Image guided catheters and methods of use

Inventors

Abraham, Theodore P.

Assignees

Perceptive Navigation LLC

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Publication Number

US-9149257-B2

Patent

Publication Date

2015-10-06

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 catheters and interventional devices 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 permanently integrated into the device or integrated into an interchangeable ultrasound transducer that 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 an introducer needle.

Core Innovation

The patent describes an image guided catheter device configured to be used in minimally invasive medical procedures. An elongate body includes a tapered tip at the distal end and at least one longitudinal lumen extending along a longitudinal axis to the tapered tip, which includes an end-on aperture. A removable introducer needle is disposed at the tapered tip so that it extends from the end-on aperture into the human body while remaining within a forward-directed imaging zone.

Forward-directed ultrasound imaging is provided by a first imaging element disposed at the distal end of the elongate body, including a first ultrasound transducer located at an outer periphery of the tapered tip behind the distal tip. The first ultrasound transducer provides a forwardly guided imaging zone from the distal end to include the tapered tip of the elongate body, and the ultrasound forward-directed imaging is used to guide the image guided catheter device from a point of entry through the tissue of the human body to the target site.

Under the ultrasound forward-directed imaging guidance, the removable introducer needle punctures human body tissue proximate the target site and directly accesses and punctures the target site during use of the image guided catheter device. The ultrasound transducer provides imaging of forward navigation of the elongate body from entry into the human body to a location proximate the target site, and the removable introducer needle is arranged so that, during use, it is located within the forward-directed imaging zone of the ultrasound transducer when extending from the end-on aperture.

Claims Coverage

The provided partial content includes three independent claims, each centering on forward-directed ultrasound imaging from a distal tapered tip and substantially simultaneous introduction of a removable introducer needle to puncture and access a target site under ultrasound guidance. Across the independent claims, the inventive features repeatedly include an elongate body with a tapered tip, an ultrasound transducer providing a forward-directed imaging zone, and a removable introducer needle disposed so it lies within the imaging zone during puncture and access.

Forward-directed ultrasound imaging with tapered distal tip

An elongate body configured for minimally invasive entry with a tapered tip at the distal end, where a first imaging element disposed at the distal end includes a first ultrasound transducer located at an outer periphery behind the distal tip, and wherein the first ultrasound transducer provides a forward-directed imaging zone from the distal end to include the tapered tip.

Substantially simultaneous needle insertion guided by ultrasound imaging zone

A removable introducer needle disposed at an end-on aperture within the distal tip of the tapered tip and located within the forward-directed imaging zone of the first ultrasound transducer during extension, the removable introducer needle configured to be introduced substantially simultaneously with the image guided catheter device and to be guided under ultrasound forward-directed imaging guidance to puncture and access a location proximate to the target site.

Needle puncture and direct access proximate to target site via forward-directed imaging

The removable introducer needle configured, under ultrasound forward-directed imaging guidance, to puncture human body tissue proximate the target site and directly access the target site during use via the forward-directed imaging zone of the first ultrasound transducer.

Forwardly guiding the device from entry point to target site using ultrasound transducer

The first imaging element configured to forwardly guide the image guided catheter device from a point of entry through tissue of the human body to the target site within the human body during use, by providing forward-directed imaging in a forward direction from the distal end to include the tapered tip of the elongate body.

Needle disposed within forward-directed imaging zone at tapered tip while inserted with the device

An elongate body with a tapered tip configured to be directly inserted into a target site, where a removable introducer needle is disposed within a forward-directed imaging zone of an ultrasound transducer via an end-on aperture of the tapered tip, and the removable introducer needle and the device are configured to be introduced into the human body substantially simultaneously during use.

Forward navigation imaging from entry to location proximate the target site

A first imaging element disposed at the distal end including the ultrasound transducer configured to provide forward-directed imaging in a forward direction from the distal end to include the tapered tip, where the tapered tip has the end-on aperture as a most distal portion forward of the ultrasound transducer, and the first imaging element provides imaging of forward navigation of the elongate body from entry to a location proximate the target site.

The independent claims cover an image guided catheter device for minimally invasive medical procedures that uses a distal ultrasound transducer in a tapered tip arrangement to provide forward-directed imaging and to guide both the device and a removable introducer needle. Each independent claim ties the needle’s puncture and access function to its placement within the ultrasound forward-directed imaging zone during substantially simultaneous introduction with the catheter, and each specifies forward-directed imaging configured to include the tapered tip and target site region.

Stated Advantages

Allows the removable introducer needle to be introduced substantially simultaneously with the image guided catheter device during minimally invasive use.

Provides ultrasound forward-directed imaging guidance so the removable introducer needle punctures and directly accesses the target site proximate to the target site location.

Provides forward-directed imaging configured to forwardly guide the image guided catheter device from a point of entry through tissue to the target site.

Documented Applications

Minimally invasive medical procedures in a human body, including puncturing and accessing a target site during use of the image guided catheter device.

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