SYSTEMS AND METHODS FOR PEDAL REVASCULARIZATION ASSESSMENT

• US 20140052006A1
• Filed: 08/14/2013
• Published: 02/20/2014
• Est. Priority Date: 08/15/2012
• Status: Active Grant

• Current Assignee: Pedra Technology Pte Ltd.
• Original Assignee: Nanyang Technological University
• Inventors: Lee, Kijoon, Dong, Jing, Bi, Renzhe
• Granted Patent: US 9,636,025 B2
• Time in Patent Office: Days
• US Class Current: 600/479
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/683 Means for maintaining contact with the body A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

Diffuse optical flow (DOF) sensors can be used to assess deep tissue flow. DOF sensors positioned on a foot can provide fluctuating light intensity data to an analyzer, which can then determine absolute and/or relative blood flow. The determined absolute and/or relative blood flow can be signaled to an operator, for example a surgeon for intra-operative use. DOF sensors may be utilized to assess pedal revascularization, for example to guide interventional procedures and to evaluate their efficacy. A support structure can carry a plurality of DOF sensors, such that when the support structure is placed onto a patient'"'"'s foot, the DOF sensors are disposed adjacent different locations on the foot. The different locations may correspond to different topographical regions of the foot, for example different pedal angiosomes.

Claims

1. A system for assessment of peripheral blood flow during peripheral vascular intervention, the system comprising:

a support structure configured to be positioned onto a patient'"'"'s foot;

a diffuse optical flow (DOF) sensor carried by the support structure;

an analyzer configured to analyze data from the DOF sensor to determine absolute and/or relative blood flow at a location near the DOF sensor when the support structure is positioned onto the patient'"'"'s foot; and

a feedback device configured to provide a signal indicative of the absolute and/or relative blood flow determined by the analyzer.

2. The system of claim 1, wherein the support structure comprises a retention ring and an adhesive material.

3. The system of claim 1, wherein the support structure comprises a strap having the DCS sensor attached thereto.

4. The system of claim 1, wherein the support structure comprises surgical tape.

5. The system of claim 1, wherein the DOF sensors are arranged such that when the support structure is positioned onto the patient'"'"'s foot, at least two of the DOF sensors are over different topographical locations in the foot including different pedal angiosomes.

6. The system of claim 5, wherein the DOF sensors are arranged such that when the support structure is positioned over the patient'"'"'s foot, at least five of the DCS sensors are over different topographical locations in the foot including different pedal angiosomes.

7. The system of claim 1, wherein the analyzer comprises a software autocorrelator.

8. The system of claim 1, wherein the analyzer comprises a hardware autocorrelator.

9. The system of claim 1, wherein the signal indicative of the absolute and/or relative blood flow is visual, audible, or tactile.

10. The system of claim 1, wherein the system is configured to provide the signal indicative of the absolute and/or relative blood flow in substantially real-time.

11. The system of claim 10, wherein the system is configured to provide the signal indicative of the absolute and/or relative blood flow within 1 second from measurement.

12. A method for real-time assessment of peripheral blood flow during peripheral vascular intervention procedures, the method comprising:

disposing at least one diffuse optical flow (DOF) sensor adjacent to a location on a foot of a patient;

obtaining measurements of intensity fluctuation from the DOF sensor;

analyzing the obtained measurements to determine an absolute and/or relative blood flow rate at the location; and

signaling the determined absolute and/or relative blood flow rate to an operator.

13. The method of claim 12, wherein disposing the at least one DOF sensor comprises placing a support structure onto the foot of the patient, the DOF sensor being carried by the support structure.

14. The method of claim 12, further comprising disposing a plurality of DOF sensors adjacent to a respective plurality of locations on the foot of the patient.

15. The method of claim 14, wherein the plurality of locations comprises at least two locations corresponding to different topographical locations in the foot including different pedal angiosomes.

16. The method of claim 15, wherein the plurality of locations comprises at least five locations corresponding to five different topographical locations in the foot including different pedal angiosomes.

17. The method of claim 12, wherein the signaling comprises providing visual, audible, or tactile indicia of absolute and/or relative blood flow.

18. The method of claim 12, wherein the signaling the determined absolute and/or relative blood flow rate to an operator is performed in less than 1 second from measurement.

19. A method for assessment of peripheral blood flow during peripheral vascular intervention procedures, the method comprising:

disposing a plurality of diffuse optical flow (DOF) sensors adjacent to a respective plurality of locations on an extremity of a patient, wherein at least two of the locations correspond to different topographical locations in the foot including different pedal angiosomes;

determining an absolute and/or relative blood flow rates at each of the plurality of locations in the extremity of the patient; and

signaling the determined absolute and/or relative blood flow rates to an operator.

20. The method of claim 19, wherein the extremity is a foot.

21. The method of claim 19, wherein the extremity is a hand.

22. The method of claim 19, wherein the signaling is performed in substantially real-time.

23. The method of claim 19, further comprising utilizing the determined absolute and/or relative blood flow rates to assess the efficacy of an interventional procedure.

24. A patient interface, for supporting a plurality of diffuse optical flow (DOF) sensors in optical communication with a patient'"'"'s foot, comprising:

a support, configured to be mountable on and carried by the foot;

at least three DOF sensors carried by the support, each sensor corresponding to a separate topographical location in the foot including an angiosome selected from the group consisting of;

the angiosome of the medial plantar artery;

the angiosome of the lateral plantar artery;

the angiosome of the calcaneal branch of the posterior tibial artery;

the angiosome of the calcaneal branch of the peroneal artery; and

the angiosome of the dorsalis pedis artery.

25. A patient interface as in claim 24, comprising at least four sensors carried by the support, each sensor corresponding to a separate topographical location in the foot including an angiosome selected from the group consisting of:

the angiosome of the medial plantar artery;

the angiosome of the lateral plantar artery;

the angiosome of the calcaneal branch of the posterior tibial artery;

the angiosome of the calcaneal branch of the peroneal artery; and

the angiosome of the dorsalis pedis artery

26. A patient interface as in claim 24, wherein the support comprises a retention ring and an adhesive material.

27. A patient interface as in claim 24, wherein the support comprises a strap.

28. A patient interface as in claim 24, wherein the support comprises surgical tape.

29. A patient interface as in claim 24, wherein each sensor comprises an optical source fiber and an optical detector fiber.

30. A patient interface as in claim 29, wherein the optical source fiber and optical detector fiber further comprise at least one coupling, for releasably coupling the sensor to an analyzer.

31. A patient interface as in claim 29, comprising a cable, which includes a plurality of pairs of source fibers and detector fibers, each pair connected to a separate sensor.

32. A patient interface as in claim 24, wherein each sensor is releasably carried by the support.