Patient-Specific Medical Balloon Forming via Biometric 3D Modeling
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Solution Overview
Problem
Current coronary artery stenting techniques for bifurcation lesions are challenging due to the unique anatomy of each patient, leading to adverse blood flow and tissue stress, and existing balloon forming systems are costly and inefficient, requiring a one-size-fits-all approach that fails to accommodate individual vessel configurations.
Innovation Solution
A system and method for creating patient-specific medical balloons using biometric data and additive manufacturing to form balloons matched to individual blood vessel geometries, allowing for precise stent placement and improved blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If glass forms or copper alloy forms are used in current balloon forming systems, then the balloon can be formed, but the preparation is expensive and time consuming
Solution Approach 1:
The patent uses biometric data to create a digital 3D model of the patient's blood vessel, which is then used to generate a custom balloon design. This digital copying approach replaces the traditional physical glass or copper alloy forms, enabling rapid and cost-effective customization without manual form preparation.
Solution Approach 2:
The patent changes the material parameter from traditional glass or copper alloy forms to a biocompatible polymer material that can be rapidly fabricated using additive manufacturing. This parameter change enables faster preparation while maintaining the necessary form functionality for balloon formation.
2Adaptability or versatility
If glass and metal alloy form are used, then balloon forming is possible, but a one-size-fits-all approach is required as balloon dimensions are governed by the mold
Solution Approach 1:
The patent performs preliminary actions by acquiring biometric data and creating a 3D digital model of the patient's blood vessel before balloon fabrication. This preliminary customization process enables the subsequent balloon to be precisely matched to the patient's unique anatomy, eliminating the need for post-manufacturing adaptation.
Solution Approach 2:
The patent introduces dynamic adaptability by using additive manufacturing to create balloons with custom geometries that precisely match individual patient vasculature. This replaces the static one-size-fits-all mold approach with a dynamic, patient-specific design process that adapts to each unique anatomical configuration.
3Reliability
If standard stenting techniques are used for bifurcation lesions, then stent deployment is possible, but overlapping stents may promote restenosis or expose locations with no stent coverage
Solution Approach 1:
The patent applies local quality by customizing the balloon geometry to precisely match the patient's specific bifurcation lesion anatomy. This localized customization ensures that the stent is deployed with optimal positioning and coverage in the specific anatomical region, avoiding both overlaps and gaps that occur with standard techniques.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables the rapid and cost-effective creation of custom medical balloons that reduce the risk of restenosis and thrombosis, improving therapeutic outcomes by ensuring optimal stent placement and blood flow in bifurcation lesions.
Implementation Method 1
a heated jaw configured to surround the form and heat the parison within the form to a balloon forming temperature, wherein the heated jaw is thermally coupled to a heating element
Implementation Method 2
a conduit configured to provide a balloon forming medium for expanding the parison within the form; wherein the conduit is fluidly connected to a pressurizing system for pressurizing the balloon forming medium
Data Source
AI summary
Patient specific medical balloons, assemblies, and systems for forming the same, and devices and methods for treating patients in need of a percutaneous coronary intervention (PCI) are disclosed. The assembly for forming the medical balloon comprises a form for receiving a parison where the form is configured to prepare a patient specific medical balloon matched in geometry to a blood vessel or a lesion for a patient in need of a PCI.