Patent ID: 12208233

DETAILED DESCRIPTION

The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions may be provided in regard to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology.

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.

During infusion with gravity sets or a pump that does not have a keep-vein-open (KVO) function, an unattended complete infusion can lead to a loss of patency in the catheter due to blood diffusing back through the catheter tip. The blood will begin to coagulate, which will seal off the flow in the catheter, making it unusable. If infusion is to continue, the clinician must remove the catheter and re-insert a new one into the patient, which is costly, painful to the patient, and time consuming.

Some gravity sets attempt to address the above issue by employing a device that utilizes the patient's blood pressure to flow out through an injection site into a container with a plunger. The device is used mainly for keeping the vein open during the infusion of contrast media. The plunger is driven back with the blood pressure and can be driven with a motor to help draw out blood if the blood pressure is not enough to drive the plunger.

The present description relates in general to drip chambers, and in particular to a drip chamber including a drip chamber insert capable of slowing down the flow rate of the final volume of fluid in the drip chamber towards completion of infusion to allow the patient's vein to stay open until a clinician can tend to the completed infusion.

According to various embodiments of the present disclosure, the drip chamber assembly may be fluidly coupled to a catheter which may be inserted into a vein of a patient for infusion of an IV fluid and/or blood draw. In some embodiments, the drip chamber assembly may include a drip chamber having an additional component mounted or otherwise affixed therein. The additional component may be welded, glued, or otherwise similarly affixed to a base portion of the drip chamber. In some embodiments, the additional component may be a drip chamber insert that is affixed (for example, but not limited to welded or glued) into the drip chamber with the capability of slowing down the flow of the final volume (for example, but not limited to the final 10-60 milliliters (ml)) of IV fluid remaining in the drip chamber after depletion of the IV fluid in the IV fluid bag. The slowing of the flow rate of the IV fluid at completion of the infusion may advantageously allow a patient's vein to stay open longer until a clinician can tend to the completed infusion.

In some embodiments, the drip chamber insert may split or otherwise partition the drip chamber into two chambers: (i) a first chamber having an inlet orifice (also referred to herein as a normal flow orifice) for normal, unrestricted flow of the IV fluid, and (ii) a second chamber with a small orifice at a bottom or base of the second chamber that allows for a greatly reduced keep-vein-open (KVO) flow rate of the IV fluid. In some embodiments, an anti-run-dry filter or membrane may be attached to an upper surface of drip chamber insert extending over the top of the normal flow orifice to ensure that when the IV fluid in the drip chamber falls below the predetermined threshold value, the anti-run-dry membrane may restrict or otherwise block the remaining IV fluid from entering the normal fluid pathway in the first chamber. Accordingly, the remaining IV fluid in the drip chamber will flow through the path of less fluid flow resistance; the KVO fluid pathway delivers fluid to the patient at the greatly reduced flowrate via the low flowrate orifice.

For example, in some embodiments, the normal fluid pathway may deliver the fluid at a flow rate ranging from about 50 milliliters/hour (ml/hr) to about 1000 ml/hr, in some instances ranging from about 200 ml/hr to 800 ml/hr, more typically from about 400 ml/hr to 600 ml/hr, and in some embodiments approximately 500 ml/hr. In contrast, in some embodiments, the KVO fluid pathway may deliver the fluid at a reduced flow rate ranging from about 2 ml/hr to about 10 ml/hr, in some instances ranging from about 3 ml/hr to 9 ml/hr, more typically from about 5 ml/hr to 7 ml/hr, and in some embodiments approximately 6 ml/hr. Accordingly, towards completion of infusion, the IV fluid may be dispensed to the patient via the low flowrate orifice to allow the patient's vein to stay open until a clinician can tend to the completed infusion.

Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific angles, within this full range or any specifically recited range.

According to various embodiments of the present disclosure, the IV set including the drip chamber and drip chamber insert may mainly rely on gravity or suction from a pump for flow of the IV fluid. Once flow above the drip chamber stops (e.g., upon depletion of the IV fluid in the IV bag), the IV fluid in the drip chamber will continue to flow into the IV tubing to the patient. When the IV fluid level in the drip chamber drops to a predetermined threshold level, for example, a level corresponding to the height of the anti-run-dry membrane, the normal fluid path is blocked by the anti-run-dry membrane, thereby causing the remaining IV fluid to proceed through the KVO path and to the patient via the low flowrate orifice. The small orifice significantly lowers the flow rate of the remainder of the IV fluid.

Accordingly, the various embodiments of the present disclosure are advantageous in providing a drip chamber assembly capable of dispensing the last few milliliters of IV fluid to a patient at a reduced flow rate in order to keep the vein open once the IV fluid in the IV bag is depleted. The drip chamber assembly with drip chamber insert of the various embodiments described herein is further advantageous as it does not require modifications to the existing drip chamber other than affixing the drip chamber insert therein, thus only minimal change to the currently existing IV sets is necessary. As can be appreciated, no modifications to the pump are required. Further advantageously, the drip chamber insert does not require complex electronics or other technology in order to be integrated into the currently existing drip chamber. The drip chamber insert accomplishes the described function as a mechanical device with a mechanical connection. Additionally, the drip chamber assembly with the drip chamber insert of the various embodiments described herein is advantageous in that no additional training is required to use it. Further advantages are realized in time savings with respect to infusion therapy time for the medical personnel by eliminating the need to reinsert the catheter due to blood coagulation, which is commonly associated with gravity sets or pumps that do not have a keep-vein-open (KVO) function. Furthermore, since the catheter does not need to be reinserted, this has the effect of reducing or otherwise eliminating pain to the patient associated with reinserting the catheter.

FIG.1illustrates a multiple line IV extension set10that includes a drip chamber assembly100in accordance with some embodiments of the present disclosure. The drip chamber assembly100may be fluidly coupled to a catheter60which may be inserted into a vein of a patient for infusion of an IV fluid and/or blood draw. As depicted, IV set10includes a primary fluid system2and a secondary fluid system4. An IV pump (not shown) receives fluid from primary fluid system2and secondary fluid system4via a primary IV fluid line5and a secondary IV fluid line7, and may control and dispense the fluids therefrom to a patient55.

In some embodiments, primary fluid system2may include a primary fluid source or container such as a primary intravenous (IV) fluid bag3, which may include or contain a first medical fluid, for example, saline solution or other medicinal fluid or drug to be administered to the patient. As illustrated, IV tubing116may carry flow from the drip chamber assembly100to a Y-connector12. Check valve14may be disposed in tube6upstream from the Y-connector12and enables flow from fluid bag3to the IV pump (not illustrated) while preventing reverse flow (backflow) of fluid from auxiliary fluid system4toward fluid bag3.

In accordance with some embodiments, secondary fluid system4may include a secondary fluid source or container such as a secondary IV fluid bag8, which may contain a second medical fluid, for example, drugs or other secondary fluid to be supplied to the patient55for treatment via the catheter60. A secondary fluid line9carries flow from a drip chamber11to the Y-connector12.

In some embodiments, the second medical fluid may be different from the first medical fluid. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In other embodiments, the first and second fluids may be the same.

According to various embodiments of the present disclosure, as illustrated inFIG.1, primary IV fluid bag3, which holds a primary fluid, may be positioned at a lower axial position or height than the secondary IV fluid bag8. For example, the primary IV fluid bag3may be hung on a suspension system or hanger and then the secondary IV fluid bag8may be hung above the primary IV fluid bag10and may be coupled to the secondary fluid line9, which may be connected to the primary fluid line5via a connector (e.g., a y-site connector).

FIG.2illustrates a perspective view of the drip chamber assembly100, in accordance with some embodiments of the present disclosure. According to various embodiments of the present disclosure, a drip chamber assembly100may include a drip chamber110and a drip chamber insert120. The drip chamber110may include a housing112having an inlet114for receiving an IV fluid, an outlet116for dispensing the IV fluid to a patient, and a cavity118defined by an inner surface119of the housing112. As depicted, the drip chamber insert120may be disposed in the cavity118of the drip chamber housing112.

FIG.3illustrates a perspective view of the drip chamber110and drip chamber insert120of the drip chamber assembly100ofFIG.2, in accordance with some embodiments of the present disclosure. In some embodiments, the drip chamber insert120may include a longitudinally extending or elongate body portion122having an upper surface126and a base portion124disposed downstream or at a distal end of the elongate body portion122. The base portion124may define an outlet orifice128of the drip chamber insert120and be fluidly connected to the outlet116of the drip chamber110. In some embodiments, the drip chamber insert120may include a first chamber130and a second chamber140disposed in the elongate body portion122. The first chamber may include an inlet orifice132for receiving an IV fluid. An anti-run-dry membrane134may be disposed on the upper surface126of the elongate body portion122extending over the inlet orifice132. In some embodiments, the anti-run-dry membrane134may be positioned at the inlet such that the IV fluid50, flowing from the IV fluid source (e.g., IV bag10), passes through the anti-run-dry membrane134. The anti-run-dry membrane134may have a plurality of pores, through which the IV fluid50flows, and may be formed of a hydrophilic material that resists passage of air through the pores while allowing liquid to pass through the pores.

In some embodiments, the inlet orifice132may be fluidly coupled to the drip chamber inlet114for receiving the IV fluid50in a first flow condition (illustrated inFIG.4). The first flow condition as defined herein refers to a condition or state in which IV fluid flows in a regular or normal manner from the IV tubing into the drip chamber insert120and out through the drip chamber outlet116without otherwise being blocked, slowed down, reduced, or impeded by the drip chamber insert120.

As depicted, the second chamber140may be disposed in the elongate body portion122and extend from the upper surface126to the base portion124. The second chamber140may have an open proximal end144for receiving at least a portion of the IV fluid50in a second flow condition (illustrated inFIG.5). The second flow condition as defined herein refers to a keep-vein-open condition or state in which the flow rate of the final milliliters (ml) (for example, but not limited to the last 10-60 ml) of IV fluid in the drip chamber110exiting the drip chamber assembly100via the drip chamber assembly outlet orifice128is slowed down, reduced, or impeded so as to keep a vein of the patient open upon depletion of the IV fluid in the IV fluid bag10. To this effect, in some embodiments, the drip chamber insert120may further include a low flowrate orifice150extending from a distal end142of the second chamber140into the base portion124for fluidly coupling the second chamber140with the drip chamber outlet116. In some embodiments, the low flowrate orifice150may have a shape configured to slow down or otherwise reduce the rate at which the IV fluid passes from the drip chamber assembly into the drip chamber assembly outlet orifice128. For example, in some embodiments, the low flowrate orifice150may have a conical shape which tapers or otherwise reduces in diameter or cross-section distally into the base portion124, towards the outlet116.

For example, in some embodiments, the normal fluid pathway may deliver the fluid at a flow rate ranging from about 50 milliliters/hour (ml/hr) to about 1000 ml/hr, in some instances ranging from about 200 ml/hr to 800 ml/hr, more typically from about 400 ml/hr to 600 ml/hr, and in some embodiments approximately 500 ml/hr. In contrast, in some embodiments, the KVO fluid pathway may deliver the fluid at the reduced or slowed-down flow rate ranging from about 2 ml/hr to about 10 ml/hr, in some instances ranging from about 3 ml/hr to 9 ml/hr, more typically from about 5 ml/hr to 7 ml/hr, and in some embodiments approximately 6 ml/hr. As a further example, in some embodiments, the KVO fluid pathway may deliver the fluid at a slower or reduced rate in the range of about 1% to 15% of the flow rate through the normal fluid pathway, in some instances in the range of about 2% to 10% of the flow rate through the normal fluid pathway, more typically from about 3% to 5% of the flow rate through the normal fluid pathway, and in some embodiments approximately 4% of the flow rate through the normal fluid pathway. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific angles, within this full range or any specifically recited range.

According to various embodiments of the present disclosure, the elongate body portion122may further include a sidewall123longitudinally extending between the upper surface126and the base portion124. In particular, the sidewall123may extend from the upper surface126to a proximal end125of the base portion124. As depicted, the elongate body portion122may further include a fluid bypass orifice129disposed in the sidewall123. The fluid bypass orifice129may be fluidly coupled to the drip chamber outlet116via the low flowrate orifice150and the drip chamber insert outlet orifice128.

FIG.4illustrates a perspective view of the drip chamber110and drip chamber insert120ofFIG.3in the first flow condition, in accordance with some embodiments of the present disclosure. As depicted, the inlet orifice132, the first chamber130, the drip chamber insert outlet orifice128and the drip chamber outlet116may be fluidly coupled to define a first fluid pathway160. In operation, IV fluid50flows from the fluid source (e.g., the primary intravenous (IV) fluid bag10) into the drip chamber110. So long as the fluid in the drip chamber110remains above a predetermined fluid level, the first flow condition is activated and the IV fluid50exits the drip chamber assembly100via the first fluid pathway160. In some embodiments, the predetermined fluid level may be greater than or equal to 60 ml. However, the various embodiments of the present disclosure are not limited to this configuration. For example, in some embodiments, the predetermined fluid level may range from about 10-60 ml, in some instances range from about 20-50 ml, in other instances from about 30-40 ml, and in some embodiments approximately 35 ml. In some embodiments, a volume of the drip chamber insert120may range from about 2-10 ml. In yet other embodiments, where a burette may be used in place of the drip chamber insert, a volume capacity of the burette may be as high as up to 150 ml. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific angles, within this full range or any specifically recited range.

In accordance with various embodiments of the present disclosure, in the first flow condition where IV fluid in the drip chamber110is above a predetermined level, the IV fluid flowing from the IV bag10into the drip chamber assembly100passes through the anti-run-dry membrane134and enters the first chamber130via the inlet orifice132. In some embodiments, the predetermined level may be defined as the height at which the anti-run-dry membrane134is positioned. As depicted inFIG.4, in the first flow condition, the IV fluid flows in the first fluid pathway160in a uniform continuous unrestricted/unconstrained manner through the first chamber130and into the IV tubing116via the drip chamber insert outlet orifice128and out of the drip chamber outlet116. Accordingly, the IV fluid may be timely and continuously infused to a patient for example in the first flow condition (e.g., a standard infusion operation). In operation, as the infusion of the IV fluid continues, the IV fluid in the IV bag10may be depleted thereby causing a corresponding decrease of the level of IV fluid in the drip chamber110as the fluid continues to be dispensed into the IV tubing116. When the level of the IV fluid in the drip chamber110falls below the predetermined level, for example, but not limited to between 10 ml to 60 ml, the anti-run-dry membrane134as positioned over the inlet orifice132may enable a fluid column of significant length to be maintained within the first chamber130and the IV tubing116after cessation of flow of the IV fluid50from the IV bag10into drip chamber110, without permitting further IV fluid50to flow into the first chamber130.

In particular, in operation, once the IV fluid50stops flowing into the drip chamber110, for example, due to depletion of the IV fluid50in the IV fluid bag10, and the level of IV fluid in the drip chamber110falls below the predetermined level (e.g., the height at which the anti-run-dry membrane134is positioned), the anti-run-dry membrane134may act to restrict motion of IV fluid50into the inlet orifice132. For example, the anti-run-dry membrane134may have a plurality of pores, each of which has a size that causes the formation of a meniscus of the IV fluid50underneath the anti-run-dry membrane134. Each meniscus may, via capillary action, contribute to the support of a column of the IV fluid50in the first chamber130and IV tubing116. The anti-run-dry membrane134may thus be designed to facilitate support of the column of the IV fluid50within the first chamber130. In some embodiments, the anti-run-dry membrane may become saturated by means of the capillary action. In this condition, the pores of the anti-run-dry membrane134may become filled with fluid thereby providing increased resistance to flow of the IV fluid remaining in the drip chamber110into the first fluid pathway160. Accordingly, in this second flow condition the anti-run-dry membrane134may serve to block the first fluid pathway160to the IV fluid remaining in the drip chamber110.

FIG.5illustrates a perspective view of the drip chamber110and drip chamber insert120ofFIG.3in the second flow condition, in accordance with some embodiments of the present disclosure. As depicted, the open proximal end144of the second chamber140, the low flowrate orifice150, the drip chamber insert outlet orifice128, and the drip chamber outlet116may be fluidly coupled to define a second fluid pathway162. As further depicted, a third fluid pathway164may be defined longitudinally between the sidewall123of the elongate body portion122and the inner surface119of the drip chamber110, through the fluid bypass orifice150, and into the drip chamber insert outlet orifice128and the drip chamber outlet116via the low flowrate orifice150. In some embodiments, a fourth fluid pathway166may be defined longitudinally between the sidewall123of the elongate body portion122and the inner surface119of the drip chamber110, and circumferentially along an upper surface125of the base portion122between the sidewall123of the elongate body portion122and the inner surface119of the drip chamber110, through the fluid bypass orifice129, and into the outlet orifice128via the low flowrate orifice.

According to various embodiments of the present disclosure, the second, third, and fourth fluid pathways162,164and166may collectively define a keep-vein-open fluid path in the second flow condition. In particular, as described above, when the IV fluid in the drip chamber falls below the predetermined level (e.g., the height at which the anti-run-dry membrane134is positioned) the anti-run-dry membrane134may prevent the remaining IV fluid from flowing into the drip chamber assembly outlet orifice128via the inlet orifice such that the remaining IV fluid flows through the second, third, and fourth fluid pathways162,164and166defining the keep-vein-open fluid path having less resistance to flow than the obstructed first fluid pathway.

The aforementioned configuration of the drip chamber assembly having the drip chamber insert as described above is advantageous in that drip chamber insert120may be fixed (for example, welded or glued) into the drip chamber110functions to slow down the final milliliters (for example, but not limited to, the last 10-60 ml) of IV fluid in the drip chamber110. This slowing towards the end of the infusion allows the patient's vein to stay open longer until a clinician can tend to the finished infusion. The drip chamber insert120may split the drip chamber into two chambers; the first chamber for normal flow, and the second chamber with the low flowrate orifice at the bottom that allows for a greatly reduced flow rate as compared to the flowrate through the first chamber in the first flow condition (i.e., standard infusion flow). The anti-run-dry filter134attached to the top of the inlet orifice132(also referred to herein as the normal flow orifice) ensures that when the IV fluid in the drip chamber is low enough, the first fluid pathway160is stopped and the KVO fluid pathway162,164, and166has less resistance to fluid flow, thereby allowing the IV fluid to be administered to the patient via the outlet116at low flow rates sufficient to just keep the vein open.

Accordingly, the various embodiments of the present disclosure are advantageous in providing a drip chamber assembly capable of dispensing the last few milliliters of IV fluid to a patient at a reduced flow rate in order to keep the vein open once the IV fluid in the IV bag is depleted. The drip chamber assembly with drip chamber insert of the various embodiments described herein is further advantageous as it does not require modifications to the existing drip chamber other than affixing the drip chamber insert therein, thus only minimal change to the currently existing IV sets is made. As can be appreciated, no modifications to the pump are required. Further advantageously, the drip chamber insert does not require complex electronics or other technology in order to be integrated into the currently existing drip chamber. The drip chamber insert is a mechanical device with mechanical connection. Additionally, the drip chamber assembly with drip chamber insert of the various embodiments described herein is advantageous in that no additional training required to use it. Further advantages are realized in time savings with respect to infusion therapy time for the medical personnel by eliminating the need to reinsert the catheter due to blood coagulation, which is commonly associated with gravity sets or pumps that do not have a keep-vein-open (KVO) function. Furthermore, since the catheter does not need to be reinserted, the drip chamber insert can reduce or otherwise eliminate pain to the patient associated with reinserting the catheter.

The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent.

As used herein, the phrase “at least one of” preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrase “at least one of A, B, or C” may refer to: only A, only B, or only C; or any combination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa.

In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, 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. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims 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.

All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

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 of the 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.