Disposable Trial Stimulator with Wireless Programming
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Solution Overview
Problem
Current trial stimulation systems are reusable, which prevents sterilization between uses, leading to potential contamination and infection risks during surgical procedures, and are inconvenient for patient interaction due to integrated user input/output controls and external programming devices.
Innovation Solution
A disposable trial stimulator system that includes a sterilized stimulator, percutaneous stimulation leads, and an electronic programming device for wireless communication, with a lead coupler for direct connection to the stimulator and a patch-holster system for secure body attachment, allowing for improved durability and reduced risk of malfunction during the trial period.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable trial stimulators are used, then cost is reduced and device complexity is minimized, but sterilization between uses is prevented leading to contamination and infection risks
Solution Approach 1:
The patent implements a disposable trial stimulator that is used once and then discarded, eliminating the need for sterilization between uses. This single-use approach resolves the contradiction by making the device inherently disposable rather than reusable, thereby ensuring sterility without requiring complex sterilization protocols for reusable devices.
Solution Approach 2:
The system is designed to be discarded after a single use in the surgical procedure. The disposable stimulator is packaged in sterile condition, used once to deliver stimulation therapy during surgery, and then discarded, eliminating any risk of cross-contamination between different surgical procedures or patients.
2Ease of operation
If integrated user input/output controls are included in the trial stimulator, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The user input/output controls are extracted from the disposable trial stimulator and placed in a separate reusable programming device. This allows the disposable stimulator to remain simple while the programming device, which can be reused and sterilized, contains all the complex user interface elements for patient interaction and parameter adjustment.
Solution Approach 2:
A separate programming device serves as an intermediary between the user and the disposable stimulator. This mediator contains all the complex controls and interfaces, while communicating with the simple disposable stimulator to deliver therapy, thereby separating the complexity of user interaction from the simplicity of the single-use device.
3Device complexity
If external programming devices are used, then device complexity is reduced, but ease of operation deteriorates due to inconvenience for patient interaction
Solution Approach 1:
The programming device is designed to be worn on the patient's body, merging the external programming function with close patient proximity. This allows the patient to easily interact with the controls while the disposable stimulator remains simple, combining the benefits of separate device complexity management with convenient patient access to controls.
4Adaptability or versatility
If lead connection devices are used between the stimulator and leads, then adaptability is improved, but reliability deteriorates due to potential dislocation and malfunction
Solution Approach 1:
The lead connection interface is extracted and integrated directly into the disposable trial stimulator housing. This eliminates separate connection devices that could become dislodged, while the integrated connection maintains adaptability to different lead types through direct coupling mechanisms built into the stimulator itself.
Solution Approach 2:
The disposable nature of the stimulator allows for integrated, non-removable lead connections that prioritize reliability over reusability. Since the entire device is discarded after one use, the connection system can be optimized for maximum stability without concern for long-term durability or repeated connections.
Data Source
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AI summary
A trial stimulation system includes a disposable trial electrical stimulator that, in some examples, is sterilized for a single use in a stimulation trial of one patient. Additionally, systems for securing a disposable trial stimulator to the body of a patient are described, which may function to improve the durability of the system during the trial period and reduce the risk of damage or malfunction to the system due to lead/electrode dislocation and/or off-label uses like showering or bathing with the trial stimulator still secured to the body.