radially expanded, and tissues are stretched not cut. substantial axial force to penetrate the abdominal

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Sabrina Norman
5 years ago
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VersaStep* is not a sharp cutting trocar Conventional trocars can cut or tear tissue (vascular, With VersaStep*, the initial needle tract is non-vascular, fascial, muscular).

Axial force is required to thrust a bladed or anchors the cannula in place, enables easy expansion of access ports to larger sizes, and leaves slit- tapered cutting device downward through tissues

vessels, displacement/disruption of the tissue and incisional tissue trauma.

1 VersaStep* is not a sharp cutting trocar Conventional trocars can cut or tear tissue (vascular, With VersaStep*, the initial needle tract is non-vascular, fascial, muscular). Trocars require radially expanded, and tissues are stretched not cut. substantial axial force to penetrate the abdominal This effectively tamponades blood vessels, firmly wall. Axial force is required to thrust a bladed or anchors the cannula in place, enables easy expansion of access ports to larger sizes, and leaves slit- tapered cutting device downward through tissues which may cause one or all of the following: tenting like wounds that are approximately half the size of of abdominal wall tissue, severing of blood those created by comparably sized trocars. vessels, displacement/disruption of the tissue and incisional tissue trauma. VersaStep* is self-anchoring Following insufflation the expandable needle system is inserted, the needle is withdrawn, leaving the expandable sleeve in place. Radial traction helps to prevent cannula displacement. Conventional trocars, especially those used as operating ports, frequently become dislodged. This is particularly true during long procedures, resulting in loss of pneumoperitoneum. Repositioning displaced trocars requires reentry of a sharp trocar and reinsufflation of the abdomen, which is time consuming Radially expanding dilation results in stretching and compression of tissue fixing the VersaStep* cannula securely to the abdominal wall. A tapered blunt dilator is inserted through the sleeve, dilating the tract created by the needle... This self-anchoring feature virtually eliminates the likelihood of port displacement and re-entry of another sharp device. Rarely, if ever, does slippage occur with VersaStep*....leaving a working port securely in place.

2 Ordering Information All products are shipped sterile. All VersaStep* products are latex-free. REF Product Description Units per Box VersaStep* (100mm working length) S Insufflation/Access Needle, 14 Gauge 10 (Compatible with Step* and VersaStep* Access Systems) VS Radially Expandable Sleeve 6 VS mm Cannula & Dilator with Radially Expandable Sleeve 3 VS mm Cannula & Dilator with Radially Expandable Sleeve 3 VS mm Cannula & Dilator with Radially Expandable Sleeve 3 VS mm Cannula & Dilator 3 VS mm Cannula & Dilator 3 VersaStep* Short (70mm working length) S Short Insufflation/Access Needle, 14 Gauge 10 (Compatible with Step* and VersaStep* Access Systems) VS Short Insufflation/Access Needle, 14 Gauge 12 (Compatible with VersaStep* Access System) VS Short Radially Expandable Sleeve 6 VS Short 5mm Cannula & Dilator with Radially Expandable Sleeve 3 VS Short 11mm Cannula & Dilator with Radially Expandable Sleeve 3 VS Short 12mm Cannula & Dilator with Radially Expandable Sleeve 3 VS Short 11mm Cannula & Dilator 3 VS Short 12mm Cannula & Dilator 3 Short Mini Step (70mm working length) MS Short 2/3mm Cannula and Dilator with Radially Expandable Sleeve 10 VersaStep* Long (150mm working length) VS Long Insufflation/Access Needle, 14 Gauge 12 VS Long Radially Expandable Sleeve 6 VS Long 5mm Cannula & Dilator with Radially Expandable Sleeve 3 VS Long 12mm Cannula & Dilator with Radially Expandable Sleeve 3 VS Long 12mm Cannula & Dilator 3 *Trademark of Auto Suture, a division of Tyco Healthcare Group LP Tyco Healthcare. All rights reserved. S-VersaStep/GB Tyco Healthcare UK Limited 154 Fareham Road GOSPORT Hampshire PO13 0AS UK Tel: +44 (0) Fax: +44 (0) Tyco Healthcare Regional Export 154 Fareham Road GOSPORT Hampshire PO13 0AS UK Tel: +44 (0) Fax: +44 (0) Tyco Healthcare Nederland BV Hogeweg LL ZALTBOMMEL The NETHERLANDS Tel: Fax: TycoHealthNed@TycoHealth.com Tyco Healthcare (Israel) Ltd. 5, Shacham Street Cesarea North Industrial Park PO Box 3069 CESAREA ISRAEL Tel: Fax: Tyco Healthcare Birchwood Court Montrose Road P.O. Box 8108 Halfway House 1685 MIDRAND SOUTH AFRICA Tel: +27 (0) Fax: +27 (0) Tyco Healthcare Norden AB Gårdsvãgen 18 SE SOLNA SWEDEN Tel: +46 (0) Fax: +46 (0) Tyco Healthcare Belgium N.V.-S.A. Generaal de Wittelaan 9/5 B-2800 MECHELEN BELGIUM Auto Suture Surgical instruments Lusinovkay str., MOSCOW Tel: +32 (0) RUSSIA Fax: +32 (0) tycohealthcare.belgium@tycohealth.com 10/2002

3 VersaStep* System The Next Generation for Surgical Access Pioneers in Surgical Innovation...

VersaStep* System when compared to conventional cutting trocars: Decreased incidence of major vascular injury 1 Decreased incidence of bowel/bladder injury 2 Decreased incidence of abdominal wall

4 2.1mm VersaStep* Needle/Sleeve 9.3mm Dilating Tip Trocar 12mm 11.4mm VersaStep* has reduced significant complications that can occur in laparoscopic surgery Multiple studies have substantiated that the following improved outcomes have been obtained using the VersaStep* System when compared to conventional cutting trocars: Decreased incidence of major vascular injury 1 Decreased incidence of bowel/bladder injury 2 Decreased incidence of abdominal wall bleeding 3 Decreased incidence of post operative incisional hernia 4 In addition: A substantial number of patients report less pain when VersaStep* entry ports are used 5 VersaStep* is self-anchoring and may reduce the need for fascial closure 6 The use of VersaStep* may reduce procedure time 7 VersaStep* needle/sleeve insertion reduces entry profile Optical Trocar 12mm 12.2mm VersaStep* uses a proprietary radially expanding sleeve with needle to initiate the port entry. Conventional trocars, on the other hand, rely upon a metal or plastic cutting tip to penetrate the abdominal wall. The cutting profile of a conventional trocar can be as large as 12.2mm depending on the size of the port required. With VersaStep*, regardless of the port size, entry is accomplished by dilating a tract established by a needle/sleeve assembly with a cross sectional profile of 2.1mm. Conventional Trocar 1 Rothenburg, Decou, Downey, Lelli, Raschbaum; IPEG Meeting, & 3 Galen, Jacobsen, Weckstein, Kaplan, DeNevi; JAAGL (6) 1: 79-84, & 6 Bhoyrul, Mori, Way; Surg Endosc 10: , Yen, Yim; JAAGL (5) 3, 559, Turner; ESGE Meeting, 1999.

5 VersaSeal* Universal Seal minimizes the potential of tears and leakage The VersaSeal* universal seal provides hands-free exchange of instruments ranging from 4.5mm to 12mm without external converters. The blue seal is extremely durable minimising the potential of tears or leakage during instrument insertion or manipulation.

VersaStep* gridiron incisions leave smaller residual defects Radial dilation separates and

non-overlapping slits that resemble a gridiron incision.

wound left behind by conventional trocars.

6 VersaStep* gridiron incisions leave smaller residual defects Radial dilation separates and stretches the tissue and muscle layers along natural anatomic planes making smaller, slit-like wounds. When the VersaStep* cannula is removed, the defects in each layer contract leaving a series of non-overlapping slits that resemble a gridiron incision. The width of the residual VersaStep* defect is approximately one half the size of the stellate wound left behind by conventional trocars. Based on their own clinical experience, surgeons have chosen not to routinely close fascial wounds from 10mm and 12mm VersaStep* port sites. A 4.7mm slit-like defect is left after removing a 10mm VersaStep* device. A 10mm stellate wound is left after removing a conventional trocar.

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