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
  • A61F13/085—Openable readjustable
• • 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
  • A61F13/01—Non-adhesive bandages or dressings
  • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
  • A61F13/01038—Flexibility, stretchability or elasticity
• • 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
  • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
  • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
  • A61F5/0102—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
  • A61F5/0104—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
  • A61F5/0106—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the knees
  • A61F5/0109—Sleeve-like structures

Definitions

• WO 01 /72250 (Bennet et al; NEOPRESS) discloses an elastic compression support for supporting a wound dressing around the lower leg and foot of a patient, the support comprising a panel and a line of fastenings for drawing together two long edges of the panel where the fastenings comprise mutually aligned pairs of tapes secured to or tabs integral with the panel along its edges arranged so that drawing the tape or tabs apart in mutually opposite directions causes the panel to be tightened in
• compression devices described herein, in particular sleeves thereof, are particularly suited for covering a portion of a limb, a portion of the torso, a portion of the neck, a portion of a head or a portion of a neck and head in combination of a user e.g. for the use in the treatment and/or management of oedema.
• the sleeve may be configured and arranged to cover a limb such that the sleeve extends over at least one major muscle of the limb.
• said at least major muscle may be selected from the following: tibialis anterior, soleus, gastrocnemius, bicep femoris, rectus femoris, vastus medialis, vastus intermedius, vastus lateralis. It will be appreciated the first three listed muscles are major muscles in the lower leg, while the latter five are major muscles in the upper leg (the last four forming the muscle group called quadriceps femoris).
• Releasable closure systems may include zippers, e.g. wherein the first lateral edge of the sleeve may be provided with one half of said zipper and the second lateral edge is provided with a complementary half of said zipper.
• the term "zipper” as used herein includes mechanical closure devices comprising two zipper-tape halves, each provided teeth or other elements including (e.g. male and/or female) interlocking profiles, which can interlocked together or disengaged from another via the use of a slider to form a closed or opened zipper chain, respectively.
• An example of a toothless zipper includes the closure system marketed by GORE under the trade designation LOCKOUT which includes a slider that interlocks the two double channeled polymer tracks.
• the compression device (100) advantageously encircles the relevant portion of the limb and, in this exemplary embodiment the sleeve (1 ) and in particular the central region (14) of the sleeve will encircle most of the limb.
• tongues may favorably include a stiffener, e.g. in the form of elongate wires, bars, grids, or pads.
• Tongues may include either a single stiffener extending substantially across its width and length or one or more stiffeners extending lengthwise provided in series across the width of the tongue.
• stiffeners may be provided within a fabric pocket which is subsequently attached to the appropriate part(s) of the sleeve or tongue, as the case may be; or alternatively stiffeners may be positioned on the surface of the appropriate part(s) of the sleeve or tongue, as applicable, which are then covered completely with a sheet of fabric that is sewn or laminated onto the respective part(s) of the sleeve or tongue, as applicable.
• elongate stiffener (32) that extends lengthwise between the upper and lower edges of the sleeve is provided in the second lateral side region (15) adjacent to the second lateral edge (10).
• main materials desirably have a difference quotient of tension in transverse direction from 15% elongation to 20% elongation that is shallower than the difference quotient of tension in transverse direction from 20% elongation to 25% elongation.
• the difference quotient of tension in transverse direction from 15% elongation to 20% elongation is equal to or less than 70% of the difference quotient tension in transverse direction from 20% elongation to 25% elongation; in one embodiment equal to or less than 55% of the difference quotient tension in transverse direction from 20% elongation to 25% elongation, in one embodiment equal to or less than 45% of the difference quotient tension in transverse direction from 20% elongation to 25% elongation; in one embodiment equal to or less than 35% of the difference quotient tension in transverse direction from 20% elongation to 25% elongation.
• Main materials in one embodiment show a tension in transverse direction at 30% elongation or at 30% elongation, after a one minute hold, equal to or greater than 10 N per cm width, in one embodiment equal to or greater than 15 N per cm width, in one embodiment equal to or greater than 20 N per cm width, in one embodiment equal to or greater than 25 N per cm width.
• main materials show a tension in transverse direction at 30% elongation or at 30% elongation, after a one minute hold, equal to or less than 55 N per cm width, in one embodiment equal to or less than 50 N per cm width, in one embodiment equal to or less than 45 N per cm width, most particularly equal to or less than 40 N per cm width.
• main material have a recovered elongation in transverse direction equal to or greater than 80 %, in particular equal to or greater than 85%, more particularly equal to or greater than 90%, most particularly equal to or greater than 95%.
• Warp knitted spacer fabrics have been found to be suitable. Warp-knitted spacer fabrics are typically knitted on a rib raschel machine having two needle bars. Examples of suitable warp-knitted spacer fabrics include the spacer fabric marketed by Gehring Textiles Inc., Garden City, NY 1 1530, USA under the trade designation SHR 700/3 D3 D/0 7208810 and the spacer fabric marketed by Muller Textil, 51674 Wiehl, Germany under the trade designation 3 Mesh 5992.
• Compression devices may be configured and arranged such that the area of the central region is at least 40% (in particular at least 45%, more particularly at least 50%) of the total area of the sleeve (when the device is not in use).
• compression devices may be configured and arranged such that at a height corresponding to two-thirds the height of sleeve from the lower edge to the upper edge, the central region of the sleeve extends 40% or more across the sleeve in its transverse direction (when the device is not in use).
• at least 85% (in particular at least 90%, more particularly at least 95%) of the total area of the central region of the sleeve is made of said main material (when the device is not use).
• first and/or second lateral side regions include the same material as the central region, said material having the corresponding properties of a main material
• attachment of an optional tongue and/or stiffeners generally the respective regions will not have the corresponding properties of a main material.
• typically the maximum elongation in the transverse direction under a load of 10 N per cm of the first and/or second lateral side regions of the sleeve will be lower (most often significantly lower approaching and possibly reaching 0% elongation) than the maximum elongation in the transverse direction under a load of 10 N per cm of the central region of the sleeve.
• first and/or second lateral side regions do not comprise main material, but another material or materials, again relative to the device as a whole including the releasable closure system elements and/or other elements provided on the first and/or second lateral side regions, desirably the first and second lateral side regions are not more stretchable in the transverse direction than the central region.
• first lateral side region and the second lateral side region show a maximum elongation in the transverse direction under a load of 10 N per cm that is equal to or less than the maximum elongation in the transverse direction under a load of 10 N per cm in the central region of the sleeve.
• each fastening tab (2) is provided with hook, stem and/or cup-shaped fasteners (25) and the outer major surface at the proximal end portion (22) as well as at the inner tab portion (23) of the fastening tabs has a structure or is provided with a structure (26) that is adapted to be engaged by said tab fasteners.
• each fastening tab (2) is provided with hook, stem and/or cup-shaped fasteners (27) (these second tab fasteners may be identical or different to the first tab fasteners (25)) and the outer surface (3) at the first lateral side region (13) of the sleeve (1 ) has a structure or is provided with a structure (28) that is adapted to be engaged by the second tab fasteners (27).
• the first lateral side region (13) is provided with the relevant engagement structure (28) by laminating an appropriate layer of material onto the relevant region of the sleeve.
• the first lateral side region (13) can be easily trimmed along its outer edge.
• the fastener-engagement material and lamination method is selected so that the properties of the main material dictate the overall properties of the first regional side region. Nonetheless a number of the fastener-engagement materials available on the market are inelastic or essentially inelastic.
• At least a portion of said strap is expandable in at least the transverse direction, said expandable portion comprising a material having elasticity in at least the transverse direction and being configured and arranged, such that when the expandable portion is in its non-expanded state there is exteriorly a loop of material rising outwardly and when, in use under the provision of tension in the transverse direction of the sleeve, the expandable portion expands in the transverse direction and the loop flattens.
• the product of the modulus of elasticity of the loop material times the thickness of the loop material is at least 90% of the product of the modulus of elasticity of said main material times the thickness of the main material, in particular the product of the modulus of elasticity of the loop material times the thickness of the loop material is equal to or greater than the product of the modulus of elasticity of said main material times the thickness of the main material.
• the sleeve in the transverse direction from the first lateral side edge (9) to the second lateral side edge (10) the sleeve comprises a first lateral side region (13), a central region (14) and a second lateral side region (15).
• the second lateral edge region of the sleeve is provided with either a plurality of eyelets (12; only one eyelet is labelled) in series between the upper and lower edges of the sleeve.
• the second lateral edge region (15) also includes a stiffener (32) that is located between the eyelets (12) and the second lateral edge (10).
• the adjacent-lying sleeve material is the main material
• the modulus of elasticity and the of the loop material i.e. the outer-layer-material in the two-layer expandable gusset
• the product of the modulus of elasticity of the material of the loop e.g.
• the outer-layer-material in two-layer gusset embodiments times the thickness of the loop material is favorably at least 90% of the product of the modulus of elasticity of the main material times the thickness of the main material, in particular the product of the modulus of elasticity of the material of the loop times the thickness of the loop material is equal to or greater than the product of the modulus of elasticity of said main material times the thickness of the main material.
• each of fastening tabs (2) is threaded through its opposing eyelet (12), turned back on itself and pulled such the first lateral side edge (9) of the sleeve is drawn towards the eyelets (12) so that the sleeve is tightened about the body part, in particular the limb, of the user, wherein the tab is pulled until the loop of the expandable gusset fully flattens out. Once the loop disappears, the fastening tabs are fastened so that the sleeve (and correspondingly the compression device) is restrained about the body part, in particular the limb, of the user.
• Gussets desirably have in their non-expanded state a width relative to the transverse direction of the sleeve of at least 0.1 cm, more desirably at least 0.5 cm. Gussets desirably have in their non-expanded state a width relative to the transverse direction of the sleeve of at most 4cm, more desirably at most 3 cm. In one embodiment, gussets have in their expanded state at the point where the loop just fully flattens out a width relative to the transverse direction of the sleeve of at least 1 cm.
• the exemplary compression device shown in Figures 8 and 9 is an example of an embodiment where the expandable gusset (1 1 ) is arranged such that when the compression device (100) is in use on the body part, in particular the limb, of the user, the gusset extends along a third axis (G), wherein relative to a projection of the third axis (G) onto said plane (P) containing the central axis (A), the third axis (G) is inclined forming an acute angle ( ⁇ ) relative to the central axis (A).
• the sleeve is made of two individual parts (1 a and 1 b) and that the gusset (1 1 ) comprises an outer layer of material (18) and inner layer of material (19), wherein the inner layer of material is affixed to the inner surface of the outer layer of material and configured and arranged so as to provide a loop (20) of outer-layer-material above the inner layer, and wherein the gusset is then affixed to inner surface (4) of the each of two sleeve parts (1 a, 1 b), thus bridging the two sleeve-parts to provide a complete sleeve with the loop (20) facing outwardly.
• the exemplary compression device shown in Figures 1 1 and 12 is a variant of the exemplary embodiment shown in Figures 8 and 9 and differing in two aspects: The first being that the gusset (1 1 ) is not provided an inset, but rather the outer layer (18) of the gusset (1 1 ) is integral with the adjacent-lying material of the sleeve (1 ), in this particular embodiment with the main material of the sleeve, with the inner layer (19) of the gusset being a separate strip of material affixed to the inner surface (4) of the sleeve.
• the gusset (1 1 ) extends lengthwise such that when the compression device (100) is in use on the body part, in particular on the limb, of the user, the gusset extends along a third axis (G), wherein relative to a projection of the third axis (G) onto said plane (P) containing the central axis (A), the third axis (G) is parallel or essentially parallel to the central axis.
• compression devices described herein may be configured to include other structural elements, for example a foot portion extending from the sleeve, in particular extending from an appropriate portion of the lower edge of the sleeve.
• a foot portion may be configured and arranged in the form of a stir-up or alternatively such as foot portion may be configured to provide a more extensive covering of the foot.
• the sleeve and such a foot portion may be configured and arranged so as to provide a boot-like compression device, either closed or opened toed and/or either closed or opened heeled.
• gauge length was set at 70 mm (see 9.2.1 .1 );
• test specimens were three (specimens were die-cut with a die having a
• M2 Warp knitted spacer marketed by Mijller Textil, 51674 Wiehl, Germany under the trade designation 3 Mesh 5992 having the following characteristics:
• the yarn diameter is approximately 400 ⁇ with single filaments having diameters in the range of about 10 ⁇ to about 22 ⁇ , the majority in the range of about 16 ⁇ to about 19 ⁇ and for the other side (side 2) the yarn diameter is approximately 250 ⁇ with single filaments of irregular shape having diameters in the range of about 10 ⁇ to about 22 ⁇ , the majority in the range of about 16 ⁇ to about 19 ⁇ ; and
• CM3 Fabric used in the wrist-splint product marketed by 3M Futuro under the trade designation Reversible Splint Wrist ("Handgelenkschiene” product number 47855).
• the polyester fabrics RP-M-767 and RF-M-2877 are manufactured by Green Textiles, Spartanburg, SC 29301 -4929, USA.
• the artificial leg was first covered with a 35 cm long piece of white knitted polyester stockinet (3M Stockinet 7.6 cm x 22.8 m (MS03; 70-2004-7301 -8)) to facilitate uniform expansion and contraction of the bladder during expansion and evacuation.
• the inflatable bladder was evacuated and empty, and the compression device to be tested was applied to the artificial leg and was then closed and tightened, such that a pressure of approximately 42 mmHg (+/- 3 mmHg) was achieved (as measured with the Pico Press device). The exact pressure was reported and designated as "pressure at rest”.
• the artificial leg was positioned such that its own weight did not influence the pressure distribution at the locations of interest (i.e. for instance upright position and not laying). Standing pressure
• CS3 Reference compression device according to prototype design shown in Figures 13 and 14 and described below using material CM3 as main material.
• Sleeve (1 in Figures 13 and 14) was made of material M1 or CM3, as described above.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Nursing (AREA)
• Orthopedics, Nursing, And Contraception (AREA)
• Professional, Industrial, Or Sporting Protective Garments (AREA)
• Structures Of Non-Positive Displacement Pumps (AREA)

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Cited By (9)

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Citations (10)

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• 2013
  • 2013-03-27 GB GBGB1305545.4A patent/GB201305545D0/en not_active Ceased
• 2014
  • 2014-03-19 EP EP14725827.1A patent/EP2978395B1/en active Active
  • 2014-03-19 AU AU2014241717A patent/AU2014241717B2/en not_active Ceased
  • 2014-03-19 JP JP2016505497A patent/JP6495889B2/ja active Active
  • 2014-03-19 WO PCT/US2014/031220 patent/WO2014160572A1/en not_active Ceased
  • 2014-03-19 CN CN201480030369.5A patent/CN105263451B/zh active Active
  • 2014-03-19 US US14/780,050 patent/US10058457B2/en active Active
  • 2014-03-19 CA CA2908269A patent/CA2908269A1/en not_active Abandoned
• 2018
  • 2018-08-20 US US16/105,019 patent/US11007087B2/en active Active

Patent Citations (11)

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