Apparatus and method for dose administration in brachytherapy

• US 7,041,048 B2
• Filed: 10/16/2002
• Issued: 05/09/2006
• Est. Priority Date: 10/16/2002
• Status: Active Grant

• Current Assignee: Stm Acquisition Sub., Inc.
• Original Assignee: Source Tech Medical, LLC (Becton, Dickinson & Co)
• Inventors: Drobnik, Michael W., Drobnik, Christopher D., Jones, Scott C., Sieracki, Dave
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/272,803
• Publication Number:
  US 20040077919A1
• Time in Patent Office: 1,301 Days
• Field of Search: 600/7, 600/8, 600/439, 600/1, 600 2- 6, 600/427, 600/431, 600/407, 600/434, 600/459, 604/60, 604/173, 604/57, 604/64, 604/891.1, 604/63, 604/59, 604/61, 604/62, 221/4, 128/920, 128/922, 250/506.1, 250/507.1, 348/7
• US Class Current: 600/7
• CPC Class Codes: A61N 2005/101 Magazines or cartridges for seeds
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

An apparatus and method for administering a dose in brachytherapy procedures having a handheld housing containing a dose of radioactive seeds adapted for use in a brachytherapy treatment and a display for observing information about the dose and viewing the dose or components of the dose.

Claims

1. An apparatus, comprising:

a housing;

a holder in the housing that contains a dose of radioactive seeds corresponding to a treatment plan;

a display for providing information for the dose according to the treatment plan;

wherein the treatment plan comprises a plurality of radioactive seeds;

wherein the housing comprises all of the plurality of radioactive seeds of the treatment plan;

wherein the dose of radioactive seeds comprises a plurality of component doses;

wherein each component dose comprises a needle load of one or more of the radioactive seeds;

wherein the dose is ejected from the holder in the housing into one or more needles.

2. The apparatus of claim 1, wherein the dose is contained in the housing in an order corresponding to the treatment plan.

3. The apparatus of claim 1, wherein the housing allows ejection of the dose in an order corresponding to the treatment plan.

4. The apparatus of claim 1 wherein the housing allows ejection of the seeds from the housing in an order corresponding to spatial coordinates required by the treatment plan.

5. The apparatus of claim 4, wherein the treatment plan comprises a distribution pattern of the dose in a predetermined quantity of tissue.

6. The apparatus of claim 1, wherein the holder comprises a cylinder that receives the dose.

7. The apparatus of claim 6, wherein the cylinder comprises grooves in an outer surface thereof that receive the dose.

8. The apparatus of claim 7, wherein the grooves have a generally U shaped cross-section.

9. The apparatus of claim 7, wherein the grooves have a cross-section comprising a generally circular portion inwardly of the outer surface of the cylinder with a channel connecting the circular portion with the surface of the cylinder.

10. The apparatus of claim 7, further comprising a sleeve surrounding the cylinder thereby restraining the dose in the grooves of the cylinder.

11. The apparatus of claim 7, further comprising:

a first gate at one end of the cylinder;

a second grate at an opposed end of the cylinder; and

wherein the first gate and the second gate restrain the dose within the grooves.

12. The apparatus of claim 11, wherein each of the first and second gates further comprises an elastomer.

13. The apparatus of claim 1, wherein the dose further comprises a plurality of component doses including at least one of discrete radioactive seeds and a continuous strand of radioactive seeds.

14. The apparatus of claim 1, wherein the information about the dose is an identity of one of the plurality of component doses.

15. The apparatus of claim 1, wherein the dose comprises a plurality of component doses and the holder comprises a cylinder having parallel grooves on a surface thereof with each groove receiving one of the plurality of component doses.

16. The apparatus of claim 15, further comprising a terminating member connected to an end of the housing, and the terminating member having a channel aligned selectively with each groove in the cylinder and adapted to be coupled to a needle.

17. The apparatus of claim 16, further comprising a wheel for rotating the cylinder for selective alignment of a selected one of the grooves with the channel in the terminating member.

18. The apparatus of claim 17, further comprising:

a barrel connected to the wheel and the cylinder and wherein the barrel includes information associated with each of the plurality of components doses;

a first display component that provides information about each of the plurality of component doses;

a second display component that discloses a one of the component doses next to be ejected from the housing; and

a lock member coupled to the wheel that secures the cylinder in a secured position for each of the plurality of component doses in association with the first display component and the second display component.

19. The apparatus of claim 17, further comprising:

first and second gates located at opposed ends of the grooves for restraining movement of the dose within the grooves; and

a stylus slidable through each gate of the first and second gates, the stylus contacting the dose to move the dose into the needle.

20. The apparatus of claim 1, further comprising a display that provides access to a sample of the dose for assaying the sample of the dose.

21. The apparatus of claim 1, wherein the housing comprises;

a nose;

a terminating member extending outwardly of the nose; and

an engaging member connected to the nose that brings a needle in a coupled relationship with the terminating member.

22. The apparatus of claim 1, wherein at least a portion of the housing comprises a radiation shielding material.

23. The apparatus of claim 1, further comprising a display for observing the dose in the housing without radioactive exposure.

24. The apparatus of claim 23, wherein the dose is viewable through an element that is substantially impervious to radioactive transmission.

25. The apparatus of claim 24, wherein the dose is viewable indirectly through the element.

26. The apparatus of claim 23, wherein the dose is viewable through a light pipe to avoid radioactive exposure.

27. The apparatus of claim 23, wherein the dose is viewable through a prism to avoid radioactive exposure.

28. The apparatus of claim 23, wherein the dose is viewable through a combination of mirrors to avoid radioactive exposure.

29. The apparatus of claim 24, wherein the dose comprises a plurality of component doses, and

wherein each component dose of the plurality of component doses is observable at the display.

30. The apparatus of claim 29, wherein each component dose of the plurality of component doses is observable prior to ejection according to the treatment plan.

31. The apparatus of claim 1, further comprising:

a needle grid in the housing; and

an adjustable indicator extending adjustably outwardly from the housing for measuring a distance between the housing and the needle grid and that allows a pre-selected distance of retraction of the housing to administer the dose at a predetermined location in a tissue.

32. The apparatus of claim 1, wherein the plurality of grooves retrains the dose of radioactive seeds.

33. The apparatus of claim 1, wherein the plurality of grooves are in a parallel relationship with each other and located at a surface of the cylinder, and wherein the cylinder is enclosed in a polycarbonate sleeve to retain the dose of radioactive seeds in the plurality of grooves.

34. The apparatus of claim 24, wherein the element comprises at least one of leaded glass and acrylic.

35. The apparatus of claim 1, wherein all of the plurality of radioactive seeds of the treatment plan are adminstered to a patient in a single medical procedure.

36. The apparatus of claim 1, wherein the housing is loaded with the plurality of radioactive seeds prior to shipment to a physician for administration of the plurality of radioactive seeds to the patient.

37. The apparatus of claim 1, wherein the information comprises spatial information.

38. The apparatus of claim 37, wherein the spatial information comprises rectangular spatial coordinates, three dimensional spatial coordinates, and/or a retraction distance associated with the dose.

39. The apparatus of claim 37, wherein the spatial information comprises rectangular coordinates and retraction distance associated with the dose.

40. An apparatus, comprising:

a housing;

a holder in the housing that contains a dose of radioactive seeds corresponding to a treatment plan; and

wherein the treatment plan comprises a plurality of radioactive seeds;

wherein the housing comprises all of the plurality of radioactive seeds of the treatment plan;

wherein the dose is ejected from the housing;

wherein the housing includes a sterilization passageway that allows sterilant to enter the housing for sterilization of the dose within the housing.

41. The apparatus of claim 40, wherein the sterilant comprises gamma radiation.

42. The apparatus of claim 40, wherein the sterilant comprises at least one of ethylene oxide gas and vaporized hydrogen peroxide.

43. The apparatus of claim 40, wherein the sterilant comprises pressurized steam.

44. A method, comprising the steps of:

arranging within a housing a dose for distribution in tissue in an order corresponding to a treatment plan, wherein the order corresponds to spatial coordinates of the dose that corresponds to the treatment plan;

administering the dose in the tissue from the housing in accordance with the treatment plan; and

indicating on the housing spatial coordinates for the dose according to the treatment plan.

45. The method of claim 44, further comprising the step of generating a treatment plan for distribution of a dose.

46. The method of claim 44, further comprising the step of indicating on the housing an identity of the dose.

47. The method of claim 44, further comprising the steps of indicating on the housing a location of a grid for the administration of a dose.

48. The method of claim 44, further comprising the step of indicating on the housing a retraction distance for the dose.

49. The method of claim 44, further comprising the step of measuring a retraction distance of a dose in accordance with the treatment plan.

50. The method of claim 44, further comprising the step of including within the housing the dose corresponding to the treatment plan for one or more patients.

51. The method of claim 44, further comprising the step of indicating on the housing three-dimensional coordinates of each of a plurality of radioactive seeds of the dose as specified in the treatment plan.

52. The method of claim 44, further providing the step of observing information about the dose at the housing without radioactive exposure.

53. The method of claim 44, further comprising the step of displaying through the housing a sample of the dose for assaying.

54. The method of claim 44, wherein the step of arranging further comprises the steps of:

arranging the dose in grooves on a cylinder in the housing;

selectively aligning the grooves with a channel in a stalk connected to the housing; and

moving at least a portion of the dose through the channel and into a needle aligned with the channel.

55. The method of claim 44, further comprising the step of controlling the housing with either a right hand or a left hand when administering the dose.

56. The method of claim 54, wherein the step of moving further comprises the step of moving the dose into tissue through the needle that is operatively coupled to the housing.

57. A method, comprising the steps of:

arranging a plurality of component doses according to an order of the treatment plan;

observing information about each of the plurality of component doses prior to ejection from the housing; and

loading a plurality of needles with the dose from the housing according to the treatment plan;

wherein the step of loading the plurality of needles with the dose from the housing according to the treatment plan comprises the steps of;

aligning the dose with a gated aperture in the housing;

moving the dose into the housing; and

automatically sealing the gated aperture after the dose is loaded in the housing.

58. The method of claim 57, further comprising the steps of:

engaging a hub of one of the plurality of needles to move the one of the plurality of needles in a coupled relationship with the housing; and

ejecting a portion of the dose into the one of the plurality of needles.

59. The method of claim 58, wherein the step of ejecting further comprises the steps of:

moving a stylus through a gate and through the housing to move the dose into a needle of the plurality of needles; and

automatically sealing the gate upon withdrawal of the stylus.

60. The method of claim 57, wherein the step of loading further comprises the step of loading a dose that is a continuous strand.

61. The method of claim 60, wherein the strand comprises at least one radioactive seed.

62. The method of claim 57, further comprising the step of controlling the housing with either a right hand or a left hand when loading the needle with the dose.

99. The method of claim 57, wherein the step of observing information about each of the plurality of component doses prior to ejection from the housing comprise the step of:

observing an identity of one of the plurality of component doses prior to ejection from the housing.

63. An apparatus, comprising:

a housing;

a holder in the housing that receives a dose for a treatment positioned in an order corresponding to a treatment plan;

a display on the housing and associated with the dose;

wherein the dose is ejected from the housing;

wherein the display comprises a first subcomponent display and a second subcomponent display;

wherein the first subcomponent display provides information for the dose according to the treatment plan;

wherein the second subcomponent display allows a user to indirectly view the dose without radioactive exposure.

64. The apparatus of claim 63, wherein the display is a slide button coupled to the housing and slidable between a first position and a second position and wherein in the first position, information about the dose is observable, and wherein in the second position access to the dose is provided to assay the dose.

65. The apparatus of claim 63, wherein the information about the dose comprises spatial information.

66. The apparatus of claim 63, wherein the dose comprises one of a plurality of component doses and the information comprises an identity of one of the plurality of component doses.

67. The apparatus of claim 63, wherein the dose that is observable at the second subcomponent display corresponds to an identity of the dose provided at the first subcomponent display.

68. The apparatus of claim 63, wherein the display has an access for assay of the dose.

69. The apparatus of claim 63, wherein the display comprises an element impervious to radioactive transmission;

and

wherein the dose is observable through a slot in the housing.

70. The apparatus of claim 63, wherein the dose associated with the display comprises a portion of a dose next in queue for ejection into a needle.

71. The apparatus of claim 64, wherein the display for access comprises a slide button that is slidably coupled to the housing, and wherein the slide button in a first restrained position provided access to assay the dose and in a second restrained position provides information about the dose.

72. The apparatus of claim 63, wherein the holder comprises:

a cylinder having a channel for containing the dose;

a barrel having a wheel and an end connected to the cylinder; and

wherein the barrel is coupled to the housing in a sliding relationship.

73. The apparatus of claim 72, wherein the barrel contains information about the dose that is observable at the display.

74. The apparatus of claim 73, wherein the information is on a surface of the barrel and accessible at the display by selective rotation of the wheel for observing information about the dose.

75. The apparatus of claim 73, wherein the dose comprises a plurality of component doses, and wherein the information accessible at the display corresponds to a one of the plurality of component doses of the treatment plan.

76. The apparatus of claim 63, further comprises:

the housing having a nose and a body, the nose of the housing extending from the body of the housing;

a terminating member comprising a base operatively connected to the housing and selectively engageable with the holder to selectively position the barrel in alignment with the display for providing access to information associated with the dose; and

a stalk extending away from the base and outwardly of an end of the nose; and

wherein the stalk includes a channel aligned with the holder to receive a dose ejected from the housing.

77. The apparatus of claim 76, further comprising an engaging member connected to the end of the housing for engaging an end of a needle to bring it into coupled relationship with an end of the stalk.

78. The apparatus of claim 77, wherein the engaging member further comprises:

an extendable connecting member; and

an actuator that guides the extendable connecting member to engagement with an end of the needle.

79. The apparatus of claim 78, wherein extension of the extendable member moves the extendable member away from the needle and retraction of the extendable member converges a forked end of the extendable member upon the needle near a hub of the needle and draws the hub of the needle in a coupled relationship with the stalk.

80. The apparatus of claim 72, further comprising:

an end cap connected to an end of the housing, the end cap having an annular shoulder extending inwardly of the end of the housing and relieving in a sliding coupled connection an end of the cylinder and a channel extending longitudinally through the end cap; and

the channel in the end cap axially aligned with the channel in the cylinder and the channel in the stalk defining a pathway for loading the dose in the housing and ejecting the dose from the housing.

81. The apparatus of claim 80, further comprising:

an automatically adjustable indicator extending longitudinally through the housing and having a thread end extending through the end cap and a spring biased extension member extending outwardly of an opposed end thereof and the nose of the housing to measure a retraction measurement associated with the dose.

82. The apparatus of claim 63, wherein the dose contained in the holder is positioned in an order corresponding to spatial coordinates of the dose that corresponds to the treatment plan.

83. The apparatus of claim 63, wherein the dose comprises a plurality of component doses, and wherein each dose of the plurality of component doses comprises a continuous linked strand having at least one radioactive seed and at least one spacer.

84. An apparatus, comprising:

a housing configured to be handheld in either a left or right hand;

a holder in the housing that contains a dose of radioactive seeds corresponding to a treatment plan;

wherein the treatment plan comprises a plurality of radioactive seeds;

wherein the housing comprises all of the plurality of radioactive seeds of the treatment plan;

wherein the ejection of the dose from the housing is effected according to the treatment plan.

85. The apparatus of claim 84, further comprising a guide on a surface of the housing for receiving a hand positioned to control the housing when loading a needle with the dose.

86. The apparatus of claim 85, wherein the guide comprises a pair of tapered portions defining an opposed pair of areas on the surface of the housing for receiving either a left hand or a right hand;

and

wherein the apparatus further comprises an actuator on the housing positioned for engagement with either the right hand or the left hand for connecting the needle to the housing.

87. An apparatus, comprising:

means for containing within a housing a plurality of component doses of radioactive seeds corresponding to a treatment plan, wherein the treatment plan comprises a plurality of radioactive seeds, wherein the housing comprises all of the plurality of radioactive seeds of the treatment plan;

means for displaying information for the dose according to the treatment plan and the one of the plurality of component doses prior to ejecting the one of the plurality of doses from the housing; and

means for ejecting one of the plurality of component doses from the housing.

88. The apparatus of claim 87, further comprising means for displaying information associated with the one of the plurality of component doses.

89. The apparatus of claim 87, further comprising means for restraining the plurality of component doses within the housing prior to and after ejecting the one of the plurality of component doses.

90. The apparatus of claim 87, wherein the means for ejecting comprises:

means for aligning the one of the component doses in a pathway extending through the housing; and

means for moving the one of the plurality of component doses through the pathway and out of the housing.

91. The apparatus of claim 90, comprising means for coupling the housing to a needle to receive the one of the plurality of component doses to be ejected from the housing.

92. The apparatus of claim 87, further comprising:

means for configuring the housing to be hand held with either the right hand or the left hand; and

means for controlling the housing with either the right hand or the left hand when connecting the housing to a needle and ejecting the one of the plurality of component doses from the housing.

93. The apparatus of claim 88, wherein the means for displaying information associated with the one of the plurality of component doses comprises:

means for displaying an identity of the one of the plurality of component doses.

94. An apparatus, comprising:

a housing;

a holder in the housing that contains a dose of radioactive seeds and adapted for use in a brachytherapy treatment plan;

wherein the holder comprises a cylinder having a plurality of grooves;

wherein the dose is ejected from the housing;

wherein the housing comprises a sterilization passageway that allows sterilant to enter the housing for sterilization of the dose within the housing.

95. An apparatus, comprising:

a housing;

a cylinder in the housing that contains a dose of radioactive seeds corresponding to a treatment plan, the dose comprising a plurality of component doses including at least one of discrete radioactive seeds and a continuous strand of radioactive seeds;

the cylinder having a grooves in an outer surface thereof receive the dose;

a sleeve surrounding the cylinder, the sleeve restraining the dose in the grooves of the cylinder;

a first gate at a first end of the cylinder and a second gate at a second end of the cylinder opposed from the first end of the cylinder, the first gate and the second gate restraining the dose within the grooves;

a terminating member connected to the first end of the housing, the terminating member having a channel aligned selectively with each groove in the cylinder and adapted to be coupled to at least one needle;

a first display component that provides spatial information for each of the plurality of component doses according to the treatment plan;

a second display component that discloses a one of the component doses next to be ejected from the housing.

96. An apparatus, comprising:

a housing;

a cylinder in the housing that contains a dose of radioactive seeds corresponding to a treatment plan, the dose comprising a plurality of component doses including at least one of discrete radioactive seeds and a continuous strand of radioactive seeds;

the cylinder having grooves in an outer surface thereof that receive the dose;

a sleeve surrounding the cylinder, the sleeve retraining the dose in the grooves of the cylinder;

a first gate at a first end of the cylinder and a second gate a second end of the cylinder opposed from the first end of the cylinder, the first gate and the second gate retraining the dose within the grooves;

a terminating member connected to the first end of the housing, the terminating member having a channel aligned selectively with each groove in the cylinder and adapted to be coupled to at least one needle;

a wheel for rotating the cylinder to effect selective alignment of a selected one of the grooves with the channel in the terminating member;

a barrel connected to the wheel and the cylinder, the barrel having information associated with each of the plurality of component doses;

a first display component that provides information about each of the plurality of component doses;

a second display component that discloses a one of the component doses next to be ejected from the housing; and

a lock member coupled to the wheel that secures the cylinder in a secured position for each of the plurality of component doses in association with the first display component and the second display component.

97. A method, comprising the steps of:

arranging in a housing a dose of radioactive seeds according to a treatment plan; and

loading a plurality of needles with the dose from the housing according to the treatment plan;

arranging a plurality of component doses according to an order of the treatment plan; and

observing information about each of the plurality of component doses prior to ejection from the housing;

engaging a hub of one of the plurality of needles to move the one of the plurality of needles in a coupled relationship with the housing; and

moving a stylus through a gate and through the housing to move the dose into a needle of the plurality of needles; and

automatically sealing the gate upon withdrawal of the stylus

ejecting a portion of the dose into the one of the plurality of needles.

98. A method, comprising the steps of:

moving, according to a treatment plan, a dose of radioactive seeds into a housing via a gated aperture, the dose including radioactive seeds and spacers in continuous strands;

automatically sealing the gated aperture after the dose is loaded in the housing;

assaying the radioactivity of at least one of the radioactive seeds to verify a correct arrangement of the dose in the housing according to the treatment plan; and

visually inspecting the dose via a display in the housing to verify a correct arrangement of the dose in the housing according to the treatment plan.