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WO2008135551A2 - Charge pour cavité de lit de plaie et dont le gonflement induit par l'absorption est contrôlée - Google Patents

Charge pour cavité de lit de plaie et dont le gonflement induit par l'absorption est contrôlée Download PDF

Info

Publication number
WO2008135551A2
WO2008135551A2 PCT/EP2008/055490 EP2008055490W WO2008135551A2 WO 2008135551 A2 WO2008135551 A2 WO 2008135551A2 EP 2008055490 W EP2008055490 W EP 2008055490W WO 2008135551 A2 WO2008135551 A2 WO 2008135551A2
Authority
WO
WIPO (PCT)
Prior art keywords
bits
product
product according
string
foam
Prior art date
Application number
PCT/EP2008/055490
Other languages
English (en)
Other versions
WO2008135551A3 (fr
WO2008135551A8 (fr
Inventor
Chaabane Bougherara
Patrik Gavelin
Peter Kwok Hing Lam
Original Assignee
Coloplast A/S
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 Coloplast A/S filed Critical Coloplast A/S
Publication of WO2008135551A2 publication Critical patent/WO2008135551A2/fr
Publication of WO2008135551A8 publication Critical patent/WO2008135551A8/fr
Publication of WO2008135551A3 publication Critical patent/WO2008135551A3/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/36Surgical swabs, e.g. for absorbency or packing body cavities during surgery

Definitions

  • This invention relates to a product suitable for absorbing fluid from wounds during the healing process.
  • I t is known from the prior art to use bits or individual discrete com ponents or balls or blocks as absorbent and arranging them on a string or in a net.
  • the product in this form has a large wound contact surface enabling good fluid m anagem ent and release of actives.
  • This form also allows the product to be tightly packed into a wound cavity and yet easily rem oved.
  • the product can be cut to length to fit wounds of varying size.
  • EP 0575090 discloses a product suitable for absorbing wound exudate com prising a series of interconnected square or rectangular perforated bags m ade of a substance of m axim u m thickness 1 m m e.g. film , which is substantially non-adherent to a wound, wherein alginic acid or a salt thereof such as calcium alginate is housed in the bags, preferably in the form of sm all spheres.
  • the film preferably com prises ethylene/ m ethyl acrylate copolym er.
  • the product com prises a string along which beads of alginic acid or alginate are threaded.
  • US Patent No. 5470625 discloses an elongated segm ented wound packing product com prised of individual linked segm ents of hydrogel enclosed within a liquid perm eable pliable m aterial, the individual segm ents being connected in a strand-of-beads like configuration .
  • US Patent No. 3095877 discloses as a surgical packing a nylon thread on which is spaced a plurality of equally spaced half inch diam eter balls, typically m ade of foam m aterial such as urethane foam or foam rubber.
  • bits or individual discrete com ponents or balls or blocks according to the prior art are m anufactured in one process, which often require cutting and sorting.
  • the threads and the nets are m ade of different m aterial from the absorbent com ponents to provide strength and con nectivity. Generally, these m aterials are not functional as absorbents.
  • the net or string is exposed in part or in full on the product when in use and m ay be m ade of harder m aterial, or with less skin friendly surfaces, thereby discom forting and aggravating the wound bed.
  • This product is m anufactured by a one step process, which is saving both tim e and m aterial.
  • the product of the invention is giving absorbing ability to the whole length of the product. Furtherm ore, the absorbent surface of the product is soft and m oist, thereby giving these characteristics to the whole product, which m akes the product of the invention m ore user friendly.
  • the present invention relates to a product suitable for absorbing fluid from wounds during the healing process and a m ethod for m anufacturing such a product.
  • the product suitable for absorbing wound exudate comprising bits interconnected by a string, wherein the bits and the strings are consisting of the same absorbent material.
  • FIG.1 is a top plan view of an embodiment of the invention and it illustrates the wound packing product of the invention.
  • FIG.2 is a top plan view thereof showing an embodiment of the invention where the cut sheets are assembled together.
  • FIG.3 illustrates a two-step cutting method of preparing the wound packing product of the invention.
  • FIG.4 illustrates a preferred embodiment of the wound packing product of the invention where the product is further strengthened by having a continuous net or string on the inside.
  • FIG.5 illustrates an extrusion and/or moulding method of preparing the wound packing product of the invention.
  • the present invention relates to a product suitable for absorbing fluid from wounds during the healing process.
  • the product suitable for absorbing wound exudate comprising bits interconnected by a string, wherein the bits and the strings are consisting of the same absorbent material.
  • the product according to the present invention is manufactured by a one step process, which is saving both time and material.
  • the product of the invention comprises bits interconnected by a string (an interconnecting element/member).
  • the bits and the strings are consisting of the same absorbent material. This allows the bits and the string to provide an identical absorption capacity, whereby the whole length of the product may have the same absorption capacity.
  • the interconnecting member/element and the bits define a monolithic element, i.e. defining one element with out seams.
  • the density and/or the buoyancy of the bits and the strings are substantially identical.
  • the product according to the present invention defines a plurality of bits (spheres/balls/dices/cubes) and a plurality of interconnecting members.
  • any two neighbouring bits are interconnected by an interconnecting member. Accordingly, each of the interconnecting members (except those defining one of the two ends of the string) is connected to two bits only.
  • the product of the invention can also be understood as a continuous string or 'sausage' having fat and thin segments where the thin segments provide extra flexibility for bending and folding, hence enhancing the flexibility of the entire product, as the strings/interconnecting members enable the product to be packed into cavities, e.g. of a wound.
  • the fat segments may correspond to the bits/spheres/balls/dices/cubes and the thin segments may correspond to the string(s)/interconnecting member(s) .
  • bits and string parts may be connected mechanically or chemically, preferably by one step moulding or extruding method.
  • the bits-and-string-product may be treated, if needed, to prevent adhesion to each other or to the wound bed.
  • the treating material may be polyvinyl-alcohol, polyvinylpyrrolidone or any other coating with swelling properties known in the art.
  • bits and strings may be cut to required size.
  • the disadvantage as mentioned above having a product comprising two different materials has been eliminated by using the same absorbent material for the bits as well as for the strings.
  • the absorbent surface of the product is soft and moist, thereby giving these characteristics to the whole product, which makes the product of the invention more user friendly. At least a part of the user friendliness is achieved by the soft and moist surface of the produce, as it will be appreciated that a moist and soft surface is less or non painful to have inserted into, to wear in and to have removed from a wound relative to a hard and non-moist surface.
  • the absorbent material can be in the form of a foam or a hydrogel.
  • foam shall be understood as an open or closed cell flexible material.
  • the absorption capacity of the absorbent material is greater than 25% of its own weight, preferably greater than 100% of its own weight. In one embodiment the absorption capacity is in the range 100-5000%, such as in the range 500- 2500%, such as in the range 1000-2000%
  • the absorbent hydrogel may preferably be of the type described in US Patent No.4593053, the entire content of which is incorporated herein by reference. These hydrogels are of the hot melt type as is fully described in US Patent No. 5002792, the entire content of which is incorporated herein by reference.
  • Other materials may also be used, not necessarily of the hot melt type, such as calcium alginate, polyethylene oxide, polyacrylates , hydrophilic urethane and polyvinylpyrrolidone, to name a few other hydrogels.
  • Non-hydrogels may also be used as the absorbent material.
  • sponge-like materials available from Avitar, Inc., of Cantor, Mass. under the trademark Hydrosorb.TM. may be used.
  • Foam-like materials available from Acme United Corporation, Medical Products Division, of Fairfield, Conn.0640, under the trademark Lyofoam.RTM. may also be used. This is a specially treated polyurethane.
  • Foam materials may include, but are not limited to, silicone, polyacrylates, polyethylene oxide, polypropylene oxide, and polyurethane.
  • a preferred foam material to be used is available from Coloplast A/S under the trademark Biatain. The foam is preferably the open cell type.
  • Bits can take various forms. Thus, they can be spheres or rectangular. In general, by bit is meant any small discrete quantity, which needs not be regular in shape.
  • the shape of the bits can vary but preferred are substantially spherical, rectangular or square bits.
  • the bits are in the form of small spheres, and particularly spheres having a diameter of 1 mm to 50 mm, for example 5 mm.
  • sphere it is not meant that it has to be a geometrically perfect sphere.
  • the string has a thickness or diameter 1 to 50% of that of the bits.
  • the product is made of a substance of maximum thickness 50 mm.
  • the product is further strengthened by having a continuous net, film or string on the inside of the absorbent material.
  • the strengthening string, film or net can be a thin length of cord, thread, twine, fibre, woven or non-woven, or similar material, a continuous or perforated film, and may be of natural or synthetic material. Thus it may be a nylon thread. It can be hydrophilic but not water soluble, for example cross-linked.
  • fibrous materials which may be used as the strengthening string, film, or net are polyolefins such as polyethylene, polypropylene and polybutylene homopolymers and copolymers, polyethers, polyurethanes, vinyl polymers such as polyvinylchloride, polyamides such as nylon, and polyesters.
  • Other fibres include rayon and acrylic fibres.
  • the bits and/or the strings could contain active wound healing agents, for example growth factors, collagen, glycosaminoglycans, vitamins, antiseptic agents and enzyme debriders.
  • Figure 1 shows a series of bits interconnected by a string.
  • the bits are illustrated as squares and the strings are illustrated as having the same length as the bits.
  • foam sheets can be cut out to provide the st rings- and- bit s form where smaller segments which are more flexible than the broad segments connecting the latter together.
  • Figure 3 illustrates a preferred method of cutting in 3-dimension by a two step cutting or rotating cutting. Any method of cutting known in the art can used for the cutting, for example by press and stamping out, heat or laser cutting.
  • a plurality of series of bits interconnected by a string are connected in a 2-dimension form of a net or in a 3-dimension form of a matrix.
  • Figure 2 is illustrating an embodiment of the invention where the cut sheets are assembled together by glue or by other means to provide higher volume.
  • a film or net or string may be sandwiched between the layers for further strengthening.
  • Figure.4 illustrates a preferred embodiment of the wound packing product of the invention where the product is further strengthened by having a continuous net, film or string on the inside.
  • FIG.5 illustrates an extrusion and/or moulding method of preparing the wound packing product of the invention. This can be done in a continuous or batch process.
  • the pre-formed absorbent material is put into a mould and activated to form, by crosslinking and foaming, a stable bits and string product. Examples
  • the retention and the extension may be determined using a procedure comprising the following steps:
  • the foam may be provided as a sheet of foam with a thickness of 3-4 mm;
  • step 13 and 14 repeating step 13 and 14 until the pad has been rolled between new dry paper three times all in all.
  • each of the weight and the diameter must be identical in the equations, i.e. the compressed weight, the dry weight and the absorption weight must be provided in the same unit, such as grams, and the wet diameter and the dry diameter must be provided in the same unit, e.g. millimetres.
  • Example One the unit of each of the weight and the diameter, must be identical in the equations, i.e. the compressed weight, the dry weight and the absorption weight must be provided in the same unit, such as grams, and the wet diameter and the dry diameter must be provided in the same unit, e.g. millimetres.
  • Polyurethane foam spheres/balls were obtained by moulding at room temperature (20-25 degrees Celsius) for 3 minutes with a mixture based on RECIPE ONE.
  • the mould into which the mixture was poured during the moulding process was shaped such that the moulding process resulted in a plurality of spheres/balls each of which has a diameter of 10 mm.
  • any two neighbouring spheres/balls were interconnected by an interconnecting member having a thickness (a diameter in the case of circular interconnecting member) of 1 mm.
  • the length of each of the interconnecting members were 3 mm. Accordingly, the spheres/balls were spaced apart by a distance of 3 mm.
  • the retention and extension were determined by means of the abovementioned method.
  • the retention is indicated in the terms of "grams of liquid per grams of foam” [g/g].
  • the extension is indicated in terms of extension of volume as a result of absorption of fluid.
  • Example Two is identical to Example One, with the difference that the foam was based on RECIPE ONE A, and thus contained a pain reducing agent such as Ibuprofen.
  • the content of lbuprofen content was measured by HPLC, using Dionex Ultimate 3000 equipment
  • Example Three is identical to Example One, with the difference that the foam was based on RECIPE ONE B, and thus contained an anti microbial ingredient such as silver complex (Ag + ).
  • the content of Ag + was determined by atomic absorption using a Perkin Elmer equipment, type "AAnalyst 100".
  • Example Four Example Four is identical to Example One, with the difference that the foam was based on RECI PE THREE.
  • Example Four is identical to Example One, with the difference that the foam was based on RECIPE TWO and that the foam moulding process took place at a temperature of 50 degrees Celsius and not at room temperature, i.e. the temperature of the mould into which the foam was poured/injected had a temperature of 50 degrees Celsius.
  • Example Six A rod-shaped foam element with a diameter of 10 mm were obtained by moulding a polyurethane masse based on RECIPE ONE at room temperature.
  • the rod-shaped foam element were cut by means of a cutting tool, into a monolithic element (i.e. one single element with out seams) defining a plurality of spheres/balls interconnected by a plurality of interconnecting members.
  • Example Six the diameter of each of the spheres/balls were identical to the diameter of the rod-shaped foam element i.e. 10 mm.
  • the monolithic element defined a plurality of interconnecting members, each of which interconnected two neighbouring spheres/balls.
  • Each of the interconnecting members had a length of 3 mm.
  • the cross-section of each of the interconnecting members was rectangular such that one side of the rectangular cross-section was 10 mm and another transverse side was 1 mm.
  • Example Seven is identical to Example Six, with the difference that the polyurethane foaming masse was based on RECIPE FIVE.
  • the foam of Example Eight was based on Corpura Foam MCF 03.
  • the foamed material were cut so as to from a monolithic element comprising a plurality of dices. Any two neighbouring dices were interconnected by an interconnecting member.
  • Each of the dices had the following dimensions: 10 mm x 10 mm x 10 mm.
  • the interconnecting members each of which interconnected two neighbouring dices were 3 mm long and had a rectangular cross-section with the dimensions 3 mm x 2 mm.
  • Example Eight Comprising Corpura Foam MCF 03, Batch 0803121238):
  • a welding tool was utilised to form a plurality of spheres/balls each of which had a diameter of 10 mm. Any two neighbouring spheres/balls were interconnected by an interconnecting member.
  • Each of the interconnecting members was 3 mm long and had a rectangular cross section with the dimensions 1mm x 3mm.

Landscapes

  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Epidemiology (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)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un produit adapté pour l'absorption d'un fluide provenant de plaies lors du processus de guérison et un procédé de fabrication dudit produit.
PCT/EP2008/055490 2007-05-03 2008-05-05 Charge pour cavité de lit de plaie et dont le gonflement induit par l'absorption est contrôlée WO2008135551A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200700670 2007-05-03
DKPA200700670 2007-05-03

Publications (3)

Publication Number Publication Date
WO2008135551A2 true WO2008135551A2 (fr) 2008-11-13
WO2008135551A8 WO2008135551A8 (fr) 2009-02-05
WO2008135551A3 WO2008135551A3 (fr) 2009-04-09

Family

ID=38215006

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/055490 WO2008135551A2 (fr) 2007-05-03 2008-05-05 Charge pour cavité de lit de plaie et dont le gonflement induit par l'absorption est contrôlée

Country Status (1)

Country Link
WO (1) WO2008135551A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014062839A1 (fr) * 2012-10-16 2014-04-24 Surmodics, Inc. Dispositif de pansement et procédés
US10201457B2 (en) 2014-08-01 2019-02-12 Surmodics, Inc. Wound packing device with nanotextured surface
WO2022101711A1 (fr) * 2020-11-11 2022-05-19 3M Innovative Properties Company Article absorbant, système absorbant et système de distribution

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1997467A (en) * 1931-12-29 1935-04-09 Johnson & Johnson Method and product for selective conversion articles
US3095877A (en) * 1961-05-01 1963-07-02 Robert L Rowan Surgical packing
US3797496A (en) * 1972-05-06 1974-03-19 Physio Medics Inc Post-extraction pads
US4120299A (en) * 1976-04-23 1978-10-17 Russo Joseph J Snore-prevention article and process for manufacturing the same
US5374261A (en) * 1990-07-24 1994-12-20 Yoon; Inbae Multifunctional devices for use in endoscopic surgical procedures and methods-therefor
GB9212303D0 (en) * 1992-06-10 1992-07-22 Johnson & Johnson Medical Ltd Absorbent products
US5470625A (en) * 1993-12-21 1995-11-28 Medtronic, Inc. Strand-of-beads wound packing product
US6530934B1 (en) * 2000-06-06 2003-03-11 Sarcos Lc Embolic device composed of a linear sequence of miniature beads
GB2376632B (en) * 2001-06-21 2004-10-27 Johnson & Johnson Medical Ltd Removable cavity wound dressing

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014062839A1 (fr) * 2012-10-16 2014-04-24 Surmodics, Inc. Dispositif de pansement et procédés
JP2015532174A (ja) * 2012-10-16 2015-11-09 サーモディクス,インコーポレイテッド 創傷充填デバイスおよび方法
US10080688B2 (en) 2012-10-16 2018-09-25 Surmodics, Inc. Wound packing device and method
US10201457B2 (en) 2014-08-01 2019-02-12 Surmodics, Inc. Wound packing device with nanotextured surface
WO2022101711A1 (fr) * 2020-11-11 2022-05-19 3M Innovative Properties Company Article absorbant, système absorbant et système de distribution
CN116437885A (zh) * 2020-11-11 2023-07-14 3M创新有限公司 吸收制品、吸收系统和分配系统

Also Published As

Publication number Publication date
WO2008135551A3 (fr) 2009-04-09
WO2008135551A8 (fr) 2009-02-05

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