Devices and systems for docking a heart valve

Patent metadata

Field	Value
Publication number	US-10363130-B2
Application number	US-201715422354-A
Country	US
Kind code	B2
Filing date	Feb 1, 2017
Priority date	Feb 5, 2016
Publication date	Jul 30, 2019
Grant date	Jul 30, 2019

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.

First claim

The invention claimed is:

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.

Assignees

• Edwards Lifesciences Corp

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

Classifications

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/2427 Primary

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2250/006

  modular · CPC title

• A61F2/2409 Primary

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title