Middle ear fluid aspirator

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S117000, C604S239000, C604S240000, C604S540000, C604S035000

Reexamination Certificate

active

06258067

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to aspirators, and, in particular, to aspirators for removing fluid from the middle ear.
BACKGROUND OF THE INVENTION
Infections of the middle ear present an ongoing problem to both patients who suffer from them as well as to treating physicians who seek to treat them. To the patient, these infections represent acute pain, discomfort, financial cost and/or possible loss of hearing. To the treating physician, these infections present significant dilemmas. Since middle ear infections have been heretofore difficult to treat with medications, the treating physician had basically two therapeutic alternatives.
The primary care physician may either tap the middle ear or refer the patient to an ear, nose and throat specialist so that a tympanocentesis or insertion of tubes may be employed. In order to the tap the middle ear, the physician has utilized suction or conventional syringes which have several attendant disadvantages. Suction assemblies are often not available and are cumbersome to use. Conventional syringes have required the physician to actuate the syringe by pulling back on the plunger. Further, if the needle of the syringe is straight, as is usually the case, then the syringe interferes with the operator's line of vision. A common danger with pre-existing syringe needles is that there is no guard against the operator accidentally penetrating the tympanic membrane in such a way as to cause damage to the bony structures there within.
Therefore, there is a need for an aspirator with increased control that allows a clear line of sight with the tympanic membrane and includes safety features which prevents damage to the ear canal and middle ear structures.
SUMMARY OF THE INVENTION
In view of the foregoing, a present invention is a middle ear fluid aspirator comprising a syringe assembly and needle. The syringe assembly operates via negative pressure in order to provide suction through the needle when the syringe handle is pushed. The needle has an angled or curved region, which permits the operator to use the aspirator while having visual contact with the tympanic membrane. The needle has a fibrillar sheath that shields the sharp tip of the needle to prevent injury while entering the ear canal and retracts upon contact with the tympanic membrane. The sheath may also act as a carrier for anesthetic. A stop is also positioned on the needle to restrict movement of the sheath, thereby helping to limit penetration of the needle. The tip of the needle preferably has a shallow bevel to prevent lateral contact with the medial wall of the middle ear. Preferably, the needle has thin walls that deform when it contacts bone.
A syringe assembly that is actuated by pushing on the handle is a major advantage of present invention. With a physician being able to push the syringe handle rather than pull, the aspirator can be operated with a single hand with greater control with a single hand since the muscles that control the hand can squeeze the thumb toward the rest of the hand more easily than pull it away from the hand.
An important advantage of the present invention is ability to have a clear line of sight with the tympanic membrane. In accordance with this advantage, the needle has a curved portion so that the syringe handle does not obstruct the view of the tip of the syringe. Moreover, the amount of suction delivered to the needle tip is proportional with the rate at which the plunger is pressed.
A major feature of the present invention is the sheath that shields the needle tip until contact with the tympanic membrane. The sheath creates a safety advantage by preventing injury to the ear canal when introducing the needle into the ear. A secondary feature of the sheath is its use as a carrier for anesthetic, or other fluid to be applied to the tympanic membrane. As a result of the carrier function, the fluid can be applied to the tympanic membrane in one step, without the need to introduce another instrument into the ear. Moreover, the sheath acts as a seal around the puncture site while permitting the withdrawal of fluid through the needle to prevent aspiration of air from the ear canal instead of fluid from the middle ear.
An important feature of the present invention is a stop that acts in conjunction with the sheath to limit penetration of the needle. As a result, the physician can be assured that the needle will be prevented from penetrating too far and damaging middle ear structures.
The shallow bevel of the needle tip is another feature of the present invention. Since the middle ear is a shallow structure, the shallow bevel allows sufficient penetration of the needle to allow aspiration of fluid while preventing aspiration of air from the ear canal.
Other features and advantages of the present invention will be apparent to those skilled in the art from a careful reading of the Detailed Description of a Preferred Embodiment presented below and accompanied by the drawings.


REFERENCES:
patent: 3055361 (1962-09-01), Ballard
patent: 3662754 (1972-05-01), Halloran
patent: 4891332 (1990-01-01), Bloem et al.
patent: 5032111 (1991-07-01), Morris et al.
patent: 5167622 (1992-12-01), Muto
patent: 5188617 (1993-02-01), Linder
patent: 5201718 (1993-04-01), Whisson
patent: 5263942 (1993-11-01), Smedley et al.
patent: 5405321 (1995-04-01), Reeves
patent: 5792099 (1998-08-01), DeCamp et al.
patent: 5817075 (1998-10-01), Giungo
patent: 5865814 (1999-02-01), Tuch

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