Fluid delivery lines and connection systems for targeted temperature management systems - Patents.com
Patent Information
- Application Number
- JP2023568116
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-05-06
- Filing Date
- 2022-05-03
- Publication Date
- 2025-04-11
AI Technical Summary
Existing fluid delivery systems for targeted temperature management (TTM) systems face challenges such as fluid leakage during disconnection, bacterial growth due to reuse, complications in conduit connections, and the need for authenticating thermal pads to ensure effective treatment.
A dual-lumen fluid delivery line (FDL) system with proximal and distal manifold hubs, featuring concentric lumens and latching mechanisms for secure connections, along with authentication tags to verify the authenticity of thermal pads, ensuring seamless fluid flow and preventing contamination.
The system minimizes fluid leakage during disconnection, reduces bacterial growth, simplifies conduit alignment, and ensures the use of authentic thermal pads, enhancing the effectiveness and safety of TTM treatments.
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Abstract
Description
[Technical field]
[0001] The present disclosure relates to fluid delivery lines and connection systems for targeted temperature management systems. [Background technology]
[0002] The effects of body temperature on the human body are well documented, and the use of targeted temperature management (TTM) systems to selectively cool and / or heat body tissues is known. An increase in body temperature, i.e., hyperthermia, can be detrimental to the brain under normal conditions, and more importantly, during periods of physical stress, such as illness or surgery. Conversely, a decrease in body temperature, i.e., mild hypothermia, can provide some degree of neuroprotection. Moderate to severe hypothermia tends to be more detrimental to the body, particularly the cardiovascular system.
[0003] Targeted temperature management can be viewed from two different aspects. The first aspect of temperature management involves treating abnormal body temperature, i.e., cooling the body in hyperthermic conditions or warming the body in hypothermic conditions. The second aspect of thermoregulation is an advanced treatment that employs techniques to physically control the patient's temperature to provide physiological benefits, such as cooling stroke patients to provide some degree of neuroprotection. As an example, TTM systems may be utilized in early stroke treatment to reduce neurological damage from stroke and head trauma patients. Further applications include selective heating / cooling of patients during surgical procedures such as cardiopulmonary bypass surgery.
[0004] A TTM system circulates a fluid (e.g., water) through one or more thermal contact pads coupled to the patient to affect surface-to-surface thermal energy exchange with the patient. Generally, a TTM system includes a TTM fluid control module coupled to a set of thermal contact pads via fluid delivery lines. One such TTM system is disclosed in U.S. Pat. No. 5,399,343, entitled "Patient Temperature Control System with Fluid Pressure Maintenance," filed October 11, 2001, and one such thermal contact pad and associated system is disclosed in U.S. Pat. No. 5,399,343, entitled "Cooling / heating Pad and System," filed January 4, 1999, both of which are incorporated herein by reference in their entireties. The fluid delivery lines generally include two fluid conduits that transport the TTM fluid to and from the set of thermal pads. The thermal pads may include connectors that facilitate connection and disconnection to and from the fluid delivery lines. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] U.S. Patent No. 6,645,232 [Patent Document 2] U.S. Patent No. 6,197,045 Summary of the Invention
[0006] SUMMARY OF THE DISCLOSURE Embodiments herein relate generally to selectively raising and / or lowering a patient's body temperature, and in particular embodiments, to systems and methods for controlling a patient's body temperature via circulation of a heated / cooled fluid through one or more pads in contact with the patient.
[0007] Disclosed herein is a fluid delivery line (FDL) used to transport TTM fluid between a TTM module and one or more thermal contact pads applied to a patient. The FDL includes a proximal FDL connector, an FDL conduit, and a pair of distal manifold hubs. The proximal FDL connector is at a proximal end of the FDL. The proximal FDL connector is configured to connect with the TTM module. The FDL conduit includes a fluid delivery lumen, a fluid return lumen in a side-by-side arrangement with the fluid delivery lumen, and an FDL conduit branch defining a pair of FDL conduit legs. The pair of distal manifold hubs are respectively coupled to the pair of FDL legs at a distal end of the FDL. Each distal manifold hub includes one or more distal hub connectors configured to respectively connect to one or more pad connectors of one or more thermal contact pads. Each distal hub connector of the one or more distal hub connectors includes a displaceable member configured to engage or disengage with the pad-hub latch mechanism to secure or release a corresponding pad connector of the one or more pad connectors, respectively, to the distal hub connector.
[0008] In some embodiments, the FDL further includes wiring that extends along the length of the FDL. In some embodiments, the proximal FDL connector is configured to fluidly, mechanically, and electrically connect with the TTM module.
[0009] In some embodiments, the one or more distal hub connectors are configured to fluidly, mechanically, and electrically connect with the one or more pad connectors, respectively.
[0010] In some embodiments, the displaceable member is a button. In some embodiments, the button is configured to, when pressed, disengage the latch mechanism, thereby allowing a corresponding pad connector of the one or more pad connectors to be released from the tip side hub connector of the one or more tip side hub connectors.
[0011] In some embodiments, the button is configured to, when pressed, disengage the latch mechanism, thereby allowing a corresponding pad connector of the one or more pad connectors to be secured to the distal hub connector of the one or more distal hub connectors.
[0012] In some embodiments, each distal hub connector of the one or more distal hub connectors includes a sealing member configured to define a seal with a valve of a corresponding pad connector of the one or more pad connectors when the corresponding pad connector is secured to the distal hub connector.
[0013] In some embodiments, the valves of a corresponding one of the one or more pad connectors are biased toward a closed state so that the valves of the corresponding pad connectors automatically close when the corresponding pad connector is disconnected from the distal hub connector.
[0014] Also disclosed herein is an FDL used to transport TTM fluid between the TTM module and a thermal contact pad applied to a patient. The FDL includes a bi-luminal fluid conduit extending from a proximal end to a distal end and a bi-luminal proximal FDL connector at the proximal end. The proximal FDL connector is configured to couple with the TTM module, with the two lumens of the proximal FDL connector being concentrically disposed. The bi-luminal distal connector at the distal end is configured to couple with a manifold hub. The bi-luminal distal connector includes a pair of valves, each valve aligned with a separate one of the two lumens. Each valve is configured to automatically block fluid flow through its respective lumen when the distal connector is disconnected from the manifold hub, and each valve is configured to automatically enable / permit fluid flow through its respective lumen when the distal connector is connected to the manifold hub.
[0015] The distal connector can include a latch mechanism having a displaceable member such that when the displaceable member is in a displaced state, the distal connector can be pulled away from the manifold hub and when the displaceable member is in a non-displaced state, the distal connector can be prevented from being pulled away from the manifold hub. The two lumens of the distal connector can be concentrically disposed.
[0016] In some embodiments, coupling the proximal FDL connector to the TTM module includes connecting the proximal FDL connector to a module connector of the TTM module and pivoting the proximal FDL connector such that a longitudinal axis of the proximal FDL connector pivots from a substantially horizontal orientation to a substantially vertical orientation (or vice versa).
[0017] The proximal FDL connector can be configured to latch to the TTM module such that when the proximal FDL connector is oriented horizontally, the latching mechanism is released, allowing separation of the proximal FDL connector from the adapter, and when the proximal FDL connector is oriented vertically, the latching mechanism is activated, preventing separation of the proximal FDL connector from the adapter. It should be noted that the horizontal and vertical orientations may be reversed in alternative embodiments.
[0018] The proximal FDL connector can include a pair of proximal valves, each proximal valve aligned with a separate one of two lumens of the proximal FDL connector, each proximal valve configured to automatically block fluid flow through its respective lumen when the proximal FDL connector is disconnected from the TTM module, and each proximal valve configured to automatically allow fluid flow through its respective lumen when the proximal FDL connector is connected to the TTM module.
[0019] In some embodiments, the FDL includes an authentication tag configured to provide FDL authentication data to the TTM module. In some embodiments, the FDL is coupled to a manifold hub, the hub including a plurality of dual lumen distal hub connectors configured to couple to a plurality of thermal contact pads, in other embodiments, the FDL is coupled to two or more manifold hubs, each manifold hub including a plurality of dual lumen distal hub connectors configured to couple to a plurality of thermal contact pads.
[0020] In some embodiments, the two lumens of the fluid conduit are concentric along at least a portion of the fluid conduit. Also disclosed herein is a thermal contact pad assembly for exchanging thermal energy between a TTM fluid and a patient. The assembly includes a thermal contact pad and a manifold hub. The pad includes a pad portion configured to be placed on a patient, a dual lumen fluid conduit extending proximally away from the pad portion, and a dual lumen pad connector coupled to the fluid conduit at a proximal end. The hub includes a housing, a dual lumen distal hub connector coupled to the dual lumen pad connector, and a dual lumen proximal hub connector configured to couple to a dual lumen FDL of a TTM system. The TTM fluid flows through the housing between flowing through the dual lumen distal hub connector and flowing through the dual lumen proximal hub connector. The dual lumen proximal hub connector includes two lumens that can be arranged in a concentric arrangement.
[0021] In some embodiments, the dual lumen proximal hub connector includes a pair of valves, each valve aligned with a different one of the two lumens, and each valve configured to automatically block fluid flow through its respective lumen when the dual lumen proximal hub connector is disconnected from the FDL, and to automatically allow fluid flow through its respective lumen when the dual lumen proximal hub connector is connected to the FDL.
[0022] The dual lumen proximal hub connector can be configured to couple with the FDL via a proximal latch mechanism, the proximal latch member including a displaceable member configured to allow separation of the dual lumen proximal hub connector from the FDL when the displaceable member is in a displaced state and to prevent separation of the dual lumen proximal hub connector from the FDL when the displaceable member is in a non-displaced state.
[0023] In some embodiments, each dual lumen distal hub connector in combination with a corresponding pad connector includes a distal latch mechanism, and at least one of the dual lumen distal hub connector or the pad connector includes a displaceable member of the distal latch mechanism configured to allow separation of the pad connector from the dual lumen distal hub connector when the displaceable member of the distal latch mechanism is in a displaced state and to prevent separation of the pad connector from the dual lumen distal hub connector when the displaceable member of the distal latch mechanism is in a non-displaced state.
[0024] The manifold hub can include a plurality of dual lumen distal hub connectors, each dual lumen distal hub connector configured to couple with a pad connector, each dual lumen distal hub connector including a pair of valves, each valve of the distal hub connector aligned with a separate one of the two lumens, each valve of the distal hub connector configured to automatically block fluid flow through its respective lumen when the dual lumen distal hub connector is disconnected from the pad connector and to automatically allow fluid flow through its respective lumen when the dual lumen distal hub connector is coupled with the pad connector.
[0025] In some embodiments, the two lumens of the dual lumen distal hub connector are concentrically arranged. The assembly can further include a plurality of thermal contact pads coupled to the manifold hub via the plurality of dual lumen distal hub connectors. The assembly can further include an authentication tag attached to at least one of the thermal contact pads or the manifold hub, the authentication tag configured to provide authentication data to a TTM module of the TTM system. The manifold hub can include an attachment device configured to couple the manifold hub to at least one of the thermal contact pads, a bed surface, or a bed rail.
[0026] Also disclosed herein is a TTM system including a TTM module configured to deliver a TTM fluid. The system further includes a thermal pad configured to facilitate thermal energy transfer between the TTM fluid and a patient, the thermal pad including a pad portion configured to be placed on the patient and a dual lumen fluid conduit extending proximally away from the pad portion. The system further includes a dual lumen FDL configured to transport the TTM fluid between the TTM module and the thermal pad, the dual lumen FDL including a proximal dual lumen FDL connector at a proximal end of the dual lumen FDL and a distal dual lumen FDL connector at a distal end of the dual lumen FDL. The system further includes a manifold hub coupled to the dual lumen FDL at the distal end of the dual lumen FDL, the manifold hub configured to facilitate a dual lumen fluid connection between the dual lumen FDL and the dual lumen fluid conduit. Coupling the dual lumen FDL to the TTM module includes coupling a proximal dual lumen FDL connector of the FDL to a dual lumen module connector of the TTM module, the proximal dual lumen FDL connector including two concentric lumens. Coupling the dual lumen FDL to the TTM module also includes opening a pair of valves of the TTM module to allow bidirectional flow of the TTM fluid through the dual lumen module connector, each valve aligned with a separate one of the two lumens of the dual lumen module connector. The two lumens of the proximal FDL connector can be concentric.
[0027] The system can further include a connection adapter attached to the TTM module, the connection adapter including a pair of valves and a dual lumen module connector. The connection adapter can include an adapter console including a controller having a processor and controller logic stored in a memory, the controller logic configured to selectively open and close the pair of valves.
[0028] The adapter console can further include an authentication module configured to obtain authentication data from an authentication tag attached to at least one of the FDL, the manifold hub, or the thermal pad. The controller logic can be configured to open the pair of valves when the obtained authentication data matches the authentication information stored in the memory.
[0029] The connection adaptor can include a latching mechanism configured to secure the proximal FDL connector to the connection adaptor. The latching mechanism includes a pivot member coupled to the proximal FDL connector such that the proximal FDL connector is rotatable between a horizontal and a vertical orientation. The latching mechanism is further configured such that when the proximal FDL connector is oriented in a horizontal orientation, the latching mechanism is released, allowing separation of the proximal FDL connector from the connection adaptor, and when the proximal FDL connector is oriented in a vertical orientation, the latching mechanism is activated, preventing separation of the proximal FDL connector from the connection adaptor.
[0030] The latch mechanism may further include a clip configured to engage the proximal FDL connector, thereby vertically restraining the proximal FDL connector. In some embodiments, the manifold hub is coupled to the FDL via a dual lumen proximal hub connector having a pair of hub valves, each hub valve aligned with a separate one of the two lumens of the proximal hub connector, and each hub valve configured to automatically block fluid flow through its respective lumen when the proximal hub connector is disconnected from the FDL, and to automatically allow fluid flow through its respective lumen when the proximal hub connector is connected to the FDL.
[0031] The proximal hub connector can be configured to couple with the FDL via a proximal latch mechanism that includes a displaceable member that allows the proximal hub connector to be pulled away from the FDL when the displaceable member is in a displaced state and prevents the proximal hub connector from being pulled away from the FDL when the displaceable member is in a non-displaced state.
[0032] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the following description and accompanying drawings, which describe in more detail certain embodiments of such concepts.
[0033] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It is to be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]
[0034] [Figure 1A] 1 illustrates a current embodiment of a TTM system for cooling or warming a patient. [Figure 1B] 1 illustrates an improved TTM system, according to some embodiments. [Diagram 2] 1C illustrates a hydraulic circuit diagram of the TTM system of FIG. 1B according to some embodiments. [Diagram 3] 1C shows a block diagram illustrating various elements of the console of the TTM module of FIG. 1B in accordance with some embodiments. [Figure 4A] FIG. 1C is a top view of a thermal pad of the system of FIG. 1B according to some embodiments. [Figure 4B] FIG. 4B is a cross-sectional view of the pad of FIG. 4A taken along section line 4B-4B according to some embodiments. [Figure 5A] 1C illustrates an embodiment of the FDL of FIG. 1B, according to some embodiments. [Figure 5B] 1 is a cross-sectional view of a fluid delivery line conduit according to some embodiments. [Figure 5C] 1 illustrates an FDL-hub connection system in which the FDL connector includes a displaceable latch member, according to some embodiments. [Figure 6]1 illustrates an embodiment of a branched fluid delivery line, according to some embodiments. [Figure 7A] 1 illustrates a coaxial dual lumen connection system including a valve in a disconnected state according to some embodiments. [Figure 7B] 7B illustrates the connection system of FIG. 7A in a connected state, according to some embodiments. [Figure 8A] 1 illustrates a pad-hub connection system having a push-pull mechanism according to some embodiments. [Figure 8B] 1 illustrates a pad-hub connection system in which the pad connector includes a displaceable member, according to some embodiments. [Figure 8C] 1 illustrates a pad-hub connection system in which the hub connector includes a displaceable member, according to some embodiments. [Figure 8D] 1 illustrates a pad-hub connection system in which the pad connector includes a displaceable shroud, according to some embodiments. [Figure 8E] 1 illustrates a pad-hub connection system including an interlocking teeth arrangement according to some embodiments. [Figure 8F] 8E illustrates the pad-hub connection of FIG. 8D in a partially connected state according to some embodiments. [Figure 8G] 8D in a fully connected state, according to some embodiments. [Figure 9A] 1C illustrates the module-FDL connection adapter of FIG. 1B according to some embodiments. [Figure 9B] 9B illustrates the module-FDL connection adapter of FIG. 9A coupled to an FDL, according to some embodiments. [Figure 9C] 9C shows a cross-sectional top view of the adapter of FIG. 9B taken along section line 9C-9C, according to some embodiments. [Figure 9D] 1 illustrates a block diagram showing various elements of a console of a module-FDL connection adapter according to some embodiments. [Figure 10A]1 illustrates a manifold hub having multiple distal hub connectors arranged in a row according to some embodiments. [Figure 10B] 10B illustrates the hub of FIG. 10A coupled with a thermal pad, according to some embodiments. [Figure 10C] 10B shows the hub of FIG. 10A coupled with a bed surface according to some embodiments. [Figure 11A] 1 illustrates a manifold hub having multiple distal hub connectors disposed around the circumference of the hub, according to some embodiments. [Figure 11B] 11B illustrates the hub of FIG. 11A positioned on a bed surface, according to some embodiments. [Figure 11C] 11B illustrates the hub of FIG. 11A attached to a thermal pad, according to some embodiments. [Figure 11D] FIG. 11B shows the underside of the hub of FIG. 11A including an add-on clip, according to some embodiments. [Figure 11E] 11D shows the hub of FIG. 11D clipped to a bedrail, according to some embodiments. [Figure 12] 1 illustrates another embodiment of a TTM system in accordance with some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are easily separable from the specific embodiment and that can, optionally, be combined with or substituted for features of any of the other several embodiments disclosed herein.
[0036] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment that includes such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", "horizontal", "vertical", etc. are used for convenience and are not intended to suggest, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. The words "including," "has," and "having" have the same meaning as the word "comprising" when used herein, including the claims. Furthermore, the terms "or" and "and / or" when used herein shall be construed to mean inclusive or any one or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A only, B only, C only, A and B, A and C, B and C, and A, B, and C." Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way essentially mutually exclusive.
[0037] The phrases "connected to" and "coupled to" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, signal, communication (including wireless), and thermal interactions. Two components can be connected or coupled to each other even if they are not in direct contact with each other. For example, two components can be coupled to each other through an intermediate component. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.
[0038] The directional terms "proximal" and "distal" are used herein to refer to opposing locations on a medical device. The proximal end of the device is defined as the end of the device that is closest to the end user when the device is in use by the end user. The distal end is the end along the length of the device opposite the proximal end, or the end that is furthest from the end user.
[0039] Any method disclosed herein includes one or more steps or acts of performing the described method. Method steps and / or acts may be interchanged with one another. In other words, the order and / or use of certain steps and / or acts may be changed unless a certain order of steps or acts is required for proper operation of the embodiment. Furthermore, only subroutines or portions of the methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only some of the steps described in a more detailed method.
[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A shows a current embodiment of a TTM system 10 for cooling or warming a patient 50. The TTM system 10 includes a TTM module 11, an FDL 13, and a thermal contact pad set 12. The pad set 12 can generally include 1, 2, 3, 4, 5, 6, or more thermal contact pads. The FDL 13 allows for the transport of TTM fluid to and from the pad set 12. The FDL 13 can include a hub 14 at a tip to which multiple thermal pads can be connected.
[0041] In some cases, the patient 50 may need to undergo a medical procedure during a TTM therapy session. Some procedures, such as MRI procedures, may require the patient 50 to be separated from the TTM module 11. In such cases, it may be advantageous to leave the thermal contact pad set 12 in contact with the patient 50 (e.g., applied to the patient) and to separate the thermal pad set from the FDL 13. To minimize leakage of TTM fluid from the thermal pads and FDL 13, a purge of the TTM fluid from the pad set 12 and FDL 13 may be performed. Purging of the TTM fluid may cause undesirable delays in providing the required procedure. Therefore, it may be advantageous to provide a connection system between the hub 14 and the FDL 13 that seals the TTM fluid in the pad set 12 and FDL 13 so that leakage of the TTM fluid during separation may be avoided or minimized.
[0042] In some cases, reusing the FDL 13 multiple times may result in bacterial growth within the FDL 13. Thus, clinicians may clean and / or disinfect the FDL 13 at regular intervals, such as before each reuse. In some cases, reliance on cleaning and disinfection procedures in healthcare environments has been shown to be ineffective in ensuring that patients are not contaminated. There is a trend away from reusing medical devices toward single-use devices to reduce reliance on disinfection procedures.
[0043] In further cases, the use of inferior heating pads manufactured by third parties may result in less effective TTM treatment for the patient. Therefore, it may be advantageous to detect attempts to use inferior heating pads before initiating TTM treatment. Current technology, such as radio frequency identification (RFID) tags, makes it possible and economically feasible to verify the authenticity of single-use devices such as heating pads, thereby preventing the potential delivery of ineffective TTM treatment.
[0044] In some cases, connecting fluid conduits, such as connecting the FDL 13 to the TTM module 11, may have complications or challenges, such as orientation and alignment, that can be eliminated by reconfiguring the connection points between them. For example, a parallel arrangement for two fluid conduits may present complications when making connections, which can be avoided by placing the two lumens coaxially.
[0045] FIG. 1B illustrates an improved TTM system 100 that can provide enhancements in some of the areas discussed above. The TTM system 100 includes a TTM module 110, an FDL 130, and a thermal contact pad set 120. In the illustrated embodiment, the pad set 120 includes four thermal contact pads. However, the pad set 120 may include one or more thermal contact pads. The FDL 130 is dual lumen facilitating delivery of the TTM fluid 112 to the pad set 120 via a fluid delivery lumen 131 and return of the TTM fluid 112 to the TTM module 110 via a fluid return lumen 132. In the illustrated embodiment, the FDL 130 is coupled to a manifold hub 140. The hub 140 can include one or more distal hub connectors that facilitate fluid connection to the thermal pads. In one embodiment, the hub 140 includes six distal hub connectors. 1B, the hub 140 includes four distal hub connectors. The hub 140 is also selectively coupled to the FDL 130. A more detailed description of the hub 140 follows. The TTM system 100 also includes a connection adapter 150 between the FDL 130 and the TTM module 110 to provide an improved fluid connection between the FDL 130 and the TTM module 110.
[0046] In some embodiments, one or more thermal pads of the pad set 120 can be packaged with the hub 140 to define a thermal pad set assembly. In some embodiments of the pad set assembly, the hub 140 may be pre-connected to one or more pads of the pad set 120.
[0047] In use, the TTM module 110 prepares the TTM fluid 112 for delivery to the pad set 120 by heating or cooling the TTM fluid 112 to a prescribed temperature according to prescribed TTM treatment parameters entered by a clinician via a graphical user interface (GUI) 115. The TTM module 110 circulates the TTM fluid 112 between the TTM module 110 and the pad set 120 via the FDL 130. The pad set 120 is applied to the skin 51 of the patient 50 to facilitate thermal energy exchange between the pad set 120 and the patient 50. During a TTM treatment, the TTM module 110 can continuously control the temperature of the TTM fluid 112 towards a target TTM temperature.
[0048] 2 shows a hydraulic schematic of the TTM system 100. The pad set 120 (FIG. 1B) along with corresponding fluid conduits are located external to the housing 111 of the TTM module 110. The TTM module includes various fluid sensors and fluid control devices for preparing and circulating the TTM fluid 112. The fluid subsystems of the TTM module can include a temperature control subsystem 210 and a circulation subsystem 230.
[0049] The temperature control subsystem 210 may include a chiller pump 211 for pumping (recirculating) the TTM fluid 112 through a chiller circuit 212, which includes a chiller 213 and a chiller tank 214. A temperature sensor 215 in the chiller tank 214 is configured to measure the temperature of the TTM fluid 112 in the chiller tank 214. The chiller 213 may be controlled by temperature control logic (see FIG. 3), as described further below, to establish a desired temperature of the TTM fluid 112 in the chiller tank 214. In some cases, the temperature of the TTM fluid 112 in the chiller tank 214 may be less than a target temperature for the TTM treatment.
[0050] The temperature control subsystem 210 may further include a mixing pump 221 that pumps the TTM fluid 112 through a mixing circuit 222 that includes a chiller tank 214, a circulation tank 224, and a dam 228 disposed between the chiller tank 214 and the circulation tank 224. As the TTM fluid 112 is pumped by the mixing pump 221, it enters the chiller tank 214 and is mixed with the TTM fluid 112 in the chiller tank 214. The mixed TTM fluid 112 in the chiller tank 214 flows over the dam 228 into the circulation tank 224. In other words, the mixing circuit 222 mixes the TTM fluid 112 in the chiller tank 214 with the TTM fluid 112 in the circulation tank 224 to cool the TTM fluid 112 in the circulation tank 224. A temperature sensor 225 in the circulation tank 224 measures the temperature of the TTM fluid 112 in the circulation tank 224. The temperature control logic can control the mixing pump 221 according to temperature data from a temperature sensor 225 in the circulation tank 224 .
[0051] The circulation tank 224 includes a heater 227 that increases the temperature of the TTM fluid 112 in the circulation tank 224, and the heater 227 may be controlled by temperature control logic. In summary, the temperature control logic, when executed by a processor (see FIG. 3), can 1) receive temperature data from the temperature sensor 215 in the chiller tank and the temperature sensor 225 in the circulation tank 224, and 2) control the operation of the chiller 213, chiller pump 211, heater 227, and mixing pump 221 to establish and maintain the temperature of the TTM fluid 112 in the circulation tank 224 at a target temperature for the TTM treatment.
[0052] The circulation subsystem 230 includes a circulation pump 231 that draws the TTM fluid 112 from the circulation tank 224 through a circulation circuit 232 that includes the pad set 120 located upstream of the circulation pump 231. The circulation circuit 232 also includes a pressure sensor 237 that represents the pressure of the TTM fluid 112 in the pad set 120. The circulation circuit 232 also includes a temperature sensor 235 in the circulation tank 224 that represents the temperature of the TTM fluid 112 entering the pad set 120 and a temperature sensor 236 that represents the temperature of the TTM fluid 112 exiting the pad set 120. A flow meter 238 is positioned downstream of the circulation pump 231 to measure the flow rate of the TTM fluid 112 through the circulation circuit 232 before the TTM fluid 112 re-enters the circulation tank 224.
[0053] The circulation tank 224, which may be vented to atmosphere, is located below (i.e., at a lower elevation than) the pad set 120 so that, in use, the pressure within the pad set 120 is less than atmospheric pressure (i.e., negative pressure) when TTM fluid flow through the circulation circuit 232 is stopped. The pad set 120 is also located upstream of the circulation pump 231 to further establish a negative pressure within the pad set 120 when the circulation pump 231 is operating. Fluid flow control logic (see FIG. 3) may control the operation of the circulation pump 231 to establish and maintain a desired negative pressure within the pad set 120. A supply tank 240 supplies the TTM fluid 112 to the circulation tank 224 via port 241 to maintain a defined volume of TTM fluid 112 within the circulation tank 224.
[0054] 3 shows a block diagram illustrating various elements of the TTM module 110 of FIG. 1B, according to some embodiments. The TTM module 110 includes a console 300, which includes a processor 310 and a memory 340, which includes a non-transitory computer readable medium. Logic modules stored in the memory 340 include patient treatment logic 341, fluid temperature control logic 342, fluid flow rate control logic 343, and pad identification logic 344. The logic modules, when executed by the processor 310, define the operation and functionality of the TTM module 110.
[0055] The block diagram of Figure 3 illustrates the fluid sensors 320 described above in relation to Figure 2. Each of the fluid sensors 320 is coupled to the console 300 such that data from the fluid sensors 320 can be utilized in performing the TTM module operations. In Figure 3, a fluid controller 330 is also shown coupled to the console 300. Thus, the logic module can control the operation of the fluid controller 330, as described further below.
[0056] The patient treatment logic 341 can receive input from a clinician via the GUI 115 to establish operating parameters according to a prescribed TTM treatment. The operating parameters can include a target temperature of the TTM fluid 112 and / or a thermal energy exchange rate, which can include a time-based target temperature profile. In some embodiments, the fluid temperature control logic 342 can define other fluid temperatures of the TTM fluid 112 in the TTM module 110, such as a target temperature of the TTM fluid 112 in the chiller tank 214.
[0057] The fluid temperature control logic 342 can perform operations to establish and maintain the temperature of the TTM fluid 112 delivered to the pad set 120 according to a predefined target temperature. One temperature control operation can include cooling the TTM fluid 112 in the cooler tank 214. The fluid temperature control logic 342 can utilize temperature data from the cooler tank temperature sensor 215 to control the operation of the cooler 213 to establish and maintain the temperature of the TTM fluid 112 in the cooler tank 214.
[0058] Another temperature control operation may include cooling the TTM fluid 112 in the circulation tank 224. Using temperature data from the circulation tank temperature sensor 225, the fluid temperature control logic 342 may control the operation of the mixing pump 221 to lower the temperature of the TTM fluid 112 in the circulation tank 224 by mixing the TTM fluid 112 from the chiller tank 214 with the TTM fluid 112 in the circulation tank 224.
[0059] Yet another temperature control operation may include warming the TTM fluid 112 in the circulating tank 224. The fluid temperature control logic 342 may utilize temperature data from the circulating tank temperature sensor 225 to control the operation of the heater 227 to increase the temperature of the TTM fluid 112 in the circulating tank 224.
[0060] The fluid flow control logic 343 can control the operation of the circulation pump 231. Because the rate of thermal energy exchange is at least partially determined by the flow rate of the TTM fluid 112 through the pad set 120, the fluid flow control logic 343 can, in some embodiments, control the operation of the circulation pump 231 according to a prescribed rate of thermal energy exchange for the TTM treatment.
[0061] The console 300 may include or be coupled to a wireless communication module 312 to facilitate wireless communication with external devices. A power supply 360 provides power to the console 300. The console 300 is coupled to a connection adapter console 350, as described further below.
[0062] 4A shows a top view of a thermal contact pad 421, which may be any of the pads of the pad set 120. The following description describes features, components and details of the pad 421, but the following description may be equally applicable to any and all other thermal contact pads of the pad set 120. A dual lumen fluid conduit 440 includes a fluid delivery conduit 441 and a fluid return conduit 442 that extend proximally away from a fitting 450, according to some embodiments. As shown, the fitting 450 may provide a rotatable connection between the fluid delivery conduit 441 and the fluid return conduit 442 and the pad portion 405 of the pad 421. The rotatable connection allows the fluid conduit to rotate through an angle 455 ranging from about 90 degrees, 180 degrees, 360 degrees or more. In some embodiments, one of the fittings 450 may define a fixed rotatable connection, i.e., the fitting may allow rotation but not separation. In other embodiments, one or more of the fittings 450 can define a pre-assembled rotatable connection that allows for rotation and separation by the clinician. A dual lumen pad connector 471 is coupled to the fluid conduit 440 at the proximal end. The pad connector 471 can employ any or all of the parts of the connection system 700 (see Figures 7A and 7B, described below).
[0063] In some embodiments, the pad 421 may include a pad authentication tag 457. The authentication tag 457 may be attached to any portion of the pad 421, such as the pad connector 471, the fluid conduit 440, or the pad portion 405. The authentication tag 457 may be configured to provide pad authentication information or data to a wireless data receiving device via wireless or wired communication, as further described below. The authentication information may include pad identification information, such as a manufacturing identification. The authentication information may also include product specific information, such as a model designation or part number.
[0064] FIG. 4B shows a side cross-sectional view of the pad portion 405 of the thermal contact pad 421 of FIG. 4A in contact with the patient 50, according to some embodiments. The pad 421 may include multiple layers that provide multiple functions of the pad 421. The fluid containing layer 420 is fluidly coupled to a fluid delivery conduit 441 via fittings 450 to facilitate circulation of the TTM fluid 112 within the fluid containing layer 420. Similarly, (not shown in FIG. 4B) the fluid containing layer 420 is fluidly coupled to a fluid return conduit 442 via one of the fittings 450. The fluid containing layer 420, through which the TTM fluid 112 circulates, defines a heat sink or heat source for the patient 50, depending on the temperature of the TTM fluid 112. The fluid delivery conduit 441 may also be coupled to an internal fluid conduit 426 of the fluid containing layer 420, such that the TTM fluid 112 entering the fluid containing layer 420 passes through the internal fluid conduit 426.
[0065] The pad 421 may include a thermally conductive layer 430 disposed between the fluid-containing layer 420 and the patient 50. The thermally conductive layer 430 is configured to facilitate thermal energy transfer between the fluid-containing layer 420 and the patient 50. The thermally conductive layer 430 may be attached to the thermally conductive layer 430 along a bottom surface of the fluid-containing layer 420. The thermally conductive layer 430 may be conformable to provide intimate contact with the patient 50. In other words, the thermally conductive layer 430 may conform to the contours of the patient 50 to prevent the presence of spaces or air pockets between the thermally conductive layer 430 and the patient 50.
[0066] The pad 421 may include an insulating layer 410 disposed over the fluid containing layer 420. The insulating layer 410 is configured to inhibit thermal energy transfer between the fluid containing layer 420 and the environment. The insulating layer 410 may be attached to the fluid containing layer 420 along a top surface 422 of the fluid containing layer 420. In some embodiments, the insulating layer 410 may include one or more openings 411 extending through the insulating layer 410 to provide coupling between the fluid delivery conduit 441 and the fluid return conduit 442 and the fluid containing layer 420.
[0067] One of the fittings 450 may include an elbow 460 that redirects the fluid delivery conduit 441 extending away from the fitting. As shown, the orientation of the fluid delivery conduit 441 is redirected from an orientation perpendicular to the pad 421 to an orientation substantially parallel to the pad 421. The elbow 460 also establishes an orientation of a tip portion 461 of the fluid delivery conduit 441 to be substantially parallel to the pad 421 and / or the fluid containing layer 420.
[0068] FIG. 5A illustrates one embodiment of an FDL 130 and associated features and components coupled to a hub 140. The FDL 130 includes a proximal FDL connector 532 for coupling with a connection adapter 150, a distal FDL connector 533 for coupling with the hub 140, and a dual lumen FDL conduit 531 extending from the proximal FDL connector 532 to the distal FDL connector 533. The hub 140 includes a proximal hub connector 543 configured to couple with the distal FDL connector 533. The hub 140 also includes one or more distal hub connectors 571 for connecting to the thermal pad set 120. Each distal hub connector of the one or more distal hub connectors 571 is configured to couple with a corresponding pad connector 471. In some embodiments, the one or more distal hub connectors 571 can be located on both sides of the hub 140. In the illustrated embodiment of FIG. 5A, three distal hub connectors 571 are located on both sides of the hub 140. The distal hub connector 571 can be oriented such that the thermal pad fluid conduits 440 extend away from either side of the hub 140 in a direction perpendicular to the FDL conduits 531. One or more of the distal hub connector 571, the proximal hub connector 543, the distal FDL connector 533, and the proximal FDL connector 532 can employ any or all parts of the connection system 700 (see Figures 7A and 7B, described below).
[0069] The FDL 130 may be fitted with an FDL authentication tag 557. The FDL authentication tag 557 may be fitted to any portion of the FDL 130, such as the proximal FDL connector 532 (as shown), the FDL conduit 531, or the distal FDL connector 533. The FDL authentication tag 557 may be configured to provide FDL authentication information, as described further below. The FDL authentication information may include FDL identification information, such as a manufacturing identification. The FDL authentication information may also include product specific information, such as an FDL model designation or FDL part number. In some embodiments, the FDL authentication information may include manufacturing information, such as a manufacturing date range or lot number. As described below with respect to FIGS. 9A-9D, the FDL connectors 532 and 533 and the FDL conduit 531 may be coupled with wires 535 that extend through the length of the FDL 130.
[0070] In some embodiments, the hub 140 may be fitted with a hub authentication tag 547. The hub authentication tag 547 may be configured to wirelessly provide hub authentication information or data to a wireless data receiving device, as further described below. The hub authentication information may include hub identification information, such as a manufacturing identification. The hub authentication information may also include product specific information, such as a hub model designation or hub part number. In some embodiments, the hub authentication information may include manufacturing information, such as a manufacturing date range or lot number. In some embodiments, the hub authentication tag 547 may be an RFID tag.
[0071] 5B is a cross-sectional view of the FDL conduit 531. In some embodiments, the two lumens of the FDL conduit 531 can be arranged in a concentric arrangement. As shown in FIG. 5B, the fluid delivery lumen 534A can be arranged within the fluid return lumen 534B. Such an arrangement can facilitate equal flexibility of the FDL conduit 531 in all directions. The concentric arrangement can also minimize changes in temperature of the TTM fluid 112 as it flows through the fluid delivery lumen 534a toward the patient 50. In other embodiments, the two lumens of the FDL conduit 531 can be arranged in a parallel arrangement.
[0072] 5C illustrates an FDL-hub connection system including a distal FDL connector 533 and a proximal hub connector 543. The distal FDL connector 533 and the proximal hub connector 543 facilitate selective connection and disconnection of the FDL 130 to the hub 140. Each of the distal FDL connector 533 and the proximal hub connector 543 is a dual lumen connector that facilitates bidirectional flow of TTM fluid therethrough. As shown, the arrangement of the two lumens at the connection point is concentric, such that the distal FDL connector 533 and the proximal hub connector 543 can be rotated relative to one another while maintaining bidirectional flow of TTM fluid therethrough. The concentric lumen arrangement also facilitates coupling of the distal FDL connector 533 to the proximal hub connector 543 at any relative angular orientation therebetween. The distal FDL connector 533 and the proximal hub connector 543 can employ any or all parts of the connection system 700 (see FIGS. 7A and 7B, described below). In some embodiments, the distal FDL connector 533 and the proximal hub connector 543 can be omitted such that the FDL conduit 531 is fixedly coupled to the hub 140.
[0073] The FDL-hub connection system may also include a latching mechanism to prevent inadvertent separation of the distal FDL connector 533 from the proximal hub connector 543. In the illustrated embodiment, the FDL-hub connection system includes an exemplary ring-in-groove latching mechanism in which a ring 552 of the distal FDL connector 533 selectively engages a groove 542 of the proximal hub connector 543. In other words, when the distal FDL connector 533 and the proximal hub connector 543 are coupled together, the ring 552 is disposed within the groove 542, thereby preventing displacement of the FDL connector 533 away from the proximal hub connector 543. In the illustrated embodiment, the ring 552 may be biased into engagement with the groove 542.
[0074] Ring 552 is operatively coupled to a displaceable member, such as button 551, such that when button 551 is depressed, ring 552 disengages from groove 542, thereby allowing separation of distal FDL connector 533 from proximal hub connector 543. In use, a clinician can depress button 551 while coupling and / or uncoupling connectors 533 and 543 from one another.
[0075] FIG. 6 illustrates an embodiment of an FDL 630 having a proximal FDL connector 632 at a proximal end and a branching FDL conduit 631 defining FDL legs 631A and 631B. In the illustrated embodiment, the FDL 630 couples to two manifold hubs 640. Each leg includes a distal FDL connector 633 coupled to a proximal hub connector 643 of one of the hubs 640. The proximal hub connector 643 is selectively coupled to a corresponding distal FDL connector 633. The distal hub connector 671, the proximal hub connector 643, the distal FDL connector 633, and the proximal FDL connector 632 can employ any or all parts of a connection system 700 (see FIGS. 7A and 7B, described below). In some embodiments, the distal FDL connector 633 and the proximal hub connector 643 may be omitted such that the FDL conduit 631 is fixedly coupled to the hub 640.
[0076] The bifurcated FDL 630 can provide enhanced positioning of the FDL 630 and fluid conduits 440 (FIG. 4A) for each pad of the pad set 120. For example, the leg 631A, along with its associated one of the hubs 640, can be positioned along one side of the patient 50 where it can connect to three of the six thermal pads of the pad set 120. The other leg 631B, along with its associated hub 640, can be positioned along the other side of the patient 50 where it can connect to the other three of the six thermal pads of the pad set 120. In some embodiments, the hub 640 can be directly and permanently attached to the FDL legs 631A and 631B. In such embodiments, the distal FDL connector 633 and the proximal hub connector 643 can be omitted.
[0077] Figures 7A and 7B show a dual lumen connection system 700 including a first connector 710 and a second connector 750. Figure 7A shows a cross-sectional view of the first connector 710 and the second connector 750 of the connection system 700 in a disconnected state, and Figure 7B shows a similar cross-sectional view of the connection system 700 in a connected state.
[0078] The connection system 700 is configured to connect dual lumen fluid conduits together such that bidirectional fluid flow through the dual lumen fluid conduits is maintained throughout the connection system 700. The first connector 710 includes a first delivery lumen 711 and a first return lumen 712, and the second connector 750 includes a second delivery lumen 751 and a second return lumen 752. The connection system 700 is configured such that when the first connector 710 is mated with the second connector 750, the first delivery lumen 711 is in fluid communication with the second delivery lumen 751 and the first return lumen 712 is in fluid communication with the second return lumen 752. As shown, the first delivery lumen 711 and the second delivery lumen 751 are concentrically disposed within the first return lumen 712 and the second return lumen 752 of the annular fluid return at the connection point.
[0079] As also shown, the first delivery lumen 711 and the first return lumen 712 can be arranged in a side-by-side configuration at the conduit coupling end 710A of the first connector 710. Thus, the first connector 710 is configured to couple with a dual lumen fluid conduit having fluid lumens arranged in a side-by-side configuration. As can be appreciated by one skilled in the art, the side-by-side configuration of the first delivery lumen 711 and the first return lumen 712 can also be adapted to couple the first connector 710 with a dual lumen fluid conduit having concentrically arranged fluid lumens, where the first delivery lumen 711 is coupled with a central lumen of the fluid conduit and the first return lumen 712 is coupled with an annular lumen of the fluid conduit. Similarly, the conduit coupling end 750A of the second connector 750 is configured to couple with a dual lumen fluid conduit having fluid lumens arranged in a side-by-side or concentric configuration.
[0080] The connection system 700 is also configured to prevent fluid flow through the first and second delivery lumens 711, 751 and the first and second return lumens 712, 752 when the second connector 750 is decoupled from the first connector 710. The connection system 700 is also configured to minimize dripping of TTM fluid from the first and second connectors 710, 750 when the first and second connectors 710, 750 are decoupled from one another. The first connector 710 includes a first delivery valve 731 that closes the first delivery lumen 711 when the first connector 710 is decoupled. The first connector 710 further includes a first return valve 732 that closes the first return lumen 712 when the first connector 710 is decoupled. In summary, when the first connector 710 is decoupled from the second connector 750, fluid flow through the first connector 710 is prevented. First delivery valve 731 and first return valve 732 are biased to a closed state such that valves 731 and 732 automatically close when decoupled.
[0081] The second connector 750 includes a second delivery valve 771 that closes the second delivery lumen 751 when the second connector 750 is disconnected. The second connector 750 further includes a second return valve 772 that closes the second return lumen 752 when the second connector 750 is disconnected. In summary, when the second connector 750 is disconnected from the first connector 710, fluid flow through the second connector 750 is prevented. The second delivery valve 771 and the second return valve 772 are also biased to a closed state such that the second delivery valve 771 and the second return valve 772 automatically close when disconnected.
[0082] The first connector 710 and the second connector 750 include various structural elements. The first connector 710 and the second connector 750 include a first connector housing 713 and a second connector housing 753, respectively. The first connector 710 includes a sealing member 720 configured to perform various sealing functions of the first connector 710. The sealing member 720, or one or more portions thereof, can be formed of a deformable material, such as an elastomeric material, to define multiple fluid seals with corresponding sealing surfaces of the first connector housing 713 and the second connector housing 753. The sealing member 720 is displaceable between a bottom position when the first connector 710 is in a disconnected state as shown in FIG. 7A and a top position when the first connector 710 is in a connected state as shown in FIG. 7B. In the illustrated embodiment, the connection system 700 includes only one sealing member 720 that defines a fluid seal between the first connector 710 and the second connector 750.
[0083] The sealing member 720 includes a first delivery valve sealing element 722A configured to cover and seal one or more first delivery valve side ports 722B when the sealing member 720 is in a bottom position. When the sealing member 720 is in a top position, the first delivery valve sealing element 722A is displaced away from the first delivery valve side port 722B, exposing the first delivery valve side port 722B, thereby opening the first delivery valve 731.
[0084] The sealing member 720 includes a first return valve sealing element 721A configured to cover and seal one or more first return valve side ports 721B when the sealing member 720 is in a bottom position. When the sealing member 720 is in a top position, the first return valve sealing element 721A is displaced away from the first return valve side port 721B to expose the first return valve side port 721B, thereby opening the first return valve 732.
[0085] The sealing member 720 includes an outer connector sealing element 723 that defines a seal with the second connector housing 753. The connection system 700 is configured such that during a coupling process of the first connector 710 with the second connector 750, the outer sealing element 723 forms a seal with the second connector housing 753 before any of the valves 731, 732, 771, and 772 are opened to prevent leakage of the TTM fluid 112 during the coupling process. Similarly, during decoupling, all of the valves 731, 732, 771, and 772 are closed before decoupling the outer connector sealing element 723 from the second connector housing 753 to prevent leakage of the TTM fluid 112 during the decoupling process. The sealing member 720 further includes an inner connector sealing element 724 that defines a seal with the annular shelf 764 of the second connector 750. The first connector 710 includes a biasing member 714 that biases the sealing member 720 toward a bottom position. In some embodiments, the biasing member 714 may be a coil spring formed of a metallic or non-metallic material. Other forms of biasing member 714, such as a deflectable portion of the first connector housing 713 or the sealing member 720, are also contemplated and disclosed herein.
[0086] The second connector 750 includes a second delivery valve disk 761A and a corresponding second delivery valve port 761B. The second delivery valve disk 761A and the corresponding second delivery-valve port 761B combine to define a poppet-type valve. The second delivery valve disk 761A is displaceable between a top position when the second connector 750 is in a disconnected state as shown in FIG. 7A and a bottom position when the second connector 750 is in a connected state as shown in FIG. 7B. A biasing member 754 exerts a force on the second delivery valve disk 761A toward the second delivery valve port 761B to bias the second delivery valve 771 toward a closed state. Interaction between the first connector housing 713 and the second delivery valve disk 761A displaces the second delivery valve disk 761A downward to a bottom position to open the second delivery valve 771. The second delivery valve disc 761A, or a portion thereof, can be formed of a deformable material, such as an elastomeric material, to define a fluid seal with the second delivery valve port 761B. In some embodiments, the biasing member 754 can be a coil spring formed of a metallic or non-metallic material. Other forms of biasing member 754, such as a deflectable portion of the second connector housing 753 or the second delivery valve disc 761A, are also contemplated and disclosed herein.
[0087] The second connector 750 further includes a second return valve sealing ring 762A and a corresponding second return valve annular port 762B. The second return valve sealing ring 762A and the return valve annular port 762B combine to define an annular poppet-type valve. The second return valve sealing ring 762A is displaceable between a top position when the second connector 750 is in a disconnected state as shown in FIG. 7A and a bottom position when the second connector 750 is in a connected state as shown in FIG. 7B. A biasing member 755 exerts a force on the second return valve sealing ring 762A toward the return valve annular port 762B to bias the second return valve 772 toward a closed state. The interaction between the sealing member 720 and the second return valve sealing ring 762A displaces the second return valve sealing ring 762A downward to a bottom position to open the second return valve 772. The second return valve sealing ring 762A, or a portion thereof, can be formed of a deformable material, such as an elastomeric material, to define a fluid seal with the return valve annular port 762B. In some embodiments, the biasing member 755 can be a coil spring formed of a metallic or non-metallic material. Other forms of biasing member 755, such as a deflectable portion of the second connector housing 753 or the second return valve sealing ring 762A, are also contemplated and disclosed herein.
[0088] The dual lumen connection system 700 or a portion thereof may be employed in the TTM system 100 to define a fluid connection between any two fluid connection entities. For example, the connection system 700 or a portion thereof may be employed when the FDL 130 is connected to the connection adapter 150, when the FDL 130 is connected to the hub 140, or when the fluid conduit 440 of the pad set 120 is connected to the hub 140. In some embodiments, only a portion of the connection system 700 may be employed, such as one or more of the first delivery valve 731, the first return valve 732, the second delivery valve 771, or the second return valve 772. Similarly, in some embodiments, the first connector 710 or the second connector 750 may be attached to a dual lumen fluid conduit having two concentrically arranged lumens.
[0089] 8A-8G show various embodiments of pad-hub latching mechanisms, where the latching mechanism includes a displaceable member configured to release and / or actuate the latching mechanism. FIG. 8A shows a latching mechanism 871 that secures a pad connector 811 to a hub 841. The pad connector 811 includes a displaceable member 812 attached to a fluid conduit 440. The displaceable member 812 defines a push-pull function of the latching mechanism 871, whereby when the displaceable member 812 is displaced toward the hub 841, the pad connector 811 can be separated from the hub 841 by pulling on the pad connector 811. Corresponding components and structures within the pad connector 811 and the hub 841 define an overlapping (or interference) engagement between a portion of the pad connector 811 and a portion of the hub 841, where the engagement prevents displacement of the pad connector 811 relative to the hub 841 to separate. In use, to disconnect the pad connector 811 from the hub 841, a clinician can push the displaceable member 812 towards the hub 841 to release the latch mechanism 871 and then separate the pad connector 811 from the hub 841 by pulling on the housing of the pad connector 811. To connect the pad connector 811 to the hub 841, a clinician can push the displaceable member 812 towards the housing of the pad connector 811 to actuate the latch mechanism 871 and then displace the pad connector 811 towards the hub 841. In some embodiments of use, a clinician can push the displaceable member 812 towards the hub 841 to release the latch mechanism 871 and displace the pad connector 811 towards the hub 841 in a single step.
[0090] 8B shows a latch mechanism 872 that secures the pad connector 813 to the hub 842. The pad connector 813 includes a displaceable (or deflectable) member 814 pivotally mounted to a connector housing 813A of the pad connector 813. The displaceable member 814 defines a lateral displacement function of the latch mechanism 871, i.e., the displaceable member 814 moves substantially perpendicular to the displacement direction of the pad connector 813 when connecting and disconnecting the pad connector 813 to the hub 842. The displaceable member 814 is coupled to the connector housing 813A via a bendable hinge portion of the displaceable member 814 such that the bendable hinge portion bends when the displaceable member 814 is displaced toward the connector housing 813A. The displaceable member 814 and corresponding structure of the hub define an overlapping (or interference) engagement between a portion of the displaceable member 814 and a portion of the hub 841 during use. To connect the pad connector 811 to the hub 842, the clinician displaces the displaceable member 814 towards the connector housing 813A and then connects the pad connector 811 to the hub 842, thereby establishing a fluid connection. Once connected, the clinician causes the displaceable member 814 to self-deflect away from the connector housing 813A, such that portions of the displaceable member 814 and portions of the hub 842 overlap and engage, securing the pad connector 813 to the hub 842. To disconnect the pad connector 811 from the hub 842, the clinician displaces the displaceable member 814 towards the connector housing 813A to release the overlapping engagement, thereby allowing the pad connector 811 to be separated from the hub 842.
[0091] FIG. 8C illustrates a pad-hub latch mechanism 873 that secures the pad connector 815 to the hub 843. The hub 843 includes a displaceable member, such as a button 816. Corresponding components and structures of the pad connector 815 and the hub 843 establish an overlapping (or interference) engagement between a portion of the pad connector 815 and a portion of the hub 842 to define the latch mechanism 873. In use, to disconnect the pad connector 815 from the hub 843, the clinician depresses the button to release the latch mechanism 873, i.e., disengage the overlapping portion. The clinician can then separate the pad connector 815 from the hub 843. To connect the pad connector 815 to the hub 843, the clinician depresses the button 816 to release the latch mechanism 873 and then connects the pad connector 815 to the hub 843, thereby establishing a fluid connection. Once connected, the clinician releases the button 816 to actuate the latch mechanism 873.
[0092] 8D illustrates a pad-hub latching mechanism 874 in which the pad connector 817 includes a displaceable shroud 818. Corresponding components and structures of the pad connector 817 and hub 844 establish an overlapping (or interference) engagement between an interior portion of the pad connector 817 and one or more protrusions 895 extending away from the hub 844 to define the latching mechanism 874. The latching mechanism 874 is configured such that displacing the shroud 818 away from the hub 844 (as indicated by the arrow on the shroud 818 in FIG. 8D) against a biasing force (not shown) releases the latching mechanism 874 and activates the latching mechanism 874 when the shroud 818 is displaced away from the hub 844 (as indicated by the arrow on the shroud 818 in FIG. 8D) and allows the biasing force to automatically displace the shroud 818 towards the hub 844. In use, a clinician can grasp the fluid conduit 440 with one or more of the middle finger, ring finger, and pinky finger of one hand and simultaneously grasp the shroud 818 with the thumb and index finger of the same hand to displace the shroud 818 distally. To disconnect the pad connector 817 from the hub 844, the clinician can displace the shroud 818 to release the latch mechanism 874 and then separate the pad connector 817 from the hub 844. To connect the pad connector 817 to the hub 844, the clinician can displace the shroud 818 and then connect the pad connector 817 to the hub 844. In some embodiments, the latch mechanism 874 may be configured to automatically release during connection of the pad connector 817 to the hub 844, thereby facilitating a single-step connection.
[0093] 8E-8G show the pad-hub latch mechanism 875. FIG. 8E shows the pad connector 819 separated from the hub 845, FIG. 8F shows the pad connector 819 partially engaged with the hub 845, and FIG. 8G shows the pad connector 819 and hub 845 in a fully latched position. As shown in FIG. 8E, the hub 845 is configured to receive the pad connector 819 in a slot 845C. FIG. 8E shows that the pad connector 819 is inserted into the slot 845C with the pad connector 819 disposed at an angle 846 relative to the hub 845, allowing the curved end 819A of the pad connector 819 to fit within the jaw 845A of the hub 845. Once the curved end 819A is seated within the jaws 845A, the pad connector 819 is rotated until it is oriented parallel to the hub 845 to lock the curved end 819A within the jaws 845A, as shown in FIG. 8G. The pad connector 819 and hub 845 further include corresponding teeth 819B and 845B, respectively, that engage with one another when the pad connector 819 is oriented parallel to the hub 845 to fully latch the pad connector 819 to the hub 845. When the pad connector 819 is connected to the hub 845, the flow of the TTM fluid 112 is facilitated from the FDL 130 through the hub 845 and the pad connector 819 to the fluid conduit 440. In use, to connect the pad connector 819 to the hub 845, the clinician orients the pad connector 819 at an angle 846 and then inserts the pad connector 819 into the slot 845C until the curved end 819A engages the jaw 845A. The clinician then rotates the pad connector 819 to the fully latched position. To disconnect the pad connector 819 from the hub 845, the clinician rotates the pad connector back to angle 846 and then disconnects the pad connector 819 from the hub 845.
[0094] 9A-9D show various views of the module-FDL connection adapter 150. FIG. 9A shows an exploded view of the module-FDL connection adapter 150. The connection adapter 150 is configured to be attached to the TTM module 110 at a customer location, such as a medical facility. The connection adapter 150 is further configured to convert a module connector 15 (FIG. 1A) compatible with the FDL 13 to an adapter connector 932 compatible with the proximal FDL connector 532 of the FDL 130. The connection adapter 150 includes an input connector 911 compatible with the module connector 15. In use, the connection adapter 150 is attached to the TTM module 110 to replace the module connector 15.
[0095] The connection adapter 150 is dual lumen including a fluid delivery lumen 903 that extends from the input connector 911 to the adapter connector 932 and a fluid return lumen 904 that also extends from the input connector 911 to the adapter connector 932. In the illustrated embodiment, the adapter connector 932 defines a male connecting portion and the proximal FDL connector 532 defines a female connecting portion. In other embodiments, the adapter connector 932 may define a female connecting portion and the proximal FDL connector 532 may define a male connecting portion.
[0096] The connection adapter 150 defines a housing 910 that includes a hollow cylindrical portion 912. The housing 910 can enclose various components, as further described below. The connection adapter 150 further includes an adapter connector 932 and a rotatable member 920 that includes a cylindrical barrel portion 921. The cylindrical portion 912 is configured to receive the barrel portion 921 such that the barrel portion 921 is rotatable within the cylindrical portion 912. In some embodiments, the cylindrical portion 912 can include two or more portions of a cylindrical wall 912A that are coupled together. In such embodiments, assembly of the connection adapter 150 can include placing the barrel portion 921 between the sections of the cylindrical wall 912A and then coupling the sections of the cylindrical wall 912A together. In such embodiments, the sections of the cylindrical wall 912A can be screwed, glued, or snapped together.
[0097] The cylindrical portion 912 includes a slot 913 extending through the cylindrical wall 912A. The adapter connector 932 extends laterally away from the barrel portion 921 in a direction perpendicular to the barrel portion 921. The width of the slot 913 is sized to facilitate placement of the adapter connector 932 therethrough. The slot 913 extends along the circumference of the cylindrical portion 912 defining a length of the slot 913 sufficient to accommodate rotation of the barrel portion 921 through an angle of approximately 90 degrees while the adapter connector 932 is placed therethrough. The slot 913 is positioned on the cylindrical portion 912 such that the barrel portion 921 can rotate from a first angular position to a second angular position. In the first angular position, the adapter connector 932 is disposed in a substantially horizontal orientation as shown in FIG. 9A. In the second angular position, the adapter connector 932 is instead positioned in a substantially downward vertical orientation, as shown in FIG. 9B, which shows the connection adapter 150 assembled to be coupled to the base-end FDL connector 532 with the barrel portion 921 positioned in the second angular position.
[0098] 9A , the connection adapter 150 can include a retaining ring 926. The retaining ring 926 is disposed within the recess 916 such that when the barrel portion 921 is received within the cylindrical portion 912, the retaining ring 926 is sandwiched between the barrel portion 921 and the cylindrical wall 912A, and such that the retaining ring 926 rotates with the barrel portion 921. The retaining ring 926 can be formed of a material having spring-like properties, such as, for example, spring steel. The retaining ring 926 can be formed to define a frictional force between the barrel portion 921 and the cylindrical portion 912 to prevent rotation of the barrel portion 921 relative to the cylindrical portion 912 in the absence of a rotational force intentionally applied by the clinician. The retaining ring 926 can also include a recess or pin 927A configured to engage with a hole 927B in the cylindrical wall 912A when the barrel portion 921 is disposed in the first angular position, which engagement can provide a rotational stop that further prevents rotation of the barrel portion 921 away from the first angular position in the absence of a rotational force intentionally applied by the clinician.
[0099] The connection adapter 150 can be configured to provide a clinician with a visual indication regarding the angular position of the barrel portion 921 relative to the cylindrical portion 912. The barrel portion 921 can include one or more visual markers 923A shaped and positioned to be visible through one or more corresponding visual openings 923B through the cylindrical wall 912A. In some embodiments, the one or more visual markers 923A can include colored portions. For example, the one or more visual markers 923A can include a first colored portion (e.g., red) that is visible through the one or more visual openings 923B when the barrel portion 921 is disposed in a first angular position, and the one or more visual markers 923A can include a second colored portion (e.g., green) that is visible through the one or more visual openings 923B when the barrel portion 921 is disposed in a second angular position.
[0100] The connecting adapter 150 can include a latching mechanism that secures the proximal FDL connector 532 to the adapter connector 932. The latching mechanism can include corresponding features of the proximal FDL connector 532 and the connecting adapter 150. In the exemplary illustrated embodiment, the cylindrical wall 912A can include an extending wall portion 917 that projects into the slot 913, and the proximal FDL connector 532 can include a corresponding groove 947 sized and positioned to receive the extending wall portion 917. The extending wall portion 917 is positioned to engage the groove 947 when the barrel portion 921 is disposed in the second angular position, thereby preventing separation of the proximal FDL connector 532 from the adapter connector 932 when the barrel portion 921 is disposed in the second angular position.
[0101] In some embodiments, the extending wall portion 917 can be disposed in a plane (not shown) tangent to the cylindrical wall 912A, and the groove 947 can be an annular groove extending around the proximal FDL connector 532. In such embodiments, the extending wall portion 917 can engage with the groove 947 at any angular orientation of the proximal FDL connector 532 about its longitudinal axis.
[0102] 9A and 9B, the connection adapter 150 can include a locking mechanism 915, such as a clip. The locking mechanism 915 is configured to hold the barrel portion 921 in the second angular position when the proximal FDL connector 532 is coupled with the adapter connector 932. As shown in FIG. 9B, the locking mechanism 915 can include a clip that is biased to partially extend around the proximal FDL connector 532 to restrain the proximal FDL connector 532 in the second angular position in the absence of a rotational force applied by the clinician to bias the rotatable member 920 away from the second angular position. In other embodiments, the locking mechanism 915 can be configured to restrain the proximal FDL connector 532 in a vertically downward orientation in the absence of a non-rotational intentional action by the clinician, i.e., an intentional action independent of rotating the rotatable member 920, such as pressing a button or actuating a lever (not shown). In some embodiments, the connection adapter 150 can include a rotational biasing member (not shown), such as a torsion spring, configured to bias the rotatable member 920 to rotate toward the first angular position.
[0103] In use, prior to connecting the FDL 130 to the TTM module 110, the barrel portion 921 can be placed in a first angular position such that the adapter connector 932 extends horizontally away from the TTM module 110. A clinician can then connect the proximal FDL connector 532 to the adapter connect 932. The clinician can then grasp the proximal FDL connector 532 or the proximal portion of the FDL 130 and rotate the barrel portion 921 to a second angular position to actuate the latching mechanism and secure the proximal FDL connector 532 within the securing mechanism 915. At the end of the TTM treatment, the clinician can rotate the barrel portion 921 to the first angular position to release the latching mechanism and disconnect the proximal FDL connector 532 from the adapter connect 932.
[0104] 9A and 2, the connection adapter 150 can include a delivery valve 251 in line with the fluid delivery lumen 903 and a return valve 252 in line with the fluid return lumen 904. In the illustrated embodiment, the valves 251 and 252 are controllable electromechanical valves. In other embodiments, the valves 251 and 252 can be operated in response to a rotation of the barrel portion 921. For example, one or both of the valves 251 and 252 can close when the barrel portion 921 is disposed in a first angular position and then open when the barrel portion 921 is rotated to a second angular position. In yet other embodiments, the valves 251 and 252 can be incorporated into the adapter connector 932, such as the valves illustrated in the first delivery valve 731 and the first return valve 732 in FIG. 7A. The connection adapter 150 can include an electrical connector 919 coupled to the adapter console 350 via a wire 919A. The electrical connector 919 is coupled to the console 300 when the connection adapter 150 is attached to the TTM module 110 , thereby enabling the console 300 to supply power to the adapter console 350 .
[0105] 9C shows a cross-sectional top view of the connection adapter 150 taken along section line 9C-9C of FIG. 9B. As shown, the fluid delivery lumen 903 and the fluid return lumen 904 extend in a side-by-side arrangement through the input connector 911 and the housing 910 to the barrel portion 921. In the illustrated embodiment, the fluid delivery lumen 903 and the fluid return lumen 904 are changed from a side-by-side arrangement to a concentric arrangement within the barrel portion 921. In other embodiments, the fluid delivery lumen 903 and the fluid return lumen 904 may be changed from a side-by-side arrangement to a concentric arrangement within the housing 910. FIG. 9C also shows the delivery valve 251 in alignment with the delivery lumen 903 and the return valve 252 in alignment with the fluid return lumen 904.
[0106] 9D shows a block diagram illustrating various elements of the adapter console 350, including a power supply module 951, a valve driver 952, a controller 953, and an authentication module 957. The power supply module 951 receives power from the TTM module console 300 and provides power to the other elements of the adapter console 350. The valve driver 952 is configured to actuate the valves 251 and 252 individually or together according to the controller logic 956. In the illustrated embodiment, the adapter console 350 may not be in signal communication with the console 300 of the TTM module 110.
[0107] The authentication module 957 is configured to receive or otherwise obtain authentication data from an authentication tag. In some embodiments, the authentication module 957 may be an RFID reader. The authentication module 957 provides the authentication data obtained from one or more authentication tags, such as the FDL authentication tag 557, the hub authentication tag 547, or the pad authentication tag 457, to the controller logic 956 of the controller 953, which can cause the processor 954 to perform various operations in accordance with the controller logic 956.
[0108] In some embodiments, the authentication information may include manufacturing information, such as a manufacturing date range or a lot number. In some embodiments, any of the authentication tags 457, 547, and 557 may provide data in a wired or wireless manner. For example, any of the authentication tags 457, 547, and 557 may be an RFID tag. In other embodiments, any of the authentication tags may query a circuit, which provides the authentication information in a wireless manner (e.g., via a radio transmitter) or in a wired manner, such as via a data cable. In some embodiments, the connection adapter 150 may obtain power from the console, thereby providing power to any of the authentication tags. For example, power may be provided to the authentication tag 457 or 557 via wiring 535 in the proximal FDL connector 532 and the distal FDL connector 533, which are coupled to the FDL conduit 531. Thus, when a connection is established between the connection adapter 150, the FDL 130, and the connector containing the authentication tag, the authentication tag receives power and, in response, transmits authentication back to the connection adapter 150 via a wireless transmitter included in the circuit or via the wire 535 over which power was received. In one embodiment, a form of authenticated encryption and associated data (AEAD) using a challenge-response technique may be utilized when exchanging data between the connection adapter 150 and the authentication tag 457, 547, or 557.
[0109] In some embodiments, the controller logic 956 can be configured to compare the authentication data obtained from any or all of the authentication tags 457, 547, and 557 to authentication information stored in the memory 955, which includes a non-transitory computer readable medium. For example, the controller logic 956 can compare the FDL identification data obtained from the FDL authentication tag 557 to the approved FDL identification information stored in the memory 955. As a result of the comparison, the controller logic 956 can prevent the opening of one or both of the valves 251 and 252 if the FDL identification data obtained from the FDL authentication tag 557 does not match the approved FDL identification information stored in the memory 955. Thus, in the illustrated embodiment, the connection adapter 150 can enable or disable the circulation of the TTM fluid 112 between the TTM module 110 and the pad set 120 independent of the fluid flow control logic 343 of the console 300.
[0110] In other embodiments, the console 300 of the TTM module 110 can be in signal communication with the adapter console 350. In such embodiments, one or more of the patient treatment logic 341, the fluid temperature control logic 342, and / or the fluid flow control logic 343 can cause the processor 310 to perform one or more actions according to authentication data obtained by the authentication module 957 from one or more authentication tags attached to the FDL 130, the hub 140, or any thermal pads of the pad set 120.
[0111] In some embodiments, the authentication tag 457, 547, or 557 can be configured to receive and store information, such as treatment information. Such treatment information can include date, time, duration of treatment, number of connections, number of thermal pads, TTM temperature, TTM flow rate, and any other treatment or usage information as may be contemplated by one of skill in the art. In such embodiments, the operation of the TTM module 110 can be altered according to information stored in the memory of one or more of the authentication tags 457, 547, and 557 (e.g., treatment information as described above).
[0112] 10A-10C show a manifold hub 1040 having one or more distal hub connectors 1041 arranged in a line parallel to the longitudinal axis of the hub 1040. In some embodiments, the hub 1040 can include one or more distal hub connectors 1041. Each of the one or more distal hub connectors 1041 is configured to connect to a corresponding pad connector 471 of the pad set 120 (FIG. 1B). It is noted that the pad connectors 471 can be shaped differently, for example, as seen in FIGS. 4A, 10A, and 11A. The hub 1040 also includes a proximal hub connector 1043 configured to connect to a distal FDL connector 533 of the FDL 130 (FIG. 5A). The hub 1040 can include a mounting member 1045 attached to the hub 1040 at its rear side. The attachment member 1045 may include one or more patches of hook-and-loop fastener, commonly referred to as Velcro. As shown in Figure 10B, the hub 1040 may be attached to an external device such as a bed, a bed rail, or the like.
[0113] 10C, the attachment member 1045 can be attached to a thermal pad of the pad set 120. For example, a corresponding portion of a hook-and-loop fastener can be attached to the thermal pad, thereby attaching the hub 1040 to the thermal pad.
[0114] 11A-11E show a hub 1140 having multiple distal hub connectors 1141 disposed along the circumference of the hub 1140. As shown in FIG. 11A, the hub 1140 can include up to six or more distal hub connectors 1141. Each distal hub connector of the distal hub connectors 1141 is configured to connect to a corresponding pad connector 471 of the pad set 120. The hub 1140 also includes a proximal hub connector 1143 configured to connect to a distal FDL connector 533 of the FDL 130 (FIG. 5A).
[0115] The hub 1140 can include an attachment member 1145 attached to the hub 1140 at a rear side thereof. The attachment member 1145 can include one or more patches of a first portion of a hook-and-loop fastener, such as a VELCRO brand hook-and-loop fastener. As shown in FIG. 11B, the hub 1140 can be placed on a surface of the bed 60 such that the attachment member 1145 couples with the bed surface.
[0116] 11C, one or more thermal pads of pad set 120 can include a portion such as a band 1147 to which a corresponding second portion of hook-and-loop fastener 1146 is attached. In use, a clinician can couple hub 1140 to a thermal pad via attachment member 1145 and the corresponding fastener of band 1147.
[0117] 11D shows a hub 1140 that includes an add-on clip 1142. As shown in FIG. 11E, the clip 1142 can be configured to be attached to an external device, such as a bed rail 61. In some embodiments, the clip 1142 can be detachable from the hub 1140.
[0118] 12 illustrates a TTM system 1200 including a TTM module 1210 and a pad set 1220. The TTM module 1210 includes a connection panel 1216 having a plurality of dual lumen module connectors 1215. Each thermal pad of the pad set 1220 includes a dual lumen fluid conduit 1240 that extends continuously from the pad portion 1205 to the TTM module 1210. The fluid conduit 1240 includes a dual lumen fluid conduit connector 1271 at a proximal end. The fluid conduit connector 1271 is configured to couple with the module connector 1215. In some embodiments, the pad set 1220 can include up to six or more thermal pads and the connection panel 1216 can correspondingly include up to six or more module connectors 1215. Any and all portions of the dual lumen connection system 700 can be employed in the TTM system 1200 to define a fluid connection between any two fluid connection entities, such as between any of the multiple module connectors 1215 and any fluid conduit connector 1271.
[0119] Without further elaboration, it is believed that one skilled in the art can utilize the present invention to its fullest extent using the preceding description. The claims and embodiments disclosed herein are merely illustrative and exemplary and should not be construed as limiting the scope of the present disclosure in any way. It will be apparent to one skilled in the art that, with the aid of this disclosure, changes can be made to the details of the above embodiments without departing from the basic principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the above description are within the scope of the appended claims. Furthermore, the order of steps or operations of the methods disclosed herein may be changed by one skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or operations is necessary for the proper operation of the embodiment, the order or use of specific steps or operations may be changed. The scope of the present invention is therefore defined by the following claims and their equivalents.
Claims
1. A fluid delivery line (FDL) used to transport TTM fluid between a targeted temperature management (TTM) module and one or more thermal contact pads applied to a patient, a proximal FDL connector at a proximal end of the FDL and configured to connect with the TTM module; An FDL conduit, a fluid delivery lumen; a fluid return lumen in parallel arrangement with said fluid delivery lumen; a branch of the FDL conduit defining a pair of FDL legs; an FDL comprising: a pair of tip manifold hubs respectively coupled to the pair of FDL legs at a tip of the FDL, each tip manifold hub including one or more tip hub connectors configured to connect to one or more pad connectors of the one or more thermal contact pads, respectively, each tip hub connector of the one or more tip hub connectors including a displaceable member configured to engage or disengage a pad-hub latch mechanism to secure or release a corresponding one of the one or more pad connectors relative to the tip hub connector, respectively.
2. The FDL of claim 1 further comprising wiring extending along a length of the FDL.
3. The FDL of claim 1 or 2, wherein the proximal FDL connector is configured to fluidly, mechanically, and electrically connect with the TTM module.
4. The FDL of claim 1 or 2, wherein the one or more distal hub connectors are configured to fluidly, mechanically, and electrically connect with the one or more pad connectors, respectively.
5. The FDL of claim 1 or 2, wherein the displaceable member is a button.
6. 6. The FDL of claim 5, wherein the button is configured to disengage the pad-hub latch mechanism when pressed, thereby allowing the corresponding pad connector of the one or more pad connectors to be released from the distal hub connector of the one or more distal hub connectors.
7. 6. The FDL of claim 5, wherein the button is configured to, when pressed, disengage the pad-hub latch mechanism, thereby allowing the corresponding pad connector of the one or more pad connectors to be secured to the distal hub connector of the one or more distal hub connectors.
8. 3. The FDL of claim 1 or 2, wherein each distal hub connector of the one or more distal hub connectors includes a sealing member configured to define a seal with a valve of the corresponding pad connector of the one or more pad connectors when the corresponding pad connector is secured to the distal hub connector.
9. 9. The FDL of claim 8, wherein the valve of a corresponding one of the one or more pad connectors is biased toward a closed state such that the valve automatically closes when the corresponding pad connector is disconnected from the distal hub connector.
10. A fluid delivery line (FDL) used to transport TTM fluid between a targeted temperature management (TTM) module and a thermal contact pad applied to a patient, a dual lumen fluid conduit extending from a proximal end to a distal end; a dual lumen proximal FDL connector at the proximal end, the dual lumen proximal FDL connector is configured to couple with the TTM module; a dual lumen proximal FDL connector, the two lumens of which are concentrically arranged; a dual lumen distal connector at the distal end and configured to couple to a manifold hub, the dual lumen distal connector including a pair of valves, each valve aligned with a separate one of the two lumens, each valve comprising: automatically preventing fluid flow through each of the lumens of the dual lumen distal connector when the dual lumen distal connector is disconnected from the manifold hub; The FDL is configured to automatically permit fluid flow through its respective lumen when the dual lumen distal connector is coupled to the manifold hub.
11. 11. The FDL of claim 10, wherein the dual lumen distal connector comprises a latch mechanism having a displaceable member, which when the displaceable member is in a displaced state allows the dual lumen distal connector to be pulled away from the manifold hub and which when the displaceable member is in a non-displaced state prevents the dual lumen distal connector from being pulled away from the manifold hub.
12. The FDL of claim 10 , wherein the two lumens of the dual lumen distal connector are concentrically arranged.
13. When coupled to the dual lumen distal connector, the dual lumen proximal FDL connector comprises: Connect to the module connector of the TTM module; The FDL of claim 10 , configured to pivot from a first position in which the longitudinal axis is oriented substantially horizontally to a second position in which the longitudinal axis is oriented substantially vertically.
14. the dual lumen proximal FDL connector is configured to latch to the TTM module; When the dual lumen proximal FDL connector is oriented horizontally, a latching mechanism is released, allowing separation of the dual lumen proximal FDL connector from an adapter; 14. The FDL of claim 13, wherein the latch mechanism is activated when the dual lumen proximal FDL connector is oriented vertically, preventing separation of the dual lumen proximal FDL connector from the adapter.
15. The dual lumen proximal FDL connector comprises a pair of proximal valves, each proximal valve aligned with a different one of the two lumens of the dual lumen proximal FDL connector, each proximal valve comprising: automatically preventing fluid flow through each of the lumens of the dual lumen proximal FDL connector when the dual lumen proximal FDL connector is disconnected from the TTM module; The FDL of claim 10 , wherein the dual lumen proximal FDL connector is configured to automatically allow fluid flow through its respective lumens when coupled with the TTM module.
16. The FDL of claim 10 further comprising an authentication tag configured to provide FDL authentication data to the TTM module.
17. The FDL of claim 10 , wherein the FDL is coupled to the manifold hub, the manifold hub comprising a plurality of dual lumen distal hub connectors configured to couple to a plurality of thermal contact pads.
18. 11. The FDL of claim 10, wherein the FDL is coupled to two or more manifold hubs, each manifold hub comprising a plurality of dual lumen distal hub connectors configured to couple to a plurality of thermal contact pads.
19. The FDL of claim 10 , wherein the two lumens of the dual lumen fluid conduit are concentrically disposed along at least a portion of the dual lumen fluid conduit.
20. 1. A thermal contact pad assembly for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient, comprising: A thermal contact pad comprising: a pad portion configured to be placed on the patient; a dual lumen fluid conduit extending proximally away from said pad portion; a dual lumen pad connector connected at a proximal end to the dual lumen fluid conduit; A manifold hub comprising: Housing and a dual lumen distal hub connector coupled to the dual lumen pad connector; a dual lumen proximal hub connector configured to couple with a dual lumen fluid delivery line (FDL) of the TTM system; the TTM fluid flows through the housing between flowing through the dual lumen distal hub connector and flowing through the dual lumen proximal hub connector; The dual lumen proximal hub connector includes two lumens arranged in a concentric arrangement. A thermal contact pad assembly.
21. The dual lumen proximal hub connector includes a pair of valves, each valve aligned with a different one of the two lumens, each valve comprising: when said dual lumen proximal hub connector is disconnected from said dual lumen FDL, said dual lumen FDL automatically prevents fluid flow through its respective lumen; 21. The assembly of claim 20, wherein said dual lumen proximal hub connector is configured to automatically permit fluid flow through its respective lumens when coupled with said dual lumen FDL.
22. the dual lumen proximal hub connector is configured to couple with the dual lumen FDL via a proximal latch mechanism, the proximal latch mechanism including a displaceable member; When the displaceable member is in a displaced state, the dual lumen proximal hub connector can be pulled away from the dual lumen FDL; 21. The assembly of claim 20, wherein when the displaceable member is in a non-displaced state, pulling the dual lumen proximal hub connector away from the dual lumen FDL is prevented.
23. Each dual lumen distal hub connector in combination with a corresponding dual lumen pad connector includes a distal latch mechanism; At least one of the dual lumen distal hub connector or the dual lumen pad connector includes a displaceable member of the distal latch mechanism; when the displaceable member of the distal latch mechanism is in a displaced state, the dual lumen pad connector is permitted to be pulled away from the dual lumen distal hub connector; 21. The assembly of claim 20, wherein when the displaceable member of the distal latch mechanism is in a non-displaced state, pulling the dual lumen pad connector away from the dual lumen distal hub connector is prevented.
24. the manifold hub comprises a plurality of said dual lumen distal hub connectors, each dual lumen distal hub connector configured to mate with a dual lumen pad connector; Each dual lumen distal hub connector includes a pair of valves; each valve of the pair of valves is aligned with a different one of the two lumens; Each valve of the pair of valves is automatically preventing fluid flow through its respective lumen when the dual lumen distal hub connector is disconnected from the dual lumen pad connector; 21. The assembly of claim 20, wherein the dual lumen distal hub connector is configured to automatically permit fluid flow through its respective lumens when coupled with the dual lumen pad connector.
25. 21. The assembly of claim 20, wherein the two lumens of the dual lumen distal hub connector are concentrically disposed.
26. 21. The assembly of claim 20, further comprising a plurality of thermal contact pads coupled to said manifold hub via a plurality of said dual lumen distal hub connectors.
27. 21. The assembly of claim 20, further comprising an authentication tag attached to at least one of the thermal contact pad or the manifold hub, the authentication tag configured to provide authentication data to a TTM module of the TTM system.
28. 21. The assembly of claim 20, wherein the manifold hub comprises a mounting device configured to couple the manifold hub to at least one of the thermal contact pad, a bed surface, or a bed rail.
29. 1. A targeted temperature management (TTM) system, comprising: a TTM module configured to supply a TTM fluid; a thermal pad configured to facilitate thermal energy transfer between the TTM fluid and a patient, a pad portion configured to be placed on the patient; a dual lumen fluid conduit extending proximally away from said pad portion; a dual lumen fluid delivery line (FDL) configured to transport a TTM fluid between the TTM module and the thermal pad, the dual lumen FDL including a proximal dual lumen FDL connector at a proximal end of the dual lumen FDL and a distal dual lumen FDL connector at a distal end of the dual lumen FDL; a manifold hub coupled to the dual lumen FDL at the distal end of the dual lumen FDL, the manifold hub configured to facilitate a dual lumen fluid connection between the dual lumen FDL and the dual lumen fluid conduit, and coupling the dual lumen FDL to the TTM module includes: coupling the proximal dual lumen FDL connector, including the two concentric lumens of the dual lumen FDL, to a dual lumen module connector of the TTM module; and opening a pair of valves of the TTM module, each valve being aligned with a separate one of the two lumens of the dual lumen module connector, to enable bidirectional flow of the TTM fluid through the dual lumen module connector.
30. 30. The system of claim 29, further comprising a connection adapter attached to the TTM module, the connection adapter comprising the pair of valves and the dual lumen module connector.
31. 31. The system of claim 30, wherein the connection adapter comprises an adapter console including a controller having a processor and controller logic stored in a memory, the controller logic configured to selectively open and close the pair of valves.
32. 32. The system of claim 31, wherein the adapter console comprises an authentication module configured to obtain authentication data from an authentication tag attached to at least one of the dual lumen FDL, the manifold hub, or the thermal pad.
33. 33. The system of claim 32, wherein the controller logic is configured to open the pair of valves if the obtained authentication data matches authentication information stored in a memory.
34. 31. The system of claim 30, wherein the connection adaptor comprises a latching mechanism configured to secure the proximal dual lumen FDL connector to the connection adaptor.
35. the latch mechanism comprises a pivot member coupled to the proximal dual lumen FDL connector such that the proximal dual lumen FDL connector is rotatable between a horizontal orientation and a vertical orientation; When the proximal dual lumen FDL connector is oriented horizontally, the latch mechanism is released, allowing the proximal dual lumen FDL connector to be separated from the connection adapter; 35. The system of claim 34, wherein the latch mechanism is activated when the proximal dual lumen FDL connector is oriented vertically, preventing separation of the proximal dual lumen FDL connector from the connection adapter.
36. 36. The system of claim 35, wherein the latching mechanism includes a clip configured to engage the proximal dual lumen FDL connector, thereby vertically restraining the proximal dual lumen FDL connector.
37. The manifold hub is connected to the dual lumen FDL via a dual lumen proximal hub connector having a pair of hub valves, each hub valve aligned with a different one of the two lumens of the dual lumen proximal hub connector, each hub valve being: when said dual lumen proximal hub connector is disconnected from said dual lumen FDL, said dual lumen FDL automatically prevents fluid flow through its respective lumen; 30. The system of claim 29, wherein said dual lumen proximal hub connector is configured to automatically permit fluid flow through its respective lumens when coupled with said dual lumen FDL.
38. the dual lumen proximal hub connector is configured to couple with the dual lumen FDL via a proximal latch mechanism, the proximal latch mechanism including a displaceable member; When the displaceable member is in a displaced state, the dual lumen proximal hub connector can be pulled away from the dual lumen FDL; 38. The system of claim 37, wherein when the displaceable member is in a non-displaced state, pulling the dual lumen proximal hub connector away from the dual lumen FDL is prevented.