Self-contained handheld biopsy needle

• US 8,251,917 B2
• Filed: 08/17/2007
• Issued: 08/28/2012
• Est. Priority Date: 08/21/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Almazan, Dan
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/438,020
• Publication Number:
  US 20100234760A1
• Time in Patent Office: 1,838 Days
• Field of Search: 600562-568, 606/167, 606/170, 606/171, 606/180
• 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 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence

Abstract

A self-contained hand-held biopsy needle has various features relating to automated sampling and recovery. Among the disclosed features are ones suited to fully-disposable single-use automatic biopsy devices, such as light weight, low cost, and simple design.

Claims

1. A biopsy device, comprising:

a housing;

a biopsy needle configured to project from the housing, the biopsy needle having a first member that defines a sample chamber and a second member that defines a sample volume within the sample chamber;

a pump coupled to the biopsy needle, the pump being configured to generate a vacuum in the sample volume;

a prime mover having an output that defines a first drive interval and a second drive interval;

a first transmission configured to be driven by the prime mover during the first drive interval to operate the pump;

a second transmission configured to be driven by the prime mover during the second drive interval, the second transmission being configured to position the first and second members of the biopsy needle to define the sample volume.

2. The device of claim 1, further comprising a housing configured to enclose the pump, the prime mover, the first transmission, the second transmission, and a portion of the biopsy needle.

3. The device of claim 1, wherein the output is configured such that the first and second drive intervals are sequential.

4. The device of claim 1, wherein the output is configured such that the first drive interval overlaps the second drive interval.

5. The device of claim 4, wherein the output is configured such that the second drive interval follows after the start of the first drive interval.

6. The device of claim 1, wherein the output is configured such that the first and second drive intervals are displacement intervals.

7. The device of claim 1, wherein the output is configured such that the first and second drive intervals have identical start and stop points and the second drive interval begins after the beginning of the first drive interval.

8. The device of claim 1, wherein the prime mover comprises a motor, and further comprising a controller configured to selectively operate the motor in forward and reverse directions.

9. A biopsy device, comprising:

a biopsy needle configured to have tissue-penetration and tissue-sampling modes;

a pump connected to the biopsy needle, the pump being configured to generate a vacuum in the biopsy needle;

a first drive element configured to operate the pump;

a second drive element configured to change the biopsy needle mode;

the first drive element being configured to have a first displacement interval and a second displacement interval, the first drive element being configured such that;

during the first displacement interval, the first drive element operates the pump to generate a vacuum in the biopsy needle; and

during the second displacement interval, the first drive element engages the second drive element to change the biopsy needle from the insertion mode to the tissue-sampling mode.

10. The device of claim 9, wherein the first drive element is configured such that the second displacement interval follows the first displacement interval.

11. The device of claim 9, wherein the first drive element is configured such that the first displacement interval overlaps the second displacement interval.

12. The device of claim 11, wherein the first drive element is configured such that the second displacement interval follows after the start of the first displacement interval.

13. The device of claim 9, wherein the first drive element is configured such that the first and second displacement intervals have the same endpoints and the second displacement interval starts after the start of the first displacement interval.

14. The device of claim 9, further comprising a motor with an output connected to the first drive element and a controller configured to selectively operate the motor in forward and reverse directions.

15. The device of claim 9, further comprising a housing configured to enclose the pump, the first and second drive elements, and a portion of the biopsy needle.

16. A biopsy device, comprising:

a biopsy needle configured to have a sampling mode for creating a tissue sample and configured to have an insertion/removal mode for inserting or extracting the biopsy needle from living tissue;

a pump connected to the biopsy needle, the pump being configured to generate a vacuum;

a first drive element configured to drive the pump;

a second drive element configured to place the biopsy needle in a selected mode;

a primary drive member configured to be displaced through a continuous range that defines a first interval and a second interval;

the primary drive member being configured such that during the first interval, a motive force is transmitted to the first drive element to cause the pump to generate a vacuum and, the primary drive member being configured such that during the second interval, a motive force is transmitted to the second drive element to change the biopsy needle from the insertion/removal mode to the sampling mode.

17. The device of claim 16, wherein the primary drive member is configured such that, during the second interval, a motive force continues to be transmitted to the first drive element to cause the pump to continue generating a vacuum.

18. The device of claim 16, wherein the primary drive member is configured such that the continuous range has a third interval, following the second interval, during which the second drive element changes the biopsy needle mode from the sampling mode to the insertion/withdrawal mode.

19. The device of claim 16, wherein the first drive element is spaced apart from the second drive element and configured such that the primary drive member engages the first drive element during the first interval and configured such that the primary drive member engages the second drive element during the second interval.

20. A biopsy device, comprising:

a biopsy needle configured to have a cutting mode used to cut a tissue sample, and configured to have an insertion mode in which the biopsy needle is insertable into a host;

a pump connected to the biopsy needle to generate a vacuum therein;

a prime mover having a primary output element configured to be displaced through a first displacement interval and a second displacement interval;

a transmission mechanism connected to the primary output element;

the transmission mechanism having at least a first transmission output configured to operate the pump and at least a second transmission output configured to change the biopsy needle mode of the biopsy needle;

the prime mover and the transmission mechanism being configured to cause the pump to generate a vacuum during the first displacement interval of the primary output element, and the prime mover and the transmission mechanism being configured to change the biopsy needle from the insertion mode to the cutting mode during the second displacement interval of the primary output element.

21. The device of claim 20, wherein the transmission mechanism includes a first drive element and a second drive element spaced apart therefrom, the first and second drive elements being configured to drive the first and second transmission outputs, respectively,

the primary output element being configured to drive the first drive element during the first displacement interval and to move at least one of the first drive element and the primary output element toward the second drive element until the at least one of the first drive element and the primary output element engages and drives the second drive element and thereafter drives the second drive element during the second displacement interval.

22. A biopsy device, comprising:

a biopsy needle configured to have sampling and insertion modes;

a pump connected to the biopsy needle, the pump being configured to generate a vacuum therein;

a motor and a transmission mechanism, the transmission mechanism being configured to apply a motive force from the motor to the pump during a first interval upon activation of the motor, and, during a second interval, following the first interval, to transmit motive force from the motor to the biopsy needle to change the biopsy needle from the insertion mode to the sampling mode such that a vacuum is generated by the pump before the biopsy needle is placed in the sampling mode.

23. The device of claim 22, configured such that the motor operates continuously during the first and second intervals.

24. The device of claim 22, configured such that both the pump and the motor are operated continuously during the first and second intervals.

25. The device of claim 22, configured such that the pump is operated continuously during the first and second intervals.

26. The device of claim 22, wherein the sampling mode of the biopsy needle includes a continuous cycle that includes a cycle portion operative to receive a tissue sample within the biopsy needle and a cycle portion operative to cut the tissue sample from a host.

27. The device of claim 22, wherein:

the biopsy needle has fixed shaft that defines a longitudinal axis, and a rotatable shaft movably connected to the fixed shaft and configured to rotate around the longitudinal axis;

the rotatable shaft includes a cutting blade configured to cut tissue samples;

the biopsy needle being configured such that the sampling mode includes a continuous sampling cycle, during the second interval, in which a tissue sample is cut and received within the biopsy needle; and

the transmission mechanism is configured to urge the rotatable shaft progressively during the second interval to cut a tissue sample.

28. A biopsy device, comprising:

a biopsy needle configured to have a sample access mode and an insertion mode, the biopsy needle having a sample chamber;

a pump connected to the sample chamber, the pump being configured to generate a vacuum;

a transmission mechanism with a drive input, the transmission mechanism being configured to change the mode of the biopsy needle;

the transmission mechanism being configured such that upon displacing the drive input in a first direction, the transmission mechanism transmits motive force from the motor to the pump during a first interval and, upon further displacing the drive input over a second interval that follows the first interval, the transmission mechanism transmits motive force to the biopsy needle to change the biopsy needle from the insertion mode to the sample access mode such that a vacuum is generated in the sample chamber before the biopsy needle mode is changed to the sample access mode.

29. The device of claim 28, wherein upon activation of the motor in a second direction, the transmission mechanism being configured to transmit motive force from the motor to the pump during a third interval following the second interval, and simultaneously change the biopsy needle from the insertion mode to the sample access mode to generate pressure in the sample chamber to eject a sample therefrom.

30. The device of claim 28, configured such that the pump is operated during at least part of the second interval.

31. The device of claim 28, configured such that the pump is operated throughout the second interval.

32. The device of claim 28, further comprising a housing configured to enclose the pump, the transmission mechanism, and a portion of the biopsy needle.

33. A biopsy device, comprising:

an elongate inner cylindrical member and an elongate outer cylindrical member;

the outer cylindrical member being coaxially aligned with the inner cylindrical member and rotatable with respect to the inner cylindrical member;

the inner cylindrical member having a port;

the outer cylindrical member having a cover portion capable of being aligned with the port to cover the port for insertion of the biopsy needle; and

the outer cylindrical member further having a cutting edge, the cutting edge having a lengthwise orientation, the cutting edge being adjacent to the cover portion, the outer cylindrical member being configured such that, as the outer cylindrical member is rotated progressively about the inner cylindrical member through a specified interval, the cutting edge passes over the port and the cover portion covers the port.

34. The biopsy device of claim 33, wherein the cutting edge and port are configured such that as the outer cylindrical member rotates, a progressively greater fraction of the cutting edge passes over the port.

35. The biopsy device of claim 33, wherein the inner cylindrical member has a trocar affixed to a distal tip thereof.

36. The biopsy device of claim 33, wherein the cutting edge is configured such that as the outer cylindrical member rotates, a progressively greater fraction of the cutting edge passes over the port, the cutting edge having at least a portion that is angled relative to a direction perpendicular to the direction of advance of the cutting edge.

37. The biopsy device of claim 33, wherein the port has a longitudinal side surface with at least one barb aligned with a port edge of the port and configured to be opposite the cutting edge of the outer cylindrical member as the cutting edge advances toward the port edge prior to covering the port.

38. The biopsy device of claim 33, wherein the inner cylindrical member has a sharp edge partly defining the port, the sharp edge having a portion extending that extends toward the axis of the inner cylindrical member and configured to be opposite the cutting edge of the outer cylindrical member as the cutting edge advances toward the port edge prior to covering the port.

39. A biopsy device, comprising:

a housing;

a biopsy needle partially disposed in the housing, the biopsy needle having a first member that defines a sample chamber and a second member that defines a sample volume with the sample chamber;

a pump coupled to the biopsy needle, the pump being configured to generate a vacuum at the sample chamber;

a primary drive element positioned within the housing, the primary drive element having a first drive interval and a sequential second drive interval;

a first transmission configured to be driven by the primary drive element during the first drive interval to operate the pump;

a second transmission configured to be driven by the primary drive element during the second drive interval that positions the first and second members of the biopsy needle to define the sample volume.

40. A biopsy device, comprising:

a biopsy needle with a sample chamber having an access opening;

the biopsy needle having a cover member movable relative to the access opening to cover the access opening;

a pump, the pump being connected to the biopsy needle, the pump being configured to generate a vacuum in the sample chamber;

a drive element configured to simultaneously drive the pump and move the cover member relative to the access opening through a sampling cycle over which the pump generates the vacuum in the sample chamber and the cover member moves relative to the sample chamber through a delay interval in which the access opening remains covered by the cover member and through a sampling interval, following the delay interval, in which the access opening is uncovered.

41. The device of claim 40, wherein the cover member has a cutting edge configured to cut a sample free of a host after the access opening is uncovered.

42. A biopsy device, comprising:

a cannula with a sample recess that has a cover configured to be selectively positioned to cover and uncover the sample recess, thereby permitting the recess to be selectively exposed to, and isolated from, an external environment;

a vacuum pump connected to the sample recess, the vacuum pump being configured to create a vacuum in the sample recess;

a drive having a first transmission element configured to drive the pump and a second transmission element configured to move the sample recess cover to cover and uncover the sample recess;

the drive being configured such that, during an operational cycle of the drive, the first transmission element is initially displaced at least to begin generating a vacuum, and then, subsequently, the first transmission element engages and displaces the second transmission element to uncover the sample recess.

43. The device of claim 42, wherein the first transmission element is configured to drive the pump and progressively uncover the sample recess for at least a portion of the operation cycle.

44. A biopsy device, comprising:

a cannula with a sample recess that has a cover configured to be selectively positioned to cover and uncover the sample recess, thereby permitting the sample recess to be selectively exposed to, and isolated from, an external environment;

a vacuum pump connected to the sample recess;

a drive having an output element, a first transmission element configured such that, when displaced, drives the pump, and a second transmission element configured such that, when displaced, moves the sample recess cover between covered and uncovered positions;

the drive being configured such that during an operational cycle, the output element is initially in engagement with the first transmission element such that as the output element is displaced, the first transmission element is displaced at least to begin generating a vacuum, and then, subsequently, as the output element is further displaced, the output element moves toward and engages the second transmission element to uncover the sample recess.

45. The device of claim 44, configured such that the pump is driven and the sample recess is simultaneously progressively uncovered for at least a portion of the operation cycle.

46. A method of obtaining tissue sample comprising:

inserting a sampling probe having a first component and a second component into biological tissue mass; and

directing motive force from a single motor output member to operate a pump in a first manner to generate a vacuum proximate the first component and to operate the second component to extract a tissue sample.

47. The method of claim 46, wherein the directing comprises operating the pump in a second manner to generate a positive pressure to expel the tissue sample.

48. The method of claim 46, wherein the second component extracts a tissue sample by cutting the tissue from the tissue mass.

49. The method of claim 46, wherein the directing includes initially applying motive force by said output member to the pump and later, by moving the output member a specified distance, engaging the second component to cut the tissue sample.

50. A method of obtaining tissue sample comprising:

moving a drive member, which is in engagement with a vacuum pump, over a first displacement interval to create a vacuum in a tissue sample chamber of a biopsy device;

moving the drive member further until, at the end of the first displacement interval, the drive member engages with a cutter and causes the cutter to resect a tissue sample from a host.

51. The method of claim 50, further comprising receiving the tissue sample in the tissue sample chamber.

52. The method of claim 50, wherein moving the drive member beyond the first displacement interval causes the drive member to uncover the sample chamber.

53. A biopsy device, comprising:

an elongate inner cylindrical member and an elongate outer cylindrical member;

the outer cylindrical member being coaxially aligned with the inner cylindrical member and movable with respect to the inner cylindrical member along a common axis of the inner and outer cylindrical members;

the inner cylindrical member having a port;

the outer cylindrical member having a cover portion capable of being aligned with the port to cover the port for insertion of the biopsy needle; and

a drive mechanism configured to drive a first transmission member connected to a vacuum pump, and the first transmission member is configured to drive a second transmission member connected to the outer cylindrical member to displace the outer cylindrical member without rotating the outer cylindrical member;

the outer cylindrical member further having a cutting edge adjacent to the cover portion and configured such that, as the outer cylindrical member is displaced along the inner cylindrical member by the drive mechanism, the cutting edge passes over the port and covers the port.

54. The biopsy device of claim 53, wherein the vacuum pump is connected to the inner cylindrical member, the vacuum pump being configured to create a vacuum in communication with the port.

55. The biopsy device of claim 53, wherein the inner cylindrical member has a trocar affixed to a distal tip thereof.