Methods and devices for conduit occlusion

• US 8,316,854 B2
• Filed: 10/31/2011
• Issued: 11/27/2012
• Est. Priority Date: 02/25/2004
• Status: Active Grant

• Current Assignee: Femasys, Inc.
• Original Assignee: Femasys, Inc.
• Inventors: Lee-Sepsick, Kathy, Paxton, Lani L. L., Marcus, Jeffrey A., Williams, Stephen N.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US13/285,744
• Publication Number:
  US 20120042879A1
• Time in Patent Office: 393 Days
• Field of Search: None
• US Class Current: 128/831
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• 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 2017/1205 Introduction devices
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

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.

Claims

1. A method for occluding two fallopian tubes 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 two openings spaced from the atraumatic tip for providing two catheters;

two catheters, wherein each catheter comprises an end structure on a delivery end; and

means for providing an occlusive material composition into and through the two catheters;

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

c) positioning the delivery end of each of the catheters at or near a uterine cornua such that each of the end structures 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 each cathether 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 each fallopian tube.

2. The method of claim 1, wherein the 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 two fallopian tubes are fallopian tubes 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 4, wherein the cured composition swells less than 20%.

9. The method of claim 4, 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 9, wherein the occlusion is maintained by tissue ingrowth or wound healing or similar type response.

11. The method of claim 6, 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 11, wherein the composition comprises polymers.

14. The method of claim 11, wherein the composition is viewable by ultrasound.

15. The method of claim 4, 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.

16. The method of claim 11, 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.

17. 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 two openings spaced from the atraumatic tip for providing two catheters;

two catheters, wherein each catheter comprises an end structure on a delivery end; and

means for providing an occlusive material composition into and through the two catheters;

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

c) positioning the delivery end of each 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 an occlusive material composition at or near the tubal ostium such that the occlusive material material is provided to a portion of a lumen of each fallopian tube; and

e) occluding the two fallopian tubes by forming an occlusion with the occlusive material composition within the lumen of each fallopian tube.

18. 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;

attachment elements on a proximal end, and elements for providing the composition into and through the at least one catheter.

19. The device of claim 18, wherein the end structure is a cup, nozzle, or a balloon.

20. The device of claim 18, further comprising a delivery device stabilizer for holding the transcervical device in place once positioned.