Surgical guiding devices

Abstract

The present invention relates to a surgical guidance device for assisting osteotomy, comprising a guidance device body, an incision slot, a plurality of openings, and a guidance element positioned at a predetermined location relative to a feature portion or part of the bone located in the patient's bone, thereby assisting in the precise positioning of the surgical guidance device during use. The present invention also relates to a surgical system comprising a surgical guidance device and a preliminary guidance element comprising a guidance device body and a conduit for positioning a rod or wire in the bone. The present invention also discloses a method for manufacturing a surgical guidance device, comprising the steps of performing a preoperative analysis and fabricating a surgical guidance device using the output thereof.

Description

Technical Field

[0001] Technical Field The present disclosure relates to the field of surgical guidance devices used when performing surgeries such as osteotomy.

Background Art

[0002] Background Art It should be understood that even if any prior art is referred to herein, such reference does not admit that the prior art constitutes a part of the common general knowledge in this technical field, in Australia or other countries.

[0003] Osteoarthritis is a condition in which pain occurs due to displacement of bones in the knee region (e.g., the femur and tibia). Open-wedge osteotomy is a procedure used for the treatment of osteoarthritis. In this procedure, the surgeon makes an incision in the patient's tibia or femur, inserts a wedge to open the incision, thereby adjusting the overall alignment of the tibia (or vice versa) with respect to the femur. When the desired correction angle is obtained, the position of the tibia (or femur) is fixed using a bone-cutting plate firmly fixed to the bone portions on both sides of the wedge, and a bone graft material is inserted into the open wedge-shaped portion to enable regeneration of the bone graft material. Conversely, the surgeon can also excise the bone in a wedge shape, thereby adjusting the overall alignment of the tibia (or vice versa) with respect to the femur. There are various types of osteotomies that can be performed. Among them, high tibial osteotomy (HTO) and distal femoral osteotomy (DFO) are treated on the tibia and femur, respectively.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The success of osteotomy largely depends on the surgeon's ability to adhere to the preoperative plan. However, this also means that the procedure is heavily dependent on the surgeon's skill and execution. Therefore, there is a risk that the patient will not achieve the desired outcome due to surgical negligence. For this reason, there is a need for devices that help surgeons perform open wedge osteotomy and minimize the risks associated with the procedure. [Means for solving the problem]

[0005] overview In a first aspect, a surgical guidance device for assisting osteotomy is disclosed, comprising: a guidance device body, the guidance device body being molded and configured to be positioned relative to the bone of a patient, the guidance device body having proximal and distal components comprising the guidance device body; an incision slot extending through the guidance device body, positioned to guide an incision into the bone of a patient; a plurality of openings extending through the guidance device body for assisting the positioning of an implantable element and / or guiding a drilling into the bone of a patient, at least one of which is a conduit extending through the guidance device body adjacent to the incision slot, the conduit being adapted to guide the insertion of a rod or wire into the bone of a patient; and a guidance element configured to be positioned in a predetermined location relative to a feature located in the bone of a patient, or a feature forming a portion of the bone of a patient, thereby assisting the correct positioning of the surgical guidance device relative to the bone of a patient during use. Such devices can help surgeons perform open wedge osteotomies accurately. More specifically, such devices can help surgeons identify the locations that need to be surgically accessed / operated.

[0006] In some forms, the device is individually fabricated to suit the anatomical structure of the specific patient who will use it. This has the advantage of incorporating the patient's unique details and the surgeon's specific clinical practice into the guidance device, and then manufacturing the guidance device. This limits the need to modify the guidance device during surgery and enables a product tailored to benefit a specific patient. The device is manufactured using additive manufacturing methods, which makes it possible to produce affordable, personalized products.

[0007] In some embodiments, the conduit may extend through the proximal component of the guidance device body at a position proximal to the incision slot and is adapted to guide the insertion of a rod or wire into the patient's bone.

[0008] In some embodiments, the conduit may extend through the distal component of the guidance device body at a position distal to the incision slot.

[0009] In some embodiments, the guide element includes a guide slot extending proximal from the distal edge of the distal component, the size and position of which the guide slot is determined to be located around a rod or wire pre-inserted into the patient's bone.

[0010] In some embodiments, the guide element is positioned in accordance with a desired anatomical landmark on the patient's bone, thereby positioning the surgical guide device at the desired location on the patient's bone.

[0011] In some embodiments, the guide element may be provided as a detachable component that is fixed to a surgical guidance device when in use.

[0012] In some embodiments, the proximal and distal components may be detachably engaged with each other.

[0013] In some embodiments, the incision slot may be located midway between the proximal and distal components.

[0014] In some embodiments, the conduit may be tubular.

[0015] In some embodiments, the guide element may be formed as part of a surgical guidance device. This reduces the number of individual components that are handled during the surgical procedure.

[0016] In some embodiments, the guide element may be formed on a proximal component of a surgical guidance device.

[0017] In some embodiments, the guide element may include a recess or groove that corresponds to a feature of an anatomical landmark.

[0018] In some embodiments, the recess or groove may be provided with an indicator.

[0019] In some embodiments, the indicator may be formed from a K-wire or a fastening wire.

[0020] In some embodiments, the indicator may be manufactured from a radiopaque material.

[0021] In some embodiments, the anatomical landmark may include a portion of the articular surface between two bones in the patient.

[0022] In some embodiments, the articular surface may include the femoral condyle.

[0023] In a second aspect, a surgical guidance device for assisting osteotomy is disclosed, comprising: a guidance device body, the guidance device body being molded and configured to be positioned relative to the bone of a patient, the guidance device body having a proximal component and a distal component comprising the guidance device body; an incision slot extending through the guidance device body and positioned to guide an incision into the bone of a patient; and a plurality of openings extending through the guidance device body for assisting the positioning of an implantable element and / or guiding a drilling into the bone of a patient, at least one of which is a conduit extending through the proximal component of the guidance device body at a position proximal to the incision slot and fitted with a conduit to guide the insertion of a rod or wire into the bone of a patient, at least one of which is a guidance slot extending proximal from the distal edge of the distal component, the guidance slot being sized and positioned to be located around a rod or wire pre-inserted into the bone of a patient.

[0024] In a third aspect, there is disclosed a surgical guidance device for assisting osteotomy, the surgical guidance device comprising a guidance device body shaped and configured to be positioned relative to a patient's bone, the guidance device body having a proximal component and a distal component that make up the guidance device body; an incision slot extending through the guidance device body and positioned to guide an incision into the patient's bone; a plurality of apertures extending through the guidance device body to assist in positioning implantable elements and / or guiding perforations into the patient's bone, at least one of the plurality of apertures being a conduit extending through the proximal component of the guidance device body at a position proximal to the incision slot and adapted to guide the insertion of a rod or wire into the patient's bone; and a guiding element positioned corresponding to a desired anatomical landmark of the patient's bone, whereby the surgical guidance device is positioned at a desired location on the patient's bone. <> <>

[0025] <> In a fourth aspect, there is disclosed a surgical guidance system comprising the above-described surgical guidance device and a preliminary guidance element comprising a preliminary guidance device body shaped and configured to be positioned relative to a patient's bone and a conduit for positioning a rod or wire. This system may have the advantage of not only enabling accurate positioning of elements essential for surgery but also allowing for high visibility and a simple step-by-step process. <> <>

[0026] <> In a fifth aspect, there is provided a method of manufacturing the above-described surgical guidance device for assisting osteotomy of a patient's bone, the method comprising: performing at least one preoperative step on the patient to determine the preoperative state of the bone; and using the output obtained as a result of the preoperative step to fabricate the surgical guidance device, the surgical guidance device having a shape and configuration suitable for performing osteotomy on the patient's bone.

[0027] In some embodiments, the preoperative step may include one or more of radiography, computed tomography, and magnetic resonance imaging (MRI).

[0028] In some forms, there is provided a surgical guidance device for assisting osteotomy, the surgical guidance device comprising: a guidance device body shaped and configured to be positioned relative to the patient's bone, the guidance device body having a proximal component and a distal component that make up the guidance device body; an incision slot extending through the guidance device body and positioned to guide an incision into the patient's bone; and a plurality of apertures extending through the guidance device body for assisting in positioning an implantable element and / or guiding a perforation into the patient's bone, at least one of the plurality of apertures being a conduit extending through the proximal component of the guidance device body at a position proximal to the incision slot and adapted to guide the insertion of a rod or wire into the patient's bone, the plurality of apertures including an induction slot extending proximally from the distal edge of the distal component, the induction slot being sized and positioned to be located around a rod or wire already inserted into the patient's bone.

[0029] Embodiments will now be described, by way of example only, with reference to the accompanying drawings.

Brief Description of the Drawings

[0030] [Figure 1] This is a schematic diagram showing a surgical guidance device according to one embodiment of the present disclosure in contact with bone. [Figure 2] Figure 1 is an enlarged view of the surgical guidance device. [Figure 3A] This is a top view showing a surgical guidance device according to a second embodiment of the present disclosure in contact with bone. [Figure 3B] This is a front view showing a surgical guidance device according to a second embodiment of the present disclosure in contact with bone. [Figure 4A] This is a front view of the guide element according to various embodiments of the present disclosure. [Figure 4B] This is a front view of the guide element according to various embodiments of the present disclosure. [Figure 4C] This is a front view of a surgical guidance device using one embodiment of a guidance element. [Figure 5A] Figure 4C is a side view showing the surgical guidance device in contact with the bone. [Figure 5B] Figure 4C is a front view showing the surgical guidance device in contact with the bone. [Figure 6A] A side view of a surgical guidance device in which a second embodiment of the guidance element is partially attached to bone. [Figure 6B] A side view of a surgical guidance device in which a second embodiment of the guidance element is partially attached to bone. [Figure 6C] This is a perspective view of a surgical guidance device in which a second embodiment of the guidance element is partially attached to bone. [Figure 7A] This is a rear view of a surgical guidance device equipped with one embodiment of a guidance element. [Figure 7B] This is a side view showing a surgical guidance device equipped with one embodiment of a guidance element in contact with bone. [Figure 8] This is a front view showing a surgical guidance device according to one embodiment of the present disclosure in contact with bone. [Figure 9]This is a side view showing the usage state of a surgical guidance device according to one embodiment. [Figure 10] This is a schematic diagram of a preliminary induction element according to one embodiment of the present disclosure. [Figure 11] This is a schematic diagram of the steps in using a surgical guidance device comprising the preliminary guidance element shown in Figure 10 and the surgical guidance device shown in Figure 1. [Modes for carrying out the invention]

[0031] Detailed explanation The following detailed description refers to the accompanying drawings, which form part of the detailed description. Exemplary embodiments described in the detailed description, shown in the drawings, and defined in the claims are not limiting to the invention. Other embodiments may be utilized and other modifications made without departing from the spirit or scope of the presented subject matter. It will be readily apparent that the aspects of this disclosure described herein and shown in the drawings can be arranged, substituted, combined, separated, and designed in a wide variety of configurations, all of which are envisioned in this disclosure.

[0032] Referring to Figure 1, the disclosed object is a surgical guidance device 10 for assisting surgical procedures such as osteotomy. The surgical guidance device 10 comprises a guidance device body 12 configured to be positioned and fixed to the patient's bone 14. In the embodiments shown in Figures 1, 2, 10, and 12, the bone is the tibia. However, the surgical guidance device 10 may be used on other bones, such as the femur, to perform procedures on the femur. This is best illustrated in Figures 8 and 9.

[0033] For use, the surgical guidance device is positioned relative to the bone during surgery. Once positioned relative to the bone, the guidance device is fixed by a process such as drilling, incision, or other fixation procedure. In this case, the surgical guidance device 10 is configured to assist the surgeon performing the procedure in accurately identifying the position on the bone 14. These positions may include positions for incisions, positions for inserting implantable elements, or positions where holes need to be drilled or can be drilled.

[0034] The surgical guidance device 10 can be tailored to a specific patient. Each patient has a different anatomical structure, including bone size and shape. Therefore, it is preferable that a different surgical guidance device be used for each individual patient. In this regard, preoperative examinations are performed on the patient to obtain measurements, and these measurements are used to design and configure the surgical guidance device 10 for use in the patient's osteotomy. Preoperative examinations may include imaging or measurements such as radiography, computed tomography (CT), and magnetic resonance imaging (MRI). Imaging or measurements of the knee region, bone, and / or the entire lower limb may determine existing parameters of bone and limb integrity, such as the required corrective angle between the femur and tibia. Dynamic preoperative examinations, such as gait analysis, may be used to determine kinematic integrity and / or inverse dynamics for determining joint forces and moments in the patient's anatomical structure, and / or joint pressure in focal joints such as the knee joint.

[0035] Surgical guidance devices may be designed based on the output of preoperative scanning, measurement, and evaluation. In some forms, the relevant medical professionals evaluate the output of scanning and measurement and provide input regarding the shape, size, and configuration of the surgical guidance device. For example, a clinician may evaluate the measurement data, thereby providing the desired corrective alignment. This then allows for the fabrication of the surgical guidance device as needed, and optimization of the device's mechanism, such as the position of the incision slot or the angle of the perforation, based on anatomical structure or desired clinical outcome. The device is then manufactured based on the output and evaluation and comments from the medical team.

[0036] By using a surgical guidance device specially designed based on measurements taken on the patient, surgeons can minimize the possibility of errors in identifying the locations where cuttings and incisions need to be made, and where holes need to be drilled to accommodate implantable elements. The surgical guidance device 10 also helps to reduce the time required to perform surgery because it allows surgeons to quickly identify the locations where various procedures need to be performed.

[0037] As described above, the surgical guidance device 10 comprises a guidance device body 12, which is configured to contact the bone 14 at the location where the surgery is to be performed. More specifically, the guidance device body 12 may be configured to extend across the incision to be made in the bone 14. In other words, the guidance device body 12 can be used to identify specific sites located on both sides of the incision to be made in the bone 14. As described above, the optimal position of the guidance device body 12 can be determined during the preoperative planning stage, which allows the surgeon to optimally position the incision and the specific site for the surgery.

[0038] The guide device body 12 comprises a planar or substantially planar structure having a bone contact surface 20 and an opposing surface 22. In some embodiments, this planar structure is shaped to match and align with the external shape of the bone. The bone contact surface 20 allows the guide device body 12 to contact the bone 14 and is shaped to contact the bone over most of the bone contact surface. In some embodiments, the guide device body 12 allows for initial engagement with the bone sufficient for the initial positioning of the surgical guide device 10. The opposing surface 22 is oriented away from the bone during use.

[0039] Bones (such as the tibia or femur) have contoured surfaces. Therefore, the guide device body 12 must be able to match the surface of the bone 14, thereby ensuring optimal positioning of the surgical guide device 10. To facilitate this, the guide device body 12 may be manufactured from a material that can be molded to engage with bone, or from a malleable or flexible material. For example, the guide device body 12 may be made of polyamide (nylon), PEEK, or titanium / titanium alloy, or other metals, plastics, or alternative materials that can be molded to manufacture surgical devices. Surgical guide devices may also be manufactured using techniques such as 3D printing, which allows for the rapid fabrication of parts in a reliable manner.

[0040] Generally, the shape and size of the guidance device body 12 may be determined according to parameters such as the length of the incision made, the number and size of the implantable elements used, the spacing between these implantable elements, and the type, shape, and size of the bone. As mentioned above, these parameters may be determined from preoperative examinations.

[0041] The guide device body 12 consists of a proximal component 16 and a distal component 18. In the illustrated embodiment, the proximal and distal components include a plurality of openings (26, 26a) and (28, 28a) that extend through the body. The openings are positioned in a predetermined location that helps the surgeon position an implantable element into the patient's bone 14 and / or guide the perforation. The openings may include cavities, holes, slots, or tubes, or any other openings that allow for the positioning of an implantable element and, typically, perforation through the guide device body.

[0042] In some configurations, the proximal and distal components may be joined or connected to each other during use, thereby forming the induction device body 12. Such connection / joining can be facilitated by using any mounting means such as engaging mats, adhesives, connecting elements, screws, or other suitable mechanisms. Alternatively, the proximal component 16 and the distal component 18 may be integrally formed (i.e., formed from a single piece of solid material constituting the induction device body 12).

[0043] In the illustrated embodiment, the proximal component 16 comprises a head portion 36 and a leg portion 38. The head portion 36 is generally circular or semicircular and is located near the articular surface 32 of the bone. The head portion 36 facilitates the fixation of the proximal component to the bone portion on one side of the incision. The leg portion 38 extends longitudinally from the head portion 36 along the bone 14, thereby facilitating the connection between the proximal and distal components. For example, the leg portion may have grooves, other contour elements, or other shape elements, as best shown in Figure 10, and the leg portion may be configured to accommodate projections or other shape elements located on the distal component. In the illustrated embodiment, the head portion 36 is located on one side of the incision made in the bone, and the leg portion 38 extends to the other side of the incision. Naturally, the head portion and leg portion may be of any desired shape and size, provided that the surgical guidance device 10 can perform its intended function.

[0044] In the illustrated embodiment, the head portion 36 has a semicircular cross-sectional shape (as shown in Figures 1-3 and 4c) and has three openings 26a that extend through the head portion from an outward-facing surface to an inward-facing surface. In the illustrated embodiment, the openings may be aligned with each other across the generally proximal end of the head. In some embodiments, the head may have a positioning extension. In other embodiments, the head portion may be configured to have other shapes, such as generally square, rectangular, or similar to / matching the surface of the bone it contacts. For example, as best shown in Figure 7a, the head portion 36 may match the surface of the bone 14 it contacts (see Figure 7b for an assembled guide device showing the head portion 36).

[0045] In the illustrated embodiment, the leg portion 38 includes an elongated hook-shaped portion extending distally from the head portion. The elongated hook-shaped portion can be connected in a hook-like manner, by wrapping around, or otherwise by engaging with a complementary mechanism located on the distal part 18. The elongated hook-shaped portion may be positioned to extend from one side of the distal end of the head portion and may extend over most or half of the head portion.

[0046] The distal component 18 comprises a main body portion 40, which is coupled to the proximal component 16, thereby forming the guide device body 12. The main body portion 40 extends longitudinally along the bone (i.e., extends similarly to the leg portion 38 of the proximal component 16). The main body portion 40 may also be provided with a tab / projection (best shown in Figure 10), which may be housed in a groove present in the leg portion 38 of the proximal component 16.

[0047] As described above, the proximal and distal components are provided with multiple openings (26, 26a) and (28, 28a) that extend through the guidance device body 12, thereby assisting in positioning the implantable elements into the patient's bone and / or guiding the perforation. The openings connect the bone contact surface 20 and the opposing surface 22, thus allowing the surgeon to insert a wire / rod / tool ​​to contact the bone 14.

[0048] In the illustrated embodiment, the head portion 36 of the proximal component 16 comprises three openings 26 (best shown in Figure 2) and a conduit 26a. The linearly arranged openings 26 are configured to accommodate implantable elements such as screws, which facilitate the connection between two portions of bone formed after the incision has been made. The openings facilitate drilling for accommodating such screws / implantable elements. It is clear that the size, shape, number, and position of such openings may be modified according to requirements. For example, patients with a large bone surface area may require the use of four openings. Similarly, patients with a small bone surface area may require only two openings. The openings do not necessarily have to be arranged linearly.

[0049] The conduit 26a is located proximal to the incision slot 30 (described further later). The conduit 26a is configured to guide a rod, plate, or wire to be implanted in the bone. The position of the conduit 26a is such that the inserted rod / wire is approximately parallel to the plane of the incision slot 30. As a result, the wire / rod acts as a guide device for the surgeon making the incision in the bone. For example, the surgeon can move the blade in such a manner that the gap between the blade and the wire / rod is kept constant. This ensures that the incision is made along the desired plane of the bone. The conduit is angled with respect to the plane of the guide device body 12. The angle may range from 10 to 60° in any orientation (e.g., one or a combination of the coronal, sagittal, or transverse planes), and the angle depends on the position of the tibial tuberosity and / or fibular head or fibular styloid process, and / or the height of the metaphysis of the tibia.

[0050] The distal component 18 has openings in the shape of a slot 28 and a conduit 28a. Similar to the openings located in the proximal component 16, these openings connect the bone contact surface 20 to the opposing surface 22 of the guide device body 12. The slot 28 extends proximal from the distal edge 42 of the distal component 18 (best shown in Figure 2) into the interior of the distal component. The slot 28 is sized to accommodate an implantable wire / rod 44 pre-implanted in the bone 14 and extends to or beyond the position where the pre-implanted wire / rod would be located. For example, the surgeon can insert the wire 44 before the proximal and distal components are placed in the bone 14. The dimensions and angles of the slot 28 relative to the longitudinal axis Z of the bone 14 may be determined from preoperative planning and examination.

[0051] The slot 28 also facilitates the correct positioning of the surgical guidance device 10 during use. The surgeon can use this slot to correctly position the distal portion of the surgical guidance device against the bone. The slot may include markings or steps, which further aid in correct positioning.

[0052] The conduit 28a can be used to guide a surgeon to perforate the bone 14. Subsequently, an implantable element such as a screw / wire / rod may be implanted in the perforation. The conduit 28a connects the bone contact surface 20 to the opposing surface 22. In the illustrated embodiment, two conduits are present in the main body portion 40. However, it is clear that the size, number, shape, and position of the conduits may be modified.

[0053] Generally, the conduits 26a and 28a are tubular and project outward from the opposing surface 22. However, it should be understood that the conduits can also take other shapes, such as including a square cross-section.

[0054] The proximal and distal components may also include extensions 24a and 24b extending from the proximal and distal components. The extensions are configured to extend laterally around the bone, increasing the contact area between the guide device body 12 and the bone 14, thereby improving the engagement or contact of the surgical guide device 10. The extensions 24a and 24b may be integrated with the guide device and may be made of the same material as the guide device body 12 or other suitable material. The extensions 24a and 24b can wrap around the uneven / contoured surface of the bone, thereby improving the grip of the guide device body 12 when it is positioned against the bone surface.

[0055] The surgical guidance device 10 also includes an incision slot 30, which extends through the guidance device body 12 and is positioned to guide an incision into the patient's bone 14. The incision slot 30 extends through the guidance device body, thereby connecting the bone contact surface 20 and the opposing surface 22 of the guidance device body 12. By inserting an incision blade into the incision slot 30, the surgeon can access a specific location in the bone 14 where an incision should be made. In the illustrated embodiment, the incision slot 30 is integrated with the proximal component 16. However, it will be apparent to those skilled in the art that the incision slot 30 may also be integrated with the distal component. Alternatively, the incision slot 30 may be provided as a separate component that can be coupled / connected to both the proximal and distal components.

[0056] The incision slot 30 may be positioned at a predetermined angle with respect to the horizontal axis X of the bone (as shown in Figures 1 and 2). The inclination angle of the incision slot 30 may be determined from measurements taken during the preoperative examination phase and is generally dependent on the anatomical structure of the knee and the desired correction. In the illustrated embodiment (as best shown in Figure 2), the incision slot 30 extends to a protrusion 33 projecting from the opposing surface 22 of the guide device body 12. The protrusion 33 facilitates clear identification of the incision slot 30 and prevents / minimizes interaction between the blade and other mechanisms of the surgical guide device 10 when inserting the blade into the incision slot. In the illustrated embodiment, the incision slot 30 extends from the lateral edge of the protrusion 33 over most of the length of the protrusion 33 and is separated by the lateral edge of the protrusion 33 from the opposite edge. The surfaces 34a and 34b of the raised portion 33, perpendicular to the lateral edge of the raised portion 33, define the upper surface of the incision slot 30, which is visible to the surgeon. The lower surface of the incision slot (i.e., the surface facing the bone) may be coplanar with the bone contact surface 20 of the guide device body 12.

[0057] The surgical guidance device 10 includes at least one guidance element 13, the at least one guidance element 13 configured to be positioned in a predetermined location relative to a corresponding feature that is located in or forms part of the patient's bone 14. Essentially, this feature acts as a reference point in the bone, which the surgeon can use to position the guidance device 10, thereby enabling surgical incisions / procedures to be performed at the desired location in the bone. The guidance element functions to provide a visual indicator when positioning the guidance device 10 in this manner relative to the bone 14. For example, if the surface of the guidance element aligns with / is located at the desired proximal position to a feature in the bone (e.g., the surface of one end of the bone, or a previously inserted wire / rod / pin), the surgeon can visually confirm that the guidance device 10 is positioned correctly to begin the subsequent steps. By locating the feature in the bone and positioning the guidance element appropriately, the surgeon can minimize the time required to correctly position the guidance device 10. The guidance element also prevents careless errors in the placement of the guidance device 10. For example, if the guide element is not properly aligned with the desired feature of the bone, and thereby the desired visual indicator is not provided, the surgeon can make further adjustments to the guide device 10 and then proceed to the next step of the procedure.

[0058] The guiding element may take various forms, as long as it performs its intended function. In its simplest form, the guiding element may be a projection extending from the surgical guidance device 10. In this case, the surgeon only needs to ensure that the surface of the projection is aligned with / at the same height as the characteristic part of the bone.

[0059] In some configurations, the guide element is in the form of a guide slot (slot 28 as described above), which is located around a rod or wire that has been pre-inserted into the bone 14.

[0060] In other forms, the guide element 13 / 113 is in the form of a wire / pin, which is positioned at or near a desired anatomical landmark 15 / 115 (see Figures 3 and 8) on the bone surface. In some forms, the anatomical landmark includes a portion of the articular surface between two bones of the patient. For example, the femoral condyle 117 located at the end of the femur (best shown in Figure 9) can be used as an anatomical landmark for positioning the surgical guide device 10 using the guide element 13. Similarly, the tibial plateau located at the end of the tibia can also be used as an anatomical landmark for positioning the surgical guide device 10 for procedures performed on the tibia. In the case of the femoral condyle, it can also be seen that the surface of the guide element 113 is at the same level as the surface of the femoral condyle. Similarly, the surface of element 13 is at the same level as the tibial plateau 15. Therefore, in either case, the guide elements 13 / 113 allow the guide device 10 to be positioned at a certain distance from the end of the bone 14, thereby ensuring that surgical procedures such as drilling and incision are performed only on the bone and no other areas are damaged.

[0061] It will be obvious to those skilled in the art that multiple guiding elements may be provided on the guiding device 10. Each guiding element may be positioned at a different location on the guiding device corresponding to a different feature. For example, one or more guiding elements may be positioned to correspond to the cartilage, meniscus, ligaments, etc., of the knee joint. This makes it possible to position the guiding device 10 based on multiple feature of the bone 14, and therefore improves the accuracy of positioning.

[0062] The dimensions, shape, size, and properties of the guiding elements used, their position in the guiding device 10, and the corresponding reference features may all be determined from the preoperative planning stage.

[0063] In some embodiments, the guide element may be provided as a detachable component that is fixed to the surgical guide device 10 when in use. As best shown in Figures 4a to 4c, the (previously) guide element 13 is provided as a separate component that can be fixed to the proximal component 16.

[0064] In the embodiments shown in Figures 4A to 4C, the guide element 13 enables the positioning of the surgical guide device relative to anatomical landmarks. This form of guide element comprises a mountable guide element body, which is configured to be fixed to the surgical guide device when in use. The guide element 13 comprises a positioning slot for a guide pin or guide wire 17 and a mounting portion configured to be placed on and inserted into the upper part of the head portion 36 of the proximal portion 16 of the surgical guide device. The guide pin or guide wire 17 may be in the form of a pin requiring a straight recess or a fixed recess, as shown in Figure 4a, or in the form of a flexible wire requiring a curved slot, as shown in Figure 4B.

[0065] In the embodiments shown in Figures 5A and 5B, the guide element 13 contains the wire 17 in the recess 13a and is fixed to the proximal portion of the surgical device. The guide element 13 is sized and shaped such that the conduit and proximal portion along which the incision slot is routed are visible and accessible during use.

[0066] In the embodiments shown in Figures 6A to 6C, the guide element 13 includes a curved recess 13a and can be fixed to the proximal portion of the surgical guidance device.

[0067] Referring to Figures 7A and 7B, the guide element 13 includes a recess 13a for a guide. The surgical guide device 12 has a proximal portion 16 which is configured to engage with the guide element 13 by surface engagement, thereby allowing the guide element to be used in conjunction with the surgical guide device.

[0068] In other embodiments, the guide element may be formed as part of the surgical guidance device 10. For example, a guide element in the form of a guide slot 28 is formed as an integral part of the distal component 18 of the guidance device body 12.

[0069] In some embodiments, the guide element 13 may be formed as part of the proximal component 16 of the surgical guide device 10. For example, the guide element 13 may be integrated with the proximal component 16 during manufacturing. Alternatively, the guide element 13 may be manufactured separately and permanently or semi-permanently fixed to the proximal component 16 of the surgical guide device 10 using appropriate fastening means.

[0070] In some embodiments, the guide element includes a recess or groove 13a / 113a (best shown in Figures 3 to 6C, 7B, and 8), the recess or groove 13a / 113a corresponding to a feature of an anatomical landmark.

[0071] For example, as best shown in Figure 8, the recess or groove 113a is fabricated so that the recess or groove 113a follows the contour of the femoral condyle. To position the guide device 10, the guide device 10 may be moved up and down so that the groove 113a of the guide element 113 aligns with the contour of the femoral condyle 115.

[0072] Similarly, the guide device 10 may also be moved so that the groove 13a of element 13 aligns with the tibial plateau 15 shown in Figure 3.

[0073] These recesses or grooves may further be configured to accommodate indicators 17 such as wires / rods / pins. The indicators can serve to improve visibility by highlighting their contrast with other parts of the surgical guide device 10. This can be particularly useful in situations where the view is obstructed by blood or other debris and clear indicators of position are not clearly visible. The wires / rods / pins may be selected from various types of surgical-grade materials. For example, K-wires (rigid) or fastening wires (flexible) may be located in the recesses / grooves. As best shown in Figures 4a and 5b, K-wires located in the recesses / grooves are clearly visible against the background of the guide element 13. The dimensions of the grooves may be configured so that the wires / rods / pins snap into the recesses / grooves, so that the wires / rods / pins do not come out of the recesses / grooves when the surgeon attempts to position the guide device 10.

[0074] In some embodiments, the material selected for the wire / rod / pin may be radiopaque, which allows for clear identification in various images (e.g., X-rays). This allows surgeons to more clearly confirm positioning during surgical procedures by using such techniques.

[0075] As best illustrated in Figure 9, in some embodiments, the surgical guidance device 10 of the embodiments of the present disclosure is used to perforate the femur by positioning the conduit in the femur such that the conduit crosses the apex of the femoral condyle 117. Furthermore, the conduit 118 may be fabricated (through multiple openings located in the surgical guidance device) so as to allow insertion of screws or other components necessary for the surgical procedure.

[0076] Surgical System In another embodiment, a surgical guidance system 100 is disclosed comprising the surgical guidance device 10 described above and a preliminary guidance element 102. The preliminary guidance element comprises a preliminary guidance device body 104 molded and configured to be positioned relative to the patient's bone 14, and a conduit 106 for positioning a rod or wire 44. In the illustrated embodiment, the preliminary guidance element comprises a preliminary guidance device body 104 in the form of a planar or substantially planar contact portion configured to be positioned relative to the bone. The preliminary guidance element 102 may be manufactured from the same material as the guidance device body 12 described above, thus enabling optimal fitting of the element to the bone 14.

[0077] The preliminary guidance element 102 includes a preliminary guidance conduit 106 that extends through the preliminary guidance device body. The preliminary guidance conduit 106 may be located at any position on the preliminary guidance device body, but in the illustrated embodiment, it is located distal to the preliminary guidance device body. The preliminary guidance conduit facilitates the placement of the wire / rod into the bone. The conduit 106 facilitates the surgeon to perforate the bone 14 at a desired location and angle. Subsequently, an implantable element such as a wire / rod 44 may be inserted into the bone 14. Such placement of the wire / rod 44 may have multiple applications. In the illustrated embodiment, the wire / rod 44 placed using the conduit 106 functions as an incision stopper for the incision blade that makes an incision in the bone. Thus, the surgeon can stop the incision procedure the moment the blade contacts the wire / rod 44. This has the advantage of preventing undesirable damage to the bone structure during the incision procedure. By changing the angle of the conduit 106, the wire / rod 44 can be inserted at various angles, and the limit of the incision depth can be changed accordingly. The angle and incision depth may be determined by preoperative planning and preoperative examination.

[0078] The auxiliary guide element 102 may include extensions 108a and 108b extending from the guide device body 104. As described above regarding the extensions 24a and 24b, these extensions can further improve contact between the guide element 102 and the bone 14.

[0079] In some embodiments, the guide element may be provided as part of a preliminary guide element 102. For example, the guide element described above may be formed on the preliminary guide element 102 instead of / in addition to the guide element formed on the proximal / distal component.

[0080] Both the surgical guidance device 10 and the preliminary guidance element 102 can be fabricated using well-known techniques such as 3D printing. Other techniques such as injection molding or milling may also be used if it is necessary to mass-produce specific parts.

[0081] Surgical systems may include additional elements to assist in the performance of procedures.

[0082] Surgical devices used during surgical procedures The use of the surgical system 100 will be described with reference to Figures 10 and 11. Prior to surgery, the surgeon performs an examination to determine the preoperative condition of the knee. This may be done using various techniques as described above.

[0083] Data obtained from preoperative examinations are input into a computer program capable of calculating the required amount of correction for key bone parameters. The output may be displayed as a series of images of the surgical device 10. For example, the computer program can generate a 3D image of the surgical device 10. Then, using such a 3D image, the surgical guidance device 10 and preliminary guidance elements 102 may be fabricated using techniques such as 3D printing. By using the computer program, it is also possible to incorporate any changes that the surgeon deems necessary for the configuration of the device.

[0084] Once the patient's knee has been examined for the procedure and is ready, the surgeon begins the placement of the preliminary guide element 102. Following the preoperative plan, the guide element 102 is positioned in a specific area of ​​the bone 14, and perforation is initiated through the tubular conduit 104. Subsequently, a wire / rod 44 (e.g., a restraint wire) may be inserted into the conduit 104. This completes step I of the procedure, as shown in Figure 11.

[0085] In step II, the preliminary guide element 102 is removed, which allows the wire / rod 44 to be held in place in the bone.

[0086] Next, the surgeon positions the proximal component 16 and the distal component 18 together so that the slot 28 accommodates the wire / rod 44 that has been previously inserted into the bone. The proximal and distal components may be joined together, and then the slot is positioned in the bone to accommodate the rod 44. Subsequently, both components are fixed to the bone 14 using implantable elements.

[0087] Once the proximal and distal components are positioned in the bone, a second wire / rod is inserted into the tubular conduit 26a. As previously mentioned, this wire / rod acts as a guide for the movement of the cutting blade. Subsequently, the surgeon drills the bone 14 using the opening 26 and the conduit 28a. The drill used has markings on the drill, which assist the surgeon by providing an indicator of whether the desired depth has been achieved as planned preoperatively. Once drilling is complete, the lug is inserted into these holes through the openings 26 and 28a. Together, the lug and the wire / rod inserted into 26a provide sufficient stability to the surgical guide device 10, which may then be used to make an incision in the bone. The excess length of the wire / rod inserted into the conduit 26a may be cut off, which facilitates the use of the cutting blade to make the incision.

[0088] Subsequently, the surgeon can make an incision in the bone by moving the incision blade through the incision slot 30 to the desired depth. The incision blade may have a scale to provide the surgeon with an indicator when the desired depth is reached.

[0089] In this regard, the surgeon can make an initial incision (for example, by using the blade posteriorly to the desired depth). Following this initial incision, the surgeon can remove the lug inserted into the opening 26 and the proximal component 16 and the wire / rod inserted into the conduit 26a to guide the incision, while the distal component 18 is left in place and the lug in the conduit 28a is retained. The surgeon can then make a final incision (for example, anteriorly), thereby completing the incision.

[0090] Following the completion of the incision, the surgeon can remove the distal component 18 along with the lug in the conduit 28a. The surgeon can then remove the rest of the surgical guidance device 10, leaving the wire / rod 44 in place. This completes the step of making the desired incision and using the surgical guidance device 10 for the incision.

[0091] After removing the surgical guidance device 10, the surgeon opens the incision to the desired angle according to the preoperative plan. Using different instruments, the incision may be gradually opened, and then a temporary wedge spacer may be inserted into the opened incision to hold it open in the desired position.

[0092] Next, the surgeon positions the osteotomy plate in place and uses the lugs again to hold the plate in place. Once the plate is in place, the surgeon can remove the lugs one by one and replace them with screws that are screwed into the perforations of openings 26, 28a. This secures the osteotomy plate in place. The temporary wedge spacers and wires / rods 44 are now removable, and the bone graft material can be inserted into the opened space, thus completing the procedure. The procedure can then be completed by the surgeon closing the area with sutures.

[0093] In addition to the steps described above, if the surgeon uses a surgical system with guide elements, an additional step is required to adjust the surgical guide device 10 using the guide elements. Ideally, this step is performed at the start of the surgery (i.e., before any drilling / incision of the bone is initiated). However, it should be understood that fine adjustments may be made throughout the procedure, after which the surgical guide device 10 is removed and the plate is screwed into place.

[0094] The above description of the use of the surgical system relates to procedures performed on the tibia, but surgeons can use similar steps to perform procedures on the femur using the guidance device disclosed herein. It should be understood that the number and location of openings, the dimensions of the incisions made, etc., may be modified for the femur.

[0095] The terms proximal and distal are generally interpreted in accordance with anatomical terminology referring to the origin of the limb being treated. In this regard, the portion of the guide device body 12 located near the origin of the limb is considered the proximal component 16, while the portion of the guide device body 12 located further away from the origin of the limb is considered the distal component 18 of the guide device. However, although the terms proximal and distal are used to refer to the anatomical location of the limb, when used with the femur, the proximal and distal portions of the surgical guide device may be reversed. In the configuration used with the femur, the distal portion includes the head and incision slot, while the proximal portion includes the conduit.

[0096] In the following claims and the preceding description of the invention, unless otherwise required by contextually explicit language or necessary implications, the word “comprise,” or variations such as “comprises” or “comprising,” is used in a comprehensive sense, that is, to identify the presence of the described features, but does not preclude the presence or addition of further features in various embodiments of the invention.

Claims

1. A surgical guidance device for assisting osteotomy, wherein the surgical guidance device is A guidance device body, wherein the guidance device body is molded and configured to be positioned relative to the patient's bone, and the guidance device body has a proximal component and a distal component that constitute the guidance device body, An incision slot extending through the main body of the guidance device, the incision slot being positioned to guide an incision into the patient's bone, A plurality of openings extending through the body of the guidance device for assisting the positioning of an implantable element and / or guiding drilling into the patient's bone, wherein at least one of the plurality of openings is a conduit extending through the body of the guidance device at a position adjacent to the incision slot, and the conduit is adapted to guide the insertion of a rod or wire into the patient's bone, An induction element configured to be positioned at a predetermined location relative to a characteristic portion located in the patient's bone, or a characteristic portion forming a part of the patient's bone, thereby supporting the correct positioning of the surgical induction device relative to the patient's bone during use; A surgical guidance device equipped with the following features.

2. The conduit extends through the proximal component of the guidance device body at a position proximal to the incision slot, and is configured to guide the insertion of a rod or wire into the patient's bone, according to claim 1, for use in surgical guidance devices.

3. The surgical guidance device according to claim 1, wherein the conduit extends through the distal component of the guidance device body at a position distal to the incision slot.

4. The surgical guidance device according to claim 1, wherein the guidance element comprises a guidance slot extending proximal from the distal edge of the distal component, and the size and position of the guidance slot are determined to be located around a rod or wire pre-inserted into the patient's bone.

5. The surgical guidance device according to claim 1, wherein the guidance element is positioned in correspondence with a desired anatomical landmark on the patient's bone, thereby positioning the surgical guidance device at a desired location on the patient's bone.

6. The surgical guidance device according to claim 5, wherein the guidance element is provided as a detachable component that is fixed to the surgical guidance device when in use.

7. The surgical guidance device according to any one of claims 1 to 5, wherein the proximal component and the distal component are detachably engaged with each other.

8. The surgical guidance device according to any one of claims 1 to 6, wherein the incision slot is located midway between the proximal component and the distal component.

9. The surgical guidance device according to any one of claims 1 to 7, wherein the conduit is tubular.

10. The surgical guidance device according to claim 5, wherein the guidance element is formed as part of the surgical guidance device.

11. The surgical guidance device according to claim 10, wherein the guidance element is formed on the proximal component of the surgical guidance device.

12. The surgical guidance device according to any one of claims 1 to 11, wherein the guidance element comprises a recess or groove corresponding to the characteristic portion of the anatomical landmark.

13. The surgical guidance device according to claim 12, wherein the recess or groove is provided with an indicator.

14. The surgical guidance device according to claim 13, wherein the indicator is formed from a K-wire or a fastening wire.

15. The surgical guidance system according to claim 13 or 14, wherein the indicator is manufactured from a radiopaque material.

16. The surgical guidance device according to claim 3 or any one of claims 4 to 13 incorporating claim 3, wherein the anatomical landmark includes a portion of the articular surface between two bones of the patient.

17. The surgical guidance device according to claim 13, wherein the articular surface includes a femoral condyle.

18. A surgical guidance device for assisting osteotomy, wherein the surgical guidance device is A guidance device body, wherein the guidance device body is molded and configured to be positioned relative to the patient's bone, and the guidance device body has a proximal component and a distal component that constitute the guidance device body, An incision slot extending through the main body of the guidance device, the incision slot being positioned to guide an incision into the patient's bone, A plurality of openings extending through the body of the guide device for assisting the positioning of an implantable element and / or guiding drilling into the patient's bone, wherein at least one of the plurality of openings is a conduit extending through the proximal component of the guide device body at a position proximal to the incision slot, and the conduit is adapted to guide the insertion of a rod or wire into the patient's bone, and Equipped with, At least one of the openings is provided with a guide slot extending proximal from the distal edge of the distal component, and the size and position of the guide slot are determined to be located around a rod or wire that has been pre-inserted into the patient's bone. Surgical guidance device.

19. A surgical guidance device for assisting osteotomy, wherein the surgical guidance device is A guidance device body, wherein the guidance device body is molded and configured to be positioned relative to the patient's bone, and the guidance device body has a proximal component and a distal component that constitute the guidance device body, An incision slot extending through the main body of the guidance device, the incision slot being positioned to guide an incision into the patient's bone, A plurality of openings extending through the body of the guide device for assisting the positioning of an implantable element and / or guiding drilling into the patient's bone, wherein at least one of the plurality of openings is a conduit extending through the proximal component of the guide device body at a position proximal to the incision slot, and the conduit is adapted to guide the insertion of a rod or wire into the patient's bone, A guide element, wherein the guide element is positioned in accordance with a desired anatomical landmark on the patient's bone, thereby positioning the surgical guide device at a desired location on the patient's bone. A surgical guidance device equipped with the following features.

20. A surgical guidance system, A surgical guidance device according to any one of claims 1 to 19, A preliminary guidance element comprising a preliminary guidance device body molded and configured to be positioned relative to the bone of a patient, and a conduit for positioning a rod or wire, and A surgical guidance system equipped with the following features.

21. A method for manufacturing a surgical guidance device according to any one of claims 1 to 19, wherein the surgical guidance device is for assisting in an osteotomy of a patient's bone, and the method comprises the steps of: performing at least one preoperative step on the patient to determine the preoperative state of the bone; and utilizing the output obtained as a result of the preoperative step to manufacture the surgical guidance device, wherein the surgical guidance device has a shape and configuration suitable for performing an osteotomy on the patient's bone.

22. The method according to claim 21, wherein the preoperative step includes one or more of X-ray imaging, computed tomography, and magnetic resonance imaging (MRI).

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