Brachytherapy instrument and methods

• US 6,752,753 B1
• Filed: 04/12/2002
• Issued: 06/22/2004
• Est. Priority Date: 10/15/1999
• Status: Expired due to Fees

• Current Assignee: F.A. Voight & Associates, L.P.
• Original Assignee: Deschutes Medical Products, Inc.
• Inventors: Hoskins, Matthew W., Chang, Linyee, Kong, Huiwen, Hammerman, Melissa Buan
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/110,562
• Time in Patent Office: 802 Days
• Field of Search: 600/1-8
• US Class Current: 600/7
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 2005/1012 Templates or grids for guiding the introduction of sources
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

A brachytherapy instrument and method is disclosed for delivering therapeutic substances such as radioactive seeds, to internal organs, such as the prostate. The instrument includes a needle (602) and stylet (604) which are capable of reciprocating relative to one another, but which can be selectively fixed against such movement. The needle (602) is loaded with radioactive seeds, and the stylet (604) advances the seeds to the distal end of the needle.

Claims

1. A brachytherapy device, comprising:

an elongated needle having a sharp end for insertion into target tissue;

an elongated stylet which can slide through the needle; and

a housing that selectively engages the needle and stylet to selectively fix the needle and stylet against axial movement, while allowing the needle to selectively move axially relative to the stylet when the stylet is fixed against axial movement, and allowing the stylet to selectively move axially relative to the needle when the needle is fixed against axial movement.

2. The device of claim 1, wherein the needle comprises a closed shank and the sharp end is open.

3. The device of claim 1, wherein the housing independently selectively engages the needle and stylet.

4. The device of claim 1, wherein the housing disengages the needle while simultaneously engaging the stylet.

5. The device of claim 1, wherein the housing selectively engages and disengages the needle in response to relative rotation between the needle and the housing.

6. The device of claim 1, wherein the housing selectively engages and disengages the stylet in response to relative rotation between the stylet and the housing or between the needle and the housing.

7. The device of claim 1, wherein relative rotation between the needle and the housing selectively disengages the needle from the housing, and the relative rotation that disengages the needle also engages the stylet to the housing.

8. The device of claim 1, wherein the housing, the needle and the stylet have cooperating members that interact to selectively fix the needle and stylet against axial movement.

9. The device of claim 7, wherein the cooperating members comprise a groove and a projection which slides into the groove.

10. The device of claim 9, wherein the groove comprises a separate needle groove and a stylet groove, and the stylet groove is angled to advance the stylet in response to relative rotation between the stylet and the housing.

11. The device of claim 10, wherein the needle groove is contained in a plane perpendicular to a direction of axial movement of the needle in the housing.

12. The device of claim 10, wherein the stylet groove comprises a plurality of substantially parallel, non-communicating grooves.

13. The device of claim 9, wherein the projection comprises a projection from the needle that rotates into engagement with the groove to selectively fix the needle against axial movement relative to the housing.

14. The device of claim 13, wherein the groove comprises a thread in a wall of the housing.

15. The device of claim 13, wherein the groove comprises a gap in a collar that limits axial movement of the needle relative to the housing except when the projection from the needle aligns with the gap.

16. The device of claim 8, wherein the cooperating members comprise triggers on each of the stylet and needle which are independently actuated to move the stylet or needle relative to the housing.

17. The device of claim 16, wherein the triggers comprise deformable members on each of the stylet and needle, wherein the deformable members in a first position engage the housing, but wherein each of the deformable members are selectively deformable out of engagement with the housing to move the deformable member and the stylet or needle to which the deformable member is attached.

18. The device of claim 1, further comprising a spacer extending from a distal end of the instrument.

19. The device of claim 18, wherein a length of the spacer may be selectively altered.

20. The device of claim 1, further comprising a stop member comprising a stop portion that opposes advancement of the needle along the path of insertion beyond a preselected distance.

21. The device of claim 20, wherein the stop portion comprises an aperture or notch of a size that permits the needle to pass through it, but which abuts against an enlarged diameter portion of the device to oppose advancement of the needle beyond the preselected distance.

22. The device of claim 21, wherein the needle further comprises a first mating member, and the aperture or notch comprises a second mating member, wherein the first and second mating members cooperate to resist rotation and withdrawal of the needle.

23. The device of claim 22, wherein the first and second mating members are engaged by rotating the needle.

24. The device of claim 21, wherein the stop member comprises a plate.

25. The device of claim 24, wherein the plate includes a series of slots with notches at pre-selected positions in which the needle can seat.

26. The device of claim 20, wherein the stop member comprises a movable member that is selectively alignable with the path of insertion of the needle.

27. The device of claim 26, wherein the stop member is pivotable into and away from the path of insertion of the needle.

28. The device of claim 27, wherein the stop member is a pivotable arm comprising a plurality of notches that are selectively alignable with a template position.

29. The device of claim 28, wherein the pivotable arm pivots in a plane substantially perpendicular to the path of insertion.

30. The device of claim 20, wherein the stop member further includes an ultrasound transducer attachment bracket.

31. The device of claim 20, wherein the stop member comprises a proximal stop member and distal stop member that are movable apart from one another along the path of insertion of the needle to a limit distance, and the proximal and distal stop members define aligned apertures or notches through which the needle may be inserted, and the apertures or notches of the distal stop member are smaller than the apertures of the proximal stop member, so that advancement of the needle along the path of insertion moves the distal stop member away from the proximal stop member, but the apertures or notches of the distal stop member are deformable to allow the needle to be inserted therethrough by the application of sufficient insertion force after the distal stop member reaches the limit distance.

60. The instrument of claim 1, wherein the housing is generally tubular and has an axial slot formed therein extending from a proximal end to a point spaced from the distal end, the slot having a first side edge formed with a first repeating pattern of projection and a second side edge formed with a second pattern of projections,

wherein the needle extension portion is a knob having a hub portion slidable within the housing, and the stylet hub is a knob having a hub portion slidable within the housing, the knobs extending through the slot and being depressible in a radial direction, the needle knob having an engagement portion for engaging the first repeating pattern and the stylet knob having a engagement portion for engaging the second repeating pattern, and

wherein each of the needle and the stylet is selectively engageable with the respective side of the slot to prevent axial movement relative to housing.

80. The needle stop of claim 25, wherein the arm includes a locking rib engageable with a corresponding groove formed in the needle to stabilize the needle.

32. A brachytherapy device, comprising:

an elongated needle having a sharp end for insertion into target tissue;

an elongated stylet which can slide through the needle; and

a housing that selectively engages the needle and stylet to selectively fix the needle and stylet against axial movement, wherein relative rotation between the housing and needle selectively engages the needle to the housing to fix the needle against axial movement relative to the housing, and relative rotation between the housing and the stylet selectively engages the stylet to the housing to fix the stylet against axial movement relative to the housing.

33. The device of claim 32, wherein relative rotation between the housing and the needle selectively disengages the needle from the housing to permit axial movement of the needle relative to the housing, and relative rotation between the housing and the stylet selectively disengages the stylet from the housing to permit axial movement of the stylet relative to the housing.

34. The device of claim 33, wherein the same relative rotation between the housing and the needle that selectively engages the needle to the housing also disengages the stylet from the housing.

35. The device of claim 34, wherein the housing, the needle and the stylet have cooperating members that interact to selectively fix the needle and stylet against axial movement.

36. The device of claim 35, wherein the cooperating members comprise a groove and a projection which slides into the groove.

37. The device of claim 36, wherein the groove comprises a separate needle groove and a stylet groove, and the stylet groove is angled to advance the stylet in response to relative rotation between the stylet and the housing.

38. The device of claim 37, wherein the needle groove is contained in a plane perpendicular to a direction of axial movement of the needle in the housing.

39. The device of claim 37, wherein the stylet groove comprises a plurality of substantially parallel, non-communicating grooves.

40. The device of claim 36, wherein the projection comprises a projection from the needle that rotates into engagement with the groove to selectively fix the needle against axial movement relative to the housing.

41. The device of claim 40, wherein the groove comprises a thread in a wall of the housing.

42. The device of claim 40, wherein the groove comprises a gap in a collar that limits axial movement of the needle relative to the housing except when the projection from the needle aligns with the gap.

43. A brachytherapy device, comprising:

an elongated needle having a sharp end for insertion into target tissue;

an elongated stylet which can slide through the needle; and

a housing that selectively engages the needle to selectively fix the needle against axial movement, wherein rotation of the needle relative to the housing selectively engages the needle to the housing to fix the needle against axial movement relative to the housing, whereby rotation of the needle also reduces frictional engagement between the needle and the target tissue.

44. The device of claim 43, wherein the housing and the needle have cooperating members that interact to selectively fix the needle and stylet against axial movement.

45. The device of claim 44, wherein the cooperating members comprise a needle groove and a projection which slides into the groove.

46. The device of claim 45, wherein the needle groove is contained in a plane perpendicular to a direction of axial movement of the needle in the housing.

47. The device of claim 46, wherein the projection comprises a projection from the needle that rotates into engagement with the needle groove to selectively fix the needle against axial movement relative to the housing, and the groove comprises a thread in a wall of the housing.

48. The device of claim 45, wherein the groove comprises a gap in a collar that limits axial movement of the needle relative to the housing except when the projection from the needle aligns with the gap.

49. An instrument for use in implanting seeds within a patient'"'"'s body, comprising:

a hollow needle coincident with a central axis of the instrument, the needle having a needle tip that defines a distal end of the instrument, a needle shaft extending from the needle tip and a needle extension portion attached to a proximal end of the needle shaft;

a stylet insertible into the needle shaft from the proximal end of the needle, the stylet having a distal end, a stylet shaft extending from the distal end and a stylet hub attached to a proximal end of the stylet;

a housing that extends at least partially around the central axis and has a distal end through which the needle shaft extends, the housing being shaped to receive and engage the needle extension portion and the stylet hub to coordinate axial movement of the needle and stylet relative to each other and the housing.

50. The instrument of claim 49, wherein the housing is channel-shaped and has a generally arcuate cross-section, and an inner surface of the housing is formed with a series of spaced threads.

51. The instrument of claim 49, wherein the housing is generally tubular with an axial slot formed therein.

52. The instrument of claim 51, wherein the housing is hinged in the axial direction such that it can be opened to receive the needle and stylet and closed for operation.

53. The instrument of claim 49, wherein the distal end of the housing has an opening sized larger than the needle shaft and smaller than a cross-section of the needle extension portion, thereby allowing axial movement of the needle relative to the housing over a predetermined distance but preventing the needle extension portion from advancing beyond the distal end of the housing.

54. The instrument of claim 49, wherein a proximal end of the housing has an opening sized larger than the needle extension portion such that the needle can be inserted into and retracted from the proximal end of the housing in the axial direction.

55. The instrument of claim 49, wherein the housing is channel-shaped and has a generally arcuate cross-section, and an inner surface of the housing is formed with a series of spaced, interrupted threads extending from a proximal end of the housing towards the distal end, the housing having respective collars formed at the distal and proximal ends,

wherein the distal collar defines a first opening transverse to the central axis and sized larger than the needle shaft and smaller than the needle extension portion, the first collar thereby preventing the needle extension portion from being advanced in the axial direction beyond the distal end of the housing, and

wherein the proximal collar defines a second opening transverse to the central axis and sized larger than the needle extension portion thereby allowing the needle to be retracted in the axial direction and removed from the housing.

56. The instrument of claim 55, wherein the first and second openings communicate with respective first and second gaps in the distal and proximal collars, the first and second gaps being defined between respective terminal ends of the distal and proximal collar members and a common side of the housing, and wherein the first and second gaps are aligned in an axial direction.

57. The instrument of claim 49, wherein the housing includes a needle receiving feature and the needle includes a needle engaging feature engageable with the needle receiving feature, wherein when the needle is engaged with the housing, the needle cannot be moved in the axial direction relative to the housing.

58. The instrument of claim 57, wherein the needle receiving feature is a groove formed in an inner surface of the housing and extending in a direction transverse to the axial direction, and wherein the needle engaging feature is a projection from an outer surface of the needle extension portion, the projection being engageable with the groove when the needle is rotated relative to the housing.

59. The instrument of claim 49, wherein the needle extension portion is rotatably engageable with the housing such that over a first part of a rotation between the needle extension portion and the housing prevents axial movement of the needle and over a second portion of the rotation the needle extension portion can be retracted in the axial direction relative to the housing.

61. The instrument of claim 49, wherein the needle extension portion includes an axial groove formed therein parallel to the central axis and aligned with the needle shaft, the groove being sized to receive seeds to be loaded into the needle shaft and the stylet shaft.

62. The instrument of claim 49, further comprising a pusher used to cover seeds in the needle extension portion prior to loading and to load seeds into the needle shaft, wherein the needle extension portion is formed with an axial slot extending from a proximal end of the needle extension portion to the proximal end of the needle shaft, the axial slot being sized to receive the pusher and having a groove sized to receive seeds formed in a base thereof.

63. The instrument of claim 49, wherein the needle extension portion is formed with an axial slot extending from a proximal end of the needle extension portion to the proximal end of the needle shaft, the axial slot having a groove sized to receive seeds formed in a base thereof, and wherein the stylet hub is shaped to slide within the slot with the stylet shaft in the groove.

65. The instrument of claim 49, further comprising a spacer attached to a distal end of the housing.

66. The instrument of claim 65, wherein the spacer is resilient such that with the spacer in contact with a stationary object, the spacer flexes to permit the housing to be advanced slightly in the axial direction under a force and returned to a normal position when the force is relaxed.

67. The instrument of claim 66, wherein the spacer is an arm selectively engageable with the body to position a distal end of the arm at a predetermined axial distance from the distal end of the housing.

68. The instrument of claim 67, wherein the arm is selectively slidable along a side of the housing.

69. The instrument of claim 65, wherein the spacer is a pair of resilient wings attached to the distal end of the housing on opposite sides of the needle shaft.

70. The instrument of claim 49, wherein the housing is channel-shaped and has a generally arcuate cross-section, the housing having first and second collars respectively formed at distal and proximal ends thereof,

wherein the first collar defines a first opening transverse to the central axis and sized larger than the needle shaft and smaller than the needle extension portion, the first collar thereby preventing the needle extension portion from being advanced in the axial direction beyond the distal end of the housing,

wherein the second collar defines a second opening transverse to the central axis and sized larger than the needle extension portion, the second opening communicating with a gap defined between a terminal end of the collar and a side of the housing, and

wherein the needle extension portion is rotatable within the housing and has a generally cylindrical outer surface with an axial rib formed thereon, the rib preventing the needle from being retracted relative to the housing unless the rib is aligned with the gap in the second collar.

71. The instrument of claim 49 wherein the distal end of the housing includes a flat portion designed to contact a stationary object to maintain the instrument at a predetermined axial position with the needle tip inserted in the body to a predetermined insertion depth.

72. The instrument of claim 71, wherein the housing includes a step formed in its outer surface spaced proximally from the flat portion, and wherein the step can be brought into contact with the stationary object to maintain the instrument at a predetermined axial position with the needle inserted in the body to an over-insertion depth.

73. The instrument of claim 71, wherein the housing includes a groove formed in its outer surface spaced proximally from the flat portion, the stationary object includes a rib sized to fit within the groove, and the groove can be engaged with the rib on the stationary object to maintain the instrument at a predetermined axial position with the needle inserted in the body to an over-insertion depth.

74. The instrument of claim 49, wherein the stylet hub is includes a coupling that selectively couples with the needle extension portion when the stylet hub is moved within a predetermined distance of the needle extension portion.

75. The instrument of claim 74, wherein the coupling includes a hook extending in a distal direction from the stylet hub, and the needle extension portion has a hook receiver positioned near its distal end, and wherein when the stylet is advanced in the axial direction toward the distal end of the needle extension portion, the hook on the stylet hub engages the hook receiver on the needle extension portion.

64. The instrument of 63, wherein the housing is channel-shaped and has a generally arcuate cross-section, and an inner surface of the housing is formed with a series of spaced, interrupted threads extending from a proximal end of the housing towards the distal end, the housing having respective first and second collars formed at the distal and proximal ends,

wherein the first collar defines a first opening transverse to the central axis and sized larger than the needle shaft and smaller than the needle extension portion, the first collar thereby preventing the needle extension portion from being advanced in the axial direction beyond the distal end of the housing,

wherein the second collar defines a second opening transverse to the central axis and sized larger than the needle extension portion thereby allowing the needle to be retracted in the axial direction and removed from the housing, and

wherein the stylet hub has a projection extending in a radial direction relative to the central axis and rotatable into engageable with one of the threads of the housing such that further rotation causes the stylet to advance in the axial direction relative to the needle and the housing.

76. A needle stop for use in a brachytherapy procedure to prevent a needle extending in an axial direction from advancing beyond a predetermined position, the needle stop comprising a body extending transverse to the axial direction and having:

a needle receiving side with a plurality of slots formed therein in a direction perpendicular to the axial direction, each of the slots being sized to allow a shaft of a needle to pass therethrough as the needle is inserted;

a needle stop surface on the needle receiving side that stops insertion of the needle through contact by an enlarged portion of the needle with the stop surface; and

an attachment portion that allows the needle stop to be attached to an object.

77. A needle guide through which a brachytherapy needle having a needle tip can be inserted, the needle guide comprising:

a stationary first member having a first plurality of apertures extending in an axial direction and sized to allow the needle shaft to pass therethrough; and

a second member that is coupled to the first member for movement in a direction of needle insertion, the second member having a second plurality of apertures corresponding to the first plurality of apertures, the second plurality of apertures being dimensioned smaller than the needle shaft;

whereby the second member receives a tip of a needle inserted through the first member from the insertion side and into one of the second plurality of apertures, the second member moving with and guiding the tip as the needle advances in the axial direction.

78. A needle stop for use in a brachytherapy procedure with a needle being inserted in an insertion direction, the needle having a needle tip, a needle shaft extending from the needle tip and a needle extension portion having a cross-section greater than a cross-section of the needle shaft, the needle stop comprising:

a stationary base; and

a movable stop arm pivotably attached to the based and positionable transverse to the insertion direction at a predetermined location, the stop arm having an edge against which the needle extension portion is brought in contact to prevent the needle from being advanced in the insertion direction.

79. The needle stop of claim 78, wherein the arm includes at least one groove through which the needle shaft passes as the needle is advanced in the insertion direction.

81. A method of implanting brachytherapy seeds, the method comprising:

providing an elongated needle having a sharp end for insertion into target tissue, an elongated stylet which can slide through the needle, and a housing that selectively engages the needle to selectively fix the needle against axial movement by rotating the needle;

rotating the needle to engage the needle with the housing;

inserting brachytherapy seeds into the needle;

inserting the stylet into the needle to advance the seeds toward a sharp end of the needle;

inserting the needle into the target tissue;

rotating the needle to disengage the needle from the housing and permit axial movement of the needle; and

withdrawing the needle over the stylet to implant the seeds in the target tissue.

82. The method of claim 81, wherein the housing further selectively engages the stylet to selectively fix the stylet against axial movement when the stylet is rotated into engagement with the housing, and the stylet is rotated to engage the stylet with the housing prior to withdrawing the needle.

83. The method of claim 82, wherein rotating the stylet also axially advances the stylet.

84. The method of claim 83, wherein rotating the stylet to engage the housing and axially advance the stylet also rotates the needle to disengage it from the housing.

85. A method of performing a brachytherapy treatment using an instrument, the instrument comprising:

a hollow needle having a needle tip that defines a distal end of the instrument, a needle shaft that defines a central axis of the instrument and a needle extension portion joined to the proximal end of the needle shaft, the needle shaft containing seeds to be implanted within a patient'"'"'s body;

a stylet inserted through the needle extension portion and into the needle shaft, the stylet having a distal end in contact with a most proximal seed and a proximal end with a stylet hub adjacent the needle extension portion;

a housing extending partially around the central axis and within which the needle extension portion and the stylet hub are rotatably coupled, the housing having a distal end through which the needle shaft extends and a proximal end through which the needle extension portion extends;

the method comprising;

advancing the instrument in an axial direction to insert the needle into the body;

engaging the stylet with the housing to cause the stylet to advance in the axial direction relative to the needle by a predetermined distance to implant the most distal seed;

disengaging the needle from the housing; and

retracting the needle in the axial direction relative to the stylet and the housing, which remain stationary, to implant remaining seeds.

86. The method of claim 85, wherein advancing the instrument comprises advancing the instrument in the axial direction into contact with a stop that is positioned at a predetermined location to prevent further axial movement of the instrument.

87. The method of claim 85, wherein advancing the instrument comprises advancing the instrument in an axial direction to insert the needle tip to a predetermined over-insertion depth, retracting the instrument in the axial direction, and advancing the instrument to insert the needle tip to an insertion depth less than the over-insertion depth.

88. The method of claim 87, wherein advancing the instrument comprises advancing the instrument such that the housing contacts a stop positioned at a predetermined location with the distal end of the housing advanced beyond the stop to position the needle tip to a predetermined over-insertion depth, retracting the instrument in the axial direction and re-advancing the instrument such that the distal end of the housing contacts the stop to position the needle at the insertion depth.

89. The method of claim 85, wherein engaging the stylet with the housing comprises rotating the stylet relative to the housing, and wherein the stylet advances in the axial direction during the rotation.

90. The method of claim 89, wherein rotating the stylet rotates the needle relative to the housing.

91. The method of claim 85, wherein engaging the stylet with the housing comprises rotating the needle extension portion relative to the housing, which in turn rotates that stylet relative to the housing and causes the stylet to advance in the axial direction.