Multiple angle needle guide

Details Multiple angle needle guide Multiple angle needle guide

1998-10-05

2001-03-20

Jaworski, Francis J. (Department: 3737)

Surgery

Diagnostic testing

Detecting nuclear, electromagnetic, or ultrasonic radiation

Reexamination Certificate

active

06203499

ABSTRACT:

This invention relates to a needle guide, in particular, to a multiple angle needle guide that consistently guides a needle into a scan plane of an ultrasonic diagnostic imaging system probe.
Ultrasonic diagnostic imaging systems are in widespread use for performing ultrasonic imaging and measurements of the human body through the use of probes which may be placed internal or external to the body being measured. Such probes are used to view the internal structure of a body by creating a scan plane. The scan plane is produced from an array of transducers that transmit pulses or beams of energy into the body and receive returning pulses of energy as they are reflected from internal structures of the body. The scan plane is essentially the field of view inside the body being measured. The scan plane is displayed on the display of an imaging system and may have a variety of shapes. The most common scan planes are sector, rectangular (linear), or trapezoidal shaped, where the shape depends upon the type of transducer used in the probe.
Scan planes created by a one dimensional transducer array or a swept beam have two dimensions. For example, the first dimension is the area covered by the scan plane itself. The second dimension is the thickness or elevation dimension of the scan plane as it covers a certain area. Scan planes may be focused or shaped to obtain better resolution of a target or the region around the target (the “region of interest”). As a scan plane is focused, it is well known that the thickness or elevation dimension of the scan plane will become smaller. Focusing or shaping of a scan plan may be accomplished by using a lens or a contoured reflector, by using a curved array transducer, or by using a multi-element or phased array transducer in which the elements of the transducer are energized in a certain progressive pattern to create the desired shape of the scan plane.
Certain medical examinations, such as biopsies, benefit from the use of an imaging system. In such examinations, a needle, such as a biopsy needle, is inserted into a patients body for the purpose of extracting tissue samples, cellular materials, or fluids from a target, such as a cyst. The imaging system is used to view the region of interest, to detect the location of the needle while it is within the region of interest, and to provide feedback to the user so the needle can be better maneuvered.
In a typical biopsy examination the region of interest must first be located within the scan plane and displayed on the imaging system display. A user may then insert a needle, with or without a needle guide, into the body being examined. As the needle enters the scan plane of the probe, the energy pulses from the transducer array are reflected from the needle and returned to the transducer array. A display of the needle in relation to the region of interest will now be shown on the imaging system display. The user may continuously monitor the display to detect and maneuver the location of the needle in relation to the target within the region of interest. The needle, however, must be within the scan plane of the probe to be detected and displayed.
The insertion of a needle without a needle guide may be referred to as the freestyle technique. An advantage of the freestyle technique is the ability of the user to freely change the angle of the needle both before and after the needle has been inserted in the body being examined. The angle of the needle can be changed while it is inserted in the body being examined by backing the needle out of the body without removing the needle completely, re-adjusting the angle of the needle, and then applying a downward pressure on the needle to change its path to the newly selected angle.
The freestyle technique, however, has some drawbacks because it is difficult to insert the needle within the scan plane so the needle is detected by the transducer array. Even if the needle falls within the scan plan upon initial insertion, it is difficult to keep the needle completely within the scan plan during an examination. It is particularly difficult to keep the needle within the scan plane if the region of interest is at a greater depth within the body being examined because the thickness or elevation dimension of the scan plan will become smaller as the beam becomes focused at the target
Each time an inserted needle fails to fall within the scan plane upon initial insertion or falls outside of the scan plane after needle insertion, the needle must be backed out fully or partially, and then re-inserted into the body until the needle is located within the scan plane. Such re-insertions may cause discomfort in the patient being examined and may also frustrate the user causing delay and further discomfort to the patient. Also, a high degree of skill and eye-hand coordination are required to properly maneuver the needle with the freestyle technique. For example, if the examination is an aspiration of fluids from a target such as a cyst, the target will typically shrink in size as the fluids are extracted. Since the needle must be continually relocated as the target shrinks, the required skill level increases as the size of the target decreases.
Needle guides have been used to resolve the difficulties associated with the freestyle technique, particularly the difficulty of inserting the needle within the scan plane such that the needle is detected by the transducer array. Existing needle guides attempt to resolve such difficulties by confining the needle to one pre-selected path of travel such that upon initial insertion, the needle will fall within the scan plane. Such needle guides, however, have not resolved the difficulty of keeping the needle completely within the scan plan because the needle may fall outside of the scan plane due to movement of the needle within the needle guide itself after it has been inserted. Moreover, such difficulties are amplified as the thickness or elevation dimension of the scan plane decreases. Existing needle guides have also eliminated advantages of the freestyle technique such as being able to select multiple angles of insertion and to freely maneuver and change angles of the needle once it has been inserted into the body being examined.
Fixed angle needle guides also make it difficult to reach certain target areas because a user is limited in needle movement. For example, in breast tissue biopsies, a target such as a cyst may be located close to the surface of the breast. In such cases, the needle must be inserted at a shallow angle such that it is almost parallel to the surface of the body being examined. The user may puncture a lung or even the heart of a patient during a breast biopsy if the needle is inserted at a steep angle, such as forty-five degrees. Since fixed angle needle guides typically provide insertion angles that are at a steep angle in relation to the surface of the body being examined, some fixed angle needle guides may increase the risk of injury in such examinations.
Moreover, existing needle guides are often bulky and cumbersome and present problems when a needle must be released from the probe in a quick and easy manner. When a needle is attached to a probe, or to a probe holding device, and the probe is firmly placed against the patient, a sudden movement by the patient may cause internal tissue damage from the needle if the needle is not immediately released from the probe. In an attempt to provide a quick and easy release of the needle, needle guides with quick release handles were provided to quickly remove the needle from the probe. Such devices, however, tend to be bulky, cumbersome, and difficult to operate. Thus, removal of the needle from the probe is not always quick and easy with existing needle guides.
Existing fixed angle needle guides that are designed to insert the needle into the scan plane do not always position the needle completely within the scan plane of the probe as designed. For example, if the dimensions of the needle guide pieces, the probe, or the needle itself are not constructed within tight manufac

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