Resilient C-Shaped Staple for Needle-Free Tissue Closure
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Solution Overview
Problem
Current methods for closing percutaneous openings, such as those used in laparoscopy or gastropexy, often require suturing or manual pressure, which can be time-consuming, require patient immobilization, and pose risks of clot formation and damage to underlying body structures, especially in minimally invasive procedures where access is limited.
Innovation Solution
A medical device comprising a delivery tube, a control member, and a resilient C-shaped staple that can be deployed and expanded to pierce tissue without needles or sutures, allowing for quicker closure of openings while minimizing risk to underlying structures, using a resorbable or degradable material that absorbs or degrades during healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure is applied to close the puncture site, then clotting and wound sealing can occur, but the patient must remain immobilized for half an hour or more and may require prolonged hospital observation
Solution Approach 1:
The invention extracts the closure function from manual pressure application and implements it through a self-expanding staple device that automatically seals the puncture site, eliminating the need for prolonged manual compression and patient immobilization
Solution Approach 2:
The staple device is self-expanding upon deployment, automatically closing the puncture site without requiring continuous manual intervention or prolonged patient immobilization, allowing the patient to resume normal activity shortly after the procedure
2Reliability
If sutures are used to close larger puncture sites, then the opening can be securely closed, but the procedure becomes more complex and time-consuming requiring significant physician skill and practice
Solution Approach 1:
The invention replaces the complex manual suturing mechanical system with a self-expanding staple device that achieves secure closure through elastic expansion, eliminating the need for physician skill in tying knots or manipulating suture material
Solution Approach 2:
The staple's elastic properties and expansion ratio are engineered to provide secure closure force equivalent to or greater than manual suturing, while the delivery mechanism parameters are designed to simplify deployment compared to suture techniques
3Reliability
If purse-string sutures are used to close access sites, then the opening can be closed effectively, but damage to underlying body structures is a concern and proper suturing of fascia layers is difficult in key-hole procedures
Solution Approach 1:
The invention extracts the closure function from needle-based suturing and implements it through a needle-free self-expanding staple, eliminating the risk of needle-related damage to underlying structures and making the procedure feasible in key-hole access scenarios
Solution Approach 2:
The self-expanding staple acts as an intermediary device that achieves closure without direct manipulation of fascia layers or risk to underlying structures, providing a safe closure mechanism for minimally invasive procedures
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device facilitates faster and easier closure of tissue openings with reduced risk of damage, allowing for quicker patient recovery and minimizing the need for prolonged hospital stays, as it eliminates the need for sutures and manual pressure, promoting efficient and safe wound healing.
Implementation Method 1
The resilient material of the staple is elastically deformable such that the staple may flex to change a distance between the first and second tines
Implementation Method 2
using a resorbable or degradable material that absorbs or degrades during healing
Data Source
AI summary
The present invention provides devices for safely closing an opening in tissue. In one embodiment, the medical device includes a delivery tube, a control member and a staple. The delivery tube is elongated and extends from a proximal end to a distal end to define a longitudinal axis. The delivery tube defines a tube lumen, while the control member is elongated and extends through the tube lumen. The staple is releasably attached to the control member adjacent the distal end of the delivery tube. The staple formed of a resilient material having a C-shape, the C-shape including free ends defining first and second tines. The resilient material of the staple is elastically deformable such that the staple may flex to change a distance between the first and second tines. The free ends are spaced apart a first distance in an unbiased state of the staple.