Surgical guide system for computer-assisted surgery (CAS)

The surgical guide system addresses the limitations of radiation-based imaging in fracture surgeries by using a guide device with radiopaque geometry and image processing for precise, radiation-free implant guidance, improving surgical accuracy and reducing procedural time and costs.

JP7739471B2Active Publication Date: 2025-09-16STRYKER EUROPEAN OPERATIONS LIMITED
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Patent Information

Application Number
JP2023575662
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2021-06-08
Publication Date
2025-09-16
Estimated Expiration
2041-06-08

AI Technical Summary

Technical Problem

Current surgical procedures for traumatized bones, such as fractures, rely heavily on radiation-based imaging methods like X-ray and CT, which increase surgical duration, anesthetic effects, and patient radiation exposure, while lacking precision and accuracy in implant positioning.

Method used

A surgical guide system incorporating a guide device with a radiopaque geometric shape and an image processing device for virtual visualization and augmentation, allowing precise implant or tool guidance without extensive imaging, using radiological and optical tracking methods.

Benefits of technology

Reduces surgical time and radiation exposure by providing accurate, real-time guidance for implant placement and tool trajectory, enhancing surgical precision and reducing anesthetic duration and costs.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to surgical guide devices, surgical references, and surgical tracking systems, and in particular to surgical guide devices, surgical references, and surgical tracking systems that enable improved localization of surgical components.
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Description

[Technical Field]

[0001] The present invention relates to surgical guide devices, surgical reference bodies, and surgical tracking systems, and in particular to surgical guide devices, surgical reference bodies, and surgical tracking systems that enable improved localization of surgical components, as well as corresponding methods, computer program products, and storage media having computer program products stored thereon.

[0002] Advances in surgical procedures have been made in recent years. Significant improvements have been achieved with support systems for supporting clinicians, particularly surgeons, during surgery. Fractures, in particular, benefit from surgeon support systems that provide surgeons with instruments that allow them to improve the accuracy of repositioning bone segments and positioning implants, such as screws, nails, and bone plates, as well as the precision of tools, targeting devices, and guide devices.

[0003] Because traumatized bones, i.e., fractures, have limited visual accessibility, monitoring is usually based on radiation principles, such as X-ray imaging, or computed tomography (CT) imaging, or magnetic resonance imaging (MRT) imaging. All these principles and methods have at least one drawback: they use a lot of radiation, require large equipment, and take a considerable amount of time. Each monitoring step during surgery extends the duration of the surgery, thus extending the duration of the effects of the anesthetic, increasing costs and radiation effects.

[0004] Therefore, there is a need for surgical guide devices, surgical references, and surgical tracking systems and corresponding methods that reduce imaging efforts, thereby shortening surgical time and reducing radiation effects on the patient, while at the same time maintaining or improving the level of surgical accuracy. Summary of the Invention

[0005] The present invention provides a surgical guide device, a surgical reference and a surgical tracking system that allow for improved localization and positioning of surgical components, as well as corresponding methods, computer program products and storage media storing computer program products according to the subject matter of the independent claims. Further embodiments are incorporated in the dependent claims.

[0006] According to one embodiment of the present invention, a surgical guide system for computer-assisted surgery (CAS) is provided. The surgical guide system includes a surgical guide device and an image processing device, the surgical guide device including a guide body having a longitudinal extension from a proximal end of the surgical guide device to a distal end of the surgical guide device, the guide body being adapted to guide at least one of a longitudinal surgical implant and a longitudinal tool, the guide body having a guide track extending along the guide body and continuing in a distal direction along a path of movement of at least one of the surgical implant and the surgical tool being inserted and guided; and a radiopaque (radio-dense) geometric shape disposed at a predetermined spatial position and orientation relative to the guide body, the radiopaque geometric shape adapted to provide a unique radiographic projection for any orientation from the proximal end to the distal end of the guide body in an intended orientation of use of the surgical guide device; and the image processing device including visualization means adapted to virtually visualize the orientation of the guide body relative to the patient's anatomy based on the unique radiographic projection of the radiopaque geometric shape; and augmentation means adapted to augment the guide track on the virtual visualization of the orientation of the guide body to visualize a path of movement of at least one of the surgical implant or the surgical tool.

[0007] Thus, surgical instruments, whether in the form of a guide device or other tool, can be monitored by radiological monitoring. Visualizing the orientation of the guide body relative to the patient's anatomy allows the surgeon to get an impression of how the guide body of the guide device is oriented and positioned relative to the patient's anatomy. Augmenting the guide trajectory can further give an impression of the path that the guided item, e.g., a tool or implant, may take during surgery. Visualization of the guide device or guide body can be achieved based on a virtual model of the guide device or on real-time images during surgery. Augmentation is based on additional virtual data, such as the guide trajectory, or additional virtual items, such as scale, surgical corridor, tolerances, etc. Furthermore, various items, even if they are different implant sizes or tool sizes, can be virtually augmented, allowing the surgeon to have additional information at hand during surgery.

[0008] According to one embodiment, the augmenting means is further adapted to augment a reproducible scale along the augmented guide trajectory.

[0009] This allows the surgeon to obtain additional orientation when guiding an item, which may be a tool or implant, along the guide trajectory, and gives an impression not only of the orientation but also of the range of movement of the guided item.

[0010] According to one embodiment, the augmenting means is further adapted to augment a geometry associated with the implant to be implanted relative to the patient's anatomy based on a unique radiographic projection of the radiopaque geometry.

[0011] In this way, the surgeon can obtain visual information about the item to be guided, in particular the implant. Without inserting the real item, the surgeon can check whether the item meets the requirements, for example whether the implant fits the anatomical structure. After checking and possibly modifying the virtual and augmented implants, the surgeon can insert the real implant. Augmentation can also assist the surgeon in this stage of the operation in virtually perceiving the situation, especially if visual access is not available. Augmentation can also be performed via augmented reality glasses worn by the surgeon.

[0012] According to one embodiment, the augmentation means may include a scrolling means that the surgeon may use to selectively scroll through various different items, such as different tools, implant sizes, implant types, etc., until the surgeon identifies the best matching implant.

[0013] Thus, for example, by scrolling through implants with different drill diameters, different implant sizes, different implant types or varieties, especially sub-implants, the appropriate toll can be easily found. For example, if a bone nail is to be augmented, various types of nails can be augmented, including fixation screw types, so that if the augmented fixation screw collides with an anatomical structure that is not suitable for receiving a fixation screw, the surgeon can not only recognize the primary implant, but also determine whether the primary implant is appropriate. By scrolling through the varieties, the surgeon can select the appropriate implant, such as a nail, or a sub-implant, such as a fixation screw, within seconds.

[0014] According to one embodiment, the guide body comprises a hollow shaft having a guide channel, which follows the guide track.

[0015] This provides a reliable guide path for any longitudinal tool or implant. Because the guide trajectory corresponds to the guide channel, the surgeon can rely on the augmented guide trajectory when inserting a tool or implant through the guide channel.

[0016] According to one embodiment, the guide body has a straight track.

[0017] In this way, directed access to the intended location is possible.

[0018] According to one embodiment, the radiopaque geometry includes a first radiopaque sub-geometry and a second radiopaque sub-geometry, the first radiopaque sub-geometry being provided at a proximal end of the surgical guide device and the second radiopaque sub-geometry being provided at a distal end of the surgical guide device, wherein the radiographic projections of the first sub-geometry and the second sub-geometry toward the longitudinal extension of the line provide radiographic projections that are distinguishable from other radiographic projections toward directions different from the longitudinal direction of the line.

[0019] This allows for precise alignment in a given direction, with the smallest deviations being easily noticeable.

[0020] According to one embodiment, the first radiopaque sub-geometry and the second radiopaque sub-geometry, respectively projected towards the longitudinal extension of the straight line, have complementary patterns.

[0021] In this way, deviations from a straight longitudinal line can be easily detected, and even slight deviations from a complementary arrangement are clearly noticeable.

[0022] According to one embodiment, the guide body has a curved track.

[0023] In this way, it is also possible to provide a guide tool for accessing anatomical structures that are inaccessible via a linear trajectory.

[0024] According to one embodiment, the guide body has a curved track along a circle cross section.

[0025] In this way, reduced friction guidance of circularly curved items such as wires or circularly curved nails is possible.

[0026] According to one embodiment, the radiopaque geometry includes a third radiopaque sub-geometry that includes a plurality of fiducial markers distributed within the third radiopaque sub-geometry such that the third radiopaque sub-geometry has a unique projection in each projection direction.

[0027] Thus, the orientation of the guide device may also be determined from a viewpoint that deviates from a predetermined target viewing direction for the first and second radiopaque sub-geometry, for example, a line of sight direction along the guide trajectory.

[0028] According to one embodiment, the surgical guide system further includes: an optical imaging device representing the position and orientation of one of a surgical guide device and a surgical reference body attachable to a patient's anatomy, the optical imaging device having a predetermined line of sight; a light pattern representing the position and orientation of the other of the surgical guide device and the surgical reference body, the light pattern having at least one unique optical sub-pattern, thereby allowing the relative position and orientation of the surgical reference body to be determined with respect to the position and orientation of the surgical guide device; and an image processing device, the image processing device further including: pattern recognition means configured to recognize the position and orientation of at least the sub-pattern of the light pattern with respect to the position and line of sight of the imaging device based on images acquired from the optical imaging device and a stored representation of the light pattern; and visualization means adapted to virtually visualize the surgical guide device represented by one of the optical imaging device and the light pattern, respectively, and to virtually visualize the surgical reference body and the patient's anatomy represented by the other of the light pattern and the optical imaging device, respectively.

[0029] In this way, the relative positions of the optical imaging device and the light pattern can be determined. If the light pattern is known in terms of its structure and size, its image can determine where the image was taken. It is not necessary to take an image of the entire pattern, as long as the imaged portion of the pattern is unique within the entire pattern. Both the optical imaging device and the light pattern represent either a surgical instrument or a surgical reference. Note that the optical imaging device and the light pattern may also represent other items whose relative positions to one another need to be determined. The entire surgical tracking system can support multiple optical imaging devices and can also support multiple light patterns. The light pattern may be printed on a surgical instrument or a reference. When printed, embedded, or affixed to an item, the pattern enables optical referencing, thereby making the item a reference. When an optical imaging device is embedded or affixed to an item, the pattern enables optical referencing, thereby making the item a reference. Optically determining relative position and orientation requires that the relative position and relative imaging or line of sight direction of the optical imaging device with respect to the item, as represented by the optical imaging device, be known. Similarly, the light pattern itself needs to be known, as well as its relative position and orientation with respect to the items represented by the light pattern. If the relative positions and orientations of the optical imaging device and the light pattern with respect to each other can be determined, and the relative positions and orientations of the optical imaging device and the light pattern with respect to the respective items represented by the optical imaging device and the light pattern are known, then the relative positions and orientations of the items with respect to each other can be determined and the positions and orientations of the items with respect to each other can be visualized, which allows for visualization of surgical instruments and reference bodies attached to the patient's anatomy.

[0030] According to one embodiment, the image processing device further includes an augmentation means configured to augment a predetermined movement trajectory of the surgical guide device onto the virtual visualization of the surgical guide device based on the recognized position and orientation of at least a sub-pattern of the light pattern relative to the position and line of sight of the imaging device to visualize the movement path of the surgical guide device relative to the surgical reference body and the patient's anatomical structure represented by the light pattern, respectively.

[0031] In this way, not only can the items represented by the optical imaging device and the light pattern be visualized, but additional information can also be augmented. The surgical instrument's motion path can be the trajectory that an implant or tool can move along when guided by the surgical instrument, and the path can be inside the surgical instrument, outside or within an extension of the surgical instrument, or the range and radius of motion of a tool connected to the surgical instrument, or the contour of an implant to be implanted that can be guided by the surgical instrument. Augmentation can also include augmentation of different items, different sizes of implants applied by the surgical instrument. The augmentation of varieties can be done simultaneously or alternately by scrolling through the different varieties.

[0032] According to one embodiment, the surgical guide device includes a light pattern to create a reproducible relationship between the geometry of the surgical guide device and the position and orientation of the light pattern.

[0033] Thus, when the guide device is used with a reference body attached to an optical imaging device, it can be monitored simultaneously by radiological imaging and optical imaging.

[0034] According to one embodiment, the surgical guide device includes an optical imaging device to create a repeatable relationship between the geometry of the surgical guide device and the position and orientation of the optical imaging device.

[0035] Thus, when the guide device is used with a reference attached to the light pattern, it can be monitored simultaneously by radiological imaging and optical imaging.

[0036] According to one embodiment, the light pattern consists of geometrically uniform light and dark field rasters, in particular square light and dark field rasters, in particular light and black field rasters.

[0037] This makes it easier to reproduce the orientation and position of the pattern. Furthermore, the printing process is easier to implement and the patterns are easier to calculate. Fields of different colors or shades within the square raster form unique pattern areas. Geometrically uniform means that the dimensions of the fields are geometrically uniform, but each field can have a different color or shade to form a unique pattern area.

[0038] According to one embodiment, the light pattern consists of a raster of geometrically uniform fields of different colors, in particular a raster of square colored fields, in particular a raster of color gradient fields.

[0039] Thus, not only can light and dark fields be used, but also different colors. This allows for color coding, which helps the surgeon select the appropriate light pattern. Furthermore, using three or more colors, i.e., light and dark, instead of two options allows more information to be stored on the same surface area. With two options, for example, two fields of light and dark, four different combinations can be reflected. With four options, for example, two fields of yellow, blue, red, and green, four times as many can be reflected, for example, 16 different combinations.

[0040] According to one embodiment, the light pattern consists of a honeycomb raster of light and dark fields, in particular a raster of light and dark circles or light and dark hexagons within the honeycomb raster, in particular a raster of light and black circles or light and dark hexagons.

[0041] This provides a more compact pattern because each field in a honeycomb raster is closer to a circle than a square raster, resulting in a more densely packed pattern than a square pattern. Fields of different colors or shades within a honeycomb raster form unique pattern regions.

[0042] According to one embodiment, the light pattern is composed of honeycomb rasters of different color fields, in particular colored circle or hexagonal rasters within the honeycomb raster, in particular color gradient circle or hexagonal rasters.

[0043] Thus, not only can light and dark fields be used, but also different colors. This allows for color coding that helps the surgeon select the appropriate light pattern. Furthermore, using three or more colors, i.e., light and dark, instead of two options allows more information to be stored on the same surface area. With two options, for example, two fields of light and dark, four different combinations can be reflected. With four options, for example, two fields of yellow, blue, red, and green, four times as many can be reflected, for example, 16 different combinations.

[0044] According to one embodiment, the surgical guide system further includes a surgical reference attachable to the patient's anatomy, the surgical reference having attached thereto the other of the optical imaging device and the light pattern.

[0045] Thus, when the reference object is used in conjunction with a guide device attached to the other of the light pattern and the optical imaging device, the reference object can be monitored simultaneously by radiological imaging and optical imaging.

[0046] According to one embodiment, the surgical reference body includes a radiopaque geometry fixedly and spatially reproducibly connected to the surgical reference body; and a reference body portion having a surface anatomically adapted to the patient's anatomy; wherein the radiopaque geometry has a unique radiographic projection for each proximal-to-distal orientation of the surgical reference body, thereby enabling determination of the spatial position and orientation of the surgical reference body based on two-dimensional radiographic projections of at least a portion of the surgical reference body.

[0047] Thus, it is possible not only to determine relative position and orientation based on light pattern recognition and identification, but also to simultaneously monitor the surgical references, whether in the form of integrally formed or attachable references, by radiological monitoring, thus providing both identification options and allowing them to be used simultaneously.

[0048] According to one embodiment, the surgical reference body includes: a radiopaque geometry having a first radiopaque sub-geometry and a second radiopaque sub-geometry, each sub-geometry being fixedly and spatially reproducibly connected to the surgical reference body; a first reference body portion having a surface anatomically adapted to the patient's anatomy; and a second reference body portion having a surface anatomically adapted to the patient's anatomy; and the first radiopaque sub-geometry and the second radiopaque sub-geometry are fixedly and spatially reproducibly connected to the surgical reference body. Each of the opaque sub-geometry shapes has a unique radiographic projection for each orientation from the base to the tip of the surgical reference body, whereby the spatial position and orientation of the surgical reference body can be determined based on two-dimensional radiographic projections of at least a portion of the surgical reference body using only the first radiopaque sub-geometry shape and the second radiopaque sub-geometry shape, with the first radiopaque sub-geometry shape assigned to the first reference body portion and the second radiopaque sub-geometry shape assigned to the second reference body portion.

[0049] This reduces the focus on the relevant part of the reference body, especially when using larger reference bodies. The leg structure not only allows coverage of a large surface of the patient's anatomy, but also allows access between the legs. Such a reference body can be used in surgeries in the pelvic region, which require reliable reference with a reference body that covers a large area of ​​the pelvis. Depending on the viewing direction during radiological imaging, only a portion of the entire reference body may be visible in the radiological image. Therefore, it is important to be able to determine the position and orientation even when only a partial view is available. When multiple radiopaque sub-geometries are provided, each of which allows for spatial position and orientation determination, it is highly likely that at least one of the radiopaque sub-geometries is within the imaged area, making it possible to determine the position and orientation of the reference body.

[0050] According to one embodiment, the surgical reference body includes: a radiopaque geometry having a first radiopaque sub-geometry, a second radiopaque sub-geometry, and a third radiopaque sub-geometry, each sub-geometry being fixedly and spatially repeatably connected to the surgical reference body; a first leg having an anatomically adapted surface relative to the patient's anatomy; and a second leg having an anatomically adapted surface relative to the patient's anatomy; wherein the first leg having a first end is connected to a first end of the second leg at a leg interface, and the first radiopaque sub-geometry, the second radiopaque sub-geometry, and the third radiopaque sub-geometry are fixedly and spatially repeatably connected to the surgical reference body. Each radiopaque sub-geometry has a unique radiographic projection for each orientation of the surgical reference body from the base end to the tip end, whereby the spatial position and orientation of the surgical reference body can be determined based on two-dimensional radiographic projections of at least a portion of the surgical reference body using only the first radiopaque sub-geometry, the second radiopaque sub-geometry, and the third radiopaque sub-geometry, respectively, wherein the first radiopaque sub-geometry is assigned to the second end of the first leg, the second radiopaque sub-geometry is assigned to the second end of the second leg, and the third radiopaque sub-geometry is assigned to the junction of the first leg and the second leg.

[0051] According to one embodiment, the surgical reference includes at least one apex pin hole.

[0052] In this way, the surgical reference can be fixed to the patient's anatomy, thereby establishing and maintaining the spatial position and orientation between the reference and the patient's anatomy. It is noted that multiple apical holes may be provided. It is noted that in addition to one or more apical pin holes, one or more interfaces may be provided for coupling an optical imaging device or light pattern. Such interfaces are typically provided on the surface side opposite the surface side used for adhering to the patient's anatomy.

[0053] According to one embodiment, at least one apical pin hole is located between the first end and the second end of at least one of the first leg and the second leg.

[0054] Thus, when these radiopaque sub-geometry features are located at the ends of the legs and at the junctions of the legs, the apical pin holes can be provided at a certain distance from the radiopaque sub-geometry features. It should be noted that instead of using the apical pin holes, the reference body can also be fixed to the patient's anatomy via, for example, a loop for Velcro attachment, a connecting element for a pin, or an additional surgical tool (e.g., a railed surgical tool for clamping the Hoffman system).

[0055] According to one embodiment, at least one of the first leg and the second leg includes a first sub-leg and a second sub-leg, a first end of the first sub-leg corresponding to a first end of at least one of the first leg and the second leg, and a second end of the first sub-leg corresponding to a first end of the second sub-leg at the sub-leg junction.

[0056] Thus, the first and second sub-legs allow placement such that the trajectory of the legs follows the patient's anatomy.

[0057] According to one embodiment, the sub-leg interface includes at least one of the at least one apical pin hole.

[0058] Thus, an apical hole can be provided at the junction of the first and second sub-legs, which can correspond to an exposed bone of the patient, the bone being close to the skin, thereby allowing the apical pin hole to be attached to a bone of the patient's anatomy.

[0059] According to one embodiment, the angle between the first leg and the second leg at their junction is less than 90°, in particular less than 60°.

[0060] In this way, a compact leg frame structure can be provided. The leg tracks may be curved, and the curve may be shaped to open up an angle.

[0061] According to one embodiment, the angle between the first and second sub-legs at their junction is less than 90°, in particular less than 60°.

[0062] In this way, a compact leg frame structure can be provided. The leg tracks may be curved, and the curve may be shaped to open up an angle.

[0063] According to one embodiment, one of the first and second legs and the first and second sub-legs of the other of the first and second legs form a W-shape.

[0064] In this way, the entire reference body can be adapted to the patient's anatomy, particularly the pelvic region of the patient's anatomy. The W-shape allows for a stable framework for the legs and sub-legs, provides sufficient open space between the legs at the relevant parts of the patient's anatomy, and can adequately adapt to the patient's pelvic anatomy, particularly where the patient's bones are exposed due to being close to the skin surface, thereby allowing for reliable fixation and positional and orientation referencing between the reference body and the patient's anatomy.

[0065] According to one embodiment, at least a portion of the anatomically compatible surface comprises adhesive means.

[0066] In this way, the reference device can be easily adhered to the patient's anatomy without causing additional damage, although the adhering may be in addition to application to the apical pin.

[0067] According to one embodiment, the adhesive means comprises a portion that is a surface portion coated with an adhesive that is non-irritating to human skin.

[0068] In this way, the reference body can be easily fixed to the patient's anatomy. The adhesive can be activated or deactivated by applying a specific temperature or radiation.

[0069] According to one embodiment, the adhesive means comprises a portion that is part of a touch fastener, the counterpart of which is capable of adhering to human skin.

[0070] In this way, the reference body can be easily fixed to the patient's anatomy and the position of the reference body can be easily corrected if it becomes dislocated.

[0071] According to one embodiment of the present invention, a method is provided for performing the image processing, visualization, and augmentation processes as described above.

[0072] According to one embodiment of the present invention, there is provided a computer program product which, when executed, performs the method described above.

[0073] According to one embodiment of the present invention, there is provided a data storage medium having stored thereon executable code for the computer program product described above.

[0074] It should be noted that the above-described embodiments may be combined, and in combination provide synergistic technical effects and benefits that are greater than the sum of the individual technical effects and benefits. [Brief explanation of the drawings]

[0075] The present invention will be explained with reference to the following drawings. [Figure 1] FIG. 1 is a side view of an exemplary embodiment of a surgical guide device / surgical instrument / tool. [Figure 2] FIG. 1 is a perspective view of an exemplary embodiment of a surgical guide device / surgical instrument / tool, looking from the proximal end toward the distal end. [Figure 3] FIG. 1 is a perspective view of an exemplary embodiment of a surgical guide device / surgical instrument / tool ​​viewed from the proximal to the distal end in a radiographic image. [Figure 4]FIG. 1 is a radiographic side view of a surgical guide device / surgical instrument / tool ​​applied to a patient's anatomy. [Figure 5] FIG. 10 illustrates the complementary matching of first and second radiopaque sub-geometry shapes. [Figure 6] 1A-1C illustrate an exemplary embodiment of a surgical guide device / surgical instrument / tool ​​attached to an optical imaging device. [Figure 7] 1A-1C illustrate an exemplary embodiment of a surgical reference having a square light pattern. [Figure 8] 1A-1C show an exemplary embodiment of a surgical reference having a hexagonal light pattern applied to a patient's anatomy, along with a surgical guide device / surgical instrument / tool ​​attached to an optical imaging device. [Figure 9] 1 is a schematic diagram of an exemplary embodiment of an image processing device; [Figure 10] 1A and 1B show an exemplary embodiment in which an optical imaging device is connected to a surgical tool via a respective interface and a pattern is connected to a reference body connected via a respective interface. [Figure 11] 10A-10C show an exemplary embodiment in which the optical imaging device is connected to a reference body via a respective interface and the pattern is connected to a surgical tool connected via a respective interface. [Figure 12] 10A-10C show an exemplary embodiment of a W-shaped surgical reference body containing unique radiographic projections of different radiopaque sub-geometries. [Figure 13] 10A-10C show an exemplary embodiment of a W-shaped surgical reference with a pointed pin applied in the pointed pin hole. [Figure 14] FIG. 1 illustrates an exemplary embodiment of a method with required and optional method steps. [Figure 15]

[0023] Figures 1A and 1B are diagrams illustrating different application samples of embodiments of the present invention. Note that the same or similar reference numerals indicate the same or similar components. The exemplary embodiments of the present invention will be described below along these figures. DETAILED DESCRIPTION OF THE INVENTION

[0076] In the case of surgical implants and surgical tools, the distal end is defined as the end that is first inserted into the patient's body, and the proximal end is defined as the opposite end. In the case of drilling tools, the end containing the drilling shape is considered to be the distal end, and the shaft for securing the drilling tool to the drilling drive is considered to be the proximal end.

[0077] A (radial) projection can be thought of as an image of a geometric shape projected onto a two-dimensional array.

[0078] Complementary patterns of first and second radiopaque sub-geometric shapes are considered to be matching patterns and together form a closed common pattern. Such matching patterns may be formed, for example, by concentric circles, polygons, or other shapes with uniform circumferential distance or overlap, or by interleaving segments with uniform distance or overlap, such as segments of circles or polygons or other shapes.

[0079] The centerline of a tool, implant, or part thereof is an imaginary line that follows a path having equal distances to the lateral edges of the respective tool, implant, or part thereof.

[0080] The junction of the two legs is considered to be the point where both centerlines of the two legs intersect each other or the point where the distance is smallest.

[0081] The angle between two legs is considered to be the angle subtended by a line tangent to the centerline of each leg extending through the junction of both centerlines.

[0082] The junction of the two legs is the area where both legs towards the junction are no longer separated, i.e. they share an edge.

[0083] Complementary patterns of first and second radiopaque sub-geometric shapes are considered to be matching patterns and together form a closed common pattern. Such matching patterns may be formed, for example, by concentric circles, polygons, or other shapes having uniform circumferential distance or overlap, or by interleaving segments having uniform distance or overlap, such as segments of circles or polygons or other shapes.

[0084] The virtual visualization of the surgical guide device or surgical instrument may include a complete visualization of the surgical guide device and surgical instrument, respectively, but may additionally or alternatively include visualization of the axis of the surgical guide device and surgical instrument, respectively, and / or a characteristic geometric shape, which may be a representative scale and / or outline thereof. The virtual visualization of the surgical guide device or surgical instrument may also include visualization of various available implants, etc., particularly visualization of three different available bone screws in combination with the patient's anatomy to which the screws are intended to be applied, thereby allowing the surgeon to recognize and identify the appropriate screw from among the various screws through the virtual visualization. Note that this is not limited to the number three, and is not limited to screws, but may also include nails, particularly nails with various radii of curvature, and other implants and surgical instruments, such as K-wires.

[0085] The inherent projection of any intended use orientation of a surgical guide device or surgical instrument does not preclude two or more different orientations from being identical, so long as the system and / or surgeon recognizes that each additional orientation with the second and identical projection is outside the intended or reasonable use range. In this regard, repeated pattern projections may be acceptable if it is always ensured that an orientation within the intended or reasonable use range can be determined based on the inherent projection. A surgical guide device or surgical instrument may be considered outside the intended or reasonable use range if it is upside down or oriented in a certain way, but this is not likely to cause significant injury during surgery.

[0086] The correspondence between the reference body and the patient's anatomy can be established by providing multiple (two or more) images from different positions / orientations (e.g., ML, AP, or other different directions) with the reference body attached to the patient's anatomy. Based on these multiple views, the relationship between the reference body and the patient's anatomy is realized through image augmentation. The known geometry of the reference body can determine the scaling of the reference body and the instrument / tool / anatomical structure in the image plane. Different imaging views can be referenced to each other. Furthermore, automatic or manual 2D image segmentation can be performed to establish various reference bodies in relation to the patient's anatomy. This can be supported by a database containing commonly known bone geometries or individually known bone geometries, such as those obtained by postoperative CT.

[0087] 1 and 2 illustrate a surgical guide system 1 for computer-assisted surgical CAS. The surgical guide system 1 includes a surgical guide device 10, shown here as an awl. The surgical guide device 10 includes a guide body 15 having a longitudinal extension from a proximal end 11 of the surgical guide device to a distal end 12 of the surgical guide device 10. The guide body has a hollow shaft 15a and is adapted to guide at least one of a longitudinal surgical implant and a longitudinal tool. The surgical implant may be, for example, a screw, a nail, or a wire. The tool may be a K-wire, a drill, a needle, or the like. The hollow shaft 15a includes a guide channel 15b that extends along the guide body and follows a guide trajectory 16 that continues distally along a path of travel 46 of the surgical implant or surgical tool being inserted and guided. The guide trajectory may be straight, bent, or curved. A straight trajectory can be used to insert straight implants or tolls, such as drills or screws. A curved trajectory can be used to insert bent or curved implants or tools, such as bent nails or bent wires. A guide trajectory should be understood as a trajectory within or on the guide body 15 or hollow shaft. A travel path 46 should be understood as a path extending distally through the guide trajectory 16, i.e., toward the patient. The travel path typically has a curvature similar to that of the guide trajectory 16. If the guide trajectory 16 is straight, the travel path 46 is also straight. If the guide trajectory is curved, the travel path along which a curved implant or tool travels is typically also curved. The travel path defines the path that the guided implant or tool travels during insertion after exiting the distal hollow shaft 15a, here shown as the tool tip 18. The awl shown here has a handle or knob 17, which is used to handle the awl, particularly for applying a blade to the distal end 12 of the awl. The blade leaves an opening through which a tool or implant can be guided through the hollow shaft and distal opening toward the patient.

[0088] 1 and 2 show an awl, it should be understood that the guide device 10 may also be a targeting device for positioning a nail or screw.

[0089] FIG. 2 shows the radiopaque geometry 20 on the knob 17. The radiopaque geometry 20 is positioned at a predetermined spatial location and orientation relative to the guide body 15. The radiopaque geometry 20 provides a unique radiographic projection 25 for any proximal-to-distal orientation of the guide body in the intended orientation of surgical guide device 10. Because the unique projection determines the orientation of the guide device 10, and thus the guide body 15 and hollow shaft 15a, the unique projection can be used to determine the guide track 16 and the path of travel 46 that a tool or implant will follow when guided by the hollow shaft 15a. Note that the hollow shaft may also have a lateral slit (not shown here) for lateral insertion of an implant or tool. This slit may be closed by a cover to form a closed hollow shaft 15a. The guide body 15 includes a hollow shaft 15a with a guide channel 15b that follows the guide track 16.

[0090] The radiopaque geometry 20 may have a first radiopaque sub-geometry 21 and a second radiopaque sub-geometry 22. In this illustration, the first and second radiopaque sub-geometry 21, 22 are located on the knob 17, but may be located anywhere on the guide device 10. Any of the radiopaque geometries 20 or sub-geometry 21, 22, 23 may also be provided as removably attached geometries, for example, with a clip connection. The sub-geometry 21, 22 may be formed together into a clip. By matching key / keyhole elements of the guide device and the radiopaque geometry 20 or radiopaque sub-geometry 21 / 22 / 23, a predetermined orientation and position of the radiopaque geometry 20 / sub-geometry 21, 22, 23 relative to the guide device can be established. The key / keyhole elements may also be used to allow only the radiopaque geometry 20 / sub-geometry 21, 22, 23 intended for use with the guide device 10 to be clipped onto the guide device. The radiopaque geometry may have a unique three-dimensional shape and / or may be composed of sub-geometry shapes that together form a unique projection.

[0091] As shown in FIG. 2, the first radiopaque sub-geometry 21 and the second radiopaque sub-geometry 22 can be realized by two circular rings of radiopaque material arranged concentrically, but in parallel planes rather than in the same plane. When viewed straight from the proximal to distal end, both rings in the projection appear as concentric circles. In this viewing direction, both rings, one first radiopaque sub-geometry 21 and one second radiopaque sub-geometry 22, can form a complementary pattern—two concentric rings that can fit together. When a slightly tilted view is applied from a slightly lateral position, the rings appear as ellipses and are no longer concentric. The concentric shift measurements, the elliptical deformation measurements, and the relative sizes of both rings can provide a basis for calculating not only the lateral viewing angle but also the viewing distance. Because the geometry of the guide device is known, its guide trajectory 16 is also known, and thus, the travel path 46 is also known. This applies not only to straight guide tracks but also to curved guide tracks 16. As shown in Figure 5, the radiographic projection 26 of the first radiopaque sub-geometry 21 and the radiographic projection 27 of the second radiopaque sub-geometry 22 can both have a complementary pattern 29 in a given viewing direction (which can be towards a longitudinal extension of a straight line). This complementary pattern 29 can be formed, for example, by both concentric rings. Other complementary patterns may also be formed by any key / keyhole shapes that match each other when viewed in the complementary viewing direction.

[0092] As shown in FIG. 2, the guide device may further include a third radiopaque sub-geometry 23. While the first and second radiopaque sub-geometry 21 and 22 in the illustrated embodiment are located at the proximal end 11, including the knob 17, the third radiopaque sub-geometry 23 is located near the distal end 12 and tip 18. As shown in FIG. 4, the third radiopaque sub-geometry 23 may include a fiducial marker 24. The third radiopaque sub-geometry 23 may also be located at the proximal end 11 and may spatially overlap the first and second radiopaque sub-geometry 21 and 22. The fiducial marker 24 may be a radiopaque sphere or other geometric shape, spatially positioned to provide a common, unique projection for any viewing direction. The concentric circles of the first and second radiopaque sub-geometry 21 and 22 allow for very accurate determination of the exact direction from proximal to distal end, and the fiducial marker 24 allows for accurate lateral determination of the spatial orientation.

[0093] 3 shows the visualization of the first radiopaque sub-geometry 21, including its unique radiographic projection 26. The radiopaque geometries 20, 21, 22, 23 allow a more accurate determination of the guide device's contour, especially when the contour of the guide device does not have high contrast. Based on the position, size, and shape of both rings of the first radiopaque sub-geometry 21, it is possible to determine the orientation of the guide device 10 and to augment and visualize the guide trajectory 16 and the path of travel 46.

[0094] The visualization and augmentation can be performed by an image processing device 30, which can be a computer or any other computing power. The image processing device here has visualization means 36 adapted to perform a virtual visualization 19 of the orientation of the guide body 15 relative to the patient's anatomy 100 based on a unique radiographic projection 25 of the radiopaque geometry 20 of the third radiopaque sub-geometry 23 including its fiducial markers 24, as shown in FIG. 4 . The unique radiographic projection 27 of the third radiopaque sub-geometry 23, in particular the pattern of the fiducial markers 24, allows for the determination of the position and orientation of the guide device. This allows for the virtual visualization 19 of the orientation of the guide body 15. The image processing device 30 further has augmentation means 38 for augmenting the guide trajectory 16 on the virtual visualization 19 of the orientation of the guide body 15 in order to visualize a movement path 46 of at least one of the surgical implant or surgical tool 45 to be implanted.

[0095] To simplify the surgeon's orientation, the augmentation means 38 can augment a reproducible scale 39 along the augmented guide trajectory 16. This scale 39 can give the surgeon an idea of ​​where the implant tip or tool tip will end up when inserted along the guide trajectory 16. This scale can also help the surgeon select the correct implant / tool ​​length. Image recognition, combined with anatomical structure identification, can suggest to the surgeon which tool or implant to use. The augmentation means can also augment the geometry associated with the implant to be implanted relative to the patient's anatomy 100 based on the unique radiographic projections 25 of the radiopaque geometry 20, and in particular the unique radiographic projections 27 of the fiducial markers 24 of the third radiopaque sub-geometry 23, as shown in FIG. 4 .

[0096] 6 and 7 show a surgical tracking system for tracking a surgical instrument 10 relative to a surgical reference 50. The surgical tracking system 2 includes an optical imaging device 70 and a light pattern 80. The imaging device 70 captures an image of the pattern 80, and since the pattern 80 has its own unique portion, size, and distortion, the relative positions of the optical imaging device 70 and the pattern 80 can be determined by recognizing the unique pattern portion. The imaging device 70 may be a camera or any other image capturing device. The imaging device may be coupled to either the surgical tool 10 or the reference 50, which is attached to the patient's anatomy. The pattern 80 may be coupled to the other of the reference 50 and the optical imaging device 70. FIG. 5 shows the optical imaging device 70 coupled to the surgical tool / instrument 10. FIG. 6 shows the light pattern 80 coupled to the reference 50. Here, the pattern 80 is printed directly on the reference 50. It should be noted that the pattern may be provided on the surgical instrument / tool ​​10, or the optical imaging device 70 may be provided on the reference 50. Both the pattern 80 and the optical imaging device 70 may be fixedly or removably coupled to the respective instrument 10 and reference body 50. The pattern 80 may be non-removably printed on the reference body 10 and discarded after use, although the optical imaging device 70 may be removably coupled to the surgical instrument 10 to reuse valuable camera equipment.

[0097] When attached to the surgical instrument 10, the imaging device 70 represents the position and orientation of the surgical instrument 10 relative to a predetermined line of sight direction 71 of the optical imaging device 70; similarly, the light pattern 80 represents the position and orientation of the surgical reference 50 relative to the unique light sub-pattern 80a. Thus, by acquiring an image from the pattern 80, the relative position and orientation of the surgical reference 50 to the position and orientation of the surgical instrument 10 can be determined. To this end, as shown in Figure 9, the system is provided with an image processing device 30 including pattern recognition means 32 and visualization means 38. Furthermore, the image processing device 30 may comprise augmentation means 36.

[0098] The image processing device 30 comprises a pattern recognition means 32 for recognizing the position and orientation of at least a light sub-pattern 80a of the light pattern 80 relative to the position of the imaging device 70 and the line of sight direction 71 based on the image captured from the imaging device 70 and the stored representation of the light pattern. Furthermore, the image processing device 30 comprises a visualization means 38 for virtually visualizing the surgical instrument 10 represented by the optical imaging device 70 and the surgical reference body 50 represented by the light pattern 80. Alternatively, the visualization means 38 virtually visualizes the surgical instrument 10 represented by the light pattern 80 and the surgical reference body 50 represented by the optical imaging device 70, depending on whether the imaging device 70 and the pattern 80 are attached to the instrument 10 or the reference body 50. If augmentation means 36 are provided, the augmentation means can augment the visualization with the instrument, the scale, and even the movement axis or trajectory of the virtual instrument or virtual implant. The augmentation items may be provided from a conversion process that converts at least two two-dimensional images into a three-dimensional image, or from virtually stored items in a database. Furthermore, additional information such as quantitative measures, implant characteristics, or identifiers may be augmented, which may help the surgeon identify the correct measurements and items. Based on the recognized position and orientation of at least the light sub-pattern 80a of the light pattern 80 relative to the position of the imaging device 70 and the line of sight direction 71, the augmentation means can augment the predetermined movement trajectory 16, 46 of the surgical instrument 10 onto the virtual visualization of the surgical instrument 10 to visualize the movement path 46 of the surgical instrument 10 relative to the surgical reference body 50 represented by the light pattern 80. This augmentation may be performed on a screen or even on an augmentation eyeglass screen worn by the surgeon during surgery.

[0099] 10 and 11 show that the optical imaging device 70 can have a mechanical interface 77a that couples to a positive-fit receptacle 17a, 57a of one of the surgical instrument 10 and the surgical reference body 50 to form a unit having a repeatable relationship between the geometry of one of the surgical instrument 10 and the surgical reference body 50 and the position and line of sight 71 of the optical imaging device 70. Similarly, the light pattern 80 can include a mechanical interface 87a that couples to a positive-fit mechanical interface 17a, 57a of one of the surgical instrument 10 and the surgical reference body 50 to form a unit having a repeatable relationship between the geometry of one of the surgical instrument 10 and the surgical reference body 50 and the position and orientation of the light pattern 80. Instead of providing a removable receptacle, the optical imaging device 70 may be fixedly connected to one of the surgical instrument 10 and the surgical reference body 50 to form a unit having a repeatable relationship between the geometry of one of the surgical instrument 10 and the surgical reference body 50 and the position and line of sight 71 of the optical imaging device 70. Similarly, the light pattern 80 may be fixedly attached to the other of the surgical instrument 10 and the surgical reference body 50 to form a unit having a repeatable relationship between the geometry of the other of the surgical instrument 10 and the surgical reference body 50 and the position and orientation of the light pattern 80.

[0100] As shown in FIG. 7 , the light pattern 80 is composed of a geometrically uniform raster 82 of light and dark fields. The fields may be square or circular, or may have a shape that somewhat fits a rectangular raster. The raster field colors can be any different colors, including printing dark or black fields on a light, white, or metallic surface (e.g., an anodized surface of an implant, tool, or reference body). In particular, square light and dark field rasters, especially light and black field rasters, can be used similarly to QR codes. Specific anchor patterns can be used to request defined subpatterns. Instead of light and dark fields or black and white fields, fields of different colors, such as red and green, yellow and blue, or yellow and black, can also be used. Alternatively, as shown in FIG. 8 , the light pattern 80 can be composed of a honeycomb raster 83 of light and dark fields. The fields may be hexagonal or circular, or may have a shape that somewhat fits a honeycomb raster. The color of the honeycomb raster field can be any different color, including printing dark or black fields on a light, white, or metallic surface (anodized surface of an implant, tool, or reference body, etc.), in particular a raster of square light and dark fields. Instead of light and dark or black and white fields, fields of different colors can also be used, for example red and green, yellow and blue, or yellow and black.

[0101] FIG. 12 illustrates the shape of a surgical reference 50 that may be aligned to a patient's anatomy 100 as shown in FIG.

[0102] The surgical reference 50 is intended for radiation-based identification as a radiopaque geometry 60 having a first radiopaque sub-geometry 61 and a second radiopaque sub-geometry 62, each sub-geometry being fixedly and spatially reproducibly connected to the surgical reference 50. The reference 50 (whose general shape is not shown here) has a first leg 51 and a second leg 52, each having an anatomically-matched surface 59 relative to the patient's anatomy 100. The anatomically-matched surfaces are shown in FIG. 13. The first leg 51, which includes a first end 51 a, is connected to a first end 52 a of the second leg 52 at a leg connection 53. Each of the first radiopaque sub-geometry 61 and the second radiopaque sub-geometry 62 has a unique radiographic projection 66, 67 for each proximal-to-distal orientation of the surgical reference body 50, thereby allowing the spatial position and orientation of the surgical reference body 50 to be determined solely from the first radiopaque sub-geometry 61 and the second radiopaque sub-geometry 62, respectively, based on two-dimensional radiographic projections of at least a portion of the surgical reference body. The radiopaque geometries may be formed by a set of fiducial markers 24, as described with respect to FIGS. 1-4, particularly FIG. 4. The radiopaque geometries of the sub-geometry 61, 62 may also be provided by a pattern 80, where, for example, the dark field of the pattern is made of a radiopaque material or paint. A first radiopaque sub-geometry 61 is assigned to the first leg 51 and a second radiopaque sub-geometry 62 is assigned to the second leg 52. In certain embodiments, the first radiopaque sub-geometry 61 is assigned to the second end 52b of the first leg 51 and the second radiopaque sub-geometry 62 is assigned to the second end 52b of the second leg 52.

[0103] FIG. 12 shows a surgical reference body 50 for referencing a patient's anatomy during surgery. The surgical reference body 50 has a radiopaque geometry 60 having a first radiopaque sub-geometry 61, a second radiopaque sub-geometry 62, and a third radiopaque sub-geometry 63. Each of the sub-geometry is fixedly and spatially repeatably connected to the surgical reference body 50. As shown in FIG. 4, the radiopaque sub-geometry can be provided as a set of fiducial markers, but can also be provided as a raster, as shown in FIG. 2 or 3, where, for example, the dark fields are made of radiopaque material and the light fields are not covered with radiopaque material. The first and second legs 51, 52 have surfaces 59 anatomically adapted to the patient's anatomy 100, as shown in FIGS. 8 and 13. First leg 51, including first end 51a, is connected to first end 52a of second leg 52 at leg interface 53. First radiopaque sub-geometry 61, second radiopaque sub-geometry 62, and third radiopaque sub-geometry 63 each have unique radiographic projections 66, 67, 68 for each proximal-to-distal orientation of surgical reference body 50, thereby allowing the spatial position and orientation of surgical reference body 50 to be determined solely from first radiopaque sub-geometry 61, second radiopaque sub-geometry 62, and third radiopaque sub-geometry 63, respectively, based on two-dimensional radiographic projections of at least a portion of the surgical reference body. A first radiopaque sub-geometry 61 is assigned to the second end 51b of the first leg 51, a second radiopaque sub-geometry 62 is assigned to the second end 52b of the second leg 52, and a third radiopaque sub-geometry is assigned to the leg junction 53 of the first leg 51 and the second leg 52.

[0104] FIG. 12 shows that the surgical reference 50 includes an apical pin hole 57. The reference 50 may also have an additional apical hole, not shown. The apical pin hole 57 here is located between the first end 52a and the second end 52b of the second leg 52. As shown in FIG. 12, at least one of the first leg 51 and the second leg 52, here the second leg 52 in FIG. 12, is composed of a first subleg 54 and a second subleg 55, with the first end 54a of the first subleg 54 corresponding to the first end 52a of the second leg 52, and the second end 54b of the first subleg 54 corresponding to the first end 55a of the second subleg 55 at the subleg interface 56. In this illustrated embodiment, the subleg interface 56 includes the apical pin hole 57. As shown in FIG. 13, the apical pin hole 57 can receive an apical pin hole. The illustrated reference body 50 may have a W-shape, with the first sub-leg 54 and second sub-leg 55 of the second leg forming the W-shape with the first leg 51. To fix the reference body 50 to the patient's anatomy, the reference body 50 may have adhesive means 58 on at least a portion of the anatomically compatible surface 59. The adhesive means may be a surface portion coated with an adhesive that is non-irritating to human skin. Alternatively, or in another surface portion, the adhesive means 58 may include a portion that is part of a touch fastener, the counterpart of which can adhere to human skin.

[0105] 14 shows a method for assisting in locating the application position of an implant / tool ​​relative to a patient's anatomy. The method includes an image processing step S30, which may include a step S32 of recognizing a pattern and a step S33 of comparing the recognized (sub)pattern with a predetermined pattern. Further, the image processing step S30 may include a step S34 of determining the position and orientation of the (sub)pattern, a step S36 of visualizing the item, and a step S38 of augmenting, for example, a guide trajectory, an outline or an illustration of the implant / tool / instrument. To provide the relative position and orientation of the optical imaging device and the light pattern, the method may include a step S70 of acquiring an optical image of the pattern using the imaging device. [Explanation of symbols]

[0106] 1 Surgical guide system for computer-assisted surgery (CAS) 2. Surgical Tracking System 10. Surgical guide devices / surgical instruments 11 Surgical guide device / proximal end of surgical instrument 12 Surgical guide device / tip of surgical instrument 15 Guide body 15a Hollow shaft guide body 15b Guide channel in guide body 16 Guide trajectory of the guide body / motion trajectory of the surgical instrument 17 Knob / Handle of Surgical Guide Device 17a Mechanical interfaces of surgical instruments for optical imaging devices or patterns 18 Surgical guide device tip 18a Surgical guide device tip blade / tool 19 Virtual visualization of the guide body / guide body orientation 20 Radiopaque Geometry of Surgical Guide Devices 21 First radiopaque sub-geometry of surgical guide device 22 Second Radiopaque Sub-Geometry of the Surgical Guide Device 23 Third Radiopaque Sub-Geometry of Surgical Guide Device 24 fiducial markers 25 Radiographic projection of the radiopaque geometry of surgical guide devices 26 Radiation projection of the first sub-geometry of the surgical guide device 27 Radiation projection of the second sub-geometry of the surgical guide device 28. Intrinsic radiographic projection of the third sub-geometry of the surgical guide device 29 Complementary patterns of the first / second sub-geometry projections 30 Image processing device 32 Recognition tools for pattern recognition 36 Visualization Tools 38 Augmentation means for augmenting the guideway 39 Reproducible scale along the augmented guideway 45 Surgical Implants / Surgical Tools 46 Inserted and guided surgical implants / Trajectory of surgical instruments / Extended trajectory of surgical instruments 50 Surgical reference body 51 First leg of surgical reference body 51a First end of first leg 51b Second end of first leg 51c Centerline of first leg 52 Second leg of surgical reference body 52a: First end of second leg 52b Second end of second leg 52c Centerline of second leg 53 Junction of the first and second legs of the surgical reference body 53c Junction of the centerlines of the first and second legs 54 First sub-leg of surgical reference body 54a First end of first sub-leg 54b: second end of first sub-leg 54c Centerline of first sub-leg 55 Second sub-leg of surgical reference body 55a: First end of second sub-leg 55b Second end of second sub-leg 55c Centerline of second sub-leg 56 Junction of the first and second sub-legs of the surgical reference body 56c Junction of centerlines of first and second sub-legs 57 Fixation hole / apical pin hole of surgical reference body 57a Mechanical interfaces of surgical reference bodies for optical imaging devices or patterns 58 Adhesion means for surgical reference body / surgical guide body 59 Anatomically adapted surfaces of the first / second (sub)legs 60 Radiopaque Geometry of Surgical Reference Bodies 61 First radiopaque sub-geometry of surgical reference body 62 Second radiopaque sub-geometry of surgical reference body 63 Third radiopaque sub-geometry of surgical reference body 64 fiducial markers 65 Intrinsic radiographic projections of the radiopaque geometry of surgical reference bodies 66 Specific radiographic projection of the first sub-geometry of the surgical reference body 67 Specific radiographic projection of the second sub-geometry of the surgical reference body 68 Unique radiographic projection of the third sub-geometry of the surgical reference body 70 Optical imaging device 71 Line of sight direction of optical imaging device 77a Mechanical interfaces of optical imaging devices for instruments or reference bodies 80 Light Patterns 80a Optical Subpattern 82 Uniform light pattern raster 83 Light Pattern Honeycomb Luster 87a Mechanical interfaces of optical imaging devices for instruments or reference bodies 100 Patient Anatomy S30 Image Processing S32 Pattern Recognition S33 Compare the recognized (sub)pattern with the given pattern S34 Determining the position and orientation of (sub)patterns S36 Visualization S38 Augmentation to increase guideway S70 Optical Image Capture

Claims

1. A surgical guide system for computer-assisted surgery (CAS), the surgical guide system (1) including a surgical guide device (10) and an image processing device (30); The surgical guide device (10) comprises: a guide body (15) having a longitudinal extension from a proximal end (11) of the surgical guide device to a distal end (12) of the surgical guide device (10), the guide body (15) being adapted to guide at least one of a longitudinal surgical implant and a longitudinal tool, the guide body (15) having a guide track (16) extending along the guide body and continuing distally along a path of travel (46) of at least one of the surgical implant and surgical tool being inserted and guided; a radiopaque geometric shape (20) disposed at a predetermined spatial location and orientation relative to said guide body (15) and adapted to provide a unique radiographic projection (25) relative to a proximal-to-distal orientation of said guide body; the radiopaque geometric shape (20) includes a third radiopaque sub-geometry (23) coupled to the distal end (12) of the guide body, the third radiopaque sub-geometry (23) including a plurality of fiducial markers (24) distributed within the third radiopaque sub-geometry (23) such that the third radiopaque sub-geometry has a unique projection (28) in each projection direction; The image processing device (30) visualization means (36) adapted to virtually visualize (19) the orientation of the guide body (15) relative to the patient's anatomy (100) based on an image comprising the radiopaque geometry (20) relative to the patient's anatomy (100) and the unique radiographic projection (25) of the radiopaque geometry (20); and augmenting means (38) adapted to augment the guide trajectory (16) on the virtual visualization (19) of the orientation of the guide body (15) so that a movement path (46) of at least one of a surgical implant or a surgical instrument is visualized; the path of travel (46) is a path along which the surgical implant or surgical tool coupled to the distal end (12) of the guide body (15) travels towards the patient; Surgical guide system.

2. The surgical guide system of claim 1 , wherein the augmentation means (38) is further adapted to augment a reproducible scale (39) along the augmented guide trajectory (16).

3. 3. The surgical guide system of claim 1, wherein the augmentation means (38) is further adapted to augment a virtual geometry associated with the guide body implanted relative to a patient's anatomy (100) based on the unique radiographic projection (25) of the radiopaque geometry (20).

4. 4. The surgical guide system of claim 1, wherein the guide body (15) comprises a hollow shaft (15a) having a guide channel (15b), the guide channel following the guide track (16).

5. The surgical guide system of any one of claims 1 to 4, wherein the guide body (15) follows a linear trajectory (16).

6. 6. The surgical guide system of claim 5, wherein the radiopaque geometric shape includes a first radiopaque sub-geometry (21) and a second radiopaque sub-geometry (22), the first radiopaque sub-geometry being provided at a proximal end (11) of the surgical guide device, and the second radiopaque sub-geometry (22) being provided at a distal end (12) of the surgical guide device, and the first radiopaque sub-geometry (21) and the second radiopaque sub-geometry (22) being arranged in parallel planes spaced apart from each other, thereby providing a radiographic projection that is distinguishable from other radiographic projections directed in directions other than the proximal end to the distal direction of the guide body.

7. A surgical guide system as described in claim 6, wherein the first radiopaque sub-geometric shape (21) and the second radiopaque sub-geometric shape (22) projected from the base end side toward the tip end side of the guide body have complementary patterns (29).

8. The surgical guide system of any one of claims 1 to 4, wherein the guide body (15) follows a curved trajectory (16).

9. an optical imaging device (70) for representing the position and orientation of one of a surgical reference (50) attachable to the surgical guide device (10) and a surgical reference (50) attachable to a patient's anatomy (100), the optical imaging device having a predetermined line of sight (71); a light pattern (80) representing the position and orientation of the other of the surgical guide device (10) and the surgical reference (50), the light pattern (80) having at least one unique optical sub-pattern (80 a) that allows for the determination of the relative position and orientation of the surgical reference (50) with respect to the position and orientation of the surgical guide device (10); an image processing device (30), The image processing device (30) a pattern recognition means (32) adapted to recognize the position and orientation of at least the optical sub-pattern (80 a) of the light pattern (80) relative to the position and line of sight (71) of the optical imaging device (70) based on an image including the light pattern acquired from the optical imaging device (70) and the stored light pattern; 9. The surgical guide system of claim 1, further comprising: a visualization means adapted to virtually visualize the surgical guide device represented by the optical imaging device and to virtually visualize a surgical reference body represented by the light pattern.

10. The image processing device (30) 10. The surgical guide system of claim 9, further comprising an augmentation means adapted to augment, based on the recognized position and orientation of the optical sub-patterns of the light pattern relative to the position and line of sight of the optical imaging device, a predetermined movement trajectory of the surgical implant or surgical tool coupled to the distal end of the surgical guide device onto the virtual visualization of the surgical guide device to visualize a movement path of the surgical guide device relative to the surgical reference and the patient's anatomical structure, respectively, represented by the light pattern.

11. The surgical guide system of claim 9 or 10, wherein the surgical guide device (10) includes the light pattern (80) so as to form a reproducible relationship between the geometric shape of the surgical guide device (10) and the position and orientation of the light pattern (80).

12. The surgical guide system of claim 9 or 10, wherein the surgical guide device (10) includes the optical imaging device (70) so as to form a reproducible relationship between the geometric shape of the surgical guide device (10) and the position and orientation of the optical imaging device (70).

13. 13. The surgical guidance system of claim 9, wherein the light pattern (80) is composed of geometrically uniform bright and dark field rasters (82), in particular square bright and dark field rasters, in particular bright and black field rasters.

14. 13. The surgical guidance system of claim 9, wherein the light pattern (80) is composed of a raster (82) of geometrically uniform fields of different colors, in particular a raster of square color fields, in particular a raster of color gradient fields.

15. 13. The surgical guide system of claim 9, wherein the light pattern (80) is composed of a honeycomb raster (83) of light and dark fields, in particular a raster of light and dark circles or light and dark hexagons within the honeycomb raster (83), in particular a raster of light and black circles or light and dark hexagons.

16. 13. The surgical guide system of claim 9, wherein the light pattern (80) is composed of a honeycomb raster (83) of different color fields, in particular a raster of colored circles or hexagons within the honeycomb raster (83), in particular a raster of color gradient circles or hexagons.

17. A surgical guide system as described in any one of claims 9 to 16, wherein the surgical reference body (50) is attached to the optical imaging device (70) or the light pattern (80), and the surgical guide system further includes a surgical reference body (50) that can be attached to the patient's anatomical structure (100).

18. The surgical reference (50) a radiopaque geometric shape (60) fixedly connected to said surgical reference (50); a reference body part (51) having a surface (59) attached to the patient's anatomy (100); 18. The surgical guide system of claim 17, wherein the radiopaque geometric shape (60) has unique radiographic projections (66, 67, 68) for each proximal-to-distal orientation of the surgical reference body (50), and the radiopaque geometric shape (60) enables determination of the position and orientation of the surgical reference body (50) relative to the anatomical structure based on two-dimensional radiographic projections of at least a portion of the surgical reference body.

19. The surgical reference (50) a radiopaque geometry (60) having a first radiopaque sub-geometry (61) and a second radiopaque sub-geometry (62), each sub-geometry being fixedly connected to the surgical reference (50); a first reference body part (51) having a surface (59) attached to a patient's anatomy (100); a second reference body part (52) having a surface (59) attached to the patient's anatomy (100); each of the first radiopaque sub-geometry (61) and the second radiopaque sub-geometry (62) having a unique radiographic projection (66, 67, 68) for each proximal-to-distal orientation of the surgical reference (50); and wherein the spatial position and orientation of the surgical reference (50) can be determined solely from each of the first radiopaque sub-geometry (61) and the second radiopaque sub-geometry (62) based on two-dimensional radiographic projections of at least a portion of the surgical reference; The surgical guide system of claim 17, wherein the first radiopaque sub-geometry (61) is assigned to the first reference body portion (51) and the second radiopaque sub-geometry (62) is assigned to the second reference body portion (52).

20. The surgical reference (50) a radiopaque geometry (60) having a first radiopaque sub-geometry (61), a second radiopaque sub-geometry (62), and a third radiopaque sub-geometry (63), each sub-geometry being fixedly connected to the surgical reference (50); a first leg (51) having a surface (59) attached to the patient's anatomy (100); a second leg (52) having a surface (59) attached to the patient's anatomy (100); The first leg (51) having a first end (51a) is connected to a first end (52a) of the second leg (52) at a leg joint (53); each of the first radiopaque sub-geometry (61), the second radiopaque sub-geometry (62), and the third radiopaque sub-geometry (63) has a unique radiographic projection (66, 67, 68) for each proximal-to-distal orientation of the surgical reference (50); and the first radiopaque sub-geometry (61), the second radiopaque sub-geometry (62), and the third radiopaque sub-geometry (63), respectively, are sufficient to determine the spatial position and orientation of the surgical reference (50) based on the two-dimensional radiographic projection of at least a portion of the surgical reference (50); 18. The surgical guide system of claim 17, wherein the first radiopaque sub-geometry (61) is assigned to a second end (51b) of the first leg (51), the second radiopaque sub-geometry (62) is assigned to a second end (52b) of the second leg (52), and the third radiopaque sub-geometry (63) is assigned to the leg junction portion (53) of the first leg (51) and the second leg (52).

21. The surgical guide system of claim 20, wherein the surgical reference (50) includes at least one apical pin hole (57).

22. 22. The surgical guide system of claim 21, wherein the at least one apical pin hole (57) is located between a first end (51a / 52a) and a second end (51b / 52b) of at least one of the first leg (51) and the second leg (52).

23. 23. The surgical guide system of claim 22, wherein the first leg (51) or the second leg (52) includes a first sub-leg (54) and a second sub-leg (55), a first end (54a) of the first sub-leg (54) corresponds to the first end (51a / 52a) of at least one of the first leg (51) and the second leg (52), and a second end (54b) of the first sub-leg (54) joins to the first end (55a) of the second sub-leg (55) to form a sub-leg joining portion (56).

24. The surgical guide system of claim 23, wherein the sub-leg interface (56) includes at least one of the at least one apical pin hole (57).

25. 25. The surgical guide system of claim 20, wherein the included angle between the first leg (51) and the second leg (52) at the junction (53c) between the first leg (51) and the second leg (52) is less than 90°, in particular less than 60°.

26. 26. The surgical guide system of claim 23, wherein one of the first leg (51) and the second leg, and the first sub-leg (54) and the second sub-leg (55) of the other of the first leg (51) and the second leg (52) form a W-shape.

27. 27. The surgical guide system of any one of claims 23 to 26, wherein at least a portion of a surface (59) of either the first leg (51) or the second leg (52) comprises adhesive means (58).

28. 28. The surgical guide system of claim 27, wherein the adhesive means (58) comprises a portion that is a surface portion coated with an adhesive that is non-irritating to human skin.

29. 29. The surgical guide system of claim 27 or 28, wherein the adhesive means (58) comprises a portion that is part of a touch fastener, another portion of which is capable of adhering to human skin.

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