Thrombectomy Sheath With Sonovisible Element
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Solution Overview
Problem
Current methods for venous thrombectomy are limited, with existing devices causing side effects such as hemoglobinuria and renal failure, and conventional treatments risk bleeding complications, necessitating a need for localized thrombus dissolution or removal without affecting the cardiovascular system.
Innovation Solution
A thrombus removal system comprising an umbrella catheter and a balloon catheter that can be deployed to occlude vessels, introduce chemical agents or disruptive oscillations, and apply suction to disrupt and remove thrombi, while preventing fluid and thrombus fragments from entering the bloodstream.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chemical agents are introduced to dissolve thrombus, then thrombus dissolution is achieved, but bleeding complications occur due to systemic circulation of chemicals
Solution Approach 1:
The patent applies local quality by delivering chemical agents directly to the thrombus site through a catheter system with localized delivery mechanisms. The system introduces chemical agents (such as tissue plasminogen activators or plasmin) specifically at the thrombus location rather than systemically, thereby achieving thrombus dissolution while minimizing bleeding complications through localized action only where needed
2Reliability
If conventional thrombectomy devices are used, then thrombus removal is achieved, but side effects such as hemoglobinuria and renal failure occur
Solution Approach 1:
The patent applies the extraction principle by removing the harmful pulverization step from conventional thrombectomy devices. Instead of using high-power ultrasound to pulverize thrombus (which causes hemoglobinuria and renal failure), the system extracts only the necessary function of thrombus disruption through gentle mechanical means or chemical dissolution, then removes the thrombus intact through suction, thereby achieving thrombus removal without generating harmful fragments that cause hemoglobinuria and renal failure
Solution Approach 2:
The patent introduces chemical agents as intermediaries to facilitate thrombus dissolution. These chemical agents (such as tissue plasminogen activators or plasmin) act as mediators between the delivery system and the thrombus, enabling thrombus breakdown through biochemical pathways rather than mechanical pulverization, thereby avoiding the harmful side effects of conventional mechanical thrombectomy devices
3Ease of operation
If small catheter size is used, then device flexibility is improved, but usefulness in extensive thrombosis is limited
Solution Approach 1:
The patent applies the nested doll principle by designing a catheter system where components are nested within each other: the guidewire is inserted first, then the catheter is advanced over the guidewire, and the occlusion balloon is deployed within the catheter. This nested configuration allows the system to maintain a compact, flexible profile during insertion while enabling deployment of larger functional elements (such as the occlusion balloon and chemical delivery mechanisms) at the target site, thereby achieving both device flexibility and adaptability for extensive thrombosis
4Reliability
If saline injection is used to pulverize clot, then thrombus disruption is achieved, but fluid overload occurs
Solution Approach 1:
The patent applies mechanics substitution by replacing the mechanical pulverization method (high-power ultrasound) with chemical dissolution mechanisms. Chemical agents such as tissue plasminogen activators or plasmin are delivered to the thrombus to dissolve it through biochemical pathways, eliminating the need for large volumes of saline injection and subsequent fluid overload, while still achieving effective thrombus disruption
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 system effectively disrupts and removes thrombi while minimizing systemic effects, reducing the risk of bleeding complications and fluid overload, thereby improving patient safety and treatment efficacy.
Implementation Method 1
the balloon capable of inflation within a lumen of a mammalian vessel to substantially or completely occlude the lumen of the mammalian vessel
Implementation Method 2
the one or more chemical agents are selected from the group consisting of a tissue plasminogen activator, plasmin and thrombin
Implementation Method 3
a suction source in communication with a second balloon catheter lumen defined within the balloon catheter tube, the suction source capable of removing fluid and/or a particulate from the lumen of the mammalian vessel during operation of the suction source
Data Source
AI summary
Thrombectomy systems and devices and methods of using the same. In an exemplary embodiment of a thrombectomy system of the present disclosure, the thrombectomy system comprises a thrombectomy sheath, comprising a circumferential outer wall reinforced with a reinforcement, configured as an elongated tube having a lumen therethrough; and a sonovisible element positioned at or near a distal end of the circumferential outer wall; wherein the thrombectomy sheath is sized and shaped to be at least partially positioned within a vein proximal to a thrombus or other item within the vein and further configured to expand to contact the vein to secure the thrombectomy sheath within the vein; and wherein the lumen is sized and shaped to receive a device selected from the group consisting of a balloon catheter and a snare having a loop.