Biopsy device having rotational cutting

• US 8,690,793 B2
• Filed: 03/16/2009
• Issued: 04/08/2014
• Est. Priority Date: 03/16/2009
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ranpura, Himanshu M., Jensen, Angela K., Guillory, Kenneth Shane
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US13/254,109
• Publication Number:
  US 20110313316A1
• Time in Patent Office: 1,849 Days
• Field of Search: 600/562, 600/564, 600/565, 600/566, 600/567, 600/568
• US Class Current: 600/562
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

A biopsy device includes a probe assembly and a driver unit. The probe assembly includes a first cannula having a first aperture extending to a lumen proximal to a first distal end of the first cannula. A second cannula has a second aperture extending to a lumen proximal to the second distal end of the second cannula. The second cannula is disposed co-axially with the first cannula. A least one of the first aperture and the second aperture has a cutting edge. The driver unit is configured for releasably mounting the probe assembly. The driver unit is operatively configured to simultaneously rotate the first cannula and the second cannula at different rotational velocities so that the first aperture and the second aperture periodically come into alignment to form a virtual tissue sample aperture.

Claims

1. A biopsy device, comprising:

a probe assembly including;

a first cannula having a first side wall defining a first lumen, said first cannula having a first proximal end and a first distal end, said first cannula having a first aperture extending through said first side wall to said first lumen proximal to said first distal end, said first cannula having a longitudinal axis, and

a second cannula having a second side wall defining a second lumen, said second cannula having a second proximal end and a second distal end, said second cannula having a second aperture extending through said second side wall to said second lumen proximal to said second distal end, said second cannula being disposed co-axially with said first cannula,

at least one of said first aperture and said second aperture having a cutting edge; and

a driver unit configured for releasably mounting said probe assembly, said driver unit being operatively configured to simultaneously rotate said first cannula and said second cannula in opposite rotational directions at different rotational velocities so that said first aperture and said second aperture periodically come into alignment to form a virtual tissue sample aperture.

2. The biopsy device of claim 1, said first cannula being an outer cannula having a needle tip located at said first distal end, and said second cannula being an inner cannula positioned in said first lumen of said outer cannula, said biopsy device further comprising a vacuum source in fluid communication with the inner cannula to pull tissue by negative pressure into said inner cannula each time said virtual tissue sample aperture is formed, said first aperture and said second aperture cooperating to sever said tissue that is pulled into said inner cannula as said virtual tissue sample aperture is closed by continued rotation of said outer cannula and said inner cannula.

3. The biopsy device of claim 1, wherein said virtual tissue sample aperture is formed at a plurality of angular radial positions relative to said longitudinal axis during a biopsy procedure by continuous simultaneous rotation of both of said first cannula and said second cannula.

4. The biopsy device of claim 3, wherein said second cannula is positioned in said first lumen of said first cannula, said biopsy device further comprising a vacuum source in fluid communication with the second cannula to provide a supply of negative pressure in said second lumen of said second cannula, and wherein during a biopsy procedure each time said virtual tissue sample aperture is formed tissue is pulled into said second lumen of said second cannula, and thereafter said first aperture and said second aperture cooperating to sever said tissue that is pulled into said inner cannula as said virtual tissue sample aperture is closed by said continuous simultaneous rotation of said first cannula and said second cannula, each tissue sample so severed being transported through said second lumen of said second cannula by said negative pressure to a tissue sample receptacle.

5. The biopsy device of claim 4, said driver unit including a controller configured to execute a velocity profile that provides a variable rotational velocity for at least one of said first cannula and said second cannula during said continuous simultaneous rotation of said first cannula and said second cannula.

6. The biopsy device of claim 5, wherein said velocity profile provides an increase in velocity of at least one of said first cannula and said second cannula as said virtual tissue sample aperture begins to close to sever said tissue.

7. The biopsy device of claim 5, wherein said velocity profile provides an equal magnitude of velocity for said first cannula and said second cannula as said virtual tissue sample aperture begins to close to sever said tissue.

8. The biopsy device of claim 5, wherein said velocity profile provides a change in rotational velocity of at least one of said first cannula and said second cannula to define a next angular radial position of a next formation of said virtual tissue sample aperture.

9. The biopsy device of claim 1, said driver unit including a controller configured to execute a velocity profile that provides a variable rotational velocity for at least one of said first cannula and said second cannula during the simultaneous rotation of said first cannula and said second cannula.

10. The biopsy device of claim 9, wherein said velocity profile provides an increase in rotational velocity of at least one of said first cannula and said second cannula as said virtual tissue sample aperture begins to close.

11. The biopsy device of claim 9, wherein said velocity profile provides an equal magnitude of velocity for said first cannula and said second cannula as said virtual tissue sample aperture begins to close.

12. The biopsy device of claim 9, wherein said velocity profile provides a change in rotational velocity of at least one of said first cannula and said second cannula to define a next angular radial position of a next formation of said virtual tissue sample aperture.

13. The biopsy device of claim 1, said driver unit including:

a first drive mechanism configured for drivable engagement with the first cannula to rotate said first cannula at a first rotational velocity in a first rotational direction; and

a second drive mechanism configured for drivable engagement with the second cannula, said second drive mechanism being configured to rotate said second cannula at a second rotational velocity different from said first rotational velocity in a second rotational direction, opposite to said first rotational direction, simultaneously with the rotation of said first cannula.

14. The biopsy device of claim 13, wherein said first drive mechanism and said second drive mechanism has a motor associated therewith, said driver unit further including a controller communicatively coupled to said motor, said controller being configured to control said motor to effect rotation of said first cannula in accordance with a first velocity profile and to effect rotation of said second cannula in accordance with a second velocity profile.

15. The biopsy device of claim 13, wherein said first driving mechanism has a first motor and said second driving mechanism has a second motor, said driver unit further including a controller communicatively coupled to said first motor and said second motor, said controller being configured to control said first motor to effect rotation of said first cannula in accordance with a first velocity profile and to control said second motor to effect rotation of said second cannula in accordance with a second velocity profile.

16. The biopsy device of claim 1, comprising:

a first gear fixedly attached to said first cannula for rotation about said longitudinal axis;

a second gear fixedly attached to said second cannula for rotation about said longitudinal axis; and

said drive unit including;

a first gear drive mechanism engaged said first gear;

a second gear drive mechanism engaged with said second gear;

a motor drivably coupled to each of said first gear drive mechanism and said second gear drive mechanism; and

a controller communicatively coupled to said motor, said controller being configured to control said motor to effect rotation of said first cannula in accordance with a first velocity profile and to effect rotation of said second cannula in accordance with a second velocity profile.

17. The biopsy device of claim 1, wherein a longitudinal extent of said first aperture is parallel to said longitudinal axis, and a longitudinal extent of said second aperture is parallel to said longitudinal axis, such that a maximum opening size of said virtual tissue sample aperture is equal to the smaller of a respective opening size for each of said first aperture and said second aperture.

18. The biopsy device of claim 17, wherein at least said first aperture is elliptical and said cutting edge is formed along said longitudinal extent of said first aperture.

19. The biopsy device of claim 1, wherein a longitudinal extent of said first aperture is angled in a first direction relative to said longitudinal axis, and a longitudinal extent of said second aperture is angled in a second direction relative to said longitudinal axis that intersects said first direction, such that a maximum opening size of said virtual tissue sample aperture is less than an opening size of either of said first aperture and said second aperture.

20. The biopsy device of claim 19, wherein said cutting edge is formed along said longitudinal extent of said first aperture.

21. A biopsy device, comprising:

a probe assembly including;

a first cannula having a first side wall defining a first lumen, said first cannula having a first proximal end and a first distal end, said first cannula having a first aperture extending through said first side wall to said first lumen proximal to said first distal end, said first cannula having a longitudinal axis, and

a second cannula having a second side wall defining a second lumen, said second cannula having a second proximal end and a second distal end, said second cannula having a second aperture extending through said second side wall to said second lumen proximal to said second distal end, said second cannula being disposed co-axially with said first cannula,

at least one of said first aperture and said second aperture having a cutting edge; and

a driver unit configured for releasably mounting said probe assembly, said driver unit being operatively configured to rotate said first cannula in accordance with a first velocity profile and said second cannula in accordance with a second velocity profile to periodically align said first aperture and said second aperture to form a virtual tissue sample aperture at a plurality of angular radial positions relative to said longitudinal axis during a biopsy procedure by continuous simultaneous rotation of both of said first cannula and said second cannula.

22. The biopsy device of claim 21, wherein said first cannula and said second cannula are rotated in opposite rotational directions.

23. The biopsy device of claim 21, wherein said second cannula is positioned in said first lumen of said first cannula, said biopsy device further comprising a vacuum source in fluid communication with the second cannula to provide a source of negative pressure in said second lumen of said second cannula, and wherein during said biopsy procedure each time said virtual tissue sample aperture is formed tissue is pulled into said second lumen of said second cannula, and thereafter said first aperture and said second aperture cooperating to sever said tissue that is pulled into said inner cannula as said virtual tissue sample aperture is closed by said continuous simultaneous rotation of said first cannula and said second cannula, each tissue sample so severed being transported through said second lumen of said second cannula by said negative pressure to a tissue sample receptacle.

24. A method for controlling a biopsy device during a biopsy procedure, said biopsy device having a probe assembly with an outer cannula having a distal needle tip and an inner cannula arranged coaxial with said outer cannula with respect to a longitudinal axis, said outer cannula having a first side aperture and said inner cannula having a second side aperture with at least one of said first side aperture and said second side aperture having a cutting edge, and a vacuum source connected in fluid communication with a lumen of said inner cannula and with a tissue sample receptacle, comprising:

positioning each of said outer cannula and said inner cannula at a respective initial rotational position;

inserting said probe assembly in a region of a patient to be biopsied;

establishing continuous simultaneous rotation of said outer cannula in accordance with a first velocity profile and said inner cannula in accordance with a second velocity profile to periodically align said first side aperture and said second side aperture to form a virtual tissue sample aperture at a plurality of angular radial positions relative to said longitudinal axis;

establishing a supply of negative pressure in said lumen of said inner cannula, such that each time said virtual tissue sample aperture is formed tissue is pulled through said virtual tissue sample aperture into said lumen of said inner cannula, thereafter said first side aperture and said second side aperture cooperate to sever said tissue that is pulled into said inner cannula as said virtual tissue sample aperture is closed by said continuous simultaneous rotation of said outer cannula and said inner cannula, each tissue sample so severed being transported through said lumen of said inner cannula by said negative pressure to a tissue sample receptacle; and

ceasing said continuous simultaneous rotation of said outer cannula and said inner cannula after all desired tissue samples have been harvested.

25. The method of claim 24, wherein said outer cannula and said inner cannula are rotated in opposite rotational directions.

26. The method of claim 24, wherein said respective initial rotational position of said outer cannula and said inner cannula is selected such that said first side aperture and said second side aperture are not in alignment such that said virtual tissue sample aperture is not formed prior to insertion of said probe assembly into said patient.

27. The method of claim 24, wherein said continuous simultaneous rotation said outer cannula and said inner cannula is selected to coincide with a final position wherein said first side aperture and said second side aperture are not in alignment, such that said virtual tissue sample aperture is not again formed prior to removal of said probe assembly from said patient.