IP Library › Granted Patent US 12,263,244
Granted Patent B2
US 12,263,244 · App. 17/470,541 · Granted Apr 1, 2025

Intravesical device for controlled drug delivery

Inventors: Heejin Lee (Bedford, MA); Michael J. Cima (Winchester, MA); Karen Daniel (Newton, MA); Cheryl Larrivee-Elkins (Framingham, MA)
Assignee: TARIS Biomedical LLC
A61K9/0092A61K9/0004A61K9/0034A61K31/167A61M31/002A61M2210/1085
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Quick Facts
Patent No.
US 12,263,244
App. No.
17/470,541
Granted
Apr 1, 2025
Kind
B2
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.

Claims (37)

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.

Assignments (4)
MERGER Recorded Jun 1, 2026
From: TARIS BIOMEDICAL LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 074806/0289 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2021
From: LEE, HEEJIN; CIMA, MICHAEL J; DANIEL, KAREN; LARRIVEE-ELKINS, CHERYL
To: TARIS BIOMEDICAL, INC.
Reel/Frame 058056/0883 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2021
From: LIRIS BIOMEDICAL, INC.
To: TARIS BIOMEDICAL LLC
Reel/Frame 058057/0133 →
CHANGE OF NAME Recorded Nov 9, 2021
From: TARIS BIOMEDICAL, INC.
To: LIRIS BIOMEDICAL, INC.
Reel/Frame 058336/0140 →
Continuity (6)
Continuation 15815843 · Nov 17, 2017
Continuation 14677182 · Apr 2, 2015
Division 12851494 · Aug 5, 2010
Continuation In Part 12825215 · Jun 28, 2010
Provisional Application 61241277 · Sep 10, 2009
Related Publication 20210401741A1 · Dec 30, 2021
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