Urethral Sphincter Stimulation for Urine Flow Control
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Solution Overview
Problem
Existing urinary incontinence treatments, such as artificial sphincters, often lead to tissue injury and fibrosis due to inadequate blood circulation, and electric stimulation is ineffective for completely non-functional sphincters or those with severe tissue damage.
Innovation Solution
A method involving gentle constriction of the urethral tissue wall combined with intermittent stimulation to control urine flow, ensuring blood circulation and preventing tissue damage, using a combination of constriction and stimulation devices that can be calibrated and controlled to restrict or allow urine flow as needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an artificial hydraulic sphincter device is implanted to control urine flow, then urinary incontinence is treated, but hard fibrosis develops around the reservoir causing malfunction and tissue injury occurs due to inadequate blood circulation
Solution Approach 1:
The patent replaces the mechanical hydraulic sphincter system with an electrical stimulation system. Instead of using a manually operated hydraulic device with reservoir and pumping components, the invention uses electrodes to deliver electrical pulses to the urethral sphincter muscle, stimulating it to contract and close the urethra. This eliminates the mechanical components that cause fibrosis and tissue injury while maintaining urine flow control functionality.
Solution Approach 2:
The electrical stimulation system activates the patient's own urethral sphincter muscle to perform the closing function. Rather than implanting an external mechanical device that interacts with and damages surrounding tissue, the invention uses electrical signals to make the body's own muscle do the work, eliminating the harmful interaction between implanted hardware and surrounding tissues.
2Ease of operation
If manual squeezing of the elastic implanted reservoir is used to pump hydraulic fluid, then the sphincter device can be opened for urination, but the operation becomes complicated and fingers may get wet
Solution Approach 1:
The manual mechanical pumping operation is replaced with an electrical stimulation system controlled by a simple button press. The patient presses a button on an external controller, which sends electrical pulses through the body to stimulate the sphincter muscle to relax and open the urethra. This eliminates the complex manual squeezing of reservoirs and the risk of urine contact with fingers.
Solution Approach 2:
An external wireless controller serves as an intermediary between the patient's intent and the implanted stimulation electrodes. The patient presses a button on the external device, which communicates wirelessly with the implanted pulse generator, which then delivers the appropriate electrical stimulation pattern to open the sphincter. This multi-step intermediary system simplifies the patient's interaction while maintaining precise control.
3Reliability
If electric stimulation is applied to the urethral sphincter, then muscle contraction can be stimulated, but it is ineffective for completely non-functional sphincters or those with severe tissue damage
Solution Approach 1:
The system uses programmable electrical stimulation parameters including pulse width, frequency, amplitude, and train duration that can be adjusted based on the severity of the condition. For partially functional sphincters, lower intensity and shorter duration pulses are used. For severely damaged or non-functional sphincters, the system can deliver higher intensity pulses or use different stimulation patterns to achieve muscle contraction or prevent atrophy, making it adaptable across the full range of severity.
Solution Approach 2:
The stimulation system is fully programmable and adaptable, allowing the stimulation parameters to be dynamically adjusted based on the patient's specific condition and response. The system can be reprogrammed over time as the muscle responds to treatment, with parameters modified to optimize effectiveness for each individual case, from mild to severe dysfunction.
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
This approach effectively manages urine flow while minimizing tissue injury and maintaining blood circulation, providing a more reliable and safer solution for urinary incontinence compared to previous methods.
Implementation Method 1
stimulating the constricted wall portion to cause contraction of the wall portion
Data Source
AI summary
There is provided a method for controlling a flow of urine in the urinary passageway of a patient's urethra, ureter, renal pelvis or bladder. The method comprises gently constricting (i.e., without substantially hampering the blood circulation in the urinary tissue wall) at least one portion of the urinary tissue wall to influence the flow in the urinary passageway, and stimulating the constricted wall portion to cause contraction of the wall portion to further influence the flow in the urinary passageway. The method can be used for restricting or stopping the flow in the urinary passageway of a urinary incontinent patient, or for actively moving the urine in the urinary passageway, with a low risk of injuring the urethra, ureter, renal pelvis or bladder.