Image guided catheters and methods of use
Inventors
Dykes, Christopher Allen • Zipparo, Michael J. • Abraham, Theodore P.
Assignees
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Publication Number
US-11660067-B2
Publication Date
2023-05-30
Expiration Date
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 provides an image guided sheath body having a closed-end lumen configured to receive a forward looking imaging device, and an open-ended lumen configured to receive a medical tool. 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.
The sheath body further comprises a tool-release mechanism and comprises a first movable guide and a second movable guide. The open-ended lumen transitions between an open configuration, in which a surface of the first movable guide and a surface of the second movable guide do not contact each other, and a closed configuration, in which the surface of the first movable guide and the surface of the second movable guide contact each other.
In the closed configuration, the open-ended lumen permits the forward imaging field of view to maintain the protruding portion of the medical tool, while the sheath body enables insertion and removal of the medical tool in the open configuration. The tool-release mechanism enables real-time replacement of a transducer assembly and supports replacement of interventional tools, and orientation aiding is provided via an accelerometer and/or gyroscope to align images with gravity.
Claims Coverage
The partial content provides two independent claims: one directed to a sheath body and one directed to a method of performing an image guided medical procedure. Across the independent claims, the inventive features focus on maintaining the protruding portion of a loaded tool within the forward imaging field of view while transitioning an open-ended lumen between open and closed configurations using movable guides and a tool-release mechanism.
Sheath body with forward imaging field of view for a protruding tool portion
A sheath body comprising a closed-end lumen configured to receive a forward looking imaging device; and an open-ended lumen configured to receive a medical tool, 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.
Tool-release mechanism with first and second movable guides for open and closed configurations
The sheath body further comprises a tool-release mechanism, comprises a first movable guide and a second movable guide, and is configured to transition between an open configuration in which a surface of the first movable guide and a surface of the second movable guide do not contact each other and a closed configuration in which the surface of the first movable guide and the surface of the second movable guide contact each other, the open configuration permitting insertion and removal of the medical tool from the open-ended lumen.
Method using the forward imaging field of view while performing the procedure
A method of performing an image guided medical procedure on a subject, comprising providing a sheath body comprising a closed-end lumen configured to receive a forward looking imaging device and an open-ended lumen configured to receive a medical tool 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; loading a forward looking imaging device into the closed-end lumen; loading a medical tool into the open-ended lumen; 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.
The independent claims jointly cover a sheath body structure and a corresponding procedure in which the forward imaging field of view includes the protruding portion of a loaded medical tool, combined with a tool-release mechanism and an open/closed transition implemented using first and second movable guides.
Stated Advantages
Allows a protruding portion of the medical tool to be within a forward imaging field of view of the forward looking imaging device while the medical procedure is performed.
Enables insertion and removal of the medical tool in an open configuration via the transition of the first and second movable guides between open and closed configurations.
Documented Applications
Image guided medical procedures on a subject using a forward looking imaging device while viewing the medical tool through the forward imaging field of view.
Cardiocentesis/pericardial procedures.
Biopsy applications.
Valve-related procedures.
Other interventional procedures.
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