Methods and devices for soft palate tissue elevation procedures

Abstract

A self-retaining suture having particular application for treating obstructive sleep apnea and use thereof. The suture includes rising an elongated suture body having a periphery and first and second tissue-penetrating ends each with a bi-curve needle, and a plurality of first retainers on a first segment and oriented to the first end, and a plurality of second retainers a second segment and oriented to the second end, and a retainer-free transition segment disposed between the pluralities of first and second retainers.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Appln. Ser. No. 61 / 493,941 filed on Jun. 6, 2011.FIELD OF THE INVENTION[0002]The present invention relates generally to self-retaining sutures and methods for using self-retaining sutures in soft palate elevation procedures.BACKGROUND OF THE INVENTION[0003]Wound closure devices such as sutures, staples and tacks have been widely used in superficial and deep surgical procedures in humans and animals for closing wounds, repairing traumatic injuries or defects, joining tissues together (bringing severed tissues into approximation, closing an anatomical space, affixing single or multiple tissue layers together, creating an anastomosis between two hollow / luminal structures, adjoining tissues, attaching or reattaching tissues to their proper anatomical location), attaching foreign elements to tissues (affixing medical implants, devices, prostheses and other functional or supportive devices...

AI Technical Summary

Benefits of technology

[0011]It is desirable to provide bidirectional self-retaining sutures having configurations particularly suited to soft palate elevation procedures. Thus, it is desirable to provide improved self-retaining sutures having enhanced clinical performance in soft palate elevation.

Problems solved by technology

Knot tying takes time and causes a range of complications, including, but not limited to (i) spitting, a condition where the suture, usually a knot, pushes through the skin after a subcutaneous closure), (ii) infection (bacteria are often able to attach and grow in the spaces created by a knot), (iii) bulk / mass (a significant amount of suture material left in a wound is the portion that comprises the knot), (iv) slippage (knots can slip or come untied), and (v) irritation (knots serve as a bulk “foreign body” in a wound).

Suture loops associated with knot tying may lead to ischemia (knots can create tension points that can strangulate tissue and limit blood flow to the region) and increased risk of dehiscence or rupture at the surgical wound.

Knot tying is also labor intensive and can comprise a significant percentage of the time spent closing a surgical wound.

Additional operative procedure time is not only bad for the patient (complication rates rise with time spent under anesthesia), but it also adds to the overall cost of the operation (many surgical procedures are estimated to cost between $15 and $30 per minute of operating time).

These include wearing of devices such as face masks providing continuous positive airway pressure and mandibular advancement devices; however, such treatments necessarily rely on ongoing

Reduction of uvula volume can result in adverse effects such as occlusion of the airway by the base of the tongue and restriction of the velopharynx and oropharynx due to postoperative scarring, both of which can contribute to an increase in sleep apnea.

), and can have adverse effects such as extrusion of the implant and associated effects (including infection, further surgical procedures for removal of the implant, etc.).

These procedures can result

As this procedure is performed with two unidirectional sutures, there is some risk of suture extrusion unless the trailing ends of each suture are somehow anchored (by, for example, knot-tying), and such anchoring can itself provide a nidus for infection, etc, while any exposed suture remaining in the oral cavity can create issues with healing and infection.

Moreover, the procedure can cause bunching of soft palate tissue.

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