Geometrical instruments – Gauge – Anatomical
Reexamination Certificate
2000-11-17
2004-01-20
Fulton, Christopher W. (Department: 2859)
Geometrical instruments
Gauge
Anatomical
C033S555100, C033S542000
Reexamination Certificate
active
06678962
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to measuring instruments and methods and is particularly directed to instruments and methods used to measure the size and dimensions of heart valves in the surgical operating room at the time of heart valve reconstruction or replacement.
BACKGROUND OF THE INVENTION
When a surgeon must replace one or more of a patient's heart valves because of disease or defect of the native valve(s), the surgeon must identify the diameter of the patient's annulus in order to select the correct size replacement heart valve. The measurement of heart valve diameter in the operating room is typically done with some type of plug gauge. Gradated sizes of plug gauges, typically in 2 millimeter increments are used to find the best fit for any given valve annulus. The advent of homograft valves and, more recently, methods for reconstructing heart valves, makes it desirable to determine more than simply the best fit diameter. For operations involving the use of homograft valves, stentless heterograft valves, and any one of several methods of aortic or pulmonic heart valve reconstruction being used, it is also desirable to measure the height of the leaflets and the symmetry, or lack thereof, of the valve commissures. To meet these requirements, an instrument and methods have been developed that can be used in the operating room to assess valve geometry more completely than has been possible in the past.
SUMMARY OF THE INVENTION
The present invention is comprised of methods and instruments that can be used to measure the diameter of the valve annulus at the commissural level, to compare the height and lines of attachment of the individual leaflets with reference to a normalized geometry, and to determine the symmetry of the valve commissures. One preferred embodiment of the present invention comprises a circular piece with three equally spaced radial spokes that converge in the center to a socket to which a handle can be attached. Curved legs that correspond to the geometry of the normal native valve leaflet anatomy, as described in published medical articles, are attached to the circular piece.
In a typical operation to replace or to reconstruct an aortic or pulmonic valve, the diseased native valve is removed down to the annulus of the valve. After this has been done, the valve is sized. With the present invention, sizers of graded dimensions are used until the best-fit diameter at the commissural level is determined. With that sizer inserted in the aortic or pulmonic root, the height of each leaflet from its base to the apex of its commissures can be compared with the expected dimensions for that valve, based on published dimensions. The symmetry of the valve can be judged by aligning any given radial spokes of the circular piece with one commissure, and then noting the spacing of the remaining two commissures. The radial spokes each have a width that corresponds to an arc of the circle that encompasses the normal expected variation from perfect symmetry. Deviations from expected normal leaflet height or symmetry can be readily appreciated and used to increase the precision of the planned surgical procedure.
REFERENCES:
patent: 2706338 (1955-04-01), Ackerman
patent: 3161041 (1964-12-01), Amburgey
patent: 3875668 (1975-04-01), Taylor
patent: 4211241 (1980-07-01), Kaster et al.
patent: 4470157 (1984-09-01), Love
patent: 5042161 (1991-08-01), Hodge
patent: 5360014 (1994-11-01), Sauter et al.
patent: 5489296 (1996-02-01), Love et al.
patent: 5571174 (1996-11-01), Love et al.
patent: 5603165 (1997-02-01), Bernhardt et al.
patent: 5697382 (1997-12-01), Love et al.
patent: 5716399 (1998-02-01), Love
patent: 5814096 (1998-09-01), Lam et al.
patent: 5961539 (1999-10-01), Northrup, III et al.
patent: 6019739 (2000-02-01), Rhee et al.
patent: 6042554 (2000-03-01), Rosenman et al.
patent: 6129758 (2000-10-01), Love
patent: 6319281 (2001-11-01), Patel
patent: 6350281 (2002-02-01), Rhee
patent: 6383147 (2002-05-01), Stobie
patent: 6425902 (2002-07-01), Love
patent: 6575921 (2003-06-01), Vanden Hoek et al.
patent: 6578281 (2003-06-01), Takahashi
patent: 6598307 (2003-07-01), Love et al.
patent: 2002/0133226 (2002-09-01), Marquez et al.
patent: 2003/0078651 (2003-04-01), Schoon et al.
Swanson, W. Milton; Clark, Richard E., Dimentions and Geometric Relationships of the Human Aortic Value as a Function of Pressure, Circulation Research, vol. 55, Dec. 1974.
Zioupos, P.; Barbanel, J. C.; Fisher, J., Mechanical and optical anisotropy of bovine pericardium, Medical & Biological Computing, Jan. 1992.
Zioupos, P.; Barbanel, J. C.; Fisher, J.; Wheatly, D.J., Changes in the mechanical properties of bioprosthetic valve leaflets made of bovine pericardium, as a result of long-term conditioning in vitro and implantation in vivo, Journal of Materials and Medicine 4 (1993) 531-537.
Ioupos, P.; Barbanel, J. C.; Fisher, J., Anisotropic elasticity and strength of glutaraldehyde fixed bovine pericardium for use in pericardial bioprosthetic valves, Journal of Biomedical Materials Researchm Vo. 28, 49-57 (1994).
Zioupos, P.; Barbanel, J. C., Mechanics of native bovine pericardium, Biomaterials 1994, vol. 15, No. 9.
Hanlon, James C.; Suggit, Robert W.; Gibbs, Evan; McMeeking, Robert M.; Love, Jack W., Geometric Optimization of a Tissue Pattern for Semilunar Valve Reconstruction, J. Heart Valve Dis, vol. 8, No. 6, Nov. 1999.
Love, Jack W., Autologous Pericardial Reconstruction of Semilunar Valves, J Heart Valve Dis, /vol. 7, No. 1, Jan. 1998.
Hanlon James G.
Love Jack W.
Bryan Cave LLP
Cardiomend LLC
Fulton Christopher W.
Guadalupe Yaritza
LandOfFree
Device and method for assessing the geometry of a heart valve does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Device and method for assessing the geometry of a heart valve, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Device and method for assessing the geometry of a heart valve will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3193597