Stimulation For Treating Sleep Disordered Breathing
Patent No. US10898709 (titled "Stimulation For Treating Sleep Disordered Breathing") was filed by Inspire Medical Systems Inc on Mar 16, 2016.
What is this patent about?
’709 is related to the field of medical devices, specifically devices and methods for treating obstructive sleep apnea (OSA) . OSA is a condition characterized by repeated interruptions in breathing during sleep, often due to the collapse of soft tissues in the upper airway. Existing treatments include continuous positive airway pressure (CPAP) therapy, which can be uncomfortable and poorly tolerated, and surgical interventions, which carry inherent risks. Electrical stimulation of nerves controlling airway muscles, such as the hypoglossal nerve, has emerged as a promising alternative.
The underlying idea behind ’709 is to maintain upper airway patency by applying electrical stimulation to an airway-patency-related nerve, such as the hypoglossal nerve, using a stimulation protocol that is asynchronous with the patient's breathing pattern. This means the stimulation is delivered independently of real-time respiratory sensing, relying instead on a pre-programmed cycle of stimulation and non-stimulation periods. The key insight is that by carefully selecting the duration of these periods, the stimulation can effectively prevent airway collapse without requiring precise synchronization with each breath.
The claims of ’709 focus on a device for treating obstructive sleep apnea that includes a non-cardiac stimulation element designed to stimulate an upper-airway-patency-related nerve. The stimulation is delivered according to a first stimulation therapy protocol that is not synchronized with actively sensed respiratory information. This protocol involves a series of repeating stimulation cycles, each consisting of a stimulation period and a non-stimulation period. The stimulation period features continuous stimulation and has a minimum duration equal to or greater than an inspiratory reference derived from a reference respiratory cycle.
In practice, the device delivers a repeating cycle of electrical stimulation to the target nerve. The stimulation period is designed to be long enough to overlap with the inspiratory phase of a typical breath, even though the device isn't actively sensing the patient's breathing. The non-stimulation period allows the muscles to rest, preventing fatigue. The reference respiratory cycle, used to determine the inspiratory reference, can be either a historical average for the specific patient or a multi-patient average, providing flexibility in implementation.
This approach differs from prior solutions that rely on real-time respiratory sensing to trigger stimulation. By eliminating the need for synchronization, the device can be simpler, more reliable, and potentially less expensive. It also avoids issues that can arise when sensor signals become unstable or unavailable. The asynchronous stimulation ensures that the airway muscles are consistently activated to maintain patency, regardless of variations in the patient's breathing pattern.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’709 was filed, targeted electrical stimulation was being explored for various therapies, including alleviating obstructive sleep apnea by stimulating the hypoglossal nerve. At a time when systems commonly relied on sensing elements to trigger stimulation, alternative approaches were also being developed. Hardware or software constraints made it non-trivial to optimize stimulation protocols independently of real-time respiratory characteristics.
Novelty and Inventive Step
The examiner allowed the claims because they are directed to stimulating at a duration equal to or greater than an inspiratory reference of a reference respiratory cycle based on a historical patient-specific average or multi-patient average. The examiner stated that the prior art, specifically Tehrani, discloses a stimulation time greater than one inspiration cycle but does not specify a non-stimulation period less than the duration of a stimulation period and applies these stimulations to the hemidiaphragms which are not upper airway nerves.
Claims
There are 15 claims in total. Claim 1 is the only independent claim, and it focuses on a device for treating obstructive sleep apnea using a non-cardiac stimulation element that stimulates an upper-airway-patency-related nerve according to a specific stimulation protocol. The dependent claims elaborate on the features and functionalities of the device described in the independent claim, such as specific components, stimulation parameters, and control mechanisms.
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Date
Description
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US10898709
- Application Number
- US15562714
- Filing Date
- Mar 16, 2016
- Status
- Granted
- Expiry Date
- Mar 16, 2036
- External Links
- Slate, USPTO, Google Patents