Patent Publication Number: US-2018042599-A1

Title: Apparatus and method for suturing a tissue

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/091,613, filed Apr. 6, 2016, which is a continuation of PCT Patent Application No. PCT/IL2015/050599, filed on Jun. 14, 2015, which claims the benefit of priority to U.S. Provisional Patent Application No. 62/012,363, filed on Jun. 15, 2014, all of which are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to a device for suturing tissue and, more particularly, to an apparatus and device capable of threading a continuous or single adjusted length and depth of suture through a tissue and to a method of using same to approximate, ligate, suture or fixate tissue and/or an implant such as a mesh. 
     Suturing remains a common approach for repair of tissues and is used for tissue approximation, ligation and fixation of tissue access sites, organs, vessels, fixation of meshes and other implants or devices and the like. Although largely dependent on the skill of the surgeon, the results obtained using a suture are highly predictable and reliable. 
     Alternatives to suturing developed over the years such as staples, fasteners (tackers), anchors and tissue adhesives, have gained varying degrees of acceptance and are used for tissue repair in both open and minimally invasive procedures. Nonetheless, suturing remains ubiquitous in surgical repair due to availability of a wide variety of suturing kits at relatively low costs and the mechanical advantages afforded by suturing. 
     Thus, suture remains a mainstay of surgical repair however, it is not without disadvantages. Placing a number of stitches can be tiring and time-consuming which can lead to suturing errors that can compromise the integrity of repair. In addition, manipulation of a suture needle as well as access to the suturing location can be difficult especially in minimally invasive surgery due to the nature of the minimally invasive surgery and/or the limited anatomical space around the target tissues, while tying knots with a desired amount of tension requires precise manipulation of the suture ends further complicating and slowing open, and in particular, minimally-invasive surgeries. In fact, for many procedures the time spent suturing may be significantly greater than the time spent treating the underlying target tissues. 
     Although tissue stapling devices and adhesives as well as devices which employ a combination of anchors and sutures can traverse these limitations of suturing by enabling rapid ligation of tissue, the tissue ligation/fixation created thereby is oftentimes less reliable or does not involve easy access and large number of sutures. 
     Thus, there remains a need for a device capable of ligating/fixating tissues rapidly and reliably while being operable within a confined anatomical space through a minimally invasive approach. 
     SUMMARY OF THE INVENTION 
     Some embodiments of the invention may be related to an apparatus for suturing a tissue. The apparatus may include an outer tube, a thread threaded in the outer tube and at least one anchoring element located inside the outer tube and configured to be inserted into the tissue from an outlet end of the outer tube. The outer tube may be configured to freely accommodate the thread and the at least one anchoring element, and the anchoring element may include a central elongated body adapted to be threaded on the thread and having at least one recess, the recess having a wide end and a narrow end, the narrow end is for gripping the thread during suturing of the tissue. 
     Some additional embodiments of the invention may be related to an insertion device for inserting a thread and one or more anchoring elements into a tissue. The insertion device may include: an outer tube, a thread guide tube for guiding a thread inserted in the thread guide tube. The outer tube may be configured to freely accommodate the thread guide tube and one or more anchoring elements threaded on the thread guide tube such that each anchoring element can slid along the outer tube to be exit from an outlet end of the outer tube. 
     Some embodiments of the present invention may include an anchoring element for anchoring a suture in a tissue including a central elongated body adapted to be threaded on a thread and having at least one recess, the recess having a wide end and a narrow end, the narrow end is to grip the thread during anchoring. 
     Some embodiments of the invention may be related to a method of suturing a tissue. The method may include piercing the tissue while inserting to the tissue an apparatus for suturing, the apparatus may include an outer tube, a thread inserted in the outer tube and at least one anchoring element located inside the outer tube, threaded on the thread and configured to be inserted into the tissue from an outlet end of the outer tube, wherein the anchoring element comprises a central elongated body adapted to be threaded on the thread and having at least one recess, the recess having a wide end and a narrow end, the narrow end to gripping the thread during suturing of the tissue. The method may further include advancing the at least one anchoring element towards the outlet end of the outer tube to cause the at least one anchoring element to exit from the outlet end of the outer tube into the tissue such that the at least one anchoring element is anchored in the tissue and threaded on the thread and causing the thread to be gripped at the narrow end of the recess of the anchoring element. 
     Some embodiments of the present invention may include a device including: (a) an elongated shaft; (b) a plurality of anchor elements and a suture co-axially disposed along the elongated shaft; and (c) a handle attached to a proximal end of the shaft, the handle being for actuating release of an anchor element attached to a portion of the suture from a distal end of the shaft. 
     According to further embodiments of the invention described below, the anchor element may be hollow with the portion of the suture threaded there-through. 
     In some embodiments, the plurality of anchor elements may be concentric with the suture. 
     In some embodiments, the plurality of anchor elements and the suture may be disposed within a lumen of the elongated shaft. 
     In some embodiments, the device may further include at least one of: mechanism for advancing the anchor element and the suture in a direction of the distal end. 
     In some embodiments, the anchor element may attach and/or lock to the portion of the suture when the anchor element is released from the distal end. 
     In some embodiments, a wall of the anchor element may include at least one longitudinal slot for trapping the portion of the suture when the anchor element is advanced in the direction of the distal end. 
     In some embodiments, the portion of the suture may loop through the anchor element. 
     In some embodiments, the device may be capable of positioning a plurality of contiguous loops of the suture each may have a dedicated anchor element threaded thereon through a tissue wall. 
     In some embodiments, a length of the portion of the suture released from the distal end may be adjustable. 
     In some embodiments, the distal end of the shaft may be configured for piercing through a tissue. 
     In some embodiments, the anchor element may be configured for piercing through a tissue. 
     In some embodiments, the device may further include a first tube disposed within the lumen, wherein the plurality of anchor elements may be disposed around the first tube and the suture may be disposed within the first tube. 
     According to still further embodiments, the device may further include a second tube disposed within the lumen and around the plurality of anchors. 
     According to still further embodiments, the second tube may include a tissue piercing distal end. 
     According to still further embodiments, the device further may include a mechanism for advancing the second tube and the anchor element in a direction of the distal end of the shaft. 
     In some embodiments, the device may further include a suture cutting element in or on the shaft. 
     In some embodiments, the mechanism for advancing the second tube and the anchor element may be actuatable from the handle. 
     In some embodiments, the mechanism for advancing the second tube and the anchor element may be capable of retracting the second tube. 
     In some embodiments, the suture cutting element may be actuatable from the handle. 
     Embodiments of the invention may be directed to a tissue suturing device that may include: (a) an elongated hollow shaft surrounding a first co-axial tube and a second coaxial tube having a tissue piercing end; (b) a suture disposed within the first tube; (c) a plurality of anchoring elements disposed around the first tube and within the second tube; and (d) a handle attached to a proximal end of the shaft, the handle may be for actuating a mechanism for advancing and retracting the second tube and an anchor element in a direction of a distal end of the hollow shaft so as may enable the anchor element to grab the suture and form a loop of the suture attached to the anchor element when released the distal end of the shaft. 
     Some embodiments of the present invention may be related to a method of suturing tissue. Embodiments of the method may include: (a) providing a tissue suturing device having an elongated shaft and plurality of anchor elements and a suture co-axially disposed along the elongated shaft; (b) positioning a distal end of the elongated shaft through an opening in the tissue; and (c) actuating release of an anchor element attached to a loop of the suture from the distal end of the shaft. 
     In some embodiments, the method may further include (d) retracting the distal end of the elongated shaft from the opening in the tissue to thereby juxtapose the anchor element against an internal surface of the tissue and pull strands of the suture loop out of the opening. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which: 
         FIG. 1  is an illustration of a side view of an exemplary apparatus for suturing a tissue according to some embodiments of the present invention; 
         FIGS. 2A-2C  are isometric illustrations of cutaway views of the distal portion of the exemplary apparatus of  FIG. 1  according to some embodiments of the invention; 
         FIGS. 3A-3B  are isometric illustrations of exemplary anchoring elements with a suture loop according to embodiments of the invention; 
         FIGS. 3C-3I  are isometric illustrations of anchoring elements according to some embodiments of the invention; 
         FIGS. 4A-4J  are illustrations of several steps of the suture-delivery distal end of the apparatus of  FIG. 1 , according to some embodiments of the invention; 
         FIG. 5A  is an illustration of several contiguous suture loops with attached anchoring elements positioned through a tissue according to some embodiments of the invention; 
         FIG. 5B  is an illustration of magnified view of one thread loop and attached anchoring element positioned through the tissue according to some embodiments of the invention; 
         FIG. 5C  is an illustration of a thread loop with attached bio-absorbable anchoring element (shown partially absorbed) positioned in a tissue according to some embodiments of the invention; 
         FIGS. 6A-6B  are illustrations of an embodiment of a mechanism for thread holding and cutting according to some embodiments of the invention; 
         FIGS. 7A-7D  are illustrations of a handle of the apparatus of  FIG. 1 , showing the anchoring element pusher mechanism and tissue piercing tube (Fig. 7 A- 7 B) and the handle mechanism in normal mode ( FIG. 7C ) and actuated mode ( FIG. 7D ) according to some embodiments of the invention; 
         FIGS. 7E-7F  are illustrations of the apparatus of  FIG. 1  with a flexible insertion device ( FIG. 7E ) or deflectable insertion device ( FIG. 7F ) according to some embodiments of the invention; 
         FIG. 8A  depicts photographs of components useable for assembling an apparatus according to some embodiments of the invention; 
         FIGS. 8B-8C  are photographs of a delivery of an anchored suture through a foam board ( FIG. 8B ) and the running stitch created by sequentially delivering several anchoring elements from a prototype assembled from the components shown in  FIG. 8 a   , according to some embodiments of the invention; 
         FIGS. 9A-9B  are photographs of two anchoring sites created using the apparatus for suturing a tissue ( FIG. 9A ) and testing of the load capacity of a single anchoring site ( FIG. 9B ), according to some embodiments of the invention; 
         FIGS. 10A-10H  are illustrations of various steps in the delivery or insertion of an anchoring element into a tissue using the device of  FIGS. 2A-2C , according to some embodiments of the invention; 
         FIGS. 11A-11B  are illustrations of a device for suturing a tissue comprising a plurality of anchoring elements according to some embodiments of the invention; and 
         FIG. 12  is a flowchart of a method of suturing a tissue according to some embodiments of the invention. 
     
    
    
     It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. 
     DETAILED DESCRIPTION OF THE PRESENT INVENTION 
     In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. 
     Some embodiments of the present invention may be related to an apparatus for suturing or fixating a tissue. The tissue may soft or hard tissue. Such apparatus may include three (3) main components, a thread, one or more anchoring elements for anchoring the thread in the tissue and an insertion device for inserting the thread and anchoring elements into the tissue. Such a tissue suturing device which may be used to approximate, suture, ligate, and fixate tissue and an implant such as a mesh. Specifically, the embodiments of the invention may be used for repair of tissue defects, anastomosis of vessels or organs, suturing of access sites, anchoring or fixating soft or hard tissue, fixating meshes or other implants or devices to a tissue, closing natural or artificial tissue openings, modifying anatomical spaces, lifting, stretching, pulling or retracting tissues or organs using open or minimally invasive approaches. 
     The principles and operation of the embodiments of the invention may be better understood with reference to the drawings and accompanying descriptions. 
     Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
     Devices for ligating and fixating tissues which may be used via minimally invasive approaches are well known in the art, such devices typically utilize sutures, mechanical fasteners/anchors or a combination thereof 
     A suturing system or suturing device according to embodiments of the invention may be capable of positioning and anchoring one or more separated or contiguous loops of suture with or without adjustable suture lengths and with or without adjustable suture depth through a tissue while traversing the need for a tissue suturing head that spans the tissue wall or for a curved needle capable of threading in and out of a tissue wall. 
     In some embodiments, a tissue suturing device may be capable of approximating, ligating and fixating tissues and/or implants such as meshes and the like and may be used in both open and minimally invasive surgeries. 
     Embodiments of such device may include: a rigid or flexible elongated device body (also referred to herein as “shaft” or “an insertion device”) which may be with or without a distal curved section towards its outlet and a plurality of anchoring elements and a suture co-axially disposed along the shaft. As is further described herein, the anchoring elements and suture may be disposed on the shaft (e.g. in a guide rail running along the length of the shaft) or within the shaft (e.g. in a lumen running along the length of shaft). The suture may also be arranged on the shaft outlet dividing the outlet area In any case, the anchoring elements and sutures are arranged co-axially (i.e. the suture and anchoring elements may be arranged along the length of the shaft) and preferably concentrically. The anchoring elements may be arranged such that they assume the same rotational position along the shaft, or alternatively, the anchoring elements may be arranged with rotational offset therebetween. 
     As used herein, the term “suture” refers to any non-rigid elongated element that can be looped through a tissue. A suture may be made from a thread that may be fabricated from a natural or synthetic polymer, an alloy or any other bio compatible material, and may include a single filament or several braided or twisted filaments. The thread may be of any diameter, shape (e.g. with edges), length and pull strength. The thread may be permanent or degradable or mixed (partly degradable and partly permanent) depending on the tissue sutures and the site of suturing. Examples of threads suitable for use with embodiments of the present invention may include absorbable threads that may result in absorbable sutures fabricated from, for example, catgut, polyglycolic acid, polylactic acid, polydioxanone, or caprolactone. Non-absorbable threads to form permanent sutures that may be used with embodiments of the present invention may be fabricated from, for example, silk, nylon, polypropylene, or polyester. 
     As used herein the phrase “ anchoring elements” (or simply anchor) refers to any element having a length which is preferably greater than a diameter thereof with a diameter suitable for delivery through a hole in a tissue (self-generated or pre-generated) and a length suitable for abutting the hole and anchoring thereagainst. As is further described hereinunder, the anchoring elements may be configured such that it can slide on a thread or a suture and attach thereto. 
     Although anchoring may be provided by contact between the anchor and inner tissue wall, additional anchoring features may be used to increase such anchoring. For example, the anchoring element body can include a roughened surface, deployable tabs or barbs or fin or any other element or elements that may enhance tissue fixation via adhesion, tissue penetration or tissue pinching. 
     Embodiments of a device of the present invention may further include a handle which may be attached to the proximal end of the shaft (the outer tube). The handle may be permanently attached to the shaft or inner tubes or removably attached thereto. The latter case may enable the use of several handle types with one shaft and/or reuse of the handle or use of one handle with several shafts. 
     The handle may actuate release of one or more anchoring elements attached to a portion of a thread from the distal end of the shaft. As is further described hereinunder, actuation of the anchoring elements -thread release mechanism (via the handle), may deliver an anchoring element attached to a loop of thread (e.g., for forming a suture) through an opening in tissue wall. The anchoring element may abut the internal surface of the tissue and may anchor the loop of thread through the tissue opening. 
     Embodiments of an exemplary device according to the invention may carry a single continuous strand of thread disposed co-axially (e.g., concentrically) with a plurality of suture elements along the length of the shaft. Such exemplary device may be used to deliver several contiguous loops of the thread (while enabling adjustment of suture length, depth and tension) without having to access both sides of the tissue. In other words, embodiments of the present device may position a running stitch through a tissue wall by approaching a tissue surface and without having to access both sides of the tissue wall and/or without necessitating threading of a needle in and out of tissue. This embodiment of the present device may particularly be advantageous in cases where a surgical mesh is used in hernia defect repair and/or where the hernia defect is sutured. A hernia mesh is typically fixated to an abdominal wall via trans-facial suturing by looping a suture in and out of the abdominal wall. Such suturing is time consuming, associated with postoperative pain and infections and requires a high level of skill since the stability of the mesh depends on the quality of suturing. Post the trans-facial fixation, the mesh is adhered to the tissue usually with a tacking device. The tacks protrude into the abdominal cavity and may cause tissue adhesions. In addition, numerous tacks are needed to secure the mesh which increases the likelihood of damaging nerve tissue and inducing postoperative pain. Tacks may not hold the tension and may detach from the tissue specially if opposing the tissue in a non-vertical angle. 
     Referring now to the drawings,  FIGS. 1-7F  are illustrations of exemplary apparatus for anchoring a suture in a tissue. Embodiments of apparatus  10  may be configured to deliver of one or more anchoring element-thread loops through a tissue wall and can be used in minimally invasive procedures (endoscopic, laparoscopic) as well as open procedures. 
     Embodiments of apparatus  10  may include: an insertion device  12  (e.g., a shaft) having a proximal end  14  (releasable or permanently) attached to a handle  16 . Device  12  may be configured to insert a thread and one or more anchoring elements into a tissue. Apparatus  10  may further include a thread  26  and at least one anchoring element  24 , both illustrated in  FIG. 2 . Handle  16  may house a mechanism for managing the suture and for actuating tissue piercing, anchoring element-thread delivery holding and severing of the thread at distal end  18  of insertion device  12 . User interface  20  of handle  16  may include controls (buttons, triggers dials) for setting the depth of tissue penetration, actuating tissue piercing, generating tension on the thread, delivering the anchoring element and attached loop of thread through the tissue and for holding and severing the thread at the end of a suturing cycle (of one or more anchoring elements). Handle  16  is described in greater detail hereinbelow with reference to  FIGS. 7A-7D . 
     Reference is made to  FIGS. 2A-2C  that are illustrations of distal end  18  of apparatus  10  in greater detail. Insertion device  12  of apparatus  10  may include: an outer tube  22 , a thread guide tube  46 , a thread  26  threaded in thread guide tube  46  and at least one anchoring element  24  located inside outer tube  22 . In some embodiments, thread  26  may be located outside of insertion device  12  (not threaded in the insertion device), such that only a small portion of the thread is guided, lead or held by distal end  18 . In the exemplary embodiment shown in  FIG. 2 , insertion device  12  may composed of five concentrically (and optionally coaxially) arranged tubes with outer tube  22  housing four (or less) internal tubes. Outer tube  22  can be fabricated from an alloy or polymer (rigid or flexible) for example, stainless steel, cobalt chrome, Nitinol, PEEK (polyether ether ketone), carbon, composite material, reinforced plastics, Ceramics with a length of 5 mm-2000 mm or more. Outer tube  22  may have an outer diameter (OD) of 0.3 mm to 20.1 mm and an internal diameter (ID) of 0.25 mm to 20.05 mm. Outer tube  22  shown in  FIGS. 2A-2C  is cylindrical in shape and as such has a substantially circular cross section. However, outer tube can be provided with any external cross sectional shape including rectangular, square triangular and the like as long as the lumen thereof is shaped to accommodate the tubes carried therein. 
     Outer tube  22  may be configured to freely accommodate guide tube  46  (e.g., thread guide tube) and one or more anchoring elements  24  threaded on guide tube  46  such that each anchoring element  24  can slid along outer tube  22  to be exit from an outlet end  38  (e.g., the distal end) of outer tube  22 . Alternatively, outer tube  22  may guide anchoring elements  24 . In such embodiments, device  12  does not include guide tube  46  and anchoring elements  24  may be threaded directly on thread  26 . In some embodiments, the distal end  38  of outer tube  22  may have a sharpened end adapted for piercing the tissue or blunt in order to penetrate a tissue directly (port less delivery) or it may be blunt and deliverable through a premade tissue access site (port or port-less). 
     In some embodiments, at least a portion of thread  26  may be inserted into thread guide tube  46  to be guided along the longitudinal axis of device  12  and a second portion of the thread may be located external to device  12 . The connection between the first and second portions may thread an anchoring element  24  to form a suture loop. Alternatively, both the first and second portions may be inserted into device  12 , such that only a loop of thread including anchoring element  24  may exit device  12  into the tissue. 
     Device  12  may further include a thread severing (cutting) tube  28  which may be positioned internally to outer tube  22 . Thread severing tube  28  can be fabricated from an alloy or polymer (rigid or flexible) (e.g. stainless steel, cobalt chrome, Nitinol, PEEK, carbon, composite material, reinforced plastics, ceramics) with a length of 5 mm to 2000 mm, an outer diameter (OD) of 0.3 mm to 20.1 mm and an internal diameter (ID) of 0.25 mm to 20.05 mm. 
     Thread severing tube  28  may include finger-like longitudinal projections  30  which are circumferentially spaced apart via cutouts  32 . Projections  30  may be machined or laser cut from the tube using approaches well known in the art. Projections  30  may widen distal to proximal and may be configured as sharpened blades. 
     A thread trapping tube  34  may be positioned inside thread severing tube  28 . Tube  34  can be fabricated from an alloy or polymer (e.g. stainless steel, cobalt chrome, Nitinol, PEEK, carbon, composite material, reinforced plastics, ceramics) with a length of 5 mm to 2000 mm, an outer diameter (OD) of 0.3 mm to 20.1 mm and an internal diameter (ID) of 0.25 mm-20.05 mm. 
     As is shown in  FIGS. 6A-6B  tube  34  may cooperate with projections  30  of thread severing tube  28  to sever thread  26 . To enable such functionality, distal portion of tube  34  may include thread traps  42  for trapping thread  26  pulled therein. Advancement of tube  34  and thread severing tube  28  out of opening  38  (Shown in  FIGS. 4I-4J ) and rotation or translation of tube  34  against suture severing tube  28  (as shown by arrow in  FIG. 6B ) may cut the thread against a sharpened blade-like projection  30 . 
     Insertion device  12  may further include a needle  36 . Needle  36  may be positioned inside tube  34  or inside outer tube  22  or severing tube  28  and houses one or more anchoring elements  24  and thread  26 . The anchoring elements may be separated by guide tube  46 . Needle  36  may be located inside outer tube  22  such that a sharpened end  40  of needle  36  may be in proximity to outlet end  38  of outer tube  22  and one or more anchoring element  24  may be located inside needle  36 . Needle  36  may be advanced distally within tube  22  (via handle  16 ) to penetrate the abdominal wall and/or a tissue and/or mesh and deliver anchoring element  24  and thread  26  therethrough. When handle  16  may be actuated, a plunger  37  (shown in  FIG. 7A ) may move forward (distally) and move anchor element  24  distally with or without ejection of anchoring element  24  out of needle  36 . In an alternative embodiment, plunger  37  may move along with needle  36  and actuation of handle  16  retracts tissue piercing tube  36  to eject anchor  24 . 
     In some embodiments, needle  36  may include at least one elongated slit  39  substantially parallel to the needle&#39;s central axis. The elongated slit (illustrated in  FIGS. 2B and 2C ) may be used to guide a fin element included in anchoring element  24 . The slit  39  may be ended towards the shaft outlet  38  or at the shaft outlet. The fin element may protrude over the slit. The fin element is discussed in detailed below with respect to  FIG. 31 . 
     Needle  36  may be fabricated from an alloy or polymer (e.g. stainless steel, cobalt chrome, Nitinol, PEEK, carbon, composite material, reinforced plastics, ceramics) with a length of 5 mm to 2000 mm an outer diameter (OD) of 0.25 mm to 20.05 mm and an internal diameter (ID) of 0.2 mm to 20 mm. Needle end  40  can be double beveled or pointed. Needle end  40  proximal part may be blunt for not cutting the thread. Plunger  37  can be fabricated from similar materials and lengths with an OD slightly smaller than an ID of tissue piercing tube  36 . 
     The lumen of a distal end portion  40  of needle  36  may be configured to ensure that anchoring element  24  may tilted (with respect to the longitudinal axis of needle  36 ) when pushed out of needle  36  (via plunger  27  or by another embodiment via advancing assemble  45 ). Needle end  40  angle may enable the ejection of anchor element  24  tilted by forming an angle with respect to needle&#39;s  36  longitudinal axis. For example, the lumen of tube  36  can include a bump or ‘ramp’ or shaped with an angle to initiate tilt of anchor  24  as it exits the distal end of tube  36 . 
     It will be appreciated that the tissue piercing function of needle  36  may also be provided by anchoring element  24  and/or outer tube  22 . In some embodiments, anchoring element  24  may include a sharpened end for piercing the tissue at at least one of the anchoring element. As anchoring element  24  may be advanced within tube  22 , a sharpened end thereof can be carried through the tissue by tube  22  and provide the through tissue path for tube  22  (and anchoring element  24  and thread  26  carried thereby). 
     Guide tube  46  may be fabricated from an alloy or polymer (e.g. stainless steel, cobalt chrome, Nitinol, PEEK, carbon, composite material, reinforced plastics, ceramics) and optionally coated (e.g. Teflon©) to enable smooth feeding of thread  26  into tube  46  therein and threading anchoring element  24  thereupon. Guide tube  46  may have a length of 5 mm to 2000 mm, an outer diameter (OD) of 0.1 mm to 20 mm and an internal diameter (ID) of 0 to 20 mm. 
     Guide tube  46  may serve to facilitate sliding of anchoring elements  24  thereupon and thread  26  therein. An anchoring element  24  threads directly over thread  26  once it is advanced off of tube  46 . 
     Although guide tube  46  may be shown with a circular cross section, it will be appreciated that a guide tube  46  with a non-circular cross section (e.g. oval, square) can also be used herein. Use of such a guide tube  46  in device  12  included in apparatrus  10  may be advantageous since it may be used to guide anchoring elements  24  (of similar cross sectional shape) in a predefined rotational direction thus ensuring that all anchors  24  exit tube  36  in the same rotational direction. 
     In some embodiments, insertion device  12  included in apparatus  10  may further include an advancing assembly  45 , illustrated in  FIGS. 2B-2C , for advancing one or more anchoring elements  24  along outer tube  22  towards the outlet end  38  of outer tube  22 . In some embodiments, advancing_assembly  45  may further be configured to cause anchoring element  24  exiting outer tube  22  from outlet end  38  to tilt in the tissue relative to the direction of longitudinal axis of outer tube  22 . Advancing mechanism  45  may include a tilting mechanism  47  located in proximity to outlet end  38 . Tilting mechanism  47  may include an elongated flexible pusher  49  to push anchoring element  26 . Pusher  49  may be inserted via slit  39  of needle  36 , thus bending while advancing element  26 , causing element  26  to tilt. The tilting may start already while anchor is entering the proximal part of the needle sharp end  40  and continue after exiting the needle. For example, pusher  49  may be inserted into an edge or a fin element included in anchoring element  24 . Advancing mechanism  45  may cause advancing of each anchoring element separately. Alternatively, advancing mechanism  45  may cause advancing of a plurality of anchoring elements simultaneously. Detailed disclosure of the tilting mechanism is given with respect to  FIGS. 10E-10G . Advancing mechanism  45  may be operated and activated activating a trigger or by pushing a button in user interface  20  included in handle  16 . Advancing mechanism distal end may have various shapes. In some embodiments, advancing mechanism  45  may push an anchor element  24  distally into the tissue more distant from the needle end, generating an axial distant from the anchor proximal end and the needle distal end causing the anchor to channel its own rout in the tissue. 
     In some embodiments, part or all of the tilting may occur while anchor element  24  progresses distally in the tissue while radial forces are applied causing the anchor element  24  to progress distally in a curved rout after the thread  26  is locked on the anchor  24  (pendulum effect) and/or when the advancing mechanism  45  pushes the anchor in the tissue in a curved rout and/or when suture arm or arms  52  may be pulled distally. 
     In some embodiment, locking of anchor element  24  in the tissue may be enhanced by the anchor rout or traveling. The needle  36  may penetrate the tissue wall axially. Anchor element  24  may be actuated by the handle  16  progress distally while in the needle  36 . Once exiting needle  36  with or without tilted position, anchor  24  may progress in a curved out. Thus, tubes  22 ,  28 ,  34 , needle  36 , mechanism  45  and tube  46  provide the following functionality to insertion device  12  and the device may be manufactured with or without each of the following components: 
     (i) Outer tube  22  may support internal tubes  28 ,  34 , needle  36  and  46 ; a distal end  38  thereof may be positionable against a tissue wall to enable device actuation in position and holding the thread against the mesh or tissue surface; outer tube  22  may be fixed in position. 
     (ii) Needle  36  may pierce through a tissue wall when advanced distally from handle  16  to enter the abdominal cavity or to deliver anchoring element  24  and thread  26  through the tissue. Advancing mechanism  45  may advance anchoring element  24  along needle  36  and/or outer tube  22 . Sharpened end  40  of needle  36  is extendable out of opening  38  a predetermined distance as set by handle  16 . 
     (iii) Tube  34  may hold thread  26  to enable a new anchoring element  24  delivering cycle over the suture. Thread severing tube  28  and tube  34  may cooperate to sever thread  26  and enable thread severing and holding prior to delivery of one or more anchoring elements  24 ; both tubes may advance out of tube  22 ; tube  34  with captured thread end may be aligned with, and rotated (or optionally translated) within tube  28  to sever suture. 
     (iv) Guide tube  46  serves to facilitate smooth advancement of both anchoring element  24  and thread  26 . 
     As is mentioned herein, apparatus  10  and insertion device  12  may be used to deliver one or more anchoring element-thread loops through a tissue. Some exemplary embodiments of anchoring elements  24  with and without attached loop of thread  26  are shown in  FIGS. 3A-3G . 
     An anchoring element according to embodiments of the invention may be anchored in the tissue and may further include a thread locking element which may lock thread  26  during or after insertion of the anchoring element to the tissue. A plurality of such anchoring elements may be consecutively inserted into the tissue to anchor and generate a running suture. Embodiments of anchoring element  24  may include a central elongated body  23  adapted to be threaded on a thread  26  and a locking element such as for example, at least one recess  50 . Additional locking element different from recess  50  is discussed with respect to  FIG. 3D . The locking element may be configured to lock thread  26  on anchoring element  24  during insertion of the anchor element. In some embodiments, recess  50  may have a wide end  51  and a narrow end  53 . Narrow end  53  may grip thread  26  during anchoring. In some embodiments, anchoring element  24  may include a central elongated body  23  adapted to be threaded on a thread  26  and having a locking element, such as at least one of recess  50 , slit, or the like. 
     Central elongated body  23  may substantially a hollow cylinder or tube and includes at least one, preferably 2 or 4 or more recesses  50  for trapping two ‘arms’  52  of a suture loop  54  therein. Recesses  50  may include a tapered or sawtooth configuration or preferably, a slightly tapering rectangular shape having a wide end  51  and a narrow end  53  as is shown in  FIG. 3C . Anchoring element  24  end portions may terminate in a blunt or sharpened end (for penetrating through tissue as described above). Anchoring element  24  may be fabricated from a biocompatible alloy or polymer such as PEEK or Absorbable Polymer (PGA, PLA PLGA) or the like. Anchoring element  24  may be biodegradable or not depending on use. 
     Alternative configurations of anchoring element  24  may utilize any thread-trapping elements which are ‘activated’ prior to release of anchoring element into tissue. Such configurations may include, for example, an element fabricated from a shape memory alloy (such as Nitinol) or any other elastic material (e.g. elastic polymer) that may be linearized when anchoring element  24  may positioned (threaded) on guide tube  46  and folds to form a shape that traps and engages thread  26  once released from guide tube  46 . For example,  FIG. 3D  illustrates an anchoring element  24  which may include an exemplary locking element in the form of one or more deformable tabs  25  which deform inward to trap thread  26  once anchoring element  24  may be released from device  12 . Tabs  25  may be maintained linear with anchoring element  24  body when anchoring element  24  may be positioned on tube  46  within insertion device  12 . When released, anchoring element  24  may slide off tube  46  and tabs  25  bend inward to the position shown in  FIG. 3D . 
     In any case, anchoring element  24  may be configured such that it is capable of sliding on thread  26  within outer tube  22  and locking thereagainst when delivered out of the distal end of apparatus  10 . 
     As anchoring element  24  may slide off tube  46  (when anchor  24  advanced distally along suture  26  via handle  16 ), anchoring element  24  may thread directly over thread  26 . Release of anchoring element  24  (threaded or not threaded over thread  26 ) on a far side of a tissue wall (from needle tube  36 ), may cause rotation and trapping (angular movement) of anchoring element  24 . When suture arms  52  may be pulled against anchoring element  24  (abutting it against the far side of the delivery hole), suture arms  52  may slide into longitudinal recess  50  and are trapped therein thus forming the T-bar like configuration shown in  FIGS. 3A-3B . As is further described herein below with respect to  FIGS. 4A-4J , this formed T-bar like configuration may enables an anchoring  24  delivered through a tissue wall to abut the far side of the tissue hole with the suture arms positioned through the tissue hole. 
     Additional exemplary anchoring elements  24 E- 24 H are shown in  FIGS. 3E-3H  respectively.  FIGS. 3E-3G  are isometric illustrations of exemplary anchoring elements  24 E- 24 G according to some embodiments of the invention. Embodiments of anchoring elements  24 E- 24 F of  FIGS. 3E and 3F  may include central elongated body  23  having a form of a tube. In  FIG. 3E  two recesses  50  are located on two opposite peripheral sides (e.g., above and below) of the tubular body. Recesses  50  in  FIG. 3E  and also  3 A- 3 D have wide end  51  of each recess  50  coincides with an end of the elongated body. In the embodiments of  FIGS. 3A-3D  length of each recess  50  may be shorter than half the length of the elongated body and/or the two recesses  50  may be symmetrically located from two ends of the elongated body. Embodiments of anchoring element  24 F illustrated in  FIG. 3 f    may include only one closed recess  50 . Embodiments of anchoring element  24 G of  FIG. 3G  may include an elongated body having a “spring shape”. Such an element may or may not be configured to compress when inserted into outer tube  22  and extend when exit end  38  of insertion device  12 . Element  24 G of  FIG. 3 g    may extend while anchoring threads  26  in the tissue, to further enhance the anchoring of the suture. In the exemplary embodiments of  FIGS. 3A-3E and 3   g  two recesses  50  may have substantially the same shape. Alternatively, each of the two recesses may have a different shape. Anchoring elements  24 E and  24 G may not be threaded on guide tube  46  or thread  26  while in the insertion device  12 . The locking of anchor elements  24 E and  24 G may occur when exiting the distal end  18  while thread  26  may be located in a contour shape on outer tube  22  outlet  38 . 
     In some embodiments, anchoring elements  24 ,  24 E- 24 F and  24 H may further include a fin element  55 , illustrated in  FIGS. 3E-3F and 3H . Fin element  55  may have several functionalities. Fin  55  may by attached to advancing mechanism  45 , such that elongated pusher  49  may push fin element  55  thus causing elements  24 E- 24 F and  24 H to advance forwarded in outer tube  22 . Fin element  55  may slide inside elongated slit  39  in needle  36  (or a slit in any other tube included in device  12 ), thus ensuring that element  24  may always have the same orientation (prohibiting element  24  from rotating inside tube  22  or needle  36 ). When pushed out of insertion device  12 , fin  55  may assist element  24  to tilt inside the tissue and avoid slipping back out of the tissue. 
     In some embodiments, fin element  55  illustrated in  FIG. 3H  may form an angle a (e.g.,  90 ° or less) with the central elongated body  23  of anchoring elements  24 . In some embodiments, fin element  55  may elastically bend towards the central elongated body (the bending may either have plastic or elastic features), for example when inserted into outer tube  22  or needle  36 . In some embodiment the fin element  55  may be rigid. In some embodiments, anchoring element  24 H may be threaded on guide tube  49  or guided otherwise inside insertion device  12 . As anchoring element  24 H may be positioned inside insertion device  12  a sharp angle a formed by fin elements  55  of anchoring element  24  H may be facing inlet end (proximal portion)  14  (illustrated in  FIG. 1 ) of outer tube  22  opposite to outlet end (distal portion)  18 . 
     Reference is now made to  FIG. 31  which is an illustration of an anchoring element according to some embodiments of the invention. An anchoring element  24 I may include an elongated body  23  and a fin  55 . Fin  55  may be configured to be lift up for sliding inside a slit in one of the tubes included in insertion device  12 . Anchoring element  24 I may have a proximal space past the fin to allow advancing assembly  45  to hold anchoring element  24 I better on guide tube  34  and avoid its unwanted movements forward. This arrangement may stop anchoring element  24  from unintentionally (e.g., without being pushed) advancing further on the guide tube and to avoid accidental pushing of the element by the advancing assembly in the anchor&#39;s proximal part and not under the fin  55 . Additionally, this configuration may further cause a better sliding of the anchoring element while keeping the fin open. 
     Embodiments of apparatus  10  may include a plurality of anchoring element  24  aligned in an insertion device  12 , for example, in outer tube  22  or needle  36 . Each of the anchoring elements may include locking element (e.g., a recess or a tab) to lock a thread  26 . Insertion device  12  may be designed such that thread  26  may move freely within insertion device  12 . After the insertion of anchoring elements  24  to a tissue each anchoring element may lock a portion of the thread to form a suture loop. 
     Anchor element  24  may have a locking element to lock the thread during or after the ejection of the anchor element. On one embodiment, the lock may occur while anchoring element  24  is pushed distally over the guide tube  46  or towards the shaft outlet end  38  or when suture arm or arms  52  are pulled to cause a tension 
       FIGS. 4A-4J  illustrate delivery of a single anchoring element  24  (with attached thread  26 ) from distal end  18  of apparatus  10 . 
     Insertion device  12  may be positioned against the tissue thereby apparatus  10  in position. Actuation of handle  16  (or any other releasing device) may push (a pre-defined distance or several pre-defined distances) needle  36 , plunger  37 , ( FIG. 7A ) and/or advancing mechanism  45  (illustrated in  FIG. 10 ) thus causing advancing mechanism  45  to push at least one anchor element  24  over the guide tube  46  and onto the thread; needle  36  (or alternatively, anchoring element  24  and/or outer tube  22  having sharpened end) may penetrate the tissue to a predefined depth. The same or a second actuation of handle  16  may push plunger  37  to advance anchor element  24  towards the distal end or needle  36  or outer shaft outlet  18  and push advancing assembly  45  to release anchoring element  24  from needle  36  and into the tissue. The thread may be tensioned and trapped against anchoring element  24  which may in turn rotated (e.g., tilt and curved rout) and trapped against the inner tissue surface. Thread  26  may be anchored in narrow side  53  of at least one recess  50 . Handle  16  may be actuated again to distally push tube  34  thereby trapping thread  26  in slots  42  and to advance and/or rotate tube  28  thereby cutting thread  26 . Alternatively, thread  26  can be severed and/or held using scissors and/or grasper thereby omitting the need for tubes  28  and  34 . 
     Delivery of anchoring element  24  via the mechanism as described above is given as an example only, however, it will be appreciated that alternative delivery approaches which include rotation (torqueing) of anchoring element  24  into tissue or firing of anchoring element  24  into the tissue via, for example, a spring loaded firing mechanism are also contemplated herein. 
       FIG. 5A  illustrate a continuous suture (running stitch) composed of five contiguous anchoring element-thread loops positioned using for example, apparatus  10 , by repeating the steps outlined in  FIGS. 4A-4H  described above five times along a tissue  60 . Each of the thread loops illustrated in  FIG. 5A  may be adjusted with different suture loop width or suture depth in the tissue. The arrows point at tissue holes  62  formed by needle  36 .  FIG. 5B  is a magnified view of one anchoring element-thread loop. The thread length may be adjusted by the user based on tissue depth and tightness as well as distance between delivered anchor-suture loop. Anchoring elements  24  may abut in the tissue in any rotational orientation with the length of anchoring element  24  parallel to the tissue surface. Penetration into the tissue may be perpendicular or at any desired angle as long as anchoring element  24  may penetrate through the tissue wall and may be entrapped against its distal surface in any rotational angle. 
       FIG. 5C  illustrates an example of a degradable (e.g. bio-absorbable) anchoring element  24  or semi degradable anchoring element  24  (fabricated from degradable and non-degradable portions) connected to a suture loop within tissue  60 . Once anchoring element  24  degrades (partial degradation shown), the thread loop may maintain the shape and position shown due to tissue fibrosis around thread arms  52  and anchoring element  24  as well as fibrosis of tissue access site  62 . Thus, following complete absorption of anchoring element  24 , thread  26  may still provide the requisite fixation strength. In the case of a semi-degradable anchor, the non-degradable portion may further strengthen suture loop anchoring within tissue. 
     Following delivery of the anchor-suture loops, thread  26  can be cut as is illustrated in  FIGS. 41-4J and 6A-6B  or by external scissors. Any number of anchoring element-thread loops (e.g.  1 - 100 ) may be placed through a tissue wall. Thread ends of a single anchor or a series of anchors may be tied or left untied. 
     As is mentioned hereinabove, actuation of tubes  28 ,  34 , needle  36  and management of suture  26  may be effected via a mechanism disposed in handle  16 . 
       FIGS. 7A-7D  illustrate an exemplary embodiment of an exemplary mechanism  70  which may be suitable for use with apparatus  10 . 
     Actuation of trigger  70  may advance assembly  71  with respect to non-movable device  12  to pierce the tissue via needle  36  as is shown in  FIGS. 4A-4B . The movement of assembly  71  may include simultaneous movements of assembly parts, device  12  does not move. 
     Spring  72  may be compressed as a result of forward movement of assembly  71 . Actuation of trigger  73  may deliver an anchor-suture loop by pulling lever  79  that in turn may pull rack  75 . One of the teeth in rack  75  may push leaf spring  77  distally which in turn may push element  76  ( FIG. 7B ). This may cause leaf spring  78  to skip a tooth of the serrated inner surface of assembly  71 . This may prevent element  76  from going backwards when trigger  73  is released thus keeping the pusher in place and first (distal) anchor aligned with the distal end of tissue piercing tube  36 . Actuation of trigger  73  may also compress spring  74  which may expand when trigger  73  is released to return rack  75  to its starting position with leaf spring  77  skipping a tooth in rack  75 . 
     Release of trigger  70  may return apparatus  10  to its initial position to enable another cycle of tissue piercing and delivery of anchor-suture. 
     As is mentioned herein, apparatus  10  of the present invention can be used to fixate an implant to a tissue wall in a procedure such as hernia repair. 
     Laparoscopic hernia repair is an intra-abdominal, intraperitoneal repair that utilizes a mesh prosthesis to secure and cover a hernial defect; the hernia defect itself is usually not closed, though there are cases where the defect is suture or its contour is reduced. Traditionally, the mesh is anchored and held in position with trans-facial mattress sutures ( 2 - 0  or  0 ) provided at each corner of the repair. Typically, four mattress sutures are used, but for larger repairs eight or more mattress sutures are placed at 5 to 6 cm intervals. The sutures are tied subcutaneously through a small stab incision in the skin. In between the mattress sutures, the mesh is tacked or stapled to the abdominal wall fascia at  1  cm intervals with special hernia staples or spiral tacks. 
     In some embodiments, apparatus  10  may be used to repair an abdominal hernia as follows. A cannula may be positioned several centimeters away from the nearest border of the hernia, preferably at the midline. Pneumoperitoneum may be established and an angled (30 or 45 degrees) laparoscope may be inserted to facilitate insertion of the other trocars. A single 5 mm or 10 mm trocar and optionally one or two 5 mm trocars or one or two three mm ports or percutaneous micro-laparoscopy tools may be positioned through the abdominal wall as far laterally as possible from the hernia. Next, grasping forceps and scissors may be used to reduce the hernia, and outline the defect in the fascia. For optimal exposure, the working ports may be positioned as far away from the hernia defect as possible. Since the mesh may overlap the defect by 3 to 4 cm, a very lateral or inferior position of the trocar site maximizes the view and efficiency of the procedure when the mesh is unrolled and deployed. Device  10  may be used to suture the defect or to reduce circumference of the defect. 
     The edge of the defect may be identified and marked on the skin and a piece of appropriately sized and tailored mesh prosthesis (with 3 to 5 cm cuff or margin lateral to the fascia defect in all directions) may be prepared and marked. The corners of the mesh may be marked to maintain the proper orientation when the mesh is sutured in place. The mesh may be inserted into the abdomen. The device  12  of apparatus  10  may be located above the hernia defect (outside the abdominal cavity) and may deliver at least one anchoring element  24  from the outside of the abdomen inside, passing the abdominal wall and the mesh. Fixating and/or adhering the mesh center and/or corners to the abdominal wall (from the inside) and in the right location where the hernia defect may be above the center of the mesh. At the end of the procedure, anchoring element  24  may be left behind or removed once the mesh is adhered and fixated. The apparatus  10  may be delivered preferably through a 10-5 mm port or a 2-3 mm incision or puncture (port-less) depending on the size and location of the hernia. The first corner of the mesh may be held using a grasper against the corner of the ventral defect. The distal tip of the present device may be pushed against the grasped mesh to penetrate the mesh and the tissue to a depth of 3-20 mm, depending on the thickness of the abdomen. Next, an anchoring element  24  may be delivered into the tissue as is described hereinabove. Apparatus  10  may then be pulled back to tension the suture, lock it more firmly into the anchor and apply additional rotation to the anchor into its final position against the distal surface of the abdominal wall. 
     Apparatus  10  distal tip may be moved to the next desired location for fixation along with the extended length of suture and the suturing step may be repeated. Typically, 1-4 anchors may be deployed from the present device at each corner of the mesh (connecting thread may be left or cut after final fixation). Alternatively, the corner fixation may be performed with 2 or more consecutive anchor elements at each corner and the thread may be severed once moving from corner to corner. Once corner fixation is completed, the mesh is further fixated to the abdominal wall using apparatus  10  or standard approaches such as double crown or the like. Alternatively, the mesh may be initially fixated at its four corners via standard trans-fasciae sutures or tacks and apparatus  10  may be used to perform additional fixation via single or running stiches. Alternatively, the suturing can be performed without fixation of the corners. The fixation of the mesh and advancing with the mesh fixation may be performed in any routinely order with one or more single or continuous stiches. Following fixation, the present device is removed from the abdomen and the access sites may be closed using apparatus  10  or any other approach known in the art. 
     Thus, the present invention may provide a tissue suturing device which may be used to approximate ligate and/or fixate tissue via open or minimally invasive procedures. Apparatus  10  may be used in ventral, umbilical, inguinal, or hiatal hernia repair, fundoplication, bariatric surgery via gastric sleeve, rectopexy and mesh or mesh-less assisted pelvic organ prolapse fixation, hysterectomy, myomectomy, abdominoplasty, mammopexy, rhytidectomy, meniscus repair or rotators cuff repair access site closure or any procedure which requires tissue to tissue or tissue to implant approximation/fixation or tissue/organ/device/implant lifting or holding or retracting. 
     Insertion device  12  of apparatus  10  may include a distal marker to ensure that the outer tube does not penetrate into the tissue, while needle  36  may include graduation marks to determine manual or one or more predefined depth of penetration. Additional markers may be positioned on outer tube  22  or tube  24  to enable visualization through imaging modalities or camera or to ensure that the device does not penetrate into the external tissue (e.g. the abdominal wall). Additional markers may be positioned on handle  16  indication the number of anchor elements  24  left in device  10 . 
     The invention may provide several distinct advantages over currently available tissue suture/ligation/fixation approaches: 
     (i) the apparatus  10  may be used to produce a single tissue fixation point or multiple contiguous fixation points easily and rapidly with no need for additional knot tying in any type of tissue including a bone; 
     (ii) tissue/implant is sutured/fixated/ligated via a thread thereby providing a robust and reliable connection; 
     (iii) delivery of a suture loop may do not require access to the far side of a tissue wall; 
     (iv) delivery of suture may be adjusted for tissue thickness on the fly, enabling continuous suturing of varying thickness tissues; 
     (v) force of ligation may evenly distribute between contiguous suture loops thereby minimizing the likelihood of tissue ischemia; 
     (vi) apparatus  10  may be used with permanent thread/anchoring element or biodegradable thread and/or anchoring element; 
     (vii) apparatus  10  may penetrate the tissue vertically or at any selected angle; 
     (viii) the anchoring element may not protrude above surface minimizing tissue adherence or perforations; 
     (ix) the suture covers more surface thus reducing the number tacks/anchoring elements/sutures needed and the risk of damaging tissue such as blood vessels, nerves etc.; 
     (x) apparatus  10  may be used with a mini-port or delivered directly through the tissue (port-less) thus reducing the risk of infections and scarring; 
     (xi) apparatus  10  insertion device may be flexible and articulated and thus the device working head (tip) may be easily positioned within anatomically confined spaces; 
     (xii) apparatus  10  may be delivered over a guide wire positioned within vascular tissue; and 
     (xiii) apparatus  10  may be used with a robotic surgical system which may actuate the device  10 . 
       FIGS. 7E-7F  illustrate embodiments of apparatus  10  having a flexible ( FIG. 7E ) or deflectable ( FIG. 7F ) insertion device  12  or curved towards shaft distal end  18 . Such apparatus  10  configurations can be used in endoscopic or laparoscopic procedures. The tubes of flexible device  12  may be fabricated from an alloy or a polymer and may be elastically or plastically bendable. Device  12  may be constructed from a series of interconnected links or from a slotted tube(s). Control wires may run the length of the shaft and enable deflection of device  12  from the handle. Apparatus  10  may also include more than one devices  12  attached to a single handle  16 . For example, a dual device  12  operable via a single handle  16  mechanism may be used to lay down a double suture line with simultaneously delivery of two anchoring elements a predetermined distance from each other. The devices may run parallel to each other or at a converged/divergent angle. In such a multi insertion device configuration, anchoring elements  24  can be connected in pairs, enabling release of one thread loop attached to two anchoring elements with every cycle. In such a configuration, the pair of anchors may be connected and the thread trapping mechanism following release may be optional. 
     Apparatus  10  may be fabricated using approaches well known in the art. For example, insertion device  12  and the tubes contained therein can be extruded or rolled from an alloy, while handle  16  can be fabricated from injection molded and machined components. 
     As used herein the term “about” refers to ±10%. 
     Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting. 
     EXAMPLES 
     Reference is now made to the following examples, which together with the above descriptions, illustrate the invention in a non-limiting fashion. 
     Example 1 
     Prototype Bench Testing 1 
     Initial experiments were performed with a prototype that includes the anchoring elements  24 , threads  26 and insertion device  12  in order to determine feasibility of delivering an anchored suture through excised tissue. A 0.8 mm O.D. hollow alloy 8 mm in length was curved at the tips to form a groove for locking the suture. The tube was also tapered at the ends to facilitate penetration through a tissue access site. Ten individual anchoring elements were threaded over a 2-0 silk thread and the thread with threaded anchors was inserted into a 10 cm long hollow needle with a sharp tapered distal end capable of tissue piercing. A rod was fitted into the needle through the proximal end to serve as a plunger for expulsion of a suture anchor. 
     A standard 4×4 cm poly-propylene mesh was used along with a 20×20 cm piece of bovine abdominal muscle as the tissue model. The mesh was placed over the tissue and the needle was inserted through the mesh and into the tissue (to a depth of about 3 cm). The plunger was then advanced within the needle (about 1 cm) thereby pushing one anchoring element out of the needle and into the tissue. The pusher and needle were retracted out of the tissue, leaving a loop of thread and a threaded anchoring element over it, in the tissue. The process of anchoring element-thread delivery was repeated several times. 
     Example 2 
     Prototype Bench Testing 2 
     A second prototype including handle was fabricated by 3D printing the handle and actuating mechanism and attaching it to concentrically arranged tubes ( FIG. 8A ). The prototype was tested by sequentially delivering several anchoring elements through a 3 cm thick foam board forming a running stitch ( FIG. 8B-8C ). The prototype was then used to deliver two anchoring elements (each with attached suture loop) through fascia of excised bovine muscle tissue to simulate fascia anchoring ( FIG. 9A ). The load capacity of a single anchor point exceeded 600 grams ( FIG. 9B ). 
     Reference is now made to  FIGS. 10A-10H  which are illustrations of apparatus  10  in several positions illustrating 8 steps in the insertion and/or delivery of a single anchoring element  24  using insertion device  12 .  FIGS. 10A-10H  shows the advancing and positioning of the various elements of apparatus  10  (with respect to each other), discussed and disclosed above during the insertion of insertion device  12  and the delivery of anchoring element  24  and thread  26  into the tissue. During the insertion of anchoring element  24  by insertion device  12 , element  24  may exit in tilt position from needle sharp end  40  and continue to tilt in the tissue as illustrated in  FIGS. 10E-10H  and discussed below with respect to the method of  FIG. 12 .  FIGS. 11A-11B  are illustrations of device  12  in two positions of performing delivery of a first anchoring element from a plurality of anchoring element inserted into device  12 . 
     Reference is made now to  FIG. 12  which is a flowchart of a method of suturing a tissue according to some embodiments of the invention. In step  122 , method according to embodiments of the present invention may include piercing the tissue while inserting to the tissue an apparatus for suturing, for example, apparatus  10 . Apparatus  10  may include an outer tube  22 , a thread  26  at least partially inserted inside outer tube  22  and at least one anchoring element  24 . In some embodiments, apparatus  10  may further include needle  36  for piecing the tissue. In order to pierce the tissue needle  36  may be extend beyond end  38  of outer tube  22 . Needle  36  sharpened end  40  may pierce the tissue, as illustrated in  FIGS. 10A-10C . Alternatively, outer tube  22 , guide tube  46  or anchoring element  24  may have a sharpened end for piercing the tissue. 
     In step  124 , embodiments of the method may include advancing at least one anchoring element  24  towards outlet end  38  of outer tube  22  to cause at least one anchoring element  24  to exit from outlet end  38  of outer tube  22  into the tissue such that at least one anchoring element  24  is anchored in the tissue and threaded on thread  26 , as illustrated in Figs. 10 E- 10 F. In an exemplary embodiment, advancing mechanism  45  may push fin element  55  of anchoring element  24  along the longitudinal axis of insertion device  12 . As illustrated in  FIGS. 11A-11B  a plurality of anchoring elements may be inserted into insertion device  12  one after the other. Advancing mechanism (e.g., pusher  49 ) may push each of elements  24  separately, for example, by pushing fin element  55 . Alternatively, advancing mechanism  45  may advance two or more anchoring elements simultaneously. 
     Fin element  55  of each anchoring element  24  may slide inside an elongated slit included in one of the elongated components of insertion device  12 . For example, fin element  55  may slide in slit  39  included in needle  36  (as illustrated in  FIGS. 10A-10H ). Alternatively, fine element  55  may slide inside a slit formed on outer tube  22 , trapping tube  34 , cutting tube  28  or guiding tube  46  (illustrated in  FIGS. 2A-2C ). 
     In some embodiments, advancing at least one anchoring element  24  towards outlet end  38  may include tilting at least one anchoring element  24  upon exiting outer tube  22 , with respect to the longitudinal axis of outer tube  22 . As can be seen in  FIGS. 10E-10F , pusher  49  may be flexible and may bend when exiting from end  38  via slit  39  in needle  36 . This bending may cause or help anchoring element  24  to tilt inside the tissue. In some embodiments, anchoring element  24  may continue to tilt in the tissue and advance in a curved rout after exiting insertion device  12 . Additional tilting may be caused by pulling the portion of thread arm  52 . In some embodiments, when tilted anchoring element  24  may move in a curved rout in the tissue. 
     In step  126 , the method may include causing thread  26  to be gripped by the locking element, for example, at narrow end  53  of recess  50 , or by tabs  25  included in anchoring element  24 , as illustrated in  FIGS. 3A-3B . In some embodiments, anchoring element  24  may include at least one recess  50  and thus, when manipulating thread  26  may cause thread to be gripped at narrow end  51  of recess  50  of the anchoring element. 
     Handle  16  may activate advancing mechanism  45  by, for example, pushing a button or a trigger in user interface  20 . 
     In some embodiments, the method may include pulling apparatus  10 , by pulling insertion device  12 , from the tissue such that thread  24  may be anchored in the tissue by at least one anchoring element  24 , as shown in the photographs of  FIGS. 8B and 9A . 
     In some embodiments, the method may further include causing anchor element  24  to be anchored in the tissue, for example, by puling thread  26 . 
     In step  128 , the method may include repeating operation  122 - 126 , to form a plurality of sutures, also known in the art as running stich. Such an embodiment was disclosed above with respect to  FIG. 5A . 
     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 
     While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.