Guider capable of accurately guiding drilling hole

Abstract

The invention provides a guider capable of accurately guiding drilling. The guider comprises a bearing part, a guide pipe and a mounting column; the guide pipe is arranged on the first side of the bearing part; the mounting column is arranged on the second side of the bearing part, and the first side and the second side of the bearing part are opposite; the mounting column is used for connecting the guider with a prosthesis test mold or an osteotomy plate; through guide holes are formed in the guide pipes and the mounting columns corresponding to the guide pipes and used for accurately guiding drill bits penetrating through the guide holes, and drill holes meeting the requirement of prosthesis mounting are formed in the human bone.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a guide for precise drilling guidance. Background Art

[0002] In artificial joint replacement surgery, the positioning of joint prostheses often requires first simulating the installation with a prosthesis trial mold to determine a relatively ideal installation position, and then drilling a number of installation holes in the human bone. The prosthesis is installed and fixed through these holes to achieve the replacement of the artificial joint.

[0003] A biological prosthesis refers to a prosthesis that initially realizes bone ingrowth through physical wedging and press-fitting fixation and usually does not require bone cement fixation during the surgical process. Biological prostheses can be divided into columnar and non-columnar types. Among them, non-columnar biological prostheses require special tools to obtain an installation structure adapted to the prosthesis; columnar biological prostheses have a cylindrical, or square-columnar, or hexagonal-columnar, or irregular-columnar shape and can be installed into the round holes drilled by a drill bit. There needs to be a certain press-fit amount (interference fit) between the column and the hole to stimulate bone ingrowth, achieve long-term effective fixation of the prosthesis, and reduce the risk of revision due to prosthesis loosening. Therefore, in the surgery of columnar biological prostheses, the relative position, diameter, and relative angle of multi-hole drilling are particularly important, which determines the success rate of the patient's surgery and the service life of the prosthesis. Another type of cemented prosthesis can apply bone cement between the column and the hole, and has a lower requirement for the position accuracy of the hole.

[0004] The general surgical procedure is to install the prosthesis trial mold after osteotomy to simulate joint movement to confirm the specific position of the prosthesis. The existing guiding structures are commonly integrated with the prosthesis trial mold or osteotomy plate, and some through positioning holes on the prosthesis trial mold or osteotomy plate are directly used as guiding structures, enabling the drill bit of the electric drill to drill installation holes in the human bone through the positioning holes. However, the prosthesis trial mold is very similar in structure to the prosthesis to be installed (for example, except for the absence of columns, the other parts of the prosthesis trial mold have almost the same appearance size and joint surface as the prosthesis). The opening of the positioning holes is restricted by the structural characteristics of the prosthesis and its trial mold itself. For example, the relatively thin thickness of the prosthesis trial mold in some parts will result in shallower positioning holes opened here, and the distance of lateral support and restraint for the drill bit is shorter, making it impossible to achieve precise drilling guidance; another example is that some components for fixing and adjusting the osteotomy plate or tools for performing osteotomy operations need to be configured on the osteotomy plate, and the opening of the positioning holes is also restricted by these structures, making it impossible to achieve precise drilling guidance. Therefore, the existing guiding structures can only restrict the diameter and approximate position of the drilling. When there are multiple drillings, it is difficult to restrict the relative position and relative angle between the holes. Summary of the Invention

[0005] The object of the present invention is to provide a guide for precise drilling guidance, which can be assembled with a prosthesis trial mold or an osteotomy plate to precisely guide a drill bit, ensuring that the relative position, diameter, relative angle, etc. of the drilled hole meet the requirements for prosthesis installation.

[0006] The technical solution of the present invention lies in providing a guide, which comprises:

[0007] A bearing part, having opposite first and second sides;

[0008] A guide tube, arranged on the first side of the bearing part;

[0009] An installation post, arranged on the second side of the bearing part; the installation post is used to connect the guide with a prosthesis trial mold or an osteotomy plate;

[0010] A through guide hole is provided in the guide tube and the corresponding installation post, for guiding a drill bit passing through the guide hole.

[0011] Optionally, the guide hole is axially opened along the guide tube where it is located and extends into the installation post corresponding to the guide tube; the inlet end of the guide hole corresponds to the opening at the end of the guide tube away from the bearing part, and the outlet end of the guide hole corresponds to the opening at the end of the installation post away from the bearing part, so that the outlet end of the guide hole faces the target area on the human bone where drilling is to be performed.

[0012] Optionally, the drill bit guided by the guide hole is used to drill a hole in the target area on the human bone faced by the outlet end of the guide hole, so that when a prosthesis is installed onto the human bone, the posts on the prosthesis can be correspondingly inserted into the drilled holes.

[0013] Optionally, the angle between the guide tube and the first side surface of the bearing part and the angle between the column body of the installation post and the second side surface of the bearing part are the same or different.

[0014] Optionally, the angle between the guide hole and the bearing part remains unchanged from the inlet end to the outlet end.

[0015] Optionally, one or more guide tubes are provided on the bearing part.

[0016] Optionally, when there are multiple guide tubes, the angles between these guide tubes and the first side surface of the bearing part are the same or different.

[0017] Optionally, when there are multiple guide tubes, these guide tubes have the same or different lengths.

[0018] Optionally, the guide is provided with two guide tubes, which are respectively perpendicular to the first side surface of the bearing part, or respectively inclined to the first side surface of the bearing part with the same or different inclination angles, or one is perpendicular to the first side surface of the bearing part and the other is inclined to the first side surface of the bearing part.

[0019] Optionally, the guide has three guide tubes, which are respectively perpendicular to the first side surface of the bearing part, or respectively inclined to the first side surface of the bearing part with the same or different inclination angles, or two of the guide tubes are perpendicular to the first side surface of the bearing part and the other is inclined to the first side surface of the bearing part, or one of the guide tubes is perpendicular to the first side surface of the bearing part and the other two guide tubes are inclined to the first side surface of the bearing part with the same or different inclination angles.

[0020] Optionally, the diameter of the guide hole is 0.2 mm or less larger than the diameter of the drill bit.

[0021] Optionally, the wall thickness of the guide tube is 1 - 1.5 mm.

[0022] Optionally, the guide hole has a sufficient length such that when the drill bit drills a hole, a part of the drill bit or a part of the connecting rod connected to the drill bit is located in the guide hole.

[0023] Optionally, the relationship between the aperture d of the guide hole and the guide length H is H / d≥2.5.

[0024] Optionally, the guide is made of stainless steel.

[0025] Optionally, the guide is heat-treated after machining to improve its hardness.

[0026] Optionally, the first side of the bearing part is provided with a reinforcing rib connected to the guide tube.

[0027] Optionally, one side edge of the reinforcing rib is connected to the outer side of the wall of one guide tube; the other side edge of the reinforcing rib is connected to the outer side of the wall of another guide tube or connected to another reinforcing rib.

[0028] Optionally, the edge of the end of the reinforcing rib close to the bearing part is connected to the first side surface of the bearing part or is spaced apart from the first side surface of the bearing part.

[0029] Optionally, the angle between the reinforcing rib and the first side surface of the bearing part is the same as or different from the angle between the guide tube and the first side surface of the bearing part.

[0030] Optionally, the column body of the mounting post is fitted with the mounting hole on the prosthesis trial mold or the osteotomy plate and is inserted into the corresponding mounting hole for connecting the guide to the prosthesis trial mold or the osteotomy plate as a whole.

[0031] Optionally, an elastic ring is provided between the outer wall of the column body of the mounting post and the inner wall of the mounting hole, or the elastic ring is omitted.

[0032] Optionally, the number of the mounting posts is greater than or equal to the number of the guide tubes.

[0033] Optionally, the mounting post at least includes a first mounting post; the first mounting posts correspond to the guide tubes one by one and are internally connected to form the guide holes.

[0034] Optionally, when the number of the mounting posts is greater than the number of the guide tubes, a second mounting post is further included; the second mounting post does not correspond to the guide tube, and no guide hole is formed inside the second mounting post.

[0035] Optionally, the prosthetic trial mold or the osteotomy plate is provided with a bone contact surface that can contact the bone interface of the human bone; the bone interface has the original surface morphology of the human bone or has the surface morphology after surgical treatment.

[0036] Optionally, when the column body of the mounting post is inserted into the mounting hole on the prosthetic trial mold or the osteotomy plate, the end surface of the end of the mounting post away from the bearing part and the bone contact surface on the prosthetic trial mold or the osteotomy plate around the end surface cooperate to form a characteristic structure that can be complementary to and fit the bone interface.

[0037] Optionally, the prosthetic trial mold or the osteotomy plate is further provided with a support surface for supporting the bearing part, and the support surface is any exposed surface on the prosthetic trial mold or the osteotomy plate other than the bone contact surface.

[0038] Optionally, when the column body of the mounting post extends from the second side surface of the bearing part and is inserted into the mounting hole, the support surface of the prosthetic trial mold or the osteotomy plate is closely attached to the second side surface of the bearing part.

[0039] Optionally, one or more specifications of prosthetic trial molds or osteotomy plates are configured, and a variety of guides with different guide hole arrangements are configured; the prosthetic trial mold or the osteotomy plate that meets the prosthetic adaptation or osteotomy requirements of the current bone interface is connected to one of the guides to meet the requirements of at least part of the drilling targets in the target area.

[0040] Optionally, the different guide hole arrangements include at least one of the following differences: the diameter of the guide hole, the position of the guide hole, the angle of the guide hole, the relative position of different guide holes, and the relative angle of different guide holes.

[0041] Optionally, the guide meets the requirements of at least part of the drilling targets in the target area, including:

[0042] Configuring a single guide that can be connected to the prosthetic trial mold or the osteotomy plate, and all the guide holes corresponding to all the drilling targets in the target area are formed on the single guide;

[0043] Alternatively, a plurality of guides that can be connected to the prosthetic trial mold or the osteotomy plate in sequence are configured, and guide holes corresponding to all drilling targets in the target area are dispersedly formed on the plurality of guides.

[0044] Optionally, the prosthesis comprises a column-type bio-type prosthesis.

[0045] Optionally, the column of the column-type bio-type prosthesis is interference fit with the drilled hole.

[0046] Optionally, the prosthesis is an ankle tibial plateau prosthesis; the prosthesis trial mold is an ankle tibial plateau prosthesis trial mold; and the osteotomy plate is an osteotomy plate used for performing osteotomy on the proximal tibia in total knee replacement surgery.

[0047] Optionally, the prosthesis is a unicompartmental tibial plateau prosthesis; the prosthesis trial mold is a unicompartmental tibial plateau prosthesis trial mold; and the osteotomy plate is an osteotomy plate used for performing osteotomy on the medial or lateral side of the proximal tibia in unicompartmental replacement surgery.

[0048] The present invention has at least the following technical effects:

[0049] The guide provided in the embodiment of the present invention can accurately guide the drill bit to accurately drill the holes required for installing the columns of the artificial prosthesis, meet the requirements of the drilling position, diameter, angle, relative position and relative angle of the holes, reduce the repairs caused by inaccurate drilling during the operation, preserve the patient's own bone tissue as much as possible, and thus increase the service life of the artificial prosthesis.

[0050] The guide provided in the embodiment of the present invention is made separately and then connected to a prosthesis trial mold or osteotomy plate that meets the prosthesis adaptation or osteotomy requirements of the current bone interface. The doctor does not need to repeatedly install and disassemble different devices on the human bone, which effectively simplifies the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 It is a schematic structural diagram of a guide device according to a first embodiment of the present invention, which is provided with two inclined guide tubes.

[0052] Figure 2 yes Figure 1 A top view of the guide shown.

[0053] Figure 3 It is a schematic diagram of the structure of the guide device of the second embodiment of the present invention, which is provided with two vertical guide tubes.

[0054] Figure 4 It is a schematic diagram of the structure of the guide device of the third embodiment of the present invention, which is provided with three different guide tubes.

[0055] Figure 5 yes Figure 4Top view of the shown guide

[0056] Figure 6 It is a schematic structural view of the O-ring in the guide of the present invention

[0057] Figure 7 It is a schematic structural view of the C-ring in the guide of the present invention

[0058] Figure 8 It is a schematic view of an example where a reinforcing rib is provided on a single guide tube of the guide of the present invention

[0059] Figure 9 It is a schematic view of another example where a reinforcing rib is provided on a single guide tube of the guide of the present invention

[0060] Figure 10 、 Figure 11 、 Figure 12 、 Figure 13 They are schematic views of different examples where the reinforcing ribs are provided between adjacent guide tubes of the guide of the present invention

[0061] Figure 14 It is a schematic view when the ankle joint tibial plateau prosthesis is installed on the tibia

[0062] Figure 15 It is a schematic view when the guide of the present invention cooperates with the trial mold of the ankle joint tibial plateau prosthesis to simulate installation on the tibia

[0063] Figure 16 It is a schematic view when the unicompartmental tibial plateau prosthesis is installed on the tibia

[0064] Figure 17 It is a schematic view when the guide of the present invention cooperates with the trial mold of the unicompartmental tibial plateau prosthesis to simulate installation on the tibia Detailed implementation manners

[0065] As Figures 1 to 5 shown, a guide provided by the present invention includes a bearing part 10. A guide tube 20 is provided on the first side of the bearing part 10, and a mounting post 40 is provided on the second side opposite to the first side. The mounting post 40 is used to connect the guide to a prosthesis trial mold or an osteotomy plate as a whole; at least part of the mounting post 40 corresponds to the guide tube 20, and a through guide hole 30 is provided in the corresponding guide tube 20 and mounting post 40. When the prosthesis trial mold or the osteotomy plate assembled with the guide is installed on the target area of the human bone ( Figure 15 、 Figure 17 ), an external drill bit (not shown) passes through the guide hole 30 of the guide to drill the human bone, so that when installing the prosthesis subsequently, the post 83 on the prosthesis can be correspondingly inserted into the drilled hole for installation ( Figure 14 、 Figure 16 )

[0066] The bearing part 10 is generally a plate-like structure; when the bearing part 10 is sufficient to accommodate the guide tube 20, the mounting post 40, etc. arranged in a manner that meets the set requirements (for example, but not limited to, the arrangement of the guide and the mounting post 40 makes the guide hole 30 meet the drilling requirements, the setting of the mounting post 40 meets the requirements for reliable connection between the guide and the prosthesis trial mold or the osteotomy plate, the second side surface 12 of the bearing part 10 matches the support surface 75 provided for mounting the guide on the prosthesis trial mold or the osteotomy plate, etc.), there are no requirements or restrictions on the projected shape of the plate structure.

[0067] The guide hole 30 is set according to the drilling requirements for the installation of the column 83, including but not limited to making the diameter, position, and angle of each drilling, and when multiple drillings are involved, the relative position and relative angle between the holes all meet the requirements. For example, the diameter of the guide hole 30 has a small difference from the diameter of the drill bit. For example, the diameter of the guide hole 30 is larger than the diameter of the drill bit by within 0.2 mm, which has a good guiding effect. On the premise of not blocking the extension of the drill bit, not interfering with the human body parts around the guide, not affecting the drilling or the operation of other devices, and taking into account the overall aesthetics, etc., the guide hole 30 can have a sufficient length. In this way, during the drilling process, the drill bit and / or the connecting rod connected to the drill bit can still have a sufficient length part guided and constrained in the guide hole 30 and will not shift, so as to provide a more accurate and stable guide for the drill bit. As an example, the relationship between the aperture d of the guide hole and the guide length H: H / d≥2.5.

[0068] According to the number requirement of the drillings, one or more guide tubes 20 are provided on the bearing part 10. The inner diameter, position, and angle of the guide tube 20, and when multiple guide tubes 20 are provided at the same time, the relative position and relative angle between the tubes, etc. are all set to ensure that the guide hole 30 axially opened along the guide tube 20 can meet the drilling requirements.

[0069] When there are multiple guide tubes 20, these guide tubes 20 and the first side surface 11 of the bearing part 10 can have the same included angle (such as Figure 1 、 Figure 3 ), or have different included angles, or the included angle between one or some of the guide tubes 20 and the first side surface 11 of the bearing part 10 can be different from the included angle between other guide tubes 20 and this surface (such as Figure 4 ); the included angle between each guide tube 20 and the first side surface 11 needs to be set according to the drilling requirements.

[0070] For another example, when there are multiple guide tubes 20, these guide tubes 20 can have the same length (such as Figure 1 、 Figure 3 ), or have different lengths (such as Figure 17), or the length of one or some of the guide tubes 20 is different from that of the other guide tubes 20 (such as Figure 4 ); for the length of each guide tube 20, factors such as whether it is convenient for drilling operations, whether it interferes with the human body parts near the guide, whether it affects the arrangement or operation of other devices (such as prosthesis trial molds, osteotomy plates, or osteotomy tools), or the overall aesthetics of the guide can be considered for specific settings.

[0071] In different examples, all drilling targets in the current target area can be completed by one guide that is assembled with a prosthesis trial mold or an osteotomy plate, so that all drill holes have corresponding guide holes 30 on the same guide. Or, the prosthesis trial mold or the osteotomy plate can be assembled with multiple guides with different guide holes 30 in sequence, and each guide only needs to be responsible for guiding during the drilling of a part of the current area. Or, the prosthesis trial mold or the osteotomy plate can be assembled with guides with different guide hole 30 opening conditions respectively to adapt to the drilling requirements of different patient individuals, with better flexibility. By setting and assembling guides, prosthesis trial molds, or osteotomy plates of different specifications in this way, the needs of personalized surgery can be met; it is also more convenient to maintain the guides, prosthesis trial molds, or osteotomy plates separately. Also assume that when an individual has specific drilling requirements or prosthesis fitting / osteotomy requirements (such as different individuals having the same drilling requirements and different prosthesis fitting / osteotomy requirements, or having the same prosthesis fitting / osteotomy requirements and different drilling requirements), the guides, prosthesis trial molds, or osteotomy plates can also be customized separately and assembled as needed, without requiring the overall customization of the instrument. When the prosthesis trial mold or osteotomy plate in the prior art directly opens positioning holes for guiding, it is difficult to meet similar flexible customization requirements; the implementation scheme of the present invention can effectively reduce costs and improve the user experience.

[0072] The guide tube 20 is generally a thin-walled cylindrical structure, and the wall thickness of the example is about 1-1.5 mm. In some joint replacement surgeries (such as unicompartmental replacement surgery), the replaced prosthesis is small, and the drilling joint surface matched with it is also small. Due to space limitations, it is impossible to use a guide tube 20 with a thicker wall for the guide assembled with the prosthesis trial mold or the osteotomy plate.

[0073] In some examples, a reinforcing rib 60 is further provided on the first side of the bearing portion 10 and beside the guide tube 20 to enhance the stiffness of the guide tube 20 and avoid the situation of difficult processing and easy deformation when the wall thickness of the guide tube 20 is thin. There are no specific requirements or restrictions on the structure of the reinforcing rib 60. While meeting the requirements of stiffness improvement, for example, considering the layout space on the bearing portion 10, as well as not blocking the drill bit, not affecting the drilling operation, not interfering with the surrounding human body parts, and not affecting the operation of other devices and the overall aesthetics of the instrument, the reinforcing rib 60 can be arbitrarily set.

[0074] As an example, take Figure 8 and Figure 9 as examples. Connect the second end edge of the reinforcing rib 60 (referring to the edge of the end of the reinforcing rib 60 close to the bearing part 10) to the first side surface 11 of the bearing part 10, and connect one side edge of the reinforcing rib 60 to the outer side of the tube wall of the guiding tube 20 to ensure the stiffness of the guiding tube 20. Take Figure 10 and Figure 11 as examples. Connect the reinforcing rib 60 between two adjacent guiding tubes 20. The two side edges of the reinforcing rib 60 are respectively connected to the outer sides of the tube walls of these two guiding tubes 20. The first end edge of the reinforcing rib 60 (referring to the edge of the end of the reinforcing rib 60 far from the bearing part 10) can be flush or not flush with the first end of the guiding tube 20 (referring to the end of the guiding tube 20 far from the bearing part 10); the second end edge of the reinforcing rib 60 can be connected or not connected to the first side surface 11 of the bearing part 10. Take Figure 12 and Figure 13 as examples. Multiple reinforcing ribs 60 can be arranged between two adjacent guiding tubes 20 at the same time. The two side edges of each reinforcing rib 60 are respectively connected to the outer sides of the tube walls of these two guiding tubes 20. Depending on the position, the first end edge of the uppermost reinforcing rib 60 can be flush or not flush with the first end of the guiding tube 20, and the second end edge of the lowermost reinforcing rib 60 can be connected or not connected to the first side surface 11 of the bearing part 10. As shown in Figure 1 、 Figure 3 、 Figure 4 , the reinforcing rib 60 and the guiding tube 20 it is connected to can have the same angle, that is, the angles between the reinforcing rib 60, the guiding tube 20 and the first side surface 11 of the bearing part 10 are the same, but this is not a limitation on the angle of the reinforcing rib 60. Take Figure 4 as an example. Depending on the layout position between the guiding tubes 20, in some examples, one side edge of the reinforcing rib 60 is connected to the guiding tube 20 to ensure the stiffness of the guiding tube 20, and the other side edge of the reinforcing rib 60 can be connected to another reinforcing rib 60 arranged between other guiding tubes 20. In addition, for example, the shape, height, thickness of the reinforcing rib 60, the spacing between adjacent reinforcing ribs 60, etc. can all be set according to the actual application requirements and the layout space on the bearing part 10, and the present invention does not limit this.

[0075] Such as Figures 1 to 5As shown, there may be one or more mounting posts 40 on the bearing part 10, and the number is greater than or equal to the number of the guide tubes 20. The mounting posts 40 can be divided into two types: The number of the first type of mounting posts 40 is the same as that of the guide tubes 20, corresponding to the guide tubes 20 one by one and internally communicating; the first type of mounting posts 40 is not only used to connect the guide to the prosthesis trial mold or the osteotomy plate, but also allows a drill bit to pass through based on the guide holes 30 extending into it; that is, the guide holes 30 axially opened along the guide tubes 20 further penetrate into the first type of mounting posts 40. The inlet end of the guide hole 30 corresponds to the first end of the guide tube 20 (referring to the end of the guide tube 20 away from the bearing part 10), and the outlet end of the guide hole 30 corresponds to the second end of the mounting post 40 (referring to the end of the mounting post 40 away from the bearing part 10), so that the outlet end of the guide hole 30 (the opening corresponding to the second end of the mounting post 40) faces the target area to be drilled on the human bone.

[0076] The second type of mounting posts 40 is optional and can be provided or omitted according to needs; the second type of mounting posts 40 does not need to be correspondingly arranged with the guide tubes 20, nor does it need to be opened inside, and is only used to connect the guide to the prosthesis trial mold or the osteotomy plate; if the area of the bearing part 10 itself is small, or when the guide can be reliably connected to the prosthesis trial mold or the osteotomy plate through the first type of mounting posts 40, the second type of mounting posts 40 can be omitted.

[0077] Any one of the mounting posts 40 can cooperate with the mounting holes 73 ( Figure 15 、 Figure 17 ) on the prosthesis trial mold or the osteotomy plate, and be inserted into the corresponding mounting holes 73 to connect the guide to the prosthesis trial mold or the osteotomy plate as a whole, ensuring the relative position of the guide to the prosthesis trial mold or the osteotomy plate. When the prosthesis trial mold or the osteotomy plate is installed on the human bone, the guide holes 30 on the guide provide precise guidance for the drill bit.

[0078] Such as Figures 1 to 5 、 Figure 15 、 Figure 17As shown, the column body of the mounting post 40 mainly considers the fit with the mounting hole 73 (for example, an interference fit between the two). The set angle of the column body has no necessary relation with the angle of the guiding tube 20 and the angle of the guiding hole 30. The included angle between the column body of the mounting post 40 and the second side surface 12 of the bearing part 10 can be the same or different from the included angle between the guiding tube 20 and the first side surface 11 of the bearing part 10. Suppose a certain drilling needs to be inclined, then the guiding hole 30 set for this purpose is inclined, and the guiding tube 20 that matches the guiding hole 30 therein is also inclined (so that there is a specified first included angle between the guiding tube 20 and the first side surface 11 of the bearing part 10). At this time, the column body of the first type of mounting post 40 corresponding to the guiding tube 20 can have a first included angle with the second side surface 12 of the bearing part 10 so that the column body and the guiding tube 20 are inclined at the same angle, or the column body can also have a second included angle with the second side surface 12 of the bearing part 10, and the angles of the first included angle and the second included angle are different (such as Figure 1 , Figure 17 In, the column body of the mounting post 40 itself can be perpendicular to the second side surface 12 of the bearing part 10, and is different from the angle of the inclined guiding tube 20 or guiding hole 30); however, regardless of whether the column body itself is inclined and whether the angle is the same as that of the guiding tube 20, each guiding hole 30 needs to be set perpendicular or inclined to the bearing part 10 according to the drilling requirements, and the angle of the guiding hole 30 itself remains unchanged from the inlet end to the outlet end ( Figure 17 ), and the angles of each guiding tube 20 within the corresponding guiding tube 20, within the mounting post 40, and within the part of the bearing part 10 between the guiding tube 20 and the mounting post 40 are the same. The diameter of each guiding hole 30 also remains unchanged from the inlet end to the outlet end.

[0079] Such as Figure 1 , Figure 4 , Figure 6 , Figure 7 As shown, in some examples, an elastic ring is provided between the outer wall of the column body of the mounting post 40 and the inner wall of the mounting hole 73 of the prosthesis trial mold or osteotomy plate; the elastic ring can be an O-shaped elastic ring 51 ( Figure 1 , Figure 6 ) or a C-shaped elastic ring 52 ( Figure 4 , Figure 7 ), for example, made of silica gel, sleeved on the outer wall of the column body of the mounting post 40 or sleeved in a groove opened on the outer wall of the column body; the elastic ring can appropriately compensate for the dimensional difference between the column body and the mounting hole 73 and increase the friction force, making it easier for the mounting post 40 and the mounting hole 73 to achieve an interference fit, preventing the column body from loosening or falling off, and realizing the reliable connection between the guide and the prosthesis trial mold or osteotomy plate; it can also absorb part of the vibration energy during drilling through the elastic ring, avoiding the displacement of the prosthesis trial mold or osteotomy plate on the human bone due to the influence of vibration.

[0080] Such asFigure 15 , Figure 17 As shown in Figure 17 , the prosthesis trial mold or osteotomy plate is provided with a bone contact surface 74 that can contact human bone; the bone contact surface 74 has a characteristic structure complementary to the bone interface 90 of the target area, so as to fit better with the bone interface 90. The prosthesis trial mold or osteotomy plate is also provided with a surface (referred to as the support surface 75) for supporting the bearing part 10, and the support surface 75 can be any exposed surface on the prosthesis trial mold or osteotomy plate other than the bone contact surface 74. After the column body of the mounting post 40 extends from the second side surface 12 of the bearing part 10 and is inserted into the mounting hole 73 of the prosthesis trial mold or osteotomy plate, the support surface 75 of the prosthesis trial mold or osteotomy plate is in close contact with the second side surface 12 of the bearing part 10, playing a role in stabilizing the guide; at this time, the outlet end of the guide hole 30 (i.e., the opening at the second end of the mounting post 40) is facing the position to be drilled on the bone interface 90.

[0081] Exemplarily, two opposite surfaces on the prosthesis trial mold or osteotomy plate are respectively used as the support surface 75 and the bone contact surface 74, but this is not a limitation on the positions of these two surfaces. The column body height of the mounting post 40 matches the depth of the mounting hole 73, so that the end surface of the second end of the mounting post 40 matches the surrounding bone contact surface 74 (for example, they are flush), and the two together form a contact surface complementary to the characteristic structure of the bone interface 90, so as to fit better with the bone interface 90. In different examples, the bone interface 90 where the prosthesis trial mold or osteotomy plate is installed and the guide is required for drilling guidance can have the original surface morphology of the bone at this place, or can be the surface morphology after osteotomy or other surgical operations have been performed (such as a plane after osteotomy).

[0082] The guide can be made by CNC machining (computer numerical control precision machining) to ensure the machining accuracy of each part on the guide, especially to ensure that the machined guide hole 30 meets the drilling requirements for installing the prosthesis column 83. An exemplary guide is made of stainless steel. For example, first use stainless steel 17-4 with an initial hardness of approximately HRC30 to machine the entire guide; then heat-treat the entire guide through H900 to increase the hardness to HRC40-50, thereby increasing the hardness of the guide, avoiding the problem of deformation caused by self-stress and inaccurate guidance. This also improves the strength and stiffness of the guide, enabling it to better withstand the interaction force between the drill bit and human bone during drilling, avoiding surgical accidents caused by deformation or fracture of the guide, and improving surgical safety; moreover, the guide has a better effect of resisting drill bit friction or wear, avoiding problems such as aperture changes caused by excessive friction and wear; even in some cases where the guide needs to be disinfected and reused, the high-hardness guide can maintain the pre-set drilling guidance accuracy, extend the service life, and help reduce costs.

[0083] Some specific embodiments of the guide are schematically described as follows. As Figure 1 , Figure 2 shown in the first embodiment of the guide, the projection shape of the bearing portion 10 is generally a rounded rectangle; two guide tubes 20 are provided on the first side of the bearing portion 10, and these two guide tubes 20 are inclined with respect to the first side surface 11 of the bearing portion 10, and the inclination directions and angles of both are the same (assuming that the included angle a between the guide tube 20 and the first side surface 11 in this example is < 90°). The reinforcing rib 60 connected between the two guide tubes 20 is generally in the shape of a rectangular plate, and has the same inclination direction and angle as these two guide tubes 20. Two mounting posts 40 are provided on the second side surface 12 of the bearing portion 10, corresponding to the two guide tubes 20 respectively; the column body of each mounting post 40 itself is perpendicular to the second side surface 12 of the bearing portion 10, so the included angles between the mounting post 40, the guide tube 20 and the bearing portion 10 are different; however, the inside of the mounting post 40 and the inside of the corresponding guide tube 20 are interconnected, and the guide hole 30 axially opened along the guide tube 20 is consistent with the inclination direction and angle of the guide tube 20 where it is located, and when the guide hole 30 further extends into the bearing portion 10 and the mounting post 40, it still maintains the same inclination direction and angle unchanged. In this example, an O-shaped elastic ring 51 is sleeved outside the pipe wall of the mounting post 40, which can be replaced with a C-shaped or other-shaped elastic ring, or the elastic ring can be omitted.

[0084] As Figure 3 shown in the second embodiment of the guide, the main difference from the aforementioned first embodiment is that the two guide tubes 20 and the reinforcing rib 60 therebetween in this example are both vertically arranged with respect to the first side surface 11 of the bearing portion 10 (assuming that the included angle b between the guide tube 20 and the first side surface 11 in this example is = 90°). The two mounting posts 40 corresponding to the two guide tubes 20 are perpendicular to the second side surface 12 of the bearing portion 10, then the guide hole 30 penetrating from the guide tube 20 to the inside of the mounting post 40 is also perpendicular to the bearing portion 10. Compared with the first embodiment, after the guide tubes 20 and the mounting posts 40 are arranged in this example, the areas reserved on the first side surface 11 and the second side surface 12 of the bearing portion 10 around the guide tubes 20 and the mounting posts 40 are smaller, and the overall structure of the guide is more compact. The elastic ring on the mounting post 40 is not shown in this example; an O-shaped or C-shaped or other-shaped elastic ring can be further provided for it according to needs.

[0085] As Figure 4 , Figure 5In the third embodiment shown, the projected shape of the bearing part 10 is generally a rounded triangle; three guide tubes 20 are distributed on the first side of the bearing part 10, and two of the guide tubes 20 are inclined with respect to the first side surface 11 of the bearing part 10, and the inclination directions and angles of the two are the same (assuming that the included angle c1 between the inclined guide tube 20 and the first side surface 11 in this example is < 90°); a first reinforcing rib 60 is connected between the two inclined guide tubes 20, which is generally in the shape of a rectangular plate; the first reinforcing rib 60 has the same inclination direction and angle as the two guide tubes 20. At the same time, the third guide tube 20 is perpendicular to the first side surface 11 of the bearing part 10 (assuming that the included angle c2 between the third perpendicular guide tube 20 and the first side surface 11 in this example is = 90°), and the second reinforcing rib 60 connected to this perpendicular guide tube 20 is generally in the shape of a trapezoidal plate; the length of the first end edge (the edge far from the bearing part 10) of the trapezoid is long, the second end edge is short and is connected to the first side surface 11 of the bearing part 10, the vertical side of the trapezoid is connected to the outer wall of the perpendicular guide tube 20, and the inclined side is connected to the first reinforcing rib 60 between the two inclined guide tubes 20. In this example, the heights of the third perpendicular guide tube 20 and the second reinforcing rib 60 connected to it are both lower than the heights of the other two inclined guide tubes 20 and the first reinforcing rib 60 connected to them.

[0086] In the third embodiment, three mounting posts 40 are provided on the second side surface 12 of the bearing part 10, corresponding to the three guide tubes 20 respectively; the column body of each mounting post 40 is perpendicular to the second side surface 12 of the bearing part 10. Therefore, the included angles between two of the mounting posts 40 and the two corresponding inclined guide tubes 20 with respect to the bearing part 10 are different, while the included angle between the other mounting post 40 and the corresponding third perpendicular guide tube 20 with respect to the bearing part 10 is the same; however, the interiors of each mounting post 40 and the corresponding guide tube 20 communicate with each other, and the guide holes 30 axially opened in each guide tube 20 are consistent with the angle of the guide tube 20 (that is, two of the guide holes 30 are inclined and the third guide hole 30 is perpendicular), and when the respective guide holes 30 further extend into the bearing part 10 and the mounting posts 40, they still maintain their respective same angles in the guide tubes 20 unchanged. In this example, a C-shaped elastic ring 52 is sleeved outside the tube wall of each mounting post 40, which can be replaced with an O-shaped or other shaped elastic ring, or the elastic ring can be omitted.

[0087] It can be understood that the guides provided in the above first to third embodiments are schematic and do not limit the structure of the guide. Each component of the guide can be customized according to actual application needs, such as but not limited to adjusting the shape of the bearing portion 10, the number of guide tubes 20 or mounting posts 40, the position or angle of the guide tube 20 on the bearing portion 10, the relative position, relative angle or height relationship between tubes, the position or angle of the mounting post 40 on the bearing portion 10, the relative position or relative angle between posts, the number, shape, position on the bearing portion 10 or the position or height relationship of connection with the guide tube 20 of the reinforcing rib 60, and so on.

[0088] Some specific embodiments for providing drilling guidance for the assembly of the guide and the prosthesis trial mold and installing the prosthesis after drilling are schematically described below. The applicable prosthesis can be any prosthesis with posts 83, and its posts 83 need to be installed into the holes drilled in the human bone (after the drill bit is precisely guided by the guide). Preferably, it is a columnar biological prosthesis, and there is a certain interference fit amount (interference fit between the two) between its posts 83 and the drilled holes, which can stimulate bone ingrowth, achieve long-term effective fixation of the prosthesis, and reduce the risk of revision due to prosthesis loosening.

[0089] Figure 14 、 Figure 15 In the embodiment of, taking the setting of the ankle joint tibial plateau prosthesis 81 and its trial mold 71 as an example for description, Figure 14 is a schematic diagram when the prosthesis 81 is installed in the target area on the tibia, Figure 15 is a schematic diagram when a guide cooperates with the ankle joint tibial plateau prosthesis trial mold 71 to simulate installation in the target area on the tibia.

[0090] The external shapes of the ankle joint tibial plateau prosthesis 81 and its trial mold 71 are very similar. The bone contact surface 84 of the prosthesis 81 is the same as the bone contact surface 74 of its trial mold 71, and both match the bone interface of the target area on the tibia so that the bone contact surface 84 and the bone contact surface 74 can better fit the bone interface. However, since drilling has not been immediately formed when simulating installation on the bone interface through the trial mold 71, the trial mold 71 does not include the two posts 83 provided on the ankle joint tibial plateau prosthesis 81, but two mounting holes 73 are formed at the positions corresponding to the two posts 83 of the prosthesis 81 on the trial mold 71, so that the two mounting posts 40 on the guide can be correspondingly inserted into these two mounting holes 73 to realize the assembly of the guide and the trial mold 71.

[0091] In this example, one side of the trial mold 71 that does not contact the bone interface has a groove, such as a trapezoidal groove; the bearing part 10 of the guide has a matching trapezoidal plate body that can be inserted into the trapezoidal groove of the trial mold 71. The support surface on the trial mold 71 corresponds to the bottom of the trapezoidal groove and fits with the second side surface 12 of the bearing part 10, realizing a stable connection between the guide and the trial mold 71; the groove provided on the trial mold 71 is substantially the same as the groove provided on the side of the corresponding prosthesis 81 that does not contact the bone interface.

[0092] In this example, the guide has two inclined guide tubes 20 with the same length, the same inclination direction and inclination angle relative to the bearing part 10; a guide hole 30 is axially opened in the guide tube 20 and extends into the mounting post 40, and has the same inclination angle as the guide tube 20 where the guide hole 30 is located. It is necessary to wait for the trial mold 71 to complete the simulated installation and determine a relatively ideal installation position on the bone interface, and then guide the drill through the guide hole 30 of the guide to drill two holes at the positions on the bone interface facing the outlet ends of the two guide holes 30 (in this example, two inclined holes arranged inside and outside the bone interface can be obtained); subsequently, after removing the combined structure of the ankle joint tibial plateau prosthesis trial mold 71 and the guide, when installing the ankle joint tibial plateau prosthesis 81 on the tibia, the two columns 83 of the prosthesis 81 can be inserted into these two drilled holes to ensure that the prosthesis 81 can be accurately and firmly installed on the tibia.

[0093] Figure 16 、 Figure 17 In the embodiment of, taking the setting of the unicondylar tibial plateau prosthesis 82 and its trial mold 72 as an example for illustration, Figure 16 is a cross-sectional view when the prosthesis 82 is installed on the target area of the tibia, Figure 17 is a cross-sectional view when another guide cooperates with the unicondylar tibial plateau prosthesis trial mold 72 for simulated installation on the target area of the tibia. Before applying the unicondylar tibial plateau prosthesis 82 described in this embodiment, only one-sided intercompartmental joint needs to be resected through unicondylar replacement surgery, with more bone mass preservation and less trauma. However, there will be problems such as a smaller drilled joint surface and more restricted peripheral operating space. For this reason, another structure of the guide that can adapt to this situation is provided.

[0094] The external morphology of the unicondylar tibial plateau prosthesis 82 is very similar to that of its trial mold 72. The bone contact surface 84 of the prosthesis 82 is consistent with the bone contact surface 74 of its trial mold 72, and both match the bone interface 90 of the target area on the tibia. For example, the bone interface 90 is a flat surface after osteotomy, and the bone contact surface 84 of the prosthesis 82 and the bone contact surface 74 of the trial mold 72 are corresponding flat surfaces. The trial mold 72 does not include the two columns 83 of the unicondylar tibial plateau prosthesis 82, but forms two mounting holes 73 at the positions corresponding to the two columns 83 of the prosthesis 82 on the trial mold 72 for the two mounting posts 40 on the guide to be inserted, so as to assemble the guide with the trial mold 72. At this time, the second side surface 12 of the bearing part 10 fits with the support surface 75 on the trial mold 72, making the installation of the guide more stable. In this example, the periphery of the support surface 75 of the trial mold 72 has a fence, and the bearing part 10 will not exceed the range defined by the fence. The support surface 75 and the fence form a groove, which is similar to the groove on the side of the corresponding prosthesis 82 that does not contact the bone interface 90 (on the prosthesis 82, according to application requirements, there is an additional fold on the inner side of the fence of the groove).

[0095] In this example, the guide has two inclined guide tubes 20 with the same inclination direction and inclination angle relative to the bearing part 10. However, considering the relatively small operating space around, the lengths of the two tubes are set differently, and the lengths of the two guide holes 30 respectively opened along the axial directions of the two tubes are also different. These two guide holes 30 maintain the same inclination angle and extend into the two mounting posts 40 vertically arranged with respect to the bearing part 10, and then penetrate to the second ends of the two mounting posts 40. In this example, the outlet ends of the two guide holes 30 are flush with the second ends of the mounting posts 40 and the bone contact surface 74 of the trial mold 72. Due to the different lengths, the heights of the inlet ends of the two guide holes 30 are different, but they deviate in the same direction ( Figure 17 the upper right of the shown drawing surface), improving the operability of drilling in a limited space. After the trial mold 72 completes the simulated installation and determines the relatively ideal installation position on the bone interface 90, the drill bit is then guided through the guide holes 30, and two holes are drilled at the positions on the bone interface 90 directly opposite to the outlet ends of the two guide holes 30 (in this example, two inclined holes arranged front and back on the bone interface 90 can be obtained, and the depths of the two holes are the same). Subsequently, after removing the combined structure of the unicondylar tibial plateau prosthesis trial mold 72 and the guide, when installing the unicondylar tibial plateau prosthesis 82 on the tibia, the two columns 83 of the prosthesis 82 can be inserted into these two drilled holes, ensuring that the prosthesis 82 can be accurately and stably installed on the tibia.

[0096] It can be understood that the prostheses, trial molds, and guides provided in the above embodiments of this article are all illustrative, not restrictive of the structures of these devices, etc., nor of the usage scenarios of the guide described in the present invention.

[0097] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be recognized that the above description should not be considered as a limitation of the present invention. After those skilled in the art have read the above content, various modifications and alternatives to the present invention will be obvious. Therefore, the protection scope of the present invention should be defined by the appended claims.

Claims

1. A guide, characterized in that: Include: a load-bearing portion having a first side and a second side opposite to each other; A guide tube, disposed on a first side of the bearing portion; A mounting post, disposed on the second side of the bearing portion; the mounting post is used to connect the guide to a prosthesis trial mold or an osteotomy plate; The guide tube and the corresponding mounting column are provided with a through guide hole for guiding the drill bit passing through the guide hole.

2. The guide device according to claim 1, characterized in that: The guide hole is opened along the axial direction of the guide tube in which it is located, and extends into the mounting column corresponding to the guide tube; the inlet end of the guide hole corresponds to the opening of the end of the guide tube away from the bearing part, and the outlet end of the guide hole corresponds to the opening of the end of the mounting column away from the bearing part, so that the outlet end of the guide hole faces the target area to be drilled on the human bone; A drill bit guided by the guide hole is used to drill a target area on the human bone facing the outlet end of the guide hole, so that when the prosthesis is installed on the human bone, the column on the prosthesis can be correspondingly inserted into the drilled hole; The angle between the guide tube and the first side surface of the bearing part is the same as or different from the angle between the column of the mounting column and the second side surface of the bearing part; the angle between the guide hole and the bearing part remains unchanged from the inlet end to the outlet end; The bearing portion is provided with one or more guide tubes; when there are multiple guide tubes, the angles between these guide tubes and the first side surface of the bearing portion are the same or different; when there are multiple guide tubes, these guide tubes have the same or different lengths.

3. The guide device according to claim 1, characterized in that: The guide meets any of the following requirements: The guide device is provided with two guide tubes, which are respectively perpendicular to the first side surface of the bearing portion, or respectively inclined to the first side surface of the bearing portion and the inclination angles are the same or different, or one is perpendicular to the first side surface of the bearing portion and the other is inclined to the first side surface of the bearing portion; Alternatively, the guide has three guide tubes, which are respectively perpendicular to the first side surface of the load-bearing portion, or respectively inclined to the first side surface of the load-bearing portion and the inclination angles are the same or different, or two of the guide tubes are perpendicular to the first side surface of the load-bearing portion and the other is inclined to the first side surface of the load-bearing portion, or one of the guide tubes is perpendicular to the first side surface of the load-bearing portion and the other two guide tubes are inclined to the first side surface of the load-bearing portion and the inclination angles are the same or different.

4. The guide device according to claim 1, characterized in that: The guide meets at least one of the following requirements: The diameter of the guide hole is within 0.2 mm larger than the diameter of the drill bit; The wall thickness of the guide tube is 1 to 1.5 mm; The guide hole has a length that is long enough so that when the drill bit is drilling, a part of the drill bit or a part of the connecting rod connected to the drill bit is located in the guide hole; The relationship between the diameter d of the guide hole and the guide length H is H / d≥2.5; The guide is stainless steel; the guide is heat treated after machining to increase hardness.

5. The guide device according to claim 1, characterized in that: A reinforcing rib connected to the guide tube is provided on the first side of the bearing portion; One side of the reinforcing rib is connected to the outer side of the wall of a guide tube; the other side of the reinforcing rib is connected to the outer side of the wall of another guide tube or to another reinforcing rib; The edge of the reinforcing rib close to one end of the load-bearing portion is connected to the first side surface of the load-bearing portion or is separated from the first side surface of the load-bearing portion; The angle between the reinforcing rib and the first side surface of the bearing portion is the same as or different from the angle between the guide tube and the first side surface of the bearing portion.

6. The guide device according to claim 1, characterized in that: The column body of the mounting column matches with the mounting hole on the prosthesis trial mold or the osteotomy plate and is inserted into the corresponding mounting hole to connect the guide with the prosthesis trial mold or the osteotomy plate into a whole; An elastic ring is provided between the outer wall of the mounting column and the inner wall of the mounting hole, or the elastic ring is omitted; The number of the mounting columns is greater than or equal to the number of the guide tubes; The mounting column at least includes a first mounting column; the first mounting column corresponds to the guide tube one by one and is internally connected to form the guide hole; When the number of the mounting columns is greater than the number of the guide tubes, a second mounting column is further included; the second mounting column does not correspond to the guide tube, and no guide hole is provided inside the second mounting column.

7. The guide device according to claim 1 or 2, characterized in that: The prosthesis trial mold or osteotomy plate is provided with a bone contact surface that can contact the bone interface of human bones; the bone interface has the original surface morphology of human bones or has a surface morphology that has been processed by surgery; When the column body of the mounting column is inserted into the mounting hole on the prosthesis trial mold or the osteotomy plate, the end face of the mounting column away from the bearing portion cooperates with the bone contact surface of the prosthesis trial mold or the osteotomy plate located around the end face to form a characteristic structure that can complement and fit the bone interface; The prosthesis trial mold or osteotomy plate is also provided with a supporting surface for supporting the load-bearing part, and the supporting surface is any exposed surface of the prosthesis trial mold or osteotomy plate except the bone contact surface; when the column body of the mounting column extends from the second side surface of the load-bearing part and is inserted into the mounting hole, the supporting surface of the prosthesis trial mold or osteotomy plate is tightly fitted with the second side surface of the load-bearing part.

8. The guide device according to claim 2, characterized in that: A prosthesis trial mold or osteotomy plate of one or more specifications is configured, and a plurality of guides with different guide hole opening conditions are configured; a prosthesis trial mold or osteotomy plate that meets the prosthesis adaptation or osteotomy requirements of the current bone interface is connected to one of the guides to meet the requirements of at least part of the drilling target of the target area; The guide holes are opened differently, including at least one of the following differences: the diameter of the guide holes, the position of the guide holes, the angle of the guide holes, the relative positions of different guide holes, and the relative angles of different guide holes; The guide adapts to the requirements of at least a portion of the drilling target of the target area, including: A single guide that can be connected to a prosthetic trial mold or an osteotomy plate is configured, and all guide holes corresponding to all drilling targets in the target area are formed on the single guide; Alternatively, a plurality of guides that can be connected to the prosthetic trial mold or the osteotomy plate in sequence are configured, and guide holes corresponding to all drilling targets in the target area are dispersedly formed on the plurality of guides.

9. The guide device according to claim 2, characterized in that: The prosthesis comprises a column-type bio-type prosthesis; The column of the column-type bioprosthesis is interference-fitted with the drilled hole.

10. The guide device according to claim 2, 8 or 9, characterized in that: The prosthesis is an ankle joint tibial plateau prosthesis; the prosthesis trial mold is an ankle joint tibial plateau prosthesis trial mold; the osteotomy plate is an osteotomy plate used for performing osteotomy on the proximal tibia in total knee replacement surgery; Alternatively, the prosthesis is a unicompartmental tibial plateau prosthesis; the prosthesis trial mold is a unicompartmental tibial plateau prosthesis trial mold; and the osteotomy plate is an osteotomy plate used for performing osteotomy on the medial or lateral side of the proximal tibia in unicompartmental replacement surgery.

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