Intradermal drug delivery device and method for intradermal delivery of drugs

• US 5,527,288 A
• Filed: 01/18/1994
• Issued: 06/18/1996
• Est. Priority Date: 12/13/1990
• Status: Expired due to Term

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Medical Technologies (Ireland) Ltd. (Perrigo Company PLC)
• Inventors: Gross, Joseph, Kelly, John G.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/183,482
• Time in Patent Office: 882 Days
• Field of Search: 604/140-143, 604/145, 604/147, 604/890.1, 604/892.1
• US Class Current: 604/140
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

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.

Claims

1. 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.

2. 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.

3. The device according to claim 1, wherein the lower surface of the housing is flat.

4. 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.

5. The device according to claim 1, wherein the lower surface of the housing is provided with a protuberance from which the needle projects.

6. 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.

7. 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.

8. The device according to claim 7, wherein the needle projects outwards of the housing by 0.3-1.0 mm.

9. The device according to claim 1, wherein the drug reservoir, when filled, has a volume from about 0.2 ml to 10.0 ml.

10. The device according to claim 9, wherein the drug reservoir has a volume from about 0.5 ml to 3.0 ml.

11. 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.

12. The device according to claim 11, wherein the gas generator is an electrolytic cell.

13. 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.

14. 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.

15. 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.

16. 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.

17. The device according to claim 16, wherein all the drug reservoirs communicate in series with the outlet cavity.

18. The device according to claim 16, wherein all the drug reservoirs communicate in parallel with the outlet cavity.

19. The device according to claim 1, wherein the housing includes a plurality of drug reservoirs, each having a single hollow needle associated therewith.

20. The device according to claim 19, wherein each drug reservoir delivers a different liquid drug to the subject.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. The device according to claim 1, further comprising at least one liquid drug contained in the drug reservoir.

30. 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.

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. 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.