Patent Application
20200390537
Persistent air leaks are a cause of significant morbidity in patients who have undergone lung surgery and those with significant parenchymal lung disease or suffering from a pneumothorax. Although most air leaks resolve spontaneously with conservative management, some leaks are prolonged and contribute to significant morbidity. When a persistent air leak will not resolve, practitioners have long resorted to surgical management and chemical pleurodesis as the usual treatments for persistent air leaks. Although surgery is an effective means of treating persistent air leaks with relatively low mortality, resulting morbidity is much higher. There exists a need for less morbid treatment options as well as options for patients who are not operable.
Accordingly, there exists a need for an effective alternative for treating persistent air leaks, and in particular an apparatus and method of using the apparatus that can be customized to the patient's individual needs such that all patients can benefit.
The present disclosure includes disclosure of an endobronchial blocker for treatment of a persistent air leak and method of using the same. In at least one embodiment, such an endobronchial blocker comprises a perimeter wall with an exterior surface and an interior surface and enclosing a hollow internal cavity; an open end comprising a rim defining an opening to the hollow internal cavity; a closed end opposite the open end, airtightly arranged with the perimeter wall being so as to obstruct airflow into and out of the hollow internal cavity; and one or more friction enhancing elements on the exterior surface of the perimeter wall. In an aspect of such an embodiment, the perimeter wall comprises a flexible biocompatible material. In a further aspect of such an embodiment, the flexible biocompatible material comprises an implant-grade silicone. In an aspect of such an embodiment, at least one physical characteristic of the perimeter wall is selected as a result of a patient's pre-procedural testing. In a further aspect of such an embodiment, the physical characteristic is selected from the group consisting of width, length, shape, and wall thickness. In an aspect of such an embodiment, the perimeter wall is cylindrical. In an aspect of such an embodiment, the perimeter wall is hour glass shaped. In an aspect of such an embodiment, the perimeter wall further comprises at least one branch. In an aspect of such an embodiment, the friction enhancing elements comprise a plurality of studs distributed on the exterior surface.
In at least one embodiment, such a method of treating a persistent air leak by inserting an endobronchial blocker comprises the steps of selecting a site for placement of said endobronchial blocker to treat a patient's persistent air leak by identifying an airway or a bronchus leading to said persistent air leak, and measuring at least one physical characteristic of said airway, said bronchus, or said persistent air leak; providing an endobronchial blocker, the endobronchial blocker comprising: a perimeter wall with an exterior surface and an interior surface and enclosing a hollow internal cavity, an open end, comprising a rim defining an opening to the hollow internal cavity, a closed end opposite the open end, airtightly arranged with the perimeter wall being so as to obstruct airflow into and out of the hollow internal cavity; and one or more friction enhancing elements on the exterior surface of the perimeter wall; loading the endobronchial blocker into a bronchoscope; inserting the bronchoscope into the patient's upper airway; maneuvering the bronchoscope to location of the bronchus or airway selected for placement of the endobronchial blocker; releasing the endobronchial blocker from the bronchoscope in position to occlude the persistent air leak; monitoring clinical measurements to ensure the endobronchial blocker has reduced or eliminated said persistent air leak; and securing the endobronchial blocker in the patient's airway. In an aspect of such an embodiment, the perimeter wall comprises a flexible biocompatible material. In a further aspect of such an embodiment, the flexible biocompatible material comprises an implant-grade silicone. In an aspect of such an embodiment, at least one physical characteristic of the perimeter wall is selected as a result of a patient's pre-procedural testing. In a further aspect of such an embodiment, the physical characteristic is selected from the group consisting of width, length, shape, and wall thickness. In an aspect of such an embodiment, the perimeter wall is cylindrical. In an aspect of such an embodiment, the perimeter wall is hour glass shaped. In an aspect of such an embodiment, the perimeter wall further comprises at least one branch. In an aspect of such an embodiment, the friction enhancing elements comprise a plurality of studs distributed on the exterior surface. In an aspect of such an embodiment, the persistent air leak is caused by a fistula. In an aspect of such an embodiment, the bronchoscope comprises a rigid bronchoscope.
The embodiments and other features, advantages and disclosures contained herein, and the manner of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.
As shown in
The size and shape of the endobronchial blocker 10 according to the present disclosure are based upon the size, shape, and location of patient's fistula, as well as the size and shape of the airway or bronchus leading to the fistula. In at least one embodiment, the size and shape of the endobronchial blocker 10 according to the present disclosure may be chosen based upon the results of pre-procedural measurements. That is, an endobronchial blocker 10 according to the present disclosure can be customized with regard to size, shape, width, wall thickness, and length, in order to substantially match the conditions of the patient's fistula, and airway or bronchus.
While this disclosure has been described as having various embodiments, these embodiments according to the present disclosure can be further modified within the scope and spirit of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. For example, any methods disclosed herein represent one possible sequence of performing the steps thereof. A practitioner may determine in a particular implementation that a plurality of steps of one or more of the disclosed methods may be combinable, or that a different sequence of steps may be employed to accomplish the same results. Each such implementation falls within the scope of the present disclosure as disclosed herein and in the appended claims. Furthermore, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains.
