Autocapture system for implantable pulse generator

• US 5,350,410 A
• Filed: 11/23/1992
• Issued: 09/27/1994
• Est. Priority Date: 11/23/1992
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Wilson, Raymond J., Poore, John W., Mann, Brian M., Kleks, Jonathan A., Buchanan, Stuart W.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US07/980,941
• Time in Patent Office: 673 Days
• Field of Search: 607/28, 607/27, 607/13, 607/11
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3716 with reduction of residual polarisation effects

Abstract

An autocapture system within an implantable pulse generator automatically maintains the energy of a stimulation pulse at a level just above that which is needed to effectuate capture. The electrical post-stimulus signal of the heart following delivery of a stimulation pulse is compared to a polarization template, determined during a capture verification test. A prescribed difference between the polarization template and the post-stimulus signal indicates capture has occurred. Otherwise, loss of capture is presumed, and a loss-of-capture routine is invoked that increases the energy a prescribed amount to obtain capture. Periodically, and/or at programmed intervals or events, the capture verification test is performed. During the capture verification test, the pulse generator determines a polarization template for a particular stimulation energy and for each of a plurality of sensitivity or threshold settings. A determination is also made as to which sensitivity settings yield capture. An autocapture routine extends the capture verification test data to a wide range of stimulation energies. An autothreshold routine automatically sets the energy of the stimulation pulse a specified level above the energy at which capture is first lost.

Claims

1. A system for detecting capture in an implantable pulse generator on a beat-by-beat basis, the implantable pulse generator being coupled to an implantable stimulation lead in contact with the heart, the system comprising:

pulse generating means for generating stimulation pulses at a desired stimulation pulse energy;

sensing means, coupled to the stimulation lead, for sensing cardiac signals and for sensing post-stimulation signals which occur following each stimulation pulse, the sensing means including means for sensing first and second post-stimulation signals at each of a plurality of sensitivities, the first post-stimulation signals corresponding to polarization signals sensed at each of a plurality of sensitivities;

means for comparing the first and second post-stimulation signals at each respective sensitivity and producing as an output a plurality of difference signals, presence of a prescribed difference signal indicating that the heart was captured by the stimulation pulse;

means for determining an optimum sensitivity setting based on the prescribed difference signal, and for biasing the sensing means to the optimum sensitivity setting for stimulation pulses subsequently generated at the desired stimulation pulse energy; and

processing means for comparing post-stimulation signals sensed by the sensing means at the optimum setting with the respective polarization signal, whereby a prescribed difference signal sensed by the sensing means at the optimum sensitivity setting is used for capture detection on a beat-by-beat basis.

2. The system for detecting capture, as set forth in claim 1, wherein:

the pulse generating means includes means for generating stimulation pulses at a plurality of stimulation pulse energies;

the sensing means senses each of the first and second signals at each of the plurality of sensitivities at each of the plurality of stimulation pulse energies; and

the determining means determines the optimum sensitivity setting for each of the plurality of stimulation pulse energies based on the occurrence of the prescribed difference signal.

3. The system for detecting capture, as set forth in claim 2, further comprising:

means for detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost;

adjusting means for repeatedly increasing the energy of the stimulation pulse in prescribed energy steps until the presence of the prescribed difference signal is found indicating that the heart was captured by the stimulation pulse and for adding a prescribed safety margin thereto; and

means for changing the sensitivity setting of the sensing means to the optimum sensitivity setting determined by the determining means for stimulation pulses subsequently generated by the pulse generating means.

4. The system for detecting capture, as set forth in claim 2, further comprising:

adjusting means for repeatedly decreasing the energy of the stimulation pulse in prescribed energy steps;

means for changing the sensitivity setting of the sensing means to the optimum sensitivity setting determined by the determining means for each energy step; and

means for detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost, whereupon the adjusting means increases the stimulation energy by a prescribed safety margin.

5. The system for detecting capture, as set forth in claim 1, wherein the sensing means comprises:

a comparator which has as an output a first value if the magnitude of the post-stimulation signal is less than a prescribed reference value, and a second value if the magnitude of the post-stimulation signals is greater than the prescribed reference value.

6. The system for detecting capture, as set forth in claim 5, wherein the sensing means further comprises:

means for sampling the output of the comparator at least eight times during a prescribed sampling window following the delivery of the stimulation pulse to the heart, the sampling means producing as an output a digital signature having at least eight bits, with each bit of the digital signature corresponding to the value of the output of the comparator at a different sampling time.

7. The system for detecting capture, as set forth in claim 6, wherein the prescribed difference signal comprises a difference signal having a maximum number of bits.

8. The system for detecting capture, as set forth in claim 7, wherein the desired stimulation pulse energy has associated therewith a plurality of prescribed difference signals which have an equal number of bits, the determining means further comprising:

means for analyzing the plurality of prescribed difference signals which have the equal number of bits and for selecting as the optimum sensitivity setting that setting which corresponds to the highest sensitivity setting.

9. The system for detecting capture, as set forth in claim 7, wherein the prescribed difference signal comprises at least three bits.

10. The system for detecting capture, as set forth in claim 1, further comprising:

means for stimulating the heart with a first and a second stimulation pulse separated in time by an interval less than a refractory period of the heart, the first stimulation pulse having a stimulation energy sufficient to capture the heart, the second stimulation pulse having the desired stimulation pulse energy; and

wherein the sensing means includes means for sensing a post-stimulation signal in response to the second pulse at each of the plurality of sensitivities, the post-stimulation signals sensed in response to the second pulse corresponding to the first post-stimulation signal sensed at each of the plurality of sensitivities.

11. The system for detecting capture, as set forth in claim 10, wherein the sensing means includes means for digitizing the first post-stimulation signal in response to the second stimulation pulse, and for digitizing the second post-stimulation signal in response to the desired stimulation pulse.

12. The system for detecting capture, as set forth in claim 11, wherein the digitizing means includes:

means for defining a multi-bit word, each bit of the multi-bit word indicating whether the magnitude of the post-stimulation signal is greater or less than a prescribed threshold at a particular sample time following the delivery of the stimulation pulse to the heart, a first multi-bit word being thus formed comprising the first post-stimulation signal, and a second multi-bit word being thus formed in response to the second post-stimulation signal.

13. The system for detecting capture, as set forth in claim 12, wherein the means for comparing the first and second post-stimulation signals at each respective sensitivity includes means for comparing corresponding bits of the first and second multibit words and indicating capture only when at least a prescribed number of the bits are different.

14. The system for detecting capture, as set forth in claim 13, wherein the first and second multi-bit words each include at least eight bits, and wherein the number of bits that must be different between the first and second multi-bit words in order to indicate capture comprises at least three.

15. The system for detecting capture, as set forth in claim 12, wherein the means for digitizing the sensed post-stimulus signal includes:

means for sampling the magnitude of the first and second sensed post-stimulus signals at a plurality of sample times and representing the sampled magnitude as a digital word having a plurality of bits at each sample time, a first digital word being formed from sampling the sensed post-stimulus signal at a first sample time, a second digital word being formed from sampling the sensed post-stimulus signal at a second sample time, and so on, with a digital signature being formed that comprises the combination of all of the digital words from all of the sample times, the digital signature being representative of the digitized sensed post-stimulus signal;

whereby a first post-stimulus signature is formed by digitizing the first post-stimulus signal following delivery of the second stimulation pulse and the second post-stimulus signal following delivery of the desired stimulation pulse.

16. The system for detecting capture, as set forth in claim 15, wherein the means for comparing the first and second post-stimulus signals comprises comparing the first post-stimulus signal signature with the second post-stimulation signal on a digital word by digital word basis, and indicating capture only when a prescribed difference exists between a prescribed number of the digital words.

17. An autocapture system for use within an implantable pulse generator, comprising:

means for stimulating the heart with a stimulation pulse at each of a plurality of stimulation energies;

sensing means for sensing cardiac signals and for sensing post-stimulation signals which occur following each stimulation pulse, the post-stimulation signals being sensed at each of a plurality of sensitivity settings for each of the plurality of stimulation energies;

means for defining a plurality of polarization templates corresponding to the plurality of post-stimulation signals;

processing means for comparing the plurality of post-stimulation signals with the corresponding polarization template and indicating capture if a prescribed difference exists therebetween, and for determining an optimal sensitivity setting for the sensing means for each of the plurality of stimulation energies based on the existence of the prescribed difference signal;

means for biasing the sensing means at the optimum sensitivity setting for stimulation pulses subsequently generated at a desired stimulation pulse energy; and

wherein the processing means compares the post-stimulation signal sensed by the sensing means at the optimum sensitivity setting to the corresponding polarization template for beat-by-beat capture detection, whereby the presence of the prescribed difference signal at the optimum sensitivity setting indicates whether capture has occurred.

18. The autocapture system, as set forth in claim 17, further comprising:

means for detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost;

adjusting means for repeatedly increasing the energy of the stimulation pulse in prescribed energy steps until the presence of the prescribed difference signal is found indicating that the heart was captured by the stimulation pulse and for adding a prescribed safety margin thereto; and

means for changing the sensitivity setting of the sensing means to the optimum sensitivity setting determined by the processing means for the stimulation pulses subsequently generated by the pulse generating means.

19. The autocapture system, as set forth in claim 17, further comprising:

adjusting means for repeatedly decreasing the energy of the stimulation pulse in prescribed energy steps;

means for changing the sensitivity setting of the sensing means to the optimum sensitivity setting determined by the processing means for each energy step; and

means for detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost, whereupon the adjusting means increases the stimulation energy by a prescribed safety margin.

20. The autocapture system, as set forth in claim 17, wherein the means for defining the plurality of polarization templates comprises:

means for stimulating the heart with a first and a second stimulation pulse separated in time by an interval less than a refractory period of the heart, the first stimulation pulse having a stimulation energy sufficient to capture the heart, the second stimulation pulse having the desired stimulation energy;

wherein the sensing means includes means for sensing a post-stimulation signal in response to the second pulse at the plurality of sensitivities, the post-stimulation signals sensed in response to the second pulse being the plurality of polarization templates.

21. A method for detecting capture in an implantable pulse generator, the method comprising the steps of:

generating stimulation pulses at a desired stimulation pulse energy;

sensing cardiac signals and post-stimulation signals which occur following each stimulation pulse with a sense amplifier, the post-stimulation signals including first and second post-stimulation signals at each of a plurality of sensitivities, the first post-stimulation signals corresponding to polarization signals sensed at each of a plurality of sensitivities;

comparing the first and second post-stimulation signals at each respective sensitivity and producing as an output a plurality of difference signals, presence of a prescribed difference signal indicating that the heart was captured by the stimulation pulse;

determining an optimum sensitivity setting based on the prescribed difference signal;

biasing the sense amplifier to the optimum sensitivity setting for stimulation pulses subsequently generated at the desired stimulation pulse energy; and

comparing post-stimulation signals sensed at the optimum setting with the respective polarization signal, whereby a prescribed difference signal sensed by the sensing means at the optimum sensitivity setting is used for capture detection on a beat-by-beat basis.

22. The method, as set forth in claim 21, further comprising the steps of:

generating stimulation pulses at a plurality of stimulation pulse energies;

sensing each of the first and second post-stimulation signals at each of the plurality of stimulation pulse energies; and

determining the optimum sensitivity setting for the sensing means for each of the plurality of stimulation pulse energies based on the occurrence of the prescribed difference signal.

23. The method, as set forth in claim 21, wherein the defining step comprises the steps of:

stimulating the heart with a first stimulation pulse having a stimulation energy sufficient to capture the heart;

stimulating the heart with a second stimulation pulse having a desired stimulation energy during a refractory period of the heart; and

sensing post-stimulation signals in response to the second pulse at each of the plurality of sensitivities corresponding to the polarization signals at each of the plurality of sensitivities.

24. The method, as set forth in claim 21, further comprising the steps of:

detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost;

repeatedly increasing the energy of the stimulation pulse in prescribed energy steps until the presence of the prescribed difference signal is found indicating that the heart was captured by the stimulation pulse; and

changing the sensitivity setting of the sensing means to the optimum sensitivity setting for stimulation pulses subsequently generated.

25. The method, as set forth in claim 21, further comprising the steps of:

repeatedly decreasing the energy of the stimulation pulse in prescribed energy steps using an adjusting means;

changing the sensitivity setting of the sensing means to the optimum sensitivity setting determined by the determining means for each energy step; and

detecting when the prescribed difference signal no longer exists, the absence of the prescribed difference signal indicating that capture has been lost, whereupon the adjusting means increases the stimulation energy by a prescribed safety margin.

26. A method for determining capture within an implantable pulse generator, the implantable pulse generator including stimulation means for generating a stimulation pulse at a selectable stimulation energy and delivering the stimulation pulse to a heart, and sensing means for sensing a post-stimulus signal from the heart at a selectable sensitivity following delivery of the stimulation pulse, the method comprising the steps of:

(a) defining a plurality of polarization templates for a selected stimulation energy of the stimulation means and for a plurality of sensitivity settings of the sensing means;

(b) stimulating the heart with a stimulation pulse having the selected stimulation energy;

(c) sensing a plurality of post-stimulus signals at the selected stimulation energy with the sensing means at each of the plurality of sensitivity settings;

(d) comparing the polarization template with the post-stimulus signal and indicating capture if a prescribed difference signal exists therebetween; and

(e) determining an optimum sensitivity setting for the sensing means based on the prescribed difference signal.

27. The method for determining capture, as set forth in claim 26, wherein step (a) comprises:

(1) stimulating the heart with a pair of stimulation pulses separated in time by an interval less than a refractory period of the heart, a first pulse of the pair of stimulation pulses having a stimulation energy sufficient to capture the heart, a second pulse of the pair of stimulation pulses having the selected stimulation energy;

(2) sensing the post-stimulus signal from the heart in response to the second pulse at each of the plurality of sensitivity settings; and

(3) defining the polarization template as the post-stimulus signal sensed in step (2).

28. The method for determining capture, as set forth in claim 26, further comprising the steps of:

(f) digitizing the plurality of sensed post-stimulus signals at the selected stimulation energy; and

(g) digitizing the plurality of sensed post-stimulus signal obtained from the second pulse of the pulse pair.

29. The method for determining capture, as set forth in claim 28, wherein the steps of digitizing the sensed post-stimulus signals in steps (f) and (g) comprises:

defining a multibit word, each bit of the multibit word indicating whether the magnitude of the post-stimulus signal was greater or less than a prescribed threshold at a particular sample time following the delivery of the stimulation pulse to the heart, a first multibit word being thus formed representing the post-stimulus signal at the selected stimulation energy, and a second multibit word being thus formed representing the polarization template.

30. The method for determining capture, as set forth in claim 29, wherein step (d) comprises comparing corresponding bits of the first and second multibit words and indicating capture only when at least a prescribed number of the bits are different.

31. The method for determining capture, as set forth in claim 30, wherein the first and second multibit words each include at least eight bits, and wherein the number of bits that must be different between the first and second multibit words comprises at least three.

32. The method for determining capture, as set forth in claim 28, wherein the step of digitizing the sensed post-stimulus signal comprises sampling the magnitude of the sensed post-stimulus signal at a plurality of sample times and forming a digital word having a plurality of bits at each sample time, a first digital word being formed from sampling the sensed post-stimulus signal at a first sample time, a second digital word being formed from sampling the sensed post-stimulus signal at a second sample time, and so on, with a digital signature being formed that comprises the combination of all of the digital words from all of the sample times;

the digital signature being representative of the digitized sensed post-stimulus signal;

a first digital signature being formed by thus digitizing the post-stimulus signal following delivery of the stimulation pulse, the first digital signature comprising an post-stimulus signal signature; and

a second digital signature being formed by thus digitizing the post-stimulus signal following delivery of the second stimulation pulse of the pair of stimulation pulses, the second digital signature comprising a polarization template signature.

33. The method for determining capture, as set forth in claim 32, wherein step (d) comprises comparing the post-stimulus signal signature with the polarization template signature and indicating capture only when a prescribed difference exists therebetween.

34. The method for determining capture, as set forth in claim 33, wherein the comparison of the post-stimulus signal signature to the polarization template signature comprises comparing the signatures on a digital word by digital word basis, and indicating capture only when a prescribed difference exists between a prescribed number of the digital words.