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Title:
INFLATABLE HEADGEAR
Document Type and Number:
WIPO Patent Application WO/2018/011756
Kind Code:
A1
Abstract:
This disclosure relates to inflatable headgear, particularly to inflatable headgear for use in the prevention and/or treatment of epilepsy and extends to a method of preventing and/or treating epilepsy. The inflatable headgear includes an inflatable elongate band adapted to provide an annular inflatable arrangement, wherein at least a major portion of the annular inflatable arrangement is inflatable as a single component. The annular inflatable arrangement defines a diameter of adjustable dimension to securely fit about human heads of different dimensions. The headgear is for location about a head of a human suffering from epilepsy, such that inflation of the headgear exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue, and which in turn prevents and/or treats epilepsy.

Inventors:
SHEVEL, Elliot (Christiana, DE, 19702, US)
Application Number:
IB2017/054261
Publication Date:
January 18, 2018
Filing Date:
July 14, 2017
Export Citation:
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Assignee:
MIGRAINE MASTER LLC (16 West Main Street, Christiana, DE, 19702, US)
International Classes:
A42B1/20; A42B3/12; A61B5/022; A61B17/135; A61H23/04
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Claims:
CLAIMS:

1. A method of preventing and/or treating epilepsy in a human, said method comprising the following steps:

(i) locating an inflatable headgear around the head of a human suffering from epilepsy, the inflatable headgear comprising an inflatable elongate band adapted to provide an annular arrangement, wherein at least a major portion of the annular arrangement is inflatable, and wherein the annular inflatable arrangement defines a diameter of adjustable dimension, the inflatable headgear further comprising an inflation means in airflow communication with the annular inflatable arrangement;

(ii) inflating the inflatable headgear by actuating the inflation means such that the annular arrangement exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue;

(iii) allowing the inflated headgear to exert force for a pre-determined time period;

(iv) deflating the headgear; and

(v) repeating Steps (ii) and (iv).

2. The method of Claim 1, wherein the force is between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

3. The method of Claim 2, wherein the pre-determined time of Step (iii) is between about 10 and about 60 seconds.

4. The method of Claim 3, wherein Step (v), the repeating of Steps (ii) to (iv), takes place between about 2 and about 10 times as part of a single treatment regime.

5. The method of Claim 4, wherein the single treatment regime is repeated between about 2 and about 10 times per day to comprise a daily regime.

6. The method of Claim 5, wherein the daily regime is performed between about 1 and about 7 times per week.

7. The method of Claim 6, wherein the extra-cranial vascular system includes extracranial arteries including at least two of the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supraorbital artery; and supra-trochlear artery.

8. An inflatable headgear comprising: an inflatable elongate band adapted to provide an annular inflatable arrangement, wherein at least a major portion of the annular inflatable arrangement is inflatable, and wherein the annular inflatable arrangement defines a diameter of adjustable dimension; and an inflation means in airflow communication with the annular inflatable arrangement.

9. The inflatable headgear of Claim 8, wherein the major portion is greater than 50%, preferably a portion between 50% and 70%, more preferably a portion between 70% and 99%.

10. The inflatable headgear of Claim 9, further comprising a conduit between the inflatable elongate band and the inflation means.

11. The inflatable headgear of Claim 10, further comprising a pressure gauge, preferably the pressure gauge is a sphygmomanometer.

12. The inflatable headgear of Claim 11, wherein the inflation means is a pump.

13. The inflatable headgear of Claim 12, further comprising an adjustment means to allow, in use, adjustment of the diameter of the annular inflatable arrangement.

14. The inflatable headgear of Claim 13, wherein the inflatable elongate band is received into a material cover and/or housing, the material cover and/or housing providing an ergonomic surface for operative abutment against the head of the human when in use.

15. An inflatable headgear for use in the prevention and/or treatment of epilepsy, said headgear comprising: an inflatable elongate band adapted to provide an annular inflatable arrangement, wherein at least a major portion of the annular inflatable arrangement is inflatable, and wherein the annular inflatable arrangement defines a diameter of adjustable dimension; and an inflation means in airflow communication with the annular inflatable arrangement; wherein the headgear is for location around a head of a human suffering from epilepsy such that inflation of the headgear by actuating the inflation means exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue.

16. The inflatable headgear for use in the prevention and/or treatment of epilepsy of Claim

15, wherein the force is between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

17. The inflatable headgear for use in the prevention and/or treatment of epilepsy of Claim

16, wherein the force is exerted for a pre-determined time of between about 10 and about 60 seconds forming a single use.

18. The inflatable headgear for use in the prevention and/or treatment of epilepsy of Claim 17, wherein the single use is repeated between about 2 and about 10 times as part of a single treatment regime.

19. The inflatable headgear for use in the prevention and/or treatment of epilepsy of Claim

18, wherein the single treatment regime is repeated between about 2 and about 10 times per day to comprise a daily regime. 20. The inflatable headgear for use in the prevention and/or treatment of epilepsy of Claim

19, wherein the daily regime is performed between about 1 and about 7 times per week.

Description:
INFLATABLE HEADGEAR

FIELD OF DISCLOSURE

This disclosure relates to inflatable headgear, particularly to inflatable headgear for use in the prevention and/or treatment of epilepsy. The disclosure extends to a method of preventing and/or treating epilepsy.

BACKGROUND

Epilepsy is a neurological disease characterized by the onset of seizures. The precise cause of epilepsy is often unknown and is linked to brain trauma, birth defects and/or genetic mutations. The characteristic seizures are linked to an abnormally high activity of nerve cells in the cortex of the brain, and are often preceded by so-called auras. Auras may be include, for example, autonomic, sensory and/or motor phenomena alerting the epileptic as to the possible onset of seizure.

Epilepsy is typically treated by way of the administration of anticonvulsant pharmaceutical compositions. Typical anticonvulsants include phenobarbital, carbamazepine and phenytoin. In certain instances brain surgery including the removal of certain tissue is also associated with epilepsy treatment.

Pharmaceutical treatment and/or brain surgery both present risks to the patient and may cause unwanted side effects. The cost of treatment also poses a significant hurdle to many epileptics since the major occurrence of epilepsy is in the developing world. There exists a need for new medical devices and treatments for epilepsy.

SUMMARY

In accordance with a first aspect of this disclosure there is provided an inflatable headgear comprising: an inflatable elongate band adapted to provide an annular inflatable arrangement, wherein at least a major portion of the annular inflatable arrangement being inflatable, and wherein the annular inflatable arrangement may define a diameter of adjustable dimension; and an inflation means in airflow communication with the annular inflatable arrangement.

The term major portion is to be understood throughout this specification as a portion greater than 50%, preferably a portion between 50% and 70%, more preferably a portion between 70% and 99%.

The inflatable headgear may further comprise a conduit between the inflatable elongate band and the inflation means.

The inflatable headgear may further comprise a pressure gauge. The pressure gauge may be a blood pressure gauge. In a preferred embodiment of the invention the pressure gauge may be a sphygmomanometer. The pressure gauge may be manually operable and/or electronically operable.

The inflation means may be a pump. The pump may be manually operable and/or electronically operable. The inflatable headgear may further comprise an adjustment means to allow, in use, adjustment of the diameter of the annular inflatable arrangement.

When in use, the inflatable headgear is located around the head of a human and is inflated by said human such that the annular arrangement exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue. The extra-cranial vascular system may include extra-cranial arteries. The extra-cranial arteries may include at least two of, but not limited to, the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supra-orbital artery; and supra-trochlear artery. The force may be between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human. The inflatable elongate band may be received into a material cover and/or housing. The material cover and/or housing may provide an ergonomic surface for operative abutment against the head of the human when in use.

In accordance with a second aspect of this disclosure there is provided an inflatable headgear for use in the prevention and/or treatment of epilepsy, said headgear comprising: an inflatable elongate band adapted to provide an annular inflatable arrangement, wherein the annular inflatable arrangement may define a diameter of adjustable dimension; and an inflation means in airflow communication with the annular inflatable arrangement; wherein the headgear being for location around a head of a human suffering from epilepsy such that inflation of the headgear exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue.

In a preferred embodiment of the disclosure at least a major portion of the annular inflatable arrangement is inflatable.

The extra-cranial vascular system may include extra-cranial arteries. The extra-cranial arteries may include at least two of, but not limited to, the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supra-orbital artery; and supra-trochlear artery.

The force may be between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

The force may be exerted for a pre-determined time of between about 10 and about 60 seconds forming a single use. The single use may be repeated between about 2 and about 10 times as part of a single treatment regime. The single treatment regime may be repeated between about 2 and about 10 times per day to comprise a daily regime.

The daily regime may be performed between about 1 and about 7 times per week.

The inflatable headgear may be that described in the first aspect of this disclosure.

In accordance with a third aspect of this disclosure there is provided a method of preventing and/or treating epilepsy in a human, said method comprising the following steps:

(i) locating an inflatable headgear described in the first and/or second aspect of this disclosure around the head of a human suffering from epilepsy;

(ii) inflating the inflatable headgear by actuating the inflation means such that the annular arrangement exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue;

(iii) allowing the inflated headgear to exert force for a pre-determined time period;

(iv) deflating the headgear; and

(v) repeating Steps (ii) and (iv).

The extra-cranial vascular system may include extra-cranial arteries. The extra-cranial arteries may include at least two of, but not limited to, the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supra-orbital artery; and supra-trochlear artery.

The force may be between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

The pre-determined time of Step (iii) may be between about 10 and about 60 seconds forming a single use.

Step (v), the repeating of Steps (ii) to (iv) (the single use), may take place between about 2 and about 10 times as part of a single treatment regime. The single treatment regime may be repeated between about 2 and about 10 times per day to comprise a daily treatment regime.

The treatment regime may be performed between about 1 and about 7 times per week.

There is further provided for an inflatable headgear, use of said headgear, and/or a method of treating and/or preventing epilepsy, substantially as herein described, illustrated and/or exemplified with reference to any one of the accompanying diagrammatic drawings and/or examples.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the disclosure will be described below by way of example only and with reference to the accompanying diagrammatic drawings in which:

FIGURE 1 shows an inflatable headgear according to a first aspect of this disclosure in use secured around a human head; and

FIGURE 2 shows a top view of the inflatable headgear having variable length.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE DISCLOSURE

In general terms, the first to third aspects of this disclosure, as per the Summary, are repeated herein. However, the disclosure is further described, illustrated and/or exemplified herein with reference to non-limiting embodiments thereof. An inflatable headgear, in accordance with a first aspect of this disclosure, is referenced in the accompanying Figures 1 and 2 as reference numeral 10. Figure 1 shows the inflatable headgear 10, in use, secured around a head 12 of a human user. Figure 2 shows a top view of the inflatable headgear 10 shown to have a variable diameter.

The headgear 10 is shown to comprise an inflatable elongate band adapted to provide an annular inflatable arrangement 14 and defines a diameter of adjustable dimension. At least a major portion of the annular arrangement 14 is inflatable as a single component. The headgear 10 further comprises an inflation means 16 which is in airflow communication with the annular inflatable arrangement 14 via a conduit 18. The inflation means 16 is shown to be a manually operable rubber bulb pump 16. A blood pressure gauge in the form of a sphygmomanometer 20 is shown to be connected to the pump 16 and the conduit 18. The conduit 18 is shown to enter the annular inflatable arrangement 14 via a connection means 22. The connection means 22 typically includes a soft rubber or silicon lining to prevent user agitation.

The inflatable headgear 10 is shown to further comprise an adjustment means 24 to allow, in use, adjustment of the diameter of the annular inflatable arrangement 14. In Figures 1 and 2 the adjustment means is illustrated as a Velcro type strapping means facilitating variable diameters to suit different diameter heads 12 of users. It is to be understood that the adjustment means 24 is not limited to that shown in Figures 1 and 2, and may include various adjustments means known to the skilled person.

It is further to be understood that different types of inflation means 16 and blood pressure gauges 20 may be employed.

The inflatable elongate band which is adapted into the annular inflatable arrangement 14 is typically received into a material cover and/or housing 26. The figures show the material cover and/or housing 26. The material cover and/or housing 26 provides an ergonomic surface for operative abutment against the head 12 of the human, when in use. Preferably the material cover and/or housing is a soft material to avoid discomfort when the headgear 10 is in use. In a certain embodiment of the disclosure the material cover and/or housing 26 may be integrally formed with the annular inflatable arrangement 14.

When in use, the inflatable headgear 10 is located around the head 12 of a human and is inflated (by actuating the inflation means 16) by said human such that the annular arrangement 14 exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue. The extra-cranial vascular system may include extra-cranial arteries. The extra-cranial arteries may include at least two of, but not limited to, the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supra-orbital artery; and supra-trochlear artery.

The force exerted against the extra-cranial vascular system of the head is typically between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

The Applicant has surprisingly found that use of the inflatable headgear 10 described herein prevents and/or treats epilepsy, as is further described herein below.

The Applicant has found that an embodiment wherein at least the major portion of the annular inflatable arrangement 14 is inflatable as a single component provides better clinical outcomes in the prevention and/or treatment of epilepsy when compared to other possible embodiments. Without being limited to theory, the Applicant believes that a major portion of the annular inflatable arrangement 14 should be inflatable (as a single component) in order to ensure constriction of a certain extra-cranial arteries, when in use. An embodiment of the headgear wherein a minor portion of the annular arrangement is inflatable, alternatively wherein the annular arrangement comprises a plurality of discrete inflatable pockets, is not suitable for use in the treatment of epilepsy since neither embodiment ensures proper constriction of certain extra-cranial arteries.

In accordance with a second aspect of this disclosure there is provided an inflatable headgear 10 for the prevention and/or treatment of epilepsy. The inflatable headgear 10 may be any embodiment described in this disclosure herein above.

In accordance with a third aspect of this disclosure there is provided a method of preventing and/or treating epilepsy in a human, said method comprising the following steps:

(i) locating the inflatable headgear described in this disclosure around the head of a human suffering from epilepsy;

(ii) inflating the inflatable headgear by actuating the inflation means such that the annular arrangement exerts a force against the extra-cranial vascular system of the head, which in turn causes constriction of said extra-cranial vascular system, which in turn acts to shunt blood to intracranial tissue; (iii) allowing the inflated headgear to exert force for a pre-determined time period;

(iv) deflating the headgear; and

(v) repeating Steps (ii) and (iv).

The inflatable headgear 10 is typically that described in the first aspect of this disclosure herein above i.e. an embodiment wherein at least the major portion of the annular inflatable arrangement 14 is inflatable as a single component.

The force may be between about lOmmHg below a systolic blood pressure of the human to about lOmmHg above the systolic blood pressure of the human.

The pre-determined time of Step (iii) may be between about 10 and about 60 seconds, to provide a single use.

Step (v), the repeating of Steps (ii) to (iv) (the single use), may take place between about 2 and about 10 times as part of a single treatment regime.

The single treatment regime may be repeated between about 2 and about 10 times per day to comprise a daily treatment regime. The daily treatment regime may be performed between about 1 and about 7 times per week.

The extra-cranial vascular system may include extra-cranial arteries. The extra-cranial arteries may include at least two of, but not limited to, the following group: terminal branches of the extra-cranial carotid artery; superficial temporal artery, including frontal and parietal branches thereof; occipital artery; posterior auricular artery; angular artery; supra-orbital artery; and supra-trochlear artery.

The treatment regime may be carried out at the onset of aura to in use prevent the onset of seizure characteristic of epilepsy.

Without being limited to theory, the Applicant believes that the force exerted on the extracranial vasculature by the headgear 10 when in use acts to shunt blood to intracranial tissue. This increased blood flow to the intracranial tissue is thought to not only treat seizures in epilepsy but prevent the onset, and frequency of onset, of seizures. Epilepsy is understood to be a neurological disease treated with chemical medicines or sometimes brain surgery, and is not known to be treated by redirecting blood flow to intra-cranial tissue. The Applicant unexpectedly and surprisingly found that the headgear according to this disclosure had use in the treatment and/or prevention of epilepsy by providing a blood shunt to intracranial tissues.

The Applicant has surprisingly found that use of the headgear 10 in epilepsy sufferers successfully treats and/prevents the symptoms of epilepsy, including for example treating and/or preventing epileptic attack or seizure. Furthermore, the Applicant has found that when an epilepsy sufferer uses the headgear 10 at the onset of aura (a known warning sign of a possible epileptic attack or seizure), the attack or seizure typically does not occur. Use of the headgear 10 in epilepsy sufferers has significantly improved their day to day lives and reduced or even stopped systems associated with epilepsy.

The Applicant believes that the disclosure described herein at least ameliorates one of the disadvantages known in the current state of the art. The invention provides a headgear for use in a non-chemical and non-surgical treatment of epilepsy.

While the invention has been described in detail with respect to specific embodiments and/or examples thereof, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing may readily conceive of alterations to, variations of and equivalents to these embodiments. Accordingly, the scope of the present invention should be assessed as that of the claims and any equivalents thereto, which claims are appended hereto.