# Patent

## Title
Device and method for the treatment of breathing disorders and cardiac disorders

## Abstract

The present invention is related to an implantable medical device for treating breathing disorders and cardiac disorders by delivering stimulation energy to the phrenic nerve, hypoglossal nerves and cardiac muscle tissues.

## Background
CROSS REFERENCE TO RELATED CASES
The present case claims the benefit of U.S. Provisional Application 60/881,695 filed Jan. 22, 2007 entitled Transvenous Stimulation of Hypoglossal Nerve to Treat Central and Obstructive Sleep Apnea. The disclosure of the provisional application is incorporated by reference.


FIELD OF THE INVENTION
An implantable medical device and a method carried out with an implantable medical device for the treatment of sleep apnea and for the treatment of sleep apnea in patients with cardiac disorders.
BACKGROUND OF THE INVENTION
Sleep apnea (SA) is a disease state in which the patient exhibits periodic breathing. Sleep apnea is typically characterized as either “obstructive” (OSA) or “central” (CSA). Many patients exhibit the disorder in both of its forms, OSA and CSA. OSA is traditionally treated by attempting to maintain patency of the upper airway. CSA is traditionally treated by stimulation of the diaphragm. Sleep apneas occur with high frequency in patients with cardiac rhythm disorders that might be treated with bradycardia treatment or biventricular pacemakers.
SUMMARY
The present invention includes a method, device, and system for treatment of SA breathing. The system includes one or more transvenous leads coupled to an implanted medical device, where one lead system is positioned to stimulate a muscle group. An additional lead system is positioned to stimulate at least one nerve. In an alternative embodiment of the device, the two lead systems both stimulate nerves. In this alternative embodiment, one set of nerves leads to muscle contraction and the other set of nerves do not lead to muscle contraction but they locally alter the “tone” of the nervous system.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 depicts the system in schematic form;
FIG. 2 depicts a process carried out in the implanted device;
FIG. 3 depicts a process carried out in the implanted device;
FIG. 4 depicts a device in accordance with embodiments of the invention.



DETAILED DESCRIPTION OF THE INVENTION
The nervous system (NS) is exceedingly complex. Two main components of the NS are the sympathetic NS and the parasympathetic NS. It is widely held that these two systems counteract each other and a homeostatic balance is achieved between them. It is recognized that the relative activation of the two systems results in a “tone” that that varies between waking and sleeping states.
Without elucidating a complete mechanism of action, the inventors completed a course of experimentation that suggests to them that transvenous stimulation near the base of the tongue, near the location of the hypoglossal nerves, increases airflow during apnea with out actually provoking activation of muscle tissue near the stimulation site. Applicants believe that this sub-threshold stimulation alters “tone”. It should be understood that the measurement of tone is fraught with technical difficulties; However, the inventors believe that the periodic and episodic application of electrical currents at voltages and currents far below the levels required for evoked muscle contraction of tissue near the tongue are responsible for an increase in the diameter of the airway passages and increase ventilation in patients. The inventors believe that episodic background simulation may increase the otherwise prevailing level of tone and that this level of stimulation is compatible with restful sleep and will not arouse a sleeping patient. In each embodiment of the inventors' system low-level stimulation is travenously delivered to nerves and muscles near the hypoglossal tissues of a patient.
FIG. 1 depicts an implanted medical device 10 (IMD) of the type necessary to carry out the invention. The IMD 10 is coupled to a first transvenous lead system 12 located in the area of the tongue near the hypoglossal nerves represented schematically at reference numeral 17 and placing stimulation electrodes typified by electrode 23 in a vein or artery 13 near the hypoglossal nerves 17. A second lead system 14 couples the IMD 10 transvenously to the phrenic nerve and diaphragm represented schematically at reference numeral 19. Once again stimulation electrodes are placed near the phrenic nerve as indicated schematically at reference numeral 25. A third lead system 16 places a pacing lead 20 in the right ventricle RV and a pacing lead 18 positioned to stimulate the left ventricle LV of the heart 21.
The IMD 10 contains conventional circuitry to detect the patients R-wave and impedance plythesmographic detectors to find the mid breath point in the respiration cycle. The IMD 10 also contains an activity sensor to measure the activity level of the patient. This activity sensor may be used to detect periods of sleep. These sense amplifiers, stimulation pulse generators, activity monitors, and impedance monitors are structures that are not described in detail as they are well known to those skilled in this art.
Pacing Embodiment
The transvascular subtheshold low level stimulation of the hypoglossal tissues near the upper airways may be combined with conventional bradycardia pacing therapies. Applicants describe a device that combines low-level transvascular stimulation with a conventional pacing regime or modality. Although the invention is applicable to both biventricular lead placements as well as cardiac defibrillator lead placements, the invention is described in the context of a biventricular demand mode pacemaker. It must be understood that other bradycardia and tachycardia treatment modalities are contemplated and are within the scope of the claims. The choice of the depicted modality is selected for simplicity and because it is indicated for patients likely to also suffer from sleep apnea.
During periods of pacing support of the patient's rhythm the IMD 10 will also delivers stimulation energy to the hypoglossal tissues via the transvenous lead 12. The stimulation energy delivered may be continuous or intermittent at an appropriate relatively low frequency duty cycle.
At times when the patient's detected activity is low, the IMD may deliver background stimulation from an appropriate pulse generator within the IMD 10 through the lead system 12 at a level insufficient to arouse the patient from sleep.
FIG. 2 is a flowchart depicting representative implementation of the integration of very low energy transvascular hypoglossal stimulation with brady pacing. The process starts with block 100. In decision block 120 the presence or absence of an R-wave is determined with a sense amplifier within the IMD 10. If an R-wave is detected (yes in process 120), the process 120 resets the pacing escape interval timer and returns to the start of R-wave detection process 120. If an R-wave does not occur within an escape interval (no in process 120), the process moves to process 122 where patient activity is monitored. If the patient is inactive (no in process 122), perhaps asleep, and in need of ventricular stimulation, then the processes 124 activates the low level hypoglossal tissues via lead system 12 while process 126 activates the biventricular pulse generators to delivery stimulation on leads 18 and 20. In this fashion the patient receives the low level hypoglossal stimulation in phase with pacing therapy. Other variations in stimulation patterns are possible as well.
Respiration Embodiment
The IMD 10 is equipped to detect respiration and deliver stimulation to the phrenic nerve via lead system 14 at times and stimulation magnitudes to “hold” the breath of a patient. This breath holding attribute tends to decrease breathing rate and has been proposed by the inventors as a treatment for central sleep apnea.
In this embodiment low-level electrical stimulation of the tissues near the hypoglossal nerve is invoked and delivered at the time that phrenic nerve receives stimulation. FIG. 3 depicts a representative implementation of a software process carried out within the IMD 10 to treat a patient. In the start process 101 the IMD 10 turns on the respiration sensor system, and in process 130 the IMD finds the mid-breath point. If appropriate (yes in process 130), the IMD enters process 132 where pulse generators within the IMD deliver phrenic nerve stimulation via lead system 14 in synchrony with the mid breath respiration point. The device moves to process 134 where low-level hypoglossal stimulation is delivered via lead system 12. In this fashion low-level electrical energy is delivered to the upper airway to improve patency during a breath. In this way the invention overcomes limitations of prior art that require:

    
    
        1. surgical placement of nerve stimulation electrodes on the nerve
        2. synchronized stimulation that requires contraction of selected airway muscles prior and during natural inspiration phase of the breath
        3. discomfort to the patient caused by stimulation of small muscles in the head and neck
    
    


Stimulation pulses are applied during the inspiratory phase of the breath. The inspiratory phase can be initiated by the patient or by the logic of the IMD in response to sensed apnea. Stimulation of hypoglossal nerve can be applied in synchrony with stimulation of the phrenic nerve. Stimulation of the hypoglossal nerve can be applied slightly ahead of the stimulation of the phrenic nerve to prevent airway collapse that is a known side effect of phrenic stimulation.
Another variation of the respiration embodiment involves a step-wise sequence including the steps of:

    
    
        a. locating a transvenous stimulation electrode near the hypoglossal nerve;
        b. locating a transvenous stimulation electrode near the phrenic nerve;
        c. detecting the respiration of the patient;
        d. supplying stimulation to the hypoglossal transvenous stimulation electrode to maintain patency of the airway during a breath;
        f. supplying stimulation to the phrenic nerve transvenous stimulation electrode to extend the duration of a breath.
    
    


Yet another variation of the respiration embodiment involves a step-wise sequence including the steps of:

    
    
        a. locating a transvenous stimulation electrode near the hypoglossal nerve;
        b. locating a transvenous stimulation electrode near the phrenic nerve;
        c. detecting the respiration of the patient;
        d. supplying stimulation to the hypoglossal transvenous stimulation electrode to maintain patency of the airway during a breath;
        e. supplying stimulation to the phrenic nerve transvenous stimulation electrode to extend the duration of a breath;
        f. supplying the stimuli of d. and e. sequentially to initiate a breath.
    
    


FIG. 4 is a schematic diagram showing an implanted medical device (IMD) 10 that can be an IPG implantable pulse generator implanted in a patient's chest for carrying out a therapeutic stimulation of hypoglossal nerve 105. The device 10 is equipped with the lead 102 that transvenously places the electrode 103 in the ranine vein 104. In this embodiment there are two electrodes for bipolar stimulation.
The lead 102 passes through the jugular vein 106. The IMD 10 can be equipped with other stimulation and sensing leads such as: leads to stimulate phrenic nerve, leads to pace the heart, leads to apply defibrillation pulses, leads to sense respiration. The IMD is equipped with embedded logic that allows sensing of respiratory activity and application of synchronized stimulation pulses to electrodes.

## Claims

1. An implantable medical device for treating a patient comprising;
a. a stimulator configured to provide electrical stimulation to a first lead system and a second lead system,
b. said first lead system configured to transvenously place a stimulation electrode in a ranine vein near the patient's hypoglossal nerve and including a processor configured to deliver electrical stimulation to the electrode in the ranine vein near the patient's hypoglossal nerve;
c. said second lead system configured to transvenously place a stimulation electrode near the patient's phrenic nerve and wherein the processor is further configured to deliver electrical stimulation to the electrode near the patient's phrenic nerve; and
d. the stimulator being configured to provide the electrical stimulation to the first lead system slightly before applying electrical stimulation to the second lead system.

2. The device of claim 1, wherein said stimulator is configured to supply sub threshold stimulation periodically to said first lead system to alter hypoglossal tone to a value near the value of tone during the awake state.

3. The device of claim 1, wherein said stimulator is configured to supply sub threshold stimulation periodically to said first lead system to alter tone where the level of sub threshold stimulation is selected not to arouse the patient.

4. The device of claim 1, wherein said stimulator is configured to supply sub threshold stimulation periodically to said first lead system to elevate upper airway muscle tone where level of sub threshold stimulation is selected such that the patient is not aware of stimulation while patient is awake.

5. The device of claim 1, wherein the stimulator is configured to provide the electrical stimulation to the second lead system at a defined interval.

6. An implantable medical device for treating a patient comprising:
a. a stimulator configured to provide electrical stimulation to a lead system that includes a stimulation electrode: and
b. the lead system configured to transvenously place the stimulation electrode in a lingual vein near the patient's hypoglossal nerve and including a processor configured to deliver electrical stimulation to the electrode in the lingual vein near the patient's hypoglossal nerve;
c. wherein the stimulator is configured to stimulate the hypoglossal nerve from the lingual vein.

7. The device of claim 6, wherein the stimulator is configured to supply sub threshold stimulation periodically to the lead system to alter hypoglossal tone to a value near the value of tone during the awake state.

8. The device of claim 6, wherein the stimulator is configured to sub threshold stimulation periodically to the lead system to alter tone where the level of sub threshold stimulation is selected not to arouse the patient.

9. The device of claim 6, wherein said stimulator is configured to supply sub threshold stimulation periodically to the lead system to elevate upper airway muscle tone where level of sub threshold stimulation is selected such that the patient is not aware of stimulation while patient is awake.

10. The device of claim 6, further comprising a second lead system configured to transvenously place a stimulation electrode near the patient's phrenic nerve and wherein the processor is further configured to deliver electrical stimulation to the electrode near the patient's phrenic nerve; and the stimulator being configured to provide the electrical stimulation to the lead system configured to transvenously place the stimulation electrode in a lingual vein slightly before applying electrical stimulation to the second lead system.