Splittable Sheath Valve for Secure Vascular Access
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Solution Overview
Problem
Existing vascular access devices lack ease and safety of use for physicians and healthcare providers when inserting catheters or sheaths into blood vessels.
Innovation Solution
The development of an access device featuring a splittable sheath with a valve element and a resilient plate for sealing, along with a needle and dilator, to facilitate the insertion and sealing of medical articles into body spaces, enhancing the ease and safety of the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional access device without a valve is used, then the device structure is simple, but blood leakage occurs during the procedure
Solution Approach 1:
The valve element is pre-positioned within the sheath body at a location that will be at or near the puncture site. The resilient plate with sealing portion is already in place to seal against the outer surface of the sheath body, so the sealing mechanism is prepared before the procedure begins, eliminating the need for complex assembly during the procedure while preventing blood leakage.
2Ease of operation
If a non-splittable sheath is used, then the sheath structure is simple, but removal and disposal is difficult and time-consuming
Solution Approach 1:
The sheath is designed with a frangible portion that creates a predetermined break line, allowing the sheath to be segmented into two portions. The first portion contains the valve element and can be removed from the patient's body, while the second portion remains inside. This segmentation enables easy removal of the critical components without requiring complex disassembly procedures.
Solution Approach 2:
The frangible portion with predetermined break line is built into the sheath structure before use. The scoring line or weakened section is pre-formed so that when force is applied during removal, the sheath breaks at the predetermined location rather than requiring complex manual disassembly or cutting procedures.
3Reliability
If the sealing element constantly contacts the needle and dilator, then sealing is maintained, but friction and device wear increase
Solution Approach 1:
The sealing element is designed to be movable rather than fixed, allowing it to dynamically adjust its position. The resilient plate can flex and move radially to maintain contact with the sheath body while minimizing friction during the insertion and removal of needles and dilators. The sealing element moves with the components rather than resisting their motion constantly.
Solution Approach 2:
The sealing element maintains contact with the sheath body at critical moments (during insertion and when not in use) but is designed to clear or minimize contact during the actual passage of needles and dilators. The sealing action is applied partially - only when needed for sealing - rather than continuously, reducing unnecessary friction and wear during instrument passage.
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 access device provides a more efficient and secure method for inserting medical articles into body spaces, improving user experience and reducing the risk of complications during vascular access procedures.
Implementation Method 1
The valve element can include a resilient plate including a sealing portion extending radially inwardly from a side of the inner cavity. The valve element can include a sealing element including a first sealing surface supported by the resilient plate such that the sealing element is biased toward a position against a second sealing surface
Data Source
AI summary
A splittable sheath includes a splittable sheath body, a splittable sheath hub, and a valve element. The sheath body comprises a generally flexible tubular structure, a proximal end, and a distal end. The sheath body defines a longitudinal axis and is splittable into two halves along a pre-determined line generally parallel to the longitudinal axis. The sheath hub extends from the proximal end of the sheath body and defines a longitudinal axis generally aligned with the longitudinal axis of the sheath body. The sheath body and sheath hub form an inner cavity along their respective longitudinal axes. The valve element includes a resilient plate and a sealing element. The resilient plate includes a distal portion extending radially inwardly from a side of the inner cavity. The sealing element includes a sealing surface and is supported by the resilient plate such that the sealing element is biased toward a position against a second sealing surface on at least one of the splittable sheath body and hub to substantially seal the inner cavity.