WO2024010989A1 - Prothèse articulaire implantable avec systèmes de sollicitation intégrés - Google Patents

Prothèse articulaire implantable avec systèmes de sollicitation intégrés Download PDF

Info

Publication number
WO2024010989A1
WO2024010989A1 PCT/US2023/064497 US2023064497W WO2024010989A1 WO 2024010989 A1 WO2024010989 A1 WO 2024010989A1 US 2023064497 W US2023064497 W US 2023064497W WO 2024010989 A1 WO2024010989 A1 WO 2024010989A1
Authority
WO
WIPO (PCT)
Prior art keywords
joint
prosthesis
component
prosthetic
biasing
Prior art date
Application number
PCT/US2023/064497
Other languages
English (en)
Inventor
Gregory W. Stocks
Mark R. Brinker
Original Assignee
Extensor, LLC
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
Application filed by Extensor, LLC filed Critical Extensor, LLC
Publication of WO2024010989A1 publication Critical patent/WO2024010989A1/fr

Links

Classifications

    • 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
    • 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
    • A61F2/32—Joints for the hip
    • 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
    • A61F2/3804—Joints for elbows or knees for elbows
    • 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
    • A61F2/3836—Special connection between upper and lower leg, e.g. constrained
    • A61F2/384—Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement
    • 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
    • A61F2/40—Joints for shoulders
    • 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
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • 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
    • A61F2/48—Operating or control means, e.g. from outside the body, control of sphincters
    • A61F2/482—Electrical means
    • 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
    • A61F2/48—Operating or control means, e.g. from outside the body, control of sphincters
    • A61F2/484—Fluid means, i.e. hydraulic or pneumatic
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30079—Properties of materials and coating materials magnetic
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30505—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism spring biased

Definitions

  • inventions disclosed and described herein relate to an implantable joint prosthesis for patients with compromised or nonexisting joint muscle systems, such as extensor, abductor, adductor, or other joint muscle systems.
  • the present inventions are directed to improvements in implantable total joint prostheses for use with patients with compromised or non-existent joint musculature systems.
  • FIG. 1 illustrates a typical human knee.
  • FIG. 2 illustrates the extensor mechanism of a typical human knee.
  • FIG. 3 illustrates an in situ total knee prosthesis having an integrated prosthetic extensor mechanism for persons with compromised extensor mechanisms.
  • FIG. 4 illustrates an in situ intermedullary knee prosthesis having an integral extensor mechanism for persons with compromised extensor systems.
  • FIG. 5 illustrates another embodiment of an in situ total knee prosthesis having an integrated extensor mechanism for persons with compromised extensor systems.
  • FIG. 6A illustrates an embodiment of a smart prosthetic knee and associated technology.
  • FIG. 6B illustrates an embodiment of a control system for smart prosthesis.
  • FIG. 7 illustrates a logic flow chart for a top-level algorithm for software useful with embodiments of the present inventions.
  • FIG. 8 illustrates an embodiment of a rotation mechanism for an in situ total knee prosthesis having an integrated extensor mechanism for persons with compromised knee extensor systems.
  • FIG. 9 illustrates another embodiment of an in situ total knee prosthesis having an integrated extensor mechanism for persons with compromised extensor systems.
  • FIG. 10 illustrates an elbow prosthesis utilizing aspects of the disclosed inventions.
  • FIG. 11 illustrates possible embodiments of an implantable elbow joint prothesis utilizing aspects of the disclosed inventions.
  • FIG. 12 illustrates an implanted ankle prosthesis.
  • FIG. 13 illustrates an ankle prosthesis utilizing aspects of the disclosed inventions.
  • FIG. 14A illustrates a shoulder prosthesis utilizing aspects of the disclosed inventions.
  • FIG. 14B illustrates a reverse shoulder prosthesis utilizing aspects of the disclosed inventions.
  • FIG. 15 illustrates a hip prosthesis utilizing aspects of the disclosed inventions.
  • embodiments may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects, such as a “circuit,” “module” or “system.”
  • embodiments of the present inventions may take the form of a computer program product embodied in one or more computer readable storage media having computer readable program code.
  • modules Items, components, functions, or structures in this disclosure may be described or labeled as a “module” or “modules.”
  • a module may be configured as a hardware circuit comprising custom VLSI circuits or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components.
  • a module also may be implemented as programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices, or the like.
  • Modules also may be configured as software for execution by several types of processors.
  • a module of executable code may comprise one or more physical or logical blocks of computer instructions that may be organized as an object, procedure, or function. The executables of a module need not be physically located together but may comprise disparate instructions stored in various locations that when joined logically together, comprise the module and achieve the stated purpose or function.
  • a module of executable code may be a single instruction, or many instructions, and may even be distributed over several different code segments, among different programs, and across several memory devices.
  • data may be identified and illustrated herein within modules, and may be embodied in any suitable form and organized within any suitable type of data structure.
  • the data may be collected as a single dataset or may be distributed over various locations including over different storage devices, and may exist, at least partially, merely as electronic signals on a system or network.
  • a module or portions of a module are implemented in software, the software portions may be stored on one or more computer readable storage media.
  • our inventions relate to implantable joint prostheses for individuals that have compromised or non-functional joint muscle systems.
  • the prostheses of the present inventions may comprise a modified conventional ex situ or external prosthetic knee joint with or without an integrated extensor mechanism configured to provide one or more biasing forces to the joint to simulate or approximate a level of normal knee function (e.g., extension).
  • the prostheses of the present inventions may comprise a modified conventional or unconventional implantable elbow joint prosthesis, ankle joint prothesis, shoulder prosthesis or hip joint prosthesis, with one or more integrated biasing systems structured to move or bias the joint to one or more preferred alignments or orientations.
  • the prostheses of the present inventions also may comprise an integrated braking mechanism (i.e., a system to retard, minimize or eliminate velocity and/or acceleration or both) configured to provide one or more constant or variable forces to the joint to simulate or approximate a level of human joint function.
  • Suitable biasing and/or braking mechanisms include, without limitation, spiral springs, wafer springs, hydraulic cylinders, pneumatic cylinders, magnets, camming surfaces, and linear motors.
  • Implantable joint biasing systems or components may comprise torsion springs integrated into one or more joint hinges. Alternately, biasing systems components may comprise hydraulic, pneumatic, magnetic, or mechanical systems. In yet another envisioned embodiment, combinations of these extension biasing components may be combined. As described, the neutral spring condition with increasing amount of return biasing force from increasing amounts of flexion or movement may be combined with, as a non-limiting example, a magnetic component that negates some of the return biasing force to provide a limited or dampened return swing.
  • the biasing components may comprise a brake that releasably “locks” the implantable joint in particular position or range of positions yet is overcome by the swing forces associated with a normal or active movement.
  • a preferred biasing system comprises an assembly of magnets or magnets and magnetic materials.
  • These biasing systems may comprising permanent magnets that attract each other, permanent magnets, such as ferromagnets, that repel each other, a combination of permanent magnets and paramagnetic material that attract one another; a combination of permanent magnets and diamagnetic material that repel one another; and combinations of permanent magnets, paramagnets, diamagnets, antiferromagnets and/or ferrimagnets alone or in combination with out biasing or braking systems to create a desired prosthetic joint operation. It will be appreciated that these systems can be configured to produce rotational attraction or repulsion as well as planar attraction or repulsion.
  • FIG. 10 illustrates a conventional, implantable elbow joint prothesis comprising an ulnar component, a humeral component, and a single axis rotation joint therebetween.
  • the prosthesis also comprises a humeral bearing pad, and two ulnar bearings.
  • the prosthesis of FIG. 10 comprises an integrated biasing system structurally configured to move, urge, or bias the relative alignment of the humeral and ulnar components to a desired condition or state.
  • One type of biasing system suitable for use with the prothesis illustrated in FIG. 10 comprises one or more magnets (e.g., permanent magnets) placed in the prosthesis components to attract the components to a desired condition or state, or to repel the components to or from a desired condition or state.
  • magnets e.g., permanent magnets
  • the elbow joint be biased to a particular angular position, such as 45, 60 or 90 degrees flexion, magnets may be implanted in the components in such positions that the components are attracted to this preferred alignment or repelled to this preferred alignment.
  • multiple magnetic biasing systems can be implemented, such as, for example, to bias the joint to full extension (0 degrees) and to 90 degrees by using two sets of magnets integrated into the prosthesis.
  • a magnetic biasing system may comprise one or more rods, buttons, pads, or other geometrically shaped permanent magnets that can be integrated into the non-magnetic alloy.
  • rod shaped magnets a hole corresponding to the size (e.g., diameter and length) of the magnetic rod can be drilled into the prosthetic component in the appropriate location or locations.
  • the magnetic rod can be placed, preferable by an interference fit, into the hole. If necessary, such for biocompatibility issues, the magnetic rod can be covered in the hole, such as by an interference fit cap or cover, threaded cap, or welded cap of biocompatible base material.
  • any geometrically shaped magnet may be integrated into a prosthetic joint component as described, including casting the magnet systems into the joint components.
  • Permanent magnet systems suitable for use with the prostheses disclosed herein may compromise Ferrite magnets, Alnico magnets, Permalloy magnets, Neodymium magnets, and Samarium Cobalt magnets.
  • the magnetic direction of the magnet(s) integrated into the prosthetic components can be configured to provide the desired amount and/or range of bias for the joint. For example, for an elbow prosthesis, aligning the magnetic directions between magnet(s) in the ulnar component and magnet(s) in the humeral components may provide a large, focused attractive force. In contrast, orienting the magnetic directions of the magnet systems may provide a more diffuse or unfocussed repelling force.
  • a biasing system may comprise a torsion spring that also functions as the axis of rotation.
  • a torsion spring may comprise a rod anchored or attached at one end of the prosthesis, such as, for example, one side of the humeral component.
  • a mid portion of the torsion rod may have a splined or shaped cross section configured to structurally engage with the ulnar component.
  • the joint can be assembled such that the null condition of the torsion spring is the desired null position of the joint, for example, 60 degrees of flexion. As the joint increases or decreases flexion from the null position, the torsion spring will bias the joint back to the null position.
  • a spring may comprise a splined or shaped end for non-rotating engagement with a portion of the humeral component.
  • the other end of the spring may comprise a hub, such a disk-shaped portion to which the spring is affixed or integrated.
  • another portion of the humeral component has an opening configured to receive the spring hub.
  • the joint can be assembled by inserting the spring through the opening in the humeral opening, through the ulnar bearing components, the ulnar component and into the receptable in the humeral component as shown in FIG. 11.
  • a lock screw, as illustrated in FIG. 10 can secure the spring hub to the humeral component.
  • the spring force can be adjusted by no securing the hub to the femoral component and relying only on the shaped end of the torsion spring to react the biasing force.
  • one or more positional (e.g., flexion) detents, friction surfaces or camming surface can be employed to favor or disfavor particular orientations, such as degrees of flexion or rotation.
  • the biasing system illustrated in FIG. 11 may be combined with other biasing or braking systems, such as, but not limited to, a magnet system that further attracts or repels the joint from the null or biased condition.
  • FIG. 12 Illustrated in FIG. 12 is a conventional implantable ankle prothesis comprising a tibial component implanted in the tibia, including a pad component, and a talar component implanted in the talus.
  • FIG. 13 illustrates an ankle prosthesis utilizing aspects of the inventions disclosed herein.
  • one or more magnets may be embedded or formed the pad component and corresponding magnets, or material susceptible to magnetic fields may be embedded or integrated in the talar component to bias the ankle joint to the desired flexion condition.
  • the magnets can be embedded, as described above, in modified portions of the tibial component and/or modified talar component.
  • multiple magnet systems or other biasing or braking systems can be utilized to provide one or more bias point of attraction or repulsion (planar or rotational).
  • FIGs. 14A and 14B illustrate embodiments of implantable shoulder prothesis utilizing aspects of the inventions disclosed herein with respect to knee prostheses, elbow prostheses, and ankle protheses. Regardless of whether the shoulder prothesis is implanted in a conventional orientation in which the cup is located in the glenoidal cavity, and the associated ball is located on the end of the humerus, FIG. 14A, or a reverse orientation as illustrated in FIG. 14B, one or more of the biasing or braking systems disclosed herein may be implemented.
  • a magnetic biasing system may be embedded in the appropriate components.
  • rod-shaped magnets are embedded, as described previously, in both the ball and the cup to cause through magnetic attraction adduction of the arm.
  • magnets can be embedded, for example, on opposite sides of the ball and cup to repel the arm in adduction.
  • a non-load bearing ring of plastic such as HDPE or UHWMPE may surround the periphery of the cup into which magnets are embedded or housed at the appropriate location or locations to achieve the desired bias of the joint.
  • FIG. 15 illustrates an implantable hip prosthesis having a biasing system as disclosed and described herein.
  • FIG. 15 shows one embodiment in which one or more magnets are embedded in the femoral ball or shank portion and one or more magnets embedded in the cup, non-load bearing ring about the cup or portion of the prothesis designed and configured to house the biasing magnets. While the implantable prosthesis illustrated in FIG. 15 is the conventional orientation, those of skill will understand that reverse orientation hip prosthesis can utilize the biasing systems disclosed herein.
  • the magnetic material whether permanent, diamagnetic, paramagnetic, ferromagnetic, ferrimagnetic, or antiferromagnetic, or a combination, be structurally embedded in the implantable substrate, such as a titanium alloy or stainless steel, and be sealed, such as by welding or brazing therein against biomedical infiltration and compromise.
  • any one or more of the biasing or braking systems or mechanisms described for any of the prosthetic joint herein can be implemented in any other prosthetic joint.
  • the hydraulic biasing system described with respect to the knee prosthesis herein may be adapted and utilized on an ankle prosthesis, an elbow prosthesis, a shoulder prosthesis, or a hip prosthesis without departing from the scope of the inventions we have created.
  • a "smart" joint may be configured to communicate with wearable sensors, such as accelerometers, position sensors, angle sensors, pressure sensors, and/or load sensors to selfadjust ranges, limits and/or functions of the implanted prosthetic joint (or joints) for a particular person and/or for particular situations.
  • wearable sensors such as accelerometers, position sensors, angle sensors, pressure sensors, and/or load sensors to selfadjust ranges, limits and/or functions of the implanted prosthetic joint (or joints) for a particular person and/or for particular situations.
  • a "smart" implantable prosthetic joint system 602 may receive inputs from wearable sensors, such as one or more sensors in a person's belt 604a, clothing 604b, shoes 604c, 604d or the like to set ranges and limitations of the system 602.
  • wearable sensors such as one or more sensors in a person's belt 604a, clothing 604b, shoes 604c, 604d or the like to set ranges and limitations of the system 602.
  • These articles of clothing have the advantage that they are normally worn at specific locations relative to the prothesis and for specific activities. Placing sensors in belts, shoes and/or clothing is also much less encumbering than having to wear a sensor that would have to be applied at a specific location on a body.
  • the inventions disclosed herein may make use of sensors removably or permanently attached to the body.
  • implanted sensors with muscles that indicate muscle activation and direction also may be used with the prostheses contemplated herein.
  • sensors in the belt 604a may relay pressure changes such as may be a contraction of a dorsi or gluteal muscle that may be a precursor to a push off step if the shoe sensor identifies that the legs are fully extended — e.g., the ipsilateral shoe is at a maximum distance below, e.g., the "smart" knee 602 and the contralateral shoe is appropriately nearby as would be normal for a stance.
  • a small pressure change detected along the belt may indicate that the wearer is preparing to take a small or normal step.
  • the "smart" prosthesis 602 may then process these signals and make instantaneous adjustments to its limits and ranges in anticipation of this activity.
  • the collection of sensors may indicate that the shoes 604c, 604d are nearing the belt 604a. If the belt 604a is substantially vertically above the shoes, the "smart" knee 602 may anticipate that the wearer is crouching or perhaps preparing to sit. However, if the belt is offset from the shoes, it may be anticipated that the wearer is preparing to kneel.
  • Algorithms may be implemented in the smart prothesis 602 (knee), 1602 (elbow), 1604 (shoulder), 1606 (ankle) and/or 1608 (hip) to temporarily adjust an amount of friction, resistance, or bias to the anticipated movement, Appropriate adjustments may be made to the ranges, limits, and even to the biasing of the "smart" joint for these interpreted sensor inputs.
  • the pressures of the fronts and backs of the soles of the feet 604c, 604d in relationship to the distance between the feet may indicate that the wearer is walking or running. Greater pressure differences and longer strides may indicate running, which may require a larger extension bias than a normal walking stride. Similarly, sensing that one shoe has no sole pressure 604d while also sensing a rise in elevation may indicate the need to make adjustments in one or more of the smarts joint 602 (knee), 1602 (elbow), 1604 (shoulder), 1606 (ankle) and/or 1608 (hip).
  • sensors in a belt and shoes in relation to the prosthetic knee Applicants envision embodiments with other sensors worn or placed on the body and used in relation to other implantable smart joints 602 (knee), 1602 (elbow), 1604 (shoulder), 1606 (ankle) and/or 1608 (hip). Without limitation, these may include appropriate sensors in wrist watches 612, rings 616, bracelets 612, necklaces, piercings, and any other device that may be worn on the body. Sensors that rely on a distance from a "smart" joint should maintain a relatively stable position relative to the body or relative to the joint or joints they support.
  • Embodiments of inventions described herein may include sensors that monitor and relay other information such as, but not limited to, temperature, direction of gaze, respiration, heartbeat (all of which may be used as indicators of upcoming movements requiring smart joint adjustment).
  • Smart joints such as 602 (knee), 1602 (elbow), 1604 (shoulder), 1606
  • NFC near field communication
  • BLE Bluetooth low energy
  • a first "smart" knee 602 may work in tandem with a second smart knee 614.
  • a first smart shoulder 1604 may work in tandem with a second smart shoulder (not shown)
  • One or more sensors embedded in the first and second smart prosthetic may allow each smart joint to monitor the activity (including inactivity) of the other joint to for use by the movement algorithm in creating the desired amount of functionality (e.g., resistance to flexion).
  • external sensor may be worn on clothing, such as pants or shirts, adjacent each smart joint. While this example includes joints of the same type, it will be understood that dissimilar smart joints, such as knee 602 and hip 1608 joints can work in tandem in similar fashion.
  • the " smart" joints may communicate with each other in ways that are similar to how they would communicate with sensors. However, this may entail propagating radio frequency signals from a transmitter inside the body to a receiver that is also inside the body, which may not be efficient. Applicants envision that in addition to the methods described within this specification and others that would be known to those ordinarily skilled in the appropriate art, other means of communication may be deployed. Some examples, without limitation, may include electrically conductive media, such as a wire or wires, that may be subcutaneously inserted to facilitate these communications.
  • These " smart" joints may also receive configuration commands from external devices and may transmit data to external devices.
  • a person with a “smart” joint may link the “smart" joint to their cell phone 616 or other similar device using known wireless communication and/or telemetry protocols.
  • the cell phone 616 or other device may make use of application software designed and configured to interface with the smart joint. For example, before a patient begins a jog or brisk walk, the patient may “program” a smart joint to a desired level of functionality. Similarly, while jogging or walking, the patient may program or reprogram the smart joint as desired.
  • a "smart" joint application may work in tandem with a map feature to geographically locate the person and anticipate their direction and speed and send configuration commands to the "smart" joint. For example, if the map feature indicates that the person is approaching a steep incline, the cell phone may instruct the "smart" joint to set ranges, limits, and biases to appropriate settings for climbing. The ranges, limits, and biases may be kept there until the map feature indicates that the person has moved to different terrain.
  • FIG. 6B illustrates an embodiment of a control system 650 comprising a controller 652, a power system 654, the structural and or operational components 656 in the prosthesis that can be adjusted or controlled, such as, without limitation, a prosthetic biasing system and/or a prosthetic resistance mechanism, or both.
  • the controller 652 preferably comprises a microprocessor subsystem 658 configured to execute algorithms (software), firmware and other logic control instructions.
  • the microprocessor subsystem 658 is configured communicate with a communication subsystem 660, such as over bus 668.
  • Communication subsystem 660 is configured to receive data from one or more internal or external sensors, as described above, and to communicate such data to the microprocessor subsystem 658 over bus 668.
  • the communication system 660 also may be configured to communicate with external smart devices running dedicated application software, as described above. It will be appreciated that the communication protocol implemented and executed by the control system 652 preferably will be a combination of wired and wireless protocols. For example, and not limitation, sensor internal to the prosthesis may be wired to the communication subsystem 660, and sensors external to the prosthesis, such as, but not limited to, belt sensor 604a, may communicate wirelessly.
  • the controller 652 may comprise a memory subsystem 662 configured to store 664 the prosthetic control and learning algorithms, firmware, and other algorithms, as well as store sensor data and software data, such as generated control instructions.
  • the memory subsystem 662 may preferably comprise a rolling buffer 666 configured to receive the raw sensor data.
  • the algorithms executed by the microprocessor 658 may sample the sensor data in the rolling buffer 666 at periodic intervals.
  • a communication bus 667 transfers data at least between microprocessor 658 and memory subsystem 662.
  • the controller 652 and power subsystem 654 are integrally associated with the prosthetic body or envelope that is implanted in the human knee space.
  • the controller 652 and power subsystem 654 may be packaged to reside in a portion of the prosthetic stem, or in the prosthetic joint between the stems.
  • the control controller 652 and/or power subsystem 654 may be implanted in locations in the body separated from the prosthesis and be operationally connected to the prosthetic knee 656 through wired solutions.
  • the power subsystem 654 may be in an area of the human body that allows better access for power subsystem 654 replacement or recharging.
  • the power subsystem 654 may comprise a transdermal access port 655 configured to permit recharging of the power subsystem using a smart needle or other such device. Additionally, the transdermal port 655 also may allow transdermal data transfer to the controller 602.
  • FIG. 7 illustrate one of many algorithms or software useful with embodiments of the present inventions.
  • flow chart 702 illustrates the logical progression of a top-level algorithm for a smart prosthesis.
  • the smart joint such as 602 (knees), 1602 (elbows), 1604 (shoulders), 1606 (ankles) and/or 1608 (hips) comprises a microprocessor or controller 750 configured, such as through software or firmware, to receive information or data from one or more sensors 752.
  • these sensor(s) 752 may be external to the prosthetic 766, as such as, but not limited to, a belt sensor 604a, and/or may be an internal sensor associated with the prosthetic, such as, but limited to, an angular position sensor, or an accelerometer.
  • the controller 750 receives data from one or more of the sensors 752.
  • the controller 750 also maybe configured, such as through firmware or software, to receive data from an external smart device running a dedicated software application associated with the prosthetic 766.
  • the external smart device may comprise smart phone 616.
  • the data may be analyzed or processed by prosthetic control algorithm 756, which algorithms may or may not comprise machine learning or artificial intelligence learning capabilities. It will be understood by those of skill having benefit of this disclosure that prosthetic control algorithms 756 may be configured and implemented to adjust, vary or control one or more structural or operational characteristics or functions of the prosthetic knee.
  • step 710 the memory system 758 of controller 750 may be updated with some or all of the sensor 752 data and/or with status information generated by the prosthetic control algorithms and/or the learning algorithms.
  • the prosthetic control algorithms 756 may generate one or more control instructions 760 from the sensor data 752, application data 754, and/or learned data.
  • the one or more control instructions 760 may be configured to be received by the one or more adjustable or controllable structures or features of the prosthesis, such as, but not limited, the prosthetic extensor mechanism and/or the prosthetic resistance mechanism.
  • the one or more control instructions 768 are used to adjust, vary or control one or more structural 762 or operational 764 characteristics or functions of the prosthetic knee 766.
  • the algorithm may be configured to loop 770 back to step 708 to analyze new (e.g., new in time) data from the various data sources to determine whether further changes to structural 762 and/or operational 764 characteristics of the prosthesis are needed or desired. For example, and not limitation, if one or more sensor data indicates a period of inactivity over a predetermined period, the algorithms 756 may conclude that the patient is asleep or resting, and the prosthesis and controller 750 may enter a sleep or inactivity mode to conserve power resources.
  • new e.g., new in time
  • the implantable joint preferably comprises a biasing mechanism, which may be a controllable biasing mechanism in a smart embodiment, that biases the joint to the extended position, e.g. 0 degrees flexion, or to some other position, orientation, or alignment.
  • the biasing force i.e., the force that tends to move the joint to a null position
  • the biasing force may be overcome by inertia during movement of the limb.
  • too much of a biasing force may simulate a fused joint.
  • Different biasing forces may be provided for various levels of activity. For example, a more active person may require a greater biasing force that a more sedentary person.
  • certain embodiments of the joints disclosed herein may have an adjustable or varying biasing force.
  • a small tool may be surgically inserted to the joint 602 (knee), 1602 (elbow), 1604 (shoulder), 1606 (ankle) and/or 1608 (hip) to adjust the biasing force, such as by rotating a screw or other component in the joint.
  • a non-surgical example may comprise an external device configured to electronically link to a microprocessor or logic circuit in the joint 602 (knee), 1602 (elbow), 1604 (shoulder), 1606 (ankle) and/or 1608 (hip), such as by magnetic coupling, Bluetooth, or other near field communication protocol, to adjust the bias force or forces, or to adjust operability of the extensor mechanism.
  • a linear motor may be part of the prosthetic elbow and a controller in the joint may adjust the motor to adjust, e.g., the biasing force, or brake force.
  • an adjustable rotary orifice may be controlled or adjusted for hydraulic or pneumatic biasing or braking systems in the joint.
  • the magnetic direction or strength of implanted magnets may be adjusted or changed to effect a desired bias or resistance to joint movement.
  • a computerized or "smart" joint may be manufactured with a private encryption key and one or more public keys of the manufacturer. It may be configured to only use encrypted communications such that anyone desiring to communicate with the "smart" joint would then need to use a device that has a key signed by the manufacturer.
  • a magnetically activated adjustment mechanism may be held in a locked state until an authorized and/or authenticated signal has been received through a data communications link.
  • those ordinarily skilled in the art may make use of multiple magnetic fields to lock and unlock a magnetically activated adjustment mechanism.
  • a fixed field of specific strength oriented in one direction may unlock the mechanism while a movable magnet may associate with the mechanism to make adjustments. Removal of the fixed and oriented field may reengage the lock.
  • suitable bio sheaths may include silicon, silicon oxide, silicon nitride, stainless steel mesh or other biocompatible materials.
  • bio sheath if implemented, should be flexible or deformable enough to accommodate at least the desired range of flexion and rotation, as well as provide the desired amount of separation, encapsulation or protection of the moving components.
  • Other and further embodiments utilizing one or more aspects of the inventions described above can be devised without departing from the spirit of our inventions.
  • the various methods and embodiments of the methods of manufacture and assembly of the system, as well as location specifications can be included in combination with each other to produce variations of the disclosed methods and embodiments. Discussion of singular elements can include plural elements and vice-versa.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

Une prothèse pour remplacer une articulation humaine, comprenant : un premier composant comprenant une première partie d'articulation prothétique et une première partie tige intermédullaire, la première partie tige étant configurée pour être incorporée dans un os associé au premier composant; un second composant comprenant une seconde partie d'articulation prothétique et une seconde partie tige intermédullaire, la seconde partie tige étant configurée pour être incorporée dans un os associé au second composant; une articulation prothétique comprenant le premier composant couplé de manière fonctionnelle au second composant d'articulation, fournissant ainsi l'articulation prothétique avec une plage de mouvement du premier composant par rapport au second composant; un système de sollicitation couplé de manière fonctionnelle à l'articulation prothétique, les premier et second composants étant sollicités vers une position prédéterminée lorsque la prothèse est implantée chez un être humain pour remplacer l'articulation humaine.
PCT/US2023/064497 2022-07-08 2023-03-15 Prothèse articulaire implantable avec systèmes de sollicitation intégrés WO2024010989A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US63/049,612 2020-07-08
US202263049612P 2022-07-08 2022-07-08

Publications (1)

Publication Number Publication Date
WO2024010989A1 true WO2024010989A1 (fr) 2024-01-11

Family

ID=89453987

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/064497 WO2024010989A1 (fr) 2022-07-08 2023-03-15 Prothèse articulaire implantable avec systèmes de sollicitation intégrés

Country Status (1)

Country Link
WO (1) WO2024010989A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7195645B2 (en) * 2003-07-11 2007-03-27 Depuy Products, Inc. In vivo joint space measurement device and method
US20080097606A1 (en) * 2006-10-19 2008-04-24 Cragg Andrew H Knee joint prosthesis and hyaluronate compositions for treatment of osteoarthritis
US8888856B2 (en) * 2009-01-27 2014-11-18 Zimmer, Inc. Total knee implant
US20190274834A1 (en) * 2018-03-09 2019-09-12 Stephen Bramblett Johnson Magnetic prosthetic
US20210267764A1 (en) * 2020-02-28 2021-09-02 Extensor, LLC Implantable Knee Prosthesis with Integrated Prosthetic Extensor Mechanism.

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7195645B2 (en) * 2003-07-11 2007-03-27 Depuy Products, Inc. In vivo joint space measurement device and method
US20080097606A1 (en) * 2006-10-19 2008-04-24 Cragg Andrew H Knee joint prosthesis and hyaluronate compositions for treatment of osteoarthritis
US8888856B2 (en) * 2009-01-27 2014-11-18 Zimmer, Inc. Total knee implant
US20190274834A1 (en) * 2018-03-09 2019-09-12 Stephen Bramblett Johnson Magnetic prosthetic
US20210267764A1 (en) * 2020-02-28 2021-09-02 Extensor, LLC Implantable Knee Prosthesis with Integrated Prosthetic Extensor Mechanism.

Similar Documents

Publication Publication Date Title
JP7036408B2 (ja) 半能動ロボット関節
Crago et al. An elbow extension neuroprosthesis for individuals with tetraplegia
Willemsen et al. Automatic stance-swing phase detection from accelerometer data for peroneal nerve stimulation
US8532786B2 (en) Neural prosthesis
US20160287398A1 (en) Lockable implants and related methods
EP3678609B1 (fr) Emboîture de membre artificiel
US20220280301A1 (en) Responsive Biomechanical Implants and Devices
US20100145464A1 (en) Device and method for force management within a joint
EP1555968A1 (fr) Procede et appareil de commande de dispositif ou de procede a l'aide de vibrations produites par des clics de dents
US20230363929A1 (en) Implantable Joint Prosthesis with Integrated Biasing Systems
WO2003065938A1 (fr) Ensemble de prothese
WO2024010989A1 (fr) Prothèse articulaire implantable avec systèmes de sollicitation intégrés
JP2023516304A (ja) 一体化された人工関節伸筋機構を有する植え込み可能な人工膝関節
WO2023031046A1 (fr) Dispositif de restriction d'urètre implantable
WO2023031045A1 (fr) Dispositif de restriction
Kilgore Sensors for motor neuroprostheses
US20210401592A1 (en) Prosthesis comprising a programmed magnetic interlock
CA3228110A1 (fr) Dispositif de restriction
AU2022338977A1 (en) Restriction device
WO2023156574A1 (fr) Appareil et procédé pour obtenir un contrôle urinaire
CA3230660A1 (fr) Appareil et procede permettant d'obtenir un controle urinaire
GB2606264A (en) Prosthetic Limb Socket
CA3228283A1 (fr) Systeme d'administration de medicament
KONG et al. Portable gait-event detection system with built-in wireless sensor configuration
WO2023280859A1 (fr) Traitement d'une maladie de reflux gastro-oesophagien

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23836181

Country of ref document: EP

Kind code of ref document: A1