THERAPEUTIC ULTRASOUND FOR EYE DISORDER
Methods and devices are described which allow sound waves to be safely be applied to the eyelid of an eye of a patient or through the eyelid to other structures in the eye or to or through structures in the facial region to effect changes to one or more structures in and around the eye or directly through the cornea or sclera to regions of the eye to treat one or more diseases of the eye.
1 . A method for stimulating tear production in a patient, said method comprising:
(a) positioning a vibratory surface at a bony region on the patient's face communicating with a parasympathetic nerve which innervates the lacrimal gland; and
(b) vibrating the vibratory surface at a frequency and a displacement selected to stimulate the lacrimal nerve to produce tears.
2 . The method of claim 1 wherein the vibratory surface is vibrated a frequency in a range from 10 Hz to 1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200 Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz, 50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200 Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300 Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000.
3 . The method of claim 2 , wherein the vibratory surface is vibrated with a displacement in a range from 0.1 mm to 5 mm, 0.25 mm to 5 mm, 0.5 mm to 5 mm, 1 mm to 5 mm, 0.1 mm to 3 mm, 0.25 mm to 3 mm, 0.5 mm to 3 mm, 1 mm to 3 mm, 0.1 mm to 5 mm, 0.25 mm to 2 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, or 2 mm to 3 mm.
4 . The method of claim 3 , wherein the vibratory surface has a skin contact area in a range from 0.5 mm 2 to 20 mm 2 , 0.5 mm 2 to 10 mm 2 , 0.5 mm 2 to 5 mm 2 , 0.5 mm 2 to 2 mm 2 , 0.5 mm 2 to 1.5 mm 2 , 0.5 mm 2 to 1 mm 2 , 1 mm 2 to 20 mm 2 , 1 mm 2 to 10 mm 2 , 1 mm 2 to 5 mm 2 , 1 mm 2 to 2 mm 2 , 1 mm 2 to 1.5 mm 2 , 1.5 mm 2 to 20 mm 2 , 0.5 mm 2 to 10 mm 2 , 1.5 mm to 5 mm, 1.5 mm 2 to 2 mm, 2 mm 2 to 20 mm, 2 mm to 10 mm, 2 mm 2 to 5 mm 2 , 2.5 mm 2 to 20 mm Z , 2.5 mm to 10 mm, 2.5 mm 2 to 5 mm, 5 mm 2 to 20 mm, or 5 mm to 10 mm 2 .
5 . The method of claim 4 , wherein the vibratory surface has a hardness in a range from Shore A40 to Shore A80, Shore A50 to Shore A80, Shore A60 to Shore A80, Shore A70 to Shore A80, Shore A40 to Shore A70, Shore A50 to Shore A70, Shore A60 to Shore A70, Shore A40 to Shore A60, Shore A50 to Shore A60, or Shore A40 to Shore A50.
6 . The method of claim 5 , wherein the vibratory surface is formed on a polymeric interface body.
7 . The method of claim 6 , wherein polymeric interface body has a thickness in a range from 1 mm to 10 mm, 2 mm to 10 mm, 3 mm to 10 mm, 4 mm to 01 mm, 5 mm to 10 mm, 6 mm to 10 mm, 7 mm to 10 mm, 8 mm to 10 mm, 9 mm to 10 mm, 1 mm to 5 mm, 2 mm to 5 mm, 3 mm to 5 mm, 4 mm to 5 mm, 1 mm to 4 mm, 2 mm to 4 mm, 3 mm to 4 mm, 1 mm to 3 mm, 2 mm to 3 mm, or 1 mm to 2 mm.
8 . The method of claim 7 , wherein the polymeric interface body has a rounded edge circumscribing at least a portion of the vibratory surface.
9 . The method of claim 8 , wherein the rounded edge has a radius in a range from 0.5 mm to 5 mm, 1 mm to 5 mm, 2 mm to 5 mm, 3 mm to 5 mm, 4 mm to 5 mm, 0.5 mm to 4 mm, 1 mm to 4 mm, 2 mm to 4 mm, 3 mm to 4 mm, 0.5 mm to 3 mm, 1 mm to 3 mm, 2 mm to 3 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, and 0.5 mm to 1 mm.
10 . The method of claim 7 , wherein the polymeric interface body has a square edge circumscribing at least a portion of the vibratory surface.
11 . The method of claim 1 , wherein the polymeric interface body has a rigid edge circumscribing at least a portion of the vibratory surface.
12 . The method of claim 1 , wherein the vibratory surface is vibrated with a pulsed duty cycle or 90%, 75%, 50%, 25% or 10%.
13 . The method of claim 1 , further comprising increasing a peak displacement of the vibratory surface when the duty cycle is less than 100%.
14 . The method of claim 1 , wherein the vibratory surface is positioned on the patient's face at a location where the patient's upper lateral nasal cartilage meets the patient's nasal bone.
15 . The method of claim 14 , wherein the vibratory surface is engaged against the patient's face with an upward directionality.
16 . The method of claim 1 , wherein the vibratory surface is positioned at a location from 6.5 mm to 8.5 mm lateral to the patient's nasal midline at the region.
17 . The method of claim 1 , wherein the parasympathetic nerve which innervates the lacrimal gland travels within the maxillary bone and then through the sphenopalatine ganglia is located close to the maxillary bone in the sphenopalatine fossa.
18 . The method of claim 1 , wherein positioning a vibratory surface comprises engaging a vibratory surface on a hand held device against the bony region.
19 . The method of claim 1 , wherein the patient engages the vibratory surface of the hand held device against the bony region.
20 . The method of claim 1 , wherein the vibratory surface moves in a substantially linear direction in one dimension.
21 . The method of claim 1 , wherein the vibratory surface moves in a substantially linear direction with an excursion of 1 to 2 mm.
22 . The method of claim 1 , wherein the vibratory surface is placed in a position to stimulate the external nasal nerve.
23 . A handheld device for stimulating tear production in a patient, said device comprising:
a housing having a vibratory surface configured to engage a bony region on the patient's face over an afferent nerve which communicates with a parasympathetic nerve which innervates glands related to the tear film; and
circuitry within the housing configured to vibrate the vibratory surface at a frequency and a displacement selected to stimulate the afferent nerve and the lacrimal nerve to produce tears.
24 . The hand held device of claim 23 , wherein the vibratory surface is vibrated a frequency in a range from 10 Hz to 1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200 Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz, 50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200 Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300 Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000.
25 . The hand held device of claim 23 , wherein the vibratory surface is vibrated with a displacement in a range from 0.1 mm to 5 mm, 0.25 mm to 5 mm, 0.5 mm to 5 mm, 1 mm to 5 mm, 0.1 mm to 3 mm, 0.25 mm to 3 mm, 0.5 mm to 3 mm, 1 mm to 3 mm, 0.1 mm to 5 mm, 0.25 mm to 2 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, or 2 mm to 3 mm.
26 . The hand held device of claim 23 , wherein the vibratory surface has a skin contact area in a range from 0.5 mm 2 to 20 mm 2 , 0.5 mm 2 to 10 mm 2 , 0.5 mm 2 to 5 mm 2 , 0.5 mm 2 to 2 mm 2 , 0.5 mm 2 to 1.5 mm 2 , 0.5 mm 2 to 1 mm 2 , 1 mm 2 to 20 mm 2 , 1 mm 2 to 10 mm, 1 mm 2 to 5 mm, 1 mm 2 to 2 mm 2 , 1 mm 2 to 1.5 mm 2 , 1.5 mm 2 to 20 mm 2 , 0.5 mm to 10 mm 2 , 1.5 mm 2 to 5 mm, 1.5 mm 2 to 2 mm 2 , 2 mm 2 to 20 mm, 2 mm to 10 mm, 2 mm 2 to 5 mm, 2.5 mm 2 to 20 mm, 2.5 mm to 10 mm, 2.5 mm 2 to 5 mm 2 , 5 mm 2 to 20 mm, or 5 mm 2 to 10 mm 2 .
27 . The hand held device of claim 23 , wherein the vibratory surface has a hardness in a range from Shore A40 to Shore A80, Shore A50 to Shore A80, Shore A60 to Shore A80, Shore A70 to Shore A80, Shore A40 to Shore A70, Shore A50 to Shore A70, Shore A60 to Shore A70, Shore A40 to Shore A60, Shore A50 to Shore A60, or Shore A40 to Shore A50.
28 . The hand held device of claim 23 , wherein the vibratory surface is configured to be positioned on the patient's face at a location where the patient's upper lateral nasal cartilage meets the patient's nasal bone.
29 . The hand held device of claim 23 , wherein the vibratory surface is configured to be engaged against the patient's face with an upward directionality.
30 . The hand held device of claim 32 , wherein the vibratory surface is configured to be positioned at a location from 6.5 mm to 8.5 mm lateral to the patient's nasal midline at the region. The hand held device of claim 23 , wherein the vibratory surface is formed on a polymeric interface body.
31 . The hand held device of claim 28 , wherein polymeric interface body has a thickness in a range from 1 mm to 10 mm, 2 mm to 10 mm, 3 mm to 10 mm, 4 mm to 01 mm, 5 mm to 10 mm, 6 mm to 10 mm, 7 mm to 10 mm, 8 mm to 10 mm, 9 mm to 10 mm, 1 mm to 5 mm, 2 mm to 5 mm, 3 mm to 5 mm, 4 mm to 5 mm, 1 mm to 4 mm, 2 mm to 4 mm, 3 mm to 4 mm, 1 mm to 3 mm, 2 mm to 3 mm, or 1 mm to 2 mm.
32 . The hand held device of claim 29 , wherein the polymeric interface body has a rounded edge circumscribing at least a portion of the vibratory surface.
33 . The hand held device of claim 30 , wherein the rounded edge has a radius in a range from 0.5 mm to 5 mm, 1 mm to 5 mm, 2 mm to 5 mm, 3 mm to 5 mm, 4 mm to 5 mm, 0.5 mm to 4 mm, 1 mm to 4 mm, 2 mm to 4 mm, 3 mm to 4 mm, 0.5 mm to 3 mm, 1 mm to 3 mm, 2 mm to 3 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, and 0.5 mm to 1 mm.
34 . The hand held device of claim 29 , wherein the polymeric interface body has a square edge circumscribing at least a portion of the vibratory surface.
35 . The hand held device of claim 28 , wherein the polymeric interface body has a rigid edge circumscribing at least a portion of the vibratory surface.
36 . The hand held device of claim 23 , wherein the circuitry is configured to vibrate vibratory surface with a pulsed duty cycle or 90%, 75%, 50%, 25% or 10%.
37 . The hand held device of claim 34 , wherein the circuitry is configured to increase a peak displacement of the vibratory surface when the duty cycle is less than 100%.
38 . The hand held device of claim 34 , wherein the vibratory surface vibrates in a substantially linear, single dimension substantially perpendicular to the skin.
39 . The hand held device of claim 23 , wherein the hand held device is configured to be positioned by the patient so that the vibratory surface engages the vibratory surface against the bony region.
40 . The hand held device of claim 32 , wherein the circuitry is configured to allow adjustment of the vibrational frequency.
41 . The hand held device of claim 40 , wherein the hand held device includes a manual frequency adjustment interface.
42 . A method for stimulating tear production in a patient, said method comprising:
(a) retracting an eyelid; and
(b) engaging a vibratory surface against the retracted eyelid at a frequency and a displacement selected to stimulate tear production.
43 . The method of claim 42 , further comprising compressing the retracted eyelid between a retractor and a compression member.
44 . The method of claim 42 , wherein engaging a vibratory surface against the retracted eyelid comprises energizing at least one transducer on at least one of the retractor and the compression member.
45 . The method of claim 44 , wherein the at least one transducer is an ultrasound transducer operating at a frequency in a range from 20 kHz to 30 MHz or from 3 MHz and 10 MHz.
46 . The method of claim 45 , wherein the ultrasound vibration penetrates the eyelid and heats a tissue plane inside the lid such that a surface of the eyelid remains substantially at body temperature (38° C. to 40° C.) while the inner eyelid is heated to from 42° C. to 48° C.).
47 . The method of claim 44 , wherein the at least one transducer operates at a frequency in a range from 10 Hz to 1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200 Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz, 50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200 Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300 Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000.
48 . A hand held device for stimulating tear production in a patient, said device comprising:
a retractor having a eyelid-engaging end and a handle end;
a vibrational transducer on the eyelid-engaging end of the retractor and configured to deliver vibrational energy into the eyelid when the eyelid is engaged by the eyelid-engaging end of the retractor.
49 . The hand held device of claim 48 , comprising at least one ultrasonic vibrational transducer.
50 . The hand held device of claim 49 , the ultrasound transducer operates at a frequency in a range from 20 kHz to 30 MHz or from 3 MHz and 10 MHz.
51 . The hand held device of claim 48 , comprising at least one non-ultrasonic vibrational transducer.
52 . The hand held device of claim 48 , wherein the non-ultrasound transducer operates at a frequency in a range from 10 Hz to 1000 Hz, 10 Hz to 500 Hz, 10 Hz to 400 Hz, 10 Hz to 300 Hz, 10 Hz to 200 Hz, 10 Hz to 100 Hz, 10 Hz to 50 Hz, 50 Hz to 1000 Hz, 50 Hz to 500 Hz, 50 Hz to 400 Hz, 50 Hz to 300 Hz, 50 Hz to 200 Hz, 50 Hz to 100 Hz, 200 Hz to 1000 Hz, 200 Hz to 500 Hz, 200 Hz to 400 Hz, 200 Hz to 300 Hz, 300 Hz to 1000 Hz, 300 Hz to 500 Hz, 300 Hz to 400 Hz, or 400 Hz to 1000.
53 . The hand held device of 48 , comprising at least one ultrasonic vibrational transducer and at least one non-ultrasonic vibrational transducer.
54 . The hand held device of 48 , further comprising circuitry configured to drive the at least one transducer.
55 . A method for stimulating tear production in a patient, said method comprising:
(a) retracting an eyelid; and
(b) engaging a vibratory surface against the retracted eyelid at a frequency and a displacement selected to open Meibomian glands in the patient.
56 . The method of claim 55 , further comprising measuring the temperature of the eyelid.
57 . The method of claim 55 , further comprising compressing the eyelid while the vibratory surface is applied.
58 . The method of claim 55 , further comprising placing the vibratory surface against the inner portion of the eyelid.
59 . The method of claim 55 , further comprising placing the vibratory surface against the outer part of the eyelid.
60 . A hand held device for stimulating tear production in a patient, said device comprising:
a retractor having an eyelid-engaging end and a handle end;
a pushrod having a distal member, wherein the pushrod is configured to slide on the handle end to capture a patient's eyelid between the retractor and the distal member;
a vibrational transducer on the eyelid-engaging end of the retractor and configured to deliver vibrational energy into the eyelid when the eyelid captured between the retractor and the distal member.
61 . The hand held device of claim 60 , wherein the pushrod is spring-biased to open and manually advanced to close over the eyelid.
62 . The hand held device of claim 61 , further comprising a force gauge to indicate a force being applied to the eyelid.
63 . The hand held device of claim 60 , wherein the vibrational transducer generates ultrasound at frequencies from 20 KHz to 30 MHz to heat the eyelid to disrupt inspissation in blocked ducts.
64 . The hand held device of claim 60 , wherein the vibrational transducer generates ultrasound at frequencies from 500 kHz and 3 MHz to heat the eyelid to disrupt inspissation in blocked ducts.
65 . The hand held device of claim 60 , further comprising a control system to maintain a temperature between 40° C. and 47° C.