Shielding fastening element, sterile shielding film, shielding fastening system, shielding system and surgical robot with shielding

By using specially designed shielding fastening elements, the sterile shielding membrane is fastened to the navigation mark of the surgical robot, solving the problems of complex tightening and low tracking accuracy in the prior art, achieving efficient, reliable fastening and precise tracking.

CN120051255APending Publication Date: 2025-05-27B BRYAN NEW VENTURES LLC
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Patent Information

Application Number
CN202380069705.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-09-29
Filing Date
2023-09-21
Publication Date
2025-05-27

AI Technical Summary

Technical Problem

The fastening mode of the sterile mask cloth used in prior art in surgical procedures is complex and unstandardized, resulting in reduced tracking accuracy and increased surgical costs.

Method used

Using specially designed shielding fastening elements, the sterile shielding film is fastened to the navigation marks, especially the light emitting diodes, through snap-on connections or magnetic connections, thereby forming a smooth surface that prevents light reflection and diffraction from affecting tracking accuracy.

Benefits of technology

The simple, reliable and standardized fastening of navigation marks is achieved, and the fastening accuracy of the sterile masking film for navigation marks is improved, the cost of surgery is reduced, and the source of inadvertent errors is avoided.

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Abstract

The present disclosure relates to a medical masking fastening element (1) for detachably fastening a sterile masking film (2) to a navigation marker, preferably a light-emitting diode (101), in particular a light-emitting diode (101) of a surgical robot (102), having an opening (4) along a longitudinal axis (6) from a lower side (8) to an upper side (10) of the masking fastening element (1), a projecting, in particular rotationally symmetrical body, preferably a navigation mark, very preferably a light-emitting diode (101), can be introduced into the opening from the underside (6) in the direction of the upper side (10), and a shading fastening interface (12), in particular in the region of the underside (8) of the shading fastening element (1), the shielding fastening element (1) can be fastened in a force-locking and / or shape-locking manner in a detachable manner via the shielding fastening interface. The present disclosure also relates to a sterile masking film (2), a masking fastening system (50), a sterile masking system (52) and a surgical robot (102) according to the paratactic claims. (Figure 1)
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Description

Technical Field

[0001] The present disclosure relates to a medical shielding fastening element for removably fixing (temporarily coupling) a sterile shielding film / sterile shielding cloth to a navigation marker, preferably a light-emitting diode as a navigation marker, in particular a light-emitting diode of a surgical robot. In addition, the present disclosure relates to a sterile shielding film, a shielding fastening system having a navigation marker, in particular a light-emitting diode as a navigation marker, and a shielding fastening element, and the present disclosure also relates to a shielding system according to the preamble of the parallel claims and a surgical robot having shielding. Background Art

[0002] In order to track / follow the robot, it has a plurality of navigational markers, for example a plurality of (active or passive) light emitting diodes (LEDs). However, the problem here is that the robot is not sterile and a sterile barrier in the form of a shielding cloth / shielding film transparent to the radiation, in particular the infrared radiation, must be inserted for the surgical operation. In a particularly simple variant, a sterile, transparent shielding cloth can be thrown over the robot so that it completely covers the robot and thus provides a sterile barrier with respect to the robot's environment.

[0003] However, precision studies have shown that the tracking accuracy of infrared LEDs equipped with shielding is significantly reduced due to light reflections on the shielding film. Therefore, the precise orientation of the transparent sterile shield is of particular importance. A problem that also exists today is the reliable and simple fastening of the sterile shield.

[0004] For example, according to the current prior art there is a guided robot arm with an integrated laser for cutting bone structures. This bone cutting robot also has a suspended LED, wherein a sterile masking cloth / sterile suspension film / sterile masking film is fastened to the surface of the robot by means of a retractable circumferential rope or belt. However, since the application of the masking cloth and the tightening of the belt are complex and no standardized process is provided, the tightening of the belt preoperatively or intraoperatively (i.e. before or during the surgical operation / operation) may be evaluated as poor. In addition, light reflections of the masking film in the direct area around the LED can lead to further tracking inaccuracies, since there is no contrasting background.

[0005] According to the prior art, the tracking of the microscope head is also possible, but this is achieved by means of passive tracking technology by placing a black interface on the masking film (i.e. in the sterile area), on which a passive marker can be placed. This configuration has the critical disadvantage that the microscope head must also be tracked when photographing the patient in the non-sterile area. Therefore, not only sterile passive markers but also non-sterile passive markers are required, which leads to an increase in production costs and sterilization costs and therefore also to an increase in surgical costs, and in addition, for example, by accidentally exchanging sterile and non-sterile markers, further sources of error are added.

[0006] Other prior art describes a sterile end effector with an integrated LED, which is fastened to a non-sterile robot arm. This design has the disadvantage that the sterilizable LED must be integrated into the end effector at a correspondingly high cost and that the LED must even be supplied with power via a shielding film. Other prior art also describes the integration of a fixing element in at least one of the multiple links of the robot arm in order to shield the LED. Summary of the invention

[0007] The object of the present disclosure is therefore to avoid or at least reduce the disadvantages of the prior art and to provide a shielding fastening element, a sterile shielding film / covering film / shielding cloth, a shielding fastening system, a shielding system and a surgical robot, which provide a particularly simple and reliable fastening and precise tracking of navigation markers. A further sub-objective is to provide a cost-effective fastening of a sterile shielding film, which is simple to operate.

[0008] The purpose of the present disclosure is achieved in accordance with the invention with respect to a medical shielding fastening element by the features of claim 1, in accordance with the invention with respect to a surgical sterile shielding film by the features of claim 9, in accordance with the invention with respect to a shielding fastening system by the features of claim 10, in accordance with the invention with respect to a shielding system by the features of claim 14, and in accordance with the invention with respect to a surgical robot by the features of claim 15.

[0009] Therefore, the basic concept of the present disclosure stipulates that, in order to fasten the sterile shielding film, a navigation mark, especially the LED of the robot or the LED housing of the LED is used, so that it can be detachably installed on the robot to a certain extent and removed again. For this reason, a specially designed shielding fastening element is used, which makes it possible to perform accurate tracking of the navigation mark, especially the LED / LED (light emitting diode), especially the infrared LED. Therefore, although the navigation mark, such as the light emitting diode (LED) itself does not need to be sterile, the sterile shielding film is fastened by a couplable shielding fastening element and is stretched tight on the navigation mark, especially the LED), thereby forming a smooth surface of the shielding film and preventing the sterile film from affecting the tracking accuracy (light reflection and diffraction). Therefore, a smooth surface can be produced by the shielding fastening element (especially in cooperation with the housing of the LED or LED) and the tracking accuracy of the navigation mark, especially the LED, which is shielded by the sterile cloth or film can be significantly improved. The shielding film-shielding fastening element is hereby stretched tight on the navigation mark, especially the tracking LED, but the sterile barrier will not be destroyed. Thus, by correspondingly fastening the sterile masking film to the navigation marker, in particular the LED, of the surgical robot by means of a special masking fastening element, a sterile barrier can be realized in a simple, cost-effective, quickly fastenable, but reliable and standardized manner. The navigation marker, for example the LED, itself (or in its housing) is fixedly integrated into a non-sterile robot head (as end effector or with end effector), for example a microscope head or a non-sterile end effector, which is correspondingly shielded.

[0010] In other words, the technical design has as a basis a sterile shielding film, for example an LED shielding film, which can be fastened by a special shield fastening element by snap connection or magnetically to a standardized interface of a particularly non-sterile end effector (on or as a robot head), particularly preferably a microscope head, which is navigated. This standardized (LED fastening) interface can also be the housing of a navigation marker, in particular the housing of a (tracking) LED. In addition, a snap lock or magnetic lock prevents an unintentional loosening of the shield fastening element (e.g. LED shield).

[0011] In other words, according to the present disclosure, a medical shielding fastening element is provided for removably fixing a sterile shielding film / sterile shielding cloth on a navigation marker, in particular a light-emitting diode (LED), in particular a light-emitting diode of a surgical robot, the medical shielding fastener having: a (through) opening along the longitudinal axis (of the shielding fastening element) from the bottom side to the top side of the shielding fastening element, a protruding, in particular rotationally symmetrical body, preferably a navigation marker, very preferably a light-emitting diode with a housing can be introduced into the opening from the bottom side (of the shielding fastening element) in the direction of the top side, a shielding fastening interface, in particular in the area of ​​the bottom side of the shielding fastening element, the shielding fastening element can be removably fastened (configured to be couplable and decoupled) in a force-locking and / or shape-locking manner (relative to the protruding rotationally symmetrical body, in particular a navigation marker such as an LED) via the shielding fastening interface, wherein the shielding fastening element is in particular configured to be sterile and / or sterilizable.

[0012] The term underside defines the side of the shielding fastening element facing the surface to be fastened, such as a surgical robot or a navigation marker. In contrast, the upper side of the shielding fastening element forms a free side of the shielding fastening element at the end, which is oriented outwardly toward the surrounding environment.

[0013] The navigation marker is used to be tracked by a navigation system or a tracking system (eg, an optical tracking system) so as to determine at least one position of the navigation marker in space. In one embodiment, the navigation marker may be a trackable light emitting diode.

[0014] Advantageous embodiments are claimed in the dependent claims and are explained in particular below.

[0015] According to a preferred embodiment, the shielding fastening element can be designed as a fastening clip, which has a snap connection as a shielding fastening interface, wherein at least one, in particular a plurality of latching fingers / clamping arms extend in the direction of the longitudinal axis toward the bottom and can be elastically deflected in the radial direction in order to hold the shielding fastening element in a force-locking and / or form-locking manner, wherein the latching fingers preferably have radially inward and / or radially outward projections at the ends in order to form undercuts for form-locking. The radially elastic latching fingers also cause radially inward elastic preload when deflected radially outward, and vice versa. In this way, the fastening can be achieved by frictional locking (i.e., force locking when the latching fingers are elastically deflected radially against each other) and / or by form locking via latching projections and latching undercuts.

[0016] According to a further embodiment, the shield fastening element can have latching fingers uniformly distributed around its opening, in particular arranged rotationally symmetrically, projecting toward its underside, which ensure uniform circumferential fixation of the shield fastening element and which in particular form the underside itself, i.e. form the last element toward the underside. The latching fingers uniformly distributed around the circumference can thus be radially deflected and, for example, snapped together circumferentially by corresponding latching projections at the end, in order to fasten the shield fastening element.

[0017] In particular, the shield fastening element can have at least one magnet for magnetic connection in the region of the underside, in particular an annular magnet arranged concentrically around its longitudinal axis as a shield fastening interface, the annular magnet preferably itself forming at least a part of the underside of the shield fastening element in order to fasten the shield fastening element in a force-locking manner to a complementary magnet or a metal surface. Thus, a magnet is firmly integrated in the shield fastening element itself in order to fasten the shield fastening element at least in a force-locking manner (magnetically).

[0018] According to the embodiment of the (separate) magnetic shielding fastening element / LED shielding, in this variant, the magnet can be permanently integrated in a non-sterile end effector, in particular a microscope head. The shielding fastening element with integrated magnets, for example as a plastic part, can be pulled onto the LED and the magnetic force produces a detachable non-positive connection. The shielding film is thereby tensioned and a smooth surface is provided for optimal tracking of the LED.

[0019] In particular, the shield securing element can be made of a thermoplastic having an annular recess / recess into which the magnet can be inserted.

[0020] In particular, the magnet is flush closed and is surrounded only radially on the outside. In this embodiment, the magnet is therefore exposed as the underside of the shielding fastening element.

[0021] Preferably, the shielding fastening element can have at least one radially outward, especially circumferential projection in the region of its upper side, so as to construct an undercut for manual operation. In this way, the shielding fastening element can also be removed manually again when necessary.

[0022] In particular, the shielding fastening element can be designed rotationally symmetrically and have a conical shape in the direction of the longitudinal axis, wherein the outer diameter is greater on the upper side than on the lower side in order to provide good handling and / or wherein the inner diameter is greater on the upper side than on the lower side in order to ensure good visibility of navigational markings, such as light-emitting diodes. Good handling is also provided by the conical shape of the (radial) outer surface, since this shape brings about undercuts. Moreover, if the radial inner surface has a shape that is also conical, for example, starting from the height of the radiation plane of the LED, the visibility of the emitted radiation of the LED (when fastened to the LED) is improved, since the funnel-shaped shape expands the radiation range.

[0023] In particular, the shielding fastening element can have a conical shape. The conical shape of the shielding fastening element, in particular of the fastening interface of the shielding fastening element, reduces the load on the shielding film and furthermore enables simple fastening of the LED shielding.

[0024] According to a further embodiment, the shielding fastening element can have a radially outward step on its radial inner side in the direction of the longitudinal axis towards its upper side, so that in the region of the upper side a spaced-apart ring offset towards the longitudinal axis is formed for increasing the emission area for, in particular, light-emitting diodes. A disk of a type or form is provided in the center of which the radiation source (covered by the sterile shielding film) has a wall spaced further apart towards one side and the radiation angle can be increased accordingly.

[0025] Preferably, the shield securing element itself can include polyoxymethylene (POM; thermoplastic) as material or consist entirely of this material.

[0026] In particular, the fixing or fastening of the sterile masking film can be carried out from the sterile side. For this purpose, the sterile masking fastening element can be simply clamped (for example by means of a snap lock) and / or magnetically fastened to the navigation mark, in particular the light-emitting diode, starting from the sterile side of the sterile masking film. In this configuration, for example, a conventional masking film can be thrown onto a surgical robot with a navigation mark, which forms a sterile barrier. In order to fasten the sterile masking film to the robot on the one hand (so that the sterile masking film does not fall off) and in order to ensure a defined surface on the navigation mark, the sterile masking film is fastened to the navigation mark from the sterile side using the sterile masking fastening element. A simple and reliable configuration is thus achieved.

[0027] Preferably, the shielding fastening element can have a dark color, in particular even be designed to be completely black, in order to absorb reflected light as well as possible and furthermore to increase the contrast with respect to the navigation markings, in particular the light-emitting diodes.

[0028] In particular, the shielding fastening element has a dark color, in particular black (or is shown in black) on its surface. The black color has the advantage that the infrared LED is easier to identify due to the higher contrast.

[0029] According to one embodiment, the shield fastening element can have a corrugated radial outer side to improve manual operation. In particular, the shield fastening element can comprise a plurality of circumferential grooves / recesses (as grooves) spaced apart from one another along the longitudinal axis.

[0030] In particular, the shield securing element can be designed as a snap-on connection and the latching fingers can have latching projections radially outwards in order to engage in an in particular circumferential inner groove of the LED housing when elastically prestressed radially inwards and in particular fastened to the LED.

[0031] In particular, the shield fastening element can be designed to be rotationally symmetrical. As a result, no specific insertion direction of the shield fastening element is required and the user can place and fasten the shield fastening element in any orientation about its longitudinal axis.

[0032] Preferably, the shielding fastening element can have only rounded edges in order not to damage the shielding film.

[0033] Viewed in a longitudinal section along the longitudinal axis, the shield securing element can have, in particular, a concave cross-sectional shape or an L-shaped cross-sectional shape, for example in a rotationally symmetrical design.

[0034] With regard to a sterile shielding film for detachably fixing on a navigation marker, in particular a light-emitting diode, in particular a light-emitting diode of a surgical robot, this object is achieved in that at least one shielding fastening element according to the present disclosure is rigidly fixed / non-detachably mounted / fastened on the sterile shielding film, and in particular the shielding film is fixed on the upper side of the shielding fastening element, so that the sterile shielding film forms a sterile barrier outwardly.

[0035] In addition to the system with a separate sterile masking film and a masking fastening element, in this embodiment of the sterile masking film, the masking fastening element is integrated into the film itself at a set position, thereby providing a specially adapted sterile masking film for masking, for example, a robot and a covering of navigation markers, in particular light-emitting diodes.

[0036] In a variant of an integrated magnetic shielding fastening element of the sterile shielding film, the shielding fastening element is tightly integrated with a magnet on the inner side of the shielding film. The connection can be produced in particular by adhesive bonding, film welding and / or joining methods. By establishing the magnetic connection, the film is tensioned on the LED and precise tracking of the LED is possible.

[0037] In the embodiment of an integrated snap-in element or an integrated shield fastening element with a snap-in function, the shield fastening element can be fixedly integrated into the shielding film. In order to fasten the shield fastening element with the sterile shielding film to the LED fastening interface, the shield fastening element has a snap-in geometry. In particular, the snap-in geometry can tension the shielding film onto the tracking LED via the connection of the LED fastening interface and the shield fastening element.

[0038] With regard to the shielding fastening system, the object is achieved in that the shielding fastening system has a navigation marker according to the present disclosure, in particular a light emitting diode and a shielding fastening element or a sterile shielding film according to the present disclosure, and the navigation marker, in particular the light emitting diode, has an LED fastening interface, wherein the LED fastening interface and the shielding fastening interface are constructed with complementary coupling structures that cooperate with each other, so that the shielding fastening element can be removably fastened to the navigation marker, in particular the light emitting diode, in a force-locking and / or form-locking manner.

[0039] In particular, the LED fastening interface and / or the shield fastening interface with undercut can provide a secure fit of a sterile shield fastening element (e.g., an LED shield) and simultaneously allow the shield fastening element to be set and released by hand. Thus, a temporary (stable) fixation of the shield fastening element can be created, which can also be released manually again if necessary, but is designed so that it cannot be released unintentionally. In particular, the shield fastening element can be designed so that the force for release must be above a limit value of the fixation in order to prevent unintentional release.

[0040] In particular, the shield securing system can have a rotationally symmetrical funnel housing, into the center of which the housing of the light-emitting diode is inserted.

[0041] Preferably, the navigation marker, in particular the light-emitting diode, can have an annular magnet as the LED fastening interface, which cooperates with a magnet of opposite polarity, in particular annular magnet, which covers the fastening interface, to provide a force-locking (complementary polarization) fastening.

[0042] According to one embodiment, the navigation marker, in particular the light-emitting diode, can have a hollow cylindrical LED housing along the longitudinal axis of the LED and a circumferentially circumferentially circumferentially shaped groove as an LED fastening interface on the radially outer side of the LED housing in order to construct a circumferential undercut that cooperates with radially elastic locking fingers having a radially inward locking protrusion that shields the fastening interface.

[0043] According to another embodiment, the shielding fastening element can be constructed as a fastening clip having a snap connection as a shielding fastening interface, wherein a circumferential gap is constructed between the navigation marker, in particular the LED housing of the light-emitting diode, and the shielding fastening element, the gap being designed so that the sterile shielding film is precisely accommodated in the gap, in particular the width of the gap corresponds to or is slightly smaller (for example less than 10%) than the thickness of the shielding film, so that the shielding film is clamped (geometrically) between the shielding fastening element and the light-emitting diode.

[0044] With regard to the sterile shielding system, the object is achieved in the following manner: for a surgical robot, the surgical robot has a robot arm connected to a robot base and a robot head connected to the robot arm (as an end effector or with an end effector), wherein the robot arm has at least one motorized robot arm link / segment, in particular a plurality of actively actuable robot arm segments, and a plurality of navigation markers, in particular light emitting diodes (LEDs), which are arranged on the surface of the at least one robot arm segment and / or on the robot head, wherein these navigation markers, in particular the light emitting diodes, respectively protrude at least partially relative to the surface, wherein at least a subset of the navigation markers, in particular the light emitting diodes, in particular all of them, include an LED fastening interface, wherein the sterile shielding system also includes: a surgical A surgical masking film, which is adapted to be arranged on a navigation marker, especially a light-emitting diode, on a surface on a robot arm segment and / or a robot head, and a plurality of shielding fastening elements according to the present disclosure, which cooperate with the surgical masking cloth and are designed to be detachably coupled and decoupled on the navigation marker, especially the light-emitting diode via their LED fastening interface, wherein each of the shielding fastening elements has an opening for the navigation marker, especially the light-emitting diode, and the navigation marker, especially the light-emitting diode can be introduced into the opening, wherein the shielding fastening element has a shielding fastening interface that is complementary to the LED fastening interface, and the shielding fastening interface cooperates with the fastening interface to fix a part of the surgical masking film on the navigation marker, especially the light-emitting diode.

[0045] In particular, the sterile mask system can be provided as a kit in a sterile packaging having a sterile mask film and a sterile mask fastening element.

[0046] In particular, the shield system can be adapted to be fixed or fastened from the sterile side by means of a shield fastening element.

[0047] The object is achieved in a surgical robot for performing surgery on a patient in that the surgical robot comprises: a robot arm connected to a robot base and a robot head connected to the robot arm (as an end effector or having an end effector), wherein the robot arm comprises at least one motorized robot arm link / segment, in particular a plurality of actively actuatable robot arm segments, a plurality of navigation markers, in particular light emitting diodes (LEDs), which are arranged on the surface of the at least one robot arm segment and / or on the robot head, wherein the navigation markers, such as the light emitting diodes, respectively protrude at least partially relative to the surface, wherein at least a subset of the navigation markers, in particular all of the light emitting diodes, respectively comprise an LED fastening interface, and wherein the surgical robot further comprises: at least one shielding fastening element or a sterile shielding film or a shielding fastening system or a sterile shielding system according to the present disclosure.

[0048] In particular, the shield fastening element therefore has an undercut / undercut radially outwards in the region of its upper side (i.e. at its upper end), which is suitable for manually removing the shield fastening element. This makes it easier to manually grasp the shield fastening element and, for example, to pull it off.

[0049] The shield securing element has, in particular, eight latchable latching fingers / clamping arms / latching arms.

[0050] It may be advantageous to design the LED fastening interface in black and / or to mask the fastening interface in order to increase the contrast with the LED.

[0051] The object is achieved with respect to a method for producing a sterile masking film in that the method comprises the steps of: arranging a masking fastening element on the sterile masking film; and

[0052] The mask fastening element is joined to the mask film in particular by adhesive bonding or film welding.

[0053] All disclosures concerning the mask-fastening element according to the present disclosure are equally applicable concerning the sterile masking film, the mask-fastening system, the masking system and the surgical robot of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] The present disclosure is explained in more detail below with reference to the accompanying drawings using preferred embodiments.

[0055] Figure 1 A perspective view showing a shield fastening element according to a preferred embodiment used in a shield fastening system of a preferred embodiment;

[0056] Figure 2 Show Figure 1A longitudinal cross-sectional view of a shield fastening system in which a transparent sterile shielding film is arranged between the LED and the shield fastening element but has not yet been fastened;

[0057] Figure 3 Shown as Figure 2 A further longitudinal sectional view of , wherein, in the present case, however, the shield fastening element is fastened to the LED and together with the sterile shielding film;

[0058] Figure 4 Show Figure 3 A perspective view of the state of the shield fastening system shown in FIG.

[0059] Figure 5 A three-dimensional view of a surgical robot according to a preferred embodiment of the present disclosure is shown, having Figures 1 to 4 The shield fastening system and shield fastening element shown in;

[0060] Figure 6 A longitudinal sectional view showing a further preferred embodiment of a shield fastening system, wherein the further preferred embodiment of the shield fastening element comprises a magnet for fastening to an LED having a magnet, wherein the shield fastening element has not yet been fastened;

[0061] Figure 7 Shown as Figure 6 , the only difference being that the shielding fastening element is fastened to the LED and tensions and clamps the sterile shielding film;

[0062] Figure 8 Show Figure 7 A perspective view of the shielding fastening system in FIG.

[0063] Fig. 9 Show Figures 6 to 8 A perspective view of a shielding fastening element in FIG.

[0064] Fig.10 shows a perspective partial view of a surgical robot according to a further preferred embodiment, with a sterile mask and a mask fastening element attached to an LED on its robot head;

[0065] Fig.11 A perspective partial view of a sterile masking film of a further preferred embodiment is shown, which has a fixedly integrated masking fastening element;

[0066] Fig.12 A longitudinal cross-sectional view showing a preferred embodiment of a shading system having Fig.11 A sterile masking film with an integrated masking fastening element;

[0067] Fig.13 Shown as Fig.12 Another longitudinal cross-sectional view of , the only difference is that the sterile mask is fastened to the LED by a magnet;

[0068] Fig.14 and Fig.15 Show Figures 11 to 13 Additional stereoscopic views of the system in;

[0069] Fig.16 shows a three-dimensional depression or protrusion as a LED in the surface for shielding the docking area of ​​the fastening element according to a further preferred embodiment;

[0070] Fig.17 and Fig.18 A longitudinal section and a perspective view of a shield fastening element are shown, which is connected to the shield fastening element. Fig.16 The docking area in the middle cooperates and has a radially outward locking protrusion;

[0071] Fig.19 and Fig. 20 A perspective view of a sterile masking film is shown in each case, which has an integrated mask fastening element with a snap-on connection.

[0072] The accompanying drawings are schematic in nature and are only used to understand the present invention. The same elements are provided with the same reference numerals. The features of the various embodiments may be substituted for each other. DETAILED DESCRIPTION

[0073] Figures 1 to 5 A shielding fastening element, a shielding fastening system, a shielding system and a surgical robot are respectively shown according to a first preferred embodiment of the present disclosure, which cooperate with each other or form sub-components with each other.

[0074] Figure 1 A method for applying a sterile masking film 2 (see Figure 2 ) is detachably fixed to the surgical robot 102 (see Figure 5 ) of the medical shielding fastening element 1 on the LED 101 (as a navigation marker). Figure 1 As shown in FIG, the shield fastening element 1 has a central through-opening 4 as a central circular hole, wherein the opening 4 extends along a longitudinal axis 6 between an underside 6 and an upper side 10 of the shield fastening element 1 .

[0075] Through this opening 4 , a protruding light-emitting diode 101 (with the LED housing) can be introduced along the longitudinal axis 6 from the bottom side 8 in the direction of the top side ( 10 ).

[0076] The shield securing element 1 is designed to be sterile and sterilizable for surgical use. In particular, the shield securing element 1 can include a sterilizable material.

[0077] The shield fastening element 1 has a shield fastening interface 12 in or in the region of its underside 8 , via which the shield fastening element 1 is releasably fastened in a non-positive and positive manner, as explained below.

[0078] Specifically, in this embodiment, the shield fastening interface 12 is designed as a snap-on connection 14 having eight snap-on fingers 16 that are freely pivotable and protrude toward the bottom along the longitudinal axis and are arranged evenly distributed over the circumference.

[0079] The latching fingers 16 themselves are designed to cover the underside 8 of the fastening element 1 and are arranged slightly conically, i.e. in a funnel-shaped manner. This facilitates handling and snapping, as will be described later. Furthermore, the latching fingers 16 are all designed identically and taper in their width along the longitudinal axis 6 toward their latching tips 18. Furthermore, a latching projection 20 pointing radially inwards is formed on each of the latching tips 18.

[0080] In the region of the upper side 10, a circumferential step 22 is formed radially inwardly, which forms radially outwardly an annular collar 24 shielding the fastening element 1. This collar 24 serves for particularly good handling of the shielding fastening element 1 and also for expanding the possible radiation range.

[0081] As in Figure 1 As further shown in FIG. 1 , a (standardized) light emitting diode 101 adapted to the shielding fastening element 1 is provided with an inner LED housing 104 and a funnel-shaped LED disk 106. Of course, the light emitting diode 101 has a luminous radiation source (diode) in the center of the LED housing 104 to be tracked.

[0082] The LED housing has an essentially cylindrical basic shape with a flat LED top side 108 (radiation is emitted from said LED top side), wherein the transition from the side wall to the top side is designed to be rounded (similar to the head of a Lego man). In the contact area of ​​the LED housing 104 with the LED disk 6, a circumferential groove 112 is introduced on the radial outer side 110, which forms an undercut for the light-emitting diode 101. This groove 112 is used to fasten the shielding fastening element 1, as will be described later with reference to Figures 2 to 4 The LED disk 106 has a black surface and is advantageous for the contrast with the light-emitting diode 101 and thus for tracking. A soft transition is also achieved by the disk shape.

[0083] The shielding fastening element 1 and the light emitting diode 101 together form a shielding fastening system 50 of a preferred embodiment of the present disclosure. Here, the light emitting diode 101 has an LED fastening interface 114 and the LED fastening interface 114 and the shielding fastening interface 12 are coordinated and matched with each other to construct a complementary coupling structure, so that the shielding fastening element can be removably fastened to the light emitting diode in a force-locking and / or form-locking manner. The concept of the coupling structure is not only geometrically visible, but also includes a functional structure for coupling by a magnet or a magnetizable structure (electromagnet).

[0084] Figure 2 Show Figure 1 A longitudinal section through the shielding fastening element 1 in FIG. 1 , wherein, however, a sterile shielding film / sterile shielding cloth 2 is arranged between the shielding fastening element 1 and the light-emitting diode 101. Figure 1 Like in Figure 2 If the shielding fastening element 1 is now guided along its longitudinal axis 6 toward its underside 8 onto the light-emitting diode, then when it stops on the LED disk 6, a Figure 3 The status shown in .

[0085] Right now Figure 3 The shielding fastening system 50 or shielding fastening element 1 is shown in a state in which the shielding fastening element is placed on the light-emitting diode 101 in a form-fitting and force-fitting manner and the sterile shielding film 2 is clamped between the light-emitting diode 101 and the shielding fastening element 1. Figure 2 Down to Figure 3 When the shielding fastening element 1 is lowered further, the shielding film 2 is forcibly pulled downwards by the latching fingers 16 and further tensioned on the LED upper side 108. Figure 3 In the end position of the shielding fastening element 1 shown in FIG, all the latching fingers 16 engage uniformly over the circumference in the recesses 112 and the latching fingers at least partially rebound against their pretension in the direction of their rest position without the action of force. This results in a form fit and also a force fit and the shielding film is securely held and secured and perfectly tensioned above the radiation opening through which the radiation is emitted. The predefined orientation of the tensioned shielding film 2 can prevent reflections and provide a standardized sterile shielding of the light-emitting diodes 101.

[0086] The shielding film 2 is guided sideways by the LED disk 106 on a kind of ramp back toward the “normal” surface and can further shield the surgical robot 102 .

[0087] Figure 4A perspective view of a shielding fastening system 50 with a shielding fastening element 1 which tensions a shielding film 2 over a light-emitting diode 101 is shown.

[0088] Figure 5 Once again, a perspective view of a surgical robot 102 of the first preferred embodiment is shown, which has a shielding fastening element 1 on its robot head 116 for fastening a shielding film 2 to a light-emitting diode 101 .

[0089] Figures 6 to 10 A further, respective second preferred embodiment of the shielding fastening element 1 , the shielding fastening system 50 , the shielding system 52 and the surgical robot 2 is shown, respectively.

[0090] In contrast to the above-described embodiments, no geometric snap-fit ​​connection is used, but rather a magnetic coupling and the resulting fastening.

[0091] Specifically, Figure 6 The shielding fastening element 1 is shown with an annular magnet 26 on its underside 8. On the other hand, the light-emitting diode 101 also has an annular magnet 118. In the unfastened state, a shielding film 2 is again arranged between the light-emitting diode 101 and the shielding fastening element 1.

[0092] If the shielding fastening element 1 is now lowered similarly to the method of the first embodiment, the shielding fastening element 1 is fastened to the light-emitting diode, as in Figure 7 In particular, such a gap is provided between the radial outer side 110 of the LED housing 8 and the magnets 26 forming the shielding fastening interface 12, so that, to be precise, the shielding film is inserted and pulled downwards with a very slight interference fit. The shielding film 2 is thus stretched tight by the radiation source of the light-emitting diode 101 and forms a sterile barrier. The light-emitting diode 101 itself does not have to be sterile.

[0093] The shield securing element 1 has a corrugated radial outer structure 28 in order to simplify handling, for example pulling the shield securing element 1 off the light-emitting diode 101. A step 22 is also formed again, which widens the collar 24 and increases the angle of possible radiation of the radiation source.

[0094] Figure 8 and Fig. 9 A shielding fastening element 1 is shown, into which a ring magnet is inserted on its underside. In this embodiment, no LED disk 106 is provided, but rather a flat surface onto which a shielding film 2 is placed.

[0095] Fig.10 A further preferred embodiment of a surgical robot 102 is shown in a perspective partial view. Figures 6 to 9The shielding fastening element 1 is fastened to the surgical robot in a magnetically held manner and the shielding film 2 is tensioned by the radiation source.

[0096] Figures 11 to 15 A sterile masking film 2 according to a preferred embodiment is shown, which has an integrated masking fastening element 1. Integrated means that the masking fastening element 1 is fixedly connected to the masking film 2 at a predetermined position of the masking film, in particular rigidly fixed by gluing, film welding and / or other joining methods. By manufacturing.

[0097] Fig.12 The longitudinal section shows how the shielding fastening element 1 joined to the shielding film 2 creates a tensioning surface for the shielding film 2 in the region of the shielding fastening element 1 and as shown in FIG. Fig.13 The defined surface shown in FIG. 1 provides a sterile barrier when placed on the light emitting diode 101 .

[0098] Fig.14 and Fig.15 Further views of the sterile masking film 2 together with the masking fastening element 1 (of the masking fastening system 50 ) are shown.

[0099] Figures 16 to 18 A further embodiment of a shielding fastening element 1 is shown, which (similar to the first embodiment) has a snap connection with latching fingers 16, which, however, in this embodiment do not have radially inward latching projections 20, but rather radially outward latching projections and are pressed onto the radial inner surface of the surroundings of the light-emitting diode 101. In this embodiment, a circumferential (inner) groove 112 is provided in the wall surrounding the protruding LED housing 104, which groove extends concentrically around the LED housing 104. During insertion, the latching fingers are now preloaded radially inward and correspondingly latched radially outward into the groove 112 by their elastic preload force.

[0100] Fig.19 and Fig. 20 A further preferred embodiment of a sterile masking film 2 is shown, which has an integrated masking fastening element 1. In contrast to the first embodiment, the masking fastening element 1 is now designed as a snap-on connection and is essentially connected to the sterile masking film 2. Figure 1 The shielding and fastening elements 1 in FIG. 1 are designed identically. The sterile shielding film 2 is joined to the shielding and fastening element 1 on the top side 10 , in this case by film welding.

[0101] Reference numerals list

[0102] 1 Masking fastening elements

[0103] 2 Masking film

[0104] 4 Opening

[0105] 6 Vertical axis

[0106] 8 Lower side

[0107] 10 upper side

[0108] 12 Shielding fastening interface

[0109] 14 Snap-on connection

[0110] 16 Lock finger

[0111] 18 Locking tip

[0112] 20 Locking protrusion

[0113] 22 steps

[0114] 24 Flange

[0115] 26 Magnet

[0116] 28 fluted (operating) structure

[0117] 50 Shelter fastening system

[0118] 52 Shading System

[0119] 101 Light Emitting Diodes / LEDs (as navigation markers)

[0120] 102 Surgical Robot

[0121] 104 LED housing

[0122] 106 LED Panel

[0123] 108 LED upper side

[0124] 110 outside

[0125] 112 Grooves

[0126] 114 LED fastening interface

[0127] 116 Robot Head

[0128] 118 Magnet

Claims

1. A medical shielding fastening element (1) for detachably fixing a sterile shielding film (2) to a navigation marker, preferably a light-emitting diode (101), in particular the light-emitting diode (101) of a surgical robot (102), having: An opening (4) extending along a longitudinal axis (6) from the lower side (8) to the upper side (10) of the shielding fastening element (1), into which a protruding, in particular rotationally symmetric body, preferably a navigation marker, very preferably a light-emitting diode (101), can be introduced from the lower side (6) in the direction of the upper side (10). In particular, a shielding fastening interface (12) in the region of the lower side (8) of the shielding fastening element (1), by means of which the shielding fastening element (1) can be detachably fastened in a force-locking and / or form-locking manner.

2. The medical shielding fastening element (1) according to claim 1, characterized in that the shielding fastening element (1) is constructed as a fastening clip having a snap connection (14) as the shielding fastening interface (12), wherein at least one, in particular a plurality of, locking fingers (16) extend in the direction of the longitudinal axis (6) towards the lower side (8) and are elastically deflectable in the radial direction in order to hold the shielding fastening element (1) in a force-locking and / or form-locking manner, wherein preferably the locking fingers (16) have radially inward and / or radially outward end locking protrusions (20) for constructing a form-locking side recess.

3. The medical shielding fastening element (1) according to claim 2, characterized in that the shielding fastening element (1) has locking fingers (16) that are evenly distributed around its opening, are arranged in particular rotationally symmetrically, and protrude towards its lower side (8), which ensure a uniform circumferential fixation of the shielding fastening element (1) and which in particular themselves form the lower side (8).

4. The medical shielding fastening element (1) according to claim 1, characterized in that the shielding fastening element (1) has at least one magnet (26) for magnetic connection, in particular an annular magnet (26) arranged concentrically around a circular opening (4), as the shielding fastening interface (12) in the region of the lower side, which preferably itself forms at least a part of the lower side (8) of the shielding fastening element (1) in order to fasten the shielding fastening element (1) in a force-locking manner to a complementary magnet (118) or a metal surface.

5. The medical shielding fastening element (1) according to any one of the preceding claims, characterized in that the shielding fastening element (1) has at least one, in particular circumferential, protrusion radially outwards in the region of its upper side (10) in order to construct a side recess for manual operation.

6. The medical shielding fastening element (1) according to any one of the preceding claims, characterized in that the shielding fastening element (1) is designed rotationally symmetrically and has in particular a conical shape along the direction of the longitudinal axis (6). wherein, in particular, the outer diameter on the upper side (10) is greater than the outer diameter of the lower side (8) in order to provide good handling, and / or wherein, in particular, the inner diameter on the upper side (10) is greater than the inner diameter of the lower side (8) in order to ensure good visibility of the navigation marker, in particular of the light-emitting diode (101).

7. The medical shielding fastening element (1) according to any one of the preceding claims, characterized in that the shielding fastening element (1) has a radially outward step (22) on its radially inner side in the direction of the longitudinal axis (6) towards its upper side (10) in order to construct, in the region of the upper side (10), rings spaced apart and offset towards the longitudinal axis (6) in order to enlarge the emission area for radiation.

8. The medical shielding fastening element (1) according to any one of the preceding claims, characterized in that the shielding fastening element (1) has polyoxymethylene as material, in particular consists entirely of polyoxymethylene, and preferably has a dark color, in particular is even designed completely in black, in order to absorb reflected light as well as possible and, moreover, to increase the contrast relative to the navigation marker, in particular the light-emitting diode (101).

9. A sterile shielding film (2) for removably fastening to a navigation marker, in particular to a light-emitting diode (101), in particular to a light-emitting diode (101) of a surgical robot (102), characterized in that at least one shielding fastening element (1) according to any one of claims 1 to 8 is rigidly fixed to the sterile shielding film (2), and in particular the shielding film (2) is fixed on the upper side (10) of the shielding fastening element (1), so that the sterile shielding film (2) forms a sterile barrier outwards.

10. A shielding fastening system (50) having a navigation marker, in particular a light-emitting diode (101), characterized in that the shielding fastening system (50) has at least one shielding fastening element (1) according to any one of the preceding claims 1 to 8 or a sterile shielding film (2) according to claim 9, wherein the navigation marker, in particular the light-emitting diode (101), has an LED fastening interface (114), and the LED fastening interface (114) and the shielding fastening interface (12) are configured as coordinated, cooperating complementary coupling structures such that the shielding fastening element (1) can be removably fastened in a force-locking and / or form-locking manner to the navigation marker, in particular the light-emitting diode (101).

11. The shielding fastening system (50) according to claim 10, characterized in that the navigation marker, in particular the light-emitting diode (101), has an annular magnet (118) as the LED fastening interface (114), which annular magnet cooperates with a magnet (26), in particular an annular magnet, of opposite polarity of the shielding fastening interface (12) to provide a force-locking fastening.

12. The shielding fastening system (50) according to claim 10, characterized in that 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 circumferentially surrounding groove (112) as an LED fastening interface (114) on the radially outer side of the LED housing (114) in order to construct a circumferential side recess, which cooperates with a radially elastic latching finger (16) having a latching projection (20) radially inward of the shielding fastening interface (12).

13. The shielding fastening system (50) according to any one of claims 10 to 12, characterized in that the shielding fastening element (1) is configured as a fastening clip having a snap connection (14) as the shielding fastening interface (12), wherein a circumferential gap is constructed between the LED housing (114) of the navigation marker, in particular the light-emitting diode (101), and the shielding fastening element (1), and the gap is designed such that the sterile shielding film (2) is precisely received in the gap, in particular the width of the gap corresponds to the thickness of the shielding film (2), such that the shielding film (2) is clamped between the shielding fastening element (1) and the navigation marker, in particular the light-emitting diode (101).

14. A sterile shielding system (52) for a surgical robot (102), having a robot arm connected to a robot base and a robot head (116) connected to the robot arm, wherein the robot arm has at least one motorized robot arm segment, in particular a plurality of actively actuable robot arm segments, and a plurality of navigation markers, in particular light-emitting diodes (101), which are arranged on the surface of the at least one robot arm segment and / or on the robot head (106), wherein these navigation markers, in particular the light-emitting diodes (101), each at least partially project relative to the surface, wherein at least one subset, in particular all, of the navigation markers, in particular the light-emitting diodes (101), includes an LED fastening interface (114), and wherein the sterile shielding system (52) further comprises: a surgical sterile shielding film (2), which is adapted to be arranged on the navigation markers, in particular the light-emitting diodes (101), which are on the surface of the robot arm segment and / or the robot head (116), and A plurality of shielding fastening elements (1) according to any one of claims 1 to 8, said shielding fastening elements cooperating with the surgical sterile shielding film (2) and designed to be detachably coupled and decoupled via the LED fastening interface (114) of the navigation marker, in particular a light-emitting diode (101), wherein each of the shielding fastening elements (1) has an opening (4) for the navigation marker, in particular the light-emitting diode (101), into which the navigation marker, in particular the light-emitting diode (101), can be introduced, and wherein the shielding fastening element (1) has a shielding fastening interface (12) complementary to the LED fastening interface (114), the shielding fastening interface cooperating with the LED fastening interface (114) to fasten and fix a part of the surgical shielding film (2) to the navigation marker, in particular the light-emitting diode (101).

15. A surgical robot (102) for a surgical operation at a patient, comprising: a robotic arm connected to a robot base and a robotic head (116) connected to the robotic arm, wherein the robotic arm has at least one motorized robotic arm segment, in particular a plurality of actively actuable robotic arm segments, a plurality of navigation markers, in particular light-emitting diodes (101), arranged on the surface of the at least one robotic arm segment and / or on the robotic head (116), wherein these navigation markers, in particular the light-emitting diodes (101), each project at least partially relative to the surface, and wherein at least one subset, in particular all, of the navigation markers, in particular the light-emitting diodes (101), includes an LED fastening interface (114), characterized in that the surgical robot (112) further has: at least one shielding fastening element (1) according to any one of claims 1 to 8, or the sterile shielding film (2) according to claim 9, or the shielding fastening system (50) according to any one of claims 10 to 13, or the sterile shielding system (52) according to claim 14.