Patent Abstract:
The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.

Full Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract. 
       BACKGROUND OF THE INVENTION 
       [0002]    In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach&#39;s volume and subsequent bypass of the intestine. 
         [0003]    Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to severely obese patients (morbid obesity, Body Mass Index &gt;=40) due to their complications, including the risk of death, leaving patients who are considered obese or moderately obese with few, if any, interventional options. 
         [0004]    In addition to the above described gastrointestinal reduction surgery, endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine. 
         [0005]    A known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position. To improve anchoring and stability of the sleeve, it is further known to provide the stent with barbs which penetrate the surrounding tissue. 
         [0006]    This notwithstanding, it has been observed that the endoscopic sleeves tend to move inside the GI tract and migrate away from their initially planned position. 
         [0007]    U.S. Pat. No. 7,220,237 B2, Method and device for use in endoscopic organ procedures, to Gannoe et al. describes procedures for internally lining portions of the gastrointestinal tract, using tubular endoluminal sleeves and stapling devices for circumferentially acquiring tissue of the gastric wall and fixating a circular section of the acquired tissue to which an endoluminal sleeve is secured by shape interference. 
         [0008]    However, the known methods and devices for placing and securing endoluminal linings within hollow organs, particularly within the gastrointestinal tract, are not yet satisfactory with regard to a reliable anchoring and conservation of the planned position of the endoluminal sleeve. 
         [0009]    Moreover, the known devices and methods do not sufficiently address the need of creating sealed or leak tight connection regions between the endoluminal sleeve and the hollow organ in order to obtain a desired flow scheme of the food flow and the flow of bodily fluids, such as gastric juices, bile and pancreatic fluid. 
         [0010]    Accordingly, there is a need for improved devices and procedures for positioning and anchoring an endoluminal sleeve in the GI tract. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention provides for an improved apparatus and method for the transoral, or endoscopic, positioning and anchoring of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, portions of or the entire length of the intestinal tract, etc., unless specified otherwise. In the case of the present invention, the surgeon or endoscopist may insert devices as described below through the patient&#39;s mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient&#39;s stomach or other intestinal tract, and does not necessarily require any external incision. 
         [0012]    At least part of the above identified needs are met by an endoluminal applier for anchoring a tubular lining to a hollow organ, the applier comprising a fastening assembly having:
   a fastening cavity adapted to receive a tissue portion of said hollow organ together with a portion of said lining,   a suction device with one or more suction apertures opening into the fastening cavity and adapted to acquire the tissue portion and lining into the fastening cavity,   a stitching mechanism adapted to stitch into said fastening cavity and to apply a running suture to the acquired tissue portion and lining.   
 
         [0016]    This provides an instrumentation which may be used similarly to known circular staplers, but obviates the use of rigid staples and reduces the stiffness of the sutured seam with respect to fastening procedures with staplers. Moreover, the stitching force necessary to pierce a single perforating needle through the acquired tissue and lining is significantly lower than the forces normally required for stapling. 
         [0017]    In accordance with an aspect of the invention, the fastening cavity has a first sewing surface defining a first slot extending along a stitching path and an opposite second sewing surface facing the first sewing surface and defining a second slot extending along the stitching path, and the stitching mechanism comprises a perforating needle arranged in the first slot, a thread catch arranged in the second slot, and a needle driving assembly adapted to:
   repeatedly moving the perforating needle and the thread catch with respect to each other to create a running suture through said fastening cavity, and   moving the perforating needle and the thread catch along the first and second slots to extend the running suture along the stitching path.   
 
         [0020]    In accordance with a further aspect of the invention, the stitching mechanism comprises:
   a continuous annular needle path, said needle path crossing the fastening cavity and being formed inside an unobstructed disentangling space;   a needle and needle drive assembly arranged for movement of the needle along the needle path;   a suture secured to the needle and extending from the needle through the disentangling space and through the fastening cavity outside the fastening assembly, so that the needle can repeatedly move along the entire needle path without winding the suture around any part of the fastening assembly.   
 
         [0024]    This allows to position the applier with the fastening cavity over a portion of tissue and lining, acquire the tissue portion and lining in the fastening cavity, sending the needle with the suture through the acquired tissue portion and lining, releasing the tissue portion and lining from the fastening cavity, rotating or moving the fastening cavity to the next portion of tissue and lining and moving the needle along the annular needle path to an initial needle position (without tangling the suture), and repeating the sequence until a complete running suture, e.g. a circumferential purse string suture, is created. 
         [0025]    In accordance with a yet further aspect of the invention, the fastening assembly forms a plurality of fastening cavities arranged along a circumference of the fastening assembly, as well as a continuous annular needle path which crosses all fastening cavities and which extends inside a continuously radially externally open annular sewing groove formed along the circumference of the fastening assembly. The stitching mechanism comprises a needle and needle drive assembly arranged for movement of the needle along the needle path, as well as a suture secured to the needle and extending from the needle inside the annular sewing groove, so that the needle can repeatedly move along the entire needle path and the thus obtained suture loop can be moved radially out of the sewing groove. 
         [0026]    This embodiment allows to contemporaneously acquire a plurality of tissue portions and lining portions along a circumference around the fastening assembly, then sending the needle successively through all acquired tissue and lining portions, thereby obtaining a (possibly closed loop) running purse string suture between the lining and the tissue of the hollow organ, and eventually releasing the purse string sutured tissue and lining from the applier. 
         [0027]    These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0028]      FIG. 1  illustrates an endoluminal applier for anchoring a tubular lining to a hollow organ, the applier being in a closed configuration; 
           [0029]      FIG. 2  illustrates the applier of  FIG. 1  in an open configuration; 
           [0030]      FIG. 3  illustrates a transoral introduction of the applier of  FIG. 1  to the duodenum; 
           [0031]      FIG. 4  illustrates a method step in which the applier is opened after positioning in the target location in the GI tract; 
           [0032]      FIG. 5  illustrates the applier and a method for acquiring tissue of the hollow organ to which the tubular lining is intended to be secured in accordance with an embodiment; 
           [0033]      FIG. 6  illustrates the applier in a closed configuration in which the acquired tissue and an anchoring portion of the lining is clamped between opposite sewing surfaces of a fastening cavity of the applier and ready for the application of a running suture; 
           [0034]      FIG. 7  is a schematic cross-sectional view of a tubular lining sutured to a target location of the hollow organ, but still in a collapsed or packed shape; 
           [0035]      FIG. 8  illustrates the tubular lining after anchoring and full extension within a section of the GI tract; 
           [0036]      FIG. 9  is a partially sectioned side view of the applier in accordance with a further embodiment; 
           [0037]      FIG. 10  is sectional view in plane X-X in  FIG. 9 ; 
           [0038]      FIGS. 11A through 11E  illustrate a sequence of movements accomplished by a stitching mechanism of the applier in accordance with an embodiment; 
           [0039]      FIG. 12  illustrates an endoluminal applier for securing a tubular lining to a hollow organ in accordance with a further embodiment; 
           [0040]      FIG. 13  is a sectional view in plane XIII-XIII in  FIG. 12 ; 
           [0041]      FIG. 13A  illustrates a sequence of an open loop suture disentangling implemented by the applier of  FIG. 12 ; 
           [0042]      FIG. 14  is sectional view in plane XIV-XIV in  FIG. 12 ; 
           [0043]      FIG. 15  is a sectional view of a purse string suture through an endoluminal lining and an intestinal wall created by means of the applier in  FIG. 12 ; 
           [0044]      FIG. 16  illustrates an endoluminal applier for securing a tubular lining to a hollow organ in accordance with a further embodiment; 
           [0045]      FIG. 17  is sectional view in plane XVII-XVII in  FIG. 16  during a suturing step; 
           [0046]      FIG. 18  is sectional view in plane XVII-XVII in  FIG. 16  during a tissue releasing step; 
           [0047]      FIGS. 19 and 20  illustrate further devices and methods for endoluminally securing a lining inside a GI tract. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0048]    Referring to the drawings where like numerals denote like anatomical structures and components throughout the several views,  FIG. 1  depicts an endoluminal applier  1  for anchoring a tubular lining  2  to a hollow organ  3 , particularly to a section of the GI tract of a patient. 
         [0049]    The applier  1  comprises a fastening assembly  4  which has a fastening cavity  5  adapted to receive a tissue portion  6  of the hollow organ  3  together with a portion of the lining  2 , a suction device  7  with one or more suction apertures  8  opening into the fastening cavity  5  and adapted to acquire the tissue portion  6  and lining  3  into the fastening cavity  5 . The fastening assembly  4  further comprises a stitching mechanism  9  adapted to stitch into the fastening cavity  5  and to apply a running suture to the acquired tissue portion  6  and lining  2 . 
         [0050]    In accordance with an embodiment, the fastening cavity  5  has a first sewing surface  10  defining a first sewing slot  11  extending along a stitching path and an opposite second sewing surface  12  facing the first sewing surface  10  and defining a second sewing slot  13  extending along the stitching path. The stitching mechanism  9  comprises a perforating needle  14  arranged in the first sewing slot  11 , a thread catch  15  arranged in the second sewing slot  13 , and a needle driving assembly  16 . The needle driving assembly  16  is adapted to repeatedly moving the perforating needle  14  and the thread catch  15  with respect to each other to create a running suture through the fastening cavity  5 , and to moving the perforating needle  14  and the thread catch  15  along the first and second sewing slots  11 ,  13  in a manner to extend the running suture along the stitching path. 
         [0051]    More specifically, the needle driving assembly  16  can be adapted to repeatedly moving the perforating needle  14  with a suture loop forward through the fastening cavity  5  into the second sewing slot  13  and then backward in the first sewing slot  11 , and repeatedly moving the thread catch  15  in engagement with the suture loop  17  to hold the suture loop in the second sewing slot  13  during the backward movement of the perforating needle  14 , and moving the perforating needle  14  and the thread catch  15  along the stitching path with respect to the first and second sewing surfaces  10 ,  12  while the suction device  7  or clamping means which will be described further below constrain the tissue portion  6  and the lining  2  stationarily within the fastening cavity  5 . 
         [0052]      FIGS. 11A to 11E  illustrate an exemplary embodiment of a movement sequence of the stitching mechanism  9 , in which a basic chain stitch is created through the lining  2  and tissue portion  6  by first sending the perforating needle  14  forward through the tissue portion and lining held between the first and second sewing surfaces  10 ,  12 . Then, as the perforating needle  14  is moved backward, the friction of the suture  17  against the tissue  6  and lining  2  is sufficient to form a small loop on their side facing the second sewing slot  13 . That loop is caught by the hook shaped thread catch  15  housed within the second sewing slot  13 . The needle driving assembly  16  then moves both the perforating needle  14  and the thread catch  15  forward along the stitching path, thereby projecting the previously caught loop of suture in the position of the subsequent stitch. In this manner, the next forward movement of the perforating needle  14  goes through the previously caught loop of suture. The thread catch  15  then releases the previously caught loop of suture and picks up the new loop and the process repeats. 
         [0053]    In accordance with an embodiment ( FIGS. 1 through 10 ), the fastening assembly  4  comprises a proximal portion  18  having an annular distal clamping surface which forms the first sewing surface  10 , and a distal anvil  19  having an annular proximal clamping surface which faces the distal clamping surface and forms the second sewing surface  12 . The anvil  19  is movable relative to the proximal portion  18  for clamping a ring shaped tissue portion  6  between the first and second sewing surfaces  10 ,  12 . In this embodiment, the stitching path and, hence, the sewing slots  11 ,  13  have a closed annular, preferably circular shape. 
         [0054]    The fastening assembly  4  may further comprise a ring shaped lining seat  20  adapted to receive the tubular lining  2  such that an elongate body portion  21  of the lining is held in a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and a ring shaped anchoring portion  22  of the lining  2  is held to overlap one of said first and second sewing surfaces  10 ,  12  and sewing slots  11 ,  12 . 
         [0055]    This assures a correct relative positioning of the lining  2  anchoring portion  22 , the stitching mechanism  9  and the sewing surfaces  10 ,  12 . Moreover, the positioning of the lining  2  on the lining seat  20  may take place extracorporeally and does not change during the endoluminal insertion of the applier  1  and during applying the running suture. 
         [0056]    In accordance with an embodiment, the lining seat  8  is formed in the anvil  19  and comprises a distal containment wall  23  ( FIG. 9 ) against which the collapsed and “packed” tubular lining  2 , e.g. an endoluminal sleeve, rests so that it keeps its collapsed and “packed” shape until the lining  2  is pulled or pushed distally over the containment wall  23  during withdrawal of the applier  1  from the sutured sleeve  2 . 
         [0057]    The anvil  19  may be translatably connected to the proximal portion  18  by at least one, preferably two diametrically opposite anvil shafts  24  slidably received in one or more guide holes  25  of the proximal portion  18  and connected with an anvil moving mechanism adapted to move the anvil  19  relative to the proximal portion  18 . 
         [0058]    The suction apertures  8  of the suction device  7  are connectable to an extracorporeal suction pump and may be arranged in the fastening cavity  5  radially internal of the sewing slots  11 ,  13  in a manner to assure an acquisition and positioning of the tissue and lining over the sewing slots. 
         [0059]    The suction apertures  8  can be formed in the first sewing surface  10  and/or in the region of the anvil shaft or shafts  24 . Suction apertures  8  may be also formed in a radially external surface of a ring shaped suction wall  26  provided in the fastening cavity  5  radially inside with respect to the sewing slots  11 ,  13 . 
         [0060]    The anvil moving mechanism is connected through one or more flexible anvil movement transmitters with an extracorporeal anvil movement activation mechanism provided e.g. at a proximal handle portion of the applier  1 . The stitching mechanism  9  can be mechanically activated by flexible rotation transmitters or it can be electrically energized by flexible electric cables. Both 
         [0061]    the anvil movement transmitters and the stitching movement transmitters or electric cables are arranged inside the flexible shaft  27  of the applier  1 . 
         [0062]    In accordance with a further embodiment ( FIGS. 12 through 15 ), the fastening assembly  4  forms a continuous annular needle path  28  which crosses the fastening cavity  5  and which is formed inside an unobstructed disentangling space  29  defined inside the fastening assembly  4 , and the stitching mechanism  9  comprises a needle  30  and needle drive assembly  31  arranged for movement of the needle  30  along the needle path  28 . A suture  17  is secured to the needle  30  and extends from the needle  30  through the disentangling space  29  and through the fastening cavity  5  outside the fastening assembly  4 , so that the needle  30  can repeatedly move along the entire needle path  28  (with the attached suture thread  17  repeatedly forming and disentangling open loops, compare  FIG. 13A , and) without winding the suture  17  around any part of the fastening assembly  4 . 
         [0063]    A thus configured applier allows a sequential acquisition and suturing of a plurality tissue and lining portions along a circumference of the hollow organ by a single continuous suture thread, thereby creating a purse string suture which secures the lining  2  to the wall of the hollow organ, particularly of a section of GI tract. 
         [0064]    Specifically, the applier  1  can be positioned with the fastening cavity  5  over a portion of tissue  6  and lining  2 , acquire the tissue portion  6  and lining  2  in the fastening cavity (by suction), sending the needle  30  with the suture  17  through the acquired tissue portion and lining, then releasing the tissue portion and lining from the fastening cavity  5 , rotating or moving the fastening cavity  5  to the next portion of tissue and lining and moving the needle  30  along the annular needle path  28  to an initial needle position (without entangling the suture  17 , compare  FIG. 13A ), and repeating the same sequence until a complete running suture, e.g. a circumferential purse string suture, is created ( FIG. 15 ). 
         [0065]    In order to facilitate a rotation of the fastening assembly  4  to a subsequent tissue portion and lining region and, at the same time, enable a suture feeding to and through the previously sutured portions of tissue and lining, the fastening assembly  4  may comprise an externally continuously open annular suture feeding channel  32  which extends all around the fastening assembly  4  and which is adapted for feeding the suture  17  from any point along the suture feeding channel  32 . 
         [0066]    For this purpose, a reel  33  of suture  17  may be arranged inside the suture feeding channel  32  and adapted to slide along the suture feeding channel  32 , thereby allowing the suture  17  to be unwound from the reel  33  along any point of a circumference of the fastening assembly  4 . 
         [0067]    In accordance with an embodiment, the fastening assembly  4  comprises a side wall  34  which develops circumferentially about a longitudinal axis X. The fastening cavity  5  is formed in the side wall  34  and has a circumferential extension with respect to the axis X and a longitudinal axial extension parallel to the axis X, wherein the circumferential extension is preferably smaller than the axial extension. The fastening cavity  5  is delimited by a first sewing surface  10  and an opposite second sewing surface  12  which define a needle outlet aperture  35  (in the first sewing surface  10 ) and an opposite needle inlet aperture  36  (in the second sewing surface  12 ). The first and second sewing surfaces  10 ,  12  may be planar and parallel to the longitudinal axis X and may define planes which are radially oriented with respect to the longitudinal axis X. The needle path  28  may be circular and may extend coaxially and perpendicular to the longitudinal axis X of the fastening assembly  4 , whereas the disentangling space  29  may be provided as an internally open disc-shaped empty space which encloses the needle path  28  and which is externally delimited and partially closed by the side wall  34  of the fastening assembly  4 . The disentangling space  29  intersects the first and second sewing surfaces  10 ,  12  and the fastening cavity  5  at the needle outlet aperture  35  and needle inlet aperture  36 . 
         [0068]    The suture feeding channel  32  can be formed in the side wall  34  separate and at a distance from the fastening cavity  5 , thereby preventing the end of the suture which is fed out of the feeding channel  32  to become entangled with the suture end secured to the needle  30 . The suture feeding channel  32  may have a substantially circular shape and extend perpendicular to the longitudinal axis X around a circumference of the side wall  34 . 
         [0069]    In this embodiment, the suction apertures  8  may be formed in the sewing surfaces  10 ,  12  or, alternatively, the suction apertures  8  may open in the disentangling space  29  which is in communication with the fastening cavity  5 . 
         [0070]    Also, the opposing sewing surfaces  10 ,  12  may be movable towards each other by a moving mechanism  37 . In accordance with an embodiment ( FIGS. 12 ,  13 ) the opposing sewing surfaces  10 ,  12  are formed on two jaws  38  which are movable towards each other and away from each other for clamping the acquired tissue portion  6  and lining  2  before passing the needle  30  through them, and for releasing the tissue portion and lining after the passage of the needle  30 . 
         [0071]    In the exemplary embodiment of  FIG. 12 , the jaws  38  are rotatable about an axis parallel to the longitudinal axis X or about the longitudinal axis X in order to improve the compatibility of the jaw movement and the circular needle path  28 . 
         [0072]    For the purpose of releasing the sutured tissue portion  6  and lining  2  from the fastening cavity, a pushing fluid, e.g. air or CO 2  or saline solution may be pumped through (a suction line connected with) the suction apertures  8  into the fastening cavity  5  or through a separate fluid feeding line with apertures opening into the fastening cavity  5 . Also for the purpose of deploying and or unfolding the lining  2 , a pushing fluid, e.g. air or CO 2  or saline solution may be pumped through (a suction line connected with) the suction apertures  8  into the fastening cavity  5  or through a separate fluid feeding line with apertures opening into the fastening cavity  5 . 
         [0073]    The needle drive assembly  31  is adapted to move the needle  30  along the needle path  28 , release the needle  30  after having pushed the needle  30  out of the needle outlet aperture  35  into the fastening cavity  5 , and catch the needle  30  when it enters the needle inlet aperture  36 . For this purpose the needle drive assembly  31  may comprise a plurality of rotatable toothed gear wheels  39  or toothed sliders arranged along the needle path  28 , but outside the disentangling space  29 , and engaging a toothed surface  40  of the needle  30 . The needle  30  itself may have a guide portion  41  which slidingly engages a guide  42  extending along the needle path  28  and adapted to guide and stabilize the needle  30  during its movement along the needle path  28 . 
         [0074]    In accordance with a yet further embodiment ( FIGS. 16 ,  17 ,  18 ), the fastening assembly  4  forms a plurality of fastening cavities  5  arranged along a circumference of the fastening assembly  4  and a continuous annular needle path  28  which crosses all fastening cavities  5  and which extends inside a continuously radially externally open annular sewing groove  43  formed along a circumference of the fastening assembly  4 . The stitching mechanism  9  comprises a needle  30  and a needle drive assembly  31  arranged for movement of the needle  30  along the needle path  28 . A suture  17  is secured to the needle  30  and extends from the needle  30  inside the annular sewing groove  43 , so that the needle  30  can repeatedly move along the entire needle path  28  ( FIG. 17 ) and the resulting loop of suture  17  can be moved radially out of the sewing groove  43  ( FIG. 18 ). 
         [0075]    This embodiment allows to contemporaneously acquire a plurality of tissue portions  6  and lining portions along a circumference around the fastening assembly  4 , then sending the needle  30  successively through all acquired tissue and lining portions, thereby obtaining a running purse string suture between the lining  2  and the tissue of the hollow organ  3 , and eventually releasing the purse string sutured tissue and lining from the applier  1 . 
         [0076]    In accordance with an embodiment, a suture feeder, e.g. a reel  33  of suture may be arranged inside the fastening assembly  4  and adapted to release the suture  17  through a feeding channel  32  which opens into the sewing groove  43 , preferably near a needle outlet aperture  35  at one of the fastening cavities  5 . In this way the needle  30  can be sent one or more times along the entire annular needle path  28  and through the acquired tissue and lining portions, while the required suture  17  is fed through the feeding channel  32  near a first entrance point of the suture  17  in the tissue and lining. 
         [0077]    Similar to the embodiment of  FIGS. 12 to 14 , also in the embodiment of  FIGS. 16 to 18  the fastening assembly  4  may comprise a side wall  34  which develops circumferentially about a longitudinal axis X. The fastening cavities  5  are formed in the side wall  34  and have each a circumferential extension with respect to the axis X and a longitudinal axial extension parallel to the longitudinal axis X, wherein the circumferential extension is preferably smaller than the axial extension. Each fastening cavity  5  can be delimited by a first sewing surface  10  and an opposite second sewing surface  12  which define a needle outlet aperture  35  (in the first sewing surface  10 ) and an opposite needle inlet aperture  36  (in the second sewing surface  12 ). The first and second sewing surfaces  10 ,  12  may be planar and parallel to the longitudinal axis X and may define planes which are radially oriented with respect to the longitudinal axis X. The needle path  28  may be circular and may extend coaxially and perpendicular to the longitudinal axis X of the fastening assembly  4 , whereas the sewing groove  43  may be provided as an externally open ring groove which encloses the needle path  28  and which intersects the sewing surfaces  10 ,  12  and the fastening cavity  5  at the needle outlet apertures  35  and needle inlet apertures  36 . 
         [0078]    Also in this embodiment, the suction apertures  8  may be formed in the sewing surfaces  10 ,  12  or, alternatively, the suction apertures  8  may open into the fastening cavities  5  from a radially internal side of the fastening cavities  5 , as illustrated in  FIGS. 16 and 17 . 
         [0079]    Also, the opposing sewing surfaces  10 ,  12  may be movable towards each other by a moving mechanism  37 . In accordance with an embodiment the opposing sewing surfaces  10 ,  12  are formed on two jaws  38  which are movable towards each other and away from each other for clamping the acquired tissue portions  6  and lining  2  before suturing, and for releasing the tissue portions and lining after completion of the suture. 
         [0080]    In the exemplary embodiment of  FIG. 16 , the jaws  38  are rotatable about an axis parallel to the longitudinal axis X or about the longitudinal axis X in order to improve the compatibility of the jaw movement and the circular needle path  28 . 
         [0081]    For the purpose of releasing the sutured tissue portion  6  and lining  2  from the fastening cavities, a pushing fluid, e.g. air or CO 2  or saline solution may be pumped through (a suction line connected with) the suction apertures  8  into the fastening cavities  5  or through a separate fluid feeding line with apertures opening into the fastening cavities  5 . 
         [0082]    Alternatively or additionally, the fastening assembly  4  may be radially expandable and/or retractable in a manner to stretch the suture circumferentially (while feeding suture into the stretching zone to avoid rupture of the suture) and/or to withdraw radially from the released sutured tissue and lining. A radially expansion of the fastening assembly can be e.g. obtained through a wedge mechanism adapted to drive a e.g. conical wedge slider between a plurality of circumferentially arranged expansion segments  44  of the fastening assembly  4 . 
         [0083]    The needle drive assembly  31  is adapted to move the needle  30  along the needle path  28 , release the needle  30  after having pushed the needle  30  out of the needle outlet aperture  35  into the fastening cavity  5 , and catch the needle  30  when it enters the needle inlet aperture  36 . For this purpose the needle drive assembly  31  may comprise a plurality of rotatable toothed gear wheels  39  or toothed sliders arranged along the needle path  28  and meshing with a toothed surface  40  of the needle  30 . The needle  30  itself may have a guide portion  41  which slidingly engages a guide  42  extending along the needle path  28  and adapted to guide and stabilize the needle  30  during its movement along the needle path  28 . 
         [0084]    In order not to hinder the removal of the applier  1  from the sutured tissue and lining, the length of the needle  30  may be such that the needle  30  can be stopped within at least one section of the fastening assembly  4  without protruding into a fastening cavity  5 . Alternatively, after releasing some of the tissue and lining portions from some of the fastening cavities  5  the needle  30  may be moved partially into an emptied fastening cavity  5 , thereby withdrawing from a previously partially occupied neighboring fastening cavity  5 . 
         [0085]      FIG. 19  illustrates a yet further method and device for securing a lining inside a hollow organ. A flexible endoluminal suturing device  45  with a rotatable and steerable shaft  46  and a distal clip applier  47  can be advanced through an instrument channel  48  of an endoscope  49  and is adapted to secure a lining in any desired section of the GI tract, e.g. at the esophagus, pylorus or duodenum. The clipping or suturing technique implemented by the device  45  may comprise also clipping and suturing techniques known from laparoscopic suturing devices. Thanks to the steerable shaft  46 , the device can comfortably apply a suture or clip along a 360° circumference of lumen and lining. Specifically, a flexible endoscope is transorally inserted through the mouth and esophagus into the stomach and from the stomach further through the pylorus into the duodenum up to a target section of small intestine to which the lining is intended to be secured. The lining is transported to the target section of intestine by the endoscope. For instance, the lining may be inserted over a distal portion of the endoscope and released (e.g. pushed distally away) from the endoscope after the latter has reached the target section of intestine. Alternatively, the lining may be fed through an instrument channel of the endoscope and expelled from the instrument channel at the distal end of the endoscope. After positioning a proximal anchoring portion of the lining within the target section of intestine, the flexible suturing device  45  with the rotatable and steerable shaft  46  and the distal clip applier  47  is passed through the instrument channel of the endoscope so that a rotatable and steerable distal end portion of the shaft  46  with the clip applier  47  protrudes outside the endoscope. Then the shaft  46  is bent laterally so that the clip applier  47  can engage the lining and the surrounding intestinal wall in a first securing point. By activating the clip applier  47 , the lining is secured to the intestinal wall in said first securing point. Subsequently, the clip applier  47  is recharged and prepared for the application of a further clip or suture. The rotatable and steerable shaft  46  is then rotated at a suitable angular pitch with respect to the first securing point and bent laterally (radially outward) to engage the lining and the surrounding tissue in a further securing point. The clip applier is again activated to apply a second clip or suture to the lining and tissue, thereby securing the lining also in the further securing point. The procedure can be repeated until the lining is secured to the surrounding tissue in a plurality of securing points along a circumference of the lining. After completion of the anchoring step, the distal end portion of the shaft is straightened and proximally withdrawn into the instrument channel of the endoscope. Then the entire suturing device  45  is withdrawn through the instrument channel of the endoscope and out of the patient&#39;s body. 
         [0086]      FIG. 20  illustrates a yet further method and device for securing a lining inside a hollow organ. A flexible endoluminal grasping device  50  with a grasper  51  adapted to create small folds  52  of tissue and lining is combined with a suturing device  53  adapted to apply a T-tag or to stitch a needle  30  with a suture thread  17  through the fold  52 . Also in this case the combined device is rotatable to reach any desirable position along a 360° perimeter of tissue lumen and lining. 
         [0087]    The lining  2  intended to form an endoluminal bypass conduit may be formed of any suitable biocompatible graft material such as polyester or PTFE, rubber, Teflon, Nylon, Dacron, polyethylene, polystyrene, polyurethane, polyethylene terephtalate, etc. In accordance with a further embodiment, both the lining  2  and the running suture could be bioabsorbable and adapted to completely dissolve over time. 
         [0088]    Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Technology Classification (CPC): 0