Cannula for connecting to and interfacing with an organ

Abstract

A cannula (24000) for connecting a tissue vessel to be perfused to a perfusion loop. The cannula has a cannula body (24010) with a lumen (24030) extending therethrough. A first end of the cannula body is used for connection to the perfusion loop. The tissue vessel is held at a second end of the cannula body. Two clamping arms (24060, 24070) pivotally connected to the cannula body are provided for holding the vessel to be perfused in a compressed state.

Description

[Technical Field]

[0001] The present disclosure relates to tissue maintenance, assessment, maturation and repair for transplant recipients. More particularly, the present disclosure relates to an interface for non-destructively connecting to a tissue vasculature to enable connection of the tissue to a tissue life support system. [Background technology]

[0002] In 2020, approximately 39,000 tissue transplants of all types were performed in the United States. A new patient is added to the transplant waiting list every nine minutes. Many different types of tissues from organ donors are used. Tissues, including organs, considered for transplantation include, but are not limited to, kidney, pancreas, liver, heart, lung, stomach, intestine, composite allografts, thymus, uterus, skin, bone, tendon, middle ear, cartilage, heart valve, trachea, nerve, vein, hand, leg, arm, adrenal tissue, fetal thymus, cornea, and composite graft tissue. Regarding specific organs, as of 2020, 12,141 people were on the liver transplant waiting list in the United States, and only 8,906 transplants had been performed. There were 14,489 pancreas, heart, lung, and intestine candidates waiting for transplant. Furthermore, while there were 91,834 kidney candidates on the transplant list, only approximately 20,000 kidney transplants had been performed.

[0003] Regarding kidney disease, as of 2020, over 700,000 patients in the United States and an estimated 2 million patients worldwide suffered from end-stage renal disease (ESRD). Furthermore, the mortality rate among ESRD patients increased during the early months of the COVID-19 pandemic, resulting in an estimated 6,953 to 10,316 deaths. The primary treatments for ESRD are dialysis and kidney transplantation. In the United States, the overwhelming majority of people with ESRD undergo dialysis, with only a small percentage surviving transplant surgery. Dialysis patients generally have a shorter life expectancy and lower quality of life than kidney transplant recipients. Most transplanted kidneys come from deceased donors, and yet many of these available kidneys are discarded. Deceased donor kidneys present several challenges, including a relatively high rate of delayed graft function (DGF), a relatively long warm ischemic time during renal recovery, a relatively high degree of cold injury, and a relatively low long-term graft survival rate.

[0004] In harvesting tissue for transplantation, the support tissue, which supplies the tissue with necessary life support and provides necessary connective tissue during transplantation, is cut in a manner that leaves as much of the support tissue intact as possible. During storage and transplantation, support means are often attached, detached, and reattached to the support tissue to facilitate the delivery of life-sustaining nutrients to the tissue to be transplanted. During such attachment, detachment, and reattachment, incremental portions of the support tissue are often cut or altered, thereby reducing the support tissue available for subsequent attachment during transplantation.

[0005] Improved options for preserving tissue awaiting transplantation include normothermic / subnormothermic perfusion, which has a high probability of extending preservation time, allowing real-time tissue diagnosis, and significantly reducing cold injury. Preservation techniques such as ex vivo normothermic machine perfusion (NMP) can be used to assess pre-transplant tissue quality before sending the recipient for surgery. Normothermic or subnormothermic perfusion results in metabolically active tissue, which can allow assessment through direct measurement of renal function and by allowing laboratory analysis of tissue and perfusate samples. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, a need exists for a system designed to reduce the amount of tissue discarded. Furthermore, a further need exists for a system that facilitates interfacing with transplant tissue in a manner that maintains a preselected oxygen level in the circulating perfusate and / or that can constantly monitor the tissue and dynamically adjust the desired oxygen level, possibly during transport from donor to transplant recipient. Furthermore, a system is needed that can provide a releasable, intact tissue interface that provides the tissue with the nutrients necessary to maintain tissue vitality prior to transplantation while preserving supporting tissue intact to improve the success rate of future transplants, while still allowing the interface to detect a sufficient range of properties, such as, but not limited to, glucose and pH, to assist medical professionals in determining the viability of the tissue. A successful tissue maintenance and assessment system would provide medical professionals with a quantitative measure of tissue health, allowing them to recondition the tissue to optimize its performance prior to transplantation and enabling ex vivo treatment of the tissue, such as, but not limited to, pharmacological and gene therapy. What is also needed is a system that achieves low hemolysis and maintains desired tissue properties. What is needed is a normothermic / subnormothermic tissue perfusion device with on-board sensors to simulate the body's blood circulation and monitor the tissue, respectively. What is needed is a device that allows for releasable interfaces, output flow, sampling, and recirculation. [Means for solving the problem]

[0007] According to some configurations, the present teachings include interface systems and methods for tissue perfusion aimed at maintaining and possibly repairing tissue. Among other features, the present teachings provide an interface for interconnecting a support system, which may include a tissue enclosure with a fluid reservoir, with a transplant tissue. Pumps, valves, and a controller can move perfusion fluid through the tissue via the interface. The support system can include features to assist in monitoring tissue health and a removable tray to facilitate movement of the tissue from its origin to the tissue enclosure. The system of the present teachings is fully configured to perfuse and provide nutrients for transplant tissue, such as human tissue. Other features of the system of the present teachings include, but are not limited to, a urine flow rate sensor, a nutrient pump, disposable and durable components, and a non-contact (with the perfusion fluid) sensor.

[0008] A system for perfusing an organ of the present teachings can include at least one controller or processor that can enable valves and pumps to perfuse fluid through tissue, such as, but not limited to, human tissue. The at least one controller / processor can be, for example, but not limited to, a general-purpose processor that manages multiple tasks, a custom processor configured to manage a specific task, proportional and integral controllers, differential controllers, programmable logic controllers, distributed control systems, programmable automation controllers, microcontrollers, microprocessors, embedded processors, or supervisory control and data acquisition software. The controller / processor can receive data from sensors and other forms of data inputs located throughout the system and adjust pumps and valves, among other things, according to the data. For example, the controller / processor can receive user input, recipe input, and / or default settings that can be used along with sensor data values ​​to adjust perfusion fluid flow parameters. In addition to controlling the flow of perfusion fluid, the controller / processor can issue commands to pumps and valves to regulate the delivery of infusion fluid / nutrients to the tissue. In some configurations, infusion fluid / nutrients can be pumped into fluid in a fluid reservoir that is in fluid communication with the tissue. The contents of possible infusion fluid / nutrient options can be pumped into the fluid reservoir when the sensors indicate the need to modify the irrigation fluid. The system of the present teachings can include a pumping cassette that, under direction from a controller / processor, can deliver nutrients / infusion fluids at rates that can be variable and specific to a particular tissue and the tissue's current condition. The controller can perform processing associated with a particular set of sensors. In some configurations, the controller can automatically determine which sensors are available in a particular system and execute processes associated with the identified sensors.

[0009] Systems of the present teachings can include a pump subsystem capable of enabling tissue perfusion and perfusate recirculation. The pump subsystem can pump perfusate, such as blood and other additives, through the tissue. The blood can include, for example, whole blood or packed red blood cells. In some configurations, the pump subsystem can enable perfusate flow at rates up to 600 ml / min at pressures of 20-120 mmHg. The flow can optionally be pulsatile, and the flow rate can be adjustable. As an example, lower flow rates may be required for cold or damaged tissue. As tissue function improves, the flow rate can be adjusted to accommodate changed conditions. Both pulsatile flow and flow rates controlled by physiological parameters are possible with pumps of the present teachings. One goal in pump selection is to reduce hemolysis. For humidified materials such as those discussed herein, a direct-acting air pump can enable minimal hemolysis and flow measurements. It may be possible to modify the pumping cycle of a direct-acting air pump to match the physiological pulsatile pressure duty cycle.

[0010] The role of the perfusion loop is to provide basic biological functions that would otherwise occur in the body. These include oxygenation, nutrient supply, heat control, and carbon dioxide removal. Oxygenation and carbon dioxide removal are achieved through the use of a membrane oxygenator. A heat exchanger is used to maintain the desired perfusate temperature. The perfusion fluid leaves the tissue, passes through the oxygenator, passes through the heat exchanger, and is then pumped back into the tissue. Nutrients are provided in the perfusion solution and can be added manually or through the use of an automated infusion pump. Tissue-generated products flow out of the tissue and are available for sampling through a sterile sample port. The products can be directed back into the perfusion loop or discarded. The product flow rate and volume are measured and stored by the system. If product recirculation proves to be a challenge, the system can be modified to collect the product or potentially pass it through the dialysis loop.

[0011] The perfusion loop essentially agitates the tissue reservoir, allowing for the filling or draining of the fluid reservoir and the recirculation of fluid from the tissue reservoir, acting as a maintenance loop for the system. This loop can include an infusion pump so that infusion fluid can be delivered to the perfusion fluid, where it can be diluted and mixed, instead of passing directly into the tissue. Some or all of the infusion pumps can be part of the perfusion loop. In some configurations, the system includes a bypass valve that can be opened during priming if an air bubble is detected. To introduce new blood or drain the system, the system includes at least one valve associated with the infusion fluid passageway. In some configurations, one pinch valve can be associated with the inflow perfusion fluid, while another pinch valve can be associated with the drain passageway. In one embodiment, an air valve can be used. Other types of valves are contemplated by the present teachings. The perfusion fluid pump can also drain the tissue enclosure.

[0012] The system includes means for monitoring, for example, the tissue, the perfusate, and the tissue's output. Data collected during monitoring can be used, for example, to adjust the tissue environment and perfusate characteristics. Any type and number of sensors can be used for monitoring, and the controller can be programmed to automatically or manually respond to momentary conditions. In some configurations, sensors strategically positioned within the perfusion loop monitor the type of nutrients provided, dissolved oxygen in the perfusate, blood oxygen saturation level, perfusion pump rate, glucose, temperature, pH, and / or CO2. The system includes sensors to enable proper perfusion and collect data for tissue assessment, sterile sample ports for removing product and perfusate fluids using sterile syringes, and sensors external to the fluid pathway as well as sensors within the fluid pathway.

[0013] The tissue enclosure provides a barrier to contamination of the tissue as it is maintained. In one embodiment, the tissue enclosure includes three main parts: a fluid reservoir, a tissue platform, and a hood, all operatively coupled to form an isolated environment for the tissue. The tissue enclosure geometry includes a connector for receiving the tissue platform, a connector and seal for receiving blood, a well for receiving fluid, a void above the fluid in which the tissue platform is placed, and a fluid ramp for receiving at least a portion of the tissue product and directing the product toward the fluid reservoir. A temperature control mechanism is positioned near the tissue enclosure. In an exemplary configuration, the temperature control mechanism is positioned directly below the tissue enclosure and is fluidly coupled to the tissue enclosure.

[0014] In one aspect, the fluid reservoir contains, for example, but not limited to, tissue output, venous output from the tissue, and possibly nutrients and medications. The types and amounts of components in the fluid are not limited to additives as listed herein, but instead include components appropriate for the type of tissue being maintained. The fluid reservoir is located below the tissue platform, such that the tissue resides in the space above the fluid reservoir. Perfusion fluid is pumped from the fluid reservoir, and its properties and temperature are regulated and monitored before being pumped into the tissue.

[0015] The tissue platform can optionally be divided into multiple areas on the platform floor. One area can be configured to accommodate tissue. The tissue itself can be positioned on the platform floor, where it can be intubated or otherwise operatively coupled to perfusion tubing. In some configurations, the tissue is secured to the platform by, for example, straps, tie-downs, belts, or cords secured within recesses on the rim of the tissue platform. A portion of the floor can be configured to manage tubing and possibly cabling. Tube management techniques can include, but are not limited to, weld-mount clamps, rail clamps, magnetic clamps, snap-in clamps, multi-line clamps, connectable clamps, telescoping clamps, adhesive-backed clamps, lock-close strut-mount clamps, standoff clamps, low-profile clamps, and loop clamps. In an exemplary configuration, tubes and cables are routed through merlons positioned on the tissue platform floor, spaced apart depending on the expected size of the tubes and cables. Other tube and cable attachment points allow the tubes and cables to be elevated above the platform floor. In an exemplary configuration, one or more standoff features are configured with tube holders, such as curved, finger-like protrusions. In an exemplary configuration, tubing and cables are routed along the sides of the tissue platform between crenellated edges to allow for tube / cable routing between the tissue platform and other components of the tissue maintenance system. The crenellations can be spaced apart depending on desired or expected tube / cable sizes. If desired, the space between the crenellations can accommodate multiple tubes / cables. Tubing or cabling is routed to exit the tissue platform by, for example, but not limited to, piping, routing tubing, routing panels, or channeling. The tubing is coupled with a connector that allows for connection to additional tubing within the tissue enclosure.On-board coupling between the tissue and the perfusion tubing or other required system connections allows the tissue to be prepared for management by the system remote from the tissue enclosure and convenient to the tissue's location, thus reducing the amount of manual manipulation the tissue must endure.

[0016] Other platform configurations are contemplated by the present teachings. A platform detachable from a fluid reservoir may be the only component of the system that may be tissue type specific, although it is contemplated for use with multiple tissue types. The platform described herein for use with the kidney exemplifies specific platform features. The present disclosure is not limited to housing a kidney platform, nor is it limited to the geometry of the kidney platform.

[0017] In one embodiment, the tissue enclosure includes a hood that includes a durable / disposable barrier and houses at least one sensor. The gasket and barrier fitted to the tissue enclosure protect the tissue on the tissue platform from external environmental conditions. The barrier allows for manual and automated observation of the tissue on the tissue platform and is securely attached to the rim of the tissue enclosure to protect the tissue while still providing viewing options. Observation can include providing images of the tissue, which can assist the user in assessing the tissue. For example, the tissue can be measured, the color of the tissue can be observed to detect, for example, free hemoglobin or bacterial infection, and the size / shape of the tissue over time can be determined to detect, for example, whether the tissue is edematous. If the tissue is performing a specific physiological function, the user and / or controller can observe the function of the tissue over time.

[0018] The system of the present teachings pumps perfusion fluid through tissue in a closed loop. In one embodiment, the system includes one or more fluid pumps to achieve perfusion. Types of perfusion pumps include, but are not limited to, axial pumps, peristaltic pumps, diaphragm pumps, pumping cassettes, roller pumps, centrifugal pumps, pulsatile pumps, and non-occlusive roller pumps. Pumps that enable perfusion in the system of the present teachings can deliver physiological blood flow against high resistance without damaging the blood, provide accurate and easily monitored flow rates, create no turbulence or stagnation, and are manually operable even in the event of a power failure. In some configurations, an extracorporeal membrane oxygenation (ECMO)-type device is used to perfuse and oxygenate blood within the system. In some configurations, the oxygenator device uses a silicone membrane contactor. The perfusion fluid is pumped through multiple possible correction stations and past multiple sensors before entering the tissue. In an exemplary configuration, a pumping cassette can move perfusion fluid from a fluid reservoir into the oxygenator under the direction of a controller.

[0019] The tissue receives perfusion fluid into a cannulated tissue orifice and outputs a product through another cannulated tissue orifice. For example, if the tissue is a kidney, at least one of the products is urine. At least one product from the tissue is routed from the tissue for product monitoring before being routed back into a fluid reservoir or to a waste area. To enable product monitoring, the system includes a product flow device including a collector container and a sensor, and a means for managing the accumulation of the collection device. The container can have any shape and can include, for example, graduated fill marks. Convenience of assembling the container relative to the platform and product metrics can be considered when selecting the shape and size of the container. The container includes at least one sensor that indicates the level of product in the container to the controller. In some configurations, the container is coupled to multiple sensors, at least one of which indicates a desired high product level and at least one of which indicates a desired low product level. When the product reaches the high level sensor, the controller directs the valve to open and release the product. When the product reaches the low level sensor, the controller directs the valve to close, again retaining the fluid within the container. In an exemplary configuration, the level sensor includes an ultrasonic sensor. In one embodiment, the level sensor includes at least one visual sensor that determines the fluid level by locating a float within the fluid. The present teachings contemplate multiple high and low levels to enable various types of measurements. Valves include, but are not limited to, selected from and including ball valves, butterfly valves, check valves, gate valves, knife gate valves, spherical valves, needle valves, pinch valves, and plug valves. In an exemplary configuration, the valve is a pinch valve. In one embodiment, the valve is a pneumatic valve. In some configurations, the product flow device is configured to allow visualization of the product. For example, the product passes through a transparent or partially transparent container. The container can be completely opaque except for the window, or it can be substantially transparent, or some layout in between.

[0020] The system of the present teachings provides nutrients and medications, for example, to tissues as needed. A controller controls devices that access various infusion fluid materials depending on the needs of the tissue. Nutrients and medications can include, but are not limited to, water, lipids, amino acids, glucose, vitamins, hormones, antibiotics, chemotherapeutic drugs, vasodilators, vasoconstrictors, diuretics, antidiuretics, antihemorrhagic agents, and insulin. In one embodiment, kidney characteristics are controlled by adjusting the substances infused, monitoring the results of the infusion on kidney characteristics, and then adjusting the infusion rate based on the results. Nutrients are provided by an infusion pump, a device that delivers nutrients and medications in controlled amounts. The pump is configured either automatically or manually to provide specific nutrients at specific flow rates. Automatic infusion configuration occurs when the system of the present teachings determines what type of tissue is being treated and automatically configures the nutrient and medication regimen. Manual infusion configuration occurs when the system accesses or the user provides setup parameters, such as nutrient and / or medication components and delivery rate and delivery time. In either case, the controller determines an alert when there is a potential or actual pump failure or a potential or actual drug interaction problem, among other types of alerts. In an exemplary configuration, nutrients and medications are pumped into a fluid reservoir by a fluid pump, the possibilities of which are described herein. In an exemplary configuration, a pumping cassette pumps nutrients and medications to the tissue, either directly into the arterial line or into a reservoir. In one embodiment, the pumping cassette is sized to accommodate the nutrient / medication delivery requirements. For example, the pumping cassette includes a single chamber that pumps a preselected amount of fluid at a consistent rate, such as 10 ml / hour. In one embodiment, sensors measure the consumption rate of nutrients / medications, and these sensor data are used to control the infusion of these components. For example, a glucose sensor measures how much glucose is in the perfusate exiting the tissue, and the measurement is used to adjust the amount of glucose infused based on the metabolic rate of the tissue.The nutrient pump of the present teachings is configured to pump from an intravenous bag at a rate of 1-20 mL / hour, eliminating the need for an intravenous pump. In one embodiment, the nutrient pump is a sterile, disposable device that can be integrated with the pneumatic system of the present teachings. In one embodiment, the nutrient pump provides closed-loop glucose control.

[0021] In some configurations, low-bolus, high-precision infusion pumps are used to allow for clinical infusion of prescription vasodilators or insulin. In some configurations, multiple infusion pumps are used to allow for the infusion of multiple different substances, possibly simultaneously. In some configurations, the pump reservoir is 3 mL, and the pump accommodates infusion rates of 0.5 to 300.0 μL / hour and infusion volumes of 0.5 to 250.0 μL, infused into a recirculation loop that replenishes the tissue enclosure.

[0022] Methods of the present teachings can include, without limitation, assembling tissue onto a tissue platform and preparing it for connection to a fluid reservoir. The method can include coupling preselected locations on the platform with orifices in the tissue through tubing, connectors, etc. For example, if the platform is configured for a kidney, it can include a connector and tubing for transporting perfusate into the kidney and another connector and tubing for transporting urine from the kidney. The method can include directing venous output into a fluid reservoir. The vein can be cannulated and directed by tubing to the fluid reservoir, or it can simply exit the kidney and pass through a cavity in the platform to the tissue reservoir. In an exemplary configuration, the artery and ureter can be cannulated, and the cannulation tubing can be passed through protrusions on the platform that can prevent movement of the tubing en route to the orifices and connectors in the platform.

[0023] In one embodiment, the means for coupling to the tissue orifice includes a cannula configured and arranged to interface with the tissue at one end and with the tubing of the perfusion loop at the opposite end. The cannula includes at least one cannula strut with a lumen extending therethrough such that the cannula strut is inserted into the tissue vasculature. For example, when configured for use in the kidney, the cannula strut can be inserted into the renal artery, vein, or urethra and connected to the tubing of the perfusion loop at the opposite end. The cannula may include an overmolded region to provide flexibility in the contact area of ​​the cannula while providing a secure seal between the tissue vasculature and the cannula. The cannula may also include a retractable locking collar for clamping, retaining, and sealing the tissue vasculature onto the cannula strut.

[0024] In another embodiment, the means for coupling to the tissue orifice includes a cannula configured and arranged to interface with tissue at one end and with tubing of a perfusion loop at the opposite end. The cannula includes at least one annular pad with a lumen extending therethrough such that the distal ends of the tissue vessels are received adjacent the annular pad. For example, when configured for use in the kidney, the distal ends of the renal arteries, veins, or urethra are received in contact with the annular pad and connected to tubing of the perfusion loop at the opposite end. The cannula may include an overmolded area to provide a flexible contact area of ​​the cannula while simultaneously providing a secure seal between the tissue vessels and the cannula. The cannula may also include a retractable locking collar for clamping, retaining, and sealing the tissue vessels onto the annular pad.

[0025] In some embodiments, the means for engaging tissue includes a displacement means for moving the locking collar in a manner to clamp the tissue orifice in contact with the annular pad and / or cannula post.

[0026] In some embodiments, the annular pad and / or cannula posts and locking collar may be configured to accommodate two or more vessels of tissue.

[0027] In another embodiment, the means for coupling to the tissue orifice includes a cannula constructed and arranged to interface with the tissue at one end and with the tubing of the perfusion loop at the opposite end. The cannula includes at least one annular pad with a lumen extending therethrough. One or more optional cannula posts, each having a flared end, may be positioned in contact with the annular pad such that the lumen therethrough aligns with an opening in the annular pad. One or more vessels of the tissue are housed on the one or more cannula posts. The cannula may also include a retractable locking collar for clamping, retaining, and sealing the tissue vessels and any cannula posts onto the annular pad.

[0028] The method can include coupling a platform connector to a perfusion system and fitting the platform in place over fluid in a fluid reservoir. The fluid reservoir can include a space below the platform for fluid into which products from tissue mounted on the platform can flow. For example, if the tissue is a kidney, the products can be venous perfusion fluid and urine.

[0029] The systems of the present teachings include a combination of disposable and durable materials. For example, the oxygenation means, along with the heat exchanger, is disposable, while the thermal energy source is durable. At least one perfusion pump is disposable, while at least one pump interface connecting the at least one disposable pump to the pneumatic system is durable. At least one infusion pump is disposable. The pneumatic system can optionally include at least one durable valve, at least one durable chamber, at least one durable pressure source, and at least one durable vacuum source. The durable components can include at least one sensor that provides sensor data for monitoring the tissue, and at least one controller that receives and processes the sensor data. Disposable components can include spot sensors, tubing, cannulas, cassette pumps, tissue containers, and oxygenators.

[0030] The foregoing features of the present disclosure will be more readily understood by reference to the foregoing description taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0031] [Figure 1A] FIG. 1A is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figure 1B] FIG. 1B is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figure 1C] FIG. 1C is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figure 1D] FIG. 1D is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figure 1E] FIG. 1E is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figure 1F] FIG. 1F is a schematic block diagram of a system of the present teachings for maintaining and assessing tissue. [Figures 2A-2V]2A-2V are schematic perspective, elevational, and top / bottom / side views of one configuration of one cannula of the present teachings. [Figures 3A-3E] 3A-3E are schematic perspective, elevation, and top / bottom / side views of one configuration of an alternative cannula of the present teachings. [Figures 4A-4E] 4A-4E are schematic perspective, elevation, and top / bottom / side views of one configuration of another alternative cannula of the present teachings. [Figures 5A-5D] 5A-5D are schematic perspective, elevational, and top / bottom / side views of one configuration of yet another alternative cannula of the present teachings. [Figures 6A-6B] 6A-6B are schematic perspective, elevation, and top / bottom / side views of one configuration of another alternative cannula of the present teachings. [Figure 7A-7C] 7A-7C are schematic perspective, elevational, and top / bottom / side views of one configuration of a further alternative cannula of the present teachings. DETAILED DESCRIPTION OF THE INVENTION

[0032] Systems of the present teachings for maintaining, assessing, maturing, and repairing tissue are described in detail herein. In this regard, the present disclosure relates to maintaining, assessing, maturing, and repairing tissue for transplant recipients. More specifically, the present disclosure relates to interfaces for non-destructively connecting tissue vasculature to enable connection of the tissue to a tissue life support system. The systems and methods of the present teachings are configured to provide a releasable, non-destructive interface for interfacing with tissue to enable real-time assessment of the tissue, using said assessment to continuously maintain the health of the tissue. The systems of the present teachings include, but are not limited to, a disposable component set and a durable component set. The disposable components include, but are not limited to, a tissue container assembly and perfusate reservoir for holding the tissue, a perfusion pump assembly for pumping perfusate through the tissue, tubing and tissue interfaces for connecting the tissue container assembly to the perfusion pump assembly, a tissue gas regulating device for maintaining the myriad properties of the perfusate, and sensors for providing data about the tissue necessary for maintaining the tissue. Disposable components may also include at least one infusion pump assembly that provides nutrients and medications to the tissue, and a sampling assembly that receives output from the tissue, assesses the output in real time and possibly offline, and returns the output to the tissue container perfusate reservoir. Durable components include, but are not limited to, a tank monitor assembly that protects the tissue from environmental contamination and allows visual and sensory recording of the tissue, a thermal regulation assembly that maintains the temperature of the perfusate, a pneumatic system assembly that drives the perfusion pump assembly to circulate the perfusate, and power, data, and control electronics that power the system components and sequence events within the system based at least on sensor data.

[0033] 1A-1F, various configurations of systems for maintaining, assessing, maturing, and repairing tissue are illustrated in block diagram form. All exemplary configurations include durable and disposable assemblies. The present teachings contemplate additional configurations beyond those depicted herein. The drawings in FIGS. 1A-1E are for illustrative purposes only. In one embodiment, system 100 (FIG. 1A) of the present teachings includes durable assembly 115A (FIG. 1A) and disposable assembly 113 (FIGS. 1A-1D). Disposable assembly 113 (FIGS. 1A-1D) includes a container or reservoir that houses the tissue to be maintained and assessed. The container is operatively coupled to durable assembly 115A (FIG. 1A) while protecting the enclosed tissue and fluids that nourish and medicate the tissue from environmental contamination. Durable assembly 115A (FIG. 1A) includes tank monitor 119 (FIGS. 1A-1D), electronics 111 (FIGS. 1A-1D), thermal regulation assembly 107 (FIGS. 1A-1D), and pneumatic system assembly 105 (FIGS. 1A-1D). Tank monitor 119 (FIGS. 1A-1D) includes at least one sensor capable of capturing and retaining data about tissue placed within disposable assembly 113. Tank monitor 119 (FIGS. 1A-1D) includes a transparent barrier that can readily allow tissue examination while simultaneously protecting the tissue from environmental contamination, for example. The barrier can be completely transparent to all frequencies or completely transparent to some frequencies and opaque to other frequencies. It is also possible for one portion of the barrier to be opaque and another portion to be transparent. Examination can be manual, manually activated by a sensor, partially automatic, or fully automatic through a controller-activated sensor. The sensors can include, but are not limited to, cameras and x-rays, and remote probes that monitor, for example, temperature, humidity, light, pressure, air quality, and differential air pressure. Electronics 111 (FIGS. 1A-1D) includes a controller that manages various activities related to the sensors, such as, for example, collecting, displaying, analyzing, and storing data from the sensors.Thermal regulation assembly 107 (FIGS. 1A-1D) maintains a desired temperature within disposable assembly 113 (FIGS. 1A-1D) and provides thermal regulation for the perfusion fluid used to nourish and medicate tissue without contacting the tissue. A pneumatic system assembly 105 (FIGS. 1A-1D) drives at least one disposable pump, enabling movement of perfusion fluid, nutrients, and medications to and through the tissue. Other methods for driving pumps are contemplated by the present teachings. Pumps in the systems of the present teachings have delivery requirements. These requirements dictate the desired characteristics of any device that drives the pump. In one aspect, a pneumatic valve assembly can deliver the required volume without damaging the traversing fluid.

[0034] 1B, an exemplary system 200 includes a durability assembly 115B that includes a tank thermal regulation assembly 109. In such a configuration, the tank thermal regulation assembly 109 insulates the tank and provides thermal control for the tank. The purpose of the assembly is to substantially prevent condensation from adhering to the tank. Condensation on the tank can affect tissue monitoring and may represent a condensation / evaporation cycle that can affect tissue viability by dehydrating the tissue or completely drying out the tissue surface. Insulating the tank can reduce condensation, and thermal control can also reduce condensation.

[0035] 1C , an exemplary system 150 includes a user interface 101 and a product monitor 103. In such a configuration, sensor data collected by sensors in the durable assembly 115C and the disposable assembly 113 can be made available to a user through the user interface 101. Possible user interface options include wired and wireless devices, devices with and without visual, audio, and tactile interfaces, and / or combinations of interfaces. For example, a computer monitor can display a readout of the sensor data collected about the tissue and can be coupled to a keyboard where a user can request data types and / or control the sequencing of events occurring about the tissue. The user interface can be used to fully or partially override or extend any automatic behaviors the system takes to maintain the tissue. Changes in the tissue over time can be depicted graphically, either through a table of tissue characteristics over time, a graphical depiction of such data, photographs and / or videos of the tissue at various checkpoints or continuously, audio reports of the tissue, and / or a tactile readout of the status. Data can be analyzed and recorded, and the user and / or system can retrieve the analyzed data. The product monitor 103 allows for the collection, measurement, testing, and routing of product from the tissue based on automatic and / or manual selection. The product monitor 103 includes a vial into which the tissue product is routed, such as by tubing cannulated into an orifice in the tissue, e.g., a ureter if the tissue is a kidney. Other types of product routing are also contemplated by the present teachings. In either case, the tissue enclosure is properly sealed from environmental contaminants even as the product travels from inside the enclosure to a collection point outside the enclosure. Connectors providing environmental isolation and a closed circulation path maintain the desired protection against contaminants. The product travels to a collection point where it can be measured, assessed, and released.The collection point can allow assessment, including manual visual inspection, fully automated multi-sensor assessment, and any type of testing and assessment in between. For example, if the tissue is a kidney, a user can visually inspect the urine if the collection point is configured as a transparent or translucent container and manually adjust parameters that can restore the urine to a healthy appearance. Similarly, sensors can automatically transmit data about the urine to a controller, which can automatically adjust parameters that affect kidney health. In one embodiment, the collection point includes at least one inflow fluid passageway that receives output from the tissue into the collection point. In one embodiment, the collection point includes a means for detecting the volume of the output. Once a preselected amount of output has been collected, the amount is measured and released through at least one outflow fluid passageway. In one embodiment, the means for detecting the volume includes at least one sensor coupled to at least one valve controlled by the controller. In one embodiment, the controller receives a signal when a level sensor detects that fluid has reached a preselected level in the collection device. In one embodiment, the controller activates the sensor to examine the collected output. Upon completion of the investigation, the controller opens at least one valve to release the product. The controller discontinues the release by closing the valve when the level sensor detects that the fluid has reached a preselected level in the collection device. Other means for measuring the product level are also contemplated by the present teachings. The product can be released into at least one reservoir. In one embodiment, the product can be released into a reservoir selected by the controller. In one embodiment, a single effluent product pathway can be routed through a multi-path connector. In one embodiment, one pathway can route fluid to a tissue container and merge with the perfusate reservoir. In one embodiment, one pathway can route fluid into a waste reservoir that can be removed and placed in a suitable receptacle. In one embodiment, one pathway can route fluid into a sample reservoir that can be removed and assessed offline.Other product passageways are also contemplated by the present teachings.

[0036] 1D , the durable assembly 115C of the exemplary system 250 can include a disposable release device 108. In one embodiment, the disposable assembly 113 can be fully decoupled from the durable assembly 115C by (1) aligning a complementary coupling between the durable pneumatic assembly 105 and a disposable pump, for example, controlled by the pneumatic assembly 105, and (2) engaging a mechanism that enables a secure coupling between the disposable and durable assemblies. In one embodiment, the mechanism includes at least one tapered locking shaft coupled with at least one disposable locking carriage. The locking carriage locks the disposable assembly 113 in place by sliding across the locking shaft until it passes a spring plunger. To decouple the disposable assembly 113 from the durable assembly 115C, the spring plunger is released. Other means of coupling the durable and disposable assemblies are also contemplated by the present teachings.

[0037] Referring now to FIG. 1E, disposable assembly 113A includes components that directly contact the tissue, and / or perfusion fluid, and / or nutrients and / or medications. These components include, without limitation, a tissue container, pumps that enable the flow of perfusion fluid, medications, and nutrients, tubing, sensors, and sample collection / assessment containers. In one embodiment, disposable assembly 113A includes disposable subassembly 303, pneumatic drip assembly 305, perfusion pump assembly 307, tissue container assembly 309, tubing 311, output assembly 313, sensor 315, and sample collection device 317. In one embodiment, pneumatic drip assembly 305 drives perfusion pump assembly 307 to deliver medications and nutrients to the perfusion fluid. In one embodiment, nutrients can be delivered by one pneumatic drip pump, while medications can be delivered by another pneumatic drip pump. In one embodiment, the pneumatic drip pumps are controlled by a controller. In one embodiment, medications and / or nutrients can be delivered by a separate, remotely controlled pump not tied to the pneumatic system. The choice of pump depends on the desired delivery rate and other factors associated with the product being delivered. In one embodiment, the infusion pump can include a cassette pump designed to deliver infusion materials according to a desired flow rate and pressure. The perfusion pump assembly 307 includes at least one perfusion pump. In one embodiment, the perfusion pump enables the flow of perfusion fluid to and through the tissue. In one embodiment, the perfusion pump can include one or more cassette pumps. Other types of pumps are also contemplated by the present teachings. In one embodiment, the tissue container assembly 309 includes a removable tissue platform that isolates the tissue from the reservoir of perfusion fluid. In one embodiment, the removable tissue platform allows connection of the tissue to input and output fluid pathways. Because intubation can be performed away from the perfusion system, the tissue platform allows for initial intubation of the tissue, after which the tissue and platform are simply introduced into the perfusion system and plugged in.The tissue platform allows tissue to be positioned and secured with a removable fitting. In this way, the tissue platform fitting can simply be uncoupled from the tissue container without the need to release the cannulation when the tissue is ready for transplantation. The tissue container assembly 309 includes a sample port and various disposable sensors. The tissue container assembly 309 includes a perfusate reservoir. In one embodiment, the reservoir is replenished with tissue products, nutrients, and medications. Refilling occurs based on the volume of waste product, if any. Tubing 311 connects the various portions of the disposable assembly 113A to each other through tubes and appropriate connectors, forming a closed loop and avoiding environmental contamination. The product assembly 313 includes at least one vial for holding a product to be measured and evaluated as described herein. The vial may be transparent for visual evaluation of the product. The disposable sensor 315 may include a sensor that contacts the tissue and / or the perfusate. The sampler 317 receives the product from the tissue and makes it available for online or offline sampling. The disposable subassembly 303 includes components such as, but not limited to, an oxygenator, a hood mount, and tissue straps. The oxygenator provides oxygen to the perfusate. The hood mount provides a surface for coupling the environmental barrier to the tissue container. The tissue straps maintain the position of the tissue on the tissue platform.

[0038] Referring now to FIG. 1F, the flow and date / control / electrical connections of an exemplary configuration of a system of the present teachings are shown. In one embodiment, controller 279 controls the sequencing of events that move perfusate, medications, and nutrients from one point to another. Starting from perfusate reservoir 284, perfusate flows into and through perfusion pump 275. The pressure of the perfusate is then measured in-line by pump pressure sensor 273 before the perfusate enters oxygenator 271. The oxygenated perfusate flows into heat exchanger 285, where the temperature of the perfusate is adjusted to a desired level and then assessed by in-line sensor 291. Air bubbles are removed by air trap 293, and the in-line flow rate is measured by flow meter 295. The oxygenated, debubble-free, and thermally regulated perfusate is pumped into tissue in tissue holder 283 through a connector to which the tissue is attached. The tissue processes the perfusate by producing products. Some of the product exits the tissue through orifices in the tissue itself, such as the ureters in a kidney, and some fluid becomes available based on the process. Product exiting the tissue through the tissue orifices is pumped to a product assembly, as described herein. In one embodiment, other secreted fluid follows a fluid ramp into reservoir 284. The fluid ramp allows for a soft landing of the secreted fluid into reservoir 284 to avoid damage to the contents of the perfusion fluid. The loop continues with perfusion fluid pumped into perfusion pump 275. In one embodiment, controller 279 tracks any product that has not returned to reservoir 284. The pumping action of infusion pump 299 allows for equal amounts of perfusion fluid and nutrients / medications 297 to be added to reservoir 284. In one embodiment, the system includes many infusion pumps of various types, some specific to delivering medications and some specific to delivering nutrients. In one embodiment, controller 279 receives data from sensor 287 and activates thermal adjustment 289 based on the data. In one embodiment, controller 279 receives data from sensor 291, air trap 293, and flow meter 295 and adjusts the properties, flow rate, and possibly flow volume based on this data.In one aspect, an operator can perform manual inspection of data from the sensors and can adjust, for example, but not limited to, medications, nutrients, temperature, flow rate, oxygenation, and flow volume in the perfusion fluid to maintain tissue viability. The sensors collect data for example, but not limited to, glucose, dissolved oxygen, temperature, pH, and oxygen saturation.

[0039] 2A-2X, the means for coupling to the tissue orifice includes a cannula 24000 configured and arranged to interface with tissue at one end and with tubing of a perfusion loop at the other end. Generally, in FIGS. 2A-2X, the cannula 24000 includes a cannula body 24010 having at one end at least one cannula strut 24020 with a lumen 24030 extending therethrough such that the cannula strut 24020 is inserted into the tissue vasculature. For example, when configured for the kidney, the cannula strut is insertable into the renal artery, vein, or urethra. At the end of the cannula body 24010 opposite the cannula strut 24020 is a tubing interface 24040 configured to interface with tubing of a perfusion loop. The tubing interface 24040 may be a luer connector, a barbed connector, a locking connector, a spin-lock connector, or any other type of tubing interface known in the art. The cannula body 24010 further includes opposed shoulders 24050 extending outwardly from the sides of the cannula body 24010, the shoulders 24050 constructed and arranged to support and retain the opposed clamping arms 24060 and 24070.

[0040] The opposing clamping arms 24060 and 24070 include pivot supports 24080 extending rearward therefrom, each having a pivot bar 24090 and a locking bar 24100 configured and arranged to engage mating formations on the shoulder 24050 of the cannula body 24010, as described in more detail below. The cannula post 24020 may include a flared base 24110 where it meets the cannula body 24010, and the opposing clamping arms 24060 and 24070 may include a corresponding flare 24120 at their rear portions. The clamping arm 24070 includes clamping members 24130 along its edges where it meets the clamping arm 24060 at the point of engagement. Release tabs 24140 extend upwardly along the sides of the clamping arms 24070 such that when inward pressure is applied to the release tabs 24140, they move the clamping members 24130 away from each other, disengaging the clamping arms 24070 from the clamping arms 24060. The clamping arms 24070 may include cut-out areas 24180 therein that allow the clamping arms to have flexible areas that allow them to deflect when pressure is applied to the release tabs 24140. The clamping arms 24060 can be seen to include clamping detents 24150 along their edges where they meet the clamping arms 24070 upon engagement. When the clamping arms 24060 and 24070 are moved into engagement, the clamping detent 24150 is captured and retained by the clamping member 24130, holding the clamping arms 24060 and 24070 engaged with one another around the cannula post 24020. Applying pressure to the release tab 24140 disengages the clamping member 24130 from the clamping detent 24150, allowing the clamping arms 24060 and 24070 to separate from one another.

[0041] 2F and 2G illustrate elastomeric components that may be included to soften the contact area of ​​the cannula while providing a reliable seal between the tissue vessel and the cannula. A first elastomeric component 24200 is constructed and arranged to be received around the cannula post 24020 and to have an opening therein including a flared base 24210 that corresponds to the flare 24110 at the base of the cannula post 24020. A second elastomeric component includes a pair of elastomeric components 24220 received on the inner surface of each of the clamping arms 24060 and 24070 and including a flared base 24030 that corresponds to the flared base 24120 of the clamping arms 24060 and 24070. The second elastomeric component 24220 may include an engaging member 24240 that engages with a slot 24250 formed in the clamping arms 24060 and 24070 to help retain the second elastomeric component 24220 within the clamping arms 24060 and 24070. The first and second elastomeric components 24200 and 24220 may be formed from any suitable elastomeric material. Preferably, the first and second elastomeric components 24200 and 24220 are molded from silicone. More preferably, the first and second elastomeric components 24200 and 24220 are molded from silicone with a Shore A hardness of 10. This is a soft silicone that prevents injury to the artery and provides specific compression. This will vary with clearance depending on design requirements. Additionally, the first and second elastomeric components 24200 and 24220 may be overmolded in place or molded separately and then inserted. Preferably, when the elastomeric components 24200 and 24220 are housed around the cannula post 24020 and within the clamping arms 24060 and 24070, and the clamping arms 24060 and 24070 are in the closed position, there is a slight gap between the first and second elastomeric components. More preferably, there is approximately 0.1 to 0.2 mm of clearance between the elastomeric components 24200 and 24220.More preferably, there is about 0.15 mm of clearance between elastomeric components 24200 and 24220. This clearance allows for tissue vessels to be accommodated and tightly clamped with the desired compression while also limiting damage to the vessels.

[0042] 2H-2M, it can be seen that the shoulders 24050 of the cannula body 24010 each include a pivot slot 24260, a rear locking detent 24270, and a front locking detent 24280. The pivot bar 24090 is received within the pivot slot 24260 and allows both rotational movement of the clamping arms 24060 and 24070 and lateral sliding movement of the clamping arms 24060 and 24070 forward and rearward parallel to the central axis of the cannula post 24020. When the clamping arms 24060 and 24070 are in the open position and pivoted rearward, the locking bar 24100 can be releasably engaged with the rear locking detent 24270.

[0043] 2N-2V illustrate a mode of operation of the cannula 24000 of the present disclosure. The free end of the tissue vessel 24300 is received over the first elastomeric component 24200 and cannula post 24020 and pushed against the flared base 24210 while the clamping arms 24060 and 24070 are in the open position and pivoted rearward. The clamping arms 24060 and 24070 are then pivoted to the forward, closed position where the locking bar 24100 is positioned adjacent the front face of the front locking detent 24280. The clamping arms 24060 and 24070 are brought together and compressed such that the clamping member 24130 engages the clamping detent 24150 and compresses the second elastomeric component 24220 against the outer surface of the vessel 24300, which in turn compresses the inner surface of the vessel against the first elastomeric component 24200 and cannula post 24020. The clamping arms 24060 and 24070, now in the closed, latched position, are slid rearward relative to the cannula body 24010 such that the flared end 24230 contacts and compresses the vessel 24300 against the flared base 24210, sealing and retaining the vessel relative to the cannula. As the clamping arms 24060 and 24070 slide rearward, the locking bar 24100 enters and engages the locking detent 24280, and the pivot bar 24090 slides into the pivot slot 24070 so that the flat sides of the pivot bar 24090 engage the flat walls on the pivot slot 24070. In this manner, the pivot bar 24090, locking bar 24100, and engaged clamping arms 24060 and 24070 cooperate to maintain the cannula in a clamped, sealed position about the vessel 24300.

[0044] 3A-3E, in one embodiment, the means for coupling to the tissue orifice includes a cannula 18000 configured and arranged to interface with tissue at one end, configured and arranged to interface with tubing of a perfusion loop at the other end, and optionally configured and arranged to interface with an additional cannula 18000 disposed at a third end. Generally, in FIGS. 3A-3E, the cannula 18000 includes a cannula body 18010 having at least one cannula strut 18012 at one end thereof, the cannula strut 18012 being insertable into a renal artery, vein, or urethra. Connected to the cannula body 18010 using a T-joint interface 18275 located at a first end of the cannula body 18010 is a T-joint 18200. The T-fitting 18200 can have three interfaces: a perfusion loop interface 18260 configured to interface with the tubing of a perfusion loop; a primary cannula interface 18270 configured to interface with the cannula body 18010; and a secondary cannula interface 18280 configured to interface with or be capped by another cannula 18000. The three interfaces of the T-fitting 18200 interface with their respective components through multiple connector fittings 18290. The multiple connector fittings 18290 can be luer connectors, luer cap screws, barbed connectors, locking connectors, spin-lock connectors, or any other type of interface connection known in the art.

[0045] Opposing clamping arms 18110 and 18111 include pivot supports 18045 extending rearwardly therefrom and have pivot bars 18046 configured to engage pivot slots 18041 located at the ends of shoulders 18040 extending from the cannula body 18010. The cannula post 18012 may include a flared base 18050 where it meets the cannula body 18010, and the opposing clamping arms 18110 and 18111 may include a corresponding flared shape. The clamping arm 18111 includes clamping members 18120 along its edges where it meets the clamping arm 18110. The clamping arms 18110 can be seen to include clamping detents 18125 along their edges where they encounter the clamping arms 18111 upon engagement. When the clamping arms 18110 and 18111 are moved into engagement, the clamping detents 18125 are captured and retained by the clamping members 18120, holding the clamping arms 18110 and 18111 engaged with one another around the cannula post 18012. The clamping arms 18110 have outwardly extending collar posts 18137, and the clamping arms 18111 have outwardly extending release tabs. The collar post 18137 has a collar post detent 18138 configured to interface with and lock with the tray 18537. Applying pressure to release tab 18135 disengages clamping member 18120 from clamping detent 18125, allowing clamping arms 18110 and 18111 to separate from one another. The cannula may be configured to be 3-9 mm.

[0046] 3B illustrates elastomeric components 18015 and 18115 that may be included to soften the contact area of ​​the cannula 18000 while providing a secure seal between the tissue vessel and the cannula 18000. A first elastomeric component 18015 is constructed and arranged to be received around the cannula post 18012 and have an opening therein that includes a flare that corresponds to the flared base 18050 of the cannula post 18012. A second elastomeric component 18115 is received by each of the clamping arms 18110 and 18111 and has a flare that corresponds to the flared base 18050 of the cannula post 18012. The first and second elastomeric components 18015 and 18115 may be formed from any suitable elastomeric material. Preferably, the first and second elastomeric components 18015 and 18115 are molded from silicone. More preferably, the first and second elastomeric components 18015 and 18115 are molded from silicone with a Shore A hardness of 10. This is a soft silicone that prevents injury to the artery and provides specific compression. This varies with clearance depending on design requirements. Furthermore, the first and second elastomeric components 18015 and 18115 may be molded in place or molded separately and then inserted. Preferably, when the elastomeric components 18015 and 18115 are housed around the cannula post 18012 and within the clamping arms 18110 and 18111, and the clamping arms 18110 and 18111 are in the closed position, there is a slight gap between the first and second elastomeric components 18015 and 18115. More preferably, there is approximately 0.1 to 0.2 mm of clearance between the elastomeric components 18115 and 18111. More preferably, there is a clearance of about 0.15 mm between elastomeric components 18015 and 18115. This clearance allows for tissue vessels to be accommodated and tightly clamped with the desired compression while also limiting damage to the vessels.

[0047] 3C , an exploded view of an exemplary cannula 18000 is illustrated. This exploded view reveals the contents of the cannula 18000. In some embodiments, the cannula body 18010 is configured to accommodate a first elastomeric component 18015 that can be withdrawn from the cannula body 18015. The clamping arms 18110 and 18111 are similarly configured to accommodate a second elastomeric component 18115. Once the clamping arms 18110 and 18111 and the cannula body 18010 are mated with their respective elastomeric components 18015 and 18115, the clamping arms 18110 and 18110 can be coupled to the cannula body 18010. This is accomplished by snapping the pivot bar 18046 into the pivot slot 18041. The T-joint 18260 has three interfaces: a perfusion loop interface 18260, a primary cannula interface 18270, and a secondary cannula interface 18280. The cannula body 18010 similarly has one interface: a T-joint interface 18275. Each interface is configured to interact with a connector fitting 18290 to interface with its respective counterpart. For example, a threaded luer fitting may be used to interface the primary cannula interface 18270 with the T-joint interface 18275 of the cannula body 18010. In another example, the secondary cannula interface 18280 may mate with a luer cap screw, or it may mate with a threaded luer fitting to connect to the perfusion loop interface of another cannula.

[0048] 3D-3E, cannula body 18010 includes shoulder 18040, pivot slot 18041, detent guide 18043, and cannula body pocket 18044. When clamping arms 18110 and 18111 are disengaged from one another and cannula 18000 is moved to engage tissue, clamping arms 18110 and 18111 are configured to rotate rearwardly by pivot bar 18046 engaging pivot slot 18041. Rotating clamping arms 18110 and 18111 rearward causes collar detent 18042 inside pivot support 18045 to lock into cannula body pocket 18044 and along detent guide 18043 near pivot slot 18041. Cannula body pocket 18044 allows clamping arms 18110 and 18110 to be secured in the open position without the need to lock them as depicted in Figures 5A-5X.

[0049] Similarly, as described above with respect to the previous embodiment, the operating mode of the cannula 18000 of the present disclosure includes the free end of the tissue vessel 18612 being received on the first elastomeric component 18015 and the cannula post 18012 and being pushed toward and into contact with the flared base 18050 of the cannula post 18012, while the clamping arms 18110 and 18111 are locked within the cannula body pocket 18044. The clamping arms 18110 and 18111 are then pivoted to a forward, closed position where the clamping members 18120 engage the clamping detents 18125 and compress the second elastomeric component 18115 against the outer surface of the tissue vessel 18613, which itself compresses the inner surface of the tissue vessel 18613 against the first elastomeric component 18015 and the cannula post 18012. With the clamping arms 18110 and 18111 in the closed, latched position, the tissue vessel 18613 is compressed to help seal and retain the tissue vessel 18613 in relation to the cannula 18000.

[0050] Perfusion fluid may flow through the perfusion loop interface 18260, then upward through the primary cannula interface 18270, through the cannula body 18010, and into the tissue to which the cannula 1800 is coupled. Perfusion fluid may similarly flow through the perfusion loop interface 18260, then through the secondary cannula interface 18280, and into a secondary cannula attached to the first cannula 18000 using the secondary cannula interface. Alternatively, the secondary cannula interface 18280 may be capped, such that perfusion fluid flow is only through the perfusion loop interface 18260 and into one cannula 18000 connected to the T-joint 18200. The design of the T-joint 18200 allows the size of the cannula 18000 to be more compact compared to the cannulas depicted in FIGS. 2A-2V.

[0051] 4A-4E, in one embodiment, the means for coupling to the tissue orifice includes a cannula 4000 configured and arranged to interface with tissue at one end and with tubing of a perfusion loop at the other end. Generally, in FIGS. 4A-4E, the cannula 4000 includes a cannula body 4010 having at least one cannula strut 4012 at one end thereof, the cannula strut 4012 being insertable into a renal artery, vein, or urethra. At the opposite end of the cannula body 4010 is a cannula interface 4270 that allows the cannula 4000 to be coupled to a perfusion loop. The cannula interface 4270 may be configured for interface with multiple connector fittings, including, but not limited to, a luer connector, a luer cap screw, a barbed connector, a locking connector, a spin-lock connector, or any other type of interface connection known in the art.

[0052] Opposing clamping arms 4110 and 4111 include pivot supports 4045 extending rearwardly therefrom. A pivot bar 4046 configured to engage the pivot support 4045 is located on one end of the shoulder 4040 extending from the clamp support platform 4042. A clamping member 4120 extends outwardly from the cannula body 4010 and has a slot therein for holding the clamping arms 4110 and 4111 in a closed, clamping position when the clamping arms 4110 and 4111 are rotated to an upward position against the cannula post 4012. When the clamping arms 4110 and 4111 are moved into engagement, they are captured and retained by the clamping member 4120 and held in engagement with one another around the cannula post 4012. The cannula body may be configured to have a diameter of 3 to 9 mm.

[0053] 4A and 4B illustrate elastomeric components 4015 and 4115 that may be included to soften the contact area of ​​the cannula 4000 while providing a secure seal between the tissue vessel and the cannula 4000. A first elastomeric component 4015 is constructed and arranged to be received around the cannula post 4012 and to have an opening therein that includes a flare that corresponds to the flared base of the cannula post 4012. A second elastomeric component 4115 is received by each of the clamping arms 4110 and 4111. The first and second elastomeric components 4015 and 4115 may be formed from any suitable elastomeric material. Preferably, the first and second elastomeric components 4015 and 4115 are molded from silicone. More preferably, the first and second elastomeric components 4015 and 4115 are molded from silicone with a Shore A hardness of 10. This is a soft silicone that prevents damage to the artery and provides specific compression. This varies with clearance depending on design requirements. Furthermore, the first and second elastomeric components 4015 and 4115 may be molded in place or molded separately and then inserted. The elastomeric component 4115 may include detents 4116 that are received in corresponding openings in the clamping arms 4110 and 4111 to help maintain it in place. Preferably, when the elastomeric components 4015 and 4115 are received around the cannula post 4012 and within the clamping arms 4110 and 4111, there is a slight gap between the first and second elastomeric components 4015 and 4115 when the clamping arms 4110 and 4111 are in the closed position. More preferably, there is approximately 0.1 to 0.2 mm of clearance between the elastomeric components 4015 and 4115. More preferably, there is a clearance of about 0.15 mm between elastomeric components 4015 and 4115. This clearance allows for tissue vessels to be accommodated and tightly clamped with the desired compression while also limiting damage to the vessels.

[0054] 4A , an exploded view of exemplary cannula 4000 is illustrated. This exploded view reveals the contents of cannula 4000. In some embodiments, cannula body 4010 is configured to accommodate a first elastomeric component 4015 that can be retracted from cannula post 4012. Clamping arms 4110 and 4111 are similarly configured to accommodate a second elastomeric component 4115. Once clamping arms 4110 and 4111 and cannula body 4010 are mated with their respective elastomeric components 4015 and 4115, clamping arms 4110 and 4110 can be coupled to cannula body 4010. This is accomplished by snapping pivot bar 4046 into pivot slot 4045.

[0055] 4B-4C, a mode of operation of cannula 4000 is disclosed in which the free end of the tissue vessel is received on first elastomeric component 4015 and cannula post 4012 and forced toward and into contact with the flared base of cannula post 4012, while clamping arms 4110 and 4111 are rotated to an open position, as described above with respect to the previous embodiment. As can be seen in FIG. 4C, clamping arms 4110 and 4111 are then pivoted to a forward, closed position, where clamping member 4040 engages clamping arms 4110 and 4111, compressing second elastomeric component 4115 against the outer surface of the tissue vessel, which in turn compresses the inner surface of the tissue vessel against first elastomeric component 4015 and cannula post 4012.

[0056] With clamping arms 4110 and 4111 in the closed, latched position, clamping dial 4021, which can be seen housed about cannula body 4010, is rotatable and linearly displaced by mating thread formations 4022 and 4023, respectively, on the interior of clamping dial 4021 and about cannula body 4010. As best seen in FIG. 4D , rotation in the direction of arrow 4026 (which can be in either direction depending on whether thread formations 4022 and 4023 are formed as right- or left-handed threads) causes linear displacement of clamping dial 4021 relative to cannula body 4010. Linear displacement of the clamping dial 4021 applies pressure to the clamp support platform 4042, displacing it in the direction of arrow 4028, which causes displacement of the clamping arms 4110 and 4111, clamping the bottom surfaces of the clamping arms 4110 and 4111 downward against the flared base of the cannula post 4012 and compressing the tissue vessels to assist in sealing and retaining the tissue relative to the cannula 4000, as seen in FIG. 4E . Rotation of the clamping dial 4021 in the opposite direction reverses the displacement, allowing the tissue vessels to be released from compression. A key 4024 positioned on the cannula body 4010 is slidably received within a keyway 4025 to prevent rotation of the clamp support platform 4042 relative to the cannula body 4010 during rotation of the clamping dial 4021 and ensure smooth linear displacement of the clamp support platform 4042.

[0057] 5A-5D, in one embodiment, the means for coupling to the tissue orifice includes a cannula 5000 configured and arranged to interface with tissue at one end and with tubing of a perfusion loop at the other end. Generally, the cannula 5000 includes a cannula body 5010 having at least one tissue interface pad 5013 at one end thereof. The tissue interface pad 5013 is shown as having an elongated configuration to receive the distal ends of one or more vessels extending from the tissue to be perfused. At the opposite end of the cannula body 5010 is a cannula interface 5270 that allows the cannula 5000 to be coupled to the perfusion loop. The cannula interface 5270 is shown here as having two ends that may be configured for interface with multiple connector fittings, including, but not limited to, a luer connector, a luer cap screw, a barbed connector, a locking connector, a spin-lock connector, or any other type of interface connection known in the art. Those skilled in the art will recognize that the cannula interface 5270 may be singular, as shown in other embodiments illustrated herein.

[0058] The opposing clamping arms 5110 and 5111 include pivot supports 5045 extending rearwardly therefrom. A pivot bar 5046 configured to engage the pivot support 5045 is located on one end of a shoulder 5040 extending from the clamp support platform 5042.

[0059] The tissue interface pad 5013 may be formed as a single elastomeric component. Additional elastomeric components 5015 and 5115 may be included to soften the contact area of ​​the cannula 5000 while providing a secure seal between the tissue vessel and the cannula 5000. First and second elastomeric components 5015 and 5115 are housed by respective clamping arms 5110 and 5111. The elastomeric components may be formed from any suitable elastomeric material. Preferably, the elastomeric components are molded from silicone. More preferably, the elastomeric components are molded from silicone with a Shore A hardness of 10. This is a soft silicone that prevents injury to the artery and provides specific compression. This will vary with clearance depending on design requirements. Furthermore, the elastomeric components may be molded in place or molded separately and then inserted. Detents 5116 may be provided on the elastomeric component to be received in corresponding openings in clamping arms 5110 and 5111 to help maintain the installed position.

[0060] 5D , in some embodiments, the cannula body 5010 is configured to receive one or more cannula posts 5012 against the tissue support pad 5013, where additional elastomeric components can be retracted onto the cannula posts 5012. The inclusion of the cannula posts 5012 in this configuration is optional, as these cannula posts are not required for clamping against the distal end of the vessel. The clamping arms 5110 and 5111 are similarly configured to receive the elastomeric component 5115. Preferably, the elastomeric component 4013 is received around the cannula post 5012 and within the clamping arms 5110 and 5111, and when the clamping arms 5110 and 5111 are in the closed position, there is a slight gap between the first and second elastomeric components 5115 and any cannula posts 5012 and 5115. More preferably, there is about 0.1-0.2 mm of clearance between the elastomeric component 5115 and any cannula posts 5012. More preferably, there is about 0.15 mm of clearance between the elastomeric component 5115 and any cannula posts 5012. This clearance allows for tissue vessels to be accommodated and tightly clamped with the desired compression while also limiting damage to the vessels.

[0061] 5B-5D, a mode of operation of cannula 5000 is disclosed in which the free end of the tissue vessel is received on tissue interface pad 5113 or on any adjacent cannula posts 5012, as described above with respect to the previous embodiment, while clamping arms 5110 and 5111 are rotated to an open position as illustrated in FIG. 5D. As can be seen in FIG. 5B, clamping arms 5110 and 5111 are then pivoted to a forward, closed position, where elastomeric components 5015 and 5115 within clamping arms 5110 and 5111 compress them against the outer surface of the tissue vessel, which itself compresses the inner surface of the tissue vessel against cannula posts 5012, if used.

[0062] With clamping arms 5110 and 5111 in the closed position, clamping dial 5021, which can be seen housed about cannula body 5010, is rotatable and linearly displaced by mating thread formations 5022 and 5023, respectively, on the interior of clamping dial 5021 and about cannula body 5010. As best seen in FIG. 5B , rotation in the direction of arrow 5026 (which can be in either direction depending on whether thread formations 5022 and 5023 are formed as right- or left-handed threads) causes linear displacement of clamping dial 5021 relative to cannula body 5010. Linear displacement of clamping dial 5021 applies pressure to clamp support platform 5042 via detents 5043 extending from fingers on clamping dial 5021 that engage openings in clamp support platform 5042, thereby displacing it in the direction of arrow 5028, which in turn causes displacement of clamping arms 5110 and 5111 in the direction of arrow 5030, clamping the bottom surfaces of clamping arms 5110 and 5111 downward against tissue interface pad 5113, compressing the tissue vessels and assisting in sealing and retaining the tissue in relation to cannula 5000, as seen in FIG. 5C . Rotation of clamping dial 5021 in the opposite direction reverses the displacement, allowing release of compression of the tissue vessels.

[0063] 6A-6B, in one embodiment, the means for coupling to the tissue orifice includes a cannula 6000 configured and arranged to interface with tissue at one end and with tubing of a perfusion loop at the other end. Generally, the cannula 6000 includes a cannula body 6010 having at least one tissue interface pad 6013 at one end thereof. While the tissue interface pad 6013 is shown as having an elongated configuration to receive the terminal ends of one or more vessels extending from the tissue to be perfused, the tissue interface pad 6013 may also be generally circular for interfacing with a single vessel. At the opposite end of the cannula body 6010 is a cannula interface 6270 that allows the cannula 6000 to be connected to a perfusion loop. Cannula interface 6270 is shown here as having two ends that may be configured for interfacing with multiple connector fittings, including, but not limited to, a luer connector, a luer cap screw, a barbed connector, a locking connector, a spin-lock connector, or any other type of interfacing connection known in the art. One skilled in the art will recognize that cannula interface 6270 may be singular, as shown in other embodiments illustrated herein.

[0064] The opposing clamping arms 6110 and 6111 include pivot supports 6045 extending rearwardly therefrom. A pivot bar 6046 configured to engage the pivot supports 6045 is located on one end of a shoulder 6040 extending from the clamp support platform 6042.

[0065] The tissue interface pad 6013 may be formed as a single elastomeric component. Additional elastomeric components 6015 and 6115 may be included to soften the contact area of ​​the cannula 6000 while providing a secure seal between the tissue vessel and the cannula 6000. First and second elastomeric components 6015 and 6115 are housed by respective clamping arms 6110 and 6111. The elastomeric components may be formed from any suitable elastomeric material. Preferably, the elastomeric components are molded from silicone. More preferably, the elastomeric components are molded from silicone with a Shore A hardness of 10. This is a soft silicone that prevents injury to the artery and provides specific compression. This will vary with clearance depending on design requirements. Furthermore, the elastomeric components may be molded in place or molded separately and then inserted. Detents 6116 may be provided on the elastomeric component to be received in corresponding openings in the clamping arms 6110 and 6111 to help maintain the installed position.

[0066] As described above with respect to the previous embodiment, a mode of operation of the cannula 6000 is disclosed in which the free end of the tissue vessel is received on the tissue interface pad 6113. As can be seen in FIG. 6B , the clamping arms 6110 and 6111 are pivoted to a forward, closed position where the elastomeric components 6015 and 6115 within the clamping arms 6110 and 6111 press against the outer surface of the tissue vessel, which in turn presses the distal end of the tissue vessel against the tissue interface pad 6013.

[0067] With the clamping arms 6110 and 6111 in the closed position, the clamping lock 6021, which can be seen housed within the bottom of the cannula body 6010, includes a detent 6023 and a ramp 6022 that serves to engage a locking tab 6024 on the end of the clamping arms 6110 and 6111. Once the clamping arms 6110 and 6111 are rotated upward to the closed position, the locking tab moves along the ramp 6023, displacing the clamping lock 6021 downward until the tab reaches its fully closed position, at which point the locking tab 6024 drops off the ramp 6023 behind the detent 6023 and retains the clamping arms 6110 and 6111 from rotating out of the closed position. To remove the distal end of tissue from the cannula 6000, the user can press the release tab 6025 to deflect the end of the clamping lock 6021 downward until the detent 6023 releases the locking tab 6024, thereby rotating the clamping arms 6110 and 6111 downward to the open position.

[0068] 7A-7C includes many features corresponding to the embodiments described above. This arrangement is shown primarily to illustrate that the elongated tissue interface pad 7013 can be used with a single cannula interface 7270. Those skilled in the art will recognize that any combination of the various features shown in the multiple embodiments disclosed herein is for illustrative purposes only, and that the various features can be recombined in virtually any combination with each other and still fall within the scope of the present disclosure.

[0069] In all disclosed embodiments, perfusion fluid may flow from the perfusion loop into the cannula interface, then upward through a lumen in the cannula body, and, if used, through a lumen in the cannula strut, into the tissue to which the cannula is connected. In embodiments including a double-ended cannula interface, perfusion fluid may flow from the perfusion loop through a first cannula interface into the cannula body and through a secondary cannula interface to further supply a secondary cannula attached to the first cannula using the secondary cannula interface. Alternatively, the secondary cannula interface may be capped, and perfusion fluid flow will only enter through the cannula interface and into one of the cannula bodies connected to the T-piece.

[0070] Referring back to FIG. 1F, starting from fluid in a reservoir (not shown) within the tissue container, perfusion fluid exits tissue container 284 in tubing, enters perfusion pump 275, passes through perfusion pump 275, and is pumped from the pump. The perfusion fluid proceeds in the direction of arrow 203, past sensor 301, pressure sensor 273, and possibly other sensors, into oxygenator 271, and into heat exchange area 371. The perfusion fluid exits heat exchange area 285, passes sensor 291, e.g., a pressure sensor, and enters bubble trap 293. The perfusion fluid exits bubble trap 293, passes durable flow meter 295, and enters the cannulated tissue through connector 283. Fluid associated with tissue function drains into the reservoir, and closed-loop perfusion fluid movement continues. The vent line includes a sterile filter vented to atmosphere. In one embodiment, one end of the vent line is coupled to the tissue container, and the other end is coupled to a pump used to set up a slight negative pressure just below atmospheric pressure inside the tissue container. In one embodiment, pressure within the tissue container, which is slightly less than venous pressure, mimics interstitial pressure, which is slightly negative relative to venous pressure, promoting intravenous integrity and preventing venous kinking or collapse. Other flow paths are also contemplated by exemplary configurations of the present teachings. Alternative flow paths can be initiated "manually" or automatically. In one embodiment, possible flow paths can be displayed in a user interface, and the user can select a flow path. In one embodiment, a controller can access the recipe and / or user-selected flow path and open or close valves associated with the pneumatic assembly to move perfusion fluid and / or infused materials through paths that may differ from those depicted.

[0071] Embodiments of the present disclosure include the following: Embodiment 1: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold at least one vessel of the tissue to be perfused in compression about the cannula strut; A cannula comprising: Embodiment 2: A cannula as described in embodiment 1, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel of the tissue to be perfused and the cannula support. Embodiment 3: A first elastomeric component positioned around the cannula post; a second elastomeric component positioned within each of the clamping arms; 3. The cannula of embodiment 2, further comprising: Embodiment 4: The first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms. 4. The cannula of embodiment 3. Embodiment 5: A cannula as described in embodiment 3, wherein the first elastomer component is inserted onto the cannula post and the second elastomer component is inserted into each of the clamping arms. Embodiment 6: The cannula of embodiment 3, wherein the clamping arms compress the second elastomeric component against the outer surface of the vessel, which itself compresses the inner surface of the vessel against the first elastomeric component. Embodiment 7: The cannula of embodiment 3, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms. Embodiment 8: The clamping arms press the flared end of the second elastomeric component against an outer surface of the vessel, which itself presses the inner surface of the vessel against the flared end of the first elastomeric component. 8. A cannula as described in embodiment 7. Embodiment 9: a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising 3. The cannula of embodiment 2, wherein in the clamping position, the clamping members engage the clamping detents to retain the clamping arms. Embodiment 10: The cannula of embodiment 9, wherein pressure on the clamping arms disengages them from the clamping detents. Embodiment 11: Opposing shoulders extending from an outer surface of the cannula body and including a pivot slot, a front locking detent, and a rear locking detent; 2. The cannula of embodiment 1, further comprising: Embodiment 12: The cannula of embodiment 11, further comprising a pivot bar and a locking bar at the rear end of each of the clamping arms, the pivot bar pivotally received within the pivot slot, the locking bar received and retained within the rear locking return detent when the clamping arms are in the open position, and the locking bar received and retained within the front locking return detent when the clamping arms are in the clamping position. Embodiment 13: The cannula of embodiment 12, wherein in the open position, the two clamping arms are pivoted rearward relative to the cannula body, and in the clamping position, the clamping arms are pivoted forward relative to the cannula body, engaging each other around the vessel of the tissue to be perfused and the cannula support. Embodiment 14: A first elastomeric component positioned around the cannula post; a second elastomeric component positioned within each of the clamping arms; 12. The cannula of embodiment 11, further comprising: Embodiment 15: The first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms. 15. A cannula as described in embodiment 14. Embodiment 16: The cannula of embodiment 14, wherein the first elastomer component is inserted onto the cannula post and the second elastomer component is inserted into each of the clamping arms. Embodiment 17: The cannula of embodiment 14, wherein the clamping arms compress the second elastomeric component against the outer surface of the vessel, which itself compresses the inner surface of the vessel against the first elastomeric component. Embodiment 18: The cannula of embodiment 14, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms. Embodiment 19: The cannula of embodiment 18, wherein the clamping arms press the flared end of the second elastomeric component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the flared end of the first elastomeric component. Embodiment 20: a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising In the clamping position, the clamping members engage the clamping detents to retain the clamping arms. 13. A cannula as described in embodiment 12. Embodiment 21: The cannula of embodiment 20, wherein pressure on the clamping arms disengages them from the clamping detents. Embodiment 22: The cannula of embodiment 20, wherein in the clamping position, the clamping members are slid rearward to engage the locking bar with the front locking detent. Embodiment 23: The cannula of embodiment 18, wherein in the clamping position, the clamping members are slid rearward to engage the locking bar with the front locking detent. Embodiment 24: The cannula of embodiment 23, wherein the clamping arms press the flared end of the second elastomeric component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the flared end of the first elastomeric component. Embodiment 25: The cannula of embodiment 1, wherein the tubing interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 26: The cannula of embodiment 12, wherein the tubing interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 27: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a tissue interface support at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in a compressed state together with the tissue interface support; A cannula comprising: Embodiment 28: A cannula as described in embodiment 27, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel and the tissue interface support of the tissue to be perfused. Embodiment 29: The cannula of embodiment 27, wherein the tissue interface support is substantially circular. Embodiment 30: A cannula according to embodiment 27, wherein the tissue interface support is elongated to accommodate two or more vessels of the tissue to be perfused. Embodiment 31: An elastomeric component positioned within each of the clamping arms; 28. The cannula of embodiment 27, further comprising: Embodiment 32: The elastomeric component is overmolded into each of the clamping arms. A cannula as described in embodiment 31. Embodiment 33: A cannula as described in embodiment 31, wherein the elastomeric component is inserted into each of the clamping arms. Embodiment 34: At least one cannula strut with a lumen extending therethrough, housed adjacent said tissue support interface. 32. The cannula of embodiment 31, further comprising: Embodiment 35: A cannula as described in embodiment 34, wherein the clamping arms press the elastomeric component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the cannula posts. Embodiment 36: The cannula of embodiment 34, wherein the cannula strut has an elastomeric component around its outer surface. Embodiment 37: A clamp support platform including a pivot bar housed around the cannula body and supported at its opposite end in a shoulder. further comprising 28. The cannula of embodiment 27, wherein the first and second clamping arms have pivot ends rotatably housed around the pivot bar. Embodiment 38: The cannula of embodiment 37, wherein the clamp support platform is linearly movable along a linear axis of the cannula body. Embodiment 39: A clamping dial rotatable about the cannula body, the rotation causing linear displacement of the clamping dial along the cannula body. 38. The cannula of embodiment 37, further comprising: Embodiment 40: A cannula as described in embodiment 39, wherein linear displacement of the clamping dial similarly causes linear displacement of the clamp support platform and the clamping arms attached thereto, thereby retracting the clamping arms into contact with the tissue support platform. Embodiment 41: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessel of the tissue to be perfused in compression around the cannula strut; A cannula comprising: Embodiment 42: A cannula as described in embodiment 41, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel of the tissue to be perfused and the cannula support. Embodiment 43: A first elastomeric component positioned around the cannula post; a second elastomeric component positioned within each of the clamping arms; 42. The cannula of embodiment 41, further comprising: Embodiment 44: The first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms. A cannula as described in embodiment 43. Embodiment 45: A cannula as described in embodiment 43, wherein the first elastomer component is inserted onto the cannula support and the second elastomer component is inserted into each of the clamping arms. Embodiment 46: A cannula as described in embodiment 43, wherein the clamping arms press the second elastomer component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the first elastomer component. Embodiment 47: A cannula as described in embodiment 43, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms. Embodiment 48: The clamping arms press the flared end of the second elastomeric component against an outer surface of the vessel, which itself presses the inner surface of the vessel against the flared end of the first elastomeric component. A cannula as described in embodiment 47. Embodiment 49: a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising 42. The cannula of embodiment 41, wherein in the clamping position, the clamping members engage with the clamping detents to retain the clamping arms. Embodiment 50: The cannula of embodiment 49, wherein pressure on the clamping arms disengages them from the clamping detents. Embodiment 51: Opposing shoulders extending from an outer surface of the cannula body and including a pivot slot, a front locking detent, and a rear locking detent. 42. The cannula of embodiment 41, further comprising: Embodiment 52: The cannula of embodiment 41, wherein the tubing interface is an interface selected from the group consisting of a T-connector, a Luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 53: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; primary cannula interface; secondary cannula interface; perfusion loop interface; With T-joints; a T-joint interface at a first end of the cannula body; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessel of the tissue to be perfused in compression around the cannula strut; A cannula comprising: Embodiment 54: The cannula of embodiment 53, wherein the primary cannula interface is configured for connection with the cannula. Embodiment 55: A cannula as described in embodiment 53, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula. Embodiment 56: The cannula of embodiment 53, wherein the perfusion loop interface is configured for connection with the perfusion loop. Embodiment 57: The cannula described in embodiment 53, wherein the T-joint interface is configured for connection with a T-joint. Embodiment 58: A cannula as described in embodiment 53, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel of the tissue to be perfused and the cannula support. Embodiment 59: A first elastomeric component positioned around the cannula post; a second elastomeric component positioned within each of the clamping arms; 59. The cannula of embodiment 58, further comprising: Embodiment 60: The first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms. A cannula as described in embodiment 59. Embodiment 61: A cannula as described in embodiment 59, wherein the first elastomer component is inserted onto the cannula support and the second elastomer component is inserted into each of the clamping arms. Embodiment 62: A cannula as described in embodiment 59, wherein the clamping arms press the second elastomer component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the first elastomer component. Embodiment 63: The cannula described in embodiment 59, wherein the cannula strut has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula strut, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms. Embodiment 64: The clamping arms press the flared end of the second elastomeric component against an outer surface of the vessel, which itself presses the inner surface of the vessel against the flared end of the first elastomeric component. A cannula as described in embodiment 63. Embodiment 65: A cannula as described in embodiment 64, wherein the clamping arms press the second elastomer component against the outer surface of the vessel, which itself presses the inner surface of the vessel against the first elastomer component, and wherein the elastomer component has a flared end corresponding to the flared base of the clamping arms. Embodiment 66: a clamping detent on the first set of clamping arms; a collar post on the first set of clamping arms; a clamping member on the second set of clamping arms; and a release tab on the second set of clamping arms; further comprising 64. A cannula as described in embodiment 63, wherein in the clamping position, the clamping member engages with the clamping detent to retain the clamping arm. Embodiment 67: The cannula of embodiment 66, wherein pressure on the release tab disengages the clamping members from the clamping detents. Embodiment 68: The cannula of embodiment 66, wherein the collar post has a collar post detent configured to couple to a tray. Embodiment 69: A shoulder set extending from an outer surface of the cannula body, wherein each shoulder in the shoulder set has a pivot slot, a detent guide, and a cannula body pocket. 54. The cannula of embodiment 53, further comprising: Embodiment 70: A set of pivot supports at the rear end of each of the clamping arms, the pivot supports having a pivot bar pivotally received in the pivot slot. 70. The cannula of embodiment 69, further comprising: Embodiment 71: At least one collar detent positioned inside the pivot support, the collar detent being received by the detent guide and retained within the cannula body pocket when the clamping arms are in the clamping position. 71. The cannula of embodiment 70, further comprising: Embodiment 72: A cannula as described in embodiment 71, wherein in the open position the two clamping arms are pivoted rearward relative to the cannula body, and in the clamping position the clamping arms are pivoted forward relative to the cannula body, engaging each other around the vessel of the tissue to be perfused and the cannula support. Embodiment 73: The cannula of embodiment 53, wherein the perfusion loop interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 74: The cannula of embodiment 53, wherein the primary cannula interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 75: The cannula of embodiment 53, wherein the secondary cannula interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 76: The cannula of embodiment 53, wherein the T-junction interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector. Embodiment 77: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; primary cannula interface; secondary cannula interface; perfusion loop interface; With T-joints; a T-joint interface at a first end of the cannula body; a tissue support interface configured to receive a distal end of the vessel in the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in compression while in contact with the tissue support interface; A cannula comprising: Embodiment 78: A cannula according to embodiment 77, wherein the tissue support interface is substantially circular. Embodiment 79: A cannula according to embodiment 77, wherein the tissue support interface is elongated. Embodiment 80: The cannula of embodiment 77, wherein the primary cannula interface is configured for connection with the cannula. Embodiment 81: The cannula described in embodiment 77, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula. Embodiment 82: The cannula of embodiment 77, wherein the perfusion loop interface is configured for connection with the perfusion loop. Embodiment 83: The cannula described in embodiment 77, wherein the T-joint interface is configured for connection with a T-joint. Embodiment 84: A cannula as described in embodiment 77, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel and tissue support interface of the tissue to be perfused. Embodiment 85: a first elastomeric component positioned similarly to said tissue support interface; a second elastomeric component positioned within each of the clamping arms; 85. The cannula of embodiment 84, further comprising: Embodiment 86: A cannula as described in embodiment 85, wherein the first elastomer component is overmolded onto the cannula strut and the second elastomer component is overmolded in the same manner as the tissue support interface. Embodiment 87: A cannula as described in embodiment 85, wherein the first elastomer component is inserted in the same manner as the tissue support interface and the second elastomer component is inserted into each of the clamping arms. Embodiment 88: A cannula for connecting a vessel of a tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; a perfusion loop interface at a first end of the cannula body; a tissue support interface at a second end of the cannula body configured to receive a distal end of the vessel in the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in compression while in contact with the tissue support interface; A cannula comprising: Embodiment 89: The cannula of embodiment 88, wherein the tissue support interface is substantially circular. Embodiment 90: The cannula of embodiment 88, wherein the tissue support interface is elongated. Embodiment 91: The perfusion loop interface further comprises: a T-joint having a primary cannula interface and a secondary cannula interface; 89. The cannula of embodiment 88, comprising: Embodiment 92: The cannula described in embodiment 91, wherein the primary cannula interface is configured for connection with the cannula. Embodiment 93: A cannula as described in embodiment 91, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula. Embodiment 94: A cannula as described in embodiment 88, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body. Embodiment 95: A clamping lock adjacent the second end of the cannula body; and locking tabs at the distal ends of the two clamping arms; wherein the clamping lock engages the locking tab to retain the clamping arms in the clamping position. A cannula as described in embodiment 94. Embodiment 96: A cannula as described in embodiment 95, wherein the clamping lock has two deflectable arms with detents thereon, the arms being deflected by the locking tabs as the clamping arms are rotated from the open position to the closed position, the detents engaging the locking tabs to retain the clamping arms in the clamping position. Embodiment 97: a first elastomeric component positioned similarly to said tissue support interface; a second elastomeric component positioned within each of the clamping arms; 89. The cannula of embodiment 88, further comprising: Embodiment 98: A cannula as described in embodiment 97, wherein the first elastomer component is overmolded onto the cannula strut and the second elastomer component is overmolded in the same manner as the tissue support interface. Embodiment 99: A cannula as described in embodiment 97, wherein the first elastomer component is inserted in the same manner as the tissue support interface and the second elastomer component is inserted into each of the clamping arms.

[0072] Those skilled in the art will be able to devise various variations and modifications without departing from the present disclosure. Accordingly, the present disclosure is intended to encompass all such variations, modifications, and variations. Moreover, while several exemplary configurations of the present disclosure have been shown in the drawings and / or discussed herein, the present disclosure is not limited thereto but is intended to have the broadest scope as permitted by the art, and the specification is to be interpreted accordingly. Accordingly, the foregoing description should not be considered limiting, but merely illustrative of particular configurations. Moreover, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods, and techniques that differ only insubstantially from those described above and / or in the appended claims are also intended to fall within the scope of the present disclosure.

[0073] The drawings are presented merely to demonstrate some examples of the present disclosure. The depicted drawings are merely exemplary and non-limiting. In the drawings, for illustrative purposes, the size of some elements may be exaggerated and not drawn to scale. Furthermore, elements shown in the drawings with the same number may be identical or similar elements, depending on the context.

[0074] Where the term "comprising" is used in the specification and claims, it does not exclude other elements or steps. For example, where an indefinite or definite article such as "a," "an," or "the" is used when referring to a singular noun, this includes a plural of that noun unless specifically stated otherwise. Thus, the term "comprising" should not be construed as being limited to the items listed thereafter, and does not exclude other elements or steps, and therefore the scope of the expression "a device comprising items A and B" should not be limited to a device consisting of only components A and B.

[0075] Furthermore, whether used in the specification or in the claims, terms such as "first," "second," "third," etc. are provided to distinguish between similar elements and not necessarily to describe an order or chronology. It is to be understood that terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise) and that the exemplary configurations of the disclosure described herein are capable of operating in orders and / or arrangements other than those described or illustrated herein.

Claims

1. In the cannula for connecting the vessels of the tissue to be perfused to the perfusion loop: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold at least one vessel of the tissue to be perfused in compression about the cannula strut; A cannula comprising:

2. 2. The cannula of claim 1, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage each other around the vessel of the tissue to be perfused and the cannula post.

3. a first elastomeric component positioned about the cannula post; a second elastomeric component positioned within each of the clamping arms; The cannula of claim 2 further comprising:

4. the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms; The cannula of claim 3.

5. The cannula of claim 3 , wherein the first elastomeric component is inserted onto the cannula post and the second elastomeric component is inserted into each of the clamping arms.

6. 4. The cannula of claim 3, wherein the clamping arms compress the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the first elastomeric component.

7. 4. The cannula of claim 3, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms.

8. the clamping arms compressing the flared end of the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the flared end of the first elastomeric component; The cannula of claim 7.

9. a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising The cannula of claim 2, wherein in the clamping position, the clamping members engage the clamping detents to retain the clamping arms.

10. The cannula of claim 9, wherein pressure on the clamping arms disengages them from the clamping detents.

11. opposing shoulders extending from an outer surface of the cannula body and including a pivot slot, a front locking detent, and a rear locking detent; The cannula of claim 1 , further comprising:

12. 12. The cannula of claim 11, further comprising a pivot bar and a locking bar at a rearward end of each of the clamping arms, the pivot bar pivotally received within the pivot slot, the locking bar received and retained within the rear locking detent when the clamping arms are in the open position, and the locking bar received and retained within the front locking detent when the clamping arms are in the clamping position.

13. 13. The cannula of claim 12, wherein in the open position, the two clamping arms are pivoted rearward relative to the cannula body, and in the clamping position, the clamping arms are pivoted forward relative to the cannula body to engage each other around the vessel of the tissue to be perfused and the cannula post.

14. a first elastomeric component positioned about the cannula post; a second elastomeric component positioned within each of the clamping arms; The cannula of claim 11 further comprising:

15. the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms; 15. The cannula of claim 14.

16. The cannula of claim 14, wherein the first elastomeric component is inserted onto the cannula post and the second elastomeric component is inserted into each of the clamping arms.

17. 15. The cannula of claim 14, wherein the clamping arms compress the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the first elastomeric component.

18. 15. The cannula of claim 14, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms.

19. 19. The cannula of claim 18, wherein the clamping arms compress the flared end of the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the flared end of the first elastomeric component.

20. a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising In the clamping position, the clamping members engage the clamping detents to retain the clamping arms. The cannula of claim 12.

21. 21. The cannula of claim 20, wherein pressure on the clamping arms disengages them from the clamping detents.

22. 21. The cannula of claim 20, wherein in the clamping position, the clamping members are slid rearward to engage the locking bar with the front locking detent.

23. 19. The cannula of claim 18, wherein in the clamping position, the clamping members are slid rearward to engage the locking bar with the front locking detent.

24. 24. The cannula of claim 23, wherein the clamping arms compress the flared end of the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the flared end of the first elastomeric component.

25. The cannula of claim 1 , wherein the tubing interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

26. The cannula of claim 12, wherein the tubing interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

27. A cannula for connecting at least one vessel of the tissue to be perfused to a perfusion loop, comprising: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a tissue interface support at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in compression together with the tissue interface support; A cannula comprising:

28. 28. The cannula of claim 27, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage each other around the vessel and the tissue interface support of the tissue to be perfused.

29. The cannula of claim 27, wherein the tissue interface support is substantially circular.

30. 28. The cannula of claim 27, wherein the tissue interface support is elongated to accommodate two or more vessels of the tissue to be perfused.

31. an elastomeric component positioned within each of the clamping arms; 28. The cannula of claim 27, further comprising:

32. the elastomeric component being overmolded into each of the clamping arms; 32. The cannula of claim 31.

33. 32. The cannula of claim 31, wherein the elastomeric component is inserted within each of the clamping arms.

34. at least one cannula strut with a lumen extending therethrough housed adjacent the tissue support interface; 32. The cannula of claim 31, further comprising:

35. 35. The cannula of claim 34, wherein the clamping arms compress the elastomeric component against an outer surface of the vessel which itself compresses the inner surface of the vessel against the cannula posts.

36. 35. The cannula of claim 34, wherein the cannula struts have an elastomeric component about their outer surfaces.

37. a clamp support platform received around said cannula body and including a pivot bar supported at an opposite end thereof in a shoulder; further comprising 28. The cannula of claim 27, wherein the first and second clamping arms have pivot ends rotatably received about the pivot bar.

38. 38. The cannula of claim 37, wherein the clamp support platform is linearly movable along a linear axis of the cannula body.

39. a clamping dial rotatable about said cannula body, said rotation causing linear displacement of the clamping dial along said cannula body; 38. The cannula of claim 37, further comprising:

40. 40. The cannula of claim 39, wherein linear displacement of the clamping dial similarly causes linear displacement of the clamp support platform and the clamping arms attached thereto, thereby retracting the clamping arms into contact with the tissue support platform.

41. In the cannula for connecting the vessels of the tissue to be perfused to the perfusion loop: a cannula body with a lumen extending therethrough; a tubing interface at a first end of the cannula body for connection to the perfusion loop; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessel of the tissue to be perfused in compression about the cannula strut; A cannula comprising:

42. 42. The cannula of claim 41, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage each other around the vessel of the tissue to be perfused and the cannula post.

43. a first elastomeric component positioned about the cannula post; a second elastomeric component positioned within each of the clamping arms; 42. The cannula of claim 41, further comprising:

44. the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms; 44. The cannula of claim 43.

45. 44. The cannula of claim 43, wherein the first elastomeric component is inserted onto the cannula post and the second elastomeric component is inserted into each of the clamping arms.

46. 44. The cannula of claim 43, wherein the clamping arms compress the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the first elastomeric component.

47. 44. The cannula of claim 43, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms.

48. the clamping arms compressing the flared end of the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the flared end of the first elastomeric component; 48. The cannula of claim 47.

49. a clamping detent on a first of the clamping arms; and a clamping member on a second of said clamping arms; further comprising 42. The cannula of claim 41, wherein in the clamping position, the clamping members engage the clamping detents to retain the clamping arms.

50. 50. The cannula of claim 49, wherein pressure on the clamping arms disengages them from the clamping detents.

51. opposing shoulders extending from an outer surface of the cannula body and including a pivot slot, a front locking detent, and a rear locking detent; 42. The cannula of claim 41, further comprising:

52. 42. The cannula of claim 41, wherein the tubing interface is an interface selected from the group consisting of a T-connector, a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

53. In the cannula for connecting the vessels of the tissue to be perfused to the perfusion loop: a cannula body with a lumen extending therethrough; Primary cannula interface; secondary cannula interface; perfusion loop interface; a T-joint having a T-joint interface at a first end of the cannula body; a cannula post at a second end of the cannula body configured to receive the vessel of the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessel of the tissue to be perfused in compression about the cannula strut; A cannula comprising:

54. 54. The cannula of claim 53, wherein the primary cannula interface is configured for connection with the cannula.

55. 54. The cannula of claim 53, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula.

56. 54. The cannula of claim 53, wherein the perfusion loop interface is configured for connection with the perfusion loop.

57. 54. The cannula of claim 53, wherein the T-joint interface is configured for connection with a T-joint.

58. 54. The cannula of claim 53, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage each other around the vessel of the tissue to be perfused and the cannula post.

59. a first elastomeric component positioned about the cannula post; a second elastomeric component positioned within each of the clamping arms; 59. The cannula of claim 58, further comprising:

60. the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is overmolded into each of the clamping arms; 60. The cannula of claim 59.

61. 60. The cannula of claim 59, wherein the first elastomeric component is inserted onto the cannula post and the second elastomeric component is inserted into each of the clamping arms.

62. 60. The cannula of claim 59, wherein the clamping arms compress the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the first elastomeric component.

63. 60. The cannula of claim 59, wherein the cannula post has a flared base, the first elastomeric component has a flared end corresponding to the flared base of the cannula post, the clamping arms have a flared base, and the second elastomeric component has a flared end corresponding to the flared base of the clamping arms.

64. the clamping arms compressing the flared end of the second elastomeric component against an outer surface of the vessel which itself compresses an inner surface of the vessel against the flared end of the first elastomeric component; 64. The cannula of claim 63.

65. 65. The cannula of claim 64, wherein the clamping arms press the second elastomeric component against the outer surface of the vessel which itself presses the inner surface of the vessel against the first elastomeric component, the elastomeric component having a flared end corresponding to the flared base of the clamping arms.

66. clamping detents on the first set of clamping arms; a collar post on said first set of clamping arms; a clamping member on the second set of clamping arms; and release tabs on the second set of clamping arms; further comprising 64. The cannula of claim 63, wherein in the clamping position, the clamping members engage the clamping detents to retain the clamping arms.

67. 67. The cannula of claim 66, wherein pressure on the release tab disengages the clamping members from the clamping detents.

68. 67. The cannula of claim 66, wherein the collar post has a collar post detent configured to couple to a tray.

69. a set of shoulders extending from an outer surface of said cannula body, each shoulder within said shoulder set having a pivot slot, a detent guide and a cannula body pocket; 54. The cannula of claim 53, further comprising:

70. a set of pivot supports at the rearward end of each of said clamping arms, said pivot supports having a pivot bar pivotally received within said pivot slot; 70. The cannula of claim 69, further comprising:

71. at least one collar detent positioned inwardly of the pivot support, the collar detent being received by the detent guide and retained within the cannula body pocket when the clamping arms are in the clamping position; 71. The cannula of claim 70, further comprising:

72. 72. The cannula of claim 71, wherein in the open position the two clamping arms are pivoted rearward relative to the cannula body, and in the clamping position the clamping arms are pivoted forward relative to the cannula body to engage each other around the vessel of the tissue to be perfused and the cannula post.

73. 54. The cannula of claim 53, wherein the perfusion loop interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

74. 54. The cannula of claim 53, wherein the primary cannula interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

75. 54. The cannula of claim 53, wherein the secondary cannula interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

76. 54. The cannula of claim 53, wherein the T-junction interface is an interface selected from the group consisting of a luer connector, a barbed connector, a locking connector, and a spin-lock connector.

77. In the cannula for connecting the vessels of the tissue to be perfused to the perfusion loop: a cannula body with a lumen extending therethrough; Primary cannula interface; secondary cannula interface; perfusion loop interface; a T-joint having a T-joint interface at a first end of the cannula body; a tissue support interface configured to receive a distal end of the vessel in the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in compression while in contact with the tissue support interface; A cannula comprising:

78. 78. The cannula of claim 77, wherein the tissue support interface is substantially circular.

79. 78. The cannula of claim 77, wherein the tissue support interface is elongated.

80. 78. The cannula of claim 77, wherein the primary cannula interface is configured for connection with the cannula.

81. 78. The cannula of claim 77, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula.

82. 78. The cannula of claim 77, wherein the perfusion loop interface is configured for connection with the perfusion loop.

83. 78. The cannula of claim 77, wherein the T-joint interface is configured for connection with a T-joint.

84. 78. The cannula of claim 77, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body, and a clamping position in which the clamping arms are pivoted forward relative to the cannula body and engage with each other around the vessel and tissue support interface of the tissue to be perfused.

85. a first elastomeric component positioned similarly to the tissue support interface; a second elastomeric component positioned within each of the clamping arms; 85. The cannula of claim 84, further comprising:

86. 86. The cannula of claim 85, wherein the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is similarly overmolded onto the tissue support interface.

87. 86. The cannula of claim 85, wherein the first elastomeric component is inserted in the same manner as the tissue support interface and the second elastomeric component is inserted into each of the clamping arms.

88. In the cannula for connecting the vessels of the tissue to be perfused to the perfusion loop: a cannula body with a lumen extending therethrough; a perfusion loop interface at a first end of the cannula body; a tissue support interface at a second end of the cannula body configured to receive a distal end of the vessel in the tissue to be perfused; two clamping arms pivotally connected to the cannula body operable to hold the vessels of the tissue to be perfused in compression while in contact with the tissue support interface; A cannula comprising:

89. 89. The cannula of claim 88, wherein the tissue support interface is substantially circular.

90. 89. The cannula of claim 88, wherein the tissue support interface is elongated.

91. The perfusion loop interface further comprises: a T-joint having a primary cannula interface and a secondary cannula interface; 89. The cannula of claim 88, comprising:

92. 92. The cannula of claim 91, wherein the primary cannula interface is configured for connection with the cannula.

93. 92. The cannula of claim 91, wherein the secondary cannula interface is configured to be capped or coupled with a secondary cannula.

94. 89. The cannula of claim 88, wherein the two clamping arms have an open position in which the clamping arms are pivoted rearward relative to the cannula body and a clamping position in which the clamping arms are pivoted forward relative to the cannula body.

95. a pinch lock adjacent the second end of the cannula body; and locking tabs at the distal ends of the two clamping arms; wherein the clamping lock engages the locking tab to retain the clamping arms in the clamping position.

95. The cannula of claim 94.

96. 96. The cannula of claim 95, wherein the clamping lock has two deflectable arms with detents thereon that are deflected by the locking tabs as the clamping arms are rotated from the open position to the closed position, the detents engaging the locking tabs to retain the clamping arms in the clamping position.

97. a first elastomeric component positioned similarly to the tissue support interface; a second elastomeric component positioned within each of the clamping arms; 89. The cannula of claim 88, further comprising:

98. 98. The cannula of claim 97, wherein the first elastomeric component is overmolded onto the cannula post and the second elastomeric component is similarly overmolded onto the tissue support interface.

99. 98. The cannula of claim 97, wherein the first elastomeric component is inserted similarly to the tissue support interface and the second elastomeric component is inserted within each of the clamping arms.

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