US5527288A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Intradermal drug delivery device and method for intradermal delivery of drugs
Assignee: Alkermes Pharma Ireland Ltd
•
Filing: 1994-01-18
•
Granted: 1996-06-18
•
Expires: 2014-01-18
Abstract
Abstract An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin includes a housing having a lower surface provided with an adhesive coating for adhering the housing to the subject's skin. An expansible-contractible chamber within the housing defines a reservoir which is expanded upon being filled with the drug and contracted to dispense the drug. A hollow needle extends through the lower surface of the housing and has an inner end which communicates with the reservoir and an outer end which projects outwardly of the housing a short distance to penetrate through the epidermis and into the dermis of the subject's skin when the housing is adhered thereto. The device permits delivery of drugs of relatively large molecular size and at slow rates which can be precisely controlled. A method of delivering a liquid drug intradermally includes adhering the intradermal delivery device to the skin of the subject and activating the means for actively discharging the at least one drug from the reservoir to the subject's skin via the needle.
Inventors
- 👤 Joseph Gross
- 👤 John G. Kelly
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 23:25
CPC Classifications
A; A61; A61M; A61M5/00; A61M5/14; A61M5/142; A61M5/14244; A61M5/14248; A61M5/145; A61M5/14586; A61M5/14593; A61N; A61N1/00; A61N1/18; A61N1/20; A61N1/30; A61N1/303; A61M2005/14252; A61M2005/14268; A61M37/00; A61M37/0015; A61M2037/0023
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
188 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing, wherein the reservoir is in the form of an expansible-contractible chamber which is expanded when filled with the drug and which can be contracted to dispense the drug therefrom; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle; wherein the lower surface is shaped such that when it is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip.
Claim 2
Dependent Claim
188 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing, wherein the reservoir is in the form of an expansible-contractible chamber which is expanded when filled with the drug and which can be contracted to dispense the drug therefrom; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle; wherein the lower surface is shaped such that when it is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip.
Claim 3
Dependent Claim
24 words
The device according to claim 1, wherein the means for affixing the housing in position comprises a pressure-adhesive coating on the lower surface thereof.
Claim 4
Dependent Claim
15 words
The device according to claim 1, wherein the lower surface of the housing is flat.
Claim 5
Dependent Claim
28 words
The device according to claim 1, wherein the lower surface of the housing has a convex shape and the hollow needle extends from the center of the convexity.
Claim 6
Dependent Claim
23 words
The device according to claim 1, wherein the lower surface of the housing is provided with a protuberance from which the needle projects.
Claim 7
Dependent Claim
29 words
The device according to claim 1, wherein the lower surface of the housing is of a conical shape and the hollow needle extends from the apex of the cone.
Claim 8
Dependent Claim
32 words
The device according to claim 1, wherein the needle projects outwards of the housing by 0.3-3.0 mm and has an outer diameter of 0.1-0.2 mm and an inner diameter of 0.05-0.075 mm.
Claim 9
Dependent Claim
17 words
The device according to claim 7, wherein the needle projects outwards of the housing by 0.3-1.0 mm.
Claim 10
Dependent Claim
22 words
The device according to claim 1, wherein the drug reservoir, when filled, has a volume from about 0.2 ml to 10.0 ml.
Claim 11
Dependent Claim
20 words
The device according to claim 9, wherein the drug reservoir has a volume from about 0.5 ml to 3.0 ml.
Claim 12
Dependent Claim
39 words
The device according to claim 1, wherein the means for actively discharging the drug comprises an electrically controlled gas generator within the housing for generating a gas to contract the drug reservoir in order to discharge the drug therefrom.
Claim 13
Dependent Claim
14 words
The device according to claim 11, wherein the gas generator is an electrolytic cell.
Claim 14
Dependent Claim
32 words
The device according to claim 11, further comprising a start button which is depressible in order to energize the gas generator and thereby to start discharging the drug from the drug reservoir.
Claim 15
Dependent Claim
31 words
The device according to claim 11, further comprising an electronic circuit for controlling the time and rate of gas generation, thereby controlling the discharge of the drug from the drug reservoir.
Claim 16
Dependent Claim
26 words
The device according to claim 14, wherein the electronic circuit comprises a microprocessor which is programmable with respect to the time and rate of gas generation.
Claim 17
Dependent Claim
38 words
The device according to claim 11, wherein the housing includes a plurality of drug reservoirs, each reservoir being contractible by a separate gas generator and communicating with an outlet cavity with which the single hollow needle also communicates.
Claim 18
Dependent Claim
18 words
The device according to claim 16, wherein all the drug reservoirs communicate in series with the outlet cavity.
Claim 19
Dependent Claim
18 words
The device according to claim 16, wherein all the drug reservoirs communicate in parallel with the outlet cavity.
Claim 20
Dependent Claim
23 words
The device according to claim 1, wherein the housing includes a plurality of drug reservoirs, each having a single hollow needle associated therewith.
Claim 21
Dependent Claim
18 words
The device according to claim 19, wherein each drug reservoir delivers a different liquid drug to the subject.
Claim 22
Dependent Claim
34 words
The device according to claim 1, wherein the housing further includes a sensor for detecting a condition in the body of the subject and for controlling the delivery of the drug in response thereto.
Claim 23
Dependent Claim
31 words
The device according to claim 21, wherein the sensor is a temperature sensor for sensing the temperature of the subject and for controlling the delivery of the drug in response thereto.
Claim 24
Dependent Claim
33 words
The device according to claim 21, wherein the sensor is a pulse rate sensor for sensing the pulse rate of the subject and for controlling the delivery of the drug in response thereto.
Claim 25
Dependent Claim
33 words
The device according to claim 21, wherein the sensor is a blood glucose sensor for sensing the blood glucose level of the subject and controlling the delivery of the drug in response thereto.
Claim 26
Dependent Claim
32 words
The device according to claim 21, wherein the sensor is a blood pressure sensor for sensing the blood pressure of the subject and controlling the delivery of the drug in response thereto.
Claim 27
Dependent Claim
34 words
The device according to claim 21, wherein the sensor is a pH sensor for sensing the pH of a body fluid of the subject and controlling the delivery of the drug in response thereto.
Claim 28
Dependent Claim
33 words
The device according to claim 1, which further comprises a membrane which is permeable to the liquid drug and impermeable to solid impurities, the membrane covering the inner end of the hollow needle.
Claim 29
Dependent Claim
44 words
The device according to claim 29, wherein the drug is selected from the group consisting of peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant agents, anti-emetic agents, cardiovascular agents, anti-hypertensive agents, narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, prostaglandins and antidiuretic agents.
Claim 30
Dependent Claim
18 words
The device according to claim 1, further comprising at least one liquid drug contained in the drug reservoir.
Claim 31
Dependent Claim
96 words
A method of delivering a biologically effective amount of at least one liquid drug Intradermally to a subject, comprising the steps of: (1) affixing the intradermal drug delivery device according to claim 1 to the skin of the subject such that the needle penetrates through the epidermis and into the dermis, wherein the drug reservoir contains a biologically effective amount of at least one liquid drug; and (2) activating the means for actively discharging the at least one drug so as to deliver a biologically effective amount of the at least one drug to the subject.
Claim 32
Dependent Claim
40 words
The method according to claim 30, wherein the drug is selected from the group consisting of peptides, proteins, hormones, analgesics, anti-migraine agents, anti-coagulant agents, anti-emetic agents, cardiovascular agents, anti-hypertensive agents, anti-depressants, narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives.
Claim 33
Dependent Claim
192 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle, wherein the means for actively discharging the drug comprises an electrically controlled gas generator within the housing for generating a gas to contract the drug reservoir in order to discharge the drug therefrom; wherein the lower surface is shaped such that when it Is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip.
Claim 34
Dependent Claim
192 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle, wherein the means for actively discharging the drug comprises an electrically controlled gas generator within the housing for generating a gas to contract the drug reservoir in order to discharge the drug therefrom; wherein the lower surface is shaped such that when it Is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip.
Claim 35
Dependent Claim
35 words
The device according to claim 32, wherein the reservoir is in the form of an expansible-contractible chamber which is expanded when filled with the drug and which can be contracted to dispense the drug therefrom.
Claim 36
Dependent Claim
56 words
The device according to claim 33, wherein the means for actively discharging the drug comprises a spring which is stressed by the expansion of the drug reservoir upon filling it with a drug, and which tends to return to its unstressed condition to contract the reservoir and thereby to discharge the drug via the hollow needle.
Claim 37
Dependent Claim
56 words
The device according to claim 33, wherein the means for actively discharging the drug comprises a membrane which is stressed by the expansion of the drug reservoir upon filling it with a drug, and which tends to return to its unstressed condition to contract the reservoir and thereby to discharge the drug via the hollow needle.
Claim 38
Dependent Claim
111 words
The device according to claim 33, wherein the means for actively discharging the drug comprises a deformable liquid-impermeable membrane, and a rigid liquid-permeable membrane; one side of the deformable liquid-impermeable membrane defining one side of the drug reservoir; the opposite side of the deformable liquid-impermeable membrane and one side of the rigid liquid-permeable membrane defining a saline reservoir for receiving a saline solution; the opposite side of the rigid liquid-permeable membrane defining, with a rigid part of the housing, a pure water reservoir for receiving pure water to expand the saline reservoir by osmosis, thereby to contract the drug reservoir in order to dispense the drug therefrom via the hollow needle.
Claim 39
Dependent Claim
177 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle; wherein the lower surface is shaped such that when it is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip and wherein the lower surface of the housing is provided with a protuberance from which the needle projects.
Claim 40
Dependent Claim
177 words
An intradermal drug delivery device for delivering a liquid drug to a subject via the subject's skin, comprising: (a) a housing having a lower surface for application to the skin of the subject; (b) means for affixing the housing in position with the lower surface in contact with the subject's skin; (c) a drug reservoir within the housing; (d) a single hollow needle associated with the drug reservoir extending through the lower surface, having an inner end communicating with the drug reservoir and an outer end projecting outwards a sufficient distance so as to penetrate through the epidermis and into the dermis when the housing is pressed against the skin; and (e) means for actively discharging the drug from the reservoir to the subject's skin via the needle; wherein the lower surface is shaped such that when it is pressed against the skin a substantial proportion of the pressure applied to the skin is directed through the needle tip and wherein the lower surface of the housing is provided with a protuberance from which the needle projects.
References Cited (Backward Citations)
CH60868A
Cited
US3923060A
Cited
US4140117A
Cited
US4753651A
Cited
US4522622A
Cited
EP0513879A2
Cited
US4886499A
Cited
US4734092A
Cited
WO1991000753A1
Cited
US5090963A
Cited
US5156591A
Cited
US5279544A
Cited
WO1992011879A1
Cited
US5354264A
Cited
WO1993017754A1
Cited
US5318557A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-06-18 | 1999-12-18 | 2000-06-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-06-18 | 2003-12-18 | 2004-06-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-06-18 | 2007-12-18 | 2008-06-18 | $7700.00 | Window Closed / Lapsed |