Drug delivery devices and methods

Patent metadata

Field	Value
Publication number	US-10933170-B2
Application number	US-201515306792-A
Country	US
Kind code	B2
Filing date	May 12, 2015
Priority date	May 12, 2014
Publication date	Mar 2, 2021
Grant date	Mar 2, 2021

Abstract

Drug delivery devices are provided in which much of a drug payload within the device remains within an area proximal to a wall of the device through which the drug must pass for release of the drug from the device into a patient. In one case, the device may include a drug reservoir portion which has a drug reservoir lumen bounded by a reservoir wall having an inner surface; a drug located in the drug reservoir lumen; and a core region which does not comprise the drug, wherein the drug is disposed between the inner surface of the reservoir wall and the core region. The device may be elastically deformable between a first shape suited for insertion through a lumen into a body cavity of the patient and a second shape suited to retain the device within the body cavity.

First claim

We claim:

1. A drug delivery device for insertion into a patient's body, the drug delivery device comprising:
a drug reservoir portion which comprises a drug reservoir lumen bounded by a reservoir wall having an inner surface;
a drug formulation located in the drug reservoir lumen, wherein the drug formulation comprises a drug; and
a core region which does not comprise the drug, wherein the drug formulation is disposed between the inner surface of the reservoir wall and the core region,
wherein the drug delivery device is elastically deformable between a first shape suited for insertion through a lumen into a body cavity of the patient and a second shape suited to retain the drug delivery device within the body cavity, and
wherein the reservoir wall comprises an annular tube with opposed ends that are closed, wherein the annular tube is formed of a water-permeable elastomeric material.

2. The drug delivery device of claim 1 , wherein the core region comprises air, another gas, or a combination thereof.

3. The drug delivery device of claim 1 , wherein the drug formulation comprises a tablet and the core region comprises a hollow space within the tablet.

4. The drug delivery device of claim 1 , wherein the core region comprises a filler material or a structural object.

5. The drug delivery device of claim 4 , wherein the structural object is spherical, ellipsoidal, or substantially cylindrical.

6. The drug delivery device of claim 4 , wherein the structural object is threaded or helical.

7. The drug delivery device of claim 1 , wherein the core region comprises a structural object having an outer surface which conforms to the inner surface of the reservoir wall.

8. The drug delivery device of claim 1 , wherein the core region is affixed to the reservoir wall at one or more locations.

9. The drug delivery device of claim 8 , wherein the core region and the inner surface are integrally connected to one another along a continuous region extending from a first end of the drug reservoir lumen to a second, opposed end of the drug reservoir lumen.

10. The drug delivery device of claim 1 , wherein the water-permeable elastomeric material comprises silicone, polyurethane, or a combination thereof.

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

12. The drug delivery device of claim 1 , wherein the first shape is a relatively straightened shape suited for insertion through the patient's urethra and into the patient's bladder, and the second shape is a coiled retention shape suited to retain the drug delivery device wholly within the bladder.

13. The drug delivery device of claim 12 , further comprising a retention frame connected to the drug reservoir portion.

14. The drug delivery device of claim 1 , wherein:
the drug reservoir portion consists of (i) the reservoir wall which consists of the annular tube having the opposed ends that are closed, wherein the opposed ends are opposed first and second ends, the annulus of which is filled with the drug formulation and the core region, and (ii) sealing structures or adhesive sealing the opposed first and second ends of the annular tube,
the core region comprises one or more structural objects, and
the drug delivery device is configured to release the drug, following in vivo solubilization of the drug, by diffusion directly through and only through the reservoir wall.

15. The drug delivery device of claim 14 , wherein the drug formulation is annular shaped and the core region fills the annulus of the annular drug formulation.

16. The drug delivery device of claim 14 , further comprising an elastic wire retention frame, which is aligned with the annular tube of the drug reservoir portion.

17. A method of administering a drug to a patient in need thereof, comprising:
inserting into the patient the drug delivery device of claim 1 ; and then
permitting the drug to be released from the drug delivery device.

18. The method of claim 17 , wherein the drug delivery device is inserted into the patient's urinary bladder via through the patient's urethra.

19. An intravesical device for release of a drug into a patient's bladder, the intravesical device comprising:
a drug reservoir portion which comprises a lumen bounded by a reservoir wall having an interior portion which includes an inner surface;
a drug formulation, which comprises the drug, located in the interior portion of the reservoir wall; and
a core region in the lumen which does not comprise the drug,
wherein the intravesical device is elastically deformable between a first shape suited for insertion through a urethra of the patient into the bladder of the patient and a second shape suited to retain the intravesical device wholly within the bladder, and
wherein the reservoir wall comprises an annular tube with opposed ends that are closed.

20. The intravesical device of claim 19 , wherein the interior portion of the reservoir wall is in a form of a coating layer in which the drug formulation is dispersed.

21. The intravesical device of claim 19 , wherein the core region comprises air, another gas, or a combination thereof.

22. The intravesical device of claim 19 , wherein the annular tube is formed of a water-permeable elastomeric material.

23. The intravesical device of claim 19 , wherein:
the drug reservoir portion consists of (i) the reservoir wall which consists of the annular tube with the opposed ends that are closed, wherein the opposed ends are opposed first and second ends, the annulus of the annular tube being filled with the drug formulation and the core region, and (ii) sealing structures or adhesive sealing the first and second ends of the annular tube,
the core region comprises one or more structural objects, and
the intravesical device is configured to release the drug, following in vivo solubilization of the drug, by diffusion directly through and only through the reservoir wall.

24. The intravesical device of claim 23 , wherein the drug formulation is annular shaped and the core region fills the annulus of the annular drug formulation.

25. The intravesical device of claim 23 , further comprising an elastic wire retention frame, which is aligned with the annular tube of the drug reservoir portion.

26. The intravesical device of claim 19 , wherein the drug formulation comprises a plurality of tablets and the core region comprises a hollow space within each of the plurality of tablets.

27. The intravesical device of claim 19 , wherein the core region comprises a structural object having an outer surface which conforms to the inner surface of the reservoir wall.

28. The intravesical device of claim 19 , wherein the core region comprises one or more substantially cylindrical structural objects which are unattached to the reservoir wall.

Assignees

• Taris Biomedical Llc

Inventors

• Lee Heejin
• Daniel Karen
• Larrivee-Elkins Cheryl
• Agarwal Vikas
• Ho Duc Hong Linh

Classifications

• 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

• A61M2205/04

  implanted · CPC title

• 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

• A61K9/14

  Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} · CPC title

• A61K9/0034

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