Devices and systems for docking a heart valve

• US 10,363,130 B2
• Filed: 02/01/2017
• Issued: 07/30/2019
• Est. Priority Date: 02/05/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Armer, Dustin P., Franklin, Michael D., Delgado, Sergio, Joshi, Abhijeet, Sirimanne, Dinesh L., Joseph, Russell T., Abbott, Eason Michael, Nguyen, Tram Ngoc, Nguyen, Son V., Ngo, Hien Tran, Tran, Vivian, Bowman, Charles L., Rowe, Stanton J.
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US15/422,354
• Publication Number:
  US 20170231756A1
• Time in Patent Office: 909 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Expandable docking stations for docking an expandable valve can include a valve seat, one or more sealing portions, and one or more retaining portions. The valve seat can be unexpandable or substantially unexpandable beyond a deployed size. The one or more sealing portions are connected to the valve seat and extend radially outward of the valve seat. The one or more sealing portions are constructed to expand outward of the valve seat and provide a seal over a range of sizes. The one or more retaining portions are connected to the one or more sealing portions. The one or more retaining portions are configured to retain the docking station at a deployed position.

Claims

1. An expandable docking station for an expandable valve comprising:

a valve seat that is substantially unexpandable beyond a deployed size;

one or more sealing portions connected to the valve seat that are constructed to expand radially outward of the valve seat and provide a seal over a range of sizes; and

one or more retaining portions connected to the one or more sealing portions that are configured to retain the docking station at a deployed position;

wherein the valve seat and the one or more sealing portions act as an isolator that reduces or prevents radial outward forces of an expandable valve in the valve seat from being transferred to the one or more sealing portions or the one or more retaining portions.

2. The expandable docking station of claim 1 wherein the range of sizes comprises 27 mm to 38 mm.

3. The expandable docking station of claim 1 wherein, along a length L of the docking station at multiple different cross-sectional planes perpendicular to a longitudinal axis of the docking station, the docking station is configured to expand radially outwardly to different cross-sectional sizes.

4. The expandable docking station of claim 1 wherein the docking station is configured such that pressure of blood enhances the retention by the one or more retaining portions by causing the one or more retaining portions to angularly press against surrounding tissue generating a retention force counteracting force caused by the pressure of the blood.

5. The expandable docking station of claim 1 wherein the valve seat comprises a suture.

6. The expandable docking station of claim 1 wherein the sealing portion comprises a portion of a metal frame covered with a fabric.

7. The expandable docking station of claim 1 wherein the sealing portion comprises an open cell foam.

8. The expandable docking station of claim 1 wherein a portion of the docking station is permeable to blood and a portion of the docking station is impermeable to blood.

9. The expandable docking station of claim 1 wherein the one or more retaining portions extend radially outward of the one or more sealing portions when the docking station is in an unconstrained state.

10. A system comprising:

an expandable docking station that includes;

a valve seat that expands to a deployed size;

one or more sealing portions connected to the valve seat that are constructed to expand radially outward of the valve seat and provide a seal over a range of sizes of expansion; and

one or more retaining portions connected to the one or more sealing portions that are configured to retain the docking station at a deployed position;

an expandable valve that comprises;

an expandable frame that is expandable to engage the valve seat of the docking station;

a valve element connected to the expandable frame;

wherein the expandable docking station and expandable valve are configured such that, when implanted in a portion of a circulatory system, a radial outward force applied by the sealing portions to the portion of the circulatory system when within the range of sizes is less than ½

of a radial outward force applied by the expandable frame to the valve seat.

11. The system of claim 10 wherein the expandable docking station is configured such that, when implanted in the portion of the circulatory system, the diameter of the valve seat is not increased more than 3 mm by the radial outward force applied by the expandable frame to the valve seat.

12. The system of claim 10 wherein the range of sizes comprises 27 mm to 38 mm.

13. The system of claim 10 wherein the expandable docking station is configured to expand radially outwardly when implanted in the portion of the circulatory system such that the expandable docking station had different diameters at multiple different cross-sectional planes perpendicular to a longitudinal axis of the docking station.

14. The system of claim 10 wherein the expandable docking station is configured such that, when implanted in the portion of the circulatory system, pressure of blood on the expandable docking station enhances retention by causing the one or more retaining portions to angularly press against surrounding tissue generating a retention force counteracting force caused by the pressure of the blood.

15. The system of claim 10 wherein a portion of the docking station is permeable to blood and a portion of the docking station is impermeable to blood.

16. The system of claim 10 wherein the one or more retaining portions extend radially outward of the one or more sealing portion when the docking station is in an unconstrained state.

17. A method of implanting an expandable valve in a docking station comprising:

expanding a docking station such that a valve seat of the docking station expands to a valve seat deployed size and a sealing portion expands to a sealing size that is within a range of sealing sizes;

expanding a frame of an expandable valve to engage the valve seat of the docking station; and

wherein a radial outward force applied by the sealing portions over the range of sealing sizes is less than ½

of a radial outward force applied by the expandable frame to the valve seat after expanding the frame.

18. The method of claim 17 wherein a diameter of the valve seat is not increased more than 2 mm by the radial outward force applied by the expandable frame to the valve seat.

19. The method of claim 17 wherein the range of sealing sizes comprises 27 mm to 38 mm.

20. An expandable docking station comprising:

a valve seat that is unexpandable beyond a deployed size;

a sealing portion connected to the valve seat constructed to expand radially outward of the valve seat and provide a seal between the valve seat and surrounding tissue, when implanted, to prevent leakage around the valve; and

retaining portions coupled to the one or more sealing portions that are configured to retain the docking station at a deployed position;

wherein the docking station acts as an isolator that reduces or prevents radial outward forces of an expandable valve in the valve seat from being transferred to one or more of the sealing portion and the retaining portions.

21. The expandable docking station of claim 20 wherein the docking station is configured to have a continuously changing cross sectional shape moving from cross-sectional plane to cross-sectional plane along its length.

22. The expandable docking station of claim 20 wherein the retaining portions are angled such that pressure of blood enhances the retention by the retaining portions by causing the retaining portions to angularly press against surrounding tissue to generate a retention force counteracting a force caused by the pressure of the blood.

23. The expandable docking station of claim 20 wherein a portion of the docking station is permeable to blood and a portion of the docking station is impermeable to blood.

24. The expandable docking station of claim 20 further comprising one or more extensions releasably attachable to a docking station retainer of a delivery catheter, wherein each extension of the one or more extensions includes a triangular head disposable in at least one of one or more rectangular retainer recesses of the docking station retainer.