Disposable tracheostomy inner cannula connector

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

Reexamination Certificate

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C604S264000, C604S535000

Reexamination Certificate

active

06248099

ABSTRACT:

FIELD OF THE INVENTION
The present device relates to an improvement concerning tracheostomy tubes. The tracheostomy tubes are generally comprised of an outer cannula and a disposable inner cannula.
BACKGROUND OF THE INVENTION
Tracheostomy tubes are used in the health care field to provide a bypass supply of air or gases to a patient having an obstruction of the larynx or pharynx and who is thus no longer able to breath through the normal route. Tracheostomy tubes are also placed in patients who, because of injury or disease, cannot breath on their own. These patients are chronically dependant on mechanical ventilation and the long-term artificial airway of choice is the tracheostomy tube.
An incision is made by the doctor below the obstruction and the tube inserted. The tube then acts as a gateway, allowing the patient to breath normally, the proximal end of the tube remaining stationary outside the trachea.
The tracheostomy tube has a tendency to become either partially or completely obstructed, over time, by the accumulation of mucus or phlegm. To resolve this problem, a system where two cannulas are placed one inside the other has been developed, which allows for the removal of the inner cannula to facilitate cleaning while still maintaining the outer cannula in the patient's trachea, U.S. Pat. No. 3,693,634 to Shiley/Mallinckrodt. Problems may occur due to accidental disconnection of the inner and outer cannulas of the tracheostomy tube, thereby allowing for spillage and/or slippage between the two. This slippage may cause a disconnection a ventilator resulting in the death of the patient.
There are several devices which contain a means of connecting the inner cannula to the outer cannula and the outer cannula to the ventilation system. These include, but are not limited to, U.S. Pat. No. 3,659,612 to Shiley et al., U.S. Pat. No. 4,009,720 to Crandall, et al. and U.S. Pat. No. 3,088,466 to Nichols. Inherent in these tracheostomy tube designs is the fact that two separate connectors are required. This means that there are two disconnection points which reduces the safety of the system, the accidental disconnection of the inner cannula with the ventilation system being increased. In addition, an air tight seal must be present between the inner and outer cannula to ensure that the respiration pressure from an artificial ventilation system is maintained and leakage does not occur. Another disadvantage is that while the inner cannula is removed, the ventilator cannot be connected to the tracheostomy tube, if needed.
U.S. Pat. No. 4,817,598 to LaBombard discloses a disposable inner cannula tracheostomy tube with a ventilator connector that is permanently fixed to the outer cannula. The proximal end of the inner cannula fits into the inner diameter of the connector and is fixed with opposing ribs and grooves that create a “SNAP” connection. The inner cannula has a proximal ring that is connected by a hinge to provide a gripping surface for removal of the inner cannula from the outer cannula.
The major problem with both the LaBombard and the Shiley devices is that they are not compatible with one another. This has created a strain on consumers in the disposable inner cannula market. What is needed is a connector device which can be used in conjunction with all the available disposable inner cannulas on the market to allow interchangability of the inner cannula with the tracheostomy tube and increase its safety. Such a connector will allow the care-giver and patient to take advantage of the product benefits of the Shiley device as well as those of the LaBombard tracheostomy tube.
SUMMARY OF THE INVENTION
Wherefore, it is an object of the present invention to overcome the aforementioned problems and drawbacks associated with the prior art designs.
The device, according to the present invention, relates to tracheostomy tubes, in particular, those that are disposable and composed of an outer cannula and a disposable inner cannula. The device will allow for the interchangability between various manufacturers as well as allowing for the permanent attachment of the ventilator connector thus increasing safety to the patient.
In a preferred embodiment of the invention, the connector, used to attach the outer cannula with the inner cannula, comprises: a) a locking means; b) a standard taper; c) an annular ring; and d) securing means. The connector may be constructed from material such as polypropylene, polyethylene, polycarbonate, polyvinyl chloride or another material that is capable of maintaining rigidity during the connector's attachment. The locking means of the device projects outward from the connector's distal end and has a lip to facilitate the connector's attachment to an outer cannula. A standard 1 in 40 taper is provided on the exterior surface of the connector with a nominal outer diameter of 15 mm throughout the length of the connector. In addition, there is a compression rib attached to the distal portion of the locking means which encompasses the connector to compensate for variances in the proximal end of the connector portion of the disposable inner cannula. The annular ring has a slightly smaller diameter than the diameter of the annular protrusion of the inner cannula to provide an interference fit therebetween.
In another preferred embodiment, the connector is described through its use. Its use being a method of permanently attaching a connector to a tracheostomy outer cannula comprising a series of steps. First, a connector with an elongate housing must be provided, having a through bore extending longitudinally completely through the elongate housing. Then an inwardly facing annular ring must be located within the through bore, adjacent one end thereof, for facilitating engagement with a recess of an inner cannula. Finally, a locking mechanism is required on the connector for supporting the outer cannula in a locking engagement with the connector.
The present invention relates to a connector for interconnecting an inner cannula with an outer cannula, the connector comprising: an elongate housing defining a through bore extending longitudinally completely therethrough; an inwardly facing annular ring being located within the through bore, adjacent one end thereof, for facilitating engagement with a recess of an inner cannula; and the connector supporting a locking mechanism for facilitating a locking engagement with an outer cannula.


REFERENCES:
patent: 3088466 (1963-05-01), Nichols
patent: 3169529 (1965-02-01), Koenig
patent: 3659612 (1972-05-01), Shiley et al.
patent: 3693634 (1972-09-01), Gilbert
patent: 4009720 (1977-03-01), Crandall
patent: 4033353 (1977-07-01), La Rosa
patent: 4304228 (1981-12-01), Depel
patent: 4315505 (1982-02-01), Crandall et al.
patent: 4817598 (1989-04-01), LaBombard
patent: 5149330 (1992-09-01), Brightbill
patent: 5357952 (1994-10-01), Schuster et al.
patent: 5390669 (1995-02-01), Stuart et al.
patent: 5460176 (1995-10-01), Frigger

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