INTERMITTENT COMPRESSION SYSTEM FOR VENO-LYMPHATIC CARE

20210290477 · 2021-09-23

    Inventors

    Cpc classification

    International classification

    Abstract

    An intermittent compression system for veno-lymphatic care of at least one limb of a person to be treated comprising: an inelastic inflatable garment having at least one independent inflatable chamber, an inflator, in fluid communication with the inflatable chamber, at least one pressure regulator, to control the inflating pressure of the inflatable chambers, the system comprising at least one flowmeter, adapted to be in fluid communication with at least one of the garment chambers.

    Claims

    1. An intermittent compression system for veno-lymphatic care of at least one limb of a person to be treated comprising: i. an inelastic inflatable garment comprising at least one independent inflatable chamber; ii. an inflator, in fluid communication with the inflatable chamber; iii. at least one pressure regulator, to control the inflating pressure of the inflatable chambers; wherein the system comprises at least one flowmeter, adapted to be in fluid communication with at least one of the garment chambers.

    2. The intermittent compression system of claim 1, comprising a volumetric comparator designed to calculate an inflating air volume difference required to reach a target pressure between two cycles to be compared.

    3. The intermittent compression system of claim 1, wherein the garment comprises a plurality of juxtaposed independent chambers connected on one hand to the inflator and, on the other hand, to each of the inflatable garment chambers and wherein the volumetric comparator is designed to calculate and indicate the volume evolution for a plurality of chambers.

    4. The intermittent compression system of claim 1, further comprising a calculator designed to determine compression values and/or an intermittent inflating cycle that allows a volume reduction of at least the distal areas of the limb treated with the garment.

    5. The intermittent compression system of claim 1, wherein the inflatable garment is a boot, or a shoe, or a legging, or a sleeve, or a glove, or a vest, or a mask.

    6. The intermittent compression system of claim 1, wherein the inflating fluid is air and the inflator is a compressor.

    7. A method of inflating for the intermittent compression system as claimed in claim 1, comprising the following steps: i. a step during which at least one chamber of the inflatable garment is inflated at a target inflating pressure with the inflator; ii. a step during which the fluidic volume required to reach the target pressure within the chamber is measured with the flowmeter; iii. a step during which the chamber is deflated by evacuation of the inflating fluid. iv. a further step during which the chamber is inflated at a target inflating pressure with the inflator; v. a step during which the fluidic volume required to reach the target pressure within the chamber is measured with the flowmeter; vi. a stage during which the values of the fluidic volumes required to reach the target pressure are compared with the volumetric comparator.

    8. The method of claim 7, wherein the comparison between the values of inflating air volumes is carried out between two or more successive cycles.

    9. The method of claim 7, wherein the comparison between the values of inflating air volumes is carried out between two or more compression system operating periods.

    10. The method of claim 7, further comprising a step during which the volumetric comparator calculates the volume evolution for a plurality of chambers.

    Description

    DESCRIPTION OF THE FIGURES

    [0043] All implementation details are given in the following description, complemented by FIGS. 1 to 6, provided by way of nonlimiting example only, and in which:

    [0044] FIG. 1 is a schematic representation of an example of intermittent compression system comprising a single chamber;

    [0045] FIG. 2 is a graph showing an example of an intermittent treatment cycle carried out with a system such as the one in FIG. 1;

    [0046] FIG. 3 is a schematic representation of an example of an intermittent compression system comprising a plurality of independent chambers disposed one after the other to create a treatment garment;

    [0047] FIG. 4 is a graph showing an example of an intermittent treatment cycle carried out with a system such as the one in FIG. 3;

    [0048] FIG. 5 is a schematic representation of an example of an intermittent compression system comprising a plurality of chambers, one or several volume comparators and a calculator;

    [0049] FIG. 6 illustrates another example of intermittent compression system comprising a plurality of chambers.

    DETAILED DESCRIPTION OF THE INVENTION

    [0050] Principle of the Invention

    [0051] On the premise that the temperature during an intermittent compression session does not vary significantly, the Boyle-Mariotte law, a simplified version of the ideal gas law PV=nRT (where P=Pressure, V=Volume, n=amount of substance, R=ideal gas constant, and T=Temperature) applies.

    [0052] This law indicates that, once the segment is under pressure (Ps), the ratio between this pressure and the total volume (Vt) of the segment is constant: Ps×Vt=constant.

    [0053] As Intermittent compression garments are inelastic, during the treatment, the segment total volume (Vt) is equal to the volume of the limb (Vl) in the segment+the volume of air sent by the pump (Va): Vt=Vl+Va.

    [0054] As The intermittent compression system is designed to send a given pressure into each segment (Ps), a variation in the limb volume (Vl) is therefore automatically compensated by the delivery of a variable volume of air (Va) to maintain a constant ratio: Ps×(Vl+Va)=constant.

    [0055] The compression system described hereafter thereafter uses this concept in order to give an indication on volume variation of the part of the limb contained in each segment of the sleeve or boot and/or the total volume of the limb, either between two cycles and/or after a defined number of cycles, and/or at the end of the session.

    [0056] Moreover, the described system includes a measuring element that allows the measurement, for each garment segment, of the volume of air required to reach the desired pressure. According to the Boyle-Mariotte law, if, between two cycles, this volume increases, we can conclude that the volume of the limb contained in this segment has decreased, and vice versa.

    [0057] In a simple version, the system visually indicates the evolution of the limb volumetry. The indicators provide information on the evolution of the patient's limb volume in the segment: for example, a “−” symbol or a green light to indicate volume reduction. The “=” symbol or an orange or white light means no significant change in the limb volume. The “+” symbol or red light means an increase in the limb volume. The indicators can also be screens displaying the exact variation of the volume. Minor variations, of about 1% or even 0.5%, are preferably detectable.

    [0058] This system means it is possible to, either adapt the compression values during the treatment or stop the treatment if the effects are negative (typically a volume increase in the most distal segment).

    [0059] In a more elaborate version, the device provides a direct interface between the volumetric measurement and the adjustment of the pressure in each of the segments and/or the duration of the cycles.

    [0060] Based on the volume changes during the previous cycle(s), a calculator allows the automatic adjustment of the volume of air sent into each segment and/or the duration of the cycles. The calculator is designed for the volume reduction to happen in a distal/proximal way. Table 1 below presents some scenario examples.

    TABLE-US-00001 TABLE 1 Evolution of the volume of air required to main- tain a constant pressure in one or more chambers Assessment System adjustments Reduction of volume in The lymph and other Step 1: the system reduces the pressure C1 at any moment of a fluids forming the in segments C2 to C8. If this action leads session. edema are displaced to a volume increase in C1, after a few towards the distal cycles, the system progressively re- extremity of the increases the pressure in C2 to C8 until limb: pressures in it finds the best setting. If the volume in segments C2 to C8 C1 doesn't increase, the system moves are maybe too high. on to stage 2. Step 2: the system deactivates the inflating in segments C2 to C8. If this action leads to a volume increase in C1, after a few cycles, the system progressively re-increases the pressure in C2 to C8 until it finds the best setting. If this action doesn't lead to increase the volume in C1, the system stops. The volume in an The lymph and other The system increases the distal intermediate segment fluids forming the pressures of the segment where the decreases but the edema are blocked volume decreased and reduces the volumes in the along the limb: the proximal pressures to obtain a new adjacent segments distal/proximal compression profile. increase. graduation of the compression must be reviewed. The volumes increase The compression The system modifies the pressures in the in a distal/proximal way profile is apparently different chambers while keeping the but the total gain in good but the com- same compression profile to optimize the volume is not high. pression values are limb volume reduction. Once the best too low or too high compression profile for this patient has or the cycle rhythm been defined, the system modifies the is not adapted. duration of the cycles to find best efficiency. The volumes increase The compression None in a distal/proximal way profile is good. and the total gain in volume is high.

    [0061] The autonomous compression system provides a better adaptation of compression to the specific needs of each patient in order not only to optimize the effects of each session. It also means it is possible to determine, an ideal compression profile for each patient. This ideal dosage profile may be used later to define a more efficient compression garment.

    [0062] Although the main objective of the intermittent compression system is not to measure the volume of a limb, or a part of it, but to measure the evolution of a volume (difference between final and initial volumes) during the treatment, the system can potentially be used before the treatment, on the limb not affected by the edema, to define one or more reference values. This or these reference values can then be integrated into the treatment objective as an excess volume reduction target to be reached. These values can also be used as a basis for the adjustment of the indicators (A 1% volume reduction at each cycle can be conceivable on a limb with a very large excess volume and long cycles. For a patient with a lesser excess volume, the indication of a 1% volume reduction can be possible over several cycles).

    [0063] In a variant, the system can also provide a phase where the measurements of the limb to be treated are calculated. The total volume of the chamber at the target pressure corresponds to the sum of the volume of air sent by the pump and measured by the flowmeter with the volume of the limb in the chamber.

    [0064] FIG. 1 is a schematic representation of a first example of implementation of an intermittent compression system 1. System 1 includes an inflator 4 connected to a garment 2 by means of an inflating connection 9. A pressure regulator 5 and a flowmeter 6 are positioned between the pump and the garment 2.

    [0065] Advantageously the inflator is a pump, with or without an intermediate tank. The inflator and regulator are positioned in a known manner to allow the intermittent inflating and deflating of garment 2. A target pressure, fixed or variable, is determined.

    [0066] The intermittent compression treatment dosage is the result of the compression value(s) applied to the limb, of the cycles' frequency and duration, and of the total duration of the session.

    [0067] The pressure regulator 5 controls the pressure transmitted to the garment 2. The flowmeter 6 measures the volume of air transmitted to the garment until the target pressure level is reached.

    [0068] In the FIG. 1 example, the garment 2 is a boot that includes a single inflating chamber 3. This configuration allows the inflation of the garment all at once, with pressure applied in a uniform way on the whole limb 10 to be treated, in this case the leg of the user.

    [0069] FIG. 2 is a graph showing an example of an intermittent inflating/deflating treatment cycle applied to a garment. The graph indicates the time on the horizontal axis and compression values on the vertical axis. In this example, the cycle includes a target compression value of 50 hPa, corresponding to the maximum pressure applied to the garment. The cycle includes a minimal compression value or deflating pressure of 20 hPa. Alternatively, the minimum value can be lower.

    [0070] FIGS. 3 and 4 show an alternative embodiment in which the garment 2 includes a plurality of chambers 3, indicated C1 to C8 on the figure. The multiple chambers make it possible to perform inflating/deflating cycles with different target pressures in different chambers, for example with a higher value in the distal area or at the extremity of the limb (the foot in this case) and getting weaker towards the proximal area (the body of the user). This type of treatment improves, for example, the draining of body fluids from the distal area to the proximal area of the body.

    [0071] In this embodiment, the inflator 4 allows the inflation of the different chambers 3 of the garment 2, either alternatively, at the same time, or combining these two modes. The figure illustrates a plurality of regulators 5 and flowmeters 6, that is each in relation with each chamber 3. In a variant, the system uses a single regulator 5 and/or a single flowmeter 6, with a selector able to send the air flux towards one of the chambers.

    [0072] In the two previous examples, the flowmeter 6 provides the user and/or the prescriber with the data corresponding to the volume of air delivered to a chamber to inflate the latter to the target pressure, during a given cycle. By comparing the values, the user or the prescriber can observe the effect of the treatment on the volume of the limb. For example, the higher the volume of air required (at iso-pressure) the higher the volume of the chamber. As the external dimension of the chamber is fixed, the increase in the volume of air means a decrease in the volume of the limb surrounded by the chamber.

    [0073] FIG. 5 illustrates another alternative embodiment in which a volumetric comparator determines the evolution either according to the reference cycle, a duration, or other, for one or more chambers of the system if the system includes several chambers. As illustrated, the system can also provide a calculator 8, designed to determine the compression values and/or intermittent inflating cycles that allow a volume reduction of at least the limb distal areas by the garment.

    [0074] FIG. 6 illustrates another embodiment in which all the elements of the intermittent compression system 1 are integrated in a casing. In this way we obtain a system that is compact and easy to transport. A connecting tube 9 connects the inflator 4 to a selector 11 which can direct the flow towards a selected chamber. A pressure controller 5, a flowmeter 6 and a volumetric comparator are also provided. A plurality of external connecting tubes 9 connect each chamber to the corresponding outlets on the casing.

    [0075] According to the invention, the system is advantageously used for the implementation of an intermittent inflating process, including the following steps: [0076] i. a step during which at least one chamber 3 of the inflatable garment 2 is inflated at a target inflating pressure with the inflator 4; [0077] ii. a step during which the fluidic volume required to reach the target pressure within the chamber 3 is measured with the flowmeter 6; [0078] iii. a step during which the chamber 3 is deflated by evacuation of the inflating fluid; [0079] iv. a further step during which the chamber 3 is inflated at a target inflating pressure with the inflator 4; [0080] v. a step during which the fluidic volume required to reach the target pressure within the chamber is measured with the flowmeter 6; [0081] vi. a step during which the values of the fluidic volumes required to reach the target pressure are compared with the volumetric comparator 7.

    [0082] According to this process, the comparison between the values of the volumes of air required for the inflating can be compared between two or more successive cycles and/or between two or more periods of operating time of the compression system.

    [0083] If the system includes several chambers, the process can be set up in a way in which the volumetric comparator calculates the evolution of the volume for a plurality of chambers.

    LIST OF REFERENCE NUMBERS

    [0084] 1 Intermittent compression system [0085] 2 Garment [0086] 3 Chamber [0087] 4 Inflator [0088] 5 Pressure regulator [0089] 6 Flowmeter [0090] 7 Volumetric comparator [0091] 8 Calculator [0092] 9 Inflating connector [0093] 10 Limb to be treated [0094] 11 Selector