Abstract:
Medical devices, systems and methods are provided and are designed to stretch the stomach wall of a patient to treat obesity. Stretch devices attached to the stomach wall may trigger stretch receptors to expand the stomach into a state of apparent stretching, causing early onset of satiety thereby causing the patient to consume less food. Stretching of the stomach can be achieved by the attachment of stretch devices to the wall of the stomach. The devices may be expandable and contractible and, in some embodiments, may take the form of a device that expands following attachment to a wall of the stomach.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is related to U.S. Patent Application 61/591,316, entitled “Gastric Stretch Devices, Systems and Methods for Treatment of Obesity” filed on Jan. 27, 2012, incorporated by reference herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    The present disclosure relates to devices, systems and methods for treatment of obesity. 
         [0003]    Obesity is a major health concern in the United States and other countries. A significant portion of the population is overweight with the number increasing every year. Obesity is one of the leading causes of preventable death. Obesity is associated with several co-morbidities that affect almost every body system. Some of these co-morbidities include: hypertension, hyperglycemia, heart disease, stroke, high cholesterol, diabetes, coronary disease, breathing disorders, sleep apnea, cancer, gallstones, and musculoskeletal problems. An obese patient is also at increased risk of developing Type II diabetes. 
         [0004]    Multiple factors contribute to obesity, including physical inactivity and overeating. A variety of medical approaches have been devised for treatment of obesity. Existing therapies include diet, exercise, appetite suppressive drugs, metabolism enhancing drugs, surgical restriction of the gastric tract, and surgical modification of the gastric tract. In general, surgery is reserved for patients in whom conservative measures, such as monitoring caloric intake or controlling appetite with appetite suppressants, have failed. In addition, surgery is generally reserved for patients who are seriously, and sometimes morbidly, overweight. 
         [0005]    There have been many surgical approaches to obesity. For example, some patients have received implantation of one or more bulking prostheses to reduce stomach volume. A bulking prosthesis resides within the stomach and limits the amount of food the stomach can hold, theoretically causing the patient to feel a sensation of satiety. U.S. Patent Application Publication No. 20030040804 to Stack et al., for example, describes a tubular prosthesis that is designed to induce sensations of satiety within a patient. 
         [0006]    Another approach is restrictive surgery, which surgically makes the stomach smaller by removing or closing a section of the stomach. This procedure also reduces the amount of food the stomach can hold, causing the patient to feel full. U.S. Patent Application Publication No. 20020183768 to Deem et al., discloses various techniques for reducing the size of the stomach pouch to limit caloric intake, as well as to provide an earlier feeling of satiety. 
         [0007]    Another surgical procedure to treat obesity is the gastric bypass procedure. In the gastric bypass procedure, the surgeon creates a small stomach pouch to restrict food intake and constructs a bypass of the duodenum and other segments of the small intestine. This procedure limits the amount of food that can be ingested and subsequently digested or absorbed. 
         [0008]    Surgical procedures for treatment of obesity, such as those described above, tend to be highly invasive, and each form of surgery may involve complications. Restrictive surgery may entail a risk of vomiting, for example, and gastric bypass surgery may result in unpleasant consequences known as “dumping syndrome.” 
         [0009]    U.S. Pat. No. 6,540,789 to Silverman describes a technique for treatment of obesity involving introduction of an implant material into the stomach wall in the vicinity of the pyloric sphincter to inhibit emptying of the stomach. Silverman also describes introduction of an implant material to reduce distensibility and contractility of the stomach. 
         [0010]    U.S. Patent Application Publication No. 20100331617 to Forsell describes an operable stretching device implantable in an obese patient for stretching a patient&#39;s stomach wall via an external operation device. 
         [0011]    U.S. Patent Application Publication No. 20050245957 to Starkebaum et. al. hereby incorporated by reference in its entirety, describes devices and methods designed to bias stretch receptors in the stomach wall of a patient to treat obesity. Biasing of the stretch receptors by pre-stretching induces early sensation of satiety, causing the patient to consume less food. 
         [0012]    U.S. Patent Application Publication No. 20060173238 to Starkebaum, hereby incorporated by reference in its entirety, describes a dynamically controlled gastric occlusion device which may control the degree of gastric constriction of an occluding device based upon a monitored physiological parameter or based upon time. By dynamically controlling the degree of gastric constriction, the device limits the ingestion of food to reduce caloric intake so that the patient loses weight while permitting ingestion of caloric energy necessary to prevent malnourishment. 
       SUMMARY 
       [0013]    In general, the present disclosure relates to abdominal stretch devices and methods for treatment of obesity of a patient. Stretching an area of the gastrointestinal (GI) tract may induce an early sensation of satiety, causing a patient to consume less food. In accordance with the disclosure, stretching of the gastrointestinal tract can be achieved by attachment of stretch devices to the wall of the stomach. Stretch devices attached to the stomach wall may trigger stretch receptors to expand the stomach wall into a state of apparent stretching, causing early onset of satiety. In this manner, the devices are capable of discouraging excessive consumption of food without the use of appetite suppressant medications or more invasive surgical intervention. In various embodiments, the stretched condition of the stomach wall may activate stretch receptors to provide, in effect, an early warning system for cessation of meal consumption. Consequently, the devices according to the disclosure may counteract increased obesity and promote weight loss among obese patients. 
         [0014]    Some aspects in accordance with principles of the present disclosure relate to a stretch device or a plurality of stretch devices which may be attached to a wall of the stomach to stretch the stomach wall. 
         [0015]    In some embodiments, stretch devices may be attached to the inside or outside of the stomach wall at various locations (for example at the fundus or greater curvature) on or within any of the layers of the stomach for example, the serosal, muscle or mucosal layers of the stomach; or may be placed at any other location of the GI tract (for example the small intestine or pylorus). 
         [0016]    In yet further embodiments, stretch devices may be adjustable and may be expandable and/or contractible and may comprise actuation means. Stretch devices may comprise self-actuation or mechanical actuation means. In some embodiments, stretch devices may comprise adjustable elements and may comprise attachment assemblies for attaching the adjustable elements to tissue. Adjustable elements and/or attachment assemblies may comprise materials which self-expand following attachment to the stomach. Adjustable elements and/or attachment assemblies may comprise materials, polymers or alloys comprising any of the following materials or material properties: smart, memory, shape memory, superelastic, pseudoelastic, self-expanding, and/or self-reverting. In this manner, stretch devices may be easily and quickly implanted without the need for more complex or complicated operating systems to control the degree of stretch of the stomach tissue to which the stretch device or devices are attached. Stretch devices and/or portions of stretch devices according to further embodiments may comprise biocompatible metals, alloys or polymers. Stretch devices and/or portions of stretch devices may also comprise biodegradable, bioabsorbable or bioresorbable materials. In some embodiments, stretch devices may comprise coatings which may enhance biocompatibility and/or aid in anchoring, attachment, placement or delivery of the devices. 
         [0017]    Stretch device members or elements may take various forms or configurations and may comprise for example, adhesives, glues, stents, wires, filaments, coils, springs, telescoping elements, hooks, clips, sutures, anchors, pledgets, rivets, barbs, struts, screws, meshes, patches and/or sheets and may further comprise a unitary component or multiple components. 
         [0018]    Stretch devices may be attached to the stomach wall at one or more locations and may be attached in various configurations. Stretch devices may be attached to the stomach wall at linear or non-linear spaced-apart locations and may be oriented in any direction along the stomach wall. For example, stretch devices may be configured to stretch the stomach wall along the contours of the stomach wall. Stretch devices may stretch tissue of the stomach wall in one or more directions and in more one or more dimensions (e.g. two-dimensionally or three-dimensionally) and may, for example stretch the stomach wall in a radial fashion. 
         [0019]    Stretch devices in accordance with the present disclosure may be adapted for attachment to the stomach of a patient via placement devices and may be adapted to be delivered to locations along the stomach via laparoscopic or endoscopic surgical techniques. Systems according to some embodiments of the present disclosure may comprise laparoscopic or endoscopic delivery devices sized for introduction into a stomach of a patient via laparoscopic instruments or via the esophagus of a patient. A placement, tool and/or delivery device may hold a stretch device or devices or portions of a stretch device for delivery and attachment to the wall of the patient&#39;s stomach. As examples, the placement and/or delivery tools may take the form of a gripping member that grips a stretch device, or the placement tool may take the form of a device comprising a lumen such as a catheter, a hollow needle or a tube. 
         [0020]    Other aspects in accordance with principles of the present disclosure relate to a method of stretching a portion of a gastrointestinal tract of a patient and may comprise attaching a stretch device or devices to a stomach wall of a patient to expand the stomach wall and thereby induce a sensation of satiety in the patient. 
         [0021]    Various embodiments of the present disclosure are capable of solving at least some of the problems mentioned above. For example, devices, systems and methods in accordance with the present disclosure may provide a treatment for obesity that presents greater efficacy and lesser side effects relative to administration of conventional appetite suppressant medications. In some embodiments, devices of the present disclosure may be capable of being delivered laparoscopically or endoscopically and may thereby avoid the need for more highly invasive surgical procedures. Devices in accordance with the disclosure may thus be capable of avoiding substantial reconstruction of the stomach, and offer reduced damage, recovery time, and side effects. 
         [0022]    The details of one or more embodiments of the present disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]      FIG. 1  is a cross-sectional diagram of the interior of a stomach with stretch devices placed at various locations along the stomach wall. 
           [0024]      FIG. 2A  is a diagram of the exterior of a stomach with an embodiment of a stretch device and in a contracted condition attached to a stomach wall. 
           [0025]      FIG. 2B  is a diagram of the exterior of a stomach with an embodiment of a stretch device and in an expanded condition attached to a stomach wall. 
           [0026]      FIG. 3A  is a diagram of the exterior of a stomach with portion of another embodiment of a stretch device. 
           [0027]      FIG. 3B  is a diagram of another embodiment of a stretch device in a contracted condition. 
           [0028]      FIG. 3C  is a diagram the device of  FIG. 3B  in an expanded condition. 
           [0029]      FIG. 4A  is a diagram of the exterior of a stomach with portion of another embodiment of a stretch device attached to a wall of the stomach and in an expanded condition. 
           [0030]      FIG. 4B  is a diagram of another embodiment of a stretch device comprising a tether. 
           [0031]      FIG. 4C  is a diagram of the device of  FIG. 4B  with the tether engaged. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]      FIG. 1  is a cross-sectional diagram of the interior of a stomach  13 , including esophagus  12 , lower esophageal sphincter  14 , pyloric sphincter  16 , fundus  18 , and greater curvature  19 , with stretch devices  10  (three stretch devices  10  are depicted in  FIG. 1 ) attached to stomach wall  21 . Aspects of the present disclosure provide a stretch device  10  securable or implantable to a stomach wall  21 . In general terms, stretch devices of the present disclosure, such as stretch devices  10 —schematically illustrated in  FIG. 1  as well as stretch devices  20 ,  30 ,  40  ( FIGS. 2 ,  3 ,  4 ), may include an adjustable member  17  and one or more attachment assemblies  32  (referenced generally) which may be integrally formed with adjustable member  17  or may include component or components separate from adjustable member  17 . It is to be understood that stretch devices  20 ,  30 ,  40  may comprise features described herein with specific reference to stretch device  10 . As described in greater detail below, the adjustable member  17  is transitionable from a contracted state prior to implantation to an expanded state following implantation. The attachment assembly  32  can assume various forms, described below, that are capable of securing an adjustable member  17  to the stomach wall  21  in a manner such that upon transitioning of the adjustable member  17  to the expanded state following implantation, the stretch device  10  transitions to an expanded condition and causes stretching of stomach stretch receptors. While  FIG. 1  illustrates three stretch devices  10 , any other number is equally, acceptable, for example, only one stretch device  10 , or more than one stretch devices  10 . 
         [0033]    Stretch devices  10  (also  20 ,  30 ,  40 ) as hereinafter described with reference to  FIGS. 2 ,  3 , and  4 ) can be implanted within or attached to the outside of the stomach  13 , the inside of the stomach  13  and/or within portions of the stomach wall  21 . Stomach wall  21  of a human stomach  13  generally includes four layers. With reference to  FIG. 1 , the innermost layer, mucosa  22 , generates digestive juices. Submucosa  24  contains blood vessels that provide blood and oxygen to mucosa  22 . Muscularis  26 , a smooth muscle layer embedded with nervous plexus, contracts to mix food with digestive juices generated by mucosa  22 . Serosa  28 , the fourth and outermost layer, protects the other layers and confines digestive juices to stomach  13 . 
         [0034]    Stretch device  10  or portions of stretch device  10  may be attached to the serosa, the mucosa, the submucosa or the muscularis  26 , which contains the stretch receptors. The stretch receptors are coupled to the nervous system via the vagus nerves, and signal the patient when stomach  13  reaches a stretch point indicating a large quantity of food. With stretch device  10  attached and expanded, the patient perceives that the stomach has reached a stretch point indicating fullness much earlier during the course of the meal and at a point at which the stomach is not actually full. Stretch device  10  may be attached to or may embed in only one or several or portions of the layers of the stomach wall  21 . Stretch device  10 , for example, may attach to the stomach wall  21  at the serosa  28  at at least two spaced apart locations. Stretching or expansion of stretch device  10  following attachment to the stomach tissue may cause the tissue or layers of the stomach tissue T between the areas of attachment of stretch device  10  to expand as adjustable member  17  and thereby device  10  expands and may thus expand stretch receptors in the stomach wall  21  and induce a sensation of satiety in a patient. 
         [0035]    As further shown in  FIG. 1 , stretch device  10  may be attached to the stomach wall  21  at the fundus  18  at spaced apart positions to provide localized stretching at several different points. Localized stretching may occur in more than one dimension, for example, localized stretching may occur two-dimensionally or three-dimensionally (e.g., along the contours of stomach wall  21 ). Stretch device  10  may be attached to stomach wall  21  in other regions of stomach  13 , other than fundus  18 , such as greater curvature (e.g. stretch device  10 C). However, stretch receptors tend to be concentrated within fundus  18 . Accordingly, in some embodiments, stretch device  10  may be primarily or solely attached to fundus  18 , where they are expected to be most effective in expanding or stretching stretch receptors. In other words according to some embodiments, stretch device  10  may be generally located only at the region of fundus  18  and nowhere else. In other embodiments, stretch device  10  may be attached to fundus  18  and greater curvature  19 , or solely at the region of greater curvature  19 . 
         [0036]    Adjustable member  17  (referenced generally) may be formed from a smart memory, shape memory, superelastic, pseudoelastic, self-expanding, and/or self-reverting material, alloy or polymer. Following attachment of an adjustable member  17  to a location along the stomach  13 , adjustable member  17  may assume an expanded or undeformed state thereby transitioning stretch device  10  to an expanded condition. The expanded state of adjustable member  17  may be described as a memory-set or shape memory set state. In some embodiments adjustable member  17  may comprise biocompatible materials of alloys which are not shape memory materials. With this construction, following attachment of stretch device  10  to tissue, stretch device  10  may be mechanically expandable upon attachment such as via a spring-like mechanism. As described above, attachment assembly  32  may be integrally formed with adjustable member  17  and may comprise the same material as adjustable member  17 . Alternatively, attachment assembly  32  may comprise materials different from adjustable member  17 . Attachment assembly  32  may comprise shape memory materials as described above and may transition from a first delivery state to a second attachment state separate from the transitioning of adjustable member  17  from a contracted state to an expanded state. 
         [0037]    Stretch device  10  may be expanded to a condition with a size sufficient to expand stretch receptors within stomach wall  21 . When expanded in this way, stretch device  10  exerts a localized stretching force on stretch receptors in stomach  13 . The stretch receptors are coupled to the enteric nervous system of a patient. When triggered by the stretching force, the stretch receptors induce a sensation of satiety in the patient, and discourage the patient from consuming an excessively large meal. The role of stretch receptors in human gastric function is discussed, for example, in A. S. Paintal, “A study of gastric stretch receptors; their role in the peripheral mechanism of satiation of hunger and thirst,” J. Physiol. Nov. 29, 1954; 29; 126(2):255-70. 
         [0038]    Stretch device  10  stretches stomach wall  21  into a stretched condition that either triggers the stretch receptors or causes earlier triggering of the stretch receptors during the consumption of a meal. Hence, even though the stomach may not contain a substantial portion of food at the outset of a meal, implanted or attached stretch device  10  has already stretched the stretch receptors into a condition that simulates the presence of a substantial portion of food. Consequently, during the course of a meal, stomach  13  requires a smaller amount of food to produce a sensation of satiety, which causes the patient to stop eating. 
         [0039]    Stretch device  10  is configured such that even in an expanded state, the device does not significantly change the overall size or contents of stomach  13 , but provides a localized modification of the stomach wall  21 . This modification affects the response of the patient&#39;s enteric nervous system and the amount of food consumed by the patient, thereby preventing increased obesity and possibly causing or assisting in weight loss. In some cases, stretch device  10  may be explanted after a desired course of obesity treatment has been achieved. 
         [0040]    Stretch device  10  may be implanted or attached surgically from the serosal aspect of stomach  13  (i.e., from the outer surface) or endoscopically from the mucosal aspect of the stomach (i.e., from the inside surface) of the stomach. The esophagus  12  of the patient may be intubated with the endoscopic delivery device via the oral or nasal passage under general anesthesia. Additionally, surgical implantation may involve laparoscopic techniques. In this manner, a highly invasive surgery can be avoided, and recovery time can be shortened. 
         [0041]    One embodiment of a stretch device (stretch device  20 ) is shown in  FIGS. 2A and 2B  and generally includes an adjustable member  17  and at least one attachment assembly  32 .  FIG. 2A  is a diagram of the exterior of stomach  13  with an adjustable member  17  of stretch device  20  in a first state and attached to the stomach wall  21 . As shown in  FIG. 2A , adjustable member  17  in a first state may comprise a deformed, contracted, constrained, delivery, and/or shortened state. With continued reference to  FIG. 2A , adjustable member  17  may comprise a first end  34  and a second end  36 . One or both ends  34 ,  36  may comprise an attachment assembly  32  for attaching adjustable member  17  to tissue. Adjustable members  17  may comprise, as several non-limiting examples: wire, filaments, coils, stents, springs, telescoping elements; patches, meshes, struts and/or sheets. Attachment assemblies  32  may comprise, as several non-limiting examples: adhesives, glues, wires, filaments, coils, springs, hooks, clips, sutures, anchors, pledgets, rivets, barbs, screws. As shown in  FIG. 2A , opposing ends  34 ,  36  of adjustable member  17  may be implanted or attached at spaced apart positions along or at fundus  18  of stomach  13 . 
         [0042]    As depicted in  FIG. 2A , adjustable member  17  may comprise a longitudinal length comprising a first, contracted length L 1  and, following attachment to tissue of stomach  13 , adjustable member  17  (and thereby device  20 ) may expand in a longitudinal direction to a second state which may comprise an expanded longitudinal length L 2  as depicted in  FIG. 2B . As further depicted in  FIG. 2B , adjustable member  17  in a second state may comprise an undeformed, expanded, unconstrained, or lengthened state. Adjustable member  17  may be configured to self-expand to the second state. For example, adjustable members  17  and/or attachment assemblies  32  may comprise self-expanding springs or may comprise various shape memory materials or alloys and thus may self-assume (e.g. self-expand, self-revert) an undeformed, shape memory-set or memory-set configuration. Shape memory materials (also described, for example, as smart materials or memory materials) or alloys can exhibit pseudoelastic or superelastic behavior when deformed at a temperature slightly above a transformation temperature. The transformation temperature may be defined as the temperature at which a shape memory alloy finishes transforming from martensite to austenite upon heating (i.e., A t  temperature). At least a portion of the shape memory material or alloy is converted from its austenitic phase to its martensitic phase when the material or alloy is in its deformed configuration. As the stress or constraint is removed, the material undergoes a martensitic to austenitic conversion and springs back to its undeformed (e.g. unconstrained, expanded) configuration. In order for the pseudoelastic material to retain sufficient expansive force in its undeformed or expanded configuration, the material should not be stressed past its yield point in its deformed or contracted configuration to allow complete recovery of the material to its undeformed configuration. Shape memory materials or alloys may include additional elements which affect the yield strength of the material or the temperature at which particular pseudoelastic or shape transformation characteristics occur. Shape memory materials or alloys may also be heat activated or may comprise a combination of heat activation and pseudoelastic properties to allow the material to assume an undeformed state as is well known by those skilled in the art. One such shape memory alloy which adjustable members  17  (and/or attachment assemblies  32 ) may comprise is nitinol. Other shape or smart memory alloys or polymers as are known in the art may also be utilized. 
         [0043]      FIGS. 2A and 2B  depict an anterior side of stomach  13  for ease of illustration. It should be understood, however, that a stretch device ( 10 ,  20 ,  30 ,  40 ) or devices as depicted on the anterior side, may likewise be implanted on or attached to a posterior side of stomach  13 . In other embodiments, stretch devices ( 10 ,  20 ,  30 ,  40 ) may be implanted on or attached to a single side or two sides, i.e., posterior, anterior, and/or lateral. In each case, stretch devices ( 10 ,  20 ,  30 ,  40 ) are implanted as relatively small contracted objects that then expand following implantation or attachment, and thereby stretch the stretch receptors in fundus  18  of stomach  13 . Portions of a stretch device or devices ( 10 ,  20 ,  30 ,  40 ) may embed or attach to one or more layers of the stomach wall  21 . 
         [0044]    In the examples of  FIGS. 1-4 , adjustable members  17  are depicted as essentially crescent-shaped elements. However, in other embodiments, adjustable members  17  may comprise a variety of other shapes, e.g., substantially spherically shaped, rod or cylinder-shaped, sheet-like, curved surfaces, or irregularly shaped and may comprise a variety of different forms (e.g., wires, coils, springs, stents, sheets, patches, meshes and the like) as previously described above with reference to  FIG. 2A . In some embodiments adjustable members  17  are configured for attachment to the stomach wall  21  such that when adjustable members  17  are in an undeformed, expanded, unconstrained, or lengthened state, the stomach wall  21  is stretched in more than one dimension. Adjustable members  17  may comprise a single member or a series of elements joined or attached together. In some embodiments, adjustable member  17  may comprise multiple elements arranged in a telescoping manner to allow for expansion and contraction of the adjustable member  17  and thereby cause expansion and contraction of device  10 . Adjustable member  17  may be contracted or constrained in several ways for delivery and attachment of device  10  to a targeted area of tissue. In this manner, a system (not shown) may comprise a stretch device  10  and a placement tool (not shown) for delivery and attachment of stretch device  10  to the stomach. Placement tool (no shown) may take various forms and may for example comprise a holding member, a gripping member, a hollow tube or a catheter (not shown). Devices  10  and/or placement tool may be insertable into endoscopic or laparoscopic surgical tools for less invasive delivery of stretch device  10 . Stretch device  10  may comprise a configuration which may conform to a stomach wall  21  and may comprise a low profile as compared to the tissue area to which the device  10  is attached. 
         [0045]    The amount of stretch the stomach undergoes after attachment and expansion of stretch device  10  may be dependent upon the patient and may for example, be an amount of stretch sufficient to create a sensation of satiety sufficient to discourage the patient from consuming an excessively large meal. In some embodiments the stretch ratio of the stomach tissue from an at least partially stretched tissue state may be at least approximately two times and more particularly may be approximately twenty times. In some embodiments the amount of stretch of tissue of the stomach may comprise an amount sufficient to create a hormonal or neuronal response thereby inducing a sensation of satiety in the patient. 
         [0046]    Another embodiment of a stretch device (stretch device  30 ) is shown in  FIGS. 3A-3C  and generally include an adjustable member  17  and at least one attachment assembly  32  comprising plication anchors  42 . Adjustable members  17  may take any form as described above. The anchors  42  are described in greater detail below and are generally configured to promote attachment of the adjustable member  17  to the stomach wall  21 . Stretch device  30  is shown on the outside of stomach  13 . It is to be understood that device  30  may be attached to various locations along the stomach wall  21  as described herein with reference to stretch device  10  and may be attached to the inside of the stomach wall. With reference to  FIG. 3A , a portion of stretch device  30  is depicted and shows an embodiment of attachment assemblies  32  comprising plication anchors  42  placed at two spaced apart locations on stomach  13 . Tissue plications  41  are created by gathering or pinching stomach tissue together and anchoring the plication  41  with a plication anchor  42 . Tissue plications  41  may be formed using a vacuum source (not shown) to suction tissue to be pinched together to create a plication  41 . U.S. Pat. No. 6,592,596 to Geitz, incorporated by reference herein in its entirety, describes devices and methods for creating and securing a tissue fold, for example securing a region of the stomach circumferential to the esophageal opening back onto the esophagus, during an endoluminal medical procedure to alleviate the effects of Gastroesophageal Reflux Disease. Other methods of creating tissue plications may also be utilized, for example, mechanically pinching or holding tissue together with surgical tools, as is known in the art. Each of plication anchors  42  may comprise a plication anchor first end  44  and a plication anchor second end  45 . The plication anchor first ends  44  may be configured to attach to an adjustable member  17  as depicted in  FIG. 3B . Plication anchor  42  may comprise a cross member  46  which may pierce tissue of tissue plication  41  such that an anchor second end  45  abuts tissue plication  41  at first tissue plication end while an anchor first end  44  abuts tissue plication  41  at a second tissue plication end to thereby secure the tissue plication  41  between ends anchor ends  44  and  45 . Plication anchor  42  may comprise a single component or multiple components. For example, plication anchor first and/or second ends  44 ,  45  may be releasably attached to plication anchor cross member  46 . Alternatively plication anchor first and/or second ends  44 ,  45  may be integrally formed with cross member  46 . Plication anchor  42  may be formed of any suitable material that is biocompatible. Plication anchor  42  may be formed of a shape memory material as described herein with reference to stretch devices  10 . Plication anchor  42  or portions of plication anchor  42  may comprise a first state and a second state and may self-assume a second state upon attachment to tissue. Plication anchor first and second ends  44 ,  45  may comprise a variety of configurations and for example, may take the form of a circular, semi-circular rectangular, pointed, piercing, blunt or other object and may, for example, comprise a pledget. Plication anchor first and second ends  44 ,  45  may act in concert to compress gastrointestinal tissue therebetween. The compressive force of plication anchor  42  may result from the material properties (e.g. shape memory materials) or construction of plication anchor  42 . Plication anchor  42  may be configured in a manner so as to allow plication anchor cross member  46  to be adjustable. For example, plication anchor  42  may comprise a spring or folded material and/or may be adjustable. Plication anchor  42  additionally may be expandable and/or contractible. 
         [0047]    As depicted in  FIG. 3A , two plication anchors  42  are shown with tissue plications  41  formed between plication anchor ends  44 ,  45 . In  FIG. 3B , an adjustable member  17  is depicted as attached to plication anchor end  44  at each of adjustable member ends  34 ,  36  while adjustable member  17  is in a first contracted state and has a length L 3  in the first, contracted state. With reference to  FIG. 3C , adjustable member  17  is depicted in an expanded or second state having an expanded length L 4 . With continued reference to  FIG. 3C , the tissue, T of stomach wall  21 , located between plications  41  is stretched as stretch device  30  is expanded to the length L 4 . The amount of stretch of tissue T may be as described previously herein and thus may be an amount sufficient to create a sensation of satiety in a patient. It is to be understood that any number of plication anchors  42  may be placed along the stomach wall to form any number of tissue plications  41 . Likewise, any number of adjustable members  17  may be attached to or between plication anchors  42 . 
         [0048]    Another embodiment of a stretch device (stretch device  40 ) is shown in  FIGS. 4A-4C  and generally includes an adjustable member  17  and at least one attachment assembly  32  and further includes a tether  48 , described in greater detail below.  FIG. 4A  depicts a portion of stretch device  40  and illustrates adjustable member  17  in a second expanded state and attached to a stomach wall  21  between plication anchors  42  as previously described herein.  FIG. 4A  depicts plication anchors  42  as the attachment assemblies  32 . It is to be understood that device  40  may comprise any other of the attachment assemblies  32  as described above. In  FIG. 4B , a tether  48  is attached to adjustable member  17 . Tether  48  is generally configured to adjust or aid in adjusting adjustable member  17 . Alternatively tether  48  may also be attached to plication anchors  42  at either of plication anchor first and second ends  44 ,  45  or to plication anchor cross member  46 . Alternatively, tether  48  may be attached to tissue plication  41 . Tether  48  may be expandable and/or contractible and may be constructed of any suitable biocompatible material and may comprise for example metals and/or polymers as described previously herein. Tether  48  may be tightened or foreshortened to reduce an adjustable member  17  expanded length L 5  and thereby reduce an amount of stretch of tissue T along the stomach wall  21 . Tether  48  may be actuated such as via a squiggle motor (not shown) to gather in or let out a length of tether  48 . Gathering in of tether  48  may thereby reduce the length L 5  of expanded adjustable member  17  to a contracted adjustable member length L 6 . 
         [0049]    Stretch devices  10 ,  20 ,  30 ,  40  according to the disclosure may additionally comprise electrodes at various locations for stimulation of stomach tissue. U.S. Patent Application Publication No. 20110071589 to Starkebaum et. al, incorporated by reference herein in its entirety, describes systems, devices and techniques for delivering electrical stimulation therapy to a patient. 
         [0050]    Although the present disclosure has been described with reference to embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.