U.S. patent application number 11/625879 was filed with the patent office on 2007-06-14 for patient monitoring apparatus and method for orthosis and other devices.
Invention is credited to Justin E. Beyers, Peter M. Bonutti.
Application Number | 20070135738 11/625879 |
Document ID | / |
Family ID | 33298763 |
Filed Date | 2007-06-14 |
United States Patent
Application |
20070135738 |
Kind Code |
A1 |
Bonutti; Peter M. ; et
al. |
June 14, 2007 |
PATIENT MONITORING APPARATUS AND METHOD FOR ORTHOSIS AND OTHER
DEVICES
Abstract
A monitoring system for monitoring a patient using a device,
such as all orthosis system is provided. The system includes a
monitor that can be incorporated or otherwise coupled to the
device. The monitor can have a position sensor, a temperature
sensor, and a device type sensor for monitoring the patient's
implementation of a protocol. The data obtained from the monitor
can be remotely analyzed by a healthcare professional and the
protocol can be adjusted accordingly.
Inventors: |
Bonutti; Peter M.;
(Effingham, IL) ; Beyers; Justin E.; (Chicago,
IL) |
Correspondence
Address: |
PAUL D. BIANCO: FLEIT, KAIN, GIBBONS,;GUTMAN, BONGINI, & BIANCO P.L.
21355 EAST DIXIE HIGHWAY
SUITE 115
MIAMI
FL
33180
US
|
Family ID: |
33298763 |
Appl. No.: |
11/625879 |
Filed: |
January 23, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10421965 |
Apr 23, 2003 |
7182738 |
|
|
11625879 |
Jan 23, 2007 |
|
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Current U.S.
Class: |
601/5 ; 601/23;
601/33; 601/DIG.19; 601/DIG.23 |
Current CPC
Class: |
A61B 5/0205 20130101;
A61B 5/021 20130101; A61B 5/0022 20130101; A61M 5/1723 20130101;
A61B 5/002 20130101; A61B 5/024 20130101; A61H 1/0277 20130101;
A61B 5/02055 20130101; Y10S 601/19 20130101; Y10S 601/23 20130101;
A61B 5/742 20130101; A61F 5/0102 20130101; A61B 5/681 20130101 |
Class at
Publication: |
601/005 ;
601/023; 601/033; 601/DIG.019; 601/DIG.023 |
International
Class: |
A61H 1/00 20060101
A61H001/00 |
Claims
1. A physical therapy apparatus comprising: a therapeutic device; a
plurality of sensors positionable on the therapeutic device; and a
patient monitor comprising a memory and operable between an
administrative mode, a treatment mode, and a data transfer mode,
wherein in the administrative and data transfer modes the patient
monitor is detachably connected to a computer, and in the treatment
mode the patient monitor is detachably connected to the plurality
of sensors.
2. A physical therapy apparatus as set forth in claim 1 wherein in
the administrative mode treatment parameters are stored in the
memory.
3. A physical therapy apparatus as set forth in claim 2 wherein in
the treatment mode the patient monitor controls an exercise session
according to the stored treatment parameters, and takes and stores
patient use data from the plurality of sensors in the memory.
4. A physical therapy apparatus as set forth in claim 3 wherein in
the treatment mode the patient monitor provides instructional steps
for completing the exercise session.
5. A physical therapy apparatus as set forth in claim 3 wherein in
the data transfer mode the stored patient use data from the
exercise session is downloaded to the computer.
6. A physical therapy apparatus as set forth in claim 5 further
comprising: an electronic device identifier connected to the
therapeutic device: and the plurality of sensors includes a device
sensor connected to the electronic device identifier, such that in
the treatment mode the device sensor identifies the treatment
parameters for the therapeutic device.
7. A physical therapy apparatus as set forth in claim 6 wherein in
the administrative mode a plurality of treatment parameters for a
plurality of therapeutic devices are stored in the memory.
8. A physical therapy apparatus as set forth in claim 5 wherein the
plurality of sensors includes a position sensor for measuring a
position of the therapeutic device.
9. A physical therapy apparatus as set forth in claim 8 wherein the
plurality of sensors includes a temperature sensor for determining
when the therapeutic device is being worn by a patient.
10. A physical therapy apparatus as set forth in claim 9 wherein
the patient monitor includes a timer for determining when a
predetermined time period has expired since the position sensor
detected a stopping of movement of the therapeutic device.
11. A physical therapy apparatus as set forth in claim 10 further
comprising a buzzer connected to the timer for generating a patient
detectable signal indicated the expiration of the predetermined
time period.
12. A physical therapy apparatus as set forth in claim 1 wherein
the therapeutic device is an orthosis device, an electrostimulation
device, a bone growth stimulation, a drug delivery system, a
cardiac rehabilitation; an insulin pumps for diabetics, a
medication pump, or a chemical sensor.
13. A physical therapy apparatus comprising: a therapeutic device;
a plurality of sensors positionable on the therapeutic device; a
patient monitor including an external memory and a data
communication interface, the patient monitor operable between an
administrative mode, a treatment mode, and a data transfer mode,
wherein in the treatment mode the plurality of sensors are
detachably connected to the data communications interface of the
patient monitor and a computer including application software for
processing patient use data from the external memory, the computer
being detachably connected to the data communications interface of
the patient monitor in the administrative and data transfer
modes,
14. The physical therapy apparatus as set forth in claim 13,
wherein the data communication interface receives parameters and
commands from the computer and transmits the patient use data to
the computer.
15. A physical therapy apparatus as set forth in claim 14 wherein:
in the administrative mode treatment parameters are received from
the computer and stored in the external memory; in the treatment
mode the patient monitor controls an exercise session according to
the stored treatment parameter, and takes and stores the patient
use data in the external memory; and in the data transfer mode the
patient use data from the exercise session is transmitted to the
computer.
16. A physical therapy apparatus as set forth in claim 15 wherein
the patient use data for a plurality of exercise sessions are
stored in the external memory, such that in the data transfer mode
the stored patient use data from the plurality of exercise sessions
are transmitted to the computer.
17. A physical therapy apparatus as set forth in claim 16 further
comprising: a electronic device identifier affixed to the
therapeutic device, wherein the plurality of sensors includes a
device sensor connected to the electronic device identifier, and
wherein in the administrative mode a plurality of treatment
parameters for different therapeutic devices are stored in the
external memory, such that in the treatment mode the device sensor
identifies the therapeutic device treatment parameters for the
therapeutic device from the plurality of treatment parameters.
18. A physical therapy apparatus as set forth in claim 17 wherein
the plurality of sensors includes a position sensor for measuring a
position of the therapeutic device.
19. A physical therapy apparatus as set forth in claim 18 wherein
the plurality of sensors includes a temperature sensor for
determining when the therapeutic device is being worn by a
patient.
20. A physical therapy apparatus as set forth in claim 19 wherein
the patient monitor includes a timer for determining when a
predetermined time period has expired since the position sensor
detected a stopping of movement of the therapeutic device
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation of U.S.
application Ser. No. 10/421,965 for PATIENT MONITORING APPARATUS
AND METHOD FOR ORTHOSIS AND OTHER DEVICES, filed on Apr. 23, 2003,
the content of which is incorporated by reference in its
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a patient monitoring system
and method that can be used, for example, with an orthosis for
physical therapy.
[0004] 2. Description of Related Art
[0005] In the field of medicine, rehabilitation after surgery or
other major medical procedures has been an important issue for
researchers. As shown in U.S. Pat. Nos. 5,395,303; 5,285,773;
5,213,094; 5,167,612; 6,502,577; 6,113,562 and 5,848,979,
continuous passive motion has been used to treat conditions such as
the glenohumeral joint adhesive capsulitis. These patents teach
using stretching principles in order to treat one of the major
problems patients are referred to physical therapists for: lack of
a full range of motion in their joints. The orthosis devices of
these patents simulate manual therapy techniques used in clinical
settings, combining the principles of stress relaxation and
progressive stretch to achieve permanent elongation of soft
tissue.
[0006] Once a patient has been prescribed treatment with one of the
rehabilitation orthosis devices, a major concern is patient
education and compliance. To maximize improvement in range of
motion the patient must comply with the prescribed protocol and the
patient improvement must be tracked. The exercise protocol for
these orthosis devices is well established, and should be followed
closely to ensure the best treatment possible. First, the patient
fits the orthosis as specified by the device specific instructions.
Then the patient rotates the knob of the orthosis device until a
slight stretch is felt. This stretch should not be painful. Now the
patient holds this position for a predetermined time period (e.g.,
five minutes), and then this procedure is repeated for a
predetermined number of stretches (e.g., 6 stretches). During the
first week of the patient's treatment, typically one session a day
is performed. During the second week, typically two sessions per
day are performed. During the third and following weeks, typically
three sessions per day are performed.
[0007] The above described orthosis devices allow the patient to do
these sessions outside of the confines of the doctor's or physical
therapist's office. Due to the fact that there are no medically
trained personnel to oversee this treatment, the opportunity to
stray from the protocol is introduced. In addition, the patient is
responsible for the tracking of his or her own progress until
reporting back to the physical therapist or doctor. Both of these
conditions have the possibility of introducing a high margin of
error. Most recently, physicians have expressed an interest in
keeping better records of an individual patient's progress during
the rehabilitation process. Unfortunately, in many cases, since the
rehabilitation process occurs mostly within the confines of the
patient's home, it is difficult for a physician to keep an accurate
record of the patient's progress.
[0008] There are other areas in which patient education and
compliance outside the immediate supervision of a health care
professional remain problematic. For example, electrical
stimulation of bone growth for treatment of fractures requires a
regime of therapy that demands patient adherence in order to
optimize the stimulatory effects.
[0009] Thus, there exists a need for an improved patient monitoring
system and method.
SUMMARY OF THE INVENTION
[0010] The present invention provides a monitor for use with a
device, such as an orthosis device, that detects the type of
orthosis device to which the monitor is attached, so that the
monitor may access the correct parameters and/or firmware
appropriate for the attached orthosis device without the need for
such parameters and/or firmware being downloaded to the
monitor.
[0011] The present invention also provides a monitor for use with
an orthosis device that provides assurances the patient is actually
wearing the orthosis device during his/her exercise period and is
not falsifying usage, such assurances being provided by taking
temperature measurements showing that the orthosis device is being
properly used.
[0012] The present invention also provides a monitor used with an
orthosis device having first and second carriage members for
rehabilitative stretching by a patient during physical therapy. The
monitor takes position measurements of the carriage members to
determine if a stretch is being held in accordance with a
stretching protocol.
[0013] In another embodiment, the monitoring system notifies the
patient that the time period for holding a stretch has terminated
in accordance with a stretching protocol.
[0014] Consistent with the title of this section, the above summary
is not intended to be an exhaustive discussion of all the features
or embodiments of the present invention. A more complete, although
not necessarily exhaustive, description of the features and
embodiments of the invention are found in the section entitled
"Detailed Description Of The Preferred Embodiments".
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] A more complete appreciation of the present invention and
many of the attendant advantages thereof will be readily obtained
as the same becomes better understood by reference to the following
detailed description when considered in connection with the
accompanying drawings, wherein:
[0016] FIG. 1 is a view of an illustrative orthosis device used
with the monitor in accordance with the present invention.
[0017] FIG. 2 is an enlarged sectional view of tower of FIG. 1
including the drive mechanism.
[0018] FIG. 3 is a block diagram of the monitoring system in
accordance with the present invention.
[0019] FIG. 4 is a block diagram of the hardware used in the
monitor of the present invention when in the treatment mode of
operation.
[0020] FIG. 5 is a block diagram of the hardware used in the
monitor of the present invention when in the data transfer mode of
operation.
[0021] FIG. 6 is a schematic diagram of the position sensor used in
the present invention.
[0022] FIG. 7 is a flow chart of the firmware embedded in the
monitor of the present invention.
[0023] FIG. 8 is a detailed schematic of the hardware used in the
monitor of the present invention.
[0024] FIG. 9 is a schematic of the circuitry for the sensors used
in the monitor of the present invention.
[0025] FIG. 10 shows circuit diagram of an alternative embodiment
of the monitor which includes a device type sensor in accordance
with another aspect of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0026] Referring to FIGS. 1 and 2, there is illustrated one of many
possible prior art orthosis devices, generally indicated by the
reference number 10, which may be used with the patient monitor of
the present invention. More specifically, this particular
illustrative orthosis device 10 is described in U.S. Pat. Nos.
5,395,303; 5,285,303; 5,285,773; 5,213,094; and 5,167,612 to
Bonutti, et al., which are incorporated herein.
[0027] In FIG. 1 the orthosis device 10 is illustrated as attached
to a human arm, for moving the elbow joint which is between the
upper arm and the forearm. The orthosis 10 includes a first cuff 12
for attachment to a first body portion 14 such as the forearm, and
a second cuff 16 for attachment to a second body portion 18 such as
the upper arm. The term "cuff" as used herein means any suitable
structure for transmitting the force of the orthosis to the limb
portion it engages. The first body portion 14 is joined to the
second body portion 18 at the elbow joint designated A. Each of the
first and second cuffs 12 and 16 includes a plurality of loop
connectors 20 for receiving straps extending around the body
portions 14 and 18 to clamp the cuffs 12 and 16 to the body
portions 14 and 18. The first cuff 12 is mounted for sliding
movement on a first cuff arm 22. The term "cuff arm" as used herein
means any suitable structure for transmitting the force of the
orthosis to the cuff and thence to the limb portion. The first cuff
arm 22 is pivotally mounted by a pin 24 to a tower 26. The first
cuff arm 22 includes a support 28. A first lever arm 30 extends
from the tower 26 and is pivotally connected to the support 28 by a
pin 32. The first lever arm 30 is pivotally connected to a cuff
actuator block 34. The cuff actuator block 34 is fixed to the first
cuff 12 and is slidable along the first cuff arm 22 in a manner as
described below. The second cuff 16 is mounted for sliding movement
on a second cuff aim 40. The second cuff arm 40 is pivotally
mounted by a pin 42 to the tower 26. The second cuff arm 40
includes a support 44. A second lever arm 46 extends from the tower
26 and is pivotally connected to the support 44 by a pin 48. The
second lever arm 46 is pivotally connected to a cuff actuator block
50. The cuff actuator block 50 is fixed to the second cuff 16 and
is slidable along the second cuff arm 40 in a manner as described
below.
[0028] As shown in FIGS. 1 and 2 the tower 26 is a box-like
structure including a lower housing 66 and an upper housing 70
joined by a front plate (removed) and a back plate 53. A drive
mechanism for the orthosis device 10 is disposed substantially
within the tower 26. The drive mechanism includes a manually
actuatable knob 52 (FIG. 1) which is fixed to a shaft 54. The shaft
54 extends into the tower 26 and a gear 56 (FIG. 2) is fixed to the
shaft. The gear 56 engages external gear teeth 58 on a gear 60.
Rotation of the gear 56 about its axis causes rotation of the gear
60 about its axis. The gear 60 is fixed to an externally threaded
lead screw 62. One end of the lead screw 62 is journalled for
rotation in a bushing 64 mounted in a lower housing 66 of the tower
26. The opposite end of the lead screw 62 is journalled for
rotation in a bushing 68 mounted in an upper housing 70 of the
tower 26. An arm actuator block or base link 72 has an internally
threaded opening 74 though which the lead screw 62 extends in
threaded engagement. As the lead screw 62 rotates, the actuator
block 72 moves axially along the lead screw 62 within the tower 26.
This mechanism provides the "rotating means" for rotating the first
cuff arm 22 relative to the second cuff arm 40 and thereby
expanding or reducing the angular relationship therebetween.
[0029] In operation, the orthosis device 10 of the prior art may
provide for distraction of the joint through an entire range of
motion. Movement of the cuff arms to extend the joint results in
distractive forces being applied to the joint. These distractive
forces are limited and controlled by having the cuffs 12 and 16
slidable on the cuff arms 22 and 40, respectively. The cuffs 12 and
16 are selectively moved along the cuff arms 22 and 40, during
relative movement of the cuff arms 22 and 40, to provide the proper
amount of distractive forces to the joint and to limit compressive
forces on the joint. Thus, the orthosis device 10 illustrates one
of many orthosis devices that are well suited for stretching
therapy.
[0030] It should be understood that the orthosis device 10 can be
used to extend or flex other joints in the body, such as a knee
joint or a wrist joint or ankle joint, with the construction of the
orthosis 10 in such case being varied to fit the particular
application. A few more illustrative examples are shown in U.S.
Pat. No. 6,502,577 for finger joints orthosis, U.S. Pat. No.
6,113,562 for a shoulder orthosis, and U.S. Pat. No. 5,848,979 for
a hand orthosis. Moreover, it is contemplated that the monitoring
unit of the present invention may also be used for other types of
devices, including, but not limited to, rehabilitative devices
implementing isometric exercises and those in the continuous
passive motion (CPM) area.
[0031] To generalize the description of the one class of orthosis
devices that may be used with the present invention, such as
orthosis devices including (but are not limited to) the stretching
orthosis device 10 of FIGS. 1 and 2, isometric orthosis devices,
and CPM orthosis devices, the following generic terminology is used
in the appended claims. The orthosis devices used with the
monitoring system in accordance with the present invention
generally are for moving a first portion and a second body portion
of a patient connected by a joint. These orthosis devices typically
include a first carriage member for receiving the first body
portion and a second carriage member for receiving the second body
portion. Each carriage member has proximal and distal ends. The
second carriage member and the second carriage member are movably
connected about their proximal ends so that the first carriage
member pivots relative to the second carriage member about an axis
intermediate to the first and second carriage members. Hence, the
carriage members may move from a first position to a second
position and in so doing change the angle defined by the two
carriage members.
[0032] In the illustrative embodiment of the stretching orthosis
shown in FIGS. 1 and 2, the first and second carriage members each
include the cuff arm 22 or 40 and a cuff 12 or 16 for connecting
cuff arm 22 or 40 to one of said body portions 14, with the cuff 12
or 16 slidably mounted on the cuff arm 22 or 40. In other orthosis
devices not directed toward stretching exercises, such those
directed toward isometric exercises, the first carriage member and
the second carriage member are merely pivotally connected at their
proximal ends (frequently adjustably locked in fixed relationship).
An example of a simplified orthosis device is shown in U.S. Pat.
No. 5,116,296 to Watkins et al. and is incorporated herein by
reference thereto. Another example is described in U.S. Pat. No.
5,052,375 to Stark et al. (also incorporated herein by reference
thereto), wherein the two carriage members are interconnected by an
adjustable hinge and the angle between the respective distal end
sections can be adjusted relative to one another. The angular
position between the first carriage member and the second carriage
member is one of the parameters that is measured by the monitoring
system in accordance to be present invention, but as will be
discussed hereinafter, the monitoring system includes other sensors
for measuring other parameters, such the identification of the
orthosis device to eliminate the need for external unit
configuration and temperature as an indication the orthosis device
is actually being used.
[0033] In the case of using the temperature and device
identification sensors, the monitoring system of the present
invention may be used with any number of different types of
orthosis devices. More specifically, any orthosis device needing
assurances that the user is actually wearing the orthosis device
during his/her exercise period using the orthosis, and not
falsifying usage, may make use of the monitoring system of the
present invention for temperature measurements which provides
evidence that the orthosis is being properly used. Likewise, with
monitors using different parameters or firmware for different
orthosis devices, the family of orthosis devices may make use of
the device type identification sensor, which will allow the monitor
to access the correct parameters and/or firmware appropriate for a
particular orthosis device without the need for parameters and/or
firmware to be downloaded to the monitor.
[0034] Referring to the block diagram of FIG. 3, a patient
monitoring system 100 for use with a device such as a physical
therapy orthosis, like the orthosis device of FIGS. 1 and 2, is
shown. The patient monitoring system 100 includes a standalone
monitor 102 which can be incorporated into the orthosis device of
FIGS. 1 and 2. More specifically, the monitor 102 has a data
acquisition unit 104 mounted on the outside of the tower 26 (shown
by a dashed line), such tower 26 being described with respect to
FIGS. 1 and 2. Additionally, the monitor 102 includes a plurality
of sensors 105, three of which are shown in FIG. 3 as a position
sensor 106, a temperature sensor 108, and an optional device type
sensor 110. As shown by the dashed line, the temperature sensor 102
and the device sensor are mounted on one of the cuff arms 22 and/or
40 shown in FIGS. 1 and 2.
[0035] As an overview of the monitoring system 100 when applied to
a stretching orthosis such as that shown in FIGS. 1 and 2, a
patient is prescribed treatment by a physician or physical
therapist, with the prescribed treatment using a given orthosis
device having a monitor 102. In a first mode of operation (data
transfer or administrative mode), the appropriate orthosis device
is modified to fit a patient's specific requirements by the
physician or physical therapist downloading the required parameters
to the monitor 102. This data transfer mode of operation is used
only by the physical therapist or doctor.
[0036] In a second mode of operation (treatment mode), the user
connects the sensors 105 to the data acquisition unit 104. The
monitor 102 controls each exercise session with the patient by
stepping the patient through his or her treatment following the
previously described stretching protocol. During the critical
sections of this treatment in a first mode of operation, the
monitor 102 monitors the operation by taking measurements from the
sensors 105 and storing them in memory. These retrieval and storage
operations are accomplished via a micro-controller and an EEPROM,
which will be described in detail hereinafter. Preferably, the unit
104 is able to store approximately two months worth of sessions.
Alternatively, the data can be transmitted to another data storage
unit. This transmission can occur instantaneously or at set
intervals.
[0037] At the time of the follow-up appointment with a physician or
physical therapist, the user disconnects the unit 104 from the
orthosis device and disconnects the sensors 105. Then the user
brings the unit 104 to the physician or physical therapist. At this
point, the unit 104 again uses the data transfer mode of operation.
The information is transferred from the unit 104 to a computer 112
at the office of physician or physical therapist. The memory
containing such data in the unit 104 is then erased. This computer
112 uses data analysis software to further manipulate the data and
present it for display by the computer 112.
[0038] Overviews of the hardware of the data acquisition unit 104,
as configured in the above-described modes of operation, are
provided in FIGS. 4 and 5. The data acquisition unit 104 includes a
microprocessor 120 (PIC16F877) and an external memory 122. In both
FIGS. 4 and 5, the microprocessor 120 (PIC16F877) uses the external
memory 122 and is electrically coupled to a display device 124, in
the form of a parallel LCD. FIG. 4 shows the hardware configured
for the treatment mode, wherein the microcontroller 120 is
electrically coupled to the sensors 105 via buses 126 and 128. FIG.
5 shows the hardware configured in the data transfer mode to be in
communication with the computer 112 via a cable 130 coupled to an
RS-232 port 132 on the microprocessor 120. The MAX 233, shown by
reference numeral 133, is a Maxim MAX233a device which is used to
convert the serial communication voltages used on the
microprocessor 120 to the RS-232 levels required by the computer
112,
[0039] With reference to FIGS. 3, 4 and 5, the two modes of
operation of the monitor 102 will be described in detail, with the
mode of operation being set by the computer 112 via the cable 114.
The data transfer mode is entered when the monitor 102 is turned on
with the monitor-to-PC cable 114 being inserted into the data
acquisition unit interface provided by the port 116 of the monitor
102. As described above, this mode is used for the configuration of
the monitor 112 as well as the retrieval of the acquired data after
the monitor is returned by the patient. Through device
configuration by the computer 112, various options may be set
allowing the monitor 102 not only to be used with the illustrative
orthosis device of FIGS. 1 and 2, but also to be used with the
entire family of rehabilitation devices without modifying the
hardware or firmware of the data acquisition unit 104. The device
configuration options are stored on various orthosis devices in the
memory 122. The communications protocol for configuring the monitor
102 is provided below in TABLE I: TABLE-US-00001 TABLE I Expected
Command Name Arguments Description 0x00 Send data none Sends the
patient data to the PC via the RS-232 port. 0x11 Set reps number of
reps Set the number of stretches (ASCII) the patient performs per
session. 0x22 Set mins number of Set the number of minutes minutes
(ASCII) the patient will hold each stretch. 0x33 Set secs number of
Set the 10's position of the seconds (ASCII) number of seconds to
hold each stretch. 0x44 Set ID device id Sets the device ID. The
first time monitor is restarted & connected to orthosis device
after setting the device ID, the user will be prompted to configure
the device. 0x55 Set clock minutes (BCD) Sets and configures the
hours (BCD) real time clock with the given date (BCD) arguments.
month (BCD) 0x66 Set mask comparison mask Sets the mask used to
compare measurements for position sensor. This is used to
compensate for noisy sensors. 0xFF Delete none Marks all data as
deleted from the EEPROM storage.
[0040] It should be noted, that with the above protocol, the device
id (identification) is set by the computer 112. In this embodiment,
the device type sensor 10 shown in FIG. 3 is not used. Optionally,
the device type sensor 110 may be used, in which case the "id"
command is not needed. The alternative embodiment using the device
type sensor 110 is described hereinafter.
[0041] The treatment mode is used when connected to the sensor 105
through the data acquisition unit interface 132. The sensor
hardware unit contains all the necessary circuitry for the
operation of the current sensors 105 as well as power and ground
for the expansion ports. Referring back to FIGS. 1, 2 and 3, the
temperature sensor 108 is embedded into one of the cuffs 22 or 40
of the orthosis device 10. The temperature sensor 108 is not
necessarily intended for an accurate measurement of the patient's
body temperature while using the orthosis device 10, but is a way
to ensure that the patient is actually wearing the orthosis device
10 during the treatment session.
[0042] Modifications to the tower 26 shown in FIG. 2 to include the
position sensor 106 of FIG. 3 are shown in the schematic diagram of
FIG. 6. Referring to FIG. 6, the overall structure remains the same
as shown by the lead screw 62, lower housing 66, actuator block 74,
and upper housing 70. What is added is a spring 130 which extends
from the lower housing 66 to the upper housing 70 and is disposed
in parallel relationship with the lead screw 62. The spring 130
passes through an aperture 132 in the actuator block 74. An
electrical contact 134 is embedded in the upper housing 70 and is
in electrical contact with an upper end of the spring 130. A second
electrical contact 136 is embedded in the actuator block 74 and is
in electrical engagement with the spring as it slidingly passes
through the aperture 132 when the actuator block 74 is moved along
the lead screw 62, such movement being caused by the rotation of
the lead screw, as discussed with respect to FIGS. 1 and 2. More
specifically, referring back to FIGS. 1 and 2, in addition to FIG.
6, the rotation of the lead screw 62 is used to drive the device
cuffs 22 and 40. As the knob 52 on the exterior of the tower 26 is
turned, the actuator driver 72 moves up and down accordingly, thus
moving the cuffs 22 and 40. By placing the contact 136 on the
actuator driver 72 and one at the top of the spring, a variable
resistor is created. This variable resistor is then used in a
voltage divider circuit (shown hereinafter) to create a
center-tapped potentiometer to monitor the angle formed by the arms
22 and 40 during the treatment.
[0043] Referring to FIGS. 3-5, the first time that the hardware
sensors 105 are attached after the device identification number has
been set during the above described data transfer mode, the user
will be prompted to extend the orthosis device 10 to the maximum
and then the minimum position to calibrate the device 10. These
measurements are then stored in the memory 122 for use during the
remainder of the treatment sessions to calculate the angle between
the arms of the device 10.
[0044] Referring to FIG. 7, both the treatment mode of operation
and the data transfer mode of operation for the monitor 102 are
described in a flow chart of a firmware program 140, which is
embedded in the data acquisition unit 104. At step 142, the
firmware program 140 waits until a button is pushed by the
physician or physical therapist specifying the selected mode of
operation. At step 142, the mode is checked, and if the user
selected the treatment mode, the program 140 branches to the
"Treatment" branch. If the user selects the data transfer mode of
operation, then the program 140 branches to the "Data Transfer"
branch.
[0045] After the patient/user begins his or her treatment session,
the monitor 102 has already been set for the treatment mode of
operation. First, a splash screen is displayed with the name and
version of the firmware included in the data acquisition unit 104.
The session runs according to the following flow chart shown in
FIG. 7, as shown on the left side. At step 146, the user is
prompted to turn the knob 52 (see FIG. 1) until a gentle stretch is
felt. At step 146, the program checks to see if there is power on
the sensor bus. If yes, the program goes to step 150 and if no, the
program branches to step 152. The micro-controller 120 at step 150
begins taking measurements of the position sensor 106 in the tower
26 (see FIG. 3) to see if the patient has stopped stretching. The
micro-controller 120 (see FIG. 3) continues in a loop 154 until the
current position measurement of the position sensor 106 matches the
last one, which indicates that the patient has stopped stretching.
More specifically, the user definable mask, set via the RS-232 port
in data transfer mode, is used to compensate for noisy sensors 106,
and the natural variation in analog to digital conversion. When the
two position measurements of the position sensor 106 match, it is
assumed that the user of the orthosis device 10 has stopped turning
the knob 52 and is ready to hold the stretch. The position sensor
106 of FIG. 6, in combination with execution of this firmware
routine, provides the "position sensor means" for detecting when
there is a stop in movement of the first arm cuff 22 relative to
the second arm cuff 40 when a patient starts to hold a stretch.
[0046] Upon the program determining that the patient has started to
hold a stretch, the program proceeds to step 156, where the power
is turned off on the sensor bus and the program waits a preset
amount of time, e.g., 5 minutes. As specified in the previously
described stretching protocol, the user is to hold the stretch for
5 minutes and the time is displayed on the LCD 124 (see FIG. 3). As
shown in Table I above, the time to hold a stretch is also
configured in the data transfer mode, which allows for easy
modifications of this protocol if needed. This firmware routine
provides "timing means" for generating a patient detectable signal
aster the expiration of the predetermined time period, with in this
illustrative example, is 5 minutes.
[0047] Upon completion of the hold for the stretch, the program 140
proceeds to step 158, where power is turned on to the sensor bus,
all measurements of the sensors are recorded and a sound buzzer is
triggered to indicate the end of the period for holding the
stretch. More specifically, all of the analog conversions of the
sensor 106 are repeated and stored into the memory 122. When all
the measurements are saved, a 16 bit address pointer for the memory
122 is updated in the micro-controller. If the user interrupts a
stretch before it is completed, then that session will
automatically be overwritten by the next session without the need
for more complicated error checking. At step 152, if the number of
stretches is less then the amount defined by the treatment
protocol, the stretch loop is repeated via loop 160. If the number
of stretches completed is equal to the amount defined by the
treatment protocol at step 152, then a session complete prompt is
displayed on the LCD 124 and the program 140 proceeds to step 162,
where the power is turned off and then the program goes to sleep at
step 164.
[0048] Referring to the right side of the flow chart in FIG. 7, the
data transfer mode of operation is shown. As previously described
with respect to FIG. 5, the data acquisition unit 104 is in
communications with the computer 112. First, the physician or
physical therapist would have selected this mode of operation and
the program would recognizes the same at step 144 and taken the
"Data transfer" branch to step 170. If there is a timeout, the
program 140 proceeds to a sleep state at step 172. If there is no
timeout, then the program proceeds to step 174, where the
micro-controller of 120 (FIG. 5) fetches an instruction from the
computer 112. The instructions from the computer 112 include, but
are not limited to, the commands listed in TABLE I above. The
micro-controller 120 interprets the instruction at step 176.
Depending upon the instruction, the program takes the "transfer"
branch or the "delete" branch.
[0049] When the program 140 takes the "transfer" branch, at step
178, the program sends the product ID to the computer 112. Then at
step 180, all the sensor data is transferred from the memory 122 to
the computer 112. When the program 140 takes the "delete branch",
at step 182, the program 140 obtains from the computer 122 the
product ID (see TABLE I above), then sets the product ID at step
184 and erases the existing sensor data by setting all sensor data
to 0xFF (see TABLE I above). Then the program 140 proceeds to its
sleep state at step 188. With this embodiment, it should be clear
that the device sensor 110 is not included, because the computer
112 sets the device ID.
[0050] In FIG. 8 a detailed schematic 190 of the hardware for the
data acquisition unit 104 of FIG. 3 is shown, with such hardware
having been generally described on a higher level in FIGS. 4 and 5.
Referring to FIG. 8, the micro-controller 120 preferably comprises
a Microchip PIC16F877 micro-controller. This PIC16F877
micro-controller is a 40 pin, 8 bit CMOS Flash microcontroller
configured using the following pin assignments in TABLE II below:
TABLE-US-00002 TABLE II Direction/ Name Mode Port 1 Temp Analog RA0
2 Position Analog RA1 3 Expand 1 Analog RA2 4 Expand 2 Analog RA3 5
Expand 3 Analog RA4 6 LCD RS Out RB0 7 LCD R/W Out RB1 8 LCD E Out
RB2 10 Mode 1 In RB4 11 Mode 2 In RB5 14 Buzzer Out RC0 16 SCL I2C
RC3 17 SDA I2C RC4 18 Serial Tx USART RC6 19 Serial Rx USART RC7 20
LCD DB0 Out RD0 21 LCD DB1 Out RD1 22 LCD DB2 Out RD2 23 LCD DB3
Out RD3 24 LCD DB4 Out RD4 25 LCD DB5 Out RD5 26 LCD DB6 Out RD6 27
LCD DB7 Out RD7
[0051] The external memory 122 is a Microchip 24AA64I2C EEPROM. The
memory 122 is connected to the controller 120 via the I2C serial
communications bus 192. The memory 122 has 64 K bits of EEPROM and
is used for the storage of the patient data. The operation of this
device is limited to the low speed bus operation due to the use of
a 4 MHz crystal. The LED 124 is a Hitachi 44780 compatible LCD
operating in 8 bit parallel mode. The Hitachi LCD is an industry
standard, and was chosen because any 14.times.2 LCD could then
easily be substituted. A Dallas Semiconductor DS1307I2C real time
clock 194 is provided, which is connected to the I2C bus 192 along
with the EEPROM memory 122. This clock 194 is used to record, to
the nearest hour, when the actual stretch sessions were performed.
This allows the PC software for the computer 112 (see FIG. 3) to
group the stretches into sessions.
[0052] This micro-controller 120 has an onboard port capable of
8-channel analog to digital conversion at 10-bit resolution making
it a powerful tool in data acquisition. The controller 120 also
supports both SCI and I.sup.2C serial communication. The SCI module
of the controller 120 is used to communicate with the computer 112
through standard RS-232 port of a RS-232 communications interface
196. This communications, for example, allows for further analysis
of the data by the physical therapist or doctor. The I.sup.2C
protocol will used to interface with the memory 122 and the real
time clock 194. The use of external memory 122 will be needed as
the 128 bytes of EEPROM storage for the internal memory of the
controller 120 is insufficient to store the data acquired from the
sensors. The controller 120 is electrically coupled to a Piezo
buzzer (not shown) via the pin RCO being connected to the terminal
199.
[0053] In FIG. 8, there is also shown the header 198 (including
insulated terminals or leads) for connecting the LCD 124 of FIGS. 4
and 5. Also, there is shown a header 200 for connecting with the
sensors (terminals J3-J6) and the computer 112 (for selecting the
mode of operation via terminals J8 and J9). The sensor hardware
schematic 210, including the header 200, is shown in FIG. 9 in more
detail. Referring to FIG. 9, the terminals J1-J12 of header 200 are
electrically coupled to the ports of the controller 120 as
specified in TABLE II. A first variable resistor RV1 comprises the
resistance of the position sensor 106 (FIG. 3) and a second
variable resistor RV2 is used to match the resistance to create a
voltage divider as previously described, to form a potentiometer,
used with the position sensor 106 (FIG. 3).
[0054] In an alternative embodiment of the sensor hardware of FIG.
9, it is contemplated that the expansion terminals J5-J7 may be
used for additional sensors, including blood pressure, heart rate,
and stress indicators. To accomplish this, the sensor bus is
modified to use both 3.3 and 5.0 volt supply lines to allow for the
plug-in of multiple expansion sensors. With a selectable supply
voltage, a universal connector is provided for both patient data
acquisition in the treatment mode and for data transmission to the
doctor's office in the data transmission mode selected by
cable.
[0055] Referring to FIG. 3, the temperature sensor 108 is a Dallas
Semiconductor LM34DZ temperature sensor. This temperature sensor
was not used to measure the patient's actual temperature hut was
used to confirm that the patient was actually using the device.
[0056] With reference to FIG. 3, the patient monitoring system
software running on the computer 112 briefly will be described. The
software application provides a therapist a way of obtaining the
data stored on the data acquisition unit 104 and presents it in a
meaningful way. One function of the Patient Monitoring System
software is the ability to view patient records. The system checks
to ensure that all fields are entered and informs the user if one
or more of the fields are blank. In addition, the system checks the
patient name entered against the array of current patient names. If
the entered name is invalid, the system reports no patient found.
Otherwise, the system uses the "Patient ID" field from the array to
access the data file for that particular patient. This file
contains all of the information obtained from the data acquisition
unit (FIG. 3) from previous visits. The system then displays the
contents of the file in the grid at the bottom of the form. The
grid is another built-in control of Visual Basic 6.0 called the
"Microsoft FlexGrid Control 6.0". In addition, the system displays
other patient information such as the name of that patient's
physician and the date that patient received their orthosis
device.
[0057] Another function provided by the system software is the form
for actually acquiring data from the data acquisition unit 104
(FIG. 3). The screen layout is very similar to that of the form for
viewing patient records that are already stored in the system. This
form also uses a grid to display the data once it has been obtained
from the Data Acquisition Unit. In order to facilitate reading from
a communications port, Visual Basic has a control entitled
"Microsoft Comm Control 6.0". This control allows communication
between the personal computer 112 (FIG. 3) and any device attached
to a designated communications port. The user also has the option
to change what communications port the system will look for the
data acquisition unit on in case other communications ports are
already in use by that individual's computer. By default, this is
set to COM1.
[0058] When the user clicks on the "Acquire" command button, as in
other forms, the system checks to see first if all proper text
fields have been filled in, and then if the patient name entered is
valid. Also, it informs the user to make sure that the data
acquisition unit is securely connected to the selected
communication port. Next, the system sends out a zero byte on the
communication port, which informs the data acquisition unit to
begin sending data. The patient monitoring system software then
reads in the raw data from the unit, one byte at a time, and stores
it into a temporary file called "output.dat". After the data
acquisition unit has completed sending all of its data, the system
software sends out a byte equal to 0xFF in hexadecimal to inform
the data acquisition unit to wipe out its memory and the serial
communication is complete.
[0059] The next major task that the software application does
involves manipulating data. This includes converting the raw data
obtained from the data acquisition unit into meaningful values,
saving them in the proper patient's file, and displaying them in
the grid for the user to examine. First, the system goes through
and converts all of the data received from the data acquisition
unit into actual integers, instead of the binary form that they are
initially sent in. The first major changing of any data occurs with
the data representing the time and the date. Actually, the date is
composed of a byte representing the month, and one representing the
day. The data acquisition unit transmits all three of these values:
month, day, and hour, in BCD form (see TABLE I). To do this, the
system subtracts a factor of six from the data based on the value
of its upper four bits. For example, the BCD value of thirty-one is
stored in binary as 0011 0001. The system will subtract eighteen
(six times the value of the upper four bits, three) from the
integer value of the number, forty-nine, to produce the correct
result of thirty-one.
[0060] The next major conversion occurs with the "Position"
readings taken by the position sensor 106 (FIG. 3) and transmitted
from the data acquisition unit 104. The data acquisition unit
transmits values called Stretch_Min and Stretch_Max during its
serial communication with the patient monitoring software. The
difference between these two numbers is computed and adjusted to
fit a scale of based on the particular device. For example, a one
orthosis device allows a range of motion from one hundred
thirty-eight to negative ten degrees. Next, each "Position" value
is then adjusted accordingly to fit within these two values. In
reality, this conversion may not be exactly linear, but since the
position sensor need not be as highly accurate as other more
expensive models, assuming linearity in this case is
acceptable.
[0061] The final conversion that the system makes involves the
readings from the temperature sensor 108 (see FIG. 3). Based on the
specifications of the temperature sensor itself, the voltage
increases ten milivolts per degree. The system then fits the binary
data into the range of acceptable values. For the most part, the
temperature data should be relatively constant. Its primary purpose
is to ensure that the patient is actually wearing the device while
using it, instead of simply turning it on to take false readings.
As a result, the therapist would be able to tell if a reading was
false by seeing if any of the temperature values were conspicuously
above or below any realistic, expected values. This helps to ensure
proper adherence to the stretching protocol.
[0062] In FIG. 10 an alternative embodiment of the monitoring
system 100 shown in FIG. 3 is shown. In this alternative
embodiment, the device type sensor 110 shown in FIG. 3 is used.
Although shown in FIG. 3, the sensor 110 was not used in the first
embodiment, in that the device ID was downloaded by the application
software operating on the computer 112 to the data acquisition unit
104. But in this alternative embodiment, the device ID is obtained
via the sensor 110. Referring to FIG. 10, each orthosis device is
given its own unique resistor R2. Typically, this resistor is
mounted on orthosis separate from the data acquisition unit 104, so
that the data acquisition unit 104 is not device specific. In the
case of the orthosis 10, the resistor R2 enclosed in a protective
casing and the casing is mounted to one of the arms 22 or 40. The
resistor R2 is electrically coupled on one side to a lead 210
extending from the casing and is electrically coupled at its other
side to ground. The lead 210 is connected to the first expansion
terminal J5 shown in FIG. 9. The device sensor 110 includes
additional circuitry located within the data acquisition unit 104.
This additional circuitry includes a node 212, a capacitor C
(having a value of 0.1 uF) electrically coupled between the node
212 and electrical ground, a resistor R11 electrically coupled
between the node 212 and a voltage source Vcc and a 10 bit
Analog-to-digital converter (ADC) 214 connected to node 212.
[0063] When the node 212 is electrically coupled to the lead 210 of
the resistor R2, the resistor R2 and C are in parallel. The voltage
V.sub.ADC applied to the ADC 214 is as follows: VADC = ( R .times.
.times. 2 R .times. .times. 2 + R .times. .times. 1 ) .times. ( Vcc
) ##EQU1##
[0064] In this case the following conditions apply: no cable
resistance, so that when R2=infinity, V.sub.ADC=Vcc; for the PC
link cable, when resistor R2=0, then V.sub.ADC=0 and that there is
a valid orthosis device with an embedded resister R2. In this case,
the resolution of this device sensor 110 at Vcc=5 V would be
210=1024, so that 5/1024=5 mV. The following TABLE III provides
illustrative values used to identify different orthosis devices (R2
is provided in kilo ohms, V.sub.ADC and Range are provided in
volts, and R1=10 kilo ohms): TABLE-US-00003 TABLE III Device - R2
V.sub.ADC Range 440 4.89 4.85-4.91 150 4.76 4.7-4.82 100 4.54
4.45-4.65 50 4.17 4.09-4.35 32 3.8 3.61-4.06 18 3.21 2.96-3.54 10
2.5 2.23-2.95 5.8 1.83 1.59-2.2 3.3 1.24 1.05-1.55 1.8 0.96
0.63-1.0 1.0 0.45 0.37-0.6 0.5 0.238 0.195-0.55 0.28 0.136
0.110-0.18
[0065] As discussed above, this alternative embodiment is
utilizable where it is desirable to identify a given orthosis
device out of a plurality of possible orthosis devices so as to
eliminate the need for downloading parameters, commands and/or
firmware for that specific orthosis device. In other words, like
the use of the temperature sensor, the orthosis devices making use
of this embodiment of the monitor 100 do not need to be directed
toward those implementing stretching exercises.
[0066] An additional feature that may be added to the Patient
Monitoring System software is a "non-programmers" interface wherein
a Microsoft.RTM. Windows based graphical user interface (GUI) is
provided with a plurality of predetermined unit configurations for
the monitor system 100 of FIG. 3 are provided in a first window.
The user is able to select one of these unit configurations by
clicking on the same and dragging the same to a selection window.
This feature allows for unit configuration by a therapist or family
configuration by an Original Equipment Manufacturer (OEM) without
the need for factory assistance. Additionally, a third window may
be provided wherein the user may select other system or user
variables, by once again dragging the same from the third window to
the selection window.
[0067] Referring to FIG. 3, aspects of the monitor system 100, such
as the device type detector 110 (FIG. 3), may be used with devices
other than the stretching orthosis shown by the illustrative
embodiment of FIG. 6. Other possible applications for these aspects
would be to other types of orthosis devices, such as isometric
orthosis devices. Via software, the monitor system 100 may be
configured to work with any rehabilitation device having position
measurements. The monitor also has the ability to accept other
sensor inputs not accounted for previously. The firmware and
hardware of the monitor system 100 already provides for the
possibility of up to 5 sensor inputs, thus only minor changes in
the PC software are necessary in order to view data output from
other sensor inputs, such as mentioned with respect to FIG. 9.
[0068] After thorough testing of the data transfer capabilities of
the monitor 102, it has been concluded that a higher crystal
frequency may be more suitable for transmitting the required data
over the RS-232 port. Operating the micro-controller at 20 MHz
would significantly decrease the data transfer time and would not
add much to the cost of the product, but allow the I2C bus to
operate in high speed mode as well as allow a higher baud rate for
the RS-232 communications.
[0069] Having a spring measure the amount of extension/flexion may
be a very cost-effective solution for the position sensor 106 of
FIG. 6; however, those skilled in the art will recognize that more
accurate position sensors may be used.
[0070] While various values, scalar and otherwise, may be disclosed
herein, it is to be understood that these are not exact values, but
rather to be interpreted as "about" such values, Further, the use
of a modifier such as "about" or "approximately" in this
specification with respect to any value is not to imply that the
absence of such a modifier with respect to another value indicated
the latter to be exact.
[0071] Changes and modifications can be made by those skilled in
the art to the embodiments as disclosed herein and such examples,
illustrations, and theories are for explanatory purposes and are
not intended to limit the scope of the claims. For example, one
embodiment of the invention has been described as utilizing cables
to transfer data. In this regard, the data transfer can be
implemented using fiber optics, a phone line, a cellular phone
link, an RF link, and/or other communications channels. Thus, the
present invention also envisions the use of wireless means for data
transfer. Such wireless means could use technology like the
CENTRINO mobile technology and personal digital assistants
(PDA's).
[0072] Furthermore, the invention has been described as being used
by patients and health care professionals. However, limited access
to the system and/or data by others could be allowed if authorized
by the patient and/or health care professional. On such scenario in
which limited access could be granted would be for proof of
assurance to an insurance company for a worker's compensation
carrier. Others may also have a need to have some assurance that a
patient is indeed following through with a compliance protocol.
[0073] Although the monitoring system and method have been
described primarily in the context of an orthosis device, other
applications are contemplated by the present invention. These
include other aspects of physical therapy; electrostimulation; bone
growth stimulation; drug delivery systems; cardiac rehabilitation;
generalized rehabilitation, including compliance; implantable
pumps, such as insulin pumps for diabetics; intravenous or
implantable pump medication; and implantable or wearable chemical
sensors to monitor various physiological parameters such as blood
coagulation, blood profile, and blood enzyme content.
[0074] For example, in known pharmaceutical delivery systems, a
rotatable wheel has a number of compartments, each containing an
incremental dose of medications. As programmed, a door opens at a
prescribed time and the pill either by weight or by size would be
opened tip for patient access.
[0075] With the present invention, we can externally monitor these
drug deliveries systems or internally monitor them. The delivery
systems could be used with an implantable pump or implantable blood
chemistry sensor. A wireless readout from the pump or sensor could
attach, for example, to a wrist watch which would monitor the
compliance through a digital readout. A patient could monitor their
own blood chemistries or response to particular medications and
then these results would be broadcast to physician, extended care,
nurse practitioner, nurse, insurance carrier, etc. This would then
monitor the changes to a specific drug and then monitor the serum
chemistries, for example, blood sugar, etc. These are monitored and
then the patient can be monitored through a wireless format to see
how they respond to certain medications and have an instant readout
through this chemistry monitor without actually having the patient
in the office or in the hospital. If the response is not as
desired, the delivery protocol can be remotely changed based on the
measurements.
[0076] In light of the foregoing, it should be understood that
while various descriptions of the present invention are described
above, the various features could be used singly or in any
combination thereof. Therefore, this invention is not to be limited
to only the specifically preferred embodiments depicted herein.
[0077] Further, it should be understood that variations and
modifications within the spirit and scope of the invention might
occur to those skilled in the art to which the invention pertains.
Accordingly, all expedient modifications readily attainable by one
versed in the art from the disclosure set forth herein that are
within the scope and spirit of the present invention are to be
included as further embodiments of the present invention. The scope
of the present invention is accordingly defined as set forth in the
appended claims.
* * * * *