Percutaneous access pathway system
Inventors
Donaldson, Ross I. • Buchanan, Oliver • Fisher, Tim • Armstrong, Jon • Cambridge, John
Assignees
Publication Number
US-12324894-B2
Publication Date
2025-06-10
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 improved devices and methods for forming and/or maintaining a percutaneous access pathway into a patient's body. The assembly generally comprises an access pathway featuring an access pathway port and a catheter, which are designed to minimize iatrogenic infection during both initial access and subsequent reaccess of a body space. The port is designed to substantially reduce the risk of introducing infectious organisms from the skin or the external environment into the patient, addressing the need for reliable, sterile access suitable for use outside the operating room.
A primary deficiency in prior art was the inability to maintain sterility when manipulating or reusing access pathways, especially in non-sterile environments, leading to increased infection risk and procedural complexity. Existing systems required large sterile fields and did not prevent external contamination after initial placement, restricting safe tube adjustment, repositioning, or repeated procedures without extensive re-sterilization or invasive surgery.
The core aspect of the invention is a device with a non-pierceable, lockable access pathway port that, when closed, presents a secure barrier between the internal body and the external environment. The port can be reversibly and securely opened by dedicated attachment devices, which include internally sterile sheaths surrounding internal equipment components, such as chest tubes, surgical instruments, or endoscopes. Only when the appropriate attachment device is connected can the port be opened, ensuring controlled, sterile access. The system further allows for interchangeable, barrier-maintaining connections of various medical devices and supports repeat access, manipulation, drainage, or treatments without needing to establish a new sterile field each time.
Claims Coverage
There is one independent claim, which defines the unique combination and arrangement of the main inventive features.
Access pathway with non-pierceable, lockable access pathway port
The device comprises an access pathway that provides access from the external environment to an internal portion of a patient's body. The access pathway includes an access pathway port configured to maintain a non-pierceable barrier between the body and the external environment when in the closed position. The port is connected through a distal opening to a catheter extending at least partially into the internal portion of the body, allowing for access when the port is open.
Attachment device with internally sterile sheath and internal equipment component
An attachment device, connectable to the access pathway port, is configured to open the port and includes an internally sterile sheath at least partially surrounding an internal equipment component. This sheath allows at least part of the internal equipment component to be inserted into the internal body portion through the access pathway upon connection, maintaining sterility during insertion and manipulation.
Attachment device configured to act as key to port opening
The attachment device is specifically configured such that connection to the access pathway port enables the opening of the port, ensuring that only an appropriately connected attachment device can open the port and thus establish a connection from the external environment to the internal body, maintaining a controlled and sterile access route.
The inventive features together enable a device for percutaneous body access that incorporates a secure, non-pierceable access port; an attachment device that maintains internal sterility; and a mechanism whereby only the proper attachment device can open the port for safe, sterile access.
Stated Advantages
Substantially reduces the possibility of iatrogenic infection while accessing or re-accessing a body space.
Allows repeated access or manipulation of devices in a non-sterile environment without requiring re-establishment of a large sterile field.
Provides an access pathway port that can be reversibly blocked by a lockable, non-pierceable mechanism to prevent air and infection entry.
Permits functional sterilization of the port’s external portion before reattachment of devices, enhancing safety in contaminated environments.
Enables universal access ports to connect serially to multiple different attachment devices with varied clinical applications.
Documented Applications
Forming and/or maintaining a percutaneous access pathway into different body cavities including chest (pleural cavity, heart), abdomen, retroperitoneal, cranium, trachea, abscess, artery, bladder, bone, fluid collection, organ, skull, trachea, vein, vessel, and other body cavities.
Use in thoracostomy procedures (e.g., chest tube placement for pleural drainage in hemothorax, pneumothorax, pleural effusion, chylothorax, pyothorax), especially where repeated access or repositioning is needed.
Use in abdominal procedures (e.g., laparoscopic placement of abdominal drains) to facilitate repeat laparoscopy or drainage procedures outside an operating room.
Use in neurosurgical access to the cranium for introducing devices such as ventriculostomy tubes, intracranial pressure monitors, or external ventricular drains.
Application for insertion of devices such as Penrose drains, pigtail catheters, tracheostomy tubes, endotracheal tubes, venous or arterial catheters, thoracentesis or paracentesis tubes, abscess drainage, and other catheters.
Facilitating endoscopic and minimally invasive procedures (e.g., thoracoscopy, VATS, pleuroscopy, tissue biopsy, pleurodesis) in environments lacking operating room sterility.
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