Minimally invasive valve replacement system

• US 20050075724A1
• Filed: 10/06/2003
• Published: 04/07/2005
• Est. Priority Date: 10/06/2003
• Status: Abandoned Application

• Current Assignee: Keith E. Myers, Oleg Svanidze
• Original Assignee: Keith E. Myers, Oleg Svanidze
• Inventors: Svanidze, Oleg, Myers, Keith E.
• Application Number:
  US10/680,562
• Publication Number:
  US 20050075724A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0028 cooled
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

Methods and systems for minimally invasive replacement of a valve. The system includes a collapsible valve and anchoring structure, devices and methods for expanding the valve anchoring structure, adhesive means to seal the valve to the surrounding tissue, a catheter-based valve sizing and delivery system, native valve removal means, and a temporary valve and filter assembly to facilitate removal of debris material. The valve assembly comprises a valve and anchoring structure for the valve, dimensioned to fit substantially within the valve sinus.

Claims

1. A valve assembly comprising:

a replacement valve;

an anchoring structure; and

native valve removal means comprising cutting means selected from the group consisting of radiofrequency, ultrasound, and sharp edge cutting means.

2. The valve assembly of claim 1, wherein said valve is positioned internally to said anchoring structure.

3. The valve assembly of claim 2, wherein said valve comprises an inflow annulus, an outflow annulus, and a plurality of leaflets.

4. The valve assembly of claim 3, wherein said inflow annulus is scalloped.

5. A method of endovascularly implanting a valve assembly through a vessel, comprising the steps of:

providing a collapsibly expandable valve assembly comprising an anchoring structure with an annulus base and a collapsible valve connected to the anchoring structure, the collapsible valve being configured to permit flow in a direction and prevent flow in an opposite direction, the anchoring structure having cutting means located at about the annulus base for cutting a native valve;

passing the valve assembly through the vessel with the anchoring structure in a collapsed state;

advancing the cutting means against the native valve with the anchoring structure in a partially expanded state;

cutting at least a portion of the native valve by deploying the cutting means; and

securing the valve assembly to the desired valve location with the anchoring structure in the expanded state.

6. The method of claim 5, wherein the collapsibly expandable valve is a biological valve.

7. The method of claim 5, wherein the collapsibly expandable valve is a nonbiological valve.

8. The method of claim 5, wherein the cutting means comprises a plurality of sharp edge elements, each sharp edge element having a sharp end enabling said sharp edge element to cut through at least a portion of the native valve.

9. The method of claim 5, wherein the cutting means comprises a plurality of electrode elements, and wherein radiofrequency energy is delivered to each electrode element enabling said electrode element to cut through at least a portion of the native valve.

10. The method of claim 5, wherein the cutting means comprises a plurality of ultrasound transducer elements, and wherein ultrasound energy is delivered to each transducer element enabling said transducer element to cut through at least a portion of the native valve.

11. The method of claim 5, wherein the at least a portion of the native valve is a leaflet.

12. The method of claim 5, wherein the advancing step is carried out with the anchoring structure placed on an inflatable balloon, and wherein the anchoring structure is in a partially expanded state.

13. The method of claim 5, wherein the securing step is carried out by inflating a balloon so that the balloon moves the anchoring structure from the partially collapsed state to the expanded state.

14. The method of claim 5, wherein the passing step is carried out by coupling the anchoring structure to a catheter.

15. The method of claim 5, wherein the catheter further comprises filter means for entrapping the cut portion of the native valve.

16. The method of claim 5, wherein the providing step is carried out with the collapsible valve having three valve leaflets.

17. A valve assembly to be endovascularly implanted through a vessel, comprising:

a collapsibly expandable anchoring structure having an inflow rim, wherein the inflow rim comprises cutting means sized and configured for cutting at least a portion of a native valve; and

a collapsible valve connected to the anchoring structure, wherein the collapsible valve is configured to permit flow in a direction and prevent flow in an opposite direction.

18. The valve assembly of claim 17, wherein the cutting means is selected from the group consisting of radiofrequency, ultrasound and sharp edge cutting means.