Patent Grant
8996130
The present disclosure relates generally to temporary insulating connectors, also referred to as temporary “touch-proof” connectors for coupling with lead connector elements of medical leads extending percutaneously into a patient's body, and more particularly to temporary touch-proof connectors that shield the lead connector elements from making contact with earth or potentially hazardous voltages when not in use.
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.
All patents listed in Table I are hereby incorporated by reference herein in their respective entireties. 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 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 (J-2M) 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, preferably at the end, 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where the heart is surgically exposed, e.g., to provide post-surgical temporary pacing and monitoring, and are withdrawn through a percutaneous incision by applied traction when their use is to be terminated.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 or similar devices which are available on the market. Other suitable connections are also considered, for example if the lead length is short, by using an extension cable which terminates in the external pacemaker pulse generator. 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. In certain situations, the connector elements are not coupled to terminals of pulse generators and thus the pacing leads and heart wires are coiled up and positioned for future use, for example by being taped to a patient's chest. When not coupled to terminals of a pulse generator, temporary touch-proof connectors are used so as to prevent connector elements from contacting earth or hazardous voltages.
Concerns relating to the safety of leaving any lead connector element exposed have been voiced by regulatory agencies over many years. It is dangerous to a patient to conduct electrical current or static electricity through a lead into a patient's body, particularly through a temporary pacing lead or heart wire attached to the heart. Connector regulations IEC 60601-1 dictate that medical leads shall be constructed in such a way that no conductive part or surface of a connector element in the part of the medical lead remote from the patient can contact earth or possibly hazardous voltages. Moreover, regulations IEC 60601-1 and 60601-2-31 including amendment 1 requires connections to a patient be equipped with touch-proof connectors that can only be implemented by industrial manufacturing.
Temporary touch-proof connectors are disclosed that include an insulating body defining a passageway having an open leading end sized to receive a connector element of a medical lead and an enclosed trailing end shielding the connector element. The passageway can transition from a first, open configuration to a second, closed configuration. In the open configuration, a shape of the passageway is altered to receive a connector element of a lead. In the closed configuration, the shape of the passageway is altered to secure the connector element therein.
Features discussed herein will be appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like numbered reference numbers designate like parts throughout the figures thereof, and wherein:
The various embodiments of touch-proof connectors described herein may be employed to reliably attach with and fully enclose the connector element(s) located outside a patient's body of a temporary medical lead that extends percutaneously through the patient's skin so as to shield and insulate the connector element(s). The temporary medical lead and the external medical device includes those used for nerve, muscle, brain or cardiac stimulation and/or monitoring. In this regard, the following terms have the particular meanings and definitions applicable to the specification and claims as set forth below.
The term “temporary medical lead” and any substantially similar variants thereof means an electrical signal and/or stimulation energy conducting lead that has a proximal end having at least one lead connector element and a break-away needle attached thereto, an elongated lead body, and one or more electrode in a distal end section of the lead body. The electrode(s) is adapted to be implanted at a monitoring and/or stimulation site in a patient's body while the lead body extends through the patient's skin, and the lead connector element is adapted to be coupled with a temporary touch-proof connector.
The terms “temporary heart wire”, “temporary heart lead” and any substantially similar variants thereof mean a temporary medical lead introduced surgically through the epicardium into the myocardium from the exterior of the heart, where the lead or wire has at least one electrode near its distal end for monitoring, pacing or defibrillating the heart at or near a myocardial or epicardial site, and where the lead or wire has at least one connector element coupled with the break-away needle at its proximal end for electrical connection to an external pacing, monitoring, or defibrillating apparatus. “The terms “heart wire,” “heart lead” and any substantially similar variants thereof are synonymous.
The term “proximal” means that portion of an apparatus, or component or element of an apparatus, disposed in closer proximity to the end of the temporary medical lead remaining outside a patient's body following the lead implantation procedure than it is to the distal end of the heart wire implanted in the patient's body.
The term “distal” means that portion of an apparatus, or component or element of an apparatus, disposed in closer proximity to the end of the temporary medical lead that is implanted in the patient's body, e.g., the distal electrodes and retention coil of a heart wire in the myocardium, than it is to the proximal end that remains outside the patient's body following the lead implantation procedure.
For simplicity of illustration, the temporary touch-proof connector embodiments are disclosed in detail in relation to use with temporary heart wires or nerve stimulation wires having bipolar, in-line connector elements attached to the proximally extending break-away needle. As will be apparent, the temporary touch-proof connector embodiments can be employed with temporary unipolar or bipolar heart wires or nerve stimulation wires having only a single connector element attached to the proximally extending break-away needle. Similarly, the temporary touch-proof connector embodiments can be modified to be employed with temporary multi-polar heart wires or nerve, organ or muscle stimulation and monitoring wires having more than two in-line connector elements attached to the proximally extending break-away needle.
Temporary medical lead or wire 10 preferably comprises break-away percutaneous penetrating needle 12, weakened zone 18, a proximal end segment 30 comprising proximal and distal lead connector elements 32 and 34, elongated lead body 70 enclosing first and second conductors, a distal end segment comprising proximal electrode 50, distal electrode 40, retention coil 60, and strand 80, and an atraumatic curved needle 90. It should be noted that the proximal lead connector element 32 may in fact be formed of a distal portion of the break-away needle shaft distal to the weakened zone 18 as shown in the '957 patent. The temporary touch-proof connector embodiments discussed herein enclose at least a portion of the proximal end segment 30, and in particular connector elements 32 and 34.
Strand 80, preferably formed of polypropylene and constituting a monofilament, forms retention coil 60, attaches to distal electrode 40 and extends to atraumatic curved needle 90. Retention coil 60 ensures secure temporary fixation of the distal electrodes of heart wire 10 in the heart and prevents dislodgment which might otherwise occur were a straight tipped lead employed. Most preferably, one length of polypropylene comprises coil 60 and strand 80. More than one curved needle 90 may be attached to distal end segment 20 of lead 10. For example, the lead body 70 may be bifurcated in distal end segment 20 such that each conductor of lead body 70 terminates in a separate pace/sense electrode, retention coil, and curved needle attached thereto.
Lead body 70 most preferably comprises conductors that provide a high degree of flexibility and superior mechanical and electrical properties. Lead body 70 may comprise any pair of suitable flexible electrical conductors, such as coaxial conductors or so-called “lamp cord” or “zip-cord” (e.g., side-by-side) conductors. Most preferably, lead body 70 is a coaxial pair of inner and outer electrical conductors, where the conductors are formed of helically wound strands of multifilament or twisted stainless steel. As discussed above, lead body 70 is insulated with a polyethylene, polytetrafluoroethylene, silicone, nylon, or other suitable electrically non-conductive and bi-compatible materials to insulate wires from one another and from the environment.
Electrodes 40 and 50 are preferably formed of medical grade stainless steel suitable for temporary applications, and are preferably spaced a predetermined distance apart known to optimize the delivery of pacing pulses or the detection and sensing of cardiac electrical signals. Distal electrode 40 is mechanically and electrically connected through the inner conductor (not shown in
In-line connector elements 32 and 34 are preferably formed of cylindrically shaped, conductive metal rings that are each electrically connected to a conductor of the lead body 70 and have a circular cross-section and diameter substantially equal to or slightly larger than the diameter of lead body 70. Other structural configurations of connector elements 32 and 34 can be employed with the temporary touch-proof connectors described herein and include, but are not limited to, pin-shaped connectors having rectangular or square cross-sections, reed-shaped connectors, and flexible connectors.
Needle 12, most preferably of the atraumatic type, is a break-away Keith-type needle for piercing the thorax, and has pointed end 16 and blunt end 14. Needle 12 is preferably substantially straight between pointed end 16 and blunt end 14. Pointed end 16 has a cutting edge designed for piercing the thoracic wall of the patient. Preferably, the weakened zone 18 separates the proximal end of proximal connector element 32 from blunt end 14. Or, the proximal connector element 32 may be the part of the break-away needle shaft distal to the weakened zone 18. The weakened zone 18 typically is a narrowed section or a heat treated junction of the needle shaft and the proximal end of the proximal connector element 18.
In relation to
In addition to serving as a device to prevent undesired electrical current or static electricity from passing through a lead to a patient's body during use of the lead, embodiments of the temporary touch proof connectors disclosed herein can also serve as a carrier for leads during packaging and distribution. As leads come into contact with a patient's body during use, it is important that the leads are maintained in sterile packaging prior to use. In some instances, needles (e.g., needle 12 and/or needle 90) can inadvertently puncture or tear the sterile packaging during distribution (e.g., shipping) of the lead. In such a case, the lead must be discarded or re-sterilized. When used as a packaging carrier, the temporary touch-proof connectors described herein can secure and protect needles of the leads from puncturing or tearing the lead packaging.
Leading end 104 defines an opening 112 for receiving a connector element. Opening 112 is open to an elongated passageway 114 (
In configuration 114′, passageway 114 includes a minor axis that is sized to be smaller than a diameter of connector element 32. By compressing sides 108 and 110, the minor axis size increases to a size greater than the diameter of connector element 32, allowing the connector element 32 to be easily inserted into passageway 114. After releasing compression from sides 108 and 110, the minor axis is biased to return to the smaller size and thus securing connector element 32 therein. In one embodiment, raised ridges 120 are disposed on top and bottom surface of connector body 102 so as to form the elliptical shape of passageway 114 and aid in changing the shape of passageway 114 when connector body 102 is compressed between sides 108 and 110.
With reference to
Passageway 181 is formed of a first passageway segment 194 and a second passageway segment 196. Receiving portion 182 maintains first passageway segment 194 and locking portion maintains second passageway segment 196. During use, locking portion 184 is depressed such that first passageway segment 194 is aligned with second passageway segment 196 (as shown in
When used as a carrier during packaging and distribution, touch-proof connector 250 includes internal passageways 290 and 292 that are configured to receive needles (e.g., needle 12) therein. As such, these needles will be protected during packaging and distribution. Additionally, connector 250 includes a first lower passageway 294 and a second lower passageway 296, configured to secure atraumatic curved needles (e.g., needle 90) therein. In the embodiment illustrated, passageways 294 and 296 are oriented generally perpendicular to passageways 258 and 260, when connector 250 is in the open configuration shown in
Passageway 294 includes a first passageway segment 298 configured to be aligned with a second passageway segment 300. Passageway segment 298 is formed in a locking portion 301 that is connected to connector body through a flexing portion 302. During packaging, locking portion 301 can be actuated such that passageway segments 298 and 300 are aligned, as shown in
As illustrated in
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/307,173 filed on Feb. 23, 2010, which is incorporated herein by reference.
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| Number | Date | Country | |
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| 61307173 | Feb 2010 | US |
