METHODS AND DEVICES FOR CONTROLLED DELIVERY
Disclosed herein are exemplary medical devices for controlled delivery of material compositions, particularly occlusive, therapeutic, or diagnostic compositions. Medical devices disclosed herein comprise components for maintaining a stationary position, for providing catheters at a precise step in a method, for inflating or deflating a balloon, if present, and for providing a composition to a target site.
1 . A method for occluding at least one fallopian tube in a human or animal body, comprising,
a) providing a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing at least one catheter; at least one catheter, comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the one or more compositions; a handle; a system plunger controlled by a lock that is reversible coupled to a control rod, and a material cartridge containing the composition comprising an occlusive material positioned within a receptacle in the handle;
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 fallopian; 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 fallopian tubes are occluded without removal and re-introduction or substantial repositioning of the controlled delivery device.
3 . The method of claim 1 , wherein the composition comprising an occlusive material comprises a biodegradable cyanoacrylate composition.
4 . The method of claim 3 , wherein the composition, when cured, swells less than 20%.
5 . The method of claim 3 , wherein the composition is about 20% to about 100% substantially resorbed in a range of about 30 to about 365 days.
6 . The method of claim 1 , wherein the occlusion is maintained by tissue ingrowth.
7 . The method of claim 1 , 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.
8 . The method of claim 1 , 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.
9 . 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 device comprises at least an insertion tube for providing at least one catheter; at least one catheter, comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the one or more compositions; a handle; a system plunger controlled by a lock that is reversible coupled to a control rod, and a material cartridge containing the composition comprising an occlusive material positioned within a receptacle in the handle;
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.
10 . A contraceptive device, comprising at least an insertion tube for providing at least one catheter; at least one catheter, comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the one or more compositions; a handle; a system plunger controlled by a lock that is reversible coupled to a control rod, and a material cartridge containing the composition comprising an occlusive material positioned within a receptacle in the handle.
11 . The device of claim 10 , wherein the end structure is a cup, nozzle, or a balloon.