System and method for FFR guidewire recovery
Inventors
Assignees
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Publication Number
US-10080872-B2
Publication Date
2018-09-25
Expiration Date
Abstract
A kit for coronary treatment comprising a pressure sensing guidewire that includes a pressure sensor for measuring pressure within a patient's vasculature. A sheath comprising a tube having a proximal end and a distal end and defining an internal lumen sized for receiving the pressure sensing guidewire; a hemostasis valve positioned over the proximal end of the tube; a cylindrical element attached to the distal end of the tube, the cylindrical element having an internal lumen sized for receiving a conventional guidewire; wherein the pressure sensing guidewire is configured to be slideably insertable into the tube from the proximal end of the tube; and further wherein, the tube is configured to permit the pressure sensing guidewire, including the pressure sensor, to freely slide distally and proximally within the tube at the election of a user.
Core Innovation
The invention relates to recovering and reusing a fractional flow reserve (FFR) pressure sensing guidewire that cannot initially cross a coronary stenosis. The problem addressed is that an FFR guidewire that fails to cross a lesion would be wasted and that decoupling the pressure sensor guidewire from other components is needed to preserve flexibility and pushability through tortuous anatomy.
A kit/system is provided for assessing a lesion in a patient’s vasculature using a pressure sensing guidewire that includes a pressure sensor. The kit includes a sheath with a tube and a hemostasis valve that allows the pressure sensing guidewire to slide freely within the tube when un-clamped, and also includes a distal cylindrical Rx portion sized for a conventional guidewire to be advanced through tortuous anatomy.
Two sheath/tube configurations are described. One configuration uses an open-ended distal tube with distal/proximal markers, and another configuration uses a blind-ended tube with a port for aortic pressure matching and fluid communication between the tube and the Rx lumen. The pressure sensor is positioned for Pd/Pa measurement, then the conventional guidewire and sheath are withdrawn while leaving the recovered FFR guidewire in place for FFR measurement and subsequent therapy.
Claims Coverage
The document includes one independent method claim covering an assessment workflow that uses a pressure sensing guidewire and a tube/hemostasis valve arrangement to reposition the pressure sensor relative to a lesion. The claim contains four main inventive concepts: two-phase guidewire handling, hemostasis-valve tube loading of the pressure sensing guidewire, cylindrical-element advancement over a conventional guidewire, and pressure measurement at a desired location relative to the lesion.
Two-phase pressure sensing guidewire insertion and withdrawal
Withdrawing the pressure sensing guidewire from the patient’s vasculature and later reinserting it for pressure assessment.
Hemostasis valve tube loading of the pressure sensing guidewire
Inserting the pressure sensing guidewire into a proximal end of a tube via a hemostasis valve attached to the tube.
Cylindrical element advancement over a conventional guidewire
Inserting a conventional guidewire into the vasculature until its distal end is located at a desired location in relation to the lesion, inserting the conventional guidewire proximal end into a distal end of a lumen of a cylindrical element attached to the tube, and advancing the cylindrical element distally over the conventional guidewire while carrying the pressure sensing guidewire inside the tube until the pressure sensor reaches a desired location with respect to the lesion.
Pressure measurement with the pressure sensing guidewire
Measuring pressure in the vasculature using the pressure sensor.
Across the single independent claim, lesion assessment is performed by positioning a pressure sensor at a desired location relative to the lesion using a hemostasis valve tube and a cylindrical element advanced over a conventional guidewire, followed by measuring vascular pressure with the pressure sensing guidewire.
Stated Advantages
Decoupling the sensor guidewire from the sheath to preserve flexibility/pushability.
Avoiding wasting an expensive FFR guidewire.
Documented Applications
Assessing a coronary vascular lesion/stenosis by recovering and reusing an FFR pressure sensing guidewire for Pd/Pa measurement and subsequent FFR measurement and therapy.
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