Image guided catheters and methods of use
Inventors
Assignees
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Publication Number
US-8403859-B2
Publication Date
2013-03-26
Expiration Date
Abstract
An interventional medical device is provided that incorporates a forward-directed ultrasound imaging system integrated into a single device. The medical device can be in the form of sheaths, catheters, and interventional devices, particularly those suitable for minimally invasive procedures in 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 can 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 imaging and therapeutic capabilities of the device.
Core Innovation
The invention relates to an interventional minimally invasive medical device that integrates a forward-directed ultrasound imaging system into an elongate body without an exterior delivery catheter or sheath. The device includes a proximal end, a distal end, a tapered tip at the distal end, and at least one longitudinal lumen extending along a longitudinal axis, with a first imaging element disposed in the lumen and a first ultrasound transducer located at an outer periphery of the tapered tip to provide forward-directed imaging from the distal end including the tapered tip and a most distal portion of the elongate body.
The device is configured to forwardly guide the device from a point of entry through tissue of a human body to a target site during use. A removable introducer needle is disposed at an end-on aperture within the distal tip and is within the forward-directed imaging zone of the ultrasound transducer during use, and the introducer needle and the device are configured to be introduced into the human body substantially simultaneously so the introducer needle punctures proximate to the target site and directly accesses and punctures the target site including an internal body wall under the ultrasound forward-directed imaging guidance.
In additional embodiments, the device integrates ultrasound imaging and interventional access features including interventional tools associated with biopsy and retrieval instruments, optional interchangeable ultrasound transducers within a sheath, and imaging using fiber optic imaging. The ultrasound transducer configurations may include phased arrays or small ultrasound transducer elements, and the device may include layers for matching and/or backing to reduce deflection. The invention also includes positioning features such as an anchoring portion slidably movable along a length of the elongate body that locks into detents to secure the device at a desired position within the human body.
Claims Coverage
The partial content includes four independent claims. Each independent claim centers on an elongate body without an exterior delivery catheter/sheath, a tapered distal tip, a forward-directed ultrasound imaging system positioned at the outer periphery of the tapered tip, and an introducer needle or needle configured for puncturing and direct access under forward-directed ultrasound imaging guidance, with additional independent structural features including anchoring portions with detents, secure-fit groove/ridge interfaces, and a buffer-element separation arrangement with a single lumen.
Elongate body without exterior delivery catheter/sheath with tapered tip and forward-directed ultrasound transducer imaging
An elongate body having no exterior delivery catheter or sheath, configured to facilitate entry through skin tissue, with a tapered tip at the distal end, at least one longitudinal lumen, and a first imaging element including a first ultrasound transducer located at an outer periphery of the tapered tip, configured to provide forward-directed imaging from the distal end including the tapered tip, and configured to forwardly guide the device from a point of entry to a target site.
Removable introducer needle introduced substantially simultaneously under forward-directed ultrasound imaging guidance
A removable introducer needle disposed at an end-on aperture within the distal tip of the tapered tip, within the forward-directed imaging zone of the ultrasound transducer, wherein the introducer needle and the device are introduced into the human body substantially simultaneously during use, and the introducer needle is configured under ultrasound forward-directed imaging guidance to puncture proximate to the target site and directly access and puncture the target site via the forward-directed imaging zone.
Anchoring portion movable and lockable into detents for securing position during use
An anchoring portion slidably movable along a length of the elongate body and further configured to lock into place at one of a plurality of detents along an outer surface of the elongate body to secure the device at a desired position within the human body during use.
Groove and ridge secure-fit between imaging housing and lumen
At least one of the longitudinal lumens having a groove extending along a length, and a first imaging element disposed in a housing having a ridge extending along a length configured for slidable insertion into the lumen, wherein the ridge on the housing joins with the groove in the lumen to provide a secure fit of the housing into the lumen.
Single longitudinal lumen with needle puncturing and forward-directed imaging zone separated by buffer element
An elongate body having a single longitudinal lumen, a needle situated within the single lumen with an end configured to extend from an end-on aperture at a most distal tip of the elongate body to puncture a human body wall proximate to the target site and directly access the target site, and a first imaging element disposed at an outer periphery of the tapered tip with a housing distal end separated from a proximal end of the needle by at least one buffer element, the first imaging element providing a forward-directed imaging zone for imaging forward navigation from entry to the target site.
Across the independent claims, the inventive coverage is directed to an elongate, catheter-free-entry/tapered-tip device with a forward-directed ultrasound transducer positioned at the outer periphery of the tapered tip to image and guide access to a target site, including substantially simultaneous needle introduction and puncturing under ultrasound forward-directed imaging guidance. Additional claim-specific structure includes an anchoring portion that locks into detents, a groove/ridge secure-fit for an imaging housing inserted into a lumen, and a single-lumen needle arrangement with a buffer-element separation from the imaging housing to provide forward navigation imaging.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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