WO2022136998A1

WO2022136998A1 - Cryogenic freeze drying based organ storage device and methods thereof

Info

Publication number: WO2022136998A1
Application number: PCT/IB2021/061490
Authority: WO
Inventors: Sagar Nandkumar DESHPANDE
Original assignee: Deshpande Sagar Nandkumar
Priority date: 2020-12-21
Filing date: 2021-12-09
Publication date: 2022-06-30

Abstract

A cryogenic freeze drying based organ storage device is provided herein. The device includes an outer shell 1 with a top cover 4 and the outer shell encapsulates an inner shell 2 which is separated by an insulation 3 on all sides except top side, the inner shell 2 forms a chamber 2A within the shell 2, covering all the sides of an organ holder outer shell 5 except top, wherein the outer shell 5 accommodates an organ holder 6 within the outer shell 5, a multiple fans 7 detachably placed within the chamber such that the fans when operational, uniformly circulates various gases such as O2, N2, etc. inside the chamber; a vacuum pump to squeeze out the gases from chamber, and a seal 17 which terminates the insulation 3 at top of the outer shell 1 and also facilitates concealing of the device with top cover 4.

Description

CRYOGENIC FREEZE DRYING BASED ORGAN STORAGE DEVICE AND METHODS THEREOF

BACKGROUND

Technical Field

The embodiments herein generally relate to an organ storage system and more particularly to, a cryogenic freeze drying based organ storage system and method which facilitates substantially longer timelines for organ preservation by maintaining equilibrium for the cytoplasmic perfusion and preservation of mechanics of blood and glucose equilibrium in an active extra-corpuscular environment.

Description of the Related Art

Current approaches:

Hypothermia has been the dominant theme in the attempts over the past six decades from early 1960s to preserve organs for facilitating transplantation through the compatibility matching of tissue and metabolism between the host and the donor corpuscular entities.

The focus for organ transplantation has so far been on simulating blood perfusion and near simulation of the parameters of the effective blood metabolism. The underlying factors of ischemic delay and related reperfusion injury otherwise clinically acronym as IRI are the driving forces of preservation solutions. The clinical nomenclature for machine induced perfusion for the transplanted organ is HMP or hypothermal machine induced perfusion. The limitations of oxygenation is reportedly proved to be 5% at hypothermic states as compared to 37 degrees Celsius and the related issues of blood metabolism have to be overcome through simulating the body temperature range of 34 - 37 degrees Celsius environment. Other approaches are by using Collins solutions and UW - University of Wisconsin solutions for preservation are the widely regarded solutions that have been adapted in practice.

However, all the above approaches also face certain challenges which are listed below: a) The IRI or ischemic reperfusion injury are the major areas of challenges in modern day organ transplant procedures. b) Significantly reduced oxygenation capacities following cold storage of organs is another of the major problems which may be faced. c) Imbalances in vital body electrolytes during storage and diminished powers to recoup on a successful organ transplant caused by homeostatic disorders are the major challenges in the containment of post-surgery complications.

Accordingly, there remains a need for an apparatus or technique which can be used to overcome above challenges in preservation of organs and also which facilitates substantially longer timelines for organ preservation at a cost viable and efficient solution.

SUMMARY

The present embodiment herein provides a cryogenic freeze drying based organ storage device. The said device includes an outer shell with a top cover, wherein the outer shell encapsulates an inner shell separated by an insulation on all sides except top side, wherein characterized in that the inner shell forms a chamber within the shell, covering all the sides of an organ holder outer shell except top side, wherein the outer shell accommodates an organ holder within the outer shell, wherein the chamber so formed has sufficient space to include a multiple fans detachably placed within the chamber such that the fans when operational, uniformly circulates various gases such as 02, N2, etc. inside the chamber; a vacuum pump to squeeze out various gases from the chamber as and when needed; and a seal which terminates the insulation at top of the outer shell and facilitates concealing the outer shell with top cover.

In an embodiment, the chamber includes a humidifier, a temperature controller, a temperature sensor, a humidity sensor, a gas analyzer and a pressure sensor. The organ holder may be of any geometric shape configured to accommodate various organs of humans, animals, etc.

In an embodiment, the organ holder may be stacked one above the other within the organ holder outer shell.

The present embodiment also elucidates, a method to store organs within an cryogenic freeze drying based organ storage device. The said method incudes following steps:

Step 1 : atomizing air at a temperature range of -200 to -183 degrees Celsius to promote the atomization of the air particles within a chamber to obtain a mist through ultrasonic impact;

Step 2: freezing mist into colloids at a temperature range of -182 to -146 degrees Celsius thereby liquifying inert gases and then extracting condensed air droplets;

Step 3: cryogenic drying of the condensed air droplets; and

Step 4: drying the condensed air droplets through a vacuum plate dryer mechanism which elevates temperature of the medium at a level of 37 to 40 degrees Celsius as determined by physio-morphological states and the gradient therein between the donor and the recipient.

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 THE DRAWINGS

Reference will be made to embodiments of the invention, examples of which may be illustrated in the accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments:

The embodiments herein will be better understood from the following detailed description with reference to the drawings, in which:

FIG. 1 illustrates a cryogenic freeze drying based organ storage device according to an embodiment mentioned herein;

FIG. 2 illustrates a step by step process of cryogenic freeze drying of the organ in the organ storage device according to an embodiment mentioned herein;

FIG. 3 illustrates a process flow diagram of a cryogenic freeze drying based organ storage system according to an embodiment mentioned herein;

FIG. 4 illustrates schematic representation of cryogenic drying process according to an embodiment mentioned herein; FIG. 5 illustrates schematic representation of receiving bay according to embodiment mentioned herein; and

FIG. 6 illustrates schematic representation of the organ storage box with entropy minimization, achieving dry air in the range 98 to 99.9% and sensible heat between 35 and 37 degrees Celsius according to an embodiment mentioned herein.

Persons skilled in the art will appreciate that elements in the figures are illustrated for simplicity and clarity and may have not been drawn to scale. For example, the dimensions of some of the elements in the figure may be exaggerated relative to other elements to help to improve understanding of various exemplary embodiments of the present disclosure.

Throughout the drawings, it should be noted that like reference numbers are used to depict the same or similar elements, features, and structures.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the invention selected for illustration in the drawings, and are not intended to define or limit the scope of the invention.

References in the specification to “one embodiment” or “an embodiment” member that a particular feature, structure, characteristics, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. In the following description, for purposes of explanation and not limitation, specific details are set forth such as particular architectures, interfaces, techniques, etc. in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details. That is, those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. In some instances, detailed descriptions of well-known devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail. All statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.

Accordingly, there remains a need for an apparatus or technique which can be used to overcome above challenges in preservation of organs and also which facilitates substantially longer timelines for organ preservation at a cost viable and efficient solution. Here, the pertinent range of human organs meant for transplantation are physiologically matched for perfusion properties and simulating the metabolism of blood and glucose whilst ensuring the balances of electrolytes through an atmosphere of 98% - 99.9% purity of dryness in the air at one atmospheric pressure and while maintaining a sensible heat range of 35 degrees Celsius to 37 degrees Celsius. The entropy is minimized to ensure conservation of the atmospheric conditions in the organ chamber while insulating completely from the external milieu.

DELINEATING THE INFLUENCE DETERMINANTS -

PHYSIO-MORPHOLOGICAL CHARACTERISTICS A.1. PERFUSION AS THE PRINCIPAL DETERMINANT a) The morphological characteristics of perfusion of blood in the cell are influenced by the frictional aspects of the tissue barrier that the arterial blood has to overcome and consequently, have major variables governing the process. The orientation of tissues in the vital organ for achieving the perfusion is influenced by the following aspects that have profound impact on the worthiness of the said organ for a transplantation process at the outset:

1. The serum properties that determine the viscosity, fluid friction across tissue barriers and the flash point fidelity for the thermodynamic sensitivity to resist septicaemia during homeostasis are of interests here. The principles incorporated in the design for the preservation of organ shall be fundamentally governed by the capacities to retain the serum perfusion aspects through the tissues and cellular interfaces of the organ in situ.

2. The capacities to achieve homeostasis on transplantation would depend on the capacities to retain the original electrolyte balances that the organ in situ had been acclimatized to in the body of the donor. The electrolytic imbalances are synchronized with the perfusion properties empirically in situ and the states of positive as well as negative signalling routing in the homeostatic environment of the donor. Imbalances in the electrolytic properties set in functionally as components of the serum deterioration and the concomitant signalling fuddle triggered by disruptions in the auto-immune chain of signals.

In the event of a healthy donor sans the serum and immunity triggered potential disruptions of the electrolytic imbalances, the environment for the organ preservation has to be structured around the preservation of tissue balances for both hemodynamics and thermodynamics. The compatibility or near approximation of the same for serum match in properties between the donor and recipient as well as the bridging of the intervening timeline in the organ box requires an ideal ambience for achieving potential fluid equilibrium at static mode.

3. The electrical field and the myelination of the sensory nerve endings into the organs are major influences that need to be examined and correlated for an effective preservation regime. The strength of flux of the electrical signaling through the plexus and the consistency as well as fidelity of the myelination of the nerve pathways define the resistance to serum and consequently the properties of perfusion.

Mathematically, expressions can be derived for an analysis of perfusion properties in an organ:

0 (X)~ 5x/5t— (1)

Where 0 (X) is the flux strength at any coordinate within the organ and is a partial differential of the vector as defined by (II (x)0n)

(II (x)0n) k - (2)

The magnitude of the vendor is a summation function of each of the field forces at various coordinates in the organ field wherein perfusion occurs; 0 being the minima in the domain when perfusion potentially non-exists and n being the description of the condition wherein cytoplasmic perfusion is at its physiological maximum. K is the physical constant which allows the gravitation of the perfusion quality between a minim and the potential maxima. K is a vital parametric constant that helps define the physio - morphological states of the organ in the aspects of the perfusion properties.

Final derivative for perfusion quality in an organ as defined at the coordinates of the nerve plexus:

Key derivatives of the perfusion equation: i) The flux strength across the nerve pathways in the organ plexus is the major determinant in defining the perfusion map across the coordinates. The fluctuations on flux strength are attributed to CNS functionality and relative fidelity of the field onset. CNS - central nervous system is the primary seat of the immune system as well as the seat for generation of the electrical impulses that cascade through the nerves.

Optimal blood perfusion in the cerebral cells eventually determines the strength of the flux and the causation of the dielectric field in the CNS or in the nerve terminals of the organ plexus. This is of singular importance in determining the organ’s intrinsic capabilities in achieving homeostasis on real time acclimatization needs with a recipient and the pathological conditions therein for the serum characteristics. ii) The organ sensitivity to transmitter and receptor cells in the blood is the key for achieving immune insulation on the transplantation process. The perfusion characteristics have to be augmented by equilibrium of electrolytes and the tissue preservation for receiving the flux strength at optimality with nominal creation of the dielectric field thereby precluding the cause for quenching static fields in charge precipitation. iii) K as an equilibrating constant that effectively summarizes the coordinates for a steady state organ field in the realm of hemodynamic stability as well as thermal statics.

The equilibrium for the cytoplasmic perfusion and preservation of the mechanics of blood and glucose equilibrium in an active extra-corpuscular environment that simulates the corpuscular conditions of both the arterial and venous micro-vascular states is the core objective of the present embodiment which facilitates the organ preservation for substantially longer timelines than are currently available solution. Referring now to the figures, more particularly from FIG. 1 to FIG. 6, where similar reference characters denote corresponding features consistently throughout the figures, preferred embodiments are shown.

FIG. 1 illustrates a cryogenic freeze drying based organ storage device according to an embodiment mentioned herein. The device includes an outer shell 1 with a top cover 4, the outer shell may be encapsulated with an inner shell 2 which may be separated by an insulation 3 on all sides except top side,

In an embodiment, the inner shell 2 forms a chamber 2A within the shell 2 covering all the sides of an organ holder outer shell 5 except top, wherein the outer shell 5 accommodates an organ holder 6 within the outer shell 5. In an embodiment, the chamber so formed has a sufficient space to include a multiple fans 7 detachably placed within the chamber such that the fans when operational, uniformly circulates various gases such as 02, N2, etc. inside the chamber.

The device also includes a vacuum pump to squeeze out the gases from chamber as and when needed and a seal 17 which terminates the insulation 3 at top of the outer shell 1 and also to facilitate concealing the device with top cover 4.

In an embodiment, the device with the chamber includes a humidifier 11 , temperature controller 12, temperature sensor 13, humidity sensor 14, a gas analyzer 15 and a pressure sensor 16. In one example embodiment, the organ holder 6 is of any geometric shape configured to accommodate various organs of humans, animals, etc.

THE ESSENCE OF THE WORKING PRINCIPLE OF EXTRACTING MOISTURE LESS AIR

The ultrasound frequencies are used to atomize the air with varying intensity on the stream of air. The air is injected into an increasingly intense field of ultrasound frequencies to establish the effective atomization in an essentially Fourier transforms on a mathematical interpretation.

Assuming stream volume per unit space or specific volume as vs

Predictably, the overall volume into the cryogenic medium -1 is a binomial expansion wherein n is the discrete timeline and x is the particle density in the air stream within an infinitesimally narrow domain bandwidth thereby meriting assumption uniformity in particle density as governed by the gaseous states and the colloidal distribution of the suspension.

The intensity of ultrasound frequency is r|(n) wherein IJ represents the domain of the frequency imparted and the value a implies the instantaneous absolute frequency imparted on the air stream. r|(b) is the lower frequency coordinates in the domain parameters of the ultrasound frequency mechanism.

L is the limiting length of the air stream for a time line as fixed for one discrete passage of air in the module.

The effectiveness of the atomization shall follow a Fourier transform.

The Fourier transform implies the periodic applications f alternating low and high intensities of frequencies thereby causing an exponential impact on the atomizing pressure.

This is required to incorporate a stream of uniform particles of liquefied air mist. The minimization of entropy within the mist shall be of singular importance in establishing the subsequent cryogenic freezing and eventual drying through the VPD.

PHYSICAL MECHANISM OF LIQUEFYING, EXTRACTING THE AIR SOLVENT AND DRYING THE AIR

The cryogenic boundaries nomenclature of 1 through 3 is meant to establish the cryogenic environment for the process. Thus, Cryogenic boundary -1 is for atomizing the air at a typical temperature range of (-200) to (-183) degrees Celsius to promote the atomization of the air particles. The domain range for the magnitude of atomization depends on the ultrasound frequencies as well as the distribution of the air colloids and the chemical configurations therein. Thus the Fourier transform is indicative of the air stream dynamics for instantaneous particle friction, specific volume and the colloidal distribution that defines the particle boundary temperature in the backdrop of the cryogenic boundary -1.

The second step in the process is the incorporation of the inert cryogenic fluid particles to freeze the mist and create colloids of frozen particles for cryogenic feeding into the cryogenic boundary -3 of (-145) to (-125) degrees Celsius.

The second step of freezing the mist into colloids however occurs at cryogenic boundary (-182) to (-146) degrees Celsius. The second step is a quenching process and influences the entire range of mist particles. The enthalpy differences between the mist and the cryogenic medium are so vast that none of the mist particles can escape the effects of quenching into freezing mode at an extremely rapid pace. Cryogenic drying is the terminal stage of the process before the medium moves into step-4 wherein the VPD - vacuum plate dryer mechanism sets in to elevate the temperature of the medium to the desired level of (37) to (40) degrees Celsius as determined by the physio-morphological states and the gradient therein between the donor and the recipient as discussed in the preceding sections of the article.

Major differentiating features that guide the cryogenic boundaries 1 through 3 and establish the desired air properties with simultaneous drying to expected organ preservation temperatures are as follows: i) Entropy minimization owing to the enthalpy gaps between the air and the inert cryogenic medium. ii) Extrusion of the colloids defined purification in a freezing medium and subsequent cryogenic heating to seamlessly dry. The seamless transition between the freezing and drying of air achieves the purification of the air and brings in consistency in the properties of the air that is fed to the vacuum plate drying chamber to restore the near-inert state of preservation; so very vital to the longevity of the storage process for organoleptic organs. iii) The step-4 is more of achieving consistency in the temperature of the preservative medium for the organ and is a function of the cryogenic process. The eutectic properties of air shall vary with time and place of occurrence of the storage conditions. The vagaries of particle density are determined by the ambient temperatures and the colloids in the suspension of the air particles in the atmosphere.

A two-stage sequencing of the cryogenic process as described above shall be fundamentally important in achieving fidelity for particle equilibrium and colloidal properties to an extent of 95% minima purity. This is the step of profound importance in the entire sequential process.

C3. AIR VOLUME AS A FUNCTION OF SPATIAL CONFIGURATION IN THE PRESERVATION CHAMBER

The air volume release after drying and heating up to the computed orglan room temperature shall be functionally defined by the entropy accepted at the equilibrium conditions.

a = spatial volume of the organ box b = volume of air introduced in the vacuum of the organ box at an inclination 9 to the axis of flow of

Air

The equilibrium of the box is functionally governed by the random movement of air that changes the entropy in the system. The volatility of air particles at the desired temperature range of 37 - 40°C is the baseline determinant for evaluating the influence of remnant moisture after the cryogenic drying and the VPD induced temperature for managing the spatial angle of the air.

Higher the angle described by the summation of air particles as described in the equation, greater shall be the instability.

Thus, the equation describes the primary volume functionally determined by the spatial angle described by the particle that can usher in the minimum entropy and consequently, the retention of the physiological properties of the organ under the purview. OPERATING AND HANDLING PROCEDURE

El . Preparation for organ transplant

1. Clean equipment all parts like outer shell, inner shell, top cover etc with normal medical grade disinfectant or IPA 70% as per normal medical practice

2. Connect with power for ideal running and test for performance of equipment

3. Once the harvested organs are ready for transport then with help of HMI open top cover of equipment and remove internal shelf to put harvested organs.

4. After putting internal shelf including organs close the inner and outer shell covers.

5. With help of HMI feed necessary data to the system.

6. Give input of Donor and Recipient body temperature, other required medical details (Name / Unique code, Age, Gender, sizes of harvested organs etc) to the system.

7. Run the equipment on actual mode.

8. Equipment is ready for the moving harvested organs with relevant personals (Doctors, OPO, NGO etc.) through road or air.

9. Once its reaches at destination of recipient then donors’ doctor and recipients’ doctors have to share unique code feeds to equipment to unlock for transplant.

10. After transplant procedure equipment supposed to put on ideal condition for self-cleaning through N2.

11. After completion of self-cleaning cycles doctors can open the equipment again and clean manually if they require

12. Before the next harvested organ transplant repeat same procedures for better performance. B - OPTIMIZING ORGAN PRESERVATION PARAMETERS:

Example 1

Example 2

KEY NOTES:

E Tabular analysis of vital data and the influence weights have helped define the overall strength for vitals and the metabolic factors for the patients; both donor and the recipient in a classical organ transplant protocol.

2. Establishing the strong correlation between the determinants and the parametric influences are fundamentally important for the structuring of the homeostatic equilibrium for storage longevity and retention of electrolytic balances for improved functionality in the morphological medium of the recipient. In an embodiment, the organ holder 6 may be stacked one above the other within the organ holder outer shell 5. In an example embodiment, Spray freeze drying techniques may be used as an extension of the implementation program for the organ storage device in the purview of the present embodiment.

FIG. 2 illustrates a step by step process of cryogenic freeze drying of the organ in the organ storage device according to an embodiment mentioned herein. The method contains following steps:

Step 1 : atomizing air at a temperature range of (-200) to (-183) degrees Celsius to promote the atomization of the air particles within a chamber 2A through ultrasonic impact;

Step 2: freezing mist into colloids at (-182) to (-146) degrees Celsius for liquifying inert gases and extracting condensed air droplets;

Step 3: cryogenic drying of the condensed air droplets; and

Step 4: drying the air droplets through a vacuum plate dryer mechanism which elevates temperature of the medium at a level of 37 to 40 degrees Celsius as determined by physio-morphological states and the gradient therein between the donor and the recipient.

FIG. 3 illustrates a process flow diagram of a cryogenic freeze drying based organ storage system according to an embodiment mentioned herein. The steps to maintain a proper environment within the organ box is as follows:

In step 1, cryogenic freezing may be carried out in two stages. First for exhausting moisture to the extent of 85% in stage -1 and then to 95% in stage-2 with a vacuum pressure maintained at 25 Bar and a temperature range for Nitrogen from -185 degrees Celsius (-185°C) to -135 degrees Celsius (-135°C).

In step 2, a vacuum plate dryer configured to maintain pressure at 30 bars on a space of 0.5 cubic meter (0.5m3) to ramp up the temperature in the range of 35 degrees Celsius (35°C) to 37 degrees Celsius (37°C).

In step 3, opening passage bay of 0.3 cubic meter (0.3m3) volume may be connected to cryogenic feed input for freeze drying as is in Step-1 and subsequent VPD (vacuum plate dryer) drying as in Step-2 thereby establishing a virtual cyclic process. This process may be continuous thereby ensuring high fidelity equilibrium within the organ chamber.

STEP-1 : Ramp series for the cryogenic freezing is best expressed by the equation:

RR(x) = n/2-n/ =cosx/k+cos3x/k2+cos5x/k3+ ....

The freezing curve follows a tonicity in a specific vacuum pressure thereby elevating the eutectic and crystalline points of the air-drying process. The universal indicators in a time axis are implied by the decay time k as the step function, k2 as the ramp function, k4 as the spline functions and generic rk where r< 1 as the analytic function in the spatial entropy (angular displacement as defined by cos(x) and further derivatives)within the box.

Ramping on a tonicity as expressed in the equation shall be the cornerstone for achieving high fidelity of drying accuracy in the range of 98 - 99.5% purity on mathematical prediction on stochastic mode.

STEP-2: Orthogonality of the heating series in dry air as reflected by the complete Fourier series : f(x)=aO+E ancosnx+ G bnsinnx where, ao is the gravitating point of the orthogonality that eliminates the miniscule changes in the entropy, an is the resolution of the entropy in the vertical plane and bn is the resolution of the entropy in the horizontal plane.

FIG. 4 illustrates schematic representation of cryogenic drying process in stage 1 according to an embodiment mentioned herein. Here, the cryogenic compression may be achieved over eutectic and crystalline coordinates of the air. Further, the air compression is seamless and within narrow coordinates of eutectic points with 98% reduction in entropy may be achieved from Stage -1.

FIG. 5 illustrates schematic representation of receiving bay according to embodiment mentioned herein. Here, the Vacuum plate heated dried air maintains </= 5% moisture at sensible heat of 37 - 38 degrees Celsius and also flushes out air under vacuum.

In one embodiment, the entropy range may be defined by E(a) = log (p) + c wherein E(a) is the range from 5 ml to 100 ml in an enclosed space of 0.5m3. Which may be maintained with a steady temperature of 37 degrees Celsius within 0.05% variation to achieve steady state equilibrium required for the preservation of the human organ for a minimum timeline of 500 hours or more. Here, the logarithmic function denotes the fundamental stochastic nature of the process and establishes the likelihood function of equilibrating heat in the system.

The properties of extra-corpuscular perfusion in a human organ may effectively eliminate the risk of IRI or ischemic reperfusion injury on transplant of the organs like liver, heart, kidney, lungs and eyes, but not limited to the embodiments mentioned herein. That electrolytes balance and concentration level shall be within 3% of the last recorded baseline values of the organ in the host during healthy state dynamics prior to death of the donor.

The organ chamber or box achieved from the present embodiment has no fresh tissue damages observed after the transplant process even after preservation for a minimum of 500 hours. In an embodiment, the organ chamber may insulate the organ effectively across extreme weather conditions in the ambient within a range of - 15 degrees Celsius (-15°C) to 50 degrees Celsius (50°C). In an example embodiment, the organ chamber may withstand aircraft transfer as well as all known modes of surface transport.

In an embodiment, no fresh tissue damage can be observed after the transplant process even after preservation for a minimum of 500 hours. The evaluation for metabolism of blood, glucose and the muscle shall be done for both the donor and the recipient and on a proprietary formulation, the ideal temperature for the organ box shall be computed for implementation. Essential derivative of the present invention is the implementation of the temperature and air density regime founded on the gradient of the metabolic condition between the donor and the recipient to enable minimized lead time for homeostasis to be restored after the transplantation. Here, the oxygenation properties of the organ cannot alter from the healthy state donor levels on the transplant after a minimum of 500 hours of preservation in the organ box.

Singularly important breakthroughs may be achieved through incorporation of waves of specific family of amplitudes, wavelengths and frequency that simulate a host of conditions known to have therapeutic effects on the CNS or central nervous system. The spectrum of waves do help preserve the tissues and prevent the tissue degeneration as well as decline in the electrolytic concentration within the organ and also in the corpuscular states of the recipient.

The gravitational entropy at equilibrium causes the steady state of sensible heat to manifest in pure dry air thereby provisioning for minimization of attributes that can potentially disrupt tissue. The conditions obtained within the organ box solves the problem by simulating the corpuscular conditions to overcome the challenges through engineering air that minimizes entropy, achieves steady state thermal equilibrium with near non-existent interventions of either air constituents or moisture. Thus, improved organ storage/ preservation system is achieved from the present embodiment.

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.

Claims

CLAIMS We Claim:

1. A cryogenic freeze drying based organ storage device 100, said device comprising: an outer shell 1 with a top cover 4, wherein the outer shell encapsulates an inner shell 2 separated by an insulation 3 on all sides except top side 5A, wherein characterized in that the inner shell 2 forms a chamber 2A within the shell 2, covering all the sides of an organ holder outer shell 5 except top side, wherein the outer shell 5 accommodates an organ holder 6 within the outer shell 5, wherein the chamber so formed has sufficient space to include a multiple fans 7 detachably placed within the chamber such that the fans when operational, uniformly circulates various gases such as 02, N2, etc. inside the chamber; a vacuum pump 10 to squeeze out various gases from the chamber as and when needed; and a seal 17 which terminates the insulation 3 at top of the outer shell 1 and facilitates concealing the outer shell 1 with top cover 4.

2. The organ storage device as claimed in claim 1, wherein the chamber includes a humidifier 11, a temperature controller 12, a temperature sensor 13, a humidity sensor 14, a gas analyzer 15 and a pressure sensor 16.

3. The organ storage device as claimed in claim 1, wherein the organ holder 6 is of any geometric shape configured to accommodate various organs of humans, animals, etc.

4. The organ storage device as claimed in claim 1, wherein the organ holder 6 is stacked one above the other within the organ holder outer shell 5.

24

5. A method to store organs within an cryogenic freeze drying based organ storage device 100, said method comprising:

Step 1 : atomizing air at a temperature range of -200 to -183 degrees Celsius to promote the atomization of the air particles within a chamber 2A to obtain a mist through ultrasonic impact;

Step 3: cryogenic drying of the condensed air droplets; and Step 4: drying the condensed air droplets through a vacuum plate dryer mechanism which elevates temperature of the medium at a level of 37 to 40 degrees Celsius as determined by physio-morphological states and the gradient therein between the donor and the recipient.