Everting device and method for tracheostomy

Abstract

An integrated device and improved method for tracheostomy which includes the placement of an everted film sheath into a patent's trachea, through which the tracheal tube is inserted.

Description

BACKGROUND OF THE INVENTION[0001]The invention relates to an improved method and related devices for percutaneous placement of airway tubes into the tracheas of living bodies, a procedure known as a tracheostomy, and subsequent supportive maintenance tracheostomy.[0002]Trachesotomies are the most common surgical procedure performed on critically ill patients. The procedure involves multiple steps to create and dilate a stoma and insert a tracheostomy tube, each additional step creating the possibility for error. Standard dilators, such as the BLUE RHINO manufactured by Cook Critical Care, and serial dilators, are inserted with a substantial, axially-inward force to dilate the patient's tissue, which, in addition to requiring significant physical strength on the part of the surgeon, may result in surgery-related complications such as bleeding; perforation of the adjacent vasculature, esophagus, and thyroid; pneumothorax and pneumomediastinum; subcutaneous and mediastinal emphysema; c...

AI Technical Summary

Benefits of technology

[0008]The present invention utilizes everting technology, in combination with novel means for placement and maintenance of airway tubes, to simplify tracheostomy, reduce trauma to the intervening and adjacent tissue and minimize the potential for microbial infection. While it is anticipated that the invention would be used for tracheostomy, the claimed device could also be used for cricothyrotomy.

[0009]Everting is the laying down of a thin-walled “film” sheath along the tissue entrance path wall during advancement of a placement device, somewhat like tank treads being laid down along the ground. The film sheath is pre-loaded inside a placement device and as the film sheath emerges it everts, with the inside of the film sheath becoming the outside. The extremely thin-walled film sheath is made of a biomaterial that is lubricious, strong, flexible, and resilient. Use of such an everting film sheath virtually eliminates the drag, shear force, and friction generally associated with placement, maintenance and removal of standard tracheostomy devices, minimizing trauma and the potential for microbial infection. The chance of infection is further reduced by appropriate selection of biomaterial to reduce or eliminate biofilm buildup.

Problems solved by technology

The procedure involves multiple steps to create and dilate a stoma and insert a tracheostomy tube, each additional step creating the possibility for error.

Standard dilators, such as the BLUE RHINO manufactured by Cook Critical Care, and serial dilators, are inserted with a substantial, axially-inward force to dilate the patient's tissue, which, in addition to requiring significant physical strength on the part of the surgeon, may result in surgery-related complications such as bleeding; perforation of the adjacent vasculature, esophagus, and thyroid; pneumothorax and pneumomediastinum; subcutaneous and mediastinal emphysema; cartilage fractures; and suprastomal collapse.

Further, dilatators drag against the patient's tissue with a shear force and considerable friction, causing tissue trauma resulting in pain, slow healing, as well as, potentially, dysphagia, extensive scarring and disfiguration.

Finally, insertion of a dilator may cause infection as a result of dragging or “tracking” microbes into the trachea from the skin of the entry site or from subcutaneous layers.

After the patient's tissues are dilated, insertion of a standard tracheostomy tube, such as the SHILEY manufactured by Covidien, creates a similar shear force and friction, with the same potential for complications, as the insertion of a dilator.

Additionally, while in use, the tracheostomy tube can create additional complications such as tissue erosion, fibrotic, scar and granulation tissue formation and necrosis, which can result in tracheal stenosis necessitating surgical repair.

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