KR101488396B1 - A medical guide device for rotational alignment of femoral components - Google Patents

Abstract

The present invention relates to a new reference axis for rotational alignment of the femoral component during a total knee arthroplasty and a medical guide device for identifying the same in a surgical field. Using the guide device of the present invention, it is possible to easily identify the inter-ligament axis within the surgical field, and accurate alignment of the femoral component can be performed based on the axis, thereby increasing the probability of success of the total knee arthroplasty.

Description

Technical Field [0001] The present invention relates to a medical guide device for rotational alignment of a femoral component,

The present invention relates to a new reference axis for rotational alignment of the femoral component during a total knee arthroplasty and a medical guide device for identifying the same in a surgical field.

To achieve successful results of total knee arthroplasty, it is most important to have an accurate alignment. In a real clinical study, better alignment was found to be associated with better functional outcome than outliers (Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. J Arthroplasty 2009; 24: 570 -578). In the navigation system, the coronal plane is known to have high accuracy, but the femoral component does not show any better results (Hetaimish BM, Khan MM, Simunovic N, Al- Harbi HH, Bhandari M, Zalzal PK J Arthroplasty, 2012; 27: 1177-1182).

In rotational malalignment of the femoral component, patellar maltracking, anterior knee pain, femoro-tibial flexion instability, and premature wear of the polyethylene insert may occur (Barrack RL, Schrader T, Bertot . AJ, Wolfe MW, Myers L. Clin Orthop Relat Res 2001: 46-55; Berger RA, Crossett LS, Jacobs JJ, Rubash HE Clin Orthop Relat Res 1998:.. 144-153; Hofmann S, Romero J, Roth- Schiffl E, Albrecht T. Orthopade 2003; 32:. 469-476; Insall JN, Scuderi GR, Komistek RD, Math K, Dennis DA, Anderson DT Clin Orthop Relat Res 2002:.. 143-152; Wasielewski RC, Galante JO Clinical Orthop Relat Res . 1994: 31-43), which results in impaired function and a high wage rate (Hofmann S, Romero J, Roth-Schiffl E, Albrecht T. Orthopade 2003. Leighty RM, Natarajan RN, Rosenberg AG. ; 32: 469-476; Incavo SJ, Wild JJ, Coughlin KM, Beynnon BD, Clin Orthop Relat Res 2007; 458: 131-136; Romero J, Stahelin T, Binkert C, Pfirrma nn C, Hodler J, Kessler O. J Arthroplasty 2007; 22: 235-240).

Post-operative coronary alignment requires a CT scan to measure axial rotational alignment (Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS, Clin Orthop Relat Res 1993: 40-47). For this reason, the importance of rotational alignment has long been overlooked. Recently, a surgical transepicondylar axis (TEA), which connects the prominence of the sulcus with the lateral aspect, has been applied to the functional flexion-extension axis of the posterior femoral condyle found to be so (functional flexion-extension axis) ( Asano T, Akagi M, Nakamura T. J arthroplasty 2005; 20:. 1060-1067), most surgeons to total knee arthroplasty when the femoral component parallel to the operative position TEA . However, it is difficult to reproduce surgical TEA within the operative field.

If there is a new reference axis that can improve surgical reproducibility and accuracy during surgery, this can lead to excellent surgical results.

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.

Under these circumstances, the present inventors have made efforts to develop a reliable reference axis that can be easily identified in the surgical field and a mechanism for identifying the same, for precise rotational alignment of the femoral component during knee arthroplasty. The present inventors confirmed that the translational fundamental axis, which is the line connecting the lower edge of the superficial medial collateral ligament and the lower edge of the sagittal base, is a reliable axis for rotational alignment of the femoral implant, Thereby completing the present invention.

Accordingly, it is an object of the present invention to provide a medical guide device for rotational alignment of a femoral component during a total knee arthroplasty.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.

According to one aspect of the present invention, there is provided a surgical instrument comprising: a linear body having a sliding member in a longitudinal direction on one surface thereof; and a superficial medial collateral ligament provided on one end of the linear body to form a popliteus tendon origin or a superficial medial collateral ligament, A first guide member having a first stretching member which is engaged with a lower edge of the first guide member; And a second stretching member which is provided at the other end of the linear plate and is engaged with the lower edge of the superficial inner side ligament or sow gun base portion, the straight plate having one end inserted into the other end of the straight body and sliding in the longitudinal direction on the sliding member, The first guide member and the second guide member are coupled to each other at a different position. The guiding device for a medical guide for rotational alignment of the femoral component during a total knee arthroplasty is provided.

The present inventors have made efforts to develop a reliable reference shaft that can be easily identified in the surgical field and a mechanism for identifying the same, for precise rotational alignment of the femoral component during knee arthroplasty. The present inventors confirmed that the translational fundamental axis, which is the line connecting the lower edge of the superficial medial collateral ligament and the lower edge of the sagittal base, is a reliable axis for rotational alignment of the femoral implant, A medical guide device which can be confirmed was manufactured.

According to an embodiment of the present invention, the linear plate of the second guide member may be marked with a scale along the longitudinal direction.

According to an embodiment of the present invention, the linear plate of the second guide member may be provided with a fixing member for fixing the linear plate on the sliding member.

According to an embodiment of the present invention, the straight body may further include a whitesite reference line reference bar on one side.

According to an embodiment of the present invention, the first and second stapling members may be attached to the lower edge of the sagittal base portion or the superficial medial collateral ligament exposed at the 85-95 degree bent knee. In one particular example, the angle of the knee is substantially perpendicular.

Meanwhile, the interlabial axis, which is a reliable reference axis for rotational alignment of the femoral component, was first identified by the present inventors through the following procedure.

A total of 14 knee joints were obtained from Korean cadavers (7 ku) and drug treated cadavers (7 ku). The average age was 55 years (range 25-73 years). In each carcass, one half was peeled to the right and the other half to the left. Deep medial collateral ligament (Deep MCL) was isolated and superficial MCL was retained. For all knees, an intramedullary guide for artificial knee joints was inserted into the valgus at 6 degrees and distal cutting was performed along the cutting jig. The prominence was confirmed by exposing the medial epicondyle and lateral epicondyle, and the metal pin was inserted parallel to the joint surface. Using a digital caliper with the knee flexed 90 degrees, the shortest distance between the inner margin and the lower margin of the superficial MCL inserted in the medial and apical points was measured, The shortest distance between the metal pin inserted in the upper and the tip and the lower edge of the base of the sled gun was measured. Next, the distance between the tip of the metal pin inserted in the medial and lateral phases was measured using a digital caliper (transepicondyle distance).

And the distance between the upper and lower edges of the superficial MCL is taken as the height of the outer edge and the lower edge of the base of the tendon, The angle was obtained. The angle obtained here corresponds to the angle between the anatomical image and the anatomical TEA and the translational axis (the lower edge of the superficial MCL - the lower edge of the sagittal origin).

Statistical analysis was performed using the Student's t-test using the SPSS program (Ver. 18, PASW ^ⓡ Statistics). A p-value less than 0.05 was considered statistically significant.

As a result, the shortest distance between the apex of the medial aspect and the lower edge of the superficial MCL was 13.29 mm, and the shortest distance between the apex of the lateral aspect and the lower edge of the sagittal base was 12.07 mm. The mean distance between the two sides was 1.03 mm, and the distance between the points on both sides was 72 mm. The inverse tangent values obtained by using this numerical value were 0.92 degrees and the standard deviation was measured to be 1.68 degrees. These results show that the interlinear axis of the present invention has an internal rotation of 0.92 degrees relative to the anatomical phase and the interaxial axis.

It is very important to realize accurate rotational alignment of the femoral component when performing total knee arthroplasty. Clinical Orthop Relat Res. 2000: 72-79; Laskin RS. J Arthroplasty . 1995; 10: 657-7, 1998). The reference axis for implementing the rotational alignment of the distal femur is the tension gap technique 660), posterior condylar line (Hungerford DS, Kenna RV, Clin Orthop Relat Res 1983: 95-107, Laskin RS J Arthroplasty 1995, 10: 657-660), anatomical TEA (Poilvache PL, ( Bone Joint Surg Am. 1987; 69: 873-880), and surgical TEA (Insul JN, Scuderi GR, Font-Rodriguez DE. Clin Orthop Relat Res. 1996: 35-46; Yoshioka Y, Siu D, Asano T, Akagi M, Nakamura T. J Arthroplasty 2005; 20:. 1060-1067; Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS Clin Orthop Relat Res 1993:.. 40-47; Griffin FM, Insall JN, Scuderi GR, J Arthroplasty, 13: 812-815), trochlear AP axis (Arima J, Whiteside LA, McCarthy DS, White SE, J Bone Joint Surg Am 1995; 77: 1331-1334 ; Whiteside LA, Arima J. Clin Orthop Relat Res 1995: 168-172), and the femoral transverse axis (fe moral transverse axis; Victor J, Van Doninck D, Labey L, Van Glabbeek F, Parizel P, Bellemans J. J Bone Joint Surg Br . 2009; 91: 683-690).

Among these, the phase-to-shaft axis has been actively studied as a reliable axis for rotational alignment of the femoral component during total knee arthroplasty, and it has been reported that positioning the femoral component parallel to the axis of the upper and lower tibial joints during tibiofemoral ) And patellar femoral articulation (Miller MC, Berger RA, Petrella AJ, Karmas A, Rubash HE, Clin Orthop Relat Res 2001: 38-45).

The anatomical axis is divided into two parts according to the sulcus and prominence of the medial aspect. Of these, the surgical TEA is more reliable and reproducible than the anatomical TEA in reproducing the rotational alignment Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS, Clin Orthop Relat Res 1993: 40-47).

Although surgical TEA is considered to be the preferred axis of distal femoral rotation, it is difficult to reproduce the operative TEA within the operative field and it is more difficult to identify the groove with the medial femur Yoshino N, Takai S, Ohtsuki Y, Hirasawa Y J Arthroplasty 2001; 16: 493-497). Therefore, much research is under way to find a secondary axis that has a reliable axis, a constant angular relation (small range), and a guide that is easy to identify in the operating room with a small standard deviation.

The tension spacing technique is not appropriate for the reference axis due to natural lateral laxity and tibial incision, and the apical axis of the pulley is not suitable for the reference axis due to the large variability. Anatomical TEA as with the surgical TEA find the exact position within the chapter surgery is difficult (Arima J, Whiteside LA, McCarthy DS, White SE J Bone Joint Surg Am 1995; 77:... 1331-1334; Fehring TK Clin Orthop Relat Res . 2000: 72-79; Laskin RS J Arthroplasty 1995; 10: 657-660; Whiteside LA, Arima J. Clin Orthop Relat Res 1995: 168-172).

In addition, the post-traumatic axis is the most commonly used in the surgical field and is the most commonly used because of the advantage of hard bone markers. However, there is a high likelihood of error in the posterior intercostal axis when the range and standard deviation from the surgical TEA is too large, hypoplasia of the femur, severe bone defect of the internal medicine, or anatomical deformity (Hungerford DS, Kenna RV. Clin Orthop Relat Res . 1983: 95-107).

Victor was analyzed by analyzing several reference axes and reported that the posterior axis was 3 ° inward rotation for surgical TEA, 5 ° inner rotation for anatomical TEA, and 4 ° inner rotation for vertical line of pulley AP axis (Victor J. Orthop Traumatol Surg Res . 2007; 95: 365-372).

Based on this, the ligament axis identified by the present inventors was 0.92 ° inward rotation for anatomical TEA, 1.08 ° external rotation for surgical TEA, and 4.08 ° external rotation for posterior interaxial axis. In addition, the standard deviation was ± 1.68 °. These results show that the interlinear axis of the present invention is a more reliable axis than the interlineal axis and has meaning as a new rotational alignment reference axis. Therefore, the medical guide device of the present invention for confirming the inter-ligament axis can be usefully used for rotational alignment of the femoral component in the case of total knee arthroplasty.

The features and advantages of the present invention are summarized as follows:

(i) The present invention provides a medical guide device for rotational alignment of a femoral component during a total knee arthroplasty.

(ii) The inter-ligament shaft identified in the present invention is a reference axis for easily confirming surgical TEA, which is a reliable shaft for rotational alignment of the femoral component, in the surgical field.

(iii) By using the guide device of the present invention, it is possible to easily identify the inter-ligament axis within the surgical field, and accurate alignment of the femoral component can be performed based on this axis, thereby increasing the probability of success of the total knee arthroplasty.

FIG. 1 is a perspective view of a medical guiding device for rotational alignment of a femoral component according to an embodiment of the present invention.
FIG. 2 is a perspective view from the inside of the medical guide device for rotational alignment of the femoral component according to an embodiment of the present invention.
FIG. 3 is a photograph of a medical guide device for rotational alignment of a femoral implant according to an embodiment of the present invention.
FIG. 4 is a photograph showing the position of the lower end (MCL) of the popliteus tendon and the superficial medial collateral ligament and the inter-ligament axis (blue dotted line) connecting the two points. In total knee arthroplasty, MCL and popliteus tendons were marked with an arrow, and the hypothetical line between these two points was defined as the ligamentous axis, after the knee was bent 90 degrees after distal femoral resection of the femur.
Figure 5 is a photograph showing the trochlear AP axis, anatomical TEA, surgical TEA, and posterior interaxial axis. The distal portion of the femur was viewed from the bottom of the thigh after the three-dimensional CT scan (the same angle as the photograph of FIG. 4).

Exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings, but the present invention is not limited to or limited by the embodiments. For reference, the same numbers in this description refer to substantially the same elements and can be described with reference to the contents described in the other drawings under these rules, and the contents which are judged to be obvious to the person skilled in the art or repeated can be omitted.

FIGS. 1 and 2 are exploded perspective views for explaining the structure of a medical guide device for rotational alignment of a femoral component according to an embodiment of the present invention. FIG. 3 is a perspective view illustrating a rotational alignment of a femoral component according to an embodiment of the present invention. This is a photograph showing a real appearance of a medical guide device for a medical device.

As shown in these drawings, the medical guide apparatus 10 according to the present invention includes a first guide member 100 and a second guide member 200. As shown in Fig.

The first guide member 100 includes a linear body 110 having a sliding member S on its one side in the longitudinal direction and a first transverse member 120 provided on one end of the linear body 110.

The sliding member S is longitudinally provided along one side of the straight body 110 so that the second guide member 200 can slide in the longitudinal direction. The sliding member S may be formed with various known means and structures so that the second guide member 200 can be inserted and slide.

For example, for convenience of manufacture, the sliding member S may have a simple structure, and may have a structure as shown in the drawings, for example.

The first strapping member 120 functions to bind to one of the lower edge of the sagittal base portion and the superficial medial collateral ligament (hereinafter referred to as "soft tissue marker") exposed to the knee (knee joint) do. For this purpose, it is sufficient that the structure of the first stretcher member 120 can be attached to the soft tissue marker.

The position of the lower edge of the sagittal base portion and the superficial medial collateral ligament and the ligament between them are shown in Fig.

For example, the first strapping member 120 may have a rod shape.

As another example, the first stretching member 120 may have a bar shape whose end is bent at a predetermined angle (or whose end can be bent at a predetermined angle), and the bent region (or the first stretching member) And then bending the end at an angle) to securely fasten to the soft tissue marker.

A whitesite reference line reference bar 130 may further be provided on one surface (upper surface or lower surface) of the straight body 110. Referring to FIG. 5, the pulley AP axis is a line connecting a trochlear notch and an intercondylar notch, and is commonly referred to as a whiteside's line. The whiteside line is known to form an angle of 90 degrees with the rotational alignment of the femoral implant. Thus, when applying the device of the present invention to the ligamentous axis, the relationship between the whiteside reference line reference bar 130 and the whiteside line can be referred to.

For example, the angle between the whitesite reference line reference bar 130 and the straight body 110 is substantially perpendicular.

The second guide member 200 includes a straight plate 210 and a second stretch member 220 provided at the other end of the straight plate 210 and attached to one of the soft tissue markers.

One end of the linear plate 210 is inserted into a sliding member S provided in the first guide member 100 to perform sliding motion in the longitudinal direction. The entire length of the medical guide device 10 of the present invention can be freely adjusted through the sliding movement of the linear plate 210. Accordingly, even if the distance between the soft tissue markers is different for each patient, (10) can be used to identify the ligament axis.

The linear plate 210 may have a scale on the surface along the length direction. These scales can be provided at predetermined intervals (for example, mm) as needed, and the distance between soft tissue markings can be easily grasped through scales.

The linear plate 210 may further include a fixing member 230 for fixing the sliding member S on the sliding member S. The fixing member 230 may use any known stopper means capable of preventing and fixing the sliding movement of the linear plate 210, and is preferably located outside the linear plate 210.

For example, a screw may be used as the fixing member 230.

The second sagittal member 220 functions to bind to one of the soft tissue markers exposed to the knee (knee joint) at the time of total knee arthroplasty, like the first sagittal member 120. For this purpose, it is sufficient that the structure of the second squeezing member 220 can be attached to the soft tissue mark like the first squeezing member 120.

The second stretcher member 220 may have the same material and shape as the first stretcher member 120, but in some cases, the first and second stretcher members may be configured to have different materials and / or shapes have.

The first guide member 100 and the second guide member 200 can be manufactured using a metal (e.g., iron, aluminum, etc.), plastic, alloy, or the like that is usable for medical use.

Hereinafter, how the medical guide apparatus 10 of the present invention described above is used in a total knee arthroplasty (right knee joint) will be described.

In order to accurately align the rotational alignment of the femoral component in a total knee arthroplasty, it is necessary to identify the axis as the reference for the rotational alignment in the operative field. As such a reference axis, the present inventors newly discovered and identified a reliable axis (inter-ligament axis) connecting the two soft tissue markers.

In order to confirm the axis between the ligaments, the patient's knee is first incised, the distal femur is cut, and the knee is bent to about 90 degrees. The first engaging member 120 provided at one end of the first guide member 100 is engaged with the lower edge of the superficial inner collateral ligament and then the sliding movement of the linear plate 210 of the second guide member 200 is performed, The second squeezing member 220 is fastened to the lower edge of the base of the sling.

The fixing member 230 is used to fix the linear plate 210 on the sliding member S so that the linear plate 210 is not moved any more when the second elastic member 220 is fully engaged. At this time. The distance between the ligaments (distance between soft tissue markers) can be easily grasped from the scale shown on the straight plate 210, if necessary. By obtaining the interlobular axis through this process, a rotational alignment parallel to the surgical TEA can be obtained, which can reflect the precise rotational alignment of the femoral component.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the same is by way of illustration and example only and is not to be construed as limiting the scope of the present invention. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

10: medical guide device 100: first guide member
110: straight body S: sliding member
120: first spacer member 130: whiteside reference line reference bar
200: second guide member 210: straight plate
220: second stretching member 230: fixing member

Claims (5)

A straight body having a sliding member provided on its one surface in the longitudinal direction,
A first guide member provided at one end of the rectilinear body and having a first strapping member which is fastened to a lower edge of a popliteus tendon origin or a superficial medial collateral ligament; And
A straight plate having one end inserted into the other end of the straight body and sliding in the longitudinal direction on the sliding member,
And a second guide member provided at the other end of the linear plate and including a second engaging member which is engaged with a lower edge of the tendon base or superficial inner side ligament,
When the first stretch member is fastened to the lower edge of the sagittal base portion, the second stretch member is fastened to the lower edge of the superficial internal collateral ligament. When the first stretcher member is fastened to the lower edge of the superficial internal collateral ligament, Wherein the second transverse member is engaged with the lower edge of the base of the slat and the base of the slat, and guiding the rotational alignment of the femoral implant in the case of total knee arthroplasty.
2. The medical guide device according to claim 1, wherein the linear plate of the second guide member is marked with a scale on its surface along the longitudinal direction.
The medical guide apparatus according to claim 1, wherein the linear plate of the second guide member is provided with a fixing member for fixing the linear plate on the sliding member.
The medical guide device according to claim 1, wherein the straight body further comprises a whitesite reference line reference bar on one side.
2. The medical guide device according to claim 1, wherein the first and second straining members are engaged at the bottom edge of the saddle-like base portion or superficial medial collateral ligament exposed at the 85-95 degree bent knee.

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