Surgery – Instruments
Reexamination Certificate
1999-05-26
2001-03-13
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
C600S146000, C600S143000, C600S144000, C604S524000, C604S530000, C604S532000
Reexamination Certificate
active
06200306
ABSTRACT:
BACKGROUND
The disclosures herein relate generally to a holder for a prosthetic heart valve and more particularly to a clip for maintaining a bent position in the shaft portion of the holder.
When attaching a universal mechanical heart valve during a surgical procedure, a surgeon does not directly handle the valve, thereby maintaining the valve sterile and avoiding possible damage to the valve. Typically a valve holder is coupled with a flexible pusher-rotator handle. The valve holder is attached to the valve. The handle permits the surgeon to push and rotate the valve into the natural heart valve annulus for final suturing.
The handle and valve holder must allow the surgeon to position the valve and sewing cuff in the natural heart valve annulus by manually applied axial and rotational movement of the flexible handle. Current handles incorporate a flexible shaft formed of a super elastic material such as the product sold under the name Nitinol. As such the shaft can be flexed and rotated in a flexed position to facilitate proper placement of the mechanical valve in the natural valve annulus. Current flexible shafts can require two points of contact (hand positions) in some situations in order to properly flex the shaft into position and rotate the valve and valve holder into the annulus. One of the points of contact is on the handle and the other point of contact is on the shaft near the valve holder. This is especially the case when operating on the mitral valve, where getting a hand on the shaft close to the valve holder, is difficult due to space limitations. Trying to manipulate the valve holder at the end of the flexible shaft with another instrument, positioned near the valve holder, is difficult due to the size and flexibility of the shaft. Therefore, attempting to bend the flexible device to seat the mechanical valve is difficult.
In addition, when the flexible shaft is in a bent position, there is a possibility that the valve holder end of the shaft could spring-back to the natural straight configuration when the holder is disengaged from the mechanical valve. This, or an unexpected spring-back action, would be undesirable.
An example of a flexible shaft device is described in U.S. Pat. No. 5,582,607 which discloses a heart valve prosthesis rotator which also has an annealed stainless steel shaft which can be bent by the surgeon interoperatively. The shaft will retain its shape after bending. Surrounding the shaft is a drive coil which connects a rotator head at a proximal end of the shaft to a drive knob at a distal end of the shaft and adjacent a handle. By turning the drive knob, a surgeon can turn the rotator head, thus orienting the prosthetic heart valve. Torsional motion is carried along the path defined by the bendable shaft so that the rotator head can be turned without displacing the handle of the heart valve rotator.
Therefore, what is needed is a device which avoids the need for a two-point contact in order to bend and hold the flexible shaft of a pusher rotator and which avoids the possibility of shaft spring-back either inadvertently or when the valve holder is disengaged from the mechanical valve.
SUMMARY
One embodiment, accordingly, provides a bendable component which can hold a shape and can maintain that shape while attached to a flexible shaft which is rotatable in the component. To this end, a bend clip for a flexible pusher-rotator includes a bendable member formed of a material which is bendable to hold a fixed shape. The bendable member includes multiple contact points for supporting a flexible shaft at spaced apart support points and maintaining the flexible shaft rotatable in a flexed position.
A principal advantage of this embodiment is that the bend clip avoids the need for a two-point hand contact in order to bend and hold the flexible shaft of a pusher-rotator, and avoids a possible spring back of the shaft either inadvertently or when a valve holder at a terminal end of the shaft is disengaged from a mechanical valve being installed.
REFERENCES:
patent: 5255668 (1993-10-01), Umeda
patent: 5582607 (1996-12-01), Lackman
patent: 5749828 (1998-05-01), Solomon et al.
patent: 5772655 (1998-06-01), Bauer et al.
patent: 5873817 (1999-02-01), Kokish et al.
patent: 5941818 (1999-08-01), Hori et al.
patent: 5976075 (1999-11-01), Beane et al.
patent: 6004329 (1999-12-01), Myers et al.
Heinrich Christopher
Klostermeyer Tammi E.
Dvorak Linda C. M.
Lyren Philip S.
Ram Jocelyn
Scott Timothy L.
Sulzer Carbomedics Inc.
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