Patient Interface Module Preventing Intravascular Device Reuse
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Solution Overview
Problem
Unauthorized reuse of disposable intravascular devices poses safety risks to patients and financial losses for manufacturers, as these devices are not verified or validated for subsequent use.
Innovation Solution
A patient interface module (PIM) is used to communicate with intraluminal devices, enabling selective transmission of read and write commands to the device's memory, utilizing a voltage switch with MOSFETs to prevent further operation by writing a date stamp or erasing data, thereby disabling the device after initial use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravascular devices are made disposable and rated for single use only, then patient safety and data integrity are improved, but device cost and waste increase due to discarding after one use
Solution Approach 1:
The patent changes the functional state of the device through voltage-dependent memory operations. The memory device transitions from a readable state during initial use to a locked or erased state after use, preventing reuse. This parameter change in memory accessibility effectively disables the device after single use, maintaining safety while enabling controlled disposal.
Solution Approach 2:
The patent implements true disposable functionality by ensuring the device cannot be reused through voltage-controlled memory locking or erasure. The intraluminal device is designed to be discarded after one use, with the memory prevention mechanism ensuring that even if physically recovered, the device cannot be reactivated or data extracted, making it a genuine single-use product.
2Productivity
If third parties collect and reuse intravascular devices after sterilization, then device cost decreases for users, but patient safety deteriorates due to lack of verification and validation
Solution Approach 1:
The patent applies preliminary anti-action by preemptively disabling the device memory through voltage-controlled locking or erasure operations immediately after use. This prevents any future access to the device or its data, countering potential unauthorized reuse or data extraction by third parties before such attempts can occur.
Solution Approach 2:
The patient interface module acts as an intermediary that controls voltage signals to the memory device. It mediates between the intraluminal device and external systems, allowing legitimate read operations during authorized use while blocking unauthorized write or read operations that would enable reuse or data extraction by third parties.
3Reliability
If a voltage switch with MOSFETs is used to control read and write commands to memory, then device security against unauthorized reuse is improved, but device complexity increases
Solution Approach 1:
The memory device performs self-protection through voltage-dependent operation. The same memory structure that stores data also responds to voltage levels to control its own accessibility. High voltage signals trigger locking or erasure states, making the memory self-protecting without requiring external hardware security modules or complex encryption circuits.
Solution Approach 2:
The patent replaces complex mechanical or hardware security mechanisms with electrical voltage control. Instead of using physical locks, biometric authentication, or complex cryptographic hardware, the system uses simple voltage-level control through MOSFETs to achieve memory protection, substituting electrical control for mechanical security systems.
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
Prevents unauthorized reuse of intravascular devices, ensuring patient safety and reducing financial losses by ensuring devices are used only once, as intended by the manufacturer.
Implementation Method 1
The PIM selectively outputs the first voltage or the second voltage using a voltage switch including a plurality of electronic components, such as transistors
Data Source
AI summary
A sensing system includes a patient interface module (PIM) communicatively disposed between a processing system and a sensing device configured to obtain measurement data associated with a body of a patient while positioned within the body, the sensing device comprising a memory, wherein the patient interface module comprises: a controller operable to: read data stored on the memory of the sensing device using a first signal voltage; and write to the memory to disable further operation of the sensing device using a second signal voltage; and a voltage switch configured to selectively output the first signal voltage or the second signal voltage.