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US5310404A Expired / Lapsed US ⏱️ 0.0 years remaining

Iontophoretic delivery device and method of hydrating same

Assignee: Alza Corp
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Filing: 1992-06-01
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Granted: 1994-05-10
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Expires: 2012-06-01
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Abstract

Abstract A dry-state iontophoretic drug delivery device (10, 30) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a sealed liquid-containing pouch (21, 22) is provided in each electrode assembly (8, 9). Water or other liquid (20) is released from the pouch (21, 22) by pulling a tab (27, 28) attached to a portion (25, 26) of the pouch (21, 22) which is capable of being torn or ripped in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10, 30). In another embodiment, the device (30) is held in a package (32). The device (30) has pouches (21, 22) which release their liquid contents automatically upon removal of the device (30) from the package (32). In yet another embodiment, the device (40) is held in a package (42) having a compression zone (46). The pouches (21, 22) must be moved through the compression zone (46) when removing the device (40) from the package (42). Compression causes the pouches (21, 22) to rupture and release the hydrating liquid (20).

Inventors

  • 👤 J. Richard Gyory
  • 👤 John R. Perry

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-07 12:11
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/0404; A61N1/0408; A61N1/0428; A61N1/0448; A61N1/0432; A61N1/0436

Claims Analysis

Total Claims: 29
Claim 1
Independent Claim 157 words
A device including an electrode assembly for an electrically powered iontophoretic agent delivery, the electrode assembly comprising: a) a reservoir including a substantially non-hydrated hydratable matrix adapted to contain an agent to be delivered through a body surface, said reservoir being electrically connected to a power source; b) a sealed container in fluid communication with the reservoir, the container containing a liquid for hydrating the substantially non-hydrated matrix, at least a portion of the container comprising a liquid impermeable material which is capable of being ripped or torn, the material having an inner surface which is exposed to the sealed hydrating liquid and an outer surface; and c) a tab having one portion attached to the outer surface of the liquid impermeable material without passing through said material, whereby pulling the tab relative to the liquid impermeable material causes the material to rip or tear and release the liquid from the container and into the reservoir matrix.
Claim 2
Independent Claim 157 words
A device including an electrode assembly for an electrically powered iontophoretic agent delivery, the electrode assembly comprising: a) a reservoir including a substantially non-hydrated hydratable matrix adapted to contain an agent to be delivered through a body surface, said reservoir being electrically connected to a power source; b) a sealed container in fluid communication with the reservoir, the container containing a liquid for hydrating the substantially non-hydrated matrix, at least a portion of the container comprising a liquid impermeable material which is capable of being ripped or torn, the material having an inner surface which is exposed to the sealed hydrating liquid and an outer surface; and c) a tab having one portion attached to the outer surface of the liquid impermeable material without passing through said material, whereby pulling the tab relative to the liquid impermeable material causes the material to rip or tear and release the liquid from the container and into the reservoir matrix.
Claim 3
Dependent Claim 49 words
The electrode assembly of claim 1, including a release liner covering a body contacting surface of the electrode assembly, the release liner being attached to the tab, whereby removal of the release liner from the electrode assembly causes the tab to be pulled relative to the liquid impermeable material.
Claim 4
Dependent Claim 14 words
The device of claim 2, wherein the release liner comprises a siliconized polyester sheet.
Claim 5
Dependent Claim 144 words
A packaged electrically powered iontophoretic agent delivery device having a donor electrode assembly, a counter electrode assembly and a power source electrically connected to the donor and counter electrode assemblies, at least one of the electrode assemblies comprising: a) a reservoir including a substantially non-hydrated, hydratable matrix adapted to contain an agent to be delivered through a body surface; and b) a sealed container in fluid communication with the reservoir, the container containing a liquid for hydrating the substantially non-hydrated matrix, at least a portion of the container comprising a liquid impermeable, breakable material; wherein the device is held in a package before use, said package having means operatively associated with the liquid impermeable material whereby removal of the device from the package causes said means to break the liquid impermeable material, thereby releasing the liquid from the container and into the reservoir matrix.
Claim 6
Dependent Claim 144 words
A packaged electrically powered iontophoretic agent delivery device having a donor electrode assembly, a counter electrode assembly and a power source electrically connected to the donor and counter electrode assemblies, at least one of the electrode assemblies comprising: a) a reservoir including a substantially non-hydrated, hydratable matrix adapted to contain an agent to be delivered through a body surface; and b) a sealed container in fluid communication with the reservoir, the container containing a liquid for hydrating the substantially non-hydrated matrix, at least a portion of the container comprising a liquid impermeable, breakable material; wherein the device is held in a package before use, said package having means operatively associated with the liquid impermeable material whereby removal of the device from the package causes said means to break the liquid impermeable material, thereby releasing the liquid from the container and into the reservoir matrix.
Claim 7
Dependent Claim 52 words
The device of claim 4, wherein the liquid impermeable material is capable of being ripped or torn and the means operatively associated with the liquid impermeable material comprises a tab, one portion of said tab being attached to the liquid impermeable material, another portion of the tab being attached to the package.
Claim 8
Dependent Claim 25 words
The device of claim 1 or 5, wherein the liquid impermeable material has a tear strength in the range of about 0.2 to 2.3 kg.
Claim 9
Dependent Claim 73 words
The device of claim 4, wherein the liquid impermeable material is rupturable when the pressure within the container reaches a predetermined level and the means operatively associated with the rupturable material comprises a compression zone within the package, whereby removal of the device from the package causes the container to move into the compression zone and increase the pressure within the container to a level at least as great as the predetermined level.
Claim 10
Dependent Claim 34 words
The device of claim 1 or 4, wherein the liquid impermeable material is selected from the group consisting of metal foils, polymer films, metal deposited on a polymer film and metal foil/polymer film laminates.
Claim 11
Dependent Claim 27 words
The device of claim 1 or 4, including liquid flow control means for directing the flow of liquid released from the container to the non-hydrated reservoir matrix.
Claim 12
Dependent Claim 21 words
The device of claim 1 or 4, wherein the agent is unstable or becomes degraded in the presence of the liquid.
Claim 13
Dependent Claim 22 words
The device of claim 1 or 4 wherein the electrode assembly is a donor electrode assembly and the agent is a drug.
Claim 14
Dependent Claim 12 words
The device of claim 1 or 4, wherein the liquid comprises water.
Claim 15
Dependent Claim 21 words
The device of claim 1 or 4, wherein the liquid comprises an aqueous solution or an aqueous suspension of the drug.
Claim 16
Dependent Claim 22 words
The device of claim 1 or 4, wherein the electrode assembly is a counter electrode assembly and the agent is an electrolyte.
Claim 17
Dependent Claim 21 words
The device of claim 1 or 4, wherein the liquid comprises an aqueous solution or an aqueous suspension of the electrolyte.
Claim 18
Dependent Claim 33 words
The device of claim 1 or 4, including a liquid flow control means associated with the sealed container for directing the flow of liquid released from the container to the non-hydrated reservoir matrix.
Claim 19
Dependent Claim 24 words
The device of claim 16, wherein the liquid flow control means comprises a liquid wicking material positioned between the sealed container and the reservoir.
Claim 20
Dependent Claim 37 words
The device of claim 16, wherein the reservoir is electrically connected to the power source through an intermediate current distributing electrode and the liquid flow control means comprises one or more liquid conveying pathways through the electrode.
Claim 21
Dependent Claim 40 words
The device of claim 16, wherein the reservoir is electrically connected to the power source through an intermediate current distributing electrode and the liquid flow control means comprises one or more liquid conveying grooves in a surface of the electrode.
Claim 22
Dependent Claim 34 words
The device of claim 1 or 4, wherein the reservoir is electrically connected to the power source through an intermediate current distributing electrode and the electrode is in the form of a metal screen.
Claim 23
Dependent Claim 49 words
The device of claim 1 or 4, wherein the reservoir is electrically connected to the power source through an intermediate current distributing electrode and the electrode comprises a hydrophobic polymer matrix containing an electrically conductive filler and about 10 to 50 vol % of a hydrophilic water conveying additive.
Claim 24
Dependent Claim 15 words
The device of claim 21, wherein the hydrophilic water conveying additive comprises a hydrophilic polymer.
Claim 25
Dependent Claim 52 words
An electrically powered iontophoretic agent delivery device including a donor electrode assembly, a counter electrode assembly and a source of electrical power which is electrically connected to the donor and counter electrode assemblies, at least one of the donor and counter electrode assemblies comprising an electrode assembly of claim 1 or 4.
Claim 26
Dependent Claim 50 words
An electrically powered iontophoretic agent delivery device including a donor electrode assembly, a counter electrode assembly and a source of electrical power which is electrically connected to the donor and counter electrode assemblies, each of the donor and counter electrode assemblies comprising an electrode assembly of claim 1 or 4.
Claim 27
Dependent Claim 20 words
The device of claim 22 or 23, wherein the donor and counter electrode assemblies are separated by an ion-impermeable separator.
Claim 28
Dependent Claim 14 words
The device of claim 1 or 4, wherein the power source comprises a battery.
Claim 29
Dependent Claim 18 words
The device of claim 1 or 4, wherein the body surface is intact skin or a mucosal membrane.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1997-05-09 1997-11-08 1998-05-10 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2001-05-09 2001-11-08 2002-05-10 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2005-05-09 2005-11-08 2006-05-10 $7700.00 Window Closed / Lapsed

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