Drug releasing pelvic treatment system and method
View Patent ↗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.
1. A system for delivering a therapeutic agent to a pelvic tissue comprising:
a delivery device configured for insertion through a pelvic passageway in a patient;
the delivery device comprising a distal end comprising an expandable elastic portion having a tissue-contacting expandable surface configured to come in contact with pelvic tissue;
tissue penetrating members projecting from the tissue-contacting surface of the expandable elastic portion, the tissue penetrating members configured for detachment from the expandable elastic portion after the members have penetrated the pelvic tissue; and
a therapeutic agent releasable from the tissue penetrating members,
wherein proximal ends of tissue penetrating members comprise absorbable material that fastens the tissue penetrating member proximal ends to the expandable surface and that erodes upon contact with liquid to release the tissue penetrating member from the expandable surface.
2. The system of claim 1 , wherein the delivery device is configured for insertion through a urethra, a vagina, or a uterus.
3. The system of claim 1 , wherein the expandable elastic portion having the tissue-contacting expandable surface is configured to come in contact with an inner surface of a bladder wall, an inner surface of a vaginal wall, or an inner surface of a uterine wall.
4. The system of claim 1 wherein the expandable elastic portion comprises an inflatable balloon.
5. The system of claim 1 wherein the tissue penetrating members have an elongate shape and comprises a proximal end and a distal end.
6. The system of claim 5 wherein the tissue penetrating members have a length from the proximal to distal end in the range of about 50 μm to about 2000 μm, or about 100 μm to about 1500 μm, or about 200 μm to about 1000 μm, or about 250 μm to about 750 μm.
7. The system of claim 5 wherein the tissue penetrating members have an average diameter in the range of about 15 μm to about 1000 μm, or about 25 μm to about 750 μm, or about 50 μm to about 500 μm, or about 100 μm to about 250 μm.
8. The system of claim 5 wherein the tissue penetrating members have a volume in the range of about 3000 μm 3 to about 0.55 mm 3 , or about 0.01 mm 3 to about 0.45 mm 3 , or about 0.05 mm 3 to about 0.45 mm 3 .
9. The system of claim 5 wherein the tissue penetrating members have a dart, barb, spear, spike, lance, or arrow point shape.
10. The system of claim 5 wherein the tissue penetrating members comprise one or more projections on an elongate surface of the members.
11. The system of claim 5 wherein the tissue penetrating members comprise a proximal portion that traverses material of the expandable elastic portion.
12. The system of claim 11 wherein proximal ends of the tissue penetrating members are located inside or at an inner surface of the expandable elastic portion, the proximal ends comprising the absorbable material, which fastens proximal ends of the tissue penetrating members to the expandable elastic portion.
13. The system of claim 12 comprising a liquid composition deliverable to the inside of the expandable elastic portion, wherein the liquid composition facilitates dissolution of the absorbable material.
14. The system of claim 1 wherein the tissue penetrating members comprise biodegradable polymeric material and a therapeutic agent mixed with or surrounded by the biodegradable polymeric material, the therapeutic agent releasable from the tissue penetrating member following implantation in tissue.
15. The system of claim 13 wherein the liquid composition is acidic.
16. The system of claim 1 wherein the absorbable material is selected from a non-crosslinked polysaccharide, a polyorthoester, and a poly(lactide-co-caprolactone) polymer.
17. The system of claim 14 wherein the biodegradable polymeric material is a polyhydroxyalkanoate.
18. The system of claim 17 wherein the polyhydroxyalkanoate is selected from the group consisting of: poly-4-hydroxybutyrate homopolymer, poly(3-hydroxyvalerate) homopolymer, and poly(hydroxybutyrate-co-hydroxyvalerate) copolymer.
19. The system of claim 1 wherein the therapeutic agent is a chemotherapeutic compound.
20. The system of claim 19 wherein the chemotherapeutic compound is selected from the group consisting of: N,N′,N′-triethylenethiophosphoramide, adriamycin, epirubicin, mitomycin C, valrubicin, pirarubicin, gemcitabine, apaziquone, and anti-Ep-CAM humanized scFv-exotoxin A fusion protein.
21. The system of claim 1 wherein the therapeutic agent is an antimuscarinic compound.
22. The system of claim 21 wherein the antimuscarinic compound is selected from the group consisting of oxybutynin, tolterodine, solifenacin, and hyoscyamine.
23. The system of claim 1 wherein the therapeutic agent is a nerve toxin.
24. The system of claim 21 wherein the nerve toxin is Botulinum toxin.
25. The system of claim 10 wherein the one or more projections prevent movement of the tissue penetrating member out of the pelvic tissue.
26. The system of claim 1 wherein the therapeutic agent is an antibiotic.
27. The system of claim 26 wherein the antibiotic is amoxicillin.