Pneumostoma management system packaging and kits

Abstract

A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The device is provided to patients in a sterile tray. The tray is efficiently packaged in order to supply a patient's needs for a period of time. Auxiliary and / or diagnostic materials can also be provided as part of the kit.

Description

CLAIM TO PRIORITY[0001]This application claims priority the following applications:[0002]U.S. Provisional Patent Application No. 61 / 408,852, filed Nov. 1, 2010, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM PACKAGING AND KITS” (Attorney Docket No. LUNG1-06024U50).[0003]The afore-mentioned application is incorporated herein by reference in its entirety.CROSS-REFERENCE TO RELATED APPLICATIONS[0004]This application is related to all of the following applications, and all the patent applications that claim priority thereto, including:[0005]U.S. patent application Ser. No. 12 / 388,447, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US1); and[0006]U.S. patent application Ser. No. 12 / 388,451, filed Feb. 18, 2009, entitled “PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US2); and[0007]U.S. patent application Ser. No...

AI Technical Summary

Benefits of technology

[0020]In view of the disadvantages of the state of the art, Applicants have developed a method for treating COPD in which an artificial passageway is made through the chest wall into the lung. An anastomosis is formed between the artificial passageway and the lung by creating a pleurodesis between the visceral and parietal membranes surrounding the passageway as it enters the lung. The pleurodesis prevents air from entering the pleural cavity and causing a pneumothorax (deflation of the lung due to air pressure in the pleural cavity). The pleurodesis is stabilized by a fibrotic healing response between the membranes. The artificial passageway through the chest wall also becomes epithelialized. The result is a stable artificial aperture through the chest wall which communicates with the parenchymal tissue of the lung.

[0021]The aperture into the lung through the chest wall is referred to herein as a pneumostoma. A pneumostoma provides an extra pathway that allows air to exit the lung while bypassing the natural airways which have been impaired by COPD and emphysema. By providing this ventilation bypass, the pneumostoma allows the stale air trapped in the lung to escape from the lung thereby shrinking the lung (reducing hyperinflation). By shrinking the lung, the ventilation bypass reduces breathing effort (reducing dyspnea), allows more fresh air to be drawn in through the natural airways and increases the effectiveness of all of the tissues of the lung for gas exchange. Increasing the effectiveness of gas exchange allows for increased absorption of oxygen into the bloodstream and also increased removal of carbon dioxide. Reducing the amount of carbon dioxide retained in the lung reduces hypercapnia which also reduces dyspnea. The pneumostoma thereby achieves the advantages of lung volume reduction surgery without surgically removing a portion of the lung or sealing off a portion of the lung.

Problems solved by technology

However, an additional ten million adults have evidence of impaired lung function indicating that COPD may be significantly underdiagnosed.

This increases the work of exhaling and leads to hyperinflation of the lung.

When the lungs become hyperinflated, forced expiration cannot reduce the residual volume of the lungs because the force exerted to empty the lungs collapses the small airways and blocks air from being exhaled.

With continued exposure to cigarettes or noxious particles, the disease progresses and individuals with COPD increasingly lose their ability to breathe.

Ultimately, severe emphysema may lead to severe dyspnea, severe limitation of daily activities, illness and death.

However, many patients are not candidates for such a taxing procedure.

However, these proposals remain significantly invasive and are still unproven.

None of the surgical approaches to treatment of COPD has been widely adopted.

Therefore, a large unmet need remains for a medical procedure that can sufficiently alleviate the debilitating effects of COPD and emphysema.

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