Methods and devices for conduit occlusion

• US 8,048,086 B2
• Filed: 02/24/2005
• Issued: 11/01/2011
• Est. Priority Date: 02/25/2004
• Status: Active Grant

• Current Assignee: Femasys, Inc.
• Original Assignee: Femasys, Inc.
• Inventors: Williams, Stephen N., Paxton, Lani L. L., Marcus, Jeffrey A., Lee-Sepsick, Kathy
• Primary Examiner(s): Wax; Robert A
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US11/065,886
• Publication Number:
  US 20050187561A1
• Time in Patent Office: 2,441 Days
• Field of Search: None
• US Class Current: 606/108
• 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 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 the delivery system comprising a delivery device comprising an introducer shaft comprising a closed tip and defining at least one opening spaced from the closed tip for providing at least one catheter;

at least one catheter comprising an end structure on a delivery end an occlusive material composition and means for providing the occlusive material composition into and through at least one catheter;

b) positioning the closed 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 at least one 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 the catheter to at least one tubal ostium and a portion of its fallopian tube an effective amount of the occlusive material composition to effect occlusion of at least one fallopian tube.

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

3. The method of claim 1, further comprising, e) reopening at least one fallopian tube.

4. The method of claim 1, wherein the occlusive material composition is mixed prior to delivery to the lumen.

5. The method of claim 1, wherein the occlusive material composition cures in situ to form a cured composition.

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

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

8. The method of claim 1, wherein the occlusive material composition comprises 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 glycosaminiglycans, poly(N-isopropylacrylamide)-based adhesives, alginates, or chitosan or gelatin, crosslinked with carbodiimide or genepin;

a resorbable polyester of polylactide, polyglycolide, or polycaprolactone or copolymers of these materials, including poly(lactide-/glycolide) acid (PLGA) or poly(lactide-co-ε

-caprolactone) (PLCL).

9. The method of claim 5, wherein the cured composition swells less than 20%.

10. The method of claim 5, wherein the cured composition is about 20% to about 100% substantially resorbed in a range of about 30 to about 365 days.

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

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

13. The method of claim 11, wherein the particles are from about 0.1 micrometer to about 1000 micrometers in diameter.

14. The method of claim 8, wherein the occlusive material 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.

15. The method of claim 8, wherein the occlusive material_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.

24. The method of claim 1, wherein the at least one opening comprises two openings, and wherein the at least one catheter comprises two catheters.

25. The method of claim 24, wherein each of the two openings provides a respective catheter of the two catheters.

26. The method of claim 1, wherein positioning the delivery end of at least one catheter comprises

c1) positioning the delivery ends of two catheters, each respectively at or near a uterine cornua such that each catheter end structure is near a tubal ostium;

and

d1) delivering from each catheter an effective amount of the occlusive material composition to effect occlusion of two fallopian tubes.

27. The method of claim 1, wherein the end structure is a nozzle, cup or balloon.

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 with a closed tip that provides at least one catheter;

at least one dual lumen balloon catheter comprising a balloon end structure on a delivery end;

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

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

d) delivering from the catheter to at least one tubal ostium and a portion of its fallopian tube an effective amount of the occlusive material composition; and

e) occluding the fallopian tube.

17. A method for occluding at least one fallopian tube in a mammal, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining at least one catheter channel along the interior length of the introducer shaft and defining at least one respective catheter channel opening spaced proximally from the closed tip of the introducer shaft, wherein the at least one catheter channel is configured for providing a respective catheter;

at least one catheter having a delivery end, wherein at least one catheter is configured to be received therein the at least one catheter channel of the introducer shaft;

an occlusive material composition; and

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

b) inserting the introducer shaft therethrough a cervix of the mammal until the closed tip contacts a uterine fundus of the mammal, and at least one catheter channel opening is directed toward a uterine cornua of the mammal;

c) moving at least one catheter therethrough at least one catheter channel until the delivery end of the catheter exits the catheter channel opening and the delivery end of at least one catheter is located within at least one uterine cornua and 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; and

d) delivering an effective amount of the occlusive material composition through and out the delivery end of at least one catheter so that a fallopian tube is occluded.

18. The method of claim 17, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.

19. The method of claim 17, further comprising,

e) withdrawing at least one catheter therein the introducer shaft;

and

f) withdrawing the introducer shaft from the cervix of the mammal, thereby removing the delivery system from the mammal.

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

20. A method for delivering a fluid composition to at least one fallopian tube in a mammal, comprising,

a) providing a delivery system that delivers an effective amount of a fluid composition the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining at least one catheter channel along the interior length of the introducer shaft and defining at least one respective catheter channel opening spaced proximally from the closed tip of the introducer shaft, wherein at least one catheter channel is configured for providing a respective catheter;

at least one dual lumen balloon catheter having a delivery end and an end structure, wherein at least one catheter is configured to be received therein at least one a respective catheter channel of the introducer shaft;

a fluid composition; and

means for providing the fluid composition into and through the at least one catheter;

b) inserting the introducer shaft therethrough a cervix of the mammal until the closed tip contacts a uterine fundus of the mammal, wherein when the closed tip contacts the uterine fundus, at least one catheter channel opening is directed toward a uterine cornua of the mammal;

c) moving at least one catheter therethrough at least one catheter channel until the delivery end of at least one catheter exits the catheter channel opening and the delivery end of at least one catheter is located at or near at least one uterine cornua, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the fluid composition;

d) delivering from at least one catheter to at least one tubal ostium and a portion of its fallopian tube an effective amount of the fluid composition.

21. The method of claim 20, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.

29. The method of claim 20, wherein the end structure is a nozzle, cup or balloon.

22. A method for contraception of a mammal, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining at least one catheter channel along the interior length of the introducer shaft and defining at least one respective catheter channel opening spaced proximally from the closed tip of the introducer shaft, wherein at least one catheter channel is configured for providing a catheter;

at least one catheter having a delivery end and an end structure, wherein at least one catheter is configured to be received therein at least one catheter channel of the introducer shaft;

an occlusive material composition; and

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

b) inserting the introducer shaft therethrough a cervix of a mammal until the closed tip contacts a uterine fundus of the mammal, wherein when the closed tip contacts the uterine fundus, at least one catheter channel opening is directed toward a uterine cornua of the mammal;

c) moving at least one catheter therethrough at least one catheter channel until the delivery end of at least one catheter exits the catheter channel opening and the delivery end of the at least one catheter is located at or near at least one uterine cornua and 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 the catheter to at least one tubal ostium and a portion of its fallopian tube an effective amount of the occlusive material composition; and

e) occluding at least one fallopian tube.

23. The method of claim 22, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.

30. The method of claim 22, wherein the end structure is a nozzle, cup or balloon.