Percutaneous access pathway system
Inventors
Donaldson, Ross I. • Buchanan, Oliver • Hamdan, Muhammed • Fisher, Tim • Cambridge, John • Armstrong, Jonathan
Assignees
Publication Number
US-11832833-B2
Publication Date
2023-12-05
Expiration Date
2040-10-05
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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. The provided assembly substantially reduces the possibility of injury 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, particularly into body spaces such as the cranium. The assembly substantially reduces the possibility of injury while accessing or re-accessing a body space, and emphasizes methods that minimize the introduction of infectious organisms from the external environment into the body while facilitating diagnostic or therapeutic procedures requiring internal access.
A central problem addressed is the lack of optimized devices for percutaneous intracranial access, especially usable outside sterile operating rooms. Traditional neurosurgical approaches require a sterile environment, specialized drills, and are complex for non-neurosurgeons, making procedures like burr hole drainage or ventricular monitoring difficult or impractical in settings such as battlefields, emergency departments, or rural areas. This results in critical delays for patients needing rapid intervention for conditions like life-threatening intracranial hemorrhage.
The invention overcomes these deficiencies by providing an access pathway device with an auto-stopping mechanism to prevent tissue injury, a sealable port for secure and repeat access, and adaptability for connecting to a variety of attachment devices. Its design allows for placement with or without a sterile drill, includes features for easily sterilizing the external portion for re-access, and provides a system of universal or interchangeable attachments for various clinical needs. The access pathway can be fixed to the body, prevents infection, and offers controlled access with non-pierceable, lockable ports that open only upon secure connection with an attachment.
Claims Coverage
The patent contains a single independent claim describing several inventive features that together define the innovative scope of the device.
Means for providing rotational force to distal cutting or drilling elements
The device includes a mechanism that delivers rotational force to one or more distal rotary cutting or drilling elements, enabling penetration of bone. - The rotational force can be from an external drill or incorporated internal drilling mechanism. - This enables creation of a percutaneous access pathway through bone.
Clutch mechanism connected to a stabilizer for automatic disengagement upon bone penetration
A clutch mechanism is functionally connected to a stabilizer and is configured to: - Cause the cutting or drilling elements to penetrate bone. - Automatically disengage once bone penetration is achieved. - Minimize risks of plunging and injury to underlying structures. - Includes a lock configured to selectively engage and disengage with the stabilizer, and a key to control this engagement.
Stabilizer configured to provide counterforce with minimal injury to soft tissue
The stabilizer is: - Configured to provide counterforce against device advancement. - Disposed on an area away from the immediate site of bone penetration. - Designed to allow pushback from intact skin or soft tissues while causing minimal or no injury to them.
Sealable means for repeat percutaneous access through the device
The device features a sealable component enabling repeat percutaneous access from the external environment into the patient's body. - This allows for ongoing or repeat procedures through the same access pathway.
The inventive features focus on an access device for bone penetration that safely halts upon entry, minimizes risk to underlying tissues, employs a stabilizer and clutch system, and provides sealable repeat access for medical procedures.
Stated Advantages
Substantially reduces the possibility of injury while accessing and/or re-accessing a body space.
Substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.
Allows rapid and minimally invasive access outside the sterile operating room.
Provides secure, repeat percutaneous access without requiring a large sterile field or complicated neurosurgical tools.
Permits sterilization of the external portion before re-access, maintaining a functionally sterile pathway in non-sterile environments.
Single access port can connect to multiple attachment devices tailored to different clinical needs.
The auto-stopping and sealable mechanisms minimize risk of tissue damage and infection.
Documented Applications
Forming and/or maintaining a percutaneous access pathway into the cranium for neurosurgical procedures, including epidural drainage or intracranial monitoring.
Providing rapid intracranial access for emergent treatment of conditions such as epidural hematoma in trauma patients.
Placement of an external ventricular drain or ventriculostomy in settings outside the operating room.
Insertion of various equipment such as intracranial pressure monitors, oxygen monitors, hematoma drains, endoscopes, irrigation and suction devices, and related surgical instruments.
Access to other body cavities including chest (pleural cavity, heart), abdomen, retroperitoneal space, trachea, abscess, artery, bladder, bone, fluid collections (empyema, ascites, effusion), organ, vein, vessel, and other body cavities.
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