APPARATUS AND METHOD FOR INTRAVASCULAR MEASUREMENTS

• US 20150005648A1
• Filed: 07/01/2014
• Published: 01/01/2015
• Est. Priority Date: 07/01/2013
• Status: Active Grant

• Current Assignee: Zurich Medical Corporation (Shandong Weigao Group Medical Polymer Company Limited)
• Original Assignee: Zurich Medical Corporation (Shandong Weigao Group Medical Polymer Company Limited)
• Inventors: Donadio, James V. III, Sham, Kin-Joe, Chan, Charles C.H., McSherry, Paul Michael, Gam, Paul J.
• Granted Patent: US 10,702,170 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/0204 of power management
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

Intravascular diagnosis apparatus and methods are disclosed. In one aspect of the disclosed technology, a intravascular diagnosis apparatus includes a monitoring guidewire and a display unit. The monitoring guidewire includes a core wire and a sensor disposed in a distal region of the core wire. The display unit includes a processor and a display screen, and is capable of receiving communication from the monitoring guidewire. The display unit is configured to perform computations using the processor based on communications received from the monitoring guidewire and is configured to display information on the display screen based on the computations. The display unit can be configured to be disposed after a predetermined number of uses or after a predetermined duration of use.

Claims

1. A portable apparatus for intravascular diagnosis, the portable apparatus comprising:

a monitoring guidewire comprising a core wire and a sensor disposed in a distal region of the core wire;

a display unit configured to be disposed after a predetermined number of uses or after a predetermined duration of use, the display unit comprising a processor and a display screen, wherein the display unit is capable of receiving communication from the monitoring guidewire, is configured to perform computations using the processor based on communications received from the monitoring guidewire, and is configured to display information on the display screen based on the computations.

2. The portable apparatus of claim 1, the display unit further comprising one or more batteries configured to power the display unit for a predetermined duration of use, the display unit configured to be disposed after the one or more batteries are depleted.

3. The portable apparatus of claim 2, wherein the one or more batteries are non-rechargeable.

4. The portable apparatus of claim 1, wherein the display unit is configured to be inoperable after a predetermined number of uses greater than one.

5. The portable apparatus of claim 1, the display unit further comprising one or more batteries configured to power the display unit.

6. The portable apparatus of claim 1, wherein the one or more batteries are rechargeable by at least one of:

a power source of the display unit, and a power source external to the display unit.

7. The portable apparatus of claim 4, wherein the monitoring guidewire is configured to be disposed after a single use.

8. The portable apparatus of claim 1, wherein the display unit is configured to be inoperable after a single use.

9. The portable apparatus of claim 1, wherein the display unit and the monitoring guidewire communicate wirelessly.

10. The portable apparatus of claim 1, wherein the display unit further comprises a connector configured to establish a communicative connection with the monitoring guidewire.

11. The portable apparatus of claim 10, wherein the connector is further configured to establish a mechanical connection with the monitoring guidewire to control the guidewire within a vasculature.

12. The portable apparatus of claim 1, further comprising a torquer configured to engage the monitoring guidewire to control the guidewire within a vasculature.

13. The portable apparatus of claim 1, wherein the monitoring guidewire further comprises a housing surrounding the sensor, the housing being laser etched to provide flexibility for the housing.

14. The portable apparatus of claim 1, wherein the monitoring guidewire further comprises a flexible coil surrounding the sensor, the coil having a relaxed portion over the sensor.

15. The portable apparatus of claim 1, wherein the sensor is a pressure sensor and communication from the monitoring guidewire includes measurements from the pressure sensor, and wherein the processor is capable of computing fractional flow reserve based on pressure measurements from only the pressure sensor disposed in the distal region of the core wire.

16. The portable apparatus of claim 15, wherein a push-forward fraction flow reserve is computed as

FFR=(P_sensor−

P_ra)/(P_saved−

P_ra)

wherein;

P_saved are moving means over time of recorded pressure measurements proximal to a first stenosis,

P_sensor are moving means over time of real time pressure measurements distal to the first stenosis, and

P_ra is a constant.

17. The portable apparatus of claim 16, wherein P_sensor are moving means over time of real time pressure measurements distal to the first stenosis and proximal to a second stenosis.

18. The portable apparatus of claim 16, wherein:

P_saved are moving means over time of recorded pressure measurements proximal to the first stenosis and proximal to a second stenosis, and

P_sensor are moving means over time of real time pressure measurements distal to the first stenosis and distal to the second stenosis.

19. The portable apparatus of claim 15, wherein a pull-back fraction flow reserve is computed as

FFR=(P_saved−

P_ra)/(P_sensor−

P_ra)

wherein;

P_saved are moving means over time of recorded pressure measurements distal to a first stenosis,

P_sensor are moving means over time of real time pressure measurements proximal to the first stenosis, and

P_ra is a constant.

20. The portable apparatus of claim 19, wherein P_sensor are moving means over time of real time pressure measurements proximal to the first stenosis and distal to a second stenosis.

21. The portable apparatus of claim 19, wherein:

P_saved are moving means over time of recorded pressure measurements distal to the first stenosis and distal to a second stenosis, and

P_sensor are moving means over time of real time pressure measurements proximal to the first stenosis and proximal to the second stenosis.

22. The portable apparatus of claim 15, wherein the display unit displays on the display screen the fractional flow reserve.

23. The portable apparatus of claim 15, wherein the display unit displays a graph of the pressure measurements.

24. The portable apparatus of claim 1, the display unit further comprising a communications port configured to receive communications that include pressure measurements.

25. The portable apparatus of claim 24, wherein the processor is configured to compute a simultaneous fractional flow reserve as

FFR=(P_sensor−

P_ra)/(P_port−

P_ra)

wherein;

P_port are moving means over time of real-time pressure measurements received at the communications port,

P_sensor are moving means over time of real-time pressure measurements from the pressure sensor disposed in the distal region of the core wire, and

P_ra is a constant.

26. The portable apparatus of claim 24, wherein the display unit is configured with capability to compute fractional flow reserve in at least two ways comprising:

computing fractional flow reserve based on pressure measurements from only the pressure sensor disposed in the distal region of the core wire, and computing fractional flow reserve based on the pressure measurements from the pressure sensor and based on pressure measurements received at the communications port.

27. The portable apparatus of claim 26, the display unit being configured to automatically use one of the at least two ways of computing fractional flow reserve.

28. The portable apparatus of claim 26, the display unit being configured to automatically select one of the at least two ways of computing fractional flow reserve when a condition is present and to automatically select another of the at least two ways of computing fractional flow reserve when the condition is absent.

29. The portable apparatus of claim 26, the display unit being configured to permit a user to manually select one of the at least two ways of computing fraction flow reserve.

30. A portable apparatus for intravascular diagnosis, the portable apparatus comprising:

a monitoring guidewire comprising a core wire and a sensor disposed in a distal region of the core wire;

a handheld display unit configured to be disposed after a predetermined number of uses or after a predetermined duration of use, the handheld display unit comprising a processor and a display screen, wherein the handheld display unit is capable of receiving communication from the monitoring guidewire, is configured to perform computations using the processor based on communications received from the monitoring guidewire, and is configured to display information on the display screen based on the computations.

31. An portable apparatus for intravascular diagnosis, the portable apparatus comprising:

a monitoring guidewire comprising a core wire and a sensor disposed in a distal region of the core wire;

a display unit capable of receiving communication from the monitoring guidewire, the display unit comprising a processor and display screen, the display unit having no capability of being turned off after the display screen is turned on,

wherein the display unit is configured to perform computations using the processor based on communications received from the monitoring guidewire and is configured to display information on the display screen based on the computations.