Gas supplying and substance suctioning relative to a...

Surgery – Respiratory method or device – Means placed in body opening to facilitate insertion of...

Reexamination Certificate

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Details

C128S207140, C128S207160, C128S912000

Reexamination Certificate

active

06227197

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to medical catheters and, in particular, to apparatus and method for selectively ventilating and suctioning a patient using two separate catheters.
BACKGROUND OF THE INVENTION
Delivery of oxygen to a patient using a catheter positioned within an endotracheal tube is a well-established medical procedure. The oxygen is provided to assist in maintaining adequate oxygenation and ventilation. The catheter carries the oxygen in a suitable concentration directly into the distal trachea, 2-3 cm from the carina, bypassing the upper airways. This is intended to be accomplished while avoiding ventilator-induced complications.
Patients suffering from severe respiratory or ventilatory distress are sometimes recipients of this procedure commonly known in the medical literature as Thoracic Gas Insufflation (TGI) procedures. Major steps associated with such a procedure include positioning a catheter at a predetermined location in the patient's trachea and then causing oxygen to be delivered at a desired concentration. Commonly, mucous or other substances must be removed from the patient on a periodic basis. In accordance with one known medical device and procedure, a single catheter is alternately used to first deliver a ventilating oxygen/air mixture and then used to remove substances from the patient. This single catheter is inserted into the trachea of the patient. Under operator or technician control, a selection is made to either (1) deliver an oxygen/air mixture or (2) suction unwanted substances from the patient. Oxygen/air mixture delivery and patient suctioning procedures are then alternated using the same catheter. This device is also known to maintain sterility of its single catheter by means of a collapsible bag that surrounds the single catheter and prevents unwanted exposure to the environment. However, this device utilizes a single catheter whose diameter (french size) is less than ideal for either purpose. Typically, the catheter is too large in diameter for optimal oxygen/air mixture delivery within an endotracheal tube and too small in diameter for optimal efficiency in removing unwanted substances. In the other known method, two separate and different size catheters are used. One catheter for delivering the oxygen/air mixture and another catheter for removing unwanted substances from the patient's trachea. Although each catheter may be ideally sized for its intended purpose, there is no unitary and convenient mechanism that facilitates the performing of these two functions and procedures.
SUMMARY OF THE INVENTION
In accordance with the present invention, an apparatus is provided for selectively supplying a gas including an oxygen/air mixture to a patient and for suctioning mucous or other substances from the patient. The apparatus includes a tracheal gas assembly that includes a gas catheter for carrying gas having a desired composition including a suitable concentration of oxygen to the patient. A first or gas catheter enclosure member surrounds substantial portions of the gas catheter when it is not being utilized to supply gas, to the patient's body passageway, such as the trachea. A holding or clamp member surrounds a portion of the gas catheter and is used to hold or fix the gas catheter in a desired or predetermined position relative to the trachea of the patient. Adjacent to an output end of the gas catheter, when the gas catheter is in a standby position and not being utilized to carry gas to the patient, a first or gas catheter indicator element is located or otherwise provided to indicate to the practitioner that the gas catheter is in its standby position. The gas catheter also has a continuous series of numerically labeled location markers positioned 2 cm apart beginning 10 cm from the gas catheter's output end and proceeding proximally along the gas catheter's body ending at the 42 cm. mark. These location markers enable the practitioner or operator to identify the position of the extended gas catheter's output end relative to the endotracheal tube in the patient's trachea. The gas catheter also has a radio opaque stripe running along its entire body length so that the practitioner or operator can also determine or verify the exact position of the gas catheter in the patient's trachea through the use of a chest x-ray.
The apparatus further includes a suction assembly having a second or suction catheter that is separate and detached from the gas catheter. The suction catheter is used to remove mucous or other substances from the patient when its input end is suitably located within the patient's trachea or other body passageway. Like the gas catheter, the suction catheter has substantial portions surrounded by a second or suction catheter enclosure member when the suction catheter is removed from the patient's trachea or other body passageway and is in its standby position. When the suction catheter is in its standby position, the gas catheter can be advanced and properly located in the patient's trachea. Likewise, when the gas catheter is in its standby position, the suction catheter can be advanced and properly located in the patient's trachea. The suction catheter also has a catheter position indicator element formed or otherwise provided adjacent to its input end. The suction catheter position indicator element is used to provide an indication to the practitioner or operator when the suction catheter is in its standby position.
The apparatus also includes a common or Y-connector having first and second legs. The gas catheter is able to move within and relative to the first leg and with one end of the first enclosure member being held adjacent to the first leg. Similarly, the suction catheter is able to move within and relative to the second leg. The Y-connector has a common section that communicates with each of the two legs. When the gas catheter is located within the patient's trachea, portions of the gas catheter occupy space in the common section. When the suction catheter is located within the patient's trachea, portions of the suction catheter occupy space in the common section.
The apparatus also includes a connector unit that is joined to or operatively associated with the Y-connector. The connector unit includes a T-member having a connector tube or member that is used to connect or join the Y-connector to the T-member. The T-member also has a short connector on the opposite side of the main tube that connects to the patient's endotracheal tube while fluidly communicating with the T-member's main tube and joined Y-connector. When being used, the selected catheter, either the gas catheter or the suction catheter is advanced within the Y-connector, the T-member connector tube, across the main tube of the T-member through the short connector into the patient's endotracheal tube and then into the patient's trachea. The T-member's main tube also preferably has a magnifying section or element to facilitate visual recognition of a numerically labeled location markers positioned 2 cm apart beginning 10 cm from the distal tip and proceeding approximately to the 42 cm mark along the body of the catheter. The numerically labeled location markers are identically positioned on the body of both the gas catheter and the suction catheter. Such location markers, when positioned within the T-member main tube and under the magnifying element, can assist the practitioner or operator in properly positioning either of the two catheters relative to the patient's trachea. The T-member main tube will also preferably include a first swivel connector through which the entire tracheal gas assembly is operatively attached to the patient's endotracheal tube. The T-member main tube will also preferably include a second swivel connector to which a primary source of inspiratory gas and ventilatory assistance is operatively attached.
With regard to methods of operation, the apparatus of the present invention has communication

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