WO2008006227A1 - Vêtement médical compressif et procédé servant à évaluer un vêtement médical compressif - Google Patents

Vêtement médical compressif et procédé servant à évaluer un vêtement médical compressif Download PDF

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Publication number
WO2008006227A1
WO2008006227A1 PCT/CH2006/000365 CH2006000365W WO2008006227A1 WO 2008006227 A1 WO2008006227 A1 WO 2008006227A1 CH 2006000365 W CH2006000365 W CH 2006000365W WO 2008006227 A1 WO2008006227 A1 WO 2008006227A1
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WO
WIPO (PCT)
Prior art keywords
garment
marks
medical compression
compression garment
medical
Prior art date
Application number
PCT/CH2006/000365
Other languages
English (en)
Inventor
Stefan Ganzoni
Alain Bertheas
Robert Austernaud
Hervé Scelles
Florence Mathieu
Original Assignee
Ganzoni Management Ag
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 Ganzoni Management Ag filed Critical Ganzoni Management Ag
Priority to PCT/CH2006/000365 priority Critical patent/WO2008006227A1/fr
Publication of WO2008006227A1 publication Critical patent/WO2008006227A1/fr

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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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/06—Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/08—Elastic stockings; for contracting aneurisms

Definitions

  • the present invention relates to a medical compression garment having means for measuring compression and a method for evaluating such a medical compression garments.
  • Medical compression garments abbreviated by
  • MCG are garments which are mainly made of elastic knitted fabric. Their aim is to provide a pressure or compressive force, respectively, to a human skin, especially to a limb such as an arm or a leg, for e.g. the treatment of venous diseases and lymphatic disorders.
  • Medical compression garments can for example be used to compress a leg bellow a knee, and entire leg, an arm, a hand and so on.
  • the medical compression garment can be designed in the form of stockings, socks, panties, sleeves, gloves, etc.
  • the medical prescription of a medical compression garment is formulated as a level of compression, expressed in the units hPa or mm/Hg to be applied to a certain area of a limb, for example an ankle area.
  • a medical compression garment may be designed to provide a graded compression from a distal area to a proximal area.
  • the rate of graduation may differ from country to county according to national standards or norms, e.g. for Germany the norm GZG RAL 387 requires that the pressure at a calf area is about 70 % of the pressure at an ankle area, and the pressure at a thigh area is around 70 % of the pressure at the ankle area.
  • the efficiency of a medical compression garment does often not only depend on the prescribed level of pressure at a certain limb area, for example the ankle, but also a certain pressure graduation has to be ensured. If a medical compression garment is donned the wrong way around the graduation is reversed across the limb and this may cause counterproductive physiological effects.
  • the norms provide technical specifications for the level of compression and the rate of graduation of a medical compression garment. It has to be verified that a manufactured medical compression garment meets the technical specifications. This can only be assured if a medical compression garment is properly donned on a leg.
  • the patent application GB 2 322 556 A dis- closes graded compression anti-thrombosis stockings which allow easy identification of the pressure they generate on the patients leg.
  • a form of marker is incorporated into the stocking to assess the amount of stretch. The pressure profile of the stocking can then be assessed on individual patients to maximise the sufficiency of the garment.
  • the marks are supplied along the length of the stocking. Several types of marks are used.
  • the marks can be in the form of continuous or several separate coloured stripes of a pre-determined width marking the stocking along its lengths . Stretching of the fabric will increase the width of the stripes. The more the fabric is stretched, the wider the stripes will appear. An estimation of the pressure profile can then be made by expecting the width of the stripes.
  • the marks can also be in the form of a coloured pattern (e.g. coloured spots with a regular distance apart) which can be incorporated into the fabric along the length of the stocking. The amount of stretch can be identified as the distance between spots increases.
  • electronic or pneumatic pressure sensitive material can be incorporated into the stocking and the pressure profile identified by electronic means .
  • a medical compression garment which is designed such that it allows for easy assessment of the garment being donned correctly or incorrectly on a limb.
  • a limb can be an artificial limb being used for testing purposes in a production facility or a human limb.
  • a method for evaluating a medical compression garment donned on such a limb is provided, that comprises marks which are spaced at inter- vals and are arranged on a surface line of a garment, wherein each of said marks consists of at least three elements.
  • a surface line is also called generator line or generatrix and is e.g. for a medical compression stocking given by a vertical line.
  • the stitches of a fabric used for a medical compression garment which are placed in the same column usually constitute such a surface or generator line.
  • the marks can be spaced at intervals of equal or unequal distance.
  • the elements are preferably positioned such that they span a plane, i.e. the vectors from one element to another element span a plane, in particular they are arranged in a triangle. They each can comprise a dot, a dash, a line or a similar object.
  • the medical compression garment is designed such that it fits over a joint, having a first section above the joint and a second section below the joint.
  • the first section comprises at least one mark and the second section comprises at lease one mark.
  • the first section comprises two marks and the second section also comprises two marks.
  • the marks may be temporary or permanent marks.
  • the marks are preferably formed by knitting, printing and/or sewing. For a printing procedure a stamp or an ink jet may be used.
  • the marks are defined to have a different state than the rest of the medical compression garment. This different state can be visible through direct optical inspection (for example by the human eye) or through indirect optical inspection (for example by appliance of additional special lighting, magnetic fields, measuring of a different resistive, capacitive or inductive behaviour, detection of a different material density, and so on) .
  • direct optical inspection for example by the human eye
  • indirect optical inspection for example by appliance of additional special lighting, magnetic fields, measuring of a different resistive, capacitive or inductive behaviour, detection of a different material density, and so on
  • templates, special lighting, impedance sensors, capacity sensors, photo and image processing techniques, etc. can be applied.
  • the marks are designed such that they have an aesthetic appearance.
  • the marks may be made from the same material as the rest of the medical compression garment. Alterna- tively or additionally, the marks may be made of a material that differs from the material used for the rest of the medical compression garment. For example, to build a mark a short yarn of a different colour or a different polymer yarn can be knotted together with the rest of the medical compression stocking. Also, a conductive or semi- conductive yarn can be plaited together with the rest of the medical compression garment.
  • the means for measuring compression may comprise a transparent template which can be used for assessing the longitudinal and/or the lateral/ circumferential elongation of a mark, when donned on a limb. Such a template is easy to use and cheap in production.
  • a method for evaluating a medical compression garment comprises the steps of donning the medical compression garment on a limb, determining the circumferential extension, the longitudinal extension, and the twist distortion of the garment, and comparing the determined circumferential extension, the determined longitudinal extension, and the " determined twist restortion to a pre-defined circumferential extension, a pre-defined longitudinal extension and a pre- defined twist distortion.
  • the twist distortion the alignment of the marks on a surface line on the garment may be evaluated.
  • the positioning of the elements of a mark may be evaluated.
  • a transparent template may be used for determining the circumferential and/or longitudinal extension.
  • the lateral/ circumferential extension, the longitudinal extension and the twist distortion is also called 3-D material extension as three parameters are concerned.
  • the method comprises the further step of checking the material density distribution, wherein the number of marks of a part of the garment is compared to a pre-defined number depending on the particular part of the garment that is being checked. By checking the number of marks for several parts of the garment it can be checked, if the garment meets the pressure graduation requirements imposed by a norm or a standard.
  • Fig. 2 illustrates schematically the deformation of a medical compression garment donned on a limb
  • Fig. 3 shows schematically the enlargement of a part of a donned medical compression garment compared to the same part of a non-donned compression garment
  • Fig. 4 is a graph showing the force exerted by a medical compression garment as a function of its elongation
  • Fig. 5 shows an equivalent mechanical model of the stitch pattern displayed in Figure 1
  • Fig. 6 shows an elementary cell of the equivalent mechanical model of figure 5
  • Fig. 7 shows the equivalent mechanical model when the mechanical compression garment is not donned correctly
  • Fig. 8 shows an elementary cell of the equivalent mechanical model of Figure 7
  • Fig. 9 shows a medical compression garment according to the invention.
  • Fig. 10 shows a template for checking the longitudinal and the circumferential elongation after the medical compression garment had been donned, and
  • FIG. 11 shows an example of a mark of a medical compression garment.
  • Figure 1 shows an elastic knitted fabric part which is typically used for a medical compression garment. So called inlaid yarns 1 are combined with so- called loop yarns 2. The compression is mainly provided by the extension of the inlaid yarns 1. The degree of extension is determined by the difference between the dimensions of the medical compression garment in a flat, unextended state and the dimensions of the limb, for example a leg, the medical compression garment shall be donned on.
  • the flat dimensions of the medical compression garment are the dimensions of the material without the application of any external mechanical excitation except for the forces of gravity which are usually negligible in the conditions of use.
  • Figure 2 shows schematically the elongations and distortions caused to the medical compression garment when donned on a limb.
  • a Cartesian coordinate system is used as reference coordinate system.
  • Z denotes the longitudinal direction and X, Y denote the lateral or circumferential directions.
  • a vertically arranged number of stitches, i.e. a column of stitches, constitutes a so called surface line or generator line 4 of the medical compression garment.
  • the elongation ⁇ Z in the direction of Z is caused by the difference of the flat longitudinal dimensions of the material and the length of the limb.
  • the twist distortion ⁇ 2 is caused by twisting a part of the medical compression garment in comparison to another part of the medical compression garment, i.e. the medical compression garment is not correctly donned. Of- ten the upper part of medical compression garment is twisted in comparison to the lower part of the garment.
  • Figure 3 shows a part 5 of the medical compression garment or its fabric, respectively, in its flat, unextended state, i.e. having flat dimensions. Part 5 in its flat state is defined by four points A, B, C, and D, having the following coordinates:
  • D 1 (X D . , Y 0 -, Z D .) .
  • the point A' corresponds to the point A, the point B 1 to the point B, the point C to the point C and the point D 1 to the point D.
  • the extension follows from the displacement of the points of the material.
  • the circumferential displacement is denoted as ⁇ cl-
  • the circumferential displacement is denoted as ⁇ Q2 • ⁇ n
  • the longitudinal displacement is denoted as ⁇ j j ⁇ .
  • the longitudinal displacement is denoted as z C2r ⁇ Ll' ⁇ L2 are displacements preferably expressed in percentage [%] between the final dimensions over/relative to the initial dimensions.
  • the extended material of the medical compres- sion garment wraps around a portion of the limb which has a local limb radius R.
  • the percentage of circumferential elongation ( ⁇ c ) is defined by the ratio j
  • Figure 4 depicts a graph that shows the relationship between the force exerted by a medical compression garment and the elongation of the material of the medical compression garment.
  • the vertical axis of the graph indicates the force in cN per cm and the horizontal axis indicates the circumferential elongation ⁇ expressed as percentage.
  • Figure 4 displays three curves with respect to three different longitudinal elongations ⁇ - ⁇ . In a donned state, the distance between two inlaid yarns 1 (see Figures 1 and 2) is denoted ⁇ Z .
  • the density of the inlaid yarns is inversely proportional to the distance ⁇ Z .
  • the elongation ⁇ Z increases from the highest, dashed curve to the lowest drawn though curve. According to Laplace's law the pressure exerted by a part of a medical compression garment onto the surface of a limb is defined as
  • the functions depicted in Figure 4 are not purely linear functions. Some zones of the curves are considered to be more optimal for the provision of adequate medical compression combined with wear comfort than other zones .
  • the zone most apt for the provision of medical compression combined with wear comfort is the func- tional zone 7 that constitutes one of the most linear parts of the curve.
  • the behaviour of the elastic material can be less forward approximated by en equation, especially by a linear equation.
  • restor- ing forces are mainly due to fibre friction and less due to the elasticity of the spandex polymer.
  • the garment becomes uncomfortable to wear due to high forces and a high percentage of elongation (discomfort zone 9) .
  • Each of the curves depicted in Figure 4 can be approximated by a fifth degree polynomial equation of the following form:
  • the shape of the curves in the discomfort zone 9 relates to a plastic behaviour as opposed to an elastic behaviour of the material. This part of the curves can be described by the following exponential equation:
  • This functional zone 7 has at least two parameters, the circumferential extention EQ and the longitudinal extension ⁇ .
  • twist distortion may occur and is therefore considered to form a third parameter.
  • a medical compression garment is donned correctly on a limb - independently of its size -, the geometrical configuration of the knitting pattern has to remain the same, i.e. for a garment in form of a stocking the stitch columns should still constitute straight vertical lines which run in parallel to the Z-axis and the stitch rows should still constitute horizontal straight lines which run in parallel to the X,Y-axes (confer Figures 1 and 2) . If any twisting of the medical compression garment occurs during the donning process, this would lead to a material distortion in form of an angular rotation of the material around the Z-axis (confer Figure 2) .
  • Figure 5 depicts an equivalent mechanical model 10 for a part of a correctly donned medical com- pression garment defined by the points A 1 , B 1 , C and D'.
  • the inlaid yarns are represented by longitudinal strong strings, i.e. springs with a high spring constant, and the loop yarns are represented by vertical light springs, i.e. springs with a low spring constant (confer Figure 1) .
  • the elastic properties of the material can be modelled by using Young' s modulus in combination with Hook' s law to arrive at the equations given with reference to Figure 4.
  • the links between the different kinds of springs have each six degrees of freedom, namely three translations in the directions of the X-axis, the Y-axis and the Z-axis and three rotations around the X-axis, the Y-axis and the Z- axis.
  • These six degrees of freedom are schematically de- picted for one link, also called an elementary cell, in Figure 6. Due to them an angular twist might occur during the donning procedure of the medical compression garment.
  • the depicted part still has a rectangular shape as had the corresponding relaxed part in the flat, undonned state.
  • Figure 7 shows the same equivalent mechanical model 10 as Figure 5 but with a twist distortion due to incorrect donning.
  • the originally rectangular part of the medical compression garment has adopted a lozenge shape defined by the points A' 1 , B'', C' 1 , D''.
  • the twist distortion causes some additional non-predictable elongation of the strong springs and of the light springs .
  • Figure 8 shows a link as defined above.
  • Such ⁇ a link is also called elementary cell.
  • the angles ⁇ ] _ and ⁇ 2 represent the angular material distortions .
  • the cosine of ⁇ j_ with i being equal to 1 or 2 is always smaller than 1, the resulting level of compression due to the twist distortion becomes higher than expected and prescribed.
  • a predefined circumferential extension ⁇ Q has to be met
  • a predefined longitudinal extension ⁇ j j has to be met and there should be no angular distortion ⁇ g, that is a predefined twist distortion of zero degrees has to be met.
  • Figure 9 displays a medical compression garment 11 according to the invention.
  • the medical compression garment 11 has the form of tights or stockings.
  • the medical compression garment 11 comprises a set of marks 12 spaced at intervals and arranged on a surface line 13 of the medical compression garment.
  • the surface line 13 may also be referred to as generator line or generatrix.
  • the medical compression garment 11 is preferably designed such that it contains a first section 14 above a joint 15 of a human body, e.g. a knee, and a second section 16 below such a joint 15.
  • the first section 14 can reach from the knee to the calf and the second section 16 can reach from the sole to the knee in case of a medical compression garment 11 in the form of a medical compression stocking.
  • the first section 14 comprises M marks 12 and the second section 16 comprises N marks 12.
  • the numbers M, N are at least equal to 1, preferably larger than 1.
  • the numbers N and M can be equal or different from each other. In a most preferred embodiment M is equal to N, both numbers being equal to 2.
  • SL and EQ several marks 12 are arranged on a surface line 13.
  • the marks 12 are aligned in the longitudinal direction on the surface line 13.
  • Each mark consists of at least three elements 17 which may be formed as dots.
  • the elements 17 may be connected by connecting elements 18 that can be formed as lines.
  • the elements 17 are preferably arranged such that they span a plane, i.e. the vectors from one element to another element span a plane.
  • the marks 12 are created during the manufacturing process of the medical compression garment 11. The creation can be done at any step of the manufacturing process, even during packaging of the medical compression garment 11 for example by a printing process (jet ink, stamp, etc . ) .
  • the donned configuration of the marks 12 is a so called homothety of the configuration of the marks 12 in a relaxed or flat state of the medical compression garment 11.
  • the minimum of three marks 12 is due to the mathematical definition of any surface or part of the material of the medical compression garment 11 by at least three points, the corresponding equation being:
  • x, y are variables in the lateral/circumferential direction and z is a variable in the longitudinal direction (confer Figure 3) .
  • the distance A 1 B' is an indicator for the circumferential extension E Q and the distance IIA'CII is an indicator for the longitudinal extension ⁇ .
  • the angle formed by the vector C A' and the vertical or longitudi- nal axis is an indicator for the degree of angular or twist distortion. If the value for A 1 C is small, the position of the twist angle ⁇ z is poor as it is derived from A 1 C . In order to compensate for this, several marks 12 are preferably arranged on a generator or surface line 13 of the medical compression garment 11.
  • the local extensions ⁇ Q , EL and the local twist distortion ⁇ z can be evaluated and controlled but also the global extensions EQ, ⁇ and the global twist distortion ⁇ g can be determined with a higher precision, for example, by evaluating the posi- tioning of the elements 17 as the distance between the elements 17 of two different marks 12 is larger than the distance between the elements 17 within one mark 12.
  • a twist distortion ⁇ g can be easily detected by checking the alignment along a given generator -or sur- face line 13 of the limb.
  • the circumferential and longitudinal extensions S Q , ⁇ jj can, for example, be checked by using a transparent template 19 as depicted in Figure 10.
  • the template 19 has a corre- sponding geometrical drawing 20 (for example a circle, a square, a rectangular, or the like) .
  • the geometrical drawing 20 is slightly larger in diameter than an element 17.
  • the geometrical drawings 20 are arranged towards each other.
  • the template 19 can of course comprise geometrical drawings 20 for a group of marks 12, all being arranged on a surface line 13.
  • the checking of the marks 12 with the template 19 can first be conducted on significant areas of the limb or of the medical compression garment 12, respectively, such as an ankle or a calf in case of a leg and a medical compression stocking.
  • Figure 11 shows a different design for a mark
  • the mark 21 of a medical . compression stocking 11.
  • the mark 21 is basically heart shaped enclosing a butterfly for aes- thetic purposes.
  • the mark 21 has a brim of a certain width 22.
  • the longitudinal extension ⁇ can be determined by measuring the width of the brim 22 on the upper side of the mark 21.
  • the circum- ferential or lateral extension E Q can be established by measuring the width of the brim 22 on a lateral side of the mark 21.
  • a twist distortion ⁇ can be detected by evaluating a twisted change of the shape of the mark 21. When donned correctly the measured lateral/ circumferen- tial and longitudinal extensions should lie within predefined tolerances.

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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)
  • Socks And Pantyhose (AREA)

Abstract

La présente invention concerne un vêtement médical compressif ayant des moyens servant à mesurer la compression (12, 13, 19), lequel comprend des marques (12) régulièrement espacées et disposées sur une ligne de surface (13) du vêtement (11), chacune desdites marques (12) étant constituée d'au moins trois éléments (17). En outre, l'invention concerne un procédé servant à évaluer un tel vêtement médical compressif lequel comprend les étapes consistant à enfiler le vêtement médical compressif (11) sur un membre, déterminer l'allongement circonférentiel (εC), l'allongement longitudinal (εL) et la déformation par torsion (ϑZ) dudit vêtement (11) et comparer l'allongement circonférentiel déterminé (εC), l'allongement longitudinal déterminé (εL) et la déformation par torsion (ϑZ) déterminée à un allongement circonférentiel prédéfini, un allongement longitudinal prédéfini et une déformation par torsion prédéfinie. L'invention peut être utilisée pour vérifier si un vêtement médical compressif est enfilé correctement.
PCT/CH2006/000365 2006-07-11 2006-07-11 Vêtement médical compressif et procédé servant à évaluer un vêtement médical compressif WO2008006227A1 (fr)

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PCT/CH2006/000365 WO2008006227A1 (fr) 2006-07-11 2006-07-11 Vêtement médical compressif et procédé servant à évaluer un vêtement médical compressif

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PCT/CH2006/000365 WO2008006227A1 (fr) 2006-07-11 2006-07-11 Vêtement médical compressif et procédé servant à évaluer un vêtement médical compressif

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2929506A1 (fr) * 2008-04-07 2009-10-09 Tournier Bottu Internat Soc Pa Orthese de contention
WO2014014672A1 (fr) 2012-07-19 2014-01-23 3M Innovative Properties Company Détermination d'allongement d'un bandage élastique
WO2023186263A1 (fr) * 2022-03-28 2023-10-05 Essity Hygiene And Health Aktiebolag Vêtement de compression avec indicateur

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3613679A (en) * 1969-10-01 1971-10-19 Patricia W Bijou Elastic bandage with tension indicator
WO1996031175A1 (fr) * 1995-04-01 1996-10-10 Smith & Nephew Plc Article en tissu avec indicateur d'extension
GB2322556A (en) * 1997-03-01 1998-09-02 Anthony Chi Wing Hui Graded compression anti-thrombosis stockings with pressure indication
EP1086675A2 (fr) * 1999-09-25 2001-03-28 Bauerfeind Orthopädie GmbH & Co. KG Manchon de compression pour la contention de la jambe
US6338723B1 (en) * 1998-09-16 2002-01-15 Circaid Medical Produts, Inc. Compression device with compression measuring system
DE102004052749A1 (de) * 2004-10-30 2006-05-04 Werner Dr. Siekmann Stützstrumpf

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3613679A (en) * 1969-10-01 1971-10-19 Patricia W Bijou Elastic bandage with tension indicator
WO1996031175A1 (fr) * 1995-04-01 1996-10-10 Smith & Nephew Plc Article en tissu avec indicateur d'extension
GB2322556A (en) * 1997-03-01 1998-09-02 Anthony Chi Wing Hui Graded compression anti-thrombosis stockings with pressure indication
US6338723B1 (en) * 1998-09-16 2002-01-15 Circaid Medical Produts, Inc. Compression device with compression measuring system
EP1086675A2 (fr) * 1999-09-25 2001-03-28 Bauerfeind Orthopädie GmbH & Co. KG Manchon de compression pour la contention de la jambe
DE102004052749A1 (de) * 2004-10-30 2006-05-04 Werner Dr. Siekmann Stützstrumpf

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2929506A1 (fr) * 2008-04-07 2009-10-09 Tournier Bottu Internat Soc Pa Orthese de contention
WO2009136063A1 (fr) * 2008-04-07 2009-11-12 Tournier Bottu International Orthese de contention
WO2014014672A1 (fr) 2012-07-19 2014-01-23 3M Innovative Properties Company Détermination d'allongement d'un bandage élastique
EP2875325A4 (fr) * 2012-07-19 2016-07-27 3M Innovative Properties Co Détermination d'allongement d'un bandage élastique
US9798930B2 (en) 2012-07-19 2017-10-24 3M Innovative Properties Company Determining elongation of elastic bandage
WO2023186263A1 (fr) * 2022-03-28 2023-10-05 Essity Hygiene And Health Aktiebolag Vêtement de compression avec indicateur

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