Replacement aortic valve leaflets and related technology

• US 20060229716A1
• Filed: 07/29/2005
• Published: 10/12/2006
• Est. Priority Date: 04/11/2005
• Status: Active Grant

• Current Assignee: Zan Mitrev
• Original Assignee: Zan Mitrev
• Inventors: Mitrev, Zan
• Granted Patent: US 7,462,156 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Replacement aortic heart leaflets and method of making the same. The replacement aortic heart leaflets of the present invention include first and second segments. The second segment is integral with, and extends from, the first segment. A virtual line L having a predetermined length corresponding to the distance between two known aortic commissures separates the first and second segments. In another aspect of the invention, the first segment has a virtual line AM of predetermined length. In another aspect of the present invention, a leaflet-measuring device is described. In another aspect of the invention, a standard set of replacement aortic leaflets is described. Methods are provided to provide replacement aortic leaflets based on traced outlines obtained from a surgically opened aortic ring.

Claims

1. A non-native aortic heart leaflet, comprising first and second segments, wherein said second segment is integral with, and extends from, said first segment, wherein said first and second segments are separated by a virtual line L having a predetermined length corresponding to the distance between two known aortic commissures.

2. The non-native aortic heart leaflet according to claim 1, wherein said first segment has a virtual line AM of predetermined length.

3. The non-native aortic heart leaflet according to claim 1, wherein said leaflet is made of pericardium tissue derived from a horse.

4. The non-native aortic heart leaflet according to claim 1, wherein said leaflet is made of pericardium tissue selected from the group consisting of:

equine (horse) pericardium, kangaroo pericardium, human pericardium, bovine pericardium, and porcine pericardium.

5. A method of fashioning a non-native leaflet suitable for replacing a diseased or damaged aortic leaflet in an aortic valve of a patient, comprising:

obtaining an image of the patient'"'"'s aortic valve, wherein said image is of sufficient quality to reveal the location of at least two aortic commissures including first and second aortic commissures;

determining the inter-commissural distance between the first and second aortic commissures; and

fashioning a non-native leaflet, wherein said leaflet comprises first and second segments separated by a virtual line L corresponding to the inter-commissural distance, wherein said first and second segments are respectively bounded by first and second peripheries, wherein said first and second peripheries and said virtual line L share the same first and second opposite ends, wherein said virtual line L defines a midpoint and said first periphery defines a first periphery midpoint,

wherein said non-native leaflet is capable of being attached to the patient'"'"'s aortic ring between the first and second aortic commissures.

6. The method according to claim 5, further comprising the step of predetermining a length dimension AM by extending a virtual perpendicular line from the midpoint on virtual line L until the perpendicular line intercepts the aortic ring between the first and second commissures and then measuring the perpendicular line to provide the predetermined length dimension AM, and fashioning said non-native leaflet, wherein the perpendicular distance between the midpoint on virtual line L and the midpoint of said first periphery midpoint corresponds to the predetermined length dimension AM.

7. The method according to claim 5, wherein said leaflet is made of pericardium tissue derived from a horse.

8. The method according to claim 5, wherein said leaflet is made of pericardium tissue selected from the group consisting of:

equine (horse) pericardium, kangaroo pericardium, human pericardium, bovine pericardium, and porcine pericardium.

9. A method of fashioning at least one non-native leaflet suitable for replacing one, two or three diseased or damaged aortic leaflets in an aortic valve of a patient, comprising:

obtaining an image of the patient'"'"'s aortic valve, wherein said image is of sufficient quality to reveal the location of first second, and third aortic commissures;

determining first, second and third inter-commissural distances between the first and second, second and third, and third and first aortic commissures, respectively; and

fashioning first, second, and third non-native leaflets, wherein each non-native leaflet comprises first and second segments separated by a virtual line L having a length respectively corresponding to the first, second or third inter-commissural distance, wherein said first and second segments of each non-native leaflet are respectively bounded by first and second peripheries, wherein said first and second peripheries and said virtual line L of each non-native leaflet share the same first and second opposite ends, wherein said virtual line L of each non-native leaflet defines a midpoint and said first periphery of each non-native leaflet defines a first periphery midpoint,

wherein said first, second and third non-native leaflets are capable of being attached in turn to the patient'"'"'s aortic ring between the first and second aortic commissures, second and third commissures, and the third and first aortic commissures, respectively.

10. The method according to claim 9, further comprising the step of predetermining a length dimension AM for each non-native leaflet by extending a virtual perpendicular line from the midpoint of a selected virtual line L until the perpendicular line intercepts the aortic ring between a selected pair of aortic commissures and then measuring the perpendicular line to provide the predetermined length dimension AM, and repeating the process as necessary with respect to each pair of aortic commissures, and fashioning said non-native leaflets accordingly, wherein for each non-native leaflet the perpendicular distance between the midpoint on virtual line L and the midpoint of said first periphery midpoint corresponds to the corresponding predetermined length dimension AM.

11. A measuring device for measuring inter-commissural dimension L and length parameter AM, said device comprises:

a means to measure inter-commissural dimension L; and

,

a means to measure length parameter AM.

12. A measuring device for measuring inter-commissural dimension L and the length parameter AM, said device comprises:

a generally T-shaped member, wherein said T-shaped member comprises;

an L distance measuring member, wherein said L distance measuring member has first and second opposite ends and a middle section between said first and second opposite ends, wherein said L distance measuring member is less than about 40 mm in length, and wherein numeric measurement indicia are located at said first and second opposite ends of said L distance measuring member; and

an AM measuring member, wherein said AM measuring member has first and second opposite ends, wherein said first end of said AM measuring member is connected to said middle section of said L distance measuring member thereby defining said T-shaped member, wherein said AM distance measuring member is less than about 40 mm in length and wherein further numeric measurement indicia is located at said second end of said AM measuring member.

13. The measuring device according to claim 12, wherein said L distance measuring member is less than about 30 mm in length.

14. The measuring device according to claim 12, wherein said L distance measuring member is about 25 mm in length.

15. The measuring device according to claim 12, wherein said AM measuring member is less than about 30 mm in length.

16. The measuring device according to claim 12, wherein said AM measuring member is about 25 mm in length.

17. A measuring device for measuring inter-commissural dimension L and the length parameter AM, said device comprising:

a T-shaped member having a hollow vertical bore and a horizontal arm, wherein said horizontal arm is used for measuring inter-commissural dimension L;

an AM measuring shaft for measuring the AM length parameter, said measuring shaft is housed in said bore, and wherein said measuring shaft has a lower end; and

measurement indicia displayed on said shaft for measuring said AM parameter.

18. The device according to claim 17, wherein said shaft defines a lower end, wherein said indicia are displayed on said lower end of said shaft.

19. The device according to claim 17, further comprising a fixator member.

20. The device according to claim 17, wherein said shaft is movable within said bore, and further wherein said fixator holds said shaft in place inside said bore.

21. A method of fashioning a plurality of standardized non-native leaflets, comprising the step of:

fashioning a plurality of non-native leaflets,

wherein each of said leaflets comprises first and second segments separated by a virtual line L having a predetermined length,

wherein said first and second segments of each leaflet are respectively bounded by first and second peripheries,

wherein said first and second peripheries and said virtual line L share the same first and second opposite ends,

wherein said virtual line L defines a midpoint,

wherein said first periphery defines a first periphery midpoint,

wherein each leaflet incorporates a length dimension AM,

wherein AM is defined by a virtual perpendicular line that extends from the midpoint on virtual line L to the midpoint of said first periphery,

wherein said plurality of leaflets comprises leaflets with predetermined values for L and AM.

22. A method for making a replacement aortic leaflet, comprising the steps of:

obtaining a traced outline of a section of aortic ring between two selected aortic commissures located in a surgically opened aortic valve; and

cutting a replacement aortic leaflet based on said traced outline to provide a replacement aortic leaflet.

23. A method for making a replacement aortic leaflet, comprising the steps of:

providing a transparent sheet;

placing said transparent sheet over a surgically opened aortic valve AV such that said transparent sheet overlaps two selected aortic commissures and aortic ring AR found between the two selected aortic commissures;

tracing onto said transparent sheet a section of aortic ring AR found between first and second selected aortic commissures to provide a traced outline having first and second opposite ends that overlap the two selected aortic commissures 260a and 260b;

placing a sheet of pericardium tissue 820 onto said transparent sheet such that said pericardium sheet covers said traced outline;

cutting said sheet of pericardium tissue approximately along said traced outline to provide a generally curved segment having periphery S; and

cutting and trimming said pericardium tissue sheet ahead of said generally curved segment to provide an overlap segment adjoining said segment having periphery S to provide a replacement leaflet to provide a replacement aortic leaflet, wherein said overlap segment defines a free borderline periphery P.

24. A method for making a replacement aortic leaflet, comprising the steps of:

providing a transparent sheet having a linear line disposed thereon;

placing said transparent sheet over a surgically opened aortic valve AV such that said linear line overlaps two selected aortic commissures;

tracing onto said transparent sheet a section of aortic ring found between first and second selected aortic commissures to provide a traced outline having first and second opposite ends corresponding to first and second intersection points on said linear line;

placing a sheet of pericardium tissue onto said transparent sheet such that the pericardium sheet covers said traced outline;

cutting said pericardium tissue approximately along said traced outline to provide a generally curved segment having periphery S; and

cutting and trimming said pericardium tissue ahead of said generally curved segment to provide an overlap segment adjoining said generally curved segment to provide a replacement leaflet, wherein said overlap segment defines a free borderline periphery P.

25. The method according to claim 24, wherein the step of placing a sheet of pericardium tissue onto said transparent sheet such that the pericardium sheet covers said traced outline further includes the step of affixing the pericardium sheet to said transparent sheet.

26. The method according to claim 24, wherein the step of placing a sheet of pericardium tissue onto said transparent sheet such that the pericardium sheet covers said traced outline further includes the step of stapling the pericardium sheet to said transparent sheet.

27. The method according to claim 24, wherein the step of placing a sheet of pericardium tissue onto said transparent sheet such that the pericardium sheet covers said traced outline further includes the steps of stapling the pericardium sheet to said transparent sheet and ensuring said transparent sheet is face up.

28. A standard set of replacement aortic leaflets comprising a plurality of standard size leaflets, wherein each standard size leaflet has a preselected inter-commissural dimension for L and a preselected length dimension AM, wherein each said replacement leaflet comprises glutaraldehyde treated pericardium.

29. The standard set replacement aortic leaflets of claim 28, wherein said plurality of standard size leaflets includes leaflets correspond to eight specific inter-commissural dimensions for L of 17 mm, 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm, and three lengths for AM of 20 mm, 23 mm, and 26 mm to provide 30 different sized leaflets.