WO2004017905A2 - Method and apparatus for noninvasively evaluating endothelial function - Google Patents

Method and apparatus for noninvasively evaluating endothelial function Download PDF

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Publication number
WO2004017905A2
WO2004017905A2 PCT/US2003/026238 US0326238W WO2004017905A2 WO 2004017905 A2 WO2004017905 A2 WO 2004017905A2 US 0326238 W US0326238 W US 0326238W WO 2004017905 A2 WO2004017905 A2 WO 2004017905A2
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WO
WIPO (PCT)
Prior art keywords
patient
monitoring
endothelial function
change
selected region
Prior art date
Application number
PCT/US2003/026238
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French (fr)
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WO2004017905A3 (en
Inventor
Nachiket Kaharalkar
Morteza Naghavi
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The Board Of Regents Of University Of Texas System
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Application filed by The Board Of Regents Of University Of Texas System filed Critical The Board Of Regents Of University Of Texas System
Priority to US10/525,255 priority Critical patent/US20060165596A1/en
Publication of WO2004017905A2 publication Critical patent/WO2004017905A2/en
Publication of WO2004017905A3 publication Critical patent/WO2004017905A3/en
Priority to US11/871,901 priority patent/US8551008B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations

Definitions

  • TITLE Method and Apparatus for Noninvasively Evaluating Endothelial
  • the present invention relates generally to the field of assessing a patient's endothelial function by monitoring changes in hemodynamic parameters responsive to the introduction of a vasodilating stimulant.
  • the monitored hemodynamic parameters may include blood temperature, blood flow, and/or blood oxygen content.
  • cardiovascular disease and its sequel account for a significant percentage of the morbidity or mortality in industrialized countries. It is known that cardiovascular disease may be caused and/or enhanced by an impairment of tissue perfusion.
  • the endothelium has many important functions in maintaining the patency and integrity of the arterial system.
  • the endothelium can reduce and inactivate toxic super-oxides which may be present in diabetics and in smokers.
  • the endothelium is the source of nitric oxide, a local hormone that relaxes the adjacent smooth muscle cells in the media, and is a powerful vasodilator.
  • endothelium regulates vascular homeostasis by elaborating a variety paracrine that act locally in the blood vessel wall and lumen. Under normal conditions, these aspects of the endothelium, hereinafter referred to as "endothelial factors,” maintain normal vascular tone, blood fluidity, and limit vascular inflammation and smooth muscle cell proliferation.
  • the endothelium may adopt a phenotype that facilitates inflammation, thrombosis, vasoconstriction, and atherosclerotic lesion formation.
  • the maladaptive endothelial phenotype manifests itself prior to the development of frank atherosclerosis and is associated with traditional risk factors such as hypercholesterolemia, hypertension, and diabetes mellitus.
  • the maladaptive endothelial phenotype is further identified with emerging risk factors such hyperhomocystinemia, obesity, and systemic inflammation.
  • Prior art means for estimating endothelial dysfunction include the use of cold pressure tests by invasive quantitative coronary angiography and the injection of radioactive material and subsequent tracking of radiotracers in the blood. These invasive methods are costly, inconvenient, and must be administered by highly trained medical practitioners.
  • Noninvasive prior art methods for measuring endothelial dysfunction include, the measurement of the percent change and the diameter of the left main trunk induced by cold pressure test with two dimensional echo cardiography, the Dundee step test, laser doppler perfusion imaging and iontophoresis, and high resolution b-mode ultrasound.
  • endothelial function may be assessed by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in a hemodynamic parameter at the selected region; and assessing the patient's endothelial function based upon said monitoring.
  • endothelial function may be measured by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in blood oxygen content at the selected region; and assessing the patient's endothelial function based upon said monitoring.
  • endothelial function may be measured by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in blood flow rate at the selected region; and assessing the patient's endothelial function based upon said monitoring.
  • FIG. 1 is a flowchart of a first preferred embodiment of a method of endothelial function assessment
  • FIG. 2 is a flowchart of a second preferred embodiment of a method of endothelial function measurement.
  • FIG. 3 is a flowchart of a second preferred embodiment of a method of endothelial function measurement.
  • a preferred method for assessing endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 100 in Fig. 1; monitoring a change in a hemodynamic parameter at the selected region, illustrated at block 110 in Fig. 1; and assessing the patient's endothelial function based upon said monitoring, illustrated at block 120 in Fig. 1.
  • the monitored hemodynamic parameter may be a parameter such as blood temperature, blood oxygen content, blood flow rate, or the like, or a combination thereof.
  • Providing a vasodilating stimulant may further comprise compressing the patient's brachial artery for a predetermined period of time and ceasing the compression after that predetermined period of time.
  • Providing a vasodilating stimulant may also comprise occluding blood flow in the patient's arm.
  • the change in temperature at one of the patient's fingertips may be monitored as may the change in temperature in the patient's arm. Monitoring the change in temperature may be accomplished by placing at least two temperature sensors, for example piezoelectric sensors, proximate, e.g. on, the patient's forearm. The temperature sensors may be separated by a known distance.
  • Providing a vasodilating stimulant may comprise occluding blood flow in the patient's leg.
  • a preferred method for measuring endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 200 in Fig. 2.; monitoring a change in blood oxygen content at the selected region, illustrated at block 210 in
  • Monitoring may be accomplished by taking measurements with a pulse oximeter.
  • the pulse oximeter may be placed proximate, e.g. on, the tip of one of the patient's fingers.
  • a second preferred method for measuring endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 300 in Fig. 3; monitoring a change in blood flow rate at the selected region, illustrated at block 310 in Fig.
  • Monitoring may be accomplished by taking measurements with a photoplethysmograph placed proximate, e.g. on, one of the patient's fingers. Monitoring may also be accomplished by taking an ultrasound Doppler measurement. Monitoring may occurs from a time prior to the beginning of the compression until a time after ceasing, e.g. when blood flow has stabilized.
  • Providing a vasodilating stimulant may comprise compressing one of the patient's arteries located in an outer extremity of the patient's body for a predetermined period of time and ceasing the compression after said predetermined period of time.
  • the outer extremity may be a leg, an arm, a wrist, and/or a finger.
  • the second preferred method for measuring endothelial function may further comprise plotting measured blood flow as a function of time and/or plotting the change in blood flow as a function of time.
  • the present invention may be used to assess a patient's endothelial function by monitoring changes in hemodynamic parameters responsive to the introduction of a vasodilating stimulant.
  • the monitored hemodynamic parameters may include blood temperature, blood flow, and/or blood oxygen content.

Abstract

The present invention relates to assessing and measuring endothelial functions. A vasodilating stimulant is provided to a patient to stimulate hemodynamic activity in a selected region of the patient's body. In an embodiment, endothelial function may then be assessed by monitoring a change in a hemodynamic parameter at the selected region and assessing the patient's endothelial function based upon that monitoring. In a further embodiment, endothelial function may then be measured by monitoring a change in blood oxygen content at the selected region and assessing the patient's endothelial function based upon that monitoring. In yet a further embodiment, endothelial function may then be measured by monitoring a change in blood flow rate at the selected region and assessing the patient's endothelial function based upon said monitoring. It is emphasized that this abstract is provided to comply with the rules requiring an abstract which will allow a searcher or other reader to quickly ascertain the subject matter of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Description

TITLE: Method and Apparatus for Noninvasively Evaluating Endothelial
Function
PRIORITY
[0001] This application claims the benefit of U. S. Provisional Patent Application
Serial No. 60/405,352 filed on August 23, 2002.
FIELD OF INVENTION
[0002] The present invention relates generally to the field of assessing a patient's endothelial function by monitoring changes in hemodynamic parameters responsive to the introduction of a vasodilating stimulant. The monitored hemodynamic parameters may include blood temperature, blood flow, and/or blood oxygen content.
BACKGROUND OF THE INVENTION
[0003] Cardiovascular disease and its sequel account for a significant percentage of the morbidity or mortality in industrialized countries. It is known that cardiovascular disease may be caused and/or enhanced by an impairment of tissue perfusion.
[0004] The endothelium has many important functions in maintaining the patency and integrity of the arterial system. The endothelium can reduce and inactivate toxic super-oxides which may be present in diabetics and in smokers. The endothelium is the source of nitric oxide, a local hormone that relaxes the adjacent smooth muscle cells in the media, and is a powerful vasodilator.
[0005] The endothelium regulates vascular homeostasis by elaborating a variety paracrine that act locally in the blood vessel wall and lumen. Under normal conditions, these aspects of the endothelium, hereinafter referred to as "endothelial factors," maintain normal vascular tone, blood fluidity, and limit vascular inflammation and smooth muscle cell proliferation.
[0006] When coronary risk factors are present, the endothelium may adopt a phenotype that facilitates inflammation, thrombosis, vasoconstriction, and atherosclerotic lesion formation. In human patients, the maladaptive endothelial phenotype manifests itself prior to the development of frank atherosclerosis and is associated with traditional risk factors such as hypercholesterolemia, hypertension, and diabetes mellitus. The maladaptive endothelial phenotype is further identified with emerging risk factors such hyperhomocystinemia, obesity, and systemic inflammation.
[0007] Prior art means for estimating endothelial dysfunction include the use of cold pressure tests by invasive quantitative coronary angiography and the injection of radioactive material and subsequent tracking of radiotracers in the blood. These invasive methods are costly, inconvenient, and must be administered by highly trained medical practitioners. [0008] Noninvasive prior art methods for measuring endothelial dysfunction include, the measurement of the percent change and the diameter of the left main trunk induced by cold pressure test with two dimensional echo cardiography, the Dundee step test, laser doppler perfusion imaging and iontophoresis, and high resolution b-mode ultrasound. SUMMARY OF THE INVENTION
[0009] In an embodiment, endothelial function may be assessed by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in a hemodynamic parameter at the selected region; and assessing the patient's endothelial function based upon said monitoring. [0010] In a further embodiment, endothelial function may be measured by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in blood oxygen content at the selected region; and assessing the patient's endothelial function based upon said monitoring.
[0011] In yet a further embodiment, endothelial function may be measured by providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; monitoring a change in blood flow rate at the selected region; and assessing the patient's endothelial function based upon said monitoring.
[0012] It is emphasized that this summary is not to be interpreted as limiting the scope of these inventions which are limited only by the claims herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Fig. 1 is a flowchart of a first preferred embodiment of a method of endothelial function assessment;
[0014] Fig. 2 is a flowchart of a second preferred embodiment of a method of endothelial function measurement; and
[0015] Fig. 3 is a flowchart of a second preferred embodiment of a method of endothelial function measurement.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE
INVENTION
[0016] As used herein, that which is described as software may be equivalently implemented as hardware.
[0017] Referring now to Fig. 1, a preferred method for assessing endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 100 in Fig. 1; monitoring a change in a hemodynamic parameter at the selected region, illustrated at block 110 in Fig. 1; and assessing the patient's endothelial function based upon said monitoring, illustrated at block 120 in Fig. 1. In a preferred embodiment, the monitored hemodynamic parameter may be a parameter such as blood temperature, blood oxygen content, blood flow rate, or the like, or a combination thereof.
[0018] Providing a vasodilating stimulant may further comprise compressing the patient's brachial artery for a predetermined period of time and ceasing the compression after that predetermined period of time. Providing a vasodilating stimulant may also comprise occluding blood flow in the patient's arm.
[0019] Additionally, the change in temperature at one of the patient's fingertips may be monitored as may the change in temperature in the patient's arm. Monitoring the change in temperature may be accomplished by placing at least two temperature sensors, for example piezoelectric sensors, proximate, e.g. on, the patient's forearm. The temperature sensors may be separated by a known distance.
[0020] Providing a vasodilating stimulant may comprise occluding blood flow in the patient's leg.
[0021] Referring now to Fig. 2, in a preferred method for measuring endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 200 in Fig. 2.; monitoring a change in blood oxygen content at the selected region, illustrated at block 210 in
Fig. 2.; and assessing the patient's endothelial function based upon said monitoring, illustrated at block 210 in Fig. 2.
[0022] . Monitoring may be accomplished by taking measurements with a pulse oximeter. The pulse oximeter may be placed proximate, e.g. on, the tip of one of the patient's fingers.
[0023] Referring now to Fig. 3, a second preferred method for measuring endothelial function comprises providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body, illustrated at block 300 in Fig. 3; monitoring a change in blood flow rate at the selected region, illustrated at block 310 in Fig.
3; and assessing the patient's endothelial function based upon said monitoring, illustrated at block 320 in Fig. 3.
[0024] Monitoring may be accomplished by taking measurements with a photoplethysmograph placed proximate, e.g. on, one of the patient's fingers. Monitoring may also be accomplished by taking an ultrasound Doppler measurement. Monitoring may occurs from a time prior to the beginning of the compression until a time after ceasing, e.g. when blood flow has stabilized.
[0025] Providing a vasodilating stimulant may comprise compressing one of the patient's arteries located in an outer extremity of the patient's body for a predetermined period of time and ceasing the compression after said predetermined period of time. The outer extremity may be a leg, an arm, a wrist, and/or a finger.
[0026] The second preferred method for measuring endothelial function may further comprise plotting measured blood flow as a function of time and/or plotting the change in blood flow as a function of time.
[0027] It will be understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated above in order to explain the nature of this invention may be made by those skilled in the art without departing from the principle and scope of the invention as recited in the appended claims.
STATEMENT OF INDUSTRIAL USE
[0028] The present invention may be used to assess a patient's endothelial function by monitoring changes in hemodynamic parameters responsive to the introduction of a vasodilating stimulant. The monitored hemodynamic parameters may include blood temperature, blood flow, and/or blood oxygen content.

Claims

CLAIMS:What is claimed is:
1. A method for assessing endothelial function, comprising: a. providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; b. monitoring a change in a hemodynamic parameter at the selected region; and c. assessing the patient's endothelial function based upon said monitoring.
2. The method of claim 1 , wherein providing a vasodilating stimulant comprises: a. compressing the patient's brachial artery for a predetermined period of time; and b. ceasing said compression after said predetermined period of time.
3. The method of claim 2, wherein said monitoring further comprises monitoring a change in temperature at one of the patient's fingertips.
4. The method of claim 1 , wherein providing a vasodilating stimulant comprises occluding blood flow in the patient's arm.
5. The method of claim 4, wherein said monitoring comprises monitoring a change in temperature in the patient's arm.
6. The method of claim 5, wherein monitoring the change in temperature in the patient's arm is accomplished by placing at least two temperature sensors proximate the patient's forearm.
7. The method of claim 6, wherein the temperature sensors are piezoelectric sensors.
8. The method of claim 1, wherein the hemodynamic parameter is at least one of (i) blood temperature, (ii) blood oxygen content, or (iii) blood flow rate.
9. The method of claim 1, wherein providing a vasodilating stimulant comprises occluding blood flow in the patient's leg.
10. A method for measuring endothelial function, comprising: a. providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; b. monitoring a change in blood oxygen content at the selected region; and c. assessing the patient's endothelial function based upon said monitoring.
11. The method of claim 10, wherein said monitoring is accomplished by taking measurements with a pulse oximeter.
12. The method of claim 11, wherein said pulse oximeter is placed proximate the tip of one of the patient's fingers.
13. A method for measuring endothelial function, comprising: a. providing a vasodilating stimulant to a patient to stimulate hemodynamic activity in a selected region of the patient's body; b. monitoring a change in blood flow rate at the selected region; and c. assessing the patient's endothelial function based upon said monitoring.
14. The method of claim 13, wherein said monitoring is accomplished by taking measurements with a photoplethysmograph placed proximate one of the patient's fingers.
15. The method of claim 13, wherein said monitoring is accomplished by taking an ultrasound Doppler measurement.
16. The method of claim 13, wherein providing a vasodilating stimulant comprises: a. compressing one of the patient's arteries located in an outer extremity of the patient's body for a predetermined period of time; and b. ceasing said compression after said predetermined period of time.
17. The method of claim 16, wherein the extremity is at least one of (i) a leg, (ii) an arm, (iii) a wrist, of (iv) a finger.
18. The method of claim 17, wherein said monitoring occurs from a time prior to the beginning of said compression until a time after said ceasing when said blood flow has stabilized.
19. The method of claim 18, further comprising plotting measured blood flow as a function of time.
20. The method of claim 19, further comprising plotting the change in blood flow as a function of time.
PCT/US2003/026238 2002-08-23 2003-08-22 Method and apparatus for noninvasively evaluating endothelial function WO2004017905A2 (en)

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US11/871,901 US8551008B2 (en) 2002-08-23 2007-10-12 Method and apparatus for determining vascular health conditions

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US60/405,352 2002-08-23

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US11/871,901 Continuation-In-Part US8551008B2 (en) 2002-08-23 2007-10-12 Method and apparatus for determining vascular health conditions

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