Intravesical device for controlled drug delivery

Patent metadata

Field	Value
Publication number	US-12263244-B2
Application number	US-202117470541-A
Country	US
Kind code	B2
Filing date	Sep 9, 2021
Priority date	Sep 10, 2009
Publication date	Apr 1, 2025
Grant date	Apr 1, 2025

Abstract

Implantable devices and methods for delivery of lidocaine or other drugs to a patient are provided. In one embodiment, the device includes a first drug portion which has a first drug housing which contains a first drug formulation in a solid form which includes a pharmaceutically acceptable salt of lidocaine; and a second drug portion which includes a second drug housing which contains a second drug formulation which includes lidocaine base. In another embodiment, the device includes a drug reservoir component which has an elastic tube having at least one lumen bounded by a porous sidewall having an open-cell structure, a closed-cell structure, or a combination thereof; and a drug formulation contained within the at least one lumen, wherein the device is deformable between a low-profile deployment shape and a relatively expanded retention shape.

First claim

We claim:

1. An intravesical device for drug delivery to the urinary bladder of a patient, comprising:
a tubular device body which comprises a drug reservoir lumen and a retention frame lumen;
a drug formulation comprising a plurality of aligned solid drug units, which comprise a drug, disposed in the drug reservoir lumen; and
a nitinol retention frame disposed in the retention frame lumen,
wherein the device has no drug release aperture and releases the drug by trans-wall diffusion; and
wherein the solid drug units are tablets each of which has a cylindrical side face and a length:width aspect ratio greater than 1:1.

2. The device of claim 1 , wherein the device body comprises two integrally formed annular tubes that are aligned and adjoined along a longitudinal edge.

3. The device of claim 1 , wherein the tubular device body is elastically deformable and comprises two or more curls that turn in alternating directions and that do not overlap.

4. The device of claim 3 , wherein the two or more curls are connected linearly.

5. The device of claim 1 , wherein the tubular device body is elastically deformable and comprises overlapping curls.

6. The device of claim 1 , wherein the tubular device body is elastically deformable and has exactly two opposing ends, which are directed away from one another when the device is in a low-profile deployment shape.

7. The device of claim 6 , wherein the two opposing ends are directed toward one another when the device is a relatively expanded retention shape.

8. The device of claim 1 , wherein the drug comprises an antiproliferative agent, a cytotoxic agent, or a chemotherapeutic agent.

9. The device of claim 1 , wherein:
the device body (i) comprises two integrally formed tubes that are aligned and adjoined along a longitudinal edge, (ii) is elastically deformable and comprises overlapping curls, and (iii) has exactly two opposing ends, which are directed away from one another when the device is in a low-profile deployment shape and which are directed toward one another when the device is a relatively expanded retention shape.

10. The device of claim 1 , wherein each of the tablets has flat end faces at opposed ends of the cylindrical side face.

11. The device of claim 1 , wherein the drug comprises an FGFR3-selective tyrosine kinase inhibitor.

12. An intravesical device for drug delivery to the urinary bladder of a patient, comprising:
a tubular device body which comprises a drug reservoir lumen and a retention frame lumen;
a first drug formulation comprising a first plurality of aligned solid drug units, which comprise a first drug, disposed in the drug reservoir lumen;
a second drug formulation comprising a second plurality of aligned solid drug units, which comprises a second drug; and
an elastic retention frame disposed in the retention frame lumen,
wherein the device is configured to release the first drug according to a first release profile and to release the second drug according to a second release profile,
wherein the first and second release profile and/or the first and second drugs are different from one another, and
wherein the solid drug units are tablets each of which has a cylindrical side face and a length:width aspect ratio greater than 1:1.

13. The device of claim 12 , wherein the first and second drug formulations differ from each other with reference to active ingredient content or excipient content.

14. The device of claim 12 , wherein the second drug formulation is disposed in the drug reservoir lumen.

15. The device of claim 14 , further comprising a partition structure between the first and second drug formulations.

16. The device of claim 12 , wherein the device body comprises two integrally formed annular tubes that are aligned and adjoined along a longitudinal edge.

17. The device of claim 12 , wherein the tubular device body is elastically deformable and comprises overlapping curls.

18. The device of claim 12 , wherein the tubular device body is elastically deformable and comprises two or more curls that turn in alternating directions and that do not overlap.

19. The device of claim 18 , wherein the two or more curls are connected linearly.

20. The device of claim 12 , wherein the tubular device body is elastically deformable and has exactly two opposing ends, which are directed away from one another when the device is in a low-profile deployment shape.

21. The device of claim 20 , wherein the two opposing ends are directed toward one another when the device is a relatively expanded retention shape.

22. The device of claim 12 , wherein the drug comprises an antiproliferative agent, a cytotoxic agent, or a chemotherapeutic agent.

23. The device of claim 12 , wherein each of the tablets has flat end faces at opposed ends of the cylindrical side face.

24. The device of claim 12 , wherein the first drug comprises an FGFR3-selective tyrosine kinase inhibitor.

Assignees

• Taris Biomedical Llc

Inventors

• Lee Heejin
• Cima Michael J
• Daniel Karen
• Larrivee-Elkins Cheryl

Classifications

• A61K9/0004

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

• A61M31/002

  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 title

• A61M2210/1085

  Bladder · CPC title

• A61K31/167

  having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol · CPC title

• A61K9/0034

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