Patent Publication Number: US-8979876-B2

Title: Devices and methods for tissue restoration

Description:
PRIORITY 
     The present U.S. continuation-in-part patent application is related to, and claims the priority benefit of, U.S. patent application Ser. No. 12/861,251 filed Aug. 23, 2010, which is related to, claims the priority benefit of, and is a U.S. continuation-in-part application of, U.S. patent application Ser. No. 12/546,139, filed Aug. 24, 2009. The contents of each of these applications are hereby incorporated by reference in their entirety into this disclosure. 
    
    
     BACKGROUND 
     Organ and tissue surgical restoration are clinical techniques that may be applied to numerous different body tissues, ranging from blood vessels to whole organs. Conventionally, such surgical techniques require the use of incisions, pins, staples and/or significant sutures in order to alter the tissue&#39;s anatomy. For example, surgical gastric restoration often employed to treat obesity and typically involves the reorganization of the digestive tract. Conventional examples of such procedures involve attempts to either 1) restrict food intake into the body via a restrictive bariatric procedure (a “Restrictive Procedure”), or 2) alter the anatomy of the small intestine or divert the peristalsis of a person&#39;s normal food intake past the small intestine to decrease caloric absorption via a malabsorptive bariatric procedure, which is commonly known as a gastric bypass (a “Malabsorptive Procedure”). It is also known to combine the two procedures such that both of the aforementioned techniques are employed jointly. 
     Malabsorptive Procedures entail an intestinal bypass that results in the exclusion of almost all of the small intestine from the digestive tract. In most Malabsorbptive Procedures, a portion of the stomach or small intestine is removed from the digestive tract through a surgical procedure that requires cutting the digestive tissue and thereafter closing any holes or securing the newly formed anatomy with staples and/or sutures. Conversely, Restrictive Procedures generally involve the creation of a passageway extending from the upper portion of the stomach to the lower portion of the stomach in order to decrease the size of the organ and thus prevent the stomach from storing large amounts of food. Conventional Restrictive Procedures rely on the banding, suturing and/or stapling of the stomach to create a small pouch on the superior portion of the stomach near the gastroesophageal junction. 
     Combined operations consisting of Malabsorptive and Restrictive Procedures are the most common bariatric procedures performed today. An example of a combined procedure is the Extended (Distal) Roux-en-Y Gastric Bypass in which a stapling creates a small stomach pouch (approximately 15 to 20 cc) completely separated from the remainder of the stomach. In addition, the small intestine is divided just beyond the duodenum (the hollow tube connecting the stomach to the jejunum), re-arranged into a Y-configuration, and sutured to the small upper stomach pouch to enable the outflow of food therefrom through the newly formed “Roux limb.” 
     Accordingly, most digestive tract restoration procedures require that the stomach and/or tissue of the intestine is cut and thereafter sutured or stapled back together. As the digestive tract contains numerous enzymes, strong acids and multiple species of bacteria that assist with digestion, the perforation of an organ and/or tissue thereof is particularly problematic due to the likelihood of leakage therefrom and/or increased risk of serious infection. As such, conventional gastric surgical restoration procedures have high rates of post-operative complications that may require prolonged hospitalization and even additional operations, and are often irreversible and/or permanently affect the restored tissue and/or organ. Accordingly, a need exists for safe and effective devices and methods for restoring organs and tissue that are reversible and do not require cutting or penetrating the underlying tissue with significant sutures, staples and/or pins. 
     It will be appreciated that the foregoing examples are only provided as examples and that there are numerous other indications where intervention is necessary either to restore the underlying organ or tissue and/or to provide support thereto. 
     BRIEF SUMMARY 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device comprises a first engaging component and a second engaging component at least substantially parallel to one another, a first swivel arm, comprising a first fixed arm, a first expandable arm, and a first hub, wherein the first fixed arm is pivotally connected to the first engaging component at or near a first fixed arm first end and is coupled to the first hub at or near a first fixed arm second end, and wherein the first expandable arm is pivotally connected to the second engaging component at or near a first expandable arm first end and is connected to the first hub at or near a first expandable arm second end by way of a first hub bracket, a second swivel arm, comprising a second fixed arm, a second expandable arm, and a second hub, wherein the second fixed arm is pivotally connected to the first engaging component at or near a second fixed arm first end and is coupled to the second hub at or near a second fixed arm second end, and wherein the second expandable arm is pivotally connected to the second engaging component at or near a second expandable arm first end and is connected to the second hub at or near a second expandable arm second end by way of a second hub bracket, and wherein the first expandable arm and the second expandable are capable of movement relative to the first hub and the second hub respectively so that a distance between the first engaging component and the second engaging component may change relative to movement of the first expandable arm and the second expandable arm. In another embodiment, the first swivel arm is capable of rotation in a first direction, and wherein the second swivel arm is capable of rotation in an opposing second direction. In yet another embodiment, the first swivel arm and the second swivel arm are capable of rotation so that the first swivel arm, the second swivel arm, the first engaging component, and the second engaging component share a common linear axis. In an additional embodiment, the first swivel arm and the second swivel arm are capable of rotation so that the first swivel arm and the second swivel arm are substantially or fully perpendicular to the first engaging component and the second engaging component. In yet an additional embodiment, the first fixed arm is relatively shorter than the second fixed arm, and wherein the first expandable arm is relatively shorter than the second expandable arm. 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device further comprises a first arm flange at or near the first expandable arm second end, the first arm flange configured to limit expansion of the first expandable arm relative to the first fixed arm, and a second arm flange at or near the second expandable arm second end, the second arm flange configured to limit expansion of the second expandable arm relative to the second fixed arm. In an additional embodiment, the device is sized and shaped to fit within a laparoscopic bodily port. 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device further comprises a first strap positioned at a first end of the first engaging component and at a first end of the second engaging component, the first strap configured to limit movement of the first engaging component and the second engaging component when the first strap is coupled to the first engaging component and the second engaging component. In an additional embodiment, the first strap is fixedly coupled to one of the first end of the first engaging component or the first end of the second engaging component. In yet an additional embodiment, the first strap is coupled to one of the first end of the first engaging component or the first end of the second engaging component by way of at least one suture. In another embodiment, the first strap has at least one suture aperture defined therethrough, and wherein at least one of the first engaging component and the second engaging component has at least one plate aperture defined therethrough, the at least one suture aperture and the at least one plate aperture configured to permit a suture to be placed therethrough to couple the first strap to either the first engaging component or the second engaging component. 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device further comprises a first pad coupled to one or both of the first fixed arm and the first expandable arm, and a second pad coupled to one or both of the second fixed arm and the second expandable arm, wherein the first pad and the second pad are configured to engage at least a portion of a mammalian bodily organ positioned therebetween. In another embodiment, the first engaging component and the second engaging component are configured to engage a targeted tissue therebetween when the first swivel arm and the second swivel arm are in a configuration relatively perpendicular to the first engaging component and the second engaging component. In yet another embodiment, the first engaging component, the second engaging component, the first swivel arm, and the second swivel arm each comprise a material suitable to resist corrosion selected from the group consisting of polyurethane, polyethylene, polytetrafluoroethylene, polyaryletherketone, carbothane, tecothane, nitinol, silastic, titanium, and stainless steel. 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, each of the first engaging component and the second engaging component define one or more facets along at least part of a length of said engaging components, said facets providing a generally arcuate profile of said engaging components. In an additional embodiment, each of the first engaging component and the second engaging component comprise a configuration chosen from a straight bar configuration, a curved configuration, or a circular configuration. In yet an additional embodiment, the first engaging component and the second engaging component are flexible or semi-flexible. 
     In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device comprises a first engaging component and a second engaging component at least substantially parallel to one another, a first swivel arm, comprising a first fixed arm, a first expandable arm, and a first hub, wherein the first fixed arm is pivotally connected to the first engaging component at or near a first fixed arm first end and is coupled to the first hub at or near a first fixed arm second end, and wherein the first expandable arm is pivotally connected to the second engaging component at or near a first expandable arm first end and is connected to the first hub at or near a first expandable arm second end by way of a first hub bracket, a second swivel arm, comprising a second fixed arm, a second expandable arm, and a second hub, wherein the second fixed arm is pivotally connected to the first engaging component at or near a second fixed arm first end and is coupled to the second hub at or near a second fixed arm second end, and wherein the second expandable arm is pivotally connected to the second engaging component at or near a second expandable arm first end and is connected to the second hub at or near a second expandable arm second end by way of a second hub bracket, and a first strap positioned at one or both of a first end of the first engaging component and at a first end of the second engaging component, the first strap configured to limit movement of the first engaging component and the second engaging component when the first strap is coupled to the first engaging component and the second engaging component. wherein the first expandable arm and the second expandable are capable of movement relative to the first hub and the second hub respectively so that a distance between the first engaging component and the second engaging component may change relative to movement of the first expandable arm and the second expandable arm, and wherein the first swivel arm is capable of rotation in a first direction so that the first swivel arm, the second swivel arm, the first engaging component, and the second engaging component share a common linear axis, and wherein the second swivel arm is capable of rotation in an opposing second direction so that the first swivel arm and the second swivel arm are substantially or fully perpendicular to the first engaging component and the second engaging component. 
     In at least one embodiment of a method for restoring a targeted tissue of the present disclosure, the method comprises the steps of inserting an implantable restraining device into a body cavity of a mammalian body, the implantable restraining device comprising a first engaging component and a second engaging component at least substantially parallel to one another, a first swivel arm, comprising a first fixed arm, a first expandable arm, and a first hub, wherein the first fixed arm is pivotally connected to the first engaging component at or near a first fixed arm first end and is coupled to the first hub at or near a first fixed arm second end, and wherein the first expandable arm is pivotally connected to the second engaging component at or near a first expandable arm first end and is connected to the first hub at or near a first expandable arm second end by way of a first hub bracket, a second swivel arm, comprising a second fixed arm, a second expandable arm, and a second hub, wherein the second fixed arm is pivotally connected to the first engaging component at or near a second fixed arm first end and is coupled to the second hub at or near a second fixed arm second end, and wherein the second expandable arm is pivotally connected to the second engaging component at or near a second expandable arm first end and is connected to the second hub at or near a second expandable arm second end by way of a second hub bracket, advancing the implantable restraining device to a location within the mammalian body adjacent to a targeted tissue, swiveling the first swivel arm and the second swivel arm so that the first swivel arm and the second swivel arm are substantially perpendicular to the first engaging component and the second engaging component, and positioning the first engaging component and the second engaging component over the targeted tissue such that at least a portion of the targeted tissue is positioned therebetween, wherein when the targeted tissue expands in a direction between the first engaging component and the second engaging component, the targeted tissue exerts a force upon the first engaging component and the second engaging component so that the first expandable arm moves relative to the first hub and so that the second expandable arm moves relative to the second hub. In another embodiment, the targeted tissue is a stomach, and wherein expansion of the stomach, with said device positioned thereon, functionally divides the stomach into a first stomach portion and a second stomach portion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1 and 2  show perspective views of at least one embodiment of a restraining device for restoring and/or supporting a tissue or organ of the present disclosure; 
         FIG. 3A  shows a top view of at least one embodiment of a restraining device for restoring and/or supporting a tissue or organ according to the present disclosure; 
         FIGS. 3B through 3E  show various embodiments of engaging components according to the present disclosure; 
         FIG. 4A  shows a side view of the restraining device of  FIGS. 1A and 1B  applied in a longitudinal fashion to a stomach according to the present disclosure; 
         FIG. 4B  shows a cross-sectional view of a restored stomach along line A-A of  FIG. 4 ; 
         FIGS. 5A through 5D  show various embodiments of restraining devices positioned about a stomach according to the present disclosure; 
         FIG. 6  shows a flow chart of a method for laparoscopically delivering embodiments of the restraining device disclosed herein to a targeted tissue according to the present disclosure; 
         FIGS. 7A ,  7 B, and  8  show various embodiments of a restraining device comprising one or more struts according to the present disclosure; 
         FIG. 9  shows an exemplary embodiment of a restraining device comprising two springs and a mesh curtain according to the present disclosure; 
         FIG. 10  shows an exemplary embodiment of a restraining device comprising a pliable junction according to the present disclosure; 
         FIG. 11  shows a restraining device positioned within a laparoscopic port according to the present disclosure; 
         FIGS. 12A ,  12 B,  13 A, and  13 B show various embodiments of a restraining device comprising a coupler according to the present disclosure; 
         FIGS. 14A and 14B  show exemplary embodiments of a restraining device comprising a coupler and a coupler pivot according to the present disclosure; 
         FIGS. 15A and 15B  show exemplary embodiments of an apparatus for delivering a restraining device according to the present disclosure; 
         FIGS. 16A and 16B  show exemplary embodiments of an apparatus for delivering a restraining device comprising a coupler according to the present disclosure; 
         FIGS. 17A and 17B  show additional exemplary embodiments of an apparatus for delivering a restraining device according to the present disclosure; 
         FIG. 18  shows an exemplary embodiment of an apparatus perpendicularly engaging a restraining device according to the present disclosure; 
         FIG. 19  shows a flow chart of a method for laparoscopically removing embodiments of the restraining device disclosed herein from a targeted tissue according to the present disclosure; 
         FIG. 20  shows a perspective view of at least another embodiment of a restraining device for restoring and/or supporting a tissue or organ of the present disclosure; 
         FIG. 21  shows an exemplary embodiment of a restraining device positioned about a stomach according to the present disclosure; 
         FIG. 22  shows steps of an exemplary method of inserting, delivering, and placing a restraining device about a targeted tissue according to the present disclosure; 
         FIG. 23  shows a perspective view of at least another embodiment of a restraining device for restoring and/or supporting a tissue or organ of the present disclosure; 
         FIG. 24  shows a side view of the embodiment of a restraining device shown in  FIG. 23 ; 
         FIG. 25  shows a perspective view of an embodiment of an adjustment rod of the present disclosure; 
         FIG. 26  shows a side view of the embodiment of an adjustment rod shown in  FIG. 25 ; 
         FIG. 27  shows a side view of an embodiment of an adjustment rod coupled to at least another component of an exemplary restraining device of the present disclosure; 
         FIG. 28  shows another perspective view of the embodiment of a restraining device shown in  FIG. 23 ; 
         FIG. 29  shows steps of another exemplary method of inserting, delivering, and placing a restraining device about a targeted tissue according to the present disclosure; 
         FIG. 30  shows a perspective view of an exemplary embodiment of a restraining device of the present disclosure in a relatively open configuration; 
         FIG. 31  shows a perspective view of an exemplary embodiment of a restraining device of the present disclosure in a relatively open configuration; 
         FIGS. 32 and 33  show top views of an exemplary embodiment of a restraining device of the present disclosure; 
         FIG. 34  shows a side view of an exemplary embodiment of a restraining device of the present disclosure in a relatively closed configuration; 
         FIG. 35  shows a perspective view of an exemplary embodiment of a restraining device of the present disclosure in a relatively closed configuration; 
         FIG. 36  shows a side view of an exemplary swivel arm of the present disclosure; 
         FIG. 37  shows a perspective view of an exemplary swivel arm of the present disclosure; 
         FIG. 38  shows a side view of another exemplary swivel arm of the present disclosure; 
         FIG. 39  shows a perspective view of another exemplary swivel arm of the present disclosure; and 
         FIGS. 40 ,  41 , and  42  show exemplary embodiments of restraining devices of the present disclosure positioned about a stomach. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended. 
       FIGS. 1 and 2  show perspective views of at least one embodiment of a restraining device  10  for restoring a tissue or organ. In at least one embodiment of the restraining device  10 , the restraining device  10  comprises an implantable device and does not require substantial sutures, staples or pins to be secured on the targeted tissue or organ of interest. Further, the restraining device  10  described herein is configured to loosely, albeit securely, engage to the targeted tissue such that the underlying tissue is either uncompressed or only loosely compressed. The various embodiments of the restraining device  10  described herein may be available for temporary or chronic placement within a patient&#39;s body, and the restoration procedures performed through the use of an exemplary device  10  are reversible through minimally invasive procedures. 
     As shown in  FIGS. 1 and 2 , at least one embodiment of the restraining device  10  comprises a first engaging component  12  and a second engaging component  16 . The first engaging component  12  may comprise a first shape and the second engaging component  16  may comprise a second shape that corresponds to at least a portion of the first shape of the first engaging component  12 . For example, and without limitation, the first and second engaging components  12 ,  16  may be configured in a bar configuration as shown in  FIGS. 1 and 2 . Alternatively, the first and second engaging components  12 ,  16  may be configured in a contoured, circular or any other configuration suitable for use as referenced herein. Additionally, the first and second engaging components  12 ,  16  may be configured such that the shape of each of the components  12 ,  16  defines an interior area (not shown). It will be understood that the first and second engaging components  12 ,  16  of an exemplary restraining device  10  may be configured in any shape and may also be flexible, semi-flexible, or articulated. Furthermore, it is contemplated that a clinician may select the desired configuration of the components  12 ,  16  of the restraining device  10  based on the particular patient to be treated and/or pursuant to the specific application for which the restraining device  10  will be used to ensure that the restraining device  10  appropriately conforms to the tissue or organ of interest. For example, an exemplary embodiment of a restraining device  10  of the present disclosure may comprise first and second engaging components  12 ,  16  having a width of approximately 14 mm and a length of approximately 120 mm. In at least one additional embodiment, the first and second engaging components  12 ,  16  may have a width between 5 mm and 15 mm, and may have a length between 30 mm and 200 mm, with any number of potential widths and lengths contemplated by the present disclosure suitable for use with an exemplary restraining device  10  of the present disclosure. 
     In at least one embodiment of a restraining device  10  of the present disclosure, and as shown in  FIG. 2 , the first engaging component  12  of the restraining device  10  comprises a proximal end  13 , a body having a first side  12 A and a second side  12 B, and a distal end  14 . The first side  12 A of the first engaging component  12  is configured to be positioned adjacent to or in contact with a tissue or organ of interest. Likewise, the second engaging component  16  comprises a proximal end  17 , a body having a first side  16 A and a second side  16 B, and a distal end  18 . The first side  16 A of the second engaging component  16  is configured to be positioned adjacent to or in contact with the tissue or organ of interest. 
     The first engaging component  12  and the second engaging component  16  each comprise a material suitable to resist corrosion, such as and without limitation polyurethane, polyethylene, polytetrafluoroethylene (“PTFE”), nitinol, silastic, titanium, stainless steel or any other material suitable for use in the medical arts that is corrosion resistant. Accordingly, the restraining device  10  can withstand chronic placement within a body without the risk of deterioration. In at least one embodiment, the first and second engaging components  12 ,  16  of the restraining device  10  are comprised of ultra high density polyethylene. 
     The first and second engaging components  12 ,  16  of the restraining device  10  may be coupled to one or more springs  22 , wherein the one or more springs  22  engage the first and second engaging components  12 ,  16  at their distal ends  14 ,  18  and proximal ends  13 ,  17 . Springs  22 , as well as struts  700  (as shown in  FIGS. 7A and 7B ) and couplers  1200  (as shown in  FIGS. 14A through 16B ), as referenced herein, may be generally referred to as “connector(s)” as they connect, in various embodiments, first engaging components  12  and second engaging components  16  of various restraining devices  10  of the present disclosure. The springs  22  may comprise torsion springs or any other type of spring known or developed that is capable of supporting the first and second engaging components  12 ,  16  a prescribed distance apart from each other, which may vary depending upon the orientation of the springs  22  about the first and second engaging components  12 ,  16 . As described in more detail herein, due to the configuration and resistance of the springs  22 , the first and second engaging components  12 ,  16  of the restraining device may be held such that little or no space is defined between the first sides  12 A,  16 A of the first and second engaging components  12 ,  16  based upon a first orientation of springs  22 , and the first and second engaging components  12 ,  16  of the restraining device  10  may be held such that an interior space  70  is defined between the first sides  12 A,  16 A of the first and second engaging components  12 ,  16  based upon a second orientation of springs  22 . 
     Further, each of the one or more springs  22  may have any number of coils configured in any fashion, provided the spring configuration and stiffness are suitable for the desired application of the restraining device  10 . For example, and without limitation, in at least one embodiment each of the one or more springs  22  comprises a torsion, resistance spring having three (3) closely-coiled coils. It will be appreciated that, in practice, a clinician may alter the number of coils and/or configuration of each spring  22  to achieve to a desired flexibility or rigidity of the springs  22  and, in this manner, the restraining device  10  may be customized for a particular patient and/or application for which the restraining device  10  is to be applied. 
     Each of the springs  22  of the restraining device  10  may comprise at least one rod  24  extending from each of the ends of its coils. The length of each rod  24  may be selected depending on the particular application for which the restraining device  10  is to be applied. As shown in the exemplary embodiments of a restraining device  10  in  FIGS. 1 and 2 , each rod  24  is coupled with either the first or second engaging component  12 ,  16 . For example, as shown in  FIG. 2 , the first rod  24  of one of the springs  22  may be coupled with the second side  12 B of the first engaging component  12  at or near a location on the distal end  14  of the first engaging component  12 , and the second rod  24  of the same spring  22  may be coupled with the second side  16 B of the second engaging component  16  at or near a location on the distal end  18  of the second engaging component  16 . Furthermore, the rods  24  facilitate the formation of the interior space  70  (as shown in  FIG. 2 ) between the first and second engaging components  12 ,  16  by holding the first and second engaging components  12 ,  16  in accordance with the tension of the springs  22 . 
     The springs  22  of the restraining device  10  may comprise any dimensions so long as the restraining device  10  is of a sufficient size to move through a laparoscopic port and the springs  22  are capable of holding the first side  12 A of the first engaging component  12  and the second side  16 A of the second engaging component  16  a distance apart when the restraining device  10  has a configuration whereby the springs  22  are positioned about the first and second engaging components  12 ,  16 . For example, springs  22  may have a “first” configuration as shown in  FIG. 1 , whereby springs  22  and the first and second engaging components  12 ,  16  are oriented in the same or substantially the same direction/plane so that the restraining device  10  may pass through a laparoscopic port. In such a first configuration, springs  22  engage the first and second engaging components  12 ,  16  so that the first and second engaging components  12 ,  16  either engage one another or have a relatively small space between them. Springs  22  may have a “second” configuration, for example and as shown in  FIG. 2 , when springs  22  are rotated about first and second engaging components  12 ,  16  and are not in the same direction/plane as the configuration of restraining device shown in  FIG. 1 . In such a second configuration, the first and second engaging components  12 ,  16  may define an interior space  70  when the restraining device  10  is “at rest,” with the interior space  70  increasing upon positioning the restraining device  10  around a stomach  100  (as shown in  FIGS. 4A through 5A ) for example, and potentially increasing only slightly further upon introduction of food, for example, into the stomach  100 . 
     Accordingly, the dimensions of the springs  22  may dictate the native value of the interior space  70  between the first and second engaging components  12 ,  16 . In at least one embodiment, the springs  22  may comprise a maximum outside diameter that is less than about  14  millimeters to allow a “collapsed” or “compressed” restraining device  10  to pass within a 15 mm diameter abdominal port. Furthermore, each of the springs  22  may comprise any material having a strength that is consonant with the application for which the restraining device  10  will be employed. In at least one embodiment, the springs  22  are comprised of a rigid or semi-rigid material that is suitable to resist corrosion, such as and without limitation, polyurethane, PTFE, nitinol, silastic, titanium, stainless steel or any other material suitable for use in the medical arts that is corrosion resistant. 
     Referring back to  FIG. 2 , and as previously described, the springs  22  of the restraining device  10  are biased to maintain the first and second engaging components  12 ,  16  at a prescribed distance apart under a native, and as described above, “second” configuration. In this manner, when no pressure is applied to an exemplary restraining device  10 —or when the restraining device  10  is “at rest”—the interior space  70  having a prescribed value is formed between the first and second engaging components  12 ,  16 . The value of the interior space  70  may, in at least one embodiment, correlate with the outside diameter of the springs  22 , minus the thickness of the first and second engaging components  12 ,  16 . It will be understood that the value of the interior space  70  can be manipulated by a clinician depending on the thickness of tissue and/or organ to be treated or other factors. For example, to achieve an interior space  70  having a larger prescribed value, the outer diameter of the spring  22  may be increased and/or the thickness of the first and/or second engaging components  12 ,  16  may be adjusted. Accordingly, a clinician can easily modify the restraining device  10  such that it may be optimally configured for a particular application on a particular tissue. 
     Due to the nature of the springs  22  (depending on the material and rigidity selected), the first and second engaging components  12 ,  16  may exhibit some degree of “give” such that the first and second engaging components  12 ,  16  are capable of moving relative to each other when pressure is applied. While the first and second engaging components  12 ,  16  are biased to return to their resting position such that the interior space  70  is substantially equivalent to its prescribed/native value when no pressure is applied to the springs  22 , the springs  22  of the restraining device  10  are also capable of allowing the first and second engaging components  12 ,  16  to move in response to force applied thereto. For example, and without limitation, if a force is applied against the first sides  12 A,  16 A of the first and second engaging components  12 ,  16 , this force is translated to the springs  22  which enables the components  12 ,  16  of the restraining device  10  to move apart such that the interior space  70  is increased. Furthermore, if a force is applied directly to the springs  22  such that the coils are twisted about their axis in a direction counter to the coil configuration, similar to the above-listed example, the resultant effect on the restraining device  10  is that the first and second engaging components  12 ,  16  are moved apart and the interior space  70  is increased. However, due to the inherent bias provided by the springs  22  of the restraining device  10 , after the pressure affecting the springs  22  is released, the springs  22 —and thus the components  12 ,  16 —return to their resting positions such that the interior space  70  reverts to its original prescribed value. It will be appreciated that the specific configuration and/or materials comprising each of the springs  22  may be selected to achieve the desired degree of elasticity depending on the application for which the restraining device  10  is to be applied. 
     As shown in  FIG. 2 , each rod  24  of spring  22  is rotatably coupled with the relevant component  12 ,  16  of the restraining device  10  such that each of the rods  24  is capable of pivotal movement with respect to the relevant component  12 ,  16  of the restraining device  10 . The rotational coupling of the rods  24  with the first and second engaging components  12 ,  16  may be achieved through any means known in the art. For example and without limitation, the end of each rod  24  may comprise a pin that is capable of insertion into and rotation within a hole formed within the respective second side  12 B,  16 B of the applicable component  12 ,  16 . 
     As each of the rods  24  is coupled with a spring  22 , when the rods  24  rotate with respect to the components  12 ,  16 , this effectively enables the respective spring  22  to move in an orbital manner with respect to the proximal or distal end of the restraining device  10 . Accordingly, the springs  22  are capable of rotating between a position that is substantially parallel with the first and second engaging components  12 ,  16  (as shown in  FIG. 1 , referred to as a “first” configuration herein) and a position that is substantially perpendicular to the first and second engaging components  12 ,  16  (as shown in  FIG. 2 , referred to as a “second” configuration). 
     The position of the springs  22  relative to the first and second engaging components  12 ,  16  has the potential to significantly affect the overall width of the restraining device  10 . For example and without limitation, when the springs  22  are positioned in the substantially perpendicular position (i.e., a “second” configuration), the restraining device  10  may have a width that is more than twice the width of the same restraining device  10  when its springs  22  are positioned in the substantially parallel position. Accordingly, the rotational coupling of the rods  24  with the first and second engaging components  12 ,  16  provides a clinician with the ability to manipulate the overall width of the restraining device  10  during laparoscopic delivery and/or implantation and further enables the restraining device  10  to be applied to tissues and/or organs having a length that is longer than the length of the restraining device  10  (as the proximal ends  13 ,  17  and the distal ends  14 , 18  of the first and second engaging components  12 ,  16  of the restraining device  10  are not obstructed by the springs  22 ). In at least one embodiment, the widest part of the restraining device  10  is less than about  15  millimeters when the springs  22  are in the substantially parallel position such that the restraining device  10  can be easily inserted into a body cavity through a 15 millimeter trocar or port. 
     Now referring to  FIG. 3A , a top view of at least one embodiment of a restraining device  10  of the present disclosure is shown. Here, the first and/or second engaging components  12 ,  16  of the restraining device  10  further comprise one or more pads  30  extending therefrom. As shown in  FIG. 3A , the one or more pads  30  may extend in a perpendicular fashion from the second side(s)  12 B,  16 B of the components  12 ,  16  and/or in a lateral fashion from the components  12 ,  16 . Each of the pads  30  are comprised of a flexible material and configured to provide an anchor through which sutures or any other type of anchoring device may be inserted. For example, and in at least one embodiment, one or more pads  30  may be comprised of polyurethane or any other material that is capable of securely holding sutures or another type of anchoring device therein. One or more sutures may be placed within suture apertures  32  as shown in  FIG. 3A , whereby said suture apertures  32  may be positioned along pads  30  and/or one or both of components  12 ,  16  as shown in  FIG. 3A . Accordingly, after the first and second engaging components  12 ,  16  are properly positioned about a targeted tissue or organ, sutures may be inserted through suture apertures  32  and secured to a superficial layer of the underlying targeted tissue or organ to assist in anchoring the restraining device  10  in the proper location thereon. 
       FIGS. 3B-3E  show various embodiments of first engaging component  12  and/or second engaging component  16  with various features to facilitate suturing and/or connection of first engaging component  12  to second engaging component  16 .  FIG. 3B  shows an exemplary embodiment if a first and/or second engaging component  12 ,  16  comprising suture apertures  32  positioned therethrough. Suture apertures  32  are not limited to positioning near one or more of the ends of said first and/or second engaging component  12 ,  16 , as such suture apertures  32  may be positioned along first and/or second engaging component  12 ,  16  as desired. 
       FIG. 3C  shows an exemplary embodiment of a first and/or second engaging component  12 ,  16  comprising one or more strings  34  affixed thereto. In the exemplary embodiment shown in  FIG. 3C , two strings  34  are shown at or near the ends of first and/or second engaging component  12 ,  16 , noting, however, that one, two, or more strings  34  may be affixed thereto and positioned as desired. In an exemplary embodiment of a restraining device  10 , and as shown in  FIG. 4B , the first engaging component  12  and the second engaging component  16  may each comprise at least one string  34 , whereby said strings  34  may be connected to one another to facilitate a desired placement of restraining device  10  about a stomach  100 . 
     Additional embodiments of exemplary first and/or second engaging components  12 ,  16  are shown in  FIGS. 3D and 3E . As shown in  FIG. 3D , first and/or second engaging component  12 ,  16  comprises one or more suture members  36  affixed thereto, with said suture members defining an aperture to which a suture (not shown) or other restraining component may be affixed thereto.  FIG. 3E  shows an exemplary first and/or second engaging component  12 ,  16  of the present disclosure comprising pads  30  positioned at or near each end of the first and/or second engaging component  12 ,  16  with each pad  30  defining a suture aperture  32  therethrough. Additional embodiments of first and/or second engaging component  12 ,  16  comprising features to allow for a suture or other restraining component to be positioned therethrough are also contemplated by the present disclosure. For purposes of the present disclosure, the term “suturing elements” shall mean any number of elements for introducing a suture into the first and/or second engaging component  12 ,  16  and/or one or more pads  30  affixed thereto, including, but not limited to, one or more apertures  32 , strings,  34 , and/or suture members  36 . In addition, any number of the features of the various exemplary first and/or second engaging components  12 ,  16  shown in  FIGS. 3A-3E  may appear in any number of embodiments of restraining devices  10  of the present disclosure. 
     In operation, the restraining device  10  may be applied to an organ or tissue of interest in order to restore the underlying tissue or organ into a desired configuration and/or provide support to the same. As discussed in further detail below, the restraining device  10  may be used for temporary or chronic implantation within a body without the risk of the first and second engaging components  12 ,  16  migrating through or damaging the underlying tissue. Furthermore, because the restraining device  10  does not require that the underlying tissue be punctured in any significant manner to achieve restoration and/or provide support thereto, implantation of the restraining device  10  is entirely reversible and, if desired, the restraining device  10  may be easily removed from the organ or tissue of interest through a laparoscopic procedure. 
     As previously described, the specifications of the restraining device  10  may be modified to achieve a desired result. For example, and without limitation, the dimensions of the components  12 ,  16  and/or the springs  22  may be chosen for a particular application and/or based on the patient. Accordingly, while certain embodiments of the restraining device  10  may be described in connection with particular tissues or organs, it will be appreciated that any of the embodiments of the restraining device  10  described herein may also be applied to any tissue or organ of interest in a similar manner and use of the particular embodiments of the restraining device  10  in lieu of others may be determined based on the patient&#39;s specifications, the specific application, and/or the tissue or organ in question. 
     In practice, an exemplary restraining device  10  is capable of restoring and/or supporting an underlying tissue while avoiding constriction and the excessive compression thereof. For example, the restraining device  10  may be applied to a stomach  100  as shown in  FIGS. 4A and 4B . In at least one embodiment, and as shown in  FIG. 4A , the springs  22  of the restraining device  10  are rotated to the substantially perpendicular position such that the interior space  70  is increased between the first and second engaging components  12 ,  16 . Thereafter, the restraining device  10  may be advanced over the stomach  100  such that, for example, the first side  12 A of the first engaging component  12  is positioned adjacent to the anterior wall of the stomach  100  and the first side  16 A of the second bar  16  is positioned adjacent to the posterior wall of the stomach  100 . While the restraining device  10  is shown in  FIG. 4A  in a longitudinal placement with respect to the stomach  100 , it will be understood that the restraining device  10  may alternatively be positioned in a horizontal configuration or an angular configuration with respect to the stomach  100 . 
     After the first and second engaging components  12 ,  16  are positioned in the desired location with respect to the stomach  100 , the overall interior space  70  may either comprise its original native interior space  70  or a relatively larger interior space  70  due to the positioning of the restraining device  10  about the stomach  100 . Therefore, various embodiments of restraining device  10  do not operate to “clamp” the stomach  100  or any other tissue or organ, as restraining device  10  merely operates, when positioned around a stomach  100 , to provide a limited pressure, if any, to maintain a native size/shape of at least a portion of the stomach  100 . For example, and depending upon the prescribed value of the interior space  70  as desired by a clinician, the configuration of the springs  22  can be modified to achieve a restraining device  10  that either does not compress, or only loosely compresses, the sandwiched tissue between the first and second engaging components  12 ,  16 . In a preferred embodiment, restraining device  10 , when positioned about a stomach  100 , does not provide any meaningful compressive pressure upon the stomach  100 , and may be held in place, for example, using one or more sutures as referenced herein. In this manner, the restraining device  10  can be employed to reversibly restore an organ or tissue without forming adhesions thereon and/or permanently restoring the same. 
     In at least one embodiment, and depending on the configuration of the springs  22 , the springs  22  may exhibit enough elasticity to enable the first and second engaging components  12 ,  16  to move to some degree in conjunction with any movement of a tissue or organ positioned between the first and second engaging components  12 ,  16  of the restraining device  10 . In this manner, the springs  22  can allow, for example, the restraining device  10  to accommodate any inherent movement in the stomach  100  such that application of the restraining device  10  does not completely inhibit the normal digestive function of the same. For example, the introduction of food into the stomach  100  may cause the outer dimensions of the stomach  100  to expand, whereby stomach  100  exerts a pressure upon restraining device  100 . Furthermore, the restraining device&#39;s  10  ability to accommodate any inherent movement in the underlying organ and/or tissue increases the likelihood that the restraining device  10  will remain in its desired location on the tissue and/or organ without sheering off or sliding therefrom. 
     In the event it is desired that the restraining device  10  is further secured to the underlying tissue, and as previously referenced herein, a clinician can employ sutures to assist with the secure implantation of the restraining device  10  in the desired location. In the at least one embodiment of the restraining device  10  comprising the one or more pads  30 , a clinician can secure the one or more pads  30  of the first and second engaging components  12 ,  16  to the underlying tissue through the use of superficial sutures. In this manner, the superficial sutures can be affixed through the one or more pads  30  and the surface of the underlying tissue such that the one or more pads  30  assist with anchoring the restraining device  10  in position on the tissue of interest. Conversely, and in at least one embodiment, sutures may be introduced directly to the first and/or second engaging components  12 ,  16  to secure a restraining device to a tissue or organ of interest as shown in  FIGS. 3A-3E . 
       FIG. 4B  shows a cross-sectional view of the stomach  100  of  FIG. 4A  taken along A-A. As shown in  FIG. 4B , when the first and second engaging components  12 ,  16  of the restraining device  10  are longitudinally positioned on the stomach  100 , the stomach  100  is “divided” into two portions—a first stomach portion  110  and a second stomach portion  112  as shown in  FIGS. 4A and 4B . In the embodiment shown in  FIGS. 4A and 4B , the first stomach portion  110  is relatively smaller than the second stomach portion  112 . However, and as shown in  FIG. 5A , the first stomach portion  110  and the second stomach portion  112  may be approximately the same size. 
     As the first stomach portion  110  receives ingested matter directly from the gastroesophageal junction  99  as shown in  FIG. 4A , the placement of the restraining device  10  as shown in  FIG. 4B  thus inhibits the majority of ingested matter from moving into the second stomach portion  112 . Instead, and in at least one embodiment, such ingested matter is directed through the smaller, first stomach portion  110  and into the pyloric canal  101  (as shown in  FIG. 4A ) where a significant portion of the ingested matter is evacuated from the stomach  100 . Due to the size of the first stomach portion  110 , the amount of food that the patient can consume at one time is significantly reduced and satiety is more quickly achieved. 
     While the delineation formed by the restraining device  10  between the first stomach portion  110  and the second stomach portion  112  is not leak-proof, the interior space  70  created between the first and second engaging components  12 ,  16  comprises an area that is less than the diameter of a fully extended stomach  100  (as shown in  FIG. 4B ). Accordingly, when the restraining device  10  is applied in a longitudinal fashion to a stomach  100 , restraining device  10  provides support to the anterior and posterior walls of the stomach  100 , with the expansion of stomach  100  exerting a force onto the first and second engaging components  12 ,  16  of restraining device  10 , this preventing stomach  100  distension in that area. In this manner, most of the food matter received into the first stomach portion  110  through the gastroesophageal junction  99  is maintained therein and the patient exhibits the sensation of satiety earlier. 
     Referring back to  FIG. 4A , and in at least one exemplary embodiment, because the restraining device  10  does not extend along the entire length of the stomach  100 , an outflow tract  114  is formed caudally of the restraining device  10 . This outflow tract  114  allows the portion of ingested matter that flows from the gastroesophageal junction  99  into the second stomach portion  112  to be evacuated from the stomach  100  in a controlled manner and to proceed through normal digestion. In addition, the outflow tract  114  allows any food matter or enzymes residing within the second stomach portion  112  to evacuate the stomach  100 . 
     Additional embodiments of restraining devices  10  of the disclosure of the present application positioned about a stomach  100  are shown in  FIGS. 5B and 5C . In the exemplary embodiment shown in  FIG. 5B , restraining device  10  comprises first and second engaging components  12 ,  16  which are “longer” than those shown in  FIG. 5A , whereby distal end  14  of first engaging component  12  and distal end  18  of second engaging component  16  extend past stomach  100 . In this exemplary embodiment, strings  34  affixed to first and second engaging components  12 ,  16  may be connected/tied to each other after restraining device  10  has been positioned about a stomach, maintaining restraining device  10  in place. 
       FIG. 5C  shows restraining device  10  positioned about stomach  100  viewed in the direction of the arrow shown in  FIG. 5B . As shown in  FIG. 5B , the tying/coupling together of strings  34  at the distal ends  14 ,  18  of first and second engaging components  12 ,  16  may cause portions of the first and second engaging components  12 ,  16  to angle towards one another as shown in  FIG. 5C . In this particular embodiment, first and second engaging components  12 ,  16  are flexible or semi-flexible, and the positioning of restraining device  10  about stomach  100  serves to isolate the first stomach portion  110  from fundus  90  and greater curvature  92 . This “funnel” effect, in addition to the embodiment of a restraining device  10  shown in  FIG. 5D  below, may also be accomplished by having springs  22  with relatively shorter rods  24  (or relatively smaller struts  700  as referenced in various embodiments herein) at one end of restraining device  10 , and by having springs  22  with relatively longer rods  24  (or relatively larger struts  700  as referenced in various embodiments herein) at the other end of restraining device  10 . In addition as to being substantially rigid as shown in  FIGS. 1 and 2 , and as shown in  FIG. 5C , first and second engaging components  12 ,  16  may have substantially rigid center portions and one or more flexible or semi-flexible ends, or first and second engaging components  12 ,  16  may be flexible or semi-flexible along the entirety of said components  12 ,  16 . 
     An additional embodiment of a restraining device  10  of the present disclosure positioned about stomach  100  is shown in  FIG. 5D . As shown in  FIG. 5D , and as also discussed herein regarding  FIG. 10 , restraining device  10  further comprises a pliable junction  1000  positioned within the first engaging component  12  and second engaging component  16 , effectively “splitting” each component, whereby each “split” component is connected to one another by way of a flexible structure  1002 . As shown in  FIG. 5D , flexible structure  1002  may comprise a PTFE band or a PTFE mesh, for example, whereby any potential embodiment of flexible structure  1002 , using one or more pliable materials disclosed herein or otherwise known in the art, allows the relatively or fully rigid first engaging component  12  and second engaging component  16  to better fit the stomach, allowing the patient, for example, to bend the stomach when restraining device  10  is positioned thereon. 
     Approximating first and second engaging components  12 ,  16 , as shown in  FIGS. 5B ,  5 C, and  5 D, and as identified during internal testing of exemplary restraining devices  10  of the present disclosure, leads to reduced food intake (65-70% of normal food intake) as compared to positioning restraining device  10  about stomach  100  without approximating first and second engaging components  12 ,  16  toward one another as shown in  FIG. 4A  (80-85% of normal food intake). This approximation also assists with the prevention of a fistula so that the food may move down the pouch (first stomach portion  110 ) along antrum  94  as opposed to shunted to the fundus  90  of stomach  100 . 
     As described herein, application of the restraining device  10  allows a clinician to restore a targeted tissue, such as a stomach  100 , while avoiding constriction and excessive compression of the same. Further, the various embodiments described herein allow a clinician to tailor the restraining device  10  to multiple restoration applications and various different types of tissues. Permanent restoration of the tissue is avoided, which prevents adhesions from developing in the underlying targeted tissue and allow for the complete reversal of the restoration procedure. Additionally, the restraining device  10  is simple to deliver and, as such, the device  10  may be used in conjunction with other techniques or surgical procedures. 
     Regarding the application of the restraining device  10  to the stomach  100 , use of the restraining device  10  in the treatment of obesity avoids the nutritional and metabolic deficiencies observed after Malabsorptive Procedures because the digestive process may continue within the stomach as with a native stomach  100 . In addition, the restraining device  10  does not require more than superficial punctures to the underlying tissue, nor does it employ pins, staples or significant sutures which may lead to dehiscence or fistula formation, or produce the degree of regurgitation and vomiting observed in connection with conventional methods used to treat obesity. Moreover, each of the embodiments described herein may be inserted into the body cavity laparoscopically, thereby decreasing the patient&#39;s stress associated with the procedure and the patient&#39;s recovery time. It will be recognized that any of the devices described herein may be employed in combination with other conventional bariatric procedures. 
     Now referring to  FIG. 6 , a flow chart of a method  300  for laparoscopically delivering the restraining device  10  is shown. For ease of understanding, the steps of the related methods described herein will be discussed relative to the components of an exemplary restraining device  10 . Furthermore, while the methods described herein are described in connection with embodiments of the restraining device  10  and an exemplary delivery device, it will be appreciated that various additional devices may be used to facilitate the laparoscopic delivery of the restraining device  10  such as a camera, light and/or a device for delivering a gas to a targeted area. 
     At step  302 , the first and second engaging components  12 ,  16  of restraining device  10  are advanced laparoscopically into the patient&#39;s body. In at least one embodiment, the restraining device  10  may be inserted through a  15  millimeter cannula under insufflation into the appropriate cavity of the patient&#39;s body. This may be achieved through use of an exemplary delivery device known in the art. At this step  302 , the springs  22  of the restraining device  10  are positioned in the substantially parallel position such that the overall diameter of the restraining device  10  is sufficiently narrow for insertion into the body. 
     At step  304  the restraining device  10  is advanced to a location adjacent to a targeted tissue. In the at least one embodiment of the method  300  where an exemplary delivery device is employed to facilitate delivery of the restraining device  10  to the targeted tissue, at step  304  the restraining device  10  is advanced out of the delivery device and into the body cavity. After the restraining device  10  is no longer positioned within an exemplary delivery device, the delivery device may be withdrawn from the body cavity at this step  304  or as desired by the clinician. 
     At step  306 , the springs  22  of the restraining device  10  are rotated from the substantially parallel position to the substantially perpendicular position, separating the first and second engaging components  12 ,  16  from one another to a native interior space  70 . Step  306  may be performed using any number of standard laparoscopic tools known in the art useful to pull and grasp portions of a tissue or a device. In this manner, neither the proximal ends  13 ,  17  nor distal ends  14 ,  18  of the first and second engaging components  12 ,  16  of the restraining device  10  are blocked by the springs  22  and/or rods  24 , and the first and second engaging components  12 ,  16  may be advanced over a targeted tissue having a length that is greater than the overall length of the first and second engaging components  12 ,  16 . 
     At step  308 , under fluoroscopic, direct camera control or otherwise, the restraining device  10  is advanced over the targeted tissue. In at least one embodiment, and at step  308 , the first side  12 A of the first engaging component  12  is positioned adjacent to the desired surface of the targeted tissue and the first side  16 A of the second engaging component  16  is positioned adjacent to an opposite side of the targeted tissue. As the first and second engaging components  12 ,  16  of the restraining device  10  are positioned adjacent to opposite sides of the targeted tissue, at this step  308  the targeted tissue is positioned within the interior space  70  formed between the first and second engaging components  12 ,  16 . Accordingly, while the targeted tissue may experience some compressional force exerted by the first and second engaging components  12 ,  16  of the restraining device  10 , the majority of the pressure upon the first and second engaging components  12 ,  16  is provided by distension/expansion of the targeted tissue (for example, expansion of a stomach  100  when food is introduced therein). Further, due to the configuration and composition of the restraining device  10 , the restraining device  10  can remain within the patient&#39;s body for as long as the restoration or support treatment delivered thereby is desired. 
     If preferred, in at least one embodiment of the restraining device  10  that further comprises one or more pads  30  coupled with the first and/or second engaging components  12 ,  16 , the method  300  may advance from step  308  to step  310 . At step  310 , a clinician can employ sutures to further anchor and secure the restraining device  10  in the desired position on the targeted tissue. These sutures need only superficially puncture the underlying tissue and therefore are not associated with the negative effects associated with suturing, stapling and/or the insertion of pins used in conventional methods. 
     Additional embodiments of restraining devices  10  of the disclosure of the present application is shown in  FIGS. 7A and 7B . As shown in  FIGS. 7A and 7B , restraining device  10  comprises a first engaging component  12  and a second engaging component  16 , whereby the first engaging component  12  and second engaging component  16  are coupled to one another by way of one or more struts  700 . In the exemplary embodiment shown in  FIGS. 7A and 7B , four struts  700  and five struts  700  are used, respectively, but any number of struts  700  may be used as desired for a particular application. Struts  700  may comprise any number of suitable materials as otherwise described herein, including, but not limited to, nitinol and stainless steel. Struts  700 , in an exemplary application, would have a pre-established “open” size and a pre-established “strength”, so that restraining device, in a native “rest” configuration, would be “open” (by way of, for example, the “memory” of struts  700 ) and would require some sort of pressure/force to open even further. The “open” configuration would keep first engaging component  12  and second engaging component  16  a fixed distance apart to avoid gastric tissue compression when positioned about a stomach. 
     An exemplary restraining device  10  may further comprise a mesh curtain  702  coupled to struts  700  as shown in  FIGS. 7A and 7B . Mesh curtain  702  may prevent or limit potential organ distension or remodeling when restraining device  10  is positioned about an organ of interest. A demi shaft  704 , as shown in  FIGS. 7A and 7B , may be positioned around at least part of struts  700  and/or mesh curtain  702  to facilitate insertion of restraining device  10  within a body. For example, and as shown in  FIG. 7A , restraining device  10  may be seen as inserted within a body, noting that restraining device is somewhat compressed by demi shaft  704 , to facilitate insertion through, for example, a laparoscopic port. After insertion, and as shown in  FIG. 7B , demi shaft  704  may be withdrawn in the direction of the arrow (shown as partially withdrawn in the figure) to allow restraining device  10  to obtain its original, uncompressed configuration, and ultimately removed from the body. Struts  702  may have a first configuration when positioned within demi shaft  704 , as shown in  FIG. 7A , and may have a second configuration when demi shaft  704  is removed, as shown on the left side of  FIG. 7B . 
     When restraining device  10  is in its native configuration, it may then be positioned about a stomach, for example, and the user positioning restraining device  10  may grasp stomach tissue using any number of laparoscopic tools through mesh aperture  706  as shown in  FIGS. 7B and 8 . As shown in  FIG. 8 , an exemplary restraining device  10  may also comprise one or more suture members  36  to allow one or more sutures (not shown) to be used to secure restraining device  10  to, for example, an anterior gastric wall. 
     An additional embodiment of a restraining device  10  of the disclosure of the present application is shown in  FIG. 9 . As shown in  FIG. 9 , restraining device  10  comprises a first engaging component  12  and a second engaging component  16 , whereby first engaging component  12  and second engaging component  16  are coupled to one another by way of one or more springs  22 . In this exemplary embodiment, restraining device  10  further comprises a mesh curtain  702  coupled to first engaging component  12  and second engaging component  16 , whereby mesh curtain  702  may prevent or reduce organ distension or remodeling when restraining device  10  is positioned about an organ. The flexibility/pliability of mesh curtain  702  would allow mesh curtain  702  to be closely positioned first engaging component  12  and second engaging component  16  upon insertion of restraining device  10  within a body, and may further allow mesh curtain  702  to expand in a direction of springs  22  as shown in  FIG. 9 , for example, to prevent organ distention. 
       FIG. 10  shows yet another embodiment of a restraining device  10  of the present application. As shown in  FIG. 10 , restraining device comprises a first engaging component  12  and a second engaging component  16 , whereby first engaging component  12  and second engaging component  16  are coupled to one another by way of one or more springs  22 . However, in this exemplary embodiment, restraining device  10  further comprises a pliable junction  1000  positioned within the first engaging component  12  and second engaging component  16 , effectively “splitting” each component, whereby each “split” component is connected to one another by way of a flexible structure  1002 . As shown in  FIG. 10 , flexible structure  1002  may comprise a PTFE band or a PTFE mesh, for example, whereby any potential embodiment of flexible structure  1002 , using one or more pliable materials disclosed herein or otherwise known in the art, allows the relatively or fully rigid first engaging component  12  and second engaging component  16  to better fit the stomach, allowing the patient, for example, to bend the stomach when restraining device  10  is positioned thereon. In addition, and as shown in the exemplary embodiment in  FIG. 10 , restraining device  10  may further comprise a tissue cover  1004  positioned either partially or fully around either or both of first engaging component  12  and second engaging component  16 . 
       FIG. 11  shows an exemplary embodiment of a restraining device  10  of the present application positioned within a laparoscopic port. As shown in  FIG. 11 , restraining device  10  is shown as being inserted into a body portion by way of laparoscopic port  1100 , with the exemplary laparoscopic port  1100  shown as comprising a ring  1102  and a port sleeve  1104  to facilitate introduction of restraining device  10  through an abdominal wall  1106 . Viewing the figure from the outside-in, restraining device  10  is shown as being introduced into an abdomen through abdominal wall  1106 , with peritoneum  1108  shown as being an innermost layer of the abdominal wall. 
     An additional embodiment of a restraining device  10  of the disclosure of the present application is shown in  FIG. 12A . As shown in  FIG. 12A , restraining device  10  comprises a first engaging component  12  and a second engaging component  16 , whereby first engaging component  12  and second engaging component  16  are coupled to one another by way of one or more couplers  1200 . In this exemplary embodiment, restraining device comprises two couplers  1200 , shown in further detail in  FIG. 12B . Couplers  1200  may comprise coupler arms  1202  connected to one another by way of a coupler bar  1204 , and may comprise any number of suitable materials as described herein for various components of the present disclosure. As shown in  FIG. 12A , coupler arms  1202  may be positioned within first engaging component  12  and second engaging component  16  by way of apertures  1210  (as shown in  FIG. 12B ) defined therein, allowing first engaging component  12  and second engaging component  16  to move relative to one another as couplers  1200  swivel when positioned at least partially within said apertures  1210 . 
     As shown in  FIG. 12B , an exemplary embodiment of a coupler  1200  may comprise a coupler protrusion  1206  at or near the end of each coupler arm  1202 , whereby coupler protrusions either prevent or restrict the removal of coupler  1200  from the either first engaging component  12  or the second engaging component  16  by way of stops  1208  positioned about the first engaging component  12  and the second engaging component  16  at or near the apertures  1210  defined therein. As coupler  1200  moves in the direction of the arrow shown in  FIG. 12B , coupler protrusions  1206  would engage stops  1208 , thus preventing or restricting the removal of coupler  1200  from the first engaging component  12  and/or the second engaging component  16 . 
     Insertion of the exemplary embodiment of the restraining device  10  shown in  FIG. 12A  into a body portion may be performed by inserting said restraining device  10  through a laparoscopic port with first engaging component  12  and second engaging component  16  either touching or nearly touching one another, and with couplers  1200  either mostly or fully inserted within apertures  1210  of restraining device  10 . When restraining device has been inserted into a body portion, first engaging component  12  and second engaging component  16  may be separated a pre-established distance from one another my way of turning/swiveling couplers  1200 . As such, couplers  1200 , as well as first engaging component  12  and second engaging component  16 , may be sized and shaped as desired for a particular application. 
       FIGS. 13A and 13B  show an exemplary embodiment of a restraining device  10  with a coupler  1200  positioned therein in a configuration to maximize the interior space  70  between first engaging component  12  and second engaging component  16 . As such, the configuration of coupler  1200  shown in  FIG. 12A  may be viewed as “closed,” while the configuration shown in  FIG. 13A  may be viewed as “open.” In addition, and as described above and shown in  FIG. 13A , coupler  1200  may be withdrawn from apertures of first engaging component  12  and second engaging component  16  to facilitate placement of restraining device about an organ of interest, Such withdrawal may be performed using any number of laparoscopic tools, for example, whereby coupler  1200  is withdrawn up to a point where protrusions  1206  would engage stops  1208  as shown in  FIG. 12B . 
     Another exemplary embodiment of a restraining device  10  of the disclosure of the present application is shown in  FIGS. 14A and 14B . As shown in  FIGS. 14A and 14B , restraining device  10  comprises a first engaging component  12  and a second engaging component  16 , whereby first engaging component  12  and second engaging component  16  are coupled to one another by way of one or more couplers  1200 . In the embodiments shown in  FIGS. 14A and 14B , couplers  1200  comprise “scissor” couplers  1200 , whereby at least two coupler bars  1204  are connected to one another via a pivot member  1400  so that coupler bars  1204  may pivot about one another at pivot member  1400 . As coupler  1200  shifts from a “closed” configuration, as shown in  FIG. 14A , to an “open” configuration, as shown in  FIG. 14B , coupler bars  1204  pivot about pivot member  1400  causing coupler bars  1204  to move closer to one another in a direction opposite the direction of the length of first engaging component  12  and second engaging component  16 . 
     Couplers  1200 , as shown in  FIGS. 14A and 14B , may “open” and “close” by way of movement of coupler arms  1202  (ends shown in the two figures) within apertures  1210  defined within first engaging component  12  and second engaging component  16 . Apertures  1210 , as shown in these exemplary embodiments, are configured as horizontal grooves to allow coupler arms  1202  to move closer to one another within the same aperture  1210  while coupler  1200  is “opening” and to allow coupler arms  1202  to move away from one another within the same aperture  1210  while coupler  1200  is “closing.” As shown in  FIG. 14B , restraining device  10 , in a fully open position, would maximize the interior space  70  between first engaging component  12  and second engaging component  16 . Protrusions  1402 , such as teeth, indentations, and the like, may be positioned at or near apertures  1210 , as shown in  FIG. 14B , to facilitate fixation of coupler arms  1202  in a desired position, allowing a user positioning restraining device  10  within a body to measure the exact the interior space  70  between first engaging component  12  and second engaging component  16 . 
     Upon insertion of the exemplary embodiment of restraining device  10  shown in  FIGS. 14A and 14B  within an abdominal cavity (through a laparoscopic port, for example), any number of laparoscopic tools may be used to grasp couplers  1200  to withdraw them from first engaging component  12  and second engaging component  16  as referenced herein regarding various other embodiments of restraining devices  10 . 
     An exemplary delivery apparatus for delivering a restraining device  10  of the present application is shown in  FIGS. 15A and 15B . As shown in  FIG. 15A , an exemplary delivery apparatus  1500  comprises a shaft  1502  and arms  1504  at or near a distal end  1506  of shaft  1502 . Apparatus  1500  may further comprise string  1508 , whereby string  1508  may either be coupled to or engaged by a pull bar  1510  (an exemplary “puller” of the present disclosure) positioned within the lumen of apparatus  1500 . Arms  1504  may engage an outer surface of first engaging component  12  and second engaging component  16 , a protrusion (not shown) extending from said components, or by way of a groove  1512  (shown in  FIG. 15B ) positioned within said components. 
     As shown in  FIG. 15A , string  1508  is coupled to springs  22  of restraining device  10 , whereby a “pulling” motion of pull bar may effectively pull springs  22  from a first configuration (not shown in  FIG. 15A ) to a second configuration as shown in  FIG. 15A  so that restraining device may be positioned about an organ of interest. In an additional embodiment, string  1508  may be positioned at least partially within the lumen of apparatus  1500 , whereby a user of apparatus may pull string  1508  instead of pulling pull bar  1510  to operate apparatus  1500 . Various components of apparatus  1500  may comprise any number of suitable materials, including, but not limited to, the various materials referenced herein in connection with components of restraining device  10 . For example, string  1508  may comprise, for example, plastic or metal thread. 
     For example, and in an abdominal cavity with the epiplon lesser curvature dissected, arms  1504  of apparatus  1500  may position restraining device  10  to a desired location, springs  22  of restraining device  10  may be widely opened, thus separating the first engaging component  12  and the second engaging component  16  by using pull bar  1510  to pull the strings  1508  and move springs  22  from an axial position to a 90° position relative to first engaging component  12  and the second engaging component. An “opened” restraining device  10  may then be introduced through the dissected lesser curvature space in parallel position to the intragastric mannequin tube, thus creating a desired pouch size. First engaging component  12  and second engaging component  16 , upon positioning restraining device  10  about a stomach, would occupy the anterior and posterior wall of the stomach. When the first engaging component  12  and the second engaging component  16  are located in the desired position, spring  22  approximates the first engaging component  12  and the second engaging component  16  to each other gradually without producing any ischemic or tissue damage. Upon moving springs  22  to their desired location and/or positioning restraining device  10  about the stomach, restraining device  10  is separated from apparatus  1500 , strings  1508  are cut and apparatus  1500  is pulled out of the abdominal cavity through the port. Restraining device  10  may then be secured in the gastric tissue with superficial stitches. 
       FIG. 15B  shows an exemplary embodiment of at least a portion of apparatus  1500  engaging a “closed” restraining device  10 . As shown in  FIG. 15B , arms  1504  of apparatus  1500  are shown engaging first engaging component  12  and second engaging component  16  of restraining device  10  by way of grooves  1512  positioned within said components, permitting apparatus  1500  to deliver restraining device  10  through an abdominal port. 
       FIGS. 16A and 16B  show an exemplary embodiment of an apparatus  1500  engaging/positioning an exemplary restraining device  10  of the disclosure of the present application. As shown in  FIGS. 16A and 16B , arms  1504  of apparatus  1500  may engage the first engaging component  12  and the second engaging component  16  of restraining device  10 , whereby the “opening” of arms  1504  would facilitate the “opening” of restraining device from a “closed” configuration (as shown in  FIG. 16A ) to an “open” configuration (as shown in  FIG. 16B ). 
     “Opening” restraining device  10 , as shown in  FIG. 16B , may be performed as follows. In the abdominal cavity with the epiplon lesser curvature dissected, the arms  1504  of apparatus  1500  may be widely opened, thus separating the first engaging component  12  and the second engaging component  16  of restraining device  10 . A surgeon, for example and with the aid of laparoscopic graspers, may then “pull” out couplers  1200 , placing couplers  1200  in a withdrawn configuration as shown in  FIG. 16B . Restraining device  10 , in an “open” configuration, may be introduced through the dissected lesser curvature space in parallel position to the intragastric mannequin tube, thus creating the desired stomach pouch size. First engaging component  12  and second engaging component  16 , when positioned about a stomach, would occupy the anterior and posterior wall of the stomach. When the first engaging component  12  and the second engaging component  16  are located in the desired position, the user/operator may then approximate the plates to each other gradually (millimetrically) using apparatus  1500  device without producing any ischemic or tissue damage. When the user/operator has positioned restraining device  10 , apparatus  1500  would then be separated from restraining device and pulled out of the abdominal cavity through the port. If desired, restraining device may also be secured in the gastric tissue with superficial stitches. 
       FIGS. 17A and 17B  show another exemplary embodiment of an apparatus  1500  engaging/positioning an exemplary restraining device  10  of the disclosure of the present application. As shown in  FIGS. 17A and 17B , arms  1504  of apparatus  1500  may engage the first engaging component  12  and the second engaging component  16  of restraining device  10 , whereby the use of string  1508  connected to the first engaging component  12  and the second engaging component  16  may be used by an operator of apparatus  1500  to “open” and/or “close” said components. One or more strings  1508 , in such exemplary embodiments, may be coupled at their first ends to the first engaging component  12  and/or the second engaging component  16 , and may be coupled at their second ends to a string rotator  1700  (another exemplary “puller” of the present disclosure) as shown in  FIGS. 17A and 17B . Operation/rotation of string rotator  1700  may then facilitate the “opening” of restraining device  10  from a “closed” configuration (as shown in  FIG. 17A ) to an “open” configuration (as shown in  FIG. 17B ). In such an embodiment, arms  1504  may also be positioned upon the first engaging component  12  and/or the second engaging component  16  at or near the center of said components (forming a “pivot” area), and the string rotator  1700  and strings  1504  affixed thereto may operate to keep said components in their axial position. Ultimate restraining device  10  delivery may be performed using one or more methods described herein. 
     Restraining device  10  may also be positioned “perpendicularly” using apparatus  1500  as shown in  FIG. 18 . As shown in  FIG. 18 , arms  1504  and strings  1508  are shown positioned about the first engaging component  12  and the second engaging component  16  “perpendicularly” so that restraining device  10  and apparatus  1500  are not aligned with one another. Rotation of string rotator  1700 , as described above, may facilitate the opening and/or closing of restraining device  10 . 
     The various embodiments of restraining devices  10  of the present disclosure may be introduced into a body cavity through, for example, a laparoscopic port. Such restraining devices  10  would be inserted while “compressed” (as shown in  FIGS. 1 ,  7 A,  10 ,  11 ,  12 A, and  14 A, for example), and when inserted, would be “opened” or “deployed” (as shown in  FIGS. 2 ,  7 B,  8 ,  9 ,  13 A,  13 B, and  14 B, for example) prior to being positioned about a stomach  100 . In addition, a user of such a restraining device  10  may adjust the opening/deployed dimensions of restraining device  10  prior to positioning it about a stomach, and may further tailor the open/deployed dimensions of restraining device  10  after it has been positioned as desired. 
     Furthermore, any number of exemplary embodiments of restraining devices  10  of the present application may be wholly or partially resorbable by the body. For example, and using the exemplary restraining device  10  shown in  FIGS. 1 and 2  as an example, first and second engaging components  12 ,  16  may not be resorbable by the body, while springs  22  may be resorbable. In such an embodiment, restraining device  10 , once positioned about a stomach  100 , may slowly begin the process of total or partial resorption. Resorbable materials suitable for one or more portions of restraining devices  10  may include, but are not limited to, polyglycolide (PGA), polylactide (PLA), 1-lactide (LPLA), poly(dl-lactide) (DLPLA), poly(ε-caprolactone) (PCL), poly(dioxanone) (PDO), polylglycolide-trimethylene carbonate (PGA-TMC), poly(d,l-lactide-co-glycolide) (DLPLG), or combinations thereof. 
     In a situation where it is desired to have restraining device  10  serve as a reversible bariatric device, and if it is desired not to engage in a subsequent procedure to, for example, laparoscopically remove some or all of restraining device  10  from a body, some or all of restraining device  10  may be resorbed. By way of example, an exemplary restraining device comprising resorbable springs  22  may be positioned about a stomach, and first and second engaging components  12 ,  16  may slowly become coated with various fibrotic tissue. As springs  22  resorb, springs  22  will eventually no longer operate to connect first and second engaging components  12 ,  16  to one another, which will effectively cause the various portions of restraining device  10  to no longer serve as a restraining mechanism. Springs  22  may also become coated, in part or in their entirety, by fibrotic tissue, so that when springs  22  resorb, first and second engaging components  12 ,  16  remain positioned about stomach  100 , but the introduction of food into a stomach  100 , for example, does not exert any pressure on springs  22  by way of first and second engaging components  12 ,  16  as first and second engaging components  12 ,  16  are no longer connected to one another by way of springs  22 . Furthermore, first and second engaging components  12 ,  16  may be resorbable and springs  22  may not, so as first and second engaging components  12 ,  16  resorb within the body, springs  22  no longer serve to connect first and second engaging components  12 ,  16  to each other, and restraining device  10  no longer performs any restraining function. Additional embodiments of restraining devices  10  may be resorbable, including, but not limited to, struts  700  and mesh curtain  702 . 
     Regarding removal of exemplary embodiments of restraining devices  10  of the present application, said restraining devices  10  may be removed in whole or in part, for example, by way of a laparoscopic procedure. Reversibility of restraining devices  10 , as referenced in the present application, pertains to the ability to position a restraining device  10  about a tissue or organ, and at some time thereafter, have some or all of restraining device  10  resorb within a body or remove some or all of restraining device from the body so that restraining device  10  no longer functions to restrain a tissue or organ. For example, and referencing the exemplary embodiments shown in  FIGS. 1 and 2 , a laparoscopic procedure to remove springs  22  from the restraining device  10  and the body, but not to remove first and second engaging components  12 ,  16  from the body, would have the effect of “reversing” the procedure of placing said restraining device  10  about a tissue or organ. Similarly, and as shown in  FIGS. 7A ,  7 B, and  8 , removal of struts  700  from restraining device  10  would also have the effect of “reversing” the placement of restraining device  10  about a tissue or organ. 
     Furthermore, and if desired, the entirety of restraining device  10  may be removed laparoscopically by, for example, reversing the steps used to insert said restraining device  10  within a body. For example, a method  1900  for removing a restraining device  10  from a body as shown in  FIG. 19  may comprise the steps of withdrawing restraining device  10  from a tissue or organ (withdrawal step  1904 ), configuring restraining device  10  to fit within a laparoscopic port (configuration step  1906 ), and removing restraining device  10  from the body through a laparoscopic port (removal step  1908 ). Such an exemplary method may be preceded by positioning a laparoscopic port within a body to facilitate removal of restraining device  10  (port insertion step  1902 ), and may be followed by removing said laparoscopic port from the body after removal step  1908  (port removal step  1910 ). 
     Additional embodiments of restraining devices  10  of the present disclosure are shown in  FIGS. 20 and 23 . As shown in the embodiments shown in  FIGS. 20 and 23 , restraining devices  10  comprise a first engaging component  12  and a second engaging component  16 , such as those provided in various other embodiments herein. First engaging component  12  and second engaging component  16 , in such an exemplary embodiment, are positioned relatively parallel to one another. A first swivel arm  2000  and a second swivel arm  2002  are pivotally connected to first engaging component  12  and second engaging component  16 , so that first swivel arm  2000  engages first engaging component  12  at pivot point  2004  and engages second engaging component  16  at pivot point  2006 , and so that second swivel arm  2002  engages first engaging component  12  at pivot point  2008  and engages second engaging component  16  at pivot point  2010 . First swivel arm  2000  and second swivel arm  2002  may swivel in the directions shown in arrows A and B in  FIGS. 20 and 23 , noting that first swivel arm  2000  and second swivel arm  2002  may move in opposite directions, so that one moves in the direction of arrow A and the other moves in the direction of arrow B, or first swivel arm  2000  and second swivel arm  2002  may move in the same direction. 
     First engaging component  12  and/or second engaging component  16  may present studs  2012 , as shown in  FIGS. 20 and 23 , whereby studs  2012  permit first swivel arm  2000  and/or second swivel arm  2002  to be engaged thereto and permit swiveling/rotation about the various pivot points. In at least one embodiment, studs  2012  have a bulbous component relatively larger than a non-bulbous portion, so that a first swivel arm  2000  and/or a second swivel arm  2002  presenting one or more apertures  2014  therethrough may engage studs  2012 . Any number of other means to couple first swivel arm  2000  and/or second swivel arm  2002  to first engaging component  12  and/or second engaging component  16  may be used, such as pins, rivets, snaps, screws, and/or other fasteners or coupling means. 
     First swivel arm  2000  and second swivel arm  2002 , as shown in  FIGS. 20 and 23 , may further comprise a first interconnection arm  2016  and a second interconnection arm  2018  positioned relative to bends  2020 ,  2022  of said arms. Bends  2020 ,  2022 , as shown in  FIGS. 20 and 23 , are positioned in the relative middle (somewhere between the relative ends) of first swivel arm  2000  and a second swivel arm  2002 , so that first swivel arm  2000  and second swivel arm  2002  form a relative “U-shape” within restraining device  10 . First swivel arm  2000  and/or a second swivel arm  2002  may further comprise various additional curvatures  2024 , such as shown in  FIG. 20 , such that bends  2020 ,  2022  and/or curvatures  2024  define a native U-shaped configuration as previously described. 
     An interior space  70  between the first engaging component  12  and the second engaging components  16 , as shown in  FIGS. 20 and 23 , may change depending on various factors and/or configurations of restraining device  10 . For example, and during insertion of an embodiment of a restraining device  10  such as shown in  FIG. 20  or  23  through a laparoscopic port, first swivel arm  2000  and a second swivel arm  2002  may be relatively parallel to, or in the same relative plane as, first engaging component  12  and second engaging component  16 , so that the interior space  70  is relatively small. After insertion, and after swiveling first swivel arm  2000  and a second swivel arm  2002  about first engaging component  12  and second engaging components  16 , the interior space  70  may either stay the same or increase to facilitate placement of restraining device  10  about a stomach, for example. Furthermore, the use of a tape  2026  positioned about one or more of the first swivel arm  2000  and the second swivel arm  2002 , as shown in  FIG. 20 , may further adjust the amount of interior space  70  between the first engaging component  12  and the second engaging components  16  depending on the amount of relative tension (pull) is applied to tape  2026 . For example, if tape  2026  is positioned about one or more of the first swivel arm  2000 , and the second swivel arm  2002  so that pulling tape  2026  in a direction shown by arrow C in  FIG. 20  causes portions of tape  2026  to press against first interconnection arm  2016  and/or second interconnection arm  2018  causing the relative ends of each of first swivel arm  2000  and a second swivel arm  2002  to move toward each other, the amount of interior space  70  between first engaging component  12  and second engaging component  16  may be reduced. In such an embodiment, restraining device  10  could be inserted into a mammalian body, positioned around a bodily organ without applying pressure to said organ, and tape  2026  could be pulled so that the amount of interior space  70  is adjusted as desired for the particular application. In a bariatric application, for example, it is desired not to have portions of restrictive device  10  apply any pressure about the stomach, but tape  2026  could be pulled/adjusted so first engaging component  12  and second engaging component  16  properly engage the stomach and be sutured thereto as desired. Distention of the stomach, such as by the introduction of solid and/or liquid food or water into the stomach, would cause the stomach to exert a force/pressure against the first engaging component  12  and second engaging component  16 , forming a first stomach portion  110  and a second stomach portion  112  as shown in  FIGS. 4A and 4B  referenced above and  FIG. 21  referenced below. 
     In addition, and as shown in the exemplary embodiments of restraining devices  10  of the present disclosure shown in  FIGS. 20 and 23 , various portions of restraining device  10 , such as the first engaging component  12 , the second engaging component  16 , the first swivel arm  2000 , and/or the second swivel arm  2002  may have one or more suture apertures  32  defined therethrough to facilitate the placement of one or more sutures  34  (also referred to herein as strings  34 ) to couple restraining device  10  to a portion of a mammalian body, such as a stomach. In various embodiments, one or more of the relative ends of the first engaging component  12  and the second engaging component  16  may be rounded and/or tapered to improve overall patient comfort when a restraining device is positioned within the patient&#39;s body. 
       FIG. 21  shows an exemplary embodiment of a restraining device  10 , such as shown in  FIG. 20 , positioned about a stomach. As shown in  FIG. 21 , device  10  may be positioned about stomach  100  similar to placement of restraining device  10  about stomach  100  as shown in  FIG. 5B , so that the first engaging component  12  and the second engaging component  16  (not shown in  FIG. 21 ) may engage opposite sides of stomach  100 . Restraining device  10  may be secured to stomach  100  using one or more sutures  34  to couple restraining device  10  to stomach  100 , and restraining device  100  may be further positioned about stomach  100  by way of adjusting tape  2026  positioned around restraining device  10 . As shown in  FIG. 21 , tape  2026  is positioned about restraining device  10  so to engage first interconnection arm  2016  and second interconnection arm  2018 , whereby pulling tape  2026  in a direction shown by arrow C would cause first engaging component  12  and second engaging component  16  to move closer to one another. Tape  2026  may have one or more detectable portions  2100  positioned/imprinted thereon, so that a user of restraining device  10  can “see” the adjustment of tape  2026  by way of fluoroscopy (if detectable portions  2100  are radioopaque), camera, or other means whereby portions of a device positioned within a body can be visualized, either directly or through some sort of technological means, to allow a user of such a device to adjust the same. 
     Furthermore, and as shown in  FIG. 21 , restraining device  10  may have a cover flap  2012  positioned thereon to assist maintaining the placement of restraining device  10  about stomach  100 . Cover flap  2012 , as shown in  FIG. 21 , may be ultimately coupled to first engaging component  12  and second engaging component  16  (not shown in  FIG. 21 ), so that after restraining device  10  is positioned about a stomach  100 , cover flap  2012  may be closed (initially secured to first engaging component  12  and closed by way of securing cover flap  2012  to second engaging component  16 , or vice versa) about an upper portion of stomach  100 . 
     As referenced above, restraining device  10  is positioned about stomach  100  so not to exert pressure upon stomach  100 , but when stomach  100  becomes distended, stomach  100  exerts pressure/force upon first engaging component  12  and second engaging component  16  of restraining device  10 . 
     Steps of a method for delivering and positioning an embodiment of a restraining device  10 , such as the embodiment shown in  FIGS. 20 and 21 , are shown in  FIG. 22 . As shown in  FIG. 22 , exemplary method  2200  comprises the step of laparascopically inserting/advancing restraining device  10  into a patient&#39;s body (an exemplary insertion step  2202 ). In at least one embodiment, the restraining device  10  may be inserted through a  15  millimeter cannula under insufflation into the appropriate cavity of the patient&#39;s body. This may be achieved through use of an exemplary delivery device known in the art. At step  2202 , first swivel arm  2000  and second swivel arm  2002  of restraining device  10  are swiveled/positioned in the substantially parallel position such that the overall diameter of the restraining device  10  is sufficiently narrow for insertion into the body. 
     At step  2204 , restraining device  10  is advanced to a location adjacent to a targeted tissue, such as a stomach  100  (an exemplary advancement step  2204 ). At step  2206  (an exemplary swivel step), first swivel arm  2000  and second swivel arm  2002  of restraining device  10  are swiveled from a substantially parallel position to a substantially perpendicular position, separating the first and second engaging components  12 ,  16  from one another to a native interior space  70 . Step  2206  may be performed using any number of standard laparoscopic tools known in the art useful to pull and grasp portions of a tissue or a device. In this manner, neither the proximal ends  13 ,  17  nor distal ends  14 ,  18  of the first and second engaging components  12 ,  16  of restraining device  10  are blocked by first swivel arm  2000  and second swivel arm  2002 , and the first and second engaging components  12 ,  16  may be advanced over a targeted tissue, such as a stomach  100 . 
     At step  2208 , and under fluoroscopy, direct camera control or otherwise, restraining device  10  is positioned over the targeted tissue (an exemplary positioning step). In at least one embodiment, and at step  2206 , the first side  12 A of the first engaging component  12  is positioned adjacent to the desired surface of the targeted tissue and the first side  16 A of the second engaging component  16  is positioned adjacent to an opposite side of the targeted tissue. As the first and second engaging components  12 ,  16  of the restraining device  10  are positioned adjacent to opposite sides of the targeted tissue, at this step  2208  the targeted tissue is positioned within the interior space  70  formed between the first and second engaging components  12 ,  16 . Further, due to the configuration and composition of restraining device  10 , restraining device  10  can remain within the patient&#39;s body for as long as the restoration or support treatment delivered thereby is desired. 
     After restraining device  10  is positioned about a targeted tissue (by way of performing positioning step  2208 ), method  2200  may further comprise the optional steps of securing one or more sutures to connect restraining device  10  to the targeted tissue (an exemplary suturing step  2210 ), and may further comprise the step of securing cover flap  2012  to further secure restraining device about the targeted tissue (an exemplary cover flap step  2212 ). In addition, and as shown in  FIG. 22 , method  2200  may further comprise the step of adjusting tape  2026  to control/adjust the interior space  70  between the first engaging component  12  and the second engaging component  16  whereby at least a portion of the targeted tissue is positioned therebetween (an exemplary tape adjustment step  2214 ). 
     In the exemplary embodiment of a restraining device  10 , as shown in  FIG. 23 , restraining device  10  comprises one or more adjustment rods  2300  coupled to the first swivel arm  2000  and the second swivel arm  2002 . In the embodiment shown in  FIG. 23 , for example, adjustment rods  2300  are coupled to first swivel arm  2000  and second swivel arm  2002  at or near bends  2020 ,  2022 , and are further coupled to a first interconnection arm  2016  and a second interconnection arm  2018 , respectively. As shown in  FIG. 23 , at in at least one embodiment, adjustment rods  2300  are coupled to first swivel arm  2000  and second swivel arm  2002  through swivel arm apertures  2302  defined therethrough, and are further coupled to first interconnection arm  2016  and second interconnection arm  2018  through interconnection arm apertures  2304  defined therethrough. 
     Adjustment rods  2300 , as shown in  FIGS. 23 and 25 , further comprise a bar  2306  coupled to adjustment rods  2300  at or near a distal end  2308  of adjustment rod  2300 . Bar  2306 , as shown in  FIG. 24 , is positioned distal to first interconnection arm  2016 /second interconnection arm  2018 , so that adjustment of a dial  2310  coupled to adjustment rod  2300  causes movement of first engaging component  12  and second engaging component  16  toward or away from one another. As shown in  FIG. 24 , first interconnection arm  2016  and second interconnection arm  2018 , in various embodiments, may extend either completely or substantially along the length of first swivel arm  2000  and second swivel arm  2002  distal to first interconnection arm  2016  and second interconnection arm  2018 , so that adjustment of dial  2310  facilitates movement of first swivel arm  2000  and second swivel arm  2002 , thus facilitating movement of first engaging component  12  and second engaging component  16 . 
     As shown in  FIGS. 23-25 , adjustment rod  2300  may further comprise a cap  2312  coupled thereto at or near a proximal end  2314  of adjustment rod  2300 . Cap  2312 , as shown in  FIGS. 23-25 , may prevent dial  2310  from disengaging adjustment rod  2300  so that when restraining device  10  is positioned within a body, dial  2310  remains upon restraining device  10 . Cap  2312 , in at least one embodiment, may be bulbous/rounded at one end for comfort when restraining device  10  is positioned within a body. 
     As shown in  FIG. 24 , dial  2310  may facilitate adjustment of device  10  by way of threads  2316  positioned along adjustment rod  2300 . In such an embodiment, rotation of dial  2310  in a first direction would cause first engaging component  12  and second engaging component  16  to move toward one another, and rotation of dial  2310  in a second/opposite direction would cause first engaging component  12  and second engaging component  16  to move away from one another. As such, restraining device  10  may be positioned within a body about a stomach, for example, and be adjusted using dial  2310  so that restraining device  10  is optimally positioned about the stomach. 
     As shown in the exemplary embodiments in  FIGS. 25 and 26 , dial  2310  may define a dial aperture  2318 , whereby indicia  2320  upon adjustment rod  2300  may be viewed therethrough. As shown in  FIG. 26 , for example, as dial  2310  is rotated, one or more indicia  2320  may be visible through dial aperture  2318 , so that a user of such an embodiment of a restraining device  10  of the present disclosure may identify a level of adjustment. Indicia  2320  may be one or more numbers, letters, lines and/or other indicia  2320  useful to identify a level of adjustment of restraining device  10 . 
     As shown in  FIG. 27 , and in at least one embodiment of a restraining device  10  of the present disclosure, restraining device  10  further comprises at least one flange  2700  coupled to first swivel arm  2000  and/or second swivel arm  2002 . Flange  2700  defines an aperture therethrough so that adjustment rod  2300  may fit therethrough, providing physical support for dial  2310  as dial  2310  engages said flange  2700 . 
     An exemplary embodiment of a restraining device  10  of the present disclosure having adjustment rods  2300  is shown in  FIG. 28 . As shown in  FIG. 28 , first engaging component  12  and/or second engaging component  16  may define one or more facets  2800  along at least part of the length of said components  12 ,  16 , whereby facets  2800  provide a generally arcuate profile as shown therein. Facets  2800  may further improve the overall comfort of restraining device  10  when it is positioned with a patient&#39;s body. 
     Steps of a method for delivering and positioning an embodiment of a restraining device  10 , such as the embodiment shown in  FIG. 23 , are shown in  FIG. 29 . As shown in  FIG. 29 , exemplary method  2900  comprises the step of laparascopically inserting/advancing restraining device  10  into a patient&#39;s body (an exemplary insertion step  2202 ) as previously discussed herein. At step  2202 , first swivel arm  2000  and second swivel arm  2002  of restraining device  10  are swiveled/positioned in the substantially parallel position such that the overall diameter of the restraining device  10  is sufficiently narrow for insertion into the body. 
     At step  2204 , restraining device  10  is advanced to a location adjacent to a targeted tissue, such as a stomach  100  (an exemplary advancement step  2204 ). At step  2206  (an exemplary swivel step), first swivel arm  2000  and second swivel arm  2002  of restraining device  10  are swiveled from a substantially parallel position to a substantially perpendicular position, separating the first and second engaging components  12 ,  16  from one another to a native interior space  70  as previously discussed herein. 
     At step  2208 , and under fluoroscopy, direct camera control or otherwise, restraining device  10  is positioned over the targeted tissue (an exemplary positioning step) as previously referenced herein. After restraining device  10  is positioned about a targeted tissue (by way of performing positioning step  2208 ), method  2900  may further comprise the optional steps of securing one or more sutures to connect restraining device  10  to the targeted tissue (an exemplary suturing step  2210 ), and regarding an embodiment of restraining device  10  of the present disclosure comprising a cover flap  2012 , method  2900  may further comprise the step of securing cover flap  2012  to further secure restraining device about the targeted tissue (an exemplary cover flap step  2212 ). In addition, and as shown in  FIG. 29 , method  2900  may further comprise the optional step of rotating dial  2310  to control/adjust the interior space  70  between the first engaging component  12  and the second engaging component  16  whereby at least a portion of the targeted tissue is positioned therebetween (an exemplary dial adjustment step  2902 ). 
     An additional embodiment of a restraining device  10  of the present disclosure is shown in  FIGS. 30 and 31 . As shown in  FIGS. 30 and 31 , restraining devices  10  each comprise a first engaging component  12  and a second engaging component  16 , such as those provided in various other embodiments herein. First engaging component  12  and second engaging component  16 , in such exemplary embodiments, are positioned relatively parallel to one another. A first swivel arm  2000  and a second swivel arm  2002  are pivotally connected to first engaging component  12  and second engaging component  16 , so that first swivel arm  2000  engages first engaging component  12  at pivot point  2004  and engages second engaging component  16  at pivot point  2006 , and so that second swivel arm  2002  engages first engaging component  12  at pivot point  2008  and engages second engaging component  16  at pivot point  2010 . First swivel arm  2000  and second swivel arm  2002  may swivel in the directions shown in arrows A and B in  FIGS. 30 and 31 , noting that first swivel arm  2000  and second swivel arm  2002  may move in opposite directions, so that one moves in the direction of arrow A and the other moves in the direction of arrow B. 
     As shown in  FIGS. 30 and 31 , first swivel arm  2000  may comprise a first arm member  3000  and a second arm member  3002 , and second swivel arm  2002  may comprise a first arm member  3020  and a second arm member  3022 . First arm members  3000 ,  3020  and second arm members  3002 ,  3022  may each couple to a hub  3004 ,  3024  as shown in  FIGS. 30 and 31 . In at least one embodiment, and as shown in  FIGS. 30 and 31 , second arm members  3002 ,  3022  may be fixedly coupled to hubs  3004 ,  3024 , and first arm members  3000 ,  3020  may slidingly engage said hubs  3004 ,  3024 , whereby portions of first arm members  3000 ,  3020  are positioned between hubs  3004 ,  3024  and hub brackets  3006 ,  3026 . First arm members  3000 ,  3020  may each have at least one bend  3008 ,  3028  therein, as shown in  FIGS. 30 and 31 , to facilitate said engagement of first arm members  3000 ,  3020  to hubs  3004 ,  3024 . First arm members  3000 ,  3020 , in at least one embodiment, are capable of movement relative to hubs  3004 ,  3024  in the directions shown in arrows C and D in  FIGS. 30 and 31 , whereby first arm members  3000 ,  3020  move in a first direction until they contact hubs  3004 ,  3024 , for example, and move in a second direction until arm flanges  3010 ,  3030  of first arm members  3000 ,  3020  contact hub brackets  3006 ,  3026 , for example. First arm members  3000 ,  3020  and second arm members  3002 ,  3022  may be referred to as “fixed arms” if they are fixed to one of hubs  3004 ,  3024 , and may be referred to as “expandable arms” if they are coupled to hubs  3004 ,  3024  by way of hub brackets  3006 ,  3026  to facilitate movement relative thereto. 
     In at least one embodiment of an exemplary restraining device  10  of the present disclosure, and as shown in  FIGS. 30 and 31 , hub brackets  3006 ,  3026  may be coupled to hubs  3004 ,  3024  by way of one or more fasteners  3012 , such as one or more screws, pins, rivets, and the like. Similarly, second arm members  3002 ,  3022  may be coupled to hubs  3004 ,  3024  by way of one or more fasteners  3012 . In at least one embodiment, first arm members  3000 ,  3020  and/or second arm members  3002 ,  3022  are comprised of stainless steel (such as 316LVM, or implant-grade stainless steel) hubs  3004 ,  3024  are comprised of one or more polyaryletherketones (PEEKs), and hub brackets  3006 ,  3026  are also comprised of stainless steel. First engaging component  12  and second engaging component  16  may, in at least one embodiment, comprise stainless steel which may then be coated/overmolded with a biocompatible polymer, such as polyurethane (PX205, for example) or tecothane (TT-1075D-M, for example). 
     In various embodiments of restraining devices  10  of the present disclosure, restraining devices  10  may comprise one or more pads  3014 ,  3034  coupled to first arm members  3000 ,  3020  and/or second arm members  3002 ,  3022 . Said pads  3014 ,  3034  may comprise any number of biocompatible polymers and/or other materials that are suitable for contacting an organ, such as a stomach, and which may provide some sort of cushioning effect. In at least one embodiment, pads  3014 ,  3034  may be comprised of a biocompatible polymer such as carbothane (such as PC-3595A), for example, and may be coupled to first arm members  3000 ,  3020  and/or second arm members  3002 ,  3022  using one or more fasteners  3012 . In at least one embodiment, fasteners  3012 , as referenced herein, may be comprised of stainless steel. 
     Regarding the exemplary embodiment of restraining device  10  shown in  FIGS. 30 and 31 , restraining device is shown in an open configuration in  FIG. 30  and in a closed configuration in  FIG. 31 . As shown in  FIG. 31 , an exemplary restraining device  10  of the present disclosure may comprise a strap  3100  coupled thereto at first engaging component  12  and second engaging component  16 . In at least one embodiment, strap  3100  is fixedly coupled to one or both of first engaging component  12  and second engaging component  16 , and in another embodiment, strap is removably coupled to one or both of first engaging component  12  and second engaging component  16  by way of one or more sutures  32  (such as a 2-0 silk suture, for example), as shown in  FIG. 31 . As shown in the embodiment of restraining device  10  in  FIG. 31 , a first end  3102  of strap  3100  is fixedly coupled to second engaging component  16 , and a second end  3104  of strap  3100  is removably coupled to first engaging component  12  by way of suture  32 . In practice, suture  32  may not be positioned within suture aperture(s)  34  defined within one or more components of restraining device  10  until after restraining device  10  has been inserted into a mammalian body. In at least one embodiment, one or more suture apertures  34  defined within one or more components of restraining device  10  may comprise/define one or more eyelets  3106 , whereby said eyelets  3106  provide additional reinforcement/strength, and may also provide a more smooth, rounded contour than suture apertures  34  so not to cause unintended wear, and potential breakage, of one or more sutures  32  positioned therethrough. In at least one embodiment, strap  3100  comprises carbothane (PC-3595A), and eyelets  3106  are comprised of nickel. In at least another embodiment, strap  3100 , or portions thereof, may be radiopaque. 
       FIGS. 32 and 33  show top views of exemplary restraining devices  10  of the present disclosure. As shown in  FIG. 32 , restraining device  10  is shown with first swivel arm  2000  and second swivel arm  2002  in a positioned whereby said arms  2000 ,  2002  are at least substantially perpendicular to first engaging component  12 . As shown in  FIG. 32 , and in at least one embodiment of a restraining device  10  of the present disclosure, first swivel arm  2000  is relatively shorter than second swivel arm  2002 , whereby such a configuration allows for placement of restraining device  10  about a stomach, for example, as shown in  FIGS. 40 ,  41 , and  42 . 
       FIG. 33  shows an exemplary restraining device  10  whereby first swivel arm  2000  and second swivel arm  2002  share a common linear axis with first engaging component  12 . In the configuration shown in  FIG. 33 , for example, restraining device  10  may fit within a bodily laparoscopic port for eventual swiveling of arms  2000 ,  2002  and placement of restraining device  10  about an organ.  FIG. 34  shows a front view of an exemplary restraining device  10  of the present disclosure in a similar configuration as shown in  FIG. 33 , and  FIG. 35  shows a perspective view of restraining device  10  in the same configuration. 
       FIGS. 36 and 37  show a side view and a perspective view, respectively, of an exemplary first swivel arm  2000  of the present disclosure. In at least one embodiment, and as shown in  FIG. 36 , first swivel arm  2000  has an interior length (as indicated by arrow A in the figure) of about 26.5 mm, and has an expanded interior height (as indicated by arrow B in the figure) of about 19.1 mm. In other embodiments, the interior length and interior height may be greater or lesser than those shown in the figure. 
     As shown in  FIGS. 36 and 37 , an exemplary first swivel arm  2000  may have one or more distal arm flanges  3600 , which, in at least one embodiment, are bent relatively down/up and then out, as shown in the figures, so that exemplary first swivel arm  2000  may engage first engaging component  12  and second engaging component  16  while maintaining integrity of first swivel arm  2000  and/or providing additional clearance for an organ positioned therebetween. In at least one embodiment, and as shown in  FIG. 36 , distal arm flanges  3600  result in an expanded flange height (as indicated by arrow C in the figure) of less than the expanded interior height. The relative distal ends of first swivel arm  2000 , which may themselves comprise distal arm flanges  3600 , may comprise one or more arm apertures  3602  configured to receive, for example, one or more rivets  3604  (as shown in  FIGS. 30 and 31 ) therethrough to couple first swivel arm  2000  to a first engaging component  12  and a second engaging component  16 . In at least one embodiment, rivets  3604  are comprised of stainless steel. In at least another embodiment, another type of fastener  3012 , as described herein, aside from a rivet  3604  may be used. 
       FIGS. 38 and 39  show a side view and a perspective view, respectively, of an exemplary second swivel arm  2002  of the present disclosure. In at least one embodiment, and as shown in  FIG. 38 , second swivel arm  2002  has an interior length (as indicated by arrow A in the figure) of about 37 mm, and has an expanded interior height (as indicated by arrow B in the figure) of about 18 mm. In other embodiments, the interior length and interior height may be greater or lesser than those shown in the figure. 
     As shown in  FIGS. 38 and 39 , an exemplary second swivel arm  2002  may also have one or more distal arm flanges  3600 , which, in at least one embodiment, are bent relatively down/up and then out, as shown in the figures, so that exemplary second swivel arm  2002  may engage first engaging component  12  and second engaging component  16  while maintaining integrity of second swivel arm  2002  and/or providing additional clearance for an organ positioned therebetween. In at least one embodiment, and as shown in  FIG. 38 , distal arm flanges  3600  result in an expanded flange height (as indicated by arrow C in the figure) of less than the expanded interior height. The relative distal ends of second swivel arm  2002 , which may themselves comprise distal arm flanges  3600 , may comprise one or more arm apertures  3602  configured to receive, for example, one or more rivets  3604  (as shown in  FIGS. 30 and 31 ) therethrough to couple second swivel arm  2002  to a first engaging component  12  and a second engaging component  16 . 
       FIG. 40  shows an exemplary embodiment of a restraining device  10 , such as shown in  FIGS. 30 and 31 , positioned about a stomach. As shown in  FIG. 40 , device  10  may be positioned about stomach  100  similar to placement of restraining device  10  about stomach  100  as shown in  FIGS. 5B and 21 , for example, so that the first engaging component  12  (not shown in  FIG. 40 ) and the second engaging component  16  may engage opposite sides of stomach  100 . Restraining device  10  may be secured to stomach  100  using one or more sutures  34  to couple restraining device  10  to stomach  100 , or one or more sutures  34  may be positioned within suture aperture(s)  34  within strap  3100  and one or both of first engaging first engaging component  12  and second engaging component  16  to secure restraining device  100  about a stomach  100 .  FIGS. 41 and 42  show additional views of an exemplary restraining device  10  positioned about a stomach  100 . 
     The various embodiments of restraining devices  10  described herein provide numerous benefits over the devices and systems of the prior art. An exemplary restraining device  10  may be inserted laparoscopically and/or endoscopically, is minimally invasive, completely reversible and available for chronic placement without the risk of complications. Furthermore, use of a restraining device  10  to treat and/or support a targeted tissue or organ produces a reduced amount of negative side effects than the procedures of the prior art for similar indications. While embodiments of restraining devices  10  are presented with respect to specific anatomy and treatment examples, the various restraining devices  10  and methods  300  may be expanded for use in treating any organ, limb or body structure that would benefit from reshaping, restoring, or added support provided through a reversible, easy to use and easy to implement technique for chronic placement. 
     Prior art focuses on creating a restrictive line through “clamps” to mimic the gastric sleeve. The disclosure of the present application provides various loosely-fitting restraints (to prevent migration) and to affect motility of the stomach. The contractility or motility curve of the gastric tissue is substantially attenuated by an external restraint (as discussed below), thus affecting the movement of bolus through the stomach. Hence, the food volume will remain in the pouch longer and lead to earlier distension which affects neuroactivity and mechanosensory elements of satiety. Hence, the principle of the restraining devices  10  of the present disclosure is based on flow (motility) unlike previous art that focuses on restrictive which risks migration and erosion. 
     As described herein, placement of exemplary restraining devices  10  through the lower curvature can be easily implemented as opposed to procedures which approach the greater curvature where the liver and diaphragm are in the proximity. Furthermore, various clips, clamps, or perforated plates known in the art which transverse the stomach (as opposed to sleeve) can lead to substantial remodeling of the fundus which would lead to weight regain after a period of time. As such, the various connectors of the disclosure of the present application operate to prevent overall stretch of stomach and hence prevent remodeling. The stretch that leads to mechanosensory satiety in the restraining devices of the present disclosure occurs locally between the restraining springs or bars while still restraining the overall pouch. No such global containment of the gastric tissue is known in the prior art. Finally, various clips, clamps, or perforated plates known in the art would exert significant local stresses on the tissue which can lead to erosion or migration as the substantially restricted stomach would attempt to distend. Conversely, the first engaging component  12  and the second engaging component  16  of the restraining devices  10  of the present disclosure distribute the stress more uniformly over the plate and only restrain a relatively small pouch rather than a more substantial portion of the stomach transversely. 
     While various embodiments of implantable restraining devices, systems, and methods for using the same have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the disclosure. Indeed, this disclosure is not intended to be exhaustive or to limit the scope of the disclosure. 
     Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. Other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.