Design of Total Elbow Arthroplasty and Fabrication by Digital Light Processing

Abstract

Total elbow arthroplasty (TEA) is an important treatment for people with severe elbow joint problems. Traditional designs frequently confront issues with fit, durability, and postoperative recuperation. The objective of the present invention is to redesign Total Elbow Arthroplasty (TEA) implants to reduce the high incidence of complications such as aseptic loosening, periprosthetic fractures, and infections, which often necessitate revision surgeries.

Specification

Description:FIELD OF INVENTION
The present invention generally relates to orthopaedic surgery. More specifically the invention describes the design and fabrication of total elbow arthroplasty by digital light processing.
BACKGROUND OF THE INVENTION
Total elbow arthroplasty is a frequent surgical treatment used to treat severe rheumatoid arthritis, posttraumatic arthritis, osteoarthritis, and unfixable fractures in elderly individuals.
A surgical treatment used to replace damaged joint surfaces in the elbow, typically due to severe arthritis. An incision is created to gain access to the joint, and worn surfaces are removed. The artificial stem components are subsequently glued into the ulna and humerus canals. The components fit together, forming a metal and plastic hinge at the connection. When all of the components are installed, the elbow is inspected to ensure proper range of motion, alignment, and stability.
Total elbow prostheses have changed over time, and currently include linked, unlinked, and convertible options. The associated complication rates are also significant, at 19.1% for linked TEAs and 26.5% for unlinked TEAs.5 Long-term problems, including as infection, aseptic loosening, instability, and periprosthetic fracture, remain a concern.
While TEA is a versatile treatment that can be performed in both elective and trauma circumstances, the implant's weight-bearing capabilities limits its utilization. Other difficulties, such as limited medullary canals, osteoporotic bone, and extensor mechanism restoration, contribute to the technical difficulty.
A Scientific literature titled "Posterior Flange Cyclic Loading in a Novel Total Elbow Arthroplasty", [Gibbs, et al., May 2023] this study was to test the static and dynamic strength and loosening resistance of the posterior flange of a novel total elbow arthroplasty. They also examined the forces experienced by the ulnohumeral joint and the posterior olecranon during expected elbow use.
Another scientific literature titled "Total elbow arthroplasty in patients with rheumatoid arthritis", [Chou, et a., August 2020] this study were to validate the outcome of total elbow arthroplasty (TEA) in patients with rheumatoid arthritis (RA), and to identify factors that affect the outcome. The primary aim was to determine the implant failure rate, the mode of failure, and risk factors predisposing to failure. A secondary aim was to identify the overall complication rate, associated risk factors, and clinical performance.
Another scientific literature titled "Revision total elbow arthroplasty with the ulnar component implanted into the radius for management of large ulna defects", [KD Bellevue, et al., April 2021] this study is to describe a surgical technique and report outcomes of patients who underwent revision TEA with implantation of the ulnar component into the radius to address ulna bony defects.
However, the solutions presented in the literatures have inherent merits and demerits. This widens the window for other possible solutions. Therefore, there exists a need to develop an advanced method that should overcome the shortcomings of the currently existing methods.
SUMMARY OF THE INVENTION
The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.
The objective of the present invention is to redesign Total Elbow Arthroplasty (TEA) implants to reduce the high incidence of complications such as aseptic loosening, periprosthetic fractures, and infections, which often necessitate revision surgeries.
The aforementioned aspects along with the objectives and the advantages can be achieved as described herein.
According to the embodiment of the present invention, implementing Digital Light Processing (DLP) technology to fabricate implants using materials like Pro-BLK 10; Rigid White and MED-AMB 10, which exhibit superior mechanical properties and environmental stability.
In an aspect of the present invention, we optimize printing parameters such as layer height and wall thickness in the DLP process to ensure high-quality and efficient fabrication of the new implant designs.
In an aspect of the present invention, we conduct rigorous testing using standardized specimens (e.g., ASTM D638 for tensile strength, ASTM D695 for compression, and ASTM G99 for wear) to evaluate the mechanical performance of the new materials and designs.
Further in accordance with the present invention, we ensure that the new implant designs demonstrate long-term durability and resistance to wear, thereby extending the lifespan of the prosthesis in patients.
BRIEF DESCRIPTION OF FIGURES
Other features and advantages of the present invention will become apparent from the detailed description of the invention which follows, when considered in light of the accompanying drawings in which:
Fig. 1 illustrates the methodology of the present invention;
Fig. 2 illustrates the design & manufacturing procedure of the present invention;
Fig. 3 illustrates the 3D assembly view of TEA;
DETAILED DESCRIPTION
The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.
The embodiments will be described in detail with corresponding marked references to the drawings, in which the illustrative components of the invention are outlined. The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are construed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.
It must also be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Although any systems and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the preferred, systems and methods are now described.
The objective of the present invention is to redesign Total Elbow Arthroplasty (TEA) implants to reduce the high incidence of complications such as aseptic loosening, periprosthetic fractures, and infections, which often necessitate revision surgeries.
Proccss flow diagram visually represents the sequence of steps involved in the design analysis and 3D printing process parameters for creating total elbow arthroplasty implants. Each stage is critical to ensuring that the final product is functional, safe, and tailored to the specific needs of the patient.
Current TEA designs, particularly semi-constrained linked prostheses, have been associated with a high incidence of complications, including aseptic loosening, periprosthetic fractures, and infections. These complications often lead to revision surgeries, indicating that existing designs may not adequately address the biomechanical challenges of the elbow joint. However, advancements in implant materials, such as those used in Digital Light Processing (DLP) technology, offer significant benefits for the fabrication of implants.
Materials like Pro-BLK 10, MED-AMB 10, and Rigid White exhibit excellent mechanical properties, including durability and long-term environmental stability, ensuring that the implants can withstand the stresses of the human body over time. In the DLP process, crucial printing parameters such as layer height and wall thickness are optimized for print quality and efficiency.
Testing specimens, including the ASTM D638 dog bone form for the Tensile Test, the ASTM D695 Compression Test, the ASTM G99 Wear Test, and the ISO 4287 CMM and Surface Roughness test specimen, are printed with these parameters, and the results are consolidated to find the suitable material for the new design of Total Elbow Arthroplasty.
Future Enhancements or Advancements
The field of total elbow arthroplasty (TEA) is continually evolving, driven by advancements in materials science, biomechanics, and medical imaging. The current invention of Digital Light Processing (DLP)-based TEA implants can benefit from several enhancements and advancements through further research.
 Future New Different Material Development
 New Coating on Material /Post Treatment / Surface Quality to Improve wear
 Testing the new TEA design under Serum Test
Application Areas:
Medical and Healthcare
Orthopedic Surgery:
 Specifically for total elbow arthroplasty (TEA) procedures, providing customized implants for patients.
Prosthetics and Implants:
 Creating highly accurate and durable prosthetic joints and other orthopedic implants using advanced 3D printing techniques.
Research and Development
Biomechanical Research:
 Studying the mechanical properties and performance of custom elbow implants.
Material Science:
 Developing and testing new biocompatible materials suitable for DLP-based printing and long-term implantation.
It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein," respectively. Moreover, the terms "first", "second," "third," and so forth, are used merely as labels, and are not intended to impose numerical requirements on their objects.
What has been described above includes examples of the disclosed architecture. It is, of course, not possible to describe every conceivable combination of components and/or methodologies, but one of ordinary skill in the art may recognize that many further combinations and permutations are possible. Accordingly, the novel architecture is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.
Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the illustrative examples, make and utilize the present invention and practice the claimed methods. It should be understood that the foregoing discussion and examples merely present a detailed description of certain preferred embodiments. It will be apparent to those of ordinary skill in the art that various modifications and equivalents can be made without departing from the spirit and scope of the invention.
, Claims:1. A design of total elbow arthroplasty (TEA) implant system to the patient's specific anatomical features, comprising:
a) A patient-specific design that allows precise tailoring to the individual's anatomy, ensuring optimal fit and natural joint movement;
b) An improved implant geometry that enhances biomechanics, replicating the natural kinematics of the elbow to reduce wear and enable more natural motion over time.
2. The total elbow arthroplasty (TEA) implant system of claim 1, wherein the implant is made from advanced biocompatible and durable materials that enhance the longevity of the implant and reduce the risk of adverse biological reactions.
3. The total elbow arthroplasty (TEA) implant system of claim 2, further characterized by specialized bioactive coatings that promote Osseo integration, facilitating bone in-growth and improving the stability and integration of the implant with surrounding bone tissue.
4. The total elbow arthroplasty (TEA) implant system of claim 1, wherein the implant's customized fit and function are enhanced by the use of advanced 3D printing technologies, including Digital Light Processing (DLP) techniques, to produce high-precision implants tailored to the patient's specific anatomical needs.
5. The total elbow arthroplasty (TEA) implant system of claim 4, wherein the DLP-based 3D printing technology allows for superior surface finishes and optimized mechanical properties specific to individual patients.
6. The total elbow arthroplasty (TEA) implant system of claim 1, wherein the improved implant geometry incorporates design features that reduce wear and enhance the implant's ability to withstand mechanical stress over time, improving implant longevity.
7. A method for manufacturing a patient-specific total elbow arthroplasty (TEA) implant, characterized by the steps of:
a) Scanning and analyzing the patient's specific anatomical features to create a customized implant design;
b) Fabricating the implant using Digital Light Processing (DLP)-based 3D printing to achieve high precision and superior surface finish;
c) Applying bioactive coatings to the implant to promote Osseo integration and enhance the stability of the implant.

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