KR102203493B1 - Patient-Specific 3D Printing Hybrid Plates - Google Patents

Abstract

The present invention relates to a patient-customized 3D printing hybrid plate, and more particularly, a cover plate in the form of an absorbable mesh capable of inducing bone union through bone conduction while covering a bone defect, and a fracture while fixing the cover plate. It includes a fixing plate that provides physical support for fixing and fusion of the pieces. The cover plate and the fixed plate are configured so that the shape of the portion in contact with the bone is complementary to the anatomical shape of the bone through 3D virtual surgery and 3D printing before surgery, so that the surgeon can use the plate in the operating room. As it becomes possible to omit a separate processing process such as bending or reshaping the shape, it is possible to predict more objectively regardless of who the surgeon is and to continuously expect accurate surgical results above a certain level. Accordingly, the operation time can be shortened, the patient's pain is reduced, the success rate of the operation is increased, the recovery period of the patient is shortened, the complications of the operation can be minimized to prevent complications, and the fractures and single-sided fractures accompanied by bone defects It relates to a patient-customized 3D printing hybrid plate that ultimately lowers the overall cost of surgery by simultaneously promoting stable fixation, support and bone union of the patient.

Description

Patient-Specific 3D Printing Hybrid Plates {Patient-Specific 3D Printing Hybrid Plates}

The present invention relates to a patient-customized 3D printing hybrid plate, and more particularly, a cover plate in the form of an absorbable mesh capable of inducing bone union through bone conduction while covering a bone defect, and a fracture while fixing the cover plate. It includes a fixing plate that provides physical support for fixing and fusion of the pieces. The cover plate and the fixed plate are configured so that the shape of the portion in contact with the bone is complementary to the anatomical shape of the bone through 3D virtual surgery and 3D printing before surgery, so that the surgeon can use the plate in the operating room. As it becomes possible to omit a separate processing process such as bending or reshaping the shape, it is possible to predict more objectively regardless of who the surgeon is and to continuously expect accurate surgical results above a certain level. Accordingly, the operation time can be shortened, the patient's pain is reduced, the success rate of the operation is increased, the recovery period of the patient is shortened, the complications of the operation can be minimized to prevent complications, and the fractures and single-sided fractures accompanied by bone defects It relates to a patient-customized 3D printing hybrid plate that ultimately lowers the overall cost of surgery by simultaneously promoting stable fixation, support and bone union of the patient.

The facial bone (facial bone) is the bone that forms the basis of the face among the skulls (head bones), the zygomatic bone (zygomatic bone, a), the maxilla (upper jaw, Maxilla.b), and the mandible (lower jaw bone). , Mandible, c), Lacrimal bone (d), Fibula (Nasal bone, e), Seogol (Moisturizing bone, Vomer, f), Inferior nasal concha (Inferior nasal concha, g) ). 1 is a view showing the position of each bone constituting the facial bone.

In the facial bone, a fracture may occur in which the continuity of bone tissue is destroyed by trauma or the like. Types of fractures include, depending on the condition of the wound, a compound fracture that may damage the surrounding tissues and infect the surrounding tissues, and a simple fracture that does not cause damage and infection to the surrounding tissues. Depending on the type of fracture, there are Complete fracture, Incomplete fracture, and Comminuted fracture, and depending on the direction of the fracture line, Linear fracture, Longitudinal fracture, and oblique line These include oblique fractures and spiral fractures. Most of the fractures that occur in the facial bone are compound fractures, in which not only bone tissue but also blood vessels, nerves, and muscles around the bone are simultaneously damaged, and comminuted fractures in which the bone is broken into several fractures. many.

FIG. 2 is a view showing the mandibular bone of a patient with comminuted fractures. Referring to FIG. 2, when comminuted fractures occur in the patient's facial bone by some external force, a plurality of fracture lines (L) are generated on the patient's facial bone. . These fracture lines (L) can cross each other while having an atypical shape, and the fracture fragment (F) whose outer periphery is surrounded by the fracture line (L) by the crossed fracture line (L) has no point of bonding with the surrounding bone tissue. As it becomes, it can fall away from surrounding bone tissue. As a result, a bone defect (D), which is an empty space created by a fracture fragment (F) separated from the bone tissue, is formed on the bone tissue of a patient with a comminuted fracture. Hereinafter, the fracture line (L) and the bone defect (D) will be divided into these concepts and described.

There is currently no treatment for bone defects that accompany the contact surface at the time of fixation of osteotomy after cosmetic purposes such as double jaw surgery and cheekbone reduction surgery, and bone defects that can be caused by facial bone fractures ( As a method of treating D), a method of covering a porous titanium mesh on the bone defect (D) or performing an overlay bone graft may be used. However, when inducing bone growth and healing with a porous titanium mesh,

By causing adhesion of the facial soft tissue in contact with the fibrous tissue of the bone union, the face may become unnatural when making facial expressions, or facial deformation may occur. In the case of overlapping bone graft, the donor who collected bone for bone graft There is a problem that the sacrifice of the donor is inevitable, such as surgery and disease occurrence of the donor. Therefore, in recent years, the use of the fixed plate 91 that holds the bones on both sides around the fracture line L so that the bones on both sides are not separated, or the cover plate 95 that promotes spontaneous bone growth while covering the bone defect (D) Is increasing.

3 is a view showing a conventional fixing plate 91. The prior art is disclosed in Korean Patent Laid-Open Publication No. 10-2016-0019245 (2016.02. 19), and FIG. 4 is an image of a fracture line of a patient with a fracture. It is a view showing a state in which the fixing plate 91 is performed. 3 and 4, when a fracture occurs on the facial bone of a patient due to various causes, in the prior art, the fracture line (L) is attempted to open through the fixing plate 91 and the fixing means 93. The fractured bones were joined by holding and fixing the fractured fragments (F) on both sides. A plurality of fixing holes 911 may be formed on the fixing plate 91 from one surface of the fixing plate 91 to the other surface, and the fixing means 93 may be inserted into the fixing hole 911 to It was settled on the goal.

However, there is a problem in that the conventional fixing plate 91 is uniformly manufactured and supplied according to a certain standard. Since the fixation plate 91 is not customized for the patient, in order to couple the fixation plate 91 to the affected part of the patient where the fracture has occurred, first, a surgeon judges that it is most appropriate among the standardized fixation plates 91 After selecting the fixed plate 91, it undergoes a processing process such as bend or shape to fit the affected part of the patient. Eventually, the fixed plate 91 prepared through such a rough processing process could not properly reflect the patient's anatomical shape. When the fixed plate 91 is coupled to the affected part of the patient, as shown in FIG. , A space (S) was generated between the bone (B) and the fixing plate 91 coupled to the bone (B) by the fixing means (93).

Whether the fixing plate 91 can have a shape complementary to the anatomical shape of the patient's bone depends entirely on whether the surgeon can accurately process the fixing plate 91 according to the patient's bone shape. Therefore, the conventional fixed plate 91 may cause a problem in which the surgical result is different depending on the skill level and experience of the surgeon, and the operation inevitably caused some errors, unlike previously planned.

In addition, the surgeon in the operating room roughly bends the fixed plate 91 to fit the shape of the patient's bone, depending on his own experience and senses, and brings it closer to the patient's bone to reshape it if it still does not fit. The back was repeated, which in turn caused the problem that the results of surgery were different depending on the surgeon, and acted as a cause of increasing the operation time, and the patient's pain increased with the increase of the operation time, and the risk of surgery was increased. It was higher than that, resulting in an increase in various costs required to proceed with the operation, and the occurrence of postoperative complications and the frequency of reoperation increased.

6 is a view showing a conventional cover plate 95, which is disclosed in US 2005/0149032A1. Referring to the contents shown in FIG. 6, when a bone defect (D) occurs due to a fracture, a cover plate 95 forming a predetermined surface is provided to cover the bone defect (D). This cover plate 95 is preferably formed of an absorbent material and configured to be decomposed after surgery, and has a feature that a plurality of through holes 951 are provided to promote bone growth.

However, as shown in FIG. 6, the conventional cover plate 95 was also not manufactured to be customized for the patient, but was manufactured in a factory to a certain standard and then implanted on the affected part of the patient through a cutting process according to the needs of the surgeon. , The problem caused by the conventional fixing plate 91 has occurred as it is.

In particular, since the cover plate 95 forms a surface of a certain size, it has a two-dimensional shape of the cover plate 95 and implements a three-dimensional shape of the patient's facial bone having various curvatures for each part. It was even more difficult. What the surgeon can do to implement the two-dimensional cover plate 95 in a three-dimensional shape is the degree to which the plate 95 is bent by creating a cutting area 953 as shown in FIG. 6 or by applying an external force. Because it was.

In the end, in the case of the conventional cover plate 95, the surgical result was inevitably dependent on personal and subjective requirements such as the surgeon's skill and experience, and the deviation of the surgical result was severe, and in the process of processing the cover plate 95 A lot of time was spent, causing greater pain to the patient as the operation time increased, increasing the risk of surgery, increasing the operation cost, increasing the frequency of complications after surgery, and causing various problems such as reoperation.

In addition, since the existing cover plate has the property of being absorbed after a certain period of time, it has been difficult to use it alone in areas that require consistently high strength physical support and fixation between fracture and fracture segments. Since the conventional fixed plate 91 and the cover plate 95 were handled separately and used for the procedure, the surgeon had to keep all of the plates, and because they had to be brought to the operating room and individually processed and then transplanted. , Making the management and use process very cumbersome.

Therefore, a patient-specific plate having a shape complementary to the patient's anatomical shape by 3D printing, including both the physical fixation and support force of the fixed plate 91 and bone conduction for filling the bone defect of the cover plate 95 By making it possible to omit a separate processing process by the surgeon in the operating room, it is possible to predict more objectively regardless of who the surgeon is and to continuously expect accurate surgical results above a certain level. It shortens the patient's pain, increases the success rate of the operation, shortens the patient's recovery period, minimizes the complications of the operation, and prevents complications, and the stable fixation of fractures and one side of osteotomy accompanied by bone defects, It is a situation in which the introduction of a new technology is required to ultimately lower the overall cost of surgery by simultaneously promoting support and bone union.

Korean Patent Application Publication No. 10-2016-0019245 (2016.02.19) US published patent publication US2005/0149032A1 (2005.07.07)

The present invention was devised to solve the above problems,

An object of the present invention is a cover plate for inducing bone conduction of the bone defect and at the same time covering the bone defect, and a fixing plate for simultaneously fixing the cover plate and the fracture fragment and providing physical fixation and support, and the cover The plate and the fixed plate are constructed using 3D printing based on 3D virtual surgery so that the shape of the portion in contact with the bone has a shape that is complementary to the anatomical shape of the bone, thereby bending the plate by a surgeon in the operating room or As it becomes possible to omit a separate processing process such as reshaping the shape, it is possible to predict more objectively and continuously expect accurate surgical results above a certain level, regardless of who the surgeon is, and shorten the operation time. It reduces patient's pain, increases the success rate of surgery, shortens the patient's recovery period, minimizes complications of surgery, and prevents complications, and provides stable fixation, support and bone union of fractured fractures and one side of osteotomy with bone defects. At the same time, it is to provide a patient-customized 3D printing hybrid plate that can ultimately lower the overall cost of surgery.

Another object of the present invention is that the cover plate is configured such that at least a portion of the cover plate is in contact with the fixing plate, so that the cover plate and the fixing plate can be coupled, thereby ensuring stabilization and support between fracture fragments, It is to provide a patient-specific 3D printing hybrid plate that can promote bone formation in a bone defect.

Another object of the present invention is that the cover plate and the fixed plate are configured to be integrally manufactured to the patient by 3D printing, so as to reduce the trouble of manufacturing and combining the cover plate and the fixed plate, respectively, and the integrally manufactured hybrid plate By allowing the patient to accurately match the previously planned patient's affected area, the operation time is drastically shortened, the bone defect is prevented from being neglected, and the continuity and stability of the fractured fracture is ensured, while osteoconduction It is to provide a 3D printed hybrid plate tailored to the patient.

Another object of the present invention is that the cover plate and the fixed plate are configured to be individually manufactured and coupled to each patient by 3D printing, so that when the cover plate and the fixed plate are integrally manufactured, both can be made of different materials. The problem is to provide a patient-customized 3D printing hybrid plate that allows the cover plate and the fixed plate to be composed of different materials by using a method of separately manufacturing and combining each by 3D printing.

Another object of the present invention is that the cover plate is composed of an absorbent plate, and the fixed plate is composed of a non-absorbable plate, thereby filling the bone defects by the cover plate composed of an absorbent plate and promoting the patient's autogenous bone growth It eliminates the separate surgical procedure for removing the cover plate by allowing it to be naturally absorbed into the body after surgery, and the fracture fragments separated around the fracture line by the fixed plate composed of a non-absorbable plate are not separated from each other but are strongly held and securely fixed. To provide patient-specific 3D printing hybrid plates.

Another object of the present invention is that the cover plate includes a coupling part, and the fixed plate comprises a fastening part, so that the cover plate and the fixed plate are individually manufactured and combined to a patient by 3D printing, It is to provide a patient-customized 3D printing hybrid plate that allows the cover plate and the fixed plate to be strongly, accurately and closely coupled through the coupling portion and the fastening portion.

Another object of the present invention is that the cover plate is formed in a shape complementary to the shape of the missing bone and is configured to be seated on the bone defect, so that the cover plate having the same shape as the shape of the lost bone is It is to provide a patient-customized 3D printing hybrid plate that is inserted on the defect to promote bone growth, so that the patient's facial shape can be similar to the patient's original facial shape before the facial bone fractures even after surgery.

Another object of the present invention is that the cover plate is composed of a porous material including a plurality of pores in the contact surface of the bone defect and the facial support ligament, so that the patient's spontaneous bone growth can be promoted between the pores. At the same time, by securing support and fixation force, it is to provide a patient-customized 3D printing hybrid plate that can prevent the sacrifice of the donor from which bone is collected as bone graft is not required.

Another object of the present invention is that the fixing plate comprises a body part constituting a body, and a fixing hole formed to pass through the other surface from one side of the body part to receive the fixing means, so that the facial nerve and In order to prevent unexpected damage to the blood vessel area, and to prevent adhesion due to unnecessary fibrosis on the contact surface of the face other than the bone defect and the facial support ligament, the fixed plate combined with the cover plate is It is to provide a patient-customized 3D printing hybrid plate that promotes bone conduction while preventing the deformation of the facial part that may occur due to unnecessary fibrosis and adhesion after surgery by fixing the nerve and blood vessels that may occur during surgery.

The present invention is implemented by an embodiment having the following configuration in order to achieve the above object.

According to an embodiment of the present invention, the present invention includes a cover plate covering a bone defect and a fixing plate fixing the cover plate, wherein the cover plate and the fixing plate have a shape of a portion in contact with the bone It is characterized by having a shape complementary to the anatomical shape of the bone.

According to another embodiment of the present invention, the cover plate is characterized in that at least a portion of the cover plate contacts the fixed plate.

According to another embodiment of the present invention, the present invention is characterized in that the cover plate and the fixed plate are integrally manufactured to be customized for a patient by 3D printing.

According to another embodiment of the present invention, the present invention is characterized in that the cover plate and the fixed plate are individually manufactured and combined to be customized for a patient by 3D printing.

According to another embodiment of the present invention, the cover plate is characterized in that the absorbent plate.

According to another embodiment of the present invention, the present invention is a polymer, ceramic, and other biocompatible materials, which are all absorbable biocompatible materials that are currently permitted for insertion into the human body after completion of biocompatibility evaluation. Calcium phosphate compound biomaterial, PLLA (Poly-L-lactide), PDLLA (Poly-DL-lactide), PDLLA and PGA (Polyglycolic acid), uHA (unsintered Hydroxyapatite particles) and PLLA, PLLA or It is characterized in that it is any one of PDLLA and TMC (Trimethylene carbonate) or PGA (Polyglycolic acid) and β-TCP (Beta-tricalcium phosphate).

According to another embodiment of the present invention, the present invention is characterized in that the fixing plate is a non-absorbent plate.

According to another embodiment of the present invention, the present invention is characterized in that the non-absorbent plate is a titanium plate.

According to another embodiment of the present invention, the cover plate includes a coupling portion formed at a portion in contact with the fixed plate to couple the cover plate to the fixed plate, and the fixed plate includes the cover plate The cover plate and the fixing plate are coupled to each other by the coupling portion and the coupling portion, including a coupling portion formed on a position corresponding to the coupling portion of the coupling portion and fastened to the coupling portion.

According to another embodiment of the present invention, the cover plate is formed in a shape complementary to the shape of the missing bone, and is seated on the bone defect.

According to another embodiment of the present invention, the cover plate is characterized in that it is formed of a porous material including a plurality of voids on the bone defect contact surface and the facial support ligament contact surface.

According to another embodiment of the present invention, the cover plate is characterized in that the contact surface of the facial part other than the contact surface of the bone defect and the support ligament of the facial part is formed of a non-porous material, and is integrated with a porous material according to the part. Or it is characterized in that it is formed as a standalone.

The present invention can obtain the following effects by the configuration, combination, and use relationship that will be described below with the present embodiment.

The present invention includes a cover plate for inducing bone conduction of the bone defect and at the same time covering the bone defect, and a fixing plate for simultaneously fixing the cover plate and the bone fragment and providing physical fixation and support, and the cover plate and The fixed plate is constructed using 3D printing based on 3D virtual surgery so that the shape of the portion in contact with the bone has a shape that is complementary to the anatomical shape of the bone, so that the plate is bent or shaped by a surgeon in the operating room. As it becomes possible to omit a separate processing process such as refining, it is possible to predict more objectively regardless of who the surgeon is and to be able to continuously expect accurate surgical results above a certain level, shorten the operation time, and It reduces pain, increases the success rate of surgery, shortens the patient's recovery period, minimizes the complications of surgery, and prevents complications, and promotes stable fixation, support and bone union of fractured fractures and one side of osteotomy with bone defects. By doing so, it has the effect of providing a patient-customized 3D printing hybrid plate that can ultimately lower the overall cost of surgery.

In the present invention, the cover plate is configured such that at least a portion of the cover plate is in contact with the fixed plate, so that the cover plate and the fixed plate can be coupled, thereby securing stabilization and support between fracture fragments, and at the same time The effect of providing a patient-specific 3D-printed hybrid plate that can promote bone formation of the patient is derived.

In the present invention, the cover plate and the fixed plate are configured to be integrally manufactured to the patient by 3D printing, reducing the trouble of manufacturing and combining the cover plate and the fixed plate, respectively, and the integrally manufactured hybrid plate is planned in advance. By allowing the patient to accurately match the affected area, the operation time is drastically shortened, the bone defect area is prevented from being left unattended, and while securing the continuity and stability of the fractured fracture fragment, it promotes osteoconduction. There is an effect of providing a patient-customized 3D printing hybrid plate.

In the present invention, the cover plate and the fixed plate are configured to be individually manufactured and coupled to each patient by 3D printing, so that when the cover plate and the fixed plate are integrally manufactured, both can not be made of different materials, By using a method of separately manufacturing and combining each of them by 3D printing, it has the effect of providing a patient-customized 3D printing hybrid plate that allows the cover plate and the fixed plate to be composed of different materials.

In the present invention, the cover plate is composed of an absorbent plate, and the fixed plate is composed of a non-absorbable plate, thereby filling the bone defect by the cover plate composed of an absorbent plate, promoting the patient's spontaneous bone growth, and natural after surgery. Patients that eliminate the separate surgical procedure for removing the cover plate by allowing it to be absorbed into the body, and ensure that the fracture fragments separated around the fracture line by a fixed plate composed of a non-absorbable plate are strongly held together and can be stably fixed. It derives the effect of providing a customized 3D printing hybrid plate.

In the present invention, the cover plate includes a coupling portion, and the fixing plate includes a fastening portion, so that the cover plate and the fixed plate are individually manufactured and coupled to each patient by 3D printing. There is an effect of providing a patient-customized 3D printing hybrid plate that allows the cover plate and the fixed plate to be strongly, accurately and closely coupled through the fastening part.

In the present invention, the cover plate is formed in a shape complementary to the shape of the bone defect and is configured to be seated on the bone defect, so that a cover plate having the same shape as the shape of the bone defect is formed on the bone defect. It has the effect of providing a patient-customized 3D printing hybrid plate that allows the patient's facial shape to be similar to the patient's original facial shape before the facial bone fractures even after surgery by being inserted to promote bone growth.

In the present invention, the cover plate is composed of a porous material including a plurality of pores in the contact surface of the bone defect and the facial support ligament, so that the patient's spontaneous bone growth can be promoted between the pores and at the same time support and fixation force By securing, as the bone graft is not required, the effect of providing a patient-customized 3D printing hybrid plate that can prevent the sacrifice of the donor from which bone is collected is derived.

In the present invention, the fixing plate is configured to include a body part constituting a body, and a fixing hole formed to pass through the other surface from one side of the body part to receive the fixing means, so as to predict the nerve and blood vessel parts of the facial part customized to the patient. In order to prevent unsatisfactory damage, and to prevent adhesion due to unnecessary fibrosis on the contact surface of the face other than the bone defect and the facial support ligament, the fixed plate combined with the cover plate is fixed to the patient's bone through non-porous surface treatment. By doing so, there is an effect of providing a patient-customized 3D printing hybrid plate that promotes bone conduction while preventing deformation of the facial part that may occur due to nerve and blood vessel damage that may occur during surgery and unnecessary fibrosis and adhesion after surgery.

1 is a view showing the position of each bone constituting the facial bone.
2 is a view showing the mandibular bone of a patient with comminuted fracture.
Figure 3 is a view showing a conventional fixing plate.
4 is a view showing a state in which a fixed plate is operated on a fracture line of a patient with a fracture.
5 is a view showing that a space is generated between the fixed plate and the bone of the patient.
Figure 6 is a view showing a conventional cover plate.
7 is a perspective view of a patient-customized 3D printing hybrid plate according to an embodiment of the present invention.
Figure 8 is an exploded perspective view of Figure 7;
9 is a view showing a cover plate according to an embodiment of the present invention.
10 is a view showing an embodiment in which a cover plate covers a bone defect.
11 is a view showing another embodiment in which the cover plate covers the bone defect.
12 is a view showing another embodiment in which the cover plate covers the bone defect.
13 is a view showing the facial support ligaments.
14 is a view showing an embodiment in which the shape of the contact portion of the cover plate has a shape complementary to the anatomical shape of the bone.
15 is a view showing another embodiment in which the shape of the contact portion of the cover plate has a shape complementary to the anatomical shape of the bone.
16 is a view showing another embodiment in which the shape of the contact portion of the cover plate has a shape complementary to the anatomical shape of the bone.
17 is a view showing a cover plate in which a coupling portion is formed according to another embodiment of the present invention.
18 is a view showing a cover plate in which a nerve receiving part is formed according to another embodiment of the present invention.
Fig. 19 is a view showing the rear surface of Fig. 18;
20 is a view showing a cover plate in which a nerve receiving part is formed according to another embodiment of the present invention.
Fig. 21 is a view showing the rear surface of Fig. 20;
22 is a view showing a fixing plate according to an embodiment of the present invention.
23 is a view showing an embodiment in which the shape of a portion of the fixed plate in contact with the bone has a shape complementary to the anatomical shape of the bone.
24 is a view showing a fixing plate in which a fastening part is formed according to another embodiment of the present invention.
Fig. 25 is a sectional view taken along line A-A' of Fig. 24;
26 is a view showing that the coupling portion of the fixing plate and the coupling portion of the cover plate are coupled.
Figure 27 is a state diagram of the present invention.

Hereinafter, preferred embodiments of the patient-customized 3D printing hybrid plate according to the present invention will be described in detail with reference to the accompanying drawings. In the following description of the present invention, if it is determined that a detailed description of a known function or configuration may unnecessarily obscure the subject matter of the present invention, a detailed description thereof will be omitted. Unless otherwise defined, all terms in this specification are the same as the general meanings of the terms understood by those of ordinary skill in the art to which the present invention belongs, and in case of conflict with the meanings of terms used in the present specification, the present disclosure According to the definitions used in the specification.

In this specification, the fracture line (L), the fracture fragment (F), and the bone defect (D) are repeatedly described, and the fracture line (L) is a line that separates the bone when the patient's facial bone is broken due to trauma. The fracture fragment (F) refers to bone fragments separated by the fracture line (L), and the bone defect (D) refers to the fracture fragment (F) by the intersection of the fracture line (L). It refers to an empty space in the bone tissue created by a fracture fragment (F) that has been separated from the surrounding bone tissue as it loses the point to be joined with.

7 is a perspective view of a patient-customized 3D printing hybrid plate according to an embodiment of the present invention, and FIG. 8 is an exploded perspective view of FIG. 7. Referring to FIGS. 7 and 8, the patient-customized 3D printing hybrid plate 1 of the present invention is manufactured to have a shape complementary to the patient's anatomical shape, so that a separate processing process by the surgeon in the operating room is omitted. As a result, the surgeon can more objectively expect a certain level of surgical results regardless of who the surgeon is, shortens the operation time, reduces the patient's pain, increases the success rate of the operation, and prevents complications and reoperation. To block in advance and to reduce the overall cost of surgery, it may be preferably manufactured by 3D printing.

The surgeon takes a medical image such as CT or MRI of the patient's face with a fracture, implements the patient's facial bone in a three-dimensional shape on a computer based on the photographed data, and the patient to be used for surgery in the implemented three-dimensional shape. After undergoing 3D virtual surgery and modeling to determine the position, size, and shape of the customized 3D printing hybrid plate 1, the patient customized 3D printing hybrid plate 1 can be printed through a 3D printer. .

The patient-customized 3D printing hybrid plate (1) includes a cover plate (10) and a fixed plate (30), the cover plate (10) and the fixed plate (30) are integrally manufactured to the patient by 3D printing It can be made and combined with each patient customized by 3D printing. For this, it is preferable that the cover plate 10 is configured such that at least a portion of the cover plate 10 comes into contact with the fixing plate 30.

9 is a view showing a cover plate according to an embodiment of the present invention, and will be described below with reference to FIG. 9.

The cover plate 10 is configured to induce bone conduction of the bone defect portion D while covering the bone defect portion D, and by covering the portion where the bone defect occurs due to the fracture with the cover plate 10 , It promotes spontaneous bone growth in the bone defect (D) so that the bone defect (D) can be restored. Regarding the meaning of the covering, referring to FIGS. 10 to 12, the cover plate 10 may be formed to cover only a part of the bone defect D as shown in FIG. 10. As shown in FIG. 11, it may be formed to have an area larger than the area of the bone defect (D) to cover the entire area of the bone defect (D), as shown in FIG. Likewise, it is preferable to see it as a concept in a broad sense that includes all cases in which the shape of the bone defect is complementary to the shape of the bone and is seated on the bone defect (D). The cover plate 10 includes a contact portion 11, a non-contact portion 13, a coupling portion 15, and a nerve receiving portion 17.

The contact portion 11 is a portion of the cover plate 10 in contact with the bone or facial support ligaments, and is formed of a porous material. 13 is a view showing the supporting ligaments of the facial part, and referring to FIG. 13, as shown, the facial part of a human is distributed subcutaneous fat (SF) by parts on the face, and between the subcutaneous fat (SF) by parts The supporting ligament (G) for supporting it is positioned as shown. Therefore, the cover plate 10 covering the bone defect (D) may be in contact with the bone, but may also contact the facial support ligament (G). The contact portion 11 of the cover plate 10, which is in contact with the bone or facial support ligaments, should promote bone regeneration through bone conduction and at the same time secure support and fixation, and is preferably formed of a porous material. Such a contact part 11 includes a void 11a.

The void 11a refers to a hole formed on the contact portion 11 of the cover plate 10, and a plurality of the voids 11a may exist on the cover plate 10. Through the cover plate 10, it should be possible to promote the growth of new bones in the bone defects D where the bones are empty. Preferably, the contact part 11 of the cover plate 10 has a plurality of voids ( By consisting of a porous material including 11a), a plurality of micropores 11a are formed on the cover plate 10, and the patient's own bones can rapidly grow between these minute pores 11a. .

The non-contacting portion 13 is a portion of the cover plate 10 that does not contact the bone or facial support ligaments, and is formed of a non-porous material. The non-contact part 13 on the cover plate 10 that does not contact bone or facial support ligaments (G) is a relatively smooth surface to prevent damage to blood vessels and nerves and to prevent unnatural facial deformation after surgery due to unnecessary fibrosis and adhesion. It is preferably formed of a non-porous material having a.

As shown in FIGS. 10 and 11 mentioned above, when the cover plate 10 is formed to cover part or all of the bone defect (D), the cover plate 10 is It is preferable that the shape is configured to have a shape complementary to the anatomical shape of the bone. 14 is a view showing an embodiment in which the shape of the contact portion 11 of the cover plate 10 has a shape complementary to the anatomical shape of a bone and is formed in a porous structure, and will be described with reference to FIG. 14, When the cover plate 10 is formed to cover the bone defect (D), a contact portion 11 is required to allow the cover plate 10 to be positioned on the bone defect (D). At this time, if the contact part 11 is not complementary to the anatomical shape of the outer circumferential surface of the patient's bone (B), the contact part 11 is not accurately coupled to the patient's bone (B), thereby forming an unnecessary space. And, such a space can act as a cause of deteriorating the bone growth efficiency by separating the cover plate 10 from the outer circumferential surface of the bone (B), the shape of the contact portion 11 of the cover plate 10 It is preferable to be configured to have a shape complementary to the enemy shape.

More preferably, as shown in FIG. 14, the non-contact portion 13 of the cover plate 10 is also configured to have a shape complementary to the outer circumferential shape of the lost bone, so that the cover plate 10 is implanted. Allow the patient to regain close to the original facial shape after surgery.

15 is a view showing another embodiment in which the shape of the junction of the cover plate has a shape complementary to the anatomical shape of a bone. In FIG. 15, it can be seen that the shape of the contact part 11 that comes into contact with the bone or facial support ligament is configured to be different from that of FIG. 14. In the embodiment of FIG. 14, the contact portion 11 is configured only in a simple plate-shaped shape, whereas in the embodiment of FIG. 15, the contact portion 11 has an approximately plate-shaped shape while providing irregularities on the opposite surface of the bone or facial support ligament. There is a difference. That is, the shape of the contact part 11 of the present invention is not limited to the plate shape as shown in FIG. 14, and as shown in FIG. 15, it may be configured in any number of various shapes.

FIG. 16 is a view showing another embodiment in which the shape of the contact portion of the cover plate has a shape complementary to the anatomical shape of the bone. As shown in FIG. 12, the shape of the missing bone When it is composed of a shape complementary to that and is seated on the bone defect (D), the contact part 11 of the cover plate 10 is formed of a porous material so as to promote bone regeneration and secure support and fixation force. It is preferable that the contact portion 11 in the embodiment of FIG. 16 is the end of the bone separated along the fracture line L, and thus may have a shape complementary to the end of the bone, as shown in FIG. 14. In this case, the non-contact part 13 of the cover plate 10 may be configured with a non-porous structure to minimize damage to soft tissues such as blood vessels, nerves, and muscles, and to prevent unnecessary fibrosis and deformation after surgery due to adhesion. , It is preferable to configure the same as the outer circumferential shape of the lost bone, so that the patient receiving the cover plate 10 can restore the original facial shape.

The material constituting the cover plate 10 is not limited to any specific concept, but may be preferably made of an absorbent plate. By making the cover plate 10 customized to the patient by 3D printing, the surgeon can skip processing such as bending the cover plate 10 in the surgical process, and the cover plate 10 is composed of an absorbent material. Therefore, an additional operation for removing the cover plate 10 after surgery may be omitted.

The absorbent plate refers to a plate composed of polymers, ceramics, or other biomaterials, which are all absorbable biocompatible materials that are currently permitted to be inserted into the human body after completion of the absorption biocompatibility evaluation, and preferably ① Calcium phosphate compound biomaterial, ② PLLA (Poly-L-lactide), ③ PDLLA (Poly-DL-lactide), ④ PDLLA (Poly-DL-lactide) and PGA (polyglycolic acid), ⑤ uHA (unsintered Hydroxyapatite particles) and PLLA (Poly-L-lactide), ⑥ TMC (Trimethylene carbonate), ⑦ PLLA (Poly-L-lactide) and TMC (Trimethylene carbonate), ⑧ PDLLA (Poly-DL-lactide) It may include trimethylene carbonate (TMC) and ⑨ polyglycolic acid (PGA) and beta-tricalcium phosphate (β-TCP).

The coupling portion 15 is formed in a portion in contact with the fixed plate 30 to couple the cover plate 10 to the fixed plate 30. As described above, the present invention is a hybrid plate in which the cover plate 10 and the fixing plate 30 are combined, and in order to include both the cover plate 10 and the fixing plate 30, at least of the cover plate 10 A portion needs to be configured to contact the fixed plate 30, and this contact may be made by integrally manufacturing the cover plate 10 and the fixed plate 30 by 3D printing, or by 3D printing. 10) and the fixing plate 30 can be made by combining both. The coupling portion 15 may be viewed as a configuration formed on the cover plate 10 under the purpose of coupling the separately manufactured cover plate 10 and the fixing plate 30 to each other. The content shown in FIG. 17 corresponds to an embodiment of the coupling portion 15, and the coupling portion 15 is not limited to this embodiment, and as long as it can perform the above-described purpose, variously Can be configured.

18 is a view showing a cover plate in which a nerve receptor is formed according to another embodiment of the present invention, FIG. 19 is a view showing the rear surface of FIG. 18, and FIG. 20 is a view showing a nerve according to another embodiment of the present invention. It is a view showing the cover plate in which the receiving portion is formed, and FIG. 21 is a view showing the rear surface of FIG. 20, and hereinafter, reference will be made to FIGS. 18 to 21.

The nerve receiving part 17 refers to a portion on the cover plate 10 that provides a space for receiving facial nerves. Preferably, the nerve receiving unit 17, as shown in Figs. 18 to 21, the nerves on the cover plate 10 so that the nerves are not pressed or damaged by the cover plate 10. It refers to a portion recessed to a predetermined depth so as not to interfere. More preferably, as described above, the contact portion 11 of the cover plate 10 may be made of a porous material having a rough surface. In order to prevent nerve damage by such a rough surface, it faces the nerve. The facing surface of the nerve receiving part 17 in contact may be made of a non-porous material. 18 and 19 show an embodiment in which a receiving space recessed inward is formed on the upper side of the cover plate 10 so that the suborbital nerve can escape, and the cases of FIGS. 20 and 21 are When the cover plate 10 covers the part where the nerve is driven, it is inserted upward on the lower side of the cover plate 10 so that the facial nerve is not compressed or damaged by the cover plate 10 to create a concave space. The formed embodiment is shown.

22 is a view showing a fixing plate according to an embodiment of the present invention, which will be described below with reference to FIG. 22.

The fixing plate 30 refers to a configuration for fixing the cover plate 10. In addition, the fixing plate 30 may have a function of fixing the bones separated by the fracture line L so that they do not separate from each other. Since the cover plate 10 as well as the fixed plate 30 are also coupled to the patient's bone, the shape of the portion in contact with the bone is preferably configured to have a shape complementary to the anatomical shape of the bone. . According to the contents shown in Fig. 22, the fixing plate 30 has a sharply curved shape, and the fixing plate 30 of the present invention secures such fixing power and support so as to stably fix and support the fracture fragment that needs to be fixed. Since it must be positioned at a position that can be done, it shows that it may have a shape as shown in FIG. 22 in some cases, and the fixing plate 30 is not necessarily limited to this shape.

23 is a view showing an embodiment in which the shape of a portion of the fixed plate in contact with the bone has a shape that is complementary to the anatomical shape of the bone. Referring to FIG. 23, the patient's bone forms various curvatures and is atypical. By reflecting this anatomical shape as it is and manufacturing the fixed plate 30 by 3D printing, the surgeon brings the fixed plate 30 prepared in the operating room to the affected part of the patient without a separate processing process. With just that, it is possible to accurately place the fixed plate 30 on the patient's bone immediately, and unnecessary spaced space between the patient's bone (B) and the contact surface (30a) of the fixed plate 30 may not be generated. There will be.

More preferably, the other surface (30b) of the portion (30a) in contact with the bone of the fixing plate (30) is also configured in a shape that is complementary to the anatomical shape of the patient's bone, so that the fixed plate (30) is implanted. Allows the face to be restored to resemble its original shape.

The material of the fixing plate 30 is not limited to any specific concept, but preferably the fixing plate 30 has a function of strongly holding the bones of both sides spaced around the fracture line L so that they do not fall apart from each other. In that sense, it may be desirable to configure the fixing plate 30 as a non-absorbent plate so that a predetermined strength can be secured. More preferably, the non-absorbent plate may be a titanium plate.

24 is a view showing a fixing plate in which a fastening part is formed according to another embodiment of the present invention. When described with reference to FIG. 24, the fixing plate 30 includes a body part 31 and a fixing hole 33 , Including the fastening portion 35.

The body part 31 refers to a configuration constituting a body in the fixing plate 30. As shown in FIG. 24, the body portion 31 may be configured in a form in which disk-shaped nodes are arranged at arbitrary intervals and connected to them, but this corresponds to an embodiment of the body portion 31. As such, the body portion 31 is not necessarily limited to this concept, and may be configured in any number of ways.

The fixing hole 33 is formed to penetrate from one surface of the body part 31 to the other surface, and the fixing plate 30 is attached to the patient so that the fixing plate 30 can be firmly fixed on the bone of the patient. It refers to the part where the fixing means (P) for fastening with the bone is inserted. Accordingly, a plurality of the fixing holes 33 may be formed on the body part 31, and the fixing holes 33 are preferably configured in a form capable of accommodating the fixing means P.

The fastening part 35 is formed on a position corresponding to the coupling part 15 of the cover plate 10 and is fastened to the coupling part 15. FIG. 25 is a cross-sectional view taken along line A-A' of FIG. 24, and referring to FIG. 25, as described above, the cover plate 10 and the fixed plate 30 are separately manufactured to be customized for a patient by 3D printing. The coupling portion 15 may be configured on the cover plate 10 for such coupling, and the coupling portion 35 may be coupled to the coupling portion 15. The contents shown in FIG. 24 show an embodiment of the fastening part 35, and the fastening part 35 is not necessarily configured as shown, and the coupling part 15 of the cover plate 10 Anything that can be concluded with can be configured in any number of ways. Referring to FIG. 26, if the coupling portion 15 of the cover plate 10 is configured in the shape of a protruding protrusion as shown, the coupling portion 35 of the fixing plate 30 accommodates such a protrusion. It can be configured in a form that can be done. In order to do so, of course, the position of the coupling portion 15 of the cover plate 10 and the position of the coupling portion 35 of the fixing plate 30 must correspond to each other. In addition, the coupling portion 15 and the fastening portion 35 may be configured in plural to increase the coupling force between the cover plate 10 and the fixing plate 30.

27 is a state diagram of use of the present invention. Referring to FIG. 27, when a fracture occurs in the patient's facial bone due to trauma, etc., the surgeon acquires the patient's facial bone data using CT, MRI, etc., and implements it in three dimensions on a computer, The plate required for facial bone surgery is designed with a three-dimensional shape. When modeling of the plate is completed according to the surgery plan, the plate is printed using a 3D printer, through which a patient-customized 3D printing hybrid plate 1 is created. The surgeon can integrally manufacture the patient-customized 3D printing hybrid plate 1 in which the cover plate 10 and the fixed plate 30 having a shape complementary to the shape of the patient's bone can be integrally manufactured, as well as manufacturing each separately. You can also combine them. The patient-customized 3D printing hybrid plate (1) made through such a process eliminates the need for processing such as bending the plate depending on the skill or experience of the surgeon in the operating room, so that regardless of who the surgeon is, a certain level more objectively. It enables the expectation of the above surgical results, shortens the operation time, reduces the patient's pain, increases the success rate of surgery, prevents complications and reoperation in advance, and reduces the overall cost of surgery.

The detailed description above is illustrative of the present invention. In addition, the above description shows and describes preferred embodiments of the present invention, and the present invention can be used in various other combinations, modifications and environments. That is, changes or modifications may be made within the scope of the concept of the invention disclosed in the present specification, the scope equivalent to the disclosed contents, and/or the skill or knowledge of the art. The above-described embodiments describe the best state for implementing the technical idea of the present invention, and various changes required in the specific application fields and uses of the present invention are possible. Therefore, the detailed description of the invention is not intended to limit the invention to the disclosed embodiment. In addition, the appended claims should be construed as including other embodiments.

1: Patient-specific 3D printed hybrid plate
10: cover plate 11: contact portion
11a: void 13: non-contact portion
15: coupling portion 17: nerve receptor
30: fixed plate 31: body
33: fixing hole 35: fastening part
L: fracture line F: fracture fragment
D: bone defect P: fixing means

Claims (12)

It includes a cover plate covering the upper side of the bone defect and inducing bone conduction of an empty space in the bone defect located at the lower side, and a cover plate and a fixing plate for fixing the bone fragment
The cover plate and the fixed plate have a shape complementary to a shape of a bone in contact and a shape of an outer peripheral surface of the original shape of the bone defect by 3D printing,
The cover plate is an absorbent plate absorbed by the bone defect, and includes a contact portion formed of a porous material, and a non-contact portion formed of a non-porous material,
The contact portion is formed in a portion of the cover plate in contact with any one of a bone, a bone defect, and a facial support ligament,
The non-contact portion, characterized in that formed in a portion of the cover plate that does not contact any one of the bone, bone defect, and facial support ligaments,
Patient-specific 3D printed hybrid plates. According to claim 1, The cover plate, characterized in that at least a portion of the cover plate in contact with the fixed plate, patient customized 3D printing hybrid plate. The patient-customized 3D printing hybrid plate of claim 2, wherein the cover plate and the fixed plate are integrally manufactured to be patient-customized by 3D printing. According to claim 2, The cover plate and the fixed plate, characterized in that the combination of each of the patient-customized manufacturing by 3D printing, patient-customized 3D printing hybrid plate. delete The method of claim 1, wherein the absorbent plate is a calcium phosphate compound biomaterial, PLLA (Poly-L-lactide), PDLLA (Poly-DL-lactide), PDLLA (Poly-DL-lactide). And PGA (polyglycolic acid), uHA (unsintered Hydroxyapatite particles) and PLLA (Poly-L-lactide), TMC (Trimethylene carbonate), PLLA (Poly-L-lactide) and TMC (Trimethylene carbonate), PDLLA (Poly-DL- lactide) and TMC (Trimethylene carbonate), PGA (Polyglycolic acid) and β-TCP (Beta-tricalcium phosphate), characterized in that it comprises any one of, patient-customized 3D printing hybrid plate. According to claim 1, The fixed plate, characterized in that the non-absorbable plate, patient-customized 3D printing hybrid plate. According to claim 7, The non-absorbent plate, characterized in that the titanium plate, patient-customized 3D printing hybrid plate. The method of claim 4, wherein the cover plate comprises a coupling portion formed at a portion in contact with the fixed plate to couple the cover plate to the fixed plate, and the fixed plate is positioned at a position corresponding to the coupling portion of the cover plate. A patient-customized 3D printing hybrid plate, characterized in that the cover plate and the fixed plate are coupled by the coupling portion and the fastening portion, including a fastening portion formed in the coupling portion and fastened to the coupling portion. delete According to claim 1, The cover plate, characterized in that it further comprises a nerve receiving unit that provides a space in which nerves are accommodated, patient-customized 3D printing hybrid plate. The method of claim 1, wherein the fixing plate comprises a body part constituting a body, and a fixing hole formed to pass through the other surface from one surface of the body part to receive the fixing means. .

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