Expandable Catheter Remodeling of Chronic Collagen Clots
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Solution Overview
Problem
Conventional methods for treating chronic clots and collagenous scar tissue in the vasculature are ineffective and often result in complications, as they struggle to remove these obstructions without damaging surrounding tissues, leading to issues like stent thrombus or re-occlusion, and surgical removal can cause vessel scarring.
Innovation Solution
The use of an expandable catheter with a conductive element to deliver controlled hydrogen ions, disrupting collagen crosslinks, followed by expansion of the catheter to remodel the obstruction, allowing for minimally invasive removal of chronic clots and scar tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional interventional techniques like angioplasty ballooning, debulking, and stenting are used to treat chronic clots, then the procedure can be performed minimally invasively, but the treatment is ineffective due to the difficulty of removing crosslinked collagen without disrupting vein walls
Solution Approach 1:
The patent applies electrical energy to change the chemical structure of crosslinked collagen by disrupting disulfide bonds through electrolysis and direct electrical breakdown, transforming the physical and chemical parameters of the collagen to make it removable. This resolves the contradiction by enabling effective removal of chronic clots while maintaining minimally invasive approach.
Solution Approach 2:
The patent replaces conventional mechanical methods (ballooning, debulking, stenting) with an electrical field-based approach using radiofrequency or pulsed electrical energy to disrupt collagen crosslinks. This substitution allows effective treatment of chronic clots without the mechanical disruption of vein walls, simultaneously achieving minimally invasive operation and treatment effectiveness.
2Reliability
If surgical removal of chronic clots is performed, then complete removal can be achieved, but significant tissue damage and vessel scarring occur
Solution Approach 1:
The patent replaces surgical mechanical removal with electrical energy application that selectively disrupts collagen crosslinks within the clot. This allows complete removal of chronic clots through chemical/physical breakdown of the collagen structure without mechanical disruption of surrounding healthy tissue, eliminating vessel scarring while achieving complete clot removal.
Solution Approach 2:
The patent applies electrical energy locally to the chronic clot through a catheter positioned at the treatment site. The electrical field is concentrated within the clot, selectively disrupting crosslinked collagen only where needed, while surrounding healthy tissue remains unaffected. This localized approach enables complete clot removal without damaging surrounding vessels.
3Reliability
If IVC filters are implanted to prevent pulmonary embolism, then patient protection is improved, but collagenous scar tissue builds up around the filter making removal difficult or impossible without disrupting vein walls
Solution Approach 1:
The patent uses electrical energy to disrupt the collagenous scar tissue that has built up around the IVC filter. By applying radiofrequency or pulsed electrical fields, the crosslinked collagen is broken down, allowing the filter to be removed without mechanical disruption of the vein wall. This resolves the contradiction by maintaining protection during implantation while enabling safe removal later.
4Reliability
If pacemaker or ICD leads are left in place, then patient monitoring and treatment continue, but collagenous scar tissue builds up around the leads making removal difficult or impossible without disrupting vein walls
Solution Approach 1:
The patent applies electrical energy to disrupt collagen crosslinks in the scar tissue surrounding pacemaker or ICD leads. This chemical/physical breakdown of the collagen matrix allows leads to be removed percutaneously without mechanical disruption of the vein wall, eliminating the harmful effect while maintaining the ability to remove leads when needed.
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 approach minimizes tissue damage and reduces recovery time by softening collagen obstructions, enabling faster and less invasive treatment of chronic clots and scar tissue, facilitating the removal of IVC filters and pacemaker/ICD leads.
Implementation Method 1
supplying energy to the conductive element, whereupon the energy reacts with water within the subject's vasculature and generates hydrogen ions that disrupt at least a portion of crosslinks within the collagen obstruction
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2
AI summary
The present disclosure relates generally to the use of medical devices for the treatment of chronic venous disease and collagenous scar tissue. In particular, the present disclosure provides methods and systems for remodeling a collagen obstruction using energy and an expandable catheter.