Fixation Device Head Design for Soft Tissue Anchoring
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Solution Overview
Problem
Existing methods for treating conditions like rectocele, cystocele, and stress urinary incontinence require bone anchors that are not suitable for soft tissues and often involve invasive procedures, as they either cause irritation or require abdominal incisions.
Innovation Solution
A fixation device and delivery instrument system that allows for secure placement of fixation devices within tissues or ligaments using a carrier and catch mechanism, enabling minimally invasive procedures without the need for bone anchors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If bone anchors with barbs are used for fixation, then anchoring strength in bone is improved, but tissue irritation and damage occur in soft tissues
Solution Approach 1:
The fixation device features a head portion with a larger cross-sectional area than the shaft portion, creating local structural differentiation. The head acts as an anchor while the narrower shaft minimizes tissue disruption during insertion and extraction, resolving the contradiction between anchoring strength and tissue irritation
Solution Approach 2:
Instead of using barbs that protrude outward to prevent extraction (traditional approach), the invention inverts the approach by using friction between the shaft and tissue cavity, combined with a head that is too large to pass through the cavity, preventing extraction without causing tissue damage from protruding elements
2Reliability
If bone anchors are used for sling fixation, then secure anchoring is achieved, but invasive procedures such as abdominal incisions are required
Solution Approach 1:
The fixation device serves as an intermediary between the sling and the tissue, using a shaft that can be inserted through a small incision to deliver the head portion to the target location. The head then expands or engages to provide secure anchoring without requiring large incisions or complex bone drilling procedures
Solution Approach 2:
The invention extracts the anchoring function from the shaft and concentrates it in the head portion, allowing the shaft to be a simple delivery mechanism that can be removed after deployment, leaving only the head embedded in tissue for anchoring the sling
3Strength
If barbed anchors are implanted in soft tissue, then anchoring capability is achieved, but the anchors tear through tissue and cause irritation
Solution Approach 1:
The shaft is designed with flexible properties that allow it to conform to the tissue cavity shape, distributing pressure evenly and preventing tissue tearing. The flexible shaft can be inserted through small incisions and maintains position through friction rather than rigid anchoring elements
Solution Approach 2:
The fixation device has asymmetric geometry with a head portion that is larger than the shaft portion. This asymmetry allows the head to provide anchoring strength while the narrower shaft minimizes tissue disruption during insertion and extraction, preventing the tearing issues associated with symmetric barbed designs
Data Source
AI summary
A fixation device can be delivered to the body of a patient by coupling the fixation device to a delivery instrument at a head of the fixation device. Engaging the fixation device to the delivery instrument at the fixation device's head allows the fixation device to be secured to a tissue and/or ligament of the patient. The fixation device can be a sling for placement around the bladder neck of a female patient.