IL111762A - Apparatus for treatment of migraine - Google Patents

Description

APPARATUS FOR TREATMENT OF MIGRAINE SHMUEL GONEN in i "?Nmuj AHARON YERUSHALMI -•n'pun-r ΙΠΠΝ C:19806 19806hea.sim HB-9411 24/11/94 FIELD OF THE INVENTION The present invention relates generally to apparatus and techniques for non-invasive treatment of migraine and headache .

BACKGROUND OF THE INVENTION Substantial efforts have been made over the years to cure or treat migraine and headaches. Various attempts have been made to establish a single mechanism for the cause of migraine.

The mechanism has been postulated to be, inter alia: a disorder of platelets (Hannington E, Jones RJ, Amess JA, achowicz B. Migraine: a platelet disorder. Lancet, ii 720-723, 1981), a cerebrovascular spasm (Wolff HG. Headache and other head pain, Oxford University Press, New York, 1963) and central dysnociception (Sicuteri F. Migraine, a central biochemical dysnociception, Headache, 16:145-149, 1986).

Generally, there are known two types of migraine: 1. migraine without aura, attacks of severe pulsating head pain, lasting up to 72 hours, associated with nausea and/or photo- or phono-phobia, and aggravated by physical activity; and 2. migraine with aura: a similar pain phase heralded by an aura, characterized by gradually spreading neurological symptoms taking the form of spreading paresthesias and numbness in a hemiform pattern.

Tension-type headache is characterized by mild to moderate pain occurring in episodes of variable duration or continuously.

Based on the facts that migraine pain is usually pulsating and is relieved by vasoactive drugs, and often by vascular compression it has been determined that migraine pain is vascular in origin. Regional cerebral blood flow is markedly reduced, indicating that primary vasoconstriction is involved. (See: Olesen J. Some clinical features of the acute migraine attack. An analysis of 760 patients. Headache, 18:268-211, 1978; Blau, JN, Dexter SL. The site of pain origin during migraine attacks. Cephalalgia 1: 143-147, 1981.; Drummond PD, Lance JW. Extracranial vascular changes and the source of pain in migraine headache. Ann. Neurol. 13 : 32- 37, 1983; Tunis MM, Wolff MG. Long term observations of the reactivity of the cranial arteries in subjects with vascular headache of the migraine headache of the type. Arch. Neurol. Psychiat. 70: 551-557, 1953; Wolff HG. Headache and other head pain, Oxford University Press, New York, 1963.

Migraine pain is known to be aggravated by physical activity and may be triggered or aggravated by vasoactive drugs. (See Iversen HK, Langemark M, Andersson PG, Hansen PE, Olesen J. Clinical characteristics of migraine and episodic tension type headache in relation to old and new diagnostic criteria. Headache, 30:514-519, 1990);Krabbe AE, Olesen J. Headache provocation by continuous intravenous infusion of histamine: clinical results and receptor mechanism. Pain, 8:253-259, 1980).

Regional cerebral blood flow changes have been detected during migraine with aura. These changes consist of a reduction in regional cerebral blood flow, beginning posteriorly and spreading anteriorly. The changes of regional cerebral blood flow during the course of classical migraine attacks. Ann. Neurol. 13:633-641, 1983). (See: Olesen J, Edvinsson L (eds.), Basic mechanisms of headache, Elsevier, Amsterdam pp 1-492, 1988 ) ; Lauritzen M, Skyhoj Olesen T, Lassen NA, Paulson OB).

In the area of reduced regional cerebral blood flow, vasoreactivity is impaired or abolished (Lauritzen M, Skyhoj Olsen T, Lassen NA, Paulson OB. The regulation of regional cerebral blood flow during and between migraine attacks. Ann. Neurol. 14:569-572, 1983). Regional cerebral blood flow is markedly reduced, indicating that primary vasoconstriction must be involved (Olsen TS, Friberg L, Lassen NA. Ischemia may be the primary cause of the neurologic deficits in classic migraine. Arch. Neurol. 44 : 258-161, 1987), and there is evidence of a stop-go flow pattern (Friberg L, Skyhoj Olsen T, Roland PE, Lassen NA. Cerebrovascular tone instability causing focal ischemia during attacks of hemiplegic migraine. Brain, 110: 917-934, 1987).

It has been reported that a posterior focal reduction in regional cerebral blood flow is observed first, followed by the symptoms of migrainous aura, which always precedes the headache .( See : Olesen J, Friberg L, Olsen TS, Iversen H , Lassen NA, Andersen AR, Karle A. Timing and topography of cerebral blood flow, aura and headache during migraine attacks. Ann. Neurol. 28 : 791-798, 1990) Support for vascular nociception is the marked tendency of patients suffering from migraine without aura to develop headache after histamine and nitroglycerine, drugs with a presumed vascular site of action. The pain and associated symptoms are identical in both forms of migraine, and both respond to the same drugs ( See: Sicuteri, F, Bene ED, Poggioni M, Bonnazzi A. Unmasking latent dysnociception in healthy subject. Headache 27: 180-186, 1987. Olesen J. Bonica JJ. Headache. In: Bonica (Ed), The management of pain, Lea and Febiger, Philadelphia, PA, 1990, pp. 687-726).

Marked tenderness of pericranial muscles during migraine attacks has been described. (See: Hay KM. Pain thresholds in migraine, Practitioner, 222:827-833, 1979). The muscles of migraine patients during attack-free periods are more tender than those of headache free individuals (See: Jensen K, Tuxen C, Olesen J. Pericranial muscle tenderness and pressure-pain threshold in the temporal region during common migraine. Pain, 35:65-70, 1988).

It has been found that in migraine, extracranial vascular compression relieves the pain in less than half the patients (See: Drummond PD, Lance JW. Extracranial vascular changes and the source of pain in migraine headache, Ann. Neurol. 13:32-37, 1983. Blau JN, Dexter SL. The site of pain origin during migraine attacks. Cephalalgia 1:143-147, 1981).

The trigeminal ganglion is the sensory nerve of the head, and its fibers are particularly important for head pain. (See: Moskowitz MA. The neurobiology of vascular head pain, Ann. Neurol. 16:157-168, 1984).

These fibers are projections from neurons mostly in the first division of the trigeminal ganglion and located in close proximity to, but discrete from, cells projecting to the forehead (See: O'Connor TP, Van der Kooy D. Pattern of intracranial and extracranial projections of trigeminal ganglion cells, J. Neurosci. 6 : 2200- 2207, 1986).

Some nociceptive specific neurons in the trigeminal nucleus caudalis receive input from nerve fibers around blood vessels via the trigeminal ganglion and also respond to stimulation of both intracranial and extracranial blood vessels. The above mentioned findings form the basis for our cranial programmed pulsating pressure (CPPP), treatment of cranial and forehead tissues.

US Patent Application No 5,245,989 discloses a system for applying rigidly controlled cranial pressure, comprising a substantially rigid cap or helmet having openings at predetermined locations, and pressure rods to extend from the openings for applying pressure to the scalp. 1 1 1,762/2 SUMMARY OF THE INVENTION The present invention seeks to provide apparatus and an improved technique for treatment of headache and migraine.

There is thus provided in accordance with a first aspect of the present invention apparatus for treatment of migraine or headache comprising a headset; a tissue conductivity sensor; and transducers, mounted on the headset, for periodically applying pressure to multiple locations on the head of a user.

In accordance with a second aspect of the present invention there is provided apparatus for treatment of migraine or headache comprising, a headset; and transducers, mounted on the headset, for periodically applying pressure to multiple locations on the head of a user, and wherein said pressure is applied with concomitant application of a gel on the head of a user.

There is also provided in accordance with a third aspect of the present invention a method for treatment of migraine or headache comprising: mounting a headset onto a user; measuring tissue conductivity; employing the measurements for determining preferred locations on the user's head for application of pressure; and employing transducers mounted on the headset for periodically applying pressure to multiple locations on the head of a user.

In accordance with a fourth aspect of the present invention there is provided a method for treatment of migraine or headache comprising: mounting a headset onto a user; employing transducers mounted on the headset for periodically applying pressure to multiple locations on the head of said user; and concomitantly applying gel to the head of said user.

In accordance with a preferred embodiment of the present invention, a conductivity sensor is employed for determining preferred locations on the user's head for application of pressure.

Preferably, the preferred locations are on the scalp and forehead of the user. 1 1 1 ,762/2 In accordance with a preferred embodiment of the present invention, the transducers are operated by pressurized fluid. In accordance with an alternative preferred embodiment of the invention, the transducers are operated electrically.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: Fig. 1 is a pictorial illustration of apparatus for treating headache and migraine mounted in operative engagement with the head of a user; Fig. 2 is a block diagram illustration of the apparatus shown in Fig. 1 in accordance with one embodiment of the present invention; Fig. 3 is a block diagram illustration of the apparatus shown in Fig. 1 in accordance with another embodiment of the present invention; Figs. 4A, 4B, 4C, 4D and 4E are simplified, illustrations of fluid operated head engagement assemblies constructed and operative in accordance with the present invention; and Figs. 5A, 5B, 5C, 5D and 5E are simplified illustrations of electrically-operated . head engagement assemblies constructed and operative in accordance with the present invention.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT Reference is now made to Fig. 1, which is a pictorial illustration of apparatus for treating headache and migraine mounted in operative engagement with the head of a user. The apparatus comprises a head engagement subsystem, generally indicated by reference numeral 10 and a remote subsystem, generally indicated by reference numeral 12, which is coupled to the head engagement assembly 10 by means of an umbilical cord 14.

The head engagement subsystem 10 typically comprises a head engagement element 16, which may be rigid, semi-rigid or soft and may be made of any suitable structural material . A chin strap 18 may be associated with element 16 for holding it securely in place on a user's head. Mounted on head engagement element 10 are a plurality of head engagement assemblies 20 and a gel injector 68, which will be described in greater detail hereinbelow with reference to Figs. 4A - 5E.

The remote subsystem 12 typically comprises a housing 22 in which are disposed, inter alia, a pneumatic fluid reservoir 24 and a pneumatic fluid pressure controller 26 in communication therewith, and an electrical power unit 28 which may be coupled to a source of mains power by means of a line cord 30.

The electrical power unit 28 powers electric valves 30, which operate pressure controller 26 in response to inputs from a controller 32. The controller 32 is programmed for various treatment schedules and receives inputs from a skin conductivity sensing unit 34 for determining the treatment sites.

Remote subsystem 12 communicates via umbilical cord 14 with the head engagement subsystem 10. The umbilical cord includes multiple fluidic conduits as well as low voltage electrical conductors for activating electrically operated transducers and for transmitting skin conductivity sensor outputs to the remote subsystem 12.

Reference is now made to Fig. 2 , which is a block diagram illustration of the apparatus shown in Fig. 1 in accordance with one embodiment of the present invention. In the illustrated embodiment of Fig. 2 , the head engagement subsystem includes a plurality of pneumatic transducers 50 , which are operative to provide pressure pulses to selected locations on a user's head, as well as a plurality of tissue conductivity sensors 52 , which are associated with the pneumatic transducers.

The remainder of the apparatus shown in Fig. 2 , forms part of the remote subsystem 12 (Fig. 1 ) . It is seen that a manual operation switch 60 and an electrical operation switch 62 are both provided. The electrical operation switch 62 couples the apparatus to a source of mains power. For manual activation of the transducers, the manual operation switch directly operates electric valves 30 , which are also controllable by a transducer schedule controller 64 , which may be embodied in controller 32 (Fig. 1 ) . Controller 64 receives electrical power via power unit 28 , which is operated by switch 62 .

Controller 64 interfaces with conductivity measurement system 34 , which interfaces with tissue conductivity sensors 52 .

Electric valves 30 provide pneumatic pulses to pneumatic transducers 50 and communicate via pressure controller 26 with pneumatic fluid reservoir 24. A gel injector 68 is provided to inject gel to transducers. The gel may be applied in conjunction with the pulsed pressure treatment.

Reference is now made to Fig. 3, which is a block diagram illustration of the apparatus shown in Fig. 1 in accordance with another embodiment of the present invention. In the illustrated embodiment of Fig. 3, the head engagement subsystem includes a plurality of electrical transducers 80, which are operative to provide pressure pulses to selected locations on a user's head, as well as a plurality of tissue conductivity sensors 82, which are associated with the electrical transducers 80.

The remainder of the apparatus shown in Fig. 3, forms part of the remote subsystem 12 (Fig. 1). It is seen that a manual operation switch 90 and a mains switch 92 are both provided. The manual operation switch provides inputs to a transducer schedule controller 94, which may be embodied in controller 32 (Fig. 1). Controller 94 receives electrical power via power unit 28, which is operated by switch 92.

Controller 94 interfaces with conductivity measurement system 34, which interfaces with tissue conductivity sensors 82. A gel injector 98 is provided to inject gel to transducers. The gel may be applied in conjunction with the pulsed pressure treatment .

Reference is now made to Figs. 4A, 4B, 4C, 4D and 4E which are simplified illustrations of fluid operated head engagement assemblies constructed and operative in accordance with the present invention.

Fig. 4A illustrates a head engagement assembly comprising a fluid operated piston, such as a pneumatic piston 100 which is coupled via a conduit 102 to a source of pressurized fluid. Fixed to piston 100 via a shaft 104 is a transducer head 106, typically including a plurality of pointed elements 108, typically formed of an elastic material. According to a preferred embodiment of the present invention, a tissue conductivity sensor 110, such as a Bio-Tech AWQ-104, available from itar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 108.

Fig. 4B illustrates an alternative embodiment of head engagement assembly wherein a plurality of pointed elements 120 are each associated with a separate fluid operated piston 122, supplied with pressurized fluid via a conduit 124. The pistons 122 are fixedly mounted on a common base 126, supported on a shaft 128.

Fig. 4C illustrates a composite head engagement assembly which comprises a fluid operated piston 130 which supports a common pusher element 134 within a housing 136. Disposed within housing 136 are a plurality of spring loaded pointed elements 138, one of which has associated therewith a tissue conductivity sensor 140.

Fig. 4D illustrates a composite head engagement assembly which comprises a fluid operated piston, such as a piston 100 which is coupled via a conduit 102 to a source of pressurized fluid. Fixed to piston 100 via a shaft 104 is a transducer head 106, typically including a plurality of pointed elements 108, typically formed of an elastic material. According to a preferred embodiment of the present invention, a tissue conductivity sensor 110, such as a Bio-Tech AWQ-104, available from Mitar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 108.

The assembly is coupled via a conduit 130 to a gel injector 68 shown in Fig. 1. Injector 68 is activated by controller 64 or 94 to inject gel via conduit 130 into the hollow volume of the base 106. Upon activation of piston 100, gel injected into the base 106 is forced through orifices 140 on the head of the user and simultaneously pressure pulses are applied by means of elements 108.

Fig. 4E illustrates an alternative embodiment of a head engagement assembly wherein a plurality of pointed elements 720 are each associated with a separately operated piston 722 supplied with pressurized fluid via a conduit 724. The pistons 722 are fixedly mounted on a common base 726, supported on a shaft 728. According to a preferred embodiment of the present invention, a tissue conductivity sensor 110, such as a Bio-Tech AWQ-104, available from Mitar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 720.

The assembly is coupled via a conduit 730 to a . gel injector 68 shown in Fig. 1. Injector 68 is activated by controller 64 or 94 to inject gel via conduit 730 into the hollow volume of the base 726. Upon activation of pistons 722, gel injected into the base 726 is forced through orifices 740 on the head of the user and simultaneously pressure pulses are applied by means of elements 708.

Reference is now made to Figs. 5A, 5B, 5C, 5D and 5E which are simplified illustrations of electrically-operated head engagement assemblies constructed and operative in accordance with the present invention.

Fig. 5A illustrates a head engagement assembly comprising an electrically operated transducer, such as a solenoid 150 which is coupled via a conductor to an electrical power source. Fixed to solenoid 150 via a shaft 154 is a transducer head 156, typically including a plurality of pointed elements 158, typically formed of elastic material. According to a preferred embodiment of the present invention, a tissue conductivity sensor 160, such as a Bio-Tech AWQ-104, available from Mitar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 158.

Fig. 5B illustrates an alternative embodiment of head engagement assembly wherein a plurality of pointed elements 170 are each associated with a separate solenoid 172, supplied with electricity via a conductor 175. The solenoids 172 are fixedly mounted on a common base 176, supported on a shaft 178.

Fig. 5C illustrates a composite head engagement assembly which comprises a solenoid 180 which supports a common pusher element 184 within a housing 186. Disposed within housing 186 are a plurality of spring loaded pointed elements 188, one of which has associated therewith a tissue conductivity sensor 190.

Fig. 5D illustrates a composite head engagement assembly which comprises an electrically operated transducer, such as a solenoid 850 which is coupled via a conductor to an electric power source. Fixed to solenoid 850 via a shaft 854 is a transducer head 856, typically including a plurality of pointed elements 858, typically formed of an elastic material. According to a preferred embodiment of the present invention, a tissue conductivity sensor 860, such as a Bio-Tech AWQ-104, available from Mitar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 858.

The assembly is coupled via a conduit 870 to a gel injector 68 shown in Fig. 1. Injector 68 is activated by controller 64 or 94 to inject gel via conduit 870 into the hollow volume of the base 856. Upon activation of solenoid 850, gel injected into the base 856 is forced through orifices 875 on the head of the user and simultaneously pressure pulses are applied by means of elements 858.

Fig. 5E illustrates an alternative embodiment of a head engagement assembly wherein a plurality of pointed elements 770 are each associated with a separately operated solenoid 772, supplied with electricity via a conductor 775. The solenoids 772 are fixedly mounted on a common base 776, supported on a shaft 778. According to a preferred embodiment of the present V invention, a tissue conductivity sensor 780, such as a Bio-Tech AWQ-104, available from Mitar, Israel Center for Advanced Therapeutic Equipment Ltd., 15 Chen Blvd., Tel-Aviv, Israel, is mounted on one of the pointed elements 770.

The assembly is coupled via a conduit 785 to a gel injector 68 shown in Fig. 1. Injector 68 is activated by controller 64 or 94 to inject gel via conduit 785 into the hollow volume of the base 776. Upon activation of pistons 772, gel injected into the base 776 is forced through orifices 790 on the head of the user and simultaneously pressure pulses are applied by means of elements 770.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims which follow: 111762/3

Claims (6)

1. Apparatus for treatment of migraine or headache comprising: a headset; a tissue conductivity sensor; and transducers, mounted on the headset, for periodically applying pressure to multiple locations on the head of a user.

2. Apparatus for treatment of migraine or headache comprising: a headset; at least one tissue conductivity sensor; and transducers, mounted on the headset, for periodically applying pressure to multiple locations on the head of a user, and wherein said pressure is applied with concomitant application of a gel on the head of a user.

3. Apparatus according to either of claims 1 and 2 and wherein said transducers comprise pneumatic transducers.

4. Apparatus according to either of claims 1 and 2 and wherein said transducers comprise solenoids.

5. Apparatus according to claim I wherein there is further provided control means connected between the tissue conductivity sensor and the transducers, the control means adapted to use the output of the sensor to determine which of the transducers to activate for application of pressure. 111762/3

6. Apparatus for treatment of migraine or headache substantially as hereinbefore described with reference to the attached drawings. ^ For the Applicant, Sanford T. Colb & Co. Advocates & Patent Attorneys C: 19806 HB-9411