WO2000038579A9 - Device and method for safe location and marking of a cavity and sentinel lymph nodes - Google Patents

Device and method for safe location and marking of a cavity and sentinel lymph nodes

Info

Publication number
WO2000038579A9
WO2000038579A9 PCT/US1999/030619 US9930619W WO0038579A9 WO 2000038579 A9 WO2000038579 A9 WO 2000038579A9 US 9930619 W US9930619 W US 9930619W WO 0038579 A9 WO0038579 A9 WO 0038579A9
Authority
WO
WIPO (PCT)
Prior art keywords
cavity
marking device
marldng
marker
marking
Prior art date
Application number
PCT/US1999/030619
Other languages
French (fr)
Other versions
WO2000038579A3 (en
WO2000038579B1 (en
WO2000038579A2 (en
Inventor
D Laksen Sirimanne
Natalie V Fawzi
Douglas S Sutton
Gail S Lebovic
Stanley R Conston
Peter M Wilson
Anne B Morrissey
Mary Elizabeth Bush
Original Assignee
Vivant Medical Inc
D Laksen Sirimanne
Natalie V Fawzi
Douglas S Sutton
Gail S Lebovic
Stanley R Conston
Peter M Wilson
Anne B Morrissey
Mary Elizabeth Bush
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/285,329 external-priority patent/US6356782B1/en
Application filed by Vivant Medical Inc, D Laksen Sirimanne, Natalie V Fawzi, Douglas S Sutton, Gail S Lebovic, Stanley R Conston, Peter M Wilson, Anne B Morrissey, Mary Elizabeth Bush filed Critical Vivant Medical Inc
Priority to EP99968528A priority Critical patent/EP1152696B1/en
Priority to AU25924/00A priority patent/AU774994B2/en
Priority to US09/869,282 priority patent/US9669113B1/en
Priority to DE69921508T priority patent/DE69921508T2/en
Priority to AT99968528T priority patent/ATE280537T1/en
Priority to CA2356890A priority patent/CA2356890C/en
Priority to PCT/US2000/018394 priority patent/WO2001008578A1/en
Priority to AU60702/00A priority patent/AU6070200A/en
Publication of WO2000038579A2 publication Critical patent/WO2000038579A2/en
Publication of WO2000038579A3 publication Critical patent/WO2000038579A3/en
Publication of WO2000038579B1 publication Critical patent/WO2000038579B1/en
Publication of WO2000038579A9 publication Critical patent/WO2000038579A9/en
Priority to US12/777,710 priority patent/US9492570B2/en
Priority to US13/604,111 priority patent/US20130066195A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/006—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3987—Applicators for implanting markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3995—Multi-modality markers

Abstract

Cavity and sentinel lymph node marking devices, marker delivery devices, and methods are disclosed. 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, mammography, echogenic, or other noninvasive imaging techniques. A composition and method are disclosed for locating the sentinel lymph node in a mammalian body to determine if cancerous cells have spread thereto. The composition is preferably a fluid composition consisting of a carrier fluid and some type of contrast agent; alternatively, the contrast agent may itself be a fluid and therefore not need a separate carrier fluid. This composition is capable of (1) deposition in or around a lesion and migration to and accumulation in the associated sentinel node, and (2) remote detection via any number of noninvasive techniques. Also disclosed is a method for remotely detecting the location of a sentinel node by (1) depositing a remotely detectable fluid in or around a lesion for migration to and accumulation in the associated sentinel node and (2) remotely detecting the location of that node with a minimum of trauma and toxicity to the patient. The composition and method may serve to mark a biopsy cavity, as well as mark the sentinel lymph node. The marking methods also may combine any of the features as described with the marking device and delivery device.

Claims

We claim as our invention:
1. A subcutaneous cavity marking device comprising: at least one filler body comprising a resilient bioabsorbable material; and at least one detectable marker attached to said filler body.
2. The marking device of claim 1 wherein said at least one marker comprises a nonbioabsorbable material.
3. The marking device of claim 2 wherein said 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 marldng device of claim 1 wherein said at least one marker comprises a second bioabsorbable material.
5. The marldng device of claim 4 wherein said second bioabsorbable material comprises a polymer having a radiopaque additive.
6. The marking device of claim 5 wherein said 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 marking device of claim 1 wherein said at least one marker is radiopaque.
8. The marking device of claim 1 wherein said at least one body is radiopaque.
9. The marking device of claim 1 wherein said at least one marker is echogenic.
10. The marking device of claim 1 wherein said at least one body is echogenic.
11. The marldng device of claim 1 wherein said at least one marker is mammographic.
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12. The marldng device of claim 1 wherein said at least one body is mammographic.
13. The marldng device of claim 1 wherein said at least one body is palpable.
14. The marking device of claim 1 wherein said filler body further comprises a palpable shell.
15. The marking device of claim 14 wherein said shell is bioabsorbable and degrades when implanted within a patient's body, after said shell degrades said shell is no longer palpable.
16. The marking device of claim 14 wherein said shell is configured to degrade over a period of time.
17. The marking device of claim 16 wherein said period is less than 1 year.
18. The marking device of claim 16 wherein said period is between 2 and 6 months.
19. The marking device of claim 16 wherein said period is about 3 months.
20. The marking device of claim 1 wherein after insertion of said marking device into a patient said marker is not locatable by tactile detection.
21. The marldng device of claim 1 wherein after a period of time said body is not palpable.
22. The marldng device of claim 21 wherein said period of time is approximately 3 months.
23. The marking device of claim 1 wherein said marker is located within an interior of said at least one body.
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24. The marking device of claim 1 wherein said marker is substantially located within a geometric center of said at least one body.
25. The marking device of claim 1 additionally comprising a pain killing substance.
26. The marldng device of claim 1 additionally comprising a hemostatic substance.
27. The marldng device of claim 1 wherein said filler body is hemostatic.
28. The marking device of claim 1 wherein said bioabsorbable material is selected from the group consisting of collagen, regenerated cellulose, synthetic polymers and synthetic proteins.
29. The marking device of claim 28 wherein said synthetic polymer is chosen from the group consisting of poly ε-caprolactone, PGA, PL A, and copolymers thereof.
30. The marking device of claim 1 wherein said marker has a substantially spherical form.
31. The marldng device of claim 1 wherein said marker is hollow.
32. The marldng device of claim 1 wherein said marker has a form of a band.
33. The marldng device of claim 1 wherein said filler body comprises a threadlike material.
34. The marking device of claim 33 wherein said threadlike material has a preferred shape.
35. The marldng device of claim 34 wherein said threadlike material was heated to set said preferred shape.
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36. The marking device of claim 33 wherein said threadlike material is a suture material.
37. The marking device of claim 33 wherein said threadlike material passes through said at least one marker and forms at least one loop.
38. The marldng device of claim 37 where each said loop is longitudinally folded forming an opposing member located at an end of said loop opposite to said marker.
39. The marking device of claim 33 wherein said threadlike material passes through said at least one marker and forms at least one pair of opposing loops.
40. The marldng device of claim 39 wherein said threadlike material passes through said at least one marker and forms two pairs of opposing loops.
41. The marldng device of claim 39 where each loop of said pair of loops is longitudinally folded, said folded loop forming an opposing member located at an end of the loop opposite to said marker.
42. The marking device of claim 1 wherein said marker comprises a wire.
43. The marking device of claim 1 wherein said marker has at least one distinguishing mark.
44. The marking device of claim 43 wherein said distinguishing mark comprises alphanumeric characters.
45. The marldng device of claim 43 wherein said distinguishing mark can be viewed in 2 or more orientations.
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46. The marking device of claim 43 wherein said distinguishing mark can be modified at implant.
47. The marking device of claim 1 wherein said marker is fixedly attached to said at least one body.
48. The marldng device of claim 47 wherein said marker is woven to said at least one body.
49. The marldng device of claim 1 wherein said marker is radioactive.
50. The marking device of claim 1 wherein said at least one body is radioactive.
51. The marldng device of claim 1 wherein said at least one body is substantially spherical.
52. The marking device of claim 1 wherein said at least one body is substantially cylindrical.
53. The marking device of claim 1 wherein said at least one body is has a substantially irregular shape.
54. The marldng device of claim 1 wherein said at least one body comprises a biocompatible gel.
55. The marking device of claim 1 wherein said at least one body comprises a plurality of pores.
56. The marking device of claim 1 wherein said pores are configured to promote tissue growth in a preferred orientation.
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57. The marking device of claim 1 wherein said at least one filler body additionally comprises a biocompatible liquid.
58. The marldng device of claim 57 wherein said biocompatible fluid is nonivasively detectable and is configured to migrate to a lymph node.
59. The marldng device of claim 57 wherein said biocompatible fluid is visually detectable and is configured to migrate to a lymph node.
60. A subcutaneous cavity marking device comprising: at least one filler body comprising a nonbioabsorbable suture material; and at least one radiopaque marker substantially located within a geometric center of said filler body.
61. A subcutaneous cavity marking device comprising a plurality of resilient bioabsorbable filler bodies, at least two of which are connected by at least one marker.
62. The marking device of claim 61 wherein said at least one marker is suspended through the interior of at least one of said plurality of filler bodies.
63. The marldng device of claim 61 wherein said at least one marker is attached substantially to an outer perimeter of at least one of said plurality of bodies.
64. An implantable marking device comprising: a bioabsorbable body, said body being palpable for a period of time until absorbed by a patient's body, and a permanently detectable marker within said biodegradable body, said marker being substantially nonpalpable after placement of tlie marldng device in the patient's body.
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65. A composition for locating a sentinel node comprising nontoxic, non-radioactive microparticles configured to migrate from an insertion site to a lymph node in less than 3 hours and said microparticles being noninvasively detectable.
66. The composition of claim 65 and further including a visible dye wherein said dye renders the lymph node detectable under direct visualization.
67. The composition of claim 65 and further including carbon particles.
68. The composition of claim 65 wherein said microparticles are configured to migratefrom the insertion site to a lymph node in 5 to 20 minutes.
69. The composition of claim 65 wherein said microparticles are echogenic.
70. The composition of claim 65 wherein said microparticles are radiopaque.
71. The composition of claim 69 wherein said microparticles are hollow.
72. The composition of claim 70 wherein said hollow microparticles are filled with air, CO , nitrogen, or a fluorinated gas.
73. The composition of claim 64 wherein said microparticles contain silicon or a silicon compound.
74. The composition of claim 73 wherein said microparticles contain silicone.
75. The composition of claim 73 wherein said microparticles contain SiO2.
76. The composition of claim 65 wherein a diameter of said microparticles is between 0.05 microns and 5 microns.
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77. The composition of claim 65 wherein said microparticles are generally uniform in size to migrate to the sentinel node during a narrow time window.
78. The composition of claim 65 wherein said microparticles are permanently implantable.
79. A cavity marking delivery device comprising: a disengaging arm having a distal and a proximal end; a cartridge having a delivery lumen, said cartridge being slidable upon said disengaging arm and having a fixable position between said distal and proximal ends of said disengaging arm, said cartridge having an end portion extending beyond said distal end of said disengaging arm when said cartridge is placed in said fixable position; and a cavity marldng device locatable within said delivery lumen in adjacent to said end portion.
80. The delivery device of claim 79 where said cartridge has a proximal position adjacent to said proximal end of said disengaging arm, where said end portion of said cartridge is substantially adjacent to said distal end of said disengaging arm when said cartridge is in said proximal position.
81. The delivery device of claim 79 further comprising a sheath removably locatable about said cartridge.
82. The delivery device of claim 81 wherein said sheath has a fixable position along said cartridge between said distal end of said disengaging arm and said fixable position of said cartridge.
83. The delivery device of claim 79 wherein said cavity marking device is configured to have a significant frictional fit witliin said cartridge.
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84. A delivery device for delivering a marking device to a target site, said delivery device comprising: an elongate member having a distal portion and a proximal portion, said distal portion of said elongate member configured to seat the marking device and advance the marking device with said distal portion to the target site; and an ejector coupled to said elongate member, said ejector configured to disengage the marking device from said distal portion.
85. The delivery device of claim 84 for use with a medical instrument having a probe, said delivery device further comprising: an outer sheath having an open proximal end, an open distal end, and a lumen therethrough, wherein said outer sheath lumen is sized to fit over at least a portion of the probe; wherein said elongate member comprises a lumen extending through said distal and proximal portions of said elongate member, said elongate member being sized for insertion through said outer sheath lumen; and said ejector comprises a plunger slidable within said lumen of said elongate member.
86. The delivery device of claim 85 wherein said outer sheath further comprises a side port located between said open proximal end and said open distal end and sized for allowing said elongate member to enter through said side port to access said outer sheath lumen.
87. The delivery device of claim 86 wherein said plunger is flexible to bend through said side port.
88. The delivery device of claim 85 and further comprising a safety lock having a first position that prevents said plunger from moving and a second position that allows movement of said plunger.
89. The delivery device of claim 85 and further comprising a stop that allows said elongate member to travel only a predetermined distance through said outer sheath.
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90. The delivery device of claim 85 and further comprising a guide adapted for locking said outer sheath in place with respect to a desired marking site of a patient.
91. The delivery device of claim 90 wherein said guide attaches to a stereotactic table on which the patient lies.
92. The delivery device of claim 85 wherein at least a portion of said outer sheath is radiopaque or echogenic.
93. The delivery device of claim 85 wherein said outer sheath lumen has a diameter of about 2 to 5 mm.
94. The delivery device of claim 84 for use with a medical instrument having a cannula and a side window, wherein said elongate member comprises a flexible shaft portion between said proximal and distal portions; and said ejector is located witliin said distal end portion and has a first position fitted to carry a marking device through the cannula and a second position adapted to eject the marking device in a direction lateral to said flexible shaft portion.
95. The delivery device of claim 94 wherein said ejector comprises one or more hinges.
96. The delivery device of claim 94 wherein said delivery device consists of one molded piece.
97. The delivery device of claim 94 wherein said delivery device is machined from only one piece of material.
98. The delivery device of claim 94 wherein said flexible shaft portion has a smaller diameter than the largest diameter of said distal end portion.
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99. The delivery device of claim 94 wherein said flexible shaft portion comprises a first material, and said distal end portion comprises a second material, and said first material is more flexible than said second material.
100. The delivery device of claim 94 and further including a sheath and a plunger slidable witliin said sheath, wherein said flexible shaft portion comprises a portion of said sheath and a portion of said plunger.
101. The delivery device of claim 100 wherein said ejector comprises an expandable sleeve, wherein said first position comprises a collapsed position of said sleeve and wherein said second position comprises an expanded position of said sleeve and wherein said plunger further comprises an expander for expanding said sleeve.
102. The delivery device of claim 100 wherein said elongate member distal portion is U-shaped.
103. The delivery device of claim 100 wherein said expander comprises a solid.
104. The delivery device of claim 100 wherein said expander comprises a fluid.
105. The delivery device of claim 104 wherein said sleeve is sealed.
106. The delivery device of claim 104 wherein said sleeve is open and fluid can flow to the cavity.
107. The delivery device of claim 106 wherein said fluid is noninvasively detectable and configured to migrate to a lymph node.
108. The delivery device of claim 107 wherein said fluid is echogenic.
109. The delivery device of claim 101 wherein said sleeve comprises a high yield strength material.
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110. The delivery device of claim 94 wherein said distal end portion has a maximum cross sectional dimension of 1.5 to 4.5 mm.
111. The delivery device of claim 94 and further comprising a retainer.
112. The delivery device of claim 94 wherein said retainer is a transient retainer that cannot pass through the cannula.
113. The delivery device of claim 94 wherein said retainer comprises a tube.
114. The delivery device of claim 100 wherein said sheath further comprises a clip immovable thereon for rotationally stabilizing said delivery device with respect to the medical instrument.
115. The delivery device of claim 114 wherein said clip is adapted to be connected directly to the medical instrument.
116. The delivery device of claim 114 wherein said retainer further includes a hub having at least one feature for attaching to said clip, and wherein said retainer further includes a key fitted to lock into a keyway in the cannula.
117. The delivery device of claim 94 and further comprising a proximal handle portion having a rotational position indicator.
118. The delivery device of claim 117 wherein said proximal handle portion further comprises a cutout for mating with a portion of the medical instrument.
119. A marking system comprising: the delivery device of claim 84; and a marking device preloaded within said elongate member, for delivery through said delivery device.
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120. A marking system comprising: the delivery device of claim 94; and a marking device preloaded in said elongate member distal portion, for delivery through the cannula.
121. The marking system of claim 120 wherein said marking device comprises a compressed resilient material.
122. The marldng system of claim 120 wherein said marking device is compressed within said elongate member distal portion and has a compressed maximum cross sectional dimension of about 2.5 mm.
123. A delivery system comprising: the delivery device of claim 85; and a medical instrument having a probe sized to fit through said outer sheath.
124. A delivery system comprising: the delivery device of claim 94; and a medical instrument having a cannula having a side window wherein at least a portion of said delivery device is adapted to be slidable through said cannula.
125. The delivery system of claim 123 or 124 wherein said medical instrument comprises a biopsy probe.
126. A subcutaneous cavity marking device kit comprising: at least one cavity marldng device of claim 1; and a cavity marking delivery device as recited in claim 79 for deploying the cavity marldng device.
127. A kit comprising: the delivery device of claim 85;
62 a medical instrument having a probe sized to fit through said outer sheath; and at least one marking device for delivery through said delivery device.
128. A kit comprising: the delivery device of claim 94; a medical instrument having a cannula wherein at least a portion of said delivery device is adapted to be slidable through said cannula; and at least one marking device for delivery through said cannula.
129. The kit of claim 126 or 127 or 128 wherein said at least one marldng device includes a plurality of marking devices having different sizes and/or shapes.
130. A method of marking a tissue cavity comprising the steps of: suspending a marker within at least one filler body of resilient bioabsorbable material; and inserting the at least one filler body into the cavity.
131. The method of claim 130 wherein said inserting step precedes said suspending step.
132. The method of claim 130 wherein said step of inserting the at least one filler body into the cavity is performed percutaneously.
133. The method of claim 130 wherein the at least one filler body additionally comprises a hemostatic substance.
134. The method of claim 130 wherein the at least one filler body additionally comprises a pain-killing substance.
135. The method of claim 130 wherein the at least one filler body comprises a noninvasively detectable substance configured to migrate from said filler body to a sentinel lymph node.
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136. The method of claim 130 wherein the at least one filler body comprises a visually detectable substance configured to migrate from said filler body to a sentinel lymph node.
137. The method of claim 130 wherein the marker is radiopaque.
138. The method of claim 130 wherein the marker is echogenic.
139. The method of claim 130 wherein the at least one body is radiopaque.
140. The method of claim 130 wherein the at least one body is echogenic.
141. The method of claim 130 wherein the marker is fixedly attached to the at least one body.
142. The method of claim 130 and further including the step of: modifying the marldng device with an identifying code.
143. The method of claim 142 and further including the step of: entering data into a computer record; and indexing the computer record to tlie identifying code.
144. The method of claim 143 wherein said entering step is performed after said modifying step.
145. The method of claim 130 wherein the inserting step comprises: inserting a sheath in communication with the cavity; inserting the at least one filler body into a cartridge; advancing the cartridge into the sheath until a portion of the cartridge containing the at least one filler body is located within the cavity; and retracting the cartridge independently of the at least one filler body so that the at least one filler body remains in the cavity.
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SUBSTITUTE SHEET (RULE 26]
146. The method of claim 130 wherein said step of inserting the at least one filler body into the cavity is performed surgically.
147. The method of claim 131 wherein the at least one filler body comprises a gel, and wherein said step of inserting the at least one filler body into the cavity comprises filling the cavity with the gel, and further including the step of allowing the gel to at least partially solidify prior to said step of suspending the marker.
148. The method of claim 147 wherein the gel is inserted in powder form.
149. A method of marking a tissue cavity having a margin in a mammalian body, comprising: subcutaneously accessing the cavity via a delivery device, deploying a remotely detectable marldng device having a predetermined shape through the delivery device into the cavity, wherein upon delivery into the cavity the marldng device 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.
150. The method of claim 149 wherein at least a portion of the marldng device is bioabsorbable.
151. The method of claim 149 wherein at least a portion of the marldng device is radiopaque.
152. The method of claim 149 wherein at least a portion of the marking device is echogenic.
153. The method of claim 149 wherein the marldng device consists essentially of a wire.
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154. The method of claim 149 wherein the marking device comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof, and stainless steel.
155. The method of claim 149 wherein the marldng device is capable of emitting radioactive energy.
156. The method of claim 149 wherein the marking device comprises a helical coil.
157. The method of claim 149 wherein the marldng device defines a volume having a substantially spherical shape when the marldng device is deployed inside the cavity.
158. The method of claim 149 wherein the marking device defines a volume comprising a substantially cylindrical shape when the marker is deployed inside the cavity.
159. The method of claim 149 wherein the marking device defines a volume comprising a random shape when the marker is deployed inside the cavity.
160. The method of claim 153 wherein the wire comprises a shape memory material.
161. The method of claim 149 further comprising the step of introducing a biocompatible liquid in the marking device prior to said step of deploying the marking device.
162. The method of claim 161 wherein the delivery device uses a hydraulic force to deploy the marking device.
163. The method of claim 149 further comprising the step of introducing a biocompatible liquid in the marldng device subsequent to said step of deploying the marking device.
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164. The method of claim 163 wherein the biocompatible liquid is introduced to the marldng device via the delivery device.
165. The method of claim 149 and further comprising the step of: delivering a noninvasively detectable substance in the vicinity of said tissue cavity.
166. The method of claim 165 and further comprising the step of: allowing sufficient time for the noninvasively detectable substance to migrate to at least one lymph node; noninvasively detecting the substance in the at least one lymph node; and removing the at least one lymph node containing the detectable substance.
167. The method of claim 166 wherein said detecting step is done using ultrasound.
168. The method of claim 166 wherein said removing step is done percutaneously.
169. The method of claim 140 further comprising the step of introducing a sheath over the delivery device and into the cavity and wherein said deploying step further comprises the steps of: inserting the marking device into a cartridge; advancing the cartridge into the sheath until a portion of the cartridge containing the marldng device is in a desired position; and retracting the cartridge from the cavity independent of the marking device to deploy the marking device.
170. A method of marldng a tissue cavity comprising the steps of: suspending a marker within at least one filler body of bioabsorbable material; inserting a sheath in communication with the cavity; inserting the at least one filler body into a cartridge; advancing the cartridge into the sheath until a portion of the cartridge containing the at least one filler body is located within the cavity; and
67 retracting the cartridge independently of the at least one filler body so that the at least one filler body remains in the cavity.
171. A method of marldng a tissue cavity having a margin in a mammalian body, comprising the steps of: introducing a sheath over a delivery device; introducing the sheath and the delivery device into communication with the cavity; inserting a remotely detectable marker into a cartridge; advancing the cartridge into the delivery device until a portion of the cartridge containing the marker is in a desired position; and retracting the cartridge from the cavity independently of the marker to deploy the marker into the cavity wherein 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.
172. A method for delivering a marking device to a location in a body accessible by the probe of a medical instrument, said method comprising the steps of: inserting the probe into an outer sheath; accessing the location to be marked within the body with the probe; retracting tlie probe, leaving the outer sheath in communication with the location to be marked; inserting an applicator having an inner sheath and a plunger into the outer sheath; advancing the applicator through the outer sheath; pushing the plunger to deploy the marking device; removing the applicator; and removing the outer sheath.
173. The method of claim 172 wherein said removing steps are performed simultaneously.
174. The method of claim 172 and further comprising the step of: loading the marker into the applicator.
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175. The method of claim 172 and further comprising the step of: attaching a guide to the outer sheath; and attaching the guide to a point that is fixed with respect to the location to be marked within the body.
176. The method of claim 175 wherein said step of attaching a guide to the outer sheath comprises attaching the guide to a hub on the outer sheath.
177. The method of claim 176 wherein said attaching steps comprise: attaching the guide to a stereotactic table prior to said step of accessing a location to be marked within the body with the probe; sliding the guide toward the hub on the outer sheath after said step of accessing a location to be marked within the body with the probe; and connecting the guide to the hub.
178. The method of claim 177 wherein said step of attaching the guide to a stereotactic table comprises attaching the guide to an attachment on a stereotactic table.
179. The method of claim 172 and further comprising the step of removing a tissue sample with the probe.
180. The method of claim 172 wherein said step of inserting an applicator into the outer sheath comprises inserting the applicator through a side port of the outer sheath.
181. The method of claim 172 and further including the step of: pressing a safety tab on the applicator to release the plunger prior to said step of pushing the plunger.
182. The method of claim 172 wherein said step of advancing the applicator through the outer sheath comprises advancing the applicator until a stop on the inner sheath is reached.
69
183. A method for delivering a marking device through a side window of a medical instrument cannula having an open end proximal of the side window comprising the steps of: introducing the medical instrument cannula into tissue; inserting a distal end of a delivery device shaft and a marldng device through the open end of the cannula; advancing the shaft through the cannula until the distal end of the shaft and the marking device are in the region of the side window; and ejecting the marldng device through the side window while keeping the distal end of the shaft within the cannula.
184. The method of claim 173 and further including the steps of: compressing the marking device prior to advancing the shaft, and expanding the marldng device in volume during and/or after said ejecting step by 3 to 30 times its compressed volume.
185. The method of claim 183 and further including the steps of: compressing the marldng device prior to advancing the shaft, and expanding the marking device in volume during and/or after said ejecting step by 5 to 22 times its compressed volume.
186. The method of claim 183 and further including the steps of: compressing the marking device prior to advancing the shaft, and expanding the marking device in volume during and/or after said ejecting step by about 10 times its compressed volume.
187. The method of claim 183 and further including the steps of: compressing the marking device prior to advancing the shaft, and expanding the marking device in volume during and/or after said ejecting step to substantially fill the cavity.
70
188. The method of claim 183 and further including the steps of: compressing the marking device prior to advancing the shaft, and expanding the marking device in three dimensions.
189. The method of claim 184 wherein said expanding step comprises delivering a fluid to the marldng device.
190. The method of claim 184 wherein said expanding step comprises hydrating the marking device with body fluid.
191. The method of claim 189 wherein the fluid is echogenic and can migrate to a lymph node.
192. The method of claim 183 and further including the step of creating a cavity, wherein said step of ejecting the marking device through the side window includes ejecting the marking device into the cavity.
193. The method of claim 183, wherein said step of ejecting the marking device is performed atraumatically without clipping or piercing tissue with the marldng device.
194. The method of claim 183 wherein said steps of inserting and advancing are performed with the marldng device carried on a seat in the distal end of the shaft.
195. The method of claim 183 and further including the steps of substantially sealing the side window with the delivery device, and withdrawing the delivery device and cannula simultaneously.
196. The method of claim 183 wherein said ejecting step comprises pushing the shaft against a stop, causing an ejector seat to buckle, forcing the marking device through the side window.
71
197. The method of claim 183 wherein said ejecting step comprises expanding a sleeve to displace the marking device through the side window.
198. A method for marking a cavity comprising the steps of: inserting an implantable marking device through a small opening until the marking device encounters a cavity larger than the small opening; and expanding the marking device to define the borders of the cavity.
199. A method for locating a sentinel lymph node comprising: injecting a noninvasively detectable, non-radioactive, migratory contrast agent into the region of a cavity or lesion; allowing the contrast agent to migrate to a sentinel lymph node; and identifying the sentinel lymph node by noninvasively detecting the contrast agent in the sentinel lymph node.
200. The method of claim 199 and further including the step of removing at least a portion of tissue containing contrast agent.
201. The method of claim 199 wherein said injecting step comprises injecting the contrast agent directly into a biopsy or lumpectomy cavity.
202. The method of claim 200 wherein said removing step comprises perfonning fine needle aspiration.
203. The method of claim 200 wherein said removing step comprises perfonning core biopsy.
204. The method of claim 200 wherein said removing step comprises percutaneously removing the sentinel lymph node.
205. The method of claim 200 wherein said removing step comprises surgically removing the sentinel lymph node.
72
206. The method of claim 200 and further including the step of evaluating the removed tissue for cancer.
207. The method of claim 199 further including the step of assisting migration of the contrast by administering massage and or compression to the patient.
208. The method of claim 199 and wherein said allowing step comprises waiting a period of time for the contrast to migrate to between 1 and 3 lymph nodes before said identifying step.
209. The method of claim 206 and further including the step of noninvasively detecting a contrast agent in the patient's remaining lymph nodes after said evaluating step.
210. The method of claim 209 and further including the step of removing additional lymph nodes containing contrast agent detected after said evaluating step.
211. The method of claim 199 wherein the contrast agent is echogenic and wherein said detecting step comprises detecting the contrast agent using ultrasound.
212. The method of claim 199 wherein the contrast agent is detectable using MRI and wherein detecting step comprises detecting the contrast agent using MRI.
213. The method of claim 199 wherein the contrast agent is radiopaque and wherein said detecting step comprises detecting the contrast agent using X ray.
214. The method of claim 199 wherein the contrast agent is magnetic and wherein said detecting step comprises detecting the contrast agent using a Hall effect sensor or a magnetometer.
215. The method of claim 199 wherein the contrast agent is left in the patient for greater than one day.
73
216. The method of claim 199 wherein said waiting step comprises waiting about 5 to 3 hours between said injecting step and said detecting step.
217. The method of claim 199 wherein said allowing step comprises waiting about 5 to 20 minutes between said injecting step and said detecting step.
218. The method of claim 199 and further including the step of removing at least a portion of the lesion.
219. The method of claim 199 wherein said injecting step occurs before the cavity is created.
220. The method of claim 199 wherein said injecting step occurs after tlie cavity is created and comprises injecting the contrast agent into the created cavity.
221. A kit comprising: the marking device of claim 1 or 60 or 61; and the composition of claim 65.
222. The kit of claim 221 and further comprising the delivery device of claim 79 or 84.
223. N process for making a cavity marldng device comprising the steps of: placing a marker on a sheet of bioabsorbable material; and rolling or folding the sheet.
224. A process for making a cavity marking device comprising the steps of: • cutting a filler body material a into a shape; creating a hole at least partway through the filler body material; and placing at least one marker into the hole.
74
225. The process of claim 224 wherein said placing step comprises inserting a tube containing the at least one marker into the hole created by the needle and pushing the marker out of the tube and into the filler body.
75 AMENDED CLAIMS
[received by the International Bureau on 13 October 2000 (13.10.00); original claims 68, 72 and 73 amended; new claim 226 added; remaining claims unchanged (2 pages)]
65. A composition for locating a sentinel node comprising nontoxic, non-radioactive microparticles configured to migrate from an insertion site to a lymph node in less than 3 hours and said microparticles being noninvasively detectable.
66. The composition of claim 65 and further including a visible dye wherein said dye renders the lymph node detectable under direct visualization.
67. The composition of claim 65 and further including carbon particles.
68. The composition of claim 65 wherein at least some of said microparticles are configured to migrate from the insertion site to a lymph node in 5 to 20 minutes.
69. The composition of claim 65 wherein said microparticles are echogenic.
70. The composition of claim 65 wherein said microparticles are radiopaque.
71. The composition of claim 69 wherein said microparticles are hollow.
72. The composition of claim 71 wherein said hollow microparticles are filled with air, CO , nitrogen, or a fluorinated gas.
73. The composition of claim 65 wherein said microparticles contain silicon or a silicon compound.
74. The composition of claim 73 wherein said microparticles contain silicone.
75. The composition of claim 73 wherein said microparticles contain SiO .
76. The composition of claim 65 wherein a diameter of said microparticles is between 0.05 microns and 5 microns.
76
225. The process of claim 224 wherein said placing step comprises inserting a tube containing the at least one marker into the hole created by the needle and pushing the marker out of the tube and into the filler body.
226. The delivery device of claim 94 wherein said ejector first position is fitted to carry the marking device in contact with the cannula.
77
PCT/US1999/030619 1998-12-24 1999-12-23 Device and method for safe location and marking of a cavity and sentinel lymph nodes WO2000038579A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
EP99968528A EP1152696B1 (en) 1998-12-24 1999-12-23 Device and method for safe location and marking of a cavity and sentinel lymph nodes
AU25924/00A AU774994B2 (en) 1998-12-24 1999-12-23 Device and method for safe location and marking of a cavity and sentinel lymph nodes
US09/869,282 US9669113B1 (en) 1998-12-24 1999-12-23 Device and method for safe location and marking of a biopsy cavity
DE69921508T DE69921508T2 (en) 1998-12-24 1999-12-23 DEVICE AND METHOD FOR THE SAFE LOCALIZATION AND MARKING OF A CAVE AND SENTINELL LYMPHOTIC NODES
AT99968528T ATE280537T1 (en) 1998-12-24 1999-12-23 DEVICE AND METHOD FOR SAFE LOCATION AND MARKING OF A CAVITY AND SENTINAL LYMPH NODES
CA2356890A CA2356890C (en) 1998-12-24 1999-12-23 Device and method for safe location and marking of a cavity and sentinel lymph nodes
AU60702/00A AU6070200A (en) 1999-07-30 2000-07-03 Device and method for safe location and marking of a cavity and sentinel lymph nodes
PCT/US2000/018394 WO2001008578A1 (en) 1999-07-30 2000-07-03 Device and method for safe location and marking of a cavity and sentinel lymph nodes
US12/777,710 US9492570B2 (en) 1998-12-24 2010-05-11 Device and method for safe location and marking of a biopsy cavity
US13/604,111 US20130066195A1 (en) 1998-12-24 2012-09-05 Device and method for safe location and marking of a cavity and sentinel lymph nodes

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US22061898A 1998-12-24 1998-12-24
US09/220,618 1998-12-24
US09/285,329 US6356782B1 (en) 1998-12-24 1999-04-02 Subcutaneous cavity marking device and method
US09/285,329 1999-04-02
US09/347,185 US6371904B1 (en) 1998-12-24 1999-07-02 Subcutaneous cavity marking device and method
US09/347,185 1999-07-02

Related Parent Applications (1)

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US09/347,185 Continuation-In-Part US6371904B1 (en) 1998-12-24 1999-07-02 Subcutaneous cavity marking device and method

Related Child Applications (3)

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US09/869,282 A-371-Of-International US9669113B1 (en) 1998-12-24 1999-12-23 Device and method for safe location and marking of a biopsy cavity
US12/777,710 Continuation US9492570B2 (en) 1998-12-24 2010-05-11 Device and method for safe location and marking of a biopsy cavity
US13/604,111 Continuation US20130066195A1 (en) 1998-12-24 2012-09-05 Device and method for safe location and marking of a cavity and sentinel lymph nodes

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WO2000038579A3 WO2000038579A3 (en) 2000-12-21
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AT (2) ATE460116T1 (en)
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EP1491147A1 (en) 2004-12-29
EP1491147B1 (en) 2010-03-10
WO2000038579A3 (en) 2000-12-21
WO2000038579B1 (en) 2001-01-18
EP1152696A2 (en) 2001-11-14
AU2592400A (en) 2000-07-31
EP2174596B1 (en) 2012-05-30
US6371904B1 (en) 2002-04-16
CA2715331C (en) 2016-01-12
ATE460116T1 (en) 2010-03-15
DE69921508T2 (en) 2006-02-09
EP2174596A1 (en) 2010-04-14
ATE280537T1 (en) 2004-11-15
ES2340584T3 (en) 2010-06-07
DE69942132D1 (en) 2010-04-22
EP1152696B1 (en) 2004-10-27
CA2356890C (en) 2010-12-07
WO2000038579A2 (en) 2000-07-06
US20100234726A1 (en) 2010-09-16
CA2715331A1 (en) 2000-07-06
US9492570B2 (en) 2016-11-15
CA2356890A1 (en) 2000-07-06
AU774994B2 (en) 2004-07-15
DE69921508D1 (en) 2004-12-02

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