Dual sensor system for continuous blood pressure monitoring during transcatheter heart valve therapies
Inventors
Glawdel, Tom • GLOVER, Christopher • Caron, Eric • ABEL, Sylvain
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11406271-B2
Publication Date
2022-08-09
Expiration Date
Abstract
Dual sensor system for continuous blood pressure monitoring during transcatheter heart valve therapies (TVT), such as transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR), comprises a controller, a support guidewire for TVT containing a first Fabry-Pérot (FP) optical pressure sensor near its distal end, and a pigtail catheter for delivery of contrast medium containing a second FP optical pressure sensor near its distal end. For example, for TAVR, the support guidewire is positioned to place the first optical pressure sensor within the left ventricle (LV) for monitoring LV pressure, the pigtail catheter is positioned in the aorta to place the second optical pressure sensor in the ascending aorta for direct measurement of pressure in the aorta, downstream of the aortic valve, enabling continuous monitoring of blood pressure at both sensor locations during TAVR. The controller may be configured to interface with standard patient monitoring systems.
Core Innovation
The disclosed invention provides a dual sensor system for monitoring blood pressure at first and second locations within a heart and blood vessels of a patient during transcatheter valve therapy (TVT). The system uses a controller and first and second Fabry-Pérot (FP) optical pressure sensors positioned at different anatomical locations, and the controller couples to optical input/output connectors of a sensor support guidewire and a sensor angiographic catheter to generate data indicative of blood pressure.
The system integrates pressure monitoring with device-compatible structures that provide fluid contact to the FP sensors. In the sensor support guidewire, a tubular member includes a first optical fiber extending to a distal first FP optical pressure sensor located near an atraumatic pre-formed curved flexible distal tip, and a first sensor aperture adjacent the first FP optical pressure sensor for fluid contact. In the sensor angiographic catheter, multi-lumen catheter tubing includes first and second lumens and a pigtail distal tip, and the second FP optical pressure sensor is positioned near the pigtail distal tip with a second sensor aperture for fluid contact.
The controller configuration generates data comprising first and second pressure waveforms and provides interfacing to patient monitoring systems via a communications interface. The disclosed architecture includes an optical control unit having a light source and detector for operating the first and second FP optical pressure sensors and processing optical data from the FP sensors, together with a processor, memory, and hardware and/or software components for generating analog and digital data.
In embodiments for TVT procedures including transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR), the system specifies placement of the first and second FP optical pressure sensors at locations used to determine hemodynamic parameters and transvalvular blood pressure gradients. The disclosed catheter further includes a second port comprising an injection port and a second lumen comprising a plurality of apertures for fluid ejection along a distal region between the second sensor aperture and the pigtail distal tip.
Claims Coverage
The document contains four independent claims. Across these claims, the coverage is built around four inventive aspects: a dual sensor controller-driven system using optical FP pressure sensing, a sensor support guidewire construction with distal FP sensing and fluid apertures, a sensor angiographic catheter construction with distal FP sensing and dual-lumen injection/aperture functionality, and a kit combining the guidewire and catheter with optical connector and FP sensor pairing.
Dual sensor system for TVT blood pressure monitoring with paired FP optical pressure sensors
A dual sensor system for monitoring blood pressure at first and second locations within a heart and blood vessels during TVT, comprising a controller; a sensor support guidewire with a tubular member, an atraumatic pre-formed curved flexible distal tip, a first optical fiber extending to a first FP optical pressure sensor near the distal tip, and a first sensor aperture adjacent the first FP optical pressure sensor for fluid contact; a sensor angiographic catheter with multi-lumen catheter tubing and a preformed pigtail distal tip, first and second lumens with a second optical fiber extending to a second FP optical pressure sensor near the pigtail distal tip, a second sensor aperture near the second FP optical pressure sensor for fluid contact, and a second port with an injection port and a second lumen with a plurality of apertures for fluid ejection along the distal region; and the controller including an optical control unit with optical input/output ports, a light source and detector for operating the first and second FP optical pressure sensors and processing optical data to generate data indicative of blood pressure, generating first and second pressure waveforms as analog and digital data, and a communications interface for interfacing with a patient monitoring system and peripherals.
Optically coupled sensor support guidewire with distal FP optical pressure sensor and fluid aperture
A sensor support guidewire for dual-sensor TVT blood pressure monitoring comprising a tubular member with a proximal end and a distal end including a flexible distal tip with a pre-formed curved tip; the tubular member including an outer tubular member and an inner tubular member with the inner tubular member inserted within the outer tubular member; an optical fiber extending within the inner tubular member from an optical input/output connector at the proximal end to a first FP optical pressure sensor positioned within a distal region near the flexible distal tip; and a first sensor aperture in the tubular member adjacent the first FP optical pressure sensor for fluid contact.
Optically coupled sensor angiographic catheter with distal FP optical pressure sensor, fluid contact aperture, and injection apertures
A sensor angiographic catheter for dual-sensor TVT blood pressure monitoring comprising multi-lumen catheter tubing with a proximal end and a distal end including a preformed pigtail distal tip; the catheter tubing having a first lumen and a second lumen; a connection hub at the proximal end with a first port for the first lumen and a second port for the second lumen; an optical fiber extending within the first lumen from an optical/input output connector of the first port to a second FP optical pressure sensor positioned within a distal region of the first lumen near the distal tip; a sensor aperture near the second FP optical pressure sensor for fluid contact; and the second port comprising an injection port with the second lumen comprising a plurality of apertures for fluid ejection along a distal region near the pigtail distal tip between the sensor aperture and the distal tip.
Kit for paired FP optical pressure sensing in TVT guidewire and angiographic catheter
A kit comprising components for use with a dual sensor system during TVT, including a first component comprising a sensor support guidewire with a tubular member having a distal flexible atraumatic pre-formed curved distal tip, a first optical fiber extending within the guidewire to a first FP optical pressure sensor near the distal tip, and a first sensor aperture adjacent the first FP optical pressure sensor; and a second component comprising a sensor angiographic catheter with multi-lumen catheter tubing having a distal preformed pigtail distal tip, a first lumen and a second lumen, a connection hub with first and second ports, a second optical fiber extending within the first lumen to a second FP optical pressure sensor near the pigtail distal tip, a second sensor aperture for fluid contact, and the second port having an injection port and the second lumen comprising a plurality of fluid apertures along a distal region between the second sensor aperture and the pigtail distal tip; wherein the first and second FP optical pressure sensors are a pair of FP optical pressure sensors.
Taken together, the independent claims provide coverage of a paired-FP optical pressure sensing arrangement for TVT, including a dual sensor controller system generating blood-pressure data and pressure waveforms, an optical sensor support guidewire with a distal FP sensor and fluid contact aperture, an angiographic catheter with a distal FP sensor and a sensor aperture for fluid contact plus injection/ejection apertures in a second lumen, and a kit that packages the guidewire and catheter as components for use as the dual sensor system.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?