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01/05/06 - USPTO Class 606 |  9 views | #20060004400 | Prev - Next | About this Page  606 rss/xml feed  monitor keywords

Method of treating a lung

USPTO Application #: 20060004400
Title: Method of treating a lung
Abstract: This invention provides methods for treating a lung, such as to treat a patient suffering from COPD. One aspect of the invention provides a method of treating a lung including the steps of: endotracheally delivering an expandable member (such as an inflatable member) to an air passageway of the lung with a delivery system; expanding the expandable member to make contact with a wall of the air passageway; and providing an open lumen through the expandable member to provide access to a portion of the lung distal to the expandable member. Some embodiments add the step of plugging the lumen, such as by contacting a plug with the expandable member or closing a port in the lumen. Some embodiments of the invention also include the step of reducing collateral flow around the expandable member and/or reducing collateral flow to lung regions distal to the expandable member, such as by delivering a collateral flow blocking agent, through the lumen. In some embodiments, the method includes the step of causing the portion of the lung distal to the expandable member to reduce volume, such as by compressing the lung portion. (end of abstract)



Agent: Wilson Sonsini Goodrich & Rosati - Palo Alto, CA, US
Inventors: Erin McGurk, Mark L. Mathis
USPTO Applicaton #: 20060004400 - Class: 606192000 (USPTO)

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

Method of treating a lung description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060004400, Method of treating a lung.

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 physiologic 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] This invention provides methods for treating a lung, such as to treat a patient suffering from COPD. One aspect of the invention provides a method of treating a lung including the steps of: endotracheally delivering an expandable member (such as an inflatable member) to an air passageway of the lung with a delivery system; expanding the expandable member to make contact with a wall of the air passageway; and providing an open lumen through the expandable member to provide access to a portion of the lung distal to the expandable member. Some embodiments add the step of detaching the expandable member from the delivery system. Some embodiments add the step of contracting the expandable member after the expanding step, such as by deflating the expandable member. In some embodiments, the expandable member is repositioned and reexpanded after the repositioning step.

[0016] Some embodiments add the step of plugging the lumen, such as by contacting a plug with the expandable member or closing a port in the lumen. Some embodiments include the step of unplugging the lumen, such as by moving a plug proximally or opening a port in the lumen.

[0017] In some embodiments, the method includes the step of detecting fluid flow around the expandable member and/or detecting collateral fluid flow to the lung region distal to the expandable member. The step of detecting collateral flow may include: sealing an air passageway in the lung at a point proximal to the expanding member; introducing a detectable gas into a region between the proximal point and the expanding member; and sensing for the presence of the detectable gas distal to the expanding member. In embodiments in which the expandable member is a first expandable member, the step of sealing the air passageway includes the step of sealing the air passageway with a second expandable member having an open lumen, and sensing comprises sampling for detectable gas through the second expandable member open lumen; with the method further including the step of detaching the second expandable member from a delivery system. In some embodiments, the method includes the step of deploying a plurality of expanding members to isolate the portion of the lung, with the sealing step including the step of sealing the air passageway at a point proximal to the plurality of expanding members. In some embodiments the sensing step may be performed at a proximal end of a device delivery catheter and/or may include sensing gas flowing through the open lumen in the expandable member.

[0018] Some embodiments of the invention include the step of reducing collateral flow around the expandable member and/or reducing collateral flow to lung regions distal to the expandable member, such as by delivering a collateral flow blocking agent through the lumen. The method may include the step of unplugging the lumen prior to the step of delivering a collateral flow blocking agent.

[0019] Some embodiments include the step of causing the portion of the lung distal to the expandable member to reduce volume, such as by compressing the lung portion. The method may also include the step of promoting adhesion of tissue within the lung portion, such as by introducing an adhesion inducing material into the lung portion.

[0020] In some embodiments, the method includes the step of permitting fluid to enter the lung portion when a difference between fluid pressure within the lung portion and fluid pressure in another portion of the lung exceeds about 2 mm Hg, about 10 mm Hg, about 20 mm Hg, or about 50 mm Hg.

INCORPORATION BY REFERENCE

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