IMPLANTABLE DEVICE WITH INTRAVESICAL TOLERABILITY AND METHODS OF TREATMENT

• US 20140221981A1
• Filed: 03/25/2014
• Published: 08/07/2014
• Est. Priority Date: 12/17/2009
• Status: Active Grant

• Current Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Original Assignee: Taris Biomedical LLC (Johnson & Johnson)
• Inventors: Cima, Michael J., Lee, Heejin
• Granted Patent: US 11,065,426 B2
• Time in Patent Office: Days
• US Class Current: 604/517
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 31/00 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 Class Codes: A61M 31/002 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 Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 23/02 Local anaesthetics

Abstract

Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient. The device may include an elastic body having a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters. The elastic body may exert a maximum acting force less than 1N when compressed to a shape with a maximum dimension in any dimension of 3 cm. The device may include a drug for controlled release within the bladder, for treatment of the bladder or a regional tissue. Methods of treatment are also provided that include selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern.

Claims

1. A drug delivery device for deployment within the bladder of a human patient which is well tolerated by the patient, comprising:

an elongated elastic body comprising a first end, an opposed second end, and an annular portion disposed between the first and second ends, wherein the elastic body comprises a drug reservoir lumen defined at least in part by the annular portion; and

a drug formulation loaded in the drug reservoir lumen, the drug formulation comprising a drug,

wherein the device has a retention shape having (i) dimensions that provide intravesical mobility and that prevent voiding of the medical device through the urethra, and (ii) dimensions, buoyancy, or both, that exclude the medical device from entering the orifices of the ureters.

2. The device of claim 1, wherein the retention shape has a maximum dimension in any dimension of 6 cm or less when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape having a maximum dimension of in any dimension of 3 cm.

3. The device of claim 2, wherein the device exerts a maximum acting force less than 1 N when the device is compressed from the retention shape to a shape with a maximum dimension in any dimension of 1.5 cm.

4. The device of claim 1, which is configured to provided controlled release of the drug by diffusion through a wall of the device body.

5. The device of claim 1, which is configured to provided controlled release of the drug through an aperture in the elastic body, driven at least in part by an osmotic pressure in the drug reservoir lumen.

6. The device of claim 1, wherein the device in the retention shape and uncompressed has a maximum dimension in any direction that is less than 10 cm.

7. The device of claim 1, wherein the device in the retention shape and uncompressed has a maximum dimension in any direction that is less than 5 cm.

8. The device of claim 1, wherein the elastic body is elastically deformable to take a low-profile shape having an outer diameter in one direction that is less than about 4 mm.

9. The device of claim 1, wherein the drug formulation is in a solid or semi-solid form.

10. The device of claim 1, wherein the drug formulation is in a liquid form.

11. The device of claim 1, wherein the retention shape is coiled.

12. The device of claim 1, further comprising a retention frame portion, which comprises an elastic wire.

13. The device of claim 1, wherein the elastic body comprises silicone, polyurethane, or a combination thereof.

14. A method of treatment of a human patient comprising:

selecting a patient in need of treatment in the bladder where tolerability of the treatment is a primary concern;

deploying the drug delivery device of claim 1 into the patient'"'"'s bladder through the patient'"'"'s urethra; and

controllably releasing the drug into the bladder from the deployed drug delivery device over a treatment period.

15. The method of claim 14, wherein the patient cannot feel the deployed device within his or her bladder during at least a majority of the treatment period.

16. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for overactive bladder, painful bladder syndrome, and/or interstitial cystitis.

17. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for an infection of the bladder, prostate, or urethra.

18. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for neurogenic bladder.

19. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for prostatitis or urethritis.

20. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for perioperative or postoperative pain associated with a urological surgery on the patient.

21. The method of claim 14, wherein the drug comprises lidocaine or another anesthetic agent.

22. The method of claim 14, wherein the selected patient is indicated to be in need of treatment for bladder cancer or prostate cancer.

23. The method of claim 14, wherein the drug is selected from the group consisting of antiproliferative agents, cytotoxic agents, chemotherapeutic agents, and combinations thereof.