Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2000-06-22
2001-11-27
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C600S374000
Reexamination Certificate
active
06324435
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to electrical connections for cardiac devices and, more particularly, to temporary cardiac pacing wires that are adapted for use with apparatus that generate electrical signals suitable for stimulating, pacing, sensing, monitoring or defibrillating the heart.
BACKGROUND OF THE INVENTION
Devices to stimulate or regulate cardiac function have been known and used for decades. They involve a power source (pacemaker) and one or more surgical electrodes to attach the source to the heart. They are generally of two types.
Implantable pacers are intended for long-term use and, as the name suggests, are entirely implanted in the body. The other type is intended for temporary use. The temporary pacemaker is located outside the body and is connected to the heart by a surgical electrode called a “temporary pacing wire.” Although surgical electrodes are used for preparing electrocardiograms and other applications, for the sake of brevity, the description that follows is focused on temporary pacing wires.
In general, such wires are constructed of a number of fine stainless steel wires braided or twisted together to form a single, flexible, multi-strand electrode wire. The major portion of the wire is electrically insulated with a polyethylene, polytetrafluoroethylene, silicon, nylon, or another non-conducting coating, with a short length of wire at either end left uninsulated. With respect to the conventional temporary pacing wires, to the distal uninsulated end of the electrode wire there is attached, by swaging or other means, a fine curved needle for piercing the heart tissue to place the uninsulated end of the electrode in the myocardium. At the proximal end of the electrode wire, a straight (e.g., Keith-type) cutting needle is attached for piercing the thoracic wall to lead the electrode to an outer point for connection with the pacemaker. Once that has been accomplished, the needle or its sharp-pointed end is clipped or broken and the proximal end of the electrode is readied for attachment to the pacemaker as required to stimulate or regulate the beating of the heart. A single setup involves two electrodes, i.e., two temporary pacing wires.
During the time that the temporary pacing wire is performing its function, the uninsulated end of the electrode must remain anchored in the myocardium. The anchorage of the uninsulated end of the electrode to the myocardium must be secure, lest the continually beating heart cause the wire to be expelled from the myocardium. Conventionally, the electrode is sutured directly to the myocardium, or it is attached to a pad which in turn is sutured to the myocardium. Suturing causes trauma to the heart tissue. Additionally, when the need for the pacing wire has passed, it is necessary to remove from the body the wire that runs from the external pacemaker to the myocardium. The removal of the sutured wire can also cause trauma.
DESCRIPTION OF THE RELATED ART
U.S. Pat. No. 5,527,358 discloses a temporary medical electrical lead having a pad that contains holes which expose conductive sections of electrode wires to cardiac tissue in a discontinuous fashion. The pad is permanently implanted on the atrial wall and remains implanted after removal of the temporary electrodes. The conductors are mounted to the pad. Means disclosed for attaching the conductors to the pad include suturing or gluing all or some of the conductors to an outer surface of the mounting pad. The holes within the pad are used to provide for windows for the conductors to be exposed to body tissue (e.g., cardiac tissue). Bus are placed at the proximal end of the pad to prevent the conductors from accidentally dislodging while also allowing their intentional dislodgment and removal without excessive forces after treatment. Unfortunately, the pad is sutured to the atrial wall and this causes trauma. Additionally, the pad remains attached to the atrial wall even after the electrode wires are removed.
U.S. Pat. Nos. 4,553,554; 4,144,889; 3,724,467; 5,341,806; 4,057,067; 3,650,276 and 4,323,081 disclose similar pacing leads and surgical electrodes for cardiac and other surgical applications. All of these describe suturing or other mechanical means to attach the electrodes to tissue, consequently leading to undesirable trauma to the surgical patient.
Copending and commonly assigned U.S. application Ser. No. 09/451,590, filed on Nov. 30, 1999, and Ser. No. 09/451,591 filed Nov. 30, 1999, also describe electrical connectors for cardiac devices. The electrode wires are sutured to the myocardium.
In view of the inherent difficulties as described in the foregoing, there is a need for an electrical connector for a cardiac device, particularly a temporary pacing wire, where the electrode can be attached to the tissue of the patient without the unwanted trauma which occurs when the electrodes or pads to which the electrodes are attached are sutured into the cardiac tissue. Additionally, it would be desirable if all of the components of the electrical connector, including any pad which is used for mounting of the electrode, can be completely and easily removed from the patient after the connector is used.
SUMMARY OF THE INVENTION
The invention is an electrical connector for a cardiac device. The connector comprises a wire having a distal end, a first electrode at the distal end of the wire, and a patch at the distal end of the wire. The patch has an external surface and a tissue-contacting surface. The tissue-contacting surface of the patch is coated with an adhesive film for adhering the patch to the targeted tissue. The electrode is in contact with the adhesive film coated on the tissue-contacting surface of the patch.
The adhesive film applied to the tissue-contacting surface of the patch provides a sufficient bond between the patch and a targeted tissue surface. This bond is significant because it provides a reliable attachment of the electrode at the distal end of the wire of the electrical connector to the tissue surface. Significantly, the attachment of the electrode to the tissue surface can be accomplished in the most preferred embodiments of this invention without any need to suture the patch to the targeted tissue surface. Consequently, the trauma associated with the suturing of sensitive bodily tissue can be avoided or at the very least minimized.
Additionally, not only can the wire be readily removed from the patient after use, but also the patch can be easily removed from the patient as well. In this manner, it is unnecessary to leave any components of the electrical connector in the patient's body permanently, in contrast to those connectors which require suturing for the attachment of the pad to the targeted tissue surface.
The electrical connector of this invention can be used in any surgical procedure where an electrical signal in a cardiac application is required.
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Ilori Alex B.
Maurer Robert E.
Saferstein Lowell
Shchervinsky Semyon
Ethicon Inc.
Getzow Scott M.
Goodwin Matthew S.
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