Percutaneous access pathway system and method
Inventors
Assignees
Publication Number
US-12263320-B2
Publication Date
2025-04-01
Expiration Date
2034-12-23
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Abstract
An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises at least one of three type of components: access pathway, insertion device, and attachment device. In one embodiment, the device is used to form and/or maintain a percutaneous access pathway into the pleural cavity (i.e. tube thoracostomy). The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Core Innovation
The invention provides improved devices and methods for forming and/or maintaining a percutaneous access pathway. In one embodiment, it is specifically used to establish and maintain a pathway into the pleural cavity for tube thoracostomy, allowing the introduction of devices such as chest tubes, pigtail catheters, endoscopes, or surgical instruments. The assembly generally consists of at least one of three component types: an access pathway (including a catheter and access port), an insertion device, and an attachment device.
A core problem addressed by the invention is the high risk of iatrogenic injury and infection during procedures requiring percutaneous access, such as chest tube placement. Existing methods can cause lacerations to vital structures, have a high risk of infection due to loss of sterility outside operating rooms, and are cumbersome if chest tubes need adjusting or replacing after becoming dislodged or clogged. Maintaining sterility and allowing safe manipulation or replacement of tubes is particularly challenging in emergency or non-operating room environments.
The invention overcomes these deficiencies by providing systems that create a protected, secure access channel into the body. Key embodiments include an access pathway port that closes off the internal body from the outside environment, opening only when a matching attachment device is connected, and prevents disconnection while open, maintaining an internal sterile barrier. The attachment device can contain instruments such as chest tubes inside a sterile, sheath-like compartment, allowing manipulation or replacement without exposing internal body cavities to contaminated environments.
The invention includes features such as expandable/dilatable catheters for establishing the access pathway, mechanisms for locking and securing ports to the body, and quick-connect mechanisms to simplify and expedite device changes or tube placement. The system may also include sheaths or barriers that permit manipulation of internal components from contaminated external environments while preserving sterility within the access pathway. The device and methods are applicable to various body cavities and can be sized or tailored for different patient populations.
Claims Coverage
There are two independent claims that together define the primary inventive features of the device for adjusting and/or replacing a chest tube after initial insertion into a patient.
Barrier-maintaining access pathway port with controlled opening mechanism
The device includes an access pathway port that is capable of maintaining a barrier between the internal portion of the body and the external environment when it is in the closed position. The access pathway port only opens when the attachment device is properly attached, thereby maintaining sterility and preventing exposure to infectious agents or air. Disconnection of the attachment device is automatically prevented when the access pathway port is open, ensuring the barrier is preserved until the system is secure.
Attachment device with internal containment and manipulation sheath
The attachment device is configured to at least partially contain a chest tube and is connectable to the access pathway port. In addition, it features a sheath (which may be sterile, collapsible, and air-impermeable), enabling the chest tube or instrument to be inserted or manipulated from outside the body, while maintaining a protective barrier from the external environment into the body.
The inventive features combine a secure, selectively-opening access port that interfaces with a sheath-containing attachment device, enabling percutaneous access, adjustment, and replacement of chest tubes (or similar devices), while maintaining sterility and preventing unwanted exposure or disconnection.
Stated Advantages
Substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Provides an effective means for forming and/or maintaining a percutaneous access pathway within animals, especially humans.
Allows manipulation, insertion, or replacement of internal devices such as chest tubes without exposing the internal body cavity to the external, potentially non-sterile environment.
Maintains sterility within a closed system even outside of a traditional operating room, addressing challenges in emergency or battlefield settings.
Facilitates easy adjustment or replacement of devices after initial placement without requiring the re-establishment of a sterile field.
Improves safety by minimizing the risk of damaging underlying vital structures during percutaneous access procedures.
Documented Applications
Forming and/or maintaining a percutaneous access pathway for procedures such as tube thoracostomy (placement and management of chest tubes).
Providing access for introducing, adjusting, or replacing chest tubes or similar instruments into the pleural cavity for draining air or fluids including blood, air, serous fluid, chyle, and pus.
Providing percutaneous access to other body cavities, including the abdomen (for laparoscopy or abdominal drains), retroperitoneal space, cranium, trachea, abscesses, or other potential or real body cavities.
Use in various surgical procedures where a reusable port for repeat procedures or manipulation in a non-sterile environment is beneficial.
Placement of access pathways for catheters and tubes such as Penrose drains, pigtail catheters, tracheostomy tubes, endotracheal tubes, venous or arterial catheters, thoracentesis tubes, paracentesis tubes, and for draining abscesses or fluid collections (e.g., empyema, ascites, pleural and other effusions).
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