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WO2016074740A1 - Procédé et dispositif pour le traitement d'un lymphoedème - Google Patents

Procédé et dispositif pour le traitement d'un lymphoedème Download PDF

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Publication number
WO2016074740A1
WO2016074740A1 PCT/EP2014/074593 EP2014074593W WO2016074740A1 WO 2016074740 A1 WO2016074740 A1 WO 2016074740A1 EP 2014074593 W EP2014074593 W EP 2014074593W WO 2016074740 A1 WO2016074740 A1 WO 2016074740A1
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WO
WIPO (PCT)
Prior art keywords
body portion
pressure
garment
layer
component sheet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2014/074593
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English (en)
Inventor
Jean-Baptiste VALSAMIS
Giovanni-Paolo BELGRADO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Universite Libre de Bruxelles ULB
Original Assignee
Universite Libre de Bruxelles ULB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universite Libre de Bruxelles ULB filed Critical Universite Libre de Bruxelles ULB
Priority to PCT/EP2014/074593 priority Critical patent/WO2016074740A1/fr
Publication of WO2016074740A1 publication Critical patent/WO2016074740A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0029—Arm or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0039—Leg or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0071—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a resistor, e.g. near the spot to be heated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0077—Details of power supply
    • A61F2007/0078—Details of power supply with a battery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0086—Heating or cooling appliances for medical or therapeutic treatment of the human body with a thermostat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0091—Heating or cooling appliances for medical or therapeutic treatment of the human body inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0094—Heating or cooling appliances for medical or therapeutic treatment of the human body using a remote control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0225—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0225—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof
    • A61F2007/0228—Compresses or poultices for effecting heating or cooling connected to the body or a part thereof with belt or strap, e.g. with buckle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0244—Compresses or poultices for effecting heating or cooling with layers

Definitions

  • the invention relates to a method for treating lymphedema for cosmetic and/or therapeutic purposes and to a device for performing the method.
  • lymphatic system collects and filters the interstitial fluid of the body.
  • Lymphedema also known as “lymphoedema” or “lymphatic obstruction”
  • Lymphedema is an accumulation of interstitial colloid in the extracellular space that causes swelling, most often in the arms and/or legs and occasionally in other portions of the body due to a compromised lymphatic system.
  • Lymphedema carries the constant risk of developing an uncontrolled infection in the affected body portions of the living being. Considering the swelling of body portions and the health risks related to lymphedema, treatment of lymphedema may be desired for cosmetic and/or therapeutic purposes.
  • This patent application does not relate both heating and a compression therapy to the treatment of lymphedema.
  • heating is described to provide temperature therapy while the application of pressure/compression is described as a lymphedema treatment.
  • WO Patent Application Publication No. 02/19954 describes a method and device of use for lymphatic drainage.
  • the device an elastic brace, is able to produce discrete areas of varied high and low pressure points on the skin and underlying tissue of a body portion when the brace is in place.
  • heated liquid the treated body portion can be heated.
  • a link between heating and lymphatic drainage is not mentioned in this patent application.
  • the heating is described to be desirable if a heated therapeutic effect is wanted.
  • the nature of this heated therapeutic effect is however not explained.
  • the mentioned prior art documents do not specifically combine heating with a compressive treatment for the treatment of lymphedema.
  • pressure variations being exerted by the body portion itself when being pressurized by an external pressure, and the use thereof, are neglected in lymphedema treatment methods.
  • An aspect of the present invention provides a method for treating lymphedema for cosmetic and/or therapeutic purposes, comprising the steps of:
  • the compressive pressure and heat are applied to a body portion using a garment which is configured to fit around the body portion, by positioning the garment on the body portion and adjusting the circumference of the garment while being positioned on the body portion to apply a desired compression profile to the body portion, and applying heat to the body portion by heating means comprised in the garment.
  • the device corresponds to a garment comprising a multi-component sheet configured for being applied to a body portion.
  • the multi-component sheet comprises at least one rigid outer layer and at least one softer inner layer, the rigid layer being extended throughout the sheet for maintaining a substantially constant cross- sectional perimeter of the multi-component sheet and said softer layer arranged at an inner side of the multi-component sheet such that, in use, the softer layer is interposed between the body portion and the rigid layer, wherein the softer layer is configured to enable close contact between the rigid layer and said body portion.
  • the garment comprises a temperature control means including heating means for setting a temperature at the inner side of the multi-component sheet between 32.5 and 40 °C, preferably at least 36 °C, more preferably at least 36.5 °C, preferably at most 40 °C, more preferably at most 39.5 °C, wherein the heating means is configured to be interposed between the rigid layer and the body portion.
  • the rigid layer of the multi- component sheet possesses a rigidity or stiffness higher than the rigidity or stiffness of a body portion, which enables the capturing of an internal pressure exerted at the skin surface by arterial pulsations and/or muscle action of a body portion while performing an externally applied circumferential pressure by the multi-component sheet.
  • the multi- component sheet is configured to exert an externally applied circumferential pressure at pressure levels of at least 0.5 mm Hg, preferably at least 15 mm Hg, more preferably at least 28 mm Hg, and at most 200 mm Hg, preferably at most 100 mm Hg and more preferably at most 80 mm Hg and for the capturing of said internal pressure for pressure levels of at least 0.5 mm Hg, preferably at least 10 mm Hg, more preferably at least 20 mm Hg, and at most 260 mm Hg and preferably at most 90 mm Hg.
  • the presence of heating means and a multi-component sheet enables the garment to apply heat as well as compressive pressure to a body portion for performing the lymphedema treatment method. Furthermore, the configuration of the garment enables the application of the heat and pressure levels desired for performing the lymphedema treatment method. Description of figures
  • Figure 1 shows a possible design of a garment for the treatment of lymphedema being applied to a leg of a patient, according to embodiments of the present invention
  • Figure 2 shows a possible design of a garment for the treatment of lymphedema being applied to an arm of a patient, according to embodiments of the present invention.
  • the present invention concerns a method and device for treating lymphedema for cosmetic and/or therapeutic purposes.
  • a compartment refers to one or more than one compartment.
  • “About” as used herein referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of +/-20% or less, preferably +/-10% or less, more preferably +/-5% or less, even more preferably +/- 1 % or less, and still more preferably +/-0.1 % or less of and from the specified value, in so far such variations are appropriate to perform in the disclosed invention.
  • the value to which the modifier "about” refers is itself also specifically disclosed.
  • the invention provides a method for treating lymphedema for cosmetic and/or therapeutic purposes, comprising the steps of:
  • body portion is used as a general term to designate a portion of the body of a living being.
  • the combination of applying heat and compressive pressure to a body portion provides an effective treatment of lymphedema, as revealed by thorough studies carried out by the present inventors.
  • the present inventors found that increased temperature liquefies the edema made up of proteins and water, which at the normal skin temperature of about 32.5°C is in a gel state.
  • the skin temperature increase causes vasodilation of the cutaneous arteriovenous capillaries, which is accompanied by an increased capillary permeability. Even though vasodilation is an a priori aggravating condition for edemas, it has surprisingly been found to nevertheless become beneficial when a suitable compressive pressure is exerted in order to increase the tissue pressure and inverse the net driving force in the Starling equation of fluid movement across capillary membranes to favor absorption processes by the capillaries.
  • the temperature increase is provided preferably in combination with the application of a compressive pressure at the skin surface.
  • the combination of higher temperature and pressure has a synergistic effect leading to an increased absorption of edema matter, and particularly of proteins in addition to water.
  • temperature and compressive pressure can also be applied sequentially next to simultaneously.
  • lymphedema treatment it may prove beneficial for lymphedema treatment to first apply heat to the skin surface of a body portion, liquefying the edema matter, after which a compressive pressure is combined with the heat to evacuate the (solubilized) local interstitial colloid.
  • the applied compressive pressure at the skin surface of the body portion is the result of a circumferential pressure, externally applied to a body portion of a patient, and an internal pressure, the internal pressure being exerted at the skin surface by arterial pulsations and/or muscle action of the body portion.
  • the applied temperature for heating the skin surface ranges from 32.5 to 40 °C, preferably from 36 to 39.5 °C, more preferably from 36 to 38 °C, and most preferably corresponds to a temperature slightly above 37 °C.
  • Increasing the temperature at the skin surface above the normal skin temperature of about 32.5 °C will result in the liquefaction of the edema (proteins), as discussed above. At temperatures above 40°C, a patient being treated for lymphedema will feel a discomfort.
  • the externally applied circumferential pressure is at least 10 mm Hg, preferably at least 28 mm Hg, more preferably at least 40 mm Hg, most preferably at least 45 mm Hg, and at most 90 mm Hg, preferably at most 80 mm Hg and more preferably at most 70 mm Hg.
  • the internal pressure is at least 20 mm Hg, preferably at least 35 mm Hg, at most 260 mm Hg, preferably at most 100 mm Hg, more preferably at most 90 mm Hg.
  • the concept of internal pressure can be explained as follows.
  • the internal pressure is the pressure being exerted at the skin surface by arterial pulsations and/or muscle action of a patient.
  • Arterial pulsations are rhythmic expansions of arteries.
  • the pressure of circulating blood on the arteries results in an arterial pressure.
  • a pressure wave is generated, resulting in an arterial pressure waveform.
  • the arterial pressure waveform results in pressure changes at the skin surface.
  • an external pressure is applied to a body portion of a patient, the surface veins, arteries, muscles, and other soft tissue is compressed, causing the circulating blood being forced through narrower circulatory channels, increasing the arterial pressure. Movement of the body of a patient involves muscle action. Muscle action will result in pressure changes at the skin surface.
  • the internal pressure is in fact a time- and spatially-varying pressure, due to the arterial pulsations and the activity of muscles linked to body movement.
  • the total compressive pressure being applied at the skin surface of a body portion being the result of an externally applied pressure and internal pressure, is thus also a time- and spatially- varying pressure, the pressure fluctuating due to arterial pulsations and muscle action.
  • the time- and spatially-varying total compressive pressure at the skin surface preferably varies between amplitudes falling in the range between 5 mm Hg and 350 mm Hg, with amplitudes of preferably at least 10 mm Hg, more preferably at least 15 mm Hg, most preferably at least 35 mm Hg, utmost preferably at least 40 mm Hg, and with amplitudes of preferably at most 250 mm Hg, more preferably at most 100 mm Hg, most preferably at most 90 mm Hg.
  • the high pressure peaks at the skin surface which can reach values of 250 to 350 mm Hg, only occur for very short instances, due to the rhythmic nature of arterial pulsations and the intermittent nature of muscle action. Therefore, the high pressure peaks cannot create damage on microcirculation in a treated body portion. Instead, the time- and spatially- varying pressure will realize a massage effect on the treated body portion, effectively evacuating local interstitial colloid.
  • the compressive pressure and heat are applied to a body portion using a garment which is configured to fit around the body portion, by positioning the garment on the body portion and adjusting the circumference of the garment while being positioned on the body portion to apply a desired compression profile to the body portion, and applying heat to the body portion by heating means comprised in the garment.
  • a garment enables the application of both heat and compressive pressure to a body portion for lymphedema treatment while the body portion maintains a sufficient range of motion.
  • suitable garments are sleeves and braces.
  • Garments may be provided with fastening means, such as a fastening strap combined with a ring, the ring having an aperture capable of receiving a free end of the fastening strap through it, when the garment is wrapped. Such fastening means can aid in the configuration of a garment to fit a body portion. Resistors may be used as heating means.
  • the operation of adjusting the circumference of the garment comprises setting the circumference of the garment to defined values at sections of the body portion.
  • the desired circumference of the garment which may vary at different portions of the garment, depends on the compression profile desired by the method of the present invention, on material properties of the garment and on the dimensions of the treated body portion. Along the distance of a treated body portion, sections of the body portion having a smaller diameter will require a smaller circumference of the garment to obtain a defined tension or pressure value compared to sections of the same body portion having a larger diameter. As long as the elasticity or the tension of the garment is uniform, the application of a compressive pressure by the garment results in a pressure gradient due to Laplace law.
  • the circumference of a body portion such as a leg or an arm, increases from the distal to the proximal side, resembling a truncated cone.
  • a pressure gradient may be achieved by tightening the straps of a garment harder, thus achieving a higher tension, at the distal part compared to the proximal part of a treated body portion.
  • the invention provides a device for performing the lymphedema treatment method.
  • the device corresponds to a garment comprising a multi- component sheet configured for being applied to a body portion.
  • the multi-component sheet comprises at least one rigid outer layer and at least one softer inner layer, the rigid layer being extended throughout the sheet for maintaining a substantially constant cross- sectional perimeter of the multi-component sheet and said softer layer arranged at an inner side of the multi-component sheet such that, in use, the softer layer is interposed between the body portion and the rigid layer, wherein the softer layer is configured to enable close contact between the rigid layer and said body portion.
  • the garment comprises a temperature control means including heating means for setting a temperature at the inner side of the multi-component sheet between 32.5 and 40 °C, preferably at least 36 °C, more preferably at least 36.5 °C, preferably at most 40 °C, more preferably at most 39.5 °C, wherein the heating means is configured to be interposed between the rigid layer and the body portion.
  • the rigid layer of the multi- component sheet possesses a rigidity or stiffness higher than the rigidity or stiffness of a body portion, which enables the capturing of an internal pressure exerted at the skin surface by arterial pulsations and/or muscle action of a body portion while performing an externally applied circumferential pressure by the multi-component sheet.
  • the multi- component sheet is configured to exert an externally applied circumferential pressure at pressure levels of at least 0.5 mm Hg, preferably at least 15 mm Hg, more preferably at least 28 mm Hg, and at most 200 mm Hg, preferably at most 100 mm Hg and more preferably at most 80 mm Hg and for the capturing of said internal pressure for pressure levels of at least 0.5 mm Hg, preferably at least 10 mm Hg, more preferably at least 20 mm Hg, and at most 260 mm Hg and preferably at most 90 mm Hg.
  • the presence of heating means and a multi-component sheet enables the garment to apply heat as well as compressive pressure to a body portion for performing the lymphedema treatment method.
  • the configuration of the garment enables the application of the heat and pressure levels desired for performing the lymphedema treatment method.
  • the rigid layer provides a non-stretch or low-stretch layer when the sheet is wrapped around a body portion, such that the cross-sectional perimeter of the wrapped sheet remains substantially unaltered once tightened by fastening means. This is important for obtaining a compressive pressure at the skin surface.
  • the rigid layer further acts as support for the other layers of a multi-component sheet.
  • fastening means such as fastening straps combined with rings, are advantageously attached to the inelastic layer situated at the outer side of the multi-component sheet.
  • the heating means is interposed between the rigid layer and the treated body portion.
  • the heating means may be situated between the rigid outer layer and the softer inner layer of a multi-component sheet being composed of those two layers.
  • Heating means form part of a temperature control system, preferably including a controller and possibly a preferably portable (electrical) energy source, such as a battery.
  • the temperature control system is arranged to control and set the temperature at the inner side of the sheet to temperatures between 32.5 and 40 °C.
  • increasing the temperature at the skin surface above the normal skin temperature of 32.5 °C will result in the liquefaction of the edema (proteins) while at temperatures above 40 °C, a patient being treated for lymphedema will feel a discomfort.
  • the concept of internal pressure at the skin surface due to arterial pulsations and/or muscle action has been explained above.
  • the rigidity or stiffness of the rigid layer has to be higher than the rigidity or stiffness of a body portion being treated.
  • the garment is able to provide the required pressure levels at the skin surface of the treated body portion, which is meaning both the required externally applied pressure levels and the required internal pressure levels, for performing the lymphedema treatment method of the present invention.
  • the desired pressure levels can be patient-specific as well as body-portion-specific.
  • the configuration of the multi-component sheet involves controlling the circumference of the garment.
  • the configuration of the garment may also involve choosing the number of rigid and outer layers for the multi-component sheet and selecting materials with specific characteristics for the rigid and softer layers.
  • garments according to the present invention are preferably portable, since a patient's movement causes muscular pressure increase, which increases the internal pressure and makes lymphedema treatment more effective.
  • the rigid layer is preferably formed such as to allow a movement of a body portion, such as knee or elbow bending.
  • the garment may comprise a successive disposition of a plurality of multi-component sheets flexibly attached to one another to provide for body portion movement, with each multi-component sheet capable of being wrapped around the body portion.
  • the pressure gradient will push the edema matter in the desired direction (i.e., towards the proximal side of a treated body portion of a patient). If the cone-like shape of a body portion of a living being disappears due to swelling caused by the lymphedema, the pressure gradient due to Laplace law is diminished or absent. In the latter case, the pressure gradient can be achieved by applying a higher tension at the distal side of a body portion compared to the proximal side, by tightening the multi-component sheet in a greater extent on the distal side compared to the proximal side of the body portion. Alternatively, a pressure gradient can be created by choosing different materials for the softer layer along the length of the multi- component sheet.
  • the softer layer will be composed out of different sections from its distal to its proximal end, each section having different material properties. Since the material properties of such a multi-component sheet will differ from the proximal to the distal side, a pressure gradient can be applied on the treated body portion, even when the tension applied by the multi-component sheet is constant along the treated body portion. Therefore, the softer layer sections of such a multi-component sheet being closer to the distal part of the treated body portion should have a higher visco-elasticity than the softer layer sections being closer to the proximal part of the treated body portion.
  • the evacuation of local interstitial colloid will cause the treated body portion to deswell.
  • the distance between the skin surface and the sheet will increase when the body portion deswells, resulting in a loss of fitting and a reduced massage effect.
  • the externally applied circumferential pressure will still be in place, which will impede the drained interstitial colloid to return to the edema, yet will not continue to reduce the edema. Therefore, when the body portion is deswelled to a certain extent, the multi- component sheet is preferably re-fitted to the new dimensions of the treated body part by tightening the sheet. For example, the sheet should be re-fitted approximately each half hour.
  • the applied garment should overlap as little as possible at that cross-sectional area.
  • An overlapping part of the garment will increase locally (longitudinally) the radius of curvature, leading in a reduction in pressure and thus resulting in a lower pressure compared to the pressure at the skin surface at level of the non-overlapping part of the garment. Therefore, the garment of the present invention is preferably tailored to the dimensions of the treated body part, avoiding substantial overlapping of the garment while the garment is tightened to achieve the compressive pressure levels desired in the method of the present invention.
  • the rigid layer is made of a non-stretch or short-stretch material that can be stretched by maximum 100%, preferably by maximum 75%, more preferably by maximum 50%, most preferably by maximum 25% along the direction of the circumference of the body portion when using the tension required to secure the garment.
  • the rigid layer requires a force of at least 1 N, preferably at least 2 N, more preferably at least 5 N to stretch the rigid layer by 1 % per meter width along the direction of the circumference of the body portion.
  • a rigid layer with a width of 10 cm can be stretched by 1 % with a force of at least 0.1 N, preferably at least 0.2 N, more preferably at least 0.5 N while a rigid layer with a width of 5 cm can be stretched by 1 % with a force of at least 0.05 N, preferably at least 0.1 N, more preferably at least 0.25 N.
  • the rigid layer may be made of a nonwoven fabric made of synthetic or natural fibers. It will be convenient to note that a variety of other materials may be used as rigid layer.
  • the softer layer is preferably made out of an elastic or visco-elastic material, for which the material properties are the following: the compressive modulus, as determined in a direction perpendicular to the plane of the softer layer, is at most 500 MPa, preferably at most 100 MPa, more preferably at most 10 MPa and most preferably at most 1 MPa; the relaxation constant is at most 20 s, preferably at most 10 s, and at least 1 ms, preferably at least 2 ms, and most preferably at least 20 ms; and the density is at least 10 kg/m 3 , preferably at least 15 kg/m 3 and at most 150 kg/m 3 , preferably at most 100 kg/m 3 .
  • the material properties of the softer layer are chosen in function of the softer layer's ability to assist in obtaining pressure variations at the skin surface by exploiting the arterial blood pressure variation. Particularly advantageous are softer layers having such visco-elastic properties that cause a phase shift in skin pressure variations relative to the arterial blood pressure.
  • the relaxation constant of at least 1 ms endows the softer layer with a considerable viscous component.
  • Softer layers can be made of one or a combination of known padding materials, such as, but not limited to: a high-density foam, such as a polyurethane foam, a polyethylene foam, an appropriate cellular material, a silicone gel, and a spacer fabric. They can as well be formed of different, stacked layers. Since lymphedemas may differ in their respective water content, it will be convenient to note that resilient layers having different mechanical properties may be selected to treat the different edemas.
  • the temperature control means comprises one or more temperature gauges arranged at the inner side of the multi- component sheet.
  • the heating means of the garment form part of a temperature control system, which also contains a controller.
  • the controller is connected to the heating means through a cable.
  • the controller is arranged to control the temperature at the inner side of the multi-component sheet by controlling the actuation of the heating means.
  • Temperature control can be effected by providing one or more temperature gauges, such as thermocouples, in or at the resilient layers, and electrically connected to the controller.
  • the controller can have a user interface, such as a control knob, for adjusting the temperature as desired.
  • the one or more temperature gauges can be provided inside the multi-component sheet, for example between softer layers, in a composition of the multi- component sheet containing multiple softer layers. Alternatively, the temperature gauges can be provided at the skin facing the external surface of the multilayer sheet (i.e. the external surface of innermost softer layer).
  • the heating means are electrical resistance heating wires and/or infrared heating means.
  • the garment may be equipped with electrical heating wires or infrared heating means or a combination of both.
  • the infrared heating means may be tubular infrared heating elements.
  • the heating means are preferably distributed throughout the multi-component sheet.
  • other suitable heating means such as chemical heating elements, or channels in which a heating liquid circulates, may be provided.
  • the garment comprises one or more pressure gauges for measuring a pressure level at the inner side of the multi- component sheet and a controller to which the one or more pressure gauges are connected.
  • the garment is preferably equipped with one or several pressure gauges, possibly electrically connected to a controller, for measuring the static (or mean) compression when the sheet is wrapped around a body portion.
  • a pressure gauge is preferably provided at the inner side of the multi-component sheet, and certainly internally relative to the rigid layer.
  • the pressure gauge can be provided at the skin facing the external surface of the multilayer sheet (i.e. the external surface of the innermost layer, being a softer layer).
  • the pressure gauge can be provided within the softer layers, in a composition of the multi-component sheet containing multiple softer layers.
  • the controller may be equipped with a pressure level indicator, such as a readout screen, an indicator lamp or an acoustic signaling means and be configured to determine and indicate when a desired pressure level is attained.
  • the desired pressure level can be expressed either as a minimal value, or as a range within which the static (or mean) pressure should fall. When pressure falls out of the range, i.e. is either too low or too high, controller may provide an indication.
  • the static (or mean) pressure exerted by the garment on the body portion (skin surface) preferably falls in the range between 10 and 60 mm Hg.
  • the desired pressure can be patient-specific as well as body-portion-specific.
  • an indication of the applied pressure can be achieved by applying markings, e.g.
  • the garment comprises a pressure control means for setting a compressive pressure at the inner side of said multi- component sheet.
  • the garment can comprise a pressure control means for maintaining a suitable static (or mean) compressive pressure at the skin surface during lymphedema resorption.
  • the pressure control means may comprise one or more bladders arranged at the inner side of the rigid layer, and preferably interposed between the outer rigid layer and the inner softer layer. One bladder may be provided which extends throughout the sheet. Alternatively, a plurality of smaller, possibly interconnected bladders arranged adjacent to one another may be provided.
  • the pressure control means may further comprise a preferably portable fluid reservoir and a preferably portable pump in fluid connection with the bladder.
  • Figure 1 shows a possible design of a garment (100) according to embodiments of the present invention, applied to a leg (101 ) of a patient.
  • Figure 2 depicts a possible design of a garment (200) according to embodiments of the present invention, applied to an arm (201 ) of a patient.
  • body portion Around the body portion (101 , 201 ) affected with lymphedema, a multi-component sheet (102, 202) is wrapped.
  • the garment (100, 200) comprises fastening means, comprising a fastening strap (103, 203) attached at one edge of the sheet (102, 202) and a ring (104, 204) attached to the opposite edge of the sheet (102, 202).
  • the ring (104, 204) has an aperture capable of receiving a free end of a fastening strap (103, 203) through it, when the sheet (102, 202) is wrapped.
  • Suitable pads (105, 205) made of a hook and loop material may be attached on the fastening strap (103, 203) and possibly on the sheet (102, 202) for securing the free end of the fastening strap (103, 203) to the sheet (102, 202) upon tightening the fastening strap (103, 203) through the ring (104, 204). It will be convenient to note that the fastening straps (103, 203) and the hook and loop pads (105, 205) may be replaced by any other suitable fastening means, such as clasps.
  • An advantage of fastening straps (103, 203) is that they allow for wrapping body portions which are sized within a considerable size range.
  • the multi-component sheet (102, 202) is composed out of two layers, being a rigid layer (106, 206) situated on the outer side of the multi- component sheet (102, 202) and a softer layer (107, 207) situated on the inner side of the multi-component sheet (102, 202) (i.e. the side facing the skin of the treated body portion (101 , 201 )).
  • the rigid layer (106, 206) is the layer on which the fastening means are attached.
  • Heating means such as electrical resistance heating wires (108, 208) are interposed between the outer rigid layer (106, 206) and inner softer layer (107, 207).
  • the heating means (108, 208) are distributed throughout the multi-component sheet (102, 202).
  • the heating means (108, 208) are connected to a controller (109, 209) by an electrical cable (1 10, 210). Heating means (108, 208) and controller (109, 209) are part of
  • a temperature control system comprising a, possibly portable, (electrical) energy source, such as a battery (not shown on Figures 1 and 2).
  • a temperature gauge such as a thermocouple (1 1 1 , 21 1 ) and a pressure gauge (1 12, 212) are electrically connected to the controller (109, 209). Both temperature gauge (1 1 1 , 21 1 ) and pressure gauge (1 12, 212) are situated between the outer rigid layer (106, 206) and the inner softer layer (107,
  • the temperature and pressure levels measured by the temperature gauge (1 1 1 , 21 1 ) and pressure gauge (1 12, 212) are displayed on a readout screen (1 13, 213) of the controller (109, 209).
  • the controller (109, 209) also possesses a control knob (1 14, 214) for setting the temperature level the heating means (108, 208) have to provide.
  • the set temperature is displayed on the
  • the controller can be configured to monitor if the measured static (or mean) pressure exceeds a desired minimal pressure value and/or if the measured static (or mean) pressure is situated between an indicated pressure range. When the pressure is either too low or too high, the controller may provide an indication, e.g., an indicator lamp (not shown on Figures 1 and 2) may light up.
  • an indicator lamp not shown on Figures 1 and 2
  • a suitable compressive pressure at the skin surface during lymphedema resorption may be attained by a pressure control means (not shown on Figures 1 and 2), which can comprise one or more bladders, preferably
  • the garments (100, 200), as shown in Figures 1 and 2, are designed to be portable by a patient, maintaining the range of motion of a patient wearing such a garment (100, 200) on a body portion (101 , 201 ). For the sake
  • the controller (109, 209) can be placed in a housing (not shown on Figures 1 and 2) which is attached, either permanently or removably, to the multi-component sheet (102, 202).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

La présente invention concerne un procédé de traitement d'un lymphoedème et un dispositif pour mettre en œuvre le procédé. Le procédé de traitement d'un lymphoedème, à des fins thérapeutiques et/ou cosmétiques, comprend l'application de chaleur et de pression de compression sur une partie du corps de l'anatomie d'un être-vivant sur le point d'être traité. La partie du corps est chauffée afin d'obtenir une température au niveau de la surface de la peau de la partie du corps dépassant la température normale de la peau, la température ne dépassant pas 40 °C, de préférence ne dépassant pas 39,5 °C. Simultanément et/ou séquentiellement, une pression de compression est appliquée sur la surface de la peau de la partie du corps. La pression de compression est le résultat d'une pression circonférentielle appliquée à l'extérieur, et d'une pression interne, la pression interne étant exercée au niveau de la surface de la peau par les pulsations artérielles et/ou une action musculaire de la partie du corps.
PCT/EP2014/074593 2014-11-14 2014-11-14 Procédé et dispositif pour le traitement d'un lymphoedème Ceased WO2016074740A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2014/074593 WO2016074740A1 (fr) 2014-11-14 2014-11-14 Procédé et dispositif pour le traitement d'un lymphoedème

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2014/074593 WO2016074740A1 (fr) 2014-11-14 2014-11-14 Procédé et dispositif pour le traitement d'un lymphoedème

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WO2016074740A1 true WO2016074740A1 (fr) 2016-05-19

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114533381A (zh) * 2022-02-25 2022-05-27 芜湖市第二人民医院 一种护理用冷敷装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4335726A (en) * 1980-07-11 1982-06-22 The Kendall Company Therapeutic device with temperature and pressure control
WO1998025568A1 (fr) 1996-12-13 1998-06-18 Koninklijke Philips Electronics N.V. Dispositif pour masser des parties du corps
WO2002019954A2 (fr) 2000-09-06 2002-03-14 Diana, Richard Gaine ou enveloppe avec poche de fluide et utilisation de celle-ci pour un drainage lymphatique
US6375674B1 (en) * 1999-01-04 2002-04-23 Medivance, Inc. Cooling/heating pad and system
US20130030331A1 (en) * 2011-07-27 2013-01-31 Tony Quisenberry Method and system for application of thermal therapy relative to the treatment of deep-vein thrombosis and lymphedema
US20130253383A1 (en) 2008-07-10 2013-09-26 Maldonado Medical Llc Gradient sequential thermal compression therapy apparatus and system
US20140276253A1 (en) * 2013-03-13 2014-09-18 Christopher M. Varga Compressive patient warming device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4335726A (en) * 1980-07-11 1982-06-22 The Kendall Company Therapeutic device with temperature and pressure control
WO1998025568A1 (fr) 1996-12-13 1998-06-18 Koninklijke Philips Electronics N.V. Dispositif pour masser des parties du corps
US6375674B1 (en) * 1999-01-04 2002-04-23 Medivance, Inc. Cooling/heating pad and system
WO2002019954A2 (fr) 2000-09-06 2002-03-14 Diana, Richard Gaine ou enveloppe avec poche de fluide et utilisation de celle-ci pour un drainage lymphatique
US20130253383A1 (en) 2008-07-10 2013-09-26 Maldonado Medical Llc Gradient sequential thermal compression therapy apparatus and system
US20130030331A1 (en) * 2011-07-27 2013-01-31 Tony Quisenberry Method and system for application of thermal therapy relative to the treatment of deep-vein thrombosis and lymphedema
US20140276253A1 (en) * 2013-03-13 2014-09-18 Christopher M. Varga Compressive patient warming device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114533381A (zh) * 2022-02-25 2022-05-27 芜湖市第二人民医院 一种护理用冷敷装置
CN114533381B (zh) * 2022-02-25 2023-07-07 芜湖市第二人民医院 一种护理用冷敷装置

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