Methods and Devices for Conduit Occlusion

Abstract

The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of means for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable material that supports tissue ingrowth that eventually replaces the material leaving little or no original material in place. The delivery system is positioned to allow for placement of the occlusive material into the body conduit. Use of delivery systems, methods and devices for re-opening an occluded body conduit are also included.

What is claimed is: 
     
         1 . A method for occluding at least one conduit in a human or animal body, comprising,
 a) providing a delivery system capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery system comprises a delivery device comprising at least an introducer shaft for providing at least two catheters; two catheters, each comprising an end structure on a delivery end and attachment means on a proximal end, a composition comprising an occlusive material, and means for providing the composition comprising an occlusive material into and through the catheters;   b) delivering an effective amount of the composition comprising an occlusive material at or near the target site such that the material occludes the lumen of the conduit; and   c) occluding the conduit with the composition comprising an occlusive material within the lumen of the conduit.   
     
     
         2 . The method of  claim 1 , wherein two conduits are occluded without removal and re-introduction or substantial repositioning of the introducer shaft. 
     
     
         3 . The method of  claim 2 , wherein the two conduits are fallopian tubes of a mammal. 
     
     
         4 . The method of  claim 1 , further comprising, d) reopening the at least one conduit. 
     
     
         5 . The method of  claim 1 , wherein the composition comprising the occlusive material is mixed prior to delivery to the lumen. 
     
     
         6 . The method of  claim 1 , wherein the composition comprising an occlusive material comprises a liquid tissue adhesive and a solvated polymer, wherein the composition cures in situ. 
     
     
         7 . The method of  claim 1  wherein the composition comprising the occlusive material is ultrasound visible. 
     
     
         8 . The method of  claim 7 , wherein the ultrasound visible material comprises microbubbles of air or gas or microparticles of a material that entrap air or gas. 
     
     
         9 . The method of  claim 6 , wherein the liquid tissue adhesive is cyanoacrylate, polyacrylic acids, polyethylene glycols, modified polyethylene glycols, thrombin, collagen, collagen-based adhesives, fibrin, fibrin glue compositions, gelatin-resorcinol-formaldehyde-glutaraldehyde (GRFG) glue, autologous blood in combination with collagen or thrombin, crosslinked albumin adhesives, modified glycosaminiglycans, poly(N-isopropylacrylamide)-based adhesives, alginates, or chitosan or gelatin, crosslinked with carbodiimide or genepin; and the solvated polymer is a resorbable polyester, including polylactide, polyglycolide, or polycaprolactone or copolymers of these materials, including poly(lactide-/glycolide) acid (PLGA) or poly(lactide-co-F-caprolactone) (PLCL). 
     
     
         10 . The method of  claim 6 , wherein the cured composition swells less than 20%. 
     
     
         11 . The method of  claim 6 , wherein the cured composition is about 20% to about 100% substantially resorbed in a range of about 30 to about 365 days. 
     
     
         12 . The method of  claim 11 , wherein the occlusion is maintained by tissue ingrowth. 
     
     
         13 . The method of  claim 1 , wherein the composition comprising an occlusive material comprises a liquid tissue adhesive and particles. 
     
     
         14 . The method of  claim 13 , wherein the particles are nano- or micro-particles comprising spheres of resorbable polymers. 
     
     
         15 . The method of  claim 13 , wherein the particles are from about 0.1 micrometer to about 1000 micrometers in diameter. 
     
     
         16 . The method of  claim 1  wherein the occlusive material is viewable by ultrasound. 
     
     
         17 . The method of  claim 6 , wherein the composition further comprises tissue scarring agents, fibrosis agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof. 
     
     
         18 . The method of  claim 13 , wherein the composition further comprises a curable carrier for the occlusive materials, a control release agent, tissue scarring agents, fibrosis agents, fertilization inhibitors, contraceptive agents, tissue growth promoters, hormones, polymerization inhibitors, polymerization stabilizers, emulsifying agents, echogenic agents, contrast agents, viscosity-modifying materials, plasticizers, colorants or combinations thereof. 
     
     
         19 . A method for contraception, comprising,
 a) providing a delivery system capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery system comprises a delivery device comprising at least an introducer shaft for providing at least two catheters; two dual lumen balloon catheters; a composition comprising an occlusive material and means for providing the composition comprising an occlusive material into and through the catheters;   b) delivering an effective amount of the composition comprising an occlusive material at or near the target location such that the material occludes the lumen of at least one fallopian tube; and   c) occluding the fallopian tube with the composition comprising an occlusive material within the lumen of the conduit.   
     
     
         20 . A contraceptive device, comprising, an introducer shaft for providing at least two catheters; two catheters, each comprising an end structure at the delivery end; a composition comprising an occlusive material, and means for providing the composition comprising an occlusive material into and through the catheters. 
     
     
         21 . The device of  claim 19 , wherein the end structure is a cup, nozzle, or a balloon. 
     
     
         22 . The device of  claim 19 , further comprising a delivery device stabilizer for holding the contraceptive device in place once positioned. 
     
     
         23 . The device of  claim 21 , wherein the delivery device stabilizer fits over or attaches to the cervix or fits into or expands within the cervix to hold the device in position. 
     
     
         24 . A method for opening at least one occluded conduit, comprising,
 a) providing a delivery device comprising at least an introducer shaft for providing at least two catheters; two catheters, each comprising an end structure at the delivery end; and means for re-opening the conduit; and   b) re-opening the conduit.   
     
     
         25 . A method for opening at least one occluded conduit occluded by the method of  claim 1 , comprising
 a) providing a delivery system comprising a delivery device capable of delivering a means of opening the conduit; and   b) opening the conduit.   
     
     
         26 . The method of  claim 25 , wherein the delivery system capable of delivering means of opening the conduit comprises a delivery device comprising at least an introducer shaft for providing at least two catheters; at least one catheter, comprising a stationary device at one end; means for holding the delivery system in place upon positioning; and means for opening the conduit. 
     
     
         27 . The method of  claim 24 , wherein the means for opening the conduit comprise device or members for providing shockwaves to shatter the occluding material, chemical means including solvents, biological means including enzymes, or mechanical means including stiff or cutting catheter ends to recanalize the lumen. 
     
     
         28 . The method of  claim 24 , further comprising c) maintaining the opening of the conduit by providing a stent within the lumen of the conduit.