Brushing – scrubbing – and general cleaning – Implements
Reexamination Certificate
2001-02-13
2002-11-26
Till, Terrence R. (Department: 1744)
Brushing, scrubbing, and general cleaning
Implements
C015S206000
Reexamination Certificate
active
06484345
ABSTRACT:
TECHNICAL FIELD
This invention relates to a voice prosthesis accessory device and, more particularly this invention relates to an improved brush for cleaning long-dwelling voice prosthesis while installed in a patient.
BACKGROUND OF THE INVENTION
There are several options for restoring speech to patients who have had their larynx removed. One procedure is to surgically create a puncture of fistula between the trachea and the esophagus. A trachea voice prosthesis containing a one-way valve such as a BLOM-SINGER® voice prosthesis is inserted into the tracheoesophageal fistula. The one-way valve protects the airway during swallowing but opens under positive pressure. The voice prosthesis, thus, permits a patient to divert air from the lungs into the esophagus and out through the mouth. Speech is created during passage of air through the upper part of the esophagus.
The prosthesis maintains the fistula open, transfers air from the trachea to the esophagus for voice production and prevents esophageal leakage into the trachea during swallowing. The oral cavity which extends into the throat has a high microbial population. However, the prosthesis being in contact with moisture in a hot, dark, nutrient rich environment is subject to growth of commonly found micro-organisms, typically Candida, on the valve and the retaining flange. The microbial attack is currently being studied. The microbial attack organisms and sequence of events are quite complex and are still undetermined. The microbial growth on and into the soft silicone resin can interfere with function of the valve and cause it to leak. The fouled device must be cleaned or discarded and replaced with a new device.
The current low pressure voice prosthesis can be removed by the patient every few days and can be replaced with a clean prosthesis. The removed prosthesis is soaked in hydrogen peroxide to sterilize the valve and flange. Some patients however, have difficulty managing frequent removal and reinsertion of the prosthesis. Others, who are physically handicapped are not able to remove, sterilize, or reinsert the prosthesis.
A longer dwelling, low pressure voice prosthesis has been developed that can remain in place in the tracheoesophageal fistula for many weeks or months, depending on the patient and conditions of use. The patient can confidently use the prosthesis for longer periods. The longer dwelling voice prosthesis is not removable by the patient. Trips to a health care specialist to remove and replace the prosthesis are greatly extended providing increased comfort and lower cost to the patient.
STATEMENT OF THE PRIOR ART
Between trips to a health care specialist, the voice prosthesis can be cleaned by scrubbing the central passage and valve of the prosthesis with a brush. However, the currently available brush system can pass through the valve and can injure the opposed esophageal wall even though this proximal end of the wire brush is coated with resin and a washer is disposed at the start of the bristles.
STATEMENT OF THE INVENTION
An improved brush for a voice prosthesis is provided by this invention. The brush is so structured that the bristled end of the brush is prevented from reaching the esophageal wall. The brush is adapted to be used with a voice prosthesis containing a cylindrical rigid cartridge within a soft outer body as disclosed in commonly assigned U.S. Pat. No. 5,578,083, the disclosure of which is expressly incorporated herein by reference. The brush can also be used with voice prosthesis containing a rigid valve seat within a soft outer body. The proximal end of the cartridge or valve seat extends into the central passage of the prosthesis forming a stop surface. A reduced diameter passage extends distally from the stop surface. The proximal end of the brush includes a rod from which the bristles extend. The proximal end of the rod is larger than the passage and abuts on the stop surface. The bristles, which can be mounted on a coiled wire, extends through the cartridge preferably up to the distal flange of the body of the prosthesis such that the bristles contact the valve element. The bristled section can be longer than the cartridge or valve seat and rear portion of the body. Preferably the bristle portion ends at about the rear flange of the prosthesis or at the end of a distal hood, if present.
These and many other features and attendant advantages of the invention will become apparent as the invention becomes better understood by reference to the following detailed description when considered in conjunction with the accompany drawings.
REFERENCES:
patent: 2232358 (1941-02-01), Baerer
patent: 2496381 (1950-02-01), Cummings
patent: 3613664 (1971-10-01), Willson
patent: 4819291 (1989-04-01), Gunjan
patent: 4889106 (1989-12-01), Watanabe
patent: 5003657 (1991-04-01), Boiteau et al.
patent: 5253386 (1993-10-01), Lalonde
patent: 5578083 (1996-11-01), Laguette et al.
Mudd Christopher S.
Seder Edmund V.
Helix Medical, Inc.
Jacobs Marvin E.
Till Terrence R.
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