| US20150057750A1 | 2015-02-26 | |||
| CN107280809A | 2017-10-24 | |||
| US6752830B1 | 2004-06-22 |
FERRARI, M. B. ET AL.: "Medial Patellofemoral Ligament Reconstruction in a Revision Setting: Anchor and Interference Screw Fixation", ARTHROSCOPY TECHNIQUES, vol. 6, no. 4, pages e927 - e932
MCGEE, R. ET AL.: "Patellar Tendon Graft Anterior Cruciate Ligament Reconstruction Technique With Suture Tape Augmentation", ARTHROSCOPY TECHNIQUES, vol. 8, no. 4, 4 March 2019 (2019-03-04), pages e355 - e361
| Claims We claim: 1. A surgical kit comprising: a patellar tendon graft having a femoral end, a tibial end, a tendinous portion, femoral bone plug and a tibial bone plug, a FiberLoop Suture with a straight needle, a FiberTape suture, a Bone-Tendon-Bone Tightrope, an interference screw, a SwiveLock anchor, a 9 mm oscillating saw blade, a Rongeur, a needle driver, suture scissors, 1.5 mm drill bit, and a drill. 2. The surgical kit of claim 1 contained within a sterile package, the sterile package being selected from the group consisting of a sealed tray, a sealed bag, a sealed metal foil bag, a sealed plastic bag, a sealed plastic tray, a sealed metal tray, and a metal foil-sealed plastic or metal tray. 3. A method of making a surgical implant comprising: providing a patellar tendon graft having a femoral end, a tibial end, a tendinous portion, femoral bone plug and a tibial bone plug, shaping the femoral bone plug into a first cylinder and the tibial bone plug into a second cylinder, drilling a medial to lateral drill hole in each of the femoral bone plug and the tibial bone plug, providing a braided suture in the form of a continuous loop and attached to a Keith needle having a Nitinol loop, securing the braided suture to the graft by passing the braided suture around the tendinous portion of the tibial end of the graft, making at least two passes with the Keith needle and braided suture through the tendinous portion, and passing the Keith needle through soft tissue on a posterior aspect of the tibial bone plug and out through the tibial end thereof which serves as a passing or shuttle suture, detaching the Keith needle from the braided suture while keeping the Nitinol loop intact, placing the Keith needle through the medial to lateral drill hole in the femoral bone plug and maintaining the Keith needle there as a reference, drilling an anterior to posterior hole in the femoral bone plug immediately beneath and perpendicular to the Keith needle located in the medial to lateral drill hole, passing a flat-braided suture through the medial to lateral hole of the femoral bone plug using the Keith needle as a shuttle, slightly bending the Keith needle with a needle driver, passing a first end of the flat-braided suture using the Keith needle through a junction of the femoral bone plug and the tendinous portion and out through a junction of the tibial bone plug and the tendinous portion, with the Keith needle extending parallel to fibers of the tendinous, passing a second end of the flat-braided suture using the Keith needle through the junction of the femoral bone plug and the tendinous portion and out through the junction of the tibial bone plug and the tendinous portion, with the Keith needle extending parallel to fibers of the tendinous, passing the first end of the flat-braided suture and the second end of the flat-braided suture through the medial to lateral drill hole in the tibial bone plug in a crisscross fashion, and passing bone to bone fixation suture assembly through the anterior to posterior hole in the femoral plug and operatively coupling the bone to bone fixation suture assembly to the graft thereby forming an interlocking loop between the flat-braided suture and the bone to bone fixation suture assembly. 4. A method of storing the surgical implant of claim 3 comprising: placing the surgical implant in a sterile package, the sterile package being selected from the group consisting of a sealed tray, a sealed bag, a sealed metal foil bag, a sealed plastic bag, a sealed plastic tray, a sealed metal tray, and a metal foil-sealed plastic or metal tray, followed by cooling the surgical implant. 5. The method of claim 4 comprising freezing the surgical implant at -20 ± lO°C. 6. A method of transporting the surgical implant of claim 3 comprising: placing the surgical implant in a sterile package, the sterile package being selected from the group consisting of a sealed tray, a sealed bag, a sealed metal foil bag, a sealed plastic bag, a sealed plastic tray, a sealed metal tray, and a metal foil-sealed plastic or metal tray, freezing the surgical implant, placing the surgical implant in a transportable cooler, and transporting the surgical implant within the transportable cooler. 7. A surgical implant comprising; a patellar tendon graft having a femoral end, a tibial end, a tendinous portion, femoral bone plug and a tibial bone plug, wherein the femoral bone plug is shaped into a first cylinder and the tibial bone plug is shaped into a second cylinder, a medial to lateral drill hole formed in each of the femoral bone plug and the tibial bone plug, a braided suture provided in the form of a continuous loop and attached to a Keith needle having a Nitinol loop, a braided suture in the form of a continuous loop secured to the graft by passing the braided suture around the tendinous portion of the tibial end of the graft, passing the braided suture through the tendinous portion, and passing braided suture through soft tissue on a posterior aspect of the tibial bone plug and out through the tibial end thereof, an anterior to posterior hole formed in the femoral bone plug immediately beneath the medial to lateral drill hole therein, a flat-braided suture passed through the medial to lateral hole of the femoral bone Plug, a first end of the flat-braided suture passed through a junction of the femoral bone plug and the tendinous portion and out through a junction of the tibial bone plug and the tendinous portion, a second end of the flat-braided suture passed through the junction of the femoral bone plug and the tendinous portion and out through the junction of the tibial bone plug and the tendinous portion, the first end of the flat-braided suture and the second end of the flat-braided suture passed through the medial to lateral drill hole in the tibial bone plug in a crisscross fashion, and a bone to bone fixation suture assembly passed through the anterior to posterior hole in the femoral plug and operatively coupled to the graft thereby forming an interlocking loop between the flat-braided suture and the bone to bone fixation suture assembly. 8. A surgical kit comprising the surgical implant of claim 7. 9. The surgical kit of claim 8 including at least one interference screw and at least one bone anchor. 10. The surgical implant of claim 7 stored within a sterile package, the sterile package being selected from the group consisting of a sealed tray, a sealed bag, a sealed metal foil bag, a sealed plastic bag, a sealed plastic tray, a sealed metal tray, and a metal foil-sealed plastic or metal tray. |
USING SUTURE TAPE AUGMENTATION
Cross Reference to Related Application
This application claims benefit to U.S. Provisional Application No. 62/756,298 filed on November 6, 2018, titled“Patellar Tendon Graft And Anterior Cruciate Ligament (ACL) Reconstruction Method Using Suture Tape Augmentation” the entire contents of which are incorporated herein.
Technical Field
Suture tape augmentation for repair and in combination with reconstruction with grafts has been described for multiple procedures. To date, there has not been a description of a patellar tendon graft anterior cructiate ligament reconstruction using an augmented graft. The present invention is directed to patellar tendon graft and method of incorporating a cross-linked suture tape into same for use in ACL reconstruction surgery.
Background and Summary of the Invention
The use of suture materials to augment knee, elbow, and ankle ligament procedures has been recently described. Biomechanical studies have shown that such suture materials provide additional strength. 1,2 ’ 3 12 One of the most common procedures performed in orthopedics is reconstruction of the anterior cruciate ligament or ACL, with greater than 100,000 performed annually in the US. 4 Despite significant advancements in surgical technique and physical therapy, graft rupture and inability to return to sports are still significant issues. 5 Techniques have been described for reinforcing soft tissue grafts with a suture tape material (see FIG. 10). 6,7 The present invention presents a technique for ACL reconstruction using a patellar tendon graft augmented with a cross linked suture tape. A cortical button is used for fixation on the femoral side. Either a button or interference screw plus suture anchor can be used for the tibial side fixation. The novel aspect of the technique is the graft preparation, which, to our knowledge, has not been previously described. Detailed Description of the Invention
Materials
This technique can be used with either a patellar tendon autograft or allograft (FIGS. 2B and 1 1 A and 11B). Other items that are used in this graft augmentation are a FiberLoop Suture (FIGS. 12A and 12B) with a straight needle, a FiberTape suture (FIGS. 13A and 13B), and the Bone-Tendon-Bone (BTB) Tightrope (FIGS,. 14A and 14B) (all products from Arthrex, Naples, FL) (FIG. 1). There are multiple options for fixation on the tibial side, all of which can be used with this technique. Preferably, an interference screw (FIG. 15) is used along with a SwiveLock anchor (FIG. 16) (Arthrex, Naples, FL). The surgeon or assistant will also want to have available the following: 9 mm oscillating saw blade, a power unit such as Stryker’s Total Performance System (TPS) (FIG. 17), a Rongeur, a needle driver, suture scissors, a 1.5 mm drill bit and a drill.
The present invention contemplates a pre-made, sterile surgical kit or tray including one or more of the items described above and shown in FIGS. 1A, 1B, 11 A, 11B, 12A, 12B, 13, 14, 15, 17, 18 and 19. For example, the surgical kit may include a patellar tendon allograft, a FiberLoop suture, a FiberTape suture and a BTB TightRope button (FIG. 18). The surgical kit may include a patellar tendon allograft (FIG. 9C) including a cross-linked suture tape and prepared as described herein (FIGS. 3A through 9B).
Surgical Technique
Patient Position. The patient is placed supine on the table. A lateral post (Shutt Universal Stress Post, Conmed, Inc.) is positioned 3-4 finger breaths superior to the patella. A sandbag is taped to the bed so that the foot can rest against it with the knee at 90 degrees of flexion (for harvesting an autograft). If an allograft is being used, no sandbag is necessary. A tourniquet is placed on the upper thigh and inflated to 250 mm Hg. The leg is prepped and draped in sterile fashion.
Incision and Graft Harvest. For an autograft, an anterior midline incision is made from the inferior pole of the patella to the tibial tubercle. 13x18 mm Smillie retractors with a down curve are used for exposure of the tendon. The central third of the patella is harvested. Preferably, a 10 or 11 mm wide portion of the middle of the tendon is taken. Using a 9 mm oscillating saw, an 18 mm bone plug is taken from the patella and the tibia. An 8 mm mini Lambotte osteotome is used on the patella and a curved ¼ inch osteotome is used on the tibia. The graft is then prepared on a back table.
For an allograft, standard anterolateral and anteromedial arthroscopy portals are made and an incision is made on the proximal tibia for the tibial tunnel. The graft can be prepared prior to performing the arthroscopy.
Graft Preparation. The surgeon or assistant can prepare the bony ends of the graft in typical fashion. Preferably, a rongeur is used to shape the femoral sided bone plug into a cylinder (FIG. 2) that is 10 mm in diameter and 18 mm in length. The tibial side is prepared similarly. An oscillating saw may also be needed in prepping the bone blocks. The preferred tendon width is typically 10 mm or 11 mm.
A & B) The BTB TightRope is passed through the anterior to posterior drill hole in the femoral side bone plug. C) The graft prep is completed with the BTB TightRope button,
FiberTape suture and FiberLoop suture in place as described.
It is contemplated that an allograft, as described above and shown in FIG. 9C, may be sterilely fabricated and sterilely packaged within a bag, tray or pouch for storage, transportation and later use. Such allografts can be made by a skilled technician in a laboratory, away from the operating room, and without any time constraints of the type that may affect the quality of the graft when, for example, augmenting an autograph in an operating room environment immediately before surgery. Exemplary packaging may include a plastic or metal tray having a peal-away metal foil or plastic lid for sealing the tray, a seamless plastic or metal foil bag or a sealed glass, plastic or metal bottle having a removable, screw-type lid.
Arthroscopy and Tunnel Drilling. An arthroscopy of the knee is performed and all compartments are examined. Any concomitant injuries are addressed. The ACL is debrided using a 5.0 mm arthroscopic shaver. Notchplasty is only performed in cases of a narrowed or“A-frame” type notch. Otherwise, only the soft tissue is removed from the bone. Care is taken to debride back to the posterior-most aspect of the femoral condyle. A small window in the periosteum is made on the proximal anteromedial tibia and the tibial drill guide is placed into the medial portal, set at 60 degrees. This allows for a long enough tunnel to provide excellent“graft-tunnel match” and ensure that no bone from the tibial bone plug is outside the tibial tunnel once the graft is passed through and secured. A guidepin is passed through the tibial guide and into the center of the ACL insertion footprint. The guide is then removed and an 11 mm reamer is passed over the guidepin. The shaver is used to remove any excess bony and soft tissue debris around the tibial tunnel that could impede passage of the graft. A rasp is used to smooth any bony spicules within the tunnel, again for ease of graft passage.
The arthroscope is then transferred to the medial portal to visualize the femoral origin. The FlipCutter guide (FIG. 19) is passed through the lateral portal and placed onto the center of the ACL origin (Arthrex, Naples, FL). The preferred guide has a 7 mm offset that hooks onto the posterior femoral condyle. The guide handle is elevated approximately 20 degrees from parallel to the floor and set to 105 degrees. A small incision is made with an 11 blade on the lateral side of the thigh and the drill sleeve is advanced to contact the lateral femoral cortex. The drill is passed through the lateral femur and will be seen to enter the joint through the guide positioned at the femoral origin. Once the drill pass has been made, the sleeve with its 7 mm nipple are malleted into positon, engaging into the lateral femur. The flip mechanism is engaged and the tunnel is created by pulling back with the drill, but reaming in the forward direction. The surgeon can use one hand on the drill and use the other hand to firmly hold the drill sleeve in place. The surgeon’s thumb can be placed on the drill sleeve and the fingers can grasp the thigh - this ensures that the drill sleeve will remain in place until the tunnel has been reamed.
The FlipCutter (Arthrex, Naples, FL) is advanced back into the joint and the tip is flipped to allow for removal of the drill. At this point, a shaver can be placed into the tibial tunnel and into the joint for suctioning of any bony debris. The fluid should be turned off, the drill removed, and a FiberStick (FIG. l9)( Arthrex, Naples, FL) suture is passed through the femoral drill sleeve and into the joint. Using a loop grasper held upside down, and advanced into the tibial tunnel, the shuttle suture widthing the FiberStick can be retrieved out of the tibial tunnel.
The graft is then shuttled into positon and the button is secured on the lateral femoral cortex. An X-ray can confirm the appropriate position of the button. The white sutures of the TightRope are then toggled to pull the graft into the tunnel. The femoral bone plug sometimes has to be manipulated with a probe to pass the top part of the tibial tunnel. Also, the tibial bone plug should be positioned in line with the tibial tunnel before the graft has been advanced too far.
Once the graft is securely in position, a final X-ray confirms the button is secured against the lateral femoral cortex. A posterior drawer tension is applied to the knee and an interference screw (typically a 10x 23 mm screw) is placed into the tibial tunnel. The tails of the FiberTape are then secured to the tibial with a 4.75 swivel lock anchor.
Post-Op Care. Sterile dressings are applied and the patient is placed in a hinged knee brace locked in extension. The patient can weight bear as tolerated. Our rehab protocol begins the next day with an early emphasis on motion. The patient will then progress through criteria-based phases of rehab. Return to activities are based on time for the graft to incorporated into the tunnels, ligamentization of the graft, satisfactory subjective test scores and physical exam. Finally, the patient must demonstrate return of strength and neuromuscular control with a series of video-taped movements before it is determined they are safe for return to higher level activities. This is followed by a reintegration to sport schedule with a progressive increase in activity and workload. Discussion
A large volume of literature exists on ACL reconstruction and recent studies have focused on graft choice, tunnel placement, and even preservation of the native ligament. 8,9 We have developed a technique to augment the preparation of a patellar tendon graft using a cross-linked high strength suture tape material.
There are several risks and concerns that we have in using this graft technique despite the fact that rotator cuff repair has been performed using this same suture material for several years without any reported adverse reactions to the suture material. 11 It is not established that the suture material used in our preparation will have no effect on the knee joint. It is possible that any suture that remains intra-articular could cause a recurrent effusion or other reaction. We created a way to have the suture entirely within the substance of the graft, but time will tell if there is any subset of patients that may have a reaction to it. We have not observed this so far in our patients.
An additional concern is what effect the suture would have on the properties of the graft, if any. It is possible that there could be a negative effect on the ligamentization process that is characteristic in ACL reconstructions. This has not been a complication noted in other applications of the suture tape, but it has also not been specifically studied with a patellar tendon autograft or allograft. There has yet to be biomechanical testing performed to evaluate where the grafts could fail when they do, which would in turn illustrate potential weaknesses in the construct. Finally, there is concern that the addition of the suture tape material and its fixation may over-constrain the graft, causing stress- shielding. Bachmaier, et al. evaluated soft tissue grafts augmented with suture tape and found that this load-sharing configuration bypasses any stress-shielding effect. 12 Further study will demonstrate if this is also true in an augmented patellar tendon graft.
Ultimately, we were seeking an augmentation to the graft that would increase its mechanical load to failure, and specific testing will determine if it does and if it is statistically significant.
The hope of any of our efforts to improve ACL surgery would be to develop ways to increase the rate of return to sport and reduce the chance of a repeat injury. We would further like to decrease the time to return, if this were possible. Additional study will be needed to see if this graft preparation can be of benefit in any of these categories. As will be apparent to one skilled in the art, various modifications can be made within the scope of the aforesaid description. Such modifications being within the ability of one skilled in the art form a part of the present invention and are embraced by the claims below. For example, it is contemplated that suture materials other than what are disclosed above may be utilized in the invention including other non-absorbable suture types like braided silk, braided nylon, monofilament nylon, number 5 Ticron, number 5 Ethibond, 5 mm Mersilene tape, braided ultrahigh-molecular weight polyester or polyethylene suture or suture tape. It is further contemplated that the graft augmentation technique described above may be used with grafts other than patellar tendon autografts and allografts including, for example, hamstring tendon grafts, quadriceps tendon grafts and Achilles tendon grafts. It is also contemplated that the augmented grafts described above may be used with tendon reconstruction surgeries other than ACL reconstruction surgery including, for example, quadriceps tendon reconstruction and Achilles tendon reconstruction.
References (the entire contents of which are incorporated herein by reference)
1. Smith, PA and Bley, JA. Allograft anterior cruciate ligament reconstruction utilizing internal brace augmentation. Arthroscopy Techniques. 2016; 5: el l43-el l47
2. Dugas, JR, Walters, BL, Beason, DP, Fleisig, GS, and Chronister, JE. Biomechanical comparison of ulnar collateral ligament repair with internal bracing versus modified Jobe reconstruction. American Journal of Sports Medicine. 2016; 44: 735-741
3.Lubowitz, JH, MacKay, G., and Gilmer, B. Knee medial collateral ligament and posteromedial corner anatomic repair with internal bracing. Arthroscopy Techniques. 2014; 3 : e505-e508
4. Buller, LT, Best, MJ, Baraga, MG, & Kaplan, LD. Trends in anterior cruciate ligament reconstruction in the United States. Orthopaedic Journal of Sports Medicine. 2014; 3(1), 2325967114563664.
5. Shah, VM, Andrews, JR, Fleisig, GS, McMichael, CS, & Lemak, LJ. Return to play after anterior cruciate ligament reconstruction in National Football League athletes. The American journal of sports medicine. 2010; 38(11), 2233-2239.
6. Smith, PA and Bley, JA. Allograft anterior cruciate ligament reconstruction utilizing internal brace augmentation. Arthroscopy Techniques. 2016; 5: el l43-el l47
7. Daggett, M., Redler, A., & Witte, K. Anterior Cruciate Ligament Reconstruction with Suture Tape Augmentation. Arthroscopy techniques. 2018.
8. DiFelice, GS, & van der List, JP. Clinical Outcomes of Arthroscopic Primary Repair of Proximal Anterior Cruciate Ligament Tears Are Maintained at Mid-term Follow-up. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2018; 34(4), 1085-1093.
9. DiFelice, GS, Villegas, C., & Taylor, S. Anterior cruciate ligament preservation: early results of a novel arthroscopic technique for suture anchor primary anterior cruciate ligament repair. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2015; 31(11), 2162-2171.
10. Tiefenboeck, TM, Thurmaier, E., Tiefenboeck, MM, et al. Clinical and functional outcome after anterior cruciate ligament reconstruction using the LARS™ system at a minimum follow-up of 10 years. The Knee. 2015; 22(6), 565-568.
11.Hug K, Gerhardt C, Haneveld H, Scheibel M. Arthroscopic knotless-anchor rotator cuff repair: A clinical and radiological evaluation. Knee Surg Sports Traumatol Arthrosc. 2015; 23 :2628-2634.
12. Noonan, BC, Bachmaier, S., Wijdicks, CA, & Bedi, A. Intraoperative preconditioning of fixed and adjustable loop suspensory anterior cruciate ligament reconstruction with tibial screw fixation— An in vitro biomechanical evaluation using a porcine model. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2018; 34(9), 2668-2674. Table 1. Pearls and Pitfalls to Preparation of BTB Tendon Graft for ACL Reconstruction Utilizing Suture Tape Augmentation
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