Patent Description:
Suturing remains a common approach for repair of live tissue and is used for tissue closure, 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 (also known as "tacks"), 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.

In some ventral and incisional hernia cases, where the defect is relatively large (for example over a few centimeters), it is common practice not to suffice with mesh reinforcement but also to physically suture ("close") the abdominal wall at the site of the defect. The closure may be done extracorporeally or intracorporeally. Closure of such defects is known to significantly decrease the reoccurrence of the hernia, relative to reinforcement with just a mesh. For example, Zeichen et al. (<NUM>) showed that recurrence rates were threefold lower when closure was done in addition to mesh reinforcement.

<FIG> show three stages of hernia defect closure with mesh reinforcement, in accordance with prior art. <FIG> illustrates the large hernia defect in a cross-sectional view. <FIG> shows a top view of the defect being sutured in extracorporeal approach, after a mesh has already been affixed. <FIG> shows the final state, after the suture has been tensioned and knotted, and the mesh deployed and affixed underneath the fascia.

<CIT> to Fallin discloses a suture anchor assembly that is slidably received on a needle, and includes a proximal anchor, a distal anchor, and a suture extending therebetween. The suture is secured to the proximal anchor by forming a loop in the suture and passing the loop at least partially through a passageway in the proximal anchor. One end of the suture is then secured to the distal anchor, and the other end is passed through the loop and terminates in a free end to selectively lock the suture against the proximal anchor.

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. The invention is defined in appended claim <NUM>.

Embodiments according to the invention are directed to an apparatus for suturing tissue, comprising: an elongated shaft; a hollow needle disposed inside said elongated shaft, said needle having: an elongated slit which opens to a distal end of said needle, and an aperture disposed at a distal area of said needle; a handle disposed at a proximal end of said elongated shaft; multiple anchors disposed in a single file inside said needle, along the length of said needle, wherein each of said multiple anchors comprises: an elongated tubular body, a loop connected to said tubular body and exiting said needle through said elongated slit to a space between said needle and an inner wall of said elongated shaft, a fin emerging outwardly from said elongated tubular body, wherein a free end of said fin points toward the proximal end of said elongated shaft, and wherein the fin of the most distal anchor in the single file protrudes from said needle through said aperture; a thread disposed along the length of said elongated shaft, in the space between said needle and said inner wall of said elongated shaft, and threaded sequentially through said loops of said anchors; and a pushrod disposed in the space between said needle and said inner wall of said elongated shaft, wherein said pushrod is triggerable by said handle to push the fin of the most distal anchor in the single file, thereby to eject the most distal anchor in the single file from a distal opening of said needle.

In some embodiments, said loop is a cord emerging from an outer wall of said elongated tubular body, and terminating with a ring.

In some embodiments, said loop is a rigid wire having a proximal curl secured to said anchor, a straight section, and a distal curl through which said thread is threaded.

In some embodiments, the apparatus further comprises a push tube disposed inside the elongated shaft and over the needle, wherein the pushrod is attached to a distal end of said push tube, and wherein the triggering of the pushrod is by pushing said push tube distally.

In some embodiments, said handle comprises a trigger connected to a proximal end of said push tube.

In some embodiments, said pushrod is flexible and bends when passing through said aperture to push said fin.

In some embodiments, said fin emerges from said elongated tubular body opposite said loop.

In some embodiments, said handle is configured to allow said elongated shaft to retract into said handle while maintaining said needle stationary, so that a distal area of said needle is exposed and penetrates tissue.

In some embodiments, said handle comprises a shaft blocking lever that is movable between a position that blocks backwards movement of said shaft and a position that allows backwards movement of said shaft.

In some embodiments, said handle comprises a spool of thread.

In some embodiments, said handle comprises a trigger that is connected to said pushrod.

In some embodiments, the apparatus further comprises a push tube disposed inside the elongated shaft and over the needle, wherein the pushrod is attached to a distal end of said push tube, and wherein the triggering of the pushrod is by pushing said push tube distally; and a trigger comprised in said handle, wherein said trigger is connected to said push tube, such that depressing said trigger pushes said push tube distally.

Some embodiments are directed to an apparatus for suturing tissue, comprising: a needle having a beveled opening and housing multiple anchors, wherein each of said anchors comprises an elongated tubular body and a loop connected to said tubular body, and wherein a thread is threaded sequentially through the loops; and a pushrod configured to push each of said anchors towards the opening of said needle, to extract each respective anchor from the opening.

In some embodiments, each of said anchors further comprises a fin emerging outwardly from said elongated tubular body, wherein said pushrod is configured to push each of said fins towards the opening of said needle.

In some embodiments, said pushrod is sized to push each of said fins until the respective anchor completely exits the opening of said needle.

In some embodiments, the apparatus further comprises an elongated shaft, wherein said needle is disposed inside said elongated shaft.

In some embodiments, the apparatus further comprises a handle disposed at a proximal end of said elongated shaft.

In some embodiments, the apparatus further comprises a pushrod disposed in a space between said needle and said inner wall of said elongated shaft, wherein said pushrod is triggerable by said handle to push the fin of the most distal anchor in the single file, thereby to eject the most distal anchor in the single file from a distal opening of said needle.

In some embodiments, said handle comprises a trigger that is connected to a proximal end of said push tube.

In some embodiments, said needle has an aperture disposed at a distal area of said needle, said pushrod is flexible and bends when passing through said aperture to push said fin, and the fin of the most distal anchor in the single file protrudes from said needle through said aperture.

In some embodiments, said needle has an elongated slit which opens to a distal end of said needle.

In some embodiments, said loop exits said needle through said elongated slit to a space between said needle and an inner wall of said elongated shaft.

Some embodiments are directed to a method for closing an opening in a tissue, comprising: sequentially deploying anchors in the tissue, around the opening, wherein: (a) each of the anchors comprises an elongated tubular body, a loop connected to said tubular body, and a fin emerging outwardly from said elongated tubular body opposite said loop, (b) a thread is threaded through the loops of the anchors, and (c) the loops are partially exposed from the tissue, and the thread is completely exposed from the tissue; and pulling the thread, thereby approximating the loops, approximating the anchors, and closing the opening in the tissue.

Disclosed herein is an apparatus for suturing tissue, and a method for suturing tissue using the appartus, the method not forming part of the invention. The apparatus may be used, for example, for minimally-invasive hernia defect closure during a laparoscopic ventral hernia repair (LVHR) procedure.

Alternatively, the apparatus may be used for a different suturing task, such as, but not limited to, closing a laparotomy incision or performing other intracorporeal approximation or fixation. For reasons of simplicity, the disclosure describes the apparatus and method in relation to closure of a hernia defect, but those of skill in the art will recognize that these descriptions may apply, mutatis mutandis, to other suturing tasks.

Advantageously, the apparatus deploys multiple anchors that are structured in a way that: (a) prevents or mitigates damage to surrounding tissue, (b) allows the tissue to be closed by a convenient and simple pulling of a thread, after the anchors have been deployed satisfactorily, (c) enables strong fixation while not protruding outside the body, thus reducing risk of infection, (d) reduces tension on the sutured tissue (compared with regular, manual suturing) and thus reduces the risk of tissue trauma and thread 'cheese cuts', (e) does not form a loop that encapsulates tissue, and thus decreases the risk for nerve entrapment and reduction of blood flow to the encapsulated tissue, (f) enforces standardized suturing thus reduces the variability between surgeons of different skill levels, (g) reduces hernia recurrence rates while simplifying the procedure, (h) divides tension between all anchors, (i) when tensioning the thread, reduces friction of the thread with the anchor, by concentrating the friction of the thread on a smooth ring or loop, and (j) reduced the amount of artificial material that remains exposed from the tissue after the procedure, thus reducing adhesion risks. Namely, the apparatus facilitates the convenient formation of a continuous suture.

Reference is now made to <FIG> and <FIG>, which show a side view and a semi-transparent view, respectively, of an apparatus <NUM> for suturing tissue, in accordance with an embodiment. Apparatus <NUM> generally includes a handle <NUM> and an elongated shaft <NUM>. Only a proximal portion of shaft <NUM> is shown in <FIG>. Those of skill in the art will recognize that the apparatus may be readily adapted for use by a surgical robot; for example, the various physical actuators included in the handle may be structured in a way that allows electromechanical actuators of the robot to manipulate them.

Reference is also made to <FIG>, which show a distal portion of shaft <NUM> in various stages of the operation of apparatus <NUM>. Shaft <NUM> may have a length of, for example, <NUM>-<NUM> millimeters (mm), wherein part of this length is inside handle <NUM>. Shaft <NUM> may have an external diameter of, for example, <NUM> to <NUM>, and a wall thickness of, for example, <NUM> to <NUM>. Shaft <NUM> may have a uniform or a variable diameter along its length.

Handle <NUM> may include one or more user-operable actuators, such as, but not limited to, a trigger <NUM>, a cam shaft <NUM>, and a spool 120a. These user-operable actuators may serve to activate an anchor advancement mechanism disposed in handle <NUM> and/or in shaft <NUM>, whose role is to deploy multiple anchors from apparatus <NUM> into tissue.

Shaft <NUM> may be an elongated tube, either (a) rigid (for use in laparoscopic procedures), (b) rigid with a bended angle or flexible (for use in either laparoscopic or endoscopic procedures), or (c) rigid with controllable articulation capabilities - either at one or more manipulatable joints, or along entire segment(s) of the shaft. Shaft <NUM> may be made, for example, of plastic and/or metal.

A hollow needle <NUM> having a sharp (optionally beveled) edge <NUM> may be disposed inside shaft <NUM> longitudinally. Needle <NUM> may have the same length as shaft <NUM> or a different length. Needle <NUM> may have an external diameter of, for example, <NUM> to <NUM>, and a wall thickness of, for example, <NUM> to <NUM>. Shaft <NUM> may have a uniform or a variable diameter along its length. Needle <NUM> may be made of stainless steel or any other suitable material. There may be one needle inside the shaft or multiple needles (shown on page <NUM> of Appendix A). In the case of multiple needles, each may be used to deploy a single anchor, or, alternatively, each may be used to deploy multiple anchors.

Needle <NUM> optionally has a longitudinal slit <NUM> which extends from edge <NUM> to either a proximal edge (not shown) of the needle, or less than that. Slit <NUM> is shown as continuous slit, but in other embodiments it may be divided into multiple slits along the length of needle <NUM>. Slit <NUM> may be, for example, <NUM> to <NUM> wide. Its width may be uniform of variable along its length.

Optionally, needle <NUM> has one or more apertures <NUM> in its wall, that are optionally disposed on a side of the wall opposite slit <NUM>. If multiple apertures are present, such as a frontal aperture 124a and a dorsal aperture 124b, they may be equidistantly or non-equidistantly disposed.

<FIG> are top and bottom perspective views of needle <NUM>, in which slit <NUM> and aperture <NUM> are more clearly visible.

Optionally, needle <NUM> has one or more anchor stoppers <NUM>, embodied as resilient protrusions from an inner wall of the needle into the lumen of the needle - thus decreasing the inner diameter of the needle at that location. Stoppers <NUM> may normally protrude into the lumen of needle <NUM>, but may be pushed completely or partially out of the lumen when an anchor (further discussed below) applies on it a sufficient amount of force. Stopper <NUM> may be constructed such that it can resist a predetermined amount of force.

Multiple anchors <NUM> may be disposed in a single file inside needle <NUM>. Each of anchors <NUM> may have an elongated tubular body made of a rigid material, such as stainless steel, nitinol (nickel-titanium alloy), and/or plastic (permanent, such as polyether ether ketone, or bioabsorbable, such as poly(lactic-co-glycolic acid)). The tubular body may have a diameter of, for example, <NUM>-<NUM> millimeters (mm), a wall thickness of, for example, <NUM> to <NUM>, and a length of, for example, <NUM>-<NUM>. Alternatively, the anchor may have a solid cylindrical body, or have a different shape which is substantially elongated, such as a rectangular box or the like.

A loop may be connected to, attached to, or integrally formed with the tubular body of anchor <NUM>, such as a loop of wire or a different material. For example, the loop may be embodied as a cord <NUM> that emerges from the outer wall of each anchor <NUM>. Cord <NUM> may be a surgical thread (sometimes referred to as a "surgical suture"), or a flexible or rigid rod (straight, curved, spring-coiled, etc.) made of a suitable material such as stainless steel, nitinol, plastic, etc. Cord <NUM> is optionally also tensile, with such tensile strength allowing up to approximately <NUM>% to <NUM>% elongation without plastic deformation. Such tensile properties of cord <NUM> may further reduce tension from the tissue in which anchor <NUM> is implanted, when the thread is pulled and tensioned. Cord <NUM> may have a circular profile or a non-circular profile. Cord <NUM> may be attached to, connected to, or integrally formed with anchor <NUM>. Cord <NUM> may have a diameter of, for example, <NUM>-<NUM>, which may be uniform of variable along its length. Optionally, cord <NUM> is doubled over itself, such that there are in fact two cord segments extending between the outer wall of anchor <NUM> and a ring, which is described below. Cord <NUM> may be attached to, connected to, or integrally formed with anchor <NUM>.

Cord <NUM> may terminate with a ring <NUM>, or, alternatively, with a similarly-functional closed structure (not shown) that allows a thread to pass therethrough. Optionally, ring <NUM> is smooth and lacks any sharp edges, thus preventing or mitigating damage to the thread from friction with the ring. Ring <NUM> may be made of a rigid or flexible material, such as stainless steel, nitinol, or plastic. Ring <NUM> may be attached to, connected to, or integrally formed with cord <NUM>. Cord <NUM> may be rotatable around its longitudinal axis, to prevent thread loops (a thread <NUM> is discussed below) over ring <NUM>.

Alternatively, as shown in <FIG>, anchor <NUM> may have a loop of suture 114a, optionally with a protective cover 114b at its middle, to lower friction with thread <NUM>.

Further optionally, as shown in <FIG>, anchor <NUM> may have a rigid wire 114c as its loop. Wire 114c may be straight along most of its length, except in its (a) proximal area 114d, where it curls to form an arc of at least <NUM> degrees, the arc encircling a bridge 112a between two opposing elongated slits 112b in the tubular body of the anchors, (b) distal area 114e, where it curls helically or to about <NUM> degrees or more, such that the thread can pass inside this curl without escaping. If using a thicker thread, the curl may form an arc of less than <NUM> degrees, such as between <NUM> and <NUM> degrees. When anchor <NUM> is inside the needle, wire 114c may assume the position shown in <FIG> - substantially parallel to the longitudinal axis of anchor <NUM>. When anchor <NUM> is deployed in tissue and the thread is tensioned, wire 114c may assume the position shown in <FIG> - substantially perpendicular to the longitudinal axis of anchor <NUM>. Rigid wire 113c is optionally made of stainless steel, and has a diameter of between <NUM> to <NUM>, or more specifically <NUM> to <NUM>. The curl at the distal area 114e of rigid wire 113c is optionally tilted away from the anchor, so as to allow free pass of the thread through the loops of the anchors when the cord lies substantially parallel to the anchor inside the shaft. The tilting is optionally of an angle between <NUM> and <NUM> degrees, but could be to a greater or lesser angle.

<FIG> show a variant of the anchor of <FIG>, in which the rigid wire has a different configuration in its proximal and distal areas. In the proximal area, the wire has a closed or a nearly closed arc, namely - the distal end of the wire contacts or almost contacts the outer surface of the straight section of the wire. In the distal area, the wire forms a non-helical loop that is closes or nearly closed. <FIG> show the anchor with its wire positioned substantially parallel to the anchor, which is the posture the anchor assumes when it is inside the needle. 10F-<NUM> show the anchor with its wire positioned substantially perpendicular to the anchor, which is the posture the anchor assumes when it is within tissue.

<FIG> shows a further variant of the previously-shown anchors, in which the rigid wire is threaded, in its proximal area, through an aperture in the wall of the anchor. A bulge or a bend (not shown) at the proximal end of the wire prevents it from falling through the aperture. This wire is therefore able to rotate along its length axis, as the arrow shows. This may become useful after the anchor is implanted in tissue and the thread tensioned - the thread will rotate the distal loop of the wire to a position where there is the least amount of tension on the loop. This may lower the probability of disintegration of the wire due to the tension applied by the thread. In this variant of the anchor, the wire may also be flexible, so that it may resiliently lie flush with the anchor when inside the needle, and move angularly to the anchor after being extracted from the needle.

The elongated tubular body of anchor <NUM> may have a protrusion from its outer wall, which protrusion is disposed, for example, opposite where cord <NUM> emerges from the anchor. An exemplary protrusion is shown in the figures as a flexible or rigid fin <NUM>, which is a cutout in the wall of anchor <NUM>. When anchor <NUM> is made of a memory shape material, such as nitinol, fin <NUM> may be trained to protrude and emerge from the wall of the anchor. A free end 122a of fin <NUM> may point towards the proximal end of shaft <NUM>. When anchor <NUM> is in a position inside needle <NUM> where an aperture <NUM> is present, fin <NUM> may protrude away from the wall of the anchor, through the aperture. When anchor <NUM> is in a position inside needle <NUM> where no aperture is present, fin <NUM> may resiliently flatten, to lie flush with the wall of the anchor's tubular body. As an alternative to a fin which is cut out of the anchor body, another fin (now shown) may be attached or connected to the anchor body. As a further alternative, there may be, for example, multiple fins (e.g., <NUM>-<NUM>) that are disposed in different radial locations on or in the anchor body. Fin <NUM> may, for example, have a sharp free end, a blunt free end, or a toothed free end, etc..

A thread <NUM> may be disposed inside shaft <NUM>, along the length of the shaft, and optionally exiting a distal end 104a of the shaft. Thread <NUM> may be threaded sequentially through rings <NUM> of anchors <NUM>. Thread <NUM>, at its proximal area, is optionally wound around a spool <NUM> disposed in handle <NUM>. Thread <NUM> may be disposed inside the shaft so both ends are proximally located in the handle <NUM> or outside the handle, generating a thread loop inside apparatus <NUM>.

Thread <NUM> is optionally a surgical thread (sometimes referred to as a surgical "suture"), which may be bioabsorbable or non-bioabsorbable. Suitable bioabsorbable materials include, for example, polyglycolic acid, polylactic acid, monocryl, and polydioxanone. Suitable non-bioabsorbable materials include, for example, nylon, polyester, PVDF (Polyvinylidene fluoride), and polypropylene. Thread <NUM> may be a braided thread, a monofilament line, or a multifilament line. Thread <NUM> be made of metal or plastic, or of any biocompatible material. Thread <NUM> may be rigid or tensile.

Advantageously, the fact the present thread is not threaded through the bodies of the anchors but rather through the rings or loops that are distanced from the anchor bodies and are not embedded into tissue, prevents the thread from applying force to the tissue, which may, in extreme cases, even cut the tissue.

Furthermore, when the present thread is tensioned to finally close the tissue, the distancing of the rings from the anchor bodies reduces stress from the anchor bodies and concentrates that stress at the rings, and slightly along the cords.

Further yet, the use of anchors implies that there is a greater surface area implanted in the tissue and opposing forces which attempt to extract the anchors from the tissue. If only a suture were used, the only surface area securing the suturing were that the suture itself - which is very little.

In addition, the rings (or any other structure through which the thread is threaded) are structured such that they impose as little friction as possible on the thread. This way, when the thread is tensioned and secured, and following the entire recovery period, the rubbing of the thread over the rings' surface does not tear or otherwise degrade the thread.

An elongated pushrod <NUM> may be disposed along the length of shaft <NUM>, and be structured and disposed such that it terminates behind fin <NUM> of the distalmost anchor of the multiple anchors <NUM>, and can be advanced distally to push the distalmost anchor out of needle <NUM>.

Pushrod <NUM> may be a rigid rod which optionally has a bend whose convexity is pointed towards the inner wall of shaft <NUM>, or a flexible rod that is capable of bending similarly. Alternatively, the pushrod may be rigid and straight, and have a downwards protrusion at its distal end, that can be positioned behind the fin of the distalmost anchor (this configuration is not shown). In <FIG>, the bend is visible in the section of pushrod <NUM> which extends from a distal end of the pushrod to approximately the middle of the most proximal anchor <NUM>. This is merely one example; the bend in pushrod <NUM> may have such length, convexity and resiliency to allow it to push a distalmost anchor <NUM>, by its fin 122a, out of needle <NUM>, to a sufficient distance away from edge <NUM> of the needle such that the anchor tilts inside the tissue, until finally settling in the tissue approximately perpendicularly to the length axis of shaft <NUM>. The term "approximately perpendicularly" refers to an angle of <NUM> to <NUM> degrees, optionally <NUM> to <NUM> degrees. Optionally, the bend (and optionally other segment(s)) of pushrod <NUM> is resilient, such that when it is not biased by an external force (its delimitation between needle <NUM> and the inner wall of shaft <NUM>), it resiliently moves downwards and furthers the tilting of the distalmost anchor <NUM>. Pushrod <NUM> or at least its bend may be made of an elastic or superelastic metal, nitinol, or an elastomer.

Pushrod <NUM> may be sized so at to fit through the distalmost aperture <NUM> in needle <NUM>. This way, the distal end of pushrod <NUM>, when pushed distally, follows fin <NUM> into the lumen of needle <NUM>, and continues to move in a downwards direction to facilitate the tilting of the distalmost anchor <NUM>. Pushrod <NUM> may be linked to handle <NUM> via an optional push tube 126a, which is disposed inside shaft <NUM> and over needle <NUM>. Push tube 126a may terminate before apertures <NUM>, and pushrod may be attached to an outer surface of the push tube, at the distal area of the push tube. When handle <NUM> is utilized to push push tube distally, it in turn moves pushrod <NUM> distally. As an alternative to push tube 126a, the pushrod may extend all the way into the handle, in the space between the needle and the shaft (this configuration is not shown).

Pushrod <NUM> may either be the sole element responsible to deploy anchors <NUM> to their final location in the tissue, or be aided by a further element: an optional second elongated pushrod <NUM> ("advancer rod") which may be embodied as a rod disposed inside needle <NUM>, pushing anchors <NUM> from behind. When apparatus <NUM> includes advancer rod <NUM>, pushrod <NUM> may serve to push anchor <NUM> only slightly out of shaft <NUM> (e.g., until a proximal end of that anchor is <NUM> to <NUM> away from distal opening 104a of the shaft), and provide the anchor with an initial tilt in a direction opposite the pushrod. In <FIG>, this direction is downwards. The initial tilt may be to an angle of, for example, <NUM> to <NUM> degrees from the original posture of anchor <NUM> inside needle <NUM>. Then, advancer rod <NUM> continues to push that anchor <NUM> distally by pushing the anchors behind it, until the anchor is positioned sufficiently deep in the tissue (for example, between <NUM> and <NUM> inside the tissue). Due to the initial tilt of anchor <NUM>, the tensioning of thread <NUM> towards the handle, and the continued linear pushing by advancer rod <NUM>, anchor <NUM> continues to tilt as it penetrates deeper into the tissue, until it assumes an approximately perpendicular position.

As briefly discussed above, an anchor advancement mechanism may be disposed in handle <NUM> and/or in shaft <NUM>, whose role is to deploy multiple anchors <NUM> from apparatus <NUM> into tissue. The term "anchor advancement mechanism" is meant to refer to those particular parts of apparatus <NUM> that: push needle <NUM> distally, to expose a distal portion thereof out of distal end (also "opening") 104a of shaft <NUM>, and retract the needle back into the shaft (or, alternatively, retract the shaft while keeping the needle stationary, thereby exposing the distal portion of the needle); and push anchors <NUM> one at a time, to eject then out of distal end <NUM> of needle <NUM>. The anchor advancement mechanism may be triggerable by handle <NUM>, for example by having a user, such as a surgeon, operate one or more of the user-operable actuators, such as, but not limited to, trigger <NUM>.

<FIG> shows a distal-to-proximal view of shaft <NUM>, in which anchor <NUM>, fin <NUM>, cord <NUM>, needle <NUM>, push tube 126a, pushrod <NUM>, and anchor stoppers 128are visible. Also shown in this figure is a spacer <NUM>, which was omitted from <FIG> for better clarity of other elements. Spacer <NUM> may have the general shape of a disc, whose outer perimeters is in contact with the inner wall of shaft <NUM>. The disc has multiple cutouts that accommodate needle <NUM>, the loops, fins <NUM>, and pusher <NUM>. This is better shown in <FIG>, which is a perspective view of a distal area of shaft <NUM>.

In an embodiment, the apparatus lacks a needle, and the anchors are disposed directly inside the shaft. For example, the shaft may have an internal structure with spaces (e.g., interconnected lumens) for the single file of anchors, the fins, the pushrod that pushes the fins, and the loops.

In an embodiment, the apparatus lacks a shaft, and the needle is the outermost tube extending from the handle and inserted into the surgical site.

Apparatus <NUM> may be operated per the following method. This method is discussed as a laparoscopic one, but those of skill in the art will recognize that the same techniques may apply, mutatis mutandis, in medical procedures in which suturing is done not via laparoscopy.

With reference to <FIG>, apparatus <NUM> may be held by a grip <NUM> of handle <NUM>. Apparatus <NUM> may be pushed such that shaft <NUM> is introduced into a patient's abdomen through a small (e.g., <NUM>-<NUM>) incision. Shaft <NUM> may be either directly inserted through the incision, or indirectly through a trocar or another port. Alternatively, shaft <NUM> may be inserted through a natural orifice, with or without a later incision made to penetrate from the lumen of the natural orifice into a desired surgical area.

Optionally, while inserting shaft <NUM> into the body, a shaft blocking lever <NUM> may be positioned so as to block the shaft from retracting into handle <NUM>; a distal side of shaft blocking lever <NUM> is biased downwards using a spring, so that a shaft blocker 140c assumes a position being the proximal end of shaft <NUM>, blocking its movement in the proximal direction. A spring <NUM> may exert force on shaft <NUM> to push it in the distal direction. This state of handle <NUM> is shown in <FIG>. This figure shows the same elements of <FIG>, but at a different state.

Distal opening 104a of shaft <NUM> may then be pressed against the tissue, in a location where the surgeon wishes to deploy a first one of anchors <NUM>. In a hernia defect closure procedure, distal opening 104a of shaft <NUM> may be pressed against the peritoneum, a few millimeters up to a few centimeters from the defect.

Referring now to <FIG>, the surgeon operates handle <NUM> to activate the advancement mechanism, so as to expose a distal portion of needle <NUM> out of distal opening 104a of shaft <NUM>, such that edge <NUM> of needle <NUM> penetrates the abdominal wall tissue. This operation of handle <NUM> may first include bringing shaft blocking lever <NUM> to its up position, which raises shaft blocker 140c from behind shaft, allowing the shaft to retract further into the handle. Shaft <NUM> is retracted against the force of spring <NUM>, so that, if the surgeon releases the pressure of apparatus <NUM> against the tissue, the shaft will return to cover the exposed end of needle <NUM>, thus preventing potential damage to nearby tissues. Optionally, the penetration depth may be adjusted by rotating a nut <NUM>, which limits how far shaft <NUM> can retract into handle <NUM>.

Then, the advancement mechanism pushes pushrod <NUM> distally, in a force sufficient to push stopper <NUM> out of the distalmost anchor's <NUM> way, and cause that anchor to penetrate the tissue. This involves pressing trigger <NUM> (the depressed position of the trigger is not shown in the figures), which moves a connecting rod <NUM> distally, which moves distally a connector 148a that is attached to push tube 126a. Push tube 126a, in turn, pushes pushrod <NUM> distally.

When connecting rod <NUM> is moved distally, it also moves a ratcheted rack <NUM> distally, by a pin 148a that pushes forward a front protrusion 164a of the rack. One of the teeth of ratcheted rack <NUM> engages a base 130a of advancer rod <NUM>, and therefore advances advancer rod <NUM>. Each full trigger stroke <NUM> moves forward push tube 126a and pushrod <NUM> to a length equal to the length travelled by pin 148a, and advancer rod <NUM> by one increment. The distance between every two adjacent teeth of ratcheted rack <NUM> is optionally equal to the length of each of anchors <NUM>, such that advancer rod <NUM> pushes forward, with each increment, exactly the length of one anchor.

Trigger <NUM> optionally has a ratcheted surface 106a at its upper end, which engages a tooth <NUM> biased by a rubber band or spring106c (better shown in <FIG>, in which shaft blocking lever <NUM> is semi-transparent) when as the trigger is being pressed. This way, even if the surgeon ceases to press trigger <NUM> before completing a full stroke, the trigger remains in place and does not pop back out; it is held in place by tooth 106b. When a full stroke of trigger <NUM> is completed, ratcheted surface 106a moves forward away from tooth 106b, and the tooth disengages the ratcheted surface. Trigger <NUM> is then released, and tooth 106b slides over ratcheted surface 106a and allows the trigger to assume its original position.

When trigger <NUM> is released after a full stroke, a spring 146a that connects it to the handle's housing pulls the top part of the trigger downwards, causing the trigger itself to move forward, to its original position. Connecting rod <NUM> returns backwards and retracts pushrod <NUM> with it, while the backwards retraction of ratcheted rack <NUM> does not move advancer rod <NUM> backwards, despite the fact pin 148a pushes a rear protrusion 164b of ratcheted rack <NUM> backwards; the respective tooth of the ratcheted rack slides over base 130a and does not move it. A ratcheted bar 130b affixed to the housing of handle <NUM> ensures that base 130a cannot move backwards but only forward; a bottom area of base 130a includes a protrusion (not seen in this view) that suitably engages the ratcheted bar.

The rotation of spool 120a may be controlled by a cam shaft <NUM> that alternates between two positions: one which (a) pushes a top stopper <NUM> upwards and disengages it from a ratchet wheel <NUM> of spool 120a and (b) allows a bottom stopper <NUM> to move upwards and engage the ratchet wheel; and one which does the reverse, and optionally also pushes down the proximal side of shaft blocking lever <NUM>, such that its distal side rises and unblocks shaft <NUM> from retracting into handle <NUM>. The second position of cam shaft <NUM> may be selected by the surgeon after pressing the distal end of shaft <NUM> onto tissue, and in preparation for retracting the shaft so that needle <NUM> penetrates the tissue. In addition or as an alternative to controlling shaft blocking lever <NUM> from cam shaft <NUM>, it may be controlled by pressing and depressing a button <NUM> that directly presses and depresses, respectively, the distal side of the shaft blocking lever.

Each position of cam shaft <NUM> prevents rotation of spool 120a in one direction, and allows its rotation in the opposite direction. This allows the surgeon to control the release and retraction of the thread as necessary. Furthermore, the surgeon may utilize a knob 120b of spool 120a to manually rotate the spool in either direction, if the position of cam shaft <NUM> is suitably set.

Optionally, top stopper <NUM> is flexible so to allow rotation of spool 120a in both directions while making a clicking sound as its edge bounces on the toothed surface of the spool, providing auditory feedback to the surgeon on the rotation of the spool.

Simultaneously, thread <NUM> is optionally pulled from its distal free end, to further aid anchor <NUM> to reach an approximately perpendicular posture, or at least a posture which places the anchor's central axis at <NUM> degrees or more off the central axis of shaft <NUM>. <FIG> show this stage (in cross sectional non-cross sectional views), with the distalmost anchor <NUM> out of needle <NUM> and slightly tilted downwards. Pushrod <NUM> is shown passing through the distalmost aperture <NUM>, and extending to a distance of, for example, <NUM> to <NUM> from edge <NUM> of needle <NUM>. The pushing of anchor <NUM> (and the optional pulling of thread <NUM>) may continue until anchor <NUM> assumes an approximately perpendicular position inside the tissue (this position is not shown in <FIG>).

After successfully deploying the distalmost anchor <NUM>, the advancement mechanism may retract needle <NUM> into shaft <NUM> and pushrod <NUM> into needle <NUM>, and the surgeon may move apparatus <NUM> to a next location in which anchor deployment is desired. <FIG> shows needle <NUM> and pushrod <NUM> back in their original locations inside shaft <NUM>, ready to deploy the next one of anchors <NUM>. The surgeon may then reposition the shaft, and repeat operating handle <NUM>, in the manner described above, to deploy the next one of anchors <NUM>. This may be repeated until a desired number of anchors <NUM> has been deployed.

In a hernia defect closure procedure, the anchors may be deployed in such locations and such order to form a suitable pattern of tissue closure.

Reference is now made to <FIG>, which schematically illustrates three exemplary anchors <NUM> that were deployed in the abdominal wall. As shown, anchors <NUM> each assume an approximately perpendicular posture inside the tissue. In a hernia defect closure procedure, anchors <NUM> may be deployed, for example, into the muscle layer of the abdominal wall, and reside at a depth of, for example, <NUM> to <NUM> inside the abdominal wall, as measured from the fascial direction.

Since thread <NUM> was threaded through rings <NUM> when anchors <NUM> were inside apparatus <NUM>, they remain threaded therethrough also after deployment of the anchors. A distal end of thread <NUM> is also ejected from apparatus <NUM>, and the two ends 118a of the thread may be manually pulled together, which in turn pulls rings <NUM> and brings anchors <NUM> closer to each other. This is shown in <FIG>, in which anchors <NUM> are closer to one another, and the two ends of thread <NUM> are secured together using a securing element <NUM>. Alternatively, the two ends of thread may be simply knotted. The pulling the two ends 118a of the thread may further contribute to the anchors' <NUM> movement towards an approximately perpendicular posture.

As an alternative to pulling together the two ends 118a of the thread, a locking anchor may be deployed as the first and/or last anchor in the series. A locking anchor deployed as the first anchor may include a unidirectional or bidirectional locker, that prevents the thread from sliding unidirectionally or bidirectionally through the anchor. A locking anchor deployed as the last anchor may include a unidirectional locker, that allows only a tightening of the suture, e.g., to close the hernia defect. As an alternative to deploying such locking anchors into tissue, they may be only deployed over the thread but not in the tissue, such that their bodies, which are larger than the rings of the other anchors, are stopped at the rings. They may therefore be referred to simply as "lockers".

Reference is now made to <FIG>, which shows an exemplary unidirectional locking anchor. This anchor is structured as a tube, similar to anchor <NUM> of the previous figures, but has a tooth <NUM> that is bent inwardly, into the anchor's lumen. When a thread <NUM> is threaded through this anchor, a free end (not shown) of tooth <NUM> contacts the thread, and prevents it from moving to the left side of the anchor. If thread <NUM> is pulled to the right, however, it will easily slide over the free end of tooth <NUM>.

Reference is now made to <FIG>, which shows an exemplary bidirectional locking anchor. This anchor utilizes a locking slit <NUM> to prevent a thread <NUM> engaged in the slit from moving to either direction. Slit <NUM> may have a tapered shape, such that, when the left end of thread <NUM> is pulled backwards, towards the right end of the thread, the thread gradually enters deeper and deeper into the slit, until reaching very close to its end. There, the tapered shape of slit <NUM> presses on thread <NUM>, slightly compressing it at the contact area, and thus preventing its movement in any direction. Slit <NUM> is optionally tapered along its entire length. The tapering is optionally uniform along the entire length of slit <NUM>, or varies along this length. Advantageously, if slit <NUM> is tapered until its very end, thread <NUM> will tear if pulled with excessive force; the two sides of the slit will simply cut deeply into the thread until it rips. This serves as a safety mechanism, because the tearing of thread <NUM> under excessive tension will prevent the locking anchor from being pulled out of the tissue, severely damaging it.

Those of skill in the art will recognize that various other locking means may be employed at either side of a thread, to prevent the need to manually form a knot between the two opposing ends of the thread.

Reference is now made to <FIG>, which show an example of utilizing a unidirectional locker in a defect <NUM> closure task. In <FIG>, four anchors (represented by their rings <NUM>) are deployed in tissue in the following order: 212a, 212b, 212c, and 212d. A locker <NUM> is then positioned over the two ends of a thread <NUM>. Locker <NUM> is the slid over thread <NUM> while pulling the ends of the threads away. This results in the arrangement shown in <FIG>, where rings <NUM> are brought closer together, defect <NUM> is closed, and thread <NUM> is tightly held by locker <NUM>.

Reference is now made to <FIG>, which show another example of utilizing a unidirectional locker in a defect <NUM> closure task. In <FIG>, five anchors (represented by their rings <NUM>) are deployed in tissue in the following order: 220a, 220b, 220c, 220d, and 220e. A thread <NUM> is optionally tied to the ring 220a of the first-deployed anchor. Alternatively, a locking anchor may be the first-deployed anchor, such that no tying is required. Further alternatively, a stopper (not shown) may be attached to the end of thread <NUM> near ring 220a, such that the thread cannot detach from rings 220a. This may be, for example, a T-shaped bar whose leg is attached to the thread, and whose top shoulders are wider than the diameter of the ring and hence cannot escape it.

After deploying the last anchor, a unidirectional locker <NUM> is positioned over the free end of thread <NUM>. Locker <NUM> is the slid over thread <NUM> while pulling the end of the thread away. This results in the arrangement shown in <FIG>, where rings <NUM> are brought closer together, defect <NUM> is closed, and thread <NUM> is tightly held by locker <NUM>.

Reference is now made to <FIG>, which show a number of exemplary suturing patterns using the present apparatus. Each of these figures shows a defect, a suture, and multiple rings of implanted anchors (that are not shown). <FIG> shows a Z-shape pattern, <FIG> shows and X-shape pattern, and <FIG> shows a purse string pattern.

Reference is now made to <FIG>, which shows a variant of apparatus <NUM>, in which, instead of a single needle housed in a shaft, there is a multi-lumen shaft <NUM> that houses multiple needles. In this example, there are four lumens 252a-d that can accommodate four needles (not shown), but a different number of lumens and needles, such as between <NUM> and <NUM>, is explicitly intended herein. A central lumen <NUM> is also provided, which can contain the loops of the anchors positioned in the needles in lumens 252a-d. Each of lumens 252a-d also accommodates the other components acting together with the needle, such as a pushrod, an advancer rod, a push tube, etc. (all not shown).

An apparatus with a multi-lumen shaft <NUM> may contain a relatively large number of anchors, so that the apparatus does not need to be extracted from the body often to refill anchors or switch to another, full, apparatus.

Reference is now made to <FIG>, which illustrates how closing a defect with the present apparatus prevents nerve and/or blood vessel entrapment, compared with standard manual suturing.

At the top left of the figure, two anchors of the present invention are shown implanted in tissue on opposing sides of a defect, and a thread is used to approximate their loops and close the defect.

The bottom left of the figure illustrates a nerve or a blood vessel 304a in tissue 300a, enclosed between the two anchors and a thread 302a that connects them. Vessel 304a stays substantially intact, because there is only minimal pressure applied to tissue 300a by the wires of the anchors, and because the thread that connects the rings at the ends of these wires also applies minimal pressure to the tissue.

In contrast, when closing a defect by manual suturing with a surgical suture, as shown on the right top and right bottom of the figure, the tightened suture 302b presses radially on the tissue 300b are causes deformation, entrapment, or even closure of a nerve or a blood vessel 304b.

The inventors have tested an experimental apparatus, which was substantially identical to the apparatus disclosed here, on a sacrificed pig. A photograph of the anchor used in the test is shown in <FIG>, in turn, show photographs of different stages of the test.

A hernia defect was emulated by forming an approximately <NUM>-long tear <NUM>' in the animal's abdominal wall. In <FIG>, the shaft <NUM>' of the experimental apparatus is shown being pushed against the fascia in a first location. The free portion of the thread which exits the shaft is shown taught, as it was pulled aside by the tester. <FIG> shows the apparatus being pulled back after successful deployment of a first anchor. The free portion of the thread is now shown at the left side of the photo, and the portion that enter the shaft on the right side of the photo. The ring of the first anchor is shown at <NUM>'.

In <FIG>, the apparatus has been repositioned at the next location, now to the right of the tear. A second anchor was deployed at that location. Next (no photograph provided), a third anchor was deployed at the left side of the tear, at a certain distance from the first anchor.

<FIG>, which is a photograph taken at a larger magnification, shows the thread <NUM>' extending between the three respective rings <NUM>' of the deployed anchors.

<FIG> shows the tear closed, after the thread was pulled and tensioned, and the two edges of the tear were brought together by the anchors implanted laterally to the tear. The two edges of the thread were knotted in a central location between the rings.

Claim 1:
An apparatus (<NUM>) for suturing tissue, comprising:
(a) an elongated shaft (<NUM>);
(b) a hollow needle (<NUM>) disposed inside said elongated shaft, said needle having: an elongated slit (<NUM>) which opens to a distal end (<NUM>) of said needle, and an aperture (<NUM>) disposed at a distal area of said needle;
(c) a handle (<NUM>) disposed at a proximal end of said elongated shaft;
(d) multiple anchors (<NUM>) disposed in a single file inside said needle, along the length of said needle,
wherein each of said multiple anchors comprises:
an elongated tubular body,
a loop (<NUM>) connected to said tubular body and exiting said needle through said elongated slit to a space between said needle and an inner wall of said elongated shaft,
a fin (<NUM>) emerging outwardly from said elongated tubular body, wherein a free end (122a) of said fin points toward the proximal end of said elongated shaft, and wherein the fin of the most distal anchor in the single file protrudes from said needle through said aperture;
(e) a thread (<NUM>) disposed along the length of said elongated shaft, in the space between said needle and said inner wall of said elongated shaft, and threaded sequentially through said loops of said anchors; and
(f) a pushrod (<NUM>) disposed in the space between said needle and said inner wall of said elongated shaft, wherein said pushrod is triggerable by said handle to push the fin of the most distal anchor in the single file, thereby to eject the most distal anchor in the single file from a distal opening of said needle.