Implantable Device with Intravesical Tolerability and Methods of Treatment

• US 20110152839A1
• Filed: 12/17/2010
• Published: 06/23/2011
• 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 8,679,094 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 1 N 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 medical device which is wholly deployable within the bladder of a human patient and well tolerated by the patient, comprising:

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.

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

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

4. 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.

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

6. The device of claim 1, wherein the device in the retention shape is dimensioned to exclude the device from fitting through an opening having the shape of an isosceles triangle having two sides 2.8 cm long and one side 3.3 cm long.

7. 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.

8. The device of claim 1, wherein the device in a dry state has a density less than 1.5 g/mL.

9. The device of claim 1, wherein the device in a dry state has a density from 0.5 g/mL to 1.3 g/mL.

10. The device of claim 1, wherein the elastic body houses or comprises at least one drug for controlled release within the bladder.

11. The device of claim 10, wherein the elastic body houses a drug formulation which is in the form of a plurality of compressed tablets which comprises the at least one drug.

12. A drug delivery device which is wholly deployable within the bladder of a human patient and well tolerated by the patient, comprising:

an elastic body housing a solid drug formulation,

wherein the device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 5 cm when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the retention shape is compressed to a shape having a maximum dimension in any dimension of 3 cm.

13. 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 a drug delivery device into the patient'"'"'s bladder through the patient'"'"'s urethra; and

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

14. The method of claim 13, wherein the patient cannot feel the deployed device within his or her bladder during at least a majority of the treatment period.

15. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for overactive bladder.

16. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for painful bladder syndrome.

17. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for interstitial cystitis.

18. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for an infection of the bladder, prostate, or urethra.

19. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for neurogenic bladder.

20. The method of claim 13, wherein the selected patient is indicated to be in need of treatment for prostatitis or urethritis.

21. The method of claim 13, 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.

22. The method of claim 13, wherein the drug delivery device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 5 cm when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the retention shape is compressed to a shape having a maximum dimension in any dimension of 3 cm.

23. The method of claim 13, wherein the drug comprises lidocaine or another anesthetic agent.

25. The method of claim 23, wherein the at least one genitourinary tissue sites is selected from the group consisting of urethra, ureter, kidneys, penis, testes, prostate, seminal vesicles, ejaculatory ducts, vas deferens, vagina, uterus, ovaries, fallopian tubes, and combinations thereof

26. The method of claim 23, further comprising selecting a patient in need of treatment where tolerability of the drug delivery device to be deployed in the bladder is a primary concern.

27. The method of claim 23, wherein the drug delivery device comprising a drug delivery portion and a retention frame portion, the drug delivery portion housing a solid drug formulation comprising the drug, the retention frame portion configured for retaining the device in the bladder.

28. The method of claim 23, wherein the drug delivery device is deformable between a deployment shape for passage of the device through the urethra and a retention shape for preventing voiding of the device through the urethra, the retention shape having a maximum dimension in any dimension of 5 cm when in an uncompressed state and wherein the device exerts a maximum acting force less than 1 N when the retention shape is compressed to a shape having a maximum dimension in any dimension of 3 cm.

29. The method of claim 23, wherein the drug comprises lidocaine or another anesthetic agent.

30. The method of claim 23, 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.

24. A method of treating a genitourinary tissue site in a patient, the method comprising:

deploying a drug delivery device into the bladder of the patient; and

releasing a drug from the drug delivery device into the bladder in an amount and at a rate to administer a therapeutically effective amount of the drug to at least one genitourinary tissue site other than the bladder.