DE202011101529U1 - Sterile protection order - Google Patents

Abstract

Sterile protection arrangement, comprising - a catheter with at least one probe lumen and associated probe port for inserting a probe into the probe lumen, - a transparent film which can be spread over an area of at least 100 square centimeters, rests on the catheter in the region of the probe port and is adapted to it, enable the passage of a probe through the film, at least the side of the film facing the catheter being sterile.

Description

Technical area

The present invention generally relates to a sterile protection assembly. In particular, the invention relates to a sterile protection assembly for a central venous catheter system.

State of the art

Various types of catheters are known in the art, e.g. Vascular catheters (central venous catheters, arterial catheters), but also urological catheters (bladders, ureters, nephrostomy catheters) or peritoneal dialysis catheters.

Although different requirements apply to the hygienic conditions when placing the catheter for the various fields of application, in particular for vascular catheters increased precautionary measures are taken to avoid catheter-associated infections. The German Society for Hospital Hygiene (DGKH) generally recommends the sterile cover of the puncture site with a perforated cloth when laying central venous catheters (CVC), which leaves the staging to be punctured in as narrow a range as possible. When using a Seldinger (with guidewire) insertion technique, it is recommended that an additional sterile drape be placed in the area near the puncture, as the use of a perforated drape alone creates the risk of contamination of the wire. Also in the further use of the ZVK, z. As part of an intensive care treatment, the careful adherence to hygiene regulations is suggested ("Kathetherpflege"). There is also an increased need for sterile work for multivolume CVT (multi-lumen CVC), as these have an overall higher complication rate with regard to catheter-associated infections. However, multilumen CVCs are particularly suitable for intensive care applications because they allow easy access to the patient for therapeutic and diagnostic purposes. Using multi-lumen CVC, 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 lumens and blood samples taken for blood gas analysis or hematological and biochemical examinations. In particular, metrological, z. As fiber optic probes are introduced via a probe lumen, for example, to measure the central venous oxygen saturation (Scv02).

When inserting probes in multi-lumen CVC, mostly disposable perforated drapes are used, which are loosely placed on the puncture area after the corresponding surface disinfection and which can easily slip. The perforated cloth offers the advantage of sterile cover ZVK-distant areas. However, there is an even higher risk of contamination of the catheter-near puncture region as well as the probe and especially the probe tip (especially when using long probes), the larger the diameter of the hole recess in the cover is selected.

Conventional surgical drapes may be adhered to the appropriate area to be treated because they consist of an adhesive coated transparent film and a non-transparent edge. The publication US 5,437,622 discloses a surgical drape with facilitated handling of the adhesive, flexible plastic film. This consists of a composite of three materials, wherein the first material consists of a transparent, coated on one side with adhesive plastic film, which in turn is protected by a layer of releasably coated paper. The other surface of the adhesive-coated film is reinforced with a reinforcing layer of a less flexible plastic film intended to facilitate handling of the flexible, adhesive plastic film after the protective release layer has been peeled off. The drape contains no openings; these are cut into the appropriate area by the surgeon. The publication EP 1440667 B1 discloses a small sized surgical drape for covering wounds and securing articles in the wound-proximate area, consisting of a flexible, adhesive plastic film containing an opening that can be closed with a peelable film.

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 cables and cables bonded films are difficult to remove. Overall, a use of this type of cover when using the ZVK would be very expensive.

Presentation of the invention, object, solution, advantages

Starting from the aforementioned devices of the prior art, the present invention therefore has for its object to provide a device which helps to overcome the disadvantages mentioned.

This object is achieved by providing a sterile protection arrangement according to protection claim 1.

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. In the sterile protection arrangement according to the invention, 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. This sterile protection assembly, specially designed to meet the requirements of catheterized procedures, can excellently facilitate rapid and hygienic handling of the catheter, thus reducing the risk of catheter-associated infections.

The term "catheter" preferably denotes vascularly localized catheters with a predominantly longer residence time, for example arterial catheters or central venous catheters. In principle, however, the sterile protection arrangement according to the invention is also suitable for all other types of applications in which a handling of catheters under sterile conditions is required, for. As in the use of peridural catheters as part of a pain therapy or in the manipulation of supravesical localized indwelling catheters in urology.

In the dependent claims advantageous developments of the invention are given.

Advantageously, the continuous transparent design of the film, as all work areas remain visible during handling of the catheter and the risk of unintentional manipulation of other leading to the patient or coming from the patient cables and lines can be avoided.

The film may be limited to a spread area of less than 900 square centimeters. This size of film is particularly advantageous for use in a confined area on the patient, for example, when inserting a probe into a central venous catheter located in the cervical 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 on the larger contact surface of the folio configured in this way.

In a preferred embodiment of the sterile protection arrangement, the folio is designed to be sterile not only on its first (lower), but also on its second (upper) side. Such a trained Folio can be used advantageously on both sides and / or offers even with one-sided use excellent hygienic protection. Advantageously, the film can also with a suitable mounting aid, for. B. a single- or double-sided pressure-sensitive adhesive tape, be formed. Such a formed film can prevent slippage of the film during use or can be advantageously used in therapeutic or diagnostic interventions on the non-recumbent patient.

The size range and the geometric nature of the local weakening can be configured according to different application requirements. In a preferred embodiment of the sterile protection arrangement, the local weakening can have a weakening line, in particular a punched-on. It is understood to mean a local weakening (in particular by punching) which does not cut through the film material completely, but locally reduces its material thickness such that a defined tear line results under local mechanical stress.

In a preferred embodiment of the sterile protection arrangement, the local weakening may have a perforation. This is understood to mean an incomplete transection of the film, in which intersects along a perforation line (eg produced by punching) and alternates non-severed regions of the film.

In an alternative embodiment, 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. Thus, 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. Advantageously, the position of such a localized weakening of the film by a correspondingly mounted on the film (eg., Printed) marking for the user is recognizable.

In a further preferred embodiment, 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 sterile protection arrangement designed in this way offers the advantage that the probe port can be pushed through the outlet opening quickly and with only little effort.

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.

Advantageously, 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. By means of 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. In this case, the dividing line can advantageously be designed in the form of a linear weakening or perforation of the folio.

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 by known per se measures such. B. Vorstreckung a highly directional mechanical behavior of the film can be achieved. Such a Folio has anisotropic properties and a preferred crack propagation direction, so that can be dispensed with perforation or punching for defined tearing. 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 further be formed from a material sterilizable by the conventional methods for polymer films, which has the properties described in U.S. Pat EN 13795 (EU standard for surgical drapes, sheaths and Clean Air Suits, used as a medical device) specified requirements for surgical drapes met.

In a further preferred embodiment, 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. In particular, because of 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. By storing the proximal probe portion in the pocket, manipulation of the probe can be efficiently and safely performed by a person. In addition, such storage prevents accidental slippage of the proximal probe portion in the storage of the film on an uneven surface, such. B. the thorax region of a recumbent patient. 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. Alternatively, the at least one pocket of the film may be attached, in particular welded or glued on.

Unless otherwise indicated, features of various embodiments can be combined with each other and with per se known from the prior art features.

Brief description of the figures

Hereinafter, by way of example and not limitation, certain particular embodiments of the invention will be described with reference to the accompanying drawings. The representations are schematic and not to scale.

1 shows a schematic plan view of the sterile protection arrangement according to the invention.

2 shows a schematic plan view of the film with representation of a punching formed around and extending to the edge of the film double dividing line.

3 shows the schematic plan view of a simpler, alternative embodiment of the film with simple to the edge of the film extending dividing line.

4 shows a variant similar 1 , which is however provided with a bag.

Detailed description of preferred embodiments

1 shows a sterile protection arrangement 1 , which is suitable for introducing a probe 3 in a probe lumen 4 of a catheter (located, for example, in the internal jugular vein) 2 , The illustrated catheter 2 is designed with several lumens. This is the probe port 5 of the probe lumen to be used 4 in the area of the locally formed local weakening of the film 6 , recognizable by the punched line shown in dashed lines 9 , The unused lumens of the catheter 2 remain on the catheter 2 facing first, sterile trained side 7 the foil 6 , seen from the viewer's lower side. Particularly preferred is a sterile training and the second side 8th the foil 6 , the second page 8th the viewer sees the upper side of the film 6 is. The location of other leading to the patient or coming from the patient cables and wires can through the preferably transparent formed film 6 be controlled excellently. The probe port to use 5 lies below the local weakening of the film 6 , By after tearing by means of a tab serving as a tear 11 along the punching line 9 (dashed) resulting outlet 10 can the probe port 5 just to the second page 8th the foil 6 pulled and the lock of the probe port 5 (For example, a Luerlock) are removed before inserting the probe. When executed by a person, the previously removed from the packaging, on the preferably sterile trained second page 8th the foil 6 lying, sterile probe 3 Now just open the probe port 5 be introduced. In particular, in situations where only one person is performing the procedures on the catheter or in multiple therapeutic and / or diagnostic manipulations in a single operation, the use of a film which is spread on an area of at least 2500 square centimeters, because of the overall larger storage area for items and devices on the sterile second page 8th the foil 6 be beneficial. The film can after completion of the measure along the edge of the film 13 leading double dividing line 12 (dashed) be divided so that a simple removal by a pulling and / or rotating movement can be made without moving adjacent wires and cables.

2 shows the in the inventive sterile protection arrangement 1 used foil 6 in a top 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 break-in aid 11 is preferably arranged so that after completion of the procedure on the catheter 2 the foil 6 along the dividing line 12 (dashed) easy and without shifting the film 6 in the direction of the film edge 13 can be separated by continuing at the breakaway 11 draws. The so separated foil 6 can be removed by a simple twisting and / or pulling movement.

3 shows a slightly simpler version of the film 6 without flap 11 and with only a simple dividing line 12 , Here is the slide 6 be torn open by placing them in places of the film edge 13 left and right of the dividing line 12 touch and then in the direction of the printed arrows 14 pulls apart.

4 shows a substantially as in 1 trained variant. When laying the probe 3 However, here proximal parts of the probe can 3 in one of the dividing line 12 opposite, like a bag 15 trained foil envelope be stored without contamination. The lateral edges of the film envelope are preferably welded. One of the two welds 16 can also be omitted. The opening of the bag 15 is the passage opening 10 facing.

LIST OF REFERENCE NUMBERS

1

Sterile protection order

2

catheter

3

probe

4

probe lumen

5

port probe

6

foil

7

first page of the slide

8th

second side of the film

9

cut line

10

Through opening

11

tear open

12

parting line

13

film edge

14

printed arrows

15

bag

16

welds

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 5437622 [0005]
• EP 1440667 B1 [0005]

Cited non-patent literature

• EN 13795 [0021]

Claims (10)

Sterile protection arrangement comprising A catheter having at least one probe lumen and associated probe port for insertion of a probe into the probe lumen, A transparent foil which is spreadable over an area of at least 100 square centimeters, rests on the catheter in the area of the probe port and is adapted to allow the passage of a probe through the foil, wherein at least the catheter facing side of the film is sterile. Sterile protection arrangement according to claim 1, wherein the film has a local weakening in the region of the probe port. Sterile protection arrangement according to claim 2, wherein the local weakening has a weakening or perforation line. A sterile protection arrangement according to any one of the preceding claims, wherein the foil has a tearing aid for tearing in the region of local weakening. A sterile protection assembly according to any one of the preceding claims, wherein the foil has a tear-out aid for tearing a hole in the foil around the region of the probe port. Sterile protection arrangement according to claim 2, wherein the local weakening has a piercing surface formed by locally weaker material. A sterile protection assembly according to any one of the preceding claims, wherein the film has a tear aid for tearing the film over a distance from the region of the probe port to the film edge. A sterile protection assembly according to any one of the preceding claims, wherein the film is spreadable over an area of at least 2500 square centimeters. Sterile protection arrangement according to one of the preceding claims, wherein the film is sterile on both sides. Sterile protection arrangement according to one of the preceding claims, wherein the film is additionally provided with at least one pocket.

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