DESC:FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(Section 10 and rule13)

SMART ORGAN TRANSPORT SYSTEM

KRIYA MEDICAL TECHNOLOGIES PVT LTD
Indian Y-Block, 5/2731, 12th Main Road, 7th Street, Anna Nagar, Chennai - 600 040, India

The following specification particularly describes the invention and the manner in which it is performed.

FIELD OF THE INVENTION
[0001] The present invention relates to the field of transportation of organs and bio-tissues. More specifically, the present invention is related to a field of transportation of organs and bio-tissues for the purpose of preservation and/or transplantation using a smart organ transportation system.
BACKGROUND OF THE INVENTION
[0002] Organ transplantation has become an essential treatment method in saving and prolonging lives in a wide variety of clinical conditions. Organ transplantation is one of the most complex procedures of medical field for several reasons. First and foremost, it involves getting a viable organ or a part of organ for a recipient patient from a matched donor. The donor and recipient may be at the same location, or organs may be transported across geographical distances from a donor site to another location.
[0003] If the donor of matched organ is at another/distant location, the preservation and transportation of the donor organ becomes very challenging. The transportation medium being used has to comply with many medical and environmental aspects while handling of the organ or a part of organ.
[0004] The most general way of handling and preserving organs is by using a “cool box” where the organ is packed and stored in ice. However, the usage of ice also limits the travelling distance that can be covered, and also does not guarantee viability due to potential variations in the temperature and damage due to physical shock. At present less than 10% of heart and lung transplant recipients in OECD countries, and even less in developing countries receive organs that they need on time, while a significant portion of organs that can be potentially harvested from accident/ willing donors in geographically distant sites due to lack of economical and affordable transportation solutions.
[0005] Further, the few patent literatures from prior art do not disclose details of a simple construction and features of the organ transportation apparatus to address the unique issues that need to be addressed in the storage and handling of organs during transportation, especially for underserved and difficult to access conditions as seen in many parts of Asia and Africa.
[0006] US patent application US20080145919 titled ‘organ and tissue preservation apparatus, kit and methods’ disclosed an organ and tissue preservation and transport apparatus comprising a chamber, a temperature control mechanism and a system monitor. A cooling system using Peltier heat pump is proposed along with a circulation system of coolant that requires a complex system of sensors to monitor. In addition an apparatus structure is proposed which is not specific in design in terms of construction and system integration for thermal and shock management.
[0007] Further, an international patent application WO2013192606 titled ‘Biopsy tissue sample transport device and method of using thereof’ disclosed of a tissue storage assembly having a sample container.
[0008] Despite of the advancement offered by the prior arts, the need remains for further improvements as there are many drawbacks to be counted such as existing solutions propose complex refrigeration solutions and apparatus architecture which may neither be cost effective nor easy to manufacture.
[0009] The need for thermal stability in a temperature range between +4°C to +8°C for upto 24 hours (depending on the organ type) is advisable in order to increase the viability of the organ and the transplantation outcome. Other Internal environmental conditions that require proper maintenance include inert and biocompatible materials, humidity control, and leak proof containment (during pressure variations such as on flights). Any cost effective design has to deploy easily available solutions for hospitals at an affordable cost without compromising on the critical internal environment required for effective organ/tissue preservation.
[00010] Apart from the above, the known transportation solutions also do not propose effective and affordable methods to provide isolation and protection against the external environmental shock and jerk mechanical inputs. Exposure to such perturbations on the organs will affect the tissue at a cellular level, therefore resulting in unsuccessful organ transplants.
[00011] Furthermore, the known system and/or methods of transporting organs do not have any donor, receiver and/or organ recognition system that can be connected to the hospital information systems/ organ transport monitoring systems.
[00012] Therefore, it is important to devise a smart organ transportation system that can overcome one or more aforementioned drawbacks and limitations of the prior art.
SUMMARY
[00013] Embodiments of the present invention provide a smart organ transport system for transporting organ and/or bio-tissues. The smart organ transportation system is comprised of a container and a data module. The container comprises an inner enclosure, an outer enclosure, an organ pouch attached to the inner side of the inner enclosure, a coolant unit arranged between the organ pouch and the inner enclosure.
[00014] In an aspect of the present invention, the organ pouch is designed to secure an organ in an organ preservation solution. The coolant unit is designed to maintain temperature stability required for viability of the organ. Further, one or more shock absorbers are arranged between the inner and the outer enclosure in a way to prevent perturbation of the organ due to any shock or jerk when organ is placed in the organ pouch.
[00015] In a further aspect of the present invention, the data module ensures the recording of data of one or more sensors arranged in proximity of the inner enclosure. Further, the data module is capable of establishing communication of recorded data from the container to a predefined user device.
[00016] It is an object of the present invention to provide a smart organ transportation system that can be capable of preserving organ or a part of organ/tissues for duration upto 24 hours, (depending on the organ) and capable of maintaining the temperature between 4 to 8°C.
[00017] It is another objective of the present invention to provide a smart organ transport system which is capable of transporting and protecting the organs included but not limiting to heart, kidneys, lungs, liver, corneal tissue, and glands such as the pancreas.
[00018] It is a further object of the present invention to provide a smart organ transport system where its design ensures that the organs being transported is kept in right biological environment with temperature and dust control. The organ pouch is designed to provide the right biocompatible, inert, dust-free, isolated and sealed environment.
[00019] It is yet an object of the present invention to provide a smart organ transport system that includes a data module to record the data including one or more of: data for organ identification, data related to recipient, data related to donor, internal temperature of container, humidity and geographical location of the transportation system. Further, the data module is communication enabled and configured to share the recorded data with a specific user device and/or with a cloud sever.
[00020] It is a further object of the present invention to provide a smart organ transport system that includes the display device for displaying real time environment conditions inside the container.
[00021] This invention is pointed out particularly with the appended claims. Additional features and the advantages of the present invention will become apparent to those skilled in the art by referring to the following detailed description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF DRAWINGS
The objects, features, and advantages of the Smart Organ Transport System (10) will be apparent from the detailed description of embodiments when read along with the below referenced drawings.
[00022] FIG. 1 depicts an exploded view of the smart organ transportation system;
[00023] FIG. 2 depicts a cross sectional view of the smart organ transportation system, and
[00024] FIG. 3 depicts the block diagram of the smart organ transportation system including the connectivity to the cloud /data infrastructure.

DETAILED DESCRIPTION OF EMBODIMENTS
[00025] The present invention will now be described in a great detailed manner with reference to the accompanying exemplary drawings for the purposes of illustrating non-limiting embodiments of the present invention.
[00026] The embodiments of the present invention disclose a smart organ transportation system for the safe transportation of an organ or a part of an organ/tissue such as included but non-limiting to heart, lung, liver, kidney corneal tissue and glands such as the pancreas etc.
[00027] As referred herein the term, ‘organ’ refers to an internal organ or a part of an organ of the human body.
[00028] As referred herein, the term ‘organ carrier’ includes an individual or organization engaged for the transport of an organ from a donor to a recipient. The ‘organ carrier’ is typically a trained professional from a hospital or specialized medical logistics service provider.
[00029] As referred herein, the term ‘donor’ is used for the person whose organ(s) are being donated for purpose of transplant to a recipient.
[00030] As referred herein, the term ‘recipient’ is used for the person who is designated to receive a donor organ as a transplant.
[00031] As used herein, the term ‘processor’ refers to any conventional or multi-chip processor or microprocessor or microcontroller that can execute information stored in data storage or memory, such as the computer readable storage medium, and/or the processor is capable of communicating over a wireless channel to the remote server/remote data storage or a remote device.
[00032] As used herein, the remote server can be, but not limited to, a hospital management system server or an organ transportation system company server.
[00033] As used herein, the remote/user device can be, but not limited to, mobile device or any information receiving device handled by a user. Other objects, features, and advantages of the use of remote/user device will be apparent from the description of the embodiments of the present invention.
[00034] As depicted in FIG. 1 and FIG.2, embodiments of present invention disclose of a smart organ transportation system (10) which enables the safe transportation of an organ from a donor to the recipient while maintaining the integrity of the organ by creating an ideal environment for the preservation of the organ during transport.
[00035] In an embodiment of the present invention, the smart organ transportation system (10) includes a container (100) and a data module (200). The container (100) includes an inner enclosure (101), an outermost enclosure (102), an organ pouch (105), a coolant unit (104) and one or more shock absorbers (103).
[00036] The system has been visualized and materials are proposed such that the total carrying weight of the container (100) is less than 20 kg (32 lbs.) including organ, organ preservation solution, the coolant unit, the inner and outer enclosures. In present embodiment, the container (100) is provisioned as a hand carry portable case.
[00037] In another embodiment of present invention, the container (100) is designed with suitable arrangements for roll-on portability with wheels.
[00038] As depicted in the Fig. 2, the inner enclosure (101) is designed at the inner side of the container (100) and the outermost enclosure (102) designed on external side of the container (100). The outermost enclosure (102) is formed to protect the inner enclosure (101) from external environmental conditions.
[00039] In an embodiment of the present invention, the inner enclosure (101) is designed such that it enables the thermal management and shock absorption. The inner enclosure (101) is preferably made of Expanded Poly Styrene (EPS) as EPS has a light weight, rigid, closed-cell structure which provides good insulation properties, impact resistance and low liquid absorption and vapor permanence. The use of EPS in inner enclosure provides thermal insulation to provide thermal stability and maintain stable required temperature during the entire transportation of the organ (107). Further the shock absorbing characteristic of EPS provides additional protection against any shock or vibration transmission into the inner cavity holding the organ.
[00040] In the embodiments of the present invention, the inner enclosure (101) works as an organ preservation chamber due to the shock absorption properties of EPS. In an embodiment, the lid of the inner enclosure (101) is integrated to a lid of outer enclosure (102).
[00041] In another embodiment of the present invention, the inner enclosure (101) has features to mount the coolant unit (104) and the organ pouch (105).
[00042] In an embodiment of the present invention, the organ pouch (105) is adapted to be kept securely inside the inner enclosure (101) and is designed to receive and secure an organ (107). In this embodiment, the organ pouch (105) is a silicone bag which is made of medical grade silicone which is free from BPA, Chlorine etc. The pouch can also be coated with anti-leach, biocompatible barriers to prevent any toxic shock to the organ and consequent rejection. The organ pouch (105) is designed to be leak-proof and easily attachable and detachable from EPS enclosure. The design of the organ pouch (105) ensures that the organ being transported is kept in the right biological environment with temperature and dust control; further the elasticity of the Silicone Organ Pouch ensures isolation of the organ and prevents additional protection against damage from mechanical shocks.
[00043] In an exemplary embodiment of the present invention, the organ pouch (105) is first filled with organ preservation solution (106) and then the organ is placed in it. The organ preservation solution (106) is to be selected based on specific temperature stability requirements and can be frozen and inserted into the container prior to transportation. It should be noted that no disclosure or claim is made relative to the organ preservation solution, it is suggested that known, approved solution and preservation fluids per medical advice and standards are to be used.
[00044] The top of the organ pouch (105) has a rigid rim which is used to fit in the inner EPS enclosure attachment scheme. The Zip lock design (can be single or multiple locks) of the organ pouch (105) makes it leak proof which prevents the organ preservation solution (106) from spilling/Leak. The organ pouch (105) is flexible and once the organ preservation solution (106) is poured it takes the shape and has close contact with the coolant unit (104). This helps to maintain proper temperature of the organ pouch (105).
[00045] In an embodiment of the present invention, the coolant unit (104) is arranged to be fit inside a cavity of inner enclosure (101) and is designed to maintain temperature required for viability of the organ (107).
[00046] In an embodiment of the present invention, the coolant unit (104) is made of rigid polyamide and is prefilled with bio-acrylic polymer gel and is sealed. In an exemplary embodiment, the coolant unit is frozen sufficiently based on transportation duration and is inserted in the inner enclosure (101). The coolant unit is easily detachable and can be refrozen for the next trip. In an embodiment of the present invention, the coolant unit (104) maintains the temperature of +4°C to +8°C up to 24 hours as required by the different organ types carried in the smart organ transport system (10).
[00047] In further embodiment of the present invention, the outermost enclosure (102) is designed with polycarbonate to reduce weight. The outermost enclosure (102) is constructed to resist denting, chipping, and cracking. Rated at NEMA 4X and 13, the material and design of outermost enclosure (102) protect it from dirt, wash downs, corrosion and coolant spraying.
[00048] In an embodiment, the outermost enclosure (102) is provided with a quick-release latch integrated with lock (Digital/Mechanical) to offer quick unfastening while preventing any midway tampering of the container (100). The container (100) of the smart organ transport system (10) is designed ergonomically for proper distribution of weight when used by the transporter and the center of gravity, with the weight of the organ (107) included, is at its geometric center.
[00049] In an embodiment of the present invention, the shock absorbers (103) are cushioned in between the inner enclosure (101) and the outermost enclosure (102) in a way to prevent perturbation of the organ (107) due to any shock or jerk when organ (107) is placed in the organ pouch (105). The shock absorbers (103) are configured to work on a shock absorption mechanism to isolate the inner enclosure (101) from any external shocks that may be transmitted due to impact loads such as sudden drop or unintentional hits on the outermost enclosure (102).
[00050] The shock absorbers (103) include shock observing bushes which are made of materials such as but not limited to rubber of suitable durometers, foam pads, mounts within built springs. The illustration in FIG. 1 has closed cell polyethylene foam mounts depicted so as not be affected by any chemicals used during cleaning and sterilization but offering excellent isolation and lightweight properties.
[00051] In an embodiment of the present invention, the shock absorbers (103) are fit on the inside surface of the outermost enclosure (102).
[00052] Referring to FIG. 3, in an embodiment of the present invention, the data module (200) is designed in the smart organ transport system (10) to ensure the recording of data of one or more sensors arranged in proximity of the inner enclosure (101). A novel arrangement of the sensors with mounting on the inner enclosure but designed through the cooling unit so as to sense the surface of the organ pouch. One or more sensors are configured for real-time monitoring of the internal environment conditions such as including but not limited to temperature, humidity and shock etc. Further, the data module (200) is capable of establishing communication of recorded data from the container (100) to a predefined user device.
[00053] In accordance with one or more embodiments of the present invention, the data module (200) includes a processor with internal memory. The data module (200) further includes BluetoothTM Module (201) and/or GSM module (202) for establishing communication. The one or more inbuilt batteries (203) and/or USB are provided for power. In some embodiments of the present invention, the data module is provided with power optimization and power saving operational modes which can be programmed to conserve available power of battery (203) during transportation. Inbuilt option for operating in offline mode is provided when connectivity is poor or lost. In offline mode the data module (200) stores all the data in the internal memory of the module and can be conveniently transmitted to the cloud server (400) when robust connectivity is restored.
[00054] In an embodiment of the present invention, the data module (200) is attached to the outermost enclosure (102) (as shown in FIG. 1).
[00055] In further embodiments of the present invention, the data can be shared to a specific user device and/or made available real time data to a monitoring station at the donor or recipient hospital using available web (205) and mobile (204) applications. These web and mobile applications may retrieved data and connected to a cloud server (400) where the data module (200) is configured to upload and store the data.
[00056] In some embodiments, the smart organ transport system (10) includes a display device (300) which can be LED /LCD or any such similar display device. The display can or cannot be integrated to the data module (200). The display device (300), attached to the outer enclosure (102), further enables the display of real time environment conditions so that the organ transport carrier will be aware of the real time environment inside the container (100). Alerts can also be programmed to notify the carrier of abnormal transport conditions. Similar alerts can also be programmed to notify the carrier/hospitals through mobile and web applications.
[00057] To enable traceability and record keeping, the entire transport history will be saved in the cloud (400) and authorized hospital personnel can access it through available web and mobile application software. The computer program will also be compatible with the HIS of the hospital.

[00058] In some embodiments, the smart organ transport system (10) may include plurality of the container (100) and further includes unique identification system which assigns a unique ID to each of the container (100). This ID is pre-programmed with encryption and displayed as QR code/Barcode in the display. This unique ID is tied to the donor patient ID and the recipient patient ID during the initialization of the transplant request. This way, the smart organ transport system (10) ensures security and avoids failures due to mismatch of donor and recipient.
[00059] The tamper proof lock (can be extended through new concepts of block chain security), along with coding of the donor, recipient and route as well as the ability to continuously monitor the transport enroute from the control center via the Web App ensures the safe and secure transport with authentication of the organ from the donor site to the recipient site.
[00060] In addition to the aforementioned one or more embodiments, the smart organ transport system (10) includes a mobile application that allows a smart phone to act as Barcode scanner to enable the carrier to scan the system and tag the transport system ID to the donor and /or recipient.
[00061] It is also stated that the computer code for implementing the embodiment can be in any programming language, configured for varying hardware/software architectures and flexible to be compatible to various latest version of communication protocols such as BluetoothTM and GSM.
[00062] Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are merely intended to facilitate an understanding of ways in which the embodiments herein may be designed. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[00063] The foregoing description of the specific embodiments 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 as 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.
[00064] The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.
[00065] While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
,CLAIMS:CLAIMS

I/We claim
1. A smart organ transportation system (10) comprising:
a container (100), the container (100) is comprised of-
-an inner enclosure (101) designed on internal side of the container (100);
-an outermost enclosure (102) designed on external side of the container (100) and is formed to protect the inner enclosure (101) from external environmental conditions;
-an organ pouch (105) arranged at inner side of inner enclosure (101) and designed to receive and secure an organ (107);
-a coolant unit (104) designed to be clipped to the inner enclosure (101) and configured to maintain temperature required for viability of the organ (107), and
-one or more shock absorbers (103) arranged in a way to prevent perturbation of the organ (107) due to any shock or jerk when organ (107) is placed and transported in the organ pouch (105), and
a data module (200) attached to the outer enclosure (102) to ensure the recording of data of one or more sensors arranged in proximity of the inner enclosure (101), the data module (200) is capable of establishing communication of data from the container to a predefined user device and/or a cloud server (400).
2. The smart organ transportation system (10) as claimed in claim 1, wherein, the organ pouch (105) is filled with specific organ preservation solution (106) to preserve the organ.
3. The smart organ transportation system (10) as claimed in claim 1, wherein, the organ pouch (105) is arranged to have Ziplock type arrangement to seal the organ pouch (105).
4. The smart organ transportation system (10) as claimed in claim 1, wherein the coolant unit (104) is prefilled with bio-acrylic polymer gel.
5. The smart organ transportation system (10) as claimed in claim 1, wherein the coolant unit (104) is made of polyamide.
6. The smart organ transportation system (10) as claimed in claim 1, wherein the coolant unit (104) is configured to be clipped in a cavity like structure designed around the inner side of the inner enclosure (101).
7. The smart organ transportation system (10) as claimed in claim 1, wherein the inner enclosure (101) is made of expanded polystyrene.
8. The smart organ transportation system (10) as claimed in claim 1, wherein the outermost enclosure (102) is made of light weight polycarbonate material.
9. The smart organ transportation system (10) as claimed in claim 1, wherein the data module (200) is configured for the recording data of one or more of including temperature, humidity, pressure and container location data.
10. The smart organ transportation system (10) as claimed in claim 1, wherein the data module (200) is configured to be capable of:
-recording data in both online and offline modes, and
-communicating with a display (300) attached to the outer enclosure (102) to reflect the status of the organ pouch critical parameters, and information related to the donor, recipient, organ carrier, route.
11. A smart organ transportation system (10) comprising:
a container (100), and
a data module (200);
wherein the container is designed to secure an organ and the data module (200) is configured to record the data including one or more of: data for organ identification, data related to recipient, data related to donor, internal temperature of the container (100), humidity and location of the container (100);
further, wherein the data module (200) is communication enabled and configured to share the recorded data with a specific user device and/or with a cloud sever (400).
12. The smart organ transportation system (10) as claimed in claim 11, wherein the specific user device is enabled, by a mean of computer coded instructions and a specific user application, to get information of one or more of: accurate location of container, the status of transport and other critical parameters.
13. The smart organ transportation system (10) as claimed in claim 11 further comprises a display device (300) for displaying real time environment conditions inside the container (100).
14. The smart organ transportation system (10) as claimed in claim 11 further comprising a provision to assign a unique ID to the container (100) while carrying the organ (107) for organ identification.

Dated this 08th day of August 2020

Bency Varghese
Patent Agent for the applicant