Patent Application
20050113816
Ultrasound is an established imaging tool for the diagnosis and treatment of human diseases. In addition to pure imaging, ultrasound is used for real time needle guidance that enables accurate targeting of internal structures during interventional procedures such as biopsy, drainage or focal therapies that can be delivered through a needle or small diameter probe. There are two fundamental techniques for ultrasound guided needle placement. The first is the “freehand” method where the ultrasound imaging transducer and needle are separate and independently movable throughout the procedure. In this method the needle and path to the target organ are visualized by a skilled operator who holds the transducer in one hand while advancing the needle with the other. The coordination and visual and spatial orientation skills required to simultaneously maintain the image plane in line with the needle, keep the target in view, maintain orientation to surrounding structures and manipulate the needle are substantial and demanding. It is not a technique that suits everyone and there is a steep and prolonged learning curve. Its major advantage as a technique is the complete versatility allowed by total freedom of movement of both the needle and the ultrasound imaging transducer. The second method is to use a needle guide that has a known orientation to the ultrasound imaging transducer. Such guides may be built into the transducer or come as an accessory that is attached if desired. They have been made as either reusable or single use sterile disposable products. These guides are designed to keep any needle passing through them on a known path in the image plane* *and thus eliminate many of the difficult variables inherent in the freehand technique. Typically, software is supplied by the ultrasound manufacturer that shows a virtual guide path and depth index on the real time image. This method is less reliant on user intuition, skills and experience and has a shorter learning curve, but has several limitations that have hampered universal acceptance:
The present invention relates to a new and original design for a needle guide that efficiently marries the advantages of the freehand technique with the inherently greater control and security of the needle guide technique while addressing the design issues noted above. This guide is open to accept any needle, probe or catheter (i.e. instruments) with diameters including but not limited to all of the common sizes of 27 gauge up to 8.5 French with a vernier type user adjustable “drag” on the instrument. It uses no additional parts and requires only a single push with a finger to very quickly engage or disengage the instrument while maintaining view of the instrument in the image plane. The angle of attack for the instrument in the image plane can be user selected over an angular range by virtue of an arcuate ratcheting mechanism that also can maintain the angle chosen. The “dead space” problem is eliminated by virtue of a curved shoe at the base of the guide. The guide is short in comparison to currently used competing guides and should not compromise needle length. It can be made of single use injection molded parts and by virtue of simplicity and low cost components should be cost competitive. Two different embodiments of this design are shown in the attached
The present invention relates to a needle guide that can be operatively secured to an ultrasound transducer that functions in an in plane relationship to an imaging plane and that has a single cavity for engaging multiple different needle diameters without the requirement for additional parts or attachments. This guide may have a reciprocating mechanism that can securely engage and accurately guide and quickly release a needle, probe or catheter in an imaging plane. The angle of approach in the chosen image plane may be adjusted by the operator before or during a procedure and may be fixed as desired The frictional resistance of the needle to sliding through the guide may be adjustable by the operator. The guide may be made disposable or reusable of a variety of materials for manufacture that may be chosen accordingly.
Referring to
Instrument engaging portion 14 is preferably configured to operatively secure an instrument, such as a biopsy needle, along guide path 22. Engaging portion 14 may comprise first and second engaging portions 24,26. First engaging portion 24 may include at least one surface 28 preferably shaped to accommodate a portion of an instrument. First engaging portion 24 may include a second surface 29 spaced apart along the guide path 22 from surface 28 and preferably shaped to accommodate a portion of the instrument. Second engaging portion 26 preferably includes a surface 30 also preferably shaped to accommodate a portion of the instrument. First and second engaging portions 24,26 may cooperate to operatively secure the instrument. For example, an instrument may be compressed between (a) surface 30 and (b) surface 28 and, optionally, surface 29. In one embodiment, surfaces 28-30 contact the instrument in a three-point contact configuration. Preferably, the first and second portions 24,26 are configured to receive an instrument laterally with respect to the guide path 22.
Engaging portion 14 may be configured to allow motion, for example rotation, of guide path 22. Preferably, guide path 22 may be rotated with respect to securing portion 22. In one embodiment, a rotational motion of guide path 22 is accompanied by a rotational motion of at least one of first and second engaging portions 24,26 so that an orientation of guide path 22 relative to the first and second engaging portions 24,26 does not change as guide path 22 is rotated. An example of this may be seen upon comparing
Referring to
| Number | Date | Country | |
|---|---|---|---|
| 60472749 | May 2003 | US |
