FORM 2
The Patent Act 1970
(39 of 1970)
&
The Patent Rules  2005

COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)

TITLE OF THE INVENTION

“SYSTEM AND METHOD FOR AUTOMATED TREATMENT OF BPPV”
APPLICANTS:

Name : HCL Technologies Limited

Nationality : Indian

Address : HCL Technologies Ltd  50-53 Greams Road 
Chennai – 600006  Tamil Nadu  India

The following specification particularly describes and ascertains the nature of this invention and the manner in which it is to be performed:-

FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically  it relates to a device for the treatment of vestibular disorders involving symptoms of dizziness  vertigo and/or imbalance.

BACKGROUND OF INVENTION
[002] Dizziness  including vertigo and imbalance  is one of the most common complaints presenting to the physician. Vertigo is a disabling sensation in which the affected individual feels that either he himself or his surroundings are in a state of constant movement. It is most often a spinning sensation. It is a symptom of a disease & not a disease per se. Benign paroxysmal positional vertigo (BPPV) is classically used to refer to vertigo in which the patient complains of brief episodes of rotary vertigo precipitated by certain critical head positions. . BPPV is caused by loosened ‘otoconial debris’ consisting of crystals of calcium carbonate in the posterior semicircular canal  released from the degenerating macula of the utricle. The otoconial debris floats freely in the endolymph and the most common inner ear semicircular canal is affected by the loosened otoconia. During certain critical head positions the ‘otoconia’ settles on the cupula of the posterior semicircular canal it causes vertigo. Further  BPPV can be defined as positional vertigo caused by loosened crystals in any of the membranous semicircular canals moving in response to gravity.
[003] Although these symptoms may be caused by a variety of abnormal conditions such as 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.
[004] 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.
[005] The classical BPPV disorder is posterior canal benign paroxysmal positional vertigo (PBPPV). Other BPPV disorder forms such as horizontal BPPV (HBPPV) and superior semicircular canal BPPV (SBPPV) occur when otoconia find their way into the superior and lateral canals which provide balance in the vertical and horizontal planes. These forms of BPPV are far less common and have a less symptomatic course.
[006] In PBPPV  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.
[007] PBPPV is caused when a significant number of the loosened crystals come to be located within the posterior semicircular canal.
[008] Initially  a series of exercises were developed for BPPV treatment  which lead to a more rapid resolution of symptoms  these exercises were not therapeutic but rather caused the patient to become accustomed to the symptoms. Further  these exercises required the regular induction of vertigo.
[009] Brandt Daroff 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.
[0010] Semont described 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.
[0011] Norre 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.
[0012] Epley studied and refined Semont""s Liberatory maneuver. Epley""s maneuver is considered to be the most effective technique for moving the crystals out of the posterior membranous SCC (posterior canalith repositioning maneuver). Epley""s maneuver 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.
[0013] Horizontal BPPV (HBPPV) was first recognized by McClure who reported 7 cases with brief episodes of positional vertigo associated with horizontal direction changing positional vertigo. Subsequent studies have reported several variations in the type of nystagmus produced by horizontal canal BPPV  including geotropic and ageotropic direction changing positional nystagmus.
[0014] The clinical characteristics of HBPPV are 1) brief episodes of positional vertigo and 2) paroxysmal bursts of horizontal positional nystagmus and 3) lack of any other identifiable central nervous system disorder.
[0015] Epley describes treating horizontal canal HBPPV with a 360 degree "barrel roll" away from the involved ear  keeping the horizontal canal in the earth vertical plane. To avoid dumping particles from the utricle back into the horizontal canal at the end of the procedure  the patient was returned to upright without first moving to the straight supine position. Further  Epley found that less agile patients can find success by turning the head only 135 degrees from supine  opposite the involved ear.
[0016] Aforementioned repositioning maneuvers require physician’s guidance while performing the maneuver. Further  these maneuvers are somewhat difficult for patients to remember correctly. Incorrectly performed particle repositioning maneuvers are unlikely to be therapeutic. Furthermore  singular neurectomy and posterior semi-circular canal occlusion are highly effective surgical procedures  but require a general anesthetic and the associated surgical morbidity.
[0017] The present maneuver devices face several difficulties with the design and use of these devices. Hence  the patients find great difficulty in handing and using these maneuver devices effectively.

OBJECT OF INVENTION
[0018] The principal object of the embodiments herein is to enable a method for feedback in the form of audio or voice based instructions which can be multilingual.
[0019] Another object of the invention is to enable a method to eliminate the assistance required by patients while performing maneuver.

SUMMARY
[0020] Accordingly the invention provides an apparatus for treating Benign Paroxysmal Positional Vertigo (BPPV) in a patient  the apparatus comprising at least one means configured for detecting position of head of the patient  when performing Epleys’ maneuver on the patient; and providing audio instructions  based on position of head of the patient and time the position of head of the patient has been held.
[0021] Also  provided herein is a method for treating Benign Paroxysmal Positional Vertigo (BPPV) in a patient using an apparatus  the method comprising of detecting position of head of the patient  when performing Epleys’ maneuver on the patient; and providing audio instructions  based on position of head of the patient and time the position of head of the patient has been held.
[0022] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood  however  that the following descriptions  while indicating preferred embodiments and numerous specific details thereof  are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof  and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF FIGURES
[0023] This invention is illustrated in the accompanying drawings  throughout which like reference letters indicate corresponding parts in the various figures. The embodiments herein will be better understood from the following description with reference to the drawings  in which:
[0024] FIG. 1 is a block diagram illustrating BPPV treatment apparatus  according to embodiments as disclosed herein;
[0025] FIG. 2 is a block diagram illustrating BPPV treatment apparatus  according to embodiments as disclosed herein;
[0026] FIG. 3 is a block diagram illustrating BPPV processor  according to embodiments as disclosed herein; and
[0027] FIG. 4 is a flow chart which illustrates the process of BPPV treatment  according to embodiments as disclosed herein.

DETAILED DESCRIPTION OF INVENTION
[0028] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein can be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly  the examples should not be construed as limiting the scope of the embodiments herein.
[0029] The embodiments herein achieve a System and method for automated treatment of BPPV. Referring now to the drawings  and more particularly to FIGS. 1 through 4  where similar reference characters denote corresponding features consistently throughout the figures  there are shown preferred embodiments.
[0030] The present invention is an apparatus which can be worn by a patient as a goggle or glasses. The apparatus provides real-time treatments of vestibular disorders such as BPPV by automating the Epley’s maneuver. The apparatus can facilitate the patient and/or an observer (who may be a person with medical training or a lay person) to perform the maneuver without assistance. The apparatus can provide audio/voice feedback to the person about head position and the status of the particles within the patient""s posterior semicircular canal.
[0031] FIG. 1 is a block diagram an example of a BPPV treatment apparatus  according to embodiments as disclosed herein. The apparatus comprises of frame structure which can be adapted for wearing on a patient’s head in a condition of relative positional stability. The apparatus further comprises of an accelerometer (which may be a multi axis accelerometer)  gyro-sensor  time counter  micro-processor  embedded software  battery and audio output.
[0032] In an embodiment  the goggle-like frame structure may include an eye-bridging housing structure and a head-wrap band which extends from the housing in a loop which may enable the frame structure to be secured appropriately  in a goggle-wearing fashion  to and around a human subject""s head. Further  length of the band can be adjusted in order to tighten the band comfortably around the patient’s head. The frame can be placed securely on the patient’s head with complete stability with no relative motion between the frame structure and the head under normal subject head-motion conditions. The 3-axis gyro-sensor measures or maintains orientation (using the principles of angular momentum)  rate of rotation around a particular axis and tilting (2 axis at a time  due to gravity  left/right  upward/backward) of the patient’s head. The gyro-sensor measures non-zero value for the rate of rotation around an object such as the patient’s head roll axis  as long as the object is rolling. However  the gyro-sensor measures zero if the roll stops. The gyro-sensor’s information can pertain to bandwidth and frequency available to the extent of zero frequency. Further  implementation of gyro-sensor is less complicated as onetime integration of gyro-sensor can be sufficient to achieve angular displacement. Further  gyro-sensors are less sensitive to linear mechanical movements. The time counter in the apparatus can be used to ensure that a patient did hold his/her head in the same position for the prescribed time. The time counter can start as soon as the maneuver starts and can display the status of the timer. Once the prescribed time is over  the time counter can raise an alarm to alert the patient and/or any other person. Further  the apparatus may comprise of several input means such as power on/off key  headset on/off key  reset key  volume rocker and microphone. A user can switch on/off the apparatus with the help of power on/off key on the apparatus. Further  the feedback output port can be controlled by the headset on/off key. A user can reset the apparatus at any point of time either to restart the maneuver or to abort the maneuver. Further  a user can input any audio data which may be used by the apparatus.
[0033] It should be noted that only few of the elements of the apparatus have been shown in the invention. Any person having ordinary skill in the art may be able to include further elements in the apparatus.
[0034] The goggle like apparatus is an exemplary apparatus. It may be obvious to a person of ordinary skill in the art to construct the apparatus in the form of goggles  headphones  headbands  hair bands  caps  ear muffs  helmets or any other apparatus which may be worn in a secure manner on the head of a patient.
[0035] FIG. 2 is a block diagram illustrating BPPV treatment apparatus  according to embodiments as disclosed herein. The apparatus comprises of input means such as power on/off key 202  headset/speaker 203  on/off key  a reset key 204  a gyro-sensor and an accelerometer 205 and a volume controlling means 206. The 3-axis gyro-sensor 205 provides data relative to the patient’s head orientation  at any moment  relative to gravity  and in certain instances relative to geographical direction  wherein the data may be acquired from previous maneuvers  responses and data from the current session  or a prior session. Further  the data provide by these devices are passed to the BPPV processor 207  which analyzes the input data and compares the data with Epley’s maneuver and gives feedback for performing the maneuver with precision. The feedback is provided in audio format and is transmitted to the output devices such as ear plug 209  speaker 210  beeper 211  a visual display means (a monitor/screen  a single light  a sequence of lights and so on) and the like. The audio output devices deliver the audio files as voice output to the user. The user may be the patient suffering from an attack of BPPV or may be a person performing the Epley’s maneuver on a patient suffering from BPPV. There may be a battery 212 present  which supplies power to the various modules present in the apparatus.
[0036] In another embodiment herein  the apparatus  as described herein  may comprise another means which enables the apparatus to communicate with remote servers and/or individuals. The communication means may be via the internet or via a cellular communication network. The apparatus may communicate with a computer/tablet/PDA using a suitable means such as Wi-Fi  Bluetooth or any other suitable means. The computer/tablet/PDA may be provided with a communication means to transfer the data sent from the apparatus via the internet or any other suitable means to a server. The computer/tablet/PDA may also store the data within a locally located storage area. The apparatus may also include functionalities of a User Equipment (UE) within it  wherein the apparatus may initiate a call at pre-defined intervals  on request or when the device is in use. The apparatus may send information to the server whenever the device is in use  at pre-defined intervals (defined by the patient  operator or any other entity) or manually/remotely triggered when required. The data sent by the apparatus comprises of number of attempts made to treat a patient  number of successful attempts made to treat a patient  number of unsuccessful attempts made to treat a patient  number of incomplete attempts  information related to each step within the treatment process and so on. The data may also comprise location information of the apparatus (obtained using a suitable means) and any other relevant information. The server may store the data in a suitable storage and make the data available to authorized stake holders (physicians  insurance staff  support staff and so on). The server may also transfer the data in a pre-specified web based location such as Microsoft Health Vault  EHR  Dossia  World Medical Card and so on  in an account associated with the patient and the patient has authorized the server to access his account and store data in the account. The server may also transfer the data to a physical device (such as a computer  PDA  phone and so on)  as instructed by the patient.
[0037] FIG. 3 is a block diagram illustrating the BPPV processor  according to embodiments as disclosed herein. The BPPV processor 207 comprises of a gyro-processor 301  a maneuver management module 302  a controller 304  a battery management module 303  a memory 305  an input interface 306 and an audio output means 307 (such as a speaker  alarm  headphone and so on). The input interface 306 receives the data from the user interface present on the apparatus (such as buttons  keys and so on). The input interface 306 identifies the type of input received and instructs the controller 304 to perform the function corresponding to that specific key. For example  when a switch on button is pressed by a user  the input interface 306 processes the same and instructs the controller 304 to turn the apparatus on. The gyro-processor 301 receives the data from the 3 axis gyro-sensor and processes the data. Further  these data may be transferred to the Maneuver management module 302 via the controller 304  where the Maneuver management module 302 may utilize this data and may compute the nature of the current movement and the time the current movement is being performed. The Maneuver management module 302 may then provide the controller 304 with further instructions. The controller 304 may provide feedback via the output means for further performing the maneuver with precision. This feedback may use an appropriate audio file selected by the controller 304 from the memory 305.
[0038] FIGs. 4a and 4b are flowcharts illustrating the process of BPPV treatment  according to embodiments as disclosed herein. On detecting a patient suffering from BPPV  the patient himself and/or an observer may position the device on the patient and switch ON (401) the device. The device may be switched ON using the power on/off key 202. The device provides (402) instructions’ regarding the initial positioning of the patient and the patient is placed (403) in the position. The initial position of the patient may be laying down on a flat surface (such as a bed  couch  table  ground and so on) or in a chair with the head slightly forward; so that the tragal-canthal line is oriented horizontally for calibration purposes resulting in the plane of the horizontal semicircular canals being placed in relation to the pitch plane. The device further gives (404) instructions regarding the next position of the patient. The device then detects (405) the orientation of the head of the patient. The orientation may be determined by factors such as rotation (AOR)  fast phase direction (FPD)  slow phase velocity of the patient’s head and so on. The device then performs (406) a check if the detected orientation is the correct orientation  according to the Epleys’ maneuver. If the device detects that the orientation of the head of the patient is wrong  then the device provides (407) appropriate instructions to the patient and/or observer. The instructions may be in the form of corrections to be made to the current orientation of the head of the patient or may be instructions repeated regarding the expected orientation. If the orientation of the head of the patient is correct  then the device determines (408) the time the head of the patient has been placed in that position and checks (409) if the determined time exceeds a defined holding time for that position. If the determined time exceeds the defined holding time  then the device may provide (410) a confirmation to the patient and/or observer. The confirmation may be in the form of an auditory message (a beep  an audio message and so on)  a visual message (a message on the display  a single light or a sequence of lights and so on) or a combination of audio and visual messages. The device then checks (411) if the Epleys’ procedure is complete. If the procedure is complete  the device may give (413) a procedure complete indication to the patient and/or observer and exits (414). The confirmation may be in the form of an auditory message (a beep  an audio message and so on)  a visual message (a message on the display  a single light or a sequence of lights and so on) or a combination of audio and visual messages. The device may exit by switching itself off or by sending a message to the patient and/or observer. The switching off message may be in the form of an auditory message (a beep  an audio message and so on)  a visual message (a message on the display  a single light or a sequence of lights and so on) or a combination of audio and visual messages. If the device detects that the procedure is not complete  the device determines (412) the next step and proceeds to repeat from step 404. The various actions in the method 400 can be performed in the order presented  in a different order or simultaneously. Further  in some embodiments  some actions listed in FIG. 4 can be omitted.
[0039] The embodiments disclosed herein can be implemented through at least one software program running on at least one hardware device and performing network management functions to control the network elements. The network elements shown in Figs. 2 and 3 include blocks which can be at least one of a hardware device  or a combination of hardware device and software module.
[0040] The embodiment disclosed herein provide methods and systems to enable customization of an application to enhance user experience on a computing device by having one or more resident client entities negotiate with one or more client execution entities or a server on aspects of said application that can be customized. Therefore  it is understood that the scope of the protection is extended to such a program and in addition to a computer readable means having a message therein  such computer readable storage means contain program code means for implementation of one or more steps of the method  when the program runs on a server or portable device or any suitable programmable device. The method is implemented in a preferred embodiment through or together with a software program written in e.g. Very high speed integrated circuit Hardware Description Language (VHDL) another programming language  or implemented by one or more VHDL or several software modules being executed on at least one hardware device. The hardware device can be any kind of portable device that can be programmed. The device can also include means which could be e.g. hardware means like e.g. an ASIC  or a combination of hardware and software means  e.g. an ASIC and an FPGA  or at least one microprocessor and at least one memory with software modules located therein. The method embodiments described herein could be implemented partly in hardware and partly in software. Alternatively  the invention can be implemented on different hardware devices  e.g. using a plurality of CPUs.
[0041] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can  by applying current knowledge  readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept  and  therefore  such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore  while the embodiments herein have been described in terms of preferred embodiments  those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

CLAIMS
We claim 
1. An apparatus for treating Benign Paroxysmal Positional Vertigo (BPPV) in a patient  said apparatus comprising at least one means configured for
Detecting position of head of said patient  when performing Epleys’ maneuver on said patient; and
Providing audio instructions  based on position of head of said patient and time said position of head of said patient has been held.
2. The apparatus  as claimed in claim 1  wherein said apparatus may be operated by at least one of
Said patient;
A medically trained person; or
A lay person.
3. The apparatus  as claimed in claim 1  wherein said apparatus comprises of a gyro sensor; and an accelerometer.
4. The apparatus  as claimed in claim 1  wherein said apparatus further comprises a means configured for providing said audio instructions  wherein said audio instructions comprises of at least one of
Instructions regarding next step to be performed;
Instructions regarding step to be re-performed;
Instructions regarding correction to position of head of said patient to reach correct position of head of said patient; or
Time for which each of said positions need to be held.
5. The apparatus  as claimed in claim 1  wherein said apparatus further comprises of a means for resetting said device.
6. The apparatus  as claimed in claim 1  wherein said apparatus further comprises of a means for transferring data to at least one remote location.
7. A method for treating Benign Paroxysmal Positional Vertigo (BPPV) in a patient using an apparatus  said method comprising of
Detecting position of head of said patient  when performing Epleys’ maneuver on said patient; and
Providing audio instructions  based on position of head of said patient and time said position of head of said patient has been held.
8. The method  as claimed in claim 7  wherein said apparatus may be operated by at least one of
Said patient;
A medically trained person; or
A lay person.
9. The method  as claimed in claim 7  wherein said audio instructions comprises of at least one of
Instructions regarding next step to be performed;
Instructions regarding step to be re-performed;
Instructions regarding correction to position of head of said patient to reach correct position of head of said patient; or
Time for which each of said positions need to be held.
10. The method  as claimed in claim 7  wherein said method comprises of transferring data from said apparatus to at least one remote location.
11. The method  as claimed in claim 7  wherein said method comprises of providing said data to at least one stake holder.
12. The method  as claimed in claim 7  wherein said method comprises of storing said data in at least one of
a web based location; or
a physical device.

Dated: 6th December 2011 Dr Kalyan Chakravarthy
(Patent agent)
ABSTRACT
System and method for automated treatment of Benign paroxysmal positional vertigo (BPPV) is disclosed. The present invention relates to a medical device. More specifically  it relates to devices for the treatment of vestibular disorders involving symptoms of dizziness  vertigo and/or imbalance. Currently  the BPPV disorder can be treated by singular neurectomy and posterior semi-circular canal occlusion are highly effective surgical procedures. Further  there as some non-surgical repositioning methods available. However  these non-surgical methods are not effective and these methods require physician’s assistance. The present invention enables automated treatment of BPPV by utilizing 3-axis Gyro-sensor. The apparatus can be used by the patient without anybody’s assistance. The users can save money and time by utilizing the present invention and yet  achieve high precision with the maneuver.

FIG. 1