Surgery – Miscellaneous
Reexamination Certificate
2000-10-24
2003-05-27
Lacyk, John P. (Department: 3736)
Surgery
Miscellaneous
Reexamination Certificate
active
06568396
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a method and apparatus for resolving benign paroxysmal positional vertigo (BPPV).
2. Background
BPPV
BPPV is classically used to refer to vertigo caused by loosened otoconia crystals in the posterior semicircular canal, the most common inner ear semicircular canal effected by loosened otoconia. To those trained in the art, given the current understanding of the pathophysiology of BPPV, the definition of BPPV is positional vertigo caused by loosened crystals in any of the membranous semicircular canals moving in response to gravity. This more generalized definition is the one used in this application. I will refer to classic posterior semicircular canal positional vertigo as posterior BPPV or PBPPV, horizontal BPPV as HBPPV and superior semicircular canal BPPV as SBPPV.
Pathophysiology of BPPV
BPPV is caused by 1) naturally occurring calcium carbonate crystals becoming dislodged and falling from their normally occurring position on the utricular macula and 2) a significant number of the crystals coming to be located in a membranous semicircular canal. When the patient places the head such that a particular semicircular canal is vertical, the loosened crystal(s) causes motion of the rotation sensor causing the patient to sense vertigo. These symptoms typically resolve when the loosened crystal dissolves in the surrounding endolymphatic fluid. If the loosened crystals can be moved out of the affected membranous SCC then the patient symptoms are markedly decreased or resolved.
Incidence of BPPV
90 million Americans (42% of the population) will experience vertigo some time in their life. Approximately three million people of the 250 million people in the US suffer some vertigo each year. Vertigo is the most common physician visit diagnosis in patients over 65 years of age. Seventeen percent of patients who have dizziness have benign paroxysmal positional vertigo (BPPV). According to Fife
1
, 91% of the BPPV patients were thought to have involvement of the posterior semicircular canal, 6% involvement of the horizontal canal (7.8% according to Takegoshi
2
), and 3% involvement of the superior (or anterior) semicircular canal. This application is directed to a new method and apparatus for the diagnosis and treatment of posterior BPPV and the treatment of benign paroxysmal positional vertigo in the horizontal and superior semicircular canals.
Types of BPPV
Posterior BPPV
PBBPV's hallmark is vertigo when the patient moves into the affected ear downward position. The patient may also have symptoms of dizziness with looking up, or looking down. The diagnosis is clinically confirmed by placing the patient in the affected ear down position and watching a characteristic rotary motion of the eyes. Although some cases of BPPV follow head trauma, most cases have spontaneous onset of unknown origin. The natural history of positional vertigo is one of spontaneous remission, typically over 6 weeks. Recurrence is common and can last from weeks to months.
One ear is usually involved but reports of up to 15% of bilateral ear involvement have been made.
PBPPV is caused when a significant number of the loosened crystals come to be located within the posterior semicircular canal.
PBPPV Treatments
In 1980 Brandt Daroff
3
described a sequence of maneuvers in which the patient sat on the edge of a bed/surface and lay down laterally with the head touching the surface. After the symptoms resolved he sat up and lay down on the opposite side. This was done every three hours while awake and terminated after two symptom-free days. This maneuver was thought to free the otolithic debris which was attached to the cupula of the posterior semicircular canal ampulla.
Semont
4
described what he called a Liberatory maneuver in which the patient was rapidly moved from a sitting position to the provoking position and kept in that position for 2-3 minutes. The patient was then rapidly brought up through the sitting position to lie on the contralateral side with the head turned downward 45 degrees. The therapist maintained the alignment of the neck and head on the body. The patient stayed in this second position for 5 minutes. In this second position the vertigo reappears and resolves. After the vertigo resolved the patient was slowly returned to a seated position and remained vertical for 48 hours thereafter. This technique was thought to work by causing the debris within the posterior semicircular canal to fall out of the canal.
Norre
5,6,7
described the use of vestibular rehabilitation maneuvers for the treatment of BPPV. Some support for this use of this compared to the liberatory and Epley canalith repositioning maneuvers has been expressed.
Epley
8,9
studied and refined Semont's Liberatory maneuver
4
. Epley's maneuver is now thought to be the most effective technique for moving the crystals out of the posterior membranous SCC (posterior canalith repositioning maneuver).
This maneuver is defined by Epley
8,9
as being made up of 6 positions: Start, and Positions
1
,
2
,
3
,
4
, &
5
. The start position is the patient seated upright in an examination chair or on a table looking forward with the operator behind the patient and a mastoid oscillator applied to the effected ear behind the ear (ipsilateral mastoid area). In position
1
, the patient is lying supine with the neck extended 20 degrees and the head turned 45 degrees toward the effected ear downward position. In position
1
, while the neck continues to be extended 20 degrees, the head is turned 90 degrees toward the unaffected ear i.e. 45 degrees from vertical in the direction of the unaffected ear into position
2
. To go from position
2
to position
3
, the neck is kept extended 20 degrees, the patient rolls onto the unaffected ear side of their body and the head is rolled into position
3
. In position three, the head (nose) is pointed 135 degrees downward, affected ear upward, from the supine position. Keeping the head (nose) in the 135 degrees downward position, the patient is brought up to a sitting position, position
4
. In position
5
, the head is turned forward and the chin downward 20 degrees. Each position is held until the induced nystagmus stops (“approaches termination”).
Harvey
10
described a modification of Semont's Liberatory maneuver which is very similar in its positions to that of Epley's canalith repositioning maneuver.
Katsarkas
11
showed a modification of the Epley canalith repositioning maneuver which he developed. In his maneuver, after the Epley position
3
, he extends the neck as far as is reasonably possible to allow (he believes) the otoconia to fall into and through the common crus portion of the posterior semicircular canal crystal removal route.
Best PBPPV Treatment Observations
One skilled in the art will recognize that the head maneuver to relieve PBPPV can be done in an large (theoretically infinite) number of positions. That is, this maneuver could be done using the same head movement sequence outlined by the six positions of the posterior CRP maneuver, but it could be done such that instead of Epley positions
1
,
2
and
3
being 90 degrees from the previous positions, the maneuver could be divided into five positions each 45 degrees from the position that preceded it and 45 degree from the position that follows it. If resolution of clinical vertigo caused by each position was used as the indicator to proceed to the next position, this theoretical five position maneuver would be as effective in the resolution of BPPV as Epley described in his positions
1
,
2
and
3
.
In the same way, those skilled in the art will recognize that this rotation of the head could be broken up into many (theoretically an infinite number of) positions. To one skilled in the art, the clinical use of a complex multipositioned maneuver is not clinically possible because of the increased difficulty of correct and consistent positioning when a multipositional maneuver is done manually. This difficulty is increased further for the
Lacyk John P.
Zobal Arthur F
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