Patent ID: 12239519

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to hernia repair and, more particularly, but not exclusively, to a method and apparatus for inserting, positioning and deploying a hernia repair mesh in the abdominal cavity.

A mesh, as referred to herein, relates to a mesh or patch used to repair a hole or hernial defect. Optionally, the mesh is formed by material surrounding closely spaced holes or openings. Alternatively, the mesh or patch is made of a homogenous fabric. In such a mesh, the holes or openings in the fabric may be invisible to the human eye. The fabric or material may be a polymeric composition or one or more of glass fibre; metal fibre such as titanium, stainless steel, nitinol (Nickel Titanium alloys); cardboard; natural fiber; polyester; polypropylene; silicone; rubber or rubber-like compositions. Optionally, the mesh has a coating on one side, for example a coating for preventing bowel adhesion when the (other side of the) mesh is attached to the abdominal wall. In an exemplary embodiment, the mesh and/or coating are bioabsorbable.

An aspect of some embodiments of the invention relates to a balloon removably attached to a mesh. A balloon, as used herein refers to an inflatable container of any size, shape or material. For example, the balloon can be made of one or more of rubber, latex, silicone, polyurethane, chloroprene, a nylon fabric and a thermoelastomeric material. The balloon can be made of biocompatible materials, non-bio absorbable materials, self-dissolving materials or shape memory materials.

In an exemplary embodiment, the balloon comprises an inflation tube which passes through the mesh. Optionally, the inflation tube is a flexible inflation tube. Alternatively or additionally, the inflation tube is stretchable.

An aspect of some embodiments of the invention relates to methods of hernia repair. In an exemplary embodiment, a balloon and mesh are inserted into the abdominal cavity via a trocar or via a laparoscopic opening. As used herein, the term laparoscopic opening refers to a trocar incision into the body. Optionally, a laparoscopic opening has a diameter of between 3-20 mm, between 3-18 mm or between 5-18 mm, for example about 3, 5, 10, 15, 18, 20 mm or more.

The balloon comprises an inflation tube which is preferably inserted with the rest of the balloon into the abdominal cavity. Optionally, the entire inflation tube is inserted into the abdominal cavity. In an exemplary embodiment, the inflation tube of the balloon is caught and the end not attached to the balloon is removed from the abdominal cavity through another opening, different than the laparoscopic opening. Optionally, the inflation tube is caught with a suture passer through the different opening. Optionally, the inflation tube is caught with a different grasping device through the different opening. Optionally, the different opening is smaller than a laparoscopic opening. The different opening may be made through the hernial defect or in the tissue immediately surrounding the hernia defect. Optionally, the different opening is substantially smaller than the laparoscopic opening. For example, the different opening can have a diameter of or less than about 1, 2, 2.5 or 2.9 mm. Due to the small size of the opening, the different opening is not harmful to the hernial defect and/or the tissue surrounding the defect.

In an exemplary embodiment the balloon is inflated, thereby deploying the mesh. Preferably, the balloon and mesh are positioned in the abdominal cavity by pulling on the inflation tube, optionally through the different opening, for example, a small opening in the hernia. In an exemplary embodiment the mesh is attached to the abdominal wall and the balloon is deflated and removed from the abdominal cavity. Optionally, the mesh is attached to the abdominal wall before deflation of the balloon. Optionally, the balloon is removed via the laparoscopic opening. Optionally, the mesh is attached to the abdominal wall using staples, tacks, sutures or other methods known in the art. In an exemplary embodiment the staples or tacks are provided to the mesh via open areas in the balloon and/or via surroundings of the balloon.

It is understood that if the tube is attached near the center of the balloon, then by pulling on the tube via the smaller hole in the hernia, the balloon (and the mesh) are automatically positioned on the hernia.

In an exemplary embodiment of the invention the balloon comprises at least one flexible coil attached thereto for removably attaching the mesh to the balloon. The term coil as used herein refers to a flexible and/or elastic object which is preferably retractable. Optionally, the coil is made of one or more of plastic, nylon, polyurethane and metal wire and has a spiral shape when retracted and a generally linear shape when stretched.

Optionally, the mesh comprises a plurality of closely spaced holes (or spaces between fibers for a woven mesh) and the wire has a diameter smaller than the holes or spaces. When stretching the coil, the spiral contour of the coil narrows, thereby decreasing its diameter. Optionally, the decreased spiral diameter is adapted to pass through the holes in the mesh. Alternatively or additionally, the narrow spiral assists in threading the wire through the holes of the mesh. Preferably, the wire diameter is smaller than the dimensions of the holes in the mesh.

Optionally, the balloon is removed from the mesh and abdominal cavity by pulling the balloon away from the mesh thereby removing said at least one coil from said mesh. Optionally, the balloon is attached to and removed from said mesh by attachment means as disclosed in PCT/IL2008/001381 filed on Oct. 22, 2008, published as WO 2009/050717, the disclosure of which is incorporated herein by reference.

In an exemplary embodiment, the inflation tube and/or coil comprise a stiff end, such as a needle, at its end for ease of penetration through the mesh. The stiff end is optionally made of one or more of plastic, metal, nylon and polyurethane. Optionally, the stiff end is cut off after penetration through the mesh. Optionally, the stiff end is not sharp enough to harm tissue or the mesh or the balloon, such that when the stiff end is not cut off after penetration through the mesh, the stiff end will not harm a tissue.

Alternatively or additionally, the inflation tube has a diameter adapted to pass through any of the holes of the mesh. Optionally, the mesh has a special opening at a central region thereof, adapted for insertion of the inflation tube.

In an exemplary embodiment the inflation tube further comprises a grasping appendage to enable grasping of the inflation tube in the abdominal cavity. Optionally, the grasping appendage comprises a loop. Alternatively or additionally, the grasping appendage comprises said needle. In an embodiment of the invention, a small opening is made in the hernia and the inflation tube is caught via the small opening and brought outside the body. After the mesh is positioned and preferably after it is attached to the abdominal wall, the inflation tube is optionally cut off near the abdomen.

Optionally, the mesh is situated only on one side of the balloon when the balloon is inflated. Alternatively, the mesh wraps around the borders of the balloon and is attached at the backside of the balloon, i.e. the side opposite to the side where the inflation tube is attached to, preferably only near the outer edges of the balloon. This enables the balloon to provide full support to the mesh when inflated and to deploy the edges of the mesh as well as the center thereof. Optionally, in this embodiment, the mesh partially wraps the balloon and the major portion of the mesh is at the front side of the balloon, i.e. the side facing the hernia.

In an exemplary embodiment of the invention, the inside of the balloon includes inflation fluid only. Inflation fluid, as used herein, includes liquid, gel and/or gas. Optionally, the inflation tube does not penetrate into the balloon.

In an exemplary embodiment, the area of the balloon in its deflated state is no larger than the area of the mesh. Optionally, the area of the balloon comprises no more than 70%, 50%, 20%, 10%, 5% or any intervening number, of the area of the mesh. Optionally, the balloon has a plurality of connected portions separated by open areas, the open areas comprising at least 70%, 50% or 30% of the extent of the balloon. The extent of the balloon, as used herein refers to the extent of a shape formed by the outermost edges of the balloon. The open area(s) refers to that portion of the extent that is not covered by the balloon material, when inflated. Optionally, the extent of the balloon is no larger than the extent of the mesh.

In an exemplary embodiment the balloon is wound into a roughly cylindrical shape before insertion in the abdominal cavity. Optionally, the balloon, with the mesh optionally attached thereto, is folded before winding in order to protect an optional coating of the mesh. Preferably, a non-adhesive coated portion of the mesh is folded on itself. It is noted that folding the coated mesh of the balloon enables the right side of the mesh to face the abdominal wall when deployed in the abdominal cavity. Optionally, the balloon has an asymmetric shape such that when folded the two folded parts of the balloon do not overlap, thereby providing a relatively thin construction of the folded balloon. This enables the folded balloon structure to be smaller.

Alternatively or additionally, the balloon can have any one of a branching shape, an eccentric shape, a concentric shape, a closed shape, an open shape, a symmetric shape, or any combination thereof.

An aspect of some embodiments of the invention relates to a winding device for winding surgical material before insertion into the body. Optionally, the surgical material comprises a mesh and a balloon attached thereto.

In an exemplary embodiment, the winding device is adapted for insertion through a trocar for insertion of the wound surgical material into the body. In an exemplary embodiment the winding device comprises two joined rods which can be separated for placing the surgical material between them. In an exemplary embodiment the winding device further comprises a handle on the distal end of the rods. Preferably, the winding device further comprises a knob on the proximal end of the rods. Preferably, the knob comprises two attached parts which can be dismantled in order to separate the rods and insert the surgical material between them.

Optionally, the handle can be deformed into an anchor which serves as a base for winding surgical material on the rods. Preferably, the anchor enables a surgeon or other single person to wind the surgical material on the rods, without requiring assistance. Optionally, the handle comprises two parallel parts, connected at their central portion and can be moved to form an anchor. Optionally, the anchor has an X-shape, a rectangular shape, a triangular shape or any other shape. Optionally, the parallel parts of the anchor comprise slits for anchoring the anchor to a tray or other base. In an exemplary embodiment, the handle can be removed from the distal end and attached to the knob at the proximal end of the rods. This enables easy gripping of the winding device for insertion into the body as well as clearing the path for the surgical material to be released in the body.

In an exemplary embodiment, the winding device further comprises a bearing between the handle and rods such that the rods can be rolled without moving the handle or anchor. Optionally, the joint between the handle and rods is bendable to ease winding the surgical material on the rods, when the handle serves as an anchor.

For purposes of better understanding some embodiments of the present invention are illustrated inFIGS.1-11of the drawings.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

FIG.1Aillustrates a balloon100in accordance with an exemplary embodiment of the invention. Balloon100comprises an inflatable body110and an inflation tube120. In an exemplary embodiment of the invention, body110has an asymmetric shape such that when the balloon is folded, as shown inFIG.1B, the two folded parts of the balloon do not overlap. The non-overlapping parts provide a relative thin construction of the folded balloon. This is advantageous when the balloon is wound for insertion through a trocar into the abdominal cavity. It is well known that it is easier to insert small devices through laparoscopic openings or trocars. The relatively thin construction of the folded balloon enables a thin construction of the wound roll and assists in the procedure.

Inflatable body110is shown having a plurality of connected portions separated by open areas150. Optionally, the open areas comprise more than 70%, 50% or 20% of the extent of the balloon. The extent of the balloon being defined as the extent of a shape formed by the outermost edges of the balloon, for example edges109inFIG.1A. Alternatively or additionally, the open areas comprise more than 30%, 50%, 70% or any intervening number of the area of the balloon in its deflated and/or inflated state. The open areas of the balloon also assists in providing a thin construction of the wound balloon for insertion into the abdominal cavity as referred to above.

In an exemplary embodiment, inflation tube120is flexible. Alternatively or additionally, the inflation tube is stretchable. Preferably inflation tube120is attached at a central region of inflatable body110. Optionally, inflation tube120is attached to an outer surface of body110and does not penetrate into the balloon, such that the inside of body110comprises inflation fluid only.

FIG.1Cis a closer view of inflation tube120in accordance with an exemplary embodiment of the invention. Inflation tube120includes a tube122and an optional grasping appendage124. Grasping appendage124is adapted to assist a surgeon in grasping the inflation tube in the abdominal cavity, optionally via a suture passer or other grasper inserted via a small hole in the hernia or in the tissue surrounding the hernia. Optionally, as shown inFIG.1C, grasping appendage124is a loop. Alternatively, grasping appendage124can be any other suitable grasping means known in the art. For example, a hook at the end of a rod can be used to grasp appendage124.

Optionally, inflation tube120further comprises a relatively stiff end126for providing smooth penetration of inflation tube120through the mesh. Stiff end126may comprise a needle or any other suitable sharp element. Preferably, end126is not sharp enough to harm the mesh or the balloon. In addition, end126is optionally not sharp enough to harm a tissue, such as the tissue in the abdominal cavity of the patient. Optionally, end126has a smaller diameter than tube122.

FIG.1Dillustrates a balloon111according to another exemplary embodiment of the invention. In this embodiment as well, the balloon comprises an asymmetric shape. In addition, the balloon comprises outermost edges107which provide support for a mesh attached thereto, while providing large open areas108, thereby providing a relative thin construction of the balloon when rolled. Balloon111may include an inflation tube similar to that of balloon100.

In an exemplary embodiment of the invention, balloon100or111is removably attached to a mesh with flexible coils, as shown inFIGS.2A-2H.FIG.2Ashows a balloon100having a plurality of coils112at its ends. In an exemplary embodiment, the balloon comprises at least one coil. Optionally, the balloon comprises four coils at its ends. Alternatively, the balloon comprises an additional set of coils114, which are positioned at a distance from its ends, as shown inFIG.2A. This enables meshes of different sizes to be attached to the balloon, using different sets of coils.

FIG.2Bis a closer view of coils112and114. Coils112and114are positioned at an extension136of balloon100. Coils112and114consist of a flexible coiling part130and an optional linear part132. Optionally, coils112and114also comprise a relatively stiff element134, such as a needle or a sharpened end of the optional linear part or the coiling part, for ease of penetration through a mesh.

As shown inFIG.2C, coils112are adapted to be penetrated through a mesh200. Mesh200comprises closely spaced holes202. For example, the holes are the spaces between adjacent warp and weft threads of the mesh or the holes are formed within the fabric of which the mesh is made of. Optionally, the wire used to produce the coils112, has a diameter adapted to pass through holes202, optionally, the diameter is smaller than holes202. Optionally, inflation tube120also has a diameter smaller than holes202and passes through the holes.

Optionally, when the mesh has a coated side, care should be taken that the coated side should face the balloon. This is since the coated side of the mesh should not face the hernia.

Coiling parts130are retractable and/or flexible and can optionally be stretched for penetrating through a mesh200as shown inFIG.2D. When stretched, coiling parts130reduce in diameter, thereby assisting in penetration-through the mesh. Preferably, coiling parts130are retractable and return to their original coiled shape after passing through mesh200, as shown inFIG.2E. The flexible characteristic of coiling part130also allows easy removal of the balloon from the mesh. By pulling the balloon, coiling parts130stretch and pass through holes202of mesh200, thereby removing balloon100from mesh200, without harming mesh200.

In an exemplary embodiment of the invention, linear part132and/or stiff element134are cut off after penetration through the mesh, as shown inFIG.2F. Optionally, stiff element126of inflation tube120is also cut off after being thread through the mesh.

FIGS.2G and2Hillustrates a different coil115which can be used to attach the mesh to the balloon in accordance with another exemplary embodiment of the invention. Coil115optionally also comprises a relatively stiff element117for threading through the mesh, similar to stiff element134of coil112discussed above. Optionally, coil115further comprises a vertical element118which is attached to the balloon, as shown inFIG.2D. Vertical element118preferably avoids the coil from sliding out of the balloon. It is noted that whileFIG.2Hdepicts balloon111, both coils112and115may be used with balloons110and111or any other balloon known in the art.

Coil115has a flat configuration which may be advantage for providing a thin construction of the rolled balloon.

Another exemplary embodiment of a construction for removably attaching balloon100to mesh200is shown inFIGS.3A and3B. In this embodiment, mesh200wraps around the edge of the balloon and is attached to a coil, for example coil112or115. The coil extends from the back of the balloon, i.e. the side opposite that from which the tube extends, as shown inFIG.3B. This embodiment enables greater support to the mesh, as opposed to the embodiment shown inFIG.2. Optionally, in the embodiment ofFIG.3, the major part of the mesh is at the front side of the balloon, which faces the abdominal wall, such that the mesh partially wraps the balloon.

It is noted thatFIGS.2and3are only exemplary means of removably attaching the balloon to the mesh. Any other fixating means known in the art may be used, such as sutures, Velcro, glue and/or any other fixation means disclosed in PCT/IL2008/001381 filed on Oct. 22, 2008, published as WO 2009/050717, the disclosure of which is incorporated herein by reference.

FIGS.4A-4Bare schematic illustrations of a folded balloon and mesh in accordance with an exemplary embodiment of the invention. Mesh200and balloon100are optionally folded such that inflation tube120is outside the folded structure. Flexible inflation tube120can then be positioned parallel to the fold, in order to be wound with the balloon and mesh, as described with reference toFIGS.5-7below. Optionally, the mesh has a non-adhesive coating and the mesh is folded such that the coated side of one half faces the coated side of the other.

FIG.5is a schematic illustration of a winding device500in accordance with an exemplary embodiment of the invention. Winding device comprises two closely positioned rods520and530. At a distal end522of rods520and530, a handle510can be attached. Optionally, handle510is T-shaped. In an exemplary embodiment, the top of handle510comprises two parts,512and514which can be deployed into an anchor as described inFIG.8. The anchor can have an X-shape, a rectangular shape, a triangular shape or any combination of shapes thereof.

Handle510optionally further comprises a bearing518enabling rods520and530to be rolled without rotating handle510. A flexible joint516is preferably provided between handle parts512,514and bearing518, allowing handle parts512,514to be moved with respect to bearing518thereby changing the angle between rods520,530and handle510.

At a proximal end524of rods520,530there is preferably provided a knob540for ease of grasping of the rods proximal end.

FIG.6is a flowchart of a method of winding surgical material on the winding device ofFIG.5.FIGS.7A-7Iare schematic illustrations of the acts listed in the flowchart ofFIG.6.

At602a winding device500and surgical material200are provided as shown inFIG.7A. Surgical material200will be referred to hereinafter as mesh200, however, it is understood that any other surgical material can be used. For example a folded balloon attached to a mesh as shown inFIG.4B.

Rods520and530, which are held tightly together, optionally by knob540, are released at604in order to insert mesh200between them. Optionally, knob540consists of two parts542and544which can be released, thereby providing an opening between rods520and530, as shown inFIG.7B.

An edge of mesh200is inserted through rods520and530at606, as shown inFIG.7C. Optionally, only a corner of the mesh is inserted through the rods. Rods520and530are pressed together to keep mesh200firmly captured between the rods, at608.FIG.7Ddepicts two ends542and544of knob540returned to its original position, thereby closing the opening between rods520and530.

Handle510is optionally attached to distal end522of rods520,530at610. This provides easy grasping of the handle when rolling rods520and530at612.

In general, three hands are required to wind mesh200on rods520,530. A first hand is used to roll rods520, by rolling knob540. A second hand is used to hold mesh to avoid wrinkles in the wound construction and a third hand should be used to grasp handle510to stabilize winding device500during the winding process. In conventional winding devices, handle510rolls with the rods and therefore makes it difficult for an assistant to hold the handle during the winding process.

In an exemplary embodiment, when bearing518is provided between rods520,530and handle510, the rods can be rolled without moving handle510. In this embodiment an assistant can help the surgeon in winding mesh200. One person rolls the rods by rolling knob with one hand, while his second hand holds mesh to avoid wrinkles in the wound construction. The other person can hold handle510to stabilize the winding device. Alternatively, handle510can also serve as an anchor such that no third hand is required, as described below with respect toFIGS.8A-8D.

FIG.7Fdepicts winding device500while mesh200is wound onto rods520and530. After winding mesh200, handle510is removed from the rods in order to clear the path for mesh200to be released into the abdominal cavity, at614. This is shown inFIG.7G.

In an exemplary embodiment, at616, handle510is then attached to knob540as shown inFIG.7H. Attaching handle510to knob540provides better grasping means and aids in maneuvering winding device500through a trocar into a laparoscopic opening and then releasing the mesh into the abdominal cavity. Optionally, knob540has a protrusion546at its end which fits into an aperture548of the handle, thereby attaching handle510to knob540, as shown inFIG.7LAlternatively, any other attaching means known in the art may be used, such as screws, velcro or glue.

At618, winding device500, with mesh200wound onto it, is inserted through a trocar into the abdominal cavity, as shown inFIG.11A.

FIGS.8A-8Dare schematic illustrations of a winding device800having a handle510which is used as an anchor in accordance with an exemplary embodiment of the invention.FIG.8Ais a different view of the optionally T-shaped handle510from that shown inFIG.7E. Handle510comprises two parts512and514attached with a hinge at their center513. InFIG.8A, parts512and514are placed parallel to each other and form a single arm. Parts512and514can be rotated away from each other and can be oriented substantially perpendicular to each other to form an X shape as shown inFIG.8B. It is noted that any other shape suitable for serving as an anchor may be used, such as a rectangular or triangular shape.

Optionally, parts512,514also comprise slits515. Slits515are optionally used for anchoring the handle to a tray810or other base as shown inFIG.8D. The edge of the tray810are passed into slits515, thereby anchoring handle510to tray810.

In an exemplary embodiment, there is further provided a flexible joint516between parts512,514and bearing518. Flexible joint516enables handle510to be rotated with respect to bearing518thereby changing the angle between rods520,530and handle510, as shown for example inFIG.8C. This is another feature that enables handle510to be anchored and stabilize winding device500during the winding process. With this embodiment, a surgeon does not require any assistance in winding surgical material onto rods520,530.

It is noted that winding devices500and800are only exemplary and the mesh200and balloon100can be wound without a winding device or by used of any other winding device known in the art. For example,FIGS.9A-9Nillustrate another winding device in accordance with another exemplary embodiment of the invention.

FIG.9Ais a schematic illustration of a winding device900in accordance with an exemplary embodiment of the invention. Winding device900is adapted to receive and wind surgical material100, and/or200. Winding device900consists of two bases902, connected by two rods901. A closer view of bases902is shown inFIG.9B.

Base902has a bottom layer903and a top905. Optionally, base902includes a tray910extending from top905, on which the surgical material can be placed. Base902preferably also includes an upper hole906and a lower hole908for placement of a spool904, as shown inFIG.9A. In an exemplary embodiment, device900consists of two spools904between which the surgical material is placed and then wound on. Resilient stoppers912are optionally provided between holes906and908. Resilient stoppers912keep spool904in upper hole906as shown inFIG.9Aand are adapted to open when pushed from the top, such that spool904can pass from upper hole906to lower hole908by pushing it down.

FIG.9Cis a closer view of spool904, depicting a rod914and a knob916. Knob916is preferably notched, such that a rod926of a second spool920(shown inFIG.9G) can be inserted in the notch. Optionally, knob916has a round shape as shown inFIG.9C. Alternatively, knob916has a hexagonal or other shape.

FIG.9Dshows winding device900with spool904placed in upper hole906and a slotted tube930placed below lower hole908, adapted to accept spool904after the surgical material is wound to it, when pushed to lower hole908. Optionally, tube930is elastic and spring-like. Ends932of tube930are positioned in grooves934in order to keep tube930in an open position. When tube930is pushed down, ends932are released from grooves934and tube930closes, as shown inFIG.9Land described below.

Winding device900is adapted to wind surgical material, such as mesh200and/or balloon100, as will be described below. The surgical material is inserted into a package950depicted inFIG.9A. Package950is adapted to keep surgical material100,200in place during the winding procedure and is preferably made of thin polypropylene. Optionally, package950is made of any other suitable material or combination of materials, such as nylon or metal, adapted to hold the surgical material. Package950preferably contains apertures952in its shape adapted to be inserted through top905of base902and extensions954adapted to be positioned on tray910. Optionally, package950is placed on top of surgical material100,200, and is not enclosing the surgical material. Alternatively, package extension954comprise slits955through which the surgical material is threaded, thereby secured in place.

Reference is now made toFIGS.9E-9Nwhere the procedure of winding surgical material with device900is shown.

FIG.9Eillustrates winding device900at a starting position, with surgical material100,200positioned on tray910(not visible since covered by the package). Second spool920is then added to device900, as shown inFIG.9F, such that the surgical material is positioned between spools920and904, as shown inFIG.9G. Spool920preferably has two knobs at its ends, adapted to be inserted into openings924in device900. Optionally, the device is configured such that when spools920and904are positioned as shown inFIG.9G, there is no space between the rods of the spools.

Surgical material100,200is then wound onto spools904and920, by turning knobs922, as shown inFIG.9H.FIG.9Idepicts surgical material wound onto spools904and920while positioned in upper hole906.

Spools904and920are then pushed to lower hole908, into tray930, as shown inFIG.9J. The spools are then pushed further down, whereby tray930is also pushed down, upon which edges932of tray930are released from grooves934and tube930is closed, having surgical material100,200wound onto spools904,920therein, as shown inFIG.9K. At this point, knobs916and922are removed from one end of spools904and920. This allows tube930to be removed from winding device900as shown inFIG.9L.FIG.9Mis a closer view of tube930with surgical material100,200wound therein. In an exemplary embodiment, tube930is adapted to be inserted into the body, optionally through a trocar. Alternatively, wound surgical material100,200is removed from tube930and/or spools904,920before insertion into the abdominal cavity. Optionally, the surgeon may release the wound surgical material100,200after the stage described inFIG.9Iand insert it to the body, optionally through a trocar. Alternatively or additionally, one of the knobs922also comprises a longer handle, to ease the winding and the insertion of surgical material100,200.

FIG.10is a flowchart of a method of treating a hernia in accordance with an exemplary embodiment of the invention.FIGS.11A-Iare schematic illustrations of acts of the method outlined inFIG.10.

At1020, the mesh and balloon are inserted into the abdominal cavity through a laparoscopic opening and/or trocar. Optionally, as shown inFIG.11A, mesh/patch200and balloon/inflatable container100are inserted while wound on winding device500or800or some other winding device, which is inserted through a trocar1100. Alternatively, a different instrument is used for carrying the mesh and the balloon, as shown inFIG.11B. Balloon100is not visible inFIGS.11A and11Bas the mesh is wound around the balloon.

Optionally, a second trocar1110is used as shown inFIG.11B. Second trocar1110is preferably used for insertion of optics, such as an endoscope in order to provide a view of the interior of the abdominal cavity to the surgeon. Optionally, trocar1110is used for laparoscopic surgical tools such as a grasper.

In general, it is preferred to make openings with as small a diameter as possible, to prevent creation of additional hernial defects. A trocar, as compared to suture passers or a tube catcher, has a relatively large diameter, usually between 3-18 mm. Therefore, trocars1100and1110are preferably inserted through laparoscopic openings at the side of the abdomen in order not to harm the wall at the already weakened defect.

At1030, the mesh and balloon are released inside the abdominal cavity, as shown inFIG.11C. Optionally, when the mesh does not slide from the winding device, the two parts542,544of knob540may be released as shown inFIG.11D. This creates an opening between rods520and530and assists in sliding the mesh and balloon from the rods into the abdominal cavity.

The inflation tube is grasped inside the abdominal cavity at1040. Preferably, a gripping device1130, such as a suture passer, is inserted through a small hole in the abdominal wall to catch the inflation tube, as shown inFIG.11E. An exemplary suture passer is EndoClose™ manufactured by Covidien—Auto Suture™. In an exemplary embodiment the gripping device creates an opening1140in the abdominal wall which is smaller than a laparoscopic opening and does not risk any danger to the abdominal defect, even when created through the abdominal defect. Optionally, opening1140has a diameter no more than 1, 2, 2.5 or 2.9 mm. Opening1140can be formed through the hernial defect or in the tissue surrounding the hernial defect.

Optionally, a grasper1120is also inserted through trocar1100and assists in bringing the inflation tube to gripping device1130. Alternatively, the optics could pass through trocar1100and the grasper through second trocar1110. As shown inFIG.11E, gripping device1130then catches loop124of inflation tube120and pulls inflation tube out of the abdominal cavity through opening1140at1050. Optionally, gripping device1130has a hook (not shown) at its end which is adapted to pass through loop124. Alternatively, other grasping means, for example a suture passer, can be used for catching loop124or any other part of inflation tube120.

At1055, the mesh and balloon are positioned at the hernial defect. In an exemplary embodiment, the balloon, with the mesh attached thereto, is positioned by pulling inflation tube120. By pulling inflation tube120, mesh200and balloon100are positioned close to the abdominal wall, substantially centered at the hernial defect. Optionally, hole1140is made through the hernial defect, thereby assisting in centering the mesh at the defect.

Alternatively, for example when the area of the defect is very thin, hole1140is made at the tissue surrounding the defect which is usually thicker. The mesh may then not be precisely centered at the defect, however, the mesh should still cover the hernial defect. Optionally, the balloon and mesh can also be oriented by rotating the inflation tube, thereby ensuring that the mesh will fully cover the hernial defect. Pulling on (and optionally rotating) the inflation tube from outside the body thus allows for convenient and accurate positioning and centering of the mesh at a desired, predetermined position.

The position of inflation tube120at a central region of the balloon is convenient for centering the mesh and balloon by the inflation tube. Alternatively, the inflation tube is not positioned at a center region of the balloon, but off-center to some extent, which may be advantageous when opening1140is made at the surrounding of the defect, thereby enabling the larger area of the mesh to cover the hernial defect.

Optionally, loop124is cut off the inflation tube after extracting the inflation tube from the abdominal cavity, thereby opening the tube for receipt of inflation fluid.

In an exemplary embodiment, a fastening adaptor1132, optionally provided with gripping device1130, is placed on the inflation tube in order to prevent the inflation tube from sliding back into the abdominal cavity. By fastening the inflation tube in place, the surgeon can also control the desired height at which the balloon and mesh should be positioned in the abdominal cavity. Optionally, any other fastening means, such as a clamp or kelly, can be used for fastening the inflation tube in place. Gripping device1130is then released and an injecting device or pump1150is attached to inflation tube120for inflating balloon100at1060. Optionally, the inflation fluid is a gas or gas mixture, such as air or CO2. Alternatively, any other inflation fluid, such as saline or any other liquid, may be used. Inflation of balloon100causes the balloon to deploy. Since the balloon is attached to the mesh, the deploying balloon provides a driving force to the mesh which also deploys and spreads as shown inFIG.11G.

Balloon100and mesh200are positioned close to the abdominal wall and as opening1140was performed through the abdominal defect or in the surrounding tissue of the defect, the mesh is situated at a predetermined position for repair of the hernial defect. Optionally, inflation tube120is pulled to place the mesh at the required position and orientation.

At1070, mesh200is attached to the abdominal wall. In an exemplary embodiment, as shown inFIG.11H, a tacker1160is inserted through trocar1100for fixating the mesh to the abdominal wall. Tacker1160may be any suitable tacker known in the art, such as ProTack™ of Covidien, SORBAFIx™ of Davol or Davol* PermaSorb™. Alternatively, the tacker may be inserted through second trocar1110, while optics is inserted through trocar1100. Alternatively or additionally, pins, claws, sutures, adhesive material or any other fixation means known in the art can be used for attaching mesh200to the abdominal wall.

In an exemplary embodiment, while the overall extent of the balloon is or may be almost comparable to the extent of the mesh, the area of balloon100is substantially smaller than the area of mesh200. Optionally, the solid area of balloon100is less than 10%, 20%, 30% or 50% of the area of mesh200. Optionally, balloon comprises a plurality of connected portions separated by open areas, the open areas comprising more than 30%, 50% or 70% of the area of the balloon in its deflated configuration. This enables the balloon to support the mesh while still having a substantially smaller area than the mesh. Optionally, the extent of the balloon is also smaller than the extent of the mesh. Alternatively, the extent of the balloon may be larger than the extent of the mesh.

Optionally said balloon is characterized by a branching shape, an eccentric shape, a concentric shape, an “H” shape, a rhomboid shape, a symmetric shape, an asymmetric shape, an open shape, a closed shape or any combination thereof.

Since the area of the balloon is substantially smaller than the area of the mesh, and much of the central portion of the mesh is accessible from the back of the balloon, the surgeon can relatively freely attach the mesh to the abdominal cavity, through the large open areas of the balloon without deflating or harming the balloon, while the balloon is still attached to the mesh.

This methodology allows for support of the mesh by the balloon and continued positive placement of the mesh by the balloon during attachment of the mesh to the abdominal wall. The continuing positive placement is also provided by the fastening adaptor holding the inflation tube in place. Since the balloon may have large open areas, the mesh can be firmly secured to the abdominal wall without attaching the balloon to the abdominal wall and without detaching the balloon from the mesh. Optionally, the balloon also has a smaller extent than the mesh, thereby enabling the edges of the mesh to be attached to the abdominal wall while the balloon is still attached to the mesh

Optionally, after attaching the mesh to the abdominal wall the balloon is deflated and removed from the mesh at1080. In an exemplary embodiment, the balloon is deflated by cutting inflation tube. In another exemplary embodiment, the injecting device1150is disconnected from the inflation tube120, thus deflating the balloon. Alternatively, injecting device1150is used for active deflation of the balloon. This can be performed either by changing the direction of a valve at the injecting device1150, by pulling a plunger of a syringe like injecting device or by changing the direction of the pump. In an exemplary embodiment, the balloon is removed by pulling the balloon away from the mesh, as shown inFIG.11I.

Optionally, inflation tube120is cut from the balloon after deflation, while the inflation tube is situated outside the body through opening1140. Optionally, inflation tube120is stretched before cutting, so that the inflation tube is cut as close as possible to the balloon. This is preferred in order to prevent any contaminated portion of the tube which is outside the body from re-entering the body after cutting and avoid contamination of the abdominal cavity. Alternatively, inflation tube120is removed along with balloon100through trocar1100or through the trocar's incision.

Optionally, the balloon is removed from the mesh before complete fixation of the mesh to the abdominal wall. This option is less preferred since the balloon, when connected to the mesh, provides support to the mesh and assists in keeping the mesh in place. Therefore, the balloon is preferably inflated and attached to the mesh during the fixation procedure. Optionally, the balloon is deflated after removal from the mesh.

At1090the balloon is removed from the abdominal cavity through trocar1100,1110or through the trocar's incision.

As used herein the term “about” refers to ±10%. The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”. This term encompasses the terms “consisting of” and “consisting essentially of”.

The phrase “consisting essentially of” means that the composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.

The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of“optional” features unless such-features conflict.

Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

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 subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.