Implantable device

Abstract

An implantable device for aiding in generating connective tissue between a pair of anatomical structures in a mammalian body is provided. The device includes an elongate, flexible tether which can be secured between the anatomical structures and which carries a scaffold which is generally porous so as to be capable of promoting tissue ingrowth and collagen deposition along its length. The scaffold extends along the tether for a sufficient distance so that it is securable in at least close proximity to an anatomical structure at either end. The pores in the scaffold extend through the scaffold and each has a diameter in the range of about 10 μm to about 200 μm. The length of the tether is selected to be a desirable maximum distance between the anatomical structures along a desired path when secured therebetween.

Description

FIELD OF THE INVENTION[0001]This invention relates to an implantable device and method for using such a device. One aspect of the invention provides for an implantable device which may be useful in the treatment of conditions relating to sleep apnoea.BACKGROUND TO THE INVENTION[0002]Obstructive sleep apnoea (OSA) is a serious, debilitating condition characterised by blockage of the upper airway during sleep as a result of collapse of the soft tissues in the throat. OSA is associated with significant morbidity and mortality, the impact of which has not as yet been fully defined and assessed in the global community. It is estimated that approximately 2% to 4% of the adult population in Western countries are affected, but these figures may represent a gross under-estimation of the problem. Patients suffering from OSA have sleep fragmentation and deprivation as they are unable to achieve adequate rapid eye movement sleep resulting in a non-refreshing sleep pattern. The major symptom of ...

AI Technical Summary

Benefits of technology

[0039]The invention still further provides a method of treating sleep apnoea which includes securing between the base of the tongue and the chin an elongate, flexible tether carrying an elongate scaffold which is generally porous so as to be capable of promoting tissue ingrowth and collagen deposition along its length, advancing the base of the tongue towards the chin a desired distance using the tether, and permitting a tendon to be formed between the chin and tongue in and on the scaffold.

Problems solved by technology

OSA is associated with significant morbidity and mortality, the impact of which has not as yet been fully defined and assessed in the global community.

It is estimated that approximately 2% to 4% of the adult population in Western countries are affected, but these figures may represent a gross under-estimation of the problem.

Patients suffering from OSA have sleep fragmentation and deprivation as they are unable to achieve adequate rapid eye movement sleep resulting in a non-refreshing sleep pattern.

The major symptom of OSA is excessive daytime sleepiness (EDS).

As a result, lack of concentration and memory, changes in mood and personality as well as an increase in workplace and traffic accidents have been linked to EDS.

Moreover, there are significant comorbidities linked to OSA.

Obesity is considered a major risk factor in the development and progression of OSA.

Compliance of the upper airway is negatively affected by the external pressure of para-pharyngeal fat deposition.

In addition, deposits of fat around the thorax (truncal obesity) can reduce chest compliance and functional residual capacity, thereby increasing oxygen demand.

In view of the above and given the fact that obesity is reaching epidemic proportions, the close association between weight gain and disease progression heightens the concern that OSA, with its attendant plethora of serious comorbidities, as well as attendant complications, will inevitably impose an enormous financial burden upon health care delivery.

During sleep, it is often the case that brief obstructions of airflow and / or small decreases in the amount of airflow into the lungs can occur.

However, CPAP adherence is still difficult.

Besides compliance, the CPAP apparatus presents local problems such as bloating, nasal drying, dry eyes and itchiness of facial skin.

In addition, bed partners are adversely affected.

CPAP is also dependent upon electrical power making it difficult to use while travelling.

Also, the high cost of CPAP delivery makes it a problem in third world countries and the routine use of such devices is difficult to justify.

In addition, 20 events per hour is not always judged an adequate surgical outcome, especially in view of the uncertain correlation between AHI and apnoea complications.

In many cases, snoring will stop after UPPP, but disordered breathing continues, leading to silent apnoea.

Thus, the role of UPPP without tongue base advancement surgery for treatment of OSA is rather limited.

Radiofrequency (RF) treatment of the tongue base produced promising early results but was not consistent in the long term.

Newer surgical approaches, such as laser-assisted palatal procedures and radiofrequency ablation techniques, have also been disappointing.

However, during wakefulness, the suture material acts as a cutting device and migrates anteriorly losing its efficacy within a few months.

Another tongue suspension device known as the Repose™ also has only limited efficacy.

However, the gains appear to be only short term and its long term prognosis as a tongue suspension device is poor.

This device is complex and considered to have the same limitation as those of the AIRvance and Repose™ devices.

However, any scar or connective tissue formed on the coating about the elongate element will at best form a sheath over the elongate element and its movement will of course be limited to that of the elongate element.

Furthermore, the device disclosed in Dineen is mostly non-absorbable and consequently may be more prone to infection which may limit its clinical application.

While tongue advancement offers a useful method of treating OSA, there is currently no practical, long term method of achieving this.

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