Technique for treating a human organ during transport

文档序号:957307 发布日期:2020-10-30 浏览:3次 中文

阅读说明:本技术 用于在运输期间处理人体器官的技术 (Technique for treating a human organ during transport ) 是由 约瑟夫·R·斯卡莱亚 斯特芬·雷斯塔伊诺 于 2019-01-18 设计创作,主要内容包括:提供了用于监测及运输解剖学器官的技术,该技术具有套筒,套筒紧密地围绕器官布置并且包括对于附至无人空中交通工具的容器中的水溶液是的多孔的材料。作为非限制性示例,在第一组实施方式中,成形为近似于目标解剖学器官的形状的套筒具有用于使目标解剖学器官插入的开口。套筒可以包括对于水溶液是多孔的且具有用于保持套筒和目标解剖学器官的重量的抗拉强度的织物。在其他实施方式中,套筒的织物还可以包括用于使目标解剖学器官的血管穿过的不同的第二开口。此外,套筒可以包括无线通信装置、以及温度传感器和振动传感器中的至少一者。(Techniques are provided for monitoring and transporting an anatomical organ having a sleeve disposed closely around the organ and comprising a material that is porous to an aqueous solution in a container attached to an unmanned aerial vehicle. By way of non-limiting example, in a first set of embodiments, a sleeve shaped to approximate the shape of a target anatomical organ has an opening for insertion of the target anatomical organ. The sleeve may include a fabric that is porous to the aqueous solution and has a tensile strength for maintaining the weight of the sleeve and the targeted anatomical organ. In other embodiments, the fabric of the sleeve may further include a second, different opening for passage of a blood vessel of the target anatomical organ. Further, the sleeve may include a wireless communication device, and at least one of a temperature sensor and a vibration sensor.)

1. An anatomical organ sleeve comprising a fabric that is porous to an aqueous solution and has sufficient tensile strength to maintain a weight of the sleeve and a weight of a target anatomical organ, wherein the sleeve is shaped to approximate a shape of the target anatomical organ and has a first opening configured for insertion of the target anatomical organ into the sleeve.

2. The sleeve of claim 1, wherein the fabric is readily shearable with surgical scissors, and the sleeve is further shaped to have a second, different opening configured for passage of a blood vessel of the target anatomical organ.

3. The sleeve of claim 1, further comprising a temperature sensor attached to said fabric of said sleeve.

4. The sleeve of claim 1, further comprising a vibration sensor attached to the fabric of the sleeve.

5. The sleeve of claim 1, wherein said sleeve is shaped to closely conform to said target anatomical organ.

6. The sleeve of claim 1, wherein said fabric comprises neoprene.

7. The sleeve of claim 1, wherein said target anatomical organ is one of a human kidney, a human heart, a human lung, a human spleen, a human pancreas, and a human eye.

8. A system, comprising:

an anatomical organ sleeve comprising a fabric having sufficient tensile strength to maintain a weight of the sleeve and a weight of a target anatomical organ, wherein the sleeve has a first opening configured for insertion of the target anatomical organ into the sleeve;

a container configured to hold an aqueous solution;

a temperature sensor configured to be in thermal contact with the sleeve when the sleeve is located inside the container, wherein the temperature sensor is configured to produce a corresponding plurality of temperature measurements at a plurality of different temperature times; and

a wireless communication device configured to communicate with the temperature sensor and configured to wirelessly transmit first data based on the plurality of temperature measurements.

9. The system of claim 8, wherein the sleeve is shaped to approximate a shape of the target anatomical organ.

10. The system of claim 9, wherein the fabric is readily shearable with surgical scissors and the sleeve is further shaped to have a second, different opening configured for passage of a blood vessel of the target anatomical organ.

11. The system of claim 9, wherein the sleeve is shaped to closely conform to the target anatomical organ.

12. The system of claim 8, wherein the fabric is neoprene.

13. The sleeve of claim 8, wherein said target anatomical organ is one of a human kidney, a human heart, a human lung, a human spleen, a human pancreas, and a human eye.

14. The system of claim 8, wherein the temperature sensor is attached to the fabric of the sleeve.

15. The system of claim 14, wherein the temperature sensor is attached to the container.

16. The system of claim 8, further comprising a vibration sensor in mechanical contact with the sleeve when the sleeve is positioned inside the container and configured to produce a corresponding plurality of vibration measurements at a plurality of different vibration times, wherein the wireless communication device is further configured to communicate with the vibration sensor and configured to wirelessly transmit second data based on the plurality of vibration measurements.

17. The system of claim 16, wherein the vibration sensor is attached to the fabric of the sleeve.

18. The system of claim 16, wherein the vibration sensor is attached to the container.

19. The system of claim 8, further comprising a global positioning system receiver configured to produce a corresponding plurality of position measurements at a plurality of different position times, wherein the wireless communication device is further configured to communicate with the global positioning system receiver and to wirelessly transmit second data based on the plurality of position measurements.

20. The system of claim 19, wherein the global positioning system receiver is attached to the container.

21. The system of claim 8, further comprising an air pressure sensor configured to generate a corresponding plurality of air pressure measurements at a plurality of different air pressure times, wherein the wireless communication device is further configured to communicate with the air pressure sensor and configured to wirelessly transmit second data based on the plurality of air pressure measurements.

22. The system of claim 19, wherein a height sensor is attached to the container.

23. The system of claim 8, further comprising:

at least one processor; and

at least one memory including one or more sequences of instructions, the at least one memory and the one or more sequences of instructions configured to, with the at least one processor, cause the system to perform at least the following:

receiving the plurality of temperature measurements and determining the first data,

storing the first data in the at least one memory, an

Cause the wireless communication device to transmit the first data.

24. The system of claim 8, wherein the wireless communication device is a radio transceiver.

25. An apparatus, comprising:

a radio transceiver;

at least one processor; and

at least one memory including one or more sequences of instructions, the at least one memory and the one or more sequences of instructions configured to, with the at least one processor, cause the system to perform at least the following:

receiving metadata indicative of an anatomical organ;

receiving from the radio transceiver first data: the first data is based on a corresponding plurality of temperature measurements from the temperature sensor at a plurality of different temperature times,

The temperature sensor is in thermal contact with the anatomical organ located inside a container configured to hold an aqueous solution;

storing the first data in the at least one memory in association with the metadata of the anatomical organ;

determining output temperature data based on the first data and output metadata based on the metadata; and

presenting the output metadata and the output temperature data on a display device.

26. The apparatus of claim 25, the at least one memory and the one or more sequences of instructions are further configured to, with the at least one processor, cause the system to perform at least the following:

receiving from the radio transceiver second data comprising: the second data is based on a corresponding plurality of position measurements at a plurality of different position times from a global positioning receiver in contact with a container configured to hold an aqueous solution and the anatomical organ;

storing the second data in the at least one memory in association with the metadata of the anatomical organ;

determining output location data based on the second data; and

Presenting the output location data on a display device.

27. The apparatus of claim 25, the at least one memory and the one or more sequences of instructions are further configured to, with the at least one processor, cause the system to perform at least the following:

receiving patient data indicative of an electronic medical record of a recipient of the anatomical organ;

storing the patient data in the at least one memory in association with the metadata of the anatomical organ;

determining output patient data based on the electronic medical record of the subject; and

presenting the output patient data on a display device.

Background

There is a great difference between the number of americans on the transplant waiting list and the number of organs available for transplantation. Indeed, in the united states, as many as 20 people die each day, awaiting a lifesaving organ. To utilize each available organ, patients, physicians, and other healthcare professionals in the united states use an Organ Procurement and Transplantation Network (OPTN) organized and managed by an organ sharing federation network (UNOS).

UNOS is a non-profit tissue located in rieston, virginia, with the purpose of assisting and facilitating the organ transplantation and donation process. In addition to managing a transplant waiting list of countries, maintaining a database of all transplant events occurring in the united states and providing assistance to patients and family members; the UNOS also makes policies and procedures for the migration process.

A fundamental aspect in improving the organ transplant process is the transportation, storage and monitoring of compact and renewed organs. Kidneys are the most common transplanted organ in the united states, but there are too few kidneys to meet the needs of the kidneys on the transplant waiting list. Extensive work has been done to determine the optimal use of kidneys available for transplantation. Until 2014, transplantation professionals conducted 12 years of research, and the results showed that too many patients on the kidney transplant waiting list died.

In addition, individual patient populations, particularly patients with poor immunological characteristics, vary in the manner in which the transplant is obtained. Thus, complex mathematical models indicate that increasing organ sharing at the national level can partially solve this problem. Thus, UNOS changed the dispensing system, particularly for the kidneys, and these changes were effected 12 months and 4 days in 2014. These changes allow for better immunological matching of donor recipients, thereby increasing the number of potential transplants. Sharing organs nationwide has become more common after KAS updates. After the new kidney distribution system was adopted, the proportion of kidneys shared nationwide (rather than remaining in place) increased by more than 40% (see table 1). Indeed, while only 20% of the kidneys were shared prior to renewal, more than 33% of the organs are now shared between organ procurement tissues (OPOs).

Although the new dispensing system has been shown to improve the chances of performing a transplant, the distance between the donor and recipient has also increased. For example, the distance covered by a typical kidney transplant increases on average from 197 miles to 267 miles; in some cases, the distance covered increases from 440 miles to 706 miles — a 60% increase in mileage. Longer distances naturally result in longer transport times. In medical terms, the time it takes for an organ to cool after a blood supply is reduced or cut off and warm by restoring the blood supply is called Cold Ischemia Time (CIT).

CIT is a significant predictor of long-term survival of patients and kidneys. Elevated CIT can lead to a problem known as delayed return of transplanted kidney function (DGF), where the kidney may not function immediately after transplantation. The mean CIT rises so that now, over 24 hours later, over 22% of the kidneys are transplanted. This is important because 24 hours is the accepted "upper limit" for CIT. Thus, the proportion of DGF in renal receptors also increases from 25% to 31%, resulting in a corresponding number of kidneys not acting immediately. Although DGF is treatable, the cost of treatment is prohibitive, with the cost per transplant procedure increasing by as much as $ 100,000 to $ 250,000 depending on the extent of DGF (the total annual cost of a country exceeds $ 8 billion). A more efficient method for organ trafficking may not only improve the chances of acquiring a transplant, but may also reverse the trend of CIT and DGF to pre-KAS levels.

TABLE 1 altered organ geographic sharing based on the U.S. Kidney Assignment System (KAS)

Another important factor in organ transport is the risk to the organ transplant personnel. In a recent study of over 2,000 procurement of abdominal and thoracic organ grafts, researchers observed that recovery groups typically took 550-. Furthermore, it is well known that routes are associated with increased risk of accidents. Indeed, a tragedy recently occurring in michigan resulted in 6 deaths (4 members of the medical team and 2 pilots) who were on the way to a life-saving lung transplant procedure. A team in michigan had a small 8-seat fixed wing aircraft in the event of a crash. Even before newly introduced distribution systems and associated CIT growth, the typical kidney distance is about 200 miles, and thus the transport crew is required to travel more. Given that surgical personnel on light aircraft (typically on small fixed wing proprotor aircraft and helicopters) are often at risk of car crashes and high risk trips at night, it remains important to eliminate these trip risks for pilots and surgical recovery personnel, but the need in the field of transplantation has not yet been met.

Although many kidneys are transported by commercial travel, this is an inadequate solution. Typically, civil aviation schedules and travel times are not consistent with optimal organ delivery times. Thus, the use of commercial flights is not sufficient to meet the needs of the transplant professionals. The experience of the signer is that life-saving organs are often rejected for transplantation, since the target organ will result in a significantly prolonged CIT due to the schedule of the commercial airline.

In addition, the current cost of organ procurement is very high. Recently, the signed inventors participated in donor liver transplantation surgery from texas. To get donor livers to the transplantation center in maryland requires a personal airplane rental at $ 80,000. In a similar situation, the transplantation center in maryland generates a shipping cost of approximately $ 3 million due to the bag purchase of life-saving kidney-pancreas combination transplants. The average cost of transplantable kidneys is about $ 40,000, a large portion of which is transportation costs. Thus, the U.S. costs more than $ 6.8 million per year on transplantable kidneys.

In addition, during transport and manipulation, organs are subjected to a number of unique environmental conditions and changes that affect the viability and viability of the organ. For example, variations in vibration, pressure and temperature can affect organ tissue and determine whether the organ is suitable for transplantation after it reaches its destination. Moreover, since there is little or no record of organ exposure conditions, these conditions and changes are often not found by the transplant personnel.

Disclosure of Invention

Significant improvements in mitigating CIT can be achieved using unmanned aerial vehicle systems (UAS) for organ transport, thereby increasing the availability of transplantable organs. Potential improvements in organ quality, resulting from accelerated motion, can improve organ utilization, reduce the number of discarded organs, increase the number of transplantable, non-vital organs that might otherwise be discarded, and improve the transplant outcome of organ transplantation. UAS organ transport represents a potentially large opportunity in the field of transplantation. By monitoring unique environmental conditions and changes that affect organ viability and viability, techniques are provided that utilize UAS and other advanced levels of technology in organ trafficking.

Techniques for monitoring and transporting anatomical organs are provided. These techniques include the use of a sleeve that is placed tightly around the organ and includes a porous material for the aqueous solution. In some embodiments, the sleeve cooperates with a container attached to a high-end vehicle, such as an unmanned aerial vehicle. In some embodiments, the cartridge is sterile.

In a first set of embodiments, the sleeve is shaped to approximate the shape of the target anatomical organ and has an opening for insertion of the target anatomical organ, the sleeve comprising a fabric that is porous to aqueous solutions and has a tensile strength for retaining the weight of the sleeve and the target anatomical organ.

In some embodiments of the first set, the fabric of the sleeve may further comprise a second, different opening for passage of a blood vessel of the target anatomical organ. Further, the sleeve may be shaped to closely fit and envelope the anatomical organ. Still further, the fabric may be easily cut with surgical scissors to access anatomical organs. In a first set of other embodiments, the sleeve may further comprise at least one of a temperature sensor and a vibration sensor attached to the fabric of the sleeve.

In a second set of embodiments, a system for monitoring and transporting an anatomical organ comprises: a sleeve shaped to approximate the shape of the target anatomical organ, the sleeve comprising an opening for insertion of the target anatomical organ and a fabric that is porous to aqueous solutions and has a tensile strength for maintaining the weight of the sleeve and the target anatomical organ; and a container for holding the aqueous solution, the sleeve and the anatomical organ. Further, the system includes a temperature sensor in thermal contact with the sleeve when the sleeve is positioned inside the container. In some embodiments, the temperature sensor produces a corresponding plurality of temperature measurements at each time. In yet another embodiment, the system includes a wireless communication device in signal communication with the temperature sensor. Still further, the wireless communication device may transmit the first data based on the corresponding plurality of temperature measurements at the respective times.

In some embodiments of the second set, the fabric of the sleeve may further include a second, different opening for passage of a blood vessel of the target anatomical organ. Further, the sleeve may be shaped to closely fit and envelope the anatomical organ. Still further, the fabric may be easily cut with surgical scissors to access anatomical organs.

Furthermore, in other embodiments of the second group, the temperature sensor may be attached to the fabric of the sleeve. In yet another embodiment, a temperature sensor may be attached to the container.

In some other embodiments of the second group, the system includes a vibration sensor in mechanical contact with the sleeve when the sleeve is inside the container and in signal communication with the wireless communication device. In some embodiments, the vibration sensor produces a corresponding plurality of vibration measurements at each time. Further, the wireless communication device may transmit second data based on the corresponding vibration measurements at the respective times. Further, the vibration sensor may be attached to the fabric of the sleeve. In yet another embodiment, the vibration sensor may be attached to the container.

In yet other embodiments of the second group, the system includes a global positioning system receiver for generating a plurality of position measurements at different times. In addition, a global positioning system receiver is in signal communication with the wireless communication device. Still further, the wireless communication device may transmit second data based on the corresponding plurality of location measurements at the respective times. In other embodiments, a global positioning system receiver may be attached to the container.

Further, in a second set of other embodiments, the system includes an air pressure sensor for generating a plurality of air pressure measurements at different times. Further, the air pressure sensor is in signal communication with the wireless communication device. Still further, the wireless communication device may transmit second data based on the corresponding plurality of barometric pressure measurements at the respective times. In other embodiments, the vibration sensor may be attached to the container.

Additionally, in a second set of other embodiments, the system includes a processor and at least one memory having one or more sequences of instructions, wherein execution of the one or more sequences of instructions included in the at least one memory by the processor causes the system to receive a plurality of measurements from the temperature sensor and determine first data, store the first data in the at least one memory, and transmit the first data using the wireless communication device.

In a third set of embodiments, an apparatus comprises: a radio transceiver, at least one processor, and at least one memory including one or more sequences of instructions; wherein execution of one or more sequences of instructions contained in the at least one memory by the at least one processor causes the apparatus to: receiving metadata indicative of an anatomical organ; receiving from the radio transceiver first data: the first data is based on a plurality of temperature measurements taken at different times from a temperature sensor in thermal contact with an anatomical organ located inside a container holding an aqueous solution; storing the first data in association with metadata of the anatomical organ in at least one memory; determining output temperature data based on the first data, and determining output metadata based on the metadata; and presenting the output metadata and the output temperature data on a display device.

In some embodiments of the third group, execution of one or more sequences of instructions contained in the at least one memory by the at least one processor causes the apparatus to: receiving the following second data from the radio transceiver: the second data is based on a plurality of position measurements taken at different times from a global positioning receiver system in contact with a container configured to hold an aqueous solution and an anatomical organ; storing the second data in the at least one memory in association with metadata of the anatomical organ; determining output position data based on the second data; and presenting the output location data on a display device.

In a third set of further embodiments, execution of one or more sequences of instructions contained in the at least one memory by the at least one processor causes the apparatus to: receiving patient data indicative of an electronic medical record of a transplant recipient of an anatomical organ; storing patient data in at least one memory in association with metadata of an anatomical organ; determining output patient data based on an electronic medical record for the transplant recipient; and presenting the output patient data on a display device.

Other aspects, features and advantages will be apparent from the following detailed description, simply by illustrating many specific embodiments and implementations, including the best mode contemplated for carrying out the present invention. Other embodiments can have other and different features and advantages, and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Drawings

Embodiments are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

FIG. 1 is a drawing illustrating an example of a sleeve for monitoring and transporting an anatomical organ, according to one embodiment;

FIG. 2 is a photograph showing an example of inserting the sleeve of FIG. 1 to a container to be shipped, according to one embodiment;

3A-3C are pictorial diagrams illustrating various views of an example of the sleeve shown in FIG. 5, in accordance with one embodiment;

FIG. 4 is a block diagram illustrating an anatomical organ sleeve according to one embodiment;

Fig. 5A is a block diagram illustrating a system for monitoring and transporting an anatomical organ, in which at least one of a temperature sensor, a vibration sensor, a barometric pressure sensor, a global positioning system receiver, and a wireless communication device are located inside a container but no sensor is attached to a sleeve, according to one embodiment;

fig. 5B is a block diagram illustrating a system for monitoring and transporting an anatomical organ, in accordance with one embodiment, wherein at least one of a temperature sensor, a vibration sensor, a barometric pressure sensor, a global positioning system receiver, and a wireless communication device are located inside the container and at least one of the sensors is attached to the sleeve;

FIG. 6 is a block diagram illustrating a system for monitoring and transporting an anatomical organ, wherein no sensors are located inside the container, according to one embodiment;

7A-7C are photographs illustrating an example of the container shown in FIG. 6, according to one embodiment;

figure 8 is a block diagram illustrating a system for monitoring and transporting an anatomical organ with a UAV, according to one embodiment;

figure 9 is a block diagram illustrating a system for monitoring and transporting an anatomical organ with a UAV, according to one embodiment;

FIG. 10 is a flow diagram illustrating a method of transmitting temperature measurements using the systems shown in FIGS. 5-9, according to one embodiment;

FIG. 11 is a flow diagram illustrating a method of receiving and displaying data corresponding to an anatomical organ, according to one embodiment;

12A-12B are diagrams illustrating anatomical organ conditions stored and transmitted from temperature sensors and vibration sensors during UAV flight according to embodiments;

13A-13B are diagrams illustrating anatomical organ conditions stored and transmitted from altitude and vibration sensors during UAV flight experiencing rapid ascent and descent, according to an embodiment;

14A-14C are diagrams illustrating anatomical organ conditions stored and transmitted from a vibration sensor, a global positioning system receiver, and an altitude sensor in multiple UAV flights according to embodiments;

FIG. 15 is a diagram illustrating anatomical organ conditions stored and transmitted from vibration sensors during a piloted fixed wing jet dynamic flight in accordance with an embodiment;

FIG. 16 illustrates a chipset that may implement a portion of an embodiment of the invention; and

FIG. 17 is a diagram of example components of a mobile terminal (e.g., handset) for communications, according to one embodiment.

Detailed Description

Apparatus and methods for monitoring and transporting an anatomical organ within a sleeve are described. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to avoid unnecessarily obscuring the present invention.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope are approximations, the numerical values set forth in the specific non-limiting examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements at the time of writing. Furthermore, unless otherwise clear from the context, the numerical values given herein have the implied precision given by the least significant digit. Thus, a value of 1.1 represents a value from 1.05 to 1.15. The term "about" is used to indicate a broad range centered on a given value and, unless otherwise clear from the context, indicates a broad range around the least significant digit, such as "about 1.1" indicates a range from 1.0 to 1.2. The term "about" means twice if the least significant figure is unclear, e.g., "about X" means a value in the range of 0.5X to 2X, e.g., about 100 means a value in the range of 50 to 200. Moreover, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of "less than 10" for only the positive parameter may include any and all subranges between (including) the minimum value of 0 and the maximum value of 10, i.e., any and all subranges having a minimum value equal to or greater than 0 and a maximum value of equal to or less than 10, e.g., 1 to 4.

Some embodiments of the invention are described below in the context of kidney transplantation for transport over an Unmanned Aerial System (UAS). However, the present invention is not limited to this context. In other embodiments, the other organ may be a target anatomical organ. For example, some embodiments may include, as non-limiting examples, the heart, lungs, spleen, pancreas, and the like. It should also be noted that the present invention is not limited to human organs. In other embodiments, the organ from the animal may be a target anatomical organ. In other embodiments, the organ is transported on other vehicles, such as manned aircraft, manned or unmanned land or sea vehicles, or underground vehicles.

1. Overview

Fig. 1 is a pictorial diagram illustrating an example of a sleeve assembly 100 for monitoring and transporting an anatomical organ 190, in accordance with one embodiment. In accordance with the illustrated embodiment, sleeve assembly 100 includes a sleeve 101, which sleeve 101 tightly-as shown-or loosely encloses a cavity shaped to approximate the shape of the targeted anatomical organ 190. In this context, tight means surrounding the target organ without gaps and with a sufficiently maintained fit that the organ does not slip uncontrollably relative to the sleeve when the sleeve is held by hand. In some embodiments, sleeve 101 does not approximate the shape of anatomical organ 190 at all, rather, sleeve 101 largely surrounds and encloses anatomical organ 190. The sleeve 101 has a first opening 102 configured for inserting the target anatomical organ 190 into a cavity of the sleeve. In some embodiments, the first opening 102 is resealable. Sleeve 101 is made of the following fabric: the fabric is porous to aqueous solutions and has sufficient tensile strength to maintain the weight of sleeve assembly 100 and the weight of target anatomical organ 190. It would also be advantageous if the fabric were sterilizable and did not damage the attached organ that was in contact with the organ. Any fabric that meets these requirements can be used and can be readily found by routine experimentation. An example fabric includes cotton. In some embodiments, chloroprene (which is known to be sterilizable and safe for contact with the kidneys and other organs) and other synthetic fabrics are used, and may be synthesized with pores that allow preservative solution to penetrate the fabric. In embodiments where the sleeve is loosely fitted, the sleeve material may allow the preservative fluid to circulate inside the sleeve, and the fabric of the sleeve need not be porous.

In another embodiment, sleeve 101 is made of an impermeable fabric that contains an aqueous solution. As will be appreciated by those skilled in the art, the term "fabric" as used herein may also include materials produced by processes other than weaving of threads, such as vulcanization or extrusion. In a non-limiting example, the sleeve 101 is a resealable polypropylene bag.

For illustrative purposes, the target anatomical organ 190 is depicted as fitting closely into the lumen of the sleeve 101, but the anatomical organ 190 is not part of the sleeve 101 or assembly 100. For illustrative purposes, the target anatomical organ 190 is depicted in the illustrated embodiment as a single human kidney; however, in other embodiments, sleeve 101 is shaped to enclose a different organ, such as a lung, heart, pancreas, liver, eye, etc., within a cavity that is a target anatomical organ of a human or non-human organism.

The fit, whether tight or loose, with the anatomical organ allows the sleeve to be grasped and held by a worker, such as a transporter, nurse, or surgeon, without damaging or losing the anatomical organ inside the sleeve during transport or during a transplant procedure. The fabric is porous to the aqueous solution so that when the organ is located inside the sleeve and the sleeve is immersed in the preservative solution, the preservative solution for maintaining the organ in a state suitable for transplantation can come into contact with the organ. Any preservative solution known in the art may be used, such as university of wisconsin solution (UW solution), histidine-tryptophan-ketoglutarate solution (HTK solution), Euro-Collins solution, and static preservative solution (SPS-1).

In some embodiments, the sleeve includes a different second opening 103. The second opening is positioned relative to the first opening and is sized such that one or more anatomical portions, such as veins, arteries, and nerves (e.g., portal veins for the kidney) surgically attached to the patient during transplantation can be fed through the second opening and surgically attached to the recipient subject while the anatomical organ 190 remains inside the lumen of the sleeve 101. This helps the surgical personnel to hold the anatomical organ during the attachment process. After the anatomical portion is attached, the sleeve may be removed after shearing the sleeve on the path between the first opening 102 and the second opening 103. In such embodiments, it is advantageous for the fabric of the sleeve to have the following characteristics: at least on the path between the first opening 102 and the second opening 103, it can be easily cut with surgical scissors commonly used in transplantation operative sites. Thus, the sleeve may be used not only during transport, but also during attachment.

In some embodiments, the sleeve further includes one or more sensors 110 that can be used to track the condition of the organ during transport. Example sensors include one or more of: a temperature sensor, an immersion sensor for ensuring that the sleeve and any organ inside have been immersed in the preservative solution, a vibration sensor for tracking any possible destructive vibrations or pressures to which the sleeve and any organ inside are subjected, an accelerometer for tracking any possible destructive movements or directions to which the sleeve and any organ inside are subjected. In various embodiments, the one or more sensors 110 contact the exterior of the sleeve, are embedded in the fabric of the sleeve, or penetrate to the surface of the lumen inside the sleeve to contact any anatomical organ inside the lumen of the sleeve. In any of these embodiments, the sensor terminates in a connection terminal on the outer surface or exterior of the sleeve for later connection to a power source or information communication link or some combination.

In some embodiments, sleeve assembly 100 includes a dip-proof electronics module housing 120 attached to an outer surface of sleeve 101. The housing encloses electronics for powering one or more sensors 110, or operating one or more sensors 110, or receiving or transmitting data from one or more sensors 110, or some combination. In some embodiments, the electronic device comprises: a power source; one or more sensors that do not require contact with the organ or sleeve, such as sensors for air pressure, humidity, ambient air or preservative fluid temperature, inertial measurements, geographic location (e.g., global positioning system GPS receiver); or the electronics include electronics for data multiplexing, data conditioning/preprocessing, storage, retrieval, or communication with a local or remote processor; or the electronic device may comprise some combination. In some embodiments, the electronics module housing 120 includes a port or cable (not shown) for attachment to some external system such as a power supply, processor, or communications module, or some combination. In other embodiments, the sensor may be placed outside of a sterile sleeve or bag containing the anatomical organ. In some other embodiments, however, the sensor is also placed in a sterile enclosure, either together with or separately from the anatomical organ.

Fig. 2 is a photograph showing an example of a container for placement of the sleeve system 100 of fig. 1 for transport, according to one embodiment. The sleeve system 100 comprises at least a sleeve 101. The container is configured to hold the preservative fluid and sleeve 101 during transport in a vehicle, such as on an unmanned aerial vehicle (UAS). The container is also configured for thermal insulation to help stabilize the temperature of the preservative fluid and organs to fall within an acceptable transport temperature range with or without heating or refrigeration. Example ranges of acceptable shipping temperatures include a range from-2 degrees celsius to 10 degrees celsius. In non-limiting embodiments, the container is further configured to withstand forces and pressures in the range between 0 to 5g and 0 to 10kPa, respectively. The container includes an opening for insertion of the sleeve 101 or the system 100 and any organs inside the sleeve into the container. In some embodiments, the container includes a lid configured to remain in place and prevent leakage of the sleeve system 100 or sleeve 101 or preservation fluid during transport, such as during a hazardous flight that may invert the container. For example, one embodiment of the container is a standard carton enclosing a polystyrene foam insulation box.

In some embodiments, the container includes additional electronic or optical modules, such as: a display device for presenting a current or cumulative or extreme value generated by any sensor or some combination; additional sensors, such as height radar or laser sensors that provide distance to the ground or other obstacles; or one or more sensors that would otherwise be located in the electronics module housing 120 as described above; or some combination. In some embodiments, the container includes a cable or port on an inner or outer surface of the container configured as a complementary terminal for connecting to a connection terminal of any sensor 110 or electronics module 120 attached to the sleeve 100, or to any system external to the container but on the same transport vehicle.

Fig. 3A-3B are pictorial diagrams illustrating various views of an example of the sleeve assembly shown in fig. 1, according to one embodiment. The depicted sleeve assembly includes a sleeve 301 and an electronics module housing 320, the electronics module housing 320 having a power cord and communication link 321 and two sensor links 312, the two sensor links 312 extending outside the housing 320 and connecting to the temperature and vibration sensor 310. As shown in fig. 3B, electronics module housing mount 322 is attached to the fabric of sleeve 301 and is configured to attach and seal to electronics module housing 320.

The organ sleeve or "Koozi" 301 is a flexible, permeable and disposable sleeve that ensures firm contact of the sensor with the organ in the sleeve by light pressure. According to the illustrated embodiment, the organ sleeve is formed of polyester-covered neoprene foam. The sleeve is configured to conform to the size and shape of an average human kidney; and has a single hole to allow insertion of the organ and free movement of the underlying fluid conduit (e.g., vasculature and ureters). The elasticity of the neoprene and polyester fabric coatings allows for the desired compression required for mechanical coupling of the sensor modules. The open cell structure of neoprene and porous polyester allows fluid and nutrients to be transported from the external solution through the sleeve wall. The sleeve 301 shown is made of a fabric coated neoprene construction, custom cut, and sealed with neoprene contact cement. The sleeve 301 is shown having a custom designed shape and size to fit the kidney of an average person.

As shown in fig. 3C, the illustrated sleeve assembly further includes a custom electronics system designed and assembled to allow continuous monitoring, recording and transmission of temperature and vibration data acquired at the organ surface. Electronic device packages are developed to minimize size, weight, and power requirements while remaining modular for flexibility and future upgrades. The system and apparatus are configured as stable electronics and sensor units and enable external power and communication interfaces using a custom water-proof housing. The electronics and sensor unit includes a 4-level vertical stack with 3 commercial components and 1 custom component. The electronics unit includes a processing stack having a microprocessor unit, an inertial measurement unit, and a data recording unit. The electronics stack also includes a communication connection for a 100 kiloohm (kOhm) NTC thermistor and a thermistor measurement circuit. Data transmission is accomplished by serial communication via a 4-wire waterproof cable leading to the data transmission module. The illustrated embodiment is powered by a lithium ion battery included in a custom housing that serves as the electronics module housing 320. In the illustrated embodiment, the housing 320 is a custom-made 3D printed enclosure for contacting human organs in a waterproof manner during transport. Electronics 324 includes a sensor stack that includes a microcontroller, an SD card unit, an accelerometer (vibration) unit, and thermistor circuitry on circuit board 325. The link 312 connects the electronics 324 to the thermistor and vibration sensor 310. The power of the device is controlled by an externally accessible IP68 rated (dustproof, waterproof) power switch 326. The LiPo battery 327 provides power for the independent functions of the electronic device 324. The housing includes a custom-made enclosure cover 321, the enclosure cover 321 providing a seal to keep the preservative fluid out of the electronic device 324.

Fig. 4 is a block diagram illustrating an example sleeve assembly 400 for transport of an anatomical organ, according to one embodiment. The assembly 400 includes a sleeve 401 having a cavity 404, the cavity 404 configured to conform to an anatomical organ. In the illustrated embodiment, the assembly 400 includes a temperature sensor 420 and a vibration sensor 430 in thermal and mechanical contact with the sleeve 401 or cavity 404, respectively.

Fig. 5A is a block diagram illustrating a system 500 for monitoring and transporting a target anatomical organ 510, according to one embodiment. The system 500 includes a sleeve 520, a container 530, a temperature sensor 540, and a wireless communication device 550 disposed inside the container 530. In embodiments, the temperature sensor 540 may be detachable from the fabric of the sleeve 520, as shown in fig. 5A, or attached to the fabric of the sleeve 520, as shown in fig. 5B.

In an embodiment, sleeve 520 includes a first opening for insertion of target anatomical organ 510. Although organ 510 is included for purposes of illustrating operation, organ 510 is not part of sleeve 520 or system 500. In another embodiment, sleeve 520 may tightly surround target anatomical organ 510 without exerting so much pressure that anatomical organ 510 is compressed, but sleeve 520 is not so loose that anatomical organ 510 may freely displace and move relative to sleeve 520. In a non-limiting embodiment, the sleeve 520 may include a fabric that is porous to the aqueous solution 531. In a non-limiting example, the fabric may be neoprene. However, the fabric need only be porous with respect to the aqueous solution 531, and the particular material is not limiting. In some embodiments, the material has sufficient tensile strength to maintain the weight of the sleeve and the weight of the targeted anatomical organ 510. In yet another embodiment, the fabric may be easily cut with at least one of scissors, and a scalpel. Additionally, in other embodiments, the fabric may be easily removed by hand. In some other embodiments, the sleeve 520 may have a second opening. Further, the second opening may be used to pass a vessel (such as a blood vessel or ureter) of the targeted anatomical organ 510.

It will be understood by those skilled in the art that the term "anatomical organ" is intended to be non-limiting and may be any organ capable of being transported or transplanted. As non-limiting examples, anatomical organ 510 may be a human kidney, a human heart, a human lung, a human spleen, and a human pancreas. It is also understood that anatomical organ 510 can also be any organ belonging to an animal that can be transported or transplanted.

Returning to fig. 5A, in some embodiments, the sleeve 520 holding the anatomical organ 510, the temperature sensor 540, and the wireless communication device 550 may be placed in an aqueous solution 531 within a container 530. Further, the temperature sensor 520 may be in thermal contact with the sleeve 520 when the sleeve 520 is positioned inside the container 530. In other embodiments, such as the non-limiting embodiment shown in fig. 5B, the temperature sensor 540 may be attached to the fabric of the sleeve 520 when the sleeve 520 is placed in the aqueous solution 531 contained within the container 530.

In yet another embodiment, the temperature sensor 540 may acquire a plurality of temperature measurements periodically or after an event. Further, the temperature sensor 540 may communicate with the wireless communication device 550 to wirelessly transmit first data based on a plurality of temperature measurements acquired by the temperature sensor 540.

Returning to fig. 5A, in some other implementations, the system 500 may include at least one of a vibration sensor 560, a global positioning system receiver 570, and a pressure sensor 580 in communication with the wireless communication device 550. In an embodiment, at least one of the vibration sensor 560, the global positioning system receiver 570, and the pressure sensor 580, as well as the sleeve 520 housing the anatomical organ 510, the temperature sensor 540, and the wireless communication device 550, may be placed in the aqueous solution 531 within the container 530.

In an embodiment, the vibration sensor 560 may acquire a plurality of vibration measurements periodically or after an event and wirelessly transmit second data based on the plurality of vibration measurements by communicating with a plurality of wireless communication devices. In other embodiments, the vibration sensor 560 may be detachable from the sleeve 520, as shown in FIG. 5A, or in mechanical contact with the sleeve 520, as shown in FIG. 5B. In some other embodiments, the vibration sensor 560 may be attached to the fabric of the sleeve 520.

Returning to fig. 5A, in some embodiments, the global positioning system receiver 570 may generate a plurality of position measurements periodically or after an event, and wirelessly transmit second data based on the plurality of position measurements by communicating with the wireless communication device Bx 70.

In an embodiment, barometric pressure sensor 580 may generate a plurality of barometric pressure measurements periodically or after an event, and wirelessly transmit second data based on the plurality of barometric pressure measurements by communicating with wireless communication device Bx 70.

Fig. 6 is a block diagram illustrating a system 600 for monitoring and transporting a target anatomical organ 610, according to one embodiment. Fig. 6 is the same as fig. 5A except that temperature sensor 640, wireless communication device 650, vibration sensor 660, global positioning system 670, and air pressure sensor 680 are located outside of container 630. In another implementation, at least one of the temperature sensor 640, the wireless communication device 650, the vibration sensor 660, the global positioning system 670, and the air pressure sensor 680 is not attached to the container 630.

Fig. 7A to 7B are photographs illustrating an example of the container shown in fig. 6 according to an embodiment. Fig. 7B shows the sleeve 620 inside the container 630, while the wireless communication device 650 and the global positioning system 670 are attached to the outside of the container 630-as shown in fig. 7C.

Fig. 8 is a block diagram illustrating a system 800 for monitoring and transporting an anatomical organ 810 with a UAV 890 according to one embodiment. The system 800 includes a container 830, a temperature sensor 840, at least one of a vibration sensor 860 and a gas pressure 880, and a UAV 890. In an embodiment, a sleeve 820 containing an anatomical organ 810 is placed inside a container 830. Further, the container 830 is mechanically attached to a UAV 890. In another embodiment, UAV 890 includes a wireless communication device 850. Further, UAV 890 may include a global positioning system receiver 870 in communication with wireless receiver 850. Further, the wireless communication device 850 may receive third data related to control and guidance of the UAV 890.

In yet another embodiment, the temperature sensor 840 may acquire a plurality of temperature measurements periodically or after an event and transmit first data based on the plurality of temperature measurements by communicating with the wireless communication receiver 850. In other implementations, at least one of the vibration sensor 860 and the barometric pressure 880 may acquire a plurality of vibration measurements and a plurality of barometric pressure measurements, respectively, periodically or after an event, and transmit second data based on at least one of the plurality of vibration measurements and the plurality of barometric pressure measurements by communicating with the wireless communication device 850. In other embodiments, at least one of the temperature sensor 840, and the vibration sensor 860 and the air pressure sensor 880 may or may not be attached to the container 830.

Fig. 9 is a block diagram illustrating a system 900 for monitoring and transporting an anatomical organ 910 with a UAV according to one embodiment, the system 900 being similar to the system 800 except that a temperature sensor 940, and at least one of a vibration sensor 960 and a barometric pressure sensor 980 are housed within a container 930 and may or may not be attached to the sleeve 920.

Although the processes, devices, and data structures are depicted in fig. 4-6 and 7-9 as unitary blocks in a particular arrangement for purposes of illustration, in other embodiments one or more processes or data structures or portions thereof are arranged differently on the same or different hosts, in one or more databases, or are omitted, or one or more different processes or data structures are included on the same or different hosts.

Fig. 10 is a flow chart illustrating a method of transmitting temperature measurements using the systems described in fig. 5-9, according to one embodiment. The system 500 includes at least one processor and at least one memory having one or more sequences of instructions. In step 1003, the processor receives a plurality of temperature measurements from the temperature sensor. Then, in step 1005, the processor determines first data based on the plurality of temperature measurements from the temperature sensor. In step 1007, the processor stores the first data in the at least one memory and in step 1009, the processor transmits the first data using the wireless communication device 550. If the transmission period indicates that no more first data is available, or the event ends, the wireless communication device 550 ends the transmission in step 1013. If more data is available, the process starts again.

FIG. 11 is a flow diagram illustrating a method 1101 of receiving and displaying data corresponding to an anatomical organ using the system described in FIG. 17, according to one embodiment. The mobile terminal 1701 includes a radio transceiver 1715, at least one processor 1705, at least one memory 1751, and a display 1707. Fig. 17 will be discussed in more detail below.

Returning to fig. 11, in step 1103, the processor 1705 receives metadata indicative of the anatomical organ from the radio transceiver 1715. In an exemplary embodiment, the anatomical embodiment may be the anatomical organ 190 shown in fig. 1. Next, in step 1105, the processor 1705 receives first data from the radio transceiver 1715. The first data may include a plurality of temperature, vibration, inertia, barometric pressure, or position measurements corresponding to different measurement times. In an embodiment, the first data comprises temperature measurements corresponding to data reported by a temperature sensor in thermal contact with an anatomical organ inside a container configured to hold the aqueous solution. In step 1107, the processor 1705 stores the first data in association with metadata indicative of the anatomical organ in at least one memory 1751.

Then, in step 1109, the processor 1705 determines an output temperature based on the first data and determines output metadata based on the received metadata indicative of the anatomical organ. In step 11011, the processor 1705 presents the output metadata and the output temperature data to the user using the display device 1707. If an event occurs indicating that the first data or metadata is over, the process ends and no new output metadata or output temperature data is updated. If more data is available, the process starts again.

Although the steps are depicted in fig. 10 and 11 as a whole in a particular order for purposes of illustration, in other embodiments one or more steps or portions thereof are performed in a different order, or overlapping in time, performed in series or in parallel, or omitted, or one or more additional steps are added, or the method is altered in some combination.

2. Example embodiments

The HOMAL (human organ monitoring and quality assurance device for long distance travel (HOMAL; patent application)) is the following embodiment: the embodiment is configured to measure temperature, barometric pressure, altitude, vibration, and location via the Global Positioning System (GPS) during transportation, as described above. These parameters are chosen because they are considered important during the transportation of the UAS without stress. But other parameters, equally important but not mentioned herein, may capture the conditions and forces to which the anatomical organ is subjected during a non-stressed UAS. In an experimental example embodiment of HOMAL, the human kidney was used as an example anatomical organ.

Experimental HOMAL includes a neoprene exoskeleton gently enveloping the kidneys. Embedded in the exoskeleton are biosensors that measure each of the desired parameters in real time. These data are streamed to the land-based server every 10 seconds using wireless technology. The server data will then automatically populate an "organ transplant monitoring system" or OTMS which is an application ("app") accessible on any standard internet-based device (e.g., mobile phone, computer, etc.). In some embodiments, the system includes an app running on an internet appliance.

HOCAL communicates with a Smart Cooler (Smart Cooler) as the container. The smart cooler has a Graphical User Interface (GUI) that allows the user to observe, for example, real-time temperature, acceleration, altitude, barometric pressure, vibration intensity (relative to frequency), latitude, longitude, battery life of the smart cooler, and wireless signal strength.

The renal donor tested was a 57 year old african american male who had a history of HTN, alcoholism, and splenectomy surgery in the past. The renal donor profile index (KDPI) is 70%, and donors harbor Cytomegalovirus (CMV) + and increase social risk for Public Health Services (PHS). The donor was non-oliguric and was brain dead. Admission creatinine was 0.9mg/dL, peak creatinine was 0.9mg/dL, and terminal creatinine was 0.5 mg/dL. On recovery, scar tissue is present between the left kidney and the pancreas tail, suggesting pancreatitis was previously present.

The kidneys reached a box measuring 27.9cm x 38.1cm x 22.86 cm. The weight of the transport box, including transport containers/materials, University of Wisconsin (UW) solution and organs, was 5.1 kg. The kidneys were not injured and normal in appearance. Organs were stored in UW solution. Kidneys fail to be placed nationwide and are therefore offered for study. The total cold ischemia time (CIT, which is the time period between organ implantation and implantation during which the organ is cooled-in some cases, the organ is cooled to 4 degrees celsius on ice-and this time period is limited if the tissue or organ is to be transplanted) is 19.0 hours at the time of dispensing. The total CIT ("open box") before UAS testing was 63.3 hours. The kidneys were shipped to our laboratory by a series of couriers and commercial aircraft, 1060 miles away. Kidneys were refrigerated in UW solution for overall transport and testing. No kidney damage occurred during transport.

The kidney is 11cm by 5 cm. There is one artery, one vein and one ureter. Aortic and arterial plaques were present. Post-recovery renal biopsy performed prior to shipment indicated that glomerulosclerosis accounted for 12%. Biopsies also indicate focal, mild interstitial fibrosis, and focal, mild arterial and arteriolar lesions.

Since additional CIT passed between distribution and testing, the kidneys were biopsied immediately prior to UAV testing. A third biopsy was taken of the organ after 4.5 hours of testing (including 1 hour of 2 minutes UAV flight). Biopsies were stored in formalin and fixed in paraffin blocks. Hematoxylin and eosin (H & E) were stained and the results were interpreted by an advanced kidney transplant pathologist at the university of maryland.

The organ is measured with two thermometers. The HOMAL thermistor has a silica gel for improved efficacy in conducting solutions. The core temperatures of the kidney, ambient air and UW solution were measured using a second digital meat thermometer (bradshaww international, Rancho Cucamonga, california). The second thermometer has a double protective sleeve and an anti-slip silicone tip for puncturing the kidney. The manufacturer of the second thermometer tests in the range of-50 degrees celsius to 300 degrees celsius. The second digital thermometer was powered by a single L1154 alkaline battery. The manufacturer's specifications indicate that temperature equilibration takes 20 seconds. In this study, the wait time was greater than 30 seconds to ensure accurate measurements. Meat thermometers allow the correlation of temperature to be measured by HOMAL. All temperature measurements were made five times and 30 seconds apart. This is done to understand the variability of each device and to improve accuracy. HOMAL-derived barometric data in millibar (1 millibar) Bar 10 kPa) were quantified. The pressure units are then converted to kPa, since this is the SI units of pressure (100 kPa atmospheric pressure). HOMAL vibration is measured in units of acceleration, e.g., meters per second (m/s)2) Rather than in hertz.

Latitude and longitude are recorded by HOMAL, as described below. These data are provided by the standard Global Positioning System (GPS), which is common in cellular telephones. After downloading from the ground-based server, this information is reported to the user via a real-time digital map.

Flights were conducted at the UAS test facility in southern maryland. For this experiment, all flights and arrangements were managed by a professional trained unmanned aerial vehicle system (UAS) pilot in concert with the experimental responsible. Two UAVs or "drones" are used; the primary drone carries the organ payload and the secondary drone ("chaser") serves as a safety measure. The secondary drone is also allowed video data collection of the primary drone, and rapid identification of the crash location in the event of a crash of the payload drone.

The master UAV is DJIM600 Pro. The apparatus contains 6 vertically oriented motors, which are operated by batteries. Each of the 6 motors is located directly below each rotor. This is advantageous because the payload does not directly contact the potentially heat generating motor. The DJIM600 uses a preheat time of approximately 5 minutes prior to active flight. During this time, the drone battery rises from ambient temperature to a target temperature of >25.0 degrees celsius. This particular drone can manage a payload of approximately 9.1kg (20 pounds). Drones are considered to fly at wind speeds up to 32.2km/h (20 mph). The GoPro camera is mounted at the bottom of the UAV for video data collection and visualizes the state of the organ in real time.

The slave drone is DJI instire 1. The drone has 4 vertically oriented rotors and an underneath mounted GoPro camera for video data collection. The drone is not designed to carry loads other than to act as a simple camera.

Prior to active flight, an official pre-flight preparation review (ORR) bulletin is made to determine the suitability of the local weather pattern. The united states Federal Aviation Administration (FAA) Automated Weather Observation Service (AWOS) located at saint mary airport (WX AWOS-3) in lundelton, maryland is utilized. People are determined and specific roles are assigned. Security measures are discussed. Has been approved by organ donors and their families.

During the experiment, data recording was performed by three sources: the HOMAL device itself; 2. manual recording during testing; and 3.DJIM600 drone. And the HOCAL data is stored in an onboard digital memory in real time. For this experiment, a Secure Digital (SD) card was used. The SD card works like a "black box" -as is standard in commercial flights. HOMAL data is also loaded to a ground-based server every 10 seconds and recorded to a Comma Separated Values (CSV) file. Each task is punctuated by a timestamp. The CSV file was then accessed and analyzed in Microsoft Excel Professional Plus 2016. Other statistical information was analyzed using International Business Machines (IBM) SPSS version 25. Due to the fact that task parameters are different between tasks, normalization processing is carried out on data, and therefore temperature, vibration and pressure can be compared between the tasks.

Prior to the experiment, the kidneys were transported into sterile cylindrical plastic containers containing the UW solution, according to standard practice. Also as is standard, two additional sterile organ bags are provided on the outside of the cylindrical plastic container. A mixture of non-sterile ice and water is provided on the exterior of the two sterile organ bags. Non-sterile ice and water are contained in a plastic lined styrofoam cooler to fit the size of the cardboard packaging box.

a) Measurement before flight.

The kidney temperature readings were taken in a room with an ambient temperature of 19.6 degrees celsius. The average temperature of the non-sterile fluid outside the kidney was 3.3 degrees celsius (SD 0.00). The UW solution was 0.9 degrees (average 4.2 degrees celsius, SD0.07) above the non-sterile ice water temperature (p < 0.001). The mean kidney core temperature was 5.8 degrees celsius. The lower pole of the kidney is warmer than the upper and middle poles (p < 0.05). There was no difference in temperature between the upper and middle pole portions (p > 0.05). During temperature measurement, the lower pole of the kidney is facing upwards, exposing it to a higher ambient temperature than the middle or upper pole.

b) Organ preparation and Loading

Next, the organ is prepared and loaded into the HOMAL device. Preparation of the organ lasted 5 minutes, which included removal of perirenal fat from the kidney. Placement of organs in HOMAL and arteries lasted <10 seconds for successful placement. Veins and ureters are not affected by HOMAL. The HOMAL temperature is then correlated to the UW solution into which the HOMAL is immersed. The average temperature recorded by HOMAL is 1.1 degrees Celsius higher than the UW solution. The kidney-HOMAL unit is then packaged in a smart cooler (container) for transport. Prior to active flight, a temperature drop to an average of 3.9 degrees celsius was observed. HOMAL showed a temperature stabilization at 2.5 degrees celsius within about 1 hour.

c) Ambient outdoor surveying

The environmental outdoor measurements reported by the FAA AWOS are as follows: the temperature of the time of flight is 5.0 degrees celsius, the visibility is 16.1km (10.0 miles), and the sky condition is "clear". The wind speed is 17km/h to 26km/h (9 sections to 14 sections). These data are considered to be advantageous.

d) Flight experiment

A total of 14 UAS tasks are performed. Vibration and air pressure vary with motion and altitude. The latitude and longitude vary as desired. After the motor was activated, only a slight increase in the vibration intensity was noted. The tasks reported in results sections 4a and 4b (below) took a total of 26 minutes of flight time.

Up and down. First, a series of takeoff-landing missions (n-5) are performed. With the organ as payload, the UAV was guided to take off and ascend at a speed of 1.5m/s to a maximum height of 61 meters (200 feet). At 61 meters, the drone is visible, but it is difficult to see the organ transport box from the ground with the naked eye. The temperature was stable (fig. 12A). The up and down motion is associated with a vibration change. The vibration variation does not exceed 0.5G (fig. 12B). When the kidneys reached maximum height, we observed a reduction in air pressure of 0.8 kPa.

Hovering. Next, the process of the present invention is described, A series of hover tasks (n-5) are performed. The drone is guided to take off and accelerate to a height of 30.5 meters (100 feet) at 1.5 m/s. At 30.5 meters, the organ payload is more clearly visible. During each of the 5 hovers, there is no fear of organ safety, and wind speed does not seem to affect drone and/or organ stability. During hovering, the temperature remains stable (fig. 12B). The vibration ranges are similar to those observed in up-and-down flight and are each less than 0.5G (fig. 12A). The pressure change was about half of the pressure change observed in the upper and lower tasks (0.4kPa), reflecting the relationship between the higher altitude and the lower air pressure.

Comparison with conventional flight. A series of long-distance tasks were performed (n-4). Each distance experiment included measurements taken at a height of 122 meters (400 feet)>762 meters (2500 feet) flight. These tasks are modeled based on the possible donation of donor organs between hospitals in the urban area. Tasks 1 and 2 taken 14 minutes and 22 seconds in total. The maximum speeds for tasks 1 and 2 are 38mph and 30mph, respectively.

The drone touches down in flight 2 and flight 3, during which the battery is replaced to allow additional distance testing to be performed. The speed difference is driven by the wind speed. Tasks 3 and 4 taken 12 minutes and 9 seconds in total. The highest speeds for task 3 and task 4 are 41mph and 42mph, respectively. The maximum travel distance was at the limit of the scene (experiment 3), during which the kidneys were transported out 2415 meters (7924 feet, 1.50 miles), for a total of 4830 meters (15,848 feet, 3.0 miles).

The King Air of the double-engine turboprop carries out standard fixed wing flight as the control of organ target aircraft transportation. Organs are usually refrigerated and transported by aircraft. The difference between fixed wing aircraft and UAVs is that fixed wing aircraft have a pressurized cabin. Thus, the primary comparison between standard flight and UAV flight is vibration. The flight lasted 28 minutes. Fixed-wing flight is associated with vibration changes greater than 2.0G. In the case of fixed-wing aircraft, significantly more vibrations are observed during takeoff and landing than with drone transport, and in the case of air travel there is a difference in vibration intensity or pressure (p <0.001) compared to drone travel. More specifically, organs experience more vibration events when fixed-wing aircraft take off and land than when unmanned transport is performed at any time during flight. In any event, the kidneys vibrate little when airborne.

Fig. 12A-12B are diagrams illustrating anatomical organ conditions stored and transmitted from temperature sensors and vibration sensors during UAV flight according to embodiments. The blue marks represent data recorded on a local storage (SD storage). The orange mark represents data transmitted by the wireless module. Fig. 12A shows vibration data recorded from the outside of the container. Fig. 12B shows temperature data measured from the surface of the organ. The vibration data in fig. 12A visibly indicate flight and rest periods, where the value of continuous stop at 1.0 × g indicates a static state or a smooth constant velocity flight, where gravity (1 × g) is the only acceleration measured. The period of intense vibration corresponds directly to the active UAV flight period, as compared to the position record.

Data stored directly on the organ sensor module shows high resolution recordings of both temperature and vibration. The sequential process slows down the transmission to the wireless communication device, thereby greatly reducing the time resolution. 12A and 12B compare data recorded directly at the organ module (-7.5 Hz), "stored data" and data transferred to the OTMS (-0.11 Hz), "transferred data" results show: the slower data rate does result in some data loss; however, the transmitted data provides a sufficient indication of vibration and temperature conditions to notify an observer on the remote mobile device of the abnormal situation during flight.

Figures 13A-13B are diagrams illustrating anatomical organ conditions stored and transmitted from altitude and vibration sensors during UAV flight experiencing rapid ascent and descent, according to one embodiment. Comparing the vibration record and the altitude record allows for correlating the land characteristics with the flight event. For example, the up/down cycle shows a periodic characteristic in the vibration data (see fig. 13A and 13B). A sharp change in the intensity of the vibration in the vertical direction may indicate a rapid rise or a free fall. The vibration measurements clearly demonstrate rapid rise and fall events compared to the height measurements taken from the vessel. Each directional change corresponds to a significant peak in the vibration map. The direction of the peak (up or down) directly indicates the direction of the height change. In short, when the organ experiences a constant velocity rise, there is little or no acceleration (i.e., vibration caused only by the drone), and then as the rise ends, the deceleration/cessation produces a measurable downward acceleration.

Although demonstration was ultimately successful, it was observed that the thermistor elements used in this experiment were incompatible with the ionic organ maintenance fluid used to maintain biological function during transport and were completely submerged. In other embodiments, the thermistor is configured to operate stably in an electrolyte solution (e.g., an electrical environment). For example, in some embodiments, the system includes a barrier formed of liquid neoprene and polyvinyl chloride heat shrink tubing. Furthermore, some other embodiments include the use of commercially available waterproof temperature sensors.

Fig. 14A-14C are diagrams illustrating anatomical organ conditions stored and transmitted from a vibration sensor (fig. 14A), a global positioning system receiver (fig. 14B), and an altitude sensor (fig. 14C) in multiple UAV flights, according to an embodiment. Four different flight segments are observed and are represented as time periods in fig. 14A to 14C. Period 1 to period 4 represent periods of high vibration that occur in various flight pattern tests; period 1: vertical take-off and rapid descent; period 2: vertical takeoff and fast ascent/descent periods; period 3& 4: vertical takeoff and long-distance (3km) transport tests.

Together, these data illustrate the feasibility of recording meaningful flight metrics and correlating measurement fluctuations to flight events. The relatively low sampling rate associated with the communication protocol provides some control over the depth of analysis that the current data set may be subjected to in this particular experiment. It will be appreciated that other embodiments may use higher data transfer rates or local storage.

In this experiment, a global positioning system receiver included in the sensor module enabled simple global positioning of the tracked packages. During the experiments, a small low-cost global positioning system receiver allowed robust positioning of the package over a distance of 3 km. It will be appreciated that off-the-shelf commercial software may be used to map data collected and reported by the global positioning system receiver, or transmitted using a wireless communication device, or data recorded internally in memory. This data, in combination with height data that may be collected from the air pressure sensor, may be used to illustrate the travel path throughout the test.

In addition, control experiments were conducted in which the HOMAL was further loaded onto a small, pilot-equipped, fixed-wing aircraft. During this experimental test, interference from a pilot's aircraft prevented the transmission of data from the HOMAL. In addition, the packaging is ready to damage the organ thermometer. As a result, only vibration data from the organ module is collected and processed.

FIG. 15 is a diagram illustrating anatomical organ conditions stored and transferred from vibration sensors during piloted fixed wing jet power flight according to one embodiment. Vibration data from the flight is used to identify specific events throughout the flight as period 1 to period 6: start (1), board boarding (2), taxi (3), takeoff (4), flight (5) and landing (6). The vibration patterns induced by each of these periods are not only different from other flight periods, but also different from the data collected during the UAV flight. Moderate vibration is observed in UAVs throughout longitudinal flight, with larger vibrations observed only at takeoff and landing in fixed wing aircraft, and relatively calm in other aspects of longitudinal flight.

e) Kidney status after unmanned aerial vehicle transport

After UAV flight testing, the kidneys were anatomically normal. The total time of the unmanned plane on board is 1 hour and 2 minutes. HOMAL is intact and there is no evidence of organ damage associated with HOMAL. Biopsies were taken immediately before and after drone flight. Unmanned aerial vehicle flight does not affect biopsy results. Before and after the unmanned plane flight, glomerulosclerosis, cortical scarring and hyaluronic acid account for 11% to 12%.

Despite the significant improvement in organ transplant outcome over the last decades, there is still a less than optimistic gap between the number of recipients on the organ transplant waiting list and the total number of transplantable organs. Indeed, this problem has stimulated interest in organ regeneration, 3D organ printing and xenotransplantation, but these techniques have been much less than clinically practical for many years.

Unmanned organ transport can expand donor organ banks and allow for more organ transplants. Lower CIT due to UAS trafficking may increase the longevity of the transplant recipient because organ quality is higher when CIT is lower and because higher quality organs lead to longer lifespan of the recipient. A patient receiving a high quality transplant is less likely to need a further transplant, thereby leaving another patient on the waiting list to receive the transplant. Also, if organs can be transported more efficiently, surgeons are more likely to receive organs, particularly those organs that are considered less important. Finally, if OPOs around the united states can mobilize organs faster, they may attract applications to many donors who are not currently considered candidates.

In the united states, the average rate of discarded kidneys is about 20%. Indeed, many of these kidneys may already be useful if CIT is accelerated. Based on the 20% value of 2016 and the transplant size of 13,501 dead donor kidneys, up to 2700 kidneys could be used for transplantation with minimized CIT. For example, one recent study showed that for a randomly selected 5,000 declining renal providers, patients are more likely to survive if the provider is accepted rather than rejected. These data indicate that more patients can be transplanted using currently available resources if tools such as the above-described organ monitoring devices and possibly unmanned aerial vehicles are able to shift the balance of information in favor of transplantation.

Drones that can take off and land directly at the transplant hospital can be converted into organ transporters, where reduced CIT is only one factor in drone speed and time spent packaging the organ. For example, if an organ drone can travel 350 miles per hour, the organ in los angeles can reach bartha in 7.5 hours (2645 miles). Likewise, new york organs can reach baltimore (192 miles) in 33 minutes. In contrast, the national average CIT is 16 to 18 hours, including local and national sharing. The inaccessible regions of a country, such as the average CIT in south florida, are significantly longer. In some regions, the CIT of the kidney is typically over 30 hours.

In the context of organ transplantation, the advantages of the methods and systems discussed herein may not only increase but also simplify data flow to stakeholders. For example, the state and location of the accepted organ can be accessed by simply opening an application (such as an OTMS) on the user's handset. As designed, the example embodiments discussed above reliably provide real-time organ status and location. These data are downloaded to a ground-based server and stored. These data may also be acquired in real-time on each project team member's handset. This is exciting, since time sensitive organ transplants are not currently monitored by GPS. Currently, obtaining updates of the status and location of organs requires multiple telephone communications with busy couriers.

3. Overview of hardware

FIG. 16 illustrates a chip set 1600 upon which an embodiment of the invention may be implemented. Chip set 1600 is programmed to perform one or more steps of the methods described herein and includes processor and memory components such as those described with respect to fig. 10 contained in one or more physical packages (e.g., chips). For example, a physical package includes an arrangement of one or more materials, components, and/or wires on a structural assembly (e.g., a substrate) to provide one or more characteristics, such as physical strength, size savings, and/or limitations of electrical interaction. It is contemplated that in some embodiments, the chipset may be implemented in a single chip. The chipset 1600, or portions thereof, constitute means for performing one or more steps of the methods described herein.

In one embodiment, the chipset 1600 includes a communication mechanism such as a bus 1601 to transfer information between the various components of the chipset 1600. A processor 1603 is connected to the bus 1601 to execute instructions and process information stored in, for example, a memory 1605. The processor 1603 may include one or more processing cores, where each core is configured to execute independently. The multi-core processor enables multiprocessing within a single physical enclosure. Examples of multi-core processors include two, four, eight, or more numbers of processing cores. Alternatively or additionally, the processor 1603 may include one or more microprocessors configured in series via the bus 1601 to enable independent execution of instructions, pipelining, and multithreading. The processor 1603 may also be accompanied by one or more special purpose components to perform certain processing functions and tasks, such as one or more Digital Signal Processors (DSPs) 1607, or one or more Application Specific Integrated Circuits (ASICs) 1609. The DSP 1607 is generally configured to process real-world signals (e.g., sounds) in real-time independent of the processor 1603. Similarly, ASIC 1609 may be configured to perform special-purpose functions not readily performed by general-purpose processors. As a non-limiting example, the ASIC 1609 can be a communications-specific circuit capable of sending and receiving information wirelessly (e.g., Wi-Fi, cellular, Bluetooth, GPS). In another non-limiting example, the ASIC 1609 can be a sensor capable of measuring environmental conditions or physical characteristics (e.g., barometric pressure, temperature, acceleration, inertia). Other specialized components to help perform the inventive functions described herein include one or more Field Programmable Gate Arrays (FPGAs) (not shown), one or more controllers (not shown), or one or more other special-purpose computer chips.

The processor 1603 and the accompanying components have connectivity to the memory 1605 via the bus 1601. The memory 1605 includes both dynamic memory (e.g., RAM, magnetic disk, writable optical disk, etc.) and static memory (e.g., ROM, CD-ROM, etc.) for storing executable instructions that, when executed, perform one or more steps of the methods described herein. The memory 1605 also stores data associated with or generated by the execution of one or more steps of the methods described herein.

Fig. 17 is a diagram of exemplary components of a mobile terminal 1700 (e.g., a cellular telephone handset) for communications, which is capable of performing the method of fig. 11, according to one embodiment. In some embodiments, mobile terminal 1701, or a portion thereof, constitutes a means for performing one or more of the steps described herein. In general, a radio receiver is defined in terms of front-end and back-end characteristics. The front-end of the receiver contains all the Radio Frequency (RF) circuitry, while the back-end contains all the baseband processing circuitry. As used in this application, the term "line" refers to: (1) this definition of "circuitry" applies to all uses of this term in this application, including in any claims as well, as another example, as used in this application and if applicable to a particular context, the term "circuitry" would also encompass implementations of only a processor (or multiple processors) and its (or their) accompanying software/or firmware Or similar integrated circuits in cellular network devices or other network devices.

The relevant internal components of the phone include a Main Control Unit (MCU)1703, a Digital Signal Processor (DSP)1705, and a receiver/transmitter unit including a microphone gain control unit and a speaker gain control unit. A main display unit 1707 provides a display to the user in support of various applications and mobile terminal functions that perform or support the steps described herein. The display 1707 includes display circuitry configured to display at least a portion of a user interface of the mobile terminal (e.g., mobile telephone). In addition, the display 1707 and display circuitry are configured to facilitate user control of at least some functions of the mobile terminal. The audio function circuit 1709 includes a microphone 1711 and a microphone amplifier that amplifies a voice signal output from the microphone 1711. The amplified speech signal output from the microphone 1711 is fed to a coder/decoder (CODEC) 1713.

The radio section 1715 amplifies power and converts frequency in order to communicate with a base station, which is included in the mobile communication system, via an antenna 1717. The Power Amplifier (PA)1719 and the transmitter/modulation circuitry are operationally responsive to the MCU 1703, with an output from the PA1719 coupled to the multiplexer 1721 or circulator or antenna switch, as is known in the art. The PA1719 is also coupled to a battery interface and power control unit 1720.

In use, a user of mobile terminal 1701 speaks into the microphone 1711 and his or her voice along with any detected background noise is converted into an analog voltage. The analog voltage is then converted to a digital signal by an analog-to-digital converter (ADC) 1723. The control unit 1703 sends the digital signal to the DSP 1705 for processing therein, such as speech encoding, channel encoding, encrypting, and interleaving. In one embodiment, the processed voice signals are encoded by units not separately shown using cellular transmission protocols such as enhanced data rates for global evolution (EDGE), General Packet Radio Service (GPRS), global system for mobile communications (GSM), internet protocol multimedia subsystem (IMS), Universal Mobile Telecommunications System (UMTS), etc., as well as any other suitable wireless medium, e.g., microwave access (WiMAX), Long Term Evolution (LTE) networks, Code Division Multiple Access (CDMA), Wideband Code Division Multiple Access (WCDMA), wireless fidelity (Wi-Fi), satellite, etc., or any combination thereof.

The encoded signal is then sent to an equalizer 1725 for compensation of any frequency-dependent impairments that occur during transmission though the air such as phase and amplitude distortion. After equalizing the bit stream, the modulator 1727 combines the signal with an RF signal generated in the RF interface 1729. The modulator 1727 generates a sine wave by way of frequency or phase modulation. To prepare the signal for transmission, an upconverter 1731 combines the sine wave output from the modulator 1727 with another sine wave generated by a synthesizer 1733 to achieve the desired frequency of transmission. The signal is then sent through a PA 1719 to increase the signal to the appropriate power level. In practical systems, the PA 1719 acts as a variable gain amplifier whose gain is controlled by the DSP 1705 based on information received from a network base station. The signal is then filtered within the duplexer 1721 and optionally sent to an antenna coupler 1735 to match impedances to provide maximum power transfer. Finally, the signal is transmitted via antenna 1717 to a local base station. An Automatic Gain Control (AGC) may be provided to control the gain of the final stages of the receiver. From there, the signal may be forwarded to a remote telephone, which may be another cellular telephone, any other mobile telephone, or a land-line connected to a Public Switched Telephone Network (PSTN) or other telephone network.

Voice signals transmitted to the mobile terminal 1701 are received via antenna 1717 and immediately amplified by a Low Noise Amplifier (LNA) 1737. A down-converter 1739 lowers the carrier frequency while the demodulator 1741 strips away the RF leaving only a digital bit stream. The signal then passes through an equalizer 1725 and is processed by the DSP 1705. A digital-to-analog converter (DAC)1743 converts the signals and the resulting output is transmitted to a user through a speaker 1745, all under control of a Main Control Unit (MCU)1703, which MCU1703 may be implemented as a Central Processing Unit (CPU) (not shown).

The MCU1703 receives various signals including input signals from the keyboard 1747. The keyboard 1747 and/or the MCU1703, as well as other user input components (e.g., the microphone 1711), include a user interface circuitry for managing user input. The MCU1703 runs a user interface software to facilitate user control of at least some functions of the mobile terminal 1701, as described herein. The MCU1703 also transmits a display command and a switch command to the display 1707 and the speech output switching controller, respectively. Further, the MCU1703 exchanges information with the DSP 1705 and can access an optionally incorporated SIM card 1749 and a memory 1751. In addition, the MCU1703 executes various control functions required of the terminal. Depending upon the implementation, the DSP 1705 may perform any of a variety of conventional digital processing functions on the voice signals. Additionally, DSP 1705 determines the background noise level of the local environment from the signals detected by microphone 1711 and sets the gain of microphone 1711 to a level selected to compensate for the natural tendency of the user of the mobile terminal 1701.

Decoder 1713 includes ADC 1723 and DAC 1743. The memory 1751 stores various data including call incoming audio data and is capable of storing other data including music data received via, for example, the global internet. The software module may reside in RAM memory, flash memory, registers, or any other form of writable storage medium known in the art. Memory device 1751 may be, but is not limited to, a single memory, CD, DVD, ROM, RAM, EEPROM, optical storage, magnetic disk storage, flash memory, or any other non-volatile storage medium capable of storing digital data.

An optionally incorporated SIM card 1749 carries, for example, important information, such as the cellular phone number, the carrier providing services, subscription details, and security information. The SIM card 1749 serves primarily to identify the mobile terminal 1701 on a radio network. The card 1749 also includes a memory for storing a personal telephone number registry, text messages, and user-specific mobile terminal settings.

In some embodiments, the mobile terminal 1701 includes a digital camera that includes an array of optical detectors, such as a charge-coupled device (CCD) array 1765. The output of this array is image data that is transmitted to the MCU for further processing, or stored in memory 1751, or both. In the illustrated embodiment, light is incident on the optical array member through a lens 1763, such as a pinhole lens or a material lens made of optical grade glass or plastic material. In the illustrated embodiment, the mobile terminal 1701 includes a light source 1761, such as an LED, to illuminate an object for capture by an optical array device, such as a CCD 1765. The light source is powered by the battery interface and power control module 1720 and is controlled by the MCU 1703 based on instructions stored or loaded into the MCU 1703.

In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. Throughout the specification and claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated item, element or step, or group of items, elements or steps, but not the exclusion of any other item, element or step, or group of items, elements or steps. In addition, the indefinite article "a" or "an" is intended to mean one or more of an item, element or step modified by the article. As used herein, unless otherwise clear from the context, a value "about" is another value if the value is within a factor of two (two or half) of the other value. Although example ranges are given, any included range is intended in various embodiments unless otherwise clear from the context. Thus, in some embodiments, a range from 0 to 10 includes a range from 1 to 4.

Reference to the literature

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