Education and demonstration – Anatomy – physiology – therapeutic treatment – or surgery... – Anatomical representation
Reexamination Certificate
2000-01-14
2001-06-05
Rimell, Sam (Department: 3712)
Education and demonstration
Anatomy, physiology, therapeutic treatment, or surgery...
Anatomical representation
C434S262000, C434S365000, C434S433000
Reexamination Certificate
active
06241526
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the medical training devices and particularly to a device preferably used for training physicians in the medical procedure of tympanocentesis for treating certain child ear infections.
2. Description of the Prior Art
Currently physicians are looking for alternative ways for diagnosing and/or treating children effected with an otitiscausing organism, in addition to prescribing an antibiotic. One alternative method is to tap the child's eardrum with a needle at the physician's office for both diagnosis and therapeutic purposes. This tapping method is referred to as tympanocentesis. However, great skill and precision is required to properly perform tympanocentesis. If the needle is not inserted within a relatively small area of the eardrum there is the chance of injury to the child. As most physicians have not included tympanocentesis as part in their daily practice, many fail to possess the skill and precision to properly perform the procedure in their office on a practically error free basis. As such, physicians/pediatricians need to be trained in the procedure prior to incorporating such procedure in their practices. Currently, no practice or training devices exist, which provide realistic conditions, for the physician/pediatrician to obtain proper training.
Tympanocentesis is a surgical procedure characterized by inserting a needle through the tympanic membrane (ear drum) followed by removal of fluid (usually pus). Access to the tympanic membrane is gained through the external auditory canal (ear canal). Visualization of the tympanic membrane through the ear canal requires adequate illumination and magnification for identification of anatomical landmarks prior to insertion of the needle, tympanocentesis is a term often used synonymously with myringotomy. The difference between the two procedures relates to whether a whole is left upon withdrawal of he needle (a tympanocentesis procedure) or a small cut is made in the ear drum after withdrawal of the tympanocentesis needle (a myringotomy).
Tympanocentesis/myringotomy has been a procedure practiced for over a millennia by physicians. In the pre-antibiotic era, it was commonplace for physicians to lance the ear drum in order to relieve the pressure of an acute inflammation of the middle ear space. This provided instantaneous pain relief, drainage of the pus and generally hastened a resolution of the infection. With the advent of antibiotics and their increased availability, the tympanocentesis/myringotomy procedure was used less frequently, particularly as broad spectrum antibiotics became available. Today tympanocentesis is most frequently undertaken by otolaryngologists, although an increasing number of primary care physicians (pediatricians, family physicians and general medicine internists) are finding tympanocentesis a useful diagnostic and therapeutic adjunct in the management of acute otitis media (middle ear infections).
The purpose of tympanocentesis is multifold: (1) immediate relief of pain from a bulging tympanic membrane under pressure from middle ear inflammation; infection induced by predominantly bacterial pathogens; (2) withdrawal of infected middle ear fluid allows for precise identification of the causative pathogens thereby allowing directed antibiotic therapy; (3) withdrawal of the infected fluid enhances the opportunity for an effective immune response since a substantial burden of the microbial pathogens is removed through suction of the infected material; (4) elimination of the hydrostatic force of the infectious process allows for improved ingress of host immune factors (antibodies, etc.) and allows better ingress of antibiotic therapies; (5) removal of the infected pus material also allows more rapid resolution of the inflammatory process including the thickening of middle ear mucosa, over production by mucus cells and ongoing inflammation of the eustachian tube (which normally functions to allow equilibration of ambient air with the middle ear space).
All tympanocentesis devices have in common the insertion of a needle through the tympanic membrane with access via the auditory canal. Sources of illumination and magnification vary. Needle devices vary. In all cases, the tympanocentesis needle is inserted through the tympanic membrane and then suction applied to remove a portion of the infected middle ear fluid. What is needed is a device for improving the safety of the tympanocentesis procedure for the patient. Currently, the procedure has (1) no device which optimizes stabilization of the needle, (2) provides a guide for appropriate insertion location for the needle or (3) provides the operator with an indicator of when the tympanocentesis needle has been inserted to a proper depth through the ear drum to insure adequate suction but not over penetration whereby middle ear bone or mucosa might be inadvertently traumatized.
It is therefore, to the effective resolution of the shortcomings of the prior art that the present invention is directed.
SUMMARY OF THE INVENTION
The present invention provides a device used for training hysicians in the medical procedure of tympanocentesis for treating certain child ear infections. An outer member of the training device preferably resembles a side profile of a small child's head and shoulder area, though such is not limiting. The outer member is preferably attached to a surface portion to define a receiving area for receiving a slidable inner member. A replica of at least an eardrum and ear canal of a child's inner ear is associated with the sliding inner member. Sliding inner member includes a transporting locking member, an “in use” locking member, and a training member.
The transporting locking member prevents any significant movement of the slidable inner member with respect to the outer member. The “in use” locking allows the inner member to travel a necessary distance to properly use the training device, but prevents the inner member from becoming separated from the outer member which could damage the inner member. The training member supports a simulated inner ear, positions the simulated inner ear to a desired position adjacent the outer ear of the outer member, and acts as a holder for the training cartridges used with the training device.
The training cartridges act as changeable tympanic membrane inserts to simulate the “look and feel” of popping through the tympanic membrane. Each cartridge includes a top member and a bottom member. The cartridges include one or more training areas. Preferably, two separate or distinct training materials (particularly in color) are disposed and maintained within each training area of the top member. The first training material represents the safest area for performing tympanocentesis, and is the desired area for puncture by a needle of a syringe by the trainer or user. The second training material represents an undesired area for puncture by the needle by the trainer or user. A third training material can be disposed within the training areas of the bottom member of the cartridge. Preferably, the third training material is separate or distinct from the first and second training materials (particularly in color). The third training material represents that a trainer in tympanocentesis procedures has inserted his or her needle too deep. The training areas of the top member of the cartridge are preferably aligned with corresponded training areas of the bottom member of the training cartridge. Air bubbles can also be injected into one or more of the training materials to more simulate a typical ear infection.
When using the present invention, to achieve optimal training, it is preferred that the training area of the present invention resemble or simulate at least an average child's inner ear in both shape, location and texture (feel). In this regard, the simulated inner ear and the training areas of the cartridges, are preferably constructed from materials to resemble an inner ear's texture. Also to
Auran Mitchell
Pichichero Michael
Stull Steven
Malin Haley & DiMaggio, P.A.
Miller Bena B.
Outcomes Management Educational Workshops, Inc.
Rimell Sam
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