Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Combined with surgical tool
Reexamination Certificate
1997-09-26
2003-09-02
Dawson, Glenn K. (Department: 3761)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Combined with surgical tool
C623S002100, C606S001000
Reexamination Certificate
active
06613085
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to surgical instruments. More particularly, the present invention relates to a prosthetic heart valve rotator tool to orient a prosthetic heart valve into a preferred position during surgery.
BACKGROUND OF THE INVENTION
An implantable prosthetic heart valve is used as a replacement for an excised native heart valve of a patient. A typical prosthetic heart valve includes an annular valve orifice or body to provide a passageway for blood. At least one, and usually two, leaflets or occluders are mounted to an inner surface of the annular valve body and open or close with the flow of blood through the passageway.
A suture ring or sewing cuff is used to attach the heart valve to the patient's heart tissue. The sewing cuff is secured about the heart valve body and generally includes a biocompatible fabric that allows a needle and suture to pass through. The sewing cuff is placed proximate the tissue annulus at the site of the excised native heart valve. Sutures are passed through the tissue annulus and the sewing cuff, thereby securing the valve to the heart.
Prosthetic heart valves are implanted wholly or partially within the tissue annulus of the excised native valve. In some circumstances, a surgeon will want to position the prosthetic heart valve to optimize its location relative to the native structure. This is done as the sewing cuff is sutured to the heart tissue, or if the sewing cuff is rotatable relative to the valve, this can be done after the sewing cuff is secured to the heart tissue. Pending U.S. patent application 08/799,289, filed Feb. 13, 1997, entitled “ROTATABLE CUFF ASSEMBLY FOR A HEART VALVE PROSTHESIS” incorporated herein by reference, discloses a sewing cuff assembly having a resiliently deformed spring disposed along an annular seat of the valve body. The spring exerts a controlled force on the valve body, which results in a rotation-resisting torque when an outside force is applied to the valve. The rotation-resisting torque is sufficient to resist rotation during normal operation of the valve after implantation but low enough to permit the surgeon to rotate the valve during implantation.
However, in some instances, rotation of the prosthetic heart valve may be encumbered by lack of available space in which the surgeon has to work, especially in the case of small patients, for example, children. The lack of space is particularly prevalent when a prosthetic heart valve will be sutured in the mitral valve position.
FIG. 5
is a schematic diagram generally illustrating the difficulties involved with orienting a prosthetic mitral valve
1
during surgery. In
FIG. 5
, a patient's open chest is represented by plane ABCD. The patient is lying on an operating table represented by plane EFQR. A surgeon faces the patient and is generally parallel to plane ADFE. Although the chest is open, the surgeon only has access to the prosthetic mitral valve
1
(generally lying in a plane KLMN) through a small access aperture
2
bounded by line segments ADOP. The access aperture
2
opens to a small cavity proximate a plane GHIJ, which represents access to the patient's atrium
3
. In
FIG. 5
, line segment ER extends perpendicular through the patient's sternum, while planes ADFE and BCQR represent the patient's right and left lung, respectively. To successfully rotate the prosthetic mitral valve
1
, the surgeon must break the plane GHIJ and engage the prosthetic mitral valve
1
at plane KLMN through the atrium
3
with sufficient thrust or force represented by arrow
8
and maintain this force in order to rotate the prosthetic mitral valve
1
. Since the prosthetic mitral valve
1
is located in the plane KLMN which is not directly accessible from the patient's open chest and, in fact, is disposed downwardly toward the operating table at an acute angle, rotation of the prosthetic mitral valve
1
is difficult. To clarify the limited space with which the surgeon must work with, for an average man, the opening
2
may be only five inches long (line segment AD) and one and one-half inches wide (line segment AP). Access to the atrium
3
in plane GHIJ is approximately two and one-half to three inches from the opening
2
and approximately one and one-half inches from the right lung (plane ADEF). The atrium
3
is approximately one and one-half inches long. Of course, each of the foregoing dimensions is less for a smaller patient such as a child.
U.S. Pat. No. 5,403,305 discloses a prosthetic heart valve rotating device. The device includes an eccentric socket attached to a bendable shaft. The eccentric socket receives a rotator head. A spring retains the rotator head in the socket. Since an axis of the socket and rotator head is offset from the bendable shaft, rotation of the prosthetic heart valve requires rotation of the shaft about the axis of the rotator head.
SUMMARY OF THE INVENTION
A prosthetic heart valve rotator tool includes an operator actuated member and a rotator engageable with a prosthetic heart valve for selectively rotating the prosthetic heart valve. An elongated bendable member has a first end secured to the operator actuated member and a second end secured to the rotator. The elongated bendable member transfers torque between the operator actuated member and the rotator. A covering member covers at least a portion of the elongated bendable member.
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Anderson Kimberly A.
Holmberg William R.
Dawson Glenn K.
Koehler S.
St. Jude Medical Inc.
Westman Champlin & Kelly P.A.
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