Transcatheter atrio-ventricular valve prosthesis

• US 9,931,206 B2
• Filed: 05/12/2016
• Issued: 04/03/2018
• Est. Priority Date: 07/09/2010
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Weber, Josef
• Primary Examiner(s): Prone, Christopher D
• Assistant Examiner(s): DIOP, ROKHAYA
• Application Number:
  US15/153,333
• Publication Number:
  US 20160256272A1
• Time in Patent Office: 691 Days
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0403 Dowels
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0057 stretchable
• 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 2230/0067 : conical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/007 : O-rings

Abstract

A transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve in a connection channel, having a circumferential connection channel wall structure, between atrial and ventricular chambers of a heart, including an inner device to be disposed in the interior of the connection channel, the inner device having a circumferential support structure which is radially expandable and having a valve attached to the circumferential support structure, and an outer device to be disposed on the exterior of the connection channel, wherein the outer device at least partly extends around the inner device at a radial distance to the inner device, wherein the inner and outer devices form a securing mechanism for securing the circumferential connection channel wall structure therebetween.

Claims

1. A method for implanting a transcatheter atrio-ventricular valve prosthesis in a connection channel for functional replacement of an atrio-ventricular valve, the connection channel having a circumferential connection channel wall structure, the transcatheter atrio-ventricular valve prosthesis being implanted between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising:

an inner device to be disposed in an interior of the connection channel,

the inner device having a circumferential support structure, which is radially expandable, and a valve attached to the circumferential support structure, and

the circumferential support structure of the inner device having an outer circumferential groove, and

an outer device to be disposed on an exterior of the connection channel such that the outer device is aligned with the outer circumferential groove of the inner device,

the outer device at least partly extending around the inner device in at least a partial loop at a radial distance from the inner device,

the outer device being dimensioned so as to be loosely fit around the inner device such that there is no substantial radial compressive force on the inner device by the outer device, and

the inner device and the outer device forming a securing mechanism for securing the circumferential connection channel wall structure between the inner device and the outer device,

the method comprising;

providing the outer device around the connection channel;

forwarding the inner device into the interior of the connection channel; and

radially expanding the inner device and radially contracting the at least partial loop of the outer device to secure the circumferential connection channel wall structure between the inner device and the outer device.

2. The method of claim 1, further comprising:

forwarding a catheter to the ventricular chamber of the heart;

forwarding a wire through the catheter to the ventricular chamber and guiding the wire around the circumferential connection channel wall structure;

forwarding a catching wire, provided with a catching mechanism, through the catheter to the ventricular chamber of the heart;

catching a free end of the wire with the catching mechanism; and

drawing the free end of the wire into the catheter to thereby allow the wire to form the at least partial loop of the outer device that is disposed around the circumferential connection channel wall structure.

3. The method of claim 2, wherein the catching mechanism is one of a catching snare and a catching basket.

4. The method according to claim 2, wherein the catheter is forwarded to the ventricular chamber via an arterial retrograde approach such that the catheter enters the heart cavity over the aorta or via a venous access and through a puncture through the inter atrial septum (trans-septal approach) or via a puncture through the apex of the heart (trans-apical approach) or via a puncture through the atrial wall from outside the heart.

5. The method according to claim 2, wherein the catheter is forwarded to the ventricular chamber via an arterial retrograde approach such that the catheter enters the heart cavity over the pulmonary artery or via a venous access or via a puncture through the apex of the heart (trans-apical approach) or via a puncture through the atrial wall from outside the heart.

6. The method according to claim 2, wherein the step of forwarding the wire through the catheter includes guiding the wire around the circumferential connection channel wall structure such that the wire will be positioned around the posterior leaflet inside the sub-annular groove.

7. The method of claim 1, wherein the method is carried out on a beating heart.

8. The method according to claim 1, wherein the inner device is forwarded to the ventricular chamber via an arterial retrograde approach such that the inner device enters the heart cavity over the aorta or via a venous access and through a puncture through the inter atrial septum (trans-septal approach) or via a puncture through the apex of the heart (trans-apical approach) or via a puncture through the atrial wall from outside the heart.

9. The method according to claim 1, wherein the inner device is forwarded to the ventricular chamber via an arterial retrograde approach such that the inner device enters the heart cavity over the pulmonary artery or via a venous access or via a puncture through the apex of the heart (trans-apical approach) or via a puncture through the atrial wall from outside the heart.

10. The method of claim 1, wherein expanding the inner device and radially contracting the at least partial loop of the outer device activates an anchor mechanism that anchors the inner device to the circumferential connection channel wall structure.

11. The method of claim 10, further comprising removing the at least partial loop of the outer device after the inner device is secured to the circumferential connection channel wall structure.

12. The method of claim 1, wherein the circumferential support structure of the inner device has a tubular funnel portion.

13. The method of claim 12, wherein the outer device does not overlap the funnel portion after the at least partial loop of the outer device has been radially contracted.

14. The method of claim 1, wherein an outer surface of the circumferential support structure of the inner device is free of projections, and the circumferential groove of the inner device is formed as a radially inwardly deepened recess in the circumferential support structure.

15. The method of claim 1, wherein the circumferential support structure of the inner device is a stent.

16. The method of claim 1, wherein the inner device is radially expanded and the at least one partial loop of the outer device is radially contracted so that the outer device is loosely positioned within the circumferential groove of the inner device.

17. The method of claim 16, wherein a gap is provided between the inner device and the outer device when the outer device is loosely positioned within the circumferential groove.

18. The method of claim 17, wherein the gap is substantially equal to or larger than a thickness of the circumferential connection channel wall structure.

19. The method of claim 1, wherein the outer device is elastic.

20. A method for implanting a transcatheter atrio-ventricular valve prosthesis in a connection channel for functional replacement of an atrio-ventricular valve, the connection channel having a circumferential connection channel wall structure, the transcatheter atrio-ventricular valve prosthesis being implanted between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising an inner device and an outer device, and

the method comprising:

(a) providing the inner device in an interior of the connection channel,

the inner device having a circumferential support structure, which is radially expandable, and a valve attached to the circumferential support structure, and

the circumferential support structure of the inner device having an outer circumferential groove; and

(b) providing the outer device on an exterior of the connection channel,

wherein;

the outer device at least partly extends around the inner device in at least a partial loop at a radial distance from the inner device so as to have a gap between the outer device and the inner device that is substantially equal to or larger than a thickness of the circumferential connection channel wall structure, and

the inner device and the outer device form a securing mechanism for securing the circumferential connection channel wall structure between the inner device and the outer device,

in step (b), the providing of the outer device comprises;

forwarding a catheter to the ventricular chamber of the heart;

forwarding a wire through the catheter to the ventricular chamber;

guiding the wire around the circumferential connection channel wall structure;

forwarding a catching wire, provided with a catching mechanism, through the catheter to the ventricular chamber of the heart;

catching a free end of the wire with the catching mechanism, and

drawing the free end of the wire into the catheter to thereby allow the wire to form at least a partial loop that is contractible to form the outer device disposed around the circumferential connection channel wall structure; and

in step (a), the providing of the inner device comprises;

forwarding the inner device into the interior of the connection channel;

radially expanding the inner device; and

radially contracting the at least partial loop of the outer device in the outer circumferential groove of the inner device to secure the circumferential connection channel wall structure between the inner device and the outer device.

21. A method for implanting a transcatheter atrio-ventricular valve prosthesis in a connection channel for functional replacement of an atrio-ventricular valve, the connection channel having a circumferential connection channel wall structure, the transcatheter atrio-ventricular valve prosthesis being implanted between an atrial chamber and a ventricular chamber of a heart,

the transcatheter atrio-ventricular valve prosthesis comprising:

an inner device to be disposed in an interior of the connection channel,

the inner device having a circumferential support structure, which is radially expandable, and a valve attached to the circumferential support structure, and

the circumferential support structure of the inner device extending along an axis, having two axial ends, and comprising a tubular funnel portion and an outer circumferential groove, and

an outer device to be disposed on an exterior of the connection channel such that the outer device is aligned with the outer circumferential groove of the inner device,

the outer device at least partly extending around the inner device in at least a partial loop at a radial distance from the inner device and at an axial distance from the tubular funnel portion of the inner device so that a gap is disposed between the outer device and inner device and so that the outer device does not overlap the funnel portion of the inner device, and

the inner device and the outer device forming a securing mechanism for securing the circumferential connection channel wall structure between the inner device and the outer device,

the method comprising;

providing the outer device around the connection channel;

forwarding the inner device into the interior of the connection channel; and

radially expanding the inner device and radially contracting the at least partial loop of the outer device to secure the circumferential connection channel wall structure between the inner device and the outer device.