Minimally invasive valve replacement system

• US 7,101,396 B2
• Filed: 10/06/2003
• Issued: 09/05/2006
• Est. Priority Date: 10/06/2003
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Nguyen, Tuoc Tan, Myers, Keith E., Artof, Jason
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/680,071
• Publication Number:
  US 20050075731A1
• Time in Patent Office: 1,065 Days
• Field of Search: 623/1.24, 623/1.26, 623 211- 219, 623/900
• US Class Current: 623/2.18
• 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 having a scalloped inflow annulus having a scalloped edge, an outflow annulus, and a plurality of leaflets between said scalloped inflow annulus and said outflow annulus; and

an expandable and collapsible stent anchoring structure composed of a shape memory metal alloy material having an undulating inflow rim having a curvature that coextends with the scalloped edge of the inflow annulus and an outflow rim connected by support posts and adopted to support the replacement valve and the outflow rim being longitudinally displaced from the replacement valve leaflets, the anchoring structure inflow rim having an undulating configuration to support the scalloped inflow annulus of the replacement valve;

said anchoring structure being dimensioned to extend longitudinally from an attachment location near the inflow annulus of a native valve sinus to an attachment location near the outflow annulus of a native valve sinus.

2. The valve assembly of claim 1, wherein said valve has three leaflets.

3. The valve assembly of claim 1, wherein said support posts are configured to coincide longitudinally with a native valve sinus commissural posts.

4. The valve assembly of claim 1, wherein said outflow rim comprises a plurality of rings.

5. The valve assembly of claim 4, wherein said plurality of rings are configured in an undulating pattern.

6. The valve assembly of claim 5, wherein said plurality of rings are substantially parallel to each other.

7. The valve assembly of claim 6, wherein said plurality of rings are connected by a vertical element.

8. The valve assembly of claim 1, wherein said inflow rim comprises a plurality of rings.

9. The valve assembly of claim 8, wherein said plurality of rings are configured in an undulating pattern.

10. The valve assembly of claim 9, wherein said plurality of rings are substantially parallel to each other.

11. The valve assembly of claim 10, wherein said plurality of rings are connected by a vertical element.

12. The valve assembly of claim 1, wherein said inflow rim comprises one ring.

13. The valve assembly of claim 12, wherein said ring is configured in an undulating pattern.

14. The valve assembly of claim 1, wherein said anchoring structure is collapsible to at least 50% of its expanded diameter.

15. A valve assembly comprising:

a replacement valve having a scalloped inflow annulus, an outflow annulus, and a plurality of leaflets between said scalloped inflow annulus and said outflow annulus; and

an expandable and collapsible stent anchoring structure composed of a shape memory metal alloy material having an inflow rim and an outflow rim connected by support posts and adopted to support the replacement valve and the outflow rim being longitudinally displaced from the replacement valve leaflets, the anchoring structure inflow rim having an undulating configuration to support the scalloped inflow annulus of the replacement valve;

said anchoring structure being dimensioned to extend longitudinally from an attachment location near the inflow annulus of a native valve sinus to an attachment location near the outflow annulus of a native valve sinus

wherein said support posts are configured to coincide longitudinally with a native valve sinus commissural posts and wherein said support posts comprise axially extending slots toward the outflow rim for the attachment of a valve'"'"'s commissural tabs.

16. The valve assembly of claim 15, wherein said support posts comprise triangular shaped elements at the inflow rim.

17. The valve assembly of claim 16, wherein said support posts further comprise a plurality of bores on either side of said slots to facilitate attachment of the commissural tabs.