Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-09-16
2002-03-26
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S464000
Reexamination Certificate
active
06361499
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a needle guide for a medical imaging instrument. More particularly, the invention is directed to a method and apparatus for a needle guide system for use in guiding needles into selected locations of a patient relative to a medical instrument imaging sensor. The needle guide method and apparatus provide improved attachment to the medical imaging sensor, improved access and removability of the needle, and improved insertion of a needle into the needle guide.
BACKGROUND
Imaging instruments, such as ultrasound probes, computed tomography scanners (CT Scanners), and magnetic resonance imagers (MRI) have revolutionized the manner in which many important medical procedures are performed. Each of these medical instruments utilizes non-invasive imaging techniques to explore and assess the condition of sub-dermal tissue. As a result of this non-invasive imaging ability, diagnostic and therapeutic protocol's have been developed that allow for the provision of many highly successful and safe procedures with a minimum of disturbance to patients.
Ultrasound, for example, has received widespread acceptance as a useful diagnostic tool. Ultrasound is particularly well suited for obstetrics, where real-time scanners create a continuous image of a moving fetus that can be displayed on a monitoring screen. The image is created by emission of very high frequency sound waves from a transducer placed in contact with the mother's skin. Repeated arrays of ultrasonic beams scan the fetus and are reflected back to the transducer, where the beams are received and the data transmitted to a processing device. The processing device can analyze the information and compose a picture for display on the monitoring screen. Relative measurements may be made, and the gestational age, size and growth of the fetus can be determined. In some circumstances, a needle is guided into the amniotic fluid in order to retrieve a fluid sample for analysis. These samples can be useful for diagnosing irregular conditions and to indicate that prenatal care is necessary for the fetus.
Ultrasound probes, and other imaging instruments, are also used for a variety of other purposes, such as identifying the existence, location, and size of tumors, as well as the existence of other medical conditions, including the atrophy or hypertrophy of bodily organs. While such imaging techniques are primarily performed on humans, similar techniques are often used by veterinarians to diagnose and treat a wide variety of animals, such as sheep, cows, horses, and pigs.
For many imaging applications, it is desirable that a needle, biopsy instrument, catheter, or other thin instrument be inserted into the body of a patient in order to remove a biopsy sample or to perform other medical procedures. It is normally desirable that the thin instrument or needle be guided to a specific position within the body of the patient. Various guide devices have been designed for assisting in guiding the instrument. Many of these guides are fixed-angle devices with limited functionality because they have limited control over needle placement compared to a needle guide that allows selection of multiple angles. In addition, many of these devices do not permit the placement of more than one needle into a patient at one time or they do not make such multiple placements easy.
Also, certain of these devices do not allow the needle to be easily inserted and removed from the needle guide, particularly while the needle is in the patient. One problem associated with the removal of needles from traditional needle guides is that the needle rotates or undergoes undesirable lateral movement during insertion and removal. Such lateral movement is characterized by movement of the needle parallel to the body surface (i.e., sideways) rather than into and out of the patient. This rotation and movement can be problematic because it alters the location of the needle and can create uncomfortable movement in the needle that is a distraction to patients. Even a small amount of movement is undesirable in many circumstances.
Another significant problem associated with some existing needle guides is that the guide mechanism is attached to the exterior of the imaging instrument by a bracket that wraps around the base of the sensor. These brackets can be quite expensive, adding hundreds of dollars to the cost of the needle guide. While such brackets securely hold the needle guide, they can create problems with maintaining the device in a sterile condition, and are often not well suited to be used with a sterile cover, such as a latex film, placed over the imaging instrument. Such covers are increasingly desirable in order to maintain the ultrasound sensor in a sterile environment. The covers reduce the likelihood of contamination between patients and reduce the cost of medical procedures by minimizing sterilization costs.
One challenge of working with latex and similar polymer based covers is that they have a high coefficient of friction and are subject to binding when in contact with moving pieces of an imaging sensor or needle guide. Such binding can lead to tears or punctures of the cover. For example, some prior art imaging sensors have removable pieces that are frictionally fit over a latex cover. Such designs are problematic because they can be difficult to fit and remove, as well as cause problems with binding and an ensuing risk of tearing. Consequently, a need exists for an improved needle guide system.
Such improved needle guide system should permit a needle to be directed into a patient and be removable from the patient without unnecessary lateral movement or rotation of the needle. The needle guide system should also reduce or eliminate the need for a bracket used to secure the needle guide to the imaging instrument.
SUMMARY OF THE INVENTION
The present invention is directed to a needle guide system for use in guiding a needle into a patient who is undergoing imaging analysis with an imaging instrument. This needle guide system includes a mounting base and a needle guide. In certain implementations, the mounting base is configured to pivot. The pivoting portion of the mounting base is configured to pivot along at least one axis, and the needle guide is removably secured to the pivoting portion of the mounting base. The needle guide has a rotatable needle retainer member configured to securely retain a needle in a slot, while still allowing removal from the guide with minimal rotation and movement.
Specific implementations of the needle guide system of the present invention are designed such that the system may be used with a protective cover placed over the mounting base, thereby enveloping the imaging instrument and the mounting base. The needle guide is configured to be removably secured to the mounting base over the protective cover, without the development of significant kinetic friction between the protective cover and the needle guide during mounting and removal of the needle guide. As such, the needle guide may be placed on the pivoting portion of the mounting base, and removed therefrom, with minimal mechanical stress to the protective cover, thereby preventing holes in the protective cover from developing and maintaining a sterile environment around the imaging instrument.
In other implementations, the needle guide system is designed such that the mounting base is placed over the protective cover. In such implementations, the protective cover is positioned between the mounting base and the imaging instrument. The mounting base is placed on the imaging instrument with minimal stress to the protective cover, which also avoids consequent holes generated from this stress.
In addition, in specific implementations of the present invention, the needle guide system further includes a movable locking member having an unlocked configuration in which the locking member does not apply pressure to the mounting base, while also having a locked configuration in which the locking member does apply pressure to the mounting ba
Bates John D.
Best David W.
Cermak Craig
Schultz David F.
Severence Brett
CIVCO Medical Instruments Inc.
Imam Ali M.
Lateef Marvin M.
Merchant & Gould P.C.
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