Expandable Balloon With Slidable Constraint For Lesion Treatment
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Solution Overview
Problem
Vascular dilatation balloons face challenges in maintaining uniform pressure and precise positioning during lesion treatment, with noncompliant balloons risking damage to surrounding tissues and compliant balloons inflating unevenly, leading to inadequate stenosis alleviation.
Innovation Solution
A medical device featuring an elongated tubular body with a slidable constraint that allows for preferential inflation of different sections of the expandable element, enabling controlled expansion and maintaining position within the body lumen, using materials like polytetrafluoroethylene (PTFE) for the constraint to ensure biocompatibility and lubricity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a noncompliant balloon is used to maintain uniform pressure during inflation, then the inflation profile remains predictable and damage to surrounding lumen is minimized, but the balloon cannot expand uniformly around calcified lesions and may fail to break them effectively
Solution Approach 1:
The balloon is divided into multiple independent inflatable zones (first inflatable zone and second inflatable zone) that can be inflated separately. This segmentation allows selective application of high pressure to specific lesion areas while maintaining overall profile control, resolving the contradiction between uniform pressure and lesion-breaking strength.
Solution Approach 2:
Different zones of the balloon are designed with different compliance characteristics - the first inflatable zone is more compliant to conform to irregular lesion surfaces, while the second inflatable zone maintains noncompliant characteristics for stable positioning. This local differentiation enables both uniform overall pressure and localized high pressure for lesion fracture.
2Adaptability or versatility
If a compliant balloon is used to expand and conform to the lesion shape, then the balloon can adapt to irregular surfaces, but it inflates unevenly forming an hourglass shape that damages the lumen and fails to alleviate stenosis
Solution Approach 1:
The balloon is divided into multiple independently controllable zones that can be inflated in a controlled sequence. This prevents the simultaneous uniform expansion that causes hourglass formation, allowing the balloon to adapt to lesion contours while maintaining even overall pressure distribution and preventing lumen damage.
Solution Approach 2:
The first inflatable zone is inflated initially to establish contact with the lesion surface and provide a foundation for subsequent inflation. This preliminary action prevents uneven expansion by pre-positioning the balloon correctly before the second zone is inflated, avoiding hourglass formation and lumen damage.
3Length of moving object
If the balloon is positioned at the distal end of the catheter for lesion treatment, then it can reach the target site, but it is difficult to maintain proper positioning within the lesion during inflation
Solution Approach 1:
The balloon's segmented structure with multiple inflatable zones creates differential expansion patterns that generate anchoring forces against the vessel wall. This segmentation allows the balloon to maintain stable positioning within the lesion during inflation while still being deliverable through the catheter to the target site.
Solution Approach 2:
Different zones of the balloon have different compliance properties - the first zone is more compliant to conform to and anchor against the lesion surface, while the second zone maintains structural integrity for stable positioning. This local quality differentiation enhances positioning reliability during inflation.
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 control of balloon expansion, reducing tissue damage and improving the effectiveness of vascular dilatation by maintaining uniform pressure and precise positioning, enhancing the treatment of lesions with improved working length adjustment and force distribution.
Implementation Method 1
a slidable constraint can comprise at least two portions, each surrounding a section of the expandable element. Upon expansion of the expandable element, the portions of the slidable constraint slide away from the middle region of the expandable element in opposing directions
Implementation Method 2
the portions of the slidable constraint slide away from the middle region of the expandable element in opposing directions toward the distal end or proximal end of the expandable element so that in the fully expanded state, one portion of the slidable constraint is compressed at the distal end of the expandable element and the other portion of the slidable constraint is compressed at the proximal end of the expandable element
Implementation Method 3
Noncompliant balloons exhibit a substantially uniform exterior inflated profile which remains substantially unchanged upon increasing inflation pressures. Noncompliant balloons have been suggested to be advantageous because they allow the introduction of increased inflation pressure to break calcified lesions
Implementation Method 4
using materials like polytetrafluoroethylene (PTFE) for the constraint to ensure biocompatibility and lubricity
Data Source
AI summary
A medical device with an expandable element and slidable constraint of at least two portions surrounding the expandable element which slides away from the middle region and toward the distal and proximal ends of the expandable element upon expansion of the expandable element to influence the rate, shape and/or force required to expand the expandable element and methods for use in a body lumen are provided.