Preserving patient specific data in implantable pulse...

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

Reexamination Certificate

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Reexamination Certificate

active

06285909

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to medical devices and more particularly to medical devices for preserving patient specific data programmed into and/or acquired by an implantable pulse generator.
BACKGROUND
Implantable pulse generators, such as implantable cardiac defibrillators (ICDs) and cardiac pacemakers, have evolved from basic to sophisticated electronic devices. As these implantable pulse generators evolve, the amount of cardiac data and information these devices store and rely upon to operate continues to increase. Cardiac data stored and acquired by implantable pulse generators include basic programmable values to patient specific cardiac data acquired over the life of the implantable pulse generator.
The typical life span of an implantable pulse generator range from 5 to 7 years. Factors that influence the life span of the implantable pulse generator include the size of the energy source, energy requirements for implementing the cardiac analysis algorithms of the implantable pulse generator, and how often the implantable pulse generator discharges electrical energy (e.g., how often an ICD discharges cardioversion pulses and/or defibrillation pulses). Once the energy source has been drained below a safe operating threshold, the implantable pulse generator is replaced. Implantable pulse generators are also replaced when post-operative complications (e.g., infection) arise after implantation.
Prior to being implanted into the patient, the replacement implantable pulse generator is programmed using a medical device programmer. The medical device programmer is used to establish a telemetric link with the implantable pulse generator after which programming instructions, including programmable operating values, are sent to control circuitry within the implantable pulse generator. In many cases, the programming instructions provided to the replacement implantable pulse generator are similar, if not identical, to the programming instructions that are already contained in the implantable pulse generator being replaced. Additionally, the implantable pulse generator being replaced may also contain patient-specific cardiac information, or data, that has been acquired during the life of the implantable pulse generator. Often times, this cardiac information could be useful to the replacement implantable pulse generator. Unfortunately, when the implantable pulse generator is replaced, the cardiac data contained in the implantable pulse generator is lost.
For the reasons stated above, and for other reasons stated below which will become apparent to those skilled in the art upon reading and understanding the present specification, there exists a need for preserving patient specific data stored in replaced implantable pulse generators.
SUMMARY OF THE INVENTION
The present subject matter provides a system and a method for reliably and conveniently preserving patient specific data stored in a replaced implantable pulse generator. The present subject matter allows for electronic data acquired and stored in the implantable pulse generator to be transferred to a replacement implantable pulse generator. By transferring the electronic cardiac data from one pulse generator to a replacement pulse generator, the replacement pulse generator benefits the patient by being programmed with cardiac data that has been acquired over the previous pulse generator's life. By not having to reacquire this data, the replacement pulse generator can utilize the established cardiac data by providing a more responsive and complete therapy to the patient. Finally, because many of the programmable values in the replacement pulse generator are identical in the pulse generator being replaced, the physician saves time by not having to enter this data into the replacement device.
The present subject matter allows for a communication link to be established with a first implantable pulse generator. Once the link has been established, electronic cardiac data stored in the pulse generator is retrieved through the communication link. The electronic cardiac data is then electronically downloaded to a second implantable pulse generator.
The present subject matter allows for the electronic cardiac data to be transferred between the first implantable pulse generator and the second pulse generator in several ways. For example, the electronic cardiac data is first downloaded, or transferred, from the first implantable pulse generator to a medical device programmer. The electronic cardiac data is then transferred from the medical device programmer to the second implantable pulse generator. In one embodiment, the transmission of the electronic cardiac data is done over a telemetric communication link established between the medical device programmer and the implantable pulse generator.
In an additional embodiment, after the electronic cardiac data has been downloaded from the first implantable pulse generator, the data is electronically processed in the medical device programmer into a format compatible with the second implantable pulse generator. The electronic cardiac data is then transmitted to the second implantable pulse generator.
Transfer of electronic cardiac data between any combination of the first implantable pulse generator, the second implantable pulse generator and the medical device programmer can also be accomplished using direct electrical connection between the circuitry within the devices. In one embodiment, the devices are coupled together through the use of connector lead(s) which establish an electrical connection between the devices and thus a higher-speed for transferring the data. The electronic cardiac data is then electronically downloaded from the first implantable pulse generator to the medical device programmer, and/or from the medical device programmer to the second implantable pulse generator by directly transferring the electronic cardiac data across the electrical connection. The cardiac data is then transferred through the use of at least one high-speed datalink.


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