Patent Application
20080103406
This document generally relates to cardiac rhythm management (CRM) systems and particularly to a system for externally sensing heart sounds and automatically programming an implantable medical device as a function of the sensed heart sounds.
The heart is at the center of the circulatory system. It consists of four chambers—two atria and two ventricles. The right atrium receives deoxygenated blood from the body, pumps it into the right ventricle, and the right ventricle pumps the blood to the lungs to be re-oxygenated. The re-oxygenated blood returns to the left atrium, it is pumped into the left ventricle, and then the blood is pumped by the left ventricle throughout the body to meet the hemodynamic needs of the body.
Heart sounds are associated with mechanical vibrations from activity of a patient's heart and the flow of blood through the heart. Heart sounds recur with each cardiac cycle and are separated and classified according to the activity associated with the vibration. The first heart sound (S1) is the vibrational sound made by the heart during tensing of the mitral valve. The second heart sound (S2) marks the beginning of diastole. The third heart sound (S3) and fourth heart sound (S4) are related to filling pressures of the left ventricle during diastole. Heart sounds are useful indications of proper or improper functioning of a patient's heart.
Implantable medical devices (IMDs) are devices designed to be implanted into a patient. Some examples of these devices include cardiac function management (CFM) devices such as implantable pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices, and devices that include a combination of such capabilities. The devices are typically used to treat patients using electrical therapy and to aid a physician or caregiver in patient diagnosis through internal monitoring of a patient's condition. The devices may include electrodes in communication with sense amplifiers to monitor electrical heart activity within a patient, and often include sensors to monitor other internal patient parameters. Other examples of implantable medical devices include implantable diagnostic devices, implantable insulin pumps, devices implanted to administer drugs to a patient, or implantable devices with neural stimulation capability.
In an embodiment, an external heart sound sensor is adapted to externally detect at least one heart sound from a patient. An external telemetry circuit is coupled to the external heart sound sensor, and the telemetry circuit receives information about the at least one heart sound. The external telemetry circuit is also adapted to communicate with an implantable medical device for automatically programming at least one parameter of the implantable medical device using information about the at least one heart sound received from the external heart sound sensor.
In Example 1, a system includes an external heart sound sensor adapted to externally detect at least one heart sound from a patient. The system also includes an external telemetry circuit that is coupled to the external heart sound sensor to receive information about the at least one heart sound. The external telemetry circuit is further adapted to communicate with an implantable medical device for automatically programming at least one parameter of the implantable medical device using information about the at least one heart sound received from the external heart sound sensor.
In Example 2, the system of Example 1 optionally includes an external processor that is coupled to each of the external heart sound sensor and the external telemetry circuit. The external processor is optionally configured to automatically determine a value of the at least one parameter of the implantable medical device using the information about the at least one heart sound received from the external heart sound sensor. The system of Example 1 further optionally includes a user interface to obtain user-confirmation of the value of the at least one parameter in conjunction with the automatic programming of the at least one parameter.
In Example 3, in the systems of Examples 1-2, the external processor and the external telemetry circuit are optionally included within an external programmer for an implantable cardiac function management device, the external heart sound sensor is optionally associated with an external heart sound system that is housed separately from the external programmer, and the external heart sound system and the external programmer are optionally adapted to be communicatively intercoupled.
In Example 4, in the systems of Examples 1-3, at least a portion of the external processor, the external telemetry circuit, and the external heart sound sensor are all optionally included within an external programmer for an implantable cardiac function management device.
In Example 5, the systems of Examples 1-4 optionally include an implantable or external cardiac signal sensor and an external display. The external display is optionally coupled to the external heart sound sensor and the implantable or external cardiac signal sensor, and the external display is optionally configured to display a heart sound signal and a cardiac signal. Additionally, the external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an observed heart sound amplitude received from the external heart sound sensor, and the observed heart sound amplitude optionally includes an observed S3 heart sound amplitude received from the external heart sound sensor.
In Example 6, the systems of Examples 1-5 optionally include the implantable medical device, and the external telemetry circuit is optionally adapted to communicate with an implantable medical device for automatically adjusting at least one of an atrioventricular (AV) delay, an interventricular (VV) delay, an LV offset, an intraventricular delay, and a selected electrode for delivering an electrostimulation pulse, and the implantable medical device optionally includes a cardiac resynchronization therapy circuit.
In Example 7, the systems of Examples 1-6 optionally include a remote device and an external network communication circuit adapted to communicate with the remote device using a computer or telecommunications network. The remote device optionally includes a centralized repository for data received from multiple implantable medical devices.
In example 8, the systems of Examples 1-7 optionally include one or more of a serial port, parallel port, and a wireless port, coupled between the external heart sound sensor and the external telemetry circuit. The serial port optionally includes an RS-232 port, a Universal Serial Bus (USB) port, or a fly-by-wire port.
In Example 9, a method includes externally detecting at least one heart sound signal from a patient, and communicating with an implantable medical device, the communicating including automatically programming at least one parameter of the implantable medical device using information about the at least one heart sound.
In Example 10, the method of Example 9 optionally includes automatically determining a value of the at least one parameter of the implantable medical device using the information about the at least one heart sound received from the external heart sound sensor, obtaining user-confirmation of the value of the at least one parameter in conjunction with the automatic programming of the at least one parameter, and detecting a cardiac signal from the patient, and displaying the heart sound signal and the cardiac signal on an external display unit.
In Example 11, the methods of Examples 9-10 optionally include automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an externally detected heart sound amplitude. The externally detected heart sound amplitude optionally includes an externally detected S3 heart sound amplitude.
In Example 12, the methods of Examples 9-11 optionally include automatically communicating with the implantable medical device to automatically adjust at least one of an atrioventricular (AV) delay, an interventricular (VV) delay, an LV offset, an intraventricular delay, and a selected electrode for delivering an electrostimulation pulse.
In Example 13, the methods of Examples 9-12 optionally include communicating data from multiple implantable medical devices to a remote device using a computer or telecommunications network.
In Example 14 a system includes an external heart sound monitor that includes a terminal configured to receive at least one heart sound signal from an external heart sound sensor, and a port configured to communicate with an implantable medical device for automatically programming at least one parameter of the implantable medical device using information about the at least one heart sound received from the external heart sound sensor.
In Example 15, the system of Example 14 optionally includes a display unit to display the at least one heart sound signal received from the external heart sound sensor, and an external or implantable cardiac signal sensor coupled to the display, the external display is optionally configured to display a heart sound signal and a cardiac signal.
In Example 16, the systems of Examples 14-15 optionally include an external telemetry circuit that is coupled to the port. The external telemetry circuit is optionally adapted to communicate with the implantable medical device for the automatic programming of the at least one parameter of the implantable medical device using information about the at least one heart sound received from the external heart sound sensor. The systems of Examples 14-15 further optionally include an external processor that is coupled to each of the terminal and the port. The external processor is optionally configured to automatically determine a value of the at least one parameter of the implantable medical device using the information about the at least one heart sound received from the external heart sound sensor. The external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting at least one of an atrioventricular (AV) delay, an interventircular (VV) delay, an LV offset, an intraventricular delay, and a selected electrode for delivering an electrostimulation pulse. The external processor and the external telemetry circuit are optionally included within an external programmer for an implantable cardiac function management device. The external heart sound monitor is optionally associated with an external heart sound system that is housed separately from the external programmer. The heart sound system and the external programmer are optionally adapted to be communicatively intercoupled. Additionally, at least a portion of the external processor, the external telemetry circuit, and the external heart sound sensor are all optionally included within an external programmer for an implantable cardiac function management device.
In Example 17, in the systems of Examples 14-16, the external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an observed heart sound amplitude received from the external heart sound sensor. The external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an observed S3 heart sound amplitude from the external heart sound sensor.
In Example 18, the systems of Examples 14-17 optionally include the implantable medical device, and the implantable medical device optionally includes a cardiac resynchronization therapy circuit.
In Example 19, the systems of Examples 14-18 optionally include a remote device and an external network communication circuit optionally adapted to communicate with the remote device using a computer or telecommunications network. The remote device optionally includes a central repository for data received from multiple implantable medical devices.
In Example 20, the systems of Examples 14-19 optionally include a user interface to obtain user-confirmation of the value of the at least one parameter in conjunction with the automatic programming of the at least one parameter. The port optionally includes a serial RS-232 port, a Universal Serial Bus (USB) port, or a fly-by-wire port.
In Example 21, a system includes an external programmer including a port configured to receive at least one heart sound from an external heart sound sensor and an external telemetry circuit. The external telemetry circuit is coupled to the external programmer, and the external telemetry circuit adapted to communicate with an implantable medical device for automatically programming at least one parameter of the implantable medical device using information about the at least one heart sound received from the external programmer.
In Example 22, the systems of Examples 20-21 optionally include an external processor, coupled to each of the external programmer and the external telemetry circuit. The external processor is optionally configured to automatically determine a value of the at least one parameter of the implantable medical device using the information about the at least one heart sound received from the external programmer. In Example 22, the systems of Examples 20-21 further optionally include a user interface to obtain user-confirmation of the value of the at least one parameter in conjunction with the automatic programming of the at least one parameter. The external processor and the external telemetry circuit are optionally included within the external programmer, and the external heart sound sensor is optionally associated with an external heart sound system that is housed separately from the external programmer. The external heart sound system and the external programmer are optionally adapted to be communicatively intercoupled. At least a portion of the external processor, the external telemetry circuit, and the external heart sound sensor are all optionally included within the external programmer.
In Example 23, the systems of Examples 20-22 optionally include an implantable or external cardiac signal sensor and an external display. The external display is optionally coupled to the external heart sound sensor and the implantable or external cardiac signal sensor, and the external display is optionally configured to display a heart sound signal and a cardiac signal. The external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an observed heart sound amplitude received from the external programmer. The external telemetry circuit is optionally adapted to communicate with the implantable medical device for automatically adjusting a cardiac resynchronization therapy parameter to decrease or minimize an observed S3 heart sound amplitude received from the external programmer.
In Example 24, the systems of Examples 20-22 optionally include a remote device, an external network communication circuit that is optionally adapted to communicate with the remote device using a computer or telecommunications network, and the implantable medical device. The external telemetry circuit is optionally adapted to communicate with an implantable medical device for automatically adjusting at least one of an atrioventricular (AV) delay, an interventricular (VV) delay, an LV offset, an intraventricular delay, and a selected electrode for delivering an electrostimulation pulse. The implantable medical device optionally includes a cardiac resynchronization therapy circuit. The remote device optionally includes a centralized repository for data received from multiple implantable medical devices.
In Example 25, the systems of Examples 20-24 optionally include a serial port coupled between the external heart sound sensor and the external telemetry circuit. The serial port optionally includes an RS-232 port, a Universal Serial Bus (USB) port, or a fly-by-wire port.
This overview relates to some of the teachings of the present application and it is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the invention will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof. The scope of the present invention is defined by the appended claims and their legal equivalents.
The drawings illustrate generally, by way of example, various embodiments discussed in the present document. The drawings are for illustrative purposes only and may not be to scale.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims and their legal equivalents.
In certain examples, the implantable medical device 101 can include an implantable cardiac rhythm management device that can deliver one or more of pacing, cardiac resynchronization or anti-tachyarrhythmia therapies such as anti-tachyarhythmia pacing (ATP), cardioversion and defibrillation therapies. The implantable medical device 101 can include one or more of other monitoring and/or therapeutic devices such as a cardiac pacer, a cardioverter/defibrillator, a neural stimulator, a drug delivery device, and a biological therapy device. Implantable medical device 101 generally includes a hermetically sealed can housing an electronic circuit that typically senses physiological signals and/or delivers therapeutic electrical pulses. The hermetically sealed can may also function as an electrode, such as for sensing and/or pulse delivery purposes. In certain examples, as illustrated in
In this example, the external system 120 includes an external heart sound sensor 122, an external telemetry circuit 124, and a communication link 123. In at least one example, the external system 120 can be a local or remote external programmer for the implantable medical device 101. The telemetry circuit 124 generally communicates with implantable medical device 101, such as via telemetry link 103, and generally allows altering the functionality of the implantable device 101, for example, as a function of one or more sensed heart sounds. The telemetry link 123 may be a wired link or more typically a wireless link, and allows for communication between the telemetry circuit 124 and heart sound sensor 122.
The telemetry link 103 can be a wireless communication link providing for bidirectional data transmission between implantable medical device 101 and the external system 120. In certain examples, telemetry link 103 is an inductive telemetry link. In an alternative example, telemetry link 103 is a far-field radio-frequency telemetry link. Other types of a telemetry link 103 (e.g., ultrasound, infrared, etc.) could similarly be used. The external telemetry circuit 124 is adapted to communicate, through the telemetry link 103, with the implantable medical device 101. In this way, the external system 120 can automatically program at least one parameter of the implantable medical device 101, such as by using information about the at least one heart sound received from the external heart sound sensor 122. In an example in which the telemetry link 103 provides for data transmission from implantable medical device 101 to the external system 120, the transmission can include transmitting real-time physiological data acquired by implantable medical device 101, extracting physiological data acquired by and stored in implantable medical device 101, extracting therapy history data stored in implantable medical device 101, and/or extracting data indicating an operational status of implantable medical device 101 (e.g., battery status and/or lead impedance). In an example in which the telemetry link 103 provides for data transmission from the external system 120 to the implantable medical device 101, this transmission can include, for example, programming implantable medical device 101 to acquire physiological data, programming implantable medical device 101 to perform at least one self-diagnostic test (such as for a device operational status), programming implantable medical device 101 to enable an available monitoring or therapeutic function, and/or programming implantable medical device 101 to adjust one or more therapeutic parameters such as pacing, cardioversion, and/or defibrillation parameters.
In the example of
External heart sound monitor 220 is another example of external system 120. In this example, the external heart sound monitor 220 includes programmer/terminal 226, a heart sound sensor 222, a port 229, a communication link 221, and a communication link 225. In an example, the port 229 automatically programs at least one parameter of the IMD 101 using a wireless communication circuit and information from at least one heart sound of the external heart sound sensor 222. The port 229 can include a serial RS-232 port, a Universal Serial Bus (USB) port, or a fly-by-wire connection.
The external heart sound monitor 220A may further include a processor 223 coupled to the terminal/programmer 226 and the port 229. The processor 223 can be configured to automatically determine a suggested value of a therapy control parameter of the IMD 101, such as by using information about a heart sound received from the external heart sound sensor 222. In another example, illustrated in
External programmer 320 is another example of external system 120 and includes a port 329. In this example, an external heart sound sensor 322 is coupled to the external programmer 320 through the port 329. In this example, an external telemetry circuit 324 is also coupled to or included in the external programmer 320. The telemetry circuit 324 can be configured to communicate with the IMD 101 and to automatically program at least one parameter of the IMD 101, such as using heart sound information received form the external heart sound sensor 322. The port 329 can include a serial RS-232 port, a Universal Serial Bus (USB) port, or a fly-by-wire connection.
The external processor 323 and the external telemetry circuit 324 can be included within an external programmer 320B as shown in the CRM system 300B of
The external telemetry circuit 324 can be configured to perform one or more of several functions. For example, the telemetry circuit 324 may be configured to communicate with the IMD 101 to automatically adjust a cardiac resynchronization therapy parameter in a cardiac resynchronization therapy circuit 102. This adjustment can be made in response to feedback received from the external heart sound sensor 322, such as to decrease or minimize an observed heart sound amplitude, energy, or other indicator received from the external heart sound sensor 322 via the external programmer 320, 320A, 320B or 320C. In certain examples, the adjustment of the cardiac resynchronization parameter is meant to decrease or minimize an observed S3 heart sound amplitude received from the external heart sound sensor 322 via the external programmer 320. The telemetry circuit 324 can be configured to communicate with the IMD 101, for example, to automatically adjust an atrioventricular (AV) delay, an interventricular (VV) delay, an LV offset, an intraventricular delay, and a selected electrode for delivering an electrostimulation pulse.
One or more examples of the present disclosure may be used in conjunction with other medical equipment in the market such as the AUDICOR® systems of Inovise Medical, Inc. of Portland, Oreg.
It is to be understood that the above detailed description is intended to be illustrative, and not restrictive. Other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
In the above detailed description of embodiments of the disclosure, various features are grouped together in one or more embodiments for streamlining the disclosure. This is not to be interpreted as reflecting an intention that the claimed embodiments of the invention require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the detailed description of embodiments, with each claim standing on its own as a separate embodiment. It is understood that the above description is intended to be illustrative, and not restrictive. It is intended to cover all alternatives, modifications and equivalents as may be included within the scope of the disclosure as defined in the appended claims. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein,” respectively. Moreover, the terms “first,” “second,” and “third,” etc., are used merely as labels, and are not intended to impose numerical requirements on their objects.
As used in this disclosure, the term “circuit” is broadly meant to refer to hardware, software, and a combination of hardware and software. That is, a particular function may be implemented in specialized circuits, in software executing on general processor circuits, and/or a combination of specialized circuits, generalized circuits, and software.
The abstract is provided to comply with 37 C.F.R. 1.72(b) to allow a reader to quickly ascertain the nature and gist of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.
