ADJUSTABLE RATE DRUG DELIVERY IMPLANTABLE DEVICE

• US 20180036522A1
• Filed: 07/27/2017
• Published: 02/08/2018
• Est. Priority Date: 08/03/2016
• Status: Active Grant

• Current Assignee: Neil S. Davey, Sonya Davey
• Original Assignee: Neil S. Davey, Sonya Davey
• Inventors: DAVEY, Neil S., DAVEY, Sonya
• Granted Patent: US 10,406,336 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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 9/0097 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: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2250/00 Specially adapted for animals
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure

Abstract

Embodiments herein relate to an implantable device comprising a casing, a semi-permeable membrane plug at or near a first end of the casing, a piston, beads, and an opening for release of the beads from the implantable device within a body of a human or an animal; wherein the implantable device is configured to be implanted within the body of the human or the animal during delivery of the beads into the body of the human or the animal; wherein the beads comprise a core and a shell with the core being enclosed by the shell and the beads contain a drug; and wherein the implantable device is configured to produce a desired flow rate of elution of the drug from the implantable device when the implantable device is implanted within the body of the human or the animal.

Claims

1. An implantable device comprising:

a casing, a semi-permeable membrane plug at or near a first end of the casing, a piston, beads, and an opening for release of the beads from the implantable device within a body of a human or an animal;

wherein the implantable device is configured to be implanted within the body of the human or the animal during delivery of the beads into the body of the human or the animal;

wherein the beads comprise a core and a shell with the core being enclosed by the shell and the beads contain a drug; and

wherein the implantable device is configured to produce a desired flow rate of elution of the drug from the implantable device when the implantable device is implanted within the body of the human or the animal.

2. The implantable device of claim 1, wherein the drug and/or the beads comprise a targeting material or a targeting molecule that binds to a certain organ, tissue, object or a specific site within the body of the human or the animal.

3. The implantable device of claim 1, wherein the shell comprises a stimuli-responsive polymer configured to break the shell, before or after implanting or attaching the implantable device in or on a body of a human or an animal, when the beads are exposed to an external stimulus.

4. The implantable device of claim 1, wherein the shell comprises a first material and a second material;

wherein the first material comprises a metal-containing material or a first biodegradable material;

wherein the second material comprises a second biodegradable material;

wherein the first material is distributed in the second material;

wherein the first material is configured to create pores in the second material; and

wherein the pores allow the drug to flow from within the beads to outside the beads.

5. The implantable device of claim 4, wherein the metal-containing material is configured to form pores in the shell, before or after implanting or attaching the implantable device in or on a body of a human or an animal, when the beads are exposed to an external stimulus.

6. The implantable device of claim 4, wherein the metal-containing material comprises metallic particles.

7. The implantable device of claim 6, wherein the metallic particles comprise iron-containing particles, manganese-containing particles, an iron-containing polymer or a manganese-containing polymer.

8. The implantable device of claim 4, wherein the first and second materials comprise polymers.

9. The implantable device of claim 8, wherein the first material comprises poly lactic acid (PLA) or an iron-containing polymer and the second material comprises poly ε

-caprolactone (PCL).

10. The implantable device of claim 1, wherein the beads further contain a polymer.

11. The implantable device of claim 1, wherein the desired flow rate of elution of the drug is substantially constant.

12. The implantable device of claim 1, wherein the desired flow rate of elution of the drug is substantially constant for a first period of time and substantially zero for a second period of time, vice-versa, or any combinations thereof.

13. The implantable device of claim 1, wherein the desired flow rate of elution of the drug is increasing or decreasing with time, or any combinations thereof.

14. The implantable device of claim 1, further comprising a sensor configured to monitor a concentration of the drug in the body of the human or the animal.

15. The implantable device of claim 14, further comprising a side wall at or near a second end of the casing, wherein the casing is substantially tubular having at least the first end of the casing and the second end of the casing, and the second end of the casing is opposite the first end of the casing.

16. The implantable device of claim 15, further comprising a sonicator or a plate with holes therein, wherein the sonicator or the plate is located between the piston and the side wall.

17. The implantable device of claim 16, further comprising a first chamber between the semi-permeable plug and the piston, a second chamber between the piston and the sonicator or the plate, and a third chamber between the second chamber and the side wall, wherein the first chamber comprises a salt solution, the second chamber comprises the beads, and the third chamber comprises a foam.

18. The implantable device of claim 17, wherein the sonicator is configured to sonicate and increase porosity of the foam.

19. The implantable device of claim 18, wherein some or all of the holes in the plate are filled with a phase-change material.

20. The implantable device of claim 19, wherein the side wall contains the sensor.