Claims:1. A wearable multifunctional knee brace system with integrated continuous passive mobilization, comprising:

a knee support assembly detachably supports a leg and a knee joint of a user;

a motor assembly configured to control the knee support assembly and deliver continuous passive mobilization to the knee joint, and

a biofeedback interface in communication with an array of sensors and knee support assembly configured to provide continuous real-time feedback to encourage the user to perform mobilization exercises.

2. The system of claim 1, wherein the knee support assembly comprises a brace assembly incorporated with the array of sensors.

3. The system of claim 1, wherein the brace assembly comprises a pair of upper brace member and a lower brace member.

4. The system of claim 1, wherein the pair of upper brace member is secured to the upper leg or thigh of the user.

5. The system of claim 1, wherein the pair of lower brace member is secured to the lower legs.

6. The system of claim 1, wherein the brace assembly further comprises an addition band attached to a proximal end of the knee support assembly.

7. The system of claim 1, wherein the knee support assembly comprises one or more lightweight rods to provide mechanical stability to the knee joint.

8. The system of claim 1, wherein the knee support assembly comprises a goniometer incorporated at one end of at least one rod configured to monitor and estimate the degree of movement at the knee joint.

9. The system of claim 1, wherein the knee support assembly comprises at least two strings controllable by the motor assembly to deliver continuous passive mobilization to the knee joint.

10. The system of claim 1, wherein the array of sensors and goniometer are configured to track the range of motion and muscle activity around the knee joint.

11. The system of claim 1, wherein the array of sensors includes electromyography (EMG) sensors and inertial sensors.

12. The system of claim 11, wherein the inertial sensors include proximity sensors and accelerometer sensors.

13. The system of claim 1, wherein the motor assembly is a servo motor assembly.

14. The system of claim 1, wherein the motor assembly is a thread motor assembly. , Description:WEARABLE MULTIFUNCTIONAL KNEE BRACE SYSTEM WITH INTEGRATED CONTINUOUS PASSIVE MOBILIZATION
CROSS REFERENCE TO RELATED APPLICATION
The present application claims the benefit of the priority of Indian Provisional Patent Application 202041031771 for “WEARABLE MULTIFUNCTIONAL KNEE BRACE SYSTEM WITH INTEGRATED CONTINUOUS PASSIVE MOBILIZATION”, filed on July 24, 2020, the contents of which is hereby incorporated by reference. The specification of the above referenced patent application is incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
A. Technical field
[0001] The present invention generally relates to the knee care system for the treatment of knee joints affected by osteoarthritic type disorders. More specifically, the present invention relates to a wearable multifunctional knee brace system with integrated continuous passive mobilization configured to detachably support a leg and a knee joint of a user/patient.

B. Description of related art
[0002] According to the Agency for Healthcare Research and Quality, more than 600,000 knee replacements are performed each year in the United States and 120,000 knee surgeries in India. Knee replacement, also called knee arthroplasty is a surgical procedure to resurface a knee damaged by arthritis. It can increase mobility and decrease pain in people who have arthritic knee joints. The most common indications for total knee replacement globally are osteoarthritis, rheumatoid arthritis, and secondary degenerative arthritis. More than 90 percent of patients who have knee replacement surgery experience less pain and greater mobility in their knee after the procedure. However, to regain functional independence and the aforementioned recovery, well-executed rehabilitation is necessary.

[0003] The rehabilitation team including the physiotherapists helps the patients maintain and maximize their strength, function, movement of the knee through various supervised rehabilitation protocols. In addition to the patients undergoing total knee arthroplasty, there are numerous other conditions affecting knee joints that require specialized and supervised intervention by the rehabilitation team for recovery. These conditions include osteoarthritis, rheumatoid arthritis, secondary degenerative arthritis, post-traumatic stiffness, postoperative (surgeries for other causes like fractures) stiffness, sports injuries, various causes of muscle weakness/ atrophy, etc. Stiffness of the joint along with muscle weakness are the biomechanical abnormalities manifested in all the above conditions. Well performed supervised rehabilitation protocols are an integral part of the treatment for these conditions. These rehabilitation protocols and exercises are intended to strengthen the leg muscles and to restore knee movement. These protocols ideally need supervised sessions daily for several weeks or months depending on the underlying pathology and rate of recovery. The exercises mainly focus on muscle strengthening (quadriceps and hamstrings) and to regain the knee range of movement.

[0004] In addition to these active exercise protocols, passive mobilization of the knee also has a significant role in knee rehabilitation for various conditions mentioned before. Usually, the passive exercise is performed on a Continuous Passive Motion (CPM) machine. It is highly useful following various surgical procedures of the knee including total knee arthroplasty and also various other pathologies mentioned before. It is a device that moves the joint slowly in a “pump effect” while the patient is in bed. This restores mobility and decreases postoperative hemarthrosis and edema to obtain good quality collagenous healing of the operative wound. Continuous Passive Motion helps in pain management, early flexion, reduces swelling, and decreases the length of hospital stay after surgery. To undergo this rehabilitation method using the CPM machine, patients would either have to get inpatient care or have to pay daily visits to the rehabilitation center. Each health care facility (hospital) would contain a maximum of one or two CPM machines commonly. Due to this relative demand on the CPM machine, each patient would be allotted time slots for the utilization of the same.

[0005] Further, most of the existing CPM machine designs aim to deliver a single function- continuous passive mobilization. Provision for continuous biofeedback to aid active mobilization or for isometric muscle strengthening exercises is not provided. Other major disadvantages of the existing CPM machines include cost and bulky construct of the machine. These drawbacks make the current system of CPM machines available at the institution level (hospitals/ rehabilitation centers), thereby forcing the user/ patient to get admitted to the institution or to pay frequent daily visits. Hence a better technology is ideal that could provide continuous passive mobilization to the joint when the patient is at home and through multiple sessions in a day. Few existing patent references attempted to address the aforementioned problems are explained as follows.

[0006] A prior art US10182957 of Chetlapalli; Janaki Ram-srinivasa Rao entitled “continuous passive motion device” discloses a CPM device including a support structure arranged to be removably attached to an articulating brace supporting a limb and a joint of a user. One or more rotating members are rotatably connected to the support structure. The rotating members are adapted to contact and roll on an underlying surface that is separate from the CPM device. At least one motor is arranged to apply a torque to the rotating members such that the rotating members roll on the underlying surface. The rolling of the rotating members on the underlying surface causes the support structure to translate over the underlying surface, which, in turn, conveys a bending force to the joint. However, the Chetlapalli reference provides CPM to the knee joint only when the user is lying on a platform/bed.

[0007] Another prior art WO2017035573 of Coolican Myles Raphael James entitled “multifunctional cooling and compression with reporting, analysis, and feedback” discloses a method and an apparatus for rehabilitation of a patient that provides a performance target to the patient, senses a performance indicator corresponding to the performance target, then analyses a difference between the performance target and the performance indicator. The performance target may then be revised in response to the analysis. The apparatus also provides visual feedback, verbal feedback, and/or other encouragement strategies for the patient to work towards achieving target(s). Further, the apparatus also initiates a clinical decision tool review of pain control and/or use of psychological coping strategies by the patient. However, the “Raphael James” lacks to provide a portable physiotherapy assistive device that provides a patient with an alternative option to exercise in the comfort of home without visiting a rehabilitation center frequently.

[0008] Therefore, there is a need for a wearable CPM system having a basic structure of a knee brace incorporated with (i) an array of sensors to track various biomechanical aspects around the knee joint (range of motion, muscle activity), (ii) a low-profile CPM delivery assembly and (iii) a real-time biofeedback channels for an end-to-end communication and also for better patient compliance.

SUMMARY OF THE INVENTION
[0009] The present invention discloses a therapeutic knee brace system or a wearable multifunctional knee brace system. Also, the present invention discloses a wearable multifunctional knee brace system (hereinafter referred as system) integrated with continuous passive mobilization. The system comprises a knee support assembly configured to detachably support a leg and a knee joint of a user/patient.

[0010] In one embodiment, the knee support assembly comprises a brace assembly having a pair of upper brace member and a pair of lower brace member. In one embodiment, the knee support assembly further comprises an additional band. The additional band is attached to the knee support assembly at the proximal end, which supports a servomotor and wraps around the hip of the patient. In one embodiment, the additional band is configured to keep the knee support assembly stays in position while performing Continuous Passive Motion (CPM). The knee support assembly further comprises one or more leg support rods. In one embodiment, the one or more leg support rods include an upper leg support and a lower leg support. In one embodiment, the leg supports are lightweight rods configured to provide mechanical stability to the knee joint. The knee support assembly further comprises a digital goniometer incorporated at one end of at least one leg support rod. The digital goniometer is configured to estimate the degree of movement at the knee joint. In one embodiment, the array of sensors is configured to monitor the active as well as passive exercises performed by the user.

[0011] In one embodiment, the knee support assembly further comprises a motor assembly to control the knee support assembly and deliver continuous passive mobilization to the knee joint. In one embodiment, the motor assembly comprises a servo motor assembly. The motor assembly is configured to deliver the function of continuous passive mobilization at the knee joint. In one embodiment, the knee support assembly further comprises an array of sensors incorporated into the brace assembly. In one embodiment, the array of sensors includes electromyography (EMG) sensors and inertial sensors. In one embodiment, the inertial sensors include proximity sensors and accelerometer sensors.

[0012] In one embodiment, the system further comprises a track assembly configured to support the leg of the user. The foot of the user would be seated in the slot provided at the distal aspect of the track and the wheels and rail mechanism would provide smooth sliding movement of the limb on the rail during the passive mobilization of the knee.

[0013] In another embodiment, the knee support assembly further comprises at least two pairs of strings having high tensile strength. The at least two strings are disposed at the knee support assembly such that the strings lie on the front and rear side of the limb. In one embodiment, the motor assembly comprises a thread motor assembly. The strings are lengthened and shortened using the motor assembly thus providing continuous passive mobilization. The motor assembly could be pre-programmed to suit the group of muscles that have to contracted/activated by the user.

[0014] In one embodiment, the system further comprises a biofeedback interface in communication with an array of sensors and knee support assembly. The interface allows a health care provider and the user to communicate and provide continuous real-time feedback to encourage the user to perform mobilization exercises. In one embodiment, the interface could be a mobile application or augmented reality (AR)/ virtual reality (VR) gear. In one embodiment, the interface could be used as a real-time biofeedback platform to encourage patients to perform the mobilization exercises as per the protocols advised by the health care team.

[0015] Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
BRIEF DESCRIPTION OF DRAWINGS
[0016] The foregoing summary, as well as the following detailed description of the invention, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, exemplary constructions of the invention are shown in the drawings. However, the invention is not limited to the specific methods and structures disclosed herein. The description of a method step or a structure referenced by a numeral in a drawing is applicable to the description of that method step or structure shown by that same numeral in any subsequent drawing herein.

[0017] FIG. 1 exemplarily illustrates a front view of a knee support assembly, according to an embodiment of the present invention.

[0018] FIG. 2 exemplarily illustrates a rear view of the knee support assembly, according to an embodiment of the present invention.

[0019] FIG. 3 exemplarily illustrates an inner aspect of the knee support assembly showing various sensors, according to an embodiment of the present invention.

[0020] FIG. 4 exemplarily illustrates a right-side view of the knee support assembly, according to one embodiment of the present invention.

[0021] FIG. 5 exemplarily illustrates a left side view of the knee support assembly, according to one embodiment of the present invention.

[0022] FIG. 6 exemplarily illustrates the knee support assembly with an attachable telescopic track, according to another embodiment of the present invention.

[0023] FIG. 7 exemplarily illustrates a front view of the knee support assembly with thread-motor assembly, according to yet another embodiment of the present invention.

[0024] FIG. 8 exemplarily illustrates a rear view of the knee support assembly with thread-motor assembly, according to yet another embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
[0025] A description of embodiments of the present invention will now be given with reference to the Figures. It is expected that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

[0026] Referring to FIGs. 1 and 2, a front view and a rear view of a therapeutic knee brace system or a wearable multifunctional knee brace system (hereinafter referred as system), according to an embodiment of the present invention. In one embodiment, the system is provided with integrated continuous passive mobilization. The system comprises a knee support assembly 100. The knee support assembly 100 is designed to be readily apparent to worn on the leg of the user for stabilizing the knee. In one embodiment, the knee support assembly 100 is adapted to wear on both legs of a user for stabilizing the knee. The knee support assembly 100 comprises a brace assembly. In one embodiment, the brace assembly comprises a pair of upper brace member 102 and a pair of lower brace member 104. In one embodiment, each brace member comprises two braces. In one embodiment, the knee support assembly 100 further comprises an additional band 105. The additional band 105 is attached to the knee support assembly 100 at the proximal end, which supports a servomotor and wraps around the hip of the patient. In one embodiment, the additional band 105 is configured to keep the knee support assembly 100 stays in position while performing continuous passive mobilization (CPM).

[0027] In one embodiment, the knee support assembly 100 further comprises one or more straps or wrapping means 106 configured to secure the brace members (102 and 104) to the user’s leg 150 as shown in FIG. 4. In one embodiment, the upper brace members 102 are secured to the upper leg or thigh, whereas the lower brace members 104 are secured to the lower leg and worn while walking using straps 106. In one embodiment, the straps 106 could be releasable cord. In one embodiment, the straps 106 could be adjustable cord. In one embodiment, the straps 106 has one or more fastener at its end. In one embodiment, the fastener could be, but not limited to, hook and loop (Velcro) fasteners, button, snap, or other similar fasteners to close and tighten the strap 106.

[0028] In one embodiment, the knee support assembly 100 further comprises one or more leg support rods including upper leg support 108 and lower leg support 110. The leg supports (108 and 110) are lightweight rods on either side of the brace members (102 and 104). In one embodiment, the leg supports (108 and 110) on either side of the brace members (102 and 104) are configured to provide mechanical stability to the knee joint as shown in FIG. 4. In addition, the upper brace member 102 and the lower brace members 104 are connected via an intermediate leg support rod 111. In one embodiment, the knee support assembly 100 further comprises a digital goniometer 112 and a motor assembly 114.

[0029] Referring to FIG. 3, an inner aspect of the knee support assembly 100 configured to deliver the continuous passive mobilization, according to one embodiment of the present invention. The knee support assembly 100 comprises a brace assembly including a pair of upper brace member 102 and a pair of lower brace member 104. In one embodiment, the knee support assembly 100 further comprises one or more straps or wrapping means 106 configured to secure the brace members (102 and 104) to the user’s leg 150. In one embodiment, the straps 106 could be releasable fasteners include, but not limited to, hook and loop (Velcro) fasteners. The knee support assembly 100 further comprises one or more leg support rods having upper leg support 108 and lower leg support 110. The leg supports (108 and 110) are lightweight rods on either side of the brace members (102 and 104), respectively.

[0030] In one embodiment, the knee support assembly 100 further comprises a digital goniometer 112. The digital goniometer 112 is incorporated at one end of at least one leg support (108 or 110). In one embodiment, the digital goniometer 112 is incorporated at one end of the lower leg support 110. The goniometer is configured to estimate the degree of movement at the knee joint. The knee support assembly 100 further comprises a motor assembly 114. In one embodiment, the motor assembly 114 is incorporated at one end of at least one leg support (108 or 110). In one embodiment, the motor assembly 114 is incorporated at one end of the upper leg support 108. The motor assembly 114 is configured to control the knee support assembly 100 and deliver continuous passive mobilization to the knee joint. In one embodiment, the motor assembly 114 is a servo motor assembly. In one embodiment, the knee support assembly 100 further comprises an additional band 105. The additional band 105 is attached to the knee support assembly 100 at the proximal end, which supports a servomotor and wraps around the hip of the patient. In one embodiment, the additional band 105 could have a detachable and adjustable fastener. In one embodiment, the fastener could be, but not limited to, hook and loop (Velcro) fasteners, button, snap, or other similar fasteners to close and tighten the additional band 105.

[0031] In one embodiment, the knee support assembly 100 further comprises an array of sensors incorporated into the brace assembly. In one embodiment, the array of sensors includes one or more electromyography (EMG) sensors 116 and one or more inertial sensors. The EMG sensors 116 are utilized separately for quadriceps, hamstrings, and gastro-soleus. In one embodiment, the EMG sensors 116 are EMG electrodes incorporated into the upper brace member 102. In one embodiment, the inertial sensors include, but not limited to, one or more ultrasound proximity sensors 118 and one or more accelerometer sensors. In one embodiment, the ultrasound proximity sensor 118 is incorporated into the lower brace member 104. In one embodiment, the sensors 116 are configured to aid in monitoring active as well as passive exercises performed by the user. In one embodiment, the knee support assembly 100 further comprises a hinge joint 120 incorporated into one of the leg supports (108 or 110). In one embodiment, the hinge joint 120 is incorporated into the upper leg support 108. The hinge joint 120 is configured to rotate around 360 degrees.

[0032] Referring to FIGs. 4 and 5, a right-side view and a left side view of the knee support assembly 100 worn on the user’s leg 150, according to one embodiment of the present invention. In one embodiment, the knee support assembly 100 is adapted to wear on both legs of a user for stabilizing the knee. The knee support assembly 100 comprises a pair of upper brace member 102 and a pair of lower brace member 104. In one embodiment, the upper brace members 102 are secured to the upper leg or thigh, whereas the lower brace members 104 are secured to the lower leg and worn while walking using straps 106. The knee support assembly 100 further comprises an upper leg support 108 and a lower leg support 110 on either side of the brace members (102, 104), respectively.

[0033] In one embodiment, the knee support assembly 100 further comprises the digital goniometer 112, motor assembly 114, and array of sensors. In one embodiment, the array of sensors and digital goniometer 112 keep track of muscle activity and range of motion at the knee joint. This could enable the knee support assembly 100 to be used as a monitoring system for active exercises advised by the health care provider. In one embodiment, the motor assembly 114 could precisely carry out continuous passive mobilization of the knee joint. In one embodiment, the motor assembly 114 is a servo motor. In another embodiment, the motor assembly 114 could be a thread motor. In one embodiment, the knee support assembly 100 further comprises a hinge joint 120 configured to rotate around 360 degrees.

[0034] Referring to FIG. 6, a perspective view of the knee support assembly 100 worn on the user’s leg 150, according to another embodiment of the present invention. The knee support assembly 100 comprises the brace assembly having the upper brace members 102 and lower brace members 104 secured to the upper leg or thigh and lower leg respectively, using straps 106. The knee support assembly 100 further comprises the leg support rods having the upper leg support 108 and lower leg support 110 on either side of the braces to provide mechanical stability to the knee joint.

[0035] The knee support assembly 100 further comprises an attachable track assembly 122 configured to support the user’s leg 150. In one embodiment, the track assembly 122 is configured to facilitate continuous passive motion (CPM) when the user lies down. In one embodiment, the track system 122 is a telescopic rail. In one embodiment, the track system 122 comprises a slot provided at the distal end to seat the user’s foot. In one embodiment, the track system 122 further comprises wheels and rail mechanism configured to provide smooth sliding movement of the limb on the rail during the passive mobilization of the knee. The track system 122 could be carried in a backpack during not in use and the same could be attached to the knee support assembly 100 during use.

[0036] Referring to FIGs. 7 and 8, a front view and a rear view of the knee support assembly 100 worn on the user’s leg 150 respectively, according to yet another embodiment of the present invention. The knee support assembly 100 comprises the brace assembly having the pair of upper brace member 102 and lower brace member 104. In one embodiment, the upper brace members 102 are secured to the upper leg or thigh, whereas the lower brace members 104 are secured to the lower leg and worn while walking using straps 106. The knee support assembly 100 further comprises the leg support rods having the upper leg support 108 and lower leg support 110. In one embodiment, the leg supports (108 and 110) on either side of the brace members (102 and 104) are configured to provide mechanical stability to the knee joint.

[0037] In one embodiment, the knee support assembly 100 further comprises an alternate power delivery system or motor assembly 114. In one embodiment, the motor assembly 114 is configured to control the knee support assembly 100 and deliver continuous passive mobilization to the knee joint. In one embodiment, the motor assembly 114 is a thread motor. In one embodiment, the knee support assembly 100 further comprises one or more fiber threads or strings having high tensile strength. In one embodiment, the knee support assembly 100 comprises at least two pairs of strings includes a first pair of strings 124 and a second pair of strings 126. The strings are disposed at the knee support assembly 100 such that the strings lie on the front and rear side of the limb. The first pair of strings 124 could be in the front of the limb, whereas the second pair of strings 126 could be in the rear of the limb. In one embodiment, the strings (124 and 126) are carbon fiber threads. In one embodiment, the strings are lengthened and shortened using the motor assembly 114. The lengthening or shortening of the strings (124 and 126) aid in passive lesion and extension of the knee, thereby providing continuous passive mobilization. The motor assembly 114 could be pre-programmed to suit the group of muscles that have to contracted/activated by the user.

[0038] In one embodiment, the knee support assembly 100 further comprises a biofeedback interface. In one embodiment, the inputs or data from the sensors (116 and 118), digital goniometer 112, and motor mechanism 114 are integrated, analyzed, and fed into the biofeedback interface and/or an optical gear. The biofeedback interface could be, but not limited to, a smartphone, mobile phone, laptop, tablet, or other handheld electronic communication device installed with a dedicated application. The application could be a mobile software application or web-based software application. The application functions as an end-to-end communication and monitoring system between the user/patient and health care provider. In one embodiment, analyzed data could be fed into the optical gear for augmented reality (AR) or virtual reality (VR).

[0039] In one embodiment, the AR/VR gear could also be used as a real-time biofeedback platform to encourage users to perform the mobilization exercises as per the protocols advised by the health care team. In one embodiment, the data gathered from the sensors could be processed and delivered on the mobile application or AR/VR gear. The processed data serve as continuous real-time biofeedback to the user. Also, it serves as a mode of end-to-end feedback/communication between the user and the health care provider. Using the real-time feedback through the mobile application or AR/VR gear, muscle strengthening exercises could be executed by encouraging the user to exert antagonistic force against the motor assembly 114. Further, the direction of action of the motor assembly 114 could be preprogrammed to suit the group of muscles that have to be contracted or activated by the user.

[0040] Advantageously, the knee support assembly is an integrated wearable system that provides assistance and monitoring of active exercises, continuous passive mobilization, and assistance in muscle strengthening exercises. The real-time biofeedback using mobile application or AR/VR gear could increase the patient compliance and effectiveness of the rehabilitation protocols. Being a wearable system, CPM protocols could be continued at a user’s house or workplace, unlike the conventional system where the user pays frequent visits or gets admitted to the rehabilitation center. The knee support assembly assists the user to perform active muscle strengthening exercises that could otherwise need assistance by a physiotherapist or sophisticated equipment separately for separate groups of muscles.

[0041] In addition, the knee support assembly could be linked to the smartphone-based application that acts as an interface between the user/patient and the health care provider. This helps in better patient monitoring, early intervention, and wider data acquisition. This could also reduce the need for frequent visits to the rehabilitation center, which apparently would reduce transportation costs. It facilitates the user to perform all knee-related rehabilitation protocols home-based, with better monitoring and tracking, which could help the user to recover sooner and reduce the rehabilitation period. By making the health care provider and various rehabilitation equipment virtually available at home, this wearable device could be highly beneficial for rural communities with limited access to physiotherapy services. Further, the knee support assembly could also be extended to other anatomical areas such as elbow and ankle.

[0042] Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. It should be understood that the illustrated embodiments are exemplary only and should not be taken as limiting the scope of the invention.

[0043] The foregoing description comprise illustrative embodiments of the present invention. Having thus described exemplary embodiments of the present invention, it should be noted by those skilled in the art that the within disclosures are exemplary only, and that various other alternatives, adaptations, and modifications may be made within the scope of the present invention. Merely listing or numbering the steps of a method in a certain order does not constitute any limitation on the order of the steps of that method. Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings in the foregoing descriptions. Although specific terms may be employed herein, they are used only in generic and descriptive sense and not for purposes of limitation. Accordingly, the present invention is not limited to the specific embodiments illustrated herein.