1. Field of the Invention
The present invention relates to a portable cryogenic carrying case for biological material.
2. Description of Related Art
The FDA recently approved the use of bone grafts, mesenchymal cells, umbilical stem cells, and skin grafts for clinical trials or use in the treatment of many conditions. Transplantation medicine is gaining in popularity as research snowballs and brings the potential advantages of this innovative approach forward. This is the time for development of new and better technologies that streamline the process from production of biomaterials (often consisting of cells to be used in grafting) to their use in treating patients.
Unfortunately, the technology involved in the production and distribution of the biomaterials has not kept pace with the biotechnical advances. Currently, it is normal practice for biomaterials, such as named above, to be transported on dry ice by a distribution company and then frozen at −80° C. or in liquid nitrogen by the purchasing facility, until they are used. The distribution company often supplies these freezers, at great expense to the medical facility. At each stage of transport, the shipment is checked manually, as nurses check boxes on a form, and sometimes even by computer. Full knowledge of what is happening to the biomaterials is woefully deficient. The transport container is only for transport and does nothing to facilitate the use of the biomaterial.
There are difficulties with every stage in the transport and use of biomaterials. For example, shipping biomaterials on dry ice (−78° C.) by FedEx is costly and requires one-time use containers. Although there is a record of where the biomaterials were and for how long, there is no way to know whether they were kept at the required temperature. Suboptimal temperatures are harmful to biologicals. Once the biomaterial arrives at its destination, medical personnel must transfer the biomaterial from the dry ice to a −80° C. freezer or liquid nitrogen tank without delay. More often than not, this vital step can be overlooked in a busy hospital. Moreover, since the freezer will contain other specimens, it is likely that an older shipment becomes confused with a newer one. Cells have a limited shelf life, which reduces the viability of a biomaterial graft and the chances that it will “take.” It is even possible that inadequate labeling may result in biomaterials from one patient being transferred into another, potentially causing a catastrophic immune reaction. Surgery or implantation of the biomaterial is often less than straightforward. The medical facility must have the requisite sterile instruments and working surfaces on hand. The biomaterial, which has been removed from the freezer to be ready for use, could become too warm due to delays, causing loss of cell viability and denaturation of growth factors. For this reason, some distributors have personnel wait in the room ready for the surgery to be performed until the biomaterial is developed. This is a very expensive and highly inconvenient.
Even under this labor intensive procedure, graft failure is common. Some of the leading causes of failure are hematoma formation, which can be avoided by meshing of the graft, infection, which can be reduced by meticulous preparation of the area, and surgeon error in placing the grafts upside down.
These are factors that the current systems of transport and delivery cannot address. The present invention, on the other hand, does. The reusable cryogenic carrying case of the present invention reduces many risk factors that cause biomaterial failure in skin grafts.
A mobile, compact, reusable carrier that is able to regulate its internal low temperature using an internal microcontrolled multicore pressure system, simplifies transportation and storage of biomaterials.
An inbuilt sterile instrument case with a work area, provides a surgeon with a useful tool that increases ease of care during a graft procedure. Grafts can fail due to hematoma, inadequate wound preparation and infection. The carrying case has a set of sterile surgical tools for fenestrating the grafts and reducing the likelihood of hematoma. The surgeon has everything needed in the case to thoroughly prepare a wound site.
The risks inherently associated with inadequate preparation of surgical trays due to operator error or even malfunctioning sterilization equipment is prevented. The inevitable infection risk associated with having an extra person scrub in (the person from the graft manufacturer) will be avoided. The carrying case has a pouch adjacent to the surgical tools where the graft is placed right side up, making correct placement obvious to the surgeon.
A microcontroller combined with sensors, a communication board, a radiofrequency identification (RFID) module, a display, and other peripherals in the carrying case enable it to interact with its environment. It collects real time data such as the temperature of the biomaterial, the contents of the case, its location, a log of how long the material has been in transit and where it has been. The data gathered is available to the user, the transport company, the biomaterial manufacturer, or any other interested party.
The exact nature of this invention, as well as the objects and advantages thereof, will become readily apparent from consideration of the following specification in conjunction with the accompanying drawings in which like reference numerals designate like parts throughout the figures thereof and wherein:
A preferred embodiment of the outside of the cryogenic carrying case, is shown in
The top and bottom of the case close at the front and are held together by permanent magnets 32 at all four corners 34. A wedge-shaped indentation 33 on the bottom part of the case allows easy opening of the case. One of the magnets in one of the corners of the case is paired with a magnetic switch sensor (not shown) that sends a signal to a microcontroller (described hereinafter), registering if the case is open or closed. The corners of the case 34 are semitransparent to allow light produced by LEDs 35 on the top of the case to propagate to the bottom. A strip 36 of high brightness LEDs is located on the top at the latch area 33, to illuminate the latch area.
The semitransparent corners 34 of the case have built in reflectors. The corners are interconnected by a fiberoptic strip 37. The bottom right corner of the case contains multiple diodes such as infrared receivers, IR transmitters, and triple color high power LEDs 38. These diodes are surface mounted on a printed circuit board (PCB). The light signals from these diodes are transmitted to the other corners via the fiberoptic strip 37 and reflected by the reflectors 39 in each corner. This light signal is transmitted between the top and bottom of the case by way of two pieces of fiberoptics enclosed in small transparent areas at each corner of the case that meet when the case is closed. A GPS and Wifi antenna is located in the bottom right reflector 40. A USB slot 41 is provided to allow added communication capabilities.
Referring now to
The top and bottom of the case is constructed from a multiple layer material, an example of which is shown in
A plate 63 in the top of the case contains all that a physician requires for accurate, effective, and sterile placement of the graft. An indentation in the top plate 64 contains a drum graft mesher 65, which is used to fenestrate the graft. The graft mesher 65 has a roller wheel 66 attached. This allows physical rotation of the drums. The mesher is held in place by spring-loaded clips at the end of shafts 67, for easy removal and cleaning. The fenestrated graft feeds into a collecting basin 68 that is usually filled with fluid to avoid drying and tearing of the fragile tissue.
Referring now to
Referring now to
The inner core 56, located in the case to be under the graft-containing pouch, is constructed of a thermoconductive material. The inner core is overlaid with a widely spread reinforcing Kevlar fiber net that has been soaked in thermoconductive materials such as, for example, resin or silicone gel (not shown). The inner core surface is in direct contact with the thermoconductive bottom part of the graft pouch, as shown in
The multi core cooling system is filled with liquid nitrogen through the inlet port 42 with the one-way valve 43 (
The filling process is illustrated in
The nitrogen gas then passes from the outer core into a pipe 76, through a double function thermo-insulated solenoid 77, into an overflow tank 74. The nitrogen gas builds up in the overflow tank 74 and an outlet serpentine pipe 78. The flow out the pipe 78 is limited by the adjustable pressure regulation exhaust valve 47 (
An important part of the function of the cryogenic carrying case is a microcontrolled solenoid 77. Because the resistance and the amount of power required to open the solenoid 77 is determined by the gas pressure on either side of the solenoid valve 77, this valve can also act as a pressure sensor, giving information back to the microcontroller. The microcontroller ensures that cooling system of the case, while the cooling system of the case is charging and nitrogen gas escapes into the overflow tank, the same amount is added to the inner core 56 until the inner core is full of liquid nitrogen. Because the solenoid operates electromagnetically, there is no direct connection between the moving components and the internal environment of the bottom of the case. Freezing or ice buildup, preventing effective function, is thus unlikely.
Once the cooling system is charged, the microcontroller stops energizing the solenoid 77, which causes it to close. The liquid state of the nitrogen in the inner core 56 is then maintained by pressure.
In order to cool down the case for use, and maintain a user-set temperature, a temperature sensor 79 (
For strength and insulation purposes, multilayer pipes (
Non-thermoconductive bushings 83 (
The majority of the electronic components of the cryogenic carrying case are located directly under the outer surface of the top of the case, as shown in
The PCB with microcontroller supports USB 41 so that various modules such as Blue Tooth®, Wifi® and GPS®, can be added. The Wifi, similarly, allows the case to transmit information and receive commands. The infrared (IR) transmitting and receiving diodes establish connections with IR capable devices and with other cases in the vicinity. Blue Tooth® establishes connection with Blue Tooth® enabled devices such as Android® phones, iPads® and some laptops. This compatibility with the Android® system is deliberate since the software is open source. However, the microprocessor in the case has internal memory so it can be preprogrammed and perform all the required functions without an external device.
The cryogenic carrying case gathers information about its contents and surroundings through a system of sensors. First, the radio frequency identification tag (RFID), located as part of the double coil 86 (
The cryogenic carrying case contains a triple color high power LED surface mounted diode 38 (
The cryogenic carrying case uses a charging coil that is connected to a lithium ion battery with charger 89 (
The microcontrolled double function solenoid 77 opens and closes based on readings from the temperature sensors in combination with software that allows the user to vary the range within which the microcontroller will activate the solenoid to open, allowing some high pressure coolant to escape. The solenoid 77 also acts as a pressure sensor because the amount of pressure in the inner core is proportional to the amount of power needed by the solenoid 77 to open it. The microcontroller can sense this change in terms of current and resistance and integrate this information with the information received from peripherals, such as the temperature sensors. This enables the microcontroller to estimate the amount of nitrogen remaining in the case and the number of hours the case has left.
Because of the risks inherent in using highly-pressurized gases, a system of safety measures has been integrated into the cryogenic carrying case. First, if the core system of the case is exposed to extreme heat, the liquid nitrogen will boil and, as a result, the solenoid valve 77 will sense increased pressure, as shown in
If the flow rate exceeds the maximum permitted by this valve, the gas will back up via the solenoid 77 and into the outer and inner core. When the pressure reaches the pre-set fail point of the cores, the case is compromised so that it is no longer useable. At ultrahigh pressures (
In summary, the invention is a portable reusable cryogenic carrying case for the transport, storage and use of temperature-sensitive materials. The case is capable of maintaining very low temperatures for extended periods of time while continuously monitoring and regulating the temperature of the biomaterial. It also gathers data such as a real time record of how old the biomaterial is, preventing use of cells with age-related diminished viability. Of course, it is entirely possible that the main benefit of biomaterial grafts consists in the secretion of growth factors, cytokines, and angiogenic factors. Again, the controlled environment provided by the case will guarantee that these biological agents remain active until the implant is placed and that the cells continue making them for as long as possible. The invention allows real time close monitoring of a biomaterial. It is possible to track immunologically distinct lines. These can be matched with the MHC profiles of individual patients, much as blood typing is today, thereby increasing the length of time that the cells will be viable, increasing the likelihood of success of graft procedures. From the moment the biomaterial is produced and placed in the device until the time it is sited on or in a patient, this invention will ensure that it is in a sealed, sterile container, kept at a constant temperature, monitored for temperature, location, and who performed the task, and the data are transmitted and made available to the distributor and end-user upon demand. The case benefits the patient, the medical facility, and the biomaterial producers. It is even environmentally friendly, being entirely re-usable.
In addition, the case can easily be modified for transport and storage of other temperature sensitive biologics, including blood, vaccines, viruses, sperm, and more. It can also be modified for nonbiologics. The case is also seen as having value for wound care in military zones, especially because it is easily transported and tracked.