Fluoroscopy-independent balloon guided occlusion catheter and methods
Inventors
Assignees
Publication Number
US-9474882-B2
Publication Date
2016-10-25
Expiration Date
2033-02-26
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Abstract
A system for deploying and selectively inflating a balloon at a desired location, without the aid of fluoroscopy is described.
Core Innovation
The invention provides an endovascular occlusion system and kit capable of selectively deploying and inflating a balloon at a desired location within a major vessel, such as the thoracic aorta, without the need for fluoroscopy. This system includes an endovascular wire or catheter with a curved distal tip (such as a J-tip), one or more lumens for balloon inflation and pressure sensing, pre-calibrated length markers, a distal pressure sensor port, a hypotube, and a multi-port and valve assembly. The placement of the system is guided based on a nomogram that correlates external anatomical landmarks to internal vascular distances, enabling fluoroscopy-independent operation.
The problem addressed is the lack of effective, minimally invasive solutions for rapid hemorrhage control in non-compressible torso vascular injuries, which are a leading cause of preventable death in military and civilian trauma settings. Current methods, like emergency thoracotomy with aortic clamping, are invasive, require specialized equipment and personnel, and have poor survival rates. Additionally, existing balloon occlusion systems require large sheaths, fluoroscopy for placement and inflation, and do not address the specific anatomic and procedural needs encountered in younger trauma populations or austere environments.
The disclosed system utilizes external body measurements to determine vascular insertion distances, allowing precise, rapid, and safe insertion and positioning of the occlusion balloon using only physical anatomical landmarks, pre-calibrated catheter markers, and the correlated nomogram or tables. The system can be introduced through a relatively small percutaneous sheath, is designed with features such as self-centering struts or guide balloons to maintain vessel path integrity, and incorporates pressure monitoring to avoid over-inflation, enhancing procedural safety and reliability outside traditional, fluoroscopy-equipped environments.
Claims Coverage
There are two independent claims detailing the inventive features of the endovascular occlusion system and kit, comprising a total of several main inventive features.
Fluoroscopy-independent occlusion catheter system
An endovascular occlusion system comprising: - A catheter member with proximal and distal sections, plural lumens running longitudinally, and a main diameter. - An occlusion balloon connected to the catheter member and in fluid communication with one lumen. - A curved distal tip at the catheter's leading end, with a shaft between the balloon and the tip's curved portion, the latter preventing departure from the vessel path as the device is advanced. - The curved portion of the distal tip is sufficiently flexible to straighten from its curved configuration. - A distal pressure sensor port located between the balloon and distal tip, in communication with a pressure lumen. - A hypotube running parallel to the catheter axis within the member, itself having a lumen. - A multi-port and valve assembly in fluid communication with the proximal end of a pressure sensor lumen.
Endovascular occlusion kit with anatomical landmark-based guidance
An endovascular occlusion kit comprising: - A catheter member with proximal and distal sections and plural lumens running longitudinally. - A curved distal tip at the leading end, with the occlusion balloon positioned proximally to the tip; the tip includes a shaft and a curved portion designed to prevent vessel path departure, with the curved portion being sufficiently flexible to straighten. - The occlusion balloon is connected to the catheter and in fluid communication with a designated lumen. - A distal pressure sensor port between the balloon and tip, communicating with a pressure lumen. - A hypotube extending parallel to the longitudinal axis within the catheter. - A multi-port and valve assembly at the pressure sensor lumen’s proximal end. - Annotated markings on the proximal section, with a nomogram that correlates distances between identifiable anatomical landmarks to determine the insertion distance. - An inflator in communication with an inflation fluid source and the occlusion balloon.
The inventive features cover a fluoroscopy-independent occlusion catheter system and kit that enables precise balloon positioning through anatomical landmark correlation, includes pressure monitoring, and employs innovative design elements for secure and safe vessel occlusion.
Stated Advantages
Enables rapid and accurate placement of an occlusion balloon in the thoracic aorta without the need for fluoroscopy.
Provides a less invasive and viable alternative to open thoracotomy for resuscitative aortic occlusion.
Facilitates use in emergency, battlefield, or resource-limited settings where fluoroscopy is unavailable.
Allows for augmentation of heart and brain perfusion during hemorrhagic or shock states, supporting vital functions while corrective actions are performed.
Reduces dependency on large, inflexible, and fluoroscopy-dependent balloon systems not suited for young adult trauma populations.
Improves safety by incorporating pre-calibrated length markers and a nomogram for guided, fluoroscopy-free insertion.
Documented Applications
Emergency treatment of non-compressible torso hemorrhage in trauma patients in both civilian and military settings.
Use in cardiogenic shock, neurogenic shock, and post-partum hemorrhage in operating or delivery rooms.
Application in wide margin endovascular procedures such as positioning of occlusion balloons to control torso hemorrhage.
Deployment in environments lacking fluoroscopy, such as forward surgical hospitals near battlefields, resuscitation rooms, or out-of-hospital trauma locations.
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