阅读说明：本技术 用于连接热交换器与血管内温度管理导管的具有铰链式室或壳体的工作流体盒 (Working fluid cartridge with hinged chamber or housing for connecting a heat exchanger to an intravascular temperature management catheter ) 是由 C·P·帕米切夫 J·T·德布罗维克 于 2016-03-30 设计创作，主要内容包括：支撑有环状泵管(44)的壳体或室(50)铰接至有框的薄壁热交换袋(54),其中来自血管内热交换导管(12)的工作流体流动通过该袋(54)。具有袋的框能够插入冷板(31)之间以与流过袋的工作流体交换热量。在有框的袋位于冷板之间的情况下,来自壳体或室的环状泵管(44)可接收于蠕动泵(30)的轨道(32)中,该蠕动泵(32)将工作流体泵送通过系统。(A housing or chamber (50) supporting an annular pump tube (44) is hinged to a framed, thin-walled heat exchange bag (54), wherein working fluid from an intravascular heat exchange catheter (12) flows through the bag (54). The frame with the bag can be inserted between cold plates (31) to exchange heat with the working fluid flowing through the bag. With the framed bag between the cold plates, a ring of pump tubing (44) from the housing or chamber may be received in a track (32) of a peristaltic pump (30), the peristaltic pump (32) pumping the working fluid through the system.)

1. An apparatus, comprising:

a housing in which a pump tube is disposed;

an assembly comprising a heat exchange bag connected to the housing for holding an operating fluid from an intravascular heat exchange catheter or an external heat exchange pad, the heat exchange bag configured to be inserted into a heat exchanger for heat exchange between the heat exchanger and the operating fluid flowing through the bag, wherein the pump tube from the housing is receivable in a peristaltic pump when the heat exchange bag is disposed in the heat exchanger, wherein the operating fluid from the intravascular heat exchange catheter or external heat exchange pad passes through an inlet tube to enter the heat exchange bag; and

a damper tube in fluid communication with the pump tube to receive working fluid from the pump tube, the damper tube configured to damp pulses in working fluid from the intravascular heat exchange catheter or external heat exchange pad.

2. The device of claim 1, wherein the housing is hinged to the assembly for movement between a shipping position in which an open bottom side of the housing is parallel to the assembly and closely spaced from the pouch, and an operating position in which the open bottom side is perpendicular to the assembly.

3. The device of claim 1, comprising a reservoir in the housing for receiving working fluid from the bag.

4. The device of claim 1, wherein the pump tube is in fluid communication with a reservoir in the housing to receive working fluid from the reservoir.

5. The apparatus of claim 1, further comprising a drain tube extending to a track of the assembly that is pulled a distance away from the inlet tube, the drain tube being useful for evacuating the bag by reversing the pump to withdraw working fluid from the bag through the drain tube.

6. The device of claim 5, wherein the damper tube is configured with more than one pulse damping ring.

7. The device of claim 1, comprising a supply tube in fluid communication with the damper tube to deliver working fluid to an intravascular heat exchange catheter or an external heat exchange pad.

8. A device according to claim 3, wherein the reservoir is in fluid communication with a source of IV fluid via a single IV line, and the device provides a closed fluid loop in which liquid and air flow in opposite directions through the IV or other line.

9. The apparatus of claim 1, wherein the heat exchanger comprises heat exchange plates, the pouch being configured to be received between the heat exchange plates to enable heat to be exchanged between a working fluid flowing through the pouch and at least one of the heat exchange plates.

10. An apparatus, comprising:

a bag supported by the frame, the bag having the frame receivable in a heat exchanger; and

a chamber supporting a conduit in fluid communication with the bag, the conduit configured to engage a pump to enable the pump to apply a force to the conduit to circulate a working fluid, the working fluid from a heat exchange element being able to pass through an inlet tube in a first rail of the frame to enter the bag; the inlet tube having a first diameter and terminating proximate the first rail such that working fluid enters the bag proximate the first rail; and the device further comprising a drain tube extending towards a second rail of the frame, the second rail being opposite and parallel to the first rail, the drain tube terminating adjacent the second rail, the drain tube being useful for emptying the bag, the chamber being movably connected to the frame by reversing the pump to withdraw working fluid from the bag through the drain tube.

11. The apparatus of claim 10, wherein the heat exchanger comprises heat exchange plates, the pouch being configured to be received between the heat exchange plates to enable heat to be exchanged between a working fluid flowing through the pouch and at least one of the heat exchange plates.

12. The device of claim 10, wherein the chamber is hinged to the frame.

13. The device of claim 10, wherein the chamber is connected to the frame for movement between a shipping position in which an open bottom side of the chamber is approximately parallel to the frame and closely spaced from the bag and an operating position in which the open bottom side is at an angle to the frame.

14. The apparatus of claim 10, comprising a return tube configured to carry working fluid from an intravascular heat exchange catheter or an external heat exchange pad to the bag.

15. The device of claim 14, comprising a reservoir in the chamber to receive working fluid from the bag.

16. The apparatus of claim 15, wherein the conduit receives working fluid from the reservoir.

17. The device of claim 10, comprising a damper tube in fluid communication with the conduit to receive working fluid from the conduit, the damper tube configured to dampen pulses in the working fluid.

18. The device of claim 17, wherein the damper tube is configured with more than one damping ring.

19. The device of claim 17, comprising a supply tube in fluid communication with the damper tube to deliver working fluid to an intravascular heat exchange catheter or an external heat exchange pad.

20. The apparatus of claim 10, wherein the drain tube extends through the inlet tube.

21. The device of claim 15, wherein the reservoir is in fluid communication with an IV fluid source via a single IV line, and the device provides a closed fluid loop in which liquid and air flow in opposite directions through the IV line.

22. The device of claim 10, wherein the tube is looped and receivable in a track of a peristaltic pump.

23. A method of exchanging heat for non-therapeutic purposes, comprising:

obtaining a framed heat exchange bag for holding working fluid from an intravascular heat exchange catheter or an external heat exchange pad, the heat exchange bag depending downwardly from a housing, wherein the housing is connected to the frame of the framed heat exchange bag for movement between a transport position in which a bottom side of the housing is parallel to the frame and closely spaced from the bag and an operative position in which the bottom side is at an angle to the frame;

engaging a loop of pump tubing supported by the housing with a track of the peristaltic pump; and is

The heat exchange bag is arranged between opposite plates of the heat exchanger when the housing is in the operating position.

Technical Field

The present application relates generally to heat exchange systems for patient temperature control having a working fluid cartridge.

Background

Patient temperature control systems have been introduced to prevent patients in a neurological intensive care unit from becoming febrile due to subarachnoid hemorrhage or other neurological diseases such as stroke. In addition, the system has been used to induce mild or moderate hypothermia to improve the therapeutic efficacy of patients suffering from diseases such as stroke, cardiac arrest, myocardial infarction, traumatic brain injury, and high intracranial pressure. Examples of intravascular heat exchange catheters are disclosed in the following U.S. patents: no.7,914,564, No.6,416,533, No.6,409,747, No.6,405,080, No.6,393,320, No.6,368,304no.6,338,727, No.6,299,599, No.6,290,717, No.6,287,326, No.6,165,207, No.6,149,670, No.6,146,411, No.6,126,684, No.6,306,161, and No.6,306,161, all incorporated herein by way of incorporation.

An external patient temperature control system may be used. Such systems are disclosed in the following U.S. patent applications: no.6,827,728, No.6,818,012, No.6,802,855, No.6,799,063, No.6,764,391, No.6,692,518, No.6,669,715, No.6,660,027, No.6,648,905, No.6,645,232, No.6,620,187, No.6,461,379, No.6,375,674, No.6,197,045, and No.6,188,930 (collectively, "exterior gasket patents"), the entire contents of which are incorporated herein by reference.

Generally, in all intravascular and external patient temperature control schemes, the working fluid temperature flowing through the catheter or pad is regulated by a heat exchange console based on feedback provided by the patient's actual body temperature, typically the core body temperature may be various rectal, esophageal, tympanic, or the like blood temperatures, e.g., vena cava, or the like. The working fluid temperature is regulated by thermally coupling the working fluid to heating and/or cooling elements in the console. In many cases, the working fluid is pushed in a closed fluidic loop (including the console and the catheter or gasket) by a peristaltic pump acting on tubing in the fluidic loop, such as pump tubing or IV tubing.

Disclosure of Invention

As understood herein, it is desirable to provide a quick and easy way to interconnect an intravascular heat exchange catheter or external pad with a heat exchanger.

Accordingly, an apparatus having a thin-walled bag supported by a frame is provided. The framed pouch is receivable between the heat exchange plates such that heat can be exchanged between a working fluid flowing through the pouch and at least one of the heat exchange plates. A chamber (plenum) or housing is connected to the frame. The chamber or housing supports a pump tube in fluid communication with the bag. For example, an annular pump tube may be configured to engage a track or channel of the pump such that the pump may apply force to the pump tube to circulate the working fluid.

The chamber or housing may be hinged to the frame to move between a shipping position (shipping position) in which the open or closed bottom side of the chamber or housing is parallel to the frame and closely spaced from the bag, and an operating position (operating position) in which the bottom side is perpendicular to the frame. In some examples, the return tube is configured to carry working fluid from the intravascular heat exchange catheter or the external heat exchange pad to the bag.

If desired, there may be a reservoir in the chamber or housing, or the reservoir may be part of the chamber or housing, to receive the working fluid from the bag. In this example, the pump tube may receive the working fluid from the reservoir. Additionally, a damper or damper tube may be in fluid communication with the pump tube to receive the working fluid from the pump tube. The damper tube may be configured with more than one pulse damping ring. In addition, the supply tube may be in fluid communication with the damper tube to deliver the working fluid to an intravascular heat exchange catheter or an external heat exchange pad. In particular embodiments, the damper may be in a form other than a tube. The damper may be any impulse damper, for example, the damper may be a damper tube, damper or other device that absorbs shock caused by changing the direction or velocity of the fluid flow within the tube or absorbs other shock caused by the action of the pump.

In some examples, working fluid from the return tube passes through an inlet tube in the head rail of the frame to enter the bag. The inlet tube has a first diameter and terminates proximate the head rail such that the working fluid enters the bag proximate the head rail. The drain tube extends through the inlet tube toward a bottom rail of the frame opposite and parallel to the head rail, and the drain tube terminates near an opening of the bottom rail or remains proximate to the bottom rail. The drain tube may be used to evacuate the bag by reversing the pump to withdraw working fluid from the bag through the drain tube.

In another aspect, the apparatus includes a chamber or housing supporting an annular pump tube, and a framed, thin-walled heat exchange bag attached to the chamber or housing. The thin-walled heat exchange bag is for holding an operating fluid from an intravascular heat exchange catheter or external heat exchange pad and is configured to be interposed between opposing plates for heat exchange between the plates and the operating fluid flowing through the bag. When framed thin-walled heat exchange bags are between the plates, annular pump tubing from the chamber or housing can be received or placed in the track or channel of the peristaltic pump.

In another aspect, a method includes engaging a loop of pump tubing supported by a chamber or housing with a track or channel of a peristaltic pump, and disposing a heat exchange bag depending downwardly from the chamber or housing between opposing plates of a heat exchanger.

The details of the various embodiments described herein, both as to their structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:

drawings

FIG. 1 is a schematic diagram of a non-limiting system according to one embodiment;

FIG. 2 is an exploded perspective view of an example pump with a cassette;

FIG. 3 is a perspective view of an example cassette with the chamber in a transport position;

FIG. 4 is a perspective view of an example cartridge with the chamber in an operating position;

FIG. 5 is a perspective view of an example cassette with chambers hinged or rotated past an operating position;

FIG. 6 is a perspective view of the interior of the chamber as viewed from the bottom of the chamber when arranged for operation;

FIG. 7 is a perspective view of the pump assembly with the rotor in the loaded position;

FIG. 8 is a perspective view of the pump assembly with the rotor in the locked (operating) position;

FIG. 9 is a perspective view of the cassette showing the rotor of the pump assembly in a loading position;

FIG. 10 is a perspective view of the cassette showing the rotor of the pump assembly in a locked (operating) position; and is

Fig. 11 is a perspective view showing an example cassette embodiment for a drain tube of a thin-walled heat exchange bag with portions of the frame broken off (broken away) for clarity and the chamber removed for ease of disclosure.

Detailed Description

Referring first to fig. 1, in accordance with the present principles, a system 10 may include an intravascular heat exchange catheter 12 controlled by a control system 14 to control patient temperature, e.g., to prevent fever in a patient 16 or to induce therapeutic hypothermia in the patient. In the conduit, a working fluid or coolant, such as, but not limited to, saline or the like (typically affected by a pump "P" in the control system), circulates in a closed loop from the control system 14, through the fluid supply line L1, through the conduit 12, and back to the system 14 through the return line L2, such that no working fluid or coolant enters the body. Although certain preferred catheters are disclosed herein, it is to be understood that other catheters may be used in accordance with the present principles, including but not limited to any of the catheters disclosed above or disclosed in the following U.S. patents, the entire contents of which are incorporated herein by reference: USPN 6,419,643, 6,416,533, 6,409,747, 6,405,080, 6,393,320, 6,368,304, 6,338,727, 6,299,599, 6,290,717, 6,287,326, 6,165,207, 6,149,670, 6,146,411, 6,126,684, 6,306,161, 6,264,679, 6,231,594, 6,149,676, 6,149,673, 6,110,168, 5,989,238, 5,879,329, 5,837,003, 6,383,210, 6,379,378, 6,364,899, 6,325,818, 6,312,452, 6,261,312, 6,254,626, 6,251,130, 6,251,129, 6,245,095, 6,238,428, 6,235,048, 6,231,595, and ppus 6,231,595, and 6,231,595, the entire contents of which are incorporated herein by reference. The catheter 12 may be placed in the venous system, for example, in the superior vena cava or inferior vena cava.

Instead of or in addition to the catheter 12, the system 10 may include more than one pad 18, the pads 18 being placed against the external skin of the patient 16 (only one pad 18 is shown for clarity). Without limitation, the gasket 18 may be any of the gaskets disclosed in the outer gasket patent. The temperature of the pad 18 can be controlled by the control system 14 to exchange heat with the patient 16, including inducing therapeutic mild or moderate hypothermia in patients with conditions that can be alleviated by hypothermia, such as cardiac arrest, myocardial infarction, stroke, high intracranial pressure, traumatic brain injury, or other conditions. The shim 18 may receive working fluid from the system 14 through a fluid supply line L3 and return the working fluid to the system 14 through a fluid return line L4. The pump "P" may be a peristaltic pump engageable with any one of the lines L1-L4, which utilizes peristaltic force to force working fluid through the lines to the working fluid, wherein the lines L1-L4 are typically IV lines of plastic or other material.

The control system 14 may include one or more microprocessors 20 that receive a target and patient temperature as inputs and controls, and in addition, a pump "P", a coolant compressor 22, and/or a bypass valve 24 that may be opened to allow coolant to bypass the condenser.

Turning now to fig. 2, an example of the pump "P" of fig. 1 is shown and generally designated 30. It will be appreciated that the pump assembly shown in fig. 2 is connected to cold plates 31 (shown schematically in fig. 2), between which plates 31 heat exchange bags or cassettes described below are placed to exchange heat with the working fluid flowing through the bags to the conduit 12 or gasket 18 and the working fluid from the conduit 12 or gasket 18. Details of an example of the interaction between the pouch and the cold plate are disclosed in U.S. patent application No.14/180,719, filed 2/14 2014, which is incorporated by reference herein.

The pump 30 includes a rotor 34 and a rigid track housing 32 or channel housing 32, preferably of metal or rigid plastic. The track housing 32, as shown, may be formed from one or more pieces of material and has an inner arcuate surface 36, which arcuate surface 36 may have a substantially constant radius of curvature. In some examples, the arc-shaped surface 36 defining the midpoint 38 between the two ends of the arc-shaped surface 36 may extend through an arc of at least 180 degrees (180 °) and may extend through an arc of between 180 degrees (180 °) and 270 degrees (270 °). In the example shown, the arcuate surface 36 extends through an arc of greater than 200 degrees (200 °) from one end to the other. For example, the arc may be about 210 ° to 230 °.

The motor 40 rotates the rotor 34 relative to the track 32. Likewise, as indicated by arrow 42, the rotor 34 is translatably movable relative to the track 32 between a pumping position, wherein the rotor 34 is spaced a first distance from the midpoint 38 of the inner surface 36 of the track 32, and a tube loading position, wherein the rotor 34 is spaced a second, greater distance from the midpoint 38. In the pumping or operating position, the rollers on the rotor 34 apply a force to tubing, such as IV tubing, disposed between the rollers and the track 32. In the tube loading position, the rotor 34 is spaced from the track 32 a sufficient distance to allow the tube 44 to be disposed between the track and the rotor and removed therefrom, such as by hand. The rotor 34 may be moved translationally by, for example, an actuator stepper motor, a manually actuated joystick linkage, or other suitable mechanism or component.

More than one roller is mounted on the rotor 34 to apply force to the tube 44 to pump fluid through the tube. In the example shown in fig. 2, the rotor 34 is defined in part by a rectilinear, non-square body, and the rollers are mounted on or near, e.g. rotatably mounted to, respective corners of the body. In this example, the drive rollers 46 are mounted (only one drive roller is shown in the perspective view of fig. 2) respectively to one set of opposing corners of the main body, and the guide rollers 48 are mounted respectively to the other set of opposing corners of the main body. Between the drive rollers 46 are therefore guide rollers 48.

As shown in fig. 2, the drive roller 46 has a cylindrical outer surface, and at least a portion of the outer surface is configured to apply force to the tube 44. The outer surface of an example drive roller may be a smooth cylinder only and/or it may or may not include one or more flanges having a perimeter that extends beyond the cylindrical outer surface. In contrast, the guide rollers 48 also have a cylindrical outer surface, but also include top and/or bottom flanges that define respective peripheral edges of the guide rollers that extend beyond the cylindrical outer surface so that the tubes 44 can be received between the flanges on the cylindrical outer surface of the guide rollers when the rotor 34 is in the pumping position and is rotating. In the example shown, two and only two drive rollers 46 and two and only two guide rollers 48 are provided, but any number of drive and/or guide rollers may be used. In particular embodiments, the drive roller or guide roller may have a non-cylindrical or partially cylindrical outer surface.

The tube 44 may be configured as a ring with the ends of the ring engaged with a chamber 50 of a working fluid cartridge, generally designated 52 (although the following embodiments refer to chambers, housings, compartments or other similar components may be used). The chamber 50 is hinged or connected to a framed cassette pocket 54. Details of examples of framed pockets 54 are discussed further below. Other example details that may be used for working fluid cartridge 52 are shown and described in U.S. patent applications 14/180,613 and 14/180,655 filed 2/24/2014, which are incorporated by reference herein. Such a cassette may be engaged with structure in control system 14 to exchange heat with a working fluid flowing through cassette 52 and tube 44 and circulated by pump 30 shown and described herein to and from a heat exchange member, such as conduit 12 and/or gasket 18, via, for example, lines L1 and L2 shown in fig. 1. Note that chamber 50 may also be connected to an external working fluid reservoir such as IV bag 57 via IV tubing.

When the bag 54 is disposed vertically between the cold plates 31 as illustrated in the above-incorporated U.S. patent application No.14/180,719, the chamber 50 may be locked in place as the rotor of the pump 30 moves into a pumping or operating position as described further below.

In an example, the cassette pouch 54 may be made of two polymer films closely spaced to each other and supported by a frame that slidably engages a slot 56 on a cold plate assembly supporting the pump of fig. 2. A working fluid chamber is established between the membranes. In one example, each film has a thickness of less than 2 mils (0.002 ") and more preferably between 1 mil and 2 mils (0.001" -0.002 "), inclusive. The exemplary preferred film is approximately square, with the top and bottom edges of the exemplary film being approximately equal in length (within ± 10% of the difference, and more preferably within ± 5%) to the left and right edges of the film. Thus, the working fluid chamber between the membranes may also be rectilinear and without obstacles between the membranes, meaning that the working fluid chamber is a completely rectilinear, nearly square chamber. In a preferred example, the film is stretched under tension during assembly to the frame.

Fig. 3 and 4 show that the cassette pocket 54 is bounded by a frame 60, and the chamber 50 is joined to the frame 60 at a hinge 62 for movement between a transport position (fig. 3) in which an open bottom side 64 of the chamber 50 is parallel to the frame 60 and closely spaced from the pocket 54, and an operative position (fig. 4) in which the open bottom side 64 is rotated 90 ° from the transport position to be perpendicular or nearly perpendicular to the frame 60. The hinged chamber or housing 50 provides a number of advantages and benefits. For example, it allows the cassette to easily assume a more compact transport configuration or operating position. Placing the chamber or housing vertically or at an angle relative to the frame provides increased angular tolerance (angular tolerance) between the cassette and the pump when the cassette is placed between the cold plates and connected to the pump. In addition, the perpendicular or angled configuration allows the user to obtain a top view of the pump with the cold plates in-line when the cassette is disposed between the cold plates and the tubing 44 is connected to the pump. Although the bottom side 64 of the chamber or housing is shown as having an open configuration, in certain embodiments, the bottom side may be closed or at least a portion of the bottom side may be closed. The bottom side 64 as shown is generally rectangular and extends along the width of the frame 60. In some examples, the chamber 50 or housing may be pivoted (pivoted) or rotated (pivoted) beyond the operational position to establish an obtuse angle relative to the frame 60 as shown in fig. 5. As best shown in fig. 3, the bottom side 64 is opposed by a complementary shaped closed or open top side 66 and is spaced from the top side 66 by a sidewall 68.

Fig. 6 shows the interior of the open bottom side 64 of the chamber 50. The return tube 70, carrying the working fluid from the conduit 12 or heat exchange pad 18, enters one of the two sides 60 of the chamber 50. The return pipe 70 passes through the chamber 50 to an inlet opening 74 into a head rail 76 on the opposite side supported by a support body or bearing 72. As will be discussed further with reference to fig. 11, return tube 70 terminates just below head rail 76 in pocket 54. As indicated by arrows 78, the working fluid flows out of the return tube and into the pockets 54, back through the pockets, and into an outlet tube 80, which outlet tube 80 extends through an opening in the head rail 76.

The outlet tube 80 passes, for example, through an inlet end connector 86 and into an enclosed working fluid reservoir 84 in the chamber 50. The reservoir may be a separate container or manifold placed in the housing or chamber or may be integral with the housing or chamber. The reservoir may collect or hold a quantity of working fluid necessary or required to operate the system. More than one level sensor may be provided in reservoir 84 to generate a signal when the reservoir fluid level drops to a threshold value. The signal may be used to activate an alarm light or an audible alarm. Note that in the bottom view shown, the inlet end connector 86 is located near the top of the reservoir 84. Also, an IV bag line or tube 87 is connected to the reservoir 84 via an IV bag connector 88 to supply the system with working fluid from the IV bag 57 shown in fig. 2. Although this embodiment refers to an IV bag, other sources of IV or working fluid, such as bottles, bags or other containers, etc., may be used. The reservoir 84 may be connected by a single line 87 to an IV bag used to deliver working fluid to the reservoir 84 and/or to compensate for thermal and other fluctuations in the volume of the working fluid, for example, during start-up of the system. The tubing 87 may also be used to evacuate air from the system and allow air to enter the IV bag and/or to carry working fluid back into the IV bag during the aspiration or evacuation of the system at the end of the procedure.

A single tube or tube 87 in a closed fluid loop provides a sterile barrier or environment for the working fluid and also provides enhanced or improved convenience. A working fluid, such as saline, may be delivered through the line 87 and air may travel back up through the same line 87 in the opposite direction if desired, for example during start-up, which allows two different fluids to be delivered through the same line. The transfer of the brine and air may not occur simultaneously and/or a filter may not be required. Closed fluid loops or closed loop systems utilizing a single IV bag line without a filter can operate for up to 7 days, and in particular embodiments can operate for more than 7 days. The pumps described herein can operate in both directions and the pumps can self-start so that the pumps can pump air and/or water and be operated even in a dry state.

Near the bottom of reservoir 94, outlet connector 90 establishes fluid communication between the working fluid in reservoir 84 and peristaltic tubing 44, which peristaltic tubing 44 extends through tubing outlet opening 92 to engage the peristaltic pump described above. The pump applies force to the tube 44 to circulate the working fluid in the flow paths described herein. The tube 44 re-enters the chamber 50 through the tube inlet opening 94 to engage with or be integral with the damper tube 96. The tubes 44 may be connected to downstream damper tubes or damper tubes directly or via an intermediate tube or manifold.

As shown, the example damper tube 96 has a larger diameter than the outlet tube 80, and also extends back and forth through the chamber 50, for example, curving through more than one 180 degree loop, more than once or multiple times, as shown. Alternatively, the damper tube may be located partially or entirely outside of the chamber. The purpose of the dampener tube 96 is to dampen the pulses in the working fluid caused by the peristaltic pumping action. The damper tube 96 is joined with a smaller diameter working fluid supply tube 98 at a clamp-like joint 100. The working fluid is delivered to the conduit 12 or the spacer 18 through the supply tube 98.

Fig. 7-10 illustrate an example interlock that may be provided between the pump 30 and the cassette 52. Fig. 7 and 9 illustrate the pump assembly with the rotor 34 in a loaded configuration or position, while fig. 8 and 10 illustrate the pump assembly with the rotor 34 in a locked (operating or pumping) configuration or position.

In fig. 7 and 9, a horizontal locking bar 120 terminating in an upwardly projecting engagement hook 122 is connected to a rotor carriage or motor mount (motor mount) supporting the rotor 34 such that the locking bar 120 moves with the rotor carriage or mount in the direction indicated by arrow 124 and the rotor moves as described with reference to fig. 2. The rotor carriage or base (and thus the locking lever 120) is in the loading position in fig. 7 and 9, with the rotor 34 away from the track or track surface 36 to allow the pump tube 44 of the cassette 52 to engage or be placed in the space between the rotor 34 and the track. As shown in fig. 9, in this position, the engagement shelf 126 or protrusion on the bottom of the cassette 52 disengages the engagement hook 122, allowing the cassette 52 to move to place the pump tube 44 in the track 32.

In contrast, fig. 8 and 10 show that when the rotor carriage or base and rotor 34 are moved to the locked, pumping or operating position so that the pump rollers can force the pump tube 44 against the track or track surface 36, the locking lever 120 is also moved to a position that moves the engagement hook 122 to the top surface of the engagement shelf 126, the catch shelf 126 and thus the cassette 52 so that the cassette 52 cannot be retracted while the rotor carriage or base, rotor and locking lever 120 with the hook 122 are in the locked, pumping or operating position.

Fig. 11 illustrates that in some examples, working fluid from the return tube 70 of fig. 6 passes through the chamber 50 or housing (not shown in fig. 11) to the inlet tube 130 (which may be the same as or connected to the return tube). Inlet tube 130 enters opening 13 in top rail 134 of cassette frame 602 to enter the pocket 54. In the example shown, inlet tube 130 terminates in head rail 134 or just below (e.g., below) head rail 134¹/₄") so that the working fluid exits the inlet tube 130 proximate the head rail 134, flows downward and through the bag 54.

A drain tube 138 having a smaller diameter than the inlet tube 130 extends through the inlet tube 130, as shown toward a bottom rail 140 of the frame 60, the bottom rail 140 being opposite and parallel to the head rail 134. Drain tube 138 terminates proximally (e.g., at¹/₄"left and right) opening 142 of bottom rail 140. As the working fluid circulates through the catheter 12 and the pouch 54 during patient temperature management operations, at least a portion of the working fluid returning from the catheter 12 to the cassette 52 exits the larger diameter opening of the inlet tube 130 near the top of the cassette 52 and at least a portion of the working fluid flows downward and through the pouch 54 to exchange heat with the cold plates between which the pouch 54 is disposed.

When it is desired to drain the conduit and/or bag to facilitate withdrawal of the bag 54 from the cold plate, the pump may be reversed, wherein withdrawal of the bag 54 from the cold plate may be impeded if the bag 54 remains filled with the working fluid. This evacuates the working fluid from the bag 54 through the drain tube 138. Evacuation causes the bag material to collapse around the larger inlet tube 130 leaving most of the suction (suction) at the opening 142 of the drain tube 138. The working fluid is pumped back into the reservoir 84 in the chamber or housing through the drain tube 138 and from there to the IV bag. The working fluid is also evacuated from the conduit while the conduit remains connected to the cartridge 52. When the tubing is not connected prior to venting the bag 54, the connectors, typically Luer fittings, connecting the tubing IV lines to the supply and return lines of the cassette may simply be connected together to close the fluid ring.

In certain embodiments, a check valve 81 (fig. 6) may be placed on or in the tubing or pipe between heat exchange bag 54 and storage portion 84 to prevent working fluid from moving back from storage portion 84 into heat exchange bag 54 during evacuation or suction. Optionally, a check valve 81 may be placed inside storage portion 84 to prevent working fluid from moving back from storage portion 84 into heat exchange bag 54 during evacuation or suction. Such a valve may ensure that the working fluid is evacuated and/or flows back to the IV bag or other container so that the heat exchange bag may be properly drained and easily removed from between the heat exchange plates. The working fluid may also be evacuated or discharged from the catheter, which when connected to the system, causes the diameter of the catheter to decrease so that the catheter can be removed from the patient. If desired, the conduit may be disconnected so that the working fluid is only evacuated or drained from the heat exchange bag. In other embodiments, a high pressure damper providing working fluid volume fluctuations may be used so that the working fluid may be pumped or discharged with or without a check valve.

In certain embodiments, when filling the cassette bag during start-up, the pump may be turned on and off for a short time to allow air to vent back through the reservoir in the chamber or housing. The pump may also be reversed to speed up the return of air through the reservoir and/or the movement of air to the IV bag or fluid source. Without the use of a filter, a single line may be used to transfer liquid and/or air between the reservoir and the IV bag or fluid source.

Components included in one embodiment may be used in other embodiments in any suitable combination. For example, any of the various components described herein and/or depicted in the drawings may be combined, interchanged, or excluded from other embodiments.

A "system having at least one of A, B and C" (likewise, "a system having at least one of A, B or C" and "a system having at least one of A, B, C") includes systems having a alone, B alone, C, A and B alone, a and C together, B and C together, and/or A, B and C together, and the like.

While various embodiments of a working fluid cassette having a hinged chamber or housing for connecting a heat exchanger with an intravascular temperature management catheter are illustrated and described in detail herein, the scope of the invention is not limited in any way except as by the appended claims.