System for measurement of impedance cardiography
11666764 · 2023-06-06
Assignee
Inventors
Cpc classification
A61N1/36521
HUMAN NECESSITIES
A61B5/0024
HUMAN NECESSITIES
International classification
A61N1/365
HUMAN NECESSITIES
A61N1/372
HUMAN NECESSITIES
Abstract
The present invention relates to a system of multiple implantable medical devices for an impedance measurement comprising a first implantable medical device, at least a second implantable medical device distinct from the first implantable medical device and; an analysis module comprising at least one amplifier and one envelope detector, one of the first implantable medical device or the second implantable medical device being a subcutaneous implantable cardioverter defibrillator or a subcutaneous loop recorder, and the other of the first implantable medical device or the second implantable medical device being an implantable endocardial device.
Claims
1. A system for measuring impedance, the system comprising: a first implantable medical device comprising at least one dipole emitter formed by two electrodes connected to a generator, the at least one dipole emitter configured to emit an electrical signal; a second implantable medical device distinct from the first implantable medical device and comprising at least one dipole receiver formed by two electrodes, the at least one dipole receiver of the second implantable medical device configured to capture the electrical signal emitted by the at least one dipole emitter of the first implantable medical device; and an analysis module comprising at least one amplifier and at least one envelope detector, the analysis module connected to the at least one dipole receiver, wherein the envelope detector is configured to demodulate the amplitude of the electrical signal captured by the second implantable medical device and the analysis module is configured to treat the demodulated electrical signal to determine a physiological parameter of a patient; wherein: one of the first implantable medical device or the second implantable medical device is a subcutaneous implantable cardioverter defibrillator or a subcutaneous loop recorder; and the other of the first implantable medical device or the second implantable medical device is an implantable endocardial device.
2. The system of claim 1, wherein the analysis module further comprises an analog-digital converter and at least one digital filter configured to treat the electrical signal captured by the second implantable medical device.
3. The system of claim 1, wherein the analysis module comprises a low pass digital filter configured to retrieve physiologic information from the electrical signal captured by the second implantable medical device.
4. The system of claim 3, wherein the low pass digital filter has a cutoff frequency between 0.5 Hz and 5 Hz.
5. The system of claim 1, wherein the analysis module comprises a bandpass digital filter configured to retrieve hemodynamic information of the electrical signal captured by the second implantable medical device.
6. The system of claim 5, wherein the bandpass digital filter has a bandwidth between 0.5 Hz and 30 Hz.
7. The system of claim 1, wherein the analysis module comprises a bandpass low noise amplifier configured to amplify the electrical signal captured by the at least one dipole receiver of the second implantable medical device.
8. The system of claim 1, wherein the analysis module comprises a plurality of low noise amplifiers, and wherein the plurality of low noise amplifiers are selectable based on a position of the at least one dipole emitter of the first implantable medical device with respect to at least one dipole receivers of the second implantable medical device.
9. The system of claim 1, wherein the implantable endocardial device is a leadless cardiac pacemaker.
10. The system of claim 9, further comprising a second leadless cardiac pacemaker, the second leadless cardiac pacemaker comprising at least one of a second dipole receiver or a second dipole emitter.
11. The system of claim 10, wherein an electrical pulse delivered by the at least one dipole emitter of the first implantable medical device or the second dipole emitter of the second leadless cardiac pacemaker is adapted based on a signal captured by the at least one dipole receiver of the second implantable medical device or the second dipole emitter of the second leadless cardiac pacemaker.
12. The system of claim 1, wherein the at least one dipole emitter emits an electrical pulse having a variable amplitude.
13. The system of claim 12, wherein the first implantable medical device further comprises a telemetry module configured to communicate with an external device, and wherein the variable amplitude of the electrical signal emitted by the at least one dipole emitter is adjustable based on a telemetry.
14. The system of claim 1, wherein the electrical signal is modulated via transmission through a propagation medium, and wherein the analysis module is further configured to demodulate the electrical signal to determine the physiological parameter of the patient.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The invention and its advantages will be explained in more detail in the following by means of preferred embodiment and by means of the following accompanying figures, in which:
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DETAILED DESCRIPTION
(11) The invention will now be described in more detail using advantageous embodiments by way of example and with reference to the figures. The embodiments described are simply configurations which are possible and it should be borne in mind that the individual features as described above may be provided independently of each other or may be omitted altogether when carrying out the present invention.
(12)
(13) The implantable subcutaneous device 20 as shown in
(14) Table 1 below lists all configurations of the dipole emitters and dipole receivers which may be used in the implantable subcutaneous device 20.
(15) TABLE-US-00001 TABLE 1 # Emitter or receiver dipole 1 22-26 2 22-28 3 22-30 4 22-32 5 26-28 6 26-30 7 26-32 8 28-30 9 28-32 10 30-32
(16) As indicated in Table 1, one of the electrodes may be constituted by the housing 22 of the implantable subcutaneous device 20. Any of the combinations of electrodes may be used, including the defibrillation electrode 32.
(17) In a variation, an event recorder or an implantable loop recorder comprising at least a pair of electrodes could be used instead of the implantable subcutaneous device 20.
(18) The leadless capsule pacemaker 21 comprises a tip electrode 23 disposed at one distal end 25 of the capsule 21, and a ring electrode 27 disposed towards a proximal end 29 of the capsule. The electrodes 23, 27 may form a dipole receiver or a dipole emitter. It should be noted that the present invention does not limit itself to the use of a tip electrode and a ring electrode but the present invention can be implemented by means of any types of electrodes comprised in a leadless cardiac pacemaker.
In a variation, a cardiac device with an endocardial lead comprising at least one pair of electrodes may be used instead of the leadless cardiac pacemaker 21.
Each of the implantable subcutaneous device 20 and the leadless cardiac pacemaker 21 comprises electrodes 22, 26, 28, 30, 32; 23, 27 which may act as dipole receiver and dipole emitter. Hence, both the implantable subcutaneous device 20 and the leadless cardiac pacemaker 21 may act as emitter or receiver in the implantable system 10 according to the present invention. Moreover, a practitioner may advantageously select the configuration of the dipole emitter and the dipole receiver which is the most suitable for the physiological parameters that are to be captured. The different possible configurations of dipole emitter/dipole receiver with the system 10 are listed in the Table 2 here below.
(19) TABLE-US-00002 TABLE 2 # Emitter dipole Receiver dipole 1 22-26 23-27 2 22-28 23-27 3 22-30 23-27 4 22-32 23-27 5 26-28 23-27 6 26-30 23-27 7 26-32 23-27 8 28-30 23-27 9 28-32 23-27 10 30-32 23-27 11 23-27 22-26 12 23-27 22-28 13 23-27 22-30 14 23-27 22-32 15 23-27 26-28 16 23-27 26-30 17 23-27 26-32 18 23-27 28-30 19 23-27 28-32 20 23-27 30-32
(20) Thus, it is possible to select the configuration of the dipoles which is the most sensitive and/or the most energy-saving, in particular during the lifetime of a patient in whom the devices 20, 21 are implanted. This selection may be carried out in real time using a telemetry module.
(21) The implantation, as shown in
As an example, by using the implantable subcutaneous device 20 as emitter, in particular the pair of electrodes 26, 30, and the leadless cardiac pacemaker 21 implanted in the right ventricle VD as receiver (i.e. the pair of electrodes 23, 27), the information relative to the contraction of the atrium (“atrial kick”) may be recovered by the leadless cardiac pacemaker 21, given that the mechanical activity of the atrium modifies both the quantity of blood present in the right ventricle VD and the orientation of the leadless cardiac pacemaker 21. The information relative to the contraction of the atrium may be used by the leadless cardiac pacemaker 21 in order to adapt the stimulation to the normal activity of the atrium.
(22) In addition, because the system 10 has at least four electrodes such that the dipole emitter is distinct from the dipole receiver, it is possible to obtain a measurement of the impedance which is more global and thus more representative of the surrounding medium than a measurement between only two electrodes of the same lead.
(23)
(24) The elements with the same reference numerals already used for the description of
(25) The system 11 comprises one additional implantable device 31 in comparison to the system 10 shown in
(26) The additional implantable device 31 of system 11 shown in
(27) As for the first the leadless cardiac pacemaker 21, the second leadless cardiac pacemaker 31 comprises a tip electrode 33 disposed at one distal end 35 of the capsule 31, and a ring electrode 37 disposed towards a proximal end 39 of the capsule 31.
(28) The electrodes 23, 27 may form a dipole receiver or a dipole emitter.
(29) It should be noted that the present invention does not limit itself to the use of a tip electrode and a ring electrode but the present invention can be implemented by means of any types of electrodes comprised in a leadless cardiac pacemaker.
(30) The different configurations of dipole emitter/dipole possible by means of the system 11 comprising three devices 20, 21, 31 are listed in the Table 3 here below.
(31) The possible configurations between only two of the three devices 20, 21, 31 are also listed in the Table 3.
(32) TABLE-US-00003 TABLE 3 # Device 20 Capsule 21 Capsule 31 1 Emitter dipole Receiver dipole Receiver dipole 2 Receiver dipole Emitter dipole Receiver dipole 3 Receiver dipole Receiver dipole Emitter dipole 4 Emitter dipole Receiver dipole — 5 Emitter dipole — Receiver dipole 6 — Emitter dipole Receiver dipole 7 Receiver dipole Emitter dipole — 8 Receiver dipole — Emitter dipole 9 — Receiver dipole Emitter dipole
(33) Hence, the system 11 is even more suitable for a trans-thoracic measurement and can be used to detect the changes in volume observed in the right ventricle VD and in the right atrium OD. Indeed, the electrical signal captured by means of the capsule 21 (implanted in the right ventricle VD) and the electrical signal captured by means of the capsule 31 (implanted in the right atrium in the embodiment represented by
(34) As mentioned above, the capsule 21 may, in a variation, be implanted in the left ventricle VG.
(35) In any case, one of the electrical signals may provide more useful information than the other captured electrical signal. The system 11 can thus determine the most suitable propagation channel for the determination of the desired respiratory and hemodynamic parameters.
(36) The system 11 can thus be used to provide a more exhaustive view of the trans-thoracic measurement. Moreover, the system 11 is suitable for stimulating the heart in the right atrium OD.
(37)
(38) The elements with the same reference numerals already used for the description of
(39) The system 12 comprises one additional implantable device 41 in comparison to the system 11 shown in
(40) The additional implantable device of system 12, shown in
(41) As for the first the leadless cardiac pacemaker 21 and the second leadless cardiac pacemaker 31, the third leadless cardiac pacemaker 41 comprises a tip electrode 43 disposed at one distal end 45 of the capsule 41, and a ring electrode 47 disposed towards a proximal end 49 of the capsule 41. The electrodes 43, 47 may form a dipole receiver or a dipole emitter.
(42) It should be noted that the present invention does not limit itself to the use of a tip electrode and a ring electrode but the present invention can be implemented by means of any types of electrodes comprised in a leadless cardiac pacemaker.
(43) The first leadless cardiac pacemaker 21 implanted in the right ventricle VD, the second leadless cardiac pacemaker 31 implanted in the right atrium OD, and the third leadless cardiac pacemaker 41 implanted in the left ventricle VG form constitute a leadless implantable cardiac resynchronization system 50, i.e. without lead.
(44) The implantable cardiac resynchronization system 50 known as a “triple chamber” system (right ventricle VD, right atrium OD and left ventricle VG) is suitable for the treatment of cardiac insufficiency (also known as heart failure), in addition of being configured for the diagnosis and the monitoring of cardiac insufficiency. In fact, in the implantable cardiac resynchronization system 50, the therapy can be optimized by taking into account physiological parameters recovered from the electrical signals. The implantable cardiac resynchronization system 50 is particularly suitable for synchronizing the intraventricular contraction and the interventricular contraction by means of the third leadless pacemaker pacemaker 41 implanted in the left ventricle VG.
(45) Both the implantable subcutaneous device 20 and the leadless cardiac pacemakers 21, 31, 41 may act as emitter or receiver in the implantable system 12 according to the present invention. Moreover, a practitioner may advantageously select the configuration of the dipole emitter and the dipole receiver which is the most suitable for the physiological parameters that are to be captured.
(46)
(47) The
(48) By applying an electrical signal, the dipole emitter D.sub.e is used to generate an electric field E which propagates through the tissues of a human body to a dipole receiver D.sub.r. The dipole receiver D.sub.r is formed by an E3 electrode and an E4 electrode. The dipole receiver D.sub.r detects a potential difference of the electric field E by means of the detected electric signal.
(49) The detected electrical signal principally depends on four factors, which are: the length “d” of the propagation channel, i.e. the distance between the dipole emitter D.sub.e and the dipole receiver D.sub.r; the orientation “α” of the dipoles D.sub.e, D.sub.r with respect to each other; the inter-electrode distances “d.sub.e1” and “d.sub.e2” for the dipoles D.sub.e, D.sub.r, i.e. the distance between the electrodes E1, E2 and the distance between the electrodes E3, E4; and the electrical properties of the propagation medium.
(50) As can be seen in
(51) When the implantable medical system according to the present invention is implanted in a human body, in particular in or in the vicinity of the heart, as shown by the system 10 in
(52) In the following, the analysis module of the system of the present invention will be further described according to several embodiments.
(53)
(54) The system 100 in accordance with the first embodiment of the invention comprises a first device 102 comprising a dipole emitter D.sub.e and a second device 104 comprising a dipole receiver D.sub.r. The dipole emitter D.sub.e is formed by the pair of electrodes E1, E2 and the dipole receiver D.sub.r is formed by the pair of electrodes E3, E4. The dipole emitter D.sub.e is comprised in the implantable device 102 which is distinct from the device 104 comprising the dipole receiver D.sub.r. Moreover, a pair of electrodes is arranged in a subcutaneous manner while the other pair of electrodes is formed by means of endocardial electrodes.
(55) The dipole emitter D.sub.e is connected to a generator 106 at a defined frequency f.sub.0, while the dipole receiver D.sub.r is connected to an analysis module 108. The generator 106 may be a voltage or current generator.
(56) It should be noted that the frequency f.sub.0 must be sufficiently high not to stimulate the heart of a patient by interfering with the normal cardiac activity of the patient.
(57) Accordingly, the defined frequency f.sub.0 is preferentially more than 1 kHz, in particular more than 10 kHz, so as not interfering with the physiological signals of the patient.
(58) Advantageously, using a lower frequency, in particular below 10 kHz, allows saving energy.
(59) The analysis module 108 comprises a front-end low noise amplifier 110 for amplifying the signal captured by the dipole receiver D.sub.r followed by an envelope detector 112. The amplifier 110 may comprise an analogue filter.
(60) The envelope detector 112 performs an amplitude demodulation of the electrical signal by retrieving the information of the dipoles which may be correlated with hemodynamic parameters and respiratory frequency.
(61) The envelope detector 112 is followed by an analogue-to-digital converter 114 configured to sample the captured electrical signal.
(62)
(63) The system 200 in accordance with the second embodiment of the invention comprises a first device 202 comprising a dipole emitter D.sub.e and a second device 204 comprising a dipole receiver D.sub.r.
(64) As in the first embodiment, the dipole emitter D.sub.e is formed by the pair of electrodes E1, E2 and the dipole receiver D.sub.r is formed by the pair of electrodes E3, E4. The dipole emitter D.sub.e is comprised in the implantable device 202 which is distinct from the device 204 comprising the dipole receiver D.sub.r. Hence, the electrodes E1, E2 are distinct from the electrodes E3, E4. Moreover, a pair of electrodes is arranged in a subcutaneous manner while the other pair of electrodes is formed by means of endocardial electrodes.
(65) The dipole emitter D.sub.e is connected to a generator 206 at a defined frequency f.sub.0, while the dipole receiver D.sub.r is connected to an analysis module 108.
(66) The dipole emitter D.sub.e of the system 200 may emit an electrical signal with variable amplitude. Thus, the amplitude of the electrical signal emitted by the dipole emitter D.sub.e can be adjusted once the implantable devices 202, 204, and thus the dipoles emitter/receiver, are implanted in a patient's body in order to obtain a suitable signal-to-noise ratio for detection at the dipole receiver D.sub.r.
(67) The implantable 204 may further comprise a telemetry module (not represented in
(68) According to the second embodiment of the invention, the analysis module 208 comprises a plurality of n low noise amplifiers 210n selectable according to the position of the dipole emitter D.sub.e with respect to the dipole receiver D.sub.r. In fact, the relative positioning of the dipole emitter D.sub.e in relation to each dipole receiver D.sub.r has an influence on the properties of the propagation channel of the electrical signal. Therefore, according to the channel attenuation caused by the mutual position of the implantable devices 202, 204, the implantable device 204 comprising the dipole receiver D.sub.r may select the low noise amplifier which gain is best adapted to the captured signal. In this manner, the energy consumption of the system 200 may be optimized by activating only the low noise amplifier necessary for providing sufficient detection of the electrical signal for the measurement, i.e. which satisfies a certain predefined signal-to-noise ratio.
(69) In the analysis module 208 of the implantable device 204, the plurality of low noise selectable amplifier 210.sub.n is followed by a multiplexer 212 itself followed by an envelope detector 214.
(70) The analysis module 208 further comprises an analogue-to-digital converter 216 and digital filters 218 configured for processing the electrical signal captured by means of the dipole receiver D.sub.r. Hence, after the envelope detector 214, the captured and detected signal may be sampled by the analogue-to-digital converter 216 of the analysis module 208 and digitally filtered for discriminating respiration information from hemodynamic information, as explained in the following.
(71) The analysis module 208 comprises a digital filtering means. In particular, the analysis module 208 comprises a low pass digital filter configured to extract respiratory information from the captured electrical signal, more in particular a low pass digital filter with a cutoff frequency f.sub.c comprised between 0.5 Hz and 5 Hz, even more in particular with a cutoff frequency f.sub.c=1 Hz.
(72) The analysis module 208 further comprises a bandpass digital filter configured to retrieve hemodynamic information of the captured electrical signal, in particular a bandpass digital filter with a bandwidth comprised between 0.5 Hz and 30 Hz, more in particular between 1 Hz and 10 Hz.
(73) The frequency range of 0.5 Hz to 30 Hz allows both filtering of the respiratory artifact by cutting frequencies below 0.5 Hz and filtering of high-frequency noises, i.e. noises with a frequency above 30 Hz, in particular the high-frequency noises with a frequency of the order of 50 to 60 Hz.
(74) It should be noted that the frequency range selection for the bandpass digital filter may allow savings in terms of digital processing.
(75) Hence, the system 200 may be used for retrieving hemodynamic information and respiration information from the same signal acquisition using digital filters 218 suitable to discriminate the different information.
(76)
(77) The system 300 in accordance with the third embodiment of the invention comprises a first implantable device 302 comprising a dipole emitter D.sub.e and a second implantable device 304 comprising a dipole receiver D.sub.r.
(78) As in the first and the second embodiments, the dipole emitter D.sub.e is formed by the pair of electrodes E1, E2 and the dipole receiver D.sub.r is formed by the pair of electrodes E3, E4. The dipole emitter D.sub.e is comprised in the first implantable device 302 which is distinct from the device 304 comprising the dipole receiver D.sub.r. Hence, the electrodes E1, E2 are distinct from the electrodes E3, E4. Moreover, a pair of electrodes is arranged in a subcutaneous manner while the other pair of electrodes is formed by means of endocardial electrodes.
(79) The dipole emitter D.sub.e is connected to a generator 306 at a defined frequency f.sub.0, while the dipole receiver D.sub.r is connected to an analysis module 308.
(80) The analysis module 308 comprises variable gain amplifier 310 followed by an envelope detector 312. The variable gain amplifier 310 is controlled by adjusting a control voltage Vc.
(81) In the same manner as the analysis module 208 described in reference of
(82)
(83) The system 400 in accordance with the fourth embodiment of the invention comprises a first implantable device 402 comprising a dipole emitter D.sub.e and a second implantable device 404 comprising a dipole receiver D.sub.r.
(84) As in the preceding embodiments, the dipole emitter D.sub.e is formed by the pair of electrodes E1, E2 and the dipole receiver D.sub.r is formed by the pair of electrodes E3, E4. The dipole emitter D.sub.e is comprised in the first implantable device 402 which is distinct from the second implantable device 404 comprising the dipole receiver D.sub.r. Hence, the electrodes E1, E2 are distinct from the electrodes E3, E4. Moreover, a pair of electrodes is arranged in a subcutaneous manner while the other pair of electrodes is formed by endocardial or epicardial electrodes.
(85) The dipole emitter D.sub.e is connected to a generator 406 at a defined frequency f.sub.0, while the dipole receiver D.sub.r is connected to an analysis module 408.
(86) The analysis module 408 is comprised in the implantable second device 404 comprising the dipole receiver D.sub.r.
(87) The analysis module 408 comprises a programmable gain amplifier 410 followed by an envelope detector 412, an analogue-to-digital converter 414 and digital filters 416.
(88) The analogue-to-digital converter 414 and the digital filters 416 are identical to those of the analysis module 308 in
(89) The programmable gain amplifier 410 is digitally controlled by means of an internal microcontroller 418.
(90)
(91) The implantable device 502 is a subcutaneous implantable cardioverter defibrillator.
(92) In a variation, the implantable device 502 is a subcutaneous loop recorder.
(93) In a further variation, the implantable device 502 is an implantable endocardial device.
(94) The implantable device 502 comprised two electrodes E1, E2 which may form a dipole receiver as well as a dipole emitter.
(95) The implantable device 502 comprises a generator 504 which can be used as a generator for the dipole emitter E1, E2—in the case wherein the pair of electrodes E1, E2 forms a dipole emitter.
(96) The implantable device 502 comprises an analysis and control module 506.
(97) In the analysis and control module 506, after a multiplexer 507, the implantable device 502 comprises a low noise amplifier 508, an envelope detector 510, an analogue-to-digital converter 512 and digital filters 514.
(98) As shown in
(99) The system according to the present invention is thus configured for retrieving hemodynamic and respiration information from the same signal acquisition, in particular by means of digital filters 218 suitable to discriminate the different information.
(100) It should be noted that in each of the electrodes dipole may act as the dipole emitter and also as the dipole receiver. The system according to the invention makes it possible to select the configuration of the dipoles which is the most sensitive and/or the most energy-saving.
(101) The described embodiments are simply possible configurations and it should be borne in mind that the individual characteristics of the different embodiments can be combined with each other or provided independently of each other. Reference to the singular should also be interpreted as referring to the plural.