A new slim profile laparoscopic device – Comparing traditional laparoscopic instruments and available slim profile device using FLS testing protocols.

Lars Webb, MD, Nova Szoka, MD, Richard Miskimins, MD, Edward Auyang, MD, MS, FACS. University of New Mexico School of Medicine

Objective of the Device:

The Miret™ slim profile laparoscopic instruments are low profile laparoscopic instruments with 5mm working tips which will allow for smaller incisions of the skin and fascia while maintaining the standard tip size.

Description of device and device usage:

The Miret slim profile laparoscopic instruments have a 2.4mm profile shaft with a 5mm working tip. Intra-corporeal assembly of the instruments allows less disruption of the skin and fascia during laparoscopic procedures. The intracorporeal assembly of the instrument allows for a 5mm working tip, a traditional size which allows for an effective actuating tip. Assembly is performed intra-corporeally with a proprietary device through a 10mm port. Internally, they function as traditional instruments with the ability to change the tips allowing for a wide range of different of instrument tips to be deployed.

Preliminary Results:

Using the peg transfer task of the FLS testing protocols,the new low profile laparoscopic instruments were compared against the traditional laparoscopic instruments and a currently available slim profile laparoscopic tool, (Mini-Lap™). The average time for all users was 88.3 sec for standard laparoscopic instruments, while Miret instruments took statistically longer with an average of 109.8 sec (p = 0.022). Minilap instruments also took a statistically longer time with an average of 205.4 sec (p <0.0001). Comparing Miret to Mini-lap, Miret was statistically faster (p <0.0001).

Analysis was undertaken comparing advanced (PGY3 and higher) versus novice (PGY2 and below) laparoscopists’ time performing the task. Advanced users were faster with standard instruments with an average time of 61.7 secs compared to 86.5 secs for Miret (p = 0.0054). Novice users were also faster with standard instruments ( 108.9 sec) compared to Miret instruments (127.8 sec) though this was not statistically significant (p= 0.3524).

Times to assemble and dissemble the Miret instrument were also tabulated. Timing was begun before the tools were introduced into the Lap trainer box. Average times to assemble and disassemble the device were small. The average time taken to assemble the instrument by all users was 23.5 sec with a standard deviation of 18.6 sec. Disassembly took 14.6 sec with a standard deviation 10.9 sec.

Conclusions/Future study plans:

The assembly of the Miret instrument intra-corporeally added minimal time to task completion. Completion of the FLS peg transfer task was slower with Miret when compared to traditional laparoscopic tools for advanced users and as a whole. These differences in performance were paralleled with the advanced group, however, not difference was seen with novice users. This suggests that there is a role played by familiarity with the standard instruments. All groups were quicker, however, when using Miret laparoscopic tools when compared to the current Mini-lap instruments.

The next steps in the assessment of this new device will be use in human clinical trials with the Miret instrument to determine practical efficacy and feasibility.

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