Patent Publication Number: US-9895246-B2

Title: Reactive intragastric implant devices

Description:
RELATED APPLICATIONS 
     This application is a divisional of U.S. Ser. No. 13/276,182, filed Oct. 18, 2011, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 61/394,708, filed Oct. 19, 2010, to U.S. Provisional Application No. 61/394,592, filed Oct. 19, 2010, and to U.S. Provisional Application No. 61/394,145, filed Oct. 18, 2010, the disclosures of which are incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to medical implants and uses thereof for treating obesity and/or obesity-related diseases and, more specifically, to transorally-delivered devices designed to occupy space within a stomach and/or stimulate the stomach wall and react to changing conditions within the stomach. 
     BACKGROUND OF THE INVENTION 
     Over the last 50 years, obesity has been increasing at an alarming rate and is now recognized by leading government health authorities, such as the Centers for Disease Control (CDC) and National Institutes of Health (NIH), as a disease. In the United States alone, obesity affects more than 60 million individuals and is considered the second leading cause of preventable death. Worldwide, approximately 1.6 billion adults are overweight, and it is estimated that obesity affects at least 400 million adults. 
     Obesity is caused by a wide range of factors including genetics, metabolic disorders, physical and psychological issues, lifestyle, and poor nutrition. Millions of obese and overweight individuals first turn to diet, fitness and medication to lose weight; however, these efforts alone are often not enough to keep weight at a level that is optimal for good health. Surgery is another increasingly viable alternative for those with a Body Mass Index (BMI) of greater than 40. In fact, the number of bariatric surgeries in the United States was estimated to be about 400,000 in 2010. 
     Examples of surgical methods and devices used to treat obesity include the LAP-BAND® (Allergan Medical of Irvine, Calif.) gastric band and the LAP-BAND AP® (Allergan). However, surgery might not be an option for every obese individual; for certain patients, non-surgical therapies or minimal-surgery options are more effective or appropriate. 
     In the early 1980s, physicians began to experiment with the placement of intragastric balloons to reduce the size of the stomach reservoir, and consequently its capacity for food. Once deployed in the stomach, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger. These devices are designed to provide therapy for moderately obese individuals who need to shed pounds in preparation for surgery, or as part of a dietary or behavioral modification program. These balloons are typically cylindrical or pear-shaped, generally range in size from 200-500 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, an inert gas, water, or saline. 
     One such inflatable intragastric balloon is described in U.S. Pat. No. 5,084,061 and is commercially available as the BioEnterics Intragastric Balloon System (“BIB System,” sold under the trademark ORBERA). The BIB System comprises a silicone elastomer intragastric balloon that is inserted into the stomach and filled with fluid. Conventionally, the balloons are placed in the stomach in an empty or deflated state and thereafter filled (fully or partially) with a suitable fluid. The balloon occupies space in the stomach, thereby leaving less room available for food and creating a feeling of satiety for the patient. Placement of the intragastric balloon is non-surgical, trans-oral, usually requiring no more than 20-30 minutes. The procedure is performed gastroscopically in an outpatient setting, typically using local anesthesia and sedation. Placement of such balloons is temporary, and such balloons are typically removed after about six months. Removing the balloon requires deflation by puncturing with a gastroscopic instrument, and either aspirating the contents of the balloon and removing it, or allowing the fluid to pass into the patient&#39;s stomach. Clinical results with these devices show that for many obese patients, the intragastric balloons significantly help to control appetite and accomplish weight loss. 
     Some attempted solutions for weight loss by placing devices in the stomach result in unintended consequences. For instance, some devices tend to cause food and liquid to back up in the stomach, leading to symptoms of gastroesophageal reflux disease (GERD), a condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus. Also, the stomach acclimates to some gastric implant devices, leading to an expansion of stomach volume and consequent reduction in the efficacy of the device. 
     Therefore, despite many advances in the design of intragastric obesity treatment implants, there remains a need for improved devices that can be implanted for longer periods than before or otherwise address certain drawbacks of intragastric balloons and other such implants. 
     SUMMARY OF THE INVENTION 
     Transoral three-dimensionally orthogonal intragastric spring devices generally promote a feeling of satiety in the patient by contacting the insides of the stomach wall. In addition, transoral three-dimensionally orthogonal intragastric spring devices generally allow for easy and quick placement and removal. Surgery is usually not required or very minimal. In one embodiment, the transoral three-dimensionally orthogonal intragastric spring devices may be placed in the patient&#39;s stomach through the mouth, passing the esophagus and reaching the destination. The transoral three-dimensionally orthogonal intragastric spring devices do not require suturing or stapling to the esophageal or stomach wall, and remains inside the patient&#39;s body for a lengthy period of time (e.g., months or years) before removal. 
     Each of the disclosed devices is formed of materials that will resist degradation over a period of at least six months within the stomach. The implantable devices are configured to be compressed into a substantially linear transoral delivery configuration and placed in a patient&#39;s stomach transorally without surgery to treat and prevent obesity by applying a pressure to the patient&#39;s stomach. 
     In one embodiment, a transoral three-dimensionally orthogonal intragastric spring device may fight obesity or reduce weight by stimulating the stomach walls of the patient. The three-dimensionally orthogonal intragastric spring device may be a purely mechanical device comprising a flexible body which in response to an input force in one direction, may deform and cause a resultant displacement in an orthogonal direction, thereby exerting a pressure on the inner stomach walls of the patient. 
     In another embodiment, a transoral three-dimensionally orthogonal intragastric spring device may include a variable size balloon. The balloon may be configured to occupy volume in the patient&#39;s stomach, thereby reducing the amount of space in the patient&#39;s stomach. 
     In a particular embodiment disclosed herein, a reactive implantable device comprises a three-dimensional spring structure comprising a plurality of legs each having opposite ends extended between top and bottom junctions of the spring structure defining an axis. Each leg has a flexible portion and a rigid portion attached to the flexible portion, wherein the flexible portions of each leg has a relaxed shape which causes the leg to bow laterally outward from the other legs thus maintaining the top and bottom junctions at a first distance apart. The implantable device is configured to react to inward forces from the stomach such that the flexible portions flex to straighten each leg and cause the axial spacing between the top and bottom junctions to increase from the first distance. The implantable device may have four or more legs, and the rigid portion comprises four or more distinct rigid members per leg. Each of the top and bottom junctions preferably comprises a quadrilateral-shaped cap, wherein the opposite ends of each leg are attached to different edges of the respective quadrilateral-shaped caps. 
     In one embodiment, a balloon is integrated with the three-dimensional spring structure and filled with fluid. The balloon may be within or outside the legs of the three-dimensional spring structure. If outside, the device may further include a pump located within the balloon and integrated with the three-dimensional spring structure configured to inflate and deflate the elastic balloon by transferring stomach liquid into and out of the elastic balloon. 
     Another reactive implantable device disclosed herein comprises a central elongated body having an adjustable length. Two collapsible atraumatic feet on opposite ends of the elongated body are configured to exert pressure on the patient&#39;s stomach when in a deployed position. A spring within the central elongated body biases the length of the body away from a minimum length. The two collapsible atraumatic feet may comprise balloon-like structures. The two collapsible atraumatic feet may alternatively comprise an array of living hinges that may be unfolded to an elongated delivery configuration and folded outward to a deployed configuration. In one embodiment, the array of living hinges is in an X-shape. The central elongated body preferably comprises a series of telescoping tubular members having apertures along their lengths. 
     A still further reactive implantable device includes an inflatable body having an internal volumetric capacity of between 400-700 ml and being made of a material that permits it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach. The body has a plurality of popout features on its surface that reside generally flush with the inflatable body in relaxed, retracted states, and which respond to an increase in pressure within the inflatable body by projecting outward from the body in a stressed, deployed state. The inflatable body may have a generally barrel shape along an axis. The popout features may be generally cylindrical, or are rounded bars oriented parallel to the axis. The popout features preferably convert between their retracted and deployed states by movement of rolling diaphragms formed in the inflatable body. 
     A still further reactive implantable device disclosed herein has an inflatable body with an internal volumetric capacity of between 400-700 ml and being made of a material that permits it to be compressed into a substantially linear transoral delivery configuration and that will resist degradation over a period of at least six months within the stomach. The body has a central inflatable member and at least two outer wings, and a single internal fluid chamber such that fluid may flow between the central inflatable member and the outer wings. The inflatable body is underfilled with fluid such that the outer wings are floppy in the absence of compressive stress on the central inflatable member and stiff when compressive stress from the stomach acts on the central inflatable member. The central inflatable member may have a generally spherical shape along an axis. There are preferably two outer wings extending in opposite directions from the generally spherical inflatable member along the axis. In one form, each of the outer wings includes a narrow shaft portion connected to the central inflatable member terminating in bulbous heads. 
     The invention also comprises a reactive implantable device configured for transoral placement into a patient&#39;s stomach for the treatment of obesity by applying a pressure to the patient&#39;s stomach, the implantable device comprising: a spring or spring type structure having a plurality of legs each leg having opposite ends extended between top and bottom junctions of the spring thereby defining an axis, each leg also having a flexible portion and a rigid portion attached to the flexible portion, wherein the flexible portions of each leg has a relaxed shape which causes the leg to bow laterally outward from the other legs to thereby maintain the top and bottom junctions at a first distance apart, and wherein the implantable device is configured to react to inward forces from the stomach such that the flexible portions flex to straighten each leg and cause the axial spacing between the top and bottom junctions to increase from the first distance, wherein the device is formed of materials that permit it to be compressed into a substantially linear transoral delivery configuration and that will resist substantially resist degradation over a period of at least six months within the stomach. To substantially resist degradation means that when placed in the acid environment of the stomach the device still functions at least substantially as intended, that is a clinically significant result (i.e. weight loss or the maintenance of a weight loss) can still be obtained. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following detailed descriptions are given by way of example, but not intended to limit the scope of the disclosure solely to the specific embodiments described herein, may best be understood in conjunction with the accompanying drawings in which: 
         FIG. 1  illustrates a perspective view of a reactive intragastric implant comprising a three-dimensionally orthogonal intragastric spring device in accordance with one or more embodiments described herein; 
         FIG. 2A  illustrates a rigid member of a three-dimensionally orthogonal intragastric spring device as in  FIG. 1 ; 
         FIG. 2B  illustrates a rigid member molded to the three-dimensionally orthogonal intragastric spring device of  FIG. 1 ; 
         FIG. 2C  illustrates an uncapped three-dimensionally orthogonal intragastric spring device of  FIG. 1 ; 
         FIG. 2D  illustrates a three-dimensionally orthogonal intragastric spring device as in  FIG. 1  in a deformed geometry; 
         FIG. 3  illustrates a flow diagram describing the steps of manufacture of a three-dimensionally orthogonal intragastric spring device in accordance with one or more embodiments described herein; 
         FIG. 4A  illustrates a three-dimensionally orthogonal intragastric spring device as in  FIG. 1  with input forces in a first direction and the resultant displacement; 
         FIG. 4B  illustrates a three-dimensionally orthogonal intragastric spring device as in  FIG. 1  with input forces in a second direction and the resultant displacement; 
         FIG. 4C  illustrates a three-dimensionally orthogonal intragastric spring device as in  FIG. 1  with input forces in a third direction and the resultant displacement; 
         FIG. 5A  illustrates a three-dimensionally orthogonal intragastric spring device with an external intragastric balloon in accordance with one or more embodiments described herein; 
         FIG. 5B  illustrates a three-dimensionally orthogonal intragastric spring device with an internal intragastric balloon in accordance with one or more embodiments described herein; 
         FIG. 6  illustrates a perspective view of another embodiment of the three-dimensionally orthogonal intragastric spring device as in  FIG. 1  with a variable size external balloon inflated; 
         FIG. 7  illustrates a perspective view of an alternative reactive intragastric implant inside a patient&#39;s stomach having an elongated spring-biased shaft with soft, folded feet; 
         FIG. 8  illustrates a perspective view of the reactive intragastric implant of  FIG. 7  showing exemplary spring-biasing structure therein; 
         FIGS. 9A-9C  are perspective and sectional views of an alternative reactive intragastric implant comprising a generally barrel-shaped inflatable member having “pop-out” surface features in refracted positions, while  FIGS. 10A-10C  are equivalent views with the pop-out surface features in extended positions; 
         FIGS. 11A-11C  are sectional views through one of the pop-out surface features illustrating a preferred rolling diaphragm wall structure enabling movement from the retracted to the extended position; 
         FIGS. 12A-12C  are perspective and sectional views of a further barrel-shaped inflatable intragastric implant having elongated “pop-out” surface features in retracted positions, while  FIGS. 13A-13C  show the elongated pop-out surface features in extended positions; 
         FIG. 14  illustrates another a reactive intragastric implant comprising an underfilled inflatable member having outer wings that transition between floppy to stiff configurations; 
         FIGS. 15A-15B  show the intragastric implant of  FIG. 14  implanted in the stomach in both relaxed and squeezed states, showing the transition of the outer wings between floppy and stiff configurations; 
         FIGS. 16 and 17  illustrate intragastric devices that encourage rotational variation; and 
         FIGS. 18 and 19  illustrate intragastric devices that both encourage rotational variation and provide additional stomach cavity stimulation. 
     
    
    
     DESCRIPTION OF THE DETAILED EMBODIMENTS 
     Persons skilled in the art will readily appreciate that various aspects of the disclosure may be realized by any number of methods and devices configured to perform the intended functions. Stated differently, other methods and devices may be incorporated herein to perform the intended functions. It should also be noted that the drawing FIGS. referred to herein are not all drawn to scale, but may be exaggerated to illustrate various aspects of the invention, and in that regard, the drawing FIGS. should not be construed as limiting. Finally, although the present disclosure may be described in connection with various medical principles and beliefs, the present disclosure should not be bound by theory. 
     By way of example, the present disclosure will reference certain transoral three-dimensionally orthogonal intragastric spring device. Nevertheless, persons skilled in the art will readily appreciate that the present disclosure advantageously may be applied to one of the numerous varieties of three-dimensionally orthogonal intragastric spring devices. 
     In one embodiment, these three-dimensionally orthogonal intragastric spring device described herein are intended to be placed inside the patient, transorally and without invasive surgery, without associated patient risks of invasive surgery and without substantial patient discomfort. Recovery time may be minimal as no extensive tissue healing is required. The life span of these transoral three-dimensionally orthogonal intragastric spring devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. 
       FIG. 1  illustrates one embodiment of a transoral three-dimensionally orthogonal intragastric spring device, namely spring device  100 . The spring device  100  features a plurality of legs  125  having opposite ends extending between upper and lower junctions  115 ,  120 . The legs  125  each include rigid portions  105  integrated with flexible or elastic portions  110 . The elastic portions  110  extend the entire length of the legs  125  and essentially form the legs, with the rigid portions  105  being embedded or otherwise intimately attached thereto. In the illustrated embodiment, the spring device  100  has two rigid portions  105  for every leg  125 . More particularly, one rigid portion  105  may be embedded within the flexible portions  110  in the top half of the leg  125 , and a second rigid portion  105  may be embedded within the flexible portions  110  of the second half of the leg  125 . In one embodiment, the rigid portions  105  have substantially the same thickness as the flexible portion  110 , and extend a short distance along each leg. As there are four legs  125  shown, a total of eight rigid portions  105  may be included in this embodiment of the spring device  100 . The elastic portion  110  of each leg  125  primarily controls the bending flexibility of the leg, while the rigid portions  105  contribute rigidity to certain areas. In the illustrated configuration, therefore, the flexible portions  110  are relatively unconstrained at their top and bottom ends, and in a middle section between the upper and lower rigid portions  105 . 
     The legs  125  are attached and held together by the top and bottom junctions  115  and  120 , respectively. The junctions  115 ,  120  desirably comprise top and bottom caps. As shown, the caps forming the junctions  115  and  120  are quadrilateral in configuration and each leg  125  attaches to a different one of the four sides of the caps  115  and  120 . As shown, the spring device  100  is in a natural state and fully functional. That is, the shape shown in  FIG. 1  is the relaxed shape of the device  100 , with the elastic portions  110  of each leg  125  in equilibrium and not under any bending stress. 
     In one embodiment, the materials used to construct the spring device  100  may include metals, thermoplastics, thermoplastic elastomers, silicones, glass, thermosets or any combination thereof. More particularly, the rigid portions  105  may be made of a more rigid material such as a silver alloy or glass, while the flexible portions  110  may be constructed out of elastomeric materials. If silver is used, the rigid portions  105  provide an antiseptic benefit to the device  100  to prevent bacteria from growing. The junction caps  115  and  120  may also be constructed out of rigid materials. In one embodiment, the flexible portions  110  may be constructed out of one material, while the rigid portions  120  and the junction caps,  115  and  120 , are constructed out of a second material. 
     In the embodiment illustrated in  FIGS. 2A-2D , each rigid portion  105  comprises a pair of rigid strips  205  embedded within or otherwise secured along the corresponding flexible portion  210 . A single rigid portion  205  is shown in  FIG. 2A . Each rigid portion  205  appears as parallel, unattached strips that attach in parallel pairs along opposite circumferential sides of the host flexible portion  210 . Preferably, the rigid portions  205  are substantially unbendable and inflexible, though such terms are relative. Alternatively, the rigid portions  205  may still have elastic qualities, but might not be as elastic or flexible as the rest of the spring device  200 , and in particular, the flexible portions  210 . For instance, if the flexible portions  210  are formed of an elastomer, such as silicone, then the rigid portions  205  could be silver or glass, both of which are relatively less flexible, though silver bends under the influence of greater forces and glass will eventually crack due to its brittle nature. However, if glass is used the small size of each rigid portion  205  and relatively low bending stresses imparted thereto ensures a high degree of confidence that the glass will not break. Ceramic is another option. 
       FIG. 2B  shows the rigid portion  205  attached or molded to the flexible portion  210 , thus forming a leg  225 . As shown, the leg  225  may flex at any of the purely flexible portions  210 , but are less flexible along the rigid portions  205 . In one embodiment, between the parallel rigid portions  205  is a portion of the flexible portion  210 . In other words, the flexible portion  210  of the leg may constructed as one piece, whereas the rigid portions  205  may be constructed separately and molded to the flexible portion  210 .  FIG. 2C  illustrates four legs  225  arranged uniformly with top and bottom caps. When the caps are attached, the spring device  200  is complete, and may appear similar to the spring device  100 . 
       FIG. 2D  illustrates the spring device  200  with caps (e.g., top and bottom junction caps  215  and  220 ) holding the legs  225  attached in place. Here,  FIG. 2D  illustrates the spring device  200  in a deformed, stressed, or straightened state. As shown, the flexible portions  210  are no longer in a curved configuration (e.g., in a natural, relaxed state), but instead is shown in a relatively straightened position. The rigid portions  205  are still substantially flat, similar to the rigid portions as shown in  FIGS. 2A-2C . Overall, the spring device  200 , is flat and elongated (e.g., the distance between junction caps  215  and  220  is extended when compared to the distance between junction caps  215  and  220  in the configuration of  FIG. 2C ). Accordingly, this position is advantageous for inserting the spring device  200  through a patient&#39;s mouth, down the esophagus and into the patient&#39;s stomach, and can be maintained within a delivery tube, for example. 
     Next, a method of manufacturing of a spring device (e.g., spring device  100  or  200 ) will be discussed. While the following description refers to spring device  100  specifically, the same principles apply to spring device  200  or any other embodiment of the spring device equally. 
       FIG. 3  illustrates a method of manufacturing a spring device  100 . At step  305 , the rigid portions or members  105  may be initially formed. At step  310 , elastic material is overmolded on the rigid members  105 . The elastic material may comprise the flexible portions  110 , and the resulting component of the rigid members  105  with the elastic material may be considered a leg  125 . After a plurality of legs are constructed (e.g., four legs as shown in  FIG. 1 , but any number of legs of 2 or more may be constructed—such as 3 legs, 5 legs, 6 legs, etc.), the legs  125  may be oriented to be evenly spaced apart at step  315 . At step  320 , the legs  125  may be coupled by a top cap  115  and a bottom cap  120 . The ends of the legs  125  may be glued into the caps  115 ,  120 , heat bonded, secured with fasteners, etc. In one embodiment, the caps  115 ,  120  are crimped onto the ends of the legs  125 . In one aspect, the top and bottom junction caps  115  and  120  have a number of edges equal to the number of legs. For example, as shown in  FIG. 1 , the top and bottom junction caps,  115  and  120 , have 4 edges each, one for each of the legs  125 . 
     After formation, and well before or just prior to use, the spring device  100  may be placed inside a removable sleeve, band, or otherwise held in a “deformed” or straightened position (e.g., as shown in  FIG. 2D ), at step  325 , and in this position, the spring device  100  may be ready for insertion into the patient&#39;s stomach. In one embodiment, the sleeve or band holding the spring device  100  in a straightened position may be configured to be removable by a standard grabber. For example, the band may have a “snap-on” buckle that is releasable by using a standard grabber to press on a certain portion of the buckle. Alternatively, the sleeve or band may be constructed out of a non-toxic, digestible substance, such as a food or other commonly edible substance like a sugar, so that the sleeve or band may be “removed” by the natural acids inside the patient&#39;s stomach after insertion by the patient&#39;s natural digestion process. As a result of the digestion of the sleeve or band, the spring device  100  may revert back to an unfolded, compressed configuration (e.g., as shown in  FIG. 1 ). In other words, the sleeve or band acts to decompress and elongate the spring device (e.g., spring device  100  or  200 ), and the removal of the sleeve or band causes the spring device to contract. 
     For removal, a standard grabber may encircle the spring device  100  at the flexible portions  110  and decompress the spring device into a straightened state for easy removal. In one embodiment, the flexible portions  110  configured to be “grabbed” by the standard grabber to decompress the spring device  100  may be injected with a radio opaque additive during the construction of these portions so that the physician may identify and view these portions when viewing an x-ray during the removal procedure. 
     Turning to  FIGS. 4A-4C , the operation of the spring device  100  deployed inside the patient&#39;s stomach will be discussed. Initially, the spring device  100  may reside in the patient&#39;s stomach in the configuration as shown in  FIG. 1 . As the spring device  100  begins to migrate about the patient&#39;s stomach due to stomach contractions and/or the patient&#39;s position (e.g., the patient is sitting down, lying down, etc.), the spring device  100  may begin to variably rotate and may exert pressure on the patient&#39;s stomach in some positions, while not exerting pressure on the patient&#39;s stomach in other positions. 
       FIG. 4A  illustrates the spring device  100  where axial compression is exerted on the spring device  100  at the location of the junction caps  115  and  120  (as shown by arrows  400 ). The pressure exerted by the stomach walls as shown by arrows  400  causes the flexible portions  110  to flex outwards, away from one another, and as a result, the flexible portions  110  pressure the stomach walls in a direction shown by arrows  410 . 
     In another embodiment, as shown by  FIG. 4B , when lateral compression is exerted on the spring device  100  at the location of the flexible portions  110  (as shown by arrows  420 ) by the stomach walls contracting, other flexible portions  110  may also compress (as shown by arrows  430 ) and, as a result, the junction caps  115  and  120  of the spring device  100  move axially outwards in a direction shown by arrows  440  causing pressure on a different portion of the stomach walls. 
     Similarly, as shown by  FIG. 4C , when lateral compression is exerted on the spring device  100  at the location of the flexible portions  110  (as shown by arrows  450 ) by the stomach walls contracting, other flexible portions  110  may also compress (as shown by arrows  460 ) and, as a result, the junction caps  115  and  120  of the spring device  100  move axially outwards in a direction shown by arrows  470  causing pressure on a different portion of the stomach walls. 
     As described above with respect to  FIGS. 4A-4C , an input pressure exerted on the spring device  100  by the inner stomach wall may result in an output pressure exerted by the spring device  100  on the inner stomach wall at a location orthogonal to the location of the input pressure. Moreover, as the spring device  100  rotates and moves around variably within the patient&#39;s stomach, the spring device  100  may occupy different three-dimensional space areas within the patient&#39;s stomach and may also contact and exert a pressure on the patient&#39;s stomach in any of a number of different locations of the inner stomach wall. In this fashion, the spring device  100  limits the ability of the stomach to adapt over long term implantation. 
     In different embodiments, the spring device (e.g., spring device  100  or  200 ) may further include an intragastric balloon.  FIGS. 5A and 5B  illustrate two examples of such embodiments.  FIG. 5A  is an example of an embodiment with an external intragastric balloon  500  surrounding the spring device  100 . Alternatively, as shown in  FIG. 5B , an internal intragastric balloon  502  may be located inside the legs  125  of spring device  100 . Here, the intragastric balloon  502  may be held in place inside the spring device  100  by the particular configuration of the legs  125 . By utilizing an intragastric balloon (e.g.,  500  or  502 ), the spring device  100  may also act as an effective volume occupying device inside the patient&#39;s stomach, thereby reducing the amount of space inside the patient&#39;s stomach to hold food. The balloons are desirably saline-filled. 
       FIG. 6  illustrates another embodiment of a transoral device  504  comprising an external gastric balloon  500  in conjunction with the spring device  100 . Legs of the spring device  100  desirably attach and/or are integrated into a central tubular body  520  of the intragastric balloon  500 . For instance, the aforementioned end caps may be rigidly integrated into the tubular body  520 . As shown, the intragastric balloon  500  may comprise a “balloon” layer  505 ; that is the balloon  500  may not extend completely around but may be open at opposite poles for passage of the body  520 . 
     In one embodiment, the transoral device  504  may be considered a two-phase intragastric device. In the first phase, the intragastric balloon  500  expands to a sufficient volume that effectively negates the impact of the spring device  100 . That is, the intragastric balloon  500  may be so large that the legs of spring device  100  never contact the inside of the stomach walls. In this phase, the spring device  100  is a purely volume occupying device. In a second phase, the volume of the intragastric balloon  500  is reduced (deflated) such that the legs of the spring device  100  protrude against the “walls” or balloon layer  505  of the intragastric balloon  500 , thereby receiving input pressures from the stomach walls during contraction, and causing the spring device  100  to react as described above with respect to  FIGS. 4A-4C . In this second phase, the transoral device may be both a volume occupying device and an inner wall stimulating device. Since the volume of the intragastric balloon  500  may be controlled according to a schedule and/or externally by a physician, either the first or second phase may be selected in order to best assist the patient to lose weight based on the time of day or in relationship to the patient consuming food. For example, during meals, it may be more beneficial to stimulate the stomach walls and thus, phase two may be more appropriate, but between meals, it may be more beneficial just to have a larger volume occupied in the stomach and thus, phase one may be more appropriate. In one embodiment, the transoral device  504  may be configured to move from a first phase to a second phase, back to the first phase, etc. according to a schedule or other trigger. 
     The inflatable balloon device  504  may be inflated and filled with stomach juices naturally occurring and produced in the patient&#39;s body. At the outer surface of the top  510  of the central tubular body  520  is an opening  515  that functions as an intake for a peristaltic pump  525  integrated into the body  520 . The pump  525  pulls stomach juices into the inflatable layer  505  to fill and expand the balloon  500 , or pushes out stomach juices from inside the inflatable layer  505  to deflate the balloon  500 . Though not shown in great detail, the peristaltic pump  525  includes two openings, the inlet opening  515  at the top of the body  520  and an outlet opening (not shown) leading to the space within the inflatable layer  505 . Peristaltic rollers  535  of the pump  525  are in fluid connection with flexible tubes that connect to the inlet and outlet openings. In operation, the rollers  535  rotate in one direction to move stomach fluid from one tube to the other tube and out of outlet opening  515 , thereby deflating the inflatable balloon device  504 . Opposite rotation of the rollers  535  pulls stomach fluid in the inlet opening  515  and expels it to the cavity of the inflatable layer  505 , thus inflating the balloon device  504 . The inflatable balloon device  504  may further include a control portion or control board  530  and motor (not shown). By inflating the inflatable balloon device  504  to a volume between about 0 milliliters (mL) and about 1000 mL (but preferably between about 400 mL and about 700 mL), the balloon device  504  occupies space in the stomach decreasing the amount of space for food, and also stimulates the stomach walls when the inflatable balloon device  504  (via inflation and/or migration) exerts a pressure on the inner stomach walls. 
     The rollers  535  may be controlled according to any of a number of methods. Initially, when the inflatable balloon device  504  is first deployed in the patient&#39;s stomach, the control board  530  may read a schedule (stored in memory) providing instructions related to the different volumes that inflatable balloon device  504  may adjust to, and at which times. In one example, the schedule may be a daily schedule that the inflatable balloon device  504  follows. Alternatively, the schedule may be for a week, month, year and so forth. After the schedule is read, the target volume may be determined, and the motor may be driven to achieve the target volume. Subsequently, the inflatable balloon device  504  may determine if a trigger to change the volume is detected. For example, the trigger may be merely determining that the schedule dictates a changing of the volume of the inflatable balloon device  504 . Other triggers may include a command from an external computer to change the volume of the inflatable balloon device  504 . 
     A portion of the central body  520  of the inflatable balloon device  504  is desirably covered by an antiseptic band  560 . The band  560  may be a separate piece of metal attached to the body  520 , or may be directly integrated into the body  520  as an exterior layer. The band  560  may be constructed of any material with cleansing, antiseptic qualities. In one example, silver may be used to form the band since silver has natural antiseptic qualities. The function of the band  560  is to passively disinfect the stomach fluid inside the inflatable layer  505 . 
     The insertion process for the inflatable balloon device  504  may be as simple as having the patient swallow the device while in a deflated state. Alternatively, the inflatable balloon device  504  in a deflated state may be carefully inserted through the mouth of the patient, down the esophagus and into the patient&#39;s stomach by using a standard grabber. 
     The removal process for the inflatable balloon device  504  may be substantially the reverse of the insertion process. After substantially deflating the inflatable balloon device  504 , a standard grabber may be used to clamp onto one end of the device and pulled back up through the esophagus and out the patient&#39;s mouth. 
       FIG. 7  illustrates an alternative reactive intragastric implant  600  implanted inside a patient&#39;s stomach in a state exerting pressure on the patient&#39;s inner stomach walls. The implant  600  comprises an elongated spring-biased tubular shaft or body  605  with soft, folded atraumatic feet  620  on opposite ends. The tubular body  605  preferably comprises a telescoping structure such that one end  620  attaches to a shaft portion that moves relative to another shaft portion attached to the opposite end, the two shaft portions being spring-biased away from a minimum length. The intragastric implant  600  may reduce appetite as the feet  620  contact and pressure the inside of the patient&#39;s stomach walls, thereby affecting nerves and causing early feelings of satiety. 
     The intragastric implant  600  is configured to telescope to varying lengths. For example,  FIG. 8  illustrates the intragastric implant of  FIG. 7  in an extended position. As shown, extension portions  650  attached to opposite feet  620  are sized smaller than a throughbore of the tubular body  605  and are arranged to slide therein. A spring  645  couples to the extension portions  650  for each foot  620 . Inward pressure from the inner stomach walls causes the implant  600  to adjustably telescope to experience a reduction in length. When the extension portions  650  telescope out from within the tubular body  605 , the length of the intragastric implant  600  increases. The varying length intragastric implant  600  is desirably reactive in that the size change occurs in reaction to external stomach forces. In one embodiment, a minimum length for the intragastric implant  600  is between about 8-12 cm, while a maximum length is between about 12-15 cm. 
     Here, no electronics are required. The benefit to this embodiment is that no motor is required (and hence, the production of the implant  600  may be cheaper). However, the trade-off is that the patient&#39;s body may have a higher likelihood of compensating to a spring-biased implant  600  since the telescoping depends on the position of the implant and cannot change randomly or according to a diverse schedule. Nevertheless, the action of the reactive intragastric implant  600  is believed to be sufficiently variable to prevent accommodation by the stomach. 
     The feet  620  may be bent to a straightened or elongated position to allow easier implantation and removal. In embodiment, the entire intragastric implant including the feet  620  (in a straightened state, not shown) may be no larger than 10 millimeters (mm) in diameter, thereby easily passing transorally into the patient&#39;s mouth, through the esophagus and into the patient&#39;s stomach. However, once implanted inside the patient&#39;s stomach, the feet fold to the deployed state as shown in  FIGS. 7 and 8 . In this state, the feet point outwards and prevent migration through the pylorus, and then the intestines. In another aspect, removal of the reactive intragastric implant  600  may be easily performed using a standard grabber. Once the feet  620  are straightened and the implant  600  is axially compressed, the entire implant  600  may be easily pulled up through the patient&#39;s stomach and esophagus and exit the patient&#39;s mouth. 
     The feet  620  are configured to be atraumatic, in that they are soft and pliable. The feet  620  are desirably formed as an array of fingers of a soft polymer, each preferably having thinned regions so as to function like living hinges. More particularly, each of the spokes of the “X” shaped feet  620  has a rectangular cross-section to facilitate bending in one plane, and thinned regions at three points: where it connects to the respective extension portion  650 , where it connects to the other spokes along an axis of the device, and at a mid-portion which forms the outermost end of each of the spokes in the deployed configuration seen in  FIGS. 7 and 8 . When the intragastric implant  600  exerts pressure on the stomach walls the feet  620  bend or flex back toward the tubular body  605 . Advantageously, even in this pressuring state, the end portion  620  is not able to migrate through the pylorus. In other words, even at the pressuring state, the foot  620  is still too large to fit through the pylorus. Of course other configurations for the atraumatic feet are contemplated, such as rounded pillows, cups, or the like. Regardless of which embodiment of the reactive intragastric implant  600 , the feet  620  may be, for example, an acid-resistant plastic or any other appropriate material injected with radio-opaque additive so that they may be seen with an x-ray machine during the removal procedure. 
     Furthermore, the tubular body  605  and extension portions  650  are desirably hollow and include through holes  695  to allow stomach juices to flow through. The tubular body  605  and extension portions  650  may be constructed, for example, out of a polysulphone, polypropylene or an acid-resistant plastic material configured to resist the strong acidity of the stomach juices. 
       FIGS. 9A-9C  illustrates an alternative reactive intragastric implant  700  comprising a generally barrel-shaped inflatable member  702  having a multiplicity of “pop-out” surface features  704  on its surface that reside generally flush with the inflatable body in relaxed, retracted states, and which respond to an increase in pressure within the inflatable body by projecting outward from the body in a stressed, deployed state. The popout surface features  704  as illustrated are small circular dimples in the wall of the inflatable member provided in three rows spaced along an axis of the inflatable member  702 . In one embodiment, the surface features  704  in the middle row are offset from those in the top and bottom rows. Of course, other patterns and spacing of the surface features  704  are possible.  FIGS. 10A-10C  are equivalent views with the pop-out surface features  704  in extended positions, wherein they form outwardly projecting cylinders from the remainder of the substantially barrel-shaped inflatable member  702 . 
       FIGS. 11A-11C  are sectional views through one of the pop-out surface features  704  illustrating a preferred rolling diaphragm wall structure. That is, each surface features  704  in its retracted position of  FIG. 11A  includes a cylindrical portion  710  that connects to the surrounding flat wall portion  712  via a 360° rolling diaphragm  714 . As pressure within the inner chamber of the inflatable number  702  increases, the cylindrical portion  710  begins to project from the surrounding wall portion  712  as seen in  FIG. 11B . This occurs by virtue of the rolling diaphragm  714 , which gradually transitions to become a part of the side of the cylindrical portion  710 . Finally, in  FIG. 11C , the cylindrical portion  710  projects outward from the wall portion  712  a maximum distance, and the rolling diaphragm  714  is at its minimum length. Of course, a reduction in pressure within the inner chamber of the inflatable member  702  causes a reverse action, by virtue of the elasticity of the rolling diaphragm  714 . That is, the “as-molded” shape of each surface feature  704  is as shown in  FIG. 11A , such that the default position is that in which the cylindrical portion  710  is retracted to be approximately level with the surrounding wall portion  712 . 
       FIGS. 12A-12C  illustrates a further barrel-shaped inflatable intragastric implant  720  having elongated “pop-out” surface features  722  in retracted positions, while  FIGS. 13A-13C  show the elongated pop-out surface features in extended positions. In this configuration, there are a total of six elongated surface features  722  arranged equidistantly around the circumference of the implant  720 , and centrally positioned along its axis. The surface features  722  desirably function the same as described above, with rolling diaphragms permitting the bar shaped elements to ultimately project and retract relative to the surrounding wall portions. Indeed, the sectional views of  FIGS. 11A-11C  equally represent a horizontal section through one of the bar-shaped surface features  722 , at least away from its ends. 
     The intragastric implants  700 ,  720  described above are primarily volume occupying, similar to current gastric balloons. As such, the fill volume is desirably the same, preferably between 400-700 mL. However, because of the popout surface features, the implants also provide enhanced stimulation to the surrounding stomach walls, which induces satiety. Furthermore, a number of rotationally variant intragastric implants are shown below with reference to  FIGS. 16-17 , and the popout features could easily be incorporated therein to provide further stimulation to the stomach walls. 
     The two embodiments of intragastric implants  700 ,  720  with popout features  704 ,  722  shown in  FIGS. 9-13  are exemplary only, and numerous other configurations are contemplated. For example, the above features are shown as being evenly distributed over the surface of the implants, while in the alternative the features can be randomly distributed. Also, the polar ends of the barrel-shaped implant  700 ,  720  are shown absent of the popout features, though they can be provided all over the devices. Likewise, the shape of the projecting popout features  704 ,  722  are relatively rounded; domed cylindrical in the first embodiment and half tubular in the second. However, more angular or pointed shapes can be molded into the walls of intragastric implants and surrounded by rolling diaphragms so that the resulting projections are somewhat more stimulating to the inner walls of the stomach. 
     Finally, a “rolling diaphragm” refers to a region surrounding each of the popout features that permits a projection to remain retracted until an inner chamber of the implant is pressurized, at which time it extrudes out from the surrounding wall surfaces. The illustrated embodiment of rolling diaphragm shows a continuous transition of the diaphragm which “rolls” at a crease. Another way to define rolling diaphragm is a surface feature that allows for a change in the outer surface shape without any change in surface area. These intragastric implants experience bending stresses to change shape, rather than experiencing tensile stretching, which improve the durability of the devices. The same function can be obtained with structure that is more hinged as opposed to rolling, such that there is a sudden transition between a retracted position to a projecting position. Additionally, other popout configurations include a folded or spiral shape that unfolds when pressurized, elements that lie flat against the wall of the implant until pressurized, thinned regions of the wall which bow outward from surrounding figure wall portions, etc. It should be understood that the term “popout features” encompasses all of these variations. 
       FIG. 14  illustrates a still further reactive intragastric implant  740  comprising an underfilled central inflatable member  742  having outer wings  744  that transition between floppy to stiff configurations. The entire implant  740  defines a single fluid chamber therein. In the illustrated embodiment, the inflatable member  742  is substantially spherical, while the outer wings  744  resemble stems with a narrow proximal shaft  746  terminating in a bulbous head  748 . Also, a pair of the outer wings  744  extend from opposite poles of the spherical inflatable member  742 , which is believed to facilitate alignment of the implant  740  within the stomach, though more than two such wings distributed more evenly around the inflatable member could be provided. 
       FIG. 15A  shows the intragastric implant  740  implanted in the stomach in a relaxed state, while  FIG. 15B  shows the implant in a squeezed state, illustrating the transition of the outer wings  744  between floppy and stiff configurations. The shape of the central inflatable member  742  in  FIG. 15B  is a representation of the shape as if squeezed by the surrounding stomach walls, however the illustrated stomach is shown in its relaxed configuration. Transition between the relaxed and squeezed state of the implant  740  occurs when the stomach walls squeeze the central inflatable member  742 , thus pressurizing the outer wings  744 . In other words, fluid is driven from the central member  742  and into the outer wings  744 . In a certain sense, the outer wings  744  function similar to the popout features, though they are always external to the central inflatable member  742 . 
     Initially, the entire implant  740  is underfilled with a fluid such as saline or air to a degree that the wings  744  are floppy, and a predetermined compressive force causes them to become stiff. For example, the fully filled volume of the intragastric implant  740  may be between 400-700 mL, though the implant is filled with less than that, thus providing slack for flow into the wings  744 . Additionally, it should be noted that underfilling the implant  740  results in lower stresses within the shell wall, which may improve the degradation properties of the material within the stomach&#39;s harsh environment. 
       FIGS. 16 and 17  illustrates certain specific features that may encourage rotational variation. In  FIG. 16 , an intragastric obesity treatment device  890  essentially comprises an aggregation of spheres  892 . The overall exterior shape of the device is somewhat spherical, encouraging rotation. However, the outwardly projecting spheres that make up the device contact the stomach wall at different locations as the device rotates. In  FIG. 17 , a device  900  comprises a plurality of outwardly projecting legs  902  terminating in rounded or bulbous feet  904 . Again, the device  900  rotates relatively easily within the stomach, especially upon peristaltic motion, and the separated legs  902  and feet  904  therefore contact the stomach wall at different locations on a constantly changing basis. These features can be utilized in a device that looks like the device  900 , or can be added to the number of the embodiments described herein, such as the inflated balls of  FIGS. 8 and 10 . 
     The devices  890 ,  900  of  FIGS. 16 and 17  may also serve to temporarily block the pylorus and slow gastric emptying. Consequently, such protrusions as the spheres  892  and bulbous feet  904  may be added to a number of the devices described herein. 
     Another option for a number of the intragastric devices disclosed herein is to add exterior stimulation features, such as any raised or depressed geometry which act to stimulate certain portions of the stomach walls. Such features may be particularly effective for those embodiments which stimulate the cardia. For instance,  FIG. 18  illustrates a spherical intragastric device  910  having numerous external bumps  912  projecting outward therefrom. These bumps  912  separately contact the inner walls of the stomach, potentially increasing the stimulation to the surrounding satiety-sensing nerves. Another example of exterior stimulation features is seen in  FIG. 19 , where an intragastric device  920  formed as a sphere features a multitude of small flagella  922  extending outward therefrom. It should be noted that the two embodiments shown in  FIGS. 18 and 19  rotate freely within the stomach, and that the bumps  912  or flagella  922  may be provided in a non-uniform distribution so as to take advantage of the benefits of the rotational variation described above. That is, a regular array of such exterior features may stimulate the stomach wall more than a smooth surface, but also providing a non-uniform distribution will create different sensations on a constantly changing basis. 
     It should also be stated that any of the embodiments described herein may utilize materials that improve the efficacy of the implant. For example, a number of elastomeric materials may be used including, but not limited to, rubbers, fluorosilicones, fluoroelastomers, thermoplastic elastomers, or any combinations thereof. The materials are desirably selected so as to increase the durability of the implant and facilitate implantation of at least six months, and preferably more than 1 year. 
     Material selection may also improve the safety of the implant. Some of the materials suggested herein, for example, may allow for a thinner wall thickness and have a lower coefficient of friction than the implant. 
     The implantable devices described herein will be subjected to clinical testing in humans. The devices are intended to treat obesity, which is variously defined by different medical authorities. In general, the terms “overweight” and “obese” are labels for ranges of weight that are greater than what is generally considered healthy for a given height. The terms also identify ranges of weight that have been shown to increase the likelihood of certain diseases and other health problems. Applicants propose implanting the devices as described herein into a clinical survey group of obese patients in order to monitor weight loss. 
     The clinical studies will utilize the devices described above in conjunction with the following parameters. 
     Materials: 
     Silicone materials used include 3206 silicone for any shells, inflatable structures, or otherwise flexible hollow structures. Any fill valves will be made from 4850 silicone with 6% BaSo 4 . Tubular structures or other flexible conduits will be made from silicone rubber as defined by the Food and Drug Administration (FDA) in the Code of Federal Regulations (CFR) Title 21 Section 177.2600. 
     Purposes: 
     the devices are for human implant, 
     the devices are intended to occupy gastric space while also applying intermittent pressure to various and continually changing areas of the stomach; 
     the devices are intended to stimulate feelings of satiety, thereby functioning as a treatment for obesity. 
     General Implant Procedures: 
     The device is intended to be implanted transorally via endoscope into the corpus of the stomach. 
     Implantation of the medical devices will occur via endoscopy. 
     Nasal/Respiratory administration of oxygen and isoflurane to be used during surgical procedures to maintain anesthesia as necessary. 
     One exemplary implant procedure is listed below.
         a) Perform preliminary endoscopy on the patient to examine the GI tract and determine if there are any anatomical anomalies which may affect the procedure and/or outcome of the study.   b) Insert and introducer into the over-tube.   c) Insert a gastroscope through the introducer inlet until the flexible portion of the gastroscope is fully exited the distal end of the introducer.   d) Leading under endoscopic vision, gently navigate the gastroscope, followed by the introducer/over-tube, into the stomach.   e) Remove gastroscope and introducer while keeping the over-tube in place.   f) OPTIONAL: Place the insufflation cap on the over-tubes inlet, insert the gastroscope, and navigate back to the stomach cavity.   g) OPTIONAL: Insufflate the stomach with air/inert gas to provide greater endoscopic visual working volume.   h) Collapse the gastric implant and insert the lubricated implant into the over-tube, with inflation catheter following if required.   i) Under endoscopic vision, push the gastric implant down the over-tube with gastroscope until visual confirmation of deployment of the device into the stomach can be determined.   j) Remove the guide-wire from the inflation catheter is used.   k) If inflated: Inflate the implant using a standard BioEnterics Intragastric Balloon System (“BIB System”) Fill kit.   l) Using 50-60 cc increments, inflate the volume to the desired fill volume.   m) Remove the inflation catheter via over-tube.   n) Inspect the gastric implant under endoscopic vision for valve leakage, and any other potential anomalies. Record all observations.   o) Remove the gastroscope from over-tube.   p) Remove the over-tube from the patient.       

     End Point Criteria:
         Weight Loss   Comprehensive Metabolic Panel (CMP)   HbA1C   Lipid Panel   Tissue Samples/Response       

     Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. 
     Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the disclosure are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
     The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
     Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
     Certain embodiments are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. 
     Furthermore, references may have been made to patents and printed publications in this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety. 
     Specific embodiments disclosed herein may be further limited in the claims using “consisting of or” consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. 
     In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.