KR102359302B1 - Patient-specific pin guide for total knee arthroplasty including an anatomical theory-based lower extremity alignment check part - Google Patents

Abstract

The present invention relates to a patient-customized pin guide for total knee arthroplasty and, more specifically, to patient-customized pin guide for total knee arthroplasty including an anatomical theory-based lower extremity alignment check unit, which enables a doctor to easily and conveniently confirm whether the pin guide is correctly mounted at a planned position of the femur or tibia during artificial knee joint surgery. According to one embodiment of the present invention, the patient-customized pin guide comprises: a pin insertion unit into which a fixing pin for fixing to the femur is inserted; a first confirmation unit forming a line parallel to any one of the transepicondylar axis, posterior condylar axis, and surgical transepicondylar axis of the femur acquired through a 3D image of a patient's femur; and a second confirmation unit forming a line parallel to the anterior and posterior axis (Whiteside's line)of the femur.

Description

Patient-specific pin guide for total knee arthroplasty including an anatomical theory-based lower extremity alignment check part}

The present invention relates to a patient-customized pin guide for an artificial knee joint procedure, and more particularly, an alignment confirmation means that can easily and conveniently check whether the pin guide is seated accurately at a planned position of the femur or tibia during the artificial knee joint operation It relates to a patient-customized pin guide for total knee arthroplasty including an anatomical theory-based lower extremity alignment confirmation unit.

Artificial knee joint surgery is a procedure that started in earnest in the early 1970s. If the knee joint is no longer able to lead a normal life due to various diseases or trauma, and if the disorder is severe, it may not respond to drug therapy or physical therapy. It is a surgery that relieves pain by inserting an artificial joint made of a special alloy and polymer material to patients who cannot be solved by surgical methods, and enables movement of the knee joint while gaining stability and correcting deformation to enable daily life.

This artificial knee joint surgery is being actively performed for patients who have difficulty in daily life due to worn out knee joint. By removing the damaged part of the patella, which is a bone, and inserting and fixing an artificial joint, the knee joint can move normally and walk, so that you can lead daily life without pain.

At this time, the artificial knee joint has several surfaces formed inside so that it can come into contact with the lower end of the femur and the upper end of the tibia, which is designed to support the weight anatomically and mechanically. Therefore, in order to operate the artificial knee joint, it is most important to accurately cut the lower end of the femur and the upper end of the tibia to support the body weight. This is because if the position and direction are set incorrectly, problems with walking may occur.

In general, the mechanical axis of the femur forms an angle of 5 to 10 degrees with the anatomical axis. In the case of the tibia, it should be cut in the direction of the patient's own anatomical slope (Slope) by rotating it about the mechanical axis. In order to accurately cut the artificial knee joint in the direction of the mechanical axis and anatomical inclination angle so that the artificial knee joint, the femur and the tibia can be accurately combined, a separate guide and cutting mechanism must be seated on the femur and tibia to perform the cutting operation.

As an example, Korean Patent Registration No. 10-1738109 (May 15, 2017) discloses a pin guide structure customized for an artificial knee joint patient that can be seated on the femur to stably fix the pin at the correct position of the femur.

In order to form a cut surface for fixing the artificial knee joint in the treatment target area of the femur and tibia, a pin guide having a shape similar to that shown in the above patent document is seated on the treatment target area of the femur and tibia, and then a pin guide is provided The pin is inserted into the pin hole and fixed. After the pin is fixed, the pin guide is separated from the pin, and the cutting guide is mounted on the pin fixed to the bone, and the slot formed in the cutting guide. A cutting surface is formed by inserting a cutting tool into the (slot) part to perform bone cutting.

In this case, since the structure and shape of the bone on which the pin guide is seated is formed differently for each patient, if a standardized pin guide is used, it is necessary to set the exact position of the cut surface at the treatment target area of the femur or tibia. it is impossible For this reason, in the prior art, an image of the femur or tibia of the patient to be treated is acquired and the obtained image is converted into a 3D image to form a 3D image of the pin guide that matches the 3D image of the femur or tibia, and the 3D image of the pin guide By manufacturing and operating a pin guide customized for the patient, it was possible to form an accurate cut surface suitable for the shape of the patient's femur and tibia.

However, as described above, the pin guide manufactured through the 3D image of the patient's femur or tibia is seated on the target site of the femur or tibia, and then a pin is inserted to bind the pin to the femur or tibia. If it cannot be seated in the correct position on the target site, the pin cannot be fixed in the correct position because the pin guide may move during the process of inserting the pin into the pin guide.

That is, it is difficult for the pin guide to be fixed at the correct position of the femur and tibia due to interference by the fascia or soft tissue in the bone area or the slippage of the bone surface during the process of seating the pin guide on the femur and tibia surfaces. If the pin guide is set out of a set position and the pin is fixed in a misaligned or misaligned state, the cutting guide is misaligned at the planned position, resulting in a problem that accurate cutting of the treatment target area of the femur or tibia cannot be performed. .

In addition, in the case of artificial knee joint surgery, the pin guide is seated on the treatment target area of the femur and tibia in a state where the patella is abducted in the outward direction after incision of the skin of the knee joint area, and in this process, the pin guide is abducted Since the pin guide had to be seated on the patellar tendon path of the patellar tendon in a raised state, interference with the patellar tendon occurred, making it difficult to stably mount the pin guide on the bone surface.

Korean Patent Registration No. 10-1738109 (2017.05.15) Korean Patent Registration No. 10-2143842 (2020.08.06)

The present invention has been devised to solve the above problems, and the technical problem to be solved in the present invention is that the pin guide is positioned at the planned position of the femur or tibia through the alignment checking means provided on one side of the pin guide during artificial knee joint surgery. The purpose of this is to provide a patient-specific pin guide for total knee arthroplasty, including an anatomical theory-based lower extremity alignment check unit that can easily and quickly check whether or not it has been correctly settled in the knee joint.

Another technical problem to be solved in the present invention is to check the lower extremity alignment based on anatomical theory that enables the pin guide to be stably fixed in the correct position even on a smooth bone surface by making it easy to secure a contact surface for the fixation target surface of the tibia. The purpose of this is to provide a patient-specific pin guide structure for total knee arthroplasty including buoyancy.

Another technical problem to be solved by the present invention is an anatomical theory-based method that can promote smooth operation with stable fixation of the pin guide by preventing the intervention of the pin guide and the patellar tendon and surrounding tissues during artificial knee joint surgery. The purpose of this is to provide a patient-customized pin guide structure for total knee arthroplasty including a lower extremity alignment check unit.

A patient-customized pin guide for total knee arthroplasty surgery including an anatomical theory-based lower extremity alignment check unit for solving the above technical problem includes: a pin insertion unit into which a fixing pin for fixing to the femur is inserted; Forming a line parallel to any one of the transepicondylar axis, posterior condylar axis, and surgical transepicondylar axis of the femur obtained through the 3D image of the patient's femur a first confirmation unit; It characterized in that it comprises a; a second confirmation portion forming a line parallel to the front and rear axis of the femur (Whiteside's line).

In this case, the first confirmation part and the second confirmation part may be formed in a recessed or raised shape on the outer surface of the pin guide.

Preferably, the pin guide may be fixed to the femur through the fixing pins at positions in which the first and second confirmation units coincide with the surgical epigastric axis and the anteroposterior axis of the femur, respectively.

On the other hand, the patient-customized pin guide for total knee arthroplasty surgery including the anatomical theory-based lower extremity alignment confirmation unit according to another embodiment of the present invention is in contact with the upper end surface of the tibia obtained through the patient's tibia 3D image. a top contact; A pin insertion portion into which a fixing pin is inserted for fixing to the tibia is formed, and a side contact portion in contact with the side surface of the tibia is included, wherein the central axis of the pin insertion portion is viewed from the coronal or axial plane of the tibia. It is characterized in that it is disposed on a position biased by a predetermined angle in the inner direction of the tibia from the front-rear center line of the tibia with respect to the rotation axis of the tibia.

Here, the outer surface of the side contact part may be formed with an alignment check coupling hole to which an alignment check device for checking the alignment state of the pin guide can be detachably coupled.

At this time, it is preferable that the front-rear center line of the alignment check coupler is arranged parallel to the front-rear center line of the tibia.

And, the alignment check device, the coupling member detachably coupled to the coupling hole for checking the alignment; It may be configured to include; an alignment check rod that is coupled to the coupling member to check the alignment state of the pin guide.

In this case, it can be determined that the pin guide is properly fixed when the alignment check rod is disposed on a position passing the medial end point of the tibial tuberosity and the center of the ankle joint or the second toe.

In addition, the pin guide may further include a side support portion extending from the side contact portion toward the inner side of the tibia and supported in contact with the inner intertibial surface of the tibia.

In this case, the side support portion may be supported in contact with the surface of the osteophyte located on the upper side of the inner tibia of the tibia.

According to the patient-customized pin guide structure for total knee arthroplasty surgery including the lower extremity alignment confirmation unit based on the anatomical theory of the present invention, the intercondylar axis of the femur ( Transepicondylar axis), the posterior condylar axis, the surgical transepicondylar axis (Surgical Transepicondylar axis) and the first confirmation portion forming a line parallel to any one of the axis, the anterior-posterior axis of the femur (Whiteside's line) By forming a second confirmation part that forms a line parallel to It is easy and quick to check whether the pin guide is correctly aligned and anchored in the planned position of the femur. Accordingly, it is possible to secure the precise fixing position of the pin that enables bone cutting for each patient, which has the advantage of enabling faster and more accurate treatment.

In addition, in a pin guide structure for tibia comprising an upper contact portion in contact with the upper end surface of the tibia obtained through a 3D image of the patient's tibia, and a side contact portion in which a pin insertion portion into which a fixing pin is inserted is formed and is in contact with the side surface of the tibia , By forming the central axis of the pin insertion part to be disposed on a position that is biased at a certain angle in the inner direction of the tibia from the front-rear center line of the tibia when viewed from the coronal or axial plane of the tibia, the pin insertion process in the fixing process of the pin guide Compared to the existing pin guide structure, the same level of cut surface can be secured, and the pin guide can be fixed more stably on the bone surface because it does not interfere with the patellar tendon and surrounding tissue in an abducted state. have.

In particular, even when the procedure is performed with Minimal-Invasive Surgery, in which the skin is operated through a minimal incision compared to general procedures, the pin guide is stably seated in the tibia and osteophytes on the inner side of the tibia, and the outer part is the incision. Since the pin guide is placed so that it is not disturbed by the pressure of the patella tendon and the patellar tendon, it is possible to position the pin guide as planned without further incision of the skin. It has the advantage of enabling a smooth operation and allowing the patient to recover quickly.

In addition, by mounting an alignment check device on the outer surface of the side contact portion of the pin guide to form an alignment check coupling hole that can check the alignment state of the pin guide and the pin, in a state where the alignment check device is mounted on the alignment check coupling hole It has the advantage of intuitively and quickly and easily checking the alignment of the pin guide and pins by only checking whether the alignment check rod is at the position passing the medial end point of the tibial tuberosity and the center of the ankle joint or the second toe. .

In addition, since the side support part of the pin guide is formed in a structure that is supported in contact with the surface of the osteophyte of the tibia and the medial intertibial surface of the tibia located below it, the medial tibia with a relatively good recovery rate when reconstructed as a three-dimensional image By using the liver and osteophyte as the fixation surface, the pin guide can be stably fixed even on the slippery surface of the bone.

In addition, since there are relatively few peripheral tissues or defects that are not well recognized by CT scan, the side support part can stably contact the inner surface of the lower part of the osteophyte of the tibia, which can be restored similarly to the shape of the actual tibia, thereby exerting support. When the side support part contacts other parts of the tibia, it can be fixed more stably while having superior anchoring force. In addition, in a state in which the pin guide is fixed to the tibia, rotation of the pin guide in the inward and outward directions (horizontal direction) is prevented by the lateral support structure that maintains additional contact with the surface of the tibia under the medial ossicle of the tibia. can do.

1 is a 3D image showing the knee joint area where the femur and tibia of the human body meet.
2 is a photograph showing a state in which the pin guide is seated on the femur and tibia, respectively, in a state in which the patella is abducted during an artificial knee joint operation.
Figure 3 is an image of the femur and the tibia, respectively, viewed from the anterior side of the coronal plane.
Figure 4 is an image viewed from the distal portion of the femur toward the upper side of the axial plane.
5 is a perspective view showing a patient-customized pin guide structure for total knee arthroplasty to be seated on the femur according to the present invention;
Figure 6 is a front perspective view of the pin guide of Figure 5 viewed from the front side.
7 is an image showing a state in which the pin guide of the present invention is seated on the femur.
8 is an image illustrating a state in which the pin guide is incorrectly seated on the femur.
9 to 11 are perspective views showing a patient-specific pin guide structure for total knee arthroplasty to be seated on the tibia according to the present invention.
12 is a cross-sectional image of the pin guide seated on the tibia as viewed from the front side of the coronal plane.
13 is an image of the pin guide seated on the tibia as viewed from the upper side of the axial plane.
14 is a view showing a state in which the pin guide is inserted into the skin incised at the knee joint and mounted on the tibia;
FIG. 15 is a view showing a state in which FIG. 14 is viewed from the side;
16 is a view showing a portion of the contact surface of the tibia in contact with the inner surface of the pin guide.
17 is a view showing a state in which the cutting guide and the alignment check device are mounted after the fixing pin is fixed to the tibia through the existing pin guide.
18 is a view showing a state in which the cutting guide and the alignment check device are mounted after the fixing pin is fixed through the pin guide of the present invention.
19 and 20 are views illustrating a state of confirming the alignment state of the pin guide by combining the alignment check device after fixing the pin guide of the present invention to the tibia.

Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those of ordinary skill in the art can easily carry out the present invention.

However, the present invention may be implemented in several different forms and is not limited to the embodiments described herein. In addition, it should be noted that parts denoted by the same reference numerals throughout the detailed description mean the same components.

Hereinafter, a patient-customized pin guide structure for total knee arthroplasty including an anatomical theory-based lower extremity alignment confirmation unit according to a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

First, FIG. 1 is a 3D image showing a knee joint region where the femur and tibia meet. The femur 10 constituting the upper part of the knee forming the knee joint, the tibia 20 constituting the lower part of the knee, and the knee It is composed of the kneecap 30 which is a bone covering the stomach, and the patellar tendon (patella tendon; 40) has a shape attached to the upper tubercle of the tibia 20 from the lower side of the patella 30.

And, Figure 2 shows a patient-specific pin guide (PSI; Patient Specific Instrument) in a state in which the patella 30 is abducted by incision of the skin of the knee joint region during the artificial knee joint procedure, the lower end of the femur 10 and the tibia (20) is a photograph illustrating a state attached to the upper part of each, (a) is a state in which the pin guide 100 for the femur is fixed to the lower part of the femur 10, (b) is a pin guide for the tibia After the 200 is fixed to the upper end of the tibia 20, the alignment check device 400 is coupled through the coupling member 410 to confirm the alignment of the pin guide with the alignment check rod 420. are giving

As shown in the photo of FIG. 2 , in the case of knee joint surgery, the patella 30 is abducted outwardly after the skin of the knee joint area is incised. In this case, the patella 30 is the femur 10 and the tibia 20 . It has the appearance of being placed on the outside of the In this state, the pin guides 100 and 200 are seated on the lower end of the femur 10 and the upper end of the tibia 20, respectively, and then the pin is inserted into the pin hole formed in the pin guide 100 and 200 to the femur 10 and the tibia ( 20) is fixed to each part. In this case, since the treatment target sites of the femur 10 and the tibia 20 have different shapes, a structure of the pin guides 100 and 200 suitable for the shape of the treatment site may be applied.

However, when the pin guides 100 and 200 are respectively seated on the femur 10 and the tibia 20 to fix the pin, in the conventional pin guide (PSI) structure, a pin guide (PSI) is applied to the bone surface. When seated, it is difficult to stably fix the pin guide due to the rather slippery bone surface, and it is very difficult to check whether the pin guide (PSI) is correctly seated in the planned position even when it is seated. In addition, when the pin guide (PSI) is seated, the pin guide part is in contact with the path on which the patellar tendon 40 is located and interference is made, so that the pin guide is not stably settled on the bone surface of the seated position, so the pin is positioned at the planned position There is a problem in that the reliability of the procedure is lowered by not being accurately fixed to the

In order to improve the problems of the existing technology, in the present invention, the pin guide (PSI) portion that is seated on the femur 10 and the tibia 20 during the artificial knee joint operation is based on the anatomical index of each patient. (PSI) is provided with an alignment confirmation means to intuitively and easily check whether or not it is seated in the correct position on the bone surface, so that it is quickly and easily determined whether the pin guide is accurately seated on the bone surface to be treated through the alignment confirmation means and to provide a patient-customized pin guide structure capable of performing faster and more accurate procedures through this. In addition, the present invention provides that the pin guide (PSI) is stably positioned at the exact target position on the bone surface without interference between the pin guide (PSI) and the patellar tendon (40) in an abducted state during the artificial knee joint operation. It provides a structure of the guide pin to be seated.

First, the structure of the pin guide 100 of the present invention seated on the femur 10 will be described in detail. In a general knee joint procedure, the femur 10 is distal when viewed from a coronal plane. , When viewed from the sagittal plane, bone cutting is performed according to the anterior and posterior, and rotational alignment, and when determining the rotational alignment, it is determined based on anatomical indicators.

3 shows the femur 10 and the tibia 20 when viewed from the front side of the coronal plane, respectively, and FIG. 4 is a view from the distal part of the femur 10 in the axial plane (Transverse plane) direction. it has been shown

In general, the mechanical axis of the femur 10 (Femur mechanical axis) is inclined at a certain angle with the anatomical axis, and in the coronal plane direction of the femur 10, the distal portion of the femur 10 is cut at a right angle to the mechanical axis, and external rotation is determined in the direction of the transverse plane of the femur 10 to be cut. In this case, the amount of external rotation in the femur 10 is a very important factor because it is related to the trajectory of the patella, internal and external balance during flexion, and the axis of extension and flexion.

As a conventional method for determining external rotation in the femur 10, as shown in FIG. 4, a method largely determined by a Transepicondylar axis, a method determined by a Posterior condylar axis, an anterior-posterior axis (Whiteside's line) It can be divided into a method of determining by , and a method of determining by a surgical phase and a liver axis (Surgical Transepicondylar axis).

In the structure of the customized pin guide (PSI) for the femur according to the present invention, it can be intuitively and easily checked whether the pin guide is accurately seated on the treatment target site of the femur 10 based on the anatomical index of the femur 10 listed above. By doing so, it is provided with an alignment confirmation means that can help to accurately set the fixing position of the fixing pin so that bone cutting suitable for each patient is possible.

5 and 6 show a patient-customized pin guide structure for artificial knee joint surgery according to the present invention applied to the femur.

5 and 6, the patient-customized pin guide 100 for seating the femur according to the present invention is seated on the distal side of the femur 10 and is in contact with the distal lower surface of the femur 10. a contact 110 and a front contact 120 in contact with the anterior portion of the distal portion.

The lower surface contact portion 110 is located on the distal lower surface side of the femur 10 and comes into contact with a portion of the lower surface of the distal portion, and the front contact portion 120 is bent and extended from one side of the lower surface contact portion 110 to meet a portion of the front surface of the distal portion. touch and touch In addition, pin insertion parts 112 and 122 are formed on the outer surfaces of the lower surface contact part 110 and the front contact part 120 so that the fixing pins 60 can be inserted, respectively.

At this time, on the outer surface of the lower contact part 110, the pin guide 100 is seated on the treatment target site of the femur 10 based on the anatomical index of the femur 10 possessed by each patient and is accurately aligned at the planned position. Alignment confirmation means is provided to confirm whether or not.

Specifically, the alignment confirmation means formed on the lower surface contact part 110 is, as seen in the shape of the femur 10 shown in FIG. 4, the femur 10 obtained through the 3D image of the individual patient's femur 10. Transepicondylar axis (TEA), Posterior condylar axis (PCA), Surgical Transepicondylar axis (STEA) forms a line parallel to any one of the specific axis, the specific one axis The first confirmation unit 114 that can check whether the alignment and the alignment state match, forms a line parallel to the anterior-posterior axis (Whiteside's line; WL) of the femur 10, and the alignment state with the anterior-posterior axis (WL) is and a second check unit 124 that can check whether they match.

In this case, the first confirmation part 114 and the second confirmation part 124 may be formed in the form of a straight line recessed or raised on the outer surface of the lower surface contact part 110 . In this embodiment, the structure in which the first confirmation part 114 and the second confirmation part 124 are engraved (recessed) in the form of a straight line is shown as an example thereof.

And, the anatomy of the intercondylar axis (TEA), the posterocondylar axis (PCA), and the surgical epicondylar axis (sTEA) of the femur 10 to compare the alignment state with the first confirmation unit 114 The anatomical indicators are selectable by the operator (doctor), and any one of the several anatomical indicators may be selected according to the operator's propensity to operate. In the structure of the pin guide 100 according to the embodiment of the present invention, when the first confirmation part 114 is parallel to the surgical sTEA and sTEA, the structure formed in the form of an engraving on the outer surface of the contact part 110 is It is shown as an example.

In this way, the first confirmation part 114 that is parallel to the surgical epigastric axis (sTEA) on the outer surface of the lower surface contact part 110 of the pin guide 100, and the second confirmation that is parallel to the anterior-posterior axis (WL) By having an alignment confirmation means composed of the part 124, the contact part 110 is formed on the outer surface of the lower surface in a state where the pin guide 100 is seated on the distal part of the femur 10 to be treated during the artificial knee joint operation. Check whether the first confirmation part 114 and the second confirmation part 124 coincide with the surgical epigastric axis (sTEA) and the anterior-posterior axis (WL) of the femur 10, respectively, so that the pin guide 100 is properly It can be checked intuitively and easily whether it has been settled or not.

7 is an illustration of a state when the pin guide 100 of the present invention is properly seated on the femur 10, as shown in FIG. 7, the pin guide 100 is properly seated on the femur 10 portion In this state, the first confirmation unit 114 coincides with the surgical phase and liver axis (sTEA) of the femur 10, and the second confirmation unit 124 coincides with the anterior-posterior axis (WL), respectively.

In this way, the first confirmation part 114 and the second confirmation part 124 formed on the lower surface contact part 110 coincide with the surgical epigastric axis (sTEA) and the anterior-posterior axis (WL), respectively, and the pin guide 100 After it is confirmed that the is properly seated, the fixing pin 60 is inserted into each of the pin insertion portions 112 and 122 at the seated position to perform the fixing operation of the fixing pin 60 to the femur 10 .

For reference, FIG. 8 shows a state when the pin guide 100 of the present invention is not properly seated on the femur 10 portion. As shown in FIG. 8, when the pin guide 100 is not properly seated in the planned position of the femur 10, the first confirmation unit 114 and the second confirmation unit 124 are surgically installed on the axis ( sTEA) and the anterior-posterior axis (WL) do not coincide with each other and are in a distorted state. Therefore, the operator adjusts the position of the pin guide 100 to a position where the first confirmation unit 114 and the second confirmation unit 124 coincide with the surgical epigastric axis (sTEA) and the anterior-posterior axis (WL), respectively can be easily performed.

As described above, the pin guide 100 for a femur according to the present invention provides an anatomical structure of the femur 10 obtained through a 3D image of the individual femur 10 even in a situation in which stable fixation of the pin guide is difficult due to a smooth bone surface. By using the indicators, the alignment state of the pin guide 100 can be easily checked and Because it can be modified, there is an advantage that a faster and more accurate treatment than the conventional general pin guide is possible.

On the other hand, the structure of the patient-customized pin guide 200 according to the present invention applied to the tibia 20 is shown in FIGS. 9 to 11 .

9 to 11, the structure of the patient-customized pin guide 200 for tibia according to the present invention, the upper contact portion 210 in contact with the upper end surface of the tibia 20 obtained through the 3D image of the patient's tibia 20 ), and a pin insertion portion 223 into which the fixing pin 60 for fixing to the tibia 20 is inserted is formed and configured to include a side contact portion 220 that is in contact with the side surface of the tibia 20 .

The upper contact portion 210 is a portion in contact with the seating surface of the Tibial Plateau of the tibia 20, and the first contact portion 212 in contact with the inner upper end surface of the tibia 20, and the outer side of the tibia 20 Consists of a second contact portion 214 in contact with the upper end surface, and the first contact portion 212 and the second contact portion 214 have a plurality of contact surfaces capable of compensating for lost cartilage at the upper end of the tibia 20 It has a structure in which the protrusion 216 is formed. Here, in the embodiment of the present invention, a structure in which the protrusion 216 is formed on the contact surface 215 of the second contact portion 214 is shown as an example.

The plurality of protrusions 216 formed on the contact surface 115 of the second contact portion 214 have a cylindrical shape and are formed to protrude downward. In this case, it can be formed by varying the number, arrangement state, protrusion width, etc. of the protrusions 216 according to the state of the site in which the cartilage is lost. Preferably, the protrusion width of the protrusions 216 is in the range of 0.5mm to 1mm. It can be formed to have a protruding width inside.

And, the contact surface 213 of the first contact portion 212 in which the protrusion 216 is not formed is formed to have a shape spaced apart from the upper end surface of the tibia 20 by the thickness of the cartilage remaining in the inner upper end of the tibia 20. can

In this way, as a plurality of cylindrical protrusions 216 having a protrusion width of about 0.5 to 1 mm are formed on the outer side of the tibia 20, the cartilage portion lost through the plurality of protrusions 216 can be compensated. In consideration of the thickness of the cartilage remaining without loss of about 0.5 to 1 mm on the medial side, the contact surface 213 of the first contact part 212 in contact with the inner part of the tibia 20 is compensated by giving a gap as much as the thickness of the cartilage. can

In addition, when seated on the tibia 20, the spacer 221 is spaced apart from the surface of the tibia 20 by a predetermined distance on the inside of the side contact part 220 to form a spaced space 222 in a stepped shape therein. is formed

The spacer 221 is a certain distance (E) toward the outer direction of the side surface of the tibia 20 based on the contact surface 225 of the side contact portion 220 in contact with the upper side surface of the tibia 20 It is provided so that the inner space 222 of the stepped shape is formed in a portion of the contact surface 225 of the side contact part 220 by being positioned at a spaced apart position.

In this case, in consideration of the thickness of the patellar tendon 40 including the soft tissue of the portion including the inner portion from the inner portion of the tuberous surface of the tibia 20, the contact surface 225 of the side contact portion 220, the spaced portion 221 is It may be formed at a position spaced inward by 5 mm based on the .

In this case, the data related to the separation dimension of the spacer 221 may be generated based on the surface data of the 3D model of the tibia 20 when the pin guide 200 is manufactured, for example, the surface of the tibia 20 . The distance between the spaced part 221 of the pin guide 200 and the pin guide 200 can be set to be spaced apart by about 7 to 10 mm, and the spaced part 221 except for the pin insertion part 223 provided on the outside in the side contact part 220 . The thickness of the part may be set to about 14 to 16 mm.

In this way, the inner portion of the pin guide 200 by the spaced portion 221 provided on the inside of the contact surface 225 of the side contact portion 220 is spaced apart in a stepped form having a sufficient size for the patellar tendon 40 to pass. Since the space 222 can be formed, when the pin guide 200 is seated on the upper part of the tibia 20 during artificial knee joint surgery, the patellar tendon ( 40) without interfering with the tibia 20 can be stably settled in the upper part.

On the other hand, on the outer surface of the side contact part 220, the pin guide 200 is a pair of pin insertion parts 223 capable of inserting the fixing pins 60 in a state where the pin guide 200 is completely fixed at the fixing target position of the upper part of the tibia 20 . is formed

In this case, in the structure of the pin guide 200 of the present invention, unlike the conventional pin guide structure, when the artificial knee joint is operated, the patella 30 is abducted in the lateral direction of the tibia 20, considering that the operation is performed. In order to avoid interference with the patellar tendon 40 and surrounding tissues of the state, the pin insert 223 is disposed on a position biased at a certain angle in the inner direction of the tibia 20 .

That is, in the conventional pin guide structure, the pin insertion part is formed to be parallel to the anteroposterior center line C1 of the tibia 20 with respect to the rotation axis of the tibia 20 in a state seated on the tibia 20, but the present invention The structure of the pin guide 200 is viewed from the coronal plane or the axial plane of the tibia 20 to the pin guide 200 seated on the tibia 20 as shown in FIGS. 11 and 13 . When viewed, the central axis C2 of the pin insertion unit 223 is disposed on a position biased by a predetermined angle in the inner direction of the tibia 20 from the front-rear center line C1 of the tibia 20 .

As described above, as the pin insertion part 223 formed on the outer surface of the side contact part 220 of the pin guide 200 is disposed at a certain angle in the inner direction of the tibia 20, the pin guide on the upper part of the tibia 20 When the fixing pin 60 is inserted after the seating of the 200 is completed, the fixing pin 60 is inserted from the inner direction of the tibia 20 toward the center of the tibia 20 and fixed as shown in FIG. 13 . The cut surface of the upper part of the tibia 20 remains the same as when the conventional pin guide is applied, and the pin insertion part 223 does not interfere with the patellar tendon and surrounding tissue in an abducted state, so that the tibia 20 The fixing of the pin guide 200 to the portion can be made more stably.

In addition, in general artificial knee joint surgery, the skin is incised by about 12-15 cm. In the case of Minimal-Invasive Surgery, which has been widely applied recently, the skin is incised to a minimum size of about 7-9 cm. will be treated As such, in the case of performing a knee arthroplasty by applying the minimally invasive surgical method, since the incision of the skin is small, the pin guide structure has a structure in which the central axis of the pin insertion part is parallel to the anteroposterior center line of the tibia. There is a disadvantage in that it is difficult to smoothly seat the guide.

However, in the structure of the pin guide 200 of the present invention, since the pin insertion part 223 is disposed in a shape that is twisted at a certain angle (θ) toward the inner direction of the tibia, the minimum incision of the knee joint skin compared to the general procedure Even when the procedure is performed by invasive surgery (minimal-invasive surgery), the seating of the pin guide 200 can be made more easily.

That is, in the case of a minimally invasive surgical procedure, as shown in FIGS. 14 and 15, the patellar tendon 40 passes into the stepped space 222 of the pin guide 200, so the patellar tendon ( 40) and the surrounding tissue, the pin guide 200 can be stably seated on the treatment target site of the tibia 20 without interference, and the pin insertion unit 223 twisted in the inward direction is in a state of being abducted from the incision. It is possible to position the pin guide 200 as planned even without further incision of the skin because it is spaced apart in the inward direction so as not to interfere with being pushed by the patellar tendon 40 . Accordingly, the present invention has the advantage that it is possible to provide a structure of the pin guide 200 that is very suitable for a minimally invasive surgical method, and a smooth operation using the minimally invasive surgical method is possible, thereby enabling a quick recovery of the patient.

On the other hand, when the artificial knee joint is operated using the pin guide 200 of the present invention, the pin guide 200 is seated in contact with a specific part of the tibia 20 that is easy to secure a contact surface with the pin guide 200 . Making it possible is the most important thing.

In the case of the pin guide structure for tibia according to the existing technology, the biggest problem was the unstable seating of the pin guide on the tibia. It is inaccurate and the contact area between the pin guide and the tibia surface is limited.

In the conventional pin guide for tibia, the pin insert is formed so that the pin can be positioned inside and outside the upper end of the high flat part of the tibia, so that it can be in contact with the upper part of the tibial rough surface. However, the external characteristics of the tibia on which the pin guide is seated are insignificant, and a lot of interference occurs when the pin guide is seated due to the thin fascia or soft tissue that exists in the seated area. There was a lot of difficulty in getting it seated in the correct position.

In addition, in order to avoid interference between the patella tendon and the pin guide due to abduction of the patella during artificial knee joint surgery, the contact area on the outside of the front part of the pin guide is reduced by half or less. However, in this case, the pin guide was not stably settled on the smooth tibia surface, so that the pin guide was shaken or twisted in many cases.

In the structure of the pin guide 200 of the present invention, the external features (for example, surface curvature) are relatively prominent compared to other seating areas, while the reliability according to the stable fixation of the pin guide is high by supplementing the problems of the above-described existing technology. When reconstructing in three dimensions, the tibia 20 region more stably without shaking or twisting the pin guide 200 by securing the medial intertibialis 21 part (see FIG. 16 ) of the tibia 20, which has a relatively good restoration rate, as an additional contact surface. can be settled in

To this end, the pin guide 200 of the present invention is formed to extend from one side of the side contact part 220 toward the inner direction of the tibia 20 (the inner direction of the leg when standing), and the inner tibialis 21 of the tibia 20 ) has an inner surface shape corresponding to the surface and is additionally provided with a side support 230 structure supported in contact with the inner tibialis 21 surface of the tibia 20 . In this case, the side support 230 can be supported in contact with the surface of the raised-shaped osteophyte 22 located on the upper side of the inner tibia 21 of the tibia 20 as shown in FIG. 16 . have. Here, the portions indicated in color on the tibia 20 of FIG. 16 are portions in direct contact with the pin guide 200 .

On the other hand, in general, the alignment of the patient's leg to be subjected to artificial knee joint surgery is divided into a varus or valgus type, and in the vicinity of the outer side of the tibia 20, a thin and long form parallel to the tibia 20 is formed. The fibula (50) is located. For this reason, when the side support 230 is made to be supported by contacting the outer surface of the tibia 20 where the fibula 50 is located through the contact surface 232, the actual pin guide 200 due to the abduction of the patella during surgery. ) may interfere with the patellar tendon (40) region in seating.

For this reason, in the structure of the pin guide 200 of the present invention, the side support part 230 is contacted through the contact surface 232 only on the inner intertibialis surface of the tibia 20 irrespective of the patient's varus or valgus to exert a supporting force. is designed

Here, the medial tibial stem 21 positioned under the osteophyte 22 of the tibia 20 has fewer peripheral tissues or defects that are not well recognized by CT scan when realizing a 3D model of the tibia through a CT scan image. Since it can be restored similarly to the shape of the tibia 20, the restoration rate of the tibia 3D model is also excellent.

Therefore, while making contact with the surface of the inner tibial shaft 21 located below the osteophyte 22 of the tibia 20 on one side of the side contact part 220 of the pin guide 200, additional support force of the pin guide 200 is secured. By forming the side support 230 that can do it, the pin guide 200 can be more stably fixed while having an excellent anchoring force than when in contact with other parts of the tibia 20 .

And, when performing artificial knee joint surgery using the pin guide 200 for tibia of the present invention, the pin guide ( 200) is seated on the exposed tibia 20 to perform the operation, and there is no need to make an additional skin incision in order to seat the side support 230 of the pin guide 200 on the inner intertibial part of the tibia 20. none.

That is, in the pin guide 200 of the present invention, the side support portion 230 is seated as if it is inserted between the tibia 20 bone and the incised skin tissue, so that the inner side portion of the tibia 20 is on the side surface. The support part 230 is designed to make stable contact and secure the support force. For this reason, even when the procedure is performed by a minimally invasive surgery method in which the skin of the knee joint is minimally incised compared to a general procedure, the seating of the pin guide 200 can be made more easily.

In addition, in the state in which the pin guide 200 is seated on the upper part of the tibia 20, the side support part ( 230) structure, it is possible to prevent the pin guide 200 from rotating in the inner and outer directions (horizontal direction).

At the same time, the pin guide 200 of the present invention is formed in a shape in which the side support part 230 is cut in the vertical direction so that the thickness seen from the side direction becomes gradually thinner toward the lower side of the tibia 20 .

When formed in this way, when the pin guide 200 is fixed to the tibia 20 in a state in which the skin around the knee is incised during the artificial knee joint operation, the side support part 230 having a relatively thin thickness. It is easily inserted into the gap between this bone and the tissue of the skin and can be easily seated on the surface of the inner side of the tibia 20 . In this case, the upper thickness width of the side support part 230 may be set within a range of 6 mm to 8 mm, and a lower thickness width to 4 mm to 6 mm.

Similarly, the side support 230 is configured to have a shape in which the thickness of the horizontal cross-section (cross-section) viewed from the top gradually becomes thinner from the outer direction to the inner direction of the tibia 20, so that the side support portion 230 having a thin thickness ) The inner end portion can be easily fitted into the gap between the bone and the skin tissue to be easily seated on the inner surface of the tibia 20 .

On the other hand, in the structure of the pin guide 200 of the present invention, when designing the horizontal width dimension of the side support part 230, the pin guide 200 is to have a contact area with the bone as long as possible in the horizontal direction without undercut. is very important for the stable settlement of

However, when the side support 230 of the pin guide 200 is seated in a form enveloping the bone beyond the point (F, see FIG. 13) at which the curvature changes greatly on the surface of the tibia 20, the pin guide 200 is then When removing, the side support 230 is caught at the inflection point (F) portion of the curvature, so the removal operation of the pin guide 200 may be difficult, and also the pin guide 200 due to the interference of the inflection point (F). A phenomenon in which the fixing position of the fixing pin 60 is misaligned may occur by changing the position of the .

In order to prevent this, the horizontal width of the side support 230 of the pin guide 200 should be designed not to exceed the F point so as not to interfere with the curvature inflection point (F) portion of the inner surface of the tibia 20 . For this reason, in the pin guide 200 of the present invention, the end of the side support part 230 facing in the inner direction of the tibia 20 is formed so as not to exceed the point of curvature inflection point (F) at which the outer surface curvature of the tibia 20 changes to the maximum. has been

On the other hand, when cutting the upper part of the tibia 20 for artificial knee joint surgery, bone cutting is performed at a right angle to the mechanical axis (MA) when viewed from the coronal plane, and at this time, it is confirmed that the correct bone cutting is performed. In order to do this, a separate alignment check device is used to compare it with anatomical indicators, and the alignment check device is usually fixed together to the cutting guide of the tibia.

17 is a view showing a state in which the cutting guide and the alignment confirmation device are mounted after fixing the fixing pin to the tibia through the pin guide of the prior art. As shown in FIG. 17, the fixing pin using the conventional pin guide structure After fixing the 60 to the tibia 20, the pin guide is removed from the fixing pin 60, and then the cutting guide 300 is mounted on the fixing pin 60 fixed to the tibia 20, A cutting tool is inserted into the slot 320 provided in the cutting guide 300 to perform a bone cutting operation.

In this process, by mounting the alignment checking device 400 on the cutting guide 300 to check whether the cutting guide 300 is properly aligned at the planned position, the coupling member 410 of the alignment checking device 400 The alignment state can be checked by checking whether the lower end of the alignment check rod 420 inserted into the cutting guide 300 and connected to the coupling member 410 is located at the ankle joint or the second toe part.

However, since the pin guide 200 of the present invention has a structure in which the pin insertion part 223 is twisted at a certain angle (θ) toward the inner direction of the tibia 20 as shown in FIG. 11, the pin guide 200 of the present invention ), when the fixing pin 60 is fixed to the tibia 20 part, the fixing structure of the fixing pin 60 obliquely entering the center from the inside of the tibia 20 as shown in FIG. 18 . will have Accordingly, the cutting guide 300 mounted on the fixing pin 60 also has a shape that is obliquely twisted in the inner direction of the tibia 20, and the alignment check rod 420 mounted on the cutting guide 300. In addition, since it has a structure biased in the inner direction of the tibia 20 when viewed from the coronal plane of the tibia 20, it is difficult to confirm the alignment check rod 420 with reference to the anatomical index. (20) A problem may occur that makes it difficult to easily check whether the cut is made at right angles to the mechanical axis (MA).

In order to compensate for such a problem, the pin guide 200 structure of the present invention is equipped with an alignment check device 400 on the outer surface of the side contact part 220 so that the pin guide 200 and the fixing pin 60 are designed for the tibia. An alignment confirmation means is provided that can intuitively check whether or not it is correctly mounted in a position.

19 and 20 show the alignment state of the pin guide 200 and the fixing pin 60 by combining the alignment check device 400 after the pin guide 200 of the present invention is seated on the treatment target site of the tibia 20. Checking the is exemplified.

19 and 20 , in the pin guide 200 of the present invention, the alignment check device 400 is mounted on the outer surface of the side contact part 220 so that the pin guide 200 and the fixing pin 60 are planned. A coupler 250 for checking alignment to which the alignment checking device 400 can be mounted is formed to protrude so that it can be checked whether or not it is accurately fixed on the position.

Here, the alignment check device 400 is coupled to the coupling member 410 detachably coupled to the coupling member 250 for checking alignment, and the coupling member 410 to determine whether the anatomical index coincides with the tibia It is configured to include a rod 420 for checking alignment that can check whether the cut surface of the treatment site of (20) is perpendicular to the mechanical axis (MA).

The alignment check coupling sphere 250 forms a rectangular parallelepiped-shaped external structure, and when the coupling member 410 is coupled with the coupling member 410, the coupling member 410 is not interfered with the skin tissue in the incised state. It has a structure formed by protruding by a predetermined width toward the front side of the tibia 20 so as to be easily coupled to the part.

In addition, the interior space 251 of a rectangular parallelepiped shape into which a 'U'-shaped connection part 412 provided on one side of the coupling member 410 can be inserted is formed in the coupling hole 250 for checking alignment, and the It is formed in a closed structure in which a wall 252 is formed inside the inner space 251, and both ends of the connection part 412 are fitted in the blocked inner wall 252 part and a pair of coupling holes that can be coupled ( 253) is formed.

The alignment check coupler 250 having such a structure is formed on the upper side spaced apart from the pin insertion unit 223 by a predetermined distance, and is twisted at a predetermined angle in the outward direction of the tibia 20 from the pin insertion unit 223 . placed in the form

That is, the coupler 250 for checking alignment is arranged so that its front-back center line (C3) is parallel to the front-rear center line (C1) of the tibia (20) and viewed from the top of the axial plane (Transverse plane) of the tibia (20) When the alignment confirmation coupler 250 is disposed to face the front side of the tibia 20, the pin insertion part 223 has a central axis (C2) of the tibia 20 in the front-rear direction center line (C1) Since it is disposed in a state that is twisted at a certain angle (θ) in the inner direction of the tibia 20 with respect to the alignment check coupling member 250 is a configuration of a shape twisted at a certain angle outward with respect to the pin insertion part 223 will have

Therefore, in the state in which the alignment check device 400 is mounted on the alignment check coupling port 250 portion of the pin guide 200, the alignment check rod 420 as shown in FIG. 20 is the tibia 20 as before. It can be formed to be placed to a position where it is easy to identify the alignment state through anatomical indicators of At this time, in the structure of the pin guide 200 of the present invention, as shown in FIG. 20 , the alignment check rod 420 in the state where the alignment check device 400 is mounted on the alignment check coupling port 250 part of the pin guide 200 . When is disposed at a position passing through the medial end point of the tibial tuberosity, which is the portion protruding from the tibia 20 to the upper anterior side, and the center of the ankle joint or the second toe, the pin guide 200 and the fixing pin 60 It can be judged that it is properly settled on this design position. In this way, by mounting the alignment checking device 400 on the part of the alignment check coupling hole 250 of the pin guide 200, the pin guide 200 is placed on an accurate position where bone cutting can be made at a right angle to the mechanical axis MA. ) and the fixing pin 60 have the advantage of being able to quickly and easily and intuitively check whether the operator is properly seated.

In the above, preferred embodiments of the present invention have been described, but the scope of the present invention is not limited to these specific embodiments, and those skilled in the art will appropriately change within the scope described in the claims of the present invention. this will be possible

10: femur 20: tibia
30: patella 40: patella tendon
50: fibula 60: fixing pin
100: (for tibia) pin guide 110: lower surface contact part
114: first confirmation unit 124: second confirmation unit
120: front contact 210: top contact
212: first contact 214: second contact
216: protrusion 220: side contact
221: spaced part 112, 122, 223: pin insertion part
230: side support 250: coupling for alignment check
251: interior space 252: wall
253: coupling hole 300: cutting guide
400: alignment check device 410: coupling member
412: connection part 420: rod for checking alignment

Claims (10)

In the patient-customized pin guide for total knee arthroplasty that is seated on the patient's femur,
a pin insertion unit into which a fixing pin for fixing to the femur is inserted;
Forming a line parallel to any one of the transepicondylar axis, posterior condylar axis, and surgical transepicondylar axis of the femur obtained through the 3D image of the patient's femur first confirmation unit;
Including; a second confirmation unit forming a line parallel to the anterior and posterior axis of the femur (Whiteside's line);
The first confirmation part and the second confirmation part for total knee arthroplasty including an anatomical theory-based lower extremity alignment confirmation part, characterized in that it is formed in the form of a receding or raised straight line on the outer surface of the pin guide. Patient-specific pin guides.
delete According to claim 1, wherein the pin guide is fixed to the femur through the fixing pins at positions that coincide with the surgical phase and liver axis and the anterior-posterior axis of the first and second confirmation parts of the femur, respectively. Patient-specific pin guide for total knee arthroplasty including lower extremity alignment confirmation unit based on anatomical theory.
an upper contact portion in contact with the upper end surface of the tibia obtained through a 3D image of the patient's tibia;
Including a; a pin insertion portion is formed in which a fixing pin for fixing to the tibia is inserted, and a side contact portion in contact with the surface of the side portion of the tibia;
The central axis of the pin insertion part is disposed on a position that is biased by a predetermined angle in the inner direction of the tibia from the front-rear center line of the tibia with respect to the rotation axis of the tibia when viewed from the coronal or axial plane of the tibia;
On the outer surface of the side contact part, an alignment check coupling hole that can be detachably coupled to an alignment check device for checking the alignment state of the pin guide is formed,
The alignment check device,
a coupling member detachably coupled to the coupling hole for checking alignment; and
A patient-customized pin guide for total knee arthroplasty including an anatomical theory-based lower extremity alignment confirmation unit, characterized in that it includes; a rod for checking alignment that is coupled with the coupling member to check the alignment of the pin guide.
delete According to claim 4, wherein the anteroposterior center line of the alignment check coupler is arranged in parallel with the anteroposterior center line of the tibia. pin guide.
delete [Claim 5] The method of claim 4, wherein when the alignment check rod is disposed on a position passing the medial end point of the tibial tuberosity and the center of the ankle joint or the second toe, it is determined that the pin guide is properly fixed. A patient-customized pin guide for total knee arthroplasty including a lower extremity alignment confirmation unit based on anatomical theory of
[Claim 5] The lower extremity alignment check based on anatomical theory according to claim 4, further comprising a side support part extending from the side contact part toward the medial direction of the tibia and supported in contact with the medial intertibialis surface of the tibia. Patient-specific pin guides for total knee arthroplasty including bu.
10. The total knee arthroplasty procedure according to claim 9, wherein the lateral support part is supported in contact with the surface of the osteophyte located above the medial tibia of the tibia and is supported by an anatomical theory-based lower extremity alignment confirmation part. For patient-specific pin guides.

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