Methods and devices for fallopian tube diagnostics

• US 10,646,209 B2
• Filed: 02/03/2014
• Issued: 05/12/2020
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chin, Albert, Sarna, Surbhi, Snow, David W.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Melhus, Benjamin S
• Application Number:
  US14/764,710
• Publication Number:
  US 20150351729A1
• Time in Patent Office: 2,290 Days
• Field of Search: None
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00101 the distal tip features being detachable
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2210/1425 : Uterine tubes
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10181 : Means for forcing inflation fluid into the balloon

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 catheter comprising:

a tube having a distal end;

a balloon having a distal end secured to the distal end of the tube at a proximal end of the balloon, the balloon having a length, a majority of the length of the balloon being inelastic, said balloon being adapted to evert from an inverted position to a longitudinally extended everted position in a Fallopian tube so as prevent over-expansion of the Fallopian tube during eversion; and

an extending portion comprising a filament disposed at the distal end of said balloon moveable between the inverted position and the longitudinally extended everted position with eversion of said balloon;

wherein each of said balloon and said filament has an outer surface configured to remove and retain cells from a wall of the Fallopian tube;

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 inverted position and the everted position.

2. The catheter of claim 1 further comprising a pressurized fluid source in selective communication with said balloon.

3. The catheter of claim 1 further comprising a hysteroscope.

4. The catheter of claim 1 wherein said outer surface of the filament is smooth.

5. The catheter of claim 1 wherein said outer surface of the filament is bristled.

6. The catheter of claim 1 wherein said balloon includes an inner lumen in the everted position, an orifice at the distal end of the balloon in communication with the inner lumen, and said extending portion passes through said tube and said orifice.

7. The catheter of claim 1 wherein said filament in the everted position assumes a spiral configuration.

8. The catheter of claim 1 wherein said filament in the everted position assumes a balled configuration.

9. The catheter of claim 1 wherein said extending portion is biodegradable.

10. The catheter of claim 1 further comprising a fiducial marker.

11. The catheter of claim 1 further comprising a therapeutic agent.

12. A device for Fallopian tube diagnostics, comprising:

a tube having a distal end and positionable relative to the Fallopian tube; and

a balloon having a distal end and coupled to the distal end of the tube at a proximal end of the balloon, the balloon being movable between a first inverted position and a second everted position such that the balloon is extendable in the Fallopian tube in the second everted position; and

a filament disposed at the distal end of the balloon, wherein the filament has a first configuration relative to the balloon in the first inverted position of the balloon, and a second configuration relative to the balloon in the second everted position of the balloon;

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;

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 balloon is preventable.

13. The device according to claim 12, wherein the filament in the second configuration extends into the Fallopian tube in response to the balloon being in the second everted position.

14. The device according to claim 12, wherein the filament is plurality of filaments.

15. A device for Fallopian tube diagnostics, comprising:

a tube having a distal end and positionable relative to the Fallopian tube; and

an inelastic balloon having a distal end and coupled to the distal end of the tube at a proximal end of the balloon, the balloon being movable between a first inverted position and a second everted position such that the balloon is extendable in the Fallopian tube in the second everted position; and

a filament disposed at the distal end of the balloon, wherein the filament is configured to extend into the Fallopian tube for cell collection;

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 device according to claim 15, wherein in response to the balloon moving between the first inverted position and the second everted position, over-expansion of the Fallopian tube by the balloon is preventable.