Medical device having a housing and RFID tag holder, and method for producing the medical device

Abstract

The present invention relates to a medical device (1) comprising: a housing (2), in which an opening (14) is formed; an RFID tag holder (4), which comprises two RFID tag holder elements (16, 18) which engage, through the opening (14), with the housing (2) and / or with one another and enclose the housing (2) therebetween in a region around the opening (14), wherein at least one of the RFID tag holder elements (16, 18) defines a receiving space (20) for receiving an RFID tag (22) or an RFID tag carrier housing (34); and at least one sealing element (24, 54, 60), which is arranged between the housing (2) and at least one of the RFID tag holder elements (16, 18) around the whole circumference of the opening (14). The present invention also relates to a method for producing the medical device (1).

Description

[0001] Medical device with housing and RFID tag holder and method for manufacturing the medical device

[0002] Description

[0003] The present disclosure relates to a medical device having a housing and an RFID tag holder integrated or integrable into the housing, as well as a method for manufacturing the medical device.

[0004] The use of a so-called RFID tag in medical technology to document the use and reprocessing process (including ultrasonic cleaning, cleaning and disinfection, care, e.g., oiling, and / or sterilization) of a medical device is known. Data stored in the RFID tag is read out, for example, before use to ensure that the reprocessing process for the medical device has been carried out beforehand. After use, data relating to the use of the medical device is stored or updated on the RFID tag. The data relating to usage can, for example, be used to plan the reprocessing process. After the reprocessing process for the medical device, the corresponding data is stored or updated in the RFID tag.As a result, complete documentation of the use and processing process is achieved on the basis of the individual medical device.

[0005] To ensure reliable documentation for a single medical device, the RFID tag is integrated into or attached to the medical device. Several solutions are known in the state of the art for integrating or attaching the RFID tag into or to the medical device(s).

[0006] DE 10 2019 122 349 A1, which originates from the applicant, discloses an RFID tag holder for an RFID glass tag, which can be integrated into the instrument body of a medical instrument, preferably flush with a surface of the instrument body. DE 10 2020 116 932 A1, which also originates from the applicant, describes a transponder installation module that securely holds a transponder, such as an RFID glass tag, and can be inserted into the instrument body of a medical instrument, preferably flush with a surface of the instrument body.

[0007] In addition, the aforementioned publications also disclose a possibility for reading the RFID tag using an RFID antenna attached to a battery of the medical instrument.

[0008] A disadvantage, however, is that the RFID tag holder or the transponder installation module requires a certain installation depth within the instrument body due to the currently available minimum size of an RFID glass tag. Therefore, a sufficient mounting depth is required for effective attachment of the RFID tag or the holders for the RFID tag to or within the instrument body. Currently commercially available RFID glass tags have a diameter of approximately 1.4 mm.

[0009] It is therefore an object of the present disclosure to provide a medical device that eliminates or at least mitigates the aforementioned disadvantages. In particular, the present disclosure is intended to enable the integration of an RFID tag, such as an RFID glass tag, into a medical device with a thin-walled housing. Furthermore, high stability against external influences during a reprocessing process is to be ensured. At the same time, the spread of contamination or germs in the medical device is to be prevented. In particular, this makes it possible to arrange the RFID tag between a sterile and a non-sterile side of the instrument housing, regardless of the housing thickness of the instrument.

[0010] This object is achieved by the medical device and the method having the features according to the independent claims. Advantageous embodiments are the subject matter of the dependent claims and / or are described below. A medical device according to the disclosure has a housing in which an opening is formed. The housing can in particular be a metallic housing and can, at least in sections, have a wall thickness of approximately 1.2 mm or less. The housing delimits an interior space and an exterior space. One of these two spaces, interior space or exterior space, can be provided so that it is or becomes unsterile or contaminated. The other of the two spaces can thus be provided so that it is or remains sterile. It should be noted that the housing can also be formed from several elements, e.g. a cup-like base body and a lid.The cover can be plugged or screwed onto the base body and / or hinged to the base body. Furthermore, a locking device can be provided for securely closing the base body with the cover.

[0011] The medical device according to the present disclosure can, for example, be a medical, in particular surgical, instrument, preferably a hand-held instrument, such as a drilling, grinding, milling or sawing machine. The medical instrument preferably uses a battery, preferably a secondary battery, as the primary energy source for operating the electrical equipment / equipment / components of the instrument. The battery can even more preferably be accommodated in the interior of a housing, i.e. an instrument housing, of the medical instrument. Due to damage or destruction, the battery is removed from the housing of the medical instrument before a reprocessing process. The battery is stored in an operating area, e.g. in a charging station. If required during an operation, the battery is replaced by a so-calledA battery is brought to the operating room by a jumper and a surgical assistant or a surgeon then inserts the battery into the housing of the medical instrument using an insertion aid, whereby the interior of the housing becomes contaminated or unsterile. The housing is then closed with a lid in order to shield the unsterile interior from the sterile exterior. Another example of a medical device according to the disclosure is a sterile container. The sterile container comprises a container tray, a container lid for closing the container tray and a preferably manually operable locking device for locking and unlocking the container lid when the latter is in a closed position closing the container tray. The container tray or the container lid thus corresponds to the housing according to the disclosure. Sterilized surgical accessories, i.e. sterile goods, are provided in the sterile container for an operation.The surgical accessories can be stored in a sieve basket. The surgical accessories can include standard instruments and / or accessories required for an operation, such as forceps or similar, and / or special instruments, instrument sets, or specific accessories that are / are only required for a specific operation. The sterile container is loaded with the surgical accessories before the operation and then sterilized in an autoclave. Following an operation, the sterile container and the surgical accessories are subjected to a reprocessing process, during which the sterile container can be loaded with a different combination of surgical accessories if necessary. Consequently, the exterior of the sterile container is non-sterile and the interior is sterile.

[0012] Another example of a medical device is a soft package. A soft package comprises a sterilization pouch or a sterilization cloth made of textile (special nonwoven) or film, into which sterilized surgical accessories, possibly stored in a portafilter, are inserted or wrapped. The sterilization pouch, the sterilization cloth, or the film thus correspond to the disclosed housing. Consequently, in a soft package, the exterior is non-sterile and the interior is sterile.

[0013] The medical device according to the disclosure also comprises an RFID tag holder. The RFID tag holder, in turn, has two RFID tag holder elements that engage with the housing and / or with each other through the opening. The RFID tag holder elements are arranged on opposite sides of the housing. This means that one of the RFID tag holder elements is arranged in the interior and the other of the RFID tag holder elements is arranged in the exterior. In a region of the opening, the two RFID tag holder elements can engage with each other. This means that the two RFID tag holder elements are at least partially pushed or inserted into each other. Of course, the two RFID tag holder elements can also be in contact or connected to each other in the region of the opening.Alternatively or additionally, both or just one of the RFID tag holder elements can engage with the housing through the opening. Furthermore, the two RFID tag holder elements enclose the housing between them in an area around the opening. This means that the two RFID tag holder elements each completely overlap the opening. The RFID tag can therefore advantageously be arranged independently of the (wall) thickness of the instrument housing. At least one of the RFID tag holder elements defines a receiving space for receiving an RFID tag, in particular an RFID glass tag. Alternatively, the receiving space in the at least one RFID tag holder element can also be defined for receiving an RFID tag carrier housing in which the RFID tag can be arranged. Consequently, the receiving space can be formed by an RFID tag holder element alone or by the two RFID tag holder elements together.Particularly preferably, the receiving space can be formed such that it is at least partially arranged in the opening. Even more preferably, the receiving space can be formed such that the RFID tag or the RFID tag carrier housing can be removed without destruction. The receiving space can be formed such that the RFID tag can be inserted along its longitudinal direction. Alternatively, the receiving space can be formed such that the RFID tag can be snapped into the receiving space. Due to the two-part design of the RFID tag holder and the fact that the RFID tag holder elements overlap beyond a region of the opening, it is possible to integrate the RFID tag holder even into a thin-walled housing. By at least partially arranging the receiving space, i.e. the RFID tag or the RFID tag carrier housing, in the opening, a flat RFID tag holder can also be obtained.

[0014] Furthermore, the medical device according to the disclosure has at least one sealing element arranged between the housing and at least one of the RFID tag holder elements, completely surrounding the opening. This means that only one sealing element can be arranged between the housing and one of the RFID tag holder elements. Alternatively, one sealing element can be arranged between the housing and one of the RFID tag holder elements, and another sealing element can be arranged between the housing and the other of the RFID tag holder elements, so that on both sides of the housing, i.e., in the interior and the exterior, a sealing element is introduced between the housing and the RFID tag holder element arranged there. The sealing element(s) can be formed by an O-ring, adhesive, silicone, a sealing tape, a molded seal, a rubber seal, a sealing lip, or by two-component or multi-component injection molding.By using sealing elements on both sides of the housing, different types of sealing elements can be used. This reliably prevents the penetration of liquid through the opening in the housing. Furthermore, in the case of a housing with a sterile and a non-sterile space, the penetration of contamination or germs through the opening can be prevented, thus maintaining a sterile barrier.

[0015] Preferably, the housing can be made of metal, such as aluminum or stainless steel. Consequently, a robust housing can be obtained.

[0016] More preferably, the RFID tag holder, i.e., the RFID tag holder elements, can be made of a material permeable to electromagnetic waves, such as plastic. Consequently, the RFID tag can be read or written through the RFID tag holder. This is particularly advantageous when using a metallic housing. Since the RFID tag holder elements are also arranged on both sides of the housing in the area of ​​the aperture, it is possible to read or write the RFID tag from both the interior and exterior, even with a metallic housing.

[0017] The aperture can preferably have through-holes. The through-holes can be arranged around a main aperture of the aperture. In this case, one of the RFID tag holder elements can form at least one embossed projection that is embossed with the housing through a portion of the through-holes. The embossed projection can be made of plastic, like one of the RFID tag holder elements. Preferably, one of the RFID tag holder elements and the embossed projection can be formed integrally. When one of the RFID tag holder elements is mounted, the embossed projection is pushed through one portion of the through-holes and then embossed with the housing using a heated embossing tool. This means that a diameter of the embossed projection is widened on the side of the housing opposite one of the RFID tag holder elements to a diameter that is larger than that of the through-hole.In addition, the other of the RFID tag holder elements can form at least one locking projection, which is connected to the housing and / or to one of the RFID tag holder elements through the other part of the through-holes. This means that the locking projection, i.e., a locking lug of the locking projection, can engage behind the housing on the side opposite the other of the RFID tag holder elements. The locking projection is preferably formed integrally with the other of the RFID tag holder elements. Consequently, a stable integration or arrangement of the RFID tag holder in or on the housing can be achieved. However, the rusted RFID tag holder element can still be removed from the housing.

[0018] Particularly preferably, the receiving space can be defined by the RFID tag holder element that forms the locking projection. Since the RFID tag holder element, which is rusted to the housing and / or one of the RFID tag holder elements, is detachable and therefore removable, the RFID tag can be easily replaced in this case by detaching the RFID tag holder element that forms the locking projection.

[0019] Advantageously, the at least one sealing element can be arranged between the housing and the at least one of the RFID tag holder elements around the through-holes. Consequently, a reliable seal or sterile barrier is also achieved around the through-holes.

[0020] Furthermore, the RFID tag holder elements can be releasably engaged with one another through the opening. Preferably, the RFID tag holder elements can be locked together. For example, one of the RFID tag holder elements can form locking hooks, and the other of the RFID tag holder elements can form locking eyes or locking recesses for receiving the locking hooks. It is also conceivable for both RFID tag holder elements to form both locking hooks and locking eyes. Accordingly, the RFID tag holder can be detached from the housing, for example, to replace the RFID tag.

[0021] Alternatively, the RFID tag holder elements can be permanently engaged with each other through the opening. The RFID tag holder elements can be welded or glued together, particularly by ultrasonic welding. This ensures extremely reliable and secure integration of the RFID tag holder into the housing.

[0022] According to one aspect, one of the RFID tag holder elements can form the receiving space for receiving the RFID tag carrier housing. Preferably, the RFID tag carrier housing can be arranged in the RFID tag holder element such that, when the RFID tag holder elements are engaged, the RFID tag carrier housing can be removed from the RFID tag holder element that forms the receiving space. This configuration of the receiving space is particularly preferred if the RFID tag holder elements are permanently engaged with one another through the opening. Accordingly, the RFID tag can be replaced despite the permanent engagement. With a releasable engagement of the RFID tag holder elements, it is advantageously not necessary to remove the entire RFID tag holder to replace the RFID tag.

[0023] Preferably, the RFID tag carrier housing and the RFID tag holder element can be locked together. In this case, the RFID tag carrier housing can be removed from the RFID tag holder element using a tool that has, for example, a hook. It is also conceivable that a wall of the RFID tag carrier housing has to be pierced with the tool for this purpose. When inserting a new RFID tag, a new RFID tag carrier housing must then be used. Consequently, the RFID tag can be replaced in the case of a permanently engaged RFID tag holder without loosening the entire RFID tag holder. Alternatively, the RFID tag carrier housing can form a spring element. In this case, the RFID tag holder element can form a notch for receiving a portion of the spring element. The spring element can be released from the notch by pressing it with a finger, so that the RF ID tag carrier housing can be removed from the receiving space.As a result, the RFID tag carrier housing can be removed without causing any damage.

[0024] In addition, the RF ID tag carrier housing can be held in the RFID tag holder element by a securing element. The securing element can in particular be made of metal, such as spring steel, and can be inserted into a groove formed in the RFID tag holder element so that it can be pushed or elastically inserted, i.e., by compression. The groove can be arranged around an opening in the receiving space through which the RFID tag carrier housing can be inserted into the receiving space. The groove can have an open section through which the securing element can be inserted. The groove can also be inserted completely around the opening of the receiving space. The securing element can then be elastic and can be inserted into the groove by compression, i.e., can be elastically inserted. For compression, the securing element can have, for example, eyelets or grips. Consequently, the RFID tag carrier housing can be removably but securely held in the RFID tag holder element.

[0025] Advantageously, a recess can be formed in the housing around the opening. One of the RFID tag holder elements can be arranged recessed in the recess. Particularly preferably, one of the RFID tag holder elements can be arranged recessed in the recess such that a surface of the RFID tag holder element is flush or flat with a surface of the housing around the recess. Consequently, a flat arrangement of the RFID tag holder is achieved on one side of the housing.

[0026] Advantageously, the at least one sealing element can be formed by a surface seal and / or an O-ring and / or a sealing lip. When using sealing elements on both sides of the housing, different sealing elements can also be used. These sealing elements offer the advantage that they are not destroyed when an RFID tag holder element is removed and are therefore reusable. The sealing elements, in particular the O-ring, can be accommodated in a groove formed in the RFID tag holder element.

[0027] Furthermore, it is conceivable that at least one of the RFID tag holder elements is glued or welded to the housing. This approach is particularly advantageous when one of the RFID tag holder elements is mounted in the recess around the opening. In this case, the adhesive or weld seam corresponds to the sealing element.

[0028] Preferably, a signal amplification element can be provided in the RFID holder or the medical device, which is arranged in one of the RFID tag holder elements or as a separate component at least in sections around the receiving space. The signal amplification element can be a metallic component for amplifying the electromagnetic waves transmitted or received by the RFID tag. The signal amplification element can be arranged at least in sections along a circumferential direction of the opening. A full-circumferential arrangement of the signal amplification element can be preferred. The signal amplification element can extend in a direction perpendicular to the circumferential direction.

[0029] A method for producing a medical device according to the disclosure initially comprises a step for providing a housing in which an opening is formed. This is followed by a step for arranging an RFID tag holder by engaging two RFID tag holder elements through the opening with the housing and / or with each other. The RFID tag holder elements enclose the housing between them in a region around the opening. At least one of the RFID tag holder elements defines a receiving space for receiving an RFID tag or an RFID tag carrier housing. Before the step for arranging the RFID tag holder, a step also takes place for arranging at least one sealing element between the housing and at least one of the RFID tag holder elements completely around the opening.The design of the RFID tag holder and the fact that the RFID tag holder elements extend beyond the opening allow the RFID tag holder to be integrated into a thin-walled housing. The sealing element also prevents the penetration of liquids and / or contamination or germs through the opening.

[0030] Preferably, a housing can also be provided in which the opening has through-holes. The step of arranging the RFID tag holder can then comprise a step of stamping at least one stamping projection, which is formed by one of the RFID tag holder elements, through a portion of the through-holes with the housing and a step of locking at least one locking projection, which is formed by the other of the RFID tag holder elements, through the other portion of the through-holes with the housing and / or the one of the RFID tag holder elements. Consequently, a stable integration or arrangement of the RFID tag holder in or on the housing can be achieved.

[0031] Short description of the characters

[0032] Embodiments of the present disclosure will be described below with reference to the accompanying figures. In the figures, identical or corresponding elements are provided with the same reference numerals. They show:

[0033] Fig. 1 shows a medical instrument as an example of a medical device according to a first embodiment of the present disclosure;

[0034] Fig. 2 shows a battery that can be inserted into a housing of the medical instrument;

[0035] Figures 3 and 4 show an upper end of the battery, at which an RFID antenna is arranged; Figures 5 and 6 show sectional views of the medical instrument into which the battery is inserted;

[0036] Fig. 7 shows another medical instrument as an example of a medical device according to a second embodiment of the present disclosure;

[0037] Fig. 8 is a schematic view of an RFID tag holder according to the present disclosure;

[0038] Figures 9 to 12 are perspective views of an RFID tag holder according to a first embodiment of the present disclosure;

[0039] Figures 13 to 16 are perspective views of an RFID tag holder according to a second embodiment of the present disclosure;

[0040] Figures 17 to 21 are perspective views of an RFID tag holder according to a third embodiment of the present disclosure;

[0041] Figures 22 to 26 are perspective views of an RFID tag holder according to a fourth embodiment of the present disclosure;

[0042] Figures 27 to 29 are perspective views of an RFID tag holder according to a fifth embodiment of the present disclosure;

[0043] Figures 30 to 33 are perspective views of an RFID tag holder according to a sixth embodiment of the present disclosure;

[0044] Figures 34 to 40 show steps of a method for manufacturing the RFID tag holder according to the sixth embodiment of the present disclosure;

[0045] Figures 41 and 42 show a sterile container as an example of a medical device according to a third embodiment of the present disclosure; and Figure 43 shows a soft package as an example of a medical device according to a fourth embodiment of the present disclosure.

[0046] Description of embodiments

[0047] Fig. 1 shows a medical instrument as an example of a medical device 1 according to a first embodiment. The medical device 1 has an instrument housing or casing 2, which in this case is made of metal. Integrated into the casing 2 is an RFID tag holder 4 for holding or storing an RFID tag 22 (see Fig. 8), which is preferably designed as a cylindrical RFID glass tag. The RFID tag holder 4 is arranged in a region of an opening 14 (see Fig. 8) in the casing 2 and is made of a material that is permeable to electromagnetic waves, such as plastic. Due to the opening 14 in the casing 2 and the material of the RFID tag holder 4, it is possible to read or write to the RFID tag 22 from both sides of the casing 2.

[0048] Fig. 2 shows a battery 6, which can be inserted into the housing 2 through an opening formed at a lower end of the housing 2. The battery 6 is preferably a secondary battery or an accumulator and serves to supply electrical equipment / equipment / components present in the medical device 1 with energy. The battery 6 is stored in a charging station in an operating room. Due to possible damage or destruction to the battery 6, it is removed during a reprocessing process of the medical device 1. If necessary, the battery 6 is then brought to the operating room by a so-called jumper, and a surgical assistant or a surgeon inserts the battery 6 into the medical device 1 using an insertion aid, whereby the interior 10 becomes contaminated or unsterile.

[0049] As shown in Fig. 3 and Fig. 4, the battery 6 has an RFID antenna 8 at an upper end, via which the RFID tag 22 held in the RFID tag holder 4 can be read, and an electrical circuit (not shown) configured to read data from the RFID tag 22 and write data to the RFID tag 22. The RFID tag holder 4 and the RFID antenna 8 are arranged, as shown in Fig. 5 and Fig. 6, such that they face each other when the battery 6 is inserted.

[0050] Fig. 7 shows another medical instrument as a medical device 1 according to a second embodiment, which differs from the medical device 1 according to the first embodiment in that the RFID tag holder 4 is arranged in the region of the opening of the housing 2 at the lower end of the medical device 1. Furthermore, further arrangements of the RFID tag holder 4 on the housing 2 of the medical device 1 are conceivable.

[0051] Fig. 8 shows a schematic view of the medical device 1 according to the disclosure. As described, the RFID tag holder 4 is integrated into the housing 2. The housing 2 forms an interior space 10, into which the battery 6 can be inserted, and an exterior space 12. An opening 14 is formed in the housing 2, in the region of which the RFID tag holder 4 is arranged. For this purpose, the RFID tag holder 4 has an RFID tag holder element 16 and an RFID tag holder element 18, which, in the example shown in Fig. 8, engage with one another through the opening 14, in particular welded together by ultrasonic welding. It can be seen that the two RFID tag holder elements 16 and 18 overlap the opening 14 and enclose the housing 2 between them in an area around the opening 14.

[0052] The two RFID tag holder elements 16, 18 together form a receiving space 20 within their interior for receiving an RFID tag 22, which in this case is designed as a cylindrical RFID glass tag. The RFID tag 22 can be arranged in the receiving space 22 before the two RFID tag holder elements 16, 18 are joined together.

[0053] To seal the opening 14 against the passage of liquid and / or germs, i.e., to form a sterile barrier, the RFID tag holder 16 has a sealing element 24, which in this case is designed as an O-ring and is arranged or received in a groove 26 formed in the RFID tag holder element 16. To achieve a flat integration of the RFID tag holder 4 with respect to the exterior space 12, the housing 2 has a recess 28 around the opening 14, which in turn has a stepped section 30 and a tapered section 32. The RFID tag holder element 18 is then preferably shaped such that it can be inserted into the recess 28. Particularly preferably, a surface of the RFID tag holder element 18 directed towards the exterior space 12 can be flush or planar with a surface of the housing 2 directed towards the exterior space around the opening 14.Of course, it is also conceivable that a flat surface facing the interior 10 is formed by providing the recess 28 in the housing 2. The RFID tag holder element 18 can also be glued to the housing 2 in the recess 28 around the opening 14. The adhesive then corresponds to the sealing element.

[0054] The two-part design and the provision of the opening 14 make it possible to integrate the RFID tag holder 4 even into a thin-walled housing. The arrangement of at least one sealing element (e.g., the sealing element 24 or the adhesive) between the housing 2 and at least one of the two RFID tag holder elements 16 and / or 18 also prevents the passage of liquid and / or germs through the opening 14.

[0055] Embodiments of the RFID tag holder 4 are described in detail below. As in the previous description, the RFID tag holder element 16 is arranged towards the interior 10, and the RFID tag holder element 18 is arranged towards the exterior 12. Of course, this arrangement of the RFID tag holder elements can also be reversed if necessary.

[0056] First embodiment

[0057] Figures 9 to 12 show an RFID tag holder 4 according to a first embodiment of the present disclosure, which has the two RFID tag holding elements 16 and 18, which are welded or glued together through the opening 14, e.g., by ultrasonic welding. The receiving space 20 is formed in the RFID tag holding element 18 such that an RFID tag carrier housing 34, which can receive the RFID tag 22, can be introduced therein. The RFID tag carrier housing 34 is secured to the RFID tag holding element 18 by inserting latching hooks 36, which are formed by the RFID tag holding element 18, into latching recesses 38, which are formed by the RFID tag holding element 16.

[0058] Particularly preferably, the RFID tag 22 is held between two locking hooks 36, and when the RFID tag carrier housing 34 is inserted, the two locking hooks 36 are pressed together, so that the RFID tag 22 is securely held. This means that the RFID tag 22 is rusted in the RFID tag carrier housing 34. If the RFID tag 22 needs to be replaced, the RFID tag carrier housing 34 can then be removed, for example, by piercing an outer wall of the RFID carrier housing 34 with a tool and pulling it out of the RFID tag holder element 18 with the tool. Consequently, the RFID tag 22 can be replaced even when the RFID tag holder elements 16 and 18 are permanently connected.

[0059] In the present case, a signal amplification element 40 made of metal is provided in the RFID tag holder element 18, which extends around the receiving space 20, i.e., around the RFID tag 22. The signal amplification element 40 is preferably arranged along the circumference of the opening 14. Furthermore, the signal amplification element 40 extends in a direction perpendicular to the circumferential direction of the opening 14. The signal amplification element 40 can amplify electromagnetic waves received by or transmitted from the RFID tag 22.

[0060] To arrange the sealing element 24, i.e., the O-ring, on the housing 2, the RFID tag holder element 16 has the groove 26 formed in an area where the RFID tag holder element 16 rests on the housing 2 around the opening 14. Consequently, the sealing element 24 is securely held between the housing 2 and the RFID tag holder element 16. Second Embodiment

[0061] Figures 13 to 16 show an RFID tag holder 4 according to a second embodiment, which has the two RFID tag holder elements 16 and 18, which are welded or glued together through the opening 14, e.g. by ultrasonic welding.

[0062] In the present case, the receiving space 20 for receiving the RFID tag carrier housing 34, into which the RFID tag 22 can be inserted along its longitudinal direction at the end faces, is formed in the RFID tag holder element 16. The RFID tag carrier housing 34 forms a spring element 42 which, when the RFID tag carrier housing 34 is inserted, engages in a notch 44 formed in the RFID tag holder element 16. In this way, the RFID tag carrier housing 34 can be securely held in the RFID tag holder element 16. Furthermore, the RFID tag carrier housing 34 can be detached from the RFID tag holder element 16 in a non-destructive manner and without tools by actuating the spring element 42 with a finger to replace the RFID tag 22.

[0063] In the present case, the signal amplification element 40 is arranged in the RFID tag holder element 16 around the receiving space 20, i.e., the RFID tag 22. However, compared to the first embodiment, the signal amplification element 40 is provided only on the longitudinal sides of the receiving space and thus only in sections along the circumferential direction of the opening 14.

[0064] The groove 26 for arranging the sealing element 24 is also incorporated in the RFID tag holder element 16.

[0065] Third embodiment

[0066] Figures 17 to 21 show an RFID tag holder 4 according to a third embodiment, which has the two RFID tag holder elements 16 and 18, which are welded together through the opening, e.g., by ultrasonic welding. As in the second embodiment, the receiving space 20 is formed in the RFID tag holder element 18. In contrast to the second embodiment, the RFID tag holder element 34 in the third embodiment is held by an elastic securing element 46. To accommodate the securing element 46, a groove 48 is formed around an opening of the receiving space 20, and the securing element 46 can be inserted into the groove 48 by compressing the securing element 46. For this purpose, the securing element 48 can, as shown by way of example in Fig. 19, have two eyelets that can be pressed together by a tool, such as pliers or tweezers.Alternatively, the securing element 48 can also have two grips that can be pressed together by pressing them together with two fingers. Consequently, the RF ID tag carrier housing 34 can be securely held in the RFID tag holder element 16, and the RFID tag 22 can be replaced without destroying the RF ID tag carrier housing 34.

[0067] The further design of the RFID tag holder 4 according to the third embodiment is similar to that of the RFID tag holder 4 according to the second embodiment.

[0068] Fourth embodiment

[0069] Figures 22 to 26 show an RFID tag holder 4 according to a fourth embodiment, which has the two RFID tag holder elements 16 and 18, which are welded or glued together through the opening 14, for example by ultrasonic welding.

[0070] The RFID tag holder element 16 again forms the receiving space 20 for receiving the RF ID tag carrier housing 34. In the present case, however, the groove 48 has an open section, as shown in Fig. 25, through which the securing element 46 can be inserted into the groove 48. The securing element 46 preferably has an eyelet which, when the securing element 46 is inserted, protrudes beyond the RFID tag holder element 16 on one side of the open section, so that the securing element 46 can be pulled out of the groove 48 with the fingers or a tool. Consequently, the RF ID tag carrier housing 34 can be securely held in the RFID tag holder element 16, and the RFID tag 22 can be replaced without destroying the RF ID tag carrier housing 34.

[0071] Again, the signal amplification element 40 is arranged in the RFID tag holder element 16 around the receiving space 20.

[0072] In contrast to the previous embodiments, the groove 26 for receiving the sealing element 24, in particular the O-ring, is formed in the RFID tag holder element 18. This also reliably prevents the penetration of liquid and / or germs through the opening 14 of the housing 2.

[0073] Fifth embodiment

[0074] Figures 27 to 29 show an RFID tag holder 4 according to a fifth embodiment, which has the two RFID tag holder elements 16 and 18. The RFID tag holder 4 according to the fifth embodiment differs from the RFID tag holders 4 according to the previous embodiments primarily in the type of engagement of the two RFID tag holder elements 16 and 18. According to the fifth embodiment, the opening 14, as described later with reference to Fig. 34, has a main opening 56 and through holes 58 formed around the main opening 56.

[0075] The receiving space 20 is then formed in one or both RFID tag holder elements 16 and / or 18 such that it is arranged in the region of the main opening 56. According to the fifth embodiment, the receiving space 20 is formed by the RFID tag holder element 18.

[0076] In this case, the RFID tag holder element 16 forms at least one embossed projection 50 that extends through a portion of the through-holes 58 and is embossed with the housing 2. That is, after the embossed projection 50 is pushed through the corresponding through-hole 58 and the RFID tag holder element 16 is arranged adjacent to the housing 2, the embossed projection 50 is heated by an embossing tool and widened to a diameter that is larger than the diameter of the corresponding through-hole 58. Consequently, the RFID tag holder element 16 is securely held on the housing 2. As shown in Figures 28 and 29, the groove 26, in which the sealing element 24, i.e., the O-ring, is received, can preferably be formed in the RFID tag holder element 16.

[0077] Subsequently, the RFID tag holder element 18 is locked to the RFID tag holder element 16 by at least one locking projection 52. For this purpose, the RFID tag holder element 16 can, as shown in Figures 28 and 29, have a collar with locking lugs formed at corresponding locations on the locking projections 52. The signal amplification element 40 is then preferably arranged in the collar. Alternatively, locking recesses into which the locking projections 52 engage can also be formed in the collar of the RFID tag holder element 16.

[0078] This ensures a secure arrangement of the RFID tag holder 4 on the housing 2. The RFID tag holder element 18 forms the receiving space 20 for receiving the RFID tag 22 and is removably rusted to the RFID tag holder element 16. Consequently, the RFID tag 22 can be easily replaced by removing the RFID tag holder element 18, without also having to remove the RFID tag holder element 16, which is embossed with the housing 2.

[0079] Sixth embodiment

[0080] Figures 30 to 33 show an RFID tag holder 4 according to a sixth embodiment, which comprises the two RFID tag holder elements 16 and 18. The RFID tag holder 4 according to the sixth embodiment is similar to the RFID tag holder according to the fifth embodiment, and the aperture 14 again has, as described later with reference to Figure 34, the main aperture 56 and through holes 58 formed around the main aperture 56.

[0081] Again, the RFID tag holder element 16 is embossed with the housing 2, and the groove 26 is introduced into the RFID tag holder element 16. In contrast to the fifth embodiment, the RFID tag holder element 18 is not locked to the RFID tag holder element 16 via the locking projection 52, but rather to the housing 2. The locking projections 52, i.e., locking lugs of the locking projections 52, thus engage behind the housing 2 through the corresponding through-hole 58. For this purpose, the RFID tag holder element 16 can, as can be seen in Fig. 35, form recesses at the corresponding locations of the locking projections 52. However, it is also conceivable for the RFID tag holder element 18 to be locked to both the housing 2 and the RFID tag holder element 16 via differently formed locking projections.

[0082] Furthermore, the signal amplification element 40 is no longer integrated into one of the two RFID tag holder elements 16 or 18, but is designed as a separate component arranged in the region of the main opening 56 (see also Fig. 38).

[0083] Once again, a secure arrangement of the RFID tag holder 2 on the housing 2 is achieved. The RFID tag holder element 18 also forms the receiving space 20 for receiving the RFID tag 22 and is releasably fused to the housing 2. Consequently, the RFID tag 22 can be easily replaced by detaching the RFID tag holder element 18, without also having to detach the RFID tag holder element 16, which is embossed with the housing 2.

[0084] A method for manufacturing the medical device 1 having an RFID tag holder 4 according to the sixth embodiment will be described below with reference to Figures 34 to 40. It should be noted that the method is also applicable, in an adapted form, to the manufacture of medical devices 1 having the RFID tag holders 4 according to the other embodiments, in particular according to the fifth embodiment.

[0085] First, in a first step shown in Fig. 34, the housing 2 is provided, in which an opening 14 is formed, which has the main opening 56 and through holes 58. Next, a step is carried out for arranging the RFID tag holding element 16 shown in Fig. 35 on the opening 14 by passing the embossed projections 50 formed by the RFID tag holding element 16 through a part of the through holes 58. The RFID tag holding element 16 is arranged in close proximity to the housing 2, as shown in Fig. 36, so that the embossed projections 50 protrude on the opposite side of the housing 2. As already described, a sealing element is arranged between the RFID tag holding element 16 and the housing 2.In the present case, the sealing element 54 is formed by a surface seal which is shaped corresponding to the RFID tag holder element 16 and has recesses at locations of the embossed projections 50 and the depressions for receiving the locking projections 52 of the RFID tag holder element 18 (see Fig. 40).

[0086] After the RFID tag holder element 16 is tightly abutting the housing 2, the embossed projections 50 are embossed with the housing 2 by heating using an embossing tool. Accordingly, as shown in Fig. 37, the embossed projections 50 are widened or widened on a side of the housing 2 opposite the RFID tag holder element 16 to a diameter that is larger than a diameter of the corresponding through holes 58.

[0087] In the step shown in Fig. 38, the signal amplification element 40 is arranged along the circumferential direction of the main opening 56 on the RFID tag holder element 16. In the present case, the signal amplification element 40 is formed as a separate component. Of course, the signal amplification element 40 can also be integrated into one of the RFID tag holder elements 16 or 18 and then arranged together with the RFID tag holder element 16 or 18.

[0088] Finally, the RFID tag holder element 18 is arranged on the housing 2 in the region of the opening 14. The RFID tag holder element 18 has, as shown in Fig. 39, four locking projections 52 that are pushed through the remaining through-holes 58 and engage on a side of the housing 2 opposite the RFID tag holder element 18. This means that the locking projections 52 engage behind the housing 2 through the through-holes 58. This is made possible by the fact that recesses are formed in the RFID tag holder element 16 at the corresponding locations of the locking projections 52. As shown in Fig. 39, a further sealing element 60, which in this case is designed as a sealing lip attached to a collar of the RFID tag holder element 18, can be arranged on the RFID tag holder element 18.

[0089] By the method described above, the medical device 1 shown in Fig. 40 can be obtained, in which the RFID tag holder element 16 is embossed with the housing 2 and the RFID tag holder element 18 is reinforced with the housing 2. Consequently, the method can be used to stably integrate an RFID holder 4 into a thin-walled housing.

[0090] It should be noted that in the description of the embodiments, the medical instrument was described as the medical device 1. However, a medical device 1 according to a third embodiment can also be a sterile container, as shown in Figures 41 and 42. The RFID tag holder 4 can, as shown in Figure 41, be integrated into a container tray 62, which accordingly corresponds to the housing 2. Alternatively, the RFID tag holder 4 can, as shown in Figure 42, be integrated into a container lid 64 that closes the container tray 62. In this case, the container lid 64 corresponds to the housing 2. In the sterile container as the medical device according to the disclosure, the RFID tag 22, which is accommodated in the RFID tag holder 4, can receive or collect data from surgical accessories accommodated in the interior of the sterile container and, for example, transmit it to a portable data processing device, e.g.a smartphone that is present outdoors.

[0091] Furthermore, a medical device 1 according to a fourth embodiment can be a soft package. The RFID tag holder 4 can be integrated into an outer film 66 of the soft package, so that the film 66 corresponds to the housing 2. The RFID tag 22 accommodated in the RFID tag holder 4 can then also function as a data collector for surgical accessories stored in the soft package. In this case, the RFID tag 22 can also be read by the portable data processing device. List of Reference Symbols

[0092] 1 Medical device

[0093] 2 housings

[0094] 4 RFID tag holder

[0095] 6 Battery

[0096] 8 RFID antenna

[0097] 10 Interior

[0098] 12 Outdoor space

[0099] 14 Breakthrough

[0100] 16 RFID tag holder element

[0101] 18 RFID tag holder element

[0102] 20 recording room

[0103] 22 RFID tag

[0104] 24 grooves

[0105] 26 Sealing element

[0106] 28 Deepening

[0107] 30 step section

[0108] 32 tapered section

[0109] 34 RFID tag carrier housings

[0110] 36 locking hooks

[0111] 38 locking recess

[0112] 40 Signal amplification element

[0113] 42 spring element

[0114] 44 notch

[0115] 46 securing element

[0116] 48 grooves

[0117] 50 embossing projection

[0118] 52 locking projection

[0119] 54 Sealing element

[0120] 56 Main breakthrough

[0121] 58 Through hole sealing element container tray container lid

Claims

Claims 1. A medical device (1) comprising: a housing (2) in which an opening (14) is formed, an RFID tag holder (4) comprising two RFID tag holder elements (16, 18) which engage with the housing (2) and / or with each other through the opening (14) and enclose the housing (2) between them in a region around the opening (14), wherein at least one of the RFID tag holder elements (16, 18) defines a receiving space (20) for receiving an RFID tag (22) or an RFID tag carrier housing (34), and at least one sealing element (24, 54, 60) which is arranged between the housing (2) and at least one of the RFID tag holder elements (16, 18) completely around the opening (14).

2. Medical device (1) according to claim 1, wherein: the opening (14) has through holes (58), one of the RFID tag holder elements (16) forms at least one embossed projection (50) which is embossed with the housing (2) through a part of the through holes (58), and the other of the RFID tag holder elements (18) forms at least one locking projection (52) which is connected to the housing (2) and / or the one of the RFID tag holder elements (16) through the other part of the through holes (58).

3. Medical device (1) according to claim 2, wherein the receiving space (20) is defined by the RFID tag holder element (18) forming the locking projection (52).

4. Medical device (1) according to claim 2 or 3, wherein the at least one sealing element (24, 54, 60) is arranged between the housing (2) and the at least one of the RFID tag holding elements (16, 18) around the through holes (58).

5. Medical device (1) according to claim 1, wherein the RFID tag holder elements (16, 18) are releasably engaged with one another, in particular secured, through the opening.

6. Medical device (1) according to claim 1, wherein the RFID tag holder elements (16, 18) are permanently engaged with one another through the opening (14), in particular welded or glued.

7. The medical device (1) according to any one of claims 1 to 6, wherein one of the RFID tag holder elements (16, 18) forms the receiving space (20) for receiving the RF ID tag carrier housing (34), and the RFID tag carrier housing (34) is arranged in the RFID tag holder element (16, 18) such that the RFID tag carrier housing (34) is removable from the RFID tag holder element (16, 18) forming the receiving space (20) in an engaged state of the RFID tag holder elements (16, 18).

8. The medical device (1) according to claim 7, wherein the RFID tag carrier housing (34) and the RFID tag holder element (18) are rusted together.

9. The medical device (1) of claim 7, wherein the RFID tag carrier housing (34) forms a spring element (42), and the RFID tag holder element (16) forms a notch (44) for receiving a portion of the spring element (42).

10. Medical device (1) according to claim 7, wherein the RFID tag carrier housing (34) is held in the RFID tag holder element (16) by a securing element (46), which is in particular insertable or elastically insertable into a groove (48) formed in the RFID tag holder element.

11. Medical device (1) according to one of claims 1 to 10, wherein a recess (28) is formed in the housing (2) around the opening (14), and one of the RFID tag holding elements (18) is set back in the recess, in particular such that a surface of the RFID tag holding element (18) is flush or flat with a surface of the housing (2) around the recess (28).

12. Medical device (1) according to one of claims 1 to 11, wherein the at least one sealing element (24, 54, 60) is formed by a surface seal and / or an O-ring and / or by a sealing lip.

13. Medical device (1) according to one of claims 1 to 12, further comprising: a signal amplification element (40) which is arranged in one of the RFID tag holder elements or as a separate component, preferably at least in sections along a circumferential direction of the opening (14), around the receiving space (20).

14. A method for manufacturing a medical device (1 ) comprising the following steps: Providing a housing (2) in which an opening (14) is formed, Arranging an RFID tag holder (4) by engaging two RFID tag holder elements (16, 18) through the opening (14) with the housing (2) and / or with each other, wherein the RFID tag holder elements (16, 18) enclose the housing (2) between them in a region around the opening (14) and at least one of the RFID tag holder elements (16, 18) defines a receiving space (20) for receiving an RFID tag (22) or an RFID tag carrier housing (34), and before arranging the RFID tag holder (4), arranging at least one sealing element (24, 54, 60) between the housing (2) and at least one of the RFID tag holder elements (16, 18) completely around the opening (14).

15. The method according to claim 14, wherein the opening (14) has through holes (58), and the step of arranging the RFID tag holder (4) comprises embossing at least one embossing projection (50) formed by the one of the RFID tag holder elements (16) through a part of the through holes (58) with the housing (2) and locking at least one locking projection (52) formed by the other of the RFID tag holder elements (18) through the other part of the through holes (58) with the housing (2) and / or the one of the RFID tag holder elements (16).

Images