Helmet Assisted Canalith Repositioning Maneuver

1. Field of the Invention

The invention relates to an apparatus and the use thereof to assist in the Canalith Repositioning Maneuver.

2. Description of the Prior Art

Approximately 3 million of the 250 million people in the United States suffer from vertigo of some duration each year. Vertigo is the most common physician visit diagnosis in patients over 65 years of age. 17% of patients who have vertigo have benign paroxysmal positional vertigo. Positional vertigo is characterized by vertigo when the patient moves into the effected ear downward position. The patient may also have symptoms of vertigo with looking up or looking down. The diagnosis is clinically confirmed by placing the patient in the effected ear down position and observing a characteristic rotary jerking motion of the eyes. The natural history of positional vertigo is one of spontaneous remission. Recurrence is common and can last for weeks to months. One ear is usually involved but reports of 15% of bilateral ear involvement have been made.

Positional vertigo is caused by dislodgment of naturally occurring inner ear calcium carbonate crystals (121, FIG. 1). When these crystals fall from their normal position in the inner ear (the utricular macula (123), two events that effect one of the inner ear sensors (the posterior semi-circular canal) can occur. (1.) When the patient places the effected ear downward, the loosened crystal (121-L) causes motion of the rotation sensor (127), causing the patient to sense vertigo. (2.) When the patient places the effected ear downward, the loosened crystals (121-B) move together within the membranous semicircular canal (141), and their aggregate effect is to cause motion of the endolymphatic fluid (95). The motion of that fluid and the motion of that fluid in a narrow channel (141), the membranous semi-circular canal of small cross sectional diameter, has a significant effect on the much broader surfaced area (127) rotation sensor, causing the patient to sense vertigo.

In those patients whom multiple loosened crystals (121-B) have collected in the posterior semi-circular canal, a treatment is available.

The presence of loosened crystals (121-B) was identified and their effect on the rotation sensor (127) is explained by John Epley, M.D., approximately eight years ago. Dr. Epley hypothesized and then demonstrated that by rotating the patient's head in the plane of the effected inner ear rotation sensor (the posterior semicircular canal, 131), the loosened crystals (121-B) can be caused to fall through the fluid of the posterior membranous semi-circular canal 141 away from the rotation sensor (127) and fall into the large compartment of the endolymphatic fluid compartment (93) (128) the utricle. In this position crystals delivered by this head rotation maneuver into the utricular portion of the endolymphatic space cause fewer symptoms and presumably dissolve more rapidly than in the membranous posterior semi-circular canal much smaller fluid space (141).

The technique that Dr. Epley described has been reported by multiple authors and is thought to be a good and valid technique.

The performance of this Canalith repositioning maneuver (Eply maneuver) by other physicians or paramedical personnel is difficult to teach. Inconsistent performance and performing this maneuver in an incorrect method is a continuing problem. Consistent performance of this maneuver by the apparatus of the invention allows a method to help paramedical personnel consistently perform the Epley maneuver or allows the patient to perform the maneuver consistently without supervision.

The literature reports that the use of a head vibrator for some period of time prior to performance of an Canalith repositioning maneuver increases the efficiency of the movement of the loosened crystals (121-B) from the posterior semi-circular canal membranous labyrinth into the utricle. A vibrator can be attached to the apparatus of the invention. The vibrator may be attached internally or externally to the apparatus.

It is an object of the invention to provide an apparatus to be worn on the head of a human to act as a guide to allow one to obtain consistent performance of the Canalith Repositioning Maneuver by the medical personnel or by the patient without medical attention when the diagnosis is clear. The apparatus also allows the patient to treat medically diagnosed benign paroxysmal positional vertigo when the episodes are recurrent. The technique does not require return of the patient to a medical facility or medical personnel.

In one embodiment, the apparatus comprises two planar anterior surfaces and two posterior planar surfaces located such that the two anterior surfaces are at the front of the apparatus and the two posterior surfaces are at the rear of the apparatus. Opposite anterior and posterior surfaces flare outward and downward relative to each other. A cavity is formed in the apparatus from the lower end. This apparatus may be used to treat either ear.

In one embodiment, each surface forms an angle of about 20 degrees relative to a central axis extending between the upper and lower ends of the apparatus and as seen from a top plan view, the adjacent surfaces define an angle of about 90 degrees.

In another embodiment, the apparatus may comprise the two posterior surfaces and only one of the anterior surfaces such that separate apparatuses are employed to treat either ear.

In a further aspect, a vibrator may be attached to the apparatus.

Initially the patient's head may be vibrated with a vibrator. If the right ear is effected, the patient lays on his or her back with the right posterior surface against a support surface, then with the left posterior surface against the support surface and then rolls over to allow the left anterior surface to be placed against the support surface. If the left ear is effected, the patient lays on his or her back with the left posterior surface against the support surface, then with the right posterior surface against the support surface and then rolls over to allow the right anterior surface to be placed against the support surface.

FIG. 1 illustrates the middle and inner ear of a human.

FIGS. 2 and 3 illustrate the apparatus of the invention on the head of a person as seen from the left side and the front side of the person.

FIG. 4 is a top view of the apparatus of the invention.

FIG. 5 is a side view of the apparatus of the invention as seen from the front left side.

FIG. 6 is a side view of the apparatus of the invention as seen from the front right side.

FIG. 7 is a cross sectional view of the apparatus of the invention as seen along lines 7--7 of FIG. 3.

FIG. 8 is an end view of the apparatus of FIGS. 2-7 on the head of a person with the left rear side against the floor.

FIG. 9 is a view of FIG. 8 as seen along lines 9--9 thereof.

FIG. 10 is an end view of the apparatus of FIGS. 2-7 on the head of a person with the right rear side against the floor.

FIG. 11 is a view of FIG. 10 as seen along lines 11--11 thereof.

FIG. 12 is an end view of the apparatus of FIGS. 2-7 on the head of a person with the right front side against the floor.

FIG. 13 is a view of FIG. 12 as seen along lines 13--13 thereof.

FIG. 14 is an end view of the apparatus of FIGS. 2-7 on the head of a person with the left front side against the floor.

FIG. 15 is a view of FIG. 14 as seen along lines 15--15 thereof.

FIG. 16 is an electrical schematic of the circuitry for operating the vibrators.

FIGS. 17-22 illustrates an integral guide and helmet of a second embodiment of the invention.

FIG. 17 is a right side view of the apparatus.

FIG. 18 is a left side view of the apparatus.

FIG. 19 is a front view of the apparatus.

FIG. 20 is a top plan view of the apparatus.

FIG. 21 is a cross-section outline of FIG. 20 taken along the lines 21--21 thereof.

FIG. 22 is a cross-section outline of FIG. 20 taken along the lines 22--22 thereof.

In order to complete the previous description of the human ear, the external ear canal, middle, and inner ear of a human are identified by reference numerals 57, 53, and 55 respectively in FIG. 1. Members 61 and 63 are the malleus and incus respectfully. Members 71, 73, 75 are the stapes bone. The cross hatching 81 indicates bone. Member 91 is a transparent membrane which forms and defines a endolymphatic fluid compartment 93 containing transparent endolymphatic fluid 95. The fluid compartment 93 also extends around the center bone structure 81C. The space 99 between the membrane 91 and the outer bone structure 81 is a fluid compartment containing transparent perilymphatic fluid 101.

Referring now to FIGS. 2-7 the apparatus of the invention is identified by reference numeral 221. It comprises four outer walls 223, 225, 227 and 229 having flat outer surfaces or planes each in the form of a trapezoid with each trapezoid having parallel upper and lower edges of different lengths and two side edges of equal lengths. The side edges of the walls 223, 225, 227 and 229 are joined to form four corners 231, 233, 235, 337. Each of the surfaces 223, 225, 227, 229 are identical in shape and dimension. The lower edges of the walls 223, 225, 227, 229 define a square bottom 241 in a lower plane and the upper edges of the walls 223, 225, 227, 229 define square top 243 in an upper plane parallel to the plane of the bottom 241. As seen in a top plan view of the apparatus in FIG. 4, the surfaces of each of the surface pairs 223, 225; 225, 227; 227, 229; and 229, 231 are at about 90 degrees relative to each other such that each of the angles .beta. is equal to about 45 degrees. The corners 231 and 235 define a plane which bisects the apparatus and the corners 233 and 237 define a plane which bisects the apparatus.

Each of the angles .alpha. between the plane 245 and the surfaces 225 and 229 is equal to about 20 degrees and the angles .alpha. between the plane 247 and the surfaces 223 and 227 is equal to about 20 degrees. In FIGS. 5 and 6 each of the lower angles .alpha. is equal to about 20 degrees. In FIG. 4, reference numeral 249 defines a central axis passing through the lower and upper ends of the walls 223, 225, 227, and 229.

The inside of the apparatus 221 has an inner helmet 251 connected to the outer walls 223, 225, 227, and 229 by way of plastic material 253 which may be a suitable plastic foam. The inner helmet has a cavity 255 with a lower opening 257 for receiving a person's head shown at 261. The inner helmet 251 is attached such that when a person wears the apparatus 221, corner 231 will be at the front of the person's head, corner 235 will be at the rear of the person's head and corners 237 and 233 will be on the left and right sides of the person's head as shown in FIGS. 2-4 and 7. In FIG. 4, the person's head is shown at 261 in dotted form with his or her nose indicated at 261N. In this position, the surface planes 223 and 225 are at the front left and front right of the person's head and the surface planes 229 and 227 are at the rear left and rear right of the person's head. The cavity 255 shaped as shown allows the helmet and apparatus to be worn on the head only in this manner.

Preferably two vibrators 271 and 273 are connected to the inner helmet 261 on each side of and in line with the ears as illustrated in FIGS. 4, 7, and 16. Preferably each of the vibrators will be operated by a battery 275 with an exterior switch 277 and 279.

A chin strap 281 comprising strap members 281A and 281B is connected to each side of the inner helmet 251 such that the strap members may be located below the chin and connected together with the aide of a buckle 283 as shown in FIGS. 2, 3, and 7 to secure the apparatus 221 in place on the head of a person.

The positions in which the head is held are described with the wearer in the anatomic position, supine. The planes of the head are described as sagittal being a vertical plane running directly antero-posteriorly through the center of the skull; coronal plane, a vertical plane running supero-inferiorly and perfectly lateral to lateral; the horizontal plane, horizontal with the surface. The four planes 223, 225, 227, and 229 of the apparatus 221 are divided evenly between the right and the left sides of the skull. The two posterior planes 227 and 229 are equal to each other and the two anterior planes 223 and 225 are equal to each other.

While the wearer is lying in an anatomic position, supine, the posterior planes 227 and 229 of the helmet guide the wearer's head into positions: 1) twenty degrees of neck extension and forty-five degree head turn to the right; 2) twenty degrees of neck extension and forty-five degrees turn of the head to the left from the anatomic position. The front plane 225 of the apparatus with the patient lying in a full lateral position, holds the neck in a twenty degree flexed position with the head rotated forty-five degrees to the right. When the patient is in full left lateral position, the plane 223 of the helmet holds the head in a twenty degree flexed position and forty-five degree turn to the left from the anatomic position.

The process of helmet assisted Canalith repositioning maneuver is as follows. A determination is made as to the ear of origin of positional vertigo. This can be done by the patient having identified the ear, which when placed downward, will cause rotary nystagmus, and when placed upward will cease to cause nystagmus. The ear which in a downward position causes vertigo, is known to be the ear causing vertigo. The determination of positional vertigo can also be made by professional medical history and balance testing mechanisms and shared with the patient. If the helmet 221 does not have the vibrators 271 and 273, a vibrator is used to vibrate the head next to the effected ear. After the vibration of the head, the apparatus is placed on the patient and the chin strap 281 made firm. If the apparatus 221 has the vibrators 271 and 273, the apparatus 221 is placed on the patient's head and the chin strap 281 connected in place. The vibrator next to the effected ear is operated by closing its switch 277 or 279 for a period of time. With the vibrator running, the patient then is instructed to lie backward on a one inch thick mat 291 allowing his effected ear to hang off the mat, allowing the helmet to touch the floor 293. The entire surface of the back effected ear side surface plane is place flatly against the floor surface. After a 15 to 20 second pause, the patient should become vertiginous. This vertigo will last for some variable period of time (usually less than 90 seconds). As the vertigo decreases to only 10% of its maximum, the patient turns his or her head 90 degrees such that his non-effected ear is more downward than the effected ear. The entire surface of the back, non-effected ear, helmet plane is placed against the flat floor surface. The patient should expect some increase in dizziness 15 to 20 seconds after this maneuver. Again, when the symptoms have decreased to 10% of his or her non-effected ear downward plane vertigo, the patient can roll onto his or her non-effected ear side into a full lateral position. Following this, the patient rolls his or her head so that the non-effected ear front plane of the apparatus is flat against the floor. For the third time the patient should expect some increases in his or her dizziness. After 90% of the evoked dizziness in this position resolves (60 to 90 seconds), the patient sits up from his or her lateral position with his or her nose trailing. Immediately upon reaching a full upright position the chin is tipped downward for 10 seconds. One maneuver is now complete.

Referring to FIGS. 10, 11, 8, 9, and 14 15 assume that the patient's right ear is effected. With the apparatus 221 on the patient's head the patient lays with his or her back on the pad 291 with the surface plane 227 of the apparatus flat against the floor as shown in FIGS. 10 and 11. After a period of time as indicated above, the patient turns his or her head 90 degrees such that the surface plane 229 is flat against the floor 293 as shown in FIGS. 8 and 9. After a period of time as indicated above, the patient rolls over on his or her left full lateral (on left shoulder and hip) to place the surface plane 223 flat against the floor as shown in FIGS. 14 and 15, for a period of time and then the patient sits up as indicated above and the apparatus 221 then is removed.

Referring to FIGS. 8, 9, 10, 11, 12, 13 assume that the patient's left ear is effected. With the apparatus 221 on the patient's head, the patient lays with his or her back on the pad 291 with the surface plane 229 of the apparatus flat against the floor 292 as shown in FIGS. 8 and 9. After a period of time as indicated above, the patient turns his or her head 90 degrees such that the surface plane 227 is flat against the floor 292 as shown in FIGS. 10 and 11. After a period of time, as indicated above, the patient rolls over on his or her full lateral (right should and hip) to place the surface plane 225 flat against the floor as shown in FIGS. 12 and 13, for a period of time and then the patient sits up as indicated above and the apparatus 221 then is removed.

In one embodiment, the inner helmet 251 and the helmet walls 223, 225, 227, and 229 may be formed of a suitable hard plastic material.

Referring to FIGS. 17-23, there is disclosed another embodiment wherein the planar surfaces 223, 225, 227, and 229 are integral with the helmet 251 which helmet is similar to the helmet 251 of the embodiment of FIGS. 2-16 except in a top plan view of the helmet, the helmet is circular as shown in FIG. 30. The planar surfaces 223, 225, 227, and 229 are circular in shape. Surfaces 223 and 227 form angles .alpha. equal to about 20 degrees relative to the vertical planes 323 and 327 and surfaces 225 and 229 form angles .alpha. equal to about 20 degrees relative to the vertical planes 325 and 329. Each of the angles .beta. in planes parallel to the tops and bottoms of planar surfaces 223, 225, 227, and 229 is equal to about 45 degrees such that adjacent surfaces are about 90 degrees relative to each other. The helmet is worn such that the surfaces 223, 225, 227, and 229 are located in the positions shown in FIGS. 17-20.

The apparatus of FIGS. 17-23 is used in the same manner as the apparatus of the embodiment of FIGS. 2-16.

In the embodiments of FIGS. 2-16 and 17-22 it is understood that the apparatus may have only one front planar surface and two rear surfaces. For treating either the left or right ear, two of the apparatus will be employed. One apparatus will have the two rear surfaces 227 and 229 and only front surface 223 and the other apparatus will have the two rear surfaces 227 and 229 and only front surface 225.