Abstract:
A fastener for use in fastening tissue layers in a mammalian body comprises a first member, a second member, and a connecting member fixed to each of the first and second members intermediate their ends and extending there between. One of the first and second members has a through channel along its axis arranged to be slidingly received on a tissue piercing deployment wire, and a slit extending between the first and second ends and communicating with the through channel. The connecting member includes an agent comprising a plurality of elongated fibers emanating from and carried by the connecting member that stimulates reaction of the tissue layers.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to tissue fixation devices. The present invention more particularly relates to tissue fixation devices which include agents that stimulate reactions, such as tissue reaction, for example, tissue growth, tissue healing, tissue scarring, and/or tissue adhesion, or anti-bacteria reactions. 
       BACKGROUND 
       [0002]    Tissue fixation devices or fasteners find many different uses. One use for such a device is in the treatment of GastroEsophageal Reflux Disease (GERD). 
         [0003]    GERD is a chronic condition caused by the failure of the anti-reflux barrier located at the gastroesophageal junction to keep the contents of the stomach from splashing into the esophagus. The splashing is known as gastroesophageal reflux. The stomach acid is designed to digest meat, and will digest esophageal tissue when persistently splashed into the esophagus. 
         [0004]    A principal reason for regurgitation associated with GERD is the mechanical failure of a deteriorated gastroesophageal flap to close and seal against high pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap may deteriorate into a malfunctioning Grade III or absent valve Grade IV. With a deteriorated gastroesophageal flap, the stomach contents are more likely to be regurgitated into the esophagus, the mouth, and even the lungs. The regurgitation is referred to as “heartburn” because the most common symptom is a burning discomfort in the chest under the breastbone. Burning discomfort in the chest and regurgitation (burping up) of sour-tasting and/or bitter-tasting gastric juice into the mouth are classic symptoms of gastroesophageal reflux disease (GERD). When stomach acid is regurgitated into the esophagus, it is usually cleared quickly by esophageal contractions. Heartburn (backwashing of stomach acid and bile onto the esophagus) results when stomach acid is frequently regurgitated into the esophagus and the esophageal wall is inflamed. 
         [0005]    Complications develop for some people who have GERD. Esophagitis (inflammation of the esophagus) with erosions and ulcerations (breaks in the lining of the esophagus) can occur from repeated and prolonged acid exposure. If these breaks are deep, bleeding or scarring of the esophagus with formation of a stricture (narrowing of the esophagus) can occur. If the esophagus narrows significantly, then food sticks in the esophagus and the symptom is known as dysphagia. GERD has been shown to be one of the most important risk factors for the development of esophageal adenocarcinoma. In a subset of people who have severe GERD, if acid exposure continues, the injured squamous lining is replaced by a precancerous lining (called Barrett&#39;s Esophagus) in which a cancerous esophageal adenocarcinoma can develop. 
         [0006]    Other complications of GERD may not appear to be related to esophageal disease at all. Some people with GERD may develop recurrent pneumonia (lung infection), asthma (wheezing), or a chronic cough from acid backing up into the esophagus and all the way up through the upper esophageal sphincter into the lungs. In many instances, this occurs at night, while the person is in a supine position and sleeping. Occasionally, a person with severe GERD will be awakened from sleep with a choking sensation. Hoarseness can also occur due to acid reaching the vocal cords, causing a chronic inflammation or injury. 
         [0007]    GERD never improves without intervention. Life style changes combined with both medical and surgical treatments exist for GERD. Medical therapies include antacids and proton pump inhibitors. However, the medical therapies only mask the reflux. Patients still get reflux and perhaps emphysema because of particles refluxed into the lungs. Barrett&#39;s esophagus results in about 10% of the GERD cases. The esophageal epithelium changes into tissue that tends to become cancerous from repeated acid washing despite the medication. 
         [0008]    Several open laparotomy and laparoscopic surgical procedures are available for treating GERD. One surgical approach is the Nissen fundoplication. The Nissen approach typically involves a 360-degree wrap of the fundus around the gastroesophageal junction. The procedure has a high incidence of postoperative complications. The Nissen approach creates a 360-degree moveable flap without a fixed portion. Hence, Nissen does not restore the normal movable flap. The patient cannot burp because the fundus was used to make the repair, and may frequently experience dysphagia. Another surgical approach to treating GERD is the Belsey Mark IV (Belsey) fundoplication. The Belsey procedure involves creating a valve by suturing a portion of the stomach to an anterior surface of the esophagus. It reduces some of the postoperative complications encountered with the Nissen fundoplication, but still does not restore the normal movable flap. None of these procedures fully restores the normal anatomical anatomy or produces a normally functioning gastroesophageal junction. 
         [0009]    Another surgical approach is the Hill repair. In the Hill repair, the gastroesophageal junction is anchored to the posterior abdominal areas, and a 180-degree valve is created by a system of sutures. The Hill procedure restores the moveable flap, the cardiac notch and the Angle of His. However, all of these surgical procedures are very invasive, regardless of whether done as a laparoscopic or an open procedure. 
         [0010]    New, less surgically invasive approaches to treating GERD involve transoral endoscopic procedures. One procedure contemplates a machine device with robotic arms that is inserted transorally into the stomach. While observing through an endoscope, an endoscopist guides the machine within the stomach to engage a portion of the fundus with a corkscrew-like device on one arm. The arm then pulls on the engaged portion to create a fold of tissue or radial plication at the gastroesophageal junction. Another arm of the machine pinches the excess tissue together and fastens the excess tissue with one pre-tied implant. This procedure does not restore normal anatomy. The fold created does not have anything in common with a valve. In fact, the direction of the radial fold prevents the fold or plication from acting as a flap of a valve. 
         [0011]    Another transoral procedure contemplates making a fold of fundus tissue near the deteriorated gastroesophageal flap to recreate the lower esophageal sphincter (LES). The procedure requires placing multiple U-shaped tissue clips around the folded fundus to hold it in shape and in place. 
         [0012]    This and the previously discussed procedure are both highly dependent on the skill, experience, aggressiveness, and courage of the endoscopist. In addition, these and other procedures may involve esophageal tissue in the repair. Esophageal tissue is fragile and weak, in part due to the fact, that the esophagus is not covered by serosa, a layer of very sturdy, yet very thin tissue, covering and stabilizing all intraabdominal organs, similar like a fascia covering and stabilizing muscle. Involvement of esophageal tissue in the repair of a gastroesophageal flap valve poses unnecessary risks to the patient, such as an increased risk of fistulas between the esophagus and the stomach. 
         [0013]    A new and improved apparatus and method for restoration of a gastroesophageal flap valve is fully disclosed in U.S. Pat. No. 6,790,214 which issued on Sep. 14, 2004, on an application filed May 17, 2002, for TRANSORAL ENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE, ASSEMBLY, SYSTEM AND METHOD, which is assigned to the assignee of this invention, and which is incorporated herein by reference. That apparatus and method provides a transoral endoscopic gastroesophageal flap valve restoration. A longitudinal member arranged for transoral placement into a stomach carries a tissue shaper that non-invasively grips and shapes stomach tissue. A tissue fixation device is then deployed to maintain the shaped stomach tissue in a shape approximating a gastroesophageal flap. 
         [0014]    Whenever tissue is to be maintained in a shape as, for example, in the improved assembly last mentioned above, it is necessary to fasten at least two layers of tissue together. Once the tissue layers are fastened together, it is intended that the tissue layers adhere together. Some tissue combinations rarely exhibit adherence. Other tissue or tissue combinations eventually do adhere together but at varying rates. Generally, it is desired for the adherence to occur as quickly as possible. Further, some tissue and tissue combinations will be punctured or otherwise injured during the fastener deployment process. In these cases, it is desirable that the fastened tissue also heal and seal punctures that may be formed. Sometimes, the healing reaction process promotes tissue adhesion. Other tissue reactions that promote tissue adhesion include scarring and growth. 
         [0015]    The present invention, in its broader aspects, addresses the issues of tissue or bacterial reactions following tissue fastening. Accordingly, as will be seen hereinafter, the various embodiments are directed to tissue fasteners including agents to promote tissue reactions such as, for example, growth, healing, sealing, scarring, fusion, and adhesion. 
       SUMMARY 
       [0016]    The invention provides a fastener arranged to secure at least two tissue layers together. The fastener comprises a first anchor member, a second anchor member, and a penetrating member connected to the first and second anchor members that penetrates the at least two tissue layers such that the first and second anchor members engage outermost surfaces of the at least two tissue layers with the penetrating member extending through the at least two tissue layers from the first anchor member to the second anchor member. The penetrating member includes an agent that stimulates a reaction at the at least two tissue layers. 
         [0017]    The agent is arranged to stimulate a reaction of the tissue layers. The reactions may include at least one of growth, healing, sealing, scarring, fusion, and adhesion. The agent may include an antibiotic. 
         [0018]    The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member. The elongated fibers may be formed of one of silk, polyester, and polypropylene, and other natural and synthetic materials promoting controlled tissue reactions. The plurality of fibers may also be configured in loops. The elongated fibers may be arranged on the penetrating member such that at least some of the elongated fibers are between the at least two tissue layers when the fastener is deployed. The elongated fibers may further be biodegradable. 
         [0019]    The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member. The fibers may include a substance that elutes from the elongated fibers to stimulate reaction of the at least two tissue layers. The substance may be one of a powder and a coating. 
         [0020]    The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member, the elongated fibers carrying a substance that stimulates the reaction. The substance may be one of a powder and a coating. 
         [0021]    The first and second anchor members may have first and second ends. The penetrating member maybe fixed to each of the first and second anchor members intermediate the first and second ends and extend between the first and second members. One of the first and second anchor members may have a longitudinal axis and a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire. The one of the first and second anchor members may have a slit extending between the first and second ends and communicating with the through channel. 
         [0022]    The agent may be arranged to stimulate a reaction of the tissue layers including at least one of growth, healing, scarring, and adhesion. The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member. The plurality of fibers may be configured in loops. The elongated fibers may be formed of one of silk, polyester, and polypropylene, and other natural and synthetic materials promoting controlled tissue reactions. The elongated fibers may be arranged on the penetrating member such that at least some of the elongated fibers are between the at least two tissue layers. The elongated fibers may be biodegradable. The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member, the fibers including a substance that elutes from the elongated fibers to stimulate reaction of the at least two tissue layers. The eluting substance may be one of a powder and a coating. The agent may comprise a plurality of elongated fibers emanating from and carried by the penetrating member, the elongated fibers carrying a substance that stimulates the reaction. The substance may be one of a powder and a coating. The agent may be one of a powder and a coating. 
         [0023]    In another embodiment, a fastener for use in fastening at least two tissue layers in a mammalian body comprises a first member, a second member, wherein the first and second members have first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first and second members are separated by the connecting member. One of the first and second members has a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire and a slit extending between the first and second ends and communicating with the through channel. The connecting member includes an agent that stimulates a reaction at the at least two tissue layers. 
         [0024]    In a further embodiment, a fastener for use in fastening tissue layers in a mammalian body comprises a first member and a second member. The first and second members have first and second ends. A connecting member is fixed to each of the first and second members intermediate the first and second ends and extends between the first and second members. The first and second members are separated by the connecting member. One of the first and second members has a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire, and a slit extending between the first and second ends that communicates with the through channel. The connecting member includes an agent comprising a plurality of elongated fibers emanating from and carried by the connecting member that stimulates reaction of the tissue layers. The fastener and agent may both be absorbable/bio-degradable. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like elements, and wherein: 
           [0026]      FIG. 1  is a front cross-sectional view of the esophago-gastro-intestinal tract from a lower portion of the esophagus to the duodenum; 
           [0027]      FIG. 2  is a front cross-sectional view of the esophago-gastro-intestinal tract illustrating a Grade I normal appearance movable flap of the gastroesophageal valve (in dashed lines) and a Grade III reflux appearance gastroesophageal flap of the gastroesophageal valve (in solid lines); 
           [0028]      FIG. 3  is an end plan view of a fastener embodying the present invention; 
           [0029]      FIG. 4  is a side plan view of the fastener of  FIG. 3 ; 
           [0030]      FIG. 5  is a side view, with portions cut away, of the fastener  FIG. 3  being delivered for deployment; 
           [0031]      FIG. 6  is a side view, with portions cut away of the fastener of  FIG. 3  after having been deployed; 
           [0032]      FIG. 7  is an end plan view of another embodiment of the present invention; 
           [0033]      FIG. 8  is a side plan view of the fastener of  FIG. 7 ; 
           [0034]      FIG. 9  is a side view, with portions cut away of the fastener of  FIG. 7  being delivered for deployment; 
           [0035]      FIG. 10  is a side view, with portions cut away, of the fastener of  FIG. 7  after having been deployed; 
           [0036]      FIG. 11  is an end plan view of another embodiment of the present invention; 
           [0037]      FIG. 12  is a side plan view of the fastener of  FIG. 11 ; 
           [0038]      FIG. 13  is a side view, with portions cut away of the fastener of  FIG. 11  being delivered for deployment; and 
           [0039]      FIG. 14  is a side view, with portions cut away, of the fastener of  FIG. 11  after having been deployed; and 
           [0040]      FIG. 15  is a perspective view, with portions cut away, of a restored GEF being secured by fasteners embodying the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]      FIG. 1  is a front cross-sectional view of the esophageal-gastro-intestinal tract  40  from a lower portion of the esophagus  41  to the duodenum  42 . The stomach  43  is characterized by the greater curvature  44  on the anatomical left side and the lesser curvature  45  on the anatomical right side. The tissue of the outer surfaces of those curvatures is referred to in the art as serosa tissue. As will be seen subsequently, the nature of the serosa tissue is used to advantage for its ability to bond to like serosa tissue. The fundus  46  of the greater curvature  44  forms the superior portion of the stomach  43 , and traps gas and air bubbles. The esophageal tract  41  enters the stomach  43  at an esophageal orifice below the superior portion of the fundus  46 , forming a cardiac notch  47  and an acute angle with respect to the fundus  46  known as the Angle of His  57 . The lower esophageal sphincter (LES)  48  is a discriminating sphincter able to distinguish between burping gas, liquids, and solids, and works in conjunction with the fundus  46  to burp. The gastroesophageal valve (GEV)  49  includes a moveable portion and an opposing more stationary portion. The moveable portion of the GEV  49  is an approximately 180 degree, semicircular, gastroesophageal flap  50  (alternatively referred to as a “normal moveable flap” or “moveable flap”) formed of tissue at the intersection between the esophagus  41  and the stomach  43 . The opposing more stationary portion of the GEV  49  comprises a portion of the lesser curvature  45  of the stomach  43  adjacent to its junction with the esophagus  41 . The gastroesophageal flap  50  of the GEV  49  principally comprises tissue adjacent to the fundus  46  portion of the stomach  43 , is about 4 to 5 cm long ( 51 ) at it longest portion, and the length may taper at its anterior and posterior ends. The gastroesophageal flap  50  is partially held against the lesser curvature  45  portion of the stomach  43  by the pressure differential between the stomach  43  and the thorax, and partially by the resiliency and the anatomical structure of the GEV  49 , thus providing the valving function. The GEV  49  is similar to a flutter valve, with the gastroesophageal flap  50  being flexible and closeable against the other more stationary side. 
         [0042]    The esophageal tract is controlled by an upper esophageal sphincter (UES) in the neck near the mouth for swallowing, and by the LES  48  and the GEV  49  at the stomach. The normal anti-reflux barrier is primarily formed by the LES  48  and the GEV  49  acting in concert to allow food and liquid to enter the stomach, and to considerably resist reflux of stomach contents into the esophagus  41  past the gastroesophageal tissue junction  52 . Tissue aboral of the gastroesophageal tissue junction  52  is generally considered part of the stomach because the tissue protected from stomach acid by its own protective mechanisms. Tissue oral of the gastroesophageal junction  52  is generally considered part of the esophagus and it is not protected from injury by prolonged exposure to stomach acid. At the gastroesophageal junction  52 , the juncture of the stomach and esophageal tissues form a zigzag line, which is sometimes referred to as the “Z-line.” For the purposes of these specifications, including the claims, “stomach” means the tissue aboral of the gastroesophageal junction  52 . 
         [0043]      FIG. 2  is a front cross-sectional view of an esophago-gastro-intestinal tract illustrating a Grade I normal appearance movable flap  50  of the GEV  49  (shown in dashed lines) and a deteriorated Grade III gastroesophageal flap  55  of the GEV  49  (shown in solid lines). As previously mentioned, a principal reason for regurgitation associated with GERD is the mechanical failure of the deteriorated (or reflux appearance) gastroesophageal flap  55  of the GEV  49  to close and seal against the higher pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap  50  of the GEV  49  may deteriorate into a Grade III deteriorated gastroesophageal flap  55 . The anatomical results of the deterioration include moving a portion of the esophagus  41  that includes the gastroesophageal junction  52  and LES  48  toward the mouth, straightening of the cardiac notch  47 , and increasing the Angle of His  57 . This effectively reshapes the anatomy aboral of the gastroesophageal junction  52  and forms a flattened fundus  56 . The deteriorated gastroesophageal flap  55  illustrates a gastroesophageal flap valve  49  and cardiac notch  47  that have both significantly degraded. Dr. Hill and colleagues developed a grading system to describe the appearance of the GEV and the likelihood that a patient will experience chronic acid reflux. L. D. Hill, et al.,  The gastroesophageal flap valve: in vitro and in vivo observations , Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill&#39;s grading system, the normal movable flap  50  of the GEV  49  illustrates a Grade I flap valve that is the least likely to experience reflux. The deteriorated gastroesophageal flap  55  of the GEV  49  illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flap valve is the most likely to experience reflux. Grades II and III reflect intermediate grades of deterioration and, as in the case of III, a high likelihood of experiencing reflux. With the deteriorated GEV represented by deteriorated gastroesophageal flap  55  and the fundus  46  moved inferior, the stomach contents are presented a funnel-like opening directing the contents into the esophagus  41  and the greatest likelihood of experiencing reflux. Disclosed subsequently are fasteners and assemblies which may be employed to advantage in restoring the normal gastroesophageal valve anatomy. 
         [0044]      FIG. 3  is an end plan view and  FIG. 4  is a side plan view of a fastener  100  embodying the present invention. The fastener  100  generally includes a first anchor member  102 , a second anchor member  104 , and a penetrating member  106 . As may be noted in  FIG. 3 , the first anchor member  102  and second anchor member  104  are substantially parallel to each other and substantially perpendicular to the penetrating member  106  which connects the first anchor member  102  to the second anchor member  104 . Parts or all of the fasteners may be absorbable. 
         [0045]    The first anchor member  102  is generally cylindrical or can have any other shape. It has a longitudinal axis  108  and a through channel  112  along the longitudinal axis  108 . The through channel  112  is formed by a through bore which is dimensioned to be slidingly received on a tissue piercing deployment wire to be described. 
         [0046]    The first anchor member  102  also includes a first end  116  and a second end  118 . Similarly, the second anchor member  104  includes a first end  120  and a second end  122 . The first end  116  of member  102  forms a pointed dilation tip  124 . The dilation tip  124  may be conical and more particularly takes the shape of a truncated cone. The tip can also be shaped to have a cutting edge in order to reduce tissue resistance. It may also have a “ski-tip” or other directing configurations. 
         [0047]    The first and second anchor members  102  and  104  and the penetrating member  106  may be formed of different materials and have different textures. These materials may include, for example, plastic materials such as polypropylene, polyethylene, polyglycolic acid, polyurethane, or a thermoplastic elastomer. The plastic materials may include a pigment contrasting with body tissue color to enable better visualization of the fastener during its deployment. Alternatively, the fastener may be formed of a metal, such as stainless steel or a shape memory metal, such as Nitinol or a shape memory plastic. The fasteners may also contain radio opaque substances and parts. 
         [0048]    As may be further noted in  FIGS. 3 and 4 , the penetrating member  106  has a vertical dimension  128  and a horizontal dimension  130  which is transverse to the vertical dimension. The horizontal dimension is substantially less than the vertical dimension to render the penetrating member  106  readily bendable in a horizontal plane. The penetrating member is further rendered bendable by the nature of the material from which the fastener  100  is formed. The penetrating member may be formed from either an elastic plastic or a permanently deformable plastic. An elastic material would prevent compression necrosis in some applications. 
         [0049]    It may be noted in  FIGS. 3 and 4 , that the first anchor member  102  has a continuous lengthwise slit  125  extending between the first and second ends  116  and  118 . The slit  125  communications with the through channel  112 . Also, because the first anchor member  102  is formed of flexible material, the slit  125  may be made larger through separation to allow the deployment wire to be snapped into and released from the through channel  112 . This permits ready release of the first anchor member  102  during deployment and decreases compression on the tissue layers. For a complete description of a manner in which the fastener  100  may be deployed to obtain quick release of the fastener from the tissue piercing deployment wire, reference may be had to co-pending U.S. application Ser. No. 11/043,903 filed on Jan. 25, 2005, titled SLITTED TISSUE FIXATION DEVICES AND ASSEMBLIES FOR DEPLOYING THE SAME, and which is incorporated herein by reference. The slit  125  extends substantially parallel to the through channel  112  and the center axis  108  of the first anchor member  102 . The slit  125  has a width dimension that is smaller or less than the diameter of the through channel  112 . This assures that the fastener  100  will remain on a tissue piercing deployment wire as it is pushed towards and into the tissue during deployment. 
         [0050]    With continued reference to  FIGS. 3 and 4 , and in accordance with this embodiment of the present invention, the device  100  further includes an agent  121  that promotes tissue reaction after the fastener is deployed. The tissue reaction may include any one or combination of growth, scarring, healing, sealing, fusion, and adhesion. 
         [0051]    The agent  121 , in accordance with this embodiment, comprises a plurality of elongated fibers  123 . The fibers may be formed of silk, polyester, polypropylene, carbon, nylon, and/or a biodegradable material such as polyglycolic acid, polyglactin or polydioxanone. Alternatively, the fibers may include, by being formed from or carrying, a substance that elutes into the tissue after deployment to stimulate tissue reaction(s). Such substances may be calcium alginate, sodium alginate, corn starch, talc, latex, and a human growth hormone, such as somatropin, for example. To carry the substances that promote tissue reaction, the substances may form a coating on the fibers  123  either in a continuous form or a powder form. Substances which may form a continuous coating include calcium alginate gel, sodium alginate, and collagen for example. Substances which may be carried by the fibers in powered form include corn starch, glove powder, and silver, for example. Other materials that may be employed include healing agents such as antibiotics, as for example, vancomycin, or tissue adhesives, such as fibrin. 
         [0052]    The fibers may be attached to the fastener  100  by being attached, for example, to the penetrating member  106 , in accordance with this embodiment. The fibers may be attached to the penetrating member  106  by tying, by trapping them in a slit made in the penetrating member, by melting a portion of the penetrating member about the fibers, or by adhesion with an adhesive. Other forms of attachment are possible. 
         [0053]    Either one or both of the fastener and the fibers may be biodegradable. In some cases, it may be preferable to have the fastener be biodegradable and the fibers prevalent. 
         [0054]    Alternatively, the agent may not require the fibers  123  and instead simply be a substance formed in the fastener or a substance carried on the fastener  100  without the fibers  121 . However, inclusion of the fibers is advantageous because they present an increased surface area to the fastened tissue to accelerate the tissue reaction process. Other forms of surface area enhancement are also possible. The use of fibers, however, is particularly advantageous because they can be readily tucked away so as to not interfere with the fastener deployment process as will be seen in  FIG. 5 . 
         [0055]    Referring now to  FIG. 5 , it is a perspective view with portions cut away of a fastener assembly  200  for deploying the fastener  100 . The assembly  200  generally includes a stylet or tissue piercing deployment wire  204 , a pusher  206 , and a guide channel or tube  202 . 
         [0056]    The first anchor member  102  of the fastener  100  is slidingly received on the deployment wire  204 . The deployment wire  204  has a pointed tip  208  for piercing the tissue layers  280  and  282  ( FIG. 6 ) to be fastened together. As will be further noted in  FIG. 5 , the second anchor member  104  is disposed along side the first anchor member  102 . This is rendered possible by the flexibility and configuration of the penetrating member  106 . The fibers  123  are tucked in the guide channel and extend along side the penetrating member  106 . The fastener  100  is now ready for deployment. It may be deployed as fully described in the aforementioned co-pending application Ser. No. 11/043,903. 
         [0057]    When the fastener is fully deployed, the first anchor member  102  and second anchor member  104  engage the outermost or innermost surfaces  283  and  281  respectively of the tissue layers  282  and  280  respectively with the penetrating member  106  extending through the tissue there between. This may be seen in  FIG. 6 . Here it may be seen that the first anchor member  102  is adjacent outer surface  283  of the tissue layer  282 , the second anchor member  104  is adjacent outer surface  281  of the tissue layer  281 , and that the penetrating member  206  extends between the tissue layers. The fibers  123  fill in the tissue penetration path or between the tissue layers in broad surface area contact therewith to stimulate reaction of the fastened tissue as previously described. 
         [0058]      FIG. 7  is an end plan view and  FIG. 8  is a side plan view of another fastener  300  embodying the present invention. The fastener  300 , as in the previous embodiment, generally includes a first anchor member  302 , a second anchor member  304 , and a penetrating member  306 . As may be noted in  FIG. 7 , the first anchor member  302  and second anchor member  304  are substantially parallel to each other and substantially perpendicular to the penetrating member  306  which connects the first anchor member  302  to the second anchor member  304 . 
         [0059]    The first anchor member  302  is again generally cylindrical. It has a longitudinal axis  308  and a through channel  312  along the longitudinal axis  308 . The through channel  312  is formed by a through bore which is dimensioned to be slidingly received on the tissue piercing deployment wire. 
         [0060]    The first anchor member  302  also includes a first end  316  and a second end  318 . Similarly, the second anchor member  304  includes a first end  320  and a second end  322 . The first end  316  of member  302  forms a pointed dilation tip  324 . The dilation tip  324  again may be conical or shaped otherwise and more particularly take the shape of a truncated cone. 
         [0061]    The first and second anchor members  302  and  304  and the penetrating member  306  may be formed of any of the different materials and have the different textures previously described. As in the embodiment of  FIGS. 3 and 4 , the penetrating member  306  has a horizontal dimension that is substantially less than its vertical dimension to render the penetrating member  306  readily bendable. The penetrating member is further rendered bendable by the nature of the material from which the fastener  300  is formed. 
         [0062]    The first anchor member  302  has a continuous lengthwise slit  325  extending between the first and second ends  316  and  318 . The slit  325  communicates with the through channel  312 . Also, as in the previous embodiment, the slit  125  may be made larger through separation to allow the deployment wire to be snapped into and released from the through channel  312 . This permits ready release of the first anchor member  302  during deployment and decreases compression on the tissue layers. As in the previous embodiment, the fastener  300  may be deployed as described in copending U.S. application Ser. No. 11/043,903. 
         [0063]    With continued reference to  FIGS. 7 and 8 , and in accordance with this embodiment of the present invention, the device  300  further includes an agent  321  that promotes tissue reaction or serves as tissue glue after the fastener is deployed. Again, the tissue reaction may include any one or combination of growth, scarring, healing, fusion, and adhesion. 
         [0064]    The agent  121 , in accordance with this embodiment, comprises a plurality of elongated fibers  323  positioned substantially at the midpoint between the first anchor member  302  and the second anchor member  304 . This permits the fibers to fill in between the fastened tissue layers and/or the fastener path while allowing the fibers to be shorter in length. The fibers may be formed of any of the substances and have any of the characteristics previously described with respect to the embodiment of  FIGS. 3 and 4 . The fibers may also be attached to the penetrating member  306  by tying, by trapping them in a slit made in the penetrating member, by melting a portion of the penetrating member about the fibers, or by adhesion with an adhesive. 
         [0065]      FIG. 9 , is a perspective view with portions cut away of the fastener assembly  200  delivering the fastener  300  for deployment. The first anchor member  302  of the fastener  300  is slidingly received on the deployment wire  204 . The fibers  323  also extend along side the penetrating member  306 . The fastener may now be deployed in a manner as fully described in the aforementioned co-pending application Ser. No. 11/043,903. 
         [0066]      FIG. 10  shows the fastener  300  fully deployed. The first anchor member  302  and second anchor member  304  engage the outer surfaces  283  and  281  of the tissue layers  282  and  280  respectively with the penetrating member  306  extending through the tissue there between. The fibers  323  fill in between the tissue layers in broad surface area contact therewith to stimulate reaction of the fastened tissue as previously described. 
         [0067]      FIG. 11  is an end plan view and  FIG. 12  is a side plan view of still another fastener  400  embodying the present invention. The fastener  400 , as in the previous embodiments, generally includes a first anchor member  402 , a second anchor member  404 , and a penetrating member  406 . As may be noted in  FIG. 12 , the first anchor member  402  and second anchor member  404  are substantially parallel to each other and substantially perpendicular to the penetrating member  406  which connects the first anchor member  402  to the second anchor member  404 . The fastener may be formed of any of the materials previously described with respect to fasteners  100  and  300  and may be similarly configured. 
         [0068]    In accordance with this embodiment of the present invention, the agent  421  to promote tissue reaction after the fastener is deployed takes the form of a plurality of fiber loops  423 . The fiber loops not only promote tissue reaction such as any one or combination of growth, scarring, healing, fusion, and adhesion, but in addition, promote attachment of ingrown tissue. 
         [0069]    The fiber loops  423  are positioned substantially at the midpoint between the first anchor member  402  and the second anchor member  404 . This again positions the fibers for filling in between the fastened tissue layers. The fiber loops may be formed of any of the substances and have any of the characteristics previously described with respect to the previous embodiments. The fiber loops may also be attached to the penetrating member  406  by tying, by trapping them in a slit made in the penetrating member, by melting a portion of the penetrating member about the fibers, or by adhesion with an adhesive. 
         [0070]      FIG. 13 , is a perspective view with portions cut away of the fastener assembly  200  delivering the fastener  400  for deployment. The first anchor member  402  of the fastener  400  is slidingly received on the deployment wire  204 . The fiber loops  423  also extend along side the penetrating member  406 . The fastener may now be deployed in a manner as fully described in the aforementioned co-pending application Ser. No. 11/043,903. 
         [0071]      FIG. 14  shows the fastener  400  fully deployed. The first anchor member  402  and second anchor member  404  engage the outer or inner surfaces  283  and  281  of the tissue layers  282  and  280  respectively with the penetrating member  406  extending through the tissue there between. The fiber loops  423  fill in between the tissue layers in broad surface area contact therewith to stimulate reaction of the fastened tissue and attachment of ingrowing tissue as previously described. 
         [0072]      FIG. 15  shows a restored GEF  149 . The GEF may be restored by practicing the method fully described in co-pending U.S. application Ser. No. 11/172,427, filed Jun. 29, 2005 for APPARATUS AND METHOD FOR MANIPULATING STOMACH TISSUE AND TREATING GASTROESOPHAGEAL REFLUX DISEASE, incorporated herein by reference. The GEF  149  may be maintained by a plurality of fasteners embodying the present invention. More specifically, as may be noted in  FIG. 15 , the restored GEF  149  is being maintained by fasteners  400  having fiber loops  423  to promote reaction of the fastened stomach tissue. 
         [0073]    While the invention has been described by means of specific embodiments and applications thereof, it is understood that numerous modifications and variations may be made thereto by those skilled in the art without departing from the spirit and scope of the invention. It is therefore to be understood that within the scope of the claims, the invention may be practiced otherwise than as specifically described herein.