Image guided catheters and methods of use

Inventors

Abraham, Theodore P.

Assignees

Perceptive Navigation LLC

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Publication Number

US-9855021-B2

Patent

Publication Date

2018-01-02

Expiration Date


Abstract

An interventional medical device is provided that incorporates a forward-directed ultrasound imaging system integrated into a single minimally invasive device. The medical device can be in the form of an image guided catheter having a replaceable and reusable ultrasound imaging assemble and replaceable interventional devices such as a removable introducer needle and syringe, the device having a tapered distal tip, particularly those suitable for minimally invasive direct introduction into the human or other mammalian body. The imaging system comprises one or more small ultrasound transducers that can be replaceably integrated into the device via a longitudinal slot in an expendable elongate body and may be inserted into and removed from the device to customize the device for a particular use. An ultrasound system can be provided in the device either alone or in combination with fiber optic imaging to provide a range of forward imaging and therapeutic capabilities of the device for direct access to a target site from the skin via the removable introducer needle.

Core Innovation

The invention provides an image guided catheter device configured to be used in minimally invasive medical procedures. The device includes an elongate cylindrical housing having an expendable or disposable housing component with a tapered tip at the distal end that is directly inserted via skin tissue and guidable to a target site within a human body during use. The expendable housing component has at least one closed longitudinal imaging lumen at the distal end and at least one longitudinal tool lumen extending parallel to the imaging lumen.

At the distal end of the expendable housing component, the at least one closed longitudinal imaging lumen terminates at a peripheral location behind a tapered distal tip and includes an open longitudinal slot opening at a proximal end adjacent and connected to the closed longitudinal imaging lumen. The open longitudinal slot opening is configured for receiving different removable, replaceable imaging transducer, fiber optic or optical coherence assemblies that fit in the open slot opening and slide forward to the distal end, with a first imaging element disposed at the distal end of the removable, replaceable imaging assembly to provide forward-directed imaging in a direction of the distal end to include the distal tip.

The invention further provides a removable, replaceable introducer tool disposed within the longitudinal tool lumen at an end-on aperture within the tapered distal tip, and in a forward-directed imaging zone of the ultrasound transducer such that the introducer tool and the image guided catheter device are introduced into the human body simultaneously during a medical procedure. In embodiments, the removable, replaceable introducer tool is one of solid and hollow and is configured, under ultrasound forward-directed imaging guidance, to puncture a human body wall proximate to the target site and to directly access the target site.

Claims Coverage

The partial content includes three independent claims that share a removable, replaceable forward-directed imaging transducer assembly slidably received in a closed longitudinal lumen behind a tapered distal tip, and a removable, replaceable introducer tool delivered via a parallel tool lumen and end-on aperture. Across the independent claims, the inventive features are directed to the expendable or disposable housing with tapered distal access, the longitudinal slot opening for receiving replaceable imaging assemblies, and the use of a forward-directed ultrasound imaging element for guidance with a puncturing introducer tool.

Expendable tapered distal housing with parallel imaging and tool lumens

An image guided catheter device including an elongate cylindrical housing with an expendable or disposable housing component having a distal tapered tip configured to be directly inserted via skin tissue and guidable to a target site, the expendable housing component having at least one closed longitudinal imaging lumen at the distal end and at least one longitudinal tool lumen, and an open longitudinal slot opening for receiving different removable, replaceable imaging transducer, fiber optic or optical coherence assemblies adapted to fit in the open slot opening and slide forward to the distal end of the closed longitudinal imaging lumen.

Forward-directed imaging from a replaceable distal imaging assembly connected to a display

A first imaging element disposed at a distal end of the removable, replaceable imaging transducer, optical fiber or optical coherence imaging assembly, where the closed longitudinal imaging lumen terminates at a peripheral location behind a tapered distal tip and is adapted to receive the removable, replaceable imaging assembly at its proximal slot opening and slide forward into the closed longitudinal imaging lumen to its distal end, and where the imaging assembly is electrically connected to an output display device to provide forward-directed imaging to include the distal tip.

Removable replaceable introducer tool disposed at an end-on aperture for ultrasound-guided puncture

A removable, replaceable introducer tool disposed within the longitudinal tool lumen at an end-on aperture within the tapered distal tip, the longitudinal tool lumen being parallel to the at least one closed longitudinal imaging lumen, with the introducer tool disposed within a forward-directed imaging zone of the ultrasound transducer for ultrasound forward-directed imaging guidance to puncture a human body wall proximate to the target site and directly access the target site.

Replaceable ultrasound transducer assembly slidably received in a lengthwise slot to position near a distal window

An image guided catheter device with an elongate housing having a tapered tip directly inserted into a target site from skin tissue, the elongate housing having a lengthwise slot at the proximal end for receiving a removable, replaceable imaging transducer assembly including an ultrasound transducer and at least one closed longitudinal lumen for receiving the ultrasound imaging transducer assembly, where the closed longitudinal lumen is connected to a longitudinal open slot at its proximal end to allow the ultrasound imaging transducer assembly to slide forward into the closed longitudinal lumen until reaching its distal end and position a first imaging element proximate a window at the distal end of the elongate housing.

Introducer tool longitudinal lumen for removable replaceable introducer tool and syringe reception

A removable, replaceable introducer tool disposed within an end-on aperture within the distal tip of the tapered tip and within an introducer tool longitudinal lumen extending through the elongate housing from the proximal end to the distal tip, where the introducer tool longitudinal lumen is parallel to the at least one closed longitudinal lumen for receiving the removable, replaceable imaging transducer assembly, and where the introducer tool longitudinal lumen extends through the elongate housing from the proximal end to the distal end for receiving a syringe including the removable, replaceable introducer tool.

Disposable tapered housing with s-shaped transducer assembly slot and ultrasound-guided puncturing introducer

An image guided catheter device including a disposable housing with a tapered tip at the distal end and at least one closed longitudinal imaging lumen extending along the longitudinal axis of the distal end, where the proximal end has a lengthwise slot configured to receive a transducer assembly having an S-shape comprising a straight portion, a bend and a continued straight portion, the lengthwise slot connected to the at least one closed longitudinal imaging lumen and adapted to receive the transducer assembly to slide forward into the closed longitudinal imaging lumen, and where the transducer assembly is replaceable and removable during a medical procedure and includes a distal end having an ultrasound transducer for insertion and slideable movement forward into the closed longitudinal imaging lumen.

Solid or hollow introducer tool disposed in the forward-directed imaging zone for simultaneous access

A removable, replaceable introducer tool and syringe disposed within a forward-directed imaging zone of the ultrasound transducer via an end-on aperture of the tapered tip, where the introducer tool and the image guided catheter device are introduced into the human body simultaneously during a medical procedure, where the removable, replaceable introducer tool is one of solid and hollow and is configured, under ultrasound forward-directed imaging guidance, to puncture a human body wall proximate to the target site and to directly access the target site, and where the introducer tool extends from the end-on aperture and is within the forward-directed imaging zone of the ultrasound transducer during use.

Across the independent claims in the provided partial content, the core claim coverage centers on a tapered distal housing with an open longitudinal slot that enables removable, replaceable imaging transducer, fiber optic or optical coherence assemblies to slide into closed longitudinal imaging lumens to provide forward-directed ultrasound imaging, together with a parallel introducer tool disposed at an end-on aperture for guidance during minimally invasive procedures, including puncturing a body wall proximate to a target site for direct access.

Stated Advantages

Documented Applications

Minimally invasive medical procedures using the image guided catheter device.

Medical procedure in which the removable, replaceable introducer tool is configured to puncture a human body wall proximate to the target site and directly access the target site under ultrasound forward-directed imaging guidance.

Intracardiac treatment through pericardial access, where the introducer tool is adapted to puncture the pericardium during use.

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