Device and method for assessing the geometry of a heart valve

• US 6,598,307 B2
• Filed: 08/13/2001
• Issued: 07/29/2003
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Cardiomend LLC
• Original Assignee: Cardiomend LLC
• Inventors: Hanlon, James G., Love, Jack W.
• Primary Examiner(s): Gutierrez, Diego
• Assistant Examiner(s): Guadalupe, Yaritza
• Application Number:
  US09/928,740
• Publication Number:
  US 20020020074A1
• Time in Patent Office: 715 Days
• Field of Search: 335/11, 335/12, 335/551, 335/014.5, 335/42, 335/43, 600/587, 600/29, 600/30, 600/31, 600/32, 600/593, 600/591, 623/2, 623/2.11
• US Class Current: 33/512
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• 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 2250/0097 Visible markings, e.g. indicia

Abstract

A sizer for assessing the geometry of a heart valve annulus including a handle portion for holding the sizer and a sizing portion. The sizing portion is preferably in the shape of an arch having an apex and two legs, each of which has a base adjoining the handle portion. The legs of the arched sizing portion are separated from each other by a predetermined distance that corresponds to the expected separation of commissures of a normal heart valve annulus. The height of the arch (measured from the base of each leg to the apex) corresponds to a predetermined leaflet height that approximates the expected height of a leaflet of a normal heart valve. For aortic valve reconstruction, the instrument is inserted into the opened aortic root following removal of the native valve tissue and is used to assess the distance between the commissures, the leaflet height, and the symmetry of the commissures of the exposed valve annulus.

Claims

1. A sizer for assessing the geometry of a heart valve annulus having a plurality of commissures, the sizer comprising:

a handle portion for holding the sizer; and

a sizing portion adjoining the handle portion, the sizing portion comprising a predetermined distance indicator for assessing the distance between two of the plurality of commissures by placing the sizing portion adjacent to the two of the plurality of commissures and comparing the predetermined distance indicator on the sizing portion to the distance between the two of the plurality of commissures.

2. The sizer of claim 1, wherein the sizing portion comprises an arch having two legs separated by a predetermined distance, each leg having a base adjoining the handle portion, and wherein the predetermined distance indicator is the predetermined distance between the two legs, whereby the sizing portion can be inserted into the annulus and the two legs placed adjacent to two of the plurality of commissures to compare the distance between the two of the plurality of commissures to the distance between the two legs.

3. The sizer of claim 2, wherein the annulus has a known valve diameter, and wherein the predetermined distance between the two legs approximates an expected distance between two commissures of a normal heart valve having a valve diameter substantially equivalent to the diameter of the annulus.

4. The sizer of claim 2, wherein the annulus has a contoured line of valve leaflet attachment, and wherein the shape of the arch substantially conforms to the contoured line of valve leaflet attachment.

5. The sizer of claim 4, wherein the annulus has a conical shape, and wherein the sizer further comprises a bend at the base of the legs of the arch such that the sizing portion is angled to substantially conform to the conical shape of the annulus.

6. The sizer of claim 2, wherein each leg of the arch further comprises a line at the base marking a point on each of the legs to be placed adjacent to a commissure.

7. The sizer of claim 2, wherein the arch has an apex, and wherein the height of the arch from the base of each leg to the apex corresponds to a predetermined leaflet height.

8. The sizer of claim 7, wherein the annulus has a known diameter, and wherein the predetermined leaflet height approximates an expected height of a leaflet of a normal heart valve having a valve diameter substantially equivalent to the diameter of the annulus.

9. The sizer of claim 2, wherein the arch has a textured surface for retaining a marking material to mark the line of valve leaflet attachment.

10. The sizer of claim 1, further comprising a size marking that indicates a valve diameter corresponding to the size of the sizer.

11. A sizer for assessing the geometry of a heart valve annulus having a contoured line of valve leaflet attachment and a leaflet height, the sizer comprising:

a handle portion for holding the sizer; and

a sizing portion adjoining the handle portion, the sizing portion comprising a predetermined height indicator for assessing the leaflet height by placing the sizing portion along the contoured line of valve leaflet attachment and comparing the predetermined height indicator to the leaflet height of the annulus.

12. The sizer of claim 11, wherein the sizing portion conforms in shape to the contoured line of valve attachment.

13. The sizer of claim 11, wherein the sizing portion comprises an arch having an apex and two legs, each of which has a base adjoining the handle portion, wherein the arch has a predetermined height measured from the base of each leg to the apex, and wherein the predetermined height indicator is the predetermined height of the arch, whereby the sizing portion can be inserted into the annulus and placed along the contoured line of valve attachment to compare the leaflet height of the annulus to the height of the arch.

14. The sizer of claim 13, wherein the annulus has a known diameter, and wherein the height of the arch corresponds to a predetermined leaflet height that approximates an expected height of a leaflet of a normal heart valve having a valve diameter substantially equivalent to the diameter of the annulus.

15. A sizer for assessing the geometry of a heart valve annulus having a contoured line of valve leaflet attachment, a valve diameter, and a leaflet height, the sizer comprising:

a handle portion for holding the sizer; and

a sizing portion conforming in shape to the contoured line of valve leaflet attachment comprising an arch having an apex and two legs, each of which has a base adjoining the handle portion, the arch having a height measured from the base of each leg to the apex, and wherein the height of the arch corresponds to a predetermined leaflet height that approximates an expected height of a leaflet of a normal heart valve having a valve diameter substantially equivalent to the diameter of the annulus, whereby the sizing portion can be inserted into the annulus and placed along the contoured line of valve leaflet attachment to compare the leaflet height of the annulus to the height of the arch.

16. A sizer for assessing the geometry of a heart valve annulus having a conical shape, a contoured line of valve leaflet attachment, a leaflet height, a valve diameter and a plurality of commissures, the sizer comprising:

a handle portion for holding the sizer; and

a sizing portion conforming in shape to the contoured line of valve attachment comprising an arch having an apex and two legs, each of which has a base adjoining the handle portion, wherein the base of each leg is bent such that the sizing portion is angled to conform to the conical shape of the annulus, and wherein the legs are separated from each other by a predetermined distance such that the sizing portion can be inserted into the annulus and the two legs placed adjacent to two of the plurality of commissures to compare the distance between the two of the plurality of commissures to the predetermined distance between the two legs, and wherein the arch has a height measured from the base of each leg to the apex, and wherein the height of the arch corresponds to a predetermined leaflet height that approximates an expected height of a leaflet of a normal heart valve having a valve diameter substantially equivalent to the diameter of the annulus, whereby the sizing portion can be inserted into the annulus and placed along the contoured line of valve leaflet attachment to compare the leaflet height of the annulus to the height of the arch.

17. A method of assessing the geometry of a heart valve annulus having a valve diameter and a plurality of commissures, the method comprising:

measuring the valve diameter of the annulus;

providing a sizer corresponding in size to the valve diameter of the annulus, the sizer comprising a sizing portion comprising a distance indicator that approximates an expected distance between two commissures of a normal heart valve having a valve diameter substantially equivalent to the measured valve diameter of the annulus;

placing the sizing portion adjacent to two of the plurality of commissures; and

comparing the distance between the two of the plurality of commissures to the distance indicator.

18. A method of assessing the geometry of a heart valve annulus having a contoured line of valve leaflet attachment, a valve diameter, and a leaflet height, the method comprising:

measuring the valve diameter of the annulus;

providing a sizer comprising a sizing portion, at least a portion of which has a predetermined height that approximates an expected height of a leaflet of a normal heart valve having a valve diameter substantially equivalent to the measured valve diameter of the annulus;

inserting the sizing portion into the annulus along the contoured line of valve leaflet attachment; and

comparing the leaflet height of the annulus to the predetermined height of the sizing portion.

19. A kit for assessing the geometry of a heart valve annulus having a valve diameter and a plurality of commissures, the kit comprising:

a plurality of sizers corresponding in size to various valve diameters, wherein each sizer comprises;

a handle portion for holding the sizer; and

a sizing portion adjoining the handle portion, the sizing portion comprising a predetermined distance indicator for assessing the distance between two of the plurality of commissures by placing the sizing portion adjacent to the two of the plurality of commissures and comparing the distance indicator to the distance between the two of the plurality of commissures.

20. A kit for assessing the geometry of a heart valve annulus having a contoured line of valve leaflet attachment, a leaflet height, and a valve diameter, the kit comprising:

a plurality of sizers corresponding in size to various valve diameters, wherein each sizer comprises;

a handle portion for holding the sizer; and

a sizing portion adjoining the handle portion, the sizing portion comprising a predetermined height indicator for assessing the leaflet height by placing the sizing portion along the contoured line of valve leaflet attachment and comparing the height indicator to the leaflet height of the annulus.

21. An instrument for marking a contoured line of valve leaflet attachment of a heart valve annulus, the instrument comprising:

a handle portion for holding the instrument; and

a marking portion conforming in shape to the contoured line of valve leaflet attachment, whereby a marking material can be applied to the marking portion and the marking portion can be inserted into the annulus and placed along the line of valve leaflet attachment to mark the line of leaflet attachment with the marking material.

22. The instrument of claim 21, further comprising a textured region on the sizing portion for retaining a marking material.

23. A method for marking a contoured line of valve leaflet attachment of a heart valve annulus, the method comprising:

providing an instrument having a marking portion conforming in shape to the contoured line of valve leaflet attachment;

applying a marking material to marking portion of the instrument; and

placing the marking portion of the instrument along the contoured line of valve leaflet attachment to mark the line of leaflet attachment with the marking material.

24. The method of claim 23, wherein the marking material comprises methylene blue dye.