Alignment device

Abstract

This is a device for aligning a guide wire to bone. The device comprises at least one upper jaw portion configured to contact a portion of the bone, at least two lower jaw portions configured to contact different portions of the bone, and a guide member configured to align the guide wire to the bone. The positions of the at least one upper jaw portion, at least one of the at least two lower jaw portions, and the guide member are each independently adjustable.

Description

Technical Field

[0001] The present disclosure relates to an alignment device, particularly an alignment device for aligning a guide wire to a bone. The present disclosure also relates to a method of setting an alignment device for aligning a guide wire to a bone.

Background Art

[0002] During hip resurfacing, the femoral head is retained and covered with a head implant having a spherical bearing of a size similar to that of the natural joint. The acetabular fossa of the pelvis is reamed to a substantially hemispherical shape, and a thin-walled cup implant is fitted, so that the hip joint is completely reconstructed by an artificial bearing.

[0003] In order to restore the natural range of motion and ensure that the bearing functions well over a long period, it is very important to correctly position both the head implant and the cup implant relative to the natural bone and soft tissue structures. This is particularly difficult in diseased hip joints where the femoral head is often deformed and the position of the acetabular fossa is slightly displaced. This can cause misalignment of the implant components. Furthermore, the surgeon may have difficulty visually identifying anatomical landmarks and determining the orientation of the bone due to limited access and visibility during the operation.

[0004] When a surgeon positions a resurfacing head implant in the femur, the following factors are considered: Firstly, femoral head / neck size is considered: the size of the head implant should be approximately the same as the size of the natural femoral head, and at the same time, there must be sufficient bone in the femoral head to fully support the implant, and it is important that the cutter used to prepare the femoral head does not erode the femoral neck (known as notching), as this weakens the bone and can lead to a postoperative femoral neck fracture. Secondly, the varus / valgus angle is considered: this is the angle between the femoral axis and the femoral head implant axis, and should be within the range of 135 to 145 degrees so that the load is transmitted through the implant without placing excessive stress on the bone. Thirdly, the version angle is considered: this is the anterior inclination angle of the femoral neck relative to the frontal anatomical plane. This is unique to each patient and is usually within the range of 15 to 25 degrees. The surgeon attempts to position the femoral head axis to match the version angle of the individual patient's natural femoral neck.

[0005] Patient-specific guides are sometimes used in joint replacement surgery to assist in implant positioning. The guides are defined and constructed preoperatively based on a three-dimensional digital image of the patient's joint. The digital image of the patient's joint can be reconstructed from the patient's medical scan data using commercially available computer-aided design (CAD) and / or other specialized planning software. The surgeon or skilled technician operates the software to position the implant in the desired location relative to the scanned bone of the patient. Subsequently, a patient-fit guide is defined and constructed using rapid prototyping techniques such as SLS additive manufacturing. These guides are designed to precisely conform to the patient's exposed bone surface during surgery, allowing for accurate guidance of the implant to the planned position.

[0006] The advantage of patient-specific head guides for surface replacement heads is that, because the guide precisely fits to a specific position on the femur, the size of the femoral head / neck, varus / valgus angle, and version angle can be adjusted simultaneously according to the preoperative plan. However, the disadvantage is that these patient-specific head guides require time to prepare from planning to the day of surgery, usually at least one to two weeks. Furthermore, these patient-specific head guides may incur considerable additional costs.

[0007] Preoperative planning using digital templating with X-rays can be used to determine the size and approximate position of implants. However, the planning is carried out solely through intraoperative sensory evaluation, such as visually comparing the two-dimensional plan displayed on the operating room screen with the actual guide and implant. Therefore, it is difficult to achieve the appropriate implant size and position with sufficient precision. [Overview of the project] [Problems that the invention aims to solve]

[0008] This disclosure was devised to mitigate or overcome at least some of the problems described above. [Means for solving the problem]

[0009] According to a first aspect of the present disclosure, a device is provided for aligning a guidewire to bone, the device comprising at least one maxillary portion configured to contact a portion of bone, at least two lower jaw portions configured to contact different portions of bone, and a guide member configured to align a guidewire to bone, wherein the position of at least one of the at least two lower jaw portions and the guide member, and optionally the position of at least one maxillary portion, are independently adjustable.

[0010] The proposed device may provide a means for aligning a guidewire to bone, for example, to the femur, with the same precision as currently used patient-specific head guides. Advantageously, the proposed device may provide such a means for aligning a guidewire to bone without the additional time, cost, and complex logistics required to prepare and use a patient-specific head guide.

[0011] Preferably, at least one of the lower jaw portions and optionally at least one of the upper jaw portions are movable relative to the longitudinal axis of the device, and at least one of the upper jaw portions is movable away from or towards at least two of the lower jaw portions, and the guide members are angle-adjustable. Thus, the jaw portions can be moved or adjusted according to the patient's specific requirements, and the angle of the guide members can be adjusted to properly position the guide wires in the bone. Advantageously, by adjusting the components, the proposed device can accommodate bones of any shape.

[0012] The device preferably further comprises a centering element for maintaining the central position of the guide member between at least one upper jaw portion and at least two lower jaw portions. The centering element can advantageously facilitate the central positioning of the guide wire, for example, within the femoral neck of the femur.

[0013] Preferably, the apparatus further comprises a frame comprising a central body for supporting a guide member, a first lateral portion for supporting at least one upper jaw portion, and a second lateral portion for supporting at least two lower jaw portions, wherein the first and second lateral portions are arranged to move parallel to each other so that at least one upper jaw portion can move relative to at least two lower jaw portions. The frame may provide means for more easily adjusting the position of each component. Furthermore, the frame may provide a rigid structure for supporting the components of the apparatus, thereby advantageously minimizing positional deviations of each component.

[0014] In some embodiments, translation is provided by displacement means arranged to move the first and second lateral portions relative to each other. Advantageously, at least one upper jaw portion can be easily separated or moved apart from at least two lower jaw portions, thereby facilitating adjustment of the device to the specific patient requirements.

[0015] Preferably, the frame further provides a centering element for maintaining the central position of the guide member between at least one upper jaw portion and at least two lower jaw portions. In particular, it is preferable that a displacement means provides this centering element.

[0016] In some embodiments, the displacement means comprises a scissor clamp mechanism connecting the central body to the first and second lateral sections. The scissor clamp mechanism can advantageously provide a compact and smooth means for facilitating the parallel movement of at least one upper jaw and at least two lower jaws. The scissor clamp may additionally provide a centering element function, where the central body (supporting the guide member) maintains a central position between the first lateral section (supporting at least one upper jaw) and the second lateral section (supporting at least two lower jaws).

[0017] In some embodiments, the displacement means comprises a gear arrangement having a circular gear that engages with a first linear gear and a second linear gear, the circular gear being connected to a central body, the first linear gear to a first side, and the second linear gear to a second side. The gear arrangement can advantageously provide means for separating the first side from the second side while maintaining the central position of the central body. The displacement means may comprise multiple such gear arrangements to facilitate secure connections between the central body, the first side, and the second side.

[0018] In some embodiments, the guide member is rotatably connected to the central body. Therefore, the angle of the guide member relative to the central body can be easily adjusted. By rotating relative to the central body, the angle of the guide member can be more appropriately matched to the insertion angle of the wire into the bone.

[0019] In some embodiments, the pivot point of the guide member is projected onto a virtual position, which lies on the central axis of the central body. This projection of the pivot point of the guide member may be beneficial when soft tissue is present where the pivot point is needed, particularly when the device is used in an anterior surgical approach.

[0020] At least one upper jaw can be fixed with respect to longitudinal movement, but in some embodiments, at least one upper jaw is slidably connected to the frame so that it can move along the longitudinal axis of the frame. Advantageously, providing means for moving at least one upper jaw along the longitudinal axis of the frame may provide additional degrees of freedom for changing the position of at least one upper jaw. In particular, at least one upper jaw can move along the longitudinal axis via a slidable connection, and can also move along an axis perpendicular to the longitudinal axis via a displacement means.

[0021] In some embodiments, at least one upper jaw is connected to the frame via a first connecting means, and at least two lower jaws are connected to the frame via a second connecting means, with the first and second connecting means being incompatible. This allows at least one upper jaw to be connected to the frame only at the location where the corresponding first connecting means portion is positioned. In particular, because the first and second connecting means are incompatible, at least one upper jaw cannot be connected to the frame via the second connecting means. Similarly, at least two lower jaws cannot be connected to the frame via the first connecting means portion. This is advantageous because each jaw cannot be connected at incompatible locations, making it easier to assemble the device in the correct position more quickly. Furthermore, it can help avoid assembly errors and reduce confusion.

[0022] In some embodiments, the at least two lower jaws comprise a fixed jaw and a movable jaw, the movable jaw being slidably connected to the fixed jaw so that the movable jaw can move relative to the fixed jaw. This allows for easier positioning of the at least two lower jaws by sliding the movable jaw. Furthermore, the at least two lower jaws may require only a single connection point to the frame, thereby improving the simplicity of the device. In addition, since only the movable jaw of the at least two lower jaws moves, the ease of setting up the device is improved by reducing the number of setup parameters.

[0023] In some embodiments, the device further includes a displacement gauge for determining the maxillary position. Advantageously, the device can provide means for more easily positioning at least one upper jaw portion.

[0024] In some embodiments, the device further includes a separation gauge for measuring the distance between at least two lower jaw portions. Advantageously, the device can provide means for more easily positioning at least two lower jaw portions.

[0025] In some embodiments, the device further includes an angle gauge for measuring the angle of the guide member relative to the longitudinal axis of the device. Advantageously, the device can provide means for more easily positioning the guide member.

[0026] In some embodiments, the device further includes locking means for preventing the jaws from moving away from the longitudinal axis of the device. Advantageously, the locking means can prevent the jaws from deviating from the intended or positioned position once set.

[0027] According to a second aspect of the present disclosure, a preoperative planning method of setting a device for aligning a guide wire with bone is provided, the method including accessing image data of an image of the bone, identifying one or more positioning parameters based on the image data, and adjusting the device based on the one or more positioning parameters.

[0028] The preoperative planning method can provide means for determining the placement of the device before use. The accuracy provided by such a method can be higher than existing digital template processing that requires a visual comparison of the 2D plan displayed on the operating room screen with the actual guide and implant.

[0029] In some embodiments, identifying one or more positioning parameters includes generating a digital template, overlaying the digital template on an image of the bone, determining the appropriate position of the digital template, identifying one or more positioning points, and identifying one or more positioning parameters based on the one or more positioning points. The digital template can advantageously provide means for more easily determining one or more positioning parameters.

[0030] In some embodiments, the digital template includes an assist overlay. The assist overlay can provide assistance in determining the proper position of the digital template. More specifically, the assist overlay can communicate the valgus-valgus angle (or stem-shaft axis angle), which is a critical angle for determining the proper position of the digital template.

[0031] In some embodiments, identifying one or more positioning parameters based on one or more positioning points includes generating a second digital template, aligning the second digital template with one or more positioning points, and identifying one or more positioning parameters based on the positions of one or more positioning points relative to the second digital template.

[0032] In some embodiments, the device is the device of the first embodiment of the present disclosure. In some embodiments, one or more positioning parameters include mandibular spacing, maxillary position, and guide member angle. Thus, the proposed preoperative planning method can be used to determine the position of at least one maxillary portion, at least two mandibular portions, and guide member of the device of the first embodiment of the present disclosure. Advantageously, the device can be adequately calibrated before the procedure in which the guide wire is inserted into the bone.

[0033] It will be understood that any features described herein that are suitable for incorporation into one or more aspects or embodiments of the Disclosure are intended to be generalizable across any and all aspects and embodiments of the Disclosure. Other aspects of the Disclosure may be understood by those skilled in the art in light of the description, claims and drawings of the Disclosure. The above general description and the following detailed description are illustrative and descriptive only and do not limit the claims. [Brief explanation of the drawing]

[0034] One or more embodiments of this disclosure are described below, by reference only to the accompanying drawings.

[0035] [Figure 1] Figure 1 shows an isometric view of a head guide according to a first aspect of this disclosure. [Figure 2A] Figure 2A shows a plan view of the head guide. [Figure 2B] Figure 2B shows a plan view of a head guide according to another embodiment. [Figure 3] Figure 3 shows an exploded isometric view of the head guide with removable jaw subassemblies for the left and right hip joints. [Figure 4] Figure 4 shows an isometric view of the jaw subassembly for the left hip joint using a posterior approach. [Figure 5] Figure 5 shows an isometric view of the head guide with the jaw subassembly for the left hip joint installed via a posterior approach. [Figure 6] Figure 6 shows a front view of the head guide with the jaw subassembly installed. [Figure 7] Figure 7 shows an isometric view of the head guide with the jaw subassembly clamped to the right femur via a posterior approach. [Figure 8] Figure 8 shows a digital X-ray image including the surface replacement head template. [Figure 9] Figure 9 shows a digital X-ray image with the head template and three dots added. [Figure 10] Figure 10 shows an additional template with scales and lines marked on it. [Figure 11] Figure 11 shows a digital X-ray image with both templates superimposed. [Figure 12] Figure 12 shows a digital X-ray image in which both templates are superimposed and additional angle measurements have been taken. [Figure 13] Figure 13 shows a digital X-ray image with the head template and various lines and measurements added. [Figure 14A]Figure 14A shows a flowchart of a preoperative planning process for setting up a device for aligning a guidewire with bone, according to a second aspect of the present disclosure. [Figure 14B] Figure 14B shows a flowchart of the substeps for identifying one or more positioning parameters.

[0036] Please note that the drawings are schematic and supplementary to the explanation, illustrating preferred and exemplary embodiments, and are not necessarily drawn to scale. [Modes for carrying out the invention]

[0037] (Head guide) This disclosure provides a device for aligning a guidewire with bone.

[0038] Figure 1 shows an isometric view of the apparatus according to a first aspect of the present disclosure, more specifically, of the head guide 1. Figure 2A shows a plan view of the head guide 1.

[0039] The head guide 1 comprises a frame having a central body 2 connected to a first side portion 3 and a second side portion 4.

[0040] The first side portion 3 and the second side portion 4 are arranged to translate parallel to each other. The translation is provided by displacement means arranged to move the first side portion 3 and the second side portion 4 relative to each other.

[0041] The displacement mechanism includes a scissor clamp mechanism connecting the central body 2 to the first side portion 3 and the second side portion 4. The scissor clamp mechanism comprises a pair of tines 5 and a pair of cross members 6, the tines 5 and cross members 6 arranged in a crisscross configuration, and the tines 5 are fixed to the cross members 6 at a plurality of fixed positions 7. At the fixed positions 7, the pair of tines 5 are connected to the pair of cross members 6 via pins that facilitate the rotation of the tines 5 relative to the cross members 6. In the illustrated example, there are eight fixed positions 7.

[0042] To provide movement of the first side 3 and the second side 4 relative to each other, the central body 2, the first side 3, and the second side 4 each have slots 8 in which their respective pins 7 are positioned and guided. The pins 7 attached to the tines 5 occupy the slots 8 in the first side 3 and the second side 4, while the pins 7 attached to the cross members 6 occupy the slots 8 in the central body 2. The pins 7 traverse the guides 8, allowing the tines 5 and the cross members 6 to extend and retract as the head guide 1 opens and closes. Thus, the displacement means allows the tines 5 and the cross members 6 to extend and retract along their axes. In particular, the first side 3 and the second side 4 remain parallel to the central body 2 and remain equidistant from the central body 2.

[0043] Another displacement mechanism is shown in Figure 2B, which shows a plan view of the head guide 1 in an alternative embodiment. The displacement mechanism has a gear arrangement having a circular gear 101 that meshes with a first linear gear 102 and a second linear gear 103, the circular gear 101 being connected to a central body 2, the first linear gear 102 being connected to a first side 3, and the second linear gear being connected to a second side 4. The first side 3 and the second side 4 are provided with slots or undercuts 104 for receiving opposing linear gears, which can achieve a more compact configuration.

[0044] Movement of one side, for example, when the first side 3 moves to the left in Figure 2B, causes a corresponding rotation of the circular gear 101 via the meshing of the first linear gear 102 with the circular gear 101. The rotation of the circular gear 101 causes the corresponding movement of the second linear gear 103, but on the opposite side (i.e., to the right in this example), and thus provides a gap between the first side and the second side. Through this gap, the central body 2 maintains its central position between the first side 3 and the second side 4.

[0045] The displacement means comprises two such gear arrangements, the first of which is close to the first end of the central body 2, and the second of which is close to the second end of the central body 2.

[0046] The head guide 1 further comprises a gripping means. The gripping means may allow the user to open and close the head guide 1 more easily. The gripping means comprises a loop 9 or a pair of loops 9, each extending from the distal end of each tine 5. Thus, the head guide 1 can be gripped like scissors, with the index finger and thumb typically occupying the respective loops 10. The loops 9 are provided with external tabs 10 for resting another finger to enhance stability.

[0047] The head guide 1 further comprises locking means for fixing the first side portion 3 and the second side portion 4 in specific displacements. The locking means may comprise a ratchet arm 11 and a pawl 12. The ratchet arm 11 is rotatably mounted on the first side portion 3 and engages with the pawl 12 mounted on the second side portion 4 to hold the side portion in place when gripped and squeezed together with the fingers. The ratchet arm 11 is equipped with an integrated leaf spring 13 that biases the ratchet arm 11 to engage with the pawl 12, so that when the head guide 1 is closed, the ratchet arm 11 automatically engages and holds. This makes it possible to clamp the head guide 1 around the femoral neck, as will be described later. The ratchet arm 11 is released by pushing the ratchet arm 11 away from the pawl 12 against the light spring pressure provided by the leaf spring 13, and at the same time spreading the gripping portion outward to open the head guide 1.

[0048] The head guide 1 further comprises a guide member. In this example, the guide member is a swing arm 16. The swing arm 16 is supported by the central body 2 via locking means such as a fixing screw 17. The swing arm 16 remains attached to the central body 2 via an undercut 18 that engages with a flange 19 adjacent to the second end of the central body 2. The swing arm 16 moves in a rotational arc and can be fixed in any position with the fixing screw 17.

[0049] The head guide 1 further includes an angle gauge for measuring the angle of the guide member with respect to the longitudinal axis of the device (i.e., the angle of guide wire insertion). The central body 2 includes a protractor 15 near the first end of the central body 2. The protractor 15 has a 90-degree angle scale at its center, symmetrical increments, and scales at 5 and 10 degrees from the center. The head guide 1 further includes an angle indicator for clearly indicating the insertion angle.

[0050] Typically, the swing arm 16 can be locked in 1-degree increments (for example, via a fixing screw 17) on either side of the 90-degree central position. The protractor 15 includes retaining means to prevent the swing arm 16 from completely detaching from the protractor 15. The retaining means comprises one or more retaining pins 20. In this example, the angle indicator is a visual indicator positioned on the swing arm 16. The visual indicator is a line or notch positioned to align with the angle scale on the protractor 15.

[0051] The swingarm 16 includes a guide tube 21 mounted below the swingarm 16 and parallel to the swingarm 16. A drill guide 22 having a spike end 23 passes through the guide tube 21 and is housed within the guide tube 21. At a 90-degree position, the drill guide 22 is positioned parallel and centrally between the first side 3 and the second side 4.

[0052] As shown in Figure 2, the curved surface 24 into which the central body 2 and the swing arm 16 engage projects the pivot point of the swing arm 16 to a virtual position 25 at the center of the radius of curvature 26. At this position, the axis 27 of the central body 2 and the axis 28 of the drill guide 22 coincide at all protractor positions. This position is maintained centrally between the three jaw grips, which will be described later.

[0053] The head guide 1 further includes a displacement gauge for measuring the position of the upper jaw. More specifically, the displacement gauge is for measuring the position of the upper jaw relative to the longitudinal axis of the head guide 1. At least one of the first lateral section 3 and the second lateral section 4 is equipped with a displacement gauge. In this embodiment, both the first lateral section 3 and the second lateral section 4 are equipped with a displacement gauge. In particular, the first lateral section 3 and the second lateral section 4 each include a letter scale 14 labeled with letters A through L. The function of this letter scale 14 will become more apparent when the jaw subassembly is attached, as will be described later. Because both sides are equipped with displacement gauges, upper jaws with different orientations (e.g., for different surgical approaches and / or hip joints) are compatible with the head guide 1.

[0054] Before using head guide 1, the jaw subassembly is attached to head guide 1 to align the guidewire with the bone.

[0055] Figure 3 shows an exploded isometric view of head guide 1 with removable jaw subassemblies for the left and right hip joints. Figure 4 shows an isometric view of the jaw subassembly for the left hip joint via a posterior approach. Figure 5 shows an isometric view of head guide 1 with the jaw subassembly for the left hip joint installed via a posterior approach. Figure 6 shows a front view of head guide 1 with the jaw subassembly installed.

[0056] As shown in Figures 3 to 6, a pair of jaw subassemblies are attached to the head guide 1 before use. Depending on the surgical approach and the hip side of the surgical target, one or the other jaw subassembly is used. Figure 3 shows both jaw subassemblies in their pair, along with dotted lines indicating their placement on the head guide 1.

[0057] The jaw subassemblies are positioned at their respective locations via placement means. The placement means comprises screws and corresponding screw receivers. In the case of a posterior surgical approach, the first jaw pair 29 is used for the left hip joint, and the second jaw pair 30 is used for the right hip joint. The anterior surgical approach is on the opposite side of the hip joint, and therefore the second jaw pair 30 is used for the left hip joint, and the first jaw pair 29 is used for the right hip joint.

[0058] Referring to Figure 4, the first jaw pair 29 comprises an upper jaw subassembly 32 labeled "SUP" and a lower jaw subassembly 33 labeled "INF".

[0059] The upper jaw subassembly 32 comprises a single jaw portion 34. The jaw portion 34 comprises a flat body portion 37 and a curved grip portion 38 extending away from the body portion 37 (for example, at a 90-degree angle to the body portion 37). When mounted on the frame of the head guide 1, the upper jaw subassembly 32 is supported by a first side portion 3 (or a second side portion 4 depending on the surgical approach). The upper jaw subassembly can be slidably connected to the frame so that the upper jaw portion can move relative to the frame (i.e., along the longitudinal axis). In particular, the body portion 37 can be slidably attached to the first side portion 3 of the head guide 1 via a screw held in a slot 36 and a corresponding thread located on the head guide 1. The grip portion 38 is positioned to grasp the upper part of the femoral neck when in use.

[0060] The main body 37 is equipped with a position indicator for showing its position on the head guide 1. In particular, the upper surface of the main body 37 is equipped with a window 41 having a central mark that indicates the position along the displacement gauge (i.e., the letter scale 14). The main body 37 is also equipped with a gripping means such as a textured grip. The main body 37 is also equipped with a visual indicator of a plus sign 42.

[0061] The lower jaw subassembly 33 comprises a fixed jaw portion 43 and a movable jaw portion 44. Both jaw portions 43, 44 include a flat body portion 45 and a curved grip portion 46 extending away from the body portion 45 (for example, at a 90-degree angle to the body portion 45). The body portion 45 of the movable jaw portion is positioned on top of the body portion 45 of the fixed jaw portion.

[0062] The fixed jaw portion 43 and the movable jaw portion 44 are connected via connecting means. The movable jaw portion 44 is slidably connected to the fixed jaw portion 43 so that the movable jaw portion 44 can move relative to the fixed jaw portion 43. The connecting means includes a screw 47 that passes through a hole in the fixed jaw portion 43 and a slot 48 in the movable jaw portion 44. The main body portion 45 of the fixed jaw portion is attached to the frame of the head guide 1, and the two grip portions 46 are positioned to grip around the lower part of the femoral neck when in use. When attached to the head guide 1, the two grip portions 46 are aligned with each other, but the distance between them is variable.

[0063] The head guide 1 includes a separation gauge for measuring the displacement of the movable jaw portion 44 relative to the fixed jaw portion 43. For example, the fixed jaw portion 43 has a measuring scale 50 in millimeters. The main body portion 45 of the movable jaw portion 44 has a tapered end portion 52 that allows the measuring scale 50 to be read. A notch 53 in the main body portion 45 of the movable jaw portion 44 makes the dimensional numbers clearly visible when reading the scale.

[0064] The upper surface of the main body 45 of the movable jaw section 44 has a textured grip. The measuring scale 50 directly indicates the distance between the jaw grips (distance between the centers of the grips).

[0065] To avoid errors, the jaw subassemblies are provided with indicators to ensure that the jaw subassemblies are assembled in the correct pairs. The indicators may include visual indicators for recognition purposes. For example, the first jaw pair 29 is provided with a triangular symbol, and the second jaw pair 30 is provided with a circular symbol. In this example, these symbols are placed on their respective threads.

[0066] Furthermore, to avoid errors, the jaw subassemblies are equipped with position indicators to ensure that the jaw subassemblies are assembled in the correct position on the head guide 1. For example, two different connecting means are used for each jaw subassembly of a pair of jaw subassemblies. In particular, taking the first jaw pair 29 as an example, the upper jaw subassembly 32 is connected to the frame via a first connecting means, and the lower jaw subassembly 33 is connected to the frame via a second connecting means, and the first and second connecting means are not interchangeable. More specifically, the first connecting means comprises a screw 35 positioned to engage with a corresponding first female thread on the first side 3. The second connecting means comprises a screw 47 positioned to engage with a corresponding second female thread on the second side 4. The female threads are dimensioned so that only corresponding threads can be mated. Therefore, screw 35 is incompatible with the female thread of the second side 4, and vice versa, and the first jaw pair 29 can only be assembled in the correct position where the jaw grips 38, 46 form an inward-facing circle. Screw 35 and the first female thread are of a first size (e.g., M6), and screw 47 and the second female thread are of a second size (e.g., M8).

[0067] Figure 5 shows the head guide 1 with the first jaw pair 29 assembled. The upper jaw 32 is slidably adjustable on the second lateral 4 and can be locked in place by tightening the screw 35. The letters in window 41 indicate the set position (in this case, position "E").

[0068] The lower fixed jaw section 43 is in a fixed position but remains loose until the screw 47 is tightened. The movable jaw section 44 is slidably adjustable to change the distance between the two lower grip sections 46. The distance between the grip centers is indicated by a measuring scale 50. Both jaw sections are firmly locked in place by tightening the screw 47. The lower jaw grips 46 align with each other and remain parallel to the central body 2 as they slide through the adjustment range.

[0069] Figure 6 shows that, when viewed from the front, the drill guide shaft 55 is centrally positioned relative to the grip portions 38 and 46 of the jaw section. This is true for any open / closed position and all adjustment positions of the head guide 1.

[0070] Figure 7 shows the assembled head guide 1 clamped to the femur 57 with the swing arm 16 positioned at 88 degrees (indicated by the angle indicator). The head guide 1 is clamped in a stable position with all three jaws 34, 43, and 44 gripping around the femoral neck 58. The guide wire 59 is inserted into the drill guide 22 and partially drilled into the femur 57. As described above, the head guide 1 is set so that the guide wire passes through the center of the femoral neck.

[0071] The grip portions 38, 46 of all three jaw portions 34, 43, 44 are shaped to at least partially conform to the shape and / or angle of the bone during positioning. Such shaping helps to position the implant at a natural angle. An expert will recognize the appropriate shape of the grip portion that allows for the configuration of the device along the angle of the bone. For example, the grip portion may be crescent-shaped and curved inward, allowing it to grasp around the nearly elliptical cross-section of the femoral neck. Further jaw portions may be conceivable (e.g., V-shaped, U-shaped, etc.). The two lower jaw portions 43, 44 are spaced apart to take the natural angle of the lower part of the femoral neck in the coronal (frontal) plane. In addition, the spaced jaw portions take the natural anteversion angle (version angle) (a slightly forward-tilted angle) of the femoral neck relative to the coronal plane. The angle of guidewire insertion can be fine-tuned as follows: The 90-degree position of the angle measuring means is precisely aligned with the two lower jaw portions 43 and 44, and therefore also aligned with the lower femoral neck. An angle 12 degrees above 90 degrees (on the positive side of the scale) is more valgus (or perpendicular) to the lower femoral neck. An angle of 12 degrees below 90 degrees (the negative end of the scale) is more varus (or horizontal) relative to the lower femoral neck.

[0072] When the device is in position on the bone during use, it is important that at least both of the lower jaw portions are in contact with the bone. With the two lower jaw portions in position on the bone, the axial angle of the head implant can be precisely set / fixed. The upper jaw portion effectively functions as an anchor and can be positioned along any portion of the bone opposite to the side where at least two lower jaw portions are located. The parallel movement of the upper and lower jaw portions toward each other to grasp the bone ensures that each jaw portion contacts the bone in the desired position and that the angle of the guide members is accurate.

[0073] (Preoperative planning procedures) This disclosure also provides a preoperative planning method for planning or determining the jaw gripping position to achieve a desired position of the head implant. The planning can be performed either preoperatively or intraoperatively in total hip arthroplasty. This method is performed both to determine the size of the implant and to plan its position. The plan is accessible in the operating room, referenced during surgery, and / or, in some cases, modified. Programs for preoperative planning include TraumaCAD Digital Orthopedic Templating (Brainlab AG Munich) and Orthoplan 2.0 (Radlink Inc).

[0074] Figure 14A shows a flowchart of the preoperative planning process 1400 for setting up the device for aligning the guidewire to the bone.

[0075] To illustrate the preoperative planning method 1400, we will describe an example of setting up the head guide 1 to align the guidewire 59 with the femur 57.

[0076] Step 1402 of the preoperative planning method 1400 includes accessing image data of bone images. The image data may be any suitable image data, such as 2D or 3D image data. The image data may reside in a data file accessible by a computing device. The image data may be captured and immediately uploaded to a computing device for access. The image data may be captured by any suitable image capture device, such as an X-ray detector, and uploaded to a suitable image processing means, such as TraumaCAD. It is preferable to use X-ray images because parameters can be more easily identified, as will be further explained below.

[0077] In this example, image data of femur 57 is accessed. Figure 8 shows a 2D X-ray image of femur 57. The X-ray images may be captured at any point prior to the preoperative planning processing method 1400, but it may be advantageous to use recently captured image data.

[0078] Step 1404 of the preoperative planning processing method 1400 includes identifying one or more positioning parameters based on image data obtained from bone images.

[0079] In the context of this example, the head guide 1, which aligns the guidewire 59 to the femur 57, has one or more positioning parameters, including the lower jaw distance, the upper jaw position, and the guide member angle. The lower jaw distance corresponds to the distance between the fixed jaw 43 and the movable jaw 44, as indicated, for example, by a second separation gauge (i.e., measuring scale 50). The upper jaw position corresponds to the position of the upper jaw 34 relative to the longitudinal axis of the head guide 1, as indicated, for example, by a displacement gauge (i.e., letter scale 14). The guide member angle corresponds to the angle of the guide member relative to the longitudinal axis of the device, as indicated, for example, by an angle gauge (i.e., protractor 15).

[0080] Identifying one or more positioning parameters includes the following substeps, as shown in Figure 14B: generating a digital template 1404A, overlaying the digital template onto an image of bone 1404B, determining the appropriate position of the digital template 1404C, identifying one or more positioning points 1404D, and identifying one or more positioning parameters based on one or more positioning points 1404E.

[0081] Generating a digital template 1404A may include receiving user input and generating a digital template based on the user input. User input may include selecting a digital template from a predefined set of digital templates.

[0082] In this example, the digital template is a digital template for a surface replacement head implant for the femur. Figure 8 shows the digital template of the 1404B surface replacement head implant 59 superimposed on an X-ray image of the femur. The head implant 59 is shown in schematic cross-section.

[0083] The digital template may further include a support overlay. Figure 8 shows an example of a support overlay that includes a first line 60 extending from the central axis of the head implant 59, a second line 61 defining the femoral axis, and an angle 62 between the first line 60 and the second line 61. The angle 62 between these two lines is shown as 143 degrees. The angle 62 is the varus-valgus angle and is sometimes called the stem-shaft axis. The angle 62 is a critical angle for determining the proper position of the digital template (i.e., the surface replacement head implant 59).

[0084] Determining the appropriate position of the digital template 1404C may include receiving user input and rearranging the digital template based on the user input. User input may include click-and-drag operations using a cursor. Determining the appropriate position of the digital template may be facilitated by an assistive overlay on the bone image.

[0085] In this example, using an assistive overlay, the surface replacement head implant axis 60 should be positioned as close to vertical as possible, and therefore the inversion-eversion angle 62 should be greater than at least 130 degrees, preferably in the range of 135 to 145 degrees. Thus, the first line 60 and the second line 61 help determine the correct position of the digital template. Additional assistive overlay features, such as additional lines, may be used.

[0086] Identifying one or more positioning points 1404D may be achieved by receiving user input and generating one or more positioning points based on the user input. Alternatively, one or more positioning points may be identified using an appropriate algorithm.

[0087] In this embodiment, the head guide 1 for aligning the guidewire 59 to the femur 57 identifies a first positioning point, a second positioning point, and a third positioning point. Figure 9 shows a digital X-ray image including the first, second, and third positioning points. The positioning points are added following user input, for example, following a click operation at each position in the image. The first point 63 corresponds to the fixed jaw portion 43 of the lower jaw subassembly 33, the second point 64 corresponds to the movable jaw portion 44 of the lower jaw subassembly 33, and the third point 65 corresponds to the jaw portion 34 of the upper jaw subassembly 32. The first point 63 is located in the recess of the craniocervical junction of the femur. The second point 64 is located as far away from the first point 63 as possible, as close as possible to the lesser trochanter 66, and within the range of the joint capsule (soft tissue) attachment to the lesser trochanter 66. The third point is located in the depression that is the shortest distance across the neck from the first point 63. All three locations can be easily identified on the X-ray planner.

[0088] Identifying one or more positioning parameters based on one or more positioning points 1404E may be achieved automatically, for example, by using an algorithm that extrapolates positioning parameters based on positioning points.

[0089] Identifying one or more positioning parameters based on one or more positioning points 1404E may alternatively be achieved manually by generating a second digital template, aligning the second digital template to one or more positioning points, and identifying one or more positioning parameters based on the positions of one or more positioning points relative to the second digital template.

[0090] In the context of the head guide 1 for aligning the guidewire 59 to the femur 57, the second digital template is a digital template that includes a first scale and a second scale. Figure 10 shows the second digital template 67, which includes a first scale 68, a second scale 69, a first line 70 extending perpendicularly from the first edge of the first scale 68, and a second line 71 extending perpendicularly from the second edge of the second scale 69. The first scale 68 corresponds to the separation between the mandibular segments 43 and 44. The first scale 68 is a millimeter scale 68. The second scale 69 corresponds to the position of the mandibular segment 34. The second scale 69 is a letter scale 69. The second scale 69 is centered on the first line 70.

[0091] Aligning the second digital template 67 to one or more positioning points includes aligning the first scale 68 to the first point 63 and the second point 64. This template can be moved and angle-adjusted independently of the head implant template, which remains in a fixed (planned) position. Figure 11 shows the second digital template 67 superimposed on an X-ray image with the first scale 68 aligned to the first point 63 and the second point 64. The first scale 68 is positioned so that its zero position coincides with the first point 63. This alignment causes the second scale 69 to coincide with the third point 65.

[0092] Therefore, one or more positioning parameters can be determined based on the position of the second digital template 1404E. In particular, the mandibular spacing (i.e., the distance between the first point 63 and the second point 64) can be determined from the first scale 68. As shown in Figure 11, the distance between the first point 63 and the second point 64 is 31 mm. Therefore, the mandibular spacing is 31 mm. The maxillary position is the position of the third point 65 relative to the second scale 69. Therefore, the maxillary position is "C". The swing arm angle is determined as the angle 73 between the second line 71 and the head implant axis 60. Therefore, the swing arm angle is 88 degrees.

[0093] Figure 13 shows that even without a second digital template, manual measurements can be performed within the planning program, and the head guide settings can be derived from them. However, in this case, interpretation of the upper measurement via a lookup table is necessary to determine that 5.1 mm (74) is closest to the position "C" on the character scale. Therefore, the use of a second digital template may be advantageous in terms of the accuracy of the head guide settings.

[0094] Step 1406 of the preoperative planning method 1400 includes adjusting the device based on one or more positioning parameters.

[0095] In the context of the head guide 1 for aligning the guide wire 59 to the femur 57, the lower jaw distance, upper jaw position, and swing arm angle are used to set the head guide 1. In particular, the lower jaw distance can be adjusted until the measuring scale 50 shows 31 mm, the upper jaw position can be adjusted until it shows "C", and the angle of the guide member can be adjusted until the guide member is aligned to 88 degrees on the protractor 15.

[0096] Therefore, when the head guide 1 is clamped to the femoral neck, the gripping position of the jaw closely corresponds to the three points identified on the X-ray planner. When the guidewire 59 is drilled into the femur 57, it needs to closely correspond to the axis 60 of the surface replacement head template as planned. The purpose of the head guide 1 is to center the head axis within the femoral neck and position it at the appropriate varus / valgus angle, precisely according to the X-ray plan.

[0097] In some embodiments, computer processing tasks can be assigned to receiving processors, including, but not limited to, CPUs, GPUs, DSPs, GP-GPUs, quantum processors, and / or processors optimized for artificial intelligence tasks. In such embodiments, the processor is the receiver, and the processing task is the opportunity. In such embodiments, for example, a complex cloud computing infrastructure may receive a large number of tasks of various types that require execution, and a large number of processors may be housed within the cloud computing infrastructure.

[0098] The descriptions provided herein relate to specific embodiments. It should be understood that the descriptions contained herein are provided for the purpose of enabling a person skilled in the art to practice and use any subject matter as defined herein by the subject matter of the claims.

[0099] The subject matter of the claims is not limited to the embodiments and illustrations provided herein, but should be intended to include modifications of those embodiments, including some of the embodiments and combinations of elements of different embodiments, in accordance with the claims. As with engineering and design projects, the development of such embodiments requires numerous embodiment-specific judgments to achieve the developer's specific goals, such as adapting to system and business constraints, and these judgments may vary from embodiment to embodiment. Furthermore, while this type of development work can be complex and time-consuming, it will be understood by those skilled in the art who benefit from this disclosure that it is a routine task of design, fabrication, and manufacturing.

[0100] Various implementations are referenced in detail, examples of which are shown in the accompanying drawings. In the detailed description, many specific details are stated in order to provide a full understanding of the disclosures provided herein. However, the disclosures provided herein can be implemented without these specific details. In other examples, well-known methods, procedures, components, circuits, and networks are not described in detail so as not to unnecessarily obscure the details of the embodiments.

[0101] Furthermore, while this specification may use terms such as "first" and "second" to describe various elements, it should be understood that these elements should not be limited by such terms. These terms are used solely to distinguish one element from another. For example, the first element may be called the second element, and similarly, the second element may be called the first element. The first element and the second element are both elements, but they should not be considered the same element.

[0102] The terms used in the descriptions of the disclosures provided herein are for the purpose of describing specific embodiments and are not intended to limit the disclosures provided herein. As used in the descriptions of the disclosures provided herein and in the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. As used herein, the terms “and / or” refer to and encompass any possible combination of one or more of the enumerated items relating to the description. As used herein, the terms “include,” “contain,” “equip,” and / or “equip” specify the presence of the described features, integers, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof.

[0103] As used herein, the term "if" may be interpreted, depending on the context, as meaning "when," "in response to," "in response to a decision," or "in response to detection." Similarly, the phrases "if determined" or "if (a particular condition or event) is detected" may be interpreted, depending on the context, as meaning "at the time of the decision," "in response to the decision," "at the time of detection of (a particular condition or event)," or "in response to detection of (a particular condition or event)." The terms "up" and "down," "upper part" and "lower part," "upper part" and "downward," "lower side" and "upper side," as well as other similar terms indicating the relative position above or below a given point or element, may be used in connection with some implementations of the various technologies described herein.

[0104] The above relates to various embodiments of the technology described herein, but other further embodiments may be devised in accordance with the disclosure herein, which may be determined by the claims set forth below. While the subject matter is described in language specific to structural features and / or methodological actions, it should be understood that the subject matter as defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are disclosed as exemplary forms for implementing the claims.

Claims

1. A device for aligning a guide wire to a bone, wherein the device is At least one upper jaw portion that can be configured to contact a portion of the bone, At least two lower jaw portions that can be configured to contact different parts of the bone, A guide member that can be configured to align the guide wire with the bone, Equipped with, A device in which the position of at least one of the at least two lower jaw portions and the position of the guide member, and optionally the position of at least one upper jaw portion, are independently adjustable.

2. At least one of the lower jaw portions and at least one of the upper jaw portions are movable with respect to the longitudinal axis of the device. At least one of the upper jaw portions is movable away from at least two of the lower jaw portions or toward at least two of the lower jaw portions. The guide member is angle-adjustable. The apparatus according to claim 1.

3. The apparatus according to claim 1 or claim 2, further comprising a centering element for maintaining the central position of the guide member between at least one upper jaw portion and at least two lower jaw portions.

4. The frame further comprises, A central body for supporting the guide member, A first lateral portion for supporting at least one of the upper jaw portions, A second lateral portion for supporting at least two of the lower jaw portions, Equipped with, The first and second lateral portions are arranged to move parallel to each other so that the upper jaw portion can move relative to at least two of the lower jaw portions. The apparatus according to claim 2 or claim 3.

5. The apparatus according to claim 4, wherein the guide member is rotatably connected to the central body.

6. The apparatus according to claim 5, wherein the pivot point of the guide member is projected onto a virtual position, and the virtual position is located on the central axis of the central body.

7. The apparatus according to any one of claims 4 to 6, wherein the translation is provided by displacement means arranged to move the first side and the second side relative to each other.

8. The apparatus according to claim 7, wherein the displacement means comprises a scissor clamp mechanism connecting the central body to the first side and the second side.

9. The apparatus according to claim 7, wherein the displacement means comprises a gear, and the displacement means comprises a gear arrangement having a circular gear that engages with a first linear gear and a second linear gear, the circular gear being connected to the central body, the first linear gear being connected to the first side, and the second linear gear being connected to the second side.

10. The apparatus according to any one of claims 4 to 9, wherein at least one of the upper jaw portions is slidably connected to the frame so that the upper jaw portion can move along the longitudinal axis of the frame.

11. The apparatus according to any one of claims 4 to 10, wherein at least one of the upper jaw portions is connected to the frame via a first connecting means, and at least two of the lower jaw portions are connected to the frame via a second connecting means, the first connecting means and the second connecting means are not interchangeable.

12. At least two of the aforementioned lower jaw portions are Fixed jaw portion, Movable jaw and, Equipped with, The apparatus according to any one of claims 1 to 11, wherein the movable jaw portion is slidably connected to the fixed jaw portion so that the movable jaw portion can move relative to the fixed jaw portion.

13. The apparatus according to any one of claims 1 to 12, further comprising a displacement gauge for determining the position of the upper jaw portion, and / or a separation gauge for measuring the distance between at least two of the lower jaw portions.

14. The apparatus according to any one of claims 1 to 13, further comprising an angle gauge for measuring the angle of the guide member with respect to the longitudinal axis of the apparatus.

15. The apparatus according to any one of claims 1 to 14, further comprising a locking means for preventing the jaw portion from moving away from the longitudinal axis of the apparatus.

16. The apparatus according to any one of claims 1 to 15, wherein at least one of the upper jaw portions and at least two of the lower jaw portions are shaped to at least partially conform to the shape of the bone.

17. A preoperative planning method for setting up a device for aligning a guidewire with bone, wherein the processing method is: The steps include accessing image data of the bone, A step of identifying one or more positioning parameters based on the image data, A step of adjusting the device based on one or more positioning parameters, A method for processing preoperative plans, including the following:

18. Identifying one or more of the positioning parameters is Generating digital templates, The digital template is superimposed onto the image of the bone, Determining the appropriate position of the aforementioned digital template, Identifying one or more positioning points, Identifying one or more positioning parameters based on one or more positioning points, A method for processing preoperative planning according to claim 17, including the method described in claim 17.

19. The method for processing a preoperative plan according to claim 18, wherein the digital template includes a support overlay.

20. Identifying one or more positioning parameters based on one or more positioning points is, To generate a second digital template, Aligning the second digital template with respect to one or more of the positioning points, Identifying one or more positioning parameters based on the positions of one or more positioning points relative to the second digital template, A method for processing preoperative planning according to claim 18 or claim 19, including the method described in claim 18 or claim 19.

21. The preoperative planning method according to any one of claims 17 to 20, wherein the apparatus is the apparatus according to any one of claims 1 to 16.

22. One or more of the positioning parameters are The distance between the lower jaw and, The position of the upper jaw, The angle of the guide member and A method for processing preoperative planning according to claim 21, including the method described in claim 21.

Images