US20080230421A1 - Surgical data carrier - Google Patents

Abstract

The invention relates to a surgical data carrier for the identification of a medical implant, in particular, a surgical plate for the fixing of bones or bone fragments, comprising a carrier element and a connecting device which has a receptacle for the insertion of at least part of the implant. In order to make such a surgical data carrier available which has an improved handling capability, it is suggested according to the invention that the connecting device be designed in such a manner that it can be transferred from a connecting position, in which the implant is held in the receptacle, into a release position, in which the data carrier can be detached from the implant, without any forces acting on the implant. In addition, the invention relates to a surgical implantation system as well as an identification system for identifying and handling a medical implant.

Description

• The present disclosure relates to the subject matter disclosed inGerman application number 10 2007 011 086.5 of Feb. 28, 2007, which is incorporated herein by reference in its entirety and for all purposes.
BACKGROUND OF THE INVENTION
• The invention relates to a surgical data carrier for the identification of a medical implant, in particular, a surgical plate for the fixing of bones or bone fragments, comprising a carrier element and a connecting device which has a receptacle for the insertion of at least part of the implant.
• In addition, the invention relates to a surgical implantation system which has at least one medical implant, in particular, a surgical plate for the fixing of bones or bone fragments as well as a surgical data carrier which can be detachably connected to the implant for the identification of the implant, comprising a carrier element and a connecting device which has a receptacle for the insertion of at least part of the implant.
• Furthermore, the invention relates to an identification system for identifying and handling a medical implant, in particular, a surgical plate for the fixing of bones or bone fragments which has a surgical data carrier for the identification of the implant, the data carrier comprising a carrier element and a connecting device which has a receptacle for the insertion of at least part of the implant.
• In the following, the surgical data carrier will also be designated simply as “data carrier”, the surgical implantation system simply as “implantation system”.
• A surgical data carrier of the type specified at the outset is known from U.S. Pat. No. 6,929,646 B2. It is part of a surgical implantation system which comprises, apart from the data carrier, a surgical plate for the fixing of bones or bone fragments. The data carrier bears data identifying the implant. For handling the implant, the data carrier has a carrier element which serves as a handle for the implant and on which a connecting device is arranged. The connecting device comprises a receptacle for an attachment lobe which is arranged on the implant, is to be screwed to the bone or bone fragment and is held first of all in the receptacle during use of the implantation system. In order to separate the implant from the data carrier, a relative movement of data carrier and implant is required. For this purpose, pulling forces are exerted both on the implant and on the data carrier. This has proven to be disadvantageous and complicated, particularly when the implant is difficult to grasp as a result of its small size. The pulling force may be applied by way of a counterforce on the basis of a fixing of the implant to a bone or bone fragment. This does, however, involve the risk that the fixing of the implant will be impaired during detachment of the data carrier from the implant. This can have negative effects on the safekeeping of the patient.
• Therefore, it would be desirable to have a surgical data carrier, a surgical implantation system and an identification system of the type specified at the outset with an improved handling capability.
SUMMARY OF THE INVENTION
• In accordance with the invention, it is suggested in a surgical data carrier of the generic type, that the connecting device is designed in such a manner that it can be transferred from a connecting position, in which the implant is held in the receptacle, into a release position, in which the data carrier can be detached from the implant, without any forces acting on the implant.
• The data carrier according to the invention can be transferred from a connecting position into a release position, in which it can be detached from the implant, without any forces acting on the implant. Consequently, forces acting on the data carrier are sufficient for a user to transfer the connecting device from the connecting position into the release position. Subsequently, a relative movement of the implant and the data carrier can be brought about for detaching the data carrier. It is not, therefore, necessary to exert any pulling or holding force on the implant. This gives the data carrier an improved handling capability. In addition, potential negative consequences, which may be the result of detachment of the data carrier from a fixed implant, may be avoided to a great extent with the use of the surgical data carrier according to the invention.
• In the connecting position, the implant can be held in the receptacle, for example, in a force-locking, form-locking and/or frictional manner. It is, for example, possible for a section of the implant to be partially enclosed in an annular manner by the connecting device. This can form a recess for this purpose and/or engage around or behind the implant in sections. It is also conceivable for part of the implant to be held in the receptacle by way of clamping.
• It is favorable when the receptacle is enlarged during the transfer of the connecting device from the connecting position into the release position. As a result of the enlargement of the receptacle during the transfer of the connecting device into the release position, any force locking, form locking and/or frictional locking between data carrier and implant can, for example, be overcome in order to detach the data carrier from the implant. The receptacle favorably comprises an insertion opening for the implant which is likewise enlarged when the connecting device is transferred from the connecting position into the release position. The insertion opening can preferably be enlarged to such an extent that the part of the implant held in the receptacle can pass through the insertion opening during the detachment of the data carrier from the implant without having to touch the sections bordering on the insertion opening.
• It is of advantage when the connecting device is designed in such a manner that it can be transferred from the release position into the connecting position without any forces acting on the implant. This allows the data carrier to be connected to the implant without any force needing to the exerted on the implant for this purpose. On the contrary, only a force acting on the data carrier is sufficient. As a result, the data carrier has an even better handling capability.
• The connecting device is preferably designed in such a manner that it takes up the connecting position automatically proceeding from the release position. The connecting position can define, for example, a rest position of the connecting device. As a result, it can be ensured that the data carrier can be detached from the implant only by a user consciously initiating the release procedure. In addition, the connecting of the data carrier to the implant can be made easier with such an embodiment. After the insertion of at least part of the implant into the receptacle, the connecting device transfers automatically from the release position into the connecting position without any effort on the part of the user. This makes the data carrier user friendly.
• The connecting device advantageously comprises at least one connecting element which is arranged on the carrier element, limits the receptacle at least in sections and interacts with the implant for the connection of the data carrier. This favors a simple construction of the data carrier. The connecting element interacting with the implant defines a limitation of the receptacle in sections and is, in addition, arranged directly on the carrier element.
• It is favorable when the at least one connecting element has a contact surface which abuts on the implant in the connecting position. A form-locking, force-locking or frictional connection can be provided between the connecting device and the implant in the connecting position via the contact surface. It can be ensured by a form-locking, force-locking and/or frictional connection that the implant is held securely in the receptacle in the connecting position.
• In order to make a simple construction of the data carrier possible, the connecting device preferably comprises two or more connecting elements which limit the receptacle in sections. The receptacle can, in particular, be defined between them. Each connecting element therefore limits the receptacle at least in sections.
• It is of advantage when the two or more connecting elements are movable relative to one another. As a result of a relative movement of the two or more connecting elements, it is possible in a simple manner for the receptacle and/or its insertion opening to be enlarged so that the detachment of the data carrier from the implant is made possible. The transferability of the connecting device from the connecting position into the release position and/or vice versa is advantageously based on the relative movement of the two or more connecting elements. It may be provided for all or only some of the connecting elements to be movable relative to one another when more than two connecting elements are present.
• The at least one connecting element is preferably arranged or mounted on the carrier element so as to be movable. As a result, the at least one connecting element may be designed to be movable in a technically simple way. A movable mounting of the at least one connecting element may be brought about in accordance with the methods known to the person skilled in the art. A movable arrangement of the at least one connecting element on the carrier element may be achieved, for example, by way of a materially elastic section of the at least one connecting element or a materially elastic intermediate member between the carrier element and the at least one connecting element.
• It is favorable when the at least one connecting element is designed to be deformable at least in sections, preferably even elastically deformable. As a result of deformation of the at least one connecting element which can be based on a material elasticity thereof, it is possible, for example, for the at least one connecting element to be movable at least in sections. In accordance with the above explanations, the transferability of the connecting device from the connecting position into the release position and/or vice versa can be based on such a deformability of the at least one connecting element. It may be provided for the at least one connecting element to be designed to project from the carrier element.
• It is of advantage when the carrier element limits the receptacle at least in sections. This offers the possibility of giving the data carrier a simple construction. In particular, it may be provided for the at least one connecting element and the carrier element to limit the receptacle completely or essentially completely.
• The at least one connecting element is preferably designed as a snap-in element. As a result, a form-locking connection can, for example, be provided between the at least one connecting element and the implant, by way of, for example, engagement around or behind the implant. This allows the implant to be held particularly securely in the receptacle in the connecting position. The implant can also have a suitable, in particular, corresponding snap-in receptacle for the snap-in element.
• It has proven to be favorable when the at least one connecting element is designed as a clamping element. This offers the possibility of providing a force-locking or frictional connection between the at least one connecting element and the implant in the connecting position so that, as a result, the implant is held securely in the receptacle in the connecting position.
• It is of advantage when the connecting device has a securing member which secures the implant in the receptacle in the connecting position. It can be ensured as a result of the securing member that the implant is held particularly securely in the receptacle in the connecting position. A projection arranged on the at least one connecting element may be provided, for example, as securing member which forms a recess for the implant in the connecting position and/or engages around or behind it.
• The securing member can preferably be brought into engagement with a receptacle comprised by the implant since, as a result, it is possible for the implant to be held even more reliably in the receptacle in the connecting position. A design of the securing member as a snap-in nose is, for example, conceivable. This can interact, for example, with a preferably corresponding snap-in receptacle arranged in the implant.
• The carrier element is advantageously deformable at least in sections such that the connecting device can be transferred from the connecting position into the release position. As a result, the transfer of the connecting device from the connecting position into the release position may be brought about, in particular, by a force acting only on the carrier element. This can be of advantage, particularly in the case of implants which have small dimensions, such as, for example, surgical plates for the fixing of bones or bone fragments, such as those used in the field of oral, dental or facial surgery. Normally, connecting devices with receptacles for implants of this type likewise have small dimensions. A direct handling of such connecting devices is, therefore, difficult or even impossible for a user. This is the case, for example, with the implantation system described in U.S. Pat. No. 6,929,646 B2 specified at the outset. In comparison, the handling of the data carrier is improved for a user as a result of the embodiment now described. The carrier element can be configured to be sufficiently large to make simple gripping by the user possible.
• It may also be provided for the carrier element to be deformable at least in sections such that the connecting device can be transferred from the release position into the connecting position.
• The carrier element preferably comprises a first carrier element section and a second carrier element section which can be moved relative to one another. As a result, the data carrier can be designed in a simple manner in accordance with the embodiment last described. It may be provided, for example, for a connecting element of the connecting device to be arranged not only on the first but also on the second carrier element section and for these connecting elements to be movable relative to one another as a result of a relative movement of the carrier element sections. As a result of the relative movement of the connecting elements, a receptacle defined between the connecting elements can, for example, be enlarged. An implant held in the receptacle can, therefore, be released and so the data carrier can be detached from the implant.
• The carrier element advantageously has a weakened area which is arranged between the first carrier element section and the second carrier element section and has a greater deformability than at least one of the two carrier element sections. The formation of a weakened area between the carrier element sections allows the carrier element sections to be designed in a technically simple manner so as to be movable relative to one another. The increased deformability of the weakened area can be based, for example, on the fact that the carrier element has a reduced material thickness at the weakened area in comparison with at least one of the carrier element sections. The weakened area can, in particular, form a film hinge between the carrier element sections.
• The carrier element favorably comprises at least one tool element receptacle for a handling device for the data carrier on the first carrier element section and/or on the second carrier element section. This allows a tool element of the handling device which corresponds to the at least one tool element receptacle to be able to engage in the at least one tool element receptacle. If the tool element is in secure engagement with the tool element receptacle, the data carrier and, with it, an implant held in the tool element receptacle of the connecting device can be moved, transported, held or the like. This has proven to be useful during the insertion of the implant, which can be placed at its predetermined location together with the data carrier by means of the handling device, into the body of the patient. In addition, it may be provided for a force to be exerted on the first and/or the second carrier element section by means of the tool element of the handling device in order to move the two carrier element sections relative to one another and, as a result, to transfer the connecting device from the connecting position into the release position and/or vice versa.
• The at least one receptacle is preferably designed as a passage of the carrier element.
• A constructionally simple embodiment of the data carrier may be achieved in that the carrier element is of a plate-like design. In this respect, the first carrier element section and the second carrier element section are favorably designed as oppositely located sides of the plate-like carrier element, between which a weakened area can be arranged.
• The data carrier advantageously comprises a data storage device for storing data which can identify the implant. The data suitable for identifying the implant can, for example, include the name of the producer, type and size of the implant, article number, serial number, batch number or the like. As a result, it can be determined, for example, what type of implant is involved.
• When a serial number is present, a precise identification of the implant can even be carried out. This of great importance for documentation purposes for medical procedures and can serve the purpose of tracing the implant after its insertion.
• It may be provided for the data carrier to be designed such that the data are stored in a physical form. It is possible, for example, to apply the data by way of embossing on the data carrier or by spraying onto the data carrier. A utilization of the data storage device, with which the storing of data can be carried out by way of writing on the data carrier, application of labels, tags or the like, is also understood in the present case as a suitable way of storing data in a physical form.
• Furthermore, the data storage device can be designed such that the data suitable for identifying the implant are stored in an electronic form. In this respect, it may be provided for the data stored in such a manner to be modifiable and, in particular, modifiable one time.
• It is favorable when the data storage device can be read in a non-contact manner. For example, it may be read inductively with the use of a transponder, in particular, an RFID chip. This is of significance, especially in the case of data stored electronically.
• Furthermore, the data carrier can be read in a non-contact manner as a result of the use of optical means. This is understood in the present case as the reading of the data stored by the data storage device with the aid of an optical imaging device, such as, in a particularly advantageous manner, the human eye. Optical scanners and/or bar code readers, by means of which the data stored in the data storage device can be read, are also conceivable.
• It is favorable for a simplified and fast reading of the data when the data storage device can be read mechanically, i.e., with the aid of a technical device.
• The data storage device is advantageously arranged, at least partially, on the carrier element since, as a result, it is possible to give the data carrier a compact constructional form.
• It has proven to be favorable when the data carrier is produced at least partially from a plastic material. This allows a technically simple and inexpensive production of the data carrier. Polymer materials, such as polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyoxymethylene (POM), polytetrafluoroethylene (PTFE, Teflon) or the like, are, for example, conceivable.
• It is of advantage when the data carrier is produced at least partially from a shape memory metal alloy. In this respect, the movable parts of the data carrier are preferably manufactured from a shape memory metal alloy. Such an embodiment is useful, in particular, when the data carrier is reused. It can then be ensured that the data carrier can again take up a defined original shape even after several movement cycles.
• It has proven to be favorable when the data carrier is produced from a sterilizable material since this allows it to be sterilized. The data carrier can advantageously be sterilized as often as required. The sterilization is preferably brought about in a single procedure with the implant held in the receptacle. As a result of the sterilization of the data carrier, a risk of infection for a patient, for whom the implant is intended, can be reduced even when the data carrier is intended to remain in the body of the patient.
• It is of advantage when the data carrier is produced at least partially from a material which has a thermal coefficient of expansion which is greater than the thermal coefficient of expansion of titanium or that of an alloy, the main component of which is titanium. Medical implants for the fixing of bones or bone fragments are often produced from titanium or a titanium alloy, the main component of which is titanium. It is possible by means of this embodiment for the sections of the data carrier limiting the receptacle to expand to a greater extent than the implant during common sterilization of the data carrier and an implant held in the receptacle. In the case where the implant is seated in the receptacle in a form-locking manner at a normal temperature, spaces may be formed between the implant and the specified sections due to heating up during the sterilization procedure. Hot steam can penetrate the spaces during the sterilization procedure, cover the areas of the implant arranged in the receptacle and likewise sterilize them.
• The data carrier is preferably produced from a resorbable material. Normally, the data carrier is to be detached from the implant as determined after the insertion of the implant into the body of the patient. If this does not occur intentionally or also unintentionally, the risk of an infection for the patient as a result of the data carrier remaining in the body can be reduced in this way.
• It is of advantage when the data carrier can be detached from the implant free from residue since, as a result, it can be ensured that no residues of the data carrier, which represent a potential risk of infection for the patient, remain during the insertion of the implant into the body of the patient and detachment of the data carrier from the implant.
• It is favorable for the inexpensive production of the data carrier when the data carrier is designed in one piece. Preferably, it is produced, in particular, in one piece from a plastic material.
• As already mentioned, the invention also relates to a surgical implantation system.
• Moreover, in accordance with the invention, it is suggested in a generic surgical implantation system, that the connecting device is designed in such a manner that it can be transferred from a connecting position, in which the implant is held in the receptacle, into a release position, in which the data carrier can be detached from the implant, without any forces acting on the implant.
• The data carrier has the advantages already explained and so the surgical implantation system has an improved handling capability.
• It is of advantage, in particular, when the data carrier is designed as one of the data carriers described above. The implantation system then has the additional advantages mentioned in the explanations concerning these data carriers.
• As already mentioned, the invention relates, in addition, to an identification system for identifying and handling a medical implant.
• Furthermore, in accordance with the invention, it is suggested in a generic identification system, that the connecting device is designed in such a manner that it can be transferred from a connecting position, in which the implant is held in the receptacle, into a release position, in which the data carrier can be detached from the implant, without any forces acting on the implant and that the identification system comprises a handling device for transferring the connecting device from the connecting position into the release position.
• The identification system has the advantages already specified in conjunction with the explanations concerning the data carrier. The connecting device may be transferred from the connecting position into the release position by means of the handling device in order to detach the data carrier from the implant.
• The data carrier is, in particular, advantageously designed as one of the data carriers described above. The identification system then has the additional advantages mentioned in the explanations concerning these data carriers.
• It is favorable when the handling device has a first tool element as well as a second tool element moveable relative to it, these tool elements each being able to be brought into engagement with the carrier element or to abut on it. If the carrier element has, for example, two carrier element sections which can be moved relative to one another, a relative movement of the carrier element sections can be initiated by bringing the first tool element into engagement with the first carrier element section and the second tool element into engagement with the second carrier element section. If the carrier element sections interact with connecting elements defining the connecting device, a relative movement of the connecting elements can also be brought about as a result. A receptacle defined between the connecting elements can be enlarged so that the data carrier can be detached from the implant.
• In a preferred embodiment of the identification system, the first tool element and the second tool element can engage in tool element receptacles which are arranged on the first carrier element section and section carrier element section, respectively, and are designed to correspond to the first and second tool elements, respectively, during use of the handling device.
• In a further, preferred embodiment of the identification system, the first tool element and/or the second tool element each have at least one carrier element receptacle for engaging with the first carrier element section and the second carrier element section, respectively, in sections during use of the handling device.
• In the last two embodiments mentioned, a relative movement of the carrier element sections of the carrier element can be brought about, as explained above, as a result of a relative movement of the two tool elements in order to initiate the detachment of the data carrier from the implant. When the first and/or the second tool element is in engagement with the carrier element, it is, in addition, possible to move, transport, hold the data carrier or the like, preferably with an implant held in the receptacle. For example, the data carrier can be transported by means of the handling device to the predetermined location, i.e., for example, the bone or the bone fragment with an implant held in the receptacle during the insertion of the implant into the body of a patient. Subsequently, the implant can be fixed to the bone or bone fragment and then the data carrier detached from the implant by means of the handling device.
• It is favorable when the first tool element and/or the second tool element are designed as arms of forceps. Forceps are part of the standard equipment for an operative set of instruments and can be used as a handling device. As a result, it is not necessary to make a handling device available which is specially configured for the data carrier and so such an identification system can be offered inexpensively.
• The first tool element and/or the second tool element is preferably designed as a plunger. This can abut on the carrier element in order to act on it with a force in order to bring about relative movement of the carrier element sections.
• It is of advantage when the first tool element and the second tool element can be displaced and/or pivoted relative to one another. As explained, a relative movement of the carrier element sections for the detachment of the data carrier can be initiated as a result of the relative movement of the tool elements.
• The following description of preferred embodiments serves to explain the invention in greater detail in conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1: shows a perspective view of a first embodiment of a surgical implantation system according to the invention;
• FIG. 2: shows a sectional view along line2-2 inFIG. 1;
• FIG. 3: shows a view similar toFIG. 2 during a sterilization procedure of the surgical implantation system in the heated state;
• FIG. 4: shows a second, preferred embodiment of a surgical implantation system according to the invention in a perspective view;
• FIG. 5: shows a third, preferred embodiment of a surgical implantation system according to the invention in a perspective view;
• FIG. 6: shows a fourth, preferred embodiment of a surgical implantation system according to the invention in a perspective view;
• FIG. 7: shows a fifth, preferred embodiment of the surgical implantation system according to the invention in a perspective view;
• FIG. 8: shows a partial illustration of a first, preferred embodiment of an identification system according to the invention with an implant in a sectional view similar toFIG. 2;
• FIG. 9: shows a view similar toFIG. 8 during the detachment of the surgical data carrier from the implant;
• FIG. 10: shows a perspective, partial illustration of a second, preferred embodiment of an identification system according to the invention with an implant during the fixing to a bone fragment;
• FIG. 11: shows a sectional view along line11-11 inFIG. 10 and
• FIG. 12: shows a view similar toFIG. 11 during the detachment of the surgical data carrier from the implant.
DETAILED DESCRIPTION OF THE INVENTION
• A first, preferred embodiment of a surgical implantation system according to the invention is shown inFIG. 1 and given, altogether, thereference numeral10. Theimplantation system10 comprises animplant12 as well as a first, preferred embodiment of asurgical data carrier14 likewise according to the invention.
• Theimplant12 is designed as a surgical two-hole plate16 produced from titanium for connecting two bones and/or bone fragments. It comprises afirst attachment lobe18 to be connected to a first bone and/or bone fragment as well as asecond attachment lobe20 spaced therefore and to be connected to a second bone and/or bone fragment. Thefirst attachment lobe18 and thesecond attachment lobe20 havescrew holes22 and24, respectively, which can be penetrated by fixing means, such as, for example, bone screws which are not shown inFIG. 1, in order to connect the two-hole plate16 to the bone and/or bone fragment. Such a bone screw passing through a screw hole is shown inFIG. 10 described later on.
• Thefirst attachment lobe18 and thesecond attachment lobe20 are connected to one another via aweb26. This is of a flat design, like thefirst attachment lobe18 and thesecond attachment lobe20, so that the two-hole plate16 is, altogether, of a flat design and approximately defines a plate plane.
• Thedata carrier14, which forms theimplantation system10 together with theimplant12, is arranged on theweb26. It is produced in one piece from a material which can be sterilized as often as required in saturated steam. This can, for example, be a polymer material, such as, for example, polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyoxymethylene (POM), polytetrafluoroethylene (PTFE, Teflon) or the like.
• Acarrier element28 of thedata carrier14 is designed as acarrier plate30 with a square cross section in a plan view of the data carrier. Thecarrier plate30 has anupper side32 pointing away from the two-hole plate16 and anunderside34 pointing towards the two-hole plate16 and, in particular, the web26 (FIGS. 2 and 3). Thecarrier plate30 abuts on theweb26 via theunderside34.
• Theunderside34 is not flat because thecarrier plate30 has areas with different material thicknesses. It comprises a firstcarrier plate section36 as well as a secondcarrier plate section38 with identical material thicknesses which are formed on oppositely located sides of thecarrier plate30. The firstcarrier plate section36 and the secondcarrier plate section38 therefore represent carrier element sections of thecarrier element28. Between the firstcarrier plate section36 and the secondcarrier plate section38, thecarrier plate30 has a weakenedarea40 with a reduced material thickness in comparison with the firstcarrier plate section36 and the secondcarrier plate section38. The weakenedarea40 will be explained in greater detail further on.
• Thedata carrier14 is, altogether, of a symmetric design with respect to at least two planes of symmetry, the first of which extends at right angles to the plane defined by thecarrier plate30 and along the weakenedarea40 and the second of which extends at right angles to the plane defined by thecarrier plate30 and at right angles to the direction of the weakenedarea40 through the center thereof.
• Thedata carrier14 is connected to the two-hole plate16 via a connectingdevice42 formed on theunderside34 of thecarrier plate30. It comprises a first connectingelement44 which projects at right angles from theunderside34 at anedge area46 of the firstcarrier plate section36 as well as a second connectingelement48 which projects at right angles from theunderside34 at anedge area50 of the secondcarrier plate section38. Theedge areas46 and50 point towards the center of thecarrier plate30.
• The first connectingelement44 and the second connectingelement48 are designed asbars52 and54 extending parallel to the weakenedarea40 and limit between them, in sections, areceptacle56 for theimplant12 which is also limited in sections by theunderside34 of thecarrier plate30.
• Theimplant12 is held within thereceptacle56 by theweb26. Thebars52 and54 abut on theweb26 withside surfaces58 and60, respectively, which limit thereceptacle56 to the side along theweb26. Furthermore, thecarrier plate30 abuts partially on theweb26 with theunderside34. The weakenedarea40 corresponds to that area of thecarrier plate30, with which thecarrier plate30 abuts on theweb26. Theweb26 is in this way held in thereceptacle56 more or less in a form-locking manner. Thecarrier plate sections36 and38 are arranged on oppositely located sides of theweb26.
• A position of the connectingdevice42, in which theimplant12 is held at least partially in thereceptacle56, is designated as connecting position of the connectingdevice42.
• Securing members in the form ofprojections62 and64, respectively, are arranged at the ends of thebars52 and54 facing away from thecarrier plate30, these projections forming a recess for theweb26. They engage around theweb26 in the connecting position and secure it in thereceptacle56 in this way.
• Between theprojections62 and64, thereceptacle56 comprises aninsertion opening66, through which theweb26 can be introduced into thereceptacle56. Theinsertion opening66 is, at the same time, a removal opening, through which theweb26 can be withdrawn from thereceptacle56. The detachment of thedata carrier14 from theimplant12 will be explained further on.
• In further, preferred embodiments of a data carrier according to the invention, at least one connecting element of the connecting device can be designed, for example, as a snap-in element. In addition, at least one connecting element can be designed as a clamping element, whereby it is made possible for the implant to be clamped securely in the receptacle. Accordingly, the implant can be held in the receptacle in the connecting position preferably in a form-locking, force-locking or frictional manner.
• On itsupper side32, thedata carrier14 has adata storage device68 with astorage area70 which comprises part of the upper side32 (FIG. 1).Data72 for identifying and characterizing theimplant12 are deposited at thestorage area70. They can include, for example, the name of the producer, batch number, article number, serial number, type and size of the implant and the like. Thedata72 are cast directly onto thedata carrier14 during its production and protrude from thecarrier plate30 as relief-like writings74a,74b,74c.
• Thedata72 can be read optically, i.e., with the aid of an optical imaging device, in particular, the human eye. They can, therefore, be recognized by a user, such as, for example, a surgeon.
• Thedata carrier14 serves the purpose of describing, marking and identifying theimplant12 by means of thedata72. After theimplant12 has been inserted into the body of a patient, thedata carrier14 can be detached from theimplant12 as explained below and remain in the patient's file, for example, for documentation purposes so that it is possible to trace theimplant12 back.
• Thestorage area70 is arranged completely on thecarrier element28. However, it may also be provided for thestorage area70 to be arranged only partially on the carrier element, wherein it can, for example, also be partially arranged on the first connectingelement44 and/or on the second connectingelement48.
• Additional, preferred embodiments of a data carrier according to the invention comprise data storage devices, with which the data can be deposited, in contrast to the reliefs, in a different type of physical form, such as, for example, by way of embossing, attachment of an adhesive label or tag, lettering or printing on the surface or the like.
• Optical readability of the data can also be achieved by means of a mechanically operated, optical imaging device. The use of a bar code reader is mentioned as an example, with which bar codes can be read which are advantageously arranged on an adhesive label secured to thecarrier plate30.
• In the case of thedata carrier14, thedata storage device68 can also be of an electronic nature so that the data can be stored in an electronic manner and/or computed in the storage. In particular, it may be provided for the electronic data storage device to be read inductively and, therefore, without contact, possibly with the use of a transponder and particularly an RFID chip. An electronic RFID chip could preferably be arranged, for example, in thecarrier plate30.
• As already mentioned, thedata carrier14 is produced from a sterilizable plastic material. This has a thermal coefficient of expansion which is greater than the thermal coefficient of expansion of titanium, from which theimplant12 is produced. During the sterilization of theimplantation system10, agap76 is formed during heating between theweb26 and the sections limiting the receptacle56 (FIG. 3), i.e., the side surfaces58 and60, theprojections62 and64 and theunderside34, on account of the increased thermal coefficient of expansion. Consequently, it is possible to also sterilize the areas of theweb26 adjacent to these specified sections without it being necessary to separate thedata carrier14 from theimplant12 beforehand. This gives the implantation system10 a great user-friendly capability.
• Additional, preferred embodiments of an implantation system according to the invention are shown inFIGS. 4 to 7 and given thereference numerals80,85,90 and95, respectively.
• Theimplantation system80 comprises a square four-hole plate81 and adata carrier82 according to the invention which is of the same constructional design as thedata carrier14 and differs from it only as a result of the data identifying the four-hole plate81. Fourattachment lobes83a,83b,83cand83dform the “corners” of the four-hole plate81.
• In a similar way, theimplantation system85 comprises a T-shaped three-hole plate86 as well as adata carrier87 according to the invention which is of the same constructional design as thedata carrier14 and differs from thedata carrier14 as a result of the data identifying the three-hole plate86. Anattachment lobe88ais arranged at one end of the “long stroke” of the T and twoattachment lobes88band88care located at the ends of the “cross stroke” of the T.
• Theimplantation system90 comprises acover plate91 for a bore hole as well as adata carrier92 according to the invention which is of the same constructional design as thedata carrier14 and differs from thedata carrier14 as a result of the data identifying thecover plate91 for the bore hole. Thecover plate91 for the bore hole is of a star-shaped design and has sixattachment lobes93a,93b,93c,93d,93eand93fas well as acentral bore94.
• Theimplantation system95 comprises a two-hole plate96 which is of an identical design to the two-hole plate16 as well as adata carrier97 according to the invention. Thedata carrier97 is essentially of the same constructional design as thedata carrier14. Itscarrier plate98 does, however, have aplate section102 covering afirst attachment lobe100 of the two-hole plate96. In addition, thedata carrier97 differs from thedata carrier14 as a result of the data identifying the two-hole plate96.
• As already mentioned, thedata carrier14 can be detached from theimplant12. This is brought about in that the connectingdevice42 is transferred from the connecting position, in which theimplant12 is held in thereceptacle56, into a release position, in which thedata carrier14 can be detached from the implant. The transfer of the connectingdevice42 from the connecting position into the release position can be brought about as follows:
• As a result of forces acting on thecarrier plate30, in particular, on the firstcarrier plate section36 and on the secondcarrier plate section38, it is possible to move the firstcarrier plate section36 and the secondcarrier plate section38 relative one another.
• Thecarrier plate30 can, in particular, be curved because it has a reduced material thickness at the weakenedarea40 in comparison with the firstcarrier plate section36 and the secondcarrier plate section38. Consequently, the weakenedarea40 defines a section of thecarrier element28 with a greater deformability than the firstcarrier plate section36 and the secondcarrier plate section38. The weakenedarea40 forms, in particular, a film hinge, at which the firstcarrier element section36 and the secondcarrier element section38 can be pivoted relative to one another about apivot axis105 which extends along the weakenedarea40. As a result, the first connectingelement44 and the second connectingelement48 can be moved relative to one another and, in particular, in respective directions pointing away from theweb26. In this way, theinsertion opening66 of thereceptacle56 defined between theprojections62 and64 and thereceptacle56 can be enlarged.
• When theinsertion opening66 is sufficiently large, the connectingdevice42 is in a release position, in which thedata carrier14 can be detached from theimplant12 and moved away from it. In this respect, the transfer of the connectingdevice42 from the connecting position into the release position is possible without any forces acting on theimplant12. “Without any acting forces” need not require, in the present case, a complete lack of contact between thedata carrier14 and theimplant12. However, no contrary holding force acting on theimplant12 is required for the transfer of the connectingdevice42. As a result, thedata carrier14 offers a particularly good handling capability for a user, for example, a surgeon.
• Thedata carrier14 can, in particular, be detached from theimplant12 without any residue.
• Vice versa, the connectingdevice42 can be transferred from the release position into the connecting position without any forces acting on theimplant12. Thedata carrier14 is designed such that the connectingdevice42 automatically takes up the connecting position proceeding from the release position. The connecting position therefore defines a rest position of the connectingdevice42. As a result, it can be ensured that the detachment of thedata carrier14 from theimplant12 must be carried out intentionally by the user and so any unintentional separation ofdata carrier14 andimplant12 can be avoided to a great extent.
• The transfer of the connectingdevice42 from the connecting position into the release position and vice versa can take place manually by a user acting on thecarrier element28. It may, however, also be provided for this to take place with the aid of a tool. For this purpose, reference is made in the following toFIGS. 8 and 9.
• Thedata carrier14 according to the invention and ahandling device108 form a preferred embodiment of an identification system according to the invention for identifying and handling a medical implant, here theimplant12, this embodiment being shown inFIGS. 8 and 9 and given thereference numeral110. Theimplant12 and thedata carrier14 form the describedimplantation system10 according to the invention.
• Thehandling device108 comprises afirst tool element112 with a firstgripping arm114 and a secondgripping arm116 which can be brought into engagement with thecarrier element28. They are in engagement with thecarrier plate30, accessing thecarrier plate30 from the side thereof facing away from theweb26. The firstgripping arm114 and the secondgripping arm116, which are illustrated as being arranged symmetrically to one another with respect to the first plane of symmetry, have at their ends for this purpose concavecarrier element receptacles118 and120, respectively, in which the firstcarrier plate section36 and the secondcarrier plate section38, respectively, engage in sections. Thedata carrier14 and, with it, also theimplant12 held in thereceptacle56 can, therefore, be moved, transported, held or the like by means of thehandling device108 and, in particular, theimplant12 can be placed at its predetermined location.
• Asecond tool element122 of thehandling device108 is designed as aplunger124 which is arranged between the firstgripping arm114 and the secondgripping arm116 and is displaceable relative to them in the first plane of symmetry and at right angles to thecarrier plate30. If itsplunger head126 is brought into contact with thecarrier element28 as a result of abutment on the weakenedarea40 and theplunger124 is displaced relative to the firstgripping arm114 and the secondgripping arm116, thecarrier plate30 can be caused to curve as a result. In this respect, the firstcarrier plate section36 and the secondcarrier plate section38 pivot relative to one another about thepivot axis105 which extends along the weakenedarea40.
• Consequently, the first connectingelement44 and the second connectingelement48 are moved relative to one another in order to enlarge theinsertion opening66 and thereceptacle56 so that thedata carrier14 can be detached from the implant12 (FIG. 9). This means that the connectingdevice42 can be transferred from the connecting position into the release position by means of thehandling device108. Vice versa, the connectingdevice42 can also be transferred from the release position into the connecting position by means of thehandling device108. In both cases, this can take place without any forces acting on the implant.
• A further, preferred embodiment of an identification system according to the invention comprises ahandling device128 as well as a preferred embodiment of asurgical data carrier14′ according to the invention and is given thereference numeral130 inFIGS. 10 to 12.
• Thedata carrier14′ is essentially of the same constructional design as thedata carrier14 described above. In order to designate the features of thedata carrier14′, the reference numerals of the identical and/or functionally similar features of thedata carrier14 are, therefore, used with a prime sign added. Thedata carrier14′ differs from thedata carrier14 only due to the configuration of itscarrier element28′. This has, in a plan view, the shape of an irregular hexagon. Thedata carrier14′ forms, together with theimplant12 which is likewise illustrated inFIGS. 10 to 12, a preferred embodiment of asurgical implantation system10′ according to the invention.
• Thescrew hole24 of thesecond attachment lobe20 of theimplant12 has abone screw132 passing through it which is screwed by means of asurgical screw instrument134 to a bone fragment not illustrated in the drawings in order to secure the two-hole plate16 to it.
• Thehandling device128 has afirst tool element136 and asecond tool element138 which formarms140 and142, respectively, offorceps144, as which thehandling device128 is configured. Thearms140 and142 are illustrated as being arranged symmetrically to one another with respect to the first plane of symmetry of thedata carrier14′ and can be moved relative to one another, in particular, spread relative to one another.
• Thefirst arm140 and thesecond arm142 can be brought into engagement with thecarrier element28′ in that their ends pass throughtool element receptacles146 and148 in the form ofpassages150 and152, respectively, of the firstcarrier plate section36′ and the secondcarrier plate section38′, respectively. Thefirst arm140 and thesecond arm142 can be wedged in thepassages150 and152, respectively, merely as a result of slight spreading of the arms relative to one another and so thedata carrier14′ and, with it, theimplant12 can be moved, transported or the like.
• As a result of considerable spreading of thefirst arm140 and thesecond arm142 relative to one another, thecarrier plate30′ can be curved at its weakenedarea40′, wherein the firstcarrier plate section36′ and the secondcarrier plate section38′ are pivoted relative to one another about thepivot axis105′ which extends along the weakenedarea40. This enables the first connectingelement44′ and the second connectingelement48′ to be moved relative to one another (FIG. 12). As a result, theinsertion opening66′ and thereceptacle56′ can be enlarged as explained above and the connectingdevice42′ be transferred from the connecting position, in which theimplant12 is held in thereceptacle56′, into a release position, in which thedata carrier14′ can be detached from theimplant12, without any forces acting on theimplant12.

Claims (42)

1. Surgical data carrier for the identification of a medical implant, in particular, a surgical plate for the fixing of bones or bone fragments, comprising a carrier element and a connecting device with a receptacle for the insertion of at least part of the implant, wherein the connecting device is designed in such a manner that it is transferable from a connecting position, the implant being held in the receptacle in said connecting position, into a release position, the data carrier being detachable from the implant in said release position, without any forces acting on the implant.

2. Surgical data carrier as defined inclaim 1, wherein the receptacle is enlarged during the transfer of the connecting device from the connecting position into the release position.

3. Surgical data carrier as defined inclaim 1, wherein the connecting device is designed in such a manner that it is transferable from the release position into the connecting position without any forces acting on the implant.

4. Surgical data carrier as defined inclaim 1, wherein the connecting device is designed in such a manner that it takes up the connecting position automatically proceeding from the release position.

5. Surgical data carrier as defined inclaim 1, wherein the connecting device comprises at least one connecting element arranged on the carrier element, said connecting element limiting the receptacle at least in sections and interacting with the implant for the connection of the data carrier.

6. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element has a contact surface abutting on the implant in the connecting position.

7. Surgical data carrier as defined inclaim 5, wherein the connecting device comprises two or more connecting elements limiting the receptacle in sections.

8. Surgical data carrier as defined inclaim 7, wherein the two or more connecting elements are movable relative to one another.

9. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element is arranged or mounted on the carrier element so as to be movable.

10. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element is designed to be deformable at least in sections.

11. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element is designed to project from the carrier element.

12. Surgical data carrier as defined inclaim 1, wherein the carrier element limits the receptacle at least in sections.

13. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element is designed as a snap-in element.

14. Surgical data carrier as defined inclaim 5, wherein the at least one connecting element is designed as a clamping element.

15. Surgical data carrier as defined inclaim 1, wherein the connecting device has a securing member for securing the implant in the receptacle in the connecting position.

16. Surgical data carrier as defined inclaim 15, wherein the securing member is adapted to be brought into engagement with a receptacle comprised by the implant.

17. Surgical data carrier as defined inclaim 1, wherein the carrier element is deformable at least in sections such that the connecting device is transferable from the connecting position into the release position.

18. Surgical data carrier as defined inclaim 1, wherein the carrier element comprises a first carrier element section and a second carrier element section movable relative to one another.

19. Surgical data carrier as defined inclaim 18, wherein the carrier element has a weakened area arranged between the first carrier element section and the second carrier element section, said weakened area having a greater deformability than at least one of the two carrier element sections.

20. Surgical data carrier as defined inclaim 18, wherein the carrier element comprises at least one tool element receptacle for a handling device for the data carrier on the first carrier element section and/or on the second carrier element section.

21. Surgical data carrier as defined inclaim 20, wherein the at least one receptacle is designed as a passage of the carrier element.

22. Surgical data carrier as defined inclaim 1, wherein the carrier element is of a plate-like design.

23. Surgical data carrier as defined inclaim 1, wherein the data carrier comprises a data storage device for storing data able to identify the implant.

24. Surgical data carrier as defined inclaim 23, wherein the data storage device is adapted to be read in a non-contact manner.

25. Surgical data carrier as defined inclaim 23, wherein the data storage device is arranged at least partially on the carrier element.

26. Surgical data carrier as defined inclaim 1, wherein the data carrier is produced at least partially from a plastic material.

27. Surgical data carrier as defined inclaim 1, wherein the data carrier is produced at least partially from a shape memory metal alloy.

28. Surgical data carrier as defined inclaim 1, wherein the data carrier is produced from a sterilizable material.

29. Surgical data carrier as defined inclaim 1, wherein the data carrier is produced at least partially from a material having a thermal-coefficient of expansion greater than the thermal coefficient of expansion of titanium or that of an alloy having titanium as its main component.

30. Surgical data carrier as defined inclaim 1, wherein the data carrier is produced from a resorbable material.

31. Surgical data carrier as defined inclaim 1, wherein the data carrier is detachable from the implant free from residue.

32. Surgical data carrier as defined inclaim 1, wherein the data carrier is designed in one piece.

33. Surgical implantation system having at least one medical implant, in particular, a surgical plate for the fixing of bones or bone fragments as well as a surgical data carrier detachably connectable to the implant for the identification of the implant, comprising a carrier element and a connecting device having a receptacle for the insertion of at least part of the implant, wherein the connecting device is designed in such a manner that it is transferable from a connecting position, the implant being held in the receptacle in said connecting position, into a release position, the data carrier being detachable from the implant in said release position, without any forces acting on the implant.

34. Surgical implantation system as defined inclaim 33, wherein the connecting device is designed in such a manner that it is transferable from the release position into the connecting position without any forces acting on the implant.

35. Identification system for identifying and handling a medical implant, in particular, a surgical plate for the fixing of bones or bone fragments, said system having a surgical data carrier for the identification of the implant, said data carrier comprising a carrier element and a connecting device having a receptacle for the insertion of at least part of the implant, wherein the connecting device is designed in such a manner that it is transferable from a connecting position, the implant being held in the receptacle in said connecting position, into a release position, the data carrier being detachable from the implant in said release position, without any forces acting on the implant, and wherein the identification system comprises a handling device for transferring the connecting device from the connecting position into the release position.

36. Identification system as defined inclaim 35, wherein the connecting device is designed in such a manner that it is transferable from the release position into the connecting position without any forces acting on the implant.

37. Identification system as defined inclaim 35, wherein the handling device has a first tool element as well as a second tool element movable relative to it, each tool element being adapted to be brought into engagement with the carrier element or to abut on it.

38. Identification system as defined inclaim 37, wherein during use of the handling device the first tool element and the second tool element are able to engage in tool element receptacles arranged in the first carrier element section and second carrier element section, respectively, and designed to correspond to the first and second tool elements, respectively.

39. Identification system as defined inclaim 37, wherein the first tool element and/or the second tool element each have at least one carrier element receptacle for engagement of the first carrier element section and the second carrier element section, respectively, in sections during use of the handling device.

40. Identification system as defined inclaim 37, wherein the first tool element and/or the second tool element are designed as arms of forceps.

41. Identification system as defined inclaim 37, wherein the first tool element and/or the second tool element is designed as a plunger.

42. Identification system as defined inclaim 37, wherein the first tool element and the second tool element are displaceable and/or pivotable relative to one another.

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