Color-Coded Prosthetic Valve System and Methods for Using the Same

• US 20120046738A1
• Filed: 08/23/2011
• Published: 02/23/2012
• Est. Priority Date: 08/23/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Lau, Jackie, Migliazza, John F., Oba, Travis, Peterson, John, Kim, Grace
• Granted Patent: US 10,426,606 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2250/0064 Sets comprising a plurality of prosthetic parts of different sizes
• CPC Class Codes: A61F 2250/0087 colour-coded
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.

Claims

1. A color-coded prosthetic heart valve system comprising:

a heart valve of a labeled size; and

a heart valve holder system having a stationary part in a first color attachable to the heart valve and having at least two movable parts that are movable with respect to the stationary part in a second color distinct from the first color.

2. The heart valve system of claim 1, wherein the heart valve includes a stent on an inflow end, flexible commissures projecting from the stent in an outflow direction, and flexible leaflets distributed about a valve axis and supported between the flexible commissures, the stationary part comprises a holder attached to an inflow side of the valve, and one of the two movable parts comprises a proximal end of a post that translates along the valve axis with respect to the holder and passes through a central bore in the holder, wherein the heart valve holder system further including filaments that are attached to the holder and extend through the heart valve and cross over between tips of the flexible commissures, and wherein a distal end of the post contacts the filaments along the valve axis so as to push them in a distal direction and flex the commissure tips inward.

3. The heart valve system of claim 2, wherein the holder is sutured to a sewing ring on an inflow side of the valve, and the proximal end of the post comprises an adapter sutured to the post, the adapter having the second color.

4. The heart valve system of claim 3, wherein the holder, the post, and the adapter each have a color that is in contrast to one another such that the holder is visually distinguishable from the post and the adapter, and the post is visually distinguishable from the adapter.

5. The heart valve system of claim 1, wherein one of the two movable parts comprises a flex handle configured to engage with the other movable part of the valve holder system, wherein a grip of the flex handle is in the second color.

6. The heart valve system of claim 1, wherein the valve holder system further includes a jar clip in a third color to which the stationary part is operatively removable for protection within a storage jar, the jar clip having a movement indicator thereon in the second color that indicates the direction of movement of the movable part relative to the stationary part.

7. The heart valve system of claim 1, further including an annulus sizer having a grip in the second color, the second color being associated with the labeled valve size.

8. A color-coded prosthetic heart valve system comprising:

a heart valve of a labeled size; and

a heart valve holder system attachable to the heart valve having a first stationary part in a first color and a first movable part that is movable with respect to the stationary part in a second color distinct from the first color, and a second stationary part including a movement indicator thereon in the second color that indicates the direction of movement of the first movable part relative to the second stationary part.

9. The heart valve system of claim 8, wherein the heart valve includes a stent on an inflow end, flexible commissures projecting from the stent in an outflow direction, and flexible leaflets distributed about a valve axis and supported between the flexible commissures, the first stationary part comprises a holder attached to an inflow side of the valve, wherein the heart valve holder system further including filaments that are attached to the holder and extend through the heart valve and cross over between tips of the flexible commissures, and wherein the first movable part comprises a proximal end of a post that first rotates about and then translates along the valve axis with respect to the holder and passes through a central bore in the holder, and wherein a distal end of the post contacts the filaments along the valve axis so as to push them in a distal direction and flex the commissure tips inward, the movement indicator showing the direction to rotate the post to enable it to translate along the valve axis.

10. The heart valve system of claim 9, wherein the holder is sutured to a sewing ring on an inflow side of the valve, and the proximal end of the post comprises an adapter sutured to the post, the adapter having the second color.

11. The heart valve system of claim 10, wherein the holder, the post, and the adapter each have a color that is in contrast to one another such that the holder is visually distinguishable from the post and the adapter, and the post is visually distinguishable from the adapter.

12. The heart valve system of claim 8, wherein a second movable part in the second color comprises a flex handle configured to engage with the first movable part of the valve holder system, wherein a grip of the flex handle is in the second color.

13. The heart valve system of claim 8, wherein the second stationary part comprises a jar clip in a third color to which the first stationary part is operatively removable for protection within a storage jar.

14. The heart valve system of claim 8, further including an annulus sizer having a grip in the second color, the second color being associated with the labeled valve size.

15. A method of deploying a heart valve system, comprising:

obtaining a color-coded prosthetic heart valve system comprising;

a heart valve of a labeled size including a stent on an inflow end, flexible commissures projecting from the stent in an outflow direction, and flexible leaflets distributed about a valve axis and supported between the flexible commissures; and

a heart valve holder system attachable to the heart valve having a holder attached to an inflow side of the valve in a first color, a first movable part that is movable with respect to the holder in a second color distinct from the first color, and a second stationary part including a movement indicator thereon in the second color that indicates the direction of movement of the first movable part relative to the second stationary part,

displacing the first movable part as indicated by the movement indicator and causing the first movable part to flex tips of the valve commissures inward.

16. The method of claim 15, wherein the heart valve holder system further includes filaments that are attached to the holder and extend through the heart valve and cross over between tips of the flexible commissures, and wherein the first movable part comprises a proximal end of a post that first rotates about and then translates along the valve axis with respect to the holder and passes through a central bore in the holder, and wherein a distal end of the post contacts the filaments along the valve axis so as to push them in a distal direction and flex the commissure tips inward, the movement indicator showing the direction to rotate the post to enable it to translate along the valve axis.

17. The method of claim 15, wherein a second movable part in the second color comprises a flex handle configured to engage with the first movable part of the valve holder system, wherein a grip of the flex handle is in the second color, and further comprising screwing the handle into the first movable part and using the handle to displace the first movable part.

18. The method of claim 17, wherein the first movable part comprises a proximal end of a post that first rotates about and then translates along the valve axis with respect to the holder and passes through a central bore in the holder, the method including fully screwing the flex handle into the proximal end of the post and then further rotating the flex handle as indicated by the movement indicator, thereby also rotating the post until the post can be translated axially.

19. The method of claim 18, wherein the proximal end of the post comprises an adapter sutured to the post, the adapter having the second color, the method including severing sutures connecting the adapter to the post and detaching the adapter and flex handle from the post.

20. The method of claim 19, wherein the flex holder, the post, and the adapter each have a color that is in contrast to one another such that the holder is visually distinguishable from the post and the adapter, and the post is visually distinguishable from the adapter.