Method and device for simultaneously documenting and treating tension pneumothorax and/or hemothorax
Inventors
Assignees
Publication Number
US-9616203-B2
Publication Date
2017-04-11
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 simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothorax. The device centers on a Veress-type needle assembly comprising a hollow needle for puncturing the chest wall, a blunt hollow probe biased by a spring to extend past the needle for safe entry into the pleural cavity, an automatic check valve, and a pressure indicator. The openings in the blunt probe connect to a pathway that only allows proximal flow via the automatic check valve, preventing air or fluid from entering the pleural space distally.
Upon insertion into the pleural cavity, if the internal pressure is greater than atmospheric pressure, this pressure is transmitted to a pressure documenter mechanism which provides a stable and visible indicator of increased pressure. This configuration allows air or fluid to escape from the pleural space through the device, treating the condition while simultaneously documenting the diagnosis by mechanical indication, visible to current and later caregivers.
The problem addressed is the lack of emergency devices and methods that can both safely treat and reliably document the presence of tension pneumothorax and/or hemothorax, particularly in environments where diagnostic imaging is unavailable. Current methods carry risks such as iatrogenic organ injury, introduction of air, or lack of documentation, leading to potential unnecessary invasive follow-up procedures or mismanagement. The invention reduces these risks by integrating a safety-biased needle, automatic check valve, and pressure indicator in one assembly, providing immediate treatment and objective, stable diagnostic evidence.
Claims Coverage
The patent contains one independent claim outlining five main inventive features, supported by dependent claims that further specify aspects of the assembly.
Veress-type needle assembly with a blunt probe and spring bias
The assembly includes: - A housing with an open interior and one or more openings at the proximal and distal ends. - A generally hollow needle extending from the housing, ending with a sharp distal tip. - A probe slidably disposed within the hollow needle, featuring a blunt distal end and at least one opening near the blunt tip. - Means for biasing (such as a spring) the blunt distal end of the probe to extend past the sharp needle tip, which can be overcome by force so the probe moves proximally relative to the needle.
Mechanical locking mechanism for halting needle and probe movement
A mechanical locking means is provided for automatically stopping distal movement of the needle and probe once the blunt distal end of the probe returns to its distal position (i.e., past the sharp needle tip) after the needle enters the body cavity. This feature is activated by the probe's relative movement as it enters the body cavity.
Proximal flow pathway for gas and/or fluid release
The assembly has means for permitting gas and/or fluid to flow proximally through the device. This includes flow through the probe’s distal opening, through the hollow interior of the probe, into the housing's open interior, and out through the housing openings into the external environment.
Prevention of distal flow into the patient
The device features means for preventing gas and/or fluid from passing distally from the environment back through the hollow needle into the patient, such as an automatic check valve or equivalent mechanism.
Stable visual indication of gas or fluid passage
A means is included to provide a stable, visible indication that gas and/or fluid has passed proximally through the device, from the probe’s distal end, out of the housing openings, and into the environment. This indicates the release or presence of positive pressure in the cavity after decompression.
The inventive assembly integrates a safety-biased Veress needle, automatic check valve for one-way proximal flow, mechanical locking for precise placement, and a stable pressure indicator to both treat and document tension pneumothorax and/or hemothorax.
Stated Advantages
Simultaneously or near-simultaneously documents and treats tension pneumothorax and/or hemothorax, improving emergency response.
Reduces the risk of iatrogenic lung and heart injury by using a spring-biased blunt probe and safety mechanisms.
Minimizes the risk of introducing air into the pleural space by utilizing an automatic check valve that permits only proximal flow.
Provides a stable, visible indicator for positive diagnosis, allowing later caregivers to confirm the presence or absence of tension pneumothorax and/or hemothorax.
Allows empiric treatment in high-risk populations with minimal chance of injury to healthy lungs.
Can be utilized by out-of-hospital personnel with minimal experience, including under battlefield and mass casualty conditions.
Provides an easily secured device to the patient, freeing hands for medical care and preventing device dislodgement.
Device lumens are designed to avoid kinking or blockage during patient transport, reducing risk of occult tension pneumothorax.
Devices are low-cost, disposable, and simple to manufacture, supporting efficient supply and rapid use.
Documented Applications
Treatment and documentation of tension pneumothorax and/or hemothorax in humans, including adults, children, and infants.
Use by out-of-hospital personnel, such as in battlefield, mass casualty conditions, or environments lacking diagnostic imaging.
Use by in-hospital personnel for immediate diagnosis and stabilization, pending definitive treatment like thoracostomy.
Prophylactic insertion in high-risk patients undergoing procedures or conditions likely to precipitate tension pneumothorax and/or hemothorax (e.g., hyperbaric treatment, mechanical ventilation, changes in environmental pressure, bronchoscopy, lung biopsy).
Potential use in other body cavities and medical procedures, including thoracentesis, thoracostomy, paracentesis, arthrocentesis, tracheostomy, laparoscopy, laparotomy, lumbar puncture, cricothyroidotomy, abscess and empyema drainage, central and peripheral venous or arterial catheter placement, ventriculostomy, and similar interventions.
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