WO2012168266A1

WO2012168266A1 - Sterile protector

Info

Publication number: WO2012168266A1
Application number: PCT/EP2012/060638
Authority: WO
Inventors: Oliver GÖDJE
Original assignee: Pulsion Medical Systems Se
Priority date: 2011-06-07
Filing date: 2012-06-06
Publication date: 2012-12-13
Also published as: DE202011101529U1

Abstract

The invention relates to a sterile protector, which has a catheter with at least one probe lumen (4) and with an associated probe port (5) for insertion of a probe into the probe lumen (4). The probe port (5) of the probe lumen (4) to be used is located in the area of the circular local weakening of the film (6). The preferably transparent film (6) permits excellent monitoring of the position of other cables and lines leading to the patient or away from the patient. Through the outlet opening (10) created along the perforated line (9) after the protector has been torn open by means of a tab (11) serving as a tearing aid, the probe port (5) can be easily drawn onto the second side (8) of the film (6), and the closure piece of the probe port (5) can be removed before the insertion of the probe.

Description

STERILE PROTECTION ORDER

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 coverage of the puncture site with a perforated cloth when laying central venous catheters (CVC), which leaves the point to be punctured in as narrow a range as possible. If a Seidinger (Guidewire) introducer technique is used, it is recommended that an additional sterile drape be placed in the area near the coronary artery, as the use of a perforated drape alone creates a risk of contamination of the wire. Also in the further use of CVC, eg in the context of an intensive care treatment, the careful adherence to hygiene regulations is suggested ("Kathetherpflege".) There is also an increased need for sterile work for multi-lumen CVS (multivolume CVC), since this overall However, multilevel CVCs are particularly suitable for intensive care applications as they allow easy access to the patient for therapeutic and diagnostic purposes.Using multilevel 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 lumina and blood samples for blood gas analysis or hematological and biochemical examinations are taken in. In particular, metrological, eg fiber optic, probes can be introduced via a probe lumen, for example For example, to measure 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 can be adhered to the appropriate area to be treated because they consist of an adhesive coated transparent film and a non-transparent edge. Document 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 document EP 1440667 B1 discloses a small dimensioned surgical drape for covering wounds and for fixing objects in the area close to the wound, consisting of a flexible, adhesive plastic film which contains an opening which 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 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.

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 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 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.

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 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.

In a preferred embodiment of the sterile protection arrangement, the film is designed to be sterile not only on its first (lower) but also on its second (upper) side. Such a trained film can be advantageously used on both sides and / or offers even with one-sided use excellent hygienic protection. Advantageously, the film may also be provided with a suitable fastening aid, e.g. 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 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.

In a preferred embodiment of the sterile protection arrangement, 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).

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 localized weakening of the film by a correspondingly affixed (for example printed) marking on the film is recognizable to the user.

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 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).

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 the storage of the proximal probe part in the pocket, the manipulation of the probe be carried out efficiently and safely 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.

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.

Detailed description of preferred embodiments

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. In this case, 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. When executed by a person, the previously removed from the packaging, lying on the preferably sterile trained second side 8 of the film 6, sterile probe 3 can now be easily inserted into the open probe port 5. 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 side 8 of the film 6 be advantageous. After completion of the measure, 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. Here, 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. When placing the probe 3, however, 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.

Claims

claims

1. 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.

2. Sterile protection arrangement according to claim 1, wherein the film has a local weakening in the region of the probe port.

3. Sterile protection arrangement according to claim 2, wherein the local weakening has a weakening or perforation line.

4. Sterile protection arrangement according to any one of the preceding claims, wherein the film 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.

6. Sterile protection arrangement according to claim 2, wherein the local weakening has a puncture surface formed by locally weaker material.

7. Sterile protection arrangement according to one of the preceding claims, wherein the film has a Aufreißhilfe 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.

9. sterile protection arrangement according to one of the preceding claims, wherein the film is sterile on both sides.

10. Sterile protection arrangement according to one of the preceding claims, wherein the film is additionally provided with at least one pocket.