WO2007074451A2 - Procede et systeme d'entrainement cardiovasculaire - Google Patents

Procede et systeme d'entrainement cardiovasculaire Download PDF

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Publication number
WO2007074451A2
WO2007074451A2 PCT/IL2006/001489 IL2006001489W WO2007074451A2 WO 2007074451 A2 WO2007074451 A2 WO 2007074451A2 IL 2006001489 W IL2006001489 W IL 2006001489W WO 2007074451 A2 WO2007074451 A2 WO 2007074451A2
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equal
vdm
counter
compressor
operational stage
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WO2007074451A3 (fr
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Jakob Barak
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Medical Compression System (dbn) Ltd
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Medical Compression System (dbn) Ltd
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5056—Control means thereof pneumatically controlled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/04—Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/04—Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
    • A61H2230/06—Heartbeat rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/30—Blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/40—Respiratory characteristics
    • A61H2230/42—Rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/65—Impedance, e.g. skin conductivity; capacitance, e.g. galvanic skin response [GSR]

Definitions

  • the term “ergoreflex” is used to refer to a strong, static (isometric) contraction of skeletal muscles or a rapid, powerful rhythmic dynamic (heterometric) contraction that causes a pronounced increase in arterial blood pressure, heart rate and respiratory rate 1 .
  • signals are received by the cardiovascular centers from the motor areas of the brain where the voluntary contraction is initiated and from muscle receptors that sense the degree of activity of the contracting muscles.
  • CHF chronic heart failure
  • L-aginine a nitric-oxide precursor
  • the impairment in endothelial-dependent vasodilatation is correlated with the degree of exercise intolerance and of the so-called New- York Heart Association class. Improvement in endothelial dysfunction is associated with improved exercise tolerance and the individual's sensation of well-being.
  • regular aerobic exercise of the legs improved both basal and stimulated endothelial nitric-oxide (NO) formation and agonist mediated endothelium-dependent vasodilatation of the skeletal muscle vasculature. Correction of endothelium dysfunction was associated with a significant increase in exercise capacity.
  • Previous studies have reported improved vascular endothelial function in the upper-limb after handgrip exercise training in CHF subjects.
  • Intermittent pneumatic compression (IPC) of the limbs has been found to mimic the effect of muscle training on the vascular beds. Muscle contraction and IPC sleeve inflation were both found to significantly increase the shearing forces over the endothelial cells.
  • IPC Intermittent pneumatic compression
  • Muscle contraction and IPC sleeve inflation were both found to significantly increase the shearing forces over the endothelial cells.
  • the sudden compression causes a forward pulsatile venous blood flow resulting in complete draining of blood at the compression site.
  • the distention caused by the rush of blood volume imposes a compressive strain on the venous endothelial cells, while the increased flow velocity imposes an increased shear stress on the same endothelial cells.
  • the rate of pressure development (dp/dt) produced by IPC devices was found to be an important factor in determining the modulation of distant microcirculation induced by the treatment, while peak-pressure duration did not.
  • IPC ischemic heart disease
  • EECP Enhanced External Counter-Pulsation devices
  • ECG electrocardiograph
  • EECP improves peripheral endothelial function in individuals with advanced coronary artery disease 1 . Moreover, it was shown that individuals who experience clinical improvement during EECP show an additional enhancement of their endothelial dependent vasodilation one month after completion of therapy IX ' x . The EECP treatment thus appears to provide hemodynamic stimuli similar to those of physical exercise that contribute to the improvement in endothelial function. EECP was shown to improve exercise tolerance in CHF, to increase coronary flow reserve and to reduce high arterial blood pressure. However, this treatment device is very expensive, the individual is confined to bed during the treatment and the treatment must be given in special clinics under close supervision.
  • the present invention provides a method and system for cardiovascular training in an individual.
  • the invention may be used, for example, for treating an over-active ergoreflex such as occurs in CHF, for increasing the coronary flow reserve in IHD and for reduction of blood pressure in hypertensive individuals.
  • the invention is particularly useful in cases of impaired exercise tolerance in which adequate muscle training may be problematic and even impossible.
  • intermittent compression is administered to one or more body limbs of the individual.
  • the state of vasodilatation of the individual is monitored as the compression is administered, and the parameters of the compression are modulated in accordance with the individual's state of vasodilatation.
  • the system of the invention includes one or more massaging sleeves for applying intermittent pressure to a body limb of the individual.
  • the massaging sleeves are typically divided into a plurality of individually inflated cells along its length, with each cell being connected to a control unit by a separate hose.
  • the cells are inflated by a pump or compressor that delivers a compressed fluid, preferably ambient air to each cell via each cell's dedicated hose.
  • the pump or compressor is actuated by a processor that is configured to execute a desired temporo-spatial regime of inflation and deflation of the cells.
  • the processor may be configured to operate the pump or compressor so as to generate peristaltic contractions of the sleeve.
  • the system of the invention further comprises a device for monitoring one or more parameters indicative of the individual's state of vasodilatation.
  • the device may be, for example, a finger plethysmograph, a peripheral pulse pressure signal, a pulse oximetry signal, or an impedance meter that monitors changes in blood vessel impedance. Signals generated by the device are input to the processor. This is in contrast to the EECP systems which include a device that monitors the heart cycle.
  • the processor is configured to actuate the pump or compressor according to a control algorithm in which the parameters of the inflation-deflation regime generated in the sleeve are determined based upon measurements received from the device.
  • the control algorithm allows, preferably in real time, optimization of the pressure profile applied to the body limb by the system in accordance with the individual's exercise level and clinical status.
  • the system of the invention may include a remotely located service center that communicates with the processor. Data ' received at the service center may be further processed and then communicated to a medical caregiver. Analysis of the data may be transmitted to the processor to be made available to the individual or a medical caregiver adjacent to the individual.
  • the service center may be manned by an operator who may study and analyze the data received from the device. The operator may also be capable of voice communication with the individual in order to advise the individual on using the apparatus, for example, the setting of the values of the various operating parameters of the inflation.
  • the processor may make a preliminary analysis of the input signals, thereby generating a set of analyzed data that is used by the processor to modify the parameters of the treatment.
  • the data maybe transmitted to the service center for further analysis either automatically or by an operator), and the results of this analysis transmitted back to the processor of the system, and used by the processor to modify the parameters of the treatment.
  • communication between the processor and the service center may be bi-directional.
  • Data may be stored in a memory associated with the processor and/or the service center in order to detect rends in the individual's response to the treatment, and to evaluate to what extent the treatment is succeeding.
  • the processor and/or the service center may provide a diagnosis of the individual's condition based upon the input signals.
  • an integer N operational stages are specified that are numbered from 1 to N.
  • Each operational stage is characterized by a specific pump rate, rate of pressure development ,maximal pressure developed on the limb, and the duration of the maximum pressure. The higher the operational stage number, the higher the pump rate and the developed pressure. Moving from a low operational stage to a higher one increases the efficacy of the massaging, and therefore a higher level of vasodilatation is expected.
  • An initial vasodilatation measurement VDM 0 is obtained by the device in the absence of applied pressure while the individual is at rest.
  • the operational state is progressively increased until a vasodilatation measurement is obtained by the device that is greater than VDM 0 .
  • the operational state is progressively increased until a vasodilatation measurement is obtained by the device that is within a predetermined range.
  • the system of the invention may optionally include sensors for determining changes in the individual's tolerance to exercise, and hence his level of rehabilitation.
  • sensors may include an ECG device for monitoring heart rate, a sphygmomanometer for monitoring blood pressure, and sensor for sensing respiratory rate. Measurements obtained by any one or more of such sensors can be communicated to the processor and stored in the memory, and possibly communicated to a remote service center.
  • Monitoring the maximal heart rate during treatment with the system of the invention provides information on both the individual's compliance with the exercise protocol, and for the individual's reconditioning and level of rehabilitation. Heart rate reduction at rest and during sub-maximal exercise is usually considered an improvement in the individual's exercise tolerance.
  • HRV heart rate variability
  • Monitoring blood pressure during treatment with system of the invention can also be used to monitor the individual's level of rehabilitation.
  • Peripheral resistance normally decreases during exercise. This occurs because of the tremendous increase in blood flow to working skeletal muscle. Vasoconstriction in non-exercising tissue is not enough to compensate for the vasodilatation in active muscles.
  • blood pressure does not fall during exercise, it increases.
  • Cardiac output increases greatly during exercise, which more than compensates, in normal individuals, for the fall in peripheral resistance.
  • Systolic blood pressure usually rises steadily during exercise with only mild effect on the diastolic blood pressure. This situation leads to a significant increase in pulse pressure and mean arterial pressure during exercise. Failure to increase systolic and mean arterial blood pressures during exercise suggests heart failure.
  • diastolic pressure remains unchanged or slightly decreases (less than 10 mmHg) during exercise.
  • a significant increase in diastolic pressure is associated with a greater prevalence of coronary artery disease, and CHF.
  • Endurance training reduces resting and sub-maximal exercise, systolic, diastolic, and mean arterial blood pressures. Diastolic and mean arterial blood pressures are reduced also at maximal exercise, while training usually has no effect on maximum systolic blood pressure. Long term follow up of pressure parameters can therefore provide a reliable indication of the individual's rehabilitation progress.
  • the combination of a high heart rate and systolic blood pressure suggests a high oxygen demand of the heart.
  • the rate-pressure product (the "Duble Product") is a useful predictor of myocardial load.
  • One of the goals of training is a gradual decrease in the individual's rest and exercise rate-pressure product.
  • Monitoring respiratory rate during treatment with system of the invention can also be used to monitor the individual's level of rehabilitation. Symptoms in individuals with heart failure are related to an excessive increase in blood lactate during low exercise levels, reduction of oxygen consumption at peak exercise and a disproportionate increase in ventilation at sub-maximal and peak workloads. The increased ventilation assessed by the hyperventilatory response to exercise and the increase in pulmonary dead space leads to rapid and shallow breathing during exercise. Over-active ergoreflex further contributes to this phenomenon.
  • Exercise training has the potential to improve these abnormalities.
  • the changes are achieved primarily through peripheral mechanisms, with little or no effect on resting left ventricular function.
  • Long term follow up of the individual's respiratory rate at sub- maximal exercise is an indicator of a level of reconditioning of the skeletal muscle and the level of rehabilitation of the heart failure individual.
  • Reduction of the respiratory rate of the individual for a given workload is one of the targets of his rehabilitation program. This desired response is critical for the individual's well being sensation, and is of prognostic value.
  • the present invention provides a system for cardiovascular training comprising:
  • the invention provides a method for cardiovascular training of an individual, comprising: (a) providing a system for cardiovascular training, the system comprising: (i) one or more inflatable massaging sleeves; (ii) a device configured to generate one or more signals indicative of a state of vasodilatation; (iii) a pump or compressor configured to deliver a pressurized fluid to the one or more massaging sleeves; and (iv) a processor configured to determine one or more parameters of the inflation of the sleeve based upon the one or more signals and to actuate the pump or compressor to generate an inflation of the one ore more sleeves having the determined one or more parameters.
  • the invention provides a program storage device readable by machine, tangibly embodying a program of instructions executable by the machine to operate a compressor or pump configured to deliver a pressurized fluid to one or more massaging sleeves, comprising:
  • the invention provides computer program product comprising a computer useable medium having computer readable program code embodied therein for operating a compressor or pump configured to deliver a pressurized fluid to one or more massaging sleeves, the computer program product comprising: computer readable program code for causing the computer to determine an operational stage of the pump or compressor in a calculation involving an input from a device configured to generate one or more signals indicative of a state of vasodilatation; and computer readable program code for causing the computer to operate the pump or compressor according to the determined operational stage.
  • Fig. 1 shows schematically a system generally indicated by 1 for cardiovascular training in accordance with one embodiment of the invention.
  • Fig. 2 shows the system 1 in use by an individual 3.
  • the system 1 includes one or more massaging sleeves 2 for applying intermittent pressure to a body limb of the individual.
  • a massaging sleeve 2 is shown adapted for being applied to the individual's leg. This is by way of example only, and the system of the invention may include any number of massaging sleeves adapted for applying intermittent pressure to any one or more body limbs.
  • the system of the invention may include a massaging sleeve on each of the individual's calves, on each of his arms, on one or both thighs, on an arm and a calf, etc.
  • the sleeve or sleeves 2 has an inner surface 4 and an outer surface 6 composed of a flexible, fluid impervious material.
  • the sleeve or sleeves 2 may be divided into a plurality of cells 8 along its length. Eight cells 8, cells 8a to 8h, are shown in the sleeve 2. This is by way of example only, and the sleeve 2 may have any number of cells 8.
  • Each cell 8 is connected to a control unit 10 by a respective hose 12.
  • the hoses 12 may be enclosed in a common sheath 14, as shown in Fig. 2.
  • Sections of the sleeve 2 may be non-inflatable, for example, a section 14 adapted to be applied around the individual's knee.
  • the control unit 10 contains a compressor 16 capable of compressing and pumping ambient air individually into each of the one or more cells 8 of the sleeve 2 via the hoses 12.
  • the control unit 10 is preferably adapted to be worn by the individual, for example on the user's hip, as shown in Fig. 2.
  • the control unit 3 also includes a processor 18 configured to actuate the compressor 16 so that the compressor 16 executes a desired temporo-spatial regime of inflation and deflation of the cells 8.
  • the processor 18 may be configured to operate the compressor 16 so that the compressor generates peristaltic contractions of the sleeve 2. In this regime of contractions, the distal most cell 8a is first inflated and then the next cell 8b is inflated.
  • the cell 8a is then deflated while the cell 8c is inflated. This pattern continues until the proximal most cell 8h is inflated. This pattern of inflation and deflation is then repeated so as to force fluids inside the limb towards the proximal end of the limb.
  • the processor 18 may be configured to actuate the compressor 16 so as to create a regime of inflation and deflation that enhances the flow of the venous blood in the limb.
  • each of the cells 8 of the sleeve 2 are divided into two or more confluent compartments 20 that are inflated and deflated simultaneously, as disclosed in US Patent No. 6,447,467, which is incorporated herein in its entirety by reference.
  • the sleeve may be worn under the individual's clothing, as indicated in Fig. 2 by the cut away trouser leg 22. This allows the individual to be ambulatory while using the system 1.
  • the system 1 may be used while the individual is exercising, as shown in Fig.2.
  • the system 1 further comprises a device 24 for monitoring one or more parameters indicative of the individual's state of vasodilatation.
  • a device 24 for monitoring one or more parameters indicative of the individual's state of vasodilatation.
  • the device 24 is a finger plethysmograph that is applied to a finger of the individual for monitoring the peripheral state of vasodilatation.
  • a reduction in sympathetic tone and improvement in endothelial function have been shown to produce an increase in finger pulse- wave amplitude (PWA) as measured by a plethysmograph.
  • the device 24 may be, for example, a peripheral pulse pressure signal, a pulse oximetry signal, or an impedance meter that monitors changes in blood vessel impedance.
  • the system 1 may optionally include sensors 11 for monitoring one or more parameters indicative of the individual's tolerance to exercise.
  • sensors may include an ECG device for monitoring heart rate, a sphygmomanometer for monitoring blood pressure, and sensor for sensing respiratory rate. Measurements obtained by any one or more of such sensors can be communicated to the processor 18 and stored in the memory 19. Signals generated by the device 24, and/or device 11 when present, are input to the processor 18, either by a wired connection, or more preferably by a wireless connection, as shown in Figs. 1 and 2. For example, communication from the device 24 and/or the device 11 to the processor 18 may utilize a Bluetooth protocol.
  • the device 24 and/or the device 11 is provided with a transceiver 25, and the controller 10 includes a transceiver 27 connected to the processor 18.
  • the processor 18 has a memory 19 for storing measurement values obtained by the devices 24 and 11, as well as the result of any calculations performed by the processor 18.
  • the processor 18 is configured to actuate the compressor 16 so as to execute a control algorithm in which the parameters of the inflation-deflation regime generated in the sleeve 2 are determined based upon signals received from the device 24.
  • the control algorithm allows, preferably in real time, optimization of the pressure profile applied to the body limb by the system 1 in accordance with the individual's exercise level and clinical status.
  • the algorithm may be used for operating the system 1 either in conjunction with simultaneous exercise training, or without simultaneous exercise.
  • the controller 10 may also include an alarm 21 that is activated by the processor when a potentially dangerous situation arises, as explained below.
  • the processor 18 may be configured to store in the memory 19 parameters relating to the use of the system 1. Such parameters may include, for example, treatment duration per session, total treatment duration per day, types of sleeves used, the control algorithm used during each treatment session and the characteristics of the final "optimal stage" that was achieved during that session. Evaluation of these parameters can provide information on the compliance of the individual with a prescribed treatment protocol.
  • the system 1 may include a remotely located service center 17.
  • the processor 18 is configured to communicate with the remotely located service center 17.
  • the service center 17 may be manned or unmanned. Communication between the processor 18 and the service center 17 may be via a wired or a wireless connection.
  • the controller may be adapted for connection to a mobile or wired telephone and data transmitted to the service center 17 over a telephone network.
  • data in the memory 19 may be downloaded onto a PC and transmitted over the Internet to the service station 19.
  • the data received at the service center 17 may be further processed and then communicated to medical caregiver. Analysis of the data may be transmitted to the processor 18 to be made available to the individual or a medical caregiver adjacent to the individual.
  • the processor 18 may use results from the service center to modify the actuation of the compressor 16.
  • the service center 17 may also assist the individual in using the system 1.
  • the processor 18 and/or the service center 17 may be capable of generating a diagnosis responsive to a physiological variable of the user.
  • Fig. 3 shows a control algorithm carried out by the processor 18, in accordance with one embodiment of the invention.
  • the control algorithm of Fig. 3 consists of an integer N of operational stages that are numbered from 1 to N. Each operational stage is characterized by a specific pump rate (frequency), rate of pressure development (dp/dt), maximal pressure developed on the limb, and the duration of the maximal pressure.
  • a typical operation state may be specified by a pump rate of 3 cycles of inflation-deflation of the sleeve per minute, a pressure development rate of 200mm Hg/sec, a maximum inflation pressure of 100 mmHg, and a duration of maximum pressure of 2 seconds.
  • the higher the operational stage number the higher the pump rate and the developed pressure.
  • an initial vasodilatation measurement VDM 0 is obtained by the device 24 and input to the processor 18 with the individual at rest and with the compressor not actuated.
  • This initial vasodilatation measurement VDMo obtained in the absence of applied pressure while the individual is at rest, is referred to herein as the "baseline vasodilatation measurement" , and serves as a reference.
  • VDM 0 When the system 10 is to be activated during exercise, the exercise is started after obtaining VDM 0 with the compressor not activated. After a predetermined amount of time, such as five minutes, of exercise, a vasodilatation measurement is obtained from the device 24 (step 32). This vasodilatation measurement, obtained during exercise in the absence of applied pressure is referred to herein as "the pure exercise” vasodilatation state, and is indicated by VDMex. These first two measurements are stored in the memory 19 of the processor 18 and later transmitted by the communication subsystem to the service center 17. The relationships between these two parameters (VDM 0 and VDM ex ) are important and reflect the rehabilitation staus of the CHF patient.
  • step 34 the operational state n of the algorithm is set to 1, and in step 35 a counter k is set to 1.
  • the processor actuates the compressor 16 to generate the inflation-deflation regime of the sleeve 2 as specified by the present value of the operational state of the algorithm.
  • the generation of the inflation-deflation state specified by the present value of the operational state of the algorithm continues for a predetermined amount of time, for example, such as 5 minutes of operation.
  • step 38 a vasodilatation measurement, indicated by VDM n , is obtained by the device 24 while the system 1 is operating in the current operational stage n and input to the processor 18.
  • step 50 the counter k is increased by 1 and the process returns to step 36. If yes, the operational stage is deceased by 1 to N-I (step 52). The processor 18 then actuates the compressor 16 to generate the inflation-deflation regime of operational stage N-I (step 54). The process terminates when either a predetermined condition is satisfied, for example, after a predetermined amount of time has lapsed, or when the system 1 is turned off.
  • K 2 a second predetermined number
  • step 44 If in step 44 it is determined that the counter k is equal to K 2 , then, the alarm 21 is sounded (step 46) as a warning that the individual's level of exercise should be reduced.
  • the process then continues (step 47).
  • the process terminates when either a predetermined condition is satisfied, for example, after a predetermined amount of time has lapsed, or when the system 1 is turned off.
  • the algorithm preferably specifies a "default mode" based upon pressures, inflation rates, and inflation sequences that have been shown to induce endothelial dependent vasodilatation. The default mode may be determined from previous successful treatments of the same individual.When the VDM signal is lost, the processor 18 automatically switches to this mode.
  • Fig. 4 shows another control algorithm that may be carried out by the processor
  • control algorithm of Fig. 4 also consists of an integer N operational stages that are numbered from 1 to N. Each operational stage is characterized by a specific pump rate, rate of pressure development and maximal pressure developed on the limb. The higher the operational stage number, the higher the pump rate and the developed pressure.
  • the algorithm of Fig. 4 is used when it is possible to identify a target range of VDM measurements that can be considered "normal” or “acceptable” for the individual during a certain level of physical activity. This range is defined by the individual's physician, taking into account the individual's clinical status and the desired level of exercise training. This range is considered the "target goal" of the rehabilitation program, and can be changed according to the individual's progress.
  • the algorithm of Fig. 4 includes several steps in common with the algorithm of
  • step 49 it is determined whether the counter k is equal to a predetermined number K, which may be, for example, 3. If no, then in step 45, the counter k is increased by 1 and the process returns to step 36. If in step 49 it is determined that the counter k is equal to K, then, in step 46, the alarm 21 is sounded as a warning that the individual's level of exercise should be reduced. The process then continues (step 47). The process terminates when either a predetermined condition is satisfied, for example, after a predetermined amount of time has lapsed, or when the system 1 is turned off.
  • K a predetermined number
  • the operational stage at which the individual is within the target range (referred to herein as the "optimal stage") is recorded, stored in the memory 19 and transmitted to the service center 17. If during the rehabilitation program, the "optimal stage" decreases, this trend suggests good adaptation of the individual to the treatment. The level of the exercise can then be increased and accordingly a new target range for the individual can be set.
  • the target range may be defined as a percentage range of a maximal heart rate previously determined for the individual.
  • the system 1 assists the individual to reach the desired designated heart rate despite his inability to perform the needed level of physical activity.
  • the device is not programmed to optimize endothelial dependent vasodilation, it fits into traditional cardiac rehabilitation program concepts.
  • each operational stage may be specified by a pumping rate (f), rate of pressure development (dp/dt), a maximal pressure developed (P), and the duration that the maximal pressure is applied.
  • f rate of pressure development
  • P maximal pressure developed
  • the processor 18 and/or the service center 17 are configured to alter the parameters of the inflation of the one or more operational stages in the algorithm of Fig. 3 or 4, based upon the vasodilation state of the individual and/or based upon previous results obtained on the subject by the system and stored with either the memory 19 or a memory associated with the service center 17.
  • each of the above three parameters are individually determined and optimized.
  • a hierarchical scaling among these variables may be determined.
  • the first one to be determined will be the variable that has the highest chance of affecting the clinical target.
  • the first variable to be manipulated is preferably the dp/dt
  • the second is P
  • the third is f. All the changes are done on top of a baseline operational stage that can be either the "default mode" of operation or the "optimal stage".

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Massaging Devices (AREA)

Abstract

L'invention propose un système et un procédé d'entraînement cardiovasculaire. Le système selon l'invention comprend un ou plusieurs manchons gonflables de massage et un dispositif configuré pour délivrer un ou plusieurs signaux qui indiquent un état de vasodilatation. Un processeur est configuré pour déterminer un ou plusieurs paramètres du gonflement des manchons en fonction d'un ou de plusieurs signaux détectés par le dispositif et pour actionner une pompe ou un compresseur de manière à créer un gonflement du ou des manchons qui présente le ou les paramètres déterminés.
PCT/IL2006/001489 2005-12-27 2006-12-27 Procede et systeme d'entrainement cardiovasculaire Ceased WO2007074451A2 (fr)

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WO2012011927A1 (fr) * 2010-07-23 2012-01-26 Munoz Emilio A Appareil de constriction des jambes pour favoriser la circulation sanguine
RU2519977C1 (ru) * 2013-02-08 2014-06-20 Сергей Петрович Ковалев Способ физической реабилитации больных ишемической болезнью сердца после хирургического лечения с использованием бальных танцев
WO2014200556A1 (fr) * 2013-06-11 2014-12-18 Wright Therapy Products, Inc. Procedes et systemes pour determiner la conformite d'utilisation d'un dispositif de therapie par compression
US9114053B2 (en) 2007-05-08 2015-08-25 Wright Therapy Products, Inc. Pneumatic compression therapy system and methods of using same
US9295605B2 (en) 2013-12-02 2016-03-29 Wright Therapy Products, Inc. Methods and systems for auto-calibration of a pneumatic compression device
US9737238B2 (en) 2012-08-18 2017-08-22 Wright Therapy Products, Inc. Methods for determining the size of body parts as part of compression therapy procedures
US10195102B2 (en) 2012-03-12 2019-02-05 Tactile Systems Technology, Inc. Compression therapy device with multiple simultaneously active chambers
US10292894B2 (en) 2014-02-11 2019-05-21 Tactile Systems Technology, Inc. Compression therapy device and compression therapy protocols
US10470967B2 (en) 2014-01-20 2019-11-12 Tactile Systems Technology, Inc. Bespoke compression therapy device
US10893998B2 (en) 2018-10-10 2021-01-19 Inova Labs Inc. Compression apparatus and systems for circulatory disorders
WO2025173003A1 (fr) * 2024-02-13 2025-08-21 Mego Afek Ac Ltd. Système, dispositif et procédé pour appliquer une thérapie par compression dynamique pour la récupération physique

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US9114053B2 (en) 2007-05-08 2015-08-25 Wright Therapy Products, Inc. Pneumatic compression therapy system and methods of using same
US20110098741A1 (en) * 2008-04-18 2011-04-28 Up-Med Gmbh Apparatus for diagnosis, performance and/or regulation of physiological functions, in particular in an anaesthetized patient
WO2012011927A1 (fr) * 2010-07-23 2012-01-26 Munoz Emilio A Appareil de constriction des jambes pour favoriser la circulation sanguine
US11484462B2 (en) 2012-03-12 2022-11-01 Tactile Systems Technology, Inc. Compression therapy device with multiple simultaneously active chambers
US10195102B2 (en) 2012-03-12 2019-02-05 Tactile Systems Technology, Inc. Compression therapy device with multiple simultaneously active chambers
US9889063B2 (en) 2012-06-11 2018-02-13 Wright Therapy Products, Inc. Methods and systems for determining use compliance of a compression therapy device
US9737238B2 (en) 2012-08-18 2017-08-22 Wright Therapy Products, Inc. Methods for determining the size of body parts as part of compression therapy procedures
US11471070B2 (en) 2012-08-18 2022-10-18 Tactile Systems Technology, Inc. Methods for determining the size of body parts as part of compression therapy procedures
RU2519977C1 (ru) * 2013-02-08 2014-06-20 Сергей Петрович Ковалев Способ физической реабилитации больных ишемической болезнью сердца после хирургического лечения с использованием бальных танцев
WO2014200556A1 (fr) * 2013-06-11 2014-12-18 Wright Therapy Products, Inc. Procedes et systemes pour determiner la conformite d'utilisation d'un dispositif de therapie par compression
AU2013392051B2 (en) * 2013-06-11 2017-06-08 Tactile Systems Technology, Inc Methods and systems for determining use compliance of a compression therapy device
EP3007672A4 (fr) * 2013-06-11 2017-02-01 Wright Therapy Products Inc. Procedes et systemes pour determiner la conformite d'utilisation d'un dispositif de therapie par compression
CN105530905A (zh) * 2013-06-11 2016-04-27 赖特治疗产品股份有限公司 用于确定压缩治疗设备的使用依从性的方法和系统
AU2017225055B2 (en) * 2013-06-11 2019-07-18 Tactile Systems Technology, Inc Methods and systems for determining use compliance of a compression therapy device
EP3528258A1 (fr) * 2013-06-11 2019-08-21 Tactile Systems Technology, Inc. Procédés et systèmes pour déterminer la conformité d'utilisation d'un dispositif de thérapie par compression
US9295605B2 (en) 2013-12-02 2016-03-29 Wright Therapy Products, Inc. Methods and systems for auto-calibration of a pneumatic compression device
US10470967B2 (en) 2014-01-20 2019-11-12 Tactile Systems Technology, Inc. Bespoke compression therapy device
US10292894B2 (en) 2014-02-11 2019-05-21 Tactile Systems Technology, Inc. Compression therapy device and compression therapy protocols
US10893998B2 (en) 2018-10-10 2021-01-19 Inova Labs Inc. Compression apparatus and systems for circulatory disorders
WO2025173003A1 (fr) * 2024-02-13 2025-08-21 Mego Afek Ac Ltd. Système, dispositif et procédé pour appliquer une thérapie par compression dynamique pour la récupération physique

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