Drug releasing pelvic treatment system and method

• US 10,272,235 B2
• Filed: 12/28/2015
• Issued: 04/30/2019
• 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.
• Primary Examiner(s): Gilbert, Andrew M
• Application Number:
  US14/981,128
• Publication Number:
  US 20160144161A1
• Time in Patent Office: 1,219 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. A system for delivering a therapeutic agent to a pelvic tissue comprising:

a delivery device configured to deliver tissue penetrating members to the pelvic tissue through a pelvic area passageway in a patient,

the delivery device including a lumen, a proximal end, a distal end, and an ejection member including a spring configured to contact at least one of the tissue penetrating members to force the tissue penetrating members from the distal end,

the tissue penetrating members being configured in a series that are disposed in the lumen in a proximal to distal arrangement, and configured to be deployed from the distal end of the delivery device and penetrate into the pelvic tissue, the tissue penetrating members including the therapeutic agent.

2. The system of claim 1, wherein the ejection member further includes at least one of a compressed air chamber, a hydraulic member, or a pneumatic pressure source.

3. The system of claim 1, wherein at least one of the tissue penetrating members has a length from a proximal end to a distal end in a 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.

4. The system of claim 1, wherein at least one of the tissue penetrating members has an average diameter in a range of about 150 μ

m to about 5 mm, about 500 μ

m to about 5 mm, or about 750 μ

m to about 3 mm.

5. The system of claim 1, wherein the delivery device is configured for insertion through at least one of a urethra, a vagina, an anus, or a uterus.

6. The system of claim 1, wherein at least one of the tissue penetrating members includes 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.

7. The system of claim 1, wherein at least one of the tissue penetrating members includes an elongated member, the elongated member includes a proximal end, a distal end, and a length between the proximal end and the distal end, the length being 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.

8. The system of claim 1, wherein at least one of the tissue penetrating members has an average diameter in a 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.

9. The system of claim 1, wherein at least one of the tissue penetrating members includes an elongated member, the elongated member includes a proximal end, a distal end, and a length between the proximal end and the distal end, the length being in a range of about 500 μ

m to about 1 centimeter.

10. The system of claim 1, wherein at least one of the tissue penetrating members has an average diameter in a range of about 150 μ

m to about 5 mm.

11. The system of claim 1, wherein at least one of the tissue penetrating members has a volume in a range of about 3000 μ

m³ to about 0.55 μ

m³, or about 0.01 μ

m³ to about 0.45 μ

m³, or about 0.05 μ

m³ to about 0.45 μ

m³.

12. The system of claim 1, wherein at least one of the tissue penetrating members has at least one of a dart, a barb, a spear, a spike, a lance, or an arrow point shape.

13. The system of claim 1, wherein at least one of the tissue penetrating members includes one or more projections on an elongate surface of the tissue penetrating members.

14. The system of claim 13, wherein the one or more projections are in a form of at least one of tines, barbs, or ridges.

15. The system of claim 1, wherein the tissue penetrating members include an absorbable polymeric material selected from at least one of polyhydroxyalkanoates, poly-4-hydroxybutyrate (P4HB), poly(3-hydroxyvalerate, and poly(hydroxybutyrate-co-hydroxyvalerate), polyesters, polylactic acid, poly(lactide-co-glycolide), polycaprolactone, poly(valerolactone), poly(glycolic acid), poly(glycolide), and poly(dioxanone);

polyorthoesters, polyalkeneanhydrides, poly(sebacic acid), polyanhydrides, polyphosphazines, polysaccharides, hyaluronic acid, alginate, dextran, starch, amylopectin, cellulose, xanthan, pullulan, chitosan, pectin, inulin, or heparin.

16. The system of claim 1, wherein the therapeutic agent comprises at least one of an antimuscarinic agent, oxybutynin, tolterodine, solifenacin, hyoscyamine, a nerve toxin, Botulinum toxin, chemotherapeutic agents, 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, taxol, rapamycin, tacrolimus, ABT-578, everolimus, paclitaxel, taxane, 13-cis retinoic acid, and 5-fluorouracil, a steroid, dexamethasone, cortisone, hydrocortisone, prednisone, prednisolone, triamcinolone methylprednisolone, beclomethasone, betamethasone, chloroprednisone, corticosterone, desoxycorticosterone, estradiol, fluorocortisone, androsterone, aldosterone, methyl testosterone, norethandrolone, estriol, estrone, hydroxyprogesterone, an antibiotic, amoxicillin, ephalexin, cefadroxil, cefuroxime, loracarbef, cefixime, pivmecillinam, trimethoprim-sulfamethoxazole, trimethoprim, ofloxacin, ciprofloxacin, norfloxacin, levofloxacin, doxycycline, tetracycline, minocycline, gentamicin, tobramycin, amikacin, nitrofurantoin, or azithromycin.

17. The system of claim 1, wherein the delivery device including a flexible catheter tube.

18. A method for delivering a therapeutic agent to a pelvic tissue comprising:

inserting a delivery device through a pelvic area passageway in a patient to deliver tissue penetrating members, the delivery device including a lumen, a proximal end, a distal end, and an ejection member including a spring configured to contact at least one of the tissue penetrating members to force the tissue penetrating members from the distal end, a series of tissue penetrating members disposed in the lumen in a proximal to distal arrangement, the tissue penetrating members configured to be deployed from the distal end of the deliver device and penetrate into the pelvic tissue, the tissue penetrating members including the therapeutic agent;

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

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

repeating the step of ejecting; and

releasing the therapeutic agent to the tissue from the tissue penetrating members.