Methods and devices for conduit occlusion

• US 8,695,606 B2
• Filed: 11/24/2012
• Issued: 04/15/2014
• 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:
  US13/684,524
• Publication Number:
  US 20130220334A1
• Time in Patent Office: 507 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 contraceptive device, comprising,

an introducer shaft having a closed tip for contacting the fundus of a uterus and having at least one exit port spaced from the closed tip for providing at least one catheter;

and

at least one catheter, comprising at the delivery end, an end structure that aids in localized delivery of a composition to the tubal ostia of a fallopian tube, wherein the end structure is a cup, nozzle, or balloon.

2. The contraceptive device of claim 1, wherein the introducer shaft has one exit port and wherein the contraceptive device has one catheter.

3. The contraceptive device of claim 1, wherein the introducer shaft has two exit ports and wherein the contraceptive device has two catheters.

4. The contraceptive device of claim 1, further comprising means for providing the composition into and through the at least one catheter.

5. The contraceptive device of claim 1, further comprising a delivery device stabilizer for holding the contraceptive device in place once positioned therein a patient.

6. The contraceptive device of claim 5, wherein the delivery device stabilizer fits over or attaches to the cervix of the patient or fits into or expands within the cervix to hold the device in position.

7. The contraceptive device of claim 1, wherein the at least one catheter is a dual lumen balloon catheter.

8. The contraceptive device of claim 1, further comprising a composition comprising an occlusive material.

9. A delivery system for occluding one or two fallopian tubes in a mammal, comprising:

a delivery device comprising a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed tip, the introducer shaft defining one or two catheter channels along the interior length of the introducer shaft and defining one or two catheter channel openings proximate the tip of the introducer shaft, wherein the one or two catheter channels is configured for providing a catheter;

one or two catheters having a proximal end and an opposed delivery end comprising an end structure that maintains the delivery end in the uterine cornua and aids in localized delivery of a composition, wherein the one or two catheters is configured to be received therein the one or two catheter channels of the introducer shaft;

and means for providing a composition into and through the one or two catheters.

10. The contraceptive device of claim 9, wherein the introducer shaft has one catheter channel and wherein the delivery system has one catheter.

11. The contraceptive device of claim 9, wherein the introducer shaft has two catheter channels and wherein the delivery system has two catheters.

12. The delivery system of claim 9, wherein the one or two catheters is dual lumen balloon catheters.

13. The delivery system of claim 12, wherein the means for providing a composition into and through the one or two catheters comprises a first cartridge configured for operative connection to the proximal end of the one or two catheters, optionally, the first cartridge may contain a composition to be provided by the device.

14. The delivery system of claim 13, wherein the one or two catheters comprises a balloon proximate the delivery end, wherein a first lumen of the dual lumen catheter is in flow communication with the first cartridge when the first cartridge is operatively connected to the proximal end of the one or two catheters, and wherein a second lumen of the dual lumen catheter is in flow communication with the balloon.

15. The delivery system of claim 14, further comprising a second cartridge that contains a balloon distension media, wherein the second cartridge is configured for operative connection to the second lumen of the dual lumen catheter and is configured to selectively deliver the balloon distension media to the balloon therethrough the second lumen.

16. The delivery system of claim 9, wherein the end structure is a cup, nozzle, or balloon.

17. The delivery system of claim 9, further comprising a delivery device stabilizer positioned thereon the introducer shaft and configured to hold the delivery device in a selected position once the introducer shaft is inserted therein the mammal.

18. The delivery system of claim 17, wherein the delivery device stabilizer is configured to fit over, attach to, fit into, or expand within the cervix of the mammal to hold the delivery device in the selected position.

19. The delivery system of claim 9, further comprising a composition comprising an occlusive material.