Methods and devices for Fallopian tube diagnostics

• US 10,639,016 B2
• Filed: 02/25/2016
• Issued: 05/05/2020
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Chin, Albert, Sarna, Surbhi, Snow, David W., Magana, Jesus
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Melhus, Benjamin S
• Application Number:
  US15/053,568
• Publication Number:
  US 20160278747A1
• Time in Patent Office: 1,531 Days
• Field of Search: None
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

Methods and devices for performing minimally invasive procedures useful for Fallopian tube diagnostics are disclosed. In at least one embodiment, the proximal os of the Fallopian tube is accessed via an intrauterine approach; an introducer catheter is advanced to cannulate and form a fluid tight seal with the proximal os of the Fallopian tube; a second catheter inside the introducer catheter is provided to track the length of the Fallopian tube and out into the abdominal cavity; a balloon at the end of the second catheter is inflated and the second catheter is retracted until the balloon seals the distal os of the Fallopian tube; irrigation is performed substantially over the length of the Fallopian tube; and the irrigation fluid is recovered for cytology or cell analysis.

Claims

1. A process of collecting cells from a tissue surface of a Fallopian tube in a subject comprising:

deploying a distal end of a catheter at a proximal end of the tissue surface of the Fallopian tube;

everting an inelastic balloon extendible from the distal end of the catheter to contact the tissue surface of the Fallopian tube wherein in response to everting, over-expansion of the Fallopian tube by the inelastic balloon is prevented;

partially deflating said balloon to form wrinkles on an outer surface of said balloon and capturing the cells on said wrinkles;

and withdrawing said balloon from the subject to collect the cells from the Fallopian tube.

2. The process of claim 1 further comprising shielding the cells from a surrounding environment during said withdrawing.

3. The process of claim 1 wherein said everting further comprises two or more cycles of inflation and deflation of said balloon while positioned in contact with the tissue surface.

4. The process of claim 1 wherein the catheter is deployed through an insertion of a hysteroscope.

5. The process of claim 1 further comprising placing a fiducial marker on or in a target tissue of the tissue surface during said everting.

6. The process of claim 1 wherein the catheter, or the balloon, or both, does not perforate an anatomical structure defined by the tissue surface.

7. The process of claim 1 further comprising said balloon delivering a therapeutic agent into contact with the tissue surface.

8. The method according to claim 1, further comprising extending a filament in the Fallopian tube for cell collection.

9. A method for Fallopian tube diagnostics, comprising:

deploying a distal end of a catheter at a proximal end of the Fallopian tube;

pressurizing an inelastic balloon disposed in a first inverted position, the balloon having a rounded distal end at the distal end of the catheter;

advancing the rounded distal end of the balloon into the Fallopian tube by eversion, such that an inner diameter of the balloon in the first inverted position unrolls in the Fallopian tube at the rounded end to a second everted position, thereby forming an outer diameter of the balloon;

and contacting the outer diameter of the balloon to an inner diameter of the Fallopian tube for cell collection;

wherein in response to moving between the first inverted position and the second everted position, over-expansion of the Fallopian tube by the inelastic balloon is prevented.

10. The method according to claim 9, further comprising delivering a therapeutic agent by the balloon to the Fallopian tube.

11. The method according to claim 9, further comprising placing a fiducial marker at a target tissue along the inner diameter of the Fallopian tube during eversion.

12. The method according to claim 9, further comprising extending a filament in the Fallopian tube for cell collection.

13. A method for Fallopian tube diagnostics, comprising:

deploying a distal end of a catheter at a proximal end of the Fallopian tube;

pressurizing a balloon disposed in a first inverted position;

advancing the balloon into the Fallopian tube by eversion, such that an inner diameter of the balloon in the first inverted position unrolls in the Fallopian tube to a second everted position, thereby forming an outer diameter of the balloon;

and extending a filament into the Fallopian tube, the filament having a first configuration when the balloon is in the first inverted position, and a second configuration when the balloon is in the second everted position;

wherein the balloon is inelastic, such that in response to moving between the first inverted position and the second everted position, over-expansion of the Fallopian tube by the inelastic balloon is prevented.

14. The method according to claim 13, further comprising contacting the outer diameter of the balloon, the filament, or both, to an inner diameter of the Fallopian tube for cell collection.

15. The method according to claim 13, wherein the filament is configured to curl, spread, fan, ball-up, or expand-out, or combinations thereof, in response to the balloon moving between the first inverted position and the second everted position.

16. The method according to claim 13, wherein the filament is plurality of filaments.