Systems and methods for hemorrhage control and or tissue repair
Inventors
Gregory, Kenton W. • Bente, IV, Paul F. • Bryan, Heather Margaret • Lin, Jeffrey Yihyuan • Nuguid, Aileen • Pederson, Daniel Allen
Assignees
Providence Health System Oregon • HemCon Medical Technologies Inc
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Publication Number
US-9204957-B2
Publication Date
2015-12-08
Expiration Date
Abstract
A bandage application system of the present for hemorrhage control and/or tissue repair of the gastrointestinal tract, such as the gastrointestinal tract is provided. The system comprises a bandage for hemorrhage control and/or tissue repair of the gastrointestinal tract. It also includes an apparatus for introducing the bandage into a treatment area of the gastrointestinal tract requiring hemorrhage control and/or tissue repair, and for removing the apparatus from the treatment area without displacing the bandage from being adhered to the treatment area, and without damaging the gastrointestinal tract. Furthermore, it also has a device for adhering the bandage to the treatment area.
Core Innovation
A method controls bleeding and promotes hemostasis within a hollow body organ of a gastrointestinal tract selected from an esophagus, a stomach, a duodenum, a small intestine, and a large intestine by identifying within the hollow body organ a tissue treatment region requiring bleeding control. The method uses a layered bandage application system comprising a tubular bandage structure and a sleeve together with a hollow substantially cylindrical expandable body, and the tubular bandage structure comprises a chitosan material.
The hollow substantially cylindrical expandable body is sized and configured to expand between a collapsed condition having a first diameter approximating the normal interior diameter and an expanded condition having a second diameter greater than the first diameter. The bandage application system is provided in conjunction with a detachable endoscopic device, the sleeve is slid over the endoscopic device to allow viewing capability from an endoscopic device tip, and the hollow substantially cylindrical expandable body is slid over the sleeve in the collapsed condition.
After introducing the bandage application system and the endoscopic device into the hollow body organ, radial expansion force is applied by expanding the hollow substantially cylindrical expandable body from the collapsed condition to the expanded condition to radially enlarge and press the tubular bandage structure against all sides of the entire inner circumference of the tissue treatment region. The hollow substantially cylindrical expandable body is maintained in the expanded condition for a period of time sufficient to exert pressure so the radially enlarged tubular bandage structure adheres to all sides of the entire inner circumference, sealing the tissue treatment region and creating an active clotting surface.
The expandable body is then collapsed and removed without displacing the adhered and radially enlarged tubular bandage structure, and the radially enlarged tubular bandage structure defines a center hole through which food can pass. In one independent method, the bandage application system is pushed off the endoscopic device before adherence and the tubular bandage structure is then adhered by expansion of the hollow expandable body.
Claims Coverage
The document includes two independent methods directed to controlling gastrointestinal bleeding with a sleeve-delivered, hollow expandable body that radially expands and circumferentially adheres a chitosan tubular bandage to seal a tissue treatment region and create an active clotting surface while maintaining a center hole for food passage.
Circumferential radial expansion of a chitosan tubular bandage in a GI hollow organ
Radially enlarge a chitosan tubular bandage structure beyond a normal interior diameter by applying radial expansion force using a hollow substantially cylindrical expandable body, thereby pressing the tubular bandage structure against all sides of the entire inner circumference of a tissue treatment region within a gastrointestinal hollow body organ to seal the region and create an active clotting surface.
Endoscopic delivery with sleeve and hollow expandable body
Provide the bandage application system in conjunction with a detachable endoscopic device by sliding a sleeve over the endoscopic device for viewing capability from an endoscopic device tip, sliding the hollow substantially cylindrical expandable body over the sleeve in a collapsed condition, and introducing the bandage application system and the endoscopic device into the hollow body organ before applying radial expansion force.
Adhesion during expanded condition, then collapse removal without displacing the bandage
Maintain the hollow substantially cylindrical expandable body in the expanded condition for a period of time sufficient for the radially enlarged tubular bandage structure to adhere to all sides of the entire inner circumference, then release the radial expansion force by collapsing the hollow substantially cylindrical expandable body and removing it from the hollow body organ without displacing the adhered and radially enlarged tubular bandage structure.
Center hole for food passage through the gastrointestinal tract
Configure the radially enlarged tubular bandage structure to define a center hole through which food can pass through the gastrointestinal tract while sealing the tissue treatment region.
Pushing the bandage application system off the endoscopic device before adherence
Introduce the bandage application system into the hollow body organ, push the bandage application system off of the endoscopic device before adhering the tubular bandage structure to the tissue treatment region, and adhere the tubular bandage structure to the tissue treatment region by expanding a hollow expandable body to press the tubular bandage structure against all sides of the entire inner circumference to seal the tissue treatment region.
Across both independent methods, the core inventive coverage is the same: an endoscopic, sleeve-delivered chitosan tubular bandage is radially enlarged by a hollow substantially cylindrical expandable body to press circumferentially against the inner circumference of a GI tissue treatment region, adhere long enough to seal the region and create an active clotting surface, and then be removed while leaving the bandage in place with a center hole for food passage.
Stated Advantages
Controls bleeding by sealing the tissue treatment region.
Creates an active clotting surface.
Preserves food passage through the gastrointestinal tract via a center hole.
Documented Applications
Controlling gastrointestinal bleeding within a hollow body organ selected from an esophagus, a stomach, a duodenum, a small intestine, and a large intestine.
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