Control system and method for automated biopsy device

• US 5,769,086 A
• Filed: 12/06/1995
• Issued: 06/23/1998
• Est. Priority Date: 12/06/1995
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Biopsys Medical, Inc. (Johnson & Johnson)
• Inventors: Burbank, Fred H., Ritchart, Mark A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/568,143
• Time in Patent Office: 930 Days
• Field of Search: 128/749, 128/751-755, 600/105
• US Class Current: 600/566
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery

Abstract

An automatic control system for a vacuum-assisted automatic core biopsy device (10) is provided, wherein the automatic core biopsy device (10) comprises a housing (12), out of which extends a needle assembly (14) including a hollow outer piercing needle (16), an inner cutter (18) having a lumen (20), a probe housing (22), and a tissue receiving notch (24). The automatic control system (92) is computerized to move the hollow outer piercing needle (16) automatically to the target tissue lesion, as was true in the prior art, but also is programmed to automatically control the rotational orientation of the piercing needle (16), and its associated tissue receiving notch (24), as well as the axial positioning and rotation of the cutting cannula (18). Consequently, a clinician user need only mark the desired locations within the target location from which tissue samples are desired and the automatic control system will operate the device to retrieve samples from the marked locations.

Claims

1. An automatic biopsy device, comprising:

a first elongate cannula having a distal end for entering tissue and a notch located proximally of said distal end for receiving a portion of the tissue which is positioned adjacent to said notch;

a second elongate cannula disposed coaxially with said first cannula, said second cannula being slidable along the first cannula for cutting the portion of tissue protruding into said notch when said second cannula slides past said notch, thereby depositing the portion of cut tissue within said first elongate cannula proximal to said first cannula distal end;

a first driving mechanism for rotationally driving said first cannula about its longitudinal axis, so that said notch may be rotated to any desired orientation for sampling tissue from different locations about said first cannula;

a second driving mechanism for moving said second cannula relative to said first cannula;

a monitor having a screen for displaying a target lesion site to a user;

a processor for receiving instructions from said user regarding regions of said target lesion from which tissue samples are to be taken and for generating instructions responsive to the instructions from said user in order to execute obtainment of tissue samples from said regions; and

a controller for receiving the instructions generated by said processor and for automatically controlling said first driving mechanism to rotate said notch to a desired orientation for obtaining a tissue sample and said second driving mechanism to move said second cannula to cut said tissue sample so that it is deposited within said first cannula.

2. An automatic biopsy device as recited in claim 1, wherein said first elongate cannula comprises an outer hollow piercing needle and said second elongate cannula comprises an inner cutter.

3. An automatic biopsy device as recited in claim 1, and further comprising a housing for containing said first and second driving mechanisms, said housing being attached to a punction arm for moving said housing responsive to control instructions from said processor.

4. An automatic biopsy device as recited in claim 3, wherein said punction arm includes a linear motor on which said housing is mounted and the first cannula extends from said housing, the distal end of the first cannula being positionable in a desired location with respect to said target lesion by movement of said linear motor.

5. An automatic biopsy device as recited in claim 4, wherein said linear motor moves rotationally and axially to position the distal end of the first cannula.

6. An automatic biopsy device as recited in claim 3, and further comprising:

a punction arm power and control unit for receiving instructions from said controller and for driving said punction arm to move said housing; and

a biopsy device power and control unit for receiving instructions from said controller and for driving said first and second driving mechanisms to rotationally move said first cannula and to rotationally or axially move said second cannula.

7. An automatic biopsy device as recited in claim 6, wherein said punction arm is driven to rotationally or axially move said housing.

8. An automatic biopsy device as recited in claim 3, wherein said first driving mechanism comprises a notch orientation drive system including:

a notch orientation motor; and

a notch orientation drive gear rotatably driven by said notch orientation motor.

9. An automatic biopsy device as recited in claim 8, wherein said first driving mechanism further comprises:

a power/control cable for providing electrical power and control signals to said notch orientation motor from a biopsy device power and control unit;

a primary notch orientation gear engaged with and rotatably driven by said notch orientation drive gear and being attached to one end of a rotatable shaft;

a secondary notch orientation gear attached to a second end of said shaft, and being rotatable responsive to rotation of said shaft; and

a notch orientation gear fixedly attached about said first cannula, said notch orientation gear being engaged with and rotatably driven by said secondary notch orientation gear to rotate said first cannula responsive to commands from said biopsy device power and control unit.

10. An automatic biopsy device as recited in claim 3, wherein said second driving mechanism comprises:

a carriage assembly through which said second cannula extends axially;

a cutter drive motor;

a first power/control cable for providing electrical power and control signals to said cutter drive motor from a biopsy device power and control unit;

a cutter power gear rotatably driven by said cutter drive motor;

a cutter gear disposed in said carriage assembly and engaged with and rotatably driven by said cutter power gear, said cutter gear being fixedly attached about said second cannula to rotate said second cannula responsive to commands from said biopsy device power and control unit;

an axial drive engaged with a lower portion of said carriage assembly and adapted to drive said carriage assembly forwardly or rearwardly in an axial direction;

an axial drive motor for rotatably driving said axial drive; and

a second power/control cable for providing electrical power and control signals to said axial drive motor from said biopsy device power and control unit.

11. An automatic biopsy device as recited in claim 1, and further comprising:

a source of vacuum pressure for supplying a vacuum pressure to aspirate said notch and thereby draw tissue into said first cannula proximally of said distal end;

wherein said controller is adapted to control said source of vacuum pressure so that the notch is aspirated as desired.

12. An automatic biopsy device as recited in claim 1, and further comprising a user input device for defining, on said monitor screen, portions of said target lesion site from which tissue samples are to be taken, and thereby providing said instructions to the processor.

13. An automatic biopsy device as recited in claim 12, wherein said monitor screen has a movable cursor thereon and said portions are defined by dragging said cursor through said target region to shade the portions, whereupon the processor calculates necessary points from which tissue samples must be taken to effectively sample all of the shaded portions.

14. An automatic biopsy device as recited in claim 12, wherein said monitor screen has a movable cursor thereon and said portions are defined by dragging said cursor to a plurality of desired points within the target region and clicking on the desired points, thereby instructing the processor to obtain a tissue sample from each desired point in order to effectively sample the entire target region.

15. An automatic biopsy device as recited in claim 1 wherein said first cannula may receive and process a plurality of tissue samples sequentially without retraction from the target lesion.

16. An automatic biopsy device as recited in claim 1, wherein said monitor and said processor comprise elements of a computer system.

17. An automatic biopsy device as recited in claim 15, wherein said controller comprises a further element of said computer system.

18. An automatic biopsy device as recited in claim 1, wherein said second driving mechanism axially moves said second cannula relative to the first cannula.

19. An automatic biopsy device, comprising:

a hollow needle having a distal end and a tissue receiving notch;

a cutter having a sharpened distal end and disposed coaxially within said hollow needle;

a first driver for rotating said hollow needle to orient said tissue receiving notch in a desired radial orientation;

a second driver for axially moving said cutter so that it is slidable along the hollow needle for cutting tissue protruding into said notch; and

a processor for receiving instructions from a user related to desired portions of a target lesion to be sampled and instructing a controller to automatically control each of said first and second drivers to move the hollow needle and the cutter in order to obtain the desired tissue lesion portions.

20. An automatic biopsy device as recited in claim 19, and further comprising a third driver for rotationally moving said cutter.

21. A method of controlling an automatic biopsy device said device comprising a first elongate cannula having a distal end for entering tissue and a tissue-receiving notch, and a second elongate cannula having a sharpened distal end and disposed coaxially with the first cannula, the method comprising:

a) providing instructions as to the portions of said lesion from which tissue samples are desired by denoting on a computer monitor screen displaying a target lesion said portions;

b) transmitting said instructions to a processor;

c) processing the instructions and transmitting instructions from said processor to a controller; and

d) using the controller to automatically drive said first cannula to rotate to a desired notch position and to automatically drive said second cannula to cut tissue protruding into said notch, thereby obtaining a tissue sample.

22. The method as recited in claim 21, wherein steps a) through d) are repeated to obtain an additional tissue sample.

23. The method as recited in claim 21, wherein steps c) and d) are repeated to obtain an additional tissue sample.

24. The method as recited in claim 21, wherein step a) is performed by manipulating a user input device to shade said portions on said monitor screen.

25. The method as recited in claim 24, wherein step c) includes calculating particular points within said shaded portions from which tissue samples must be taken to effectively sample the shaded portions, and transmitting the coordinates of said particular points to said controller.

26. The method as recited in claim 21, wherein step a) is performed by manipulating a user input device to denote specific points on said monitor screen from which tissue samples should be taken to effectively sample the target lesion.

27. The method as recited in claim 21, wherein step c) includes transmitting the coordinates of said specific points to said controller.