DRUG RELEASING PELVIC TREATMENT SYSTEM AND METHOD

• US 20160144161A1
• Filed: 12/28/2015
• Published: 05/26/2016
• Est. Priority Date: 02/23/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Buysman, John Jason, Watschke, Brian P.
• Granted Patent: US 10,272,235 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2205/04 implanted
• 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: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54

Abstract

Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

Claims

1-24. -24. (canceled)

25. A system for delivering a therapeutic agent to a pelvic tissue comprising:

a delivery device configured for insertion through a pelvic area passageway in a patient and delivery of tissue penetrating members to a pelvic tissue;

the device comprising a lumen, a distal end, and an ejection member for forcing the tissue penetrating members from the distal end;

a series of tissue penetrating members loaded in the lumen in a proximal to distal arrangement, the tissue penetrating members configured for deployment from the distal end of the device and penetration into pelvic tissue, the tissue penetrating members comprising a therapeutic agent.

26. The system of claim 25 wherein the ejection member comprises a spring, a valve, a compressed air chamber, a hydraulic member, or a pneumatic pressure source.

27. The system of claim 25 wherein the tissue penetrating member has a length from it proximal to distal end in the range of about 500 μ

m to about 1 cm, about 1 mm to about 1 cm or about 2 mm to about 8 mm.

28. The system of claim 25 wherein the tissue penetrating member has an average diameter in the range of about 150 μ

m to about 5 mm, about 500 μ

m to about 5 mm, or about 750 to about 3 min.

30. The system of claim 25 wherein the delivery device is configured for insertion through a urethra, a vagina, an anus, or a uterus.

31. The system of claim 25 wherein the tissue penetrating member comprises an absorbable polymeric material and a therapeutic agent mixed with or surrounded by the polymeric material, the therapeutic agent releasable from the tissue penetrating member following implantation in tissue.

32. The system of claim 25 wherein the tissue penetrating member has an elongate shape and comprises a proximal end, a distal end, and a length between the proximal and the distal end in a range of about 50 μ

m to about 2000 μ

m, or about 100 μ

m to about 1500 μ

m, or about 200 μ

m to about 1000 μ

m, or about 250 μ

m to about 750 μ

m.

33. The system of claim 25 wherein the tissue penetrating member has an average diameter in the range of about 15 μ

m to about 1000 μ

m, or about 25 μ

m to about 750 μ

m, or about 50 μ

m to about 500 μ

m, or about 100 μ

m to about 250 μ

m.

34. The system of claim 25 wherein the tissue penetrating member has an elongate shape and comprises a proximal end, a distal end, and a length between the proximal and the distal end in a range of about 500 μ

m to about 1 centimeter.

35. The system of claim 25 wherein the tissue penetrating member has an average diameter in the range of about 150 μ

m to about 5 mm.

36. The system of claim 25 wherein the tissue penetrating member has a volume in the range of about 3000 μ

m³ to about 0.55 mm³, or about 0.01 mm³ to about 0.45 mm³, or about 0.05 mm³ to about 0.45 mm³.

37. The system of claim 25 wherein the tissue penetrating member has a dart, barb, spear, spike, lance, or arrow point shape.

38. The system of claim 25 wherein the tissue penetrating member comprises one or more projections on an elongate surface of the member.

39. The system of claim 25 wherein the projections are in the form of tines, barbs, or ridges.

40. The system of claim 25 wherein the absorbable polymeric material is selected from polyhydroxyalkanoates such as poly-4-hydroxybutyrate (P4HB), poly(3-hydroxyvalerate, and poly(hydroxybutyrate-co-hydroxyvalerate);

polyesters such as polylactic acid, poly(lactide-co-glycolide), polycaprolactone, poly(valerolactone), poly(glycolic acid), poly(glycolide), and poly(dioxanone);

polyorthoesters;

polyalkeneanhydrides such as, poly(sebacic acid);

polyanhydrides;

polyphosphazines; and

polysaccharides such as hyaluronic acid, alginate, dextran, starch, amylopectin, cellulose, xanthan, pullulan, chitosan, pectin, inulin, and heparin.

41. The system of claim 25 wherein the therapeutic agent comprises an antimuscarinic agent such as oxybutynin, tolterodine, solifenacin, and hyoscyamine;

a nerve toxin such as Botulinum toxin;

chemotherapeutic agents such as N,N′

,N′

-triethylenethiophosphoramide (ThioTEPA), adriamycin (doxorubicin, ADM), epirubicin (EPI), mitomycin C (MMC), valrubicin (AD32), pirarubicin (THP), gemcitabine, apaziquone (EOquin™

), and Vicinium™

(anti-Ep-CAM humanized scFv-exotoxin A fusion protein);

antiproliferative agents or angiogenesis inhibitors such as taxol, rapamycin, tacrolimus, ABT-578, everolimus, paclitaxel, taxane, 13-cis retinoic acid, and 5-fluorouracil;

a steroid such as dexamethasone, cortisone, hydrocortisone, prednisone, prednisolone, triamcinolone methylprednisolone, beclomethasone, betamethasone, chloroprednisone, corticosterone, desoxycorticosterone, estradiol, fluorocortisone, androsterone, aldosterone, methyl testosterone, norethandrolone, estriol, estrone, hydroxyprogesterone;

or an antibiotic such as amoxicillin, ephalexin, cefadroxil, cefuroxime, loracarbef, cefixime, pivmecillinam, trimethoprim-sulfamethoxazole, trimethoprim, ofloxacin, ciprofloxacin, norfloxacin, levofloxacin, doxycycline, tetracycline, minocycline, gentamicin, tobramycin, amikacin, nitrofurantoin, or azithromycin.

29. A method for delivering a therapeutic agent to a pelvic tissue comprising steps of:

providing a system comprising a delivery device configured for insertion through the a pelvic area passageway in a patient, the device comprising the device comprising a lumen, a distal end, and an ejection member for forcing the tissue penetrating members from the distal end, a series of tissue penetrating members loaded in the lumen in a proximal to distal arrangement, the tissue penetrating members configured for deployment from the distal end of the device and penetration into pelvic tissue, the tissue penetrating members comprising a therapeutic agent.

ejecting the tissue penetrating members from the distal end and into pelvic tissue;

moving the distal end the delivery device to a different tissue location;

repeating the step of ejecting; and

allowing therapeutic agent to be released from the tissue penetrating members.