Surgical procedure guidance tool

Abstract

A surgical guide tool comprising a non-patient specific platform comprising one or more supports for attaching to a body part of a subject, a patient specific block having a top surface and a bottom surface, the block comprising a guide aperture extending from the top surface to the bottom surface for guiding a surgical instrument to make at least one of an incision and a bore, the block having a patient specific size such that when the surgical guide tool is attached to the body part of the patient and the block is firmly seated against the platform, the guide aperture has a desired alignment with respect to the body part, wherein the top surface and the bottom surface of the block are flat and non-parallel.

Description

[0001] Divisional application

[0002] This application is a divisional application of Chinese patent application No. 201880064878.8, which was filed on October 5, 2018, and is entitled "Drilling Platform Tool for Surgical Operation".

[0003] Cross-reference to related applications

[0004] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 569,023, filed October 6, 2017, entitled “Drilling Platform Tool for Surgical Procedures”, and U.S. Provisional Patent Application Serial No. 62 / 585,717, filed November 14, 2017, both of which are incorporated herein by reference in their entirety. Technical Field

[0005] This invention relates to a surgical tool and method for guiding surgical instruments, and more specifically, to a drilling platform tool that provides a clearly defined drilling or cutting path. Background Technology

[0006] Many surgical procedures require surgeons to drill and / or cut into bones or other parts of the body. For example, some patients may have hearing loss in one or both ears that is so severe that hearing aids cannot help, and could benefit from a cochlear implant. To insert a cochlear implant, surgeons typically have to perform surgery that requires drilling into the middle ear.

[0007] like Figure 1 As shown, a normal ear transmits sound through the outer ear 101 to the tympanic membrane (tympanic membrane) 102, which causes the bones (malleus, incus, and stapes) of the middle ear 103 to move, thereby causing the oval and round window openings of the cochlea 104 to vibrate. The cochlea 104 is a narrow, elongated duct that spirals about two and a half turns around its axis. The cochlea 104 includes a superior channel called the scala vestibulae and a inferior channel known as the scala tympani, which are connected by the cochlear duct. The scala tympani forms an upright spiral cone with a center called the cochlear axis, in which the spiral ganglion cells of the auditory nerve 113 reside. In response to the received sound transmitted by the middle ear 103, the fluid-filled cochlea 104 acts as a transducer to generate electrical impulses, which are transmitted to the cochlear nerve 113 and ultimately to the brain.

[0008] Hearing is impaired when there is a problem with the ability of the cochlear neural matrix to convert external sounds into meaningful action potentials. In this case, a cochlear implant is an auditory prosthesis that uses implanted stimulating electrodes to bypass the ear's auditory conversion mechanism and instead directly stimulates the auditory nerve tissue through small currents delivered by multiple electrode contacts distributed along the electrodes.

[0009] Figure 1 Also shown are some components of a typical cochlear implant system, including an external microphone that provides audio signal input to an external signal processing stage 111, where various signal processing schemes can be implemented. The processed signal is then converted into a digital data format (e.g., a series of data frames) for transmission to an implant stimulator 108. In addition to extracting audio information, the implant stimulator 108 performs additional signal processing (e.g., error correction, impulse formation, etc.) and generates a stimulation pattern (based on the extracted audio information), which is transmitted via a connected wire 109 to an electrode array 110 inserted into the cochlea. Typically, the electrode array 110 includes multiple electrode contacts on its surface that provide selective stimulation of the cochlea 104. Stimulation is performed either against an external reference electrode contact (i.e., a remote ground contact) outside the cochlea or against another electrode contact within the array inside the cochlea 104.

[0010] Insertion of the electrode array 110 typically involves making an incision behind the ear and then using a drill to access the middle ear. The electrode array 110 is placed through an opening created in the cochlea 104, and then the implant stimulator 108 is placed in a recess under the skin on the skull behind the ear.

[0011] Various prior art devices have been proposed to assist surgeons in performing such precise surgical drilling or other cuts. U.S. Patent No. 7,981,122 to Labadie et al. discloses various surgical guiding tools, including a guiding platform having adjustable-length legs resting on a body part. However, the assembly and adjustment of the legs' positioning on the body part can be time-consuming and expensive. To avoid the disadvantages of having adjustable legs, WO2016 / 198032 ( GmbH proposed a positioning aid with legs of fixed length. The guide plate in WO2016 / 198032 is manufactured for each patient based on the generated preoperative images, while other components of the system are reusable. In WO2016 / 198032, the calculated optimal drilling trajectory is achieved by providing a guide plate with a central axis perpendicular to the plate surface, through which the trajectory can be drilled eccentrically and at an angle to the axis. This may not be optimal, as the surgeon may therefore have to move the drill bit at an angle different from that perpendicular to the plate surface. Each of the above-cited references is incorporated herein by reference in its entirety. Summary of the Invention

[0012] According to an embodiment of the invention, a surgical guide includes a non-patient-specific platform comprising one or more supports for attachment to a body part of a patient. The non-patient-specific block has a top flat surface and a bottom flat surface, and includes a guide orifice extending from the top flat surface to the bottom flat surface for guiding surgical instruments to form at least one of incisions and drill holes. An intermediate module is removably positioned between the platform and the block. This intermediate module has patient-specific dimensions such that when the surgical guide is attached to a patient's body part and the intermediate module is positioned between the platform and the block, the guide orifice has a desired alignment with the body part.

[0013] According to a relevant embodiment of the present invention, the guide aperture may be a boring hole defining an axis passing through the block. This axis may be perpendicular to the top flat surface and the bottom flat surface of the block.

[0014] According to other relevant embodiments of the invention, the intermediate module may have a top module surface for positioning adjacent to the block and a bottom module surface for positioning adjacent to the platform. The intermediate module has a varying height between the top and bottom surfaces, such that when the surgical guide tool is attached to a patient's body part, the guide aperture is aligned with the desired body part. The top and bottom module surfaces may be flat and non-parallel.

[0015] According to other relevant embodiments of the invention, the platform's support may include a leg that is fixed and immovable relative to the platform and has a non-adjustable size. Both the intermediate module and the platform may be configured such that, when the intermediate module is positioned between the platform and the block, the intermediate module and the platform do not obstruct openings in the block. The block may be secured to the platform such that there is no freedom of play in one or more dimensions. The surgical instrument may also include a clamp for holding the platform, block, and / or intermediate module together. The platform, block, and / or intermediate module may include one of a protrusion, a recess, a pin, and / or a pin receiver to ensure proper positioning relative to each other.

[0016] According to another embodiment of the invention, a method includes providing a non-patient-specific platform for attachment to a body part of an object. A non-patient-specific block is provided having a top flat surface and a bottom flat surface, the block including a guide orifice extending from the top flat surface to the bottom flat surface for guiding surgical instruments. Electronic image data of an anatomical region of the object is obtained. A trajectory for at least one of incision and drilling is determined, at least in part, based on the electronic image data. An intermediate module is provided, configured to be removably positioned between the platform and the block, the intermediate module having patient-specific dimensions such that, when the platform is attached to a body part of the patient and the intermediate module is clamped between the platform and the block, the guide orifice in the block is configured to guide surgical instruments along the determined trajectory to form at least one of incision and drilling.

[0017] According to relevant embodiments of the present invention, obtaining electronic image data may include one or a combination of preoperative, intraoperative, optical, MRI, CT and spiral CT.

[0018] According to other relevant embodiments of the invention, the method may further include: mounting the platform onto a body portion with the intermediate module sandwiched between the platform and the block; and forming at least one of an incision and a drill hole in the body portion using the guide orifice. The body portion may be a skull, wherein the platform is mounted on the skull, and wherein the guide orifice is used to guide surgical instruments to drill through a hole into the middle ear from the skull, the method further including inserting an electrode array of a cochlear implant into the hole.

[0019] According to other relevant embodiments of the invention, the intermediate module may have a top module surface for positioning adjacent to the block and a bottom module surface for positioning adjacent to the platform. The intermediate module has a varying height between the top and bottom surfaces, such that when the surgical guide tool is attached to a patient's body part and the intermediate module is positioned between the platform and the block, the guide aperture is aligned with the desired alignment relative to the body part. The top and bottom module surfaces may be flat and non-parallel.

[0020] According to other relevant embodiments of the invention, the guide aperture may be a boring hole defining an axis passing through the block. This axis may be perpendicular to the top and bottom flat surfaces of the block. The platform may include a leg for attachment to a body portion, the leg being fixed and immovable relative to the platform, and having a fixed, non-variable dimension. When the intermediate module is sandwiched between the platform and the block, neither the intermediate module nor the platform obstructs the aperture in the block. Providing the intermediate module may include cutting, drilling, milling, and / or laser sintering the material blank.

[0021] According to another embodiment of the invention, a surgical guide includes a non-patient-specific platform comprising one or more supports for attachment to a body part of a patient. A patient-specific block has a top surface and a bottom surface, and includes a guide aperture extending from the top surface to the bottom surface for guiding surgical instruments to form at least one of incisions and drill holes. The block has patient-specific dimensions such that the guide aperture is preferably aligned with the body part when the surgical guide is attached to the patient's body part and the block is securely abutted against the platform. The top and bottom surfaces of the block are flat and non-parallel.

[0022] According to a relevant embodiment of the invention, the guide orifice may be a bore defining an axis passing through the block. A non-patient-specific predetermined arrangement may exist between this axis and the top surface of the block. Illustratively, a non-patient-specific predetermined angle may exist between the axis of the guide orifice and the top surface of the block, wherein the height variation between the top and bottom surfaces of the block is such that when the surgical guide tool is attached to a patient's body part and the block is securely abutted against the platform, this angle is in a desired alignment relative to the body part. The axis may be perpendicular to the top surface of the block. The platform's support includes non-patient-specific legs that are fixed and immovable relative to the platform and have non-adjustable dimensions. When the block is secured to the platform, there may be no freedom of movement in one or more dimensions. The surgical tool may include clamps for holding the block to the platform. The block and / or platform may include protrusions, recesses, pins, and / or pin receivers to ensure proper positioning of the block relative to the platform.

[0023] According to another embodiment of the invention, a method includes providing a non-patient-specific platform for attachment to a body part of an object. Electronic image data of an anatomical region of the object is obtained. A trajectory for forming at least one of an incision and a drill hole is determined, at least in part, based on the electronic image data. A patient-specific block is provided having a top surface and a bottom surface, the block including a guide orifice extending from the top surface to the bottom surface for guiding surgical instruments to form at least one of an incision and a drill hole. The top and bottom surfaces of the block are flat and non-parallel.

[0024] According to relevant embodiments of the present invention, obtaining electronic image data may include one or a combination of preoperative, intraoperative, optical, MRI, CT and spiral CT.

[0025] According to other relevant embodiments of the invention, the method may further include mounting the platform onto a body part while the block is securely abutted against the platform. At least one of forming an incision and drilling is performed on the body part using a guide aperture. The body part may be a skull, wherein the platform is mounted on the skull, and wherein the guide aperture is used to guide surgical instruments to drill through a hole into the middle ear from the skull, the method further including inserting an electrode array of a cochlear implant into the hole.

[0026] According to other embodiments of the invention, the block can be secured to the platform such that there is no freedom of movement in one or more dimensions. The guide orifice can be a bore defining an axis through the block. A non-patient-specific predetermined arrangement can exist between this axis and the top surface of the block. Illustratively, a non-patient-specific predetermined angle can exist between the axis of the guide orifice and the top surface of the block, wherein the height variation between the top and bottom surfaces of the block is such that when the surgical guide is attached to a patient's body part and the block is securely abutted against the platform, this angle is in a desired alignment relative to the body part. The axis can be perpendicular to the top surface of the block. The platform can include non-patient-specific legs for attachment to the body part, these legs being fixed and immovable relative to the platform, these legs having fixed dimensions that cannot be changed. Providing the block can include cutting, drilling, milling, and / or laser sintering a material blank. The block can be clamped to the platform. The block and / or platform may include one or a combination of protrusions, recesses, pins and pin receiving portions to ensure proper positioning of the block relative to the platform.

[0027] According to embodiments related to the above embodiments, the surgical guiding tool may include a guiding element that may be attached to or integral with the block. The guiding element may have a guiding wall, to which, for example, rollers are operatively coupled. When a drill or incision is made, the surgical instrument contacts these rollers to ensure that the surgical instrument moves through the guide opening without tilting. Attached Figure Description

[0028] The foregoing features of the embodiments will be more readily understood through the following detailed description with reference to the accompanying drawings, in which:

[0029] Figure 1 It shows the various anatomical structures of the human ear and the components of a typical cochlear implant system associated with it;

[0030] Figure 2 A composite view of a surgical guide tool according to an embodiment of the present invention is shown;

[0031] Figure 3 It shows Figure 2 An exploded view of the surgical guidance tools depicted in the image;

[0032] Figure 4A A top view of a platform according to an embodiment of the present invention is shown, while Figure 4B A side view of the platform is shown;

[0033] Figure 5AA top view of the intermediate module 203 according to an embodiment of the present invention is shown, while Figure 5B A side view of the intermediate module 203 is shown;

[0034] Figure 6 This is a flowchart illustrating a method according to an embodiment of the present invention, the method including manufacturing an intermediate module and further including performing a medical procedure;

[0035] Figure 7 The lateral offsets y and z between the platform and the intermediate module according to an embodiment of the present invention are shown; and

[0036] Figure 8A (Top view) and Figure 8B (Side view) shows a patient-specific block of a surgical guide tool without an intermediate module according to an embodiment of the present invention.

[0037] Figure 9 A guide element according to an embodiment of the present invention is shown. Detailed Implementation

[0038] In illustrative embodiments of the invention, a surgical guidance tool and method are provided for guiding surgical instruments to form incisions and / or drill holes in a subject's body. In exemplary embodiments, the surgical guidance tool can be used when drilling holes in a patient's skull (and more specifically, in the middle ear) to facilitate the insertion of an electrode array for a cochlear implant. However, it should be noted that the provided surgical tool and method are not limited to the skull but can also be applied to other parts of the body. Details thereof are described below.

[0039] Figure 2 A composite view of a surgical guide 200 according to an embodiment of the present invention is shown. Figure 3 It shows Figure 2 An exploded view of the surgical guidance tool 200 depicted in the image.

[0040] The surgical guidance tool 200 includes a non-patient-specific platform 201 having a plate 210. One or more supports 211 can be secured to the plate 210, the supports 211 being used for attachment to a body part 250 of the object. The supports 211 may include (but are not limited to) one or more legs 211. The legs 211 may have a fixed size and shape that cannot be changed. The legs 211 may be integral with the plate 210, or attached to the plate 210 at one end, for example by screws or welding, such that the legs 211 are fixed and immovable relative to the platform 201. The other end of each leg 211 is used for resting on the body part and may include various attachment mechanisms 212 known in the art (e.g., screws or pins) for securing the legs and thus the platform 201 to the body part 250.

[0041] According to an embodiment of the present invention, Figure 4A A top view of platform 201 is shown, and Figure 4B A side view of platform 201 is shown. Platform 201 may include an opening 213. The opening 213 is a cavity that extends from one side of plate 210 to the other and may be wholly or partially surrounded by plate 210. For example, plate 210 may have (but is not limited to) the following characteristics: Figure 4A The L-shape is shown. In other embodiments, plate 210 may be circular or rectangular in form, or have other forms that support the surgical procedures described further below. Plate 210 has a top surface 214 on which the block can be placed, for example, as described in more detail below.

[0042] Return to reference Figure 2 and Figure 3 The surgical guide 200 also includes a non-patient-specific block 202 having a flat top surface 220 and a flat bottom surface 221. (As...) Figure 1 and Figure 2 As shown, when the surgical guide 200 is attached to the body portion 250, the bottom surface 221 of the block 202 is closer to the body portion 250. The block 202 includes a guide aperture 222 extending from the top flat surface 220 to the bottom flat surface 221 for guiding surgical instruments to form at least one of incisions and drill holes.

[0043] In an illustrative embodiment of the invention, block 202 can be used as a drilling platform, wherein the guide orifice 222 is a boring hole 222 that defines an axis 223 passing through block 202. A non-patient-specific predetermined arrangement may exist between axis 223 and the top surface 220 of block 202. For example, but not limited to, axis 223 may be perpendicular to the top flat surface 220 and the bottom flat surface 221 of block 202. This can be advantageous to the surgeon because it is generally easier to hold and move a drill bit perpendicular to the surface orientation compared to other angles. However, axis 223 may also not be perpendicular to the top flat surface 220 and the bottom flat surface 221 of block 202. Compared to conventional drilling stages such as those described in WO2016 / 198032, not only can the non-patient-specific platform 201 be manufactured in a manner independent of body parts 250 (e.g., the patient's skull), but the non-patient-specific block 202 can also be manufactured in a manner independent of body parts 250 (e.g., the patient's skull), and for many patients, the non-patient-specific platform 201 and the non-patient-specific block 202 can be reusable.

[0044] like Figure 2 and Figure 3 As shown, the surgical guide 200 also includes an intermediate module 203, which is removably clipped between the platform 201 and the block 202. The intermediate module 203 has a patient-specific, customized size such that when the surgical guide 200 is attached to the patient's body portion 250 and the intermediate module 203 is positioned between the platform 201 and the block 202, the guide orifice 222 has the desired alignment relative to the body portion 250. Therefore, regardless of the alignment of the guide orifice 222 in the reusable, non-patient-specific block 202, the patient-specific intermediate module 204 ensures that the guide orifice 222 is properly aligned to form an incision or drill hole.

[0045] According to an embodiment of the present invention, Figure 5A A top view of the intermediate module 203 is shown, while Figure 5BA side view of intermediate module 203 is shown. Intermediate module 203 includes a top module surface 234 for positioning close to and / or adjacent to block 202 and a bottom module surface 235 for positioning close to and / or adjacent to platform 201. In various embodiments, the top module surface 234 and the bottom module surface 235 are flat and non-parallel. The height between the top module surface 234 and the bottom module surface 235 can vary over a region of intermediate module 203 such that when surgical guide 200 is attached to patient body part 250, guide aperture 222 has the desired alignment relative to body part 250. For example, if intermediate module 203 is formed in an L-shape, at least some of heights 530, 531, and 532 can be different (see [link to relevant documentation]). Figure 5A and Figure 5B ).

[0046] From the top view, the intermediate module 203 can have a different form than the board 210, or the intermediate module 203 and the board 210 can have similar forms, such as... Figure 5A As exemplarily shown in the top view. In any case, the intermediate module 203 has an opening 233, the boundary of which should not cover the opening 213 of the plate 210 when the platform 201 and the intermediate module 203 are adjacent to each other.

[0047] Although the basic forms of plate 210 and intermediate module 203 may be similar, their lateral dimensions may differ. This is determined by the length x' of plate 210 (see...). Figure 4A ) and the length x of intermediate module 203 (see Figure 5A (Example representation). x' can be approximately equal to x”, however, in various embodiments, x” can also be greater than x' for reasons further outlined below. Similarly, the length perpendicular to either x' or x” can be different.

[0048] The intermediate module 203 can be manufactured as a single-use module during the medical procedure, or it can be manufactured preoperatively. Because the size of the intermediate module 203 is patient-specific, it is manufactured individually for each patient and can be used only once before being discarded. In contrast, the platform 201 and block 202 are not patient-specific and can be reused by individual patients.

[0049] Figure 6This is a flowchart illustrating a method according to an embodiment of the present invention, which includes manufacturing intermediate modules and performing medical procedures. Steps 601 and 603 involve providing a non-patient-specific platform and block. The surgeon can select from a set of platforms / plates best suited to the anatomy of the patient's body part and the anatomical region of interest (e.g., but not limited to the skull). The platform may include marker elements used during subsequent imaging of the patient's body part and the anatomical region of interest. The marker elements may be visible on the acquired patient images and may facilitate determining the position and orientation of the platform relative to the patient region of interest.

[0050] Step 604: Obtain electronic imaging data of the patient's anatomical region of interest. This acquisition can be performed intraoperatively or alternatively preoperatively. Electronic imaging data can be obtained via MRI, CT, and / or spiral CT. Optical acquisition is also possible.

[0051] Step 605: Determine the trajectory to be cut or drilled based on electronic image data. For example, a dedicated software module running on a processor can analyze the electronic image data and calculate parameters for the trajectory to be drilled. Illustratively, this could be the optimal trajectory from the skull behind the patient's ear to the middle ear when inserting an electrode array for a cochlear implant. Important trajectory parameters may include (but are not limited to) its trajectory 251 (e.g., Figure 1 (as shown in the diagram) and the point where the axis intersects the surface of the skull.

[0052] Step 607: Based on these trajectory parameters, suitable intermediate modules and their feature module parameters can be determined and manufactured. If the intermediate module is as follows... Figure 5A and Figure 5B As shown in the L-shape, the feature module parameters may include (but are not limited to) heights 530, 531, and 532, and lateral offsets y and z between platform 201 and intermediate module 301, such as... Figure 7 As exemplarily shown in the figure. In various embodiments, the feature module parameters also include a lateral offset between the intermediate module and the block. Reference Figure 2 These offsets can be used to ensure that, in the composite surgical guide tool 200, the axis 223 of the bore 222 in the block 202 coincides with the determined trajectory 251.

[0053] A wide variety of mechanical processes can be used in manufacturing the intermediate module. These processes may include (but are not limited to) cutting from a blank of suitable material, drilling, milling, etc. In other embodiments, the intermediate module may be molded.

[0054] Step 609: Once the intermediate module is provided, the platform can be installed on the body part, wherein the intermediate module is sandwiched between the platform and the block. (Illustratively, as shown...) Figure 1 As shown, the drilling platform 201 can be mounted on the patient's skull 250, with the intermediate module 203 and subsequent drilling stage 202 located on the drilling platform 201. In the combined state, with the surgical guide 200 mounted on the body to perform the drilling procedure, the longitudinal axis 223 of the boring 222 coincides with the longitudinal axis of the desired predetermined trajectory 251 in the skull 250.

[0055] In step 611, the surgeon or robot can then insert surgical instruments through the guide orifice to form an incision or drill hole. The intermediate module ensures that the trajectory or surgical instrument follows the desired trajectory. Additionally, as described above, in various embodiments of the invention, the longitudinal axis of the guide orifice in the non-patient-specific block can be perpendicular to the surface of the drilling platform. This can be advantageous to the surgeon because it makes it easier to hold and move a drill bit oriented perpendicular to the block surface compared to other angles.

[0056] In various embodiments, as shown in FIG. 4, position-defining elements may be present on the surface 214 of platform 201 and / or plate 210. These position-defining elements may be, for example, longitudinal, dot-shaped, or conical protrusions. In FIG. 4, the position-defining element is shown as a longitudinal protrusion in two dimensions of plane 415. During manufacturing, corresponding recesses may be milled into the bottom surface 235 of intermediate module 203. Alternatively, the protrusion may be in the bottom surface 235, and the recess may be on platform 201 or plate 210. Similar protrusions and recesses may be present on / in the surface 234 of intermediate module 203 and the surface 221 of block 202.

[0057] An alternative solution to provide protrusions and recesses, or combinations thereof, could be cylindrical pins extending from platform 201 and / or plate 210 and / or recesses formed by drilling during the medical procedure as described above. In some cases, the intermediate module 203 may need to be larger than plate 210 and / or block 202 in one or two dimensions of the respective surface plane, thereby enabling possible displacements y and z. It would be advantageous to have at least two cylindrical pins / recesses on each surface. In embodiments where the intermediate module 203 is fabricated intraoperatively during the medical procedure, it may be advantageous for the intermediate module 203 to receive recesses while protrusions (pins) are provided to platform 201 / plate 210 and / or block 202.

[0058] One purpose of these complementary structural elements, the protrusions (pins) and recesses, is to ensure that the platform 201 / plate 210, block 202, and intermediate module 203 fit together without clearance at predetermined positions calculated (but not limited to) by the processor software, guaranteeing the coincidence of trajectory 251 and axis 223. In other embodiments, a jig (not shown) may be used to hold all three components 201, 202, and 203 together.

[0059] In other embodiments of the present invention, such as Figure 8A (Top view) and Figure 8B As shown in the (side view), the surgical guidance tool described herein can be implemented without intermediate modules. For this purpose, the various portions of block 802 can be patient-specific to ensure that the defined trajectory coincides with the axis 823 of the guide orifice 822.

[0060] Schematic, the patient-specific block 802 may have flat and non-parallel top and bottom surfaces, wherein at least some of heights 824, 825, 826, and 827 are assumed to have different values. Heights 824, 825, 826, and 827 are patient-specific to ensure that a proper predetermined angle / track is provided in the non-patient-specific predetermined arrangement between the axis 823 of the guide hole 822 and the top surface of the block 802. Similar to the embodiments described above, axis 823 may be perpendicular to the top flat surface 820 of the block 802. However, in other embodiments, axis 823 may not be perpendicular to the top flat surface 820. The bore 822 may be at the center of the block 802 or off-center.

[0061] During, for example, the insertion of the boring device into the patient's skull, a trade-off may need to be struck between the dimensions of the bore 222 / 822 and the precise alignment of the axis 223 / 823 and the trajectory 251. On the one hand, the bore 222 / 822 must precisely match the dimensions of the portion of the boring device that moves through the block 202 during drilling by the force of the surgeon (or robot) to avoid unintended angles between the axis 223 / 823 and the trajectory 251. On the other hand, the more precisely the outer diameter of this portion of the boring device matches the inner diameter of the bore 222 / 822, the greater the frictional force between the two portions may be. However, greater frictional force may increase the risk of unintended tilting of the boring device during insertion, causing the axis 223 / 823 and the trajectory 251 to no longer be perfectly aligned. To avoid this situation, a guide element (which may be an integral part of the block 202) may be present, for example, which can be attached to the surface 220 of the block 202, and keeps the boring device in an orientation that ensures perfect alignment of the axis 223 / 823 and the track 251 during drilling.

[0062] Figure 9A guide element according to an embodiment of the invention is shown. The guide element may include a guide wall 950, wherein, for example, a guide roller 951 is operably coupled to the guide wall 950, which ensures that a portion 960 of the boring device moves without lateral tilt and that the axes 223 / 823 and the track 251 are always perfectly aligned during drilling. The roller can have various shapes and is generally (but not limited to) wheel-shaped, circular, cylindrical, or spherical. Compared to the invention disclosed in WO2016 / 198032, this guide element of the boring device can advantageously be coupled with, for example... Figure 2 The systems shown are used in combination because the entire block 202 can be manufactured in a non-patient-specific manner. Therefore, the angle of axis 223 relative to surface 220 of block 202 is patient-independent, and the guiding element can be oriented accordingly. Furthermore, although the block 802 is patient-specific in the embodiment of FIG8, the angle between surface 820 and axis 823 is non-patient-specific, thus the guiding element can also be easily oriented accordingly.

[0063] The embodiments of the present invention described above are intended to be exemplary only; many variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention.

Claims

1. A surgical guidance tool, comprising: A non-patient-specific platform, the non-patient-specific platform including one or more supports for attachment to a body part of an object; A patient-specific block having a top surface and a bottom surface, the block including a guide orifice extending from the top surface to the bottom surface for guiding surgical instruments to form at least one of incisions and drill holes, the block having patient-specific dimensions such that when the surgical guide is attached to the patient's body part and the block is securely abutted against the platform, the guide orifice has a desired alignment with the body part, wherein the top and bottom surfaces of the block are flat and non-parallel. Wherein, the guide hole is a boring hole, the boring hole defining an axis passing through the block, and The axis is perpendicular to the top surface of the block.

2. The surgical guidance tool according to claim 1, wherein, There exists a non-patient-specific predetermined angle between the axis of the guide orifice and the top surface of the block, and wherein the height variation between the top and bottom surfaces of the block is such that when the surgical guide is attached to the patient's body part and the block is securely abutted against the platform, the angle is in a desired alignment relative to the body part.

3. The surgical guidance tool according to claim 1, wherein, The platform's support includes non-patient-specific legs that are fixed and immovable relative to the platform and have non-adjustable dimensions.

4. The surgical guidance tool according to claim 1, wherein, When the block is stabilized to the platform, it has no freedom of movement in one or more dimensions.

5. The surgical guide tool according to claim 1 further includes a clamp for clamping the block onto the platform.

6. The surgical guidance tool according to claim 1, wherein, The block and / or the platform includes one or a combination of a protrusion, a recess, a pin, and a pin receiving portion to ensure proper positioning of the block relative to the platform.

7. The surgical guide tool according to claim 1, further comprising a guide element, the guide element comprising a guide wall.

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