Abstract:
The present invention relates to a device for intermittently obstructing a bodily opening, such as a gastric opening, and includes a proximal member connected to a distal member by a tether. The proximal member is formable from an elongated and narrower configuration to a contracted or expanded but wider configuration. When employed in the stomach, the device may be arranged transluminally with the distal member disposed in the duodenum and the proximal member disposed against the pyloric valve, intermittently occluding the pyloric valve and preventing or delaying, the flow of gastric contents through the pyloric valve.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of International Application No. PCT/US2014/024475 filed Mar. 12, 2014, which claims the benefit of priority to U.S. Provisional Application No. 61/791,433 filed Mar. 15, 2013, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a gastro-intestinal device for treating obesity and other medical conditions. More particularly, the present invention relates to a device that is positioned transluminally in a patient&#39;s gastro-intestinal tract to intermittently obstruct or reduce the flow of gastric contents. 
       BACKGROUND OF THE INVENTION 
       [0003]    Obesity is a condition of epidemic proportions in the United States. Recent government studies have indicated that up to 40% of Americans are obese and that, among those, almost 20% are morbidly obese. Obesity is not the problem in and of itself, but is the source of multiple pathological conditions, including cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent studies have indicated that obesity can reduce a person&#39;s lifespan by an average of three years in adults and twenty years in children. 
         [0004]    Many attempts have been made in the prior art to provide medications, devices, and surgical procedures for the treatment of obesity, all of which either have serious side effects or are basically ineffective. For example, various diets, supplements and pharmaceuticals have been developed, and marketed, but none have shown any significant benefits to date in the treatment of obesity with the exception of some pharmaceuticals, which have unfortunately been found to cause a number of serious, life-threatening medical conditions. To date, there are no commercially available supplements or drugs that have been proven to be effective in promoting significant weight loss and at the same time that are free from serious collateral side effects. 
         [0005]    Recognizing that no cure has been developed to date that is both effective and safe, the medical industry has introduced more extreme procedures, an example of which is the Roux-En-Y gastric, bypass. This extensive and invasive surgery is highly effective but is also potentially lethal, with a 1-2% mortality rate, a six month recovery period, and a cost of tens of thousands of dollars, yet it is becoming increasingly popular because other available treatments do not produce the desired results. Gastric reduction, or simply removing a large segment of the stomach, another procedure that is similar to gastric bypass and that, like gastric bypass, has also been associated with potentially lethal complications. Data from recent studies have indicated that even in the lowest risk groups, obesity surgery causes an average one-year mortality rate of nearly 5%. 
         [0006]    In another attempt to treat obesity, devices have also been developed in the prior art that are aimed at providing a sense of fullness to a patient, so to cause the patient to reduce food intake. Such devices may be configured as stents that support the stomach or the pyloric valve to or that may be configured as permanent occluders. Unfortunately, these devices are implanted in the patient on an essentially permanent basis and typically include complex mechanical or electrical features that may stop working properly over time or that may require maintenance from time to time. Examples of such devices in the prior art can be found m U.S. Pat. Nos. 5,509,888; 6,067,991; 6,527,701; 6,689,046; 7,011,621; 7,037,344; 7,120,498; 7,122,058 and 7,167,750, and in U.S. Patent Application Publications Nos. 2004/0172142; 2005/0273060; 2007/0016262; 2007/0027548; and 2007/0081224. 
         [0007]    Evidence has been developed showing that benefits can be derived from reducing gastroduodenal flow. In unpublished, but recently presented data at the American Society for Bariatric Surgery conference of June 2003, stimulation of the gastric vagus nerve with subsequent reduction in gastric motility resulted in a loss of over 20% of excess weight over a nine month period. Furthermore, there is data suggesting that gastric vagotomy is also effective in the treatment of obesity trough a similar mechanism. Unfortunately, these therapies require highly invasive, sometimes irreversible, surgical procedures, making undesirable for a large segment of the obese population. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    It is an object of the present invention to provide a device for the treatment of obesity and related conditions that intermittently obstructs a transluminal passage, such as a gastric opening. 
         [0009]    It is also an object of the present invention to provide a device for the treatment of obesity and related conditions that is well tolerated by the stomach and in general, by the gastro-intestinal tact. 
         [0010]    It is a further object of the present invention to provide a device for the treatment of obesity and related conditions that can be implanted and removed with medical procedures that are safe and relatively simple to perform. 
         [0011]    Briefly, the device of the present invention operates as a transluminal device that obstructs the pylorus or other organ on an intermittent basis and that causes a reduced flow of gastric contents into the intestinal tract. The device of the present invention may just occupy space in the stomach and occlude the pyloric valve from time to time, or also may partially obstruct the duodenum or the small intestine, reducing overall gastrointestinal transit. The intermittent blockage of the gastrointestinal tract results in weight loss and also in an increased or sustained feeling of fullness by the patient. 
         [0012]    The device of the present invention can be placed and removed with simple endoscopic procedures and is completely reversible. In particular, the device of the present invention can be inserted and removed orally, nasally or transcutaneously and, in certain embodiments, can be triggered externally or can be caused to expand or can self-expand once in the gastrointestinal space. 
         [0013]    In one embodiment, a device according to the present invention includes a proximal member oriented in the direction of the stomach after implantation and a distal member oriented in the direction of the duodenum after implantation that are connected by a tether. 
         [0014]    The proximal member is composed of a first occluding member surrounded by an apron member. The first occluding member is formable from an elongated, narrower configuration to a contracted, wider configuration, while the apron member has an essentially cylindrical portion that surrounds the first occluding member and an essentially conical portion that connects the apron member to the tether, providing the apron member with a funnel-like shape. In one embodiment, the cylindrical portion is spaced from the first occluding member by an interstice, and the cylindrical and conical portions may have different wall thickness. 
         [0015]    The first occluding member may be formable from the narrower configuration to the wider configuration by injecting a substance within the first occluding member, or may have a solid structure that can be compressed to assume an expanded shape, in order to transition form the elongated configuration to the wider configuration. 
         [0016]    In one embodiment, the elongated configuration exhibits a helical contour with a plurality of turns, and the wider configuration is formed from the helical configuration by nesting the turns one adjacent to the other to provide a bulbous body. The wider configuration is then locked in place by engaging a connecting member at the proximal end of the first occluding member with a mating cavity at the distal end of the first occluding member. This may be achieved by having a clinician pull on a string coupled to the connecting member in the direction of the mating cavity. 
         [0017]    In one embodiment, such coupling, string extends outside of the device along its entire length and then enters a lumen running from the first occluding member to the second occluding members through the tether. When entering the first occluding member, the string is looped through the connecting member and is removable from the device after the connecting, member has engaged the matching cavity. The proximal end of the first occluding member may be reinforced to increase its resistance to tear during the compression of the first occluding member by including a reinforcing material in at least part of the structure of the proximal end. 
         [0018]    The transformation process from the elongated configuration to the wider configuration is reversible so that the device can be implanted in the stomach in the elongated configuration, reside in the stomach and/or gastro-intestinal tract in the wider configuration, and be removed from the stomach through the esophagus in the elongated configuration. In one embodiment, the wider configuration reverses to the elongated configuration by severing the connecting member from the proximal end, for example, by having a clinician cut a string coupling the connecting member to the proximal end or to a release member in the proximal end. 
         [0019]    A device according to the present material is manufactured from a material that is biocompatible, that is able to withstand the gastrointestinal environment, and that prevents or anyways minimizes abrasion of the walls of the stomach and duodenum, particularly of the pyloric valve, in one embodiment, the device is manufactured from a resilient plastic material, for example, from a silicone material, and the apron member may be constructed to be flexible enough to reverse from a position surrounding a portion of the tether to a position surrounding the first occluding member, in order to facilitate insertion in the stomach according to one method of use. 
         [0020]    The second occluding member also may have a bulbous shape, like a pod, and include an insert having a heavier weight than the remainder of the second occluding, member, so to facilitate disposition and retention in the duodenum. 
         [0021]    The device of the present invention is suited not only for the treatment of obesity, but also for treating other ailments, such as improper glucose tolerance in a diabetic or prediabetic subject and the progression of diabetes itself by inhibiting fasting insulin secretion or glucose-stimulated insulin secretion. The resent device is also suited for treating other ailments deriving from obesity, including hyperphagia, dyslipidemia, Prader Willi syndrome, Froelich&#39;s syndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, and IV. 
         [0022]    The device of the present invention may also include sensors or transmitters to provide feedback and other data to an intra-corporeal or extra-corporeal processor, or may carry one or more compounds stored in a reservoir within the device or coated on the device. In one embodiment, insulin is released into the gastro-intestinal tract by disposing an insulin reservoir in the distal member of the device. Such a release of insulin may be controlled by the size of the orifice between the reservoir and the outer environment, or by a time-controlled actuator, or by an actuator controlled by one or more sensors, for example in response to detection of sugar in the gastro-intestinal tract. 
         [0023]    Other embodiments of the present invention, methods of use of a device manufactured according to the present invention, and methods of treatment of a variety of ailments using, the device of the present invention are discussed in detail in the following sections. Additionally, alternative devices and their methods of use which may be used with the features described herein in various combinations are further described in detail in U.S. patent application Ser. No. 12/205,403 filed Sep. 5, 2008 (US Pub. 2009/0198210); U.S. patent application Ser. No. 12/352,497 filed Jan. 12, 2009 (US Pub. 2009/0182357); and U.S. patent application Ser. No. 12/352,508 filed Jan. 12, 2009 (US Pub. 2009/0182358), each of which is incorporated herein by reference in its entirety for any purpose. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]    The drawings constitute a part of this specification and include exemplary embodiments of the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention. 
           [0025]      FIG. 1A  illustrates a perspective view of a first embodiment of the invention in the elongated, narrower configuration. 
           [0026]      FIG. 1B  illustrates a perspective view of the embodiment of  FIG. 1A  in the contracted, wider configuration, 
           [0027]      FIGS. 1C-1E  illustrate respectively a cross-sectional view of the proximal member of the embodiment of  FIG. 1B , to which a protective cap has been added ( FIG. 1C ) a side view of the embodiment of  FIG. 1B  with the protective cap ( FIG. 1D ); and a cross-sectional view of the embodiment of  FIG. 1D  ( FIG. 1E ). 
           [0028]      FIG. 1F  illustrates a cross-sectional side view of one example of a device having a sensor incorporated within for confirming or detecting whether the occluding member has been locked into its deployment configuration. 
           [0029]      FIGS. 2A-2C  illustrate respectively a cross-sectional side view and top and bottom end views of another embodiment. 
           [0030]      FIGS. 2D-2E  illustrate respective side and cross-sectional perspective views of the embodiment of  FIGS. 2A-2C . 
           [0031]      FIGS. 3A-3B  illustrate side and cross-sectional side views, respectively, of yet another embodiment where an occluding member is separately fabricated and removably attachable within an apron member. 
           [0032]      FIG. 3C  illustrates a cross-sectional side view of an assembled device from  FIGS. 3A and 3B . 
           [0033]      FIGS. 4A and 4B  show perspective views of a helical assembly having, a proximal member reconfigured from its elongated configuration into its enlarged, coiled and nested configuration. 
           [0034]      FIGS. 5A and 5B  show cross-sectional side and perspective views of the proximal member to illustrate detail features for locking the proximal member into its enlarged and compacted configuration. 
           [0035]      FIGS. 6A and 6B  show perspective and cross-sectional perspective views of a covered obstructing assembly. 
           [0036]      FIG. 7  shows a perspective assembly view of the various components which may form the covered embodiment. 
           [0037]      FIG. 8  shows a partial cross-sectional perspective view of the covering having a distal hub and attachment collar within the receiving, space. 
           [0038]      FIGS. 9A-9C  illustrate partial cross-sectional perspective views of an example showing how the coiled member may be deployed within the covering. 
           [0039]      FIG. 10  shows one variation of a delivery assembly. 
           [0040]      FIGS. 11A and 11B  show partial cross-sectional views of the device placed within the stomach. 
           [0041]      FIG. 12A  shows a perspective view of an optional access tube positioned through the esophagus for removal of the device from a patient. 
           [0042]      FIG. 12B  shows a perspective view of a grasper brought into contact with a release mechanism. 
           [0043]      FIGS. 12C and 12D  show an example of the proximal member being unlocked and removed from a stomach in its elongate configuration. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0044]    Detailed descriptions of embodiments of the invention are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, the specific details disclosed herein are not to be interpreted as limiting, but rather as a representative basis for teaching one skilled in the art how to employ the present invention in virtually any detailed system, structure, or manner. 
         [0045]      FIG. 1A  depicts a first embodiment of the invention, which is configured for insertion into a patient&#39;s organ, typically the stomach. Device  30  includes a proximal member  32  and a distal member  34 , which are connected one to the other by a tether  36 . The relative sizes of proximal member  32  and of distal member  24  are such that, after insertion into the stomach of a patient, the natural contractions of the stomach and, in general, the movements of the patient induce distal member  34  to enter the pyloric part of the gastro-intestinal tract and the duodenum, while proximal member  32  is retained in the stomach and cannot move beyond the pyloric valve because its diameter is larger than the pyloric valve opening. 
         [0046]    More particularly, proximal member  32  includes a first occluding member  38 , disposed in a central position within an apron member  40 . First occluding, member  38  may be formed from an elongated, narrower configuration as shown in  FIG. 1A  to a contracted, wider configuration as shown in  FIG. 1B . In the embodiment illustrated in  FIG. 1A , first occluding member  38  has a helical design with a plurality of turns  42 , which are configured to nest one adjacent to the other to assume the compact, bulbous shape illustrated in  FIG. 1B . 
         [0047]    Apron member  40  wraps around first occluding member  38 , providing proximal member  32  with a enlarged diameter and preventing the passage of proximal member  32  through the pyloric valve. In one variant of the present embodiment, apron member  40  includes an essentially cylindrical proximal portion  44  connected to an essentially conical distal portion  46  that extends from tether  36  to proximal portion  44 . This configuration of apron member  40  is designed to provide an intermittent plugging effect on the pyloric valve and to avoid or anyways minimize abrasive contact with the wall of the pyloric valve during such plugging effect, so to prevent or minimize patient discomfort and irritations or even lacerations to the mucosa of the stomach and, in general, to the gastro-intestinal tract. 
         [0048]    Distal portion  46  may have a smaller wall thickness than proximal portion  44 , both providing a gentler, suppler contact with the pyloric valve, and also facilitating the reversal of apron member  44  during insertion into a patient&#39;s stomach from a position substantially aligned with tether  36  to the position that wraps around first occluding member  38 , as explained in greater detail below. 
         [0049]    In different variants of the present embodiment, apron member  40  may extend proximally for various lengths, surrounding first occluding member  38  partially or completely. Further, in different variants of the present embodiment, apron member  40  may be spaced from first occluding member  38  at various distances to create an interstice  48  of different amplitudes between first occluding member  38  and apron member  40 . 
         [0050]    Second occluding member  34  may exhibit a variety of contours and in general, is shaped to facilitate its transition out of the stomach and into the duodenum, and to avoid or minimize abrasive contact with the walls of the stomach and of the pylorus. In one embodiment, second occluding member  34  has a bulbous shape, essentially formed by two rounded, frusto-conical portions  50  connected at their wider bases. 
         [0051]    Device  30  may be manufactured from a variety of materials, for example, from a resilient plastic such as a silicone or urethane plastic, which may be reinforced in selected portions. In general, the selected material should be biocompatible, resistant to the stomach environment, for example to stomach acids, and soft to the contact with the stomach and duodenal walls. The desired material should also provide device  30  with the desired shape while retaining sufficient flexibility for the insertion process in the stomach, for later reverting to the desired position within the gastro-intestinal tract, and for adapting to the various movements of the stomach and, in general, of the body of the patient. 
         [0052]    Inserts may be integrally included within the body of device  30  to increase certain mechanical properties in certain areas. For example, an insert such as a metallic cylinder) may be embedded within second occluding member  34  to increase weight and to facilitate retention by gravity within the pylorus. Another insert (such as a fabric piece) may also be embedded in proximal end  52  of first occluding member  38 , increasing resistance to tear when proximal end  52  is pulled outwards to extend first occluding member to the configuration of  FIG. 1 , or inwards to stabilize first occluding member in its contracted, wider configuration, as explained in greater detail below. 
         [0053]    The insertion of device  30  in a patient&#39;s stomach will now be described with reference to  FIG. 1C . It should be noted that  FIG. 1C  illustrates, among other things, one variant of the embodiment of  FIGS. 1A and 1B , in which a stabilizing cap  54  is added to maintain first occluding member  38  in the contracted, wider configuration, and also to increase bulk and to prevent the introduction of food or other gastric products within interstice  48 . 
         [0054]    In one method of use, device  30  is introduced in a patient&#39;s stomach in the elongated, narrower configuration of  FIG. 1A , with apron member  40  oriented in the opposite direction to that shown in  FIG. 1A , that is, to cover tether  36  while the free end of distal portion  46  is oriented proximally, in the direction of second occluding member  34 . When in this configuration, device  30  is disposed within a tube (not shown) and is caused to exit the tube with proximal end  52  first, followed by the rest of the device. When device  30  has partially exited the tube (or alternatively, the tube has been retracted from device  30 ) so to leave apron member  40  outside of the tube, device  30  is pulled inside the tube, but because apron member  40  surrounds and wraps around the end of the tube, such a pulling of device  30  inwards into the tube, causing apron member  40  to flip over and change orientation, so to wrap around first occluding member  38 . After such a flipping around of apron member  40  has been achieved, device  30  is completely ejected from the tube and becomes disposed in the stomach. Alternatively, device  30  may be introduced in a patient&#39;s stomach with apron member  40  already oriented proximally, making unnecessary the previously described flipping operation. 
         [0055]    While the configuration of first occluding member  38  makes it recoil and assume the contracted configuration, similar to that shown in  FIG. 1B , the fully contracted, wider configuration of first occluding member  38  is achieved and maintained as follows. A connecting member  56  is coupled (for example, by a first string) to a release member  58 . A second string  60  is looped around device  30 , miming outside and along, device  30  starting from a first free end, and then extending within connecting member  56  through lumen  66 , and then (within a lumen or a tube) within turns  42 , successively entering a lumen  62  in tether  36  and second occluding member  34  (see also  FIGS. 1D and 1E ), and eventually exiting device  30  with a second free end. 
         [0056]    After device  30  has been introduced in the stomach, a clinician can hold both ends of second string  60  and, by pulling on second string  60  while device  30  is constrained within the stomach, the clinician causes connecting member  56  to travel in the direction of mating cavity  64 , shaped so to constrain connecting member  56  (for example, by interference fit) and to prevent connecting member  56  from being released. Therefore, first occluding member  38  is locked into its contracted, wider condition on a permanent basis. 
         [0057]    After device  30  has been shaped as described, second string  60  is removed by pulling on one free end and by having second string  60  slide through the lumens within device  30 , eventually exiting device  30  entirely. Device  30  is now free to move freely within the stomach, and the natural contractions of the stomach, in addition to any other movements of the patient&#39;s body, cause distal member  34  to move into the pylorus, while the size of proximal member  32  prevents it from moving into the pylorus and forces it to reside in the stomach. Therefore, distal member  34  will eventually be disposed in the pylorus, and any inserts of a heavier weight will facilitate retention of distal member  34  in the pylorus, while proximal member  32  will act as an intermittent plug against the pyloric valve, because stomach contractions and other body movements will cause proximal member  32  to move towards and away from the pyloric valve, acting as an intermittent plug and allowing the passage of some food from time to time. 
         [0058]    Another embodiment is illustrated in the cross-sectional side view of  FIG. 2A  and the top and bottom end views, respectively, of  FIGS. 2B and 2C . In this embodiment, device  31  may also include a distal member  33  connected or attached via tether  35  to proximal member  37 . As described above, proximal member  37  may comprise an apron member  39  which defines a curved or otherwise arcuate surface which tapers radially from tether  35  at a distal portion  41  (which typically contacts the stomach interior surface when in use) to a curved proximal portion  43  which has a relatively larger diameter and which may define a circumferential lip or edge  53  which is atraumatic to surrounding tissue. Apron member  39  may define a channel or interstice  45  within which first occluding member  47  may reside when occluding member  47  is in its contracted deployment configuration, as illustrated. With occluding member  47  contracted, apron member  47  may be configured to entirely or at least partially encircle or enclose occluding member  47 , as illustrated in  FIGS. 2D and 2E  which respectively show side and cross-sectional perspective views. Moreover, interstice  47  may be left open when in use in the patient body or an additional cap member or covering may be optionally attached to fully enclose apron member  39  and occluding member  47  within, if so desired. 
         [0059]    Occluding member  47  may be formed into a coiled or wound structure having a plurality of turns and a distal end which is attached, coupled, or otherwise formed integrally with device  31  at connecting portion  49 . Because of its coiled or wound helical structure, occluding member  47  may be extended in a low-profile configuration, as above, for delivery into the patient body and then allowed to compress or contract into its coiled structure which forms a diameter or cross-sectional area which is relatively larger than a diameter of distal member  33  to inhibit or prevent the passage of proximal member  37  through the pylorus when in use. As in the aforementioned embodiment, occluding member  47  may be biased or configured to self-contract. Alternatively, a string member or other locking mechanism, as described herein, may be actuated to compress and/or lock the structure such that the expanded configuration is maintained and prevented from releasing and reconfiguring back into its low-profile configuration. Distal member  33  may further define a lumen or channel  51  to facilitate the placement and/or positioning of device  31  within the patient body. 
         [0060]    In yet another embodiment, the occluding member may be fabricated as a separate component and attached or coupled within the apron member at a later time rather than forming the occluding member as a continuous integral component. This particular embodiment allows for the size and shape of the occluding member to be varied and altered according to any patient-specific parameters and attached within a common apron member. As shown in the side view of  FIG. 3A  and the cross-sectional side view of  FIG. 3B , occluding member  61  may be formed as a coiled or wound helical structure which defines a channel  65  and a receiving portion  63  when in its collapsed deployed configuration. As previously described, occluding member  61  may be advanced into the patient body in an extended low-profile configuration and then collapsed into its expanded and optionally locked configuration, as shown, either via actuation or by allowing for self-reconfiguration. 
         [0061]    Because the coiled portion of occluding member  61  may form a receiving portion  63  in its collapsed configuration, portion  63  may be coupled to a complementary securement mechanism positioned within apron member  37 . In this example, the securement mechanism may be comprised of a connecting portion  55  which extends distally within apron member  37 . Connecting portion  55  may have a securement member  57 , such as a tapered portion, and a stop member  59  which each limit the movement of portion  63  relative to connecting portion  55 . 
         [0062]    As illustrated in the cross-sectional side view of  FIG. 3C , occluding member  61  is shown in its collapsed and locked configuration while secured within interstice  45  and encircled by apron member  37 . As shown, securement member  57  may be advanced at least partially within channel  65  formed by the wound occluding member  61  to prevent the relative movement or release of occluding member  61  from connecting portion  55 . The connecting portion  55  is illustrated as an example and is not intended to be limiting. Other known securement mechanisms may be utilized as practicable. 
         [0063]    In these and other embodiments described herein, because the device may be introduced into the patient body in a minimally invasive manner, e.g., per-orally and through the esophagus into the patient&#39;s stomach, the device may be delivered in its low-profile configuration, e.g., were the occluding member is in its uncoiled or unwound elongate configuration. Alternatively, the device may be delivered in a partially locked configuration. Once within the stomach, for instance, the device may be coiled or wound into its deployment configuration and the occluding member may be affirmatively locked into position relative to the device such that its enlarged profile inhibits or prevents the passage of the device through the pylorus. In ensuring that the occluding member is locked into its expanded configuration, various mechanisms may be utilized to confirm its securement. 
         [0064]    One example includes having the string for locking the occluding member be color-coded such that one portion of the string is of a different color, e.g., red, than the remainder of the string. As the string is tensioned to lock the occluding member, once the color-coded portion is exposed from the device the user may visually confirm that the occluding member is locked into its deployment configuration. Alternatively, the amount of tension required to lock the device may be calibrated to increase to a preset level once the device is locked such that the user may confirm by tactile feedback that the device is indeed locked. 
         [0065]    Other alternative mechanisms for locking confirmation or detection of the occluding device may additionally include sensors incorporated within the device. An example is illustrated in the cross-sectional side view of  FIG. 1F , which shows sensor  67  positioned within the device. Sensor  67  may incorporate any number of detection modalities, e.g., acoustic, ultrasonic, electrical, electromagnetic, optical (for instance, detecting changes in color, wavelength, frequency, etc.), chemical, etc. which may sense changes in the occluding member from its coiled deployment configuration or changes in the string tension, connecting member  56 , or release member  58 . 
         [0066]    Based on the foregoing, device  30  (and variations thereof) assists in the treatment of obesity by limiting the passage of food from the stomach into the intestine, and at the same time by reducing the intake of food by the patient due to the sense of fullness generated by the retention of food in the stomach for a longer time and also by to the presence of device  30  in the stomach 
         [0067]    In yet another variation of the helically coiled device,  FIGS. 4A and 4B  show perspective views of a helical assembly  70  having a proximal member  72  reconfigured from its elongated configuration into its enlarged, coiled and nested configuration. The tether  74  may be seen extending from a compliant region  78  near a distal end of the proximal member  72  and a distal member  76  attached at a distal end of the tether  74 . The compliant region  78  may be provided with a variable stiffness to be more benign to the contacted tissue and to further prevent trauma to the surrounding tissue. In this and any of the variations herein, various coatings may be applied to the device, for example, for coefficient of friction, lubricity, enhanced biochemical durability, anti-microbial performance, etc. 
         [0068]      FIG. 4B  shows a cross-sectional side view of the coiled and locked assembly  70  which in this variation illustrates the elongate coiled member  80  having a contoured profile  84 . The profile  84  may define a projecting portion which may form a contact interface  82  when coiled into its nesting configuration with the adjacent coil although reversed contours may also he used to prevent the inward displacement of the nested loops. The contoured profile  84  may also enhance alignment of the structure during deployment as well. Furthermore, the edges of the coiled member  80  may also be radiused to reduce exposure of any edges to the gastric tissue. Once nested, the coiled member  80  may form a compacted shape which may form an enclosed space  88  within and which may be configured into a spherically-shaped structure, as shown. To maintain its compacted configuration, a central column  86  may extend through the center of the proximal member  72  to lock the shape of the member  72 . The central column  86  may be formed in part by a distal hub  90  which may be anchored or attached at a distal end of the proximal member  72  and also optionally attached to the hub where the tether  74  is attached to the proximal member  72 . A proximal plug  94  may be seated  96  at a proximal end of the coiled member  80  and extend into an coupled attachment to the distal hub  90  which may be connected via, e.g., a collar  92  such as a directional C-clip, etc. 
         [0069]    Optionally, a reinforcing member  98  such as a wire or suture length may be coupled to the distal hub  90  and extend through the tether  74  into attachment with the distal member  76 . Additionally, a distal weight  100  may also be optionally integrated in the distal member  76  as well. The inclusion of a reinforcing member  98  may prevent the over-extension of the tether  74  during deployment and use. The member  98  may also function to prevent the detachment of the tether  74  or distal member  76  in the unlikely event that the tether  74  fails. 
         [0070]      FIGS. 5A and 5B  show cross-sectional side and perspective views of the proximal member  72  to illustrate detail features for locking the proximal member  72  into its enlarged and compacted configuration. As shown, the proximal plug  94  may include a release mechanism  110  which extends through a proximal end of the plug  94  and is secured via one or more release securement members  112  within the plug  94 . The release mechanism  110  may be toggled proximally and distally relative to the plug  94  to selectively lock or unlock one or more tensioning wires which extend transversely through the coiled member  80 . Moreover, the release mechanism  110  may be formed to have a rigid lip to facilitate its grasping by endoscopic tools when locking or unlocking the mechanism  110 . Optionally, the release mechanism  110  may also integrated a valve, such as a duck-billed valve, to prevent solid matter from entering the internal space of the proximal member  72 . The collar  92  may also be seen coupling the distal hub  90  and the proximal plug  94  to one another. As the coiled member  80  configures into the enlarged configuration, the plug  94  may come into it mating engagement with the distal hub  90  which may then be joined by the collar  92  housed around the proximal plug  94 . 
         [0071]    To facilitate the reconfiguration of the coiled member  80  into its compacted configuration and to lock its enlarged configuration in a secure manner, one or more tensioning wires may extend through the coiled member  80  in a transverse direction. The tensioning wires may be formed of various wires or other high-strength force fibers. The terminal end of the coiled member  80  may integrate one or more tensioning wire pins  114 ,  116 , as shown in  FIG. 5A , to which one or more corresponding collets  120 ,  122 ,  124  are attached and which also have corresponding lock lines  126 ,  128 ,  130  extending from their respective pins. The lock lines  126 ,  128 ,  130  may be located uniformly about the circumference of the proximal member and extend transversely through respective lumens defined through the coiled member  80 , as shown in  FIG. 5B . Although three lock lines are shown, this is done for illustrative purposes and any number of lock lines may be utilized at uniform (e.g., four lock lines positioned at 90 degrees relative to one another about a circumference of the proximal member  72 ) or arbitrary locations around the proximal member  72 . Moreover, multiple lock lines may further provide for locking redundancy such that if one lock line were to fail, the proximal member  72  may still retain its enlarged structure. 
         [0072]    With the lock lines extending through the coiled member, they may pass and loop through corresponding openings  132  located near or at the proximal end of the proximal plug  94 . The remaining terminal ends of each of the lock lines may be passed externally of the assembly  70  as well as externally of the patient body when in use to facilitate the tensioning and securement of the lock lines when collapsing the proximal member  72 . With the looped lock lines passing through opening  132 , the release mechanism  110  may be selectively collapsed into the proximal plug  94  to lock the tensioning in the lock lines which may maintain the compacted configuration of the proximal member  72 . Pulling of the release mechanism  110  may accordingly release the lock lines and allow for the unraveling of the proximal member  72 , e.g., during removal of the device from the patient&#39;s stomach. 
         [0073]    To facilitate the tensioning of the lock lines, they may be engaged through the respective collets to allow for unidirectional passage of the lock lines. Thus, as the lock lines are tensioned through the collets, they may be pulled in only a tensioning direction to prevent or inhibit the unraveling of the proximal member  72 . Additionally, the collets or pins may be optionally radio-opaque to facilitate visualization of the device through, e.g., fluoroscopic visualization, to provide for confirmation of the locked status of the proximal member  72 . 
         [0074]    In yet another variation.  FIGS. 6A and 6B  show perspective and cross-sectional perspective views of a covered obstructing assembly  140 . In this variation, a covering  142  may enclose the coiled member  80  partially or completely such that the surface presented to the surrounding tissue remains completely smooth and uniform. The covering  142  may approximate the enlarged shape of the proximal member  72  such that the coiled member  80  may be formed entirely within the covering  142  itself, as described herein. Once the coiled member  80  has been formed within, a tissue interface  144  may be positioned by the terminal end of the coiled member  80  so as to present a smooth surface against the surrounding tissue. 
         [0075]    As shown in the cross-sectional perspective view of  FIG. 6B , a strain relief hub section  146  may be incorporated between the covering  142  and tether  74  so as to prevent the excessive strain at the connection point due to the softened structure. The strain relief hub section  146  may be internally expandable such that it is rotationally secure. It may also be provided as a single-molded pan that can be expanded by compression. An attachment collar  148 , in an alternative variation, may extend into the receiving space  152  defined within the covering  142  and the proximal plug,  94  may be detached from the distal hub  90  such that the central column is discontinuous. The attachment collar  148  may be configured to receive the pins at the terminal ends of the lock lines to lock the proximal member  72  in its configuration and may also join the member  72  to the covering  142 . Having a decoupled column may provide for additional flexibility to the proximal member  72  which may conform or flex to a greater extent. With the covering  142  deployed first, the coiled member  80  may be introduced in its elongate configuration directly through cover opening  150  and into the receiving, space  152  where it may coil into its nested and collapsed configuration, as described herein. 
         [0076]      FIG. 7  shows a perspective assembly view of the various components which may form the covered embodiment. As shown, the covering  142  may incorporate the distal hub  90  and attachment collar  148  within the receiving space  152 , as shown in the partial cross-section perspective view of  FIG. 8 . The coiled member  80  may be introduced into the receiving space  152  through opening  150  as a component separate from the covering  142 . As previously described, the proximal plug  94  and release mechanism  110  may also be integrated with the coiled member  80 . Additionally, a delivery tube  160  having a tapered covering interface  162  may be provided for attachment to the opening  150 . The delivery tube  160  may provide an access passage for the introduction of the coiled member  80  in its elongate form into the covering  142 . 
         [0077]      FIGS. 9A to 9C  illustrate partial cross-sectional perspective views of an example showing how the coiled member  80  may be deployed. With the covering  142  attached temporarily to the covering interface  162  at opening  150 , as shown in  FIG. 9A , the covering  142  may be positioned within the stomach.  FIG. 913  illustrates how the covering  142  may be devoid of the coiled member  80 . As shown in  FIG. 9C , the coiled member  80  may then be introduced through the delivery tube  160  and into the receiving space  152  where it may then coil into its nested and compacted configuration. Once complete, the covering interface  162  may be pulled from the opening  150  to detach itself and the tissue interface  144  and release mechanism  110  may obstruct or plug the covering opening  150 . 
         [0078]    In delivering and deploying the obstructing device into the stomach, one variation of a delivery assembly  170  is shown in the perspective view of  FIG. 10 . In this example, the assembly  170  may generally having a tensioning control assembly  172  attached to a delivery tube  184  extending, from the control assembly  172 . The coiled member  80  may be loaded within the delivery tube  184  in its elongated configuration with the tether  74  and distal member  76  positioned within the delivery tube  184  distal to the coiled member  80 . The lock lines may pass from the elongate member  80  within the delivery tube  184  and extend proximally through the delivery tube  184  and into the control assembly  172 . Each of the lock lines may be routed to a corresponding tensioning spring  174  which may provide a continual or intermittent tensioning force of variable magnitude upon the lock lines which may help to prevent the lock lines from tangling and which may also facilitate the tensioning of the lock lines when reconfiguring the coiled member  80  into its compacted shape. 
         [0079]    Each of the lock lines may also be attached to a corresponding tension control interface  178  which may tighten each of the lock lines individually or simultaneously, e.g., via an actuatable loop tensioner  176 . Each of the lock lines may be further routed through the control assembly  172  and into communication with a corresponding tensioning, wire access handle  180 . Once the proximal member  72  has been sufficiently nested and compacted, one or more of the wire access handles  180  may be pulled to expose the lock lines which may then be cut and/or removed from the assembly and patient. An optional insufflation port.  182  coupled to the delivery tube  184  may also be provided, e.g., for insufflating the stomach or body lumen prior to or during delivery of the obstructing member. 
         [0080]    When deployed, the obstructing device  70  may be placed within the stomach ST of a patient, as shown in the partial cross-sectional view of  FIG. 11A . The esophagus ES, pylorus PY, and duodenum DU are also illustrated for reference. With the proximal member  72  in its enlarged and nested configuration, the device  70  may lie within the stomach ST. Once the patient has ingested some food or liquid, the stomach ST may begin to contract such that the distal member  76  is moved through the stomach ST towards the pylorus PY. Because the distal member  76  is sized for passage through the pylorus PY, the distal member  76  may pass through to become positioned within the duodenum DU of the patient. However, because of the enlarged configuration, the proximal member  72  may remain within the stomach ST and cover the pylorus PY, as shown in  FIG. 11B . As the stomach continues to contract, the proximal member  72  may begin to intermittently obstruct and expose the pylorus PY allowing food and/or liquid to pass from the stomach at a slowed rate thus forcing the patient to feel full for longer periods of time. Once the stomach has been completely emptied, the device  70  may be allowed to then reposition itself within the stomach ST. 
         [0081]    In the event that the device  70  is to be removed from the patient, the device  70  may be collapsed within the stomach ST and removed back through the esophagus ES in its elongate configuration. One example is shown in the perspective view of  FIG. 12A  which illustrates how an optional access tube  190  may be positioned through the esophagus ES and an endoscope  192  or other instrument having, e.g., a grasper  194 , may be passed through the access tube  190  and into proximity to the proximal member  72 . The grasper  194  may be brought into contact with the release mechanism  110 , as shown in the perspective view of  FIG. 12B , which may then be pulled to unlock the proximal member  72 . The entire central column  86  may be removed from the proximal member  72 , as shown in  FIG. 12C , and removed from the stomach ST. With the proximal member  72  released, the coiled member  80  may be pulled through the access tube  190  and through the esophagus ES in its collapsed and elongate profile, as shown in  FIG. 12D . 
         [0082]    The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill, in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.