WO2019016726A1 - ORTHOPEDIC MEDICAL DEVICE - Google Patents

ORTHOPEDIC MEDICAL DEVICE Download PDF

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Publication number
WO2019016726A1
WO2019016726A1 PCT/IB2018/055338 IB2018055338W WO2019016726A1 WO 2019016726 A1 WO2019016726 A1 WO 2019016726A1 IB 2018055338 W IB2018055338 W IB 2018055338W WO 2019016726 A1 WO2019016726 A1 WO 2019016726A1
Authority
WO
WIPO (PCT)
Prior art keywords
orthopedic
orthesis
layer
medical device
guardian
Prior art date
Application number
PCT/IB2018/055338
Other languages
English (en)
French (fr)
Inventor
Daniele VECCHINI
Original Assignee
Vecchini Daniele
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 Vecchini Daniele filed Critical Vecchini Daniele
Priority to EP18755901.8A priority Critical patent/EP3654793A1/en
Priority to US16/632,604 priority patent/US20200163405A1/en
Publication of WO2019016726A1 publication Critical patent/WO2019016726A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B1/00Footwear characterised by the material
    • A43B1/0081Footwear characterised by the material made at least partially of hook-and-loop type material 
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/1425Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the ball of the foot, i.e. the joint between the first metatarsal and first phalange
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1415Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot
    • A43B7/144Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the location under the foot situated under the heel, i.e. the calcaneus bone
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1455Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form with special properties
    • A43B7/1464Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form with special properties with adjustable pads to allow custom fit
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00Footwear with health or hygienic arrangements
    • A43B7/14Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/1405Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form
    • A43B7/1475Footwear with health or hygienic arrangements with foot-supporting parts with pads or holes on one or more locations, or having an anatomical or curved form characterised by the type of support
    • A43B7/149Pads, e.g. protruding on the foot-facing surface
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43DMACHINES, TOOLS, EQUIPMENT OR METHODS FOR MANUFACTURING OR REPAIRING FOOTWEAR
    • A43D8/00Machines for cutting, ornamenting, marking or otherwise working up shoe part blanks
    • A43D8/02Cutting-out
    • A43D8/04Stamping-out

Definitions

  • the present invention refers, in general, to an orthopedic medical device. More particularly, the present invention refers to an orthopedic medical device for a universal use in fixed or mobile orthopedic guardians as well as in the therapy of foot pathologies.
  • said orthopedic guardians or plantar soles are no more tolerated by the patient or user because the patient or user feels so sharp pains (plantalgies) that are unbearable.
  • the patient or user has to substitute the used orthopedic guardian or plantar sole repeatedly by a new device.
  • An object of the invention is to remove the above-mentioned inconveniences and still others through an orthopedic medical device that ensures a wide possibility of varying, reconstructing or, in any case, modifying the orthesis anatomy of an orthopedic guardian, a medical podotherapic device or the like, also with an immediate or gradual intervention according to the evolution of the therapy in course and without interruptions in the treatment.
  • Another object of the invention is to provide a medical orthopedic device ensuring an optimal adaptability of an orthesis anatomy obtainable also for subsequent approximations, according to the specific requirements of each single case, in decubitus and compression zones causing pain or in zones that need to be isolated and protected.
  • Another object of the invention is to provide a medical orthopedic device that is washable and/or sterilizable and/or replaceable and is capable of ensuring the maintenance of hygienic conditions in each intervention area or otherwise positionable in order to be adapted to a changed condition of the area to be protected.
  • an orthopedic medical device which comprises an orthesis structure which has at least one external wall to be anchored to a face or wall of an orthopedic guardian adapted to directly or indirectly contact an area of a body limb or bodypart to be protected.
  • the orthesis structure comprises, preferably, at least one external wall which is anchored removably to the face of the orthopedic guardian.
  • the at least one external wall comprises a layer of grasping or graspable material which grasps or is grasped to said face of the orthopedic guardian which comprises a graspable or grasping material, respectively.
  • the external wall comprises removable male or female engaging means which cooperate with removable female or male engaging means, respectively, which are provided on the face of the orthopedic guardian.
  • the orthopedic medical device is at least partially configured as an orthesis map with removable zonal islands and ortheses for the formation of anatomical discharges and/or inserts.
  • the orthesis structure comprises a layered structure consisting of at least one supporting layer and at least one diecut layer defined by removable islands or zones.
  • said supporting layer comprises a diecut layer and a covering element in a graspable material, joined to each other.
  • said diecut layer comprises:
  • Said diecut layer and said covering element are jointed to each other in correspondence of the peripheral edge of the hollow punch.
  • the orthesis structure is in a rigid or semi-rigid or elastically yielding material.
  • the layers of grasping material, soft, rigid or semirigid material and covering material are bound or coupled together.
  • Fig. 1 is a plan view of a plantar sole bearing an orthesis element according to the invention
  • Fig. 2 is a side view of the plantar sole in Fig. 1 ;
  • Fig. 3 is a view in section in a slightly enlarged scale taken along the trace in Fig. 1 ;
  • Fig. 4 represents another embodiment of the plantar sole, an orthesis element according to the invention being applied thereon,
  • Fig. 5 is a view in section and in an enlarged scale taken along the trace V- V in Fig. 4;
  • Fig. 6 is a perspective view of an orthesis element to be anchored in a removable way to a plantar sole according to the invention
  • Fig. 7 represents a plan view of another embodiment of an orthesis structure made of an elastically yielding material to be anchored in a removable way to a plantar sole according to the invention
  • Fig. 8 is a view in section taken along the trace VIII-VIII in Fig. 7;
  • Fig. 9 shows another embodiment of a mobile orthesis element made of a semirigid material
  • Fig. 10 represents a view in section taken along he trace X-X in Fig. 9;
  • Fig. 1 1 is a partial plan view of the calcaneal portion of another embodiment of the plantar sole according to the invention.
  • Fig. 12 shows a section taken along the trace XII-XII in Fig. 11 ;
  • Fig. 13 shows a first embodiment of the plantar sole having an orthesis map
  • Fig. 14 is a view in section and in an enlarged scale taken along the trace XIV-XIV in Fig. 13;
  • Figures 15, 16 and 17 shows respective embodiments of plantar soles having an orthesis map
  • Fig. 18 is a partial view in section and in an enlarged view taken along the trace XVIII-XVIII in Fig. 17;
  • Fig. 19 shows another embodiment of a plantar sole having an orthesis plan
  • Fig. 20 is a view in partial section and in enlarged scale taken along the trace XX-XX in Fig. 19;
  • Fig. 21 is a perspective view of a shoe with an internal calcaneal orthesis band according to the invention, provided with one or more corrective buttresses.
  • reference number 1 denotes a plantar sole 1 on the whole which is formed by a support 2 which consists of one or more layers of a suitable material such as cardboard, leather, plastic material, and in case shaped so as to be adapted to the foot anatomy, as is usual in the shoe manufacture, as well as a covering layer 3 which covers at least its face, which is designed to support the foot of the user, the covering layer 3 being formed, for example, by a fabric, a non-woven fabric, or the like, and is glued to the support 2.
  • a support 2 which consists of one or more layers of a suitable material such as cardboard, leather, plastic material, and in case shaped so as to be adapted to the foot anatomy, as is usual in the shoe manufacture, as well as a covering layer 3 which covers at least its face, which is designed to support the foot of the user, the covering layer 3 being formed, for example, by a fabric, a non-woven fabric, or the like, and is glued to the support 2.
  • Each orthesis element or insert consists of one or more layers or bodies or globes of a rigid material (which may be formed by or may include metal elements or metallic alloys, for example copper, aluminum, or ferromagnetic components), or a semi-rigid material such as leather, wood, cork, PVC (polyvinylchloride), polypropylene, polyethylene, polyesther, ETV, EVA (ethylvinylacetate), polyvinylacetate, acrylic materials and soft, elastically yielding materials such as rubber, elastomeric cork-rubber plastic materials, polyethylene sponge, rubber sponge with opened cells and/or microcellular rubber sponge, silicone, felts and the like, and at least one external wall applied thereto so as to be applied removably to the face or wall 3 of the plantar sole 1.
  • a rigid material which may be formed by or may include metal elements or metallic alloys, for example copper, aluminum, or ferromagnetic components
  • a semi-rigid material such as leather, wood, cork, PVC (
  • a plurality of orthesis elements or inserts 4 of different orthesis configuration it is possible to obtain, on a plantar sole, a template or fussbet of whatever shoe (a normal shoe, a sport shoe, an orthopedic shoe), an orthesis configuration which is modifiable according to the need of the user because it is formed by orthesis elements or inserts 4 which are removable and repositionable.
  • Figures 4 to 6 show a flat plantar sole or sole 5 formed by three layers, namely, a cardboard layer 6 acting as a supporting surface for the user foot, an intermediate layer 7 in a plastic material, for example polyurethane foam, and a covering 8 in a grasping material of any suitable type, for example of self-adhesive type to be applied to the lower face of the sole or plantar sole.
  • a cardboard layer 6 acting as a supporting surface for the user foot
  • an intermediate layer 7 in a plastic material for example polyurethane foam
  • a covering 8 in a grasping material of any suitable type, for example of self-adhesive type to be applied to the lower face of the sole or plantar sole.
  • One or more orthesis inserts 9 may be applied to the grasping layer 8, in both the calcaneal zone and the zones of the foot sole and foot toes, so as to form a desired orthesis configuration.
  • each orthesis insert 9 may have a body 10 in elastically yielding material and at least one surface 11 covered by a fabric or other material on which the grasping layer 8 can ensure a secure removable grip.
  • the orthesis inserts 9 are designed to be arranged in correspondence of the face of the plantar sole or sole 5 which, in use, is beneath so that the orthesis inserts 9 are hidden and can not be seen.
  • the orthesis insert 12 of Figure 7 and 8 is typically formed, as the orthesis inserts 4 and 9, by a three-layer structure, namely, an upper covering layer 13 in fabric, non-woven fabric, or the like, an intermediate tridimensional layer 14, for example in elastically yielding material, such as rubber, latex, and the like, and a lower layer 15 in a grasping material, said layers being sewn, in case, together along the border of the orthesis insert.
  • a three-layer structure namely, an upper covering layer 13 in fabric, non-woven fabric, or the like, an intermediate tridimensional layer 14, for example in elastically yielding material, such as rubber, latex, and the like, and a lower layer 15 in a grasping material, said layers being sewn, in case, together along the border of the orthesis insert.
  • the orthesis insert 16 ( Figures 9 and 10) has a parallelepiped configuration and is formed by two layers: for example, on layer in a semirigid or elastically yielding material 14 and the other layer in a gripping material 15.
  • Figures 11 and 12 show an orthesis insert 17 which is configured so as to grasp and interest the whole peripheral band of the calcaneal zone of a plantar sole or sole 17, and has a cross section which is decreasing from the periphery to the inside, as shown in Figure 12.
  • orthesis inserts showing a structure as described above may be used in various sectors in addition to the podiatric sector, the orthopedic sector and the medico-chirurgical sector, also in the aesthetic sector, sport sector, physiotherapy and rehabilitation sector and in the shoe industry in general.
  • orthesis inserts according to the invention may be used, for example in connection with all the problems connected to corns, hyperkeratosis, ingrown nails, and also in all those morbid pathologies and non- morbid pathologies in which it is necessary to modify the posture condition of the foot (valgus or varius heel, twisted or supine or prone forefoot) with corrective effect also of anomalies of the lower limbs as concerns the knee or the femoral rotation, as in the case of a gait with toes turned inwards or outwards, in the case of a varius shinbone, valgus or varius knee or femoral antinversion.
  • map plantar soles or map soles for example as those that are shown in the Figures 13 to 20.
  • a map plantar sole or map sole 20 can be typically that shown in the Figures 13 and 14, in which a multi-layer structure is provided. More precisely, said multi-layer structure comprises a first support layer which, for example, is formed in turn by a leather die-cut 21 and a covering felt layer 22, which are sewn together along the peripheral border of the die-cut or coupled to each other differently, as well as a mapped layer or die-cut layer including three layers, namely a grasping layer 23 tuned toward the covering felt 22 to be fixed to it removably, a layer of soft, rigid or semi-rigid material 24, for example a plastic material, and a covering layer 25, for example a fabric, a felt, and the like.
  • a first support layer which, for example, is formed in turn by a leather die-cut 21 and a covering felt layer 22, which are sewn together along the peripheral border of the die-cut or coupled to each other differently, as well as a mapped layer or die-cut layer including three layers, namely a grasping layer 23
  • the islands “g” to “k” are provided to unload or support the metatarsal heads so as to avoid single or multiple metatarsalgia.
  • the island I In correspondence of the island I (medial arch), it is possible to support or unload the head of the first (g), second (h+m) and third (n+i) metatarsus while in correspondence of the island "o" (lateral forefoot) it is possible to support or unload the third (n+i), the fourth (j) and the fifth (k) metatarsus as well as to correct the effects of the supination and the effects of all the forefoot anomalies that can affect this area of the foot.
  • the island “r” may be corrective, compensative or stimulating for the structure of the plantar arch in all the cases, for example, of abnormal foot, hollow foot and flat foot.
  • the island “r” may be associated to the island “I” for an effective orthesis correction of pathologies of the plantar arch such as yielding, rigidity, hyperextensions and hyperflexions of the first and second ray.
  • the island “s" (central-lateral zone of the medial plantar arch) is the supporting seat of the base of the fifth metatarsus and can be conveniently unloaded and corrected in case of a pathologic foot or a foot affected in this area by morbid or styloid processes.
  • the island “s” may be advantageously associated to the island “o” for an effective correction of the whole middle-lateral foot by applying suitable orthesis inserts according to the invention.
  • the island “t” corresponds to the supporting seat of the calcaneal apophysis and can act as a discharge to the calcaneal spine for the treatment of talalgia or heel inflammations and the various pathologies of the heel, while the islands “u” and “v” correspond to areas of the calcaneal contour and allow through the insertion of suitable orthesis elements to compensate the asymmetries of the lower limbs as well as the abnormalities of support caused by a valgus or varius heel, varius shinbone, etc.
  • the island “p” can act as an unloading area for the medial plantalgia and the supporting seat corresponding to the sinus of the tarsus, or it can be corrected with an orthesis element in case of sprains or dislocations of all the ankle ligaments.
  • the island “p” in association with the island “t” allows, for example, to unload the insertions of the plantar muscles and the aponeurosis in the calcaneal zone.
  • the island “q” is the separation zone between the middle foot and the forefoot and may be utilized together with the islands “I”, “p” and “ , or together with the islands “o” and “s”, as reinforcement seat by means of orthesis medial or lateral inserts or as unloding seat for medial and lateral orthesis correctives.
  • the islands “a” to “e” are unloading zones for a respective foot toe, while the island “f may form an unloading zone or a supporting interdiaphyseal zone for any toe anomaly such as olinodattille, hammertoes, deformed toes.
  • a plantar sole or sole 20 In order to create an unloading zone in a plantar sole or sole 20, it is sufficient to "pull up" (Fig. 15) or remove the corresponding mapping island or remove a portion of layers 24 and 25 from the grasping layer 22, which portion can be, in case, utilized as insert in a neighboring island or elsewhere in the plantar sole or sole.
  • This possibility of transposition of the map island involves that a plantar sole or sole 20 forms a "kit" of orthesis elements at disposal of the operator who can, therefore, intervene rapidly to personalize the plantar sole or sole in order to adapt it to the specific requirements of the anomalies or pathologies of the user.
  • anchoring means of an orthesis insert may be various.
  • said means may include the sewing, the closing by means of metal points, the hole-peg coupling 26 ( Figures 17 and 18) or the coupling with approaching pegs (type Lego®) or through adhesion by magnetic attraction and others, the particular type of anchoring means being not determinant.
  • anchoring means which allow, if necessary, a removal of the orthesis insert so that it can be replaced with another orthesis element or it can be oriented differently.
  • the mapping of the orthopedic medical device can be also of the "geometrical" type, with holes, rhombuses, polygonal windows occupied in case by zones incorporating metal elements 31 ( Figures 17, 18).
  • the removability of the orthesis elements according to the present invention forms a particularly advantageous feature because it makes possible to obtain, in a short time, the optimal orthesis configuration for the single user or patient while the optimal orthesis configuration can be often obtained only with successive approximations of conformation of the inserts and positioning or orienting of the inserts.
  • an orthesis element according to the invention can be applied also to the internal wall of the upper or ankle boot of a shoe so that the orthesis element can, for example, take the configuration of a calcaneal medial or lateral buttress 30 ( Figure 21 ), or can be applied to the internal front wall of ski boots for the protection of the shinbone.
  • orthesis elements according to the present invention can be used in decubitus or compression areas creating pain for the patient, and in any case in points where it is necessary to isolate areas to be protected for a rapid rehabilitation of the injured area.
  • orthesis elements according to the invention can be arranged inside a helmet, for example for one or more head areas affected by lesions or abnormalities.
  • orthesis elements according to the invention can constitute modifications in general of orthopedic braces, prostheses, and orthopedic articles.
  • the thickness and the anatomic-corrective conformation of the various orthesis inserts according to the invention can be the most varied ones according to the specific application to which they are designed.
  • a technician of the sector can provide other modifications or variants which are to be considered as included in the scope of protection of the present invention.
PCT/IB2018/055338 2017-07-19 2018-07-18 ORTHOPEDIC MEDICAL DEVICE WO2019016726A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP18755901.8A EP3654793A1 (en) 2017-07-19 2018-07-18 Orthopedic medical device
US16/632,604 US20200163405A1 (en) 2017-07-19 2018-07-18 Orthopedic medical device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102017000082185A IT201700082185A1 (it) 2017-07-19 2017-07-19 Dispositivo medico ortopedico
IT102017000082185 2017-07-19

Publications (1)

Publication Number Publication Date
WO2019016726A1 true WO2019016726A1 (en) 2019-01-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/055338 WO2019016726A1 (en) 2017-07-19 2018-07-18 ORTHOPEDIC MEDICAL DEVICE

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Country Link
US (1) US20200163405A1 (it)
EP (1) EP3654793A1 (it)
IT (1) IT201700082185A1 (it)
WO (1) WO2019016726A1 (it)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11311075B2 (en) * 2017-12-15 2022-04-26 Chez Nous Brands, Inc. Comfortable dress shoes
US20220151814A1 (en) * 2020-11-18 2022-05-19 Kinetic Orthotics Pty Ltd Orthotics

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4316333A (en) * 1979-11-28 1982-02-23 Featherspring International Corporation Separable fastener for removable foot supports
EP0549539A1 (en) * 1991-12-20 1993-06-30 IL PODOLOGO S.r.l. Kinesiological podoceptor plantar
US6227458B1 (en) * 1993-12-03 2001-05-08 Schering-Plough Healthcare Products, Inc. Deodorizer
EP1321056A1 (en) * 2001-12-21 2003-06-25 HTM SPORT S.p.A. Insole particularly for shoe
WO2006108660A1 (de) * 2005-04-13 2006-10-19 Axel Krauss Vorrichtung und verfahren zum orthopädisc hen zurichten von schuhwerk
WO2008102391A1 (en) * 2007-02-23 2008-08-28 Scm Consulting S.A.S. Inner sole
US20100058540A1 (en) * 2008-09-05 2010-03-11 Nathaniel Calvert Modular hook and loop attachment cushions
WO2013063341A2 (en) * 2011-10-27 2013-05-02 Nike International Ltd. Dual-density insole with a molded geometry
US20140053428A1 (en) * 2012-08-27 2014-02-27 OrthoSole LTD High heel foot wear pad and methods of making and attaching same
WO2017003473A1 (en) * 2015-06-30 2017-01-05 Aurora Enterprises, Llc Modified footwear

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4316333A (en) * 1979-11-28 1982-02-23 Featherspring International Corporation Separable fastener for removable foot supports
EP0549539A1 (en) * 1991-12-20 1993-06-30 IL PODOLOGO S.r.l. Kinesiological podoceptor plantar
US6227458B1 (en) * 1993-12-03 2001-05-08 Schering-Plough Healthcare Products, Inc. Deodorizer
EP1321056A1 (en) * 2001-12-21 2003-06-25 HTM SPORT S.p.A. Insole particularly for shoe
WO2006108660A1 (de) * 2005-04-13 2006-10-19 Axel Krauss Vorrichtung und verfahren zum orthopädisc hen zurichten von schuhwerk
WO2008102391A1 (en) * 2007-02-23 2008-08-28 Scm Consulting S.A.S. Inner sole
US20100058540A1 (en) * 2008-09-05 2010-03-11 Nathaniel Calvert Modular hook and loop attachment cushions
WO2013063341A2 (en) * 2011-10-27 2013-05-02 Nike International Ltd. Dual-density insole with a molded geometry
US20140053428A1 (en) * 2012-08-27 2014-02-27 OrthoSole LTD High heel foot wear pad and methods of making and attaching same
WO2017003473A1 (en) * 2015-06-30 2017-01-05 Aurora Enterprises, Llc Modified footwear

Also Published As

Publication number Publication date
EP3654793A1 (en) 2020-05-27
US20200163405A1 (en) 2020-05-28
IT201700082185A1 (it) 2019-01-19

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