Electrical connectors – With stress relieving means for conductor to terminal joint – Curved conductor path
Reexamination Certificate
1999-11-30
2001-04-17
Patel, Tulsidas (Department: 2839)
Electrical connectors
With stress relieving means for conductor to terminal joint
Curved conductor path
C439S909000, C607S122000
Reexamination Certificate
active
06217369
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to electrical connectors 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. To the distal uninsulated end of the electrode wire there is attached, by swaging or other means, a fine curved needle for piercing the 5 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 off 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 must be secure, lest the continually beating heart cause the wire to be expelled from the myocardium. 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 process of preparing the proximal ends of the pacing wires (electrodes) to the pacemaker requires numerous steps and is time consuming. Not only do the proximal ends of the pacing wires require removal from the Keith-like needles, but separate steps are required to make them suitably adapted for attachment to electrodes (terminals) within the pacemaker.
DESCRIPTION OF THE RELATED ART
U.S. Pat. No. 4,693,258, issued on Sep. 15, 1987 to Osypka et al., discloses an electrode connector assembly that can be used to electrically connect the proximal end of a pacing wire (with insulation removed) to the socket of a pacing or monitoring instrument. This approach is useful but requires many small parts to be assembled. This may prove to be difficult and time consuming to work with in the operating room environment. Also, multistrand wires have a tendency to fray which adds to difficulties. Additionally, small parts are prone to be easily lost.
U.S. Pat. No. 4,633,880, issued on Jan. 6, 1987 to Osypka et al., discloses an implantable bipolar electrode assembly where the two distal ends of the wire are received in an electrically conductive sleeve (pole). One wire is in electrical contact with the sleeve and the second wire passes through the sleeve. The distal end of the second wire is stripped of insulation to provide electrical contact with heart tissue. The stripped section is configured to introduce mechanical resistance to its removal from heart tissue. Although this electrode assembly is effective in delivering a bipolar signal to the heart, it is not intended for use as a direct electrical connection with a pacemaker.
U.S. Pat. No. 5,792,217, issued on Aug. 11, 1998 to Camps et al., discloses an arrangement in which the proximal ends of two pacing wires can be simultaneously broken away from a Keith-type needle. Affixed to the proximal end of each wire is an electrical connector that is suitably dimensioned to connect to a pacing or monitoring instrument. This arrangement requires complex manufacturing processes to fabricate. Because the Keith-type needle accommodates two electrical connectors in a side-by-side fashion, the needle is approximately twice as large as those typically used. The larger needle can cause undesirable tissue trauma.
In view of the foregoing, there is a need for a simple, efficient and reliable mechanism for connecting the proximal ends of bipolar temporary pacing wires to a pacing or monitoring instrument. The mechanism should have few parts, be easy to manufacture and be consistent with minimal tissue trauma to the patient.
BRIEF SUMMARY OF THE INVENTION
An object of this invention is to provide a novel and improved surgical electrical connector that can be connected to a medical instrument in a simple and timesaving manner.
Another objective of the invention is to provide an electrical connector that can be electrically connected directly to the socket of a pacing or monitoring instrument. A further object of the invention is to provide an assembly requiring minimal tissue trauma during installation and simultaneously allowing for two electrical connections to be established with a pacing or monitoring instrument.
An additional object of the invention is to provide an electrical connector with partially insulated ends.
Still another object of the invention is to provide an electrical connector assembly that is smaller in diameter than the Keith-type needle used to guide the connector to the outside of the body.
With the foregoing objects in mind, the present invention relates to an electrical connector assembly in which a conductive lead adapted for connection to a source of electrical signals is folded over on itself. The present invention is especially suited for use in conjunction with a temporary cardiac pacing wire which includes an electrically conductive flexible wire having two elongated conductive sections at its proximal end. The conductive sections can be plugged a pair of socket-like terminals of a pacing or monitoring instrument which generates electrical signals for stimulating, pacing, sensing, monitoring or defibrillating the heart of a patient. One conductive section results from the distal end of a Keith-type needle that breaks away from the needle. This section can be plugged directly into one of the socket-like terminals of the pacing or monitoring instrument. The other conductive section is suitable for connecting to the other socket-like terminal when folded over on itself, or an adjacent insulated portion of wire, to provide dimensional thickness necessary for an electrically secure connection. To facilitate its connection to the pacing or monitoring instrument in a plug-like fashion, this section may have a length which is more than ten times the diameter of the Keith-type needle, while having a maximum lateral dimension (e.g., a diameter in the case of a circular cross section) which is smaller than or equal to the diameter of the Keith-type needle.
The invention has the advantage of ease of use without requiring additional pin-plugs or other assemblies. Also, the invention allows the use of needles, wires and connectors sized smaller than or equal to the size of existing Keith-type needles.
REFERENCES:
patent: 4010756 (1977-03-01), DuMont et al.
patent: 4341226 (1982-07-01), Peters
patent: 4442840 (1984-04-01), Wojciechowciz, Jr.
patent: 4541440 (1985-09-01), Parsonnet
patent: 4633880 (1987-01-01), Osypka et al.
patent: 4693258 (1987-09-01), Osypka et al.
patent: 5217027 (1993-
Clerc Claude O.
Ilori Alex
Shchervinsky Semyon
Ethicon Inc.
Patel Tulsidas
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