A pilot study on a new anchoring mechanism for surgical applications based on mucoadhesives

Abstract

In order to minimize the invasiveness of laparoscopic surgery, different techniques are emerging from research to clinical practice. Whether the incision is performed on the outside – as in Single Port Laparoscopy (SPL) – or on the inside – as in Natural Orifice Transluminal Endoscopic Surgery (NOTES) – of the patient's body, inserting and operating all the instruments from a single access site seems to be the next challenge in surgery. Magnetic guidance has been recently proposed for controlling surgical tools deployed from a single access. However, the exponential drop of magnetic field with distance makes this solution suitable only for the upper side of the abdominal cavity in nonobese patients. In the present paper we introduce a polymeric anchoring mechanism to lock surgical assistive tools inside the gastric cavity, based on the use of mucoadhesive films. Mucoadhesive properties of four formulations, with different chemical components and concentration, are evaluated by using both in vitro and ex vivo test benches on porcine stomach samples. Hydration of mucoadhesive films by contact with the aqueous mucous layer is analyzed by means of in vitro swelling tests, whereas optimal preloading conditions and adhesion performances, in terms of detachment force, supported weight and size are investigated ex vivo. Mucoadhesion is observed with all the four formulations. For a contact area of 113 mm², the maximum normal and shear detachment forces withstood by the adhesive film are 2,6 N and 1 N respectively. These values grow up to 12,14 N and 4,5 N when the contact area increases to 706 mm². Lifetime of the bonding on the inner side of the stomach wall was around two hours. Mucoadhesive anchoring represents a fully biocompatible and safe approach to deploy multiple assistive surgical tools on mucosal tissues by minimizing the number of access ports. This technique has been quantitatively assessed ex vivo for anchoring on the inner wall of the gastric cavity or in gastroscopic surgery. By properly varying the chemical formulation, this approach can be extended to other cavities of the human body.

Key words::

• Mucoadhesive films
• anchoring system
• minimally invasive surgery
• single port laparoscopy
• natural orifices transluminal surgery

Acknowledgment

This material is based in part upon work supported by the European Commission in the framework of ARAKNES FP7 European Project 224565. The authors wish to thank N. Funaro, A. Melani, G. Favati and C. Filippeschi for prototypes manufacturing as well as Dr. Di Sacco for providing freshly excised porcine tissues.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.