U.S. patent application number 11/720023 was filed with the patent office on 2009-09-10 for remote data monitor for heart pump system.
This patent application is currently assigned to MicroMed Technology, Inc.. Invention is credited to Gino F. Morello.
Application Number | 20090226328 11/720023 |
Document ID | / |
Family ID | 36407759 |
Filed Date | 2009-09-10 |
United States Patent
Application |
20090226328 |
Kind Code |
A1 |
Morello; Gino F. |
September 10, 2009 |
Remote Data Monitor For Heart Pump System
Abstract
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 s
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.
Inventors: |
Morello; Gino F.; (Leonia,
NJ) |
Correspondence
Address: |
LOCKE LORD BISSELL & LIDDELL LLP;ATTN: IP DOCKETING
600 TRAVIS, SUITE 3400
HOUSTON
TX
77002-3095
US
|
Assignee: |
MicroMed Technology, Inc.
Houston
TX
|
Family ID: |
36407759 |
Appl. No.: |
11/720023 |
Filed: |
November 16, 2005 |
PCT Filed: |
November 16, 2005 |
PCT NO: |
PCT/US05/41743 |
371 Date: |
May 23, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60522874 |
Nov 16, 2004 |
|
|
|
Current U.S.
Class: |
417/1 ;
417/63 |
Current CPC
Class: |
A61M 60/148 20210101;
A61M 60/50 20210101; A61M 60/122 20210101; A61M 2205/3569 20130101;
A61M 2205/3334 20130101; A61M 60/82 20210101; A61M 2205/3592
20130101; A61M 2205/3331 20130101; A61M 60/205 20210101; A61M
60/422 20210101 |
Class at
Publication: |
417/1 ;
417/63 |
International
Class: |
F04B 49/00 20060101
F04B049/00 |
Claims
1. A pump control system comprising: a controller module
connectable to an implanted heart pump; and a monitor module
adapted to communicate with the controller module via a wireless
communications medium.
2. The pump control system of claim 1, wherein the controller
module includes: a processor; a motor controller electrically
coupled to the processor, the motor controller adapted to power the
pump motor such that the pump motor operates at a desired speed,
the motor controller adapted to output digital representations of
pump motor operating parameters to the processor; a user interface
coupled to the processor; and wherein the monitor module includes a
user interface.
3. The pump control system of claim 1, wherein the controller
module user interface matches the monitor module user
interface.
4. The pump control system of claim 1, wherein the wireless
communications medium is a bi-directional radio frequency (RF)
fink.
5. The pump control system of claim 1, wherein monitor module
includes a device for attaching to a user's wrist.
6. The pump control system of claim 1, wherein monitor module
includes a device for attaching to a user's belt.
7. The pump control system of claim 1, wherein monitor module
includes a device for receiving and outputting audio signals.
8. The pump control system of claim 1, wherein monitor module is
programmed to periodically transmit status information to the
controller module.
9. A method of operating a blood pump, comprising: connecting a
controller module to a blood pump; and transmitting data between a
monitor module and the controller module via a wireless
communications medium.
10. The method of claim 9, transmitting data includes transmitting
functional and alarm messages.
11. The method of claim 9, further comprising: powering the pump
such that the pump operates at a desired speed; outputting digital
representations of pump operating parameters on a user interface of
the controller module; transmitting the pump operating parameters
to the monitor module; and displaying the pump operating parameters
on a user interface of the monitor module.
12. The method of claim 9, wherein transmitting data includes
transmitting via a bi-directional radio frequency (RF) link.
13. The method of claim 9, further comprising: attaching the
monitor module to a user's wrist.
14. The method of claim 9, further comprising attaching the monitor
module to a user's belt.
15. The method of claim 9, further comprising transmitting status
information from the module to the controller module.
16. The method of claim 15, wherein transmitting status information
includes transmitting received signal strength information.
17. The method of claim 16, further comprising varying the transmit
output power of the controller module in response to the received
signal strength information.
18. The method of claim 9, wherein a plurality of controller
modules are connected to a plurality of corresponding blood pumps,
and wherein one monitor module communicates with the plurality of
controller modules.
19. The method of claim 9, wherein a plurality of controller
modules are connected to a plurality of corresponding blood pumps,
and wherein each of the controller modules communicates with a
corresponding monitor module on a predetermined frequency.
20. The method of claim 19, wherein data transmitted from the
controller module includes the address of the intended monitor
module.
21. The method of claim 9, wherein a plurality of monitor modules
communicate with a single controller module.
22. The method of claim 9, wherein the controller module verifies
that no other controller module is transmitting before transmitting
data to the monitor module.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 60/522,874, entitled "REMOTE DATA MONITOR
FOR HEART PUMP SYSTEM," filed on Nov. 16, 2004, which is
incorporated by reference.
BACKGROUND
[0002] The invention relates generally to heart pump systems and,
more specifically, to a remote monitor for such pumps.
[0003] 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." In other words, existing blood pump system
applications are mainly temporary fixes, intended to keep a patient
alive until a donor is available. However, the shortage of human
organ donors, coupled with improvements in blood pump reliability
make long-term, or even permanent blood pump implementations a
reality.
[0004] Despite this need, existing 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.
[0005] Moreover, 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.
[0006] Thus, there is a need for a pump control system that
addresses the shortcomings associated with the prior art.
SUMMARY
[0007] In accordance with certain teachings of the present
disclosure, 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Other objects and advantages of the invention will become
apparent upon reading the following detailed description and upon
reference to the drawings in which:
[0009] FIG. 1 is a block diagram of a pump system in accordance
with teachings of the present disclosure.
[0010] FIG. 2 illustrates an exemplary implantable heart pump in
accordance with an embodiment of the system disclosed herein.
[0011] While the invention is susceptible to various modifications
and alternative forms, specific embodiments thereof have been shown
by way of example in the drawings and are herein described in
detail. It should be understood, however, that the description
herein of specific embodiments is not intended to limit the
invention to the particular forms disclosed, but on the contrary,
the intention is to cover all modifications, equivalents, and
alternatives falling within the spirit and scope of the invention
as defined by the appended claims.
DETAILED DESCRIPTION
[0012] Illustrative embodiments of the invention are described
below. In the interest of clarity, not all features of an actual
implementation are described in this specification. It will of
course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developers' specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure.
[0013] Turning to the figures, and in particular to FIG. 1, a
ventricle assist device (VAD) system 10 in accordance with an
embodiment of the present invention is illustrated. 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.
[0014] 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. Thus, 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.
[0015] 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. Alternately, 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.
[0016] 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.
[0017] 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. In one
embodiment, 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.
[0018] 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. In an exemplary embodiment, 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.
[0019] 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.
[0020] The integrity of the link 120 will be continuously verified
while the device is in operation. 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.
[0021] The carrier may be angle modulated (i.e. frequency modulated
(FM) or phase modulated (PM)) to minimize the effects of external
noise induced errors. Alternatively, 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.
[0022] Multiple controller 16 and remote monitor 18 pairs may be
used in close proximity to one another. 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).
[0023] 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.
[0024] In certain embodiments, 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).
[0025] 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.
[0026] The backlit LCD can indicate functional pump information to
the patient and/or caregiver, and in exemplary embodiments, the
backlight utilizes multiple colors to convey functional and alarm
information to the patient and caregiver (e.g. green=normal,
yellow-diagnostic alarm, red=emergency alarm).
[0027] 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. Still further, 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.
[0028] Optionally, in pediatric applications, 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 minimizes the number of
different systems the parent or caregiver must use and manage. 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.
[0029] The above description of exemplary embodiments of the
invention are made by way of example and not for purposes of
limitation. Many variations may be made to the embodiments and
methods disclosed herein without departing from the scope and
spirit of the present invention. The present invention is intended
to be limited only by the scope and spirit of the following
claims.
* * * * *