Percutaneous single-phase surgical procedure for creating a pneumostoma to treat chronic obstructive pulmonary disease

Abstract

A percutaneous single-phase surgical procedure is disclosed for creating a pneumostoma to treat chronic obstructive pulmonary disease. A pneumostomy instrument is introduced percutaneously through the thoracic wall, parietal membrane, visceral membrane and into the parenchymal tissue of the lung. The pneumostomy instrument crosses the pleural cavity between the parietal membrane and visceral membrane there being no pleurodesis between the membranes prior to passage of the pneumostomy instrument. A pneumoplasty device at the distal end of the pneumostomy instrument displaces and engages the parenchymal tissue of the lung and the pneumostomy instrument is used to secure the lung and visceral membrane in contact with the parietal membrane and chest wall. The pneumostomy instrument is left in place while a pneumostoma tract heals and pleurodesis occurs between the pleural membranes surrounding the pneumostomy instrument.

Description

CLAIM TO PRIORITY[0001]This application claims priority to all of the following applications including: U.S. Provisional Application No. 61 / 029,830, filed Feb. 19, 2008, entitled “ENHANCED PNEUMOSTOMA MANAGEMENT DEVICE AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06013US0);[0002]U.S. Provisional Application No. 61 / 032,877, filed Feb. 29, 2008, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06001US0);[0003]U.S. Provisional Application No. 61 / 038,371, filed Mar. 20, 2008, entitled “SURGICAL PROCEDURE AND INSTRUMENT TO CREATE A PNEUMOSTOMA AND TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE” (Attorney Docket No. LUNG1-06000US0);[0004]U.S. Provisional Application No. 61 / 082,892, filed Jul. 23, 2008, entitled “PNEUMOSTOMA MANAGEMENT SYSTEM HAVING A COSMETIC AND / OR PROTECTIVE COVER” (Attorney Docket No. LUNG1-06008US0);[0005]U.S. Provisional Application No....

AI Technical Summary

Benefits of technology

[0036]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 seal, adhesion and / or pleurodesis between the visceral and parietal membranes surrounding the passageway as it enters the lung. The seal, adhesion and / or pleurodesis prevent 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.

[0037]The artificial 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 from the bloodstream. 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.

[0041]In accordance with one embodiment, the present invention provides an accelerated two-phase pneumostomy technique in which a pleurodesis is created acutely at the first phase of a procedure and a pneumostoma is created as a second phase of the same procedure after creation of the pleurodesis.

[0043]In accordance with specific embodiments, the present invention provides minimally-invasive approaches for performing a pneumostomy.

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 in clinical trails in 2008.

None of the surgical approaches to treatment of COPD is widely accepted.

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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