Polyhedral Wound Closure Device with Spring Actuator
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Solution Overview
Problem
Existing methods for achieving hemostasis in cutaneous wounds are difficult, painful, time-consuming, and often require additional medical visits due to challenges with suture tension control and removal, especially around high-flow hemodialysis access sites.
Innovation Solution
A wound closure device featuring a polyhedral body with a suture channel and a spring-activated actuator system that allows for hands-free tensioning and securement of sutures, enabling easy deployment and removal without leaving behind sutures or requiring additional clinic visits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding control can be obtained, but the process becomes difficult, painful, and time-consuming
Solution Approach 1:
The suture is pre-positioned around the puncture site in a purse-string configuration before the needle is removed. This preliminary placement allows for rapid deployment and immediate application of circumferential tension to achieve hemostasis without time-consuming manual compression or knot-tying procedures.
Solution Approach 2:
The hollow needle serves as an intermediary delivery mechanism that carries the suture to the puncture site. By threading the suture through the needle lumen and forming a loop around the puncture site, the needle enables precise suture placement without requiring separate suturing steps, thereby reducing time and complexity.
2Reliability
If sutures are applied and knotted to close the wound, then hemostasis can be achieved, but removal becomes difficult and painful due to sutures becoming buried in tissues
Solution Approach 1:
The suture is extracted from the traditional knotted configuration and repositioned as a continuous loop around the puncture site. This loop configuration prevents the suture from becoming buried in tissues and allows for easy removal by simply pulling the free ends, eliminating the need to untie knots or dig out buried suture material.
Solution Approach 2:
The suture loop is pre-formed around the puncture site before final securing. This preliminary loop configuration ensures that the suture remains accessible and does not become embedded in the tissue, facilitating pain-free removal after the required dwell time for hemostasis.
3Reliability
If purse-string suture technique is used, then hemostasis can be promoted, but achieving precise tension on the sutures is challenging
Solution Approach 1:
The free ends of the suture extend beyond the puncture site, providing visual and tactile feedback that allows the operator to precisely control the tension applied to the purse-string loop. By adjusting the pull on the free ends, the operator can achieve and maintain the optimal tension required for effective hemostasis without excessive compression or insufficient closure.
Solution Approach 2:
The suture tension is made dynamic and adjustable rather than fixed. The free ends of the suture allow for real-time adjustment of tension levels, enabling the operator to optimize the purse-string tension during the procedure and adapt to different puncture site conditions, thereby achieving precise control over the closure force.
4Reliability
If sutures are left in place for 24-72 hours, then hemostasis is maintained, but additional medical visits are required for removal
Solution Approach 1:
The suture removal process is extracted from the clinical setting and made suitable for patient self-removal at home. By designing the suture with free ends that extend beyond the puncture site and are easily accessible, the invention enables patients to remove the sutures themselves after the required hemostasis period, eliminating the need for return visits to the clinic or hospital.
Solution Approach 2:
The suture design enables self-service removal by the patient. The free ends of the suture are positioned such that the patient can easily grasp and pull them to remove the entire suture loop without assistance from medical personnel, thereby converting a clinic-based procedure into a home-based self-care activity.
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 efficient and pain-free hemostasis by allowing precise tensioning and securement of sutures, reducing the need for manual compression and subsequent medical visits, while enabling rapid removal of the device and sutures once hemostasis is achieved.
Implementation Method 1
an actuator system including a spring-activated plunger
Data Source
AI summary
A wound closure device for promoting hemostasis includes a polyhedral body comprising a proximal body end portion and a distal body end portion, including a suture channel horizontally extending through the proximal and distal body end portions, the suture channel containing proximal and distal suture channel openings. An actuator system includes a suture engagement member configured to selectively facilitate axial movement or release of one or more sutures through the channel in an open configuration, and to facilitate securement of suture(s) in the channel in a locked configuration. The proximal body end portion includes a face configured to contact a body surface, anchoring the body to the body surface when suture(s) are secured under tension by the engagement member in the locked position. Once the sutures are secured, the device lends itself to hands-free anchoring until hemostasis is achieved. The device and sutures may then be removed that same day, shortly thereafter.