Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2000-02-03
2002-05-28
Weiss, John G. (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S912000
Reexamination Certificate
active
06394092
ABSTRACT:
CROSS-REFERENCES
There are no applications related to this application filed in this or any foreign country.
BACKGROUND
Patients with breathing problems may be assisted in the breathing process by a ventilator system. Unfortunately, due to the multi-component design from which the most widely used assisted breathing apparatus is assembled, a serious hazard exists due to the tendency of certain components to separate.
Ventilator systems include tracheal and endo-tracheal types. Endo-tracheal tubes pass through the patient's mouth, while tracheal tubes pass through a hole made in the patient's trachea. Generally, tracheal tubes assist patients who have longer-term breathing problems, while an endo-tracheal tube passing through the patient's mouth is used to assist patients with shorter-term breathing problems.
Referring to the prior art view of
FIG. 1
, an exploded view of the prior art endo
24
tracheal apparatus is seen. This apparatus includes a central ventilator adapter
100
, which is attached to a ventilator attachment
120
having both in and out vents, a suction port
140
and suction adapter
150
, and a cap
160
for terminating a dead end or auxiliary port on the central ventilator adapter. An endo-tracheal adapter
180
, extending from the endo-tracheal tube
200
, is also attached to the central ventilator adaptor
100
. The endo-tracheal tube is then positioned within the patient's trachea, where it provides breathing assistance.
A serious hazard exists for patients using endo-tracheal tubes to assist in the breathing process. Unfortunately, it is common for the endo-tracheal adapter
180
to separate, or “pop off,” from the central ventilator adapter
100
. This is because this fitting is of the friction-fit type, and requires little force to cause it to fail. In the event of failure, the patent is unable to breathe, and will require immediate medical assistance in reassembling the tubes.
This safety issue is a difficult one for which to find a solution. In particular, the central ventilator adapter and related components have been adopted in an overwhelming and widespread manner. Additionally, there is general satisfaction overall with this apparatus, despite the safety issue disclosed above. Therefore, it is unlikely that an improved substitute could achieve commercial success, and therefore it is unlikely that an improved substitute could result in the saving of lives. Prior art solutions to the problem of tube separation have utilized different structures, and would therefore be unlikely to achieve commercial or medical success.
A similar serious safety hazard exists for patients using tracheal tubes to assist in the breathing process. Where the patient requires long-term care, a tracheal tube
300
is inserted into the patient's trachea. In this circumstance, a tracheal adapter
350
is attached to both the ventilator attachment
120
and to the tracheal tube
300
. It is unfortunately the case that the tracheal tube will frequently separate from the ventilator attachment. This is because this fitting is of the friction-fit type, and requires little force to cause it to fail. In the event of failure, the patent is unable to breathe, and will require immediate medical assistance in reassembling the tubes.
This safety issue is also a difficult one for which to find a solution. In particular, the tracheal adapter
350
has been adopted in an overwhelming and widespread manner. Additionally, there is general satisfaction overall with this apparatus, despite the safety issue disclosed above. Therefore, it is unlikely that an improved substitute could achieve commercial success, and therefore it is unlikely that an improved substitute could result in the saving of lives. Prior art solutions to the problem of tube separation have utilized different structures, and would therefore be unlikely to achieve commercial or medial success.
What is needed is a safety device which could be used in conjunction with the widely used components associated with assisted breathing in both endo-tracheal and tracheal applications. The safety device should not require medical facilities to discontinue purchases of the current components, but should instead be adapted to work with components that have already been commercially adopted in a widespread manner. The safety device should also be adapted for use with both tracheal and endo-tracheal applications.
SUMMARY
The present invention is directed to an apparatus that satisfies the above needs. A novel safety device adapted for both tracheal and endo-tracheal use is disclosed that is adapted for use in conjunction with an industry standard central ventilator adapter, ventilator attachment and related components. The safety device does not require medical facilities to discontinue purchases of the current components, but instead is adapted to work with components that have already been adopted in a widespread manner.
In a tracheal application, a tracheal tube
300
extends from the patient's trachea, passes through a fastening plate
330
, and attaches to a tracheal adapter
350
. The tracheal adapter in turn attaches to a ventilator attachment
120
, which which supplies and removes air. A middle portion of a tracheal tie
320
extends behind the patient's neck, while the ends of the tracheal ties typically pass through holes defined in the fastening plate and then fold back against themselves where they are attached by VELCRO® or similar fastener, thereby preventing the unwanted movement of the tracheal tube. Due to the nature of the mechanical fit of the various components described, and their frictional attachment to one another, there is a connection
340
prone to accidental separation between the tracheal tube
300
and the tracheal adapter
350
.
To prevent this separation, the end of the tracheal adapter
350
most distant from the patient is passed through the tube passage
25
defined within a fastening ring
20
. The ends of the tracheal ties
320
, which are ordinarily attached through the fastening plate, are extended to pass through tie passages
29
defined in diametrically opposed blunt end portions
22
of the fastening ring. The ends of the tracheal ties are then folded back against themselves for fastening with VELCRO® or similar fastener. Unwanted movement of the tracheal tube is thereby prevented, as in the prior art, but additionally the tracheal adapter
350
is held in place with respect to the tracheal tube
300
, preventing unwanted separation between the two.
In an endo-tracheal application, a ventilation adapter
100
supports a ventilator attachment
120
, which supplies and removes air. The ventilation adapter also connects to an endo-tracheal adapter
180
, which in turn connects to an endo-tracheal tube. Due to the nature of the mechanical fit of the various components described, and their frictional attachment to one another, there is a connection
220
prone to accidental separation between the endo-tracheal adapter
180
and the ventilation adapter
100
.
To prevent this separation, the auxiliary port
102
and the ventilator attachment port
104
of the ventilation adapter
100
are each inserted into the tube passage
25
defined within first and second fastening rings
20
. Each fastening ring is oriented so that the inner surfaces face the ventilation adapter
100
.
A fastening bracket
60
attaches to both fastening rings, holding the assisted breathing components together. The U-shaped opening
62
defined in the body
61
of a fastening bracket
60
is carried about the endo-tracheal adapter
180
. The pair of elongated legs
65
extending from the body pass through the fastener passages
27
defined in one of the blunt ends, in each of the first and second fastening rings, and connect by snapping against the lock support surface
28
of each ring.
It is therefore a primary advantage of the present invention to provide a novel fastening structure which prevents the unwanted separation of ventilation tubes in both a tracheal and an endo-tracheal assisted bre
Barrett Kimberly L.
Bendio Jeff
Krzyzanek Jessica A.
Mitchell Teena
Thompson David S.
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