CORE BIOPSY DEVICE

• US 20060030785A1
• Filed: 05/11/2005
• Published: 02/09/2006
• Est. Priority Date: 05/11/2004
• Status: Active Grant

• Current Assignee: RLS Interventional, Inc.
• Original Assignee: Inrad Inc.
• Inventors: Field, Steven E., Johnson, Michael, Ireland, Todd, Haeske, Steve, Mulder, Brian R., Vander Veen, Mark
• Granted Patent: US 8,088,081 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• 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 10/0233 Pointed or sharp biopsy instruments
• 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 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end

Abstract

A core biopsy device comprises an outer cutting cannula in telescoping register with an inner spoon cannula. The outer cutting cannula is provided at a distal end with an arcuate excising blade that is biased radially inwardly to extend beyond the longitudinal axis of the cannula. The inner spoon cannula terminates at a distal end in an arcuate wall to form a biopsy sample spoon for supporting a biopsy sample thereon. The outer cutting cannula can be rotated relative to the inner spoon cannula so that the excising blade can excise the biopsy sample from the surrounding tissue. After removal of the core biopsy device from the tissue, the outer cutting cannula can be retracted away from the inner spoon cannula to reveal the biopsy sample and enable the sample to be removed from the biopsy device in a relatively undisturbed condition.

Claims

1. A biopsy apparatus for the percutaneous removal of a specimen from a tissue mass, the biopsy apparatus comprising:

an outer cannula defining a lumen and a longitudinal axis, the outer cannula having a proximal end and a distal end, and an excising finger extending from the distal end;

an inner cannula received within the lumen, the inner cannula defining a longitudinal axis and having a proximal end and a distal end; and

an actuator operably coupled to at least one of the outer cannula and inner cannula for axially moving the outer cannula relative to the inner cannula from an inserting position to an excising position where the excising finger extends toward the longitudinal axis of the inner cannula, and rotating the outer cannula about the longitudinal axis of the outer cannula when the outer cannula is in the excising position.

2. The biopsy apparatus according to claim 1, wherein the excising finger is adapted for resilient flexure.

3. The biopsy apparatus according to claim 2, wherein the flexure of the excising finger is alternately between a first position generally parallel to the longitudinal axis of the inner cannula and a second position toward the longitudinal axis of the inner cannula.

4. The biopsy apparatus according to claim 3, wherein the excising finger rides along the inner cannula during at least a portion of the axial movement to the excising position.

5. The biopsy apparatus according to claim 4, wherein the excising finger is in the first position as it rides along the inner cannula.

6. The biopsy apparatus according to claim 5, wherein the excising finger flexes from the first position toward the second position as the excising finger axially slides past the distal end of the inner cannula.

7. The biopsy apparatus according to claim 1, wherein the shape of the excising finger is at least one of arcuate, rectilinear, and trapezoidal.

8. The biopsy apparatus according to claim 1, wherein the excising finger extends longitudinally from the distal end of the outer cannula.

9. The biopsy apparatus according to claim 8, wherein the excising finger extends at least to the longitudinal axis of the outer cannula.

10. The biopsy apparatus according to claim 1, wherein the actuator axially advances the outer cannula and the inner cannula when moving the outer cannula to the excising position.

11. The biopsy apparatus according to claim 10, wherein the actuator stops the axial advancement of the inner cannula prior to the outer cannula reaching the excising position.

12. The biopsy apparatus according to claim 1, wherein the inner cannula comprises a spoon portion that terminates at the distal end for supporting a biopsy sample.

13. The biopsy apparatus according to claim 12, wherein the spoon portion comprises an arcuate cross section.

14. The biopsy apparatus according to claim 13, wherein the arcuate cross section spans an arc of 180 degrees or less.

15. The biopsy apparatus according to claim 13, wherein the arcuate cross section spans an arc of greater than 180 degrees.

16. The biopsy apparatus according to claim 13, wherein the spoon portion terminates in a sharpened edge.

17. The biopsy apparatus according to claim 1, wherein the inner cannula has a lateral opening near the distal end and the excising finger extends through the lateral opening in the excising position.

18. The biopsy apparatus according to claim 1, and further comprising a stylet received within the inner cannula to substantially close off the inner cannula in the inserting position.

19. The biopsy apparatus according to claim 18, wherein the actuator axially advances the outer cannula relative to the stylet when moving the outer cannula to the excising position to form a tissue receiving area between the distal end of the outer cannula and the stylet.

20. The biopsy apparatus according to claim 19, wherein the position of the stylet is adjustable relative to the excising position of the outer cannula to provide for adjusting the length of the tissue receiving area.

21. The biopsy apparatus according to claim 1, wherein the actuator, inner cannula, and outer cannula collectively define an integrated self-contained hand-holdable device that can be easily and conveniently handled by a user to effect operation of the biopsy apparatus.

22. The biopsy apparatus according to claim 1, wherein the actuator rotates the outer cannula at least a partial revolution.

23. The biopsy apparatus according to claim 22, wherein the actuator rotates the outer cannula for at least one revolution.

24. The biopsy apparatus according to claim 23, wherein the outer cannula is rotated at least 1½

revolution.

25. The biopsy apparatus according to claim 1 wherein the actuator comprises a hollow interior and a carriage slidably mounted within the hollow interior and carrying the outer cannula whereby the slidable movement of the carriage moves the outer cannula to the excising position.

26. The biopsy apparatus according to claim 25 wherein the actuator further comprises a driver operably coupled to the carriage to rotate the outer carriage and thereby effect the rotation of the outer cannula.

27. The biopsy apparatus according to claim 26 wherein the actuator further comprises a clutch operably coupling the driver to the carriage when the outer cannula is to the excising position.

28. The biopsy apparatus according to claim 27 wherein the carriage comprises a gear, the driver comprises a helical slot, and the clutch comprises a driven member keyed to the helical slot and having a gear that meshes with the gear of the carriage when the outer cannula is in the excising position such that the axial movement of the driven member rotates the driven member to effect the rotation of the carriage.

29. The biopsy apparatus according to claim 28 wherein the actuator comprises a first biasing device for sliding the carriage to move the outer cannula to the excising position.

30. The biopsy apparatus according to claim 29 wherein the actuator further comprises a second biasing device for axially moving the driver relative to the driven member.

31. The biopsy apparatus according to claim 1 and further comprising a dual trigger to trigger movement of the outer cannula, wherein the dual trigger comprises a first trigger located at a first portion of the actuator and a second trigger located at a second portion of the actuator.

32. The biopsy apparatus according to claim 31 wherein the first portion is near the front of the actuator and the second portion is near the rear of the actuator.

33. The biopsy apparatus according to claim 31 wherein the actuator can be triggered by actuating either one of the first trigger and the second trigger.

34. The biopsy apparatus according to claim 1 wherein the actuator further comprises a lever pivotally movable between a first, open position and a second, closed position and the lever is spring-biased to the first position, and a latch movable between a first latch position to prevent the lever from moving from the second position to the first position and a second latch position to permit the lever to move from the second position to the first position.

35. The biopsy apparatus according to claim 34 wherein the latch is configured such that the latch moves to the second position when the lever has twice moved to the closed position.

36. The biopsy apparatus according to claim 34 wherein the latch is configured such that, after movement to the first position, the latch moves to the second position when the lever has twice moved to the closed position.

37. A biopsy apparatus for the percutaneous removal of a specimen from a tissue mass, the biopsy apparatus comprising:

an outer cannula defining a lumen and a longitudinal axis, the outer cannula having a proximal end and a distal end; and

an inner cannula received within the lumen of the outer cannula and having a proximal end and a distal end, the inner cannula having a spoon portion that terminates at the distal end;

whereby upon the performance of a biopsy, the specimen is received within the lumen and supported on the spoon portion, and relatively moving the cannulae exposes the specimen supported on the spoon portion to permit the removal of the specimen from the spoon portion.

38. The biopsy apparatus according to claim 37, and further comprising an excising finger extending from the distal end of the outer cannula.

39. The biopsy apparatus according to claim 38, wherein the excising finger is adapted for resilient flexure.

40. The biopsy apparatus according to claim 39, wherein the flexure of the excising finger is alternately between a first position generally parallel to the longitudinal axis of the inner cannula and a second position toward the longitudinal axis of the inner cannula.

41. The biopsy apparatus according to claim 40, wherein the excising finger is of a sufficient length that it extends at least to the longitudinal axis when in the second position.

42. The biopsy apparatus according to claim 37, and further comprising an actuator operably coupled to the inner and outer cannulae for axially moving the outer cannula relative to the inner cannula from an inserting position to an excising position where the excising finger extends towards a longitudinal axis of the inner cannula and a sample is received within the outer cannula, and then rotating the outer cannula about the longitudinal axis of the outer cannula when the outer cannula is in the excising position to sever the sample from the tissue mass.

43. The biopsy apparatus according to claim 42, wherein the actuator simultaneously moves the outer cannula and the inner cannula.

44. The biopsy apparatus according to claim 42, wherein the actuator sequentially moves the outer cannula and the inner cannula.

45. The biopsy apparatus according to claim 42, wherein the actuator, inner cannula, and outer cannula collectively define an integrated self-contained hand-holdable device that can be easily and conveniently handled by a user to effect operation of the biopsy apparatus.

46. The biopsy apparatus according to claim 42, wherein the actuator rotates the outer cannula at least a partial revolution.

47. The biopsy apparatus according to claim 46, wherein the actuator rotates the outer cannula for at least one revolution.

48. The biopsy apparatus according to claim 47, wherein the outer cannula is rotated at least 1½

revolution.

49. The biopsy apparatus according to claim 37, wherein the spoon portion comprises an arcuate cross section.

50. The biopsy apparatus according to claim 49, wherein the arcuate cross sections spans an arc of 180 degrees or less.

51. The biopsy apparatus according to claim 49, wherein the arcuate cross section spans an arc of greater than 180 degrees.

52. The biopsy apparatus according to claim 49, wherein the spoon portion terminates in a sharpened edge.

53. The biopsy apparatus according to claim 38, wherein the inner cannula has an opening at the distal end and the excising finger extends through the opening.

54. The biopsy apparatus according to claim 37, and further comprising a stylet received within the inner cannula to substantially close off the inner cannula prior to the taking of the sample.

55. The biopsy apparatus according to claim 37, wherein the outer cannula comprises a spoon portion that terminates at the distal end for supporting a biopsy sample.

56. A method of conducting a percutaneous biopsy by removing a core specimen from a predetermined site in a tissue mass, the method comprising:

advancing an open-tipped cannula into the predetermined site in the tissue mass to at least partially form a specimen core containing at least a portion of the tissue at the predetermined site, with the core having a proximal portion contained within the open-tipped cannula and a distal portion attached to the tissue mass;

automatically extending an excising finger into the distal portion; and

automatically rotating the excising finger to sever the distal portion of the core specimen from the surrounding tissue.

57. The method according to claim 56, wherein the steps of advancing the open-tipped cannula and automatically extending the excising finger are done simultaneously.

58. The method according to claim 57, wherein the step of rotating the excising finger is done after the completing of the extending of the excising finger.

59. The method according to claim 56, and further comprising supporting the core specimen independent of the cannula.

60. The method according to claim 59, wherein the supporting step further comprises inserting a spoon-shaped specimen support into the cannula with the spoon-shaped specimen supporting at least a portion of the core specimen.

61. The method according to claim 60, wherein the inserting of the spoon-shaped specimen support is conducted prior to the advancement of the cannula.

62. The method according to claim 61, wherein the spoon-shaped support is advanced along with the cannula.

63. The method according to claim 62, wherein the excising finger is extended beyond the spoon-shaped support into the tissue mass.

64. The method according to claim 59, and further comprising retracting the cannula to expose the independently supported specimen.

65. The method according to claim 64, and further comprising withdrawing the cannula from the tissue mass prior to retracting the cannula.

66. The method according to claim 56, wherein the automatic rotation of the excising finger comprises rotating the excising finger at least a partial revolution.

67. The method according to claim 66, and further comprising rotating the cannula at least one revolution.

68. The method according to claim 67, and further comprising rotating the cannula at least 1½

revolution.

69. The method according to claim 66, wherein the automatic extension of the excising finger comprises extending the excising finger to at least a centerline of the cannula.

70. The method according to claim 66, and further comprising rotating the excising finger during advancement of the open-tipped cannula.

71. The method according to claim 62, and further comprising retracting the open-tipped cannula while rotating the excising finger.

72. A method of conducting a percutaneous biopsy by removing a core specimen from a predetermined site in a tissue mass, the method comprising:

advancing an open-tipped cannula defining a lumen into the predetermined site in the tissue mass to at least partially form a specimen core containing at least a portion of the tissue at the predetermined site;

advancing an inner cannula terminating in a spoon portion within the lumen of the outer cannula such that the specimen core is supported by the spoon portion;

severing the specimen core from the tissue mass;

withdrawing the open-tipped cannula and inner cannula from the tissue mass; and

relatively moving the cannulae to expose the specimen core supported on the spoon portion to permit the removal of the specimen core therefrom.

73. The method according to claim 72, wherein the inserting of the spoon-shaped specimen support is conducted prior to the advancement of the open-tipped cannula.

74. The method according to claim 72, wherein the spoon-shaped support is advanced along with the open-tipped cannula.

75. The method according to claim 72, and further comprising retracting the open-tipped cannula to expose at least part of the spoon portion.

76. The method according to claim 72, wherein the severing of the specimen core is at least partially accomplished by advancing of the open-tipped cannula.

77. The method according to claim 76, wherein the severing of the specimen core further comprises rotating one of the open-tipped cannula and the inner cannula.

78. The method according to claim 77, wherein the at least one of the open-tipped cannula and the inner cannula is rotated at least a partial revolution.

79. The method according to claim 78, wherein the at least one of the open-tipped cannula and the inner cannula is rotated at least one revolution.

80. The method according to claim 78, wherein the at least one of the open-tipped cannula and the inner cannula comprises an excising finger for severing the specimen core upon rotation.

81. The method according to claim 72, and further comprising advancing a stylet through the inner cannula to expel the specimen from the spoon portion.