Percutaneous access pathway system and method
Inventors
Assignees
Publication Number
US-11865281-B2
Publication Date
2024-01-09
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 a patient. The device generally comprises an access pathway (including a catheter and access pathway port), an insertion device, and an attachment device. The system is particularly suited for procedures such as tube thoracostomy, where it allows the formation and maintenance of a channel into a body cavity, such as the pleural space, and facilitates the introduction of medical devices like chest tubes or surgical instruments while maintaining a closed, sterile system.
A core problem addressed by the invention is the risk of iatrogenic injury and infection associated with current percutaneous access procedures, such as damaging underlying structures during chest tube placement, maintaining sterility in non-operating room environments, and difficulties in repositioning or replacing chest tubes without re-establishing a sterile field. The invention aims to substantially reduce the possibility of iatrogenic infection during initial and repeat access to the body space by providing a reusable, sealable port that maintains sterility and forms a secure, controllable access point.
Key features include mechanisms by which the access pathway port only opens when an attachment device is connected, preventing ambient air or infection from entering the body when the port is not in use. Various embodiments allow the access pathway to be anchored or secured to the body, may include mechanisms for expansion and contraction for easy placement and removal, and offer the ability to connect external devices or suction systems. Additionally, many embodiments provide means for external manipulation via a sterile sheath, enabling procedures to be performed even in environments where maintaining a sterile field is challenging.
Claims Coverage
The patent includes two independent claims, each describing a device for forming and/or maintaining a percutaneous access pathway into a body of a patient, with multiple inventive features.
Percutaneous access pathway with access pathway port and controlled opening mechanism
- The device comprises an access pathway catheter connected to an access pathway port, which maintains a barrier between the internal body portion and the external environment when closed. - The access pathway port is configured with at least one distal opening connecting to the catheter. - An attachment device is connectable to the access pathway port and is configured to selectively allow the port to open by opening one or more doors in the access pathway. - The mechanism formed by the access pathway port and the attachment device only allows the port to open when the attachment device is attached, and it automatically prevents disconnection of the attachment device while the port is open.
Access pathway door mechanism for controlled access and sterility
- The device includes an access pathway door in the access pathway port that is reversibly opened and closed. - The pathway is configured to enable opening of the access pathway door only when the attachment device is connected. - The attachment device is connectable to allow insertion of at least part of the attachment device into the internal portion of the body through the access pathway door when connected. - The mechanism automatically prohibits disconnection of the attachment device from the access pathway port when the access pathway port is open.
The inventive features focus on the integration of a catheter, a controlled-access port, and an attachment device that together maintain sterility and security for percutaneous access by permitting entry only when appropriately connected. The mechanism prevents contamination and unintentional disconnection, thus addressing vital concerns in percutaneous access procedures.
Stated Advantages
Substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Minimizes the chances of iatrogenic injury to the patient by providing controlled and secure access.
Allows maintenance of sterility during placement and repeat access, even in non-operating room environments.
Enables rapid and secure attachment and removal of medical devices (such as chest tubes) without re-establishing a sterile field.
Provides reversible and secure closing of the port, preventing entry of air or infectious material when not in use.
Offers adaptability for use in differently sized patients and various body cavities.
Documented Applications
Forming and/or maintaining a percutaneous access pathway into the pleural cavity, such as for tube thoracostomy.
Introduction and maintenance of chest tubes of different sizes, pigtail catheters, endoscopes, video-assisted thoracoscopic surgery devices, or other surgical instruments.
Establishing access pathways in the chest, abdomen, retroperitoneal space, cranium, trachea, abscess, or other body cavities for drainage of air, fluids, or other substances.
Repeat procedures requiring reusable or replaceable ports in body cavities, such as abdominal drains for repeated laparoscopy.
Procedures performed outside a standard sterile operating room, such as in emergency departments or battlefield settings.
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