Low-permeability, laser-activated drug delivery device

• US 8,911,426 B2
• Filed: 02/08/2011
• Issued: 12/16/2014
• Est. Priority Date: 02/08/2010
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: On Demand Therapeutics, Inc.
• Inventors: Coppeta, Jonathan Robert, Horne, Kenneth N., Santini, John T. Jr., Scholl, John A., Spooner, Gregory J. R., Stevenson, Cynthia L., Shams, Naveed, Poutiatine, Andrew
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US13/023,370
• Publication Number:
  US 20120035528A1
• Time in Patent Office: 1,407 Days
• Field of Search: 604/19, 604/20, 604/890.1, 604/891.1, 424422-437
• US Class Current: 604/890.1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/008 using laser
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

An implantable drug delivery device that uses multiple reservoir elements to contain and release doses of active pharmaceutical ingredients. The device includes a first shell element, which has a first enclosed cavity volume and forms a low-permeability barrier. The first shell element is configured to absorb light irradiation from a laser source, the laser irradiation causing a breach in the first shell element. A first active pharmaceutical ingredient is contained in the first enclosed cavity volume and is released when the first shell element is breached. The device also includes a second shell element, which has a second enclosed cavity volume and also forms a low-permeability barrier. A second active pharmaceutical ingredient is contained in the second enclosed cavity volume. The device also includes an envelope element containing the first and second shell elements.

Claims

1. An implantable drug delivery device comprising:

a first shell element with a first enclosed cavity volume, wherein the first shell element forms a low-permeability barrier, and wherein the first shell element is configured to absorb light irradiation from a laser source, the light irradiation causing a breach in the first shell element;

a first dose of an active pharmaceutical ingredient contained in the first enclosed cavity volume, wherein the first dose of the active pharmaceutical ingredient is released when the first shell element is breached;

a second shell element with a second enclosed cavity volume, wherein the second shell element forms a low-permeability barrier; and

a second dose of the active pharmaceutical ingredient contained in the second enclosed cavity volume, wherein the device releases time-delayed, multiple doses of the active pharmaceutical ingredient from a single laser activation of the first shell element.

2. The drug delivery device of claim 1, wherein the first shell element includes:

a cup element having an open end and a flange portion; and

an end cap element mechanically joined to the flange portion of the cup element so as to create the first enclosed cavity volume and to create a low-permeability seal preventing moisture from entering the first enclosed cavity volume.

3. The drug delivery device of claim 2, wherein the cup element and the end cap element are made from a metal material.

4. The drug delivery device of claim 3, wherein the end cap element is mechanically joined to the flange portion of the cup element using a cold welding technique and/or an ultrasonic welding technique.

5. The drug delivery device of claim 1, wherein the first shell element includes:

a tube element having two open ends, wherein the tube element is made from one of a glass, metal, or ceramic material;

a first end cap element mechanically joined to one of the open ends of the tube element;

a second end cap element mechanically joined to the other open end of the tube element,

wherein the tube element, first end cap element, and second end cap element create the first enclosed cavity volume, wherein the mechanical joining of the tube, first end cap element, and second end cap element creates a low-permeability seal preventing moisture from entering the enclosed cavity volume.

6. The drug delivery device of claim 1, wherein:

the first enclosed cavity volume is connected by one or more channels to the second enclosed cavity volume, the one or more channels allowing the transfer of the second dose of the active pharmaceutical ingredient from the second enclosed cavity volume to the first enclosed cavity volume.

7. The drug delivery device of claim 6, wherein a dissolvable, erodible or degradable barrier element is positioned to block the one or more channels and then to allow the transfer of the second dose of the active pharmaceutical ingredient from the second enclosed cavity volume to the first enclosed cavity volume and release of the second dose of active pharmaceutical ingredient through the breach in the first shell element after a period of time.

8. The drug delivery device of claim 1, further comprising:

a third dose of the active pharmaceutical ingredient contained in the drug delivery device;

a dissolvable, erodible or degradable barrier element is positioned between the first and third doses of the active pharmaceutical ingredient, wherein, the dissolvable barrier element is configured to be dissolved after a breach in the first shell element to allow the transfer of the third dose of the active pharmaceutical ingredient through the breach in the first shell element after a period of time.

9. The drug delivery device of claim 1, wherein the implantable drug delivery device has an insertion profile of less than 0.5 mm.

10. The drug delivery device of claim 1, wherein the implantable drug delivery device can be implanted by intravitreal injection.

11. The drug delivery device of claim 1, wherein said light irradiation comprises an application of energy from a laser, wherein the laser is selected from the group consisting of an argon ion laser, a Nd:

YAG laser, a frequency-doubled Nd;

YAG laser, a diode laser, a Nd;

YLF laser, a frequency-doubled Nd;

YLF laser, a krypton ion laser, a dye laser, and a helium-neon laser, a Raman-shifted Nd;

YAG laser, a Nd;

YV04 (vandate) laser, a frequency doubled Nd;

YAG laser, a frequency-doubled Nd;

YV04 (vandate) laser, a Raman-shifted Yb;

fiber laser, a Yb;

glass laser, and a Yb;

YAG laser, a frequency-doubled Yb;

fiber laser, a frequency-doubled Yb;

glass laser, and a frequency-doubled Yb;

YAG laser, and other non-linear optics crystal wavelength shifted lasers, including;

frequency doubled VECSELs, sum and difference frequency mixed laser outputs from NIR lasers such as Nd;

YV04, Nd;

YAG, using such crystals as BBO, LBO, CLBO, KTP, KD*P, and RTA.

12. The drug delivery device of claim 1, wherein the active pharmaceutical ingredient is selected from the group consisting of anti-angiogensis agents, anti-inflammatories, anti-infectives, anti-allergens, cholingergic agonists and antagonists, adrenergic agonists and antagonists, anti-glaucoma agents, agents for cataract prevention or treatment, neuroprotection agents, anti-oxidants, antihistamines, antiplatelet agents, anti-coagulants, anti-thrombic agents, anti-scarring agents, anti-proliferatives, anti-tumor agents, complement inhibitors, decongestants, vitamins, growth factors, anti-growth factor agents, gene therapy vectors, chemotherapy agents, protein kinase inhibitors, small interfering RNAs, antibodies, antibody fragments, fusion proteins, litmus family compounds, and combinations thereof.

13. The drug delivery device of claim 12, wherein said anti-growth factor agent is an antivascular endothelial growth factor (anti-VEGF) agent.

14. The drug delivery device of claim 13, wherein said anti-VEGF agent is selected from the group consisting of aflibercept (VEGF trap), bevacizumab (AVASTIN), pegaptanib sodium (MACUGEN), and ranibizumab (LUCENTIS).

15. The drug delivery device of claim 1, wherein the first dose of the active pharmaceutical ingredient is protected from ingress of water or air when implanted in an eye of a patient for a period of at least 30 days.

16. An implantable drug delivery device comprising:

an active pharmaceutical ingredient;

a metallic substrate surrounding the active pharmaceutical ingredient forming a low-permeability barrier preventing moisture from entering the active pharmaceutical ingredient;

a polymer substrate bonded to the metallic substrate forming an external coating layer on an outer surface of the metallic substrate,

wherein the metallic substrate is configured to absorb light irradiation from a laser source, the light irradiation causing a breach in the polymer and metallic substrates, and

wherein the active pharmaceutical ingredient is released when the polymer and metallic substrates are breached.