Torque limiting connector device for use with osseointegration prosthetic limb systems

Abstract

The present invention relates to a torque connector device for an osseointegration prosthetic limb (OPL) system. The device features a body with a base portion that anchors and restrains movement, and includes a first spindle bushing positioned between the base and spindle release body to facilitate axial rotation. A second spindle bushing prevents unwanted pivoting of the first bushing. The spindle release body is centrally aligned to lock rotational alignment and connect the abutment assembly. A threaded connection between the base portion, calibration cap, and washers creates a locked state under normal conditions, maintaining stability across all axes. When torque exceeds a predetermined threshold, the first and second washers deform, disengaging the release pad and spindle release body, and allowing rotational movement to an unlocked state.

Description

TORQUE LIMITING CONNECTOR DEVICE FOR USE WITHOSSEOINTEGRATION PROSTHETIC LIMB SYSTEMSTECHNICAL FIELD

[0001] The present invention relates to connecting devices for use with implanted transcutaneous osseointegrated prosthetic limb systems. Specifically, the present invention relates to a Resettable Torque Connector (RTC) device (“connecter”) designed for linking external prosthetic limb components to implanted transcutaneous components of an Osseointegration Prosthetic Limb (OPL) system, employing a torque release mechanism that releases at specific torque values without using sacrificial components, to protect the bone / implant interface from torque induced injury, thereby improving device longevity and effectiveness.BACKGROUND

[0002] The following references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the following prior arts discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

[0003] Osseointegration (OI), also known as direct skeletal fixation (DSF), is the functional connection between ordered, living bone and the surface of a load-carrying implant. In the case of transcutaneous prosthetic limb systems, it involves fitting a titanium implant directly into the bone, allowing for an external prosthesis to be connected to it via transdermal components. This technique creates direct contact between living bone and the load-bearing implant, resulting in significantly stronger and more durable prosthetics. The benefits include increased prosthetic use, longer walking distances, better sitting comfort, stable and safer standing and walking.

[0004] Osseointegration surgery entails the insertion of a titanium implant into the remaining bone of an amputee. This implant serves as a direct anchor for an external prosthesis, eliminating the necessity for the amputee to rely on a conventional socketmounted prosthesis.

[0005] There are currently two primary types of osseointegration prosthetic limb systems available for amputees, one is a screw shape implanted prosthesis (OPRA) and the others are implanted press-fit prostheses.

[0006] OPRA uses a screw-shaped prosthesis design with a relatively short implant length within the body (e.g., 80 mm). On the other hand, press fit systems employ a press-fit prosthesis design featuring an alloy rod and a vacuum plasma sprayed porous surface structure with a longer implant length (e.g., 140-180 mm).

[0007] Osseointegration prosthetic limb systems are an advanced prosthetic limb solution that integrate osseointegration technology into their design. The systems surgically implant a titanium fixture directly into the residual bone of an amputee's limb, typically in the femur or tibia for lower limb amputations. This fixture serves as a secure anchor point for attaching the prosthetic limb, eliminating the need for a socket interface.

[0008] There are few connecting devices that integrate with the available Osseointegration Prosthetic Limb systems, the information of which is reproduced in the below paragraphs.

[0009] OPL-CC (Osseointegration Prosthetic Limb Clamp Connector) device- This device seamlessly integrates with the press-fit systems supplied by Osseointegration International and serves as the coupling link between the implant and prosthetic components like microprocessor knees and feet. Its torque release mechanism relies on a shear pin system, ensuring fail-safe protection against excessive torsional loads. The OPL-CC's torque release is set at 75±20Nm, with a total load limit consistent with other press-fit systems. The number torque releases prior to part replacement are 1 in number.

[0010] OPL-LLC (Osseointegration Prosthetic Limb Lower Limb Connector) System- Similar to the OPL-CC, the OPL-LLC system facilitates the connection between prosthetic components and the press-fit system supplied by Osseointegration International, offering fail-safe protection against excessive torsional loads through a shear pin mechanism. The torsion failsafe mechanism is designed to release at 100±20Nm. The number of torque releases prior to part replacement are 1 in number.

[0011] OPRA Axor II- This system offers a dual function aimed at protecting the OPRA Implant System from excessive loads. Its release mechanism is engineered to mitigate both bending and rotational forces, effectively safeguarding the implant during movement, especially when the prosthetic knee reaches its maximum flexion.

[0012] Additionally, the Axor provides a standardized connection to other prosthetic components, including the knee and foot. The OPRA Axor II distinguishes itself by its torque release mechanism, which notably does not rely on sacrificial components. However, its trigger point at 15Nm poses a significant drawback, as it risks unintended releases during normal daily activities, particularly impacting heavy weight patients and high impact activities.

[0013] GV 18- The GV Series Connector serves as a coupling interface for lower limb prosthetic fittings, bridging the gap between an osseointegrated intramedullary implant and standard commercial prostheses. This product is specifically designed for lower limb prosthetic fittings in conjunction with Femur or Tibia osseointegrated intramedullary implants. Its torque release mechanism is factory set at various levels ranging from 15Nm to 80Nm, providing flexibility to accommodate different user needs. Upon reaching a specific torque, the plastic ring deforms and clicks into the next set of teeth, allowing a controlled release of torque. This mechanism ensures reliable performance while offering a finite number of torque releases before the functionality of the component diminishes.

[0014] US20240148509A1 relates to a connection device for connecting an implant anchored in bone with an external prosthesis component, such as a limb prosthesis, prosthetic elbow or finger, includes a main housing, having a first attachment connectorportion for attachment to the implant system and a second attachment portion for attachment to the prosthesis component. The device further includes a safety mechanism to protect the implant system from high mechanical forces, including rotational forces or bending forces. The safety mechanism includes a rotational force release mechanism with a first component including a ring unit having an inner surface with at least one depression and a second component including at least one raised unit urged into contact with the recession by a fitting.

[0015] The conventional connectors necessitate sacrificial components for torque release, rendering them unusable after release and necessitating prosthetist intervention. In these connectors, threaded components are tightened with significant compressive force, making release challenging.

[0016] None of the devices / sy stems addresses both stability concerns and precise torque release requirements in osseointegration prosthetic limb systems.

[0017] To address these challenges, there is a need for a connecting device that efficiently and reliably releases at specified torque values (via the torque release mechanism) without using sacrificial components overcoming the issue of instability of users (wobbling).

[0018] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.SUMMARY

[0019] PROBLEMS TO BE SOLVED

[0020] It may be an advantage to provide a Resettable Torque Connector (RTC) device employing a torque release mechanism that releases torque values without sacrificial components.

[0021] It may be an advantage to provide a flexible connection between the Osseointegration Prosthetic Limb Implant Systems and external prosthetic components such as prosthetic knee and / or foot for normal ambulatory activities.

[0022] It may be an advantage to provide a connecting device that protects the subject from excessive torsional loads, such as those encountered during a fall, via a fail-safe mechanism.

[0023] It may be an advantage to provide a connecting device, wherein a high-performance engineering polymer, Polyamide-Imide has been used as a material to resist wear and plastic deformation and accordingly achieve an efficient torque release mechanism.

[0024] It may be an advantage to provide a connecting device that offers three different torque release versions 30 Nm, 50 Nm, 70 Nm each tailored with varying degrees of angularity to suit individual subject anatomy.

[0025] It may be an advantage to provide a connecting device that is able to overcome the problem of wobbling via the efficient torque release mechanism.

[0026] It may be an advantage to provide a connecting device that utilises washers that undergo elastic deformation during torque release to ensure greater consistency across torque release events.

[0027] It may be an advantage to provide a connecting device that is lightweight and has a short build height so it can fit cosmetically between the implant and the prosthesis.

[0028] It may be an advantage to provide a connecting device having a built-in release mechanism to protect the implant and the residual limb from uncommon high-torque events.

[0029] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.

[0030] MEANS FOR SOLVING THE PROBLEM

[0031] The present invention may be envisioned to be a connecter for linking prosthetic limb components to the transcutaneous components of osseointegration prosthetic limb systems, employing a torque release mechanism releasing at specific torque values.

[0032] In a first aspect of the present invention, the device comprises of a body which includes an array of components assembled together, including but limited to a base portion serving as the foundation of the connector system, a spindle release body designed to manage torque releases; first and second spindle bushings for providing smooth and consistent rotational movement; strategically positioned release pads facilitating controlled disengagement and re-engagement; first and second rings for sealing internal grease and protection against external elements; washers to optimize compression and functionality; screws for secure fastening and assembly; calibration caps for fine-tuning torque settings; a screw ring bolt for structural reinforcement, and calibration cap lock screws to maintain calibration integrity. Each component of the connecting device is intricately interlinked with others, forming a connector system.

[0033] In another aspect of the present invention, the base of the device is the primary connection point for the prosthetic limb. It not only securely anchors the limb but also effectively restrains the movement of several components including bushings, release body, release pads and washers, guaranteeing stability and accuracy during operation. Additionally, it seamlessly engages with the calibration cap through precisely machined mating threads. By tightening these threaded components together, the base generates the necessary compression to activate and calibrate the torque mechanism.

[0034] In another aspect of the present invention, the first washer provides a flat surface that ensures uniform force distribution between release pads and second washer.

[0035] In another aspect of the present invention, the second washer elastically deforms during torque release, enabling movement of the spindle release body without any plastic deformation, thereby ensuring the smooth operation and longevity of the connector system.

[0036] In another aspect of the present invention, the first spindle bushing functions as a low-friction bearing surface between spindle release body and base, facilitating smooth rotation during torque release. This component ensures that rotational movement between these elements occurs with consistent resistance.

[0037] In another aspect of the present invention, the second spindle bushing functions as a low-friction bearing surface between first spindle bushing and calibration cap. Additionally, this spindle bushing restricts the movement of the first spindle bushing to prevent unwanted pivoting.

[0038] In another aspect of the present invention, the spindle release body assembles with screws and ring bolts to establish the connection point for the abutment assembly, ensuring structural integrity and stability. Additionally, the spindle release body locks in rotational alignment with the screws and ring bolts and the abutment assembly, maintaining precise orientation.

[0039] In another aspect of the present invention, the release pad interfaces with the base portion in a predefined configuration, rotating together during torque release.

[0040] In another aspect of the present invention, the calibration cap lock screws that locks the base portion and calibration cap in position once the torque release value has been set.

[0041] In another aspect of the present invention, the threaded connection between components base portion, calibration cap and washers generate compression, effectively bringing together release pad and spindle release body which feature interfacing slots. This compression, coupled with the interfacing slots, establishes a connection that is locked in all three axes of movement under normal conditions.

[0042] In another aspect of the present invention, if a specified torque is applied to the device, the release pad and spindle release body are disengaged from each other, allowing rotation to occur.

[0043] In the context of the present invention, the words “comprise”, “comprising” and the like are to be construed in their inclusive, as opposed to their exclusive, sense, that is in the sense of “including, but not limited to”.

[0044] The invention is to be interpreted with reference to the at least one of the technical problems described or affiliated with the background art of the invention. The present aims to solve or ameliorate at least one of the technical problems and this may result in one or more advantageous effects as defined by this specification and described in detail.BRIEF DESCRIPTION OF THE FIGURESFigure 1 is an illustration and perspective view of the existing OPL-CC (Osseo integration Prosthetic Limb Clamp Connector) System;Figure 2 is an illustration and perspective view of the existing OPL-LLC (Osseointegration Prosthetic Limb Lower Limb Connector) System;Figure 3 is an illustration and perspective view of the existing OPRA Axor II system;Figure 4 is an illustration and perspective view of the existing GV 18 Series Connector;Figure 5 depicts an exploded view of the present device, according to an exemplary embodiment of the present invention;Figure 6 illustrates a detailed architectural diagram of the present device, according to a preferred embodiment of the present invention;Figure 7 illustrates the neutral, left and right angular alignment views of the present device;Figure 8 illustrates the connection between Resettable Torque Connector (RTC) with a taper sleeve and lock screw;Figure 9a, 9b and 9c illustrates schematic view of the taper sleeve protector, 5mm Hex L wrench and a reset tool; andFigure 10 illustrates an exploded view of the grub screw mechanism.DESCRIPTION OF THE INVENTION

[0045] Preferred embodiments of the invention will now be described with reference to the accompanying drawings and non-limiting examples.

[0046] The term “spindle bushing” refers to a cylindrical sleeve or bearing used in mechanical assemblies to enable smooth and low-friction rotation of a spindle or shaft within another component. It reduces friction and wear, ensuring efficient and reliable operation in various machinery and equipment applications.

[0047] The term “grub screw” refers to a set screw which is a type of fastener that is threaded along its entire length and lacks a conventional head.

[0048] The term “grub bolt” refers to a type of grub screw but typically longer and may have a larger diameter.

[0049] The term “Belleville washer” refers to a conically shaped washer designed to be loaded axially. It is used to apply a controlled amount of tension or preload to a bolted joint or assembly. Belleville washers are commonly used as spring elements in bolted joints, clamping mechanisms, and applications requiring controlled preload and flexibility under varying loads and conditions.

[0050] The term “interfacing slots” refer to specific grooves, channels, or slots designed into a component where other parts or elements can securely fit or engage.

[0051] The term “subject” refers to the individual patients.

[0052] The term “sacrificial components" refer to elements within a system or device that are designed to degrade, wear out, or be consumed over time in order to protect more critical or expensive parts from damage or excessive wear.

[0053] The term "angularity" likely refers to the angular displacement or alignment angle at which the mechanism operates or releases torque. In the context of medical or anatomical devices, these torque settings could correspond to different levels of force required based on the anatomical structure or condition being addressed.

[0054] Figures 1 through 4 describes the prior art.

[0055] Figure 1 illustrates the design of the existing Osseointegration Prosthetic Limb Clamp Connector (OPL-CC) device. This device is an essential component of the Osseointegration International OPL Implant System, designed to seamlessly integrate with modular prosthetic limb components such as knees and feet. Its primary function is to establish a secure connection between these components and the transcutaneous part of osseointegrated systems already implanted in the lower limbs of amputees. This innovative device supports everyday activities while ensuring patient safety through a fail-safe mechanism that protects against excessive torsional loads during falls. The OPL-CC System is engineered to withstand up to 125 kg under regular usage conditions and up to 110 kg during active use, with a built-in torque release mechanism that triggers at a precise 75 Nm ± 10 Nm, followed by controlled rotation limits to safeguard users' mobility.

[0056] The OPL-CC is specifically indicated for amputees who meet certain criteria, including a body weight under 110 kg and a maximum offset of 60 mm between the implant and prosthetic limb. It is crucial that users have sufficient upper limb strength or dexterity to operate the connector effectively. The device features a robust design with a build height of approximately 12 mm from the distal end of the Dual Cone, optimizing functionality while maintaining a compact profile. With an intended service life of 2 years, the CC System incorporates a shear pin-based torque release mechanism that ensures reliable performance and longevity. This combination of durability, safety features, and ease of usemakes the OPL-CC a vital component in enhancing the mobility and quality of life for osseointegrated prosthetic limb users

[0057] Figure 2 illustrates view of the existing OPL-LLC (Osseointegration Prosthetic Limb Lower Limb Connector) System. This system is quite similar to Osseointegration Prosthetic Limb (OPL) Clamp Connector (CC) System. This system features a torsion failsafe mechanism designed to release at 100±20 Nm, ensuring operational safety. It supports a total load limit of 150 kg under regular conditions, with 110 kg approved for active use scenarios. The maximum allowable offset between implant and prosthesis is 60 mm, facilitating flexibility in alignment. The build height extends approximately 10 mm from the distal end of the Dual Cone Adaptor, optimizing functionality.

[0058] Figure 3 illustrates view of the existing OPRA Axor II System. The Axor serves a dual function in the OPRA Implant System: first, it safeguards against excessive loads by incorporating a release mechanism for both bending and rotational forces. Specifically, it limits rotational forces along the implant's centerline and bending forces when the prosthetic knee reaches maximum flexion. Additionally, the Axor features a standard connection compatible with other prosthetic components, including knees and feet, utilizing a European 4-hole male / female mounting system. This standardized connection enables integration with various prosthetic systems. The OPRA System is recommended for use with both non-microprocessor controlled and certain microprocessor controlled prosthetic knees, excluding those requiring powered flexion activation and necessitating sufficient upper limb strength and dexterity for proper connector operation.

[0059] Key criteria for suitability include patients under 70 years old, transfemoral amputees struggling with conventional socket prostheses, and those meeting specific anatomical and medical criteria such as skeletal maturity, normal anatomy, body weight under 100 kg, and ability to comply with rehabilitation and follow-up protocols. The device requires a recommended distance of 200 mm to external prosthetic components and is designed with a build height of approximately 10 mm from the distal end of the Dual Cone Adaptor. Its torsion release mechanism operates at a factory setting of 15 ± 2 Nm, with abending release setting at 70 ± 5 Nm, ensuring operational safety and reliability over its 2- year service life.

[0060] Figure 4 illustrates the GV 18 connecter. The GV Series Connector serves as an interface for lower limb prosthetics, connecting an osseointegrated intramedullary implant to a standard commercial prosthesis. Designed to enhance mobility for amputee patients, it extends the artificial limb seamlessly. Proximally, the connector attaches to the taper sleeve / anti-rotation locking washer assembly of the Osseointegrated implant system. Distally, it features a standard connection with four threaded holes commonly used in the prosthetic industry, enabling integration with standard leg prostheses.

[0061] This connector is intended exclusively for lower limb prosthetic fittings in conjunction with Femur or Tibia osseointegrated intramedullary implants. It is suitable for patients weighing under 110 kg and those requiring less than 60 mm of offset between the implant and prosthesis, with sufficient upper limb strength and dexterity for proper operation. The device operates with torque release settings at 15 Nm, 25 Nm, 35 Nm, 50 Nm, 65 Nm, and 80 Nm. It offers a service life of 3 years, while the Torque Ring and rotation ring have service durations of 6 months each or up to 3 safety disengagements for the Torque Ring.

[0062] The GV 18 Torque Mechanism employs plastic deformation for torque release, ensuring durability with a finite number of releases before functional loss. It features a plastic ring that interlocks with metal teeth, clicking into the next set upon reaching a specific torque threshold.

[0063] The present invention is a connecter for linking prosthetic limb components to the transcutaneous components of OPL system, employing a torque release mechanism releasing torque values. The device uses Polyamide-Imide as a material to resist plastic deformation and accordingly achieve an efficient torque release mechanism.

[0064] The connector device represents a significant technological advancement with broad applications across diverse industries including but not limited to medical andhealthcare; orthopaedics surgeries and treatments; rehabilitation of amputees; biomedical engineering for testing and refining osseointegration techniques and prosthetic limb design and prosthetics and rehabilitation engineering.

[0065] One of the significant features of the device is its built-in release mechanism, specifically engineered to protect the implant and the residual limb from uncommon high- torque events, such as those experienced during a stumble, fall, or high-impact activity.

[0066] This mechanism activates under excessive torque conditions, safely disconnecting the prosthesis to prevent damage and potential injury. Importantly, the release mechanism is resettable, allowing patients or prosthetists to quickly reattach the prosthesis and restore its functionality.

[0067] The users of this device are prosthetists and subjects who have been fitted with transdermal intramedullary osseointegration stems.

[0068] Additionally, with the potential for the abutment to be installed immediately following initial osseointegration surgery, orthopaedic surgeons may also become key users of this device.

[0069] In Figure 5, an exploded view of the connector according to the present invention is shown, according to one embodiment.

[0070] A Torque Connector includes the following elements namely a base portion 1; a spindle release body 3; first and second spindle bushings 2, 4 ; release pads 5 and second rings for sealing and protection against external elements; rings 8,9; washers 6,7, 15 to optimize compression and functionality; at least two screws 11, 12; calibration cap 10; a screw ring bolt 13; calibration cap lock screw 14 to maintain calibration integrity.

[0071] The base portion 1 anchors the device assembly providing robust structural support at the device's lower end. Directly above the base portion 1 is the lower spindle bushing 2 that interfaces closely with the inner surface of the base portion, facilitating smoothrotational movement. Moving upwards, there is the spindle release body 3 that fits snugly onto the lower spindle bushing 2, serving as a pivotal component in the torque release mechanism. On top of the spindle release body 3, there are stacked release pads 5 arranged strategically. These pads are designed to ensure that the device can release or engage smoothly and precisely during its operation.

[0072] Furthermore, there are washers 6, 7 meticulously placed over the release pads, optimizing compression and enhancing operational efficiency. The assembly progresses with the addition of a sealing and protective outer ring 8, crucial for shielding against external and maintaining internal integrity. There is an upper washer 15 securely linked to the upper spindle bushing 4, reinforcing stability and structural coherence. An inner O- ring 9 is integrated next, providing essential sealing to prevent fluid leakage and contamination. To finalize the assembly, a calibration cap 10, a grub screw 11 and grub screw bolt 12 are meticulously positioned, securing the entire configuration and allowing for precise adjustment and calibration as needed.

[0073] In Figure 6, an architectural diagrammatic view of the connector according to the present invention is shown, according to one embodiment.

[0074] The base portion 1 of the device serves as the primary anchor point for the prosthetic limb, ensuring both secure attachment and stable operation. It plays a crucial role in stabilizing various components such as bushings, the release body, release pads, and washers, thereby guaranteeing operational stability and accuracy.

[0075] Additionally, the base portion seamlessly engages with the calibration cap through precisely machined threads. When these components are tightened together, they generate the necessary compression to activate and finely calibrate the torque mechanism.

[0076] A flat washer 6, positioned beneath the threaded interface of the base portion and the calibration cap, applies controlled force to compress the release pad 5 and spindle release body 3, establishing a precise torque release value.

[0077] The Belleville washer 7 is a cone shaped washer, situated between the flat washer 6 and an upper washer 15, undergoes elastic deformation during torque release. This deformation allows the spindle release body 3 to move without permanent distortion, acting effectively as a torque limiter to apply or release torque at predetermined thresholds.

[0078] Both washers 6,7 may be circular or disc-shaped with concentric ridges on their surfaces to enhance grip and stability.

[0079] The device incorporates approximately two Belleville washers 7 in its design.

[0080] The device incorporates two types of cylindrical bushings, first spindle bushing and second spindle bushing. These bushings feature an inner surface meticulously crafted to snugly fit around the spindle or shaft, ensuring a secure and precise connection. Simultaneously, their outer surface interfaces seamlessly with surrounding components, facilitating smooth operation and maintaining structural integrity within the device.

[0081] The lower spindle bushing 2 functions as a low-friction bearing surface between the spindle release body 3 and the base portion 1 , ensuring smooth rotation during torque release. This component minimizes resistance and friction during rotational movements.

[0082] Furthermore, the upper spindle bushing 4 serves as a similar low-friction bearing surface between the lower spindle bushing 2 and the calibration cap 10. It not only facilitates smooth rotational movement but also prevents unintended pivoting by restricting the lower spindle bushing 2 movement.

[0083] The spindle release body 3 centrally aligned within the device is a connection point for assembling the components of the abutment assembly. It securely locks the rotational alignment of the spindle release body 3 within the device, ensuring stability and precision.

[0084] The spindle release body 3 is assembled using screws 12 and ring bolts 13 to establish a robust connection point for the abutment assembly.

[0085] Moreover, the spindle release body 3 locks into precise rotational alignment with the screws 12, ring bolts 13, and the abutment assembly, maintaining accurate orientation throughout operation.

[0086] Within the abutment assembly, key components include a grub screw 12 for securing parts together, a ring-shaped screw ring 11 that interfaces with the screw 12 , and a specialized ring bolt 13 designed to complement and interact with both the screw 12 and screw ring 11.

[0087] The grub screw 12 should be tightened with an L Wrench 18. The torque of the replacement ring bolt 13 may be 15Nm.

[0088] Figure 10 illustrates the assembly process of the grub screw 12, wherein the connector 20 is brought into alignment with the taper sleeve 16. A critical step in this alignment involves orienting a pocket strategically located on the taper sleeve 16 to coincide with a grub screw 12 extending from the connector 20. Once this alignment is achieved, the connector 20 and taper sleeve 16 are pressed together until they are fully seated. This condition is visually indicated by the top surface of the connector 20 becoming flush with the top surface of the taper sleeve 16, ensuring proper mechanical interface. The grub screw 12 is hand-tightened utilizing a standard 5mm hex driver 18.

[0089] Upon proper fixing, the grub screw 12 is hand-tightened utilizing a standard 5mm hex driver 18. As the grub screw 12 is tightened, its distal end directly engages and seats within the aforementioned pocket on the Taper Sleeve 16. This engagement creates a positive mechanical interlock, effectively locking the connector 20 to the Taper Sleeve 16. The securement provided by this grub screw 12 engagement ensures a stable and reliable connection for a prosthesis.

[0090] For the purpose of disconnection or removal of the prosthesis via the connector, the grub screw 12 is simply loosened. Specifically, rotating the grub screw 12 counterclockwise by approximately one full rotation is sufficient to disengage it from the pocketon the Taper Sleeve. This disengagement releases the mechanical interlock, thereby allowing the connector and the Taper Sleeve components to be readily separated.

[0091] The release pad 5 is designed to handle torque of variants 30 Nm, 50 Nm and 70 Nm respectively. These pads are strategically positioned within the device to interact with other key components such as the base portion 1 or spindle body 3.

[0092] Their primary function is to facilitate controlled rotation during torque release events, ensuring that torque is released in a predictable manner.

[0093] The release pads 5 can vary in shape and configuration to suit different torque requirements and operational conditions. They may feature circular or disc-shaped profiles to evenly distribute torque forces, or they might have flat surfaces or contoured profiles for specific applications.

[0094] Furthermore, the interface slots on the spindle body 3 play a crucial role in ensuring precise alignment and secure attachment of washers 6,7, 15 the abutment and other components.

[0095] There are slots on the release pads 5 to regulate their movement during torque application. This feature enables controlled and predictable release actions, enhancing the device's reliability and performance in torque-sensitive applications.

[0096] The device incorporates a torque release mechanism wherein the application of force from conical washer 7, compressed by the calibration cap 10 provides precise compression. A flat washer 6 is utilized to evenly distribute the load from the conical (Belleville) washers over the bushing, ensuring uniform pressure distribution. This setup facilitates the setting of the release pad 5 and spindle release body 3 to achieve a predetermined torque release value.

[0097] Additionally, the specialized washer 7 is employed to undergo elastic deformation, enabling controlled movement or disengagement of the release pad when the specified torque threshold is reached.

[0098] There is a threaded connection between the base portion 1, calibration cap 10, and washers 6,7, wherein the connection serves two distinct states: a locked state and an unlocked state.

[0099] In the locked state, when the applied torque remains below a predetermined threshold, deformation occurs in the flat washer 6 and washer 7. The compressive force exerted by the flat washer 6 maintains a secure connection among the release pad 5, spindle release body 3, and components of the abutment assembly in all three axes of movement under normal conditions, ensuring stability.

[0100] On the other hand, when the applied torque exceeds a certain limit, the washers deform, entering the unlocked state. This deformation leads to the washer 7 releasing tension, thereby allowing controlled movement or disengagement of the release pad 5 and spindle release body 3 respectively.

[0101] The torque release mechanism defines the device's capability to manage torque effectively, by transitioning between locked and unlocked states based on applied torque levels.

[0102] The torque connector may be available in a total of 9 distinct versions, stemming from combinations of 3 different base designs and 3 different torque release settings.

[0103] Base Designs (Angular Alignment): The RTC features three built-in options for angled prosthetic mounts, which relate to the orientation of the base portion. These base designs dictate the angular alignment relative to the subject's anatomy.

[0104] Neutral (0°): This base design provides a straight or 0-degree angular alignment for the prosthetic mount. It is suitable when no rotational offset is required between the implant and the external prosthesis.

[0105] Left (6°): This base design provides a 6-degree angular alignment to the left. It is selected to accommodate specific patient gait or anatomical requirements, allowing for a precise angular orientation of the prosthesis.

[0106] Right (6°): This base design provides a 6-degree angular alignment to the right. Similar to the left option, it is chosen to achieve the correct alignment based on the subjects anatomy.

[0107] Each of the three base designs may be manufactured with one of the three pre-set torque release values. These settings are tailored to provide varying degrees of protection against excessive torsional loads and preventing damage to the bone / implant interface and residual limb.

[0108] The mechanism offers three different torque release versions 30 Nm, 50 Nm, 70 Nm each tailored with varying degrees of angularity to restore subject anatomy. This has been recited in Figure 7 and also in Table 1 reproduced below :Table 1

[0109] This table provides an overview of the torque release values across different alignment positions. This device offers nine distinct variants tailored to specific torque and angular configurations. Among these variants are three configurations set at a 0-degree base torque, available at 30, 50, and 70 Nm respectively. Additionally, the device features variants with a +6-degree base torque at 30, 50, and 70 Nm, as well as counterparts with a -6-degree base torque configuration at the same torque levels.

[0110] It depicts that regardless of the alignment (Neutral, Left, or Right), the torque release values are consistently maintained at 30 Nm, 50 Nm, and 70 Nm, demonstrating the device's capability to deliver precise torque settings across various operational conditions. This uniformity ensures predictable and reliable torque application regardless of the device's position.

[0111] In clinical practice, subjects initially start with the 30Nm torque release variant of the device, designed to provide a balance between stability and functional flexibility. This setting is chosen based on standard clinical protocols and initial assessment of the subjects activity levels and physiological condition. This stepwise progression — from 30Nm to potentially 50Nm or 70Nm — aims to enhance subject comfort and confidence in performing daily activities. By adjusting the torque release setting to better accommodate the subject functional demands, clinicians can mitigate the inconvenience caused by frequent activations of the release mechanism.

[0112] The highest available torque release setting, 70Nm, represents a carefully considered upper limit. Approaching the theoretical bone / implant interface limit of lOONm, this setting ensures that subjects can safely engage in a broad range of activities without compromising the integrity of the device or the implant site.

[0113] Apart from the above components, the device also includes calibration caps 10, calibration cap screws 14, grub screws 11, grub screw ring 12 and grub screw ring bolts 13 amongst others.

[0114] The calibration cap 10 effectively immobilizes components 2, 3, 4, 5, 6, 7, 8, and 9, ensuring their stability within the device. It connects to the base portion 1 via threaded mating, and tightening these components together applies the necessary compression to enable the torque mechanism's operation and calibration.

[0115] During calibration, the process precisely regulates the movement of the spindle release body 3 and release pads 5 in response to applied torque, preventing undesired slippage or rotation.

[0116] Calibration is finalized by securing the calibration cap screw 14, which locks the base portion 1 and calibration cap 10 into a fixed position once the desired torque release value is set. This step ensures the integrity of the calibration over time.

[0117] The device is equipped with at least two calibration cap lock screws 14.

[0118] In one of the embodiments of the present invention, the lock screw employed is standardized with an Ml 2 thread and requires a 5mm hex key for adjustment. This uniformity ensures simplicity and ease of use in securing components within the device. This lock screw secures the abutment / taper sleeve to the transcutaneous component attached to the subject.

[0119] The lock screw may be made up of Cobalt-chromium (CoCrMo) and have a torque of about 20 Nm.

[0120] Additionally, as illustrated in Figures 8, 9a, 9b and 9c the connecter 20includes taper sleeve protector 17, a 5mm Hex L Wrench 18, and a reset tool 19. The connecter 20 is designed to connect to the Transdermal compress via a taper sleeve 16.

[0121] This sleeve 16 is engineered to be secured to the transdermal compress using a taper connection, further fastened by a lock screw.

[0122] The taper sleeve 16 is a modular, replaceable component that connects to the implant and is secured with a lock screw.

[0123] The Taper Sleeve Protector 17 is used for Taper Sleeve installation and for protection of the Taper Sleeve 16 when the RTC20 is not attached.

[0124] The taper sleeve 16 is available in a single size but offers ten variations distinguished by the alignment of distal slots. These variations are tailored to accommodate different rotational implant offsets, allowing for precise customization and optimal fit of the device according to individual subject needs. The distinct versions provide a crucial interface for the torque connector.

[0125] These sleeves accommodate a precise range of correction, with increments of 7.5 degrees spanning from -30 degrees to +30 degrees. Each subject is fitted with a single, specific taper sleeve, ensuring optimal alignment and a secure connection for the prosthetic component.

[0126] The transdermal compress is recommended for use with microprocessor- controlled prosthetic knees or those offering similar stance stability control. However, other types of prosthetic knees, such as mechanical, hydraulic, or pneumatic knees, are permissible if deemed necessary. The use of prosthetic knees that feature powered activation of flexion and extension is restricted.

[0127] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein.

[0128] The present invention and the described preferred embodiments specifically include at least one feature that is industrial applicable.Referral Numerals List1- Base Portion2- Lower Spindle Bushing3- Spindle Release Body4- Upper Spindle Bushing5- Release Pads6- Flat Washer7- Belleville Washer8- Outer Ring9- Inner Ring10- Calibration Cap11 - Grub Screw Ring12- Grub Screw13 - Grube Screw Ring Bolt14- Calibration Cap Lock Screw15- Upper Washer16- Taper Sleeve17- Taper Sleeve Protector18- L Wrench19- Reset Tool20- Connector

Claims

Claims:

1. A torque connector device for an osseointegration prosthetic limb (OPL) system; comprising: a body consisting of an array of components assembled together, wherein the body comprises; a base portion as the primary connection point for the prosthetic limb, securely anchoring and restraining movement of the components of the device; a first spindle bushing positioned between a spindle release body and the base portion for facilitating axial rotation of the spindle release body relative to the base portion; a second spindle bushing arranged between first spindle bushing and a calibration cap, wherein the second bushing prevents unwanted pivoting of the first spindle bushing within the device; a spindle release body aligned centrally within the device, wherein the body establish a connection point to assemble the components of the abutment assembly and locks the rotational alignment of the spindle release body within the device; a threaded connection between the base portion, calibration cap, and washers, wherein the connection generates compressive force and coupled with interfacing slots establishes a locked connection in all three axes of movement under normal conditions, maintaining a locked state; wherein application of a torque release above a predetermined threshold causes deformation of the first and second washers, disengaging the release pad and spindle release body and allowing rotational movement, defining an unlocked state.

2. The device of Claim 1 , wherein the device provides three torque release settings of 30 Nm, 50 Nm, and 70 Nm that can be applied at different angles relative to the subject's anatomy using a lock screw.

3. The device of Claim 1, wherein the first washer is the flat washer, second washer is the Belleville Washer which is cone-shaped and the third washer is the flat upper washer.

4. The device of Claim 1 or Claim 3, wherein the Belleville washers apply a specific amount of force to allow torque release at a predetermined value and act as torque limiters.

5. The device of Claim 1, wherein the first and second washers are circular or discshaped with concentric ridges present on their surface.

6. The device of Claim 1, wherein the first spindle bushing is the lower spindle bushing and the second spindle bushing is the upper spindle bushing.

7. The device of Claim 1 or 6, wherein the bushings are cylindrical in shape.

8. The device of Claim 1 or 6 or 7, wherein bushing includes an inner surface that fits closely around the spindle or shaft and an outer surface that interfaces with the surrounding components.

9. The device of Claim 1, wherein the device further includes a calibration cap screw that locks the base portion and calibration cap in a specific position once the torque release value has been set to a predetermined value.

10. The device of Claim 1, wherein the material within the device that resists plastic deformation is Polyamide-Imide.

11. The device of Claim 1, wherein the device includes an outer and an inner ring, both circular in shape that prevent liquid form entering the inner portion of the device.

12. The device of Claim 1 , wherein the device includes a screw to fasten or secure parts together; screw ring which is a ring-shaped component that interacts with the screw and a ring bolt designed to fit with the screw and screw ring which are coupled to the abutment assembly.

13. The device of Claim 1, wherein the device includes release pads that is a circular disc with either a flat profile or contoured profile.

14. The device of Claim 1, wherein the interfacing slots on the spindle body ensure precise alignment and secure engagement of washers and other components, maintaining torque settings,15. The device of Claim 1, wherein the interfacing slots on the release pads control their movement during torque application to facilitate controlled release.

16. The device of Claim 1, wherein the abutment assembly consists of a taper sleeve and the Ml 2 lock screw.

17. A connector device, comprising a torque release mechanism, further consisting; a first washer compresses a release pad and the spindle release body to establish a predetermined torque release value; a second washer to elastically deform and facilitate controlled movement or disengagement of the release pad upon application of a specified torque;a threaded connection between the base portion, calibration cap, and washers, wherein the connection established two states including; a locked state, wherein specific torque applied to the threaded connection is below the predetermined threshold and the first and second washers experience minimal deformation; compressive force exerted by the first washer maintains a tight connection between the release pad, spindle release body, and components of the abutment assembly; and an unlocked state, wherein specified torque applied exceeds the predetermined threshold; deformation of the first and second washers occurs, causing the second washer to release tension and allowing controlled movement or disengagement of the release pad and spindle release body respectively.

18. The device of Claim 17, wherein device includes at least one screw ring bolt adapted to provide structural reinforcement.

19. The device of Claim 17 or 18, wherein the ring bolt is circular in shape.

20. The device of Claim 17, wherein device includes at least two calibration cap lock screws adapted to maintain calibration integrity.

21. The device of Claim 17, wherein the calibration process controls the slippage or rotation of spindle release body and the release pads under applied torque.

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