Devices, methods, and systems for an articulated ankle-foot orthosis with a selectively retractable stop are presented. The orthosis includes at least one of a foot mold, a shank mold, a forefoot sensor, a heel sensor, a stop, and a connecting mechanism. The stop is positioned between the foot mold and the shank mold, and the stop is selectively retractable between a closed position and a generally opposing open position that allows plantar flexion of the foot mold during the stance phase of a typical human gait cycle. The connecting mechanism is configured to move the stop from the closed position to the open position in response to a signal from the heel sensor indicating a heel-strike event. The connecting mechanism is also configured to move the stop from the open position back to the closed position in response to a signal from the forefoot sensor indicating a toe-off event.

BACKGROUND

The following disclosure relates generally to the field of orthoses and, more specifically, to an articulated ankle-foot orthosis controlled by the foot stance of the wearer.

Idiopathic toe walkers describes persons who walk without making heel contact during the initial contact phase of the gait cycle, yet have no signs of neurological, orthopaedic, or psychiatric diseases.

The existing conventional orthosis that is commonly prescribed for idiopathic toe walkers improves heel contact by restricting plantar flexion of the foot (downward rotation of the foot, relative to the ankle). Restricted plantar flexion, however, causes other problems and impedes the development of a normal walking gait. Without plantar flexion during the loading response period of the gait cycle, individuals have a smaller base of support, which limits the stability of their gait. Furthermore, without plantar flexion during the push-off period of the gait cycle, individuals cannot generate sufficient propulsion to advance the body efficiently. These limitations contribute to reports by wearers that the conventional ankle-foot orthosis is uncomfortable, significantly impairs walking, and produces dissatisfactory results. Motorized ankle-foot orthoses offer increased motion control, but are too complicated, expensive, bulky, and heavy for widespread use.

Accordingly, there is a need for improved ankle-foot orthoses that encourage a normal gait while providing stability, efficient propulsion, comfort, and improved clinical results.

SUMMARY

An ankle-foot orthosis, according to various embodiments, comprises at least one of a foot mold, a shank mold, a forefoot sensor, a heel sensor, a stop, and a connecting mechanism. The foot mold can be connected to the shank mold by a flexible connector. The forefoot sensor can be positioned on a sole of the foot mold and near a distal end of the foot mold. The heel sensor can be positioned on the sole and a proximal end of the foot mold. The stop can be selectively positioned between the foot mold and the shank mold. In one aspect, the stop is selectively retractable between a closed position that restricts plantar flexion of the foot mold, and a generally opposing open position that allows plantar flexion of the foot mold. The connecting mechanism can be positioned along a side wall of the foot mold. The connecting mechanism can be configured to move the stop about and between the closed position and the open position in response to at least one signal received from the forefoot sensor and/or the heel sensor. For example, the connecting mechanism can be configured to move the stop from the closed position to the open position in response to a signal from the heel sensor indicating a heel-strike event. In another example, the connecting mechanism can be also configured to move the stop from the open position back to the closed position in response to a signal from the forefoot sensor indicating a toe-off event.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

The following description is provided as an enabling teaching in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects described herein, while still obtaining the beneficial results of the technology disclosed. It will also be apparent that some of the desired benefits can be obtained by selecting some of the features while not utilizing others. Accordingly, those with ordinary skill in the art will recognize that many modifications and adaptations are possible, and may even be desirable in certain circumstances, and are a part of the invention described. Thus, the following description is provided as illustrative of the principles of the invention and not in limitation thereof.

As used throughout, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component can include two or more such components unless the context indicates otherwise. Also, the words “proximal” and “distal” are used to describe items or portions of items that are situated closer to and away from, respectively, a user or operator. Thus, for example, the tip or free end of a device may be referred to as the distal end, whereas the generally opposing end or far end may be referred to as the proximal end.

As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. As used herein, the term “facilitate” means to make easier or less difficult and the term “impede” means to interfere with, hinder, or delay the progress.

Although the various embodiments are described with reference to a human ankle and foot, the assemblies and methods described herein can be used with any of a variety of joints and in other vertebrates.

Plantar flexion is a downward rotation of the foot relative to the ankle. Dorsiflexion is an upward rotation of the foot. Plantar flexion and dorsiflexion are illustrated inFIG. 1. The shank is that part of the leg between the ankle and the knee in humans, or a corresponding part in other vertebrates.

FIG. 1is an illustration of a two-part articulated ankle-foot orthosis100according to various embodiments. The orthosis100can comprise a foot mold120configured to be worn on at least a portion of the foot of a user, and a shank mold180configured to be worn on at least a portion of the leg of a user. In one aspect, the foot mold and the shank mold can be connected together but separated from each other by a predetermined distance. That is, an upper portion125of the foot mold120can be spaced from a lower portion185of the shank mold a predetermined distance such that a gap190is defined between the foot mold and the shank mold. In another aspect, the foot mold120and the shank mold180can be connected together by a connector150. For example, the connector can be a flexible connector.

In one aspect, the foot mold120can be sized and shaped to create a bed for a foot of a user. Optionally, the foot mold can be sized and shaped to create a bed for feet of a variety of shapes and sizes, or the foot mold can be custom-made. With reference toFIGS. 1 and 3, the foot mold can comprise a sole130configured to engage a walking surface or the shoe of a user, a longitudinal axis LF, a proximal end140configured to be positioned adjacent the heel of a user when the orthosis is worn, and an opposed distal end160configured to be positioned adjacent the toe of a user when the orthosis is worn. In a further aspect, the shank mold180can be sized and shaped to engage a leg of the user. Optionally, the shank mold can be sized and shaped to engage legs having a variety of shapes and sizes, or the shank mold180can be custom-made. The shank mold can have a longitudinal axis LSas illustrated inFIGS. 1 and 3.

Referring toFIG. 2, the human gait can be described using a number of phases or events, as shown. The stance phase30begins with an initial contact or heel strike on the walking surface. The stance phase30ends at toe-off; the event during which the toe leaves the ground and begins the swing phase40. The swing phase40ends at the next heel strike.

As described more fully below, the orthosis100allows a user plantar flexion during the stance phase30which facilitates normal ankle rotation and improves stability and propulsion power. In one aspect, the orthosis100can allow normal ankle rotation, with plantar flexion, during the stance phase. Thus, in the stance phase30, the orthosis can allow the user to selectively alter the angle formed between the longitudinal axis LFof the foot mold and the longitudinal axis LSof the shank mold as desired. During the swing phase40, however, when the foot is in motion above the walking surface, the orthosis100can limit ankle rotation in order to facilitate a proper heel strike. That is, in the swing phase, the orthosis100can prevent or restrict the user from selectively altering the angle formed between the longitudinal axis LFof the foot mold and the longitudinal axis LSof the shank mold beyond a predetermined angle.

With reference again toFIG. 1, in one aspect, the orthosis100comprises at least one of a heel sensor400, a forefoot sensor500, a stop200(positioned between the foot mold120and the shank mold180), and a connecting mechanism300such as a linkage to connect at least a portion of these elements. In another aspect, the connecting mechanism can respond mechanically to changes in the heel and forefoot sensors400,500during walking. The connecting mechanism300is shown schematically in order to illustrate the existence of connections between the heel sensor400, the forefoot sensor500, and the stop200. As more fully described herein, the connecting mechanism300can comprise a variety of components.

The stop200, as shown inFIG. 1, can restrict plantar flexion when “closed” or “in place” between the foot mold120and the shank mold180. In use and as described more fully below, the stop200can restrict motion between the foot mold120relative to the shank mold180. That is, the stop can prevent or restrict rotation of the longitudinal axis LFof the foot mold relative to the longitudinal axis LSof the shank mold. In operation, therefore, the connecting mechanism300can be configured to respond to changes in the heel and/or the forefoot sensors400,500and either open or close the stop200. When opened, the stop200can be retracted or otherwise withdrawn from the space between the foot mold and the shank mold180. For example, the connecting mechanism300can facilitate opening of the stop200during the stance phase30, and closing of the stop200during the swing phase40.

FIG. 3is a schematic illustration of the orthosis100, according to one aspect. In this aspect, the orthosis100comprises the heel sensor400, the forefoot sensor500, the stop200, and the connecting mechanism300. The connecting mechanism couples the heel sensor, the forefoot sensor, and the stop200together such that position changes in the heel and forefoot sensors400,500produce a desired position change in the stop200. In another aspect, the connecting mechanism300can operate mechanically without motors or powered actuators.

In one aspect, the heel sensor400comprises a heel pedal410mounted on the sole130of the foot mold120near or adjacent to the heel or proximal end140of the foot mold. In another aspect, a first end430of the heel pedal can be coupled to the foot mold, and a second end440of the heel pedal410can be spaced from the first end. In still another aspect, the heel sensor can be biased about and between a closed heel position, in which the first end and the second end of the heel pedal are substantially adjacent to the sole of the foot mold, and an open heel position, in which one of the first end430and the second end440of the heel pedal410is spaced from the sole130.

The heel pedal410can be hingedly attached to a portion of the foot mold, according to one aspect. In another aspect, the heel sensor400can be biased toward the open position by a heel spring420configured to urge the heel sensor400open when the heel spring is in a first, expanded position. That is, when the heel spring420is in the first, expanded position, the heel sensor can be open such that one of the first end430and the second end440of the heel pedal410can be spaced from the sole130of the foot mold120a predetermined distance. In one aspect, the heel spring can be located adjacent the heel sensor. For example and without limitation, the heel spring420can be positioned around the first end430of the heel sensor, or directly positioned against the heel pedal. Optionally, the heel spring420can be positioned in any position that urges the heel sensor400open when the heel spring is in the first, expanded position.

In one aspect, the heel sensor400can be positioned on the sole130of the foot mold120such that when the heel sensor is open, the first end430of the heel pedal410can be coupled to the foot mold, and the second end440of the heel pedal can be spaced from the sole of the foot mold a predetermined distance. That is, in this aspect, the heel sensor can open towards the distal end160of the orthosis, as illustrated inFIG. 3. Optionally, in another aspect, the heel sensor400can be positioned on the sole130of the foot mold120such that when the heel sensor is open, the second end440of the heel pedal410can be coupled to the foot mold, and the first end430of the heel pedal can be spaced from the sole of the foot mold a predetermined distance. That is, in this aspect, the heel sensor can open towards the proximal end140of the orthosis instead of towards the distal end160, as illustrated inFIG. 3. It is also contemplated that the heel sensor400can be any type of sensor or switch capable of sensing changes in the position of the heel of the user.

In one aspect, the forefoot sensor500comprises a forefoot pedal510mounted on the sole130of the foot mold120near or adjacent to the toe or distal end160of the foot mold. In another aspect, a first end530of the forefoot pedal can be coupled to the foot mold, and a second end540of the forefoot pedal510can be spaced from the first end. In still another aspect, the forefoot sensor can be biased about and between a closed forefoot position, in which the first end and the second end of the forefoot pedal are substantially adjacent to the sole of the foot mold, and an open forefoot position, in which one of the first end530and the second end540of the forefoot pedal510is spaced from the sole130.

The forefoot pedal510can be hingedly attached to a portion of the foot mold, according to one aspect. In another aspect, the forefoot sensor500can be biased toward the open position by a forefoot spring520configured to urge the forefoot sensor500open when the forefoot spring is in a first, expanded position. That is, when the forefoot spring520is in the first, expanded position, the forefoot sensor can be open such that one of the first end530and the second end540of the forefoot pedal510can be spaced from the sole130of the foot mold120a predetermined distance. In one aspect, the forefoot spring can be located adjacent the forefoot sensor. For example and without limitation, the forefoot spring520can be positioned around the first end530of the forefoot sensor, or directly positioned against the forefoot pedal. Optionally, the forefoot spring520can be positioned in any position that urges the forefoot sensor500open when the forefoot spring is in the first, expanded position.

In one aspect, the forefoot sensor500can be positioned on the sole130of the foot mold120such that when the forefoot sensor is open, the first end530of the forefoot pedal510can be coupled to the foot mold, and the second end540of the forefoot pedal can be spaced from the sole of the foot mold a predetermined distance. That is, in this aspect, the forefoot sensor can open towards the distal end160of the orthosis, as illustrated inFIG. 3. Optionally, in another aspect, the forefoot sensor500can be positioned on the sole130of the foot mold120such that when the forefoot sensor is open, the second end540of the forefoot pedal510can be coupled to the foot mold, and the first end530of the forefoot pedal can be spaced from the sole of the foot mold a predetermined distance. That is, in this aspect, the forefoot sensor can open towards the proximal end140of the orthosis instead of towards the distal end160, as illustrated inFIG. 3. It is also contemplated that the forefoot sensor500can be any type of sensor or switch capable of sensing changes in the position of the forefoot of the user.

In one aspect, at least a portion of the stop200can be sized and shaped to be positionable in the gap190defined between the foot mold120and the shank mold180. In another aspect, a shoulder portion210of the stop can be configured to engage the foot mold120and/or the shank mold180outside of the gap between the foot mold and the shank mold. In still another aspect, the stop can be positioned near the rear or posterior side of the ankle of the user when the orthosis100is being worn. That is, the stop200can be positioned near or adjacent to at least one of the proximal side of the foot mold120and the proximal side of the shank mold180as shown inFIGS. 1 and 3. Alternatively, however, the stop200can be positioned at any location that limits motion between the foot mold120and the shank mold180. The stop200can be sized and shaped to substantially or partially fill the gap190between the foot mold and the shank mold such that, by filling the gap, motion of the foot mold120relative to the shank mold180can be limited.

As described generally above, and more fully below, the stop200can be selectively movable from a closed position, in which at least a portion of the stop is positioned therein the gap190defined between the foot mold120and the shank mold180(as shown inFIGS. 3, 4, and8), to an open position, in which the stop is retracted from the gap between the foot mold120and the shank mold180(as shown inFIGS. 5-7). As can be appreciated, when the stop200is retracted from the gap190(i.e., in the open position), the foot mold120can move relative to the shank mold180. Further, when at least a portion of the stop is positioned in the gap between the foot mold and the shank mold (i.e., in the closed position), the foot mold120can be restricted from moving relative to the shank mold180. In another aspect, the stop can be retractable by moving rearward, in a posterior direction, in order to open the space between foot mold120and the shank mold180. In other aspects, the stop can be retractable up (toward the shank mold) or down (toward the foot mold), in order to clear the space between the foot mold120and the shank mold180. For example, the stop200can be retractable in a manner that is similar to the barrel of a spring-mounted pen, such that the stop is retracted downward towards relative to the foot mold and out of the gap between the foot mold120and the shank mold180.

In one aspect and as shown inFIG. 3, the connecting mechanism300comprises a plurality of linkages in order to mechanically control the position of the stop200in response to various positions of the heel sensor400and/or the forefoot sensor500, without requiring the use of motors or powered actuators. At least one linkage of the plurality of linkages of the connecting mechanism300can be mounted to a side wall of the foot mold120or, in particular aspects, can be more integrated into the side wall of the foot mold120or otherwise protected from inadvertent damage and the elements.

The connecting mechanism300, in one aspect, comprises at least one of a gear310, a gear latch320, a rotor330, and an energy transferring linkage350. In another aspect, the gear310can be connected by a fixed or rigid first linkage340to the heel sensor400, and by a fixed or rigid second linkage360to the stop200. The gear310can also be controlled in part by a gear latch320. In operation, as described more fully below, the gear310can move the stop200in response to motion of at least the heel sensor400. In one aspect, the first linkage340can be coupled eccentrically to the gear310so that motion of the lower linkage imparts rotation to the gear310. Similarly, in another aspect, the second linkage360can be coupled eccentrically to the gear310so that rotation of the gear310imparts movement to the second linkage.

Still with reference toFIG. 3, in one aspect, the gear310can comprise at least two teeth370a,370b. When the gear latch320is in contact with the first gear tooth370a(as illustrated inFIG. 3), the heel sensor400can be open (i.e., the second end440of the heel sensor can be spaced from the sole130of the foot mold120) and the stop200can be closed (i.e., positioned in the gap190between the foot mold and the shank mold180). When the heel sensor400is closed, the first linkage340rotates the gear310(clockwise inFIG. 3), and the rotating gear in turn moves the second linkage360, which thereby moves the stop200to the open position (i.e., moved or retracted out of the gap between the foot mold and the shank mold.) In another aspect, the gear310can further comprise a gear spring configured to bias the gear. For example, the gear spring can be configured to bias the gear310in a counterclockwise direction, as shown inFIG. 3, such that the stop is engaged or in the closed position. Optionally, the gear spring can be configured to bias the gear in a clockwise direction.

In one aspect, the gear latch320can comprise a first member322configured to couple to or otherwise engage a portion of the gear310, and a second member324configured to couple to or otherwise engage a portion of the energy transferring linkage350. In one aspect, the gear latch320can further comprise a torsional spring or other biasing member such that the gear latch320is biased toward the gear teeth (i.e., clockwise inFIG. 3).

In one aspect, the energy transferring linkage350can be positioned at an intermediate location such that the energy transferring linkage transfers mechanical energy from the rotor330to the gear latch320, as described below. In another aspect, the energy transferring linkage350can comprise a proximal arm352configured to couple to or otherwise engage a portion of the gear latch, and a distal arm354configured to couple to or otherwise engage a portion of the rotor. In use, energy imparted to the distal arm of the energy transferring linkage350from the rotor330can cause the energy transferring linkage to rotate and/or slide axially so that the proximal arm352of the energy transferring linkage350imparts this energy to the gear latch.

The rotor330can be a rotatable member coupled to both the forefoot sensor500and the gear310through the energy transferring linkage350. In one aspect, the rotor can comprise a first arm332configured to couple to or otherwise engage a portion of the energy transferring linkage350, and a second arm334configured to couple to or otherwise engage a portion of the forefoot sensor. In another aspect, mechanical energy from the forefoot sensor can be transferred through the rotor330to the energy transferring linkage. The rotor can optionally be positioned near or adjacent to the forefoot sensor500. In another aspect, the rotor can be connected by a fixed or rigid third linkage380to the forefoot sensor. The forefoot sensor500, as described above, can comprise the forefoot pedal510that is spring-biased toward the open position. In this aspect, the bias of the forefoot sensor500, via the third linkage, can spring-bias the rotor330downward near its second arm334(i.e., counterclockwise inFIG. 3). In another aspect, the rotor can comprise one or more optional torsional springs or other biasing members to provide additional bias and stability to the rotor.

When the forefoot sensor500is open, as shown inFIG. 3, the rotor330can be in a neutral position and the first arm332of the rotor can be resting against a portion of the distal arm354of the energy transferring linkage350. When the forefoot sensor500is closed, the third linkage380can rotate the rotor330(clockwise inFIG. 3), and the rotor330in turn allows the energy transferring linkage350to rotate (counter-clockwise inFIG. 3). When the energy transferring linkage350rotates, it can transfer the mechanical energy from the rotor330to the gear latch320, and move the gear latch such that the gear310moves from the second gear tooth370bback to the first gear tooth370a. This transfer to the first gear tooth, in turn, transfers a pulling force along the second linkage360and closes the stop200(i.e., moves the stop into the gap190between the foot mold120and the shank mold180).

FIGS. 4 through 8illustrate schematically the operation of the orthosis100described above. A smaller version ofFIG. 3is included asFIG. 3-1along withFIGS. 4-8for quick reference. InFIG. 4, the foot mold120is making initial contact with the floor or walking surface. At initial contact, the heel sensor400and the forefoot sensor500are open and the stop200is closed.

At or about the moment of heel strike, illustrated inFIG. 5, the heel sensor400moves to the closed position, thereby turning the gear310and opening the stop200. Heel strike is a first event in the stance phase30(illustrated inFIG. 2) and marks the opening of the stop, thereby facilitating plantar flexion during the stance phase. As the gear310rotates and moves the stop200out of the gap190between the foot mold120and the shank mold180, the first member322of the gear latch320becomes disengaged from its original position against the first gear tooth370aof the gear310. At a predetermined angular displacement of the gear latch relative to the longitudinal axis LFof the foot mold120, the first member of the gear latch320can settle into or engage the second gear tooth370bof the gear310. The engagement of the second gear tooth370band the gear latch can keep the gear310in the desired position so that the second linkage360maintains the stop200in the open position. In one aspect, the predetermined angular displacement can be less than about 5 degrees, about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, or greater than about 25 degrees.

FIG. 6illustrates mid-stance, when the forefoot touches the walking surface, according to one aspect. In mid-stance, the heel sensor400remains closed, the forefoot sensor500closes and the stop200is open. Note that that the shank mold180is rotated slightly clockwise relative to the foot mold120, indicating that the foot is in active plantar flexion at this point. That is, with the stop200in the open position, the angle formed between the longitudinal axis LFof the foot mold and the longitudinal axis LSof the shank mold can be changed as desired by a user of the orthosis100, and inFIG. 6, the user has rotated the foot downward relative to the ankle. When the forefoot of the user touches the walking surface, the forefoot sensor500closes and rotates the rotor330, which also allows the energy transferring linkage350to move. Notice that this rotation of the rotor330does not cause any reaction or change in position of the stop200. Instead, because the rotor330can be spring-biased, rotation of the rotor creates a store of mechanical energy in the forefoot spring520and/or the rotor spring. Notice also that the rotation of the energy transferring linkage350does not cause any reaction or change in the position of the stop200. The energy transferring linkage350can likewise be spring-biased, which means its rotation can also create an additional store of mechanical energy. Because the entire foot of the user engages the walking surface, the orthosis100can provide improved stability to the user during this phase of the gait cycle when compared to conventional orthotic devices.

At heel-off, illustrated inFIG. 7, the forefoot sensor500remains closed but the heel sensor400opens. When the heel sensor opens, the first linkage340exerts a force on a portion of the gear310causing the gear to rotate. The gear310, however, is selectively locked into position by the gear latch320. Unless and until the gear latch is moved, the gear310will not rotate.

At toe-off, illustrated inFIG. 8, the heel sensor400remains open and the forefoot sensor500opens. The opening of the forefoot sensor500releases the stored energy of the gear310, the rotor330, and/or the energy transferring linkage350. This stored mechanical energy in the rotor330, in the energy transferring linkage350, and/or in the gear310is released substantially simultaneously. For example, the energy of the rotor330can trigger movement in the energy transferring linkage350which, in turn, strikes the second member324of the gear latch320and pushes the first member322of the gear latch out of the second gear tooth370bof the gear310, thereby releasing the gear. When the gear310is released, the gear rotates back (counterclockwise inFIG. 3) until the first member322of the gear latch engages a portion of the first gear tooth370a. The movement of the gear310until the first member322of the gear latch320engages a portion of the first gear tooth370acauses the stop200to move back into the closed position, in which at least a portion of the stop is positioned in the gap190between the foot mold120and the shank mold180. In this aspect, the opening of the forefoot sensor500, through the linkages in the connecting mechanism300, causes the stop200to recoil back into its closed position.

After the position illustrated inFIG. 8, the stop200remains closed while the foot travels forward, through the swing phase40(illustrated inFIG. 2), until the foot once again makes initial contact with the walking surface (as shown inFIG. 4) and the process is repeated.

In use, in one aspect, the orthosis100can be worn as a shoe and the like. For example, a user could put his foot in the orthosis and use the orthosis in place of a shoe. Optionally, in another aspect, elements of the orthosis100could be added to a shoe. For example, at least one of the foot mold180, the stop200, the connecting mechanism300, the heel sensor400and the forefoot sensor500could be added to the shoe of a user so that, when the shoe is worn along with a shank mold180, the user of the device is selectively prevented from rotating his foot relative to his leg. In still another aspect, the orthosis100could be worn inside of a shoe. For example, the orthosis could be placed on the foot of a user, and the orthosis and foot could be inserted together inside of a shoe. In another aspect, elements of the orthosis could be formed integrally with a shoe. That is, at least one of the foot mold180, the stop200, the connecting mechanism300, the heel sensor400and the forefoot sensor500could be formed integrally with a shoe, and the remaining elements of the orthosis could worn on the foot and/or leg of a user.

Although the assemblies and methods are described herein in the context of an articulated ankle-foot orthosis, the technology disclosed herein is also useful and applicable in other contexts. Moreover, although several embodiments have been described herein, those of ordinary skill in art, with the benefit of the teachings of this disclosure, will understand and comprehend many other embodiments and modifications for this technology. The invention therefore is not limited to the specific embodiments disclosed or discussed herein, and that can other embodiments and modifications are intended to be included within the scope of the appended claims. Moreover, although specific terms are occasionally used herein, as well as in the claims or concepts that follow, such terms are used in a generic and descriptive sense only, and should not be construed as limiting the described invention or the claims that follow.