US20090024143A1 - Endoscopic implant system and method - Google Patents

Abstract

Disclosed is a system for endoscopically implanting a medical implant within a body cavity such as a human stomach. The system includes one or more anchors positionable within one or more openings formed in tissue within the body cavity, such as cutouts formed in plicated body tissue. Tools are disclosed for positioning the anchors within the openings, and for coupling the implant to the anchors.

Description

PRIORITY
• This is application claims priority to U.S. Provisional Application No. 60/950,584, filed Jul. 18, 2007, and U.S. Provisional Application No. 61/042,862, filed Apr. 7, 2008.
TECHNICAL FIELD OF THE INVENTION
• The present invention relates to the field of systems for use in endoscopically implanting devices within the gastrointestinal system.
BACKGROUND
• An anatomical view of a human stomach S and associated features is shown inFIG. 1. The esophagus E delivers food from the mouth to the proximal portion of the stomach S. The z-line or gastro-esophageal junction Z is the irregularly-shaped border between the thin tissue of the esophagus and the thicker tissue of the stomach wall. The gastro-esophageal junction region G is the region encompassing the distal portion of the esophagus E, the z-line, and the proximal portion of the stomach S.
• Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
• Several prior applications, including U.S. Publication No. US 2007/0276432 having a priority date of Oct. 8, 2004 and U.S. Publication No. US 2008/0065122, filed May 23, 2006 describe methods according to which medical implants are coupled to tissue structures, such as plications or folds, formed within the stomach. Examples of methods and devices for forming such tissue structures are described in U.S. Publication No. US 2007/0219571 (entitled ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S. application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser. No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS), filed Mar. 18, 2008. Each of the referenced publications and applications is incorporated herein by reference.
• As disclosed in these prior applications, more robust and long lasting coupling between the implant and the surrounding stomach wall tissue is achieved when the plications/folds are formed by retaining regions of serosal tissue (i.e., the tissue on the exterior surface of the stomach) in contact with one another. Over time, adhesions form between the opposed serosal layers. These adhesions help to create strong bonds that can facilitate retention of the plication/fold over extended durations, despite the forces imparted on them by stomach movement and implanted devices
• Several of the disclosed methods for forming tissue plications include a step in which a hole or cut is formed in the plication, using the plication device or other devices. An example of this type of plication is shown inFIG. 2A. This application discloses a system for attaching a medical implant to cutouts of this type, or to other types of openings in the plications (e.g., cuts, slits, perforations, tissue tunnels, etc.).
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic illustration of a human stomach and a portion of the small intestine.
• FIG. 2A is a partial section of a stomach wall showing a stomach wall plication having an opening formed in it.
• FIG. 2B is a cross-section view taken along the plane designated2B-2B inFIG. 1, and illustrating five plications formed in a gastro-esophageal junction region of the stomach.
• FIG. 3 shows an endoscopic implant system.
• FIG. 4A is a perspective view of the anchor of the implant system ofFIG. 3.
• FIG. 4B is a perspective view of the anchor ofFIG. 4A, showing the head separated from the stem.
• FIGS. 5-7 are partial section views of a human stomach schematically illustrating the anchor ofFIG. 4A positioned in an opening in a stomach wall plication.
• FIG. 8A is a perspective view of an anchor hand-off tool.
• FIGS. 8B and 8C are perspective views showing the anchor coupled to the anchor hand-off tool.
• FIG. 9A is a side elevation view of an anchor grasper in the open position.
• FIG. 9B shows the distal end of the anchor grasper ofFIG. 9A in the closed position.
• FIG. 10A is a top plan view of the anchor grasper ofFIG. 9A.
• FIG. 10B is a cross-section view taken along the plane designated10B-10B inFIG. 10A.
• FIGS. 11A and 11B are side elevation views of the distal end of an alternative anchor grasper.
• FIG. 12A shows a top perspective view of a first embodiment of a restrictor.
• FIG. 12B shows a side perspective view of a second embodiment of a restrictor.
• FIG. 12C shows a top perspective view of a third embodiment of a restrictor.
• FIG. 13 shows a top perspective view of a fourth embodiment of a restrictor.
• FIG. 14A shows a side perspective view of a fifth embodiment of a restrictor.
• FIG. 14B is a perspective view of the embodiment ofFIG. 14A, showing only the rib structure.
• FIG. 15A is a side elevation view of a restrictor guide.
• FIG. 15B is a cross-section view of the restrictor guide taken along the plane designated15B-15B inFIG. 15A.
• FIG. 16A is a perspective view of the distal portion of the restrictor guide, showing the mount in the open configuration.
• FIG. 16B is similar toFIG. 16A and shows the mount in the closed configuration.
• FIG. 16C is a cross-section view of the mount in the open configuration.
• FIG. 17A is a perspective view of a restrictor, showing the restrictor positioned on the restrictor guide, with the mount in the open configuration.
• FIG. 17B is similar toFIG. 17A but shows the mount in the closed configuration.
• FIG. 17C is a perspective showing the interior of a restrictor positioned on the restrictor guide.
• FIG. 18A is a perspective view showing the proximal end of the restrictor guide.
• FIG. 18B is a perspective view showing the distal portion of the multi-lumen portion of the restrictor guide.
• FIGS. 19A and 19B schematically illustrate elements of the system positioned in the stomach in preparation for transferring an anchor from an anchor hand-off to the anchor grasper that will then draw the anchor through the opening in the plication.
• FIGS. 20A-20F schematically illustrate transfer of the anchor from the anchor hand-off to the anchor grasper within the stomach.
• FIGS. 21A and 21B are perspective views showing the anchor grasper engaging different portions of the anchor head.
• FIGS. 22A-22C schematically illustrate a plurality of anchors that have been placed in plications in the stomach, together with elements of the disclosed system.
• FIG. 23 is a perspective view of the proximal end of the endogastric tube, showing use of the tool organizer.
• FIG. 24A is a perspective view of a restrictor being advanced onto proximal ends of a collection of anchor graspers.
• FIG. 24B is a perspective view similar toFIG. 24A showing the restrictor advanced further along the anchor graspers.
• FIG. 25A is a schematic illustration showing the downstream side of a restrictor within the stomach, anchored to plications using anchors.
• FIG. 25B is a schematic illustration showing the upstream side of a restrictor within the stomach, anchored to plications using anchors.
• FIGS. 26A-26D schematically illustrate use of the plicator for forming tissue plications and for forming holes in the plicated tissue.
DETAILED DESCRIPTION
• FIG. 2B is a schematic cross-section view of the stomach, looking distally into the stomach interior. In this view, five tissue plications P having openings such as cutouts C are shown to have been formed in the stomach wall tissue. This view would seem to illustrate clear access via the esophagus to the plications and cutouts using endoscopic instruments. However, the natural undulations and folds of the actual stomach tissue, and the constant movement of the stomach, limit the visibility of the cutouts and even the plications themselves, rendering it difficult to endoscopically access the cutouts in an actual human subject. The disclosed system facilitates access to the cutouts, and provides for an efficient method for coupling an implant to the cutouts.
• FIG. 3 illustrates an embodiment of anendoscopic implant system10 that may be used for this purpose. In general,system10 includes multiple anchors12 (one shown) that are implanted in the cutouts and animplant14 to be coupled to theanchors12. The implant can be any type of implant to be anchored within the stomach. In the disclosed embodiment, the implant is a restrictor14 designed to slow the rate at which food can enter the stomach from the esophagus.
• An anchor hand-off16 delivers the anchors into the stomach, and anchor graspers18 (one shown) are used to position the anchors within the tissue openings and also to guide the restrictor14 to the implanted anchors. Arestrictor guide20 is provided for advancing the restrictor into position in the stomach. An endogastric overtube22 is provided for establishing a working channel between the mouth and the stomach. Other tools shown elsewhere in the drawings, such as a multi-lumen guide24 (FIG. 19A), articulated guides25 (FIG. 19A), and one or more endoscopes26 (FIG. 19A) are additionally provided.
Anchor
• One embodiment of ananchor12 is shown inFIG. 4. A preferred anchor will pass though the opening C in the plication cutout with relative ease and minimal tissue trauma, but will resist pulling out of the opening in the cutout when subjected to the stresses imparted to it by the restrictor. Moreover, a preferred anchor will minimize the stress and strain on the stomach wall and distribute a given stress as evenly as possible so as to prevent the stomach's natural defense from engaging in an attempt to eliminate the anchors and restrictor.
• Referring toFIG. 4A, the general features of theanchor12 include abase28, astem30, and ahead32. The anchor is formed using materials that are durable within the stomach environment. In one embodiment, thehead32 is molded out of a higher durometer compliant material (such as 50 shore A durometer Silicone) while thestem30 andbase28 are molded out of a softer compliant material (such as 5 shore A durometer Silicone). Since the loading on the anchor from the restrictor implant can be seen as shear against the edges of the opening in the plication, thestem30 is formed to have a relatively large diameter (2 mm-8 mm) to minimize stress and abrasion on the stomach wall tissue inside the opening. The edges of the anchor are molded with generous fillet radii to minimize abrasion of stomach wall tissue.
• Head32 includes aring34 and a plurality ofstruts36 coupling thering34 to thestem30, and anelongate loop38 extending from thering34. The anchor is elastically deformable to an elongated shape (seeFIGS. 20D and 20E) in response to application of tension to thering34 or loop38 (collectively referred to as the “rim”). This allows the anchor to be drawn into a streamlined shape so that it can be drawn through the opening in the plication and also through an opening in the restrictor. When the anchor is pulled from the rim, its shape lengthens and slims down to fit through a much smaller hole. For example in one embodiment, in its natural state the anchor has an outer head diameter of approximately 0.600 inch (15 mm), but in its streamlined orientation it can fit through a plication opening of 0.200 inch (5 mm). However, once implanted, the anchor's shape resists pull-out force to a higher degree since the rim is not being pulled and lengthened directly. Also in this embodiment, the base is designed so it will not pull through the hole and may have an outer diameter of approximately 1 inch (25.4 mm)
• Referring to the top view of theanchor12 shown inFIG. 5, when an anchor is implanted in a plication opening, the anchor's proximity to the wall of the stomach with its enveloping rugae can make it difficult to find and grab onto the anchor when it is time to couple the restrictor implant to the anchors. Thehead32 is shaped to have an undulating profile to enhance its visibility and accessibility when the anchor is positioned in a plication opening. The undulation of the head forces several of the elements of the head away from the wall to make them more visible and also to allow a grasping tool to latch onto one of those elements without also grabbing adjacent tissue.
• Referring toFIG. 6, thebase28 is preferably formed to have an asymmetrical shape. In the illustrated example, oneedge40 of the base is formed to have a flatter curvature than that of theother edge42 of the base. When implanted, the anchor self-orients to position theflatter edge40 against the adjacent stomach wall as shown. Since theloop38 of the head extends in a direction opposite to the side of the anchor on which theflatter edge40 is position, this self-alignment causes theloop38 to extend towards the center of the stomach as shown inFIG. 7. This makes it easier to find segments of the anchor head amongst the folds of the stomach which can envelope other segments.
• Referring again toFIG. 6, the base28 preferably includes a relatively large surface area (e.g., approximately 1 square inch) so as to distribute the stress of holding the restrictive implant in place over a large percentage of the surface area of the tissue plication. Reinforcingribs44 may be positioned on the underside of the base, radiating from the stem to the edges of the base, to facilitate distribution of stress while minimizing the overall weight of the base.
Anchor Hand-Off Tool
• Anchor hand-off16 is an instrument used to deliver individual anchors to the implantation site, and to hand-off each anchor to an anchor grasper which pulls the anchor through an opening in a plication.
• Referring toFIG. 8A, one embodiment of an anchor hand-off18 includes a torqueableelongate shaft46 having awire element48 extending from its distal end and attachable to an anchor.
• In one embodiment, the anchor hand-off16 has a horseshoe shaped form with anopening45 that narrows to form aconstriction47. The stretchable nature of the anchor stem30 allows it to be squeezed through theconstriction47 and thus held in place by friction. SeeFIGS. 8B-8D. Upon pulling on thehead portion32 by the anchor grasper,18, thestem30 elongates and passes out of the horseshoe shaped constriction.
• Shaft46 is slidably disposed in an articulating guide49 that will articulate in response to actuation using pull wires or other means known to those skilled in the art. The articulatingguide26 may be one with video capability, for example it might be an articulating endoscope. In one embodiment,wire element48 is detachable from theshaft46 of the anchor hand-off16 to allowshaft48 to pass through a small diameter tool channel in the articulatingguide26. Once the distal end of theshaft46 reaches the distal end of theguide26, thewire element48 is coupled to theshaft46.
• Furthermore, the anchor hand-off tool16 may be designed to hold the anchor behind (or axially off-set from) the distal tip of the articulatingguide26 with video capability. This facilitates greater visibility at the target site/plication by positioning the held anchor out of the endoscope's field of view as shown inFIGS. 8C and 8D. To perform the actual hand-off of theanchor12, the user can extend and torque the hand-off tool16 to position at least a portion of theanchor head32 within the field of view.
Anchor Grasper Tool
• Anchor grasper18 is designed to couple to or engage a portion of thehead32 of ananchor12. It is used to pull theanchor12 through an opening in a plication, and to pull the anchor through a corresponding opening in a restrictor that is to be implanted. Theanchor grasper18 may have a variety of designs that allow these functions to be carried out. One such design is shown inFIGS. 9A and 9B an employs a coupling/graspingelement50 that takes the form of ahook52 having agate54 that closes against the opening in thehook52. The hook and gate are naturally biased in the open position shown inFIG. 9A.
• Aclosure tube56 is longitudinally slidable over the hook and gate to lock them in the closed position, thus preventing them from separating. The collar and associated features are proportioned to ensure that when the graspingelement50 is to be locked, bending of the shaft of theanchor grasper18 does not cause theclosure tube56 to slide into a position that will release the graspingelement50 from the locked position.
• Referring toFIG. 10B, theclosure tube56 is mounted to a torqueable element58 (preferably a coil), which in turn is coupled toouter tubing60. An L-shapedslot62 is formed in theouter tubing60. As best shown inFIG. 10A,slot62 includes alongitudinal segment63aand a partiallycircumferential segment63b.
• Hypotube64 is slidably and rotatably disposed withinouter tubing60, and includes apin66 disposed within theslot62.Hypotube64 is mounted to a taperedhandle68. A cable70 has a distal end coupled to the graspingelement50 and a proximal end mounted to thehandle68.
• To close and lock the grasping element, theouter tube60 is advanced distally relative to thehandle68. Advancement of theouter tube60 pushes thecoil58 and thus theclosure tube56 in a distal position until theclosure tube56 moves the graspingelement50 to the closed position shown inFIG. 9B. As theouter tube60 moves distally,longitudinal segment63aof theslot62 slides overpin66. Theouter tube60 is then rotated to cause positioning ofpin66 within thecircumferential segment63bof theslot62, and to thereby lock theouter tube60 in the distal position. To unlock thegrasper element50, theouter tube60 is rotated in the opposite direction to release thepin66 from thecircumferential segment63b. Since the closure tube is no longer locked in the distal position, the graspingelement50 moves to the open position due to its natural bias, thereby pushing theouter tube60 in a proximal direction.
• FIGS. 11A and 11B show an alternative grasper element50awhich is moved between open and closed positions using a system72 of linkages pivoted using a longitudinally slidable push rod74.
Restrictor
• The restrictor is an implant designed to slow the passage of food from the esophagus into the stomach. The illustrated embodiments, the restrictor is positioned in the stomach such that food enters the restrictor through a proximal opening and exits the restrictor through a distal opening. The restrictor and/or openings are proportioned to slow the rate at which food can move into or through the restrictor, and/or from the restrictor into the rest of the stomach.
• A preferred restrictor is proportioned to be coupled to anchors that have been coupled to plications in the gastroesophageal junction region of the proximal stomach. In a preferred design, therestrictor14 includes features that minimize pulling against the anchors when the restrictor encounters stress as a result of food moving through the restrictor and/or movement of the stomach. Minimizing pulling at the anchors is beneficial for minimizing stress on the stomach wall tissue coupled to the anchors. In general, therestrictor14 is designed to have compliance between the anchor points (i.e., the points at which the implant is coupled to the tissue directly or using the anchors). This compliance may be achieved using the geometry of the restrictor14 and/or using restrictor materials selected to give compliance between anchor points.
• In a first embodiment shown inFIG. 12A, therestrictor14 is a sleeve having a wall and a plurality ofanchor openings80 formed in the wall. The restrictor wall is an undulating wall definingmultiple folds76 that give it compliance even when molded from a relatively more stiff material (such as 30 shore A silicone). When viewed from the side (see thesecond embodiment14ainFIG. 12B), it can be seen that the proximal edge of the restrictor14 undulates to definepeaks78 in the profile of the proximal edge. When viewed from the top (FIG. 12A), it can be seen that the circumferential profile of the restrictor also includespeaks82 extending radially outwardly. Thesepeaks82 definechutes84 extending from theproximal peaks78 towards adistal orifice86. When the restrictor is implanted, thechutes84 help to channel ingested material towards thedistal orifice86.
• Anchor openings80 are positioned between the radial peaks82. These openings may be positioned in the portion of the wall that is at the most radially inward position as on the restrictor14aofFIG. 12B, or the undulations in the wall may be such that theopenings80 are in a section of wall that is positioned between some inwardly extendingfolds88 as inFIG. 12A (or that, in other words, forms smallerradial peaks90 than the radial peaks82).
• Openings80 may be surrounded by reinforcedsections92 formed using thicker regions of silicone, or a stronger material embedded in or attached to the silicone. Additional reinforcements such asribs94a,94bmay extend from theopenings80 towards theorifice86 and/or from theproximal peaks78 towards theorifice86 and may be formed using similar techniques.
• The edge of the wall defining theorifice86 preferably includes folds orundulations96, allowing the orifice to be compliant as well. In addition,small holes98 are arranged around the orifice to allow the restrictor14 to be coupled to the restrictor guide used to deliver the restrictor into the stomach.
• Analternative restrictor14bshown inFIG. 12C is similar to the restrictor ofFIG. 12A, but is molded to be flat for ease of manufacturing, but assumes its undulating configuration at the folds when coupled to anchors atanchor openings80.
• Yet anotheralternative restrictor14c(FIG. 13) is molded out of highly compliant material (such as 40 shore 00 silicone) to put minimal stress on attached stomach tissue. This embodiment includes a reinforcedproximal rim100.
• Anadditional restrictor14dis molded out of a combination of high and low compliance material (such as 50 shore A plus 40 shore 00 silicones) in different areas of the restrictor to achieve optimal performance. Arib structure94c(seeFIG. 14B) out of stiffer material serves to maintain the restrictor shape in the open position within the stomach. IN this example,rib structure94cincludes an undulating ring94dencircling theorifice86, andribs94eextending topeaks78. In this manner, therib structure94cmaintains apposition of the restrictor against the wall of the stomach in order to improve the effectiveness of catching food, particularly in thechutes84. In addition to the stiffer rib structure, the assembled restrictor contains a verysoft web95 of material that forms the funnel shape and also serves to link together the anchor points80 (seeFIG. 14A). The soft compliant nature of the web material minimizes the stress to the plication tissue by allowing full flexibility.
Restrictor Guide Tool
• Restrictor guide20 generally includes a tubular shaft101, a distal portion comprising a coupling element/mount102 and aproximal portion104.
• In a preferred restrictor guide, themount102 is designed to support the restrictor14 during delivery of the restrictor into the stomach and coupling of the restrictor12 to the stomach wall (directly or using anchors or other means as disclosed herein). In the illustrated embodiment, mount102 includes acollar103 on the distal end of the shaft101. A pair oftubes112 extend distally between thecollar103 and aring107.Ring107 includes a plurality of distally extendingpins106 and acentral opening109. Atube111 is positioned co-axially with theopening109. Adistal cap108 is mounted to the distal end of thetube111.Cap108 includes an opening positioned in alignment with the opening of thering107 and the lumen of thetube111.Bores110 in the cap are positioned so that proximal advancement of thecap108 relative to thering107 causespins106 to enter thebores110.
• Referring toFIG. 17A, pins106 are arranged to allow a user to couple the restrictor14 to the restrictor mount by threading theholes98 surrounding the orifice in the restrictor14 over thepins106 as shown. When the restrictor14 is mounted in this way, thetube111 is disposed in theorifice86 of the restrictor, and thecap108 is positioned distal to the restrictor.Restrictor14 is retained on themount102 by moving thecap108 in a proximal direction untilbores110 slide over thepins106, thus capturing the restrictor14 between thecap108 and thering107 by preventing the restrictor from sliding off the pins. SeeFIG. 17B.
• Driverods112a(FIG. 16A) extend through thetubes112 and are coupled at their distal ends toflanges120 on the proximal end oftube111. The proximal ends of thedrive rods112aare advanceable by an actuator at the proximal end of the restrictor guide. Manipulation of the actuator will cause thedrive rods112ato move distally relative to thetubes112, causing distal movement of thecap108 relative to thering107. In one current embodiment, rotation of a threaded nut on the proximal handle moves a threaded piece inside the handle that is connected to wires or cables that communicate with thedrive rods112a. In another embodiment, thedrive rods112amay be lead screws, and the actuator may include a knob and associated gearing for rotating the lead screws such that they advance thecap108 distally. Alternatively, the actuator may include a spring that is initially locked in a compressed position using a latch. According to this embodiment, a button or other element is manipulated by the user to disengage the latch, thus releasing the spring from the compressed position to drive the drive rods distally. Other alternatives include pneumatic or hydraulic actuation of thecap108. In other embodiments, the actuator may be a handle that allows the user to manually advance the drive rods to advance the cap.
• Proximal portion104 of therestrictor guide20 is a multi-lumen guide having acentral lumen114 through which the tubular shaft101 extends, and a plurality ofperipheral lumens116 arranged around the central lumen. Theperipheral lumens116 are proportioned to accommodate theanchor graspers18. Each of theperipheral lumens116 has a proximal port fitted with a seal (which may be, for example, a duck bill seal) that will seal around the shaft of agrasper18 positioned in the lumen, and that will self-seal when thegrasper18 is removed from the lumen.
Exemplary Procedure
• Use of thesystem10 to implant a restrictor14 will next be described. According to one embodiment, the method is performed following an initial procedure in which a plurality of plications P having cutouts or other openings C are formed. In another embodiment, after each plication is formed, ananchor12 is implanted in that plication's opening for the dual purpose of marking the location of the plication as well as ensuring that the opening does not close in the natural healing process of the tissue. The anchor implantation procedure may immediately precede restrictor implantation, or may instead be performed in advance of the restrictor implantation procedure to allow reinforcement of the plications through the body's healing process.
• In the initial phase of the restrictor implantation procedure, anchors12 are positioned in the openings of the plications P. Referring toFIG. 19A, theendogastric tube22 is introduced into the mouth and through the esophagus, and parked with its distal opening in a portion of the stomach or esophagus that is proximal to the plications P. After each plication with opening is created, a multi-lumen (or cannulation) guide tube24 may be passed through theendogastric tube22. Multi-lumen guide tube24 may have a central lumen24aand peripheral lumen24bin a similar arrangement to the lumen of the restrictor guide20 (FIG. 18B).
• Outside the body, an anchor hand-off16 is passed through a tool channel of anendoscope26 such that theanchor engaging wire48 extends from the endoscope lumen. With the engaging wire in this position, ananchor12 is coupled to theengaging wire48, and theendoscope26, anchor hand-off16, andanchor12 are together passed through the central lumen24aof the multi-lumen guide tube24 and into the stomach as shown inFIGS. 19A and 19B. Theendoscope26 is retroflexed within the stomach to provide visualization of the plication P.
• Next, an articulatingguide25 is advanced through a peripheral lumen24bof the multi-lumen guide tube24 and into the stomach. Ananchor grasper18 is positioned in the lumen of theguide25. Under visualization using endoscope26 (with anchor hand-off18 retracted so that the anchor is out of view), guide25 is articulated to orient thegrasper18 towards the opening C in the plication, and thegrasper18 is then advanced through the opening as also shown inFIGS. 19A and 19B. The graspingelement50 of thegrasper18 is moved into the open position.
• Referring toFIGS. 20A,20B and20C, anchor hand-off16 is advanced further from theendoscope26 until thehead32 of the anchor is positioned within reach of the graspingelement50. Graspingelement50 is manipulated to engage thehead32. While it is preferable to engage theloop38 as shown inFIG. 21A, the structure of thehead32 allows for engagement of other portions of the head such as thestruts36 as shown inFIG. 21B, or the ring surrounding thestruts36. Engagement between the anchor and the anchor grasper is secured by moving the graspingelement50 into the locked position. Next, the anchor hand-off is retracted into the endoscope in order to separate it from the anchor grasper. This action results in stretching the anchor stem and thus causing it to release from the horseshoe shaped form. SeeFIG. 20D. The handle of theanchor grasper18 is then withdrawn to pull thehead32 of the anchor through the opening C in the plication as inFIG. 20E. As discussed above, application of tension to thehead32 causes the anchor to elongate to a narrow profile that will pass readily through the opening C in the plication. The jaws of theanchor grasper18 are opened to release theanchor12.FIG. 20F.
• Theendoscope26 and anchor hand-off16 are withdrawn from the guide tube24 along with the multiple lumen guide and articulating guide. After another plication is created, the process is repeated for each anchor that is to be implanted. SeeFIGS. 22A-22C.
• As each anchor is implanted, its corresponding anchor grasper is preferably left coupled to the ring of the anchor, although it may instead be withdrawn from the body. At the end of the anchor-positioning phase of the procedure, each anchor is positioned extending through a plication opening (FIG. 22A). If the anchor graspers were left in place coupled to the rings of each anchor, the handles of eachseparate anchor grasper18 extend out of the body. Organization of theanchor graspers18 is maintained by the multi-lumen cannula24.
• If theanchor graspers18 are not left in place following implantation of the individual anchors12, thegraspers18 are re-coupled to the anchors prior to the restrictor-positioning phase. Specifically, each of thegraspers18 is reintroduced into the stomach and endoscopically guided by its corresponding articulatedguide25 into engagement with thehead32 of one of the anchors. As discussed in the Anchors section above, orientation of theloop38 to extend in a direction opposite to theasymmetrical base28 helps to orient theloop38 centrally within the stomach so that theloops38 may be more easily seen and engaged by thegraspers18.
• The restrictor-positioning phase of implantation begins with each anchor that is to be coupled to the restrictor having aseparate anchor grasper18 coupled to it. If the multi-lumen guide24 is still in use at this point, with individual ones of thegraspers18 in the peripheral lumen24b, the guide24 is withdrawn from theendogastric tube22 and removed from the handles of the anchor graspers. The tapered proximal ends of theanchor graspers18 allow the lumens24bof the guide24 to pass easily over them. Before the multiple lumen guide is completely removed from theendogastric tube22, the anchor grasper tool shafts are locked into atool organizer130 at the proximal end of theendogastric tube22 as shown inFIG. 23.Organizer130 includes slots132 positioned to receive the shafts of thegraspers18, leaving them arranged around themain lumen134 of the endogastric tube. This serves to maintain the relative clocking of each grasper at the proximal end to a corresponding anchor location at the distal end.
• The restrictor14 is prepared for implantation by threadinganchor openings80 in the restrictor over the tapered proximal ends of theanchor graspers18, which at this point are still extending out of theendogastric tube22.FIG. 24A. The restrictor14 is mounted to themount102 of therestrictor guide20 in the manner disclosed in the Restrictor Guide section above. This step may be performed before or after the restrictor is threaded over the anchor graspers.
• Next, therestrictor guide20 is advanced over the tapered proximal ends of theanchor graspers18, which are still extending out of theendogastric tube22. Therestrictor guide20 is positioned so that each of itsperipheral lumens116 advances over a separate one of theanchor graspers18.FIG. 24B. Continued distal advancement of theguide20 advances theguide20 andrestrictor14 through theendogastric tube22 and into the stomach.
• In a final step, theanchors12 are pulled through theanchor openings80 to couple the restrictor14 to theanchors12. In this step, distally-oriented pressure is applied to therestrictor guide20 while theanchor graspers18 are one-by-one pulled proximally, causing theanchors12 to elongate sufficiently to pass through theopenings90. Coupling between each anchor and its correspondingopening80 is confirmed visually and/or by tactile feedback reflecting the “pop” of the anchor moving through theopening80. Once therestrictor14 has been coupled to theanchors12, thecap108 of therestrictor guide20 is advanced distally to release the restrictor as described in the Restrictor Guide section above. The anchor graspers18 are unlocked and separated from the anchors. Therestrictor guide20,anchor graspers18, guides, etc. are withdrawn from the body, leaving the restrictor14 and anchors12 in place as shown inFIGS. 25A and 25B.
• The system ofFIG. 3 may additionally include one or more tools for use in forming plications in the stomach wall tissue and for forming holes in the plicated tissue. Examples of such plicators are found in the following co-pending U.S. patent applications: U.S. Publication No. US 2007/0219571 (entitled ENDOSCOPIC PLICATION DEVICES AND METHOD), filed Oct. 3, 2006, U.S. application Ser. No. 11/900,757 (entitled ENDOSCOPIC PLICATION DEVICE AND METHOD), filed Sep. 13, 2007, and U.S. application Ser. No. 12/050,169 (entitled ENDOSCOPIC STAPLING DEVICES AND METHODS), filed Mar. 18, 2008.
• Use of one such tool is generally illustrated inFIGS. 26A-26D and includes drawing stomach wall tissue into a vacuum chamber of a plication head (FIG. 26A), compressing the tissue (FIG. 26B), advancing fasteners such as staples through the compressed tissue and forming a cut or hole in the compressed tissue (FIG. 26C), and releasing the tissue from the plication tool, leaving the plication with a hole or cut out through the plicated tissue. In one staple arrangement, a pair of annular staple patterns encircle the cut/hole. Anchors can be subsequently positioned within the hole/cutout as disclosed above.
• Although the disclosed system has been described in the context of implanting a restrictor implants implantable in the stomach for limiting limit intake of food by the patient, the systems and methods may be used to implant other types of implants for a variety of purposes. These implants include, but are not limited to obstructive gastric implants that obstruct flow of food into the stomach, gastric space occupiers for limiting effective stomach volume, prosthetic valves for the treatment of gastro-esophageal reflux disease, gastric stimulators, pH monitors and drug eluting devices that release drugs, biologics or cells into the stomach or elsewhere in the GI tract. Such drug eluting devices might include those which release leptin (a hormone which creates feelings of satiety), Ghrelin (a hormone which creates feelings of hunger), octreotide (which reduces Ghrelin levels and thus reduces hunger), Insulin, chemotherapeutic agents, natural biologics (e.g., growth factor, cytokines) which aid in post surgery trauma, ulcers, lacerations, etc. Still other implants might be of a type which might provide a platform to which specific cell types can adhere, grow and provide biologically-active gene products to the GI tract, and/or a platform for radiation sources that can provide a local source of radiation for therapeutic purposes, or provide a platform whereby diagnostic ligands are immobilized and used to sample the GI tract for evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract via cameras and other image collecting devices. Additionally, the disclosed anchors and restrictors are shown positioned and anchored near the gastro-esophageal junction region of the proximal stomach, but may be positioned and/or anchored elsewhere in the stomach or GI system.
• It should also be recognized that a number of variations of the above-identified embodiments will be obvious to one of ordinary skill in the art in view of the foregoing description. Accordingly, the invention is not to be limited by those specific embodiments and methods of the present invention shown and described herein. Rather, the scope of the invention is to be defined by the following claims and their equivalents.
• Any and all patents and patent applications referred to herein, including for purposes of priority, are incorporated herein by reference.

Claims (61)

1. A method of coupling an implant to tissue having an opening formed therein, the method comprising:

providing an anchor having a head and a base;

drawing the head through the opening in the tissue to position the head on a first side of the plication and the base on a second side of the plication, and

coupling an implant to the anchor.

2. The method ofclaim 1, wherein the method includes, after drawing the head through the opening, expanding the head to a diameter larger than the diameter of the opening.

3. The method ofclaim 1, wherein drawing the head deforms the head for passage through the opening, an wherein expanding the head includes allowing the head to assume the larger diameter.

4. The method ofclaim 2, wherein the method includes:

coupling the anchor to a first tool;

advancing the first tool into a body cavity;

advancing a second tool into the body cavity and passing the second tool through the opening;

after passing the second tool through the opening, engaging the anchor using the second tool;

withdrawing the second tool from the opening to draw the head through the opening; and

releasing the anchor from the first tool.

5. The method ofclaim 4, wherein coupling the implant to the anchor includes passing the implant over the second tool and over the head.

6. The method ofclaim 2, wherein the method includes coupling a tool to the head, and wherein coupling an implant to the anchor includes, with the tool coupled to the head and with a portion of the anchor disposed in the tissue opening, advancing the implant over the tool and into engagement with the anchor.

7. The method ofclaim 6, wherein the implant includes an opening, and wherein advancing the implant over the tool and into engagement with the anchor includes threading the opening of the implant onto the tool and advancing the implant over the tool and the head.

8. The method ofclaim 1, wherein coupling the implant to the anchor includes coupling the implant to the anchor after drawing the head through the tissue opening.

9. The method ofclaim 4, wherein advancing the first tool into the body cavity includes advancing the first tool with the anchor thereon into the body cavity.

10. The method ofclaim 4, wherein the anchor is coupled to the first tool after the first tool is advanced into the body cavity.

11. The method ofclaim 7, wherein the method includes providing a plurality of the anchors and drawing the heads of the plurality of the anchors through a plurality of tissue openings, coupling a plurality of tools to the heads of the plurality of anchors, and advancing the implant over the plurality of tools and into engagement with the anchors.

12. The method ofclaim 6, wherein the tissue opening is in a plication extending from a tissue wall and wherein:

providing the anchor includes providing the head to include a laterally-extending loop

the method further includes positioning the anchor within the tissue opening such that the loop extends generally away from the most proximate second of the tissue wall.

13. The method ofclaim 12, wherein:

providing the anchor further includes providing the base to include a first edge having a first curvature and a second edge having a second, flatter curvature, the loop extending laterally in a direction opposite to the second edge of the base, and

positioning the anchor includes positioning the anchor with the second edge in contact with the wall to cause the loop to extend generally away from the most proximate section of the tissue wall.

14. The method ofclaim 12, wherein the tissue opening is in a plication in a stomach wall, and wherein positioning the anchor includes transorally introducing the anchor into the stomach and positioning the anchor with the second edge in contact with the interior wall of the stomach.

15. The method ofclaim 1, wherein the tissue opening is in a plication in a stomach wall, and wherein the method includes introducing the anchor and the implant transorally into the stomach.

16. The method ofclaim 15, wherein the method is further for forming the opening in the tissue structure, and further includes:

forming a plication in the wall of the stomach;

forming an opening in the plication.

17. The method ofclaim 16, wherein the method includes introducing a plication tool transorally into the stomach and forming the plication with the plication tool.

18. The method ofclaim 17, wherein the method includes forming the opening in the plication with the plication tool.

19. A medical implant system for coupling an implant to an opening formed in body tissue, comprising:

an anchor comprising a head coupled to a base, the head having a first, natural, position in which the head has a diameter larger than a diameter of the opening, and a second, elongated, position in which the head is deformed for passage through the opening; and

an implant having an opening, the opening of the implant proportioned to allow passage of the head when the head is in the second position, and to resist passage of the head when the head is in the first position.

20. The medical implant system ofclaim 19, wherein the anchor head is moveable from the first position to the second position in response to application of tension in a generally longitudinal direction between the head and the base.

21. The medical implant system ofclaim 19, wherein the anchor head is moveable to a third position in response to application of tension to the head in a generally transverse direction, wherein in the third position the head is proportioned to resist passage through the opening.

22. The medical implant system ofclaim 19, wherein the head is more elastic than the base.

23. The medical implant system ofclaim 19, wherein the anchor includes a stem extending between the head and the base.

24. The medical implant system ofclaim 23, wherein the stem is more elastic than the base.

25. The medical implant ofclaim 23, wherein the head includes a ring coupled to the stem.

26. The medical implant system ofclaim 25, wherein the ring has an undulating surface.

27. The medical implant system ofclaim 25, wherein the head includes a loop extending laterally from the ring.

28. The medical implant system ofclaim 23, wherein at least one of the head and the base is asymmetrical relative to the longitudinal axis of the stem.

29. The medical implant system ofclaim 19, wherein the head includes a laterally-extending loop.

30. The medical implant system ofclaim 19, wherein the base has a first edge having a first curvature and a second edge having a second, flatter curvature.

31. The medical implant system ofclaim 29, wherein the head has a loop extending laterally in a direction opposite to the second edge of the base.

32. The medical implant system ofclaim 19, wherein the body cavity is a stomach and the opening is in stomach tissue and wherein the system further includes a tool proportioned for transoral insertion into the body cavity and for extension through the opening in the stomach tissue, the tool engageable with the head to deform the head into the second position, the opening of the implant slidable over the tool through an oral cavity into position within the stomach.

33. The medical implant system ofclaim 32, wherein the head includes a loop and wherein the tool is engageable with the loop.

34. The medical implant system ofclaim 33, wherein the tool includes a jaw having an open position and a closed position.

35. The medical implant system ofclaim 32, wherein:

the system includes a plurality of the anchors;

the implant includes a plurality of openings; and

the system includes a plurality of tools each transorally insertable into the stomach and extendable through separate openings formed in stomach tissue, each tool engageable with the head of a corresponding one of the anchors to deform the head into the second position, the opening of the implant slidable over the plurality of tools into engagement with the anchors.

36. The medical implant system ofclaim 32, wherein the system is further for forming the opening in the stomach tissue, and wherein the system further includes a plication tool and a tissue cutting element, wherein the anchor is positionable within an opening formed by the tissue cutting element in a plication formed by the plication tool.

37. The medical implant system ofclaim 36, wherein the tissue cutting element is on the plication tool.

38. The medical implant system ofclaim 37, wherein the plication tool includes a plurality of staples advanceable through tissue for forming a plication.

39. The medical implant system ofclaim 19, wherein the implant comprises a wall bounding an interior, and wherein the opening is formed in the wall.

40. The medical implant system ofclaim 39, wherein the implant is a flow-restrictive implant proportioned for implantation within a stomach having the tissue opening formed in tissue of the stomach.

41. The medical implant system ofclaim 35, further including:

an implant pusher having at least one engaging pin on a distal portion of the implant pusher, the implant pusher proportioned for transoral advancement into the stomach with the implant coupled to the engaging pin.

42. The medical implant system ofclaim 32, further including instructions for use instructing the user to implant the anchor and implant according to the following steps:

coupling the anchor to the tool;

transorally advancing the tool into the stomach;

advancing a second tool into the stomach and passing the second tool through the tissue opening;

after passing the second tool through the opening, engaging the anchor using the second tool;

withdrawing the second tool from the opening to draw the head through the opening;

releasing the anchor from the first tool; and

passing the implant over the second tool and over the head.

43. A restrictive stomach implant, comprising:

a wall including a plurality of anchor points and compliant sections between the anchor points.

44. The restrictive stomach implant ofclaim 43, wherein the compliant sections include at least one fold positioned between each pair of anchor points.

45. The restrictive stomach implant ofclaim 43, wherein the wall is formed of first regions of a first material and second regions of a second material, the first regions more compliant than the second regions.

46. The restrictive implant ofclaim 45, wherein the wall is formed of the first material, and wherein the second regions include sections of the second material positioned on the first material.

47. The restrictive implant ofclaim 46, wherein the sections of second material include longitudinal ribs.

48. The restrictive implant ofclaim 45, wherein the wall includes a distal orifice, and wherein the sections of second material include a ring of second material encircling the distal orifice.

49. The restrictive implant ofclaim 43, wherein the wall defines a sleeve having a proximal edge, the proximal edge including proximally extending peaks.

50. The restrictive implant ofclaim 49, wherein the peaks define chutes for directing ingested food material from a proximal portion of the implant towards a distal portion of the implant.

51. The restrictive implant ofclaim 43, wherein the wall includes a distal orifice defined by an edge, wherein the edge includes a plurality of folds.

52. The restrictive implant ofclaim 43, wherein the anchor points comprise a plurality of anchor openings formed in the wall.

53. The restrictive implant ofclaim 52, wherein each of the anchor openings includes a circumferential reinforcement.

54. A medical implant system for use in a patient comprising:

an anchor configured to be coupled to tissue within a body cavity;

a first tool having a proximal portion, a distal portion, and a shaft between the proximal and distal portions, the distal portion including a coupling element operable to couple the first tool to the anchor, the first tool proportioned such that when the coupling element is coupled to the anchor within the body cavity, the proximal portion of the first tool extends out of the patient; and

an implant having an opening proportioned to slide over the shaft and distal end of the first tool and into engagement with the anchor.

55. The medical implant system according toclaim 54 wherein the opening and the first tool are proportioned to allow the opening to slide over a proximal tip of the first tool.

56. The medical implant system according toclaim 55, wherein the proximal tip is tapered in a proximal direction.

57. The medical implant system according toclaim 54, further including a second tool having a distal end with a coupling element adapted to be detachably coupled to the implant, the implant opening slidable over the shaft of the first tool when the implant is coupled to the coupling element of the second tool, the second tool proportioned such that a proximal end of the second tool remains outside the patient during advancement of the implant over the distal end of the first tool and into engagement with the anchor within the body cavity.

58. The medical implant system according toclaim 57, wherein the coupling element of the second tool includes at least one longitudinally-extending pin extendable through a portion of the implant.

59. The medical implant system according toclaim 58, wherein the pin includes a free distal end, and wherein the coupling element further includes a distal containment element positioned such that relative movement of the free distal end of the pin and the distal containment element towards one another to a first position prevents detachment of the implant from the pin, and such that relative movement of the free distal end of the pin away from one another to a second position exposes the pin to allow detachment of the implant from the pin.

60. The medical implant system according toclaim 59, wherein the coupling element of the second tool includes a plurality of longitudinally-extendable pins extendable through the implant, and wherein in the second position the distal containment element is positioned to detachment of the implant from the plurality of pins.

61. The medical implant system according toclaim 60, wherein the implant includes a base, a wall coupled to the base and surrounding an interior, a first opening in the base, and a plurality of second openings surrounding the exit port, and wherein the plurality of pins are positionable within the plurality of second openings, with a shaft of the second tool extending through the exit port.

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