WO2012168266A1 - Ensemble de protection stérile - Google Patents

Ensemble de protection stérile Download PDF

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Publication number
WO2012168266A1
WO2012168266A1 PCT/EP2012/060638 EP2012060638W WO2012168266A1 WO 2012168266 A1 WO2012168266 A1 WO 2012168266A1 EP 2012060638 W EP2012060638 W EP 2012060638W WO 2012168266 A1 WO2012168266 A1 WO 2012168266A1
Authority
WO
WIPO (PCT)
Prior art keywords
film
probe
sterile
catheter
protection arrangement
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2012/060638
Other languages
German (de)
English (en)
Inventor
Oliver GÖDJE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pulsion Medical Systems SE
Original Assignee
Pulsion Medical Systems SE
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 Pulsion Medical Systems SE filed Critical Pulsion Medical Systems SE
Publication of WO2012168266A1 publication Critical patent/WO2012168266A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00902—Material properties transparent or translucent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/20—Surgical drapes specially adapted for patients
    • A61B46/23—Surgical drapes specially adapted for patients with means to retain or hold surgical implements
    • A61B2046/234—Surgical drapes specially adapted for patients with means to retain or hold surgical implements with means for retaining a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • 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
    • A61M2025/0246—Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means

Definitions

  • the present invention generally relates to a sterile protection assembly.
  • the invention relates to a sterile protection assembly for a central venous catheter system.
  • Vascular catheters central venous catheters, arterial catheters
  • urological catheters bladedders, ureters, nephrostomy catheters
  • peritoneal dialysis catheters e.g.
  • multilevel CVCs are particularly suitable for intensive care applications as they allow easy access to the patient for therapeutic and diagnostic purposes.
  • various parameters can be determined by means of suitable measurement technology, infusion solutions, blood and Blood derivatives as well as pharmaceuticals can be supplied via different lumina and blood samples for blood gas analysis or hematological and biochemical examinations are taken in.
  • metrological, eg fiber optic, probes can be introduced via a probe lumen, for example, to measure central venous oxygen saturation (Scv02).
  • a probe lumen for example, to measure central venous oxygen saturation (Scv02).
  • Sav02 central venous oxygen saturation
  • the perforated cloth offers the advantage of sterile cover ZVK-distant areas.
  • the advantage of this type of cover when performing procedures on the catheter is its slip resistance: the cover can be adhered to the area to be treated with the opening placed over the catheter.
  • a major disadvantage, however, is the relatively complex preparation before the actual handling of the catheter: the film must be glued to a correspondingly large area on the patient, which must be previously exposed and disinfected, the bonding with the corresponding (probe) ports of the Catheter must be avoided. After the therapeutic or diagnostic action on the catheter, the foil must be removed without dislodging the catheter or other patient or patient cable, infusion tubing, etc. Especially with multi-lumen catheters or a variety of running in the work area lines and cables are difficult to remove glued films. Overall, a use of this type of cover when using the ZVK would be very expensive.
  • the present invention therefore has for its object to provide a device which helps to overcome the disadvantages mentioned.
  • the invention thus relates to a sterile protection arrangement which has a catheter with at least one probe lumen and associated probe port for insertion of a probe into the probe lumen.
  • the catheter in the region of the probe port, the catheter has a transparent foil which is spread over an area of at least 100 square centimeters and whose at least side facing the catheter is sterile.
  • the transparent film is formed in the region of the probe port to allow the passage of a probe through the film.
  • catheter preferably refers to vascularly located catheters having a predominantly longer residence time, for example arterial catheters or central venous catheters, but in principle the sterile protection arrangement according to the invention is also suitable for all other types of applications in which handling of catheters under sterile conditions is required. For example, in the use of peridural catheters in the context of pain therapy or in the manipulation of supravesical localized indwelling catheters in urology.
  • the film may be limited to a spread area of less than 900 square centimeters. This size of the film is particularly advantageous for use in a spatially delimited area on the patient, for example, when inserting a probe into a central venous catheter located in the neck region. On the one hand, such a sufficiently large area can be covered in order to reduce the risk of contamination of the tip of the probe and the probe port, on the other hand is avoided by the comparison of conventional surgical cover films small size of the film dislocation of adjacent cables and lines. In an alternative advantageous embodiment, the film may be spreadable over an area of at least 2500 square centimeters.
  • Such a trained film offers the advantage of a sufficiently large, sterile storage area for probes or corresponding devices, in particular if necessary, to be carried out in a single operation, diagnostic or therapeutic interventions. Furthermore, in the case of multi-lumen catheters, a plurality of ports can be hygienically placed spatially separated from one another on the larger contact surface of the foil designed in this way.
  • the film is designed to be sterile not only on its first (lower) but also on its second (upper) side.
  • a trained film can be advantageously used on both sides and / or offers even with one-sided use excellent hygienic protection.
  • the film may also be provided with a suitable fastening aid, e.g. a single- or double-sided pressure-sensitive adhesive tape, be formed.
  • a suitable fastening aid e.g. a single- or double-sided pressure-sensitive adhesive tape
  • the size range and the geometric nature of the local weakening can be configured according to different application requirements.
  • the local weakening can have a weakening line, in particular a punched-on. It will be one below understood (in particular by punching) produced local weakening, which does not completely cut through the film material, but locally reduces the material thickness so that there is a defined tear line at local mechanical stress.
  • the local weakening may have a perforation. This is understood to mean an incomplete separation of the film in which severed and non-severed regions of the film alternate along a perforation line (for example produced by punching).
  • the film may be weakened not only along a line but over a flat area intended for the passage of the probe in the sense of a puncture site.
  • the probe port lying under the film can simply be pushed through the intended area and placed on the second side of the film to introduce a probe.
  • An executed in this way sterile protection arrangement has the advantage that the thus generated outlet opening for the probe port largely corresponds to the size of the probe port, so that the risk of contamination for the probe to be inserted, for example by touching the tip of the probe with skin areas of the patient is very low.
  • the position of such localized weakening of the film by a correspondingly affixed (for example printed) marking on the film is recognizable to the user.
  • the region of the film produced by a weakening or perforation line can be removed by means of a tearing aid, e.g. As a tab or tear, are at least partially separated from the remaining part of the film or dissolved out of this, before the probe port is passed through the outlet opening thus produced.
  • a tearing aid e.g. As a tab or tear
  • the geometric configuration of the region of the film intended for the probe feed-through can be designed in accordance with the respective requirements and is fundamentally not subject to any particular restrictions with respect to its shape (for example, round, oval, angular, linear). Preferred are round to narrow elongated Embodiments that can form a sufficiently large passage opening for conventional probe ports.
  • a tear-open can be provided, which allows a tearing of the film along a distance defined by a dividing line from the region of the probe port to the film edge.
  • a tear-open aid designed in this way, after insertion of the probe into the probe lumen, the foil can be severed in a simple manner by pulling along a dividing line which is essentially predetermined by the pulling direction. The thus severed film can subsequently be excellently removed, without having to move or move other patient-leading or patient-coming cables and lines.
  • the dividing line can advantageously be formed in the form of a linear weakening or perforation of the film.
  • the film is preferably a polymer film selected from the group of synthetic and / or natural mono- or composite polymers or a material having comparable properties. It can be done by per se known measures such. Vorstreckung a highly directional mechanical behavior of the film can be achieved. A film formed in this way has anisotropic properties and a preferred direction of crack propagation, so that perforation or punching for defined tearing can be dispensed with. In the case of a film formed from such a material, it is advantageous if the tensile direction to be used is recognizable to the user, for example by means of arrow marks printed on the film.
  • the film may also be formed from a material that can be sterilized by conventional polymer film processes, which meets the requirements for surgical covers specified in EN 13795 (EU standard for surgical covers, gowns and clean air suits used as a medical device).
  • the sterile protection arrangement may additionally be formed with at least one pocket.
  • the bag may advantageously receive a sterile probe and the connecting leads connected thereto during the manipulation of the probe, for. B. when laying, the proximal part of the probe safe and free of contamination can store.
  • the stiffness of conventional probes occurring during handling movements of the proximal probe part by the person performing can be insufficiently controlled, so that usually a second person to secure the proximal probe part must be consulted.
  • the manipulation of the probe be carried out efficiently and safely by a person.
  • such storage prevents accidental slippage of the proximal probe portion in the storage of the film on an uneven surface, such.
  • the bag may advantageously be formed as an envelope on the edge of the film, wherein the film is preferably folded over at the parting line opposite edge and where the lateral film edges come to rest on itself, is welded to a bag.
  • the at least one pocket of the film may be attached, in particular welded or glued on.
  • FIG. 1 shows a schematic plan view of the sterile protection arrangement according to the invention.
  • Figure 2 shows a schematic plan view of the film with a representation of a punching formed around and extending to the edge of the film double dividing line.
  • Figure 3 shows the schematic plan view of a simpler, alternative embodiment of the film with a simple dividing line extending to the edge of the film.
  • Figure 4 shows a variant similar to Figure 1, but which is provided with a pocket.
  • FIG. 1 shows a sterile protection arrangement 1 which is suitable for inserting a probe 3 into a probe lumen 4 of a (localized, for example, in the internal jugular vein).
  • Catheter 2 The illustrated catheter 2 is formed with multiple lumens.
  • the probe port 5 of the probe lumen 4 to be used is located in the region of the locally formed local weakening of the foil 6, recognizable by the dashed line shown in phantom line 9.
  • the unused lumens of the catheter 2 remain on the catheter 2 facing first sterile side formed. 7 the slide 6, seen from the viewer's lower side.
  • Particularly preferred is a sterile training and the second side 8 of the film 6, wherein the second side 8 is seen from the viewer from the upper side of the film 6.
  • the position of other leading to the patient or coming from the patient cables and lines can be excellently controlled by the preferably transparently formed film 6.
  • the probe port 5 to be used lies below the local weakening of the film 6.
  • the probe port 5 is simply pulled onto the second side 8 of the film 6 by means of the exit opening 10 formed after tearing by means of a tab 11 along the punching line 9 (dashed line) and the closure of the probe port 5 (eg, a Luer lock) are removed prior to insertion of the probe.
  • the closure of the probe port 5 eg, a Luer lock
  • the film can be divided along the double dividing line 12 leading to the film edge 13 (dashed line) so that a simple removal can be carried out by a pulling and / or rotating movement without displacing adjacent lines and cables.
  • FIG. 2 shows the foil 6 used in the sterile protection arrangement 1 according to the invention in a plan view. Shown is the local weakening of the film 6 in a round embodiment. Because of the better representability here is the local weakening in the form of a perforation as a punching line 9 (dashed) shown.
  • the tearing aid 11 is preferably arranged so that after completion of the measure on the catheter 2, the film 6 along the dividing line 12 (dashed) can be separated easily and without displacement of the film 6 in the direction of the film edge 13, by continuing on the tear 11 pulls. The thus separated film 6 can be removed by a simple rotation and / or pulling movement.
  • Figure 3 shows a slightly simpler version of the film 6 without tab 11 and with only simple parting line 12.
  • the film 6 can be torn by touching it at locations of the film edge 13 left and right of the dividing line 12 and then in the direction of the printed arrows 14 pulls apart.
  • Fig. 4 shows a substantially formed as in Fig. 1 variant.
  • proximal parts of the probe 3 can be intermediately stored without contamination in a film envelope opposite the dividing line 12 and designed in the manner of a pocket 15.
  • the lateral edges of the film envelope are preferably welded.
  • One of the two welds 16 can also be omitted.
  • the opening of the pocket 15 faces the passage opening 10.

Landscapes

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

Abstract

L'invention concerne un ensemble de protection stérile comportant un cathéter doté d'au moins un lumen de sonde (4) et d'un orifice de sonde (5) associé destiné à introduire une sonde dans le lumen de sonde (4). L'orifice de sonde (5) du lumen de sonde (4) à utiliser se situe dans la zone de l'atténuation locale de configuration ronde du film (6). La position d'autres câbles et fils menant au patient ou partant du patient peut être contrôlée à merveille par le film (6) réalisé de préférence de manière transparente. L'ouverture de sortie (10) produite le long de la ligne de découpage (9) après déchirement au moyen d'une languette (11) servant d'aide au déchirement du bord permet de tirer facilement l'orifice de sonde (5) sur la deuxième face (8) du film (6) et de retirer la fermeture de l'orifice de sonde (5) avant l'introduction de la sonde.
PCT/EP2012/060638 2011-06-07 2012-06-06 Ensemble de protection stérile Ceased WO2012168266A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202011101529.0 2011-06-07
DE202011101529U DE202011101529U1 (de) 2011-06-07 2011-06-07 Sterilschutzanordnung

Publications (1)

Publication Number Publication Date
WO2012168266A1 true WO2012168266A1 (fr) 2012-12-13

Family

ID=44974278

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2012/060638 Ceased WO2012168266A1 (fr) 2011-06-07 2012-06-06 Ensemble de protection stérile

Country Status (2)

Country Link
DE (1) DE202011101529U1 (fr)
WO (1) WO2012168266A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202020102898U1 (de) 2020-05-20 2020-05-28 Viviane Wienholz Tragbare Halterung für extracorpurale Abschnitte von Katheterschläuchen und deren Verwendung

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5437622A (en) 1992-04-29 1995-08-01 Laboratoire Hydrex (Sa) Transparent adhesive dressing with reinforced starter cuts
US6966320B1 (en) * 2004-11-09 2005-11-22 Samentha Baynes Surgical covering assembly
EP1440667B1 (fr) 1997-09-12 2006-03-01 KCI Licensing, Inc. Champ opératoire
US20060207609A1 (en) * 2003-12-01 2006-09-21 Michael Gil Covering for an aseptic treatment site
DE102007022878A1 (de) * 2006-09-22 2008-04-10 Geuder Ag Operationstuch
US20100300459A1 (en) * 2009-05-26 2010-12-02 Lair Anthony C Drape and method of using same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5437622A (en) 1992-04-29 1995-08-01 Laboratoire Hydrex (Sa) Transparent adhesive dressing with reinforced starter cuts
EP1440667B1 (fr) 1997-09-12 2006-03-01 KCI Licensing, Inc. Champ opératoire
US20060207609A1 (en) * 2003-12-01 2006-09-21 Michael Gil Covering for an aseptic treatment site
US6966320B1 (en) * 2004-11-09 2005-11-22 Samentha Baynes Surgical covering assembly
DE102007022878A1 (de) * 2006-09-22 2008-04-10 Geuder Ag Operationstuch
US20100300459A1 (en) * 2009-05-26 2010-12-02 Lair Anthony C Drape and method of using same

Also Published As

Publication number Publication date
DE202011101529U1 (de) 2011-10-20

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