Implant template and implant template system
The implant template system addresses the complexity and cost issues of existing systems by using a flat, biocompatible carrier element with a two-dimensional implant view and through-view area, allowing for precise and cost-effective determination of optimal implant sizes and shapes for patient anatomy.
Patent Information
- Application Number
- DE102023134668
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2023-12-11
- Publication Date
- 2025-03-13
- Estimated Expiration
- 2043-12-11
AI Technical Summary
Existing implant template systems are complex and costly to produce, requiring multiple sizes and shapes, and must be sterile, making them challenging to determine the optimal size and shape of an implant for a patient's physiology.
An implant template system comprising a carrier element with a two-dimensional implant view and a through-view area, allowing for direct comparison with the patient's physiological situation, and made from a flat, biocompatible material that can be easily sterilized and adapted to different body structures.
Enables easy, cost-effective, and precise determination of the optimal implant size and shape by allowing direct comparison with the patient's anatomy, reducing the need for complex three-dimensional structures and minimizing production and sterilization costs.
Smart Images

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Abstract
Description
[0001] The present invention relates to an implant template.
[0002] Furthermore, the present invention relates to an implant template system comprising at least two implant templates.
[0003] Before implanting an implant into the body of a human or animal patient, it is common practice to introduce one or more trial implants to the site where the actual implant is to be placed, in order to determine, in particular, the shape and / or size of the implant to be inserted. It is especially common to place the trial implant, which corresponds in shape and size to the final implant, precisely where the implant is to be positioned. Size determination is necessary for virtually all types of implants, whether they are implants that are fixed to the spine as replacements for vertebral bodies or intervertebral discs, or also for knee or hip joint prostheses.
[0004] To determine the optimal size and shape, adapted to the patient's physiology, as described, trial implants in various shapes and / or sizes must be provided. These are complex and therefore expensive to manufacture. Furthermore, they must be sterile for size and shape determination on the patient.
[0005] DE 10 2006 031 808 A1 discloses a method for determining and defining the drill channel for a dental implant, as well as a drilling template for carrying out the method. A simplified size measuring device is described in DE 60 2004 011 420 T2. A template system for the spine and a method for using the system are disclosed.
[0006] It is therefore a particular object of the present invention to provide a template and a template system with which a suitable implant for the treatment of the patient can be easily determined.
[0007] This problem is solved according to the invention by an implant template comprising a support element with a front and a back, wherein the support element is made of a flat material, wherein the support element carries or has at least one two-dimensional implant view of an implant and wherein the support element has at least one see-through area which allows a view through the support element.
[0008] With such an implant template, it is easy to determine the required size and / or shape of an implant to fulfill the desired function in a patient's body. This type of implant template can be positioned precisely at or near the implantation site. The two-dimensional view of the implant, for example, a side view or a top view, can then be directly compared with the patient's physiological situation. The at least one viewing window allows the user to clearly see the surgical site and thus the physiological situation in the patient's body, enabling them to decide whether the implant, whose two-dimensional view is displayed on the template, is suitable for the planned treatment in terms of shape and / or size, and therefore for implantation.Such an implant template is particularly easy and cost-effective to produce because a flat material is used as the support element. Therefore, it is not necessary to create a three-dimensional structure, for example, in the form of known trial implants, that fully corresponds to the final implant to be implanted. Instead, only a template with at least one, and in particular only one, two-dimensional view of the implant to be implanted is provided to determine its optimal size for the patient by comparison with the implant view shown on the template. Consequently, to determine the size and / or shape of the implant to be implanted, it is not absolutely necessary to prepare the surgical site for the final implantation procedure, as the implant template does not need to be positioned in the final implantation position.Rather, it can simply be guided or applied to the patient's body structures, such as bone structures. A proposed implant template is also particularly easy to handle. Furthermore, by providing several such implant templates, depicting views of implants of varying sizes and / or shapes, and by comparing the physiological situation in the patient's body with these templates, the optimal size and / or shape of the implant to be implanted can be determined easily. Moreover, the implant template, being made of a flat material, can be inserted into the patient's body quickly and easily through an opening that is typically smaller than the one required for inserting the implant itself.In one embodiment, the support element can be larger than the two-dimensional view of the implant. For example, one or more holding areas can be provided for handling the implant template.
[0009] The at least one viewing area can be easily formed by creating a perforation or a translucent or transparent support element area. Both a perforation and a transparent support element area allow direct visibility, particularly of body structures behind the implant template. For example, the distances between adjacent vertebrae in a patient's spine can be viewed and measured through such viewing areas. A translucent support element area in this sense is partially transparent. In contrast to complete transparency, referred to as transparent in this application, a translucent support element area is understood as semi-transparent. The terms image-transparent, view-transparent, and see-through are used synonymously with transparent below.Translucent elements commonly used in everyday life are, for example, frosted glass or frosted glass or plastic sheets, which prevent direct visibility but allow light to pass through. Translucent areas of the support element also allow the visualization of underlying structures, provided such an area is positioned close enough to the patient's specific body structure. In particular, the design of translucent areas for the implant template ensures that accurate and reliable measurement and comparison of the two-dimensional implant view on the support element with a physiological structure is only possible when the implant template is positioned close enough to, and in particular, in contact with, the physiological structure.This allows for highly accurate measurement of physiological structures, as parallax errors are virtually eliminated. One or more openings in the support element can also be used as holding or handling elements for gripping or manipulating the implant template. This is particularly advantageous when the contour or width of the implant template corresponds to the width or contour of the two-dimensional implant view. In this design, there are no retaining tabs or areas protruding from the support element beyond the implant view for handling the implant template. This can be the case, for example, with an implant in the form of a cervical plate.For example, a handling instrument with at least one handling element, such as tweezers with their two free ends, which thus form two handling elements, can be used to engage suitable openings in the implant template and the implant template can be handled safely in this way - even without retaining tabs.
[0010] Furthermore, it can be advantageous if the implant view is at least partially radiopaque. This allows the user, in particular, to recognize the implant view even under radiographic guidance in relation to the patient's bone, i.e., when they do not have a direct view of the implant template. The implant view, or the markings defining it, can be designed to be visible on radiographs. This can be achieved, for example, by using a metallic ink to apply the two-dimensional implant view, or by constructing the implant template from a radiopaque, or at least partially radiopaque, carrier element produced by etching or waterjet cutting. Specifically, the flat material from which the carrier element is formed can be radiopaque but coated with a radiopaque layer.To create a two-dimensional view of the implant, the coating can then be removed, for example, by etching or water jet treatment. Preferably, one or more implant perforations, such as screw holes on the depicted implant, are made visible in the X-ray view, for example, by increasing or decreasing the amount of radiopaque material from which the implant template is formed.
[0011] It is advantageous if the implant view defines an inner and / or outer contour and if at least one transparent area is located adjacent to or formed by this inner and / or outer contour. This design makes it possible, in particular, to optimally determine the size and / or shape of the implant to be implanted by comparing the inner and / or outer contour with the physiological situation in the patient's body.
[0012] It is advantageous if the implant view includes at least one implant perforation. This does not necessarily mean that the supporting element must also have a perforation in the area of the implant perforation. Nor is a transparent area required in the area of the at least one implant perforation. However, it is beneficial if a perforation in the supporting element or some other type of transparent area is present or provided in the area of the implant perforation. This allows, in particular, the use of internal contours of the implant view when taking measurements on the patient's body.
[0013] Preferably, the at least one implant perforation forms the at least one viewing area. This makes it possible, in particular, to observe and, if necessary, measure a physiological situation in the patient's body through the implant template in the area of the at least one implant perforation.
[0014] Advantageously, at least one implant perforation includes a screw hole or a fixation hole. This perforation, shown in the two-dimensional implant view on the support element, serves to receive a screw or other fastening element in the implant intended for permanent or final implantation. This design allows, in particular, verification of whether the implant shown on the support element is suitable for fixation in the patient's body. Specifically, it allows verification of whether sufficient bone substance is present in the area of the implant perforation to anchor a fastening element.
[0015] The implant template can be formed simply and cost-effectively if the support element is plate- or disc-shaped. The support element, formed from flat material, can in principle be any shape, for example, round, oval, polygonal, and especially rectangular or trapezoidal. In particular, the support element can have a shape that corresponds to or is geometrically similar to the two-dimensional view of the implant.
[0016] According to a preferred embodiment, the support element may have a thickness defined by the distance between the front and back surfaces, and this thickness may be at most 3 mm. In particular, the thickness may be at most 1 mm. Support elements with a thickness within the specified range can be provided in a dimensionally stable manner, so that the implant template does not deform undesirably when applied to a patient's own body structure, which would make measuring body structures more difficult.
[0017] Preferably, the thickness is at least 0.05 mm. In particular, it can be at least 0.5 mm. It is therefore also possible to form a support element from a thin film. Dimensional stability of the support is not absolutely necessary.
[0018] To minimize the risk of rejection in the patient's body, it is advantageous for the implant template to be made of one or more biocompatible materials. For example, the carrier element can be made of a first biocompatible material. The two-dimensional implant view can be made of another biocompatible material, such as a suitable biocompatible printing ink or a biocompatible coating material, to apply the implant view to the carrier element. Alternatively, the two-dimensional implant view can be formed from a flat metallic material and applied to the carrier element.
[0019] Advantageously, the carrier element is made of a biocompatible carrier material. This helps to prevent unwanted rejection reactions in the patient's body when the carrier element comes into contact with body tissue.
[0020] The implant template can be produced simply and cost-effectively if the support element is made of a plastic. In particular, it can be made of polymethyl methacrylate (PMMA), glycol-modified polyethylene terephthalate (PETG), and / or polypropylene (PP).
[0021] Preferably, the support element is made of a transparent or translucent material. This design has the particular advantage that a see-through area is automatically formed on the support element wherever no two-dimensional implant view is applied or arranged. The two-dimensional implant view can be opaque, making it impermeable to electromagnetic radiation in the visible spectral range and / or X-rays. Thus, the two-dimensional implant view obscures an area of the body's own structures when approached, an area which corresponds precisely to the size and / or shape of the implant to be implanted in the depicted two-dimensional implant view.
[0022] For optimal handling and measurement of the body's own structures to determine the size and / or shape of an implant to be implanted, it is advantageous if the implant view shows a top view of one side of the implant. Preferably, this is precisely the implant view that is visible after implantation on the implant template.
[0023] The implant template can be created simply and cost-effectively by printing or engraving the implant view onto the carrier element, or by laser marking or using a thin metal stamping. For example, the implant view can be on the front of the carrier element. Optionally, it can also be on the back of the carrier element, either alternatively or additionally. However, this is not mandatory. It is sufficient to have the two-dimensional implant view on either the front or the back.
[0024] It is advantageous if the back of the support element has a translucent matte finish. This design gives the support element the translucent property described above. If the implant template is not brought close enough to a body structure, the user of the implant template cannot see the body structure through the support element, or at best only very diffusely. The body structure only becomes sufficiently visible when the support element is brought close enough to the body structure, and especially when it is in contact with it. Before the back is matted to make it translucent, the support element can, for example, initially be made from a transparent material. This also makes it possible to make only certain parts of the support element translucent. In this way, areas that are transparent can be created, as well as areas that are translucent.
[0025] To ensure the implant template can be applied to non-flat body structures, it is advantageous for the support element to be flexibly deformable. This allows it to be optimally positioned on one- or multi-dimensionally curved body structures for measurement purposes.
[0026] Preferably, the support element is curved to match the depicted implant. Such a support element is still made of a flat material. However, this material is deformed to match the depicted implant in order to enable optimal attachment to non-planar body structures.
[0027] To allow the implant template to be individually adapted to non-planar body structures, it is advantageous if the support element is plastically deformable. This has the particular advantage that not only is the support element deformable, but it also retains the shape assumed through deformation, especially bending, particularly until the task of the implant template—namely, measuring a body structure—has been fulfilled.
[0028] For handling the implant template, it is particularly advantageous if it includes at least one retention element for holding the template. Specifically, this retention element can be designed to be held with a holding instrument. For example, forceps or needle holders can be used as holding instruments. It is advantageous if the retention element is located or designed outside the support element covered by the two-dimensional view of the implant. This allows the implant template to be held without negatively affecting the dimensions of a patient's body structure with the implant template.
[0029] Advantageously, at least one retention element is designed as a support element area without a two-dimensional view of the implant. Therefore, the implant template can be grasped and held by the support element area without seeing the implant, in order to position it against a patient's body structure. In particular, the implant view is not obscured when using a holding instrument.
[0030] For handling the implant template, it is advantageous if at least one retaining element projects from the support element. In particular, it can project in a plane defined by the support element in its initial position, before the implant template is deformed, for example. Specifically, this plane can be defined by the undeformed flat material from which the support element is formed.
[0031] Preferably, the at least one retaining element is formed integrally with the support element. In particular, it is formed from the flat material. For example, the support element with the retaining element can be cut or punched out of a flat material.
[0032] The implant template is easy and safe to handle if at least one retention element is designed as a tab projecting from the support element. Such a tab can, in principle, have any shape. In particular, it can be polygonal, for example rectangular or square. It can also be semicircular or semi-oval.
[0033] To further improve the handling of the implant template, it is advantageous if the at least one retention element is deformable relative to the support element, particularly bendable. For example, the at least one retention element can be bent relative to the support element if it is formed in one piece from a flat material. This allows the user to easily and reliably hold the template with a suitable holding instrument using the bent retention element, which forms a retention plane perpendicular to the plane defined by the support element. Such a retention element, for example in the form of a retaining tab, can also be advantageous for assessing specific position points, such as screw holes on the depicted implant – including the screw angle – in a lateral radiographic view.For example, the retaining element can be made of a metallic material and bent in the area of the screw holes of the implant at an angle that corresponds to a possible screw entry angle into the respective screw holes on the implant shown.
[0034] It is advantageous if the at least one retaining element and the support element enclose a holding angle in a handling position, and if the holding angle is in a range of 0° to approximately 120°. In particular, it can be approximately 90°. A user can, for example, bend the retaining element relative to the support element so that they can guide the implant template to a body structure, such as one or more bones, in the desired manner with one hand or, for example, a holding instrument.
[0035] Furthermore, it is advantageous if the support element has at least one bending zone that allows deformation of the support element, and if the at least one retaining element is arranged or designed outside the bending zone. In this way, it can be ensured in particular that the at least one retaining element cannot negatively affect a property of the support element relating to its deformation, especially its bending.
[0036] According to a further preferred embodiment, the carrier element can be provided to carry, have, or include at least one further implant-specific piece of information. This enables a user not only to recognize and use the two-dimensional view of the implant for measurement purposes, but also, for example, information regarding size, implant type, or the like.
[0037] It is advantageous if the implant-specific information includes or specifies the size, length, and / or article number of the implant shown. For example, once a user has identified the appropriate implant using the implant template, they can immediately read all, or at least some, of the implant-specific information directly from the template. Therefore, no additional brochures, product information, or similar materials are needed to select the desired implant for implantation after using the template.
[0038] Ideally, the support element incorporates or includes at least one measuring scale. This allows the implant template to directly measure or assess the distances between a patient's body structures relative to one another. A measuring scale can also be used to assess or precisely determine the implant's orientation within the body. For example, with a spinal implant, the distances between the implant and an adjacent intervertebral disc can be checked and assessed, and in some cases, even measured precisely.
[0039] It is advantageous if the measuring scale is in the form of a millimeter scale. This allows a user to assess and, if necessary, measure the distance between a patient's own bodily structures with sufficient accuracy.
[0040] It is advantageous if the at least one retaining element is arranged or formed adjacent to or near the measuring scale, particularly in an extension thereof. In particular, the at least one retaining element can thus be arranged in such a way that it cannot negatively affect a property of the support element, namely its tendency to bend.
[0041] To prevent the introduction of germs into the patient's body during implant placement, it is advantageous for the implant template to be sterilizable. Specifically, it can be sterilized by exposure to a gas, electromagnetic radiation, particle radiation, or hot steam. A sterilizable implant template can be provided sterile for a single use, for example, in sterile packaging, which can then be opened by a user in a sterile environment, such as an operating room.
[0042] According to a further preferred embodiment, the implant template may have a protective layer, and this protective layer completely covers the information applied to the carrier element, in particular the at least one implant view and optional additional information. A protective layer is particularly useful for protecting markings, such as printed information. The applied information can either be scratch-resistant or protected by such a protective layer to prevent abrasion of the information, such as ink particles from which the information is formed, from entering the patient's body.
[0043] A protective layer can be formed on the implant template in a simple and cost-effective way if it is designed as a transparent or translucent adhesive strip. The adhesive strip can, for example, be adhesive on one side only.
[0044] For ease of handling, it is advantageous if the support element is circular, oval, or polygonal, particularly triangular, quadrilateral, pentagonal, or hexagonal. The shape of the support element can therefore deviate from the outer contour of the two-dimensional implant view; consequently, the support element can project beyond the two-dimensional implant view on one or more sides, allowing the areas of the support element not covered by the two-dimensional implant view to be used as a viewing or retention area.
[0045] To avoid injury to body tissue with the implant template, it is advantageous if the edges of the support element are rounded or have a chamfer.
[0046] To enable the fastest possible implant placement, it is advantageous for the template to display two different implant views. These views can be top-down perspectives of the implant from different angles. This allows the template to be positioned against a body structure from various directions, enabling the determination of its size and / or shape. Only a single template is required for this purpose. Therefore, the user does not need to position two templates sequentially against the body structure, but can instead use a single template in different orientations to measure and position it.In particular, the support element can be deformed in such a way that the two different implant views define different planes, especially planes running perpendicular to each other, for example, perpendicularly.
[0047] Preferably, the two different implant views represent side views of the implant oriented transversely, particularly perpendicularly, to each other. For example, with intervertebral disc implants, intervertebral bodies, femoral components, or the like, significantly different implant views can thus be depicted on a single implant template.
[0048] Implant templates can be provided for a wide variety of applications. It is advantageous if at least one implant depicted on the template is a spinal implant, a bone plate, a bone screw, an intervertebral disc implant, an intervertebral disc implant, a knee joint implant, a tibial plate of a knee joint implant, or a femoral component of a knee joint implant. However, in principle, all other implants not mentioned in this non-exhaustive list, which are intended for use in a patient's body, can also be represented as two-dimensional implant views on a carrier element to create an implant template.
[0049] Preferably, the implant template is designed as a disposable item. This eliminates the need for complex reprocessing, particularly cleaning and sterilization, before reuse. For example, it can be made of a biodegradable carrier material, allowing the implant template to be disposed of in an environmentally friendly manner after a single use.
[0050] Furthermore, the problem stated at the outset is solved according to the invention by an implant template system comprising at least two of the implant templates described above, wherein the at least two implant templates differ. In particular, this can be achieved by different information being applied to the respective implant templates, for example, the two-dimensional view of the implant or other optional information.
[0051] Advantageously, the at least two implant templates differ from each other in the size and / or shape of the depicted implant view. For example, the support element of the implant templates can be the same size and shape. However, the two-dimensional implant views of the at least two implant templates differ in size and / or shape. This allows a user to sequentially apply the at least two implant templates to a patient's body structure and thus determine which size and / or shape best suits the body structure, and then select the appropriate implant to be ultimately implanted. The at least two implant templates can be provided together in sterile packaging.
[0052] Furthermore, it can be advantageous if the at least two implant templates differ in the size of their support elements. In particular, identical two-dimensional implant views can be depicted on support elements of different sizes.
[0053] Furthermore, it can be advantageous if the at least two implant templates of the implant template system are manufactured as a single piece. This allows, in particular, different views of an implant, or even implants of different sizes with identical views, to be depicted on the two implant templates. The single-piece design ensures that the user actually has access to all the necessary implant sizes as corresponding views. For example, the implant templates can be separated only when needed, i.e., in the operating room.
[0054] Preferably, the implant template system is designed to be cut to size and / or includes predetermined breaking lines for separating the at least two implant templates of the one-piece implant template system from each other. This design allows a user, in particular, to easily and reliably disassemble the implant template system into the individual implant templates.
[0055] Furthermore, a method for determining the optimal implant size for implantation in a human or animal patient is proposed. This method utilizes one of the implant template systems described above. An implant template is selected from the system and placed against a patient's bone such that the implant representation on the template corresponds to the orientation of the implant to be implanted. The size of the implant representation on the template is then compared to the patient's physiological situation. A decision is then made as to whether the implant size shown on the template is suitable for the patient. If the determined implant size is suitable, the user can select the appropriate implant and implant it into the patient's body.If the implant size is not suitable, he can select another implant template and perform the comparison again with the body's own structure, such as a bone or the like.
[0056] Preferably, the procedure is repeated until the most suitable implant size is determined. This method allows for the identification of optimally fitting implants without the need for prior preparation. Elaborately designed three-dimensional trial implants, matching the shape and size of the implants to be implanted regardless of the material they are made of (e.g., metal or plastic), are also unnecessary. Instead, the implant templates described above, which are easy and inexpensive to produce, allow for the simple and reliable identification of an optimally fitting implant.
[0057] Furthermore, the use of an implant template system described above for carrying out one of the procedures described above is proposed.
[0058] The foregoing description therefore includes in particular the embodiments of implant templates and implant template systems defined below in the form of numbered sentences: 1. Implant template (32), characterized in that the implant template comprises a support element (34) with a front (36) and a back (38), that the support element (34) is formed from a flat material, that the support element (34) carries or has at least one two-dimensional implant view (40) of an implant (10) and that the support element (34) has at least one see-through area (42, 44, 46, 48) which allows a view through the support element (34). 2. Implant template according to sentence 1, characterized in that the at least one transparent area (42, 44, 46, 48) is formed in the form of an opening (52) or a translucent or transparent carrier element area (54, 56, 58) of the carrier element (34). 3. Implant template according to one of the preceding sentences, characterized in that the implant view defines an inner and / or outer contour (60, 62, 64, 66) and that the at least one sight-through area (42, 44, 46, 48) is arranged or formed adjacent to the inner and / or outer contour (60, 62, 64, 66). 4. Implant template according to one of the preceding sentences, characterized in that the implant view (40) includes at least one implant opening (20, 22, 26) of the implant (10). 5. Implant template according to sentence 4, characterized in that the at least one implant opening (20, 22, 26) forms the at least one transparent area (44, 46, 48). 6. Implant template according to sentence 4 or 5, characterized in that the at least one implant opening (20, 22, 26) comprises a screw hole (22) or a fixation hole (26). 7. Implant template according to one of the preceding sentences, characterized in that the support element (34) is designed in the shape of a plate or disc. 8. Implant template according to one of the preceding sentences, characterized in that the support element (34) has a thickness (68) which is defined by a distance between the front (36) and the back (38), and that the thickness (68) has a value of at most 3 mm, in particular at most 1 mm. 9. Implant template according to sentence 8, characterized in that the thickness (68) is at least 0.05 mm, in particular at least 0.5 mm. 10. Implant template according to one of the preceding sentences, characterized in that the implant template (32) is made of one or more biocompatible materials. 11. Implant template according to one of the preceding sentences, characterized in that the support element (34) is made of a biocompatible support element material. 12. Implant template according to one of the preceding sentences, characterized in that the carrier element (34) is made of a plastic, in particular of polymethyl methacrylate (PMMA), glycol-modified polyethylene terephthalate (PETG) and / or polypropylene (PP). 13. Implant template according to one of the preceding sentences, characterized in that the support element (34) is made of a transparent and / or translucent support element material. 14. Implant template according to one of the preceding sentences, characterized in that the implant view (40) is a top view of one side of the implant (10). 15. Implant template according to one of the preceding sentences, characterized in that the implant view (40) is printed or engraved on the carrier element (34) or formed by laser marking or by a thin metallic stamping part, in particular on the front (36). 16. Implant template according to one of the preceding sentences, characterized in that the back (38) of the carrier element (34) is translucently mattified. 17. Implant template according to one of the preceding sentences, characterized in that the support element (34) is designed to be flexibly deformable. 18. Implant template according to one of the preceding sentences, characterized in that the support element (34) is curved according to the implant (10) shown. 19. Implant template according to one of the preceding sentences, characterized in that the support element (34) is designed to be plastically deformable. 20. Implant template according to one of the preceding sentences, characterized in that the implant template (32) comprises at least one retaining element (88) for holding the implant template (32), in particular with a retaining instrument. 21. Implant template according to sentence 20, characterized in that the at least one retention element (88) is designed in the form of a support element area (86) without a two-dimensional implant view (40). 22. Implant template according to sentence 20 or 21, characterized in that the at least one retaining element (88) is designed to protrude from the support element (34). 23. Implant template according to one of sentences 20 to 22, characterized in that the at least one retaining element (88) is formed integrally with the support element (34), in particular from the flat material. 24. Implant template according to one of sentences 20 to 23, characterized in that the at least one retaining element (88) is designed in the form of a tab (90) projecting from the support element (34). 25. Implant template according to one of sentences 20 to 24, characterized in that the at least one retaining element (88) is designed to be deformable, in particular bendable, relative to the support element (34). 26. Implant template according to one of sentences 20 to 25, characterized in that the at least one retaining element (88) and the support element (34) enclose a retaining angle (94) in a handling position and that the retaining angle (94) is in a range from 0° to about 120°, in particular about 90°. 27. Implant template according to one of sentences 20 to 26, characterized in that the support element (34) has at least one bending area which allows deformation of the support element (34), and that the at least one retaining element (88) is arranged or formed outside the bending area. 28. Implant template according to one of the preceding sentences, characterized in that the carrier element (34) carries, has or comprises at least one further implant-specific information. 29. Implant template according to sentence 28, characterized in that the implant-specific information is a size (72), a length and / or an article number (74) of the depicted implant (10). 30. Implant template according to one of the preceding sentences, characterized in that the carrier element (34) carries or comprises at least one measuring scale (70). 31. Implant template according to sentence 30, characterized in that the measuring scale (70) is designed in the form of a millimeter scale. 32. Implant template according to sentence 30 or 31, characterized in that the at least one retaining element (88) is arranged or formed adjacent to or near the measuring scale (70), in particular in an extension thereof. 33. Implant template according to one of the preceding sentences, characterized in that the implant template (32) is designed to be sterilizable, in particular by exposure to a gas or electromagnetic radiation or particle radiation or hot steam. 34. Implant template according to one of the preceding sentences, characterized in that the implant template (32) has a protective layer and that the protective layer completely covers the information applied to the carrier element (34), in particular the at least one implant view (40) and optional further information. 35. Implant template according to sentence 34, characterized in that the protective layer is formed in the form of a transparent or translucent adhesive strip. 36. Implant template according to one of the preceding sentences, characterized in that the support element (34) is circular, oval or polygonal, in particular triangular, quadrilateral, pentagonal or hexagonal. 37. Implant template according to one of the preceding sentences, characterized in that edges (76) of the support element (34) are rounded or have a chamfer. 38. Implant template according to one of the preceding sentences, characterized in that the carrier element (34) has two different implant views. 39. Implant template according to sentence 38, characterized in that the two different implant views (40) represent side views of the implant (10) oriented transversely, in particular perpendicularly, to each other. 40. Implant template according to one of the preceding sentences, characterized in that the at least one implant (10) shown on the implant template is a spinal implant, a bone plate (12), a bone screw (126), an intervertebral disc implant (116), an intervertebral implant, a knee joint implant (96), a tibial plate (100) of a knee joint implant (96) or a femoral component (98) of a knee joint implant (96). 41. Implant template according to one of the preceding sentences, characterized in that the implant template (32) is designed as a disposable article. 42. Implant template system (78) comprising at least two implant templates according to any of the preceding sentences, wherein the at least two implant templates (32) differ. 43. Implant template system according to sentence 42, characterized in that the at least two implant templates (32) differ from each other in the size and / or shape of the depicted implant view (40). 44. Implant template system according to sentence 42 or 43, characterized in that the at least two implant templates (32) differ from each other by the size of the support element (34). 45. Implant template system according to one of sentences 42 to 44, characterized in that the at least two implant templates (32) of the implant template system (78) are formed in one piece. 46. Implant template system according to sentence 45, characterized in that the implant template system (78) is designed to be cuttable and / or includes predetermined breaking lines for separating the at least two implant templates (32) of the one-piece implant template system (78) from each other. 47. Method for determining an optimal implant size for an implant to be implanted in a human or animal patient, characterized in that an implant template system (78) according to one of sentences 42 to 46 is provided, that an implant template (32) is selected from the implant template system (78), that the selected implant template (32) is placed against a bone of the patient such that the implant view (40) of the implant (10) on the implant template (32) corresponds to the orientation of the implant (10) to be implanted, that the size of the implant view (40) shown on the implant template (32) is compared with the physiological situation of the patient, and that a decision is then made as to whether the implant size shown on the implant template (32) is suitable for the patient or not. 48. Method according to sentence 47, characterized in that the method is carried out until the most suitable implant size is determined. 49. Use of an implant template system according to one of sentences 42 to 46 for carrying out a procedure according to sentence 47 or 48.
[0059] The following description of a preferred embodiment of the invention, in conjunction with the drawing, serves for further explanation. The drawing shows: Fig. 1: A schematic perspective, partially cut-out view of an embodiment of an implant in the form of a bone plate, which is attached to a spine with screws; Fig. 2: A schematic perspective view of an exemplary embodiment of an implant template, which provides a two-dimensional view of the in Fig. 1 shows the implant depicted; Fig. 3: a schematic view of the implant template made of Fig. 2 when measuring on the patient's body; Fig. 4: a schematic representation of an exemplary embodiment of an implant template system; Fig. 5: a schematic perspective view of another embodiment of an implant template; Fig. 6: a schematic representation of a part of the in Fig. 4 illustrated embodiment of an implant template system; Fig. 7: a schematic representation of another embodiment of an implant template system; Fig. 8: a schematic representation of another embodiment of an implant template; Fig. 9: a view of the implant template from Fig. 8 in the direction of arrow A when bending it; Fig. 10: a view of the implant template from Fig. 8 in the direction of arrow B when bending it; Fig. 11: a schematic representation of another embodiment of an implant template system; Fig. 12: a schematic representation of another embodiment of an implant template; Fig. 13: a view in the direction of arrow C of the implant template Fig. 12 with bent retaining element; Fig. 14: a view of the similar Fig. 13, however with a deformed support element; Fig. 15: a view of the implant template from Fig. 12 in the direction of arrow B in Fig. 12 after bending them; Fig. 16: a side view of an exemplary embodiment of a knee joint endoprosthesis; Fig. 17: A top view of a tibial component of the in Fig. 16 knee joint endoprostheses shown; Fig. 18: a schematic representation of another embodiment of an implant template system; Fig. 19: a perspective view of a femoral component of a knee joint endoprosthesis; Fig. 20: another embodiment of an implant template with two two-dimensional implant views; Fig. 21: a perspective view of an exemplary embodiment of a meniscus component of a knee joint endoprosthesis; Fig. 22: a schematic representation of a further embodiment of an implant template comprising two two-dimensional implant views; Fig. 23: a schematic perspective view of an exemplary embodiment of an intervertebral disc implant; Fig. 24: a schematic representation of another embodiment of an implant template system; Fig. 25: a schematic representation of a further embodiment of an implant template system; and Fig. 26: a purely schematic representation of an exemplary embodiment of an implant template system.
[0060] In Fig. Figure 1 schematically shows a first embodiment of an implant 10. It is designed in the form of a bone plate 12, with which two adjacent vertebrae 14 and 16 of a spine 80, which are connected to each other via an intervertebral disc 18, are coupled together.
[0061] The bone plate 12 includes a central opening 20 and four screw holes 22 and defines a longitudinal axis 24. It is also symmetrical to a plane of symmetry containing the longitudinal axis 24.
[0062] The screw holes 22 are elongated and extend parallel to the longitudinal axis 24. The screw holes 22 are located in the region of the four corners of the essentially rectangular bone plate 12. The opening 20 is centrally located in the bone plate 12 and has an essentially hexagonal contour. The outer corners of the bone plate 12 are rounded.
[0063] Lying on the longitudinal axis 24, two fixation holes 26 are formed in the bone plate 12, which are also designed as openings in the bone plate 12. They have a circular cross-section. The two fixation holes 26 are each located in the area between two adjacent screw holes 22.
[0064] The bone plate 12 is anchored in the two vertebrae 14 and 16 with four bone screws 28. Before anchoring with the four bone screws 28, the bone plate 12 is pre-fixed to the two vertebrae 14 and 16 with two bone pins 30 that pass through the fixation holes 26.
[0065] To determine the appropriate size of implant 10, at least one implant template 32 is provided. Fig. 2 and Fig. Figure 3 shows an embodiment of such an implant template 32.
[0066] The implant template 32 comprises a carrier element 34 with a front 36 and a back 38. The carrier element 34 is made of a flat material.
[0067] The support element 34 carries at least one two-dimensional implant view 40 of an implant 10 or has such a two-dimensional implant view 40.
[0068] Furthermore, the support element 34 has at least one transparency area 42, 44, 46, 48 which allows a view through the support element 34.
[0069] The support element 34 is plate- or disc-shaped. The one in the Fig. 2 and Fig. The illustrated embodiment 3 shows a support element 34 which is oval in shape.
[0070] Alternative embodiments of support elements 34, not shown, are circular or polygonal, in particular three, four, five or hexagonal.
[0071] The at least one transparent area 42, 44, 46 or 48 is formed in the form of a perforation 52 or in the form of a translucent or transparent support element area 54, 56, 58.
[0072] The implant view 40 defines an outer contour 60 and at least one inner contour 62, 64, and 66. The view-through area 42 is formed adjacent to the outer contour 60. The view-through area 44 is formed adjacent to the inner contour 64. The view-through area 46 is formed adjacent to the inner contour 66. The view-through area 48 is formed adjacent to the inner contour 62.
[0073] The implant view 40 includes at least one implant perforation 20, 22, 26 of the implant 10. Thus, the exemplary embodiment of the implant template 32 shows four screw holes 22, two fixation holes 26 and a central perforation 20.
[0074] To determine the relationship of the implant openings 20, 22, 26 to the implant 10, which is shown schematically in Fig. Figure 1 shows the implant openings 20, 22, 26 in the exemplary embodiment of the Fig. 2 and Fig. 3 uses the same reference symbols as in Fig. 1 shown implant 10.
[0075] The implant perforations 20, 22, 26, namely the four screw holes 22, the perforation 20 and the two fixation holes 26, each form one of the view areas 44, 46 and 48.
[0076] The support element 34 has a thickness 68, which is defined by the distance between the front 36 and the back 38. The thickness 68 has a value of at most 3 mm. In particular, it is at most 1 mm.
[0077] Furthermore, the thickness is at least 0.05 mm. In preferred embodiments, the thickness is at least 0.5 mm.
[0078] The implant template 32 is made of one or more biocompatible materials. The carrier element 34 is made of a biocompatible carrier element material.
[0079] The support element 34 is also made of a plastic. It is the one described in the Fig. 2 and Fig. The embodiment shown in Figure 3 uses polymethyl methacrylate (PMMA). In alternative embodiments, the plastic is glycol-modified polyethylene terephthalate (PETG) and / or polypropylene (PP).
[0080] The support element 34 is optionally made of a transparent and / or translucent support element material.
[0081] The implant view 40 is designed in the form of a top view of one side of the implant 10. In the exemplary embodiment of the Fig. 2 and Fig. Figure 3 is a top view of the front 36 of the support element 34. Fig. 1. Bone plate shown.
[0082] The implant view 40 is printed onto the carrier element 34. In alternative embodiments, the implant view 40 is engraved, laser-marked, or formed by a thin metallic stamping.
[0083] In alternative embodiments, the implant view 40 is formed or applied to the back 38 of the carrier element 34.
[0084] In exemplary embodiments, the back side 38 of the support element 34 is translucently frosted. In this way, the transparent areas 42, 44, 46, and 48 are also designed to be translucent. If, in certain exemplary embodiments, the frosting is not applied to all areas of an otherwise transparent support element 34, individual transparent areas 42, 44, 46, and 48 can also be made transparent if the support element 34 is not translucently frosted in that area.
[0085] In one embodiment, the support element 34 is designed to be flexibly deformable.
[0086] In another embodiment, the support element 34 is curved according to the illustrated implant 10.
[0087] In one embodiment, the support element 34 is designed to be plastically deformable. This allows the user to bend the support element 34 into a desired shape. Due to its plastic deformability, the support element 34 then retains the deformation specified by the user.
[0088] The exemplary embodiment of the Fig. 2 and Fig. Figure 3 features an optional measuring scale 70. In this embodiment, it is implemented as a millimeter scale. In this embodiment, the measuring scale 70 is enclosed by the Fig. 2 and Fig. 3 in extension of the narrow sides of the implant view 40 along a longitudinal axis 24, which forms an axis of symmetry of the implant template 32. The measuring scale 70 is optionally printed, engraved, laser-marked, or formed by a thin metallic stamping.
[0089] The implant template 32 is designed to be sterilizable. It can be sterilized by exposure to a gas and / or electromagnetic radiation and / or particle radiation and / or hot steam.
[0090] In the exemplary embodiment of the Fig. 2 and Fig. 3 at least one further implant-specific piece of information. The implant-specific information is a dimension 72, which in the case of the exemplary embodiment of the Fig. 2 and Fig. 3 corresponds to a length that is in the Fig. 2 and Fig. 3 is indicated with "28". Further implant-specific information is the article number of the depicted implant 10, indicated in the figures with the designation "SC615T".
[0091] In order to protect the implant-specific information, and in particular the implant view 40, from abrasion, the implant template 32 has a protective layer not shown in the figures, which completely covers the information applied to the carrier element 34, and in particular the at least one implant view 40 and, as described, optional further information.
[0092] In one embodiment, the protective layer is formed as a transparent or translucent adhesive strip. This ensures that the carrier element 34 retains or is at least translucent. A translucent adhesive strip can thus function as a translucent frosting. For example, a transparent carrier element 34 can be coated with a translucent adhesive strip so that, if the protective layer completely covers a front surface 36 or a back surface 38, areas of the implant template not covered by the implant view 40 or implant-specific information remain translucent.
[0093] Edges 76 of the carrier element 34, which may define an outer contour of the carrier element 34 as well as optionally openings thereof, are rounded in a manner not shown in detail or have a chamfer in order to avoid injury to body tissue when using the implant template, in particular when inserting it into the body of the patient.
[0094] The implant template 32 is designed as a single-use item. This means that after a single use on a patient, it is not reprocessed and sterilized, but disposed of directly.
[0095] In Fig. Figure 4 shows an example of an implant template system 78. It comprises at least two implant templates 32. In the upper area of the Fig. 4 is the arrangement of the Fig. 2 and Fig. Figure 3 is shown schematically. The implant template 32, which is brought towards the two vertebral bodies 14, 16, is shown as part of the implant template system 78 with dashed lines.
[0096] The implant template system 78 of the in Fig. The embodiment shown in Figure 4 comprises a total of eight implant templates 32, all of which are designed differently. Thus, at least two implant templates 32 differ from each other. In the embodiment of the implant template system 78, Fig. The implant templates 32 differ from each other in the size of the depicted implant view 40. This is particularly evident from the size of the implant view 40, and also from the different specification of the size 72 and the respective different specification of the article number 74.
[0097] The implant template system 78 thus comprises eight implant scrapings 32, which show eight differently sized implants 10 in the form of bone plates 12. The length of each bone plate 12 varies in 2 mm increments from a minimum length of 20 mm to a maximum length of 34 mm.
[0098] The support elements 34 of the implant templates 32 of the implant template system 78 of the Fig. 4 are oval and all identical in size.
[0099] The implant template system 78 enables a procedure for determining the optimal implant size for an implant 10 to be implanted in a human or animal patient. For this purpose, an implant template system 78 is first provided.
[0100] To determine the size of the implant 10 to be permanently implanted in the patient, one of the implant templates 32 of the implant template system 78 is selected and brought laterally against the body structure in such a way that Fig. Figures 2 to 4 schematically represent the body structure through a section of a spine 80, such that a user sees the implant view 40 of the implant template 32 from the side on which the implant 10 is to be positioned on the body structure. The implant template 32 is brought into contact with the body structure, for example, the patient's spine 80, such that the implant view 40 of the implant 10 on the implant template 32 corresponds to the orientation of the implant to be implanted.
[0101] A user can now compare the size of the implant view 40 shown on the implant template 32 with the patient's physiological situation, i.e., their body structure, and then decide whether the implant size shown on the implant template 32 is suitable for the patient. If it is not suitable, the user sets the selected implant template 32 aside and chooses one of the remaining implant templates 32 from the implant template system 78. The user then repeats this process until the most suitable implant size, in their opinion, is determined. This information can then be obtained directly from the implant template 32, specifically from the indicated size 72 or the indicated article number 74.
[0102] In particular, with bone plates 12, it can be determined in a simple and cost-effective manner, as described, whether bone screws 78 can be reliably anchored in the vertebrae 14 and 16, taking into account the position of the screw holes 22.
[0103] Once the implant template 32 has been determined to match the implant 10 that best fits in size and, if necessary, shape, the position of the fixation holes 26 on vertebrae 14 and 16 can be marked, for example, using a medical instrument 82 in the form of a center punch. The instrument 82 has a tip 84 for this purpose, which can be used to mark vertebrae 14 and 16. The implants can then be inserted at the marked locations in conjunction with the implant. Fig. The bone pins 30 described in section 1 are inserted so that the implant 10 corresponding to the implant view 40 can then be slid over the bone pins 30 and brought into contact with the vertebrae 14 and 16. In a final step, the bone plate 12 can then be attached with, for example, the four in Fig. Fix the bone screws 28 shown in Figure 1 to vertebrae 14 and 16.
[0104] Further exemplary embodiments of implant templates 32 and implant template systems 78 are shown schematically below in conjunction with the Fig. 5 to 26. The properties of the implant templates 32 of these embodiments correspond to those described above in connection with the embodiments in the Fig. 2 to 4 were explained.
[0105] To designate identical or similar components or elements, the following applies in the exemplary embodiment: Fig. 5. The same reference symbols are used as in the embodiment of the Fig. 2 to 4. This also applies accordingly to the further ones in the Fig. Examples of embodiments shown in 6 to 26.
[0106] Fig. Figure 5 shows an embodiment of an implant template 32, which shows a bone plate 12 designed to connect a total of three vertebrae 14 and 16 in order to stiffen two motion segments of a spine 80, which are formed by two intervertebral discs 18 between each pair of adjacent vertebrae 14 and 16.
[0107] Accordingly, the implant view 40 shows two transparent areas 48, each corresponding to a perforation 20 on the implant 10.
[0108] The implant templates 32 of the in the Fig. In the embodiments illustrated in Figures 2 to 5, the support element 34 is designed such that it projects beyond the implant view 40 on all sides along the outer contour 60. Thus, the implant template 32 comprises a support element area 86 without the implant view 40, which surrounds the implant view. The support element area 86 can serve, in particular, for handling the implant templates 32, specifically in the form of a holding element 88. Therefore, the implant template 32 can be grasped by a user with two fingers or a suitable holding instrument, such as a needle holder or forceps, and attached to a body structure of the patient, for example, their spine 80, as shown in the illustrations. Fig. 2 to 5 are presented schematically and introduced.
[0109] Fig. Figure 6 schematically shows an embodiment of an implant template system 78 comprising three implant templates 32. Their support elements 34 are identically shaped. In contrast, the depicted implant views 40 are of different sizes. This is evident both from the size of the implant view 40 and from the respective specified size 72 and article number 74.
[0110] Fig. Figure 7 shows another embodiment of an implant template system 78. In this implant template system 78, the support elements 34 are geometrically similar but of different sizes. Thus, the at least two implant templates 32 differ from each other in the size of the support element 34.
[0111] However, in the implant template system 78, the implant views 40 are also designed differently. They correspond to the three implant views 40 of the three in Fig. 6 shown implant templates 32. Thus, the implant templates 32 of the implant template system 78 also differ from each other in the size of the shown implant views 40.
[0112] Fig. Figure 8 shows an embodiment of an implant template 32 in a top view. Side views of this implant template 32 are shown in the Fig. 9 and Fig. 10 schematically represented. Fig. 9 and Fig. Figure 10 shows by way of example how the support element 34 can be deformed, in particular bent. In particular from a flat initial position, into the Fig. 9 and Fig. As shown in dashed lines 10, the support element 34 can be bent, particularly with respect to semi-axes extending parallel and perpendicular to the longitudinal axis 24 of the depicted implant 10. Deformation can optionally occur such that the support element 34 is curved concavely or convexly towards a body structure.
[0113] Another embodiment of an implant template system 78 is shown schematically in Fig. Figure 11 shows four of the eight implant templates, which together have eight implant views 40 of different sizes, are equipped with a retaining element 88 for holding the implant template 32, in particular with a retaining instrument not shown in the figures, in the form of a retaining element 88 projecting from the carrier element 34. This retaining element 88 is formed integrally with the carrier element 34, namely from the flat material from which the carrier element 34 is formed, for example by cutting or punching.
[0114] The four in Fig. In the implant templates 32 shown in the lower area, the retaining element 88 is formed in the form of a tab 90 projecting from the support element 34 in the direction of a short half-axis of the oval support element 34.
[0115] The tab 90, and thus the retaining element 88, is located along a [path] in an embodiment of an implant template 32 in Fig. The bending line 11, shown with a dashed line, is designed to be deformable, i.e., bendable. This makes it possible to move the holding element 88 and the support element 34 into a handling position in such a way that they enclose a holding angle which lies in a range between 0° and approximately 120°. In particular, the holding angle 94 can be 0°.
[0116] In addition, the support element 34 forms further retention elements through support element areas 86 without implant view 40. Thus, a user has several options to hold the implant template 32 and to bring it into contact with a patient's body structure.
[0117] The Fig. Figures 12 to 14 show a further embodiment of an implant template 32. Fig. Figure 12 schematically shows the implant template 32 in a basic position in which the support element 34 and the laterally projecting retention element 88 lie in one plane. This is, in particular, a plane defined by the flat material from which the support element 34 is formed.
[0118] In Fig. Figure 13 shows a schematic side view of the implant template 32. The tab 90 is bent here around the retention angle 94 along the bending line 92. The retention angle 94 lies in a range between 0° and approximately 120°. Fig. At 13 degrees it is approximately 90°. Fig. Figure 13 schematically shows the support element 34 undeformed.
[0119] In Fig. 14 is the implant template 34 made of Fig. 13 with a support element 34 bent with respect to a small semi-axis of the oval support element 34. Fig. 15 again indicates a deformed support element 34 with respect to a major semi-axis of the oval support element 34.
[0120] Fig. Figure 16 schematically shows another embodiment of an implant 10 in the form of a knee endoprosthesis 96 comprising a femoral component 98 for fixing to a femur of a patient (not shown in the figures), a tibial component 100 for anchoring to a tibia 102 of a patient, and a meniscal component 104 arranged between the tibial component 100 and the femoral component 98.
[0121] Before the implantation of the knee joint endoprosthesis 96, the tibia 102 is prepared and a flat tibial surface 106 is formed by a saw cut.
[0122] Fig. Figure 17 schematically shows a top view of a tibial component 100 anchored to the tibia 102.
[0123] To determine the optimal tibial component 100 for a patient, for example, a measurement is taken in Fig. Figure 18 provides a schematically illustrated embodiment of an implant template system 78. This implant template system 78 comprises three implant templates 32, each showing an implant view 40 of the tibial component 100, specifically a top view. The support elements 34 are each larger than the implant view, so that a transparent area 42 adjacent to the outer contour 60 of the implant view 40 is formed. This area can simultaneously also form a support element area 86, which can be used as a retention element 88. Optional measuring scales 70 are also shown on these implant templates.
[0124] In this embodiment of the implant template system 78, the support elements 34 are of identical size, but the implant views 40 differ in size. This is immediately apparent both visually and through the additional information provided, namely the size 72 and the article number 74 of the implant 10, whose implant view 40 is formed on the support element 34.
[0125] With the implant template system 78, the optimally fitting size of the implant 10, and thus of the tibial component 100, can be determined in the manner described above by comparing the body's own structure with the implant view 40 shown on the implant scraping ions 32.
[0126] Fig. Figure 19 schematically shows a perspective view of an embodiment of a femur component 98.
[0127] To determine the size of the femoral component to be implanted, implant templates 32 can be used, which are exemplified in Fig. Figure 22 shows two different schematic views 40 of the implant 10, which is formed by the femoral component 98, on the support element 34. These are two mutually perpendicular views, one of the femoral component 98 from the front, and one of the femoral component 98 from the rear. Fig. 20 shown on the left on the support element 34, as well as a side view of the femur component 98, in Fig. 20 is shown in the right area of the support element 34.
[0128] With the implant template 32, which is exemplified in Fig. As shown in Figure 20, the size of the femoral component 98 can be determined by bringing the left area of the implant template 32, with the implant view 40, into contact with the knee joint from the front. Additionally, the side view of the femoral component 98 on the implant template 32 can be brought into contact with the knee joint from the side. A retention element 88 is defined by a support element area 86 without an implant view 40. This support element area 86 borders on the outer contours 60 of the implant views 40.
[0129] In this embodiment, optional additional information specific to the implant 10 is also shown, namely in particular a size 72 and an article number 74 of the implant 10, whose implant views 40 are shown on the carrier element 34.
[0130] Fig. Figure 21 schematically shows a meniscus component 104, which forms an implant 10. In Fig. Figure 21 also schematically depicts an implant template 32. The implant template 32 essentially forms an implant template system 78 comprising two implant templates 32 with oval support elements 34, which are connected via a tab-shaped connecting element 108. A distance 110 defined by the connecting element 108 between the two support elements 34 corresponds to a height 112 of the meniscus component 104.
[0131] The connecting lines 114 between the connecting element 108 and the support elements 34 can be used as bending lines, separation lines, or predetermined breaking points. For example, the connecting lines 114 can be used as bending lines, as schematically shown in Fig. Figure 21 shows how to align the two support elements 34 parallel to each other, so that the two support elements 34 are each bent by 90° with respect to the connecting element 108.
[0132] Alternatively, the two support elements 34 can also be separated from the connecting element 108 along the connecting lines 114, so that two separate implant templates 32 are formed, which together form an implant template system 78.
[0133] Therefore, the implant template system 78 is designed as a single piece and comprises two implant templates 32.
[0134] The support elements 34 are each identically designed. In contrast, the implant views 40 differ in their shape. The size is identical, as can be seen from the implant-specific information size 72 and article number 74 on the implant templates 32. One of the implant templates 32 shows the implant 10, i.e., the meniscus component 104, in a top view from below, namely in Fig. 22 on the left, as well as in a top view, in Fig. 22 right.
[0135] In Fig. Figure 23 schematically depicts a spine 80 with an implant 10 in the form of an intervertebral disc implant 116 inserted into the space between two vertebrae 14 and 16. If the intervertebral disc implant 116 is designed with two attachment plates 118 that are movable relative to each other, it can be used as an intervertebral disc implant 116. If the attachment plates 118 are fixed relative to each other, the implant 10 forms an intervertebral implant, for example, to stiffen a motion segment of the spine 80, which is originally formed by an intervertebral disc 18 between vertebrae 14 and 16. If the intervertebral disc 18 is removed, an intervertebral disc implant 116 or an intervertebral implant can be inserted into the cleared disc space between vertebrae 14 and 16.
[0136] Fig. Figure 24 schematically shows another embodiment of an implant template system 18. Three implant templates 32 are shown here as examples. The support elements 34 are circular and each carries an implant view 40 in the form of a side view of the intervertebral disc implant 116. Fig. 23.
[0137] The implant views 40 of the three implant templates 32 differ in size from one another. This is immediately apparent from the implant views 40 themselves as well as from the implant-specific information indicated on the implant templates 32, namely size 72 and article number 74.
[0138] Measuring scales 40 assist the user in determining the optimal size of the implant 10 to be implanted. As previously described, one of the implant templates 32 is selected and positioned laterally against the spine 80 to determine the height of the intervertebral disc space, i.e., the distance between the two vertebrae 14 and 16. This distance ideally corresponds to a height 120 of the intervertebral disc implant, i.e., the distance between a top surface 122 and a bottom surface 124 of the implant 10, as depicted in implant view 40. The implant template system 78 thus allows for the simple determination of the intervertebral disc space height and, consequently, the selection of the appropriate implant 10.
[0139] The implant templates 32 can be handled by hand or with holding instruments, as already explained in other embodiments, by grasping and handling them on a support element area 86 without implant view 40, which thus forms a holding element 88.
[0140] Another embodiment of an implant template system 78 is shown schematically in Fig. Figure 25 illustrates this. It includes, by way of example, three implant templates 32, each comprising support elements 34 of identical size and oval shape. Each support element 34 has an implant view 40 of an implant 10, which is designed in the form of a bone screw shaped like a pedicle screw.
[0141] The implant views 40 differ in their size, which is directly recognizable and indirectly readable from the optional implant-specific information, namely size 72 and article number 74.
[0142] As before, one of the implant templates 32 of the implant template system 78 is selected for application and brought into contact with a body structure of the patient, namely a pedicle of a vertebra, in order to determine a maximum possible length of the bone screw 126 to be inserted by comparison with the implant view 40 shown on the implant template 32.
[0143] In conclusion, it shows Fig. Figure 26 schematically and in a maximally abstract manner illustrates an embodiment of an implant template system 78 with at least two implant templates 32. The support elements 34 of the implant templates 32 carry or have an implant view 40 of an implant 10 to be implanted into the body of a patient. The implant view 40 has a view-through area 42 adjacent to the outer contour 60 of the implant view 40 and a view-through area 44 adjacent to an inner contour 62 of the implant view 40.
[0144] The implant views 40 of the implant templates 32 differ in both size and shape. Furthermore, the support elements 34 also differ in size. Support element areas 86 without implant view 40 form retention elements 88 for handling the implant templates 32 and for positioning them against a body structure of the patient that is to be wholly or partially replaced by the implant 10, whose implant view 40 is shown on the implant templates 32.
[0145] The support elements 34 optionally exhibit the properties described above in connection with the embodiments already described, such as elastic or plastic deformability of the support element 40. Fig. Not shown are further implant-specific information such as size 72 or article number 74 or one or more measuring scales that can be used to determine the size and select the implant 10 to be implanted permanently.
[0146] The implant view 40 can be used in the Fig. The implant template system 78 shown in Figure 26 depicts any implant 10 in a top view from any side. The implant 10 can be a spinal implant, a bone plate, a bone screw, an intervertebral disc implant, an intervertebral implant, a knee joint implant, a tibial plate of a knee joint implant, a femoral component of a knee joint implant, or a meniscal component of a knee joint implant.
[0147] The implant templates 32 of the implant template system 78 can either be designed separately or as a single piece. Optionally, in the latter case, they are designed to be cut to size or include predetermined breaking lines for separating the at least two implant templates 32 from one another.
[0148] Furthermore, retaining elements 88 in the form of tabs 90 can optionally be formed on the support elements 34, as on one of the implant templates 32 in Fig. 26 schematically represented by dashed lines.
[0149] With implant templates 32, as explained above in conjunction with preferred embodiments, the shape and / or size of an implant to be ultimately implanted in a patient can be determined by a surgeon in a simple and cost-effective manner. The implant templates 32, preferably made of a plastic material, allow a direct comparison of the size of the implant view 40 shown on the implant template 32 with a body structure.
[0150] If the support element 34 is wholly or partially translucent in areas without implant visibility 40, a user can directly determine whether the implant template 32 is positioned sufficiently close to the patient's own body structure, for example, a bone structure such as the spine 80. The structure behind the support element 34 becomes more clearly and distinctly visible the closer the implant template 32 is to the body structure. Optimal visibility is achieved when the implant template 32 is in direct contact with the body structure. Thus, a translucent support element 34 can also be used, in particular, to qualitatively determine the distance between the support template 32 and the body structure.
[0151] Unlike known three-dimensional trial implants, which are used to determine implant size before implantation, this method does not require the creation of complex three-dimensional implant structures. Instead, the proposed implant templates 32 exploit the fact that a surgeon typically views the body structure from (only) one direction. An implant template 32, which shows the implant 10 in a top view from precisely this direction—namely, a corresponding implant view 40 on the support element 34—allows for a direct size comparison.
[0152] Such a size comparison is particularly possible even if the body structures have not yet been prepared for the insertion of implant 10. For example, the size of the schematically in Fig. The implant shown in section 23 will be determined before the intervertebral disc 18 is removed between vertebrae 14 and 16.
[0153] The implant templates 32 can be offered individually sterile-packaged. It is also possible to offer implant template systems 78 with two or more implant templates 32 in a single sterile package, so that after opening it in a sterile area, for example an operating room, all implant templates 32 of the implant template system 78 are available. Reference symbol list 10 implants 12 bone plate 14 vertebrae 16 vertebrae 18 Intervertebral disc 20 Breakthrough 22 screw holes 24 Longitudinal axis 26 Fixation holes 28 bone screws 30 bone pins 32 implant templates 34 Support element 36 Front 38 Back 40 Implant view 42 Viewing area 44 Viewing area 46 Viewing area 48 Viewing area 52 Breakthrough 54 Support element area 56 Support element area 58 Support element area 60 Outer contour 62 Inner contour 64 Inner contour 66 Inner contour 68 Thickness 70 measuring scale Size 72 74 Item number 76 edge 78 Implant template system 80 Spine 82 Instrument 84 top 86 Support element area 88 retaining element 90 tab 92 Bending curve 94 mounting brackets 96 Knee joint endoprosthesis 98 Femoral component 100 tibial component 102 Tibia 104 Meniscus component 106 tibial area 108 Connecting element 110 distance 112 Height 114 connecting line 116 Intervertebral disc implant 118 Mounting plate 120 height 122 Top 124 Underside 126 Bone screw
Claims
[1] Implant template (32), characterized by that the implant template comprises a carrier element (34) with a front side (36) and a back side (38), that the carrier element (34) is formed from a flat material, that the carrier element (34) carries or has at least one two-dimensional implant view (40) of an implant (10) and that the carrier element (34) has at least one see-through area (42, 44, 46, 48) which enables a view through the carrier element (34). [2] Implant template according to claim 1, characterized by that the at least one see-through region (42, 44, 46, 48) is designed in the form of an opening (52) or a translucent or transparent carrier element region (54, 56, 58) of the carrier element (34). [3] Implant template according to one of the preceding claims, characterized bythat the implant view defines an inner and / or outer contour (60, 62, 64, 66) and that the at least one see-through region (42, 44, 46, 48) is arranged or formed adjacent to the inner and / or outer contour (60, 62, 64, 66). [4] Implant template according to one of the preceding claims, characterized by that the implant view (40) comprises at least one implant opening (20, 22, 26) of the implant (10), wherein in particular the at least one implant opening (20, 22, 26) a) forms at least one see-through area (44, 46, 48) and / or b) comprises a screw hole (22) or a fixation hole (26). [5] Implant template according to one of the preceding claims, characterized by that the carrier element (34) is plate-shaped or disc-shaped. [6] Implant template according to one of the preceding claims, characterized bythat the carrier element (34) has a thickness (68) which is defined by a distance between the front side (36) and the back side (38), and that the thickness (68) has a value of at most 3 mm, in particular at most 1 mm, wherein in particular the thickness (68) is at least 0.05 mm, in particular at least 0.5 mm. [7] Implant template according to one of the preceding claims, characterized by that the carrier element (34) a) is made of a biocompatible carrier element material and / or b) is made of a plastic, in particular polymethyl methacrylate (PMMA), glycol-modified polyethylene terephthalate (PETG) and / or polypropylene (PP), and / or c) is made of a transparent and / or translucent carrier element material. [8] Implant template according to one of the preceding claims, characterized bythat the implant view (40) represents a plan view of one side of the implant (10). [9] Implant template according to one of the preceding claims, characterized by that the back (38) of the carrier element (34) is translucently matt. [10] Implant template according to one of the preceding claims, characterized by that the carrier element (34) a) is designed to be flexible and / or b) is curved in accordance with the implant (10) shown and / or c) is designed to be plastically deformable. [11] Implant template according to one of the preceding claims, characterized by that the implant template (32) comprises at least one holding element (88) for holding the implant template (32), in particular with a holding instrument, wherein in particular the at least one holding element (88) a) is designed in the form of a carrier element region (86) without a two-dimensional implant view (40) and / or b) is designed to protrude from the carrier element (34) and / or c) is formed integrally with the carrier element (34), in particular from the flat material, and / or d) is designed in the form of a tab (90) projecting from the carrier element (34) and / or e) is designed to be deformable, in particular bendable, relative to the carrier element (34) and / or f) and the carrier element (34) in a handling position enclose a holding angle (94) and that the holding angle (94) lies in a range from 0° to approximately 120°, in particular approximately 90°. [12] Implant template according to one of the preceding claims, characterized bythat the carrier element (34) carries, has or comprises at least one further implant-specific information, wherein in particular the implant-specific information is a size (72), a length and / or an article number (74) of the represented implant (10). [13] Implant template according to one of the preceding claims, characterized by that the carrier element (34) carries or comprises at least one measuring scale (70), wherein in particular a) the measuring scale (70) is designed in the form of a millimetre scale and / or b) the at least one holding element (88) is arranged or formed adjacent to the measuring scale (70) or in the vicinity thereof, in particular in an extension thereof. [14] Implant template according to one of the preceding claims, characterized bythat the implant template (32) has a protective layer and that the protective layer completely covers information applied to the carrier element (34), in particular the at least one implant view (40) and optional further information, wherein in particular the protective layer is designed in the form of a transparent or translucent adhesive strip. [15] Implant template according to one of the preceding claims, characterized by that the carrier element (34) has two different implant views, wherein in particular the two different implant views (40) represent side views of the implant (10) oriented transversely, in particular perpendicularly, to one another. [16] Implant template according to one of the preceding claims, characterized bythat the at least one implant (10) shown on the implant template is a spinal implant, a bone plate (12), a bone screw (126), an intervertebral disc implant (116), an intervertebral implant, a knee joint implant (96), a tibial plate (100) of a knee joint implant (96) or a femoral component (98) of a knee joint implant (96). [17] Implant template system (78) comprising at least two implant templates according to one of the preceding claims, wherein the at least two implant templates (32) differ, in particular a) the at least two implant templates (32) differ from one another in the size and / or shape of the displayed implant view (40) and / or b) the at least two implant templates (32) differ from one another in the size of the carrier element (34) and / or c) the at least two implant templates (32) of the implant template system (78) are formed in one piece, wherein in particular the implant template system (78) is designed to be cuttable and / or comprises predetermined breaking lines for separating the at least two implant templates (32) of the one-piece implant template system (78) from one another.
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