Device programmer with enclosed imaging capability

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

Reexamination Certificate

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Details

C600S407000, C600S508000

Reexamination Certificate

active

06704600

ABSTRACT:

TECHNICAL FIELD
The present invention is directed to imaging systems and programmers for cardiac devices. More particularly, the present invention is directed to the combination of device programmers with imaging systems.
BACKGROUND
Cardiac devices, such as pacemakers and implantable cardiac defibrillators, have electrical leads that must be implanted within or onto the surface of the heart. The electrical leads may be used to detect electrical events occurring in the heart and to pass an electrical signal caused by the electrical event to the cardiac device. The electrical leads may also be used to provide electrical stimulation from the cardiac device to the heart tissue. The electrical stimulation causes contraction of the heart tissue. For example, electrical stimulation can be provided to the heart to vary the delay between the depolarization of the atrial area and depolarization of the ventricle area.
To properly install the electrical leads of the cardiac device, sophisticated imaging systems such as fluoroscopy are typically used to provide a high resolution X-ray of the patient's chest as the leads are being inserted. Generally, the sophisticated imaging systems are permanently located in electrophysiology or surgical rooms, and implantation of the device must occur at these locations.
In addition to the sophisticated imaging system, the physician employs a device programmer to adjust performance parameters of the implantable device. The programmer generally uses telemetry to send and receive signals, such as magnetic waves, to and from the implantable device. Thus, the physician uses the imaging system to view and position the electrical leads and to view the hemodynamic response of the heart. While viewing the leads and response, the physician also adjusts the operational parameters of the device with the programmer to alter the hemodynamic response.
Therefore, there is a need for a tool that allows installation of the leads in a less rigorous medical environment while simplifying the evaluation and optimization of device performance.
SUMMARY
The present invention addresses problems such as but not limited to those mentioned above by providing an electronic tool having a programmer system and an imaging system. A device programmer is typically portable and by combining an imaging system such as ultrasound with the programmer in the electronic tool, the implantation process may be performed in environments other than surgical labs. Furthermore, the tool provides a display that may show an image of the patient's heart including the electrical leads while simultaneously showing ordinary programmer information such as electrogram signals received from the implantable device. The tool may also provide a processor to analyze the image for lead position and hemodynamic response and may also analyze the electrogram signals. From this analysis, the tool may communicate signals to alter the device parameters and improve hemodynamic response.
The present invention may be viewed as an electronic tool for communicating with a heart stimulation device and for imaging a chest region of a patient. The tool includes an enclosure and an imaging device at least partially disposed within the enclosure. The imaging device radiates energy onto the chest region and detects energy reflected by the chest region to produce an image signal. The tool also includes a communication device at least partially disposed within the enclosure that sends to or receives from the heart stimulation device a first signal with encoded information.
The invention may be viewed as another electronic tool for communicating with a heart stimulation device and for imaging a chest region of a patient. The electronic tool includes an imaging device that radiates energy onto the chest region and that detects energy reflected by the chest region to produce an image signal. The tool includes a communication device that sends to or receives from the heart stimulation device a first signal with encoded information. At least one display screen is in electrical communication with the imaging device and the communication device, and the display screen displays a representation of the image signal or displays information from the first signal sent from or received by the communication device.
The present invention may be viewed as another electronic tool for communicating with a heart stimulation device and for imaging a chest region of a patient. The electronic tool includes an imaging device that radiates energy onto the chest region and that detects energy reflected by the chest region to produce an image signal. The tool includes a communication device that receives a first signal with encoded information from the heart stimulation device. At least one processing device is in electrical communication with the imaging device or the communication device, wherein the at least one processing device analyzes the image signal or analyzes the information encoded on the first signal to formulate an instruction for the heart stimulation device.
The present invention may be viewed as another electronic tool for communicating with a heart stimulation device and for imaging a chest region of a patient. The tool includes means for radiating energy onto the chest region and for detecting energy reflected by the chest region to produce an image signal. The tool includes means for radiating a first signal with encoded information onto the heart stimulation device. The tool also includes means for formulating the first signal based at least on the image signal.
The present invention may be viewed as a method of programming a heart stimulation device having one or more electrical leads placed in a heart of a patient. The method involves radiating energy onto an area around the heart of the patient and receiving energy reflected by the one or more electrical leads positioned in the heart. The method further involves producing an image signal representative of the received energy and analyzing, with a processing device, the image signal to measure motion of the electrical lead. The method also involves producing, with the processing device and in response to the measured motion of the electrical lead, a signal encoding instructions for varying stimulation one or more stimulation parameters of the heart stimulation device.
The present invention may be viewed as a method for positioning an electrical lead of a heart stimulation device in a heart of a patient. The method involves radiating, with an imaging device at least partially within a first enclosure, energy onto an area around the heart of the patient and receiving energy reflected by the electrical lead positioned in the heart. The method further involves producing an image signal representative of the received energy and involves receiving, with a communications device at least partially within the first enclosure, an activity signal radiated from the heart stimulation device. The method also involves displaying, on a display screen, a first representation of the image signal and a second representation of the activity signal.
The present invention may be viewed as an electronic tool for communicating with a heart stimulation device and for imaging a chest region of a patient. The electronic tool includes an imaging device that radiates energy onto the chest region and that detects energy reflected by the chest region to produce an image signal. The tool includes a communication device that radiates a first signal with encoded information to the heart stimulation device. The tool also includes at least one processing device in electrical communication with the imaging device and the communication device, wherein the at least one processing device analyzes the image signal to formulate an instruction for the heart stimulation device that is encoded onto the first signal.
The present invention may be viewed as a method of programming a heart stimulation device of a patient. The method involves radiating, with an imaging device, energy onto an area around the heart of the pat

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