Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
1999-08-24
2001-09-25
Mancene, Gene (Department: 3732)
Surgery
Instruments
Means for inserting or removing conduit within body
Reexamination Certificate
active
06293951
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is generally directed to a device, system, and method for treating Chronic Obstructive Pulmonary Disease (COPD). The present invention is more particularly directed to such a device, system and method which provide lung size reduction without requiring invasive surgery.
Chronic Obstructive Pulmonary Disease (COPD) has become a major cause of morbidity and mortality in the United States over the last three decades. COPD is characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction in COPD is due largely to structural abnormalities in the smaller airways. Important causes are inflammation, fibrosis, goblet cell metaplasia , and smooth muscle hypertrophy in terminal bronchioles.
The incidence, prevalence, and heath-related costs of COPD are on the rise. Mortality due to COPD is also on the rise. In 1991 COPD was the fourth leading cause of death in the United States and had increased 33% since 1979.
COPD affects the patient's whole life. It has three main symptoms: cough; breathlessness; and wheeze. At first, breathlessness may be noticed when running for a bus, digging in the garden, or walking up hill. Later, it may be noticed when simply walking in the kitchen. Over time, it may occur with less and less effort until it is present all of the time.
COPD is a progressive disease and currently has no cure. Current treatments for COPD include the prevention of further respiratory damage, pharmacotherapy, and surgery. Each is discussed below.
The prevention of further respiratory damage entails the adoption of a healthy lifestyle. Smoking cessation is believed to be the single most important therapeutic intervention. However, regular exercise and weight control are also important. Patients whose symptoms restrict their daily activities or who otherwise have an impaired quality of life may require a pulmonary rehabilitation program including ventilatory muscle training and breathing retraining. Long-term oxygen therapy may also become necessary.
Pharmacotherapy may include bronchodilator therapy to open up the airways as much as possible or inhaled &bgr;-agonists. For those patients who respond poorly to the foregoing or who have persistent symptoms, pratropium bromide may be indicated. Further, courses of steroids, such as corticosterocds, may be required. Lastly, antibiotics may be required to prevent infections and influenza and pheumococcal vaccines may be routinely administered. Unfortunately, there is no evidence that early, regular use of pharmacotherapy will alter the progression of COPD.
About 40 years ago, it was first postulated that the tethering force that tends to keep the intrathoracic airways open was lost in emphysema and that by surgically removing the most affected parts of the lungs, the force could be partially restored. Although the surgery was deemed promising, the procedure was abandoned.
The lung volume reduction surgery (LVRS) was later revived. In the early 1990's, hundreds of patients underwent the procedure. However, the procedure has fallen out of favor due to the fact that Medicare stopping reimbursing for LVRS. Unfortunately, data is relatively scarce and many factors conspire to make what data exists difficult to interpret. The procedure is currently under review in a controlled clinical trial. However, what data does exist tends to indicate that patients benefited from the procedure in terms of an increase in forced expiratory volume, a decrease in total lung capacity, and a significant improvement in lung function, dyspnea, and quality of life.
Improvements in pulmonary function after LVRS have been attributed to at least four possible mechanisms. These include enhanced elastic recoil, correction of ventilation/perfusion mismatch, improved efficiency of respiratory muscaulature, and improved right ventricular filling.
Lastly, lung transplantation is also an option. Today, COPD is the most common diagnosis for which lung transplantation is considered. Unfortunately, this consideration is given for only those with advanced COPD. Given the limited availability of donor organs, lung transplant is far from being available to all patients.
In view of the foregoing, there in a need in the art for a new and improved therapy for COPD. More specifically, there is a need for such a therapy which provides more permanent results than pharmacotherapy while being less invasive and traumatic than LVRS. The present invention is directed to a device, system, and method which provide such an improved therapy for COPD.
SUMMARY OF THE INVENTION
The present invention provides a method of reducing the size of a lung including the step of permanently collapsing at least a portion of the lung. In accordance with a first embodiment, the lung may be collapsed by obstructing an air passageway communicating with the lung portion to be collapsed. The air passageway may be obstructed by placing an obstructing member in the air passageway. The obstructing member may be a plug-like device which precludes air flow in both directions or a one-way valve which permits air to be exhaled from the lung portion to be collapsed while precluding air from being inhaled into the lung portion. Once the air passageway is sealed, the residual air within the lung will be absorbed over time to cause the lung portion to collapse.
In accordance with a further embodiment of the present invention, the lung portion may be collapsed by inserting a conduit into the air passageway communicating with the lung portion to be collapsed, pulling a vacuum in the lung portion through the conduit to collapse the lung portion, and maintaining the lung portion in a collapsed state. The lung portion may be maintained in a collapsed state by sealing the air passageway with an obstructing member or by placing a one-way valve in the air passageway. To efficiently pull the vacuum in the lung portion to be collapsed, the space between the outer surface of the conduit and the inner surface of the air passageway may be sealed as the vacuum is pulled. Preferably, the air passageway is sealed while the lung portion is collapsed.
The present invention further provides a device for reducing the size of a lung. The device includes an obstructing member insertable into an air passageway communicating with a portion of the lung to be reduced in size and having an inner dimension. The obstructing member has an outer dimension for continuous contact with the air passageway inner dimension and sealing the air passageway upon placement in the air passageway for collapsing the portion of the lung and reducing the size of the lung. The obstructing member may be formed of resilient material so as to be collapsible for initial insertion into the air passageway in a collapsed condition and releasable to define the outer dimension upon placement in the air passageway. In accordance with a further embodiment of the present invention, the obstructing member may include a one-way valve to permit exhaled air to flow from the lung portion while precluding inhaled air from flowing into the lung portion.
The present invention further provides a system for reducing the size of a lung. This system includes a conduit configured to be passed down a trachea, into a bronchus communicating with the trachea, and into an air passageway communicating the bronchus with a lung portion to be reduced in size. The system further includes an obstructing member configured to be guided through the conduit into the air passageway for placement in the air passageway and sealing the air passageway for collapsing the lung portion. The conduit preferably has an outer dimension smaller than the inner dimension of the passageway and a sealing member seals the space between the conduit outer dimension and the air passageway inner dimension as the vacuum is pulled the system may further include a vacuum source for pulling a vacuum in the lung portion through the conduit prior to placement of the obstructing member. The sealing member may be an inflatable me
Alferness Clifton A.
Jaeger Wilfred E.
Lin Richard Y.
Graybeal Jackson Haley LLP
Mancene Gene
Robert Eduardo C.
Spiration, Inc.
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