Introducer Sheath Hemostasis Valve Integral Adhesive Pad
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Solution Overview
Problem
Current methods for securing the proximal end of an introducer sheath to a patient's skin during vascular procedures are inefficient, requiring additional sterile packages, increasing procedure time, and posing discomfort and infection risks due to the use of sutures and separate adhesive pads, which are not as secure as a unified attachment.
Innovation Solution
An introducer sheath with a flexible adhesive pad integrated into the hemostasis valve at its proximal end, featuring a pressure-sensitive adhesive covered by a removable plastic sheet, allowing for rapid and secure attachment to the skin without additional parts, reducing skin penetration and infection risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a suture and needle are used to secure the introducer sheath to the skin, then the attachment is secure, but the procedure time increases and the risk of infection increases due to additional skin penetration
Solution Approach 1:
The adhesive pad is formed integral as one piece with the shell of the hemostasis valve, combining the attachment means with the valve structure. This eliminates the need for separate adhesive pads or sutures, reducing procedure time while maintaining secure attachment through the pressure-sensitive adhesive that bonds the valve directly to the skin
2Loss of time
If a separate adhesive pad is used to attach the introducer sheath, then the procedure time is reduced, but the holding security is insufficient compared to integral attachment
Solution Approach 1:
The adhesive pad is formed integral as one piece with the shell of the hemostasis valve, creating a unified structure where the adhesive cannot separate from the valve. This integral construction ensures that the adhesive pad moves with the valve and maintains secure attachment even under force, eliminating the risk of the valve slipping off a separate pad
3Reliability
If a suture is used to secure the sheath, then the attachment is reliable, but patient discomfort increases due to skin penetration
Solution Approach 1:
The mechanical suture and needle system is replaced with a pressure-sensitive adhesive system. The adhesive pad, formed integral with the hemostasis valve shell, bonds directly to the skin through adhesive forces rather than mechanical penetration, eliminating needle sticks and suture-related discomfort while maintaining secure attachment
4Ease of manufacture
If separate sterile packages are used for the adhesive pad and introducer sheath, then the components can be independently sterilized, but the costs increase and procedure complexity increases
Solution Approach 1:
The adhesive pad and hemostasis valve are formed as a single integral piece, eliminating the need for separate sterile packages. The unified structure can be sterilized as one unit, reducing the number of packages from two to one, simplifying the sterilization process, and reducing overall procedural complexity and cost
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
This solution significantly reduces procedure time, eliminates the need for separate sterile packages, enhances security by ensuring the hemostasis valve remains accurately positioned, and minimizes patient discomfort, while maintaining a secure attachment even under force.
Implementation Method 1
The adhesive pad has a pressure sensitive adhesive on one side that is covered by a removable plastic cover sheet which is removed to expose the pressure sensitive adhesive surface of the adhesive pad in order to attach the introducer sheath to the skin
Data Source
AI summary
An introducer sheath for placement of a tubular shaft into the vascular system of a human subject. The introducer sheath has a tubular shaft, a side arm, and a hemostasis valve placed at a proximal portion of the introducer sheath. The hemostasis valve has an adhesive pad formed integral with the shell of the hemostasis valve. The adhesive pad is designed to attach and detach a proximal section of the introducer sheath to and from the skin of the human subject.