Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
1999-12-28
2002-08-20
Gilbert, Samuel G. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
Reexamination Certificate
active
06436028
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a bio-magnetic drive system, kit and method for moving a constituent in a human body. In a particular application, the invention relates to a hearing assist system, device and method, but a number of other applications are disclosed to exemplify the invention further. The present invention also relates to a method of connecting magnetically responsive microbeads to a constituent in a human body.
Constituents of a human body sometimes need to be moved in vivo by a force generated other than by the body itself. The constituents can be any mobile part of the body. Non-limiting examples include soft or hard body tissue, such as skin, muscle, vessels, organs, bones, connective matter, nerves, and brain mass. The movement can be with regard to achieving any desired function. Non-limiting examples include the following.
The ossicles of the middle ear are normally moved by changes in air pressure on the surface of the tympanic membrane, in the normal hearing transduction mechanism. The tympanic membrane is connected to the malleus which is connected to the incus which is connected to the stapes in the middle ear ossicular chain. When displacement of these is conveyed to the inner ear (cochlea), then the transduction is made by sensors which convert into nerve action potentials to the hearing centers of the brain. Amplification of hearing would be attained if such movements of an ossicle were amplified. In a damaged middle ear, normal ossiclar displacement or transmission does not occur and some artificial movement technique may need to be used.
The larynx as part of the vocal mechanism contains vocal folds that normally are held in apposition and with tension such that passage of air over the vocal folds produces vibration and the generation of sounds which are shaped as speech by the oral cavity. Such holding of vocal folds in apposition sometimes fails with disease and a mechanism to appose the folds would be beneficial in preserving speech. One prior mechanism includes a piece of silicone rubber surgically implanted next to the paralyzed vocal fold to wedge the vocal cords in apposition.
The eyelid must close to cleanse and protect the surface of the eye (cornea) thousands of times each day. People with motor disease or neurologic problems often have difficulty closing their eyelids and eyes become prone to infection and vision is impaired.
Wound closure for delicate plastic surgical applications is often accomplished with small sutures that require removal and often leave their own scars. If the tissue at the wound could be moved and held together without suturing, no suture scars would occur and no secondary visit to a surgeon for removal of the sutures would be needed. Preferably such closures would be more complete, providing a better barrier against infection and scarring due to infection.
In surgical applications, a surgeon may want tissue to remain in one location (for example, during the healing process, toward the natural anatomical position of the respective body part). In middle ear surgery to reconstruct the middle ear by prostheses or tissue, often large blocks of connective tissue or gelatin foam are used to form a cast to position and hold a prosthesis or operated or freed ossicle in place. This technique requires months of healing for tissue and/or gelatin foam-blood clots to be removed, so another technique for moving and holding the tissue is desirable.
The closure of sphincters in the body can fail. For example, the lower esophageal sphincter when inadequately closed allows acid reflux from the stomach and this can cause damage to the esophagus and lung (aspiration of acid). As another example, the sphincter for closure of the bladder so as to retain urine sometimes requires surgery that includes repositioning and twisting of the stomach and suturing of the lower esophageal sphincter. An improved technique for operating the sphincter could improve lives by minimizing invasive surgery.
Another sphincter application pertains to incontinence following prostate surgery. Patients can be left incontinent because of incomplete closure of the sphincter associated with the prostate. Incontinence may be the result of loss of urinary bladder control. There is the need for improved means and method for enabling closure of body openings.
Another closure application is in erectile dysfunction (ED). This is a circulatory problem where venous engorgement is required for penile erection. Presently such venous engorgement (dilation of veins and filling with blood) is accomplished by a vasodilator such as Viagra. A more cost-effective and non-pharmacological means for increasing engorgement is desirable. A means for increasing venous resistance would cause venous engorgement upstream, resulting in penile erection with the potential-elimination of impotence.
Very delicate nerve surgery where two ends of a severed nerve are sewn together is tedious, long and difficult. The sheath covering the nerve must also be restored for the nerve to live and grow. It is desirable to have some way to manipulate the severed nerve and/or its myelin sheath to cause it to be reapposed without the added insult of needle punctures and sutures adversely affecting the healing process.
Another application of the .present invention is for opening (or closing) of channels or pores or blood vessels. Such openings are important in the circulation of the body as this is the means of getting nutrients, gases and fluids to the tissues. The opening of blood vessels is accomplished normally by a pressure from within, by shear hydrostatic pressures. This does not, however, always occur. For example, if an atherosclerotic plaque is partially occluding someone's carotid artery and impedes blood flow to the head and brain, this vessel needs to be opened immediately or stroke or brain damage could occur. Atherectomy is a lengthy and dangerous procedure to remove the plaque. If, however, the lumen of the vessel could be opened easily and a person treated with lipid reducing medication, surgery on the neck could possibly be avoided and a life saved.
Although any of the foregoing, and others, could be used, assisting human hearing and moving parts of the human hearing mechanism will be used as the specific context for further describing the background of the invention and the preferred embodiments of the invention itself.
There are many different reasons why some people have hearing impairment. In general, however, sound entering the outer ear canal does not get adequately transmitted to the inner ear and/or transduced, then sent by auditory nerve. In some instances, this can be solved by amplifying the sound with a hearing aid put into the outer ear canal. In other cases, a device that electrically stimulates the auditory nerve directly needs to be implanted in the cochlea (the inner ear). In still other situations, a middle ear device that creates mechanical vibrations is needed. There have been disclosures of such middle ear devices, including magnetic, electromagnetic and piezoelectric types. A particular implementation of the present invention pertains to such middle ear actuation, and specifically magnetic and electromagnetic middle ear devices.
A person's normal middle ear includes a chain of three small bones, or ossicles. The malleus, the incus, and the stapes form this chain; and when functioning normally, these ossicles transmit mechanical vibrations from the eardrum, or tympanic membrane, at the end of the outer ear canal to the oval window, the entrance into the inner ear. When something is wrong in this ossicular chain, however, such transmission does not occur sufficiently to stimulate the cochlea and, therefore, auditory nerve. Another type of transmission deficiency occurs in sensorineural hearing loss, where some of the hair cells of the inner ear are not functioning.
One general solution to hearing problems caused by middle ear deficiencies and/or sensorineural hearing loss is to implant a magnet in the middle ear and to cause the magnet to
Gilbert Samuel G.
McAfee & Taft
Soundtec, Inc.
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