P
USRE44875EExpiredUtilityPatentIndex 99

Active pulse blood constituent monitoring

Assignee: KIANI MASSI JOE EPriority: Jun 7, 1995Filed: Mar 14, 2011Granted: Apr 29, 2014
Est. expiryJun 7, 2015(expired)· nominal 20-yr term from priority
Inventors:KIANI MASSI JOE EDIAB MOHAMED KHEIRLEPPER JR JAMES M
A61B 5/1455A61B 5/14532A61B 2560/0462A61B 5/14552A61B 5/6838A61B 5/6826
99
PatentIndex Score
762
Cited by
209
References
49
Claims

Abstract

A blood constituent monitoring method for inducing an active pulse in the blood volume of a patient. The induction of an active pulse results in a cyclic, and periodic change in the flow of blood through a fleshy medium under test. By actively inducing a change of the blood volume, modulation of the volume of blood can be obtained to provide a greater signal to noise ratio. This allows for the detection of constituents in blood at concentration levels below those previously detectable in a non-invasive system. Radiation which passes through the fleshy medium is detected by a detector which generates a signal indicative of the intensity of the detected radiation. Signal processing is performed on the electrical signal to isolate those optical characteristics of the electrical signal due to the optical characteristics of the blood.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A system for non-invasively monitoring concentrations of blood constituents in a living subject, said system comprising:
 a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration; 
 an optical detector configured to be positioned at said measurement site to detect only light which has been attenuated by said fleshy medium at said measurement site, said optical detector configured to generate an output signal indicative of an intensity of said radiation after attenuation through said fleshy medium; 
 a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood of determining at least said glucose concentration, said pressure application device configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; and 
 a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood and to determine a concentration of at least one selected constituent within said subject's bloodstream; and a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that said signal processor can determine at least said glucose concentration. by analyzing an effect of the modulated pressure on the output signal. 
 
     
     
       2. The system of  claim 1 , wherein said change in said volume of blood alters said output signal such that a difference in said output signal at a full blood volume and said output signal at said changed output volume comprises about 1 to about 10 percent. 
     
     
       3. The system of  claim 2 , wherein said difference comprises about 10 percent. 
     
     
       4. The system of  claim 1 , wherein at least one of said plurality of wavelengths comprises about 660 nanometers (nm). 
     
     
       5. The system of claim  4  1, wherein said at least one wavelength of said plurality of wavelengths is selected for attenuation sensitivity to a hemoglobin concentration. 
     
     
       6. The method system of  claim 1 , wherein said light source comprises two or more light emitting diodes. 
     
     
       7. A method of non-invasively monitoring concentrations of blood constituents in a living subject, said method comprising:
 irradiating a fleshy medium of a living subject at a measurement site with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality, of blood constituent concentrations including a glucose concentration; 
 detecting at said measurement site only light which has been attenuated by said fleshy medium; 
 outputting a signal indicative of the intensity of said radiation after attenuation through said fleshy medium; 
 using a device external to said fleshy medium, changing a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site, said device external to said fleshy medium configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; 
 extracting portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject's bloodstream based on an effect of the modulated pressure on the output signal; and  
 using a device external to said fleshy medium, changing a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site; and 
 causing said glucose concentration to be displayed. 
 
     
     
       8. A method of non-invasively monitoring glucose concentrations in a living subject, said method comprising:
 applying pressure at a first location to a fleshy medium to increase a likelihood of determining a glucose concentration in a living subject, said pressure applied to said fleshy medium at a modulated rate above a normal heart rate range; 
 detecting only light attenuated by said fleshy medium at a second location different from said first location, wherein said applying pressure does not apply direct mechanical pressure to said second location; 
 outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said glucose concentration at a resolution differentiable from noise or other blood constituents; 
 determining at least said glucose concentration by analyzing an effect of the pressure on said output signal; and 
 causing said glucose concentration to be displayed. 
 
     
     
       9. A system for non-invasively monitoring concentrations of blood constituents in a living subject, said system comprising:
 a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration, wherein said light source comprises two or more light emitting diodes; 
 an optical detector configured to be positioned at said measurement site to detect light which has been attenuated by said fleshy medium, said optical detector configured to generate an output signal indicative of the intensity of said radiation after attenuation through said fleshy medium; 
 a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood of determining at least said glucose concentration, said pressure application device configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; and 
 a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood and to determine a concentration of at least one selected constituent within said subject's bloodstream; and a pressure application device configured to be positioned at a location different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that said signal processor can determine at least said glucose concentration by analyzing an effect of the modulated pressure on the output signal. 
 
     
     
       10. The system of  claim 9 , wherein said optical detector detects light which has been attenuated by said fleshy medium at one location. 
     
     
       11. The system of  claim 9 , wherein the pressure application device comprises an inflatable bladder. 
     
     
       12. The system of  claim 9 , further comprising a temperature variation element. 
     
     
       13. The system of  claim 12 , wherein said temperature variation element cyclically varies the temperature of said fleshy medium in order to induce a change in the flow of blood in said fleshy medium. 
     
     
       14. The system of  claim 9 , wherein said two or more light emitting diodes are configured to produce light at a plurality of wavelengths, each wavelength selected for attenuation sensitivity to determine a concentration of said at least one selected constituent. 
     
     
       15. A method of non-invasively monitoring concentrations of blood constituents in a living subject, said method comprising:
 irradiating a fleshy medium of a living subject at a measurement site with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration, wherein irradiating comprises using two or more light emitting diodes; 
 detecting at said measurement site light which has been attenuated by said fleshy medium; 
 outputting a signal indicative of the detected light; 
 using a device external to said fleshy medium, changing a volume of blood in the fleshy medium sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site, said device external to said fleshy medium configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; 
 extracting portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject's bloodstream by analyzing an effect of the modulated pressure on the output signal; and  
 using a device external to said fleshy medium, changing a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood that at least said glucose concentration can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site; and 
 causing said glucose concentration to be displayed. 
 
     
     
       16. The method of  claim 15 , wherein the step of detecting further comprise comprises detecting at said measurement site light which has been attenuated by said fleshy medium at one location. 
     
     
       17. A method of non-invasively monitoring glucose concentrations in a living subject, said method comprising:
 irradiating a fleshy medium of a living subject using two or more light emitting diodes; 
 applying pressure at a first location to a fleshy medium to increase a likelihood of determining a glucose concentration in a living subject, said pressure applied to said fleshy medium at a modulated rate above a normal heart rate range; 
 detecting light attenuated by said fleshy medium at a second location different from said first location, wherein said applying pressure does not apply direct mechanical pressure to said fleshy medium at said second location; 
 outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said glucose concentration at a resolution differentiable from noise or other blood constituents; 
 determining at least said glucose concentration by analyzing an effect of the pressure on the output signal; and 
 causing glucose concentration to be displayed. 
 
     
     
       18. The method of  claim 17 , wherein the step of detecting further comprises detecting light attenuated through a single location of said fleshy medium. 
     
     
       19. The method of  claim 17 , wherein applying pressure comprises inflating a bladder. 
     
     
       20. The method of  claim 17 , further comprising cyclically varying the temperature of said fleshy medium in order to induce a change in the flow of blood in said fleshy medium. 
     
     
       21. A system for non-invasively monitoring a blood constituent in a living subject, said system comprising:
 a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituents;   an optical detector configured to be positioned at said measurement site to detect light which has been attenuated by said fleshy medium at said measurement site, said optical detector configured to generate an output signal indicative of an intensity of said radiation after attenuation through said fleshy medium;   a pressure application device configured to be positioned at a location proximal to said measurement site but different from said measurement site to avoid applying direct pressure to said measurement site while causing a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood of determining a level of at least one selected constituent within said subject's bloodstream, said pressure application device configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; and   a signal processor responsive to said output signal to analyze said output signal to extract portions of said signal due to optical characteristics of said blood and to determine said level by analyzing an effect of the modulated pressure on the output signal.   
     
     
       22. The system of claim 21, wherein said change in said volume of blood comprises causing evacuation of said volume of blood at said measurement site. 
     
     
       23. The system of claim 22, wherein said evacuation causes an overall difference in optical attenuation from a full blood state of approximately 10%. 
     
     
       24. The system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises glucose. 
     
     
       25. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises hemoglobin. 
     
     
       26. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises oxyhemoglobin. 
     
     
       27. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises carboxyhemoglobin. 
     
     
       28. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises oxygen saturation. 
     
     
       29. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises venous oxygen saturation. 
     
     
       30. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises protein. 
     
     
       31. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises fat. 
     
     
       32. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises cholesterol. 
     
     
       33. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises a therapeutic drug. 
     
     
       34. A system of claim 21, wherein said at least one selected constituent within said subject's bloodstream comprises a drug of abuse. 
     
     
       35. A method of non-invasively monitoring a blood constituent in a living subject, said method comprising:
 applying pressure at a first location to a fleshy medium to increase a likelihood of determining a level of said blood constituent, said pressure applied to said fleshy medium at a modulated rate above a normal heart rate range;   detecting light attenuated by said fleshy medium at a second location distal to said first location, wherein said applying pressure does not apply direct mechanical pressure to said second location;   electronically outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said level at a resolution differentiable from noise or other blood constituents, and wherein said signal is affected by the modulation from said application of pressure at said first location; and   electronically determining at least said level using said signal and analyzing an effect of the modulation on said signal.   
     
     
       36. The method of claim 35, wherein applying a first pressure comprises causing an evacuation of a volume of blood at said first location. 
     
     
       37. The method of claim 36, wherein said evacuation causes an overall difference in optical attenuation from a full blood state of approximately 10%. 
     
     
       38. The method of claim 35, further comprising displaying an indication of said level. 
     
     
       39. The method of claim 35, wherein said blood constituent is one or more of glucose, hemoglobin, oxyhemoglobin, carboxyhemoglobin, oxygen saturation, venous oxygen saturation, protein, fat, cholesterol, therapeutic drug, drug of abuse, and water. 
     
     
       40. A method of non-invasively monitoring a blood constituent in a living subject, said method comprising:
 irradiating a fleshy medium of a living subject at a measurement site with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituents, wherein irradiating comprises using two or more light emitting diodes;   detecting at said measurement site light which has been attenuated by said fleshy medium;   electronically outputting a signal indicative of the detected light;   using a device external to said fleshy medium proximal to said measurement site, changing a volume of blood in the fleshy medium sufficient to alter said output signal to increase a likelihood that at least a level of at least one selected constituent within said subject's bloodstream can be determined without applying direct mechanical pressure to said fleshy medium at said measurement site, said device external to said fleshy medium configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; and   electronically extracting portions of said signal due to optical characteristics of said blood and determining said level by analyzing an effect of the modulated pressure on the output signal.   
     
     
       41. The method of claim 40, further comprising displaying an indication of said level. 
     
     
       42. The method of claim 40, wherein said at least one selected constituent is one or more of glucose, hemoglobin, oxyhemoglobin, carboxyhemoglobin, oxygen saturation, venous oxygen saturation, protein, fat, cholesterol, therapeutic drug, drug of abuse, and water. 
     
     
       43. A method of non-invasively monitoring a blood constituent in a living subject, said method comprising:
 irradiating a fleshy medium of a living subject using two or more light emitting diodes;   applying pressure at a first location to a fleshy medium to increase a likelihood of determining a level of said blood constituent, said pressure applied to said fleshy medium at a modulated rate above a normal heart rate range;   detecting light attenuated by said fleshy medium at a second location distal to said first location, the first location substantially in the region about the second location, wherein said applying pressure does not apply direct mechanical pressure to said fleshy medium at said second location;   electronically outputting a signal indicative of said detected attenuated light, wherein said signal includes information about said level at a resolution differentiable from noise or other blood constituents, and wherein said signal is affected by the modulation from said application of pressure at said first location; and   electronically determining at least said level using said signal.   
     
     
       44. The method of claim 43, further comprising displaying an indication of said level. 
     
     
       45. The method of claim 43, wherein said blood constituent is one or more of glucose, hemoglobin, oxyhemoglobin, carboxyhemoglobin, oxygen saturation, venous oxygen saturation, protein, fat, cholesterol, therapeutic drug, drug of abuse, and water. 
     
     
       46. A system for non-invasively monitoring concentrations of blood constituents in a living subject, said system comprising:
 a light source configured to be positioned at a measurement site and further configured to irradiate a fleshy medium of a living subject with radiation at a plurality of wavelengths selected for attenuation sensitivity to at least one of a plurality of blood constituent concentrations, said plurality of blood constituent concentrations including a glucose concentration;   an optical detector configured to be positioned at said measurement site to detect light which has been attenuated by said fleshy medium at said measurement site, said optical detector configured to generate an output signal indicative of an intensity of said radiation after attenuation through said fleshy medium;   a pressure application device configured cause a change in a volume of blood in the fleshy medium at said measurement site sufficient to alter said output signal to increase a likelihood of determining at least said glucose concentration, said pressure application device configured to modulate pressure on the fleshy medium at a rate above a normal heart rate range; and   a signal processor responsive to said output signal to analyze at least an effect of the modulated pressure on the fleshy medium on said output signal and to extract portions of said signal due to optical characteristics of said blood to determine a concentration of at least one selected constituent within said subject's bloodstream by analyzing an effect of the modulated pressure on the output signal.   
     
     
       47. The system of claim 46, wherein at least one of said plurality of wavelengths comprises about 660 nanometers (nm). 
     
     
       48. The system of claim 46, wherein said at least one wavelength is selected for attenuation sensitivity to a hemoglobin concentration. 
     
     
       49. The system of claim 46, wherein said light source comprises two or more light emitting diodes.

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