Multi-dose drug delivery device and method

• US 8,679,093 B2
• Filed: 11/22/2011
• Issued: 03/25/2014
• Est. Priority Date: 11/23/2010
• Status: Active Grant

• Current Assignee: DARE MB Incorporated
• Original Assignee: MicroCHIPS Inc.
• Inventors: Farra, Robert
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): PATEL, PRITESH ASHOK
• Application Number:
  US13/302,863
• Publication Number:
  US 20120130339A1
• Time in Patent Office: 854 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1
• US Class Current: 604/890.1
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Drug delivery devices and methods are provided. The device included two or more housing units connected together end-to-end in a fixed, linear orientation, the exterior surfaces of the connected housing units defining a sidewall of the device; discrete drug dose units disposed within the housing units; degradable timing members connected to the housing units and separating the discrete dose units from one another; first and second end pieces defining opposed ends of the device such that the discrete dose units are located between the first and second end pieces within each of the housing units, wherein the device is configured to release in vivo a first of the discrete dose units following rupture of the first or second end piece, and subsequently to release in vivo a second of the discrete dose units following rupture of the degradable timing member separating the first discrete dose unit from the second discrete dose unit.

Claims

1. A drug delivery device comprising:

at least two housing units connected together end-to-end in a fixed, linear orientation, each housing unit having an exterior surface and an interior surface, the exterior surfaces of the connected housing units defining a sidewall of the device;

at least two discrete dose units, each comprising a drug formulation comprising at least one drug, wherein each of the housing units has one of the discrete dose units disposed therewithin;

at least one degradable timing member connected to the at least two housing units and separating the discrete dose units from one another;

a first end piece defining a first end of the device; and

second end piece defining a second end of the device distal to the first end of the device, the discrete dose units being located between the first and second end pieces within each of the housing units,

wherein the device, when deployed in vivo, is adapted to release a first of the at least two discrete dose units following rupture of the first or second end piece, and subsequently to release a second of the at least two discrete dose units following rupture of the at least one degradable timing member separating the first of the at least two discrete dose units from the second of the at least two discrete dose units.

2. The device of claim 1, wherein the device is substantially tubular in shape.

3. The device of claim 1, wherein the elongated body is formed of a polymer.

4. The device of claim 1, wherein at least one of the housing units is formed of a bioerodible polymer.

5. The device of claim 1, wherein the device comprises from three to fifty housing units, each housing unit having a discrete dose unit disposed therewithin.

6. The device of claim 1, wherein the device is dimensioned for insertion into a patient via a needle, trocar, catheter, or incision.

7. The device of claim 1, wherein the drug formulation is in a solid, semi-solid, or gel drug form.

8. The device of claim 1, wherein the timing member, the first end piece, and the interior surface of the housing unit to which the first end piece is connected, together define a reservoir in which one of the discrete dose units is disposed.

9. The device of claim 1, wherein one of the at least two housing units has a flange defining a shoulder, an end of the other of the at least two housing units being mated with the flange and the shoulder.

10. The device of claim 9, wherein the at least one timing member comprises a flange that is mated with the flange of the housing unit and with the interior surface of the housing unit.

11. The device of claim 1, wherein the device has a fill ratio of drug formulation volume to device volume of greater than 50%.

12. An implantable drug delivery device comprising:

at least two solid units of a drug formulation which comprises at least one drug, the solid units each having a proximal end, a distal end, and one or more longitudinal exterior surfaces therebetween;

at least one seal member sandwiched between the proximal end of a first of the at least two solid units and the distal end of a second of the at least two solid units; and

a coating layer covering at least the longitudinal exterior surfaces of the solid units, the coating layer being substantially non-permeable,

wherein release of the drug from the first or second solid unit is controlled at least in part by the in vivo disintegration of the seal member.

13. The drug delivery device of claim 12, wherein the solid units each have a cylindrically shaped exterior surface and the seal member is disk shaped.

14. The drug delivery device of claim 12, wherein the seal member comprises a bioerodible polymer.

15. The drug delivery device of claim 12, wherein the coating layer comprises a bioerodible polymer that disintegrates in vivo after the in vivo disintegration of the seal member and the release of the drug from the device.

16. The device of claim 12, wherein the device comprises from three to fifty solid units.

17. The device of claim 12, wherein the device is dimensioned for insertion into a patient via a needle, trocar, catheter, or incision.