EXPANDABLE MEMBER FOR PERFORATION OCCLUSION

• US 20160278783A1
• Filed: 06/06/2016
• Published: 09/29/2016
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Magee, Matthew Myles
• Granted Patent: US 10,932,785 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Lead extraction is the removal of one or more leads from inside the heart utilizing a lead removal catheter having a tubular sheath that is placed in the blood vessel, either subclavian or femoral. The sheath of the lead removal catheter may accidentally tear or perforate the blood vessel as it is advanced over the lead toward the heart. Such an occurrence must be dealt with quickly to prevent harm to the patient or subject. An expandable member, such as a balloon, attached to the exterior of the sheath of a lead removal catheter can be deployed temporarily adjacent the perforation in the vessel wall. Inflation of the balloon not only stops (or substantially stops) the bleeding, but, upon inflation, the balloon may include one or more channels that allow blood to continue to flow through the channel(s) until the blood vessel perforation can be repaired.

Claims

1-19. -19. (canceled)

20. A method for occluding a perforation in a blood vessel of a patient, the method comprising:

detecting the perforation in the blood vessel;

advancing a sheath carrying an inflatable balloon in a deflated state in the blood vessel;

wherein advancing the sheath comprises advancing the sheath until the inflatable balloon is substantially adjacent to the perforation in the blood vessel; and

expanding the inflatable balloon in the blood vessel, thereby at least substantially occluding the perforation in the blood vessel, wherein expanding the inflatable balloon comprises expanding the inflatable balloon to an eccentric shape in an inflated state.

21. The method of claim 20, wherein expanding the inflatable balloon comprises forming a channel bounded by an inner surface of the inflatable balloon and an outer surface of the sheath, and further comprising permitting blood to flow through the channel from a first side to a second side of the inflatable balloon.

22. The method of claim 21, wherein the channel is eccentrically disposed relative to the sheath.

23. The method of claim 20, wherein detecting the perforation in the blood vessel comprises using fluoroscopy to detect the perforation.

24. The method of claim 20, wherein the inflatable balloon comprises and/or releases a coagulant to facilitate blood clotting in the perfusion in the blood vessel.

25. The method of claim 20, wherein the perforation is formed in the course of a lead removal procedure, wherein the lead is or was attached to one of a pacemaker and defibrillator.

26. The method of claim 25, wherein the sheath comprises a lumen, and advancing the sheath comprises advancing the sheath over the lead, wherein the lead is disposed within the lumen.

27. The method of claim 26, wherein advancing the sheath over the lead comprises advancing the sheath over the lead prior to detecting the perforation in the blood vessel.

28. The method of claim 20, wherein the inflatable balloon comprises at least one imaging marker, and further comprising determining the location of the inflatable balloon within the patient by determining the location of the imaging marker.

29. The method of claim 28, wherein the at least one imaging marker comprises at least one of a radiopaque and radiolucent material.

30. The method of claim 20, wherein the eccentric shape is formed as a result of gluing, welding, bonding, or through any other suitable attachment means,