NONINVASIVE DIAGNOSTIC SYSTEM
A device for acquiring data and diagnosing a musculoskeletal injury. The device includes a semi-flexible housing, at least one ultrasonic transducer, a positional localizer, and a transmission system. The semi-flexible housing is positioned proximate a portion of the musculoskeletal system of a patient and supports the at least one ultrasonic transducer and the positional localizer. The at least one ultrasonic transducer is configured to acquire an ultrasonic data indicative of a bone surface. The positional localizer is positioned at a select location relative to the at least one ultrasonic transducer and tracks movement of the housing. The transmission system transmits the ultrasonic data of the at least one ultrasonic transducer and the movement data of the positional localizer to a data analyzer for analysis and diagnosis.
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The present application claims the filing benefit of co-pending PCT Patent Application No. PCT/US2010/022939, filed on Feb. 2, 2010, and is a Continuation-In-Part of co-pending U.S. patent application Ser. No. 12/364,267, filed on Feb. 2, 2009, the disclosures of both applications are hereby incorporated by reference herein in their entirety.
FIELD OF THE INVENTIONThe present invention relates to devices and methods for evaluating a physiological condition of a musculoskeletal system and, more particularly, to evaluating the physiological condition of bodily joints.
BACKGROUND OF THE INVENTIONIn humans, the knee joint 50, as shown in
Knee joint motions are stabilized primarily by five ligaments which restrict and regulate the relative motion between the femur 52, the tibia 54, and the patella 56. These ligaments are the anterior cruciate ligament (“ACL”) 58, the posterior cruciate ligament (“PCL”) 60, the medial collateral ligament (“MCL”) 62, the lateral collateral ligament (“LCL”) 64, and the patellar ligament 66. An injury to any one of these ligaments 58-66 or other soft-tissue structures may cause detectable changes in knee kinematics and the creation of detectable vibrations, each of which may be representative of the type of knee joint injury and/or the severity of the injury. These visual (knee kinematics) and auditory (vibrations) changes are produced as the bones 52, 54, 56 move in a distorted kinematic pattern and differ significantly from the look and sound of a properly balanced knee joint 50 moving through the same range and types of motion.
Conventionally, knee vibration has been detected using microphones with or without stethoscope equipment and correlated with clinical data regarding various joint problems. However, microphones and stethoscopes cannot reliably detect frequencies, especially those experiencing strong interference from noise. Also the signal clearance can be substantially be influenced by skin friction. It is desirable, therefore, to provide a diagnostic tool that compares patient specific data with kinematic data while providing visual feedback to clinicians.
SUMMARY OF THE INVENTIONWhile the present invention will be described in connection with certain embodiments, it will be understood that the present invention is not limited to these embodiments. To the contrary, this invention includes all alternatives, modifications, and equivalents as may be included within the spirit and scope of the present invention.
A device for acquiring data and diagnosing a musculoskeletal injury in accordance with one embodiment of the present invention includes a semi-flexible housing, at least one ultrasonic transducer, a positional localizer, and a transmission system. The semi-flexible housing is positioned proximate a portion of the musculoskeletal system of a patient and supports the at least one ultrasonic transducer and the positional localizer. The at least one ultrasonic transducer is configured to acquire an ultrasonic data indicative of a bone surface. The positional localizer is positioned at a select location relative to the at least one ultrasonic transducer and tracks movement of the housing. The transmission system transmits the ultrasonic data of the at least one ultrasonic transducer and the movement data of the positional localizer to a data analyzer for analysis and diagnosis.
Another embodiment of the present invention is directed to a method of diagnosing a musculoskeletal injury. The method includes creates a 3D model of a portion of the musculoskeletal system of a patient. A feature data is acquires by a sensor that is positioned proximate the portion of the musculoskeletal injury. The feature data is compared, by a neural network, to a database of feature data. A dataset within the database of feature data is representative of the musculoskeletal injury. Then, based on the comparing, a diagnosis is returned.
Still another embodiment of the present invention is directed to a diagnostic system for diagnosing a musculoskeletal injury. The system includes a 3D model reconstruction module that acquires a structural data indicative of a bone surface. The bone is within a portion of the musculoskeletal system of a patient. The 3D model reconstruction module constructs a patient-specific model from the structural data. The system further includes a kinematic tracking module that acquires movement data while the portion of the musculoskeletal system is articulated. A vibroarthography model acquires vibration data generated by the articulation. The structural data, the movement data, and the vibration data are received and analyzed by an intelligent diagnosis module in order to determine injury type.
The above and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
The exemplary embodiments of the present invention are illustrated and described below to encompass diagnosis of bodily abnormalities and, more particularly, devices and methods for evaluating the physiological condition of the musculoskeletal system (such as joints) to discern whether abnormalities exist and the extent of any abnormalities. Of course, it will be apparent to those of ordinary skill in the art that the exemplary embodiments discussed below are merely examples and may be reconfigured without departing from the scope and spirit of the present invention. However, for clarity and precision, the exemplary embodiments, as discussed below, may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present invention. By way of example, the exemplary embodiments disclosed herein are described with respect to diagnosing a knee joint injury. Nevertheless, the exemplary embodiments may be utilized to diagnose other injuries of the musculoskeletal system (such as a hip joint injury or a bone fracture), as the knee joint 50 (
Turning now to the figures and in particular to
It will be understood by those of skill in the art that the diagnosis system 82 is usable with or without the use of the VA module 88. For example, the present invention may be used to mathematically describe the relative motion of the bones 52, 54, 56 in the patient's knee joint 50 as such motion is tracked on a 3D-patient specific bone model. The bone model and motion may be compared with a database of mathematical descriptions of joint motion. The database could contain mathematical descriptions of healthy or clinically undesirable joint motion.
As will be discussed in more detail hereafter, the interaction between bodily tissue (e.g., bone against cartilage or bone against bone) in a dynamic environment creates certain vibrations that are indicative of the condition or state of health of the joint. Even the healthiest and youngest joints create vibrations. However, joints that exhibit degradation, whether through wear or injury, will exhibit vibrations that are much more pronounced and amplified as compared to those of a healthy joint. The VA module 88 with the diagnostic system 82 utilizes those sounds, such as vibrations, exhibited by the joint during a range of motion to diagnose the condition of the joint without requiring an invasive procedure or subjecting the patient to radiation.
Referring still to
Each accelerometer 120a, 120b, 120c is in communication with one or more signal conditioning circuits or electronics 122. The accelerometers 120a, 120b, 120c are operative to detect sound, specifically vibrations, and output the sound detected in the form of frequency data (measured in Hertz) to the conditioning circuits 122. This frequency data is processed by the conditioning circuits 122 and communicated to the computer 96 as digital frequency data. While the accelerometers 120a, 120b, 120c are generating frequency data, the conditioning circuits 122 may include a clock 123 to time stamp the frequency data generated. As will be discussed in more detail below, correlating the frequency data with the time stamp provides a constant against which all of the detected data can be compared on a relative scale.
The first accelerometer 120a on the medial side of the knee joint 50 detects vibrations generated primarily by the interactions between the medial condyle 110 (
With reference now to
The pressure sensors 130 may be arranged in a grid-shaped pattern on the insole 132, which may include a series of rows and columns. The pressure sensors 130 are exposed to the underside of a patient's foot so that the location and amplitude (or amount) of the contact forces applied by the foot to the shoe 134, by way of the insole 132, may be measured. As will be discussed in more detail hereafter, the location of the pressures and the relative amount of pressures provides information relevant to diagnosis of injury. For example, the detected pressures of a patient with a limp caused by a knee joint injury would differ from the detected pressures of a patient with a healthy knee joint and a normal gait.
In one embodiment, each sensor 130 may include a capacitor having a deformable dielectric between two electrode plates. Changes in the pressure applied to the plates cause a strain, or deformation, of the dielectric medium. Thus, a pressure applied to the capacitive sensor 130 changes the spacing between the plates and the measured capacitance. The capacitive sensors 130 are arrayed across the area of pressure measurement to provide discrete pressure data points corresponding to strains/deformation at the various locations of the array. These strains/deformations are used to find the stresses and thus the compressive forces and to calculate the output of pressure data having units of force per unit area and time (i.e., N/m sec).
The sensors 130 in the grid-shape enable positioning of each detected pressure from each of the sensors 130 relative to another sensor 130. The resultant data, which includes a two-dimensional map of the pressure sensors 130, is either stored on the computer 96 or stored locally with the sensors 130. The resulting data may be wirelessly transmitted to the computer 96 via a wireless transmitter 136, such as an ultra-wide band transmitter. Using the 2D map of the sensors 130 stored on the computer 96 in combination with the received sensor pressure data, the computer 96 is operative to generate data tying detected pressure to position, specifically the position of one pressure sensor 130 with respect to another.
By tying amounts of compressive force to its applied position, the foot module 92 provides data reflecting precisely what pressures are exerted at what location. In addition, the computer 96 may include an internal clock 97 to associate a time of which the pressure is applied with the pressure data generated by the pressure sensors 130. Accordingly, the diagnostic system 82 not only knows how much pressure was exerted and the location where the pressure was applied, but also has time data indicating the duration of the applied pressures. Again, by tying the pressure data generated by the pressure sensors 130 to time, the pressure data can be correlated with the sound data generated by the VA module 88 using a common time scale. As a result, the diagnostic system 82 may evaluate how pressures exhibited at the bottom of the foot change as a function of time, along with how the vibrational data changes during the same time.
In the illustrated embodiment, the A-mode ultrasound transducers are utilized to detect the interface between bone and the surrounding soft tissue so that the location of the bone surface may be determined. Because the operation of ultrasound transducers (including the A-mode ultrasound transducers) is well known to those skilled in the art, a detailed discussion of the operation of ultrasound transducers in general, and A-mode ultrasound transducers specifically, has been omitted only for purposes of brevity.
The ultrasound creation and positioning submodule 140 as shown in
One of the functions of the ultrasound creation and positioning submodule 140 is to generate an electrical signal that is representative of the ultrasonic wave detected by the transducers 150 as the wand 152 moves over the patient's epidermis, proximate the knee joint 50 (
The positioning devices 170 of the ultrasound creation and positioning submodule 140 are fixedly mounted to the wand 152 and may include any of a number of positioning devices 170. For example, the wand 152 may include one or more optical devices (as the positioning devices 170) that are configured to generate, detect, and/or reflect pulses of light. These pulses of light interact with a corresponding detector or light generator to discern the position of the wand 152, in 3D space, and with respect to a fixed or reference position. One such device includes a light detector configured to detect pulses of light emitted from light emitters having known positions. The light detector detects the light and sends a representative signal to the computer 96 or otherwise a controller (not shown) of the light detector. The computer 96 is also provided the time at which the light pulses were emitted by the optical devices 170. In this matter, the computer 96 determines the position of the wand 152 relative to the known positions of the detectors. Because the ultrasound transducer 150 and the optical devices 170 are fixedly mounted to the wand 152, the position of the ultrasound transducers 150 with respect to the position of the optical devices 170 is known. Similarly, because the ultrasound transducers 150 are generating signals representative of the straight line distance between the transducers 150 and the bone-tissue interface, and the position of the transducers 150 with respect to the optical devices 170 is known, the position of the bone-tissue interface with respect to the optical devices 170 may be determined. In other words, as the wand 152 moves over the patient's epidermis, the optical devices 170 generate data that is determined, by the computer 96, to represent that the relative position of the optical devices 170 with respect to the light detectors has changed in the 3D coordinate system. This change in the position of the optical devices 170 may be easily correlated to the position of the bone-tissue interface, in 3D, because the position of the bone-tissue interface relative to the ultrasound transducers 150, as well as the position of the optical devices 170 with respect to the ultrasound transducers 150 are known. Accordingly, the 3D position data may be used in combination with the fixed position data (distance data for the position of the ultrasound transducers 150 with respect to the optical devices 170) for the ultrasound transducers 150 in combination with the distance data generated in response to the signals received from the ultrasound transducers 150 to generate composite data. The composite data may, in turn, be used to create a plurality of 3D points representing a plurality of distinct points on the surface of the bone, along the bone-tissue interface. As will be discussed in more detail below, these 3D points are utilized in conjunction with a default bone model to generate a virtual, 3D representation of the patient's bone.
Alternatively, the positioning devices 170 may comprise one or more inertial measurement units (“IMUs”). IMUs are known to those skilled in the art and include accelerometers, gyroscopes, and magnetometers that work together to determine the position of the IMUs in a 3D coordinate system. Because the A-mode ultrasound transducer 150 and the IMUs 170 are fixedly mounted to the wand 152, the position of the ultrasound transducers 150 with respect to the position of the IMUs 170 is known. Similarly, because the ultrasound transducers 150 are generating signals representative of the straight line distance between the transducers 150 and the bone-tissue interface and the position of the transducers 150 with respect to the IMUs 170 is known, the position of the bone-tissue interface with respect of the IMUs 170 may be determined. In other words, as the wand 152 moves over the patient's epidermis, the IMUs 170 generate data that is determined, by the computer 96, to represent that the relative position of the IMUs 170 has changed in the 3D coordinate system. This change in the position of the IMUs 170 may be easily correlated to the position of the bone-tissue interface in 3D because the position of the bone tissue interface relative to the ultrasound transducer 150 is known, as is also the position of the IMUs 170 with respect to the ultrasound transducers 150. Accordingly, the 3D position data may be used in combination with the fixed position data (distance data for the position of the ultrasound transducers 150 with respect to the IMUs 170) for the ultrasound transducers 150 in combination with the distance data generated in response to the signals received from the ultrasound transducers 150 to generate the composite data as described above.
Referring now also to
The UWB receiver 172 architecture in accordance with one embodiment is shown in
Each UWB transmitter 170 and receiver 172 is in communication with the computer 96. Accordingly, the computer 96 detects each time the UWB transmitter 170 transmits a UWB signal, as well as the time at which the UWB signal was transmitted. Similarly, the computer 96 detects the position of each of the UWB receivers 172 in the 3D coordinate system, as well as the time at which the UWB signal was received. The final time-difference-of-arrival (“TDOA”) calculation, via a UWB positioning system 183, is shown in
Referring now to
Because the A-mode ultrasound transducers 150 and the UWB transmitters 170 are fixedly mounted to the wand 152, the position of the ultrasound transducers 150 with respect to the position of the UWB transmitters 170 is known. Similarly, because the ultrasound transducers 150 are generating signals representative of the straight line distance between the ultrasound transducers 150 and the bone-tissue interface and the position of the ultrasound transducers 150 with respect to the UWB transmitters 170 is known, the position of the bone-tissue interface with respect to the UWB transmitter 170 may be determined. In other words, as wand 152 moves over the patient's epidermis, the UWB transmitters 170 transmit UWB signals that are correspondingly received by the UWB receivers 172. These UWB signals are processed by the computer 96 in order to discern whether the relative position of the UWB transmitters 170 has changed in the 3D coordinate systems, as well as the extent of such a change. This change in 3D position of the UWB transmitters 170 can be easily correlated to the position of the bone-tissue interface in 3D because the position of the bone relative to the ultrasound transducer 150 and the position of the UWB transmitters 170 with respect to the ultrasound transducer 150 are known. Accordingly, the UWB 3D position data may be used in combination with the fixed position data (distance data for the position of the ultrasound transducers 150) to generate the composite data as described above.
Regardless of the positioning device 170 utilized with the ultrasound creation and positioning submodule 140, the wand 152 is repositioned over the skin of the patient, proximate to the knee joint 50 (
In order to power the devices on-board the wand 152, an internal power supply (not shown) may be provided. In one embodiment, the internal power supply comprises one or more rechargeable batteries.
Transformation is needed for transforming the position data from a reference coordinate frame of reference to a world frame of reference. According to one embodiment of the present invention, a linear movement of the ultrasound transducer 150 may be described:
v(n+1)=v(n)+a(n)dt Equation 1
s(n+t)=s(n)+v(n)dt=0.5a(n)dt2 Equation 2
where s(n+1) is the position of the ultrasound transducer 150 at a current state, s(n) is the position from a previous state, v(n+1) is the instantaneous velocity of the current state, v(n) is the velocity from previous state, a(n) is the detected acceleration, and dt is the sampling time interval. The previous equations describe the dynamic motion and positioning of a point in 3D Euclidean space. Additional information is needed to describe 3D orientation and motion.
The orientation of the ultrasound transducer 150 may be described by using a gravity-based accelerometer (for example ADXL-330, analog device) and extracting the tilting information from each of a pair of orthogonal axes. The acceleration output on each of the x-, y-, or z-axes is due to gravity and is equal to the following:
Ai=(Voutx−Voff)=S Equation 3
where Ai is the acceleration of the ultrasound transducer 150 along each of the x-, y-, or z-axes, Voutx is the voltage output on each of the x-, y-, or z-axes, Voff is the offset voltage, and S is the sensitivity of the accelerometer. The yaw, pitch, and roll may be thus calculated as:
where pitch is ρ (the x-axis relative to the ground), roll is φ (the y-axis relative to the ground) and roll is θ (the z-axis relative to the ground). Since the accelerometer is gravity-based, the orientation does not require information from the previous state once the accelerometer is calibrated. The static calibration requires the resultant sum of accelerations from each of the three axes to equal 1−g (where g is the nominal acceleration due to gravity at the Earth's surface at sea level, defined to be precisely 9.80665 m/s2 (approximately 32,174 ft/s2)). Alternatively, an orientation sensor that provides yaw, pitch and roll information of the bodily tissue in question may be used. One such orientation sensor may be the commercially-available model IDG-300 from InvenSense (Sunnyvale, Calif.). The orientation of the ultrasound transducer 150 may then be resolved by using, for example, a direction cosine matrix transformation:
X2CθCφCθCφSp−SθCpCθSφCp−SθSpX1
Y2=SθCφSθSφSp−CθCpSθSφCp−CθSpY1 Equation 7
Z2−SφCφSpCθCp
where C represents cosine and S represents sine.
Referring again to
Before the patient data is acquired, software residing on the computer 96 may request a series of inputs from the user to adapt the diagnostic system 82 to equipment specific devices and the particular portion of the musculoskeletal anatomy to be modeled. For example, a menu 204 on a user interface 206 may be presented for the user to select the type of digitizer, which may include, without limitation, ultrasound. After the type of digitizer is selected, the user may actuate buttons 205a, 205b to connect to or disconnect from the digitizer, respectively.
As wand 152 moves over the patient's epidermis, the set of points is generated, numerically recorded, viewable in a data window 210, and ultimately utilized by the software to conform a selected bone model to the patient's actual bone shape. Consequently, the wand 152 is repositioned over the bones (the distal femur 52, the patella 56, the proximal tibia 54) for approximately 30 seconds so that the discrete points to typify the topography of the bone. Repositioning the wand 152 over the bone in question for a longer duration results in more 3D points being generated increases the resolution and improves the accuracy of the patient-specific bone model. A partial range of motion of the knee joint 50 (
Before, during, or after the ultrasound data is acquired, the software provides various drop-down menus allowing the software to load a bone model 208 that is roughly the same shape as the patient's bone. The computer 96 receives the ultrasound data, the computer 96 includes software that interprets the A-mode ultrasound transducer data and constructs a 3D map having discrete 3D points corresponding to points on the surface of the scanned bone. That is, the shape of the patient's bone is reconstructed in virtual space, using a set of points outlining the surface of the patient's bone as acquired by the tracked ultrasound transducer 150 (
More specifically, the computer 96 may include a database having a plurality of bone models of various portions of the musculoskeletal system, for example, the femur 52, the tibia, 54, and the patella 56, that are classified and selectable in a menu 212, for example based upon ethnicity, gender, height ranges, the side of the body, and so forth. Each of these classifications is accounted for in a drop-down menu of the software so that the model initially chose by the software most closely approximates the body of the patient.
For mapping each bone, the computer 96 uses either a default bone model or the selected bone model as a starting point to construction of the ultimate patient-specific, virtual bone model. The default bone model may be a generalized average, as the morphing algorithms use statistical knowledge of a wide database population of bones for a very accurate model. The selected bone model expedites computation. For example, in the case of generating a patient-specific model of the femur 52 where the patient is a 53 year old, Caucasian male, who is six feet tall, a default femoral bone model is selected based upon the classification of Caucasian males having an age between 50-60, and a height ranging from 5′10″ to 6′2″. In this manner, selection of the appropriate default bone model more quickly achieves an accurate patient-specific, virtual bone model because of the number of iterations between the patient's actual bone (typified by the 3D map of bone points) and the default bone model are reduced. Nevertheless, in view of the model bones taking into account numerous traits of the patient (ethnicity, gender, bone modeled, and body side of the bone), it is quite possible to construct an accurate patient-specific 3D model with as few as 150 data points comprising the set which typically may be acquired by repositioning the wand 152 over the bone for 30 seconds for each bone. Ultrasound will not be affected whether the patient has a prosthetic implant.
After the appropriate bone model is selected, the computer 96 superimposes the 3D points onto the default bone model and, thereafter, carries out a deformation process so that the bone model exhibits the 3D bone points detected during the signal acquisition. The deformation process also makes use of statistical knowledge of the bone shape based upon reference bones of a wide population. After the deformation process is complete, the resulting bone model is a patient-specific, virtual 3D model of the patient's actual bone. The foregoing process is repeated for each bone comprising the specific joint to create patient-specific, virtual 3D models of the patient's anatomy.
Referring back to
Turning specifically to
Each ultrasound transducer 222 is tracked using an accelerometer or a sensor-specific localizer (or any other appropriate inertial sensor). The tracking may then be used to generate localized bone points from the outputs of the ultrasound transducers 222 and to virtually display bone movement on the 3D model while the knee joint 50 (
Referring to
Alternatively, the positioning devices 224 may be comprised of one or more IMUs. Because the ultrasound transducers 222 and the IMUs 224 are fixedly mounted to the knee brace 220, the relative positions between the ultrasound transducers 222 and the IMUs 224 are known. Similarly, because the ultrasound transducers 222 are generating signals representative of the straight line distance between the transducer 222 and the bone-tissue interface, and the position of the transducers 222 with respect to the IMUs 224 is known, the position of the bone with respect to the IMUs 224 may be easily determined. In other words, as the knee joint 50 (
As was described previously with respect to the wand 152, the positioning devices 224 of the brace 220 may alternatively be comprised of one or more ultra wide band (UWB) transmitters. In that regard, one or more UWB transmitters 224 are fixedly mounted to the brace 220 and operable to transmit sequential UWB signals to three or more UWB receivers (not shown) having known positions in the 3D coordinate system. Each UWB transmitter 224 is in communication with the computer 96, as are the plurality of UWB receivers (not shown). Accordingly, the computer 96 detects each time the UWB transmitter transmits a UWB signal, as well as the time at which the UWB signal was transmitted. Similarly, the computer 96 detects the position of each of the UWB receivers (not shown) in the 3D coordinate system, as well as the time at which the UWB signal was received. The computer 96 may then use the custom digital signal processing algorithms to accurately locate the leading-edge of the received UWB pulse based on the position of each UWB receiver (not shown), the time when each UWB signal was received, and the time that the UWB signal was transmitted. The position may then be determined by the TDOA calculation as was described with reference to
In order to communicate information from the submodules 142, 144 to the computer 96, the brace 220 may include a transmitter 228, such as a UWB transmitter, in communication with the ultrasound transducer 222 to facilitate wireless communication of data to the computer 96. It should be noted that if UWB transmitter 228 is also utilized as the positioning devices 224, a dedicated transmitter 228 is unnecessary as the UWB transmitters 224 could function to also send ultrasound data directly to the computer 96 over a wireless link.
It should be understood that use of the transmitter 228 and a field programmable gate array design enables the computations to be cammed out on a real-time basis. For example, as patient's knee joint 50 (
Referencing
Referring now to
A tracking module 262 such as an inertia-based localizer is mounted to the transducer 250 to track its motion. As the transducer 250 rotates within the inner circumference 256 of the sub-brace 249, it collects data as to the bone-tissue interface. By using a single transducer 250, the RT approach includes the advantage of lower cost than the stationary transducer designs and higher accuracy due to the greater number of localized bone surface points for each tracking step, while maintain a mechanical flexibility.
Referring to
In
Referring now to
Referencing
Referring to
With reference now to
Implementation of the method 316 includes joint movement visualization via the 3D model reconstruction with A-mode ultrasound system, as described previously. The method 316 also measures the vibrations produced to accurately localize the vibrational center and to determine the cause of the vibrations' occurrence.
Interpretation of the vibration and kinematic data is a complicated task involving an in-depth understanding of data acquisition, training data sets, signal analysis, as well as the mechanical system characteristics. Vibrations generated through the interactions of implant components, bones, and/or soft tissues result from induced by driving force leading to a dynamic response. The driving force may be associated with knee-ligament instability, bone properties, and conditions. A normal intact knee joint 50 (
The first stage includes acquisition of kinematic feature vectors, using multiple physiological measurements taken from the patient while the patient moves the knee joint 50 (
Feature vectors may also include the femoral position with respect to the tibia which is defined by three Euler angles 340, three translation components with the vibrational signal 342, and force data 344. Examples of these vectors are shown in
Fluoroscopy data 333 may be used to calculate the kinematics. While fluoroscopy data 333 is highly accurate, it requires the patient to remain within the small working volume of the fluoroscope unit and subjects the patient to ionizing radiation for a prolonged period of time. For most dynamic activities where the joints are loaded, such as running, jumping, or other dynamic activities, fluoroscopy is an unacceptable alternative. Therefore, use of fluoroscopy data 333 is not required.
It should further be noted that electromyography (“EMG”) electrodes 337 (
Once the neural network 98 (
Referring again to
Although now shown, some embodiments of the method may be adapted so that the testing set 327 is acquired outside of a clinical setting. For example, a knee brace in accordance with an embodiment of the present invention may be worn by a patient for an extended period of time while performing normal activities. For example, the patient may wear a device incorporating components of at least one of the JKT module 86 (
Data may be stored on a portable hard drive (or any other portable storage device) and then may be downloaded to exemplary systems for analysis. The data can be wirelessly transmitted and stored in a computer. It can also be stored with a miniature memory drive if field data is desired. If the occurrence of the pain is more random, some embodiments of the devices may continuously acquire data. Although, continuously monitoring devices may require a larger data storage capacity.
It is understood that while the exemplary embodiments have been described herein with respect to the knee joint 50 (
While the present invention has been illustrated by a description of various embodiments, and while these embodiments have been described in some detail, they are not intended to restrict or in any way limit the scope of the disclosed invention. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the present invention may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of the present invention, along with methods of practicing the present invention as currently known.
Claims
1. A device for acquiring data and diagnosing a musculoskeletal injury, the device comprising:
- a semi-flexible housing configured to be positioned proximate a portion of the musculoskeletal system of a patient;
- at least one ultrasonic transducer operably coupled to the housing and configured to acquire an ultrasonic data indicative of a bone surface;
- a positional localizer operably coupled to the housing at a select location relative to the at least one ultrasonic transducer, the positional localizer configured to track movement of the housing; and
- a transmission system operably coupled to the housing and configured to transmit the ultrasonic data from the at least one ultrasonic transducer and the movement data from the positional localizer to a data analyzer for analysis and diagnosis.
2. The device of claim 1, wherein the device is a brace configured to surround the portion of the musculoskeletal system for diagnosis.
3. The device of claim 2, wherein the brace is a knee brace for diagnosing a knee injury, the knee brace further comprising:
- a first ultrasonic transducer positioned proximate the distal femur; and
- a second ultrasonic transducer positioned proximate the proximal tibia.
4. The device of claim 3, wherein the first ultrasonic transducer, the second ultrasonic transducer, or both is comprised of an individual transducer tracking unit.
5. The device of claim 3, wherein the first ultrasonic transducer, the second ultrasonic transducer, or both is comprised of an inter-transducer mechanical link unit.
6. The device of claim 3, wherein the first ultrasonic transducer, the second ultrasonic transducer, or both is comprised of a rotating transducer unit.
7. The device of claim 1, wherein the positional localizer is an optical sensor device, an inertial measurement unit device, an ultra-wide band sensor device, or a combination thereof.
8. The device of claim 1, further comprising:
- a vibrational sensor operably coupled to the housing and configured to acquire a vibration signal generated during movement of the portion of the musculoskeletal system.
9. The device of claim 8, wherein the vibrational sensor comprises at least one accelerometer.
10. A method of diagnosing a musculoskeletal injury, the method comprising:
- creating a 3D model of a portion of the musculoskeletal system of a patient;
- acquiring a feature data with a sensor positioned proximate the portion of the musculoskeletal system while the portion is articulated;
- comparing, with a neural network, the acquired feature data with a database of feature data, wherein the database of feature data includes a dataset representative of the musculoskeletal injury; and
- returning a diagnosis based on the comparing.
11. The method of claim 10, further comprising:
- positioning a sensor proximate the portion of the musculoskeletal system;
- operating the sensor to acquire the feature data; and
- transferring the acquired feature data to the neural network.
12. The method of claim 11, wherein the sensor is an ultrasound transducer and the feature data includes an ultrasonic signal indicative of a bone surface, the method further comprising:
- tracking a position of the ultrasound transducer relative to the portion of the musculoskeletal system.
13. The method of claim 10, where creating a 3D model further comprises:
- acquiring structural data indicative of a surface of a bone within the portion of the musculoskeletal system; and
- morphing a general bone model in accordance with the structural data.
14. The method of claim 13, wherein the structural data includes an ultrasonic signal, a computerized tomography data, a fluoroscopy data, or a combination thereof.
15. The method of claim 10, wherein the feature data includes a vibrational data, a kinematic data, a contact force data, or a combination thereof.
16. The method of claim 15, wherein the feature data comprises the vibrational data and the kinematic data, the vibrational data being time-synchronized with the kinematic data.
17. The method of claim 10, wherein comparing the acquired feature data further comprises:
- training the neural network with a plurality of datasets, wherein at least one of the plurality of datasets is the dataset representative of the musculoskeletal injury.
18. The method of claim 10, wherein the feature data includes a shear measurement, at least one Euler angle, a translational component, a force data, or a combination thereof.
19. The method of claim 10, further comprising:
- displaying the returned diagnosis, the 3D model, the acquired feature data, or a combination thereof on a user interface.
20. A diagnostic system for diagnosing a musculoskeletal injury, the diagnostic system comprising:
- a 3D model reconstruction module configured to acquire a structural data indicative of a bone surface within a portion of the musculoskeletal system of a patient and to construct a patient-specific model from the structural data;
- a kinematics tracking module configured to acquire a movement data while the portion of the musculoskeletal system is articulated;
- a vibroarthography module configured to acquire a vibration data generated during the articulation; and
- an intelligent diagnosis module configured to receive and analyze the structural data, the movement data, and the vibration data and to determine an injury type from the analysis.
21. The diagnostic system of claim 20, wherein the 3D model reconstruction module further comprises:
- an ultrasound transducer configured to acquire an ultrasonic signal indicative of the bone surface;
- a position sensor having a select location relative to the ultrasound transducer, the position sensor configured to track movement of the portion of the musculoskeletal system; and
- a statistical bone atlas comprising a plurality of bone models, wherein at least one of the plurality of bone models is morphed in accordance with the ultrasonic signal.
22. The diagnostic system of claim 20, wherein the kinematics tracking module further comprises:
- a brace configured to be positioned proximate the portion of the musculoskeletal system;
- at least one ultrasonic transducer operably coupled to the brace and configured to acquire an ultrasonic data indicative of the bone surface;
- a positional localizer operably coupled to the brace at a select location relative to the at least one ultrasonic transducer, the positional localizer configured to track movement of the brace; and
- a transmission system operably coupled to the brace and configured to transmit the ultrasonic data from the at least one ultrasonic transducer and the movement data from the positional localizer to the intelligent diagnosis module.
23. The diagnostic system of claim 20, wherein the vibroarthography module further comprises:
- at least one vibrational sensor positioned proximate the portion of the musculoskeletal system; and
- a transmission system configured to transmit the vibration data from the at least one vibrational sensor to the intelligent diagnosis module.
24. The diagnostic system of claim 20, wherein the intelligent diagnosis module further comprises:
- a neural network configured to compare the movement data, the vibration data, or both to a database comprising of movement, vibrational, and injury data, wherein the database includes the movement data or the vibration data and an associated musculoskeletal injury type;
- at least one transformation configured to transfer an acquired data to a virtual data; and
- a statistical atlas comprising a plurality of bone models, wherein at least one of the plurality of bone models is morphed in accordance with the structural data to construct the patient-specific model.
25. The diagnostic system of claim 20, further comprising:
- a contact force module configured to acquire a pressure data while the portion of the musculoskeletal system is articulated.
26. The diagnostic system of claim 25, wherein the contract for module comprises:
- a shoe insole configured to be positioned on a foot of a patient;
- a plurality of pressure sensors operably coupled to the shoe insole and arranged in a pattern; and
- a transmission system operably coupled to the shoe insole and configured to transmit the pressure data from the plurality of pressure sensors to the intelligent diagnosis module.
Type: Application
Filed: Aug 2, 2011
Publication Date: Feb 2, 2012
Applicant: Joint Vue, LLC (Columbus, OH)
Inventors: Mohamed R. Mahfouz (Knoxville, TN), Ray C. Wasielewski (New Albany, OH), Richard Komistek (Knoxville, TN)
Application Number: 13/196,701
International Classification: A61B 8/00 (20060101); A61B 6/03 (20060101); A61B 5/11 (20060101); A61B 5/103 (20060101); A61B 5/00 (20060101); A61B 8/13 (20060101);