Suture Connector Placement Device for Arteriotomy Closure
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Solution Overview
Problem
Current methods for closing arteriotomies after vascular catheterization procedures are inefficient, requiring prolonged recovery times, increased patient discomfort, and risk of complications due to the difficulty in securing and accessing suture ends to facilitate hemostasis.
Innovation Solution
A suture connector placement device and suture connector system that includes a handle, outer shaft, intermediate shaft, and push rod, allowing for the secure coupling of suture ends through a two-stage deployment process using a sleeve and plug mechanism, ensuring accurate positioning and secure closure of the arteriotomy without inadvertently pushing the connector through the vessel wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If compression is applied to the puncture site for 30-45 minutes to close the arteriotomy, then hemostasis is achieved, but patient recovery time increases and discomfort increases
Solution Approach 1:
The suture is pre-positioned through the arteriotomy site using a delivery catheter before the procedure is completed. The suture connector components are pre-loaded into the delivery device, ready for immediate deployment. This preliminary preparation eliminates the need for prolonged post-procedure compression and manual suturing, enabling faster hemostasis and patient recovery.
Solution Approach 2:
A suture connector serves as an intermediary device that couples the two suture ends together. The connector includes a body with a lumen for receiving the suture and a coupling mechanism that secures the suture ends. This intermediary device simplifies the hemostasis process by providing a mechanical solution that replaces prolonged compression, reducing both recovery time and patient discomfort while maintaining reliable hemostasis.
2Reliability
If manual tying of suture ends is performed to close the arteriotomy, then hemostasis is achieved, but procedure time increases and operational difficulty increases
Solution Approach 1:
The suture connector acts as an intermediary device that simplifies suture handling by providing a pre-designed coupling mechanism. Instead of requiring the physician to manually tie complex knots, the connector's body with lumen and coupling mechanism automatically secures the suture ends when deployed, maintaining reliable hemostasis while dramatically improving ease of operation.
Solution Approach 2:
The manual knot-tying mechanical system is replaced with a mechanically actuated deployment system. The delivery catheter with push rod mechanism automatically positions and deploys the suture connector at the target site, replacing the need for manual dexterity in tying sutures. This substitution maintains hemostatic reliability while significantly improving operational ease.
3Reliability
If a knot placement device is used to secure suture ends, then hemostasis is improved, but risk of inadvertently pushing connector through vessel wall increases
Solution Approach 1:
The suture connector is pre-positioned within the delivery catheter with controlled engagement features. The push rod mechanism is pre-configured with a limited stroke that stops before the connector can be pushed through the vessel wall. This preliminary design prevents the harmful effect of inadvertent over-pushing while maintaining effective hemostasis through secure connector deployment.
Solution Approach 2:
The delivery device incorporates a stop mechanism that provides preliminary anti-action against over-deployment. The push rod is designed with a controlled travel distance that prevents the connector from being forced through the vessel wall, counteracting the potential harmful effect before it can occur. This design maintains reliable hemostasis while eliminating the risk of vessel wall damage.
Data Source
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AI summary
A system (400) for forming a suture connector in situ includes a suture connector placement device having a handle (450), an outer shaft (464), an intermediate shaft (474), and a push rod (482), and a suture connector having a sleeve (406) and a plug (408). The intermediate shaft is slidingly disposed through a lumen of the outer shaft, and the push rod is slidingly disposed through a lumen of the intermediate shaft. When the suture connector is in a loaded configuration within the suture connector placement device, the sleeve is radially disposed between the intermediate shaft and the outer shaft and the plug is positioned proximal to the sleeve within the lumen of the intermediate shaft. Distal advancement of the push rod moves the plug into the sleeve and proximal retraction of the intermediate shaft releases the resilient sleeve onto the plug, thereby securing two suture portions between the sleeve and the plug.