Subcutaneous cavity marking device and method

• US 6,356,782 B1
• Filed: 04/02/1999
• Issued: 03/12/2002
• Est. Priority Date: 12/24/1998
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Vivant Medical, Inc. (Johnson Controls International plc)
• Inventors: Sirimanne, D. Laksen, Lebovic, Gail, Fawzi, Natalie V., Sutton, Douglas S.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Lin, Jeoyuh
• Application Number:
  US09/285,329
• Time in Patent Office: 1,075 Days
• Field of Search: 600/407, 600/414, 600/420, 600/426, 600/431, 600/432, 600/436, 600/3, 600/4, 600/26.6, 600/36, 128/899, 623/1, 623/11, 623/12, 604/53, 604/265, 424/423, 424/426, 606/130, 606/194, 606/195
• US Class Current: 600/431
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/006 Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes

Abstract

These are subcutaneous cavity marking devices and methods. More particularly, upon insertion into a body, the cavity marking device and method enable one to determine the center, orientation, and periphery of the cavity by radiographic, mammographic, echogenic, or other non-invasive imaging techniques. Also, the device contains a bioabsorbable or non-bioabsorbable marker. The device may be combined with various substances enhancing the radiopaque, mammographic, or echogenic characteristics of the marker or the body allowing it to be observed by any non-invasive imaging techniques. This is further a method of marking a subcutaneous cavity using a bioabsorbable material and a bioabsorbable or non-bioabsorbable marker in conjunction with the material. The method also may combine any of the features as described with the device.

Claims

1. A subcutaneous cavity marking device comprising:

(a) at least one filler body comprising a resilient bioabsorbable material, and

(b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body, wherein said marker is mammographic.

2. The device of claim 1 wherein the at least one marker comprises a non-bioabsorbable material.

3. The device of claim 2 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.

4. The device of claim 1 wherein the at least one marker comprises a second bioabsorbable material.

5. The device of claim 4 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.

6. The device of claim 5 wherein the radiopaque additive is selected from the group consisting of barium-containing compounds, bismuth-containing compounds, powdered tantalum, powdered tungsten, barium carbonate, bismuth oxide, and barium sulfate.

7. The device of claim 1 wherein the at least one marker is radiopaque.

8. The device of claim 1 wherein the at least one body is radiopaque.

9. The device of claim 1 wherein the at least one marker is echogenic.

10. The device of claim 1 wherein the at least one body is echogenic.

11. The device of claim 1 wherein the at least one body is mammographic.

12. The device of claim 1 wherein the at least one body is palpable.

13. The device of claim 12 wherein after insertion of said device into a patient said marker is not locatable by tactile detection.

14. The device of claim 1 wherein the marker is located within an interior of the at least one body.

15. The device of claim 1 wherein the marker is substantially located within a geometric center of the at least one body.

16. The device of claim 1 additionally comprising a pain killing substance.

17. The device of claim 1 additionally comprising a hemostatic substance.

18. The device of claim 1 wherein the bioabsorbable material is selected from the group consisting of collagen, regenerated cellulose, synthetic polymers and synthetic proteins.

19. The device of claim 1 wherein the marker has a form of a sphere.

20. The device of claim 19 wherein the sphere is hollow.

21. The device of claim 1 wherein the marker has a form of a band.

22. The device of claim 1 wherein the marker comprises a suture.

23. The device of claim 1 wherein the marker comprises a wire.

24. The device of claim 1 wherein the marker has a distinguishing mark.

25. The device of claim 1 wherein the marker is fixedly attached to the at least one body.

26. The device of claim 25 wherein the marker is woven to the at least one body.

27. The device of claim 1 wherein the marker is radioactive.

28. The device of claim 1 wherein the at least one body is radioactive.

29. The device of claim 1 wherein the at least one body is substantially spherical.

30. The device of claim 1 wherein the at least one body is substantially cylindrical.

31. The device of claim 1 wherein the at least one body is has a substantially irregular shape.

32. The device of claim 1 wherein the at least one body comprises a plurality of pores.

33. The device of claim 32 wherein the pores are configured to promote tissue growth in a preferred orientation.

34. The device of claim 1 wherein the at least one filler body additionally comprises a bio-compatible liquid.

35. The device of claim 1 wherein said filler body further comprises a palpable shell.

36. The device of claim 35 wherein said shell is bioabsorbable and degrades when implanted within a patient'"'"'s body, after said shell degrades said shell is no longer palpable.

37. The device of claim 36 wherein said shell is configured to degrade over a period of time.

38. The device of claim 37 wherein said period of time is less than 1 year.

39. The device of claim 37 wherein said period of time is between 2 and 6 months.

40. The device of claim 37 wherein said period of time is about 3 months.

41. The device of claim 1 wherein after a period of time said body is not palpable.

42. The device of claim 41 wherein said period of time is approximately 3 months.

43. A subcutaneous cavity marking device comprising:

(a) at least one filler body comprising a resilient bioabsorbable material, wherein the at least one body is mammographic, and

(b) at least one detectable marker attached to said filler body and adapted to mark a center of said filler body.

44. The device of claim 43 wherein the at least one marker comprises a non-bioabsorbable material.

45. The device of claim 44 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.

46. The device of claim 43 wherein the at least one marker comprises a second bioabsorbable material.

47. The device of claim 46 wherein the second bioabsorbable material comprises a polymer having a radiopaque additive.

48. The device of claim 47 wherein the radiopaque additive is selected from the group consisting of barium-containing compounds, bismuth-containing compounds, powdered tantalum, powdered tungsten, barium carbonate, bismuth oxide, and barium sulfate.

49. The device of claim 43 wherein the at least one marker is radiopaque.

50. The device of claim 43 wherein the at least one body is radiopaque.

51. The device of claim 43 wherein the at least one marker is echogenic.

52. The device of claim 43 wherein the at least one body is echogenic.

53. The device of claim 43 wherein the at least one body is palpable.

54. The device of claim 53 wherein after insertion of said device into apatient said marker is not locatable by tactile detection.

55. The device of claim 43 wherein the marker is located within an interior of the at least one body.

56. The device of claim 43 wherein the marker is substantially located within a geometric center of the at least one body.

57. The device of claim 43 additionally comprising a pain killing substance.

58. The device of claim 43 additionally comprising a hemostatic substance.

59. The device of claim 43 wherein the bioabsorbable material is selected from the group consisting of collagen, regenerated cellulose, synthetic polymers and synthetic proteins.

60. The device of claim 43 wherein the marker has a form of a sphere.

61. The device of claim 60 wherein the sphere is hollow.

62. The device of claim 43 wherein the marker has a form of a band.

63. The device of claim 43 wherein the marker comprises a suture.

64. The device of claim 43 wherein the marker comprises a wire.

65. The device of claim 43 wherein the marker has a distinguishing mark.

66. The device of claim 43 wherein the marker is fixedly attached to the at least one body.

67. The device of claim 66 wherein the marker is woven to the at least one body.

68. The device of claim 43 wherein the marker is radioactive.

69. The device of claim 43 wherein the at least one body is radioactive.

70. The device of claim 43 wherein the at least one body is substantially spherical.

71. The device of claim 43 wherein the at least one body is substantially cylindrical.

72. The device of claim 43 wherein the at least one body is has a substantially irregular shape.

73. The device of claim 43 wherein the at least one body comprises a plurality of pores.

74. The device of claim 73 wherein the pores are configured to promote tissue growth in a preferred orientation.

75. The device of claim 43 wherein the at least one filler body additionally comprises a bio-compatible liquid.

76. The device of claim 43 wherein said filler body further comprises a palpable shell.

77. The device of claim 76 wherein said shell is bioabsorbable and degrades when implanted within a patient'"'"'s body, after said shell degrades said shell is no longer palpable.

78. The device of claim 77 wherein said shell is configured to degrade over a period of time.

79. The device of claim 78 wherein said period of time is less than 1 year.

80. The device of claim 78 wherein said period of time is between 2 and 6 months.

81. The device of claim 78 wherein said period of time is about 3 months.

82. The device of claim 43 wherein after a period of time said body is not palpable.

83. The device of claim 82 wherein said period of time is approximately 3 months.

84. A method of marking a tissue cavity having a margin in a mammalian body, comprising:

(a) subcutaneously accessing the cavity via a delivery device,

(b) introducing a biocompatible liquid in a remotely-detectable marker having a predetermined shape; and

thereafter

(c) deploying the marker through the delivery device into the cavity,

wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.

85. The method of claim 84 wherein the marker is bioabsorbable.

86. The method of claim 84 wherein the marker is radiopaque.

87. The method of claim 84 wherein the marker is echogenic.

88. The method of claim 84 wherein the marker comprises a wire.

89. The method of claim 85 wherein the wire comprises a shape memory material.

90. The method of claim 84 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.

91. The method of claim 84 wherein the marker is capable of emitting radioactive energy.

92. The method of claim 84 wherein the marker is a helical coil.

93. The method of claim 84 wherein the marker defines a volume having a substantially spherical shape when the marker is deployed inside the cavity.

94. The method of claim 84 wherein the marker defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.

95. The method of claim 84 wherein the marker defines a volume comprising a random shape when the marker is deployed inside the cavity.

96. The method of claim 84 wherein the delivery device uses a hydraulic force to deploy the marker.

97. The method of claim 84 wherein the delivery device comprises a biopsy device.

98. A method of marking a tissue cavity having a margin in a mammalian body, comprising:

(a) subcutaneously accessing the cavity via a delivery device,

(b) deploying a remotely detectable marker having a predetermined shape through the delivery device into the cavity, and thereafter

(c) introducing a biocompatible liquid in the marker,

wherein upon delivery into the cavity the marker assumes a predetermined three-dimensional configuration so to (1) substantially fill the cavity, (2) mark the cavity margin, and (3) indicate the orientation of the marker inside the cavity.

99. The method of claim 98 wherein the bio-compatible liquid is introduced to the marker via the delivery device.

100. The method of claim 98 wherein the marker is bioabsorbable.

101. The method of claim 98 wherein the marker is radiopaque.

102. The method of claim 98 wherein the marker is echogenic.

103. The method of claim 98 wherein the marker comprises a wire.

104. The method of claim 103 wherein the wire comprises a shape memory material.

105. The method of claim 104 wherein the marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.

106. The method of claim 104 wherein the marker is capable of emitting radioactive energy.

107. The method of claim 104 wherein the marker is a helical coil.

108. The method of claim 104 wherein the marker defines a volume having a substantially spherical shape when the marker is deployed inside the cavity.

109. The method of claim 104 wherein the marker defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.

110. The method of claim 104 wherein the marker defines a volume comprising a random shape when the marker is deployed inside the cavity.

111. The method of claim 104 wherein the delivery device comprises a biopsy device.