US3650277A - Apparatus for influencing the systemic blood pressure in a patient by carotid sinus nerve stimulation - Google Patents

Apparatus for influencing the systemic blood pressure in a patient by carotid sinus nerve stimulation Download PDF

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US3650277A
US3650277A US12062A US3650277DA US3650277A US 3650277 A US3650277 A US 3650277A US 12062 A US12062 A US 12062A US 3650277D A US3650277D A US 3650277DA US 3650277 A US3650277 A US 3650277A
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signal
blood pressure
output signal
pulse
output
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Ulf Hakan Sjostrand
Per Ake Oberg
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LKB MEDICAL AB
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LKB MEDICAL AB
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36564—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by blood pressure
    • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7239—Details of waveform analysis using differentiation including higher order derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36114—Cardiac control, e.g. by vagal stimulation
    • A61N1/36117—Cardiac control, e.g. by vagal stimulation for treating hypertension

Definitions

  • ABSTRACT A system for reducing and controlling the blood pressure of a hypertensive patient has electrical pulse stimulation of the carotid-sinus nerves controlled by the arterial blood pressure of the patient in such a manner that the number of stimulation pulses within each heart cycle is determined by the arterial means blood pressure whereas the distribution of stimulation pulses over the heart cycle is a function of the arterial pulse wave shape with the pulse frequency being greater during the first portion of the heart cycle.
  • the present invention is related to an apparatus for influencing the systemic blood pressure in human beings and more particularly for reducing and controlling the blood pressure in hypertensive patients.
  • FIG. 1 in the enclosed drawing illustrates a lay-out of this control system.
  • the arterial systemic blood pressure is sensed by baroreceptors 2 in the body, which can be regarded as pressure-signal-transducers to convey information on the actual arterial blood pressure through afferent nerve paths to the vasomotor center 3.
  • Baroreceptors 2 in the body can be regarded as pressure-signal-transducers to convey information on the actual arterial blood pressure through afferent nerve paths to the vasomotor center 3.
  • Man has several such baroreceptor areas, the most important ones being located at the aorta arch and in the two carotid-sinus regions.
  • these baroreceptors may be regarded as parameter sensors conveying information to the vasomotor center of the actual arterial blood pressure.
  • the vasomotor center can be regarded as a comparator and regulator which compares the information about the actual blood pressure received from the baroreceptors with information about the desired blood pressure received from other cardio-vascular centers and other receptors in the body and which in response to this comparison influences those effector systems 4 in the body directly determining the systemic arterial blood pressure.
  • effectors are primarily the heart, the volume rate of which is an important factor determining the systemic blood pressure, and the peripheral-vascular system, in particular the arterial system but also the venous system, the contraction and dilation of which affect the blood pressure.
  • the object of the present invention is therefore to provide an improved apparatus for influencing the blood pressure in a patient, in particular for reducing the blood pressure of a hypertensive patient, by electrical stimulation of afferent nerve paths from the baroreceptors of the patient, in particular the sinus nerves from the carotid-sinus areas.
  • the device according to the invention comprises as already suggested in the prior art an electrode or stimulator assembly which can be applied on or close to an afferent nerve for stimulation thereof with short electric pulses and a pulse generator connected to said stimulator assembly for supplying stimulating pulses thereto.
  • a pulse generator connected to said stimulator assembly for supplying stimulating pulses thereto.
  • the pulse generator is provided with two pulse outputs connected to said two stimulator assemblies respectively.
  • the device according to the invention is characterized in that it comprises a signal generator for producing a control signal for the pulse generator dependent on the. heart activity of the patient and that the pulse generator produces in response to said control signal during each heart cycle a pulse series of limited length, which starts at the beginning of the heart cycle and in which the majority of pulses appear during the first portion of the heart cycle.
  • the device according to the invention satisfies two essential conditions for a true-to-nature stimulation of the afferent nerve activity on the sinus nerves, namely on the one hand that the stimulation is synchronized to the heart activity of the patient and consists of a limited pulse series during each heart cycle and on the other hand that this pulse series has the majority of its pulses concentrated to the first portion of the heart cycle.
  • the signal generator responsive to the heart activity of the patient may consist of a pressure transducer which is connected to an artery of the patient and produces an electric output signal substantially representing the instantaneous arterial blood pressure of the patient.
  • a pressure transducer may for instance consist of a strain gauge device coupled to the artery through a catheter inserted therein. It is also possible to mount the pressure transducer externally on the artery so as to be affected by the stresses in the wall of the vessel, which stresses are dependent on the blood pressure in the vessel. It is of course also possible to use other types of pressure sensitive electrical transducers, as for instance piezoelectric crystals.
  • the electric output signal which is obtained from the pressure transducer and which varies with the instantaneous arterial blood pressure of the patient is supplied to signal transforming circuits which produce a first signal representative of the arterial mean blood pressure of the patient and a second signal representative of the derivative or rate of change of the arterial blood pressure of the patient and which sum said first and second signals and produces a signal corresponding to said sum, said last-mentioned signal being connected to the pulse generator as a control signal therefor and the pulse generator being adapted to produce pulses having a pulse frequency corresponding to the amplitude of the control signal supplied to the generator.
  • a stimulation is obtained which is synchronized with the heart activity of the patient in that a limited pulse series is produced during each arterial pulse cycle so as to start at the beginning of the pulse cycle.
  • each such pulse series will contain a number of pulses determined by the prevailing arterial means blood pressure and display a pulse frequency modulation determined by the shape of the arterial pulse wave during the current pulse cycle.
  • the arterial pulse wave has a large positive derivative of comparatively short duration at the beginning of the pulse cycle and thereafter during the remaining, substantially longer portion of the pulse cycle a smaller negative derivative
  • each pulse series will display a pulse frequency which after an initial and rapid increase in pulse frequency decreases continuously from its maximum value at the beginning of the pulse series.
  • the artificially stimulated nerve activity will duplicate the natural biological nerve activity from the baroreceptors with a much higher fidelity.
  • the artificial stimulation of the nerve activity is dependent on the mean blood pressure of the patient as well as the derivative of the blood pressure, that is the shape of the arterial pulse wave, the device according to the invention will form an integral part of the natural biological blood pressure regulator system.
  • the device. according to the invention can be regarded as a parameter sensor which supplements the natural biological parameter sensors in the blood pressure regulatory system formed by the baroreceptors of the patient.
  • HO. 1 is the schematic and very simplified block diagram described in the foregoing for the natural biological blood pressure regulator system
  • FIG. 2 shows by way of example the block diagram for an embodiment of a device according to the invention, in which the artificial stimulation of the nerve activity is dependent on the arterial mean blood pressure as well as the derivative of the arterial blood pressure;
  • FIG. 3 is a diagram schematically illustrating the natural afferent nerve activity from a baroreceptor during an arterial pulse cycle for different arterial mean blood pressures
  • FIG. 4 is a diagram of the mean pulse frequency of the stimulating pulses as a function of the mean pressure for the device according to the invention illustrated in FIG. 2;
  • H6. 5 is a diagram illustrating schematically the pulse series produced by the device according to the invention illustrated in FIG. 2 for a sinusoidally varying pressure and for different settings of the device;
  • FIG. 6 shows a number of blood pressure curves illustrating the blood pressure regulation obtained in experiments on dogs with a device according to FIG. 2 as compared with the blood pressure regulation caused by the natural baroreceptors in the carotid-sinus areas.
  • curve A illustrates schematically the shape of the normal arterial pulse wave during an arterial pulse cycle
  • curve B illustrates the corresponding ECG-signal
  • the diagrams C, D, E, F and G respectively illustrate the nature of the afferent nerve activity on the sinus nerve during the heart pulse cycle for different arterial mean blood pressures. As illustrated by these diagrams this nerve activity consists of pulse series.
  • a characteristic property of this nerve activity is that it is synchronized with the arterial pulse cycle so that the nerve activity consists of a pulse series for each arterial pulse cycle starting at the beginning of the arterial pulse cycle and having its pulses primarily concentrated in the first portion of the arterial pulse cycle.
  • the number of pulses in each pulse series is dependent on the arterial mean blood pressure in such a manner that the number of pulses increases with increasing arterial mean blood pressure.
  • Another characteristic property of the afferent pressure responsive nerve activity is that each pulse series is modulated with respect to its pulse frequency, generally speaking in such a manner that the pulse frequency decreases continuously during the duration of the pulse series from a maximum frequency at the beginning of the pulse series.
  • a device for electrical stimulation of the afferent nerve activity for instance on the sinus nerve, in order to influence the blood pressure the aim must consequently be to compose this stimulation in such a manner that it copies or resembles as closely as possible the natural nerve activity illustrated in FIG. 3 and described above.
  • the device according to the invention may in the most simple case comprise a pulse generator having a pulse output connected to a stimulator or electrode assembly applied on or close to a selected nerve or nerves and designed to produce in response to a starting signal a pulse series having a predetermined number of pulses and a predetermined pulse frequency.
  • a pulse generator having a pulse output connected to a stimulator or electrode assembly applied on or close to a selected nerve or nerves and designed to produce in response to a starting signal a pulse series having a predetermined number of pulses and a predetermined pulse frequency.
  • the pulse generator is designed to start a pulse series in response to the readily detectable R-wave in the ECG- signal at the beginning of each a heart cycle.
  • the pulse frequency and possibly also the'pulse frequency modulation of the pulse series produced by the pulse generator to the natural biological regulatory response of the patient in question it is possible to achieve a desired reduction of the blood pressure level of the patient.
  • the artificial stimulation of the nerve activity will not adapt itself automatically to the prevailing arterial mean blood pressure of the patient as the natural nerve activity does (F IG. 3) and neither will it be affected by any variations in the shape of the arterial pulse wave.
  • F IG. 3 the natural nerve activity
  • FIG. 2 illustrates the fundamental block diagram for such a more sophisticated device according to the invention.
  • This device includes two identical electrode or stimulator assemblies 5 and 6 adapted to be applied on or close to the sinus nerves of the patient for electrical stimulation of the nerve activity therein.
  • Each such stimulator or electrode assembly may for instance include two loop-shaped electrodes arranged to enclose the nerve at spaced positions. Also other types and locations of the stimulator assemblies may of course be used.
  • the two stimulator assemblies 5 and 6 are connected to separate pulse outputs from a controlled pulse generator 7 of any suitable design, which on its two outputs produces pulses having a pulse frequency determined by a control signal, as for instance a direct voltage signal, applied to the control input of the pulse generator.
  • the two stimulators 5 and 6 are supplied with identical pulse series from the pulse generator 7.
  • the one output of the pulse generator is provided with a delay circuit 15 so that the pulse series on this output is delayed relative to the pulse series on the other output by a delay time which is shorter than the shortest interval between two successive pulses in the pulse series. In this way cross-stimulation between the two stimulators 5 and 6, that is between the left side and the right side of the patient, is prevented.
  • the device includes also a pressure transducer 8 of suitable type, which can be connected or applied to an artery of the patient and which produces an electric output signal which is substantially proportional to the instantaneous arterial blood pressure of the patient.
  • such a pressure sensitive signal transducer may consist of a strain gauge transducer which is connected to the artery through a catheter inserted into the artery or is mounted externally on the artery so as to be affected by the mechanical stresses in the wall of the artery.
  • the output signal from the pressure transducer 8, representing the instantaneous arterial blood pressure is through an amplifier 9 supplied to two signal transforming circuits l0 and 11.
  • the circuit 10 is designed to calculate on the basis of the input signal the arterial mean blood pressure and to produce an output signal proportional thereto.
  • the calculation of the arterial mean blood pressure may be carried out in various manners.
  • the circuit 10 may consists of a mean value rectifying circuit having a suitable time constant.
  • the circuit 10 includes two peak detecting amplifiers which are connected to the signal from the pressure transducer 8 with opposite polarities so that the one amplifier produces an output signal representing the systolic blood pressure, whereas the other amplifier produces an output signal representing the diastolic blood pressure.
  • the second signal transforming circuit 11 is a differentiating circuit which produces an output signal having an amplitude proportional to the derivative or rate of change of the arterial blood pressure and a polarity corresponding to the sign of this derivative.
  • the output signal from the differentiating circuit 1] is supplied through a variable circuit element 14, for instance a potentiometer, to the second input of the signal adding amplifier 13.
  • a variable circuit element 14 for instance a potentiometer
  • the signal adding amplifier I3 sums the two input signals and produces an output signal proportional to the sum. This output signal is connected to the pulse generator 7 as a control signal therefor.
  • the pulse generator 7 is designed to have a lower threshold level for the input signal below which threshold value no pulses are generated.
  • This lower threshold level for the input signal corresponds preferably to a constant non-varying blood pressure of about 40-50 mm. Hg.
  • the pulse generator has preferably an upper saturation frequency of for instance about 300 Hz., which is reached for an input signal corresponding to a constant non-varying blood pressure of for instance about 250-300 mm. Hg.
  • the pulse series generated by the pulse generator 7 will have a mean pulse frequency determined by the magnitude of the calculated arterial mean blood pressure and the setting of the potentiometer l2 and a pulse frequency modulation determined by the derivative of the arterial blood pressure, that is the shape of the arterial pulse wave, and the setting of the potentiometer 14.
  • FIG. 4 is a diagram illustrating the relationship between the mean pulse frequency of the pulse series produced by the pulse generator 7 and the mean pressure sensed by the pressure transducer 8 for a pressure which varies sinusoidally about the mean pressure with the frequency 2 Hz.
  • This relationship is substantially linear and substantially independent of the setting of the potentiometer 14, that is of the magnitude of the component of the control signal for the pulse generator 7 corresponding to the derivative of the pressure. This is also what one would expect, as for a signal varying periodically about a constant value, the time integral of the positive derivative of the signal is always equal to the time integral of the negative derivative of the signal.
  • the diagrams H, J and K illustrate the pulse series produced by the pulse generator 7 for different settings of the potentiometer 14, when the pressure transducer 8 is affected by a pressure which varies sinusoidally about a given mean pressure with the frequency 2 Hz. as illustrated by the curve L.
  • the pulse series illustrated by the diagram H is obtained when the potentiometer 14 has such a setting that the signal supplied to the signal adding amplifier 13 from the differentiating circuit 11 is zero, that is when the pulse generator 7 is controlled only by the signal representing the mean pressure from the circuit 10.
  • a constant pulse frequency the magnitude of which is determined by the mean pressure.
  • the diagrams J and K respectively illustrate pulse series obtained when the potentiometer 14 has such a setting that a certain signal proportional to the derivative of the pressure is supplied from the circuit 11 to the adder amplifier 13, this derivative representing signal component being larger in the case illustrated by the curve K than in the case illustrated by the diagram J.
  • these two pulse series contain substantially the same number of pulses during each period of the varying pressure (curve L), whereas the pulses are distributed differentially over the period dependent on the relative magnitude of the derivative representing signal component from the circuit 11.
  • the experiments were carried out in the following manner: The two carotid-sinus regions of the animal were dissected free.
  • the common carotid artery on each side was provided with a device by means of which the artery could be clamped for a desired time interval and thereafter reopened.
  • On each side of a catheter was inserted into the carotid-sinus and fixed by a ligature as close as possible to the bifurcation between the external and the internal carotid arteries.
  • These two catheters were connected through polyethene catheters and a valve to a catheter inserted into the femoral vein. By means of the valve it was possible to open or close the communication between the two sinuses and the femoral vein.
  • the sinus nerves from the carotid-sinus areas were also dissected free and on these nerves the two stimulators 5 and 6 of the device according to the invention (FIG. 2) were applied near to the origin of the nerves in the sinuses.
  • the pressure transducer 8 of the device according to the invention (FIG. 2) was connected to a catheter inserted in the femoral artery.
  • the output signal from the pressure transducer 8 was connected not only to the two signal transforming circuits l0 and 11 in the device according to the invention but also to a recorder for recording the arterial blood pressure of the animal during the experiment.
  • the experiments show that it is essential that the artificial stimulation of the afferent nerve activity has a pulse frequency which is modulated in such a way, preferably in dependence of the derivative of the arterial blood pressure,
  • the stimulation was made with square wave pulses having an amplitude of 2 v. and a pulse length of 0.1 msec.
  • the pulse amplitude as well as the pulse length must be adjusted to the actual design of the stimulator assemblies and their location relative to the nerves to be stimulated so that the desired nerve activity is achieved in the nerves.
  • a pulse amplitude within the range l-5 v. and a pulse length within the range 0.1-2 msec. should be suitable.
  • the two stimulator assemblies and the pressure transducer sensing the arterial blood pressure may be permanently implanted in the body and connected through wire conductors to a unit located outside the said external unit including the pulse generator, the signal transforming circuits and the necessary power source.
  • the stimulator assemblies and the pressure transducer may be coupled inductively to said external unit. It is also possible to miniaturize the device so that the complete device can be subcutaneously implanted, in which case it is preferably provided with inductively rechargeable batteries so that the device does not have to be removed for replacement of the batteries.
  • pressure sensitive transducer means adapted to be connected to the arterial system of the individual for sensing the arterial blood pressure and producing an electric output signal substantially representing the instantaneous arterial blood pressure in the individual;
  • signal transforming means receiving the transducer output signal and including (a) a first signal transforming circuit providing an output signal substantially proportional to the mean value of the transducer output signal, and (b) a second signal transforming circuit providing an output signal whose amplitude is proportional to the derivative of the transducer output signal and whose polarity corresponds to the algebraic sign of said derivative;
  • signal combining means for additively combining the output signals of said first and second signal transforming circuits and providing an output signal whose amplitude is a function of said combined signals
  • a frequency controlled pulse generator receiving the output signal of said signal combining means as a frequency control signal for generating output pulses having a frequency proportional to the amplitude of the output signal of said signal combining means;
  • stimulator means connecting to receive the output pulses of said pulse generator and including at least one electrode means adapted for connection to an afferent nerve from a baroreceptor in the individual.
  • variable signal attenuating means connected between the outputs of said first and second signal transforming circuits and the input of said signal combining means for variation of the relative magnitudes of the signals combined by said signal combining means.
  • pressure responsive transducer means adapted to be connected to the arterial system in the individual for sensing the arterial blood pressure and producing an output signal substantially representing the instantaneous arterial blood pressure in the individual;
  • signal transforming means responsive to the transducer output signal and including (a) a first signal transforming circuit providing an output signal substantially proportional to the mean value of the transducer output signal, and (b) a second signal transforming circuit providing an output signal whose amplitude is substantially proportional to the derivative of the transducer output signal and whose polarity corresponds to the algebraic sign of said derivative;
  • signal combining means for additively combining the output signals of said first and second signal transforming circuits to provide an output signal whose amplitude is a function of said combined signals
  • a frequency controlled pulse generator connected to receive the output signal of said signal combining means as a frequency control signal to generate output pulses having a pulse frequency proportional to the amplitude of the output signal of said signal combining means; said pulse enerator having two out uts for said output pulses; 5. stimu ator means including rig t and left electrode means connected to receive the output pulses from the two outputs respectively of the pulse generator and adapted for connection to the right and left carotid-sinus nerves respectively in the individual; and 6. a pulse delay circuit in the one generator output connection for providing a time delay shorter than the shortest interval between two successive output pulses from the generator to prevent cross-stimulation between the right and left carotid-sinus nerves in the individual.

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US12062A 1969-02-24 1970-02-17 Apparatus for influencing the systemic blood pressure in a patient by carotid sinus nerve stimulation Expired - Lifetime US3650277A (en)

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JP (1) JPS4915438B1 (enrdf_load_stackoverflow)
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GB1297991A (enrdf_load_stackoverflow) 1972-11-29
DE2008316A1 (de) 1971-02-11
FR2032996A5 (enrdf_load_stackoverflow) 1970-11-27
JPS4915438B1 (enrdf_load_stackoverflow) 1974-04-15
SE346468B (enrdf_load_stackoverflow) 1972-07-10

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