Instructions For Use
This is not a primer of surgical techniques.
- Using standard techniques, define the hernia defect. Tissue clearance of 5cm around the margins of the defect is recommended.
- Mark the long axis of the prosthetic material (mesh) and insert the mesh for fixation to the abdominal wall / soft tissues.
- No pre-placement of sutures is needed but short absorbable sutures on mesh corners allow easy grasping/manipulation of mesh.
- Make a 2-3 mm skin incision at each of the planned T-ANCHOR* suture placement sites.
- 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 of illustrations above).
- 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.
- Advance the Stylet to to push and deploy the T-ANCHOR* under direct/ laparoscopic visualization (Figure 3 of illustrations above).
- Withdraw Introducer Needle and the contained Stylet. The T-ANCHOR* is thus deployed.
- 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.
- Removal of a T-ANCHOR* that has been fired, is easy. It is grasped and removed trans-abdominally through the 10mm port.
- 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 of illustrations above). Placement of the T-ANCHORS*parallel to nerve pathways can avoid entrapment.
- 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.
- Position the suture knots securely in the subcutaneous tissue (Fig 4 of illustrations above).
- Place additional similar pairs of T-ANCHORS* along the perimeter of the prosthetic material to achieve desired fixation to the abdominal wall / soft tissues.
- Inspect the area carefully to assure proper T-ANCHOR* placement, prosthetic fixation and hemostasis.
- Dispose device materials according to biohazard precautions.
A Method of Use
- No pre-placement of sutures is needed but placement of short sutures on mesh corners allows easy grasping and manipulation of the mesh.
- The long axis and the center of the mesh are marked prior to insertion of mesh in to the abdomen.
- A T-ANCHOR* is inserted percutaneously through the center of the hernia to the center of the mesh and fired.
- The mesh is pulled up to the abdominal wall by pulling on the T-ANCHOR* Suture. This allows the mesh to be centered.
- The intra-abdominal pressure is lowered and the mesh is stapled / tacked.
- The central T-ANCHOR*, that was placed initially, is removed by grasping intra-peritonealy through the 10mm port and it is re-used!
- Additional Kumar T-ANCHORS® are placed in pairs to secure proper transfascial fixation of the prosthetic mesh as shown.
- The needle is so designed that it does not peel the mesh away from the abdominal wall during this step.
Please do read the detailed Instructions For Use prior to using this device
Proper fixation of Prosthetic Mesh is critical in repair of all Hernias. The ideal method for Fixation of the Mesh in Laparoscopic Repair of Abdominal Wall Hernia is a combination of tacking and Trans-fascial Sutures. Recurrence of Hernia is significantly lower if a combination of tacking and Trans-fascial Sutures is used for Mesh Fixation.
Previous Laparoscopic methods for placement of Transfascial Sutures use one of the Suture Passer devices. Grasping and feeding of sutures into the Suture Passer is technically difficult because of the lack of depth perception and lack of three dimensional (3D) visual feedback in laparoscopy. Pre-placement of sutures on the periphery of the Mesh results in a confusing bird’s nest like appearance when the Mesh is introduced into the abdomen and unrolled.
The Kumar T-ANCHORS®* provide an easy method for Trans-fascial Suture Fixation of Prosthetic Mesh without the need for grasping and feeding of sutures into a Suture Passer. The Kumar T-ANCHORS®* are to be used in addition to tacking
The Kumar T-ANCHORS Hernia Set *®
Mesh Fixation Made Easy
No Need to Grasp & Feed Sutures into suture passer
Provides trans-facial suture fixation of mesh to supplement the stapling and tacking devices.
Surgical Innovation, Vol 12, No 2 (June), 2005: pp xx–xx T1. Kumar, SS: Mesh Fixation in Laparoscopic Repair of Ventral Hernia: A New Method.
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Phone: 615-382-4996 Fax: 615-382-4199
See Descriptive Posters Below for Open and Laparoscopic Use
- The Kumar T-Anchors*® Hernia Set is a sterile single-use device that provides:
- 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 long 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 accomplished.
*Patents & ®Trademark
Warnings & Precautions
- The device is for use by qualified surgeons who understand the device, the operative procedures and the hazards.
- Inspect packaging prior to use. Do not use if packing is damaged or expired.
- Monitor the position of the Introducer Needle and T-ANCHORS* in the body tissues at all times carefully to avoid injury.
- Follow sharps precautions in handling and passing the device.
- 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.
- Wound Dehiscence.
- Gradual loss of strength over time.
- Infection and adhesions.
- Acute transient local inflammatory reaction irritation.
- Nerve entrapment between sutures.
- Irritation due to or protrusion of knots, if not sufficiently buried in the subcutaneous tissue especially in thin patients.
- Need for removal of broken T-Anchors during surgery is determined by the surgeon.
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.
*US Patent 6,996,916 and ®Registered Trademark
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.
The Kumar T-ANCHORS*® Hernia Set*
Frequently Asked Questions
Is it necessary to tack the Mesh if the Kumar T-ANCHORS*® are used?
Yes. The Kumar T-ANCHORS*® provide Trans-fascial Suture Fixation of the Mesh in addition to staplers / tackers.
Do the Kumar T-ANCHORS*® increase post-operative pain?
It appears that the Kumar T-ANCHORS*® cause less post-operative pain than conventional sutures because these do not form a complete circle around the tissues.
Can the Kumar T-ANCHORS*® cause Nerve Entrapment?
This is avoided by placement of each pair of T-ANCHORS* parallel to the expected course of the nerves. Also, as described above, complete nerve entrapment is avoided because T-ANCHORS* do not form a complete circle.
What if a T-ANCHOR* breaks?
Caution: The hemostatic tag to hold the T-ANCHOR* nylon suture should be applied at the suture end only. If the suture is grasped in the middle, crush injury may lead to breakage of the suture. Need for removal of broken T-ANCHORS* during surgery is determined by the surgeon. The material is bio-compatible.
Can the metal bars of the Kumar T-ANCHORS*® cause adhesions?
The exposed surface area of the T-ANCHOR* metal bar is only 1 mm sq. It lies buried in the Mesh. However, exposure of the T-ANCHOR* metal bar to the peritoneal cavity can also be avoided by placement of the T-ANCHOR* between the Mesh and the abdominal wall (See Diagram on front page).
How strong are the Kumar T-ANCHORS*®?
The Kumar T-ANCHORS*® comprise an MRI compatible metal bar attached to a 0 Nylon Suture. In laboratory bench testing, mean tensile strength of the T-ANCHORS* was 4.76 lbs.
Please Read the Detailed Instructions For Use prior to using this device.