WO2000053080A1 - A device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals - Google Patents
A device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals Download PDFInfo
- Publication number
- WO2000053080A1 WO2000053080A1 PCT/IL1999/000621 IL9900621W WO0053080A1 WO 2000053080 A1 WO2000053080 A1 WO 2000053080A1 IL 9900621 W IL9900621 W IL 9900621W WO 0053080 A1 WO0053080 A1 WO 0053080A1
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- Prior art keywords
- cover
- organ
- blood
- tissue
- patient
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6813—Specially adapted to be attached to a specific body part
- A61B5/6825—Hand
- A61B5/6826—Finger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
- A61B5/14552—Details of sensors specially adapted therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6838—Clamps or clips
Definitions
- the present invention is in the field of non-invasive measurements of physiological parameters of patients, and relates to a device for the enhancement and quality improvement of blood-related signals.
- Non-invasive methods for measuring various blood-related parameters have become very popular due to the fact that these measurements, in distinction to invasive ones, have no such undesirable requirement as physical withdraw of a blood sample from the patient's body.
- Non-invasive measurements are based on the pulsatile nature of arterial blood, and utilize optical monitoring techniques capable of detecting such pulsatile blood behavior. Results obtained from pulse measurements can be used for determining various physiological parameters such as blood oxygen saturation, hematocrit, the concentration of hemoglobin, glucose, carbon dioxide, arterial blood pressure, etc.
- the optical monitoring techniques of the kind specified typically utilize the detection of light transmitted or reflected from different locations on the patient's body. According to some of these techniques, disclosed for example in U.S. Patent Nos. 5,101,825, changes in the blood parameters at a specific location are measured as a function of changes in the blood volume at this location. Other techniques, disclosed for example in U.S. Patent No. 5,499,627, utilize impedance measurements.
- the natural pulse signals are either detected and used for measurements, or created by performing various suitable procedures which are typically based on the use of a probe applied to the patient's finger (pulse oximetry) or other extremities.
- These methods typically require well-established, stable and reproducible capillary, venous and arterial blood presence at the location under measurement.
- slight homogeneous pressure may be applied to the soft tissue in the vicinity of the measurement location.
- such a pressure-inducing holder is usually a part of the measurement probe itself, i.e. it is associated with a specific sensor used in a specific measurement system.
- a pressure-inducing element can be applied to the patient's finger prior to the measurement itself, so as to create the required preconditions for starting blood-related measurements.
- Some of the conventional measuring devices utilize folded adhesive sensors, namely disposable adhesive sensors with optics embedded therein.
- Other devices utilize non-disposable sensors, which are typically in the form of a clip to be placed on the patient's finger and fixed by a spring. Elastic cushions support the optical elements and prevent slipping of the sensors off the finger.
- the existing disposable devices fail to provide homogeneous pressure applied to the finger. As a result, even pressurization of the finger tissue cannot be achieved. Furthermore, none of the existing devices can be used solely for the enhancement and quality improvement of blood-related signals, regardless of the measurement technique used for measuring these signals. For example, adhesive sensors are applicable to the pulse-oximetry technique based on the detection of optical signals, while being unsuitable for the impedance-based or the like technique.
- a disposable removable device for applying to a patient's extreme organ, the device comprising: a thin cover for wrapping at least a part of the extreme organ in a manner to provide under-systolic pressure on the tissue within said at least part of the organ, thereby providing even pressurization of the organ tissue which thus results in the enhancement and quality improvement of blood-related signal, at least a portion of the cover being made of a material enabling non-invasive measurements of the blood-related signal therethrough.
- the device is applied to the patient's finger.
- the cover is elastic and may itself be such as to press the finger tissue whilst wrapping the finger.
- the device may comprise a pneumatic device or a mechanical device, e.g., a pressing ring to be placed on the organ (e.g., finger) above the cover. By operating such a device, e.g., by twisting the ring, the desired pressure can be established.
- the device also provides a heating effect to heat the organ up to desired temperature (about 38°C), thereby enhancing the blood-related signal even more.
- the heating ability of the device increases the accuracy of the non-invasively derived blood-related parameters such as blood oxygen saturation, blood pressure, hemoglobin, glucose, cholesterol and other analyte concentrations.
- the shrinkage effect by heating the cover affects tissue pressurization.
- a disposable device for use with a measurement system capable of non-invasive measurements of blood-related signals, wherein the device is applicable to a patient's extreme organ and comprises a thin elastic cover for wrapping at least a part of the extreme organ in a manner to provide under systolic pressure on the tissue within said at least part of the organ, thereby providing even pressurization of the organ tissue which results in the enhancement of blood-related signal and improvement of its quality, at least a portion of the cover being made of a material enabling non-invasive measurements of the blood-related signal therethrough.
- a system for non-invasive measurements of blood-related signals comprising a measurement unit and a disposable device for applying to a patient's extreme organ, wherein said disposable device comprises a thin elastic cover for wrapping at least a part of the extreme organ in a manner to provide under systolic pressure on the tissue within said at least part of the organ, thereby providing even pressurization of the organ tissue which results in the enhancement of blood-related signal and improvement of its quality, at least a portion of the cover being made of a material enabling non-invasive measurements of the blood-related signal therethrough.
- a method for obtaining enhanced and quality improved blood-related signals within at least a part of a patient's extreme organ utilizing a thin cover for applying to said at least part of the organ, the method comprising the steps of: (a) providing said cover wrapping said at least part of the organ, at least a portion of the cover being made of a materials enabling non-invasive measurements of the blood-related signal therethrough; and (b) applying even pressurization to said at least part of the organ so as to provide under systolic pressure within a tissue of said at least part of the organ.
- a method for non-invasive measurements of at least one blood-related parameter within at least a part of a patient's extreme organ utilizing a device for enhancement and quality improvement of blood-related signals, the method comprising the steps of:
- the sensor means being capable of detecting said enhanced blood-related signals and generating data representative thereof;
- the sensor means may utilize an illumination assembly for illuminating at least the part of the organ with incident radiation, e.g., near infra-red (IR) radiation of 600-2000nm wavelength, and a detection assembly for detecting response of the illuminated part.
- incident radiation e.g., near infra-red (IR) radiation of 600-2000nm wavelength
- detection assembly for detecting response of the illuminated part.
- the location of the detection assembly depends on the kind of response that is to be detected, i.e., reflected or transmitted signal.
- the cover should be formed with means enabling light propagation therethrough.
- the entire cover may be transparent with respect to the incident radiation (e.g., near IR radiation).
- the cover should be of a sufficient thickness (i.e., preferably not exceeding 50 ⁇ m), so as to prevent the collection by the detection assembly of incident radiation rounding the wrapped organ, instead of signal response of the organ.
- the cover may be formed with at least one optical window transparent for near IR radiation, thereby enabling the application of the sensor means to a portion of the wrapped part of the organ below the window.
- two optical windows should be provided made at opposite sides of the cover. Should the reflected signal be detected by the sensor means, the provision of only one optical window is sufficient for measurements, but two spaced-apart optical windows located at the same side of the cover can be used.
- the non-transparent regions of the cover absorb light waves going around the cover' material thickness and through the skin of the wrapped organ, and prevent these waves from being collected by the detection assembly. This increases the signal-to-noise ratio of the detected signal.
- the non-transparent regions can be manufactured from the same material as that of the transparent regions, but with additional pigments such as carbon, titanium oxide, BaS, BaS0 4 , etc. that make these regions non-transparent for near
- IR radiation Materials suitable for the manufacture of the cover are silicon, latex and other flexible, elastic and transparent for near IR radiation materials.
- Figs, la and lb illustrate a device, constructed according to one embodiment of the invention, which is, respectively, in an inoperative position, prior to being applied to a patient's finger, and in an operative position being applied to the patient' s finger;
- Fig. 2a illustrates a device in an inoperative position thereof constructed according to another embodiment of the invention
- Figs. 2b and 2c illustrate two operational steps for applying the device of Fig. 2a to the patient's finger;
- Fig. 3a illustrates a device in an inoperative position thereof constructed according to yet another embodiment of the invention,;
- Figs. 3b and 3c illustrate two operational steps for applying the device of Fig. 3a to the patient's finger
- Figs. 4a to 4c illustrate one more embodiment of the present invention
- Figs. 5a to 5c graphically illustrate the main operational principles of the device of either of Figs, la-lb, 2a-2c, 3a-3c or 4a-4c, when being used with, respectively, optical-, impedance- and occlusion-based measurements
- Figs. 4a to 4c graphically illustrate the main operational principles of the device of either of Figs, la-lb, 2a-2c, 3a-3c or 4a-4c, when being used with, respectively, optical-, impedance- and occlusion-based measurements
- Fig. 6a to 6c schematically illustrate three more embodiments of a device according to the invention, DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
- the patient's finger constitutes an extreme organ to which a device for enhancing blood-related signals is applied.
- a device 2 associated with the patient's finger P and capable of enhancing blood-related signals within the finger.
- the device 2 comprises a cover 4, which is rolled up into a spherical-like segment when in an inoperative position of the device 2, i.e. prior to being applied to the finger P (Fig. la).
- the cover 4 is unrolled so as to wrap the patient's finger P (Fig. lb).
- the cover 4 is made of an elastic thin material, for example rubber, silicone, PVC, polyurethane, polyethylene, so as to be easily shifted from its normally inoperative, folded position into the operative, extracted position.
- the elastic cover slightly presses the tissue of the finger P.
- the elasticity of the cover and its small thickness provides slight, regular pressurization on the tissue, for example within a range 5-20 mm Hg, which is always less than the systolic blood pressure.
- This slight pressurization of the tissue causes the enhancement and quality improvement of the pulsatile and non-pulsatile blood-related signals within the wrapped portion of the finger P, and, on the other hand, prevents blood flow disturbance during future measurements.
- the cover 4 is made from such materials that do not affect any particular technique for measuring blood-related parameters. More specifically, for optical, acoustic and impedance-based measuring techniques, the material of the cover should allow for the penetration of, respectively, light, sound or electrical current into the tissue. For example, rubber, silicone, latex, PVC, nylon, paraffin, etc. can be used in the manufacture of the elastic cover.
- the pressuring elastic film-like cover may be formed by disposing quick drying glues such as Poly Vinil Alcohol, some resin solutions or the like, onto the finger. These materials, while drying, form a thin film coating on the finger.
- quick drying glues such as Poly Vinil Alcohol, some resin solutions or the like
- the device 2 also comprises a heating element 6 located above the extracted cover 4 wrapping the finger P.
- the heating element 6 is a conductive material connectable to a power source (not shown) that supplies sufficient voltage, for example in a range 1-6 V.
- the heating element 6 may be a separate constructional part to be applied to the finger P at a separate operational step, upon unrolling the cover 4 to wrap the finger.
- the heating element may be made of conductive silicone, conductive clothes, metal wire like NiCr, etc.
- the heating element may be attached to the cover, for example by making the heating element from sufficiently flexible material to allow for rolling/unrolling thereof together with the cover. Heating elements may be implanted into the cover.
- the material resistance of the cover itself, or the chemical exothermic reaction of two or more components (e.g., polyurethane) applied to the cover may be utilized.
- the pressuring film-like cover 4 provides the enhancement and quality improvement of the blood-related signals, while the heating element 6 enhances these signals even more, and increases the accuracy of blood-related parameters that are derived from the measured signals.
- any heating element is optional.
- the provision of the heating effect increases the accuracy of the non-invasively derived blood-related parameters, and, on the other hand, the shrinkage effect by heating the cover effects the tissue pressurization.
- These blood-related parameters are such as blood oxygen saturation, blood pressure, hemoglobin, glucose, cholesterol and other analytes concentration, etc.
- the device 20 comprises a cover 4, a heating element 6, and a flexible strap 8 (constituting a pressing assembly) capable of forming a ring on the finger above the cover, so as to attach the cover to the finger.
- the cover 4 is in the form of a thin flat film, which is shaped like a circle when in an inoperative position of the device 20.
- the heating element 6 is designed like a pair of spirals extending along two opposite regions of an outer surface of the film 4.
- the strap 8 may be made of a flexible wire, or may be a stretchable material, for example the same as that of the film.
- Figs. 2b and 2c more specifically illustrate the main operational steps for applying the device 20 to the patient's finger P to put the device in operation.
- the film cover 4 is stretched, thereby wrapping the finger P and extending the heating element 6 along the wrapped portion of the finger.
- the opposite ends of the strap 8 are fastened so as to form a ring 8 on the finger above the cover.
- the strap 8 is made of a flexible wire, its ends can be twisted together to fix the ring's diameter, thereby applying desired pressure to the finger tissue (Fig. 2d).
- Velcro-like fasteners or the like would be appropriately provided at the ends of the strap.
- any other suitable technique may be used for providing a ring-like support element 8 on the finger in a manner allowing for varying the ring's diameter.
- Figs. 3a-3c illustrate a device 30 for enhancement and quality improvement of blood-related signals within the finger P.
- the device 30 is generally similar to the devices 2 and 20, but has a somewhat different design.
- the cover 4 which is made of a high elastic material, is provided with a supporting ring 38 having a preset stretching force.
- the ring 38 may be made of a plastic material.
- the cover 4 is stretched up to a preset maximum value, it forces against the ring 38.
- the ring 38 tears off and can be removed from the finger.
- the desirably stretched cover 4 wraps the finger P whilst applying the desired even pressurization thereto.
- Figs. 4a illustrates a device 40 constructed according to yet another embodiment of the invention.
- the same reference numbers are used for identifying those components, which are identical in the device 40 and in the previously described examples.
- a cover 4 is made of a relatively low elastic material, and its periphery region is attached to a supporting twisting ring 48.
- a separate ring 48' made of a suitable material such that the ring 48' is hardly movable along the finger P as compared to the ring 48.
- the ring 48' may be formed with a slot, rather then being a closed loop, so as to adjust the diameter of the ring 48' and to facilitate its mounting on the finger, after attaching the cover 4.
- the ring 48 is inserted onto the finger P, thereby stretching the cover 4.
- the ring 48 is twisted, in a clockwise direction in Fig. 4c, while the ring 48 serves as a locking element preventing the movement of the ring 48 whilst being twisted.
- Figs. 5a-5c there are graphically illustrated the main operational principles of either of the above-described device when being used for, respectively, optical-, impedance- and occlusion-based measurements.
- Each of these figures illustrates two graphs, Gi and G 2 , corresponding to the time dependence of the measured blood-related signal R, respectively, before and after the application of the device.
- Gi and G 2 corresponding to the time dependence of the measured blood-related signal
- R the light intensity.
- R corresponds arbitrary units of impedance.
- the main principles of the optical- and impedance-based measurements do not form a part of the present invention and are known per se, and therefore need not be specifically described.
- the occlusion-based technique it also does not form a part of the present invention, and is the subject matter of the above-indicated Israel Patent Application No. 124965, which is a co-pending application, assigned to the assignee of the present application. This application is therefore incorporated herein by reference with respect to this specific example of one possible measurement technique for which the device according to the present invention is suitable.
- the main principles underlying the occlusion-based technique utilize the fact that light absorption characteristics of a blood perfuse medium dramatically changes when the character of the blood flow changes.
- occlusion-based measuring technique deals with non-volumetric blood-related signals.
- a cup-like cover 4 should be provided with means enabling optical measurements therethrough, based on the detection of either reflected or transmitted light response of the blood perfuse medium.
- the cover should be constructed so as to enable the light waves propagation therethrough. If the cover is substantially thin, i.e., practically not exceeding 50 ⁇ m, it can be entirely transparent for predetermined incident radiation, e.g. near IR radiation (600-2000nm), being made of silicon, latex, etc.
- Figs. 6a-6c illustrate three different examples, respectively, of a cup-like cover to be used in the disposable device according to the invention.
- the cover may be thicker than 50 ⁇ m, for example being of 0.5mm in thickness.
- the cover is illustrated here in its ready to be mounted on a patient's finger position, it should be understood that this position may be achieved by unrolling the cover.
- the cover 4 is formed with its upper and lower portion 50a and 50b made of a material transparent to near IR radiation (e.g., silicon or latex), and two opposite side portions 52a and 52b made of a material non-transparent (absorbing) to near IR radiation.
- a material transparent to near IR radiation e.g., silicon or latex
- two opposite side portions 52a and 52b made of a material non-transparent (absorbing) to near IR radiation.
- This may be achieved by manufacturing the entire cover from the same transparent material and forming its side portions 52a and 52b with additional pigments such as carbon, titanium oxide, BaS, BaS0 4 , etc.
- the provision of the opposite transparent portion 50a and 50b enables the use of such cover 4 with a transmission-based measurement unit. In other words, illumination and detection assemblies of the measurement unit should be associated with the portions 50a and 50b, respectively, or vice versa.
- the cover 4 is formed with two opposite optical windows 54a and 54b.
- the windows are made of a material transparent for near IR radiation, while all the other regions 55 of the cover, except for those occupied by the windows, are made of a material non-transparent for near IR radiation.
- This design of the cover is also suitable for use with a transmission-based measurement unit.
- the cover 4 is formed with a single optical window 56. This design is suitable to be used with a reflection-based measurement unit. As shown in the figure, for the purposes of the reflection-based measurement technique, an additional optical window 56' may be provided being located close to the window 56 at the same side of the cover. The windows 56 and 56' are spaced by a small non-transparent region.
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Abstract
Description
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Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU11764/00A AU1176400A (en) | 1999-03-09 | 1999-11-18 | A device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals |
US09/948,900 US6731963B2 (en) | 1999-03-09 | 2001-09-07 | Device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IL128903 | 1999-03-09 | ||
IL12890399A IL128903A0 (en) | 1999-03-09 | 1999-03-09 | Method and device for enhancement of blood related signal |
IL12979099A IL129790A0 (en) | 1999-03-09 | 1999-05-05 | A device for enhancement of blood-related signals |
IL129790 | 1999-05-05 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/948,900 Continuation-In-Part US6731963B2 (en) | 1999-03-09 | 2001-09-07 | Device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals |
Publications (1)
Publication Number | Publication Date |
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WO2000053080A1 true WO2000053080A1 (en) | 2000-09-14 |
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ID=26323802
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/IL1999/000621 WO2000053080A1 (en) | 1999-03-09 | 1999-11-18 | A device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals |
Country Status (4)
Country | Link |
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US (1) | US6731963B2 (en) |
AU (1) | AU1176400A (en) |
IL (1) | IL129790A0 (en) |
WO (1) | WO2000053080A1 (en) |
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Also Published As
Publication number | Publication date |
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IL129790A0 (en) | 2000-02-29 |
US6731963B2 (en) | 2004-05-04 |
AU1176400A (en) | 2000-09-28 |
US20020077535A1 (en) | 2002-06-20 |
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