Surgical templates and methods for constructing and / or manufacturing surgical templates

A 3D-printed surgical template with a bone-removal guide and ear canal protection features addresses the precision and safety issues in radical mastoidectomy, ensuring accurate bone removal and reducing ear canal damage.

JP2026137077APending Publication Date: 2026-08-26
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Patent Information

Application Number
JP2026019605
Authority / Receiving Office
JP · JP
Patent Type
Applications
Priority Date
2026-02-03
Filing Date
2026-02-09
Publication Date
2026-08-26

AI Technical Summary

Technical Problem

Existing surgical templates for radical mastoidectomy in the temporal bone region lack precision and safety, particularly in guiding bone removal and protecting the ear canal during surgery.

Method used

A surgical template with a 3D-printed template body featuring an opening with an outer edge matching the bone portion to be removed, guide portions for instruments, mounting features, and a cover portion to protect the ear canal, manufactured from materials like polyamide or titanium, ensuring precise bone removal and ear canal protection.

Benefits of technology

The template provides precise guidance for bone removal, reduces the risk of accidental damage to the ear canal, and enhances surgical safety during radical mastoidectomy.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a surgical template (OS) for use in the temporal bone region, particularly within a framework for performing radical mastoidectomy, comprising a template body (SK) having an outer surface (AS) and an inner surface (IS) on which the template body (SK) should be positioned on the temporal bone. [Solution] The template body (SK) is penetrated by an opening (D) that extends from the outer surface (AS) to the inner surface (IS), and the opening (D) of the template body (SK) is defined by an outer edge (AR) that corresponds to the outer contour of the temporal bone portion to be removed.
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Description

Technical Field

[0001] The present invention relates to a surgical template having a template body with an outer surface and an inner surface on which the template body is to be placed on the temporal bone, for use in the area of the temporal bone, particularly within the framework of performing radical mastoidectomy. The present invention further relates to a method for constructing and / or manufacturing a surgical template for use in the area of the temporal bone.

Background Art

[0002] In chronic diseases of the middle ear region, surgical procedures in the form of radical mastoidectomy may sometimes be necessary. In radical mastoidectomy in the temporal bone (os temporale), the mastoid process (pars mastoidea) is cleaned, and usually, the posterior wall of the ear canal is partially removed to form an open cavity consisting of the epitympanum, mastoid process, and ear canal of the middle ear. This cavity is often also called the mastoid cavity or mastoid antrum. In the case of an obvious cholesteatoma of chronic suppurative otitis media of the middle ear, radical mastoidectomy may be necessary. The purpose of radical mastoidectomy is to completely remove the cholesteatoma matrix. In surgeries performed in the cranial, and thus the temporal bone region, the use of surgical templates to assist the surgeon during the operation is also generally known. [[ID=十三]]

[0003] Chinese Utility Model Publication No. 215079279 describes a surgical template in the form of an opening template. This opening template has a template body, and the template body is adapted to be placed on the temporal bone on the inner surface. On the outer surface facing away from the inner surface, a contact area for the patient's auricle is also formed on the template body so that the opening template can be accurately positioned on the patient's temporal bone during placement. In addition, a viewing window and a needle guide adjacent to the viewing window are also formed on the template body.

Summary of the Invention

[0004] Building upon the prior art described above, the problem addressed by the present invention is to provide a surgical template that can assist surgeons when performing surgery in the temporal bone region, preferably when performing radical mastoidectomy.

[0005] This problem is solved in terms of apparatus, based on the combination of the preamble of further independent claim 1 and its characteristic features. In addition, this problem is solved in terms of method by the features of further independent claim 17. Each subsequent dependent claim describes a preferred development of the present invention. Further preferred embodiments can be gathered from the specification and drawings.

[0006] According to a further independent claim 1, a surgical template provided for use in the region of the temporal bone has a template body having an outer surface and an inner surface on which the template body is to be placed on the temporal bone. Preferably, the surgical template is provided for use within the framework of radical mastoidectomy, for example, to treat cholesteatoma, in which the mastoid cavity or mastoid cavity is surgically formed.

[0007] The surgical template according to the present invention has a template body configured to be placed on the temporal bone (os temporale). When the surgical template is used, the template body should be placed on the temporal bone with its inner surface, which should be done before surgery performed on the temporal bone, that is, in particular before radical mastoidectomy.

[0008] In the context of the present invention, the template body is preferably formed within the framework of an additive manufacturing process, and the additive manufacturing process is preferably carried out by a 3D printing process.

[0009] Preferably, the template body is made of a plastic, which is preferably a polymer, more preferably a thermoplastic such as polyamide (PA) or polyether ether ketone (PEEK). Alternatively, the template body may be made of a metallic material, such as titanium or stainless steel, or a metallic alloy, preferably a titanium alloy. The template body may also be made of different materials to obtain locally different properties, such as locally different rigidity. The template body may be formed of one part or multiple parts.

[0010] According to further independent claim 1, the present invention includes the technical teaching that the template body is penetrated by an opening extending from the outer surface to the inner surface. The opening in the template body is defined by an outer edge corresponding to the outer contour of the bone portion of the temporal bone to be removed. In other words, the template body comprises an opening that extends from the outer surface of the template body to the inner surface of the template body and penetrates the template body completely. This opening is formed in the template body to have an outer edge, which is identical to the outer contour of the bone portion of the temporal bone to be removed.

[0011] A surgical template constructed in this manner has the advantage of clearly indicating to the surgeon through the opening which bone portion within the temporal bone region should be removed. In addition, the outer edge of the opening forms a guide, which the surgeon can use to move surgical instruments, especially the bone saw, along. As a result, precise removal of the bone portion is possible. Therefore, overall, surgeries performed in the temporal bone region can be made safer. Thus, in particular, radical mastoidectomy can be performed with confidence.

[0012] The opening of the surgical template preferably has a closed outer edge, in which the opening is completely enclosed in an island-like manner by the material of the template body. Preferably, the opening forms a sawing template in which the outer contour of the bone portion to be removed by sawing is defined by the outer edge of the opening. In use, the opening particularly defines the outer contour of the mastoid process (pars mastoidea) and / or tympanic portion (pars tympanica) of the temporal bone to be removed.

[0013] According to one possible embodiment of the present invention, the outer edge is at least partially formed by the inner contour of the guide portion. By providing a guide portion whose inner contour defines the outer edge of the opening, it is made easier to guide surgical instruments along it during bone removal. Preferably, the guide portion is designed to protrude outward from the rest of the template body to ensure better guidance.

[0014] According to a further possible embodiment of the present invention, the surgical template comprises a mounting portion having through-openings formed therein extending from the outer surface to the inner surface. These through-openings are used to guide the surgical template through one mounting means in any case for mounting it to the temporal bone, which is preferably mounting to the mastoid process of the temporal bone. This has the advantage that this mounting ensures that the surgical template does not slip while surgery is being performed. In particular, bone screws can be guided through the formed through-openings.

[0015] When the two modified forms described above are combined, the mounting portion surrounds the guide portion at least partially, and the guide portion of the template body protrudes outward relative to the mounting portion. As a result, periphery of the surgical template to the bone portion to be removed can be achieved. In particular, the distance over which the mounting portion extends outward is smaller compared to that of the guide portion.

[0016] Alternatively, the guide section can transition seamlessly into the mounting section, so that it does not form a raised guide for the saw blade. As a result, surgical templates can be designed to be more compact. Due to the thinness of the temporal bone wall, a raised guide for the saw blade is often not required.

[0017] According to embodiments of the present invention, the template body has a cover portion that forms a partition. The partition separates the outer and inner surfaces from each other in the area of ​​the cover portion and is provided for covering at least a large portion of the ear canal by the surgical template. Thus, the surgical template can effectively prevent accidental damage to the ear canal during surgery. This is because, when the surgical template is in a predetermined position, the ear canal, particularly the middle ear canal, is covered by the cover portion of the surgical template, thereby preventing slippage into the ear canal or other accidental damage to the ear canal caused by surgical instruments. More preferably, the cover portion is designed to cover the entire ear canal. In particular, the cover portion is configured in the shape of a cap, i.e., the cover portion preferably has a shape suitable for a protective cap. Preferably, the partition also forms part of the outer edge of the opening at its edge so that the cover portion of the template body is consequently adjacent to the opening. As a result, the cover portion effectively prevents accidental damage to the ear canal by the partition while working in the opening with surgical instruments to remove bone portions.

[0018] In the advanced form of the above-described embodiment, the cover portion curves inward and is used for insertion into the ear canal. The cover portion forms not only a septum but also side walls that project outward relative to the septum. Preferably, the surgical template can be inserted into the ear canal together with the cover portion, thereby achieving particularly reliable protection of the ear canal. In addition, the side walls also provide lateral protection. In particular, the curved cover portion curves in a scoop shape. An inner wall defined by the cover portion can be provided and / or configured so as to be at least partially positioned relative to the inner wall of the ear canal. Preferably, the side walls at least partially surround the periphery of the septum of the cover portion.

[0019] Furthermore, the cover portion of the template body is provided at the end of the template body that slopes inward. In this case, the template body is partially sloped inward, i.e., at the end. The cover portion defines a portion of the outer edge of the opening by the edge of the septum. Preferably, the cover portion forms a surface on the septum facing the outer surface, which is used to position surgical instruments used to remove the bone portion of the temporal bone and to define the excision depth. Thus, this has the advantage that the cover portion of the surgical template also forms a reference for the depth of bone to be removed. Thus, the surgeon performing the surgery can position instruments on the cover portion and begin the excision of the bone portion from the cover portion. The end is inclined in particular with respect to the attachment portion provided for attaching the surgical template to the temporal bone.

[0020] When the aforementioned modified form is combined with a possible embodiment of the present invention, the outer edge of the opening is at least partially formed by the inner contour of the guide portion, and this formation of the outer edge of the opening is particularly preferably carried out away from the inclined end. As a result, the surgeon can work laterally toward the bone to be removed, starting from the surface of the cover portion, within the framework of the surgery.

[0021] According to a further possible embodiment of the present invention, at least one drill guide portion is further formed in the template body, and the at least one drill guide portion forms at least one drill hole extending from the outer surface to the inner surface, and in any case is used to guide a bone drill for removing a bone portion of the temporal bone. As a result, the surgical template can also assist the surgeon in removing a bone portion of the temporal bone by drilling, thereby ensuring the removal of a portion of the temporal bone that extends particularly in the depth direction. The bone portion to be removed using the bone drill is preferably a portion of the tympanic portion (pars tympanica) of the temporal bone.

[0022] In an advanced form of the above-described embodiment, at least one drill guide section may have one guide region at each end located at least on the outer surface, in which the inner diameter of the drill hole approximates the outer diameter of the bone drill. As a result, proper guidance of the bone drill in the surgical template for the surgeon is achieved. More preferably, each guide region is formed by a guide sleeve introduced into the template body in at least one guide section. The latter is achieved particularly when the template body is made of polymer and the introduced guide sleeve is formed from a metallic material. Thus, preferably, higher strength can be achieved in the region of each drill guide section.

[0023] In addition to or instead of the above-described configuration, a stop surface is formed on the outer surface of at least one drill guide portion coplanar with the opening of the drill hole, and this stop surface forms a stop for a surgical instrument that guides the bone drill. The length of each drill hole corresponds to the drill depth to be achieved on the inner surface by the bone drill when the surgical instrument reaches each stop surface. This has the advantage that a clear drill depth can be defined by the formed stop, and as a result, over-drilling can be reliably prevented.

[0024] More preferably, multiple drill guide sections are formed in the surgical template. As a result, the surgical template defines multiple bone portions to be removed using a bone drill.

[0025] When an embodiment of the guide portion is combined with an embodiment of at least one drill guide portion, the at least one drill guide portion is formed in a guide portion adjacent to the inner contour. As a result, the bone portion to be removed is defined by an opening surrounded by the guide portion, and any further bone portions to be removed adjacent to this bone portion to be removed are defined by at least one drill guide portion.

[0026] According to a possible embodiment of the present invention, the template body is designed in a patient-specific manner. Thus, preferably, the surgical template is specially adjusted to the patient. In particular, at least the path of the outer edge of the opening, the size of the opening, the position of the opening in the template body, and optionally the position of at least one drill guide part in the surgical template are adapted to the patient. Alternatively, the template body can be shaped in a non-patient-specific manner. In this case, the template body has a predetermined standard shape corresponding to a typical human anatomical structure. The template body can be provided in various sizes for this purpose.

[0027] In a development of the above possible embodiment, a template body having a contact contour on the inner surface can be designed, and this contact contour is configured as at least approximately a corresponding part of the surface contour of the temporal bone in the placement area. As a result, the template body can be properly placed on the temporal bone.

[0028] In particular, the area where the surgical template is to be placed on the temporal bone has been pre-captured for the patient-specific design of the surgical template, for example, by CT, within the framework of a medical imaging process.

[0029] According to a further independent claim 13, the present invention also relates to a method for constructing and / or manufacturing a surgical template for use in the area of the temporal bone. The template body is configured to have an outer surface and an inner surface on which the template body is to be placed on the temporal bone. An opening extending from the outer surface to the inner surface is provided in the template body, and an outer edge corresponding to the outer contour of the bone part of the temporal bone to be removed is defined in the opening.

[0030] Thus, within the context of the method according to the invention, the configuration or manufacture or both the configuration and manufacture of the surgical template are carried out. "Configuration" is to be understood as meaning, in particular, the planning and design of the surgical template, i.e., creating a design or template for manufacturing the surgical template. "Manufacture" is intended to mean the manufacture of the surgical template, i.e., the physical embodiment of the surgical template. In particular, both the configuration and manufacture of the surgical template are carried out within the framework of the method according to the invention. The manufacture is preferably carried out within the framework of an additive manufacturing process, more preferably within the framework of a 3D printing process.

[0031] Thus, preferably, the configuration and / or manufacture of the surgical template can be carried out, and the use of the surgical template clearly and accurately shows the surgeon which bone parts within the region of the temporal bone should be removed. In addition, a guide can be formed by the outer edge of the opening, along which the surgeon performing the operation can move a surgical instrument, particularly a bone saw. As a result, accurate removal of the bone part is possible. Thus, generally, the operation performed in the region of the temporal bone can be made safer. Thus, preferably, the surgeon can be assisted when performing a radical mastoidectomy.

[0032] Preferably, the surgical template is also formed taking into account the configuration and / or creation according to at least one of the above-described deformation forms of the surgical template.

[0033] According to a further possible embodiment of the method according to the invention, the planning and / or manufacture of a temporal bone implant is also carried out together with the surgical template. Preferably, this temporal bone implant can then be used to cover the void within the temporal bone formed by removing the bone part after a radical mastoidectomy has been performed.

[0034] Preferred embodiments of the invention described below are shown in the drawings.

Brief Description of the Drawings

[0035] [Figure 1] A perspective view of a surgical template according to one embodiment is shown. [Figure 2] A perspective view of a portion of the skull within the temporal bone region, showing the marked area of ​​the temporal bone to be removed. [Figure 3] Figure 1 shows a further perspective view of the cranial region after the surgical template has been placed. [Figure 4] Figure 1 shows a further perspective view of the cranial region after the surgical template has been placed. [Figure 5] Figure 1 shows a further perspective view of the cranial region after the surgical template has been placed. [Figure 6] Figure 1 shows a further perspective view of the cranial region after the surgical template has been placed. [Figure 7] A further perspective view of the cranial region after removal of the temporal bone region is shown. [Figure 8] Further diagrams of the skull after the insertion of the temporal bone implant are shown. [Figure 9] A diagram of a surgical template according to a further possible embodiment of the present invention is shown. [Figure 10] Another figure of a surgical template according to a further possible embodiment of the present invention is shown. [Figure 11] Further figures of surgical templates according to further possible embodiments of the present invention are shown. [Figure 12] Figures 9 to 11 show the cranial region after the surgical template has been placed. [Figure 13] Figures 9 to 11 show the cranial region after the surgical template has been placed. [Modes for carrying out the invention]

[0036] Figure 1 shows a perspective view of a surgical template OS designed according to an embodiment of the present invention. The surgical template OS has a template body SK, which is configured to be positioned on the temporal bone on its inner surface IS. The template body SK is penetrated by an opening D, where the opening D of the template body SK extends from the inner surface IS to the outer surface AS located opposite the inner surface IS.

[0037] The opening D has an outer margin AR, which in the surgical template OS is defined by the medial contour IK of the guide portion FA of the template body SK. The opening D is designed in the form of an island on the template body SK, in such a way that the guide portion FA completely surrounds the opening D and the outer margin AR is closed by the medial contour IK.

[0038] On the outside, the guide portion FA is partially surrounded by a mounting portion BA, which has multiple through-openings DO, each extending from the inner surface IS to the outer surface AS. The guide portion FA protrudes from the mounting portion BA towards the outer surface AS of the template body SK.

[0039] In addition, the guide section FA has multiple drill guide sections BFA adjacent to the passage D, and each of the multiple drill guide sections BFA forms a drill hole BK that extends continuously from the outer surface AS to the inner surface IS. The drill guide sections BFA are designed so that the range between the inner surface IS and the outer surface AS is partially different, thereby obtaining drill holes BK of different lengths.

[0040] The template body SK of the surgical template OS is manufactured from a polymer within the framework of an additive manufacturing process, preferably within the framework of a 3D printing process. The polymers used are thermoplastics such as polyethylene (PE) or polyether ether ketone (PEEK). Guide sleeves FH are introduced into the template body SK at the opening of the drill guide section BFA on the outer surface, and these guide sleeves FH are made of metallic materials such as titanium.

[0041] The guide sleeve FH forms a guide region FB on each associated drill guide section BFA, where the inner diameter of the drill hole BK is reduced over the length of the guide sleeve FH. In addition, a stop surface ASF is defined on the outer surface AS by the guide sleeve FH in all cases, and this stop surface is coplanar with the opening of the drill hole BK.

[0042] In addition, the template body SK has a contact contour AK on its inner surface IS, which is only partially visible in Figure 1.

[0043] The configuration and fabrication of the surgical template OS shown in Figure 1 are carried out for actual patient-specific use in the temporal bone SB region of skull S. For this purpose, the shape of the skull S was predetermined by a medical imaging process, particularly CT, taking into account a 3D model of skull S, partially shown in Figures 2 to 8. The surgical template OS is formed in a patient-specific manner by configuring the opening D and drill guide portion BFA of the surgical template OS according to the bony portions KA1 and KA2, indicated by shading in Figure 2, which are declared to be the region of the temporal bone SB of skull S to be removed within the framework of radical mastoidectomy. Radical mastoidectomy should be performed in such a way that the cholesteatoma can be completely removed, particularly in the area of ​​the external auditory canal GG. The contact contour AK of the template body SK is configured, at least approximately, as the corresponding portion of the surface contour of the temporal bone SB in the region surrounding bony portions KA1 and KA2.

[0044] In this case, the bone portion KA1 to be removed is part of the mastoid process (pars mastoidea) of the temporal bone SB, while the bone portion KA2 to be removed is part of the tympanic portion (pars tympanica) of the temporal bone SB and forms part of the posterior bone wall W of the external auditory canal GG.

[0045] Figures 3 to 6 show the surgical template OS positioned on the temporal bone SB, and the positioning of the template body SK on the temporal bone SB with a contact contour AK formed on the inner surface IS is particularly evident in Figure 4. The surgical template OS is attached to the temporal bone SB by the attachment portion BA, and for this purpose, bone screws in particular are guided through the through-opening DO to screw the surgical template OS to the temporal bone SB.

[0046] Through the passage D of the surgical template OS, the surgeon is shown the areas of bone KA1 and KA2 to be removed by the osteosaw, and the surgeon can move along the medial contour IK of the guide FA while working with the osteosaw.

[0047] Further areas of bone portions KA1 and KA2 to be removed are also defined in the surgical template OS by drill holes BK in the drill guide section BFA, each drill hole BK used to guide the bone drill KB through to remove the bone portion. The bone drill KB is shown in Figures 5 and 6. In Figure 6, the guide sleeve FH introduced into the template body SK on the outer surface AS is also visible, and the inner diameter defined by the guide area FB of the guide sleeve FH approximates the outer diameter of the bone drill KB. As a result, guidance of the bone drill KB in the drill guide section BFA is achieved.

[0048] The different drilling depths of the bone drill KB are defined on the inner surface (IS) by the stop surface (ASF) and the drill holes (BK) of different lengths. This is evident in Figure 6. To achieve each drilling depth, the surgeon must guide the bone drill KB and the surgical instrument to contact the respective stop surface (ASF).

[0049] Furthermore, Figure 7 shows the skull after the removal of bony portions KA1 and KA2, and the removal of bony portions KA1 and KA2 creates a space FS in the temporal bone SB. Due to the fact that bony portion KA1 forms part of the mastoid process and bony portion KA2 forms part of the tympanic region, the space FS has a space portion FS1 in the mastoid region and a space portion FS2 in the tympanic region, with the latter removing part of the wall W. To cover this space FS, a temporal bone implant SI is attached to the temporal bone SB, as shown in Figure 8. This temporal bone implant SI is constructed in a patient-specific manner with a surgical template OS based on the determined skull shape S.

[0050] Furthermore, Figures 9 to 11 show various diagrams of the surgical template OS' according to another possible embodiment of the present invention. This surgical template OS' is similar to the modified form shown in Figure 1 and is also provided for use in the temporal bone region, particularly for performing radical mastoidectomy.

[0051] The surgical template OS' is similarly constructed in a patient-specific manner and has a template body SK' made of metal, particularly titanium or a titanium alloy, in contrast to the deformed form shown in Figure 1. Alternatively, the surgical template OS' can be made of plastic. The template body SK' is constructed to be positioned on the temporal bone on the inner surface IS and has an opening D' that penetrates the template body SK' from the inner surface IS to the outer surface AS located on the opposite side, as is particularly evident in Figure 9. Furthermore, the template body SK' has a contact contour AK' partially on the inner surface IS, which, within the framework of the patient-specific configuration of the surgical template OS', is constructed at least approximately as a corresponding portion of the relevant temporal bone surface contour within the placement area.

[0052] In the template body SK', the opening D' is designed in an island shape and, for this purpose, is completely surrounded by an outer edge AR' that is partially defined by the inner contour IK' of the guide portion FA' and partially defined by the edge K of the cover portion AA. In the region of the guide portion FA', the template body SK' also surrounds the guide portion FA' and includes a mounting portion BA' with a through-opening DO. Similar to the modified form shown in Figure 1, these through-openings DO are provided to guide through bone screws, by which the surgical template OS' can be attached to the temporal bone in the intended position. The through-openings DO extend between the inner surface IS and the outer surface AS. In addition, the guide portion FA' protrudes toward the outer surface AS side relative to the mounting portion BA'.

[0053] As is particularly clear from Figure 10, the cover portion AA is formed on one end E of the template body SK', and this end E causes the template body SK' to be inclined toward the inner surface IS with respect to the mounting portion BA'. The cover portion AA is curved in a scoop shape toward the inner surface IS, and this curvature forms the partition wall TW and the side wall SW. The partition wall TW provides a local separation between the inner surface IS and the outer surface AS adjacent to the opening D'. The side wall SW surrounds the partition wall TW and protrudes toward the outer surface AS of the template body SK' relative to the partition wall TW.

[0054] Figures 12 and 13 show the surgical template OS', specially configured for this purpose, positioned on the temporal bone SB' of the skull S', as shown in Figures 9-11. As is particularly clear in Figure 12, the ear canal GG' is completely covered by the septum TW of the cover AA, and the surgical template OS' is also inserted into the ear canal GG' together with the cover AA. This is particularly clear when referring to Figure 13, which also shows that the cover AA is in partial contact with the inner wall IW of the ear canal GG' in the attached state of the surgical template OS'.

[0055] The bone portion to be removed is identified in the temporal bone SB' by the opening D' of the attached surgical template OS'. Damage to the ear canal GG' is also effectively prevented by the cover AA, with the septum TW preventing slippage into the ear canal and the lateral wall SW protecting the inner wall IW of the retained ear canal GG'.

[0056] Furthermore, the septum TW forms surface A, on which the surgeon performing the operation can position surgical instruments, and surface A defines the depth of resection. Therefore, the surgeon can, for example, use a bone cutter and work laterally toward the bone to be removed, starting from surface A. For this purpose, the template body SK' of the surgical template OS' does not have a guide portion FA' in the region of the inclined end E, otherwise the surgeon can move the surgical instrument along this guide portion.

[0057] Embodiments of the present invention can provide a surgical template that can assist surgeons when performing surgery in the temporal bone region, preferably radical mastoidectomy. [Explanation of Symbols]

[0058] OS, OS'... Surgical template, SK, SK'... Template body, IS... Inner surface, D, D'... Opening, AS... Outer surface, AR, AR'... Outer edge, IK, IK'... Inner contour, FA, FA'... Guide part, BA, BA'... Mounting part, DO... Through opening, BFA... Drill guide part, BK... Drill hole, FH... Guide sleeve, FB... Guide area, ASF... Stopping surface, AK, AK'... Contact contour, SB, SB'... Temporal bone, S, S'... Skull, KA1, KA2... Bone part, GG, GG'... Ear canal, W... Wall, KB... Bone drill, FS... Gap, FS1, FS2... Gap portion, SI... Temporal bone implant, K... Edge, AA... Cover part, E... End, TW... Septum, SW... Lateral wall, IW... Inner wall, A... Surface.

Claims

1. A surgical template (OS, OS') for use in the region of the temporal bone (SB, SB'), particularly within a framework for performing radical mastoidectomy, comprising a template body (SK, SK'), wherein the template body (SK, SK') has an outer surface (AS) and an inner surface (IS) on which the template body (SK, SK') is to be positioned on the temporal bone, characterized in that the template body (SK, SK') is penetrated by an opening (D, D') extending from the outer surface (AS) to the inner surface (IS), and the opening (D, D') is defined by an outer edge (AR, AR') corresponding to the outer contour of the bony portion of the temporal bone (SB, SB') to be removed.

2. The surgical template (OS, OS') according to claim 1, characterized in that the outer edges (AR, AR') are at least partially formed by the inner contours (IK, IK') of the guide portions (FA, FA') of the surgical template (OS, OS').

3. The surgical template (OS, OS') according to claim 1 or 2, wherein the template body (SK, SK') comprises an attachment portion (BA, BA') having a through-opening (DO) extending from the outer surface (AS) to the inner surface (IS), and the through-opening (DO) is designed to guide the surgical template (OS, OS') to the temporal bone, preferably to the mastoid process of the temporal bone (SB, SB'), in either case through a single attachment means.

4. The surgical template (OS, OS') according to claims 2 and 3, characterized in that the mounting portion (BA, BA') at least partially surrounds the periphery of the guide portion (FA, FA'), and the guide portion (FA, FA') protrudes toward the outer surface (AS) relative to the mounting portion (BA, BA'), or the mounting portion (BA) transitions seamlessly toward the guide portion (FA).

5. The surgical template (OS') according to at least one of claims 1 to 4, characterized in that the template body (SK') has a cover portion (AA) that forms a partition (TW), the partition (TW) separates the outer surface (AS) and the inner surface (IS) in the area of ​​the cover portion (AA), and is provided for covering at least a large portion of the ear canal (GG') by the surgical template (OS').

6. The surgical template (OS') according to claim 5, characterized in that the cover portion (AA) curves toward the inner surface (IS) and is used for insertion into the ear canal (GG'), and the cover portion (AA) forms not only the septum (TW) but also a side wall (SW) that protrudes toward the outer surface (AS) relative to the septum (TW).

7. The surgical template (OS') according to claim 5 or 6, characterized in that the cover portion (AA) of the template body (SK') is provided on the end (E) of the template body (SK') that is inclined toward the inner surface (IS), the cover portion (AA) defines a part of the outer edge (AR') of the opening (D') by the edge portion (K) of the partition wall (TW), and the cover portion (AA) is preferably used to position a surgical instrument used to remove the bony portion of the temporal bone (SB') and forms a surface (A) that defines the depth of resection.

8. The surgical template (OS') according to claims 2 and 7, characterized in that the outer edge (AR') of the opening (D') is formed away from the inclined end (E) by the inner contour (IK') of the guide portion (FA').

9. A surgical template (OS) according to at least one of claims 1 to 8, characterized in that at least one drill guide portion (BFA) is further formed on the template body (SK), and the at least one drill guide portion (BFA) forms at least one drill hole (BK) extending from the outer surface (AS) to the inner surface (IS), and in any case is used to guide a bone drill (KB) for removing the bone portion of the temporal bone (SB).

10. The surgical template (OS) according to claim 9, characterized in that the at least one drill guide portion (BFA) is provided with one guide region (FB) at each end located at least on the outer surface (AS), and in the guide region (FB), the inner diameter of the drill hole (BK) approximates the outer diameter of the bone drill (KB).

11. The surgical template (OS) according to claim 10, characterized in that each of the guide regions (FB) is formed by a guide sleeve (FH), and the guide sleeve (FH) is introduced into the template body (SK) in at least one guide portion (BFA).

12. A surgical template (OS) according to at least one of claims 9 to 11, characterized in that a stop surface (ASF) is formed on the outer surface of the at least one drill guide portion (BFA) on the same plane as the opening of the drill hole (BK), the stop surface (ASF) forms a stop for a surgical instrument that guides the bone drill (KB), and the length of each of the drill holes (BK) corresponds to the drill depth to be achieved by the bone drill (KB) on the inner surface (IS) when the surgical instrument reaches each of the stop surfaces (ASF).

13. A surgical template (OS) according to at least one of claims 9 to 12, characterized in that multiple drill guide portions (BFAs) are formed thereon.

14. The surgical template (OS) according to claim 2 and at least one of claims 9 to 13, characterized in that the at least one drill guide portion (BFA) is formed on the guide portion (FA) adjacent to the inner contour (IK).

15. The surgical template (OS, OS') according to at least one of claims 1 to 14, characterized in that the template body (SK, SK') is designed in a patient-specific manner.

16. The surgical template (OS, OS') according to claim 15, characterized in that the template body (SK, SK') has a contact contour (AK, AK') on its inner surface (IS), and the contact contour (AK, AK') is configured, at least approximately, as a corresponding portion of the surface contour of the temporal bone (SB, SB') within the placement area.

17. A method for constructing and / or manufacturing a surgical template (OS, OS') for use in the region of the temporal bone (SB, SB'), wherein the template body (SK, SK') is configured to have an outer surface (AS) and an inner surface (IS) on which the template body (SK, SK') is to be placed on the temporal bone, and an opening (D, D') extending from the outer surface (AS) to the inner surface (IS) is provided in the template body (SK, SK'), and an outer edge (AR, AR') is defined in the opening (D, D'), the outer edge (AR, AR') corresponding to the outer contour of the bony portion of the temporal bone (SB, SB') to be removed.

18. The method according to claim 17, characterized in that the template body (SK, SK') is further configured according to any one of claims 2 to 16.

19. The method according to claim 17 or 18, characterized in that the temporal bone implant (SI) is further planned and / or manufactured together with the surgical template (OS, OS').