Percutaneous access pathway system and method

Inventors

Donaldson, Ross I.

Assignees

Critical Innovations LLC

Publication Number

US-10864356-B2

Publication Date

2020-12-15

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 present invention provides improved devices and methods for forming and/or maintaining a percutaneous access pathway. The device broadly includes at least one of three types of components: an access pathway, an insertion device, and an attachment device. In one embodiment, the device is designed to form and/or maintain a percutaneous access pathway into the pleural cavity, enabling procedures such as tube thoracostomy, with the overall assembly structured to reduce the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

Traditional methods for creating percutaneous access pathways pose several risks, such as damaging underlying structures and challenges with maintaining a sterile field, particularly outside an operating room setting. The invention addresses these problems by incorporating features that maintain a physical barrier between the internal and external environment, using ports with doors that remain closed except when an attachment device is properly connected. This system supports the insertion, maintenance, and removal of various medical tubes and devices while minimizing exposure to infection and protecting patient safety.

Embodiments further include mechanisms such as expandable or contractible catheters, doors or valves that control access, sterile sheaths that cover attachment devices, and quick-connect ports to enable secure, sterile, and efficient device exchange. The system is designed to accommodate various entry techniques and can be used in different anatomical locations. It also provides means for securing the pathway to the patient, and may incorporate features such as adhesives, O-rings for airtight sealing, and mechanisms to protect the operator from needle stick injuries.

Claims Coverage

There are two independent claims which define the scope of the inventive features claimed in the patent.

Percutaneous access pathway with access pathway catheter, access pathway port, attachment device, and collapsible sterile sheath

This feature consists of: - An access pathway catheter connecting an internal body portion to the external environment, having a distal opening for insertion. - An access pathway port that maintains a barrier between internal and external environments when closed and includes at least one distal opening connecting to the catheter. - An attachment device connectable to the access pathway port, configured to open the port by actuating one or more doors in the access pathway. - A collapsible attachment device sheath at least partially surrounding the attachment device, enabling insertion of at least part of the device through the port's doors into the body, while maintaining sterility.

Access pathway door configured to open only with attachment device attached and prohibit disconnection while open

This feature includes: - An access pathway door that only opens when the attachment device is attached to the access pathway port. - The access pathway door is constructed so that it prohibits disconnection of the attachment device from the port while the door is open, ensuring a sterile path is maintained during insertion and removal of devices.

The inventive features focus on providing a percutaneous access system with a secure, sterile access port and attachment mechanism, enhancing sterility control and patient safety during access and replacement procedures.

Stated Advantages

Substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

Provides a reusable percutaneous access pathway that can be used in non-sterile environments, such as emergency departments, out-of-hospital settings, or battlefields, while maintaining an internal sterile field.

Minimizes the risk of damaging underlying structures and vital organs during the establishment of a percutaneous access pathway.

Allows for quicker and easier exchange or re-insertion of devices (such as chest tubes) without re-establishing a large sterile field.

Documented Applications

Forming and/or maintaining a percutaneous access pathway into the pleural cavity for tube thoracostomy.

Providing access into the chest, abdomen, retroperitoneal space, cranium, trachea, abscesses, or other potential or real body cavities.

Placement of drains or tubes for laparoscopy procedures allowing repeat access without additional port placement.

Use with standard catheters, Penrose drains, pigtail catheters, chest tubes, tracheostomy tubes, endotracheal tubes, venous or arterial catheters, thoracentesis tubes, paracentesis tubes, or abscess drains.

Providing percutaneous access in a variety of medical procedures involving body cavities, including empyema, ascites, and various effusions.

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