Indications for Use

Contraindications

The device is not indicated for use when laparoscopic and associated surgical techniques are contraindicated.

      A set of  Eight (8) MRI-compatible SS T-ANCHORS* with Non-Absorbable Polyamide (0 Nylon) Suture (USP) and

      A 15 cm long hollow Introducer Needle with a pusher Stylet

The horizontal limb of the “T” in each T-ANCHOR* consists of MRI-compatible SS 20 ga RW 1 cm tubing. The vertical limb of the “T” consists of a 22 cm long 0 polyamide (nylon) suture.

After the hernia defect has been defined and the prosthetic material is positioned for fixation, the T-ANCHORS* are deployed in pairs, with the aid of the Introducer Needle and pusher Stylet, at the planned suture fixation sites. Sutures of each pair of T-ANCHORS* are tied together. The knots lie in the subcutaneous tissue. Trans-fascial fixation of the prosthetic material to the abdominal wall soft tissues is thus achieved.

Suture Information Polyamide (Nylon) suture (USP) supplied in the Kumar T-ANCHORS™ Hernia Set* is size 0, non-absorbable mono-filament and composed of long-chain aliphatic polymers Nylon 6 and Nylon 6,6. It is dyed black with approved dyes, to improve visibility. It meets all requirements established by United States Pharmacopoeia (USP). It elicits a minimal acute inflammatory reaction followed by gradual encapsulation by fibrous connective tissue. While the suture is non-absorbable, gradual hydrolysis may result in loss of up to 20 % of tensile strength per year.

Instructions For Use

This is not a primer of surgical techniques.

1.        Using standard techniques, define the hernia defect. Tissue clearance of 5cm around the margins of the defect is recommended.. 

2.        Mark the long axis of the prosthetic material (mesh ) and insert the mesh for fixation to the abdominal wall / soft tissues.

3.        No pre-placement of sutures is needed but short absorbable sutures on mesh corners allow easy grasping/manipulation of mesh.

4.     .Make a 2-3 mm skin incision at each of the planned T-ANCHOR* suture placement sites.

5.        Remove needle guard from the Introducer Needle.  Load a T-ANCHOR* in to the hub of the Introducer Needle and advance it to two-thirds of the length of the Introducer Needle with the pusher Stylet. Leave Stylet in place (Figures 1 & 2).

6.       Advance the Introducer Needle through the skin incision site, at a 45-60 degrees angle, through the abdominal wall /soft tissues and through the mesh, 1 cm from its edge, under direct / laparoscopic visualization.

     Caution: The Introducer Needle tip and T-ANCHORS* must always be monitored laparoscopically and visually while in the body to avoid internal organ injury. The Introducer Needle carries visible 1 cm markings to allow monitoring of its depth.  

7.     Advance the Stylet to to push and deploy the T-ANCHOR* under direct/ laparoscopic visualization (Figure 3).

8.        Withdraw Introducer Needle and the contained Stylet. The T-ANCHOR* is thus deployed.

9.     Pull suture to hold prosthetic material against the abdominal wall.

      Caution: Apply hemostatic tag to nylon suture at the suture ends only. If the suture is grasped, with a hemostat, at the site where it exits from the skin, crush injury may lead to breakage of suture.

10.    Removal of a T-ANCHOR* that has been fired, is easy. It is grasped and removed trans-abdominally through the 10mm port.

11.     Load and advance a second T-ANCHOR* in a similar manner, through the same skin incision, at a 45-60 degree angle but in the opposite direction to allow creation of a musculo-fascial bridge over which the sutures will be tied. This second T-ANCHOR* is placed 1-2 cm away from the previous (Fig 3). Placement of the T-ANCHORS*parallel to nerve pathways can avoid entrapment.

12.     Tie the sutures of the pair of T-ANCHORS* deployed through the same skin incision. For good knot security, at least six flat square throws are recommended.

13.     Position the suture knots securely in the subcutaneous tissue (Fig 4).

14.     Place additional similar pairs of T-ANCHORS* along the perimeter of the prosthetic material to achieve desired fixation to the abdominal wall / soft tissues.  

15.     Inspect the area carefully to assure proper T-ANCHOR* placement, prosthetic fixation and hemostasis.

16.     Dispose device materials according to biohazard precautions.

A Proposed Method . Single T-ANCHORS* are placed percutaneously to anchor upper and lower ends (or the   corners) of the mesh to the abdominal wall. . The mesh is pulled up to the abdominal wall by pulling on the T-ANCHOR* Sutures. . This allows the mesh to be centered. . The intra-abdominal pressure is lowered and the mesh is tacked. . Additional T-ANCHORS* are then placed to make pairs for tying. The needle is so designed   that it does not peel the mesh away from the abdominal wall during this step.

Warnings & Precautions

1.        The device is for use by qualified surgeons who understand the device, the operative procedures and the hazards.

2.        Inspect packaging prior to use. Do not use if packing is damaged or expired.

3.        Monitor the position of the Introducer Needle and T-ANCHORS* in the body tissues at all times carefully to avoid injury. 

4.        Follow sharps precautions in handling and passing the device.

5.         Apply hemostatic tag to nylon suture at the suture ends only. If the suture is grasped, with a hemostat, at the site where it exits from the skin, crush injury may lead to breakage of suture.          

Adverse Reactions

How Supplied

The Kumar T-ANCHORS™ Hernia Set* is supplied sterile and for SINGLE procedure use only. Each unit contains 8 (eight) T-ANCHORS* along with an Introducer Needle (16 ga.) and pusher stylet. The 8 T-ANCHORS* allow for the placement of 4 fixation sutures.

Caution : Federal (USA) law restricts the use of this device by or on the order of a physician.    Only

Sterilization

The Kumar T-ANCHORS™ Hernia Set* is supplied sterile and for SINGLE procedure use only. Sterility is guaranteed unless package is opened or damaged.  DO NOT RESTERILIZE. If a package is opened and not used, discard properly.

*US Patent 6,996,916 and ™Registered Trademark

Nashville Surgical Instruments
Phone: 615-382-4996           Fax: 615-382-4199  
2005 Kumar Lane
Springfield, TN. 37172

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