HUB-BASED STRATEGY FOR REDUCING HARDWARE AND ALGORITHMIC SUPPORT NEEDS IN A LEAD-LESS PACING SYSTEM THAT LEVERAGES TRIGGERED MESSAGING THROUGH A BODY AREA NETWORK

Abstract

An implantable device system for applying electrical stimulation to a patient, including: a first implantable device configured to measure at least one parameter indicative of a physiological or an activity state of the patient, a second implantable device configured to apply and/or adapt electrical stimulation to the patient in response to said at least one parameter, and wherein the first implantable device is further configured to communicate information pertaining to said at least one parameter to the second implantable device.

Claims

1. An implantable device system for applying electrical stimulation to a patient, comprising: a first implantable device configured to measure at least one parameter indicative of a physiological or an activity state of the patient, a second implantable device configured to apply and/or adapt electrical stimulation to the patient in response to said at least one parameter, and wherein the first implantable device is further configured to communicate information pertaining to said at least one parameter to the second implantable device.

2. The implantable device system according to claim 1, wherein the second implantable device is a pacemaker configured to apply electrical stimulation to a heart of the patient.

3. The implantable device system according to claim 2, wherein the second implantable device is an implantable lead-less pacemaker that is configured to be implanted into a chamber (RA, RV, LV) or on a chamber (RA, RV) of said heart of the patient.

4. The implantable device system according to claim 2, wherein the second implantable device is configured to apply electrical stimulation in the form of electrical pulses having a pulse rate to the patient, particularly to the heart of the patient, wherein the device system is configured to adapt said electrical stimulation by adapting said pulse rate, wherein the first implantable device is configured to measure said at least one parameter indicative of an activity state of the patient, wherein the first implantable device is further configured to communicate a signal (C) to the second implantable device in case said activity state exceeds one or more thresholds, wherein in turn the second implantable device is configured to adapt the pulse rate in response to said signal.

5. The implantable device system according to claim 1, wherein the first implantable device is configured to sense cardiac responses of the patient to the electrical stimulation of the second implantable device, wherein the cardiac response is in particular cardiac capture, wherein the first implantable device is configured to periodically assess the correspondence of said sensed cardiac responses of the patient to said electrical stimulation for grading its efficacy.

6. The implantable device system according to claim 1, wherein the first implantable device is configured to trigger a signal (C) when the at least one measured parameter meets one or more pre-defined criterion, wherein the signal upon reception by the second implantable device transitions the first and the second implantable device into a dialogue mode, where the second implantable device streams data sensed by the second implantable device to the first implantable device for storage.

7. The implantable device system according to claim 2, wherein the first implantable device is configured to detect electrocardiogram signals from the heart of the patient and is further configured to store said signals in a memory.

8. The implantable device system according to claim 2, wherein the first implantable device forms a subcutaneous implantable cardioverter-defibrillator (s-ICD) that is configured to apply electrical stimulation to the heart of the patient for providing defibrillation of the heart.

9. The implantable device system according to claim 1, wherein the first and the second implantable device are configured to communicate via a wireless body area network (WBAN).

10. The implantable device system according to claim 1, wherein the first implantable device is configured to perform data transfer with an external unit.

11. The implantable device system according to claim 10, wherein the external unit is a programmer device, a patient device, or hardware that interfaces with an external service center.

12. The implantable device system according to claim 1, wherein the first implantable device comprises at least one pair of electrodes for sensing electrical potentials.

13. A method for operating a device system according to claim 1, comprising the steps: measuring at least one parameter indicative of a physiological or an activity state of the patient via a first implantable device, communicating information pertaining to said at least one parameter from the first implantable device to a second implantable device, applying and/or adapting electrical stimulation to the patient in response to said at least one parameter via the second implantable device.

14. The method for operating a device system according to claim 13, further comprising the steps: communicating information indicative of a physiological or an activity state of the patient to an external unit by the first implantable device, wherein the information indicative of a physiological or an activity state of the patient is measured via the first implantable device or the second implantable device.

Description

DESCRIPTION OF THE DRAWINGS

[0047] Other advantages and expedient features of the present invention follow from the following description of sample embodiments, which make reference to the Figure. The Figure is as follows:

[0048] FIG. 1 shows an embodiment of an implantable device system according to the present invention.

DETAILED DESCRIPTION

[0049] FIG. 1 shows an implantable device system 1 for applying electrical stimulation to a patient, particularly to the heart 2 of the patient, according to the present invention. The system 1 comprising: a first implantable device 10 configured to measure at least one parameter indicative of a physiological or activity state of the body of the patient, particularly of the heart 2 of the patient, and a second implantable device 20 configured to apply and/or adapt electrical stimulation to the patient/heart 2 for therapy purposes in response to said at least one parameter, wherein the first implantable device 10 is further configured to communicate said at least one parameter to the second implantable device 20.

[0050] Further, particularly, the second implantable device 20 is an implantable lead-less pacemaker (LP) 20 which is configured to apply electrical stimulation to the heart 2 of the patient in the form of electrical pacing pulses, particularly in order to provide anti-bradycardia pacing and/or anti-tachycardia pacing (ATP). Particularly, the LP 20 may comprise a hermetically sealed housing 20d enclosing a pulse generator 20b for generating said pacing pulses and a battery 20a for supplying energy to the pulse generator 20b. The lead-less pacemaker 20 may further comprise fastening means provided on the housing 20d for fastening the LP 20 to the chamber/ventricle (here the right ventricle RV), and a pacing electrode 20c provided, e.g., on an end of the housing 20d of the LP 20 for applying said electrical pacing pulses to the heart 2. Regarding the LP 20, the notion lead-less means that the primary electrode 20c of the LP 20 is not connected via an external lead to the housing 20d of the LP 20 but is provided on the housing 20d. Secondary electrodes (not shown in figure) may exist on lead like extensions from the housing 20d in some embodiments.

[0051] Furthermore, particularly, the first implantable device 10 is a cardiac monitoring device 10, particularly an implantable loop recorder 10 that is configured to receive electrocardiogram signals via a pair of electrodes 11a and 11b and to store the corresponding electrocardiogram (ECG) in a (e.g., circular) buffer of the recorder 10. Alternatively, the first implantable device 10 can be a subcutaneous implantable cardioverter-defibrillator that is configured to apply electrical stimulation to the heart (2) for providing defibrillation of the heart (2).

[0052] In either embodiment, the respective first implantable device 10 forms a subcutaneous cardiac monitoring hub 10 that particularly occupies a larger volume than that of the LP 20. This larger volume is particularly used to accommodate a higher capacity battery, added componentry, and greater processing capabilities as described herein. Further, because the hub 10 is implanted subcutaneously, it is easy to explant and replace when the battery runs low, whereas the LP 20 is much more difficult to explant. Further, because the hub 10 is preferably configured to reside near the patient's skin surface, it can gather system-affiliated data and send it to a remote monitoring infrastructure 30 without any need for direct patient interaction.

[0053] To minimize the overhead affiliated with this revised approach to baseline feature support, the coordination of message relay within the patient's body may also be aligned with prevailing cardiac activity to enable low-power receiver implementations within the LP 20. The triggered calls for action from the hub 10 could also be enabled as loud (e.g., High Energy Pulse (HEP)-like) signals that wake up the LP 20 without forcing the in-heart implant, i.e. the LP, to consume unfavorable amounts of energy waiting for such cues.

[0054] Particularly, the LP 20 is configured to apply electrical stimulation in the form of electrical pulses having a pulse rate to heart 2, wherein the system 1 is configured to adapt said electrical stimulation by adapting said pulse rate, wherein the hub 10 is configured to measure said at least one parameter indicative of an activity state of the patient, wherein the first implantable device is further configured to communicate a signal via a wireless communication link C to the LP 20 in case activity state measured by the hub 10 exceeds a pre-defined threshold, wherein in turn the LP is configured to adapt the pulse rate in response to said signal from the hub 10.

[0055] Communication link C is an ultra-low power communication link suitable for intrabody communication. In one embodiment, it is galvanic communication in which electrodes from one device put modulated current or voltage pulses into the body. These current or voltage pulses generate small E-fields in the body which are detected by electrodes of the second device. In an alternative embodiment, acoustic signals as, e.g., modulated ultrasonic signals are used for communication. Ultrasonic frequencies (>30 kHz) are used so that the patient is not bothered by hearing the signals. In both methods data is encoded in the modulation of the signals.

[0056] Furthermore, particularly, the hub 10 is configured to trigger a signal when the at least one measured parameter or another parameter measured by the hub 10 meets a pre-defined criterion that indicates the need for holter storage, wherein the signal upon reception by the LP transitions the hub 10 and the LP 20 into a dialogue mode, where the LP 20 streams data sensed by the LP (e.g., an ECG) to the hub 10 via a wireless communication link C for remote storage. The communication link C may support bi-directional communication. Particularly, storage of the ECG data may take place in the hub 10 or in a further external device 30,wherein the hub 10 may communicate with said external device 30 via a wireless communication link C (which may also support bi-directional communication). In some embodiments, the LP (20) can also initiate a holter storage where the LP streams data to the hub.

[0057] Such a setup would mean that information sensed within the heart 2 could be retained in the less volumetrically constrained hub 10. Further, coordinated snapshots would prove accessible wherein the hub 10 is configured to capture a sensed patient response of its own while also collecting the sensed data from the in-heart LP 20. By collecting two electrical signatures of patient behaviors assessed from different vantages within a shared survey window, it may prove possible to improve upon meaningful clinical diagnostic capabilities.

[0058] In another embodiment, the LP 20 contains enough memory to locally store a few ECG episodes. In this embodiment, the LP 20 can locally store a ECG episode and then later transmit it to the hub 10 for longer term storage. This embodiment eliminates the need for the ECG to be transmitted to the hub in real time, while still providing the benefit of not burdening the LP 20 with large amounts of memory for episode storage.

[0059] Particularly, according to a further embodiment, the hub 10 may be configured to conduct all remote monitoring interactions and particularly constitutes the only device of the system 1 according to the present invention that is capable of supporting direct interactions with an external unit 30. The external unit 30 may be a programming device for programming the LP 20 and/or the hub device 10, and for interrogating the LP, and further for performing follow-up tests on the LP, particularly via a wireless communication link C. The external unit may also be a patient device where the data received from the hub device may be further processed, evaluated, displayed to users or the patient, and sent to other devices or a service center, or the like, for the purpose of remote monitoring of the physiological state of the patient. The external unit may also be an external service center where the data may be further processed, evaluated or the like, for the purpose of remote monitoring of the physiological state of the patient.

[0060] Particularly, according to an embodiment, the hub 10 and the LP 20 are configured to communicate all data that is to be transferred between the hub 10 and the LP 20 via a wireless body area network (WBAN).

[0061] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein.

[0062] Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.