Noninvasive intraductal fluid sampling device
View Patent ↗Disclosed is an apparatus for noninvasive intraductal fluid aspiration. Intraductal fluid is noninvasively aspirated using compression, heating and suction cycles. The device is configured to provide a compression force, deliver heat, and apply a vacuum pressure to encourage the aspiration of patient fluid. The device includes an adjustable support and a movable wall for applying compression. Withdrawn fluid may be used either for diagnostic or therapeutic purposes.
1. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least three inflatable bladders within the concavity;
a vacuum source in communication with the concavity;
a heat source; and
a fluid circulation pathway for circulating a fluid through the bladders.
2. A nipple aspirate fluid aspiration device as in claim 1 , wherein each petal carries an inflatable bladder.
3. A nipple aspirate fluid aspiration device as in claim 1 , wherein the heat source is in thermally conductive contact with the bladder.
4. A nipple aspirate fluid aspiration device as in claim 1 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid heats the bladder.
5. A nipple aspirate fluid aspiration device as in claim 1 , further comprising a control for inflating and deflating the bladder in accordance with a predetermined program.
6. A nipple aspirate fluid aspiration device as in claim 5 wherein the predetermined program comprises alternating inflation and deflation cycles.
7. A nipple aspirate fluid aspiration device as in claim 6 wherein the predetermined program inflates the bladder within the range of from about 2 to about 40 cycles per minute.
8. A nipple aspirate fluid aspiration device as in claim 7 wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
9. A nipple aspirate fluid aspiration device as in claim 6 wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
10. A nipple aspirate fluid aspiration device as in claim 1 , wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
11. A nipple aspirate fluid aspiration device as in claim 10 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
12. A nipple aspirate fluid aspiration device as in claim 1 , wherein the bladder bas an inflated thickness of no more than about 1 inch.
13. A nipple aspirate fluid aspiration device as in claim 12 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
14. A nipple aspirate fluid aspiration device as in claim 1 , further comprising a central processing unit for controlling the inflatable bladders.
15. A nipple aspirate fluid aspiration device as in claim 1 , further comprising:
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
16. A nipple aspirate fluid aspiration device as in claim 15 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
17. A nipple aspirate fluid aspiration device as in claim 16 , wherein the bladder comprises at least 3 inflatable lobes.
18. A nipple aspirate fluid aspiration device as in claim 17 , comprising at least 6 inflatable lobes.
19. A nipple aspirate fluid aspiration device as in claim 17 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
20. A nipple aspirate fluid aspiration device as in claim 19 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
21. A nipple aspirate fluid aspiration device as in claim 16 , further comprising a heat exchange fluid contained within the closed loop.
22. A nipple aspirate fluid aspiration device as in claim 16 , further comprising a pump in the control unit.
23. A nipple aspirate fluid aspiration device as in claim 22 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
24. A nipple aspirate fluid aspiration device as in claim 15 , further comprising a heat source in the control unit.
25. A nipple aspirate fluid aspiration device as in claim 15 , further comprising a central processing unit for controlling the inflatable bladders.
26. A nipple aspirate fluid aspiration device as in claim 1 , further comprising a disposable patient interface carried by the adjustable support, for contacting the patient.
27. A nipple aspirate fluid aspiration device as in claim 26 , wherein the disposable patient interface comprises a flexible polymeric membrane.
28. A nipple aspirate fluid aspiration device as in claim 27 , wherein the disposable patient interface further comprises a rigid support for maintaining patency under vacuum, attached to the flexible polymeric membrane.
29. A nipple aspirate fluid aspiration device as in claim 28 , wherein the rigid support comprises at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
30. A nipple aspirate fluid aspiration device as in claim 29 , wherein the first retention structure comprises a recess on the rigid support.
31. A nipple aspirate fluid aspiration device as in claim 29 , wherein the first retention structure comprises a projection on the rigid support.
32. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use, the supports moveable throughout an adjustment range;
a moveable wall positioned in between the supports and the patient when in use;
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use; and
a control, for controlling the adjustment.
33. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 32 , wherein the control comprises a rotatable ring.
34. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 32 , wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
35. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 34 , wherein the first diameter is within the range of from about 2.5 inches to about 4.5 inches.
36. A device for obtaining an intraductal fluid sample from a non lactating breast an in claim 34 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
37. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 32 , wherein the movable wall comprises a wall on an inflatable bladder.
38. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 37 , further comprising an inflatable bladder carried by each of the supports.
39. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 32 , wherein the disposable patient interface comprises a flexible membrane.
40. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 39 , wherein the flexible membrane comprises a tubular body having a proximal end with a first diameter and a distal end with a second, larger diameter.
41. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 40 , further comprising a releasable connector on the proximal end.
42. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 39 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
43. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 32 , further comprising a heat source in thermal communication with the movable wall.
44. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use;
a moveable wall positioned in between the support and the patient when in use; and
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use, the patient interface comprising a flexible membrane having a tubular body with a proximal end having a first diameter and a second end having a second, larger diameter, and a releasable connector on the proximal end;
wherein the movable wall comprises a wall on an inflatable bladder.
45. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 44 , wherein the supports are moveable throughout an adjustment range.
46. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 45 , further comprising a control, for controlling the adjustment.
47. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 46 , wherein the control comprises a rotatable ring.
48. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 45 , wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
49. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 48 , wherein the first diameter as within the range of from about 2.5 inches to about 4.5 inches.
50. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 48 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
51. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 44 , comprising an inflatable bladder carried by each of the supports.
52. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 44 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
53. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least one inflatable bladder within the concavity;
a vacuum source in communication with the concavity; and
a control for inflating and deflating the bladder in accordance with a predetermined program;
wherein the predetermined program comprises alternating inflation and deflation cycles;
wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
54. A nipple aspirate fluid aspiration device as in claim 53 , wherein each petal carries an inflatable bladder.
55. A nipple aspirate fluid aspiration device as in claim 53 wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
56. A nipple aspirate fluid aspiration device as in claim 53 , wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
57. A nipple aspirate fluid aspiration device as in claim 53 , further comprising a central processing unit for controlling the inflatable bladder.
58. A nipple aspirate fluid aspiration device as in claim 53 , wherein the bladder has an inflated thickness of no more than about 1 inch.
59. A nipple aspirate fluid aspiration device as in claim 58 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
60. A nipple aspirate fluid aspiration device as in claim 53 , further comprising a heat source.
61. A nipple aspirate fluid aspiration device as in claim 60 , wherein the heat source is in thermally conductive contact with the bladder.
62. A nipple aspirate fluid aspiration device as in claim 60 , further comprising a fluid circulation pathway for circulating a fluid through the bladder.
63. A nipple aspirate fluid aspiration device as in claim 62 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid heats the bladder.
64. A nipple aspirate fluid aspiration device as in claim 62 , further comprising at least three inflatable bladders, in fluid communication with the circulation pathway.
65. A nipple aspirate fluid aspiration device as in claim 60 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
66. A nipple aspirate fluid aspiration device as in claim 53 , further comprising:
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
67. A nipple aspirate fluid aspiration device as in claim 66 , further comprising a central processing unit for controlling the inflatable bladder.
68. A nipple aspirate fluid aspiration device as in claim 66 , further comprising a heat source in the control unit.
69. A nipple aspirate fluid aspiration device as in claim 66 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
70. A nipple aspirate fluid aspiration device as in claim 69 , wherein the bladder comprises at least 3 inflatable lobes.
71. A nipple aspirate fluid aspiration device as in claim 70 , comprising at least 6 inflatable lobes.
72. A nipple aspirate fluid aspiration device as in claim 70 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
73. A nipple aspirate fluid aspiration device as in claim 72 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
74. A nipple aspirate fluid aspiration device as in claim 69 , further comprising a heat exchange fluid contained within the closed loop.
75. A nipple aspirate fluid aspiration device as in claim 69 , further comprising a pump in the control unit.
76. A nipple aspirate fluid aspiration device as in claim 75 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
77. A nipple aspirate fluid aspiration device as in claim 53 , further comprising a disposable patient interface carried by the adjustable support, for contacting the patient.
78. A nipple aspirate fluid aspiration device as in claim 77 , wherein the disposable patient interface comprises a flexible polymeric membrane.
79. A nipple aspirate fluid aspiration device as in claim 78 , wherein the disposable patient interface further comprises a rigid support for maintaining patency under vacuum, attached to the flexible polymeric membrane.
80. A nipple aspirate fluid aspiration device as in claim 79 , wherein the rigid support comprises a proximal cap, the proximal cap comprising at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
81. A nipple aspirate fluid aspiration device as in claim 80 , wherein the first retention structure comprises a recess on the proximal cap.
82. A nipple aspirate fluid aspiration device as in claim 80 , wherein the first retention structure comprises a projection on the proximal cap.
83. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least one inflatable bladder within the concavity; and
a vacuum source in communication with the concavity;
wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
84. A nipple aspirate fluid aspiration device as in claim 83 , wherein each petal carries an inflatable bladder.
85. A nipple aspirate fluid aspiration device as in claim 83 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
86. A nipple aspirate fluid aspiration device as in claim 83 , further comprising a central processing unit for controlling the inflatable bladder.
87. A nipple aspirate fluid aspiration device as in claim 83 , further comprising a heat source.
88. A nipple aspirate fluid aspiration device as in claim 87 , wherein the heat source is in thermally conductive contact with the bladder.
89. A nipple aspirate fluid aspiration device as in claim 87 , further comprising a fluid circulation pathway for circulating a fluid through the bladder.
90. A nipple aspirate fluid aspiration device as in claim 89 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid heats the bladder.
91. A nipple aspirate fluid aspiration device as in claim 89 , further comprising at least three inflatable bladders, in fluid communication with the circulation pathway.
92. A nipple aspirate fluid aspiration device as in claim 83 , further comprising a control for inflating and deflating the bladder in accordance with a predetermined program.
93. A nipple aspirate fluid aspiration device as in claim 92 wherein the predetermined program comprises alternating inflation and deflation cycles.
94. A nipple aspirate fluid aspiration device as in claim 93 wherein the predetermined program inflates the bladder within the range of from about 2 to about 40 cycles per minute.
95. A nipple aspirate fluid aspiration device as in claim 94 wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
96. A nipple aspirate fluid aspiration device as in claim 93 wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
97. A nipple aspirate fluid aspiration device as in claim 83 , further comprising:
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
98. A nipple aspirate fluid aspiration device as in claim 97 , further comprising a central processing unit for controlling the inflatable bladder.
99. A nipple aspirate fluid aspiration device as in claim 97 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
100. A nipple aspirate fluid aspiration device as in claim 99 , wherein the bladder comprises at least 3 inflatable lobes.
101. A nipple aspirate fluid aspiration device as in claim 100 , comprising at least 6 inflatable lobes.
102. A nipple aspirate fluid aspiration device as in claim 100 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
103. A nipple aspirate fluid aspiration device as in claim 102 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
104. A nipple aspirate fluid aspiration device as in claim 99 , further comprising a heat exchange fluid contained within the closed loop.
105. A nipple aspirate fluid aspiration device as in claim 99 , further comprising a pump in the control unit.
106. A nipple aspirate fluid aspiration device as in claim 105 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
107. A nipple aspirate fluid aspiration device as in claim 97 , further comprising a heat source in the control unit.
108. A nipple aspirate fluid aspiration device as in claim 83 , wherein the bladder has an inflated thickness of no more than about 1 inch.
109. A nipple aspirate fluid aspiration device as in claim 108 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
110. A nipple aspirate fluid aspiration device as in claim 83 , further comprising a disposable patient interface carried by the adjustable support, for contacting the patient.
111. A nipple aspirate fluid aspiration device as in claim 110 , wherein the disposable patient interface comprises a flexible polymeric membrane.
112. A nipple aspirate fluid aspiration device as in claim 111 , wherein the disposable patient interface further comprises a rigid support for maintaining patency under vacuum, attached to the flexible polymeric membrane.
113. A nipple aspirate fluid aspiration device as in claim 112 , wherein the rigid support comprises a proximal cap, having at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
114. A nipple aspirate fluid aspiration device as in claim 113 , wherein the first retention structure comprises a recess on the proximal cap.
115. A nipple aspirate fluid aspiration device as in claim 113 , wherein the first retention structure comprises a projection on the proximal cap.
116. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use;
a moveable wall positioned in between the supports and the patient when in use; and
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use;
wherein the supports are moveable throughout an adjustment range; and
wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
117. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , wherein the first diameter is within the range of from about 2.5 inches to about 4.5 inches.
118. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
119. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , further comprising a heat source in thermal communication with the movable wall.
120. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , further comprising a control, for controlling the adjustment.
121. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 120 , wherein the control comprises a rotatable ring.
122. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , wherein the movable wall comprises a wall on an inflatable bladder.
123. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 122 , comprising an inflatable bladder carried by each of the supports.
124. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 116 , wherein the disposable patient interface comprises a flexible membrane.
125. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 124 , wherein the flexible membrane comprises a tubular body having a proximal end with a first diameter and a distal end with a second, larger diameter.
126. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 125 , further comprising a releasable connector on the proximal end.
127. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 124 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
128. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use;
a moveable wall positioned in between the supports and the patient when in use; and
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use;
wherein the movable wall comprises a wall on an inflatable bladder.
129. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 128 , further comprising an inflatable bladder carried by each of the supports.
130. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 128 , further comprising a heat source in thermal communication with the movable wall.
131. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 128 , wherein the supports are moveable throughout an adjustment range.
132. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 131 , further comprising a control, for controlling the adjustment.
133. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 132 , wherein the control comprises a rotatable ring.
134. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 131 , wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
135. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 134 , wherein the first diameter is within the range of from about 2.5 inches to about 4.5 inches.
136. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 134 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
137. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 128 , wherein the disposable patient interface comprises a flexible membrane.
138. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 137 , wherein the flexible membrane comprises a tubular body having a proximal end with a first diameter and a distal end with a second, larger diameter.
139. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 138 , further comprising a releasable connector on the proximal end.
140. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 137 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
141. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use;
a moveable wall positioned in between the supports and the patient when in use; and
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use;
wherein the disposable patient interface comprises a flexible membrane; and
wherein the flexible membrane comprises a tubular body having a proximal end with a first diameter and a distal end with a second, larger diameter.
142. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 141 , further comprising a releasable connector on the proximal end.
143. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 141 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
144. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 141 , further comprising a heat source in thermal communication with the movable wall.
145. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 141 , wherein the movable wall comprises a wall on an inflatable bladder.
146. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 145 , further comprising an inflatable bladder carried by each of the supports.
147. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 141 , wherein the supports are moveable throughout an adjustment range.
148. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 147 , further comprising a control, for controlling the adjustment.
149. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 148 , wherein the control comprises a rotatable ring.
150. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 147 , wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
151. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 150 , wherein the first diameter is within the range of from about 2.5 inches to about 4.5 inches.
152. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 150 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
153. A device for obtaining an intraductal fluid sample from a non lactating breast, comprising:
a frame;
at least three supports on the frame, having first sides for facing in the direction of a patient when in use, the supports moveable throughout an adjustment range;
a moveable wall positioned in between the supports and the patient when in use;
a disposable patient interface positioned between the movable wall and the patient, for contacting the patient when in use, the patient interface comprising a flexible membrane having a tubular body with a proximal end having a first diameter and a second end having a second, larger diameter, and a releasable connector on the proximal end; and
a control, for controlling the adjustment.
154. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 153 , wherein the control comprises a rotatable ring.
155. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 153 , wherein the flexible membrane comprises a low durometer thermoplastic elastomer.
156. A device for obtaining an intraductal fluid sample from a non-lactating breast as in claim 153 , wherein the movable wall comprises a wall on an inflatable bladder.
157. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 156 , comprising an inflatable bladder carried by each of the supports.
158. A device for obtaining an intraductal fluid sample from a non lactating breast an in claim 153 , wherein each support has a proximal end in the direction of the frame, and a distal end in the direction of the patient, and the distal ends form an annular distal limit which is moveable between a first, small diameter and a second, large diameter at the limits of the adjustment range.
159. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 158 , wherein the first diameter is within the range of from about 2.5 inches to about 4.5 inches.
160. A device for obtaining an intraductal fluid sample from a non lactating breast as in claim 158 , wherein the second diameter is within the range of from about 3.5 inches to about 6.5 inches.
161. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least one inflatable bladder within the concavity;
a vacuum source in communication with the concavity;
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
162. A nipple aspirate fluid aspiration device as in claim 161 , wherein each petal carries an inflatable bladder.
163. A nipple aspirate fluid aspiration device as in claim 161 , further comprising a heat source in the control unit.
164. A nipple aspirate fluid aspiration device as in claim 161 , wherein the bladder has an inflated thickness of no more than about 1 inch.
165. A nipple aspirate fluid aspiration device as in claim 164 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
166. A nipple aspirate fluid aspiration device as in claim 161 , further comprising a heat source.
167. A nipple aspirate fluid aspiration device as in claim 166 , wherein the heat source is in thermally conductive contact with the bladder.
168. A nipple aspirate fluid aspiration device as in claim 166 , further comprising a fluid circulation pathway for circulating a fluid through the bladder.
169. A nipple aspirate fluid aspiration device as in claim 168 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid through the bladder.
170. A nipple aspirate fluid aspiration device as in claim 168 , further comprising at least three inflatable bladders, in fluid communication with the circulation pathway.
171. A nipple aspirate fluid aspiration device as in claim 161 , wherein the control unit controls inflating and deflating the bladder in accordance with a predetermined program.
172. A nipple aspirate fluid aspiration device as in claim 171 , wherein the predetermined program comprises alternating inflation and deflation cycles.
173. A nipple aspirate fluid aspiration device as in claim 172 , wherein the predetermined program inflates the bladder within the range of from about 2 to about 40 cycles per minute.
174. A nipple aspirate fluid aspiration device as in claim 173 , wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
175. A nipple aspirate fluid aspiration device as in claim 172 , wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
176. A nipple aspirate fluid aspiration device as in claim 161 , wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
177. A nipple aspirate fluid aspiration device as in claim 176 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
178. A nipple aspirate fluid aspiration device as in claim 161 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
179. A nipple aspirate fluid aspiration device as in claim 178 , further comprising a pump in the control unit.
180. A nipple aspirate fluid aspiration device as in claim 179 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
181. A nipple aspirate fluid aspiration device as in claim 178 , wherein the bladder comprises at least 3 inflatable lobes.
182. A nipple aspirate fluid aspiration device as in claim 181 , comprising at least 6 inflatable lobes.
183. A nipple aspirate fluid aspiration device as in claim 178 , further comprising a heat exchange fluid contained within the closed loop.
184. A nipple aspirate fluid aspiration device as in claim 181 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
185. A nipple aspirate fluid aspiration device as in claim 184 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
186. A nipple aspirate fluid aspiration device as in claim 178 , further comprising a central processing unit for controlling the inflatable bladder.
187. A nipple aspirate fluid aspiration device as in claim 178 , further comprising a central processing unit for controlling the inflatable bladder.
188. A nipple aspirate fluid aspiration device as in claim 161 , further comprising a disposable patient interface carried by the adjustable support, for contacting the patient.
189. A nipple aspirate fluid aspiration device as in claim 188 , wherein the disposable patient interface comprises a flexible polymeric membrane.
190. A nipple aspirate fluid aspiration device as in claim 189 , wherein the disposable patient interface further comprises a rigid support for maintaining patency under vacuum, attached to the flexible polymeric membrane.
191. A nipple aspirate fluid aspiration device as in claim 190 , wherein the rigid support comprises a proximal cap, wherein the proximal cap comprises at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
192. A nipple aspirate fluid aspiration device as in claim 191 , wherein the first retention structure comprises a recess on the proximal cap.
193. A nipple aspirate fluid aspiration device as in claim 191 , wherein the first retention structure comprises a projection on the proximal cap.
194. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least one inflatable bladder within the concavity;
a vacuum source in communication with the concavity; and
a disposable patient interface carried by the adjustable support, for contacting the patient;
wherein the disposable patient interface comprises a flexible polymeric membrane.
195. A nipple aspirate fluid aspiration device as in claim 194 , further comprising a central processing unit for controlling the inflatable bladder.
196. A nipple aspirate fluid aspiration device as in claim 194 , wherein each petal carries an inflatable bladder.
197. A nipple aspirate fluid aspiration device as in claim 194 , wherein the disposable patient interface further comprises a rigid support for maintaining patency under vacuum, attached to the flexible polymeric membrane.
198. A nipple aspirate fluid aspiration device as in claim 194 , wherein the bladder has an inflated thickness of no more than about 1 inch.
199. A nipple aspirate fluid aspiration device as in claim 198 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
200. A nipple aspirate fluid aspiration device as in claim 194 , further comprising a proximal cap on the disposable patient interface, wherein the proximal cap comprises at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
201. A nipple aspirate fluid aspiration device as in claim 200 , wherein the first retention structure comprises a recess on the proximal cap.
202. A nipple aspirate fluid aspiration device as in claim 200 , wherein the first retention structure comprises a projection on the proximal cap.
203. A nipple aspirate fluid aspiration device as in claim 194 , further comprising a heat source.
204. A nipple aspirate fluid aspiration device as in claim 203 , wherein the heat source is in thermally conductive contact with the bladder.
205. A nipple aspirate fluid aspiration device as in claim 203 , further comprising a fluid circulation pathway for circulating a fluid through the bladder.
206. A nipple aspirate fluid aspiration device as in claim 205 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid heats the bladder.
207. A nipple aspirate fluid aspiration device as in claim 205 , further comprising at least three inflatable bladders, in fluid communication with the circulation pathway.
208. A nipple aspirate fluid aspiration device as in claim 194 , further comprising a control for inflating and deflating the bladder in accordance with a predetermined program.
209. A nipple aspirate fluid aspiration device as in claim 208 , wherein the predetermined program comprises alternating inflation and deflation cycles.
210. A nipple aspirate fluid aspiration device as in claim 209 , wherein the predetermined program inflates the bladder within the range of from about 2 to about 40 cycles per minute.
211. A nipple aspirate fluid aspiration device as in claim 210 , wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
212. A nipple aspirate fluid aspiration device as in claim 209 , wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
213. A nipple aspirate fluid aspiration device as in claim 194 , wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
214. A nipple aspirate fluid aspiration device as in claim 213 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
215. A nipple aspirate fluid aspiration device as in claim 194 , further comprising:
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
216. A nipple aspirate fluid aspiration device as in claim 215 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
217. A nipple aspirate fluid aspiration device as in claim 216 , further comprising a pump in the control unit.
218. A nipple aspirate fluid aspiration device as in claim 217 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
219. A nipple aspirate fluid aspiration device as in claim 216 , wherein the bladder comprises at least 3 inflatable lobes.
220. A nipple aspirate fluid aspiration device as in claim 219 , comprising at least 6 inflatable lobes.
221. A nipple aspirate fluid aspiration device as in claim 216 , further comprising a heat exchange fluid contained within the closed loop.
222. A nipple aspirate fluid aspiration device as in claim 219 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
223. A nipple aspirate fluid aspiration device as in claim 222 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
224. A nipple aspirate fluid aspiration device as in claim 215 , further comprising a heat source in the control unit.
225. A nipple aspirate fluid aspiration device as in claim 215 , further comprising a central processing unit for controlling the inflatable bladder.
226. A nipple aspirate fluid aspiration device, comprising:
an adjustable support, defining a concavity, the support comprising a plurality of petals, movable throughout an adjustment range;
at least one inflatable bladder within the concavity;
a vacuum source in communication with the concavity; and
a disposable patient interface having a proximal cap, wherein the proximal cap comprises at least a first retention structure for releasable connection with a complementary second retention structure on a handpiece.
227. A nipple aspirate fluid aspiration device as in claim 226 , wherein each petal carries an inflatable bladder.
228. A nipple aspirate fluid aspiration device as in claim 226 , wherein the bladder is inflatable from a reduced profile along an axis transverse to the support and an inflated profile along the axis.
229. A nipple aspirate fluid aspiration device as in claim 228 , wherein the bladder has a maximum thickness in the inflated profile along the axis within the range of from about 0.2 inches to about 2.0 inches.
230. A nipple aspirate fluid aspiration device as in claim 226 , further comprising a heat source.
231. A nipple aspirate fluid aspiration device as in claim 230 , wherein the heat source is in thermally conductive contact with the bladder.
232. A nipple aspirate fluid aspiration device as in claim 230 , further comprising a fluid circulation pathway for circulating a fluid through the bladder.
233. A nipple aspirate fluid aspiration device as in claim 232 , wherein the heat source is in thermally conductive contact with the fluid so that the fluid heats the bladder.
234. A nipple aspirate fluid aspiration device as in claim 232 , further comprising at least three inflatable bladders, in fluid communication with the circulation pathway.
235. A nipple aspirate fluid aspiration device as in claim 226 , further comprising a control for inflating and deflating the bladder in accordance with a predetermined program.
236. A nipple aspirate fluid aspiration device as in claim 235 , wherein the predetermined program comprises alternating inflation and deflation cycles.
237. A nipple aspirate fluid aspiration device as in claim 236 , wherein the predetermined program inflates the bladder within the range of from about 2 to about 40 cycles per minute.
238. A nipple aspirate fluid aspiration device as in claim 237 , wherein the predetermined program inflates the bladder within the range of from about 3 to about 12 cycles per minute.
239. A nipple aspirate fluid aspiration device as in claim 236 , wherein the predetermined program maintains the bladder inflated within the range of from about 4 to about 8 seconds per cycle.
240. A nipple aspirate fluid aspiration device as in claim 226 , further comprising:
a control unit;
a patient interface unit, carrying the adjustable support; and
a control line extending between the control unit and the patient interface unit.
241. A nipple aspirate fluid aspiration device as in claim 240 , further comprising a central processing unit for controlling the inflatable bladder.
242. A nipple aspirate fluid aspiration device as in claim 240 , further comprising a heat source in the control unit.
243. A nipple aspirate fluid aspiration device as in claim 240 , further comprising a closed fluid circulation loop, having a reservoir removably carried by the control unit in communication with the bladder carried by the patient interface unit.
244. A nipple aspirate fluid aspiration device as in claim 243 , further comprising a pump in the control unit.
245. A nipple aspirate fluid aspiration device as in claim 244 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.
246. A nipple aspirate fluid aspiration device as in claim 243 , further comprising a heat exchange fluid contained within the closed loop.
247. A nipple aspirate fluid aspiration device as in claim 243 , wherein the bladder comprises at least 3 inflatable lobes.
248. A nipple aspirate fluid aspiration device as in claim 247 , comprising at least 6 inflatable lobes.
249. A nipple aspirate fluid aspiration device as in claim 247 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.
250. A nipple aspirate fluid aspiration device as in claim 249 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.
251. A nipple aspirate fluid aspiration device as in claim 226 , wherein the bladder has an inflated thickness of no more than about 1 inch.
252. A nipple aspirate fluid aspiration device as in claim 251 , wherein the bladder has an inflated thickness of no more than about 0.5 inches.
253. A nipple aspirate fluid aspiration device as in claim 226 , wherein the disposable patient interface is carried by the adjustable support, for contacting the patient.
254. A nipple aspirate fluid aspiration device as in claim 253 , wherein the disposable patient interface comprises a flexible polymeric membrane.
255. A nipple aspirate fluid aspiration device as in claim 226 , wherein the first retention structure comprises a recess on the proximal cap.
256. A nipple aspirate fluid aspiration device as in claim 226 , wherein the first retention structure comprises a projection on the proximal cap.
257. A nipple aspirate fluid aspiration device as in claim 226 , further comprising a central processing unit for controlling the inflatable bladder.