Double-Balloon Catheter for Local Thrombolysis and Thrombus Aspiration
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Solution Overview
Problem
Current therapies for acute ischemic stroke, such as intravenous thrombolysis and stent thrombectomy, face challenges including prolonged treatment times and thrombus escape, especially in intracranial vessels, where existing distal end protectors are inadequate.
Innovation Solution
A double-balloon catheter system with a first balloon to block blood flow and a second balloon to deliver thrombolytic drugs through micropores, combined with a Y-type hemostasis valve for negative pressure suction, to facilitate thrombectomy and prevent thrombus escape.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If intravenous thrombolysis is used, then the treatment can be administered systemically, but the treatment time is prolonged and thrombus escape occurs
Solution Approach 1:
The treatment is segmented into two distinct phases: first, local thrombolysis is performed by injecting thrombolytic agents directly into the occluded vessel through the catheter to dissolve the thrombus in situ; second, the dissolved thrombus is mechanically removed using the aspiration function. This segmentation allows for targeted, rapid thrombus dissolution without the need for prolonged systemic infusion, thereby reducing overall treatment time while maintaining ease of administration.
Solution Approach 2:
The catheter is pre-positioned within the occluded vessel before thrombolysis begins, and the thrombolytic agent is delivered directly to the thrombus site immediately upon catheter placement. This preliminary positioning and immediate localized drug delivery eliminate the delay associated with systemic circulation and distribution, significantly reducing treatment time while keeping the procedure straightforward to perform.
2Productivity
If stent thrombectomy or vascular aspiration is performed, then thrombus removal is achieved, but wound sites increase and treatment time window is prolonged
Solution Approach 1:
The device merges multiple functions into a single integrated catheter system: thrombolytic agent delivery, local thrombus dissolution, and mechanical aspiration of dissolved thrombus. By combining these functions in one device, the procedure can be completed in a single step without requiring separate interventions or multiple access points, thereby improving thrombus removal efficiency while minimizing treatment time and reducing the number of wound sites.
3Reliability
If distal end protectors are used in large blood vessels, then protection is provided, but they are inadequate for intracranial vascular stroke in M1 or M2 or distal end cerebral arteries
Solution Approach 1:
The catheter system is designed with universal applicability across different vessel sizes and locations, including large blood vessels and intracranial cerebral arteries (M1, M2, and distal segments). The catheter's flexible design and adjustable aspiration capabilities allow it to function effectively in various anatomical configurations, providing reliable distal end protection whether used in peripheral or intracranial vessels, thereby enhancing both reliability and adaptability.
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 significantly shortens surgical operation time, improves clinical prognosis, and provides distal-end protection, making the procedure safer and more effective.
Implementation Method 1
inject normal saline into a first balloon at a distal end of the double-balloon catheter to expand the first balloon to completely fit an inner wall of a blood vessel so as to block a blood flow at a distal end
Implementation Method 2
a thrombolytic drug is injected into a second balloon, from which the thrombolytic drug is released by means of micropores in the surface of the second balloon to the blood vessel for thrombosis
Implementation Method 3
a negative pressure is applied to a lumen of an access sheath by means of a Y-type hemostasis valve to suck away the dissolved thrombus
Data Source
AI summary
A double-balloon thrombolysis and thrombectomy device, comprising a catheter, an access sheath, and a hemostasis valve. The catheter comprises a base, a body, a first balloon, and a second balloon, the first balloon and the second balloon are sleeved over the body, the first balloon is located at a distal end of the body, and the second balloon is located at the proximal end of the first balloon; the base is connected to the proximal end of the body, and comprises a main connection port, a first connection port and a second connection port; the first balloon is connected to the first connection port, and the second balloon is connected to the second connection port; the surface of the second balloon is provided with a plurality of micropores; and the access sheath is sleeved over the catheter body, and connected to the catheter body through the hemostasis valve.