US6183434B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Multiple mechanical microporation of skin or mucosa
Assignee: MIDCAP FUNDING III AS SUCCESSOR IN INTEREST TO MIDCAP FINANCIAL LLC LLC
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Filing: 1997-07-03
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Granted: 2001-02-06
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Expires: 2017-07-03
Abstract
Abstract A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.
Inventors
- 👤 Jonathan A. Eppstein
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 06:24
CPC Classifications
A; A61; A61M; A61M37/00; A61M37/0015; A61B; A61B5/00; A61B5/145; A61B5/14507; A61B5/1451; A61B5/14514; A61M37/0092; A61M2037/0007; A61M2037/0023; A61M2037/0038; A61M2037/0053
Claims Analysis
Total Claims: 52
Claim 1
Independent Claim
131 words
A device for reducing the barrier properties of skin or mucosa to the delivery of a substance into the body or the withdrawal of an analyte from the body comprising: (a) a base having a lower side and an upper side; (b) a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; (c) a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and (d) a network of channels configured in the upper side of said base to interconnect said holes.
Claim 2
Independent Claim
131 words
A device for reducing the barrier properties of skin or mucosa to the delivery of a substance into the body or the withdrawal of an analyte from the body comprising: (a) a base having a lower side and an upper side; (b) a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; (c) a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and (d) a network of channels configured in the upper side of said base to interconnect said holes.
Claim 3
Dependent Claim
12 words
The device of claim 1 wherein said device is fabricated by microlithography.
Claim 4
Dependent Claim
23 words
The device of claim 1 wherein said device is fabricated of a material selected from the group consisting of silicon, metal, and plastic.
Claim 5
Dependent Claim
18 words
The device of claim 1 wherein said puncturing member is in the shape of a pyramid or wedge.
Claim 6
Dependent Claim
21 words
The device of claim 4 wherein said pyramid or wedge comprises sharp edges having corner radii of less than 1 μm.
Claim 7
Dependent Claim
24 words
The device of claim 1 wherein said puncturing member is configured for puncturing said skin or mucosa to a depth of about 30-50 μm.
Claim 8
Dependent Claim
27 words
The device of claim 1 wherein said plurality of puncturing members occupy up to about 50% of the surface area of the lower surface of the base.
Claim 9
Dependent Claim
20 words
The device of claim 1 wherein said puncturing member has a dimension at a base thereof of about 10-50 μm.
Claim 10
Dependent Claim
18 words
The device of claim 1 wherein said each of said holes is positioned adjacent to a puncturing member.
Claim 11
Dependent Claim
17 words
The device of claim 1 wherein said network of channels further comprises a reservoir for holding liquid.
Claim 12
Dependent Claim
11 words
The device of claim 1 wherein said base is substantially planar.
Claim 13
Dependent Claim
29 words
The device of claim 1 further comprising a mechanism for producing vibrations, said vibrations for facilitating efficient and non-traumatic penetration of the puncturing members into the skin or mucosa.
Claim 14
Dependent Claim
15 words
The device of claim 12 wherein said mechanism for producing vibrations comprises a piezo-electric transducer.
Claim 15
Dependent Claim
24 words
The device of claim 12 wherein said mechanism for producing vibrations produces vibrations in the range of about 2000 Hz to about 100 MHz.
Claim 16
Dependent Claim
22 words
The device of claim 1 further comprising an external reservoir for holding a liquid drug composition to be delivered to the body.
Claim 17
Dependent Claim
27 words
The device of claim 15 further comprising a mechanism for limiting the rate of drug delivery, said mechanism positioned between the external reservoir and the puncturing members.
Claim 18
Dependent Claim
10 words
The device of claim 1 wherein said device is disposable.
Claim 19
Independent Claim
161 words
A method for reducing the barrier function of skin or mucosa to the delivery of substances into a body or withdrawal of analytes out of the body, comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof.
Claim 20
Independent Claim
161 words
A method for reducing the barrier function of skin or mucosa to the delivery of substances into a body or withdrawal of analytes out of the body, comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof.
Claim 21
Dependent Claim
12 words
The method of claim 18 wherein said device is fabricated by microlithography.
Claim 22
Dependent Claim
23 words
The method of claim 18 wherein said device is fabricated of a material selected from the group consisting of silicon, metal, and plastic.
Claim 23
Dependent Claim
18 words
The method of claim 18 wherein said puncturing member is in the shape of a pyramid or wedge.
Claim 24
Dependent Claim
21 words
The method of claim 21 wherein said pyramid or wedge comprises sharp edges having corner radii of less than 1 μm.
Claim 25
Dependent Claim
24 words
The method of claim 18 wherein said puncturing member is configured for puncturing said skin or mucosa to a depth of about 30-50 μm.
Claim 26
Dependent Claim
27 words
The method of claim 18 wherein said plurality of puncturing members occupy up to about 50% of the surface area of the lower surface of the base.
Claim 27
Dependent Claim
20 words
The method of claim 18 wherein said puncturing member has a dimension at a base thereof of about 10-50 μm.
Claim 28
Dependent Claim
18 words
The method of claim 18 wherein said each of said holes is positioned adjacent to a puncturing member.
Claim 29
Dependent Claim
17 words
The method of claim 18 wherein said network of channels further comprises a reservoir for holding liquid.
Claim 30
Dependent Claim
11 words
The method of claim 18 wherein said base is substantially planar.
Claim 31
Dependent Claim
29 words
The method of claim 18 further comprising a mechanism for producing vibrations, said vibrations for facilitating efficient and non-traumatic penetration of the puncturing members into the skin or mucosa.
Claim 32
Dependent Claim
15 words
The method of claim 29 wherein said mechanism for producing vibrations comprises a piezo-electric transducer.
Claim 33
Dependent Claim
24 words
The method of claim 29 wherein said mechanism for producing vibrations produces vibrations in the range of about 2000 Hz to about 100 MHz.
Claim 34
Dependent Claim
22 words
The method of claim 18 further comprising an external reservoir for holding a liquid drug composition to be delivered to the body.
Claim 35
Dependent Claim
27 words
The method of claim 32 further comprising a mechanism for limiting the rate of drug delivery, said mechanism positioned between the external reservoir and the puncturing members.
Claim 36
Dependent Claim
10 words
The method of claim 18 wherein said device is disposable.
Claim 37
Independent Claim
206 words
A method of transdermal or transmucosal monitoring of a selected analyte in a body comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes, said network of channels including a reservoir; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof resulting in seepage of interstitial fluid to the surface of said skin or mucosa such that interstitial fluid moves by capillary action through the holes, through the channels, to the reservoir; (c) collecting the interstitial fluid from the reservoir; and (d) analyzing the interstitial fluid with respect to the selected analyte.
Claim 38
Independent Claim
206 words
A method of transdermal or transmucosal monitoring of a selected analyte in a body comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes, said network of channels including a reservoir; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof resulting in seepage of interstitial fluid to the surface of said skin or mucosa such that interstitial fluid moves by capillary action through the holes, through the channels, to the reservoir; (c) collecting the interstitial fluid from the reservoir; and (d) analyzing the interstitial fluid with respect to the selected analyte.
Claim 39
Dependent Claim
18 words
The method of claim 35 further comprising applying suction to increase the rate of collection of interstitial fluid.
Claim 40
Dependent Claim
25 words
The method of claim 35 further comprising applying ultrasonic vibrations to the skin or mucosa to increase the rate of collection of the selected analyte.
Claim 41
Dependent Claim
19 words
The method of claim 37 wherein said ultrasonic vibrations are modulated in frequency, intensity, phase, or a combination thereof.
Claim 42
Dependent Claim
21 words
The method of claim 38 wherein said ultrasonic vibrations are in the range of about 2000 Hz to about 100 MHz.
Claim 43
Dependent Claim
19 words
The method of claim 35 wherein movement of interstitial fluid by capillary action is enhanced by applying ultrasonic vibrations.
Claim 44
Dependent Claim
11 words
The method of claim 35 wherein said selected analyte is glucose.
Claim 45
Dependent Claim
18 words
The method of claim 35 further comprising applying an anticoagulant to inhibit obstruction of the holes or channels.
Claim 46
Independent Claim
192 words
A method of transdermally or transmucosally delivering a drug in liquid form to a body comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes, said network of channels including a reservoir; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof; (c) supplying the drug to said reservoir such that said drug moves from the reservoir, through the channels and holes to the site of the punctures of the skin or mucosa and thus into the body.
Claim 47
Independent Claim
192 words
A method of transdermally or transmucosally delivering a drug in liquid form to a body comprising: (a) providing a device comprising: a base having a lower side and an upper side; a plurality of puncturing members extending from the lower side of the base, said puncturing members configured for puncturing said skin or mucosa to a depth sufficient to reduce the barrier properties thereof without significantly damaging underlying tissues; a plurality of holes extending from the lower side of the base to the upper side of the base, said holes configured for permitting a liquid to move therethrough by capillary action; and a network of channels configured in the upper side of said base to interconnect said holes, said network of channels including a reservoir; (b) contacting said device with the skin or mucosa such that said plurality of puncturing members puncture the skin or mucosa to a depth sufficient to reduce the barrier properties thereof; (c) supplying the drug to said reservoir such that said drug moves from the reservoir, through the channels and holes to the site of the punctures of the skin or mucosa and thus into the body.
Claim 48
Dependent Claim
21 words
The method of claim 43 further comprising applying pressure to increase the rate of delivery of the drug to the body.
Claim 49
Dependent Claim
27 words
The method of claim 43 further comprising applying ultrasonic vibrations to the skin or mucosa to increase the rate of delivery of the drug to the body.
Claim 50
Dependent Claim
19 words
The method of claim 45 wherein said ultrasonic vibrations are modulated in frequency, intensity, phase, or a combination thereof.
Claim 51
Dependent Claim
21 words
The method of claim 45 wherein said ultrasonic vibrations are in the range of about 2000 Hz to about 100 MHz.
Claim 52
Dependent Claim
31 words
The method of claim 43 wherein said drug in liquid form further comprises an anti-irritant, antiseptic, or analgesic to reduce trauma to the body due to the application of the device.
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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) | 2004-02-06 | 2004-08-07 | 2005-02-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-02-06 | 2008-08-07 | 2009-02-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-02-06 | 2012-08-07 | 2013-02-06 | $7700.00 | Window Closed / Lapsed |