Methods and devices for conduit occlusion

• US 8,336,552 B2
• Filed: 10/31/2011
• Issued: 12/25/2012
• Est. Priority Date: 02/25/2004
• Status: Active Grant

• Current Assignee: Femasys, Inc.
• Original Assignee: Femasys, Inc.
• Inventors: Lee-Sepsick, Kathy, Azevedo, Max S., Currie, Daniel S.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US13/285,908
• Publication Number:
  US 20120042880A1
• Time in Patent Office: 421 Days
• Field of Search: None
• US Class Current: 128/831
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/4225 Cervix uteri
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 6/225 transcervical

Abstract

The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of elements for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable or degradable material that supports tissue ingrowth or wound healing or a similar response that replaces the cured occlusive material leaving little or no original occlusive 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.

Claims

1. A method for occluding at least one fallopian tube in a human or animal body, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, wherein the delivery system comprises a delivery device comprising an introducer shaft comprising an atraumatic tip and defining at least one opening spaced from the atraumatic tip for providing at least one catheter;

at least one catheter, wherein a catheter comprises an end structure on a delivery end; and

means for providing an occlusive material composition into and through the at least one catheter;

b) positioning the atraumatic tip of the introducer shaft at or near the fundus of a uterus;

c) positioning the delivery end of at least one catheter at or near a uterine cornua such that the end structure is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition;

d) delivering from a catheter an effective amount of an occlusive material composition at or near the ostia of the fallopian tubes; and

e) occluding the fallopian tubes by forming an occlusion with the occlusive material composition within the lumen of at least one fallopian tube.

2. The method of claim 1, wherein two fallopian tubes are occluded without removal and re-introduction, or substantial repositioning, of the introducer shaft.

3. The method of claim 2, wherein the fallopian tube is fallopian tube of a human.

4. The method of claim 1, wherein the occlusive material composition comprises a tissue adhesive.

5. The method of claim 1, wherein the occlusive material composition is ultrasound visible.

6. The method of claim 5, wherein the ultrasound visible material comprises microbubbles of air or gas or microparticles of a material that entrap air or gas.

7. The method of claim 4, wherein the tissue adhesive is cyanoacrylate, polyacrylic acids, polyethylene glycols, modified polyethylene glycols, thrombin, collagen, collagen-based adhesives, fibrin, fibrin glue compositions, gelatin-resorcinol-formaldehyde-glutaraldehye (GRFG) glue, autologous blood in combination with collagen or thrombin, crosslinked albumin adhesives, modified glycosaminoglycans, poly(N-isopropylacrylamide)-based adhesives, alginates, or chitosan or gelatin, crosslinked with carbodiimide or genepin or combinations thereof.

8. The method of claim 1, wherein occlusive composition material cures, and the cured composition swells less than 20%.

9. The method of claim 1, wherein the composition is about 20% to about 100% substantially resorbed or degraded in a range of about 30 to about 90 days.

10. The method of claim 1, wherein the occlusion is maintained by tissue ingrowth or wound healing or similar type response.

11. The method of claim 1, wherein the occlusive material composition further comprises polymers or particles.

12. The method of claim 11, wherein the particles are nano- or micro-particles.

13. The method of claim 1, wherein the composition comprises polymers.

14. The method of claim 1, wherein the composition further comprises tissue scarring agents, fibrosis agents, wound healing promoting 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.

15. The method of claim 1, wherein the composition further comprises a curable carrier for the occlusive materials, a control release agent, tissue scarring agents, wound healing promoting 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.

16. A method for contraception, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, wherein the delivery system comprises a delivery device comprising an introducer shaft comprising an atraumatic tip and defining at least one opening spaced from the atraumatic tip for providing at least one catheters;

at least one catheter, wherein a catheter comprises an end structure on a delivery end; and

means for providing an occlusive material composition into and through the at least one catheter;

b) positioning the atraumatic tip of the introducer shaft at or near the fundus of a uterus;

c) positioning the delivery end of at least one catheter at or near a uterine cornua such that the end structure is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition;

d) delivering an effective amount of the occlusive material composition at or near the tubal ostium such that the occlusive material is provided to a portion of a lumen of at least one fallopian tube; and

e) occluding at least one fallopian tubes by forming an occlusion with the occlusive material composition within the lumen of at least one fallopian tube.

17. A transcervical device, comprising, an introducer shaft comprising an atraumatic tip and defining at least one opening spaced from the atraumatic tip for providing at least one catheter;

at least one catheter comprising an end structure on a delivery end for maintaining the delivery end in the uterine cornua and aiding in localized delivery of a composition, and attachment elements on a proximal end.

18. The transcervical device of claim 17, further comprising elements for providing a composition into and through the at least one catheter and an ultrasound visible composition.

19. The device of claim 17, wherein the end structure is a cup, nozzle, or a balloon.

20. The device of claim 17, further comprising a delivery device stabilizer for holding the transcervical device in place once positioned.