Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1998-03-30
2003-09-30
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
Reexamination Certificate
active
06626850
ABSTRACT:
FIELD OF THE INVENTION
This invention generally relates to biopsy instruments. More specifically, this invention relates to automated biopsy instruments especially useful for improving minimally invasive medical procedures to obtain soft tissue biopsy samples.
BACKGROUND OF THE INVENTION
A soft tissue biopsy procedure is a medical procedure for removing a soft tissue sample from a human or animal. The tissue sample can be analyzed to assist a medical professional in formulating a diagnosis. The biopsy procedure is a minimally invasive procedure for obtaining the tissue sample.
The biopsy procedure can be performed utilizing various techniques and devices. Typically, a biopsy device includes an inner stylet slidably positioned inside an outer cannula. The stylet is a solid, pointed needle having a tissue sampling recess, and the cannula is a hollow, open ended needle having a sharp tip. The stylet and the cannula are manipulated to capture a tissue sample in the sample recess. Existing biopsy devices include manual, semi-automated, and automated devices.
Manual biopsy devices allow for manual movement of the stylet and the cannula. Initially, the stylet and the cannula are inserted into soft tissue with the cannula covering the stylet tissue recess. Next, the stylet is manually advanced into the soft tissue to expose the tissue recess and to allow tissue to prolapse into the recess. The cannula is then manually advanced to sever the tissue and capture a tissue sample within the recess. Next, the stylet or the entire the biopsy device is withdrawn from the patient and the tissue sample removed from the recess.
Existing manual biopsy devices have exhibited drawbacks. For example, manual devices require the use of two hands to advance the stylet while holding the cannula in position, and to hold the stylet in position while advancing the cannula. This biopsy technique requires great manual dexterity and coordination. Further, the cutting speed of the manually advanced cannula is quite slow which may result in a poor quality tissue sample.
Existing semi-automatic biopsy devices provide stylet and cannula advancement motions similar to manually operated devices. After the stylet is manually advanced, the semi-automatic devices typically include a compression spring that advances the cannula to capture a tissue sample. The semi-automatic devices still require manual manipulation of the stylet.
Existing automatic biopsy devices also provide stylet and cannula advancement motions to capture a tissue sample in a stylet sample recess. The automatic devices generally include two compression springs to advance the stylet and the cannula. A first compression spring advances the stylet forward after a firing button is depressed. A second compression spring subsequently advances the cannula forward to sever and capture a tissue sample. Existing automatic devices have exhibited drawbacks. For example, automatic devices have required the use of two hands to cock the device (compress the springs). One device purports to be cockable with a single hand; but, the hand must change positions after cocking the cannula in order to cock the stylet. Changing hand positions is cumbersome and encourages two handed cocking. Additionally, as a compression spring expands, the spring force decreases. As the spring force decreases, the stylet and cannula speeds decrease, which may compromise the quality of the tissue sample. Also, existing automatic devices have provided insufficient time to allow the tissue to relax into the sample recess. Consequently, the size of the tissue sample may be reduced.
Existing biopsy devices have been designed to be either reusable or disposable. The reusable devices include a reusable handle and disposable needle assemblies. The stylet and cannula are removable from the handle and disposable with a new stylet and cannula. The handle can be cleaned and re-sterilized after use and thus, is reusable. Disposable devices include a permanent stylet and cannula and are not re-sterilizable. Accordingly, disposable devices are used on a single patient and then discarded.
Examples of existing biopsy devices are disclosed in U.S. Pat. Nos. 4,600,014; 4,944,308; 4,958,625; 5,368,045; and Re34,056. A reusable automatic device containing a single spring for stylet and cannula advancement is disclosed in U.S. Pat. No. 5,121,751.
Therefore, needs exist to improve biopsy devices. Particularly, needs exist to improve automated biopsy instruments especially useful for minimally invasive medical procedures to obtain soft tissue biopsy samples. The present invention satisfies these and other needs to improve biopsy devices.
Other aspects and advantages of the present invention will become apparent after reading this disclosure, including the claims, and reviewing the accompanying drawings.
SUMMARY OF THE INVENTION
The present invention provides automated biopsy instruments especially useful for improving minimum invasive medical procedures to obtain soft tissue biopsy samples. The biopsy instruments provide side-by-side actuators which retract a stylet and a cannula in specific sequences. The retraction sequences include cannula retraction with subsequent stylet retraction, and simultaneous cannula and stylet retraction. The side-by-side design of the cannula and stylet actuators allow the biopsy instrument to be operated with a single human hand without repositioning the hand
The biopsy instruments may include a single spring or two springs to sequentially fire the stylet and the cannula. A constant force spring is utilized in the single spring embodiment. The single spring embodiment also includes an engagement mechanism connected to the constant force spring. The engagement mechanism first fires the stylet, initiates concurrent cannula firing, and then completes cannula firing. The biopsy device provides a time delay to allow tissue to more effectively prolapse into the stylet tissue sample recess.
A safety cover is also provided to prevent accidental firing of the biopsy instrument.
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Chau Sonny
Como-Rodriguez Jan
Kupec Thomas
Allegiance Corporation
Hindenburg Max F.
Rozycki Andrew G.
Wingood Pamela L
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