Solution 1

Levalap™ 1.0

Laparoscopic Surgery Access Device for Veress Needle Introduction

Single Use, Disposable Device

Challenge 1

Laparoscopic Surgery Access through Veress Needle

Mostly GYN Procedures

Blind access

  • Spring loaded needle tip
  • Operator “feels” the needle enter the safe zone

Multi-operator

GYN/Surgeon and nurse must participate

GYNECOLOGY:

Laparoscopic Surgery Access, Complications Risk Analysis

Laparoscopic complications due to access

40% to 75% of laparoscopic complications occur during the primary port placement, incl. Veress needle insertion 4-5

50% of all laparoscopic bowel and vascular injuries occur at the time of entry 3

An incorrect insertion of the Veress needle into a vein, during insufflation, can result in fatal massive gas embolism 6

In low catastrophic incidences, mortality ranges between 8%-17% 7

Published initial access complications rate (in <1% of patients 8) is believed to be underestimated by many 9-10-11-12

This incidence does not account for novice surgeons experiences, undetected injuries/ unreported complications appearing in ER, adhesions risk, low BMI, and multiple ”sticks” complications

Up to more than 85% after the 3rd attempt

Postsurgical adhesions occur in 70-95% of patients undergoing major gynecologic surgery

Increased access risk in patients with adhesions

Increased access risk with patients of low BMI to do anatomical predisposition

Multiple “sticks” increase complication risks

Residents, Fellows, Novice LAP GYNs

In 8% of laparoscopies, surgeons perform two or more access attempts with the Veress 9

Complications risk increases up to 16-37% on the 2nd attempt 13-14

Complications risk increases up up to the 44-64% on the 3rd attempt 9-10

Complications risk increases up up to more than 85% after the 3rd attempt 9-10

Postsurgical adhesions occur in 70–95% of patients undergoing major gynecologic surgery

Increased access risk in patients with adhesions 12

Increased access risk with patients of low BMI to do anatomical predisposition 12

GYNECOLOGY:

Laparoscopic Surgery Access – Takeaway

Laparoscopy access complications are a real problem

“[…] Many authors have expressed the degree of perplexity above the reliability of these (published low complications) figures and consider the incidence of major vessel injury (MVI) to be underestimated as it might be grossly under-reported”. 12

An effective solution is needed

Still, the incidence over so many years has remained unchanged, irrespective of all innovations to make laparoscopic entry safer, and these have found no correlations with the severity of procedures. 12

Lap access risk mitigation needs to be standardized for all operators, novice and experts alike

“[…] the sudden catastrophic episode could be unnerving for all present in the theater. Such episodes have long-term legal implications which may be sorted out, but their mental imprint can scar a novice surgeon for life”. 12

GYNECOLOGY:

Laparoscopic Surgery Abdominal Access Points

Abdominal access points

Confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall can be circumvented by using other abdominal access points, non-peri umbilical.

Alternative abdominal entry points are:

Palmer's point

The universally preferred point of entry for peritoneal access in women having undergone earlier abdominal surgeries 11. Lies 3 cm below the left subcostal margin in the mid-clavicular line. Helps to avoid adhesions. Lifting the skin is manual and requires 2 operators.

Lee-Huang point

the less common being: midline supraumbilical region

Jain point

lateral to the umbilicus

ASIS

the superior anterior iliac spine landmark

LevaLap™ 1.0

Laparoscopic Surgery Access Device for Veress needle Introduction

Single Use, Disposable Device

How it works
  • LevaLap™ is a sterile external device, clear curve-shaped, with a vacuum port and an injection septum
  • The port connects to a standard OR vacuum system
  • After placing LevaLap™ on the patient’s abdomen, vacuum is applied through the vacuum port
  • Negative pressure is introduced onto the surface of the patient’s abdomen lifting the abdominal wall into the curve and creating an additional safe peritoneal space to protect underlying abdominal organs and vessels
  • The injection septum at the top of the LevaLap™ enables insertion of a Veress needle or similar device into the initial additional peritoneal safe space while maintaining negative pressure on the abdominal wall
  • The negative pressure ensures a rapid and smooth gas filling
  • After gas filling, the Veress needle is retracted, suction released and LevaLap™ device withdrawn, leaving the abdominal region ready for surgery.
1. LevaLap™ 1.0 placed on abdomen
2. Standard OR suction applied to port to lift the abdominal wall
3. Veress needle inserted for pneumoperitoneum creation
4. Needle retracted – Suction released – LevaLap™ 1.0 removed

Main Technical Features

LevaLap™ Addresses the Current Challenges in GYN/Veress Needle Access Laparoscopic Surgery:

Patented injection septum

Facilitates Veress Needle puncture

No “pop through” of injection site during needle insertion

Absorbs and distributes Veress needle pressure

Snap ring of septum provides complete seal and security

Patented angulated septum allows 150 degree angulation of Veress needle

K-Resin biocompatible and thermoplastic copolymer provides greater transparency, visibility and radiation sterilization compatibility

Fully injection-molded device enhances quality and durability: no adhesives used

Strong yet light

The septum memory material allows vacuum retention upon puncture with a Veress needle

Material allows complete visualization of the area under the hemisphere during the procedure

Patient interface is atraumatic and designed to adapt to the various human anatomies

Hemispheric design with dual holding points and vertical vacuum provides excellent ergonomics to facilitate handling during use

Compatible with commonly used surgical preparation antiseptics

Fully disposable and recyclable

Clinical Benefits

LevaLap™ 1.0 Addresses the Current Challenges in GYN/Veress Needle Laparoscopic Surgery Access, as it Aims to Standardize by:

  • Facilitating a safer and more successful access
  • Facilitating access at the 1st attempt
  • Eliminating the need of a 2nd operator during surgery access
  • Allowing rapid access time
  • Increasing patient safety

Initial access aim: control, precision, safety and speed standardized across operators

Setting the standard for laparoscopic access