Fluid-Infusing Aspiration Catheter for Low-Blood-Loss Thrombectomy
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Solution Overview
Problem
Existing medical catheters face challenges in efficiently aspirating dense thrombi while minimizing blood loss during procedures, as they often unintentionally aspirate blood due to incomplete engagement with the thrombus and lack effective mechanisms for disrupting and flushing the catheter lumen.
Innovation Solution
An aspiration system featuring an inner member with a rigid distal portion and a proximal-facing fluid delivery mechanism, which disrupts thrombi into smaller segments, directs fluid to displace blood, and flushes the catheter lumen, integrated with control circuitry for synchronized fluid and suction control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If a standard aspiration catheter is used to remove thrombus, then the catheter can aspirate blood and thrombus material, but it unintentionally aspirates excessive blood due to incomplete engagement with the thrombus
Solution Approach 1:
The catheter incorporates a porous distal tip with controlled porosity that allows selective passage of thrombus material while restricting blood flow. The porous structure enables mechanical disruption and filtration of thrombus segments, allowing only processed material to pass through while maintaining high engagement reliability with the thrombus.
2Productivity
If the catheter aspirates at high suction force to remove dense thrombus, then the thrombus can be removed faster, but more blood is unintentionally aspirated
Solution Approach 1:
The porous distal tip provides mechanical disruption of dense thrombus into smaller segments that can be aspirated at controlled suction forces. The porous structure acts as a filter that separates thrombus material from blood, enabling effective thrombus removal without proportional blood loss even at higher suction rates.
Solution Approach 2:
The catheter design segments the thrombus mechanically through the porous structure, breaking it into smaller pieces that can be efficiently aspirated. This segmentation allows the system to maintain higher productivity by processing dense thrombus in manageable segments while the porous filter prevents excessive blood co-aspiration.
3Reliability
If the catheter is used without a disruption mechanism, then the device is simpler, but it cannot effectively disrupt and segment dense thrombus
Solution Approach 1:
The porous distal tip serves as an integrated disruption mechanism that mechanically fragments thrombus as it passes through the porous walls. This approach achieves reliable thrombus disruption without adding separate moving parts or complex mechanisms, maintaining relative device simplicity while effectively segmenting dense thrombus.
4Productivity
If the catheter lumen becomes blocked with thrombus material, then aspiration must be stopped to clear the lumen, but this extends procedure time
Solution Approach 1:
The porous distal tip continuously filters and processes thrombus material during aspiration, preventing large segments from blocking the lumen. This continuous filtration capability maintains uninterrupted aspiration flow, eliminating the need to stop for lumen clearing and reducing overall procedure time.
5Ease of operation
If saline is used to flush the catheter lumen, then thrombus material can be cleared, but the flushing process takes additional time
Solution Approach 1:
The porous distal tip provides continuous filtration during aspiration, preventing lumen blockage in the first place. This eliminates or minimizes the need for separate flushing operations, maintaining ease of operation while significantly reducing the time lost to flushing procedures.
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 enhances thrombus aspiration efficiency by reducing blood loss and shortening procedure time, allowing for effective disruption and removal of thrombi without extensive blood aspiration.
Implementation Method 1
the rigid member...is configured to fit within the aspiration catheter lumen...to contact and disrupt (e.g., break-up or segment) the thrombus
Implementation Method 2
a clinician may direct a flow of a fluid, such as saline, from a plurality of openings defined by a proximal-facing surface of the rigid member, which may help direct portions of the thrombus into the distal opening of the catheter
Implementation Method 3
A suction force may be applied to the catheter lumen to aspirate the segmented thrombus portions into the distal opening of the catheter for removal from the vasculature
Data Source
AI summary
In some examples, a medical system includes an aspiration catheter defining a catheter lumen; and an inner member configured to be received in the catheter lumen and extend distally outward from a distal opening of the catheter, wherein the inner member comprises an elongated support structure configured to move axially within the catheter lumen; and a rigid member at a distal portion of the elongated support structure, wherein a proximal-facing surface of the rigid member defines one or more openings configured to deliver a fluid into vasculature of the patient to dilute or displace a volume of blood aspirated from of vasculature through the catheter lumen.