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12/29/05 - USPTO Class 606 |  88 views | #20050288702 | Prev - Next | About this Page  606 rss/xml feed  monitor keywords

Intra-bronchial lung volume reduction system

USPTO Application #: 20050288702
Title: Intra-bronchial lung volume reduction system
Abstract: The invention provides devices and systems for treating lungs. One aspect of the invention provides a lung device with an expandable member having an open lumen formed therethrough, the expandable (e.g., inflatable and compliant) member having an expanded diameter adapted to contact a circumferential wall portion of a lung air passageway. The device may also include a plug adapted to close the open lumen and a coupler adapted to couple the plug and the expandable member. Another aspect of the invention provides a lung device and delivery system including: an expandable member having an open lumen formed therethrough, the expandable member having an expanded diameter adapted to fit within a lung air passageway; and a delivery catheter adapted to deliver the expandable member to a lung air passageway, the delivery catheter having a coupler adapted to couple the catheter to the expandable member. (end of abstract)



Agent: Wilson Sonsini Goodrich & Rosati - Palo Alto, CA, US
Inventors: Erin McGurk, Mark L. Mathis, David P. Thompson, Nathan A. Aronson
USPTO Applicaton #: 20050288702 - Class: 606192000 (USPTO)

Related Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator), Inflatable Or Expandible By Fluid

Intra-bronchial lung volume reduction system description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20050288702, Intra-bronchial lung volume reduction system.

Brief Patent Description - Full Patent Description - Patent Application Claims
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CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 60/580,565, filed Jun. 16, 2004, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] The primary role of the lung is to perform the function of breathing which assists in the intake of oxygen and removal of carbon dioxide from the body. The oxygen in air is inhaled through the mouth and trachea to the main bronchi. The bronchi divide at the end of the trachea into the left and right main bronchi and these respectively divide into bronchial branches, which "feed" the three lobes of the lung on the right and two on the left. These bronchi continue to subdivide into bronchioles (smaller bronchi), over twenty three times in total. The over 100,000 bronchioles get smaller in diameter and ultimately terminate in over 300 million air sacs, called alveoli. The alveoli, which are clustered like grapes, are approximately 0.3 mm in diameter and provide a huge surface area for gas exchange to take place. There are capillaries surrounding the alveoli and this is where the inspired oxygen is diffused into the vascular system of the body. Likewise, toxic CO.sub.2 is diffused into the alveoli from the capillaries and is removed from the body during expiration.

[0003] With no external loads, the lung structure is approximately the size of a grapefruit. It is expanded larger in the chest cavity with a physiologic level of vacuum that stretches it to the chest wall. As we inhale, we are forcing the lung cavity to a larger condition by flexing the ribs and lowering the diaphragm. The vacuum around the lungs pull the lung volume larger as the chest volume is increased; air pressure in the lung is reduced and atmospheric air pressure forces air into the lung. During expiration, the diaphragm and ribs are relaxed to allow the elastic properties of the lung to pull the chest cavity to a smaller volume and to force air out of the lungs.

[0004] Chronic Obstructive Pulmonary Disease ("COPD") is a progressive disease that causes lung parenchyma to lose elastic properties and lose surface area that is required to exchange gas such as O.sub.2 and CO.sub.2. Lung tissue is eroded to leave large holes, typically in the upper lobes. The holes do not contribute to the elastic pulling forces required during expiration. Areas adjacent to the holes are more highly stressed. The stressed tissue stretches and loses recoil properties. These stretched regions fail to pull on and thus fail to suspend the major airways in a radial fashion to hold them open. As the disease progresses, the patient will eventually need to force expiration, which causes the major airways to collapse and block air flow. This effect is exacerbated with additional applied expiration pressure since the airways are ill-supported. During inspiration, these unsupported regions fill preferentially since they are floppy and have no resistance to expand (no elasticity). They preferentially consume the oxygenated air even though there is little remaining surface area to exchange O.sub.2 to the bloodstream.

[0005] Normal lungs rarely present with collateral flow paths between lobules and between major lobes of the lung in the form of pores and leak paths. In COPD patients, damaged tissue forms vacuoles or holes, which grow in size (e.g., 2 .mu.m to over 500 .mu.m) and multiply to allow flow from numerous airway paths to supply these regions with air. As this tissue degradation occurs, numerous holes communicate with each other, and eventually the lobes communicate with each other, through means other than the normal airways.

[0006] Lung volume reduction surgery (LVRS) is a procedure where the chest is opened and a target region of lung is cut out. This accomplishes several things. It removes damaged regions that contribute very little to gas exchange. More importantly, it removes lung volume so that the healthy portion of the lung that remains can be expanded beyond typical physiolgic volume (expand healthy functioning alveoli) to fill the chest cavity with functioning lung. The procedure increases surface area of healthy tissue to increase gas exchange. It also stretches the remaining tissue to restore support of the major airways, and it improves expiration mechanics. The procedure also cuts off blood circulation through the removed regions that had little effective gas exchange. This prevents CO.sub.2 laden blood from mixing back into the left side of the heart and to the arteries.

[0007] While the LVRS procedure is ideal in many ways, it requires major chest intervention that requires cutting the chest plate or major spreading of ribs. Pain associated with this causes interruption of normal breathing and difficulty to revive the patient from forced ventilation to normal breathing after the procedure. The procedure presents with high mortality rates and long recovery times.

[0008] Another risk with LVRS is associated with cutting too much volume out. By cutting more than approximately one third of the expanded lung volume per side (one third of the chest cavity volume per side), the tissue may be over-stressed and rupture with expansion. These ruptures culminate as spontaneous pneumothorax events (leaks that vent vacuum holding the lung up to the chest wall and allow collapse of the lung). Also, adhesions between the lung and chest wall that occur naturally present stress points upon expansion that can cause ruptures.

[0009] Tension pneumothorax complications can also be caused by the surgery. This is a condition that causes central chest organs to shift. The imbalance of force in the chest after expanding highly elastic lung tissue pulls the mediastinal region of the central thorax sufficiently to actually shift large vessels and cause flow restrictions. This condition can be very serious and warrant further surgeries.

[0010] If lung volume reduction ("LVR") could be accomplished less invasively, the complications and morbidity associated with the surgery could be nearly eliminated. In addition, the procedure would be open to many more patients who might not be able to or not desire to undergo a major thoracic surgical procedure. Current less invasive approaches to LVR have met with limited success, however.

[0011] Bronchoscopically-placed LVR devices have been described which may be implanted into the lungs to block airways in an attempt to create a volume reduction effect distal to the blocking device to emulate LVRS. For example, plug and one-way air directing devices are introduced to block an area of the lung to cause oxygen depletion distally to cause volume reduction through a process known as atelectasis. These devices may provide some relief to the patient by blocking preferential filling of damaged lung tissue. All of these devices are inserted through the working channel of a flexible bronchoscope and are placed only as far as the third to the fifth subdivision or segment of bronchi.

[0012] However, there are several problems with these earlier devices as they are currently used. Current blocking devices do not facilitate access to distal regions of the lung after deployment to allow for reoccurring interventions or treatments.

[0013] In addition, current bronchoscope working channels are typically 2.0 mm in diameter; the blocking and one-way valve devices must be expanded to seat in airways that are as large as 15 mm in diameter. Therefore, the expansion ratio for these devices needs to sometimes be as high as 750%. Covered devices that are stretched to this extent are typically not robust air leak seals. Current devices are made small enough to fit down the working channel of the bronchoscope so they can be pushed out to self deploy. The devices are typically made of Nitinol alloys with long elastic range that drives recovery to an expanded state. This also requires that the device be scaled down to such a small diameter profile that the self expansion forces are extremely low to anchor the device and the covering materials must be thin and therefore fragile.

[0014] Moreover, these devices block air from flowing in the major airways but are not effective if collateral flow paths exist. The collateral paths allow the distal region to fill and hyper-inflate. When collateral flow is not an issue, these devices block O.sub.2 and CO.sub.2 exchange, and yet the blood flow in the region still carries CO.sub.2 laden blood through the lungs to mix with systemic blood flow. Finally, uncontrolled atelectasis beyond a one third volume reduction may cause tension pneumothorax complications and stress ruptures within the lung wall, causing lung collapse.

SUMMARY OF THE INVENTION

[0015] The invention provides devices and systems for treating lungs. One aspect of the invention provides a lung device with an expandable member having an open lumen formed therethrough, the expandable (e.g., inflatable and compliant) member having an expanded diameter adapted to contact a circumferential wall portion of a lung air passageway. The device may also include a plug adapted to close the open lumen and a coupler adapted to couple the plug and the expandable member. In some embodiments, the device may also include a pressure release valve (possibly in the plug) adapted to permit fluid flow from a first point in the air passageway proximal to the device to a second point distal to the device when a pressure difference between the first point and the second point exceeds a pressure relief amount. The device may also have a coupler adapted to attach the device to a delivery system.

[0016] Another aspect of the invention provides a lung device and delivery system including: an expandable member having an open lumen formed therethrough, the expandable member having an expanded diameter adapted to fit within a lung air passageway; and a delivery catheter adapted to deliver the expandable member to a lung air passageway, the delivery catheter having a coupler adapted to couple the catheter to the expandable member. In embodiments in which the expandable member is inflatable, the system may also include an inflation lumen (such as in an inflation catheter) adapted to inflate the inflatable member and a deflation lumen (such as in a deflation catheter) adapted to deflate the inflatable member. In some embodiments, the deflation catheter may be further adapted to reposition the inflatable member after deflation of the inflatable member.

[0017] In some embodiments, the coupler has a disengagement mechanism adapted to permit the catheter to disengage from an expandable member when the expandable member is implanted in a lung. The system may also include a plug adapted to be added to close the open lumen, the system being further adapted to deliver the plug to the expandable member within the air passageway, such as by use of a plug delivery catheter. The system may also include a device adapted to removed the plug from the open lumen such as by using, e.g., a coupler adapted to releasably engage the plug and the expandable member.

[0018] In some embodiments, the system includes a collateral flow detector adapted to detect collateral flow around the expandable member when the expandable member is expanded within the air passageway. The collateral flow detector may include an expandable seal. The system may also include a collateral flow reduction mechanism adapted to reduce collateral flow around the expandable member--or in lung regions distal to the expandable member--when the expandable member is expanded within the air passageway. The collateral flow reduction mechanism may include a source of collateral flow reduction agent and a collateral flow reduction agent delivery mechanism.

[0019] Yet another aspect of the invention provides a lung device including a member having an open lumen formed therethrough, the member having an diameter adapted to contact a circumferential wall portion of a lung air passageway.

INCORPORATION BY REFERENCE

[0020] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

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