Method and device for simultaneously documenting and treating tension pneumothorax and/or hemothorax
Inventors
Assignees
Publication Number
US-11364326-B2
Publication Date
2022-06-21
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 present invention provides a method and device for simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothorax. The device features a Veress-type needle assembly, which includes a hollow needle for puncturing the chest wall, a blunt hollow probe biased by one or more springs to extend distally into the pleural cavity, and an automatic check valve that only permits the flow of air and/or fluid in a proximal direction. Openings in the blunt probe connect the pleural cavity via the pathway to the check valve and through to a pressure indicator.
A key innovation is that, upon insertion into the pleural cavity, if pressure greater than atmospheric pressure is present (indicating tension), the internal pressure causes the pressure indicator to automatically document this by being urged proximally, while simultaneously allowing trapped air and/or fluid to escape via the device, immediately treating the tension. This indicator provides a stable visual confirmation for current and later caregivers that increased pressure was present, documenting the diagnosis and confirming the intervention. If no elevated pressure is present, the indicator remains unchanged, showing that tension was not detected.
The problem addressed by this invention is that early diagnosis and rapid treatment of tension pneumothorax and/or hemothorax are critical, but current diagnostic and therapeutic tools are limited, especially in emergency or out-of-hospital settings. Traditional needle decompression methods have significant disadvantages, such as risk of lung or heart injury, creating an open pneumothorax, lack of diagnostic documentation, and requiring multiple steps or additional procedures. The present invention overcomes these limitations by providing a single-step, safe, and reliable device that both treats and documents the presence of tension, minimizing risk to patients, particularly in high-risk or resource-poor environments.
Claims Coverage
There is one independent claim in this patent that outlines several inventive features.
Assembly with Veress-type needle, biasing, and mechanical locking to place a catheter
The assembly consists of: - A housing with proximal and distal ends, with one or more openings, and an open interior. - A generally hollow needle with a sharp distal end, extending distally from the housing. - A probe slidably disposed within the needle, having a blunt distal end. - Means for biasing the blunt distal end of the probe so it normally rests distal to the sharp distal end of the needle, but can be moved proximally by an applied force. - Mechanical locking means that automatically halt the distal movement of the needle and probe when the blunt distal end returns to the position distal to the sharp end upon entering a body cavity. - A catheter disposable over the needle, configured for insertion into the body cavity with the needle.
The inventive features specify a safety-focused needle assembly with a biased blunt probe, automatic mechanical locking, and integrated catheter delivery for safe and effective access to body cavities.
Stated Advantages
Provides simultaneous or near-simultaneous documentation and treatment of tension pneumothorax and/or hemothorax, improving diagnosis and therapy in high-risk patients.
Reduces risk of iatrogenic lung or heart injury due to the Veress-type blunt probe and mechanical safety features.
Allows for empirical treatment in at-risk populations without relying on classic diagnostic tools or physical findings.
Stably documents successful treatment and presence or absence of tension pneumothorax and/or hemothorax, aiding immediate and later clinical decision-making.
Prevents introduction of air into the pleural space through use of an automatic check valve, thereby inhibiting iatrogenic open pneumothorax.
Can be easily used by personnel with minimal training in both in-hospital and out-of-hospital settings, including under battlefield and mass casualty conditions.
Device is designed to be inexpensive, disposable, sterile, and easily manufactured and transported.
Device includes means for secure attachment to the patient to reduce risk of dislodgement during transport.
Device can be manufactured in various sizes for use in adults, children, and infants, and can be adjusted for proper sizing based on patient group.
Lumen is designed not to kink or be easily sealed during transport, preventing occult tension pneumothorax.
May provide a single-step treatment without the need for further invasive procedures if no tension is detected.
Documented Applications
Treatment and documentation of tension pneumothorax and/or hemothorax in humans and animals.
Use by in-hospital and out-of-hospital personnel for emergency intervention in settings lacking standard diagnostic tools (e.g., battlefield, mass casualty, ambulance, rural healthcare).
Prevention and/or treatment of tension pneumothorax and/or hemothorax in high-risk patients, such as those undergoing hyperbaric treatment, environmental pressure changes (helicopter, plane flights), or specific procedures (bronchoscopy, lung biopsy).
Medical procedures for draining air and/or fluid or placing a catheter into body cavities, hollow organs, vessels, or other potential spaces, including but not limited to thoracentesis, thoracostomy, paracentesis, arthrocentesis, tracheostomy, laparoscopy, laparotomy, lumbar puncture, cricothyroidotomy, abscess drainage and/or empyema drainage, central/peripheral venous or arterial catheter placement, and ventriculostomy.
Use of catheters such as Penrose drain, pigtail catheter, chest tube, tracheostomy tube, endotracheal tube, venous or arterial catheter, thoracentesis tube, paracentesis tube, abscess drainage tube, or other medical tubes for placement into a body cavity.
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