Suture-Based Vascular Closure with Hemostatic Plug
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for closing vascular access sites, such as manual compression, are time-consuming, uncomfortable for patients, and prone to complications like bleeding, hematoma, and pseudo-aneurysm formation, especially in larger sheath sizes or when patients are anticoagulated, and existing suture-based closure techniques require high skill and can result in minor oozing.
Innovation Solution
A device with an elongate body, a sheath, and hollow needles that deploy suture-anchors and hemostatic plugs to close the access passage, allowing for simpler and more effective closure without the need for complex suture retrieval, using a needle guide and advancement assembly to position the suture-anchors on either side of the access site, with hemostatic plugs providing additional sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used for hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires patient to remain recumbent for 4-12 hours
Solution Approach 1:
The device performs preliminary closure action by deploying a suture-based mechanism that pre-closes the access site before the patient needs to remain recumbent. The suture is deployed through the puncture site and tied to close the vessel opening, eliminating the need for prolonged manual compression and extended recumbency periods.
Solution Approach 2:
The patent introduces a suture as an intermediary element between the puncture site and the vessel wall. The suture acts as a mediator that mechanically closes the access site by tying off the vessel opening, replacing the need for direct manual compression and reducing both compression time and patient recovery time.
2Reliability
If manual compression is applied, then hemostasis is achieved, but excessive pressure can occlude the blood vessel causing ischemia and thrombosis
Solution Approach 1:
The device applies closure force locally at the puncture site through the suture mechanism rather than applying diffuse compression pressure across the entire access site. The suture is positioned to close only the specific vessel opening created by the needle puncture, allowing blood flow to continue through the rest of the vessel without occlusion, thereby preventing ischemia and thrombosis.
3Reliability
If suture-based closure is performed, then vessel closure is achieved, but the procedure requires high practitioner skill and proper suture deployment angles
Solution Approach 1:
The device incorporates a self-aligning mechanism where the suture is automatically positioned and deployed at the correct angle through the puncture site. The delivery system includes a needle guide and suture anchor that self-adjust to ensure proper suture placement without requiring the practitioner to manually control deployment angles, thereby reducing skill requirements while maintaining closure effectiveness.
4Adaptability or versatility
If the introducer sheath size is increased, then vascular access capability is improved, but the risk of complications from compression-induced hemostasis increases
Solution Approach 1:
The suture-based closure device performs preliminary closure of the access site immediately after sheath removal, regardless of sheath size. This preliminary action seals the puncture site before the patient is discharged, eliminating the need for prolonged compression and observation periods that are particularly risky for large-bore access sites, thereby improving hemostasis safety while preserving vascular access capability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device simplifies the closure process, reduces the risk of complications, and ensures effective hemostasis with minimal patient discomfort and skill requirements, providing a more reliable seal than single-fastener methods.
Implementation Method 1
When vascular access is no longer required, the introducer sheath is removed and bleeding at the puncture site stopped. One common approach for providing hemostasis (the cessation of bleeding) is to apply external force near and upstream from the puncture site
Implementation Method 2
A suture-anchor ejection mandrel is disposed within the hollow needle, which mandrel is also selectively advanceable through the hollow needle. A suture-anchor and suture may be disposed within the hollow needle, a distal end of the suture being attached to the suture-anchor for ejection out a distal end of the hollow needle by the mandrel
Data Source
AI summary
Devices for closing a passage through tissue communicating with a body lumen. The device may include an elongate body, a sheath disposed at the distal end of the device for disposition within a body lumen, a hollow needle disposed within a needle lumen of the body, the needle being selectively advanceable through the needle lumen, a suture-anchor ejection mandrel disposed within the hollow needle that is also selectively advanceable through the hollow needle, a suture-anchor and suture disposed within the hollow needle, a distal end of the suture attached to the suture anchor for ejection out the hollow needle by the mandrel. A needle guide disposed between the sheath and proximal end of the body may include a needle port through which the needle can exit. A hemostatic plug is disposed over the needle port so as to be penetrated by the needle upon exiting the port.