Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
  • A61B17/025—Joint distractors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
  • A61B17/025—Joint distractors
  • A61B2017/0268—Joint distractors for the knee
• • 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
  • A61F2/30—Joints
  • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
  • A61F2/4657—Measuring instruments used for implanting artificial joints
  • A61F2002/4658—Measuring instruments used for implanting artificial joints for measuring dimensions, e.g. length

Definitions

• the present invention relates to a device for dynamic tensioning of a knee joint, also called a knee distraction device.
• a knee distraction device In the field of knee arthroplasty, the surgeon seeks to replace the natural knee joint, damaged or deficient, with a prosthetic joint which reproduces as faithfully as possible the kinematic capacities of the natural joints, while forming a stable structure, durable and painless.
• the soft parts (capsule, ligaments and tendons) of the knee joint play a considerable role in the mechanical strength of the joint when the latter is driven in motion. However, these soft parts are specific to each patient and can be more or less altered, for example due to diseases.
• the surgeon is often required to excise some of these ligaments, creating a new biomechanical environment.
• the objective sought is to obtain equal tensions of the soft parts of the knee at 0 and 90 ° of flexion and which are maintained over the entire flexion arc of the prosthesis, a satisfactory geometric alignment and a extension without flexum, to optimize the constraints when standing and obtain the best possible fit with the patient's anatomy.
• An objective important is to obtain good knee stability by appropriate ligament balancing.
• a device for tensioning the soft parts is generally used, commonly called a “tensor”, which generally comprises a femoral insert having two condylar bearing surfaces for the femur, a tibial insert having at least one support of the tibial plateau, and means of application between the femoral and tibial inserts of a distraction force of predetermined intensity.
• this tensor Associated with this tensor are known means for measuring the relative positions of the femur and the tibia, so that, by introducing the tensor into the space between the tibial end and the femoral articular end, it is possible to determine, under the chosen tension value imposed by the tensor, the gap between the tibia and the femur, as well as the angle HKA, that is to say the angle, taken internally, between the mechanical femoral axis (defined by the center of the hip and the center of the knee) and the tibial mechanical axis (defined by the center of the knee and the center of the ankle), on the one hand for the extension, and on the other hand, in bending at 90 °.
• the surgeon proceeds to the choice of the constituent elements of the prosthesis best suited, in particular in the set of elements at his disposal.
• the use of such tensors does not always ensure an optimal choice and / or positioning of the selected prosthetic elements, which does not allow optimal biomechanics to be obtained, in particular during the retraction of the posterior soft parts of the knee in flexum, and in the intermediate bending phases between 0 and 90 °, as well as beyond 100 °.
• the optimal biomechanics corresponds to a “good tension” of the soft parts in all the sectors of movement, namely tension of stability for the support and micro clearance zones of frontal and rotary laxity between 20 and 140 °, allowing easy mobility without ever hypertension or uneven or exaggerated laxity.
• the object of the present invention is to provide a tensioning device which overcomes the drawbacks mentioned above, by allowing continuous control, that is to say over substantially the entire bending stroke of the joint of the knee, the "good tension" of the soft parts.
• the subject of the invention is a device for dynamic tensioning of a natural or prosthetic knee joint, of the type comprising a device for tensioning a natural or prosthetic knee joint, tibial cut performed or no, of the type comprising at least one femoral insert which has a condylar support surface for a bone or a femoral implant; at least one tibial insert which has a bearing surface of a tibial tray for a tibial bone or implant; and means of application between the femoral and tibial inserts of a distraction force of predetermined intensity, ball joint in place or not, characterized in that it is arranged to allow rotation of the joint and includes means for keep the knee under tension during rotation, and thus carry out measurements for different angles of rotation.
• the condylar bearing surface is cup-shaped and is provided with sliding means for the bone or the femoral implant when the knee joint is displaced; the sliding means comprise juxtaposed rollers; - The sliding means comprise juxtaposed balls; - The condylar support surface is substantially cylindrical, with an axis substantially transverse to the direction of distraction; - the maximum thickness of each femoral and tibial insert is less than or equal to 2.5 mm; - a femoral insert, and possibly a tibial insert, are provided for each internal and external compartment of the knee joint; it includes means for measuring the spacing of the condylar support surfaces and of the support of the tibial plateau adapted to continuously measure the spacing between said support surfaces when the knee joint is moved; - It includes means for measuring the distraction force between the femoral and tibial inserts adapted to continuously measure the variation in the intensity of the distraction force around its predetermined intensity when the knee
• FIG. 1 is a perspective view of a tensioning device according to the invention
• Figure 2 is a section along the plane II-II shown in Figure 1
• - Figure 3 is a schematic front view of a natural knee joint inside which are placed the femoral and tibial inserts of the device of Figure 1, shown in section
• Figure 4 is a schematic side view corresponding to Figure 3.
• Figure 1 is shown a device 1 for tensioning a knee joint.
• This device 1 is essentially formed by two similar assemblies, namely an internal assembly 2A for the internal compartment of the joint at the level of the internal femoral condyle, and an external assembly 2B for the external compartment (at the level of the external femoral condyle).
• an internal assembly 2A for the internal compartment of the joint at the level of the internal femoral condyle
• an external assembly 2B for the external compartment (at the level of the external femoral condyle).
• the device will be described and oriented in relation to a standard knee joint, the terms upper or upper, lower or lower, anterior or front, and posterior or rear, as well as the terms internal and external, corresponding to those used to commonly describe such a joint.
• the internal 2A and external 2B assemblies comprise the same elements, only the elements of the internal assembly 2A will be described below, the corresponding elements of the external assembly 2B being referenced by the same number followed by the letter B.
• the external assembly 2A is in the general form of a clamp, and comprises two branches 4A articulated with respect to each other about a tilting axis 6A.
• the distal ends of the branches 4A are respectively provided with inserts (metallic or not), namely a femoral insert 8A intended to be placed in contact with a lower end portion of the femur, in particular the condyle, and a tibial insert 10A intended to be brought into contact with an upper end portion of the tibia.
• 1 femoral insert 8A has a general shape of cylinder segment of axis XX extending in a transverse direction. It comprises a series of juxtaposed rollers 12A, mounted for free rotation around axes 14A for example secured to a common plate 18A rigidly connected to the corresponding branch 4A.
• the axes 14A extend substantially parallel to the axis XX.
• the insert 8A thus provides a concave upper surface 20A, in the form of a bowl.
• This surface 20A is intended to form a support for the internal condyle of the femur, the radius of curvature of the cup 20A being chosen close to the mean radius of curvature of this internal condyle in the sagittal plane.
• the rollers can be replaced by a fixed bearing surface.
• the tibial insert 10A comprises, for its part, a plate 22A, of external dimensions substantially similar to those of the femoral insert 8A.
• the plate 22A extends in a direction substantially parallel to the axis XX of the femoral insert 8A.
• the tibial insert internally has a support surface 24A of an internal tibial plateau, that is to say of the natural upper internal surface of the upper end of the tibia opposite the internal condyle of the femur, or else 'a substantially flat surface formed in this end of the tibia, for example by means of a saw.
• the femoral inserts 8A, 8B and tibial 10A, 10B are not very thick, for example of the order of 2.5 mm each, so that they can be slid between the femur and the tibia, the patella advantageously not dislocated as shown in Figure 3, at each internal and external compartment of the knee joint before any cutting of the femur.
• the inserts can be removable with respect to the branches 4A and 4B and are fixed to these branches by means of quick fixing elements.
• the inserts are thus easily placed in the condylar compartments while they are not yet connected to the branches of the device.
• the proximal ends of the branches 4A of the internal assembly 2A are connected to each other by a unit 30A for generating a force tending to bring these ends together.
• the generation unit 30A comprises a piston 32A rigidly connected to one of the branches 4A, and a cylinder 34A rigidly connected to the other of the two branches 4A and inside which the piston 32A is movable.
• the upper end of the cylinder 34A is provided with a sealing screw 36A, delimiting with the internal walls of the cylinder and the head of the piston 32A, a chamber 38A of variable volume.
• a source of pressurized fluid provided with control means not shown, is connected to this chamber 38A, via a connector 40A provided with a pressure gauge 42A, and with regulation means 44A 46A.
• This motor function provided by this piston and this fluid can, as a variant, be provided by a controlled electric motor.
• the device 1 comprises means, not shown, for measuring the spacing of the bearing surfaces 20A, 20B, 24A and 24B.
• These means include for example a high definition digital camera associated with an infrared emission source covering the field in which a set of three markers evolves which passively return infrared radiation.
• This group of three markers is placed by the surgeon on one of the parts femoral or tibial of the joint, for example on the lower part of the femur, to form a three-dimensional marking system allowing the camera to conventionally determine the exact geometric location of one or more additional markers placed on a bone part mobile with respect to the reference system of the first three markers, for example placed on the tibia.
• the surgeon is able, by appropriate calculation means, to determine, with respect to the spatial reference system of the three markers placed on the femur, the exact position of the tibia, and in particular the angle of flexion between the two bones, the spacing between these bones, the lateral and antero-posterior displacements, and the relative rotations.
• the operation of the tensioning device is explained below, in the context of the establishment of a knee prosthetic joint.
• each implant conventionally comprising: a tibial component formed by a base cooperating with a tibial rod for the proper sealing of the base on a cutting surface of the tibial plateau, with for each type of base, a set of tibial plates, for example made of polyethylene, capable of being attached to the base to provide a tibial prosthetic articular surface; a femoral component comprising a distal end cooperating with a femoral rod intended for sealing in the femoral medular canal, with a prosthetic trochlear piece intended to be articulated with the tibial plateau, this trochlear piece being either directly integral with the distal femoral end , or, in other models, capable of being reported there for example with the interposition of shims from a set of shims of variable thicknesses; the tibial component and the femoral component being joined or not articulated by a pivoting
• the surgeon After having positioned the various infrared markers, as explained above, then proceeded to acquire the anatomical shapes of the relevant parts of the femur and the tibia and obtained the exact anatomical modeling of these shapes and dimensions by the abovementioned calculation means, the surgeon if necessary, resect the dilapidated tibial plateau and, using the mobile marker, mark the position of this cutting plane.
• the calculation means continuously supply the values of the current flexion and of the angle HKA. The surgeon then puts the knee in flexion, for example about 20 °, and inserts the tensioning device 1 inside the joint.
• the bearing surface 20A is then brought into contact, or at least opposite, the internal condyle of the femur, the bearing surface 20B is brought into contact, or at least opposite, the external condyle of the femur, and the bearing surfaces 24A and 24B are brought into contact with the natural tibial plateau or obtained after resection. More specifically, by way of example, for each condylar compartment, a first insert is put in place, then the second insert is then put in place after having dislocated the patella on the opposite side.
• the force generation units 30A and 30B are then actuated so as to tension the internal and external compartments of the knee. For each compartment, a predetermined force is imposed, controlled by the pressure gauges 42A and 42B.
• the infrared markers allow the surgeon to verify that the spacing between the femoral and tibial parts of the knee joint is satisfactory.
• the record simultaneous tensioning force and distance distance allows to better calculate the optimal tension of the soft parts.
• the tensioning device 1 While holding the tensioning device 1 in place, the surgeon brings the knee into different flexion positions and repeats these same measurements. Partly due to the concave shape and the sliding properties of the condylar support surfaces 20A and 20B, the device 1 is stabilized relative to the moving knee.
• the surgeon brings the knee for example around 0 ° of flexion, that is to say in extension. He then checks, continuously and intraoperatively, that, under the tension imposed by the bearing surfaces 20A, 20B, 24A and 24B, the relative spacing of the femoral and tibial parts is satisfactory.
• the dynamic study of the length, that is to say of the tension, of the soft parts of the joint during flexion and extension movements makes it possible to make the diagnosis of retraction of these soft parts , especially posterior, and therefore to guide the surgical gestures of release or tightening of these soft parts.
• the integration of dynamic data makes it possible on the one hand to determine the anatomical condylar centers of rotation.
• the device according to the invention makes it possible to determine the femoro-tibial prosthetic distances under a given pressure, during flexion-extension movements. In this way, the patient can have a guarantee of a correctly performed surgical act.
• tensioning device 1 uses other uses of the tensioning device 1 to study the pressure variations around the pressure value initially imposed, induced by the movements of the femoral and tibial parts of the joint; these “return” variations are for example measured by the pressure gauges 42A and 42B or the sensors connected to the slave motor; in this way, the surgeon continuously checks that the soft parts behave in the anatomically expected manner during the flexion of the joint; advantageously, these measured values are transmitted to the abovementioned calculation means which determine the exact values of the tensions imposed by the soft parts; and - at the start, in short or at the end of the intervention, each set 2A and 2B can be used independently, so as to determine the dynamic behavior of each articular compartment; in this way, if the differences in behavior of the compartments deviate from the expected anatomical tolerances, the surgeon makes adjustments to release or tighten the corresponding internal or external ligament parts.
• the sliding rollers 12A and 12B can be replaced by a series of juxtaposed balls mounted for free rotation or else a smooth surface with a low coefficient of friction, to allow the condylar surface to slide; each force generation unit 30A and 30B can be replaced by a motor controlled by a given and adjustable force allowing either to generate a constant given force, or, in the event of a "return" measurement of the pressures applied by the femoral parts and tibial, to measure corresponding forces, or else by a fitting formed of metal with shape memory; - the two tibial inserts 10A and 10B can be rigidly connected to one another so as to form a single tibial insert, the femoral inserts then being each articulated with respect to this single tibial insert, or else possibly rigidly connected to the one to the other; and / or - each pair of articulated branches 4A, 4B can be replaced by two arms substantially parallel to each other
• the device according to the invention can also be used as a tensor for the fe oropatellar joint, the femoral insert being applied against the trochlear surface and the tibial insert against the internal face of the patella. It is also possible to adapt the dimensions and shapes of the inserts for this purpose, in particular by giving the femoral insert a convex shape complementary to the surface of the trochlea, or else having sets of inserts which can be mounted and dismounted on the arms of the tensor.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Surgical Instruments (AREA)

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• 2003
  • 2003-08-05 FR FR0309655A patent/FR2858547B1/fr not_active Expired - Fee Related
• 2004
  • 2004-07-29 US US10/566,577 patent/US20060241640A1/en not_active Abandoned
  • 2004-07-29 WO PCT/FR2004/002046 patent/WO2005018509A2/fr active Application Filing
  • 2004-07-29 JP JP2006522369A patent/JP2007501039A/ja active Pending
  • 2004-07-29 EP EP04767820A patent/EP1651152A2/fr not_active Withdrawn
  • 2004-07-29 AU AU2004266089A patent/AU2004266089B2/en not_active Ceased

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