Self-contained Handheld Biopsy Needle

• US 20100234760A1
• Filed: 08/17/2007
• Published: 09/16/2010
• 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
• Granted Patent: US 8,251,917 B2
• Time in Patent Office: Days
• 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 projecting 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 that generates a vacuum in the sample volume;

a primary drive element having a first drive interval and a second drive interval;

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

a second transmission, 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.

2. The device of claim 1, further comprising a housing enclosing the pump, the primary drive element, the first transmission, the second transmission, and a portion of the biopsy needle.

3. The device of claim 1, wherein the first and second drive intervals are sequential.

4. The device of claim 1, wherein the first drive interval overlaps the second drive interval.

5. The device of claim 4, wherein the second drive interval follows after the start of the first drive interval.

6. The device of claim 1, wherein the first and second drive intervals are displacement intervals.

7. The device of claim 1, wherein 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, further comprising a motor with an output connected to the primary drive element and a controller that selectively operates the motor in forward and reverse directions.

9. A biopsy device, comprising:

a biopsy needle having tissue-penetration and tissue-sampling modes;

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

a first drive element connected to operate the pump;

a second drive element to change the biopsy needle mode;

the first drive element having a first displacement interval and a second displacement interval 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 second displacement interval follows the first displacement interval.

11. The device of claim 9, wherein the first displacement interval overlaps the second displacement interval.

12. The device of claim 11, wherein the second displacement interval follows after the start of the first displacement interval.

13. The device of claim 9, wherein 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 that selectively operates the motor in forward and reverse directions.

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

16. A biopsy device, comprising:

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

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

a first drive element connected to drive the pump;

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

a primary drive member that is displaced through a continuous range having a first interval and a second interval;

during the first interval, a motive force being transmitted through the primary drive member to the first drive element to cause the pump to generate a vacuum and, during the second interval, a motive force being 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, 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 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 such that the primary drive member engages the first drive element during the first interval and, as it moves toward the second drive element, engages the second drive element during the second interval.

20. A biopsy device, comprising:

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

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

a prime mover, with a primary output element, which can be displaced through first and second displacement intervals;

a transmission mechanism connected to the primary output element;

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

the transmission mechanism cause the pump to generate a vacuum during a first displacement of the primary output element and to change the biopsy needle from the insertion mode to the cutting mode during a second displacement 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 driving the first and second transmission outputs, respectively, the primary output element being arranged to drive the first drive element during the first displacement and to move at least one of the first drive element and the primary output element toward the second drive element until it engages and drives the second drive element and thereafter drives the second drive element during the second displacement.

22. A biopsy device, comprising:

a biopsy needle that has sampling and insertion modes;

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

a motor and a transmission mechanism, the transmission mechanism applying 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 it from the insertion mode to the sampling mode such that a substantial vacuum is generated by the pump before the biopsy needle is placed in the sampling mode.

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

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

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

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

27. The device of claim 22, wherein:

the biopsy needle has fixed shaft defining a longitudinal axis, and a rotating shaft movably connected to the fixed shaft to rotate around the longitudinal axis;

the rotating shaft includes a cutting blade to cut tissue samples;

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;

the transmission mechanism urging the rotating shaft progressively during the second interval to cut a tissue sample and cause it to be received in the biopsy needle.

28. A biopsy device, comprising:

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

a pump connected to the sample chamber to generate a vacuum therein;

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

upon displacing the drive input in a first direction, the transmission mechanism transmitting 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 transmitting motive force to the biopsy needle to change it from the insertion mode to the sample access mode such that a substantial 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 transmits a motive force from the motor to the pump during a third interval following the second interval, and simultaneously changes 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, wherein the pump is operated during at least part of the second interval.

31. The device of claim 28, wherein the pump is operated throughout the second interval.

32. The device of claim 28, further comprising a housing enclosing 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 it;

the inner cylindrical member having a port;

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

the outer cylindrical member further having a cutting edge adjacent to the cover portion 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 covers the port.

34. The biopsy device of claim 33, wherein cutting edge and port are shaped 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 cutting edge is shaped 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 the perpendicular to the direction of advance of the cutting edge.

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

39. A biopsy device, comprising:

a housing that defines a chamber;

a biopsy needle partially disposed in the chamber, 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 that generates a vacuum at the sample chamber;

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

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

a second transmission 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 to generate a vacuum in the sample chamber;

a drive element simultaneously driving the pump and moving the cover member relative to the access opening through a sampling cycle over which the pump generates a 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 which cuts 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 that can 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 to create a vacuum therein;

a drive having a first transmission element which, when displaced, drives the pump and a second transmission element which, when displaced, moves the sample recess cover to cover and uncover the sample recess;

the drive being in engagement with the first transmission element 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 drives the pump and progressively uncovers 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 that can be selectively positioned to cover and uncover, thereby permitting the recess to be selectively exposed to, and isolated from, an external environment;

a vacuum pump connected to the sample recess to create a vacuum therein;

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

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

45. The device of claim 44, wherein 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 generate a vacuum proximate the first component and extract a tissue sample by the second component.

47. The method of claim 46, wherein the directing comprises generating 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 a vacuum 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, it 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 it 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 it 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 it for insertion of the biopsy needle; and

a drive mechanism that drives a first transmission member connected to a vacuum pump, which first transmission member drives a second transmission member connected to the outer cylindrical member to displace it without rotating it;

the outer cylindrical member further having a cutting edge adjacent to the cover portion 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 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.