WO2014159561A1 - Dispositifs actifs et passifs pour redistribuer des forces pour les parties médiane et latérale du genou - Google Patents

Dispositifs actifs et passifs pour redistribuer des forces pour les parties médiane et latérale du genou Download PDF

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Publication number
WO2014159561A1
WO2014159561A1 PCT/US2014/024195 US2014024195W WO2014159561A1 WO 2014159561 A1 WO2014159561 A1 WO 2014159561A1 US 2014024195 W US2014024195 W US 2014024195W WO 2014159561 A1 WO2014159561 A1 WO 2014159561A1
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WO
WIPO (PCT)
Prior art keywords
implant
knee joint
tendon
knee
tension
Prior art date
Application number
PCT/US2014/024195
Other languages
English (en)
Inventor
Anton G. Clifford
Andrew H. JONES
Original Assignee
Moximed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/894,261 external-priority patent/US9486319B2/en
Priority claimed from US13/894,267 external-priority patent/US9308094B2/en
Application filed by Moximed, Inc. filed Critical Moximed, Inc.
Priority to EP14775513.6A priority Critical patent/EP2967890A4/fr
Publication of WO2014159561A1 publication Critical patent/WO2014159561A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • 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
    • A61B2017/564—Methods for bone or joint treatment
    • 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
    • A61B2017/567—Joint mechanisms or joint supports in addition to the natural joints and outside the joint gaps
    • 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
    • A61F2/38—Joints for elbows or knees

Definitions

  • the present disclosure is directed towards systems and methods for treating tissue of a body and more particularly, towards approaches designed to treat a natural joint and conditions involving the knee joint specifically.
  • a joint is the location at which two or more bones make contact. They are constructed to allow movement and provide mechanical support, and are classified structurally and functionally. Structural classification is determined by how the bones are connected to each other, while functional classification is determined by the degree of movement between the articulating bones. In practice, there is significant overlap between the two types of
  • Fibrous/Immovable joints are connected by dense connective tissue, consisting mainly of collagen.
  • the fibrous joints are further divided into three types: sutures which are found between bones of the skull; syndesmosis which are found between long bones of the body; and gomphosis which is a joint between the root of a tooth and the sockets in the maxilla or mandible.
  • cartilage also known as cartilage
  • Bones Cartilaginous joints allow more movement between bones than a fibrous joint but less than the highly mobile synovial joint.
  • Synovial joints have a space between the articulating bones for synovial fluid.
  • This classification contains joints that are the most mobile of the three, and includes the knee and shoulder. These are further classified into ball and socket joints, condyloid joints, saddle joints, hinge joints, pivot joints, and gliding joints. [0005] Joints can also be classified functionally, by the degree of mobility they allow.
  • Synarthrosis joints permit little or no mobility. They can be categorized by how the two bones are joined together. That is, synchrondoses are joints where the two bones are connected by a piece of cartilage. Synostoses are where two bones that are initially separated eventually fuse together as a child approaches adulthood. By contrast, amphiarthrosis joints permit slight mobility. The two bone surfaces at the joint are both covered in hyaline cartilage and joined by strands of fibrocartilage. Most amphiarthrosis joints are cartilaginous.
  • diarthrosis joints permit a variety of movements (e.g. flexion, adduction, pronation).
  • diarthrodial joints are diarthrodial and they can be divided into six classes: 1. ball and socket - such as the shoulder or the hip and femur; 2. Hinge - such as the elbow; 3. Pivot - such as the radius and ulna; 4. condyloidal (or ellipsoidal) - such as the wrist between radius and carps, or knee; 5. Saddle - such as the joint between carpal thumbs and metacarpals; and 6. Gliding - such as between the carpals.
  • Synovial joints are the most common and most moveable type of joints in the body. As with all other joints in the body, synovial joints achieve movement at the point of contact of the articulating bones. Structural and functional differences distinguish the synovial joints from the two other types of joints in the body, with the main structural difference being the existence of a cavity between the articulating bones and the occupation of a fluid in that cavity which aids movement.
  • the whole of a diarthrosis is contained by a ligamentous sac, the joint capsule or articular capsule.
  • the surfaces of the two bones at the joint are covered in cartilage. The thickness of the cartilage varies with each joint, and sometimes may be of uneven thickness.
  • Articular cartilage is multi-layered.
  • a thin superficial layer provides a smooth surface for the two bones to slide against each other. Of all the layers, it has the highest concentration of collagen and the lowest concentration of proteoglycans, making it very resistant to shear stresses. Deeper than that is an intermediate layer, which is
  • the synovium is a membrane that covers all the non-cartilaginous surfaces within the joint capsule. It secretes synovial fluid into the joint, which nourishes and lubricates the articular cartilage. The synovium is separated from the capsule by a layer of cellular tissue that contains blood vessels and nerves.
  • Arthritis is a group of conditions where there is damage caused to the joints of the body. Arthritis is the leading cause of disability in people over the age of 65.
  • Rheumatoid arthritis and psoriatic arthritis are autoimmune diseases in which the body is attacking itself. Septic arthritis is caused by joint infection. Gouty arthritis is caused by deposition of uric acid crystals in the joint that results in subsequent inflammation. The most common form of arthritis, osteoarthritis is also known as degenerative joint disease and occurs following trauma to the joint, following an infection of the joint or simply as a result of aging.
  • the tendon of popliteus also runs between the femur and lower leg and includes a length along the lateral side of the knee as well as a portion which wraps about the back of the knee and connects to the popliteus muscle.
  • the medical (tibial) collateral ligament extends across the knee on a medial side of the joint, as does the arcuate ligament.
  • the patellar ligament In the front of the knee, there is the quadriceps tendon above and connected to the kneecap and below and extending from the kneecap is the patellar ligament.
  • the anterior cruciate ligament and posterior cruciate ligament Within the knee, there are the anterior cruciate ligament and posterior cruciate ligament.
  • the knee anatomy includes the articular capsule which contains the patella, ligaments, menisci and bursai. Each of such structures can be misaligned or affected by disease causing unnatural gait or individual specific problems.
  • the knee joint is capable of flexion and extension motions and can undergo slight rotational movement. It is this rotational component that accounts for the frequency of knee injuries.
  • tissue injury can manifest as swelling about the knee, inability to bear weight or loss of function. Fractures that enter the knee joint often render the joint defective and the once smooth joint surface made irregular. Additionally, fractures resulting in improper limb alignment may contribute to long-term morbidity like arthritis, instability, and functional loss of motion.
  • the stabilizing ligaments of the knee include the medial collateral ligament (MCL) and lateral collateral ligament (LCL), and are located outside the knee joint proper.
  • MCL medial collateral ligament
  • LCL lateral collateral ligament
  • the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) are stabilizer ligaments located within the knee joint.
  • the patellar ligament is located outside the knee joint and functions to provide support for the knee by shielding it, and strengthening the actions of the quadriceps femoris muscle.
  • the collateral ligaments resist widening of the knee joint.
  • the cruciate ligaments which are within the knee joint proper resist hyperflexion and hyper extension and also slight rotational movements of the knee.
  • Articular cartilage is bathed by synovial fluid that lubricates the knee joint.
  • joints can suffer from specific patterns of disease.
  • lateral osteoarthritis of a joint such as the knee is characterized by a disease pattern tending to be a flexion based disease.
  • the lateral knee has a more complex anatomy than the medial knee and has associated therewith a number of unique neighboring musculoskeletal, vascular and neurological structures, which thereby limit implant real estate.
  • the motion of the lateral knee is also much broader than the medial knee.
  • Such particular patterns of disease can thus necessitate highly specific treatment approaches.
  • the present disclosure is directed towards treating joint structures.
  • approaches to redistributing forces of the joint to alleviate pain or to address misalignment are disclosed.
  • an implant which is contoured to receive a tendon of the knee.
  • the contour of the implant is configured to define structure preventing the tendon from disengaging from the implant during a full range of motion of a knee joint.
  • the implant is also contoured to avoid negative remodeling of the tissue of the knee.
  • the implant can embody a fluid filled bladder which self-contours to tissues.
  • the implant can be adjustable through the movement, addition or removal of fluid.
  • Various embodiments are contemplated to treat knee joint misalignment and to inhibit dislocation, as well as to absorb unnatural loads applied by the bones of the joint upon adjacent anatomy.
  • an implant can include a two stage bladder having a main chamber for positioning under a ligament and a secondary chamber in communication with the main chamber.
  • a valve can further be provided between the main and secondary chambers.
  • An implant can include a chamber that is fluid or gas filled to provide a compliant bolster and lengthening effect to increase a moment arm of the bolstered tendon or muscle.
  • the chamber and bladder can be inflated or expanded over time to provide an increasing size or stiffness structure, or deflated or contracted to provide an opposite effect.
  • a valve or injection port can be utilized for this functionality.
  • the implant can further be configured such that when a leg is in extension, there is no force or little force in a first chamber of the implant. An elasticity of a second chamber is selected to cause fluid to flow into the first chamber.
  • a valve between the chambers retains fluid within the first chamber. When at rest, with the joint in flexion the tendon presses fluid from the first chamber into the second chamber.
  • an implant is provided to treat a joint and functions to redistribute forces of a knee joint.
  • the implant includes structure accomplishing attachment of the implant to the target tendon.
  • This implant can be a single spacer or can include one or more chambers that contain fluid or gas. Such an implant thus remains in place during a full range of motion of a knee joint.
  • An active unloading device assembly can be employed to unload a lateral knee compartment by implanting the assembly on a medial side of the joint.
  • the assembly is configured to impart varizing load to the joint and to unload the lateral compartment.
  • the assembly can include an extendable tension loop which applies the desired varizing force.
  • the active unloading assembly includes a first base configured to be affixed to a first bone of a joint and a second base configured to be affixed to a second bone of a joint.
  • each base can be a projection about which a collar can be coupled in an articulating arrangement.
  • a piston can be further provided between the collars.
  • the extendable tension loop is configured about the collars and across a joint to provide the desired varizing load.
  • FIGS. 1A-D are various views, depicting the anatomy of a knee joint
  • FIG. 2 is a perspective view, depicting an implant attached to members defining a joint
  • FIG. 3 is a cross-sectional view, depicting the structure of FIG. 2 taken along line 3-3;
  • FIG. 4 is a perspective view, depicting the implant of FIG. 2;
  • FIGS. 4A and 4B are perspective views of alternative shaped implants attached to a member of a joint
  • FIG. 5 is a perspective view, depicting another embodiment of an implant attached to members defining a joint
  • FIG. 6 is a cross-sectional view, depicting the structure of FIG. 5 taken along lines 6- 6;
  • FIG. 7 is yet another perspective view, depicting another embodiment of an implant attached to members defining a joint
  • FIG. 8 is a cross-sectional view, depicting the structure of FIG. 7 taken along lines 8- 8;
  • FIG. 9 is a perspective view, depicting another embodiment of an implant
  • FIGS. 10 and 11 are perspective views, depicting the implant of FIG. 9;
  • FIG. 12 is a side view, depicting yet another embodiment of an implant placed at a joint;
  • FIG. 13 is a cross-sectional view, depicting excessive overload of a lateral compartment of a knee joint;
  • FIG. 14 is a graphical representation, depicting knee flexion angles for lateral and medial osteoarthritis patients
  • FIG. 15 is a graphical representation, depicting kinetic patterns of a knee joint
  • FIG. 16 is a top view, depicting one approach to an active unloading assembly
  • FIGS. 17A-B are cross sectional views, depicting the assembly of FIG. 16 attached across a joint.
  • FIG. 18 is a cross-sectional view, depicting forces on a joint treated with the active unloading assembly.
  • the present disclosure is directed towards apparatus and methods for treating the knee joint.
  • Misalignment or dislocation can be due to natural anatomy specific to an individual or can be a function of a disease or condition, such as arthritis.
  • Significant pain can be associated with these conditions and can be a direct result of excessive forces being generated between joint members.
  • pain results when there are undesirable force contacts between the tibia and the femur or through inadequate anatomy separating these bones.
  • the present disclosure is directed at both passive and active devices for alleviating pain by redirecting or absorbing excess forces without permanently remodeling tissues critical to the functioning of the knee joint.
  • one approach to treating conditions involving a knee can include the placement of a spacer or an implant 100 at the knee joint 102.
  • the implant 100 can be generally U-shaped and can include terminal ends 104 configured to be affixed to body anatomy.
  • the terminal ends 104 include through holes 106 sized and shaped to receive bone screws 108 or other affixation structure.
  • the implant 100 can be attached directly to a femur 110, tibia 112 or fibula 114 of the knee joint 102.
  • the implants have been described herein as attached to a bone surface beneath a tendon, the implants can also reside beneath other anatomical structures including ligaments and muscles or a combination of anatomical structures.
  • the implant can function to apply a tensioning force to all of the surrounding structures in combination (i.e. displacing both tendon and muscle tissue) to adjust alignment of the joint and redirect forces transmitted through the joint.
  • the implant 100 is affixed to the tibia 112 such that a midsection 120 of the implant 100 is configured under a ligament or tendon 130.
  • the implant is shown positioned under the fibular collateral ligament, but it is to be appreciated that the implant can be arranged under any knee structure so long as the desired redistribution of forces is accomplished.
  • the terminal ends 104 of the implant 100 are shown directed away from the knee joint 102 but can alternatively be pointing toward the knee joint 102.
  • the implant 100 is further contoured to define a anatomically matching structure. It is thus contemplated that a lower surface 140 of the implant 100 be curved to mimic the shape of the structure to which the implant engages, such as the tibia 112 or femur 110.
  • An upper surface 142 is also contoured so as to fit nicely with the knee anatomy and may include a lubricious coating or material permitting relative motion between the implant and knee anatomy.
  • the upper surface 142 further includes a recess 144 designed to receive the tendon 130.
  • the recess 144 defines a trough through which the tendon 130 can be translated throughout a full range of articulation and valgus and varus motion or other rotation or movement of the knee joint.
  • a portion of the tendon 130 remains within the recess 144 throughout gait as well as when the knee joint is in complete flexion or extension, and all angles therebetween, and when the knee joint is loaded and unloaded.
  • the trough 144 may be used to prevent the tendon from slipping off of the implant in the anterior or posterior directions.
  • the implant 100 can be configured to include one or more structure that only applies tension during gait, and then, during only portions of the gait cycle.
  • Such structure can also include a load absorption component acting during such intervals.
  • FIGS. 4A and 4B illustrate an implant 170 having an I-shape and an implant 180 having an L-shape.
  • FIGS. 5 and 6 there is shown another embodiment of a spacer or an implant 200.
  • the implant can be generally U-shaped and includes terminal ends 204 configured to be affixed to body anatomy. Again, through holes 206 are provided to receive affixation structure such as bone screws 108 so that the implant can be attached directly to knee anatomy.
  • An upper surface 242 of the implant 200 is intended to be lubricous to permit relative movement with a tendon 130.
  • the implant can be configured with its terminal ends 204 directed toward or away from the knee joint 102 and can include a midsection 220 with a recess 244 shaped to receive the tendon 130 through a full range of motion of the knee.
  • This embodiment of the implant further includes a fluid, gas or gel filled chamber or bladder 250 which is accessible by an injection port 252.
  • the chamber 250 can form an integral structure with remaining portions of the implant 200 and portions of the implant 200 can embody fiber woven reinforced fixation material to form a single bodied structure.
  • the injection port 252 is employed to both place substances within the chamber 200 and to be accessible to alter the volume or composition of the substance before and after implantation.
  • the port can also be used to remove all or most fluid when implanting or removing the device or to alter the softness or rigidity of the implant.
  • the structure defining the chamber 250 can have an elasticity greater than that chosen for the remaining portions of the implant 200, such as for example the terminal ends 204 which are designed to have a rigidity or robustness suited for permanent attachment to knee anatomy.
  • the materials are of course chosen to be biocompatible in any event.
  • the substance chosen to fill the chamber 250 is selected to cooperate with the material chosen for walls defining the chamber 250 so that desired tensioning and load absorption can be effectuated. It is further contemplated to take advantage of fluid responses of the substances chosen for placement within the chamber 250.
  • a viscous fluid or gel such as silicone hydrogel flows smoothly under low strain rates, but resists flow under high strain rates. Therefore, the fluid or gas chosen is intended to have a viscosity and the chamber walls are designed to have a flexibility to transmit tension along the tendons and to absorb excess forces so as to alleviate pain.
  • tension and load manipulation can be reserved to occur only during gait, and for that matter, during only portions of gait. During rest, or otherwise when there is no pain due to forces associated with the this manipulation is removed so that undesirable remodeling is avoided.
  • the tension transferring and load absorbing chamber 250 is sized and shaped to span the recess 244 so that during certain portions of gait, tension is transferred along the tendon 130 and forces generated through the tendon 130 are absorbed in a manner to relieve pain associated with the unnatural engagement of knee anatomy.
  • forces between the tibia 104 and the femur 102 can be alleviated and angles with which these bones are moved relative to adjacent anatomy can be altered to thereby minimize pain.
  • the implant 300 can further include multiple chambers 350, 352 that are in fluid communication and which are versatile in accommodating tension and contact forces.
  • the generally U-shaped device can be extended to provide a platform about each of the chambers 350, 352.
  • the chambers 350, 352 are designed to receive gases or fluids which embody desirable viscosity characteristics.
  • the first chamber 350 is intended to be arranged to be in apposition with the tendon 130 and the second chamber 352 is to be positioned remote from the tendon 130.
  • the walls defining the chambers 350, 352 are formed from materials having an elasticity designed to achieve desired tension and contact force manipulation throughout the full range of motion of the knee joint.
  • An injection port 354 is additionally included to provide access to the second chamber 352 so that the volume or composition of the substance in the chamber can be altered.
  • a neck 356 joining the first 350 and second 352 chambers provides the fluid communication between the structures.
  • a valve (not shown) can be configured in this area or the neck can define a small opening.
  • the neck 356 can be configured to play a role in the movement of fluid from one chamber to the next. For example, when a leg of an individual is in extension, there is no force or little force on the first chamber 350. The elasticity of the second chamber 352 is chosen to thus cause fluid to flow into the first chamber 350.
  • the sizing of the neck 356 is such that its flow access is limited so that there is insufficient time for fluid to pass from the first chamber 350 to the second chamber 352. Rather, the fluid remains but flows within the first chamber 350 to thereby provide tension and contact force manipulation and absorption.
  • the force of the tendon 130 presses fluid out of the first chamber 350 into the second chamber 352.
  • the first chamber 350 is reduced in size during this juncture, and the tendon is not subjected to tension and force manipulation. By not engaging in this manipulation, the tendon 130 can be unloaded and remodeling thereof is avoided.
  • This implant 400 can further include one or more of the features described above including one or more fluid filled chambers. Further, it is again contemplated that the device be formed from biocompatible materials.
  • This particular implant 400 further embodies a porous or mesh tendon contacting surface 402 and a lubricious bearing surface 404.
  • the porous mesh surface 402 supports ligament ingrowth and aids in attachment to the tendon 130.
  • the lubricious bearing surface 404 slides along knee anatomy during articulation.
  • Through holes 400 are further provided and sized and shaped to receive fastening structure 410 for assuring a strong affixation to the tendon 130. In this way, relative movement between the implant 400 and ligament is eliminated and the implant 400 is thus always correctly positioned to provide desired tensioning and contact force load manipulation and absorption.
  • an implant 500 can include one or more of the above described features, such as one or more chambers, and further embodies a generally inverted J-shape.
  • a vertically extending portion 502 of the implant 500 is provided with through holes sized and shaped to receive fastening structure such as bone screws 108.
  • a laterally extending portion 508 includes a recess 510 for receiving a tendon 130.
  • the implant 500 is shown attached to the tibia 112, it can also be affixed to the femur 110 or fibula 114 as well. This approach illustrates that an asymmetric implant can be employed to accomplish desired treatment of the knee joint. A further deviation would be to eliminate the vertically extending portion 502 and to include affixation structure within the recess 510.
  • the J-shaped implant 500 can also function as a hook to change the path of the tendon.
  • the implants described herein are designed to displace a tendon or other anatomical, joint spanning structure in a direction away from the joint to increase the tension in the tendon or other structure.
  • the increased tension causes load to be transferred within the joint structure.
  • an laterally placed implant increases the tension in the lateral ligaments and shifts a portion of the load in the knee joint from the medial surfaces to the lateral surfaces of the joint.
  • the displacement of the tendon is shown as generally in a direction away from the joint, other displacement of the tendon can also function to increase tension and redistribute forces in the joint.
  • a J-shaped or hook shaped implant can displace a portion of a ligament in an anterior or posterior direction causing the ligament to travel along a longer trajectory than the natural trajectory increasing tension in the ligament.
  • the foregoing therefore provides an implant embodying a compliant bolster and lengthening affect to increase a moment arm of the bolstered tendon for the purpose of relieving pain or other symptoms involving the knee.
  • the size or stiffness of the implant can be altered to achieve the desired bolstering or manipulation of tension and contact forces.
  • for positioning an implant on the medial or lateral side of the knee joint having a height selected to increase tension in the tendon by at least 5 pounds can provide opening of the joint space on the opposite side of the knee joint an associated pain relief.
  • the anatomy of the lateral side of the knee joint is complicated as compared with the medial side.
  • real estate for an implant is limited on the lateral side of the knee joint 102.
  • osteoarthritis can of course affect either side of a knee joint.
  • FIG. 13 there can exist for example, an excessive overload of a lateral compartment of a knee.
  • the larger arrows indicate greater forces in a joint on a lateral side 600 of a joint 102 as compared with the medial side 602.
  • One treatment modality is to unload the lateral compartment by moving load onto the medial compartment using an implant attached to the medial knee.
  • the implant is contemplated to actively import a varizing load to the knee and to unload the lateral compartment.
  • OA can be identified to be mainly in the anterior, mid, or posterior portion of the lateral compartment
  • treatment can be tailored to unload at the appropriate flexion angle. For example, unloading at 1- 10 degrees for anterior OA, unloading at 35-45 degrees for mid lateral compartment OA, and unloading at 60-80 degrees for posterior OA.
  • the implant is preferably designed to tension the medial ligaments and/or tendons over at least 50 degrees of motion and more preferably over at least 70 degrees of motion.
  • the motions of the lateral knee are much broader than that of the medial knee. That is, the spacing within the medial capsule between the femur and tibia falls within a relatively narrow height, ranging around 24 mm to 25 mm, whereas the spacing within the tibial capsule decreases from 24 mm at 0° flexion to 13 mm at 90° flexion.
  • the kinematic requirements for implants utilizing lateral attachment points necessarily increases. Accordingly, both the lack of real estate and the greater range of movement on the lateral side of the knee joint suggest implanting a device for treating lateral osteoarthritis on the medial side.
  • an active unloading assembly 610 is contemplated to be configured across a knee joint (See FIGS. 16-17B).
  • the active component of the assembly 610 is a tension assembly 612 configured to apply a varizing tension force to unload the lateral component.
  • the tension assembly 612 and remaining portions of the active unloading assembly 610 are affixed to a medial side of a knee joint 102 to thereby create the desired tension force for unloading the lateral compartment.
  • the devices can be attached on other joints and at various angles and various sides of joints to create other desired effects.
  • the active unloading assembly 610 can further include a first base assembly 614 for attachment to a femur 110, as well as a second base assembly 616 for attachment to a tibia 112 (FIGS. 17A-B). Extending from each base 614, 616 can be a projection 620 configured to receive opposite ends of the tensioning assembly 612. The projections 620 are configured to provide an articulating connection between the bases 614, 616 and the tensioning assembly 612.
  • the tension assembly 612 includes a tension loop 622 configured about a pair of spaced collars 624.
  • the collars 624 are each sized and shaped to receive one base projection 620 and to provide an articulating structure.
  • the collars 624 as shown connected to the bases in an articulating manner by projections, other methods of connecting the collars to the bases in an articulating manner may also be employed, such as ball and socket joints.
  • the collars may be formed integrally with the bases and the articulation may be omitted in which case the flexibility required by the system would be provided by the tension loop alone.
  • the articulating structure accommodates the motion of the members of a joint 102 during flexion and extension.
  • a telescoping piston assembly 630 can be configured between the collars 624, the same helping to ensure the integrity and stability of the system. As the joint members transition between flexion and extension, the member of the piston assembly 630 slide with respect to each other. In some situations where the added stability is not needed, the telescoping assembly can be omitted.
  • the tension loop 622 as shown in the present application is a biocompatible elastomeric band having a circular cross section.
  • other types of tension bands, cables or springs may also be used.
  • the active loading assembly is implanted on a medial side, and across a knee joint.
  • the tension assembly 612 operates to apply a varizing force to the lateral compartment during the natural motion of the knee, so as to off-load the lateral compartment to address an osteoarthritic condition. It is further contemplated that the tension can be applied during less than a full cycle of limb articulation or throughout an entire flexion- extension cycle. It is also contemplated that a contact or variable tension force is provided by the assembly.
  • FIG. 18 there is shown the forces on a joint after treatment with the active unloading assembly. As shown, the forces on the lateral side 600 of a knee joint, as compared with those previously existing in an untreated joint shown in FIG. 13 are decreased, and forces are generally balanced across the joint. Pain associated with undisclosed forces associated with lateral osteoarthritis is thus remedied.

Abstract

La présente invention concerne un appareil et des méthodes pour implants destinés à traiter des états impliquant l'articulation du genou. Toute la plage de mouvements de l'articulation du genou et l'intégrité du tissu sont conservés dans des approches de traitement. Selon une approche particulière, l'arthrose du genou est traitée en déchargeant un ou plusieurs des compartiments latéraux et médians.
PCT/US2014/024195 2013-03-14 2014-03-12 Dispositifs actifs et passifs pour redistribuer des forces pour les parties médiane et latérale du genou WO2014159561A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14775513.6A EP2967890A4 (fr) 2013-03-14 2014-03-12 Dispositifs actifs et passifs pour redistribuer des forces pour les parties médiane et latérale du genou

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201361784774P 2013-03-14 2013-03-14
US61/784,774 2013-03-14
US13/894,261 US9486319B2 (en) 2012-05-14 2013-05-14 Load transferring systems
US13/894,261 2013-05-14
US13/894,267 2013-05-14
US13/894,267 US9308094B2 (en) 2012-05-14 2013-05-14 Active and passive devices for redistributing forces for the medial and lateral knee

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US5171276A (en) * 1990-01-08 1992-12-15 Caspari Richard B Knee joint prosthesis
US6629997B2 (en) * 2000-03-27 2003-10-07 Kevin A. Mansmann Meniscus-type implant with hydrogel surface reinforced by three-dimensional mesh
US20100114322A1 (en) * 2007-05-01 2010-05-06 Moximed, Inc. Extra-Articular Implantable Mechanical Energy Absorbing Systems and Implantation Method
KR20120068827A (ko) * 2009-07-10 2012-06-27 미룩스 홀딩 에스.에이. 이식가능한 윤활 장치
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