METHODS AND DEVICES FOR DETERMINING LUMEN OCCLUSION

• US 20110137150A1
• Filed: 06/20/2006
• Published: 06/09/2011
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Connor, Viviane, Sinclair, Edward, Swann, Betsy
• Granted Patent: US 8,123,693 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61F 6/20 Vas deferens occluders; Fallopian occluders
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491

Abstract

Embodiments of the present invention describe methods of determining the occlusion of body lumens and apparatuses for doing so. In one particular embodiment, the occlusion of the fallopian tubes by an intrafallopian contraceptive device may be confirmed by contrast enhanced ultrasonography (also known as stimulated acoustic emission hysterosalpingo-contrast sonography). In these embodiments a contrast agent containing microbubbles is used.

Claims

1. A method, comprising:

administering an echogenic contrast agent containing microbubbles to a body lumen using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent containing microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent containing microbubbles and the saline at a point of use;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the body lumen by monitoring the pressure; and

determining occlusion of the body lumen with contrast enhanced ultrasonography.

2. A method, comprising:

administrating an echogenic contrast agent that includes microbubbles to a fallopian tube using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent that includes microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent that includes microbubbles and the saline at a point of use;

placing an intrafallopian contraceptive device within the fallopian tube;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the fallopian tube by monitoring the pressure; and

confirming placement of the contraceptive device with contrast enhanced ultrasonography.

3. The method of claim 2, further comprising confirming occlusion of the fallopian tube at a future date.

4. The method of claim 3, wherein the future date is approximately three months from placement of the intrafallopian contraceptive device within the fallopian tube.

5. The method of claim 2, further comprising determining whether the fallopian tube is occluded prior to placing the intrafallopian contraceptive device within the fallopian tube.

6. The method of claim 2, further comprising mixing the echogenic contrast agent that includes microbubbles with the saline at the point of use prior to administering the echogenic contrast agent.

7. The method of claim 2, wherein the echogenic contrast agent comprises saline and carbon dioxide microbubbles.

8. The method of claim 2, wherein the syringe further comprises a plunger.

9. The method of claim 2, wherein administrating an echogenic contrast agent that includes microbubbles to the fallopian tube occurs before placing an intrafallopian contraceptive device within the fallopian tube.

10. The method of claim 2, wherein administrating an echogenic contrast agent that includes microbubbles to the fallopian tube occurs after placing an intrafallopian contraceptive device within the fallopian tube.

11. A method, comprising:

administrating an echogenic contrast agent that includes microbubbles to a uterus and fallopian tubes using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent that includes microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent that includes microbubbles and the saline at a point of use;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the uterus and fallopian tubes by monitoring the pressure; and

verifying with contrast enhanced ultrasonography proper placement of a contraception device which occludes one of the fallopian tubes.

12. A method, comprising:

administrating an echogenic contrast agent that includes microbubbles to a uterus and fallopian tubes using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent that includes microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent that includes microbubbles and the saline at a point of use;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the uterus and fallopian tubes by monitoring the pressure;

verifying proper placement of a contraception device within the fallopian tubes with contrast enhanced ultrasonography; and

verifying tubal occlusion of the fallopian tubes with contrast enhanced ultrasonography after verifying proper placement of the contraception device within the fallopian tubes.

13. A method, comprising:

administrating an echogenic contrast agent that includes microbubbles to a uterus and fallopian tubes using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent that includes microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent that includes microbubbles and the saline at a point of use;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the uterus and fallopian tubes by monitoring the pressure; and

determining tubal occlusion of the fallopian tubes with contrast enhanced ultrasonography.

14. A method of claim 13 wherein the tubal occlusion occurs at least in part through tissue in-growth into fallopian tube contraception devices implanted within each of the fallopian tubes.

15. The method of claim 13, wherein the pressure gauge is coupled to the static mixer.

16. The method of claim 13, wherein the pressure gauge is coupled to the static mixer at a tip of the syringe.

17. A method, comprising:

administrating an echogenic contrast agent that includes microbubbles to a uterus and a pair of fallopian tubes containing intrafallopian contraceptive devices using a syringe coupled to a pressure gauge, wherein the syringe coupled to the pressure gauge further comprises a first barrel containing the echogenic contrast agent that includes microbubbles, a second barrel containing saline, and a static mixer coupled to the first and second barrels that mixes the echogenic contrast agent that includes microbubbles and the saline at a point of use;

measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the pressure gauge;

determining distention of the uterus and fallopian tubes by monitoring the pressure; and

confirming occlusion of the fallopian tubes with contrast enhanced ultrasonography.

18. A kit, comprising:

an intrafallopian contraceptive device;

an echogenic contrast agent that includes microbubbles; and

a dual barrel syringe having a first barrel, a second barrel, and a plunger, wherein the echogenic contrast agent that includes microbubbles is contained in the first barrel, saline is contained in the second barrel, a static mixer coupled to the first and second barrels to mix the echogenic contrast agent that includes microbubbles and the saline at a point of use, and an analog pressure gauge coupled to the syringe, wherein the analog pressure gauge measures a pressure required to press the mixed echogenic contrast agent and saline from the syringe.

19. The kit of claim 18, further comprising saline.

20. The kit of claim 18, further comprising instructions for performing contrast enhanced ultrasonography with the mixed echogenic contrast agent and saline to confirm placement of the intrafallopian contraceptive device.

21. The kit of claim 18, wherein the analog pressure gauge is coupled to the static mixer of the syringe.

28. The kit of claim 18, further comprising instructions for measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the analog pressure gauge, and determining distention of a uterus and pair fallopian tubes by monitoring the pressure.

22. A kit, comprising:

an echogenic contrast agent that includes microbubbles;

a dual barrel syringe having a first barrel, a second barrel, and a plunger, wherein the echogenic contrast agent that includes microbubbles is contained in the first barrel, saline is contained in the second barrel, a static mixer coupled to the first and second barrels to mix the echogenic contrast agent that includes microbubbles and the saline at a point of use, and an analog pressure gauge coupled to the syringe, wherein the analog pressure gauge measures a pressure required to press the mixed echogenic contrast agent and saline from the syringe; and

p1 instructions for use of the mixed echogenic contrast agent and saline to visualize an intrafallopian contraceptive device within a fallopian tube at a time after initial placement of the intrafallopian contraceptive device to determine occlusion of the fallopian tube by contrast enhanced ultrasonography.

23. The kit of claim 22, wherein the instructions for use further include directions to continue use of a secondary contraceptive if the fallopian tube is not fully occluded by the intrafallopian contraceptive device or if the intrafallopian contraceptive device is not properly positioned.

24. The kit of claim 22, wherein the instructions for use further include directions to discontinue use of a secondary contraceptive if the fallopian tube is fully occluded.

25. The kit of claim 22, further comprising a balloon catheter.

26. The kit of claim 22, wherein the analog pressure gauge is coupled to the static mixer of the syringe.

27. The kit of claim 22, further comprising instructions for measuring a pressure required to press the mixed echogenic contrast agent and saline from the syringe with the analog pressure gauge, and determining distention of the fallopian tube by monitoring the pressure.