System for automated measurement of skin perfusion pressure

• US 7,736,311 B2
• Filed: 08/29/2006
• Issued: 06/15/2010
• Est. Priority Date: 09/10/2004
• Status: Expired due to Fees

• Current Assignee: Vasamed, Inc.
• Original Assignee: Vasamed, Inc.
• Inventors: Pierskalla, Irvin T., Bartnik, Daniel J., Reynolds, Brandon W.
• Primary Examiner(s): Nasser; Robert L
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/468,203
• Publication Number:
  US 20060287603A1
• Time in Patent Office: 1,386 Days
• Field of Search: 600/504, 600/507, 600/323, 600/335, 600/334, 600/495, 600/496, 600/363, 600/322, 600453-456, 600/300, 600/386, 600391-392, 128/635, 128/668
• US Class Current: 600/363
• CPC Class Codes: A61B 5/0048 Detecting, measuring or recording by applying mechanical forces or stimuli A61B5/021, A61B5/4884 and A61B9/00 take precedence
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts

Abstract

An automatic skin perfusion measuring system including instrumentation that automatically analyzes perfusion measurements to identify motion artifact and SPP values and a sensor placement device is provided. The instrumentation is configured to ignore motion artifact. Perfusion measurements are designated as SPP values if various criteria are met. SPP value criteria pertain to factors including cuff pressure, perfusion, perfusion change percentages relative to previous and subsequent perfusion measurements, and whether perfusion measurements are increasing or decreasing relative to previous and subsequent perfusion measurements. The sensor placement device assures reliable data is produced when multiple measurements are desired.

Claims

1. An automated skin perfusion pressure measuring device comprising:

an inflatable cuff;

at least one blood flow sensor in communication with the cuff;

at least one pressure sensor in communication with the cuff for reading pressure levels in the cuff;

a pressure instrument in fluid communication with the cuff for inflation and deflation thereof, the pressure instrument comprising;

a source of pressurized air;

a conduit connected to the source of pressurized air and the cuff, thereby placing the source of pressurized air in fluid communication with the cuff;

a microprocessor arranged to receive inputs from the first sensor and the second sensor, the microprocessor capable of controlling pressurized airflow to and from the cuff;

a computer program executable by the microprocessor such that when executed, the computer program causes the microprocessor to;

initiate an automatic inflation sequence resulting in a no flow condition;

initiate an automatic deflation sequence;

automatically qualify a perfusion measurement as an SPP value upon all conditions of a set of predetermined conditions being met during the deflation sequence.

2. The automated skin perfusion pressure measuring device of claim 1 wherein the at least one blood flow sensor is positioned underneath the cuff.

3. The automated skin perfusion pressure measuring device of claim 1 wherein the at least one blood flow sensor is positioned distal to the cuff.

4. The automated skin perfusion pressure measuring device of claim 1 wherein the at least one blood flow sensor is positioned inside a bladder within the cuff.

5. The automated skin perfusion pressure measuring device of claim 1 wherein the at least one blood flow sensor is selected from the group consisting of optical probe means, pulse oximeter means;

optical plethemography means;

motion detecting means; and

laser Doppler means.

6. The automated skin perfusion pressure measuring device of claim 5 wherein the optical probe means comprises a laser transmitter fiber and a receiver photodiode.

7. The automated skin perfusion pressure measuring device of claim 5 wherein the optical probe means comprises a laser transmitter.

8. The automated skin perfusion pressure measuring device of claim 7 wherein the optical probe means further comprises a receiver photodiode.

9. The automated skin perfusion pressure measuring device of claim 5 wherein the optical probe means is connected to the pressure instrument via a fiber optic cable.

10. The automated skin perfusion pressure measuring device of claim 1 wherein one of said predetermined set of conditions comprise the perfusion measurement being from 1 mmHg to approximately 150 mmHg.

11. The automated skin perfusion pressure measuring device of claim 10 wherein if said perfusion measurement is less than 0.20% and said cuff pressure is less than 100 mmHg, then one of said predetermined set of conditions comprise a perfusion increase of from 10% to 50% from a previous perfusion measurement.

12. The automated skin perfusion pressure measuring device of claim 10 wherein if said perfusion measurement is greater than 0.02% and said cuff pressure is greater than or equal to 100 mmHg, then one of said predetermined set of conditions comprise a perfusion increase of from about 20% to about 80%.

13. The automated skin perfusion pressure measuring device of claim 10 wherein if said perfusion measurement is from 0.15% to about 0.20% and said cuff pressure is from 1 mmHg to about 150 mmHg, then one of said predetermined set of conditions comprise a perfusion increase of from about 25% to about 100%.

14. The automated skin perfusion pressure measuring device of claim 10 wherein if said perfusion measurement is less than 0.15% and said cuff pressure is from about 1 mmHg to about 150 mmHg, then one of said predetermined set of conditions comprise a perfusion increase of from about 50% to about 200%.

15. The automated skin perfusion pressure measuring device of claim 1 wherein one condition of the set of predetermined conditions comprises the perfusion measurement being from about 0.05% to about 0.2%.

16. The automated skin perfusion pressure measuring device of claim 1 wherein one of said predetermined set of conditions comprise whether steps following the perfusion measurement being tested for as an SPP value are decreasing.

17. The automated skin perfusion pressure measuring device of claim 16 wherein if the cuff pressure is less than 15 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is one.

18. The automated skin perfusion pressure measuring device of claim 16 wherein if the cuff pressure is in a range from 15 to less than 50 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is two.

19. The automated skin perfusion pressure measuring device of claim 16 wherein if the cuff pressure is in a range from 50 mmHg to less than 100 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is three.

20. The automated skin perfusion pressure measuring device of claim 16 wherein if the cuff pressure is greater than 100 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is five.

21. The automated skin perfusion pressure measuring device of claim 1 wherein one of said predetermined set of conditions comprise whether steps following the perfusion measurement being tested for as an SPP value are increasing.

22. The automated skin perfusion pressure measuring device of claim 21 wherein if the cuff pressure is less than 15 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is one.

23. The automated skin perfusion pressure measuring device of claim 21 wherein if the cuff pressure is in a range from 15 to less than 50 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is two.

24. The automated skin perfusion pressure measuring device of claim 21 wherein if the cuff pressure is in a range from 50 mmHg to less than 100 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is three.

25. The automated skin perfusion pressure measuring device of claim 21 wherein if the cuff pressure is greater than 100 mmHg, the number of steps analyzed following the perfusion measurement being tested for as an SPP value is five.

26. The automated skin perfusion pressure measuring device of claim 1 further comprising a display monitor operably connected to the pressure instrument and capable of displaying data.

27. The automated skin perfusion pressure measuring device of claim 26 wherein the display monitor is capable of displaying data pertaining to microcirculation within an observation volume of tissue.

28. The automated skin perfusion pressure measuring device of claim 26 wherein the display monitor is further capable of displaying data pertaining to cuff pressure.

29. The automated skin perfusion pressure measuring device of claim 28 wherein the display monitor is further capable of graphically displaying cuff pressure versus microcirculation within an observation volume of tissue.

30. The automated skin perfusion pressure measuring device of claim 1 wherein the cuff comprises a transparent window useable to observe the perfusion sensor.

31. The automated skin perfusion pressure measuring device of claim 1 further comprising a placement device for securing the at least one blood flow sensor in place during one or a plurality of measurements.

32. The placement device of claim 31 wherein the device is disposable.

33. The placement device of claim 31 further comprising a detachable sheath configured to secure said at least one blood flow sensor to a patient.

34. The placement device of claim 33 further comprising at least two wings positioned on opposing sides of a proximal end of said sheath;

and receiving openings positioned on opposing side of a distal end of said sheath.

35. The sensor placement device of claim 34 wherein said wings include at least one position indicator therein.

36. The sensor placement device of claim 33 further comprising a measuring guide extending along at least one longitudinal side of said sheath.

37. The sensor placement device of claim 33 further comprising perforated sections, wherein a first perforated section is adjacent said distal end of said sheath, and further wherein a second perforated section is between said first perforated section and a third perforated section positioned nearer to said proximal end of said sheath.

38. The sensor placement device of claim 33 further comprising a cable clamp adjacent said distal end of said sheath and configured to be removed from said sensor placement device and positioned over a cable extending between said probe and a monitoring system.

39. The sensor placement device of claim 33 wherein said sheath includes an adhesive coating on a surface of sheath that is configured to secure said sensor placement device on a patient'"'"'s tissue.

40. The blood flow measuring means placement device of claim 31 wherein said a placement device includes a self-adhesive fabric including a window thereon for inserting said blood flow measuring means.

41. A method of measuring skin perfusion pressure in a patient comprising:

providing an inflatable cuff in communication with at least one blood flow sensor;

initiating an automatic inflation sequence resulting in a no flow condition;

initiating an automatic deflation sequence; and

providing a microprocessor to automatically qualify a perfusion measurement as an SPP value upon all conditions of a predetermined set of conditions being met during the deflation sequence, wherein said predetermined set of conditions comprise (i) determining whether said perfusion measurement is within a range of from approximately 1 mmHg to approximately 150 mmHg;

determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value;

determining whether said perfusion measurement is from between 0.05% to 0.2%; and

determining whether next steps following said perfusion measurement are not decreasing.

42. The method of claim 41 wherein initiating an automatic inflation sequence

comprises:

inflating the cuff to a first pressure;

verifying the blood flow sensor is detecting and measuring perfusion;

inflating the cuff to a second pressure;

verifying a no flow condition is achieved, otherwise;

increasing cuff pressure in predetermined increments until a no flow condition is achieved;

aborting the inflation sequence if the cuff pressure attains a predetermined maximum value before a no flow condition is achieved.

43. The method of claim 42 wherein inflating the cuff to a first pressure comprises inflating the cuff to 5 mmHg to 10 mmHg.

44. The method of claim 42 wherein inflating the cuff to a second pressure comprises inflating the cuff to approximately the patient'"'"'s systolic pressure.

45. The method of claim 42 wherein increasing the cuff pressure in predetermined increments until a no flow condition is achieved comprises increasing the cuff pressure in predetermined increments of approximately 40 mmHg until a no flow condition is achieved.

46. The method of claim 41 wherein providing a microprocessor to automatically qualifying a perfusion measurement as an SPP value upon all conditions of a predetermined set of conditions being met during the deflation sequence further comprises identifying that the measured skin perfusion pressure is not the result of motion artifact.

47. The method of claim 41 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether the perfusion increase is from 10% to 50% when the perfusion measurement is greater than 0.20% and the cuff pressure is less than 100 mmHg.

48. The method of claim 41 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether the perfusion increase is from 20% to 80% when the perfusion measurement is greater than 0.20% and the cuff pressure is greater than or equal to 100 mmHg.

49. The method of claim 41 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether the perfusion increase is from 25% to 100% when the perfusion measurement is from 0.15% to 0.20% and the cuff pressure is any valid cuff pressure.

50. The method of claim 41 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether the perfusion increase is from 50% to 200% when the perfusion measurement is less than 0.15% and the cuff pressure is any valid cuff pressure.

51. The method of claim 41 wherein analyzing a number of subsequent perfusion measurements to determine whether the subsequent perfusion measurements are increasing or decreasing comprises analyzing one subsequent perfusion measurement if the cuff pressure is from 0 to 20 mmHg.

52. The method of claim 41 wherein analyzing a number of subsequent perfusion measurements to determine whether the subsequent perfusion measurements are increasing or decreasing comprises analyzing two subsequent perfusion measurements if the cuff pressure is from 10 to 50 mmHg.

53. The method of claim 41 wherein analyzing a number of subsequent perfusion measurements to determine whether the subsequent perfusion measurements are increasing or decreasing comprises analyzing three subsequent perfusion measurements if the cuff pressure is from 40 to 120 mmHg.

54. The method of claim 41 wherein analyzing a number of subsequent perfusion measurements to determine whether the subsequent perfusion measurements are increasing or decreasing comprises analyzing five subsequent perfusion measurements if the cuff pressure is from 80 mmHg to 150 mmHg.

55. The method of claim 41 wherein automatically qualifying a perfusion measurement as an SPP value upon all conditions of a predetermined set of conditions being met during the deflation sequence further comprises a condition selected from the group consisting of (i) when the cuff pressure is less than 15 mmHg and one subsequent perfusion measurement is increasing;

(ii) when cuff pressure is from 15 to 20 mmHg and two subsequent perfusion measurements are increasing;

(iii) when cuff pressure is from 50 to 100 mmHg and three subsequent perfusion measurements are increasing;

(iv) when cuff pressure is 100 mmHg to 150 mmHg and five subsequent perfusion measurements are increasing.

56. A device for measuring skin perfusion pressure in a patient comprising:

an inflatable cuff with perfusion sensing means for sensing perfusion in communication with said cuff;

means for automatically inflating the cuff, according to an automatic inflation sequence, to a pressure resulting in a no flow condition;

means for automatically deflating the cuff according to an automatic deflation sequence;

means for continuously testing a series of perfusion measurements against a set of predetermined criteria to reject motion artifact and automatically qualify one of said perfusion measurements as an SPP value upon all conditions of the predetermined set of criteria being met.

57. The device of claim 56 wherein the automatic inflation sequence comprises:

inflating the cuff to a first pressure;

verifying the perfusion sensing means is detecting and measuring perfusion;

inflating the cuff to a second pressure;

verifying a no flow condition is achieved;

increasing cuff pressure in predetermined increments until a no flow condition is achieved;

aborting the inflation sequence if the cuff pressure attains a predetermined maximum value before a no flow condition is achieved.

58. The device of claim 56 wherein the automatic inflation sequence inflates the cuff to a first pressure of 5 mmHg to 10 mmHg.

59. The device of claim 56 wherein the automatic inflation sequence inflates the cuff to the patient'"'"'s systolic pressure.

60. The device of claim 56 wherein the automatic inflation sequence increases the cuff pressure in predetermined increments of 40 mmHg until a no flow condition is achieved.

61. The device of claim 56 wherein the automatic deflation sequence comprises:

(a) releasing pressure from the cuff at a desired controlled rate;

(b) monitoring the deflation rate;

(c) aborting the deflation sequence if the deflation rate is not substantially equal to the desired controlled rate;

(d) analyzing whether a perfusion measurement qualifies as an SPP value using the testing means;

(e) determining whether at least one automatic stop criterion has been met;

(f) repeating steps (a)-(e) until at least one automatic stop criterion has been met;

(g) reporting the SPP value from step (d) if any.

62. The device of claim 61 wherein the automatic deflation sequence further comprises:

(a) after a predetermined number of repetitions of steps (a)-(e) in the absence of an acceptable SPP value, continuing to repeat steps (a)-(e) for a predetermined period of time;

(b) displaying perfusion measurements on a display for physician interpretation.

63. The device of claim 61 wherein analyzing whether a perfusion measurement qualifies as an acceptable SPP value comprises identifying that the measured perfusion pressure is not the result of motion artifact.

64. The device of claim 61 wherein qualifying the SPP value comprises determining whether the perfusion measurement is within 1 mmHg to approximately 150 mmHg.

65. The device of claim 61 wherein analyzing whether a perfusion measurement qualifies an acceptable SPP value comprises determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value.

66. The device of claim 65 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether at least one of the following criteria is met:

a perfusion measurement greater than 0.20% when cuff pressure is less than 100 mmHg, and the perfusion increase is from 10% and 50%;

a perfusion measurement greater than 0.20% when cuff pressure or greater than or equal to 100 mmHg, and the perfusion increase is from 20% and 80%;

a perfusion measurement of from 0.15% to 0.20% when the cuff pressure is any valid cuff pressure, and the perfusion increase is from 25% to 100%;

a perfusion measurement is less than 0.15%, when the cuff pressure is any valid cuff pressure, and the perfusion increase is from 50% to 200%.

67. The device of claim 65 wherein determining whether a perfusion increase from a prior measurement is greater than a predetermined minimum increase value comprises determining whether one of the following criteria is met:

a perfusion measurement greater than 0.20% with a cuff pressure less than 100 mmHg, and the perfusion increase is 25%;

a perfusion measurement greater than 0.20% with a cuff pressure greater than or equal to 100 mmHg, and the perfusion increase is 40%;

a perfusion measurement equal to from 0.15% to 0.20% with any valid cuff pressure, and the perfusion increase is 50%;

a perfusion measurement less than 0.15% with any valid cuff pressure, and the perfusion increase is 100%.

68. The device of claim 61 wherein analyzing whether a perfusion measurement qualifies as an acceptable SPP value comprises determining whether the perfusion measurement is from 0.05% to 0.2%.

69. The device of claim 61 wherein analyzing whether a perfusion measurement qualifies an acceptable SPP value comprises:

comparing the perfusion measurement to subsequent perfusion measurements to determine whether the subsequent perfusion measurements are increasing or decreasing;

qualifying the perfusion measurement as an SPP value if all conditions of the predetermined set of criteria are met, wherein one of the criteria met is selected from the group consisting of (i) a cuff pressure of from 0 to 20 mmHg and one subsequent perfusion measurement is increasing;

(ii) a cuff pressure of from 10 to 50 mmHg and two subsequent perfusion measurements are increasing;

(iii) a cuff pressure of from 40 to 120 mmHg and three subsequent perfusion measurements are increasing;

(iv) a cuff pressure greater than 80 mmHg and five subsequent perfusion measurements are increasing.

70. The device of claim 69 wherein qualifying the perfusion measurement as an SPP value comprises qualifying the perfusion measurement as an SPP value if all conditions of the predetermined set of criteria are met, wherein one of the criteria met is selected from the group consisting of (i) a cuff pressure less than 15 mmHg and one subsequent perfusion measurement is increasing;

(ii) a cuff pressure from 15 to 20 mmHg and two subsequent perfusion measurements are increasing;

(iii) a cuff pressure of from 50 to 100 mmHg and three subsequent perfusion measurements are increasing;

(iv) a cuff pressure of from 100 mmHg to 150 mmHg and five subsequent perfusion measurements are increasing.

71. The device of claim 61 wherein analyzing whether a perfusion measurement qualifies as an SPP value comprises:

defining a perfusion change profile;

determining whether the perfusion measurement is one of a sequence of perfusion measurements that fits the perfusion change profile.

72. The device of claim 71 wherein defining a perfusion change profile comprises defining a profile in which a measured perfusion measurement meets the criteria selected from the group consisting of (i) when cuff pressure is from 0 to 20 mmHg, a next subsequent perfusion measurement is not decreasing;

(ii) when cuff pressure is from 10 to 50 mmHg, two immediately subsequent perfusion measurements are not decreasing;

(iii) when cuff pressure is from 40 to 120 mmHg, three immediately subsequent perfusion measurements are not decreasing;

(iv) when cuff pressure is greater than 80 mmHg, five immediately subsequent perfusion measurements are not decreasing.

73. The device of claim 72 wherein defining a perfusion change profile comprises defining a profile in which a measured perfusion measurement meets the criteria selected from the group consisting of (i) when cuff pressure is less than 15 mmHg, a next subsequent perfusion measurement is not decreasing;

(ii) when cuff pressure is from 15 to 20 mmHg, two immediately subsequent perfusion measurements are not decreasing;

(iii) when cuff pressure is from 50 to 100 mmHg, three immediately subsequent perfusion measurements are not decreasing;

(iv) when cuff pressure is from 100 mmHg to 150 mmHg, five immediately subsequent perfusion measurements are not decreasing.