WikiPatents - Community Patent Review
Create Free Account  |  License or Sell Your Patent  |  WikiPatents Marketplace  |  WikiPatents Blog
Username:  Password:  
    
Advanced Search
System for detecting heart pacemaker pulses    
United States Patent4226245   
Link to this pagehttp://www.wikipatents.com/4226245.html
Inventor(s)Bennett, Jr.; Robert M. (Ham Lake, MN)
AbstractA system is disclosed for accurately providing a signal or signals indicative of the relatively sharp leading edge and the relatively attenuated trailing edge of a pulse and in particular of a pulse applied by a heart pacemaker to a patient's heart. The system of this invention functions to distinctly detect each of the relatively fast rising leading edge and the relatively slow rising trailing edge, while preventing a premature detection of the trailing upon the attenuated or drooping portion of the pacing pulse therebetween.
   














 Title Information Submit all comments and votes
 
Patent Text Patent PDF Print Page Summary File History
Plain text PDF images Print Summary File History
Drawing from US Patent 4226245
System for detecting heart pacemaker pulses - US Patent 4226245 Drawing
System for detecting heart pacemaker pulses
Inventor     Bennett, Jr.; Robert M. (Ham Lake, MN)
Owner/Assignee     Medtronic, Inc. (Minneapolis, MN)
Patent assignment
All assignments
Publication Date     October 7, 1980
Application Number     05/957,815
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     November 6, 1978
US Classification     607/27
Int'l Classification     A61N 001/36
Examiner     Kamm; William E.
Assistant Examiner    
Attorney/Law Firm     Lewis, Breimayer; Joseph F. Gable; R .
Address
Parent Case    
Priority Data    
USPTO Field of Search     128/419 PT 128/697 128/696
Patent Tags     detecting heart pacemaker pulses
   
Enter a comma (,) or semicolon (;) between multiple tag words/phrases.
Describe this patent:
 Amusing   
 Clever   
 Complex   
 Efficient   
 Historic   
 Important   
 Innovative   
 Interesting   
 Practical   
 Simple   
[no votes]
Patent WIKI

Share information and news about this patent, including information and news about the technology, inventors, company, ligation and licensing.

 References Submit all comments and votes
 
*references marked with an asterisk below are user-added references
 U.S. References
 
Add a new US reference:  
ReferenceRelevancyCommentsReferenceRelevancyComments
3498288



[0 after 0 votes]
4087637
DeKont
379/106.02
May,1978

[0 after 0 votes]
3986496
Brastad
600/510
Oct,1976

[0 after 0 votes]
3923041
Stasz
600/510
Dec,1975

[0 after 0 votes]
 Foreign References
 Other References
 Market Review Submit all comments and votes
   
Market Size
Estimate the gross annual revenues of the relevant market sector:
> $10B
$5B - $10B
$2B - $5B
$500M - $2B
$100M - $500M
$10M - $100M
$1M - $10M
$500K - $1M
$100K - $500K
< $100K
[No votes]
$0
 
$0   $2.5B   $5B   $7.5B   $10B
Market Share
Estimate the percentage of the relevant market sector this invention will capture:
75% - 100%
50% - 74.99%
25% - 49.99%
10 - 24.99%
5 - 9.99%
2 - 4.99%
1 - 1.99%
< 1%
[No votes]
0.0%
 
0%   25%   50%   75%   100%
Reasonable Royalty
What percentage of gross sales should the inventor or assignee be paid?
75% - 100%
50% - 74.99%
25% - 49.99%
10 - 24.99%
5 - 9.99%
2 - 4.99%
1 - 1.99%
< 1%
[No votes]
0.0%
 
0%   25%   50%   75%   100%
Public's "Guesstimation" of Royalty Value
Market SizeN/A[No votes]
xMarket ShareN/A[No votes]
xReasonable RoyaltyN/A[No votes]

N/A

License Availablity
If you are NOT the owner or assignee, answer here:
Yes, license is available for purchase

No, license is not currently available



[No votes]
License Availablity
If you ARE the owner or assignee, answer here:
Yes, license is available for purchase

No, license is not currently available



[No votes]
Competitive Advantage
Does this invention have a significant competitive advantage over similar technologies?
Yes

No



[No votes]
Most helpful competitive advantage comment
[No comments]

Commercial Alternatives
Are there viable commercial alternatives for this invention?
Yes

No



[No votes]
Most helpful commercial alternative comment
[No comments]

 Technical Review Submit all comments and votes
 Claims Submit all comments and votes
 


I claim:

1. Apparatus for accurately detecting the pulse width of simulating pulses applied by an artificial pacemaker to a patient's heart, each of the stimulating pulses comprising a relatively fast rising leading edge followed by an attenuated wave form portion and terminating in a relatively slow falling trailing edge, said apparatus comprising:

wave shaping amplifier means for receiving and amplifying the stimulating pulses along with low frequency noise signals in accordance with a transfer function such that low frequency component signals are amplified with a relatively low gain and higher frequency component signals are amplified with a relatively high gain whereby said noise signals are substantially discriminated against;

first normally deactuated threshold means responsive to the output of said amplifier means of an amplitude greater than a first predetermined level for providing a first output signal indicative of the occurrence of the trailing edge;

differential amplifier means responsive to the output of said amplifier means and to the stimulating pulses and noise signals, for providing a difference output signal corresponding to the difference between the input signals;

second normally actuated threshold means responsive to the difference output of an amplitude greater than a second predetermined level for providing a second output signal indicative of the occurrence of the leading edge;

said transfer function of said amplifier means and said first predetermined level being selected to provide an accurate indication of the occurrence of the trailing edge without prematurely responding to the attenuated wave form portion of the stimulating pulse; and

means responsive to the second output signal for disabling said second threshold means and for enabling said first threshold means to initiate detection of the trailing edge of the stimulating pulse.

2. Apparatus as claimed in claim 1, wherein said first threshold means is responsive to a wave shaping amplifier output of an amplitude greater than the first predetermined level and of a first polarity to provide the first output signal and to a wave shaping amplifier output of an amplitude greater than the first predetermined level and of a second polarity opposite to the first polarity for providing a third output signal, said second threshold means responsive to a differential amplifier output of an amplitude greater than the second predetermined level and of the first polarity for providing the second output signal and to a differential amplifier output of an amplitude greater than the second predetermined level and of the second polarity for providing a fourth output signal.

3. Apparatus as claimed in claim 2, wherein there is further included logic means responsive to the second output signal and the subsequent first output signal to provide a pulse-like signal having a leading and trailing edge accurately corresponding to the leading and trailing edges of the stimulating pulse.

4. Apparatus as claimed in claim 3, wherein said logic means comprises a first flip-flop coupled to said second threshold means and set in response to the second output signal to provide a first high going logic signal and reset in response to said fourth output signal to provide a first low going output logic signal, and a second flip-flop coupled to said first threshold means and reset in response to said first output signal to provide a second low going output logic signal and set in response to the third output signal to provide a second high going output logic signal.

5. Apparatus as claimed in claim 4, wherein said logic means comprises an exlcusive NOR gate responsive to the first and second logic output signals to provide a pulse like output signal whose leading and trailing edges correspond respectively to the leading and trailing edges of the stimulating pulse.

6. Apparatus as claimed in claim 2, wherein there is further included logic means responsive to the fourth output signal and the subsequent third output signal to provide a pulse-like signal having a leading and trailing edge accurately corresponding to the leading and trailing edges of the stimulating pulse.

7. Apparatus as claimed in claim 1, wherein said wave shaping amplifier means has a time constant set sufficiently high to provide the first output signal with an amplitude greater than the second predetermined level and sufficiently low to reject undesired low frequency noise.

8. Apparatus as claimed in claim 7, wherein there is further included amplifier means for amplifying and applying the shaping amplifier output to said first threshold means.

9. Apparatus as claimed in claim 8, wherein said amplifier means has a selected gain, said gain of said amplifier means, said first predetermined level and said time constant of said wave shaping amplifier means selected so that said first threshold means provides an output indicating the occurrence of the attenuated trailing edge of a stimulating pulse.

10. Apparatus for accurately detecting the relatively sharp leading edge and attenuated trailing edge of stimulating pulses applied by an artifical pacemaker to a patient's heart and for transmitting the detected stimulating pulses, combined with cardiac signals of a patient's heart, over a limited bandwidth medium to a remote station, said apparatus comprising:

(a) selectively actuatable modulation means for generating a carrier signal of a frequency suitable to be transmitted over the limited bandwith medium;

(b) detection means for accurately detecting the pulse width of stimulating pulses applied by an artificial pacemaker to a patient's heart, each of the stimulating pulses comprising a relatively the fast rising leading edge followed by an attenuated wave form portion and terminating in the relatively slow falling trailing edge, said detector means comprising:

(1) wave shaping amplifier means for receiving and amplifying the stimulating pulses along with low frequency noise signals in accordance with a transfer function such that low frequency component signals are amplified with a relatively low gain and higher frequency component signals are amplified with a relatively high gain such that said noise signals are substantially discriminated against;

(2) first normally deactuated threshold means responsive to the output of said amplifier means of an amplitude greater than a first predetermined level for providing a first output signal indicative of the occurrence of the trailing edge;

(3) differential amplifier means responsive to the output of said amplifier means and to the stimulating pulses and noise signals, for providing a difference output signal corresponding to the difference between the input signals;

(4) second normally actuated threshold means responsive to the difference output of an amplitude greater than a second predetermined level for providing a second output signal indicative of the occurrence of the leading edge;

(5) said transfer function of said amplifier means and said first predetermined level being selected to provide an accurate indication of the occurrence of the trailing edge without prematurely responding to the attenuated wave form portion of the stimulating pulse; and

(6) means responsive to the second output signal for disabling said second threshold means and for enabling said first threshold means to initiate detection of the trailing edge of the stimulating pulse; and

(c) means responsive to the first and second output signals for providing a pulse like signal having a pulse width expanded with respect to the period between the first and second output signals and applying the pulse like signal to actuate said modulation means to transmit the carrier signal over the limited bandwidth medium for the expanded pulse width.

11. Apparatus for accurately detecting the pulse width of stimulating pulses applied by an artificial pacemaker to a patient's heart, each of the stimulating pulses including a relatively fast rising leading edge, a relatively slow falling trailing edge and an attentuated, sloping portion therebetween, said apparatus comprising:

(a) first detection means coupled to receive the stimulating pulses along with noise signals for detecting the leading edge of each of the stimulating pulses and for providing a first output indicative of the occurrence thereof; and

(b) second detector means actuatable after the detection of the leading edge for detecting the trailing edge of each stimulating pulse and coupled to receive and variably amplify each of the stimulating pulses in accordance with a transfer function such that said second detector means provides a second output signal indicative the occurrence of the trailing edge without prematurely responding to the attenuated, sloping portion to provide a false indication of the occurrence of the trailing edge.
 Description Submit all comments and votes
 


CROSS REFERENCE TO COPENDING APPLICATIONS

Attention is drawn to the following copending, commonly assigned applications, all filed on the same date and further describing the overall system in which the subject invention is incorporated:

"CARDIAC PACEMAKER HAVING A RATE LIMIT", by David L. Thompson, Ray S. McDonald, and Yan Sang Lee, Ser. No. 957,828, filed Nov. 6, 1978;

"DEMAND CARDIAC PACEMAKER HAVING REDUCED POLARITY DISPARITY" by Gerome P. Hartlaub and Ray S. McDonald, Ser. No. 957,812; filed Nov. 6, 1978;

"DIGITAL CARDIAC PACEMAKER" by David L. Thompson, Gerome P. Hartlaub, Ray S. McDonald, and Martin A. Rossing, Ser. No. 957,960, filed Nov. 6, 1978;

"FREQUENCY TO VOLTAGE CONVERTER FOR CARDIAC TELEMETRY SYSTEM" by Stanley L. Gruenenwald, Ser. No. 958,202, filed Nov. 6, 1978;

"PROGRAMMING AND MONITORING APPARATUS FOR A PROGRAMMABLE PACING GENERATOR" by Robert Smith, Ser. No. 958,063 (now indicated to be allowed), filed Nov. 6, 1978.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to systems for detecting the occurrence of the leading and trailing edges of pulses and in particular of those pulse-like signals applied by a pacemaker to a patient's heart.

2. Description of the Prior Art

Heart pacemakers such as that described in U.S. Pat. No. 3,057,356, issued in the name of Wilson Greatbatch and assigned to the assignee of this invention, are known for providing electrical stimulating pulses to a patient's heart whereby it is contracted at a desired rate in the order of 72 beats per minute. A heart pacemaker is capable of being implanted in the human body and operative in such an environment for relatively long periods of time, to provide cardiac stimulation at relatively low power levels by utilizing a small, completely implanted, transistorized, battery-operated pacemaker connected via flexible electrode wires directly to the myocardium or heart muscle. The electrical stimulating pulses by this pacemaker are provided at a relatively fixed rate.

Typically, such heart pacemakers are encapsulated in a substance substantially inert to body fluids, and are implanted within the patient's body by a surgical procedure wherein an incision is made in the chest beneath the patient's skin and above the pectoral muscles or in the abdominal region, and a pacemaker is implanted therein. Due to the inconvenience, expense and relative risk to the patient's health, it is highly desired to extend the life of the power source or battery, whereby the number of such surgical procedures is limited. The resultant problem for the attendant doctor is to determine when the batteries should be replaced, keeping in mind the relative risk or probability of premature pacer failure due to battery depletion.

After surgical implantation of an artificial heart pacemaker by known surgical techniques, the patient is required to have periodic checkups so that the heart pacemaker function may be monitored for possible battery or other failure.

A major problem with these devices is that battery failure is not precisely predictable statistically and while statistics do exist they are unfortunately gathered after pacemaker failure has occurred. Further, present heart pacemakers available have a functional life expectancy of about two to five years, but individual ones may not exceed this, and in fact may rather unpredictably fail before this statistical determined period. Usually approximately 90 percent of heart pacemaker failures are battery failures, and the remaining 10 percent are a result of other types of failures, the next most common failure being in the leads themselves. Electronic component failure in artificial cardiac pacers is generally a very small factor. However, all of these factors must be considered when diagnosing a possible malfunction.

The number and kinds of variables that exist make an accurate a priori prediction of the lifetime of a given heart pacemaker difficult. The problem therefore is that of measuring the heart pacemaker pulse, the interval between impulses and some characteristics or set of characteristics which will allow determination in advance of a critical situation, i.e., when the heart pacemaker is about to fail.

One such characteristic is that as the battery starts to fail, the voltage output of the pulses starts to drop and generally as the voltage drops the width of the pacemaker pulse changes. Further, in most heart pacemakers the rate of firing changes.

Most pacemakers generally are powered by 4 or 5 miniature batteries. Present monitoring techniques are geared to detect when the first of those 5 batteries has failed, which means that the safety factor is decreased. In any event, a failure of not only one cell but generally two can be tolerated before the patient is in any danger. It should be cautioned however that when a battery does fail, it fails very rapidly. The battery voltage remains almost constant throughout the lifetime of the battery. Therefore, changes may be detected in the pacemaker output pulses by comparing measurements from one checkup to another.

In one approach to the problem of accurately determining battery depletion, pacemakers such as described in U.S Pat. No. 3,842,844 are provided with a battery or cell depletion indicator that increases the pulse width of the output signal as their batteries deplete, i.e., their voltage amplitude decreases. Further, as the power source or battery depletes, the pulse repetition rate of such artificial cardiac pacemakers also decreases. For example, at the time of implantation, a heart pacemaker may produce stimulating pulses at 70 beats per minute (BPM), plus or minus two beats, with a pulse width in the order of 0.5 msec. After a period of service illustratively in the order of 2-4 years, the BPM changes in the order of 5-10%, i.e., a decrease of 5-7 beats from the original BPM, and the pulse width may increase to a value in the order of 1 msec. Dependent upon the known histories of such batteries, such a change in the BPM as well as a change in pulse width indicates that one of a plurality (e.g. 4 or 5) cells has failed, and that it is time to replace the batteries within the implanted pacemaker to assure continued heart stimulation of a sufficient level.

Pulse width increase is desired to order that as the amplitude of the voltage provided from the pacemaker battery decreases, the total energy in the stimulating pulse remains substantially constant. It is understood that the voltage level of the pacemaker battery may decrease below a level at which the heart may not respond regardless of the pulse width. Further, as the pulse width increases to compensate for decreases in the voltage level, the current drain upon the battery increases, thereby increasing the rate of battery depletion.

In order to detect the patient's electrical heart activity, electrodes are attached for example to the patient's body including his right arm, left arm, left leg, chest and right leg. The electrical activity, as shown in FIG. 2, includes the patient's ECG signal upon which is impressed the pacer pulse appearing before the QRS wave form, which is generated naturally by the heart's activity. The pacer pulse is usually of large amplitude and very small width. Though noting that it is desired to measure the width of the pacer pulse, it is very difficult to determine the width with accuracy. Conventional monitors, for example, do not have a sufficient band width to pass the pacer pulse with any reasonable degree of fidelity. Further, it is necessary to distinguish the pacer pulse from the patient's QRS wave, as well as 60 cycle noise and muscle artifacts. One of the distinguishing characteristics of the pacer pulse is that it has a very fast rise time, being typically in the microsecond range. By contrast, the electrical impulses normally originated in the heart or other noise sources such as 60 Hz line noise, have rise times in the order of 10-20 milliseconds. Other common noise sources may be generated by electrical appliances being operated from the same power line. These generally have fast rise times but very short duration. Since these individual pulses generally are only of fractions of microseconds long, they are distinguished from heart pacemaker pulses principally by the pulse widths since heart pacemaker pulses are commonly in the 1 millisecond range. Thus, the heart pacemaker pulses may be identified by their relatively fast time and their relatively long pulse width in the order of 0.5-4 milliseconds.

In U.S. Pat. No. 3,885,552 of Kennedy, there is disclosed a cardiac monitoring system for monitoring the heart activity and in particular for measuring among other parameters the width of the heart pacemaker pulses. In particular, there is disclosed a pacer pulse selection logic circuit including a differentiator having a time constant of approximately 100 microseconds for providing an output if the applied input has a rise time shorter than 100 microseconds. Further, the noted logic circuit also includes an integrator circuit providing a signal going low indicating that the pulse width of the applied signal is greater than a selected minimum pulse width of 250 microseconds. The Kennedy circuit functions to provide an output identifying the presence of a pacer pulse upon the occurrence of both a signal from the aforementioned differentiator and integrating circuits. For a similar disclosure of a system for detecting the presence of a pacer pulse, attention is also drawn to U.S. Pat. No. 3,871,363 of Day which similarly discloses the use of a differentiator circuit and an integrator circuit for respectively measuring rise times smaller than a selected minimum and pulse widths in excess of a predetermined width to identify thereby heart pacemaker pulses.

Reference is made to FIG. 5, which generally shows an implanted pacemaker of the type generally described above having an output capacitor C3 that is coupled by suitable electrodes to the patient's heart, which for the sake of simplicity may be considered as presenting an essentially resistive impedance to the output of the heart pacemaker. In typical operation, the pacemaker generates a series of timing pulses applied to the base of transistor Q thereby rendering this transistor Q conductive and "dumping" the charge established upon capacitor C3 across the heart's resistance R2. It is recognized, that such a circuit is essentially a differentiation circuit, whereby the electrical signal discharged across the resistor R2 has an essentially sloping or curved wave-form as indicated in FIG. 4A. As shown in FIG. 4A, the pulse appearing between times t1 and t2 has a very fast rise time beginning at time t1, generally sloping down to time t2 with the fast fall time at that instant; this pulse has relatively sharp, well defined leading and trailing edges making its detection relatively easy. However, in practice, the detected wave shape of a pacemaker pulse is more as shown in the time interval between t3 and t5, of FIG. 4A. Generally, the differentiation process effected by the output capacitor C3 and the heart's resistance R3 accounts for the relatively poor wave shape quality, i.e., attenuated quality of this pulse. Thus, it may be observed that the leading edge is relatively well defined and thus may be accurately detected. On the other hand, the trailing edge is of a degraded wave form making its detection more difficult. Thus, it is difficult to accurately detect and measure the pulse width of such a heart pacemaker pulse.

In the above-noted prior circuits for detecting pulse widths, a differentiator circuit is used to detect the leading and trailing edges. Typically, there is no problem in detecting the occurrence of the leading edge of a pacer pulse, which under normal circumstances has a sufficiently fast rise time to actuate normal differentiator circuits to provide a defined output pulse. Similarly, prior art differentiator circuits are capable of providing an output corresponding to the trailing edge, even of a degraded pulse as shown in FIG. 4A. The problem then arises when the attenuated or degraded slope of the pulse occurring between the leading and trailing edges may have a sufficiently fast fall time such that the output of the differentiator circuit may have a sufficient amplitude so as to cause the associated threshold circuit to provide a premature output indicative of the trailing edge. As shown in FIG. 4A, the drooping waveform portion of the pacemaker pulse is essentially capacitive in nature being attenuated by the indicated expression. Therefore, the droop or attenuation associated with the detected artifact pulse is predictable, assuming that a reasonable range of capacitive coupling is made to the patient's heart. The worst contemplated case of attenuation is considered to be a decrease in impulse amplitude of 50% within a time period of 200 microseconds or 80% in 1 millisecond. In other words, the leading edge of a degraded pulse may have a time constant in the order of 3 or 4 microseconds, the trailing edge a time constant in the order of 70 microseconds, and the attenuated or drooping intermediate waveform portion may have a time constant in the order 620 microseconds. Though many multiples of either the leading or trailing edge, the time constant of the drooping portion may be sufficient to provide a premature indication of the trailing edge and therefore an incorrect indication of the pulse width.

SUMMARY OF THE INVENTION

The system of this invention functions to detect the leading and trailing edges of an electrical pulse and in particular of a pulse applied by a heart pacemaker to a patient's heart. The system of this invention functions to distinctly detect each of the relatively fast rising leading edge and the relatively slow rising trailing edge, while preventing a premature detection of the trailing upon the attenuated or drooping portion of the pacing pulse therebetween. The patient's heart activity signals comprising the pacing pulse is applied along with extraneous noise including the patient's QRS wave, 60 Hz noise, muscle artifacts, etc., are applied to a differentiator or wave shaping amplifier whose gain or transfer function is configured to reject signals having low frequency components, i.e., the noise signals mentioned above. The output of the differentiator is applied to a first input of a differential amplifier, while the aforementioned heart activity signals are applied to a second input; the differential amplifier circuit essentially subtracts the amplifier output from the heart activity signals to remove the DC component from the output of the amplifier circuit. If the amplifier output is above a predetermined amplitude, the differential amplifier output is applied to a first threshold circuit or leading edge detector to provide an output signal indicative of the occurrence of the leading edge, and to set a one shot circuit, which in turn provides a signal initiating the detection of the trailing edge. The output of the wave shaping amplifier is also applied via a limiter or amplifier to a second threshold circuit, which responds to signals above a predetermined threshold to provide a signal indicative of the occurrence of the trailing edge. Noting that the output of the waveshaping amplifier is less to the trailing edge than the leading edge, the gain of the amplifier, as well as the time constant of the waveshaping amplifier and the threshold level of the second threshold detector is set to detect the trailing edge of the pacemaker pulse. The output of the first threshold circuit corresponding to the leading edge and the output of the second threshold circuit corresponding to the trailing edge are applied to a logical circuit to provide a defined output pulse whose leading and trailing edges sharply define the leading and trailing edges of the pacer pulse and therefore the pulse width therebetween.

In an illustrative embodiment of this invention, the pulse width detection circuit is incorporated into a low bandwidth transmission system, wherein the heart activity of the patient is transmitted over a low band width transmission medium, e.g., a telephone line, to a remote station as in a physician's office whereat the physician may observe not only the pulse width of the cardiac pulse but also the heart's ECG signal. At the transmitter of such a system, the ECG signals are amplified and applied to a voltage controlled oscillator (VCO) to provide an audio output signal of a frequency dependent upon the amplitude of the input voltage. The heart activity signal is also applied to the aforementioned pulse width detection circuit whereby the pulse width of the pacemaker pulse is accurately detected and subsequently stretched by a given factor to cause the aforementioned VCO to oscillate at a predetermined frequency. Thus, a signal corresponding to the ECG of the patient's heart and a signal indicative of the pulse width of the pacer pulse, i.e., the signal of predetermined frequency, are transmitted via a transducer and the low bandwidth transmission medium to the remote station, where they are detected and appropriately displayed.

BRIEF DESCRIPTION OF THE DRAWINGS

The advantages of the present invention will become more apparent by referring to the following detailed description and accompanying drawings, in which:

FIG. 1A is a functional block diagram showing a transmitter for detecting and transmitting heart activity signals via a low bandwidth transmission medium to a receiver, as shown in FIG. 1B;

FIG. 2 is a graph showing a patient's ECG signal upon which there has been imposed pacer pulse signals;

FIG. 3 is a functional block diagram of the transmitter particularly illustrating the pulse width detector in accordance with the teachings of this invention;

FIGS. 4A-4H show the wave forms of various signals as imposed upon the pulse width detector of FIG. 3;

FIG. 5 is a functional block diagram of the circuit formed by the output of a heart pacemaker and the patient's heart;

FIGS. 6A, B and C are detailed circuit diagrams of the transmitter and pulse width detector as more generally shown in FIG. 3;

FIG. 7 is a graph showing the transfer function or graph of the wave shaping amplifier or differentiator of FIGS. 3 and 6C; and

FIGS. 8A and 8B show respectively a theoretical model of electrical operation of the wave shaping amplifier, and the desired and undesired responses of such an amplifier.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings and in particular to FIG. 1B, there is shown a simplified diagram illustrating the relationship of a transmitter 10 for detecting and transmitting the electrical activity of the patient's heart, e.g., the patient's electrocardiogram (ECG) upon which has been superimposed the detected stimulating pulse in accordance with the teachings of this invention, across a relatively low bandwidth transmission medium 50 to be received by a receiver 60, which operates to separate the multipled or stretched stimulating pulse and to display it with significant accuracy, whereby the attending physician can determine accurately the width of the stimulating pulse and the state of the pacemaker's energy source. It is evident that the transmitter 10 may be a relatively portable unit that is adapted to be coupled to a telephone set, whereby the desired signals are transmitted over the telephone lines or transmission medium 50. At the end of the transmission medium 50, the receiver 60 is adapted to be coupled to another telephone set, whereby the transmitted signal may be converted to electrical signals within the receiver 60 to be processed and displayed as to be described in more detail.

In FIG. 1A, there is shown a simplified schematic of the transmitter 10, shown in block form in FIG. 1B. In particular, a pair of electrodes 11 is attached to the patient, as upon the inside of his forearms or legs, whereby the electrical activity of the patient's heart and the stimulating pulse as generated and applied to the patient by the implanted heart pacemaker, are detected and applied to an amplifier 12. The detected signal is amplified by the amplifier 12 before being applied to the EKG channel comprised of a filter 14 and a voltage controlled oscillator 18. The filter 14 serves to block the pacemaker stimulating pulses from the ECG channel. Further, the amplified signal is also applied to a pulse width detector 18 in accordance with the teachings of this invention, for providing an output sharply defining the pacer pulse width, and a pulse stretcher 20 whereby the detected pulse is stretched by a fixed factor, dependent upon the carrier signal to be transmitted along the transmission medium 50 to a display, e.g., a strip recorder, within the receiver 60, whereby the pulse width as displayed thereon does not mask other information of interest to the patient's doctor. Illustratively, the factor is selected to be within the range of 30-50 with a preferred value being in the order of 40. By selecting a multiplication factor in the noted range, the superimposed, multiplied pulse is of sufficient duration with respect to the frequency of the carrier signal, that no significant amount of the width of the stimulating pulse is lost. At the same time, even with a factor of 50, a pulse of normal width, e.g., 1.0 msec, as received and displayed by the receiver 60 does not unduly mask the other information as displayed at the remote station. The transmitter and receiver as generally shown in FIGS. 1A and 1B are more specifically described in U.S. Pat. No. 3,986,496 of Brastad, which is assigned to the assignee of this invention.

It is contemplated that in accordance with the teachings of this invention, that the pulse width of the pacer pulse may be accurately detected and then transmitted to the remote station at the physician's office where the physician or a trained technician may accurately observe the patient's heart activity as shown in FIG. 2. In FIG. 2 of the drawings, there is shown a typical graph of the electrical activity of a patient's heart which is stimulated by pulses derived from an artificial heart pacemaker. The heart activity or electrocardiogram (ECG) of the patient is indicated in FIG. 2 by the letter "B," whereas the stimulating pulse is identified by the letter "A," whose pulse width is indicated with the letters "PW." Noting that the threshold for stimulation of the heart varies from patient to patient, the minimum pulse width of the stimulating pulse is in the order of 100 .mu.sec and its minimum voltage amplitude is in the order of 0.5 V. Typically, the amplitude of the stimulating pulse would be in the order of 6 V.

Referring now to FIG. 3, there is shown an illustrative embodiment of the transmitter 10 generally shown in FIG. 1A and in particular an illustrative embodiment of the pulse width detector 18 in accordance with the teachings of this invention. The patient's ECG signals and the pacemaker pulse or artifact signals are sensed by a pair of electrodes 11 worn on the patient's arms and if utilized, an electrode 9 worn on the patient's right leg (or other location of the body) and applied to an input amplifier 12. The input amplifier 12 amplifies the input signals rejecting errors caused by common mode signals of large amplitudes that may be present. In a normal amplifier such common mode signals would tend to mask out the desired low level ECG and pacemaker pulse signals and even cause amplifier malfunctions such as saturation. The input amplifier 12 has a high input impedance, a low output impedance and typically greater than unity gain, for example, a gain of 2. The high input impedance is required because of the high source impedance which can occur between the electrodes 11 and the patient's skin. The signals via the electrode 9 are driven by an amplifier (not shown) that provides a sense common mode voltage to the input amplifier 12. Such a system is well known in the art and may take the form of a Hewlett-Packard driver lead EGC system. The input amplifier 12 provides a buffered, single ended output to the following signal processing circuit now to be described.

As apparent from FIG. 3, the buffered outputs are applied to the pulse width detector 18 wherein the pacemaker pulse or artifact signals are detected and whose pulse width is accurately determined, as well as to circuitry for amplifying and processing the ECG signals, now to be described. In particular the output of the input amplifier 12 is applied to an ECG amplifier 22 that converts the ECG wave form to current and provides a sufficient gain to realize the desired sensitivity of the current control oscillator 16. The gain of the ECG amplifier 22 is controlled by the setting of the potentiometer R2. The amplified ECG signal is applied to a CCO control circuit 24 that controls the mode of operation of the CCO. As seen in FIG. 3, an input is received from the pulse stretcher 20, which upon being rendered high, causes the CCO 16 to provide an output of selected frequency, e.g., 2250 Hz, for a period of time corresponding to the multiplied or stretched pulse width of the pacemaker pulse. The output of the CCO control circuit 24 is applied to the current control oscillator 16 which modulates the frequency of its output in accordance with the amplitude of the input current signal to provide an output that is amplified by an audio amplifier 19 to drive a transducer 21 in the form of a speaker. It is contemplated as shown in FIG. 1B, that the transducer 21 would be coupled to a telephone receiver, whereby the audio signals derived from the transducer 21 are reconverted to electrical signals to be transmitted over the medium 50 to the receiver 60. Further, there is included a timer 30 which automatically disconnects the power voltage as derived from a voltage regulator 28 from the remaining portions of the system to thereby terminate transmission of the patient's heart signals after a time sufficient to provide the physician an adequate sample thereof. Typically, this may be in the order of about 30 seconds. Further, there is included a low voltage inhibit circuit 26, which senses the power source potential to thereby disable the current control oscillator 16 when the voltage level of the power source falls below a desired level. In this regard, it is contemplated that the transmitter 10 may be a portable unit powered by a power source such as a battery. A capacitor bias amplifier 25 is coupled to the VCC regulator 28 to keep the voltage disposed across the capacitor C1 of the filter 14, which capacitor C1 is the low frequency cut off the ECG amplifier 22, as low as possible to avoid leakage effects from causing errors in the frequency of the output of the CCO 16. Further, the capacitor bias amplifier 25 also supplies a node that follows the voltage V.sub.CC as derived from the regulator 28 so that capacitors may be tied to it instead of ground, thereby to avoid inducing supply related transients across these capacitors.

As shown in FIGS. 1A and 3, the heart signals are applied from the input amplifier 12 also to the pulse width detector 18 and in particular to a differential amplifier circuit 34 to provide an output as seen in FIG. 4C. In this regard it is understood that the pacemaker pulse or artifact signal as derived from the input amplifier 12 generally resembles those as shown in FIG. 4A. It would be desired to have a well defined pacer pulse as shown in the time period from t1 to t2, but as explained above its wave shape is often degraded to appear as shown by that pulse appearing in FIG. 4A between times t3 and t5. The artifact signals are also applied to a wave shaping amplifier or differentiator circuit 32, whose output is shown in FIG. 4B. More specifically, the differentiator 32 responds to the leading edge appearing at either times t1 or t3 to provide a sharply rising spike on the positive going edge of the pacer pulse. The positive going spike is followed by a shelf which corresponds to the DC amplitude of the input pacer pulse as shown in FIG. 4A. It is noted that the amplitude X will vary from patient to patient, dependent upon the level of stimulation by the implanted pacemaker, as well as the efficiency of the electrical connection between the patient's body and input amplifier 12. At time t2 the differentiator circuit 32 provides a negative going spike corresponding to the trailing edge of the input pulse appearing at times t2 and t5. In the time period t3 to t5, a poor quality pacemaker pulse is sensed which may have a drop or fall of 80% within one millisecond. The differential amplifier 32 processes such an input pulse and provides an output as shown in FIG. 4B between the time period t3 and t4. It is noted that at t4, the wave form of FIG. 4B falls to a point slightly below the reference level and then resumes a shelf to time t5 at which time there is provided a negative going spike.

The heart activity signals including the pacing pulses are also applied to a first input of a differential amplifier circuit 34, while the output of the differentiator 32 is applied to a second input of the differential amplifier 34. Essentially, the differential amplifier 34 amplifies the difference of these two signals, thus removing the DC level component as shown in FIG. 4B of the differentiator output, to provide an output as shown in FIG. 4C. The amplifier output including a first spiked signal indicative of the leading edge of the pacing pulse and a second spiked signal indicative of the trailing edge of the pacer pulse, is applied to a leading edge detector or first threshold level circuit 36, which provides an output upon its line D when the first spiked signal appearing at t1 is positive going and exceeds a predetermined positive level, and an output upon its E line when the first spiked signal is negative going and exceeds a negative, similar level.

It is noted that the input pacemaker pulses may be either negative or positive going; therefore the leading edge detector 36 is capable of detecting negative and positive going spikes of a similar predetermined level. The outputs on the D and E lines are applied to a gate 38 that is normally enabled to pass these signals to an OR gate 40 to set a one shot multiplier 42, and to a leading edge flip-flop 44 to set the flip-flop 44 if a positive going leading edge is detected and to reset the flip-flop 44 if a negative leading edge is detected. The outputs of the leading edge detector 36 are respectively shown in FIGS. 4D and 4E.

As shown in FIG. 3, the output of the one shot multiplier 42 is also applied to enable a second, normally disabled gate 52 to initiate the detection and processing of the second spiked signal corresponding to the trailing edge of the pacemaker pulse. The output of the differentiator circuit 32, as shown in FIG. 4B, is applied to a limiter circuit or amplifier 48, which functions to amplify this input with a selective gain and to apply the amplified wave forms similar to that shown in FIG. 4B to a pulse width detector or second threshold circuit 51. The pulse width detector 51 detects positive and negative going trailing edges to provide upon its output lines F and G, respectively, signals if the amplitude of the input spikes exceed a predetermined level.

In operation, a pacemaker pulse as shown in FIG. 4A is applied to each of the first and second differential circuits 34 and 32 respectively. Considering first the detection of the leading edge as occurs at time t3, the differentiator circuit 32 provides an output as shown in FIG. 4B that is applied along with the pacemaker pulse to the inputs of the differential amplifier circuit 34 to provide an output as shown in FIG. 4C. The differential circuit 34 in a sense removes the DC component notably the shelf between the positive and negative going spikes to provide an output as shown in FIG. 4C. If as shown in FIG. 4C, the initial spiked signal is positive going, the leading edge detector 36 provides an output signal upon its D line if the amplitude of the positive going spike is above its threshold level. Assuming so, the signal on the D line is passed by the first gate 38 and applied via the OR gate 40 to set the one shot multiplier 42, thereby inhibiting the first gate 38 and enabling the second gate 52. At the same time, the output of the first gate 38 is applied to set the leading edge flip-flop 44 whereby its Q output goes high. Conversely, it may be understood that if the leading edge of the pacemaker pulse and therefore the initial spiked signal as derived from the differential amplifier 34 is negative going, an output is provided on the E line and applied to reset the leading edge flip-flop 44, driving its Q output negative.

At a point in time between t3 and t5, the second gate is been enabled, permitting the passage of signals to a pulse width flip-flop 54. Assuming that the output of the second differentiator circuit 32 is as shown in FIG. 4B, i.e., the trailing edge is a negative going signal, that negative signal is amplified by the limiter 48 and applied to the pulse width detector 51, whereby if the amplitude of the negative going spike is above the threshold level of the pulse width detector 51, an output is developed upon its G line and applied via the enabled second gate 52 to reset the pulse width flip-flop 54, thereby driving its Q output negative. Thus, it is seen that at the time t3 when a positive going spike appears, a high signal is applied from the flip-flops 44 and 54 to the inputs of the exclusive NOR gate 46, which then provides a high output. When as in the example discussed above, the trailing edge is evidenced by the negative going spike of FIG. 4B at time t5, the flip-flop 54 is reset driving the exclusive NOR gate 46 low. Thus, the NOR gate 46 provides a sharply defined output as shown in FIG. 4H going high at time t3 and going low at time t5, thereby defining the leading and trailing edges of the pacemaker pulse.

As shown in FIGS. 1A and 3, the output pulses of FIG. 4H are applied from the exclusive NOR gate 46 to the pulse stretcher 20 to be multiplied or stretched by a given factor before being applied to the CCO controller 24, whereby the current control oscillator 16 is disposed into its mode of operation where it generates a signal of fixed frequency for a period corresponding to the pulse width of the pacemaker pulse. As indicated above, with respect to FIG. 1B, this signal may be transmitted via the transmission medium 50 to a receiver 60, whereat it is detected and suitably displayed for the benefit of the physician or his technician.

Referring now to FIGS. 6A, B and C, there is shown detailed drawings of the circuit elements making up the block diagrams more generally shown in FIG. 3. Each of the block diagrams shown in FIG. 3 will now be discussed below with regard to FIGS. 6A, 6B and 6C.

A significant aspect of this invention resides in accurately detecting an attenuated pacer pulse as seen in FIG. 4A by separately sensing and processing the leading and trailing edges of the pulse, while taking particular precautions not to sense the droop or attenuated waveform portion of the pulse between the leading and trailing edges, which otherwise might provide a false, premature indication of the trailing edge. To this end, the characteristics and parameters of the elements of the pulse width detector 18 and in particular the differential amplifier 34, the differentiator or wave shaping amplifier 32, the limiter or amplifier 48, and the threshold detectors 36 and 51 are critically selected. As shown i