U.S. patent application number 11/415029 was filed with the patent office on 2006-08-31 for ductal lavage microcatheter with user activated valve and nitinol introducer.
Invention is credited to Meghan Brennan, Simon Furnish, Todd A. Hall, Douglas Macarthur, Ben E. Morris, Robert Sakal.
Application Number | 20060195065 11/415029 |
Document ID | / |
Family ID | 34679213 |
Filed Date | 2006-08-31 |
United States Patent
Application |
20060195065 |
Kind Code |
A1 |
Sakal; Robert ; et
al. |
August 31, 2006 |
Ductal lavage microcatheter with user activated valve and nitinol
introducer
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 and activate valve and a
Nitinol introducer.
Inventors: |
Sakal; Robert; (Bolton,
MA) ; Brennan; Meghan; (Newburyport, MA) ;
Macarthur; Douglas; (Acton, MA) ; Morris; Ben E.;
(Louisville, KY) ; Hall; Todd A.; (Goshen, KY)
; Furnish; Simon; (New York, NY) |
Correspondence
Address: |
Theodore Allen, Esq.;Cytyc Corporation
85 Swanson Road
Boxborough
MA
01719
US
|
Family ID: |
34679213 |
Appl. No.: |
11/415029 |
Filed: |
May 1, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10746117 |
Dec 23, 2003 |
|
|
|
11415029 |
May 1, 2006 |
|
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|
Current U.S.
Class: |
604/167.04 ;
251/7; 600/573 |
Current CPC
Class: |
A61M 2210/1007 20130101;
A61B 10/0045 20130101; A61M 25/01 20130101; A61B 10/0041 20130101;
A61M 39/06 20130101; A61M 2025/0042 20130101; A61M 25/0102
20130101 |
Class at
Publication: |
604/167.04 ;
600/573; 251/007 |
International
Class: |
A61M 5/178 20060101
A61M005/178; A61B 5/00 20060101 A61B005/00; B65D 81/00 20060101
B65D081/00; F16K 7/04 20060101 F16K007/04 |
Claims
1. A 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 fitting for
sealing about a ductal introducer extending through said manifold
hub at one end of said manifold hub said fitting including an
aperture that may be repeatedly opened and closed, the sides of
said manifold hub comprising two opposing flexible arms connected
at one end to the base of said hub and unconnected at the other end
and substantially parallel to one another, said arms are held in a
sprung position such that said unconnected ends of said arms
compress said fitting such that said aperture is closed and when
said arms are compressed, said unconnected ends of said arms no
longer compress said fitting and said aperture is opened.
2. The device of claim 1 wherein said sealing fitting is a silicone
gasket.
3. The device of claim 1 wherein springs are located between said
flexible arms and the body of said hub such that the springs keep
said arms in actuated position.
4. The device of claim 1 wherein the free ends of said arms are
interlocking hooks.
5. The device of claim 1 wherein said ductal introducer has a ring
shaped handle.
6. The device of claim 1 wherein said ductal introducer is made of
Nitinol and has a distal tip that tapers.
7. The device of claim 1 wherein said introducer tapers from
approximately 0.025 inches to approximately 0.008 inches.
8. A method for obtaining cellular material from a human breast
milk duct using a device comprising a manifold hub comprising a
fitting for sealing about a ductal introducer extending through
said manifold hub at one end of said manifold hub said fitting
including an aperture that may be repeatedly opened and closed, the
sides of said manifold hub comprising two opposing flexible arms
connected at one end to the base of said hub and unconnected at the
other end and substantially parallel to one another, said arms are
held in a sprung position such that said unconnected ends of said
arms compress said fitting such that said aperture is closed and
when said arms are compressed, said unconnected ends of said arms
no longer compress said fitting and said aperture is opened; and
including the steps of: inserting the introducer into the internal
passageway of a breast duct; and advancing the catheter into the
breast duct.
9. A method for obtaining cellular material from a human breast
milk duct using a device comprising a manifold hub comprising a
fitting for sealing about a ductal introducer extending through
said manifold hub at one end of said manifold hub said fitting
including an aperture that may be repeatedly opened and closed, the
sides of said manifold hub comprising two opposing flexible arms
connected at one end to the base of said hub and unconnected at the
other end and substantially parallel to one another, said arms are
held in a sprung position such that said unconnected ends of said
arms compress said fitting such that said aperture is closed and
when said arms are compressed, said unconnected ends of said arms
no longer compress said fitting and said aperture is opened; and
including the steps of: inserting the introducer into the internal
passageway of a breast duct; advancing the sheath into the breast
duct; and advancing the catheter into the breast duct.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a medical instrument having
at least a portion that is introduced into the body of a mammal in
order to perform diagnostic or therapeutic medical procedures, more
specifically, the present invention relates to a medical instrument
useable during a diagnostic or therapeutic medical procedure that
is sized for introducing into a breast duct through a ductal
orifice.
BACKGROUND OF THE INVENTION
[0002] The breast is a specialized, glandular structure including a
system of complicated breast ducts that radiate from the nipple and
that are bound together by fairly dense connective tissue. Each of
these breast ducts includes an associated ductal orifice on the
surface of a nipple through which ductal fluid may be expressed.
Each duct includes a series of successive interlobular branches
that drain through the main, lactiferous branch, which terminates
and exits the breast at the nipple via the associated ductal
orifice. Immediately proximate the ductal orifice, each lactiferous
duct includes a lactiferous sinus in which ductal fluid may
accumulate. A ductal sphincter resides within the lactiferous sinus
and prevents ductal fluid from unintentionally exiting the breast
duct through its associated ductal orifice.
[0003] Breast cancer is believed to begin in the lining of these
breast ducts. For several decades significant members of the
medical community dedicated to studying breast cancer have believed
and shown that the cytological analysis of cells retrieved from
nipple discharge fluid from within breast ducts may provide
valuable information leading to identifying patients at risk for
breast cancer. Indeed, Papanicolaou contributed to the genesis of
such a possibility of a "Pap" smear for breast cancer by analyzing
the cells contained in nipple discharge. More recently, cancer
specific markers have been detected in ductal fluid obtained by
nipple aspiration. However, the retrieval techniques and
instruments used by these members of the medical community did not
routinely obtain meaningful ductal fluid samples.
[0004] In their attempts to retrieve the breast duct fluid sample
including ductal epithelial cells, practitioners introduced wash
fluids into a breast duct using indwelling hair-like single lumen
catheters. After the fluid was introduced into the duct, the fluid
introduction catheters were removed. Then, externally applied
nipple aspiration techniques or external pressure applied to the
breast were used to collect samples of the ductal fluid. However,
these techniques required that significant, sometimes painful,
pressure be created on the nipple surface or along the sides of the
breast to overcome the fluid retaining properties of the ductal
sphincter. Also, these techniques did not routinely provide
meaningful ductal fluid samples with a sufficient number of ductal
epithelial cells for a meaningful cellular analysis. These
techniques typically caused the recovery of samples with twenty or
fewer ductal epithelial cells. Additionally, these techniques did
not provide samples with cell clusters of 10 or more cells. As a
result, the obtained fluid samples could not consistently provide
an accurate indication of whether or not the duct from which they
were retrieved included precancerous or cancerous cells.
Consistent, meaningful ductal epithelial cell samples have been
provided by the medical instrument disclosed in U.S. Pat. No.
6,413,228 to Hung et al. that is hereby incorporated by reference
in its entirety.
[0005] Other medical instruments, such as those used during
galactography, are introduced into the breast duct in order to
visually determine the presence of cancerous cells within a breast
duct. However, these devices typically extend a significant
distance out of the breast duct during the performed procedure.
These distances may be twelve inches or greater. As a result, when
an operator is not holding the tool, the moment created by the
weight and length of the section of the instrument extending out of
the duct may cause the indwelling portion of the instrument to
engage the sidewalls of the duct, torque and/or kink the duct and
distort the nipple. These effects on the duct and nipple may impede
the procedure by twisting or crimping the indwelling portion of the
instrument, possibly injuring the patient's duct and causing
significant discomfort to the patient. As a result, a patient must
either endure the pain and discomfort caused by these long
instruments or an attendant must constantly support the instrument
above the patient during the medical procedure.
[0006] However, in the confined space around an operating table and
in the area surrounding a nipple surface, it is not practical to
have an attendant constantly holding the end of the instrument that
is extending into the breast duct. Therefore, prior to receiving
the procedure, a patient must decide to either experience
discomfort during the procedure or choose not to have the procedure
performed. Prior art instruments are also not ergonomically
designed for easy grasping and adjusting by a practitioner or
attendant while acting in the area surrounding a nipple.
SUMMARY OF THE INVENTION
[0007] In accordance with one aspect of the present invention, a
device for being introduced and positioned within a breast duct for
introducing or removing material within the breast duct is
provided. The apparatus comprises a manifold hub comprising a
sealing fitting for sealing about a ductal introducer extending
through the manifold hub at one end of the manifold hub the sealing
fitting including an aperture that may be repeatedly opened and
closed, the sides of the manifold hub comprising two opposing
flexible arms connected at one end to the base of the hub and
unconnected at the other end and substantially parallel to one
another, the arms are held in a sprung position such that the
unconnected ends of said arms compress the sealing fitting such
that the aperture is closed and when the arms are compressed, the
unconnected ends of the arms no longer compress the sealing fitting
and the aperture is opened. The sealing fitting may be comprised of
a silicone gasket. The apparatus may also include springs that are
located between said flexible arms and the body of said hub such
that the springs keep said arms in actuated position. The free ends
of the arms may be interlocking hooks. The ductal introducer may be
a ring shaped handle. The ductal introducer may be made of a
flexible material such as Nitinol and may have a distal tip that
tapers from approximately 0.025 inches to approximately 0.008
inches.
[0008] In yet another aspect of the present invention, a method for
obtaining cellular material from a human breast milk duct is
provided. The method may include using a device comprising a
manifold hub comprising a fitting for sealing about a ductal
introducer extending through said manifold hub at one end of said
manifold hub said fitting including an aperture that may be
repeatedly opened and closed, the sides of said manifold hub
comprising two opposing flexible arms connected at one end to the
base of said hub and unconnected at the other end and substantially
parallel to one another, said arms are held in a sprung position
such that said unconnected ends of said arms compress said fitting
such that said aperture is closed and when said arms are
compressed, said unconnected ends of said arms no longer compress
said fitting and said aperture is opened; and including the steps
of inserting the introducer into the internal passageway of a
breast duct; and advancing the catheter into the breast duct.
[0009] In still yet another aspect of the present invention, a
method for obtaining cellular material from a human breast milk
duct is provided. The method may include using a device comprising
a manifold hub comprising a fitting for sealing about a ductal
introducer extending through said manifold hub at one end of said
manifold hub said fitting including an aperture that may be
repeatedly opened and closed, the sides of said manifold hub
comprising two opposing flexible arms connected at one end to the
base of said hub and unconnected at the other end and substantially
parallel to one another, said arms are held in a sprung position
such that said unconnected ends of said arms compress said fitting
such that said aperture is closed and when said arms are
compressed, said unconnected ends of said arms no longer compress
said fitting and said aperture is opened; and including the steps
of inserting the introducer into the internal passageway of a
breast duct advancing a sheath into the breast duct; and advancing
the catheter into the breast duct.
BRIEF DESCRIPTION OF THE FIGURES
[0010] FIG. 1 is a perspective view of a medical instrument
according to aspects of the present invention;
[0011] FIGS. 2A and 2B are cross sections of alternative
embodiments of the medical instrument illustrated in FIG. 1;
[0012] FIG. 3 is an exploded perspective view of the medical
instrument of FIG. 1;
[0013] FIG. 4 is a top view of the medical instrument of FIG. 1
with infusion and collection lines extending between a manifold hub
and respective infusion and collection devices;
[0014] FIG. 5 is a side view of the medical instrument illustrated
in FIG. 1 carrying infusion and collection lines;
[0015] FIG. 6 is another perspective view of the medical instrument
illustrated in FIG. 1;
[0016] FIGS. 7 and 8 illustrate an alternative embodiment of the
medical instrument according to aspects of the present
invention;
[0017] FIGS. 9-11 illustrate a method for introducing the medical
instrument of FIG. 1 into a breast duct using a stiff introducer;
and
[0018] FIGS. 12-13 illustrate an alternative method for introducing
the medical instrument of FIG. 1 into a breast duct using a
flexible introducer.
[0019] FIGS. 14-17 illustrate an alternative embodiment of the
medical instrument according to aspects of the present invention
including a ductal lavage microcatheter with user activated valve
and Nitinol introducer with a ring shaped handle.
DETAILED DESCRIPTION OF THE INVENTION
[0020] FIG. 1 illustrates an embodiment of a low profile, single
lumen medical instrument 10 for performing a medical procedure
within a breast duct. As used herein, the phrase "medical
procedure" may include preparatory procedures, diagnostic
procedures or therapeutic procedures. These procedures could
include the steps of delivering material(s) into the breast duct
and/or retrieving material(s) from within the breast duct.
[0021] In an embodiment, the medical instrument 10 may be used to
infuse ductal wash fluid delivered to the manifold hub 20 into the
breast duct, and collect or draw up ductal fluid samples, including
hundreds of ductal epithelial cells and/or cell clusters of greater
than ten cells, from within the breast duct for analysis. In
another embodiment, the medical instrument 10 may be used to infuse
a diagnostic agent or therapeutic agent into a breast duct. As
shown in FIGS. 1-8, the instrument 10 may also include a member 11
for securing the instrument 10 to a patient. The securing member 11
may have a biocompatible adhesive on one side for contacting and
attaching the instrument 10 to the patient. The member 11 is sized
to prevent movement of the manifold hub 20 relative to the body of
the patient. In an embodiment illustrated in FIGS. 7 and 8,
sections 11A and 11B of the member 11 may be folded onto each other
so that the size of the securing member 11 may be adjusted to the
patient and the forces created during the procedure. Additionally,
the member 11 may be positioned distal a spacer 90 (discussed
below).
[0022] As illustrated in FIGS. 1-6, the medical instrument 10
includes a manifold hub 20 and a ductal access catheter 40 that
extends from a distal end 21 of the manifold hub 20. The access
catheter 40 is sized to accesses the breast duct. As illustrated,
the manifold hub 20 may have a low profile (height) in a direction
that extends parallel to the length of the catheter 40. As
illustrated in FIGS. 1-6, the height of the manifold hub 20 may be
less than its length (the direction it extends perpendicular to the
length of the catheter 40). In a first embodiment, the manifold hub
20 may have a width in a range from about 0.25 inch to about 0.375
inch and a height in a range from about 0.75 inch to about 1.0
inch. In another embodiment, the manifold hub 20 has an internal
fluid capacity of 1 ml or less. The low profile of the manifold hub
20 will help to prevent a pivot point from being formed at a
location along the length of the catheter 40 at which a large
torque may be applied to the duct of a patient during a medical
procedure. By eliminating or, at least, significantly reducing any
torquing of the duct, the duct will not be kinked, closed due to a
change in the position of ductal tissue or injured due to the
catheter 40 pushing against the epithelial lining of the duct. The
instrument 10 also has an ergonomic design that allows easily
handling and grasping by an attendant or practitioner so that the
manifold hub 20 and catheter 40 may be easily manipulated.
[0023] In the event that the manifold hub 20 needs to be spaced
from the nipple surface, a retractable spacer 90 may be positioned
on the distal end of the manifold hub and at the proximal end of
the catheter 40 as shown in FIGS. 7 and 8. The retractable spacer
90 may have a spacing distance in the range from about 1 mm to
about 10 mm, most typically in the range of about 5 mm. In a first
embodiment, the retractable spacer 90 may include a first spacing
member 92 received within a second spacing member 93.
Alternatively, the first spacing member 92 may telescopically
receive the second spacing member 93. In this embodiment, the first
member 92 is secured against movement relative to the manifold hub
20, while the second member 93 is moveable relative to both the
first member 92 and the manifold hub 20. In an alternative
embodiment, both of the spacing members 92, 93 are moveable
relative to the manifold hub 20. The distances required for spacing
the manifold hub 20 from the surface of the nipple, for example
distances of between about 15 mm and 20 mm, may be controlled by
locking the spacing members 92, 93 in an extended position (FIG.
8). Alternatively, the retractable spacer 90 may be locked in a
retracted position (FIG. 7). In an alternative embodiment, the
retractable spacer 90 includes a single moveable spacing member 95
that slidably receives a portion of the manifold hub 20 to achieve
the retracted position and that may be locked at the end of the
manifold hub 20 to achieve the extended position. In any of the
above-discussed embodiments, the spacing members 92, 93, 95 may be
rotated relative to each other and the manifold hub 20 in order to
lock each spacing member 92, 93 and 95 against translational
movement relative to each other and the manifold hub 20. Any known
rotational locking system for telescoping members may be used.
Alternatively, the spacing members 92, 93, 95 may be snapped into a
locked position using well known snap locks. When additional
spacing is needed, members 92, 93, 95 of different sizes or more
than two telescoping members may be provided.
[0024] The manifold hub 20 may be formed of a transparent material
so that an attendant or practitioner may easily view fluid(s) and
material(s) within the manifold hub 20. The transparent material
may be a plastic, such as ABS plastics or other known plastic
materials. As illustrated in FIGS. 1-8, an embodiment of the
manifold hub 20 may have a substantially "F" shape.
[0025] As shown in FIGS. 2A, 2B and 4, the manifold hub 20 includes
a first port 30 for connecting to an infusion tube 34 through which
materials including wash fluids, diagnostic agents or treatment
agents are delivered from an infusion device 38 to the first port
30, the manifold hub 20 and, eventually, the ductal access catheter
40. The connected infusion device 38 may include a syringe or other
known fluid containers. In an embodiment, the infusion device 38
may include a fluid receptacle, such as a bag or a container,
positioned at a location above the breast of the patient. In this
embodiment, the height of the container above the breast of the
patient and gravity are used to deliver the fluid from the infusion
device 38 to the infusion tube 34.
[0026] As shown in FIGS. 2A, 2B and 4, the manifold hub 20 also
includes a second port 32 for connection to a collection tube 36.
Ductal fluid samples collected from within the breast duct may be
delivered from the manifold hub 20 to a collection receptacle 39
via the collection tube 36. The collection receptacle 39 may
include a syringe or other known fluid collection device including
a medical fluid bag or container. In an embodiment, the collection
receptacle 39 may include or be connected to a source of negative
pressure so that an area of low pressure may be created within the
collection tube 36 and, if needed, the manifold hub 20 for
assisting in the delivery of the retrieved ductal fluid sample to
the collection receptacle 39. The area of low pressure, for example
a vacuum in an embodiment, may be created using a bulb syringe, a
hand-operated vacuum source, a foot operated vacuum source or motor
controlled vacuum source. These vacuum sources may include a pump
that creates negative pressure within the collection tube 36. In
addition to a source of lower pressure, or in place of the source
of lower pressure, low pressure within collection tube 36 may be
created by infusing fluid into the manifold hub 20, thereby
increasing the pressure within the manifold hub 20 relative to the
collection tube 36. In any of these embodiments, the collection
receptacle 39 may be positioned at a location below the patient
during the procedure so that the collected ductal fluid sample may
be delivered to the receptacle 39 by gravity.
[0027] The first and second ports 30, 32 may include an opening
along the sidewall of the manifold hub 20 that is round, oval or
any other geometric shape conducive to fluid flow either into the
duct or out from the duct as shown in FIGS. 2A and 2B. The diameter
of the ports 30, 32 may be that diameter which is suitable to
achieve a desired flow rate into the duct or aspiration or
collection rate out from the duct. Thus, the diameters of the ports
30, 32 may be in a range from about 0.060 inches to about 0.090
inches, One side port 30, 32 may be larger or smaller than the
other, especially where such differential port size provides a
desired flow rate into or out from one of the lumens, or an overall
lavage efficiency of infusion and aspiration or collection of
lavage and ductal fluid.
[0028] FIGS. 1-6 illustrate that the first and second ports 30, 32
and their associated tubes 34, 36, respectively, are positioned
within a connector housing 25 that extends transverse to the
longitudinal axis of the manifold hub 20 and the catheter 40. The
connector housing 25 may be integrally formed with the manifold hub
20 as a unitary element. Alternatively, the connector housing 25
may be formed separate of the manifold hub 20 and secured to the
manifold hub 20 as discussed below with respect to the catheter 40.
The connector housing 25 includes two channels 26 that each
receives one of the tubes 34, 36. The channels 26 extend from the
ports 30, 32 on the manifold hub 20 to the outer, end surface of
the connector housing 25. Each channel 26 aligns the received tube
34, 36 with its respective manifold hub port 30, 32 for easy,
reliable and quick connection of the tubes 34, 36 to their
respective ports 30, 32. The channels 26 also support the tubes 34,
36 at their point of connection to their ports 30, 32 so that the
tubes 34, 36 do not create a moment (that may torque the duct)
about the point where they connect to their respective ports 30,
32. The connector housing 25 may also include contoured sidewalls
28 with integrally formed, or otherwise secured, ridges 29 that may
be gripped by an attendant or a practitioner. The contoured
sidewalls 28 permit easy grasping by the attendant or practitioner
and allow the attendant or practitioner to orient the instrument 10
during a procedure without looking at the instrument 10.
[0029] In an embodiment shown in FIG. 2B, the first and second
ports 30, 32 may include posts 35 that extend within connector
housing 25 and receive the flexible infusion and collection tubes
34, 36. In an embodiment, the infusion and collection tubes 34, 36
may be formed of flexible tubing such as surgical tubing. However,
the tubes 34, 36 may be formed of any flexible material including a
flexible plastic. In one embodiment, the tubes 34, 36 are formed of
flexible PVC.
[0030] The posts 35 may securely receive the tubes 34, 36 when the
tubes 34, 36 are positioned over, or within, the posts 35.
Alternatively, the ports 30, 32 and their associated posts 35 may
include luer lock fittings (not shown) that cooperate with
corresponding luer lock fittings on a first end of the tubes 34,
36. The second end of the tubes 34, 36 may also include luer lock
fittings that mate with standard luer lock fittings on the syringes
or other fluid containers. The luer lock fittings may be either
male or female fittings. As discussed herein, the syringes and
other fluid containers may carry and infuse saline, diagnostic
materials, such as contrast materials, and therapeutic treatment
materials into the infusion tube 34. The tubes 34, 36 may be
secured to the posts 35 of the manifold hub 20 and the luer locks
using a UV curable adhesive or other known bonding agents. In
alternative embodiments, the tubes 34, 36 may be secured to the
manifold hub 20 and the luer locks by overmolding.
[0031] As shown in FIGS. 1-6, the first port 30 may be positioned
adjacent the second port 32 along the perimeter of the manifold hub
20. In the illustrated embodiment, the circumferentially adjacent
ports 30, 32 are spaced the same longitudinal distance from the
first and second ends 22, 24 of the manifold hub 20. This spacing
of the ports 30, 32 provides for a compact and low profile manifold
hub 20 that, as discussed above, will not create a moment and
associated forces that toque the duct when the manifold hub 20 is
positioned on the patient and free of support from a practitioner
or other attendant.
[0032] The second port 32 may be circumferentially spaced any
distance from the first port 30 around the wall of the manifold hub
20. In an embodiment, the first port 30 may be between forty-five
and ninety degrees offset from the second port 32 around the
circumference of the manifold hub 20. In an alternative embodiment,
the first port 30 may be circumferentially offset along the
manifold wall from the second port 32 by between ninety and one
hundred-eighty degrees. In an embodiment, the first port 30 is
circumferentially offset from the second port 32 by about one
hundred-eighty degrees so that the first and second ports 30, 32
oppose each other within the manifold hub 20.
[0033] In an alternative embodiment, it is possible for the second
port 32 to be located along the hub 20 at a position that is spaced
a greater longitudinal distance away from the catheter 40 than the
first port 30. In this embodiment, the second port 32 may be used
to collect the fluid that enters the manifold hub 20 from the
collection catheter 40. For example one port may be located about
2.0 cm from the distal tip of the catheter 40 and one port may be
located about 2.5 cm from the distal tip of the catheter 40.
[0034] The tubes 34 and 36 may each include a one-way check valve
39 (FIG. 2A) to control the fluid flow into and out of the manifold
hub 20. The check valve 39 in the tube 34 may prevent, for example,
wash fluid from flowing back into a syringe connected to tube 34
after being infused into tube 34. Similarly, check valve 39 in tube
36 may be used to prevent retrieved ductal fluid samples in tube 36
from flowing back into the manifold hub 20. In an alternative
embodiment, pinch clamps on the tubes 34, 36, may replace one or
both of the check valves 39. For example, a check valve 39 may be
positioned within the infusion tube 34 and a conventional pinch
clamp may be positioned on the collection tube 36. Other known
devices for controlling the direction and timing of fluid flow
within a tube 34, 36 may also be used.
[0035] As shown in FIGS. 1-6, the catheter 40 includes a thin
walled microcatheter 41 that is secured to the manifold hub 20. In
a first embodiment, the microcatheter 41 is integrally formed as
part of the manifold hub 20. In another embodiment, the
microcatheter 41 is formed as a separate piece and then secured to
the manifold hub 20 by microwelding or a UV curable adhesive. Other
known techniques for securing the microcatheter 41 to the manifold
hub 20 could be used. In any of the above-discussed embodiments,
the catheter 40 may be coated with a known agent to provide a
lubricious coating that allows it to be easily introduced into the
breast duct openings. The coating may include a lubricant, a
cleaning agent, anesthetic and/or a dilating agent. The
microcatheter 41 may be formed of any known biocompatible material
such as FEP. The catheter 40 may have an outer diameter in a range
from about 0.01 inch (about 0.25 mm) to about 0.05 inch (about 1.25
mm) with an inner lumen 43 having a diameter in the range from
about 0.008 inch (about 0.2 mm) to about 0.047 inch (about 1.2 mm).
In an embodiment, the microcatheter 41 has an inner lumen 43 having
an outer diameter of about 0.030 inch (about 0.762 mm) and an inner
diameter of about 0.025 inch (about 0.63 mm).
[0036] The catheter 40 may include length indicia (not shown) on an
outer surface of the catheter 40 that permits a user to determine
the depth to which the distal end of the catheter has been
introduced into the breast duct. In an alternative embodiment, the
catheter 40 could include an integrally formed or attached stop
element (not shown) that prevents insertion of the catheter into
the duct beyond a predetermined distance. In one embodiment, the
stop element may comprise a knob on the catheter 40 having an
increased diameter for preventing the distal portion of the
catheter 40 from entering a duct a greater distance than the knob
is spaced from the distal end of the catheter 40.
[0037] As illustrated in FIGS. 1-7, the catheter 40 may be tapered
along its length to make a smooth transition with a received
introducer 50 so that a perceptible transition between the catheter
40 and the introducer 50 that would cause any pain to the patient
is not formed and felt by the patient. The catheter 40 may also
include an atraumatic distal tip portion 42 at its distal end. The
distal tip portion 42 may be tapered, contoured and/or rounded so
as to produce an atraumatic tip that will reduce or eliminate
trauma to the duct upon entry through the ductal orifice and
introduction into the ductal lumen past the ductal sphincter. The
distal tip portion 42 may also reduce or eliminate trauma upon
withdrawal of the catheter 40 from the duct after the medical
procedure, such as ductal lavage or the infusion of a diagnostic
and/or treatment agent, has been completed. The tip portion 42 may
be composed of a soft polymeric material, e.g. including polyvinyl
chloride, polyethers, polyamides, polyethylenes, polyurethanes,
copolymers thereof and the like. The tip portion 42 may have a
diameter in the range from about 0.012 inches (about 0.031 mm) to
about 0.020 inches (about 0.051 mm). In an embodiment, the tip
portion 42 has a diameter in the range from about 0.014 inches
(about 0.036 mm) to about 0.018 inches (about 0.046 mm). The length
of the tip portion 42 (extending from the distal end of the distal
portion of the catheter 40 toward the proximal end of the catheter
40) may be in a range from about 0.10 inch (about 0.25 cm) to about
1.0 inch (about 2.5 cm), more typically in the range from about
0.20 inch (about 0.50 cm) to about 0.70 inch (about 1.8 cm).
[0038] The stiffened distal portion of the catheter 40, including
the distal tip 42, may have an average bending stiffness in the
range from about 0.010 inch-lbs to about 0.5 inch-lbs. The catheter
40 may also have a stiffness that is similar to that of a heavy
suture (approximately 0.025 OD). The proximal portion of the
catheter 40 may have a cross-sectional geometry and/or size that
inhibits insertion through the ductal orifice and into the ductal
lumen.
[0039] A Touhy-Borst fitting 70 may be positioned at a proximal end
22 of the manifold hub 20 to allow a user to easily receive and
move the catheter 40 over an introducer 50 as shown in FIGS. 1-6.
The Touhy-Borst fitting 70 is positioned at the end of the manifold
hub 20 to cover and seal the opening 77 through which an introducer
50 (discussed-below) including a guidewire, stylet, dilator or the
like may extend. The Touhy-Borst fitting 70 comprises a silicone
plug 72 including a small aperture 74 for receiving the introducer
50, and a threaded cap 76. When the cap 76 is rotated in a first
direction, the silicone plug 72 is altered and the size of the
aperture 74 is reduced. This results in the silicone plug 72
forming a seal around the inserted introducer 50. When the cap 76
is turned in a second, opposite direction, the aperture 74 and
created seal open, thereby allowing the introducer 50 to be
removed. The silicone plug 72 may also be closed to seal the
proximal end of the manifold hub 20 so when the introducer 50 is
not present so that the distal end of the manifold hub 20 is sealed
against fluid flow when the proximal end 22 is free of an
introducer 50.
[0040] The introducer 50 may be located within the manifold hub 20
to assist in placing the catheter 40 into the breast duct and
ductal lumen via the ductal opening as shown in FIG. 1. The
introducer 50 may include a tapered dilator, a series of
progressively larger diameter dilators, a guidewire, including
tapered guidewires, a stylet or other known introducers. As
illustrated, the introducer 50 will pass through the Touhy-Borst
fitting 70 at the proximal end 22 of the manifold hub 20 so that
the introducer 50 may be removed after positioning of the catheter
40 and prior to the infusion/collection of the wash fluid. As
discussed above, prior to being inserted into the breast duct, the
Touhy-Borst fitting 70 may be turned down over the introducer 50
during introduction and then backed off when the catheter 40 has
been positioned within the breast duct to the desired depth. The
introducer 50 may be formed of a stiff material such as a metal
wire or a flexible plastic cord. In an embodiment, the introducer
50 may be formed of stainless steel or a flexible material such as
polypropylene monofilament. In an alternative embodiment, the
introducer 50 may be formed of multiple materials or the same
materials having different stiffnesses. As a result, the introducer
50 may have sections that are more flexible than adjacent sections
of the same introducer 50. As a result, for example, the introducer
50 may have a first, stiff portion for guiding the introducer 50
within the ductal lumen and a second, flexible portion that allows
the introducer 50 to conform to the shape of the ductal lumen or
lumen branch into which it is introduced. In any of the
above-discussed embodiments, the introducer 50 may be coated with a
liquid or dry lubricant material that reduces the friction between
the introducer 50 and the breast duct during the introduction and
advancement of the introducer 50 in the duct.
[0041] The introducer 50 may be made of metal or plastics,
including shape memory metals and plastics, and may have a tapered
and/or an atraumatic tip for gently probing and accessing a breast
duct. Preferably, a tapered tip 52 will extend distally of the
catheter 40 during the introduction of the catheter 40 into the
breast duct. After access of the duct is complete, the introducer
50 may be withdrawn, the Touhy-Borst fitting 70 may be closed and
the indwelling catheter 40 may be positioned at a location distal
to the ductal sphincter. The introducer 50 may have an outer
diameter of from about 0.005 inch to about 0.030 inch. In an
embodiment, the introducer 50 has an outer diameter of about 0.010
inch. The introducer 50 may extend through the manifold hub 20 and
the lumen of the catheter 40. The introducer 50 may be tapered over
its length.
[0042] During the process of introducing the catheter 40 into the
duct, a ductal opening is located on the surface of a nipple by a
practitioner or attendant and a first introducer 50 is advanced
through the ductal opening into the duct. The introducer 50 may be
a long flexible guide wire, a shorter dilator or any of the other
above-mentioned introducers. Prior to, or after the introducer 50
is positioned within the duct, the manifold hub 20 and catheter 40
may receive the first or a second introducer 50. As previously
discussed, the Touhy-Borst fitting 70 may be locked about the
received introducer 50 to form a fluid tight seal at the distal end
of the manifold hub 20 so that fluid does not exit the manifold hub
20 around the introducer 50 during the insertion catheter 40 into
the duct (See FIGS. 9, 10, 12 and 13).
[0043] When the catheter 40 is positioned within the duct as
intended, the Touhy-Borst fitting 70 is opened and the introducer
50 removed (See FIG. 11). The Touhy-Borst 70 may then be closed
again to seal the hub 20. Fluid is then introduced into the
manifold hub 20, through the catheter 40 and into the breast duct
until resistance is met during the infusion. At this time, it is
assumed that the duct is filled. The infusion tube, for example
tube 34, may then be closed and the fluid allowed to remain in the
duct for a preselected time. During this preselected time, the
breast may be massaged and squeezed to stimulate mixing of the wash
fluid and ductal fluid, and also ultimately to encourage the fluid
to leave the duct and enter the manifold hub 20. The collection
tube, for example tube 36, may be opened and the breast squeezed to
urge the fluid to progress through the catheter 40 and into the
manifold hub 20. If desired, when cloudy return fluid is seen in
the hub 20 (which may be transparent or include a transparent
window), the infusion tube 34 may be opened and fluid infused into
the manifold hub 20 to push the ductal fluid sample that has
collected in the hub 20 into the collection tube 36 and a waiting
collection receptacle. Alternatively, and possibly additionally,
aspiration pressure may be applied within the manifold hub 20 and
at the collection tube 36 to aspirate any fluid remaining in the
hub 20 into the collection receptacle. The process is repeated
either following another infusion of fluid into the duct or by
another round of squeezing to encourage return and collection of
the infused fluid and cellular material from within the breast
duct.
[0044] FIGS. 14-17 are schematic diagrams illustrating an
alternative construction of a ductal access device. In a preferred
embodiment of the invention, the device includes a manifold hub 20
and a ductal access catheter 40 that extends from a distal end 21
of the manifold hub 20 with a centrally disposed single lumen which
extends the length of the catheter 40. Catheter 40 includes a
tubular introducer pathway adapted to slideably receive a ductal
introducer 50 therein. For ease of explanation, as used herein the
term "introducer" is defined to include guidewires, dilators,
stylettes or portion of any of these that may be inserted within a
ductal orifice or a passageway of a catheter sized to access a
breast duct.
[0045] As illustrated, the manifold hub 20 may have a low profile
(height) in a direction that extends parallel to the length of the
catheter 40. In another construction, hub 20 has a low profile so
as to reduce the torque on the breast nipple after insertion of
catheter 40. This overcomes the excessive generated torque on the
breast nipple known to cause obstruction of ductal fluid due to
compression of the tissue. Thus, improved collection of ductal
cellular material is provided.
[0046] The manifold hub 20 is coupled to the proximal end 45 of the
ductal access catheter 40. In a preferred construction, hub 20
includes transparent material so that the user may visualize the
flow to and from the breast duct during a lavage procedure. The
transparent material may be plastic, such as ABS plastics or other
known plastic materials. As illustrated in FIGS. 14-17, an
embodiment of the manifold hub 20 may have a substantially "U"
shape.
[0047] A fitting 70 may be positioned at a proximal end 22 of the
manifold hub 20 to allow a user to easily receive and move the
catheter 40 over an introducer 50. The fitting 70 is positioned at
the end of the manifold hub 20 to cover and seal the opening 77
through which an introducer 50 including a guidewire, stylet,
dilator or the like may extend. The fitting 70 comprises a silicone
gasket including a small aperture 74 for receiving the introducer
50, and a cap 76. The cap 76 locks the silicon gasket to the
manifold hub 20 thus maintaining a seal between the hub and the
gasket. The gasket may be made of any suitable flexible
biocompatible material. Around the neck of the silicone gasket are
a pair of interlocking hooks 110 which at the terminus of flexible
side arms 100 which are part of the main body of the manifold hub
20. Located between the flexible side arms and the manifold hub are
one or more springs 120 that force the flexible arms 100 away from
the main body of the manifold hub 20. As the springs 120 force the
flexible side arms 100 away from the manifold hub 20, the
interlocking hooks 110 at the end of the flexible side arms 100
apply pressure to opposite sides of the fitting 70. This results in
the fitting 70, which may be comprised of silicone or any other
flexible material, to compress around the aperture 74 forming a
seal around the inserted introducer 50. When pressure is applied to
the flexible arms 100 thus compressing the springs 120, the
interlocking hooks 110 are actuated apart thus releasing pressure
on the silicon gasket and thus breaking seal around the inserted
introducer 50. The flexible side arms 100 and the interlocking
hooks 110 may be constructed of metal or plastic or a combination
thereof.
[0048] In an alternative embodiment, the manifold hub 20 is
comprised of a single flexible arm 100 with a single hooked end 110
which, when activated, opens or closes the fitting 70.
[0049] The introducer 50 may be located within the manifold hub 20
to assist in placing the catheter 40 into the breast duct and
ductal lumen via the ductal opening as shown in FIGS. 9-13. The
introducer 50 may include a tapered dilator, a series of
progressively larger diameter dilators, a guidewire, including
tapered guidewires, a stylet or other known introducers. As
illustrated, the introducer 50 will pass through the fitting 70 at
the proximal end 22 of the manifold hub 20. The introducer of the
present invention may consist of two parts, a wire and a ring
shaped handle located at the end of the introducer. The introducer
50 has a diameter equal to or slightly less than the ID of the
catheter 40. The length of the introducer 50 may extend
approximately 20-30 mm beyond the distal end of the catheter 40
when the introducer is fully seated. The extended length of the
introducer 50 beyond the distal end of the catheter 40 allows the
introducer to be used as a dilator prior to the insertion of the
catheter in the breast duct. As illustrated in FIG. 18, the distal
end of the introducer 50 may be tapered. The distal tip of the
introducer 50 may be tapered to an OD in the range of 0.008 to
0.010 inches from the proximal end of the introducer that may have
an OD equal to or slightly less than the ID of the distal end of
the catheter 42. The small diameter allows for easier insertion of
the introducer into the breast milk duct. The introducer 50 may be
formed of a stiff material such as a metal wire or a flexible
material such as plastic. In an embodiment of the invention, the
introducer 50 may be formed of Nitinol. Nitinol is preferred due to
its flexibility, durability, and biocompatibility. The introducer
50 may be constructed from a Nitinol wire that is ground to include
a tapered small diameter tip. In an alternative embodiment, the
introducer 50 may be formed of multiple materials or the same
materials having different stiffnesses. As a result, the introducer
50 may have sections that are more flexible than adjacent sections
of the same introducer 50. As a result, for example, the introducer
50 may have a first, stiff portion for guiding the introducer 50
within the ductal lumen and a second, flexible portion that allows
the introducer 50 to conform to the shape of the ductal lumen or
lumen branch into which it is introduced. In any of the
above-discussed embodiments, the introducer 50 may be coated with a
liquid or dry lubricant material that reduces the friction between
the introducer 50 and the breast duct during the introduction and
advancement of the introducer 50 in the duct.
[0050] The introducer 50 may be made of metal or plastics,
including shape memory metals and plastics, and may have a tapered
and/or an atraumatic tip for gently probing and accessing a breast
duct. Preferably, a tapered tip 52 will extend distally of the
catheter 40 during the introduction of the catheter 40 into the
breast duct. After access of the duct is complete, the catheter 40
may be slipped over the introducer 50 and positioned at a location
distal to the ductal sphincter.
[0051] In another embodiment of the invention, the proximal end of
the introducer 50 is formed into a ring shaped handle 51 (see FIGS.
14, 15 and 17). The advantage of the ring shaped handle 51 is that
is allows the device 10 to be used with one hand. The ring shaped
handle 51 may allow the practitioner to grasp the flexible side
arms 100 of the device 10 using their thumb and forefinger and to
manipulate the introducer 50 by using their index finger which may
be positioned through the ring shaped handle 51. The ring shaped
handle 51 may be constructed of a thermoplastic such as ABS or
polycarbonate or pellathane, and may be shaped in alternative forms
that will allow the practitioner to operate the device 10 with one
hand.
[0052] During the process of introducing the catheter 40 into the
duct, a ductal opening is located on the surface of a nipple by a
practitioner or attendant and an introducer 50 is advanced through
the ductal opening into the duct. The introducer 50 may be a long
flexible guide wire, a shorter dilator or any of the other
above-mentioned introducers. Prior to, or after the introducer 50
is positioned within the duct, the manifold hub 20 and catheter 40
may receive the introducer 50. As previously discussed, compressing
the flexible side arms 100 thus actuating the interlocking side
arms 110 away from the fitting 70 may open the fitting 70. Once
pressure is released from the flexible side arms 100, the
interlocking arms 110 are forced away from the manifold hub 20 by
the springs 120 thus closing the aperture 74 about the received
introducer 50 to form a fluid tight seal at the distal end of the
manifold hub 20 so that fluid does not exit the manifold hub 20
around the introducer 50 during the insertion catheter 40 into the
duct (See FIGS. 9, 10, 12, 13, 14, 15, and 16).
[0053] When the catheter 40 is positioned within the duct as
intended, the fitting 70 is opened and the introducer 50 removed.
The 70 may then be closed again to seal the hub 20. Fluid is then
introduced into the manifold hub 20, through the catheter 40 and
into the breast duct until resistance is met during the infusion.
At this time, it is assumed that the duct is filled. The infusion
tube, for example tube 34, may then be closed and the fluid allowed
to remain in the duct for a preselected time. During this
preselected time, the breast may be massaged and squeezed to
stimulate mixing of the wash fluid and ductal fluid, and also
ultimately to encourage the fluid to leave the duct and enter the
manifold hub 20. The collection tube, for example tube 36, may be
opened and the breast squeezed to urge the fluid to progress
through the catheter 40 and into the manifold hub 20. If desired,
when cloudy return fluid is seen in the hub 20 (which may be
transparent or include a transparent window), the infusion tube 34
may be opened and fluid infused into the manifold hub 20 to push
the ductal fluid sample that has collected in the hub 20 into the
collection tube 36 and a waiting collection receptacle.
Alternatively, and possibly additionally, aspiration pressure may
be applied within the manifold hub 20 and at the collection tube 36
to aspirate any fluid remaining in the hub 20 into the collection
receptacle. The process is repeated either following another
infusion of fluid into the duct or by another round of squeezing to
encourage return and collection of the infused fluid and cellular
material from within the breast duct.
[0054] In an embodiment, the method of lavage may include seating a
patient substantially upright in a chair during the lavage
procedure, rather than the standard or classic supine (face up)
position. Alternatively, the patient may be lavaged in a prone
position, face down, with nipples and breast down. The prone face
down position takes advantage of gravity and allows the breast
ducts to drain into the collection receptacle during the procedure
when the outflow port is open. Thus, as discussed above, the
ravaging procedure may include infusing the breast duct with a wash
fluid through an open inflow lumen while an outflow lumen is
closed; closing the inflow lumen when the duct is filled; squeezing
or massaging the breast or both; and opening the outflow lumen to
collect the wash fluid.
[0055] The cells collected may comprise ductal epithelial cells;
the ductal fluid collected may comprise molecular and cellular
material. Analysis of the ductal epithelial cells and/or the
molecular and cellular material in the ductal fluid may proceed as
described below discussing the diagnostic methods possible of these
collected materials. The collected cells and fluid and fluid
components may be analyzed. The lavage fluid including the ductal
cells may be analyzed for diagnostic purposes. Conditions in a
breast milk duct that are desirable to diagnose include a cancer or
precancer condition. The precancer condition may include atypical
ductal hyperplasia (ADH) or low-grade ductal carcinoma in situ
(LG-DCIS). The diagnostic agent may also have the ability to
diagnose other breast related conditions, including, e.g. fibrotic,
cystic or conditions relating to lactation. Diagnostic agents may
be mixed with the ductal fluid (either in the lavage procedure, or
after the fluid is collected).
[0056] The fluid infused into the duct to lavage the duct may
include known, biocompatible fluids. These lavage fluids may
include saline, phosphate buffered saline, a nonabsorbable fluid,
an isotonic solution, an osmotic solution, a hypotonic solution,
and a hypertonic solution. The wash fluid may comprise for example,
saline, phosphate buffered saline, a nonabsorbable fluid, an
isotonic solution, an osmotic solution, a hypotonic solution, a
hypertonic solution.a protein, a colloid, a sugar, a polymer,
mannitol, sorbitol, glucose, glycerol, sucrose, raffinose,
fructose, lactulose, sodium chloride, polyethyleneglycol (PEG),
maltodextrin, dextran (e.g. dextran 70), hydroxyethyl starch, fluid
gelatin, a synthetic colloid, an antibody, a binding protein, or
albumin.
[0057] As mentioned above, a diagnostic or therapeutic agent may be
introduced into a breast duct through the manifold hub 20 and
catheter 40. The introduced agent for infusing into the duct may
comprise a non-absorbable fluid and/or an oncotic agent and/or an
osmotic agent. The agent may be soluble. The agent may comprise a
molecule that is a protein, a colloid, a sugar, or a polymer. The
agent may be mannitol, sorbitol, glucose, glycerol, sucrose,
raffinose, fructose, lactulose, sodium chloride, polyethyleneglycol
(PEG), maltodextrin, dextran (e.g. dextran 70), hydroxyethyl
starch, fluid gelatin, or a synthetic colloid. The agent may
comprise a protein and the protein may be a binding protein or an
antibody. The binding protein may be albumin. Administering may
comprise administering locally, and local administration may
comprise administering intraductally. A system for increasing or
standardizing an amount of fluid collectable from a milk duct of a
breast may comprise infusing a nonabsorbable fluid and/or an
osmotic agent and/or an oncotic agent into the ductal lumen, a
medical tool for delivering the agent to the ductal lumen, and
instructions for use.
[0058] Any number of alternative combinations could exist for
defining the invention, which incorporate one or more elements from
the specification, including the description, claims, and drawings,
in various combinations or sub combinations. It will be apparent to
those skilled in the relevant technology, in light of the present
specification, that alternate combinations of aspects of the
invention, either alone or in combination with one or more elements
or steps defined herein, may be utilized as modifications or
alterations of the invention or as part of the invention. It may be
intended that the written description of the invention contained
herein covers all such modifications and alterations.
* * * * *