Patent Grant
9839553
The present invention relates generally to automated orthotic devices, and methods for using an automated orthotic device, and more particularly to an automated body brace for medical or recuperative purposes having the ability to implement a treatment regimen.
An orthotic device or orthosis (commonly known as a brace or splint) is an orthopedic device that is typically applied to a limb or the body. Among other things, the purpose of such a device can be to provide support, protection, pain reduction, or replacement of lost function.
In this regard, a common method of alleviating pain in people suffering from back pain or injuries and promoting healing in post-operative back surgery patients is to stabilize the spine using an orthosis, such as a brace. There are a large variety of braces available depending on the diagnosis and physical needs of the individual. These devices include a multitude of construction materials and designs which can be snugly fitted around the patient's trunk and peripheral area, such as the cervical and pelvic regions.
Such braces are effective in achieving spinal stability if worn properly and consistently, but many patients have difficulty manually adjusting the brace to a tight enough fit for providing adequate support. This is especially true for post-operative patients who are in pain and lack sufficient strength. Patient non-compliance reduces the effectiveness of the brace.
Another drawback of existing braces is their inability to adapt as the patient moves from a standing position to a sitting position. A sitting position may require a different brace tension than a standing position. Further, it is difficult to adjust the brace to have exactly the same amount of tension or even to set a particular tension for a particular patient.
In an attempt to solve some of these issues, prior art back braces include automated back braces that can automatically set the brace to a specified compression or tension level. However, as the patient's condition changes, it might desirable to change the prescribed tension setting. To make such a change, the patient must return to the physician's office. This can be inconvenient for the patient.
Existing automated braces can change their tension settings for sitting and standing positions, but the user must manually activate the change such as by pushing a button on a control module. This can be cumbersome and embarrassing in social situations.
It can readily be appreciated that there is a need for an automated brace that can adjust as a patient's condition changes without the patient being required to return to the doctor's office. It can further be appreciated that there is a need for an automated brace that can adjust the support according to the user's position, without the need for the user to manually adjust the settings. The present invention fulfills these needs and provides further related advantages.
The present invention is embodied in an automated orthotic device comprising a brace and a controller that provides a specified level of support to certain parts of the human body. In one embodiment, the subject invention addresses the problem of a patient having to visit the physician's office every time the prescribed tension setting must be changed, by allowing the physician to store an entire treatment regimen in the brace so that the brace will move to the next prescribed tension setting in the treatment regimen after the passage of a certain amount of time or at the user's command.
In one embodiment, the automated orthotic device comprises a body brace configured to be worn around a portion of a human body, a data storage means, and a controller. The data storage means is configured to store a treatment regimen program that has been determined by a physician and the treatment regimen program comprises a plurality of prescribed tension settings to be carried out in a specified order. The controller is configured to carry out the treatment regimen program by causing the body brace to apply each of the prescribed tension settings according to the specified order of the treatment regimen program.
In another embodiment, the treatment regimen program further comprises a set period of time associated with each of the plurality of prescribed tension settings. The controller is further configured to carry out the treatment regimen program by causing the body brace to apply each of the prescribed tension settings according to the specified order and for the specified period of time for each tension setting specified by the treatment regimen program.
In another embodiment, the controller is configured to apply each of the prescribed tension settings until the user inputs a command to move to the next prescribed tension setting in the treatment regimen program.
In one embodiment, the body brace and controller are further configured to detect brace usage data and the data storage means is further configured to store this brace usage data. The brace usage data may include data on the length of time a user has worn the automated orthotic device and data on the tension settings applied while being worn.
In another embodiment, the treatment regimen program further comprises a set period of time associated with each of the plurality of prescribed tension settings wherein the set period of time specifies the period of time that the automated orthotic device must be worn by the user at the associated prescribed tension setting. The controller is configured to carry out the treatment regimen program by detecting and storing the amount of time the user has worn the automated orthotic device at the current prescribed tension setting and then moving to the next prescribed tension setting in the treatment regimen when the user has worn the automated orthotic device at the prescribed tension setting for the specified amount of time associated with that prescribed tension setting.
In another embodiment of the present invention, the automated orthotic device also includes a network connection means, which allows the controller to receive data from a network and transmit data to a network. Through this network connection means, the automated orthotic device is able to receive a treatment regimen program or receive changes to the current treatment regimen program from a remote computer on the network.
In another embodiment of the present invention, the automated orthotic device also includes a user position detection means. The user position detection means is configured to automatically detect changes in position by a user and adjust the tension setting in response to the user's change in position.
In one embodiment, the user position detection means may be an accelerometer.
The present invention is also embodied in a method for using an automated orthotic device with a treatment regimen. The automated orthotic device comprises a body brace configured to be worn around a portion of a user's body, a data storage means, and a controller. The treatment regimen program comprises a plurality of prescribed tension settings to be carried out in a specified order. The method comprises the steps of receiving a treatment regimen program in an automated orthotic device, storing the treatment regiment program on the data storage means, and applying each of the plurality of tension settings according to the specified order in the treatment regimen program.
The present invention is also embodied in a method for using an automated orthotic device with a treatment network. The method comprises the steps of connecting the automated orthotic device to a network, receiving a prescribed tension setting from a remote computer on the network, storing the prescribed tension setting on a data storage means, and applying the prescribed tension setting around a portion of the user's body.
The present invention is also embodied in a method for using an automated orthotic device with a user position detection means. The method comprises the steps of applying a first prescribed tension around a portion of a user's body, detecting a change in position by the user, and then applying a second prescribed tension setting around the portion of the user's body in response to the detected change in position.
These and other features and advantages of the invention should become more readily apparent from the detailed description of the preferred embodiments set forth below taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.
Embodiments of the present invention will now be described, by way of example only, with reference to the following drawings.
With reference to
The means for automatically tightening the brace can include a cable 16 and a plate 18a or 18b mounted on each brace segment. Each plate 18a or 18b has a series of pulleys 20 mounted on it at staggered positions relative to the other plate. Center points (e.g., point 32) of the pulleys are also distributed across one or more plate. The cable 16 runs serially through the pulleys 20 and is fixed at each end in a manner described more fully below so as to hold the brace segments in position. Pressure sensors 60, 61 are placed in the belt to check the tightness of the belt. One pressure sensor 60 is placed on the abdomen, and the other pressure sensor 61 is placed on the back.
In one embodiment, shown in
In another embodiment, the microprocessor counts the number of rotations made by the motor by optically coupling the motor to the microprocessor's data input circuitry. That number of motor rotations can constitute a setting for the brace and be stored for later recall on the storage device 64. If the number of turns of the motor shaft is used as the setting for the tension of the brace, the tension is repeatable for the same patient. However, because a certain number of turns of the motor shaft 35 is not equivalent to magnitude of tension, i.e., smaller patients may require more turns of the shaft to achieve the same tension as larger patients, the tension of the brace is not presentable to a certain degree of tension.
In another embodiment, the microprocessor 38 monitors and stores the output of a strain gauge either connected within the material of the brace or connected to the cable. The strain gauge measures the tension of the brace. The strain gauge can be a spring-loaded linear potentiometer attached at either end of the cable.
In one embodiment, the controller 34 uses monitoring of the motor current as an indirect indicator to measure the tension in the back brace. If the motor 22 is driven by a MOSFET H-bridge, one of the MOSFETs used to drive the motor can be used in conjunction with the resistor below it to obtain an indication of the tension. An A/D converter can be used to measure the voltage drop across the resistor to indicate the motor current and thus the relative tension on the cable, which is proportional to the tension of the brace. The motor current is periodically polled by the microprocessor.
Additionally, the microprocessor 38 can be adapted to continuously or periodically sense the tension of the brace. Periodic sensing can be accomplished by momentarily turning the motor 22 on. The motor 22 is turned on only to check the tension vis-à-vis its current consumption. This can be accomplished very quickly without tightening or loosening the brace. Since the microprocessor 38 has available the information of the last set tension, by periodically checking the motor current consumption/brace tension and comparing it with what it should be in accordance with the last set tension, it is possible for the microprocessor 38 to determine whether the brace has been taken off. That is, if a patient takes the brace 10 off in the fully tightened condition (which is possible since the brace is held in the front by hook-and-loop fasteners 14), and no loosening of the cable occurs, it will be difficult for the patient to put the brace back on. The microprocessor 38 would sense that the brace is off of the patient, and that there is no tension on the cable 16. When the microprocessor 38 senses that the brace 10 has been taken off, it can unspool the cable 16 so that the brace 10 is automatically ready to be put back on. In one embodiment the microprocessor 38 is configured to poll the current setting and compare it to the last setting every 15 seconds. The timing of the polling can be set to other values.
Continuous sensing of the tension level is most desired, and with continuous or at least short-interval periodic sensing, continuous or semi-continuous adjusting of the tension can be obtained. Continuous sensing may be achieved by, instead of periodically turning the motor 22 on to check the tension of the brace, leaving the microprocessor 38 on continuously to check and adjust the tension of the brace 10. In this manner, precise automatic control of the brace can be obtained. The patient can then have the same level of comfort and compliance with the tension required without any additional input. In one embodiment, a mechanical gear lock is used to maintain tension, thus relieving the need to use the motor 22 to maintain tension. Thus, battery consumption can be reduced and motor life can be extended.
The controller 34 also comprises a storage device 46, possibly a magnetic or optical disk or a solid state drive. The storage device 46 can be used to store prescription data, including a treatment regimen. Prescription data is downloaded onto the controller 34 through an interface device 40. The interface device 40 allows the controller to be connected to a computer or a network. It will be understood that connecting to a network may involve connecting to a computer that is on the network, and connecting to a computer may involve connecting to a network that includes the computer. This connection may be achieved through standard computer connections such as USB or Bluetooth, or through standard network connections such as a WiFi or Ethernet. The network can be the Internet or some local area or wide area network. In one embodiment, means are provided to safeguard prescription data through an encryption scheme or other protection mechanism.
The patient's physician connects his or her computer to the automated orthotic device 10 through the interface device 40. This connection may be accomplished directly between the physician's computer and the orthotic device 10, or it may be a connection over a network. Once the physician's computer and the orthotic device 10 are connected, the physician's computer can upload a treatment regimen to the automated orthotic device 10. In one embodiment. this treatment regimen can be a single prescribed tension setting. In another embodiment, the treatment regimen can be multiple tension settings to be applied as the patient's condition changes or over certain prescribed time intervals. The automated orthotic device 10 may apply the next prescribed tension setting in the treatment regimen after a certain time period, with the orthotic device 10 automatically changing the prescribed setting after a set amount of time or after a set number of hours of use, or the changes can be implemented by user command through controller 34, with the user determining when he or she feels that his or her condition is improving enough to adjust the tension setting to the next prescribed setting. By storing an entire treatment regimen on the storage device 46, the patient can avoid multiple trips to the physician's office to receive adjustments to the prescribed tension setting.
When changes must be made to the treatment regimen, the current invention allows for these changes to be made without the patient going into the physician's office. The interface device 40 allows for the patient to connect the orthotic device to the physician's computer over a wide area network. Through this connection, the physician may upload a new prescribed tension setting or a revised treatment regimen to the controller 34, which would then be stored in the storage device 46. The controller 34 could include an override to allow the user to adjust the tension in the brace to a non-prescribed tension if the tension prescribed by the physician causes discomfort, which may be caused by swelling or changes in the patient's condition.
In addition to storing prescription settings or a treatment regimen, the storage device 46 can also be used to store usage data. Continuous or periodic sensing allows the controller 34 to monitor how many hours a day the back brace is being used, at what tension, and whether the user has changed the tension away from the prescribed tension setting. This information can be sent to the physician so that the physician can monitor the patient's compliance with the prescribed treatment. This information can include a complete hour-by-hour history of the use of the brace, along with the associated tension.
The orthotic device 10 also includes a posture detection device 42 to automatically determine whether the patient is standing or sitting. In one embodiment, the posture detection device 42 is an accelerometer. The posture detection device 42 may communicate with the microprocessor 38 in the controller 34 to automatically set the orthotic device 10 to different tension settings when the patient is sitting and when the patient is standing.
With reference to
With reference to
The patient's personal computer 52 includes hardware, software, and/or firmware generally operative to (1) receive recorded data from the orthotic device 10; (2) store the recorded data; (3) transmit data over the wide area network to a physician's personal computer 56; (4) receive data over the wide area network from a physician's personal computer 56; and (5) transmit data to the orthotic device 10. The patient's personal computer 52 may comprise a computer-readable storage medium, such as a hard disk drive, a human interface device (“HID”) application programming interface (“API”), and a communication interface, such as a modem. The communication interface is coupled to the wide area network 54.
The wide area network 54 can be the Internet. Although
The physician's personal computer 56 includes hardware, software, and/or firmware generally operative to (1) receive data over the wide area network from a patient's personal computer 52; (2) store data; and (3) transmit data over the wide area network to a patient's personal computer 52 in order to program the orthotic device 10 with a certain tension prescription. The physician's personal computer may also be operative to receive data directly from and transmit data directly to the orthotic device 10 without the patient's computer, for example, if the patient were to make an in-office visit. The physician's personal computer 56 may comprise a computer-readable storage medium such as a hard disk drive, a human interface device (“HID”) application programming interface (“API”), and a communication interface, such as a modem. The communication interface is coupled to the wide area network 54.
With reference to
The data storage device and/or the memory may also store an operating system (not shown), such as Microsoft Windows 7, Linux, the IBM OS/2 operating system, the MAC OS, or the UNIX operating system. It will be appreciated that embodiments of the present invention may also be implemented on platforms and operating systems other than those mentioned. An embodiment of the present invention may be written using JAVA, C, C++ language, or other programming languages, possibly using object oriented programming methodology.
One skilled in the art will recognize that the computer system of
With reference to
The network connection tool 82 includes hardware, software, and/or firmware generally operative to connect the controller 34 to a network or a computer. This connection allows the automated orthotic device controller to transfer brace use data to the network and receive prescription data from the network.
The prescription request tool 84 includes hardware, software, and/or firmware generally operative to request prescription data from a physician's computer, either directly or over a network.
The prescription download tool 86 includes hardware, software, and/or firmware generally operative to download and store prescription data, which may be in the form of a treatment regimen, from a physician's computer.
The prescription selection tool 88 includes hardware, software, and/or firmware generally operative to select a prescribed tension setting from a treatment regimen which includes one or more prescribed tension settings. This may occur manually, with the user selecting when he or she would like to switch from one setting to the other, or it may occur automatically, with the prescribed tension setting being changed automatically after a certain amount of time or after a certain number of hours that the back brace has been used.
The prescription implementation tool 90 includes hardware, software, and/or firmware generally operative to implement a prescribed tension setting. In one embodiment, the prescription implementation tool implements a prescribed tension setting by sending electrical signals to the motor 22.
The brace use monitoring tool 92 includes hardware, software, and/or firmware generally operative to monitor the patient's use of the brace and to store the brace use data. The brace use data may include such information as an hour-by-hour account of the patient's use of the back brace and the tension setting of the brace during use. In one embodiment, the brace use monitoring tool monitors the patient's use of the brace by periodically checking the current consumption of the motor 22, which is directly proportional to the brace tension, and comparing it with what it should be in accordance with the last set tension, as described above.
The brace use data upload tool 94 includes hardware, software, and/or firmware generally operative to upload the brace use data from the controller 34 to the network. Uploading this data to the network may include uploading the brace use data to the user's computer, or to the physician's computer, or to some other computer or device on the network.
The brace use data upload site selection tool 96 includes hardware, software, and/or firmware generally operative to allow the user to select where on the network they would like to upload the brace use data. In one embodiment, the brace use data upload site selection tool allows the user to select a location on the network by displaying a menu of network location for selection by the user.
In one embodiment, the automated orthotic device with treatment regimen system 80 allows the automated orthotic device 10 to interface with the network by uploading the user's back brace use data and also by downloading the user's treatment regimen prescription information. This system allows the automated orthotic device 10 to receive and implement an entire treatment regimen whereby the prescribed tension setting may be changed as the user's condition changes without the user being required to make multiple visits to the physician's office. This system also allows the user to receive changes to his or her prescribed treatment regimen over a network so that he or she does not have to go to the physician's office to receive these changes.
With reference to
The automated orthotic device connection tool 102 includes hardware, software, and/or firmware generally operative to connect the user's PC to automated orthotic device 10. This connection allows the user's PC to transfer prescription data to the automated orthotic device 10 and receive brace use data from the automated orthotic device 10.
The network connection tool 104 includes hardware, software, and/or firmware generally operative to connect the user's PC to a network. This connection allows the user's PC to transfer brace use data to the network and receive prescription data from the network.
The brace use data request tool 106 includes hardware, software, and/or firmware generally operative to request brace use data from the controller 34 on the automated orthotic device 10.
The brace use data download tool 108 includes hardware, software, and/or firmware generally operative to download and store brace use data from the controller 34 on the automated orthotic device 10.
The brace use data upload tool 110 includes hardware, software, and/or firmware generally operative to upload brace use data that has been downloaded from the controller 34, to the physician's PC 56.
The prescription data request tool 112 includes hardware, software, and/or firmware generally operative to request prescription data from the physician's PC 56.
The prescription data download tool 114 includes hardware, software, and/or firmware generally operative to download and store prescription data from the physician's PC 56.
The prescription data upload tool 116 includes hardware, software, and/or firmware generally operative to upload prescription that has been downloaded from the physician's PC 56, to the controller 34 on the automated orthotic device 10.
In one implementation, the user PC automated orthotic device interface system allows the user PC 52 to act as a connection tool between the automated orthotic device 10 and the physician's PC 56. The user PC 52 receives brace use data from the automated orthotic device 10 and uploads that information to the physician's PC 56. The user PC 52 also receives prescription data from the physician's PC 56 and sends it to the automated orthotic device 10.
With reference to
The automated orthotic device connection tool 122 includes hardware, software, and/or firmware generally operative to connect the physician's PC to the automated orthotic device 10. This connection allows the physician's PC to transfer prescription data to the automated orthotic device 10 and receive brace use data from the automated orthotic device 10. This connection would occur when the user visits the physician's office and the physician is able to directly connect his or her computer to the user's automated orthotic device 10.
The network connection tool 124 includes hardware, software, and/or firmware generally operative to connect the physician's PC to a network. This connection allows the physician's PC to receive brace use data from the network and transfer prescription data to the network.
The brace use data request tool 126 includes hardware, software, and/or firmware generally operative to request brace use data from the network (e.g., request brace use data stored on the user's PC) or directly from the controller 34 on the automated orthotic device 10.
The brace use data download tool 128 includes hardware, software, and/or firmware generally operative to download and store, on the physician's PC, brace use data from the network (e.g., brace use data that was saved on the user's PC) or from the controller 34 on the automated orthotic device 10.
The prescription input tool 130 includes hardware, software, and/or firmware generally operative to allow the physician to input a treatment regimen or prescription into the physician's computer for transferring to the automated orthotic device 10.
The prescription data upload tool 132 includes hardware, software, and/or firmware generally operative to upload prescription data to the network or directly to the controller 34 on the automated orthotic device 10.
In one embodiment, the physician PC automated orthotic device interface system 120 allows the physician PC 56 to receive brace use data and to transmit prescription data. The brace use data may be received through a direct connection between the automated orthotic device 10 and the physician's PC 56, possibly through a USB cable connecting the two, or the data may be received over a network connection between the automated orthotic device 10 and the physician's PC 56. Prescription data may be transmitted from the physician's PC 56 to the automated orthotic device 10 in the same ways, through a direct connection or through a network connection.
With reference to
If there are multiple prescribed tension settings, then a single one is chosen to be applied according to the specified order in the treatment regimen. This selection occurs in step 208, and may be a step taken by the user through the controller 34 or a step performed automatically by the controller 34. In one embodiment, the controller 34 allows for the user to manually select which prescribed tension setting will be applied when. In another embodiment, the treatment regimen may automatically switch from a first prescribed tension setting to a second prescribed tension setting after the passage of a specified amount of time. In yet another embodiment, the prescribed tension setting may change after a certain number of hours of use of the orthotic device by the user, which, as was explained earlier, the controller 34 is able to keep track of when the back brace is being used through continuous or periodic sensing.
Once a prescribed tension setting is chosen, the controller tightens the orthotic device to the prescribed tension setting in step 210. In step 212, through continuous or periodic sensing, the brace is able to monitor when the brace is being used and at what tension, and in step 214, stores the brace use data. If there are multiple prescription settings in the treatment regimen, step 216 changes the prescribed tension setting in order to better suit the user's changing condition. As was described earlier, this change may be initiated by the user as he or she feels that his or her treatment is progressing, or it may occur automatically after the passage of a certain amount of time.
When the user wishes to communicate with his or her doctor without going into the physician's office, the user may move to step 218 and connect the automated orthotic device 10 to the network 50. In one embodiment, the user may also want to share his or her information with other network users, such as an insurance provider or other physicians on the network. At step 220, the user may specify where they want to upload the brace use data that is stored on controller 34 in the storage device 46. At step 222, brace use data is uploaded to the specified site.
If the user is connected to a physician's computer, the user or the physician may want to alter the treatment regimen. At step 224, the physician may transfer to the user's automated orthotic device 10 a revised treatment regimen, which would return the method to step 208 to choose a prescribed tension setting from the treatment regimen.
With reference to
If there are multiple prescribed tension settings, then a single one is chosen to be applied according to the specified order in the treatment regimen. This selection occurs in step 308, and may be a step taken by the user through the controller 34 or a step performed automatically by the controller 34. In one embodiment, the controller 34 allows for the user to manually select which prescribed tension setting will be applied when. In another embodiment, the treatment regimen may automatically switch from a first prescribed tension setting to a second prescribed tension setting after the passage of a specified amount of time. In yet another embodiment, the prescribed tension setting may change after a certain number of hours of use of the orthotic device by the user, which, as was explained earlier, the controller 34 is able to keep track of when the back brace is being used through continuous or periodic sensing.
Once a prescribed tension setting is chosen, the controller tightens the orthotic device to the prescribed tension setting in step 310. In one embodiment, each prescribed tension setting includes both a standing prescribed tension setting and a sitting prescribed tension setting, with each of these settings individually specified by the physician. In another embodiment, rather than having the patient's physician specify two different tensions for standing and sitting, the microprocessor calculates a sitting or standing tension using the physician-prescribed tension as a variable. In step 312, the posture detection device 42 monitors for any change in user posture or position. In one embodiment, the posture detection device 42 is an accelerometer. If no change in posture is detected, the automated orthotic device 10 continues to apply the current prescribed tension setting (e.g., the standing prescribed tension setting). When a change in posture occurs, the microprocessor 38 analyzes data from the posture detection device 42 to determine whether the user is now standing or sitting. Once the user's position is determined, the orthotic device 10 determines the appropriate prescribed tension setting at step 314, whether it is for standing or for sitting. Once the appropriate tension setting is determined, the method returns to step 310, where the tension setting is applied.
Although the invention has been disclosed with reference only to the presently preferred embodiments, those of ordinary skill in the art will appreciate that various modifications can be made without departing from the invention. Accordingly, the invention is defined only by the following claims.
This application claims priority from U.S. Provisional Patent Application No. 61/662,198, filed on 20 Jun. 2012, the contents of which are incorporated herein by reference in their entirety.
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