Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Combined with surgical tool
Reexamination Certificate
1997-11-03
2001-04-10
Snow, Bruce (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Combined with surgical tool
Reexamination Certificate
active
06214043
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to devices for implanting heart valve prostheses. More specifically, the invention relates to a releasable hanger for a low profile holder which holds a heart valve prosthesis during implantation.
BACKGROUND OF THE INVENTION
Holders for holding and supporting heart valve prostheses during shipping and implantation are known. They are used for positioning, holding, supporting and presenting the valve during surgery. U.S. Pat. No. 3,828,787, issued Aug. 13, 1974, to Anderson et al., entitled COLLET FOR HOLDING HEART VALVE, shows a heart valve holder carried on a distal end of an elongated handle. U.S. Pat. No. 4,932,965, issued Jun. 12, 1990, to Phillips, entitled ARTIFICIAL VALVE, AND NEEDLE AND SUTURE HOLDER AND METHOD OF USING SAME, shows another heart valve holder in which the valve is held against distal ends of a pair of elongated legs during implantation.
Traditionally, heart valve replacement surgery is an involved procedure in which a sternotomy or thoracotomy is performed and the chest cavity of the patient must be widely opened to provide access to the patient's heart. This provides a surgeon with direct, unobstructed access to the heart. However, this procedure requires a prolonged period to recover from the trauma suffered to the upper torso.
A minimally invasive procedure has been developed wherein open heart surgery is performed through small incisions which eliminate the need for a lateral sternotomy. This is described in International Publication No. WO 94/18881, entitled METHOD FOR PERFORMING THORASCOPIC CARDIAC BYPASS PROCEDURES and WO 95/15715, entitled DEVICES AND METHODS FOR INTRACARDIAC PROCEDURES. In this procedure, elongated tools are used to operate on the heart through the trocars. As discussed in Publication Nos. 94/18881 and 95/15715, this procedure can be used during heart valve replacement.
The trocar requires minimal rib spreading and does not involve the significant chest trauma associated with traditional open heart surgery. One advantage of this procedure is that the recovery period can be reduced significantly.
Heart valve prostheses are typically carried in packaging which are not designed for a low profile holder such as those which may be used to perform such minimally invasive surgery. For example, the packaging may include a collar which is adapted to receive a traditional (non-low profile) holder such that the holder and prosthesis are suspended from the collar in the packaging. Such a traditional holder may also be used during implantation and couples to an elongated handle. Unfortunately, low profile holder designs may not be compatible with the packaging used with traditional holders. Further, a low profile holder is not adapted for prosthesis implantation using traditional techniques.
SUMMARY OF THE INVENTION
An apparatus for engaging a heart valve prosthesis during implantation includes a hanger and a low profile holder. The low profile holder includes a coupling area and a distal engaging surface adapted for coupling to the prosthesis. The hanger is adapted for releasably coupling to the low profile holder. In one embodiment, the hanger is slidably coupled to the holder at a groove defined in the holder. Further, in one embodiment the hanger is adapted for suspension in packaging used to transport and store the heart valve prosthesis prior to implantation. In another embodiment, the hanger may be used in conjunction with the low profile holder to perform a traditional (i.e., non-minimally invasive) implantation while the low profile holder alone may be employed to perform minimally invasive heart valve replacement surgery.
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Anderson Kimberly A.
Hinnenkamp Thomas F.
Krueger Kurt D.
Vanney Guy P.
Finucane, Esq. Hallie A.
Snow Bruce
St. Jude Medical Inc.
Westman Champlin & Kelly P.A.
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