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Stimulation devices and methods for treating dry eye

A dry eye syndrome and stimulator technology, applied in the field of devices for treating dry eye syndrome or eye fatigue, can solve problems such as providing adequate treatment for no symptoms

Inactive Publication Date: 2017-08-29
OCULEVE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] While a wide range of DED treatments exist, these treatments do not provide adequate treatment for the condition

Method used

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  • Stimulation devices and methods for treating dry eye
  • Stimulation devices and methods for treating dry eye
  • Stimulation devices and methods for treating dry eye

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0188] Example 1: Stimulation using lacrimal implants

[0189] Patients with a microstimulator implanted in the ocular region were stimulated with 30 Hz non-patterned (control) and on / off patterns (1 s on / 1 s off, 2 s on / 2 sec off, and 5 sec on / 5 sec off) for testing. The implanted microstimulator has Figures 2A-2C features shown in and described herein.

[0190] Patient perception of stimuli differed between the 30 Hz non-patterned waveform control and the time-patterned waveform. Specifically, 3 patients who received the unpatterned waveform at 30 Hz felt their perception of the waveform fade out during the stimulation period, whereas when receiving the time-patterned waveform, no patient reported the perception of the waveform faded out during the stimulation period . When the stimulus was a 30 Hz, 1 s on / off waveform ("pattern 1"), 3 patients perceived the waveform as continuous and 15 patients perceived the waveform as intermittent. When the stimulus was a 30 Hz, 5 ...

Embodiment 2

[0195] Example 2: Stimulation using lacrimal implants (2)

[0196] Use of time-patterned waveforms compared to basal tearing (control 1 = no electrical stimulation) and to 30 Hz stimulation (non-patterned) (control 2) in patients with microstimulators implanted in the ocular region Compared to increased lacrimation as measured by the Schirmer test. The implanted microstimulator has Figures 2A-2C features shown in and described herein. Data are presented below in Table 2 and compare mean tearing results from basal tearing (left, no stimulation) with 30 Hz non-patterned waveform stimulation (middle) and time-patterned patient-optimized stimulation waveform (right) The bar graph for Figure 15 middle. Based on the data in Table 2, the mean value for basal tearing was 4.71 mm, the mean value for non-patterned stimulation at 30 Hz was 4.96 mm, and the mean value was 8.29 mm when temporally patterned stimulation was used. Overall, mean Schirmer scores were increased by about 5...

Embodiment 3

[0201] Example 3: Stimulation using lacrimal implants (3)

[0202] Nineteen patients had microstimulators implanted in the eye region. (Twelve of these patients were the same as in Example 2) For each patient, the patient-optimized time-patterned waveform was determined by adjusting the waveform frequency, pulse width, and on / off period, while collecting patient feedback in order to maximize Reported paresthesias in the orbital region, as described above.

[0203] Use the same controller / energizer for each patient to deliver each waveform. The waveforms tested for each patient included:

[0204] -30Hz

[0205] -30Hz, 1 second on, 1 second off

[0206] -30Hz, 5 seconds on, 5 seconds off

[0207] -70Hz, 1 second on, 1 second off

[0208] -30Hz, pulse width modulated from 100% to 0%, and modulated back to 100% within 1 second

[0209] -30Hz, pulse width modulated from 100% to 70%, and modulated back to 100% within 1 second

[0210] -70Hz, pulse width modulated from 100% t...

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Abstract

Described herein are devices and methods of use thereof for treating dry eye, tired eye, or other forms of ocular discomfort such as from contact lenses. The methods generally include applying spatially and / or temporally patterned stimulation to one or more anatomical structures located in an ocular or nasal region. The electrical stimulation may elicit a reflex that activates the lacrimal gland or may directly activate the lacrimal gland or nerves innervating the lacrimal gland to produce tears. The devices may be implantable or handheld, and may be configured to deliver the spatially and / or temporally patterned stimulation patterns described.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application No. 62 / 067,416, filed October 22, 2014 and titled "STIMULATION PATTERNS," the entire contents of which are incorporated herein by reference. technical field [0003] Devices and methods of use for treating dry eye or eye strain are described herein. The method generally includes applying a spatially and / or temporally patterned stimulus to one or more anatomical structures located in the ocular or nasal region. Electrical stimulation can cause a reflex that activates the lacrimal gland, or it can directly activate the lacrimal gland or the nerves innervating the lacrimal gland to produce tears. Background technique [0004] Dry eye disease ("DED") is a condition that affects millions of people worldwide. More than 40 million people in North America suffer from some form of dry eye, and millions more worldwide suffer from it. DED is caused by disrup...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61N1/36
CPCA61N1/3756A61N1/0526A61N1/0546A61N1/3606A61N1/36146A61N1/36046A61N1/37205A61N1/37247A61N1/3758A61N1/36128A61H39/00A61N1/04A61N1/36
Inventor M·弗兰克J·D·劳丁J·沃德尔M·J·霍尔德布鲁克
Owner OCULEVE
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