WO2022025653A1 - Method for manufacturing surgical guide, surgical guide, and recovery guide - Google Patents

Abstract

The present invention relates to a surgical guide designed on the basis of acquired patient medical image data including at least a surgical site, the surgical guide comprising: at least one first display unit used to display a first reference point for positioning the surgical guide on the surgical site; a second display unit used to display a second reference point for inserting an implant into the surgical site before surgery; a third display unit used to display a third reference point for fixing the implant in the surgical site during the surgery; and a surgical guide body, which is a mesh structure connecting the at least one first display unit, the second display unit, and the third display unit to one another and which covers the entire surgical site. Thus, the implant can be located at an accurate position, and the surgical plan is accurately reflected.

Description

How to make surgical guides, surgical guides and recovery guides

The present invention relates to a method for manufacturing a guide for surgery based on patient medical image data, a guide for surgery, and a guide for recovery.

Rhinoplasty is performed when there is a congenital deformity of the nose, or when there is a deformity in the nose area due to an accidental fracture, sleep disturbance, or cosmetic reasons.

The method of rhinoplasty performed at this time is very diverse, and the surgical method changes depending on the patient's condition, needs, type of deformation, the type and method of previous surgery, etc. is on an increasing trend.

Meanwhile, with the advent of the 4th industrial revolution, the form of product production is changing from simple mass production to producing customized products using ICT-based technology. In particular, the 3D printing industry, a core technology of the 4th industrial revolution, is being introduced into the medical field, centered on the manufacturing industry, and is typically applied to the production of practice products for surgical simulation, pharmaceutical printing, and the production of customized medical implants.

During rhinoplasty, surgery planning for the height and shape of the nose bridge is made based on a flat image extracted from a CT scan image or a flat image taken from a photograph. There is a problem that is not accurately reflected during this operation.

In addition, since the position where the implant is inserted depends on the difference in the doctor's skill, experience, palpation, and the naked eye, there is a problem that the implant is not positioned correctly according to the plan.

Accordingly, an object of the present invention is to provide a method for manufacturing a guide for surgery, a guide for surgery, and a guide for recovery in which the surgical plan can be accurately reflected.

Another object of the present invention is to provide a method for manufacturing a surgical guide capable of positioning an implant in an accurate position, a surgical guide, and a recovery guide.

The problems to be solved by the present invention are not limited to the problems mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art from the following description.

The above object, according to a first aspect of an embodiment of the present invention,

In the method of manufacturing a guide for surgery,

acquiring patient medical image data including at least a surgical site;

designing a surgical guide based on the acquired patient medical image data; and

Including the step of producing the designed surgical guide,

At this time, the step of designing the surgical guide,

forming at least one first indicator used to display a first reference point for positioning the surgical guide on the surgical site;

forming a second display unit used to display a second reference point for implant insertion in the surgical site prior to surgery;

forming a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery; and

The mesh structure connecting the at least one first display unit, the second display unit, and the third display unit to each other is achieved by including the step of forming a guide body for surgery that covers the surgical site as a whole.

In this case, the step of designing the surgical guide based on the obtained patient medical image data may include: directly from the obtained patient medical image data, or by obtaining virtual surgery data from the obtained patient medical image data for surgery Guides can be designed.

In this case, at least one of the first to third display units may have a shape of a groove or a wedge, and in each of the second display unit or the third display unit, the second reference point or the third reference point by the display means A hole for facilitating separation of the surgical guide from the surgical site in which the display means is present after display may be further provided.

Furthermore, the surgical guide is a guide for nose plastic surgery,

In this case, it is preferable that the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, and the third reference point is determined based on the nostril point.

In addition, the manufacturing of the designed surgical guide may use at least one of 3D printing, cutting, injection, mold, and vacuum molding.

In addition, the method of manufacturing a surgical guide according to the present invention is

designing a recovery guide based on the obtained patient medical image data; and

Further comprising the step of producing the designed recovery guide,

The step of designing the recovery guide,

As a mesh structure having a mesh size smaller than that of the guide body for surgery, it may include forming a guide body for recovery having a size larger or smaller than the guide body for surgery.

The above object, according to a second aspect of an embodiment of the present invention,

It is achieved by a surgical guide manufactured according to the above method.

The above object, according to a third aspect of an embodiment of the present invention,

It is achieved by a recovery guide manufactured according to the above method.

The above object, according to a fourth aspect of an embodiment of the present invention,

In the surgical guide designed based on the acquired patient medical image data including at least the surgical site,

at least one first display unit used to display a first reference point for positioning the surgical guide on the surgical site;

a second display unit used to display a second reference point for implant insertion into the surgical site prior to surgery;

a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery; and

A mesh structure connecting the at least one first display unit, the second display unit, and the third display unit to each other is achieved by including a guide body for surgery that covers the surgical site as a whole.

In this case, at least one of the first to third display units may have a groove or wedge shape, and the second or third reference point is displayed by a display means on each of the second display unit or the third display unit. Afterwards, a hole for facilitating separation of the surgical guide from the surgical site in which the display means is present may be further provided.

Furthermore, the surgical guide is a guide for nose plastic surgery,

In this case, it is preferable that the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, and the third reference point is determined based on the nostril point.

In addition, the designed surgical guide may be manufactured using at least one of 3D printing, cutting, injection, mold, and vacuum molding.

The above object, according to a first aspect of an embodiment of the present invention,

In the method of manufacturing a guide for surgery,

acquiring patient medical image data including at least a surgical site;

designing a surgical guide based on the acquired patient medical image data; and

Including the step of producing the designed surgical guide,

At this time, the step of designing the surgical guide,

forming a plurality of first indicators used to indicate each of a first reference point for positioning of the surgical guide on the surgical site;

As a mesh structure connecting the plurality of first display units to each other, it is achieved by a method of manufacturing a surgical guide, characterized in that it comprises the step of forming a surgical guide body covering the surgical site as a whole.

In addition, the step of designing the surgical guide,

Further comprising the step of forming a fourth display unit used to display a fourth reference point for determining the correct shape of the surgical site after surgery, or for inserting an implant into the surgical site before surgery, different from the fourth reference point The method may further include forming a second display unit used to display another second reference point.

Here, the second display unit may have a shape of a groove, a hole, or a combination thereof.

In this case, the step of designing the surgical guide based on the obtained patient medical image data may include: directly from the obtained patient medical image data, or by obtaining virtual surgery data from the obtained patient medical image data for surgery Guides can be designed.

In this case, the plurality of first display units may have protrusions including grooves or wedge-shaped holes.

Furthermore, the step of designing the surgical guide,

The method may further include forming a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery.

Furthermore, the surgical guide is a guide for nose plastic surgery,

In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, the third reference point is determined based on the nostril point, and the fourth reference point It is preferable to be determined based on the nose line after surgery.

In addition, the manufacturing of the designed surgical guide may use at least one of 3D printing, cutting, injection, mold, and vacuum molding.

In addition, the method of manufacturing a surgical guide according to the present invention is

designing a recovery guide based on the obtained patient medical image data; and

Further comprising the step of producing the designed recovery guide,

The step of designing the recovery guide,

As a mesh structure having a mesh size smaller than that of the guide body for surgery, it may include forming a guide body for recovery having a size larger or smaller than the guide body for surgery.

At this time, the step of designing a guide for recovery based on the obtained patient medical image data,

A guide for recovery may be designed directly from the acquired medical image data of the patient or by acquiring virtual surgery data from the acquired medical image data of the patient.

The above object, according to a second aspect of an embodiment of the present invention,

It is achieved by a surgical guide manufactured according to the above method.

The above object, according to a third aspect of an embodiment of the present invention,

It is achieved by a recovery guide manufactured according to the above method.

The above object, according to a fourth aspect of an embodiment of the present invention,

In the surgical guide designed based on the patient medical image data including at least the surgical site,

a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and

Includes a guide body for surgery,

The surgical guide body, as a mesh structure connecting the plurality of first display units to each other, has a mesh size of a predetermined size and is formed to cover the surgical site as a whole, achieved by a surgical guide do.

Further, the surgical guide,

A second reference point different from the fourth reference point for inserting an implant into the surgical site during surgery or further comprising a fourth display unit used to display a fourth reference point for correct shape determination of the surgical site after surgery It may further include a second display unit used to display.

In this case, the second display unit may have a shape of a groove, a hole, or a combination thereof, and the plurality of first display units may have a protrusion including a groove or a wedge-shaped hole.

Additionally, the surgical guide may further include a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery.

Here, the surgical guide is a guide for nose plastic surgery,

In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, the third reference point is determined based on the nostril point, and the fourth reference point It is preferable to be determined based on the nose line after surgery.

The surgical guide designed in this way may be manufactured using at least one of 3D printing, cutting, injection, mold, and vacuum molding.

The above object, according to a fifth aspect of an embodiment of the present invention,

In the recovery guide used after surgery as a surgical guide designed based on patient medical image data including at least a surgical site,

The surgical guide may include: a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and a guide body for surgery,

The guide body for recovery, as a mesh structure having a shorter length and wider width than the guide body for surgery, has a mesh size of a predetermined size and is formed to cover the surgical site as a whole,

In addition, the recovery guide body further comprises two wings for assisting quick recovery, each wing starting below the first reference point and having the widest width above the recovery guide body length, characterized in that which is achieved by a guide for recovery.

In addition, according to the sixth aspect of an embodiment of the present invention,

In the recovery guide designed based on the patient medical image data including at least the surgical site,

Comprising a guide body for recovery,

The guide body for recovery, as a mesh structure, has a mesh size of a predetermined size, characterized in that formed so as to cover the surgical site as a whole, is achieved by the recovery guide.

The above object, according to a seventh aspect of an embodiment of the present invention,

In the recovery guide used after surgery as a surgical guide designed based on patient medical image data including at least a surgical site,

The surgical guide may include: a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and a guide body for surgery,

The guide body for surgery is a mesh structure connecting the plurality of first display units to each other, has a mesh size of a predetermined size and is formed to cover the surgical site as a whole,

The recovery guide is a mesh structure having a smaller mesh size than the surgical guide body, characterized in that it comprises a recovery guide body having a larger or smaller size than the surgical guide body, in a recovery guide achieved by

Additionally, the recovery guide is a guide for recovery from rhinoplasty, and it is preferable to further include two wings for respectively compressing the puffiness under the eyes.

According to the method for manufacturing the surgical guide of the present invention as described above, the surgical guide and the recovery guide, the surgical guide that follows the contour of the surgical site that reflects the surgical plan as it is is used, so the surgical plan can be accurately reflected. There is this.

In addition, according to the method of manufacturing the surgical guide of the present invention, the surgical guide and the recovery guide, it is possible to easily locate the implant regardless of the surgeon's skill, experience, etc., so that the implant can be positioned in an accurate position There are advantages.

1 is a flowchart of a method of manufacturing a surgical guide according to an embodiment of the present invention.

2a to 2c, 2e to 2i are views showing a method of designing a surgical guide according to an embodiment of the present invention.

2D is an embodiment of a surgical guide according to the present invention.

3A and 3B are embodiments of a recovery guide according to the present invention.

Figure 3c is a view showing an example of the use of the guide for recovery according to the present invention.

Figure 4a is a top view of the surgical guide according to an embodiment of the present invention, Figure 4b is a side view of the surgical guide according to an embodiment of the present invention.

Figure 5a is a top view of the surgical guide according to an embodiment of the present invention, Figure 5b is a side view of the surgical guide according to an embodiment of the present invention.

6A to 6L are views showing modified examples of a surgical guide according to an embodiment of the present invention.

7 and 8 each show exemplary views for defining the dimensions of each part of the surgical guide according to the present invention.

9 is a view showing an example of the second display unit of the surgical guide according to an embodiment of the present invention.

10 is a view showing an example of using a guide for surgery according to an embodiment of the present invention.

11A to 11C are views illustrating various types of implants.

Hereinafter, exemplary embodiments according to the present invention will be described in detail with reference to the contents described in the accompanying drawings. However, the present invention is not limited or limited by the exemplary embodiments. The same reference numerals provided in the respective drawings indicate members that perform substantially the same functions.

Terms including an ordinal number such as 1st, 2nd, etc. may be used to describe various elements, but the elements are not limited by the terms. The above terms are used only for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a second component, and similarly, the second component may also be referred to as a first component. The terms used in the present application are only used to describe specific embodiments, and are not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly dictates otherwise.

The terms used in the present invention have been selected as currently widely used general terms as possible while considering the functions in the present invention, but these may vary depending on the intention or precedent of a person skilled in the art, the emergence of new technology, and the like. In addition, in a specific case, there is a term arbitrarily selected by the applicant, and in this case, the meaning will be described in detail in the description of the corresponding invention. Therefore, the term used in the present invention should be defined based on the meaning of the term and the overall content of the present invention, rather than the name of a simple term.

In the entire specification, when a part "includes" a certain element, this means that other elements may be further included, rather than excluding other elements, unless otherwise stated.

1 is a flowchart of a method of manufacturing a surgical guide according to an embodiment of the present invention.

Referring to FIG. 1 , a method for manufacturing a surgical guide according to an embodiment of the present invention includes essentially acquiring patient medical image data (S100); Designing a surgical guide based on the acquired patient medical image data (S200); and manufacturing a designed surgical guide (S300).

First, in the step (S100) of acquiring the patient medical image data, the patient medical image data is image data including at least a surgical site, such as a CT image, 3D scanning data, etc., from which the three-dimensional image data before and/or after surgery Any image data can be used as long as the overall contour of the surgical site can be estimated.

The step (S200) of designing a surgical guide based on the thus obtained patient medical image data may be implemented in common software such as CAD. The method of designing a surgical guide according to an embodiment of the present invention is Hereinafter, it will be described with reference to FIGS. 2A to 2M.

At this time, the step of designing a surgical guide based on the obtained patient medical image data (S200) is to obtain 3D virtual surgery data directly from the obtained patient medical image data or from the obtained patient medical image data and perform surgery therefrom. A guide may be designed for a surgical guide, and the process of acquiring such virtual surgical data may be implemented as a separate software or integrated with software that assists in designing a surgical guide, with or without big data and/or AI. have.

Here, the obtained virtual surgery data includes the shape of the implanted prosthesis and the image of the post-operative surgical site, and the surgical guide may be designed based on this.

The method of designing a surgical guide according to an embodiment of the present invention basically forms (1) at least one first display unit used to display a first reference point for positioning the surgical guide on the surgical site. to do; (2) forming a second display unit used to display a second reference point for implant insertion in the surgical site prior to surgery; (3) forming a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery; and (4) forming a guide body for surgery that is a mesh structure connecting at least one of the first display unit, the second display unit, and the third display unit to each other, and covers the surgical site as a whole.

For clarity of explanation, a method of designing a guide for surgery according to the present invention will be described with an example of a method of designing a guide for cosmetic surgery of the nose.

First, as shown in Figure 2a, the part necessary for the design work of the surgical guide, that is, the surgical site that can be covered by the surgical guide body is cut from the post-operative surgical site image obtained from the patient medical image data, and prepared.

Based on the surgical site prepared in this way, as shown in Fig. 2b, the contour of the overall surgical guide is determined, and the contour of the determined surgical guide is, for example, 0.5 mm to 1.5 mm based on the contour of the ideal surgical site. It can be decided by giving an offset. Of course, this offset is not limited to the above numerical values, and may be set flexibly in consideration of expected swelling after surgery, taping thickness, and the like.

(1) The step of forming at least one first display unit used to display a first reference point for positioning of the surgical guide on the surgical site is, in this embodiment, as in FIG. 2C, for rhinoplasty surgery The first reference point 10 for accurate positioning of the guide may be based on the patient's eye.

For more accurate and stable positioning, the first reference point may form two first display units 10a or 10b based on both eyes of the patient. In this case, since each of the first display units 10a or 10b only needs to be suitable for displaying the positions of both eyes, any shape is possible, and as shown in FIG. 2D , they may have a groove or wedge shape (see 10b). ), or in the form of a protrusion extending outward (see 10a).

(2) The step of forming a second display unit used to display a second reference point for implant insertion in the surgical site prior to surgery is, as shown in FIG. 2 The reference point 20 may be based on the starting point of the implant. Here, in general, the starting point of the implant may be located between the Glabella and the Radix depending on the shape of the implant, and in this case, the second display portion 20a may have a groove or wedge shape, as shown in FIG. 2D . have.

Furthermore, the second reference point may be marked by a needle or other marking means before the implant is inserted. In the case of removing the surgical guide after the display by the display means and proceeding with surgery, the first hole 50a for facilitating separation of the surgical guide from the surgical site where the display means is present is provided in the second display part It may be provided adjacent to (20a). Preferably, the size or shape of the first hole is sufficient as long as it is large enough for the display means to pass therethrough.

(3) The step of forming the third display unit used to display the third reference point for fixing the implant to the surgical site during the operation is the third reference point for fixing the implant for rhinoplasty in the embodiment of the nasal bone and cartilage. It can be based on a boundary, ie a rhinion. In this case, the third display unit 30a may have a shape of a groove or a wedge, as shown in FIG. 2D .

Furthermore, the third reference point may be used to mark and fix the position of the implant by using a display means such as a needle to prevent it from being moved and deviated from its position after the implant is inserted. In the case of removing the surgical guide after the display by the display means and proceeding with surgery, the second hole 60a for facilitating separation of the surgical guide from the surgical site where the display means is present is provided in the third display part It may be provided adjacent to (30a). Preferably, the size or shape of the second hole is sufficient as long as it is large enough for the display means to pass therethrough.

Of course, the positions, shapes, sizes, and numbers of the first to third display units and the first and second holes may be changed as needed.

For example, referring to FIGS. 6A to 6L , FIGS. 6A to 6D , when compared with reference to FIG. 6D (see FIG. 2D ), the second display unit is a groove (201) and a rounded rectangle (202). , the arc shape 203 is changed, and FIGS. 6E to 6G are examples in which the first display unit is changed to a wedge shape, compared with FIGS. 6A to 6D, and FIGS. 6I to 6L are, FIGS. 6A to 6D , Compared with 6d, these are examples in which the first display unit is changed to a protrusion and has a relatively narrow width.

The size of these surgical guides, but is not limited thereto, each part dimension with reference to FIG. 7 (corresponding to FIG. 6A ), for example, may be defined as follows, where the unit is mm.

No Yes (based on Fig. 6) A B C D E T One (a) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 2 (b) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 3 (c) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 4 (d) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 5 (e) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 6 (f) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 7 (g) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0 8 (h) 10.0~80.0 23.0-124.0 51.0~97.0 9.0~45.0 0-12.0 1.5~3.0

In addition, the size of these surgical guides, but is not limited thereto, each part dimension with reference to FIG. 8 (corresponding to FIG. 6i ) may be defined, for example, as follows, where the unit is mm .

No Yes (based on Fig. 6) A B C D E T One (i) 10.0-70.0 23.0-124.0 41.0~97.0 9.0~45.0 0-12.0 1.5~3.0 2 (j) 10.0-70.0 23.0-124.0 41.0~97.0 9.0~45.0 0-12.0 1.5~3.0 3 (k) 10.0-70.0 23.0-124.0 41.0~97.0 9.0~45.0 0-12.0 1.5~3.0 4 (l) 10.0-70.0 23.0-124.0 41.0~97.0 9.0~45.0 0-12.0 1.5~3.0

The sizes of these surgical guides have been exemplified based on modified examples of an embodiment of the present invention, but the dimensions of each part are also applicable to an embodiment to be described later as it is.

(4) a mesh structure connecting at least one of the first display unit, the second display unit, and the third display unit to each other, the step of forming a surgical guide body covering the surgical site as a whole is shown in Figs. As in 2h, the center line 100 is first formed (see Fig. 2e), and vertical lines (for example, 100a, 100b) are created at predetermined intervals (see Fig. 2f), then rotated 90 degrees to form horizontal lines at predetermined intervals. By creating (for example, 100a', 100b', 100c', 100d', 100e') (see FIG. 2g ), the mesh structure of the surgical guide body is implemented (see FIG. 2h ), and the surgical guide determined above Combined with the outline of (see Fig. 2i) to finalize the design of the final surgical guide. At this time, the mesh size of the mesh structure of the guide body for surgery is determined based on the spacing between the vertical lines and the horizontal lines, which can be adjusted as needed.

The method of designing a surgical guide according to an embodiment of the present invention basically forms (1) a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site. to do; (2) forming a fourth display unit used to display a fourth reference point for determining the correct shape of the surgical site after surgery; optionally (3) forming a second display unit used to display a second reference point different from the fourth reference point for inserting the implant into the surgical site prior to surgery; and (4) a mesh structure connecting at least the plurality of first display units to each other, and forming a surgical guide body covering the surgical site as a whole.

Since the method of designing a surgical guide according to an embodiment of the present invention can be applied by adopting an embodiment, except for the details of the fourth display unit and the second display unit, the overlapping parts will be omitted. decide to do

Referring to FIG. 5A, which is a top view of a surgical guide according to an embodiment of the present invention, and FIG. 5B, which is a side view of a surgical guide according to an embodiment of the present invention, for more accurate and stable positioning, the first reference point is the patient Based on both eyes of , a plurality of first display units 11a may be formed. At this time, since each of the first display units 11a only needs to be suitable for displaying the positions of both eyes, any shape may be used, and as shown in FIG. 5A , the first display units 11a may have a protrusion including a groove or wedge-shaped hole. .

The step of forming a fourth display unit used to display a fourth reference point for accurate shape determination of the surgical site after surgery is to set the fourth reference point 40a based on the post-operative nose line in the embodiment. can That is, for example, at least one point on the nose line that is to be raised or lowered by nasal surgery, that is, changed after surgery, for example, a point in the middle between the glabellar and the tip of the nose, with or without implants, It may include the end point where the implant is inserted, or the end point of the nose line (corresponding to the highest height), the glabellar area, and/or the nasal muscle, and is preferably located along the center line. Thus, in one embodiment, since it is possible to check whether the implant is correctly inserted into the position during the operation based on the fourth reference point, the third display unit used to display the third reference point for fixing the implant to the surgical site during the operation It becomes possible to omit the forming step.

The step of forming a second display unit used to display a second reference point different from the fourth reference point for implant insertion of a surgical site during surgery is, in the embodiment, a second reference point for inserting an implant for rhinoplasty surgery (21a) can be based on the starting point of the implant. Here, in general, the starting point of the implant may be located between the glabella and the radix depending on the shape of the implant, which can be seen with reference to FIGS. 11A to 11C showing various types of implants. For example, if the height between the eyes of the implant is higher than the height of the tip of the nose, the starting point of the implant may be located close to the forehead (refer to FIG. 11A) It may be (see FIG. 11b), and when the height between the eyes and the tip of the nose are overall high, it may be located in the middle of the glabellar and nasal muscles (see FIG. 11c).

In this case, the second display unit 21a may have the form of a groove, a hole, or a combination thereof. For example, as shown in FIG. 5A , it may have the form of an arc hole, and the starting point of the implant is based on the arc hole, for example. For example, as shown in FIG. 9 , the arc hole may be formed so that the starting point 71 of the implant 70 is located in the center of the arc hole 21b.

10 is a view showing an example of using a guide for surgery according to an embodiment of the present invention. As can be seen from the drawing, the surgical guide is seated by aligning the first display unit 11b with both eyes and the fourth display unit 40b with the tip of the nose. In addition, it can be seen from FIG. 9 that the second display unit 21b is seated according to the starting point of the implant.

Additionally, in one embodiment, the method may further include forming a third display unit used to display a third reference point for fixing the prosthesis to the surgical site during surgery to set a more robust fixation position. The third reference point for fixing the prosthesis for rhinoplasty may be based on the boundary between the nasal bone and cartilage, that is, the rhinion.

As a mesh structure for connecting at least a plurality of first display units to each other, the step of forming a surgical guide body covering the surgical site as a whole is also applied similarly to the embodiment. Of course, when the second to fourth display units are present, it is clear that a mesh structure connecting them is also formed (refer to FIGS. 5A and 5B ).

At this time, the mesh structure can be used to create a surgical guide according to the doctor's needs and the patient's anatomy. There are advantages. In particular, since the mesh structure is applied to the inserted surgical guide, it is spatially empty to check the state of the implant during surgery, so it is easy to check whether the implant is seated well from the side without lifting the surgical guide. do.

At this time, according to the needs of the designer, the entire guide body for surgery may be designed in a mesh structure, and only a part of the guide body may be designed in a mesh structure.

In addition, after designing the mesh structure using the center line, horizontal line, and vertical line, a design step such as transformation into a hole structure may be added. This allows the centerline to be visible or invisible in the final mesh structure. Alternatively, of course, it may be designed as a polygon, a circle, a hybrid structure in which a polygon and a circle are mixed, and the like.

Next, the step (S300) of manufacturing a surgical guide designed in this way is not limited thereto, but may be implemented using at least one of 3D printing, cutting, injection, mold, and vacuum molding.

Therefore, by using the surgical guide manufactured according to the method of manufacturing the surgical guide according to the present invention, it is possible to position and/or fix the implant in an accurate position before and/or during surgery, thereby accurately performing the surgical plan. It can be reflected in surgery. In addition, this surgical guide can be used as a guide for recovery after surgery. Due to the mesh structure covering the surgical site as a whole, the step with the skin can be easily checked, so the overall surgical plan is accurately reflected in the operation It can also be checked directly.

Furthermore, this surgical guide may be used as it is for recovery, but separately from this surgical guide, a recovery guide functioning as a splint may be designed and manufactured in a similar manner to be used separately for recovery.

Referring back to Figure 1, the method of manufacturing a guide for surgery according to an embodiment of the present invention, further designing a guide for recovery based on the obtained patient medical image data (S400); And it may further include a step (S500) of manufacturing a designed recovery guide.

At this time, the step of designing the guide for recovery, as in FIGS. 3A and 3B, may be implemented with conventional software such as CAD, in consideration of the rigidity and breathability as a splint, a mesh having a smaller mesh size than the surgical guide body As a structure, comprising the step of forming a guide body for recovery having a larger or smaller size than the guide body for surgery.

In order to be used as a guide for recovery after surgery, although not limited thereto, the mesh size has to be strong to protect the surgical site well compared to the surgical guide, which has a relatively large mesh size so that the surgical site can be seen well during surgery, so a relatively dense structure and/or it may be desirable for the guide body to be relatively large (see FIG. 3b ). Alternatively, it may be preferable to have a relatively small size in consideration of long-term wear and aesthetics after surgery (see FIG. 3A ).

Looking in more detail with reference to FIG. 3B , the recovery guide also determines the overall outline of the guide based on the patient's medical image data like the surgical guide, so the overall outline may be similar to the surgical guide, but the region For each, the outline and length may be slightly different.

For example, based on the part where the nose line starts after surgery, the upper portion (U) has a similar length to the surgical guide and the recovery guide, while the lower portion (L) has a shorter length of the recovery guide compared to the surgical guide. can be short It is advantageous for the surgical guide to have a shape that covers the tip of the nose so that the operation can proceed well according to the surgical plan, but the shape of the tip of the nose is an area left to the discretion of the doctor. It may be more advantageous not to wrap the

Further, the width of the recovery guide may include a wider portion than the width of the surgical guide, for example, based on the central portion (M) corresponding to the body of the surgical guide, each compressing the swelling under the eyes This is because it can be configured to further include wings (LW, RW) for the.

Figure 3c is a view showing an example of using such a guide for recovery according to an embodiment of the present invention. As can be seen in the drawing, the recovery guide has an upper length similar to that of the corresponding surgical guide and, unlike the surgical guide including a first display unit that is fitted to both eyes during surgery, continuously wears and lives. Considering the characteristics of the splint that needs to be done, it does not include such a first display unit for safety (eg, prevention of injury due to the protruding first display unit) and convenience in daily life, and also has a corresponding surgical guide to expose the tip of the nose. It has a shorter lower length than

Additionally, based on the central portion corresponding to the surgical site and/or the body of the surgical guide, to aid in quick recovery, two wings are included to respectively compress the puffiness under the eyes. Each wing starts below the eye and ends at the end of the guide body for recovery, and has a predetermined area showing the widest width in the middle including the boundary between the starting point 80 and the ending point 81 below the eye. , in more detail, it can be seen in FIG. 3c that it corresponds to the cheek portion next to the bridge of the nose including under the eyes. Of course, the two wings may have the same shape or may have different shapes, and if necessary, the end point of the wing may be located above the end of the recovery guide body, and a midpoint 82 showing a wide width is also required The location may be determined accordingly.

Similar to the step of producing a surgical guide, it is possible to design a recovery guide from the obtained 3D virtual surgical data directly from the acquired patient medical image data or from the acquired patient medical image data, and such virtual surgical data The process of acquiring the ? may be implemented in software that assists in the design of a surgical or recovery guide, or as separate software, with or without big data and/or AI.

Here, the acquired virtual surgery data includes the shape of the implanted prosthesis and the image of the postoperative surgical site, and the surgical guide may be designed based on this.

Figure 4a is a top view of the surgical guide according to an embodiment of the present invention, Figure 4b is a side view of the surgical guide according to an embodiment of the present invention.

4A and 4B , a surgical guide designed based on acquired medical image data of a patient including at least a surgical site is used to mark a first reference point for positioning the surgical guide on the surgical site at least one first display unit 10a'; a second display unit (20a') used to display a second reference point for implant insertion into the surgical site prior to surgery; a third display unit (30a') used to display a third reference point for fixing the implant to the surgical site during surgery; and a mesh structure connecting at least one of the first display unit 10a ′, the second display unit 20a ′, and the third display unit 30a ′ to each other, the surgical guide body 1 ′ covering the surgical site as a whole. includes

As described above, at least one of the first to third display units may have a groove or wedge shape, and each of the second display unit 20a' or the third display unit 30a' has a second A first hole or a second hole (50a' or 60a') for facilitating separation of the surgical guide from the surgical site in which the display means is present after the display of the reference point or the third reference point may be further provided.

Figure 5a is a top view of the surgical guide according to an embodiment of the present invention, Figure 5b is a side view of the surgical guide according to an embodiment of the present invention.

5A and 5B , a surgical guide designed based on acquired medical image data of a patient including at least a surgical site is used to mark a first reference point for positioning the surgical guide on the surgical site a plurality of first display units 11a; A fourth display unit 40a used to display a fourth reference point for correct shape determination of the surgical site after surgery, a second reference point different from the fourth reference point for implant insertion into the surgical site during surgery a second display unit 21a used to and a mesh structure connecting at least the plurality of first display units 11a to each other, and a surgical guide body covering the surgical site as a whole.

As described above, the first display unit may have a protrusion including a groove or wedge-shaped hole, and the second display unit may have a shape that is a groove, a hole, or a combination thereof. With respect to the method according to the present invention, the descriptions of the functions and shapes of the first to fourth display units, the functions and shapes of the first and second holes, and the mesh structure described above may be equally applied thereto.

The surgical guide according to the present invention may be manufactured by the method of manufacturing the surgical guide according to the present invention, but is not necessarily limited thereto, and may be manufactured using any number of other manufacturing methods.

Terms used in this specification generally are intended to be "open-ended" terms, particularly in claims (eg, the body of claims) (eg, "comprising" means "including but not limited to" , "having" should be construed as "having at least more" and "comprising" as "including but not limited to" It is expressly recited in the claims, and in the absence of such recitation, no such intent is understood.

Only specific features of the invention have been shown and described herein, and various modifications and variations will occur to those skilled in the art. It is therefore to be understood that the claims are intended to cover changes and modifications that fall within the spirit of the invention.

Claims (41)

In the method of manufacturing a guide for surgery, acquiring patient medical image data including at least a surgical site; designing a surgical guide based on the acquired patient medical image data; and Including the step of producing the designed surgical guide, At this time, the step of designing the surgical guide, forming a plurality of first indicators used to indicate each of a first reference point for positioning of the surgical guide on the surgical site; As a mesh structure connecting the plurality of first display units to each other, it has a mesh size of a predetermined size and comprises the step of forming a guide body for surgery that covers the surgical site as a whole, manufacturing a surgical guide How to. The method of claim 1, The step of designing the surgical guide, Method of manufacturing a guide for surgery, characterized in that it further comprises the step of forming a fourth display unit used to display a fourth reference point for correct shape determination of the surgical site after surgery. 2. The method of claim 1 The step of designing the surgical guide, Method of manufacturing a surgical guide, characterized in that it further comprises the step of forming a second display unit used to display a second reference point different from the fourth reference point for implant insertion into the surgical site during surgery. 4. The method of claim 3, The second display unit, a method of manufacturing a surgical guide, characterized in that it has a shape that is a groove, a hole, or a combination thereof. 5. The method of claim 4, The step of designing a guide for surgery based on the obtained patient medical image data, Directly from the acquired patient medical image data or by acquiring virtual surgical data from the acquired patient medical image data to design a surgical guide therefrom. 6. The method of claim 5, The method of manufacturing a surgical guide, characterized in that the plurality of first display portion has a protrusion including a groove or wedge-shaped hole. 7. The method of claim 6 The step of designing the surgical guide, Method of manufacturing a surgical guide, characterized in that it further comprises the step of forming a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery. 8. The method according to any one of claims 1 to 7, The surgical guide is a guide for nose plastic surgery, In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, the third reference point is determined based on the nostril point, and the fourth reference point A method of manufacturing a guide for surgery, characterized in that it is determined based on the nose line after surgery. 9. The method of claim 8, The step of manufacturing the designed surgical guide, 3D printing, cutting, injection, mold, a method of manufacturing a surgical guide, characterized in that using at least one of vacuum molding. 10. The method of claim 9, designing a recovery guide based on the obtained patient medical image data; and Further comprising the step of producing the designed recovery guide, The step of designing the recovery guide, As a mesh structure having a mesh size smaller than that of the guide body for surgery, manufacturing a guide for surgery, characterized in that it comprises the step of forming a guide body for recovery having a size larger or smaller than the guide body for surgery Way. 11. The method of claim 10, The step of designing a recovery guide based on the obtained patient medical image data, Directly from the acquired patient medical image data or by acquiring virtual surgical data from the acquired patient medical image data to design a recovery guide therefrom. 10. A surgical guide manufactured according to the method of claim 1 to 9. A recovery guide made according to the method of claim 10 or 11. In the surgical guide designed based on the patient medical image data including at least the surgical site, a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and Includes a guide body for surgery, The surgical guide body is a mesh structure connecting the plurality of first display units to each other, has a mesh size of a predetermined size, and is formed to cover the surgical site as a whole. 15. The method of claim 14, The surgical guide, Surgical guide, characterized in that it further comprises a fourth display unit used to display a fourth reference point for correct shape determination of the surgical site after surgery. 15. The method of claim 14 The surgical guide, Surgical guide, characterized in that it further comprises a second display unit used to display a second reference point different from the fourth reference point for inserting the implant into the surgical site during surgery. 17. The method of claim 16, The second display unit, a guide for surgery, characterized in that it has a shape of a groove, a hole, or a combination thereof. 18. The method of claim 17, The plurality of first display units, surgical guide, characterized in that it has a protrusion including a groove or wedge-shaped hole. 19. The method of claim 18 The surgical guide, Surgical guide, characterized in that it further comprises a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery. 20. The method according to any one of claims 14 to 19, The surgical guide is a guide for nose plastic surgery, In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, the third reference point is determined based on the nostril point, and the fourth reference point A guide for surgery, characterized in that it is determined based on the nose line after surgery. 21. The method of claim 20, The designed surgical guide, 3D printing, cutting, injection, mold, surgical guide, characterized in that produced using at least one of vacuum molding. In the recovery guide used after surgery as a surgical guide designed based on patient medical image data including at least a surgical site, The surgical guide may include: a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and a guide body for surgery, The guide body for recovery, as a mesh structure having a shorter length and wider width than the guide body for surgery, has a mesh size of a predetermined size and is formed to cover the surgical site as a whole, In addition, the recovery guide body further comprises two wings for assisting quick recovery, each wing starting below the first reference point and having the widest width above the recovery guide body length, characterized in that doing, recovery guide. In the recovery guide designed based on the patient medical image data including at least the surgical site, Comprising a guide body for recovery, The recovery guide body is a mesh structure, characterized in that it has a mesh size of a predetermined size and is formed to cover the surgical site as a whole, recovery guide. In the recovery guide used after surgery as a surgical guide designed based on patient medical image data including at least a surgical site, The surgical guide may include: a plurality of first display units used to display each of the first reference points for positioning the surgical guide on the surgical site; and a guide body for surgery, The guide body for surgery is a mesh structure connecting the plurality of first display units to each other, has a mesh size of a predetermined size, and is formed to cover the surgical site as a whole, The recovery guide, as a mesh structure having a smaller mesh size than the guide body for surgery, characterized in that it comprises a guide body for recovery having a size larger or smaller than the guide body for surgery, recovery guide. 25. The method of claim 23 or 24, The recovery guide is a guide for the recovery of rhinoplasty surgery, Further comprising two wings for each compressing the puffiness under the eyes, recovery guide. In the method of manufacturing a guide for surgery, acquiring patient medical image data including at least a surgical site; designing a surgical guide based on the acquired patient medical image data; and Including the step of producing the designed surgical guide, At this time, the step of designing the surgical guide, forming at least one first indicator used to display a first reference point for positioning the surgical guide on the surgical site; forming a second display unit used to display a second reference point for implant insertion in the surgical site prior to surgery; forming a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery; and A mesh structure connecting the at least one first display unit, the second display unit, and the third display unit to each other, comprising the step of forming a guide body for surgery that covers the surgical site as a whole. How to craft a dragon guide. 27. The method of claim 26, The step of designing a surgical guide based on the obtained patient medical image data, Directly from the acquired patient medical image data or by acquiring virtual surgical data from the acquired patient medical image data to design a surgical guide therefrom. 28. The method of claim 27, At least one of the first to third display units is a method of manufacturing a guide for surgery, characterized in that it has the shape of a groove or a wedge. 29. The method of claim 28, In each of the second display unit or the third display unit, after the display of the second reference point or the third reference point by the display means, to facilitate separation of the surgical guide from the surgical site in which the display means is present. A method of manufacturing a guide for surgery, characterized in that the hole is further provided. 30. The method according to any one of claims 26 to 29, The surgical guide is a guide for nose plastic surgery, In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, and the third reference point is determined based on the nostril point, How to make surgical guides. 31. The method of claim 30, The step of manufacturing the designed surgical guide, 3D printing, cutting, injection, mold, a method of manufacturing a surgical guide, characterized in that using at least one of vacuum molding. 32. The method of claim 31, designing a recovery guide based on the acquired patient medical image data; and Further comprising the step of producing the designed recovery guide, The step of designing the guide for recovery, A mesh structure having a mesh size smaller than that of the guide body for surgery, characterized in that it comprises the step of forming a guide body for recovery having a size larger or smaller than the guide body for surgery, manufacturing a guide for surgery Way. 33. The method of claim 32, The step of designing a guide for recovery based on the obtained patient medical image data, Directly from the acquired patient medical image data or by acquiring virtual surgical data from the acquired patient medical image data to design a recovery guide therefrom. 33. A surgical guide manufactured according to the method of claims 26 to 32. A recovery guide made according to the method of claim 33 . In the surgical guide designed based on the obtained patient medical image data including at least the surgical site, at least one first display unit used to display a first reference point for positioning the surgical guide on the surgical site; a second display unit used to display a second reference point for implant insertion into the surgical site prior to surgery; a third display unit used to display a third reference point for fixing the implant to the surgical site during surgery; and A mesh structure connecting the at least one first display unit, the second display unit, and the third display unit to each other, and comprising a surgical guide body covering the surgical site as a whole. 37. The method of claim 36, The surgical guide designed based on the obtained patient medical image data, Directly from the acquired patient medical image data, or by acquiring virtual surgery data from the acquired patient medical image data, the surgical guide, characterized in that designed therefrom. 38. The method of claim 37, At least one of the first to third display units is a guide for surgery, characterized in that it has the shape of a groove or a wedge. 39. The method of claim 38, In each of the second display unit or the third display unit, after the display of the second reference point or the third reference point by the display means, to facilitate separation of the surgical guide from the surgical site where the display means is present. A guide for surgery, characterized in that the hole is further provided. 40. The method according to any one of claims 36 to 39, The surgical guide is a guide for nose plastic surgery, In this case, the first reference point is determined based on the patient's eye, the second reference point is determined based on the starting point of the implanted prosthesis, and the third reference point is determined based on the nostril point, surgical guide. 41. The method of claim 40, The designed surgical guide, 3D printing, cutting, injection, mold, surgical guide, characterized in that produced using at least one of vacuum molding.

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