Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/372—Arrangements in connection with the implantation of stimulators
  • A61N1/37211—Means for communicating with stimulators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/372—Arrangements in connection with the implantation of stimulators
  • A61N1/37211—Means for communicating with stimulators
  • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
  • A61N1/37282—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by communication with experts in remote locations using a network

Definitions

• the present device relates generally to implantable cardiovascular medical devices and particularly, but not by way of limitation, to such a device that can diagnose patient health by periodically monitoring patient health and converting from a monitoring mode to a therapeutic mode upon sensing a cardiovascular event.
• the human heart When functioning properly, the human heart maintains its own intrinsic rhythm based on physiologically-generated electrical impulses. It is capable of pumping adequate blood throughout the body's circulatory system. Each complete cycle of drawing blood into the heart and expelling it is referred to as a cardiac cycle.
• cardiac arrhythmias Some people have abnormal cardiac rhythms, referred to as cardiac arrhythmias. Such arrhythmias result in diminished blood circulation.
• Arrhythmias can occur in the upper chambers of the heart - the atria, or the lower chambers of the heart - the ventricles.
• ventricular arrhythmias present the most serious health risk as they can lead to rapid death from the lack of circulation.
• Arrhythmias can be subdivided further into specific conditions of the heart that represent vastly different manifestations of abnormal cardiac rhythm. These conditions are bradycardia, or a slow heartbeat, and tachycardia, or a fast heart beat.
• pacemakers also referred to as pacers
• defibrillators The traditional use of a pacemaker is to treat a person with bradycardia. In other words, pacemakers help speed up the cardiac cycle of a person whose heart beats too slowly. Pacers accomplish this by delivering timed sequences of low energy electrical stimuli, called pace pulses, to the heart. Such stimuli are delivered via an intravascular lead wire or catheter (referred to as a "lead”) having one or more electrodes disposed in or about the heart. In comparison to a pacemaker, an implanted defibrillator applies a much stronger electrical stimulus to the heart.
• defibrillation countershock This is sometimes referred to as a defibrillation countershock, also referred to simply as a "shock.”
• the shock changes ventricular fibrillation to an organized ventricular rhythm or changes a very rapid and ineffective cardiac rhythm to a slower, more effective rhythm.
• Defibrillators help treat cardiac disorders that include ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter. These inefficient or too rapid heartbeats reduce the pumping efficiency of the heart and thereby diminish blood circulation.
• the countershock delivered by the defibrillator interrupts the tachyarrhythmia, allowing the heart to re-establish a normal rhythm for the efficient pumping of blood.
• Another mode of treating a cardiac arrhythmia uses drug therapy. Drugs are often effective at restoring normal heart rhythms. Modern implantable medical devices can be configured to release drugs through specialized leads or a pumping device. Steroids are commonly administered in this manner to suppress inflammation of the heart wall. However, with continuing advances in pharmaceutical research, powerful anti-arrhythmic drugs may also be administered through an implantable medical device.
• An implantable medical device also can be configured to include an accelerometer.
• a tiny crystal sensor inside the device detects body movement and signals the device to adjust pacing of the heart up or down according to the wearer's activity.
• This technology has been further refined so that modern implantable medical devices can mimic the heart's natural rhythm even more closely by adjusting the rhythm according to a person's activity level.
• Modern implantable medical devices also can separately sense and coordinate the contractility of both the upper (atria) and lower (ventricles) chambers of the heart and serve as dual pacer/defibrillators, drug delivery devices, and as a component of a comprehensive patient management system for predictive management of patients with chronic disease.
• Modern implantable medical devices are becoming smaller (1/2 the size) and smarter than earlier devices and can last much longer.
• a cardiovascular event within the context of the invention comprises an arrhythmic event.
• the convertible implantable medical device described herein comprises subsystems that perform specific functions. Those functions comprise a sensing function, a therapy function and a communications function. Each function can be selectively controlled by a separate control, or combined control and analysis module that opens and closes gated circuits.
• Gated circuit S controls an interactive sensing module that activates the sensing function.
• Gated circuit T controls an interactive therapy module that activates the therapy function
• gated circuit C controls an interactive communications module that activates the communications function.
• a gated circuit When a gated circuit is closed, it completes an electrical circuit with the power source and the module it controls and activates the function of that module.
• the device is configured to duty cycle from active (on) to inactive (off or dormant) states through the use of gated circuit S.
• the control and analysis module closes gated circuit S, the circuit is complete and the sensing module is activated to perform the sensing function.
• gated circuit S is open (off), the sensing module is inactive.
• a single duty cycle might be timed by gated circuit S being closed for 10 seconds out of every minute.
• the sensing module monitors and senses cardiovascular function.
• the device converts from monitoring mode to therapeutic mode.
• Therapy can comprise electrical stimulation or chemotherapy. Duty cycling the device in this manner conserves power without compromising patient health.
• the power demand on the battery is minimal.
• the dormant state interval is relatively short, a sustained or persistent cardiovascular event that is sensed when the sensing module is activated would likely be diagnosed and treated before it becomes life threatening.
• control and analysis module controls gated circuits S and T.
• gated circuit T When gated circuit T is closed (on), the circuit is complete and the therapy module is activated to perform the therapy function.
• gated circuit T When gated circuit T is open (off), the therapy module is inactive.
• gated circuit S can be permanently closed (on) to permanently activate the sensing module and function.
• the sensing module senses an actionable cardiovascular event
• gated circuit T switches on the therapy module temporarily.
• the device can serve as a defibrillator and post-detection guardian by allowing the device to respond instantly to an acute event like cardiac fibrillation, which is potentially life threatening.
• gated circuit S and the sensing module can again be permanently on to sense a cardiovascular event requiring intervention.
• gated circuit T and the therapy module is activated permanently and is available to provide continuous therapy.
• the device can serve as a pacer by allowing the device to provide continuous therapy for a chronic cardiac condition like bradycardia.
• the device comprises a control and analysis module, a sensing module, a therapy module and a communications module.
• the control and analysis module directs the closed and open states of gated circuits S, T and C, which in turn activate the sensing, therapy and communications modules respectively.
• the selective activation of the modules and their functions through the gated circuits controls the duty cycle of the device.
• gated circuit S when gated circuit S is closed, the sensing module is activated and monitors and senses patient health using predefined cardiovascular parameters. If the sensing module senses a cardiovascular event, it relays that information to the control and analysis module.
• the control and analysis module analyzes and diagnoses the cardiovascular event to determine if therapeutic intervention is necessary.
• the control and analysis module closes gated circuit T to activate the therapy module, which delivers an appropriate course of therapy.
• the control and analysis module may close gated circuit C, which activates the communications module.
• the communications module communicates the diagnosed and treated cardiovascular event to the control and analysis module to control further operation of the device and/or to a data accessible patient management system.
• Such communicated cardiovascular data may be used as data points in post-myocardial infarction randomized controlled trials (RCTs).
• the device has diagnostic and therapeutic functions and is powered by a battery adapted to power operation of the device for at least 7 years.
• Lithium-based batteries may be employed to satisfy the embodiment wherein the device is powered for at least 7 years.
• batteries comprising other than lithium may be employed to satisfy the embodiment wherein the device is powered for at least 7 years.
• the device also comprises an interactive control and analysis module adapted to analyze and . diagnose an arrhythmic cardiovascular event and selectively control a plurality of gated circuits S, T and C that turn the functions of the device on and off by closing and opening the gated circuits.
• the operation of the device can be duty cycled between active, partially active or inactive states to conserve power.
• the device is adapted to monitor and assess patient health within ranges of nominal to maximal vigilance.
• the interactive control and analysis module which is always active, is coupled to the interactive sensing module that is adapted to sense an arrhythmic cardiovascular event.
• the interactive control and analysis module also is coupled to the interactive therapy module adapted to deliver an appropriate course of therapy. Therapy can be in the form of electrical stimuli or chemotherapy or a combination of both.
• the interactive control and analysis module is further coupled to the interactive communications module that communicates data reflecting the sensed, analyzed and diagnosed arrhythmic cardiovascular event and delivered therapy to control further operation of the device.
• the interactive communications module also may communicate data reflecting a record of the diagnosed and treated cardiovascular event to an externally accessible patient management system.
• the device offers the most flexibility in controlling the diagnosis and treatment of a cardiovascular event in a prophylactic manner while simultaneously conserving battery power.
• Figure 1 is a schematic/block diagram illustrating generally, among other things, the modular subsystems of the convertible, implantable cardiovascular medical device with a controlled diagnostic function of the present invention.
• Figure 2 is a schematic/block diagram illustrating generally, among other things, another embodiment of the modular subsystems of the convertible, implantable cardiovascular medical device with a controlled diagnostic function of the present invention.
• Figure 3 is a schematic/block diagram illustrating generally, among other things, another embodiment of the convertible, implantable cardiovascular medical device with a controlled diagnostic function of the present invention.
• Figure 4 is a state diagram illustrating generally, among other things, the functions and activation sequences of the subsystems of the convertible, implantable cardiovascular medical device with a controlled diagnostic function of the present invention.
• Figure 5 is a schematic/olock diagram illustrating generally, among other things, another embodiment of the convertible, implantable cardiovascular medical device with a controlled diagnostic function of the present invention.
• the present method and device are described with respect to an implantable cardiovascular medical device that is adapted to periodically monitor patient health and convert from monitoring mode to therapeutic mode upon sensing a cardiovascular event requiring medical intervention.
• the device's diagnostic function is controlled and the therapy it provides is initially prophylactic.
• the periodicity of monitoring and/or providing therapy is referred to as a duty cycle.
• duty cycle or “duty cycling” refers to the process of configuring the device to successively cycle from active (on) to inactive (off or dormant) states as a way to effectively monitor patient health while simultaneously conserving battery power.
• the convertible, implantable medical device also can be integrated with an implantable cardiovascular medical device that is adapted to periodically monitor patient health and convert from monitoring mode to therapeutic mode upon sensing a cardiovascular event requiring medical intervention.
• the device's diagnostic function is controlled and the therapy it provides is initially prophylactic.
• the periodicity of monitoring and/or providing therapy is referred to as a duty cycle.
• duty cycle or “duty cycling” refers to the process of configuring the
• patient management refers to the process of creating and collecting patient specific information, storing and collating the information, and generating actionable recommendations to enable the predictive management of patients with chronic disease.
• gated or “gated circuit” refer to the process of gating an electrical circuit so said circuit can be selectively powered.
• Figure 1 is a schematic/block diagram illustrating generally the modular subsystems of a convertible, implantable medical device 100 having controlled diagnostic, therapeutic and communications functions.
• the device 100 is powered by a battery power source 101 adapted to power operation of the device for at least 7 years.
• a battery power source 101 may comprise a lithium-based battery.
• the device also comprises an interactive control and analysis module 102 adapted to analyze and diagnose an arrhythmic cardiovascular event.
• the arrhythmic cardiovascular event can be a bradycardic or tachycardic event and can be localized in either the atria or the ventricles or both.
• the interactive control and analysis module 102 also controls a plurality of duty cycles that successively turn the functions of the device on and off. The duty cycles can be triggered by fixed or variable parameters.
• a fixed duty cycle can be set by timing gated circuit S 103 to continuously cycle from active to inactive states in intervals less than 60 minutes.
• gated circuit S 103 may be closed for an interval of 5 seconds out of every minute - 5 seconds being roughly the time it takes for a human heart to complete 5 cardiac cycles.
• gated circuit S 103 also may be timed to duty cycle to the off state for no more than 30 seconds.
• sensing module 103 a detects a cardiovascular event requiring intervention, sensing module 103 a communicates with the interactive control and analysis module 102, which in turn closes gated circuit T 104 to activate therapy module 104a to deliver an appropriate course of therapy.
• the interactive control and analysis module 102 may close gated circuit C 105 to activate communications module 105a to communicate the sensed and analyzed cardiovascular event and delivered therapy data to the interactive control and analysis module 102 or an external system.
• gated circuit S 103 can be configured to continuously cycle from active to inactive states based on a number of cardiac cycles.
• the number of cardiac cycles that gated circuit S 103 is closed, thereby activating sensing module 103a can be 3 cardiac cycles.
• gated circuit S 103 is closed for a physiologically or technologically appropriate time interval.
• a technologically appropriate time may be the time it takes the control and analysis module 102 or other analytical component to analyze and recognize a cardiovascular event requiring therapeutic intervention.
• gated circuit S 103 when gated circuit S 103 is closed, it activates sensing module 103 a, which upon sensing a cardiovascular event requiring intervention, relays that information to the interactive control and analysis module 102, which in turn activates therapy module 104a by closing gated circuit T 104. As always, the interactive control and analysis module 102 may activate the communications module 105a by closing gated circuit C 105.
• a variable duty cycle of the therapeutic function might be accomplished by selectively controlling gated circuits S 103 and T 104.
• gated circuit S 103 is always closed to permanently activate sensing module 103a for detection of a cardiovascular event. If sensing module 103 a senses a cardiovascular event requiring intervention, it relays that information to the control and analysis module 102, which in turn closes gated circuit T 104 to activate therapy module 104a.
• gated circuit T 104 and therapy module 104a can be activated temporarily or permanently.
• gated circuit T 104 When gated circuit T 104 is temporarily closed, it temporarily activates therapy module 104a. Therapy module 104a is available to deliver appropriate therapy should sensing module 103 detect another cardiovascular event requiring intervention.
• the implantable medical device can serve as a defibrillator and a post-detection guardian against a subsequent, but temporally proximate cardiovascular event.
• therapy module 104a When gated circuit T 104 permanently activates therapy module 104a, therapy module 104a provides continuous therapy.
• the implantable medical device can serve as a pacer for treatment of post-implant heart block development or other chronic ailments requiring constant pacing of the heart.
• the interactive control and analysis module 102 may activate the communications module 105a by closing gated circuit C 105.
• Figure 2 is a schematic/block diagram illustrating generally, among other things, another embodiment of the modular subsystems of a convertible, implantable medical device 100 having controlled diagnostic, therapeutic and communications functions.
• the sensing module 103a not only performs the sensing function, but also the analysis function.
• Figure 3 is a schematic/block diagram illustrating generally an embodiment of a convertible, implantable medical device 100 having controlled diagnostic and therapeutic functions implanted within a patient 200.
• the device 100 is powered by a long-lasting battery power source 101 adapted to power operation of the device for at least 7 years.
• the implantable medical device 100 is adapted to electronically communicate 203 a record of a diagnosed cardiovascular event and delivered therapy to an external device like an Advanced Patient Management system 201 that is accessible by the patient 200 and/or a physician or other clinician 202.
• Advanced Patient Management system 201 that is accessible by the patient 200 and/or a physician or other clinician 202.
• electronic communication with the APM may be accomplished by the use of various wired or wireless technologies.
• FIG 4 is a state diagram illustrating generally, among other things, the functions and activation sequences of the subsystems of the convertible, implantable medical device 100 comprising a control and analysis function 102, a sensing function 103a, a therapeutic function 104a and a communications function 105a.
• the modules are coupled in such a manner that the specific functions of the modules can be selectively duty cycled to a variety of active and inactive states.
• the control and analysis module 102 controls the duty cycles and functions of the modules by selectively closing gated circuits S 103, T 104 and C 105 as shown in Figure 1.
• Gated circuit S 103 activates the sensing module 103a, which performs the sensing function.
• Gated circuit T 104 activates the therapy module 104a, which performs the function of delivering therapy.
• Gated circuit C 105 activates the communications module 105a, which performs the communications function.
• the sensing module 103a monitors and senses patient health using predefined cardiovascular parameters. Those parameters can be indexed against standard population data or customized according to a patient's 200 unique health profile. If the sensing module 103a senses a cardiovascular event, the control and analysis module 102 analyzes and diagnoses the event to determine if therapeutic intervention is necessary. If so, the device converts to therapeutic mode, and the control and analysis module activates the therapy module 104a for delivery of an appropriate course of therapy in the form of electrical stimulation or chemotherapy.
• the control and analysis module 102 may activate the communications module 105a to interactively communicate the diagnosed cardiovascular event and delivered therapy data to the control and analysis module 102, which combines data received from the communications module to control further operation of the device.
• the control and analysis module 102 or communications module 105a may also electronically communicate 203 the diagnosed cardiovascular event and delivered therapy to an external device like an Advanced Patient Management (APM) system 201 accessible by the patient 200 and/or the physician 202.
• APM Advanced Patient Management
• the device offers the most flexibility as both a duty cycled device and a device that can prophylactically treat a specific cardiovascular problem upon demand while simultaneously conserving power to extend the device's battery 101 life. By maximizing the duty cycling of the entire device or a specific function of the device, the battery 101 life can be extended to at least 7 years without having to replace the device. Thus, a patient 200 may have to go through the implantation procedure only once during a lifetime.
• FIG. 5 is a schematic/block diagram illustrating generally another embodiment of the convertible, implantable medical device 100 as a component of an APM system 201.
• APM is a system that helps patients, their physicians and their families to better monitor, predict and manage chronic diseases.
• APM is particularly useful in maintaining long-term data continuity and combining information from medical devices, including the device with a controlled diagnostic function disclosed herein, with patient information from other medical databases.
• the APM system 201 consists of three primary components: 1) a convertible, implantable medical device 100 including a sensing module 103 a adapted to monitor physiological functions, 2) a data management module 400 comprising a medical practice database, general practice data, patient data, and patient population data, that processes the data collected from the sensing module, and 3) analyzers 401 that analyzes data from the data management module 400.
• APM is designed to support physicians and other clinicians in using a variety of different devices, patient-specific and non-specific data, along with medication therapy, to provide the best possible care to patients.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
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• Electrotherapy Devices (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)

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• 2002
  • 2002-11-26 US US10/305,548 patent/US7333853B2/en not_active Expired - Fee Related
• 2003
  • 2003-11-25 JP JP2004555800A patent/JP4496084B2/ja not_active Expired - Fee Related
  • 2003-11-25 EP EP03787200A patent/EP1565233A2/en not_active Withdrawn
  • 2003-11-25 AU AU2003295985A patent/AU2003295985A1/en not_active Abandoned
  • 2003-11-25 WO PCT/US2003/037945 patent/WO2004047912A2/en not_active Ceased

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