Cylindrical Acoustic Pulse Generator for Urethral Energy Uniformity
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Solution Overview
Problem
Current low energy acoustic pulse (LEAP) therapy devices lack the ability to deliver uniform acoustic pulse energy along the length of the female urethra, leading to inadequate treatment of urinary incontinence due to focal zones and high energy flux densities that can cause pain and tissue damage.
Innovation Solution
A LEAP apparatus that generates an acoustic energy pulse with a cylindrically shaped energy density field, ensuring a minimum energy density of at least 50% of the maximum at all points within a 2 cm or longer cylindrical space, allowing for effective treatment of the urethra without repositioning, with a maximum energy density ranging from 0.005 to 0.11 mJ/mm2 and a diameter of 10 to 18 mm.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Power
If a focused shockwave device is used to treat the urethra, then high energy flux density is achieved at the focal zone, but uniform energy delivery along the entire urethra is compromised and multiple repositioning applications are required
Solution Approach 1:
The treatment process is segmented into multiple discrete acoustic pulse applications along the urethral length. The device delivers pulses at different positions (proximal, mid, distal segments) to ensure complete coverage of the entire urethra, with each segment receiving adequate energy treatment
Solution Approach 2:
The invention transitions from a single focal zone in one dimension to a distributed array of pulse delivery points along the longitudinal dimension of the urethra. This dimensional expansion allows uniform energy delivery throughout the entire urethral length without requiring mechanical repositioning of the device
2Power
If extracorporeal shockwaves are applied through the vaginal canal to treat urinary incontinence, then the urethra can be targeted, but the vaginal canal is exposed to high energy shockwaves causing pain and potential tissue damage
Solution Approach 1:
The invention changes the energy parameter from high-intensity shockwaves (capable of tissue disruption) to low-energy acoustic pulses (therapeutic range). This parameter modification delivers sufficient energy for therapeutic effect while remaining below the threshold for pain and tissue damage in surrounding structures
Solution Approach 2:
The acoustic pulses are localized to the urethral tissue with energy deposition concentrated at the target site. The low-energy pulses provide localized therapeutic effect to the urethra while minimizing energy exposure and potential harm to adjacent vaginal and pelvic tissues
3Ease of manufacture
If a fixed-size probe is used for shockwave treatment, then device construction is simplified, but patients with smaller vaginal canals cannot be treated
Solution Approach 1:
The device incorporates adjustable and reconfigurable probe components that can be dynamically adapted to different patient anatomies. The probe length, diameter, and pulse delivery array configuration can be modified to accommodate varying vaginal canal sizes while maintaining standardized manufacturing processes for the base device
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 apparatus provides a therapeutic result by uniformly delivering energy along the urethra, effectively treating urinary incontinence with reduced pain and tissue damage, as evidenced by significant improvements in urine leakage reduction in clinical trials.
Implementation Method 1
an acoustic energy pulse generator producing an acoustic energy pulse having an energy density field
Data Source
AI summary
An apparatus for generating an acoustic energy pulse and delivering it into a body is described. The apparatus includes a generator for creating an acoustic energy pulse having an energy density field that can be measured at all points within a space in the shape of an imaginary cylinder having a length greater than or equal to 2 cm and a diameter. The cylindrically shaped space has a cylinder longitudinal axis oriented relative to a longitudinal axis of the energy pulse at an angle in the range from zero to twenty degrees. A minimum energy density for the pulse at all locations within the cylindrically shaped space is at least 50% of a maximum energy density for the pulse within the space.