WO1992015239A1 - Dispositif et procede de determination de la viscosite sanguine dans un etre vivant - Google Patents

Dispositif et procede de determination de la viscosite sanguine dans un etre vivant Download PDF

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Publication number
WO1992015239A1
WO1992015239A1 PCT/US1992/000194 US9200194W WO9215239A1 WO 1992015239 A1 WO1992015239 A1 WO 1992015239A1 US 9200194 W US9200194 W US 9200194W WO 9215239 A1 WO9215239 A1 WO 9215239A1
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WO
WIPO (PCT)
Prior art keywords
blood
vessel
viscosity
determining
sampling
Prior art date
Application number
PCT/US1992/000194
Other languages
English (en)
Inventor
Young Cho
Kenneth Kensey
Original Assignee
Kensey Nash Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kensey Nash Corporation filed Critical Kensey Nash Corporation
Publication of WO1992015239A1 publication Critical patent/WO1992015239A1/fr

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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
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • A61B5/02035—Determining blood viscosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0275—Measuring blood flow using tracers, e.g. dye dilution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • 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
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • 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
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel

Definitions

  • This invention relates generally to medical instruments for and methods of determining the viscosity of the blood of a living being.
  • the apparatus basically comprises sampling means arranged to be coupled to a blood vessel of the being for monitoring a portion of the being's blood at substantially the time that that portion of the blood is flowing through the blood vessel to determine its viscosity.
  • the sampling means comprises a monitor unit arranged to be disposed within the blood vessel and comprising first means, e.g., a pair of solid state transducers, for determining a pressure differen ⁇ tial between two longitudinally spaced apart points in the vessel, and second means, e.g., another pair of solid state transducers, for determining the flow rate of said portion of the blood flowing through the vessel adjacent those points.
  • the second means may take various forms, e.g., heating means for heating a first portion of the blood portion at a first (upstream) location within the vessel and sensing means located downstream of the heating means for sensing the temperature of that first portion of blood flowing thereby so that the flow rate can be determined.
  • the sampling means comprises penetration means, e.g., a needle, arranged to be inserted within the vessel and body means coupled to the penetration means.
  • the body means is arranged to be disposed outside of the being's body to receive the portion of the blood flowing through the penetration means.
  • the body means includes first means, e.g., at least one pair of solid state transducers, for determining a pressure differential between two longitudinally spaced apart points in the body means, and second means, e.g., a controllable displacement device, for establishing a flow rate of the blood through the body means so that the blood viscosity can be determined.
  • Calculation means are also provided for calculating the blood's viscosity based on data developed from the first and second means.
  • Fig. 1 is a sectional view, partially schematic, showing an implantable embodiment of apparatus constructed in accordance with this invention for effecting in-vivo measure ⁇ ment of blood viscosity;
  • Fig. 2 is an enlarged sectional view taken along line 2 - 2 of Fig. 1;
  • Fig. 3 is a view similar to that of Fig. 1 but showing an alternative embodiment of apparatus constructed in accordance with this invention;
  • Fig. 4 is an enlarged sectional view taken along line 4 - 4 of Fig. 3;
  • Fig. 5 is an enlarged sectional view taken along line 5 - 5 of Fig. 3
  • the apparatus 20 is arranged for effecting the in-vivo measure ⁇ ment of the viscosity of the blood of a living being and basically comprises a pair of components, namely, an implantable monitor unit 22, and an associated externally located control/ nalysis unit 24.
  • the monitor unit 22 will be described in detail later. Suffice it for now to state that it is arranged to be implanted within a suitable blood vessel 26 of the being.
  • the monitor unit includes electrical leads, to be described later, connecting it to the control/analysis unit 24. That unit is arranged to be located outside the body of the being and serves to provide electrical signals to the monitor unit and to receive electrical signals therefrom.
  • the control/ analysis unit uses signals from the monitor unit to calculate the viscosity of the blood. In particular the blood viscos ⁇ ity is readily calculated by the control/analysis unit 24 using software in it, without requiring manual interaction.
  • the monitor unit 22 basically comprises a small diameter, e.g., 8 or 9 mm outside diameter, tube 28 formed of any material, e.g., stainless steel, suitable for location within the interior 30 of the being's blood vessel 26.
  • the tube is preferably of very thin wall thickness, e.g., 0.5 mm, and its upstream end 32 is tapered so that blood can flow readily into its interior without interference by that end of the tube.
  • a pair of solid state, e.g., piezoelectric crystal, pressure transducers 34 and 36 are located within the side- wall of the tube 28 and are flush with the inner surface thereof. The transducers are longitudinally spaced from each other by a fixed, predetermined distance L, e.g., 2 cm.
  • Each transducer is electrically coupled, via an associated conduc ⁇ tor 38, to the external control/analysis unit 24 to provide signals indicative of the drop in the pressure of the blood in the distance L between the two transducers.
  • signals are provided to a computer and signal processor 40 forming a portion of the control/analysis unit 24.
  • the computer and signal processor 40 can be of any suitable construction, e.g., a microprocessor and associated storage means, having software in it to effect the calcula ⁇ tion of the viscosity from the electrical signals provided to it.
  • Those signals constitute the pressure drop signals pro ⁇ vided from the transducers 34 and 36, as well as electrical signals indicative of the instantaneous velocity of the blood adjacent the transducers and the other parameters (to be described later) .
  • the signals indicative of the instantaneous velocity of the blood flowing through the tube 28 adjacent the transducers is provided by velocity sensing probe means 42 in the unit 22 and an associated velocity probe controller 44 located in the external unit 24.
  • the velocity sensing probe means 42 basically comprises a pair of electrical resistance heating probes 46 and 48 projecting a short distance, e.g., 2 mm, radially inward into the interior of the tube 28 from the inner surface thereof.
  • the probes are longitudinally spaced apart from each other by a predeter ⁇ mined distance, e.g. , 2 cm.
  • Each of the probes is connected via a pair of conductors 50 and 52 (although only one of each is shown in the interest of drawing simplicity) to the probe velocity controller 44.
  • the probe velocity controller provides an electrical signal via conductors 50 to the upstram probe 46 to cause that probe to heat up quickly and thereby produce a heat pulse in the portion of the blood flowing thereby.
  • the propagation of the heat pulse to the downstream probe 48 resulting from the flow of the heated blood portion thereby is sensed by that probe and a signal indicative thereof is provided via conductors 52 to the probe velocity controller 44.
  • the controller 44 measures the delay or propagation time for the heat pulse produced in the blood by the upstream probe to reach the downstream probe and provides output signals via lines 54 to the computer and signal processor 40 to enable the instantaneous velocity of the blood, V, to be calculated thereby.
  • the computer and signal processor 40 has stored therein data representing the distance separating the probes 46 and 48. From the instan ⁇ taneous blood velocity, V, the computer and signal processor calculates the instantaneous flow rate, Q of the blood. To achieve that end the computer and signal processor 40 also has stored therein data representing the value of inner diameter D of the tube 28.
  • the instantaneous flow rate, Q is calculated by the following formula: ⁇ VD 2
  • the computer and signal processor 40 also has stored therein data representing the value of the distance L separating the transducers 34 and 36. That data, together with the calculated instantaneous flow rate Q of the blood enables the computer and signal processor 40 to calculate the instantaneous viscosity of the blood.
  • the instantaneous blood viscosity, ⁇ is calculated by the computer and signal processor 40 in accordance with the following formula, where D, *P is the pressure drop between transducers 34 and 36, L is the distance between the trans ⁇ ducers, and Q is the instantaneous blood volume flow rate:
  • Fig. 2 there is shown an alternative embodiment 100 of the subject invention.
  • the apparatus does not include any implantable component for disposition within a blood vessel to effect the determination of the blood's viscosity by monitoring it as it flows naturally under the impetus of the heart's contractions.
  • the apparatus 100 effects the withdrawal of blood from the body of the being at a controlled rate and determines the blood's viscosity as it is being withdrawn.
  • blood is a non-newtonian liquid, i.e., its viscosity varies with its shear rate. Accordingly, since the apparatus 100 does not calculate the blood's viscosity as it naturally flows through the being's blood vessel, the apparatus 100 is arranged to calculate the blood's viscosity at various shear rates to provide a more accurate representation of its value than if it was calculated based on only a single shear rate. Shear rate is the ratio of flow velocity to vessel diameter.
  • the viscosity of the blood is calcu ⁇ lated by the apparatus 100 within a very short period of time, e.g., from a few milliseconds to a second or two, after it has been withdrawn from the blood vessel. Accordingly, it can be said that the apparatus 100 provides the determination of the blood's viscosity at substantially the same time that it is flowing through the being's body and without the blood having time to cool or be exposed to air.
  • the apparatus 100 basic ⁇ ally comprises a sampling unit 102 and an associated control/ analysis unit 104.
  • the control/analysis 104 unit is similar to unit 24 in that it serves to provide electrical signals to the sampling unit 102 and to receive electrical signals therefrom. These signals are used by the control/analysis unit 104 to calculate the viscosity of the blood.
  • the control/analysis unit 104 includes the heretofore identified and described computer and signal processor 40 and associated software utilizing the data and formulae discussed above.
  • the control/analysis unit 104 includes a flow rate controller 106 (to be described later) .
  • the sampling unit 102 basically comprises a syringe-like body 108 having a hypodermic needle 110 located at its free end.
  • the needle 110 in arranged to be inserted through the skin of the being into the interior of his/her blood vessel 26 and the apparatus operated (as will be described later) to withdraw blood at a controlled rate from the vessel into the syringe-like body to provide signals indicative of flow rates and pressure drops in portions of the syringe-like body from which signals the control/analysis unit 104 calculates the viscosity of the blood.
  • the syringe-like body 108 includes a hollow rear portion 112, formed of any suitable material (e.g., glass) of relatively large inside diameter, e.g., 1.5 cm, and in which a moveable piston 114 is disposed.
  • the front of the body is in the form of a pair of axially aligned, thin walled, tubes 116 and 118 which are in fluid communication with each other, with the hypodermic needle 110, and with the interior of the body portion 112.
  • the tubes are secured to each other, the tube 118 secured to the body portion 112, and the hypodermic needle secured to the front of the tube 116.
  • each of the tubes 116 and 118 forms a respective passageway through which the blood withdrawn by the apparatus 100 passes to enable its flow rate to be determined therein.
  • the tube 116 is of smaller inner diameter than the tube 118 so that the flow rate through tube 116 will be greater than through tube 118.
  • the tube 116 has an inner diameter of from 2-3 mm and a length of 2 cm, while the tube 118 has an inner diameter of from 4-6 and a length of 3 cm.
  • the tubes are formed of any suitable material, e.g., stainless steel.
  • the blood is caused to enter the apparatus 100 by the rearward movement of the piston 114 within the syringe body 112.
  • the rate at which the piston is moved rearwardly within the body 112 is constant and is established by driver means (to be described later) either under manual or computer control.
  • driver means to be described later
  • the withdrawn blood will flow at different rates through the tubes 116 and 118, with the flow rate through the smaller diameter tube 116 being faster than the rate through the larger diameter tube 118.
  • a first pair of solid state, e.g., piezoelectric crystal, pressure transducers 120 and 122 are located within respective holes in the sidewall of the tube 116 so that they are flush with the inner surface thereof.
  • the transducers are longitudinally spaced from each other by a fixed, predetermined distance, L, e.g., 1.5 cm.
  • L e.g. 1.5 cm.
  • Each transducer is electrically coupled, via an associated conductor 124, to the computer and signal processor 40 in a manner like that described above to provide signals indicative of the drop in the pressure of the blood in the distance L between the two transducers as blood is withdrawn by the apparatus 100.
  • a second pair of solid state, e.g., piezoelectric crystal, pressure transducers 126 and 128 are located within respec ⁇ tive holes in the sidewall of the tube 118 so that they are flush with the inner surface thereof. These transducers are also longitudinally spaced from each other by the fixed, predetermined distance L. Moreover, each transducer is electrically coupled, via an associated conductor 130, to the computer and signal processor in a manner like that described above to provide signals indicative of the drop in the pressure of the blood in the distance L between the two transducers as blood is withdrawn by the apparatus 100.
  • solid state e.g., piezoelectric crystal
  • the means for driving the piston 114 basically comprise a driver motor and an associated rack and pinion assembly 132. Signals to control the speed of operation of the drive motor and rack and pinon assembly are provided from the flow rate controller 106.
  • the flow rate controller also provides signals indicative of the blood flow rate Q estab ⁇ lished by it to the computer and signal processor 40 so that the viscosity of the blood may be calculated in accordance with the formula described above.
  • the piston is operated at one of three different speeds in accordance with signals provided by the flow rate controller. These signals are established by either manual input 132 to the controller or by signals from the computer and signal processor 40. Thus, for each speed of movement of the piston two blood flow rates through the apparatus 100 are established. This feature enables the apparatus to calculate the viscosity of the blood at six flow rates (thus, at six shear rates) by merely changing the speed at which the piston is driven.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Physiology (AREA)
  • Vascular Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Dispositif (20) servant à déterminer la viscosité du sang entier d'un être vivant et composé d'une unité de contrôle (22) conçue pour s'accoupler à un vaisseau sanguin (26), afin de contrôler la durée du transit d'une partie du sang quand il s'écoule dans ledit vaisseau. Dans l'un des modes de réalisation de l'invention, l'unité d'échantillonnage (22) est implantable dans le vaisseau sanguin (26) et utilise une paire de transducteurs (34, 36) pour mesurer une chute de pression à l'intérieur du vaisseau, un dispositif (42) servant à déterminer la vitesse de la circulation sanguine instantanée dans ledit vaisseau, ainsi qu'un circuit (24) servant à calculer la viscosité sanguine. Dans un autre mode de réalisation, une unité d'échantillonnage comprend une aiguille (110) et un élément associé analogue à une seringue (108), plusieurs paires de transducteurs de pression (120-122 et 126-128) et un circuit de calcul associé (40) pour déterminer la chute de pression à des débits différents, de façon à calculer la viscosité du sang.
PCT/US1992/000194 1991-02-04 1992-01-13 Dispositif et procede de determination de la viscosite sanguine dans un etre vivant WO1992015239A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US66426291A 1991-02-04 1991-02-04
US664,262 1991-03-04

Publications (1)

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WO1992015239A1 true WO1992015239A1 (fr) 1992-09-17

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WO (1) WO1992015239A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5785657A (en) * 1994-01-14 1998-07-28 Pacesetter Ab Blood flow measurement device
WO2005006975A1 (fr) * 2003-07-18 2005-01-27 Ventracor Limited Dispositif et systeme de mesure de la pression arterielle
WO2009014558A1 (fr) * 2007-07-23 2009-01-29 Cardiac Pacemakers, Inc. Dispositif de surveillance de viscosité implantable et procédé associé
US7798952B2 (en) 2003-10-09 2010-09-21 Thoratec Corporation Axial flow blood pump
US8449444B2 (en) 2009-02-27 2013-05-28 Thoratec Corporation Blood flow meter
US8562507B2 (en) 2009-02-27 2013-10-22 Thoratec Corporation Prevention of aortic valve fusion
US9757502B2 (en) 2010-09-24 2017-09-12 Tci Llc Control of circulatory assist systems
US9801988B2 (en) 2010-09-24 2017-10-31 Tc1 Llc Generating artificial pulse
WO2019234167A1 (fr) * 2018-06-06 2019-12-12 Kardion Gmbh Dispositif de détermination et procédé pour déterminer la viscosité d'un fluide

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2345716A1 (fr) * 1976-03-27 1977-10-21 Weber Gerhard Procede pour determiner dans un but medical ou pharmaceutique le comportement rheologique de liquides, et appareil pour la mise en oeuvre du procede
EP0126931A2 (fr) * 1983-04-21 1984-12-05 The Board Of Trustees Of The Leland Stanford Junior University Méthode et appareil pour la mesure de débit
US4621646A (en) * 1983-12-15 1986-11-11 The United States Of America As Represented By The Secretary Of The Army Blood flow measuring method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2345716A1 (fr) * 1976-03-27 1977-10-21 Weber Gerhard Procede pour determiner dans un but medical ou pharmaceutique le comportement rheologique de liquides, et appareil pour la mise en oeuvre du procede
EP0126931A2 (fr) * 1983-04-21 1984-12-05 The Board Of Trustees Of The Leland Stanford Junior University Méthode et appareil pour la mesure de débit
US4621646A (en) * 1983-12-15 1986-11-11 The United States Of America As Represented By The Secretary Of The Army Blood flow measuring method

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5785657A (en) * 1994-01-14 1998-07-28 Pacesetter Ab Blood flow measurement device
WO2005006975A1 (fr) * 2003-07-18 2005-01-27 Ventracor Limited Dispositif et systeme de mesure de la pression arterielle
US7798952B2 (en) 2003-10-09 2010-09-21 Thoratec Corporation Axial flow blood pump
US8366599B2 (en) 2003-10-09 2013-02-05 Thoratec Corporation Axial flow blood pump
WO2009014558A1 (fr) * 2007-07-23 2009-01-29 Cardiac Pacemakers, Inc. Dispositif de surveillance de viscosité implantable et procédé associé
US10376622B2 (en) 2009-02-27 2019-08-13 Tc1 Llc Prevention of aortic valve fusion
US8449444B2 (en) 2009-02-27 2013-05-28 Thoratec Corporation Blood flow meter
US8562507B2 (en) 2009-02-27 2013-10-22 Thoratec Corporation Prevention of aortic valve fusion
US8715151B2 (en) 2009-02-27 2014-05-06 Thoratec Corporation Blood flow meter
US9687596B2 (en) 2009-02-27 2017-06-27 Tci Llc Prevention of aortic valve fusion
US11648386B2 (en) 2009-02-27 2023-05-16 Tc1 Llc Prevention of aortic valve fusion
US10046098B2 (en) 2009-02-27 2018-08-14 Tc1 Llc Prevention of aortic valve fusion
US9801988B2 (en) 2010-09-24 2017-10-31 Tc1 Llc Generating artificial pulse
US10086122B2 (en) 2010-09-24 2018-10-02 Tc1 Llc Generating artificial pulse
US10881772B2 (en) 2010-09-24 2021-01-05 Tc1 Llc Generating artificial pulse
US9757502B2 (en) 2010-09-24 2017-09-12 Tci Llc Control of circulatory assist systems
US11944799B2 (en) 2010-09-24 2024-04-02 Tc1 Llc Generating artificial pulse
WO2019234167A1 (fr) * 2018-06-06 2019-12-12 Kardion Gmbh Dispositif de détermination et procédé pour déterminer la viscosité d'un fluide
CN112584759A (zh) * 2018-06-06 2021-03-30 开迪恩有限公司 用于确定流体的粘度的确定器具及方法
CN112584759B (zh) * 2018-06-06 2024-03-29 开迪恩有限公司 用于确定流体的粘度的确定器具及方法

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Publication number Publication date
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