Endotracheal tube

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

Reexamination Certificate

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Details

C128S207150, C604S096010

Reexamination Certificate

active

06609521

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to the field of endotracheal tubes. More particularly, this invention deals with an apparatus and process for placing an endotracheal tube so that one or both lungs may be ventilated during an operation.
BACKGROUND OF THE INVENTION
It is a common practice to provide human medical patients with artificial ventilation during surgery or in emergency situations. For example, accident victims will frequently require CPR or intubation by a paramedic in an emergency vehicle or by an anesthesiologist in an operating room. There are other surgical procedures which require use of an endotracheal tube to collapse one lung. For example, taking a biopsy from the lung to gather information on an infection, repairing a lobar defect due to infant emphysema, removing tumors, repairing an abscess or doing an esophageal triage. Generally, an endotracheal tube for collapsing one lung requires two separate passages, or “lumens”.
Intubation is accomplished by insertion of an endotracheal tube through the patient's mouth or nasal passages into the airway passage. Such devices have generally comprised a relatively pliable tube with means for connecting it to a respirator or other air supply mechanism for introduction of air into the lungs. An improvement to endotracheal tubes includes an inflatable/deflatable bag-like structure or balloon “cuff” around the exterior of the tube. The balloon cuff is conventionally located in a position along the endotracheal tube to engage the inner wall of the pharynx, larynx, or trachea depending upon the specific endotracheal tube design. When the tube is in place, the cuff is inflated and forms an air tight seal between the tube and the surrounding body tissue to prevent the escape of air pumped from the respirator into the lungs.
Both single lumen and double lumen endotracheal tubes are known. Typically, a single lumen endotracheal tube is an elongated tube that extends into the trachea of a patient upon intubation and includes one inflatable balloon cuff near its distal end. Commonly, the double lumen endotracheal tube is referred to as an endobronchial tube and, in addition to one lumen which extends to the trachea, has a second longer lumen which extends into the bronchus of a patient upon intubation. Typically, the double lumen endotracheal tube or endobronchial tube includes two inflatable balloon cuffs. The so-called double lumen endobronchial tubes, such as the well known “Carlens” and “Robertshaw” tubes, allow for independent control of each lung through the separate lumina. One bronchus may be blocked by occluding one of the lumina at a position external to the patient, in order to isolate a particular lung.
The balloon cuffs are thin walled, high volume, and low pressure chambers or vessels which are designed not to compromise the blood flow in the tracheal or bronchial wall when inflated. Balloon cuffs are inflated by detachable syringes that are connected to smaller lumina or channels at the proximal end of the endotracheal tube. The seals formed by the inflated cuffs preclude the air that has been forced into the patient's lungs from escaping through the trachea or bronchus. Additionally, the seals formed by the inflated cuffs provide a barrier to the flow of blood, mucus, and secretions.
The so-called double lumen endobronchial tubes also offer anesthesiologists the ability to insufflate selectively either the right or left lung or both lungs as required. The so-called double lumen endobronchial tubes also offer the physician the ability to collapse either lung as needed for certain procedures. The size of endotracheal tubes and endobronchial tubes is limited. In order to minimize damage to the tissue on the tracheal wall, the overall outer diameter of both single and double lumen endobronchial tubes is limited to approximately 1.2 cm. For this reason, the inner diameter of each lumen of a double lumen endobronchial tube is by necessity smaller than the inner diameter of a single lumen endotracheal tube. As a result, the inner diameter of the single lumen endotracheal tube can typically be no more than about 7.5 mm; whereas, the inner diameter of each lumen in a double lumen endobronchial tube is limited to a maximum of approximately 3.5 mm.
When an endotracheal tube is needed for pediatric use, the size limitations are even more restrictive. In pediatric patients, the size of the trachea is approximately the same size as the patient's pinky finger. The size limitations virtually eliminate double lumen endotracheal tubes for infants since one or both of the lumens must have such a small diameter that the volumes of air or other gas that can be moved through the small lumen are less than that required by the patient. As a result, a single lumen endotracheal tube is required for procedures involving infant or toddler pediatric patients.
In pediatric patients, a single lumen endotracheal tube is advanced into the bronchus until breath sounds on the operative lung disappear. A fiberoptic bronchoscope may be passed along the endotracheal tube to confirm or guide placement of the endotracheal tube. There may be problems with such a procedure. The problems include incomplete collapse of the operated lung or failure to prevent contamination of the healthy, ventilated lung. Other techniques include use of two single lumen endotracheal tubes (one to each lung), use of a bronchial blocker to seal the lung and cause it to collapse. Use of a bronchial blocker generally requires more time than the previous method.
The larger lumen provided in a single lumen endotracheal tube affords the anesthesiologist access for other instrumentation through the lumen as required. The removal of mucus, the injection of medication, or the insertion of fiberoptic instrumentation for viewing within the endotracheal tube are examples of the additional instrumentation capability which is afforded by a single lumen tube. The ability to insert fiberoptic instrumentation through the tube significantly aids the anesthesiologist during intubation to accurately determine if the endobronchial tube is correctly positioned within the trachea and bronchus of the patient. These capabilities are restricted, if not prohibited, in the double lumen endobronchial tubes which by necessity have more narrow inner diameter passages and afford less access through the tubes by the anesthesiologist for the probes and instrumentation described.
For these and other reasons both prior art single and double lumen tubes are not fully satisfactory. There is a need for an endotracheal tube that can be inserted and quickly located in the correct position. There is also a need for an endotracheal tube that can be used to collapse one lung while ventilating the other lung. There is also a need for a single lumen endotracheal tube that can be used in pediatric patients. There is also a need for catheters that can be sealed at their distal ends.
SUMMARY OF THE INVENTION
The present invention is directed to an endotracheal tube which can be inserted through the mouth or nose and past the larynx of a patient and into the tracheal and mainstem bronchial passages. Extending from the tracheal portion of the tube is a bronchial portion which may be placed in either the left or right mainstem bronchus (singular) of the patient. The bronchial portion is angled with respect to the tracheal portion. The size of the angle corresponds to the angle between the trachea and the mainstream bronchus of the patient. Generally, these angles are age dependent and are known. The single lumen of the endobronchial tube of the present invention has an inner diameter sufficient to allow access through the single lumen to the patient's lungs and respiratory system with additional instrumentation, as required. The bronchial portion of the endotracheal tube has a balloon situated on the inside of the tube which can be inflated or deflated. By inflating the balloon, the lung into which the bronchial portion has been advanced can be collapsed so that selected surgical proced

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