Surgery – Diagnostic testing
Reexamination Certificate
2001-01-22
2003-10-21
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
C604S890100, C604S891100, C604S065000
Reexamination Certificate
active
06635014
ABSTRACT:
FIELD OF THE DISCLOSURE
This invention relates generally to ambulatory medical systems that are capable of having their control software modified via telemetry including replacement of program code (i.e. algorithms) that control how variable parameters are utilized. Preferred embodiments relate to implantable infusion pumps and external devices for communicating therewith.
BACKGROUND
Various ambulatory medical devices have been proposed and a number of such devices are commercially available. These devices include implantable infusion pumps, externally carried infusion pumps, implantable pacemakers, implantable defibrillators, implantable neural stimulators, implantable physiological sensors, externally carried physiologic sensors, and the like.
Implantable infusion pumps are generally configured to accept infusion commands from an external communication device. These commands are used to set program variables that are used in defining the quantity and/or timing that is used in supplying a drug to the patient. These commands are however, typically, incapable of changing or updating the program code, i.e. algorithm(s), that utilizes these variables. As such, after manufacturing and more particularly after implantation, the operation of these devices is typically fixed and immutable with the exception of the operational variances allowed and required by a current set of values assigned to programmable variables within the device.
U.S. Pat. No. 5,360,437, entitled “Implantable Medical Device With Flexible Hardware Platform”, to Thompson proposes an implantable medical device, and most particularly a pacemaker, that includes a non-volatile ferroelectric random access read/write memory for storing microprocessor instructions that can be overwritten after the pacemaker is implanted so as to allow pacemaker functionality to be modified based on progressive or otherwise changing medical condition of the patient. The '437 patent is focused on a providing a memory device that is non-volatile and that is capable of being written to.
The '437 patent fails to address several considerations associated with reliable and safe modification of control software: (1) ensuring that newly downloaded program software was not corrupted during download, (2) ensuring that the software can be downloaded in a safe manner that does not allow inappropriate operation of the implantable device during download, (3) ensuring that the downloaded software does not inadvertently overwrite any program that is associated with continued and reliable operation of the communications between the implantable device and the external communication device, (4) ensuring that upon system reset the device can be restarted in a safe mode without restarting operation of the medically active functions of the implantable device that may have become corrupted and could be dangerous to a patient, and (5) ensuring that newly downloaded software is not incompatible with any software that remains in the implantable medical device.
As such, a need exists in the field for ambulatory (e.g. implantable) devices that can not only accept updated values for variables that impact operation of the device but that can also accept modifications to its program (i.e. set of control instructions or algorithms) in a way that is safe, maintains the predictability of the software operating on the implantable device and maintains the integrity of the communication operations even if the download involves corrupted software. As such a need continues to exist in the art for implantable medical devices and communicators having enhanced reliability, enhanced functionality, and and/or enhanced safety features.
SUMMARY
It is a first object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that newly downloaded program code was not corrupted during download.
It is a second object of the invention to provide an implantable medical device capable of receiving a software program by telemetry from an external communication device while ensuring that the downloaded program is received in a manner that does not allow inappropriate operation of the implantable device during the download.
It is a third object of the invention to provide an implantable medical device capable of receiving a software program by telemetry from an external communication device while ensuring that the downloaded code does not inadvertently overwrite any program code that is associated with continued and reliable operation of the communications between the implantable device and the external communication device.
It is a fourth object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that upon system reset the device is restarted in a safe mode without restarting operations of medically active functions.
It is a fifth object of the invention to provide an implantable medical device capable of receiving program code by telemetry from an external communication device while ensuring that newly downloaded software is not incompatible with any medically active software that remains in the implantable device.
Other objects and advantages of various aspects of the invention will be apparent to those of skill in the art upon review of the teachings herein. The various aspects of the invention set forth below as well as other aspects of the invention not specifically set forth below but ascertained from the teachings found herein, may address the above noted objects or other objects ascertained from the teachings herein individually or in various combinations. As such, it is intended that each aspect of the invention address at least one of the above noted objects or address some other object that will be apparent to one of skill in the art from a review of the teachings herein. It is not intended that all, or even a portion of these objects, necessarily be addressed by any single aspect of the invention even though that may be the case with regard to some aspects.
A first aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry system sends messages to or receives messages from the MD telemetry system, wherein the MD processor is software controlled, and wherein the medical device includes an infusion device that is programmable to provide controlled quantities of a drug to the body of a patient and is capable of being put into a state for receiving replacement software via the MD telemetry system.
A second aspect of the invention provides a medical system that includes (a) an ambulatory medical device (MD) that includes MD electronic control circuitry that further includes at least one MD telemetry system and at least one MD processor that controls, at least in part, operation of the MD telemetry system and operation of the medical device, wherein the medical device is configured to provide a treatment to a body of a patient or to monitor a selected state of the body; and (b) a communication device (CD) that includes CD electronic control circuitry that further includes at least one CD telemetry system and at least one CD processor that controls, at least in part, operation of the CD telemetry system and operation of the communication device, wherein the CD telemetry sy
Lebel Ronald J.
Shahmirian Varaz
Starkweather Timothy J.
Weiss Philip T.
Hindenburg Max F.
Mallari Patricia
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