Calibration method for an automated surgical biopsy device

• US 20040054299A1
• Filed: 05/02/2003
• Published: 03/18/2004
• Est. Priority Date: 07/20/2001
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Brian W. Schmidt, Daniel F. Dlugos, John A. Hibner, Mark A. Burdorff, Scott A. Gleason
• Inventors: Hibner, John A., Dlugos, Daniel F., Burdorff, Mark A., Gleason, Scott A., Schmidt, Brian W.
• Granted Patent: US 7,510,534 B2
• Time in Patent Office: Days
• US Class Current: 600/564
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

A method is provided for calibrating a surgical biopsy system. The biopsy system includes a biopsy instrument and control unit. The biopsy instrument includes a piercer, rotatable cutter, and a port for receiving tissue samples. The method comprises the steps of translating the cutter distally until the translation of the cutter is stopped at an extended position and recording the extended position. The cutter is then translated from the extended position proximally until the translation of the cutter is stopped at a retracted position proximal to the extended position. The retracted position is recorded. The method further comprises the step of rotating the cutter to a rotation speed while the cutter is located at the retracted position and, if determined that the rotation speed is within a predetermined rotation speed range, a feedback signal is provided on the display allowing the operator to progress to the next procedural step.

Claims

1. A method for calibrating a surgical biopsy system, said surgical biopsy system comprising a biopsy instrument and a control unit, said biopsy instrument comprising an elongated, hollow piercer, a cutter rotatably and axially positionable relative to said piercer, a port in said piercer for receiving tissue samples, said surgical biopsy system comprising a control unit and a display for providing feedback signals to an operator, said method comprising the steps of:

a) translating said cutter distally until translation of said cutter is stopped at an extended position;

b) recording said extended position;

c) translating said cutter from said extended position proximally until translation of said cutter is stopped at a retracted position proximal to said extended position;

d) recording said retracted position.

2. The method of claim 1 further comprising the step of providing a first feedback signal to the operator when said cutter travel exceeds a first distance greater than a first predetermined value while moving to said extended position.

3. The method of claim 1 further comprising the step of providing a second feedback signal to the operator when said cutter travel exceeds a second distance greater than a second predetermined value while moving from said extended position to said retracted position.

4. The method of claim 1 further comprising the step of measuring a longitudinal displacement between said retracted position and said extended position, determining if said longitudinal displacement is within a third predetermined range, and providing a third feedback signal to the operator when said longitudinal displacement is not within said third predetermined range.

5. The method of claim 1 further comprising the step of recording said retracted position in said control unit each time said cutter is subsequently moved to said retracted position.

6. The method of claim 1 wherein said biopsy instrument is hand manipulatable.

7. The method of claim 1 wherein said biopsy instrument is detachably fixed to an imaging machine.

8. The method of claim 2 wherein said first predetermined value is about 5.25 inches.

9. The method of claim 3 wherein said second predetermined value is about 5.10 inches.

10. The method of claim 4 wherein said third predetermined range is about 5.025+/−

0.075 inches.

11. A method for calibrating the rotation of a cutter of a surgical biopsy system, said surgical biopsy system comprising a biopsy instrument and a control unit, said biopsy instrument comprising an elongated, hollow piercer, a cutter rotatably and axially positionable relative to said piercer, a port in said piercer for receiving the tissue sample, said surgical biopsy system comprising a control unit and a display for providing feedback signals to an operator, said method comprising the steps of:

a) rotating said cutter to a rotation speed while said cutter is located at said retracted position;

b) determining if said rotation speed is reached and maintained within a fixed time interval;

c) providing on said display a fourth feedback signal allowing the operator to progress to the next procedural step when said rotation speed meets predetermined parameters.

12. The method of claim 11 further comprising the step of providing a fifth feedback signal to the operator when said rotational speed is not within said predetermined parameters.

13. The method of claim 11 wherein said biopsy instrument is hand manipulatable.

14. The method of claim 11 wherein said biopsy instrument is detachably fixed to an imaging machine.

15. The method of claim 11 wherein said fixed time interval is about three seconds.

16. The method of claim 11 wherein said rotation speed is about 200 revolutions per minute.

17. A method for determining that the correctly sized biopsy instrument has been selected by an operator for a surgical biopsy system, said surgical biopsy system comprising a biopsy instrument and a control unit, said biopsy instrument comprising an elongated, hollow piercer, a cutter rotatably and axially positionable relative to said piercer, a port in said piercer for receiving tissue samples, said surgical biopsy system comprising a control unit and a display for providing feedback signals to an operator, said method comprising the steps of:

a) translating said cutter distally until translation of said cutter is stopped at an extended position;

b) recording said extended position

c) translating said cutter from said extended position proximally until translation of said cutter is stopped at a retracted position proximal to said extended position;

d) recording said retracted position;

e) computing in said control unit total distance traveled between said retracted position and said extended position by said cutter;

f) providing on said display a feedback signal to the operator when said total distance traveled falls outside a predetermined range.