Percutaneous access pathway system
Inventors
Donaldson, Ross I. • Buchanan, Oliver • Fisher, Tim • Armstrong, Jon • Cambridge, John
Assignees
Publication Number
US-11406809-B2
Publication Date
2022-08-09
Expiration Date
2038-08-27
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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 an access pathway and attachment device. The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Core Innovation
The invention provides an improved device and method for forming and/or maintaining a percutaneous access pathway into a patient’s body. The assembly consists of an access pathway, comprising a catheter and a port, and an attachment device. The access pathway port maintains a non-pierceable, lockable barrier between the internal body and external environment when closed, and only allows opening when a compatible attachment device is securely connected. This design substantially reduces the risk of iatrogenic infection by preventing uncontrolled exposure between the body and the external environment during access or re-access.
The problem addressed by this invention concerns the significant infection risk in existing percutaneous access procedures, particularly tube thoracostomy performed outside a sterile operating room. Traditional systems require maintaining a large sterile field and are susceptible to accidental contamination, leading to potential infections, difficulty in safe repositioning or replacement of tubes, and procedural delays. The inability to repeatedly access the pathway without reestablishing a sterile field further complicates patient care, sometimes necessitating more invasive interventions.
By combining an access port with a lockable, non-pierceable barrier and an attachment device that can reversibly and securely engage the port, the invention allows serial access without compromising sterility. The attachment device features a sheath that surrounds the internal equipment (e.g., chest tube, endoscope, surgical instrument), ensuring sterile delivery into the body, and includes a reversible locking mechanism for controlled manipulation. The system supports interchanging different attachments for various purposes (such as drainage, suction, or endoscopy), enabling safe, repeated, and efficient percutaneous access even in non-operating room environments.
Claims Coverage
The claims define two independent inventive features: a device for forming and/or maintaining a percutaneous access pathway (Claim 1) and a system for such a pathway (Claim 19).
Device with access pathway port forming a non-pierceable barrier and a sterile attachment device
The device includes an access pathway port that, when closed, maintains a non-pierceable barrier between the internal portion of a patient's body and the external environment. This port connects through a distal opening to an access pathway catheter that extends into the body, allowing access only when the port is open. An attachment device, connectable to the port, is configured to open the access pathway port and comprises an internally sterile sheath that at least partially surrounds an internal equipment component (e.g., chest tube, endoscope, surgical tool). The sheath enables insertion of the internal equipment into the body through the access pathway when the device is connected, and the attachment device includes a reversible locking mechanism that engages with the internal equipment component.
System with access pathway port, catheter, and multiple sterile attachment devices
The system provides an access pathway with an access pathway catheter having a distal opening to be extended into the body, and an access pathway port that, in its closed position, provides an airtight, non-pierceable barrier between the internal portion of the body and the external environment. The system includes one or more attachment devices, each connectable to the access pathway port and configured to allow opening of the port. Each attachment device contains an internally sterile sheath at least partially surrounding an internal equipment component and a reversible locking mechanism that engages with that equipment component.
In summary, the claims cover a device and system for percutaneous access that utilize a port providing a non-pierceable barrier, a sterile sheath for internal equipment delivery, and mechanisms allowing safe, reversible, and controlled access to body cavities.
Stated Advantages
Substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Allows repeatable and reversible connection of different attachment devices without reestablishing a sterile field.
Facilitates percutaneous access procedures outside of a sterile operating room, such as in emergency departments, intensive care units, or out-of-hospital environments.
Provides a means for easy cleaning or sterilization of the external portion of the port prior to reconnecting an attachment.
Allows secure, controlled insertion and positioning of various internal equipment components, reducing risk of complications.
Enables exchange or manipulation of tubes or instruments in situ without direct external exposure to the body cavity.
Supports universal port compatibility with various attachment devices, simplifying clinical workflow.
Documented Applications
Forming and/or maintaining a percutaneous access pathway into different body cavities, including but not limited to the chest (pleural cavity, heart), abdomen, retroperitoneal space, cranium, trachea, abscess, artery, bladder, bone, fluid collections, organ, skull, vein, vessel, or other body cavity.
Use in chest procedures such as tube thoracostomy for drainage of air (pneumothorax), blood (hemothorax), pleural effusion, hydrothorax, chylothorax, and pyothorax.
Facilitating video-assisted thoracoscopic surgery (VATS), laparoscopic surgery, and neurosurgical procedures through repeatable and sterile port access.
Providing pathways for insertion of chest tubes, pigtail catheters, tracheostomy tubes, endotracheal tubes, venous or arterial catheters, thoracentesis tubes, paracentesis tubes, and abscess drainage tubes.
Introducing neurosurgical equipment such as ventriculostomy tubes, intracranial pressure monitors, intracranial oxygen monitors, external ventricular drains, devices to drain intracranial hemorrhage, or other ventricular shunts.
Enabling repeated or serial use of internal equipment such as surgical instruments, endoscopes, suction or irrigation equipment, and other drainage or biopsy tools.
Use in adult, pediatric, and infant patients through varying device lengths and sizes.
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