Adjustable Sling for Anal Incontinence and Pelvic Organ Prolapse
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Solution Overview
Problem
Current treatments for anal incontinence and pelvic organ prolapse are often invasive, have low success rates, and lack effective solutions for associated defecatory dysfunctions such as constipation and incomplete bowel emptying, with few minimally-invasive options available.
Innovation Solution
The development of systems and methods involving synthetic or natural slings placed under the rectum with adjustable fluid-filled sacs or mesh materials to restore the ano-rectal angle, supported by sutures and anchors, facilitating minimally-invasive treatment of anal incontinence and pelvic organ prolapse by providing structural support and adjustable tension.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical correction is used to treat anal incontinence, then specific defects in the anal sphincters can be addressed, but the success rate is only 50% or less on long-term follow-up
Solution Approach 1:
The treatment approach is segmented into multiple components: the sling system for structural support, the fluid-filled sac for dynamic adjustment, and the anchoring mechanism for stabilization. This segmentation allows each component to be optimized independently and facilitates minimally invasive implantation through separate incisions.
Solution Approach 2:
The fluid-filled sac provides dynamic adjustability to the sling system, allowing the tension and support level to be modified after implantation. This dynamic feature enables optimization of the treatment effect without requiring additional surgery, thereby improving long-term success rates.
2Reliability
If artificial anal sphincter is used to bypass damaged muscles, then continence can be restored, but the surgery involves extensive dissection and requires patient to depress a subcutaneous valve
Solution Approach 1:
The invention extracts the essential function of sphincter support from the complex artificial sphincter mechanism. By using a simple sling system with fluid-filled sac, it provides continence restoration without requiring the extensive dissection and valve mechanism of traditional artificial sphincters.
Solution Approach 2:
The sling system uses flexible material that can be implanted through minimally invasive techniques. The fluid-filled sac provides a flexible, adjustable component that conforms to the anatomical structures, eliminating the need for extensive dissection required by rigid artificial sphincter devices.
3Reliability
If dynamic graciloplasty is performed to wrap the gracilis muscle around the anorectum, then continence can be improved, but the procedure is complex and requires extensive experience
Solution Approach 1:
The sling system acts as an intermediary structure that provides the necessary support function without requiring complex muscle manipulation. The fluid-filled sac serves as a mediator that allows adjustment of the support level, simplifying the procedure while maintaining effectiveness.
4Reliability
If sacral nerve stimulation is used to treat fecal incontinence, then some success can be achieved, but the mechanism remains unclear and it may not be appropriate for patients with anatomic abnormalities
Solution Approach 1:
The sling system with fluid-filled sac provides a universal solution that addresses the mechanical support deficiency in various conditions including anal incontinence, rectal prolapse, and pelvic organ prolapse. This multi-functional approach makes it applicable to patients with different anatomic abnormalities who may not be suitable for nerve stimulation.
5Reliability
If retrorectal levatorplasty is performed to treat posterior rectocele, then levator muscles can be plicated, but the procedure requires extensive dissection and has limited treatment options
Solution Approach 1:
The sling system provides support from a different dimensional approach - placing the sling in the retrorectal space and anchoring it to the coccyx creates support in the anterior-posterior dimension, effectively treating posterior rectocele without requiring extensive lateral dissection of the levator muscles.
Data Source
AI summary
Using a sling that includes a central portion and at least two arms extending from the central portion, a method of treating anal incontinence may include positioning the central portion posteriorly to the rectum and/or anus of a subject, and extending each arm of the sling to a respective obturator region. Using a sling having the same or similar structure, a method of treating pelvic organ prolapse may include positioning the central portion beneath the ano-rectum of a subject, and extending each arm of the sling to a respective thigh incision near the obturator region.