Introducer Sheath Recoil Section for Vascular Access
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Solution Overview
Problem
Large diameter introducer sheaths for vascular access pose a risk of tissue recoil and bleeding due to their size, which can lead to complications and prolonged healing times, as they dilate the vessel and surrounding tissue, making it difficult for the tissue to return to its original configuration.
Innovation Solution
An introducer sheath with a recoil section that has higher radial compressibility than the rest of the tubular body, allowing the tissue to recoil and reduce the risk of bleeding by constricting the opening at the puncture site, while maintaining the stiffness needed for insertion and anchoring within the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a large diameter introducer sheath is used to access the vessel, then the inner diameter is sufficient to allow medical devices to pass through, but the outer diameter causes significant tissue dilation and recoil leading to bleeding and prolonged healing
Solution Approach 1:
The introducer sheath incorporates a recoil section with distinct material properties (higher radial compressibility, softer characteristics) at a specific location where it contacts the puncture site tissue. This localized variation in material quality allows the sheath to accommodate tissue recoil at the critical interface while maintaining structural integrity and adequate inner diameter elsewhere in the device.
2Object-affected harmful factors
If the introducer sheath diameter is minimized to reduce tissue harm, then tissue recoil and bleeding are reduced, but the inner diameter becomes insufficient to allow larger medical devices to pass through
Solution Approach 1:
The sheath features a localized recoil section with modified material properties that provides adequate radial compliance only where needed at the puncture site interface. The rest of the sheath maintains sufficient structural dimensions to accommodate large-bore medical devices, achieving both tissue protection and device compatibility through spatially differentiated material properties.
3Ease of operation
If the introducer sheath is made stiffer to facilitate insertion and anchoring, then insertion and positioning are easier, but the sheath prevents tissue recoil and increases bleeding risk
Solution Approach 1:
The introducer sheath incorporates a recoil section with distinct material properties (higher radial compressibility, softer characteristics) at a specific location where it contacts the puncture site tissue. This localized variation in material quality allows the sheath to accommodate tissue recoil at the critical interface while maintaining structural integrity and adequate inner diameter elsewhere in the device.
Solution Approach 2:
The sheath is divided into functional segments with different mechanical properties: a stiffer proximal portion for insertion and anchoring, and a softer recoil section for tissue accommodation. This segmentation allows each portion to optimize its function without compromising the other.
4Object-affected harmful factors
If the introducer sheath is made softer to allow tissue recoil, then healing is improved and bleeding is reduced, but the sheath becomes difficult to insert and anchor
Solution Approach 1:
The introducer sheath incorporates a recoil section with distinct material properties (higher radial compressibility, softer characteristics) at a specific location where it contacts the puncture site tissue. This localized variation in material quality allows the sheath to accommodate tissue recoil at the critical interface while maintaining structural integrity and adequate inner diameter elsewhere in the device.
Solution Approach 2:
The sheath is divided into functional segments with different mechanical properties: a stiffer proximal portion for insertion and anchoring, and a softer recoil section for tissue accommodation. This segmentation allows each portion to optimize its function without compromising the other.
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 recoil section facilitates tissue recoil, reduces bleeding, and provides a plug-like effect to seal the vessel, improving healing and reducing the risk of complications, while allowing flexibility in insertion and positioning of medical devices.
Implementation Method 1
the tubular body has a recoil section which has a radial compressibility that is higher than a radial compressibility of at least a portion of the tubular body that is distal to the recoil section
Data Source
AI summary
An introducer sheath for providing vascular access in a patient's body comprises a tubular body having a proximal end and a distal end, the distal end being configured to be inserted into a patient's vessel to allow a medical device to be inserted from the proximal end through the tubular body out of the distal end into the patient's vessel. The tubular body includes a recoil section that has a radial compressibility which is higher than a radial compressibility of at least a portion of the tubular body that is distal to the recoil section. This enables the patient's vessel and surrounding tissue to recoil at the puncture site, which is advantageous for the patient, e.g. with respect to wound healing.