Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2000-04-03
2002-05-28
Layno, Carl (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C607S001000, C128S897000
Reexamination Certificate
active
06397108
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to adaptors for connecting external medical devices to lead connector elements of medical leads extending percutaneously into a patient's body, and more particularly to adaptors that shield the lead connector elements and connect external medical devices to heart wires for pacing, defibrillating and monitoring the heart and nerve and muscle stimulation wires for stimulating nerves and muscles.
BACKGROUND OF THE INVENTION
Unipolar and bipolar surgically implanted temporary heart wires and temporary leads and nerve, organ, and muscle stimulation leads or wires are well known in the art, some examples of which may be found in the issued U.S. Patents listed in Table I below.
TABLE I
U.S. Pat. No.
Title
3,035,583
Conductive Sutures
3,125,095
Flexible Stainless Steel Sutures
3,244,174
Body Implantable Conductor
3,416,533
Conductive Catheter
3,664,347
Electric Heart Stimulation Method and Electrode
3,949,756
Sutures with Notch Near Needle-Suture Junction
4,010,756
Heart Pacer Lead Wire with Break-Away Needle
B1 4,010,756
Heart Pacer Lead Wire with Break-Away Needle
4,054,144
Short-Crimp Surgical Needle
4,338,947
Positive Fixation Heart Wire
4,341,226
Temporary Lead with Insertion Tool
4,442,840
Electrical Connector Apparatus and Method for a
Temporary Cardiac Pacing Wire
4,444,207
Method of Anchoring a Temporary
Cardiac Pacing Lead
4,530,368
Temporary Bipolar Pacing Lead
4,541,440
Bipolar Epicardial Temporary Pacing Lead
4,553,554
Electrical Lead and Method for Temporary
Cardiac Pacing
4,630,617
Heart Pacer Lead Wire with Pull-Away Needle
4,633,880
Surgical Electrode
4,693,258
Surgical Electrode for Cardiac Pacing and
Monitoring
4,972,833
Epicardial Pacing Lead
5,217,027
Temporary Cardiac Lead
5,241,957
Bipolar Temporary Pacing Lead and Connector
and Permanent Bipolar Nerve Wire
5,314,463
Bipolar Nerve Electrode
5,334,045
Universal Cable Connector for Temporarily
Connecting Implantable Leads and Implantable
Medical Devices with a Non-Implantable System
Analyzer
5,350,419
Cardiac Pacing Lead
5,423,876
Intramuscular Lead Having Improved Insertion
5,557,210
Universal Cable Connector for Temporarily
Connecting Implantable Stimulation Leads and
Implantable Medical Devices with a
Non-Implantable System Analyzer
5,679,022
Universal Cable Connector for Temporarily
Connecting Implantable Stimulation Leads and
Implantable Medical Devices with a
Non-Implantable System Analyzer
5,782,892
Medical Lead Adaptor for External Medical Device
5,792,217
Temporary Bipolar Heart Wire
5,871,528
Temporary Bipolar Heart Wire
5,931,861
Medical Lead Adaptor Having Rotatable
Locking Clip Mechanism
All patents listed in Table I are hereby incorporated by reference herein in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Preferred Embodiments and Claims set forth below, at least some of the temporary leads and wires disclosed in the patents of Table I may be advantageously employed with the safety adaptor of the present invention.
Certain of the patents listed in Table I disclose surgically implanted temporary heart wires or leads for use with an external unipolar or bipolar cardiac pacemaker and/or monitor or pacing system analyzer (PSA) in a manner that is are well known in the medical field. As described further below, temporary heart wires are implanted in a patient's body to extend between a heart chamber through a percutaneous incision to an external medical device and are removed after a time. Heart wires are sometimes alternatively referred to as temporary pacing leads but are distinguished from endocardial temporary pacing leads that are passed percutaneously through an incision into a vein and transvenously advanced into a heart chamber, typically employing a removable stiffening stylet, as disclosed in the above-referenced, commonly assigned '861 and '892 patents. Such endocardial temporary pacing leads are implanted and used for closed-chest temporary pacing and monitoring of a patient's heart in a variety of single and dual chamber pacing modes. When their use is terminated, they are retracted through the transvenous route, and the incision is closed.
Unipolar heart wires, e.g., the Medtronic® Model 6491, Model 6492, Model 6494, and Model 6500 Temporary Pacing Leads, and bipolar heart wires, e.g., the Medtronic® Model 6495 Temporary Pacing Lead, are shown in the above-referenced, commonly assigned '463, '217 and '328 patents. Such unipolar and bipolar heart wires are implanted in the course of a surgical procedure where the heart is surgically exposed, e.g., to provide post-surgical temporary pacing and monitoring, and are withdrawn through a percutaneous incision by applied traction when their use is to be terminated.
The elongated unipolar and bipolar heart wire bodies are constructed of a single conductor or two conductors, each conductor comprising a number of fine, stainless steel wires twisted together to form a single, flexible, multifilament wire. The major portion of each such conductor within the wire body is typically insulated with a polyethylene, polytetrafluoroethylene, silicone, nylon, or other suitable electrically non-conductive and bio-compatible materials to insulate the wires from one another (in bipolar versions) and from the environment. A short length of each such conductor at the distal end of the heart wire body is exposed to act as a pace/sense electrode when passed into the myocardium. The distal end of the most distal electrode is axially coupled to an elongated retention coil that in turn is coupled axially by a severable, non-conductive, filament to a fine, curved, surgical needle.
The fixation into the myocardium is accomplished with the heart exposed by using the curved needle to pierce the epicardium and to draw the pace/sense electrode(s) and retention coil through a portion of the myocardium without penetrating all the way through the myocardium and into a heart chamber or blood vessel. In this process, the needle is passed back out through the epicardium, and the filament coupling the needle with the fixation coil is severed after electrical testing is completed.
A tubular lead connector element is formed at the proximal end of the heart wire body and electrically connected to each insulated wire in an in-line configuration. A straight, Keith-type, cutting needle extends proximally from the proximal end of the most proximal lead connector element and is used to pierce the thoracic wall to extend the proximal portion of the heart wire body outside the body when the surgical incision accessing the heart is closed. Then, the Keith-type needle is typically clipped or broken off, and each heart wire connector element is coupled to an external medical device.
A similar nerve stimulation wire and procedure of implantation is disclosed in the above-referenced, commonly assigned, '463, '217 and '328 patents.
The proximal connector elements of such temporary endocardial pacing leads and heart wires are typically coupled to terminals of external pacemaker pulse generators, e.g., the Medtronic® Model 5348 and 5388 single chamber or dual chamber pacemaker pulse generators. A direct connection may be made if the lead or wire connector elements are compatible with the external medical device connector terminals and if the lead or wire body is long enough. During surgery, it is necessary to locate the external medical device at a distance and out of the sterile surgical field that exceeds the exposed lead or wire body length. Similarly, it may be necessary to position the external medical device at a distance from a patient who is in post-operative recovery or is otherwise bed-ridden. In these cases, it is necessary to employ elongated cables with cable connector pins that are inserted into female connector terminals of the external medical devices and cable connectors that attach to the exposed heart wire or temporary pacing lead connect
Camps Antoine N. J. M.
Cuisset Bernardt
Deruyver Benoit
Landheer Gert
Moumane Farid
Layno Carl
Medtronic Inc.
Rerry Thomas G.
Woods Thomas F.
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