Introducer Sheath Lever Handle for Low-Force Valve Separation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The removal of introducer sheaths from a patient's body is cumbersome and can cause harm due to the high initial force required to break the hemostatic valve, especially when connected to medical devices.
Innovation Solution
An introducer sheath with a pivotable handle that utilizes a lever principle to reduce the breaking force needed, featuring a fulcrum and contacting portions to facilitate separation along its length, and optionally includes multiple handles for ergonomic handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the introducer sheath is designed with a hemostatic valve that requires high initial force to break, then the valve provides effective hemostasis, but the removal process becomes cumbersome and harmful to the patient
Solution Approach 1:
The introducer sheath is divided into two separable parts: a proximal portion that remains in the patient's body and a distal portion that is removed. The hemostatic valve is located in the distal portion and is designed to break at a predetermined line, allowing clean separation between the valve-containing distal portion and the proximal portion that stays in place.
Solution Approach 2:
A breaking element is introduced as an intermediary component between the hemostatic valve and the proximal portion. This breaking element is designed to fracture at a predetermined location, facilitating the separation of the distal portion from the proximal portion without requiring excessive force that could harm the patient.
2Strength
If the introducer sheath is made as a single intact structure, then it provides continuous support during insertion, but it cannot be easily separated for removal when connected to external medical devices
Solution Approach 1:
The introducer sheath is segmented into a proximal portion and a distal portion connected by a breaking element. During insertion, the entire structure functions as a single unit providing continuous support. For removal, the breaking element fractures at a predetermined line, allowing the distal portion to be separated and removed while the proximal portion remains in place.
Solution Approach 2:
The breaking element is pre-designed with a predetermined breaking line during manufacturing. This preliminary preparation ensures that when separation is needed, the breaking element will fracture at the intended location without requiring complex manual separation techniques or excessive force.
3Ease of operation
If high force is applied to break the hemostatic valve, then the introducer sheath can be separated, but the medical device may be inadvertently retracted causing harm to the patient
Solution Approach 1:
The breaking element serves as an intermediary that absorbs the breaking force. It is designed to fracture at a predetermined line between the distal and proximal portions, isolating the breaking action from the medical device. This allows the distal portion to be removed without transmitting excessive force to the medical device, preventing inadvertent retraction.
Solution Approach 2:
The breaking element is designed to be extracted or fractured at a specific location, separating the breaking function from the medical device. By positioning the breaking element in the distal portion away from the medical device connection point, the breaking action is extracted from the critical area where device retraction could occur.
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 introducer sheath design reduces the force required for separation, improving handling and minimizing patient harm by distributing the breaking force effectively.
Implementation Method 1
at least one handle which is pivotable about a fulcrum, the handle having a first end portion and a free second end portion so as to form a lever. Pivoting the handle about the fulcrum causes a contacting portion of the handle to act on a respective counter portion that is operatively connected to the distal portion of the tubular body, thereby creating a breaking force
Data Source
AI summary
An introducer sheath for providing access in a patient's body comprises a tubular body with a distal portion and a proximal portion, the proximal portion being configured to be inserted into the patient's body to allow a medical device to be inserted through the introducer sheath into the patient's body. In order for the introducer sheath to be removable from the patient, it can be separated along its length in a longitudinal direction. The introducer sheath further comprises at least a first handle which is pivotable about a fulcrum. The first handle has a first end portion and a free second end portion so as to form a lever, such that pivoting the handle about the fulcrum causes a contacting portion of the handle to act on a respective counter portion that is operatively connected to the distal portion of the tubular body. This creates a breaking force that causes the distal portion of the tubular body to break.