FORM 2
The Patents Act 1970
(39 of 1970)
&
The Patent Rules 2003
COMPLETE SPECIFICATION
(See Section 10 and rule 13)
TITLE OF THE INVENTION:
INNOVATIVE ADDITIONS (INVENTIONS) IN
ELECTRO-CHEMOTHERAPY DEVICE
FOR TREATING CANCER TUMOURS
APPLICANT:
a) Name: Tenon Meditech LLP
b) Nationality: Indian
c) Address: Flat No. 11, Bhaktiyog Building, S. No. 123/A/1, off Paud Road, Kothrud, Pune - 411038
PREAMBLE OF THE DESCRIPTION:
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE THE INVENTIONS INTRODUCED IN THE ELECTRO-CHEMOTHERAPY DEVICE AND THE MANNER IN WHICH THEY ARE PERFORMED

A) TECHNICAL FIELD
(001) The present invention generally relates to a medical device and particularly
relates to certain innovative features (inventions) in the electro-chemotherapy
device. Electro-chemotherapy is used to treat cutaneous and sub cutaneous cancer
tumours. The electro-chemotherapy device uses high voltage short duration electric
impulses for local treatment (treatment at tumour site) of cancer tumours. The
treatment delivers tumour regression (partial/total) and control on tumour pain,
tumour bleeding and tumour secretions.
B) BACKGROUND OF INVENTION
(2) The World Cancer Report by WHO mentions “a cancer burden of 1.6 million new cancer cases in India in 2018.” India has a large number of late detection cancer cases, especially in head and neck cancers, which are rampant in the socially and economically backward strata of the society due to tobacco chewing. Head and Neck cancers account for nearly 30% of all cancers in India. 50% of these are late detection cases. These late detection cutaneous and sub-cutaneous head and neck cancer tumours (tumours on the skin or just below the skin) pose major challenges during treatment due to their size and location. They are often unresectable and also don’t respond to regular chemotherapy and radiotherapy. The location of oral cavity cancer tumours is even more precarious in terms of access. Besides this, there are a large number of recurring cutaneous and sub-cutaneous skin metastasis which pose treatment difficulties with the present standard of care. i.e . surgery, usual chemotherapy and radiotherapy. Similar problems exist with other cancer tumours including breast cancer tumours and skin cancers tumours.
(3) These tumours are present in curative as well as palliative cases. They have a very serious impact on the patient’s quality of life. These tumours bleed and give

out secretions. They are extremely painful, which gets unbearable for the patient. Painkillers are often ineffective in stopping or even blunting this pain. It is very difficult, or often not even possible, to operate large tumours on the face, neck or those inside the mouth due to their precarious location and size. These tumours can block essential functions like breathing, swallowing, eating, speaking etc. In case of recurring tumours, even if they respond to treatment in the initial stages, recurrent and frequent treatment through surgery, traditional chemotherapy and radiotherapy may not be feasible and can even be harmful to the patient beyond a point.
(4) Chemotherapy relates to the use of medicines to treat cancer. One of the biggest hurdles in chemotherapy is the very low permeability of the cell-membrane. It restricts the entry of the chemotherapeutic drug into cells of the cancer tumour. The problem is addressed by delivering large quantity of chemotherapeutic drug. This approach has major side-effects. Also, in certain tumours, this technique fails to deliver much impact. Low or no uptake of chemotherapeutic drugs by cancer tumour cells can occur despite injection of large quantity of the drug. Chemotherapeutic drugs cannot be injected in unlimited quantity. Beyond a limit, they are harmful for the patient.
(5) Electro-chemotherapy is a more effective method to deliver the chemotherapy drug into the cancer tumour, when the tumour is not responding to regular chemotherapy or radiation.
(6) Electro-chemotherapy is a combination of reversible electroporation and low dose chemotherapy. Reversible electroporation is achieved with short duration high voltage electric impulses. Reversible electroporation changes permeability of cancer cell membrane to allow higher uptake of chemotherapy drugs.
(7) An electro-chemotherapy device is used for electroporation. Electroporation is done at tumour site with the help of an applicator with connected electrodes. The applicator is attached to an impulse generator. Impulses generated by the impulse

generator reach the tumour with the help of the applicator and electrodes. This changes cell membrane permeability of cells in the cancer tumour. Increased permeability increases drug uptake by several fold. Chemotherapy has to administered separately and is not a part of the functions of the electro-chemotherapy device.
(8) Existing electro-chemotherapy devices are few and expensive. They are not designed for Indian conditions. The existing devices available in India do not have any special arrangement for oral cavity cancer tumours (which are a part of head and neck cancer tumours.) Oral cancers form a large section in head and neck cancer tumours.
(9) Another limitation of the existing devices is the absence of imaging. It is difficult to access therapy impact without photographs or imaging. Scanning is not an affordable option in India and photographs taken independently on the mobile don’t get stored in the relevant treatment records.
(10) In case of the current electro-chemotherapy devices, treatment records are not generated in the system; and hence documentation of treatment details is not precise and organised.
(11) The electro-chemotherapy devices available in the Indian market are not Made in India and not designed for Indian conditions. Our invention is addressing the Indian needs with India oriented innovations.
(012) The aforesaid shortcomings, disadvantages and problems are addressed
herein, by the inventive features in our new electro-chemotherapy device. The
inventive features also deliver extra safety for the patient and the doctor as well as
the device operator.

C) OBJECT OF INVENTION
(13) - There are four areas in which we have invented novel features to the electro-chemotherapy device.
(14) - The first novel feature has an objective to access oral cancer tumours with ease. Our invention is a 2 pin applicator. This is a special applicator for accessing tumours inside the mouth, especially those at the base of the tongue. This 2 pin applicator has a slim front portion with just two electrodes attached instead of the normal 4. This facilitates its entry through a small mouth opening and ensures good reach and maneuverability inside the mouth. Mouth openings in head and neck cancer patients can be narrow due to tumours. This applicator has been specially designed to respond to Indian needs where percentage of oral cancers is high.
(15) - The second novel feature has an objective to provide additional safety through voltage output control while delivering the electric impulses. Our invention ensures that voltage of the current delivered by the device does not exceed the accepted range by providing for output voltage control.
(16) The third novel feature is to capture, store, integrate and display structured and unstructured data. A camera captures images (unstructured data). Structured data such as patient details and treatment details is captured by interactive user interface through a custom made software application. This provides useful information to the doctor about the tumour and the treatment, which helps in decision making regarding the further course of treatment. Integration, storage and display of structured and unstructured data gives the doctor a complete picture. The

images are crucial for assessing therapy impact after the procedure. Scanning facility is often expensive and has health risks. Camera images can give the surgeon a good ‘before and after’ comparison in cutaneous tumours and also in sub¬cutaneous tumours which show an exterior bump on the skin. The access to this information is very organised due to integration of patient and treatment information and tumour images.
(17) - The fourth novel feature is an automatic system generated report and a system mounted printer. The objective of this invention is to create an automatic report document inside the system and give a facility to print the same. This report gives an authentic and automatic report without any manual intervention. This report can be kept with the doctor/hospital as well as given to the patient to maintain a precise record.
(18) - These and other objectives and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying documents.
D) SUMMARY OF INVENTION
(19) Our invention is in the nature of novel features to an electro-chemotherapy device.
(20) Our first novel inventive feature provides for a narrow mouth

2 pin applicator for accessing oral cavity cancers. The second novel feature provides additional safety to the user and patient by providing output voltage control. The third novel inventive feature provides the capture, integration and display of structured and unstructured data through a software programme and an attached camera. Camera captures tumour images which are integrated into the structured data captured by the software application. The fourth novel feature is an automatic system generated report and a mounted printer provided to print it for documentation.
E) BRIEF DESCRIPTION OF DOCUMENTS (DRAWINGS/ ILLUSTRATIONS)
(21) - All the objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying documents as follows:
(22) SHEET 1: DEVICE WITH COMPONENTS
FIG. illustrates a total external view of our elector-chemotherapy device, along with all its components, including the novel inventive features, according to one embodiment of the present invention.
(023) SHEET. 2: A NOVEL 2-PIN APPILCATOR TO REACH TUMOURS
INSIDE THE MOUTH
FIG illustrates the novel features in the applicator - a narrow front-end and facility for only 2 electrodes in place of the usual 4 - to improve accessibility to oral cancer

tumours, especially those inside the mouth and more particularly to those at the base of the tongue.
(024) SHEET 3: INVENTION TO PROVIDE VOLTAGE OUT-PUT
CONTROL
FIG illustrates the arrangement provided for achieving output voltage control.
(025) SHEET 4: INNOVATIVE FEATURE TO CAPTURE, INTEGRATE &
DISPLAY STRUCTURED & UNSTRUCTURED DATA
Explains our innovative feature of capturing, storing and integrating structured and unstructured data to enable the doctor to have a visual and informative data to enhance decision making.
(026) SHEET 5: AUTOMATIC SYSTEM GENERATED REPORT &
MOUNTED PRINTER FOR PRINTING IT
Explains integration of different aspects into an automatic report which can be printed by a system mounted printer.
F) DETAILED DESCRIPTION OF THE EMBODIMENTS
(027) - In the following detailed description, a reference is made to the
accompanying drawings that form a part hereof, of the total description. The
embodiments are described in sufficient detail to enable those skilled in the art to
understand the invention. Logical, mechanical and other changes may be made to

this embodiment in future without departing from its present scope. The following detailed description is therefore not to be taken in a limiting sense.
(028) - SHEET 1 : FIG. illustrates the device with all its components and attachments including the regular and innovative features. This will give an overview of the device to the reader.
101 is the power cord that connects the device to the power source.
102 is the pulsator with PCBs inside and connections on the casing. Electric impulses are generated by the PCBs of the pulsator. The input and output voltage of the electric current is controlled to ensure that it stays within the range. Controlling the output voltage is an innovative safety feature of our invention.
103 is the on/off switch for the device.
104 is an indicator to indicate power on/off.
105 is the applicator socket, where applicator 109 connects to the pulsator 102.
106 is the emergency switch.
107 is the laptop. The laptop has a software application which captures structured data and stores and integrates structured as well as unstructured data. Structured data includes patient details and treatment details filled in by the doctor/device operator. Unstructured data is the the tumour images captured by a camera 108. The software application has a button through which electric impulses are fired. Report is also generated by the software application.
108, the camera, can be detached from the device to enable mobility while taking the tumour images. Once the images are taken, camera is reattached to the device

and the images are transferred to the laptop. The camera is charged once connected back to the device.
109 is the applicator which is connected to the pulsator at one end and attached to electrodes-110 at the the other. Impulses generated by the pulsator travel to the electrodes through the applicator. The applicator is held in the surgeon’s hand. 110, the electrodes are pierced into the tumour. Once the impulses are released into the tumour, they create an electric field which changes cell membrane permeability. The electrodes need to be sterilised prior to every procedure. If electrodes 110 are reusable, they need to be sterilised. If they are disposable, they should be used only for one procedure.
111 is the foot pedal. Impulses are fired either through the software application button or through the foot pedal.
112 is the printer. Printer is mounted inside the pulsator box. A small slit is provided on the pulsator for printing a system generated report.
113 shows the cancer cell whose permeability changes on application of electric impulses enabling higher uptake of chemotherapeutic medicine.
(029) SHEET 2: 2-PIN APPLICATOR FOR ORAL CAVITY CANCERS FIG 2 explains our special hand-held applicator used in oral cancer. The hand-held applicator has a narrow tip 201 for fitting 2 electrodes 202. This applicator is lean and narrow at its front end 201 to ensure better access through a small mouth opening. The applicator is serrated for a good grip 203. Applicator is attached to the pulsator with a connector 204. Impulses generated by the pulsator travel through

the applicator and its electrodes into the tumour. Electrodes (pins ) 202 are removable. 205 is a broad rim for resting the surgeon’s thumb.
(030) SHEET 3 - VOLTAGE OUTPUT CONTROL CONFIGURATION
Input voltage -low voltage 302 entering from source 301 is converted to high
voltage in voltage converter 303. High voltage is needed to bring about increase in cell membrane permeability. 304 is a voltage control filter introduced at output stage to monitor the voltage leaving the pulsator. The filter 304 also gives a feedback through 305 to the voltage converter 303 to ensure that output voltage is being released in the right range.
(031) SHEET 4: INNOVATIVE FEATURE THAT INTEGRATES
STRUCTURED & UNSTRUCTURED DATA
401 is structured data captured on laptop through the software application. It is the data entered by the device operator. 402 is images (unstructured data) captured by the system camera. Camera is detachable to give it better mobility to capture tumour images from different angles. 403 is the display of integrated and stored information captured by camera and software. This integrated information gives the doctor the complete picture to plan the next steps.
(032) SHEET 5: SYSTEM GENERATED REPORT & ITS PRINTING
WITH MOUNTED PRINTER
501 is structured data captured by the software application through data entry by the device operator. 502 is the data from the hardware which gives information

gathered in the process of treatment, e.g. the number of impulses given and the treatment completion status. An automatic report 503 is generated by system. 503 integrates structured patient data captured in the software app through data entry and treatment details acquired from hardware function. 504 is the printed report through system mounted printer.
(033) 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 claims.

We Claim:
An electro-chemotherapy device with 4 inventive features. None of these features are known to be present in all existing electro-chemotherapy devices globally.
1. The first inventive feature of the electro-chemotherapy device mentioned above is a specially designed 2 pin applicator for treating oral cavity cancers. This applicator has an innovative front portion design which is slim and narrow to enable better reach to oral cancers. It has a holder for just 2 pins (electrodes) in place of usual 4. 2 pins occupy smaller area ensuring reach inside the mouth. Tumours inside the mouth, specially those at the tongue base are often difficult to access due to the small mouth openings of patients with tumours inside the oral cavity. This applicator improves access and maneuverability to treat oral cavity cancer tumours.
2. The second inventive feature of the electro-chemotherapy device mentioned above is an output voltage control facility on electric impulses released by the pulsator of the device. This is enabled by introducing a voltage filter in the design. This filter controls the output voltage and sends a feedback to the voltage converter. This makes sure that the output voltage stays within a certain range. This feature has been designed to enhance patient and device user safety.
3. The third inventive feature of the electro-chemotherapy device mentioned above is the facility to capture, integrate and display structured and unstructured data. This is done with a connected camera that captures images (unstructured data) and a

software that captures structured data (patient and treatment details). The software integrates, and then stores and displays the integrated data to give the complete picture to the treating doctor.
4. The fourth inventive feature of the electro-chemotherapy device mentioned above is the facility to generate an automatic report by integrating structured data in the application and data from the hardware function during the electro-chemotherapy procedure. This report can be printed with the help of a mounted printer in the system.