WO1993007843A1 - Pansement - Google Patents

Pansement Download PDF

Info

Publication number
WO1993007843A1
WO1993007843A1 PCT/AU1992/000558 AU9200558W WO9307843A1 WO 1993007843 A1 WO1993007843 A1 WO 1993007843A1 AU 9200558 W AU9200558 W AU 9200558W WO 9307843 A1 WO9307843 A1 WO 9307843A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
dressing
skin
adhesive
base member
Prior art date
Application number
PCT/AU1992/000558
Other languages
English (en)
Inventor
Ian L. Airey
Original Assignee
Gelambi Pty. Ltd.
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 Gelambi Pty. Ltd. filed Critical Gelambi Pty. Ltd.
Publication of WO1993007843A1 publication Critical patent/WO1993007843A1/fr

Links

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
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • 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
    • A61F2013/00421—Plasters use for use with needles, tubes or catheters with double adhesive layer
    • 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
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00553—Plasters form or structure with detachable parts
    • A61F2013/00561—Plasters form or structure with detachable parts with adhesive connecting means
    • 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
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00604—Multilayer
    • 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
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
    • 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
    • A61F2013/00795—Plasters special helping devices
    • A61F2013/00825—Plasters special helping devices protection of wound surround

Definitions

  • This invention relates to dressing apparatus.
  • This invention has particular but not exclusive application to a dressing apparatus adapted to secure an intravenous cannula or the like, and for illustrative purposes reference will be made to such application.
  • the patients Following surgical or anaesthetic procedures, the patients often ' are attached to some indwelling device which may be required for a few hours or a number of days or weeks. It is important for hospital staff to ensure that these devices are securely attached to the patient and are unlikely to be dislodged, and that the method of securing the device is easy to apply and comfortable for the patient.
  • the weak link in the delivery system is where the intravenous cannula or catheter enters the skin or orifice of the patient. Luer lock connections are also used when indwelling cannulae are inserted into arteries for various reasons. A break in the system here can be dangerous resulting in significant haemorrhage. Again, the weak link is where the cannula enters the skin. Although it is unlikely that the patient will bleed to death if the
  • drains are sometimes inserted into the ventricles of the brain to relieve intracranial pressure. Dislodgement of this or other intracranial drains may prove to be life threatening. Similarly, inappropriate removal of drains in general may result in the accumulation of blood o abscess formation. Displacement of chest drains can resul in the development of a pneu othorax which, if it become tense, may prove to be life threatening. Patients requiring repeated courses of chemotherap often have reservoirs secured under the skin which then drai into a central vein. When the administration of drugs ar required, a special needle is inserted through the skin int the reservoir. If this needle becomes dislodged befor completion of the treatment, it has to be re-inserted causin unnecessary discomfort to the patient.
  • 3918446 discloses a device for securing to the skin an infusion needle and including a slotted polyurethane foam lower pad adapted to be adhered to the skin about the inserted infusion needle.
  • a second polyurethane pad having an adhesive surface is then overlaid the first, entrapping the tube feeding the needle.
  • the disadvantage of the apparatus disclosed lies in the fact that the tube is unsupported before the second pad is installed. Accordingly, the user must secure in one hand the tube whilst installing the cover. Additionally, the removable nature of the adhesive system used in respect of the second pad results in compromising the security of the apparatus for such removability.
  • US Patent No. 4799923 discloses apparatus for securing tubes such as gastrostomy tubes to a patient and including an openable slotted pouch secured to the patient by adhesive and wherein the outer flap of the pouch may be removably secured by hook-pile fastening to the slotted base to secure the free portion of the tube.
  • Such apparatus is unsuitable for securing cannulae or the like since the hook pile fastening does not directly secure the tube of a cannula and the small size thereof tends to permit . tension to be translated to the needle.
  • 3683911 discloses an adhesive cannu shield adapted to be adhered about a cannula entry point a comprising a split, integral adhesive base and tube assembl the inner surface of the tube having an adhesive adapted seal about the cannula tube.
  • the disclosed apparatus has t inherent disadvantage that the cannula tube juts outwardly the plane of the base portion. Additionally, whilst suc apparatus will probably achieve its aim of excluding bacteri from the insertion wound, the apparatus is cumbersome to us by virtue of the operator having to force the apparatu apart at the split and instal same on the patient whilst th exposed adhesive tends to pick up the tube and the skin o the patient before the apparatus is properly placed.
  • 10082/88 discloses a adhesive pad adapted to engage the skin of a patient about needle insertion site and including a support for a cable ti like retaining means for the tube of the inserted device.
  • disadvantage of the apparatus disclosed relates to the protruding nature of the support and tie assembly which tends to snag, as well as a limitation on the security of the apparatus if the tie is inadvertantly not pulled up tight enough. Further, even if the tube is gripped, the proximity of the tie to the needle coupled with the flexibility of the base member provides a tendency for the needle to work around in the patient if lateral loads are placed on the support and tie assembly by movement of the tube or snagging.
  • PCT/EP89/01273 discloses a dressing for adhesion about an intravenous cannula and having an anti-inflammatory substance incorporated on the skin side, with or without a pad incorporating an antithrombophlebitic substance.
  • the cannula tube is supported on the dressing by small adhesive tabs. The use of small adhesive tabs provides in practice poor security against dislodgement of the cannula.
  • the various apparatus include the further disadvantage that upon placement of the dressing, the tube of the cannula must be manipulated in a way which generally requires two hands of the operator or an assistant. Where the cannula must be for example elevated above the patient, this may provide practical difficulties in use.
  • the present invention aims to alleviate the above disadvantages and to provide a dressing apparatus which will be reliable and efficient in use. Other objects and advantages of this invention will hereinafter become apparent.
  • this invention in one aspect resides broadly in dressing apparatus for securing a cannula or the like to the skin of a patient and including a sheet of flexible dressing material having on its lower surface an adhesive for engaging the skin of the patient about said cannula or the like and having on its upper surface an adhesive adapted to adhesively engage a portion of said cannula or the like overlying said dressing material in use.
  • the sheet of flexible dressing material comprises a flexible base member having an adhesive lower layer adapted to engage the skin of the patient about sa cannula or the like.
  • the dressing apparatus may furth comprise a cover member having an adhesive layer adapted overlie the base member, such that the upper surface adhesi of the base member, preferably in the form of an upp adhesive layer, is adapted to adhesively engage both portion of the cannula or the like and the adhesive layer the cover member in use.
  • the term 'cannula or the like' means a apparatus adapted to engage or pierce the skin or other pa of the body of a patient, for any purpose includi diagnosis and therapy.
  • the term 'patient' in this conte includes both human and animal subjects.
  • the prese invention will be described hereinafter with reference t apparatus suitable .for use in conjunction with cannula fo intravenous, subdermal or intramuscular use, epidura anaesthesia, cerebrospinal taps and drains from any bod cavity either natural or surgically created.
  • the flexible base member may be of any suitable materia such as woven or nonwoven cloth, paper or other like dressin material.
  • the flexible base member comprises patch of dressing material.
  • the flexible base member may b of opaque material or may be comprised of transparen dressing material.
  • the dressing material i selected such that the adhered dressing may freely transpir moisture such that perspiration under the dressing may b dissipated without significantly reducing the adherence to the patient's skin.
  • the flexible base member may include an absorbent pad on the side to be adhered to the subject, where the apparatus is to be used in conjunction with penetrative appliances such as cannulae, but it is envisaged that embodiments of the present invention may dispense with the absorbent pad or include therewith for example antiseptic or other medicament dispensing patches or pads.
  • the base member may be adapted for adherence to the skin of the patient about the appliance's entry or attachment point by provision of an aperture or the like through, the base member.
  • the aperture or the like may be adapted to permit the insertion of a cannula or attachment of another type of appliance whilst the base member is adhered to the patient, such as may be achieved by use of an aperture of closed perimeter.
  • the aperture take the form of a slot cut in to the base member from one edge thereof.
  • the base member may be applied such that the slot is substantially aligned with the plane of insertion of the cannula.
  • locating means associated with the base member of any suitable form dictated by the appliance to be used.
  • the appliance comprises an electrode or the like
  • the locating means may comprise a clip or the like mounted on the base and adapted to engage the lead or body of the electrode and thereby resist tension in the lead from tending to dislodge the electrode.
  • the locating means may comprise a clip as before, but may also be selected from a luer lock element or the like affixed to the base, or hook- pile material adapted to engage the cannula tube, or a combination of such and like locating means.
  • the adhesive comprising the lower adhesive layer may take any suitable form known in the art of adhesive dressings.
  • the adhesive layer comprises a skin compatible pressure sensitive adhesive coating the dressing material.
  • the adhesive layer may comprise a adhesive composition of an acrylic copolymer or polymer, tackifiers and fillers as is well known in the art.
  • the adhesive cover member may be of any suitable materia such as a flexible dressing material similar to tha preferred in respect of the base member although it need not necessarily be so.
  • the adhesive cover member comprises a tenacious adhesive coating applied to a flexible woven, sheet or web material.
  • the adhesive coating is adapted to strongly adhere to the corresponding adhesive coating provided on the exposed face of the base member. Accordingly, whilst it is preferred that the skin side of the base member be provided with adhesive which is compatible with skin, the adhesive on the side of the base member remote from the skin, and if desired on the corresponding adhesive coated surface of the cover member, may be of a particularly tenacious adhesive not necessarily of a type proposed for skin adhesion.
  • the cannula tube be attachable in a one-handed manner by the operator simply pressing the tube against the upper adhesive layer and preferable imparting one or more coils to the tube whilst this is performed.
  • the device will, in this configuration, remain fixed in position while the cover member is applied by the operator who has, if required, remained sterile.
  • the area of exposed adhesive maximises the configuration options available to the operator when locating the device making the dressing adaptable to different sites of the body and different sizes of patients.
  • the cover member be adapted to overlie the base member and extend beyond the edges thereof to adhere to the surrounding skin of the patient such that the security of the apparatus is enhanced, and it is accordingly preferred that the adhesive associated with the cover member be skin compatible in at least the region of skin contact.
  • the apparatus is provided as a dressing kit wherein the adhesive surfaces of the base member and the cover member are protected by a release film or the like.
  • the dressing components may be removed from sterile packing and the cannula inserted into the patient.
  • the dressing base member may then have its release coating removed on its skin side surface and applied to the skin with its slot disposed along and about the cannula.
  • the release film now exposed on the base member may then be removed, and the tube feeding the cannula may be adhered to the exposed adhesive.
  • the tube is disposed in such a way as to maximize or enhance the securing thereof by the adhesive.
  • the tube may be coiled on the adhesive pad, or alternatively may be laid away from the line of the cannula to exit in a substantially transverse direction.
  • the release coating of the cover member may then be removed and the securing member adhered over the cannula, tube and base member to secure the cannula from inadvertant dislodgement.
  • this invention related broadly to a method of retaining a cannula or the like on or through the skin of a patient and including the steps of:- applying said cannula or the like through or to the skin of the patient; adhering to the skin about said cannula an adhesive flexible dressing material including an adhesive on its upper surface, and adhesively engaging a portion of said cannula or the like with said upper adhesive layer.
  • the method further includes securing the cannula or the like with a cover member having an adhesive layer adapted to overlie both the dressing material and the cannula portion.
  • the cover member may be selected to overlie a portion of the patients skin exposed beyond the edges of the dressing material.
  • FIG 2 is a detail view of part of the cross-section o
  • FIG 3 is' a plan view of apparatus in accordance with Fi 1;
  • FIG 4 is a bottom plan view of the apparatus of Fig 1 i use.
  • a dressing 1 comprising a sterile kit having included a base member 11 an a- securing member 12, both of woven dressing material. Th base member is provided with an integral absorbent pad 13.
  • a slot 14 is cut into the centre of the base member 11 an absorbent pad 13 from an edge of the base member 11.
  • the base member 11 is provided with a skin compatibl adhesive layer 15 about the absorbent pad 13 and adapted t bond the base member 11 to the skin of a patient.
  • the oute surface of the base member 11 is provided with a high strength adhesive layer 16. Both the skin compatibl adhesive layer 15 and high strength adhesive layer 16 ar covered prior to use with release layers 17.
  • the securing member 12 is similarly provided on its inne surface with a skin compatible adhesive layer 20, and the securing member 12 is also of dimension to extend beyond the periphery of the base member in use and adhere both to the upper, high-strength adhesive layer of the base member and the skin surrounding the base member 11.
  • the securing member 12 is advantageously overlapping the base member 11 by approximately 1.5 cm.
  • a cannula (not shown) is inserted into the patient and the release layer 17 on the skin side of the base member 11 removed for placement of the base member 11 abou the inserted cannula such that the absorbent pad 13 i centred on the entry point of the cannula through the skin.
  • the release layer 17 on the bac of the base member 11 is removed and the tube 21 attached t the cannula is given at least one coil and laid out on th adhesive surface 16.
  • the release layer 17 on the securing member 12 is remove and the securing member 12 laid over the base member 11 t entrap the tube 21 and accordingly the cannula in its selected position by inter-layer adhesion between the high- strength adhesive layer 16 and the skin compatible adhesive layer 20.
  • the tube 21 is effectively surrounded by adhesive giving it the protection and security.
  • the absorbent pad 13 is advantageous in absorbing any blood or serum which may ooze from the site of insertion of the device. As well as this, it provides a cushion between the device and the patient's skin, facilitating patient comfort should the device be required to be in place for some period of time. Also, it will reduce the likelihood of the device being kinked at the skin edge.
  • Apparatus in accordance with the above described embodiment has proved to have particular ease of application compared to prior art methods of application.
  • the apparatus in accordance with the abovedescribed embodiment provides for security against displacement of the attached penetrating apparatus in the installation stage where even unwieldy appliances may be precisely placed and retained by adherence to the lower layer prior to the placement of the adhesive top layer. After installation of the adhesive top layer the substantially inseparable adhesive to adhesive bond secures the appliance effectively for the long term.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un pansement (10) permet de fixer une canule au corps du patient. Il prend la forme d'un ensemble stérile comprenant une base (11) fendue en (14) et un tampon absorbeur (13), une couche inférieure adhésive (15) dermo-compatible, ainsi qu'une couche adhésive supérieure résistante (16) et une surface de fixation (12) comportant une couche adhésive dermo-compatible (20). La base comme la surface se composent d'un matériau de pansement. Les couches adhésives dermo-compatible (15) et supérieure résistante (16) sont, avant usage, recouvertes de languettes de protection 917). La surface de fixation (12) déborde la périphérie de la base pendant l'usage. Une canule est introduite dans le corps du patient et l'on retire la languette de protection (17) placée côté peau sur la base, cette dernière venant entourer la canule, après quoi l'on retire la languette de protection (17) placée au dos de la base. Le tube (21) relié à la canule est enroulé sur un tour puis fixé sur la surface adhésive (16). On retire la languette de protection (17) de la surface de fixation (12) que l'on pose sur la base (11) de manière à assujetir le tube (21) solidement.
PCT/AU1992/000558 1991-10-22 1992-10-19 Pansement WO1993007843A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPK905691 1991-10-22
AUPK9056 1991-10-22

Publications (1)

Publication Number Publication Date
WO1993007843A1 true WO1993007843A1 (fr) 1993-04-29

Family

ID=3775766

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1992/000558 WO1993007843A1 (fr) 1991-10-22 1992-10-19 Pansement

Country Status (1)

Country Link
WO (1) WO1993007843A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997033643A1 (fr) * 1996-03-14 1997-09-18 O'neil, Christine Appareil et procede de mise en place d'un catheter
WO1999000080A1 (fr) * 1997-06-25 1999-01-07 Paul Hartmann Ag Emplatre
WO2012161897A3 (fr) * 2011-05-26 2013-03-14 Carefusion 2200, Inc. Système de pansement
WO2017058079A1 (fr) * 2015-09-30 2017-04-06 Vigmed Ab Dispositif de protection de pointe d'aiguille et système de fixation

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1425338A (en) * 1973-08-20 1976-02-18 Mpl Inc Attachable needle assembly

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1425338A (en) * 1973-08-20 1976-02-18 Mpl Inc Attachable needle assembly

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997033643A1 (fr) * 1996-03-14 1997-09-18 O'neil, Christine Appareil et procede de mise en place d'un catheter
WO1999000080A1 (fr) * 1997-06-25 1999-01-07 Paul Hartmann Ag Emplatre
US6242665B1 (en) 1997-06-25 2001-06-05 Paul Hartmann Ag Bandage
WO2012161897A3 (fr) * 2011-05-26 2013-03-14 Carefusion 2200, Inc. Système de pansement
WO2017058079A1 (fr) * 2015-09-30 2017-04-06 Vigmed Ab Dispositif de protection de pointe d'aiguille et système de fixation

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