Expandable member for perforation occlusion
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.
1. 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 the sheath comprises a lumen receiving a lead, and an outer surface having a length and a circumference,
wherein the inflatable balloon is only coupled to a portion of the circumference along the length of the outer surface of the sheath,
wherein advancing the sheath comprises advancing the sheath over the lead disposed in the lumen until the inflatable balloon is substantially adjacent to the perforation in the blood vessel;
radially expanding the inflatable balloon in the blood vessel to an inflated state, thereby at least substantially occluding the perforation in the blood vessel, whereupon radially expanding the inflatable balloon, (i) a channel is formed between an inner surface of the inflatable balloon and an outer surface of the sheath, wherein the channel comprises an eccentrically shaped cross section and (ii) a cross section of the inflatable balloon comprises an eccentric shape, wherein the eccentric shape is defined by a section between the inner surface of the inflatable balloon and an outer surface of the balloon; and
removing the lead from the patient using the lumen of the sheath, wherein the perforation is formed in the course of removing the lead from the patient, wherein the lead is or was attached to one of a pacemaker and defibrillator, and wherein the sheath is advanced over the lead prior to detecting the perforation in the blood vessel.
2. The method of claim 1 , whereupon radially expanding the inflatable balloon and forming the channel permits blood to flow through the channel from a first side to a second side of the inflatable balloon.
3. The method of claim 1 , wherein detecting the perforation in the blood vessel comprises using fluoroscopy to detect the perforation.
4. The method of claim 1 , wherein the inflatable balloon comprises and/or releases a coagulant to facilitate blood clotting in the perforation in the blood vessel.
5. The method of claim 1 , wherein the inflatable balloon comprises at least one imaging marker, and further comprising determining location of the inflatable balloon within the patient by determining the location of the at least one imaging marker.
6. The method of claim 5 , wherein the at least one imaging marker comprises at least one of a radiopaque and radiolucent material.
7. The method of claim 1 , wherein the inflatable balloon is coupled to the length of the outer surface of the sheath by gluing, welding, or bonding.