Internal Balloon Sheath for Catheter Sealing and Clot Prevention
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Solution Overview
Problem
Intravascular medical devices experience blood stagnation and clotting due to the space between the introducer sheath and the catheter body, leading to potential embolization and positioning issues, which current solutions complicate the procedure with continuous fluid flow and external fixation.
Innovation Solution
A sheath with an internal inflatable balloon that seals the lumen and forms an interference fit with the catheter, preventing blood ingress and securing the device's position, eliminating the need for continuous fluid flow and external fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous fluid flow is used to prevent clotting, then clotting is prevented, but procedure complexity and fluid management requirements increase
Solution Approach 1:
The patent removes the need for continuous fluid flow by introducing an inflatable balloon that physically seals the space between the sheath and catheter. The balloon is inflated to create a barrier that prevents blood ingress and stagnation, eliminating the requirement for ongoing fluid delivery systems to prevent clotting.
Solution Approach 2:
The inflatable balloon acts as an intermediary element between the sheath and catheter. When inflated, it creates a sealed barrier that prevents direct contact between blood and the space between these components, thereby preventing clotting without requiring continuous fluid flow.
2Stability of the object's composition
If external fixation is used to stabilize device position, then positioning stability is improved, but device complexity and bulk increase
Solution Approach 1:
The inflatable balloon serves as an intermediary that provides internal stabilization. When inflated, it creates a barrier that prevents the catheter from moving relative to the sheath, thereby stabilizing device position without requiring external fixation mechanisms.
Solution Approach 2:
Instead of using external fixation to stabilize the device, the patent inverts the approach by using an internal inflatable balloon to provide stabilization from within the sheath-catheter assembly, eliminating the need for external fixation mechanisms.
3Duration of action of stationary object
If the sheath is designed for long term use, then device durability is improved, but clotting risk increases due to space between sheath and catheter
Solution Approach 1:
The patent removes the harmful space between the sheath and catheter by introducing an inflatable balloon that fills this gap. When inflated, the balloon eliminates the void that would otherwise allow blood stagnation and clotting, enabling long-term use without these complications.
Solution Approach 2:
The inflatable balloon acts as an intermediary that prevents blood from stagnating in the space between the sheath and catheter. By creating a sealed barrier, it eliminates the conditions that lead to clotting, thereby enabling safe long-term use of the sheath.
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 internal balloon sheath effectively prevents clotting and stabilizes the catheter position, simplifying the procedure by sealing the lumen and allowing for secure fixation without additional fluid flow or bulky external attachments.
Implementation Method 1
the balloon configured to occupy a longitudinal space in the lumen between the inner surface of the sheath body and the catheter device when the catheter device is disposed within the sheath and the balloon is inflated, and fluidically seal the lumen
Data Source
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AI summary
Devices and methods for providing an internal balloon sheath are disclosed. One device includes a sheath (400) for insertion through an arteriotomy of a patient. The sheath comprises a tubular sheath body (402) having a longitudinal axis, an open proximal end, an open distal end, an outer surface and an inner surface, the inner surface defining a lumen between the proximal and distal ends for passage of a catheter device. The sheath also comprises an inflatable balloon (410) disposed within the lumen. The inflatable balloon is configured to occupy a longitudinal space in the lumen between the inner surface of the sheath body and the catheter device (422) when the catheter device is disposed within the sheath and the balloon is inflated, and fluidically seal the lumen.