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Publication Number
US-11771445-B2
Publication Date
2023-10-03
Expiration Date
Abstract
A system for removal of blood or thrombus includes an aspiration catheter having an elongate shaft including an aspiration lumen having proximal end configured to couple to a vacuum source, and a distal end having an orifice, an elongate member configured for placement through the aspiration lumen and having a distal portion including a disruption element configured to disrupt thrombus within the aspiration lumen, and a monitoring device configured for removable connection in between the aspiration catheter and the vacuum source, and including a housing, a pressure sensor in fluid communication with an interior of the housing, a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure, and a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold.
Core Innovation
The invention relates to systems for removal of blood or thrombus that include an aspiration catheter coupled to a vacuum source and an in-line, removable monitoring device. The aspiration catheter includes an aspiration lumen with an orifice at a distal end, configured for placement within a blood vessel.
The elongate member is inserted through the aspiration lumen such that a distal disruptor disrupts thrombus within the aspiration lumen. The monitoring device is configured for real time monitoring of catheter aspiration by measuring fluid pressure via a pressure sensor in fluid communication with an interior housing.
The communication device generates an alert signal when a change in the fluid pressure measured by the measurement device causes the passing of a pre-set threshold. The monitoring device enables detection of vacuum application or lack of vacuum, clogging or stuck condition, system leak or breach or puncture, and thrombus encountered or actively aspirated status.
The description includes real-time monitoring embodiments such as a self-contained in-line pressure transducer and configurations involving an external console and wireless communication, including alert modalities such as LED visual alerts, vibration tactile alerts, and audible sound alerts.
Claims Coverage
The patent includes one independent claim that covers, in combination, an aspiration catheter with a vacuum source, an elongate disruptor member inserted through an aspiration lumen, and a monitoring device for real time pressure-based aspiration monitoring with pre-set threshold alerting. The dependent claims refine primarily the monitoring and alert logic, along with disruptor geometry and actuation aspects.
Blood or thrombus aspiration with vacuum-coupled catheter and aspiration-lumen orifice
An aspiration catheter having an elongate shaft with a distal end configured for placement within a blood vessel, an aspiration lumen coupled to a vacuum source at a proximal end, and an orifice at the distal end of the aspiration lumen.
Elongate disruptor member inserted through the aspiration lumen
An elongate member for placement through the aspiration lumen, having a proximal portion extending from the proximal end of the aspiration lumen and a distal portion comprising a disruptor configured to disrupt thrombus within the aspiration lumen, with an elongate portion extending distally from the disruptor so the elongate portion extends into a thrombus within the blood vessel.
In-line real time monitoring device coupled between catheter and vacuum source
A monitoring device coupled between the aspiration catheter and the vacuum source, comprising a housing with an interior, a pressure sensor in fluid communication with the interior, a measurement device coupled to the pressure sensor for measuring fluid pressure, and a communication device generating an alert signal when the measured change in fluid pressure causes passing of a pre-set threshold.
Memory-based pressure deviation comparison for alerting
The monitoring device includes memory so the measurement device compares measured pressure deviations with information stored in the memory.
Pre-set-threshold alert indicating a clogged condition
The monitoring device is configured so that its alert signal indicates a clogged condition.
Pre-set-threshold alert indicating a system leak
The monitoring device is configured so that its alert signal indicates a system leak.
Rotatable disruptor within the aspiration lumen
The elongate member is configured so that the disruptor can be rotated within the aspiration lumen.
Helical or spiral disruptor form
The elongate member is configured so that the disruptor has a helical or spiral form.
Overall, the claim set is centered on combining an aspiration catheter and vacuum source with a thrombus-disrupting elongate member inserted through the aspiration lumen, together with an in-line removable monitoring device that uses a pressure sensor and a pre-set threshold to generate alert signals. Dependent claims further narrow the monitoring by memory-based interpretation and specific alert conditions, and narrow the disruptor design and actuation.
Stated Advantages
Enables real time monitoring of catheter aspiration by measuring fluid pressure.
Generates alert signals when measured pressure changes pass a pre-set threshold.
Supports detection of vacuum loss or lack of vacuum, clogging or stuck condition, system leaks, and thrombus aspiration status.
Documented Applications
Systems for removal of blood or thrombus using an aspiration catheter with vacuum and an elongate disruptor member inserted through an aspiration lumen.
Use in real-time aspiration monitoring with alert modalities using an in-line pressure sensor and communication device for conditions including vacuum loss, clogging, and system leak.
Integration with rotating or separation disruptor elements and multi-purpose catheters with aspiration combined with infusion or injection port and cooled infusate for reperfusion injury.
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