Adjustable Urethral Sling Tensioning System
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Solution Overview
Problem
Current surgical methods for treating female urinary incontinence face challenges in achieving appropriate tensioning of suburethral support slings post-operatively, leading to complications such as persistent incontinence and voiding dysfunction due to under- or over-tensioning.
Innovation Solution
A supplementary stabilization system comprising absorbable, flexible elongate thread members with stabilizers and a tensioner mechanism that allows for immediate and short-term adjustment of urethral support sling tension post-operatively, enabling fine-tuning of tension for up to a week after implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a suburethral support sling is implanted to treat urinary incontinence, then urinary incontinence is alleviated by occluding the mid-urethra, but inappropriate tensioning (under- or over-tensioning) causes persistent incontinence and voiding dysfunction
Solution Approach 1:
The sling system incorporates adjustable tensioning mechanisms that allow the sling to transition from a static implant to a dynamically adjustable support. The system enables post-operative modification of sling tension through mechanisms such as adjustable anchors, sliding components, or magnetic adjustment systems, allowing clinicians to optimize the balance between occlusion effectiveness and voiding function based on patient response.
Solution Approach 2:
The invention allows changing the tension parameter of the sling after implantation. Through adjustable anchoring systems, the position and tension of the sling can be modified to achieve optimal occlusion of the mid-urethra without causing excessive outlet resistance. This parameter adjustment capability enables fine-tuning of the therapeutic effect while minimizing complications.
2Reliability
If the sling tension is increased to improve occlusion of the mid-urethra, then urinary incontinence is reduced, but voiding dysfunction and post-operative urinary retention increase
Solution Approach 1:
The adjustable tensioning system allows the occlusion force to be dynamically optimized. The sling can be initially implanted with moderate tension and then adjusted post-operatively to achieve the precise level of occlusion needed for incontinence control without exceeding the threshold that causes voiding dysfunction. This dynamic adjustment capability enables separation of the occlusion function from harmful outlet resistance.
Solution Approach 2:
The system incorporates feedback mechanisms that allow clinicians to assess patient response to sling tension and adjust accordingly. Through follow-up evaluations of incontinence control and voiding function, the sling tension can be modified to achieve optimal therapeutic effect while avoiding complications. This feedback-driven adjustment process enables fine-tuning of the balance between occlusion and voiding.
3Ease of operation
If the sling tension is decreased to reduce voiding dysfunction, then urinary incontinence control is improved, but persistent incontinence increases
Solution Approach 1:
The adjustable sling system enables post-operative increase of tension to enhance occlusion effectiveness. If initial tension is insufficient for incontinence control, the system allows for subsequent tightening to achieve adequate mid-urethral occlusion without causing voiding dysfunction. This dynamic adjustment capability enables optimization of incontinence control while maintaining safe tension levels.
4Measurement precision
If immediate post-operative assessment of sling tension is performed, then appropriate tensioning can be achieved, but the assessment is difficult and frequently found to be excessive or insufficient once the patient has assumed normal posture and movement
Solution Approach 1:
The adjustable tensioning system allows for sequential assessment and adjustment of sling tension under different patient conditions. The sling can be initially assessed in the operating room, then re-assessed and adjusted after the patient assumes normal posture and begins movement. This dynamic adjustment capability enables the tension to be optimized for real-world functional conditions rather than just the surgical position.
Solution Approach 2:
The system allows preliminary implantation of the sling with estimated appropriate tension, followed by subsequent adjustment based on actual patient response and functional assessment. This two-stage approach enables initial placement followed by fine-tuning once the patient is mobile and experiencing normal physiological conditions, thereby improving the accuracy of tension assessment in functional positions.
Data Source
Figure 1~2B
Figure 2A
Figure 3A~3B
AI summary
A urethral support stabilization system for stabilizing a suburethral sling for the treatment of urinary incontinence in a patient comprising a first elongate thread member and a second elongate thread member, each thread member comprising a flexible material comprising a length extending from a first end to a second end, a first stabilizer and a second stabilizer, said first stabilizer joined to said first end of said first thread member; said second stabilizer joined to said first end of said second thread member; and a support member comprising a length shorter than each of said first thread member and second thread member, a first end and a second end, the first end of said support member joined to said first stabilizer, the second end of said support member joined to said second stabilizer. The elongate thread members enable temporary adjustment for a few days after the sling is placed in a patient..