The present disclosure relates generally to an implantable stimulation system for stimulating and monitoring soft tissue in a patient, and more particularly, the present disclosure relates to a lead system for positioning an electrode and lead body of an implantable stimulation system within a body.
Sleep apnea generally refers to the cessation of breathing during sleep. One type of sleep apnea, referred to as obstructive sleep apnea (OSA), is characterized by repetitive pauses in breathing during sleep due to the obstruction and/or collapse of the upper airway, and is usually accompanied by a reduction in blood oxygenation saturation.
One treatment for obstructive sleep apnea has included the delivery of electrical stimulation to the hypoglossal nerve, located in the neck region under the chin. Such stimulation therapy activates the upper airway muscles to maintain upper airway patency. In treatment of sleep apnea, increased respiratory effort resulting from the difficulty in breathing through an obstructed airway is avoided by synchronized stimulation of an upper airway muscle or muscle group that holds the airway open during the inspiratory phase of breathing. For example, the genioglossus muscle is stimulated during treatment of sleep apnea by a cuff electrode place around the hypoglossal nerve.
Because of the significant amount of movement in multiple directions that can take place under the chin, positioning an electrode to enable stimulation of the hypoglossal nerve becomes a significant challenge. On the one hand, placement of the electrode and lead in close proximity to the hypoglossal nerve can result in irritation to the nerve as a result of normal motion of the chin and neck, while on the other hand, without close adherence to the nerve, buildup of connective tissue between the nerve and the electrode cuff and lead can occur, causing low thresholds, thereby reducing the effectiveness of the delivered stimulation by the device. Similarly, a related challenge in maintaining the proper positioning of the electrode includes making a proper placement of a lead body that extends from the electrode to an implantable pulse generator, which is typically located in the pectoral region of the patient.
Aspects and features of the present invention will be appreciated as the same becomes better understood by reference to the following detailed description of the embodiments of the present disclosure when considered in connection with the accompanying drawings, wherein:
The following detailed description is merely exemplary in nature and is not intended to limit the present disclosure or the application and uses of the embodiments of the present disclosure. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
Embodiments of the present disclosure provide a lead system including a cuff electrode configured to be secured on a nerve and a lead body extending from the cuff electrode to connect with an implantable pulse generator located remotely from the location of the nerve. In one embodiment, the lead body includes a first lead portion, an anchor, and a second lead portion. The anchor is secured relative to a non-nerve anatomical structure, such as a tendon, in close proximity to the location of the cuff electrode on the nerve. In one aspect, the first lead body is configured with a length substantially greater than a distance between the secured cuff electrode and the secured anchor. In another aspect, the first lead portion includes a generally serpentine configuration formed of a resilient material.
With this arrangement, a strain relief mechanism is established to prevent the cuff electrode from being dislodged from the nerve, or from placing undue stress on the nerve, on the cuff electrode, and/or on the lead body. By securing the anchor to a non-nerve anatomical structure near the secured cuff electrode and by providing a relatively long first lead portion with a generally serpentine configuration, the lead system provides a generous length of the first lead portion between the anchor and the cuff electrode, thereby ensuring that little, if any, strain is exerted on the lead body, on the cuff electrode, and/or on the nerve.
These embodiments, and other embodiments, will be described in association with
The sensor 60 may be a pressure sensor that is surgically implanted in a region that has pressure continuity with the intrapleural space, such as the suprasternal notch, the space between the trachea and esophagus, or by being attached to either of the trachea or esophagus. The sensor 60 may also be positioned intercostally, or secured in a position for sensing pressure at the posterior side of the manubrium. The suprasternal notch 62 and manubrium 63 of the sternum 64 are well known structures on the upper chest that are in anatomical continuity with the intrapleural space. It is also well known that changes in intrapleural pressure provide a characteristic respiratory effort waveform.
The location for placement of the sensor 60 is, at least in part, chosen as a function of a delay, i.e. the propagation time associated with a pressure waveform characteristic of respiratory effort propagating from the respiratory point of origin to the sensor position. The chosen location is also a function of the amount of filtering necessary to achieve a usable sensed signal at a particular location, i.e. the amount of filtering that is necessary to remove waveforms other than the waveform associated with the desired sensed characteristic, such as the filtering required to remove cardiac waveform activity, for example. The positioning of the sensor 60 enables the IPG 55 to receive respiratory effort waveform information utilized to determine increased respiratory effort, which is then used by the IPG 55 to control delivery of therapy in response to determined increases in respiratory effort.
In one embodiment, the array 102 of electrodes 103 are embedded within a wall of the cuff body 101 with the respective electrodes 103 spaced apart from each other along a length of the cuff body 101. In some embodiments, the electrodes 103 are aligned in series along a single longitudinal axis on a common side or portion of the cuff body 101.
In some embodiments, cuff 100 additionally includes an outer flap or flange member that is biased and configured to maintain releasable coverage of at least a portion of an outer surface of the cuff body 101 and of the re-closable opening 109 between the distal ends of fingers 134, 150, as will be described in more detail in association with at least
As illustrated in
In some embodiments, the first flange member 130 includes a proximal end 131 and a distal end or portion 132 with the proximal end 131 being bonded to the third flange member 150 along a portion of an outer wall 152 of the third flange member 150. The first flange member 130 has a length sufficient to extend about, and be in releasable contact with, the periphery or outer surface of both the third flange member 150 and a majority of a length of the second flange member 134. In this arrangement, with the first flange member 130 extending coextensively with (and in releasable contact with) a majority of the arcuate length of the second flange member 134, the first flange member 130 is biased to maintain coverage across the substantially re-closable opening 109 (between the distal ends 136, 152 of the respective second and third flange members 134, 150).
In one aspect, the free distal portion (including distal end 132) of the first flange member 130 extends in a first direction or orientation opposite to the direction (or orientation) in which the free distal portion (including distal end 136) of the second flange member 134 extends. In this arrangement, with the first flange member 130 and the second flange member 134 being biased in an overlapping, releasably contacting relationship, each of the distal ends 132, 136 of the respective first and second flange members 130, 134 will move in opposite directions upon expansion of the lumen 140 in response to a swollen nerve or during positioning of the cuff 100 about a nerve, as will be further described in association with at least
During its normal, unbiased state, prior to insertion around the nerve, the electrode cuff 100 is in a fully engaged position (shown in
Depending on the size of the nerve about which the cuff 100 is mounted, the electrode cuff 100 may be either in the fully engaged position of
In one aspect, the first lead portion 204 extends proximally from the cuff electrode 202 and is formed of a resilient material to have a pre-formed, generally serpentine configuration. In another aspect, the second lead portion 208 also is formed of a resilient material to have a pre-formed, generally serpentine configuration. However, the second lead portion 208 has a length substantially greater than a length of the first lead portion 204. For example, in one non-limiting example, the second lead portion 208 has a length about seven times the length of the first lead portion 204. In this arrangement, the second lead portion 208 has a length sufficient to extend from the placement location of the cuff electrode 202 at a target nerve (e.g. hypoglossal nerve) to the location of placement of the IPG 55 (
In one embodiment, the generally serpentine configuration of the respective first and second lead portions 204, 208 comprises a generally sinusoidal pattern including a series of S-shaped curves. However, in other embodiments, the generally serpentine configuration of the respective first and second lead portions 204, 208 comprises other undulating or curvaceous shapes and patterns. In some embodiment, a respective one of the first and second lead portions 204, 208 has a first type of undulating or curvaceous pattern while the other respective one of the first and second lead portions 204, 208 have a second, different type of undulating or curvaceous pattern.
In one aspect, the anchor 206 is interposed between the first lead portion and the second lead portion 208 and is configured to be secured relative to a body structure adjacent to the target nerve on which the cuff electrode 202 is mounted. The connector 210 extends proximally from the second lead portion 208 and is configured to electrically connect to an implantable pulse generator (such as IPG 55 in
However, in some embodiments, the lead system 200 additionally includes a second anchor interposed between the second lead portion 208 and the connector 210 at a location represented by reference numeral 220 (or another location closer to the first anchor 204). This second anchor is configured to be secured relative to a body structure and is provided to provide strain relief for the lead system relative to the IPG 55 and relative to the first anchor 204 (when it is secured in close proximity to the cuff electrode and nerve).
In some embodiments, method 300 includes arranging the secured cuff electrode 202 and the secured anchor 206 in substantially the same vertical plane such that a majority of the first lead portion 204 extends generally perpendicular to the vertical plane. In one aspect, this arrangement helps to provide the strain relief described below in more detail.
The second lead portion 208 is then maneuvered and arranged to extend proximally from the anchor toward an implantable pulse generator, using tunneling tools as known in the art. Finally, the connector is used to establish electrical communication and mechanical connection to the IPG 55.
In this arrangement, by securing the anchor 206 onto a non-nerve anatomical structure 330 in close proximity to the location at which the cuff electrode 202 is secured onto the target nerve 310, a substantial length or portion 341 of the first lead portion 204 remains in a serpentine or otherwise undulating configuration to thereby provide strain relief upon relative movement of the nerve 310 and the tendon 330. In other words, upon movement of the cuff electrode 202 as the nerve 310 moves, only minimal strain or no strain is placed on the lead portion 204, on the cuff electrode 202, and/or on the nerve 310 because of the position of the nearby anchor 206 and because of the combination of the sufficient length and generally serpentine configuration of the first lead portion 204 (which ensures that a substantial room for movement is allowable for the cuff electrode 202).
In one embodiment, as illustrated in
In some embodiments, as illustrated in
It is understood that at least some of these actions of method 300 need not be performed in a particular order.
Embodiments of the present disclosure ensure long term, robust deployment of a cuff electrode on a nerve via a lead system. In some embodiments, this robust engagement is accomplished via placing a relatively long, generally serpentine lead portion between the secured cuff electrode and an anchor secured to a non-nerve anatomical structure close to the cuff electrode and nerve.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the present disclosure in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the present disclosure as set forth in the appended claims and the legal equivalents thereof.
This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/049,927, filed on May 2, 2008, and incorporated herein by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2009/042546 | 5/1/2009 | WO | 00 | 3/4/2011 |
Number | Date | Country | |
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61049927 | May 2008 | US |