US20040044364A1 - Tissue fasteners and related deployment systems and methods - Google Patents

Abstract

Surgical tissue fasteners and related deployment systems and methods are disclosed. A tissue fastener used to join multiple tissue layers includes a first member, a second member, and a connecting member connecting the first and second members. In some embodiments, the first and second members are configured to expand from a delivered state to a deployed state in which the fastener secures the tissue layers together. Other tissue fastener embodiments include means for applying a substantially constant force on the tissue layers and/or means for adjusting a length of the connecting member between the first and second members.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application relates to commonly assigned U.S. Application Serial No. ______ of Robert Devries et al., filed on the same date as this application, and entitled “Devices and Methods for Fastening Tissue Layers.” The complete disclosure of that application is incorporated by reference herein.[0001]
DESCRIPTION OF THE INVENTION
• 2. 1Field of the Invention[0002]
• The present invention relates to surgical tissue fasteners and related deployment systems and methods for delivering the tissue fasteners. In particular, the present invention relates to tissue fasteners used in, for example, a fundoplication procedure for treatment of Gastroesophageal Reflux Disease (GERD).[0003]
• 2. Background of the Invention[0004]
• Gastroesophageal reflux occurs when stomach acid enters the esophagus. This reflux of acid into the esophagus occurs naturally in healthy individuals, but also may become a pathological condition in others. Effects from gastroesophageal reflux range from mild to severe. Mild effects include heartburn, a burning sensation experienced behind the breastbone. More severe effects include a variety of complications, such as esophageal erosion, esophageal ulcers, esophageal stricture, abnormal epithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration. These various clinical conditions and changes in tissue structure that result from reflux of stomach acid into the esophagus are referred to generally as Gastroesophageal Reflux Disease (GERD).[0005]
• Many mechanisms contribute to prevent gastroesophageal reflux in healthy individuals. One such mechanism is the functioning of the lower esophageal sphincter (LES). With reference to FIG. 1, the[0006]LES2 is a ring of smooth muscle and increased annular thickness existing in approximately the last four centimeters of the esophagus. In its resting state, the LES creates a region of high pressure (approximately 15-30 mm Hg above intragastric pressure) at the opening of theesophagus3 into thestomach7. This pressure essentially closes theesophagus3 so that contents of the stomach cannot pass back into theesophagus3. TheLES2 opens in response to swallowing and peristaltic motion in theesophagus3, allowing food to pass into the stomach. After opening, however, a properly functioningLES2 should return to the resting, or closed state. Transient relaxations of theLES2 do occur in healthy individuals, typically resulting in occasional bouts of heartburn.
• The physical interaction occurring between the[0007]gastric fundus5 and theesophagus3 also prevents gastroesophageal reflux. Thegastric fundus5 is a lobe of the stomach situated at the top of thestomach7 distal to theesophagus3. In asymptomatic individuals, thefundus5 presses against the opening of theesophagus3 when thestomach7 is full of food and/or gas. This effectively closes off the esophageal opening to thestomach7 and helps to prevent acid reflux back into theesophagus3. More specifically, as the food bolus is immersed in gastric acid, it releases gas which causes thefundus5 of thestomach7 to expand and thereby exert pressure on thedistal esophagus3 causing it to collapse. The collapse of the esophagus lumen reduces the space for the stomach acid to splash past the closed esophagus lumen and thereby protect the proximal esophagus from its destructive contact.
• In individuals with GERD, the[0008]LES2 functions abnormally, either due to an increase in transient LES relaxations, decreased muscle tone of theLES2 during resting, or an inability of the esophageal tissue to resist injury or repair itself after injury. These conditions often are exacerbated by overeating, intake of caffeine, chocolate or fatty foods, smoking, and/or hiatal hernia. Avoiding these exacerbating mechanisms helps curb the negative side effects associated with GERD, but does not change the underlying disease mechanism.
• A surgical procedure, known generally as fundoplication, has been developed to prevent acid reflux in patients whose normal LES functioning has been impaired, either as a result of GERD or other adverse effects. This procedure involves bringing the[0009]fundus wall6 into closer proximity of theesophageal wall4 to help close off the esophageal opening into thestomach7. Traditionally, this procedure has been performed as an open surgery, but also has been performed laparoscopically.
• As with any surgery, the attendant risks are great. Due to relatively large incisions necessary in the performance of open surgery, relatively large amount of blood is lost, the risk of infection increases, and the potential for post-operative hernias is high. Further, the relatively large incisions necessary in the performance of open surgery require extended recovery times for the incision to heal.[0010]
• A laparoscopic procedure may involve performing laparotomies for trocar ports (penetrations of the abdominal wall), percutaneous endoscopic gastronomies (incisions through the skin into the stomach), and the installation of ports through which, for example, a stapler, an endoscope, and an esophageal manipulator (invagination device) are inserted. Under view of the endoscope, the esophageal manipulator is used to pull the interior of the[0011]esophagus3 into thestomach7. When the esophagus is in position, with thefundus5 of the stomach plicated, the stapler is moved into position around the lower end of the esophagus and the plicated fundus is stapled to theesophagus3. The process may be repeated at different axial and rotary positions until the desired fundoplication is achieved. This procedure is still relatively invasive requiring incisions through the stomach, which has a risk of infection. The location of the incision in the abdominal wall presents a risk of other negative effects, such as sepsis, which can be caused by leakage of septic fluid contained in the stomach.
SUMMARY OF THE INVENTION
• Therefore, one embodiment of the present invention provides less invasive devices and methods for performing the fundoplication procedure. This is achieved by utilizing tissue fasteners and related deployment systems which can be endoluminally delivered through the[0012]esophagus3, thereby eliminating the need for highly invasive, physiologically insulting surgical procedures.
• To attain the advantages and in accordance with the purpose of the invention, as embedded and broadly described herein, one aspect of the invention provides a tissue fastener used to join multiple tissue layers. The tissue fastener includes a proximal member configured to expand from a delivered state to a deployed state, a distal member configured to expand from a delivered state to a deployed state, and a connecting member connecting the proximal member to the distal member. In the deployed state, the proximal member and the distal member secure the multiple tissue layers together.[0013]
• Another aspect of the invention provides a tissue fastener used to join multiple tissue layers that includes a first member, a second member, a connecting member connecting the first member to the second member, and means for applying a substantially constant force on the tissue layers. In some embodiments, the applying means may be compressible.[0014]
• Another aspect of the invention provides a tissue fastener used to join multiple tissue layers that includes a first member, a second member, a connecting member connecting the first member to the second member, and means for adjusting a length of the connecting member between the first and second members. In some embodiments, the adjusting means may include structure associated with the first member for releasably securing the connecting member to the first member. That structure may be configured to restrict passage of the connecting member in a direction through the first member.[0015]
• Another aspect of the present invention is to provide a delivery system configured for deployment of an expandable tissue fastener. The system includes a flexible tube configured to accommodate a tissue fastener in a contracted state, a pusher for guiding the tissue fastener along a lumen of the tube, and a grasper coupled to a distal end of the pusher and having means to grasp the tissue fastener.[0016]
• In yet another aspect of the present invention, a method of attaching a first layer of tissue to a second layer of tissue includes providing an expandable tissue fastener in a contracted state in a device, the tissue fastener having a proximal member and a distal member, inserting the device into a body passage leading to the first tissue wall, placing the device proximate a location on the first tissue layer, passing the device through the first and second tissue layers, advancing the tissue fastener toward an opening of the device, such that the distal member is completely protruded out of the device and expanded against the second tissue layer, and withdrawing the device and releasing the tissue fastener, such that the proximal member is expanded against the first tissue layer.[0017]
• The present invention is depicted in this disclosure and is particularly suitable in the treatment of GERD, e.g., a fundoplication procedure. However, the tissue fasteners and related deployment methods and systems of the present invention can be used to treat any of a number of different disease conditions, and can be used for fastening any desired body tissues.[0018]
• Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.[0019]
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.[0020]
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.[0021]
• In the drawings:[0022]
• FIG. 1 is a cross-sectional view of the gastrointestinal tract in the region of the lower esophageal sphincter (LES) and the fundus of the stomach;[0023]
• FIG. 2 is a perspective view of a tissue fastener, prior to deployment into a body, according to an embodiment of the present invention;[0024]
• FIG. 2A is a perspective view of a proximal fastening member of the tissue fastener of FIG. 2, showing the proximal fastening member in a deployed state according to an embodiment of the present invention;[0025]
• FIG. 2B is a perspective view of a distal fastening member of the tissue fastener of FIG. 2 in a deployed state, according to an embodiment of the present invention;[0026]
• FIGS.[0027]3-7C are perspective views of various tissue fasteners according to various embodiments of the present invention;
• FIGS.[0028]7D-7F are cross-sectional views of tissue fastener members according to various embodiments of the present invention;
• FIGS.[0029]8A-8R are perspective views of various designs of tissue fastening members according to additional embodiments of the present invention;
• FIGS.[0030]9A-9J are perspective views of various connector post designs according to still other embodiments of the present invention;
• FIGS.[0031]10A-10SS are perspective views of fasteners according to various embodiments of the present invention;
• FIGS.[0032]11A-C are perspective views of an endoluminal deployment system, illustrating various operational stages of the system for deployment of a tissue fastener, according to an embodiment of the present invention;
• FIG. 12A is a schematic illustration of the tissue fastener deployment for a tissue connection procedure, showing the deployment system of FIGS.[0033]11A-C containing the tissue fastener of FIG. 2 and being inserted into the lower esophagus, according to an embodiment of the present invention;
• FIG. 12B is a schematic illustration of the tissue fastener deployment, showing the deployment system penetrating the esophageal wall, according to an embodiment of the present invention;[0034]
• FIG. 13 is a schematic illustration of the tissue fastener deployment, showing the deployment system penetrating the esophageal wall and the fundus wall, according to an embodiment of the present invention;[0035]
• FIG. 14 is a schematic illustration of the tissue fastener deployment, showing the expanded distal fastener member of the tissue fastener holding the fundus wall, according to an embodiment of the present invention;[0036]
• FIG. 15 is a perspective view of a proximal fastening member of the tissue fastener of FIG. 2, viewing from inside the esophagus, after the deployment is complete, according to an embodiment of the present invention;[0037]
• FIG. 16 is a cross-sectional view of the esophageal wall and the fundus wall, with a tissue fastener in place, after the tissue connection procedure;[0038]
• FIG. 17A is a perspective view of a deployment system, with a straight distal tip, according to another embodiment of the present invention;[0039]
• FIG. 17B is a perspective view of a deployment system, with a curved distal tip, according to still another embodiment of the present invention; and[0040]
• FIGS. 18A and 18B are views of a deployment system respectively holding and releasing a tissue fastener member.[0041]
DESCRIPTION OF THE EMBODIMENTS
• Reference will now be made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.[0042]
• A newly developed form of fundoplication, referred to as endoscopic fundoplication, is an endoluminal procedure in which the[0043]fundus wall6 is folded back onto theesophagus wall4. The tissue fold formed between theesophagus3 and thefundus5 then is secured. Endoscopic fundoplication is intended to be performed as an endoluminal procedure in which insertion of required medical instruments occurs through theesophagus3. Such a procedure has the benefits of being less invasive, quicker, and less expensive as compared to previous techniques.
• FIG. 2 shows an exemplary embodiment of a[0044]tissue fastener1 for use in a fundoplication procedure. Thetissue fastener1 has adistal fastening member13, aproximal fastening member11, and a connectingmember12 connecting thedistal fastening member13 and theproximal fastening member11 to each other. Thedistal fastening member13, theproximal fastening member11, and the connectingmember12 are formed as an integrated unit or two or more components pieced together. Thedistal fastening member13 includes a plurality of anchor hooks orlegs23, and theproximal fastening member11 includes a plurality of anchor hooks orlegs21. The plurality ofanchor legs21,23 are constructed to expand from a contracted state to an expanded state. When the legs are in the contracted state, as shown in FIG. 2, thetissue fastener1 is low in profile and can be loaded into a narrow lumen of an endoluminal deployment system for deployment. Once the deployment system is positioned into a desired location within a body, the plurality ofanchor legs21,23 are expanded outwardly to fasten multiple tissue layers together between the distal andproximal fastening members13,11, thereby enhancing the tissue connection.
• In this particular embodiment shown in FIG. 2, each of the distal and[0045]proximal fastening members11,13 is provided with a total of sixanchor legs21,23, that are equally spaced apart. However, it should be recognized that thefastening members11,13 can be provided with more or less number oflegs21,23 with different desired spacing therebetween.
• Preferably, the leading edge of the[0046]distal fastening member13 forms a sharp point or edge15 to assist with penetrating through the tissue layers. Thesharp edge15 may be a trocar-like cutting edge to perform the perforation of the layers itself. It should also be recognized that forming such asharp cutting edge15 may not be necessary if an endoluminal deployment system includes acutting edge40 on its distal tip, as shown in FIGS.17A-B to be described herein.
• FIGS. 2A and 2B show the expanded state of the proximal and[0047]distal fastening members11,13, respectively in an installed state. When thedistal fastening member13 is freed from a restraining means of an endoluminal deployment system, theanchor legs23 of thedistal fastening member13 expand outwardly to form an umbrella-shaped fastening member. Sharp edge ortip15 may be removed or made of a dissolvable, biodegradable material. Similarly, when theproximal fastening member11 is freed from a restraining means of an endoluminal deployment system, theanchor legs21 of theproximal fastening member11 expand outwardly to form a fastening member. Each of theanchor legs21 of theproximal fastening member11 may include one ormore bending portions22 at a location along the length of theleg21, such that thedistal portion24 of theleg21 extends outwardly with respect to the bendingportion22. The bendingportion22 is a relatively flexible portion of an otherwise substantiallyrigid leg21. The bendingportion22 may be facilitated by removal of material or change in geometry along theleg21. Theleg21 may further comprise a variable stiffness along theleg21. For example, the bendingportion22 may consist of a lower stiffness material to facilitate the bending.
• FIGS. 3 through 7 are perspective views of various tissue fasteners in expanded states according to other embodiments of the invention. In an embodiment shown in FIG. 3, the[0048]tissue fastener101 is formed of at least twoelongate members150, such as wires or rods, interconnected in the mid-portion by a connectingmember112. The interconnection may be made through any suitable method, such as welding, brazing, molding, a locking mechanism, etc., or members may be manufactured as an integral piece. In a contracted state, eachmember150 is preferably substantially straight to promote easier insertion through the esophagus and deployment. In an expanded state, shown in the figure, eachmember150 bends outwardly, substantially perpendicular to the connectingmember112, to form the distal andproximal fastening members113,111. The ends of theproximal fastening member111 could be rounded or otherwise protected to reduce trauma when in contact with tissue. Similar to the embodiment shown in FIG. 2, the leading edge of eachmember150 may form asharp cutting edge115 to assist with perforating layers of tissues.
• FIG. 3A illustrates a further embodiment of the fastener of FIG. 3 wherein the distal and proximal ends of the[0049]fastener101 turn inwards upon deployment through tissue layers. These inward turns, or hooks114, would contact tissue and prevent migration offastener101.
• According to another embodiment shown in FIG. 4A, the[0050]tissue fastener201 is comprised of asingle wire250 or rod. Similar to thetissue fastener101 of FIG. 3, thewire250 preferably forms a substantially straight wire in a contracted state. In an expanded state, shown in the figure, thewire250 forms spiral-shaped distal andproximal fastening members213,211 at both ends of the that are substantially perpendicular to the connectingmember212. Thewire250amay also form a spring-shapedfastening member211a,213aat both ends of thewire250a, as shown in FIG. 4B. In that case, the spring-shapedfastening members211a,213amay be substantially parallel to the connectingmember212a. The leading edge of thewire250 may form asharp cutting edge215 to assist with perforating layers of tissues. As a modification and alternative tofastener201, a wire fastener may be delivered in a straight configuration and forms into a coil that may be screwed into the tissue layers. As described below, a suitable material for such fasteners is nitinol.
• The[0051]tissue fastener301 shown in FIG. 5A is comprised of multiple wires integrally attached to a connectingmember312. In a contracted state, eachwire350 preferably forms a substantially straight wire and, in an expanded state, shown in the figure, thewires350 expand outwardly to form spider-shaped distal andproximal fastening members313,311. While the leading edges of thewires350 may form sharp cutting edges to assist with perforating the tissue layers, it may be most beneficial to use an endoluminal deployment system with a trocar-like cutting edge, such as the device shown in FIGS.17A-B, or other perforating instrument to form an opening through the tissue layers prior to the deployment of thetissue fastener301. In an alternative embodiment to FIG. 5A, and as shown in FIG. 5B, thefastening members311,313 may include inwardlybent hooks352 at each end portion of thewires350 to prevent migration of the fastener once deployed onto the tissue layers.
• As shown in FIG. 6, the[0052]tissue fastener401 has a similar configuration as thetissue fastener1 shown in FIG. 2, except that the distal andproximal fastening member413,411 have the same configuration, much like thefastening member11 shown in FIG. 2. In particular, thedistal fastening member413 does not include a sharp pointed edge. For thistissue fastener401, an endoluminal deployment system with a trocar-like cutting edge (e.g., a device shown in FIGS.17A-B) can be utilized.
• FIG. 7A shows a[0053]tissue fastener501, also similar to thetissue fastener1 shown in FIG. 2 in certain respects. Thetissue fastener501 has adistal fastening member513, aproximal fastening member511, and an adjustable connectingmember512. Thedistal fastening member513 and theproximal fastening member511 function in a similar manner as these corresponding structures of thetissue fastener1 shown in FIG. 2. In the embodiment shown in FIG. 7A, thetissue fastener501 includes an adjustable connectingmember512. Oncefastener501 has been placed through the tissue layers to be connected,tail520 offastener501 is pulled taut as illustrated in FIG. 7B andfastening member511 is advanced forward. This action creates a compressive force on the tissues between thefastening members511 and513. Alternatively, the connectingmember512 has an elastic compressive spring force which exerts pulling force between the distal andproximal fastening members513,511 so that the fastening of the multiple tissue layers is enhanced.
• The elastic compressive force may be further combined with the adjustable system as described. FIGS. 7C through 7F illustrate adjustable fasteners of the present invention. FIG. 7C illustrates a[0054]fastener520 havefastening members513 and511 and an adjustable connectingmember521.Member521 further includes bumps (or notches)514 which allowfastening member511 to ratchet forward as eithermember511 is advanced or connectingmember521 is pulled taut to connect tissue layers. FIGS. 7D through 7F illustrate cross-sectional views of two ratcheting systems as described. In FIG. 7D, the ratcheting action is created by virtue offlexible tabs515 located inside fasteningmember511. FIGS. 7E and 7F illustrate friction based or infinite ratcheting systems wherein the interference fit of asingle tab515 of FIG. 7E or ofmultiple tabs515 of FIG. 7F serve to keep connectingmember521 from slipping once fasteningmember511 is advanced forward onto tissue or connectingmember521 is pulled taut. If connectingmember521 is at least partially elastic, the fastener may be self adjusting once in place or the force within the fastener upon the tissues may be controlled.
• FIGS. 8A through 8O show various other exemplary fastening members according to various embodiments of the present invention. As shown in the figures, the fastening member can be formed of a[0055]flat plate601 of virtually any geometric shape, a semisphericaldomed button602, aflexible plate603, amalecot604, aratchet606, anon-orthogonal button607, interconnectablemultiple pieces608, a foldable T-shapedbar609, a twisted or tied coil, string, or other flexibleelongate member610, a stent-like configuration611 wherein the connecting member has a crimped, braided configuration, acotterpin612, arivot613, a V-shapedclip614,615 with or without a flattened top (FIGS. 8N and 8P), a staple-like configuration (FIG. 8O), and stent-like connectors with dogbone or flared ends (FIGS.8Q and8R). Each fastening member connects to or comprises a connectingmember650.
• These various fastening member embodiments will now be described in more detail. In an embodiment shown in FIG. 8D, the[0056]malecot604 includes a plurality of legs orrods604athat assume a cage-like shape when in its normal, expanded position. In another embodiment shown in FIG. 8F, thefastening member606 includes at least one skirt-like or frustoconical-shapedratchet606 which permits movement only in one direction. In yet another embodiment shown in FIG. 8G, a non-orthogonal connection between the connectingmember650 and thefastening member607, which may include any of the described fastening members, is provided. In still another embodiment shown in FIG. 8H, thefastening member608 is formed of multiple pieces that are attached through any suitable means, such as piercing members or barbs. In still another embodiment shown in FIG. 81, thefastening member609 is pivotally coupled to the connectingmember650 to form a T-shaped configuration. Any conventional connecting devices and methods may be used to couple thefastening member609 and the connectingmember650. In still another embodiment shown in FIG. 8J, thefastening member610 is formed of a twisted or tied element. Preferably, themember610 is made of a single piece and double-looped. In still another embodiment shown in FIG. 8K, thefastening member611 is formed of a stent-like braided configuration. The middle portion of the configuration is crimped by a plurality of rings or is wrapped with a coil and constitutes the connecting member. In an expanded state, rings are removed or a coil is partially unwrapped at the distal end portion, or the distal end is not otherwise crimped like the connecting member portion, to form afastening member611 shown in the figure. FIGS. 8Q and 8R illustratestent type fasteners660,670 respectively having a dogbone or flare shape at each end. These fasteners are deployed in a constricted manner and expanded or allowed to expand into a fastener comprised of a singular structure. The fasteners of FIGS. 8K, 8Q, and8R may be constructed in any manner similar to fabricating stents as is known in the art, including but not limited to knitting, weaving, twisting, laser-cut tubes, welded wires and molding.
• In still another embodiment shown in FIG. 8L, the[0057]fastening member612 is formed of a bar or a plate, fixedly attached the connecting member by a cotterpin612aor a stopper. In still another embodiment shown in FIG. 8M, thefastening member613 is formed by attaching a rivot to the connectingmember651. In this case, the connectingmember651 includes anengagement member653 protruding outwardly at its distal end, which engages the rivot to form thefastening member613. In still another embodiment shown in FIG. 8N, thefastening member614 is a clip having two ormore legs614b. The clip is expandable in a transverse direction, as indicated by arrows in the figure, thereby enhancing the tissue connection. Preferably, one or more bands or O-rings614aare attached to limit the expansion to a desired extent and to abut the tissue layers. It should also be recognized that a plate or otherflat surface614cmay be attached to, or otherwise be integral with, the expanded clip at its distal end, as shown in FIG. 8P.
• In still another embodiment shown in FIG. 8O, the[0058]fastening member616 forms a staple-like configuration. Similar to the embodiments shown in FIGS.3-5, thewire616apreferably forms a substantially straight wire in a contracted state and, in an expanded state, shown in the figure, thewire616aexpands outwardly or inwardly to form the staple-like configuration. Alternatively, an anvil can be placed behind tissue layers to bend thewires616aand form the staple-like configuration. It should be recognized that more than two wires can be provided. Any other suitable designs providing the similar function may be utilized. In addition, the fastener may include any combination of fastening members and connecting posts.
• In an embodiment, as shown in FIG. 8E, a[0059]tissue fastener605 also may include a hollow bore630 passing through the tissue fastener to inject a therapeutic chemical agent or an adhesion promoting substance. The tissue fastener is provided with aninjection port670 to permit introduction of the therapeutic substances or the adhesion promoting substance. The hollow bore630 may be provided with a one-way valve (e.g., check valve)672 to prevent a backflow.Fastener605 may also comprise a weephole660 or other means alongpost662 to allow delivery of the chemical agent or adhesion promoting means between the tissue layers.
• FIGS.[0060]10A through10OO show various other exemplary fastening members according to various embodiments of the present invention. These various embodiments, in addition to certain others described throughout this specification, adjust to varying tissue thickness so that sufficient tension, and in many embodiments substantially constant tension, is placed on the tissue to hold the tissue layers together. In many of the disclosed embodiments, such adjustment is performed by adjusting the length of the connecting member between the fastening members and/or by providing a means, in many cases associated with a fastener member, for providing a substantially constant tension on the tissue layers. Most of the embodiments shown in FIGS.10A-10OO include a pair of opposed fastener members connected by a connecting member. It is to be understood that fastener members and connecting members of any embodiment may be used in combination with fastener members and connecting members of other embodiments, as desired.
• FIG. 10A shows a “T”-shaped[0061]tissue fastener720 having afirst fastening member721, a connectingmember722, and asecond fastening member723.Member721 may comprise any suitable biocompatible elongate member, such as a portion of hypodermic tubing. Connectingmember722 may comprise suture material, wire, or any other like biocompatible material that fixedly connects tomember721, preferably in a fashion that permitsmember721 to articulate with respect to connectingmember722 for ease of delivery and to the extent needed while implanted.Member723 may comprise any bead or ball-shaped structure that permits connection to connectingmember722.Member723 may include a slot therein permittingmember722 to slide through so that the length ofmember722 betweenmembers721,723 may be adjusted depending on the thickness of the connected tissue layers. For example,member723 may be similar to a fishing weight having a slit therein to holdmember722. As an alternative and as shown in FIG. 10A′,member723 may be atorsion spring723′ having a pair of arms. When the arms are forced open in the direction of the arrows, connectingmember722 loosens from withinspring723′ andspring723′ can slide relative tomember722 and be cinched against the tissue layers or anadditional member721. When the arms are released,spring723′ securesmember722 in position.
• FIGS.[0062]10B and10B′ show atissue fastener730 havingfirst fastening member721, connectingmember722, and asecond fastening member731 having a means for providing a substantially constant force on the tissue layers. In this case, the means includes a flexible bellows-like structure. The bellows ofmember731 permit adjustment in the length of connectingmember722 betweenmembers721 and731. FIG. 10B shows the bellows ofmember731 in an expanded, relaxed state. The bellows are contracted during delivery through the esophagus and to the tissue layers. Then, as shown in FIG. 10B′, whenfastener730 is applied to tissue layers735, the bellows will expand to place a sufficient force against the tissue layers to hold together those layers. In addition, through the use of the bellow-like structure, a substantially constant force is applied to the tissue layers, reducing tissue irritation or loosening of the tissue fastener.
• FIGS. 10C, 10D, and[0063]10I show variations on means to maintain constant force on the tissue layers. In FIG. 10C,tissue fastener740 includes asecond fastener member741 having aspring742 between two plate-like structures743, such as disks or buttons. In FIG. 10D,tissue fastener743 includes asecond fastener member751 having aballoon752 between the twostructures743. In FIG. 10I,tissue fastener800 includes asecond fastener member801 having aspring802. One end ofspring802 connects to structure743 and the other end ofspring802 is free and places a substantially constant force against the tissue layers. Any suitable, biocompatible, compressible structure may take the place ofspring742,balloon752, orspring802.
• FIG. 10E shows a “double-T” shaped[0064]tissue fastener760 that is essentially of one-piece construction.Fastener760 has two opposingfastener members762, each taking the form of eithermember721,member743, or others described throughout this specification.Members762 are connected by an elastic connectingmember761 that permits an adjustable length ofmember761 betweenmembers762.Member761 may be made of a elastic, biocompatible material, similar to a rubber-band.
• FIG. 10H shows a similar arrangement as FIG. 10E.[0065]Fastener790 includes opposingfastener members762 interconnected by a bungee cord-like member792.Member792 may be pulled tightly (elongated) betweenmembers762 during delivery to the tissue layers and then released so thatmember792 shortens and grows in diameter. The growth in diameter may permit an interference fit betweenmember792 and a hole, notch, slit, or other opening within one or both of themembers762, so thatmember792 secures tomembers762.
• In addition to certain embodiments already described, other embodiments include structure associated with one or both fastener members to permit adjustment of the length of the connecting member between the fastener members. For example, FIG. 10F shows a[0066]fastener770 having first andsecond fastener members771,772 and a connectingmember773.Member773 includes a plurality of beads, balls, or similarenlarged structures774 spaced along the length ofmember773. As an alternative, the connecting member may include a plurality of notches spaced along the length of the member. The structures may be evenly or unevenly spaced as desired. Thestructures774 may be used in combination with afrangible member772 having a hole that permitsstructures774 to travel through the hole to shorten the length ofmember773 betweenmembers771,772. To place more a desired force on the tissue layers,additional structures774 may be pulled through the hole inmember772.Member772 may be constructed to include a notch therein to accommodate astructure774. The through hole inmember772 may be constructed to permit passage ofstructures774 in only one direction, i.e. away frommember771 to shorten the length ofmember773 betweenmembers771,772. In addition,member771 may have a similar construction asmember772 to permit passage ofstructures774 therethrough.Excess connecting member773 may be removed by any suitable method.
• FIG. 10G shows a[0067]fastener780 having afastener member781 with a ratchet-like mechanism to permit passage of connectingmember782 therethrough in one direction (shown by arrow). Thus,member781 can move in the direction opposite the arrow to tightenfastener780 on the tissue layers, with the ratchet-like mechanism preventing loosening ofmember782 relative tomember781. Similarly, FIG. 10J shows afastener810 having afastener member811 withteeth812 to capture connectingmember813 and prevent loosening.Teeth812 may be angled in the direction of the applied force to more strongly graspmember813.
• FIG. 10K shows a[0068]fastener820 having afastener member821 with abiased locking mechanism822. Thelock822 includes aball bearing823 or like structure contained within a through hole or passage ofmember821, and aspring824 biasing bearing823 into the passage. Bearing823 will lock connectingmember825 within the passage whenmember825 is not being adjusted in length between the fastener members.
• Alternative locking mechanisms are shown in FIGS. 10M and 10N. FIG. 10M shows a[0069]locking mechanism840 that includes a pair ofeccentric wheels841 that rotate to lock connectingmember842 in position aftermember842 is adjusted in length between fastener members, similar to eccentric wheel locking mechanisms used on sailboats.Mechanism840 may be located within one or both fastener members of a fastener. FIG. 10N shows a similar arrangement, having alocking mechanism850 with eccentric wedges used to lock connectingmember852 in position.
• FIG. 10L shows a[0070]fastener830 having afirst fastening member831, a connectingmember832, and a second connectingmember833.Member833 has a two-piece construction that includes adisk834 that snaps or otherwise fixedly attaches to a complementary dish-shaped head835. After connectingmember832 is pulled through a passage in head835 to adjust the length ofmember832 betweenfastener member831 and head835,disk834 is forced into and attached to head835, securingmember832 in position.
• FIGS. 10O and 10P show front views of[0071]exemplary fastener members860 and870 respectively.Member860 includes a wedge-shapedopening861 therein that accepts a connecting member.Member871 has a wedge-shapednotch871 in its side also for accommodating a connecting member. After being pulled taut within tissue and between fastener members, a connecting member may be pulled in the direction of the point of thewedge opening861 or notch871 to lock the connecting member in place.
• FIG. 10Q shows a[0072]fastener880 having afastener member881 having slots around its perimeter that accept connectingmember882.Member881 may be twisted, as shown by the arrow, so thatmember882 wraps aroundmember881 to adjust the length ofmember881 betweenfastener members881,883. When the desired length is achieved,member882 can lock in a notch or like structure onmember881.
• FIGS. 10T and 10U show[0073]fasteners910 and920 respectively.Fastener910 includes two dome-shapedfastening members911 that fully invert in the deployed position (bottom of FIG. 10T) to exert additional force against the tissue layers. Similarly,fastener920 includes two dome-shapedfastening members921 that invert in their centers when in the deployed position (bottom of FIG. 10T) to exert additional force against the tissue layers.
• FIG. 10V shows a[0074]fastener member930 shaped in a figure eight and having two openings. A connectingmember931 may be adjusted in length between fastening members by windingmember931 around and through the openings, similar to a rappel loop. A small notch inmember930 may holdmember931 oncemember930 has been drawn to the desired tension.
• FIG. 10W shows a[0075]fastener940 that includes aloop941 and aconnection member942.Loop941 may comprise a cable, wire, or other suitable biocompatible material.Loop941 extends through the tissue layers twice and joins at its ends atconnection member942, which may be located on either side of the tissue layers, through any suitable means.Loop941 may be tightened and excess loop portions may be excised by cutting or any other suitable method. This embodiment results in a relatively small footprint at the tissue layers.
• FIG. 10X shows a[0076]fastener member951 that is a spring clip. Once connectingmember952 is adjusted to the desired tension,spring clip951 may be inserted over aneedle953 through which connectingmember952 extends (see top portion of FIG. 10X).Spring clip951 is extended past the distal end ofneedle953 to grasp connectingmember952 adjacent tissue layers954 (see bottom portion of FIG. 10X).
• The right-hand side of FIG. 10Y shows a deployed[0077]fastener960 that includes acollet961 and a C-spring962. The left-hand side of FIG. 10Y showscollett961 and C-spring962 in undeployed positions, i.e. in an open mode. Much like open drill bit chuck,collett961 can fit over anysize connecting member963. Oncecollet961 is in position over connectingmember963 and C-spring962, or an O-ring or other like structure, is slipped overcollet961,collet961 closes onmember963. This embodiment permits fastener adjustments.
• FIG. 10Z shows a[0078]fastener member971 in both an open position (left-hand side) and a closed position (right-hand side).Member971 includes acap973 with teeth to grip aconnector member972.Cap973 is held to the remainder ofmember971 by a hinge, such as a living hinge. Pullingmember972 openscap973 enough to let theconnector member972 adjust.Cap973 snaps back down tosecure member972. The exit of connectingmember972 fromcap973 could be at a slot or notch at an edge ofcap973.
• As shown in the variations of FIGS.[0079]10DD and10EE (showing end views ofalternative fasteners971 withcaps973′ and973″ respectively), the exit of connectingmember972 fromcap973′,973″ could be at a throughhole974 off-center from the fastener hole975 (FIG. 10DD) or aslot976 incap973 offset from fastener hole975 (FIG. 10EE). In these alternative embodiments, pullingmember972 to adjust its length will open thecap973′,973″ slightly.
• FIG. 10AA shows a[0080]fastener980 in the undeployed (left-hand side) and deployed (right-hand side) states.Fastener980 includesfastener members981 connected by a connectingmember982.Members981 have an inward wedge shape that will displace some force to friction along an axis of the connectingmember982. The wedge increases surface area contact of thefastener member981 with the tissue layers and therefore friction between the layers and themember981. The wedge portion may include a fabric surface to increase friction. The area of the fabric may be made larger than the surface area of the wedge so that the fabric may bunch up to further increase surface area and friction. A fabric surface or covering may be placed over any suitable fastener member described herein.
• FIG. 10BB shows a[0081]fastener990 having afastener member991 and a connectingmember992 attached at its ends tofastening members993.Member991 may be a pledget or any other suitable member described herein or known in the art.Members993 may be similar tomember921 described above in connection with FIG. 10A. In FIG. 10BB,member992 extends through the a tissue layers andmember991 in two places. After deployment offastener990, the portion ofmember992 extending throughmember991 may be twisted (as shown by the arrow) to place desired tension against the tissue layers. Connectingmember992 may be similar tomember722 of FIG. 10A and may be a polymer suture so that ultrasonic or other energy may be used to fuse the twisted portion together by melting.
• As a variation of the embodiment of FIG. 10BB, FIG. 10CC shows a[0082]fastener990′ having a suture-like member992 that extends throughmember991 and is formed into a z-like pattern994 on a surface ofmember991 away from the tissue.Member992 tightens betweenmembers991 and993 asmember992 is pulled in the direction of the arrows. As a further variation of the embodiment shown in FIG. 10BB, FIG. 10S shows afastener900 similar tofastener990 except thatfastener900 has a one-piecesecond fastener member902.
• FIGS.[0083]10FF,10GG, and10HH show variations of “T”-shaped fastener embodiments.Fastener1000 includesfastener members1002 each in the shape of an “H” connected by connectingmember1001.Fastener1010 includes “T” shapedfastener members1011 connected by a connecting member that splits into threeportions1012a,1012b, and1012c.Fastener1020 is much likefastener1010 and includes “T” shapedfastener members1021 connected by a connecting member that splits into fourportions1022a,1022b,1022c, and1022d. As with all of the embodiments described herein, any combination of fasteners and connecting members from FIGS.10FF-10HH may be used to form a suitable fastener.
• FIG. 10II shows various embodiments of[0084]fasteners1030,1040,1050 that include wire frames as fastener members. The wire frames may be configured in any suitable shape, including triangular, round, and irregular, as shown. It is preferable that the wire frame be collapsible into a flattened shape for ease of delivery and then expand upon deployment.
• FIG. 10JJ shows embodiments of[0085]fasteners1055,1056 havingfastener members1057,1058 in kite-like configurations. Thefastener members1057,1058 may include a combination of wire material on the external perimeter portions and suture material as thespokes1059 extending form the connecting members to the wire perimeter. The fastener members may be configured in any suitable shape, including square, diamond, etc., and, as in the FIG. 10II embodiments, collapse into a flattened shape for delivery and expand upon deployment.
• FIG. 10KK shows a[0086]fastener1060 made of a combination ofsuture material1061 connecting a pair ofhypotubes1062. the suture material connects to a connectingmember1063 at an approximate midpoint of thefastener1060. The suture material in the embodiments of FIGS.10JJ and10KK, and any other embodiments disclosed herein, may be elastic, fuzzy (like dental floss), and/or swell upon deployment.
• FIGS.[0087]10LL-10OO show various embodiments of fasteners designed to have an increased footprint on the tissue layers. When each of these embodiments is used in a fundoplication procedure, a button is placed on the esophageal side of the tissue layers and a mating cup is placed on the stomach side. These arrangements spread force on the tissue layers beyond the button and prevent pull-through in the esophagus. For example, FIG. LL shows a button shapedfastener member1072 adjacentesophageal tissue1074 and a matingcup fastener member1071adjacent stomach tissue1075. A connectingmember1073 extends betweenbutton1072 andcup1071. FIGS.10MM-10OO show other shaped buttons and mating cups. FIG. 10MM showsfastener1080 with aconvex cup1082 connected by a connectingmember1083 to aconcave mating cup1081. FIG. 10NN showsfastener1090 with a wedge-shapedcup1092 connected by a connectingmember1093 to acorresponding mating cup1081. FIG. 10OO showsfastener1100 with aconvex cup1102 connected by a connectingmember1103 to aconcave mating cup1101 surrounded by a flattenedarea1104 that further increases the footprint on the tissue layers. Convex, wedge, and other like-shaped buttons increase tissue contact area relative to a flat button arrangement. Other shaped buttons and mating cups may be used.
• FIG. 10PP shows a[0088]fastener1110 in a delivered state (top) and a deployed state (bottom).Fastener1100 is a tube or rod that includes a plurality of slits at ends1111. Upon deployment at the desired site, the slits at the ends permit the ends to attain a fastener member arrangement having a plurality ofarms1112. Such deployment may be attained through a shape memory material, a deployment mechanism that separates the slits to formarms1112, or any other suitable method. FIG. 10QQ shows a variation of the fastener embodiment shown in FIG. 10PP.Fastener1120 includes a pointed, slottedend1121 that, when deployed, shapes intoarms1122. The pointed end may permit puncturing through the tissue layers. The pointed tip may remain, may be removed through any mechanical, thermal or other suitable method, or may be made of a absorbable material.
• FIG. 10RR shows a[0089]fastener1130 that includes a connectingmember1132 withexpandable fastener members1131 at each end. The top portion of FIG. 10RR shows the delivered state in whichmembers1131 remain in a collapsed configuration, and the bottom view showsmembers1131 in a deployed configuration.Members1131 may be balloons and may be expanded by fluid actuation or any other suitable method. Likefastener1120,fastener1130 may be modified to include a pointed tip.
• FIG. 10SS shows[0090]fasteners1140 and1150 havingfastener members1141,1151 respectively that include non-straight connector pathways. Such pathways create an interference between the connectingmember1142,1152 and themember1141,1151 to aid in securing them together. In the embodiments shown,member1141 includes a wavy, or serpentine, pathway formember1142, andmember1151 includes a pathway with a bend. Other non-straight pathways may be used.
• FIG. 10R shows a[0091]fastener890 having a plurality of connectingmembers891 across the tissue layers to spread the force applied to the tissue surfaces. The connectingmembers891 may be unconnected at their ends, or may be connected at their ends to be a single member wrapped around thefastener members892,893.
• In further embodiments, friction between the connector member and the fastener members may be increased by a rough surface on the connector member (by for example braiding, knots, fibers), an elastic connecting member, a coated connecting member, or a fabric covered connecting member. In addition, the through hole of the fastener member(s) may include gripping teeth arranged at an angle to prevent reverse movement of the connecting member. Embodiments as appropriate throughout this specification also may include a quick-setting, water tolerant adhesive or glue, such as cyanoacrylate, may be used to pack the passage or hole within a fastening member.[0092]
• FIGS. 9A through 9J show various other exemplary connecting members according to other embodiments of the present invention. As shown in the figures, a connecting member can be formed of a[0093]telescopic bar701, a collapsible bellows702, a cylindrical bar with a ball-socket arrangement703, a stent-like braided configuration704, a spiral-shapedspring705, awebbed spiral spring706, acrimped structure707, ratchet708,elastic member710, orwebbed member712. In particular, at least the connectingmembers701,702,705,706,710, and712 shown in FIGS. 9A, 9B,9E,9F,9I, and9J are configured to be expandable/contractible so as to provide compressive forces to enhance fastening. In an embodiment shown in FIG. 9E, the connectingmember705 is formed of a spiral-shaped spring. As shown in FIG. 9F, the spiral-shaped spring may be covered with a conformingmaterial706a, such as, for example, polyurethane, silicone, polytetrafluoroethylene, webbed material or other suitable material. In another embodiment shown in FIG. 9G, the connectingmember707 is configured to be coupled to afastening member618. Preferably, apledget717 or a ring is utilized to couple between the connectingmember707 and thefastening member618 to allow moveability of thefastening member618 along the connectingmember707. In yet another embodiment shown in FIG. 9H, the connectingmember708 includes at least one skirt-like or frustoconical-shapedratchet708awhich permits movement only in one direction.
• FIG. 9I illustrates a post embodiment wherein the post comprises an elastic material. The embodiment of FIG. 9J illustrates a[0094]post712 comprising a webbed material, for example, a knit or woven material. Any other suitable designs providing the similar function may be utilized.
• A connecting member[0095]701-712 is preferably strong enough to maintain its integrity and utility even under stressful events, such as running, swimming, sneezing, coughing, vomiting, or the like. These connecting members701-712 can provide compressive forces to enhance the fastening of the tissues. In addition, these connecting members701-712 provide enhanced flexibility for traversing through a tortuous path within a body.
• Many of the disclosed tissue fasteners, especially those that expand from a contracted, delivered state to an expanded, deployed state, may be made of a shape memory material, such as, for example, nickel titanium alloy (e.g., Nitinol) or a polymer. By utilizing a shape memory material, the fastening member is able to transform from its delivered state to its deployed, functional state automatically upon deployment. Alternatively, the reconfiguration can be obtained by utilizing a material that is reactive to a predetermined condition, e.g., temperature, pH, electrical current, and/or a number of other internal and external stimuli or by its material properties such as elasticity. The expandability of the distal and proximal fastening members can also be obtained by utilizing any suitable mechanical means, such as, for example, a manually actuated expander.[0096]
• The disclosed tissue fasteners are preferably composed of a biocompatible and biocompliant material, i.e. similar to the compliance of the tissue being connected. The fasteners also may be coated with thrombogenic agents and therapeutics to prevent tissue inflammation. Examples of materials for a tissue fastener, including its coating or covering, include silicone-based polymers, nylon-based polymers, hydrid Teflon-textile based polymers, polypropylene, polyethlylene, or growth factors. Polymer coating materials further include polycarboxylic acids, cellulosic polymers (e.g., cellulose acetate and cellulose nitrate), gelatin, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, polyanhydrides (e.g., maleic anhydride polymers), polyamides, polyvinyl alcohols, copolymers of vinyl monomers (e.g., EVA), polyvinyl ethers, polyvinyl aromatics, polyethylene oxides, glycosaminoglycans, polysaccharides, polyesters (polyethylene terephthalate), polyacrylamides, polyethers, polyether sulfone, polycarbonate, polyalkylenes, halogenated polyalkylenes (e.g., polytetrafluoroethylene), polyurethanes, polyorthoesters, proteins, glycoproteins, recombinant proteins, polypeptides, silicones, siloxane polymers, polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate and blends and copolymers thereof, coatings from polymer dispersions such as polyurethane dispersions (e.g., BAYHDROL®), fibrin, collagen and its derivatives, polysaccharides (e.g., celluloses, starches, dextrans, alginates and derivatives), hyaluronic acid, and squalene emulsions. Other preferred materials include polyacrylic acid (e.g., HYDROPLUS®), described in U.S. Pat. No. 5,091,205, the disclosure of which is hereby incorporated by reference, and a copolymer of polylactic acid and polycaprolactone. In a preferred embodiment, the fastener comprises a bioabsorbable material. A preferred coating would be one which would minimize tissue inflammation around the fastener.[0097]
• The disclosed tissue fastener can be made of biodegradable, bioresorbable, and/or bioabsorbable material. The clamping force created by the fastener will induce adhesion formation between the tissue layers. This can occur in a controlled fashion by carefully selecting a material with a predetermined degradation rate. The bioabsorbable material may be formed of cross-linked polymer networks that can be manufactured to be responsive to body temperature, light, pH, and/or a number of other external/internal stimuli.[0098]
• Deployment of a tissue fastener is discussed below with reference to an exemplary endoluminal deployment system, shown in FIGS.[0099]11A-C. For illustration purpose, thetissue fastener1 shown in FIG. 2 is used to illustrate various deployment stages of a tissue fastener, according to an embodiment of the present invention. The deployment system, however, may be used with various other embodiments of tissue fasteners described above. Thedeployment system50 includes aflexible overtube52 configured to accommodate atissue fastener1 in a delivered state, and acoupling mechanism53 for grasping and moving thetissue fastener1 along the lumen of theovertube52. Thedeployment system50 may also be configured to accommodate multiple tissue fasteners that are stacked axially. The coupling mechanism may be amechanical grasper53 that is remotely operable by suitable actuation means at the proximal end (not shown) of theovertube52. Thesystem50 also includes apusher54 for guiding the tissue fastener along theovertube52. Thepusher54 may include a hollow lumen through which a cable for operating thegrasper53 passes. Theovertube52 includes alumen56 preferably having a diameter capable of accommodating thetissue fastener1. In at least one embodiment, theovertube52 may be incorporated into a conventionally known endoluminal fundoplication device, described in U.S. Pat. No. 6,086,600, the disclosure of which is hereby incorporated by reference. A device as taught in that patent may be used to fold the esophageal and fundus walls together, withovertube52 then used to apply one or more fasteners. Theovertube52 is preferably made of polymer, polymer reinforced with metal, or metal hypotube. The overtube is preferably low in profile and flexible enough to traverse the cricopharyngeal area transorally.
• FIGS. 18A and 18B show an exemplary embodiment of[0100]deployment system50, wherein agrasper53 is fixedly connected to a distal end of apusher54.Grasper53 includes a pair ofarms53′ each terminating inbent hooks53″.Arms53′ are elastic and biased in the open position shown in FIG. 18B. During delivery of a tissue fastener,arms53′ are contracted withinovertube52, ands hooks53″ mate with ahead11′ offastener member11 to hold the fastener to be deployed. When the fastener is deployed andpusher54 is moved distally so thatgrasper arms53′ move past the end ofovertube52,arms53′ bias to the open position andrelease member11. Other suitable coupling methods and devices known in the art for mechanically or otherwise coupling a tissue fastener to a delivery mechanism may be used, such as for example, graspers, pull wires, hooks, elastic couplings, springs, cups, and hypotubes.
• In another method of detaching a tissue fastener, such as a fastener made of a single wire or any other suitable fastener described in this disclosure, the fastener may be attached to an external mechanism, such as a wire, that runs outside the body. The external wire then may carry the electrical current to electrically detach the fastener when installation of the tissue fastener is complete. Technology known as a Gugliemi Detachable Coil (GDC) or GDC coil detachment, such as that described in U.S. Pat. No. 5,423,829, incorporated by reference herein, may be used in connection with this embodiment.[0101]
• Referring back to the embodiment shown in FIG. 11B, the[0102]tissue fastener1 is contained within the flexible overtube52 and endoluminally delivered to a desired site in a body to protect the body lumen from possible damage caused by thesharp edge15 of thetissue fastener1. As shown in FIG. 11B, once the distal end opening55 of theovertube52 is placed at the desired site, thetissue fastener1 is advanced toward the tissue surface, such that thesharp edge15 of thetissue fastener1 makes contact with the tissues to be perforated. It should be understood that the tissue fastener may be configured to perforate through the tissue layers, or may be configured to pass through an opening already made by other perforating instruments or theovertube52. For example, the overtube may include a sheath covering it to puncture through tissue. Once thetissue fastener1 passes through tissue layers, thedistal fastener member13 is further advanced out of theovertube52, and theanchor legs23 are expanded outwardly to form an umbrella-shapedfastening member13, as shown in FIG. 11C, to hold the tissue layers together.
• FIGS. 12A through 16 show implantation of a[0103]tissue fastener1 in a fundoplication procedure, using the endoluminal deployment system shown in FIGS.11A-11C. The deployment includes performing the delivery and placement of thetissue fastener1 in essentially one step. As shown in FIG. 12A, thedeployment system50 containing thetissue fastener1 is transorally inserted into thelower esophagus3 and positioned adjacent to a desired location near the distal end of theesophagus3 for the fundoplication procedure.
• Preferably, prior to the insertion of the endoluminal deployment system into the[0104]esophagus3, thefundus wall6 is lifted and folded toward theesophageal wall4 as shown in FIG. 12A. Any suitable mechanism for lifting thefundus wall6 toward theesophageal wall4 may be used for this purpose. An example of such a suitable device is shown and described in U.S. Pat. No. 6,086,600, the entire disclosure of which is incorporated by reference herein. It should also be understood that the lifting device may be formed in combination with theendoluminal deployment system50.
• After the distal end opening[0105]55 of theovertube52 positioned proximate a desired perforation site of theesophageal wall4, thetissue fastener1 is advanced toward the esophageal wall surface, such that thesharp edge15 of the tissue fastener makes contact with the surface, as illustrated in FIG.12B Tissue fastener1 preferably extends out of theovertube52 only enough so that theedge15 extends from theopening55, yet a portion oflegs23 remain in theovertube52 so that thedistal fastening member13 remains in a contracted state. As discussed above, thetissue fastener1 may be configured to cut through theesophageal wall4 and thefundus wall6, or may be configured to penetrate through an opening already made by other instrument or theovertube52. As shown in FIG. 13, theovertube52 with thesharp edge15 of thetissue fastener1 protruded out of theovertube52 is advanced through theesophageal wall4 and thefundus wall6.
• Once the[0106]tissue fastener1 passes through the layers of esophageal andfundus walls4,6, thedistal fastening member13 of thetissue fastener1 is further advanced out of theovertube52 causing theanchor legs23 of thedistal fastening member13 to expand outwardly to form an umbrella-shapedfastening member13, as shown in FIG. 14. After thedistal fastening member13 is securely placed against theinside fundus wall6, theovertube52 is withdrawn and releases thetissue fastener1 to completely expose theproximal fastening member11 of thetissue fastener1. Theanchor legs21 of theproximal fastening member11 expand outwardly to form thefastening member11. FIG. 15 is a perspective view of theproximal fastening member11 of thetissue fastener1, viewing from inside the esophagus, after the deployment is complete. Thedistal fastening member13, i.e., the gastric side, should be robust and resistant to low stomach pH, and theproximal fastening member11, i.e., esophageal side, should be low in profile to prevent possible lumen occlusion.
• FIG. 16 is a cross-section view of the[0107]esophageal wall4 and thefundus wall6, with a tissue fastener in place, after the fundoplication procedure is complete. The expanded distal andproximal fastener members13,11 of thetissue fastener1 hold and maintain the esophageal andfundus walls4,6 together in place to create the fundoplication. Thetissue fastener1 should be strong enough to hold the esophagus and fundus together with a force of approximately 6 lbs without damage to theesophageal wall4 orfundus wall6. Furthermore, thetissue fastener1 should be sufficiently strong enough to maintain its integrity and utility even under stressful events, such as running, swimming, sneezing, coughing, vomiting, or the like. Depending on the type of tissue fasteners used and the desired fastening strength, more than one tissue fastener may be installed. In that instance, a deployment system capable of loading multiple tissue fasteners can be used.
• The invention is not limited to the exemplary embodiment used to illustrate the deployment of the[0108]tissue fastener1. Other various tissue fasteners encompassed in this disclosure can be used with the deployment systems and methods described above. Moreover, the disclosed tissue fasteners of the present invention can be used with any other deployment mechanisms conventionally known in the art. In particular, for thetissue fasteners301,401 that do not encompass sharp cutting edges, an opening through theesophageal wall4 and thefundus wall6 can be made by other piercing instruments, or theendoluminal deployment system70 having a cuttingedge40 on its distal tip, as shown in FIGS. 17A and 17B.
• FIGS. 17A and 17B illustrate[0109]endoluminal deployment systems70 used for the disclosed tissue fasteners, according to still other embodiments of the present invention. Similar to thedeployment system50 shown in FIGS.10A-C, thedeployment system70 shown in FIGS. 17A and 17B includes aflexible overtube71 having either a straight or curved distal portion and configured to accommodate atissue fastener70 in a contracted state.Fastener70 is represented withfastening head74 andconnector72, but this illustration is not intended to limit the possible embodiments. In this embodiment, overtube71 is represented as a needle.Overtube71 may be of any size necessary to deployfastener71 while working within the confines of anatomical space and instrument space needed to fold and retain the fundus against the esophageal wall. Theovertube71 includes anopening45 at its distal tip, through which a tissue fastener passes. Theopening45 is defined by a slanted edge to form asharp cutting edge40. During deployment, thesharp cutting edge40 forms an opening through the tissue layers prior to the deployment of a tissue fastener. Thefastener70 is deployed by releasing a fastening head on one side of the tissue layers undergoing attachment and withdrawingovertube71 from the tissues to release a second fastening head on the opposite tissue layer side.
• Other devices and methods for delivery and deployment of tissue fasteners disclosed herein may be used. Suitable, exemplary methods and devices are disclosed in U.S. application Ser. No. ______ of Robert Devries et al., filed on the same day as this disclosure, and entitled “Devices and Methods for Fastening Tissue Layers.” The complete disclosure of that application is incorporated by reference herein.[0110]
• In addition, although the present invention is depicted in this disclosure as being used in the treatment of GERD, e.g., a fundoplication procedure, it is to be understood that the tissue fastener and related deployment methods and systems of the present invention can be used to treat any of a number of different disease conditions, and can be used for fastening any desired body tissues.[0111]
• Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.[0112]

Claims (73)

What is claimed is:

1. A tissue fastener used to join multiple tissue layers, comprising:

a proximal member configured to expand from a delivered state to a deployed state;

a distal member configured to expand from a delivered state to a deployed state; and

a connecting member connecting the proximal member to the distal member;

wherein, in the deployed state, the proximal member and the distal member secure the multiple tissue layers together.

2. A tissue fastener according toclaim 1, wherein at least one of the proximal member, the distal member, and the connecting member is formed of a shape memory material.

3. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member is expanded by mechanical means.

4. A tissue fastener according toclaim 1, wherein the tissue fastener is comprised of a biocompatible material.

5. A tissue fastener according toclaim 1, wherein the tissue fastener is comprised of a biocompliant material.

6. A tissue fastener according toclaim 1, wherein at least one of the proximal member, the distal member, and the connecting member includes a thrombogenic agent.

7. A tissue fastener according toclaim 1, wherein at least one of the proximal member, the distal member, and the connecting member includes a coating having a therapeutic agent.

8. A tissue fastener according toclaim 7, wherein the therapeutic agent promotes adhesion between the tissues undergoing attachment.

9. A tissue fastener according toclaim 1, wherein at least one of the proximal member, the distal member, and the connecting member is formed of bioabsorbable material.

10. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member includes a plurality of legs configured to extend outwardly in the deployed state.

11. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member includes a plurality of legs each having at least one bending portion proximal to a portion of the leg and wherein the portion of the leg is configured to extend outwardly in the deployed state.

12. A tissue fastener according toclaim 1, wherein the distal member includes a sharp edge.

13. A tissue fastener according toclaim 1, wherein the distal member comprises a sharp point.

14. A tissue fastener according toclaim 1, wherein the proximal member, the distal member, and the connecting member are formed of at least two wires interconnected in a middle portion thereof to form the connecting member.

15. A tissue fastener according toclaim 14, wherein each of the wires is essentially straight in the delivered state and bent in the deployed state.

16. A tissue fastener according toclaim 1, wherein the proximal member, the distal member, and the connecting member are formed of a single wire.

17. A tissue fastener according toclaim 16, wherein the wire is essentially straight in the delivered state and spiral-shaped in the deployed state.

18. A tissue fastener according toclaim 16, wherein the wire is essentially straight in the delivered state and includes non-straight portions in the deployed state.

19. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member includes a flat surface formed of a shape memory material.

20. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member includes a plurality of flexible members that form a cage-like structure in the deployed state.

21. A tissue fastener according toclaim 1, wherein at least one of the proximal member and the distal member includes a T-shaped member.

22. A tissue fastener according toclaim 1, wherein at least one of the proximal member, the distal member, and the connecting member includes a stent-like structure.

23. A tissue fastener according toclaim 1, wherein the connecting member is configured to exert compressive force between the distal member and the proximal member.

24. A tissue fastener according toclaim 1, wherein the connecting member is telescopic.

25. A tissue fastener according toclaim 1, wherein the connecting member includes a collapsible bellow.

26. A tissue fastener according toclaim 1, wherein the connecting member includes a ball-socket arrangement.

27. A tissue fastener according toclaim 1, wherein the connecting member includes a braided configuration.

28. A tissue fastener according toclaim 1, further comprising a hollow bore passing through at least a portion of the tissue fastener.

29. A tissue fastener according toclaim 28, wherein the bore is configured to administer an adhesion promoting agent between tissue layers.

30. A tissue fastener according toclaim 1, wherein the tissue fastener has a length sufficient to attach a wall of an esophagus to a wall of a gastric fundus.

31. A delivery system configured for deployment of an expandable tissue fastener, comprising:

a flexible tube having a lumen configured to accommodate a tissue fastener in a contracted state;

a pusher for guiding the tissue fastener along the lumen of the tube; and

a coupling system coupled to a distal end of the pusher and configured to grasp the tissue fastener.

32. A delivery system according toclaim 31, further comprising a device for folding two walls of tissue together.

33. A delivery system according toclaim 32, wherein the tube is positioned in a lumen of the device.

34. A delivery system according toclaim 31, wherein the tube has a length sufficient enough to extend out of a body.

35. A delivery system according toclaim 31, wherein the tube includes a sharp cutting edge formed at its distal end.

36. A delivery system according toclaim 31, wherein the tube is configured to accommodate multiple tissue fasteners.

37. A delivery system according toclaim 31, further comprising actuation means for the coupling system at a proximal end of the tube.

38. A delivery system according toclaim 31, wherein the tube has a sheath covering it to puncture through tissue.

39. A delivery system according toclaim 38, wherein the sheath includes a puncturing tip.

40. A delivery system according toclaim 31, wherein a puncturing tool is delivered through the tube.

41. A method of attaching a first wall of tissue to a second wall of tissue, comprising:

providing an expandable tissue fastener in a contracted state in a device, the tissue fastener having a proximal member and a distal member;

inserting the device into a body passage leading to the first tissue wall;

placing the device proximate a location on the first tissue wall;

passing the device through the first and second tissue walls;

advancing the tissue fastener toward an opening of the device, such that the distal member is completely protruded out of the device and expanded against the second tissue wall; and

releasing the tissue fastener, such that the proximal member is expanded against the first tissue wall.

42. A method according toclaim 41, wherein the distal member includes a sharp edge, and further comprising advancing at least a portion of the distal member out of the device, prior to passing the device through the first and second tissue walls.

43. A method according toclaim 42, further comprising penetrating the first and second tissue walls with the sharp edge.

44. A method according toclaim 41, comprising perforating the first and second tissue walls with a perforating instrument, prior to passing the device through the first and second tissue walls.

45. A method according toclaim 41, wherein the passing step includes perforating the first and second tissue walls by a sharp distal end of the device.

46. A method according toclaim 41, wherein the first tissue wall is a esophageal wall and the second tissue wall is a gastric fundus wall.

47. A method according toclaim 46, further comprising folding the fundus wall proximate to the esophageal wall.

48. A method according toclaim 41, wherein the tissue fastener punctures the fundus wall prior to puncturing the esophageal wall.

49. A method according toclaim 41, wherein the tissue fastener punctures the fundus wall and the esophageal wall at substantially the same time.

50. A tissue fastener used to join multiple tissue layers, comprising:

a first member;

a second member;

a connecting member connecting the first member to the second member; and

means for applying a substantially constant force on the tissue layers.

51. The tissue fastener ofclaim 50, wherein the applying means is compressible.

52. The tissue fastener ofclaim 51, wherein the applying means includes a bellows-like structure.

53. The tissue fastener ofclaim 51, wherein the applying means includes a spring.

54. The tissue fastener ofclaim 51, wherein the applying means includes a balloon.

55. The tissue fastener ofclaim 50, wherein the connecting member includes the applying means, and the applying means is an elongate, elastic member.

56. A tissue fastener used to join multiple tissue layers, comprising:

a first member;

a second member;

a connecting member connecting the first member to the second member; and

means for adjusting a length of the connecting member between the first and second members.

57. The tissue fastener ofclaim 56, wherein the adjusting means includes structure associated with the first member for releasably securing the connecting member to the first member.

58. The tissue fastener ofclaim 57, wherein the structure is configured to restrict passage of the connecting member in a direction through the first member.

59. The tissue fastener ofclaim 58, wherein the structure includes a ratchet-like mechanism.

60. The tissue fastener ofclaim 58, wherein the structure includes a biased locking mechanism.

61. The tissue fastener ofclaim 60, wherein the biased locking mechanism includes a spring biasing a bearing.

62. The tissue fastener ofclaim 58, wherein the structure includes eccentric cams.

63. The tissue fastener ofclaim 56, wherein the adjusting means includes teeth associated with the first member.

64. The tissue fastener ofclaim 56, wherein the first member includes the adjusting means, and the adjusting means includes structure for inverting the first member.

65. The tissue fastener ofclaim 56, wherein rotation of the first member relative to the connecting member adjusts the length of the connecting member between the first and second members.

66. The tissue fastener ofclaim 65, wherein the adjusting means includes slots on the first member to accommodate the connecting member.

67. The tissue fastener ofclaim 56, wherein the first member includes the adjusting means, and the adjusting means includes a dish that accommodates a corresponding disk to secure the connecting member therebetween.

68. The tissue fastener ofclaim 56, wherein the adjusting means includes a notch within the first member to receive the connecting member.

68. The tissue fastener ofclaim 57, wherein the structure associated with the first member cooperates with connecting member structure to adjust the length of the connecting member.

69. The tissue fastener ofclaim 68, wherein the connecting member structure includes a plurality of enlargements spaced along the connecting member.

70. The tissue fastener ofclaim 69, wherein the plurality of enlargements permit incremental adjustments in the length of the connecting member between the first member and the second member.

71. The tissue fastener ofclaim 57, wherein the structure associated with the first member includes a torsion spring with arms.

72. A tissue fastener used to join multiple tissue layers, comprising:

a first member;

a second member;

a connecting member connecting the first member to the second member;

wherein the connecting member includes a first portion substantially parallel to a second portion, the first and second portions extending between the first and second members and through the first member to connect and form a knot-like configuration against the first member.

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