Abstract: Devices and methods for monitoring the temperature of tissue at various locations in a treatment volume during fluid enhanced ablation therapy are provided. In one embodiment, an ablation device is provided having an elongate body, at least one ablation element, and at least one temperature sensor. The elongate body includes a proximal and distal end, an inner lumen, and at least one outlet port to allow fluid to be delivered to tissue surrounding the elongate body. The at least one ablation element is configured to heat tissue surrounding the at least one ablation element. The at least one temperature sensor can be positioned a distance away from the at least one ablation element and can be effective to output a measured temperature of tissue spaced a distance apart from the at least one ablation element such that the measured temperature indicates whether tissue is being heating to a therapeutic level.

Abstract: There is disclosed a heating device which is adapted to be used to warm medical solutions contained within medical devices such as an intravenous bag, intravenous tube or respiratory circuit. The heating device includes an elongated flexible material tube having an interior medical solution channel and a pair of heat channels. The heat channels are filled or coated with a flexible, electrically conductive substance, which forms an electrical resistor. The conductive substance is electrically coupled to an electric power source controller. Electric current passing through the conductive substance creates heat which is transferred from the heat channels to the medical solution contained within the interior medical solution channel.

Abstract: A cooling attachment module for use with a vibration therapy device that includes a housing and/or heat sink member that includes inner and outer walls and defines a central opening axially therethrough. A cooling recess is defined in an upper surface and a connection recess is defined in a lower surface of the heat sink member. A cover member is secured over the cooling recess. A controllable temperature element is positioned on an upper surface of the heat sink member. A spreader member is positioned on an upper surface of the controllable temperature element. An upper surface of the spreader member is positioned above an upper surface of the cover member to contact a user's body part. The controllable temperature element is configured to transfer thermal energy to a lower surface of the spreader member. A base portion that includes an electrical connector is secured under the electrical recess.

Abstract: An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid. The apparatus includes an inflatable perfusion balloon including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon including a plurality of cells in a single cross section and a covering for at least partially covering the cells. A valve associated with the balloon controls the fluid flow within the passage, the valve being arranged external to the passage. The valve may form a tubular extension of the covering, or may be separate from the covering, and may comprise flaps. A spiral covering may also form the valve.

Abstract: A notification control device for controlling notification based on subject information is disclosed. The subject information including temperature image data, which indicates temperature of a subject captured within a predetermined capturing range, is received. A predetermined destination of notification information, which represents a state of the subject based on the subject information, is notified. A process of notifying the notification information to the predetermined destination is stopped depending on whether or not the subject information includes predetermined identification information.

Abstract: A method for treating vascular diseases is provided. The method includes fabricating a sterile ice slurry including water and ice particles, cooling the sterile ice slurry to a predetermined temperature, and injecting the sterile ice slurry into a desired tissue region. The desired tissue region includes perivascular adipose tissue.

Abstract: A multi-stage system for warming blood that enables safe and rapid blood transfusions in the field. The first stage of the system is a rapid blood warming device that heats blood quickly from cold storage to body temperature. This stage may use a high-energy power source, such as AC power, that is available in a facility such as a hospital. The second stage is a portable heated blood transport device into which heated blood bags are placed for transportation to a patient. This device keeps the blood bags warm using battery power. Because blood bags are pre-heated with the rapid warming device, the transport device can be lightweight and portable. An optional third stage is a transfusion temperature regulating device that boosts the final temperature of blood just before it enters the patient. All three devices may have sensors and controllers that maintain blood temperature within desired ranges.

Abstract: An organ can be cooled to minimize ischemic tissue damage from a vascular occlusion by a thrombus or dissection. A catheter including a thermal member can be used to introduce cold fluid downstream from an arterial occlusion to cool tissue affected by the occlusion. This is particularly useful to minimize neurologic damage from a thrombotic stroke.

Abstract: An end effector structure for tissue ablation powered by microwave energy source and end effector including a microwave antenna surrounded by a segments from microwave absorbing materials. Microwave absorbing material is a material, transparent to microwave energy impregnated with microwave absorbing particles, and has differing microwave transmission and/or absorption characteristics at different locations along the microwave antenna to apply to the desired bi-tissue, a selective amount of microwave and/or heat energy. Microwave transparent material can be ceramic, silicone, fluorosilicone, fluorocarbon, thermoplastic rubber, ethyline propylene diene monomer, urethane etc. Microwave absorbing particles can be from nickel (Ni), copper (Cu), Aluminum (Al), Ag/Cu; Ag/Al; Ag/Ni; Ag/Glass, nickel-plated graphite, silver-plated aluminum, silver-plated copper, silver-plated nickel, silver-plated glass and pure silver etc.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to methods including selectively neuromodulating afferent or efferent renal nerves. One or more measurable physiological parameters corresponding to systemic sympathetic overactivity or hyperactivity in the patient can thereby be reduced. Selectively neuromodulating afferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a renal pelvis. This can include, for example, neuromodulating via fluid within the renal pelvis. Selectively neuromodulating efferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a portion of a renal artery or a renal branch artery proximate a renal parenchyma. This can include, for example, neuromodulating via a therapeutic element within the portion of the renal artery or the renal branch artery.

Abstract: An implantable drug delivery device and method for delivering a drug to a living body. The device includes a housing having at least one opening, a reservoir within the housing adapted to contain a drug, a temporary seal closing the opening of the housing, and a heating element in thermal contact with the temporary seal. The heating element is adapted to generate heat in response to a magnetic field to melt the temporary seal and release a drug within the reservoir through the opening of the housing.

Abstract: An assembly for the thermal treatment and moisture treatment of physical conditions, the assembly including, a first thermal pack having a body, the body having a first face and a second face, the first face having a first protrusion. The assembly further includes a sleeve operatively arranged to receive the first thermal pack, the sleeve having a first surface. The assembly also includes a medicament pad arranged to be removably secured to the first surface of the sleeve.

Abstract: An intravascular catheter system for cardiac mapping is disclosed which includes a housing having opposed proximal and distal portions, an elongated catheter shaft operatively associated with the distal portion of the housing, an elongated electrical conduit operatively associated with the proximal portion of the housing and an elongated irrigation conduit operatively associated with the proximal portion of the housing, wherein an irrigated basket assembly is operatively associated with a distal end portion of the catheter shaft and it includes a plurality of circumferentially arranged electrically insulated tubular splines each having a plurality of longitudinally spaced apart mapping electrodes thereon.

Abstract: Disclosed is an auto injector and a method for administering a medicament. The auto injector comprising: a housing; a cartridge receiver; a drive module coupled to move a plunger rod configured to move a first stopper; a temperature sensor configured to provide a temperature signal indicative of the temperature of the medicament in the cartridge; a processing unit configured to: receive the temperature signal; control the drive module to move the plunger rod from a first plunger rod position to a mix plunger rod position wherein the movement from the first plunger rod position to the mix plunger rod position is based on the temperature signal.

Abstract: A catheter-based medical device including controlled refrigerant dispersion is disclosed. The device includes a fluid injection tube that carries refrigerant from a coolant supply to the distal portion of the device. A fluid dispersion unit is disposed on the distal end of the fluid tube to control the angle of distribution for refrigerant that is expelled from the fluid injection tube. Controlling the angle of distribution for the refrigerant facilitates dispersion of the fluid in a predetermined spray pattern. The disclosure further relates to cryoablation treatment systems incorporating such a catheter, and to cryoablation treatment methods for tissue treatment to address various conditions suitably treatable with cryoablation.

Abstract: Guided relay infusion systems and methods are provided. A guided relay infusion system may be a portion of an infusion pump that can simultaneously deliver a medical fluid from two syringes. When a first one of the syringes is running out of the medical fluid and a second one of the syringes is more full of the medical fluid than the first one of the syringes, guided relay messages are provided for a relay handoff from the first one of the syringes to the second one of the syringes that ensures a smooth continuous delivery of more of the medical fluid than the first one of the syringes holds.

Abstract: A fluid infusion system includes an air pump connected to an accumulator tank to produce pressurized air that is stored in the accumulator tank. The system can include one or more fluid bag chambers wherein each fluid bag chamber includes an inflatable bladder positioned inside the fluid bag chamber to apply pressure on the fluid bag supported inside the chamber. The fluid bag can be connected by a tube set to deliver fluid from the fluid bag to a surgical tool at a surgical site. The fluid can, for example, be irrigation fluid or distention fluid. The system can include a controller connected to the pump to control the pump to produce the pressurized air and an adjustable pressure regulator can be connected between the accumulator tank and the inflatable bladder to control the pressure of air delivered to the inflatable bladder and the pressure that the fluid is delivered to the surgical tool.

Abstract: This application relates to a hand-held cooling device for supplying a cryogen to a target region for cryotherapy. The device can include a cryogen transfer unit configured to receive a first cryogen from an external cryogen reservoir, the first cryogen including i) a first amount of a liquid phase cryogen and ii) at least one of a first solid phase cryogen and a first gas phase cryogen. The device can also include a nozzle configured to spray a first modified cryogen to the target region. The device can further include a cryogen liquefier disposed between the cryogen container and the nozzle and configured to cool the first cryogen received from the cryogen transfer unit and output the first modified cryogen to the nozzle, the first modified cryogen including at least a second amount of the liquid phase cryogen more than the first amount of the liquid phase cryogen.

Abstract: The present disclosure relates to a thermal ablation probe device that integrates deployable sensors with a freezing probe or heating probe for use in ablating tissues. The ablation probe includes a longitudinal body including a thermal ablation energy source which may be, e.g., a cryosource or a heat source. The longitudinal body has a proximal end and a distal end terminating at a probe tip; and at least one deployable assembly disposed within the longitudinal body. The deployable assembly includes a flexible and substantially rigid deployment member, and at least one sensor affixed to a distal end of the deployment member. The ablation probe further includes a control mechanism for controlling deployment and retraction of the deployable assembly.

Abstract: A device and a method for mixing a fluid in a specimen bag is provided herein. In one embodiment, the device includes a mechanism for creating a first vortex and a second vortex. The first vortex is on a first side of a bag containing the fluid, and the second vortex is on a second side of the bag. The mechanism includes a first inflatable airbag and a second inflatable airbag. The first inflatable airbag is configured to create the first vortex when inflated and the second inflatable airbag is deflated. The second inflatable airbag is configured to create the second vortex when inflated and the first inflatable airbag is deflated.

Abstract: A catheter pump assembly is provided that includes an elongate polymeric catheter body, a cannula, and a tubular interface. The elongate polymeric catheter body has a proximal end and a distal end. The cannula has an expandable portion disposed distally of the elongate polymeric catheter body. The cannula can also have another tubular portion that is proximal to the distal portion. The tubular interface has an outer surface configured to be joined to the tubular portion of the cannula and an inner surface. The inner surface is disposed over the distal end of the elongate polymeric catheter body. The tubular interface has a plurality of transverse channels extending outward from the inner surface of the tubular interface. An outer surface of the elongate polymeric catheter body projects into the transverse channels to mechanically integrate the elongate polymeric catheter body with the tubular interface.

Abstract: A treatment system delivers a breathing gas and frozen ice or other particles (FSP) to a bronchus of a lung of a patient in order to induce hypothermia. The breathing gas and the FSP are usually delivered through separate lumens. Clogging of an FSP lumen can be inhibited by heating and/or cooling of the lumen. The temperature of exhaled gases or a body temperature may be measured, and a controller can adjust the duration or rate at which the ice particles are delivered in order to control the patient's core temperature based on the measured temperature.

Abstract: Provided herein are methods, systems, and devices for increasing heat shock protein expression and treating conditions for which increased heat shock protein expression is expected to be beneficial using thermal ablation.

Abstract: A system for heating a medical fluid has at least one first fluid container for storing the fluid, a fluid injector having at least one second fluid container for receiving the fluid from the at least one first fluid container through a fluid path set, at least one heating element positioned in-line with the fluid path set between the at least one first fluid container and the at least one second fluid container of the fluid injector for heating the fluid to a pre-determined temperature as the fluid flows through at least one fluid path element, and a controller for controlling an output of the at least one heating element based on at least one of a property of the at least one heating element and a property of the fluid flowing through the at least one fluid path element.

Abstract: A surgical instrument includes a reusable component and a disposable component selectively separable from and engagable with the reusable component. The disposable component includes an end effector and a mechanical actuator operable to induce mechanical movement of the end effector. The reusable component is configured for providing electrosurgical energy to the disposable component when engaged with the disposable component. A physical mating feature is configured to maintain engagement between the reusable and disposable components when the reusable and disposable components are engaged, and an electrical mating feature is configured to transmit electrical energy between the disposable and reusable components when the disposable and reusable components are engaged. All mechanical motion resulting from operation of the mechanical actuator may be contained within the disposable component.

Abstract: There is provided feeding tubes including an electromagnetic sensor including a sensor body comprising a core positioned at a distal end of the sensor lumen, and a wire extending along the length of the feeding tube, wherein an RF induced heating of the feeding tube in an MRI environment is below 5 degrees.

Abstract: There is provided a device for insertion into a body cavity, the device includes an insertion member configured to be inserted into the body cavity, an expandable member coupled to the insertion member, the expandable member capable of being expanded to apply pressure onto tissue within the body cavity, a first member configured for storing a first endothermic reactant therein, and a second member configured for storing a second endothermic reactant therein. In particular, the first and second members are configured to, in a state of the device (e.g., compressed state), allow the first and second endothermic reactants to cooperate to effect an endothermic reaction to generate an endothermic product. Furthermore, the expandable member is configured to receive at least one of the first or second endothermic reactant and the endothermic product through a channel within the insertion member. There is also provided a method of fabricating a device for inserting into a body cavity.

Abstract: The invention is a wearable breast pump system including a housing shaped at least in part to fit inside a bra and a piezo air-pump. The piezo air-pump is fitted in the housing and forms part of a closed loop system that drives a separate, deformable diaphragm to generate negative air pressure. The diaphragm is removably mounted on a breast shield.

Abstract: A method for treatment of a brain and/or spinal cord includes inserting a flexible catheter into a cerebrospinal fluid space, the flexible catheter including two lumens adapted to allow a fluid to circulate therein in a closed loop within the flexible catheter and the flexible catheter being adapted to be connected to a device for cooling and circulating the fluid. The cerebrospinal fluid in the cerebrospinal fluid space is cooled with the flexible catheter to enable selective central nervous system cooling. The functional status of the brain and/or spinal cord is monitored, and the treatment of the brain and/or spinal cord is modified to adjust for any change in the functional status of the brain and/or spinal cord.

Abstract: A cold and heat exchange system for a cardiac surgical operation with cardiac arrest, comprising: an ice water tank (15), a primary circulation water tank (11), and a secondary circulation water tank (16). Side walls of the primary circulation water tank (11) and the secondary circulation water tank (16) are each provided with an overflow orifice which is connected to the ice water tank (15) through a circulation pipe (14). A first roller pump (12) is mounted on a first hose (13). A second roller pump (18) is mounted on a second hose (17). The primary circulation water tank (11) is mounted on a first loop (5) and a second loop (6). The secondary circulation water tank (16) is mounted on a third loop (1).

Abstract: Discloses herein are ablative catheters and methods of use. The catheters can include a cooling chamber for circulating cooling fluid within the catheter tip to reduce hot spots within the catheter tip and/or to reduce the formation of coagulum. A proximal cooling chamber can be positioned proximally to a thermal mass for cooling a proximal portion of the catheter. In addition, or alternatively, a distal cooling chamber can be positioned for cooling a distal portion of the catheter tip. The cooling fluid can flow the ablative catheter in an open, closed, or open and closed loop.

Abstract: A surgical instrument for ablating tissue includes a handle portion and a shaft assembly extending distally from the handle portion. The shaft assembly includes an outer shaft, a coaxial cable extending through the outer shaft, and an electrode coupled to a distal portion of the outer shaft. The coaxial cable has a distal portion that forms a microwave antenna configured to transmit microwave energy radially outward and through the outer shaft. The electrode is configured to transmit radiofrequency energy. An actuation of the handle portion activates the transmission of the microwave energy from the microwave antenna and/or the transmission of the radiofrequency energy from the at least one electrode.

Abstract: The protecting body for a flexible pouch is specially designed to contain a biopharmaceutical fluid. It includes two substantially planar plates which respectively form a lower surface and an upper surface and which are fixed to each other. The two plates are able to sandwich the flexible pouch for constraining the flexible pouch such that the protecting body is substantially planar, and includes, on a peripheral side, at least one opening able to receive at least one port of the flexible pouch.

Abstract: Systems and methods that use thermal energy transfer devices to reduce thermal energy within environments are disclosed. According to an aspect, a method includes using a cool sink to transfer thermal energy from an environment. The method also includes using a thermal energy transfer device to transfer the thermal energy to liquid within a conduit. Further, the method includes transporting the liquid containing the transferred thermal energy away from the environment such that the thermal energy within the environment is reduced.

Abstract: This invention relates to a novel surgical device scalable to small dimensions for thermally-mediated treatments or thermoplasties of targeted tissue volumes. An exemplary embodiment is adapted for fusing, sealing or welding tissue. The instruments and techniques utilize a thermal energy delivery means, for example an electrical energy source, to instantly elevate the temperature of a biocompatible fluid media within an electrically insulated instrument portion. The altered media which may then be a gas is characterized by a (i) a high heat content, and (ii) a high exit velocity from the working end, both of which characteristics are controlled to hydrate tissue and at the same time denature proteins to fuse, seal, weld or cause any other thermally-mediated treatment of an engaged tissue volume—while causing limited collateral thermal damage and while totally eliminating electrical current flow the engaged tissue volume.

Abstract: An illuminator for photodynamically diagnosing or treating a surface includes a plurality of panels. The illuminator further includes a plurality of light sources, each mounted to one of the plurality of panels. The plurality of light sources are configured to irradiate the surface with substantially uniform intensity visible light. The illuminator also includes a heat source configured to emit heat to a patient. The heat increases the generation of a photoactivatable agent and thus shortens the time needed to complete photodynamic therapy.

Abstract: A device, kit, and method for producing medically-deliverable intravenous solution may include supplying a liquid to a housing, pumping the liquid through the housing while purifying the liquid, metering concentrated intravenous solution into the liquid to create a medically-deliverable intravenous solution, and dispensing the medically-deliverable intravenous solution.

Abstract: Devices and methods for monitoring the temperature of tissue at various locations in a treatment volume during fluid enhanced ablation therapy are provided. In one embodiment, an ablation device is provided having an elongate body, at least one ablation element, and at least one temperature sensor. The elongate body includes a proximal and distal end, an inner lumen, and at least one outlet port to allow fluid to be delivered to tissue surrounding the elongate body. The at least one ablation element is configured to heat tissue surrounding the at least one ablation element. The at least one temperature sensor can be positioned a distance away from the at least one ablation element and can be effective to output a measured temperature of tissue spaced a distance apart from the at least one ablation element such that the measured temperature indicates whether tissue is being heating to a therapeutic level.

Abstract: Presented herein is an infusate heating system with a vacuum release valve that obviates a system halt failure due to inaccurate detection of fluid level in an infusate reservoir.

Abstract: A breastpump unit for expressing human breastmilk has a breastshield for placing on a human mother's breast, a vacuum pump for generating an underpressure, and a suction line for connecting the breastshield to the vacuum pump and for transferring to the breastshield the underpressure generated by the vacuum pump. The breastpump unit also has a pressure sensor. In addition, a measuring line is present, wherein the measuring line extends from the breastshield to the pressure sensor.

Abstract: The present invention provides for implant device delivery apparatuses and related methods of use. The delivery systems of the present invention incorporate a stretch resistant tube that advantageously makes the implant device, such as an embolic coil, stretch resistant while a delivery system is being used to position the implant device at a desired target site.

Abstract: A device for treating esophageal target tissue comprises a catheter, a balloon and a refrigerant delivery device. The catheter has a distal portion and a refrigerant delivery lumen. The balloon is mounted to and the refrigerant delivery device is coupled to the distal portion. The refrigerant delivery device comprises a chamber with the refrigerant delivery lumen opening into the chamber, a refrigerant delivery opening fluidly coupled to the balloon interior, and a distribution passageway fluidly coupling the chamber and the refrigerant delivery opening. A refrigerant is deliverable through the refrigerant delivery lumen, into the chamber, through the distribution passageway, through the refrigerant delivery opening and into the balloon interior so to place the balloon into an expanded, cooled state so that the balloon can press against and cool esophageal target tissue. The medical device may include means for sensing a leak in the balloon.

Abstract: Devices and methods are discussed directed to the use of a low profile laser ablation catheter for use in laser ablation removal of arterial plaque blockages to restore blood flow in the treatment of arteriovenous fistulas. Also discussed are devices and methods directed to packaging, long term storage and sterilization of liquid core ablation catheters.

Abstract: An apparatus, probe and method for a cryogenic system are described. According to certain embodiments of the invention there is provided an apparatus for cryosurgery comprising: an exhaust line configured to receive cryogen from a probe; and a vacuum source configured to be in fluid communication with the exhaust line.

Abstract: The present invention relates to systems and devices for delivering energy to tissue for a wide variety of applications, including medical procedures (e.g., tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc.). In particular, the present invention relates to systems and devices for the delivery of energy with heat transfer ability. In some embodiments, the systems and devices also have variable characteristic impedance as a result of the use of heat transfer materials. In certain embodiments, methods are provided for treating a tissue region (e.g., a tumor) through application of energy with the systems and devices of the present invention.

Abstract: Methods for treating a patient using therapeutic renal neuromodulation and associated devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to methods including selectively neuromodulating afferent or efferent renal nerves. One or more measurable physiological parameters corresponding to systemic sympathetic overactivity or hyperactivity in the patient can thereby be reduced. Selectively neuromodulating afferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a renal pelvis. This can include, for example, neuromodulating via fluid within the renal pelvis. Selectively neuromodulating efferent renal nerves can include inhibiting sympathetic neural activity in nerves proximate a portion of a renal artery or a renal branch artery proximate a renal parenchyma. This can include, for example, neuromodulating via a therapeutic element within the portion of the renal artery or the renal branch artery.

Abstract: A cryotreatment catheter for treating tissue. The catheter may include an outer elongate body, a balloon treatment element coupled to the distal portion of the elongate body with a plurality of balloon lobes radially arranged around the outer elongate body, an inner elongate body rotatably movable within the lumen of the outer elongate body, and a fluid delivery lumen located within the lumen of the outer elongate body and at least partially within the lumen of the inner elongate body. The fluid delivery lumen may be branched at a distal portion into a plurality of linear segments, each linear segment being in fluid communication with one of the plurality of balloon lobes. Each of the balloon lobes may be inflated independently of each other by the linear segments of the fluid delivery lumen.

Abstract: An ultrasonic surgical tool has probe body with an operative surface or edge contactable with organic tissues for performing a surgical operation on the tissues. A shank of the probe body is provided with a connector for operatively attaching the tool to a source of ultrasonic mechanical vibrational energy. The shank and a portion of the probe body are formed with a channel for fluid delivery to the probe body. At least a portion of the probe body located between the channel and the operative surface or edge has a microporous or sintered structure enabling fluid penetration to the operative surface or edge from the channel.

Abstract: Ablation systems of the present disclosure facilitate the safe formation of wide and deep lesions. For example, ablation systems of the present disclosure can allow for the flow of irrigation fluid and blood through an expandable ablation electrode, resulting in efficient and effective cooling of the ablation electrode as the ablation electrode delivers energy at a treatment site of the patient. Additionally, or alternatively, ablation systems of the present disclosure can include a deformable ablation electrode and a plurality of sensors that, in cooperation, sense the deformation of the ablation electrode, to provide a robust indication of the extent and direction of contact between the ablation electrode and tissue at a treatment site.

Abstract: Methods for (a) preventing hypoxic damage to a potentially transplantable organ or tissue prior to explanation of that organ or tissue from the body of a mammalian transplant donor and (b) preventing rejection of a transplanted organ or tissue in a human or veterinary transplant recipient. The methods comprise placing a heat exchange apparatus in the vasculature of the donor or recipient and using that heat exchange apparatus to cool at least a portion of the body of the donor or recipient to a temperature below normothermia (e.g. below normothermia and sometimes between about 30° C. and about 36° C.).