Intraluminal Imaging Catheter Usage Tracking for Secure Reuse
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Solution Overview
Problem
Existing intraluminal imaging catheters, such as ICE catheters, face issues with performance degradation due to multiple uses without proper tracking and reprocessing, posing risks to patient safety and clinical decision-making.
Innovation Solution
A disposable intraluminal catheter equipped with a non-volatile memory that tracks usage through a system involving manufacturer, clinical, and reprocessor workstations, ensuring secure and authorized reuse by encrypting and checksumming memory regions to prevent unauthorized reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If disposable intraluminal catheters are reused without tracking, then cost is reduced, but reliability and patient safety deteriorate due to performance degradation and unauthorized reuse
Solution Approach 1:
The catheter contains an embedded memory device that automatically tracks its own usage history, sterilization cycles, and operational parameters. This self-recording capability eliminates the need for external tracking systems while ensuring reliable data capture for determining catheter reuse eligibility.
Solution Approach 2:
The system provides feedback by storing usage data in the catheter's memory and enabling workstations to read and analyze this data before allowing reuse. This feedback mechanism ensures that only catheters meeting predetermined reuse criteria are authorized for subsequent use, maintaining reliability while enabling controlled reuse.
2Reliability
If catheter usage is tracked with detailed memory storage, then reliability and safety are improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The catheter is designed as a disposable device with an integrated memory component that can be easily manufactured at low cost. The memory device stores comprehensive usage data, and the entire catheter is discarded after a single use, eliminating the need for complex retrieval and resetting mechanisms while ensuring tracking accuracy.
Solution Approach 2:
Instead of modifying existing reusable catheters with complex tracking systems, the invention creates a new disposable catheter design that incorporates memory functionality from the outset. This approach simplifies manufacturing by integrating the memory device during initial catheter production rather than adding it as a separate modification.
3Object-affected harmful factors
If memory regions are encrypted and access is restricted, then security against unauthorized reuse is improved, but ease of operation and reprocessing complexity increase
Solution Approach 1:
The memory device is divided into multiple regions with different access permissions: a first region that can be read by any workstation and a second region that requires encryption keys for access. This segmentation allows straightforward reading of basic catheter information while protecting sensitive usage data that determines reuse eligibility, balancing security with operational ease.
Solution Approach 2:
The encrypted memory region acts as an intermediary that controls access to reuse authorization data. The encryption mechanism mediates between the need for secure data protection and the need for simple reprocessing workflows, allowing authorized workstations to easily access permitted information while blocking unauthorized access to critical reuse decisions.
4Measurement precision
If comprehensive usage data is stored in the catheter, then measurement precision and tracking accuracy are improved, but loss of time for data processing and verification increases
Solution Approach 1:
The catheter's memory device continuously records usage data, sterilization information, and operational parameters during the catheter's lifecycle. This preliminary data collection occurs automatically without requiring real-time processing or verification, allowing comprehensive accurate data to be ready for quick review when the catheter is presented for potential reuse.
Solution Approach 2:
The memory device extracts and stores only the critical usage parameters needed for reuse determination in a structured format. By selectively capturing essential data points rather than storing all possible information, the system maintains high measurement precision for relevant parameters while minimizing the time required for data verification during reprocessing.
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
Ensures secure, trackable, and verifiable reuse of medical sensors, preventing unauthorized reuse and ensuring proper reprocessing, thereby maintaining catheter performance and patient safety.
Implementation Method 1
a non-volatile memory, a manufacturer's console or manufacturer's workstation capable of writing encrypted or unencrypted data to three different regions of the non-volatile memory
Implementation Method 2
a clinical console or clinical workstation capable of writing encrypted data to two of the three regions of the non-volatile memory, and a reprocessor's console or reprocessor's workstation capable of writing encrypted data to one of the three regions of the non-volatile memory
Data Source
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AI summary
An intraluminal imaging catheter includes: a flexible elongate member configured to be positioned within a body lumen of a patient; an ultrasound transducer array coupled to the flexible elongate member and configured to obtain imaging data while positioned within the body lumen; and a memory comprising a plurality of regions configured to store one or more values for one or more fields, wherein the plurality of regions comprises a first region, wherein the one or more fields in the first region comprises at a device identification, a serial number, and/or a manufacturing date, wherein the plurality of regions comprises at least a second region, wherein the one or more fields in the at least the second region comprises a current use count, a maximum number of uses, and a status of the intraluminal imaging catheter. Associated devices, systems, and methods are also disclosed.