Antimicrobial annuloplasty ring having a biodegradable insert

Abstract

This invention provides an antimicrobial annuloplasty rings, and methods for making the same, wherein the annuloplasty rings have a desired degree of initial rigidity to facilitate ease of handling during implantation but which becomes flexible some time after implantation. The annuloplasty ring contains a relatively rigid insert enclosed by a fabric sheath, the insert being at least partly comprised of a biodegradable material. Following surgical implantation of the annuloplasty ring, the rigid insert component of the ring, upon exposure to blood and/or other physiological fluids, undergoes a controlled biodegradation which decreases its rigidity, thereby increasing the flexibility of the implanted annuloplasty ring. Furthermore, at least some portion of the annuloplasty ring of the invention has incorporated therein one or more antimicrobial agents in a manner which reduces the likelihood of device infection following implantation.

Description

[0001] This invention relates generally to devices for use in the surgical repair of heart pathologies, and, more particularly, to antimicrobial annuloplasty rings which contain relatively rigid biodegradable inserts.DESCRIPTION OF THE RELATED ART[0002] Human heart valves can become deformed or otherwise damaged by any of a number of processes brought on by normal aging and / or disease pathologies. For example, degenerative diseases can cause the valve annulus to become enlarged to the point where the leaflets attached to it cannot fully close. This situation, known as valve incompetence, eventually requires surgical correction by valve repair or replacement procedures. Of the surgical options available for valve reconstruction, valvular annuloplasty represents the procedure most frequently performed, particularly for the tricuspid and mitral valves. Valvular annuloplasty is an operation whereby ring-shaped devices or bands, known as annuloplasty rings, are sewn to the distended valv...

AI Technical Summary

Problems solved by technology

Human heart valves can become deformed or otherwise damaged by any of a number of processes brought on by normal aging and / or disease pathologies.

This situation, known as valve incompetence, eventually requires surgical correction by valve repair or replacement procedures.

The wire is somewhat stiff yet resiliently deformable and is not intended to be removable from the cloth covering.

Although a rigid ring's oval shape has been claimed to enhance the competence of the repaired valve, its rigidity can also impede the beneficial flexing movements of the native annulus during the cardiac cycle.

Because of their flexibility, these rings can be difficult to handle during surgical manipulations and generally must be supported during implantation by a holder which is subsequently removed before tying off the implanting sutures.

However, this approach requires undesirable additional handling after the ring is implanted.

Unfortunately, this ring will be difficult and costly to manufacture and will suffer from the drawbacks afflicting both flexible and rigid rings.

Colonization of microorganisms on the surfaces of annuloplasty rings and other implantable medical devices can produce serious and costly complications, including the need to remove and / or replace the implanted device and / or vigorous treatment of secondary infections.

Although infection of implanted medical devices is a relatively infrequent complication associated with their clinical use, the threat to infected patients, and the cost to the medical care system, are significant.

Unfortunately, such approaches have had only limited success.

For example, although coating a material with immobilized antimicrobial compounds has been reported to effectively reduce bacterial colonization of devices in a laboratory setting, similar results have been difficult to replicate in the clinical setting.

Unfortunately, many clinically relevant bacteria produce a slimy protective substance called biofilm within which they grow.

Thus, devices coated with immobilized antimicrobial agents may effectively prevent colonization of planktonic bacteria in the laboratory, but may be completely ineffective in preventing infection of devices by clinically relevant biofilm-enclosed bacteria.

As a result, the experimental use of planktonic bacteria cultured in the laboratory, rather than biofilm bacteria derived from clinical infections, has led to the commercialization of numerous antimicrobial medical devices lacking clinical efficacy.

Therefore, antimicrobial agents immobilized on the surface of a medical device, and therefore not subject to diffusion, have less than optimal activity against many clinically relevant microorganisms.

Unfortunately, the use of these additional components can substantially increase the materials and processing costs associated with such a method, and can also lead to degradation of the antimicrobial agents.

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