Multi-cellular Closure Device for Minimally Invasive PFO Repair
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Solution Overview
Problem
Conventional treatments for Patent Foramen Ovale (PFO) and similar cardiac defects often require invasive surgery, which poses risks and is less efficient in closing the tissue opening effectively.
Innovation Solution
A medical system comprising a closure device with a multi-cellular body and anchors that can be deployed to approximate tissue, including a delivery device with a handle body, actuating assembly, and release assembly, allowing for selective positioning and detachment of the closure device within the internal tissue opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical procedures are used to close PFO, then the tissue opening can be closed, but the treatment becomes invasive and carries surgical risks
Solution Approach 1:
A closure device acts as an intermediary element between the two atrial walls. The device includes anchors that engage with the tissue and a body portion that bridges the opening, allowing closure without direct surgical intervention. The delivery device serves as another intermediary to transport and deploy the closure device minimally invasively through catheter-based access.
Solution Approach 2:
The invention replaces the mechanical surgical system (knives, sutures, direct tissue manipulation) with a deployable closure device system. The closure device uses elastic anchors and a flexible body portion that can be delivered through a catheter and deployed to close the opening, substituting complex surgical mechanics with a simpler, less invasive deployment mechanism.
2Reliability
If invasive surgery is performed to close the PFO, then the opening can be closed, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The closure device is segmented into distinct functional components: anchors with engaging members, a body portion with cells, and a delivery device with separate assemblies. This segmentation allows each component to be optimized for its specific function and enables stepwise deployment, reducing overall procedural complexity compared to traditional surgery.
Solution Approach 2:
The closure device is prepared and loaded into the delivery device before patient insertion. The anchors are pre-positioned on the body portion, and the entire assembly is sterilized and ready for deployment. This preliminary preparation simplifies the actual procedural steps during the intervention, reducing complexity compared to intra-procedural assembly required in surgery.
3Reliability
If traditional surgical methods are used, then the tissue opening can be closed, but patient safety is compromised due to invasive risks
Solution Approach 1:
The closure device serves as a biocompatible intermediary that physically closes the PFO without requiring direct surgical contact with the patient's tissue. The delivery device acts as a second intermediary, allowing the closure device to be inserted through a catheter in a large vessel, avoiding the need for open chest surgery and associated risks.
Solution Approach 2:
The invention changes the physical parameters of the intervention: instead of high-invasiveness parameters (open surgery, direct tissue cutting), the system uses low-invasiveness parameters (catheter-based delivery, non-cutting deployment). The closure device transitions from a compressed low-profile state during delivery to an expanded closure state at the target site, changing geometric parameters to achieve closure safely.
Data Source
AI summary
A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. A segment can define a variable width along a length of the segment to have a substantially equal stress level along the length when deflected. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together for closure. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device. The closure device can also include a member adapted to induce tissue growth.