Methods and systems for marking post biopsy cavity sites

• US 7,744,852 B2
• Filed: 02/09/2007
• Issued: 06/29/2010
• Est. Priority Date: 07/25/2003
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical, LLC
• Inventors: Daniel, Sean Chris, Vetter, James W., Chernomorsky, Ary S.
• Primary Examiner(s): Henley, III; Raymond J
• Application Number:
  US11/673,510
• Publication Number:
  US 20070135711A1
• Time in Patent Office: 1,236 Days
• Field of Search: 424/1.37, 424/9.2, 424/471, 424/600
• US Class Current: 424/1.37
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A method of marking a cavity in a breast for subsequent visualization may include steps of providing a device having a delivery opening, a first marker and a second marker, the first and second markers being movable through the delivery opening, the first marker being configured to be visualized by ultrasound and the second marker configured to be radiopaque, the first and second markers being free to move relative to one another; introducing the device into a breast so that the delivery opening is positioned in a cavity formed in the breast; and moving the first marker and the second marker through the delivery opening and into the cavity in the breast, the first and second markers being free to move relative to one another when delivered into the cavity so that the first and second markers may take a number of different positions relative to one another when positioned within the cavity.

Claims

1. A device to deliver a soft tissue marker, comprising:

an introducer that defines an internal lumen;

a plurality of discrete substantially non-swellable elements disposed within the internal lumen, each being formed of at least one of a porous material and a non-porous material, and

a radiopaque element disposed within the internal lumen adjacent to at least one of the plurality of discrete substantially non-swellable elements, the radiopaque element being external to and uncoupled from each of the plurality of discrete substantially non-swellable elements.

2. The device of claim 1, wherein the porous material defines surfaces that form interconnected internal voids.

3. The device of claim 1, wherein the porous material defines internal surfaces that form internal voids and wherein a majority of the internal surfaces are common to more than one of the internal voids.

4. The device of claim 1, wherein the porous material defines surfaces that form primarily interconnected internal voids, as opposed to forming primarily entrapped discrete bubbles.

5. The device of claim 1, wherein the porous material has a controlled pore architecture with respect to at least one of pore density, pore shape, pore orientation and pore dimensions.

6. The device of claim 1, wherein at least one of the plurality of discrete substantially non-swellable elements has a degree of porosity that is different from a degree of porosity of another one of the plurality of discrete substantially non-swellable elements.

7. The device of claim 1, wherein both the porous material and the non-porous material are configured to promote echogenicity.

8. The device of claim 1, wherein the porous material of one of the plurality of discrete substantially non-swellable elements has a first controlled pore architecture and wherein the porous material of an other one of the plurality of discrete substantially non-swellable elements has a second controlled pore architecture that is different from the first controlled pore architecture.

9. The device of claim 8, wherein the first controlled pore architecture differs from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

10. The device of claim 1, wherein the porous material of the plurality of discrete substantially non-swellable elements is biodegradable.

11. The device of claim 1, wherein the porous material of at least one of the plurality of discrete substantially non-swellable elements includes at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLA-PGA), a polyglyconate, a polyanhydride, a lipid, a polysaccharide, and a polyorthoester.

12. The device of claim 1, wherein at least one of the plurality of discrete substantially non-swellable elements has a first shape and wherein an other one of the plurality of discrete substantially non-swellable elements has a second shape that is different from the first shape.

13. The device of claim 1, wherein at least one of the plurality of discrete substantially non-swellable elements has a substantially cylindrical shape.

14. The device of claim 1, wherein at least one of the plurality of discrete substantially non-swellable elements has a substantially rectangular shape.

15. The device of claim 1, wherein the radiopaque element is configured to appear clearly artificial when viewed under X-ray.

16. The device of claim 1, wherein the radiopaque element is configured to appear clearly artificial when viewed under ultrasound.

17. The device of claim 1, wherein the radiopaque element is formed of a non-ferrous metal.

18. The device of claim 1, wherein the radiopaque element includes a portion having a paramagnetic property.

19. The device of claim 1, further including more than one radiopaque element disposed within the internal lumen of the introducer.

20. The device of claim 1, wherein the plurality of discrete substantially non-swellable elements are configured to appear clearly artificial when viewed under ultrasound.

21. The device of claim 1, wherein a combination of the plurality of discrete substantially non-swellable elements and the radiopaque element are configured to appear clearly artificial when viewed under ultrasound.

22. A soft tissue marker for delivery to a biopsy site within a patient, comprising:

a plurality of discrete substantially non-swellable elements, each being formed of at least one of a porous material and a non-porous material, and

a radiopaque element disposed adjacent to at least one of the plurality of discrete substantially non-swellable elements, the radiopaque element being external to and uncoupled from each of the plurality of discrete substantially non-swellable elements.

23. The soft tissue marker of claim 22, wherein the porous material defines surfaces that form interconnected internal voids.

24. The soft tissue marker of claim 22, wherein the porous material defines internal surfaces that form internal voids and wherein a majority of the internal surfaces are common to more than one of the internal voids.

25. The soft tissue marker of claim 22, wherein the porous material defines surfaces that form primarily interconnected internal voids, as opposed to forming primarily entrapped discrete bubbles.

26. The soft tissue marker of claim 22, wherein the porous material has a controlled pore architecture with respect to at least one of pore density, pore shape, pore orientation and pore dimensions.

27. The soft tissue marker of claim 22, wherein at least one of the plurality of discrete substantially non-swellable elements has a degree of porosity that is different from a degree of porosity of another one of the plurality of discrete substantially non-swellable elements.

28. The soft tissue marker of claim 22, wherein both the porous material and the non-porous material are configured to promote echogenicity.

29. The soft tissue marker of claim 22, wherein the porous material of one of the plurality of discrete substantially non-swellable elements has a first controlled pore architecture and wherein the porous material of an other one of the plurality of discrete substantially non-swellable elements has a second controlled pore architecture that is different from the first controlled pore architecture.

30. The soft tissue marker of claim 29, wherein the first controlled pore architecture differs from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

31. The soft tissue marker of claim 22, wherein the porous material of the plurality of discrete substantially non-swellable elements is biodegradable.

32. The soft tissue marker of claim 22, wherein the porous material of at least one of the plurality of discrete substantially non-swellable elements includes at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLA-PGA), a polyglyconate, a polyanhydride, a lipid, a polysaccharide, and a polyorthoester.

33. The soft tissue marker of claim 22, wherein at least one of the plurality of discrete substantially non-swellable elements has a first shape and wherein an other one of the plurality of discrete substantially non-swellable elements has a second shape that is different from the first shape.

34. The soft tissue marker of claim 22, wherein at least one of the plurality of discrete substantially non-swellable elements has a substantially cylindrical shape.

35. The soft tissue marker of claim 22, wherein at least one of the plurality of discrete substantially non-swellable elements has a substantially rectangular shape.

36. The soft tissue marker of claim 22, wherein the radiopaque element is configured to appear clearly artificial when viewed under X-ray.

37. The soft tissue marker of claim 22, wherein the radiopaque element is configured to appear clearly artificial when viewed under ultrasound.

38. The soft tissue marker of claim 22, wherein the radiopaque element is formed of a non-ferrous metal.

39. The soft tissue marker of claim 22, wherein the radiopaque element includes a portion having a paramagnetic property.

40. The soft tissue marker of claim 22, further including more than one radiopaque element disposed within the internal lumen of the introducer.

41. The soft tissue marker of claim 22, wherein the plurality of discrete substantially non-swellable elements are configured to appear clearly artificial when viewed under ultrasound.

42. The soft tissue marker of claim 22, wherein a combination of the plurality of discrete substantially non-swellable elements and the radiopaque element are configured to appear clearly artificial when viewed under ultrasound.

43. A method for marking a biopsy site within a patient, comprising the steps of:

providing a device having a proximal end, an open distal end, an internal lumen and a piston that is movable within the internal lumen;

a plurality of discrete substantially non-swellable elements disposed within the internal lumen, each of which being formed of at least one of a porous material and a non-porous material, and a radiopaque element disposed within the internal lumen adjacent to at least one of the plurality of discrete substantially non-swellable elements, the radiopaque element being external to and uncoupled from each of the plurality of discrete substantially non-swellable porous elements;

introducing the distal end of the device into the biopsy site, and

advancing the piston in a distal direction so that the plurality of discrete substantially non-swellable elements and the radiopaque element are pushed out the open distal end of the device and into the biopsy site.

44. The method of claim 43, wherein the providing step is carried out with the porous material defining surfaces that form interconnected internal voids.

45. The method of claim 43, wherein the providing step is carried out with the porous material defining internal surfaces that form internal voids and wherein a majority of the internal surfaces are common to more than one of the internal voids.

46. The method of claim 43, wherein the providing step is carried out with the porous material defining surfaces that form primarily interconnected internal voids, as opposed to forming primarily entrapped discrete bubbles.

47. The method of claim 43, wherein the providing step is carried out with the porous material having a controlled pore architecture with respect to at least one of pore density, pore shape, pore orientation and pore dimensions.

48. The method of claim 43, wherein the providing step is carried out with at least one of the plurality of discrete substantially non-swellable elements having a degree of porosity that is different from a degree of porosity of another one of the plurality of discrete substantially non-swellable elements.

49. The method of claim 43, wherein the providing step is carried out with both the porous material and the non-porous material being configured to promote echogenicity.

50. The method of claim 43, wherein the providing step is carried out with the porous material of one of the plurality of discrete substantially non-swellable elements having a first controlled pore architecture and wherein the porous material of an other one of the plurality of discrete substantially non-swellable elements has a second controlled pore architecture that is different from the first controlled pore architecture.

51. The method of claim 50, wherein the providing step is carried out with the first controlled pore architecture differing from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

52. The method of claim 43, wherein the providing step is carried out with the porous material of the plurality of discrete substantially non-swellable elements being biodegradable.

53. The method of claim 43, wherein the providing step is carried out with the porous material of at least one of the plurality of discrete substantially non-swellable elements including at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLA-PGA), a polyglyconate, a polyanhydride, a lipid, a polysaccharide, and a polyorthoester.

54. The method of claim 43, wherein the providing step is carried out with at least one of the plurality of discrete substantially non-swellable elements having a first shape and wherein an other one of the plurality of discrete substantially non-swellable elements has a second shape that is different from the first shape.

55. The method of claim 43, wherein the providing step is carried out with at least one of the plurality of discrete substantially non-swellable elements having a substantially cylindrical shape.

56. The method of claim 43, wherein the providing step is carried out with at least one of the plurality of discrete substantially non-swellable elements having a substantially rectangular shape.

57. The method of claim 43, wherein the providing step is carried out with the radiopaque element being configured to appear clearly artificial when viewed under X-ray.

58. The method of claim 43, wherein the providing step is carried out with the radiopaque element being configured to appear clearly artificial when viewed under ultrasound.

59. The method of claim 43, wherein the providing step is carried out with the radiopaque element being formed of a non-ferrous metal.

60. The method of claim 43, wherein the providing step is carried out with the radiopaque element including a portion having a paramagnetic property.

61. The method of claim 43, wherein the providing step is carried out with the device further including more than one radiopaque element disposed within the internal lumen of the introducer.

62. The method of claim 43, wherein the providing step is carried out with the plurality of discrete substantially non-swellable elements being configured to appear clearly artificial when viewed under ultrasound.

63. The method of claim 43, wherein the providing step is carried out with a combination of the plurality of discrete substantially non-swellable elements and the radiopaque element being configured to appear clearly artificial when viewed under ultrasound.

64. A method of marking a cavity in a breast for subsequent visualization, comprising the steps of:

providing a device having a delivery opening, a first marker and a second marker, the first and second markers being movable through the delivery opening, the first marker being configured to be visualized by ultrasound and the second marker configured to be radiopaque, the first and second markers being free to move relative to one another;

introducing the device into a breast so that the delivery opening is positioned in a cavity formed in the breast; and

moving the first marker and the second marker through the delivery opening and into the cavity in the breast, the first and second markers being free to move relative to one another when delivered into the cavity so that the first and second markers may take a number of different positions relative to one another when positioned within the cavity.

65. The method of claim 64, wherein the providing step is carried out with the first marker being a polymer having a porous structure which enhances visibility of the first marker under ultrasound, the second marker being a metallic structure which enhances visibility of the second marker under x-ray.

66. The method of claim 64, wherein the providing step is carried out with the first marker being substantially non-swellable.

67. The method of claim 64, wherein the providing step is carried out with the first marker being uncoupled from the second marker.

68. The method of claim 64, wherein the providing step is carried out with the first marker including surfaces that form interconnected internal voids.

69. The method of claim 64, wherein the providing step is carried out with the first marker defining internal surfaces that form internal voids and wherein a majority of the internal surfaces are common to more than one of the internal voids.

70. The method of claim 64, wherein the providing step is carried out with the first marker defining surfaces that form primarily interconnected internal voids, as opposed to forming primarily entrapped discrete bubbles.

71. The method of claim 64, wherein the providing step is carried out with the first marker being porous and having a controlled pore architecture with respect to at least one of pore density, pore shape, pore orientation and pore dimensions.

72. The method of claim 64, wherein the providing step is carried out with the device including a third marker configured to be visualized by ultrasound, wherein the first and third markers are porous, and wherein the first marker has a degree of porosity that is different from a degree of porosity of the third marker.

73. The method of claim 64, wherein the providing step is carried out with the device including a third marker configured to be visualized by ultrasound, wherein the first marker has a first controlled pore architecture and the third marker has a second controlled pore architecture, and wherein the first controlled pore architecture is different from the second controlled pore architecture.

74. The method of claim 73, wherein the providing step is carried out with the first controlled pore architecture differing from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

75. The method of claim 64, wherein the providing step is carried out with the first marker being biodegradable.

76. The method of claim 64, wherein the providing step is carried out with the first marker including at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLA-PGA), a polyglyconate, a polyanhydride, a lipid, a polysaccharide, and a polyorthoester.

77. The method of claim 64, wherein the providing step is carried out with the first marker having a first shape and with the second marker having a second shape that is different from the first shape.

78. The method of claim 64, wherein the providing step is carried out with the device including a third marker configured to be visualized by ultrasound, the third marker being free to move relative to the first and second markers.

79. The method of claim 64, wherein the providing step is carried out with the third marker having a different shape than the first marker.

80. The method of claim 64, wherein the providing step is carried out with the first marker having a substantially cylindrical shape.

81. The method of claim 64, wherein the providing step is carried out with the first marker having a substantially rectangular shape.

82. The method of claim 64, wherein the providing step is carried out with the second marker being configured to appear clearly artificial when viewed under X-ray.

83. The method of claim 64, wherein the providing step is carried out with the second marker also being to appear clearly artificial when viewed under ultrasound.

84. The method of claim 64, wherein the providing step is carried out with the second marker including a non-ferrous metal.

85. The method of claim 64, wherein the providing step is carried out with the second marker including a portion having a paramagnetic property.

86. The method of claim 64, wherein the providing step is carried out with the device further a third marker that is configured to be radiopaque.

87. The method of claim 86, wherein the third marker is free to move relative to the first and second markers.

88. The method of claim 64, wherein the providing step is carried out with the first and second markers being configured to appear clearly artificial when viewed under ultrasound.

89. The method of claim 64, wherein the providing step is carried out with a combination of the first and second markers being configured to appear clearly artificial when viewed under ultrasound.

90. A soft tissue marker for delivery to a cavity within a patient, comprising:

a plurality of discrete echogenic and biodegradable elements;

a radiopaque element disposed adjacent to at least one and external to each of the plurality of discrete echogenic and biodegradable elements, and

a biodegradable string coupling at least some of the plurality of discrete echogenic and biodegradable elements.

91. The soft tissue marker of claim 90, wherein the biodegradable string is also coupled to the radiopaque element.

92. The soft tissue marker of claim 90, wherein the biodegradable string is a biodegradable suture.

93. The soft tissue marker of claim 90, wherein the biodegradable string includes vycril.

94. The soft tissue marker of claim 90, wherein the biodegradable string includes collagen.

95. The soft tissue marker of claim 90, wherein each of the plurality of discrete echogenic and biodegradable elements includes a porous material that defines surfaces that form interconnected internal voids.

96. The soft tissue marker of claim 90, wherein each of the plurality of discrete echogenic and biodegradable elements is substantially non-swellable.

97. A soft tissue marker for delivery to a cavity within a patient, comprising:

a plurality of discrete echogenic and biodegradable elements, each of the plurality of discrete echogenic and biodegradable elements defining a longitudinal axis and including at least one of a leading and a trailing surface that is inclined away from a normal to the longitudinal axis, and

a radiopaque element disposed adjacent to at least one and external to each of the plurality of discrete echogenic and biodegradable elements.

98. The soft tissue marker of claim 97, wherein each of the plurality of discrete echogenic and biodegradable elements includes a porous material that defines surfaces that form interconnected internal voids.

99. The soft tissue marker of claim 97, wherein each of the plurality of discrete echogenic and biodegradable elements is substantially non-swellable.

100. A soft tissue marker for delivery into a cavity within a patient, comprising:

a first echogenic and biodegradable element that defines a first plurality of crenellations that define a corresponding first plurality of locally thinner and thicker portions;

a second echogenic and biodegradable element that defines a second plurality of crenellations that define a corresponding second plurality of locally thinner and thicker portions, and

a radiopaque element disposed adjacent to at least one of the first and second echogenic and biodegradable elements and external to each of the first and second echogenic and biodegradable elements.

101. The soft tissue marker of claim 100, wherein each of the first and second echogenic and biodegradable elements includes a porous material that defines surfaces that form interconnected internal voids.

102. The soft tissue marker of claim 100, wherein each of the first and second echogenic and biodegradable elements is substantially non-swellable.

103. The soft tissue marker of claim 100, wherein the locally thinner portions are configured, when the marker is delivered into the cavity, to bend more than the locally thicker portions, thereby imparting a distinctive shape to the first and second echogenic and biodegradable elements within the cavity.