Source: http://www.patentsencyclopedia.com/app/20160089538
Timestamp: 2020-07-04 16:09:10
Document Index: 478340115

Matched Legal Cases: ['art.\n5', 'art.\n15', '§120', '§120', '§120', '§120', '§120']

Patent application number: 20160089538
2. A system, comprising: an implantable neurostimulator configured to deliver neural stimulation to a vagus nerve in a cervical region to non-selectively stimulate both afferent and efferent axons in the vagus nerve, wherein the implantable neurostimulator includes: a memory configured to store programmable parameters to control a programmed intensity and programmed schedule of the delivered neural stimulation, wherein the programmable parameters control intermittent and periodic electrical pulses according to the programmed schedule; the pulse generator configured to therapeutically deliver the scheduled neural stimulation to the vagus nerve independent of cardiac cycle through electrodes via an electrically coupled nerve lead; a heart rate sensor configured to sense heart rate; and a controller configured to respond to the sensed heart rate by titrating delivery of the scheduled neural stimulation.
3. The system of claim 2, wherein the controller is configured to use the heart rate sensor to sense a bradycardia condition.
4. The system of claim 2, wherein the heart rate sensor includes electrodes that are positioned external to a heart.
5. The system of claim 2, further comprising a leadless heart rate sensor configured as part of the pulse generator to sense a patient's heart rate.
6. The system of claim 2, wherein the implantable neurostimulator includes a housing, and the leadless heart rate sensor includes leadless ECG electrodes on the housing.
7. The system of claim 2, wherein the programmed schedule includes a programmed therapy duration selected to avoid physiological habituation to the neural stimulation.
8. The system of claim 2, wherein the programmed schedule includes programmed intermittent neural stimulation associated with on/off timing selected to avoid physiological habituation to the neural stimulation.
9. The system of claim 2, wherein the programmed schedule includes a programmed therapy duration parameter to control a therapy duration per therapy period.
10. The system of claim 2, wherein the programmed schedule includes a programmed therapy period to control a duration of time before a subsequent therapy is provided.
11. The system of claim 2, wherein the programmed schedule includes a programmed duty cycle to control intermittent timing during a therapy period.
12. A method, comprising: using an implantable neurostimulator that includes a pulse generator and a memory to deliver neural stimulation to a vagus nerve in a cervical region to non-selectively stimulate both afferent and efferent axons in the vagus nerve, including: storing programmable parameters to control a programmed intensity and programmed schedule of the delivered neural stimulation, wherein the programmable parameters control intermittent and periodic electrical pulses according to the programmed schedule; therapeutically delivering the maintenance doses to the vagus nerve independent of cardiac cycle via a the pulse generator through electrodes via an electrically coupled lead; monitoring heart rate using a heart rate sensor, wherein the implantable neurostimulator includes the heart rate sensor, and responding to sensed heart rate by titrating delivery of the scheduled neural stimulation to the vagus nerve.
13. The method of claim 12, further comprising sensing a bradycardia condition using the heart rate sensor.
14. The method of claim 13, wherein the heart rate sensor is positioned external to a heart.
15. The method of claim 12, wherein the heart rate sensor includes a leadless heart rate sensor.
16. The method of claim 15, wherein the implantable neurostimulator includes a housing, and the leadless heart rate sensor includes leadless ECG electrodes on the housing.
17. The method of claim 12, wherein the programmed schedule includes a programmed therapy duration selected to avoid physiological habituation to the neural stimulation.
18. The method of claim 12, wherein the programmed schedule includes programmed intermittent neural stimulation associated with on/off timing selected to avoid physiological habituation to the neural stimulation.
19. The method of claim 12, wherein the programmed schedule includes a programmed therapy duration parameter to control a therapy duration per therapy period.
20. The method of claim 12, wherein the programmed schedule includes a programmed therapy period to control a duration of time before a subsequent therapy is provided, and a programmed duty cycle to control intermittent timing during a therapy period.
21. A non-transitory computer readable storage medium storing code for executing on a computer system to perform the method according to claim 12.
[0001] This application is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 14/246,279, filed on Apr. 7, 2014, which is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 13/793,702, filed on Mar. 11, 2013, now issued as U.S. Pat. No. 8,694,104, which is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 13/585,466, filed on Aug. 14, 2012, now issued as U.S. Pat. No. 8,401,653, which is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 13/217,794, filed on Aug. 25, 2011, now issued as U.S. Pat. No. 8,249,711, which is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 12/231,372, filed on Sep. 2, 2008, now issued as U.S. Pat. No. 8,010,198, which claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No. 60/972,154, filed on Sep. 13, 2007, which are all incorporated herein by reference in their entirety.
[0030] It is believed that prolonged neural stimulation, such as a duty cycle over 50%, may result in physiological adaptation to the stimulation. Some embodiments of the present subject matter limit the duty cycle of continuous neural stimulation delivered during a scheduled neural stimulation session. For example, an embodiment limits the duty cycle to below 50%. Some embodiments limit the stimulation period for the intermittent stimulation cycle. For example, some embodiments limit the stimulation period to a time under five minutes, such that a new neural stimulation train will begin within five minutes of the previous neural stimulation train. Some embodiments, for example, deliver neural stimulation on the order of ten seconds per minute (duty cycle≈17%; neural stimulation period 1 minute; duration of neural stimulation train≈ten seconds).
[0032] The automatic nervous system (ANS) regulates "involuntary" organs, while the contraction of voluntary (skeletal) muscles is controlled by somatic motor nerves. Examples of involuntary organs include respiratory and digestive organs, and also include blood vessels and the heart. Often, the ANS functions in an involuntary, reflexive manner to regulate glands, to regulate muscles in the skin, eye, stomach, intestines and bladder, and to regulate cardiac muscle and the muscle around blood vessels, for example.
[0033] The ANS includes the sympathetic nervous system and the parasympathetic nervous system. The sympathetic nervous system is affiliated with stress and the "fight or flight response" to emergencies. Among other effects, the "fight or flight response" increases blood pressure and heart rate to increase skeletal muscle blood flow, and decreases digestion to provide the energy for "fighting or fleeing." The parasympathetic nervous system is affiliated with relaxation and the "rest and digest response" which, among other effects, decreases blood pressure and heart rate, and increases digestion to conserve energy. The ANS maintains normal internal function and works with the somatic nervous system.
[0059] A neural stimulation waveform may be delivered with phases of alternating polarity, referred to herein as first and second phases. For example, the waveform may be delivered as monophasic pulses with a bipolar stimulating configuration and with a "bipolar switch" so that the phase of the monophasic pulses is alternated in each consecutive pulse train. That is, a pulse train with monophasic pulses having first phases of one polarity is then followed by a pulse train with monophasic pulses having second phases of the opposite polarity. FIGS. 6 and 7 show example waveforms as would be produced by recording the potential between the stimulation electrodes. FIG. 6 shows an example of such a waveform in which a monophasic pulse train MPT1 having first phases FP1 of positive polarity is followed by a monophasic pulse train MPT2 having second phases SP1 of negative polarity. In another embodiment, the stimulation circuitry may be configured to deliver a pulse train with biphasic pulses so that the first phase alternates with the second phase (i.e., each consecutive pulse in the train alternates in polarity). FIG. 7 shows an example of a biphasic pulse train BPT1 having first phases FP2 and second phases SP2 that alternate in polarity. Such biphasic pulse trains with alternating polarities or a series of monophasic pulses trains having alternating polarities may be applied continuously or on a periodic or intermittent basis for a specified period of time.
[0065] FIG. 12 illustrates a system 1237 including an implantable medical device (IMD) 1238 and an external system or device 1239, according to various embodiments of the present subject matter. Various embodiments of the IMD include NS functions or include a combination of NS and CRM functions. The IMD may also deliver biological agents and pharmaceutical agents. The external system and the IMD are capable of wirelessly communicating data and instructions. In various embodiments, for example, the external system and IMD use telemetry coils to wirelessly communicate data and instructions. Thus, the programmer can be used to adjust the programmed therapy provided by the IMD, and the IMD can report device data (such as battery and lead resistance) and therapy data (such as sense and stimulation data) to the programmer using radio telemetry, for example. According to various embodiments, the IMD stimulates/inhibits a neural target using non-selective vagus nerve stimulation delivered using a predetermined schedule and with schedule parameter(s) selected to avoid physiological habituation to the vagus nerve stimulation.
[0066] The external system allows a user such as a physician or other caregiver or a patient to control the operation of the 1 MB and obtain information acquired by the 1 MB. In one embodiment, external system includes a programmer communicating with the IMD bi-directionally via a telemetry link. In another embodiment, the external system is a patient management system including an external device communicating with a remote device through a telecommunication network. The external device is within the vicinity of the IMD and communicates with the 1 MB bi-directionally via a telemetry link. The remote device allows the user to monitor and treat a patient from a distant location. The patient monitoring system is further discussed below.
[0067] The telemetry link provides for data transmission from implantable medical device to external system. This includes, for example, transmitting real-time physiological data acquired by IMD, extracting physiological data acquired by and stored in IMD, extracting therapy history data stored in implantable medical device, and extracting data indicating an operational status of the IMD (e.g., battery status and lead impedance). Telemetry link also provides for data transmission from external system to 1 MB. This includes, for example, programming the 1 MB to acquire physiological data, programming 1 MB to perform at least one self-diagnostic test (such as for a device operational status), and programming the IMD to deliver at least one therapy.
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