Packaging for a medical device with automatic tool recognition and method for packaging with such packaging
Patent Information
- Application Number
- DE502019014206
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-09-05
- Filing Date
- 2019-09-04
- Publication Date
- 2025-12-24
- Estimated Expiration
- 2039-09-04
Description
[0001] The present invention relates to packaging, in particular sterile packaging, for a medical device, comprising a receiving space for the medical device. It further relates to a method for automatically identifying a medical device by means of packaging according to the invention.
[0002] Various packaging and devices are known for medical devices, and especially for tools. Packaging for medical devices such as implants and tools with pointed and / or sharp working sections, for example in the form of cutting or saw edges, milling heads and drills, or threaded sections, is subject to special requirements. In addition to protecting users from injuries before and especially after use of the product, the packaged product must also be protected from unwanted influences such as contamination and damage.
[0003] Another requirement for packaging is the appropriate identification of the product inside. This is particularly important if the packaged product itself is not visible (for example, because it is covered by the packaging) or if the product is not recognizable and / or identifiable (because, for example, certain identifying characteristics such as material, dimensions, or similar are not readily apparent). However, the secure and unambiguous identification of a medical device, such as a surgical instrument, a surgical tool, or an implant, is of paramount importance for patient safety.
[0004] Another important aspect of medical devices is the communication and dissemination of tool-specific information. This might include information about whether a particular tool is suitable for a specific application and / or its condition. For example, in the case of medical devices, it is often essential to know if and how often a tool has been used, its service life, and its current stock levels. Such information is difficult or impossible to convey and maintain using standard packaging.
[0005] The current state of the art involves clearly marking the packaged tool with labels attached to or inside the packaging. A disadvantage of this approach is that, without a separate and careful inspection of the label and / or the packaging, the user cannot readily and reliably identify which tool is inside. Furthermore, additional information on such labels, such as maximum usability, dimensions, materials, etc., may be difficult for the supplier to accurately represent and for the user to record, for example, due to contamination or wear. In addition, the handling of sterile products, such as surgical instruments and tools, during removal from the packaging may be subject to limitations (such as time pressure or stress during surgery), which can complicate the user's recording and / or documentation of product-specific data.This is particularly critical because the incorrect use of medical instruments due to insufficient documentation of the specific instrument and its properties or usage characteristics can quickly lead to serious negative consequences, especially for a patient. Finally, existing packaging offers no or only limited possibilities for documented instrument identification.
[0006] Packaging is known from the prior art in which the medical device is held securely and / or in a defined position. An example of such packaging is a blister pack with a clamp in the coupling area of the device to position and hold it in a defined position within the pack. Such packaging is disclosed, for example, in DE10 2013 004 168 A1, in which the surgical device is packaged under sterile conditions in a plastic package. The package is designed in at least two parts and consists of an inner protective packaging for sensitive parts of the surgical device and a sealable blister pack that receives the protective packaging.Furthermore, a method for packaging sterile surgical instruments is proposed, in which the surgical instrument is packaged under sterile conditions in the plastic packaging. In a first step, the surgical instrument, at least partially and especially its sensitive cutting edges and working surfaces, is placed in the first protective packaging. The protective packaging, together with the surgical instrument inside, is then placed in a second blister pack, secured in position, and finally sealed with a foil seal. The disadvantage of this packaging is that, while the working edges of the instrument are very well protected, the instrument itself is not, or only with difficulty, identifiable to a user through the packaging.
[0007] Devices for recording medical devices, which have readable data carriers with tool-specific data, are already known from WO 2018 / 013413 A1, US 2007 / 215507 A1, DE 10 2007 016537 A1, WO 2018 / 052966 A1, US 2006 / 109105 A1, US 2017 / 224859 A1, DE 20 2007 004638 U1, US 2013 / 092564 A1 and US 2009 / 266728 A1. DE 20 2011 050118 U1 discloses a surgical container contents detection system. CN 108 304 897 A discloses a sterile container.
[0008] Against this background, the present invention aims to reduce the aforementioned disadvantages of the prior art, in particular to provide packaging for a medical device or a tool support designed for arrangement in the packaging, which makes it easy and safe to identify the respective packaged tool and minimizes the risk of incorrect applications of the tool.
[0009] This problem is solved according to the present invention by a package according to claim 1, i.e., a package, in particular a sterile package, for a medical device, comprising: an outer package designed as a blister pack, which has a lower tray with a recess forming a receiving space for the medical device and a lid film arranged on the lower tray for closing the receiving space; a holding device arranged in the receiving space in which the device is held; and a readable data carrier with device-specific data, which is arranged on the holding device. The foregoing problem is further solved by a method for automatically identifying a medical device by means of a package according to the invention, in particular by means of a package according to one of the appended claims, comprising the following steps: Supplier-side insertion of the tool into the holding device and insertion of the holding device into the receiving space of the packaging, supplier-side writing of the data carrier with tool-specific data, supplier-side closing of the packaging, user-side opening of the packaging, user-side identification of the tool by reading the data carrier.
[0010] A tool within the meaning of the invention is understood to be, in particular, a surgical instrument / operative tool with a generally distal, sharp-edged working section for fulfilling a surgical function and a proximal coupling section for coupling the tool to a handle unit, especially a drive handle unit. Examples of such tools are primarily rotary tools as well as sawing tools, including drills, milling cutters, saws, screw attachments, cutting blades, or grinding attachments, which are coupled to a handle and / or drive unit in a generally known manner. Furthermore, a tool within the meaning of the invention includes a spray nozzle, a high-frequency syringe, an ultrasonic blade, etc. Finally, the term "tool" within the meaning of the invention also includes implants of any type and shape, such as bone and joint implants or partial implants, stents, etc.
[0011] A particular advantage of the invention is that the tool can be automatically recognized when removed from its packaging by the user. The data carrier is designed for preferably wireless communication with an external read and / or write unit. It is particularly advantageous if a handle used with the tool has a readout device by means of which the data contained on the data carrier can be recognized and / or read, since the tool can then be automatically identified when connected / arranged / inserted with the handle. Data thus acquired can be transmitted / displayed to the user on a display unit communicating with the handle.
[0012] The data written to the data carrier can, in accordance with the invention, include an article number, a lot number, a batch number, a minimum shelf life date, an expiry date or maximum usage date, material, dimensions and geometries, intended use, previous uses and duration of use, stock levels, etc.
[0013] The general idea underlying the invention involves tool recognition, data transmission to peripheral devices, and the display of selected data to the end user. Simultaneously, further data can be logged and processed.
[0014] Advantageous embodiments of the invention are claimed in the dependent claims and are explained in more detail below.
[0015] One embodiment of the invention is characterized in that the holding device is arranged and / or held in a positionally fixed manner within the receiving space. It serves, in particular, to hold the tool, especially to hold it in a positionally fixed manner, and to position it within the receiving space in such a way that contact between sharp working sections and the packaging material is avoided and that sharp working sections are spaced apart from the packaging. By providing such a holding device, contact between the tool and parts of the packaging can be prevented or at least reliably minimized, thus preventing abrasion of packaging material by the tool. The holding device and / or the outer packaging can consist, at least partially, preferably entirely, of a resorbable material. The receiving space can be enclosed by the outer packaging, in particular to be hermetically sealed. It can also be sterile.A particular advantage of the invention is that the data carrier can be read without having to open the packaging and compromise sterility.
[0016] According to the invention, the holding device is designed separately from the outer packaging. Therefore, the tool held in the holding device can be removed from the outer packaging along with the device and, in particular, can remain in the holding device after unpacking until its final use. Preferably, the packaging and holding device are designed such that removal can be achieved by handling the holding device without direct contact with the tool, thus minimizing, if not completely eliminating, the likelihood of contamination. Furthermore, the tool, together with the holding device, can be placed on an instrument table without having to lay it down loosely. During an operation or treatment, the holder can be used to particularly advantageous effect for the temporary storage of the tool, leading to improved organization and clarity.In addition to the packaging itself, the invention provides a separate holding device that serves as an independent holder. This holder not only ensures the safe and stable storage of tools during transport within the outer packaging, but also allows for the defined positioning and safe handling of the tool during reprocessing (e.g., sterilization) and when the product is presented during surgical procedures. The holding device, along with the tool it contains, can be removed from the outer packaging and set up.
[0017] According to one embodiment of the invention, the data carrier can be an RFID tag or an NFC tag. It is particularly advantageous that its data can be read, written, and processed contactlessly and automatically, especially at any time, without requiring any special user interaction. In particular, the data carrier can be permanently readable. A data carrier can also be arranged on both the outer packaging and the holding device. The data carrier can, in particular, be affixed.
[0018] According to one embodiment of the invention, the data carrier and the outer packaging, or the data carrier and the holding device, are permanently or inseparably connected to one another. Preferably, the data carrier is glued, potted, or pressed to it. As a result, accidental detachment of the data carrier and unintentional separation of the data carrier and packaging / tool are prevented, thus ensuring with a high degree of certainty that the data on the data carrier actually belongs to the tool located in the packaging / holding device. This advantageously increases patient safety.
[0019] According to a further embodiment of the invention, the data carrier can be activated. Activation of the data carrier can be achieved, in particular, by positioning the tool relative to the packaging, outer packaging, or holding device. For example, such relative positioning can close / activate an antenna circuit and / or electrical circuit and / or switching circuit connected to the data carrier, thereby activating the data carrier and enabling it to be read. This can be accomplished by ensuring that, when the tool is positioned correctly within the packaging, the electrical circuit and / or antenna circuit and / or switching circuit is open, thus rendering it inactive. This can occur, for example, because the tool itself is insulating and interrupts the circuit, or because the tool deforms the packaging / outer packaging / holding device in such a way that the circuit is interrupted.The data carrier is activated for reading or sending the data on the data carrier by a relative positioning of the product in the receptacle or holding device, or by removing it from it.
[0020] The antenna and / or electrical circuit can be part of the packaging. In particular, it can be integrated into, arranged on, or formed within the outer packaging and / or the holding device. Preferably, the circuit is designed such that it is open (i.e., deactivated) when the tool is properly positioned within the packaging, while it is closed (i.e., activated) when the tool is removed from its intended position. This offers the advantage that the data carrier is only read when the tool is removed from the packaging, thus avoiding or reducing unnecessary data traffic and energy consumption.With regard to the method according to the invention, the data carrier can be read by a reading device preferably located in the handpiece when the tool located in the packaging, in particular the tool located in the holding device, is inserted into a handpiece intended for receiving the tool.
[0021] According to the method, the tool can be arranged in the holding device, and the data carrier can be written to either before or after the tool is positioned in the holding device, preferably under sterile conditions. This allows for great flexibility. One embodiment of the method according to the invention provides that gamma sterilization is carried out after the packaging is sealed. This ensures sterility without compromising the reliable function of the data carrier. According to one embodiment, the data carrier can also be written to after sterilization has been performed.
[0022] It is particularly advantageous if, according to a further embodiment of the invention, data read from the data carrier is displayed to a user of the tool. Alternatively or additionally, data read from the data carrier can be stored by the tool and / or forwarded to the tool supplier. The aforementioned processes preferably occur automatically, so that the data can be automatically displayed and / or forwarded and / or stored in a database.
[0023] The holding device can have a base plate. This base plate can be designed, in particular, to provide a stable standing surface for the holding device with a tool held therein, especially when unpacked, and / or a contact structure for contact with the packaging. In addition to the standing surface, the holding device can have further contact structures or sections that interact with and bear against the packaging, thus ensuring a clear and stable positioning within the packaging. If the data carrier is integrated into or arranged on such a holding device according to the invention, identifying the tool placed in the holding device, for example on an instrument table, is particularly easy during a medical procedure.
[0024] According to one embodiment of the invention, the holding device can have at least two spaced-apart retaining structures for positioning the tool in a specific orientation. Preferably, these are each arranged on the base plate and can extend from it into the receiving space. In addition to holding the tool, the retaining structures can form features with which the holding device rests against the packaging, preferably in such a way that it is secured or fixed in position within the packaging. One of the retaining structures can be arranged at the end of the holding device, particularly on the base plate. Another of the retaining structures can be arranged essentially centrally on the holding device, particularly on the base plate. This enables a particularly stable holding of the tool within the holding device.
[0025] Preferably, one of the holding structures is designed to position the tool relative to the holding device in a first direction. The other holding structure can be designed to position the tool relative to the holding device in a second and a third direction, wherein the first, second, and third directions are orthogonal to each other. Such guidance ensures that the tool is held stably in the holding device and, at the same time, allows the user to easily place it in and remove it from the holding device. It is particularly advantageous if, according to a further embodiment of the packaging, at least one of the holding structures forms a positive fit and / or a frictional fit with the tool, especially with a coupling structure of the tool.
[0026] At least one of the holding structures, and in particular both holding structures, can each have two opposing holding arms. A slot for receiving and holding the tool is formed between these arms. The holding arms can be arranged essentially perpendicular to the base plate of the holding device. They can be advantageously designed as clamping arms and, in particular, exhibit spring-like properties in a direction transverse to the slot. Removing and placing the tool in the holding structures is particularly easy if, according to one embodiment of the invention, the slot widens from proximal to distal to the base.This facilitates largely safe handling of both new and used instruments, thus improving, in particular, the injury-free disposal of tools in the holder and reducing the inherent risk of infection. According to a further development of the invention, the sides of the holding arms facing the slot can be provided with indentations. Such indentations can advantageously form locking recesses for the tool inserted into the slot, so that it is held securely yet easily removable by the user within the holding structures.
[0027] A particularly user-friendly embodiment of the invention, which prevents injuries to the user in the holding device, provides that the holding device has a protective flap that projects from the base plate into the receiving space and covers a distal end of the tool or a sharp-edged structure of the tool without contact. In this way, a user is protected from injuries caused by any sharp edges of the tool when handling the holding device with the tool held therein.
[0028] According to the invention, the packaging is designed as a blister pack. Such blister packs are cost-effective and can be manufactured for virtually any shape of product and / or holding device. The blister pack has a lower tray with a recess forming the receiving space for the tool. Such a lower tray can be easily designed with sufficient stability and shape to ensure the stable positioning of the holding device and tool. A lid film attached to the lower tray in a known manner can seal the receiving space as desired, in particular hermetically and / or sterilely. The data carrier can be positioned on the lower tray or on the lid film.
[0029] According to a further embodiment of the invention, the packaging can have a support element, for example, in the form of a sieve basket. This support element, together with the holding device and the tool held thereon, and in particular with a plurality of holding devices, each with its own tool held thereon, can be arranged in the packaging. By means of such a support element, several holding devices with tools held therein can be handled particularly easily and simultaneously, for example, placed in a sterilization unit and / or set down on an instrument table.
[0030] According to a further embodiment of the invention, the holding device can be coded, for example, by being color-coded. In this way, the invention makes it particularly easy to provide a system with which not only different products can be easily distinguished by a user, but also such coding or marking of specific tools can be retained even after the tool has been unpacked from its packaging. In particular, tools that have already been unpacked and are ready for use on an instrument table or in a sterilization unit can thus be identified particularly easily and reliably by the user. Different tools and / or holding devices can preferably be identified by different colors of the holding devices, for example, with regard to their indication or to specific product groups, etc.In this way, incorrect combinations of tools can be avoided by the coloring of the holding device, which is designed especially as a plastic injection molded part, both inside and outside the packaging.
[0031] According to a further embodiment of the invention, the holding device can be designed as a molded plastic part. If, according to a further development of the invention, it is designed as a multi-component injection molded part, it can, for example, be provided with a particularly non-slip base. This enables a stable arrangement of the holding device on an instrument table and / or a support element such as a sieve basket during a reprocessing process. Furthermore, this can greatly facilitate the handling of the holding device when removing the unused tool as well as when inserting a used tool. The data carrier can, in particular, be molded / injected into the holding device.
[0032] A particular advantage of the invention is that, when using a specific medical device, a user can reliably, easily, quickly, and especially automatically obtain information about which tool they are currently using or intend to use, and / or which tool is attached to a handle unit, without having to inspect a label or the outer packaging. In particular, a user can automatically and easily determine whether the product being used is suitable or unsuitable for a given application. A further advantage of the invention is that a user can easily determine, without having to conduct an inventory, which stocks of the relevant tool are still in their warehouse (or consignment stock, if applicable).
[0033] The present invention offers significant advantages not only for the user but also for the supplier of packaged medical devices and tools: The invention enables the supplier to easily determine which products / tools have been combined and / or used. Furthermore, it allows the supplier to track tool overload and any resulting product damage. Finally, the invention allows suppliers to offer customers customized logistics solutions.
[0034] In summary, the invention enables the recognition, and in particular the automatic recognition, of the respective product used, especially the tool attached to a handle or drive unit. Furthermore, the invention allows for particularly simple and largely error-free maintenance and / or transmission of any product-related data written to the data carrier. The invention offers, in particular, the following advantages: Direct, automated product recognition for both a user and a supplier (supply chain management (SCM), service, error analysis). Transmission of any number of additional data to the user and / or the supplier (supply chain management (SCM), service, error analysis). For the user, the invention creates a way to automatically and promptly record product-related data in a patient file.
[0035] In other words, the present invention provides a tool holder or tool support that is adapted and designed to be included in, or formed within, a sterile package to form part of the package. The tool support has at least one, preferably several (axially) spaced-apart shank clamps (each consisting of two spring-loaded or spring-loaded clamping arms / jaws) which are preferably integrally formed with a base or base plate and preferably each form at least one or more bulged sections for (partially) encompassing a tool shank.
[0036] To prevent axial movement of the tool / tool shank in the tool clamp(s), two (axially) spaced end stops are provided / mountable on the base plate.
[0037] The readable data carrier (tag) can be placed, in particular, axially on / in the base plate between the two end stops and preferably axially between two shaft support clamps.
[0038] Further features and advantages of the present invention will become apparent from the following exemplary and non-limiting description of the invention with reference to figures. These figures are merely schematic and serve only to illustrate the invention. They show: Fig. 1 a perspective view of an embodiment of a packaging according to the invention, Fig. 2 a perspective view of an embodiment of a packaging according to the invention, Fig. 3 a perspective view of a holding device with a tool held in it, Fig. 4 a perspective view of a holding device with a tool held in it, Fig. 5 an enlarged detail of the Fig. 4 , Fig. 6a plurality of holding devices, each with a tool held in them, Fig. 7 a sectional view of a holding device through its holding structure perpendicular to the longitudinal axis, Fig. 8 a sectional view of a holding device in the direction of the longitudinal axis, Fig. 9 a supervisor on the holding device of the Figure 2 and Fig. 10 a sectional view of the holding device of the Figure 9 .
[0039] The Figures 1 and 2 Each figure shows an embodiment of a packaging 1 according to the invention. This comprises an outer packaging 2 in the form of a blister 2 with a lower tray 3 having a recess 4 formed therein and a rim 5 surrounding the recess 4. The outer packaging 2 also comprises a lid film 6 arranged on the surrounding rim 5 of the lower tray 3 and hermetically sealing the recess 4, which is located in the Figure 1 and 3Each is shown in a partially opened state. Both the lower shell 3 and the lid film 6 can be made of a resorbable material.
[0040] In the recess 4 of the outer packaging 2 of the Figure 1 A holding device 7 with a tool 8 held therein is arranged as an example for a packaged product (see also Figure 3 In the present embodiment, the tool 8 is a drill 8, at the distal end of which a working section 9 in the form of a drill head 9 is formed, and at the proximal end a coupling structure 10 for arranging the tool 8 in a tool holder (not shown) of a drive handle unit is formed. Between the working section 9 and the coupling structure 10, the tool 8 has an elongated tool shank 11.
[0041] According to the invention, the holding device 7 is equipped with the Figure 1In the embodiment shown, a data carrier 42, here in the form of a data carrier that can be read / written via radio, for example in the form of an NFC or RFID tag 42, is arranged. In the embodiment of Figure 2 A data carrier 42, also in the form of an RFID tag 42, is arranged on the outer packaging 2. On the data carriers 42 of the Figures 1 and 2 Eight specific data points are stored for each tool.
[0042] The holding device 7 of the embodiment of the Figure 1 is in Figure 3The product is shown without the outer packaging 2. It is designed as a molded plastic part, consists entirely of a resorbable material, and has a base plate 12. A first retention structure 13 is formed at the proximal end of the base plate 12. This comprises two mutually parallel retention arms 14, 15, which extend substantially orthogonally from the base plate 12 towards the tool 8 and are connected to the base plate 12. A slot 16 is formed between the retention arms 14, 15, to receive the coupling structure 10 of the tool 8. A second retention structure 17 is formed in the center of the base plate 12, extending from the base plate 12 in the same direction as the first retention structure 13. The second retention structure 17 also has two opposing retention arms 19, 20, which form a receiving slot 18 between them and are both arranged substantially orthogonally to the base plate 12.A third retaining structure 23 is formed between the first retaining structure 13 and the second retaining structure 17. This third retaining structure 23 is essentially identical to the second retaining structure 17 and is therefore not described further. The data carrier 42 is arranged on the side of the base plate 12 facing the tool 8, where it is glued in place.
[0043] Figure 4 shows a holding device 7 of the Figure 3 A similar holding device 7 with a different tool 21, here in the form of a milling attachment 21, and a different data carrier 42 in the form of a data carrier that can be read / written wirelessly, for example in the form of an NFC or NFC tag 42. The milling attachment 21, like the drill 8, has the Figure 1 and 3a coupling structure 10 and a tool shank 11 and differs from the drill 8 by its distal working section 22, which is designed as a milling head 22. Nevertheless, the invention allows the drill 8 and the milling head 21 to be held in the same holding devices 7. The data carrier 42 is again arranged on the base plate 12, specifically near the coupling structure 10 of the milling attachment 21. It is connected to an antenna circuit 43. This circuit has two contacts 44a and 44b, which, when in Figure 4The tools 21, as intended, are electrically isolated from each other in the holding device 7, so that the antenna circuit 43 is interrupted. According to another embodiment, the antenna circuit can be located on the underside of the holding device 7 and can be quite large. The indicated circuit break is meant to symbolize that the antenna function is then activated there. The circuit break can also be achieved by other design features, for example, leaf springs, etc. The basic idea, however, is that a circuit is always closed or opened when the tool is removed.
[0044] In the Figure 4In the illustrated embodiment, the two contacts 44a and 44b are provided in the area of the third retaining structure 23. However, it is also conceivable that the contacts 44a and 44b are provided in different areas of the retaining device 7. For example, contact 44a can be provided in the area of / on the third retaining structure 23 and contact 44b in the area of / on the first retaining structure 13. If the tool 21 is arranged in the retaining device 7, the antenna circuit 43 is preferably also interrupted / closed in this case. If the contacts 44a and 44b are provided in different areas of the retaining device 7, unintentional contact without the tool can be better avoided.
[0045] Figure 5Figure 1 shows an enlarged detail view of the second holding structure 17 of the holding device 7. The opposing side surfaces of the holding arms 19, 20 are each provided with two superimposed indentations 24, 25 of different sizes, each for receiving tool shanks 11 of different diameters (see also Figure 1). Figure 7(which shows the second holding structure 17 in a sectional view transverse to the longitudinal axis of the tool 8, 21). The holding arms 19, 20 exhibit certain elastic spring properties and can perform a spring movement relative to each other, so that the slot 18 can widen when a tool 8, 21 is inserted and the holding arms 19, 20 spring back to their original position as soon as the shank 11 of the corresponding tool 8, 21 is positioned in the recess 24, 25. In this way, the tool 8, 21 is securely held in the holding device 7. In particular, it can be clamped between the holding arms 19, 20.With the tool 8, 21 in the recess, the retaining arms 19, 20 do not fully spring back to their original position, but remain slightly further apart, so that the two contacts 44a, 44b of the antenna circuit 43, which is electrically connected to the data carrier, are separated and the antenna circuit 43 is interrupted. Only when the tool 8, 21 is removed from the slot 18 located between the two retaining arms 19, 20 can the retaining arms 19, 20 fully spring back to their original position, in which the two contacts 44a, 44b are in contact with each other, so that with the tool 8, 21 removed, the antenna circuit 43 is closed and the electrically connected data carrier 42 can be read.
[0046] At the end of the base plate 12 opposite the first support structure 13 (on the working section side), a protective tab 38 is arranged. The protective tab 38 initially projects from the base plate 12 with an inclined section 39 at an oblique angle (here approximately 45°) and is then bent at a further angle to an end section 40, so that its end facing away from the base plate 12 is arranged approximately transversely to it. As shown in particular Figure 8 As shown, the protective flap 38 projects so far from the base plate 12 that the respective distal end of the working section 9, 22 is covered without contact. This design of the protective flap 38 provides a good gripping point in the form of the angled section 39 for a user to grasp, for example from the Figure 6The position shown is from an instrumentation table, with the working section concealed so that contact by the user can be safely prevented and thus the risk of injury minimized. Figure 8 Figure 42 also shows a data carrier that can be read / written via radio, for example in the form of an NFC or RFID tag, which is glued to the underside of the base plate 12.
[0047] Figure 6 This shows that the holding device 7 is suitable for receiving and holding different tools 8, 21, as long as these have an essentially similar basic shape with a shank 11 and a coupling structure 10 at the proximal end and differ only with regard to their respective working section 9, 22. Examples are shown in Figure 6The drill attachment 8, the milling attachment 21, a screw attachment 36, and a grinding attachment 37, wherein the shank diameters of the attachments 36 and 37 are smaller than those of the attachments 8 and 21, so that the attachments 36 and 37 are arranged in the recess 24 with the smaller diameter, and the attachments 8 and 21 are arranged in the recess 25 with the larger diameter. Furthermore, it follows from Figure 6 as also from Figure 3 the suitability of the holding device 7 (the same applies to the holding device 26 described below) in addition to fixing the position of the tool 8, 21 in the packaged state, i.e. in the Figures 1 and 2The depicted state shows that the device can be used as a holding device, separately from the outer packaging 2, to store the tool, for example, during preparation for surgery or sterilization. The underside 41 of the base plate 12, 30 forms a base 41 on which the holding device 7, 26, with a tool held therein, can be stably placed. Finally, the following is shown: Figure 6 , that the two contacts 44a and 44b of the antenna circuit 43 are in contact with each other when no tool 8, 21 is in the holding device 7. Figure 5 This shows a distance and would connect when the tool is removed.
[0048] In the recess 4 of the outer packaging 2 of the Figure 2A holding device 26 with a tool 27 held therein is arranged. In the present embodiment, the tool 27 is a saw attachment 27, at the distal end of which an active section 28 in the form of a saw blade is formed and at the proximal end of which a coupling structure 29 for arranging the tool 27 in a tool receptacle (not shown) of a drive handle unit is formed.
[0049] As the Figures 9 and 10 As shown, the holding device 26 has a base plate 30 on the upper side of which a data carrier, for example in the form of an NFC or RFID tag 42, which can be read / written via radio waves and contains tool-specific data, is attached. A first holding structure 31 and a second holding structure 32 are also arranged on the base plate 30, spaced apart from it in a direction transverse to the base plate 30. The holding device 26 of the Figures 9 and 10The device is equipped with a total of three first and three second holding structures 31, 32 to accommodate saw attachments of different shapes and / or sizes. The three different holding structures 31, 32 are fundamentally similar in design, so only one of each will be described below.
[0050] The first holding structure 31 has a spring arm 33 that can perform a spring movement towards the base plate 30. On its side facing away from the base plate 30, the spring arm 33 is provided with a locking structure 34, here in the form of a locking lug 34, which can interact with the coupling structure 29 of the saw attachment 27 and thus fix the saw attachment in position relative to the second holding structure 32 and in a direction parallel to the base plate 30. The second holding structure 32 is designed as a slot 35 through which the coupling structure of the saw attachment 27 can be pushed until it engages with the first holding structure 31 and the lug 34. The slot 35 is dimensioned such that the saw attachment 27 is positioned transversely to the base plate 30 and parallel to it in the remaining direction.The slot 35 and the spring arm 33 are designed and positioned relative to each other in such a way that the saw attachment 27 can only be brought into its intended position by compressing the spring arm 33, in which it is locked with the locking lug 34.
[0051] To remove the saw attachment 27, the spring arm 33 must be manually deformed by an operator towards the base plate 30, such that the coupling structure of the saw attachment 27 can be released from the locking lug 34 and the attachment can be pulled out of the slot 35 in a direction parallel to the base plate 30. A used saw attachment 27 can be easily placed back in the holding device 26 for temporary storage and / or disposal by simply pushing it back through the slot 35 towards the locking lug 34, whereby the spring arm 33 springs back until the locking lug 34 engages with the coupling structure 29 of the saw attachment 27 and the attachment is secured in the holding device 26.
[0052] Activation of data carrier 42 can be done in the Figures 9 and 10The embodiment shown can be implemented as follows: Each second holding structure 32, designed as a receiving bay, can be configured as a push button. For example, each receiving bay has applied conductor tracks or wires. The saw attachment 27 is configured to close an electrical circuit. This can preferably be achieved by making the saw attachment 27 from a conductive material, in particular metal, or at least having conductive layers such as an applied metal (in the case where the saw attachment 27 is made of, for example, ceramic, plastic, or composite material). For example, when the saw attachment 27 is removed from the holding device 26, the electrical circuit can be (briefly) closed by the saw attachment 27 and the data carrier 42 activated. Reference symbol list
[0053] 1 Packaging 2 Packaging / Outer packaging 3 Bottom tray 4 Recess, receiving space 5 Edge 6 Foil lid 7 Holding device 8 Product, tool, drill attachment 9 Working section, drill head 10 Coupling structure 11 Tool shank 12 Base plate 13 First holding structure 14 Holding arm 15 Holding arm 16 Slot 17 Second holding structure 18 Receiving slot 19 Holding arm, clamping arm 20 Holding arm, clamping arm 21 Tool, milling attachment 22 Working section, milling head 23 Third holding structure 24 Indentation 25 Indentation 26 Holding device 27 Tool, saw attachment 28 Working section, saw blade 29 Coupling structure 30 Base plate 31 First holding structure 32 Second holding structure 33 Spring arm 34 Locking structure, locking lug 35 Slot 36 Screw attachment 37 Grinding attachment 38 Protective tab 39 Angled section 40 End section 41 Base surface 42 Contactless readable / writable data carrier, RFID tag, NFC tag 43 Antenna circuit 44a, 44b Contact
Claims
1. A package (1), in particular a sterile package (1), for a medical tool (8, 21, 27) comprising: an outer packaging (2) formed as a blister packaging having a lower shell (3) with a recess forming a receiving space (4) for the medical tool (8, 21, 27) and a lid foil (6) arranged on the lower shell for closing the receiving space (4); a holding device (7, 26) arranged in the receiving space (4) in which the tool (8, 21, 27) is held; and a readable data carrier (42) with tool-specific data, the data carrier being arranged on the holding device (7, 26).
2. The package (1) according to claim 1, characterized in that the holding device (7, 26) is arranged in the receiving space (4) in a position-determined manner, and / or the tool (8, 21, 27) is held in a position-determined manner in the holding device (7, 26), and / or the data carrier (42) is glued onto the holding device (7, 26).
3. The package (1) according to claim 1 or 2, characterized in that the data carrier (42) is an RFID tag (42) or an NFC tag (42).
4. The package (1) according to claim 2 or 3, characterized in that the data carrier (42) and the holding device (7, 26) are glued, cast or pressed together.
5. The package (1) according to any of the preceding claims, characterized in that the data carrier (42) is configured to be activated by relative positioning of the tool (8, 21, 27) in the holding device (7, 26), in particular an aerial circuit (43) connected with the data carrier (42) is activated by such relative positioning.
6. The package (1) according to any of the preceding claims, characterized in that the package comprises an electric circuit and / or antenna circuit (43) connected to the data carrier (42).
7. The package (1) according to any of claims 1-4, further comprising an antenna circuit (43) and / or electric circuit and / or switching circuit connected to the data carrier (42), wherein the antenna circuit (43) and / or electric circuit and / or switching circuit can be activated by relative positioning of the tool (8, 21, 27) relative to the holding device (7, 26) in such a way that, when the tool (8, 21, 27) is positioned in the holding device (7, 26) in the manner intended, the antenna circuit (43) and / or electric circuit and / or switching circuit is open, i.e., inactive, and the antenna circuit (43) and / or electric circuit and / or switching circuit is closed, i.e., activated, when the tool is removed from its intended position.
8. A method for automatically identifying a medical tool (8, 21, 27) by means of a package (1) according to any of the preceding claims, the method comprising the following steps: - inserting, on the provider side, the tool (8, 21, 27) in the holding device (7, 26) and inserting the holding device (7, 26) in the receiving space (4) of the package (1); - writing, on the provider side, tool-specific data on the data carrier (42); - closing the package (1) on the provider side; - opening the package (1) on the user side; and - identifying the tool (8, 21, 27) on the user side by reading out the data carrier (42).
9. The method according to claim 8, characterized in that the tool (8, 21, 27) is arranged in the holding device (7, 26) and data is written on the data carrier (42) before or after arranging the tool (8, 21, 27) in the holding device (7, 26), preferably under sterile conditions.
10. The method according to claim 8 or 9, characterized in that a γ sterilization is carried out after closing the package (1).
11. The method according to any of claims 8 to 10, characterized in that the data carrier is read out when the tool (8, 21, 27) located in the holding device (7, 26) is inserted in a handpiece for receiving the tool (8, 21, 27) by means of a reading device preferably located in the handpiece.
12. The method according to any of claims 8 to 11, characterized in that data read out from the data carrier (42) is displayed to a user of the tool (8, 21, 27) and / or that data of the tool (8, 21, 27) read out from the data carrier (42) is stored, in particular automatically in a database, and / or forwarded, in particular forwarded automatically, to the provider of the tool (8, 21, 27).
13. The method according to any of claims 8 to 12, characterized in that the data carrier (42) is activated by relative positioning of the tool (8, 21, 27) in the holding device (7, 26) or by removal therefrom for reading out the data located on the data carrier (42) or sending the data located on the data carrier (42).