JPH06205835A - Neck flange and its production and usage - Google Patents

Abstract

PURPOSE: To provide an improved neck flange device for an air tube opening tube including a comparable elastic neck engagement part and a comparably stiff junction to position the air tube opening tube as well as its manufacture method and operation method. CONSTITUTION: Neck flange 11 is to support an air tube opening tube 10 put through the neck 12 and has a neck engagement part 21 including an opening made from a thin elastic plane sheet formed by a transparent polymer. The junction is placed in the center of the neck engagement part 21 and supported by it. The junction is formed with polymer material having elasticity lower than that of the neck engagement part 21 and has a stepped cross-sectional shape capable of raising a pair of opposite pivot pins higher than a ring shaped substance. The neck engagement part 21 is formed around the junction and keeps the highly raised pair of opposite pins exposed.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a tracheostomy tube neck flange which provides comfort and adjustment when used to secure a tracheostomy tube to a patient's neck. The neck flange is a neck engaging portion formed of a flexible material, and a connecting body formed of a material less flexible than the neck engaging portion disposed in the center of the neck engaging portion. Have and. The connector supports a tracheostomy cannula with limited motion in a plane substantially perpendicular to the neck engaging portion. Making the flexible material and the less flexible material partly of one material;
Then, the other material is insert-molded on a part thereof. The neck engaging portion and the connecting body can be formed of a transparent material so that the lower side of the neck flange can be seen.

[0002]

Flanges having pivotable joints for attaching the flange to a flexible neck flange or tracheostomy tube are commercially available. U.S. Pat. Nos. 3,659,612 and 3,693,624 use a neck flange formed of a flat plastic material pivotally connected to a tracheostomy tube. The tracheal opening tube and the neck flange are movably connected by a pivot on the neck flange that fits into a recess in the tracheal opening tube. U.S. Pat. No. 4,033,353 describes a neck flange formed of a flexible material to which the tracheostomy tube is attached by its flexible portion. In particular, a thin web of neck flange material between the tracheostomy tube and the portion of the flange to be secured to the patient's neck defines the flexible portion.

US Pat. No. 4,906,234 uses a medical tube holder that allows axial adjustment along the medical tube to position the endotracheal tube in different areas of the oral cavity. There is. A band mounted around the head cooperates with a releasable anchor to allow lateral adjustment of the holder. There is no mention in this patent of adapting the device to the curvature near the oral cavity of the patient. The endotracheal tube does not have any percutaneous penetration and is not intended for attachment to the human neck.

US Pat. No. 4,332,245 uses a neck flange with a J-shaped clip that hangs on a retaining member that fits around the patient's neck. The neck flange and the integral tube are made of the same material. In this device, flexibility is determined by the wall thickness rather than the physical properties of the structural material.

US Pat. No. 4,315,505 uses an endotracheal tube having a molded outer end adapted to house a disposable inner cannula that facilitates cleaning. The shaped end includes a recess that accommodates a pin on the neck flange. The neck flange must be stiff enough to hold the pin in place and maintain it in its respective recess. This design makes it difficult to inspect the neck below the inserted inner cannula tube.

In the above conventional technique, a neck engaging portion made of a flexible material and a connecting body made of a low flexible material disposed in the center of the neck engaging portion. Has not yet been disclosed. The prior art does not propose a neck flange made of transparent material or a neck flange made by insert molding.

[0007]

SUMMARY OF THE INVENTION The present invention relates to a neck flange assembly for carrying a tracheostomy tube. The neck flange assembly includes a neck engaging portion and a connector disposed within the neck engaging portion. The neck engaging portion has higher flexibility than the connecting body. This difference in flexibility arises from the respective structural materials. The neck engaging portion is formed of a material having higher flexibility than the material used to form the connector. The connector carries the tracheostomy tube outer cannula for limited movement relative to the neck engagement portion.

The connecting body in the neck engaging portion is formed by insert molding. The method of forming the neck flange assembly and parts thereof is an improvement provided by the present invention.
In the preferred embodiment of the invention, the neck flange assembly is formed from different transparent polymers. This feature of the invention is that the physician can observe the tracheostomy tube as it enters the patient's neck.

The neck flange for a tracheostomy tube is
Position and support the tube. The tracheostomy tube is inserted inside the human neck. A neck flange is a thin, flexible, flat sheet having a pair of essentially parallel large surfaces defined by one or more common edges, the sheet being generally centrally located on both sides of the sheet. It is preferred to include a neck engagement portion with an opening that is preferably centrally located relative to it. The neck engaging portion is preferably made of a transparent transparent polymer material.

A connecting body is fixed to the center of the neck engaging portion. The connector is a ring with an i) opening in common with the opening and ii) a pair of raised opposed pivot pins that carry a tracheostomy tube extending into and through the opening. . The pair of opposed pins have the same shape as the recess of the trachea opening tube, which restricts the movement of the trachea opening tube. Movement of the tracheostomy tube is generally limited to pivotal movement substantially in a plane substantially perpendicular to one large surface of the neck engaging portion, ie about the pivot pin axis.

The connecting body is preferably formed of a transparent polymer material which is less flexible than the structural material of the neck engaging portion. The cross section of the connector is stepped (positioned perpendicular to the pins) so that a pair of opposing pins are raised above the ring. The neck engaging portion is molded of polymer around the connector, and a pair of elevated hoisting pins are left exposed. The connecting body is ASTM
It is possible to mold with a polymer having a durometer hardness of about 70 to 100 on the Shore hardness D scale according to D-785, and the durometer hardness of the neck engaging portion is about on the Shore hardness A scale according to ASTM D-2240. It may have a durometer hardness in the range of 85 or 90.

A neck flange assembly in which the neck engaging portion is formed of a flexible material and the connecting body is formed of a material less flexible than the material of the neck engaging portion is first relatively rigid. Overmolding in which a connector is molded with a polymer, and the connector is molded so as to be covered with a neck engagement.
lding). Overmolding involves inserting the ring-shaped connector into a mold shaped to mold the neck engaging portion. A polymer that is more flexible than the polymer used to form the connector is then introduced into the mold and the connector is partially wrapped by the more flexible neck engaging portion.

The method of using the neck flange of the present invention comprises placing the tracheal opening tube within the entrance of the patient's neck and pivoting the neck engaging portion relative to the tracheal opening tube to move the neck engaging portion to the patient's neck. And the step of matching. Following these steps, the neck engaging portion is bent to match the curvature around the patient's neck opening and the tube is penetrated into the neck below the transparent connector or transparent neck engaging portion. I may observe the situation.

[0014]

DETAILED DESCRIPTION OF THE INVENTION It is an object of the present invention to improve a neck flange device for a tracheal opening tube that includes a relatively flexible neck engagement portion and a relatively rigid connection in which the tracheal opening tube is positioned. A method for producing the same and a method for using the same are provided. The invention is not limited to the structure of the neck flange described and illustrated by way of example, and to its particular method of manufacture and use.

FIG. 1 is a perspective view of a tracheostomy tube 10 and a preferred embodiment neck flange 11 shown with the tracheostomy tube 10 positioned relative to and within the patient's neck. Is. To make the figure easier to understand,
The neck 12 is shown with a part thereof removed. The tracheostomy tube 10 and neck flange 11 can be used for tracheostomy of a human neck 12. The tracheostomy tube 10 has a tip 13 that is disposed within a patient's neck 12 and forms a passageway 14 from a proximal end 15 that opens to an air source to aid breathing. The tracheostomy tube 10 includes a proximal end 15 that is located outside the human neck 12 when it is deployed and used. The central portion 16 is between the ends 13 and 15 of the trachea opening tube 10. The central portion 16 includes recesses 17 on both sides that intersect each other.

FIG. 2 is a front end view of the preferred neck flange 11, with the tracheal opening tube 10 shown as including an inner cannula 18 and a cuff 19 with an inflation tube 20. As can be seen from FIGS. 1 and 2, the neck flange 11 has a neck engaging portion 21 formed of a thin flexible sheet. The sheet is preferably flat, but may be curved.
The sheet includes a pair of generally parallel large surfaces 22 and 23 defined by an edge 24 thereabout, and a generally central opening therethrough. Neck engagement portion 21 of the preferred embodiment
Is preferably molded of a flexible, transparent polymeric material.

The preferred polymeric material is ASTM D-2.
It must have a durometer hardness of less than 85 Shore A scale, measured at 240. ASTM D-
A durometer hardness in the range of 70 to 80 Shore A hardness with a minimum tensile strength of 2000 psi as measured at 638 is desirable. Polymers such as polyvinyl chloride, polyurethane, or other flexible transparent medical grade polymers may be used to mold the neck engaging portion 21. The particular polymer selected has additives used to mold the neck engaging portion 21 to maintain relative clarity during and after sterilization by retort, gas or radiation up to 3.5 rads. Is preferred.

FIG. 3 is a side cross-sectional view of the neck flange 11 of FIG. 2 as can be seen from the cross section taken along line 3-3 of FIG. 2 with the tracheal opening tube 10 removed or shown. Absent. The connecting body 26 includes the neck engaging portion 21.
It is centrally located within and is carried as shown in FIG. The connecting body 26 is a ring-shaped body 27 including a central opening 28, as shown in FIGS. 3, 4, and 5. A pair of opposed pivot pins 29 extend radially inward toward each other into the opening 28 to support the central portion of the trachea opening tube extending therethrough, as illustrated in FIGS.

As shown in FIG. 3, the connecting body 26 has a stepped cross section in which a pair of opposed pivot pins 29 are mounted on a ring-shaped body 27 and lifted up. The pair of opposing pins are
A movably fit within the recess 17 of the tracheal opening tube 10 and constrained to pivot as shown by the arcuate arrow A in FIG. 1 and substantially in a plane generally perpendicular to the large surface 22 of the neck engaging portion. It is possible to move.

The connecting body 26 is formed of a transparent polymer material having a low durometer hardness, which is less flexible than the neck engaging portion 21. A suitable polymeric material for the connector 26 is ASTM
Approximately 85 on the Shore hardness D scale measured with D-785
Of durometer and an Izod impact strength of at least 4.0 ft lb / in as tested by ASTM D-256. A relatively strong, non-yielding polymer such as polycarbonate or other transparent medical grade polymer is used for the connector 26. The selected polymers preferably have additives that maintain their relative clarity during and after sterilization by retort, gas or radiation up to 3.5 rads.

FIG. 4 is a side sectional view of the neck flange 11 of FIG. 3 or a sectional view taken along line 4-4 of FIG. 2 and does not include the endotracheal tube 10. The connecting body 26 is injection-molded and used by being inserted in the molding of the neck engaging portion 21. The shape of the connector 26 is shown in FIG. As shown in the figure, the mold design for the connector and the neck engaging portion is such that the neck engaging portion 21 separates the pair of opposed pins 29 which are raised. Therefore, the connecting body 26 is formed in the suitable shape shown in FIG. The connector is then inserted into an injection molding cavity having the shape of the neck engaging portion 21 and adjusting the positioning of the connector 26. A softer and more flexible polymer is injected into the cavity to form the neck engaging portion 21. The neck flange 11 formed by this is the same as the neck engaging portion 21 except for the pivot pin 29.
Is one combination of materials surrounding the connector 26. The cross-sectional view of FIG. 3 shows that the neck engaging portion 21 encloses the ring-shaped connecting body 26 and does not enclose the pivot pin 29.

2 and 3 show a pair of D-shaped holes 30 in the neck engaging portion 21. A pair of D-shaped holes 30
Is used to attach a neck band (not shown) secured around the neck 12 and holding the tracheostomy tube 10 upon entry through the patient's neck. A D-shaped hole 30 is preferred, but may be any shape including an ellipse, oval or square as long as it fits conveniently on the neck. Each hole 30
Are spaced from the area of the neck engaging portion 21 that encloses the connector 26. The trachea 31 is shown in the form of an inflated cuff 19 near the tip 13.

[Brief description of drawings]

FIG. 1 is a neck flange of a preferred embodiment with a tracheostomy tube shown in cross-section for a portion of the neck and neck flange for clarity, shown in place relative to and within the patient's neck. FIG.

FIG. 2 is a front end view of a preferred neck flange again showing a tracheostomy tube including an internal cannula and a cuff with an inflation tube for ease of reference.

FIG. 3 is a line 3-3 of FIG. 2 not including a tracheal opening tube.
FIG. 3 is a side cross-sectional view of the neck flange of FIG. 2 similar to the cross-section taken along.

FIG. 4 is a line 4-4 of FIG. 3 not including a tracheostomy tube.
4 is a side sectional view of the neck flange of FIG. 3 similar to the section along FIG.

FIG. 5 is a front view of a connector that is less flexible than the neck engaging portion and is insert-molded in the neck engaging portion.

[Explanation of symbols]

10 trachea open tube, 11 neck flange, 1
2 necks, 21 neck engaging portions, 25 openings, 26 connected bodies, 27 ring-shaped bodies.

 ─────────────────────────────────────────────────── ─── Continued Front Page (72) Inventor Norman Crandall, California, USA 92626, Costa Mesa, Yukon Avenue 3129

Claims (22)

[Claims] 1. A neck flange for a tracheostomy tube for positioning and supporting the tracheostomy tube when inserted into a human neck, the neck flange being formed of a flexible polymeric material and having a centrally located opening. A flat sheet-like neck engaging portion having: i) a ring formed of a polymer material having a lower flexibility than the polymer material of the neck engaging portion, and ii) a through opening occupying a common space with the opening. And a iii) a connecting body which is enclosed in the central position of the neck engaging portion and is carried as a part of the neck engaging portion and is movably connected to a trachea opening tube penetrating the opening. Neck flange characterized by including. 2. The connecting body has a pair of opposed pivot pins extending inwardly toward each other into the opening,
The neck flange of claim 1, wherein the pivot pin is shaped and positioned to carry the trachea opening tube. 3. The connection allows for limited pivoting relative to the opening of the tracheal opening tube and in a plane substantially perpendicular to the neck engaging portion. The neck flange described in 2. 4. The connecting body has a stepped cross section so that the pair of opposed pivot pins can be lifted higher than one large surface of the ring-shaped body of the connecting body. The neck flange according to claim 2. 5. The neck flange according to claim 1, wherein the neck engaging portion and the connecting body are formed of different polymers. 6. The neck flange according to claim 5, wherein the connecting body is formed of a polymer having a durometer hardness higher than that of the polymer of the engaging portion. 7. The neck flange according to claim 6, wherein the polymer of the neck engaging portion is molded around the connecting body. 8. The neck flange according to claim 1, wherein the neck engaging portion and the connecting body are substantially transparent. 9. The neck flange according to claim 8, wherein the neck engaging portion and the connecting body maintain transparency even after sterilization. 10. The neck engagement portion and the connector both have a slightly reduced transparency after radiation sterilization up to 3.5 rads. Neck flange. 11. The neck flange according to claim 2, wherein the ring-shaped body is enclosed in the polymer of the neck engaging portion while leaving the pair of pivot pins in an unencapsulated state. 12. The durometer hardness of the connecting body is A.
Approximately 8 on the Shore hardness D scale according to STM D785
5. The flexibility of the pair of opposing pins is lower than that of the neck engaging portion.
The neck flange according to 1. 13. The neck flange of claim 11, wherein the durometer hardness of the neck engaging portion is in the range of about 70 to 85 on the Shore hardness D scale according to ASTM D-2240. 14. The neck flange according to claim 11, wherein the durometer hardness of the pair of opposed pins is about 85 on the Shore hardness D scale according to ASTM D785. 15. The neck flange of claim 11, wherein all but the pair of opposed pins are insert molded within the flat sheet of the neck engaging portion. 16. A method of manufacturing a neck flange having a neck engaging portion of a flexible material and a ring-shaped connector of a less flexible material, the polymer having a ring-shaped connector. Separately, the ring-shaped connector is then inserted into a mold for molding the neck engaging portion, and polymer is injected into the mold to surround the neck-shaped connector around the ring-shaped connector. A method for manufacturing a neck flange having a neck engaging portion made of a flexible material and a ring-shaped connecting body made of a less flexible material, characterized by forming a joint portion. 17. The molding step is such that the neck engaging portion is more flexible than the ring-shaped connecting body and the combination of the neck engaging portion and the connecting body is transparent. 17. A neck flange having a neck engaging portion of a flexible material and a ring-shaped coupling member of a less flexible material according to claim 16, comprising selecting a polymer that is transparent. Method of manufacturing. 18. A neck engaging portion made of a flexible and transparent material and an embedded connection body made of a transparent material having a low flexibility are provided.
A method of using a neck flange for a tracheal opening tube, wherein the neck engaging portion and the connecting body include a common opening, wherein the tracheal opening tube is disposed within an entrance of a patient's neck and includes the embedded connecting body. The neck engaging portion is pivoted about the common opening relative to the tracheal opening tube to conform to the patient's neck, the neck engaging portion conforming to a curvature about the entrance to the patient's neck. Neck for a trachea opening tube, characterized in that the trachea opening tube is connected to the connecting body, and the state of entry into the neck under the transparent connecting body and the transparent neck engaging portion can be observed. How to use the flange. 19. A neck flange for a tracheostomy tube for positioning and supporting the tracheostomy tube as it is inserted into a person's neck, the neck flange being a transparent transparent polymeric material. And a neck engaging portion which is a thin flexible sheet having a pair of substantially parallel large surfaces defined by a circle around the large surface and an opening penetrating the large surface, and a stepped cross section. And a molded body made of a transparent polymer material having lower flexibility than the neck engaging portion, centrally arranged in the neck engaging portion, and carried by the neck engaging portion, which is common to the opening. A pair of a ring-shaped body having an opening and a trachea-opening tube fixed to the ring-shaped body at a fixed position elevated to the ring-shaped body and extending into the opening and penetrating the opening. With opposite pins of And a pair of opposed pins including a connecting body, the pair of opposed pins being movably held in a recess of the trachea opening tube to allow limited movement around the axis of the pin in the trachea opening tube. Flange for tracheostomy tube for positioning and supporting the tracheostomy tube when inserting it into the neck of a person 20. The pair of opposed pins, in which the neck engaging portion is formed of a polymer around the connecting body and is raised,
20. The neck flange according to claim 19, wherein the neck flange remains exposed. 21. The neck flange according to claim 20, wherein the connecting body is formed of a polymer having a hardness higher than that of the polymer of the neck engaging portion. 22. A tip disposed within the person's neck to provide a passageway to aid breathing, and a base end disposed outside the person's neck when the tracheostomy tube is in place and in use. 20. A tracheostomy tube, comprising: a tracheostomy tube having a central portion between opposite ends thereof, the central portion including a recess transverse to one another on opposite sides thereof and the neck flange of claim 19. Tracheostomy tube and neck flange used when performing tracheostomy on a human neck.