Source: http://www.google.es/patents/US20100198282
Timestamp: 2018-01-23 04:19:39
Document Index: 293463772

Matched Legal Cases: ['§120', '§ 120', '§120', '§119', 'Application No. 60', '§120', '§119', 'Application No. 60', 'Application No. 60', '§119', 'Application No. 61', 'Application No. 2003', 'Application No. 2003', 'Application No. 61']

Patente US20100198282 - Devices for vestibular or cranial nerve stimulation - Google Patentes
A nerve tissue stimulator configured for contacting to or insertion in the body of a subject to stimulate a tissue therein, said probe comprising: (a) a support configured for contacting to or positioning adjacent a tissue of said subject; (b) at least one thermoelectric device (TED) on said support...http://www.google.es/patents/US20100198282?utm_source=gb-gplus-sharePatente US20100198282 - Devices for vestibular or cranial nerve stimulation
Número de publicación US20100198282 A1
Número de solicitud US 12/704,872
También publicado como US8696724, US20140249608
Número de publicación 12704872, 704872, US 2010/0198282 A1, US 2010/198282 A1, US 20100198282 A1, US 20100198282A1, US 2010198282 A1, US 2010198282A1, US-A1-20100198282, US-A1-2010198282, US2010/0198282A1, US2010/198282A1, US20100198282 A1, US20100198282A1, US2010198282 A1, US2010198282A1
Inventores Lesco L. Rogers
Cesionario original Rogers Lesco L
Citas de patentes (75), Citada por (42), Clasificaciones (9), Eventos legales (3)
US 20100198282 A1
1. A nerve tissue stimulator configured for contacting to or insertion in the body of a subject to stimulate a tissue therein, said probe comprising:
(a) a support configured for contacting to or positioning adjacent a tissue of said subject;
(b) at least one thermoelectric device (TED) on said support and positioned for thermally stimulating said nerve tissue.
2. The tissue stimulator of claim 1, wherein said at least one thermoelectric device comprises a plurality of thermoelectric devices, each of said plurality of thermoelectric devices positioned on said support for stimulating said tissue.
3. The tissue stimulator of claim 2, wherein said plurality of thermoelectric devices are positioned adjacent one another on said support at a density of at least 5 per square centimeter up to 400 per square centimeter.
4. The tissue stimulator of claim 2, wherein said plurality of thermoelectric devices are positioned adjacent one another in a linear array.
5. The tissue stimulator of claim 2, wherein said plurality of thermoelectric devices are positioned adjacent one another in a two-dimensional array.
6. The tissue stimulator of claim 2, wherein said plurality of thermoelectric devices are thermally coupled to one another.
7. The tissue stimulator of claim 1, each of said thermoelectric devices having an first side and a second side, said first side thermally coupled to a heat transfer structure and said second side positioned for thermally stimulating said tissue so that the thermoelectric device is thermally coupled between the heat transfer structure and said tissue.
8. The tissue stimulator of claim 1, wherein said stimulator is a probe having a distal end portion and an elongate body portion.
9. The tissue stimulator of claim 8, wherein at least one of said thermoelectric devices is located at said probe or catheter distal end portion, and wherein said elongate body portion is optionally insulated.
10. The tissue stimulator of claim 9, wherein said plurality of thermoelectric devices are positioned along said elongate body portion.
11. The stimulator of claim 2, wherein said stimulator is a cochlear stimulator configured to be inserted into the cochlea of a subject with said thermoelectric devices positioned to stimulate ganglion cell in the basal region of the cochlea.
12. The tissue stimulator of claim 1, further comprising at least one electrode on said probe for electrically stimulating said tissue.
13. The tissue stimulator of claim 1, wherein said at least one thermoelectric device comprises a thin film thermoelectric transducer.
14. The tissue stimulator of claim 2, further comprising a plurality of thermal stimulation conductive lines, each of said plurality of thermoelectric devices electrically coupled to at least one separate thermal stimulation conductive line.
15. The tissue stimulator of claim 2, further comprising a plurality of electrical stimulation conductive lines, each of said plurality of thermoelectric devices electrically coupled to at least one separate thermal stimulation conductive line.
16. The tissue stimulator of claim 15, said plurality of separate conductive lines bundled together in a single lead, said lead having a terminal connector configured for connection to a controller.
17. The tissue stimulator of claim 1, wherein said stimulator comprises a pair of stimulators connected to a head piece, said head piece configured for positioning said pair of stimulators in both ears of a subject, with one stimulator in each ear.
18. The tissue stimulator of claim 17, further comprising a heat sink thermally coupled to said at least one thermoelectric device and extending into said head piece.
19. The tissue stimulator of claim 17, wherein said head piece comprises a flexible or adjustable, over-the-head or behind-the-head, band.
20. The tissue stimulator of claim 17, wherein said head piece comprises a flexible or adjustable under-the-chin connecting piece.
(a) a tissue stimulator of claim 1; and
(b) a controller electrically coupled to the thermoelectric device, wherein the controller is configured to sense a first value of an electrical characteristic of the thermoelectric device, to generate a first electrical control signal to pump heat through the thermoelectric device in response to sensing the first value of the electrical characteristic of the thermoelectric device, to sense a second value of the electrical characteristic of the thermoelectric device wherein the first and second values of the electrical characteristic are different, and to generate a second electrical control signal to pump heat through the thermoelectric device in response to sensing the second electrical characteristic of the thermoelectric device, wherein the first and second electrical control signals are different.
22. A temperature control system according to claim 21 wherein the controller is configured to sense the first and second electrical characteristics by sensing electrical signals generated by the thermoelectric device responsive to first and second heat gradients across the thermoelectric device.
23. A temperature control system according to claim 21 wherein the controller is configured to generate the first electrical control signal so that heat is pumped through the thermoelectric device in a first direction, and to generate the second electrical control signal so that heat is pumped through the thermoelectric device in a second direction opposite the first direction.
24. A temperature control system according to claim 23 wherein the controller is configured to generate the first electrical control signal so that a first electrical current flows through the thermoelectric device in a first direction, and to generate the second electrical control signal so that a second electrical current flows through the thermoelectric device in a second direction opposite the first direction.
25. The tissue stimulator of claim 1, further comprising a controller operatively associated with said at least one thermoelectric device for adjusting said at least one thermoelectric device.
26. The tissue stimulator of claim 25, further comprising a subject or patient parameter sensor operatively associated with said controller, and with said controller configured so that said thermoelectric device is responsive to the detection of a subject or patient parameter.
27. The tissue stimulator of claim 26, wherein said subject or patient parameter sensor is selected from the group consisting of position sensors, motion detectors, blood pressure sensors, heart rate sensors, blood gas level sensors, electrocardiogram (ECG) sensors, electroencephalogram (EEG) sensors, electrooculogram (EOG) sensors, electronystagmography sensors, breath-rate sensors, nystagmus sensors, galvanic skin response (GSR) sensors, tympanic membrane temperature sensors, brain temperature sensors, and tissue temperature sensors.
28. The tissue stimulator of claim 27, wherein said patient parameter sensor is a position sensor; and wherein controller is configured to selectively adjust said thermoelectric device when a predetermined patient position is detected.
29. The tissue stimulator of claim 27, wherein said patient parameter sensor is a local tissue temperature sensor, and wherein said controller is configured to selectively adjust said thermoelectric device when a predetermined local tissue temperature is detected.
30. The tissue stimulator of claim 1, further comprising:
a heat sink operatively associated with said at least one thermoelectric device; and
a temperature sensor operatively associated with both said heat sink and said controller;
said controller configured to selectively activate or inactivate said at least one thermoelectric device when a predetermined temperature for said heat sink is detected.
31. The tissue stimulator of claim 1, further comprising a current steering controller operatively associated with said at least one thermoelectric device (TED).
32. The tissue stimulator of claim 28, wherein said current steering controller comprises a pulse generator responsive to programming signals for generating stimulation currents; a system responsive to the programming signals for selectively applying the stimulation currents to one or more TEDs; and a current steering unit responsive to directional signals configured for steering the stimulation currents from at least one first TED to at least one second TED.
33. A tissue stimulator configured for contacting to or insertion in the body of a subject to stimulate a tissue therein, said probe comprising:
(b) at least one thermoelectric device (TED) on said support and positioned for thermally stimulating said tissue;
wherein said support is configured as an ear insert so dimensioned as to be insertable into the ear canal of a wearer.
34. The tissue stimulator of claim 33, wherein said at least one thermoelectric device comprises a plurality of thermoelectric devices, each of said plurality of thermoelectric devices positioned on said support for stimulating said tissue.
35. The tissue stimulator of claim 34, wherein said plurality of thermoelectric devices are positioned adjacent one another on said support at a density of at least 5 per square centimeter up to 400 per square centimeter.
36. The tissue stimulator of claim 34, wherein said plurality of thermoelectric devices are positioned adjacent one another in a linear array.
37. The tissue stimulator of claim 34, wherein said plurality of thermoelectric devices are positioned adjacent one another in a two-dimensional array.
38. The tissue stimulator of claim 34, wherein said plurality of thermoelectric devices are thermally coupled to one another.
39. The tissue stimulator of claim 33, each of said thermoelectric devices having an first side and a second side, said first side thermally coupled to a heat transfer structure and said second side positioned for thermally stimulating said tissue so that the thermoelectric device is thermally coupled between the heat transfer structure and said tissue.
40. The tissue stimulator of claim 33, wherein said stimulator is a probe having a distal end portion and an elongate body portion.
41. The tissue stimulator of claim 40, wherein at least one of said thermoelectric devices is located at said probe or catheter distal end portion, and wherein said elongate body portion is optionally insulated.
42. The tissue stimulator of claim 41, wherein said plurality of thermoelectric devices are positioned along said elongate body portion.
43. The stimulator of claim 34, wherein said stimulator is a cochlear stimulator configured to be inserted into the cochlea of a subject with said thermoelectric devices positioned to stimulate ganglion cell in the basal region of the cochlea.
44. The tissue stimulator of claim 33, further comprising at least one electrode on said probe for electrically stimulating said tissue.
45. The tissue stimulator of claim 33, wherein said at least one thermoelectric device comprises a thin film thermoelectric transducer.
46. The tissue stimulator of claim 34, further comprising a plurality of thermal stimulation conductive lines, each of said plurality of thermoelectric devices electrically coupled to at least one separate thermal stimulation conductive line.
47. The tissue stimulator of claim 34, further comprising a plurality of electrical stimulation conductive lines, each of said plurality of thermoelectric devices electrically coupled to at least one separate thermal stimulation conductive line.
48. The tissue stimulator of claim 47, said plurality of separate conductive lines bundled together in a single lead, said lead having a terminal connector configured for connection to a controller.
49. The tissue stimulator of claim 33, wherein said stimulator comprises a pair of stimulators connected to a head piece, said head piece configured for positioning said pair of stimulators in both ears of a subject, with one stimulator in each ear.
50. The tissue stimulator of claim 49, further comprising a heat sink thermally coupled to said at least one thermoelectric device and extending into said head piece.
51. The tissue stimulator of claim 49, wherein said head piece comprises a flexible or adjustable, over-the-head or behind-the-head, band.
52. The tissue stimulator of claim 49, wherein said head piece comprises a flexible or adjustable under-the-chin connecting piece.
(a) a tissue stimulator of claim 33; and
54. A temperature control system according to claim 53 wherein the controller is configured to sense the first and second electrical characteristics by sensing electrical signals generated by the thermoelectric device responsive to first and second heat gradients across the thermoelectric device.
55. A temperature control system according to claim 53 wherein the controller is configured to generate the first electrical control signal so that heat is pumped through the thermoelectric device in a first direction, and to generate the second electrical control signal so that heat is pumped through the thermoelectric device in a second direction opposite the first direction.
56. A temperature control system according to claim 53 wherein the controller is configured to generate the first electrical control signal so that a first electrical current flows through the thermoelectric device in a first direction, and to generate the second electrical control signal so that a second electrical current flows through the thermoelectric device in a second direction opposite the first direction.
57. The tissue stimulator of claim 56, further comprising a controller operatively associated with said at least one thermoelectric device for adjusting said at least one thermoelectric device.
58. The tissue stimulator of claim 56, further comprising a subject or patient parameter sensor operatively associated with said controller, and with said controller configured so that said thermoelectric device is responsive to the detection of a subject or patient parameter.
59. The tissue stimulator of claim 58, wherein said subject or patient parameter sensor is selected from the group consisting of position sensors, motion detectors, blood pressure sensors, heart rate sensors, blood gas level sensors, electrocardiogram (ECG) sensors, electroencephalogram (EEG) sensors, electrooculogram (EOG) sensors, electronystagmography sensors, breath-rate sensors, nystagmus sensors, galvanic skin response (GSR) sensors, tympanic membrane temperature sensors, brain temperature sensors, and tissue temperature sensors.
60. The tissue stimulator of claim 59, wherein said patient parameter sensor is a position sensor; and wherein controller is configured to selectively adjust said thermoelectric device when a predetermined patient position is detected.
61. The tissue stimulator of claim 59, wherein said patient parameter sensor is a local tissue temperature sensor, and wherein said controller is configured to selectively adjust said thermoelectric device when a predetermined local tissue temperature is detected.
62. The tissue stimulator of claim 33, further comprising:
63. The tissue stimulator of claim 33, further comprising a current steering controller operatively associated with said at least one thermoelectric device (TED).
64. The tissue stimulator of claim 63, wherein said current steering controller comprises a pulse generator responsive to programming signals for generating stimulation currents; a system responsive to the programming signals for selectively applying the stimulation currents to one or more TEDs; and a current steering unit responsive to directional signals configured for steering the stimulation currents from at least one first TED to at least one second TED.
This application claims priority under 35 U.S.C. §120 to, and is a continuation-in-part of, U.S. patent application Ser. No. 12/699,374, filed Feb. 3, 2010 (attorney docket number 9767-2ip), the disclosure of which is incorporated herein by reference in its entirety.
This application also claims priority under 35 U.S.C. § 120 to, and is a continuation-in-part of U.S. patent application Ser. No. 12/669,684, filed Jan. 19, 2010 (attorney docket number 9767-2), which itself claims priority under 35 U.S.C. §120 to PCT Application No. PCT/US2008/071935, filed Aug. 1, 2008, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/953,700, filed Aug. 3, 2007, the disclosure of each of which is incorporated herein by reference in its entirety.
This application also claims priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 12/693,016, filed Jan. 25, 2010 (attorney docket number 9767-311P2), which is itself a continuation-in-part of U.S. patent application Ser. No. 12/166,953, filed Jul. 2, 2008, which is itself a continuation-in-part of U.S. patent application Ser. No. 11/972,267, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/884,546, filed Jan. 11, 2007, and of U.S. Provisional Application No. 60/908,261, filed Mar. 27, 2007, the disclosure of each of which is incorporated herein by reference in its entirety.
This application also claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 61/224,668, filed Jul. 10, 2009 (attorney docket number 9767-13PR), the disclosure of which is incorporated herein by reference in its entirety.
Disorder/Symptom Treated Reference
Elusive sleep U.S. Pat. No. 6,748,275
Migraine headaches O. Kolev, Cephalalgia 10: 167 (1990)
Neurodegenerative disorders Y. Yamamoto et al., Ann Neurol. 58: 175 (2005)
Parkinson's Disease Y. Yamamoto et al., Ann Neurol. 58: 175 (2005)
Reduced respiratory function U.S. Pat. No. 6,748,275
Restricted airway U.S. Pat. No. 6,748,275
Seasickness/Travel sickness U.S. Patent Application No. 2003/0195588
Spatial- and verbal-memory D. Bachtold et al., Exp Brain Res 136: 128 (2001)
Thalamic pain syndrome V. Ramachandran et al. Neurocase, iFirst, 1-4 (2007)
Vertigo U.S. Pat. No. 6,748,275; U.S. Patent Application No. 2003/0195588
Brain areas activated by CVS and disorders/symptoms associated with each area
Brain stem hiccups, cranial nerve disorders, dizziness, facial weakness, nystagmus,
voice alterations, vertical gaze problems, blurred vision, dysarthria,
Cerbellum vertigo, nystagmus, tremor, slurred speech, movement disorders
Fusiform gyrus autism, faulty word/number recognition, faulty processing of color
Insula cortex addiction, Alzheimer's disease, Parkinson's disease, neurodegenerative
disorders, psychiatric disorders
Parietal lobe hemianesthesia, seizures, visual dysfunction, facial numbness, agraphia,
dysgraphia, alien limb syndrome, spatial neglect
Singular gyrus schizophrenia, ADHD, OCD, mutism, mood disorders
Supplementary motor cortex seizures, muscle weakness, spasticity
Temporal lobe epilepsy, anomia, aphasia, dysphasia, parosmia, anger control
Accordingly, apparatuses and associated methods useful for delivering stimulation to the nervous system and/or the vestibular system of an individual are potentially beneficial to take full advantage of physiological responses that are useful in diagnosing and/or treating_a variety of medical conditions.
The foregoing and other objects and aspects of the present invention are explained in greater detail in the drawings herein and the specification set forth below. All U.S. patent references cited herein are specifically intended to be incorporated herein by reference in their entirety.
Any suitable TED or transducer can be used to carry out the present invention, including, but not limited to, those described in U.S. Pat. Nos. 7,205,675; 7,098,393; 7,024,865; and 5,974,806; and in United States Patent Publication No. 2004/0199266. See also Riffat and Ma, Applied Thermal Engineering 23:913 (2003). The transducer can be an electrothermal textile transducer, including, but not limited to, those described in U.S. Pat. Nos. 7,202,443; 6,977,360; and 6,229,123. The transducer is typically provided with a lead which may be connected to an external power supply and controller, or the power supply and controller may be contained within the device as discussed further below. The devices disclosed herein further include embodiments of thermoelectric transducers in all shapes and sizes, including but not limited to spiral and helical shapes.
FIGS. 13-14 illustrate a further embodiment of the present invention, in which an external housing 50 is connected to the ear insert by a bridge member 51 (here, in the shape of a tube). The external housing 50 is configured for positioning behind the ear of a subject. The housing 50 can contain a computerized control module, control circuitry, a power supply such as a battery, controls such as an on-off switch 52, etc. In the illustrated embodiment the housing has an external transducer 53 mounted on the medial surface 54 thereof, which external transducer can deliver thermal, electric, or mechanical stimuli to the subject at sub-threshold (e.g. stochastic) or super-threshold levels, which stimuli may be given in any suitable pattern alone or in cooperation with stimuli from the ear canal transducers. Note that the external transducer can be positioned on the housing so that it contacts the subject on or adjacent to the mastoid process 25 of the subject.
FIG. 15 schematically illustrates a device of the present invention operatively associated with a controller 60, which controller is in turn operatively associated with a power supply 61. The controller and power supply can be contained within the device (e.g., in an external housing as described in connection with FIGS. 13-14 above), in a belt-worn or other housing, connected to a stationary unit such as a personal computer, or in any other suitable configuration. In a preferred embodiment, the controller includes a computerized control module 70 programmed with computer instructions (i.e., software) that controls the magnitude, duration, wave pattern, and other attributes of the vestibular stimulation.
As shown in FIG. 15, once the device is positioned within the ear canal 20 of a subject, the at least one thermoelectric transducer 30 a, 30 b, 30 c, each of which is operatively associated with the controller by a separate lead 31 a, 31 b, 31 c, is activated for a time and to a temperature sufficient to deliver CVS and/or cranial nerve stimulation to the subject. An adjustable or programmable control module 70 can be utilized to optimize stimulation for a particular subject, and for a particular purpose or condition. Where (as shown in FIG. 15) there are at least two separately controllable thermoelectric transducers on the ear insert inner portion spaced apart from one another, the activating step can comprise separately and selectively activating the at least two separately controllable thermoelectric transducers (e.g., by activating only one or two thereof, by heating one transducer and cooling another; by sequentially activating transducers; by activating different transducers to different degrees; combinations of some or all of the foregoing, etc.) Patterns of separate and selective activation can be preprogrammed, can be determined empirically, can be optimized by the subject or a programmer (such as a clinician) in a programming session with the subject, etc.
Subjects or subjects for the devices of the present invention are often, but are not limited to, human subjects, including both male and female subjects at any stage of development (e.g., juvenile, adolescent, adult, and geriatric subjects). While the shape of ears and ear canals 20 thus will vary among subjects, and different sizes and combinations of ear inserts and optional sleeves will likely be necessary to accommodate different subjects, an optimal set of inserts and optional sleeves can be developed through the use of statistical shape analysis (see, e.g., Paulsen, Statistical Shape Analysis of the Human Ear Canal with Application to In-the-Ear Hearing Aid Design (Kongens Lyngby 2004)) to provide ready availability of the devices of the present invention without the need to custom-mold a device for each individual subject, including, but not limited to, through the added adaptability between subjects contributed by the compressible optional sleeve 40 portion.
In some embodiments, an insert 11 of the invention is preformed to conform to, and hence conformably engage, the ear canal 20 of a particular subject. Such a preformed insert 11 can be produced by forming an ear impression, which ear impression can then be used for casting in analogous manner as described in U.S. Pat. No. 6,249,587, or can instead be scanned and utilized for subsequent casting; three-dimensional ink-jet printing, and/or other three dimensional construction (via deposition or removal of materials), as described in U.S. Pat. Nos. 7,162,323; and 6,986,739 (see also Fuller, J. Microelectromechanical Systems 11:54 (2002). With such a preformed device any possible need for a sleeve may be obviated, although it is preferred, but not required, that the ear insert itself comprise or be formed of a soft resilient material (e.g., having a hardness of from 0 to 50 on the Shore A scale).
A different embodiment of the vestibular and/or cranial nerve stimulating device 10 is shown in FIGS. 16 and 17. In this embodiment, which is in no way limiting of the invention, the device includes the ear insert 11, thermoelectric transducer 30, electrode 85, and computerized control module 70 described above. As shown in FIGS. 16 and 17, however, the active elements (30, 70, 85) on the insert 11, including any transducer 63 or electrode 64, occupy adjustable positions for greater control over the device 10. The ability to adjust the position of the active elements on the insert allows for greater flexibility in directing stimulation in a way that is customized for that person. Minor changes in the direction and location of output can have large consequences for different individuals. As shown in FIGS. 16 and 17, one embodiment of the device includes modular portions 60-62 that fit together and come apart for greater variety in positioning the output. The modular structure shown in FIGS. 16 and 17 also allows for interchangeable ear inserts to be used with a single control module housed in the outer portion of the device.
Interchangeable ear inserts 62 are useful to allow for a variety of modifications in keeping with the scope of this invention. For example, a single individual might require diagnosis or therapy with fewer or greater numbers of any active element. As noted herein, the device 10 includes the flexibility to increase or reduce the number of electrodes 64, transducers 63, or other active elements necessary to achieve a desired result. Also, the modular nature of the device shown in FIGS. 16 and 17 allows for portions or pieces of the device 10 to be replaced without replacing the whole device. An ear insert 62 might be less expensive to replace than the computerized control module. Accordingly, FIGS. 16 and 17 illustrate schematically one embodiment of a modular vestibular stimulation device in which the active elements, located on either the ear insert 11 portion, or possibly a sleeve 40 as described above, are attached to an outer portion 50 via standard electrical connectors.
FIG. 18 also shows a modification to previously described embodiments by which the head set assembly 100 includes an extensive heat sink capacity in the form of head band heat sink portion 97 extending along one side of the head band 96. The heat sink portion 97 terminates on either end at thermoelectric transducers 95A-D installed on the ear inserts 92A, 92B. As the thermoelectric transducers remove heat from the inner ear or surrounding tissue, the heat sink portion 97 removes the excess heat from the transducers 95A-D via heat sink extensions 99A-D associated with each respective transducer 95A-D. The heat sink extensions 99A-D are independently connected to the head band heat sink portion 97, which has more than sufficient capacity to transfer heat from the transducers 95A-D to the atmosphere.
The head set assembly 100 also accommodates multiple variations of control systems used in accordance with this invention. As shown in FIG. 18, each insert 92A, 92B may optionally be connected to power and control circuitry in respective external housings 90A, 90B.
The external housing 90A, 90B can contain a computerized control module, control circuitry, a power supply such as a battery, controls such as on-off switches, etc. The external housing 90A, 90B, therefore, may include all of the electronics necessary for programming and controlling a course of therapy on either side of the subject's head, all the while assisting in disposing of excess heat via the heat sink structures 97, 99.
In certain circumstances, the head set assembly 100 is most effective if both inserts 92A, 92B have the capacity for communicating with a common control system. FIG. 19 shows this control system included in universal control enclosure 101 located at the top of the head band 96. The head set assembly 100 incorporates a communications link 98 that extends across the head band to the external housings 90A, 90B to coordinate the stimulation given by respective thermoelectric transducers 95A-D. In other embodiments, the universal control enclosure 101 may include sufficient power circuitry and controllers to reduce or eliminate the need for the external housings 90A, 90B. For optimal utility and comfort, however, the subject may prefer certain components, such as batteries, to be worn in the external enclosures positioned behind the ear or elsewhere.
Overall, the embodiment of FIG. 18 allows multiple thermoelectric transducers 95A-95D to be controlled via control circuitry to provide heating, cooling, and/or electrical stimulation to nerve endings in the ear as well as the vestibular system. The heat energy is regulated by the conveniently positioned heat sink portion 97 on the head band 96.
The vestibular system and/or cranial nerve stimulation device 10 may be operational as an individualized piece of equipment worn by a single user, similar to the way a person wears a hearing aid. In different embodiments, however, the device 10 can be incorporated into a larger medical system. In one embodiment, the computerized control module 70 connects to peripheral equipment for added functionality. In a preferred embodiment, the device 10 is part of a larger therapeutic system that includes other devices for monitoring physiological parameters. Without limiting the types of peripheral equipment connecting to the device described herein, one useful peripheral sensor measures galvanic skin resistance. Skin resistance is a significant factor in estimating certain physiological and emotional changes that an individual is experiencing. When data tracking skin resistance are combined with data tracking a circadian cycle, such as the temperature cycle, the result is a broader, more holistic approach to treating an individual. Skin resistance also provides information regarding changes and phase shifts to the circadian cycle and is therefore useful as a feedback check on the effectiveness of any currently administered vestibular stimulation. Accordingly, in one aspect, the device 10, particularly the computerized control module 70, processes data gathered by peripheral devices, such as a galvanic skin resistance, and adjusts device 10 output accordingly. In line with this galvanic skin resistance model, the device is useful for practicing a method of delivering vestibular stimulation and/or cranial nerve stimulation to an individual's brain. In one embodiment, the method includes (i) arranging a thermal transducer 30 and an electrode 85 on an ear insert 11 in a position to stimulate the vestibular system and/or at least one cranial nerve of the subject, (ii) electronically connecting the transducer 30 and the electrode 85 to a controller 38, and (iii) supplying the controller 38 with galvanic skin resistance data and temperature data from the individual. Next, the device 10 activates the transducer 30 and the electrode 85 via the controller 38. The transducer regulates heat exchange within the ear canal for a time and to a temperature sufficient to deliver vestibular stimulation to the individual. Similarly, the electrode 85 provides electrical stimulation to the vestibular system according to pre-set functions within the controller 38. In combination, the controller 38, the transducer 30, and the electrode 85 deliver vestibular stimulation, wherein the vestibular stimulation is selected from caloric stimulation, electrical stimulation, and combinations of each. The method further includes the step of measuring physiological changes in the individual, wherein the physiological changes are selected from the group consisting of brain temperature changes, brain chemistry changes and blood chemistry changes. The step of measuring physiological changes can be selected from the group consisting of circadian temperature cycle time shifts, ascorbic acid production, serotonin production, histamine production, vasopressin production, acetylcholine production, and/or heat shock protein production. Brain temperature should probably be included since it reflects the metabolic state of activated/inactivated tissues
The devices disclosed herein incorporate standard features that are commonly used in hearing aids and other inner ear devices known today. For instance, given the fact that vestibular stimulation will likely not be administered around the clock, the device incorporates an automatic shutdown mode enabled during extensive periods of inactivity. Other useful features available for the device include battery operation and padding for the outer portion worn on the outer ear. The housing 50 for the computerized control module 70 may be available in stylized and appropriately colored models to accommodate the tastes of the individual wearing it.
Further examples of stimulators of the present invention are schematically illustrated in FIGS. 1 and 2 of United States Provisional Application No. 61/224,668, the disclosure of which is incorporated herein by reference in its entirety.
In some embodiments, where multiple TEDs are included on the probe, the device can include a power steering capability for adjusting the power, signal, and/or timing of signal to particular TEDs on the probe. This is advantageous when, for example, the probe includes multiple TEDs thermally coupled to one another, and one or more TEDs are used to apply heat to tissue, and one or more TEDs are concurrently used to cool tissue, so that displaced heat is offset at least in part from one device to another. Current steering can be implemented in accordance with known techniques or variations thereof that will be apparent to those skilled in the art. See, e.g., U.S. Pat. No. 6,909,917, the disclosure of which is incorporated by reference herein in its entirety. Such a current steering unit or controller can include a pulse generator responsive to programming signals for generating stimulation currents; a system responsive to the programming signals for selectively applying the stimulation currents to one or more TEDs; and/or a current steering unit responsive to directional signals configured for steering the stimulation currents from the at least one first TED to at least one second TED. The current steering unit may optionally be configured to redistribute currents from the TEDs in a manner that is perceived as a smooth redistribution. The redistributing unit may optionally include a formula-based algorithm means for redistributing stimulation current from one of the electrodes included within the array of devices to another of the electrodes included within the array of devices. Preferably, the redistribution unit includes programming or an alogorithm to compare power or current routed to TEDs that are heating tissue and TEDs in thermal contact therewith that are cooling tissue, so that heat transfer can be at least partially offset therebetween.
In some embodiments the sensor is mounted on or connected to the probe for example, as can be the case of a tissue temperature sensor.
In some embodiments, the sensor is mounted in a separate housing as can be the case for a motion detector.
FIGS. 21-22 schematically illustrate stimulators 150 of the present invention operatively associated with a controller 160, which controller is in turn operatively associated with a power supply 161. The controller and power supply can be contained within the device (e.g., in an external housing as described in connection with FIGS. 13-14 above), in a belt-worn or other housing, connected to a stationary unit such as a personal computer, or in any other suitable configuration. In some embodiments the stimulator may comprise a heat-sink 151 formed of a thermally conductive material such as aluminum, and may include an additional element of thermally insulating material (e.g., an organic polymer material) 152 connected thereto for carrying a sensor such as a tissue or patient temperature sensor 153. Additional sensors such as a heart rate sensor 183 or patient position sensor 182 can be included as desired depending upon the particular configuration of the device and purpose for which the device is being used. For example, the optimum patient position for administering CVS is a reclining position of about 30 degrees, and a position sensor can be included to automatically activate the thermoelectric devices once such a position is achieved.
Exemplary stimulation patterns for apparatuses incorporating
multiple TEDs
TEC #1 TEC #2 TEC #3
10. Stochastic-heat Heat waveforms
(sinusoidal, square
sawtooth)
14. Delivery of electrical stimulus
across cultured neuronal tissues
A first aspect of the invention is a method of treating a disorder in a subject in need thereof, comprising (i) positioning a thermoelectric device (“TED”) in the ear canal of a subject and (ii) activating the TED sufficient to treat the disorder. Activating the thermoelectric device may comprise stimulating the vestibular system and/or at least one cranial nerve effective to treat the disorder. The disorder may include, but is not limited to, migraine headaches, asthma, Parkinson's disease, epilepsy, stroke, cellular ischemia, excitotoxic brain injury, traumatic brain injury, spinal cord injury, sensory disorders, motor disorders, and cognitive disorders.
TNM Device: A device of the present invention can be provided with a thermal monitor in a single or both ears. Each hemisphere is activated sequentially through a specific task or through CVS, with concurrent measurement of ear canal temperature change from the baseline state. The drop in ear canal temperature reflects hemispheric activation. A larger differential indicates a greater likelihood that a disorder is causing excess cortical activity on one side of the brain. Using depression as an example: Depression can have associated right hemisphere preponderance. CVS activation of the right hemisphere via warming the right ear or cooling the left can result in a temperature decrease that is larger than the normal population would experience. It is also anticipated that such temperature decrease within the right hemisphere, and therefore the larger differential side-to-side, can be abnormally prolonged due to the hemispheric dysfunction.
STRENGTH OF NYSTAGMUS—CVS can also be used to diagnose hemispheric dysfunction by assessing the strength of response to stimulation through measurement of nystagmus. See, e.g., A. Soza Ried and M. Aviles, Neuroscience 144, 128-134 (2007).
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Clasificación cooperativa A61N1/32, A61F2007/0296, A61F2007/0075, A61F7/12, A61F7/00, A61F7/007
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ROGERS, LESCO L.;REEL/FRAME:024254/0950