Pre-formed Loop Suture for Minimally Invasive Pelvic Implant
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Solution Overview
Problem
Current medical procedures for treating pelvic dysfunctions such as uterine prolapse, cystoceles, and rectoceles often require invasive methods like hysterectomy and involve challenging implantation techniques with flexible implants that can be difficult to orient and secure, leading to improper placement and damage.
Innovation Solution
The development of an apparatus and method using a suture with a pre-formed loop and a trocar needle to secure an implant to pelvic tissue, with a delivery device that helps guide the implantation and prevent entanglement or damage, allowing for minimally invasive uterine preservation and support without the need for hysterectomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If flexible implants are used for pelvic floor repair, then the implant can adapt to body contours and reduce trauma, but the implant becomes difficult to orient and manage during implantation
Solution Approach 1:
The implant is pre-formed into a specific configuration (such as a U-shape or arch shape) that corresponds to the target anatomical location. This preliminary shaping allows the implant to be easily oriented during implantation by simply aligning the pre-formed shape with the body contours, eliminating the need for complex manual manipulation of flexible material during the procedure.
Solution Approach 2:
A delivery device or guide catheter is used as an intermediary tool to manage the flexible implant during implantation. The delivery device provides structural support to the flexible implant, enabling precise orientation and placement without requiring direct manual manipulation of the flexible material itself.
2Device complexity
If free-hand implantation method is used, then the procedure can be performed without specialized guiding apparatus, but the risk of improper implantation increases
Solution Approach 1:
A delivery device serves as an intermediary between the surgeon and the implant, providing a simple yet effective guiding mechanism. The delivery device includes features such as a catheter or guide wire that directs the implant along the desired path, ensuring accurate placement without requiring complex specialized apparatus or advanced surgical skills.
Solution Approach 2:
The complex mechanical manipulation required for precise free-hand implantation is replaced by a simplified delivery system that uses basic mechanical principles (such as catheter-based delivery or pre-formed shapes) to achieve accurate placement through intuitive alignment with anatomical landmarks.
3Reliability
If sutures or straps are included with the implant, then the implant can be securely anchored to tissue, but the sutures may become tangled during implantation
Solution Approach 1:
The anchoring mechanism is segmented into separate functional components: the implant body and the anchoring elements (such as bars, hooks, or anchors). This segmentation allows the implant to be delivered and positioned first, with the anchoring elements being deployed separately afterward, eliminating the risk of tangling during the implantation process while maintaining secure anchoring capability.
Solution Approach 2:
The implant is delivered to the target location in a simplified configuration without pre-attached sutures or straps. The anchoring elements are prepared separately and attached or deployed after the implant is in position, performing the anchoring action preliminarily planned but executed separately to avoid interference during delivery.
4Manufacturing precision
If complex guiding apparatus are used to improve implantation accuracy, then improper implantation risk is reduced, but the device complexity and difficulty of the procedure increase
Solution Approach 1:
A relatively simple delivery device or guide catheter serves as an intermediary to provide adequate guidance for implant placement. The guiding apparatus is designed to be sufficiently complex to ensure accurate placement through features like pre-formed shapes, alignment markers, or catheter-based delivery, but not so complex as to require specialized training or complicated操作流程.
Solution Approach 2:
The guiding apparatus utilizes changes in physical parameters (such as the flexibility, diameter, or shape memory of the delivery catheter) to provide guidance functionality. By optimizing these parameters, the system achieves adequate guidance accuracy using simpler, more manageable equipment rather than complex mechanical guidance systems.
Data Source
AI summary
In one embodiment, a method includes securing an implant that includes a pre-formed loop to a vaginal apex. An end of the suture is inserted through a selected portion of a pelvic tissue to dispose at least a portion of the implant within a pelvic region of the patient. The end of the suture is drawn through the loop while simultaneously advancing a uterus to approximate the vaginal apex to the selected portion of pelvic tissue. An apparatus includes an implant and a suture coupled to the implant having a pre-formed loop. configured to receive a portion of a delivery device therethrough. A trocar is coupled to an end of the suture that can be releasably coupled to an end of the delivery device. The trocar can be inserted through a pelvic tissue and drawn through the loop forming a knot to secure the implant to the pelvic tissue.