Dual-Balloon Catheter for Isovolumetric Thrombus Containment
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Solution Overview
Problem
Current endovascular devices lack a tailored solution for treating massive and sub-massive pulmonary embolisms (PE) and deep vein thrombosis (DVT), with limitations including ineffective localized thrombolysis, risk of venous wall damage, and high morbidity from venous thromboembolism (VTE) and post-thrombotic syndrome (PTS).
Innovation Solution
A balloon encapsulation suction thrombectomy catheter system with dual balloons and an agitator for localized mechanical thrombolysis, isovolumetric suction, and thrombus fragmentation, designed for minimally invasive removal of large-volume thrombi from the pulmonary artery and iliac veins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If catheter-directed thrombolysis (CDT) is used, then thrombus removal is achieved, but localized thrombolysis is ineffective leading to systemic dispersal
Solution Approach 1:
The patent introduces an intermediary containment mechanism (balloon or sheath) between the thrombus and the bloodstream. This intermediary structure localizes the thrombolytic action and contains the thrombus material, preventing systemic dispersal while maintaining effective thrombus removal through controlled lysis within the confined space.
Solution Approach 2:
The patent applies local quality by creating a localized treatment zone using balloons or sheaths that confine the thrombolytic activity to a specific segment of the vessel. This allows concentrated thrombolysis at the target site while preventing the thrombus material from dispersing systemically through the bloodstream.
2Productivity
If mechanical suction thrombectomy is used, then thrombus removal speed is improved, but risk of venous wall damage increases
Solution Approach 1:
The patent uses a sheath or balloon as an intermediary protective barrier between the mechanical suction device and the venous wall. This intermediary structure allows aggressive thrombus removal through the suction device while the sheath/balloon prevents direct contact and potential damage to the delicate venous endothelium.
Solution Approach 2:
The patent employs beforehand cushioning by deploying a protective sheath or inflated balloon before performing mechanical suction thrombectomy. This pre-established protective barrier cushions and protects the venous wall from the potentially traumatic mechanical forces of rapid thrombus removal.
3Reliability
If aggressive thrombectomy is performed, then thrombus removal completeness is improved, but risk of distal embolization increases
Solution Approach 1:
The patent introduces a containment intermediary (balloon or sheath) that acts as a physical barrier preventing fragmented thrombus material from dislodging and embolizing distally during aggressive thrombectomy. The intermediary maintains containment while allowing complete thrombus removal through controlled manipulation within the confined space.
Solution Approach 2:
The patent applies local quality by creating a localized containment zone that restricts thrombus fragmentation and movement to a confined area. This localized control allows aggressive thrombus removal while preventing fragments from traveling distally through the bloodstream to cause embolization.
4Adaptability or versatility
If standard endovascular devices are used, then treatment is applicable to common DVT, but no tailored solution exists for massive and sub-massive PE
Solution Approach 1:
The patent applies universality by designing a multi-functional catheter system that can adapt to different thrombus sizes and locations. The system combines thrombolytic delivery, mechanical agitation, and suction capabilities in a single platform that can be configured for treating both standard DVT and massive PE through adjustable parameters and components.
Solution Approach 2:
The patent employs dynamics by creating an adaptable system where the treatment approach can be dynamically adjusted based on the specific clinical scenario. The catheter system allows modification of thrombolytic dosage, suction pressure, and mechanical agitation intensity to optimize treatment for varying thrombus burdens from small DVT to massive PE.
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 catheter system achieves at least 90% thrombus removal with reduced risk of VTE and PTS, minimizing surgical time and vessel trauma, and preventing distal embolization.
Implementation Method 1
localized mechanical thrombolysis
Implementation Method 2
agitator operable to agitate the thrombus
Implementation Method 3
suction lumen in fluid communication with the treatment area
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
The disclosure provides for an adjustable catheter system with isovolumetric suction and restoration of fluid for the removal of a thrombus and a method of use thereof. The catheter system includes an inner catheter and an outer sheath surrounding at least a portion of the inner catheter. The inner catheter may include at least three lumina extending from the proximal end to the distal end of the inner catheter, at least one infusion fenestration along the infusion segment, and a distal encapsulation balloon at the distal end. The outer sheath may include at least three lumina extending from the proximal end to the distal end of the outer sheath and a proximal encapsulation balloon at the distal end. The catheter system may further include an agitator for mechanical morcellation of the thrombus.