US20080230421A1

US20080230421A1 - Surgical data carrier

Info

Publication number: US20080230421A1
Application number: US12/070,052
Authority: US
Inventors: Thomas Pleil; Markus Nesper; Dirk Schauer; Dieter Weisshaupt
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2007-02-28
Filing date: 2008-02-13
Publication date: 2008-09-25
Also published as: DE102007011086B3; JP2008253740A

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 in German 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 line 2-2 in FIG. 1;

FIG. 3: shows a view similar to FIG. 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 to FIG. 2;

FIG. 9: shows a view similar to FIG. 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 line 11-11 in FIG. 10 and

FIG. 12: shows a view similar to FIG. 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 in FIG. 1 and given, altogether, the reference numeral 10. The implantation system 10 comprises an implant 12 as well as a first, preferred embodiment of a surgical data carrier 14 likewise according to the invention.
The implant 12 is designed as a surgical two-hole plate 16 produced from titanium for connecting two bones and/or bone fragments. It comprises a first attachment lobe 18 to be connected to a first bone and/or bone fragment as well as a second attachment lobe 20 spaced therefore and to be connected to a second bone and/or bone fragment. The first attachment lobe 18 and the second attachment lobe 20 have screw holes 22 and 24, respectively, which can be penetrated by fixing means, such as, for example, bone screws which are not shown in FIG. 1, in order to connect the two-hole plate 16 to the bone and/or bone fragment. Such a bone screw passing through a screw hole is shown in FIG. 10 described later on.
The first attachment lobe 18 and the second attachment lobe 20 are connected to one another via a web 26. This is of a flat design, like the first attachment lobe 18 and the second attachment lobe 20, so that the two-hole plate 16 is, altogether, of a flat design and approximately defines a plate plane.
The data carrier 14, which forms the implantation system 10 together with the implant 12, is arranged on the web 26. 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.
A carrier element 28 of the data carrier 14 is designed as a carrier plate 30 with a square cross section in a plan view of the data carrier. The carrier plate 30 has an upper side 32 pointing away from the two-hole plate 16 and an underside 34 pointing towards the two-hole plate 16 and, in particular, the web 26 (FIGS. 2 and 3). The carrier plate 30 abuts on the web 26 via the underside 34.
The underside 34 is not flat because the carrier plate 30 has areas with different material thicknesses. It comprises a first carrier plate section 36 as well as a second carrier plate section 38 with identical material thicknesses which are formed on oppositely located sides of the carrier plate 30. The first carrier plate section 36 and the second carrier plate section 38 therefore represent carrier element sections of the carrier element 28. Between the first carrier plate section 36 and the second carrier plate section 38, the carrier plate 30 has a weakened area 40 with a reduced material thickness in comparison with the first carrier plate section 36 and the second carrier plate section 38. The weakened area 40 will be explained in greater detail further on.
The data carrier 14 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 the carrier plate 30 and along the weakened area 40 and the second of which extends at right angles to the plane defined by the carrier plate 30 and at right angles to the direction of the weakened area 40 through the center thereof.
The data carrier 14 is connected to the two-hole plate 16 via a connecting device 42 formed on the underside 34 of the carrier plate 30. It comprises a first connecting element 44 which projects at right angles from the underside 34 at an edge area 46 of the first carrier plate section 36 as well as a second connecting element 48 which projects at right angles from the underside 34 at an edge area 50 of the second carrier plate section 38. The edge areas 46 and 50 point towards the center of the carrier plate 30.
The first connecting element 44 and the second connecting element 48 are designed as bars 52 and 54 extending parallel to the weakened area 40 and limit between them, in sections, a receptacle 56 for the implant 12 which is also limited in sections by the underside 34 of the carrier plate 30.
The implant 12 is held within the receptacle 56 by the web 26. The bars 52 and 54 abut on the web 26 with side surfaces 58 and 60, respectively, which limit the receptacle 56 to the side along the web 26. Furthermore, the carrier plate 30 abuts partially on the web 26 with the underside 34. The weakened area 40 corresponds to that area of the carrier plate 30, with which the carrier plate 30 abuts on the web 26. The web 26 is in this way held in the receptacle 56 more or less in a form-locking manner. The carrier plate sections 36 and 38 are arranged on oppositely located sides of the web 26.
A position of the connecting device 42, in which the implant 12 is held at least partially in the receptacle 56, is designated as connecting position of the connecting device 42.
Securing members in the form of projections 62 and 64, respectively, are arranged at the ends of the bars 52 and 54 facing away from the carrier plate 30, these projections forming a recess for the web 26. They engage around the web 26 in the connecting position and secure it in the receptacle 56 in this way.
Between the projections 62 and 64, the receptacle 56 comprises an insertion opening 66, through which the web 26 can be introduced into the receptacle 56. The insertion opening 66 is, at the same time, a removal opening, through which the web 26 can be withdrawn from the receptacle 56. The detachment of the data carrier 14 from the implant 12 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 its upper side 32, the data carrier 14 has a data storage device 68 with a storage area 70 which comprises part of the upper side 32 (FIG. 1). Data 72 for identifying and characterizing the implant 12 are deposited at the storage area 70. 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. The data 72 are cast directly onto the data carrier 14 during its production and protrude from the carrier plate 30 as relief- like writings 74 a, 74 b, 74 c.
The data 72 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.
The data carrier 14 serves the purpose of describing, marking and identifying the implant 12 by means of the data 72. After the implant 12 has been inserted into the body of a patient, the data carrier 14 can be detached from the implant 12 as explained below and remain in the patient's file, for example, for documentation purposes so that it is possible to trace the implant 12 back.
The storage area 70 is arranged completely on the carrier element 28. However, it may also be provided for the storage area 70 to be arranged only partially on the carrier element, wherein it can, for example, also be partially arranged on the first connecting element 44 and/or on the second connecting element 48.
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 the carrier plate 30.
In the case of the data carrier 14, the data storage device 68 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 the carrier plate 30.
As already mentioned, the data carrier 14 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 the implant 12 is produced. During the sterilization of the implantation system 10, a gap 76 is formed during heating between the web 26 and the sections limiting the receptacle 56 (FIG. 3), i.e., the side surfaces 58 and 60, the projections 62 and 64 and the underside 34, on account of the increased thermal coefficient of expansion. Consequently, it is possible to also sterilize the areas of the web 26 adjacent to these specified sections without it being necessary to separate the data carrier 14 from the implant 12 beforehand. This gives the implantation system 10 a great user-friendly capability.
Additional, preferred embodiments of an implantation system according to the invention are shown in FIGS. 4 to 7 and given the reference numerals 80, 85, 90 and 95, respectively.
The implantation system 80 comprises a square four-hole plate 81 and a data carrier 82 according to the invention which is of the same constructional design as the data carrier 14 and differs from it only as a result of the data identifying the four-hole plate 81. Four attachment lobes 83 a, 83 b, 83 c and 83 d form the “corners” of the four-hole plate 81.
In a similar way, the implantation system 85 comprises a T-shaped three-hole plate 86 as well as a data carrier 87 according to the invention which is of the same constructional design as the data carrier 14 and differs from the data carrier 14 as a result of the data identifying the three-hole plate 86. An attachment lobe 88 a is arranged at one end of the “long stroke” of the T and two attachment lobes 88 b and 88 c are located at the ends of the “cross stroke” of the T.
The implantation system 90 comprises a cover plate 91 for a bore hole as well as a data carrier 92 according to the invention which is of the same constructional design as the data carrier 14 and differs from the data carrier 14 as a result of the data identifying the cover plate 91 for the bore hole. The cover plate 91 for the bore hole is of a star-shaped design and has six attachment lobes 93 a, 93 b, 93 c, 93 d, 93 e and 93 f as well as a central bore 94.
The implantation system 95 comprises a two-hole plate 96 which is of an identical design to the two-hole plate 16 as well as a data carrier 97 according to the invention. The data carrier 97 is essentially of the same constructional design as the data carrier 14. Its carrier plate 98 does, however, have a plate section 102 covering a first attachment lobe 100 of the two-hole plate 96. In addition, the data carrier 97 differs from the data carrier 14 as a result of the data identifying the two-hole plate 96.
As already mentioned, the data carrier 14 can be detached from the implant 12. This is brought about in that the connecting device 42 is transferred from the connecting position, in which the implant 12 is held in the receptacle 56, into a release position, in which the data carrier 14 can be detached from the implant. The transfer of the connecting device 42 from the connecting position into the release position can be brought about as follows:
As a result of forces acting on the carrier plate 30, in particular, on the first carrier plate section 36 and on the second carrier plate section 38, it is possible to move the first carrier plate section 36 and the second carrier plate section 38 relative one another.
The carrier plate 30 can, in particular, be curved because it has a reduced material thickness at the weakened area 40 in comparison with the first carrier plate section 36 and the second carrier plate section 38. Consequently, the weakened area 40 defines a section of the carrier element 28 with a greater deformability than the first carrier plate section 36 and the second carrier plate section 38. The weakened area 40 forms, in particular, a film hinge, at which the first carrier element section 36 and the second carrier element section 38 can be pivoted relative to one another about a pivot axis 105 which extends along the weakened area 40. As a result, the first connecting element 44 and the second connecting element 48 can be moved relative to one another and, in particular, in respective directions pointing away from the web 26. In this way, the insertion opening 66 of the receptacle 56 defined between the projections 62 and 64 and the receptacle 56 can be enlarged.
When the insertion opening 66 is sufficiently large, the connecting device 42 is in a release position, in which the data carrier 14 can be detached from the implant 12 and moved away from it. In this respect, the transfer of the connecting device 42 from the connecting position into the release position is possible without any forces acting on the implant 12. “Without any acting forces” need not require, in the present case, a complete lack of contact between the data carrier 14 and the implant 12. However, no contrary holding force acting on the implant 12 is required for the transfer of the connecting device 42. As a result, the data carrier 14 offers a particularly good handling capability for a user, for example, a surgeon.
The data carrier 14 can, in particular, be detached from the implant 12 without any residue.
Vice versa, the connecting device 42 can be transferred from the release position into the connecting position without any forces acting on the implant 12. The data carrier 14 is designed such that the connecting device 42 automatically takes up the connecting position proceeding from the release position. The connecting position therefore defines a rest position of the connecting device 42. As a result, it can be ensured that the detachment of the data carrier 14 from the implant 12 must be carried out intentionally by the user and so any unintentional separation of data carrier 14 and implant 12 can be avoided to a great extent.
The transfer of the connecting device 42 from the connecting position into the release position and vice versa can take place manually by a user acting on the carrier element 28. 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 to FIGS. 8 and 9.
The data carrier 14 according to the invention and a handling device 108 form a preferred embodiment of an identification system according to the invention for identifying and handling a medical implant, here the implant 12, this embodiment being shown in FIGS. 8 and 9 and given the reference numeral 110. The implant 12 and the data carrier 14 form the described implantation system 10 according to the invention.
The handling device 108 comprises a first tool element 112 with a first gripping arm 114 and a second gripping arm 116 which can be brought into engagement with the carrier element 28. They are in engagement with the carrier plate 30, accessing the carrier plate 30 from the side thereof facing away from the web 26. The first gripping arm 114 and the second gripping arm 116, 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 concave carrier element receptacles 118 and 120, respectively, in which the first carrier plate section 36 and the second carrier plate section 38, respectively, engage in sections. The data carrier 14 and, with it, also the implant 12 held in the receptacle 56 can, therefore, be moved, transported, held or the like by means of the handling device 108 and, in particular, the implant 12 can be placed at its predetermined location.
A second tool element 122 of the handling device 108 is designed as a plunger 124 which is arranged between the first gripping arm 114 and the second gripping arm 116 and is displaceable relative to them in the first plane of symmetry and at right angles to the carrier plate 30. If its plunger head 126 is brought into contact with the carrier element 28 as a result of abutment on the weakened area 40 and the plunger 124 is displaced relative to the first gripping arm 114 and the second gripping arm 116, the carrier plate 30 can be caused to curve as a result. In this respect, the first carrier plate section 36 and the second carrier plate section 38 pivot relative to one another about the pivot axis 105 which extends along the weakened area 40.
Consequently, the first connecting element 44 and the second connecting element 48 are moved relative to one another in order to enlarge the insertion opening 66 and the receptacle 56 so that the data carrier 14 can be detached from the implant 12 (FIG. 9). This means that the connecting device 42 can be transferred from the connecting position into the release position by means of the handling device 108. Vice versa, the connecting device 42 can also be transferred from the release position into the connecting position by means of the handling device 108. 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 a handling device 128 as well as a preferred embodiment of a surgical data carrier 14′ according to the invention and is given the reference numeral 130 in FIGS. 10 to 12.
The data carrier 14′ is essentially of the same constructional design as the data carrier 14 described above. In order to designate the features of the data carrier 14′, the reference numerals of the identical and/or functionally similar features of the data carrier 14 are, therefore, used with a prime sign added. The data carrier 14′ differs from the data carrier 14 only due to the configuration of its carrier element 28′. This has, in a plan view, the shape of an irregular hexagon. The data carrier 14′ forms, together with the implant 12 which is likewise illustrated in FIGS. 10 to 12, a preferred embodiment of a surgical implantation system 10′ according to the invention.
The screw hole 24 of the second attachment lobe 20 of the implant 12 has a bone screw 132 passing through it which is screwed by means of a surgical screw instrument 134 to a bone fragment not illustrated in the drawings in order to secure the two-hole plate 16 to it.
The handling device 128 has a first tool element 136 and a second tool element 138 which form arms 140 and 142, respectively, of forceps 144, as which the handling device 128 is configured. The arms 140 and 142 are illustrated as being arranged symmetrically to one another with respect to the first plane of symmetry of the data carrier 14′ and can be moved relative to one another, in particular, spread relative to one another.
The first arm 140 and the second arm 142 can be brought into engagement with the carrier element 28′ in that their ends pass through tool element receptacles 146 and 148 in the form of passages 150 and 152, respectively, of the first carrier plate section 36′ and the second carrier plate section 38′, respectively. The first arm 140 and the second arm 142 can be wedged in the passages 150 and 152, respectively, merely as a result of slight spreading of the arms relative to one another and so the data carrier 14′ and, with it, the implant 12 can be moved, transported or the like.
As a result of considerable spreading of the first arm 140 and the second arm 142 relative to one another, the carrier plate 30′ can be curved at its weakened area 40′, wherein the first carrier plate section 36′ and the second carrier plate section 38′ are pivoted relative to one another about the pivot axis 105′ which extends along the weakened area 40. This enables the first connecting element 44′ and the second connecting element 48′ to be moved relative to one another (FIG. 12). As a result, the insertion opening 66′ and the receptacle 56′ can be enlarged as explained above and the connecting device 42′ be transferred from the connecting position, in which the implant 12 is held in the receptacle 56′, into a release position, in which the data carrier 14′ can be detached from the implant 12, without any forces acting on the implant 12.

Claims

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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 5, wherein the connecting device comprises two or more connecting elements limiting the receptacle in sections.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

29. Surgical data carrier as defined in claim 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 in claim 1, wherein the data carrier is produced from a resorbable material.

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

32. Surgical data carrier as defined in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 37, wherein the first tool element and/or the second tool element are designed as arms of forceps.

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

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