WO2005037152A1 - Devices and methods for retaining a gastro-esophageal implant - Google Patents

Devices and methods for retaining a gastro-esophageal implant Download PDF

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Publication number
WO2005037152A1
WO2005037152A1 PCT/US2004/033007 US2004033007W WO2005037152A1 WO 2005037152 A1 WO2005037152 A1 WO 2005037152A1 US 2004033007 W US2004033007 W US 2004033007W WO 2005037152 A1 WO2005037152 A1 WO 2005037152A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
stomach
implant
medical implant
pocket
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/033007
Other languages
English (en)
French (fr)
Inventor
Richard S. Stack
Dan Balbierz
John Lunsford
Kevin Van Bladel
William S. Eubanks, Jr.
William L. Athas
Richard A. Glenn
Richard Kouri
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synecor LLC
Original Assignee
Synecor LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to JP2006534310A priority Critical patent/JP5252806B2/ja
Priority to ES04794380T priority patent/ES2377934T3/es
Priority to EP04794380A priority patent/EP1680054B1/en
Priority to US10/575,222 priority patent/US8784500B2/en
Priority to AT04794380T priority patent/ATE534354T1/de
Application filed by Synecor LLC filed Critical Synecor LLC
Publication of WO2005037152A1 publication Critical patent/WO2005037152A1/en
Anticipated expiration legal-status Critical
Priority to US11/439,461 priority patent/US8206456B2/en
Priority to US13/492,732 priority patent/US9445791B2/en
Priority to US14/278,230 priority patent/US9248038B2/en
Priority to US15/234,515 priority patent/US10285836B2/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A61F5/0079—Pyloric or esophageal obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0083—Reducing the size of the stomach, e.g. gastroplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0419—H-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0454—Means for attaching and blocking the suture in the suture anchor the anchor being crimped or clamped on the suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/301—Surgical pincettes, i.e. surgical tweezers without pivotal connections with three legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306—Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs

Definitions

  • 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.
  • Fig. IB illustrates the tissue layers forming the stomach wall. The outermost layer is the serosal layer or "serosa" S and the innermost layer, lining the stomach interior, is the mucosal layer or "mucosa" MUC.
  • FIG. 1 A is a schematic illustration of a human stomach and a portion of the small intestine.
  • Fig. IB is a cross-sectional perspective view of a portion of a stomach wall, illustrating the layers of tissue forming the wall.
  • Fig. 2A is a perspective view of a restrictive device of a type that may be used to promote weight loss.
  • Fig. 2B is a cross-sectional elevation view of an esophagus and proximal stomach, showing the restrictive device of Fig. 2A implanted in the gastro-esophageal junction region.
  • Fig. 3 is a perspective view illustrating a restrictive device retained by tissue structures in the proximal portion of a human stomach.
  • Figs. 4 A and 4B are perspective views of alternate embodiments of restrictive implant utilizing a ring as a restrictive element.
  • Fig. 4C is a perspective view illustrating an alternate embodiment of a restrictive implant utilizing a notched disk as a restrictive element. The implant is shown positioned at the gastro-esophageal junction region.
  • Fig.4D is a cross-sectional front view showing the implant positioned within the gastro-esophageal junction region.
  • Fig. 4E is a perspective view similar to Fig. 3 showing an inflatable restrictive implant retained within the gastro-esophageal junction region. Also shown are an inflation tube and an endoscope.
  • Fig. 4F is similar to Fig. 4E but shows the implant following inflation, with the inflation tube still attached to the restrictive implant.
  • FIG. 10A is a cross-sectional perspective view of a portion of stomach wall, showing yet another type of plication that may be used.
  • Fig. 10B is a cross-sectional top view of a stomach, similar to Fig. 6D, showing three such plications in the wall of a stomach.
  • Figs. 11A through 1 ID are a sequence of cross-sectional perspective views of a portion of stomach wall, showing yet another plication method for forming tissue pockets.
  • Figs. 12A through G are a sequence of cross-sectional perspective views of a proximal portion of a stomach, illustrating another method for forming plications to create tissue pockets.
  • Fig. 33 A is a perspective view of an example of an alternative restrictive device, in which the restrictive device takes the form of a rigid ring.
  • Fig. 33B is a perspective view of another example of an alternative restrictive device, which has a tapered geometry.
  • Fig. 33C is a perspective view of still another example of an alternative restrictive device, which has a bellows configuration.
  • Fig. 33D is a perspective view of another example of an alternative restrictive device, which includes a collection of separate segments that collectively form a restriction in the stomach.
  • Fig. 34A is a side elevation view of a stomach which has been re-shaped to include a tunnel.
  • Fig. 34B is a cross-section view of the stomach showing a restrictive device anchored in the tunnel.
  • FIG. 43A illustrates a laparoscopic approach to the stomach exterior using a cutting and stapling instrument
  • Fig.43C illustrates the cut and attachment lines formed using the laparoscopic instrument
  • Fig 43D is a cross-section taken along the plane designated 43D-43D in Fig. 43C
  • Fig. 43E illustrates the step of drawing regions of serosal tissue into contact at the stomach exterior
  • Figs. 43F through 43H are cross- section views similar to Fig. 43D illustrating methods for securing the drawn regions of serosal tissue.
  • Fig. 431 is similar to Fig. 43F and further illustrates optional off-setting and attachment of the cut tissue edges.
  • Fig. 44A through 44C are yet another alternate method for forming tissue pockets within a stomach, in which: Fig. 44A illustrates formation of cuts through the stomach wall; Fig. 44A illustrates weaving of portions of the implant through the cuts; and Fig. 44 illustrates the drawing together and attachment of serosal tissue regions on the stomach exterior.
  • restrictive device 2 of Fig. 2A This application also describes alternative embodiments to the restrictive device 2 of Fig. 2A.
  • the terms "restrictive devices”, “satiation devices,” “obstructive devices” or “satiation pouches” will be used to mean devices or pouches intended to induce weight loss in one or more of a variety of ways. These include, but are not limited to, slowing the rate at which food passes from the esophagus into the stomach, physically restricting the amount of food that can be consumed, and/or imparting pressure against portions of the body (e.g.
  • Figs. 3 - 24 illustrate implants and implantation techniques which minimize or largely avoid connecting the implant and body tissue using connectors (i.e. sutures, staples, clips etc.) that both penetrate the surface of the body tissue and physically connect to the implant.
  • a portion of the implant is captured by a tissue structure formed within the body by re-shaping body tissue.
  • tissue structures may be strictures created in the stomach to retain the device, or they may be pockets, tunnels, ledges or other barriers against implant migration formed by attaching regions of tissue and or creating plications in the stomach tissue.
  • the tissue structures may be formed using endoscopic procedures passed through the esophagus into the stomach, and/or using laparoscopic or surgical procedures.
  • Fig. 3 shows a restrictive implant 10 being retained by plications 12 formed in stomach tissue.
  • the plications may be formed by grasping sections of tissue and suturing the tissue together to form pocket-like tissue structures 14.
  • Such structures are pocketlike in the sense that they have an interior space bounded by tissue, and at least one opening extending into the interior space.
  • the interior walls of the pocket may lie in contact with one another, collapsing the interior space in the same way the space within a shirt pocket is collapsed.
  • the pockets may also be tunnel-like in the sense that there may be openings on opposite sides of the interior space so that an instrument or portion of a medical device may be passed through the pocket. If necessary, more than two such openings may be provided in the pocket. In other embodiments, the pockets may be more tubular or tunnel-like.
  • the implant 10 includes leg members 16 that are retained within the pockets 14 of the plications 12. During implantation, the leg members may be inserted into the pockets 14, or the implant may be positioned before the plications are formed, in which case the placations 12 may be formed around the leg members 16.
  • buttressing material such as bovine pericardium strips, Teflon strips or polycarbonate strips so as to facilitate retention of the staples/suture within the body tissue until such time as the contacting tissue layers adhere together.
  • pledgets, t-bars, etc. of the type described in connection with Figs. 26 A - 30B may be used to buttress the sutures/staples until such time as tissue adhesion occurs. Over time, adhesions form between the tissue surfaces held in contact by the sutures, thereby creating a much stronger bond between the tissue surfaces than would be achieved using sutures alone.
  • dissolvable or bioabsorbable sutures may be used to create the plications. The procedure illustrated in Figs.
  • Fig. 9B illustrates another configuration of tissue pocket 14c in which the contact lines forming plications 12c are oriented in shear. This configuration utilizes three plication folds and forms a very long region of serosal contact 220.
  • Figs. 10A, 1 ID, and 36A illustrate alternative forms of tissue structures that may be formed, in which the serosal contact lines form an adhesion that is in peel, but that differ from the Fig.
  • tissue pocket 244 is formed of serosal tissue, it may be desirable to line the pocket 244 with a stent-like device 246 or another liner to both reinforce the pocket and protect the serosal surface from the acidic stomach environment.
  • the procedure continues with formation of as many pockets as are needed to retain the desired implant in the stomach.
  • implants or portions of implants are fed into the pockets for retention within the stomach.
  • legs 16 of a device such as device 10 (Fig. 3) may be extended through the pockets.
  • other forms of implants e.g. capsules containing diagnostic or therapeutic agents or devices, c-bars 248 of Fig. 12G to which implants or space occupying devices may be attached
  • implants e.g. capsules containing diagnostic or therapeutic agents or devices, c-bars 248 of Fig. 12G to which implants or space occupying devices may be attached
  • the device may optionally be provided with a vacuum source (not shown) that allows a vacuum to be applied to draw tissue into the recess 54.
  • a fourth lumen having a plurality of inlets exposed to the interior of the recess may be provided and be connectable to a vacuum source.
  • a suture 62 is disposed within the suture lumen 56.
  • the suture 62 has a suture catch 64 on its distal end, positioned adjacent to the opening of the lumen 56 into the recess 54.
  • a suture needle 66 is slidable within the needle lumen 58.
  • the device 48 is introduced into the stomach under endoscopic visualization.
  • the device 48 is placed into contact with the target stomach tissue, and tissue is drawn into the recess 54. This may be accomplished by pressing the recess 54 against the tissue surface, or by activating a vacuum source configured to draw tissue into the recess 54.
  • the tissue is comprised of several tissue layers: the mucosa MUC which lines the stomach interior, the submucosa SM beneath the mucosa MUC, the muscularis M, and the serosa S which lines the stomach exterior.
  • the dimensions of the recess 54 and the position of the blade 68 are chosen such that tissue will be drawn into recess 54 by an amount that will appropriately align the tissue layer(s) to be removed with the blade 68.
  • the mucosa MUC will be removed to expose the submucosa SM or both the mucosa and submucosa SM will be removed to expose the muscularis M.
  • removal of the mucosa MUC will be described in connection with Figs. 13C through 13F.
  • the cutting blade 68 of the Fig. 13B embodiment may be replaced with an RF loop snare 74.
  • the loop snare 74 is oriented such that tissue passes into the loop when tissue is drawn into the recess 54. Once tissue is within the recess, the snare (which is energized with RF energy) in retracted in a proximal direction to shave off the target tissue layer.
  • the cutting blade is replaced by an RF electrode plate 76 disposed within the recess. Tissue drawn into the recess 54 is thus drawn into contact with the plate 76 and is ablated.
  • the contour of the liner 90 silhouettes that of the proximal portion of the pouch 2 as shown.
  • the liner 90 is sufficiently rigid to restrict movement of the pouch 2 up or down within the stomach.
  • a ring 94 is positioned on the exterior surface of the body wall surrounding the waist portion 92 of the hourglass liner 90, such that it causes the body wall tissue to conform to the hourglass shape of the liner 90, altering the shape of the stomach by creating a stricture as shown. If necessary, the ring 94 may be secured in place using partial or full thickness sutures, barbs, clips etc.
  • the ring 94 may have features similar to the collar 56 described in connection with Fig. 31G below.
  • the relative positions of the ring 94, liner 90 and pouch 2 are such that the ring holds the liner 90 in position, and the liner in turn holds pouch 2 in position.
  • Optional mounting studs 96 may be connected to the pouch 2 and sutured through the liner 90 to the body wall using partial or full thickness sutures. Further details of studs of this type are described in connection with Figs. 29A-29F.
  • the liner 90 protects the mucosal lining of the stomach against erosion, and both the liner 90 and the ring 94 are themselves sufficiently flexible to prevent minimize tissue erosion caused by their own surfaces.
  • An optional feature in the Fig. 17 configuration includes a fundal component 98 extending in a distal direction from the liner 90.
  • the ring 94a may be more disk-like and include windows 110 for receiving the plication tissue as well as an integral or detachable restrictive orifice 114.
  • the exterior perimeter of the ring seals against the surrounding tissue sufficiently to prevent passage of large amounts of food between the perimeter and adjacent tissue.
  • the ring 94 may also function as an anchor to which the implant may be attached using sutures, clips etc.
  • pledgets 130b may be formed of mesh or other material known to promote cell ingrowth, such that over time the stomach wall tissue will grow into the pledget to enhance anchoring.
  • a pledget may be formed in situ by injecting a drop of gel onto the exterior surface of the stomach, where the gel is a type that will solidify on the tissue surface.
  • the gel may be delivered laparoscopically by approaching the stomach wall from outside the stomach, or it may be delivered endoscopically by injecting the gel using a needle passed through the wall of stomach from the stomach interior. Once the gel hardens into a pledget, the implant may be anchored to the hardened gel pledget using sutures, clips, etc. passed through the stomach wall.
  • Figs. 29B through 3 IF various devices may be used to connect the fastener 96 to the pledget 130. It should be noted that although the implant is only shown in Fig. 29B, it should be assumed that in Figs. 29C through 29F implant is attached to the fastener such as in the manner shown in Fig. 29B. Referring to Fig.
  • Collars Another form of external reinforcement device is an external collar encircling the exterior of the stomach.
  • Figs. 31A through 311 show a variety of collar configurations. Some of these configurations are intended to be physically connected to the implant using sutures or other connection methods, including those shown in Figs. 29B - 29F for connecting the implant to the pledget-type devices. These connections may be made with or without the stud fasteners of Fig. 29A.
  • the collars When connected to the implant, the collars may function like the pledgets 130 to facilitate even distribution of forces around the implant.
  • the collars and pledgets may also be combined such that a collar encircles the exterior stomach wall and pledgets on the exterior surface of the collar are connected to the device using sutures passed through the collar and the stomach wall.
  • collar 178 may include a sleeve 192 that is slidable over the collar as indicated by arrows to retain the ends of the collar 178 together once the collar has been positioned around the stomach.
  • Figs. 20C, 22A, 22B, 23 and 24 Other restrictive devices and methods of retaining them are shown in Figs. 20C, 22A, 22B, 23 and 24.
  • Figs. 33A through 33D show restrictive devices having alternative features which may likewise minimize risk for detachment. These devices may be used with or without the various attachment devices described in this application.
  • Fig. 33 A shows a rigid ring 194 positionable in the gastro-esophageal junction region and attached using sutures or other means similar to those described for pouch 2.
  • FIG. 33B shows an alternative restrictive device 198 which has a tapered configuration, such that forces imparted against the device by the stomach (as indicated by arrows) as well as forces imparted by food passing through the tapered passageway 200 in the device 198 will cause the device to seat more tightly within the gastro- esophageal junction region.
  • sutures, anchors, clips, adhesives etc. may be used to attach the device 198 to the stomach walls.
  • Fig. 33C shows a restrictive device 202 that is pleated between anchor points 204.
  • a reinforcing patch 300 may be positioned between the tissue layers (e.g. serosal layers as shown, or alternatively mucosal layers).
  • the patch may function as a scaffolding that promotes tissue ingrowth and/or function to reinforce the adhesions that form.
  • the patch may be a synthetic or non-synthetic mesh, porous material, slotted material, or any other material through which adhesions will form or onto which tissue will grow.
  • Figs. 39A through 42B illustrate an embodiment similar to the Fig. 36F embodiment in which serosal plications 242 are formed to create a circumferential ridge 244 and in which a restrictive implant 246 is attached to the ridge 244 or seats against the ridge without a physical connection.
  • the Fig. 39A/B embodiment differs, however, in that patch 300 is positioned between the serosal layers. Anchoring studs or pledgets 250 may be passed through the serosal tissue layers and the patch 300 as shown to secure the plication and (if desired) to serve as an attachment point for an implant such as a restrictive device.
  • Fig. 40 illustrates an embodiment similar to Fig.
  • a pair of serosal plications are formed, each with a patch 300 between the serosal layers.
  • the folds 20 of the two plications are connected to one another as shown in Fig. 42B to form a pocket 304 between the plications.
  • the ends of the folds 20 may be cut prior to attachment as described with respect to Figs. 8C and 8D, or they may be left uncut. Additionally, another patch may be positioned between the folds to reinforce the adhesions that will ultimately grow between them.

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Priority Applications (9)

Application Number Priority Date Filing Date Title
JP2006534310A JP5252806B2 (ja) 2003-10-10 2004-10-08 胃食道インプラントを保持するデバイス及び方法
ES04794380T ES2377934T3 (es) 2003-10-10 2004-10-08 Implante gastroesofágico
EP04794380A EP1680054B1 (en) 2003-10-10 2004-10-08 Gastro-esophageal implant
US10/575,222 US8784500B2 (en) 2003-10-10 2004-10-08 Devices and methods for retaining a gastro-esophageal implant
AT04794380T ATE534354T1 (de) 2003-10-10 2004-10-08 Gastroösophageales implantat
US11/439,461 US8206456B2 (en) 2003-10-10 2006-05-23 Restrictive and/or obstructive implant system for inducing weight loss
US13/492,732 US9445791B2 (en) 2003-10-10 2012-06-08 Systems and methods related to gastro-esophageal implants
US14/278,230 US9248038B2 (en) 2003-10-10 2014-05-15 Methods for retaining a gastro-esophageal implant
US15/234,515 US10285836B2 (en) 2003-10-10 2016-08-11 Systems and methods related to gastro-esophageal implants

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US51026803P 2003-10-10 2003-10-10
US60/510,268 2003-10-10
US10/843,702 2004-05-11
US10/843,702 US20050247320A1 (en) 2003-10-10 2004-05-11 Devices and methods for retaining a gastro-esophageal implant
US10/898,036 2004-07-23
US10/898,036 US7431725B2 (en) 2003-10-10 2004-07-23 Devices and methods for retaining a gastro-esophageal implant

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US10/898,036 Continuation US7431725B2 (en) 2003-10-10 2004-07-23 Devices and methods for retaining a gastro-esophageal implant
US10/898,036 Continuation-In-Part US7431725B2 (en) 2003-10-10 2004-07-23 Devices and methods for retaining a gastro-esophageal implant
US11/439,461 Continuation-In-Part US8206456B2 (en) 2003-10-10 2006-05-23 Restrictive and/or obstructive implant system for inducing weight loss

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US11/439,461 Continuation-In-Part US8206456B2 (en) 2003-10-10 2006-05-23 Restrictive and/or obstructive implant system for inducing weight loss
US57522207A Continuation 2003-10-10 2007-07-30
US14/278,230 Continuation US9248038B2 (en) 2003-10-10 2014-05-15 Methods for retaining a gastro-esophageal implant

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US20050247320A1 (en) 2005-11-10
JP5252806B2 (ja) 2013-07-31
US20070276432A1 (en) 2007-11-29
US20070060932A1 (en) 2007-03-15
US9248038B2 (en) 2016-02-02
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EP3141192A1 (en) 2017-03-15
US20100241146A1 (en) 2010-09-23
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US20140249465A1 (en) 2014-09-04
US9180035B2 (en) 2015-11-10
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EP1680054A1 (en) 2006-07-19
US20050096673A1 (en) 2005-05-05
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ATE534354T1 (de) 2011-12-15
US8784500B2 (en) 2014-07-22
US7431725B2 (en) 2008-10-07

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