Inflatable Insertion Device for Percutaneous Valve Positioning
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Solution Overview
Problem
Current inflatable medical devices for heart valve replacements are operator-dependent and often result in incorrect placement or positioning, leading to potential embolization or incompetence of the replacement valve, and the use of occlusive deployment systems can stress the compromised heart, while trapped structures between the device and cavity walls pose risks during deployment and removal.
Innovation Solution
A locating device with inflatable insertion devices that are percutaneously introducible, featuring a non-compliant inflatable element and a flexible elongate member that can be withdrawn to allow the device to invaginate, reducing shear forces and enabling precise positioning and safe removal without causing embolization or dislodging of calcium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If expensive imaging systems such as echocardiography or fluoroscopy are used to locate and position the valve deployment device, then positioning accuracy is improved, but device complexity and cost increase
Solution Approach 1:
The patent replaces expensive imaging systems (echocardiography, fluoroscopy) with a tactile feedback mechanism. The distal end of the inflatable element provides direct mechanical/tactile feedback to the operator, allowing positioning based on tactile sensation rather than complex imaging systems. This substitutes a mechanical sensing approach for sophisticated optical/imaging systems.
Solution Approach 2:
The patent creates a simplified sensory interface that copies the essential positioning information needed from complex imaging systems. Instead of using full imaging systems, the distal end of the inflatable element provides a simplified tactile representation of the positioning state, allowing the operator to determine correct position through touch rather than complex visual imaging.
2Stability of the object's composition
If occlusive deployment systems such as inflatable balloons are used, then valve positioning stability is improved, but cardiac stress increases
Solution Approach 1:
The patent applies local quality by making only the distal end of the inflatable element occlusive, rather than the entire balloon. This localized occlusion provides sufficient positioning stability at the critical deployment site while minimizing the overall occlusive effect on cardiac output, thereby reducing cardiac stress.
Solution Approach 2:
The patent uses partial action by implementing occlusion only where necessary (at the distal end) rather than complete occlusion of the entire balloon. This partial occlusion provides adequate positioning stability without the excessive cardiac stress caused by complete occlusion, achieving the minimum necessary intervention.
3Stability of the object's composition
If the inflatable element is made rigid to maintain pre-set shape, then shape retention is improved, but ease of withdrawal deteriorates
Solution Approach 1:
The patent applies dynamics by making the inflatable element compliant rather than rigid. The element can dynamically change its mechanical properties: when inflated, it maintains its pre-set shape through internal pressure; when deflated, it becomes flexible and compliant, allowing easy withdrawal. This dynamic adaptation resolves the contradiction between shape retention and ease of withdrawal.
Solution Approach 2:
The patent changes the physical state parameter of the inflatable element by controlling inflation and deflation. When inflated, the element maintains rigidity and pre-set shape; when deflated, it becomes flexible for withdrawal. This parameter change (inflated/deflated state) allows the element to satisfy both contradictory requirements at different stages of the procedure.
4Reliability
If rapid ventricular pacing is performed to reduce cardiac output, then valve embolization risk is reduced, but additional cardiac intervention is required
Solution Approach 1:
The patent applies self-service by allowing the inflatable element to inherently prevent valve embolization through its mechanical engagement with the native valve anatomy. The element's design and tactile feedback mechanism provide self-stabilization, eliminating the need for additional procedural interventions like rapid ventricular pacing to prevent embolization.
Solution Approach 2:
The patent extracts the embolization prevention function from the procedural intervention (rapid ventricular pacing) and integrates it directly into the device design. The inflatable element's mechanical engagement and tactile feedback system inherently prevent embolization, removing the need for the separate pacing intervention.
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 solution allows for precise positioning of prosthetic valves with tactile feedback, reducing the need for imaging and minimizing cardiac stress, while ensuring safe removal by eliminating shear forces, thus preventing valve embolization and dislodging of calcium deposits.
Implementation Method 1
an inflatable element in the form of a small diameter elongate tube having a distal end and a proximal end and being operable between a collapsed condition and an inflated condition
Implementation Method 2
The elongate member is more flexible than the inflatable element when inflated to its pre-set desired shape
Data Source
Figure 1~3C
Figure 4~7
Figure 8~10C
AI summary
The invention provides an inflatable insertion device (10) capable of being percutaneously introduced into a patient's body. The insertion device (10) comprises an inflatable element (12) having a distal end (18) and a proximal end (16) and which is operable between a collapsed condition and an inflated condition by introducing an inflating fluid therein. An elongate member (22) extends internally of the inflatable element (12) from its distal end (18). The internal member (22) is capable of being withdrawn towards the proximal end (16) of the inflatable element (12) to result in the distal end (18) of the element (12) being withdrawn towards the proximal end (16) internally of the element (12). The invention further provides a locating device comprising a catheter having a catheter tube fitted with one or more inflatable insertion devices at a distal end thereof.