Surgery – Surgically implanted vibratory hearing aid
Reexamination Certificate
1999-12-21
2002-05-21
Winakur, Eric F. (Department: 3736)
Surgery
Surgically implanted vibratory hearing aid
C128S899000
Reexamination Certificate
active
06390970
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to the field of permanently implantable devices for intraoperative positioning and subsequent fixing of active or passive implantable actuator or sensor in a human body, especially in the mastoid and middle ear area of the skull.
2. Description of the Related Art
In view of the extraordinarily small and sensitive anatomic structures in the human body, especially in the mastoid and middle ear area of the skull, it is almost impossible to hold an actuator or a sensor in position by hand for longer than a few seconds and to do so would require a considerable expenditure of strength and concentration by the surgeon. However, many surgical procedures in the body, especially in the skull area, requires targeted positioning of suitable actuator or sensor over long time intervals.
As a result, hand-guiding of actuator and sensor during microsurgical, therapeutic or diagnostic manipulations of such small sensitive structures, for example of the skull, always entail the risk that as a result of the possible relative movements between the hand-guided means and the body of the patient, these target structures are damaged or changed under certain circumstances. Thus, in such medical techniques, there has long been a need for a positioning and fixing system which can be anchored stationary on the body, especially on the skull, by means of a holding device.
Various implantable actuator holding devices are known from the prior art. A holding device, as a component of a partially implantable piezoelectric hearing aid for stimulating the stirrup, was presented by N. Yanigihara, K. Gyo and Y. Hinohira in the article Partially Implantable Hearing Aid Using Piezoelectric Ceramic Ossicular Vibrator which appeared in Otolaryngologic Clinics of North America, Vol. 28, No. 1, February 1995, pages 85-97. The external part of the device is made like a conventional, behind-the-ear hearing aid and contains a microphone, amplifier, battery and the external transmitting coil. The internal part of the device which is fixed on the skull, is used to hold the inner receiving coil. For positioning and fixing of the piezoelectric bimorph converter in the middle ear, there is a relatively simple L-shaped, bone-anchored fastening element. The fastening element is a retaining sheet which can be fixed on the skull cap with two bone screws and is composed of a metal plate with two elongated holes and a wire axle attached vertically thereto. After the metal plate is screwed onto the skull cap, the wire axle points toward the middle ear (medially). On the wire axle, a sleeve can be axially pushed and thus, the piezoelectric bimorph converter can be positioned by fastening it to the sleeve. This enables one axial and one rotational degree of freedom on the wire axle. After disintegrating the hammer and the anvil, the free end of the piezoelement can be fastened preferably directly on the stirrup head with cyanoacrylate cement.
Another holding system for an actuator implant module which improves hearing was described by J. Frederickson, J. M. Coticchia and S. Khosla in the article entitled Ongoing Investigations Into Implantable Electromagnetic Hearing Aid for Moderate to Severe Sensorineural Hearing Loss which also appeared in Otolaryngologic Clinics of North America, Vol. 28, No. 1, February 1995, pages 107-119. This holding system is a component of a partially implantable electromagnetic hearing aid which had been tested previously in an animal model. For its implantation, a small hole is made in the anvil body with a surgical laser to attach a permanent magnet. The laser head is guided in this case in a threaded sleeve with an inner and an outer thread which has been screwed into the mastoid bone, the longitudinal axis of the threaded sleeve pointing to the anvil body. After the laser hole is made in the anvil and the laser head is removed, the electromagnetic drive (“transducer probe tip”) can be screwed into this threaded sleeve and positioned medially to the magnet which is attached to the ossicle.
Another holding system was developed by Maniglia et al. for a partially implantable electromagnetic middle ear stimulator as described in Contactless Semi-Implantable Electromagnetic Middle Ear Device for the Treatment of Sensorineural Hearing Loss by A. J. Maniglia, W. H. Ko, M. Rosenbaum, T. Falk, W. I. Zhu, N. W. Frenz, J. Werning, J. Masin, A. Stine and A. Sabri as published in Otolaryngologic Clinics of North America, Vol. 28, No. 1, February 1995, page 121. Here, a small magnet is cemented to the anvil using surgical cement. The drive coil can be positioned along a titanium guide shaft which can be implanted in the mastoid up to an air gap of a maximum 1 mm to the permanent magnet which is attached to the ossicle. This titanium shaft has, like in the device of Yanigahara et al., two elongated holes and an additional drill hole for fixing by means of three bone screws on the skull cap. By means of a threaded axle, an electronic module and the drive coil attached thereto, can be positioned medially in an elongated hole guide and can be fixed via a screw with a lock nut on the shaft.
The above described prior art holding systems are used for permanent fixing of the components of the hearing aid on the skull bone or in the vicinity of the middle ear and inner ear. Overall, they exhibit an extremely limited intraoperative positioning capacity due to the absence of useful degrees of freedom. In addition, they must all be matched to the anatomic circumstance of the implantation site and to the pre-established location of the target point in the middle ear by more or less precisely manually bending. Two of the above described holding systems also require the use of an adhesive or surgical cement to fix a component of the device and are often not suited as long term implants due to losses in adhesion strength.
U.S. Pat. No. 5,788,711 discloses an implantable, fixable positioning system for secure linkage to the human body, especially to the human skull, which can be permanently attached without adhesives or surgical cements or without manually bending the implant holder. This system allows positioning of surgical, therapeutic or diagnostic sensors or actuators in the body free of relative motions, and fixes them securely in the established position. This system is provided with a holding device which can be fixed on the human body, a ball joint attached to the holding device by a clamp mechanism, and be manually positioned using an auxiliary tool. A guide rail is permanently connected to the ball of the ball joint and a threaded spindle is pivotally mounted in the ball and within the guide rail but the spindle cannot move axially. A carriage is guided in the guide rail and on the threaded spindle for an axial adjustment motion. In this regard, the system includes a feed nut which is secured against rotary motion relative to the guide rail and engages the threaded spindle by the threads. The feed nut can be freely positioned by turning the threaded spindle by means of an auxiliary tool along the guide rail. The system also includes a receiver which is attached to the carriage of an implantable device to be positioned or fixed. This positioning and fixing system has proven especially effective in practice in the implantation of hearing aids. However, further improvements are desired with respect to guide accuracy and ease of use.
Therefore, there still exists an unfulfilled need for an improved system which can be permanently attached to the human body free of relative movements and to fix implantable device in the ascertained position more accurately and for such a system which is more easily used.
SUMMARY OF THE INVENTION
The primary objects of the present invention is to provide an improved implantable positioning and fixing system for positioning and fixing of an implantable device relative to a human body which is more accurate and more easily used.
These objects are achieved by providing a permanently implantable positioning and fixing system f
Nixon & Peabody LLP
Phonak AG
Safran David S.
Veniaminov Nikita R.
Winakur Eric F.
LandOfFree
Implantable positioning and fixing system for actuator and... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Implantable positioning and fixing system for actuator and..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Implantable positioning and fixing system for actuator and... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2845835