System, methods and apparatus for cerebral protection

• US 8,298,169 B2
• Filed: 02/08/2005
• Issued: 10/30/2012
• Est. Priority Date: 03/22/2004
• Status: Expired due to Fees

• Current Assignee: Vahe S. Yacoubian, M. D.
• Original Assignee: Vahe S. Yacoubian, M. D.
• Inventors: Yacoubian, Vahe Stephan, Shahinian, Hrayr Karnig
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US11/053,622
• Publication Number:
  US 20050209579A1
• Time in Patent Office: 2,821 Days
• Field of Search: 604/4.01, 604/6.14, 604/6.16, 604/8, 604/19, 604/26, 604/28, 604/96.01, 604/98.01, 604/101.04, 60410201-10203, 604/104, 604/500, 604506-509, 604/907, 604/912, 604/915, 604/919, 604/921, 435/1.1, 435/1.2, 435/2, 435/283.1, 128/DIG.12, 128/DIG.13
• US Class Current: 604/28
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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

Abstract

A device, system and method for perfusing an oxygenated medium in the cerebral vasculature includes positioning pressure cuffs on upper extremities; providing a catheter having a multi-region configuration with a balloon; inserting the catheter into a subclavian or femoral vein; advancing the catheter such that the balloon is positioned substantially in the superior vena cava junction substantially proximal to the take-off of the left inominate vein. During a perfusion mode, the cuffs and balloon are inflated causing an increase in cerebral blood flow, retrogradely; and oxygenated blood which may be cooled is pumped from a femoral artery into the catheter for a suitable period. During a non-perfusion mode the cuffs and balloon are deflated. The catheter has at least two regions, namely, guide wire and fluid delivery regions. Optionally, a separate balloon inflation region may be provided.

Claims

1. A method of perfusing an oxygenated medium into a cerebral venous system of a living human, said living human comprising a right subclavian vein, a superior vena cava, a femoral artery, a heart, a first upper extremity, and a second upper extremity, the method comprising:

providing a catheter system, said catheter system comprising;

a proximal section comprising a parachute valve balloon, said parachute valve balloon comprising a first, proximal section with no openings and a second, distal section with a plurality of openings,

a mid-section comprising a length of catheter containing perfusion holes, and

a distal section comprising an occlusive balloon;

inserting the catheter system percutaneously through an entry site in said right subclavian vein and into said superior vena cava so that said occlusive balloon is positioned in said superior vena cava, and so that said parachute valve balloon is positioned in said right subclavian vein at a position allowing occlusion of flow of said oxygenated medium to said first upper extremity while also allowing said oxygenated medium flow to said cerebral venous system;

occluding said superior vena cava with said occlusive balloon during a first length of time;

preventing flow of said oxygenated medium into said second upper extremity of said living human during said first length of time;

providing said oxygenated medium from said femoral artery of said living human;

flowing said oxygenated medium through said catheter system, out of said perfusion holes, and into said cerebral venous system at a location proximal to and upstream of said occlusive balloon during said first length of time such that said oxygenated medium moves in a retrograde direction to perfuse said cerebral venous system;

occluding said right subclavian vein with said parachute valve balloon during said first length of time in response to pressure from said oxygenated medium moving retrograde into said plurality of openings in said second, distal section of said parachute valve balloon, thereby preventing oozing of said oxygenated medium out of said right subclavian vein through said entry site and preventing flow of said oxygenated medium into said first upper extremity of said living human; and

conducting each aforesaid action during beating of said heart of said living human.

2. The method of claim 1, further comprising:

discontinuing occlusion of said superior vena cava for a second length of time; and

allowing blood flow in an antegrade direction through said superior vena cava.

3. The method of claim 1, wherein occluding said superior vena cava during said first length of time comprises inflating said occlusive balloon disposed on said catheter system distal section.

4. The method of claim 1, wherein preventing flow of said oxygenated medium into said second upper extremity further comprises restricting said second upper extremity with one of a pressure cuff and a parachute valve balloon.

5. The method of claim 1, wherein flowing said oxygenated medium in a retrograde direction comprises utilizing a roller pump to remove oxygen rich blood from said femoral artery in said living human and introduce said oxygen rich blood into said cerebral venous system, optionally in combination with cooling said oxygen rich blood.

6. The method of claim 1, further comprising:

removing occlusion of said superior vena cava after said first length of time; and

allowing drainage of blood from said first upper extremity and said second upper extremity after said first length of time.

7. The method of claim 1, further comprising:

cooling said oxygenated medium prior to providing said oxygenated medium.