Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2000-05-17
2001-12-11
Thaler, Michael H. (Department: 3731)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06328701
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an improved biopsy needle specially suited for use in a biopsy gun, or for use as a surgical instrument.
BACKGROUND OF THE INVENTION
Biopsy needles, as part of a biopsy system, are generally used in the medical field to remove tissue, cells or fluids from a body for examination. Known biopsy needles have at least one inner needle (stylet) and an outer needle (cannula). The stylet has a point to enable insertion of the needle into a body, and a recess or notch located near its distal end for receiving a tissue sample. The cannula is displaceably guided on the stylet and has sharp cutting edges. Both the stylet and cannula have a connecting element on their proximal ends to enable connection of the needle to the slides of a biopsy gun. The connecting elements in known biopsy needles generally have included either flanges that cooperate with matching contact surfaces on the slides, or recesses that engage a rib located on a slide wherein both the slide and the rib run along the length of the biopsy needle.
Some prior art biopsy needles have the disadvantage that it is sometimes difficult to insert them into the biopsy gun under sterile conditions. Some prior art biopsy guns require a certain spacing between the connecting elements on the stylet and cannula in order for the biopsy needle to be inserted into the biopsy gun. However, this task of inserting the biopsy needle into the biopsy gun while the connecting elements are maintained in a fixed orientation is difficult because the stylet is generally freely displaceable in the cannula. Therefore, it is generally necessary to align the connecting elements of the biopsy needle, either manually or through use of a separate spacer, prior to insertion into a biopsy gun. After the biopsy needle is inserted into a biopsy gun, if a spacer clip is used, it is generally necessary to remove the spacer in order to close the lid and operate the biopsy gun. Conventional spacer clips require the molding of a separate spacer. This requirement of a separate molding step adds an additional step in the manufacturing and packaging process thereby increasing the costs to produce the biopsy needle. Moreover, the use of a separate spacer clip may require undue handling of the needle in order to connect and disconnect the spacer clip. Furthermore, some conventional biopsy guns do not permit the option of inserting the needle into a biopsy gun in the uncocked position. By permitting a biopsy needle to be inserted in an uncocked biopsy gun, the proper operation of the needle is checked prior to the gun being fired by moving the inner needle and the outer needle relative to each other during the cocking process. An additional disadvantage of some conventional biopsy needles is that under some conditions, the individual connecting elements slip or rotate relative to the slides they are carried on when inserted in a biopsy gun.
SUMMARY OF THE INVENTION
The present invention includes a biopsy needle particularly suited for use in a biopsy gun. Additionally, the present invention can also be used as a surgical instrument for procedures such as, a microlumpectomy and the removal of microcalcification. The biopsy needle made according to the present invention includes a guiding needle holder that is an integral part of the needle itself that is not removed prior to needle use. The guiding needle holder provides not only an integrated means for grasping and handling the needle, but facilitates needle alignment without the use of extrinsic devices, and prevents rotation and other movement of the needle relative to itself and the slides in a biopsy gun. Additionally, the integrated design of the needle allows the needle to be easily prepackaged in a sterile, disposable condition.
The biopsy needle of the present invention comprises an inner needle with a recess near its beveled distal end, an outer needle displaceably guided on the inner needle and having a beveled distal end, and a guiding needle holder. The gauge and length of the inner needle and outer needle varies with the procedure for which it will be used. The guiding needle holder includes first and second connecting elements, and an integrated spacer. The first connecting element is displaceably guided along the length of the integrated spacer, and the second connecting element is fixedly engaged with the proximal end of the integrated spacer. Both the first and second connecting elements contain a raised annular flange that defines a portion of a bore though the connecting element and assists in maintaining the connecting elements in engagement with the integrated spacer. These bores in the connecting elements allow the needle to be mounted on posts extending from the slides of a biopsy gun. It should be noted that these bores are illustrative of only one way to connect the needle to the slides of a biopsy gun and that other arrangements may be used. The inner needle is embedded in the second connecting element and the outer needle is embedded in the first connecting element. When the first and second connecting elements are maximally displaced relative to each other within the integrated spacer, the distance between the raised annular flange in the first connecting element and the raised annular flange in the second connecting element is such that the biopsy needle can be inserted with the proper spacing into a biopsy gun in the cocked position. This eliminates the need for any external means of achieving the proper spacing of the needle. Alternatively, the needle can be mounted in a biopsy gun in the uncocked position.
Additionally, the present invention can be used to take multiple samples at the same biopsy site as required by procedures such as computer tomography by removing the connecting element carrying the inner needle and replacing it with another connecting element and an inner needle. Once the body is pierced, the biopsy needle is inserted into a biopsy gun and the sample taken. The needle is then removed from the body and the biopsy gun, the sample removed, and the needle can then be reused. All this is accomplished without the use of an external spacer.
In an alternative embodiment, the guiding needle holder incorporates an integrated spacer and a single connecting element. The inner needle is embedded in the integrated spacer and the outer needle is embedded in the connecting element. The biopsy needle can be positioned for insertion into a biopsy gun either in the cocked or uncocked position by maximizing the displacement of the connecting element. In this embodiment, multiple samples can be taken by dislodging the integrated spacer, removing the inner needle and replacing it with another inner needle. The integrated spacer can either be reused or replaced.
It is therefore an advantage of the present invention to provide a biopsy needle that allows a tissue sample to be obtained from a tissue mass which automatically captures and allows the removal of a tissue sample for examination, wherein the inner needle and the outer needle reside and function in an integrated spacer.
It is a further advantage of the present invention to provide an integrated spacer or guiding needle holder that does not require the spacer to be removed prior to operating a biopsy gun.
It is a further advantage of the present invention to provide an integrated spacer that remains inside a biopsy gun during the operation of the gun.
It is a further advantage of the present invention to provide an integrated spacer for a biopsy needle which allows single-handed loading and removal of the needle from a biopsy gun while maintaining the orientation and rotational position of the inner needle and outer needle of a biopsy needle relative to each other and the biopsy gun.
It is a further advantage of the present invention to provide a biopsy needle available in multiple needle gauges and lengths, tailored for various biopsy procedures.
It is a further advantage of the present invention to provide a biopsy needle including an integrated spacer which allows the insertion of t
Mayer, Brown & Pratt
Medical Device Technologies, Inc.
Thaler Michael H.
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