System and method for noninvasively altering the function of an implanted pacemaker
First Claim
1. A system for nonivasively altering the function of an implantable pacemaker by an external programmer, comprising:
- an implantable pacemaker comprising;
pulse generator means for providing stimulation pulses,control means for controlling the pulse generator means in accordance with a basic operating mode,a memory device,processor means for conditioning the operation of the pacemaker in accordance with a first control program stored in the memory device, said first control program comprising program instructions for controlling the processor means, and control parameters for specifying at least one function carried out by said implantable pacemaker, andtelemetry means coupled to the processor means and memory device for transferring program instructions and control parameters to the memory device from the external programmer;
an external programmer comprising;
means for establishing a telecommunicative channel between the telemetry means of said implantable pacemaker and said external programmer through which selected control parameters associated with said first control program may be selectively changed;
means for verifying at the external programmer the type of implantable pacemaker with which the telecommunicative channel has been established, and for verifying that the first control program stored in the memory device of said implantable pacemaker is one that is to be replaced; and
means for downloading a second control program from said external programmer to the memory device of said implantable pacemaker while the pulse generator means of said implantable pacemaker continues to operate in said basic operating mode as controlled by said control means, said second control program comprising new program instructions and control parameters for controlling the processor means so that an altered function is carried out by said implantable pacemaker, the second control program replacing said first control program, whereby at least one function carried out by said implantable pacemaker may be noninvasively altered during the same time that said implantable pacemaker continues to operate in said basic operating mode.
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Accused Products
Abstract
A system and method for safely altering the function of an implanted pacemaker in a noninvasive manner includes an implantable programmable pacemaker and a non-implantable programming device. The pacemaker includes a pulse generator that generates stimulation pulses as controlled by a control program. The control program, and associated control parameters, are stored in an implantable memory included within the pacemaker. The pacemaker further includes a telemetry circuit that allows the control parameters to be selectively changed or altered from a location remote from the pacemaker (i.e., a non-implanted location). The programmer includes a telemetry head for establishing a telemetry link with the pacemaker'"'"'s telemetry circuit. Once a telemetry link is established, the programmer may be selectively operated to download a new control program into the pacemaker memory, thereby replacing the old control program previously stored in the pacemaker memory. As the downloading of the new control program takes place (which may require several minutes), the pacemaker includes backup control circuits, or equivalent, for controlling the pulse generator so that stimulation pulses are provided, as needed, until the downloading operation has been successfully completed. In this manner, the control program of the implantable pacemaker is noninvasively updated without having to explant the pacemaker, and without having to cease operation of the pacemaker.
448 Citations
30 Claims
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1. A system for nonivasively altering the function of an implantable pacemaker by an external programmer, comprising:
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an implantable pacemaker comprising; pulse generator means for providing stimulation pulses, control means for controlling the pulse generator means in accordance with a basic operating mode, a memory device, processor means for conditioning the operation of the pacemaker in accordance with a first control program stored in the memory device, said first control program comprising program instructions for controlling the processor means, and control parameters for specifying at least one function carried out by said implantable pacemaker, and telemetry means coupled to the processor means and memory device for transferring program instructions and control parameters to the memory device from the external programmer; an external programmer comprising; means for establishing a telecommunicative channel between the telemetry means of said implantable pacemaker and said external programmer through which selected control parameters associated with said first control program may be selectively changed; means for verifying at the external programmer the type of implantable pacemaker with which the telecommunicative channel has been established, and for verifying that the first control program stored in the memory device of said implantable pacemaker is one that is to be replaced; and means for downloading a second control program from said external programmer to the memory device of said implantable pacemaker while the pulse generator means of said implantable pacemaker continues to operate in said basic operating mode as controlled by said control means, said second control program comprising new program instructions and control parameters for controlling the processor means so that an altered function is carried out by said implantable pacemaker, the second control program replacing said first control program, whereby at least one function carried out by said implantable pacemaker may be noninvasively altered during the same time that said implantable pacemaker continues to operate in said basic operating mode. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A system for noninvasively altering the function of an implantable pacemaker by an external programmer, comprising:
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an implantable pacemaker comprising; pulse generator means for providing stimulation pulses, control means for controlling the pulse generator means in accordance with a basic operating mode, a memory device, processor means for conditioning the operation of the pacemaker in accordance with a first control program stored in the memory device, said first control program comprising program instructions for controlling the processor means, and control parameters for specifying at least one function carried out by said implantable pacemaker, and telemetry means coupled to the processor means and memory device for transferring program instructions and control parameters to the memory device from an external location; an external programmer having means for establishing a telecommunicative channel between the telemetry means of said implantable pacemaker and said external programmer through which selected control parameters associated with said first control program may be selectively changed; means for verifying at the external programmer that the first control program stored in the memory device of said implantable pacemaker is one that is to be replaced; and means for downloading a second control program from said external programmer to the memory device of said implantable pacemaker through said telecommunicative channel, said second control program being stored in said memory device so as to replace said first control program. - View Dependent Claims (9, 10, 11, 12)
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13. A method for noninvasively altering the function of an implantable pacemaker while said pacemaker continues to perform a basic pacing function of providing stimulation pulses to a patient'"'"'s heart in a prescribed manner, said implantable pacemaker having a processor, a memory, means for establishing a telecommunicative channel with said pacemaker, and control means for controlling the functions carried out by said pacemaker in accordance with an existing control program and control parameters stored in the memory included within said pacemaker, said control program and control parameters being downloadable through said telecommunicative channel for storage in said memory, said method comprising the steps of:
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(a) establishing a telecommunicative channel with said implantable pacemaker from a non-implanted, remote location; (b) verifying through said telecommunicative channel that the existing control program is one that is to be replaced; (c) controlling said implantable pacemaker through said established telecommunicative channel to provide stimulation pulses in a prescribed manner without relying on the existing control program stored in said memory; (d) downloading a new control program through said established telecommunicative channel from said remote location and storing said new control program in said memory of said implantable pacemaker so as to replace said existing control program, said new control program being adapted to alter the functions the implantable pacemaker carries out;
said implantable pacemaker continuing to provide stimulation pulses to the patient'"'"'s heart in the prescribed manner while the new control program is being downloaded and stored in said memory;(e) controlling said implantable pacemaker through said established telecommunicative channel to execute new pacing functions in accordance with the new control program downloaded to and stored in said memory. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A pacing system comprising:
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an implantable pacemaker having pulse generator means for generating stimulation pulses and delivering said stimulation pulses to a patient'"'"'s heart, a memory wherein a control program may be stored, telemetry means for transferring control programs to the memory from an external location, and control means for controlling the pulse generator means in accordance with a prescribed mode of operation, said prescribed mode of operation being dependent at least in part upon the control program stored in the memory included within said implantable pacemaker; said control program having a first portion for controlling operation of the pulse generator means when operating in a rate-responsive mode, and a second portion for controlling operation of the pulse generator means when operating in a non-rate-responsive mode; an external programmer having means for establishing a telemetry link with the telemetry means of said implantable pacemaker; verification means at the external programmer for verifying through the telemetry link which of a plurality of control programs are stored in the memory of the implantable pacemaker; and reprogramming means at the external programmer and operable through said telemetry link for noninvasively altering a selected one of said first portion or said second portion of said control program stored in the memory of said implantable pacemaker.
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24. A system for noninvasively altering the function of an implantable medical device by an external programmer, comprising:
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an implantable medical device comprising; first means for providing a specified medical function; a memory device; processor means for controlling the operation of the first means of the implantable medical device in accordance with a first control program stored in the memory device; and telemetry means for receiving externally generated signals; an external programmer having means for establishing a communication link with the telemetry means of said implantable device; verification means at the external programmer for verifying through the communication link which of a plurality of control programs are stored in the memory of the implantable pacemaker; means for downloading a second control program from said external programmer through said communication link and storing said second control program within the memory device of said medical device, said downloading means storing said second control program in a memory location of said memory device not occupied by said first control program; and second means, coupled to said telemetry means, for controlling the operation of the first means of the implantable medical device in accordance with said second control program whenever a prescribed externally generated signal is received through said telemetry means. - View Dependent Claims (25, 26, 27, 28, 29, 30)
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Specification