Image guided catheters and methods of use
Inventors
Dykes, Christopher Allen • Zipparo, Michael J. • Abraham, Theodore P.
Assignees
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Abstract
An interventional medical device is provided that incorporates a forward-directed ultrasound or optical coherence tomography imaging system that is replaceable depending on how close the device is to the target site for a given medical procedure, the device and system integrated into a single minimally invasive device comprising a first probe housing, needle guide assembly and sheath, a sleeve lock for closing a normally open needle channel of a needle guide of the first distal assembly and a second probe and cable housing assembly locked to the first distal probe housing, needle guide assembly and sheath by a locking tab. The probe and cable housing assembly may comprise a linear phased ultrasound array and an accelerometer for orienting an image produced by the device with the gravitational field of the earth. The medical device can be in the form of an image guided catheter or probe, used in a body orifice, externally on skin tissue or subcutaneously. The device comprises a replaceable and reusable ultrasound imaging assembly (and or OCT assembly) and replaceable interventional devices such as a removable introducer needle, hollow biopsy needle, syringe or other medical instrument. The imaging system may comprise one or more small ultrasound or OCT imaging systems that can be replaceably integrated into the device by replacing the reusable second probe and cable housing assembly.
Core Innovation
The invention relates to a sheath body that supports a forward looking imaging device and an open-ended lumen configured to receive a medical tool. The sheath body includes a closed-end lumen configured to receive the forward looking imaging device and an open-ended lumen oriented relative to the closed-end lumen. The open-ended lumen comprises a first movable guide and a second movable guide and is configured to transition between an open configuration and a closed configuration.
In the open configuration, surfaces of the movable guides do not contact, and in the closed configuration the surfaces contact each other. When the medical tool is loaded into the open-ended lumen, a portion of the medical tool that protrudes from the open-ended lumen is within a forward imaging field of view of the forward looking imaging device. The medical tool is insertable and removable from the sheath body when the open-ended lumen is in the open configuration.
The invention also provides an image guided medical procedure using the sheath body and the sheath-delivered tool. The method includes loading the forward looking imaging device into the closed-end lumen and loading a medical tool into the open-ended lumen, and at least a portion of a medical procedure is performed on a subject using the medical tool loaded in the open-ended lumen while viewing the medical tool through the forward imaging field of view of the forward looking imaging device.
Claims Coverage
The patent includes two independent claims and recites four central inventive features.
Forward imaging sheath with movable guide open/closed configurations
A sheath body comprising a closed-end lumen configured to receive a forward looking imaging device and an open-ended lumen comprising a first movable guide and a second movable guide, the open-ended lumen configured to transition between an open configuration and a closed configuration and configured to receive a medical tool.
Oriented protruding medical tool within forward imaging field of view
The open-ended lumen is oriented with respect to the closed-end lumen such that when the medical tool is loaded into the open-ended lumen, a portion of the medical tool that protrudes from the open-ended lumen is within a forward imaging field of view of the forward looking imaging device.
Insertable and removable medical tool when open-ended lumen is open
The medical tool is insertable and removable from the sheath body when the open-ended lumen is in the open configuration.
Image guided procedure using forward imaging and tool protruding visibility
A method of performing an image guided medical procedure comprising providing a sheath body with a closed-end lumen configured to receive a forward looking imaging device and an open-ended lumen with a first movable guide and a second movable guide that transition between open and closed configurations, and performing at least a portion of a medical procedure on a subject using the medical tool loaded in the open-ended lumen while viewing the medical tool through the forward imaging field of view of the forward looking imaging device.
Across the independent claims, the inventive structure and use are defined by a sheath body with a closed-end lumen for a forward looking imaging device, an open-ended lumen with first and second movable guides that transition between open and closed configurations, orientation ensuring a protruding portion of the medical tool lies within the forward imaging field of view, and insertability/removability of the medical tool when the open-ended lumen is open.
Stated Advantages
Allows viewing of the medical tool through a forward imaging field of view of a forward looking imaging device while performing at least a portion of a medical procedure.
Enables insertable and removable handling of the medical tool from the sheath body when the open-ended lumen is in the open configuration.
Positions a protruding portion of the medical tool within the forward imaging field of view when the medical tool is loaded into the open-ended lumen.
Documented Applications
Performing an image guided medical procedure on a subject using a forward looking imaging device and a medical tool loaded in an open-ended lumen while viewing the medical tool through the forward imaging field of view of the forward looking imaging device.
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