Bipolar vascular sealing apparatus and methods

• US 6,398,782 B1
• Filed: 05/15/1995
• Issued: 06/04/2002
• Est. Priority Date: 10/13/1992
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pecor, Robert, Evans, David J., Mills, Timothy C., Konno, Mark A., Taymor-Luria, Howard, Roteliuk, Luchy D., Mooney, Charles R., Currier, Clifford E.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US08/440,624
• Time in Patent Office: 2,577 Days
• Field of Search: 606/45-50, 607/100-104, 604/21
• US Class Current: 606/50
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: H04L 69/40 : for recovering from a failure of a protocol instance or entity, e.g. service redundancy protocols, protocol state redundancy or protocol service redirection management of faults, events, alarms or notifications in data switching networks H04L41/06

Abstract

The method, device and system for electrical sealing of a puncture opening in a blood vessel wall. In a first embodiment, a vascular sealing probe has two bipolar electrodes formed thereon, is insertable to a position whereat the bipolar tip is adjacent the blood vessel puncture site to effect electrocauterization or electrocoagulation of the puncture site. In a second embodiment the bipolar vascular sealing probe has a first electrode formed thereon and an electrode-guide wire has the second bipolar electrode formed thereon. The electrode-guide wire is passable through a lumen formed in the probe such that the second electrode on the electrode-guide wire is positioned close enough to the first electrode positioned on the probe to permit electrical current to pass therebetween.

Claims

1. A bipolar vascular sealing probe device for sealing a puncture in a blood vessel comprising the combination of:

a) a probe comprising;

an elongate probe body having a proximal end, a distal end and a guide wire passage lumen extending through at least a portion of said probe body;

a first bipolar electrode formed on said probe body comprising an electrically conductive member positioned near the distal end of said probe body and having a distal face portion which is concave;

a first conduction pathway extending longitudinally through said probe to carry electrical current from the proximal end of said probe body to said first bipolar electrode; and

b) an electrode-guide wire device comprising;

an elongate guide wire having a proximal end, a distal end and an outer surface;

a second bipolar electrode formed on a discrete distal region of the outer surface of said guide wire;

a second conduction pathway extending longitudinally through said guide wire to carry electrical current to said second bipolar electrode formed thereon;

wherein said guide wire being passable through the guide wire passage lumen of said probe such that a portion of said guide wire protrudes out of said guide wire passage lumen, and further such that said second bipolar electrode is located in sufficient proximity to said first bipolar electrode such that electrical current may pass between said first bipolar electrode and said second bipolar electrode.

2. A bipolar vascular sealing probe device comprising the combination of:

a) a probe comprising;

an elongate probe body having a proximal end and a distal end;

a first bipolar electrode formed on said probe body at a first location;

a first conduction pathway extending longitudinally through said probe to carry electrical current from the proximal end of said probe body to said first bipolar electrode;

a guide wire passage lumen extending longitudinally through at least a portion of said probe body and opening through a guide wire passage aperture in the distal end of said probe body; and

b) an electrode-guide wire device comprising;

an elongate guide wire having a proximal end, a distal end and an outer surface, said guide wire being formed of electrically conductive material and having an electrically insulative coating formed on the outer surface thereof, except for an uncoated region located a spaced-distance from the distal end of the guide wire, said uncoated region forming a second bipolar electrode, and;

a second bipolar electrode formed on at least a region of the outer surface of said guide wire;

a second conduction pathway extending longitudinally through said guide wire to carry electrical current to said second bipolar electrode formed thereon;

wherein said guide wire being passable through the guide wire passage lumen of said probe such that a portion of said guide wire protrudes out of said guide wire passage aperture in the distal end of said probe body, and further such that said second bipolar electrode is located in sufficient proximity to said first bipolar electrode such that electrical current may pass between said first bipolar electrode and said second bipolar electrode.

3. The device of claim 2 wherein the guide wire passage lumen formed in said probe is a monorail type lumen which extends through only a distal portion of the probe body.

4. The device of claim 2 wherein said guide wire passage lumen formed in said probe is an over-the-wire type lumen which extends longitudinally through the entire probe body.

5. The device of claim 2 wherein said probe body has a length of 15-150 cm and a diameter of 4-13 French.

6. The device of claim 2 wherein said electrode-guide wire device comprises an elongate guide wire having a length of 15-300 cm and a diameter of 0.014-0.038 inches.

7. The device of claim 2 wherein said first bipolar electrode comprises an electrically conductive band positioned about the outer surface of said probe body.

8. The device of claim 7 wherein said electrically conductive band is positioned on the distal end of said probe body and wherein an electrically insulative plug member, having a disc portion formed on the distal end thereof, the disc portion of said insulative plug member and said electrically conductive band having outer diameters which are substantially equivalent to one another, said disc-portion of said insulative plug member thereby forming an electrically insulative distal end on said probe body, distal to said first bipolar electrode, and wherein said guide wire passage lumen extends through said electrically insulative plug member.

9. The device of claim 2 wherein said first bipolar electrode comprises an electrically conductive member positioned on the distal end of said probe body.

10. The device of claim 9 wherein said electrically conductive member has a distal face portion which is concave.

11. The device of claim 9 wherein said electrically conductive member has a distal face portion which is convex.

12. The device of claim 9 wherein said guide wire passage lumen extends through said electrically conductive member, and wherein an electrically insulative lining is disposed within the portion of said guide wire passage lumen which extends through said electrically conductive member.

13. The device of claim 2 wherein said probe further comprises:

a locator apparatus formed in said probe body at a spaced distance from the distal end of said probe body, said locator apparatus being operative to sense when said locator apparatus is in contact with a blood vessel wall puncture site, thereby indicating that further movement of the probe by a distance equal to said spaced distance will result in positioning of the distal end of said probe adjacent said blood vessel wall puncture site.

14. The device of claim 13 wherein said locator apparatus comprises a locator notch.

15. The device of claim 14 wherein said probe body has a longitudinal axis, and wherein said locator notch comprises:

a) an annular shoulder surface formed in said probe body, said shoulder surface being in a plane which is substantially perpendicular to the longitudinal axis of said probe body; and

,

b) a tapered region of said probe body located immediately proximal to said abutment shoulder, said tapered region being of gradually narrowed cross sectional dimension.