Sterile cover for surgical fields, and use thereof

Abstract

The invention relates to a sterile cover (3) for surgical fields, the sterile cover comprising a first covering layer (1) for externally covering the surgical field of a patient, wherein the first covering layer (1) has a coupling device (4) on the side facing away from the patient, and the coupling device (4) is designed to have an auxiliary device (6) fastened thereto. A second covering layer (2) is fastened along a contact region (7) on the side (1A) of the first covering layer (1) facing away from the patient and is sterile at least on the side (2A) thereof facing away from the first covering layer (1). When in the use state, the second covering layer (2) covers the coupling device (4) or an auxiliary device (6) fastened to the first covering layer (1) by means of the coupling device (4).

Description

[0001] Sterile drapes for surgical fields and their use

[0002] The invention relates to a sterile drape for surgical fields according to the preamble of the main claim. Furthermore, its use and a set comprising the sterile drape are also objects of the invention.

[0003] Modern surgical techniques increasingly allow for minimally invasive procedures. The small incisions and openings required support a rapid recovery after medical intervention. However, it remains essential that the incisions and the surrounding skin surface are kept sterile and do not come into contact with non-sterile objects.

[0004] Medical personnel wear sterile clothing during a procedure. To position additional necessary aids such as measuring devices, coils, needle holders, telemanipulators, robotic devices, and monitoring equipment on the patient, a patient drape (first layer), for example, a surgical fenestrated drape, can be equipped with a suitable adapter (e.g., US 7,699,885 B2, DE 102022 125038 A1). Another solution is known from EP 3291 757 B1. There, a sterile needle is enclosed in a sheath. The needle is manipulated through the sheath using a manipulator that is otherwise freely accessible.

[0005] In prior art solutions, parts of the auxiliary devices always remain outside the sterile environment of the surgical field, but within, for example, the operating room. To prevent contamination, at least the corresponding exposed parts of the auxiliary devices must undergo complex sterilization procedures. The invention aims to reduce the disadvantages of the prior art and, in particular, to propose a solution that reduces the risk of contamination emanating from auxiliary devices.

[0006] The problem is solved with a sterile drape according to the main claim. A set and a use are the subject of the dependent claims. Advantageous embodiments are specified in the dependent claims.

[0007] A sterile drape for surgical fields according to the invention comprises a first covering layer for the outer covering of a patient's surgical field. The first covering layer has a coupling device on its side facing away from the patient. The coupling device serves to attach an auxiliary device and is designed accordingly, for example, with regard to its geometry and choice of material. Adjacent to the coupling device, the sterile drape may have an opening. The opening may be closed with an incision film.

[0008] According to the invention, a second covering layer is provided, which is attached to the patient-facing side of the first covering layer along a contact area.

[0009] The second drape layer is stored in a folded, inverted, or rolled state. In this state, the sterile drape can be placed on the patient and any necessary auxiliary device attached. The drape can then be prepared for use by unfolding, unfolding, or unrolling the second drape layer and using it to cover the auxiliary device. Storing the drape in a folded, inverted, or rolled state prevents contamination of the second drape layer until it is needed.

[0010] The second cover layer is unfolded, unfolded, or unrolled starting from the contact area. The contact area can be located, for example, next to the coupling device on the side of the cover facing away from the patient.

[0011] The contact area extends over the coupling device, and the second cover is therefore at least partially attached to the coupling device. It can be unfolded, unfolded, or unrolled starting from the contact area.

[0012] The upper side of the second cover layer, facing away from the first, is sterile. In its operating state, the second cover layer conceals the coupling device or an auxiliary device attached to the first cover layer by means of the coupling device. The operating state refers to the relative positioning of the first and second cover layers during normal use of the sterile cover.

[0013] The upper surface of the second covering layer is directly accessible from the environment, particularly from the operating room. Due to its sterility, contact between medical personnel and the upper surface of the second covering layer is hygienically negligible. To solve the problem of the invention, the second covering layer is designed, in its operational state, to enclose the coupling device or an auxiliary device attached to the coupling device and the first covering layer. The term "enclosing" refers to a tight seal of the coupling device or the auxiliary device against the environment, particularly the operating room. The side of the auxiliary device and / or the coupling device facing the first covering layer is typically not covered by the second covering layer. Its seal against the environment is provided by the underlying first covering layer.

[0014] The term "enclosure" includes the optional presence of a cable connection between the coupling device or auxiliary device and another component, for example, for power supply or data transmission. This component can be located next to, above, or below a patient's body in the operating room and is itself not covered by the sterile drape or any of its components. The cable connection can be completely or partially concealed by the second cover layer. In particular, it is intended that the cable connection can run freely to the component. Designs in which the power supply to the auxiliary device is ensured by an energy storage device integrated into the coupling device or the auxiliary device itself are advantageous.Data transmission, where provided for, can also be advantageously carried out wirelessly, for example via radio or using a local network, for example via Bluetooth or similar technologies.

[0015] Optionally, the coupling device can provide a passage, preferably arranged centrally. This passage can preferably be located above an opening in the first cover film.

[0016] The opening can in turn be closed with a film (incision film) which is opened when the sterile drape is used.

[0017] For example, the second cover layer can be folded into the opening of the coupling device, which is arranged particularly centrally in an annular, oval, round, polygonal, or otherwise shaped, and attached at its edges, i.e., in particular along a contact strip surrounding the opening of the first cover layer. Preferably, the auxiliary device also has an annular, oval, round, polygonal, or otherwise shaped opening. In this case, the second cover layer can be unfolded through the opening of the auxiliary device attached to the coupling device and cover the areas of the auxiliary device located laterally to the opening.

[0018] With such a design, for example, access to the patient and the surgical field can still be maintained.

[0019] The materials used for the first and second covering layers can be any substances, composites, and films known from the prior art, provided they meet the requirements for necessary sterility and handling. The first covering layer can be transparent or semi-transparent to visible light. The first covering layer can be provided with adhesive strips or patches on its sterile side facing the patient, allowing it to be fixed to the patient's body.

[0020] To ensure that the second covering layer remains securely in position during use, the side of the second covering layer facing the first can advantageously form a releasable, adhesive bond with it, at least in sections, upon contact. An adhesive bond means that the second covering layer does not simply rest on top, but is held in place, for example, by adhesive or cohesive interactions with the surface of the first covering layer. For this purpose, the first covering layer can be provided with adhesive strips or pads on its side facing away from the patient. Additionally or alternatively, the second covering layer can also be provided with adhesive strips or pads on its side facing the first covering layer.

[0021] The second covering layer can also be transparent or semi-transparent to visible light, i.e., formed by a transparent or semi-transparent layer, in particular a transparent film. Advantageously, the auxiliary device can thus be more easily observed and / or manipulated through the second covering layer.

[0022] In order to remain sterile until use and to be stored and kept without additional effort, the sterile cover according to the invention is advantageously provided as a set in sterile packaging.

[0023] The sterile drape according to the invention can be used in both human and veterinary medicine. It is used in surgical or diagnostic procedures, in particular for covering an operating field and for applying an auxiliary device.

[0024] The invention is explained in more detail below with reference to exemplary embodiments and illustrations. These show:

[0025] Fig. 1 shows a schematic representation of an embodiment of the sterile cover according to the invention with a folded-in second cover layer;

[0026] Fig. 2 shows a schematic representation of the embodiment of the sterile cover according to the invention with coupled auxiliary device; and

[0027] Fig. 3 shows a schematic representation of the embodiment of the sterile cover according to the invention in its state of use with the second cover layer unfolded.

[0028] The essential elements of a sterile drape 3 according to a first embodiment of the invention are a first covering layer 1, a second covering layer 2, and a coupling device 4. In the embodiment shown in Fig. 1, the first covering layer 1 is designed as a surgical drape with a circular opening 5. In the embodiment shown in Fig. 1, the opening 5 is closed with an incision film 8 (shown in Fig. 1 with a grid pattern). However, the incision film 8 is optional and can be omitted in other embodiments of the sterile drape 3. The incision film 8 can be removed or opened when using the sterile drape 3. After removal or opening of the incision film 8, access to a surgical field on a patient (not shown) is provided through the opening 5. The coupling device 4 is arranged in a ring around the opening 5 and encompasses it laterally.The coupling device 4 serves to connect auxiliary devices 6 (see Figs. 2 and 3). In Figure 1, the second cover layer 2 (shown with a dotted area) is attached around the opening 5 along a contact area 7 on the side facing away from the patient, either to the first cover layer 1 or to the coupling device 4, and is folded into the coupling device 4 and is therefore only visible as a narrow ring. In the example of Fig. 1, the contact area is a contact track 7 that surrounds the opening 5. Along this contact track 7, the second cover layer 2 is welded to the first cover layer 1.

[0029] The sterile drape 3 of Fig. 1 can be placed over the surgical field on the patient so that the surgical field lies below the opening 5.

[0030] In a further step when using the sterile cover 3 according to the invention, an auxiliary device 6 can be attached to the coupling device 4 (Fig. 2). In the example shown, the auxiliary device 6 is a schematically represented MRI receiver coil (magnetic resonance imaging). This coil has a free passage in its center and, when mounted, surrounds the opening 5. In the example of Fig. 2, the coupling device 4 is concealed by the receiver coil 6 mounted on it.

[0031] To establish the sterile state of the drape 3, the second covering layer 2 is unfolded from the coupling device 4 and over the auxiliary device 6, as illustrated by the arrows in Fig. 3. The fully unfolded second covering layer 2 now covers the auxiliary device 6 and lies flat at its edges on the side 1A of the first covering layer 1 facing away from the patient (and towards the viewer). Due to adhesive effects between the materials of the first and second covering layers 1, 2, the second covering layer 2 adheres to the first covering layer 1. The side 2A of the second covering layer 2 facing away from the first covering layer 1 is sterile, so there is no risk of contamination from the auxiliary device 6, which is not necessarily sterile.

[0032] 1 first covering layer

[0033] 1 A patient-facing side of the first covering layer

[0034] 2 second cover layer

[0035] 2A Side of the second covering layer facing away from the first covering layer 3 Sterile covering

[0036] 4 coupling device

[0037] 5 Opening

[0038] 6 Auxiliary device

[0039] 7 Contact area

[0040] 8 Incision film

Claims

Patent claims 1. Sterile drape (3) for surgical fields, comprising a first covering layer (1 ) for the outer covering of the surgical field of a patient, wherein the first covering layer (1) has a coupling device (4) on its side (1A) facing away from the patient, and the coupling device (4) is designed to allow an auxiliary device (6) to be attached to it; characterized by the fact that a second cover layer (2) is attached to the side (1 A) of the first cover layer (1 ) facing away from the patient along a contact area (7); the side (2A) of the second cover layer (2) facing away from the first cover layer (1) is sterile; the second cover layer (2) in the state of use covers the coupling device (4) or an auxiliary device (6) attached to the first cover layer (1) by means of the coupling device (4); the second cover layer (2) is held in a folded, folded, or rolled state and, in the state of use, can be used in an unfolded or unrolled state to cover the auxiliary device (6); the second cover layer (2) can be unfolded or unrolled starting from the contact area (7); and the contact area (7) extends over the coupling device (4) and the second cover layer (2) can be unfolded or unrolled starting from the contact area (7).

2. Sterile covering (3) according to claim 1, characterized in that the side of the second covering layer (2) facing the first covering layer (1) forms a detachable, adhesive bond with the first covering layer (1) at least section by section.

3. Sterile cover (3) according to one of claims 1 or 2, characterized in that the second cover layer (2) is designed as a transparent or semi-transparent layer.

74. Sterile cover (3) according to one of the preceding claims, characterized in that the first cover layer (1) has an opening (5) in the area of ​​the coupling device (4).

5. Sterile cover (3) according to claim 4, characterized in that the contact area (7) is formed by a contact track encompassing the opening (5).

6. Sterile cover (3) according to claim 4 or 5, characterized in that the coupling device (4) has a centrally arranged passage which is arranged above the opening (5).

7. Sterile cover (3) according to one of claims 4 to 6, characterized in that the opening (5) is closed with an incision film (8).

8. Set comprising a sterile cover (3) according to any of the preceding claims in a sterile package.

9. Use of a sterile drape (3) according to any one of claims 1 to 7 in a surgical or diagnostic procedure for covering an operating field and for applying an auxiliary device (6). 8

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