Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-05-17
2001-07-03
Kamm, William E. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
Reexamination Certificate
active
06256543
ABSTRACT:
BACKGROUND OF THE INVENTION
Temporary pacing wires are placed at almost every cardiac operation, but there have been no advances for many years. There are a number of current temporary pacemaker leads available for pacing after cardiac surgery. Leads (in reality a bare segment of an insulated wire) can be attached to the heart by a suture which holds the exposed wire in contact with the surface of the heart. When the lead is removed it is simply pulled out, breaking the stitch. The other way to attach the temporary lead is to attach a needle to the end of it and then pass the needle through the heart with a partial thickness bight. The needle is then cut off the wire. Exposed wire is left in contact with the heart. The wire is removed by simply pulling it out. The wire often has a series of bends or a small amount of attached plastic material to increase the friction to keep it from coming out.
There are a number of problems with these two options. Referring to
FIG. 1
, the suture method requires that the surgeon place a stitch in the form of a loop
10
and then feed the wire
12
through the loop
10
and tie it. This is somewhat tedious, especially on a beating heart
14
. The wire
12
under the suture loop to is often easily removed by even a minimum of pull on the wire and it frequently has to be replaced. When a secure wire
12
is removed, there is the risk that the surface of the heart
14
will be torn as the suture snaps or that the suture does not snap and a small divot
16
of myocardium is pulled off as also shown in FIG.
1
. This can lead to bleeding which can be fatal.
The second system is shown in
FIG. 2
whereby a wire suture
20
is passed through the heart
14
is quicker. The wire suture
20
must be passed and the wire cut off as shown at cut
22
located above a flared stop portion
24
. Flared stop portion
24
is designed to prevent the wire from being pulled back through heart
14
. However, during insertion the wire
20
frequently causes bleeding and the bleeders must be sutured. When the wire
20
is removed, there is a risk that the friction of the wire removal combined with the drag of the flared portion
24
will result in a piece of myocardium being torn, again resulting in bleeding. Also, the wire
20
frequently becomes dislodged before the chest is closed and it has to be replaced.
The prior art does not demonstrate the concept of leaving a small permanent electrode in place and separating this from the wire. This concept is very important because on removal the risk of bleeding comes when the wire is pulled through the heart muscle or when the suture must snap.
In short, current methods are somewhat tedious, can result in bleeding at insertion and removal and the leads frequently become dislodged requiring complete reinsertion. It would be very useful to ease the insertion, permit reattachment should the wire become dislodged and reduce the risk of bleeding when the wire is removed.
SUMMARY OF THE INVENTION
The invention contemplates a temporary pacing wire system which eliminates the risk of bleeding from the heart when the lead is attached. It is another object of this invention to demonstrate a temporary pacing lead which can be removed from the heart without the risk of bleeding from the heart. It is another object of this invention to demonstrate a temporary pacing lead which can be re-attached should it be inadvertently removed from the heart before the incision is closed. It is a further object of this invention to describe a temporary pacing system lead that can be quickly attached to the heart without need for suture.
An electrode is permanently attached to the heart. The electrode can be a very tiny piece of metal, such as a clip. Releasably attached to the electrode is a wire which can be removed from the electrode and reattached to it. The electrode does not cause bleeding on attachment to the heart. The electrode is not removed from the heart, so that when the wire is pulled there is no ripping of the heart tissue but only separation of the electrode from the wire. Should the wire be inadvertently removed from the electrode after it is attached it is possible to quickly reattach it.
The electrode could be sutured to the heart. More simply and more efficient would be a mechanically applied electrode clip. Clips can be applied in seconds and do not require suture. The clip could take the form of a current vessel ligation clip. Alternatively, specially modified clips for attachment could include an extension attached to a hemoclip which impales the heart. Another variation could include a clip that looks like a scorpion's pincer.
The attachment of the wire to the clip can be accomplished in a number of ways. The clip could have a small loop through which a loop of preformed pacing wire is attached. The loop on the pacing wire could open to ensure easy removal. The clip could have two parallel rabbit ear-like attachments for holding the wire in place. Many other attachments would be possible to configure.
There are multiple advantages to the invention. For example, no suturing is required with a clip-on electrode. The clip is attached by simply squeezing the handle of a small tool. The wire is preattached to the clip so that there is an instantly functioning pacemaker with no additional steps.
The pacing wire is attached reversibly to the electrode clip so that it can be easily pulled out without the risk of tearing myocardium. This is due to the fact that the clip is permanently attached to the heart and the wire slips away from or disengages the clip. There would be no direct dislodgement from the heart.
Should the wire become accidently dislodged during surgery, it can be easily reattached.
The product is easy to manufacture, package and distribute as it may take the form of existing hemoclip products.
Other advantages, objectives, and features of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description taken in conjunction with the accompanying drawings.
REFERENCES:
patent: 4010756 (1977-03-01), DuMont et al.
patent: 4214594 (1980-07-01), Little
patent: 4378023 (1983-03-01), Trabucco
patent: 4630617 (1986-12-01), Ritter et al.
patent: 4633880 (1987-01-01), Osypka et al.
patent: 5089015 (1992-02-01), Ross
patent: 5095903 (1992-03-01), DeBellis
patent: 5217027 (1993-06-01), Hermens
patent: 5350419 (1994-09-01), Bendel et al.
patent: 5476510 (1995-12-01), Eberhardt et al.
patent: 5782901 (1998-07-01), Praeger
patent: 5792217 (1998-08-01), Camps et al.
patent: 5871528 (1999-02-01), Camps et al.
patent: 5871532 (1999-02-01), Schroeppel
Kamm William E.
Wood Herron & Evans L.L.P.
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