Implantable medical device programming apparatus having an...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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Reexamination Certificate

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06411851

ABSTRACT:

THE FIELD OF THE INVENTION
The present invention relates to portable computer equipment for use with implantable medical devices (IMDs). More particularly, the invention relates to an IMD programmer with a storage compartment configured to store and protect auxiliary components and their associated cables.
BACKGROUND OF THE INVENTION
Implantable medical device systems known in the art comprises several components, including an implantable medical device such as a pacemaker, pacing and/or sensing leads (leads), and a programmer. The leads connect the implantable medical device to the heart of a patient. The programmer provides multiple functions, including (a) assessing lead performance during a pacemaking or defibrillator implantation, (b) programming the implantable medical device, and (c) receiving feedback information from the implantable medical device for use by a clinician or physician (operator). By measuring the electrical performance of a lead during an implant procedure, the programmer aids the operator to select an electrically appropriate site for the placement of the lead(s).
The programmer or programming apparatus is typically portable and generally includes a housing for containing the computer circuitry and other electronic components such as: a power source (e.g., a battery) or at least a cable for connecting the apparatus to a source of power; at least one means for accepting user input (e.g., an alpha-numeric keyboard, a “mouse”, or similar devices) and output means (e.g., a text and/or graphic display, a printer, or similar devices) for communicating information to the operator. Additionally, the programming apparatus normally includes one or more auxiliary components for assisting in programming of the implantable medical device. Examples of auxiliary components include a magnetic programming head used to establish a telemetry link between the implanted device and the programmer; patient ECG RF heads for obtaining a patient's surface ECG; a stylus used to interact with a touch screen associated with the programming apparatus; and similar devices. Each of the one or more auxiliary components interface with the computer circuitry via an associated flexible cable. The flexible cable allows the auxiliary component to be maneuvered by the operator to a location slightly spaced from the housing (e.g. in proximity with the patient), yet remain operatively coupled to the computer circuitry.
A programmer for non-invasively programming an implantable medical device, and in particular a cardiac pacemaker, is described in its various aspects in the following U.S. Patents to Hartlaub et al., each commonly assigned to the assignee of the present invention and each incorporated by reference herein: U.S. Pat. No. 4,250,884 entitled “Apparatus For And Method Of Programming The Minimum Energy Threshold For Pacing Pulses To Be Applied To A Patient's Heart”; U.S. Pat. No. 4,273,132 entitled “Digital Cardiac Pacemaker With Threshold Margin Check”; U.S. Pat. No. 4,273,133 entitled “Programmable Digital Cardiac Pacemaker With Means To Override Effects Of Read Switch Closure”; U.S. Pat. No. 4,233,985 entitled “Multi-Mode Programmable Digital Cardiac Pacemaker”; and U.S. Pat. No. 4,253,466 entitled “Temporary And Permanent Programmable Digital Cardiac Pacemaker”.
Aspects of the programming apparatus that is the subject of the foregoing Hartlaub et al. patents (hereinafter “the Hartlaub programming apparatus”) are also described in U.S. Pat. No. 4,208,008 to Smith entitled “Pacing Generator Programming Apparatus Including Error Detection Means” and in U.S. Pat. No. 4,236,524 to Powell et al., entitled “Programming Testing Apparatus”. The Smith '008 and Powell et al. '524 patents are also incorporated by reference herein.
A telemetry system for communicating information either in analog or digital form, between an implanted device and an external programming apparatus is disclosed in U.S. Pat. No. 4,374,382 to Markowitz entitled “Marker Channel Telemetry System For A Medical Device”, and in U.S. Pat. No. 4,556,063 to Thompson et al., entitled “Telemetry System For A Medical Device”. The Markowitz '382 and Thompson et al., '063 patents are commonly assigned to the assignee of the present invention and are both hereby incorporated by reference herein.
In some cases, a real-time electro cardiogram (ECG) signal may be transmitted from the implanted device to an external unit, so that the physician can monitor the patient's heart activity and the effects of pacing pulses thereon. A pacemaker system having such capability is described, for example, in U.S. Pat. No. RE. 32,361 to Duggen, entitled “Implantable Telemetry Transmission System for Analog and Digital Data”, assigned to the assignee of the present invention and incorporated by reference herein.
An example of a programming apparatus incorporating each of the above-features is described in U.S. Pat. No. 5,345,362 to Winkler, entitled “Portable Computer Apparatus With Articulating Display Panel”, assigned to the assignee of the present invention and incorporated by reference herein. The Winkler '362 patent describes a programming apparatus having three auxiliary components (i.e., magnetic programming head, stylus, and patient ECG heads) removably stored within a storage compartment formed by the housing. Each of these auxiliary components are operatively coupled to the computer circuitry by flexible cables (best shown in FIG. 9 of the Winkler '362 patent). When not in use, the auxiliary components are stored in the storage compartment, that in turn is enclosed by a separate cover. The storage compartment is sufficiently sized to receive each of the auxiliary components and associated cables. However, due to a relative stiffness and inherent shape of the cables, it is possible that, prior to closure of the cover, portions of one or more of the cables will extend outwardly from the storage compartment along one of the storage compartment's side walls. That is to say, while the cables are inherently flexible, due to a requisite thickness of the conductor cable and surrounding insulation layer, the cables are somewhat rigid and have a natural tendency to revert or unwind to a pre-imparted shape when forced into a small area, such as the storage compartment. Further, the cable(s) are relatively long. Thus, an operator attempting to force a number of relatively long, stiff cables into the storage compartment may not notice a cable section extending out of the storage compartment. As the cover associated with the storage compartment is subsequently closed, the cable(s) is “pinched” between the cover and the housing, likely damaging the cable. While the cable may not be entirely severed, a defect will be introduced into the center conductor, resulting in a break upon subsequent flexing of the cable. In addition, the defect may cause the center conductor to quickly heat during use, again leading to potential failure.
A related potential problem arises during use of the programming apparatus. As previously described, the auxiliary components are removed from the storage compartment, thereby extending the cable(s) across the storage compartment's side walls. With the cables extended, the operator may accidentally close the cover, “pinching” one or more of the cables.
Further, because the storage compartment normally does not include separate retaining assemblies, even when the auxiliary components and cables are properly placed, component damage may occur with transport of the programming apparatus. The auxiliary components are normally not secured within the storage compartment. As a result, movement of the programming apparatus may jar one or more of the auxiliary components, potentially causing damage.
SUMMARY OF THE INVENTION
The present invention overcomes the disadvantages and limitations of the prior art by providing a programming apparatus for use with an implantable medical device including a storage compartment configured to consistently maintain and protect cables associated wi

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