Implantable Medical Device with Heart Condition Detection

• US 20080306566A1
• Filed: 12/16/2005
• Published: 12/11/2008
• Est. Priority Date: 12/16/2005
• Status: Active Grant

• Current Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Inventors: Noren, Kjell, Holmstrom, Nils
• Granted Patent: US 8,133,187 B2
• Time in Patent Office: Days
• US Class Current: 607/19
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone

Abstract

A method for detecting a condition of a heart of a patient using an implantable medical device including the steps of sensing acoustic signals indicative of heart sounds of the heart of the patient; extracting signals corresponding to a first heart sound (S1) and a second heart sound (S2) from sensed signals; calculating an energy value corresponding to a signal corresponding to the first heart sound (S1) and an energy value corresponding to the second heart sound (S2); calculating a relation between the energy value corresponding to the first heart sound and the energy value corresponding to the second heart sound for successive cardiac cycles; and using at least one relation to detect the condition or a change of the condition. A medical device for determining the posture of a patient and a computer readable medium encoded with instructions are used to perform the inventive method.

Claims

1-46. -46. (canceled)

47. An implantable medical device for detecting a condition of a heart of a patient, said device comprising:

a pulse generator that emits cardiac stimulating pacing pulses;

a lead comprising at least one electrode, said lead being connected to said pulse generator and being configured for implantation in the patient to deliver said cardiac stimulating pacing pulses to cardiac tissue in the patient,

an acoustic sensor configured to sense acoustic energy in the patient, said acoustic sensor emitting an acoustic sensor signal indicative of heart sounds produced by the heart of the patient;

a signal processor connected to said acoustic sensor configured to extract signal components from said acoustic sensor signal respectively corresponding to a first heard sound (S1) and a second heart sound (S2) over predetermined periods of a cardiac cycle during successive cardiac cycles, and to calculate a first energy value corresponding to said first heart sound (S1) and a second energy value corresponding to said second heart sound (S2);

a storage unit in communication with said signal processor that stores said first and second energy values corresponding to said first and second heart sounds; and

a controller connected to said pulse generator, and configured to calculate a relation between said first energy value and second energy value for successive cardiac cycles, and to use said relation to identify a condition of the heart of the patient or a change of said condition of the heart of the patient, and to control emission of said cardiac stimulating pacing pulses from said pulse generator dependent on said condition or said change of said condition.

48. An implantable medical device as claimed in claim 47 wherein said controller is configured to compare said relation with at least one preceding relation to identify said condition or said change of said condition.

49. An implantable medical device as claimed in claim 47 wherein said signal processor is configured to calculate said first energy value as a mean value over a predetermined number of successive first energy values corresponding to successive first heart sounds and to calculate said second energy value as a mean value over a predetermined number of successive second energy values corresponding to successive second heart sounds, and wherein said controller is configured to calculate a further relation between a maximum amplitude of said first heart sound (S1) and a maximum amplitude of said second heart sound (S2) of a cardiac cycle for successive cardiac cycles, and to compare a present further relation with at least one preceding further relation, to obtain a comparison result, and to use said comparison result in addition to said relation between said first and second energy values to detect said condition or said change of said condition.

50. An implantable medical device as claimed in claim 47 wherein said controller calculates said first energy value as a mean value over a predetermined number of successive first energy values corresponding to successive first heart sounds and to calculate said second energy value as a mean value over a predetermined number of successive second energy values corresponding to successive second heart sounds, and to calculate said relation as a mean value of relations over a predetermined number of successive relations corresponding to said successive first and second heart sounds.

51. An implantable medical device as claimed in claim 50 wherein said controller is configured to detect said condition or said change of said condition as a condition selected from the group consisting of heart insufficiency, systemic hypertension, pulmonary hypertension, myocardial ischemia, increased cardiac output, and increased stress level.

52. An implantable medical device as claimed in claim 47 wherein said controller is configured to compare a present first energy value with a preceding first energy value, and to compare a present second energy value with a preceding second energy value to calculate said relation.

53. An implantable medical device as claimed in claim 47 wherein said signal processor comprises a component that extracts said signal components respectively corresponding to said first heart sound (S1) and said second heart sound (S2), said component being selected from the group consisting of:

a determining unit that determines said component corresponding to said first heart sound (S1) as being above a first amplitude level of said acoustic sensor signal, and that determines said component corresponding to said second heart sound (S2) as being above a second amplitude level of said acoustic sensor signal; and

an integrator that integrates said acoustic sensor signal during a first predetermined time window to obtain said first energy value as an integration result, and that integrates said acoustic sensor signal during a second predetermined time window to obtain said second energy value as an integral result.

54. An implantable medical device as claimed in claim 47 wherein said signal processor comprises:

a bandpass filter that filters out frequency components of said acoustic sensor signal outside of a predetermined frequency range, to obtain a filtered signal;

a positive/zero value generator selected from the group consisting of a rectifier that rectifies said filter signal to produce signals containing only positive values or zero values, and a squaring circuit that performs a squaring of said filtered signal to produce a signal containing only positive values or zero values;

an identifying circuit configured to identify at least one first local maximum point coincident with said first heart sound signal (S1) and at least one second local maximum point coincident with said second heart sound signal (S2); and

an integrator that integrates said signal containing only positive values or zero values from said positive/zero value generator in a predetermined time window comprising said at least one first local maximum point to obtain said first energy value as an integration result, and that integrates said signal containing only positive values or zero values from said positive/zero value generator in a predetermined time window comprising said at least one second local maximum point to obtain said second energy value as an integration result.

55. An implantable medical device as claimed in claim 47 comprising:

a position detector configured to detect a body position of the patient, represented in a position detector output signal; and

said controller being supplied with said position detector output signal and being configured to determine, from said position detector output signal, patient information indicating whether said patient is in at least one predetermined body position, and to use said position information, in addition to said relation, to determine said condition or said change of said condition, and to synchronize sensing by said acoustic sensor with said patient being in said predetermined body position.

56. An implantable medical device as claimed in claim 47 comprising:

an activity level sensor that senses an activity level of the patient, and that emits an activity level signal corresponding to said activity level; and

said controller being supplied with said activity level signal and being configured to determine whether said activity level is below a predetermined activity level or to determine whether said activity level is below a predetermined first activity level or within an activity level range between a second activity level and a third activity level, and to synchronize sensing by said acoustic sensor dependent on whether the sensed activity level is below said predetermined activity level, or within said activity level range.

57. An implantable medical device as claimed in claim 47 comprising:

a heart rate sensor that senses a heart rate of the patient, and that emits a heart rate signal representing said heart rate; and

said controller being supplied with said heart rate signal and being configured to determine whether said heart rate is within a predetermined heart rate range, as heart rate information, and to use said heart rate information, in addition to said relation, to detect said condition or said change of said condition.

58. An implantable medical device as claimed in claim 47 wherein said acoustic sensor is located at a location selected from the group consisting of at a housing of said device, at a lead of said device configured for placement in a ventricle of the heart, at a lead of said device configured for placement in a coronary vein of the heart, and wherein said acoustic sensor is a sensor selected from the group consisting of accelerometers, pressure sensors and microphones.

59. A method for detecting a condition of a heart of a patient using an implantable medical device, comprising the steps of:

sensing an acoustic energy in the patient to obtain a sensed signal indicative of heart sounds of the patient over predetermined periods of a cardiac cycle during successive cardiac cycles;

in said implantable medical device, extracting signal components from said sensed signal respectively corresponding to a first heart sound (S1) and a second heart sound (S2) of a cardiac cycle;

in said implantable medical device, calculating a first energy value corresponding to said first heart sound (S1 and a second energy value corresponding to said second heart sound (S2);

in said implantable medical device, storing said first and second energy values; and

in said implantable medical device, calculating a relation between said first energy value and said second energy value and, dependent on said relation detecting said condition or a change of said condition.

60. A method as claimed in claim 59 comprising comparing a present relation with at least one preceding relation to detect said condition or said change of said condition.

61. A method as claimed in claim 59 comprising calculating, as said relation, a relation between a maximum amplitude of said first energy value and a maximum amplitude of said second energy value.

62. A method as claimed in claim 59 comprising calculating said first energy value as a mean value over a predetermined number of successive first energy values corresponding to successive first heart sounds and calculating said second energy value as a mean value over a predetermined number of successive second energy values corresponding to successive second heart sounds, and comprising calculating said relation as a mean value over said predetermined number of successive first and second energy values.

63. A method as claimed in claim 59 comprising from said relation, detecting said condition or said change of said condition as a condition selected from the group consisting of heart insufficiency, systemic hypertension, pulmonary hypertension, myocardial ischemia, increased cardiac output, and increased stress level.

64. A method as claimed in claim 59 comprising calculating said relation by comparing a present first energy value to a preceding first energy value and comparing a present second energy value to a preceding second energy value.

65. A method as claimed in claim 59 comprising extracting said component corresponding to said first heart sound (S1) from said sensed signal as having an amplitude above a predetermined first amplitude level, and extracting said component corresponding to said second heart sound (S2) from said sensed signal as being above a predetermined second amplitude level, and calculating said first energy value by integrating said component corresponding to said first heart sound (S1) during a predetermined first time window, and calculating said energy value by integrating said component corresponding to said second heart sound (S2) over a predetermined second time window.

66. A method as claimed in claim 59 comprising calculating said relation by:

filtering out frequency components of said sense signal outside of a predetermined frequency range, to obtain a filtered signal;

producing signals containing only positive or zero values by rectifying said filtered signal or by squaring said filtered signal;

identifying at least one first local maximum point coincident with said first heart sound (S1) and identifying at least one second local maximum point coincident with said second heart sound (S2); and

integrating said component corresponding to said first heart sound (S1) in a predetermined time window comprising said at least one first local maximum point to obtain said first energy value as an integration result, and integrating said component corresponding to said second heart sound (S2) in a predetermined time window comprising said at least one second local maximum point to obtain said second energy value as an integration result.

67. A method as claimed in claim 59 comprising:

detecting at least one body position of the patient;

determining when said patient is in said at least one predetermined body position; and

synchronizing sensing by said acoustic sensor to obtain said sensed signal when said patient in said predetermined body position.

68. A method as claimed in claim 59 comprising:

sensing an activity level of the patient;

determining whether the activity level is below predetermined activity level or whether said activity level is below a predetermined first activity level or within an activity level range between a second activity level and third activity level; and

synchronizing sensing of said acoustic signal dependent on whether said activity level is below said predetermined activity level or said sensed activity level is within said activity level range.

69. A method as claimed in claim 59 comprising:

sensing a heart rate of the patient;

determining whether said heart rate is within a predetermined heart rate range; and

if said heart rate is within said predetermined heart rate range, calculating said relation.

70. A method as claimed in claim 59 comprising detecting said acoustic signal from a location selected from the group consisting of at a housing said implantable medical device, in a right ventricle of the heart, and in a coronary vein of the heart and sensing said acoustic signal with an acoustic sensor selected from the group consisting of accelerometers, pressure sensors, and microphones.

71. A computer-readable medium encoded with programming instructions for operating an implantable medical device to cause said implantable medical device to:

sensed an acoustic energy in the patient to obtain a sensed signal indicative of heart sounds of the patient over predetermined periods of a cardiac cycle during successive cardiac cycles;

in said implantable medical device, extract signal components from said sensed signal respectively corresponding to a first heart sound (S1) and a second heart sound (S2) of a cardiac cycle;

in said implantable medical device, calculate a first energy value corresponding to said first heart sound (S1 and a second energy value corresponding to said second heart sound (S2);

in said implantable medical device, store said first and second energy values; and

in said implantable medical device, calculate a relation between said first energy value and said second energy value and, dependent on said relation detecting said condition or a change of said condition.