Needle Removal Device for Low-Force Suture Extraction
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Solution Overview
Problem
Existing methods for achieving hemostasis at vascular puncture sites, such as manual compression and bioabsorbable sealing bodies, are inefficient, uncomfortable for patients, and can lead to complications like bleeding, hematoma, and pseudo-aneurysm formation, while suture applying devices face challenges in efficiently removing needles due to the need for manual force and insufficient needle holders.
Innovation Solution
A needle removal device with moveable members and receptacles that align and deform to securely grip and remove needles from a suturing device, allowing for efficient extraction with minimal force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding can be stopped, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The device segments the hemostasis function into multiple components: a puncture site closure device with deployable elements that can be independently activated, allowing localized closure without prolonged manual compression. The closure device can be deployed and secured in stages, reducing overall procedure time while maintaining reliable hemostasis.
Solution Approach 2:
The closure device is designed to achieve hemostasis through self-contained mechanical action rather than relying on prolonged external manual compression. Once deployed, the device maintains hemostasis autonomously through its structural design, eliminating the need for continuous manual pressure and reducing patient recumbency time.
2Reliability
If manual compression is applied to stop bleeding, then hemostasis can be achieved, but excessive pressure can occlude the blood vessel causing ischemia and thrombosis
Solution Approach 1:
The closure device applies pressure locally at the puncture site through deployable elements rather than through excessive global compression. This localized approach achieves hemostasis at the specific puncture location while maintaining adequate blood flow through the rest of the vessel, preventing ischemia and thrombosis.
Solution Approach 2:
The closure device acts as an intermediary between the puncture site and the blood vessel, providing controlled local pressure to achieve hemostasis without directly occluding the vessel lumen. The device elements are positioned to seal the puncture tract while leaving the vessel patent, eliminating the harmful effects of excessive compression.
3Reliability
If suture applying devices are used to close puncture sites, then hemostasis can be achieved, but needle removal requires manual force and insufficient needle holders
Solution Approach 1:
The device incorporates preliminary needle capture and retention features that are activated during the suturing process. Needles are captured in designated receptacles or by deformation mechanisms before suture deployment, making subsequent needle removal straightforward and eliminating the need for forceful manual extraction.
Solution Approach 2:
The device replaces manual needle extraction with an integrated mechanical release mechanism. The needle holder or receptacle is designed to automatically release or easily eject needles after suture deployment, substituting the need for manual force and improving ease of operation.
Data Source
AI summary
A method of removing needles operatively associated with suture through tissue surrounding an access tract, the method comprising advancing an elongate distal member along the access tract, locating an elongate proximal member in contact with tissue surrounding the puncture site, the elongate proximal member comprising a guide disposed within the elongate proximal member, a perimeter of the guide forming a plurality of needle receiving gaps that are circumferentially spaced about a needle deployment actuator with a portion of the guide disposed between adjacent needle receiving gaps extending outwardly towards a wall of the lumen of the elongate proximal member, the needle deployment actuator extending to the elongate distal member and being configured to initiate proximal movement of a needle toward an opening of the elongate proximal member, and actuating the needle deployment actuator to move the needle toward the opening of the elongate proximal member.


