Method and assembly for lung volume reduction

Surgery – Instruments – Suture retaining means

Reexamination Certificate

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Details

C606S144000, C606S233000, C128S898000, C623S023650

Reexamination Certificate

active

06599311

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method and assembly for reducing the volume of a lung and, more particularly, to a mechanical lung volume reduction system comprising cords and anchors that pull on portions of a lung to compress the volume of a portion of the lung.
2. Background Information
The lungs deliver oxygen to the body and remove carbon dioxide. Healthy lung tissue includes a multitude of air passageways which lead to respiratory bronchioles within the lungs. These airways eventually lead to small sacs called alveoli, where the oxygen and carbon dioxide are exchanged through the ultra-thin walls of the alveoli. This occurs deep within the lungs, in an area which is accessed by a network of airways, consisting of a series of branching tubes which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. As shown in
FIG. 1
, tiny air sacks called alveoli
1
surround both alveolar ducts
2
and respiratory bronchiole
3
throughout the lung. The alveoli are small, polyhedral recesses composed of a fibrillated connective tissue and surrounded by a few involuntary muscular and elastic fibers. These alveoli
1
inflate and deflate with air when we breathe. The alveoli are generally grouped together in a tightly packed configuration called an alveolar sac. The thin walls of the alveoli
1
perform gas exchange as we inhale and exhale.
During inhalation, as the diaphragm contracts and the ribs are raised, a vacuum is created in the chest, and air is drawn into the lungs. As the diaphragm relaxes, normal lungs act like a stretched balloon and rebound to the normal relaxed state, forcing air out of the lungs. The elasticity of the lungs is maintained by the supportive structure of the alveoli. This network of alveoli provides strength to the airway walls, as well as elasticity to the lungs, both of which contribute to the lung's ability to function effectively.
Patients with pulmonary disease have reduced lung capacity and efficiency due to the breakdown of lung tissue. This often is caused by smoking. In cases of severe chronic pulmonary disease, such as emphysema, lung tissue is destroyed, reducing the strength of the airways. This reduction and strength of the airway walls allows the walls to become “floppy” thereby losing their ability to remain open during exhalation. In the lungs of an emphysema patient, illustrated in
FIG. 2
, the walls between adjacent alveoli within the alveolar sac deteriorate. This wall deterioration is accelerated by the chemicals in smoke which affect the production of mucus in the lungs. Although the break down of the walls of the alveoli in the lungs occurs over time even in a healthy patient, this deterioration is greatly accelerated in a smoker causing the smoker's lungs to have multiple large spaces
4
with few connecting walls in the place of the much smaller and more dense alveoli spaces
1
in healthy lung tissue.
A cross section of a diseased emphysematous lung will look like Swiss cheese due to the deterioration of the alveoli walls which leaves large spaces in the tissue. In contrast, a cross section of healthy lung tissue has few or no noticeable holes because of the small size of the alveoli. When many of the walls of the alveoli
1
deteriorate, as shown in
FIG. 2
, the lung has larger open spaces
4
and a larger overall volume, but has less wall tissue to achieve gas exchange.
In this diseased state, patients suffer from the inability to get the air out of their lungs due to the collapse of the airways during exhalation. As a result, heavily diseased areas of the lung become over-inflated with the air that cannot escape due to the collapse of the airways. This air remains in the lung and is non-functional as it does not aid in the blood-gas exchange process. Because the lungs are limited to the confines of the chest cavity, this over-inflation restricts the in-flow of fresh air and hampers the proper function of healthier tissue. As a result of the over-inflation, patients experience significant breathlessness. Thus, the emphysema patient must take in a greater volume of air to achieve the same amount of gas exchange as a healthy individual. However, individuals suffering from emphysema still have insufficient gas exchange even when they take in as much air as their chest cavity can accommodate. Emphysema patients will often look barrel-chested and their shoulders will elevate as they strain to make room for their over-inflated lungs to work.
In cases of severe emphysema, lung volume reduction surgery (LVRS) improves lung efficiency of the patient and allows the patient to regain mobility. In lung volume reduction surgery, a diseased portion of an emphysematous lung having a large amount of alveolar wall deterioration is surgically removed as illustrated in FIG.
3
. LVRS is performed by opening the chest cavity, retracting the ribs, stapling off, and removing the more diseased portion of the lung
31
. This allows the remaining healthier lung tissue to inflate more fully and take greater advantage of the body's ability to inhale and exhale. Since there is more inspired air there is increased gas exchange in the healthier portion of the lung. As a result lung efficiency improves.
Lung volume reduction surgery is an extremely invasive procedure requiring the surgical opening of the chest cavity and removal of lung tissue. This surgery has substantial risks of serious post-operative complications, such as pneumothorax, and also requires an extended convalescence.
Accordingly, it is desirable to achieve the benefits of improved air exchange for emphysema patients provided by LVRS without invasive open chest surgery and the associated complications.
SUMMARY OF THE INVENTION
The present invention relates to a lung volume reduction device comprising at least one anchor having a reduced profile and being configured to assume an expanded profile wherein in the reduced profile the anchor is capable of being advanced into an airway of the lung and in the expanded profile the anchor secures to lung tissue, the anchor having at least one connector, at least one cord having a proximal end and a distal end, the proximal end being attached to at least one of the connectors and the distal end being attached to at least one of the anchors, and a delivery device being configured to removably seat at least one of the anchors on a distal end.
The present invention includes an anchor for use with the lung volume reduction device where the anchor comprises a central portion and an attachment portion connected to the central portion, the attachment portion being moveable between a reduced profile and an expanded profile, wherein when in the reduced profile the anchor is capable of being advanced into a passageway of the lung and when in the expanded profile the attachment portion attaches to the lung; and at least one cord having a distal end and a proximal end, the distal end being attached to the central portion of the anchor and the proximal end secured to the connector.
A variation of the invention includes an anchor comprising a wire where rotation of the anchor in a lung passageway permits ends of the wire to contact lung tissue causing the anchor to assume an expanded profile.
Another variation of the invention includes an anchor comprising a segment having a first and second end, wherein the central portion of the anchor is located between the first and second ends, the first end may be configured to be atraumatic and the second end may be configured to penetrate lung tissue, wherein rotation of said anchor in the lung passageway permits the ends to contact lung tissue causing the anchor to assume the expanded profile.
Another variation of the invention includes an anchor comprising a flat spring, the ends of the spring comprising the attachment portion, the spring folded about a center point, the fold forming the central portion of the anchor.
Another variation of the invention includes an anchor with an attachment portion comprising at least on

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