Prostatic Urethra Implant Delivery With Controlled Deployment
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Solution Overview
Problem
Traditional surgical treatments for benign prostatic hyperplasia (BPH) are invasive, irreversible, and carry risks such as infection, sexual dysfunction, and urinary incontinence, while less invasive therapies lack reversibility and may require prolonged recovery periods.
Innovation Solution
A system for delivering and deploying an implant in the prostatic urethra using an elongated sheath and pusher mechanism, allowing controlled deployment and repositioning through a cystoscope, with features for irrigation and implant engaging elements to ensure accurate placement and minimize tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical procedures are used to treat BPH, then significant prostate tissue can be removed to relieve symptoms, but the treatment becomes irreversible and carries significant risks including infection, sexual dysfunction, and urinary incontinence
Solution Approach 1:
The patent replaces traditional mechanical surgical removal methods with a balloon expansion mechanism. The treatment uses inflatable balloons that are inserted through the urethra and expanded to compress prostate tissue against the urethral wall, thereby relieving obstruction without requiring tissue removal. This substitution of mechanical action eliminates the harmful effects of surgery while maintaining symptom relief.
Solution Approach 2:
The patent changes the physical state of the treatment from permanent tissue removal to temporary mechanical compression. By using inflatable balloons that can be inflated and deflated, the treatment becomes reversible and non-permanent. The balloon expansion temporarily compresses tissue to open the urethral lumen, and the ability to deflate the balloon provides a reversible mechanism that avoids irreversible surgical changes.
2Reliability
If traditional surgical procedures are used to treat BPH, then prostate tissue can be removed to enlarge the urethra, but recovery periods can last 3 to 6 weeks
Solution Approach 1:
The patent replaces the mechanical trauma of surgical resection with a non-invasive balloon expansion mechanism. The balloons are inflated through the urethra to compress tissue and open the lumen without cutting or removing any tissue. This eliminates the need for surgical healing and significantly reduces recovery time from weeks to minutes.
Solution Approach 2:
The patent skips the lengthy surgical recovery process by using a minimally invasive approach. The balloon expansion procedure can be completed in minutes without requiring hospitalization, anesthesia, or surgical incisions. The treatment rushes through the therapeutic action quickly, avoiding the prolonged recovery period associated with traditional surgery.
3Object-affected harmful factors
If less invasive therapies are used to avoid tissue destruction, then trauma is reduced, but the treatments are irreversible and may require prolonged recovery
Solution Approach 1:
The patent uses parameter changes in the physical state of the treatment device to achieve reversibility. The inflatable balloons can be inflated to compress tissue and then deflated to release the compression. This state change mechanism makes the treatment fully reversible, allowing the urethra to return to its original state after the procedure, thereby eliminating the irreversibility problem of less invasive therapies.
Solution Approach 2:
The patent introduces dynamic elements to the treatment through the use of inflatable balloons that can change volume. The balloons transition from a deflated state to an inflated state during treatment, and can be deflated afterward. This dynamic capability provides reversibility and control, allowing the treatment to be adjusted or undone if necessary, unlike static less invasive therapies.
4Object-affected harmful factors
If prostatic implants are used to enlarge the urethra without tissue removal, then tissue destruction is avoided, but the implants cannot be easily repositioned if misdeployed
Solution Approach 1:
The patent uses dynamic inflatable balloons that can be inflated and deflated, providing a reversible treatment mechanism. If the balloons are misdeployed or cause unwanted effects, they can be deflated and removed through the urethra, allowing for easy repositioning or retreatment. This dynamic characteristic eliminates the permanent implant problem and enables simple correction of deployment errors.
Solution Approach 2:
The patent extracts the treatment mechanism from the body through the urethral opening, allowing for easy insertion and removal. The inflatable balloons are introduced through the urethra, inflated to the treatment site, and can be deflated and extracted through the same opening. This extraction capability provides ease of repair and repositioning, unlike permanent implants that are difficult to remove or reposition.
Data Source
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AI summary
Devices and systems are disclosed for managing and/or treating body tissues obstructing a hollow body lumen, including the prostatic lobe tissues obstructing the urethra, for example conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO) and associated lower urinary tract symptoms (LUTS). An implant is maintained in a constrained configuration within a distal portion of an elongated sheath so that is may be deployed by driving the implant with a pusher coaxially disposed within the sheath. An implant engaging element helps maintain control of the implant during deployment.