US5533971A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Reduction of skin irritation during electrotransport
Assignee: Alza Corp
•
Filing: 1993-09-03
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Granted: 1996-07-09
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Expires: 2013-09-03
Abstract
Abstract An electrotransport delivery device utilizing reservoir buffering at a select pH ranges in order to reduce skin irritation and skin resistance is provided. Cathodic reservoirs are buffered to a pH of less than about 4, preferably to a pH in the range of about 2 to 4, while anodic reservoirs are buffered to a pH above about 4, preferably to a pH in the range of about 4 to 10. Another electrotransport delivery device utilizes a potassium sensor to monitor potassium efflux from the skin. Potassium efflux above a certain predetermined level has been found to be a precursor to skin irritation/erythema. Operation of the device is modified (eg, terminated) when the predetermined potassium efflux level is sensed.
Inventors
- 👤 Joseph B. Phipps
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 19:22
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/20; A61N1/30
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
123 words
In a method of operating an electrotransport delivery device which delivers an agent by electrotransport under the influence of an electric current through a skin site, the device comprising an anodic electrode assembly, a cathodic electrode assembly, a source of electrical power electrically connected to the electrode assemblies and an agent reservoir in at least one of the electrode assemblies; the improvement whereby electrotransport-induced irritation of the skin site can be reduced or avoided; which improvement comprises: a) monitoring potassium concentration in the cathodic electrode assembly during electrotransport agent delivery; and b) reducing the electric current flowing through the skin site when the potassium concentration reaches a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin.
Claim 2
Dependent Claim
123 words
In a method of operating an electrotransport delivery device which delivers an agent by electrotransport under the influence of an electric current through a skin site, the device comprising an anodic electrode assembly, a cathodic electrode assembly, a source of electrical power electrically connected to the electrode assemblies and an agent reservoir in at least one of the electrode assemblies; the improvement whereby electrotransport-induced irritation of the skin site can be reduced or avoided; which improvement comprises: a) monitoring potassium concentration in the cathodic electrode assembly during electrotransport agent delivery; and b) reducing the electric current flowing through the skin site when the potassium concentration reaches a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin.
Claim 3
Dependent Claim
14 words
The method of claim 1 wherein the electric current is reduced to substantially zero.
Claim 4
Dependent Claim
28 words
The method of claim 1 wherein the reduction in electrical current flowing through the skin site is produced in response to a patient-detectable signal generated by the device.
Claim 5
Dependent Claim
27 words
The method of claim 3 wherein the reduction in electrical current is obtained by removing said delivery device from the skin site in response to the signal.
Claim 6
Dependent Claim
17 words
The method of claim 4, including thereafter delivering the agent by electrotransport through said another skin site.
Claim 7
Dependent Claim
17 words
The method of claim 4 further comprising the step of reapplying the device to another skin site.
Claim 8
Dependent Claim
18 words
The method of claim 1 wherein said potassium efflux level is no greater than 10 μg/cm 2 /hr.
Claim 9
Dependent Claim
145 words
An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising: a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal alerting the patient when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin.
Claim 10
Dependent Claim
145 words
An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising: a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal alerting the patient when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin.
Claim 11
Dependent Claim
23 words
The device of claim 8 further comprising a controller for reducing the electric current applied by the device in response to said signal.
Claim 12
Dependent Claim
163 words
An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising: a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal to a controller when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin; f) a controller for reducing the electric current applied by the device in response to receiving said signal.
Claim 13
Dependent Claim
163 words
An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising: a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal to a controller when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin; f) a controller for reducing the electric current applied by the device in response to receiving said signal.
Claim 14
Dependent Claim
18 words
The device of claim 9 or 10 wherein the controller reduces the applied electric current to substantially zero.
Claim 15
Dependent Claim
20 words
The device of claim 10 or 8 wherein said signal is emitted when the potassium concentration reaches a predetermined value.
Claim 16
Dependent Claim
24 words
The device of claim 10 or 8 wherein said signal is emitted when the rate of change of potassium concentration reaches a predetermined value.
Claim 17
Dependent Claim
16 words
The device of claim 10 or 8 wherein the potassium sensor comprises a potassium sensing electrode.
Claim 18
Dependent Claim
20 words
The device of claim 10 or 8 wherein said potassium efflux level is no greater than 10 μg/cm 2 /hr.
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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) | 1999-07-09 | 2000-01-08 | 2000-07-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-07-09 | 2004-01-08 | 2004-07-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-07-09 | 2008-01-08 | 2008-07-09 | $7700.00 | Window Closed / Lapsed |