CLIAMS:We claim:
1. A closed loop method for simulating motility of gut of a patient, the method comprising of applying stimulus to dorsal nucleus of vagal nerve by an Intra-Ventricular Unit, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
2. The method, as claimed in claim 1, wherein the method further comprises of
monitoring motility of the gut by an abdominal unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit based on the motility of the gut.
3. The method, as claimed in claim 2, wherein the abdominal unit monitors motility of the gut using at least one EGEG (Electro-Gastro- Entero Graphy) electrode.
4. The method, as claimed in claim 2, wherein the abdominal unit communicates with the Intra-Ventricular Unit using wireless communication.
5. The method, as claimed in claim 5, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
6. The method, as claimed in claim 2, wherein the method of calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve comprises
converting measured motility of the gut into electrical activity by at least one of the abdominal unit; or the Intra-Ventricular Unit;
comparing the electrical activity with a pre-defined electrical activity threshold by at least one of the abdominal unit; or the Intra-Ventricular Unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit, if the electrical activity is below the pre-defined electrical activity threshold.
7. The method, as claimed in claim 6, wherein the method further comprises of comparing the stimulus to a pre-defined stimulus threshold.
8. A closed loop system for simulating motility of gut of a patient comprising of an abdominal unit and an Intra-Ventricular Unit, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
9. The system, as claimed in claim 8, wherein the abdominal unit is configured to communicate with the Intra-Ventricular Unit using wireless communication.
10. The system, as claimed in claim 8, wherein the system further comprises of
monitoring motility of the gut by the abdominal unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit based on the motility of the gut.
11. The system, as claimed in claim 10, wherein the abdominal unit is configured for monitoring motility of the gut using at least one EGEG (Electro-Gastro- Entero Graphy) electrode.
12. The system, as claimed in claim 12, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
13. The system, as claimed in claim 10, wherein the system is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by
converting measured motility of the gut into electrical activity by at least one of the abdominal unit; or the Intra-Ventricular Unit;
comparing the electrical activity with a pre-defined electrical activity threshold by at least one of the abdominal unit; or the Intra-Ventricular Unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit, if the electrical activity is below the pre-defined electrical activity threshold.
14. The system, as claimed in claim 13, wherein the system is further configured for comparing the stimulus to a pre-defined stimulus threshold.
15. An Intra-Ventricular Unit, wherein said Intra-Ventricular Unit is present in a closed loop system for simulating motility of gut of a patient, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
16. The Intra-Ventricular Unit, as claimed in claim 15, wherein the Intra-Ventricular Unit is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve based on the motility of the gut.
17. The Intra-Ventricular Unit, as claimed in claim 16, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
18. The Intra-Ventricular Unit, as claimed in claim 16, wherein the Intra-Ventricular Unit is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by
converting measured motility of the gut into electrical activity;
comparing the electrical activity with a pre-defined electrical activity threshold; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve, if the electrical activity is below the pre-defined electrical activity threshold.
19. The Intra-Ventricular Unit, as claimed in claim 18, wherein the Intra-Ventricular Unit is further configured for comparing the stimulus to a pre-defined stimulus threshold.
20. The Intra-Ventricular Unit, as claimed in claim 15, wherein the Intra-Ventricular Unit is configured to communicate with an abdominal unit using wireless communication.

Date: 27th day of January, 2014 Signature:

Vikram Pratap Singh Thakur

Patent Agent
,TagSPECI: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

“Closed loop stimulation of the dorsal nucleus of the vagus nerve”

APPLICANT:

Name : HCL Technologies Limited

Nationality : Indian

Address : HCL Technologies Ltd
AMB 3.64-66,South Phase,II Main road,
Ambattur Industrial estate,Chennai-58

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] This invention relates to medical devices, and more particularly to a method and systems for closed loop stimulation of the dorsal nucleus of the vagus nerve at the floor of the fourth ventricle.

BACKGROUND OF INVENTION
[002] Disorders such as obesity, paralytic ileus and other disorders related to the gut are increasingly common due to the sedentary lifestyles.
[003] Obesity can be caused by environmental, genetic or mixed conditions. In patients with genetic causes of obesity, there are metabolic derangements which lead to abnormal accumulation of lipids in the body. Environmental factors can be physical or chemical exposure, socio economic conditions including eating high calorie food etc.
[004] For treating disorders such as obesity, medical and non-medical approaches have been adopted to enable the patient to lose weight. The non-medical approaches comprise of diet, exercise or a combination of diet and exercise. However, the non-medical approaches may not be permanent. On the diet and/or exercise being interrupted, the weight loss may be reversed and the patient may regain the lost weight.
[005] Also, anti-obesity medications like statins which interfere with fat absorption or activate the satiety centre may be used. These medications may not necessarily have the desired effect on the patient. However, these medications may cause side effects in the patient.
[006] The medical approaches comprise of surgeries like gastric bypass or gastric balloons, wherein the volume of the gut is reduced thereby reducing the absorption surface of the gut. This may result in a reduction in the weight of the patient. However, these approaches require invasive surgery to be performed, with the inherent risks associated with invasive surgery procedures.
[007] There are solutions, wherein the vagus nerve, which controls the movement of the alimentary canal, is simulated based on the movement of the gut, wherein the simulation is applied to the nerve in the chest cavity. However, this involves invasive surgery, as the apparatus required to monitor the gut has to be surgically placed in the gut and a connection means has to be provided to the point of simulation for the vagus nerve with the placement of electrodes in the chest cavity. Also, the solution is an open loop system, which may result in over treatment or under treatment of the patient. Also, the solution may result in side effects for the patient as the monitoring and simulating apparatus are located in the alimentary and chest cavity of the patient and any adjustments/defects in the apparatus may require further surgical procedures.

OBJECT OF INVENTION
[008] The principal object of this invention is to suggest a system and method to stimulate the dorsal nucleus of the vagus nerve to treat a variety of disease conditions/disorders related to motility of the gut.

STATEMENT OF INVENTION
[009] Accordingly the invention provides a closed loop method for simulating motility of gut of a patient, the method comprising of applying stimulus to dorsal nucleus of vagal nerve by an Intra-Ventricular Unit, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
[0010] Embodiments herein also provides a closed loop system for simulating motility of gut of a patient comprising of an abdominal unit and an Intra-Ventricular Unit, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
[0011] Also, provided herein is an Intra-Ventricular Unit, wherein said Intra-Ventricular Unit is present in a closed loop system for simulating motility of gut of a patient, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
[0012] 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
[0013] This invention is illustrated in the accompanying drawings, through out 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:
[0014] FIGs. 1 and 2 depict sections of the brains;
[0015] FIG. 3 depicts a system comprising of an Abdominal Unit (AU) and an Intra-Ventricular Unit (IVU) connected to a human body, according to embodiments as disclosed herein;
[0016] FIGs. 4a and 4b depict an Abdominal Unit (AU), according to embodiments as disclosed herein;
[0017] FIG. 5 depicts the placement of the Intra-Ventricular Unit (IVU), according to embodiments as disclosed herein;
[0018] FIGs. 6a and 6b depict an Intra-Ventricular Unit (IVU), according to embodiments as disclosed herein; and
[0019] FIG. 7 is a flowchart illustrating the process of the AU calculating the stimulus levels and communicating the stimulus levels to the IVU, according to embodiments as disclosed herein;
[0020] FIG. 8 is a flowchart illustrating the process of the AU communicating the electrical activity to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein;
[0021] FIG. 9 is a flowchart illustrating the process of the AU communicating the electrical activity to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein and
[0022] FIG. 10 is a flowchart illustrating the process of the AU communicating the electrical activity of the gut to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein.

DETAILED DESCRIPTION OF INVENTION
[0023] 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 may 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.
[0024] The embodiments herein disclose a system and method to stimulate the dorsal nucleus of the vagus nerve to treat a variety of disease conditions/disorders related to motility of the gut. Referring now to the drawings, and more particularly to FIGS. 1 through 10, where similar reference characters denote corresponding features consistently throughout the figures, there are shown preferred embodiments.
[0025] The vagus nerve is the 10th cranial nerve (among 12 cranial nerves) which innervates the heart, lung and the gastro intestinal tract and is a mixed nerve carrying both sensory and motor nerves to and from the medulla oblongata in the brain stem. The dorsal nucleus is the nucleus which gives the efferent fibers to the vagus nerve innervating the gastrointestinal tract. Hence the movement of the alimentary tract is controlled by the dorsal nucleus of the vagus nerve. The 4th ventricle is a cavity filled with cerebro-spinal fluid which nourishes the brain. The 4th ventricle is bound in the front by the brainstem (which houses the dorsal nucleus) and by cerebellum behind (as depicted in FIG. 1). The dorsal nucleus of the vagus nerve is present on the brainstem on the floor of the 4th ventricle. The dorsal nucleus extends from the floor of the 4th ventricle to the inside of the brainstem (as depicted in FIG. 2).
[0026] FIG. 3 depicts a system comprising of an Abdominal Unit (AU) and an Intra-Ventricular Unit (IVU) connected to a human body, according to embodiments as disclosed herein. The system depicts a system comprising of an Abdominal Unit (AU) 101 and an Intra-Ventricular Unit (IVU) 102.
[0027] The AU 101 may comprise of at least one EGEG (Electro-Gastro- Entero Graphy) electrode connected to the patient, in the vicinity of the abdominal cavity. The AU 101 may comprise of a plurality of EGEG electrodes connected to the patient, in the vicinity of the abdominal cavity. The AU 101 may be placed in a location on the patient, such that the EGEG electrodes may be secured in the appropriate locations in the vicinity of the abdominal cavity. The AU 101 is attached to the human body using at least one suitable means. The suitable means may be at least one strap (which may use at least one of Velcro, zips or any other suitable attaching means), a plurality of straps (which may use at least one of Velcro, zips or any other suitable attaching means), a Velcro strap, a plurality of Velcro straps and so on. The AU 101 may be worn above the clothes of the patient. The AU 101 may be worn below the clothes of the patient. The AU 101 may also be of a wearable nature.
[0028] The IVU 102 may be located on the floor of the 4th ventricle on top of the vagal triangle in the human brain cavity. The IVU 102 may be placed on the floor of the 4th ventricle on top of the vagal triangle using a surgical means. The surgical means may be an endoscopic means. The IVU 102 may be secured the floor of the 4th ventricle on top of the vagal triangle using a suitable means such as medically safe glue or any other equivalent means.
[0029] The AU 101 and the IVU 102 may be connected to each other using a wireless communication means. The wireless communication means may be a short range communication means such as Bluetooth, WiFi Direct, ZigBee and so on.
[0030] The AU 101 monitors the motility of the gut of the patient using the EGEG electrodes. The AU 101 converts signals received from the EGEG electrodes into a suitable form of measurable electrical activity. The signals measured by the EGEG electrodes may be proportional to the motility of the gut. The measurable electrical activity may be at least one of voltage and/or current. The AU 101 checks if the level of the electrical activity is below a pre-defined electrical activity threshold. The pre-defined electrical activity threshold may be defined by at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined electrical activity threshold). The pre-defined electrical activity threshold may determine the level of rhythmic movement of the gut.
[0031] If the electrical activity is below the pre-defined electrical activity threshold, the AU 101 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below a pre-defined stimulus threshold, wherein the pre-defined stimulus threshold may be defined by at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined stimulus threshold). The AU 101 may communicate the level of stimulus to the IVU 102. The IVU 102 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode.
[0032] In an embodiment herein, the AU 101 may send the electrical activity to the IVU 102. The IVU 102 may check if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the IVU 102 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode.
[0033] In an embodiment herein, the AU 101 may check if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the AU 101 may send the level of electrical activity to the IVU 102 and the IVU 102 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode.
[0034] In an embodiment herein, the AU 101 may send the signals received from the EGEG electrodes to the IVU 102. The IVU 102 converts the signals into a suitable form of measurable electrical activity, wherein the measurable electrical activity may be at least one of voltage and/or current. The IVU 102 checks if the level of the electrical activity is below the pre-defined electrical activity threshold. The IVU 102 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode.
[0035] On the IVU 102 applying the stimulus to the dorsal nucleus of the vagus nerve, the motility of the gut varies. The EGEG electrodes measure the varied motility of the gut and sends appropriate signals to the AU 101. The simulation applied to the dorsal nucleus of the vagus nerve may be modified based on the varied motility of the gut.
[0036] FIGs. 4a and 4b depict an Abdominal Unit (AU), according to embodiments as disclosed herein. The AU 101, as depicted comprises of an AU processor 401, at least one EGEG electrode 402 and a communication interface 403 (as depicted in FIG. 4a). The AU 101, as depicted comprises of at least one EGEG electrode 402 and a communication interface 403 (as depicted in FIG. 4b).
[0037] The communication interface 403 may use a wireless means to communicate with the IVU 102. The wireless means may be a short range communication means such as Bluetooth, WiFi Direct, ZigBee and so on.
[0038] The AU 101 may also comprise of an interface, which will enable at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner) to turn the AU 101 ON/OFF. The interface may be a physical switch (such as a push button switch, a toggle switch, a soft touch button, a press button and so on). The interface may also be a graphical user interface, which enables at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner) to turn the AU 101 ON/OFF.
[0039] The AU 101 may comprise of a configuration interface which will enable at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner) to configure the device, wherein the configuration may comprise of setting the simulation level threshold, modifying the simulation level threshold, setting the electrical activity threshold, modifying the electrical activity threshold and so on. The configuration interface may be a port which will enable at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner) to connect to the AU 101, a Graphical User Interface (GUI) or any other suitable means. The port may enable connection of a device such as a computer, a laptop, a tablet, a mobile device or any other device capable of enabling at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner) to view the current configuration of the AU 101, set parameters and configure the parameters at a suitable time.
[0040] The EGEG electrodes 402 measure the movements of the guts and pass the information about the movement of the gut (as raw signals) to the AU processor 401. The AU processor 401 converts the signals received from the EGEG electrodes into a suitable form of measurable electrical activity, wherein the measurable electrical activity may be at least one of voltage and/or current. The AU processor 401 checks if the level of the electrical activity is below the pre-defined electrical activity threshold. The AU processor 401 enables at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined electrical activity threshold) to define the pre-defined electrical activity threshold. The pre-defined electrical activity threshold may determine the level of rhythmic movement of the gut.
[0041] If the electrical activity is below the pre-defined electrical activity threshold, the AU processor 401 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold, wherein the AU processor 401 enables at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined stimulus threshold) to define the pre-defined stimulus threshold. The AU processor 401 may communicate the level of stimulus to the IVU 102 using the communication interface 403.
[0042] In an embodiment herein, the AU processor 401 may send the electrical activity to the IVU 102 using the communication interface 403.
[0043] In an embodiment herein, the AU processor 401 may check if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the AU processor 401 may send the level of electrical activity to the IVU 102, through the communication interface 403.
[0044] In an embodiment herein, the EGEG electrodes 402 may send the signals to the IVU 102 using the communication interface 403.
[0045] FIG. 5 depicts the placement of the Intra-Ventricular Unit (IVU), according to embodiments as disclosed herein. The IVU 102 may be implanted on the floor of the 4th ventricle on top of the vagal triangle. The IVU 102 may be placed on the floor of the 4th ventricle on top of the vagal triangle using a surgical means. The surgical means may be an endoscopic means. The IVU 102 may be secured the floor of the 4th ventricle on top of the vagal triangle using a suitable means such as medically safe glue or any other equivalent means. The IVU 102 may be placed in contact with the dorsal nucleus of the vagus nerve, wherein at least one simulation electrode of the IVU may be place in contact with the dorsal nucleus of the vagus nerve.
[0046] FIGs. 6a and 6b depict an Intra-Ventricular Unit (IVU), according to embodiments as disclosed herein. The IVU 102, as depicted comprises of an IVU processor 601, at least one simulation electrode 602 and a communication interface 603 (as depicted in FIG. 6a). The IVU 102, as depicted comprises of at least one simulation electrode 602 and a communication interface 603 (as depicted in FIG. 6b).
[0047] The communication interface 603 may use a wireless means to communicate with the AU 101. The wireless means may be a short range communication means such as Bluetooth, WiFi Direct, ZigBee and so on.
[0048] The AU 101 sends the signals from the EGEG electrodes to the IVU processor 601, through the communication interface 603. The IVU processor 601 converts signals received from the EGEG electrodes into a suitable form of measurable electrical activity. The signals measured by the EGEG electrodes may be proportional to the motility of the gut. The measurable electrical activity may be at least one of voltage and/or current. The IVU processor 601 checks if the level of the electrical activity is below the pre-defined electrical activity threshold. The pre-defined electrical activity threshold may be defined by at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined electrical activity threshold). The pre-defined electrical activity threshold may determine the level of rhythmic movement of the gut.
[0049] If the electrical activity is below the pre-defined electrical activity threshold, the IVU processor 601 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold, wherein the pre-defined stimulus threshold may be defined by at least one of an authorized medical practitioner associated with the patient, the patient or an authorized person (wherein the authorized person may be authorized by the patient and/or the medical practitioner to set the pre-defined stimulus threshold). The IVU processor 601 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using the at least one simulation electrode 602.
[0050] In an embodiment herein, the IVU processor 601 may receive the electrical activity from the AU 101, through the communication interface 603. The IVU 102 may check if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the IVU processor 601 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU processor 601 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using the at least one simulation electrode 602.
[0051] In an embodiment herein, the IVU processor 601 receives the level of electrical activity from the AU 101 and the IVU processor 601 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU processor 601 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode 602.
[0052] In an embodiment herein, the IVU processor 601 may receive the signals received from the EGEG electrodes, through the communication interface 603. The IVU processor 601 converts the signals into a suitable form of measurable electrical activity, wherein the measurable electrical activity may be at least one of voltage and/or current. The IVU processor 601 checks if the level of the electrical activity is below the pre-defined electrical activity threshold. The IVU processor 601 may calculate the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU processor 601 then may apply the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode.
[0053] FIG. 7 is a flowchart illustrating the process of the AU calculating the stimulus levels and communicating the stimulus levels to the IVU, according to embodiments as disclosed herein. The AU 101 monitors (701) the motility of the gut of the patient using the EGEG electrodes. The AU 101 converts (702) signals received from the EGEG electrodes into a suitable form of measurable electrical activity. The signals measured by the EGEG electrodes may be proportional to the motility of the gut. The measurable electrical activity may be at least one of voltage and/or current. The AU 101 checks (703) if the level of the electrical activity is below the pre-defined electrical activity threshold. If the electrical activity is below the pre-defined electrical activity threshold, the AU 101 calculates (704) the level of stimulus to be applied to the dorsal nucleus of the vagus nerve, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The AU 101 communicates (705) the level of stimulus to the IVU 102. The IVU 102 applies (706) the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode and the motility of the gut varies (707) based on the simulation. The various actions in method 700 may be performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some actions listed in FIG. 7 may be omitted.
[0054] FIG. 8 is a flowchart illustrating the process of the AU communicating the electrical activity to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein. The AU 101 monitors (801) the motility of the gut of the patient using the EGEG electrodes. The AU 101 converts (802) signals received from the EGEG electrodes into a suitable form of measurable electrical activity. The AU 101 sends (803) the electrical activity to the IVU 102. The IVU 102 checks (804) if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the IVU 102 calculates (805) the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 then applies (806) the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode and the motility of the gut varies (807) based on the simulation. The various actions in method 800 may be performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some actions listed in FIG. 8 may be omitted.
[0055] FIG. 9 is a flowchart illustrating the process of the AU communicating the electrical activity to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein. The AU 101 monitors (901) the motility of the gut of the patient using the EGEG electrodes. The AU 101 converts (902) signals received from the EGEG electrodes into a suitable form of measurable electrical activity. The AU 101 checks (903) if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the AU 101 sends (904) the electrical activity to the IVU 102. The IVU 102 calculates (905) the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity as communicated by the AU 101, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 then applies (906) the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode and the motility of the gut varies (907) based on the simulation. The various actions in method 900 may be performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some actions listed in FIG. 9 may be omitted.
[0056] FIG. 10 is a flowchart illustrating the process of the AU communicating the electrical activity of the gut to the IVU and the IVU calculating the stimulus levels, according to embodiments as disclosed herein. The AU 101 monitors (1001) the motility of the gut of the patient using the EGEG electrodes. The AU 101 sends (1002) the signals received from the EGEG electrodes to the IVU 102. The IVU 102 converts (1003) the signals into a suitable form of measurable electrical activity, wherein the measurable electrical activity may be at least one of voltage and/or current. The IVU 102 checks (1004) if the level of the electrical activity is below the pre-defined electrical activity threshold. If the level of the electrical activity is below the pre-defined electrical activity threshold, the IVU 102 calculates (1005) the level of stimulus to be applied to the dorsal nucleus of the vagus nerve based on the electrical activity, wherein the level of stimulus may be in the form of at least one of current and/or voltage and the frequency of application of the stimulus. The current and/or voltage to be applied as stimulus may be below the pre-defined stimulus threshold. The IVU 102 applies (1006) the level of stimulus to the dorsal nucleus of the vagus nerve using at least one simulation electrode and the motility of the gut varies (1007) based on the simulation. The various actions in method 1000 may be performed in the order presented, in a different order or simultaneously. Further, in some embodiments, some actions listed in FIG. 10 may be omitted.
[0057] Embodiments disclosed herein enable implantation of the IVU 102 via a minimally invasive surgery (as the 4th ventricle can be accessed endoscopically) as compared to conventional surgeries like gastric bypass. This is beneficial to the patients and aids in a faster recovery post surgically.
[0058] Embodiments disclosed herein reduce the absorption of the intake of a patient in the gut by reducing the time of passage through the gut.
[0059] Embodiments disclosed herein disclose stimulation of the dorsal nucleus at the floor of the 4th ventricle to improve the motility of the gut, an improved motility of the gut can be used as a treatment for obesity, paralytic ileus or any other disease/disorder which affects the motility of the gut.
[0060] Embodiments herein disclose a closed loop mechanism which will not need regular human intervention to function.
[0061] Embodiments herein prevent side effects by directly simulating the dorsal nucleus of the vagus nerve.
[0062] 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. 3, 4a, 4b, 6a and 6b include blocks which can be at least one of a hardware device, or a combination of hardware device and software module.
[0063] The embodiment disclosed herein describes a system and method to stimulate the dorsal nucleus of the vagus nerve to treat a variety of disease conditions/disorders related to motility of the gut. 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 mobile 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 may 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 may be implemented on different hardware devices, e.g. using a plurality of CPUs.
[0064] 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. A closed loop method for simulating motility of gut of a patient, the method comprising of applying stimulus to dorsal nucleus of vagal nerve by an Intra-Ventricular Unit, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
2. The method, as claimed in claim 1, wherein the method further comprises of
monitoring motility of the gut by an abdominal unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit based on the motility of the gut.
3. The method, as claimed in claim 2, wherein the abdominal unit monitors motility of the gut using at least one EGEG (Electro-Gastro- Entero Graphy) electrode.
4. The method, as claimed in claim 2, wherein the abdominal unit communicates with the Intra-Ventricular Unit using wireless communication.
5. The method, as claimed in claim 5, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
6. The method, as claimed in claim 2, wherein the method of calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve comprises
converting measured motility of the gut into electrical activity by at least one of the abdominal unit; or the Intra-Ventricular Unit;
comparing the electrical activity with a pre-defined electrical activity threshold by at least one of the abdominal unit; or the Intra-Ventricular Unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit, if the electrical activity is below the pre-defined electrical activity threshold.
7. The method, as claimed in claim 6, wherein the method further comprises of comparing the stimulus to a pre-defined stimulus threshold.
8. A closed loop system for simulating motility of gut of a patient comprising of an abdominal unit and an Intra-Ventricular Unit, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
9. The system, as claimed in claim 8, wherein the abdominal unit is configured to communicate with the Intra-Ventricular Unit using wireless communication.
10. The system, as claimed in claim 8, wherein the system further comprises of
monitoring motility of the gut by the abdominal unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit based on the motility of the gut.
11. The system, as claimed in claim 10, wherein the abdominal unit is configured for monitoring motility of the gut using at least one EGEG (Electro-Gastro- Entero Graphy) electrode.
12. The system, as claimed in claim 12, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
13. The system, as claimed in claim 10, wherein the system is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by
converting measured motility of the gut into electrical activity by at least one of the abdominal unit; or the Intra-Ventricular Unit;
comparing the electrical activity with a pre-defined electrical activity threshold by at least one of the abdominal unit; or the Intra-Ventricular Unit; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by at least one of the abdominal unit; or the Intra-Ventricular Unit, if the electrical activity is below the pre-defined electrical activity threshold.
14. The system, as claimed in claim 13, wherein the system is further configured for comparing the stimulus to a pre-defined stimulus threshold.
15. An Intra-Ventricular Unit, wherein said Intra-Ventricular Unit is present in a closed loop system for simulating motility of gut of a patient, the Intra-Ventricular Unit configured for applying stimulus to dorsal nucleus of vagal nerve, wherein the Intra-Ventricular Unit is located on floor of 4th ventricle on top of vagal triangle.
16. The Intra-Ventricular Unit, as claimed in claim 15, wherein the Intra-Ventricular Unit is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve based on the motility of the gut.
17. The Intra-Ventricular Unit, as claimed in claim 16, wherein the stimulus comprises at least one of current and/or voltage and frequency of application of the stimulus.
18. The Intra-Ventricular Unit, as claimed in claim 16, wherein the Intra-Ventricular Unit is further configured for calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve by
converting measured motility of the gut into electrical activity;
comparing the electrical activity with a pre-defined electrical activity threshold; and
calculating the stimulus to be applied to the dorsal nucleus of the vagal nerve, if the electrical activity is below the pre-defined electrical activity threshold.
19. The Intra-Ventricular Unit, as claimed in claim 18, wherein the Intra-Ventricular Unit is further configured for comparing the stimulus to a pre-defined stimulus threshold.
20. The Intra-Ventricular Unit, as claimed in claim 15, wherein the Intra-Ventricular Unit is configured to communicate with an abdominal unit using wireless communication.

Date: 27th day of January, 2014 Signature:

Vikram Pratap Singh Thakur

Patent Agent

ABSTRACT
Closed loop stimulation of the dorsal nucleus of the vagus nerve. This invention relates to medical devices, and more particularly to a method and systems for closed loop stimulation of the dorsal nucleus of the vagus nerve at the floor of the fourth ventricle. The principal object of this invention is to suggest a system and method to stimulate the dorsal nucleus of the vagus nerve to treat a variety of disease conditions/disorders related to motility of the gut.
FIG. 3