Percutaneous access pathway system

Inventors

Donaldson, Ross I.Buchanan, OliverFisher, TimArmstrong, JonCambridge, John

Assignees

Critical Innovations LLC

Publication Number

US-10814119-B2

Publication Date

2020-10-27

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 present invention provides improved devices and methods for forming and/or maintaining a percutaneous access pathway into a patient's body. The assembly comprises an access pathway and attachment device that substantially reduces the possibility of iatrogenic infection when accessing or re-accessing a body space. The access pathway often includes a catheter irreversibly attached to a port that allows for secure, reversible connection to one or more attachment devices, creating a controlled entrance from the exterior to interior body spaces.

In many embodiments, the access pathway port can be reversibly blocked by a lockable, non-pierceable port that prevents air or infection from entering the body cavity. Only the connection of a compatible attachment device allows the port to unlock and open, which maintains isolation from the external environment when not in use. The attachment device typically includes a sterile sheath around the internal equipment component, allowing insertion, manipulation, and removal without exposing internal parts to contamination.

The invention addresses deficiencies in previous access systems, which faced significant infection risk outside sterile environments, could not easily accommodate movement or replacement of internal components, and required re-creation of large sterile fields for repeated procedures. The provided assembly is designed for safe, repeated access with minimal need for external sterility, and includes interchangeable attachment devices for various clinical needs.

Claims Coverage

There are three independent claims covering the inventive features of the device and system for forming and/or maintaining a percutaneous access pathway.

Access pathway with lockable, non-pierceable port

The device includes an access pathway with a port configured to maintain a non-pierceable barrier between the body and external environment when closed. The port features a lock to securely maintain closure and has a distal opening for a catheter to extend into the body upon opening.

Attachment device with sterile sheath and port actuation

An attachment device is connectable to the access pathway port and is configured to open the port. The attachment device includes an internally sterile sheath at least partially surrounding an internal equipment component, enabling insertion into the body only when the attachment is connected.

Quick-connect access system supporting various attachments

A system comprises an access pathway (catheter and port) and one or more attachment devices that can unlock and open the port. The system provides an airtight, non-pierceable, locked barrier when closed, and allows connection and serial interchange of multiple attachment devices for different clinical uses.

The inventive features enable secure, repeatable, and minimally infectious percutaneous access using a lockable, non-pierceable port, an internally sterile sheath in attachment devices, and an access system supporting various interchangeable attachments.

Stated Advantages

The assembly substantially reduces the possibility of iatrogenic infection during access or re-access of a body space.

It minimizes or eliminates the need for maintaining a large sterile field outside of the operating room.

The device allows later manipulation, exchange, or movement of internal components without requiring a new sterile field.

The system supports repeated access for procedures without the need to replace the port or recreate sterility.

The externally exposed port can be cleaned or sterilized before reconnecting an attachment device.

Interchangeable attachments allow multiple diagnostic and therapeutic tools to be used without repeating invasive access.

The invention can be used outside the operating room (e.g. battlefield, emergency department, intensive care) while maintaining infection control.

Documented Applications

Forming and/or maintaining a percutaneous access pathway into body cavities such as the chest (pleural cavity, heart), abdomen, retroperitoneal, cranium, trachea, abscess, artery, bladder, bone, collections of fluid, organ, skull, vein, or vessel.

Placement of chest tubes for tube thoracostomy and facilitating repeated drainage or procedures.

Insertion of surgical equipment for minimally invasive procedures such as VATS, thoracoscopy, laparoscopic surgery, single-port or multi-port access surgery, and neurosurgery.

Connection to diagnostic and treatment tools such as pigtail catheters, tracheostomy tubes, endotracheal tubes, venous or arterial catheters, thoracentesis tubes, paracentesis tubes, drains for abscesses, and other catheters.

Facilitation of autotransfusion and/or cell salvage using blood captured via attachment devices.

Use for procedures involving loop irrigation, endoscopic visualization, and internal suction or irrigation systems.

Introduction of ventriculostomy tubes, intracranial pressure monitors, intracranial oxygen monitors, external ventricular drains, devices to drain intracranial hemorrhage, and other ventricular shunts.

Enabling various thoracic and abdominal surgical interventions (e.g., tissue biopsy, pleurodesis, management of empyema, lung biopsy, repair of bronchopleural fistula, decortication, pneumonectomy, and resection of masses or tumors).

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