Fresh donor heart valve sizer and method of use
First Claim
1. An apparatus for sizing fresh donor heart valves, the donor heart valves having a lumen and an inwardly-directed valve annulus within the lumen, the apparatus comprising:
- a sizing member having an axially-extending sizing portion with a forward end adapted to be inserted within the lumen, the sizing portion increasing in size along its axis from the forward end such that a region on the exterior thereof eventually contacts the valve annulus upon continued insertion of the sizing portion within the lumen; and
a measuring bracket connected to the sizing member and having a scale portion spaced from and generally aligned with the sizing portion, the scale portion providing markings indicating the annulus size of the donor heart valve relative to the position of the donor heart valve on the sizing portion of the sizing member.
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Accused Products
Abstract
A donor heart valve sizer and method of sizing to increase the quality and yield of, and decrease the expense of fabricating, prosthetic heart valves. The sizer includes an axially-extending sizing portion sized to fit within the lumen of a donor heart valve. The sizing portion may be conical such that a resistance to further insertion is felt when the exterior of the sizing portion contacts the annulus of the valve. A measuring bracket attached to the sizing portion includes a scale aligned with the sizing portion that indicates the final expected valve size based on the position of the fresh donor valve on the sizing portion. The measuring bracket includes regions of acceptable valve sizes, and may also include regions of unacceptable valve sizes. A method of sizing includes utilizing the sizer in the slaughterhouse to reduce the overall number of valves shipped to the valve assembly facility to obtain a particular valve size. The sizer and method are particular useful for sizing xenograft valves, especially porcine aortic valves. The sizing portion may be made of polytetrafluoroethylene, and have an included taper of approximately 4°.
51 Citations
37 Claims
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1. An apparatus for sizing fresh donor heart valves, the donor heart valves having a lumen and an inwardly-directed valve annulus within the lumen, the apparatus comprising:
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a sizing member having an axially-extending sizing portion with a forward end adapted to be inserted within the lumen, the sizing portion increasing in size along its axis from the forward end such that a region on the exterior thereof eventually contacts the valve annulus upon continued insertion of the sizing portion within the lumen; and
a measuring bracket connected to the sizing member and having a scale portion spaced from and generally aligned with the sizing portion, the scale portion providing markings indicating the annulus size of the donor heart valve relative to the position of the donor heart valve on the sizing portion of the sizing member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of measuring the annulus size of a fresh donor heart valve, comprising:
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obtaining a fresh donor heart valve having a lumen and an inwardly-directed valve annulus within the lumen;
providing a sizer having an axially-extending sizing portion adapted to fit within the lumen with an exterior surface that increases in size from a forward end along its axis;
inserting the forward end of the sizing portion into the lumen of the donor heart valve;
halting insertion of the sizing portion into tho lumen of the donor heart valve at a predetermined resistance to further insertion; and
determining the valve annulus size based on the distance that the sizing portion is inserted into the lumen. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of manufacturing prosthetic heart valves, comprising:
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providing a supply of fresh donor heart valve isolations at a slaughterhouse;
measuring the annulus size of the fresh donor heart valve isolations using a sizer having a sizing portion for insertion within the lumen of the donor heart valve isolations, the sizer being configured to identify the size of more than two sizes of the donor heart valve isolations;
selecting a subset of the supply based on the step of measuring;
shipping the subset of the supply from the slaughterhouse to a valve manufacturing facility; and
fabricating at least one prosthetic heart valve from a donor heart valve isolation selected from the subset. - View Dependent Claims (24, 25, 26, 27, 28)
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29. An apparatus for sizing a fresh donor heart valve, the donor heart valve having a lumen and an inwardly-directed valve annulus within the lumen, the apparatus comprising:
a sizer having an axially-extending sizing portion that includes a conical taper with a forward end adapted to be inserted within the lumen, the sizing portion having a length of between about 5.08-15.24 cm (2-6 inches). - View Dependent Claims (30, 31, 32)
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33. An apparatus for sizing a fresh donor heart valve, the donor heart valve having a lumen and an inwardly-directed valve annulus within the lumen, the apparatus comprising:
a sizer having an axially-extending sizing portion with a forward end adapted to be inserted within the lumen, the sizing portion having a length of between about 5.08-15.24 cm (2-6 inches), where the sizer farther includes a measuring bracket connected thereto and having a scale portion spaced from and generally aligned with the sizing portion, the scale portion providing markings indicating the annulus size of the donor heart valve relative to the position of the donor heart valve on the sizing portion. - View Dependent Claims (34, 35, 36, 37)
Specification