Method and device for simultaneously documenting and treating tension pneumothorax and/or hemothorax
Inventors
Assignees
Publication Number
US-12005165-B2
Publication Date
2024-06-11
Expiration Date
2033-08-07
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Abstract
A method and device are provided for simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothoraxA Veress-type needle portion includes a hollow needle for puncturing the chest wall over a blunt hollow probe biased by one or more springs to extend distally into the pleural cavity. Openings in the blunt hollow probe connect via a pathway to an automatic check valve, which permits the flow of air and/or fluid only in a proximal direction. Pressure from within the pleural cavity is transmitted to the interior surface of a pressure documenter. If pressure greater than atmospheric pressure is present in the pleural cavity, the pressure documenter will be automatically urged proximally to simultaneously allow air and/or fluid to escape from the pleural space through the device, thus treating the tension pneumothorax and/or hemothorax, as well as providing a stable indicator to positively document the diagnosis of increased pressure.
Core Innovation
The invention provides a method and device for the simultaneous or near-simultaneous documentation and treatment of tension pneumothorax and/or hemothorax. It features a Veress-type needle assembly with a hollow needle for penetrating the chest wall over a blunt hollow probe that is spring-biased to extend past the needle into the pleural cavity. The device includes openings in the blunt probe that connect to an automatic check valve, allowing air or fluid to exit only in a proximal direction, preventing entry of ambient air.
A key feature is the pressure indicator or documenter, which provides stable visual documentation of increased intrapleural pressure. If pressure in the pleural space is greater than atmospheric, the pressure indicator is automatically displaced and locked into position, confirming both the diagnosis of tension pneumothorax/hemothorax and the effective release of pressure. This allows medical personnel to easily observe whether increased pressure was present, aiding in both immediate and delayed clinical decision-making.
The invention addresses significant shortcomings of prior art, such as the risk of iatrogenic lung injury, need for multi-step procedures, and lack of documentation of diagnosis. The new device and method allow rapid, safe, and clear identification and relief of life-threatening tension in the pleural space, minimizing complications and supporting usage by personnel with minimal experience, including in out-of-hospital or battlefield conditions. This solution is specifically adapted to emergent scenarios lacking standard diagnostic tools.
Claims Coverage
There are two independent claims, each covering a core inventive feature of an assembly for inserting a medical device with a mechanism for automatic halting and stabilization during insertion.
Assembly with automatic mechanical locking to halt needle advancement upon probe return
The assembly comprises: - A housing with an open interior and both proximal and distal ends, with one or more openings. - A generally hollow elongate tubular member (needle) extending distally from the housing. - A probe slidably disposed within the hollow tube. - A biasing means that biases the distal end of the probe into a position distal to the distal end of the hollow tubular member, allowing force to move the probe proximally relative to the tube. - Mechanical locking means that automatically halt distal movement of the hollow tubular member in response to the distal end of the probe returning to a position distal to the distal end of the tubular member (such as after entering a body cavity).
Assembly with stabilizing device using locking mechanism to halt distal movement upon probe return
The assembly comprises: - A housing with an open interior, proximal and distal ends, and one or more openings. - A generally hollow elongate tubular member extending distally from the housing. - A probe slidably disposed within the tubular member. - A biasing member which biases the probe's distal end into a position distal to the distal end of the tubular member, and can be overcome by applied force. - A stabilizing device extending from the distal end of the housing, the device including a locking mechanism adapted to automatically halt distal movement of the hollow elongate tubular member and probe in response to the probe's distal end returning to its distal biased position (e.g., once inside a body cavity).
The claims broadly cover assemblies integrating a spring-biased probe within a hollow needle and incorporating mechanical locking or stabilizing means that automatically halt advancement upon entry into a body cavity, thereby facilitating safer, controlled insertion.
Stated Advantages
Substantially reduces the possibility of iatrogenic lung puncture during treatment.
Automatically prevents the introduction of air into the pleural space, reducing the risk of iatrogenic open pneumothorax.
Simultaneously or near-simultaneously documents and treats tension pneumothorax and/or hemothorax, providing immediate confirmation of diagnosis and treatment.
Provides a stable indicator for current and later medical personnel to positively document the presence or absence of increased pleural pressure.
Can be used rapidly and safely by out-of-hospital personnel with minimal experience and training, including in battlefield or mass casualty conditions.
Allows for empiric treatment based on risk group characteristics, lessening the risks to healthy lungs if overused in high-risk populations.
Easily secured to a patient to prevent dislodgement and to free the hands of medical personnel.
Easily manufactured, simple, inexpensive, and disposable.
Can be efficiently packaged, stored, and carried into environments lacking access to standard diagnostic means like x-ray or ultrasound.
Supports use in both adult and pediatric populations owing to availability of different sizes and adjustment features.
Documented Applications
Simultaneous or near-simultaneous diagnosis and treatment of tension pneumothorax and/or hemothorax in emergency medical situations.
Empiric preventive or therapeutic use in high-risk patients, including those undergoing hyperbaric treatment, environmental pressure changes (e.g., helicopter transport, plane flight), or specific procedures (e.g., bronchoscopy or lung biopsy).
Rapid out-of-hospital and battlefield treatment by personnel with minimal experience during mass casualty events.
In-hospital emergency use to provide immediate diagnosis and stabilization until definitive treatment such as thoracostomy can be performed.
Treatment within varied patient populations including adults, children, and infants based on appropriate device sizing.
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