U.S. patent application number 13/660626 was filed with the patent office on 2013-02-28 for transbronchial needle aspiration device.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Sergey S. Grigoryants, Luis J. Maseda.
Application Number | 20130053727 13/660626 |
Document ID | / |
Family ID | 33451874 |
Filed Date | 2013-02-28 |
United States Patent
Application |
20130053727 |
Kind Code |
A1 |
Grigoryants; Sergey S. ; et
al. |
February 28, 2013 |
Transbronchial Needle Aspiration Device
Abstract
Transbronchial needle aspiration (TBNA) device. In one
embodiment, the device comprises a handle and a flexible catheter,
the handle having a bore, the proximal end of the catheter being
fixed within the handle bore. A protective tubular hub having a
flared distal end is press-fit coaxially within the distal end of
the catheter, the distal end of the catheter being sealed around
the distal end of the hub so as to define a distal opening. A
hollow needle having a sharp tip at its distal end is disposed
within the catheter, the needle tip being sized for insertion
through the distal opening of the catheter. The distal end of a
flexible wire is coupled to the proximal end of the needle, the
proximal end of the wire extending through the handle bore and
coupled to a button slide accessible through a slot in the handle.
The button slide is movable between a distal position in which the
needle tip extends through the distal opening of the catheter and a
proximal position in which the needle tip is disposed within the
hub. When in either its distal position or its proximal position, a
pawl on the button slide releasably engages a corresponding notch
on the handle to lock the button slide in place.
Inventors: |
Grigoryants; Sergey S.;
(Arlington, MA) ; Maseda; Luis J.; (Cambridge,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc.; |
Maple Grove |
MN |
US |
|
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
33451874 |
Appl. No.: |
13/660626 |
Filed: |
October 25, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12838996 |
Jul 19, 2010 |
8308655 |
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13660626 |
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11725348 |
Mar 19, 2007 |
7758514 |
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12838996 |
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10449826 |
May 30, 2003 |
7625346 |
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11725348 |
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Current U.S.
Class: |
600/567 |
Current CPC
Class: |
A61B 10/04 20130101;
A61B 2010/045 20130101; A61B 10/0283 20130101 |
Class at
Publication: |
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1.-9. (canceled)
10. A tissue sampling device, comprising: a flexible catheter
extending longitudinally from a proximal end to a distal end and
including a channel extending therethrough; a sampling needle
slidably received within the channel of the catheter and including
a distal tip; a wire extending through the channel and including a
distal end connected to the proximal end of the sampling needle to
move the sampling needle between a retracted position in which the
distal end thereof is disposed within the channel of the catheter
to an extended position in which the distal end thereof extends
distally beyond the distal end of the catheter; a handle coupled to
the proximal end of the catheter; and a sliding lock coupled to a
proximal end of the wire mounted within the handle to move the
sampling needle between the retracted and extended position, the
sliding lock including a releasable locking mechanism to lock the
sampling needle in the retracted position.
11. The device of claim 10, wherein the locking mechanism includes
a proximal notch extending through a proximal portion of the handle
and a pawl extending outward from the sliding lock, the pawl sized
and shaped to be received within the proximal notch to lock the
sampling needle in the retracted position.
12. The device of claim 10, wherein the locking mechanism includes
a distal notch extending through a distal portion of the handle,
the distal notch sized and shaped to receive the pawl therein to
releasably lock the sampling needle in the extended position.
13. The device of claim 10, wherein the sliding lock includes a
button extending through an elongated slot of the handle to an
exterior thereof so that pressing the button toward a longitudinal
axis of the device releases the lock mechanism.
14. The device of claim 13, wherein the button is longitudinally
slidable within the elongated slot to move the sampling needle
between the retracted position and the extended position.
15. The device of claim 10, further comprising a substantially
tubular hub disposed within the distal end of the catheter and
extending from a proximal end to a distal end.
16. The device of claim 15, wherein the distal end of the catheter
is inverted to retain the hub therein.
17. The device of claim 15, wherein the sampling needle includes a
shoulder extending thereabout such that when the sampling needle is
in the extended position, the shoulder abuts the proximal end of
the hub to form a seal.
18. The device of claim 10, further comprising a jacket mounted
over a portion of the wire and including a plurality of
longitudinal ribs extending therefrom to contact an interior of the
catheter such that the wire is centered therewithin.
19. The device of claim 10, further comprising a connector coupled
to the handle and configured to engage and receive a syringe
therein such that the syringe and the catheter are in fluid
communication.
20. The device of claim 10, further comprising a compressed spring
coaxially surrounding a distal portion of the wire.
21. A tissue sampling device, comprising: a flexible catheter
extending longitudinally from a proximal end to a distal end and
including a channel extending therethrough; a substantially tubular
hub disposed within the distal end of the catheter and extending
from a proximal end to a distal end; a sampling needle slidably
received within the channel of the catheter and including a distal
tip; a wire extending through the channel and including a distal
end connected to the proximal end of the sampling needle to move
the sampling needle between a retracted position in which the
distal end thereof is disposed within the hub to an extended
position in which the distal end thereof extends distally beyond
the distal end of the catheter; a handle coupled to the proximal
end of the catheter; and a sliding lock coupled to a proximal end
of the wire mounted within the handle to move the sampling needle
between the retracted and extended position, the sliding lock
including a releasable locking mechanism to lock the sampling
needle in the retracted position.
22. The device of claim 21, wherein the locking mechanism includes
a proximal notch extending through a proximal portion of the handle
and a pawl extending outward from the sliding lock, the pawl sized
and shaped to be received within the proximal notch to lock the
sampling needle in the retracted position.
23. The device of claim 22, wherein the locking mechanism includes
a distal notch extending through a distal portion of the handle,
the distal notch sized and shaped to receive the pawl therein to
releasably lock the sampling needle in the extended position.
24. The device of claim 21, wherein the sliding lock includes a
button extending through an elongated slot of the handle to an
exterior thereof so that pressing the button toward a longitudinal
axis of the device releases the lock mechanism.
25. The device of claim 24, wherein the button is longitudinally
slidable within the elongated slot to move the sampling needle
between the retracted position and the extended position.
26. The device of claim 21, wherein the distal end of the catheter
is inverted to retain the hub therein.
27. The device of claim 21, wherein the sampling needle includes a
shoulder extending thereabout such that when the sampling needle is
in the extended position, the shoulder abuts the proximal end of
the hub to form a seal.
28. The device of claim 21, further comprising a jacket mounted
over a portion of the wire and including a plurality of
longitudinal ribs extending therefrom to contact an interior of the
catheter such that the wire is centered therewithin.
29. The device of claim 21, further comprising a connector coupled
to the handle and configured to engage and receive a syringe
therein such that the syringe and the catheter are in fluid
communication.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 10/449,826, inventors Sergey S. Grigoryants et
al., filed Dec. 11, 2006, the disclosure of which is incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to tissue sampling
devices and relates more particularly to transbronchial needle
aspiration devices.
[0003] In order to diagnose and to stage lung cancer in a patient,
it is often necessary to biopsy a tissue sample from a nearby lymph
node of the patient. One type of technique that has been used in
the past to obtain such a tissue sample involves percutaneously
inserting a sampling needle through the patient's chest into the
patient's lung and then through the bronchial wall of the lung into
a nearby lymph node. Examples of devices adapted for percutaneous
tissue sampling are disclosed in the following U.S. patents, all of
which are incorporated herein by reference: U.S. Pat. No.
5,971,939, inventors DeSantis et al., which issued Oct. 26, 1999;
U.S. Pat. No. 5,713,368, inventor Leigh, which issued Feb. 3, 1998;
U.S. Pat. No. 4,799,494, inventor Wang, which issued Jan. 24, 1989;
and U.S. Pat. No. 4,766,907, inventors de Groot et al., which
issued Aug. 30, 1988.
[0004] Although the above-described percutaneous sampling technique
has proven satisfactory in terms of time and expense, such a
technique does have its shortcomings. One such shortcoming is the
risk of uncontrollable bleeding if the biopsy needle, which may be
quite large in diameter, pierces or shears a blood vessel. Another
shortcoming is the risk of pneumothorax, i.e., lung collapse,
resulting from the puncturing of the lung by the biopsy needle,
causing air to leak from the lung and to accumulate between the
lung surface and the chest cage. In fact, if pneumothorax is severe
enough, the patient may require a chest tube to drain air from the
chest cavity. Moreover, in extreme cases, the condition may be
fatal. Still another shortcoming is the risk of infection resulting
from the percutaneous insertion of the needle into the patient.
[0005] Accordingly, another technique that has been used to obtain
a lymph node tissue sample is transbronchial needle aspiration
(sometimes referred to as "TBNA"). In transbronchial needle
aspiration, the distal end of a bronchoscope is inserted through a
patient's mouth and to a neutral location within the patient's
lung, the proximal end of the bronchoscope not being inserted into
the patient and, instead, extending externally thereto. The distal
end of a TBNA device is then inserted through a working channel of
the bronchoscope, the proximal end of the TBNA device not being
inserted into the bronchoscope and, instead, extending externally
to the patient. The TBNA device typically comprises a catheter, a
wire longitudinally disposed within the catheter, a histology
sampling needle coupled to the distal end of the wire, a cap
coupled to the proximal end of the wire and accessible externally
to the patient for moving the wire relative to the catheter so as
to alternately extend the needle beyond the distal end of the
catheter and retract the needle into the catheter, and a port
accessible externally to the patient for coupling a syringe to the
proximal end of the catheter so that the syringe may provide
suction to the catheter.
[0006] The TBNA device is typically loaded into a bronchoscope with
its needle in a retracted position and with a syringe attached to
the port. Once confirmation is received that the distal end of the
TBNA device has passed entirely through the bronchoscope (such
confirmation typically being provided using a video channel of the
same bronchoscope), the bronchoscope and the TBNA device are
advanced together to the target site, and the needle is advanced to
its extended position. The needle is then inserted through the
bronchial wall of the patient and into a nearby lymph node. At this
time, the syringe is used to apply suction. In the unfortunate
event that the needle errantly penetrates a blood vessel, instead
of a lymph node, the application of suction causes blood to be
aspirated into the catheter and the syringe, where it is detected.
In such a case, the application of suction is discontinued and the
bloodied TBNA device is removed from the bronchoscope and the
patient. A fresh TBNA device is then loaded into the bronchoscope
and the patient in the manner described above, and another attempt
is made to penetrate the lymph node.
[0007] If, while suction is applied, it appears that the sampling
needle has penetrated a lymph node, as is desired, the catheter is
agitated to help shear tissue from the penetrated lymph node into
the sampling needle. With a tissue sample thus disposed within the
sampling needle, the needle is retracted into the catheter. The
TBNA device is then removed from the bronchoscope and the patient.
The needle is then advanced out of the catheter, and negative
suction is then used to expel the tissue from the sampling needle
onto a slide or the like for histological examination.
[0008] Examples of TBNA devices are disclosed in the following
patents, all of which are incorporated herein by reference: U.S.
Pat. No. 5,056,529, inventor de Groot, which issued Oct. 15, 1991;
U.S. Pat. No. 4,966,162, inventor Wang, which issued Oct. 30, 1990;
U.S. Pat. No. 4,890,626, inventor Wang, which issued Jan. 2, 1990;
U.S. Pat. No. 4,791,937, inventor Wang, which issued Dec. 20, 1988;
U.S. Pat. No. 4,766,906, inventor Wang, which issued Aug. 30, 1988;
U.S. Pat. No. 4,702,260, inventor Wang, which issued Oct. 27, 1987
U.S. Pat. No. 4,693,257, inventor Markham, which issued Sep. 15,
1987; U.S. Pat. No. 4,617,940, inventor Wang, which issued Oct. 21,
1986; U.S. Pat. No. 4,532,935, inventor Wang, which issued Aug. 6,
1985; and U.S. Pat. No. 4,249,541, inventor Pratt, which issued
Feb. 10, 1981.
[0009] Referring now to FIGS. 1 and 2, there are shown perspective
and enlarged fragmentary section views, respectively, of a
conventional, commercially available embodiment of a TBNA device,
said TBNA device being represented generally by reference numeral
11.
[0010] Device 11 comprises a handle or body 13. Body 13 is a
branched or T-shaped, tubular member shaped to include a first port
15 at its proximal end, a second port 17 at its distal end, and a
third port 19 extending perpendicularly to and between said first
port 15 and said second port 17. Each of first port 15, second port
17 and third port 19 is in fluid communication with the other two
ports. Third port 19 is adapted to receive a syringe for use in
providing suction to device 11.
[0011] Device 11 also comprises a flexible catheter 21. Catheter 21
has a proximal end and a distal end 23, the proximal end of
catheter 21 being fixedly mounted within second port 17.
[0012] Device 11 additionally comprises a metal hub or tip 25. Tip
25 is a generally tubular member having a proximal end 27 and a
distal end 29. A plurality of external barbs 31 are foamed on tip
25 intermediate to proximal end 27 and distal end 29. Proximal end
27 and barbs 31 are mounted within catheter 21 proximate to distal
end 23, with distal end 29 of tip 25 not being inserted into
catheter 21, but rather, externally abutting distal end 23 of
catheter 21.
[0013] Device 11 further comprises a flexible wire 35, wire 35
having a proximal end 37 and a distal end 39. Proximal end 37 of
wire 35 is fixed to a cap 41, cap 41 being adapted to be screwed
onto first port 15 of body 13. The remainder of wire 35 is threaded
through ports 15 and 17 of body 13 and into catheter 21, with
distal end 39 of wire 35 being disposed within catheter 21
proximate to distal end 23. A stop (not shown) is provided on wire
35, said stop being engageable with body 13 to delimit proximal
movement of wire 35.
[0014] Device 11 also comprises a histology sampling needle 51,
needle 51 having a proximal end 53 and a distal end 55. Proximal
end 53 of needle 51 is fixed to distal end 39 of wire 35. Distal
end 55 of needle 51 is shaped to include a sharp tip. A bore 57
extends proximally from distal end 55 of needle 51 to a side
opening 59 proximate to proximal end 53. An annular seal 61 is
mounted over needle 51 just distal to side opening 59, seal 61
being adapted to abut proximal end 27.
[0015] Device 11 may be used essentially in the fashion described
above to obtain a tissue sample. To place needle 51 in its advanced
position, i.e., so that distal end 55 of needle 51 extends beyond
tip 25, one moves cap 41 distally and screws cap 41 onto port 15.
Conversely, to withdraw or to retract needle, i.e., so that distal
end 53 of needle 51 indisposed within tip 25, one unscrews cap 41
from port 15 and moves cap 41 proximally relative to body 13 until
restrained by the aforementioned stop.
[0016] Although device 11 is satisfactory in many respects, the
present inventors have identified certain shortcomings therewith.
One such shortcoming is that, whereas device 11 includes means for
retaining needle 51 in its extended position (namely, by screwing
cap 41 onto port 15), device 11 does not include corresponding
means for retaining needle 51 in a retracted position.
Consequently, if one wishes to ensure that needle 51 is not
advanced through distal end 23 of catheter 21 at an inopportune
moment, one must constantly pull cap 41 proximally relative to body
13. However, as can readily be appreciated, such a requirement
substantially complicates the manipulation of device 11, especially
by an individual operator.
[0017] Another shortcoming identified by the present inventors with
device 11 is the branched shape of body 13 and the resultant
orientation of a syringe coupled thereto through port 19. More
specifically, the present inventors have found that the
perpendicular orientation of a syringe relative to the longitudinal
axis of catheter 21 makes device 11 cumbersome and difficult to
manipulate by an individual operator.
[0018] Yet another shortcoming identified by the present inventors
with device 11 is that, when needle 51 is in its extended position
and a load force is applied to the distal end 53 of needle 51 (such
as is the case when needle 51 is used to penetrate a tissue),
needle 51 tends to be moved proximally relative to catheter 21,
thereby effectively shortening the usable length of needle 51 for
penetrating the tissue. Such a loss in the usable length of needle
51 occurs because wire 35 has an outer diameter that is
considerably smaller than the inner diameter of catheter 21, giving
wire 35 room to move laterally within catheter 21. Consequently,
when catheter 21 is bent, as is the case when device 11 is deployed
in a patient, and a load force is applied to needle 51, wire 35
tends to take the longest possible path through catheter 21.
[0019] Conversely, when cap 41 is pulled back relative to catheter
21 to its fully retracted position and catheter 21 is bent to a
substantial degree, needle 51 may not fully retract relative to
catheter 21. This is because of the aforementioned difference
between the outer diameter of wire 35 and the inner diameter of
catheter 21 and the tendency of wire 35 to take the shortest
possible path through catheter 21. As can readily be appreciated,
if needle 51 cannot be fully retracted when sampling is not being
performed, damage may occur to equipment, operators and/or the
patient.
[0020] Still another shortcoming identified by the present
inventors with device 11 is that tip 25 is susceptible to becoming
dislodged distally from catheter 21. As can readily be appreciated,
if tip 25 were to become separated from catheter 21, the risks to
the patient would be considerable. Such a susceptibility of tip 25
to becoming dislodged is due, in part, to the fact that tip 25 is
held within catheter 21 only by the friction-fit of catheter 21
over barbs 31 and proximal end 27. This susceptibility is
exacerbated by the fact that, when needle 51 is advanced to its
extended position, seal 61 applies a distally directed force
against tip 25. In addition, because catheter 21 has a tendency to
bulge radially outwardly in the area where it overlies barbs 31,
this bulged area of catheter 21 is susceptible to becoming snagged
on the distal end of a bronchoscope when device 11 is retracted
into the bronchoscope. Such snagging results in additional distally
directed force being applied to tip 25 relative to catheter 21.
[0021] Still yet another shortcoming identified by the present
inventors with device 11 is that distal end 29 of tip 25, which is
not disposed within catheter 21, but rather, lies externally
thereto, has a tendency to scratch and, thus, to damage the working
channel of a bronchoscope.
[0022] Still a further shortcoming identified by the present
inventors with device 11 is that, when needle 51 is retracted,
distal end 55 of needle 51 has a tendency to be withdrawn
proximally from hub 25. This requires needle 51 to be re-aligned
properly with hub 25 in order for needle 51 to be re-inserted into
hub 25.
[0023] Still yet a further shortcoming identified by the present
inventors with device 11 is that seal 61 often does not create an
air-tight seal against tip 25 when needle 51 is placed in its fully
extended position; as a result, the full extent of the vacuum force
applied to bore 57 of needle 51 by the syringe is frequently not
experienced.
SUMMARY OF THE INVENTION
[0024] It is an object of the present invention to provide a tissue
sampling device suitable for use in transbronchial needle
aspiration (TBNA).
[0025] It is another object of the present invention to provide a
tissue sampling device as described above that overcomes at least
some of the shortcomings associated with existing TBNA devices.
[0026] It is still another object of the present invention to
provide a device as described above that can be mass-produced
relatively inexpensively, that has a minimal number of parts, and
that is easy to operate.
[0027] In furtherance of the above and other objects to be
described or to become apparent from the description below, there
is provided, according to one aspect of the invention, a tissue
sampling device suitable for use in transbronchial needle
aspiration, said tissue sampling device comprising (a) a flexible
catheter, said flexible catheter having a proximal end and a distal
end; (b) a sampling needle, said sampling needle being insertable
into said flexible catheter and being shaped to include a distal
tip; (c) means coupled to said sampling needle for moving said
sampling needle between a first position wherein said distal tip of
said sampling needle is disposed within said flexible catheter and
a second position wherein said distal tip of said sampling needle
extends distally beyond said distal end of said flexible catheter;
and (d) means for retaining said sampling needle at said first
position in a releasably locked fashion.
[0028] According to another aspect of the invention, there is
provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a flexible catheter, said flexible catheter having a
proximal end and a distal end; (b) a sampling needle, said sampling
needle being disposed at said distal end of said flexible catheter
and having a distal tip; and (c) a handle assembly, said handle
assembly being secured to said proximal end of said flexible
catheter, said handle assembly including a port adapted to receive
a syringe in such a manner as to fluidly interconnect said syringe
to said flexible catheter, said port being oriented parallel to
said proximal end of said flexible catheter.
[0029] According to yet another aspect of the invention, there is
provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a flexible catheter, said flexible catheter having a
proximal end, a distal end and an inner diameter; (b) a wire, said
wire extending substantially coaxially within said flexible
catheter, said wire having a proximal end, a distal end and an
outer diameter, said outer diameter of said wire being
substantially less than said inner diameter of said flexible
catheter; (c) a sampling needle, said sampling needle being
positioned at said distal end of said flexible catheter and being
coupled to said distal end of said wire; (d) means inserted over at
least a portion of said wire for centering said wire within said
flexible catheter while still providing a space for fluid flow; and
(e) a handle assembly, said flexible catheter being fixed at said
proximal end to said handle assembly.
[0030] According to still yet another aspect of the invention,
there is provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a flexible catheter, said flexible catheter having a
proximal end and a distal end; (b) a hub, said hub being
substantially tubular and having a proximal end and a distal end,
said hub being disposed within said flexible catheter, with said
distal end of said flexible catheter being inverted so as to retain
said hub distally within said flexible catheter; (c) a sampling
needle, said sampling needle having a tip; and (d) means coupled to
said sampling needle for moving said sampling needle between a
first position wherein said tip of said sampling needle is disposed
within said hub and a second position wherein said tip of said
sampling needle extends distally beyond said distal end of said
flexible catheter.
[0031] According to a further aspect of the invention, there is
provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a flexible catheter, said flexible catheter having a
proximal end, a distal end and an inner diameter; (b) a wire, said
wire extending within said flexible catheter, said wire having a
proximal portion and a distal portion, said distal portion having a
decreased thickness as compared to said proximal portion; (c) a
sampling needle, said sampling needle being positioned at said
distal end of said flexible catheter and being coupled to said
wire; and (d) a compressed spring surrounding and secured to at
least a portion of said distal portion of said wire.
[0032] According to still a further aspect of the invention, there
is provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a handle, said handle comprising a body and a cover,
said body and said cover together defining a top, a bottom and a
distal end, said top having a slot, said distal end having a bore;
(b) a button slide, said button slide being slidably mounted in
said handle and including a button, said button extending upwardly
through said slot for manipulation by an operator; (c) a flexible
catheter, said flexible catheter having a proximal end and a distal
end, said proximal end being mounted within said bore in said
handle; (d) a wire, said wire having a proximal end and a distal
end, said proximal end of said wire being coupled to said button
slide; and (e) a sampling needle, said sampling needle being
coupled to said distal end of said wire, said sampling needle
having a distal tip; (f) wherein said button slide is movable
between a first position in which said distal tip of said sampling
needle is positioned within said flexible catheter and a second
position in which said distal tip of said sampling needle extends
distally past said proximal end of said flexible catheter.
[0033] According to still yet a further aspect of the invention,
there is provided a tissue sampling device suitable for use in
transbronchial needle aspiration, said tissue sampling device
comprising (a) a flexible catheter, said flexible catheter having a
proximal end and a distal end; (b) a hub, said hub being
substantially tubular and having a proximal end and a distal end,
said hub being disposed within said flexible catheter proximate to
said distal end thereof; (c) a sampling needle, said sampling
needle having a distal tip and a shoulder; and (d) means coupled to
said sampling needle for moving said sampling needle between a
first position wherein said distal tip of said sampling needle is
disposed within said hub and a second position wherein said distal
tip of said sampling needle extends distally beyond said distal end
of said flexible catheter; (e) wherein said shoulder of said
sampling needle is adapted to directly abut said proximal end of
said hub to form a seal therewith when said sampling needle is
placed in said second position.
[0034] For purposes of the present specification and claims,
various relational terms like "top," "bottom," "proximal,"
"distal," "upper," "lower," "front," and "rear" are used to
describe the present invention when said invention is positioned in
a given orientation. It is to be understood that, by altering the
orientation of the invention, certain relational terms may need to
be adjusted accordingly.
[0035] Additional objects, as well as features and advantages, of
the present invention will be set forth in part in the description
which follows, and in part will be obvious from the description or
may be learned by practice of the invention. In the description,
reference is made to the accompanying drawings which form a part
thereof and in which is shown by way of illustration various
embodiments for practicing the invention. The embodiments will be
described in sufficient detail to enable those skilled in the art
to practice the invention, and it is to be understood that other
embodiments may be utilized and that structural changes may be made
without departing from the scope of the invention. The following
detailed description is, therefore, not to be taken in a limiting
sense, and the scope of the present invention is best defined by
the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The accompanying drawings, which are hereby incorporated
into and constitute apart of this specification, illustrate various
embodiments of the invention and, together with the description,
serve to explain the principles of the invention. In the drawings
wherein like reference numerals represent like parts:
[0037] FIG. 1 is a perspective view of a conventional transbroncial
needle aspiration (TBNA) device;
[0038] FIG. 2 is a fragmentary, section view of the TBNA device of
FIG. 1, showing the distal portion thereof;
[0039] FIG. 3 is a side view of one embodiment of a TBNA device
constructed according to the teachings of the present invention,
the TBNA device being shown with its needle in the retracted
position;
[0040] FIG. 4 is a fragmentary longitudinal section view of the
TBNA device of FIG. 3, the TBNA device being shown with its needle
in the retracted position;
[0041] FIG. 5 is an exploded perspective view of the TBNA device of
FIG. 3;
[0042] FIGS. 6(a) and 6(b) are fragmentary section views of the
TBNA device of FIG. 3, showing the distal portion thereof with the
needle in its retracted and extended positions, respectively;
[0043] FIGS. 7(a) through 7(f) are perspective, side, top,
proximal, distal and longitudinal section views, respectively, of
the handle body shown in FIG. 3;
[0044] FIGS. 8(a) through 8(e) are perspective, top, bottom, left
longitudinal section and right longitudinal section views,
respectively, of the handle cover shown in FIG. 3;
[0045] FIGS. 9(a) through 9(e) are perspective, top, bottom, right
side and left longitudinal section views, respectively, of the
button slide shown in FIG. 3;
[0046] FIG. 10(a) through 10(e) are perspective, proximal, distal,
right side and left longitudinal section views, respectively, of
the syringe connector shown in FIG. 3;
[0047] FIGS. 11(a) through 11(d) are perspective, proximal, right
side and right longitudinal section views, respectively, of the
strain relief member shown in FIG. 3;
[0048] FIGS. 12(a) and 12(b) are perspective and right longitudinal
section views, respectively, of the hub shown in FIG. 3;
[0049] FIG. 13 is a fragmentary right side view of the wire shown
in FIG. 3;
[0050] FIGS. 14(a) and 14(b) are proximal and side views,
respectively, of the jacket shown in FIG. 3;
[0051] FIGS. 15(a) and 15(b) are right side and enlarged right
longitudinal section views, respectively, of the spring shown in
FIG. 3;
[0052] FIGS. 16(a) through 16(c) are fragmentary right side,
fragmentary right longitudinal section and fragmentary enlarged
right longitudinal section views, respectively, of the combination
of the wire, the jacket and the spring shown in FIG. 3;
[0053] FIG. 16(d) is an enlarged right side view showing the distal
ends of the spring and the wire shown in FIG. 16(a);
[0054] FIGS. 17(a) through 17(d) are perspective, left side, top
and enlarged fragmentary left longitudinal section views,
respectively, of the needle shown in FIG. 3;
[0055] FIGS. 18(a) through 18(c) are perspective, top and left side
views, respectively, of a first alternate needle; and
[0056] FIGS. 19(a) through 19(c) are perspective, top and left side
views, respectively, of a second alternate needle.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0057] Referring now to FIGS. 3, 4, 5, 6(a) and 6(b), there are
shown various views, respectively, of one embodiment of a
transbronchial needle aspiration (TBNA) device constructed
according to the teachings of the present invention, said TBNA
device being represented generally by reference numeral 101.
[0058] Device 101 comprises a handle assembly 103, a wire 105, a
flexible catheter 107, a sampling needle 109, a hub 111, a jacket
113 and a spring 115.
[0059] Handle assembly 103, in turn, comprises a body 117, a cover
119, a button slide 121, a syringe connector 123 and a strain
relief member 125.
[0060] Referring now to FIGS. 7(a) through 7(f), body 117 is a
unitary, generally C-shaped member, preferably made of a durable
molded plastic or another similarly suitable material, comprising a
top portion 131, a distal end portion 133 and a bottom portion 135,
the sides and proximal end of body 117 being open. Top portion 131,
distal end portion 133 and bottom portion 135 collectively define a
longitudinally-extending cavity 139, which, as will be described
below, is shaped to accommodate a syringe or similar aspirating
device.
[0061] Top portion 131 is shaped to include a pair of rails 141-1
and 141-2, rails 141-1 and 141-2 being separated by a slot 142
whose purpose will become apparent below. A first pair of detents
143-1 and 143-2 are formed on the outer side surface of rail 141-1,
and a second pair of detents 145-1 and 145-2 are formed on the
outer side surface of rail 141-2, second detents 145-1 and 145-2
being staggered relative to first detents 143-1 and 143-2. As will
be described below, detents 143-1, 143-2, 145-1 and 145-2 are used
in the coupling together of body 117 and cover 119 to form a
handle.
[0062] Distal end portion 133 includes a proximal surface 147,
proximal surface 147 being shaped to receive syringe connector 123.
Distal end portion 133 also includes a distally extending post 149.
A bore 151 (which is seen best in FIG. 7(f)) extends longitudinally
through post 149 and continues through the remainder of distal end
portion 133 to cavity 139. Bore 151 includes a distal portion 151-1
of comparatively greater cross-sectional diameter and a proximal
portion 151-2 of comparatively lesser cross-sectional diameter,
distal portion 151-1 extending for most of the length of bore 151.
As will be described further below, distal portion 151-1 is sized
to securely receive the proximal end of catheter 107, with the
proximal end of wire 105 passing through proximal portion 151-2. A
transverse opening 153 is also provided in distal end portion 133,
transverse opening 153 intersecting distal portion 151-1 of bore
151 at an inteiniediate location thereof.
[0063] Bottom portion 135 has a top surface 155 and a bottom
surface 157. Top surface 155 is contoured to receive a syringe or
similar aspirating device thereon. Bottom surface 157 is contoured
to fit ergonomically within the hand of an operator.
[0064] Referring now to FIGS. 8(a) through 8(e), cover 119 is a
unitary, generally trough-shaped member, preferably made of a
durable molded plastic or another similarly suitable material,
comprising a top portion 161, a pair of side portions 163-1 and
163-2, and a proximal end portion 165, the bottom and the distal
end of cover 119 being open. Top portion 161 is shaped to include
an elongated, longitudinally-extending slot 167, through which, as
will be further described below, the button portion of button slide
121 is adapted to extend. Top portion 161 is also shaped to include
a proximal pair of notches 169-1 and 169-2 and a distal pair of
notches 171-1 and 171-2, notches 169-1 and 169-2 being disposed on
opposite sides of slot 167 near the proximal end thereof, notches
171-1 and 171-2 being disposed on opposite sides of slot 167 near
the distal end thereof. As will be described further below,
proximal notches 169-1 and 169-2 and distal notches 171-1 and 171-2
are alternately adapted to receive, in a releasably locking
fashion, a pair of pawls formed on button slide 121, notches 169-1
and 169-2 being adapted to receive said pawls in such a manner as
to retain button slide 121 at a proximal position (as in FIGS. 3, 4
and 6(a)), notches 171-1 and 171-2 being adapted to receive said
pawls in such a manner as to retain button slide 121 at a distal
position (as in FIG. 6(b)).
[0065] A first pair of recesses 175-1 and 175-2 are formed on the
inside surface of side portion 163-1, and a second pair of recesses
177-1 and 177-2 are formed on the inside surface of side portion
163-2. Recesses 175-1 and 175-2 are adapted to securely receive
detents 143-1 and 143-2, respectively, of rail 141-1, and recesses
177-1 and 177-2 are adapted to securely receive detents 145-1 and
145-2, respectively, of rail 141-2. In this manner, body 117 and
cover 119 may be secured to one another to form a handle. With body
117 and cover 119 thus coupled together, proximal end portion 165
of cover 119 is situated within the open proximal end of body 117,
the open distal end of cover 119 terminates just proximally of post
149, and top portion 161 of cover 119 is spaced, for reasons to
become apparent below, from the top surfaces of rails 141-1 and
141-2.
[0066] Referring now to FIGS. 9(a) through 9(e), button slide 121
is a unitary, generally rectangular member, preferably made of a
durable molded plastic or other similarly suitable material,
comprising an outer frame portion 181 and an inner tab portion 183.
Frame portion 181, which is generally planar, is shaped to include
a proximal end 185, a distal end 187, and a pair of sides 189-1 and
189-2, all of which collectively define an interior cavity 190. For
reasons to become apparent below, frame portion 181 is
appropriately dimensioned so that sides 189-1 and 189-2 are adapted
to ride along the top surfaces of rails 141-1 and 141-2,
respectively, and below a pair of ribs 188-1 and 188-2,
respectively, formed on cover 119 (see FIGS. 8(c) through
8(e)).
[0067] Proximal end 185 of frame 181 is shaped to include a
downwardly extending central portion 191, central portion 191 being
dimensioned to extend downwardly a short distance through slot 142
of body 117. A slot 193 is provided in central portion 191, slot
193 extending upwardly a short distance from the bottom surface of
portion 191. Slot 193 is shaped to include a pair of substantially
orthogonal arms 193-1 and 193-2, which, as will be described
further below, are adapted to matingly receive the proximal end of
wire 105.
[0068] Distal end 187 is shaped to include a generally rectangular
central portion 195, central portion 195 being dimensioned to
extend downwardly a short distance through slot 142. A bore 197 is
provided in central portion 195, bore 197 being aligned with arm
193-1 of slot 193 to receive an intermediate length of wire
105.
[0069] Inner tab portion 183 is generally trapezoidal in shape and
includes a proximal end 201, a distal end 203 and a pair of sides
205-1 and 205-2. Proximal end 201 is hingedly connected to proximal
end 185 of frame 181, with distal end 203 being free and upwardly
biased. A pair of pawls 207-1 and 207-2 extend upwardly from sides
205-1 and 205-2, respectively, of tab portion 183. Pawls 207-1 and
207-2 are adapted to be received either within proximal notches
169-1 and 169-2, respectively, or distal notches 171-1 and 171-2,
respectively, of cover 119.
[0070] A button 209 is provided on the top surface of tab portion
183 proximate to distal end 203, button 209 being adapted to extend
upwardly through slot 167 of cover 119. With button 209 thus
accessible through slot 167, an operator may use button 209 to
exert downward pressure on tab portion 183 to disengage pawls 207-1
and 207-2 from either notches 169-1 and 169-2 or notches 171-1 and
171-2, as well as to slide button slide 121 proximally or distally
along rails 141-1 and 141-2. Gripping elements 211 extend outwardly
from the top of button 209 to facilitate manipulation of button
209.
[0071] Referring now to FIGS. 10(a) through 10(e), syringe
connector 123 is a generally teardrop-shaped unitary member,
preferably made of a durable molded plastic or another similarly
suitable material, comprising a proximal end 221, a distal end 223
and a side 225. A port 227 extends proximally a short distance from
proximal end 221, port 227 defining a tapered cavity 229 adapted to
receive the medical luer of a syringe. The proximal end of port 227
is shaped to include a pair of radially outwardly extending tabs
229-1 and 229-2, tabs 229-1 and 229-2 being adapted for threaded
engagement with the internally threaded sleeve of a syringe. Port
227 is oriented so that, with a syringe connected thereto and with
connector 123 mounted on body 117, said syringe extends
longitudinally through cavity 139 and on top of bottom portion 155
of body 117.
[0072] An oval-shaped ridge 231 extends distally a short distance
from distal end 223, ridge 231 being receivable within a
correspondingly shaped groove 235 provided in distal end portion
133 of body 117 (see FIG. 7(d)). An adhesive (not shown) may be
used, if desired, to more securely retain ridge 231 within groove
235. Ridge 231 defines an oval-shaped cavity 237 that is adapted to
bounded proximally by distal end 223 of syringe connector 123 and
distally by distal end portion 133 of body 117. Cavity 237 is
adapted to be aligned with distal portion 151-1 of bore 151 of body
117 for reasons to become apparent below.
[0073] A first transverse bore 241 extending between proximal end
221 and distal end 223 is provided in syringe connector 123, bore
241 being in fluid communication with each of cavity 229 and cavity
237. Accordingly, by connecting a syringe to connector 121, one can
apply negative or positive suction force through cavity 229, bore
241, and cavity 237 and into bore 151.
[0074] A second transverse bore 245 extending between proximal end
221 and distal end 223 is provided in syringe connector 123, bore
245 being alignable with bore 151 for an intermediate portion of
wire 105 to pass therethrough.
[0075] Referring now to FIGS. 11(a) through 11(d), strain relief
member 125 is a unitary member, preferably made of a durable molded
plastic or another similarly suitable material, comprising a
generally cylindrical proximal portion 251 and a frustoconical
distal portion 253. A longitudinal bore 255 extends the length of
member 125, the proximal portion 256 of bore 255 being shaped to
receive, among other things, post 149 of body 117, the distal
portion 257 of bore 255 being shaped to receive, and thereby
provide strain relief to, a length of catheter 107 proximate to the
proximal end of catheter 107.
[0076] Referring now to FIGS. 12(a) and 12(b), hub 111 is a unitary
tubular member, preferably made of stainless steel or another
similarly suitable material, comprising a proximal portion 261 and
a distal portion 263. Proximal portion 261 is straight and has a
uniform diameter over its entire length. Distal portion 263 flares
outwardly from proximal portion 261 to a distal end 265 for reasons
to become apparent below, (It should be understood that the
proximal end could also be outwardly flared, if desired.)
[0077] Referring back to FIGS. 3, 4, 5, 6(a) and 6(b), catheter 107
is a unitary flexible tubular member, preferably made of nylon or
another similarly suitable material, having a length of about 160
cm and comprising a proximal end 271 and a distal end 273. Proximal
end 271 of catheter 107 is coaxially received and fixedly secured
within distal portion 151-1 of bore 151. As seen best in FIGS. 6(a)
and 6(b), catheter 107 is dimensioned relative to hub 111 so that
hub 111 may be press-fit into catheter 107 through distal end 273,
with distal end 273 of catheter 107 being inverted over distal end
265 of hub 111 and shaped to define an opening 275. Although not
shown herein, the shaping of distal end 273 of catheter 107 around
distal end 265 of hub 111 to define opening 275 may be performed by
inserting a mandrel through hub 111 and catheter 107 and then using
heat to shape distal end 273 to said mandrel. Preferably, opening
275 of catheter 107 is dimensioned to conform closely to the outer
diameter of a shaft 277 of needle 109 to promote an air-tight seal
between shaft 277 and catheter 107 when needle 109 is extended
through opening 275 (as in FIG. 6(b)). Alternatively, one could
position an annular seal (not shown) coaxially within catheter 107
between distal end 273 of catheter 107 and distal end 265 of hub
111, said annular seal being appropriately dimensioned and made of
a suitable material to promote an air-tight interface with the
outer surface of needle 109 inserted therethrough.
[0078] Referring now to FIG. 13, wire 105 is a solid flexible
unitary member, preferably made of stainless steel or another
similarly suitable material, comprising a proximal portion 281 and
a distal portion 283. Proximal portion 281, which has a length of
about 52 inches and a thickness of about 0.022 inch, includes a
proximal end 285. Proximal end 285 is bent into an L-shape and is
adapted to be securely received within slot 193 of button slide
121. The remainder of proximal portion 281 is adapted to be
inserted through bore 197 of button slide 121, through an annular
seal 291 (see FIGS. 4 and 5) positioned between button slide 121
and syringe connector 123, through bore 245 of syringe connector
123, through bore 151 of body 103 and into catheter 107,
terminating a few inches proximally of hub 111.
[0079] Distal portion 283, which has a length of about 2 inches, is
shaped to include a proximal segment 287-1 and a distal segment
287-2. Proximal segment 287-1 has a length of about 0.2 inch and
decreases uniformly in thickness from about 0.022 inch at its
proximal end to about 0.01 inch at its distal end. Distal segment
287-2, which extends distally from segment 287-1, has a length of
about 1.8 inch and a uniform thickness of about 0.01 inch over its
entire length.
[0080] As will be described further below, the reason for providing
a reduced thickness over much of the length of distal portion 283
of wire 105 is to endow distal portion 283 with additional
flexibility, which may be advantageous in enabling distal portion
283 to be delivered to certain remote sampling sites accessible
only through contorted paths. Endowing distal portion 283 of wire
105 with additional flexibility may also be advantageous in
allowing passage through aggressive scope channels. Notwithstanding
the above, distal portion 283 may be varied in size and/or shape
depending upon the characteristics desired therefor.
[0081] Referring now to FIGS. 14(a) and 14(b), jacket 113 is a
unitary tubular member, preferably made of arnitel, polypropylene
or another similarly suitable material. Jacket 113 is shaped to
include a proximal end 301, a distal end 303, a central bore 305,
and a plurality of external ribs 307-1 through 307-4. Bore 305 is
appropriately dimensioned to securely receive wire 105 by a
friction-fit, with proximal end 301 of jacket 113 being aligned
with that portion of wire 105 that is disposed within distal
portion 151-1 of bore 151 when button slide 121 is in its retracted
position and with distal end 303 of jacket 113 being aligned with
that portion of wire 105 that is positioned just proximally of
distal portion 283. An alternative to the aforementioned
friction-fit between wire 105 and jacket 113 is a sliding-fit
between wire 105 and jacket 113. Such a sliding-fit allows wire 105
to move with respect to jacket 113 in situations where jacket 113
encounters resistance when sliding within catheter 107. This allows
for movement of wire 105 to occur in the manner of least
resistance.
[0082] Ribs 307-1 through 307-4, which extend longitudinally along
the entire length of jacket 113, are evenly spaced about the
circumference of jacket 113. Each of ribs 307-1 through 307-4
extends in a direction radially outwardly from bore 305 and is
generally triangular in shape, as viewed from an end of jacket 113.
Ribs 307-1 through 307-4 are appropriately sized so that at least
one of their respective vertices 309-1 through 309-4 is adapted to
be in contact with the inside surface of catheter 107. In this
manner, ribs 307-1 through 307-4 serve to keep wire 105
substantially centered within catheter 107 throughout its length
(even when a load force is applied to needle 109) while, at the
same time, providing ample space (i.e., between adjacent ribs 307)
for fluid flow within catheter 107.
[0083] As can readily be appreciated, there are a myriad number of
ways in which ribs 307-1 through 307-4 may be changed in size,
shape and number while still satisfying the foregoing objectives of
keeping wire 105 centered within catheter 107 and providing an
ample volume within catheter 107 for fluid flow. (For examples of
these and other modifications, see commonly-assigned U.S. Pat. No.
6,454,702 and commonly-assigned U.S. patent application Ser. No.
09/716,710, both of which are incorporated herein by
reference.)
[0084] In another embodiment (not shown), one could replace jacket
113 with a plurality of beads or similarly suitable elements
over-molded around wire 105 at spaced intervals thereof, said beads
being sized to engage the inside surface of catheter 107 and, thus,
to keep wire 105 centered within catheter 107. If desired, said
beads could have longitudinal grooves or channels oriented along
the longitudinal axis of catheter 107 to allow maximum fluid flow
from the proximal to the distal portions of catheter 107 and vice
versa. The dimensions of said beads may also be chosen so as to
regulate fluid flow by controlling the gap between the bead surface
and catheter 107.
[0085] In still another embodiment (not shown), one could replace
both jacket 113 and wire 105 with a wire that is shaped (e.g., by
machining, stamping, etc.) to include one or more elements adapted
to keep said wire centered within catheter 107.
[0086] Referring now to FIGS. 15(a) and 15(b), spring 115 is a
unitary member, preferably made of stainless steel or another
similarly suitable material, comprising a plurality of closely
spaced or compressed coils 311 terminating at a proximal end 313
and a distal end 315. (Although coils 311 are shown in the present
embodiment having a rectangular transverse cross-sectional shape,
it is to be understood that coils 311 are not limited to a
rectangular transverse cross-sectional shape and could have, for
example, a circular transverse cross-sectional shape or the like.)
As seen best in FIGS. 16(a) through 16(c), spring 115 coaxially
surrounds distal portion 283 of wire 105, with proximal end 313 of
spring 115 being secured, preferably by a weld 314-1 (see FIG.
16(c)) or like means, to wire 105 just proximally of segment 287-1
and with distal end 315 of spring 115 being secured, preferably by
a weld 314-2 (see FIG. 16(d)) or like means, to the distal end of
segment 287-2. Spring 115 has a uniform inner diameter of about
0.026 inch, which is slightly greater than the thickness of wire
105, and a uniform outer diameter of about 0.034 inch.
[0087] The purpose of spring 115 is to provide greater column
strength to distal portion 283 of wire 105, i.e., to make distal
portion 283 less likely to buckle when a compressive force is
applied thereto. Such increased column strength is desirable since,
as noted above, distal portion 283 has a decreased thickness as
compared to the remainder of wire 105. One advantageous feature of
spring 115 is that, whereas spring 115 cannot be compressed and,
therefore, provides the aforementioned column strength to distal
portion 283, spring 115 can be bent and, therefore, does not
substantially diminish the flexibility of distal portion 283.
[0088] Referring now to FIGS. 17(a) through 17(d), needle 109 is a
unitary member, preferably made of stainless steel or another
similarly suitable material, comprising a proximal base portion 321
and a distal stem portion 323. Base portion 321, which is generally
cylindrical in shape, is about 0.2 inch in length and includes a
proximal end 325, a rounded distal end 327, a longitudinal bore 329
and an upwardly-facing slot 331, slot 331 extending distally from
proximal end 325 to a point just prior to distal end 327. Slot 331
is bounded by a flat edge 332 onto which wire 105 may be secured,
preferably by welding or like means.
[0089] Stem portion 323, which is generally cylindrical in shape
and coaxial with base portion 321, is about 0.8 inch in length and
includes a proximal end 333, a distal end 335 and a longitudinal
bore 337. Distal end 335 is shaped to define an upwardly-facing,
open-ended tip, said tip being appropriately shaped and dimensioned
to acquire a tissue sample for biopsy. As in the embodiment shown,
slot 331 and the tip of needle 109 both face in the same direction;
in this manner, wire 105 may be (but is not necessarily) welded to
needle 109 on the same side as the tip. This permits force applied
to the tip to be transmitted along the axis of wire 105. When
joining wire 105 to needle 109, a small space is left between the
distal end of wire 105 and the distal end of slot 331, said space
being appropriately sized to permit fluid flow between catheter 107
and longitudinal bores 337 and 329 of needle 109 while, at the same
time, preventing passage of the sample from needle 109 into
catheter 107. This gap may be varied in size and/or length to
regulate fluid flow for a given purpose.
[0090] Rounded distal end 327 of base portion 321 and proximal end
333 of stem portion 323 together define a shoulder that is shaped
to abut directly the proximal end of hub 111 in such a way as to
form an air-tight seal therewith when needle 109 is placed in its
advanced position.
[0091] As discussed above, the outer diameter of stem portion 323
is appropriately dimensioned to form a tight seal with distal end
273 of catheter 107 when needle 109 is moved to its extended
position (see FIG. 6(b)). In addition, as noted above, the shoulder
formed by rounded distal end 327 of base portion 321 and proximal
end 333 of stem portion 323 is appropriately dimensioned to engage
proximal end 261 of hub 111 so as to form a seal therewith, as well
as to delimit distal movement of needle 109 (and, in so doing,
prevent needle 109 from being lost distally from the remainder of
device 101 and, perhaps, becoming lost in a patient). Although not
shown, one could, if desired, enhance the seal formed between the
shoulder of needle 109 and proximal end 261 of hub 111 by
heat-shrinking an elastomeric sleeve over the shoulder of needle
109, said sleeve conforming to the shape of the shoulder and
forming a sealing interface with the proximal end 261 of hub 111.
(It should be noted that the use of such an elastomeric sleeve in
device 101 would make considerably more difficult any reprocessing
of device 101.)
[0092] Referring now to FIGS. 18(a) through 18(c), there are shown
various views of a first alternate needle usable instead of needle
109 in device 101, said first alternate needle being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 359.
[0093] Needle 359 is a unitary structure shaped to include a stem
portion 361 and a base portion 363. Stem portion 361, which is
substantially identical to stem portion 323 of needle 109, is a
generally tubular element shaped to include a proximal end 365 and
a distal end 367, distal end 367 being an upwardly-facing,
open-ended tip.
[0094] Base portion 361 includes a distal portion 369 and a
proximal portion. Distal portion 369, which is generally tubular in
shape, forms a shoulder with proximal end 365 of stem portion 361.
The proximal portion of base portion 361 is bifurcated into a left
side member 373 and a right side member 375, left side member 373
and right side member 375 being centered relative to the top and
bottom surfaces of distal portion 369 of base portion 361. Wire 105
may be mounted along the top or bottom surfaces of left and right
side members 373 and 375, respectively.
[0095] Referring now to FIGS. 19(a) through 19(c), there are shown
various views of a second alternate needle usable instead of needle
109 in device 101, said second alternate needle being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 379.
[0096] Needle 379 is a unitary structure shaped to include a stem
portion 381 and a base portion 383. Stem portion 381, which is
substantially identical to stem portion 323 of needle 109, is a
generally tubular element shaped to include a proximal end 385 and
a distal end 387, distal end 387 being an upwardly-facing,
open-ended tip.
[0097] Base portion 383 is a generally tubular element shaped to
include a transverse slot 389 extending distally a short distance
from the proximal end of base portion 383. Slot 389, which is
appropriately sized for wire 105 to be mounted therewithin, extends
from the left side of base portion 383 to the right side of base
portion 383 and is centered relative to the top and bottom surfaces
of base portion 383.
[0098] One desirable attribute of needle 379 is that slot 389
permits wire 105 to be coupled to needle 379 in such a way that
wire 105 and needle 379 share a common axis.
[0099] In use, prior to inserting device 101 into a bronchoscope,
an operator typically tests device 101 by using button slide 121 to
alternately position needle 109 in its advanced position and its
retracted position. Once the operability of said needle positioning
mechanism has been confirmed, needle 109 is then locked in its
retracted position by positioning slide 121 so that pawls 207-1 and
207-2 are positioned within notches 169-1 and 169-2, respectively.
The distal end of device 101 is then loaded into a bronchoscope
(which has previously been inserted into the patient to a neutral
location), and a syringe is attached to port 227 of connector 123.
Once confirmation is received that distal end 273 of device 101 has
passed entirely through the bronchoscope (such confirmation
typically being provided using a video channel of the same
bronchoscope), the bronchoscope and device 101 are advanced
together to the target site, and needle 109 is advanced to its
extended position by positioning slide 121 so that pawls 207-1 and
207-2 are positioned within notches 171-1 and 171-2, respectively.
Distal end 335 of needle 109 is then inserted through the bronchial
wall of the patient and into a nearby lymph node. At this time, the
syringe is used to apply suction. In the unfortunate event that
needle 109 has errantly penetrated a blood vessel, instead of a
lymph node, the application of suction causes blood to be aspirated
through bore 337 of needle 109 and into catheter 107 and the
syringe, where such blood is detected. In such a case, the
application of suction is discontinued and the soiled device 101 is
removed from the bronchoscope and the patient. A fresh TBNA device
101 is then loaded into the bronchoscope and the patient in the
manner described above, and another attempt is made to penetrate
the lymph node.
[0100] If, while suction is applied, it appears that needle 109 has
penetrated a lymph node, as is desired, catheter 107 is agitated to
help shear tissue from the penetrated lymph node into bore 337 of
needle 109. With a tissue sample thus disposed within bore 337 of
needle 109, needle 109 is moved back to its retracted position
within catheter 107 by positioning slide 121 so that pawls 207-1
and 207-2 are positioned within notches 169-1 and 169-2,
respectively. Device 101 is then removed from the bronchoscope and
the patient. Needle 109 is then placed in its advanced position by
positioning slide 121 so that pawls 207-1 and 207-2 are positioned
within notches 171-1 and 171-2, respectively, and negative suction
is then used to expel the tissue from needle 109 onto a slide or
the like for histological examination.
[0101] Device 101 is intended to be a single-use device. However,
it is envisioned that, if device 101 is constructed from materials
capable of withstanding reprocessing conditions, e.g., flushing
with suction, followed by (or preceded by) washing in an ultrasonic
bath, flushing again with suction, and then autoclaving, device 101
may be reprocessed for additional use.
[0102] The embodiments of the present invention described above are
intended to be merely exemplary and those skilled in the art shall
be able to make numerous variations and modifications to it without
departing from the spirit of the present invention. All such
variations and modifications are intended to be within the scope of
the present invention as defined in the appended claims.
* * * * *