KR20160034656A - A Phased Curved Dilator System for Forming a Femoral Tunnel in Anterior Cruciate Ligament Reconstruction - Google Patents

Abstract

The present invention relates to a phased curved dilator system for reconstructing an anterior cruciate ligament. The curved dilator system in accordance with the present invention can be used to successfully reconstruct a single bundle anterior cruciate ligament through an anteromedial portal without a problem by a technique and a complication. Since hyperflexion of a knee is not required during an operation, a simpler operation can be performed than a conventional anteromedial portal procedure. An excellent arthroscope image can be obtained through the anteromedial portal, and cartilage damage with the inside of a femur can be avoided. Also, the phased curved dilator system in accordance with the present invention can be used to overcome creation of a short femoral tunnel length which is one of the disadvantages of the anteromedial portal procedure. An inner wall of the tunnel is compressed by phased tunnel dilation to increase bone density around the tunnel.

Description

Technical Field [0001] The present invention relates to an anterior cruciate ligament reconstruction for reconstructing anterior cruciate ligament (ACL)

The present invention relates to a stepwise bending extension system for forming a femoral tunnel in anterior cruciate ligament reconstruction.

It is well known that anatomical positioning of tunnels in functional reconstruction of the anterior cruciate ligament (ACL) results in functional results and knee stability compared to isometric positioning (1-3 ). Conventionally, the transtibial technique was used to create a femoral tunnel, but there was concern about the ability to position the tunnel at an anatomical location (4-7). To solve these problems, several different methods have been devised, one of which is the anteromedial portal technique. Unlike the tibial tunnel where the femoral tunnel position is limited by the tibial tunnel, it is easy to form the femoral tunnel at the anatomical location because the femoral tunnel can be positioned independently in the anterior medial insertion procedure. It has been shown in several previous articles that tunnels can be formed at the anatomical location compared with the cervical spine using the anterior medial approach (8, 9).

However, there are some disadvantages when using anterior medial approach. For example, when a reamer is passed through a femoral surgeon to form a femoral tunnel, knee flexion is required and the arthroscopic field of view is limited. In addition, despite the knee flexion, there is a high risk of injury to the femoral head and cartilage when the reamer is inserted. There is also the problem that the outlet of the femoral tunnel is formed in the lower part and the back part, the tunnel length is shortened, and the peroneal nerve damage is possible (10-12).

In order to minimize the complications and complications of the anterior medial insertion procedure, the present inventors have developed a new stepwise bending extension system.

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.

The present inventors have tried to develop a tunnel forming system to minimize the problems of the surgical technique and complications in anterior cruciate ligament reconstruction. In anterior cruciate ligament reconstruction, it is necessary to secure a sufficient tunnel length for stable fixation of the graft. Therefore, the present inventors have found that sufficient tunnel length is obtained by bending the distal end portion, and cartilage damage in the distal femoral portion can be avoided The present invention has been accomplished by devising a curved dilator system of the present invention.

Accordingly, it is an object of the present invention to provide a curved dilator system for anterior cruciate ligament reconstruction.

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

The present invention provides a curved dilator system for anterior cruciate ligament reconstruction including:

(i) a handle portion operable by an operator; (ii) a bar-shaped body portion, wherein one end of the body portion is coupled to one end of the handle portion; and (iii) A trocar including a bar-shaped bent portion bent at a predetermined angle with respect to a central axis of the main body portion; And

(b) a handle portion operable by an operator, (ii) a bar-shaped body portion having one end coupled to one end of the handle portion, and (iii) A dilator having a bar-shaped bent portion which is bent at a predetermined angle with respect to the central axis of the body portion,

And the expander is inserted into the tunnel after the trocar needle is inserted into a subject to form a tunnel, thereby expanding the diameter of the tunnel.

The inventors of the present invention have devised a curved dilator system of the present invention as a result of efforts to develop a tunnel forming system for minimizing the problems and complications of the anterior cruciate ligament reconstruction. In anterior cruciate ligament reconstruction, it is necessary to secure a sufficient tunnel length for stable fixation of the graft. When the stepwise flexion expansion system of the present invention is used, a distal end portion is bent to obtain a sufficient tunnel length, It was confirmed that cartilage damage of the distal femur could be avoided.

In the past, the formation of anterior cruciate ligament reconstruction with anterior medial incisal ligament reconstruction (i) caused damage to the medial femoral head, or (ii) the tunnel length was shortened when the tunnel was drilled straight, The inventors have devised a system of the present invention to solve such a problem.

The present invention relates to a system for balancing an anterior cruciate ligament reconstructing a distal end of a trocar and an expander in a curved shape and capable of widening the diameter of a tunnel in a stepwise manner,

Ⅰ. trocar( trocar )

Fig. 1 shows a trocar 100 according to the present invention. The trocar includes a handle portion 110, a body portion 120, and a bend portion 130. The handle portion is operable by manual operation of the operator, and the body portion has a bar shape and is coupled to one end of the handle portion. The bent portion has a curved bar shape and is coupled to the other end of the body portion and exists in a shape bent at a certain angle with respect to the central axis of the body portion. That is, the handle portion is coupled to one end of the body portion, and the bent portion is coupled to the other end.

The curved portion of the trocar is 4 mm to 5 mm in diameter. According to the present invention, the curved portion of the trocar is 4.5 mm in diameter, and the scale is marked to confirm the inserted depth.

According to the present invention, the bend portion of the trocar cap is bent at 10 degrees or 15 degrees with respect to the central axis of the main body portion. The degree of bending of the bending part may vary slightly depending on the shape of the distal femur of the subject. For example, in the case of a woman with a small femur, a trocar with a 15-degree bend may be used.

The trocar is the first tool used to form the femoral tunnel. The end of the flexion is attached to the anterior cruciate ligament with the hammer, and inserted into the inferior medial insertion port of the patient. This creates the most basic tunnel, and the trocar is inserted until it passes through the lateral cortical bone with the lateral femoral outstretch.

Ⅱ. Expander ( dilator )

Figures 2-4 illustrate the expander 200 of the present invention. Like the trocar, the expander includes a handle portion 210, a body portion 220, and a curved portion 230. The handle portion is operable by manual operation of the operator, and the body portion has a bar shape and is coupled to one end of the handle portion. The bent portion has a curved bar shape and is coupled to the other end of the body portion and exists in a shape bent at a certain angle with respect to the central axis of the body portion. That is, the handle portion is coupled to one end of the body portion, and the bent portion is coupled to the other end.

The bend of the expander has a diameter of 6 mm to 10 mm. According to the present invention, the bend of the expander has a diameter of 6 mm to 10 mm.

According to the present invention, the bend portion of the expander is bent by 10 degrees or 15 degrees with respect to the central axis of the body portion. The degree of bending of the bending part may vary slightly depending on the shape of the distal femur of the subject.

The curved portion of the trocar and the expander is inserted through the accessory anteromedial portal of the subject to form or expand a tunnel.

First, after the trocar needle is inserted into a subject to form a tunnel, the expander is inserted into the tunnel to enlarge the diameter of the tunnel. Depending on the size of the tunnel you want to expand, you can use one of the 6 mm to 10 mm diameter expanders in turn (for example, if you make a 9 mm tunnel, you can use it in the order of 7 mm expander, 8 mm expander, 9 mm expander ) On the other hand, if the diameter of the tunnel is widened step by step using the expander, the bone density around the tunnel is increased.

After formation of the femoral tunnel, an endobutton is used to fix the implant. For this purpose, a trocar is used to form a femoral tunnel, starting from the joint of the distal femur to the outer cortical bone, through a narrow tunnel (for passing the endobutton) and then expanding to a distance of 5 mm shorter than the actual tunnel length . In this case, it is necessary to confirm the numerical value for checking the tunnel length.

(Ii) a bar-shaped main body portion, one end of the main body portion being coupled to one end of the handle portion, and (iii) a stepped bending expanding system of the present invention, The apparatus may further include a depth gauge coupled to the other end of the body portion and including a bar-shaped bent portion bent at a predetermined angle with respect to the central axis of the body portion.

According to the present invention, the bend portion of the depth measuring device is bent at an angle of 10 degrees or more with respect to the central axis of the body portion, and the bend portion is bent by about 10 to 15 degrees with respect to the central axis of the body portion. 15 degrees are curved.

The depth meter is used to accurately measure the length of the femoral tunnel.

The average length of the femoral tunnel formed using the stepwise bending extension system of the present invention is about 30 mm to 50 mm. According to one embodiment of the present invention, the length of the femoral tunnel is about 34 mm and 48 mm.

The stepwise bending extension system of the present invention can be used for single or double bundle anterior cruciate ligament reconstruction. It is possible to prevent the occurrence of overlapping of tunnels, rather than to form a straight tunnel, thereby contributing to the reconstruction of a double bundle anterior cruciate ligament.

According to the invention, the device of the invention comprises a trocar cap, a bending expander and a depth measuring device, each comprising a handle portion, a body portion and a bend, wherein the bend has a bend of 10 to 15 degrees with respect to the central axis . The trocar, bend expander and depth finder may be in one device or in sequential use as a "step bending extension system for anterior cruciate ligament reconstruction", each in a separate configuration.

On the other hand, in the present invention, the scale on the bent portion can be expressed in units of cm or mm.

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

(a) The present invention relates to a phased bending extension system for anterior cruciate ligament reconstruction.

(b) Using the bending expansion system of the present invention, a single bundle anterior cruciate ligament reconstruction through the anterior medial incisor without complications and complications of the surgical technique can be successfully accomplished.

(c) Since knee and flexion at the time of surgery are not required, a simple operation can be performed in comparison with the conventional anterior medial approach, superior arthroscopic imaging, and cartilage damage to the femoral head can be avoided.

(d) Using the system of the present invention, it is possible to overcome the short femoral tunnel length generation, which is one of the disadvantages of the anterior medial insertion procedure, and the inner wall of the tunnel is compressed by the stepwise tunnel expansion, thereby increasing the bone density around the tunnel .

Figure 1 shows a 4.5 mm-diameter curved guide trocar 100 included in the device 10 of the present invention. The trocar cap comprises a handle 110, a main body 120, and a curved portion 130.
Figures 2-4 show (i) a 7 mm-diameter bend expander, (ii) an 8 mm-diameter bend expander, and (iii) a 9 mm-diameter bend expander, respectively.
Figure 5 shows a depth gauge.
6 is a view showing a bending expanding device of the present invention. From the left, (i) a 4.5 mm-diameter curved guide trocar, (ii) a 7 mm-diameter curved dilator, (iii) an 8 mm-diameter bend expander, and (iv) Diameter bending expander. Both the trocar and the expander are curved at the insertion end.
FIG. 7 shows a photograph showing a target site for an ACL reconstruction; FIG. AM (anteromedial) portal - anterior medial insertion; Accessory anteromedial portal (AAM)
Figure 8 is a C-arm image to see if the trocar penetrates the lateral femur and distal cortex.
9A and 9B are side and plan views of a depth meter included in the device of the present invention.

Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

Example

Example 1: Fabrication of a bending expansion device for forming a femoral tunnel

Figure 1 shows a 4.5 mm-diameter curved guide trocar 100 included in the device 10 of the present invention. The trocar has a handle 110, a main body 120, and a bent portion 130. This is the first tool used to form the femoral tunnel. The distal end of the anterior cruciate ligament is attached to the femur, and the trocar is inserted with a hammer. Then, a basic tunnel can be formed first by inserting it until it passes through the outer side of the distal femur.

Figures 2-4 show (i) a 7 mm-diameter bend expander, (ii) an 8 mm-diameter bend expander, and (iii) a 9 mm-diameter bend expander, respectively. As shown in FIG. 6, the expander is bent at the distal end portion to be inserted. The expander is used to gradually increase the tunnel diameter along the femoral tunnel formed by the trocar. As the tunnel diameter is enlarged, the bone density around the tunnel is increased.

Figure 5 shows a depth gauge. It is used to measure the tunnel depth after forming the femoral tunnel using the trocar. The distal end is bent at the same angle as the trocar.

After formation of the femoral tunnel, an endobutton is used to fix the implant. For this purpose, use a trocar to form a femoral tunnel, start at the joint with the lateral femur and extend through the narrow tunnel to the cortical bone outside the joint (for endobutton passage), and then extend it 5 mm shorter than the actual tunnel length. Therefore, a scale (numerical value) for checking the tunnel length is needed.

The depth meter is made of stainless steel 304 steel and the handle is made of aluminum. The rest of the instrument was made of stainless steel 630 steel and the handle was made of wood (see Fig. 6).

Example 2: Injection of a graft using a flexion-extension system

(ACL) reconstructive surgery using the device of the present invention within the period from September 2013 to April 2014. The subjects were 17 males and 3 females, aged 16 to 60 years, with an average age of 31.7 years.

Surgical technique

Anterolateral (AL), anteromedial (AM), and accessary anteromedial (AAM) portals were used. The AM portal is made approximately 5 mm more proximal than normal, and the AAM portal is 10 ~ 15 mm inward from the patellar ligaments, distal to the medial meniscus and slightly outside the conventional far medial portal. (See FIG. 7).

For forming the thigh tunnel, an arthroscopic camera was inserted through the AM insertion port, and the device of the present invention was inserted through the AAM insertion port. A drill bit was placed on the anatomic footprint of the ACL and the patient was allowed to pass through the trocar without damage to the medial condyle cartilage Bend and mark your knees. A 4.5 mm-diameter bending guide trocar with a sharp tip was inserted into the marking portion. This was hammered so that the tip of the trocar completely penetrated the lateral condyle cortex (far cortex). At this time, the soft tissues were not damaged as much as possible and only the cortical bone could be drilled. The insertion degree and direction of the trocar tub were confirmed by C-arm (see FIG. 8). The trocar was then removed and the tunnel length was measured with a curved depth gauge. If the tunnel length is too short, the tunnel is redirected again to point higher. In order to enlarge the diameter of the tunnel, a 7 mm-diameter curved dilator was inserted into the center of the tunnel. The expander was inserted into the cortex with hammer 5 mm - 10 mm shorter than the tunnel length. And 8 mm-diameter and 9 mm-diameter expanders were used step by step to match the graft diameter.

For the formation of the tibial tunnel, the insertion point was located 2 cm - 3 cm inward from the tibial tuberosity and above the attachment of the pes anserinus. Using a tibial drill guide, a guide pin was inserted into the tibial plateau at an angle of 55 degrees toward the center of the ACL base. A 9-mm tibial tunnel was formed along the guide pin.

Tendon grafts were passed through the femoral tunnel through the tibial tunnel. An endobutton was used to fix the femoral tunnel, and a bioabsorbable screw was used to fix the tibial tunnel. In addition, a cortical screw was used with a spiked washer.

Parameter measurement

Postoperative complications such as posterior wall blowout and cartilage damage to the medial femoral artery were checked. The femoral tunnel length was measured and peroneal nerve injury was identified during hospital admission.

Test result

In all cases no posterior wall rupture, medial and cartilage damage, and peroneal nerve injury occurred. The average length of the femoral tunnel was 38.4 mm, ranging from 34 mm to 48 mm. The shortest length was 34 mm, which was a length long enough to fix.

Argument

The present inventors have confirmed that a single bundle anterior cruciate ligament reconstruction through the anterior medial incisor can be successfully performed without serious intraoperative complications using the bending expansion system of the present invention. Because knee and flexion are not required for forming the femoral tunnel, a simpler operation can be achieved compared to the conventional anterior intercostal approach. Arthroscopic images through the anterior medial side are better and cartilage damage to the medial side can be avoided. In addition, using the system of the present invention, it is possible to overcome the short femoral tunnel length generation, which is one of the disadvantages of the anterolateral insertion procedure. The formation of a curved tunnel also helps in the reconstruction of a double bundle anterior cruciate ligament. This is because it is possible to prevent the occurrence of overlapping of tunnels by changing the direction of bending of the tunnel. Increasing the density of the tunnel wall is another advantage of the system of the present invention. The gradual use of an expander, not a reamer, clearly indicates that the inner wall of the tunnel is compressed, arthroscopically during surgery.

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.

References

One. Lee MC, Seong SC, Lee S, Chang CB, Park YK, Jo H, Kim CH. Vertical femoral tunnel placement results in rotational knee laxity after anterior cruciate ligament reconstruction. Arthroscopy. 2007 Jul; 23 (7): 771-8.

2. Jepsen CF, Lundberg-Jensen AK, Faunoe P. Does the position of the femoral tunnel affect the laxity or clinical outcome of the anterior cruciate ligament-reconstructed knee? A clinical, prospective, randomized, double-blind study. Arthroscopy. 2007 Dec; 23 (12): 1326-33.

3. Loh JC, Fukuda Y, Tsuda E, Steadman RJ, Fu FH, Woo SL. Knee stability and graft function following anterior cruciate ligament reconstruction: Comparison between 11 o'clock and 10 o'clock femoral tunnel placement. 2002 Richard O'Connor Award paper. Arthroscopy. 2003 Mar; 19 (3): 297-304.

4. Steiner ME, Battaglia TC, Heming JF, Rand JD, Festa A, Baria M. Independent drilling outperforms conventional transtibial drilling in anterior cruciate ligament reconstruction. Am J Sports Med. 2009 Oct; 37 (10): 1912-9.

5. Heming JF, Rand J, Steiner ME. Anatomical limitations of transtibial drilling in anterior cruciate ligament reconstruction. Am J Sports Med. 2007 Oct; 35 (10): 1708-15.

6. Kopf S, Forsythe B, Wong AK, Tashman S, Anderst W, Irrgang JJ, Fu FH. Nonanatomic tunnel position in traditional transtibial single-bundle anterior cruciate ligament reconstruction with three-dimensional computed tomography. J Bone Joint Surg Am. 2010 Jun; 92 (6): 1427-31.

7. Strauss EJ, Barker JU, McGill K, Cole BJ, Bach BR, Jr., Verma NN. Can anatomic femoral tunnel placement be achieved using a transtibial technique for hamstring anterior cruciate ligament reconstruction? Am J Sports Med. 2011 Jun; 39 (6): 1263-9.

8. Dargel J, Schmidt-Wiethoff R, Fischer S, Mader K, Koebke J, Schneider T. Femoral bone tunnel placement using the transtibial tunnel or ACL reconstruction: a radiographic evaluation. Knee Surg Sports Traumatol Arthrosc. 2009 Mar; 17 (3): 220-7.

9. Silvaya, Sampaio R, Pinto E. ACL reconstruction: comparison between transtibial and anteromedial portal techniques. Knee Surg Sports Traumatol Arthrosc. 2011 Aug 18;

10. Nakamura M, Dee M, Shibuya H, Nakamae A, Adachi N, Aoyama H, Ochi M. Potential risks of femoral tunnel drilling through the anteromedial portal: a cadaveric study. Arthroscopy. 2009 May; 25 (5): 481-7.

11. Lubowitz JH. Anteromedial portal technique for the anterior cruciate ligament femoral socket: pitfalls and solutions. Arthroscopy. 2009 Jan; 25 (1): 95-101.

12. Bedie, Raphael B, Maderazoe, Pavlov H, Williams RJ, 3rd. Transtibial versus anteromedial portal drilling for anterior cruciate ligament reconstruction: a cadaveric study of femoral tunnel length and obliquity. Arthroscopy. 2010 Mar; 26 (3): 342-50.

100: Trocar
200: dilator
300: Depth gauge
110, 210, 310:
120, 220, 320:
130, 230, 330:
131, 231, 331: scale

Claims (7)

Curved dilator system for anterior cruciate ligament reconstruction including:
(i) a handle portion operable by an operator; (ii) a bar-shaped body portion, wherein one end of the body portion is coupled to one end of the handle portion; and (iii) A trocar including a bar-shaped bent portion bent at a predetermined angle with respect to a central axis of the main body portion; And
(b) a handle portion operable by an operator, (ii) a bar-shaped body portion having one end coupled to one end of the handle portion, and (iii) A dilator having a bar-shaped bent portion which is bent at a predetermined angle with respect to the central axis of the body portion,
And the expander is inserted into the tunnel after the trocar needle is inserted into a subject to form a tunnel, thereby expanding the diameter of the tunnel.
The system of claim 1, wherein the curved portion of the trocar has a diameter of 4 mm to 5 mm.
The system of claim 1, wherein the bend of the expander is between 6 mm and 10 mm in diameter.
2. The apparatus of claim 1, wherein the stepwise bending and expanding system comprises: (i) a handle portion operable by an operator; (ii) a bar-shaped main body portion having one end coupled to one end of the handle portion, And iii) a depth gauge coupled to the other end of the body portion and including a bar-shaped bent portion bent at a predetermined angle with respect to the central axis of the body portion.
The system according to any one of claims 1 to 4, wherein a graduation is marked on the bent portion.
The system of claim 1 or 4, wherein the bend is bent 10-15 degrees with respect to the central axis of the body.
The system of claim 1, wherein the curved portion of the trocar and the expander is inserted through an accessory anteromedial portal of a subject to form or expand a tunnel.

Images