Patient-Specific Interbody Implants for Precise Vertebral Fit

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Solution Overview

Problem

Traditional orthopedic implants, particularly interbody implants used in spinal fusion surgeries, often fail to provide an optimal fit due to insufficient contact and load transfer between the implant and vertebrae, leading to inadequate fixation, micro- and macro-motions, and increased risk of implant expulsion or subsidence, which can result in suboptimal bone growth and fusion, and require extensive logistical and financial efforts for shipping and sterilization of various stock sizes.

Innovation Solution

Patient-specific interbody implants are designed using preoperative imaging and surgical planning software to accurately determine the negative space between vertebrae, allowing for optimal sizing and shaping that reduces the need for intraoperative trialing and minimizes radiation exposure, with internal features engineered for osteo-integration and structural stiffness tailored to individual anatomical demands.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If stock implants with standard sizes and shapes are used, then logistical and financial efforts for shipping and sterilization are reduced, but the implant fit and contact with vertebrae are insufficient

Engineering Contradiction:
Improvelogistical and financial effortsVSAvoidimplant fit
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The implant design and sizing are performed in advance through preoperative imaging and virtual surgical planning. The negative space between vertebrae is determined before surgery, allowing the implant to be precisely tailored to the patient's anatomy without requiring extensive intraoperative trialing of multiple stock sizes.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The implant is customized to match the specific local anatomical requirements of each patient's vertebral space. The implant's shape, size, and internal features are tailored to the unique geometry of the negative space, ensuring optimal contact and load transfer at the implant-vertebrae interface.

Inventive Principle:
Principle #3Local quality

2Reliability

If intraoperative trialing of multiple implant sizes is performed, then optimal implant selection is achieved, but radiation exposure increases

Engineering Contradiction:
Improveoptimal implant selectionVSAvoidradiation exposure
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The optimal implant size and configuration are determined before surgery through preoperative imaging and virtual surgical planning. The negative space is mapped and the implant is designed in advance, eliminating the need for intraoperative trialing with multiple implant sizes and thereby reducing radiation exposure from repeated imaging.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A virtual model or copy of the patient's anatomy is created from preoperative imaging data. The implant is designed and tested in this virtual environment, allowing optimal implant selection without requiring physical trial implants and associated radiation exposure from intraoperative imaging.

Inventive Principle:
Principle #26Copying

3Device complexity

If stock implants are used, then device complexity and inventory management are simplified, but fixation strength and load transfer are insufficient

Engineering Contradiction:
Improveinventory managementVSAvoidfixation strength
Core Design Contradiction:
Device complexityVSStrength

Solution Approach 1:

The implant's internal features and structural properties are customized to match the specific load requirements and anatomical geometry of each patient. This includes tailoring the implant's stiffness, porosity, and internal architecture to optimize both fixation strength and bone ingrowth potential for that specific application.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The implant's physical and mechanical parameters are varied to match patient-specific requirements. This includes adjusting size, shape, material composition, porosity, and internal features to optimize the implant's performance in terms of fixation strength, load transfer, and osteointegration for each individual case.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11696833B2Systems and methods for orthopedic implants
Publication Date: 2023.07.11 CARLSMED INC
  • US11696833B2 patent drawing
  • US11696833B2 patent drawing
  • US11696833B2 patent drawing

AI summary

A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.