RADIAL ARTERY DEVICE

• US 20150201948A1
• Filed: 08/12/2013
• Published: 07/23/2015
• Est. Priority Date: 08/13/2012
• Status: Active Grant

• Current Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Original Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Inventors: Kornowski, Ran, Vaknin Assa, Hana
• Granted Patent: US 9,943,316 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

According to an aspect of some embodiments of the present invention there is provided a vessel pressure control device configured for selectively applying pressure to a radial artery, the device comprising: a sensor configured to sense one or more parameters associated with blood flow through a portion of the radial artery; a pressure application element adapted to apply variable amounts of pressure to the portion of the radial artery; and a controller configured to apply logic and generate a signal to control the pressure application element in response to the one or more measured parameters, the signal controlling the pressure application element to modify or maintain the applied pressure so that at least some blood flow is maintained through the radial artery portion in an amount sufficient to reduce or prevent radial artery occlusion, and so that the applied pressure is sufficient to prevent bleeding from the portion.

Claims

1. A vessel pressure control device configured for selectively applying pressure to a radial artery, said device comprising:

a sensor configured to sense one or more parameters associated with blood flow through a portion of said radial artery;

a pressure application element adapted to apply variable amounts of pressure to said portion of said radial artery; and

a controller configured to apply logic and generate a signal to control said pressure application element in response to said one or more measured parameters, said signal controlling said pressure application element to modify or maintain said applied pressure so that at least some blood flow is maintained through said radial artery portion in an amount sufficient to reduce or prevent radial artery occlusion, and so that said applied pressure is sufficient to prevent bleeding from said portion.

2. A device according to claim 1, wherein said sensor comprises a Doppler ultrasound sensor positioned and adapted to measure a blood flow rate through said radial artery portion.

3. A device according to claim 1 or claim 2, wherein said sensor is adapted to sense said one or more parameters on a finger.

4. A device according to any one of claims 1-3, further comprising a memory in electrical communication with said controller, said memory storing one or more value thresholds and/or ranges for monitoring said sensed parameter.

5. A device according to any one of claims 1-4, further comprising a memory in electrical communication with said controller, said memory storing data associating said one or more parameters with an applied pressure.

6. A device according to any one of claims 1-5, further comprising a communication element adapted to transmit signals associated with said one or more parameters.

7. A device according to any one of claims 1-6, further comprising a bleeding sensor adapted to detect bleeding from said radial artery portion and send a bleeding signal associated with said bleeding to said controller, said controller adapted to send said signal to said pressure application element to increase said applied pressure in response to said bleeding signal.

8. A device according to any one of claims 1-7, further comprising an output element adapted to provide output associated with said one or more parameters.

9. A device according to any one of claims 1-8, wherein said sensor is positioned within said pressure application element.

10. A device according to any one of claims 1-9, wherein said sensor is adapted to measure a direction of blood flow through said radial artery portion.

11. A device according to any one of claims 1-10, Wherein said pressure application element has a pressure applying surface of about 25 mm² to about 400 mm².

12. A device according to any one of claims 1-11, further comprising a strap sized to fit around a wrist.

13. A device according to any one of claims 1-12, wherein said sensor is adapted to sense said one or more parameters at a depth of no more than about 10 mm.

14. A device adapted for measuring blood flow through a portion of a radial artery, said device comprising:

a sensor adapted to sense one or more parameters associated with an amount of blood flow through said portion, said sensor is adapted to sense said one or more parameters at a depth of no more than about 10 mm; and

an output interface electrically coupled to said sensor, said output interface configured to provide output according to one or more predetermined thresholds and/or ranges of said one or more parameters.

15. The device of claim 14, wherein said sensor comprises a Doppler ultrasound sensor.

16. The device of claim 14 or claim 15, wherein said output is further configured to output a direction of said blood flow.

17. The device of any one of claims 14-16, wherein said sensor comprises a sensing region sized to receive echoes from a portion of said radial artery without sensing other vessels.

18. The device of any one of claims 14-17, wherein said device is sized and shaped to be compatible with other radial artery closure devices.

19. The device of any one of claims 14-18, wherein said output comprises a first output type if said one or more parameters fall within said range and/or said threshold, and a second output type if said one or more parameters do not fall within said range and/or said threshold.

20. The device of any one of claims 14-19, wherein a surface of said device comprises an adhesive on a contact surface thereof for mechanically coupling said device to skin.

21. A method of controlled closure of a portion of a radial artery comprising:

applying pressure to said radial artery portion in an amount to stop bleeding from said radial artery portion; and

maintaining or adjusting said applied pressure, so that enough blood flows through said radial artery portion to prevent or reduce radial artery occlusion, while said stopped bleeding is maintained.

22. A method according to claim 21, further comprising monitoring one or more parameters associated with blood flow through said radial artery portion, and wherein said maintaining or adjusting comprises maintaining or adjusting according to said monitoring.

23. A method according to claim 21 or claim 22, wherein said applying pressure to said radial artery portion comprises applying about 60-100 mmHg to said radial artery portion.

24. A method according to any one of claims 21-23, wherein said applying pressure to said radial artery portion comprises applying pressure so that a rate of blood flow through said radial artery portion is reduced to about 10-40 ml/min.

25. A method according to any one of claims 21-24, wherein said applying comprises applying pressure so that said blood flow is inadequate to oxygenate a hand without collateral blood flow from an ulnar artery.

26. A method according to any one of claims 21-25, wherein said applying comprises applying pressure to said radial artery portion without compressing a radial nerve to cause symptoms.

27. A method according to any one of claims 25-26, further comprising monitoring a direction of said blood flow through said radial artery portion.

28. A method according to any one of claims 21-27, wherein said applying comprises applying pressure to maintain a blood flow of at least 50% of a baseline.

29. A method according to any one of claims 21-28, further comprising monitoring said blood flow proximal to a branch point of said radial artery and/or to an arterial arch.

30. A method according to any one of claims 21-29, wherein said applying comprises applying pressure to prevent transmission of pulses through said radial artery portion.

31. A method according to any one of claims 21-30, wherein said adjusting comprises reducing said applied pressure in response to a vessel spasm.

32. A method according to any one of claims 21-31, wherein said applying comprises applying according to a protocol.

33. A method according to any one of claims 21-32, further comprising monitoring oxygenation of tissues of a hand containing said radial artery portion.

34. A method according to any one of claims 21-33, further comprising performing one or more measurements to obtain calibration data.

35. A method according to claim 34, further comprising comparing said blood flow to said calibration data.

36. A method according to any one of claims 21-35, wherein said applying pressure comprises applying enough pressure so that a cross sectional area of said radial artery portion is reduced by about 50-90%.