FIELD OF THE INVENTION

This mechanism is designed for implantable cuffs used in both fields of research and clinical settings. The intended applications of cuffs or a particular study of interest do not relate to this mechanism. Biomedical research, animal studies, clinical applications for treatments at the hospital, or localized pharmacological approach are potential fields to receive benefits of using implantable cuffs with this mechanism. This closure mechanism is incorporated to be part of the implantable cuff to give a better seal along the edges of the cuff, and to stabilize cuffs with locking units to avoid unwanted re-opening of cuffs during implantation and after completion of the surgical procedure.

BACKGROUND OF THE INVENTION

Several implantable cuffs have been used in research and very few are used in clinical settings for treatments. Prior cuffs were designed to enclose the tissue and to close with sutures. There are disadvantages from the use of sutures to close the cuff. For instance, suture material either absorbable or non-absorbable can retain contaminants or serve as a focal point for connective tissue to grow around it. Sutures used for implantation has a lifetime of a few months inside a human body to provide a constant tensile strength. Sutures may be required to close the cuffs for an extended period-of-time to prevent re-opening of the cuffs for the clinical applications. Another disadvantage is when sutures do not close the cuff tightly, connective tissue may grow inside the cuff, and this interferes with the interaction at the interface between the cuff and the enclosed tissue. When sutures close the cuff too tightly, it may lead to inflammation at the enclosed site and increase the chance of cuff implant failure. Furthermore, if sutures can not stabilize the dimension of the cuff, the edges of the cuff may overlap each other resulting in tissue damages inside the cuff.

The above disadvantages associated with prior cuff design can be addressed with the closure mechanism in this patent. This closure mechanism can provide a stable dimension for the cuff, and to ensure a smooth continuous outer surface to prevent tissue growing inwardly to the cuff lumen and to eliminate potential focal points created by using sutures. The cuff body and its closure mechanism are made of biocompatible and durable materials that can last minimum of 10 years inside a human body without significant defect. Although to increase number of closing sutures may improve the efficacy of the implantable cuff, it also increases the opportunities of having tissue growth, contaminations, and complications. This is a potential disadvantage of using cuffs in clinical settings. Decreasing the number of closing sutures may save time and simplify the procedure of implantation, but it increases the chance of cuff opening as sutures break down, and complications or failures associated with cuff opening. Reliable sutures used for implantations are relatively inexpensive to obtain and very cost effective for the end users. However, the cost of removing cuffs, procedure failures, risk of sutures break down, complications, recovery, re-evaluation, and re-implantation are fairly expensive to the health care system, insurance companies and end users. The described closure mechanism in this patent is easy to use, non-technique sensitive, not required of specialized skills, and time saving compared to using sutures.

It has been difficult to use cuffs for implantation. It requires specialized tools and surgical procedures may be challenging. To implant around a nerve or tissue of a particular locations may also be risky using a cuff. Many clinicians are reluctant to use cuffs for implantation procedures. It is delicate, time consuming, and skills required to clean out surrounding tissue and to isolate the tissue of interest. There is no simple method to open and orient the cuff during implantation procedures. The body tissue may be compressed or damaged when the cuff is not closed properly or when the surrounding tissue is not cleaned well enough. In case of complication or failures, to remove implanted cuff can be difficult due to connective tissue growth and limited access.

SUMMARY OF THE INVENTION

The cuff having a closure mechanism in this patent can improve the surgical procedure for cuff implantation. This cuff and the integral closure mechanism are shown inFIG. 1. The cuff can be opened with fingers and passed around the tissue with ease. After property enclosing the body tissue, the cuff can be closed and locked with finger pressure. When the cuff is closed, the closure mechanism seals the edges of the cuff. When the tissue of interest is not properly oriented for implantation or the surrounding tissue is not retracted well at the surgical site, the cuff will not close. Since the outer surface of the cuff is smooth and continuous when closed, the potential problem of tissue growth is minimized. When implanted cuffs are indicated for removal, the removing procedure is not complicated. The closure mechanism can be released and closed by using fingers. No specialized tools are needed to open and orient the cuff during implantation. This patent introduces the design to reduce chances of cuff implant associated complications and failure.

