Vascular Suturing Device with Needle Capture Trajectory
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression, are time-consuming, uncomfortable for patients, and prone to complications like bleeding, hematoma, and thrombosis, especially in anticoagulated patients or with larger introducer sheaths.
Innovation Solution
A suturing device with a flexible elongated member and multiple needle lumens, allowing for transapical insertion and suturing of body lumens, which includes a handle to retract needles and a barrel portion for secure suture placement, thereby facilitating efficient closure of vascular puncture sites.
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 observation
Solution Approach 1:
The suture is placed and secured in the tissue tract before the introducer sheath is fully removed, achieving hemostasis proactively rather than reactively. The free end of the suture is pulled to advance the needle and secure the suture in place, creating a pre-positioned hemostatic mechanism that eliminates the need for prolonged manual compression and observation
Solution Approach 2:
The patent extracts the hemostatic function from the manual compression process by using a separate suture-based mechanism. The suture is delivered through the introducer sheath and secured in the tissue tract, separating the hemostasis achievement from the sheath removal process, thereby reducing both compression time and observation time
2Reliability
If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient comfort deteriorates and complications increase
Solution Approach 1:
The suture acts as an intermediary mechanism between the introducer sheath and the tissue tract, providing a controlled method to secure the sheath and achieve hemostasis. Instead of direct manual compression on the patient's body, the suture mediates the hemostatic process by being secured in the tissue tract and pulled to advance the needle, reducing patient discomfort and complications
Solution Approach 2:
The suture system is self-securing through the tissue tract, eliminating the need for external manual compression. The free end of the suture is pulled to advance the needle and secure the suture in place, creating a self-sustaining hemostatic mechanism that reduces patient discomfort and the risk of complications associated with prolonged compression
3Ease of operation
If bioabsorbable sealing bodies are used to overcome manual compression problems, then patient comfort improves, but the sealing body may wander or move out of position causing late bleeds
Solution Approach 1:
The suture is placed and secured in the tissue tract before the introducer sheath is removed, creating a pre-positioned anchoring mechanism. This preliminary action ensures the sealing body remains securely positioned, preventing the wandering or displacement that causes late bleeds while maintaining patient comfort
Data Source
AI summary
A medical apparatus that includes a distal member, a needle disposed in the distal member and proximally advanceable from the distal member, and a needle capture portion positioned proximal to the distal member and which includes a through-hole to direct the needle from the needle capture portion towards a graspable member at a trajectory narrower than a trajectory of the needle from the distal member to the needle capture portion.