Variable Repositioning Sheath for Arteriotomy Gap Sealing
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Solution Overview
Problem
Existing intracardiac blood pump systems face issues with annular gaps and bleeding due to fixed or expandable introducer sheaths, which can lead to thrombosis and discomfort, as they do not effectively seal the arteriotomy and accommodate varying vessel sizes.
Innovation Solution
A variable size repositioning sheath with adjustable radial dimensions, using mechanisms like ratchet-type, star-shaped, or cam-type components, to fit seamlessly into both peel-away and expandable introducer sheaths, sealing the arteriotomy and minimizing bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid fixed diameter introducer sheath is used to accommodate the pump assembly, then the pump assembly can be inserted, but the sheath leaves an annular gap causing bleeding and thrombosis
Solution Approach 1:
The patent applies a dynamic sizing mechanism where the repositioning sheath can be adjusted from a compressed delivery state to an expanded sealing state. The sheath includes expandable elements that allow it to adapt its diameter to match the arteriotomy size, eliminating the fixed diameter limitation and preventing annular gaps.
Solution Approach 2:
The patent changes the dimensional parameter of the repositioning sheath from a fixed small diameter (for delivery) to a variable larger diameter (for sealing). This parameter change allows the sheath to first pass through the introducer sheath easily, then expand to fill the arteriotomy and prevent bleeding.
2Ease of operation
If a larger introducer sheath is used to accommodate the pump assembly, then the pump can be inserted, but the arteriotomy remains open causing limb ischemia and discomfort
Solution Approach 1:
The repositioning sheath is designed to be inserted within the introducer sheath, creating a nested configuration. The repositioning sheath can be compressed to fit through the introducer sheath lumen, then expanded at the distal end to seal the arteriotomy, effectively using the introducer sheath as a delivery tube while eliminating the need for a large permanent opening.
Solution Approach 2:
The repositioning sheath transitions from a compressed state during insertion to an expanded state for sealing. This dynamic transformation allows the system to use a small introducer sheath for insertion while achieving effective arteriotomy closure afterward.
3Object-generated harmful factors
If an expandable introducer sheath is used to reduce arteriotomy size, then bleeding is reduced, but the sheath may not tighten down on the catheter hub
Solution Approach 1:
The repositioning sheath acts as an intermediary element between the expandable introducer sheath and the catheter hub. It is inserted over the catheter hub and configured to tighten down specifically on the hub, providing a reliable seal that the introducer sheath alone cannot achieve.
4Object-generated harmful factors
If a repositioning sheath is inserted to fill annular gaps, then bleeding is reduced, but the sheath must be adjusted to fit varying vessel sizes
Solution Approach 1:
The repositioning sheath incorporates expandable elements that allow it to change its diameter dynamically. It can be compressed for insertion through smaller vessels and expanded to match larger arteriotomies, providing adaptability across different patient anatomies while maintaining gap closure functionality.
Data Source
AI summary
Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.