Osteotomy guide plate and preparation method thereof

Abstract

The invention discloses an osteotomy guide plate and a preparation method thereof. The osteotomy guide plate comprises a substrate, an osteotomy guide standardized part, a guide plate retention hole, a nail hole and a drainage channel; wherein the guide plate retention hole is distributed on the surface of the substrate; the outer end side of the nail hole is integrally formed with a standardized sleeve, and a detachably connected protective inner sleeve standardized part is provided within the standardized sleeve. The preparation method comprises parameter design and model printing, wherein an innovative nail hole positioning method is used in the parameter design. The invention is suitable for the osteotomy operation of different parts, with the advantages of convenient production, high precision and long service life; the preparation method improves the accuracy of opening a hole on the osteotomy guide plate.

Claims

1. A computer-implemented method for preparing an osteotomy guide plate, comprising: creating an osteotomy guide part outline data comprising an osteotomy guide through groove outline data, wherein the osteotomy guide through groove outline data is consisting essentially of a hollowed-out chamfered cuboid; creating a sleeve outline data; creating a virtual restoration model comprising a virtual postoperative bone model and a postoperative bone graft model; obtaining a restoration model comprising 3D printing the virtual restoration model; forming a metal bone plate having a mounting hole onto the restoration model; forming a nail hole site on the restoration model along the mounting hole; three-dimensional scanning the restoration model with the nail hole site; creating a virtual nail hole according to the nail hole site, wherein the virtual nail hole comprises a cylinder and intersects with an edge of the virtual postoperative bone model and an edge of the postoperative bone graft model; creating a model of a bone to be cut; obtaining a virtual substrate coverage area and an osteotomy line position in the model of the bone to be cut; generating a virtual substrate corresponding to the virtual substrate coverage area; selecting one of the osteotomy guide part outline data which comprises one of the osteotomy guide through groove outline data coinciding with the osteotomy line; generating a virtual osteotomy guide part comprising a virtual osteotomy guide through groove, according to the selected one osteotomy guide part outline data; creating a virtual sleeve corresponding to the virtual nail hole on the virtual osteotomy guide plate according to the sleeve outline data; and three-dimensional printing the virtual substrate, the virtual osteotomy guide part and the virtual sleeve, for obtaining the osteotomy guide plate comprising a substrate, osteotomy guide part and a sleeve.

2. The method according to claim 1, wherein the bone to be cut is a mandible.

3. The method according to claim 1, wherein the bone to be cut is a fibula.

4. The method according to claim 1, wherein a surface of the substrate comprises a convex mark.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the figures required for describing the embodiments or the prior art will be briefly described below. Obviously, the figures in the following description are only certain embodiments of the present invention, and other figures can be obtained based on these figures by those of ordinary skill in the art without any creative work.

(2) FIG. 1 is a schematic structural view of a mandibular osteotomy guide plate according to embodiment 1 of the present invention;

(3) FIG. 2 is a perspective view of an embodiment of the present invention;

(4) FIG. 3 is a schematic structural view of an embodiment of the present invention;

(5) FIG. 4 is a schematic structural view of a protective inner sleeve standardized part according to an embodiment of the present invention;

(6) FIG. 5 is a schematic structural view of a mandibular osteotomy guide plate according to embodiment 2 of the present invention;

(7) FIG. 6 is a schematic structural view of the structure of a metal bone plate used in the present invention.

(8) FIG. 7 is a flow chart of a method for preparing an osteotomy guide plate according to an embodiment of the present application.

DESCRIPTION OF THE REFERENCE NUMERALS

(9) 1. Substrate; 2. Osteotomy guide standardized part; 21. Osteotomy guide through groove; 3. Guide plate retention hole; 4. Nail hole; 41. Standardized sleeve; 5. Bone in the operation area; 6. Protective inner sleeve standardized part; 61. Prismoid; 7. Drainage channel; 8. Convex mark; 9. Metal bone plate; 91. Mounting hole.

DETAILED DESCRIPTION OF THE INVENTION

(10) The technical solutions of the present invention will be clearly and completely described in the following with reference to the accompanying figures. It is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

(11) In the description of the present invention, it is to be noted that the orientation or positional relationship indicated by terms “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer”, etc. is based on the orientation or positional relationship shown in the figures, and is merely for a convenient and simplified description of the invention, rather than indicating or implying that the device or component of interest is in a specific orientation or constructed or operated in a specific orientation, and is therefore not to be construed as limiting the invention. In addition, the terms “first,” “second,” and “third” are used merely for description and are not to be construed as indicating or implying relative importance.

(12) In the description of the present invention, it should be noted that the terms “installed”, “connected”, and “coupled” are to be understood broadly, such as fixed or detachably connected, or integrated coupled, unless otherwise explicitly defined and limited. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, or the communication of the inner parts between two components. The specific meaning of the above terms in the present invention can be understood depending on specific cases by those skilled in the art.

(13) In addition, the technical features involved in different embodiments of the present invention described below may be combined with each other as long as they do not constitute a conflict with each other.

Embodiment 1

(14) As shown in FIG. 1, the present invention provides a mandibular osteotomy guide plate, comprising a substrate 1 and an osteotomy guide standardized part 2, a guide plate retention hole 3 and a nail hole 4 respectively disposed on the substrate 1; wherein the substrate 1 is adapted to the shape of the bone (mandible) 5 in the operation area; the osteotomy guide standardized part 2 is provided with an osteotomy guide through groove 21, the osteotomy guide standardized part 2 is provided in at least one, and the osteotomy guide through groove 21 of each of the osteotomy guide standardized part 2 corresponds to the osteotomy line in the operation area; the guide plate retention hole 3 is distributed on the surface of the substrate 1 for matching with a screw to fix the substrate 1 on the bone 5 in the operation area; the outer end side of the nail hole 4 is integrally formed with a standardized sleeve 41, and a detachably connected protective inner sleeve standardized part 6 is provided within the standardized sleeve 41, and the protective inner sleeve standardized part 6 is used for guiding and positioning the direction of perforating for a drilling device.

(15) In the osteotomy guide provided by the present invention, except for the substrate 1, the other components are standardized parts and are designed for different patients. It can be prepared simply by setting the substrate 1 according to the shape of the patient's mandible and assembling several other specified types of standardized parts compatible with the model on the substrate 1. The standardized parts involved in the invention can be mass-produced, which avoids firstly one-to-one production of personalized substrates, and then the design of personalized osteotomy guides and the like according to the substrate 1 in the prior art, thereby substantially improving the efficiency in producing the osteotomy guide plate. Moreover, since most of the components in the present invention are standardized parts, the standardized parts are free of significant layering when performing the 3D printing. In particular, the substrates of the cuboid standardized parts are kept from high risk of damage caused by uneven stress transfer when subjecting an to external force.

(16) The osteotomy guide standardized part 2 in the present invention is a plate-like structure, and the osteotomy guide through groove 21 is provided on the sidewall of the plate-like structure. In addition, the depth of the osteotomy guide through groove 21 in the width direction of the structure is greater than the thickness of the substrate 1, whereby ensuring good guidance to the surgical scalpel from the osteotomy guide through groove 21. Of course, each substrate 1 may be provided with a plurality of osteotomy guide standardized part 2 as required by the actual osteotomy line. The osteotomy guide through groove 21 on each osteotomy guide standardized part 2 corresponds to the osteotomy line. The adjacent two osteotomy guide standardized parts 21 may also be arranged crosswise. At the intersection, the two osteotomy guide through grooves 21 involved are in communication, to facilitate the surgeon to cut from different angles.

(17) As shown in FIG. 1, the guide plate retention hole 3 and the nail hole 4 are respectively disposed on the substrate of the present invention, instead of being used in combination as in the conventional osteotomy guide plate. In the present invention, the guide plate retention hole 3 is matched with a screw for fixing the substrate 1 to the bone 5 in the operation area. As shown in FIG. 6, the nail hole 4 corresponds to the mounting hole 91 on the metal bone plate 9 for guiding and positioning the direction of perforating for a drilling device. Therefore, each hole site performs its own duty, which greatly reduces the damage to the substrate 1 around the nail hole 4, and improves the yield of the osteotomy guide plate during the preparation.

(18) In addition, as shown in FIG. 3, the present invention also integrally forms a standardized sleeve 41 on the outer end side of the nail hole 4. The standardized sleeve 41 is a standardized part suitable for each nail hole 4 on the substrate 1. This standardized structure can avoid breakage of the substrate 1 caused by the conventional nail hole 4. In addition, a detachably connected protective inner sleeve standardized part 6 is provided within the standardized sleeve 41. The standardized sleeve 41 and the protective inner sleeve standardized part 6 form an assembly. The two are locked to each other, which can greatly enhance the strength of the assembly. When designing such a structure, the engineer only needs to match the standardized part imported when designing the nail hole 4 of each substrate 1. It substantially improves the design efficiency of the engineer. In addition, by providing the standardized sleeve 41 and the protective inner sleeve standardized part 6, it avoids excessive damage to the substrate 1 even if the drilling tool needs to be guided through the drill hole multiple times. It further improves the yield of the osteotomy guide plate. In the present embodiment, at least one groove (not shown) is formed on the inner wall of the standardized sleeve 41. As shown in FIG. 4, the outer wall of the protective inner sleeve standardized part 6 is provided with a prismoid 61 adapted to the groove, and the protective inner sleeve standardized part 6 is locked in the groove of the standardized sleeve 41 by the prismoid 61. Of course, the inner wall of the standardized sleeve 41 can also be provided with a prismoid. In this condition, the outer wall of the inner sleeve standardized part 6 is provided with a matching groove to realize the locking after assembly. No matter how the inner sleeve standardized part 6 is locked, it has a hardness greater than that of the standardized sleeve 41. For example, the standardized sleeve 41 is made of photosensitive resin, and the inner sleeve standardized part 6 is made of stainless steel or titanium alloy.

(19) As an optional embodiment, as shown in FIG. 2, the present invention also provides a drainage channel 7 in the osteotomy guide plate, and compared to the practice of perforating a drainage hole near the nail hole 4 of the osteotomy guide plate, the drainage channel 7 of the present invention has the following features. The strip-shaped lumen of the drainage channel 7 is distributed between the guide plate retention hole 3 and the nail hole 4. The guide plate retention hole 3 and the nail hole 4 are communicated with the outer ambient. The channel has higher drainage efficiency with respect to the hole. Moreover, liquid such as physiological saline used for rinsing the bone fragments during the drilling process flows within the substrate through the drainage channel 7. It eventually flows out of the osteotomy guide plate, which not only will not block the nail hole but can also play a role in assisting the substrate to cool down.

(20) Of course, in consideration of the problem of storage and searching of a plurality of osteotomy guide plates during use, a convex mark 8 may be provided on the surface of the substrate 1, and the convex mark 8 may be a name or a short name of a patient, or the like.

(21) A method for preparing a mandibula osteotomy guide plate is provided, comprising the steps of:

(22) A. Parameter Design

(23) (1) creating data for the standardized part: using digital technology to create data for the osteotomy guide standardized part 2, the standardized sleeve 41, and the protective inner sleeve standardized part 6 respectively for later use;

(24) wherein, in the creation of the data, the basic structure of the osteotomy guide standardized part 2 is a hollowed-out chamfered cuboid, and the size parameters (length×width×height) of the outer wall and the lumen are fixed values, and two fixed values are provided for the osteotomy guide standardized part 2 described in the present invention, one for the jawbone osteotomy guide plate and the other for the bone grafting osteotomy guide plate; the width of the lumen of the osteotomy guide standardized part 2 is matched with the thickness of the saw blade of an oscillating saw or sagittal saw used in the surgery, and the long diameter of the inner cavity is a fixed value, which is greater than the width of the standardized substrate, in order to provide additional space for the drainage of the osteotomy guide plate. The osteotomy guide through groove 21 in the osteotomy guide standardized part 2 in the surgery guides the surgeon to insert the oscillating saw or the sagittal saw into the groove for the osteotomy operation, and each of the independent osteotomy guide plates is equipped with one or more osteotomy guide standardized parts 2 of the same quantity as the that of osteotomy lines.

(25) The basic structure of the standardized sleeve 41 is a cylindrical structure with fixed values in wall thickness, height and diameter. The inner wall of the standardized sleeve 41 is provided with two independent grooves for locking with the protective inner sleeve standardized part 6, and the size parameters of the groove are matched with the protective inner sleeve standardized part 6.

(26) The basic structure of the protective inner sleeve standardized part 6 is a cylindrical structure, with fixed values in the wall thickness, height and diameter, and made of stronger materials than the standardized sleeve 41, such as stainless steel, titanium alloy, etc. The protective inner sleeve standardized part 6 is a 3D printed or machined part. A convex prismoid 61 is disposed on the outer wall of the protective inner sleeve standardized part 6, where the prismoid 61 is locked with a groove on the inner wall of the standardized sleeve 41. The size parameters of the prismoid 61 are matched with the outer wall of the protective inner sleeve standardized part 6.

(27) (2) extracting data of the nail hole: importing a postoperative mandibular model and a postoperative bone graft model of a patient and conducting simulation matching, and obtaining a restoration model by 3D printing technology, shaping a metal graft 8 with a mounting hole 91 onto the restoration model, and perforating in the restoration model along the mounting hole by a drilling device to form a nail hole site; placing the restoration model with the nail hole site in a 3D scanner for scanning, and then establishing the fitting parameter cylinder in the space of the nail hole site, wherein the parameter distribution range of the fitting parameter cylinder covers the postoperative bone stump and the bone surface after the bone grafting, the data of the nail hole is extracted according to the fitting parameter cylinder, and the new model with the nail hole feature is saved for the subsequent design processes;

(28) (3) creating data for the hole-free guide plate: importing a pre-operative mandibular model, confirming the coverage area of the substrate 1 and the position of the osteotomy line according to the surgical plan, and generating a model of the substrate 1, wherein the undulating condition of the inner side of the substrate 1 is matched with that of the surface of the preoperative mandibular model, and the substrate 1 covers the whole osteotomy line; and then, importing the data of the osteotomy guide standardized part 2, selecting the data of the osteotomy guide standardized part 2 adapted to the substrate 1, and extracting a main inertia axis of the osteotomy guide standardized part 2 (i.e., the axis for guiding the direction of the osteotomy line) using digital technology, matching the axis with the axial position of the mandibular osteotomy line, that is, obtaining the osteotomy guide through groove 21 accurately placed at the axis of the osteotomy line; and

(29) (4) creating the data of the osteotomy guide plate: importing the data of the nail hole and the data of the standardized sleeve 41, extracting the main inertia axis of the standardized sleeve 41 by digital technology, matching the main inertia axis with the data of the nail hole 4, and setting the distance between the top end of each standardized sleeve 41 and the bone surface to a fixed value, in order to match the data of the standardized sleeve 41 respectively with the data of the nail hole 4, then using digital technology to create a cylinder of the expected size, moving the cylinder to the expected position and axially passing through the model of the substrate 1, and cutting the model of the substrate 1 by Boolean operation function, completing the creation of the guide plate retention hole 3, and finally finishing the design of all parameters of the osteotomy guide plate;

(30) B. Model Printing

(31) importing the parameters of the osteotomy guide into a 3D printer for printing, and then embedding the printed protective inner sleeve standardized part 6 in the standardized sleeve 41 to obtain the osteotomy guide plate.

(32) According to an embodiment of the present application, a method for preparing an osteotomy guide plate, is shown in FIG. 7.

Embodiment 2

(33) As shown in FIG. 5, the present invention provides a fibula osteotomy guide plate. Unlike the embodiment 1, the substrate of the fibula osteotomy guide plate is a cuboid standardized part. When preparing the fibula osteotomy guide plate, the creating the data of the substrate 1 comprises generating a parameter fitting cuboid in the coverage area of the fibula model firstly, and then selecting the data of the appropriate cuboid standardized part to be imported, and matching the main inertia axis of the cuboid standardized part with the parameter cuboid to obtain the substrate 1 adapted to the appropriate position. The other steps are the same as in the embodiment.

(34) The jawbone osteotomy guide plate of the present invention is used as follows:

(35) 1. the surgeon entrusts the relevant personnel to perform ethylene oxide sterilization to the mandibular osteotomy guide plate, and then delivers the sterilized mandibular osteotomy guide plate to the operating room;

(36) 2. the surgeon then exposes the jawbone operation area after opening the flap, and then places the mandibular osteotomy guide plate at the osteotomy position and fixes it with a metal screw at the nail hole 4. It then inserts the osteotomy guide through groove 21 using a sagittal saw or an oscillating saw (conventional operating room power system) for osteotomy operation;

(37) 3. the surgeon or the assistant uses the syringe filled with physiological saline to inject the physiological saline into the substrate 1 through the drainage channel 7 to flush the bone fragments out of the inner wall of the substrate 1 and assist the substrate 1 to cool down; and

(38) 4. the surgeon inserts the drilling device (the drill bit connected to the power system or the handle) into the protective inner sleeve standardized part 6 for drilling operation. The surgeon or the assistant uses the syringe filled with the physiological saline to inject the physiological saline into the substrate 1 through the drainage channel in the same way, in order to flush the bone fragments out of the inner wall of the substrate 1 and assist the substrate 1 to cool down. After use of the mandibular osteotomy guide plate, the retention screw, and the mandibular osteotomy guide plate are removed.

(39) The fibula osteotomy guide plate of the present invention is used in a different way from that of the mandibular osteotomy guide plate in that: the osteotomy operation and the drilling positioning are performed on the fibula using the fibular osteotomy guide plate. Then, the titanium plate nails are placed on the cut bone graft segment (possibly together with the blood vessel) according to the nail hole site in the fibula osteotomy guide plate, and the fibula bone graft segment with the fixed titanium plate nails is transplanted into the jawbone segment, and the other screws are fixed through the guide plate retention hole 3.

(40) The above only describes specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any change or substitution that can be easily conceived by those skilled in the art within the disclosed technical scope of the present invention should be covered by the scope of the present invention. Therefore, the scope of the invention should be determined by the scope of the appended claims.