In vivo drug delivery devices and methods for drug delivery

Patent metadata

Field	Value
Publication number	US-11020575-B2
Application number	US-201816302061-A
Country	US
Kind code	B2
Filing date	Feb 1, 2018
Priority date	Feb 1, 2017
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

Drug delivery devices and methods of administering drugs to patients are provided. A device (50) includes a reservoir (60) containing a drug (58). The reservoir (60) is defined by a wall (64) having a water-permeable portion, such that the water-permeable portion permits water to enter the device (50) and contact the drug (58). A restraining plug (56) closes off an opening of the device (50) such that transient microchannels (62) form between an elastic portion (54) of the device (50) and the restraining plug (56), upon the generation of a sufficient pressure within the reservoir (60), to release the drug (58) from the device (50). Methods of treating patients for neurogenic detrusor overactivity resulting from a spinal cord injury and/or for idiopathic overactive bladder and urinary incontinence are also described.

First claim

What is claimed is:

1. A drug delivery device comprising:
a body that comprises a wall bounding a reservoir defined within the body, the wall having at least one preformed through-hole disposed in the wall and extending to the reservoir, and the wall comprising a water-permeable portion, the body comprising an elastic portion;
a drug formulation which comprises a drug, the drug formulation being disposed within the reservoir; and
at least one restraining plug, each of the at least one restraining plug closing off a respective opening of the body and contacting the elastic portion of the body, the respective opening being in fluid communication with the reservoir and with the at least one preformed through-hole,
wherein the water-permeable portion of the wall is configured to permit water to enter the drug delivery device and contact the drug formulation located in the reservoir,
wherein release of the drug from the device is controlled by (i) release of the drug through the at least one preformed through-hole in the wall, and (ii) release of the drug through the transient formation of one or more microchannels between the elastic portion of the body and the at least one restraining plug along an inner surface of the elastic portion of the body, extending to the respective opening, upon the generation within the reservoir of a hydrostatic pressure effective to form the one or more microchannels, and
wherein the one or more microchannels are configured to collapse at least partially as the hydrostatic pressure is relieved.

2. The drug delivery device of claim 1 , wherein release of the drug through the at least one preformed through-hole is osmotically driven.

3. The drug delivery device of claim 1 , wherein:
each of the at least one restraining plug has a respective outer diameter,
the elastic portion of the body defines at least one respective opening having a respective inner diameter, and
the respective outer diameter of each restraining plug exceeds the respective inner diameter of each respective opening of the elastic portion of the body by at least 3 percent.

4. The drug delivery device of claim 3 , wherein the respective outer diameter of each of the at least one restraining plug exceeds the respective inner diameter of the respective opening of the elastic portion of the body by at least 5 percent, at least 10 percent, at least 15 percent, at least 20 percent, or at least 25 percent.

5. The drug delivery device of claim 1 , wherein the body further comprises an inelastic portion.

6. The drug delivery device of claim 1 , wherein the at least one restraining plug is secured within the respective opening in the elastic portion of the body with an adhesive.

7. The drug delivery device of claim 1 , wherein the drug formulation is in a solid form.

8. The drug delivery device of claim 7 , wherein the device is configured to permit, in vivo, water to diffuse through the water-permeable portion of the wall and into the reservoir to solubilize the solid drug formulation.

9. The drug delivery device of claim 1 , wherein the drug comprises trospium or another antimuscarinic agent.

10. The drug delivery device of claim 1 , further comprising an osmotic agent.

11. The drug delivery device of claim 10 , wherein the osmotic agent is a component of the drug formulation.

12. The drug delivery device of claim 1 , wherein the at least one restraining plug is substantially cylindrical.

13. The drug delivery device of claim 1 , wherein the at least one restraining plug comprises a wedged, tapered, angled, or rounded surface.

14. The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is from about 40 A to about 60 A, and the Shore durometer of the at least one restraining plug is from about 70 A to about 100 A.

15. The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is from about 45 A to about 55 A, and the Shore durometer of the at least one restraining plug is from about 75 A to about 85 A.

16. The drug delivery device of claim 1 , wherein the Shore durometer of the elastic portion of the body is about 50 A, and the Shore durometer of the at least one restraining plug is about 80 A.

17. The drug delivery device of claim 1 , wherein the device is elastically deformable between a relatively straightened shape suitable for insertion through a lumen into a body cavity of a patient and a retention shape suited to retain the device within the body cavity.

18. The drug delivery device of claim 1 , wherein the body is formed from an elastomeric tube.

19. The drug delivery device of claim 1 , wherein the elastic portion of the body is formed from a water-permeable material.

20. The drug delivery device of claim 1 , wherein the at least one restraining plug has a parylene coating.

21. A drug delivery device comprising:
a tubular body that comprises a wall bounding a reservoir defined within the body, the wall comprising a water-permeable portion and an elastic portion having at least one preformed release port disposed in the elastic portion of the wall;
a drug formulation which comprises a drug, the drug formulation being disposed within the reservoir, wherein the water-permeable portion of the wall permits water to enter the drug delivery device and contact the drug formulation located in the reservoir; and
at least one restraining plug secured within the reservoir in contact with the elastic portion of the body and adjacent the at least one preformed release port, such that the at least one restraining plug controls release of the drug from the device, via the at least one preformed release port, by the transient formation of one or more microchannels between the elastic portion of the body and the at least one restraining plug along an inner surface of the elastic portion of the body, extending to the at least one preformed release port, upon the generation of a hydrostatic pressure within the reservoir effective to form the one or more microchannels, and
wherein the one or more microchannels are configured to collapse at least partially as the hydrostatic pressure is relieved, and
wherein the drug delivery device releases drug without degradation of the at least one restraining plug.

22. The drug delivery device of claim 21 , wherein the at least one preformed release port comprises a through-hole or a slit disposed in the wall.

23. The drug delivery device of claim 21 , wherein:
each of the at least one restraining plug has a respective outer diameter,
the elastic portion of the body defines at least one respective opening having a respective inner diameter, and
the respective outer diameter of each restraining plug exceeds the respective inner diameter of each respective opening of the elastic portion of the body by at least 3 percent.

24. The drug delivery device of claim 23 , wherein the respective outer diameter of each of the at least one restraining plug exceeds the respective inner diameter of the respective opening of the elastic portion of the body by at least 5 percent, at least 10 percent, at least 15 percent, at least 20 percent, or at least 25 percent.

25. The drug delivery device of claim 21 , wherein the body further comprises an inelastic portion.

26. The drug delivery device of claim 21 , wherein the at least one restraining plug is secured within the elastic portion of the body w

Assignees

• Taris Biomedical Llc

Inventors

• Lee Heejin
• Abbate Emily
• Hocking Sarah
• Giesing Dennis

Classifications

• A61M31/002 Primary

  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 title

• A61K9/0034

  Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants · CPC title

• A61M31/00 Primary

  Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) · CPC title

• A61M37/0069

  Devices for implanting pellets, e.g. markers or solid medicaments (for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027) · CPC title

• A61K9/0004

  Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas · CPC title