Drug delivery devices and methods for controlled drug release through device orifice

Patent metadata

Field	Value
Publication number	US-10137287-B2
Application number	US-201414768291-A
Country	US
Kind code	B2
Filing date	Mar 5, 2014
Priority date	Mar 5, 2013
Publication date	Nov 27, 2018
Grant date	Nov 27, 2018

Abstract

A drug delivery device is provided. In an embodiment, the device includes a device body having an elongated drug reservoir lumen, a drug positioned in the drug reservoir lumen, and at least one end plug positioned at an end of the device body, for example inserted in an end of the drug reservoir lumen. The end plug may include an aperture therethough, and the drug delivery device may be configured to release the drug from the drug reservoir lumen through the aperture.

First claim

We claim:

1. An intravesical drug delivery device comprising:
a device body comprising an elongated drug reservoir lumen and a retention frame lumen;
a drug positioned in the drug reservoir lumen;
a retention frame which comprises an elastic wire; and
at least one end plug positioned at an end of the device body comprises an aperture through which the drug is released from the drug reservoir lumen,
wherein the aperture has an initial diameter which is configured to release the drug in vivo predominately driven by osmosis, and, after a period within the bladder, the aperture has a second diameter which is greater than the initial diameter and with which release of the drug in vivo is predominately driven by diffusion.

2. The device of claim 1 , wherein the aperture is defined by a bioerodible material.

3. The drug delivery device of claim 1 , wherein the device body is formed of silicone and the at least one end plug is positioned within an end of the drug reservoir lumen.

4. The drug delivery device of claim 1 , wherein the at least one end plug comprises poly (D, L-lactic-co-glycolic acid) (PLGA).

5. A drug delivery device for insertion into the bladder comprising:
a device body comprising an elongated drug reservoir lumen;
a drug positioned in the drug reservoir lumen; and
at least one end plug positioned at an end of the device body, the end plug comprising an aperture therethrough,
wherein the drug delivery device is configured to release the drug from the drug reservoir lumen through the aperture,
wherein the aperture is defined and directly bounded by a bioerodible material configured to degrade in vivo such that a diameter of the aperture increases over time in vivo and/or such that a length of the end plug defining the aperture decreases over time in vivo.

6. The drug delivery device of claim 5 , wherein the end plug is at least partially inserted into an end of the drug reservoir lumen.

7. The drug delivery device of claim 6 , wherein the end plug has an outer diameter that is slightly larger than an inner diameter of the drug reservoir lumen.

8. The drug delivery device of claim 6 , wherein the end plug has an outer diameter that is the same as or slightly smaller than an inner diameter of the drug reservoir lumen.

9. The drug delivery device of claim 6 , wherein the end plug is secured within the drug reservoir lumen by an adhesive.

10. The drug delivery device of claim 9 , wherein the end plug comprises a channel configured to receive the adhesive.

11. The drug delivery device of claim 6 , further comprising a clamp positioned about the drug reservoir lumen and configured to secure the end plug within the drug reservoir lumen.

12. The drug delivery device of claim 6 , wherein the end plug comprises one or more ribs disposed about an outer diameter of the end plug, the one or more ribs comprising a slightly larger outer diameter than an inner diameter of the drug reservoir lumen.

13. The drug delivery device of claim 5 , wherein the end plug comprises a cavity configured to receive an end portion of a retention frame.

14. The drug delivery device of claim 5 , wherein the bioerodible material comprises a biodegradable polymer.

15. A drug delivery device comprising:
a device body comprising an elongated drug reservoir lumen;
a drug positioned in the drug reservoir lumen; and
at least one end plug positioned at an end of the device body, the end plug comprising an aperture therethrough, the aperture having an opening extending through the at least one end plug and being in fluid communication with the drug reservoir lumen,
wherein the drug delivery device is configured to release the drug from the drug reservoir lumen through the aperture and the aperture is defined by a bioerodible material configured to degrade in vivo such that the opening of the aperture effective for drug release increases as the drug is released.

16. The device of claim 15 , wherein the at least one end plug comprises:
an outer body portion having a first end, a second end, and a sidewall extending between the first and second ends;
a core portion extending through the outer body portion between the first and second ends; and
the aperture extending through the core portion between the first and second ends,
wherein the core portion, or an annular element disposed between the core portion and the outer body portion, is formed of a bioerodible material,
wherein the aperture of the at least one end plug is configured to change in at least one of length and diameter as the core portion degrades.

17. The device of claim 16 , wherein the bioerodible material comprises PLA, PGA, PLGA, polyanhydrides, or another biodegradable polymer.

18. The device of claim 16 , wherein the outer body portion is formed of a non-bioerodible polymer.

19. A method of administering a drug to a patient, comprising:
inserting into the patient the drug delivery device of claim 15 ; and
permitting the drug to be released from the inserted device through the aperture.

20. The method of claim 19 , wherein the device is inserted into the patient's bladder.

21. The method of claim 20 , wherein the aperture has an initial diameter with which release of the drug in vivo is predominately driven by osmosis, and, after a period within the bladder, has a second diameter which is greater than the initial diameter and with which release of the drug in vivo is predominately driven by diffusion.

22. A drug delivery device comprising:
a device body comprising an elongated drug reservoir lumen;
a drug positioned in the drug reservoir lumen; and
an end plug positioned at an end of the device body, wherein the end plug comprises (i) an outer body portion having a first end, a second end, and a sidewall extending between the first and second ends; (ii) a core portion extending through the outer body portion between the first and second ends; and (iii) an aperture extending through the core portion between the first and second ends,
wherein the core portion, or an annular element disposed between the core portion and the outer body portion, is formed of a bioerodible material which defines the aperture, the bioerodible material being configured to degrade in vivo such that the aperture is configured to change in at least one of length and diameter as the core portion degrades, whereby an opening of the aperture effective for drug release increases as the drug is released from the drug reservoir lumen through the aperture, and
wherein the outer body portion is formed of a bioerodible polymer having a slower rate of degradation than the bioerodible material forming the core portion.

Assignees

• Taris Biomedical Llc

Inventors

• Sansone Matthew
• Daniel Karen
• Kim Grace
• Lee Heejin

Classifications

• A61K9/0024

  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 title

• A61M2205/0216

  Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking · CPC title

• A61M31/00

  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