DUAL CHAMBER BLOOD HAND PUMP

A dual chamber single-hand pump is described that includes a pump chamber with four fluid pathways. Two pathways are configured to conduct fluid to the chamber and to stop flow therethrough from the chamber, and two pathways are configured to conduct fluid from the chamber and to stop flow therethrough to the chamber. A piston positioned and moveable within the chamber separates two of the pathways from the other two pathways within the chamber. The pump can be held in a single hand by having finger grips for stabilizing the pump and a palm grip for advancing the piston. A return spring can return the piston to the original position when the palm is relaxed to allow expansion of the spring.

BACKGROUND

Therapeutic treatments can include the preparation of equipment and infusion of a medical fluid (e.g., blood, plasma, saline). This is prepared for and communicated to patients using an IV catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an “IV set.” The equipment often includes connection to a source of fluid, for example, an IV blood bag. During operation or use, medical fluid may be required quickly at greatly increased flow rates, as shorter times to perform blood transfusions have been associated with decreased death risk in trauma patients. Typical IV sets use a cylindrical hand pump that is squeezed by hand to rapidly increase fluid flow rate, resulting in muscle fatigue.

SUMMARY

For these reasons, it is desirable to provide an IV set hand pump that is constructed to operate without extensive effort or time and with a single hand by the user. This can help reduce hand muscle fatigue and complexity of use.

This subject technology provides an IV set designed for delivery of fluids at high flow rates, particularly addressing the delivery of large volumes of blood in trauma situations. Described herein are single-hand pumps for use with an intravenous delivery system. The pumps can include a pump chamber comprising a plurality of ports that provide fluid pathways through a wall of the chamber housing; and a plunger positioned within the chamber and configured to be reciprocally axially moveable in the chamber, the plunger separating the chamber into a first chamber and a second chamber. Some embodiments provide that the first chamber is in fluid communication with a first plurality of ports, the second chamber is in fluid communication with a second plurality of ports, the first plurality of ports being fluidly isolated through the chamber from the second plurality of ports by the plunger. In some embodiments, when the plunger is axially advanced toward the first plurality of ports, fluid is expelled from the chamber through a first of the first plurality of ports and restricted from being expelled through a second of the first plurality of ports, and fluid is conducted into the chamber through a first of the second plurality of ports and restricted from being conduct into the chamber through a second of the second plurality of ports. Some embodiments provide that when the plunger is axially advanced toward the second plurality of ports, fluid is expelled from the chamber through one of the second plurality of ports and restricted from being expelled through another of the second plurality of ports, and fluid is conducted into the chamber through a one of the first plurality of ports and restricted from being conduct into the chamber through another of the second plurality of ports.

Described herein are embodiment that further include a return spring that is compressed when the plunger is advanced in a first direction and expands when the plunger is advanced in a second direction. Some embodiments include a handle that is configured to be pressed by a palm of a user, and some include a plurality of finger grips that are configured to be engaged by a user's fingers. In some embodiments, the single-hand pump is configured to be actuated by a single hand of a user as the plunger advances toward the first plurality of ports and as the plunger advances toward the second plurality of ports.

In some of the embodiments described herein, the first plurality of ports comprises at least two one-way valves, and in some embodiments, the at least two one-way valves comprise ball valves. In some embodiments, the second plurality of ports comprises at least two one-way valves, and in some embodiments, the at least two one-way valves comprise ball valves.

Some embodiments of the subject technology described herein include a single-hand pump for use with an intravenous delivery system that has a pump chamber comprising a first fluid pathway, a second fluid pathway, a third fluid pathway, and a fourth fluid pathway, the first and third pathways configured to conduct fluid to the chamber and to stop flow therethrough from the chamber, the second and fourth pathways configured to conduct fluid from the chamber and to stop flow therethrough to the chamber. Some pumps described herein include a piston positioned within the chamber, the piston being moveable between first and second positions and fluidly separating the first and second fluid pathways from the third and fourth fluid pathways within the chamber, wherein when the piston is moving toward the first position, fluid is conducted through the second and third fluid pathways and stopped through the first and fourth fluid pathways, and when the piston is moving toward the second position, fluid is conducted through the first and fourth fluid pathways and stopped through the second and third fluid pathways.

Some embodiments further include first, second, third, and fourth ports fluidly coupled to the chamber providing respective flow along the first, second, third, and fourth fluid pathways. Some embodiments also include a plurality of one-way valves in each of the ports, the valves configured to conduct or stop the flow during movement of the piston. In certain embodiments, the plurality of one-way valves comprises a ball valve.

Some of the described embodiments include a plurality of finger grips that are configured to be engaged by a user's fingers, wherein the single-hand pump is configured to be actuated by a single hand of a user as the plunger moves between the first and second positions. In some embodiments, a return spring is compressed as the piston moves in one direction and expands as the piston moves in another direction, and the piston is configured to move in the one direction by a user's action, and the piston is configured to move in another direction by expansion of the return spring.

Methods of using a dual chamber pump are also described herein. The methods can be for treating a patient or for preparing a set of lines for treatment, also referred to as priming the set. Methods of conducting fluid through an intravenous delivery system using a single-hand pump can include providing a pump chamber comprising a first fluid pathway, a second fluid pathway, a third fluid pathway, and a fourth fluid pathway, the first and third pathways configured to conduct fluid to the chamber and to stop flow therethrough from the chamber, the second and fourth pathways configured to conduct fluid from the chamber and to stop flow therethrough to the chamber. Some methods include providing a piston positioned within the chamber, the piston fluidly separating the first and second fluid pathways from the third and fourth fluid pathways within the chamber. Some methods also include the step of moving the piston between first and second positions, and wherein when the piston is moving toward the first position, fluid is conducted through the second and third fluid pathways and stopped through the first and fourth fluid pathways, and when the piston is moving toward the second position, fluid is conducted through the first and fourth fluid pathways and stopped through the second and third fluid pathways.

Some methods may also include providing first, second, third, and fourth ports fluidly coupled to the chamber. In some instances, some methods further include conducting and stopping fluid flow along the first, second, third, and fourth pathways via one-way valves.

According to various aspects of the subject technology, an infusion system for intravenous delivery of a fluid from a fluid container, comprises a malleable fluid container configured to store a fluid and deliver the fluid via a connected infusion tubing; a fluid container pressure sleeve configured to wrap around, connect and form to the malleable fluid container such that, when the fluid container pressure sleeve is inflated with a gas, the fluid container pressure sleeve applies an inward directional pressure to the malleable fluid container from an exterior of the malleable fluid container; a pump configured to provide the gas to the fluid container pressure sleeve; and a pressure measuring device configured to measure a pressure associated with the malleable fluid container by the fluid container pressure sleeve.

DETAILED DESCRIPTION

It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

FIG.1depicts a schematic view of a patient110connected to an intravenous system incorporating aspects of the disclosure. Intravenous fluids, such as a blood infusate, are often contained in malleable (e.g., flexible) bags, commonly referred to as intravenous or “IV” bags. These bags, or fluid source120, can be equipped with multiple septums or other fluid connections that permit connection of the bag to a tube that feeds the fluid to the patient110. The bags are generally floppy, although the fluid sources120need not be floppy bags, and the bags may be subject to puncture if they come into contact with sharp items. Alternate containers, which are more prevalent in some countries, include glass bottles and soft plastic bottles.

Administration of these IV fluids, regardless of the container, requires that the fluid source120be suspended at some height, typically 0.5-1.0 meter, above the patient110or an infusion pump. This container is then connected by a flexible tube to either the patient110directly or to the infusion pump. Mounting the fluid source120above the delivery point generates a positive pressure due to gravity at the connection of the infusion tube to the patient110or pump. One embodiment of such a mounting is illustrated inFIG.1, wherein an IV bag is mounted in an elevated position. An input line130is connected to the fluid source120via a drip chamber140. Fluid flow is provided to the input line130through the drip chamber140from the fluid source120.

Flow may be achieved by either gravity-pressure or positive-pressure. Gravity-pressure based flow control systems rely on the force of gravity for fluid flow. Such systems, generally referred to as gravity sets, may include an “IV controller” which interfaces with the IV tube. An IV controller may be a device that automatically controls the flow rate of fluid through the IV tube by use of a pinching device that pinches the tube at different degrees to control the flow of fluid therethrough. In some instances, an IV controller may be a manually manipulated device that a caregiver uses and adjusts to pinch the tubing. In some instances, an IV controller may also be responsive to a control signal generated by, for example, a flow sensor attached to the drip chamber. Advantages of gravity sets include their relative simplicity and low cost. The pinching device comprises a relatively simple mechanical device under electrical control. IV controllers, however, are limited to gravity pressure, dependent upon the “head height” or “head pressure” of the administration fluid, which can be under 1 psi.

In certain situations, the amount of pressure provided by a gravity-pressure based flow control device may be insufficient. In other situations, greater accuracy and precision of flow rates are required. In such situations, a positive pressure flow control device is necessary.

A separate infusion pump (not depicted) may be used to infuse the fluid with a greater flow rate than that dependent upon gravity. Some infusion pumps act as flow control devices to act on the respective tube or fluid conduit of the fluid administration set to move the fluid from the fluid container through the conduit to the patient110at a desired rate. However, in some circumstances, it may be required to use a gravity set without a separate infusion pump such as, for example, when a separate infusion pump is not available or accessible. Yet, in some instances, it may be desirable to provide fluid flow with gravity sets that provide a greater flow than that resulting from the positive pressure due to gravity.

Some instances where it may be desirable to increase fluid flow are, for example, when delivering large amounts of blood over a small period of time, such as in trauma situations. In such instances, a separate infusion pump may not be available, and it may be desirable to use an in-line hand pump, or in some cases pressure sleeves around the blood IV bag that are also manually pumped operated, to provide blood flow to the patient at a great flow than that achievable through a standard gravity set. With further reference toFIG.1, embodiments in which a hand pump150is provided in line with a gravity set. As depicted, the hand pump150can be connected to the input line130on one end and an output line160on another end. The output line160can extend from the hand pump150to an IV injection set170that is configured to communicate fluid to the patient's110vasculature.

Medical fluid administration sets, including gravity sets, may have more parts than are shown inFIG.1. For example, as illustrated inFIG.2, IV sets may be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are disposable products that are used once and then discarded. The infusion components and tubing may be formed from any suitable material (e.g., plastic, silicone, rubber, PVC), many or all of which are clear or translucent so that the fluid flow or levels inside can be seen.

As shown inFIG.2, IV sets may include one or more IV bag needles210and one or more roller clamps220connected by tubing. The IV set may also include a Y-site or a drip chamber140that combines the tubing from the one or more IV bag needles210. The drip chamber140may be connected to the input line130, the hand pump150, and the output line160. Flow through the output line may be controlled by another roller clamps220. And the output line160may be connected to an IV injection set170that is configured for delivering fluid to the patient110(shown inFIG.1).

In use, IV set is connected to a fluid source120(e.g., a blood bag) via the drip chamber140, the input line130, the hand pump150, and the output line160. The output line160is connected to a catheter that is placed into a vein of a patient. Thus, fluid flows from the fluid source120, through the drip chamber140to the hand pump150and through the remainder of the IV set and out of the injection set170. As the hand pump150is actuated or squeezed, the volume of fluid contained within a hand pump chamber310is forced out of the hand pump150through the output line160and downstream through the injection set170.

FIG.3illustrates a perspective view of a hand pump150in accordance with embodiments described herein. The hand pump150preferably includes a chamber310that may be generally cylindrical. The chamber310may have a forward chamber320and a rearward chamber330. Extending in one direction from the chamber310, for example, rearwardly from the rearward chamber330as illustrated inFIG.3, is a piston slider340. A push rod350is configured to extend into at least a portion of the piston slider340on one end and is connected to a grip handle360on an opposing end. A return spring370is preferably positioned between opposing surfaces on the grip handle360and the piston slider340to resist movement of the grip handle360toward the piston slider340.

During use of the hand pump150, the grip handle360is pressed forward toward the piston slider340or chamber310. As the grip handle360is pressed forward toward the piston slider340, the push rod350is advanced within the piston slider340, and the return spring370is compressed between the advancing grip handle360and the piston slider340. When the grip handle360is no longer pressed forward toward the piston slider340and the pressing force is removed from the grip handle360, the return spring370expands to press the grip handle360away from the piston slider340, thereby advancing the push rod350rearwardly out of the piston slider340.

The operation of the hand pump150includes the reciprocating action of advancing the grip handle360and push rod350forward toward the chamber310to actuate the pump in one motion. The hand pump150then operates in a second motion when pressure against the grip handle360is released and the return spring370is allowed to expand and move the grip handle360and the push rod350rearwardly away from the chamber310. As this action is repeated, the hand pump150pumps fluid toward the patient.

FIG.3further depicts a plurality of input and output ports for communicating fluid from the input line130to the output line160via the pump chamber310. The hand pump150preferably includes a first input port410that is in fluid communication with a first input line420and the chamber310and is configured to conduct fluid from the first input line420into the chamber310. A second input port430is in fluid communication with a second input line440and the chamber310and is configured to conduct fluid from the second input line440into the chamber310.

The hand pump150preferably includes a first output port450that is in fluid communication with a first output line460and the chamber310and is configured to conduct fluid from the chamber310to the first output line460. A second output port470is in fluid communication with a second output line480and the chamber310and is configured to conduct fluid from the chamber310to the second output line480.

In operation, the reciprocating action of the hand pump150directs fluid through the ports to pump the fluid toward the patient. When the grip handle360is first advanced forward, fluid is expelled from the chamber310through the second outlet port470, and during this first motion, fluid is drawn through the first input port410into the chamber310. When the grip handle360is allowed to be drawn rearwardly by the return spring370, the flow of fluid through the chamber310changes. During this second motion, fluid is expelled from the chamber310through the first output port450and is drawn into the chamber310through the second input port430.

FIG.4illustrates operation of the hand pump150by a user's single hand510. Single hand use of the pump150by providing finger grips520on the sides of the hand pump150. In some instances, the operation of the hand pump150can by similar to that of a common syringe. With two fingers extending through the finger grips520, a user can depress the grip handle360to actuate the pump150in a first direction. For the second direction of the pump's operation, the user can release pressure against the grip handle360while keeping the fingers through the finger grips520. The fingers in the finger grips520will keep the pump150stabilized and in the user's hand, and releasing pressure against the grip handle360will allow the return spring370to advance the grip handle360rearwardly. This action can continue repeatedly to pump fluid to the patient by a single hand of the user.

FIG.5illustrates a cross-sectional view of the dual chamber hand pump150that shows how the pump150can conduct fluid during each of the motions, or actions, of the pump150described herein. The chamber310of the hand pump150includes an internal chamber wall610that defines a first chamber portion620and a second chamber portion630. The first chamber portion620and the second chamber portion630is separated by a piston disk640that is moveably mounted within the chamber310. The piston disk640is preferably connected, either through assembly or integrally formed, with a piston rod650that extends rearwardly from the piston disk640and through at least a portion of the piston slider340. In some embodiments, the piston disk640and piston rod650form a plunger. Although the disk is shown in embodiments described herein as a flat cylindrical disk, the disk can have other forms that are not cylindrical. As the piston disk640is advanced forwardly, toward a chamber forward end660, the second chamber portion630decreases in volume, and the first chamber portion620increases in volume.

As described herein, fluid flow is provided to the chamber310from first and second input lines420,440through first and second input ports410,430. Fluid flow is expelled from the chamber310to first and second output lines460,480through first and second output ports450,470. The first input port650and the first output port450are in fluid communication with the first chamber portion620. The second input port430and the second output port470are in fluid communication with eh second chamber portion630. Each of the ports are shown with a valve670that controls fluid flow therethrough and to ensure the flow through the ports are one directional. These one-way valves ensure that while one of the chamber portions620,630is expanding, fluid is drawn from the source into the chamber310and not from down line of the chamber310. Likewise, these one-way valves ensure that while one of the chamber portions620,630are contracting, fluid is expelled toward the patient110and not toward the fluid source120.

Movement of the piston disk640within the chamber310is controlled by depressing or releasing the grip handle360. When the grip handle360is pressed forwardly, the push rod350is advanced toward the chamber310. A push rod forward end680coupled to or otherwise connected with the piston rod650advances the piston rod650through the piston slider340and moves the piston disk640towards the chamber forward end660. When the grip handle360is released, the return spring370presses the grip handle360rearwardly and draws the piston disk640rearwardly away from the chamber forward end660.

FIG.6illustrates a partial cross section exploded view of the hand pump150. The chamber310is illustrated in a rotated cross-sectional view as compared toFIG.5, depicting the finger grips520and a first inlet aperture710and a second inlet aperture720through which fluid is conducted into the chamber via the first input port410and the second input port430, respectively. Although not depicted inFIG.6, a first outlet aperture and a second outlet aperture are included in the chamber wall610separated from the first and second input ports710,720. As depicted in the figure, the chamber wall610defines a generally cylindrical chamber310that is configured to contain a piston disk640and reciprocally moves axially within the cylindrical chamber310along a general axis of the chamber310.

The piston disk640preferably includes a piston ring730that circumferentially and/or peripherally extends around an outer edge of the disk640such that the piston ring730seals against the chamber wall610as the piston disk640moves within the chamber310. The piston ring730seals against the chamber wall610to restrict fluid communication between the first chamber portion620and the second chamber portion630. Extending from one face of the piston disk640is the piston rod650, which includes one or more piston rod seals740axially spaced and separated along the piston rod650. The piston rod seals740are configured to seal against an inner surface of the piston slider340to restrict fluid from being expelled from the chamber310through the piston slider340. A piston rod rearward end750is configured to be coupled or connection to the push rod forward end680such that axial or rotational manipulation of the grip handle360will be transferred through the push rod350, the piston rod650, and to the piston disk640.

The input ports410,430and the output ports450,470are each configured to connect to tubing at one part of the port and the hand pump150at another part of the port. The ports are configured to provide fluid communication between the tubing and the hand pump150. The ports can include an inlet aperture750and an outlet aperture760that conduct fluid through each port. The ports preferably include a one-way valve, depicted inFIG.6as a ball valve770, that permits fluid to pass through the respective port in only a single direction. For example, the first and second input ports410,430may include a ball valve770that permits fluid flow from the first and second input lines420,440into the chamber310. They may also resist or prevent fluid flow from the chamber310toward the first and second input lines420,440. The one-way valve function may be accomplished by providing a ball valve seating profile for the ball that matches the contour of the ball on the side of the ball that leads to the first and second input lines420,440while providing flow paths past or around the ball on the side of the ball that leads to the chamber310. Accordingly, when fluid flows from the first and second input lines420,440, the ball is pressed toward the chamber310where flow paths past or around the ball are provided, thus permitting flow in that direction. When fluid pressure changes, such that flow would otherwise be conducted toward the first and second input lines420,440, the ball is pressed against the ball valve seating profile that matches the contour of the ball, and fluid is restricted or prevented from passing around the ball toward the first and second input lines420,440.

The first and second output ports450,470operate in an opposite manner as that described with respect to the first and second input ports410,430. Each of the first and second output ports450,470preferably includes a one-way valve, depicted inFIG.6as a ball valve770, that permits fluid to pass through the respective port in only a single direction. The first and second output ports450,470may permit flow from the chamber310toward the first and second output lines460,480but resist or prevent fluid flow from the first and second output lines460,480toward the chamber310. The one-way valve function of ports450,470may be accomplished by providing a ball valve seating profile for the ball that matches the contour of the ball on the side of the ball that leads toward the chamber310while providing flow paths past or around the ball on the side of the ball that leads to output lines460,480. Accordingly, when fluid flows from the chamber toward the output lines460,480, the ball is pressed toward the output lines460,480where flow paths past or around the ball are provided, thus permitting flow in that direction. When fluid pressure changes, such that flow would otherwise be conducted toward the chamber310, the ball is pressed against the ball valve seating profile that matches the contour of the ball, and fluid is restricted or prevented from passing around the ball toward the chamber310.

While embodiments shown herein depict a one-way valve that illustrates a ball valve, other one-way valves may also be used in similarly coordinating manner to accomplish the same or similar functions as that described above. For example, duckbill valves, umbrella valves, flapper valves, and other one-way valves may be used in various embodiments to achieve the one-way function that is accomplished during the pumping process for the hand pump150.

FIGS.7-9depict operation of the dual chamber hand pump150. In order to operate the hand pump150, either to infuse fluid to a patient or to prime a fluid line, the operator takes the hand pump150in hand and presses the grip handle360with a forward force810. When the grip handle360is pressed with a sufficient forward force, the piston rod650and piston disk640will advance in the forward direction820. Forward movement of the piston disk640will reduce the size of the second chamber portion630, causing a positive pressure to be applied to the fluid in the second chamber portion630. This positive pressure will cause fluid to be expelled from the chamber310through the second outlet port470as indicated by the arrow showing output flow830. The second input port430preferably includes valve670, which will prevent or restrict fluid from flowing through the second input port430.

As the second chamber portion630decreases in size, the first chamber portion620increases in size, creating a negative pressure to form in the first chamber portion620. An arrow depicting input flow840is illustrated, reflecting fluid flow through the first input port410toward the first chamber portion620. This fills the first chamber portion620in balance with the fluid that is expelled from the second chamber portion630. Fluid that may otherwise be drawn in through the first output port450is prevented or restricted by the valve670in the first output port450.

FIG.8depicts when the grip handle360is fully depressed in the forward direction820. At this point in the operation, substantially no fluid will be drawn through the input ports or the output ports, and the piston disk640experiences a reversing direction850. The piston disk640stops moving forward and switches to a point ready to reverse its direction of movement.

FIG.9illustrates an expanding force860applied by the compressed return spring370, as the compressed spring is forced to expand against the grip handle360. This force moves the piston rod650and the piston disk640in a rearward direction870. As the piston disk640moves in the rearward direction870, the first chamber portion620will reduce in size, creating a positive pressure in the first chamber portion620. This positive pressure will cause output flow830from the chamber310through the first outlet port450. Valve670in the first input port410prevents or restricts fluid from flowing through the first input port410from the first chamber portion450.

As the first chamber portion620decreases in size, the second chamber portion630increases in size, creating a negative pressure to form in the second chamber portion630. Input flow840is provided through the second input port430to fill the second chamber portion630in balance with the fluid that is expelled from the first chamber portion620. Fluid is not drawn through the second output port470because valve670prevents or restricts fluid to flow through the second output port470toward the chamber310.

The operation of reciprocal motion pressing the grip handle360and allowing it to expand under the force of the return spring370draws fluid into the chamber310and expels fluid from the chamber310with each stroke, thereby providing a relatively consistent flow operation for either infusing a patient or priming a fluid line. During operation, the hand pump150can pump fluid at a rate of 13-15 liters per hour, and in some embodiments, the hand pump150can pump fluid at a rate greater than 15 liters per hour.

It is understood that any specific order or hierarchy of blocks in the methods of processes disclosed is an illustration of example approaches. Based upon design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks be performed. In some implementations, any of the blocks may be performed simultaneously.

As used herein, the terms “provide” or “providing” encompass a wide variety of actions. For example, “providing” may include storing a value in a location of a storage device for subsequent retrieval, transmitting a value directly to the recipient via at least one wired or wireless communication medium, transmitting or storing a reference to a value, and the like. “Providing” may also include encoding, decoding, encrypting, decrypting, validating, verifying, inserting and the like via a hardware element.

It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter. The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.