Heat and moisture exchanger adapter to closed suction...

Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...

Reexamination Certificate

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C128S205120, C128S205190, C128S207140, C604S035000, C604S118000, C604S264000, C604S538000, C604S539000

Reexamination Certificate

active

06588427

ABSTRACT:

BACKGROUND
There are a number of different circumstances in which it is necessary for a person to have an artificial airway, such as a tracheostomy tube, placed in his or her respiratory tract. As used herein, the phrase “artificial airway” includes devices such as tracheostomy tubes, endotracheal tubes and the like. Artificial airways keep the patient's natural airway open so that adequate lung ventilation can be maintained. In particular situations, the artificial airway must be left in the patient for a prolonged period of time. For example, many persons suffering severe neck or head trauma use a tracheostomy tube in conjunction with mechanical ventilation during extended recovery and rehabilitation periods.
Additionally, certain tracheostomy tube patients have tracheostomy tubes but are not mechanically ventilated. A number of these patients use heat and moisture exchangers in order to assist in heat and moisture control of the inhaled air. Many of these patients, like those being only mechanically ventilated, require mechanical secretion removal by use of a suction catheter.
Secretion removal is typically accomplished by a respiratory suction catheter that is advanced into and through the tracheostomy tube. As the suction catheter is withdrawn, a negative pressure or vacuum is applied to draw mucus and other secretions from the patient's airway interior of the artificial airway. While a substantial amount of mucus and other secretions will be withdrawn through the lumen of the suction catheter, a portion of the mucus and other secretions will remain as a film on the outside of the catheter.
With conventional closed suction catheter assemblies, for example as the one set forth in U.S. Pat. No. 4,569,344, which is assigned to the assignee of the present invention and is incorporated herein in its entirety for all purposes, the catheter tube is enveloped by a protective sleeve. The catheter assembly includes a valve mechanism in communication with a vacuum source to control the suctioning process. At its distal or patient end, the closed suction catheter assembly is attached to the artificial airway via a manifold, connector, adapter, or the like. When it is desired to remove secretions and mucus from the patient's respiratory tract, the catheter is advanced through the protective sleeve and into the patient's respiratory system through the artificial airway. Negative pressure is then applied to the proximal or clinician end of the catheter tube to evacuate the secretions and mucus. The tube is then withdrawn from the artificial airway and, as the catheter tube is pulled back into the protective sleeve, a wiper or seal strips or scrapes a substantial portion of any mucus or secretions from the outside of the catheter tube. However, the distal tip portion of the catheter tube may not pass through the seal or wiper and thus any secretions or mucus on the distal end must be removed by other means.
Some closed suction catheter assemblies include a lavage port for injecting a cleaning/lavage solution into a chamber at the distal end of the catheter assembly as suction is applied through the catheter tube for loosening and removing the secretions and mucus scraped from the exterior of the catheter tube. This procedure may be done with the catheter attached to or removed from the artificial airway and the ventilation circuit.
In certain situations, the lavage injection and suctioning process may not adequately remove the secretions and mucus adhering to the distal tip of the catheter tube and the clinician may repeat the cleaning process a number of times in an attempt to clean the catheter tip. If the mucus and secretions accumulate or dry on the catheter tip, they can cause infections or interfere with the suction efficiency of the catheter and necessitate premature replacement of the entire closed catheter suction assembly.
While a substantial amount of the mucus and other secretions may be withdrawn through the catheter, a portion of the mucus and other secretions remain on the outside of the catheter. Because patient's secretions can contain infectious agents, such as streptococcus, pseudonomas, staphylococcus, and HIV, it is important to shield clinicians from contact with the catheter. Likewise, it is important to shield patients from communicable pathogens in the environment and those that may be carried by the clinician. This is particularly important because patients using artificial airways often have compromised immune systems.
In normal breathing, the structures of the nose and sinus passages serve to heat and moisturize inhaled air. In situations where a patient may require mechanical ventilation on a periodic basis, it is common to place a heat and moisture exchanger (HME) on the proximal end of the artificial airway after removal of the mechanical ventilator. This type of placement is commonly done with patients who are able to breathe on their own for an extended period of time. In such systems and as used herein “proximal” refers to the direction towards the clinician and “distal” refers to the direction towards the patient.
The HME is intended to replicate the functions of heating and moisturizing air in patients having artificial airways. The HME is adapted to reduce heat and moisture loss from the respiratory system of the patient as the patient breathes. This is done by retaining the heat and moisture from air which is exhaled through the HME, and by warming and moisturizing air that is inhaled through the HME. The HME typically includes a material, such as porous foam, that is enclosed within a housing or other structure.
To date, most HMEs have not been used in conjunction with a closed suction catheter assembly. Thus, prior to suctioning respiratory secretions from a patient, it may be necessary to remove the HME from the proximal end of the artificial airway so that a suctioning catheter may be advanced to the patient's natural airways. Removal and attachment of the HME often causes discomfort to the patient and, during the period in which the HME has been removed, the patient is deprived of heat and moisture exchange and may be deprived of supplemental oxygen, if used.
Thus, there is a need for an inexpensive adapter that enables a closed suction catheter assembly that is configured to adequately remove secretions from the catheter to be easily and quickly attached to and removed from an HME that is mounted to an artificial airway while minimizing patient discomfort.
SUMMARY
Various features and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned from practice of the present invention.
The present invention provides for an endotracheal suction catheter apparatus that has a distal end. The distal end may be configured for allowing a catheter to be moved through the distal end and into the respiratory tract of a patient. The distal end defines a cleaning chamber where the catheter may be cleaned. A flap is located in the distal end and is located on one end of the cleaning chamber. The flap effects fluid flow within the cleaning chamber during cleaning of the catheter. Also, a connection member is present and is attached to the distal end. The connection member is configured for releasably engaging a heat and moisture exchanger so that the catheter may be advanced through the distal end into the heat and moisture exchanger.
Also provided according to the present invention is an embodiment of the endotracheal suction catheter apparatus as immediately discussed where an opening member is present and is disposed on the distal end or on the connection member. The opening member is configured for opening the heat and moisture exchanger when the opening member engages the heat and moisture exchanger.
The present invention also provides for a shipping plug that is used with the endotracheal suction catheter apparatus. The shipping plug has a body with an end that is configured to engage and limit the movement of the flap valve located within the

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