Patent Description:
Hernias are structural defects most commonly involving the musculofascial tissues of the abdominal and pelvic regions within the human body. Most hernias eventually require surgical repair. Surgical repair of ventral incisional hernias may be accomplished via an "open method. " This method involves making a sizable incision directly over the tissue defect, separating the contents of the hernia away from the musculofascial defect, and repairing the defect primarily using sutures, or more commonly, sewing a graft to the defect edge in tension-free manner. This is done in an effort to minimize the recurrence of hernia formation which may occur with some frequency. The recurrence may be due to multiple factors including general health of the patient, surgical technique, and types of mesh or graft utilized. Overall, this traditional method is effective, but also often involves more pain, long periods of disability following the surgery, higher perioperative infection rates, and an established hernia recurrence rate.

Alternatively, ventral incisional hernias may be repaired using the "laparoscopic method. " However, this method has its own set of major shortcomings principally related to higher degree of difficulty in performing this procedure. One of the major challenges involve graft introduction into the abdominal cavity. Typically, a graft is rolled tightly into a cylindrical configuration and subsequently, pushed/pulled through the trocar which can be both time consuming and frustrating, especially when a larger graft is needed to cover the defect. This maneuver can also damage the graft during the delivery due to excessive force used or needed during the delivery process. Some surgeons also elect to place multiple sutures within the periphery of the graft for transfascial securement. This is often done prior to introduction of the graft. Once delivered into the abdominal cavity, the rolled graft/suture combination is unrolled, sutures isolated into respective corresponding abdominal quadrants, and the graft is centered over the defect prior to fixation. These steps are often very challenging and frustrating to accomplish in an efficient manner due to the pliable property of the graft and sutures which is a desired characteristic. <CIT> discloses a device for delivering a synthetic mesh or graft for anatomical repair at the defect site, with the synthetic mesh or graft in position for attachment to repair the defect. A plurality of spaced apart, flexible fingers is connected to the synthetic mesh or graft. The flexible fingers are initially in a position that is generally parallel to a direction of travel of the actuator. The actuator moves the plurality of flexible fingers from the initial to form a radial array, which opens or extends the synthetic mesh or graft. The synthetic mesh or graft may then be secured in place.

<CIT>, <CIT>, <CIT>, <CIT>, and <CIT> disclose similar devices.

The present invention is a device for delivering a synthetic mesh or graft for anatomical repair at a defect site. No surgical methods form part of the invention. A plurality of flexible arms is connected to the synthetic mesh or graft. Grasping jaws are individually controlled at or near a proximal end of the device for connection of the graft and release of the graft at the surgical site. The flexible arms, with graft attached are positioned through a surgical incision to the defect site. An actuator positions the flexible arms to assume a radial array at the surgical site, unfolding and spreading the graft for attachment. The length of each flexible arm is individually adjustable to adapt to the size and shape of the graft selected for installation at the defect site to repair the defect.

Turning now to the drawing figures, <FIG> shows an embodiment of a delivery device for delivering a graft or synthetic mesh for attachment to tissue. The term "graft" is used herein to indicate either a graft formed of biological material, or a synthetic mesh. The graft is connected to a plurality of flexible arms <NUM>. The flexible arms as shown in <FIG> extend from in a tube or shaft <NUM>. The flexible arms are shown as being generally parallel to a central axis of the shaft. Since the flexible arms are flexible, some bending of the flexible arms means that they may not be strictly parallel, but are generally parallel, to the axis of travel of the rack <NUM> of the actuator while the flexible arms are in the position shown in <FIG>.

<FIG> and <FIG> show the device for delivery of graft for attachment to tissue, according to an embodiment, prior to deployment of the graft. Control wires <NUM> are actuated to pull against sleeves <NUM> that surround a portion of the flexible arms <NUM>. The control wires extend through the shaft but may be external to the flexible arms as shown in <FIG> and <FIG>, or they may be internal to the flexible arms. The control wires are connected to the sleeves at or near a distal end of the sleeves and control wires. In a preferred embodiment, each of the plurality of control wires is associated with one of the plurality of the flexible arms. Upon actuation, the control wires pull against the sleeves at the point of attachment to the sleeves. The force of the control wires acting on the sleeves pulls the flexible arms from the position shown in <FIG> and into a radial array as demonstrated in <FIG>. The control wires are preferred to be nitinol wires, but the control wires may be formed of other metals, or plastics, textile materials or polymers, or similar materials having sufficient strength and flexibility.

As used herein, "proximal" is closest to the operator of the device and "distal" will typically be away from the operator and toward the patient when the device is in use.

The actuator construct shown in <FIG> B pulls the control wires <NUM>, moving the flexible arms <NUM> to form a radial array (<FIG>). This action unfolds the graft to a spread and generally planar position. In a preferred embodiment, when the travel of the actuator lever <NUM> is fully exhausted, the flexible arms may be positioned at an angle of somewhat more than <NUM>° from the axis of travel of the actuator, or the central axis of the shaft. <FIG> shows the flexible arms as positioned at an angle of more than <NUM>° from the central axis of the shaft. In some embodiments, this angle could be up to <NUM>° from the generally parallel position of the flexible arms shown in <FIG>. The actuator may be designed to allow the operator to set the desired angle. In some embodiments, the angle may be at least <NUM>° and perhaps more, so that the edges, or periphery, of the graft are pulled against the defect of the patient for subsequent securing or suturing of the graft.

According to one embodiment of the invention, the device may comprise a housing <NUM> having a trigger or actuator lever <NUM>. The housing may form a housing for the mechanism of the invention, including the actuator construct for the control wires <NUM>. At the distal end of the device is the plurality of spaced-apart flexible arms <NUM> that terminate at the connectors for the graft, which may be grasping jaws <NUM>.

The flexible arms <NUM> are preferred to be formed of a flexible cable. The cable may be a hollow cable formed of coiled or spirally-wound material which is capable of repetitive flexing and bending. The cable may comprise stainless steel suitable for use in surgical applications. The cables are sufficiently flexible to form the radial array shown in <FIG> when a force is applied by the control wires to the sleeves <NUM>, but return to a flaccid condition as shown in <FIG> as the control wires cease pulling the flexible arms to the radial array. The flexible arms are preferred to be flexible along their entire length, without having preformed bends or angles that may tend to dictate a path of travel as the flexible arms are withdrawn from the surgical site. The flexible cables used with the sleeves (that are also flexible) and the control wires allow the cables to follow the anatomical structure or host tissue, or a trocar, as a path of travel as the flexible arms are pulled away from the graft. The sleeves may also be formed of hollow cable that is constructed and arranged to surround the flexible arms as shown in the drawing figures. Rigid members, rather than flexible cables, may tend to resist removal, due to anatomical structure or host tissue interfering with the path of travel. The flexible arms and the sleeves are preferred to have shape memory that allows them to return to about the shape shown in <FIG> or <FIG> when the control wires are not actuated to apply a force upon the flexible arms,.

The embodiment as shown in <FIG> and <FIG> has four (<NUM>) flexible arms <NUM>. At least three (<NUM>), and preferably four (<NUM>) or more, flexible arms are employed. The flexible arms must be able to deploy and spread out the graft for attachment to tissue as shown in <FIG>.

The flexible arms are formed in a radial array by force applied by the plurality of control wires <NUM>. One control wire is associated with each flexible arm. The control wires pull against the sleeves <NUM> and the flexible arms to form the radial array. As shown in <FIG>, the flexible arms are substantially parallel to each other as they extend from shaft <NUM> of housing <NUM>. No substantial tension is applied to the control wires in this configuration. The device with graft attached may be inserted into the surgical site incision in this configuration.

In <FIG>, the control wires <NUM> are actuated to pull against the sleeves <NUM>, forming the flexible arms <NUM> into a radial array. In use, the graft <NUM> is positioned on the flexible arms and the graft expanded for attachment by movement of the flexible arms into the radial array.

In an embodiment as shown in <FIG>, the control wires are actuated simultaneously by the actuator construct contained in housing <NUM>. An actuation lever <NUM> engages and rotates the ideal gear <NUM>. The ideal gear <NUM> moves the rack gear <NUM> upwardly, applying a pulling pressure to the control wires <NUM> to form the flexible arms into the radial array. The ideal gear and the rack gear form a rack and pinion construct.

Latch <NUM> has interlocking members that engage with each other to hold the flexible arms in the radial array when the rack gear reaches its fully upward position. The interlocking members each comprises hook that interlocks with the corresponding hook. The graft is thereby held in a positon for surgical attachment. A flexible arm release lever <NUM> pushes an interlocking member of the latch away from an interlocking member that may be formed on the rack gear <NUM> to release the control wires. With no tension or pulling force on the control wires, the flexible arms return to generally the position of <FIG>. With tension released on the control wires, the flexible arms may be withdrawn through a trocar and/or surgical incision.

In the embodiment of the device shown in <FIG>, connectors <NUM> are positioned at or near the end of the flexible arms and are used to hold the graft for deployment. The connectors close upon the graft <NUM> to hold the graft. The connectors may be in the form of grasping jaws <NUM> in one embodiment that are actuated to close and open by pulling and releasing a connector strand, which may be a wire activation cable, or pull wire <NUM>. A connector actuator construct as shown in <FIG>, <FIG> and <FIG> communicates with the pull wire to open and close the connectors or grasping jaws for attachment and release of the graft. The connector actuator comprises a shuttle <NUM> in a preferred embodiment that ends with a control button <NUM> that extends from an end of the housing. The control button may be unitary with the shuttle, since depressing the control button (<FIG>) moves the shuttle to open the connectors or grasping jaws. In this embodiment, each control button and shuttle is associated with one flexible arm <NUM> and its associated grasping jaw. Each control button is associated with one grasping jaw. Actuating, or depressing, a control button associated with a grasping jaw causes it to open. Preferably, the control buttons are formed to individually lock the grasping jaws in an open position when the control button in depressed (<FIG>).

<FIG> is a top, sectioned view of the housing <NUM>, showing two compartments, with one compartment on each side. The compartments may be separated by a divider <NUM>. The lower compartment of the housing, when viewing <FIG>, contains the mechanism of <FIG> and applies a force to sleeves <NUM> by control wires <NUM>. This mechanism actuates the flexible arms <NUM> to pull the flexible arms into the radial array, or release the flexible arms.

The upper side of the housing as shown in <FIG> has a cavity <NUM> to store a portion of the flexible arms as the length of the flexible arms is adjusted for the specific application of a graft. The length of the flexible arms <NUM> may be adjusted by manually pulling or pushing the flexible arms into or out of the housing <NUM>. Cavity <NUM> of the housing stores excess length of the flexible arms. The length adjustment feature is useful to adjust the size of the arm array to the dimensions, and particularly the perimeter, of the graft, so that the radial array of the device fits the graft and pulls the graft tight, but not tight enough to deform the flexible arms of the radial array. A frictional braking device <NUM> (<FIG>) is preferred to be positioned near the entry/exit of the cavity <NUM> of the housing to apply friction to the flexible arms. The frictional braking device applies friction to each flexible arm that is sufficient to allow a length of each of the flexible arms to be pushed into or pulled from the housing, while preventing unwanted withdrawal or insertion of the flexible arms relative to the housing. The frictional braking device may be opposing sheets of vinyl, rubber, or similar compressible materials through which the flexible arms pass, and which applies a frictional force on the flexible arms. In a preferred embodiment, the frictional braking device has openings or conduits equal in number to the number of flexible arms. Each flexible arm engages one of the conduits and the conduit applies a frictional force to the flexible arm to retard but not prevent movement of the flexible arm into and out of the cavity as described. A cover of the housing may have protrusion(s) or boss(es) <NUM> formed thereon that applies pressure to deform the braking device and conduits for the application of frictional pressure to the flexible arms.

By the control wires <NUM> acting on the sleeves, with the flexible arms <NUM> being slidable relative to the sleeves <NUM>, the length of the portion of the flexible arms that extend from the distal end of the device may be altered while still providing a workable mechanism for forming the radial array irrespective of the length of each flexible arm that is chosen. Separate mechanisms are provided for controlling the length of the flexible arms and opening and closing of the grasping jaws on one side of the housing <NUM> and the actuation of the sleeves to form the radial array on the other side of the housing.

The graft <NUM> is attached about its perimeter to each of the flexible arms <NUM>. The graft is attached at spaced apart intervals so that the graft is formed in a radial array when the control wires are actuated. A portion of the graft is inserted between each open connector, which is a grasping jaw <NUM> in the embodiment shown. After insertion of a portion of the graft into the open grasping jaw, the grasping jaw is closed by releasing tension on the connector strand to hold the graft. The control buttons <NUM> are released from their locked positions by one or more release buttons <NUM>. In a preferred embodiment, the grasping jaws <NUM> each have a separate control button <NUM> and release button <NUM> so that the grasping jaws can each be independently opened and closed.

<FIG> shows housing <NUM> with flexible arms <NUM> attached to the grasping jaws <NUM>, and extending from the cavity <NUM> of the housing and though shaft <NUM>. This construct communicates with control buttons <NUM> to open the grasping jaws, which are normally closed. Anchor sites <NUM> for the flexible arms <NUM> are shown.

<FIG> is enlarged to show the detail of a preferred structure of the anchor sites. Shuttle <NUM> communicates with an associated control button <NUM> (not shown in this figure). A set screw <NUM> connects pull wire <NUM> to the shuttle. A compression spring <NUM> tensions the control wire to hold the grasping jaw closed. An anchoring collar <NUM> for the flexible arm is provided. Depressing release button <NUM> (<FIG>) allows the shuttle to be pushed proximally to compress the spring <NUM> and close the grasping jaws by providing tension on the pull wire.

<FIG> shows detail of an embodiment of the grasping jaws <NUM>. The grasping jaws may have an upper tooth <NUM> and a lower tooth <NUM> as shown, each of which pivot about a pivot pin <NUM>. The upper tooth and the lower tooth may be housed in the jaw housing <NUM>. A pair of pull wires <NUM> that may be internal to the flexible arm <NUM> contract to open and close. The grasping jaws are preferred to be normally closed. Springs <NUM> apply tension to the pull wires so that the grasping jaws are closed until the shuttle <NUM> via control buttons <NUM> push the springs forward to relieve tension on the pull wires.

<FIG> show the interaction between an embodiment of the shuttle <NUM> and release button <NUM>. As shown in <FIG>, the shuttle is pushed forward by pressing control button <NUM>. This action depresses spring <NUM> and opens the grasping jaw. An end of release button <NUM> engages an opening in the shuttle due to shape memory properties of the release button, locking the shuttle in place with the grasping jaw open.

Depressing release button <NUM> disengages the end of the release button. Spring <NUM> causes the shuttle to move from the position of <FIG> to the position of <FIG>. Expanded spring <NUM> applies tension to the pull wires <NUM> to close the grasping jaws <NUM>. In the embodiment shown, a release button <NUM> is provided for each flexible arm and associated grasping jaw. However, a bridge could be provided so that the grasping jaws may be universally closed at once. After the grasping jaws are closed on the graft <NUM>, the graft is held in place by the grasping jaws <NUM>. After surgical attachment of the graft, the control buttons are actuated to release the graft from the grasping jaws. The control wires <NUM> are also released from tension by the actuator construct, and the device is removed through the surgical site incision.

<FIG> demonstrates the graft being attached to the device. The grasper jaws are opened using the control buttons <NUM>. In this embodiment, the graft is connected at four (<NUM>) points to the flexible arms using the grasper jaws and generally about the perimeter of the graft. The grasper jaws are closed on the graft to hold the graft. The actuator is used to place the flexible arms in an orientation with the flexible arms generally parallel to each other for insertion through a trocar and into the surgical site.

A sheath <NUM> for facilitating insertion of the flexible arms and graft into the trocar and to the surgical site is shown. The sheath in this embodiment is a split tube that may be transparent or translucent. The sheath is preferred to be tapered, or have a frusto-conical shape that tapers or progressively reduces in diameter from left to right when viewed as in the drawing figures. A stand <NUM> holds an end of the sheath open at the split. A bullet shaped tool <NUM> having a diameter that is larger than the middle of the sheath may be used to slide from the end of the sheath that is adjacent to the stand and along the sheath to the opposite end, forcing the sheath to open about the split. The sheath is open at the split to a width that permits insertion of the flexible arms and the graft. The sheath, attached to the device, is placed into the sheath through the split. The sheath and the device are removed from the stand for insertion into a trocar.

<FIG>, <FIG> show a seal <NUM> mounted to the shaft <NUM>. The seal engages the trocar and the shaft to form a seal, inhibiting gasses from escaping the belly of the patient. An O-ring may be present about a circumference <NUM> of the seal to improve sealing.

In use, according to one embodiment, a section of graft <NUM> of appropriate size to repair the subject hernia is selected and/or formed. The graft may be formed (of various biological materials or, synthetic materials, including, but not limited to polypropylene or polytetrafluoroethylene (PTFE). The graft is connected near its perimeter to the connectors near the distal ends of the flexible arms. Each flexible arm is preferred to have a connector, such as grasping jaws <NUM>. The activation lever <NUM> is in the position shown in <FIG>, with the flexible arms positioned generally parallel to the axis of travel of the actuator. The graft is held by the flexible arms and folded. The graft is preferred to be covered by the sheath <NUM> for insertion into the trocar.

An incision in tissue <NUM> of the patient is made at the approximate center of the defect. Preferably, a trocar <NUM> is present within the incision. <FIG>The flexible arms of the device in a generally parallel orientation are inserted through the approximate center of the defect. The sheath <NUM> facilitates insertion of the graft <NUM> into the trocar, and protects the graft as it moves through the trocar to the surgical site. After the distal end of the device with graft attached travels through the trocar, and sufficient clearance through the defect <NUM> is obtained, the actuator, such as the gear train of <FIG>, is actuated causing the actuator to pull the control wires <NUM>, the flexible arms <NUM> and associated graft to the position shown in <FIG>. The graft is pulled up against the tissue by means of the handle of the device to cover the hernia defect <NUM>. Graft attachment to the tissue may be provided by known methods of attachment of grafts at surgical sites such as hernia defects. The procedure may be monitored by use of a laparoscope for proper positioning, and securing, of the graft.

The graft is formed to generally a planar form when the flexible arms form the radial array. As noted, the flexible arms may move through an arc that is more than <NUM>°. Therefore, the surface of the graft may be somewhat curved or non-planar, so that the edges or periphery of the graft is pushed against the tissue and secured to the tissue to cover the defect. However, the graft is still considered to be in a generally planar position.

Claim 1:
A device for delivery of a graft (<NUM>) for attachment to tissue, comprising:
a plurality of flexible arms (<NUM>) and a plurality of sleeves (<NUM>), wherein each sleeve of the plurality of sleeves surrounds a portion of one of the flexible arms of the plurality of flexible arms;
an actuator (<NUM>) , wherein movement of the actuator moves the plurality of sleeves and each sleeve of the plurality of sleeves moves the flexible arm it surrounds, and movement of the actuator forms the plurality of arms into a radial array;
wherein each of the flexible arms is slidable relative to the sleeve that surrounds it so that a length of a portion of each of the flexible arms that extends distally from the sleeve that surrounds it is adjustable;
wherein the plurality of sleeves (<NUM>) are in communication with the actuator (<NUM>), and move in response to movement of the actuator.