Method of manufacturing a neck flange

Details Method of manufacturing a neck flange Method of manufacturing a neck flange

1995-06-05

2001-09-04

Ortiz, Angela (Department: 1732)

Plastic and nonmetallic article shaping or treating: processes

Mechanical shaping or molding to form or reform shaped article

To produce composite, plural part or multilayered article

C264S255000, C264S267000

Reexamination Certificate

active

06284179

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to a neck flange for a tracheostomy tube that provides comfort and adjustability when used to secure the tracheostomy tube to the patient's neck. The neck flange has a neck engaging portion made of a flexible material and an interconnection positioned centrally within it that is made of a material less flexible than the neck engaging portion. The interconnection supports a tracheostomy cannula having a restricted motion substantially within a plane generally normal to the neck engaging portion. The flexible and less flexible materials are molded by the step of preparing a part from one material and then insert molding the other material over it. They may be made of transparent materials.
BACKGROUND OF THE DISCLOSURE
Flexible neck flanges or flanges with pivotal joints to mount them to the tracheostomy tube are commercially available. U.S. Pat. Nos. 3,659,612 and 3,693,624 employ a neck flange of a flat plastic material pivotally connected to a tracheostomy tube. The tracheostomy tube and the neck flange are movably connected by pivots on the neck flange that fit into recesses in the tracheostomy tube. U.S. Pat. No. 4,033,353 describes a neck flange made of a flexible material to which a tracheostomy tube is mounted by flexible portions thereof. Specifically, thin webs of neck flange material between the tracheostomy tube and the part of the flange that is to be secured to the patient's neck provide the flexible portion.
U.S. Pat. No. 4,906,234 has a holder for medical tubes that provides axial adjustment along the tube for placement of an endotracheal tube within different areas of the oral cavity. A band fitted around the head cooperates with a releasable anchor so the holder may be laterally adjusted. The patent has no description for adapting the device to the curvature near the oral cavity of the patient. An endotracheal tube has no percutaneous intrusion and is not intended to be fitted to the human neck.
U.S. Pat. No. 4,332,245 has a neck flange with J-shaped clips that hooks onto a retention member that fits around the patient's neck. The neck flange and an integrated tube are made of the same material. In this device, flexibility is dependent on wall thickness and not the physical properties of the materials of construction.
U.S. Pat. No. 4,315,505 has a tracheostomy tube with a molded external end designed to receive a disposable inner cannula to facilitate cleaning. The molded end includes recesses to receive pins on the neck flange. This allows pivotal movement between the tube and the neck flange. The neck flange must be rigid enough to retain the position of the pins and maintain the pins in their respective recesses. This design makes examination of the neck below the inserted inner cannula tube difficult.
The art fails to disclosure a neck flange with a neck engaging portion that is made of a flexible material and an interconnection positioned centrally within the neck engaging portion made of a material that is less flexible. The art fails to suggest neck flanges made of transparent materials or neck flanges made by insert molding.
SUMMARY OF THE INVENTION
This invention relates to a tracheostomy tube containing a neck flange comprising a neck engaging portion and an interconnection positioned within the neck engaging portion. The neck engaging portion is more flexible than the interconnection. This difference in flexibility stems from their respective materials of construction. The neck engaging portion is made of a material that is more flexible than the material used in making the interconnection. The interconnection carries a tracheostomy tube outer cannula for limited movement relative to the neck engaging portion. The interconnection within the neck engaging portion is made by insert molding. The manner of molding of the neck flange and/or its parts of transparent materials are one of the improvements provided by the invention. This feature of the invention allows medical practitioners to observe entry of the tube into the patients neck.
The neck flange for the tracheostomy tube positions and supports the tube. The tube is inserted into the neck of a human. The neck flange preferably includes a neck engaging portion comprises a thin flexible flat sheet with a pair of essentially parallel major surfaces defined by edges therearound and an aperture in it that is generally centrally located. The neck engaging portion is most preferably molded of a flexible, transparent polymer material.
Affixed centrally in the neck engaging portion is the interconnection. The interconnection is a ring-shaped body with an opening and a pair of opposed pivot pins extending into the opening for carrying the tracheostomy tube passing therethrough. The pair of opposed pins are preferably held f or movement in respective recesses in the tracheostomy tube thus permitting limited swivel-motion thereof substantially within a plane generally normal to one major surface of the neck engaging portion.
The interconnection is most preferably molded of a transparent polymer material less flexible than the neck engaging portion and has a stepped cross section so the pair of opposed pivot pins are raised relative to the ring shaped body. The neck engaging portion may preferably be molded of a polymer about the interconnection and the raised pair of opposed pins remain exposed. The interconnection is perhaps molded of a polymer having a durometer of approximately 70-100 85 Shore D per ASTM D-785 and the durometer of the neck engaging portion may have a durometer in the range of approximately 85 or 90 Shore A per ASTM D-2240.
The method of manufacture of a neck flange having a neck engaging portion of a flexible material and an interconnection of a less flexible material includes the steps of molding a ring shaped interconnection of a relatively rigid polymer and overmolding a neck engaging portion about the interconnection in a process that may require inserting the ring shaped interconnection into a mold before molding the neck engaging portion thereabout. The method may include the step of selecting polymers that are flexible so that the neck engaging portion is more flexible than the ring shaped interconnection.
The method for using a neck flange for a tracheostomy tube with a neck engaging portion of a flexible material and an interconnection of a less flexible material most preferably has the steps of placing the tracheostomy tube into an entry in a patient's neck and swiveling the neck engaging portion relative to the tracheostomy tube so as to conform the neck engaging portion to the patient's neck. Those steps may be followed by flexing the neck engaging portion to conform to the curvature surrounding the opening in the patient's neck and observing the condition of the entry into the neck under the transparent interconnection or the transparent neck engaging portion.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1
is a perspective view of a neck flange of the preferred embodiment shown with a tracheostomy tube in position against and within the patient's neck and, for clarity, part of the neck and neck flange is sectioned away.
FIG. 2
is a front end view of the preferred neck flange and a tracheostomy tube is shown in combination with an inner cannula and cuff with its inflation tube.
FIG. 3
is a side view in cross section of the neck flange of
FIG. 2
as would be seen if the cross section were taken along line
3
—
3
in FIG.
2
and the tracheostomy tube were not included.
FIG. 4
is a side view in cross section of the neck flange of
FIG. 3
or as would be seen if the cross section were taken along line
4
—
4
in FIG.
3
and the tracheostomy tube were not included.
FIG. 5
is front view of the interconnection that is less flexible than the neck engaging portion and interconnection which is insert molded within the neck engaging portion.


REFERENCES:
patent: 3659612 (1972-05-01), Shiley et al.
patent: 3693624 (1972-09-01), Shiley et al.
patent: 4033353 (1977-07-01), La Rosa
patent: 4040670 (1977-08-01)

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