WO2025037258A1 - Smart and expandable articular joint implant device, system and method - Google Patents
Smart and expandable articular joint implant device, system and method Download PDFInfo
- Publication number
- WO2025037258A1 WO2025037258A1 PCT/IB2024/057904 IB2024057904W WO2025037258A1 WO 2025037258 A1 WO2025037258 A1 WO 2025037258A1 IB 2024057904 W IB2024057904 W IB 2024057904W WO 2025037258 A1 WO2025037258 A1 WO 2025037258A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- joint replacement
- expandable
- implantable
- sensors
- expanding member
- Prior art date
Links
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Classifications
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- A61F2002/4022—Heads or epiphyseal parts of humerus having a concave shape, e.g. hemispherical cups
Definitions
- Bones, muscles, ligaments, or tendons in a body can become injured and may benefit from medical assistance in order to heal, resolve, or account for the injury.
- At least one aspect is directed toward an implantable joint replacement device having multiple joint replacement device components.
- the implantable prosthetic joint replacement device includes multiple joint replacement device components and an expandable joint replacement device body that receives a first joint replacement device component.
- the expandable device body is coupled with a second stemmed joint replacement device component.
- the expandable device body includes an expanding member that supports an articulating piece to contact with a second joint replacement device component.
- the expandable device body can expand axially via its expanding member to change a height of the expandable device body within a range from 0 to 10 millimeters.
- the expanding member includes a plurality of sensors to detect or measure at least one physical metric applied onto or related to the expanding member or the expandable device body. This plurality of sensors is embodied within a closed internal module, with the internal module communicating with an external module.
- At least one aspect is directed toward an implantable reverse shoulder arthroplasty device that includes a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component.
- the expandable proximal humeral body includes an expanding member to support a humeral liner to receive the glenosphere component, and includes a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member.
- the rotating member includes, at an outer circumferential portion, a rack with a plurality of gear teeth and can be rotated by the action on the rack and gear teeth of an external tool having a pinion-like end, and can cause the expanding member to move axially and to change a height of the expandable proximal humeral body within a range from 0 to 10 millimeters.
- the expandable proximal humeral body includes a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner.
- the plurality of sensors are embodied within a closed internal module, with the internal module communicating with an external module.
- At least one aspect of the disclosure is directed toward a joint replacement system that includes an implantable prosthetic joint replacement device.
- the implantable prosthetic joint replacement device has multiple joint replacement device components and includes an expandable joint replacement device body to receive a first joint replacement device component and to couple with a second stemmed joint replacement device component.
- the expandable device body includes an expanding member to support an articulating piece to contact with the first joint replacement device component, and a rotating member that is movably engaged, via a plurality of corrugations and threads, with the expanding member.
- the rotating member can be being rotatably driven, via a rack with a plurality of gear teeth at an outer circumferential portion, by engaging the rack and gear-teeth with a pinion-like end of an external tool to drive the expanding member into an axial movement to change a height of the expandable device body within a range from 0 to 10 millimeters.
- the expanding member includes a plurality of sensors coupled at a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member and/or expandable device body.
- the joint replacement system includes an external module or hardware that communicably couples with the closed internal module and the plurality of sensors in the expandable device body.
- the joint replacement system includes a computing device that supports a data processing system, collects the physical metric, and renders a graphical representation of the physical metric being applied onto or related to the expandable device body.
- the physical metric can be related to the height of said expandable device body as well as to other parameters.
- At least one aspect of the disclosure is directed toward a shoulder arthroplasty system that includes an implantable reverse shoulder arthroplasty device, having a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component.
- the shoulder arthroplasty system includes an external module or hardware to communicably couple with the closed internal module the plurality of sensors, a computing device to support a data processing system, collect the physical metric, and to render graphical representation of the physical metric, and an external anatomical indicator system to determine the anatomical position of the limb where the implantable reverse shoulder arthroplasty device is installed the and to communicably couple with the computing device and data processing system.
- the expandable proximal humeral body includes an expanding member to support a humeral liner to receive the glenosphere component, and a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member.
- the rotating member includes, at an outer circumferential portion a rack with a plurality of gear teeth and can be rotated by the action on the rack and gear teeth of an external tool having a pinion-like end and, being driven, it causes the expanding member to move axially to change a height of the expandable proximal humeral body within a range from 0 to 10 millimeters.
- the expandable proximal humeral body includes a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner.
- the physical metric applied onto or related to the expandable proximal humeral body can be rendered and can be related to the height of the expandable proximal humeral body and to the anatomical position of the corresponding limb.
- At least one aspect is directed toward a method of using a joint replacement system that includes an implantable prosthetic joint replacement device with an installed first joint replacement device component and an installed second stemmed joint replacement device component.
- the expandable joint replacement device body can be coupled with the installed second stemmed joint replacement device component.
- the method includes measuring, via a plurality of sensors located on one expanding member of the expandable device body, at least one physical metric being related to or applied onto this expanding member, and moving, via an external tool, an expanding member of the expandable device body, the movement being axial and causing a change of a height of the expandable device body of the joint replacement device, and displaying or rendering, via a data processing system in a computing device, a representation of the physical metric related to or applied onto the expanding member of this expandable device body.
- At least one aspect is directed toward a method of using a shoulder arthroplasty system including an implantable reverse shoulder arthroplasty device having an installed first glenosphere component and an installed second humeral stemmed component, where an expandable proximal humeral body is coupled with the installed humeral stem component.
- the method includes measuring, via a plurality of sensors located on an expanding member of the proximal humeral body, a load magnitude and a center of load position being applied onto the expanding member, and rendering, via a data processing system in a computing device, a representation of the load magnitude and the center of load position applied onto the expanding member of the expandable proximal humeral body.
- FIG. 1 shows example schematic side views of joint replacement prosthesis devices.
- FIG. 2 shows an example side view of an implantable joint replacement prosthesis device and components.
- FIG. 3 shows a side perspective view of a device body and components of an implantable joint replacement device.
- FIG. 4 shows another side perspective view of a device body and components of an implantable joint replacement device.
- FIG. 5 shows another side perspective view of a device body and components of an implantable joint replacement device.
- FIG. 6 shows another side perspective view of a device body and components of an implantable joint replacement device.
- FIGS. 7A-7E show various views of a device body and components of an implantable joint replacement device: FIG. 7A shows a side view of a device body and components of an implantable joint replacement device; FIG. 7B shows perspective views of the device body and use; FIG. 7C shows another side view of the device body incorporating an external locking system; FIG. 7D shows perspective views for device bodies incorporating an internal locking system; FIG. 7E shows perspective views for device bodies incorporating a locking system.
- FIGS. 8A-8B show example views of a prosthetic expanding device body of the joint implant device and an internal module and the components of the internal module.
- FIG. 9 shows example views of the sensors installed on a deformable member or end of the prosthetic expanding device body of the joint replacement device.
- FIG. 10 shows an example view of the components of a joint replacement system.
- FIG. 11 shows an example workflow for the data in the joint replacement system.
- FIGS. 12A-12C show example user interfaces in the joint replacement system.
- FIG. 13 shows an example workflow for the use of the joint replacement system.
- FIG. 14 shows example views of the joint replacement system in a human shoulder joint.
- FIG. 15A-15B show example graphs showing load magnitude and center of load position of the joint replacement system installed into a shoulder joint.
- Various medical devices can support several bones, muscles, ligaments, or tendons in a body.
- Various prosthetic medical devices can be implanted to replace articular joints in a body.
- Some orthopedic surgery involves resurfacing, replacement, or reconstruction of ball-and-socket joints, such as in the shoulder or hip, the surgeon may want to evaluate the performances of a newly-implanted prosthetic joint device.
- the biomechanical stability of the joint device is a relevant characteristic, and it can be useful to determine whether the implanted joint device should have an additional adjustment during the surgery.
- One aspect of the joint performance for ball-and-socket joints resides in the load magnitude and center of load position depending on anatomical positions and ranges of motion.
- the present disclosure relates generally to orthopedic surgery and procedures and, more particularly, to assemblies, devices and systems that can help in performing joint replacements and arthroplasties.
- the present disclosure relates to an implantable joint replacement prosthesis or prosthesis component that provides various advantages, and particularly that of allowing an easier and less stressful intraoperative adjustment of the thickness or height of the prosthesis and the state of tightness or laxity of the joint replacement prosthesis being installed as well as an objectified intraoperative and postoperative follow-up monitoring of the state of tightness or laxity' of the implanted joint replacement prosthesis and/or prosthesis component.
- At least one aim of the present disclosure is to reduce or eliminate the subjectivity related to the evaluation of the state of tightness or laxity of a joint replacement prosthesis when being installed in the patient.
- At least one aim of the present disclosure is to enable a fast and easy adjustment of the size of an implantable joint replacement prosthesis or one of the prosthesis components whilst avoiding a removal of a joint replacement prosthesis component at each size adjustment.
- the adjustment of the thickness or height of one joint replacement prosthesis component may affect the state of tightness or laxity of a joint replacement prosthesis.
- At least one aim of the present disclosure is to enable the measuring, recording and displaying of one or more physical metric that is applied onto the installed joint replacement prosthesis or one prosthesis component.
- Such physical metric can be related to the state of tightness or laxity of a joint replacement prosthesis and can be also related to the tension of/from the surrounding soft tissues.
- At least one aim of the present disclosure is to provide a mean of evaluating and balancing the installation of an implantable joint replacement prosthesis or prosthesis component to reach a quantified and/or desired state of tightness or laxity. Therefore, during the installation of the joint replacement prosthesis, the surgeon can measure and quantify the current state of tightness or laxity of the joint replacement prosthesis component and can adjust intraoperatively the size of the joint replacement prosthesis component to reach an optimal state of tightness or laxity of the joint replacement prosthesis component. It is thus provided an objective mean of balancing the state of tightness or laxity of the joint replacement prosthesis component.
- At least one aim of the present disclosure is to provide a mean of measuring and quantifying post-surgery (postoperatively) the state of tightness or laxity of an implanted joint replacement prosthesis. Therefore, a quantitative and objective evaluation of the state of tightness or laxity of the implanted joint replacement prosthesis can be done during the postoperative follow up monitoring, especially in case of complications related to possible mechanical changes.
- the present disclosure generally refers to devices, systems and methods for evaluating a joint replacement prosthesis.
- the present disclosure refers generally to devices, systems and methods of evaluating a joint replacement prosthesis, determining a measurement of a physical metric related to the joint replacement prosthesis and displaying a measurement of a physical metric related to the joint replacement prosthesis.
- the present disclosure refers also to a method of balancing a joint replacement prosthesis during its installation/implantation, by adjusting a size of the joint replacement prosthesis based on the physical metric measured on the joint replacement prosthesis.
- This technical solution is generally directed to a medical device.
- this technical solution is generally directed to an implantable joint replacement prosthesis device, or a joint replacement implant device or a prosthetic joint implant device for coupling to a joint of a human body such as a shoulder joint, a hip joint, an ankle joint, an elbow joint, or a knee joint.
- the technical solution can also incorporate the medical device into a medical system or a method.
- the present disclosure generally refers to devices, systems and methods for evaluating a joint replacement implant device.
- the present disclosure refers generally to devices, systems and methods of evaluating a joint replacement implant device or one of the components, determining a measurement of physical metrics related to the joint replacement implant device or one of the components, and displaying a measurement of physical metrics related to the joint replacement implant device.
- the present disclosure refers also to a method of using the proposed devices and systems, for balancing a joint replacement implant device during the installation/implantation, such as though the state of laxity or tightness, by adjusting a size of the joint replacement implant device or one of the components based on the physical metric measured on the joint replacement implant device or one of the components.
- Joint replacement procedures are among the orthopedic surgical procedures and represents a major number of orthopedic surgical procedures including the total hip arthroplasty (THA) and total knee arthroplasty (TKA).
- TSA total hip arthroplasty
- TKA total knee arthroplasty
- the shoulder joint replacement through total shoulder arthroplasty (TSA) is expanding especially due to an increasing interest for reverse total shoulder arthroplasty (rTSA).
- the surgical incision is done, and the shoulder is exposed.
- the humeral preparation can be performed including the creation of the pilot hole through the humeral head along the axis of the humeral shaft, then an intramedullary resection guide step can be done prior to the humeral broaching.
- a calcar planer can be used to refine the resected surface, then the technique for the insertion of the humeral stem can be applied.
- the following steps can be for the preparation of the glenoid and the installation of the baseplate and glenosphere: glenoid preparation, baseplate impaction, selection/insertion of baseplate central and peripheral screws, the selection and assembly of the glenosphere and the orientation/impaction of the glenosphere.
- the humerus is again dislocated upwards and outwards taking care not to entrap the medial part of the metaphysis under the glenosphere.
- the trial humeral device is then positioned, and the prosthesis is reduced.
- the height of the metaphyseal element and/or the polyethylene insert can be chosen by testing of muscular tension.
- the final humeral component is fixed, whether it is monoblock or pre-assembled, with the diaphyseal component and the epiphysio-metaphyseal element.
- the surgical procedure is completed as normally for a reverse shoulder arthroplasty by repairing and adjusting the subscapularis and completing the surgery.
- joints of a human body are complex in nature.
- restoring the center of rotation can include evaluating soft tissue tension and balance about the joint, as the jointsurrounding soft tissues play a role in optimizing joint function for joint replacement surgery.
- Current joint replacement implants focus on bone anatomy and alignment without addressing soft tissue tension.
- optimizing soft tissue tension would provide several advantages.
- Conventional implants can include a fixed inclination and rely on subjective measures to cut bones to achieve the desired height, tilt, inclination, or rotation of the implant. Thus, achieving adequate soft tissue tension is difficult and there can be a need to detect tension or compression loads that apply at the joint and onto the joint implant.
- Various prosthesis joint replacement operations can employ a medical implant device that uses the deltoid muscle to restore shoulder functions.
- a medical implant device that uses the deltoid muscle to restore shoulder functions.
- anatomic shoulder replacements, or hemiarthro-plasty for example, surgeons can install a prosthesis or implant with some tension or compression on one or more muscles, such as the deltoid muscle.
- surgeons can maneuver the arm of a patient to subjectively evaluate the tension and stability of the joint (e.g., via patient feedback), which can be time consuming or ineffective due to a too high subjectivity.
- the shoulder joint case represents a good example because the shoulder joint can be totally replaced, and anatomic and reverse shoulder joint replacement implant devices are available to operate such joint replacements.
- the outcome can be dependent on a proper tension of the soft tissues surrounding the shoulder joint.
- the rotator cuff being absent, it is mainly from the deltoid tension that will come the stability of the shoulder joint, by holding the ball-and-socket (spheroid) joint together. So, for a reverse shoulder joint replacement, the stability (laxity or tightness) of the prosthetic shoulder joint should be as optimal as possible to avoid potential clinical and mechanical complications such as a joint dislocation.
- the surgeon evaluates the mechanical stability (laxity or tightness) of the shoulder joint replacement implant, before installing definitively the shoulder joint replacement implant.
- This can be achieved through a shoulder joint implant component, often defined as a liner, which is available in different sizes: the surgeon will perform a reduction of the shoulder joint to install a selected liner onto the humeral head and to evaluate the soft tissue tension.
- the joint reduction can use high forces to be applied onto the humerus and surrounding soft tissues. But, this operation will be repeated as desired with different liners and different liner sizes, until a correct liner is selected and a correct soft tissue tension is reached.
- the shoulder joint can be dislocated, and the surgeon can install the final shoulder joint replacement implant.
- the joint dislocation is another difficult step since it uses high forces to be applied. Therefore, such reduction and dislocation procedures are potentially difficult.
- an adjustable implantable joint replacement device that can reduce or expand the size of the device when being installed in position within the joint.
- an implantable humeral head or tray of a shoulder joint replacement device where the implantable humeral head or tray can be installed on a humeral stem, and where the humeral head or tray can be adjusted in size, such as in height of thickness, during the surgery, thus avoiding the reduction/dislocation process with the humeral liners.
- an implanted humeral tray or head that can be adjusted in height by the action of an non-implantable external tool that will be used to engage with and activate the adjusting mechanism within the humeral tray or head component of the shoulder joint replacement device.
- an implantable joint replacement device that can measure and report one or several physical metric(s) that apply onto the implantable joint replacement device or one of the components.
- an implantable joint replacement device that can measure or report joint load characteristics that are directly related to the tension of the soft tissues surrounding the implantable joint replacement device.
- an implantable shoulder joint replacement device that can measure and report the contact force load and center of load position at the ball-and-socket (spheroid) contact within the shoulder joint system. This force load magnitude and position are directly related to the stability, laxity or tightness, of the shoulder joint system and are directly impacted by the tension applied by surrounding soft tissues.
- an implantable joint replacement system that can enable to provide interrelated anatomical parameter(s), physical metric(s) and device data during the course of the installation of an implantable joint replacement device.
- an implantable shoulder joint system that can provide and interrelate data corresponding to the contact force load and center of load position within the shoulder joint system and data corresponding to the size of the shoulder joint device with data corresponding to the anatomical position of the arm where is installed the implantable shoulder joint device.
- Such a system would allow to display a dynamic view of the interrelations of the aforementioned data.
- the technical solution in the present disclosure aims at reducing the need for installing/removing device or component trials in order to establish the good stability level for an implantable joint replacement device.
- the present solution aims at reducing the trialing process performed by the surgeon during the installation of an implantable shoulder joint replacement device and the reduction/dislocation steps during this trialing.
- smart and expandable joint replacement devices and systems are proposed which will eliminate the subjective and potentially traumatic trialing during the installation of the joint replacement device.
- the present disclosure relates to an implantable joint replacement device that includes an adjusting mechanism that is incorporated within the body of one device component of the implantable joint replacement device to enable an easy increase or decrease of the height or thickness of the device component and of the joint replacement device.
- the adjusting mechanism in the joint replacement device may activated by a non-implantable external tool or instrument.
- a shoulder joint replacement device such as a reverse shoulder joint replacement device composed of multiple joint device components including a baseplate, a glenoid sphere, bone screws, a humeral stem, a humeral tray and a humeral liner
- the adjusting mechanism of the reverse shoulder joint replacement device can be incorporated within the humeral tray component.
- the implantable joint replacement device can include sensing capability that is incorporated within the body of one device component of the implantable joint replacement device to measure and report physical metrics applied onto one device component of the joint replacement device.
- One way of providing such a feature is to have a sensored device component with the implantable joint replacement device. Sensors can measure and provide surgeons with objective data regarding the orientation, location, and amplitude of force on the implantable joint replacement device. Furthermore, this technical solution can provide precise force magnitude and direction readings using sensors at a useful point of a ball-and-socket (spheroid) joint of the device.
- the humeral tray of the reverse shoulder joint replacement device can incorporate sensored elements to measure and report the contact force magnitude and orientation that apply onto the humeral liner and tray.
- the technical solution can propose a prosthetic joint implant where some adjustment can be brought with a less aggressive and simpler action such as using an instrument or tool.
- this technical solution can have many benefits over existing medical device evaluating systems. For example, by determining accurate and objective data measurements using various computing devices and sensors over an interface of a joint, the technical solution can provide more precise physical metrics of a medical device in comparison to manual evaluation techniques. Furthermore, since evaluation and adjustment techniques can be generated manually, such adjustments can be derived based on subjective data on a case-by-case and practitioner-by practitioner basis. This technical solution provides for real-time, repeatable, and accurate evaluation outcomes to more efficiently and effectively adjust a medical device to meet patient needs.
- FIG. 1 illustrates example partial side view schematics of an implantable prosthetic ball-and-socket (spheroid) joint replacement device 100 in which a “ball” component 101 articulates through an articulating surface 135 with a “socket” or cup 104, where the socket 104 can be received and coupled with a joint replacement device body 105 of the implantable joint replacement device 100.
- FIG. 2 illustrates an example implantable joint replacement device 100.
- the implantable prosthetic joint replacement device 100 can relate to various joints in a body such as a shoulder joint, a hip joint, an ankle joint, a knee joint, a wrist joint, an elbow joint, or another body joint. While the implantable joint replacement device 100 described in reference to the figures generally relates to a shoulder joint, such as a shoulder arthroplasty device, the implantable joint replacement device 100 can be used with various other joints.
- the implantable prosthetic joint replacement device 100 can generally include a first joint replacement device component (or “joint device component”) coupled with a first bone of the body joint and a second joint replacement device component (or “joint device component”) coupled with a second bone of the body joint.
- the implantable joint replacement device 100 can include a first joint device component having a convex surface or a ball 101, that can couple with a bone of the human or mammalian body joint through bone screws 103 and a second joint device component that can couple with another bone of the human or mammalian body joint through a stem 102.
- the implantable prosthetic joint replacement device 100 can include a concave component or socket 104 that receives the convex component or ball 101.
- the device can be a reverse total shoulder arthroscopy prosthesis, involving a humeral device component and a glenoid device component.
- ball 101 can be the glenoid sphere of the glenoid device component
- the socket 104 can be the humeral cup or liner
- the stem 102 can be the humeral stem of the humeral device component.
- the implantable prosthetic joint replacement device 100 and the components or parts can be made from various metallic or non-metallic materials that are currently used and accepted in long-term prosthetic joint replacement implants, including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- rigid metals and alloys chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like
- plastics polyethylene, such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like
- ceramics such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers
- the implantable prosthetic joint replacement device 100 can include at least one joint replacement device body component 105 (FIG. 1 and FIG. 2, among others).
- the joint replacement device body 105 can be made from various metallic or non-metallic materials that are currently used and accepted in long-term prosthetic joint replacement implants, including, but not limited to, chromium, nickel, stainless steels, titanium, alloys, plastics, polyethylene, such as ultra-high-molecular-weight polyethylene, polyether-etherketone (peek) or ceramics and the like.
- the device body 105 include several parts or members.
- one first member can act as an end to couple with or receive the socket 104 that will receive the first joint device component, such as the ball 101 (such as a glenoid sphere component), and another member can act as another opposite end to couple with the second joint device component, such as the stem 102.
- the first joint device component such as the ball 101 (such as a glenoid sphere component)
- another member can act as another opposite end to couple with the second joint device component, such as the stem 102.
- the joint replacement device components can include bone screws 103, a baseplate 106, the glenosphere ball 101, the humeral liner or socket 104, a humeral tray, 105 or a humeral stem 102.
- the joint replacement device body 105 can include an expandable joint replacement device body (expandable body device) that includes an expanding member or end 110.
- the expanding member or end, also called first member or first end 110 can correspond in shape with the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.).
- the implantable joint replacement device 100 and the expandable device body 105 can have a common rotation axis 200.
- the first member or end 110 have a specific shape, a grail or chalice shape, including an upper bowl portion 113 with a rim 111 and a guiding concave surface 125 to support the socket or liner 104 that will receive the first joint component, such as a convex part or ball 101, a short stem 112 and a lower foot/base 114 with a lower surface 115.
- the first joint component such as a convex part or ball 101, a short stem 112 and a lower foot/base 114 with a lower surface 115.
- the mechanical loads at the joint contact that are applied from the first joint device component onto the socket or liner 104, can be transmitted to the first end 110 and the structure to the expandable device body 105.
- the first member 110 can be a deformable member, so that the load-induced deformations applied from the bowl portion 113 and guiding concave surface 125 to the lower foot/base 114 and lower surface 115. Therefore, a contact load applied onto the first end/deformable member 110 can be determined through microdeformations detected at the lower surface 115 of the lower foot/base 114. Moreover, the grail/chalice shape of the first member 110 can support and withstand the maximum mechanical loads applied by the first joint device component onto the socket or liner 104 to the first member 110 and to the expandable device body 105.
- the socket or liner 104 can be of various shapes (symmetric or non, with angulation or not) and can be clipped and removable easily from the member 110.
- the expandable device body 105 of the implantable joint replacement device 100 can include a second member 120.
- the second member 120 can be the end of the expandable device body 105 that can couple to a second joint device component, such as a stem 102 such as a humeral stem via an attachment projection 130.
- the second member 120 can be coupled with a second joint device component 102 through a taper connection, a taper connection plus a screw, a screw, and other types of connection.
- the attachment projection 130 can include a taper, hole, slot, aperture, or other similar opening for receiving a portion of the second joint device component.
- the second member or end 120 can oppose the first member or end 110, as shown throughout the figures (FIG. 3).
- the second member 120 can correspond in shape with the first member 110 and the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.).
- the expandable device body 105, the first member 110 and the second member 120 can have a common rotation axis 200.
- the expandable device body 105 can include an arcuate or angled shape such that the first member 110 and the second member 120 are disposed at an angle.
- the first member 110 can be an expanding or extension member. For example, it can move relatively to the second basis member 120.
- the first member 110 can move longitudinally along the axis relative to the second basis member 120, and therefore the expandable device body 105 can expand or diminish longitudinally between the first 110 and second 120 members or ends.
- the height or thickness of the expandable device body 105 can be defined as a length between one axial point of the second member 120 and one axial point of the first member 110, can expand and diminish.
- an external activation can be applied onto the first member 110 thus inducing the movement of the expanding member 110 in the expandable device body 105.
- Various means of activation and extension are discussed herein.
- the implantable prosthetic joint replacement device 100 can include an expandable device body 105 and a socket/liner 104.
- the expandable device body 105 can include a first member 110 and a second member 120 with the attachment projection 130.
- the first end or member 110 can be an expanding member and a deformable member of the expandable device body 105.
- the first end or member 110 can be a deformable member and can be coupled with another expanding member 150 of the expandable device body 105.
- the first member 110 can couple with several other members or supports within the expandable device body 105.
- the expandable device body 105 can include another rotating member 140, rotatably coupled with the second member or end 120 and the expanding member 150.
- This rotating member 140 can rotate around the longitudinal axis 200 of the expandable device body 105, relative to the second member 120 and the expanding member 150.
- the rotating member 140 can rotate and may not translate relative to the second basis member 120.
- the rotating member 140 can correspond in shape with the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.).
- the rotating member 140 can have a complete cylindrical shape along the central axis, or the rotating member 140 can have an incomplete cylindrical shape such as an incomplete circular ring.
- the first member 110 of the expandable device body 105 can be designed, shaped, as well as made of a material with determined (or calibrated) structural integrity, such that pressures, loads or forces acting on the socket 104, on the guiding concave surface 125, and on the first end and member 110 are transferred one way or another to a lower portion of the first end and member 110 such as the lower foot/base 114 and lower surface 115 where are installed the load sensors 600.
- the first member 110 of the expandable device body 105 can be designed, shaped, as well as made of a material with sufficient structural integrity to physically resist the maximal loads applied onto the first member 110 and to provide the desired endurance to the first member 110 of the expandable device body 105.
- the rotating member 140 can include a plurality of corrugations 210 at the internal surface, and the expanding member 150 can include a plurality of corrugations 220 at the external surface.
- the plurality of corrugations 210 can engage with the plurality of corrugations 220 so that the members 150 and 140 are movably coupled: the rotating member 140 can rotate axially relative to the expanding member 150 and the expanding member 150 can move axially (longitudinally) relative to the member 140.
- the expanding member 150 can include a first gear 230 at the external surface or the rotating member 140 can include a first gear 230 at the external surface. This first gear 230 can be linear or circular. In some cases, the longitudinal movement (along the axis) of the expanding member 150 can be actioned through the activation of this external first gear 230 by a second gear 310 located at the extremity 305 of an external tool 300.
- an expandable device body 105 of an implantable prosthetic joint replacement device 100 can include one first member or end 110 coupled with one expanding member 150.
- This first expanding member 150 can have a plurality of corrugations 220, such as oriented buttress threads, and an axial gear rack 230 at the outer surface.
- the main expandable device body 105 of the joint replacement device 100 can include a second member or end 120 that is rotatably coupled with a rotating member 140.
- This second rotating member 140 can have the shape of a deformable incomplete ring and can include a plurality of corrugations 210, such as oriented buttress threads, at the inner surface.
- the first expanding member 150 movably couples with the second member 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both expanding member 150 and second member 120 are rotatably blocked though rotation retainer elements.
- An external tool 300 having a pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the expanding member 150.
- a unidirectional and/or longitudinal movement of the expanding member 150 can be made possible through the deformation of the rotating member 140.
- the moving of the expanding member 150 can be incremental and unidirectional depending on the thread geometry.
- the rotating member 140 can be externally deformed to disengage the oriented buttress threads 210 and 220. This can result in a displacement of the expanding member 150 relative to the rotating member 140, thus an increase of the total height or thickness of the expandable device body 105.
- a full bidirectional movement of the expanding member 150 relative to the rotating member 140 and to the second member 120 of the expandable device body 105 can occur when the rotating member 140 is deformed and the plurality of corrugations 210 is disengaged from the plurality of corrugations 220 of the expanding member 150.
- the expandable device body 105 of an implantable joint replacement device 100 can include one first end or member 110 coupled with one expanding member 150.
- This expanding member 150 can have a plurality of corrugations 220 and an axial gear rack 230 at the outer surface.
- the expandable device body 105 of the implantable joint replacement device 100 can include a second basis member 120 that is rotatably coupled with a rotating member 140.
- This rotating member 140 can include a plurality of corrugations 210 at the inner surface.
- the expanding member 150 movably couples with the second basis member or end 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both expanding member 150 and second basis member 120 are rotatably blocked though rotation retainer elements.
- An external tool 300 having pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the extension member 150. This can result in a displacement of the expanding member 150 relative to the rotating member 140, thus an increase of the total height or thickness of the device body 105.
- the second rotating 140 can rotating while the expanding member 150 is longitudinally translating. The rotation of the rotating member 140 can be locked through a pin, a screw, a clip, or a more complex piece.
- the implantable joint replacement device 100 can include an expandable device body 105 that can include a first end or member 110 and a second basis end or member 120.
- the first member 110 can act as a deformable member and can be coupled with an extension member 150 or the first member 110 can act as both a deformable and extension member.
- the second member 120 can be rotatably coupled with a rotating member 140.
- the expanding member e.g., 110 or 150
- the expanding member 140 can move longitudinally (axially) relative to the rotating member 140 and second member 120, and the rotating member 140 can rotate relative to the first and second members 110 and 120 and the expanding member (e.g., 110 or 150).
- the expanding member 150 can include a plurality of corrugations 220 at the outer surface
- the rotating member 140 can include a plurality of corrugations 210 at the internal surface.
- the plurality of corrugations 220 can engage with the plurality of corrugations 210 to movably couple the members 140 and 150.
- the expandable device body 105 of the implantable joint replacement device 100 can include one first end or member 110 being coupled with one expanding member 150, in which the expanding member 150 can be a member distinct from the deformable member and first end 110.
- This expanding member 150 can have a plurality of corrugations 220, such as ACME type threads, at the outer surface.
- the expandable device body 105 of implantable joint replacement device 100 can include a second end 120 that is rotatably coupled with a rotating member 140.
- This rotating member 140 can include a circular gear rack 230 at a part of the outer surface and a plurality of corrugations 210, such as bevel threads, at the internal surface.
- the circular gear rack 230 at the outer surface can include a plurality of grooves.
- the expanding member 150 movably couples with the second end 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both extension member 150 and second end or member 120 are rotatably blocked though rotation retainer elements.
- the rotating member 140 is rotatably coupled with the second member 120 through multiple dowel pins 170 that are installed peripherally through holes 121 in the second end 120 into a peripheral groove 141 on the member 140.
- An external tool 300 having pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the rotating member 140 to activate a rotation of the rotating member 140.
- the rotating member 140 being rotatably coupled with the second end or member 120, and through the pluralities of corrugations 210 and 220 that can be engaged, the rotation of rotating member 140 can lead to the longitudinal moving of the extension member 150 in and relative to the second end 120.
- the longitudinal moving of the expanding member 150 can cause the longitudinal moving of the first end 110 since they are coupled together. Therefore, a longitudinal (axial) displacement of the expanding member 150 relative to the rotating member 140 can result, in a longitudinal (axial) direction of the first member 110 relative to the second end 120, thus leading to an increase or a decrease of the total height or thickness of the expandable device body 105.
- the rotation of the rotating member 140 can be locked through a pin, a screw, a clip, or a more complex piece.
- the first member 110 and the expanding member 150 can be fused together (and numbered 110), therefore the plurality of corrugations or threads 220 can be at the external surface portion of the first member 110.
- the new first member 110 can be movably coupled with the rotating member 140 by the pluralities of corrugations or threads 210 and 220 on the first member 110 and rotating member 140.
- the longitudinal (axial) movement of the first end 110 can be activated by the rotation of the member 140 through the action of the external tool 300 and the geared end 310 on the external gear rack 230 of the rotating member 140. This leads to a longitudinal movement of the first member 110 relative to the second end or member 120 and by a change in height or thickness of the expandable device body 105.
- the first member 110 or expanding member 150 can be rotatably stopped within the second end or member 120 through rotation retainer guides, such as longitudinal tenon and mortise or pine and gutter, incorporated in the second member 120.
- the rotating member 140 can be rotatably coupled with the second member 120, the rotating member 140 being embedded within the second member 120. It can be done by welding, screwing or by using dowel pins. In some examples, the rotating member 140 is set within the second member 120, said second member or end 120 having two parts being assembled and coupled over the rotating member 140. In some examples, the rotating member 140 is coupled to the second member or end 120 through dowel pins disposed peripherally on the second member 120 into a bevel in the rotating member 140. Therefore, in some examples, the rotating member 140 can rotate around the longitudinal axis 200 of the expandable device body 105 and may not translate relative to the second member 120 along the longitudinal axis of the expandable device body 105.
- the pluralities of corrugations 210 and 220 can be engaged together and can convert the rotation of the rotating member 140 into an axial translation of the member or end 120, and consequently into the expansion of the height of thickness of the expandable device body 105.
- This conversion may be performed under a load stress applied onto the expandable device body 105 and the members by the first joint replacement device component of the implantable prosthetic joint replacement device 100. Therefore, this mechanical conversion or transmission may use an effort to counteract the mechanical friction occurring within the engaged corrugations 210 and 220 under the load applied onto the expandable device body 105.
- the corrugations 210 and 220 can be of various types, can have various geometries or shapes and various angles, and can include threads including, standard threads, V threads, ACME threads, worm, square, buttress, knuckle or Whitworth threads, and the like.
- the expandable device body 105 can allow for an external tool 300 to temporarily couple through the expandable device body 105 with one or more member(s) within the expandable device body 105.
- the external tool 300 can connect with the member 150 of the expandable device 105, or it can connect with the rotating member 140 of the expandable device 105.
- the external tool 300 can connect with both members 140 and 150 of the expandable device body 105.
- the external tool 300 includes a connecting end 305 to connect with the member 140 or 150.
- one part of the expandable device body 105 can include a slot, hole, aperture, or other similar component to let the external tool 300 connect with the member 140 or 150.
- the expanding member 150 in the expandable device body 105 can include a first gear 230 that can be engaged by a second gear 310 at the connecting end 305 of the external tool 300.
- the support 140 of the expandable device body 105 can include a first gear 230 that can be engaged by a second gear 310 at the connecting end 305 of the external tool 300.
- the first and second gears (230 and 310) can engage according to rack and pinion, where the second gear 310 is a pinion.
- this rack and pinion can be linear or circular. In some examples, this rack and pinion is linear and longitudinally oriented.
- the first gear 230 may be another type of gear, such as a worm gear, bevel gear, screw gear, helical gear, or the like.
- the second gear 310 can include various types of gear including, but not limited to, pinion, bevel gear, helical gear, screw gear, etc.
- the movement of one member or end, such as the expanding member 150 or first member 110, relative to the other member or end such as the rotating member 140 or second member or end 120, can be locked by different features.
- the rotating member 140 can control and stop the movement of the expanding member 150 through the engagement of a plurality of corrugations 210 on the rotating member 140 with the plurality of corrugations 220 of the expanding member 150.
- the extension member 150 being movably coupled to the rotating member 140, the axial movement of the expanding member 150 can be blocked by immobilizing the rotation of the rotating member 140.
- the rotating member 140 can be rotatably stopped with the use of a screw or pin that will block the member 140 and avoid driving of the longitudinal movement of the expanding member 150.
- Different locking systems can be installed to block the motion of either the member 140 or 150, or to avoid the transfer of motion (rotation to translation) between the members 140 and 150.
- an external cover member 160 can couple with one member or end of the expandable device body 105.
- the external cover member 160 can correspond in shape with the expandable device body 105 and the members or ends (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.).
- the external cover member 160 can act as an outer skirt and cover the peripheral area of the device body 105 without disabling the connection of the external tool 300 with the members 140 or 150.
- the external cover member 160 can be made of many materials including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- the external cover member 160 can be coupled with a member or end of the expandable device body 105 through welding, sticking, screwing, or pining, and the like. In some examples, there may be no external cover member 160 in the expandable device body 105 of the implantable joint replacement device 100. This external cover member 160 may have no impact nor effect on the relative movement of the members and ends in the expandable device body 105.
- the expandable device body 105 of the implantable joint replacement device 100 can include a first member 110, an expanding and deformable member including features of the first member (110) and the expanding member (150).
- This merged first member 110 (110+150) can include the same grail or chalice shape with the upper bowl portion 113, rim 111, short stem 112, and the lower foot/base 114 with a lower surface 115.
- the lower foot/base 114 can include the plurality of corrugations or threads 220 at the external surface.
- the plurality of corrugations or threads 220 at the external portion of the foot/base 114 can include flat nerves 117, that are located peripherally, to engage with rotating retainer guides that are disposed at the lower surface inside the second member 120.
- the rotating retainer guides in the second member 120 can engage within the flat nerves 117 of the first member 110 and disable rotation of the first member 110 in the second member 120 while allowing a relative longitudinal movement of the first member 110 from the second member 120.
- some ribs or nerves 116 may be present at the lower surface 115, thus giving not a flat lower surface 115 but a multi-stage lower surface 115.
- FIG. 7B shows how the expandable device body 105 of the implantable joint replacement device 100 can be configured to expand or reduce the height of the expandable device body 105.
- the external tool 300 and the pinion-like end can engage with the member 140 and the external rack of gear teeth.
- the rotating of the external tool 300 can train a rotation of the rotating member 140 in B (FIG. 7B), and since the rotating member 140 is thread-engaged with the expanding member 110, it can train an axial movement of the expanding member 110 and the cup 104 in C.
- C FIG.
- the expanding member 110 and the cup 104 can translate relative to the basis member 120 within a range from 0 to 10 millimeters, or from 0 to 6 millimeters, or within another range.
- the height of the expandable device body 105 of the implantable joint replacement device 100 can be expanded within a range from 0 to 10 millimeters, or from 0 to 6 millimeters, or within another range.
- the expandable device body 105 of the implantable joint replacement device 100 can be lockable.
- the modular components constitutive of the expandable device body 105 can be lockable to avoid unexpected displacements, and micromotions and micromovements between the modular components once installed in the body joint.
- modular designs or multi-component devices might allow small levels of undesirable motion, so called micromotion, between the components that should stay firmly locked together after the device is assembled and installed.
- Micromotions may be an undesirable source of wear that can lower the useful life and endurance of modular implants or degrade the stability of implants over time or increase corrosion.
- Locking can eliminate or control undesired movements and micromotions in such multi-component devices. Moreover, it can eliminate movements that may lead to the de-adjusting of the device and an undesired change in physical metrics, such as, for example, a change of the device height.
- a locking system and element can be incorporated to locked together the components and members of the expandable device body 105 such as the members 110, 120, 140 and 150.
- this locking can be achieved through locking screw(s) or pin(s) or a combination of a piece and a screw or equivalent system.
- a set screw can be used to lock some of the members such as a rotating member (e.g., 140) in the expandable device body 105 (see FIG. 7C).
- the rotating member 140 can act as a locking member for the adjustable mechanism in the expandable device body 105.
- FIG. 7C and FIG. 7D show expandable device bodies 105 that incorporate locking system and elements in addition to the adjusting mechanism and elements.
- the expandable device body 105 can include the members 110, 120, 140 and 150 for the adjusting mechanism and can incorporate additional members to allow the physical locking of this adjusting mechanism.
- a variety of locking principles and elements can be applied to the adjusting mechanism of the expandable device body 105, including a partial to complete locking from the locking of the external action to the full locking of the adjusting mechanism itself. For instance, self-locking members, wedging members, flex members, locking clips/rings or other locking elements can be used.
- the adjusting mechanism in the expandable device body 105 can be locked by externally blocking the rotation of the ring member 140.
- a pinion-like piece 311 can be externally engaged and fixed using a screw 312 to eliminate rotating of the member 140 through the external tool 300.
- This type of locking is partial blocking the external access and action onto the adjusting mechanism in the expandable device body 105 while not fully mechanically lock the adjusting mechanism itself.
- Elements that can be applied to block the action or movement of the ring member 140 include locking clips, pins, screws and the like.
- an additional member 180 incorporated in the expandable device body 105 can act as a locking member to lock the adjusting mechanism when the height of the expandable device body 105 is adjusted.
- a second external locking tool 350 may be provided to engage with and action the locking nut 180 to lock the mechanism within the expandable device body 105.
- the locking of the system in the expandable device body 105 can be reached through the locking member 180 by acting on deformable flex parts in the expandable device body 105: in D.l, the locking member 180 can use the ring member 140 which has flex walls 151 in the lower part; in D.l, the locking member 180 can engage the ring member 140 to use small flex pallets 121 in the humeral base 120.
- these flex elements 151 or 121 being disposed circumferentially can deform radially and squeeze onto the expandable member 110, thus blocking the height movement in the expandable device body 105.
- an external tool 300 can be used to action the adjusting mechanism of the expandable device body 105, and another external tool 350 can be used to action the locking of the expandable device body 105.
- the external tools 300 and 350 can be distinct or can be combined in one single external tool.
- the first member 110 can have one or multiple channels, apertures, windows, and the like, at or close to the central axis 200 of the first member 110, going through the first member 110 from the lower surface 115 to the upper concave surface 125 that receives the socket or cup 104.
- the upper surface 125 of the first member 110 can incorporate a groove, an open gutter, channel or laugh, going to the periphery of the first member 110 from the central axis region of the first member 110. This groove at the surface 125 can join an axial aperture emerging at the central portion of the first member 110 up to the side of the surface 125 and first member 110.
- FIG. 7E shows another example of the expandable device body 105 incorporating a locking system.
- the expandable body 105 can support an articulating cup 104.
- the expandable body 105 can include the members 110, 120, 140, 150 and 180 for an adjusting mechanism.
- the first member 110 can be also built from two parts 110 and 150.
- the two parts 110 and 150 may be immovably and ultimately definitively coupled to each other.
- the second member 120 can be built from two parts (120 and 125).
- the two parts 120 and 125 can be immovably and ultimately definitively coupled to each other.
- the second member 120 rotatably embeds or includes the member 140 and 180.
- the locking principle may be based on the nut and locknut mechanism formed by members 140 and 180.
- the adjusting and locking mechanisms can be actioned externally by external tools 300 (adjusting) and 350 (locking). These external tools can be independent or can be combined partly or totally.
- the adjusting tool 300 can drive the member 140 via a pinion-like end 310 that engages with the gears 230 of the member 140.
- the locking tool 350 can drive the member 180 via a pinion-like end 360 that engages with the gears 240 of the member 180.
- These members 300 (adjusting) and 350 (locking) external tools can be manual or powered.
- An opening 122 in the member 120 (120 + 125) may enable the external tools 300 and 350 to drive the members 140 and 180.
- the member 110 (110 and 150) can be coupled movably with the members 140 and 180 via the plurality of threads 220, at the outer part of the member 150, that are engaged to the plurality of threads 210 inside the member ring 140 and to the plurality of threads 215 inside the locking member 180.
- the first member 110 can incorporate an internal empty chamber volume 400 at the foot/base portion 114.
- This internal empty chamber volume 400, or internal module 400 can be mainly shaped cylindrical as an open recess at the lower part of the first member 110 and can be defined by the lower surface 115 and the wall surface 118 from the first member 110.
- This open chamber or internal module 400 can be closed by using a cap or cover 410.
- This cap or cover 410 can be made of the same material than for the first member 110, including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- the internal module 400 within the first end 110 can be hermetically closed with the cap or cover 410 to form a sealed enclosure to avoid ingress of fluids or solid particulates. This can be reached by welding, gluing or mechanically using a ring or seal between the cover 410 and the first member 110.
- the hermetic internal module 410 can maintain internally quite a dry environment, such as at a moisture level lower than 5000-7000 ppm.
- the implantable joint replacement device 100 can incorporate various components that can detect various metrics, parameters, or characteristics.
- the implantable joint replacement device 100 can include at least one component to detect one physical metric or multiple physical metrics related to the implantable joint replacement device 100, or a portion thereof, or occurring proximate to the first member 110 of the expandable device body 105.
- the first member 110 can include an expanding and deformable member having a bowl portion 113 that supports and withstands the mechanical loads that are applied by the first joint replacement device component onto the socket or liner 104 and to the first member or end 110. Due to the specific grail/chalice shape, the mechanical loads applied onto the first member 110 and the bowl portion 113 can translate into micro-deformations that can be detected at the lower surface 115.
- a contact load applied onto the expanding and deformable member 110 can be determined through the micro-deformations that are generated and can be detected at the lower surface 115 of the lower foot/base 114. For example, detecting the microdeformations can be generated by the contact load applied onto the first member 110 to install one or a plurality of sensors at/on the lower surface 115 of the expanding and deformable member 110.
- a plurality of sensors 600 can be coupled onto the lower surface 115 of the member 110. It can be one sensor or a group of three or more sensors 600, to reach the adequate accuracy.
- Each of the sensors 600 can be coupled onto the lower surface 115 such that the sensors 600 are circumferentially positioned about the central axis 200.
- Each of the sensors 600 can be spaced an equal distance apart from one another circumferentially surrounding the central axis 200.
- the sensor 600 can circumferentially surround an annular portion of the first member 110 to facilitate detecting an amplitude and direction of a load force placed on the upper portion of the member 110 of the expandable device body 105.
- the joint implant device 100 can include a set with more than three sensors 600.
- the sensors 600 can be selected among various types of sensors including, but not limited to, strain gauges, bonded and unbonded strain gauges, fine wire strain gauges, thin foil strain gauges, semiconductor strain gauges, photoelectric strain gauges, resistive sensors, piezoelectric / piezoresistive sensors, capacitive sensors, and the like.
- strain gauges that are devices to measure strain on an object can be used for the sensors 600. As an object is deformed, the foils of strain gauges are deformed causing the electrical resistance to change that can be related to the strain, and therefore to the stress or load.
- the sensors 600 can measure a signal related to and corresponding to a load or force, a pressure, a temperature, a relative humidity, a deformation, a distance, length or movement, a load position or orientation, or other similar physical metrics, and any combination thereof.
- the sensor 600 can be coupled to the lower surface 115 of the first member 110, and for example can be adhered onto the surface 115 by using bond, glue or adhesive.
- the adhesive, bond or glue can be coldcuring or fast-curing materials selected among methacrylate, cyanoacrylates, acrylates, epoxy resins, phenolic resins, and the like.
- three sensors 600 can be glued peripherally at the lower surface 115, being positioned at 120° angulation around the central axis 200.
- three sensors 600 can be glued peripherally as previously described and one sensor 600 can be glued centrally at the axis position 200.
- circuitry and connections 601 that couple with the set or group of sensors 600 can be added at/to the lower surface 115.
- the sensors 600 and circuitry 601 being installed onto the lower surface 115 of the first member 110 are enclosed within the internal module 400 of the first member 110. Therefore, the sensors 600 and circuitry 601 can be protected within a sealed hermetic internal module 400 of the expanding member 110.
- the accuracy and reproducibility for the measurements of the load magnitude and center of load position may be dependent on the quality of the assembly and the characterization of the deformable member 110 and the group of sensors 600.
- the type and number of sensors coupled to the deformable member 110 of the expandable device body 105 may change depending upon the resolution and the desired amount of data. Additional sensors (three, four, five, six, or more sensors) may be used to collect enough data points and to allow for calculation and determination of parameters such as the load magnitude and center of load position. In some instances, the detection and determination of the load magnitude and center of load position applied onto the upper guiding surface 125 of the deformable member or end 110 through the cup or socket 104 can be based on the microdeformations created by the load applied on upper guiding surface 125 of the deformable member or end 110 at the lower surface 115 of the deformable member or end 110.
- strain gauges can be the selected sensors for the lower surface 115 of the deformable member 110: in a resistive and also other circuits of strain gauges, a tension causes a resistance increase, and a compression causes a resistance decrease.
- a bridge circuit of strain gauges such as a quarter-bridge, half-bridge, fullbridge, can be installed at the lower surface 115 of the deformable member 110 to detect the load magnitude and center of load position.
- the internal module 400 in the first member 110 can include a variety of components 420, including electronic or electrical components, such as, for example, circuitry, rigid of flexible boards, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components.
- These components 420 can communicably couple the internal module 400 in the first member 110 of the expandable device body 105 with an external module 500.
- the external module 500 can be non-implanted and exterior to the implantable joint replacement device 100 and to the body of a patient (FIG. 10).
- the components 420 can be operatively coupled to each other through various connections, welds, wires, cables, pins, or by direct contact.
- Such components 420 can include Printed Circuit Boards (PCB), such as sensor PCB (425) and operational PCBs (435), and internal power source such as a battery (430).
- PCB components (425, 435) can be selected among single-layer, double-layer or multilayer PCBs.
- the internal module or chamber 400 can also enclose an antenna 450 for the communication and data transmission.
- the sensor(s) 600 and additional sensor(s) 610 can be enclosed within the internal module 400.
- some elements working with or related to the sensor(s) 610 can be located inside the expandable device body 105 and outside the internal module 400.
- one or several magnetometers can be included within the internal module 400 and a magnet to work with the magnetometer can be coupled with the second member or another part of the main external device body.
- the physical disposition of the components 420, such as the PCBs (425, 435), the battery 430 and antenna 450, within the internal module 400 can be various as shown in FIG. 8B (B.l, B.2, B.3 and B.4).
- one battery or several batteries can be assembled directly onto one PCB inside the internal module 400.
- the internal module 400 and the components 420 can be active and incorporate a power source and related connectors, such as a rechargeable battery, a changeable or removable battery, and the like (430).
- the battery 430 can be a non-rechargeable and non-changeable battery.
- the battery 430 can be a lithium or lithium-ion battery, such as a lithium iodine battery, lithium carbon monofluoride or lithium polycarbon fluoride battery and the like, and it can be a solid state battery.
- the battery 430 can include multiple battery units.
- the battery within the internal module 400 can be recharged without opening the internal module 400, such as by wireless power transfer.
- the internal power source can be used to help powering or to fully power the electronic system and components within internal module 400 of the first member 110.
- the internal module 400 can include a plurality of electronic components and other subcomponents that cooperate to detect the load, length or height and other characteristics and performance data and transmit the detected or measured data to an external module 500.
- the internal module 400 may include electronic circuit boards, Printed Circuit Board (PCB), multichip modules (MCM), or flex circuit boards including microprocessor, communication module, power supply, and one or more sensors.
- the internal module 400 may be configured to provide both integrated, space-efficient electronic packaging and mechanical support for the various electrical components and subsystems of the internal module 400.
- the listing of components of the internal module 400 is exemplary only and not intended to be limiting. In the example shown in FIG.
- the internal module 400 includes at least one Printed Circuit Board (PCB) which supports elements such as a power management element, a microcontroller element, a wireless communication interface and an analog-to-digital converter (ADC).
- PCB Printed Circuit Board
- This PCB can also support the previously described additional sensors 610.
- hermetic feedthrough connector to connect with components exterior to the internal module 400.
- the hermetic feedthrough connector enables communicably coupling with the exterior of the internal module 400 and avoids ingress or entrance of fluid, humidity or particulates in the internal module 400.
- the expandable device body 105 can incorporate at least one additional sensor 610 where the additional sensor 610 can be independent from the sensor or group of sensors 600.
- the additional sensor 610 can detect or measure a physical metric, such as a temperature, a relative humidity, a pressure, a distance or displacement, a force, a vibration, a force position, or other similar physical metrics, occurring in a portion of the expandable device body 105.
- the sensor 610 can be one or more of a magnetometer, accelerometer, LDC (inductive-to-digital converter) based sensors, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, strain gauge, or the like.
- the expandable device body 105 can include a contact-less sensor system as the additional sensor 610, located within the internal module 400 of the first member 110, to measure the unidirectional or axial change in distance between the first member 110 and the second member 120. This may allow the system to determine the height of the expandable device body 105 and the change of the body 105.
- the additional sensor 610 can be a contact-less sensor system having a magnetometer, an inductive-to-digital converter (LDC), or any other contact-less sensing element.
- the contact-less sensor system can be assembled onto the PCB (425, 435).
- the contact-less sensor system can have an inductor component located within the internal module 400.
- one or several magnetometers 610 can be coupled with a portion of the expandable device body 105 such as in the internal module 400 of the first member 110, to act as a position sensor.
- the sensor 610 can measure a position or a motion of the first member 110 or can measure the relative displacement of the first member 110 to the second end or member 120, thus providing a value of the height, length or thickness of the expandable device body 105.
- a temperature and/or relative humidity sensor 610 can be additionally coupled within a portion of the expandable device body 105.
- the sensor 610 as for the sensors 600, can be located within the internal module 400 of the first member 110.
- the additional sensor 610 can be coupled with the surface 115 or can be supported through or by an electronic component, such as a board or a Printed Circuit Board (PCB) and located within the internal module 400 of the first member 110.
- PCB Printed Circuit Board
- the expandable device body 105, the internal module 400 and the components can be activated/deactivated, started/stopped through an internal magnetic sensitive switch such as a reed switch, hall effect switch, and triac or transistor switch.
- the start/stop or activation/deactivation is performed through the proximity detection of a magnet located in a portable handheld activation system.
- the magnetic sensitive switch and a logic circuitry enables to connect/disconnect the power source and the electronic circuitry inside the internal module 400.
- the start/stop or activation/deactivation of can be controlled by the magnetic sensitive switch and may use the simultaneous wireless detection of and connection to an external device such as the external module 500.
- the expandable device body 105 and the internal module 400 can be communicably coupled with the external module 500.
- the mode of communication between the internal module 400 and the external module 500 can be wireless.
- Modes of wireless communication can be radiocommunication, radiofrequency communication, mobile communication, infrared communication, microwave communication, Wi-Fi communication and Bluetooth communication.
- the modes of wireless communication for electronic implants can be selected among near-field radiofrequency, fairfield radiofrequency, mid-field radiofrequency, electromagnetic, ultrasound and photovoltaic.
- MICS or Medical Implant Communication System as a short-range communication technology can be used for wireless communication and transmission, operating at 401-406, 413-419, 426- 432, 438-444, and 451-457 MHz frequency ranges.
- Wireless communication frequency range such as 9-315 kHz, 125 kHz-13.56 MHz, 860-960 MHz, 2,45-5.8 GHz, and the like, can be used as they are for implantable medical devices such as implantable pacemakers, defibrillators, neurostimulators, etc.
- Any wireless communication frequency ranges in the various countries that could be or become available and acceptable for medical devices and implantable medical devices such as the implantable joint replacement device 100 of the present disclosure could be selected for the wireless communication and transmission between the internal module 400 and the external module 500.
- Wireless communication and connectivity can be provided through protocols such as WiFi, Bluetooth (Bluetooth LE), Near-Field Communications (NFC), MICS, and the like.
- the external module 500 may include an active component that can incorporate an internal power source, such as a rechargeable battery, a changeable or removable battery, and the like, and/or can also incorporate a power connector to plug with the mains. It can also be powered by connection with another external active device.
- an internal power source such as a rechargeable battery, a changeable or removable battery, and the like
- the expandable device body 105 of the implantable joint replacement device 100, and the components such as the internal module 400, are coupled communicatively, and wirelessly, with the external module 500, and the external module 500 is coupled communicatively, and wirelessly, with a computing device 1010.
- the expandable device body 105 of the implantable joint replacement device 100 can incorporate an antenna 450 to enable wireless communication and transmission between the internal module 400 and the external module 500.
- the antenna 450 can be enclosed within the internal module 400 of the first member 110.
- the antenna 450 may be outside the internal module 400, and outside the first member 110 and still coupled to a portion of the device body 105.
- the antenna 450 may be coupled at an outer portion of the expandable device body 105, for instance through the outer surface of the external cover member 160.
- the antenna 450 can be of the second member or end 120.
- the antenna 450 can be a flexible antenna, a flexible PCB antenna, that may conform circumferentially to an external surface part of a member of the expandable device body 105.
- the antenna 450 may be affixed-coated or embedded within the external cover member 160.
- the antenna 450 can be communicably coupled, e.g., in a wired way, with components of the internal module 400.
- the antenna 450 may be enclosed, cast, affixed-coated, or embedded at the upper surface 125 of the member 110 such as in polymer, epoxy, peek, ceramic and the like.
- Such wiring can go from the antenna 450 through the member(s) in the body 105 and through the first member 110 to the inside of the internal module 400 without impairing the hermeticity of the sealed internal module 400, for instance through a feedthrough connector 126 disposed an internal window in the first member 110.
- the antenna 450 can be selected among several types of antennas such as loop antennas, halo antennas, chip antennas, monopole antennas, and the like, and can support various wireless communication protocols (MICS 405 MHz, Bluetooth Low Energy 2.4 GHz, LoRA/Wi- SUN and other sub-GHz protocols 868-915 MHz).
- an implantable prosthetic joint replacement device having multiple joint replacement device components and comprising one expandable joint replacement device body receiving a first joint replacement device component and being coupled with a second stemmed joint replacement device component, wherein the device body comprises one expanding member, and wherein the said expanding member supports an articulating piece to contact with the second joint replacement device component, can expand axially related to another member of the device body to expand or diminish the total height of the device body, within a range from 0 to 10 millimeters (or another range, such as 0 to 6 millimeters), and incorporates a plurality of sensors to detect or measure at least one physical metric applied onto or related to the expanding member and/or device body.
- the device body comprises an expanding member and other members including one rotating member and one basis member, wherein the basis member is coupled with the second stemmed joint replacement device component, and the rotating member is coupled, but remaining rotatably free, with the basis member of the expandable device body.
- the expanding member is engaged with the rotating member, such as a screw and a bolt, through a plurality of corrugations or threads, with a plurality of corrugations or threads at the external portion of the expanding member and another plurality of corrugations or threads at the internal surface of the rotating member.
- the rotating member additionally comprises at the outer circumferential portion a rack with a plurality of gear teeth, and this rack with a plurality of gear teeth can be activated or actioned to rotatably train the said rotating member.
- the rotating and expanding members are engaged as screw and bolt, the rotation of the rotating member will train an axial movement of the expanding member relative to the rotating and basis members.
- the rotating member and the rack with a plurality of gear teeth can be actioned by the use of an external tool having a pinion gear-like end to engage with the gear teeth.
- the expanding member can also comprise two separate elements that are integrally coupled together. One element of the expanding member presents at the outer circumferential portion a rack with a plurality of gear teeth, where the rack and plurality of gear teeth can be actioned or activated by engaging with a pinion gear-like end of an external tool, which results in the axial movement of the expanding member relative to the basis member.
- the expanding member additionally incorporates a closed internal module.
- the plurality of sensors is coupled to a lower surface inside the closed internal module of the expanding member to withstand micro-deformations and to detect load magnitude and orientation.
- This closed internal module also comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components.
- an antenna can be coupled to the expandable device body but located outside the closed internal module, and this antenna is communicably coupled with the electronic components inside the closed internal module.
- the closed internal module is communicably coupled with an external module or hardware, for instance through the antenna. Inside the internal module, sensors are communicably coupled to the electronic components and circuitry.
- the sensors can be selected among accelerometer, magnetometer, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, piezoresistive sensor, strain gauge sensors, and can include thin foil and semiconductor strain gauge sensors.
- the sensors measure or detect a physical metric selected among deformation, load or force, position, distance or length, displacement, temperature and/or humidity.
- the component devices, the members and parts of the expandable device body are composed of materials that can be selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- the implantable prosthetic joint replacement device can be used to replace a ball-and- socket (spheroid) joint of a human or mammalian body, and can include a hip arthroplasty device or shoulder arthroplasty device. Therefore, the second joint replacement device component can comprise a ball or sphere, and the implantable prosthetic joint replacement device can include a reverse total shoulder arthroplasty device with a first glenosphere component and a second proximal humeral component. [00099] An implantable reverse shoulder arthroplasty device is proposed having a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component.
- the expandable proximal humeral body comprises an expanding member to support a humeral liner to receive the glenosphere component, and a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member.
- This rotating member presents at the outer circumferential portion a rack with a plurality of gear teeth and the rotating member can be rotated by the action an external tool having a pinion-like end on the rack and gear teeth.
- the rotating member trains the expanding member to move axially and to increase or diminish the height of the expandable proximal humeral body.
- the expandable proximal humeral body also incorporates a plurality of sensors coupled with a surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner.
- the rotating member comprises a plurality of threads at the internal surface, and a rack with a plurality of gear teeth at a circumferential portion of the external surface.
- the expanding member comprises a plurality of threads at a lower portion of the external surface.
- the closed internal module comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, transponders, tags, resistors, capacitors, communication units, memory units, antenna, or other similar components.
- the expandable proximal humeral body comprises additionally an antenna outside the closed internal module, and the external antenna is communicably coupled with the electronic components inside the closed internal module.
- This closed internal module is communicably coupled with an external module or hardware.
- These sensors are communicably coupled to electronic components and circuitry in the closed internal module.
- sensors are selected among accelerometer, magnetometer, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, piezoresistive sensor, strain gauge sensors, and can include thin foil and semiconductor strain gauge sensors.
- the measured or detected physical metric can be selected among deformation, load or force magnitude and position, distance or length, displacement, temperature and/or humidity.
- the load magnitude and center of load position can be some of the physical metrics along with the displacement between the members of the expandable proximal humeral body.
- the members of the expandable proximal humeral body and the reverse total shoulder arthroplasty device components can be composed of materials selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- FIG. 9 and FIG. 10 shows an illustration of an exemplary joint replacement system 1000 for the detection, measuring and recording of loads and other physical metrics present in the body joint and in the joint replacement device 100.
- the joint replacement system 1000 can include a system for intra-operative and post-surgery measuring, determining, recording, in realtime or near real-time, and analyzing performance characteristics and parameters at an implanted prosthetic joint replacement device.
- the performance characteristics and parameters may include anatomical, kinetic, kinematic or biomechanical characteristics and parameters that may be used to evaluate the behavior or performance of a prosthetic joint replacement implant.
- performance parameters include information indicative of contact load, pressure, angle of flexion and/or extension, torque, angle of abduction and/or adduction, center of load position, angle of internal/ external rotation, range of motion, implant laterization/medialization, and the like. These are non-limiting examples.
- Embodiments consistent with the disclosed systems and methods may be employed in arthroplasty and joint replacement procedures related to ball-and-socket joints, such as the hip and shoulder. Furthermore, certain elements consistent with the presently disclosed systems and methods may be used intra-operatively and post-surgery.
- an external module 500 communicably couples with the internal module 400, the enclosed electronic components 420 and sensors 600 and 610, in the expandable device body 105 of the implantable joint replacement device 100.
- the external module 500 can be an independent handheld device, or hardware, totally external and independent from the patient’s body, or can be a patch, reinforcement, or the like, that adheres to or is coupled with a portion of a patient’s body (e.g., limb).
- the external module 500 can be a handheld external module 500.
- the external module 500 can incorporate a power source, such as a battery, a rechargeable, changeable or removable battery, and the like.
- the external module 500 can be powered through an external source, such as mains, or through a computing device, such as a computer or laptop.
- the external module 500 can receive and analyze the signal from the internal module 400.
- the external module 500 can determine, based on the analyzed signal received from the internal module 400, data corresponding to physical metrics applied onto the implantable joint replacement device 100.
- the external module 500 can communicably couple to one or more computing devices 1010 to transmit data measured by sensors in the expandable device body 105 of the implantable joint replacement device 100, including data corresponding to the contact load force, the height or thickness of the device body 105, the position of the expandable device body 105 (e.g., within a joint), or orientation in space of the implantable joint replacement device 100.
- an example of an implantable joint replacement system 1000 can include an implantable joint replacement device 100, including the internal module 400, one external module 500, one or multiple external indicators 700, a computing device 1010 with a data processing system 1015 and an access to a network 1050
- the implantable joint replacement system 1000 can be for a reverse shoulder joint replacement device 100, with the joint replacement device 100 including the bone screws 103, the baseplate 106 and glenosphere 101, the humeral cup 104 and the humeral tray or body 105, and the humeral stem 102.
- the joint replacement system 1000 can facilitate evaluating the joint replacement device 100 through the device body 105.
- the joint replacement device 100 of the joint replacement system 1000 includes the internal module 400 inside the device body 105.
- the internal module 400 can include the one or more sensors 600 and 610 described herein and can transmit signals to and can receive signals from another portion of the joint replacement system 1000, such as to the external module 500.
- the external module 500 can transmit signals to and can receive signals from the internal module 400.
- the external module 500 can include one or more transceivers or transmitters to transmit a signal from the external module 500 to the internal module 400.
- the external module 500 can include one or more frequency generators such that the external module 500 can transmit radio frequency signals (e.g., oscillations, electromagnetic waves, vibrations, etc.) in multiple directions.
- the radio signals can reflect off or be absorbed by one or more components of the joint replacement device 100 to create a radio frequency feedback loop between the external module 500 and the internal module 400.
- One or more components of the internal module 400 can receive one or more signals from the external module 500.
- the sensor(s) 600 can detect a load on the joint replacement device 100 and can be installed to measure the load magnitude and center of load position for the contact load force applied onto the expandable device body 105 and first member 110.
- the internal module 400 can detect a change or fluctuation of the sensor(s) 600 and can adjust or change one or more properties of a radio frequency loop between the external module 500 and the internal module 400, which can create a change in a reflected signal from the internal module 400 to the external module 500.
- the external module 500 can receive a signal (e.g., data packet, an indication, etc.) from the internal module 400.
- the external module 500 can receive a reflected radio frequency signal from the internal module 400 in response to the transmitted signal from the external module 500.
- the external module 500 can transmit power to the internal module 400, such as by wireless power transfer, for example by near field or non-radiative techniques or by far field or radiative techniques. Such techniques may be selected among inductive coupling, resonant inductive coupling, capacitive coupling, magneto-dynamic coupling, microwaves, and light waves.
- the external module 500 can include a self-standing self-powered hardware that communicates (wirelessly) measured data to the computing device 1010 and data processing system 1015.
- the external module 500 can be powered externally and have a wired communication with the computing device 1010 and data processing system 1015 of the joint replacement system 1000.
- the external module 500 can be a standalone handheld battery- powered transceiver hardware that both communicate, receive and transmit wirelessly signals and data from the internal module 400 of the implantable joint replacement device 100 to the computing device 1010 and data processing system 1015.
- the external module 500 may not include a transceiver hardware that is wired to and powered by the computing device 1010 to both communicate, receive and transmit signals and data from the internal module 400 of the implantable joint replacement device 100 to the computing device 1010 and data processing system 1015.
- the external module can include a wireless communication transceiver 500 may include any device suitable for supporting wireless communication between one or more components of joint replacement system 1000.
- the wireless communication transceiver may be configured for operation according to any number of suitable protocols for supporting wireless, such as, for example, wireless USB, ZigBee, Bluetooth, Wi-Fi, or any other suitable wireless communication protocol or standard.
- the wireless communication transceiver of the external module 500 may embody a standalone communication module, separate from the computing device.
- the external module or wireless communication transceiver 500 may be electrically coupled to the computing device 1010 via USB or other data communication link and configured to deliver data received therein to the computing device 1010 for further analysis.
- the external module and wireless communication transceiver 500 may include an integrated wireless transceiver chipset, such as the Bluetooth, Wi-Fi, NFC, or 802.1 lx wireless chipset.
- the joint replacement system 1000 can include at least one computing device 1010 that can support and/or communicably couple with at least one data processing system 1015.
- the computing device 1010 and data processing system 1015 can include several components or engines.
- the computing device 1010 and data processing system 1015 can include components or engines to transmit or receive data from one or more remote sources (such as the computing devices 1010, the external module 500, or the internal module 400, and other external sources).
- communications device(s) may access the network 1050 to exchange data with various other communications device(s) via cellular access, a modem, broadband, Wi-Fi, satellite access, etc. via the data processing system 1015.
- the computing device 1010 may be any device(s), component(s), circuit(s), or other combination of hardware components designed or implemented to receive inputs or other signals for evaluating the joint replacement device 100.
- the computing device 1010 and data processing system 1015 can receive inputs or other signals for evaluating the joint replacement device 100 when the device 100 is being used within a joint, such as a shoulder joint.
- the data processing system 1015 may communicably couple with the computing device 1010 via a communications link or network 1050 (which may be or include various network connections configured to communicate, transmit, receive, or otherwise exchange data between addresses corresponding to the computing device 1010 and data processing system 1015).
- the network 1050 may be a Local Area Network (LAN), a Wide Area Network (WAN), a Wireless Local Area Network (WLAN), an Internet Area Network (IAN) or cloud-based network, and the like.
- the network 1050 may facilitate communication between the respective components of the joint replacement system 1000, as described in greater herein.
- the joint replacement system 1000 can be communicably coupled with at least one external indicator 700.
- the external indicator 700 can be self-powered, such as by an internal battery, changeable or rechargeable, or can be externally powered.
- the external indicator 700 can include at least one electronic device that measures and reports a body's specific force, angular rate, and sometimes the orientation of the body, using a combination of accelerometers, gyroscopes, and sometimes magnetometers.
- the external indicator 600 can include a system comprising an optical detector and at least one optimal indicator.
- the joint replacement system 1000 and data processing system 1015 can receive signals or data from the external indicator 700.
- the external indicator 700 is generally a self-standing self-powered element, that can be positioned at a specific zone on body’s limb, to communicate (wirelessly) position data for the body's limb zone to the computing device 1010 and data processing system 1015.
- the external indicator 700 can be powered externally and have a wired communication with the computing device 1010 and data processing system 1015 of the joint replacement system 1000.
- the external indicator 700 can include multiple individual IMU sensors, multi-axis such as 6-axis or 9-axis, being cased (e.g., IP 54) and wearable, having an internal battery such as a Lithium battery, changeable or rechargeable, and uses wireless communication protocols such as Bluetooth, BLE, Wi-Fi (e.g., 2.4 GHz), and the like.
- Other internal power source for hardware may include as fuel cell, MEMs micro-generator, or any other suitable compact power supply.
- the data processing system 1015 of the joint replacement system 1000 can include a variety of different components including, but not limited to, an input component and an output component.
- the data processing system 1015 can include additional components, such as an adjustment component, a data analyzing component or a mapping component.
- the data processing system 1015 can include engines such as, but not limited to, interface engines and zoning engines.
- the data processing system 1015 can include at least one database, such as a data repository. In some examples, data repository or database can be remote being accessed through the network 1050.
- the physical metrics such as the contact load magnitude and center of load position, the thickness or height of the device, and/or the anatomical position of the shoulder/arm system, that are measured by the sensors and transmitted to the data processing system 1015 are displayed through an output component of the data processing system 1015.
- a joint replacement system comprising an implantable prosthetic joint replacement device having multiple joint replacement device components and comprising an expandable joint replacement device body receiving a first joint replacement device component and being coupled with a second stemmed joint replacement device component and.
- the expandable device body comprises one expanding member to support an articulating piece to contact with the second joint replacement device component, and one rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member.
- the rotating member can be being rotatably actioned, via a rack with a plurality of gear teeth at the outer circumferential portion, by engaging the rack and gear-teeth with a pinion-like end of an external tool, to train the expanding member into an axial movement and to increase or diminish the height of the expandable device body within a range from 0 to 10 millimeters.
- the expanding member incorporates a plurality of sensors coupled at a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member and/or expandable device body.
- the implantable prosthetic joint replacement system also comprises an external module or hardware to communicably couple with the closed internal module, the component and the plurality of sensors in the expanding member of the expandable device body, and a computing device to support a data processing system, to collect the physical metric, and to render graphical representation of the measured physical metric.
- the physical metric applied onto or related to the expandable device body is rendered and can be related to the height of the expandable device body.
- the closed internal module comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components.
- the sensors are selected among strain gauge sensors, thin foil and semiconductor strain gauge sensors, magnetometers, accelerometers, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, and the like.
- the physical metric is selected among deformation, load or force magnitude and position, distance or length, displacement, temperature and/or humidity.
- the members of the implantable joint replacement device in the joint replacement system are composed of materials selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
- One external anatomical indicator system can be incorporated to determine the anatomical position of the limb where is installed the implantable prosthetic joint replacement device.
- This system is communicably coupled with the computing device and data processing system of the joint replacement system.
- the anatomical position of the limb can be processed as for the other data.
- the system can use one or multiple position sensor(s), inertial measurement unit sensor and/or optical indicator.
- Inertial Measurement Unit (IMU) sensors can be the sensors.
- IMU sensors can be self-powered such as by an internal power battery such as a rechargeable or changeable battery, can include an accelerometer/gyroscope/ magnetometer, and other electronic components such as unit controller, processor, signal conditioning circuit, and communication interface.
- the sensor and/or indicator is installed on the limb where is installed the implantable prosthetic joint replacement device.
- the communication between the external indicator and the computing device and data processing system can be wired or wireless such as via Wi-Fi or Bluetooth communication modes.
- the proposed joint replacement system is used to allow a quantitative assessment of the contact joint load and center of load position during the installation of implantable joint replacement device and components and to help the surgeon to define his/her ideal contact joint load and center of load position for a given height of the device. But it also allows a quantitative monitoring of the contact joint load and center of load position, post-surgery, once the implantable joint replacement device and components are installed in the joint.
- the proposed system allows the surgeon to access more objectively determined data for the contact joint load and center of load position in the artificial joint, the height of the implantable joint replacement device and the anatomical position of the corresponding limb, the measured data being interrelated.
- the data corresponding to the physical metric, the height of the expandable device body and the anatomical position of the limb are processed such as collected in the exemplary data analysis process flowchart 1100 shown in FIG. 11.
- the computing device 1010 and the data processing system 1015 may include software configured to receive, process, and deliver various performance data to other subcomponents and users associated with such a monitoring system.
- the computing device 1010 of the joint replacement system 1000 receives different sets of data that are provided from sensors and indicators: the computing device 1010 receives load measurement data (1102) from the sensors that measure the contact load (1101). In a same way, the computing device 1010 of the joint replacement system 1000 receives length measurement data (1112) from the sensors that measure the length (1111) and can receive the orientation and position measurement data (1122) from the indicators that measure the orientation and position (1121). These measurement data can be received by the computing device 1010 through various specific communication channels. For instance, there can be communication modules for wirelessly communicating data between the various sensors and indicators and the computing device 1010.
- the communication between sensors and indicators and the computing device 1010 may be continuous and data are automatically received through the communication channel, or may be non-continuous but upon request, and data are received after a specific request is sent to the sensors or indicator and acknowledged. Such requests may be sent periodically. In some examples, the data are received in real-time or near real-time.
- the computing device 1010 and the data processing system 1015 may be configured to determine the magnitude and/or location of the center of the load measured by the sensors 600 in the internal module 400 of the expandable device body 1050 (1103).
- the magnitude and location of the load and center of load can be determined by the computing device 1010 and a data processing system 1015 from the received load measurement data. It can be done by analyzing (triangulation) the center based on the relative value of a magnitude and the position of the sensor within the expanding member.
- the computing device 1010 and data processing system 1015 may be configured to determine the height of the expandable body device 105 measured by the sensors 610 in the internal module 400 of the expandable device body 1050 (1113).
- the computing device 1010 and data processing system 1015 can be configured to determine the anatomical position/orientation of the body limb determined by the indicators 700 (1123).
- the computing device 1010 and the data processing system 1015 can compile the data for representation of the compiled data and information in various formats which may be help to the user of such a system.
- the computing device 1010 and the data processing system 1015 can display the magnitude of the load and may also provide a user interface configured to display the instantaneous location of the center of load relative to the center or boundaries of the articular surface (1105).
- Graphical element may be configured to provide the location of the center of load relative to the joint contact surface and to indicate graphically the relative magnitude of the load value. Therefore, the proposed user interface may enable to track, among other things, the location and magnitude of the center of load relative to the joint contact surface (FIG. 11)
- the computing device 1010 and the data processing system 1015 can display a length or a length change as measured between two members or ends of the expandable device body 105, this giving information relative to the height of the expandable device body 105 (1115). Additionally, or alternatively, the computing device 1010 and the data processing system 1015 can display parameters related to the anatomic position and orientation of a body limb and may also provide a user interface configured to display the instantaneous anatomic three-dimensional position and orientation of a body limb (1125).
- the computing device 1010 and the data processing system 1015 can display the values of flexion/extension and intemal/extemal rotation for the limb, and can provide a user interface to provide or display a graphical representation of the limb, such as a femur and a pelvis, a shoulder and a humerus and ulna, etc., based on the instantaneous position/orientation data received from the external indicator 700 (FIG. 11).
- information corresponding to the magnitude and location of the load can be displayed relative to the height of the device body (105).
- the information corresponding to the magnitude and location of the load can also be displayed relative to the height of the device body (105) and to the anatomical position and orientation of the limb.
- the computing device 1010 and the data processing system 1015 may also include a user interface element that is configured to display data or representations that tracks and relates the measured magnitude of the load to the measured height of the expandable device body as a function of determined anatomical position parameters such as an flexion/extension angle, an abduction/adduction angle, and an intemal/extemal rotation, and others as desired, and the like (1030).
- a user interface element that is configured to display data or representations that tracks and relates the measured magnitude of the load to the measured height of the expandable device body as a function of determined anatomical position parameters such as an flexion/extension angle, an abduction/adduction angle, and an intemal/extemal rotation, and others as desired, and the like (1030).
- the computing device 1010 and the data processing system 1015 may enables the system user to define and provide a descriptive attribute to values or ranges of values of the joint contact load such as “low”, “median”, “high”, “loose”, “optimal” “tight” or “excessive”, and the like. For instance, a user can attribute a “high” or “tight” description to measured load data within a range of 150 lbs and over, or an “acceptable” or “optimal” description to measured load data within a range from 50 to 90 lbs.
- the computing device 1010 and the data processing system 1015 may also provide a user interface that may associate a predefined graphical attribute, such as a color, that is directly related to a descriptive attribute predefined by the user in the system. For example, the measured load data of 150 lbs and over can be described with a “high” attribute and may appear graphically colored in red since the system user initially defined the red color with the “high” attribute for the contact load.
- a predefined graphical attribute such as a color
- the measured load data of 150 lbs and over can be described with a “high” attribute and may appear graphically colored in red since the system user initially defined the red color with the “high” attribute for the contact load.
- the system allows the monitoring the contact loads at an orthopedic joint, the relating of the joint load with other device or anatomical characteristics. It can be particularly useful in evaluating the performances of a replaced or reconstructed body’s joint.
- the device-embedded sensors can monitor various physical parameters (load magnitude and orientation.) associated with the orthopedic joint components.
- FIGS. 12A-12C show exemplary images (1050) with the graphical user interface associated with the computing device 1010 and data processing system 1015.
- the exemplary image 1051 may correspond to a situation or case in which the load magnitude or value and center of load position are presented graphically, and concomitantly in relation to the determined height value of the expandable device body 105 and to tracked anatomical parameters of the limb such as joint angles (abduction angle, internal/extemal rotation angle).
- a user himself/herself can define and enter attributes to joint contact loads such as the “loose”, “optimal” and “tight” ranges of load values.
- the anatomical test results can be graphically represented as the measured load value versus the tracked anatomical joint angle values as a function of the measured height of the expandable device body 105.
- Other graphical user interfaces can be associated with the computing device 1010 and data processing system 1015.
- joint replacement system 1000 and to the implantable joint replacement device 100 can be associated a method of using the joint replacement system 1000 and to the implantable joint replacement device 100.
- the joint replacement system 1000 and to the implantable joint replacement device 100 are used as part of a regular total joint replacement procedure, such as a total shoulder arthroplasty or reverse total shoulder arthroplasty.
- the longevity of a joint implant device in a patient’s joint may be associated with a better positioning of the joint replacement device and components, as well as with an optimal tensioning of the joint soft tissues. These will have impact on the level of laxity or tightness that will apply on the prosthetic joint over a long period of time, thus favoring or de-favoring the occurrence of complications and maybe the joint implant survival.
- the force and the position of the point of contact that will be applied from the ball to the socket may be beneficial in reaching an optimal joint laxity.
- the positioning and setting of prosthetic joint replacement device are mainly related to the surgeon’s experience, to subjective data on a case-by-case and practitioner-by practitioner basis.
- a method of using the joint replacement device with sensors and an adjustable height to reach the desired force load magnitude and the desired position of the point of load contact when installing and setting the joint replacement device may be desired.
- a summary workflow example 1200 for a surgical procedure for a reverse total shoulder arthroplasty including the use of the proposed joint replacement system 1000 and implantable joint replacement device 100 is shown. Some steps or acts may not be presented. Also, the steps listed herein do not imply a specific order and may be practiced in different orders depending on the application.
- the humeral preparation 1203 is performed including the creation of the pilot hole through the humeral head along the axis of the humeral shaft, then a intramedullary resection guide step 1204 can be done prior to the humeral broaching 1205.
- a calcar planer can be used to refine the resected surface 1206, then the technique for the insertion of the humeral stem is applied at step 1207.
- the following steps are for the preparation of the glenoid and the installation of the baseplate and gl enosphere: glenoid preparation 1208, baseplate impaction 1209, selection/insertion of baseplate central and peripheral screws 1210, 1211, the selection and assembly of the glenosphere 1212, 1213 and the orientation/impaction of the glenosphere 1214.
- One step 1216 related to the joint implant device is first to unpack the humeral tray components and verify the power and communication.
- the humeral tray and body components are installed and assembled 1218, the humeral tray body being coupled with the humeral stem 102 by the second end 115. Then the joint implant device can be reduced. At this stage the features related to the body 105 can be used to start the measurements 1222 of the desired physical metrics, such as the contact force load and the center of load position and the height of the body 105.
- Another step 1224 is the change/adjustment of the height of the humeral tray body 105. The two steps 1222 and 1224 can be repeated.
- the surgical procedure is completed as normally for a reverse shoulder arthroplasty by repairing and adjusting the subscapularis and completing the surgery 1227, 1228. Steps 1222 and 1224 can eliminate the more complex techniques of removing the trail liner/cup (equivalent to 104) and the subjective evaluation of the joint laxity based on a case-by-case and practitioner-by practitioner basis.
- a method of using the joint replacement system 1000 and to the implantable joint replacement device 100 is described in FIG. 10.
- This method of using the joint replacement system 1000 and to the implantable joint replacement device 100 can also encompass a method of evaluating, setting or balancing or a method to assist and help an operator to evaluate, set or balance the implantable joint replacement device 100.
- the joint replacement system 1000 and to the implantable joint replacement device 100 of the present disclosure can provide an operator, such as an orthopedic surgeon, with more objective and quantified data, such as contact load and center of load position data for an implantable joint replacement device 100, to help them evaluating the state in situ of the implantable joint replacement device 100.
- the joint replacement system 1000 provides more accurately measured physical metrics related to the joint replacement device 100 and the surrounding environment, such as the contact load magnitude and center of load position in the joint replacement device 100, the thickness or height of the device body 105 of the joint replacement device 100, and/or the anatomical position of the shoulder/ arm system that receives the joint replacement device 100.
- the contact load magnitude and center of load position in the joint replacement device 100 are the main crucial physical metrics in the method since they are subjectively estimated intra-operatively and they can not estimate post-surgery.
- the continuous measurement or monitoring of the thickness or height of the device body 105 of the joint replacement device 100 or of the anatomical position of the shoulder/arm system is highly valuable to the proposed system and methods.
- the use of the joint replacement system 1000 starts with the steps of installing a first joint replacement device component and a second joint replacement device component of the implantable joint replacement device 100 in a patient’s articular joint. These steps of installing a first joint replacement device component and a second joint replacement device component of the implantable joint replacement device 100 are surgical steps, and can avoid disrupting and alter the conventional workflow for the installation of an implantable joint replacement device of the same type.
- additional steps of the method can be launched being more specific to the joint replacement system 1000 and the implantable joint replacement device 100.
- These additional steps can include measuring, via a plurality of sensors in the device body, at least one physical metric related to the device body or to a portion of the device body, this physical metric being related to or applied onto the device body, and/or moving, via an external tool, a first end of the device body relative to a second end of the device body, wherein the relative moving changes the height of the body and changes the physical metric related to or applied onto said body, and/or displaying, via a data processing system, the physical metrics related to or applied onto the device body.
- Additional steps can include receiving and collecting, via the data processing system, data corresponding to anatomical position measured by external indicators installed on a limb or a portion of a limb, and/or interrelating or correlating, via the data processing system, measured data corresponding to physical metrics, height of the device body, and anatomical position of the limb, and/or rendering the values and representations of the data corresponding to height of the device body, and anatomical position of the limb.
- Some steps can be repeated as much as desired, for instance to reach measured physical metrics that can be considered as acceptable by the operator.
- a method of using a joint replacement system comprises an implantable prosthetic joint replacement device with a first joint replacement device component and a second stemmed joint replacement device component being installed in an articulating joint of a human or mammalian body. It includes an expandable joint replacement device body that is installed coupled with the second stemmed component and between the said first component and second stemmed component.
- It comprises the steps of: -measuring, via a plurality of sensors located on one expanding member of said expandable device body, at least one physical metric being related to or applied onto said expanding member, and -moving, via an external tool, an expanding member of said expandable device body, said movement of said expanding member, wherein said movement is axial and trains a change of the height of the expandable device body of said joint replacement device, and -displaying or rendering, via a data processing system in a computing device, a representation of said physical metric related to or applied onto the expanding member of said expandable device body.
- the method can include additional steps, presented below, that can be applied individually, concurrently, or independently. These additional steps can be selected among: - activating, via an external module, the plurality of sensors in the expanding member of said expandable device body, and -receiving and transmitting, via an external module, data corresponding to the physical metric detected by the plurality of sensors in the expanding member of said expandable device body, -measuring, via a plurality of indicators installed on a patient’s limb or a portion of the limb, data corresponding to the anatomical position of the patient’s limb or a portion of the limb, and collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s limb or a portion of the limb, and -relating, via the data processing system in a computing device, the data corresponding to said physical metric, said height of the body, and to said anatomical position of the limb, and rendering, via the data processing system in a
- the plurality of sensors in the expanding member of the expandable device body can be activated by an external module, and this external module can receive and transmit the data corresponding to the physical metric detected by the plurality of sensors in the expanding member.
- the physical metric includes the contact load and center of load position applied onto the expandable device body and the height of the expandable device body.
- the implantable prosthetic joint replacement device is a shoulder arthroplasty device, and particularly a reverse shoulder arthroplasty device.
- the height of the expandable device body can be increased or decreased, and the effect of the height of the expandable device body, and the change, on the physical metric applied onto the expanding member and expandable device body, such as the contact load and the center of load position, can be measured and displayed through a computing device and data processing system.
- This method can be applied to define a desired height of the expandable device body when installing an implantable prosthetic joint replacement device more objectively and quantitatively.
- the second component can comprise at least one glenosphere, one baseplate and bone screws, and the stemmed component can basically comprise a humeral stem.
- the proximal humeral body can receive a socket or cup to contact with a sphere of said second component.
- the proposed method can apply to other types of joint replacement device, for example to devices for other joints and to other ball-and-socket (spheroid) joints such as hip.
- the measured and displayed physical metric can include the contact load and center of load position applied on the proximal humeral device body of the shoulder arthroplasty device, and the height of the proximal humeral device body of the shoulder arthroplasty device.
- a shoulder arthroplasty system comprising an implantable reverse shoulder arthroplasty device having an installed first glenosphere component and an installed second humeral stemmed component, wherein an expandable proximal humeral body is coupled with said installed humeral stem component, and comprising the steps of measuring, via a plurality of sensors located on one expanding member of the proximal humeral body, the load magnitude and center of load position being applied onto the expanding member, and displaying or rendering, via a data processing system in a computing device, a representation of the load magnitude and center of load position applied onto the expanding member of the expandable proximal humeral body.
- This method can be applied intra-operatively while a total or partial joint arthroplasty procedure but can also be applied to monitor post-operatively the performance of an implantable reverse shoulder arthroplasty device.
- the method can comprise the additional step of moving, via an external tool, an expanding member of the expandable proximal humeral body, wherein this movement is axial and trains a change in height of the expandable proximal humeral body of the implantable reverse shoulder arthroplasty device. Also, it can include the additional step of activating, via an external module, the plurality of sensors in the expanding member of the expandable proximal humeral body. The method can include the additional step of receiving and transmitting, via an external module, data corresponding to the load magnitude and center of load position detected by the plurality of sensors in the expanding member of the expandable proximal humeral body.
- additional steps on the method include measuring, via a plurality of indicators installed on the patient’s arm or a portion of the arm, data corresponding to the anatomical position of the patient’s arm or a portion of the arm, and collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s arm or a portion of the arm.
- FIG. 14 shows a reverse shoulder arthroplasty device 100 being implanted in a human shoulder joint and incorporating an expandable proximal humeral body 105, where the expandable proximal humeral body 105 can be expanded or diminished in height by using an external adjusting tool 300.
- the change in height of the expandable proximal humeral body 105 can modify the lateralization of the implanted shoulder device and can impact the contact load and the center of load position that apply at the joint between the cup 104 and the glenosphere 101.
- the expandable proximal humeral body 105 can measure and report the evolution of the contact load and the center of load position during the change in height of the expandable proximal humeral body 105. Such data are transmitted to the computing device and can be accessed through the user interface 1150. Therefore, the surgeon can intraoperatively change the height of the expandable proximal humeral body 105, and thus the lateralization of the device, for a given anatomical position or motion, and collect the resulting changes of the contact load and the center of load position in the shoulder joint.
- FIG. 15A and FIG. 15B show an example of typical data that can be collected intraoperatively.
- FIG. 15A and FIG. 15B show the load magnitude and the load location (normalized) in relation to the height (thickness) of the expandable proximal humeral body 105 that were modified within a 6 mm range.
- FIG. 15A presents the load magnitude versus thickness relationship (Al) and the load location (normalized) versus the thickness relationship (A2) for an increasing thickness (height being increased from 0 to +6 mm) at an overhead reach position of the arm (arm at 90° of abduction and arm brought in external rotation to point the sky with the hand, 90° of external rotation).
- the 15B presents the load magnitude versus thickness relationship (Bl) and the load location (normalized) versus the thickness relationship (B2) for a decreasing thickness (height being decreased from +6 mm to 0) at the same overhead reach position.
- the load position/location can be currently reported in polar coordinates by r radial coordinate) and O (angular coordinate, often called the polar angle).
- O angular coordinate, often called the polar angle.
- the determination of the load magnitude or location versus the device height or thickness relationship for a given anatomical position of the arm is an intrinsic part of the method proposed in the present disclosure. Similar curves for the load magnitude and the load location (normalized) in relation to the height (thickness) can be determined for any anatomical position.
- the computing system(s) described herein can include clients and servers.
- a client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
- a server transmits data (e.g., data packets) to a client device (e.g., for purposes of displaying data to or receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.
- the separation of various system components does not require separation in all implementations, and the described program components can be included in a single hardware or software product.
- the components described herein can be a single component, app, or program, or a logic device having one or more processing circuits, or executed by one or more processors of the data processing system(s).
- Modules or components can be implemented in hardware or as computer instructions on a non-transient computer readable storage medium, and modules can be distributed across various hardware or computer based components.
- the systems described above can provide multiple ones of any or each of those components and these components can be provided on either a standalone system or on multiple instantiation in a distributed system.
- the systems and methods described above can be provided as one or more computer-readable programs or executable instructions embodied on or in one or more articles of manufacture.
- the article of manufacture can be cloud storage, a hard disk, a CD-ROM, a flash memory card, a PROM, a RAM, a ROM, or a magnetic tape.
- the computer-readable programs can be implemented in any programming language, such as LISP, PERL, C, C++, C#, PROLOG, or in any byte code language such as JAVA.
- the software programs or executable instructions can be stored on or in one or more articles of manufacture as object code.
- Example and non-limiting module implementation elements include sensors providing any value determined herein, sensors providing any value that is a precursor to a value determined herein, datalink or network hardware including communication chips, oscillating crystals, communication links, cables, twisted pair wiring, coaxial wiring, shielded wiring, transmitters, receivers, or transceivers, logic circuits, hard-wired logic circuits, reconfigurable logic circuits in a particular non-transient state configured according to the module specification, any actuator including at least an electrical, hydraulic, or pneumatic actuator, a solenoid, an opamp, analog control elements (springs, filters, integrators, adders, dividers, gain elements), or digital control elements.
- datalink or network hardware including communication chips, oscillating crystals, communication links, cables, twisted pair wiring, coaxial wiring, shielded wiring, transmitters, receivers, or transceivers, logic circuits, hard-wired logic circuits, reconfigurable logic circuits in a particular non-transient state configured according to the module specification, any actuator including
- the subject matter and the operations described herein can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them.
- the subject matter described herein can be implemented as one or more computer programs, e.g., one or more circuits of computer program instructions, encoded on one or more computer storage media for execution by, or to control the operation of, data processing apparatuses.
- the program instructions can be encoded on an artificially generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus.
- a computer storage medium can be, or be included in, a computer- readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. While a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal. The computer storage medium can also be, or be included in, one or more separate components or media (e.g., multiple CDs, disks, or other storage devices include cloud storage).
- the operations described in this specification can be implemented as operations performed by a data processing apparatus on data stored on one or more computer-readable storage devices or received from other sources.
- the terms “computing device”, “component” or “data processing apparatus” or the like encompass various apparatuses, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations of the foregoing.
- the apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).
- the apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them.
- the apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures.
- a computer program (also known as a program, software, software application, app, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment.
- a computer program can correspond to a file in a file system.
- a computer program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code).
- a computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
- the processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output.
- the processes and logic flows can also be performed by, and apparatuses can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).
- Devices suitable for storing computer program instructions and data can include non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks.
- the processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.
- the subject matter described herein can be implemented in a computing system that includes a back end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front end component, e.g., a client computer having a graphical user interface or a web browser through which a user can interact with an implementation of the subject matter described in this specification, or a combination of one or more such back end, middleware, or front end components.
- the components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network.
- Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
- LAN local area network
- WAN wide area network
- inter-network e.g., the Internet
- peer-to-peer networks e.g., ad hoc peer-to-peer networks.
- references to implementations or elements or acts of the systems and methods herein referred to in the singular may also embrace implementations including a plurality of these elements, and any references in plural to any implementation or element or act herein may also embrace implementations including only a single element.
- References in the singular or plural form are not intended to limit the presently disclosed systems or methods, their components, acts, or elements to single or plural configurations.
- References to any act or element being based on any information, act or element may include implementations where the act or element is based at least in part on any information, act, or element.
- references to “an implementation,” “some implementations,” “one implementation” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the implementation may be included in at least one implementation or embodiment. Such terms as used herein are not necessarily all referring to the same implementation. Any implementation may be combined with any other implementation, inclusively or exclusively, in any manner consistent with the aspects and implementations disclosed herein. [000154] References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms.
- references to at least one of a conjunctive list of terms may be construed as an inclusive OR to indicate any of a single, more than one, and all of the described terms.
- a reference to “at least one of ‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and ‘B’.
- Such references used in conjunction with “comprising” or other open terminology can include additional items.
- the joint implant device 100 can be implanted in a shoulder joint, a knee joint, an ankle joint, or a hip joint.
- Further relative parallel, perpendicular, vertical or other positioning or orientation descriptions include variations within +/-10% or +/-10 degrees of pure vertical, parallel or perpendicular positioning.
- references to “approximately,” “about” “substantially” or other terms of degree include variations of +/- 10% from the given measurement, unit, or range unless explicitly indicated otherwise. Coupled elements can be electrically, mechanically, or physically coupled with one another directly or with intervening elements. Scope of the systems and methods described herein is thus indicated by the appended claims, rather than the foregoing description, and changes that come within the meaning and range of equivalency of the claims are embraced therein. [000158] In this document, the terms “a” or “an” are used to include one or more than one, independent of any other instances or usages of "at least one" or “one or more.” In this document, the term “or” is used to refer to a non-exclusive, unless otherwise indicated.
- proximal can mean closer to the heart and the term “distal” can mean more distant from the heart.
- distal can mean lower or bottom and the term “superior” can mean upper or top.
- anterior can mean towards the front part of the body or the face and the term “posterior” can mean towards the back of the body.
- medial can mean toward the midline of the body and the term “lateral” can mean away from the midline of the body.
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- Heart & Thoracic Surgery (AREA)
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Abstract
The present disclosure relates to an implantable prosthetic joint replacement device having multiple joint replacement device components. The implantable prosthetic joint replacement device includes an expandable joint replacement device body that can receive a first joint replacement device component. The expandable device body can couple with a second stemmed joint replacement device component. The expandable device body includes an expanding member. The expanding member can support an articulating piece to contact with a second joint replacement device component. The expandable device body can expand axially via the expanding member to change a height of the expandable device body within a range from 0 to 10 millimeters. The expanding member includes a plurality of sensors to measure at least one physical metric applied to at least one of the expanding member or expandable device body.
Description
SMART AND EXPANDABLE ARTICULAR JOINT IMPLANT DEVICE,
SYSTEM AND METHOD
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional Application No. 63/520,188, filed on August 17, 2023, which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] Bones, muscles, ligaments, or tendons in a body can become injured and may benefit from medical assistance in order to heal, resolve, or account for the injury.
SUMMARY
[0003] At least one aspect is directed toward an implantable joint replacement device having multiple joint replacement device components. The implantable prosthetic joint replacement device includes multiple joint replacement device components and an expandable joint replacement device body that receives a first joint replacement device component. The expandable device body is coupled with a second stemmed joint replacement device component. The expandable device body includes an expanding member that supports an articulating piece to contact with a second joint replacement device component. The expandable device body can expand axially via its expanding member to change a height of the expandable device body within a range from 0 to 10 millimeters. The expanding member includes a plurality of sensors to detect or measure at least one physical metric applied onto or related to the expanding member or the expandable device body. This plurality of sensors is embodied within a closed internal module, with the internal module communicating with an external module.
[0004] At least one aspect is directed toward an implantable reverse shoulder arthroplasty device that includes a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component. The expandable proximal humeral body includes an expanding member to support a humeral liner to receive the glenosphere component, and includes a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member. The rotating member includes, at an outer circumferential portion, a rack with a plurality of gear teeth and can be rotated by the action on the rack and gear teeth of an external tool having a pinion-like end, and can cause the expanding member to move axially and
to change a height of the expandable proximal humeral body within a range from 0 to 10 millimeters. The expandable proximal humeral body includes a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner. The plurality of sensors are embodied within a closed internal module, with the internal module communicating with an external module.
[0005] At least one aspect of the disclosure is directed toward a joint replacement system that includes an implantable prosthetic joint replacement device. The implantable prosthetic joint replacement device has multiple joint replacement device components and includes an expandable joint replacement device body to receive a first joint replacement device component and to couple with a second stemmed joint replacement device component. The expandable device body includes an expanding member to support an articulating piece to contact with the first joint replacement device component, and a rotating member that is movably engaged, via a plurality of corrugations and threads, with the expanding member. The rotating member can be being rotatably driven, via a rack with a plurality of gear teeth at an outer circumferential portion, by engaging the rack and gear-teeth with a pinion-like end of an external tool to drive the expanding member into an axial movement to change a height of the expandable device body within a range from 0 to 10 millimeters. The expanding member includes a plurality of sensors coupled at a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member and/or expandable device body. The joint replacement system includes an external module or hardware that communicably couples with the closed internal module and the plurality of sensors in the expandable device body. The joint replacement system includes a computing device that supports a data processing system, collects the physical metric, and renders a graphical representation of the physical metric being applied onto or related to the expandable device body. The physical metric can be related to the height of said expandable device body as well as to other parameters.
[0006] At least one aspect of the disclosure is directed toward a shoulder arthroplasty system that includes an implantable reverse shoulder arthroplasty device, having a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component. The shoulder arthroplasty system includes an external module or hardware to communicably couple with the closed internal module the plurality of sensors, a computing
device to support a data processing system, collect the physical metric, and to render graphical representation of the physical metric, and an external anatomical indicator system to determine the anatomical position of the limb where the implantable reverse shoulder arthroplasty device is installed the and to communicably couple with the computing device and data processing system. The expandable proximal humeral body includes an expanding member to support a humeral liner to receive the glenosphere component, and a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member. The rotating member includes, at an outer circumferential portion a rack with a plurality of gear teeth and can be rotated by the action on the rack and gear teeth of an external tool having a pinion-like end and, being driven, it causes the expanding member to move axially to change a height of the expandable proximal humeral body within a range from 0 to 10 millimeters. The expandable proximal humeral body includes a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner. The physical metric applied onto or related to the expandable proximal humeral body can be rendered and can be related to the height of the expandable proximal humeral body and to the anatomical position of the corresponding limb.
[0007] At least one aspect is directed toward a method of using a joint replacement system that includes an implantable prosthetic joint replacement device with an installed first joint replacement device component and an installed second stemmed joint replacement device component. The expandable joint replacement device body can be coupled with the installed second stemmed joint replacement device component. The method includes measuring, via a plurality of sensors located on one expanding member of the expandable device body, at least one physical metric being related to or applied onto this expanding member, and moving, via an external tool, an expanding member of the expandable device body, the movement being axial and causing a change of a height of the expandable device body of the joint replacement device, and displaying or rendering, via a data processing system in a computing device, a representation of the physical metric related to or applied onto the expanding member of this expandable device body.
[0008] At least one aspect is directed toward a method of using a shoulder arthroplasty system including an implantable reverse shoulder arthroplasty device having an installed first glenosphere component and an installed second humeral stemmed component, where an
expandable proximal humeral body is coupled with the installed humeral stem component. The method includes measuring, via a plurality of sensors located on an expanding member of the proximal humeral body, a load magnitude and a center of load position being applied onto the expanding member, and rendering, via a data processing system in a computing device, a representation of the load magnitude and the center of load position applied onto the expanding member of the expandable proximal humeral body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The accompanying drawings are not intended to be drawn to scale. Like reference numbers and designations in the various drawings indicate like elements. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
[00010] FIG. 1 shows example schematic side views of joint replacement prosthesis devices.
[00011] FIG. 2 shows an example side view of an implantable joint replacement prosthesis device and components.
[00012] FIG. 3 shows a side perspective view of a device body and components of an implantable joint replacement device.
[00013] FIG. 4 shows another side perspective view of a device body and components of an implantable joint replacement device.
[00014] FIG. 5 shows another side perspective view of a device body and components of an implantable joint replacement device.
[00015] FIG. 6 shows another side perspective view of a device body and components of an implantable joint replacement device.
[00016] FIGS. 7A-7E show various views of a device body and components of an implantable joint replacement device: FIG. 7A shows a side view of a device body and components of an implantable joint replacement device; FIG. 7B shows perspective views of the device body and use; FIG. 7C shows another side view of the device body incorporating an external locking system; FIG. 7D shows perspective views for device bodies incorporating an internal locking system; FIG. 7E shows perspective views for device bodies incorporating a locking system.
[00017] FIGS. 8A-8B show example views of a prosthetic expanding device body of the joint implant device and an internal module and the components of the internal module.
[00018] FIG. 9 shows example views of the sensors installed on a deformable member or end of the prosthetic expanding device body of the joint replacement device.
[00019] FIG. 10 shows an example view of the components of a joint replacement system.
[00020] FIG. 11 shows an example workflow for the data in the joint replacement system.
[00021] FIGS. 12A-12C show example user interfaces in the joint replacement system.
[00022] FIG. 13 shows an example workflow for the use of the joint replacement system.
[00023] FIG. 14 shows example views of the joint replacement system in a human shoulder joint.
[00024] FIG. 15A-15B show example graphs showing load magnitude and center of load position of the joint replacement system installed into a shoulder joint.
DETAILED DESCRIPTION
[00025] Following below are more detailed descriptions of various concepts related to, and implementations of, methods, apparatuses, and systems of medical devices. The various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways.
[00026] Various medical devices can support several bones, muscles, ligaments, or tendons in a body. Various prosthetic medical devices can be implanted to replace articular joints in a body. Some orthopedic surgery involves resurfacing, replacement, or reconstruction of ball-and-socket joints, such as in the shoulder or hip, the surgeon may want to evaluate the performances of a newly-implanted prosthetic joint device. The biomechanical stability of the joint device is a relevant characteristic, and it can be useful to determine whether the implanted joint device should have an additional adjustment during the surgery. One aspect of the joint performance for ball-and-socket joints resides in the load magnitude and center of load position depending on anatomical positions and ranges of motion.
[00027] The present disclosure relates generally to orthopedic surgery and procedures and, more particularly, to assemblies, devices and systems that can help in performing joint replacements and arthroplasties.
[00028] The present disclosure relates to an implantable joint replacement prosthesis or prosthesis component that provides various advantages, and particularly that of allowing an easier and less stressful intraoperative adjustment of the thickness or height of the prosthesis and the state of tightness or laxity of the joint replacement prosthesis being installed as well as an objectified intraoperative and postoperative follow-up monitoring of the state of tightness or laxity' of the implanted joint replacement prosthesis and/or prosthesis component.
[00029] At least one aim of the present disclosure is to reduce or eliminate the subjectivity related to the evaluation of the state of tightness or laxity of a joint replacement prosthesis when being installed in the patient.
[00030] At least one aim of the present disclosure is to enable a fast and easy adjustment of the size of an implantable joint replacement prosthesis or one of the prosthesis components whilst avoiding a removal of a joint replacement prosthesis component at each size adjustment. For instance, it would be beneficial to have the ability of a fast and easy expansion or reduction of the thickness or height of one joint replacement prosthesis component. The adjustment of the thickness or height of one joint replacement prosthesis component may affect the state of tightness or laxity of a joint replacement prosthesis.
[00031] At least one aim of the present disclosure is to enable the measuring, recording and displaying of one or more physical metric that is applied onto the installed joint replacement prosthesis or one prosthesis component. Such physical metric can be related to the state of tightness or laxity of a joint replacement prosthesis and can be also related to the tension of/from the surrounding soft tissues.
[00032] At least one aim of the present disclosure is to provide a mean of evaluating and balancing the installation of an implantable joint replacement prosthesis or prosthesis component to reach a quantified and/or desired state of tightness or laxity. Therefore, during the installation of the joint replacement prosthesis, the surgeon can measure and quantify the current state of tightness or laxity of the joint replacement prosthesis component and can adjust intraoperatively the size of the joint replacement prosthesis component to reach an optimal state of tightness or
laxity of the joint replacement prosthesis component. It is thus provided an objective mean of balancing the state of tightness or laxity of the joint replacement prosthesis component.
[00033] At least one aim of the present disclosure is to provide a mean of measuring and quantifying post-surgery (postoperatively) the state of tightness or laxity of an implanted joint replacement prosthesis. Therefore, a quantitative and objective evaluation of the state of tightness or laxity of the implanted joint replacement prosthesis can be done during the postoperative follow up monitoring, especially in case of complications related to possible mechanical changes.
[00034] The present disclosure generally refers to devices, systems and methods for evaluating a joint replacement prosthesis. The present disclosure refers generally to devices, systems and methods of evaluating a joint replacement prosthesis, determining a measurement of a physical metric related to the joint replacement prosthesis and displaying a measurement of a physical metric related to the joint replacement prosthesis. The present disclosure refers also to a method of balancing a joint replacement prosthesis during its installation/implantation, by adjusting a size of the joint replacement prosthesis based on the physical metric measured on the joint replacement prosthesis.
[00035] This technical solution is generally directed to a medical device. For example, this technical solution is generally directed to an implantable joint replacement prosthesis device, or a joint replacement implant device or a prosthetic joint implant device for coupling to a joint of a human body such as a shoulder joint, a hip joint, an ankle joint, an elbow joint, or a knee joint. The technical solution can also incorporate the medical device into a medical system or a method.
[00036] The present disclosure generally refers to devices, systems and methods for evaluating a joint replacement implant device. The present disclosure refers generally to devices, systems and methods of evaluating a joint replacement implant device or one of the components, determining a measurement of physical metrics related to the joint replacement implant device or one of the components, and displaying a measurement of physical metrics related to the joint replacement implant device. The present disclosure refers also to a method of using the proposed devices and systems, for balancing a joint replacement implant device during the installation/implantation, such as though the state of laxity or tightness, by adjusting a size of the joint replacement implant device or one of the components based on the physical metric measured on the joint replacement implant device or one of the components.
[00037] Joint replacement procedures are among the orthopedic surgical procedures and represents a major number of orthopedic surgical procedures including the total hip arthroplasty (THA) and total knee arthroplasty (TKA). The shoulder joint replacement through total shoulder arthroplasty (TSA) is expanding especially due to an increasing interest for reverse total shoulder arthroplasty (rTSA).
[00038] By way of example, in a first step once the patient is positioned for surgery, the surgical incision is done, and the shoulder is exposed. In the following steps, the humeral preparation can be performed including the creation of the pilot hole through the humeral head along the axis of the humeral shaft, then an intramedullary resection guide step can be done prior to the humeral broaching. A calcar planer can be used to refine the resected surface, then the technique for the insertion of the humeral stem can be applied. The following steps can be for the preparation of the glenoid and the installation of the baseplate and glenosphere: glenoid preparation, baseplate impaction, selection/insertion of baseplate central and peripheral screws, the selection and assembly of the glenosphere and the orientation/impaction of the glenosphere. In some instances, the humerus is again dislocated upwards and outwards taking care not to entrap the medial part of the metaphysis under the glenosphere. The trial humeral device is then positioned, and the prosthesis is reduced. The height of the metaphyseal element and/or the polyethylene insert can be chosen by testing of muscular tension. However, there can be no objective criteria for this evaluation Once the final components have been chosen, they can be implanted: the final humeral component is fixed, whether it is monoblock or pre-assembled, with the diaphyseal component and the epiphysio-metaphyseal element. In some instances, the surgical procedure is completed as normally for a reverse shoulder arthroplasty by repairing and adjusting the subscapularis and completing the surgery.
[00039] Generally, joints of a human body, such as shoulder joints, hip joints, and others, are complex in nature. During joint replacement or reparation surgery, restoring the center of rotation can include evaluating soft tissue tension and balance about the joint, as the jointsurrounding soft tissues play a role in optimizing joint function for joint replacement surgery. Current joint replacement implants focus on bone anatomy and alignment without addressing soft tissue tension. However, optimizing soft tissue tension would provide several advantages. Conventional implants can include a fixed inclination and rely on subjective measures to cut bones to achieve the desired height, tilt, inclination, or rotation of the implant. Thus, achieving
adequate soft tissue tension is difficult and there can be a need to detect tension or compression loads that apply at the joint and onto the joint implant.
[00040] This can be relevant with shoulder implants for shoulder dislocation or with any joint replacement implant device that generally has a ball and socket joint form, as it is difficult to detect magnitude and direction of a load force of an unconstrained or semi-constrained ball and socket joint. Joints of a human body, such as the shoulder joint, rely on soft tissues to provide an extensive range of motion with a high level of stability of the joint. For instance, when one or more portions of the shoulder joint is damaged, such as tearing of a rotator cuff, both range of motion and stability (e.g., location) of the shoulder joint can be compromised, causing instability or fracture. Various prosthesis joint replacement operations, such as a reverse shoulder replacement, can employ a medical implant device that uses the deltoid muscle to restore shoulder functions. For instance, during reverse shoulder replacement, anatomic shoulder replacements, or hemiarthro-plasty, for example, surgeons can install a prosthesis or implant with some tension or compression on one or more muscles, such as the deltoid muscle. To reach a desired tension, surgeons can maneuver the arm of a patient to subjectively evaluate the tension and stability of the joint (e.g., via patient feedback), which can be time consuming or ineffective due to a too high subjectivity.
[00041] The shoulder joint case represents a good example because the shoulder joint can be totally replaced, and anatomic and reverse shoulder joint replacement implant devices are available to operate such joint replacements. For instance, in the case of reverse shoulder joint replacements, the outcome can be dependent on a proper tension of the soft tissues surrounding the shoulder joint. With the rotator cuff being absent, it is mainly from the deltoid tension that will come the stability of the shoulder joint, by holding the ball-and-socket (spheroid) joint together. So, for a reverse shoulder joint replacement, the stability (laxity or tightness) of the prosthetic shoulder joint should be as optimal as possible to avoid potential clinical and mechanical complications such as a joint dislocation. In some cases, the surgeon evaluates the mechanical stability (laxity or tightness) of the shoulder joint replacement implant, before installing definitively the shoulder joint replacement implant. This can be achieved through a shoulder joint implant component, often defined as a liner, which is available in different sizes: the surgeon will perform a reduction of the shoulder joint to install a selected liner onto the humeral head and to evaluate the soft tissue tension. The joint reduction can use high forces to be applied onto the humerus and surrounding soft tissues. But, this operation will be repeated as
desired with different liners and different liner sizes, until a correct liner is selected and a correct soft tissue tension is reached. At this end, the shoulder joint can be dislocated, and the surgeon can install the final shoulder joint replacement implant. The joint dislocation is another difficult step since it uses high forces to be applied. Therefore, such reduction and dislocation procedures are potentially difficult.
[00042] One problem with the installation of a shoulder joint replacement device such as a reverse shoulder joint replacement device remains in the subjective method being used to estimate and establish a proper soft tissue tension. If it often takes several attempts and several joint reduction/dislocation before an acceptable stability is established, this trail and error approach is highly subjective and is based on case-by-case and practitioner-by practitioner situation. Another problem related to the estimation and setting of a proper soft-tissue tension is the fact that the patient is under anesthesia and in a relaxed state during the surgery, which can increase the lack of accuracy on an already quite subjective evaluation method. And, when the surgeon has ultimately installed the shoulder joint replacement device in the patient, there is little means to control the physical metric(s) related to the soft-tissue tension, if there is some shift or changes in this soft-tissue tension.
[00043] Thus, there may be a need for an adjustable implantable joint replacement device that can reduce or expand the size of the device when being installed in position within the joint. For example, there may be a need for an implantable humeral head or tray of a shoulder joint replacement device where the implantable humeral head or tray can be installed on a humeral stem, and where the humeral head or tray can be adjusted in size, such as in height of thickness, during the surgery, thus avoiding the reduction/dislocation process with the humeral liners. For example, there may be a need for an implanted humeral tray or head that can be adjusted in height by the action of an non-implantable external tool that will be used to engage with and activate the adjusting mechanism within the humeral tray or head component of the shoulder joint replacement device.
[00044] There may be a need for an implantable joint replacement device that can measure and report one or several physical metric(s) that apply onto the implantable joint replacement device or one of the components. For example, there may be a need for an implantable joint replacement device that can measure or report joint load characteristics that are directly related to the tension of the soft tissues surrounding the implantable joint replacement device. For example, there may be a need for an implantable shoulder joint replacement device that can measure and report the
contact force load and center of load position at the ball-and-socket (spheroid) contact within the shoulder joint system. This force load magnitude and position are directly related to the stability, laxity or tightness, of the shoulder joint system and are directly impacted by the tension applied by surrounding soft tissues.
[00045] There may be a need for an implantable joint replacement system that can enable to provide interrelated anatomical parameter(s), physical metric(s) and device data during the course of the installation of an implantable joint replacement device. For example, there may be a need for an implantable shoulder joint system that can provide and interrelate data corresponding to the contact force load and center of load position within the shoulder joint system and data corresponding to the size of the shoulder joint device with data corresponding to the anatomical position of the arm where is installed the implantable shoulder joint device. Such a system would allow to display a dynamic view of the interrelations of the aforementioned data.
[00046] The technical solution in the present disclosure aims at reducing the need for installing/removing device or component trials in order to establish the good stability level for an implantable joint replacement device. For instance, the present solution aims at reducing the trialing process performed by the surgeon during the installation of an implantable shoulder joint replacement device and the reduction/dislocation steps during this trialing. In the present disclosure, smart and expandable joint replacement devices and systems are proposed which will eliminate the subjective and potentially traumatic trialing during the installation of the joint replacement device.
[00047] As described herein, the present disclosure relates to an implantable joint replacement device that includes an adjusting mechanism that is incorporated within the body of one device component of the implantable joint replacement device to enable an easy increase or decrease of the height or thickness of the device component and of the joint replacement device. The adjusting mechanism in the joint replacement device may activated by a non-implantable external tool or instrument. Taking the example of a shoulder joint replacement device, such as a reverse shoulder joint replacement device composed of multiple joint device components including a baseplate, a glenoid sphere, bone screws, a humeral stem, a humeral tray and a humeral liner, the adjusting mechanism of the reverse shoulder joint replacement device can be incorporated within the humeral tray component. The mechanism activation leads to an increase of decrease of the humeral tray height and consequently of the implant lateralization.
[00048] The implantable joint replacement device can include sensing capability that is incorporated within the body of one device component of the implantable joint replacement device to measure and report physical metrics applied onto one device component of the joint replacement device. One way of providing such a feature is to have a sensored device component with the implantable joint replacement device. Sensors can measure and provide surgeons with objective data regarding the orientation, location, and amplitude of force on the implantable joint replacement device. Furthermore, this technical solution can provide precise force magnitude and direction readings using sensors at a useful point of a ball-and-socket (spheroid) joint of the device. This would help the surgeon to have a better understanding on the positioning of the implantable joint replacement device at the time of surgery. Taking again the example of a shoulder joint replacement device, the humeral tray of the reverse shoulder joint replacement device can incorporate sensored elements to measure and report the contact force magnitude and orientation that apply onto the humeral liner and tray.
[00049] Furthermore, if the orientation or level of contact force is found to be inadequate during the surgery, the technical solution can propose a prosthetic joint implant where some adjustment can be brought with a less aggressive and simpler action such as using an instrument or tool.
[00050] Further, this technical solution can have many benefits over existing medical device evaluating systems. For example, by determining accurate and objective data measurements using various computing devices and sensors over an interface of a joint, the technical solution can provide more precise physical metrics of a medical device in comparison to manual evaluation techniques. Furthermore, since evaluation and adjustment techniques can be generated manually, such adjustments can be derived based on subjective data on a case-by-case and practitioner-by practitioner basis. This technical solution provides for real-time, repeatable, and accurate evaluation outcomes to more efficiently and effectively adjust a medical device to meet patient needs.
[00051] The present disclosure generally relates to a prosthetic joint implant device that includes a ball and socket joint. The joint implant device can include a plurality of sensors to detect a magnitude and direction along an interface between the ball and socket of the ball and socket joint. Further, the prosthetic joint implant can enable an adjustment of the prosthetic joint implant.
[00052] FIG. 1 illustrates example partial side view schematics of an implantable prosthetic ball-and-socket (spheroid) joint replacement device 100 in which a “ball” component 101 articulates through an articulating surface 135 with a “socket” or cup 104, where the socket 104 can be received and coupled with a joint replacement device body 105 of the implantable joint replacement device 100.
[00053] FIG. 2 illustrates an example implantable joint replacement device 100. For example, the implantable prosthetic joint replacement device 100 can relate to various joints in a body such as a shoulder joint, a hip joint, an ankle joint, a knee joint, a wrist joint, an elbow joint, or another body joint. While the implantable joint replacement device 100 described in reference to the figures generally relates to a shoulder joint, such as a shoulder arthroplasty device, the implantable joint replacement device 100 can be used with various other joints.
[00054] The implantable prosthetic joint replacement device 100 can generally include a first joint replacement device component (or “joint device component”) coupled with a first bone of the body joint and a second joint replacement device component (or “joint device component”) coupled with a second bone of the body joint. For instance, the implantable joint replacement device 100 can include a first joint device component having a convex surface or a ball 101, that can couple with a bone of the human or mammalian body joint through bone screws 103 and a second joint device component that can couple with another bone of the human or mammalian body joint through a stem 102. The implantable prosthetic joint replacement device 100 can include a concave component or socket 104 that receives the convex component or ball 101. For instance, the device can be a reverse total shoulder arthroscopy prosthesis, involving a humeral device component and a glenoid device component. For example, ball 101 can be the glenoid sphere of the glenoid device component, the socket 104 can be the humeral cup or liner, and the stem 102 can be the humeral stem of the humeral device component. The implantable prosthetic joint replacement device 100 and the components or parts can be made from various metallic or non-metallic materials that are currently used and accepted in long-term prosthetic joint replacement implants, including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
[00055] The implantable prosthetic joint replacement device 100 can include at least one joint replacement device body component 105 (FIG. 1 and FIG. 2, among others). The joint
replacement device body 105 can be made from various metallic or non-metallic materials that are currently used and accepted in long-term prosthetic joint replacement implants, including, but not limited to, chromium, nickel, stainless steels, titanium, alloys, plastics, polyethylene, such as ultra-high-molecular-weight polyethylene, polyether-etherketone (peek) or ceramics and the like. The device body 105 include several parts or members. For example, one first member can act as an end to couple with or receive the socket 104 that will receive the first joint device component, such as the ball 101 (such as a glenoid sphere component), and another member can act as another opposite end to couple with the second joint device component, such as the stem 102.
[00056] In the example of the reverse shoulder arthroplasty device shown in FIG. 2, the joint replacement device components can include bone screws 103, a baseplate 106, the glenosphere ball 101, the humeral liner or socket 104, a humeral tray, 105 or a humeral stem 102.
[00057] The joint replacement device body 105 can include an expandable joint replacement device body (expandable body device) that includes an expanding member or end 110. The expanding member or end, also called first member or first end 110 can correspond in shape with the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.). The implantable joint replacement device 100 and the expandable device body 105 can have a common rotation axis 200.
[00058] The first member or end 110 have a specific shape, a grail or chalice shape, including an upper bowl portion 113 with a rim 111 and a guiding concave surface 125 to support the socket or liner 104 that will receive the first joint component, such as a convex part or ball 101, a short stem 112 and a lower foot/base 114 with a lower surface 115. In a concave-convex or ball- and-socket (spheroid) joint, the mechanical loads at the joint contact, that are applied from the first joint device component onto the socket or liner 104, can be transmitted to the first end 110 and the structure to the expandable device body 105. The first member 110 can be a deformable member, so that the load-induced deformations applied from the bowl portion 113 and guiding concave surface 125 to the lower foot/base 114 and lower surface 115. Therefore, a contact load applied onto the first end/deformable member 110 can be determined through microdeformations detected at the lower surface 115 of the lower foot/base 114. Moreover, the grail/chalice shape of the first member 110 can support and withstand the maximum mechanical loads applied by the first joint device component onto the socket or liner 104 to the first member 110 and to the expandable device body 105. The socket or liner 104 can be of various shapes
(symmetric or non, with angulation or not) and can be clipped and removable easily from the member 110.
[00059] The expandable device body 105 of the implantable joint replacement device 100 can include a second member 120. For example, the second member 120 can be the end of the expandable device body 105 that can couple to a second joint device component, such as a stem 102 such as a humeral stem via an attachment projection 130. The second member 120 can be coupled with a second joint device component 102 through a taper connection, a taper connection plus a screw, a screw, and other types of connection. The attachment projection 130 can include a taper, hole, slot, aperture, or other similar opening for receiving a portion of the second joint device component.
[00060] The second member or end 120 can oppose the first member or end 110, as shown throughout the figures (FIG. 3). The second member 120 can correspond in shape with the first member 110 and the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.). The expandable device body 105, the first member 110 and the second member 120 can have a common rotation axis 200. The expandable device body 105 can include an arcuate or angled shape such that the first member 110 and the second member 120 are disposed at an angle. The first member 110 can be an expanding or extension member. For example, it can move relatively to the second basis member 120. For instance, the first member 110 can move longitudinally along the axis relative to the second basis member 120, and therefore the expandable device body 105 can expand or diminish longitudinally between the first 110 and second 120 members or ends. Thus, the height or thickness of the expandable device body 105 can be defined as a length between one axial point of the second member 120 and one axial point of the first member 110, can expand and diminish. To move relatively to the second member 120, an external activation can be applied onto the first member 110 thus inducing the movement of the expanding member 110 in the expandable device body 105. Various means of activation and extension are discussed herein.
[00061] The implantable prosthetic joint replacement device 100 can include an expandable device body 105 and a socket/liner 104. The expandable device body 105 can include a first member 110 and a second member 120 with the attachment projection 130. The first end or member 110 can be an expanding member and a deformable member of the expandable device body 105. The first end or member 110 can be a deformable member and can be coupled with another expanding member 150 of the expandable device body 105. The first member 110 can
couple with several other members or supports within the expandable device body 105. The expandable device body 105 can include another rotating member 140, rotatably coupled with the second member or end 120 and the expanding member 150. This rotating member 140 can rotate around the longitudinal axis 200 of the expandable device body 105, relative to the second member 120 and the expanding member 150. The rotating member 140 can rotate and may not translate relative to the second basis member 120. The rotating member 140 can correspond in shape with the expandable device body 105 (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.). In some examples, the rotating member 140 can have a complete cylindrical shape along the central axis, or the rotating member 140 can have an incomplete cylindrical shape such as an incomplete circular ring.
[00062] The first member 110 of the expandable device body 105 can be designed, shaped, as well as made of a material with determined (or calibrated) structural integrity, such that pressures, loads or forces acting on the socket 104, on the guiding concave surface 125, and on the first end and member 110 are transferred one way or another to a lower portion of the first end and member 110 such as the lower foot/base 114 and lower surface 115 where are installed the load sensors 600. The first member 110 of the expandable device body 105 can be designed, shaped, as well as made of a material with sufficient structural integrity to physically resist the maximal loads applied onto the first member 110 and to provide the desired endurance to the first member 110 of the expandable device body 105.
[00063] The rotating member 140 can include a plurality of corrugations 210 at the internal surface, and the expanding member 150 can include a plurality of corrugations 220 at the external surface. The plurality of corrugations 210 can engage with the plurality of corrugations 220 so that the members 150 and 140 are movably coupled: the rotating member 140 can rotate axially relative to the expanding member 150 and the expanding member 150 can move axially (longitudinally) relative to the member 140. The expanding member 150 can include a first gear 230 at the external surface or the rotating member 140 can include a first gear 230 at the external surface. This first gear 230 can be linear or circular. In some cases, the longitudinal movement (along the axis) of the expanding member 150 can be actioned through the activation of this external first gear 230 by a second gear 310 located at the extremity 305 of an external tool 300.
[00064] In an example of the present disclosure (FIG. 4), an expandable device body 105 of an implantable prosthetic joint replacement device 100 can include one first member or end 110 coupled with one expanding member 150. This first expanding member 150 can have a plurality
of corrugations 220, such as oriented buttress threads, and an axial gear rack 230 at the outer surface. The main expandable device body 105 of the joint replacement device 100 can include a second member or end 120 that is rotatably coupled with a rotating member 140. This second rotating member 140 can have the shape of a deformable incomplete ring and can include a plurality of corrugations 210, such as oriented buttress threads, at the inner surface. The first expanding member 150 movably couples with the second member 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both expanding member 150 and second member 120 are rotatably blocked though rotation retainer elements. An external tool 300 having a pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the expanding member 150. Through the oriented buttress threads mechanism 210 and 220 on the members 140 and 150, a unidirectional and/or longitudinal movement of the expanding member 150 can be made possible through the deformation of the rotating member 140. The moving of the expanding member 150 can be incremental and unidirectional depending on the thread geometry. To move the expanding member 150 in the opposite longitudinal direction, the rotating member 140 can be externally deformed to disengage the oriented buttress threads 210 and 220. This can result in a displacement of the expanding member 150 relative to the rotating member 140, thus an increase of the total height or thickness of the expandable device body 105. A full bidirectional movement of the expanding member 150 relative to the rotating member 140 and to the second member 120 of the expandable device body 105 can occur when the rotating member 140 is deformed and the plurality of corrugations 210 is disengaged from the plurality of corrugations 220 of the expanding member 150.
[00065] In an example of the present disclosure (FIG. 5), the expandable device body 105 of an implantable joint replacement device 100 can include one first end or member 110 coupled with one expanding member 150. This expanding member 150 can have a plurality of corrugations 220 and an axial gear rack 230 at the outer surface. The expandable device body 105 of the implantable joint replacement device 100 can include a second basis member 120 that is rotatably coupled with a rotating member 140. This rotating member 140 can include a plurality of corrugations 210 at the inner surface. The expanding member 150 movably couples with the second basis member or end 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both expanding member 150 and second basis member 120 are rotatably blocked though rotation retainer elements. An external tool 300 having pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the extension member 150. This can result in a displacement of the expanding member 150 relative to the
rotating member 140, thus an increase of the total height or thickness of the device body 105. The second rotating 140 can rotating while the expanding member 150 is longitudinally translating. The rotation of the rotating member 140 can be locked through a pin, a screw, a clip, or a more complex piece.
[00066] In the present disclosure, the implantable joint replacement device 100 can include an expandable device body 105 that can include a first end or member 110 and a second basis end or member 120. The first member 110 can act as a deformable member and can be coupled with an extension member 150 or the first member 110 can act as both a deformable and extension member. The second member 120 can be rotatably coupled with a rotating member 140. The expanding member (e.g., 110 or 150) can move longitudinally (axially) relative to the rotating member 140 and second member 120, and the rotating member 140 can rotate relative to the first and second members 110 and 120 and the expanding member (e.g., 110 or 150). In some examples of the present disclosure, the expanding member 150 can include a plurality of corrugations 220 at the outer surface, and the rotating member 140 can include a plurality of corrugations 210 at the internal surface. The plurality of corrugations 220 can engage with the plurality of corrugations 210 to movably couple the members 140 and 150.
[00067] In an example of the present disclosure (FIG. 6), the expandable device body 105 of the implantable joint replacement device 100 can include one first end or member 110 being coupled with one expanding member 150, in which the expanding member 150 can be a member distinct from the deformable member and first end 110. This expanding member 150 can have a plurality of corrugations 220, such as ACME type threads, at the outer surface. The expandable device body 105 of implantable joint replacement device 100 can include a second end 120 that is rotatably coupled with a rotating member 140. This rotating member 140 can include a circular gear rack 230 at a part of the outer surface and a plurality of corrugations 210, such as bevel threads, at the internal surface. The circular gear rack 230 at the outer surface can include a plurality of grooves. The expanding member 150 movably couples with the second end 120 and may not rotate around the longitudinal axis of the expandable device body 105 since both extension member 150 and second end or member 120 are rotatably blocked though rotation retainer elements. The rotating member 140 is rotatably coupled with the second member 120 through multiple dowel pins 170 that are installed peripherally through holes 121 in the second end 120 into a peripheral groove 141 on the member 140. An external tool 300 having pinion-like connection 310 at the connecting end 305 can engage with the gear rack 230 of the rotating
member 140 to activate a rotation of the rotating member 140. The rotating member 140 being rotatably coupled with the second end or member 120, and through the pluralities of corrugations 210 and 220 that can be engaged, the rotation of rotating member 140 can lead to the longitudinal moving of the extension member 150 in and relative to the second end 120. The longitudinal moving of the expanding member 150 can cause the longitudinal moving of the first end 110 since they are coupled together. Therefore, a longitudinal (axial) displacement of the expanding member 150 relative to the rotating member 140 can result, in a longitudinal (axial) direction of the first member 110 relative to the second end 120, thus leading to an increase or a decrease of the total height or thickness of the expandable device body 105. The rotation of the rotating member 140 can be locked through a pin, a screw, a clip, or a more complex piece.
[00068] In an example of the present disclosure (FIG. 7A-7E), the first member 110 and the expanding member 150 can be fused together (and numbered 110), therefore the plurality of corrugations or threads 220 can be at the external surface portion of the first member 110. The new first member 110 can be movably coupled with the rotating member 140 by the pluralities of corrugations or threads 210 and 220 on the first member 110 and rotating member 140. The longitudinal (axial) movement of the first end 110 can be activated by the rotation of the member 140 through the action of the external tool 300 and the geared end 310 on the external gear rack 230 of the rotating member 140. This leads to a longitudinal movement of the first member 110 relative to the second end or member 120 and by a change in height or thickness of the expandable device body 105.
[00069] The first member 110 or expanding member 150 can be rotatably stopped within the second end or member 120 through rotation retainer guides, such as longitudinal tenon and mortise or pine and gutter, incorporated in the second member 120.
[00070] The rotating member 140 can be rotatably coupled with the second member 120, the rotating member 140 being embedded within the second member 120. It can be done by welding, screwing or by using dowel pins. In some examples, the rotating member 140 is set within the second member 120, said second member or end 120 having two parts being assembled and coupled over the rotating member 140. In some examples, the rotating member 140 is coupled to the second member or end 120 through dowel pins disposed peripherally on the second member 120 into a bevel in the rotating member 140. Therefore, in some examples, the rotating member 140 can rotate around the longitudinal axis 200 of the expandable device body 105 and may not
translate relative to the second member 120 along the longitudinal axis of the expandable device body 105.
[00071] The pluralities of corrugations 210 and 220 can be engaged together and can convert the rotation of the rotating member 140 into an axial translation of the member or end 120, and consequently into the expansion of the height of thickness of the expandable device body 105. This conversion may be performed under a load stress applied onto the expandable device body 105 and the members by the first joint replacement device component of the implantable prosthetic joint replacement device 100. Therefore, this mechanical conversion or transmission may use an effort to counteract the mechanical friction occurring within the engaged corrugations 210 and 220 under the load applied onto the expandable device body 105. The corrugations 210 and 220 can be of various types, can have various geometries or shapes and various angles, and can include threads including, standard threads, V threads, ACME threads, worm, square, buttress, knuckle or Whitworth threads, and the like.
[00072] The expandable device body 105 can allow for an external tool 300 to temporarily couple through the expandable device body 105 with one or more member(s) within the expandable device body 105. In some examples, the external tool 300 can connect with the member 150 of the expandable device 105, or it can connect with the rotating member 140 of the expandable device 105. The external tool 300 can connect with both members 140 and 150 of the expandable device body 105. The external tool 300 includes a connecting end 305 to connect with the member 140 or 150. For instance, one part of the expandable device body 105 can include a slot, hole, aperture, or other similar component to let the external tool 300 connect with the member 140 or 150.
[00073] In some examples, the expanding member 150 in the expandable device body 105 can include a first gear 230 that can be engaged by a second gear 310 at the connecting end 305 of the external tool 300. In some examples, the support 140 of the expandable device body 105 can include a first gear 230 that can be engaged by a second gear 310 at the connecting end 305 of the external tool 300. In some examples, the first and second gears (230 and 310) can engage according to rack and pinion, where the second gear 310 is a pinion. In some examples, this rack and pinion can be linear or circular. In some examples, this rack and pinion is linear and longitudinally oriented. In some examples, the first gear 230 may be another type of gear, such as a worm gear, bevel gear, screw gear, helical gear, or the like. The second gear 310 can include
various types of gear including, but not limited to, pinion, bevel gear, helical gear, screw gear, etc.
[00074] The movement of one member or end, such as the expanding member 150 or first member 110, relative to the other member or end such as the rotating member 140 or second member or end 120, can be locked by different features. In some examples, the rotating member 140 can control and stop the movement of the expanding member 150 through the engagement of a plurality of corrugations 210 on the rotating member 140 with the plurality of corrugations 220 of the expanding member 150. In some examples, the extension member 150 being movably coupled to the rotating member 140, the axial movement of the expanding member 150 can be blocked by immobilizing the rotation of the rotating member 140. The rotating member 140 can be rotatably stopped with the use of a screw or pin that will block the member 140 and avoid driving of the longitudinal movement of the expanding member 150. Different locking systems can be installed to block the motion of either the member 140 or 150, or to avoid the transfer of motion (rotation to translation) between the members 140 and 150.
[00075] In some examples, an external cover member 160 can couple with one member or end of the expandable device body 105. The external cover member 160 can correspond in shape with the expandable device body 105 and the members or ends (e.g., has a cylindrical shape in length along the central axis, a spherical cross-section, etc.). The external cover member 160 can act as an outer skirt and cover the peripheral area of the device body 105 without disabling the connection of the external tool 300 with the members 140 or 150. The external cover member 160 can be made of many materials including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like. The external cover member 160 can be coupled with a member or end of the expandable device body 105 through welding, sticking, screwing, or pining, and the like. In some examples, there may be no external cover member 160 in the expandable device body 105 of the implantable joint replacement device 100. This external cover member 160 may have no impact nor effect on the relative movement of the members and ends in the expandable device body 105.
[00076] In an example shown in FIGS. 7A-7E (e.g., FIG. 7A), the expandable device body 105 of the implantable joint replacement device 100 can include a first member 110, an expanding and deformable member including features of the first member (110) and the
expanding member (150). This merged first member 110 (110+150) can include the same grail or chalice shape with the upper bowl portion 113, rim 111, short stem 112, and the lower foot/base 114 with a lower surface 115. In this case, the lower foot/base 114 can include the plurality of corrugations or threads 220 at the external surface. The plurality of corrugations or threads 220 at the external portion of the foot/base 114 can include flat nerves 117, that are located peripherally, to engage with rotating retainer guides that are disposed at the lower surface inside the second member 120. The rotating retainer guides in the second member 120 can engage within the flat nerves 117 of the first member 110 and disable rotation of the first member 110 in the second member 120 while allowing a relative longitudinal movement of the first member 110 from the second member 120. In some examples, at the lower portion of the first member 110 within the foot/base 114, some ribs or nerves 116 may be present at the lower surface 115, thus giving not a flat lower surface 115 but a multi-stage lower surface 115.
[00077] FIG. 7B shows how the expandable device body 105 of the implantable joint replacement device 100 can be configured to expand or reduce the height of the expandable device body 105. In A (FIG. 7B), the external tool 300 and the pinion-like end can engage with the member 140 and the external rack of gear teeth. The rotating of the external tool 300 can train a rotation of the rotating member 140 in B (FIG. 7B), and since the rotating member 140 is thread-engaged with the expanding member 110, it can train an axial movement of the expanding member 110 and the cup 104 in C. In C (FIG. 7B), the expanding member 110 and the cup 104 can translate relative to the basis member 120 within a range from 0 to 10 millimeters, or from 0 to 6 millimeters, or within another range. Thus, the height of the expandable device body 105 of the implantable joint replacement device 100 can be expanded within a range from 0 to 10 millimeters, or from 0 to 6 millimeters, or within another range.
[00078] In some examples, the expandable device body 105 of the implantable joint replacement device 100 can be lockable. For example, the modular components constitutive of the expandable device body 105 can be lockable to avoid unexpected displacements, and micromotions and micromovements between the modular components once installed in the body joint. For example, modular designs or multi-component devices might allow small levels of undesirable motion, so called micromotion, between the components that should stay firmly locked together after the device is assembled and installed. Micromotions may be an undesirable source of wear that can lower the useful life and endurance of modular implants or degrade the stability of implants over time or increase corrosion. Locking can eliminate or control undesired
movements and micromotions in such multi-component devices. Moreover, it can eliminate movements that may lead to the de-adjusting of the device and an undesired change in physical metrics, such as, for example, a change of the device height.
[00079] In the expandable device body 105 that is a typical multi-component device, a locking system and element can be incorporated to locked together the components and members of the expandable device body 105 such as the members 110, 120, 140 and 150. In some, this locking can be achieved through locking screw(s) or pin(s) or a combination of a piece and a screw or equivalent system. A set screw can be used to lock some of the members such as a rotating member (e.g., 140) in the expandable device body 105 (see FIG. 7C). In the example in FIG. 4, the rotating member 140 can act as a locking member for the adjustable mechanism in the expandable device body 105. There are many other locking systems and/or mechanisms that can be added to and/or incorporated within the expandable device body 105 and the modular components.
[00080] FIG. 7C and FIG. 7D show expandable device bodies 105 that incorporate locking system and elements in addition to the adjusting mechanism and elements. The expandable device body 105 can include the members 110, 120, 140 and 150 for the adjusting mechanism and can incorporate additional members to allow the physical locking of this adjusting mechanism. A variety of locking principles and elements can be applied to the adjusting mechanism of the expandable device body 105, including a partial to complete locking from the locking of the external action to the full locking of the adjusting mechanism itself. For instance, self-locking members, wedging members, flex members, locking clips/rings or other locking elements can be used. In FIG. 7C, the adjusting mechanism in the expandable device body 105 can be locked by externally blocking the rotation of the ring member 140. A pinion-like piece 311 can be externally engaged and fixed using a screw 312 to eliminate rotating of the member 140 through the external tool 300. This type of locking is partial blocking the external access and action onto the adjusting mechanism in the expandable device body 105 while not fully mechanically lock the adjusting mechanism itself. Elements that can be applied to block the action or movement of the ring member 140 include locking clips, pins, screws and the like. As shown in FIG 7D, an additional member 180 incorporated in the expandable device body 105 can act as a locking member to lock the adjusting mechanism when the height of the expandable device body 105 is adjusted. A second external locking tool 350 may be provided to engage with and action the locking nut 180 to lock the mechanism within the expandable device body 105.
For instance, the locking of the system in the expandable device body 105 can be reached through the locking member 180 by acting on deformable flex parts in the expandable device body 105: in D.l, the locking member 180 can use the ring member 140 which has flex walls 151 in the lower part; in D.l, the locking member 180 can engage the ring member 140 to use small flex pallets 121 in the humeral base 120. When actioned, these flex elements 151 or 121 being disposed circumferentially can deform radially and squeeze onto the expandable member 110, thus blocking the height movement in the expandable device body 105. As described herein, an external tool 300 can be used to action the adjusting mechanism of the expandable device body 105, and another external tool 350 can be used to action the locking of the expandable device body 105. The external tools 300 and 350 can be distinct or can be combined in one single external tool.
[00081] In some examples, the first member 110 can have one or multiple channels, apertures, windows, and the like, at or close to the central axis 200 of the first member 110, going through the first member 110 from the lower surface 115 to the upper concave surface 125 that receives the socket or cup 104. In some examples, the upper surface 125 of the first member 110 can incorporate a groove, an open gutter, channel or laugh, going to the periphery of the first member 110 from the central axis region of the first member 110. This groove at the surface 125 can join an axial aperture emerging at the central portion of the first member 110 up to the side of the surface 125 and first member 110.
[00082] FIG. 7E shows another example of the expandable device body 105 incorporating a locking system. The expandable body 105 can support an articulating cup 104. The expandable body 105 can include the members 110, 120, 140, 150 and 180 for an adjusting mechanism. The first member 110 can be also built from two parts 110 and 150. The two parts 110 and 150 may be immovably and ultimately definitively coupled to each other. The second member 120 can be built from two parts (120 and 125). The two parts 120 and 125 can be immovably and ultimately definitively coupled to each other. The second member 120 rotatably embeds or includes the member 140 and 180. The locking principle may be based on the nut and locknut mechanism formed by members 140 and 180. The adjusting and locking mechanisms can be actioned externally by external tools 300 (adjusting) and 350 (locking). These external tools can be independent or can be combined partly or totally. The adjusting tool 300 can drive the member 140 via a pinion-like end 310 that engages with the gears 230 of the member 140. The locking tool 350 can drive the member 180 via a pinion-like end 360 that engages with the gears 240 of
the member 180. These members 300 (adjusting) and 350 (locking) external tools can be manual or powered. An opening 122 in the member 120 (120 + 125) may enable the external tools 300 and 350 to drive the members 140 and 180. The member 110 (110 and 150) can be coupled movably with the members 140 and 180 via the plurality of threads 220, at the outer part of the member 150, that are engaged to the plurality of threads 210 inside the member ring 140 and to the plurality of threads 215 inside the locking member 180.
[00083] In some examples of the present disclosure (FIG. 8A), the first member 110 can incorporate an internal empty chamber volume 400 at the foot/base portion 114. This internal empty chamber volume 400, or internal module 400, can be mainly shaped cylindrical as an open recess at the lower part of the first member 110 and can be defined by the lower surface 115 and the wall surface 118 from the first member 110. This open chamber or internal module 400 can be closed by using a cap or cover 410. This cap or cover 410 can be made of the same material than for the first member 110, including, but not limited to, rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like. In the disclosure, the internal module 400 within the first end 110 can be hermetically closed with the cap or cover 410 to form a sealed enclosure to avoid ingress of fluids or solid particulates. This can be reached by welding, gluing or mechanically using a ring or seal between the cover 410 and the first member 110. In some examples, the hermetic internal module 410 can maintain internally quite a dry environment, such as at a moisture level lower than 5000-7000 ppm.
[00084] Additional to the ability of the expandable device body 105 of the implantable joint replacement device 100 to extend or diminish in length or thickness (or height) between the first member 110 and is second member 120, the implantable joint replacement device 100 can incorporate various components that can detect various metrics, parameters, or characteristics. For example, the implantable joint replacement device 100 can include at least one component to detect one physical metric or multiple physical metrics related to the implantable joint replacement device 100, or a portion thereof, or occurring proximate to the first member 110 of the expandable device body 105. Such physical metrics can be a load or force (e.g., amplitude and direction), a point of load contact, a pressure, a temperature, a humidity level, a position, a deformation, a distance, a length or movement, or other similar physical metrics.
[00085] For example, the first member 110 can include an expanding and deformable member having a bowl portion 113 that supports and withstands the mechanical loads that are applied by the first joint replacement device component onto the socket or liner 104 and to the first member or end 110. Due to the specific grail/chalice shape, the mechanical loads applied onto the first member 110 and the bowl portion 113 can translate into micro-deformations that can be detected at the lower surface 115. Therefore, a contact load applied onto the expanding and deformable member 110 can be determined through the micro-deformations that are generated and can be detected at the lower surface 115 of the lower foot/base 114. For example, detecting the microdeformations can be generated by the contact load applied onto the first member 110 to install one or a plurality of sensors at/on the lower surface 115 of the expanding and deformable member 110.
[00086] As shown in FIG. 9, a plurality of sensors 600, such as a group or set of at least three sensors, can be coupled onto the lower surface 115 of the member 110. It can be one sensor or a group of three or more sensors 600, to reach the adequate accuracy. Each of the sensors 600 can be coupled onto the lower surface 115 such that the sensors 600 are circumferentially positioned about the central axis 200. Each of the sensors 600 can be spaced an equal distance apart from one another circumferentially surrounding the central axis 200. For example, the sensor 600 can circumferentially surround an annular portion of the first member 110 to facilitate detecting an amplitude and direction of a load force placed on the upper portion of the member 110 of the expandable device body 105. In some examples, the joint implant device 100 can include a set with more than three sensors 600. The sensors 600 can be selected among various types of sensors including, but not limited to, strain gauges, bonded and unbonded strain gauges, fine wire strain gauges, thin foil strain gauges, semiconductor strain gauges, photoelectric strain gauges, resistive sensors, piezoelectric / piezoresistive sensors, capacitive sensors, and the like. In some examples, strain gauges that are devices to measure strain on an object can be used for the sensors 600. As an object is deformed, the foils of strain gauges are deformed causing the electrical resistance to change that can be related to the strain, and therefore to the stress or load. The sensors 600 can measure a signal related to and corresponding to a load or force, a pressure, a temperature, a relative humidity, a deformation, a distance, length or movement, a load position or orientation, or other similar physical metrics, and any combination thereof. The sensor 600 can be coupled to the lower surface 115 of the first member 110, and for example can be adhered onto the surface 115 by using bond, glue or adhesive. The adhesive, bond or glue can be coldcuring or fast-curing materials selected among methacrylate, cyanoacrylates, acrylates, epoxy
resins, phenolic resins, and the like. For instance, three sensors 600 can be glued peripherally at the lower surface 115, being positioned at 120° angulation around the central axis 200. For instance, three sensors 600 can be glued peripherally as previously described and one sensor 600 can be glued centrally at the axis position 200. Additionally, circuitry and connections 601 that couple with the set or group of sensors 600 can be added at/to the lower surface 115. In the present disclosure, the sensors 600 and circuitry 601 being installed onto the lower surface 115 of the first member 110 are enclosed within the internal module 400 of the first member 110. Therefore, the sensors 600 and circuitry 601 can be protected within a sealed hermetic internal module 400 of the expanding member 110. The accuracy and reproducibility for the measurements of the load magnitude and center of load position may be dependent on the quality of the assembly and the characterization of the deformable member 110 and the group of sensors 600. The type and number of sensors coupled to the deformable member 110 of the expandable device body 105 may change depending upon the resolution and the desired amount of data. Additional sensors (three, four, five, six, or more sensors) may be used to collect enough data points and to allow for calculation and determination of parameters such as the load magnitude and center of load position. In some instances, the detection and determination of the load magnitude and center of load position applied onto the upper guiding surface 125 of the deformable member or end 110 through the cup or socket 104 can be based on the microdeformations created by the load applied on upper guiding surface 125 of the deformable member or end 110 at the lower surface 115 of the deformable member or end 110. The precise determination and effect of the micro-deformations may depend on the member shape and dimensions 110, the material and mechanical characteristics, as well the precise arrangement of the sensors 600 at the lower surface 115 of the deformable member 110. Strain gauges can be the selected sensors for the lower surface 115 of the deformable member 110: in a resistive and also other circuits of strain gauges, a tension causes a resistance increase, and a compression causes a resistance decrease. A bridge circuit of strain gauges, such as a quarter-bridge, half-bridge, fullbridge, can be installed at the lower surface 115 of the deformable member 110 to detect the load magnitude and center of load position. Calibration may facilitate performing adjustment or set of adjustments on a sensor or group of sensors to make that the sensing system works as accurately, or error free, as possible. This calibration may be individual or generic to the sensing system and may be applied through a computing device and data processing system. For instance, a consistent accuracy about 5 to 15% on the load magnitude and about 2 to 5 mm on the center of load position may be a target.
[00087] In the present disclosure (FIG. 8B), the internal module 400 in the first member 110 can include a variety of components 420, including electronic or electrical components, such as, for example, circuitry, rigid of flexible boards, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components. These components 420 can communicably couple the internal module 400 in the first member 110 of the expandable device body 105 with an external module 500. The external module 500 can be non-implanted and exterior to the implantable joint replacement device 100 and to the body of a patient (FIG. 10). The components 420 can be operatively coupled to each other through various connections, welds, wires, cables, pins, or by direct contact. Such components 420 can include Printed Circuit Boards (PCB), such as sensor PCB (425) and operational PCBs (435), and internal power source such as a battery (430). PCB components (425, 435) can be selected among single-layer, double-layer or multilayer PCBs. The internal module or chamber 400 can also enclose an antenna 450 for the communication and data transmission. The sensor(s) 600 and additional sensor(s) 610 can be enclosed within the internal module 400. In some examples, some elements working with or related to the sensor(s) 610 can be located inside the expandable device body 105 and outside the internal module 400. For example, one or several magnetometers can be included within the internal module 400 and a magnet to work with the magnetometer can be coupled with the second member or another part of the main external device body. The physical disposition of the components 420, such as the PCBs (425, 435), the battery 430 and antenna 450, within the internal module 400 can be various as shown in FIG. 8B (B.l, B.2, B.3 and B.4). In some instances, one battery or several batteries can be assembled directly onto one PCB inside the internal module 400.
[00088] In the present disclosure, the internal module 400 and the components 420 can be active and incorporate a power source and related connectors, such as a rechargeable battery, a changeable or removable battery, and the like (430). The battery 430 can be a non-rechargeable and non-changeable battery. The battery 430 can be a lithium or lithium-ion battery, such as a lithium iodine battery, lithium carbon monofluoride or lithium polycarbon fluoride battery and the like, and it can be a solid state battery. The battery 430 can include multiple battery units. In some examples, the battery within the internal module 400 can be recharged without opening the internal module 400, such as by wireless power transfer. The internal power source can be used to help powering or to fully power the electronic system and components within internal module 400 of the first member 110.
[00089] The internal module 400 can include a plurality of electronic components and other subcomponents that cooperate to detect the load, length or height and other characteristics and performance data and transmit the detected or measured data to an external module 500. The internal module 400 may include electronic circuit boards, Printed Circuit Board (PCB), multichip modules (MCM), or flex circuit boards including microprocessor, communication module, power supply, and one or more sensors. The internal module 400 may be configured to provide both integrated, space-efficient electronic packaging and mechanical support for the various electrical components and subsystems of the internal module 400. The listing of components of the internal module 400 is exemplary only and not intended to be limiting. In the example shown in FIG. 7B, the internal module 400 includes at least one Printed Circuit Board (PCB) which supports elements such as a power management element, a microcontroller element, a wireless communication interface and an analog-to-digital converter (ADC). This PCB can also support the previously described additional sensors 610.
[00090] In the present disclosure, there can be communication and connections between the sealed hermetic internal module 400 and the outside of the internal module 400 and first member 110. This can be done by incorporating hermetic feedthrough connector to connect with components exterior to the internal module 400. The hermetic feedthrough connector enables communicably coupling with the exterior of the internal module 400 and avoids ingress or entrance of fluid, humidity or particulates in the internal module 400.
[00091] In the present disclosure, the expandable device body 105 can incorporate at least one additional sensor 610 where the additional sensor 610 can be independent from the sensor or group of sensors 600. The additional sensor 610 can detect or measure a physical metric, such as a temperature, a relative humidity, a pressure, a distance or displacement, a force, a vibration, a force position, or other similar physical metrics, occurring in a portion of the expandable device body 105. For example, the sensor 610 can be one or more of a magnetometer, accelerometer, LDC (inductive-to-digital converter) based sensors, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, strain gauge, or the like. The expandable device body 105 can include a contact-less sensor system as the additional sensor 610, located within the internal module 400 of the first member 110, to measure the unidirectional or axial change in distance between the first member 110 and the second member 120. This may allow the system to determine the height of the expandable device body 105 and the change of the body 105. The additional sensor 610 can be a contact-less
sensor system having a magnetometer, an inductive-to-digital converter (LDC), or any other contact-less sensing element. The contact-less sensor system can be assembled onto the PCB (425, 435). The contact-less sensor system can have an inductor component located within the internal module 400. In some examples, one or several magnetometers 610 can be coupled with a portion of the expandable device body 105 such as in the internal module 400 of the first member 110, to act as a position sensor. In some examples, the sensor 610 can measure a position or a motion of the first member 110 or can measure the relative displacement of the first member 110 to the second end or member 120, thus providing a value of the height, length or thickness of the expandable device body 105. In some examples, a temperature and/or relative humidity sensor 610 can be additionally coupled within a portion of the expandable device body 105. In the present disclosure, the sensor 610, as for the sensors 600, can be located within the internal module 400 of the first member 110. The additional sensor 610 can be coupled with the surface 115 or can be supported through or by an electronic component, such as a board or a Printed Circuit Board (PCB) and located within the internal module 400 of the first member 110.
[00092] In the present disclosure, the expandable device body 105, the internal module 400 and the components can be activated/deactivated, started/stopped through an internal magnetic sensitive switch such as a reed switch, hall effect switch, and triac or transistor switch. The start/stop or activation/deactivation is performed through the proximity detection of a magnet located in a portable handheld activation system. The magnetic sensitive switch and a logic circuitry enables to connect/disconnect the power source and the electronic circuitry inside the internal module 400. The start/stop or activation/deactivation of can be controlled by the magnetic sensitive switch and may use the simultaneous wireless detection of and connection to an external device such as the external module 500.
[00093] In the present disclosure (FIG. 10), the expandable device body 105 and the internal module 400 can be communicably coupled with the external module 500. The mode of communication between the internal module 400 and the external module 500 can be wireless. Modes of wireless communication can be radiocommunication, radiofrequency communication, mobile communication, infrared communication, microwave communication, Wi-Fi communication and Bluetooth communication. For instance, the modes of wireless communication for electronic implants can be selected among near-field radiofrequency, fairfield radiofrequency, mid-field radiofrequency, electromagnetic, ultrasound and photovoltaic. MICS or Medical Implant Communication System as a short-range communication technology
can be used for wireless communication and transmission, operating at 401-406, 413-419, 426- 432, 438-444, and 451-457 MHz frequency ranges. Other wireless communication frequency range such as 9-315 kHz, 125 kHz-13.56 MHz, 860-960 MHz, 2,45-5.8 GHz, and the like, can be used as they are for implantable medical devices such as implantable pacemakers, defibrillators, neurostimulators, etc. Any wireless communication frequency ranges in the various countries that could be or become available and acceptable for medical devices and implantable medical devices such as the implantable joint replacement device 100 of the present disclosure could be selected for the wireless communication and transmission between the internal module 400 and the external module 500. Wireless communication and connectivity can be provided through protocols such as WiFi, Bluetooth (Bluetooth LE), Near-Field Communications (NFC), MICS, and the like. This selection of wireless modes can extend to a wireless power transfer that can be applied between the internal module 400 and the external module 500 to power the internal module 400 and the elements. The external module 500 may include an active component that can incorporate an internal power source, such as a rechargeable battery, a changeable or removable battery, and the like, and/or can also incorporate a power connector to plug with the mains. It can also be powered by connection with another external active device.
[00094] As shown in FIG. 10, in the present disclosure, the expandable device body 105 of the implantable joint replacement device 100, and the components such as the internal module 400, are coupled communicatively, and wirelessly, with the external module 500, and the external module 500 is coupled communicatively, and wirelessly, with a computing device 1010.
[00095] In the present disclosure, the expandable device body 105 of the implantable joint replacement device 100 can incorporate an antenna 450 to enable wireless communication and transmission between the internal module 400 and the external module 500. In some examples, the antenna 450 can be enclosed within the internal module 400 of the first member 110. In some examples, the antenna 450 may be outside the internal module 400, and outside the first member 110 and still coupled to a portion of the device body 105. For instance, the antenna 450 may be coupled at an outer portion of the expandable device body 105, for instance through the outer surface of the external cover member 160. In some examples, the antenna 450 can be of the second member or end 120. In some examples, the antenna 450 can be a flexible antenna, a flexible PCB antenna, that may conform circumferentially to an external surface part of a member of the expandable device body 105. The antenna 450 may be affixed-coated or embedded within the external cover member 160. To be fully operational, the antenna 450 can be
communicably coupled, e.g., in a wired way, with components of the internal module 400. The antenna 450 may be enclosed, cast, affixed-coated, or embedded at the upper surface 125 of the member 110 such as in polymer, epoxy, peek, ceramic and the like. Such wiring can go from the antenna 450 through the member(s) in the body 105 and through the first member 110 to the inside of the internal module 400 without impairing the hermeticity of the sealed internal module 400, for instance through a feedthrough connector 126 disposed an internal window in the first member 110. The antenna 450 can be selected among several types of antennas such as loop antennas, halo antennas, chip antennas, monopole antennas, and the like, and can support various wireless communication protocols (MICS 405 MHz, Bluetooth Low Energy 2.4 GHz, LoRA/Wi- SUN and other sub-GHz protocols 868-915 MHz).
[00096] In some embodiments of the present disclosure, it is proposed an implantable prosthetic joint replacement device having multiple joint replacement device components and comprising one expandable joint replacement device body receiving a first joint replacement device component and being coupled with a second stemmed joint replacement device component, wherein the device body comprises one expanding member, and wherein the said expanding member supports an articulating piece to contact with the second joint replacement device component, can expand axially related to another member of the device body to expand or diminish the total height of the device body, within a range from 0 to 10 millimeters (or another range, such as 0 to 6 millimeters), and incorporates a plurality of sensors to detect or measure at least one physical metric applied onto or related to the expanding member and/or device body. The device body comprises an expanding member and other members including one rotating member and one basis member, wherein the basis member is coupled with the second stemmed joint replacement device component, and the rotating member is coupled, but remaining rotatably free, with the basis member of the expandable device body. The expanding member is engaged with the rotating member, such as a screw and a bolt, through a plurality of corrugations or threads, with a plurality of corrugations or threads at the external portion of the expanding member and another plurality of corrugations or threads at the internal surface of the rotating member. The rotating member additionally comprises at the outer circumferential portion a rack with a plurality of gear teeth, and this rack with a plurality of gear teeth can be activated or actioned to rotatably train the said rotating member. Since the rotating and expanding members are engaged as screw and bolt, the rotation of the rotating member will train an axial movement of the expanding member relative to the rotating and basis members. The rotating member and the rack with a plurality of gear teeth can be actioned by the use of an external tool having a
pinion gear-like end to engage with the gear teeth. The expanding member can also comprise two separate elements that are integrally coupled together. One element of the expanding member presents at the outer circumferential portion a rack with a plurality of gear teeth, where the rack and plurality of gear teeth can be actioned or activated by engaging with a pinion gear-like end of an external tool, which results in the axial movement of the expanding member relative to the basis member. The expanding member additionally incorporates a closed internal module. The plurality of sensors is coupled to a lower surface inside the closed internal module of the expanding member to withstand micro-deformations and to detect load magnitude and orientation. This closed internal module also comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components. In addition, an antenna can be coupled to the expandable device body but located outside the closed internal module, and this antenna is communicably coupled with the electronic components inside the closed internal module. The closed internal module is communicably coupled with an external module or hardware, for instance through the antenna. Inside the internal module, sensors are communicably coupled to the electronic components and circuitry. The sensors can be selected among accelerometer, magnetometer, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, piezoresistive sensor, strain gauge sensors, and can include thin foil and semiconductor strain gauge sensors. The sensors measure or detect a physical metric selected among deformation, load or force, position, distance or length, displacement, temperature and/or humidity.
[00097] In some examples, the component devices, the members and parts of the expandable device body are composed of materials that can be selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
[00098] The implantable prosthetic joint replacement device can be used to replace a ball-and- socket (spheroid) joint of a human or mammalian body, and can include a hip arthroplasty device or shoulder arthroplasty device. Therefore, the second joint replacement device component can comprise a ball or sphere, and the implantable prosthetic joint replacement device can include a reverse total shoulder arthroplasty device with a first glenosphere component and a second proximal humeral component.
[00099] An implantable reverse shoulder arthroplasty device is proposed having a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component. In this reverse shoulder arthroplasty device, the expandable proximal humeral body comprises an expanding member to support a humeral liner to receive the glenosphere component, and a rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member. This rotating member presents at the outer circumferential portion a rack with a plurality of gear teeth and the rotating member can be rotated by the action an external tool having a pinion-like end on the rack and gear teeth. Also, being actioned in rotation, the rotating member trains the expanding member to move axially and to increase or diminish the height of the expandable proximal humeral body. This expansion in height can be within a range from 0 to 10 millimeters, or from 0 to 6 millimeter. The expandable proximal humeral body also incorporates a plurality of sensors coupled with a surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member via the humeral liner. The rotating member comprises a plurality of threads at the internal surface, and a rack with a plurality of gear teeth at a circumferential portion of the external surface. The expanding member comprises a plurality of threads at a lower portion of the external surface. The closed internal module comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, transponders, tags, resistors, capacitors, communication units, memory units, antenna, or other similar components. Also, the expandable proximal humeral body comprises additionally an antenna outside the closed internal module, and the external antenna is communicably coupled with the electronic components inside the closed internal module. This closed internal module is communicably coupled with an external module or hardware. These sensors are communicably coupled to electronic components and circuitry in the closed internal module. These sensors are selected among accelerometer, magnetometer, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, piezoresistive sensor, strain gauge sensors, and can include thin foil and semiconductor strain gauge sensors.
[000100] The measured or detected physical metric can be selected among deformation, load or force magnitude and position, distance or length, displacement, temperature and/or humidity. The load magnitude and center of load position can be some of the physical metrics along with the displacement between the members of the expandable proximal humeral body. The members of the expandable proximal humeral body and the reverse total shoulder arthroplasty device
components can be composed of materials selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
[000101] FIG. 9 and FIG. 10 shows an illustration of an exemplary joint replacement system 1000 for the detection, measuring and recording of loads and other physical metrics present in the body joint and in the joint replacement device 100. The joint replacement system 1000 can include a system for intra-operative and post-surgery measuring, determining, recording, in realtime or near real-time, and analyzing performance characteristics and parameters at an implanted prosthetic joint replacement device. The performance characteristics and parameters may include anatomical, kinetic, kinematic or biomechanical characteristics and parameters that may be used to evaluate the behavior or performance of a prosthetic joint replacement implant. Representative examples of performance parameters include information indicative of contact load, pressure, angle of flexion and/or extension, torque, angle of abduction and/or adduction, center of load position, angle of internal/ external rotation, range of motion, implant laterization/medialization, and the like. These are non-limiting examples.
[000102] Embodiments consistent with the disclosed systems and methods may be employed in arthroplasty and joint replacement procedures related to ball-and-socket joints, such as the hip and shoulder. Furthermore, certain elements consistent with the presently disclosed systems and methods may be used intra-operatively and post-surgery.
[000103] In the present disclosure (FIG. 10), an external module 500 communicably couples with the internal module 400, the enclosed electronic components 420 and sensors 600 and 610, in the expandable device body 105 of the implantable joint replacement device 100. The external module 500 can be an independent handheld device, or hardware, totally external and independent from the patient’s body, or can be a patch, reinforcement, or the like, that adheres to or is coupled with a portion of a patient’s body (e.g., limb). For example, the external module 500 can be a handheld external module 500. In some examples, the external module 500 can incorporate a power source, such as a battery, a rechargeable, changeable or removable battery, and the like. The external module 500 can be powered through an external source, such as mains, or through a computing device, such as a computer or laptop. In some examples, the external module 500 can receive and analyze the signal from the internal module 400. In some examples, the external module 500 can determine, based on the analyzed signal received from the internal
module 400, data corresponding to physical metrics applied onto the implantable joint replacement device 100. In some examples, the external module 500 can communicably couple to one or more computing devices 1010 to transmit data measured by sensors in the expandable device body 105 of the implantable joint replacement device 100, including data corresponding to the contact load force, the height or thickness of the device body 105, the position of the expandable device body 105 (e.g., within a joint), or orientation in space of the implantable joint replacement device 100.
[000104] In the present disclosure, such as shown on FIG. 10, an example of an implantable joint replacement system 1000 can include an implantable joint replacement device 100, including the internal module 400, one external module 500, one or multiple external indicators 700, a computing device 1010 with a data processing system 1015 and an access to a network 1050
[000105] The implantable joint replacement system 1000 can be for a reverse shoulder joint replacement device 100, with the joint replacement device 100 including the bone screws 103, the baseplate 106 and glenosphere 101, the humeral cup 104 and the humeral tray or body 105, and the humeral stem 102. The joint replacement system 1000 can facilitate evaluating the joint replacement device 100 through the device body 105. As described herein, the joint replacement device 100 of the joint replacement system 1000 includes the internal module 400 inside the device body 105. The internal module 400 can include the one or more sensors 600 and 610 described herein and can transmit signals to and can receive signals from another portion of the joint replacement system 1000, such as to the external module 500. For example, the external module 500 can transmit signals to and can receive signals from the internal module 400. In some examples, the external module 500 can include one or more transceivers or transmitters to transmit a signal from the external module 500 to the internal module 400. In some examples, the external module 500 can include one or more frequency generators such that the external module 500 can transmit radio frequency signals (e.g., oscillations, electromagnetic waves, vibrations, etc.) in multiple directions. For example, the radio signals can reflect off or be absorbed by one or more components of the joint replacement device 100 to create a radio frequency feedback loop between the external module 500 and the internal module 400. One or more components of the internal module 400 can receive one or more signals from the external module 500. As described above, the sensor(s) 600 can detect a load on the joint replacement device 100 and can be installed to measure the load magnitude and center of load position for the contact load force
applied onto the expandable device body 105 and first member 110. The internal module 400 can detect a change or fluctuation of the sensor(s) 600 and can adjust or change one or more properties of a radio frequency loop between the external module 500 and the internal module 400, which can create a change in a reflected signal from the internal module 400 to the external module 500. The external module 500 can receive a signal (e.g., data packet, an indication, etc.) from the internal module 400. For example, the external module 500 can receive a reflected radio frequency signal from the internal module 400 in response to the transmitted signal from the external module 500. For example, the external module 500 can transmit power to the internal module 400, such as by wireless power transfer, for example by near field or non-radiative techniques or by far field or radiative techniques. Such techniques may be selected among inductive coupling, resonant inductive coupling, capacitive coupling, magneto-dynamic coupling, microwaves, and light waves. The external module 500 can include a self-standing self-powered hardware that communicates (wirelessly) measured data to the computing device 1010 and data processing system 1015. The external module 500 can be powered externally and have a wired communication with the computing device 1010 and data processing system 1015 of the joint replacement system 1000. The external module 500 can be a standalone handheld battery- powered transceiver hardware that both communicate, receive and transmit wirelessly signals and data from the internal module 400 of the implantable joint replacement device 100 to the computing device 1010 and data processing system 1015. In some examples, the external module 500 may not include a transceiver hardware that is wired to and powered by the computing device 1010 to both communicate, receive and transmit signals and data from the internal module 400 of the implantable joint replacement device 100 to the computing device 1010 and data processing system 1015.
[000106] The external module can include a wireless communication transceiver 500 may include any device suitable for supporting wireless communication between one or more components of joint replacement system 1000. As described herein, the wireless communication transceiver may be configured for operation according to any number of suitable protocols for supporting wireless, such as, for example, wireless USB, ZigBee, Bluetooth, Wi-Fi, or any other suitable wireless communication protocol or standard. The wireless communication transceiver of the external module 500 may embody a standalone communication module, separate from the computing device. As such, the external module or wireless communication transceiver 500 may be electrically coupled to the computing device 1010 via USB or other data communication link and configured to deliver data received therein to the computing device 1010 for further analysis.
The external module and wireless communication transceiver 500 may include an integrated wireless transceiver chipset, such as the Bluetooth, Wi-Fi, NFC, or 802.1 lx wireless chipset.
[000107] The joint replacement system 1000 can include at least one computing device 1010 that can support and/or communicably couple with at least one data processing system 1015. The computing device 1010 and data processing system 1015 can include several components or engines. The computing device 1010 and data processing system 1015 can include components or engines to transmit or receive data from one or more remote sources (such as the computing devices 1010, the external module 500, or the internal module 400, and other external sources). In some examples, communications device(s) may access the network 1050 to exchange data with various other communications device(s) via cellular access, a modem, broadband, Wi-Fi, satellite access, etc. via the data processing system 1015. The computing device 1010 may be any device(s), component(s), circuit(s), or other combination of hardware components designed or implemented to receive inputs or other signals for evaluating the joint replacement device 100. For example, the computing device 1010 and data processing system 1015 can receive inputs or other signals for evaluating the joint replacement device 100 when the device 100 is being used within a joint, such as a shoulder joint. The data processing system 1015 may communicably couple with the computing device 1010 via a communications link or network 1050 (which may be or include various network connections configured to communicate, transmit, receive, or otherwise exchange data between addresses corresponding to the computing device 1010 and data processing system 1015). The network 1050 may be a Local Area Network (LAN), a Wide Area Network (WAN), a Wireless Local Area Network (WLAN), an Internet Area Network (IAN) or cloud-based network, and the like. The network 1050 may facilitate communication between the respective components of the joint replacement system 1000, as described in greater herein.
[000108] In some examples, the joint replacement system 1000 can be communicably coupled with at least one external indicator 700. The external indicator 700 can be self-powered, such as by an internal battery, changeable or rechargeable, or can be externally powered. The external indicator 700 can include at least one electronic device that measures and reports a body's specific force, angular rate, and sometimes the orientation of the body, using a combination of accelerometers, gyroscopes, and sometimes magnetometers. The external indicator 600 can include a system comprising an optical detector and at least one optimal indicator. In some examples, the joint replacement system 1000 and data processing system 1015 can receive signals or data from the external indicator 700. The external indicator 700 is generally a self-standing
self-powered element, that can be positioned at a specific zone on body’s limb, to communicate (wirelessly) position data for the body's limb zone to the computing device 1010 and data processing system 1015. The external indicator 700 can be powered externally and have a wired communication with the computing device 1010 and data processing system 1015 of the joint replacement system 1000.
[000109] In this disclosure, the external indicator 700 can include multiple individual IMU sensors, multi-axis such as 6-axis or 9-axis, being cased (e.g., IP 54) and wearable, having an internal battery such as a Lithium battery, changeable or rechargeable, and uses wireless communication protocols such as Bluetooth, BLE, Wi-Fi (e.g., 2.4 GHz), and the like. Other internal power source for hardware may include as fuel cell, MEMs micro-generator, or any other suitable compact power supply.
[000110] The data processing system 1015 of the joint replacement system 1000 can include a variety of different components including, but not limited to, an input component and an output component. In some examples, the data processing system 1015 can include additional components, such as an adjustment component, a data analyzing component or a mapping component. In some examples, the data processing system 1015 can include engines such as, but not limited to, interface engines and zoning engines. The data processing system 1015 can include at least one database, such as a data repository. In some examples, data repository or database can be remote being accessed through the network 1050. The physical metrics, such as the contact load magnitude and center of load position, the thickness or height of the device, and/or the anatomical position of the shoulder/arm system, that are measured by the sensors and transmitted to the data processing system 1015 are displayed through an output component of the data processing system 1015.
[000111] In some embodiments, a joint replacement system is proposed comprising an implantable prosthetic joint replacement device having multiple joint replacement device components and comprising an expandable joint replacement device body receiving a first joint replacement device component and being coupled with a second stemmed joint replacement device component and. The expandable device body comprises one expanding member to support an articulating piece to contact with the second joint replacement device component, and one rotating member being movably engaged, via a plurality of corrugations and threads, with the expanding member. The rotating member can be being rotatably actioned, via a rack with a plurality of gear teeth at the outer circumferential portion, by engaging the rack and gear-teeth
with a pinion-like end of an external tool, to train the expanding member into an axial movement and to increase or diminish the height of the expandable device body within a range from 0 to 10 millimeters. The expanding member incorporates a plurality of sensors coupled at a lower surface of the expanding member within a closed internal module of the expanding member to detect or measure at least one physical metric applied onto or related to the expanding member and/or expandable device body. The implantable prosthetic joint replacement system also comprises an external module or hardware to communicably couple with the closed internal module, the component and the plurality of sensors in the expanding member of the expandable device body, and a computing device to support a data processing system, to collect the physical metric, and to render graphical representation of the measured physical metric. The physical metric applied onto or related to the expandable device body is rendered and can be related to the height of the expandable device body.
[000112] The closed internal module comprises electronic components such as boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, antenna, or other similar components. The sensors are selected among strain gauge sensors, thin foil and semiconductor strain gauge sensors, magnetometers, accelerometers, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, and the like. The physical metric is selected among deformation, load or force magnitude and position, distance or length, displacement, temperature and/or humidity.
[000113] The members of the implantable joint replacement device in the joint replacement system are composed of materials selected among rigid metals and alloys (chromium alloys, nickel alloys, stainless alloys, titanium alloys, and the like), plastics (polyethylene, such as ultra- high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and the like) or ceramics, and the like.
[000114] One external anatomical indicator system can be incorporated to determine the anatomical position of the limb where is installed the implantable prosthetic joint replacement device. This system is communicably coupled with the computing device and data processing system of the joint replacement system. The anatomical position of the limb can be processed as for the other data. The system can use one or multiple position sensor(s), inertial measurement unit sensor and/or optical indicator. Inertial Measurement Unit (IMU) sensors can be the sensors. Such IMU sensors can be self-powered such as by an internal power battery such as a
rechargeable or changeable battery, can include an accelerometer/gyroscope/ magnetometer, and other electronic components such as unit controller, processor, signal conditioning circuit, and communication interface. The sensor and/or indicator is installed on the limb where is installed the implantable prosthetic joint replacement device. In this system, the communication between the external indicator and the computing device and data processing system can be wired or wireless such as via Wi-Fi or Bluetooth communication modes.
[000115] The proposed joint replacement system is used to allow a quantitative assessment of the contact joint load and center of load position during the installation of implantable joint replacement device and components and to help the surgeon to define his/her ideal contact joint load and center of load position for a given height of the device. But it also allows a quantitative monitoring of the contact joint load and center of load position, post-surgery, once the implantable joint replacement device and components are installed in the joint. The proposed system allows the surgeon to access more objectively determined data for the contact joint load and center of load position in the artificial joint, the height of the implantable joint replacement device and the anatomical position of the corresponding limb, the measured data being interrelated.
[000116] In the present disclosure, the data corresponding to the physical metric, the height of the expandable device body and the anatomical position of the limb are processed such as collected in the exemplary data analysis process flowchart 1100 shown in FIG. 11. The computing device 1010 and the data processing system 1015 may include software configured to receive, process, and deliver various performance data to other subcomponents and users associated with such a monitoring system.
[000117] As shown in FIG. 11, the computing device 1010 of the joint replacement system 1000 receives different sets of data that are provided from sensors and indicators: the computing device 1010 receives load measurement data (1102) from the sensors that measure the contact load (1101). In a same way, the computing device 1010 of the joint replacement system 1000 receives length measurement data (1112) from the sensors that measure the length (1111) and can receive the orientation and position measurement data (1122) from the indicators that measure the orientation and position (1121). These measurement data can be received by the computing device 1010 through various specific communication channels. For instance, there can be communication modules for wirelessly communicating data between the various sensors and indicators and the computing device 1010. The communication between sensors and indicators
and the computing device 1010 may be continuous and data are automatically received through the communication channel, or may be non-continuous but upon request, and data are received after a specific request is sent to the sensors or indicator and acknowledged. Such requests may be sent periodically. In some examples, the data are received in real-time or near real-time.
[000118] The computing device 1010 and the data processing system 1015 may be configured to determine the magnitude and/or location of the center of the load measured by the sensors 600 in the internal module 400 of the expandable device body 1050 (1103). The magnitude and location of the load and center of load can be determined by the computing device 1010 and a data processing system 1015 from the received load measurement data. It can be done by analyzing (triangulation) the center based on the relative value of a magnitude and the position of the sensor within the expanding member. In a similar way, the computing device 1010 and data processing system 1015 may be configured to determine the height of the expandable body device 105 measured by the sensors 610 in the internal module 400 of the expandable device body 1050 (1113). The computing device 1010 and data processing system 1015 can be configured to determine the anatomical position/orientation of the body limb determined by the indicators 700 (1123).
[000119] Once the computing device 1010 and the data processing system 1015 have received and determined the various parameters related to the load, height and anatomical position, the computing device 1010 and the data processing system 1015 can compile the data for representation of the compiled data and information in various formats which may be help to the user of such a system. For instance, the computing device 1010 and the data processing system 1015 can display the magnitude of the load and may also provide a user interface configured to display the instantaneous location of the center of load relative to the center or boundaries of the articular surface (1105). Graphical element may be configured to provide the location of the center of load relative to the joint contact surface and to indicate graphically the relative magnitude of the load value. Therefore, the proposed user interface may enable to track, among other things, the location and magnitude of the center of load relative to the joint contact surface (FIG. 11)
[000120] In addition to the load magnitude and center of load position, the computing device 1010 and the data processing system 1015 can display a length or a length change as measured between two members or ends of the expandable device body 105, this giving information relative to the height of the expandable device body 105 (1115). Additionally, or alternatively,
the computing device 1010 and the data processing system 1015 can display parameters related to the anatomic position and orientation of a body limb and may also provide a user interface configured to display the instantaneous anatomic three-dimensional position and orientation of a body limb (1125). The computing device 1010 and the data processing system 1015 can display the values of flexion/extension and intemal/extemal rotation for the limb, and can provide a user interface to provide or display a graphical representation of the limb, such as a femur and a pelvis, a shoulder and a humerus and ulna, etc., based on the instantaneous position/orientation data received from the external indicator 700 (FIG. 11).
[000121] Through the user interface related to the computing device 1010 and the data processing system 1015, information corresponding to the magnitude and location of the load can be displayed relative to the height of the device body (105). The information corresponding to the magnitude and location of the load can also be displayed relative to the height of the device body (105) and to the anatomical position and orientation of the limb.
[000122] In the disclosure, the computing device 1010 and the data processing system 1015 may also include a user interface element that is configured to display data or representations that tracks and relates the measured magnitude of the load to the measured height of the expandable device body as a function of determined anatomical position parameters such as an flexion/extension angle, an abduction/adduction angle, and an intemal/extemal rotation, and others as desired, and the like (1030).
[000123] In the disclosure, the computing device 1010 and the data processing system 1015 may enables the system user to define and provide a descriptive attribute to values or ranges of values of the joint contact load such as “low”, “median”, “high”, “loose”, “optimal” “tight” or “excessive”, and the like. For instance, a user can attribute a “high” or “tight” description to measured load data within a range of 150 lbs and over, or an “acceptable” or “optimal” description to measured load data within a range from 50 to 90 lbs. The computing device 1010 and the data processing system 1015 may also provide a user interface that may associate a predefined graphical attribute, such as a color, that is directly related to a descriptive attribute predefined by the user in the system. For example, the measured load data of 150 lbs and over can be described with a “high” attribute and may appear graphically colored in red since the system user initially defined the red color with the “high” attribute for the contact load.
[000124] The system allows the monitoring the contact loads at an orthopedic joint, the relating of the joint load with other device or anatomical characteristics. It can be particularly useful in evaluating the performances of a replaced or reconstructed body’s joint. The device-embedded sensors can monitor various physical parameters (load magnitude and orientation.) associated with the orthopedic joint components. The computing device 1010 and the data processing system 1015 can provide a platform for receiving, compiling, and analyzing the various physical parameters and data and displaying the data in a meaningful way to the user. FIGS. 12A-12C show exemplary images (1050) with the graphical user interface associated with the computing device 1010 and data processing system 1015. The exemplary image 1051 may correspond to a situation or case in which the load magnitude or value and center of load position are presented graphically, and concomitantly in relation to the determined height value of the expandable device body 105 and to tracked anatomical parameters of the limb such as joint angles (abduction angle, internal/extemal rotation angle). In the exemplary image 1052, a user himself/herself can define and enter attributes to joint contact loads such as the “loose”, “optimal” and “tight” ranges of load values. In some examples, the anatomical test results can be graphically represented as the measured load value versus the tracked anatomical joint angle values as a function of the measured height of the expandable device body 105. Other graphical user interfaces can be associated with the computing device 1010 and data processing system 1015.
[000125] Related to the joint replacement system 1000 and to the implantable joint replacement device 100 can be associated a method of using the joint replacement system 1000 and to the implantable joint replacement device 100. The joint replacement system 1000 and to the implantable joint replacement device 100 are used as part of a regular total joint replacement procedure, such as a total shoulder arthroplasty or reverse total shoulder arthroplasty. The longevity of a joint implant device in a patient’s joint may be associated with a better positioning of the joint replacement device and components, as well as with an optimal tensioning of the joint soft tissues. These will have impact on the level of laxity or tightness that will apply on the prosthetic joint over a long period of time, thus favoring or de-favoring the occurrence of complications and maybe the joint implant survival. For instance, in ball-and-socket (spheroid) joints, the force and the position of the point of contact that will be applied from the ball to the socket may be beneficial in reaching an optimal joint laxity. Conventionally, the positioning and setting of prosthetic joint replacement device are mainly related to the surgeon’s experience, to subjective data on a case-by-case and practitioner-by practitioner basis. Thus, a method of using the joint replacement device with sensors and an adjustable height to reach the desired force load
magnitude and the desired position of the point of load contact when installing and setting the joint replacement device may be desired.
[000126] In the present disclosure, as shown in FIG. 13, a summary workflow example 1200 for a surgical procedure for a reverse total shoulder arthroplasty including the use of the proposed joint replacement system 1000 and implantable joint replacement device 100 is shown. Some steps or acts may not be presented. Also, the steps listed herein do not imply a specific order and may be practiced in different orders depending on the application. At step 1202, once the patient is positioned for surgery, the surgical incision is done, and the shoulder is exposed. In the following steps, the humeral preparation 1203 is performed including the creation of the pilot hole through the humeral head along the axis of the humeral shaft, then a intramedullary resection guide step 1204 can be done prior to the humeral broaching 1205. A calcar planer can be used to refine the resected surface 1206, then the technique for the insertion of the humeral stem is applied at step 1207. The following steps are for the preparation of the glenoid and the installation of the baseplate and gl enosphere: glenoid preparation 1208, baseplate impaction 1209, selection/insertion of baseplate central and peripheral screws 1210, 1211, the selection and assembly of the glenosphere 1212, 1213 and the orientation/impaction of the glenosphere 1214. One step 1216 related to the joint implant device is first to unpack the humeral tray components and verify the power and communication. Once unpacked, the humeral tray and body components are installed and assembled 1218, the humeral tray body being coupled with the humeral stem 102 by the second end 115. Then the joint implant device can be reduced. At this stage the features related to the body 105 can be used to start the measurements 1222 of the desired physical metrics, such as the contact force load and the center of load position and the height of the body 105. Another step 1224 is the change/adjustment of the height of the humeral tray body 105. The two steps 1222 and 1224 can be repeated. Finally, the surgical procedure is completed as normally for a reverse shoulder arthroplasty by repairing and adjusting the subscapularis and completing the surgery 1227, 1228. Steps 1222 and 1224 can eliminate the more complex techniques of removing the trail liner/cup (equivalent to 104) and the subjective evaluation of the joint laxity based on a case-by-case and practitioner-by practitioner basis.
[000127] In the present disclosure, a method of using the joint replacement system 1000 and to the implantable joint replacement device 100 is described in FIG. 10. This method of using the joint replacement system 1000 and to the implantable joint replacement device 100 can also encompass a method of evaluating, setting or balancing or a method to assist and help an operator
to evaluate, set or balance the implantable joint replacement device 100. For example, the joint replacement system 1000 and to the implantable joint replacement device 100 of the present disclosure can provide an operator, such as an orthopedic surgeon, with more objective and quantified data, such as contact load and center of load position data for an implantable joint replacement device 100, to help them evaluating the state in situ of the implantable joint replacement device 100. In the present disclosure and examples, the joint replacement system 1000 provides more accurately measured physical metrics related to the joint replacement device 100 and the surrounding environment, such as the contact load magnitude and center of load position in the joint replacement device 100, the thickness or height of the device body 105 of the joint replacement device 100, and/or the anatomical position of the shoulder/ arm system that receives the joint replacement device 100. The contact load magnitude and center of load position in the joint replacement device 100 are the main crucial physical metrics in the method since they are subjectively estimated intra-operatively and they can not estimate post-surgery. The continuous measurement or monitoring of the thickness or height of the device body 105 of the joint replacement device 100 or of the anatomical position of the shoulder/arm system is highly valuable to the proposed system and methods.
[000128] In the present disclosure, the use of the joint replacement system 1000, including the implantable joint replacement device 100, starts with the steps of installing a first joint replacement device component and a second joint replacement device component of the implantable joint replacement device 100 in a patient’s articular joint. These steps of installing a first joint replacement device component and a second joint replacement device component of the implantable joint replacement device 100 are surgical steps, and can avoid disrupting and alter the conventional workflow for the installation of an implantable joint replacement device of the same type. Once the components of the implantable joint replacement device 100, including the device body 105, are installed and in place within the joint, additional steps of the method can be launched being more specific to the joint replacement system 1000 and the implantable joint replacement device 100. These additional steps can include measuring, via a plurality of sensors in the device body, at least one physical metric related to the device body or to a portion of the device body, this physical metric being related to or applied onto the device body, and/or moving, via an external tool, a first end of the device body relative to a second end of the device body, wherein the relative moving changes the height of the body and changes the physical metric related to or applied onto said body, and/or displaying, via a data processing system, the physical metrics related to or applied onto the device body. Other additional steps can include receiving
and collecting, via the data processing system, data corresponding to anatomical position measured by external indicators installed on a limb or a portion of a limb, and/or interrelating or correlating, via the data processing system, measured data corresponding to physical metrics, height of the device body, and anatomical position of the limb, and/or rendering the values and representations of the data corresponding to height of the device body, and anatomical position of the limb. Some steps can be repeated as much as desired, for instance to reach measured physical metrics that can be considered as acceptable by the operator.
[000129] In the present disclosure, a method of using a joint replacement system is described. It comprises an implantable prosthetic joint replacement device with a first joint replacement device component and a second stemmed joint replacement device component being installed in an articulating joint of a human or mammalian body. It includes an expandable joint replacement device body that is installed coupled with the second stemmed component and between the said first component and second stemmed component. It comprises the steps of: -measuring, via a plurality of sensors located on one expanding member of said expandable device body, at least one physical metric being related to or applied onto said expanding member, and -moving, via an external tool, an expanding member of said expandable device body, said movement of said expanding member, wherein said movement is axial and trains a change of the height of the expandable device body of said joint replacement device, and -displaying or rendering, via a data processing system in a computing device, a representation of said physical metric related to or applied onto the expanding member of said expandable device body.
[000130] The method can include additional steps, presented below, that can be applied individually, concurrently, or independently. These additional steps can be selected among: - activating, via an external module, the plurality of sensors in the expanding member of said expandable device body, and -receiving and transmitting, via an external module, data corresponding to the physical metric detected by the plurality of sensors in the expanding member of said expandable device body, -measuring, via a plurality of indicators installed on a patient’s limb or a portion of the limb, data corresponding to the anatomical position of the patient’s limb or a portion of the limb, and collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s limb or a portion of the limb, and -relating, via the data processing system in a computing device, the data corresponding to said physical metric, said height of the body, and to said anatomical position of the limb, and rendering, via the data processing system in a computing device, a representation of
the data corresponding to said physical metric, said height of the body, and to said anatomical position of the limb. These steps of the method can be applied in a repeated way.
[000131] In the method, the plurality of sensors in the expanding member of the expandable device body can be activated by an external module, and this external module can receive and transmit the data corresponding to the physical metric detected by the plurality of sensors in the expanding member. The physical metric includes the contact load and center of load position applied onto the expandable device body and the height of the expandable device body. In this method, the implantable prosthetic joint replacement device is a shoulder arthroplasty device, and particularly a reverse shoulder arthroplasty device.
[000132] In the method, the height of the expandable device body can be increased or decreased, and the effect of the height of the expandable device body, and the change, on the physical metric applied onto the expanding member and expandable device body, such as the contact load and the center of load position, can be measured and displayed through a computing device and data processing system. This method can be applied to define a desired height of the expandable device body when installing an implantable prosthetic joint replacement device more objectively and quantitatively.
[000133] This method applies to an implantable prosthetic joint replacement device such as a shoulder arthroplasty device, and particularly a reverse shoulder arthroplasty device. Therefore, the second component can comprise at least one glenosphere, one baseplate and bone screws, and the stemmed component can basically comprise a humeral stem. The proximal humeral body can receive a socket or cup to contact with a sphere of said second component. The proposed method can apply to other types of joint replacement device, for example to devices for other joints and to other ball-and-socket (spheroid) joints such as hip. In the proposed method, the measured and displayed physical metric can include the contact load and center of load position applied on the proximal humeral device body of the shoulder arthroplasty device, and the height of the proximal humeral device body of the shoulder arthroplasty device.
[000134] In some embodiments, a shoulder arthroplasty system is proposed comprising an implantable reverse shoulder arthroplasty device having an installed first glenosphere component and an installed second humeral stemmed component, wherein an expandable proximal humeral body is coupled with said installed humeral stem component, and comprising the steps of measuring, via a plurality of sensors located on one expanding member of the proximal humeral
body, the load magnitude and center of load position being applied onto the expanding member, and displaying or rendering, via a data processing system in a computing device, a representation of the load magnitude and center of load position applied onto the expanding member of the expandable proximal humeral body. This method can be applied intra-operatively while a total or partial joint arthroplasty procedure but can also be applied to monitor post-operatively the performance of an implantable reverse shoulder arthroplasty device.
[000135] In the method, the method can comprise the additional step of moving, via an external tool, an expanding member of the expandable proximal humeral body, wherein this movement is axial and trains a change in height of the expandable proximal humeral body of the implantable reverse shoulder arthroplasty device. Also, it can include the additional step of activating, via an external module, the plurality of sensors in the expanding member of the expandable proximal humeral body. The method can include the additional step of receiving and transmitting, via an external module, data corresponding to the load magnitude and center of load position detected by the plurality of sensors in the expanding member of the expandable proximal humeral body.
[000136] In the method, additional steps on the method include measuring, via a plurality of indicators installed on the patient’s arm or a portion of the arm, data corresponding to the anatomical position of the patient’s arm or a portion of the arm, and collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s arm or a portion of the arm. Other additional steps of the method embody relating, via the data processing system in a computing device, the data corresponding to the load magnitude and center of load position, the height of the body, and to the anatomical position of the arm, and rendering, via the data processing system in a computing device, a representation of the data corresponding to the load magnitude and center of load position, the height of the body, and to the anatomical position of the arm. It is contemplated that the steps in the method, as described above, can be repeated as desired or needed.
[000137] In FIG. 14 shows a reverse shoulder arthroplasty device 100 being implanted in a human shoulder joint and incorporating an expandable proximal humeral body 105, where the expandable proximal humeral body 105 can be expanded or diminished in height by using an external adjusting tool 300. Once installed in the human shoulder joint, the change in height of the expandable proximal humeral body 105 can modify the lateralization of the implanted shoulder device and can impact the contact load and the center of load position that apply at the joint between the cup 104 and the glenosphere 101. Through the plurality of sensors and the
reporting and transmitting system, the expandable proximal humeral body 105 can measure and report the evolution of the contact load and the center of load position during the change in height of the expandable proximal humeral body 105. Such data are transmitted to the computing device and can be accessed through the user interface 1150. Therefore, the surgeon can intraoperatively change the height of the expandable proximal humeral body 105, and thus the lateralization of the device, for a given anatomical position or motion, and collect the resulting changes of the contact load and the center of load position in the shoulder joint.
[000138] FIG. 15A and FIG. 15B show an example of typical data that can be collected intraoperatively. FIG. 15A and FIG. 15B show the load magnitude and the load location (normalized) in relation to the height (thickness) of the expandable proximal humeral body 105 that were modified within a 6 mm range. FIG. 15A presents the load magnitude versus thickness relationship (Al) and the load location (normalized) versus the thickness relationship (A2) for an increasing thickness (height being increased from 0 to +6 mm) at an overhead reach position of the arm (arm at 90° of abduction and arm brought in external rotation to point the sky with the hand, 90° of external rotation). FIG. 15B presents the load magnitude versus thickness relationship (Bl) and the load location (normalized) versus the thickness relationship (B2) for a decreasing thickness (height being decreased from +6 mm to 0) at the same overhead reach position. The load position/location can be currently reported in polar coordinates by r radial coordinate) and O (angular coordinate, often called the polar angle). The determination of the load magnitude or location versus the device height or thickness relationship for a given anatomical position of the arm is an intrinsic part of the method proposed in the present disclosure. Similar curves for the load magnitude and the load location (normalized) in relation to the height (thickness) can be determined for any anatomical position.
[000139] The computing system(s) described herein can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., data packets) to a client device (e.g., for purposes of displaying data to or receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.
[000140] The separation of various system components does not require separation in all implementations, and the described program components can be included in a single hardware or software product. For example, the components described herein can be a single component, app, or program, or a logic device having one or more processing circuits, or executed by one or more processors of the data processing system(s).
[000141] Some of the description herein emphasizes the structural independence of the aspects of the system components. Other groupings or components that execute similar overall operations are understood to be within the scope of the present application. Modules or components can be implemented in hardware or as computer instructions on a non-transient computer readable storage medium, and modules can be distributed across various hardware or computer based components.
[000142] The systems described above can provide multiple ones of any or each of those components and these components can be provided on either a standalone system or on multiple instantiation in a distributed system. In addition, the systems and methods described above can be provided as one or more computer-readable programs or executable instructions embodied on or in one or more articles of manufacture. The article of manufacture can be cloud storage, a hard disk, a CD-ROM, a flash memory card, a PROM, a RAM, a ROM, or a magnetic tape. In general, the computer-readable programs can be implemented in any programming language, such as LISP, PERL, C, C++, C#, PROLOG, or in any byte code language such as JAVA. The software programs or executable instructions can be stored on or in one or more articles of manufacture as object code.
[000143] Example and non-limiting module implementation elements include sensors providing any value determined herein, sensors providing any value that is a precursor to a value determined herein, datalink or network hardware including communication chips, oscillating crystals, communication links, cables, twisted pair wiring, coaxial wiring, shielded wiring, transmitters, receivers, or transceivers, logic circuits, hard-wired logic circuits, reconfigurable logic circuits in a particular non-transient state configured according to the module specification, any actuator including at least an electrical, hydraulic, or pneumatic actuator, a solenoid, an opamp, analog control elements (springs, filters, integrators, adders, dividers, gain elements), or digital control elements.
[000144] The subject matter and the operations described herein can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. The subject matter described herein can be implemented as one or more computer programs, e.g., one or more circuits of computer program instructions, encoded on one or more computer storage media for execution by, or to control the operation of, data processing apparatuses. The program instructions can be encoded on an artificially generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus. A computer storage medium can be, or be included in, a computer- readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. While a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal. The computer storage medium can also be, or be included in, one or more separate components or media (e.g., multiple CDs, disks, or other storage devices include cloud storage). The operations described in this specification can be implemented as operations performed by a data processing apparatus on data stored on one or more computer-readable storage devices or received from other sources.
[000145] The terms “computing device”, “component” or “data processing apparatus” or the like encompass various apparatuses, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations of the foregoing. The apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). The apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them. The apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures.
[000146] A computer program (also known as a program, software, software application, app, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and can be deployed in any form,
including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program can correspond to a file in a file system. A computer program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
[000147] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatuses can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). Devices suitable for storing computer program instructions and data can include non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.
[000148] The subject matter described herein can be implemented in a computing system that includes a back end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front end component, e.g., a client computer having a graphical user interface or a web browser through which a user can interact with an implementation of the subject matter described in this specification, or a combination of one or more such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
[000149] While operations are depicted in the drawings in a particular order, such operations are not required to be performed in the particular order shown or in sequential order, and all
illustrated operations are not required to be performed. Actions described herein can be performed in a different order.
[000150] Having now described some illustrative implementations, it is apparent that the foregoing is illustrative and not limiting, having been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system elements, those acts and those elements may be combined in other ways to accomplish the same objectives. Acts, elements and features discussed in connection with one implementation are not intended to be excluded from a similar role in other implementations.
[000151] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including” “comprising” “having” “containing” “involving” “characterized by” “characterized in that” and variations thereof herein, is meant to encompass the items listed thereafter, equivalents thereof, and additional items, as well as alternate implementations consisting of the items listed thereafter exclusively. In one implementation, the systems and methods described herein consist of one, each combination of more than one, or all of the described elements, acts, or components.
[000152] Any references to implementations or elements or acts of the systems and methods herein referred to in the singular may also embrace implementations including a plurality of these elements, and any references in plural to any implementation or element or act herein may also embrace implementations including only a single element. References in the singular or plural form are not intended to limit the presently disclosed systems or methods, their components, acts, or elements to single or plural configurations. References to any act or element being based on any information, act or element may include implementations where the act or element is based at least in part on any information, act, or element.
[000153] Any implementation disclosed herein may be combined with any other implementation or embodiment, and references to “an implementation,” “some implementations,” “one implementation” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the implementation may be included in at least one implementation or embodiment. Such terms as used herein are not necessarily all referring to the same implementation. Any implementation may be combined with any other implementation, inclusively or exclusively, in any manner consistent with the aspects and implementations disclosed herein.
[000154] References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. References to at least one of a conjunctive list of terms may be construed as an inclusive OR to indicate any of a single, more than one, and all of the described terms. For example, a reference to “at least one of ‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and ‘B’. Such references used in conjunction with “comprising” or other open terminology can include additional items.
[000155] Where technical features in the drawings, detailed description or any claim are followed by reference signs, the reference signs have been included to increase the intelligibility of the drawings, detailed description, and claims. Accordingly, neither the reference signs nor their absence have any limiting effect on the scope of any claim elements.
[000156] Modifications of described elements and acts such as variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations can occur without materially departing from the teachings and advantages of the subject matter disclosed herein. For example, elements shown as integrally formed can be constructed of multiple parts or elements, the position of elements can be reversed or otherwise varied, and the nature or number of discrete elements or positions can be altered or varied. Other substitutions, modifications, changes and omissions can also be made in the design, operating conditions and arrangement of the disclosed elements and operations without departing from the scope of the present disclosure.
[000157] Systems and methods described herein may be embodied in other specific forms without departing from the characteristics thereof. For example, the joint implant device 100 can be implanted in a shoulder joint, a knee joint, an ankle joint, or a hip joint. Further relative parallel, perpendicular, vertical or other positioning or orientation descriptions include variations within +/-10% or +/-10 degrees of pure vertical, parallel or perpendicular positioning.
References to “approximately,” “about” “substantially” or other terms of degree include variations of +/- 10% from the given measurement, unit, or range unless explicitly indicated otherwise. Coupled elements can be electrically, mechanically, or physically coupled with one another directly or with intervening elements. Scope of the systems and methods described herein is thus indicated by the appended claims, rather than the foregoing description, and changes that come within the meaning and range of equivalency of the claims are embraced therein.
[000158] In this document, the terms "a" or "an" are used to include one or more than one, independent of any other instances or usages of "at least one" or "one or more." In this document, the term "or" is used to refer to a non-exclusive, unless otherwise indicated. In this document, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including", "incorporating" and "comprising" are open-ended, that is, a system, device, article, composition, formulation, method or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[000159] As used herein, the term "proximal" can mean closer to the heart and the term "distal" can mean more distant from the heart. The term "inferior" can mean lower or bottom and the term "superior" can mean upper or top. The term "anterior" can mean towards the front part of the body or the face and the term "posterior" can mean towards the back of the body. The term "medial" can mean toward the midline of the body and the term "lateral" can mean away from the midline of the body.
[000160] It is intended that the specification and examples be considered as exemplary only, with a true scope of the present disclosure being indicated by the following claims and their equivalents. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed systems and methods for measuring orthopedic parameters associated with a reconstructed joint in joint replacement or arthroplasty procedures. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the present disclosure.
Claims
1. An implantable prosthetic joint replacement device having multiple joint replacement device components, comprising: an expandable joint replacement device body to receive a first joint replacement device component, the expandable device body coupled with a second stemmed joint replacement device component, wherein: the expandable device body comprises an expanding member; the expanding member to support an articulating piece to contact with a second joint replacement device component; the expandable device body to expand axially via the expanding member to change a height of the expandable device body within a range from 0 to 10 millimeters; and the expanding member comprises a plurality of sensors to measure at least one physical metric applied to at least one of the expanding member or expandable device body.
2. The implantable device of claim 1, comprising: a basis member to couple with the second stemmed joint replacement device component; a rotating member to couple with the basis member of the expandable device body in a manner such that the rotating member is freely rotatable; and the rotating member and the expanding member are movably engaged through a plurality of corrugations or threads.
3. The implantable device of claim 2, wherein the rotating member comprises: a rack with a plurality of gear teeth at an outer circumferential portion, the rack to rotatably drive the rotating member; and wherein the driving of the rotating member results in a rotation of the rotating member and an axial movement of the expanding member relative to the basis member.
4. The implantable device of claim 3, wherein an external tool having a pinion gear-like end engages with the gear teeth of the rotating member to rotatably drive the rotating member.
5. The implantable device of claim 2, wherein the expandable device body is configured to reversibly lock the expanding member.
6. The implantable device of claim 5, wherein at least one element of the expanding member comprises: a rack with a plurality of gear teeth at an outer circumferential portion, wherein the element can be axially driven via an external tool having a pinion gear-like by engaging the gear teeth on the rack of the element; and wherein the driving results in the axial movement of the expanding member relative to said basis member.
7. The implantable device of claim 1, wherein the expanding member includes a closed internal module.
8. The implantable device of claim 7, wherein the plurality of sensors are coupled to a lower surface inside the closed internal module of the expanding member to withstand microdeformations and to detect load magnitude and orientation.
9. The implantable device of claim 7, wherein the closed internal module comprises electronic components including boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, or antennas.
10. The joint replacement device of claim 7, wherein: the expandable device body comprises an antenna outside the closed internal module; and the external antenna is communicably coupled with the electronic components inside the closed internal module.
11. The joint replacement device of claim 7, wherein the closed internal module is communicably coupled with an external module.
12. The implantable device of claim 9, wherein the plurality of sensors are communicably coupled to electronic components and circuitry in the internal module.
13. The implantable device of claim 1, wherein the sensors are selected among strain gauge sensors, thin foil and semiconductor strain gauge sensors, magnetometers, accelerometers, inductive-to-digital converter-based sensors, gyroscopes, geomagnetic sensors, potentiometers, resistive position transducers, resistive pressure transducers, and thermistors.
14. The joint replacement device of claim 1, wherein the at least one physical metric is one of deformation, force, load, position, distance, length, displacement, temperature, or humidity.
15. The joint replacement device of claim 1, wherein the implantable prosthetic joint replacement device is used to replace a ball-and-socket joint.
16. The joint replacement device of claim 1, wherein the first joint replacement device component comprises a ball or sphere or a glenosphere component.
17. The joint replacement device of claim 1, wherein the implantable prosthetic joint replacement device is a hip arthroplasty device or shoulder arthroplasty device.
18. The joint replacement device of claim 1, wherein the implantable prosthetic joint replacement device includes a reverse total shoulder arthroplasty device.
19. The join implantable device of claim 1, wherein at least one component of the expandable device body is composed of materials selected among rigid metals and alloys including chromium alloys, nickel alloys, stainless alloys, titanium alloys, plastics including polyethylene, ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and ceramics.
.0. An implantable reverse shoulder arthroplasty device, comprising:
a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component, the expandable proximal humeral body comprising an expanding member to support a humeral liner to receive the glenosphere component; the expandable proximal humeral body comprising a rotating member movably engaged, via a plurality of corrugations and threads, with the expanding member; the rotating member includes, at an outer circumferential portion, a rack with a plurality of gear teeth, the rotating member rotated by action on the rack and gear teeth of an external tool having a pinion-like end; the rotating member causes the expanding member to move axially and to a height of the expandable proximal humeral body within a range from 0 to 10 millimeters; and the expandable proximal humeral body includes a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect at least one physical metric applied to the expanding member via the humeral liner.
21. The implantable reverse shoulder arthroplasty device of claim 20, wherein the plurality of sensors is coupled with a lower surface of the expanding member to withstand microdeformations and to detect the load magnitude and orientation applied onto the expanding member via the humeral liner by the glenosphere component.
22. The implantable reverse shoulder arthroplasty device of claim 20, wherein the closed internal module comprises electronic components including boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, and antennas.
23. The implantable reverse shoulder arthroplasty device of claim 20, wherein: the expandable proximal humeral body comprises an antenna outside the closed internal module; and the external antenna is communicably coupled with the electronic components inside the closed internal module.
24. The implantable reverse shoulder arthroplasty device of claim 20, wherein the closed internal module is communicably coupled with an external module or hardware.
25. The implantable reverse shoulder arthroplasty device of claim 20, wherein the sensors are communicably coupled to electronic components and circuitry in the closed internal module.
26. The implantable reverse shoulder arthroplasty device of claim 20, wherein the sensors are selected among am accelerometers, magnetometer, gyroscope, geomagnetic sensor, potentiometer, resistive position transducer, resistive pressure transducer, thermistor, piezoresistive sensor, and strain gauge sensors, including thin foil and semiconductor strain gauge sensors.
27. The implantable reverse shoulder arthroplasty device of claim 20, wherein the at least one physical metric is one of deformation, load, force, magnitude, position, distance, length, displacement, temperature, or humidity.
28. The implantable reverse shoulder arthroplasty device of claim 20, wherein at least one component of the expandable proximal humeral body is composed of materials selected among rigid metals and alloys including chromium alloys, nickel alloys, stainless alloys, titanium alloys, plastics including polyethylene, ultra-high-molecular-weight polyethylene, polyether etherketone, polyurethanes, fluorinated polymers, copolymers, and ceramics.
29. The implantable reverse shoulder arthroplasty device of claim 20, wherein the expandable proximal humeral body comprises an antenna coupled with a member of the expandable proximal humeral body, and communicably coupled with the closed internal module.
30. A joint replacement system, comprising: an implantable prosthetic joint replacement device having multiple joint replacement device components and comprising an expandable joint replacement device body receiving a first joint replacement device component, the expandable device body coupled with a second stemmed joint replacement device component, wherein: the expandable device body comprises an expanding member to support an articulating piece to contact with the first joint replacement device component, and a rotating
member movably engaged, via a plurality of corrugations and threads, with the expanding member; the rotating member to be rotatably driven, via a rack with a plurality of gear teeth at an outer circumferential portion, by engaging the rack and gear-teeth with a pinion-like end of an external tool, to drive the expanding member into an axial movement to change a height of the expandable device body within a range from 0 to 10 millimeters; and the expanding member comprising a plurality of sensors coupled at a lower surface of the expanding member within a closed internal module of the expanding member to detect at least one physical metric applied to at least one of the expanding member or expandable device body; an external module or hardware to communicably couple with the closed internal module and the plurality of sensors; and a computing device to support a data processing system, receive the at least one physical metric, and to render graphical representation of the at least one physical metric.
31. The joint replacement system of claim 30, wherein the closed internal module comprises electronic components including boards and circuitry, wires and connectors, sensors, batteries, microcontroller units, communication units, transponders, tags, resistors, capacitors, memory units, or antennas.
32. The joint replacement system of claim 30, wherein the plurality of sensors comprises sensors selected among strain gauge sensors, thin foil and semiconductor strain gauge sensors, magnetometers, accelerometers, inductive-to-digital converter-based sensors, gyroscopes, geomagnetic sensors, potentiometers, resistive position transducers, resistive pressure transducers, and thermistors.
33. The joint replacement system of claim 30, wherein the at least one physical metric comprises at least one of deformation, load, force, magnitude, position, distance, length, displacement, temperature, or humidity.
34. The joint replacement system of claim 30, wherein at least one component is composed of materials selected among rigid metals and alloys including chromium alloys, nickel alloys,
stainless alloys, titanium alloys, plastics including polyethylene, ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and ceramics.
35. The joint replacement system of claim 30, wherein the joint replacement system comprises at least one external anatomical indicator system to determine the anatomical position of a limb in which the implantable prosthetic joint replacement device is installed.
36. The joint replacement system of claim 30, wherein the joint replacement system is configured to provide a quantitative assessment of a contact joint load and center of load position during the installation of the implantable joint replacement device or once the implantable joint replacement device is installed in a joint.
37. The joint replacement system of claim 36, wherein the joint replacement system is configured to measure and record the contact load and center of load position in the joint as a function of the height of the expandable device body of the system.
38. A shoulder arthroplasty system, comprising: an implantable reverse shoulder arthroplasty device having a humeral stem component coupled with an expandable proximal humeral body to receive a glenosphere component wherein: the expandable proximal humeral body comprises an expanding member to support a humeral liner to receive the glenosphere component; the expandable proximal humeral body comprises a rotating member movably engaged, via a plurality of corrugations and threads, with the expanding member; the rotating member includes, at an outer circumferential portion, a rack with a plurality of gear teeth and can be rotated by an action on the rack and gear teeth of an external tool having a pinion-like end; the rotating member causing the expanding member to move axially and to change a height of the expandable proximal humeral body within a range from 0 to 10 millimeters; the rotating member or the expanding member to be mechanically and reversibly locked in position; and
the expandable proximal humeral body comprises a plurality of sensors coupled with a lower surface of the expanding member within a closed internal module of the expanding member to detect at least one physical metric applied to the expanding member via the humeral liner; an external module or hardware to communicably couple with the closed internal and the plurality of sensors; and a computing device to support a data processing system, receive the at least one physical metric, and render a graphical representation of the at least one physical metric.
39. The shoulder arthroplasty system of claim 38, wherein the closed internal module comprises electronic components including boards and circuitry, wires, batteries, microcontroller units, communication units, memory units, or antennas.
40. The shoulder arthroplasty system of claim 38, wherein the plurality of sensors comprises sensors selected among strain gauge sensors, thin foil and semiconductor strain gauge sensors, magnetometers, accelerometers, inductive-to-digital converter-based sensors, gyroscopes, geomagnetic sensors, potentiometers, resistive position transducers, resistive pressure transducers, and thermistors.
41. The shoulder arthroplasty system of claim 38, wherein the at least one physical metric comprises at least one of deformation, load, force, magnitude, position, distance, length, displacement, temperature, or humidity.
42. The shoulder arthroplasty system of claim 38, wherein at least one component is composed of materials selected among rigid metals and alloys including chromium alloys, nickel alloys, stainless alloys, titanium alloys, plastics including polyethylene, ultra-high-molecular-weight polyethylene, polyetheretherketone, polyurethanes, fluorinated polymers, copolymers, and ceramics.
43. The shoulder arthroplasty system of claim 38, wherein the system comprises an external anatomical indicator system, including a position sensor, an inertial measurement unit sensor, or an optical indicator, to determine the anatomical position of a limb in which the implantable
reverse shoulder arthroplasty device is installed and to communicably couple with the computing device and the data processing system.
44. The shoulder arthroplasty system of claim 43, wherein the indicator system is installed on the limb.
45. The shoulder arthroplasty system of claim 38, wherein a joint replacement system is configured to provide a quantitative assessment of a contact joint load and center of load position during the installation of the implantable joint replacement device or once the implantable joint replacement device is installed in a joint.
46. The shoulder arthroplasty system of claim 38, wherein the joint replacement system is configured to measure and record the contact load and center of load position in the joint as a function of the height of the expandable device body of the system.
47. A method of using a joint replacement system comprising an implantable prosthetic joint replacement device having an installed first joint replacement device component and an installed second stemmed joint replacement device component, wherein an expandable joint replacement device body is coupled with the installed second stemmed joint replacement device component, comprising: measuring, via a plurality of sensors coupled on an expanding member of the expandable device body, at least one physical metric being applied onto the expanding member; moving, via an external tool, the expanding member of the expandable device body, wherein the movement is axial and causes a change of a height of the expandable device body of the joint replacement device; and rendering, via a data processing system of a computing device, a representation of the physical metric applied onto the expanding member of the expandable device body.
48. The method of claim 47, comprising activating, via an external module, the plurality of sensors in the expanding member of the expandable device body.
49. The method of claim 47, comprising transmitting, via an external module, data corresponding to the physical metric detected by the plurality of sensors in the expanding member of the expandable device body.
50. The method of claim 47, comprising relating, via the data processing system in a computing device, the data corresponding to the physical metric and the height of the body.
51. The method of claim 47, comprising: measuring, via a plurality of indicators installed on a patient’s limb, data corresponding to an anatomical position of the patient’s limb; collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s limb; and rendering, via the data processing system in a computing device, a representation of the data corresponding to the physical metric, the height of the body, and the anatomical position of the limb.
52. The method of claim 47, wherein the steps of the method can be repeated.
53. The method of claim 47, wherein the physical metric comprises a contact load and a center of a load position applied onto the expandable device body and the height of the expandable device body.
54. The method of claim 47, wherein the implantable prosthetic joint replacement device is a shoulder arthroplasty device.
55. The method of claim 47, wherein the method is configured to measure and record a joint contact load and a center of load position as a function of the height of the expandable device body in the joint replacement device.
56. A method of using a shoulder arthroplasty system comprising an implantable reverse shoulder arthroplasty device having an installed first glenosphere component and an installed second
humeral stemmed component, wherein an expandable proximal humeral body is coupled with the installed humeral stem component, comprising: measuring, via a plurality of sensors located on an expanding member of the proximal humeral body, a load magnitude and a center of load position being applied onto the expanding member; and rendering, via a data processing system in a computing device, a representation of the load magnitude and the center of load position applied onto the expanding member of the expandable proximal humeral body.
57. The method of claim 56, wherein the method is conducted intra-operatively during the course of a total or partial joint arthroplasty procedure.
58. The method of claim 56, wherein the method is configured to monitor post-operatively a performance of an implantable reverse shoulder arthroplasty device.
59. The method of claim 56, comprising: moving, via an external tool, an expanding member of the expandable proximal humeral body, wherein the movement is axial and causes a change in height of the expandable proximal humeral body of the implantable reverse shoulder arthroplasty device; and locking the expanding member in position.
60. The method of claim 56, comprising activating, via an external module, the plurality of sensors in the expanding member of the expandable proximal humeral body.
61. The method of claim 56, comprising transmitting, via an external module, data corresponding to the load magnitude and the center of load position detected by the plurality of sensors in the expanding member of the expandable proximal humeral body.
62. The method of claim 56, comprising: measuring, via a plurality of indicators installed on a patient’s arm, data corresponding to an anatomical position of the patient’s arm; and
collecting, via a data processing system in a computing device, the data corresponding to the anatomical position of the patient’s arm.
63. The method of claim 56, comprising: relating, via the data processing system in a computing device, the data corresponding to the load magnitude and center of load position, the height of the body; and rendering, via the data processing system in a computing device, a representation of the data corresponding to the load magnitude and center of load position, the height of the body.
64. The method of claim 56, wherein the steps of the method can be repeated.
65. The method of claim 56, wherein the method is configured to measure and record the load magnitude and the center of load position in the shoulder joint as a function of the height of the expandable proximal humeral body of the shoulder arthroplasty system.
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US202363520188P | 2023-08-17 | 2023-08-17 | |
US63/520,188 | 2023-08-17 |
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