Suturing Device Tissue Ports Guide Wire Closure
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Solution Overview
Problem
Current methods for closing arterial and venous puncture sites after medical procedures are inefficient, often resulting in substantial bleeding, require prolonged patient immobilization, and can lead to complications such as hematoma, pseudo-aneurysm, and vascular occlusion due to difficulties in accurately locating and securing the puncture site.
Innovation Solution
The development of suturing devices with tissue ports that allow for precise location and deployment of sutures over a guide wire, reducing needle miss-deployment and enabling rapid closure of larger body lumen openings, utilizing a shaft with needle exit openings and capture devices to secure sutures for effective hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to close the puncture site, then hemostasis can be achieved, but the patient must remain bedridden for a substantial period and it requires significant physician time
Solution Approach 1:
The suturing device performs preliminary suture placement and tissue approximation before the patient leaves the procedure room. The device pre-closes the puncture site with sutures and applies initial compression, so that hemostasis is established beforehand, eliminating the need for prolonged bedridden recovery.
Solution Approach 2:
The device enables self-contained puncture site closure by integrating suture delivery, tissue capture, and compression functions into a single automated system. The operator simply deploys the device, and it automatically performs the suturing and sealing actions without requiring prolonged manual compression or follow-up interventions.
2Reliability
If bioabsorbable fasteners or sealing plugs are used, then hemostasis can be achieved, but it is difficult to properly locate the interface of the overlying tissue and the adventitial surface
Solution Approach 1:
The device incorporates radiopaque markers and visual indicators that change appearance or become visible under imaging guidance, allowing the operator to precisely locate the tissue interface and adventitial surface. The shaft and foot member include radiopaque elements that highlight the deployment position and tissue engagement depth.
Solution Approach 2:
The device provides real-time feedback through radiopaque markers visible during fluoroscopy or other imaging, allowing the operator to monitor the position of the foot member relative to the tissue interface. This feedback mechanism ensures precise localization and proper engagement depth for reliable hemostasis.
3Reliability
If suture-applying devices are used, then puncture site closure can be achieved, but locating the tissue surrounding the puncture site can be difficult
Solution Approach 1:
The shaft and foot member include radiopaque materials and markers that are visible under imaging guidance, allowing the operator to easily detect and locate the tissue surrounding the puncture site. The radiopaque elements provide visual feedback on device position and tissue engagement.
Solution Approach 2:
The device uses the guidewire as an intermediary to navigate to the puncture site and provides a structured shaft with radiopaque markers as a mediator for visualizing tissue location. The shaft acts as an intermediary structure that bridges the operator's control and the tissue target, making location detection easier.
4Ease of operation
If the plug is placed too far from the tissue interface, then it can be easily deployed, but it results in failure to provide hemostasis and subsequent hematoma formation
Solution Approach 1:
The device provides real-time feedback through radiopaque markers and visual indicators that show the exact position of the foot member relative to the tissue interface during deployment. This feedback ensures the plug is placed at the correct depth to provide reliable hemostasis while maintaining ease of deployment through controlled advancement.
Solution Approach 2:
The device performs preliminary positioning and tissue engagement before final plug deployment. The foot member is first positioned against the tissue interface, then the plug is deployed at the predetermined correct depth, ensuring both ease of operation and reliable hemostasis.
Data Source
AI summary
A surgical device for suturing a body lumen is described, as well as methods for suturing tissue employing the surgical device. The device can include a body having a shaft and a foot for insertion into an opening in the body lumen. The device can include tissue ports between the shaft and the foot configured to receive tissue surrounding the opening in the body lumen. The foot can include a suture secured to needle capture devices. The device can include needles that can be advanced through tissue and into the needle capture devices. The needle capture devices can then be withdrawn, thereby harvesting the suture, which can then be used to close the opening in the body lumen.