WO2010049417A1 - Dispositif contenant un cathéter, pansement pour cathéter et kit renfermant l'un et l'autre - Google Patents

Dispositif contenant un cathéter, pansement pour cathéter et kit renfermant l'un et l'autre Download PDF

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Publication number
WO2010049417A1
WO2010049417A1 PCT/EP2009/064144 EP2009064144W WO2010049417A1 WO 2010049417 A1 WO2010049417 A1 WO 2010049417A1 EP 2009064144 W EP2009064144 W EP 2009064144W WO 2010049417 A1 WO2010049417 A1 WO 2010049417A1
Authority
WO
WIPO (PCT)
Prior art keywords
silver
slit
aluminium
catheter
dressing
Prior art date
Application number
PCT/EP2009/064144
Other languages
English (en)
Inventor
Gianni Pecorari
Original Assignee
Emodial S.R.L.
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 Emodial S.R.L. filed Critical Emodial S.R.L.
Priority to CA2741926A priority Critical patent/CA2741926C/fr
Publication of WO2010049417A1 publication Critical patent/WO2010049417A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • 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
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00412—Plasters use for use with needles, tubes or catheters
    • 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
    • A61F2013/00361—Plasters
    • A61F2013/00902—Plasters containing means
    • A61F2013/00936—Plasters containing means metal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
    • A61M2025/0273—Holding devices, e.g. on the body using pads, patches, tapes or the like having slits to place the pad around a catheter puncturing site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/002—Packages specially adapted therefor ; catheter kit packages

Definitions

  • the invention relates to the field of medical devices, in particular container devices for containing catheters and dressings for catheters.
  • Catheters are vascular access devices used in the medical field for liquid infusion and intravenous administration of pharmaceutical drugs. In some pathologies these vascular accesses can be kept open for rather long times.
  • central venous catheter is an external vascular access that is tunnelled over a long period of time (for example in oncology and peritoneal dialysis) or for obtaining an immediate access in emergency situations.
  • the central venous catheter is constituted by a variable-length catheter of about 20 centimetres with a diameter of the order of a few millimetres, which is tunnelled below the skin by inserting the terminal part thereof into the path of a central vein (subclavian, jugular, femoral).
  • One or more connections for infusion devices are located In the proximal part of the catheter, external of the skin.
  • the access point must be closed as quickly as possible without getting infected; if not a further implant will have to be made in a different position.
  • the portion of catheter which projects from the body has to be fixed to the body or collected in a pouch which has the function of protecting the catheter from external agents and which can be fixed to the body by a plaster.
  • the medical field uses dressings, the surface layer of which is made of aluminium or in which the fibres of the surface layer are covered with aluminium, in order to facilitate haemostasis and to prevent infection.
  • dressings for example, in a tracheostomy, an operation which creates a permanent opening between the trachea and the cervical skin, dressings are applied in which the fibres of the surface layer are clad with aluminium.
  • these tracheostomy dressings are placed around the zone of the throat adjacent to the tracheostomy tube in order to facilitate cicatrisation.
  • the tracheostomy dressings have a slit which is suitable for surrounding the tube and therefore adhere more satisfactorily as the zone in which the tracheostomy tube projects from the body.
  • the slits consist of a cut terminating in a circular hole of diameter 8-12 mm suitable for locating the tracheostomy dressing in strict adherence to the tracheostomy tube, the external dimensions of which correspond.
  • a length of plaster is used to fix the tracheostomy dressing to the skin a length of plaster is used. Cicatrisation of the wound of the tracheostomy takes a couple of months.
  • the portion of tube which projects from the neck is of a minimal length, so that it does not cause traumas over a long time to the entry zone due to accidental impacts or proximal displacements, and once the wound has cicatrised there is no further need for dressing.
  • the aim of the present invention is to provide a medical device enabling a reduction of the catheter replacements, in particular to provide a container device for a catheter which both contains the portion of catheter external of the body and facilitates the healing and reduces the probability of infection of the wound, both in the post-operative period and during the time the catheter is attached, thus reducing the number of implanting procedures to which a patient has to be subjected.
  • a further aim of the present invention is to provide a catheter dressing which facilitates healing and reduces the probability that the wound will get infected during the post-operative period and during the time the catheter is attached.
  • the invention further has the objective of providing a kit comprising at least a device according to the invention and at least a catheter dressing according to the invention.
  • a system constituted by a catheter container device of a type constituted by a pouch which is accessible from the outside by means of an opening, the pouch being constituted by two facing walls, in which at least one of the walls affords an opening 12 for freely couplingly receiving the catheter contained in the pouch; and a dressing for catheters comprising: at least a surface layer destined to be laid on the skin, the layer being blood-permeable and permeable to bodily fluid; at least an internal absorbent layer; at least an internal absorbent layer; in which at least one from among the surface layer and the internal absorbent layer comprises at least a substance selected from a group consisting of silver, aluminium and derivatives thereof; and at least a slit selected from a group comprising:
  • a fissure-shaped cut starting from an edge of the dressing and terminating with a hole, which single cut is of a length comprised between 0 and 6 cm and which hole is circular with a diameter comprised between 1 .5 mm and 7 mm, preferably between 5-6 cm.
  • the special conformation and dimensions of the slits enable the catheter dressing of the invention to be better adapted to the profile of the catheter at the point in which it emerges from the body, and thus to be placed in contact with the whole zone surrounding the point.
  • the presence of silver or aluminium or derivatives thereof in the catheter dressing facilitates haemostasis and thus both reduces healing times and antibacterial characters, reducing the probability of infection in the wound.
  • the catheter dressing of the invention can be used singly in the post-operative period, or can be applied on the catheter container device such as to be located in contact with the skin when the slit of the device receives the catheter, the slits corresponding to the device and the dressing being superposed.
  • the catheter dressing is applied on the container device at each application and will be periodically replaced during the course of the application of the dressing while the catheter container device can be re- utilised more than once if in good condition and clean.
  • kits comprising at least one of the catheter container devices and at least a catheter dressing as described above of the invention is advantageous.
  • Figure 1 is a perspective view of an embodiment of the invention
  • figure 1 a is an alternative slit to the one shown in the embodiment of the invention of figure 1 ;
  • figure 2 is a perspective view of a further embodiment of the invention.
  • Figure 1 illustrates a catheter container device 10 of the invention.
  • the device 10 is constituted by two walls 13, 13' facing one another and having one of the walls 13' exhibiting a slit 14 destined to freely couplingly receive the catheter contained in the pouch 1 1.
  • Figures 1 and 2 show particular preferred embodiments of the invention in which the walls 13, 13' of the catheter container device have a different extension and define, as shown in figures 1 and 2, a flap 15 adjacent to the opening 12, and in which the slit 14 involves the flap 15.
  • This embodiment is particularly preferred in that it enables application of the catheter dressing 100 of the invention and makes the arrangement of the device 10 about the catheter easier to accomplish.
  • the slit 14 of the catheter container device 10 can originate from:
  • the slit 14 of the catheter container device 10 can preferably originate from a point of the edge portion of the opening 12 relative to the wall 13 or 13'.
  • the slit 14 of the container device 10 destined to receive the catheter in free coupling is advantageously:
  • the slit begins with a first cut 20 and terminates in a bifurcation defined by two further cuts 21 , 21 ' which originate from an end of the first cut 20 and identify and angle 22;
  • the single cut 23 has a length comprised between 0 and 6 cm and the hole is circular with a diameter comprised between 1.5 and 7 mm, in particular comprised between 5 and 6 mm.
  • the conformations enable the area of the device in contact with the skin surrounding the entry point of the catheter to be maximised.
  • the slits 14, both in the container device 10 and the catheter dressing 100 are particularly preferred, in which the first cut 20 has a length comprised between 0.5-8 cm, the further two cuts 21 , 21 ' having a length comprised between 1 and 3 cm. and the angle 22 is comprised between 85°-95°, preferably 90°.
  • Figure 1 also shows a further advantageous aspect of the invention which enables fixing the container device 10 to the patient's skin.
  • the illustrated container device 10 further comprises an auxiliary adhesive strip coupled to the container device 10 in proximity of or at the area 30 adjacent to the slit 14.
  • the auxiliary adhesive layer possesses at least an adhesive side and a portion 41 of surface not superposed on the area 30 and arranged such that the adhesive side is placed in contact with the skin when the slit 14 receives the catheter.
  • the auxiliary adhesive layer superposes the slit 14 the adhesive layer will also have a slit 14 of equal conformation and dimensions.
  • the extension of the surface of the auxiliary adhesive layer is advantageously greater than the area 30 adjacent to the slit 14, entirely covers the area 30 and extends distally to the opening 12 along the longitudinal axis 42 of the device beyond the flap 15.
  • the portion of surface of the auxiliary adhesive layer extending distally could also have a slit superposing the slits 14 of the container device 10 and/or the catheter dressing 100, and which proceeds up to the edge of the auxiliary adhesive layer.
  • Figure 2 further illustrates a particularly advantageous embodiment of a catheter container device 10 in which a catheter dressing according to the invention is applied to the area 30 adjacent to the slit 14 destined to be located in contact with the skin surrounding the catheter.
  • the surface layer 1 10 thereof is arranged such as to be located in contact with the skin when the slit 14 of the device receives the catheter and the slits 14 of the device 10 and the dressing 100 are superposed.
  • At least the area 30 adjacent to the slit 14 and destined to be located in contact with the skin surrounding the catheter comprises at least a substance selected from a group comprising silver, aluminium and derivatives thereof.
  • the area 30 of the catheter container device adjacent to the slit 14 is destined to be located in contact with the skin surrounding the catheter, or the surface layer 1 10 of the catheter dressing 100 are made of a non-stick textile, a non-stick textile fabric having knit weft, a non-woven non-stick textile selected from a group comprising:
  • a textile the fibres of which are covered with silver or aluminium and wherein the aluminium or silver fibres are situated on the surface destined to be placed in contact with the skin (i.e. a textile metallized with silver or aluminium).
  • the surface is the external surface of the surface layer 1 10 destined to be placed in contact with the skin.
  • an anti-stick support permeable to blood and other bodily fluids with silver and/or aluminium the support being a knit, a textile, a non-woven textile made of polyethylene, polyester, viscose, or another material used pharmaceutically.
  • Metallisation can be performed either with classic techniques or using modern and innovative methods such as micro- or nano-deposition.
  • the metallisation of the support reduces the quantity of metal used with respect to the embodiments of a) or b) and is therefore preferable thereto.
  • silver and/or aluminium derivatives or particles of silver and/or aluminium are used, which can be situated either on the area 30 adjacent to the slit 14 and destined to be located in contact with the skin surrounding the catheter and/or on the surface layer 1 10 and/or in the absorbent layer 120 of the catheter dressing.
  • catheter container devices 10 and catheter dressings 100 comprising at least one of the following derivatives of aluminium and silver selected from a group constituted by aluminium sulphate (anhydrous aluminium sulphate and in various forms of hydration thereof) cas numbers 10043-01 -03, 16828-1 1 -8, 16828-12-9 and 7784-31 -8), aluminium and potassium dodecahydrate.
  • aluminium sulphate anhydrous aluminium sulphate and in various forms of hydration thereof
  • cas numbers 10043-01 -03, 16828-1 1 -8, 16828-12-9 and 7784-31 -8 aluminium and potassium dodecahydrate.
  • cas 7784-24-9 metallic aluminium, metallic silver, ionic silver, an inorganic silver salt, in particular silver nitrate, cas 7761 - 88-8; and an organic compound of silver, in particular protein silver, cas 9008- 42-8; vitellinate silver, cas 9015-51 -4, silver alginate and silver sulfadiazine.
  • these compounds can be comprised in at least one of the surface layer 1 10 and absorbent layer 120.
  • the surface layer 1 10 will have a perforated structure or a structure with openings which will allow the absorbent layer 120 to come into contact with the patient's skin.
  • the structure of the surface layer will retain the fibres of the absorbent layer internally of the dressing even during the stage of removal thereof from the skin.
  • An expert in the field according to the type of absorbent material used and the length of the fibres, will be perfectly able to establish the shape of the holes or the openings.
  • the surface layer can be constituted by a textile or a woven cotton material, or polyester, or another material used in the manufacturing of the surface layers of the absorbent medical devices well known to an expert in the field.
  • catheter container devices and catheter dressings of the invention preferably comprise silver or its derivatives.
  • Dressings for catheters of the invention can be manufactured in any geometric shape, for example: square, circular, rectangular, hexagonal, octagonal, oval, triangular, and more besides.
  • Square catheter dressings are particularly suitable, having a side length comprised between 3 and 8 cm, or rectangular with sides comprised between 2.5 and 8 cm or circular with a diameter comprised between 2.5 and 8 cm.
  • the pouch 1 1 too can be of various shapes and sizes, according to the type and length of the catheter, which they will contain, through preferably rectangular or square, as these are easier to make.
  • catheter dressing 100 is applied on a plaster, an elastic bandage, a self-adhesive bandage, as they enable fastening the single catheter dressing 100 to the body.
  • the above-mentioned surface layer of the dressing 100 is preferably anti-stick, and without projecting fibrous particles.
  • the absorbent layer can be constituted by a gauze absorbent made of hydrophilous cotton, or non-woven textile or expandable dressings constituted by a single spongy material such as synthetic felt or ribbon polypropylene or viscose for pharmaceutical use.
  • An absorbent layer made of viscose or viscose-polypropylene is preferred, having a thickness comprised between 0.1 and 15 mm or greater, according to the clinical situation. More preferable is a thickness comprised between 1 and 4 mm and having an absorbent power of
  • 500-1500% in a second and even more preferable is 700-1500% in a second.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention porte sur un dispositif contenant un cathéter, d'un type constitué par une poche (11), accessible par l'extérieur par l'intermédiaire d'une ouverture (12), la poche (11) étant constituée par deux parois opposées (13, 13'). L’invention est caractérisée en ce qu'au moins l'une des parois (13, 13') contient une fente (14) destinée à recevoir le cathéter contenu dans la poche (11) selon un couplage libre.
PCT/EP2009/064144 2008-10-29 2009-10-27 Dispositif contenant un cathéter, pansement pour cathéter et kit renfermant l'un et l'autre WO2010049417A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2741926A CA2741926C (fr) 2008-10-29 2009-10-27 Dispositif contenant un catheter, pansement pour catheter et kit renfermant l'un et l'autre

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO2008A000661A IT1391498B1 (it) 2008-10-29 2008-10-29 Dispositivo di contenimento per catetere, tampone per cateterismo e kit che comprende entrambi
ITBO2008A000661 2008-10-29

Publications (1)

Publication Number Publication Date
WO2010049417A1 true WO2010049417A1 (fr) 2010-05-06

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ID=41137698

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/064144 WO2010049417A1 (fr) 2008-10-29 2009-10-27 Dispositif contenant un cathéter, pansement pour cathéter et kit renfermant l'un et l'autre

Country Status (3)

Country Link
CA (1) CA2741926C (fr)
IT (1) IT1391498B1 (fr)
WO (1) WO2010049417A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITBO20100408A1 (it) * 2010-06-25 2011-12-26 Emodial S R L Dispositivo per il contenimento della porzione esposta di un catetere impiantato in un paziente
WO2012161897A3 (fr) * 2011-05-26 2013-03-14 Carefusion 2200, Inc. Système de pansement
EP2982355A1 (fr) * 2014-08-04 2016-02-10 Iberhospitex S.A. Pansement auto-adhésif
CN109550076A (zh) * 2018-12-08 2019-04-02 郑州和济生物科技股份有限公司 医用聚硅酮臭氧油凡士林敷料及基于该敷料的创面护理贴

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3020574B1 (fr) 2014-04-30 2016-06-24 Nephrokit Dispositif de protection d'un catheter

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4324237A (en) * 1980-02-26 1982-04-13 E-Med Corporation Intravenous catheter and tubing securement and dressing device with a window over the puncture or wound site
EP0284219A2 (fr) * 1987-03-14 1988-09-28 Smith & Nephew plc Bandages adhésifs, leur préparation et utilisation
WO2001068179A1 (fr) * 2000-03-13 2001-09-20 Nucryst Pharmaceuticals Corp. Pansements pour dispositifs medicaux transcutanes et procede d'utilisation
US20020068903A1 (en) * 2000-12-01 2002-06-06 Beausoleil Annette A. Catheter holding system
WO2006085085A1 (fr) * 2005-02-11 2006-08-17 Unomedical Limited Dispositif de fixation d'un tube par rapport a la peau d'un patient et assemblage du tube et du dispositif
WO2007011596A2 (fr) * 2005-07-14 2007-01-25 Medical Device Group, Inc. Pansement de protection et methodes d'utilisation
US20070225652A1 (en) * 2006-03-09 2007-09-27 Scherr George H Catheter patch

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4324237A (en) * 1980-02-26 1982-04-13 E-Med Corporation Intravenous catheter and tubing securement and dressing device with a window over the puncture or wound site
EP0284219A2 (fr) * 1987-03-14 1988-09-28 Smith & Nephew plc Bandages adhésifs, leur préparation et utilisation
WO2001068179A1 (fr) * 2000-03-13 2001-09-20 Nucryst Pharmaceuticals Corp. Pansements pour dispositifs medicaux transcutanes et procede d'utilisation
US20020068903A1 (en) * 2000-12-01 2002-06-06 Beausoleil Annette A. Catheter holding system
WO2006085085A1 (fr) * 2005-02-11 2006-08-17 Unomedical Limited Dispositif de fixation d'un tube par rapport a la peau d'un patient et assemblage du tube et du dispositif
WO2007011596A2 (fr) * 2005-07-14 2007-01-25 Medical Device Group, Inc. Pansement de protection et methodes d'utilisation
US20070225652A1 (en) * 2006-03-09 2007-09-27 Scherr George H Catheter patch

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITBO20100408A1 (it) * 2010-06-25 2011-12-26 Emodial S R L Dispositivo per il contenimento della porzione esposta di un catetere impiantato in un paziente
WO2012161897A3 (fr) * 2011-05-26 2013-03-14 Carefusion 2200, Inc. Système de pansement
EP2982355A1 (fr) * 2014-08-04 2016-02-10 Iberhospitex S.A. Pansement auto-adhésif
CN109550076A (zh) * 2018-12-08 2019-04-02 郑州和济生物科技股份有限公司 医用聚硅酮臭氧油凡士林敷料及基于该敷料的创面护理贴
CN109550076B (zh) * 2018-12-08 2023-09-01 郑州和济生物科技股份有限公司 医用聚硅酮臭氧油凡士林敷料及基于该敷料的创面护理贴

Also Published As

Publication number Publication date
IT1391498B1 (it) 2011-12-30
CA2741926A1 (fr) 2010-05-06
ITBO20080661A1 (it) 2010-04-30
CA2741926C (fr) 2017-03-07

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