Claims for Patent: 10,010,400

Summary for Patent: 10,010,400

Title:	Devices and methods for local delivery of drug to upper urinary tract
Abstract:	Drug delivery devices include a flexible elongate body having a bladder end portion, a kidney end portion, and a drug lumen extending therebetween; and a drug reservoir which is located at the bladder end portion, contains a drug, and is defined at least in part by a semi-permeable wall. Methods include inserting the device into the ureter of a patient and permitting water in the bladder to diffuse through the semi-permeable wall to create an osmotic pressure to pump the drug through the drug lumen and out of the device at the kidney end portion and into the renal pelvis.
Inventor(s):	Lee; Heejin (Bedford, MA), Larrivee-Elkins; Cheryl (Framingham, MA), Ho Duc; Hong Linh (Weston, MA), Mixter; Colin (Exeter, NH)
Assignee:	TARIS Biomedical LLC (Lexington, MA)
Application Number:	15/085,179
Patent Claims:	1. A method of administering a drug to a patient in need thereof, comprising: inserting a drug delivery device comprising a flexible elongate body having a bladder end portion, a kidney end portion, and a drug lumen extending between the bladder end portion and the kidney end portion, through the patient's urethra and bladder and into at least one of the patient's ureters, such that the bladder end portion of the device is located within the bladder of the patient and the kidney end portion of the device is located within a kidney of the patient, wherein the bladder end portion comprises a drug reservoir that is defined at least in part by a semi-permeable wall and contains a drug; and permitting water in the bladder to diffuse through the semi-permeable wall of the device to create an osmotic pressure within the drug reservoir to pump the drug from the bladder end portion through the drug lumen and out of the device through an opening at the kidney end portion of the device and into the renal pelvis. 2. The method of claim 1, wherein the drug is released into the renal pelvis continuously over a treatment period from one day to 90 days. 3. The method of claim 1, which does not include a step of manually filling the drug reservoir of the device with a liquid after the device is inserted into the patient. 4. The method of claim 1, wherein inserting the drug delivery device comprises positioning the drug delivery device within or adjacent a ureteral stent. 5. The method of claim 1, wherein the flexible elongate body is a ureteral stent and further comprises a drainage lumen extending between the bladder end portion and the kidney end portion. 6. The method of claim 1, wherein the drug delivery device is inserted following treating the patient with extracorporeal shock wave lithotripsy for treatment of kidney stones in the patient. 7. The method of claim 1, wherein the patient is in need of treatment or prophylaxis of a urinary tract infection or pyelonephritis. 8. The method of claim 7, wherein the drug comprises an antimicrobial agent. 9. The method of claim 7, wherein the drug comprises an aminoglycoside, a penem, or an iron mimetic. 10. The method of claim 7, wherein the drug comprises an antibiotic agent, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, a disinfectant agent, or an antiseptic agent. 11. The method of claim 7, wherein the drug is selected from the group consisting of trimethoprim/sulfamethoxazole, trimethoprim, ciprofloxacin, levofloxacin, norfloxacin, gatifloxacin, ofloxacin, nitrofurantoin, fosfomycin, pivmecillinam, cefpodoxime proxetil, ceftibuten, cefotaxime, ceftriaxone, ceftazidime, cefepime, amoxicillin/clavulanic acid, piperacillin/tazobactam, gentamicin, amikacin, ertapenem, imipenem/cilastatin, meropenem, doripenem, aztreonam, a gallium-based iron mimetic, and combinations thereof. 12. The method of claim 7, wherein the drug comprises attenuated bacteria/pathogen for colonizing the genitourinary tract with non-pathogenic bacteria to prevent recurrent urinary tract infection or pyelonephritis. 13. The method of claim 1, wherein the patient is in need of treatment of renal cell carcinoma. 14. The method of claim 13, wherein the drug is selected from the group consisting of everolimus, aldesleukin, bevacizumab, axitinib, sorafenib tosylate, pazopanib hydrochloride, aldesleukin, sunitnib malate, temsirolimus, and combinations thereof. 15. The method of claim 1, wherein the patient is in need of treatment of upper tract urothelial carcinoma. 16. The method of claim 15, wherein the drug is selected from the group consisting of Bacillus Calmette-Guerin (BCG), Mitomycin C, BCG/interferon, interferon-2a, epirubicin, doxorubicin, thiotepa, gemcitabine, and combinations thereof. 17. The method of claim 1, wherein the patient is in need of treatment of hyperfibrinolysis. 18. The method of claim 17, wherein the drug is selected from the group consisting of tranexamic acid, aminocaproic acid, and combinations thereof. 19. The method of claim 1, wherein the patient is in need of treatment of urinary stones. 20. The method of claim 19, wherein the drug is selected from the group consisting of antimicrobials, alkalinizing agents, acidification agents, urease inhibitors, and combinations thereof. 21. The method of claim 1, wherein the drug comprises an anti-inflammatory agent or an antifibrotic agent. 22. A method of administering a drug to a patient in need thereof, comprising: inserting a drug delivery device comprising a flexible elongate body having a bladder end portion, a kidney end portion, and a drug lumen extending between the bladder end portion and the kidney end portion, through the patient's urethra and bladder and into at least one of the patient's ureters, such that the bladder end portion of the device is located within the bladder of the patient and the kidney end portion of the device is located within a kidney of the patient, wherein the bladder end portion comprises a drug reservoir, which is separate from and in fluid communication with the drug lumen, and that is defined at least in part by a semi-permeable wall and contains a drug; and permitting water in the bladder to diffuse through the semi-permeable wall of the device to create an osmotic pressure to pump the drug from the bladder end portion through the drug lumen and out of the device through an opening at the kidney end portion of the device and into the renal pelvis. 23. The method of claim 22, wherein the drug is released into the renal pelvis continuously over a treatment period from one day to 90 days. 24. The method of claim 22, which does not include a step of manually filling the drug reservoir of the device with a liquid after the device is inserted into the patient. 25. The method of claim 22, wherein inserting the drug delivery device comprises positioning the drug delivery device within or adjacent a ureteral stent. 26. The method of claim 22, wherein the flexible elongate body is a ureteral stent and further comprises a drainage lumen extending between the bladder end portion and the kidney end portion. 27. The method of claim 22, wherein the drug comprises an anti-inflammatory agent or an antifibrotic agent. 28. The method of claim 22, wherein the drug delivery device is inserted following treating the patient with extracorporeal shock wave lithotripsy for treatment of kidney stones in the patient. 29. The method of claim 22, wherein the patient is in need of treatment or prophylaxis of a urinary tract infection or pyelonephritis. 30. The method of claim 22, wherein the patient is in need of treatment of renal cell carcinoma or upper tract urothelial carcinoma.

Details for Patent 10,010,400

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2035-03-30
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992		2035-03-30
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2035-03-30