Body Lumen Closure Foot and Needle Assembly for Rapid Hemostasis
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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, and vascular occlusion, particularly 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 for hemostasis, ensuring a solid mechanical attachment.
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 device divides the closure function into multiple independent components: an elongate member for access, a foot portion with multiple feet for positioning, and multiple needles for suture placement. Each component performs a specific function, allowing simultaneous action at multiple points along the vessel wall to achieve rapid closure without prolonged compression
Solution Approach 2:
The device pre-forms sutures within the elongate member before insertion. The feet and needles are pre-positioned and pre-loaded, allowing immediate deployment upon insertion without requiring time-consuming setup or adjustment during the procedure
2Reliability
If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient comfort deteriorates and analgesics are required
Solution Approach 1:
The invention replaces the mechanical compression system (external pressure applied by personnel) with a biological suturing system (needles threading suture material through tissue). This substitution eliminates the need for excessive external pressure that causes patient discomfort while achieving more precise and gentle tissue approximation
3Reliability
If excessive compression pressure is applied to achieve hemostasis, then bleeding stops, but vascular occlusion and thrombosis occur
Solution Approach 1:
The device applies closure action locally at the puncture site through precisely positioned needles and feet. The suture material is placed only where needed to approximate the puncture edges, leaving the rest of the vessel lumen completely open and unaffected. This localized action eliminates the risk of total vascular occlusion that occurs with excessive external compression
4Adaptability or versatility
If the introducer sheath size is increased to accommodate larger devices, then more complex procedures can be performed, but the incidence of complications from manual compression increases
Solution Approach 1:
The device incorporates dynamic elements including movable feet that can extend and retract, and needles that can be advanced and retracted within the elongate member. This dynamic design allows the device to adapt to different vessel sizes and puncture configurations without requiring larger sheath sizes, maintaining versatility while reducing trauma to the access site
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.