Implantable haemodynamically responsive cardioverting/defibrillating pacemaker

An implantable device for the treatment of malfunctions of a patient's heart, said device including a first sensing means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, a second sensing means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a right ventricular filtered-peak-to-peak pressure amplitude, "RVFPPA", or a right ventricular peak pressure function, "RVPPF", analyzing means primarily responsive to the signal from one of said sensing means for analyzing the state of the heart's function and providing any required electrical shock therapy to the heart, detecting means for detecting uncertainty in regard to the therapy to be provided to the heart by said analyzing means, and controlling means responsive to said uncertainty and operative to change the primary responsiveness of said analyzing means to the signal provided by the other of said sensing means for controlling the therapy that is to be provided to the heart, said one of said sensing means being said first sensing means and said other of said sensing means being said second sensing means, said device further including means for comparing the level of either RVFPPA or RVPPF with a first predetermined threshold index thereof and detecting crossings of said threshold, and wherein said first signal comprises an electrically derived ECG heart rate and said second signal is representative of a right ventricular pressure waveform of the heart, wherein the state of the heart's function is determined from information derived from said second signal when there is uncertainty in the electrical diagnosis of said state, and wherein said analyzing means analyzes the state of the heart's function during periods of such uncertainty based on a comparison of the level of either RVFPPA or RVPPF with said first predetermined threshold index thereof, and (i) provides no therapy if said first threshold index is crossed repeatedly by said level within a programmed interval, (ii) provides ATP therapy if said level does not cross said first threshold index repeatedly during said programmed interval but crosses a second predetermined threshold index repeatedly during said programmed interval, (iii) provides bradycardia support pacing therapy if said level does not cross said second predetermined threshold index repeatedly during said programmed interval, and (iv) provides defibrillation therapy if an evoked pressure response is not sensed in response to said bradycardia support pacing.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, and having a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether there is uncertainty in regard to a therapy to be provided to the heart and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of uncertainty in regard to the therapy to be provided as a result of said analysis, analyzing the other of said signals to decide n the electrical shock therapy to be provided to the heart, wherein said first signal comprises an electrically derived ECG heart rate, wherein said device is a cardioverting/defibrillating pacemaker implanted in the patient at a location remote from the patient's cardiac cavity, wherein said device is provided with sensing leads which interconnect the chambers of the patient's heart with respect to first and second electrical sensing circuits in the first and second sensing means of said device, wherein said electrical sensing circuits include corresponding sensing amplifiers, and wherein said method further includes the steps of:
• periodically assessing the impedance of the ECG sensing leads to insure that it is within predetermined limits;
• periodically assessing the amplitude of the amplified ECG signal outputted by the ECG sensing amplifier and adjusting the gain of said sensing amplifier to ensure that said output of said amplifier is maintained within predetermined limits;
• and, establishing that the patient's heart is in a state of normal function both before and during the adjustment of the gain of the ECG sensing amplifier by relying on haemodynamic heart function information obtained from said second signal.

A method of treating malfunctions of patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, and having a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether there is uncertainty in regard to a therapy to be provided to the heart and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of uncertainty in regard to the therapy to be provided as a result of said analysis, analyzing the other of said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is a cardioverting/defibrillating pacemaker implanted in the patient at a location remote from the patient's cardiac heart cavity, wherein said device is provided with ventricular pressure, "VP", sensing leads which interconnect chambers of the patient's heart with respect to first and second electrical sensing circuits in the first and second sensing means of said device, wherein said electrical sensing circuits include corresponding sensing amplifiers, and wherein said method further includes the steps of:
• periodically assessing the impedance of the VP sensing leads to ensure that it is within predetermined limits;
• periodically assessing the amplitude of the amplified VP signal outputted by the VP sensing amplifier and adjusting the gain of said sensing amplifier to ensure that said output of said amplifier is maintained within predetermined limits;
• and establishing that the patient's heart is in a state of normal function both before and during the adjustment of the gain of the VP sensing amplifier by relying upon ECG heart function information obtained from said first signal.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, and having a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine where there is uncertainty in regard to a therapy to be provided to the heart and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of uncertainty in regard to the therapy to be provided as a result of said analysis, analyzing the other of said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is a cardioverting/defibrillating pacemaker, wherein said second signal is representative of the right ventricular pressure waveform of the heart, wherein the state of the heart's function is derived from said second signal when there is an uncertainty in the diagnosis of said state as derived from said first signal, and wherein said method further includes the steps of:
• analyzing the state of the heart's function during periods of such uncertainty based on a comparison of the level of either right VFPPA or right VPPF with a first predetermined threshold index thereof, and (i) providing no therapy if said first threshold index is crossed repeatedly by said level within a programmed interval, (ii) providing ATP therapy if said level does not cross said first threshold index repeatedly during said programmed interval but crosses a second predetermined threshold index repeatedly during said programmed interval, (iii) providing bradycardia support pacing therapy if said level does not cross said second predetermined threshold index repeatedly during said programmed interval, and (iv) providing defibrillation therapy if an evoked pressure response is not sensed in response to said bradycardia support pacing.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, and having a second means for sensing a haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising one or another of a ventricular filtered peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether there is uncertainty in regard to a therapy to be provided to the heart and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of uncertainty in regard to the therapy to be provided as a result of said analysis, analyzing the other of said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is implanted in the patient at a location remote from the patient's cardiac cavity, wherein said device is provided with sensing leads which interconnect chambers of the patient's heart with electrical sensing circuits in the first and second sensing means of said device, and wherein said method further includes the steps of checking that the impedance of said ECG sensing leads is within predetermined limits and, if it is not, then determining whether or not pacing is still possible by applying a short train of pacing pulses at a preprogrammed rate and checking for ventricular pressure responses thereto;
• if pacing is determined to still be possible, altering control of the device so that it relies solely upon pressure derived information to determine the state of the heart's function;
• and, providing a warning signal to alert the patient or his attending physician of a system failure.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered-peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether a malfunction exists in the sensing means which provides said one of said signals and decide on any required electrical shock therapy to be provide to the heart;
• and, in the event of a malfunction in the sensing means which provides said one of said signals, analyzing the other said signals to decide on the electrical shock therapy to be provided to the heart, wherein said first signal comprises an electrically derived ECG heart rate, wherein said device is a cardioverting/defibrillating pacemaker implanted in the patient at a location remote from the patient's cardiac cavity, wherein said device is provided with sensing leads which interconnect the chambers of the patient's heart with respect to first and second electrical sensing circuits in the first and second sensing means of said device, wherein said electrical sensing circuits include corresponding sensing amplifiers, and wherein said method further includes the steps of:
• periodically assessing the impedance of the ECG sensing leads to insure that it is within predetermined limits;
• periodically assessing the amplitude of the amplified ECG signal outputted by the ECG sensing amplifier and adjusting the gain of said sensing amplifier to ensure that said output of said amplifier is maintained within predetermined limits;
• and, establishing that the patient's heart is in a state of normal function both before and during the adjustment of the gain of the ECG sensing amplifier by relying on haemodynamic heart function information obtained from said second signal.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered-peak-to-peak pressure amplitude, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether a malfunction exists in the sensing means which provides said one of said signals and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of a malfunction in the sensing means which provides said one of said signals, analyzing the other said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is a cardioverting/defibrillating pacemaker implanted in the patient at a location remote from the patient's cardiac heart cavity, wherein said device is provided with ventricular pressure, "VP", sensing leads which interconnect chambers of the patient's heart with respect to first and second electrical sensing circuits in the first and second sensing means of said device, wherein said electrical sensing circuits include corresponding sensing amplifiers, and wherein said method further includes the steps of:
• periodically assessing the impedance of the VP sensing leads to ensure that it is within predetermined limits;
• periodically assessing the amplitude of the amplified VP signal outputted by the VP sensing amplifier and adjusting the gain of said sensing amplifier to ensure that said output of said amplifier is maintained within predetermined limits;
• and establishing that the patient's heart is in a state of normal function both before and during the adjustment of the gain of the VP sensing amplifier by relying upon ECG heart function information obtained from said first signal.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a right ventricular filtered-peak-to-peak pressure amplitude, "RVFPPA", or a right ventricular peak pressure function, "RVPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether a malfunction exists in the sensing means which provides said one of said signals and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of a malfunction in the sensing means which provides said one of said signals, analyzing the other said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is a cardioverting/defibrillating pacemaker, wherein said second signal is representative of the right ventricular pressure waveform of the heart, wherein the state of the heart's function is derived form said second signal when there is an uncertainty in the diagnosis of said state as derived from said first signal, and wherein said method further includes the steps of:
• analyzing the state of the heart's function during periods of such uncertainty based on a comparison of the level of either RVFPPA or RVPPF with a first predetermined threshold index thereof and (i) providing no therapy if said first threshold index is crossed repeatedly by said level within a programmed interval, (ii) providing ATP therapy if said level does not cross said first threshold index repeatedly during said programmed interval but crosses a second predetermined threshold index repeatedly during said programmed interval, (iii) providing bradycardia support pacing therapy if said level does not cross said second predetermined threshold index repeatedly during said programmed interval, and (iv) providing defibrillation therapy if an evoked pressure response is not sensed in response to said bradycardia support pacing.

A method of treating malfunctions of a patient's heart, comprising the steps of:

• implanting in a patient a device having a first means for sensing an electrical function in the patient's heart and providing a first signal representative of said electrical function, a second means for sensing an haemodynamic function in the patient's heart and providing a second signal representative of said haemodynamic function, said second signal comprising either a ventricular filtered-peak-to-peak pressure, "VFPPA", or a ventricular peak pressure function, "VPPF";
• analyzing one of said signals to determine the state of the heart's function, determine whether a malfunction exists in the sensing means which provides said one of said signals and decide on any required electrical shock therapy to be provided to the heart;
• and, in the event of a malfunction in the sensing means which provides said one of said signals, analyzing the other said signals to decide on the electrical shock therapy to be provided to the heart, wherein said device is implanted in the patient at a location remote from the patient's cardiac cavity, wherein said device is provided with sensing leads which interconnect chambers of the patient's heart with electrical sensing circuits in the first and second sensing means of said device, and wherein said method further includes the steps of checking that the impedance of said ECG sensing leads is within predetermined limits and, if it is not, then determining whether or not pacing is still possible by applying a short train of pacing pulses at a pre-programmed rate and checking for ventricular pressure responses thereto;
• if pacing is determined to still be possible, altering control of the device so that it relies solely upon pressure derived information to determine the state of the heart's function;
• and, providing a warning signal to alert the patient or his attending physician of a system failure.