US20090226328A1 - Remote Data Monitor For Heart Pump System - Google Patents

Remote Data Monitor For Heart Pump System Download PDF

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Publication number
US20090226328A1
US20090226328A1 US11/720,023 US72002305A US2009226328A1 US 20090226328 A1 US20090226328 A1 US 20090226328A1 US 72002305 A US72002305 A US 72002305A US 2009226328 A1 US2009226328 A1 US 2009226328A1
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United States
Prior art keywords
pump
controller
module
monitor
monitor module
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/720,023
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English (en)
Inventor
Gino F. Morello
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiodyme Inc
Original Assignee
MicroMed Technology Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by MicroMed Technology Inc filed Critical MicroMed Technology Inc
Priority to US11/720,023 priority Critical patent/US20090226328A1/en
Publication of US20090226328A1 publication Critical patent/US20090226328A1/en
Assigned to MICROMED TECHNOLOGY, INC. reassignment MICROMED TECHNOLOGY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MORELLO, GINO F.
Assigned to RELIANT HEART, INC. reassignment RELIANT HEART, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MICROMED TECHNOLOGY, INC.
Assigned to RELIANTHEART INC. reassignment RELIANTHEART INC. CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 033690 FRAME: 0320. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: MICROMED TECHNOLOGY, INC.
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/523—Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor speed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/585—User interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • the invention relates generally to heart pump systems and, more specifically, to a remote monitor for such pumps.
  • Implantable blood pump systems are generally employed either to completely replace a human heart that is not functioning properly, or to boost blood circulation in patients whose heart still functions but is not pumping blood at an adequate rate.
  • Known implantable blood pump systems are primarily used as a “bridge to transplant.”
  • existing blood pump system applications are mainly temporary fixes, intended to keep a patient alive until a donor is available.
  • the shortage of human organ donors, coupled with improvements in blood pump reliability make long-term, or even permanent blood pump implementations a reality.
  • Implantable pump systems have not been satisfactory for long term use.
  • Known systems of the continuous flow type are designed primarily for use in a hospital setting. These systems typically include the implanted pump device, a power source such as a rechargeable battery, a motor controller for operating the pump motor, and an external operator console. While some existing implantable pump systems allow for operation while decoupled from the operator console, operating these systems “stand-alone” can be a risky endeavor. This is due, at least in part, to the lack of an adequate user interface when the system is decoupled from the console.
  • prior blood pump systems are not conducive to long-term use outside an institutional setting.
  • Known systems often require a large, fixed operator console for the system to function. While prior art operator consoles may be cart mounted to be wheeled about the hospital, at home use of known systems is difficult at best.
  • Other problems of prior pump systems that have limited their mobility and use to relatively short times are related to motor controller size and shape limitations.
  • a pump control system includes a controller module for controlling a pump, such as an implantable blood pump.
  • a remote monitor is adapted to communicate with the controller module via a wireless communications medium, such as a low-power radio frequency link.
  • the remote monitor provides a user interface similar or identical to the controller module, providing a user the ability to remotely monitor the pump's performance and to respond to alarms.
  • FIG. 1 is a block diagram of a pump system in accordance with teachings of the present disclosure.
  • FIG. 2 illustrates an exemplary implantable heart pump in accordance with an embodiment of the system disclosed herein.
  • the VAD system 10 includes components designed to be implanted within a human body and components external to the body.
  • the components of the system 10 that are implantable include a pump 12 and a flow sensor 14 .
  • the external components include a portable controller module 16 and a remote monitor module 18 .
  • the implanted components are connected to the controller module 16 via a percutaneous cable.
  • the controller module 16 may be mounted to a support device, such as a user's belt 23 or to a vest worn by the user, for example. Additional components of a VAD system are shown and described in U.S. Pat. No. 6,183,412, which is incorporated by reference.
  • the controller module 16 includes a processor, such as a microcontroller 80 , which in one embodiment of the invention is a model PIC16C77 microcontroller manufactured by Microchip Technology.
  • the microcontroller 80 includes a multiple channel analogue to digital (A/D) converter, which receives indications of motor parameters from the motor controller 84 .
  • A/D analogue to digital
  • the controller module 16 may monitor parameters such as instantaneous motor current, the DC component or mean value of the motor current, and motor speed.
  • the embodiment shown in FIG. 1 further includes an integral flow meter 86 .
  • At least one flow sensor 14 is implanted down stream of the pump 12 .
  • a flow sensor 14 may be integrated with the pump 12 .
  • the flow meter 86 is coupled between the implanted flow sensor 14 and the microcontroller 80 .
  • the flow meter 86 receives data from the flow sensor 14 and outputs flow rate date to the microcontroller 80 , allowing the system to monitor instantaneous flow rate.
  • the VAD System 10 may incorporate an implantable continuous-flow blood pump, such as the various embodiments of axial flow pumps disclosed in U.S. Pat. No. 5,527,159 or in U.S. Pat. No. 5,947,892, both of which are incorporated herein by reference in their entirety.
  • An example of a blood pump suitable for use in an embodiment of the invention is illustrated in FIG. 2 .
  • the exemplary pump 12 includes a pump housing 32 , a diffuser 34 , a flow straightener 36 , and a brushless DC motor 38 , which includes a stator 40 and a rotor 42 .
  • the housing 32 includes a flow tube 44 having a blood flow path 46 therethrough, a blood inlet 48 , and a blood outlet 50 .
  • the stator 40 is attached to the pump housing 32 , is preferably located outside the flow tube 44 , and has a stator field winding 52 for producing a stator magnetic field.
  • the stator 40 includes three stator windings and may be three phase “Y” or “Delta” wound.
  • the rotor 42 is located within the flow tube 44 for rotation in response to the stator magnetic field, and includes an inducer 58 and an impeller 60 . Excitation current is applied to the stator windings 52 to generate a rotating magnetic field.
  • a plurality of magnets 62 are coupled to the rotor 42 . The magnets 62 , and thus the rotor 42 , follow the rotating magnetic field to produce rotary motion.
  • the remote data monitor (RDM) 18 is a small portable handheld device that includes a processing device 112 and a user interface 110 that effectively replicates the user interface 111 of the controller module 16 remotely via a wireless communication link 120 .
  • the wireless link 120 is a low-power radio frequency (RF) link usable over a maximum distance of approximately 300 feet (100 meters) using the system's standard antenna configuration. While in use, the device provides the user with the ability to remotely monitor the VAD pump's 12 performance and to respond to alarms.
  • the pump controller 16 and remote monitor(s) 18 may be programmed via the clinical data acquisition system or the remote monitor 18 may be programmed telemetrically by the pump controller 16 , for example.
  • the wireless link 120 includes antennas, which my suitably comprise simple monopoles.
  • the system's antennas maybe constructed from ferrite rods or with traces on the system's internal printed circuit board. Integral antennas may be used exclusively, or external antennas may be employed for increased range capability, or a combination of integral and external antennas may be used.
  • the integrity of the link 120 will be continuously verified while the device is in operation.
  • the remote monitor 18 In the event that the remote monitor 18 is located too far from the VAD controller 16 , the RF link becomes “noisy” or unusable, or if the monitor's 18 batteries are low, the VAD controller 16 will continue to function and alarm normally. More specifically, in exemplary implementations, the remote monitor 18 periodically transmits status information back to the pump controller 16 to conform proper link operation.
  • the remote monitor 18 may monitor and display received signal strength information, and the pump controller 16 can increase or decrease its transmitter output power proportional to the signal strength reported back from the remote monitor 18 .
  • the carrier may be angle modulated (i.e. frequency modulated (FM) or phase modulated (PM)) to minimize the effects of external noise induced errors.
  • the carrier may be amplitude modulated (AM) to maximize battery life.
  • Forward error correction techniques may be used to maximize the integrity of the communication link.
  • Spread spectrum techniques are used to further minimize externally induced noise from compromising the communication link between the pump controller and corresponding remote monitor.
  • the receiver may request that a transmission be retransmitted in the event of an error. In typical installations, transmissions are within the US and European ISM (i.e. Industrial, Scientific, Medical) band.
  • Each pump controller 16 and corresponding remote monitor 18 may communicate on a designated frequency or frequency pair or on the same frequency or frequency pair. Transmitted data packets contain the address of the intended remote monitor 16 .
  • Each pump controller 16 first “listens” to confirm if another pump controller 16 is transmitting. In the event there is no other transmission, the pump controller 16 may begin transmitting and, conversely, in the event another transmission is “heard” the pump controller 16 will wait for the channel to be clear. In other implementations, one pump controller 16 may broadcast to several remote monitors 16 (e.g. one with the patient, one with the caregiver).
  • the data transmitted between the pump controller 16 and remote monitor 18 may be encoded such that the remote monitor 18 only responds to data transmitted with a unique address or to transmissions containing the correct address.
  • a hardware or software based correlator may be used to identify the address.
  • the remote monitor 18 is approximately 3 inches wide by 2 inches high by 1 inch thick, weighs less than 5 oz., includes a wrist-strap such that it may be worn by the caregiver or patient on the wrist, and includes a combination belt clip/tilt stand for use on the patient's or caregiver's belt or nightstand.
  • the device 18 may be powered from an internal rechargeable battery to be completely portable or it may be plugged into the ac mains using an optional power adapter. Additionally, the device 18 may be plugged into an automotive power outlet for continuous operation while on long trips in an automobile or airplane. The device 18 will support simultaneous charging of the internal battery while monitoring the VAD controller 16 (e.g. at night while patient and parent/caregiver are sleeping).
  • the remote monitor's 18 user interface is identical to the VAD controller 18 interface and includes a tricolor light emitting diode (LED) backlit graphic liquid crystal display (LCD) to display multi-lingual diagnostic and emergency messages, a sealed two-button keypad with tactile feedback and rim-embossing to silence alarms and scroll through diagnostic message displays, three bicolor LEDs indicating individual battery status and fail-safe mode operation, two distinct, variable pitch, variable loudness audible enunciators, and an optional audible voice output for diagnostic and emergency alarms.
  • LED light emitting diode
  • LCD liquid crystal display
  • the audible alarms may be elicited through piezo buzzer enunciators.
  • the variable loudness audible enunciators maybe be operated such that the pitch and/or volume changes proportionally to the length of time that the alarm is activated.
  • the audible voice output may be elicited through a voice coil type speaker element.
  • a natural language speech synthesizer may be employed, including a phoneme based speech synthesizer enabling audible speech to be generated in a multiplicity of languages. Further, the natural language voice's pitch and cadence may be programmed to simulate a male or female adult voice based on the patient or caregiver's preference.
  • the natural language voice output's pitch and cadence may be programmed to simulate a less-intimidating child's voice for pediatric cases.
  • a motor with integral eccentric may be enabled to vibrate during any alarming condition to help in alerting the patient or caregiver.
  • a wireless audio channel may be added to integrate the functionality of a commercial “baby monitor” into the system.
  • a transmitter with a microphone or other sound detecting device transmits audio signals to a receiver integrated into the remote monitor 18 , which further includes an output device such as a speaker.
  • This function would also include a volume control to allow the parent or caregiver to set the device's output to the desired audio level.
US11/720,023 2004-11-16 2005-11-16 Remote Data Monitor For Heart Pump System Abandoned US20090226328A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/720,023 US20090226328A1 (en) 2004-11-16 2005-11-16 Remote Data Monitor For Heart Pump System

Applications Claiming Priority (3)

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US52287404P 2004-11-16 2004-11-16
US11/720,023 US20090226328A1 (en) 2004-11-16 2005-11-16 Remote Data Monitor For Heart Pump System
PCT/US2005/041743 WO2006055745A2 (en) 2004-11-16 2005-11-16 Remote data monitor for heart pump system

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US20090226328A1 true US20090226328A1 (en) 2009-09-10

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US (1) US20090226328A1 (ja)
EP (1) EP1812094B1 (ja)
JP (1) JP2008520285A (ja)
CN (1) CN101056663B (ja)
AT (1) ATE520429T1 (ja)
WO (1) WO2006055745A2 (ja)

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