Noninvasive detection of a physiologic parameter with a probe

Abstract

The invention provides a device for contacting a surface of a patient's body to determine a physiologic parameter in a measurement region of a tissue of the patient. The device typically comprises a sensor responsive to the physiologic parameter and a probe housing the sensor. The probe is constructed to allow the sensor to be secured at a sensing site adjacent to the measurement region, without disturbing the blood flow within the measurement region of the tissue. The device may also include a means for reducing interference in the sensing area. Preferably, the device further comprises an indicating means operably connected to the sensor for indicating an analyte quantity and / or concentration associated with the physiologic parameter.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. application Ser. No. 10 / 366,903, filed Feb. 14, 2003, now abandoned, which is a continuation-in-part of U.S. application Ser. No. 10 / 162,028, filed Jun. 3, 2002, now abandoned, the entireties of which are hereby incorporated by reference.TECHNICAL FIELD [0002] The present invention relates generally to devices and methods for noninvasive detection of a physiologic parameter within a tissue of a patient. More particularly, the invention relates to such devices and methods that allow a probe containing at least one sensor to be placed adjacent to a surface of the tissue, without substantially disturbing blood flow in the tissue, and / or without interference from interfering fluids or radiation. BACKGROUND [0003] There is a continuing need for improved devices and methods for determining one or more physiologic parameters of a patient. Often, such physiologic parameters are determined by de...

AI Technical Summary

Benefits of technology

[0014] Accordingly, it is an object of the present invention to overcome the above-mentioned disadvantages of the prior art by providing a device that provides for non-invasive and accurate determination of a physiologic parameter of a patient within a tissue of a patient.

[0021] In a general aspect, then, the present invention relates a device for contacting a surface of a tissue within a patient's body to determine a physiologic parameter of the patient. The device provides a sensor responsive to the physiologic parameter and a means for preventing application of excessive pressure to the tissue at a measurement region in the tissue. The sensor is located within a sensing area adjacent to the measurement region. The means for preventing application of excessive pressure allows for substantially undisturbed blood flow in the tissue when contact is established between the device and the tissue. Typically, the physiologic parameter may be associated with parameters such as O2, blood flow, blood pressure, heart beat or pulse and / or tissue analytes. The device may be constructed to engage in trans-tissue or intra-tissue measurement of the quantity or concentration of the analyte. The tissue may be epithelium; connective; muscle or nerve. The mucosa is a tissue that is well suited for measurements utilizing the device of the present invention. In an alternative embodiment, the device of the present invention may also be used on the epidermis and trans-tissue measurements are taken as noted above. An indicating means may also be provided and is operably connected to the sensor for indicating analyte concentration in the patient.

[0024] The device may include one or more sensors. The invention is particularly suited for the measurement of physiologic parameters including mechanical, respiratory and metabolic parameters. There exists an advantage to the physician in taking at least one measurement from each of these three categories of physiologic parameters because the combination of these measurements provides a more complete data set to the physician allowing her to more accurately diagnosis the medical condition. Thus, the invention is particularly suited for use with a sensor responsive to parameters such as a gas, e.g., oxygen, carbon dioxide, nitrous oxide, desflurane, enflurane, halothane, isoflurane, methoxyflurane, and sevoflurane. In addition, the invention is also particularly suited for use with a sensor responsive to other parameters such as tissue pH, blood pressure, blood flow, pulse, heart contraction and tissue analytes. In particular the sensor may measure physiologic parameters either directly through such means as laser-doppler, ultrasound, microspheres, radioactive isotopes and other such means, or indirectly through the measurement of tissue pH, temperature, CO2, pCO2, O2, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and other analytes associated with the tricarboxylic acid cycle. To assure the accuracy and / or precision of the performance of device, the device may include a temperature detecting means for detecting temperature at the sensor. In some instances, the temperature detecting means is detachable with respect to the device.

[0025] The device may further include a sheath covering the device. The sheath may be reusable or disposable. Such a sheath may be employed irrespective of whether the device is adapted for single use or multiple uses. The sheath typically has a selectively permeable portion that allows transmission of an analyte therethrough. For example, the selectively permeable portion may be formed from a permeable silicone or other porous membrane. For ease in handling, the sheath may include a rigid portion.

Problems solved by technology

Noninvasive techniques for analyte detection are preferred over invasive detection techniques because invasive procedures result in stress and discomfort to patients.

First, drawing blood requires the puncturing of a patient's skin and creates a risk of infection.

Second, hypodermic needles used in drawing blood may also pose a risk of accidental infection to health care professionals such as phlebotomists who routinely use the needles and sanitary workers who handle contaminated needles.

Third, the technique of drawing blood and in vitro testing is not easily adaptable for real-time and continuous monitoring of changes in analyte.

Excessive sedation may cause permanent injury to the patient, sometimes resulting in death, and insufficient sedation is ineffective to suppress pain.

However, improper maintenance may subject the liquid electrolyte to evaporation or drying, thereby compromising the accuracy of analyte detection.

Thus, this approach suffers from the drawback that the electrode apparatus must be meticulously maintained.

Improper placement of such a sensor through use of the catheter may cause blanching of the tissue in which analyte is measured, i.e., occlusion of fluid flow therein, Moreover, during use, this type of device is highly susceptible to being inadvertently rotated to an improper angle or otherwise moved out of proper position for accurate analyte detection.

There are a number of challenges associated with the accuracy of non-invasive detection of CO2 and / or O2 in exposed tissue.

It has now been discovered that various factors may compromise the usefulness or accuracy of measurement for certain tissue analytes associated with useful physiologic parameters, in particular, gaseous analytes such as O2 and CO2.

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