Endovascular aortic valve replacement

• US 5,370,685 A
• Filed: 07/16/1991
• Issued: 12/06/1994
• Est. Priority Date: 07/16/1991
• Status: Expired due to Term

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Stanford Surgical Technologies, Inc.
• Inventors: Stevens, John H.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BURKE, ELIZABETH
• Application Number:
  US07/730,559
• Time in Patent Office: 1,239 Days
• Field of Search: 623/2, 623/900, 606/159, 606/45, 606/167-172, 606/194, 600/36
• US Class Current: 623/2.11
• 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. An endovascular system for removing a heart valve from a patient'"'"'s heart, comprising:

a) an elongated delivery catheter having proximal and distal ends and an inner lumen extending therein to a port in the distal end and having expandable means disposed about the distal end of the delivery catheter which when expanded is configured to secure the distal end of the delivery catheter within an aortic location downstream from a heart valve to be removed;

b) an elongated cutting element disposed within the inner lumen of the delivery catheter which is configured to be advanced through the inner lumen of the elongated delivery catheter and out the port in the distal end thereof and to sever the heart valve from the patient; and

c) means to remove all or portions of a heart valve severed by the elongated cutting element from the patient through the distal port into the inner lumen of the delivery catheter.

2. The endovascular system of claim 1 wherein the elongated cutting element includes a blade which has a collapsed state for advancement through the elongated delivery catheter and an expanded operational state for cutting tissue.

3. The endovascular system of claim 2 wherein an elongated shaft is secured to the cutting element for rotating the blade to cut tissue.

4. The endovascular system of claim 3 wherein the blade moves into an expanded operational state when the shaft secured thereto is rotated.

5. The endovascular system of claim 1 wherein the cutting element is disposed within an enlarged distal section of the delivery catheter.

6. An endovascular system for removing a natural heart valve from its location within a patient and for delivering a replacement heart valve through an aortic passageway to or near to the location from which the natural heart valve has been removed, comprising:

a) an elongated cutting element having proximal and distal ends and means on the distal end thereof to sever the natural heart valve from its location within the patient;

b) means to remove a severed heart valve from the patient;

c) an elongated delivery catheter having proximal and distal ends and an inner lumen extending therein to a port in the distal end and having expandable means disposed about its distal end to secure the distal end within a location within the patient'"'"'s aortic passageway downstream from the location from which a natural heart valve has been severed; and

d) an elongated valve delivery member configured to be advanced through the inner lumen and out the port in the distal end of the delivery catheter and having proximal and distal ends, means on its distal end for holding a replacement heart valve and means on its distal which is operable from its proximal end for releasing the replacement heart valve at an implantation site.

7. The endovascular system of claim 6 including means advanceable through the delivery catheter to secure a replacement heart valve at the implantation site.

8. The system of claim 6 wherein the expandable means disposed about the distal end of the delivery catheter seals the aortic passageway when expanded.

9. The system of claim 6 wherein means are provided to deliver irrigation fluid distal to the delivery catheter.