Technical Field

The invention relates, in general, a device that provides biofeedback that will be used to perform blood flow restricted exercises.

The invention particularly relates to a device system with biofeedback for blood flow restricted exercises that can be used by both healthy persons and persons in the rehabilitation phase after injury, either on their own or under the supervision of a healthcare professional.

State of the Art

Blood flow restricted exercises are exercises performed with lower weights (20-30% of 1 RM) rather than classical resistance exercise programs performed at 70-85% of the maximum weight lifted (one repetition maximum: 1 RM). It is known that when athletes apply this form of exercise for 6-8 weeks, they can achieve results similar to the effects of resistance exercises performed with high weights in terms of muscle hypertrophy (growth). In the conducted scientific studies, it is reported that exercise with restricted blood flow increases muscular force, provides hypertrophy (growth) in muscle cells, and improves regional and cardiovascular (cardiovascular) endurance.

It is thought that these positive effects that increase physical fitness are caused by mechanisms different from the adaptation mechanisms created by classical resistance exercises. It is assumed that effects of blood flow restricted exercises are conversion or development of muscle fibres into fast-twitch fibres due to hypoxia (lack of oxygen), stimulation of metaboreceptors and the development of an extremely acute (rapidly progressive) systemic hormone response due to longer-term metabolic acidosis (excessive amounts of acid or alkaline (base) in the blood) and intramuscular (intramuscular) proton (H+ ion) deposition, the increase in growth factors and intracellular signals as a result of the differences in the contractile mechanism caused by externally applied pressure and the deformation of the sarcolemma (muscular fibre membrane), metabolic adaptation to the rapid glycolytic (breakdown of glucose) system caused by damaged oxygen distribution, production of reactive oxygen products, and formation with the reactive hyperaemia (excessive blood supply in the tissue) and activation of myogenic (muscle-derived) stem cells caused by the removal of externally applied pressure.

Although the mechanism of action has not yet been fully clarified, it is recommended to use blood flow restricted exercise to increase sportive performance, as well as in the early rehabilitation process, especially after surgery, where high-weight resistance exercises cannot be applied. Restricted blood flow exercises can also be used in patients with a diagnosis of patellofemoral pain syndrome (originating from the joint itself or adjacent soft tissues), spinal cord injury etc.where muscle mass should be increased as a necessity of treatment, but treatment compliance problems are experienced due to the inability to withstand the pain experienced during high-weight exercise. Considering that long-term and repetitive high-weight resistance exercises cause overuse injuries in athletes, it can be predicted that the use of this form of exercise will protect healthy athletes from overuse type sports injuries. For this reason, blood flow restricted exercises are frequently applied by healthy athletes, as well as by athletes who have undergone surgical operation and are in the rehabilitation phase, especially after musculoskeletal injury.

Biofeedback is a common clinical method used to provide real-time information about the physiological state that would not typically be perceived by the user. With biofeedback, individuals are provided with information on how to best perform motor skills. With biofeedback exercises, the attention of the athlete is directed step by step to the components of a skill. Based on the idea that cognitive control is necessary before the skill becomes more or less automatic, the use of these feedback techniques to provide this cognitive control helps the exercise training adaptations to yield better results. Biofeedback exercises are exercises that contribute to reshaping and adaptation of the muscle. It was shown in our previous studies that in addition to the increase in muscle strength and endurance of both healthy individuals and patients in need of rehabilitation, biofeedback exercises combined with strength exercise also contributes to other physical parameters such as joint control, deep sense of sensation, balance and coordination, etc. Current models used for restricted blood flow exercises include features such as realtime monitoring of pressure changes in the cuff attached to the extremities (limb) on a digital screen, the use of a pulse sensor to determine the pulse pressures in the extremities inside the cuff (by determining the pressure value that cuts the pulse in the extremities, the target exercise pressure determined for the person who will do the exercise (for example, 40% or 80% of the pressure that cuts the heart rate) can be automatically calculated and the cuff pressure can be adjusted), keeping the target exercise pressure determined for the person constant during the exercise (for example, it is ensured that the setting made at 100 mm Hg does not change during the exercise), thus ensuring that this pressure does not fall below the determined pressure during the entire exercise, keeping information regarding the exercise to be performed, such as right/left, arm/leg, pulse-stopping pressure, target exercise pressure, maximum pressure, etc., as well as personal identifying information in the personal file of the individuals who will exercise, and storing the data such as 0 ^th day exercise/1 ^st month exercise etc. recorded in the individual’s file in a way that allows comparison.

However, many existing models used for blood flow restricted exercises do not have the features of biofeedback and the ability for a health professional to create and follow an exercise program for the exerciser by logging into his own profile, and to analyse the exercise performance by graphing it.

One of the documents in the state of the art, the application with the publication number US2018021210 A1 , can be selected as the document closest to the invention in the state of the art. The application mentions an efficiency-based feedback system for blood flow restriction exercise. The invention includes, for use in a BFR (blood flow restriction) system, an outer strap material hermetically sealed to an inner strap material along an inflatable perimeter, at least one inflatable chamber obtained in this way, an inlet port for the inflatable chamber to receive gas, a first attachment means in communication with the outer belt material for engaging a second fastening means in communication with the outer belt material. Thus, when the inflatable strap is wrapped around a limb, it can be used during the user's performance of a BFR exercise session and/or program based on evaluation of efficiency feedback data. An efficiency feedback tool is used to collect efficiency feedback data for use in prescribing, monitoring, and adjusting one or more exercise parameters. However, in said application, there is no mention of software, a battery and an external power input that allows a healthcare professional to enter his own profile and prepare an exercise program for the user.

In order to determine the state of the art, the documents with publication numbers US2011060231 A1 , US2015297909 A1 and WO2016011538 A1 can also be examined, however, neither the documents mentioned above nor the other disclosures in the state of the art mention a device system with biofeedback for blood flow restricted exercises that can be used by both healthy people and people in the rehabilitation phase after injury, either on their own or under the supervision of a healthcare professional.

Conclusively, due to the above described problems and the insufficiency of the existing solutions made it necessary to make an improvement in the relevant technical field.

The Aim of the Invention

The invention was created by being inspired by the current situations and aims to solve the abovementioned negativities.

The main aim of the invention is to deliver a device that provides biofeedback that will be used to perform blood flow restricted exercises. With this invention, the efficiency of exercise and user satisfaction will be increased by providing biofeedback during blood flow restricted exercise. With these features, this invention closely concerns the healthcare professionals, biomedical engineering and the medical equipment manufacturing sector.

Another aim of the invention is to present a biofeedback device system for blood flow restricted exercises that both healthy people and people in the rehabilitation phase after injury can use on their own or under the supervision of a healthcare professional.

Another object of the invention is to provide a biofeedback device system with a software, in which a healthcare professional other than the exerciser can create his/her own profile and enter this profile as a supervisor and allow the exerciser to prepare the exercise program and follow the exercise, a battery and an external power input. With the invention, programs suitable for targeted muscle contractions (muscle tension) can be created as a result of biofeedback. The individual can follow the contractions and see the percentage of successfully achieved the targeted contractions while doing the exercise in the desired range of motion.

Another aim of the invention is to present a biofeedback device system that enables graphing the exercise performance and analysing it.

Another aim of the invention is to present a biofeedback device system that enables transferring the exercise data to an external environment. With the invention, the analysis of the changes in the pressure graph can be presented as a data dump (target pressure, maximum pressure, total exercise time, time to stay at target pressure, time to stay at maximum pressure, etc.) in excel file format to smart phones or computers with a wireless network connection - preferably with Wi-Fi or Bluetooth - during and after exercise. By this way, new data will be obtained for scientific studies to be carried out in the field of blood flow restricted exercise.

Another aim of the invention is to present a biofeedback device system that provides the athlete with a more comfortable range of motion and offers the opportunity to exercise in wider joint ranges of motion with biofeedback. Exercises with biofeedback involve different types of muscle contractions. The stimulation of the muscle spindle (sensory organ extending parallel to the fibres in the muscle) receptors increases during exercise due to the occurrence of both concentric (shortening of the muscle while its tonus (tension) remains the same) and eccentric (stretching of the muscle length) contractions. It can be said that this effect will contribute to the development of proprioception (joint position sense).

Another aim of the invention is to present a biofeedback device system that can be used as a tourniquet to control blood flow in surgeries.

Another aim of the invention is to present a biofeedback device system that can be used as a blood pressure monitor via its pulse sensor.

In order to fulfil the above-described purposes, the invention is a biofeedback device system for blood flow restricted exercises that individuals can use on their own or under the supervision of a healthcare professional, comprising

• at least one cuff that provides attachment to the limbs of the person who will use the device system, at least one pressure sensor enabling the pressure applied to the limb within said cuff to be measured,

• at least one valve that will be activated in case the pressure value read from the said pressure sensor is greater than the target pressure value previously entered in the device system, ensuring the pressure applied to the limb is reduced to the target pressure value,

• at least one compressor that will be activated in case the pressure value read from the said pressure sensor is less than the target pressure value entered in the device system beforehand, ensures that the pressure applied to the limb is increased to the target pressure value,

• at least one processor that ensures the operation and data control of said pressure sensor, valve and compressor,

• software that works on the said processor, providing the management of the device system by interpreting and comparing the data coming to the processor, creating profiles for the user and the healthcare professional on the device system and creating an exercise program for the user through the healthcare professional profile, and enabling the data coming to the processor to be recorded on the profile of the relevant user and/or healthcare professional together with the date information,

• at least one screen that provides instant and graphical presentation of the data interpreted by the said software to the user, shows how often the movement is repeated, and allows command and/or data entry to the device system,

• at least one battery that stores the energy the device system needs to operate

The structural and characteristic properties and all advantages of the invention will be more clearly understood with the figures given below and the detailed description written with reference to these figures and therefore, the assessment should also be made by taking these figures and the detailed description into account. Figures to Help Understand the Invention

Figure 1 is the representative block diagram view of the biofeedback device system for blood flow restricted exercise that is the subject of the invention.

Figure 2 is the representative perspective view of the biofeedback device system for blood flow restricted exercise that is the subject of the invention.

Figure 3 is a representative perspective view of the external power input of the biofeedback device system for blood flow restricted exercise that is the subject of the invention.

Figure 4 is the flow diagram of the biofeedback device system for blood flow restricted exercise that is the subject of the invention.

Figure 5 is the representative view of the screen of the biofeedback device system for blood flow restricted exercise that is the subject of the invention.

Description of Part References

1. Cuff

2. Pressure Sensor

3. Valve

4. Compressor

5. Processor

6. Software

7. Screen

8. Battery

9. Air canal 10. Communication Module

11. Alarm Unit

12. Smart Device

13. Interface

14. Circuit

15. Charger plug

16. External Power Input

17. Pulse Sensor

1001. Start

1002. Receive the target pressure value

1003. Is battery level below 15%?

1004. Switch the device system to standby mode.

1005. Read the instant value of the pressure sensor.

1006. Are the instant pressure value and target pressure value the same?

1007. Stop the compressor, close the valve.

1008. Record the instant pressure value, stopping information of the compressor and valve, and battery level.

1009. Is the instant pressure value lower than the target pressure value?

1010. Open the valve.

1011. Activate the compressor.

1012. Record the instant pressure value, operation information of the valve and compressor, and battery level.

Y. Yes N. No

Detailed Description of the Invention

In this detailed description, the biofeedback device system and its preferred embodiments for blood flow restricted exercises, which are the subject of the invention, are explained only for better understanding of the invention, without any restrictive effect.

Figure 1 is a representative block diagram view of the biofeedback device system for blood flow restricted exercises that individuals can use on their own or under the supervision of a healthcare professional.

The biofeedback device system for the blood flow restricted exercises that is the subject of the invention includes a cuff (1), which allows holding onto the limbs of the person who will use the device system.

In a preferred embodiment of the invention, there is a pulse sensor (17) inside the said cuff (1), which allows to measure the pulse and/or detects the pressure that cuts the pulse of the limb to which the cuff (1) is attached when the pulse cannot be measured. By means of the said pulse sensor (17), the invention can be used as a manoscope.

The biofeedback device system for blood flow restricted exercises includes a pressure sensor (2) that enables the pressure applied to the limb inside the said cuff (1) to be measured.

In a preferred embodiment of the invention, said pressure sensor (2) can measure the pressure value up to 3000 mm Hg (millimeters of mercury).

Within the device system, there is a sophisticated pressure sensor (2) that can measure the pressure level that will occur.. Unlike sensors that measure up to 300 mm Hg in medical applications on the market, the pressure sensor (2) for the designed device system can precisely measure pressure up to 3000 mm Hg. By this way, the measurement capacity of our device system is high compared to all medical application devices. The value determined for the desired target pressure during the exercise is kept in balance by being constantly checked by the device system. During the movement, the pressure levels on the cuff (1 ) connected to the device system can change instantaneously depending on the intensity and density of the movement. The healthcare professional who will perform the application during the exercise can precisely track how much pressure the muscle and tissue are exposed to at the application point.

The biofeedback device system for exercises with restricted blood flow also comprises a valve (3) that will be activated in case the pressure value read from the said pressure sensor (2) is greater than the target pressure value previously entered in the device system, ensuring the pressure applied to the limb is reduced to the target pressure value, and a one compressor (4) that will be activated in case the pressure value read from the said pressure sensor (2) is less than the target pressure value entered in the device system beforehand, ensuring that the pressure applied to the limb is increased to the target pressure value.

The valve (3) and the compressor (4) in the device system work reciprocally to provide the desired pressure level and keep it in balance.

In a preferred embodiment of the invention, there is an air canal (9) that provides air exchange between the said cuff (1) and the pressure sensor (2), valve (3) and compressor (4).

The biofeedback device system for exercises with restricted blood flow comprises a processor (5) that ensures the operation and data control of said pressure sensor (2), valve (3) and compressor (4), and software (6) that works on the said processor (2), providing the management of the device system by interpreting and comparing the data coming to the processor (5), creating profiles for the user and the healthcare professional on the device system and creating an exercise program for the user through the healthcare professional profile, and enabling the data coming to the processor (5) to be recorded on the profile of the relevant user and/or healthcare professional together with the date information.

The data can be monitored and recorded in real time by means of the software (6). The saved data can be accessed later. The memory of the processor (5) is used for recording. Afterwards, this data can be transferred to another computer, smart phone or tablet if desired. The software (6) records all data in such a way that it can be used in retrospective scans in all medical or clinical applications.

The processor (5) takes the target pressure value obtained from the software (6) and in order to keep this value constant and balanced, it operates either the valve (3) or the compressor (4), whichever is needed, so as to prevent the muscle and tissue from remaining above or below the desired target pressure value during exercise. If the pressure is above the desired level, the valve (3) operates, and if it is below the desired level, the compressor (4) operates.

In a preferred embodiment of the invention, said processor (5) is a micro controller with open, re-codable, flexible software (6). Said micro controller is an advanced, programmable, upgradeable micro controller. The software (6) is executed with a flexible algorithm. By this way, the operation of the device system is not standard, but all desired updates can optionally be made within the boundaries of peripheral hardware. Thus, the user and/or healthcare professional can operate the device system as they desire.

In the biofeedback device system for exercises with restricted blood flow, there also is screen (7) that provides instant and graphical presentation of the data interpreted by the said software (6) to the user, shows how often the movement is repeated, and allows command and/or data entry to the device system.

Through the screen (7), data entry can be made to the device system and exercise performance can be monitored.

In a preferred embodiment of the invention, said screen (7) is LCD or LED.

The device system can analyse the movement of the limb to which it is attached. By the help of the screen (7) it can visually inform the user, during and at the end of the exercise, about the energy consumed during that exercise from pressure changes and accelerational movements at the point where it is attached, the duration of the exercise, and how accurate or efficient the movement is.

Figure 5 is the representative view of said screen (7). Through the screen (7), all patient records and retrospective patient inquiries, communication settings and pressure values can be set. In addition, target exercise chart, instant data observation, exercise times, battery status, pressure change graph during exercise, intensity of movement during exercise, state of approaching target pressure visually, average exercise success and frequency of repetition of movement can be observed.

Finally, the basic configuration of the biofeedback device system for blood flow restricted exercises includes the battery (8), which allows the device system to store the energy it needs to work.

The use of said battery (8) makes the device system independent from the environment and movement limitation. There is a light, fast-charging and long-life battery (8) in the device system. In medical applications, it can be fully charged in as little as 30 minutes in the case the battery is empty, or it can be easily replaced with another battery (8) if desired. From the moment the application starts, a battery (8) can operate the device system for about 5-6 hours in active use, depending on the intensity of movement, and preferably informs the user by sending its charge status to the software (6). For example, when the battery (8) level is 15%, a warning is sent to the screen (7) via the software (6), and then if the level falls below the critical level (for example, 5%), the software (6) shuts down the device system, again the software (6) sends a warning the screen (7) and device is put to standby mode. A power circuit/battery management system is also designed within the device system, preferably in order for the battery (8) to have a long life and to have a healthy charge.

In a preferred embodiment of the invention, there is a communication module (10) that enables the device system to communicate with an external device. In this embodiment, there is a smart device (12) that receives the exercise data from said communication module (10) and an interface (13) that operates on said smart device (12) and enables the data to be displayed to a remote observer. The device system can enable multiple people to be tracked at the same time by means of the communication module (10) that sends data in Excel format using Wi-Fi (wireless area) and/or Bluetooth communication protocols, and its Wi-Fi feature.

There is a communication module (wireless network module) (10) in the device system that can be easily connected to all computers, smart phones or tablets. By this way, the device system can be controlled by all hardware, such as a computer, smart phone or tablet, to which it can be connected with the communication module (10), notwithstanding a single brand and model. This feature provides flexibility in the work area. In the event that the user and the healthcare professional are not(cannot be) in the same environment, the device system can transmit the data it produced during the exercise in real time by means of the communication module (10).

In order for the device system to be easily transported, it must be wireless in both electrical and data transmission. For this reason, there is a wireless communication module (10) in the device system. However, if desired, it is possible to create its own wireless network structure and to monitor multiple device systems over a single smart device (12) in multiple exercise applications., examples of which are not encountered in market applications today.

Said smart device (12) may be a phone, tablet or computer.

In a preferred embodiment of the invention, there is an alarm unit (11 ) that provides a written, audible and/or visual warning when the biofeedbacks received from the user do not comply with the exercise program created in the device system. Warning can be provided by LED lights and/or speaker and/or text passing through the screen (7).

In a preferred embodiment of the invention, there is a circuit (14) ensuring the distribution of the power received from said battery (8) to the pressure sensor (2), valve (3), processor (5) and the screen (7) in line with the supply voltage and/or data entry voltage of each and enabling command and/or data entry to the device system. Via the buttons placed on the circuit (14), it can have functions such as switching between on/off and start/stop or entering numbers.

In a preferred embodiment of the invention, there is a charger plug (15) that enables the said battery (8) to be charged.

In a preferred embodiment of the invention, there is an external power input (16) that provides the energy needed for the device system to operate by connecting an external energy source to the device system.

Thus, when the battery (8) depletes and cannot be charged, it can be powered from the outside, for example by a power bank. The device system can be operated with all adapters/energy sources with an output of at least 5 Volts and above suitable for the external power input (16) available in the market.

In a preferred embodiment of the invention, it can be used as a tourniquet that provides control of blood flow in surgeries. In cases such as surgery etc., restricted blood flow may be required. The device system restricts blood flow throughout the body in a way that does not damage tissues. Tourniquets completely stop the blood flow at the points they are attached to. This situation is not good for tissues and surrounding organs. Therefore, it should be loosened at certain intervals, let the blood flow, and then tightened again, or if it is pumped, its pressure should be increased. However, the device system we designed also allows the user to control the blood flow at the point where it is located, at intervals and values determined by the user.

A preferred embodiment of the invention works as follows;

The software (6) takes the target pressure value to be applied to the limb to which it is attached from the input. It then checks the charge level of the battery (8). If the charge is not sufficient, the device puts the system on standby.

If the charge is sufficient, it reads the pressure value from the pressure sensor (2) and compares it with the target pressure value. If the instant pressure value and the target pressure value are the same, the valve (3) or the compressor (4) are both closed if they are open, or kept closed if they are closed. The same checking cycle continues as long as the target pressure value is not changed or the instant pressure value does not change.

If the instant pressure value and the target pressure value are different, then the system checks which one is greater. If the instant pressure value is greater than the target pressure value, the valve (3) is operated, and if it is smaller, the compressor (4) is operated. Afterwards, the instant pressure value, running valve (3) or compressor (4) information and battery (8) level are recorded. The loop continues from the charge state sufficiency check. The algorithm in question is shown in Figure-4.

The device system that is the subject of the invention has been designed in such a way that it can be used in a user-oriented manner. The intended use of the device system can be used both medically under the supervision of a specialist healthcare professional in clinical settings, and, if desired, the individual purchasers can use it themselves without the need for a program or personnel that require any expertise. In clinical applications, the healthcare professional can create an exercise program for therapeutic exercise under the pressure value desired and the time specified in the clinic. In this context, a software (6) has been developed in which an exercise program can be created for the use and monitoring of the device system. This software (6) initially creates a file record with the names of the person to be treated and the health professionals who will perform the application and with date and time information. Then, the healthcare professional who will perform the application designs an exercise schedule that s/he deems appropriate for the device system to operate and the exercise to be performed during the application, which is an important feature that distinguishes it from similar devices available in the market.

This designed schedule can be prepared flexibly and custom-made. Then, the healthcare professional who will perform the application enters the target pressure value determined for the person to exercise into the device system. After all these settings are finished, the software (6) gives the relevant command to operate the device system and the exercise starts. The software (6) starts to graph whether the data coming from the device system is at the desired level, the battery (8) level of the device system, the target pressure value and the instant pressure value. All data written into the graph is also saved in the file created at the beginning.

During the application, the person doing the exercise can monitor on the screen (7) how well and successful movements s/he does and can correct any missing or incorrect movements. When the exercise is finished, the past exercise applications and the new applications can be compared by means of the software and the progress of the exerciser is presented in a way that can be interpreted through numerical data. If the individuals doing the exercise wish, they can take their own data and easily graph it on their own computer and follow themselves. If the individual doing the exercise and the health professional doing the exercise are not in the same environment, the device system can send data over the internet.

Biofeedback exercises that can be tailor-made programmed can be included in the software (6) developed as standard suggested exercises with predefined loads according to the person's sports discipline, diseases, age, gender, etc. Thus, alternative biofeedback exercises can be availably presented to the user within the device system. Furthermore, in the invention, users can save personalized biofeedback exercises in the memory of the device system and the same exercises and performance results can be accessed in the next application or user.

In individual applications, feedback is given to the user via the screen (7) located on the device system itself. Instant pressure value and visual feedback are also provided.

The device system can be used individually or in exercise centres by means of its clinical and individual application options.

By the help of the invention, it is enabled to create exercise programs suitable for individual and targeted muscle contractions with biofeedback, to follow the contractions while performing the exercise in the desired range of motion, to see the success rate of the targeted contractions, to dump data of the changes in the pressure graph during and after the exercise to smart phones or in excel format via WiFi connection (target pressure, maximum pressure, total exercise time, time to stay at target pressure, time to stay at maximum pressure, etc.), to present data on both graphics and numerical values of pressure in the data dump, to compare the data of two different people over the recorded data, and to give visual and audible warnings of pressure changes during exercise such as bar graph/green-yellow-red colour transition while exercising in a way to provide biofeedback to the patient/athlete.

Thus, a biofeedback device system is introduced for blood flow restricted exercises that both healthy people and people in the rehabilitation phase after injury can use on their own or under the supervision of a healthcare professional.

References

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