Hemostatic system for body cavities

Abstract

Bleeding is controlled on an inner surface of a body cavity by inserting into the cavity an expandable balloon which is covered by a hemostatic shroud, expanding the balloon, and compressing the shroud against the site of bleeding. The balloon may be disposed around a central tube to supply inflation medium. The tip of the device is soft to aid with insertion. The invention includes the corresponding devices and systems for such control of bleeding within a body cavity or passageway, as well as a method of making the devices.

Description

[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09 / 921,864 filed Aug. 10, 2001, which in turn is a continuation-in-part of U.S. patent application Ser. No. 09 / 406,166 filed Sep. 27, 1999, which in turn is a continuation-in-part of U.S. patent application Ser. No. 09 / 057,414, filed on Apr. 8, 1998.TECHNICAL FIELD [0002] This invention relates generally to medical devices and methods of use, and more specifically, to materials, apparatus, and methods for facilitating hemostasis within a body cavity or passageway. BACKGROUND OF THE INVENTION [0003] Nasal passageways, for example, are often susceptible to uncontrolled bleeding caused by various forms of trauma, disease or cellular dysfunction. Methods and devices for controlling, limiting or stopping such bleeding would be useful in a variety of situations, ranging from emergency room care to long term care. [0004] Bleeding is typical after nasal related surgeries or procedures, and epistaxis relate...

AI Technical Summary

Benefits of technology

[0005] The present invention comprises methods and devices for the control of bleeding from an inner wall of a body passageway or cavity. Briefly, the invention comprises an inflatable, expandable balloon, usually covered by a hemostatic shroud, which is inserted into a body cavity, such as a nasal passageway. The shroud is composed of a hemostatic agent; that is, the shroud acts to facilitate or enhance blood clot formation. The balloon component of the present invention is expanded, or inflated, within the cavity in order to press the shroud against the site of bleeding, thereby allowing it to absorb blood and facilitate hemostasis. In specific embodiments, the shroud is composed of a woven or knitted fabric of a hemostatic fiber (such as carboxymethylcellulose) or a reinforced hemostatic fiber. Optionally, this shroud may include an “extension” or “tail” fiber, which upon balloon deflation and removal, facilitates the later removal of the shroud which has been intentionally left in vivo.

[0007] A particular embodiment of the invention comprises a device for insertion of a shrouded balloon into a nasal passageway by a catheter configured such that the balloon encircles the catheter tube. The lumen of the catheter tube thereby serves as a passageway for breathing. The inflated balloon compresses the shroud against the bleeding nasal wall, thereby facilitating or enhancing hemostasis. The balloon is deflatable such that, upon balloon deflation, the shroud may be left in place on the cavity wall and may be removed at a later time, such as by an attached extension on the shroud.

[0008] In another embodiment, there is no central lumen. This gives the catheter a much smaller overall diameter. In patients with small nasal cavities, the lack of the breathing passageway is more than compensated for by the small profile which is far less traumatic and painful during insertion.

Problems solved by technology

Nasal passageways, for example, are often susceptible to uncontrolled bleeding caused by various forms of trauma, disease or cellular dysfunction.

Bleeding is typical after nasal related surgeries or procedures, and epistaxis related to a patient's nasal passageway can be difficult to control.

Insertion, application, and subsequent removal of these materials, however, can be difficult in small body passageways, such as nasal cavities.

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