Low flow percussive respiratory apparatus and related treatment

Abstract

A valve assembly attached to a capacitor such that pressurizing the capacitor to a first positive pressure threshold induces the valve assembly to open, the pressurized air is released to the patient, and then as the pressure in the capacitor drops to a second pressure threshold the valve closes and the capacitor begins to build pressure until the first positive pressure threshold is achieved and the process repeats. Relative to the valve assembly and integrated therein, is an incrementally adjustable index knob to vary the rate of a biasing force performing work against the actionable valve face of the diaphragm functional surface to set the performance of the valve assembly, thereby increasing the potential for correct operation across a range of oscillating rates supporting a broad spectrum of patient therapies and types.

Claims

1. A percussive respiratory apparatus, comprising: a pneumatic valve assembly having a housing, a diaphragm positioned in the housing that moves between a first position and a second position, a first fluidic communication port, wherein the diaphragm abuts and closes the fluidic communication port when in the first position and is spaced from the first fluidic communication port in the second position, and a second fluidic communication port spaced from the first fluidic communication port; a biasing member positioned on a first side of the diaphragm and applying a force on the diaphragm to move the diaphragm from the second position to the first position; an adjustable knob associated with the biasing member to vary the force applied by the biasing member on the diaphragm; a gas receiving chamber in fluidic communication with the first fluidic communication port; a patient interface in fluid communication with the second fluidic communication port, wherein the patient interface includes a divided lumen having at least a first pathway adapted to provide an inhalation fluid and at least a second pathway adapted to channel exhalation fluid away from a patient; wherein when the diaphragm moves from the first position gas within the gas receiving chamber moves through the first and second fluidic communication ports to the patient interface through at least the first pathway, when the diaphragm is in the first position, no gas exits the receiving chamber, and at least the second pathway is configured to receive gas exhaled from a patient.

2. The apparatus of claim 1, wherein said receiving chamber is a pneumatic capacitor and has a dynamic variable response.

3. The apparatus of claim 1, wherein the adjustable knob allows for finite control of the movement of the diaphragm to create an oscillating movement in terms of frequency of cycling, amplitude of each cycle, and the combinations thereof.

4. The apparatus of claim 1, wherein the diaphragm exhibits a complete cycling rate of between about 1 and about 100 cycles per minute when provided pressurized gas at a flow rate of between about 8 and about 30 liters per minute.

5. The apparatus of claim 1, wherein the diaphragm exhibits a cycling rate when the gas receiving chamber is provided pressurized gas at a pressure of between about 8 and about 20 cm-water.

6. The apparatus of claim 1, wherein the diaphragm exhibits a cycling rate when provided pressurized gas at a flow of between about 8 and about 30 liters per minute.

7. The apparatus of claim 1, further comprising an entrainment valve assembly in fluid communication with the gas receiving chamber, and having a third fluidic communication port drawing fluid into the entrainment valve assembly from a source external to the entrainment valve assembly.

8. The apparatus of claim 7, wherein said entrainment valve creates a negative pressure which induces additional fluid to be draw into the apparatus.

9. The apparatus of claim 8, wherein a ratio of pressurized fluid to volume of fluid drawn in by the third fluidic communication port is between about 10:90 to about 90:10.

10. The apparatus of claim 1, further comprising a nebulizer assembly in fluid communication with the patient interface.

11. The apparatus of claim 10, wherein the patient interface is repositionable to allow the nebulizer assembly to be repositioned relative to the apparatus itself.

12. The apparatus of claim 11, wherein the patient interface includes a fourth fluidic communication port for operative association with the nebulizer assembly, and wherein repositioning the patient interface repositions the fourth fluidic communication port.

13. The apparatus of claim 1, wherein the at least one second pathway comprises at least one ventilation port.

14. The apparatus of claim 1, wherein the at least first and at least second pathways are in symmetrical orientation as viewed in cross-section of the divided lumen.

15. The apparatus of claim 7, wherein the entrainment valve assembly, comprises: (a) a pressurized fluid source; (b) an entrainment gas inlet port; (c) an entrainment jet; (d) the third fluidic communication port; (e) a secondary fluid source; and (f) an entrainment outlet port; (g) wherein the pressurized fluid source flows through the entrainment gas inlet port and into the entrainment jet, wherein the entrainment jet imparts a laminar flow on the pressurized fluid, wherein the laminar flow of pressurized fluid leaves the entrainment valve assembly through the entrainment outlet port, wherein the laminar flow creates a negative pressure proximal to the entrainment jet and before the entrainment outlet port, and wherein the negative pressure causes fluid to be drawn in through the secondary inlet port and to become entrained into the laminar flow of the pressurized fluid source.

16. The apparatus of claim 15, wherein the entrainment valve assembly further comprises an indexing element, wherein the indexing element allows for the ratio of entrainment of secondary fluid source to said pressurized fluid source to be finitely controlled.

17. The apparatus of claim 16, wherein the indexing element circumscribes the entrainment jet.

18. The apparatus of claim 16, wherein the indexing element ranges from fully closed to fully open in about 270 degrees or less rotation about the entrainment jet.

19. The apparatus of claim 15, wherein the pressurized fluid and said secondary fluid source leave the entrainment valve assembly as an essentially homogenous fluid mixture.

20. The apparatus of claim 15, wherein the secondary fluid source is ambient air.

Description

DESCRIPTION OF THE DRAWING

(1) The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the general description of the invention given above and the detailed description of the drawings given below, serve to explain the principles of these inventions.

(2) FIG. 1A is a plan view of a percussive respiratory device as shown and described in U.S. Pat. No. 6,067,984.

(3) FIG. 1B is a reproduction of FIG. 1A with fluid flow paths added for purposes of explanation.

(4) FIG. 2 is a perspective view of one embodiment of a percussive respiratory device according to aspects of the present disclosure.

(5) FIG. 3 is an exploded view of the device of FIG. 2.

(6) FIG. 4 is a cross-sectional view of the embodiment of FIG. 1, with the nebulizer assembly omitted.

(7) FIG. 5 is an enlarged cross-sectional view of an alternative embodiment of a pneumatic capacitive assembly for use in a percussive respiratory device.

(8) FIG. 6A is cross-sectional view of a representative diaphragm valve including a rigid center piece and a connecting web.

(9) FIG. 6B is a magnified cross-sectional view of a representative diaphragm valve as depicted in FIG. 6A, including a rigid center piece and a connecting web.

(10) FIG. 7 is a perspective cross-sectional view of the embodiment of FIG. 5, with the diaphragm valve in a closed position.

(11) FIG. 8 is a perspective cross-sectional view of the embodiment of FIG. 5, with the diaphragm valve in an open position.

(12) FIG. 9 is a perspective view of the embodiment of FIG. 5, with a nebulizer assembly attached to the underneath or lower side of the patient mouthpiece.

(13) FIG. 10 is a perspective view of the embodiment of FIG. 5, with the patient mouthpiece rotated 180 degrees and separated from the pneumatic valve assembly compared to FIG. 9, such that a nebulizer assembly may be connected to the top or upper side of the mouthpiece.

(14) FIGS. 11A-C are alternative embodiments of a patient mouthpiece with a dual lumen.

(15) FIG. 12 A is a perspective view of one embodiment of an entrainment device.

(16) FIG. 12B is an elevation view of the embodiment of FIG. 12A.

(17) FIG. 12C is a cross-sectional view of the embodiment of FIG. 12B.

(18) While the following disclosure describes the invention in connection with those embodiments presented, one should understand that the invention is not strictly limited to these embodiments. Furthermore, one should understand that the drawings are not necessarily to scale, and that in certain instances, the disclosure may not include details which are not necessary for an understanding of the present invention, such as conventional details of fabrication and assembly.

DETAILED DESCRIPTION

(19) Turning to FIGS. 2 and 3, one embodiment of a percussive respiratory device 200 according to aspects of the present disclosure is illustrated. The device 200 includes a pneumatic valve assembly 202, a patient port or mouthpiece 204, a waste or water trap 206, an optional nebulizer assembly 208 and a stand 210 for hands free use. A gas inlet port 212 supplies pressurized gas to the pneumatic valve assembly 202 and a gas inlet port 214 separately supplies pressurized gas to the nebulizer assembly 208.

(20) The valve assembly 202 comprises a valve top 216, a valve bottom 218, a capacitor 220 and a pneumatically movable valve in the form of a diaphragm 222. The valve assembly 202 further includes a pressure modulator apparatus 224 that includes an adjustable pressure knob 226 rotatably connected to a pressure boss 228. A snap ring 230 may be used to lockably interconnect the knob 226 to the boss 228 to prevent removal of the knob. A compression spring 232 is disposed between the snap ring 230 and the diaphragm 222 and applies downward pressure on the diaphragm 222. A spring spacer 234 may be used to maintain the position of a first end of the spring 232 relative to the snap ring 230 and a washer 236 may secure the opposite end of the spring 232. A connector body 240 extends outwardly from the capacitor 220 for engaging the stand 210. As illustrated, the stand 210 comprises a cylindrical post which nests within connector body 240 to secure the percussive respiratory device in a hands-free position.

(21) A patient mouthpiece 204 extends laterally from and is in fluid communication with the pneumatic valve assembly 202. A port 250 extends downwardly from the bottom wall 252 of the mouthpiece 204. A water or waste trap 206 is connected to the port 250 and collects fluids released or exhaled by the patient. The nebulizer assembly 208 is also in fluid communication with the mouthpiece 204 via the port 250. In one embodiment, the nebulizer assembly 208 includes male port 254 that extends through the water trap 206 and concentrically interfaces with mouthpiece port 250, allowing for exhaled body fluids to bypass the nebulizer assembly and be captured by the trap 206. The trap 206 and nebulizer assembly are removable for replacement or cleaning. The nebulizer assembly 208 includes an upper housing 260, lower housing 262 and an orifice assembly 264 with a baffle 266. As is known in the art, a liquid is placed in the nebulizer housing and compressed air or oxygen is streamed through the orifice assembly 264 to create an aerosol for inhalation by a patient. The liquid placed in the housing may optionally include a medicine for treatment of the patient or may add moisture to gas supplied to the patient.

(22) Turning to FIG. 4, a cross-section of one embodiment of a percussive respiratory device according to the present disclosure is shown. The knob 226 includes a cylindrical inner wall 270 with exterior threads 272 that interface with complimentary threads 274 on the interior of boss 228. The cylindrical inner wall 270 further includes an inwardly projecting annular lip 276 that engages the top end of the spring 232. Rotating the knob 226 clockwise or counterclockwise compresses or decompresses the spring 232 to alter the pressure applied to the diaphragm 22. By adjusting the pressure applied to the upper surface of the diaphragm, the pressure opposing the opening of the diaphragm valve, the diaphragm 22 is caused to cycle at a variety of frequencies and amplitudes, thus providing a different type of ventilatory effect and therapeutic performance on the patient via the mouthpiece 204 which is in constant fluid communication with the capacitor 220 of the percussive respiratory device. Although the connection between the threads 272 and 274 is a continuous helical thread arrangement, it will be appreciated by those of skill in the art upon review of the present disclosure that other arrangements may be utilized, for example, discontinuous threads, slot and notch sliding tabs, or other such mechanisms known in the art for allowing two bodies to be affixed and adjusted in situ, and such other mechanisms are deemed within the scope of this disclosure.

(23) In one embodiment, the position of the knob 226 may be continuously adjustable to provide continuous adjustment of the pressure applied by spring 232. Alternatively, the snap ring 230 may optionally include a suitable locking or ratchet mechanism, such as a flexible tab or spring-loaded indent, which acts upon incremental notches within the knob 226 so as to either induce a pause or requirement for additional torsion by the user to cause the knob 226 to index to the next preceding notch (either based on increasing or decreasing the compression of biasing spring 232). The notch profile may also be terminal in nature such that under normal torsion loads the knob 226 and snap ring 230 cannot be indexed further (such as at the minimum or maximum settings of the knob 226). The incremental adjustment for adding or subtracting torsion by the user allows for a percussive respiratory device 10 to be set consistently at a predefined level of therapeutic performance.

(24) As also seen in FIG. 4, the capacitor 220 has an outer wall 280, a lower wall 282 and an upper wall 284 that define a cavity 286. The gas inlet port 212 is in fluid communication with the cavity 286. A primary port 290 is formed in the upper wall 284. In this embodiment, the port 290 is generally cylindrical in shape but may have any cross-sectional shape. The port 290 includes an upper surface 292 which interfaces with the lower surface 294 of the diaphragm 222. A secondary chamber 296 is defined by the interior of the valve top 216 and the upper wall 284 of the capacitor 220. The secondary chamber 296 is in continuous fluid communication with the interior of the patient mouthpiece 204 via port 298 in the side wall of the valve top 216.

(25) Turning to FIGS. 5-8, the operation of one embodiment of the pneumatic valve assembly 202 according to aspects of the present disclosure will be described. The diaphragm 222 is generally cylindrical in shape with an outer wall 300 that abuts an inner surface 302 of the valve top 216 and forms a seal or fluid barrier. The diaphragm 222 further includes a central body portion 304 having an upper surface 306 and a lower surface 294. The upper surface interfaces with spring 232 and a portion of the lower surface 294 abuts the upper surface 292 of the primary port 288. The central body portion 304 comprises a disk 308 that is received in a channel or groove 310 formed in an annular ring 312. A flexible membrane 314 extends between the annular ring 312 and an inwardly projecting lip 316 formed on the inside of the outer wall 300. The flexible membrane 314 has a size and shape that allows the central body portion 304 to move linearly between an upper or open position and lower or closed position relative to outer wall 300 which is fixed and non-movable once installed. In cross-section the flexible member 314 is generally semi-circular but other shapes or sizes that allow the central portion 304 to move relative to the stationary outer wall 33 are within the scope of this disclosure.

(26) FIG. 7 illustrates the pneumatic valve assembly 202 in a closed position and FIG. 8 illustrates the valve assembly 202 in the open position. With reference to FIG. 7, the lower surface 294 of the central portion 304 of the diaphragm 222 abuts the upper surface 292 of the primary port 288 of the capacitor 220. The port 298 in the side wall of the valve top 216 is open to the mouthpiece 204 but the diaphragm 222 is blocking the port 288 due to the force applied against the upper surface 306 of the central portion 304 of the diaphragm 222 by the spring 232. Because gas is being continuously supplied to the capacitor cavity 286 through inlet port 212 the pressure within the cavity 286 builds. At some level, the pressure inside cavity 286 overcomes the force applied by the spring 232 and the central portion 304 of the diaphragm is forced up and away from the upper surface 292 of the port 288. As illustrated in FIG. 8, the flexible portion 314 of the diaphragm 222 is deformed to accommodate the movement of the central portion 304 from the closed to the open position. The central portion 304 will move from the open to the closed position upon the gas pressure within the cavity 286 decreasing below the pressure applied by the spring 232. Once the diaphragm moves to the closed position, pressure within the cavity 286 will again increase and the cycle will repeat itself. The frequency and amplitude of the movement of the diaphragm is dependent upon the pressure applied by the spring 232, which is adjustable, and the pressure of the incoming gas supply. Thus, trained personnel may adjust the frequency and amplitude of the gas supplied to a patient to achieve desired medical objectives.

(27) In one embodiment, the diaphragm 222 exhibits a complete cycling rate of between about 1 and about 100 cycles per minute and more preferably a cycling rate of between about 10 and about 20 cycles per minute. According to aspects of the present disclosure, the diaphragm exhibits a cycling rate when provided pressurized air, oxygen or mixtures thereof at a pressure of between about 8 and about 20 cm-water and more preferably a cycling rate when provided pressurized air, oxygen or mixtures thereof at a pressure preferably between about 10 and about 18 cm-water. According to aspects of the present disclosure, the diaphragm exhibits a cycling rate when provided pressurized air, oxygen or mixtures thereof at a flow of between about 8 and about 30 liters per minute and more preferably a flow of preferably between about 10 and about 25 liters per minute.

(28) FIGS. 9-10 illustrate the reversible nature of the mouthpiece 204 according to aspects of the present disclosure. The mouthpiece is generally symmetrically designed such that the port 250 may be oriented on the bottom (FIG. 9) or the top (FIG. 10). In turn, this provides flexibility when utilizing nebulizers. Some nebulizers are designed for a bottom position, for example, VixOne nebulizer sold by Westmed, Inc., Tucson, Ariz. And other nebulizers, for example, Aerogen Solo manufactured by Aerogen, Galway, Ireland are designed for a top or upper position. A friction fit connection scheme allows the mouthpiece 204 to be secured to the outer wall of the valve top 216 in either orientation. Stepped shoulders 320 and 322 protrude or extend from the side wall of the valve top 216. These shoulders are positioned within a protruding perimeter wall 324 and a channel 326 is formed between the perimeter wall 324 and the shoulders 320 and 322. In contrast, the open end of the mouthpiece 204 that mates with the valve top 216 comprises a perimeter edge or lip 328 and an inner shoulder 330 as best seen in FIGS. 7 and 8.

(29) Another feature of a percussive respiratory device according to aspects of the present disclosure is the multiple pathway or multiple lumen design of the mouthpiece 204. As seen in FIG. 10, for example, the mouthpiece 204 has a proximal body portion 332 that interfaces with a patient and a distal body portion 334 that interfaces with the valve assembly 202. The proximal body portion 332 is reduced in overall size relative to the distal body portion 334 to ergonomically accommodate and interface with the mouth of a patient. As seen in FIGS. 11A-C, the proximal end 332 of the mouthpiece 204 includes multiple fluid flow pathways or lumens. A first lumen 340, centrally located, delivers input gas to the patient. One or more second lumens 342, located outside or peripheral to the central lumen 340, transport exhalation from a patient and vent it to atmosphere. As illustrated in FIGS. 7 and 8, the outer lumens 342 form a channel 344 along the interior of the proximal body portion 332. In the embodiment of FIG. 11A, an exit hole or port 348 in the proximal body portion 332 is in fluid communication with each outer lumen 342 and provides an exit path to atmosphere for exhalation. As illustrated in FIG. 11B, a slot 348 optionally may be formed in the proximal body portion 332 in fluid communication with the channel 344 to allow exhalation to exit the mouthpiece. In FIGS. 11A and 11B, the outer lumens 340 are oriented in opposite corners of the proximal body portion 332. In the embodiment of FIG. 11C, the lumens are oriented on opposite sides of the proximal body portion 332. It should be appreciated that the outer lumens may comprise other shapes than illustrated, that there may be one, two, three or more outer lumens and the outer lumens need not be positioned at the outer perimeter of the proximal body portion 332. For example, outer lumen(s) 342 may be oriented on one side of the proximal body portion 332 and the inhalation lumen 340 oriented on the opposite side. The single input lumen 340 may also comprise multiple lumens. In addition, the walls of the lumens may be configured by shape, orientation and/or surface texture to create with turbulence or laminar flow of the input gas and exhalation to optimize treatment for any given patient.

(30) In operation, a patient receives treatment of a fluidic source through the first lumen, with the first lumen being of a size and geometry so as to not create an excessively high flow or pressure of the fluid which might cause undue physiological harm. Upon exhalation or exhaust of the fluid from the patient, the fluid is directed through the second lumen and away from the patient via an exteriorly associated exhalation port 346 or slot 344. The exhalation port or slot may be in direct communication with the ambient environment of the patient, or may route through a secondary process, such as a gas scavenging system or a filter, so as to reclaim or extraction one or more fractions of the exhaust flow. It is within the prevue of the present disclosure that the first and second lumens may be in a circumferential, “side by side”, or alternate relationship, and that either or both lumens may have the same or different geometries, and may be further divided into one or more secondary routings or sublumens that provide the same or alternate flows of the same or different fluidic sources.

(31) A further element of the present invention comprises a variable entrainment valve assembly 450 illustrated in FIGS. 12A-C. The entrainment valve assembly 450 includes an entrainment gas inlet port 456 where by a pressurized fluid source in connected, for example, an air compressor or pressurized oxygen tank (not shown). Pressurized fluid is conducted through the inlet port 456 and through an entrainment jet 458. The entrainment jet 458 imparts a laminar flow to the pressurized fluid whereby it is conducted into a entrainment outlet port 452. According to aspects of the present disclosure, in at least one embodiment, outlet port 452 is in fluid communication with an inlet port of a percussive respiratory device, for example port 212 shown in FIG. 2. As the laminar flow is conducted from the inlet port 456 to the outlet port 452, a negative pressure is created proximal to the entrainment jet 458. Fluid is drawn in by the negative pressure through one or more secondary inlet ports 460. The degree of flow through the one or more secondary inlet ports 460 is defined by an entrainment mixing adjustment 454 which engages upon an indexing element 462 exterior to entrainment gas outlet port 452 to allow for finite adjustment. The volume of fluid conducted through the entrainment gas inlet port 456 plus the volume of fluid drawn in by the secondary inlet port 460 are intermixed and ejected as an essential homogenous fluid via the entrainment jet outlet port 452. Gas entrainment valve assembly 450 is designed such that indexing the assembly by rotation of the entrainment mixing adjustment 454 either increases or decreases the volume of atmosphere which can be drawing into the assembly. In one embodiment, the indexing element the indexing element ranges from fully closed to fully open in about 360 degrees or less rotation about said entrainment jet. Alternatively, the indexing element 462 ranges from fully closed to fully open in about 270 degrees or less rotation, or in about 180 degrees or less of rotation, or in about 90 degrees or less of rotation.

(32) Representative relative fluidic mixing ratios include those shown in Table 1.

(33) TABLE-US-00001 TABLE 1 Rotation Angle Travel (in) 25 0.014 45 0.025 90 0.05 135 0.075 225 0.125 270 0.15

(34) According to aspects of the present disclosure, in one embodiment, the entrainment valve 450 exhibits a ratio of pressurized fluid to volume of fluid drawn in by the secondary inlet port of between about 10:90 to about 90:10 and more preferably a ratio of pressurized fluid to volume of fluid drawn preferably in by the secondary inlet port of between about 30:70 to about 70:30. Accordingly, with the entrainment valve operatively connected to a percussive respiratory device, the volume or rate at which compressed gas is supplied to the percussive respiratory device may be decreased without loss of functionality. For example, a percussive respiratory device in combination with a nebulizer typically requires a flow of about 25 to 30 liters per minute (LPM) to function properly. When an entrainment valve of the type described herein, e.g., valve 450, is connected to the inlet port 212 of a capacitor 220, flow requirements can decrease to approximately 10-12 LPM with room air added to the input gas through ports 458. This allows potentially for less consumption of supplied input gas and also increases the use of the percussive respiratory device outside of hospitals, nursing homes and other medical facilities allowing the device to be used in private settings and residences where high flow rate input gas sources are not readily available. Instead, the percussive respiratory device may be used with a smaller compressor capable of satisfying the lower flow rate requirements. Lower flow rate compressors are more readily available, including from most home healthcare companies, are less expensive that high flow rate compressors and are typically covered by private insurance.

(35) It is within the purview of the present invention that the individual components of the percussive respiratory device may be constructed from thermoplastic and/or thermoset polymers, nonferrous metals, ferrous metals, glass, and the combinations thereof. The present invention is not constrained to the mode or method of individual component manufacture, such as by molding or machining, or by the means such components are combined into the apparatus depicted, such as by adhesives (gluing), thermal welding (i.e. ultrasonic), or mechanical retention (screws, interlocking tabs, clasps).

(36) As used herein, the singular terms “a,” “an,” and “the” may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.”

(37) As used herein, the term “set” refers to a collection of one or more objects. Thus, for example, a set of objects can include a single object or multiple objects.

(38) As used herein, the terms “substantially” and “about” are used to describe and account for small variations. When used in conjunction with an event or circumstance, the terms can refer to instances in which the event or circumstance occurs precisely as well as instances in which the event or circumstance occurs to a close approximation. When used in conjunction with a numerical value, the terms can refer to a range of variation of less than or equal to ±10% of that numerical value, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%. For example, “substantially” aligned can refer to a range of angular variation of less than or equal to ±10°, such as less than or equal to ±5°, less than or equal to ±4°, less than or equal to ±3°, less than or equal to ±2°, less than or equal to ±1°, less than or equal to ±0.5°, less than or equal to ±0.1°, or less than or equal to ±0.05°.

(39) Additionally, amounts, ratios, and other numerical values may sometimes be presented herein in a range format. It is to be understood that such range format is used for convenience and brevity and should be understood flexibly to include numerical values explicitly specified as limits of a range, but also to include all individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly specified. For example, a ratio in the range of about 1 to about 200 should be understood to include the explicitly recited limits of about 1 and about 200, but also to include individual ratios such as about 2, about 3, and about 4, and sub-ranges such as about 10 to about 50, about 20 to about 100, and so forth.

(40) Although the description herein contains many details, these should not be construed as limiting the scope of the disclosure but as merely providing illustrations of some of the presently preferred embodiments. Therefore, it will be appreciated that the scope of the disclosure fully encompasses other embodiments which may become obvious to those skilled in the art.

(41) All structural and functional equivalents to the elements of the disclosed embodiments that are known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed as a “means plus function” element unless the element is expressly recited using the phrase “means for”. No claim element herein is to be construed as a “step plus function” element unless the element is expressly recited using the phrase “step for”.

(42) The foregoing Detailed Discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the invention to the form or forms disclosed herein. For example, various features are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the invention.