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US5848991A Expired / Lapsed US ⏱️ 0.0 years remaining

Intradermal drug delivery device and method for intradermal delivery of drugs

Assignee: Perrigo Pharma International DAC
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Filing: 1997-04-25
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Granted: 1998-12-15
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Expires: 2017-04-25
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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 Gerard Kelly

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 07:32
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; A61M37/00; Y; Y10; Y10S; Y10S977/00; Y10S977/70; Y10S977/788; Y10S977/797; Y10S977/798; Y10S977/799; Y10S977/801; Y10S977/902; Y10S977/904; Y10S977/906; Y10S977/918

Claims Analysis

Total Claims: 33
Claim 1
Independent 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 plurality of drug reservoirs within the housing; (d) an outlet cavity in communication with the plurality of drug reservoirs; (e) a single hollow needle associated with the outlet cavity extending through the lower surface, having an inner end communicating with the outlet cavity 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 (f) means for actively discharging the drug from the drug 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 outer end of the needle.
Claim 2
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 plurality of drug reservoirs within the housing; (d) an outlet cavity in communication with the plurality of drug reservoirs; (e) a single hollow needle associated with the outlet cavity extending through the lower surface, having an inner end communicating with the outlet cavity 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 (f) means for actively discharging the drug from the drug 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 outer end of the needle.
Claim 3
Dependent Claim 18 words
The device according to claim 1, wherein all the drug reservoirs communicate in series with the outlet cavity.
Claim 4
Dependent Claim 18 words
The device according to claim 1, wherein all the drug reservoirs communicate in parallel with the outlet cavity.
Claim 5
Dependent Claim 26 words
The device according to claim 1, further comprising electrical means for individually controlling the feeding of drug from the plurality of reservoirs to the outlet cavity.
Claim 6
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 7
Dependent Claim 15 words
The device according to claim 1, wherein the lower surface of the housing is flat.
Claim 8
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 9
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 10
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 11
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 12
Dependent Claim 17 words
The device according to claim 1, wherein the needle projects outwards of the housing by 0.3-1.0 mm.
Claim 13
Dependent Claim 36 words
The device according to claim 1, wherein the plurality of reservoirs are in the form of expansible-contractible chambers which are expanded when filled with the drug and which can be contracted to dispense the drug therefrom.
Claim 14
Dependent Claim 22 words
The device according to claim 1, wherein each drug reservoir when filled has a volume from about 0.2 ml to 10.0 ml.
Claim 15
Dependent Claim 20 words
The device according to claim 1, wherein each drug reservoir has a volume from about 0.5 ml to 3.0 ml.
Claim 16
Dependent Claim 42 words
The device according to claim 1, wherein the means for actively discharging the drug comprises a plurality of electrically controlled gas generators within the housing for generating gas to separately contract the plurality drug reservoirs in order to discharge the drug therefrom.
Claim 17
Dependent Claim 14 words
The device according to claim 15, wherein each gas generator is an electrolytic cell.
Claim 18
Dependent Claim 38 words
The device according to claim 15, further comprising a start button which is depressible in order to energize at least one of the plurality of gas generators and thereby to start discharging the drug from the outlet cavity.
Claim 19
Dependent Claim 45 words
The device according to claim 15, further comprising an electronic circuit for controlling the time and rate of gas generation in each of the plurality of gas generators, thereby controlling the discharge of the drug from the outlet cavity via the plurality of drug reservoirs.
Claim 20
Dependent Claim 26 words
The device according to claim 18, wherein the electronic circuit comprises a microprocessor which is programmable with respect to the time and rate of gas generation.
Claim 21
Dependent Claim 34 words
The device according to claim 1, wherein the housing further includes means for detecting a condition in the body of the subject and means for controlling the delivery of the drug in response thereto.
Claim 22
Dependent Claim 22 words
The device according to claim 20, wherein the means for detecting is a temperature sensor for sensing the temperature of the subject.
Claim 23
Dependent Claim 24 words
The device according to claim 20 wherein the means for detecting is a pulse rate sensor for sensing the pulse rate of the subject.
Claim 24
Dependent Claim 25 words
The device according to claim 20 wherein the means for detecting is a blood glucose sensor for sensing the blood glucose level of the subject.
Claim 25
Dependent Claim 24 words
The device according to claim 20 wherein the means for detecting is a blood pressure sensor for sensing the blood pressure of the subject.
Claim 26
Dependent Claim 36 words
The device according to claim 20 wherein the means for detecting 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 27
Dependent Claim 20 words
The device according to claim 1, further comprising at least one liquid drug contained in the plurality of drug reservoirs.
Claim 28
Dependent Claim 44 words
The device according to claim 26, 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 29
Dependent Claim 19 words
The device according to claim 1, where the housing further includes means for controlling the delivery of the drug.
Claim 30
Dependent Claim 14 words
The device according to claim 28, wherein the means for controlling comprises a processor.
Claim 31
Dependent Claim 98 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 throught the epidermis and into the dermis, wherein the plurality of drug reservoirs contain 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 44 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, narcotic antagonists, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, prostaglandins and antidiuretic agents.
Claim 33
Dependent Claim 16 words
The method according to claim 30, wherein at least two drugs are administered simultaneously or sequentially.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-12-14 2002-06-15 2002-12-15 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-12-14 2006-06-15 2006-12-15 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-12-14 2010-06-15 2010-12-15 $7700.00 Window Closed / Lapsed

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