Surgical robot with cover fixing element, sterile cover film, cover fastening system, cover system and cover

The use of a cover fixing element for attaching sterile cover films to navigation markers on surgical robots addresses tracking inaccuracies and attachment complexities, ensuring accurate and cost-effective sterile coverage.

JP2025532210APending Publication Date: 2025-09-29B BRAUN NEW VENTURES GMBH
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Patent Information

Application Number
JP2025517801
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-29
Filing Date
2023-09-21
Publication Date
2025-09-29

AI Technical Summary

Technical Problem

Existing surgical robots face challenges with inaccurate tracking of navigation markers due to light reflection from sterile cover films, complex and non-standardized attachment methods, and increased costs from requiring sterile and non-sterile markers, as well as separate power means for LEDs.

Method used

A sterile cover film is fastened to navigation markers using a cover fixing element that creates a smooth surface, preventing light reflection and ensuring accurate tracking, with a snap or magnetic connection for easy and cost-effective attachment.

Benefits of technology

The solution provides reliable, standardized, and cost-effective attachment of sterile cover films to navigation markers, enhancing tracking accuracy while maintaining a sterile barrier without complex procedures or additional power requirements.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure relates to a medical cover fastening element (1) for releasably fastening a sterile cover film (2) to a navigation marker, preferably a light-emitting diode (101), more particularly to a light-emitting diode (101) of a surgical robot (102). The cover fastening element (1) has an opening (4) extending along a longitudinal axis (6) from a lower surface (8) to an upper surface (10), into which a protruding, particularly rotationally symmetrical, object, preferably a navigation marker, more preferably a light-emitting diode (101), can be inserted from the lower surface (8) toward the upper surface (10). The cover fastening element (1) further has a cover fastening interface (12) in the area of ​​the lower surface (8), through which the cover fastening element (1) is releasably fastened by pressure fastening and / or form-locking. The present invention also relates to a sterile cover film (2), a cover fastening system (50), a sterile cover system (52), and a surgical robot (102) according to the independent claims.
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Description

[Technical Field]

[0001] The present disclosure relates to a medical cover fastening element for releasably fastening (temporarily fastening) a sterile cover film / cover to a navigation marker, preferably a light-emitting diode as a navigation marker, in particular a light-emitting diode of a surgical robot. Furthermore, the present disclosure relates to a sterile cover film, a cover fastening system with navigation markers, in particular LEDs as navigation markers, and a cover fastening element, and further to a surgical robot equipped with a cover system and a cover according to the preamble of the independent claim. [Background technology]

[0002] To track the robot, it has multiple navigation markers, such as multiple (active or passive) light-emitting diodes (LEDs). However, the problem here is that the robot is not sterile, and for surgery a sterile barrier in the form of a radio-transparent, especially infrared-transparent, drape (cover film) must be inserted. In a particularly simple variant, a sterile transparent cover can be placed over the robot, completely covering it and thereby providing a sterile barrier to the surrounding environment.

[0003] However, research into accuracy has shown that the tracking accuracy of covered infrared LEDs is significantly reduced due to light reflection from the cover film. Therefore, accurate alignment of transparent sterile drapes is particularly important. Furthermore, securing the sterile drape safely and easily is a current issue.

[0004] Current prior art includes, for example, a navigated robotic arm equipped with a built-in laser for cutting bone structures. This bone-cutting robot also includes an LED covered by a drape, and the sterile drape (covering film) is attached to the surface of the robot by a shrinkable circumferential cord or strap. However, pre- or intra-operative attachment of the cord (i.e., before or during a surgical procedure) can be considered inappropriate because the draping and cord binding are complicated and there is no standardized procedure. Furthermore, the reflection of the cover light in the immediate vicinity of the LED can further reduce tracking accuracy due to the lack of a high-contrast background.

[0005] Furthermore, according to prior art documents, a microscope head tracking system has been implemented using passive tracking technology by attaching a black interface to a cover film (i.e., the sterile area) onto which passive markers can be attached. This configuration has a significant drawback: if a patient is admitted to the sterile area, the microscope head must also be tracked. Therefore, both sterile and non-sterile passive markers are required, which results in increased manufacturing and sterilization costs, as well as increased surgical costs. It also introduces new sources of error, such as the mistaking of sterile for non-sterile markers.

[0006] Another prior art document describes attaching a sterilized end effector containing an LED to a non-sterile robotic arm. This design has the disadvantage of requiring the sterilizable LED to be incorporated into the end effector, which increases costs. Furthermore, a means of powering the LED through a cover film must be provided separately. Another prior art document describes incorporating a fixing element to cover the LED into at least one of the links of the robotic arm. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, it is an object of the present disclosure to provide a cover fastening element, a sterile cover film (drape), a cover fastening system, a cover system, and a surgical robot that avoid or at least mitigate the drawbacks of the prior art and provide particularly easy and reliable fastening together with accurate tracking of navigation markers. A further secondary object is to provide fastening of the sterile cover film that is easy to handle and cost-effective. [Means for solving the problem]

[0008] The problem of the present disclosure is solved by the features of claim 1 for the medical cover fastening element, by the features of claim 9 for the surgical sterile cover film according to the invention, by the features of claim 10 for the cover fastening system according to the invention, by the features of claim 14 for the cover system according to the invention and by the features of claim 15 for the surgical robot according to the invention.

[0009] Thus, one of the basic concepts of the present disclosure is to use a sterile cover film to secure a navigation marker, particularly a robot's light-emitting diode, and the LED housing of each light-emitting diode in a removable manner for docking and undocking. For this purpose, a specially designed cover fixing element is used, which enables highly accurate tracking of the navigation marker, particularly a light-emitting diode (LED), especially an infrared LED. While the navigation marker, such as a light-emitting diode (LED), does not need to be sterile itself, a sterile cover film fastened via the connectable cover fixing element and tightly stretched over the navigation marker, particularly the light-emitting diode, creates a smooth surface for the cover film, preventing the sterile film from affecting tracking accuracy (by light reflection or diffraction). Therefore, the cover fixing element (particularly in combination with an LED or LED housing) can significantly improve the tracking accuracy of a navigation marker, particularly an LED, covered with a sterile drape or cover film, while also creating a smooth surface. The cover fixing element of the cover film tightly stretches the sterile cover film over the navigation marker, particularly the tracking LED, without destroying the sterile barrier. In this way, by using special cover fastening elements to correspondingly attach sterile cover films to navigational markers, particularly LEDs, of surgical robots, it is possible to provide a reliable and standardized sterile barrier in a simple, cost-effective, and fast manner. The navigational markers (e.g., LEDs) themselves (or within their housings) are securely integrated into (as or together with) a non-sterile robotic head, such as a microscope head or a non-sterile end effector, and are appropriately covered.

[0010] In other words, the technical design is based on a sterile cover film, such as an LED cover film, which can be fastened to a standardized interface, in particular a navigated sterile end effector (on or as a robot head), preferably a microscope head, via a special cover fastening element, either by snap connection or magnetic force. This standardized interface (for LED fastening) can also be the housing of a navigation marker, in particular the housing of a (tracking) LED. Furthermore, a snap lock or magnetic lock prevents unintentional loosening of the cover fastening element (such as the LED cover).

[0011] In yet another aspect, the present disclosure provides a medical cover fixing element for removably fixing a sterile cover film / drape to a navigation marker, in particular a light-emitting diode (LED), more particularly a light-emitting diode mounted on a surgical robot. The cover fixing element has an opening along a longitudinal axis extending from its underside to its upper side, into which a protruding, in particular rotationally symmetrical, object, preferably a navigation marker, more preferably a light-emitting diode having a housing, can be inserted in the upward direction. The cover fixing element also has a cover fixing interface, particularly in the area of ​​its underside, that is configured to be removably attached to the rotationally symmetrical protruding object, in particular a navigation marker, e.g., an LED, via the cover fixing interface by pressure fixation and / or form-fitting, and the cover fixing element is particularly configured to be in a sterile state or to be sterilizable.

[0012] The term lower surface means the surface of the cover fixation element facing the surface to which it is attached, such as the surface of a surgical robot or a navigation marker, whereas the upper surface of the cover fixation element is the surface that forms the free end side of the cover fixation element and is oriented outward towards the external environment.

[0013] The navigational markers are tracked by a navigation system and / or a tracking system (e.g., an optical tracking system) and used to identify at least one position of the navigational marker in space. In one embodiment, the navigational markers may be trackable LEDs.

[0014] Advantageous embodiments are set forth in the dependent claims and are particularly described below.

[0015] According to a preferred embodiment, the cover fastening element may be configured as a fastening clip with a snap connection as a cover fastening interface, with at least one, preferably multiple, locking fingers or clip arms extending downward in the direction of the longitudinal axis, the locking fingers or clip arms being radially resiliently deflectable for pressure-locking and / or form-locking retention of the cover fastening element, the locking fingers (16) preferably having radially inward and / or outward end locking projections (20) forming form-locking catches. The radially resilient locking fingers can be deflected radially outward to create a radially inward elastic preload, or vice versa. In this way, locking by frictional engagement (i.e., pressure-locking due to radial contact after resiliently deflecting the locking fingers) or form-locking due to the locking projections and locking catches.

[0016] According to a further embodiment, the cover fastening element can have locking fingers evenly distributed around the periphery of its opening, in particular arranged rotationally symmetrically, which locking fingers project towards the underside and ensure uniform circumferential fastening of the cover fastening element, the locking fingers themselves in particular forming the underside, i.e. the lower end. The locking fingers evenly distributed in the circumferential direction can thus be deflected radially and can fasten the cover fastening element, for example by a circumferential snap connection via the locking projections at their tips.

[0017] In particular, the cover fastening element may comprise, as cover fastening interface, at least one magnet for magnetic coupling in the area of ​​its underside, in particular an annular magnet arranged concentrically about the longitudinal axis, which magnet preferably forms at least part of the underside of the cover fastening element and is attached by pressure fastening to a complementary magnet or metallic surface, in such a way that the magnet is integrally fixed to the cover fastening element itself, thereby at least (magnetically) pressure fastening the cover fastening element.

[0018] In some embodiments, a magnet may be permanently integrated into the non-sterile end effector, particularly the microscope head, in a (separate) magnetic cover or LED cover. For example, a plastic cover cover with an embedded magnet fits over the LED, forming a detachable pressure-fit connection via magnetic force. This tensions the cover film and provides a smooth surface for optimal tracking of the LED.

[0019] In particular, the cover fixing element may consist of a thermoplastic material provided with an annular recess or groove into which a magnet can be inserted.

[0020] The magnet is arranged flatly without any particular steps and is surrounded only on the radially outer side in this embodiment, whereby the magnet is exposed as the underside of the cover fixing element.

[0021] Preferably, the cover fastening element can have at least one projection, particularly a circumferential projection extending radially outward, in its upper surface area to provide a catch for manual handling, so that the cover fastening element can be easily removed manually if necessary.

[0022] In particular, the cover fixing element may have a rotationally symmetrical shape and a conical shape along the longitudinal axis. In this case, the outer diameter of the upper surface may be larger than that of the lower surface to improve handling, and / or the inner diameter of the upper surface may be larger than that of the lower surface to ensure visibility of a navigation marker, such as a light-emitting diode. The conical outer surface (radial direction) of the cover fixing element forms a hook, thereby improving operability. Furthermore, if the inner radial surface is also conical in terms of the height of the LED's emitting surface, the funnel-shaped design increases the emitting area, improving the visibility of the LED's radiation when it is installed.

[0023] In particular, the cover fixing element may have a conical shape. The conical shape of the cover fixing element, in particular its cover fixing interface, reduces strain on the cover film and further facilitates the installation of the LED cover.

[0024] According to a further embodiment, the cover fixing element may have a radially inner, radially outward step towards the top surface along the longitudinal axis, which forms an annular offset in the top surface area at a position away from the longitudinal axis and increases the emission area, in particular for light-emitting diodes.The central part of the plate forms a portion corresponding to a radiation source (covered with a sterile cover film), and one of the surrounding walls of the radiation source is spaced apart, which makes it possible to increase the emission angle.

[0025] Preferably, the cover fastening element may have polyoxymethylene (POM: thermoplastic) as material or may be entirely made of said material.

[0026] In particular, the fastening of the sterile cover film can be carried out from the sterile side. For this purpose, the sterile cover fastening element can be fastened to the navigation marker, in particular the light-emitting diode, from the sterile side of the sterile cover film, for example by means of a snap connection or can be magnetically attached. In this configuration, for example, a standard cover film forming a sterile barrier can be placed over a surgical robot equipped with a navigation marker. In order to, on the one hand, reliably fasten the sterile cover film to the robot (to prevent it from falling off) and, on the other hand, ensure a clear surface on the navigation marker, the sterile cover film is attached to the navigation marker from the sterile side using the sterile cover fastening element. This allows for a simple and safe configuration.

[0027] Preferably, the cover fastening element may be dark-coloured, in particular black, in order to absorb as much reflected light as possible and also to increase the contrast with the navigation markers, in particular the light-emitting diodes.

[0028] In particular, the cover fixing element may have a surface colored or constructed in a dark color, especially black, which has the advantage of providing a high contrast with the infrared LED and improving visibility.

[0029] According to one embodiment, the cover securing element may be knurled on its radially outer periphery to facilitate manual handling, and more particularly, the cover securing element may include a plurality of circumferential wavy structures or recesses (grooves) spaced apart along its longitudinal axis.

[0030] In particular, the cover fixing element is configured as a snap connection, and the locking finger may have a locking protrusion facing radially outward, which is elastically pre-stressed radially inward and is configured to engage in an inner circumferential groove, in particular a circumferential groove, of the LED housing, in particular when attached to the LED.

[0031] In particular, the cover fixing element may be configured to have a rotationally symmetrical shape, which allows the user to position and fix the cover fixing element in any direction around the longitudinal axis without having to pay particular attention to the insertion direction of the cover fixing element.

[0032] Preferably, the cover fastening element may be formed with all edges rounded so as not to damage the cover film.

[0033] Furthermore, in particular in a longitudinal cross section along the longitudinal axis, the cover fastening element may have a concave cross-sectional shape or an L-shaped cross-sectional shape, which are examples of a rotationally symmetrical structure.

[0034] With regard to a sterile cover film that is removably attached to a navigation marker, in particular a light emitting diode, more particularly a light emitting diode of a surgical robot, the present disclosure solves the problem by fixedly, i.e. non-removably, attaching at least one cover fixing element to the sterile cover film, in particular to the upper surface of the cover fixing element, so that the sterile cover film sheet forms a sterile barrier against the outside.

[0035] In addition to systems in which the sterile cover film and the cover fixing element are separate, the sterile cover film of this embodiment has the cover fixing element integrated into the film itself at a predetermined position, thereby providing a sterile cover film that is specially adapted to cover, for example, robot bodies and navigation markers, in particular light-emitting diodes.

[0036] In one variant, a sterile cover film with an integrated magnetic cover fastening element can be securely attached to the inside of the sterile cover film. This bond can be achieved, in particular, by gluing, film welding or other bonding processes. The magnetic bond allows the cover film to be stretched over the LED and to accurately track the LED.

[0037] In embodiments of the integrated snap-fit ​​element and the integrated cover fixing element with a snap-fit ​​function, the cover fixing element may be integrated with a sterile cover film. The cover fixing element has a snap shape for attaching the cover fixing element and the sterile cover film to the LED fixing interface. In particular, by connecting the LED fixing interface and the cover fixing element, the cover film is stretched over the tracking LEDs.

[0038] The problem is solved by providing a cover fastening system comprising a navigation marker, particularly a light emitting diode, and a cover fastening element or a sterilizable cover film according to the present disclosure, wherein the navigation marker, particularly a light emitting diode, has an LED fastening interface, and the LED fastening interface and the cover fastening interface form a mutually compatible, mutually interacting, complementary coupling structure, whereby the cover fastening element is releasably fastened to the navigation marker, particularly the light emitting diode, by pressure fastening and / or form-fitting.

[0039] In particular, the LED and / or cover locking interfaces with catches allow for secure locking of the sterilizable cover locking element (e.g., LED cover) while still allowing for manual attachment and detachment of the cover locking element. That is, the cover locking element may be configured for temporary (secure) locking and can be manually removed again if necessary, while being designed to prevent unintentional release. In particular, the cover locking element may be configured to require a force above a predetermined threshold upon release to prevent unintentional release.

[0040] Furthermore, the cover fastening system may comprise a rotationally symmetrical funnel-shaped housing into which the housing of the light-emitting diode is adapted to be centrally inserted.

[0041] Preferably, the navigation marker, particularly the light-emitting diode, has an annular magnet as an LED fixing interface, which interacts with a magnet of opposite polarity, particularly an annular magnet, of the cover fixing interface to achieve pressure contact fixing with complementary polarity.

[0042] According to one embodiment, the navigation marker, in particular the light-emitting diode, may have a hollow cylindrical LED housing along the LED longitudinal axis, and as the LED fixing interface, a circumferential groove on the radially outer side of the LED housing, which forms a circumferential catch portion and engages with a radially elastic locking finger having a locking protrusion arranged radially inward of the cover fixing interface.

[0043] According to a further embodiment, the cover fixing element may be configured as a fixing clip having a snap connection as a cover fixing interface, and a circumferential gap is formed between the navigation marker, in particular the LED housing of the light-emitting diode, and the cover fixing element, the gap being sized to tightly accommodate a sterile cover film, in particular the gap width being set to correspond to the thickness of the cover film or slightly smaller (e.g., about 10% smaller), so that the cover film is geometrically engaged and clamped between the cover fixing element and the light-emitting diode.

[0044] The problem is solved with regard to the sterile cover system by the following configuration: a surgical robot having a robot arm connected to a robot base and a robot head (as or comprising an end effector) connected to the robot arm, the robot arm having at least one motor-driven robot arm link (or segment), in particular a plurality of actively drivable robot arm segments, and a plurality of navigation markers, in particular light-emitting diodes (LEDs), arranged on a surface of the robot arm segment and / or the robot head, each of the navigation markers, in particular LEDs, protruding at least partially from the surface, at least some, in particular all, of the navigation markers, in particular light-emitting diodes, include an LED fastening interface. The sterile cover system further comprises a surgical sterile cover film disposed over the navigational markers, particularly light emitting diodes, on the robotic arm segments and / or robotic head, and a plurality of cover fixation elements according to the present disclosure that interact with the sterile cover film and are configured to be removably coupled to the navigational markers, particularly light emitting diodes, via an LED fixation interface, each cover fixation element having an opening through which the navigational marker, particularly the light emitting diode, can be inserted, the cover fixation element having a cover fixation interface that is complementary to the LED fixation interface, and the cover fixation element interacts with the LED fixation interface to securely retain a portion of the surgical sterile cover film on the navigational marker, particularly the light emitting diode.

[0045] In particular, the sterile cover system may be provided in a sterile package as a set including a sterile cover film and a sterile cover fastening element.

[0046] In particular, the cover system may be configured such that the fastening or attachment by the cover fastening element is performed from the sterile side.

[0047] The problem is solved by a surgical robot for performing a surgical procedure on a patient, comprising: a robot arm connected to a robot base; and a robot head (as or comprising an end effector) connected to the robot arm, the robot arm having at least one motorized robot arm link or segment, in particular a plurality of actively drivable robot arm segments, and a plurality of navigational markers, in particular light emitting diodes (LEDs), arranged on a surface of the robot arm segment and / or the robot head, each of the navigational markers, in particular the light emitting diodes, protruding at least partially from the surface, at least some, in particular all, of the navigational markers, in particular the light emitting diodes, having a respective LED fastening interface, and the surgical robot comprising at least one cover fastening element, sterile cover film, cover fastening system, or sterile cover system according to the present disclosure.

[0048] In particular, the cover fixing element has a radially outward hook at its upper end (i.e., upper surface area), which is configured to be suitable for manual removal of the cover fixing element, making it easy for a user to grip and pull out the cover fixing element by hand. The cover fixing element may in particular have eight snap-connectable locking fingers / clip arms / locking arms.

[0049] Coloring the LED fixing interface and / or the cover fixing interface black can have the advantageous effect of increasing the contrast with the LED.

[0050] The method for producing a sterile cover film solves the above-mentioned problem by including the steps of placing a cover fixing element on the sterile cover film and joining the cover fixing element to the cover film, particularly by gluing or welding.

[0051] All disclosures regarding the cover fixing element according to the present disclosure are similarly applicable to the sterilization cover film, the cover fixing system, the cover system, and the surgical robot. [Brief explanation of the drawings]

[0052] The present disclosure is described in further detail below with reference to the accompanying drawings. [Figure 1] 1 is a perspective view of a preferred embodiment cover securing element for use in a preferred embodiment cover securing system of the present invention; FIG. [Figure 2] 2 is a longitudinal section through the cover securing system of FIG. 1 showing a transparent sterile cover film interposed between the light emitting diode (LED) and the cover securing element, but not yet attached. [Figure 3] 3 is a longitudinal cross-sectional view similar to FIG. 2 showing the cover securing element attached to the LED and the sterile cover film secured in place. [Figure 4] FIG. 4 is a perspective view showing the state of the cover fixing system shown in FIG. 3. [Figure 5] 1 is a perspective view of a surgical robot according to a preferred embodiment of the present disclosure, the surgical robot having the cover fastening system and cover fastening element shown in FIGS. 1 to 4. FIG. [Figure 6] 10 is a longitudinal section of a cover fastening system according to a further preferred embodiment, showing the cover fastening element with a magnet and not attached to an LED that includes a magnet; FIG. [Figure 7] 7 is a longitudinal cross-sectional view similar to FIG. 6 showing the cover securing element attached to the LED and secured with a sterile cover film. [Figure 8] FIG. 8 is a perspective view of the cover fastening system shown in FIG. 7. [Figure 9] FIG. 9 is a perspective view of the cover fixing element shown in FIGS. 6 to 8. [Figure 10]FIG. 10 is a partial perspective view of a surgical robot according to a further preferred embodiment, in which the robot head is fitted with a sterile cover film and a cover fixation element via an LED. [Figure 11] FIG. 10 is a partial perspective view of a sterile cover film sheet with an integrated cover fastening element according to another preferred embodiment. [Figure 12] 12 is a longitudinal cross-sectional view of a cover system according to a preferred embodiment, including a sterile cover film sheet having integrated therein the cover fastening element shown in FIG. 11. [Figure 13] 12, but showing the sterilization cover film fixed to the LED via a magnet. [Figure 14] FIG. 14 is a further perspective view of the system shown in FIGS. 11 to 13. [Figure 15] FIG. 14 is a further perspective view of the system shown in FIGS. 11 to 13. [Figure 16] 10A and 10B are perspective views of LEDs arranged protruding or recessed from a surface as docking areas for cover fastening elements according to further preferred embodiments; [Figure 17] 17A and 17B are longitudinal and perspective views of a cover locking element engaging with the docking area of ​​FIG. 16, the cover locking element having a radially outward locking projection; [Figure 18] 17A and 17B are longitudinal and perspective views of a cover locking element engaging with the docking area of ​​FIG. 16, the cover locking element having a radially outward locking projection; [Figure 19] FIG. 1 is a perspective view of a sterile cover film having an integrated cover fastening element with a snap-fit ​​connection. [Figure 20] FIG. 1 is a perspective view of a sterile cover film having an integrated cover fastening element with a snap-fit ​​connection.

[0053] These figures are diagrammatic and are intended to facilitate understanding of the invention, and identical elements are given identical reference numerals. Features of the respective embodiments are interchangeable. DETAILED DESCRIPTION OF THE INVENTION

[0054] 1-5 respectively show a cover fixation element, a cover fastening system, a cover system, and a surgical robot according to a first preferred embodiment of the present disclosure, which interact with each other or form subcomponents of each other.

[0055] Fig. 1 shows a perspective view of a medical cover fixing element 1 for removably fixing a sterile cover film 2 (see Fig. 2) to a light-emitting diode 101 as a navigation marker for a surgical robot 102 (see Fig. 5). As shown in Fig. 1, the cover fixing element 1 has a circular opening 4 in the center. The opening 4 extends along the longitudinal axis 6 between a lower surface 6 and an upper surface 10 of the cover fixing element 1.

[0056] A protruding light emitting diode 101 (with LED housing) can be inserted into this opening 4 along the longitudinal axis 6 from the lower surface 8 towards the upper surface 10 .

[0057] The cover fastening element 1 is sterile or made sterilizable for surgical use, and in particular can comprise a sterilizable material.

[0058] The cover fixing element 1 has a cover fixing interface 12 on or in the area of ​​its underside 8, via which the cover fixing element 1 can be releasably fixed both by pressure fixing and by form-fitting fixing, as will be described below.

[0059] Specifically, in this embodiment, the cover fastening interface 12 is designed as a snap connection 14, which has eight freely movable locking fingers 16 extending along the longitudinal axis towards the underside, and these locking fingers 16 are evenly distributed around the circumference.

[0060] The locking fingers 16 themselves form the underside 8 of the cover fastening element 1 and are arranged in a slightly conical, i.e. funnel-like, shape. As will be explained later, this facilitates handling and fastening by pushing. Furthermore, all of the locking fingers 16 are designed to have the same shape, tapering along the longitudinal axis 6 towards each locking tip 18. Furthermore, each locking tip 18 is formed with a locking projection 20 pointing radially inwards.

[0061] Near the top surface 10, a circumferential step 22 is formed radially inward, which forms an annular collar 24 radially outward of the cover fastening element 1. This collar 24 makes the cover fastening element 1 particularly easy to handle and also serves to enlarge the ejection area.

[0062] 1, the (standardized) light emitting diode 101 fitted to the cover fastening element 1 comprises an inner LED housing 104 and a funnel-shaped LED plate 106. Of course, the light emitting diode 101 has a light emitting radiation source (diode) in the center of the LED housing 104 in order to be tracked.

[0063] The LED housing has a basic cylindrical shape with a flat LED top surface 108 (from which radiation is emitted). The side walls and top surface have a rounded, continuous shape resembling the head of a Lego figure. At the contact area between the LED housing 104 and the LED plate 106, a circumferential groove 112 is formed on the outer surface 110, forming an undercut for securing the light-emitting diode 101. As will be described later with reference to FIGS. 2 to 4, this groove 112 is used to secure the cover fixing element 1 and forms an LED fixing interface 114 complementary to the cover fixing interface 12. Meanwhile, the LED plate 106 has a black surface, which enhances the contrast with the light-emitting diode 101 and makes tracking easier. The plate's shape also creates a gradual transition.

[0064] The cover fixing element 1 and the light-emitting diode 101 together constitute the cover fixing system 50 of the preferred embodiment of the present disclosure. In this case, the light-emitting diode 101 has an LED fixing interface 114, and the LED fixing interface 114 and the cover fixing interface 12 fit and interact with each other to form a complementary coupling structure, whereby the cover fixing element 1 is detachably fixed to the light-emitting diode 101 by pressure-contact fixing and / or form-fitting fixing. The term coupling structure here is not limited to merely geometrical aspects, but also includes a functional structure for coupling via a magnet or a magnetizable structure (including an electromagnet).

[0065] Figure 2 is a longitudinal cross-sectional view of the cover fixing element 1 shown in Figure 1, showing a state in which a sterile cover film (sterile cover drape) 2 is interposed between the cover fixing element 1 and the light-emitting diode 101. As in Figure 1, Figure 2 shows the unfixed state. When the cover fixing element 1 is guided along its longitudinal axis 6 toward the underside 8 toward the light-emitting diode, it comes into contact with the LED plate 106, resulting in the state shown in Figure 3.

[0066] 3 shows the cover fastening system 50 or cover fastening element 1 in a form-locked and pressure-locked state relative to the light-emitting diode 101, with the sterile cover film 2 clamped between the light-emitting diode 101 and the cover fastening element 1. When lowering from the state of FIG. 2 to the state of FIG. 3, the locking fingers 16 pre-press the sterile cover film 2 against the upper region of the LED housing 104, and the radial elastic preload of the locking fingers 16 further stretches the sterile cover film 2 over the LED upper surface 108. When the cover fastening element 1 is further lowered, the sterile cover film 2 is inevitably pulled downwards via the locking fingers 16 and further stretched over the LED upper surface. In the end position of the cover fastening element 1 shown in FIG. 3, all locking fingers 16 engage evenly in the grooves 112 over their entire circumference, and the locking fingers 16 at least partially spring back towards their rest position against the applied preload without the application of an external force. This provides a pressure lock in addition to a form fit, so that the cover film is securely held, fixed and positioned in a properly taut state over the radiation opening through which radiation comes in. The predetermined positioning of the taut cover film 2 makes it possible to prevent reflections and to form a standardized sterile cover for the light-emitting diode 101.

[0067] The LED plate 106 guides the cover film 2 laterally via the bank-like structure and leads it to a normal surface shape, so that the cover film 2 can cover the surgical robot 102 as it is.

[0068] FIG. 4 is a perspective view of a cover fastening system 50 including a cover fastening element 1 tautly fastening a cover film 2 over a light emitting diode 101 .

[0069] FIG. 5 is a perspective view of a surgical robot 102 according to a first preferred embodiment of the present disclosure, the surgical robot 102 having a cover fixing element 1 on its robot head 116 for fixing a cover film 2 to a light-emitting diode 101.

[0070] 6 to 10 respectively show a cover fixation element 1, a cover fixation system 50, a cover system 52 and a surgical robot 102 according to a second preferred embodiment of the present disclosure.

[0071] Unlike the previous embodiment, this embodiment does not use a geometric snap connection, but instead is attached by a magnetic connection.

[0072] 6 shows the cover fastening element 1 with the annular magnet 26 on its underside 8, while the light emitting diode 101 also has an annular magnet 118. Between the light emitting diode 101 and the cover fastening element 1, the cover film 2 is again arranged in an unfixed state.

[0073] Here, similar to the procedure of the first embodiment, when the cover fixing element 1 is lowered, the cover fixing element 1 is fixed to the light-emitting diode as shown in Fig. 7. Specifically, a gap is provided between the radially outer surface 110 of the LED housing 104 and the magnet 26 forming the cover fixing interface 12, allowing the cover film to fit snugly and be pulled downward with a very light press fit. In this way, the cover film 2 is stretched over the radiation source of the light-emitting diode 101, forming a sterilization barrier. The light-emitting diode 101 itself does not need to be sterilized.

[0074] The cover fixing element 1 has a knurled structure 28 on its radially outer side, which makes it easier to handle, for example, when pulling the cover fixing element 1 out from the light-emitting diode 101. Here too, a step 22 is formed, which widens the collar 24 and increases the angle at which the radiation source can be irradiated.

[0075] 8 and 9 show the cover fixing element 1 with an annular magnet inserted underneath it. In this embodiment, there is no LED plate 106, but instead there is a flat surface on which the cover film 2 is placed.

[0076] FIG. 10 shows, as a partial perspective view, a surgical robot 102 according to yet another preferred embodiment of the present disclosure, in which the cover fixing element 1 shown in FIGS. 6 to 9 is magnetically held and a cover film 2 is stretched over the radiation source.

[0077] 11 to 15 show a preferred embodiment of a sterilized cover film 2 to which a cover fixing element 1 is integrally attached. Here, "integrally attached" means that the cover fixing element 1 is securely attached to the cover film 2 at a predetermined position, and particularly means that it is firmly fixed by adhesive, film welding and / or other joining methods.

[0078] Figure 12 shows in longitudinal section that the cover fixing element 1 bonded to the cover film 2 forms a taut surface of the cover film 2 in the area of ​​the cover fixing element 1, which provides a predetermined surface as a sterility barrier when placed on the light emitting diode 101 as shown in Figure 13.

[0079] 14 and 15 show further views of a sterile cover film 2 with a cover fastening element 1 of a cover fastening system 50. In FIG.

[0080] 16 to 18 show yet another embodiment of the cover fastening element 1, which (like the first embodiment) has a snap connection with locking fingers 16, but in this embodiment the locking fingers 16 have locking protrusions 20 facing radially outward rather than radially inward, and are pressed against the radially inner surface of the surrounding environment of the light-emitting diode 101. In this embodiment, the peripheral wall of the protruding LED housing 104 is provided with a circumferential (inner) groove 112 that concentrically surrounds the LED housing 104. The locking fingers are pre-deformed radially inward during insertion, and then due to this elastic preload force they resiliently return radially outward and snap into the groove 112.

[0081] Figures 19 and 20 show another preferred embodiment of a sterile cover film 2 with an integral cover fastening element 1. In contrast to the first embodiment, the cover fastening element 1 is configured as a snap connection and is basically configured similarly to the cover fastening element 1 shown in Figure 1. The sterile cover film 2 is joined to the cover fastening element 1 at its upper surface 10 in this embodiment by film welding. [Explanation of symbols]

[0082] 1 cover fastening element 2 cover film 4 opening 6 longitudinal axis 8 bottom surface 10 top surface 12 cover fastening interface 14 snap connection 16 locking finger 18 locking tip 20 locking lug 22 step 24 collar 26 magnet 28 knurled structure 50 cover fastening system 52 cover system 101 light emitting diode (as navigation marker) 102 surgical robot 104 LED housing 106 LED plate 108 LED top surface 110 outer surface 112 groove 114 LED fastening interface 116 robot head 118 magnet

Claims

1. A medical cover fixing element (1) for releasably fixing a sterile cover film (2) to a navigation marker, preferably a light-emitting diode (101), in particular a light-emitting diode (101) of a surgical robot (102), the medical cover fixing element (1) comprising an opening (4) extending along a longitudinal axis (6) from a lower surface (8) toward an upper surface (10), into which a protruding, in particular rotationally symmetrically shaped object, preferably a navigation marker, more preferably a light-emitting diode (101), can be inserted from the lower surface (8) toward the upper surface (10), and further comprising a cover fixing interface (12) for releasably fixing the cover fixing element (1) by pressure fixing and / or form-locking, in particular in the region of its lower surface (8).

2. The medical cover fixing element (1) according to claim 1, The medical cover fixing element (1) is configured as a fixing clip having a snap connection portion (14) as a cover fixing interface (12), and at least one, preferably a plurality of locking fingers (16) extend in the direction of the longitudinal axis (6) toward the underside (8), the locking fingers (16) being radially elastically deflectable to hold the cover fixing element (1) by pressure fixation and / or form-fitting, and the locking fingers (16) preferably have radially inward and / or outward end locking protrusions (20) that form hooks for form-fitting.

3. The medical cover fastening element (1) according to claim 2, The cover fixing element (1) for medical use is characterized in that it has locking fingers (16) that are evenly distributed around its opening, in particular arranged rotationally symmetrically, protruding toward the underside (8), and these locking fingers (16) achieve uniform fixing of the cover fixing element (1) in the circumferential direction, and these locking fingers (16) themselves particularly form the underside (8).

4. The medical cover fixing element (1) according to claim 1, The medical cover fixation element (1) has, as a cover fixation interface (12) in the underside area, at least one magnet (26) for magnetic coupling, in particular an annular magnet (26) arranged concentrically around the circular opening (4), which magnet preferably forms at least a part of the underside (8) of the cover fixation element (1), and which is characterized in that the cover fixation element (1) can be attached by pressure fixation to a complementary magnet (118) or a metallic surface.

5. The medical cover fixing element (1) according to any one of claims 1 to 4, The medical cover fixing element (1) has at least one protrusion, particularly a radially outward protrusion along the circumferential direction, in the region of its upper surface (10), which protrusion forms a catch for manual handling.

6. The medical cover fixing element (1) according to any one of claims 1 to 5, The medical cover fixing element (1) is designed to have a rotationally symmetrical shape, in particular a conical shape in the direction of the longitudinal axis (6), and is characterized in that the outer diameter, in particular at the upper surface (10), is larger than the outer diameter at the lower surface (8) in order to improve handling, and / or the inner diameter, in particular at the upper surface (10), is larger than the inner diameter at the lower surface (8) in order to ensure visibility of the navigation marker, in particular a light-emitting diode (101).

7. The medical cover fixing element (1) according to any one of claims 1 to 6, The medical cover fixing element (1) has a step (22) facing radially outward on its radially inner side toward the top surface (10) along the direction of the longitudinal axis (6), thereby forming an annular offset in the top surface (10) area at a position away from the longitudinal axis (6) and expanding the radiation area for radiation.

8. A medical cover fixing element (1) according to any one of claims 1 to 7, The medical cover fixing element (1) is made of polyoxymethylene as a material, in particular is made entirely of said material, and is preferably colored dark, in particular entirely black, thereby optimally absorbing reflected light and increasing the contrast with the navigation marker, in particular a light-emitting diode (101).

9. A sterile cover film (2) for detachably attaching to a navigation marker, in particular a light-emitting diode (101), more particularly a light-emitting diode (101) of a surgical robot (102), comprising: A sterile cover film (2) having at least one cover fixing element (1) according to any one of claims 1 to 8 fixed thereto, in particular the sterile cover film (2) being fixed to the upper surface (10) of the cover fixing element (1), whereby the sterile cover film (2) forms a sterile barrier against the outside.

10. 1. A cover fastening system (50) having a navigation marker, in particular a light emitting diode (101), the cover fastening system (50) comprising at least one cover fastening element (1) according to any one of claims 1 to 8 or at least one sterile cover film (2) according to claim 9, the navigation marker, in particular the light emitting diode (101), having an LED fastening interface (114), the LED fastening interface (114) and the cover fastening interface (12) being adapted to each other and forming a mutually interacting complementary coupling structure, whereby the cover fastening element (1) is releasably fastened to the navigation marker, in particular the light emitting diode (101), by pressure fastening and / or form-locking.

11. The cover fastening system (50) of claim 10, The navigation marker, in particular the light-emitting diode (101), has an annular magnet (118) as an LED fixing interface (114), which interacts with a magnet (26) of opposite polarity, in particular an annular magnet, of the cover fixing interface (12); This provides a cover fixing system characterized in that pressure contact and fixing are achieved.

12. The cover fastening system (50) of claim 10, The navigation marker, in particular the light-emitting diode (101), has a hollow cylindrical LED housing (104) along the LED longitudinal axis, and has a circumferential groove (112) on the radially outer side of the LED housing (104) as an LED fixing interface (114), the circumferential groove (112) forming a circumferential catch portion and engaging with a radially elastic locking finger (16) having a radially inward locking protrusion (20) on the cover fixing interface (12).

13. A cover fastening system (50) according to any one of claims 10 to 12, The cover fixing system (50) is characterized in that the cover fixing element (1) is configured as a fixing clip having a snap connection portion (14) as a cover fixing interface (12), and a circumferential gap is formed between the LED housing (114) of the navigation marker, in particular the light-emitting diode (101), and the cover fixing element (1), the gap being set to a dimension capable of snugly accommodating a sterile cover film (2), in particular the gap width corresponding to the thickness of the cover film (2), thereby clamping the cover film (2) between the cover fixing element (1) and the navigation marker, in particular the light-emitting diode (101).

14. A sterile cover system (52) for a surgical robot (102), comprising: The surgical robot (102) comprises a robot arm connected to a robot base and a robot head (116) connected to the robot arm, the robot arm having at least one motorized robot arm segment, in particular a plurality of actively drivable robot arm segments, and a plurality of navigation markers, in particular light-emitting diodes (101), arranged on a surface of at least the robot arm segment and / or the robot head (116), the navigation markers, in particular the light-emitting diodes (101), protruding at least partially from the surface, at least some, in particular all, of the navigation markers, in particular the light-emitting diodes (101), including an LED fixing interface (114); the sterile cover system (52) further comprises: a sterile surgical cover film (2) arranged to cover a navigation marker, in particular a light-emitting diode (101), arranged on a surface of the robot arm segment and / or robot head (116); and a plurality of cover fixing elements (1) according to any one of claims 1 to 8, which interact with the sterile cover film (2), the cover fixing elements (1) being configured to be detachably coupled to the navigation marker, in particular the light-emitting diode (101), via an LED fixing interface (114), each cover fixing element (1) having an opening (4) into which the navigation marker, in particular the light-emitting diode (101), can be inserted, the cover fixing elements (1) having a cover fixing interface (12) configured complementary to the LED fixing interface (114), and the interaction of the cover fixing elements (1) with the LED fixing interface (114) secures and holds a portion of the sterile surgical cover film (2) to the navigation marker, in particular the light-emitting diode (101).

15. A surgical robot (102) for a surgical procedure on a patient, comprising: a robot arm connected to a robot base and a robot head (116) connected to the robot arm, the robot arm having at least one motorized robot arm segment, in particular a plurality of actively drivable robot arm segments; Furthermore, a plurality of navigation markers, in particular light-emitting diodes (101), are arranged on the surface of the robot arm segment and / or the robot head (116), each of which has at least a portion protruding from said surface, and at least some, in particular all, of the navigation markers, in particular light-emitting diodes (101), have an LED fixing interface (114); The surgical robot (102) further comprises at least one of a cover fixing element (1) according to any one of claims 1 to 8, a sterile cover film (2) according to claim 9, a cover fixing system (50) according to any one of claims 10 to 13, or a sterile cover system (52) according to claim 14.