|Publication number||US20070135738 A1|
|Application number||US 11/625,879|
|Publication date||Jun 14, 2007|
|Filing date||Jan 23, 2007|
|Priority date||Apr 23, 2003|
|Also published as||US7182738, US20040215111, US20130274653, US20140171809|
|Publication number||11625879, 625879, US 2007/0135738 A1, US 2007/135738 A1, US 20070135738 A1, US 20070135738A1, US 2007135738 A1, US 2007135738A1, US-A1-20070135738, US-A1-2007135738, US2007/0135738A1, US2007/135738A1, US20070135738 A1, US20070135738A1, US2007135738 A1, US2007135738A1|
|Inventors||Peter Bonutti, Justin Beyers|
|Original Assignee||Bonutti Peter M, Beyers Justin E|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (16), Referenced by (4), Classifications (18), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
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.
1. Field of the Invention
The present invention relates to a patient monitoring system and method that can be used, for example, with an orthosis for physical therapy.
2. Description of Related Art
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.
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.
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.
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.
Thus, there exists a need for an improved patient monitoring system and method.
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.
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.
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.
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.
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”.
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:
As shown in
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.
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.
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
In the illustrative embodiment of the stretching orthosis shown in
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.
Referring to the block diagram of
As an overview of the monitoring system 100 when applied to a stretching orthosis such as that shown in
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.
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.
Overviews of the hardware of the data acquisition unit 104, as configured in the above-described modes of operation, are provided in
With reference to
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.
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
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
Modifications to the tower 26 shown in
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
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
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.
Referring to the right side of the flow chart in
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.
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
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 14×2 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
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 I2C 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 I2C 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.
In an alternative embodiment of the sensor hardware of
With reference to
Another function provided by the system software is the form for actually acquiring data from the data acquisition unit 104 (
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.
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.
The next major conversion occurs with the “Position” readings taken by the position sensor 106 (
The final conversion that the system makes involves the readings from the temperature sensor 108 (see
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 VADC applied to the ADC 214 is as follows:
In this case the following conditions apply: no cable resistance, so that when R2=infinity, VADC=Vcc; for the PC link cable, when resistor R2=0, then VADC=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, VADC and Range are provided in volts, and R1=10 kilo ohms):
TABLE III Device - R2 VADC 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
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.
An additional feature that may be added to the Patient Monitoring System software is a “non-programmers” interface wherein a Microsoft® Windows based graphical user interface (GUI) is provided with a plurality of predetermined unit configurations for the monitor system 100 of
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.
Having a spring measure the amount of extension/flexion may be a very cost-effective solution for the position sensor 106 of
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.
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).
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.
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.
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.
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.
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.
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.
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|U.S. Classification||601/5, 601/DIG.23, 601/33, 601/DIG.19, 601/23|
|International Classification||A61H1/02, A61H1/00, A61F5/01|
|Cooperative Classification||Y10S601/23, Y10S601/19, A61H1/0277, A61F5/0102, A61M5/1723, A61B5/681, A61B5/0022, A61B5/002, A61B5/0205|
|Nov 27, 2007||AS||Assignment|
Owner name: BONUTTI RESEARCH INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MARCTEC, LLC;REEL/FRAME:020155/0973
Effective date: 20071107
|Aug 24, 2011||AS||Assignment|
Owner name: BONUTTI IP, LLC, ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:THE BONUTTI 2003 TRUST-A AND THE BONUTTI 2003 TRUST-B;REEL/FRAME:026802/0024
Effective date: 20050110
|Aug 25, 2011||AS||Assignment|
Owner name: MARCTEC, LLC, ILLINOIS
Free format text: CHANGE OF NAME;ASSIGNOR:BONUTTI IP, LLC;REEL/FRAME:026808/0671
Effective date: 20060418
Owner name: BONUTTI 2003 TRUST-A, ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BONUTTI, PETER M.;BEYERS, JUSTIN E.;SIGNING DATES FROM 20030715 TO 20030718;REEL/FRAME:026808/0491