US5308348A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Delivery devices with pulsatile effect
Assignee: Alza Corp
•
Filing: 1993-05-05
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Granted: 1994-05-03
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Expires: 2013-05-05
Abstract
Abstract Delivery devices which include a beneficial agent and an activating mechanism in separate compartments separated by a moveable partition are designed to deliver the beneficial agent in a pulsatile manner through an orifice. The pulsatile delivery is achieved by a band of resilient material which is placed over the orifice. The resilient material is sufficiently tight to substantially seal the orifice when the pressure within the device is below a threshold level while at the same time being capable of being stretched when the internal pressure exceeds the threshold.
Inventors
- 👤 Stephen M. Balaban
- 👤 James B. Pike
- 👤 Jonathan P. Smith
- 👤 Clifton A. Baile
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 22:09
CPC Classifications
A; A61; A61M; A61M5/00; A61M5/14; A61M5/142; A61M5/145; A61M5/1452; A61M5/14526; A61K; A61K9/00; A61K9/0002; A61K9/0004; A61M2005/14513; A61M2206/00; A61M2206/10
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
178 words
A delivery device for placement in an environment of use for the pulsate delivery of a beneficial agent to said environment, the device comprising: an enclosure having first and second ends and an orifice at or near said first end; a partition dividing the interior of said enclosure into a first compartment for retaining a beneficial agent and a second compartment for retaining an activating mechanism, said first and second compartments being adjacent to said first and second ends, respectively, said partition being capable of moving within said enclosure; a band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough.
Claim 2
Dependent Claim
178 words
A delivery device for placement in an environment of use for the pulsate delivery of a beneficial agent to said environment, the device comprising: an enclosure having first and second ends and an orifice at or near said first end; a partition dividing the interior of said enclosure into a first compartment for retaining a beneficial agent and a second compartment for retaining an activating mechanism, said first and second compartments being adjacent to said first and second ends, respectively, said partition being capable of moving within said enclosure; a band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough.
Claim 3
Dependent Claim
17 words
A delivery device in accordance with claim 1 wherein said resilient material is selected from elastomeric compounds.
Claim 4
Dependent Claim
18 words
A delivery device in accordance with claim 1 wherein said resilient material is selected from injection-moldable elastomeric compounds.
Claim 5
Dependent Claim
58 words
A delivery device in accordance with claim 1 wherein said activating mechanism is selected from the group consisting of an osmotic engine, a thermal system, a mechanical system, a system dependent on vapor pressure of fluid, a system dependent on chemical or electrochemical reactions, an elastomeric system, a spring-loaded chamber or piston, and a system dependent on gravity.
Claim 6
Dependent Claim
44 words
A delivery device in accordance with claim 1 wherein said environment of use is an aqueous environment, at least a portion of said enclosure of said device adjacent to said second end is permeable to moisture, and said activating mechanism is an osmotic engine.
Claim 7
Dependent Claim
72 words
A delivery device in accordance with claim 5 which further comprises a beneficial agent in said first compartment and an osmotically active agent or mixture of osmotically active agents in said second compartment, and in which said band of resilient material and said orifice are constructed such that continuous absorption of fluid from said aqueous environment causes said band to be stretched away from said orifice to release said beneficial agent intermittently.
Claim 8
Dependent Claim
18 words
A delivery device in accordance with claim 1 which further comprises a capacitance means in said second compartment.
Claim 9
Dependent Claim
14 words
A delivery device in accordance with claim 1 which further comprises a density element.
Claim 10
Independent Claim
235 words
A method for providing delivery of a beneficial agent in a pulsatile manner to an environment of use, said method comprising: 1) placing into said environment a delivery device, said device comprising: an enclosure having first and second ends and an orifice at or near said first end; a partition dividing the interior of said enclosure into a first compartment for retaining a beneficial agent and a second compartment for retaining an activating mechanism, said first and second compartments being adjacent to said first and second ends, respectively, said partition being capable of moving within said enclosure; a beneficial agent in said first compartment; a band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough; and 2) activating said activating mechanism in said device to cause said activating mechanism to generate a pressure differential within said enclosure to cause said band of resilient material to be stretched away from said orifice to release said beneficial agent intermittently.
Claim 11
Independent Claim
235 words
A method for providing delivery of a beneficial agent in a pulsatile manner to an environment of use, said method comprising: 1) placing into said environment a delivery device, said device comprising: an enclosure having first and second ends and an orifice at or near said first end; a partition dividing the interior of said enclosure into a first compartment for retaining a beneficial agent and a second compartment for retaining an activating mechanism, said first and second compartments being adjacent to said first and second ends, respectively, said partition being capable of moving within said enclosure; a beneficial agent in said first compartment; a band of resilient material on the exterior of said enclosure and covering said orifice, said resilient material being sufficiently tight to seal or substantially seal said orifice while at the same time being capable of being stretched in response to pressure generated by said activating mechanism; and a trough formed in the outer surface of the side wall of said enclosure near said first end and encircling said enclosure, wherein said orifice is located inside said trough and said band of resilient material is seated inside said trough; and 2) activating said activating mechanism in said device to cause said activating mechanism to generate a pressure differential within said enclosure to cause said band of resilient material to be stretched away from said orifice to release said beneficial agent intermittently.
Claim 12
Dependent Claim
16 words
A method in accordance with claim 9 wherein said resilient material is selected from elastomeric compounds.
Claim 13
Dependent Claim
17 words
A method in accordance with claim 9 wherein said resilient material is selected from injection-moldable elastomeric compounds.
Claim 14
Dependent Claim
57 words
A method in accordance with claim 9 wherein said activating mechanism is selected from the group consisting of an osmotic engine, a thermal system, a mechanical system, a system dependent on vapor pressure of fluid, a system dependent on chemical or electrochemical reactions, an elastomeric system, a spring-loaded chamber or piston, and a system dependent on gravity.
Claim 15
Dependent Claim
79 words
A method in accordance with claim 9 wherein said environment of use is an aqueous environment, at least a portion of said enclosure of said device adjacent to said second end is permeable to moisture, said activating mechanism is an osmotically active agent or a mixture of osmotically active agents, and said activating mechanism is activated by allowing said device to imbibe fluid from said aqueous environment through said moisture-permeable enclosure to activate said osmotically active agent or agents.
Claim 16
Dependent Claim
20 words
A method in accordance with claim 9 wherein said delivery device further comprises a capacitance means in said second compartment.
Claim 17
Dependent Claim
16 words
A method in accordance with claim 9 wherein said delivery device further comprises a density element.
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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) | 1997-05-02 | 1997-11-01 | 1998-05-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-05-02 | 2001-11-01 | 2002-05-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-05-02 | 2005-11-01 | 2006-05-03 | $7700.00 | Window Closed / Lapsed |