Endovascular aortic valve replacement

• US 5,545,214 A
• Filed: 03/04/1994
• Issued: 08/13/1996
• Est. Priority Date: 07/16/1991
• Status: Expired due to Term

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Stevens, John H.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): CLARKE, ROBERT A
• Application Number:
  US08/206,419
• Time in Patent Office: 893 Days
• Field of Search: 623/2, 623/11, 623/66, 604/94, 604/101, 606/159, 606/170, 606/171, 606/196, 606/191, 128/DIG. 8, 128/898
• US Class Current: 606/191
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0125 Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• 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: Y10S 623/904 : Heart

Abstract

The subject invention relates to a valve replacement system together with methods of preparation and use, are provided for endovascular replacement of a heart valve in a host. The valve replacement system includes up to five components: (1) a prosthetic valve device, (2) a valve introducer device, (3) an intraluminal procedure device, (4) a procedure device capsule, and (5) a tissue cutter. The system provides for endovascular removal of a malfunctioning valve and subsequent replacement with a permanent prosthetic heart valve.

Claims

1. A method for the endovascular delivery of a replacement heart valve to an implantation site, comprising:

a) advancing though the patient'"'"'s arterial system an elongated delivery catheter having proximal and distal ends, at least one inner lumen extending therein and expandable means on the distal end thereof until the distal end of the delivery catheter is near the implantation site;

b) expanding the expandable means provided on the distal end of the delivery catheter to position the distal end thereof within the patient'"'"'s aorta downstream from the implantation site; and

c) delivering a replacement heart valve to the implantation site through the delivery catheter.

2. The method of claim 1 including securing the replacement heart valve at the implantation site.

3. The method of claim 1 wherein the expandable means on the distal end of the delivery catheter blocks the flow of blood through the aorta when expanded.

4. A method for replacing a cardiac valve endovascularly within a host'"'"'s vasculature which method comprises:

transporting an intraluminal procedure device in a procedure device capsule endovascularly through the host'"'"'s vasculature, to a valve situs whereby a barrier of said intraluminal procedure device exits from said procedure device capsule, expands in a controlled and adjustable manner, abuts the lumen of the vessel, and encircles the valve situs;

advancing a tissue cutter through a working channel of said intraluminal procedure device to said valve situs, removing said cardiac valve wherein any resulting loose matter is trapped by said barrier;

contracting said barrier, withdrawing said intraluminal procedure device into said procedure device capsule, removing said procedure device capsule, and endovascularly transporting a prosthetic valve to said valve situs by means of a valve introducer device;

expanding a bracer on said valve introducer device to position said valve introducer device correctly for insertion of said prosthetic valve device at said valve situs, expelling said prosthetic valve device from said valve introducer device and inflating a balloon of said valve introducer device at the valve situs to securely mount said prosthetic valve device at said valve situs; and

contacting said bracer, deflating said balloon, and removing said valve introducer device and said balloon from said host'"'"'s vasculature.

5. A method for performing a therapeutic procedure on a patient'"'"'s heart having an ascending aorta leading from an aortic valve which is in fluid communication with a ventricular chamber within a left portion of the patient'"'"'s heart, comprising:

a) introducing into a peripheral artery of a patient a delivery catheter having proximal and distal ends, a first inner lumen extending within the delivery catheter to a port in a distal end thereof, and expandable means on the distal end proximal to the port configured to occlude a passageway within the ascending aorta;

b) advancing the delivery catheter through the patient'"'"'s arterial system until the expandable means on the distal end of the catheter is disposed between the patient'"'"'s ascending aorta between coronary ostia and an ostium of the patient'"'"'s brachiocephalic artery;

c) expanding the expandable means on the distal end of the delivery catheter within the ascending aorta between the coronary ostia and the ostium of the brachiocephalic artery to occlude the passageway therein;

d) placing the patient on cardiopulmonary bypass; and

e) after the patient is on cardiopulmonary bypass, advancing elongated means to perform a procedure on the patient'"'"'s heart disposed within the inner lumen of the delivery catheter out the port in the distal end of the delivery catheter distally of the expandable member while the expandable member is occluding said passageway between the coronary ostia and the ostium of the brachiocephalic artery.

6. The method of claim 5 wherein a tissue cutter is advanced through the inner lumen of the delivery catheter and out the port in the distal end of the delivery catheter to sever at least part of the aortic valve from supporting tissue.

7. The method of claim 6 wherein the tissue cutter has at least one collapsible cutting blade and a drive shaft to rotate the cutting blade to sever at least part of the aortic valve from supporting tissue.

8. The method of claim 6 including advancing a replacement aortic valve through the inner lumen of the delivery catheter and securing the replacement aortic valve within the ascending aorta.