WO2012129617A1 - Dispositifs de fixation cortico-spongieuse compressive pour chirurgie de reconstruction ligamentaire du genou avec double bande et tunnels fémoral et tibial uniques - Google Patents

Dispositifs de fixation cortico-spongieuse compressive pour chirurgie de reconstruction ligamentaire du genou avec double bande et tunnels fémoral et tibial uniques Download PDF

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WO2012129617A1
WO2012129617A1 PCT/BR2011/000081 BR2011000081W WO2012129617A1 WO 2012129617 A1 WO2012129617 A1 WO 2012129617A1 BR 2011000081 W BR2011000081 W BR 2011000081W WO 2012129617 A1 WO2012129617 A1 WO 2012129617A1
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tibial
femoral
graft
fixation
tunnel
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PCT/BR2011/000081
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English (en)
Portuguese (pt)
Inventor
George Guarany Philot
Antônio Alberto AFFONSO FILHO
Fábio Augusto CAPORRINO
Marcelo Apparicio Fernandes JUSTINO
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Medvale Pesquisa E Desenvolvimento Das Ciências Físicas E Naturais Ltda.
Espaço Dumont Pesquisa E Desenvolvimento Ltda.
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Priority to PCT/BR2011/000081 priority Critical patent/WO2012129617A1/fr
Publication of WO2012129617A1 publication Critical patent/WO2012129617A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0805—Implements for inserting tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1714—Guides or aligning means for drills, mills, pins or wires for applying tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A61B17/8886—Screwdrivers, spanners or wrenches holding the screw head
    • A61B17/8891—Screwdrivers, spanners or wrenches holding the screw head at its periphery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0404—Buttons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0817—Structure of the anchor
    • A61F2002/0823—Modular anchors comprising a plurality of separate parts
    • A61F2002/0835—Modular anchors comprising a plurality of separate parts with deformation of anchor parts, e.g. expansion of dowel by set screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0858—Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone

Definitions

  • ACL rupture is a highly prevalent lesion, with about 200,000 primary surgeries and 20,000 revisions (surgery after re-ligation of a reconstructed ligament) per year in the US 1,2,3 .
  • the first reference to the treatment of ACL injury is from 1900, when Battle reports a case of primary repair, with two-year follow-up and good results 4 .
  • repairing a ligament injury means suturing the ruptured ligament stumps to reconstruct its anatomy. When it comes to ligament reconstruction, this means creating a new structure that produces a function similar to that of the ruptured structure.
  • Mclntosh creates an extra-articular reconstruction with a tape of the tibial ilium tract (TIT), the lateral thigh muscle (known as Mclntosh I).
  • Torg also in 1976, describes the clinical importance of the Lachman maneuver, which evaluates the anterior displacement of the tibia in relation to the femur in the ACL lesion, and is still currently used 17 .
  • Intra-articular reconstruction procedures closer to the anatomical ACL are then sought.
  • Mclntosh modifies his original procedure, and passes a TIT tape, attached to his tibial insertion, over the top position (behind the lateral femoral condyle), into the joint, and back to the tibia in an intra-articular tunnel. Creating the technique of McIntosh II.
  • Campbell used the medial third of the patellar tendon, trapping it in the anterior tibial tuberosity, and passing it through a tibial and femoral tunnel, attaching it to the side of the femur.
  • intra-articular techniques were developed, with two incisions, one in the anterior knee and one in the lateral thigh, and fixation on the post.
  • the concept of the femoral tunnel position is fixed at about two millimeters from the posterior cortex.
  • the clock face metaphor is created, with the femoral tunnel originating between 10 am and noon for the right knee and noon and 2 hours for the left. This position is based on the isometric point of the knee (the one in which, regardless of the position of this joint, the distance between the femur and the tibia will be the same, preventing graft stretching) rather than the anatomical position of the ACL.
  • biomechanical evaluations show that both ACL bands are tense at different times during knee flexion and extension.
  • the medial antero band remains tense during almost the entire range of motion of the knee joint, while the posterolateral band presents tension close to the extension and rotates around the medial antero band, thus being an important rotational restrictor.
  • Double-band reconstruction is closer to the normal anatomy of the anterior cruciate ligament, but is technically more laborious and time consuming, (
  • the new and original proposed devices allow the reconstruction of the ACL through a technique that reproduces the two bands of this ligament, with different and independent tensions, through a single tunnel in the femur and tibia.
  • the first stage of surgery is to select and remove the graft that will replace the ruptured ligament, and prepare it for use.
  • flexor tendons In the case of flexor tendons, the tendons of the semitendineus and gracilis muscle are removed through an anteroid medial incision in the knee. These tendons are cleared of all muscle tissue, leaving only its tendon part. It is then sutured so that the tendon acquires a tubular appearance with a high strength surgical thread.
  • This suturing is performed by means of anchored stitches at each end of the graft, leaving the ends of the suture threads left over, so that there is a double cable of threads at each end of the graft. This is done with the tendon of each muscle separately.
  • the tendon preparation will be the same except that two different colored threads will be used to suture the ends of the tendons. tendons, so that each tendon has a different color at each end.
  • the graft is then subjected to tension, tendon and suture to achieve its full potential for plastic deformation, and to cause any slippage that may exist at the tendon and suture interface, thereby causing the graft to reach its length. maximum before use.
  • the main surgeon While the graft is prepared by an assistant, the main surgeon, through two portals (incisions at the knee joint line), introduces the arthroscope into the knee, makes the joint inventory, and treats the meniscus and cartilage injuries. that are associated with ACL injury, and dries out the ruptured ligament remnants.
  • the second surgical time consists in the confection of the tibial tunnel.
  • a guidewire is positioned across the tibia and a positioning guide may be used for this.
  • a cannulated drill of varying diameter is aligned with the guidewire and pierces the tibial tunnel from the anterior tibial cortex to the intraarticular space. The drill and guide wire are then removed.
  • this tunnel varies with the diameter of the graft that will be used. And in double band reconstructions two tunnels with a diameter of 5 to 7mm are drilled, with outlets in the inserts of the two bands of the ACL.
  • the tibial tunnel will always have a diameter of 11 mm, avoiding considerations about the graft caliber, using the same drilling technique.
  • the 11 mm diameter tunnel encompasses, in a single hole, most of the insertion area of the two bands in the tibia.
  • the third time of surgery is to make the femoral tunnel.
  • a guidewire is positioned at the desired location for the origin of the ACL in the femur, with or without the use of a trans-tibial guide.
  • a cannulated drill of varying diameter aligned with the guide wire pierces the femoral tunnel to the desired depth. The drill is removed and the guidewire may or may not be left attached to the femur, depending on the surgical technique used.
  • this tunnel will always have a diameter of 10 mm and a depth of 30mm. Simplifying, once again, the surgical procedure.
  • the fourth surgical time is to position the graft in the tunnels, which is currently done by traction of the guidewire, attached to the proximal end of the graft, in most types of femoral fixation (interference screw, "Endobutton”, tie in post, "Rigid-Fix”, “Ezlock”, “AperFix”).
  • the graft may be located by a steel wire through the femur and then pulled down through the femoral tunnel, joint and tibial tunnel out of the tibia. The graft hangs on the steel wire, and rises when the ends of the wire are pulled in opposite directions.
  • fixation is made by transverse screws, or "rigid-fix"
  • a specific guide will be used to make the tunnels on the side of the femur so that they cross transversely the already perforated femoral tunnel.
  • the femoral guidewire is left in position; a second cannulated, 4.5mm drill is aligned to it and drills the rest of the femur in addition to the already drilled 30mm tunnel.
  • the guidewire is removed, and the total length of this tunnel is measured.
  • the guidewire is reattached through the tibial tunnel and femur and is carried through the thigh muscles out of the patient.
  • the proximal end of the graft is fixed, which, through traction of the guidewire, rises through the tibia and joint space, entering the femoral tunnel.
  • the new technique uses a variation of this same procedure, which is already known and widely used by surgeons.
  • the fifth surgical time is femoral graft fixation.
  • Pole tying requires an accessory incision on the side of the thigh to fix a screw on the side of the femur, increasing surgical time and surgery morbidity;
  • Transverse, spongy fixation screws are one of the most popular fixations, but require an external guide and an accessory incision in the thigh to make the screw hole so that it crosses the femoral tunnel.
  • This technique in addition to longer surgical times and the accessory lateral approach, depends on the accuracy of the external guide, which if not correct, will not allow the screw to cross the graft, and still has the risk of cutting it at the moment of its placement;
  • Rigid Fix also depends on an external guide, which must position two pins through the center of the graft, crossing the femoral tunnel, leading to the same risks;
  • the proposed femoral fixation device for double-band reconstruction in a single tunnel, allows a secure fixation without the need for accessory lateral access (necessary in the transverse screws and post tie), without depending on the posterior cortex for fixation. (required for jamming screws), and without opening or overturning any mechanism (such as "Endobutton”, anchors, "Ezlock” and "AperFix”).
  • the femoral cortex is capable of resisting 400N per mm of cortical thickness.
  • a standard 4.5mm cortical screw anchored in only one femoral cortex (on one of the femur walls), can support about 2500N 29 .
  • the innovative device will fix by anchoring the femoral cortex with a standard 4.5mm thread. Therefore, the expected resistance to the device is at least 2500N. And this resistance is increased by the spongy fixation to be made on the bone between the end of the tunnel and the anterior cortical wall of the femur, and by the compression of the graft against the tunnel wall when the device enters it.
  • fixation is performed in the anterior cortex or lateral anterum of the femur, without risk of reaching blood vessels or nerves in the posterior knee (which may occur with transverse fixations if the surgical technique is not correct).
  • the device proposed here allows the creation of two bands with a single tunnel and a single fixation, making the procedure faster, simpler, safer, and cheaper.
  • This innovative device fixes the graft near the articular surface, preventing graft movement within the tunnel, preventing enlargement from occurring.
  • the device still keeps the graft away from the screw thread, protecting it.
  • it separates the two graft bundles by the diameter of the device, which places them in the center of the original insertion of the two ACL bands, which are anatomically 10mm apart.
  • the surgical technique for the use of the device is very similar to the conventional femoral fixation techniques, with which surgeons are accustomed, however, it allows the reconstruction of the two ACL bands with a single tunnel, which is the great and distinct differential, without the risk of injuring the graft during fixation, and allows review in a single time.
  • the device despite creating two independent bands in the femur, can be used without any harm in a single band reconstruction while retaining all of its fixation advantages.
  • the last surgical time of reconstruction is to tension the graft and fix it on the tibia.
  • the graft is tensioned through the tibial tunnel, and once the desired tension is reached, the tibia is placed in an anatomical position relative to the femur (because in ligament injury it is forward) and the graft is fixed by the desired method.
  • Post fixation lets the screw head protrude into the medial anterum of the tibia and this can lead to constant patient discomfort.
  • the mobility of the graft within the tunnel increases, allowing its widening 30 .
  • This type of fixation still has the risk of reaching blood vessels in the posterior tibial region when bicortical fixation is performed 33 .
  • Interference screws and "Intrafix" allow the tunnel to be obliterated, reducing the movement of the graft inside, thus reducing the chances of tunnel widening.
  • the interference screw when compressing the graft against the tunnel wall, has the risk of cutting it with its thread.
  • Intrafix also compresses the graft against the tunnel wall, but protects the graft through a bushing around the screw.
  • This groove is intended to guide the device, separating the tibial tunnel into two halves, and is performed shortly after drilling the femoral tunnel, just before placing the graft in the tunnels.
  • the graft cables will be removed at the tunnel entrance, and the tibial fixation device will be introduced into the tibial tunnel, with the aid of a specific instrument, dividing it in two with its central plate, separating a graft cable into each half of the tunnel.
  • the knee should be placed in the position of fixation of the medial anterior band, between 45 and 60 degrees of flexion. And this band will be subjected to a desired tension with the use of a dynamometer.
  • the device By inserting the screw corresponding to this half of the tunnel, the device will expand only from this side, securing the first graft band with bending stress.
  • the central plate of the device resting on the bone around the tunnel, keeps the second graft cable free of pressure.
  • the posterolateral band With the knee positioned between zero and ten degrees of flexion, the posterolateral band is tensioned and fixed in the same manner by the introduction of the second screw, which expands the remaining half of the sleeve.
  • the device proposed here also allows a security fixation, made through a graft tie in a plate that is supported on the cortical tibia, and also attaches to the central dividing plate of the tibial device by means of another tie. With this, the device is anchored in the anterior cortical of the tibia, as well as the graft cables.
  • Figure 01 Exploded perspective view of the femoral fixation assembly
  • Figure 02 Perspective view of the assembled femoral fixation assembly
  • Figure 03 Inverted perspective view of the assembled femoral fixation assembly
  • Figure 04 Exploded perspective view of the tibial fixation device
  • Figure 5 Detail of the connection between the snap-on cover and the compression domes
  • Figure 6 Detail of the mounting of the tibial fixation device and the fit between the central plate of the device and the compression domes;
  • Figure 7 Perspective view of the tendon preparation base
  • Figure 8 Perspective view showing the beginning of tibial tunnel perforation, with positioning of the guidewire;
  • Figure 9 Perspective view showing the beginning of tibial tunnel drilling with the cannulated drill
  • Figure 10 Perspective view showing the tibial tunnel perforation with the cannulated drill piercing the tibial bone
  • Figure 11 Perspective view showing the completed tibial tunnel and placement of the femoral guidewire with the aid of the trans-tibial guidewire;
  • Figure 12 Perspective view showing the trans-tibial femoral guide orienting the guidewire entry point into the femur;
  • Figure 13 Perspective view showing the guidewire running through the entire femur
  • Figure 14 Perspective view showing the guidewire held in the same position as the previous figure, with the removal of the femoral guide and introduction of the cannulated drill to the femur;
  • Figure 15 Lateral view showing the guidewire through the femur and the 10mm cannulated drill bit piercing a 30mm deep tunnel and preserving 2mm of intact bone on the posterior wall of the femur;
  • Figure 16 Side view showing the guidewire held in the same position at the femur, and a 4.5mm cannulated drill bit piercing the remainder of the femur beyond the 30mm tunnel;
  • Figure 17 Sectional view showing detail of the femoral tunnel
  • Figure 18 Perspective view showing introduction of graduated ruler through tibial and femoral tunnels
  • Figure 19 Perspective view showing the two lateral and opposite tears made in the tibial inlet cortical, with detail of the notch;
  • Figure 20 Perspective view showing the guidewire detailing the holes at its distal end and the traction wires of the femoral device
  • Figure 21 Perspective view showing the complementary ends of the wires running through the femoral fixation assembly, returning to the remaining holes of the guidewire, and carried through the tunnels;
  • Figure 22 Perspective view showing fixation of the femoral joint by means of the cortical-cancellous screw pulled by the wires;
  • Figure 23 Perspective view of traction wire removal after fixation of the femoral device
  • Figure 24 perspective view of the femoral joint fixed to the femur with the bands crossing the tibial tunnel, with correct positioning of the screw, capsule and graft, showing detail;
  • Figure 25 Perspective view showing the tibial device in relation to the two graft bands
  • Figure 26 Perspective view showing the tibial device being inserted into the tunnel in relation to the two graft bands and with its central metal plate aligned with the groove made in the anterior tibial cortex;
  • Figure 27 Perspective view showing the tibial assembly coupled to a hammer that fits into the central plate of the tibial assembly;
  • Figure 28 Perspective view showing end of socket hammer showing detail
  • Figure 29 Perspective view showing the tibial joint near the tunnel, being impacted with the aid of a hammer
  • Figure 30 Perspective view showing the placement of screws in the tibial device
  • Figure 31 Perspective view showing the use of a hand-held dynamometer that grasps one of the graft bands by forceps while this graft band is tensioned and independently fixed with the knee flexed;
  • Figure 32 Perspective view showing the use of the same manual dynamometer securing the other graft band through its tweezers while this graft band is tensioned and independently fixed with the knee positioned in a position close to the extension;
  • Figure 33 Perspective view showing the devices in their proper place, showing the excess cut of the bands with scalpel aid
  • Figure 34 Perspective view showing the closure of the graft fixation procedure
  • Figure 35 Perspective view showing reinforcement plate placement, without cutting the excess tendons
  • Figure 36 Perspective view showing the tie-up of the reinforcement plate in the central plate of the tibial device
  • Figure 37 Perspective view showing the end of the procedure detailing the binding of the two graft bands on the reinforcement plate
  • Figure 38 Perspective view showing the tibial puller of the tibial fixation device
  • Figure 39 Perspective view showing details of the tibial extractor
  • Figure 40 Perspective view showing impaction of hammer puller opposite tibia showing detail
  • Figure 41 Perspective view showing the hexagon socket wrench to unscrew the femoral screw
  • Figure 42 Perspective view showing the wrench attached to the femoral screw puller
  • Figure 43 Perspective view showing the femoral screw puller attached to the wrench, removing the femoral screw in detail;
  • Figure 44 Perspective view showing extraction key handling femoral artery and screw connection details.
  • the first device (D1) ie the femoral fixation assembly
  • the first device (D1) is composed of a cortical - cancellous screw (2) coupled to a graft support base (3), which will also compress it against the bone, to be used in the femur.
  • Figures 01, 02 and 03 show the femoral fixation assembly (D1), with its flat-head, flat-head hexagonal slotted screw (2) (6), with a proximal screw thread.
  • variable length for cancellous tissue (R1) (according to the size of the screw) and a distal cortical bone thread (R2), about 4mm in length, these two threads (R1 and R2) being discontinuous.
  • the screw (2) has a hole (7) in the tip for passing the "ethibonde" wires (8) used to pull the device.
  • This screw (2) has its length previously determined by the measuring procedure with a graduated ruler (9) shown in Figure 18. It connects to the support base (3) of the graft (4), which is fixed to the assembly by a sturdy suture (10) as shown in detail in figure 2.
  • the ends of the tendons that form the graft (4) will be sutured with high strength and biocompatible "ethibond n ° 2" or similar wire at their ends with distinct colors (C1 and C2) on opposite sides forming a bundle. double, identified by the different colors in the suture (C1 and C2). Near the vertex of this tendon bundle (4), another bandage is made, with the same thread of different colors in order to mark the tendon cords (E1 and E2) in their part. near the support base (3).
  • the second device (D2) is similar to a wall bushing, but with independent expansion of each of its halves (11), which will make the spongy and compressive fixation of the tibial graft, coupled to a plate (12) fixation in the tibial cortex.
  • FIGs 4, 5 and 6 best demonstrate the second device (D2) of the tibial assembly, which consists of two hexagon socket screws (13), a plug and receive circular cap (14), two wires (15) of " ethibonde "number 5, for securing, a hemisphere divider metal plate (16) and two semi-circular compression domes (11) which function as bushings.
  • the domes (11) must be inclined (a) to be mounted and integrated with the circular cover (14) together with the hemisphere divider metal plate (16).
  • the metal plate (16) has two protrusions (17) distal inclined 0 to 90 in order to fit accurately in the holes (18) of the semicircular dome (11).
  • Figure 6 demonstrates, in detail, the configuration of the domes engagement (11) next to the circular cover (14). This device causes the set to become indivisible when closed in the shape of the tibial fixation set (D2).
  • the devices (D1 and D2) are usable for ligament reconstruction of the anterior cruciate ligament based on known surgical techniques as described below:
  • an incision of about 5 cm is made in the anteromedial region of the tibia, over the insertion of the hamstring muscles, also called goose paw.
  • the tendons of the gracilis and semitendinosus muscles are isolated by dissection, and these tendons are removed for use as a graft (4), with the aid of a tendon puller, an instrument commonly used in this type of procedure.
  • the tendons are then brought to a base (B) for preparation where they are tensioned ( Figure 7).
  • This base (B) allows the alignment of the two tendons, forming the graft (4) which are sutured with high strength wire and biocompatible, "ethibond n ° 2", or similar, at their ends, with distinct colors (C1 and C2) on opposite sides, forming a double bundle, identified by the different colors in the suture.
  • C1 and C2 distinct colors
  • another alignment is made with the same wire of different colors (E1 and E2) in order to mark the tendon cords at this other end, so that they can be individualized. when they are fixed to the femoral tunnel.
  • This tendon bundle is positioned at the base (B) by means of the separator (19) and its tips are attached to two tweezers (20) on the opposite side by their handles (21).
  • the beam at this stage is fixed by the handle (22).
  • the graft (4) should be gradually stretched under the control of a dynamometer (23) through the hook (G) in order to maintain a constant numerical tension while waiting for its use in surgery, ensuring that There is no risk of variation in length and no residual slip at the tendon and suture interfaces. This procedure is called pretensioning.
  • the surgeon makes two skin incisions, about 1 cm, at the knee joint, one medial and one lateral, which will be used for the entrance of the graft. arthroscopy and surgical materials in the knee, since the ligament reconstruction procedure is all performed by arthroscopy.
  • a guide wire (24) with a 3.2 mm diameter drill tip is installed using a bone perforator in the center of the tibial insertion of the anterior cruciate ligament, with or without the aid of a specific guide.
  • the tibial bone (25) is punctured until the tip of the guidewire (24) reaches the articular surface (A) of the tibia (25) through the cartilaginous tissue without advancing to other structures, precisely accompanied by arthroscopic vision. .
  • the guidewire (24) is held in its previous position and a cannulated drill (26) and graduated, 11 mm in diameter, is introduced aligned with it, piercing it. the tibial tunnel (T), as shown in figure 10.
  • a cannulated drill 26) and graduated, 11 mm in diameter
  • both the guidewire (24) and the cannulated drill (26) are removed from the tibia (25), leaving only the tunnel (T), free for the next surgical time.
  • the femoral tunnel guidewire (27) is introduced through the tibial tunnel (T) itself, with or without the aid of the trans-tibial guide (28). , being placed in the femur bone (29) at the desired point for the origin of the anterior cruciate ligament to be reconstructed. This point should be in an isometric position at the knee joint, and should be positioned so that the tunnel to be drilled is about 2 mm from the posterior cortical of the femur.
  • Figure 12 demonstrates the trans-tibial femoral guide (28) orienting the guide wire entry point (30) into the femur (29).
  • the guide wire (27) should traverse the entire interior of the femur bone (29) until it ruptures its anterior cortical surface.
  • Figure 14 demonstrates that the guidewire (27) is held in this same position while the femoral guide (28) is withdrawn, and thereafter, aligned with the guidewire (27), a cannulated and graded drill 10 is introduced. mm in diameter (31). As shown in Fig. 15 this cannulated drill bit 31 will progress around the guidewire 27, drilling a 30mm deep femoral tunnel 29, keeping 2mm of intact bone wall in the posterior region of the femur.
  • FIG.16 the 10mm cannulated drill bit (31) is removed and replaced by another 4.5mm diameter cannulated drill bit (32), also aligned with the guidewire (27), which advances by drilling around it. of this wire until it breaks the anterior cortical of the femur, thus creating the widening of the entire canal left by the guide wire (27).
  • Figure 17 shows, in section, the detail of the femoral tunnel and the diameter of the channel prepared in such a way (33) for later insertion of a screw.
  • a L-shaped graduated ruler 9 is introduced to measure the total size of the femoral tunnel (equal to the sum of the 10mm diameter and 4.5mm ,
  • the next step is to make two opposing lateral (R3) tears in the tibial inlet cortical through the double chisel (34) impacted by the hammer (35), just enough to penetrate the cortical wall of the bone. tibial (see detail of fig.19), creating a notch (R3).
  • a new surgical time begins with the reintroduction of the arthroscope and, under visual control, the graft guidewire (36) is introduced through the tibial tunnel (T), joint and tunnel (T). femoral. This guidewire (36) is pushed toward the femur (29) until it punctures the thigh muscles and skin.
  • the guidewire (36) has at its lower end four holes (F1, F2, F3, F4)). In two of these holes (F1 and F2) two "ethibonde" number 5 wires (8) are introduced for traction of the femoral device by the guide wire (36).
  • the other two ends of the wires (8) pass through the femoral fixation assembly (D1) through the hole (7) at the tip of the cancellous cortical screw (2) already attached to its base (3) and the graft (4), and re-drill the remaining two holes (F3 and F4) of the guide wire (36) (fig.21). Then, the guidewire (36), exposed on the side of the patient's thigh, is pulled by the surgeon through the tibial tunnel and the femur tunnel, leading and exposing on the outside of the thigh the four segments of the " ethibonde "number 5 (8).
  • the graft (4) is attached to the base (3) of the femoral fixation device (D1) by means of a tie (10) with number 2 "ethibonde” wire (Fig.02), seen in detail along with the sutures (E1). and E2) identifying the two graft cables.
  • Figure 3 shows the details of the graft curvature (4) and its attachment to the support base (3).
  • the next surgical time (Fig. 22) is the fixation of the femoral joint (D1) to the femur (29) through the cortical-cancellous screw (2).
  • the screw (2) is pulled by the number 5 "ethibonde" wires (8), externalized on the side of the thigh, and screwed ,
  • the cancellous thread (R1) discontinued with the cortical thread (R2) of the screw (2) will prevent its progression when it reaches the cortical bone. This prevents it from advancing through the cortex beyond the 4mm of its specific bone thread (R2) (the average thickness of this cortical is 4mm), thus preventing the progression of the tip of the screw (2) from disturbing it. the thigh muscles.
  • Figure 24 shows the detail of the correct positioning of the screw (2), support base (3) and graft (4), inside the femoral tunnel (T).
  • the markings (E1 and E2) can be observed through the arthroscope, identifying the two graft bands, called anteromedial and posterolateral, at the entrance of the femoral tunnel (T).
  • the result of this procedure will be the creation of two graft bands (38) by the two tendon bundles attached to the femur (29) which will traverse the joint, replacing the two bands of the ruptured anterior cruciate ligament.
  • bands (38) will pass through the tibial tunnel (T), and will exit through the entrance hole in the anterior tibial cortex (25), being apparent from the outside (T) of the Tibial tunnel.
  • the metal plate (16) has two distal protrusions inclined at 90 0 (17) so as to fit accurately in the holes (18) of the semicircular dome (11).
  • This configuration allows the assembly to be introduced into the tibial tunnel (25) without the hemisphere-dividing metal plate (16) disengaging from the intended direction.
  • the tibial fixation assembly (D2) is pressed close to the existing tibial tunnel, aligning the hemisphere-dividing metal plate (16) with the two slots (R3) at the entrance to the tibial tunnel ( fig.26).
  • the tibial fixation assembly (D2) is impacted with the aid of a hammer (39) of ,
  • Figure 29 demonstrates the impaction of the tibial joint (D2) into the tunnel with the aid of a hammer (35) and hammer (39). This impaction should be sufficient to conceal the entire tibial fixation assembly (D2) within the tibial tunnel (T) flush with the external face of the tibia (25).
  • the screws (13) are responsible for the fixation and constant pressure of the two graft bands close to the spongy wall of the tibial bone (25), separated by the hemisphere dividing metal plate (16), in two bands ( 38) distinct within a single tunnel (T) with independent voltages.
  • a manual dynamometer (41) With the knee between 45 and 60 ° of flexion (fig.31), a manual dynamometer (41) is used that holds the anteromedial band of the graft through its forceps and handle (42), identified by marking through a color suture. (C1), referring to its position, and allowing its identification, both inside the joint, near the femoral fixation (E1), and outside the tibial tunnel.
  • the first screw (13) is tightened with the hexagonal tibial wrench (43), the force vector direction can be observed in the second image of figure 31.
  • suture (C2 and E2) by firmly tightening its corresponding screw (13) with the hex wrench (43) after subjecting this band to the desired tension with the dynamometer (41).
  • the excess of the band ends (38) is cut with the scalpel (44) (fig.33), and the ethibond auxiliary wires are removed (15). ) from inside the tibial fixation assembly (D2).
  • the graft fixation procedure is completed, as shown in the drawing in figure 34.
  • Surgical wound closure and surgical wound dressing are performed according to standard techniques.
  • a reinforcement accessory is used to ensure that the tibial joint (D2) does not slip into the tibial tunnel (T), nor the tendons that form the two bands (38).
  • FIG.35 the excess tendon cut-out is not cut as in Fig. 33.
  • a four-hole rectangular cortical support plate (12) is used through which the four ends of number 5 ethibonde wires (5) pass through. 15) which are attached to the hemisphere divider metal plate (16) of the tibial fixation device (D2).
  • a triple knot (45) is then made in each pair of wires over the cortical support plate (12), as shown in figure 36.
  • the tibial device (D2) attaches to the support plate.
  • cortical (12) which rests on the tibial cortex, prevents the migration of the joint into the tunnel.
  • the surgical wound is closed and the surgical wound is dressed according to the usual techniques.
  • the tibial puller (46) will be used, composed of a handle with an impact resistant quadrangular longitudinal bar (fig. 38), with holes coinciding with the two holes of the circular cover (14).
  • the bar Through the holes of the bar are introduced two puller pins (47), which will be screwed into the exit holes of the safety "ethibonde” (15).
  • These pins are knurled at one end and have the self-tapping end at the other to initiate threading in the circular cap (14).
  • the pull-out pin has a hexagonal recess in its head to accommodate the hexagonal wrench (43), which allows it to force the opening of its retaining thread through its self-tapping ends (48), as shown in figure 39. .
  • Fig. 40 demonstrates the impact of the hammer (35) on the tibial puller (46), which extracts the tibial assembly (D2), through the puller pins (47).
  • a hexagon socket wrench (49) will be introduced to unscrew the femoral screw (2) until its inner face is more than 5mm back from the component capsule (3) femoral (D1) (fig.41). Then the hexagon socket wrench (49) is removed from the knee, and the femoral screw extractor (50) is introduced to grasp the inner face of the screw head (fig.42). The hex wrench (49) is then inserted, this time into the screw puller, engaging the screw head and puller cable to form a single screw-puller assembly, facilitating removal with rotation and pull in the withdrawal direction (fig.43). See detail in figure 43 of the screw fitted to the puller and the wrench. This prevents the screw from falling into the joint during its removal.
  • Figure 44 shows the management of the femoral extraction key (49), the extractor (50) and details of its connection to the screw (2).

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Abstract

L'invention concerne des dispositifs (D1 et D2) de fixation cortico-spongieuse compressive. Le dispositif (D1) est utilisé pour la fixation fémorale et l'autre dispositif (D2) pour la fixation tibiale, les deux trouvant une application en chirurgie de reconstruction ligamentaire du ligament croisé antérieur (LCA) du genou, en double bande avec tunnel tibial et fémoral unique. L'ensemble de fixation fémorale (D1) comprend une vis (2) cortico-spongieuse à tête plate, avec fente hexagonale et corps lisse (6), présentant un filetage proximal de longueur variable pour le tissu spongieux et un filetage distal pour l'os cortical (R1 et R2). La vis (2) possède un orifice (7) en extrémité pour le passage de fils (8) et est reliée à la base de logement (3) des tendons (4). L'ensemble de fixation tibiale comprend deux vis de section hexagonale (13), un couvercle (14) circulaire d'emboîtement et réception, deux fils (15) pour fixation de sécurité, une plaque métallique (16) séparatrice d'hémisphères et deux dômes semi-circulaires (11) de compression, qui font office de garnitures. La plaque métallique (16) possède deux saillies (17) distales inclinées à 90° de manière à venir s'emboîter dans les orifices (18) des dômes semi-circulaires (11).
PCT/BR2011/000081 2011-03-28 2011-03-28 Dispositifs de fixation cortico-spongieuse compressive pour chirurgie de reconstruction ligamentaire du genou avec double bande et tunnels fémoral et tibial uniques WO2012129617A1 (fr)

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US9056003B2 (en) 2013-01-25 2015-06-16 Smith & Nephew, Inc. Tissue graft fixation
CN105055048A (zh) * 2015-09-19 2015-11-18 施晓明 交叉韧带重建术滑翔伞状固定板装置
EP3020372A1 (fr) * 2014-10-23 2016-05-18 DePuy Synthes Products, Inc. Outils d'administration d'une ténodèse sur un biceps
EP3020371A3 (fr) * 2014-10-23 2016-08-24 DePuy Synthes Products, Inc. Implants de ténodèse de biceps et outils de livraison
US9693856B2 (en) 2015-04-22 2017-07-04 DePuy Synthes Products, LLC Biceps repair device
US10231824B2 (en) 2016-04-08 2019-03-19 Medos International Sárl Tenodesis anchoring systems and tools
US10231823B2 (en) 2016-04-08 2019-03-19 Medos International Sarl Tenodesis implants and tools
US10729419B2 (en) 2014-10-23 2020-08-04 Medos International Sarl Biceps tenodesis implants and delivery tools
US10751161B2 (en) 2014-10-23 2020-08-25 Medos International Sárl Biceps tenodesis anchor implants
US10856966B2 (en) 2014-10-23 2020-12-08 Medos International Sarl Biceps tenodesis implants and delivery tools

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US9463086B2 (en) 2013-01-25 2016-10-11 Smith & Nephew, Inc. Tissue graft fixation
US9056003B2 (en) 2013-01-25 2015-06-16 Smith & Nephew, Inc. Tissue graft fixation
US10076374B2 (en) 2014-10-23 2018-09-18 Medos International Sárl Biceps tenodesis delivery tools
US11576769B2 (en) 2014-10-23 2023-02-14 Medos International Sarl Method for anchoring biceps tenodesis
EP3020371A3 (fr) * 2014-10-23 2016-08-24 DePuy Synthes Products, Inc. Implants de ténodèse de biceps et outils de livraison
EP3020372A1 (fr) * 2014-10-23 2016-05-18 DePuy Synthes Products, Inc. Outils d'administration d'une ténodèse sur un biceps
US11622848B2 (en) 2014-10-23 2023-04-11 Medos International Sarl Biceps tenodesis anchor implants
US10034742B2 (en) 2014-10-23 2018-07-31 Medos International Sarl Biceps tenodesis implants and delivery tools
US10869751B2 (en) 2014-10-23 2020-12-22 Medos International Sarl Biceps tenodesis implants and delivery tools
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US11284877B2 (en) 2014-10-23 2022-03-29 Medos International Sarl Biceps tenodesis implants and delivery tools
US10709488B2 (en) 2014-10-23 2020-07-14 Medos International Sárl Biceps tenodesis delivery tools
US10729419B2 (en) 2014-10-23 2020-08-04 Medos International Sarl Biceps tenodesis implants and delivery tools
US10751161B2 (en) 2014-10-23 2020-08-25 Medos International Sárl Biceps tenodesis anchor implants
EP3888593A1 (fr) * 2014-10-23 2021-10-06 DePuy Synthes Products, Inc. Outils d'administration d'une ténodèse sur un biceps
US10856966B2 (en) 2014-10-23 2020-12-08 Medos International Sarl Biceps tenodesis implants and delivery tools
US9693856B2 (en) 2015-04-22 2017-07-04 DePuy Synthes Products, LLC Biceps repair device
US10758337B2 (en) 2015-04-22 2020-09-01 Medos International Sarl Biceps repair device
US11672647B2 (en) 2015-04-22 2023-06-13 Medos International Sarl Biceps repair device
CN105055048A (zh) * 2015-09-19 2015-11-18 施晓明 交叉韧带重建术滑翔伞状固定板装置
US11065104B2 (en) 2016-04-08 2021-07-20 Medos International Sarl Tenodesis anchoring systems and tools
US11071621B2 (en) 2016-04-08 2021-07-27 Medos International Sarl Tenodesis implants and tools
US10231823B2 (en) 2016-04-08 2019-03-19 Medos International Sarl Tenodesis implants and tools
US10231824B2 (en) 2016-04-08 2019-03-19 Medos International Sárl Tenodesis anchoring systems and tools
US11793624B2 (en) 2016-04-08 2023-10-24 Medos International Sarl Tenodesis implants and tools

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