Implantable drug delivery device

• US 7,052,488 B2
• Filed: 08/08/2003
• Issued: 05/30/2006
• Est. Priority Date: 11/17/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Uhland, Scott A.
• Primary Examiner(s): Tapolcai, William E
• Application Number:
  US10/637,319
• Publication Number:
  US 20040034332A1
• Time in Patent Office: 1,026 Days
• Field of Search: 604/890.1, 604/501, 604/502, 604/891.1, 604/892.1, 604/288.01, 604/288.04, 604/131, 216/2, 424422-424
• US Class Current: 604/891.1
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/005 the dosages being arranged on a cylindrical surface
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances

Abstract

Implantable devices for controlled delivery of a drug are provided which include a substrate; at least two reservoirs in the substrate, each reservoir having an opening; at least one therapeutic agent in each of the reservoirs; a reservoir cap sealing each opening; a mechanical rupturing mechanism which moves into contact with and ruptures the reservoir cap to permit release the therapeutic agent from the reservoir through the opening; and a mixing chamber adjacent the reservoirs, wherein upon release of the therapeutic agent from at least one of the reservoirs, the therapeutic agent is combined with a carrier fluid in the mixing chamber and then transported to a delivery site in a human or animal.

Claims

1. An implantable device for controlled delivery of a drug comprising:

a substrate;

at least two reservoirs in the substrate, each reservoir having an opening;

at least one therapeutic agent in each of the reservoirs;

a reservoir cap sealing each opening;

a mechanical rupturing mechanism which comprises a structure which moves, at the time selected for rupture of a reservoir cap, from a non-contacting position outside of the reservoir into contact with and ruptures the reservoir cap to permit release of the therapeutic agent from the reservoir through the opening; and

a mixing chamber adjacent the reservoirs, wherein upon release of the therapeutic agent from at least one of the reservoirs, the therapeutic agent is combined with a carrier fluid in the mixing chamber and then transported to a delivery site in a human or animal.

2. The device of claim 1, wherein the mechanical rupturing mechanism comprises an array of cantilevers adapted to forcefully contact the surface of the reservoir cap to rupture the reservoir cap.

3. The device of claim 1, wherein the reservoir cap comprises a thin film formed of a metal, a polymer, or a combination thereof.

4. The device of claim 1, wherein the therapeutic agent is in a matrix formed of degradable material or a material which releases the therapeutic agent by diffusion out of or disintegration of the matrix.

5. The device of claim 4, wherein the matrix comprises a polymer is selected from the group consisting of polyamides, polyesters, polyanhydrides, polyorthoesters, and polycarbonates.

6. The device of claim 1, wherein the carrier fluid comprises a natural biological fluid.

7. The device of claim 1, wherein the therapeutic agent is transported to the delivery site by concentration gradient driven diffusion.

8. The device of claim 1, wherein the therapeutic agent is a protein.

9. The device of claim 1, wherein the therapeutic agent is a hormone.

10. The device of claim 1, wherein the therapeutic agent is a nucleic acid.

11. A method of delivering a drug to a human or animal patient in need thereof comprising:

implanting in the patient a device which comprises a substrate, at least two reservoirs in the substrate, each reservoir having an opening, at least one therapeutic agent in each of the reservoirs, a reservoir cap sealing each opening, and a mixing chamber adjacent the reservoirs; and

activating a mechanical rupturing mechanism which comprises a structure which moves from a non-contacting position outside of the reservoir into contact with the reservoir cap, rupturing the reservoir cap to permit release of the therapeutic agent from the reservoir through the opening such that the therapeutic agent combines with a carrier fluid in the mixing chamber and then is transported to a delivery site in the patient.

12. The method of claim 11, wherein the cater fluid is a natural biological fluid and the therapeutic agent is transported to the delivery site by concentration gradient driven diffusion.

13. The method of claim 11, wherein the mechanical rupturing mechanism comprises an array of cantilevers adapted to forcefully contact the surface of the reservoir cap to rupture the reservoir cap.

14. The method of claim 11, wherein the reservoir cap comprises a thin film formed of a metal, a polymer) or a combination thereof.