Custom hip design and insertability analysis
Inventors
Assignees
Icahn School of Medicine at Mount Sinai
Publication Number
US-12303393-B2
Publication Date
2025-05-20
Expiration Date
2040-04-16
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Abstract
Computer implemented methods, systems, and computer products employing program code or algorithms for use in customized patient specific hip implants or femoral stems or sleeves having an outer surface that corresponds more closely to the inner surface of the cortical bone of a patient's femur compared to conventional hip implant or femoral stems or sleeves based on population-based design.
Core Innovation
The invention provides computer implemented methods, systems, and computer products employing program code or algorithms to create customized patient specific hip implants, such as femoral stems or sleeves. These customized implants have an outer surface that more closely corresponds to the inner surface of the cortical bone of a patient's femur compared to conventional population-based designs. The customization is based on three-dimensional data representing the patient's proximal femur, which includes centralized cancellous bone and peripheral cortical bone.
Currently, hip implants are designed through statistical analysis of large datasets to create generic geometric implants optimized for population fit. This process is labor-intensive, time-sensitive, and subjective in population selection and acceptable fit criteria. Conventional femoral stems are tapered, thin, and symmetrical, compensating for low bone contact by increasing stem length. However, insertability analysis of these generic implants is not typically performed per patient, and surgeons manually prepare the femur cavity to fit standardized implants.
The invention solves these issues by generating an initial implant matching the inner surface of the peripheral cortical bone and then modifying this implant along a generated insertion/removal path through the cancellous bone. This modified implant allows insertion and removal adjacent to the cortical bone without obstruction, preserving bone and maximizing cortical contact for stability. The methods include identifying proximal and distal extremes, generating insertion paths via axes representing femoral neck and shaft, constructing initial implants, simulating insertability, and iteratively modifying implant geometry to ensure fit along the insertion/removal path without excessive interference.
Claims Coverage
The patent includes multiple independent claims directed to computer implemented methods, systems, and computer program products for forming patient specific femoral stems or sleeves for total hip replacement. The inventive features involve generating and modifying 3D implant data based on patient femur imaging and insertion/removal path analysis.
Generation of patient specific initial implant data
Obtaining three-dimensional data representing a patient's proximal femur and generating three-dimensional data of an initial implant having an outer surface corresponding to the inner surface of the patient's peripheral cortical bone.
Insertion/removal path generation and utilization
Generating data representing an insertion/removal path through the centralized cancellous bone based on three-dimensional data of the proximal femur, including generating multiple possible insertion paths and selecting optimized paths.
Modification of initial implant based on insertion/removal path
Translating the initial implant along the insertion/removal path without rotation and modifying the implant shape to remove interferences along the path to ensure insertability and fit adjacent to cortical bone.
Use of incremental translations and selection for optimized implant geometry
Translating the initial implant by a plurality or series of incremental translations and selecting the translation requiring least modification for the patient specific implant.
Integration of anatomical axes
Employing femoral neck axis and femoral shaft axis data to constrain the insertion/removal path and ensure implant geometry aligns coaxially at proximal and distal ends.
Fabrication of patient specific implant
Fabricating the patient specific femoral stem or sleeve based on the generated three-dimensional implant data through methods such as 3D printing, additive manufacturing, forging, or casting.
The claims cover methods and systems for generating customized femoral implants by obtaining patient-specific 3D data, generating initial implant geometry, creating insertion/removal paths informed by anatomical axes, iteratively translating and modifying implant designs to ensure insertability and cortical bone contact, and fabricating the customized implants based on these data-driven designs.
Stated Advantages
Enables maximizing implant stability by increasing cortical bone contact through patient-specific implant geometry.
Facilitates insertability through pre-operative simulation and iterative modification of implant shapes along a defined insertion/removal path.
Reduces design time and costs compared to traditional population-based implant design by automating geometric shaping and insertability analysis.
Allows for bone-preserving implant designs by minimizing implant size while maintaining stability.
Supports integration with surgical robots and intra-operative visualization for optimized insertion trajectories.
Documented Applications
Design and manufacture of customized patient specific femoral stems or femoral sleeves for total hip replacement surgeries.
Pre-operative simulation and insertability analysis of hip implant components using patient-specific anatomical data.
Use in orthopedic surgical procedures including total hip arthroplasty to improve fit and stability of implants.
Production of implants via methods such as three-dimensional printing, additive manufacturing, forging, or casting based on custom generated data.
Potential extension to design of patient-specific implants for knee, shoulder, and acetabular components in orthopedic surgeries.
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