Microneedles, microneedle arrays, and systems and methods relating to same

• US 8,361,037 B2
• Filed: 09/19/2002
• Issued: 01/29/2013
• Est. Priority Date: 09/19/2001
• Status: Expired due to Fees

• Current Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Original Assignee: Valeritas, Inc. (Zealand Pharma A/S)
• Inventors: Gonnelli, Robert R.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US10/251,480
• Publication Number:
  US 20030135167A1
• Time in Patent Office: 3,785 Days
• Field of Search: 604/80, 604/85, 604/93.01, 604/173, 604/180, 604/183, 604/184, 604/187, 604/191, 604/192, 604/239, 604/258, 604/261, 604/272, 604/890.1, 424/449, 424/483
• US Class Current: 604/239
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The microneedle devices disclosed herein in some embodiments include a substrate; one or more microneedles; and, optionally, a reservoir for delivery of drugs or collection of analyte, as well as pump(s), sensor(s), and/or microprocessor(s) to control the interaction of the foregoing.

Claims

1. A microneedle device, comprising

a first layer formed into the shape of a microneedle and comprising a first material suitable for piercing tissue,

a continuous second layer disposed on and internal to the first layer and capable of acting as an electrical insulator, and

a continuous third layer disposed on and internal to the second layer and capable of conducting electrical charge,

wherein said microneedle has a length of between about 10 microns and 1 mm and permits passage of fluid and/or solid materials through the microneedle, and

wherein the second layer is continuously disposed over the entire first layer.

2. A microneedle according to claim 1, wherein the first layer comprises a metal material.

3. A microneedle according to claim 2, wherein the metal material is selected from the group consisting of:

copper, silver, tungsten, gold, platinum, palladium, nickel and titanium.

4. A microneedle according to claim 1, wherein the second layer comprises an electrically insulating material.

5. A microneedle according to claim 4, wherein the insulating material is selected from the group consisting of silicon, glass, plastic, air ceramic, oxidized silicon and mylar.

6. A microneedle according to claim 1, wherein the third layer comprises a metal.

7. A microneedle according to claim 6, wherein the metal is selected from the group consisting of copper, silver, tungsten, gold, platinum, palladium, nickel and titanium.

8. A microneedle according to claim 1, wherein at least one of the second and third layers comprises material deposited onto the first layer.

9. A microneedle according to claim 1, wherein at least one of the layers comprises layers formed of a doped material.

10. A microneedle according to claim 1, wherein at least one of the layers comprises a layer formed of sputtered material.

11. A microneedle according to claim 1, further comprising a layer having an electron transfer agent.

12. A microneedle according to claim 1, wherein the electron transfer agent comprises an enzyme.

13. A microneedle device according to claim 1, wherein the first layer and the continuous third layer are coupled to a sensor for detecting a change in an electrical parameter that is caused at least in part by delivery of an agent.

14. A microneedle device according to claim 1, wherein the microneedle comprises the sensor to which the first layer and the continuous third layer are coupled.

15. A microneedle according to claim 1, further comprising an agent, wherein the agent is disposed on the third layer and further wherein the agent comprises an agent for activating a detectable change in an electrical parameter upon delivery into or across the biological barrier.

16. A method for withdrawing a third material from across a biological barrier, comprising withdrawing the third material with the microneedle device of claim 1.

17. The method of claim 16, wherein the third material is an interstitial fluid from a tissue.

18. The method of claim 17, wherein the interstitial fluid is removed from the epidermis across the stratum corneum for assaying concentration of glucose, lactate, oxygen, pH, alcohol, tobacco metabolites, or illegal drugs.

19. The method of claim 16, wherein the microneedle is sheared off the microneedle device after penetrating the biological barrier and withdrawing the material.

20. A method for transporting a second material into or across a biological barrier, comprising

delivering the second material with a microneedle device comprising a first layer formed into the shape of a microneedle and comprising a first material suitable for piercing tissue, a continuous second layer disposed on and internal to the first layer and capable of acting as an electrical insulator, and a continuous third layer disposed on and internal to the second layer and capable of conducting electrical charge, wherein said microneedle has a length of between about 10 microns and 1 mm and permits passage of fluid and/or solid materials through the microneedle, and wherein the second layer is continuously disposed over the entire first layer.

21. The method of claim 20, wherein the biological barrier is skin, blood-brain barrier, mucosal tissue, blood vessel, lymphatic vessel, cell membrane, eye, conjunctiva, sclera, cornea, lining of the gastrointestinal tract, or lining of the blood vessels.

22. The method of claim 20, wherein the biological barrier is in a human, a non-human animal, a plant, an insect, a bacterium, a yeast, a fungus, or an embryo.

23. The method of claim 20, wherein the microneedle device is applied to the biological barrier internally with the aid of a catheter or laproscope.

24. The method of claim 20, wherein the microneedle device is surgically implanted.

25. The method of claim 20, wherein the second material comprises a bioactive agent selected from proteins, enzymes, polysaccharides, polynucleotide molecules, and synthetic organic and inorganic compounds.

26. The method of claim 20, wherein the second material comprises insulin.

27. The method of claim 20, wherein the second material comprises anti-infectives, hormones, growth regulators, anticoagulants, drugs regulating cardiac action or blood flow, and drugs for pain control.

28. The method of claim 20, wherein the second material is useful to treat:

osteoporosis;

rheumatoid arthritis;

anemia;

postoperative and chronic pain;

low white blood cell counts resulting from chemotherapy;

diabetes;

multiple sclerosis;

local anesthesia; and

migraine headaches.

29. The method of claim 20, wherein the second material is delivered as a variety of therapeutically useful rates.

30. The method of claim 20, wherein the microneedle is sheared off the microneedle device after penetrating the biological barrier and transporting the material.