Body Lumen Puncture Closure With Deployable Suture Needles
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Solution Overview
Problem
Existing methods for closing body lumen punctures, such as manual compression and bioabsorbable sealing bodies, are inefficient, uncomfortable, and prone to complications like bleeding, hematoma, pseudo-aneurysm formation, and vascular occlusion, especially in anticoagulated patients.
Innovation Solution
A device with an elongate member and a foot portion that deploys needles to suture the puncture site, using a foot that moves between delivery and deployed positions to secure sutures and close the opening effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The closure device performs hemostasis action in advance by deploying sutures and sealing structures during the catheter removal process itself, rather than requiring separate prolonged compression procedures afterward. The device pre-establishes closure mechanisms that stop bleeding immediately upon deployment.
Solution Approach 2:
The invention replaces the manual mechanical compression system with an automated suture-based closure device that uses controlled mechanical forces through needles and sutures to achieve hemostasis, eliminating the need for prolonged manual pressure application.
2Reliability
If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient comfort deteriorates and complications increase
Solution Approach 1:
The closure device extracts the hemostasis function from the manual compression process by providing an independent mechanical closure system that operates separately from patient positioning and manual pressure application, thereby eliminating associated discomfort and complications.
Solution Approach 2:
The suture and sealing structures act as intermediaries between the puncture site and the external environment, providing a controlled closure mechanism that avoids direct manual compression on the patient's body and reduces associated harmful effects.
3Reliability
If bioabsorbable sealing bodies are used to close punctures, then hemostasis is achieved, but the sealing bodies may wander or move out of position causing late bleeds
Solution Approach 1:
The invention merges the suture anchoring function with the sealing body, creating an integrated closure system where the suture mechanically secures the sealing material to the tissue, preventing wandering or displacement while maintaining hemostasis.
Solution Approach 2:
The suture is deployed in advance to establish mechanical anchoring before the sealing body is fully positioned, ensuring stable fixation that prevents late displacement and recurrent bleeding.
4Adaptability or versatility
If larger introducer sheaths are used for vascular access, then procedural capability is improved, but the risk of complications from manual compression increases
Solution Approach 1:
The automated suture-based closure device replaces the manual compression system, providing reliable hemostasis for larger puncture sites created by bigger introducer sheaths without the increased complication risks associated with manual compression of larger vessels.
Data Source
AI summary
A device for closing an opening in a body lumen, the device having a first elongate member with a first lumen, a second elongate member distal the first elongate member, and a needle assembly slidably cooperating with the first elongate member to position a plurality of sutures within the lumen of the first elongate member. The needle assembly includes a needle base and a plurality of needle portions extending from the needle base. Slidable movement of the needle assembly in relation to the first elongate member locates the plurality of sutures selectively mounted to the needle assembly within the first lumen.