In cases in which sleep disordered breathing is caused by upper airway obstructions, one form of treatment includes stimulating one or more nerves that affect upper airway dilation. In a conventional technique, the stimulation is applied continuously or synchronized to the respiratory cycle. However, in some instances, continuous stimulation may not desirable because of any potential long-term effects of over-stimulating the nerve.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
In the following Detailed Description, reference is made to the accompanying drawings which form a part hereof, and in which is shown specific examples of the present disclosure which may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of examples of the present disclosure can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other examples may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense.
At least some examples of the present disclosure are directed to methods of treating obstructive sleep apnea via applying stimulation in intervals or periods during targeted portions of the respiratory cycle. By doing so, upper airway patency is maintained and/or increased while preventing collapse of the upper airway. At the same time, by using targeted stimulation, one can limit the overall volume of stimulation applied to a given nerve or set of nerves.
In some embodiments, the sensor portion 40 detects respiratory effort including respiratory patterns (e.g., inspiration, expiration, respiratory pause, etc.) in order to trigger activation of an electrode portion to stimulate a target nerve. Accordingly, with this arrangement, the IPG 35 (
In some embodiments, the sensor portion 40 is a pressure sensor. In one example, the pressure sensor in this embodiment detects pressure in the thorax of the patient. In other examples, the sensed pressure could be a combination of thoracic pressure and cardiac pressure (e.g., blood flow). With this configuration, the controller is configured to analyze this pressure sensing information to detect the respiratory patterns of the patient.
In some other embodiments, the respiratory sensor portion 40 comprises a bio-impedance sensor or pair of bio-impedance sensors and can be located in regions other than the pectoral region. In one aspect, such an impedance sensor is configured to sense a bio-impedance signal or pattern whereby the control unit evaluates respiratory patterns within the bio-impedance signal. For bio-impedance sensing, in one embodiment, electric current will be injected through an electrode portion within the body and an electrically conductive portion of a case of the IPG 35 (
In some embodiments, system 10 also comprises additional sensors to further obtain physiologic data associated with respiratory functions. For example, system 10 may include various sensors (e.g., sensors 47, 48, 49 in
In some embodiments, the sensing and stimulation system for treating obstructive sleep apnea is a totally implantable system which provides therapeutic solutions for patients diagnosed with obstructive sleep apnea. In other embodiments, one or more components of the system are not implanted in a body of the patient. A few non-limiting examples of such non-implanted components include external sensors (respiration, impedance, etc.), an external processing unit, or an external power source. Of course, it is further understood that the implanted portion(s) of the system provides a communication pathway to enable transmission of data and/or controls signals both to and from the implanted portions of the system relative to the external portions of the system. The communication pathway includes a radiofrequency (RF) telemetry link or other wireless communication protocols.
Whether partially implantable or totally implantable, the system is designed to stimulate the hypoglossal nerve during some portion of the repeating respiratory cycle to thereby prevent obstructions or occlusions in the upper airway during sleep. In one embodiment, the implantable system comprises an implantable pulse generator (IPG), a peripheral nerve cuff stimulation lead, and a pressure sensing lead.
Via an array of parameters, the sensing module 66 receives and tracks signals from various physiologic sensors (such as a pressure sensor, blood oxygenation sensor, acoustic sensor, electrocardiogram (ECG) sensor, or impedance sensor) in order to determine a respiratory state of a patient, whether or not the patient is asleep or awake, and other respiratory-associated indicators, etc. Such respiratory detection may be received from either a single sensor or any multiple of sensors, or combination of various physiologic sensors which may provide a more reliable and accurate signal. In one example, sensing module 90 receives signals from sensor portion 40 and/or sensors 47, 48, 49 in
In one example, a controller 62 of IPG 60 comprises one or more processing units and associated memories configured to generate control signals directing the operation of IPG 60 and system 10 (
For purposes of this application, in reference to the controller 62, the term “processor” shall mean a presently developed or future developed processor (or processing resources) that executes sequences of machine readable instructions (such as but not limited to software) contained in a memory. Execution of the sequences of machine readable instructions causes the processor to perform actions, such as operating IPG 60 to provide apply stimulation to a nerve in the manner described in the examples of the present disclosure. The machine readable instructions may be loaded in a random access memory (RAM) for execution by the processor from their stored location in a read only memory (ROM), a mass storage device, or some other persistent storage or non-volatile form of memory, as represented by memory 64. In one example, memory 64 comprises a computer readable medium providing non-transitory or non-volatile storage of the machine readable instructions executable by a process of controller 62. In other examples, hard wired circuitry may be used in place of or in combination with machine readable instructions (including software) to implement the functions described. For example, controller 62 may be embodied as part of at least one application-specific integrated circuit (ASIC). In at least some examples, the controller 62 is not limited to any specific combination of hardware circuitry and machine readable instructions (including software), nor limited to any particular source for the machine readable instructions executed by the controller 62.
With this in mind, in general terms the therapy manager 72 acts to synthesize respiratory information, to determine suitable stimulation parameters based on that respiratory information, and to direct electrical stimulation to the target nerve.
In one example, among other components, therapy manager 72 includes a stimulation protocol determination module 74.
In one example, the stimulation protocol determination module 74 includes an input function 76 and a selector function 78. In general terms, the input function receives an indication of an upper airway flow limitation that is sensed via respiratory effort information. In one example, input function 76 includes a flow limitation parameter 80 and a respiratory effort parameter 82.
In one example, the flow limitation parameter 80 detects and tracks when a flow limitation is present in the upper airway of a patient. In one aspect, the flow limitation parameter 80 tracks the degree and/or duration of flow limitation. Various examples of recognizing a flow limitation are further described below in association with at least
In one example, the respiratory effort parameter 82 detects and tracks respiratory effort information obtained via sensing respiratory information such as, but not limited to, the respiratory sensing methods previously described above in association with
As noted above, the therapy manager 72 also includes a selector function 78, which in general terms, enables the IPG 60 to select an appropriate stimulation protocol that is responsive to a particular type of upper airway flow limitation. In one example, the selector function 78 includes a respiratory phase parameter 84 and a protocol array parameter 86. The respiratory phase parameter 84 determines which respiratory phase or phases, or portions of the respective phases, in which stimulation should be applied. In one aspect, these determinations are made based on the ongoing sensing of respiratory effort, with the sensed information being received by input function 76.
The protocol array parameter 86 provides an array of stimulation protocols suitable for delivering to a nerve of a patient, depending upon the type, degree, and/or duration of a flow limitation. The protocol array parameter 86 does so in cooperation with respiratory phase parameter 84 and input function 76.
Specific examples of treating disordered breathing via the therapy manager 72, and in particular, treating upper airway flow limitations (i.e. obstructions) via the functions, components, parameters, and/or features of protocol determination module 74 of therapy manager 72 are further described and illustrated below in association with
In general terms, the stimulation module 68 of IPG 60 is configured to generate and apply a neuro-stimulation signal via electrode(s) (such as stimulation electrode(s) 45 in
In general terms, the patient management module 70 is configured to facilitate communication to and from the IPG 60 in a manner familiar to those skilled in the art. Accordingly, the patient management module 70 is configured to report activities of the IPG 70 (including sensed physiologic data, stimulation history, number of apneas detected, etc.) and is configured to receive initial or further programming of the IPG 60 from an external source, such as a patient programmer, clinician programmer, etc.
In one example, as shown in
As shown in
However, in some examples, when the flow limitation occurs predominantly during (i.e. coincides with) a portion of inspiration and a portion of expiration (at 108), the stimulation is applied during some portion of inspiration and some portion of expiration (at 114).
In one example, when the flow limitation overlaps the transition between the end of inspiration and the beginning of expiration, the stimulation will be applied to overlap the transition between the end of inspiration and the beginning of expiration.
In another example, when the flow limitation occurs during a portion of inspiration and a portion of expiration (at 108), the stimulation is applied to cover an entire respiratory cycle, including an entire inspiratory phase and an entire expiratory phase.
In order to recognize a flow limitation, the method 100 uses as a reference point a normal breathing pattern 150, as shown in
In the example of normal breathing pattern 150 shown in
In one example, the various stimulation protocols described and illustrated in association with
It will be understood that, in one example, the detection of flow limitations and/or associated apneas), as well as the detection of the beginning and end of the respective inspiratory and expiratory phases of the respiratory cycle to enable determining when to stop or start stimulation, is performed according to, or in cooperation with, known methods and devices for doing so. Some non-limiting examples of such devices and methods to recognize and detect the various features and patterns associated with respiratory effort and flow limitations include, but are not limited to: PCT Publication WO/2010/059839, titled A METHOD OF TREATING SLEEP APNEA, published on May 27, 2010; Christopherson U.S. Pat. No. 5,944,680, titled RESPIRATORY EFFORT DETECTION METHOD AND APPARATUS; and Testerman U.S. Pat. No. 5,522,862, titled METHOD AND APPARATUS FOR TREATING OBSTRUCTIVE SLEEP APNEA.
However, as shown in
In one embodiment, application of the stimulus occurs at an inspiratory phase (
In one aspect,
In another aspect, disordered breathing pattern 283A also includes an expiratory phase 292A having a peak 297A corresponding to an amplitude or peak pressure that is substantially smaller than a peak 177 of an expiratory phase 170 in a normal breathing pattern 150 (
In one example, the indicated upper airway flow limitation predominantly coincides with both of a first portion of the inspiratory phase and a first portion of the expiratory phase. In another aspect, this indicated flow limitation does not predominantly coincide with a second portion of inspiratory phase and with a second portion of the expiratory phase.
However, via application of blended stimulation (symbolically represented by bar 300) directed to at least a portion of the inspiratory phase and a portion of the expiratory phase, the flow limitations are mitigated. As shown in treated breathing pattern 283B, a latter segment 285C of intermediate portion 285B (and end portion 286B) resumes a more parabolic shape better resembling a baseline inspiratory phase prior to the flow limitation and that corresponds to amelioration of the “inspiratory” flow limitation.
Likewise, because this stimulation overlaps from the inspiratory phase 282B into the expiratory phase 292B, the treated breathing pattern 283B exhibits a peak 297B approaching a baseline amplitude prior to the flow limitation (like amplitude 177 in the expiratory phase 170 of normal breathing pattern 150 of
In one embodiment, the stimulation is represented by bar 300, which extends from a first end 301 (in the inspiratory phase 282B) to a second end 303 (in the expiratory phase 292B). The stimulation is applied as a generally continuous stimulation period that is initiated (at a start point located away from a beginning portion 284B of the inspiratory phase 252B) from partway through the intermediate portion 285B and through the end portion 285C of the inspiratory phase 282B, through the transition from inspiration to expiration, through the initial portion 294B and peak 297A of the expiratory phase 292B, and at least partway through the intermediate portion 295B of the expiratory phase 292B (to a termination point prior to end portion 296B of expiratory phase 292B).
In one example, the embodiment of
Further, it will be understood that diagram 280 in
Accordingly, applying this blended stimulation overcomes expiratory narrowing, which otherwise might render the upper airway vulnerable to complete collapse during a subsequent inspiratory effort.
Without being bound to any particular theory, it is believed that the blended stimulation that overlaps the end of inspiratory phase and the expiratory phase acts to maintain a minimum level of pressurization within the lungs, which in turn helps maintain airway patency because the minimum level of pressurization helps to prevent a high intensity vacuum from the lungs on the airway, which would otherwise potentially cause collapse of the upper airway.
In this way, for some patients, the stimulation is applied during a period having a higher risk for collapse without having to continuously apply stimulation through the entire respiratory cycle, which in turn, saves energy and minimizes potentially unnecessary stimulation of the nerves.
In one example of a stimulation protocol, such as the one described and illustrated in association with
In one example, the first time period (over which the set of respiratory cycles take place) is a duration, based on an apnea-hypopnea index of a patient, in which an apnea would be expected to occur in the absence of stimulation.
As a reference point for illustrating the generally continuous stimulation period,
According to one example of the present disclosure,
As further demonstrated by
In one example, the first portion 360 of the generally continuous stimulation period 358 has a duration of at least one-third (identified by marker 372) of an entirety (E1) of the inspiratory phase 162. In one aspect, the relative proportion of one-third is measured starting at end 362 of bar 361, per directional reference arrow 357. In another example, the first portion 360 of the generally continuous stimulation period 358 has a duration of at least one-half (identified by marker 370) of the entirety (E1) of the inspiratory phase 162. In another example, the first portion 360 of the generally continuous stimulation period 358 has a duration of at least two-thirds (identified by marker 374) of the entirety (E1) of the inspiratory phase 162
In another example, the second portion 380 of the generally continuous stimulation period 358 has a duration of at least one-third (identified by marker 392) of an entirety (E2) of the expiratory phase 170. In one aspect, the relative proportion of one-third is measured starting at end 382 of bar 381, per directional reference arrow 377. In another example, the first portion 380 of the generally continuous stimulation period 358 has a duration of at least one-half (identified by marker 390) of the entirety (E2) of the expiratory phase 170. In another example, the first portion 380 of the generally continuous stimulation period 358 has a duration of at least two-thirds (identified by marker 393) of the entirety (E2) of the expiratory phase 170.
In one example, the first portion (during which stimulation is applied) of the inspiratory phase 162 corresponds to at least a majority of an entirety (E1) of the inspiratory phase 162 and the first portion (during which stimulation is applied) of the expiratory phase 170 corresponds to at least a majority of an entirety (E2) of the expiratory phase 170. In one example, a majority is defined as at least fifty-one percent (i.e. 51%). In another example, the majority of the inspiratory phase 162 is defined as an at least two-thirds majority of the entirety (E1) of the inspiratory phase 162 and the majority of the expiratory phase is defined as an at least two-thirds majority of the entirety (E2) of the expiratory phase 170.
In one example, variations on the stimulation protocol associated with
In another embodiment, as shown in
Without being bound to any particular theory, it is believed that by applying a stimulation burst (e.g., an additional stimulation burst on top of a baseline level of stimulation or an isolated burst of stimulation without a baseline level of stimulation) at the beginning of the inspiratory phase, the stimulation causes or ensures radial expansion of the airway at the very time that a high intensity vacuum would be applied (via the lungs) to the upper airway such that the radial expansion of the upper airway (caused by the stimulation burst) directs action or response of tissues in a direction opposite the action of tissue that would might otherwise occur when the vacuum from lungs acts on the upper airway tissues. Accordingly, the stimulation is timed to produce momentum in the tissues of the upper airway toward radial expansion prior to the high intensity vacuum pull (which might otherwise contribute to collapse of the upper airway) from the lungs during the onset of inspiration. Because there is a delay associated with, or caused by, a time constant in the response of the upper airway tissues, by first stimulating the tissue in advance of the vacuum pull from the lungs, enough momentum is established toward radial expansion of the upper airway via the stimulation burst that this momentum counteracts or prophylactically negates the otherwise potentially collapsing effects of the vacuum pull on the upper airway tissues.
In one aspect, by applying stimulation in this manner, it is believed that airway patency is maintained with less overall stimulation being applied because stimulation is applied strategically within one or more respiratory cycles rather than indiscriminately through entire respiratory cycles. With this in mind, in one embodiment the total combined duration of burst 340 and burst 342 (shown in
In some embodiments in which separate bursts of stimulation are applied to the inspiratory and expiratory phases, respectively, the duration of the bursts in the inspiratory phase differ from the duration of the burst applied in the expiratory phase. For example, as shown in the diagram 400 of
In one aspect, the determination regarding the duration of each “inspiratory phase” burst (420A, 420B, 420C) and the duration of each “expiratory phase” burst (422A, 422B, 422C) can vary from patient-to-patient depending upon whether the particular patient tends to exhibit a greater flow limitation in the inspiratory phase 403A or in the expiratory phase 413A. In the example, shown in
In one embodiment, anyone of or all of an amplitude, a pulse width, a frequency of applied stimulation during the inspiratory phase is different than anyone of (or all of) an amplitude, a pulse width, a frequency of applied stimulation during the expiratory phase. In addition, a ramped stimulation pattern in which stimulation ramps upward (increases) at the beginning of a stimulation period or ramps downward at the end of a stimulation period, can be applied in one or both of the inspiratory and expiratory phases.
In some embodiments, as shown in
In yet other embodiments, other forms of alternating stimulation bursts are applied. For example, in one pattern of stimulation, a low amplitude continuous pulsed stimulation is applied and one or more relatively shorter duration stimulation bursts are applied in a targeted and additive manner to the low amplitude continuous stimulation.
As further shown in the diagram 450 of
Without being bound by any particular theory, it is believed that using a burst of stimulation (for example, burst 475 in
In one embodiment, the stimulation pattern in
As further shown in
In some embodiments, the moment at which stimulation burst is initiated (within a given inspiratory phase or give expiratory phase) is optimized so that no surplus stimulation is applied. For example, in an example in which a patient has a mixed flow limitation, and a single longer stimulation burst is applied that overlaps both the inspiratory phase and the expiratory phase (such as shown in
With further reference to
Using these parameters, therapy is applied through a period of time to observe whether the applied stimulation is efficacious. In the event that the stimulation period (segments 630 and 640) within the respiratory cycle is sufficient to ameliorate the sleep disordered breathing, the method begins to scale back the total duration of the stimulation period (segments 630, 640). Accordingly, the start point of stimulation segment 630 is moved to point B, corresponding to a shorter period of stimulation (in the inspiratory phase 601), and therapy is applied for a period of many respiratory cycles while observing whether the shortened duration of stimulation is efficacious. This adjustment process is continued in which the duration of stimulation segment 630 in the inspiratory phase 601 is reduced one step at a time (as represented by directional arrow R), until a start point (e.g. A, B, C, D, E, etc.) is identified at which the inspiratory-phase stimulation segment 630 becomes too short as evidenced by the stimulation starting to lose its effectiveness in maintaining and/or restoring airway patency. In other words, the start point is moved in decrements closer to the end portion of the inspiratory phase until a loss of efficacious stimulation therapy is identified.
In one example, once the start point has been adjusted by a decrement (one step), the new duration is maintained for a set of consecutive respiratory cycles to provide a sufficient period of time over which to evaluate the new settings.
With this information, one can identify the last initiation point at which the desired effectiveness was achieved, and this point is adopted as the optimal start point for stimulation segment 630 in the inspiratory phase 610 for this patient. For example, if the start point D resulted in a stimulation segment 630 that proved ineffective in maintaining or restoring airway patency, while start point C was the last successful start point, then the optimal stimulation segment 630 would have a start point C. Once the optimal start point is adopted, each stimulation segment 630 within a give respiratory cycle 603 would begin at start point C.
In one example, the size of the decrements or steps between the respective start points (A, B, C, etc.) correspond to a fraction (such as 1/10, ⅕, or ⅛, etc. of the entire duration of the first portion 360 of the stimulation period 358.
In another example, the initial starting point (e.g. A) is selected to correspond to one of the example durations (two-thirds, one-half, or one-third) of the first portion 360 of the generally continuous stimulation period 358 shown in
A similar method is applied to the expiratory phase 611 such that the optimal termination point of the stimulation period (segments 630 and 640) is determined for a given respiratory cycle. In doing so, an initial termination point (e.g. point F) for stimulation segment 640 is identified, and therapy is applied. Provided that efficacy was achieved, the method continues by adopting an earlier termination point (e.g. point G), corresponding to a shorter period of stimulation (in the expiratory phase 611), and therapy is applied for a period of time covering many respiratory cycles. The response of the patient is observed to determine if any loss of efficacy has occurred due to shortening the stimulation segment 640. This process is continued in which the duration of stimulation 640 in the expiratory phase 611 is reduced one step at a time (as represented by directional arrow T), until a termination point (anyone of points F, G, H, I, J, K, etc.) is identified at which the expiratory-phase stimulation 640 becomes too short as evidenced by the stimulation starting to lose its effectiveness in maintaining and/or restoring airway patency. In other words, the termination point is moved in decrements closer to the beginning portion of the expiratory phase until a loss of efficacious stimulation therapy is identified.
With this information, one can identify the last termination point at which the desired effectiveness was achieved, and this point is adopted as the optimal termination point of stimulation segment 640 for this patient to overcome the mixed flow limitation (i.e. a flow limitation that overlaps both the inspiratory and the expiratory phases 601, 611).
In one example, once the termination point has been adjusted by a decrement (one step), the new duration is maintained for a set of consecutive respiratory cycles to provide a sufficient period of time over which to evaluate the new settings.
In one example, the size of the decrements or steps between the respective termination points (F, G, H, etc.) corresponds to a fraction (such as 1/10, ⅕, or ⅛, etc. of the entire duration of the second portion 380 of the stimulation period 358.
In another example, the initial starting point (e.g. F) is selected to correspond to one of the example durations (two-thirds, one-half, or one-third) of the second portion 380 of the generally continuous stimulation period 358 shown in
It will be understood, that in addition to optimizing the duration of the stimulation segments 630, 640 shown in association with
In some embodiments, an implantable stimulator also can be operated in a first mode which attempts to maintain airway patency (and is therefore prophylactic) or a second mode, which recovers airway patency that has been lost. In the first mode, a stimulation pattern is applied that uses the minimum amount of stimulation required to maintain airway patency, and may include (but is not limited to) one of the stimulation patterns previously described and illustrated in association with
In some embodiments, a flow limitation in the upper airway is detected via respiratory sensors and/or pressure sensors to determine a relative degree of obstruction. These sensors also can be used to determine whether the obstruction is occurring during inspiration, during expiration, or during both. Moreover, because each type of obstruction yields a pressure/impedance pattern that is characteristic of the particular type of obstruction, one can use this sensing information to determine an efficacious stimulation pattern.
In some embodiments, a stimulation pattern mimics the pattern of the particular breathing phase. As shown in
Meanwhile, in some embodiments, a ramped stimulation pattern 690 is applied to the expiratory phase 661 as further shown in
In this embodiment, stimulation is applied in bursts 734 in the early portion of the inspiratory phase 701 to maintain tone of the upper airway and then continuous stimulation 735 is applied during the latter half of the inspiratory phase 701 when maximum air flow would occur and just prior to expiration when the airway could be at greater risk for collapse. On the other hand, in the expiratory phase 711, continuous stimulation 743 is applied during the first half of the expiratory phase when there is a greater risk of airway collapse (and maximum air flow needs to take place) while bursts 745 of stimulation are applied during the second half of the expiratory phase 711 to maintain tone and nominal airway patency.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this present disclosure be limited only by the claims and the equivalents thereof.
This Continuation Patent Application claims benefit of U.S. National Stage application Ser. No. 14/238,359, entitled “Nerve Stimulation Protocol Determination” filed Oct. 14, 2014, PCT/US12/50615, entitled “System for Selecting a Stimulation Protocol Based on Sensed Respiratory Effort” filed Aug. 13, 2012, and Provisional U.S. Patent Application No. 61/522,426, entitled “Method and System for Applying Stimulation in Treating Sleep Disordered Breathing,” filed Aug. 11, 2011, all of which are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
4379462 | Borkan et al. | Apr 1983 | A |
4567892 | Plicchi et al. | Feb 1986 | A |
4630614 | Atlas | Dec 1986 | A |
4813431 | Brown | Mar 1989 | A |
4830008 | Meer | May 1989 | A |
5133354 | Kallok | Jul 1992 | A |
5134995 | Gruenke et al. | Aug 1992 | A |
5148802 | Sanders et al. | Sep 1992 | A |
5158080 | Kallok | Oct 1992 | A |
5167229 | Peckham et al. | Dec 1992 | A |
5174287 | Kallok et al. | Dec 1992 | A |
5178156 | Takishima et al. | Jan 1993 | A |
5203343 | Axe et al. | Apr 1993 | A |
5211173 | Kallok et al. | May 1993 | A |
5215082 | Kallok et al. | Jun 1993 | A |
5233983 | Markowitz | Aug 1993 | A |
5239995 | Estes et al. | Aug 1993 | A |
5245995 | Sullivan et al. | Sep 1993 | A |
5265624 | Bowman | Nov 1993 | A |
5281219 | Kallok | Jan 1994 | A |
5300094 | Kallok et al. | Apr 1994 | A |
5335657 | Terry, Jr. et al. | Aug 1994 | A |
5344438 | Testerman et al. | Sep 1994 | A |
5351394 | Weinberg | Oct 1994 | A |
5385144 | Yamanishi et al. | Jan 1995 | A |
5388578 | Yomtov et al. | Feb 1995 | A |
5398682 | Lynn | Mar 1995 | A |
5458137 | Axe et al. | Oct 1995 | A |
5483969 | Testerman et al. | Jan 1996 | A |
5485851 | Erickson | Jan 1996 | A |
5522862 | Testerman et al. | Jun 1996 | A |
5524632 | Stein et al. | Jun 1996 | A |
5540731 | Testerman | Jul 1996 | A |
5540732 | Testerman | Jul 1996 | A |
5540733 | Testerman et al. | Jul 1996 | A |
5540734 | Zabara | Jul 1996 | A |
5546952 | Erickson | Aug 1996 | A |
5549655 | Erickson | Aug 1996 | A |
5588439 | Hollub | Dec 1996 | A |
5591216 | Testerman et al. | Jan 1997 | A |
5605151 | Lynn | Feb 1997 | A |
5645053 | Remmers et al. | Jul 1997 | A |
5671733 | Raviv et al. | Sep 1997 | A |
5797852 | Karakasoglu et al. | Aug 1998 | A |
5823187 | Estes et al. | Oct 1998 | A |
5843135 | Weijand et al. | Dec 1998 | A |
5895360 | Christopherson et al. | Apr 1999 | A |
5904141 | Estes et al. | May 1999 | A |
5919221 | Miesel | Jul 1999 | A |
5944680 | Christopherson et al. | Aug 1999 | A |
5999846 | Pardey et al. | Dec 1999 | A |
6015389 | Brown | Jan 2000 | A |
6021352 | Christopherson et al. | Feb 2000 | A |
6025624 | Figura | Feb 2000 | A |
6041780 | Richard et al. | Mar 2000 | A |
6099479 | Christopherson et al. | Aug 2000 | A |
6120441 | Griebel | Sep 2000 | A |
6125290 | Miesel | Sep 2000 | A |
6125291 | Miesel et al. | Sep 2000 | A |
6126611 | Bourgeouis et al. | Oct 2000 | A |
6132384 | Christopherson et al. | Oct 2000 | A |
6134459 | Roberts et al. | Oct 2000 | A |
6144866 | Miesel et al. | Nov 2000 | A |
6175767 | Doyle, Sr. | Jan 2001 | B1 |
6181961 | Prass | Jan 2001 | B1 |
6198952 | Miesel | Mar 2001 | B1 |
6223064 | Lynn et al. | Apr 2001 | B1 |
6240316 | Richmond et al. | May 2001 | B1 |
6248080 | Miesel et al. | Jun 2001 | B1 |
6249703 | Stanton et al. | Jun 2001 | B1 |
6251126 | Ottenhoff et al. | Jun 2001 | B1 |
6269269 | Ottenhoff et al. | Jul 2001 | B1 |
6307481 | Lehrman et al. | Oct 2001 | B1 |
6309350 | Van Tassel et al. | Oct 2001 | B1 |
6314324 | Lattner et al. | Nov 2001 | B1 |
6342039 | Lynn et al. | Jan 2002 | B1 |
6345202 | Richmond et al. | Feb 2002 | B2 |
6361494 | Lindenthaler | Mar 2002 | B1 |
6393325 | Mann et al. | May 2002 | B1 |
6449507 | Hill et al. | Sep 2002 | B1 |
6450957 | Yoshimi et al. | Sep 2002 | B1 |
6456866 | Tyler et al. | Sep 2002 | B1 |
6509164 | Guirguis | Jan 2003 | B1 |
6522928 | Whitehurst et al. | Feb 2003 | B2 |
6532388 | Hill et al. | Mar 2003 | B1 |
6572543 | Christopherson et al. | Jun 2003 | B1 |
6574507 | Bonnet | Jun 2003 | B1 |
6587725 | Durand et al. | Jul 2003 | B1 |
6609016 | Lynn | Aug 2003 | B1 |
6609032 | Woods et al. | Aug 2003 | B1 |
6629527 | Estes et al. | Oct 2003 | B1 |
6641542 | Cho et al. | Nov 2003 | B2 |
6645143 | Van Tassel et al. | Nov 2003 | B2 |
6647289 | Prutchi | Nov 2003 | B2 |
6651652 | Ward | Nov 2003 | B1 |
6654634 | Prass | Nov 2003 | B1 |
6665560 | Becker et al. | Dec 2003 | B2 |
6666830 | Lehrman et al. | Dec 2003 | B1 |
6689068 | Hale et al. | Feb 2004 | B2 |
6703939 | Lehrman et al. | Mar 2004 | B2 |
6718208 | Hill et al. | Apr 2004 | B2 |
6719708 | Jansen | Apr 2004 | B1 |
6731976 | Penn et al. | May 2004 | B2 |
6731984 | Cho et al. | May 2004 | B2 |
6735471 | Hill et al. | May 2004 | B2 |
6752765 | Jensen et al. | Jun 2004 | B1 |
6770022 | Mechlenburg et al. | Aug 2004 | B2 |
6773404 | Poezevera et al. | Aug 2004 | B2 |
6805667 | Christopherson et al. | Oct 2004 | B2 |
6811538 | Westbrook et al. | Nov 2004 | B2 |
6842647 | Griffith et al. | Jan 2005 | B1 |
6881192 | Park | Apr 2005 | B1 |
6890306 | Poezevera | May 2005 | B2 |
6893405 | Kumar et al. | May 2005 | B2 |
6904320 | Park et al. | Jun 2005 | B2 |
6907293 | Grill et al. | Jun 2005 | B2 |
6928324 | Park et al. | Aug 2005 | B2 |
6935335 | Lehrman et al. | Aug 2005 | B1 |
6936011 | Sheldon | Aug 2005 | B2 |
6964641 | Cho et al. | Nov 2005 | B2 |
6978171 | Goetz et al. | Dec 2005 | B2 |
6988498 | Berthon-Jones et al. | Jan 2006 | B2 |
7025730 | Cho et al. | Apr 2006 | B2 |
7041049 | Raniere | May 2006 | B1 |
7054692 | Whitehurst et al. | May 2006 | B1 |
7077810 | Lange et al. | Jul 2006 | B2 |
7081095 | Lynn et al. | Jul 2006 | B2 |
7082331 | Park et al. | Jul 2006 | B1 |
7082336 | Ransbury et al. | Jul 2006 | B2 |
7087053 | Vanney | Aug 2006 | B2 |
7117036 | Florio | Oct 2006 | B2 |
7128717 | Thach et al. | Oct 2006 | B1 |
7145461 | Lehrman et al. | Dec 2006 | B2 |
7149573 | Wang | Dec 2006 | B2 |
7155278 | King et al. | Dec 2006 | B2 |
7160252 | Cho et al. | Jan 2007 | B2 |
7160255 | Saadat | Jan 2007 | B2 |
7167743 | Heruth et al. | Jan 2007 | B2 |
7174215 | Bradley | Feb 2007 | B2 |
7186220 | Stahmann et al. | Mar 2007 | B2 |
7187978 | Malek et al. | Mar 2007 | B2 |
7189204 | Ni et al. | Mar 2007 | B2 |
7195594 | Eigler et al. | Mar 2007 | B2 |
7200440 | Kim et al. | Apr 2007 | B2 |
7206635 | Cho et al. | Apr 2007 | B2 |
7212862 | Park et al. | May 2007 | B2 |
7214197 | Prass | May 2007 | B2 |
7252640 | Ni et al. | Aug 2007 | B2 |
7269457 | Shafer et al. | Sep 2007 | B2 |
7269459 | Koh | Sep 2007 | B1 |
7277749 | Gordon et al. | Oct 2007 | B2 |
7330760 | Heruth et al. | Feb 2008 | B2 |
7336996 | Hartley et al. | Feb 2008 | B2 |
7340302 | Falkenberg | Mar 2008 | B1 |
7351208 | Brodnick et al. | Apr 2008 | B2 |
7366572 | Heruth et al. | Apr 2008 | B2 |
7371220 | Koh et al. | May 2008 | B1 |
7387608 | Dunlop et al. | Jun 2008 | B2 |
7395113 | Heruth et al. | Jul 2008 | B2 |
7396333 | Stahmann et al. | Jul 2008 | B2 |
7398115 | Lynn | Jul 2008 | B2 |
7422015 | Delisle et al. | Sep 2008 | B2 |
7438686 | Cho et al. | Oct 2008 | B2 |
7447545 | Heruth et al. | Nov 2008 | B2 |
7454250 | Bjorling et al. | Nov 2008 | B1 |
7453928 | Lee et al. | Dec 2008 | B2 |
7468040 | Hartley et al. | Dec 2008 | B2 |
7469697 | Lee et al. | Dec 2008 | B2 |
7473227 | Hsu et al. | Jan 2009 | B2 |
7491181 | Heruth et al. | Feb 2009 | B2 |
7510531 | Lee et al. | Mar 2009 | B2 |
7526341 | Goetz et al. | Apr 2009 | B2 |
7542803 | Heruth et al. | Jun 2009 | B2 |
7572225 | Stahmann et al. | Aug 2009 | B2 |
7590455 | Heruth et al. | Sep 2009 | B2 |
7591265 | Lee et al. | Sep 2009 | B2 |
7596413 | Libbus et al. | Sep 2009 | B2 |
7603170 | Hatlestad et al. | Oct 2009 | B2 |
7610094 | Stahmann et al. | Oct 2009 | B2 |
7634315 | Cholette | Dec 2009 | B2 |
7644714 | Atkinson et al. | Jan 2010 | B2 |
7662105 | Hatlestad | Feb 2010 | B2 |
7672728 | Libbus et al. | Mar 2010 | B2 |
7678061 | Lee et al. | Mar 2010 | B2 |
7680538 | Durand et al. | Mar 2010 | B2 |
7702385 | Moffitt et al. | Apr 2010 | B2 |
7717848 | Heruth et al. | May 2010 | B2 |
7720541 | Stahmann et al. | May 2010 | B2 |
7725195 | Lima et al. | May 2010 | B2 |
7734340 | De Ridder | Jun 2010 | B2 |
7734350 | Dubnov et al. | Jun 2010 | B2 |
7742819 | Moffitt | Jun 2010 | B2 |
7747323 | Libbus et al. | Jun 2010 | B2 |
7751880 | Cholette | Jul 2010 | B1 |
7775993 | Heruth et al. | Aug 2010 | B2 |
7783353 | Libbus et al. | Aug 2010 | B2 |
7792583 | Miesel et al. | Sep 2010 | B2 |
7809442 | Bolea et al. | Oct 2010 | B2 |
7818063 | Wallace et al. | Oct 2010 | B2 |
7853322 | Bourget et al. | Dec 2010 | B2 |
7881798 | Miesel et al. | Feb 2011 | B2 |
7908013 | Miesel et al. | Mar 2011 | B2 |
7917230 | Bly | Mar 2011 | B2 |
7942822 | Koh | May 2011 | B1 |
7957797 | Bourget et al. | Jun 2011 | B2 |
7957809 | Bourget et al. | Jun 2011 | B2 |
7979128 | Tehrani et al. | Jul 2011 | B2 |
8016776 | Bourget et al. | Sep 2011 | B2 |
8021299 | Miesel et al. | Sep 2011 | B2 |
8150531 | Skelton | Apr 2012 | B2 |
8160711 | Tehrani et al. | Apr 2012 | B2 |
8175720 | Skelton et al. | May 2012 | B2 |
8280513 | Tehrani | Oct 2012 | B2 |
20010010010 | Richmond et al. | Jul 2001 | A1 |
20020010495 | Freed et al. | Jan 2002 | A1 |
20020049479 | Pitts | Apr 2002 | A1 |
20020156507 | Lindenthaler | Oct 2002 | A1 |
20030093128 | Freed et al. | May 2003 | A1 |
20030114905 | Kuzma | Jun 2003 | A1 |
20030224895 | Gordon et al. | Jun 2003 | A1 |
20030163059 | Poezevera et al. | Aug 2003 | A1 |
20030195571 | Burnes et al. | Oct 2003 | A1 |
20030216789 | Deem et al. | Nov 2003 | A1 |
20040015204 | Whitehurst et al. | Jan 2004 | A1 |
20040073272 | Knudson et al. | Apr 2004 | A1 |
20040111139 | McCreery | Jun 2004 | A1 |
20040215288 | Lee et al. | Oct 2004 | A1 |
20040230278 | Dahl et al. | Nov 2004 | A1 |
20040254612 | Ezra | Dec 2004 | A1 |
20050004628 | Goetz et al. | Jan 2005 | A1 |
20050010265 | Baru Fassio et al. | Jan 2005 | A1 |
20050042589 | Hatlestad et al. | Feb 2005 | A1 |
20050043765 | Williams et al. | Feb 2005 | A1 |
20050043772 | Stahmann et al. | Feb 2005 | A1 |
20050074741 | Lee et al. | Apr 2005 | A1 |
20050076908 | Lee et al. | Apr 2005 | A1 |
20050080348 | Stahmann et al. | Apr 2005 | A1 |
20050080461 | Stahmann et al. | Apr 2005 | A1 |
20050081847 | Lee et al. | Apr 2005 | A1 |
20050085865 | Tehrani | Apr 2005 | A1 |
20050085866 | Tehrani | Apr 2005 | A1 |
20050085868 | Tehrani et al. | Apr 2005 | A1 |
20050085869 | Tehrani et al. | Apr 2005 | A1 |
20050085874 | Davis et al. | Apr 2005 | A1 |
20050101833 | Hsu et al. | May 2005 | A1 |
20050113710 | Stahmann et al. | May 2005 | A1 |
20050115561 | Stahmann et al. | Jun 2005 | A1 |
20050145246 | Hartley et al. | Jul 2005 | A1 |
20050165457 | Benser et al. | Jul 2005 | A1 |
20050182457 | Thrope et al. | Aug 2005 | A1 |
20050209513 | Heruth et al. | Sep 2005 | A1 |
20050209643 | Heruth et al. | Sep 2005 | A1 |
20050222503 | Dunlop et al. | Oct 2005 | A1 |
20050234523 | Levin et al. | Oct 2005 | A1 |
20050251216 | Hill et al. | Nov 2005 | A1 |
20050261747 | Schuler et al. | Nov 2005 | A1 |
20050267380 | Poezevera | Dec 2005 | A1 |
20050277844 | Strother et al. | Dec 2005 | A1 |
20050277999 | Strother et al. | Dec 2005 | A1 |
20050278000 | Strother et al. | Dec 2005 | A1 |
20060052836 | Kim et al. | Mar 2006 | A1 |
20060058852 | Koh et al. | Mar 2006 | A1 |
20060064029 | Arad (Abboud) | Mar 2006 | A1 |
20060079802 | Jensen et al. | Apr 2006 | A1 |
20060095088 | De Ridder | May 2006 | A1 |
20060103407 | Kakizawa et al. | May 2006 | A1 |
20060135886 | Lippert et al. | Jun 2006 | A1 |
20060155341 | Tehrani | Jul 2006 | A1 |
20060142815 | Tehrani et al. | Sep 2006 | A1 |
20060212096 | Stevenson | Sep 2006 | A1 |
20060224209 | Meyer | Oct 2006 | A1 |
20060241708 | Boute | Oct 2006 | A1 |
20060247729 | Tehrani et al. | Nov 2006 | A1 |
20060259079 | King | Nov 2006 | A1 |
20060264777 | Drew | Nov 2006 | A1 |
20060266369 | Atkinson et al. | Nov 2006 | A1 |
20060271137 | Stanton-Hicks | Nov 2006 | A1 |
20060276701 | Ray | Dec 2006 | A1 |
20060293720 | DiLorenzo | Dec 2006 | A1 |
20060293723 | Whitehurst et al. | Dec 2006 | A1 |
20070021785 | Inman et al. | Jan 2007 | A1 |
20070027482 | Parnis et al. | Feb 2007 | A1 |
20070038265 | Tcheng et al. | Feb 2007 | A1 |
20070150022 | Ujhazy et al. | Jun 2007 | A1 |
20070233204 | Lima et al. | Oct 2007 | A1 |
20070255379 | Williams et al. | Nov 2007 | A1 |
20080009685 | Kim et al. | Jan 2008 | A1 |
20080039904 | Bulkes et al. | Feb 2008 | A1 |
20080046055 | Durand et al. | Feb 2008 | A1 |
20080064977 | Kelleher et al. | Mar 2008 | A1 |
20080103545 | Bolea et al. | May 2008 | A1 |
20080103570 | Gerber | May 2008 | A1 |
20080109046 | Lima et al. | May 2008 | A1 |
20080109048 | Moffitt | May 2008 | A1 |
20080132802 | Ni et al. | Jun 2008 | A1 |
20080294060 | Haro et al. | Nov 2008 | A1 |
20090024047 | Shipley et al. | Jan 2009 | A1 |
20090062882 | Zhang et al. | Mar 2009 | A1 |
20090112116 | Lee et al. | Apr 2009 | A1 |
20090118787 | Moffitt et al. | May 2009 | A1 |
20090234427 | Chinn et al. | Sep 2009 | A1 |
20090287279 | Parramon et al. | Nov 2009 | A1 |
20090308395 | Lee et al. | Dec 2009 | A1 |
20090326408 | Moon | Dec 2009 | A1 |
20100010566 | Thacker et al. | Jan 2010 | A1 |
20100016749 | Atsma et al. | Jan 2010 | A1 |
20100094379 | Meadows | Apr 2010 | A1 |
20100125310 | Wilson et al. | May 2010 | A1 |
20100125314 | Bradley et al. | May 2010 | A1 |
20100125315 | Parramon et al. | May 2010 | A1 |
20100137931 | Hopper et al. | Jun 2010 | A1 |
20100152553 | Ujhazy et al. | Jun 2010 | A1 |
20100174341 | Bolea et al. | Jul 2010 | A1 |
20100198103 | Meadows et al. | Aug 2010 | A1 |
20100198289 | Kameli | Aug 2010 | A1 |
20100228133 | Averina et al. | Sep 2010 | A1 |
20100228310 | Shuros et al. | Sep 2010 | A1 |
20100228317 | Libbus et al. | Sep 2010 | A1 |
20100241195 | Meadows et al. | Sep 2010 | A1 |
20100262210 | Parramon et al. | Oct 2010 | A1 |
20110093036 | Mashiach | Apr 2011 | A1 |
20110112601 | Meadows et al. | May 2011 | A1 |
20110152706 | Christopherson et al. | Jun 2011 | A1 |
20110152965 | Mashiach et al. | Jun 2011 | A1 |
20110160794 | Bolea et al. | Jun 2011 | A1 |
20110172733 | Lima | Jul 2011 | A1 |
20110264164 | Christopherson et al. | Oct 2011 | A1 |
Number | Date | Country |
---|---|---|
H11514557 | Dec 1992 | JP |
2010502276 | Jan 2010 | JP |
2011520526 | Jul 2011 | JP |
199750049 | Dec 1997 | WO |
2006047264 | May 2006 | WO |
2006057734 | Jun 2006 | WO |
2006102591 | Sep 2006 | WO |
2007068284 | Jun 2007 | WO |
2008048471 | Apr 2008 | WO |
2009048580 | Apr 2009 | WO |
2009048581 | Apr 2009 | WO |
2009135138 | Nov 2009 | WO |
2009135140 | Nov 2009 | WO |
2009140636 | Nov 2009 | WO |
2010039853 | Apr 2010 | WO |
2010057286 | May 2010 | WO |
2010059839 | May 2010 | WO |
2010117810 | Oct 2010 | WO |
Entry |
---|
Eisele Article—David W. Eisele, MD et al., “Tongue neuromuscular and direct hypoglossal nerve stimulation for obstructive sleep apnea,” Otolaryngologic Clinics of North America, Otolayngol Clin N Am 36 (2003) 501-510 (10 pages). |
Goodall Article—Eleanor V. Goodhall et al., “Position-Selective Activation of Peripheral Nerve Fibers with a Cuff Electrode,” IEEE Transaction on Biomedical Engineering, vol. 43, No. 8, Aug. 1996, pp. 851-856. |
Naples Article—Gregory G. Naples et al., “A Spiral Nerve Cuff Electrode for Peripheral Nerve Stimulation,” 8088 IEEE Transactions on Biomedical Engineering, 35. Nov. 1988, No. 11, New York, NY, pp. 905-915. |
Oliven Article—Arie Oliven et al., “Upper airway response to electrical stimulation of the genioglossus in obstructive sleep apnea,” Journal of Applied Physiology, vol. 95, pp. 2023-2029, Nov. 2003, www.jap.physiology.org on Sep. 18, 2006. (8 pages). |
Schwartz Article—Alan R. Schwartz MD et al., Theraputic Electrical Stimulation of the Hypoglossal Nerve in Obstructive Sleep Apnea, Arch Otolaryngol HeadAnd Neck Surg., vol. 127, Oct. 2001, pp. 1216-1223. Copyright 2001 American Medical Association. (8 pages). |
Park, “Preoperative Percutaneous Cranial Nerve Mapping in Head and Neck Surgery,” Arch Facial Plast Surg/vol. 5, Jan./Feb. 2003, www.archfacial.compp. 86-91. |
Stanescu et al., “Expiratory flow limitation during sleep in heavy snorers”, European Respiratory Journal, 1996, pp. 2116-2121. |
Number | Date | Country | |
---|---|---|---|
20190009093 A1 | Jan 2019 | US | |
20200030609 A9 | Jan 2020 | US |
Number | Date | Country | |
---|---|---|---|
61522426 | Aug 2011 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14238359 | US | |
Child | 15866164 | US |