Medical instrument for accessing a breast duct for performing a medical procedure
First Claim
1. An device for being introduced and positioned within a breast duct for introducing or removing material within the breast duct, said apparatus comprising:
- a manifold hub comprising a plurality of port openings in fluid communication with an interior of said manifold hub, at least two of said openings being in fluid communication with a pair of elongated channels that extend through a portion of said manifold hub;
a catheter extending from the manifold hub, said catheter being sized and configured for positioning within a breast duct; and
a retractable spacer that may be moved in a direction parallel to the length of the catheter to space the manifold hub a distance above the surface of a nipple.
8 Assignments
0 Petitions
Accused Products
Abstract
A medical instrument including a ductal access device comprising a low profile, ergonomic manifold hub usable to introduce fluids into a breast duct and collect ductal fluid samples including ductal epithelial cells and clumps of ductal epithelial cells from within a breast duct. The ductal access device also comprises an elongated access catheter having a distal end, one lumen and dimensions which permit introduction of the distal end through a ductal orifice so that a distal end of the catheter may be positioned distal to the ductal sphincter of a human breast. The medical instrument may also include at least one spacing member for adjustably positioning the manifold hub a desired distance above the surface of the nipple. The spacing member may control the insertion depth of the catheter into the duct. The medical instrument may also include at least one member for anchoring the device to the breast.
51 Citations
60 Claims
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1. An device for being introduced and positioned within a breast duct for introducing or removing material within the breast duct, said apparatus comprising:
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a manifold hub comprising a plurality of port openings in fluid communication with an interior of said manifold hub, at least two of said openings being in fluid communication with a pair of elongated channels that extend through a portion of said manifold hub;
a catheter extending from the manifold hub, said catheter being sized and configured for positioning within a breast duct; and
a retractable spacer that may be moved in a direction parallel to the length of the catheter to space the manifold hub a distance above the surface of a nipple. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A medical device for introducing a fluid into a breast duct, said device comprising:
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a catheter sized and configured to extend within a breast duct, said catheter having an internal lumen extending substantially parallel to a longitudinal axis of said catheter;
a manifold hub connected to and in fluid communication with said catheter, said manifold hub including at least four ports in fluid communication within an interior of said manifold hub, at least two of said at least four ports being in fluid communication with channels formed within said manifold hub for receiving a fluid introduction line and a ductal fluid collection line, respectively, said manifold hub having a height extending parallel the longitudinal axis of said catheter and a length extending perpendicular to the longitudinal axis of said catheter, said length of said manifold hub being greater than said height of said manifold hub. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. A ductal access device for aspirating fluid from a breast duct, said device comprising:
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a manifold hub for receiving a fluid to be introduced into a breast duct;
a catheter extending from said manifold hub, said catheter being sized for positioning within a breast duct and including a lumen for introducing and receiving fluid within the breast duct, said lumen being in fluid communication with said manifold hub and sized to receive a ductal fluid sample from within the breast duct; and
a source of negative pressure in fluid communication with said manifold hub such that ductal fluid samples within the manifold hub are drawn to said source of negative pressure for being received within a collection device. - View Dependent Claims (47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)
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Specification