U.S. patent application number 17/199522 was filed with the patent office on 2021-07-01 for medical tube clearance.
The applicant listed for this patent is CLEARFLOW, INC.. Invention is credited to KENNETH ALLAN BERES, EDWARD M. BOYLE, JR., KENNETH J. CHESNIN, STEPHEN RIDDLE MCDANIEL, KATHRYN BERNADINE O'KEEFE.
Application Number | 20210196924 17/199522 |
Document ID | / |
Family ID | 1000005451372 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210196924 |
Kind Code |
A1 |
O'KEEFE; KATHRYN BERNADINE ;
et al. |
July 1, 2021 |
MEDICAL TUBE CLEARANCE
Abstract
A device for clearing obstructions from a medical tube, such as
a chest tube, is disclosed in various embodiments. In embodiments,
the device features a clearance member that is formed to match a
cross-section of a medical tube. Still further, the clearance
member can have a plurality of branches, each branch configured to
clear a respective lumen in a partitioned region of a medical tube.
In this manner, the clearance member may clear obstructions from
individual lumens of the partitioned region of the medical tube.
Device for actuating a clearance member to clear obstructions
within a medical tube are also disclosed. Methods of clearing a
medical tube of obstructions are also disclosed.
Inventors: |
O'KEEFE; KATHRYN BERNADINE;
(BEND, OR) ; MCDANIEL; STEPHEN RIDDLE; (SAN
FRANCISCO, CA) ; BOYLE, JR.; EDWARD M.; (BEND,
OR) ; BERES; KENNETH ALLAN; (STUDIO CITY, CA)
; CHESNIN; KENNETH J.; (Long Beach, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CLEARFLOW, INC. |
Irvine |
CA |
US |
|
|
Family ID: |
1000005451372 |
Appl. No.: |
17/199522 |
Filed: |
March 12, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14624328 |
Feb 17, 2015 |
10974023 |
|
|
17199522 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0026 20130101;
A61M 1/84 20210501; A61M 2025/0019 20130101; A61M 2210/101
20130101; A61M 2209/10 20130101; A61M 25/00 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 1/00 20060101 A61M001/00 |
Claims
1. A device for clearing obstructions from a medical tube, the
device comprising: (i) an adjustable-length tube connected in fluid
communication with a medical tube, the adjustable-length tube being
elastically stretchable from a relaxed, unstretched state to a
fully elongated, stretched state; (ii) an elongate guide member
extending through the adjustable-length tube and the medical tube,
the guide member being attached at or adjacent to a proximal end
thereof to the adjustable-length tube; and (iii) a clearance member
attached to or formed integrally with the guide member, wherein
extension of the adjustable-length tube results in withdrawal of
the guide member relative to the medical tube, and shrinkage of the
adjustable-length tube back to the relaxed state results in
advancement of the guide member to a resting position within and
adjacent to a distal end of the medical tube.
2. The device of claim 1, the elongate guide member being attached
to the adjustable-length tube via a handle assembly attached
thereto.
3. The device of claim 1, the clearance member having a clearance
element disposed or formed at or adjacent its distal end, the
clearance element being configured to match a cross-sectional
perimeter shape of a lumen in the medical tube.
4. The device of claim 1, the medical tube having an aperture
through a wall of the medical tube adjacent to a distal end
thereof, the clearance member being dimensioned and oriented so
that it cannot pass through the aperture.
5. The device of claim 1, the distal end of the medical tube having
a partitioned region.
6. The device of claim 2, further comprising a thumb grip disposed
on the medical tube at a location distally remote from the handle
assembly, wherein the adjustable-length tube is stretched between
the handle assembly and the thumb grip by separating them
longitudinally relative to the adjustable-length tube.
7. The device of claim 1, wherein a length and elasticity of the
adjustable-length tube are selected so that a difference in its
length between said relaxed state and said fully elongated state
corresponds to a desired maximum degree of withdrawal of the guide
member relative to the distal end of the medical tube.
8. The device of claim 1, the medical tube at least partially
defining a sterile pathway through which obstructions can be
evacuated.
9. The device of claim 1, the adjustable-length tube and the
medical tube together at least partially defining a pathway through
which obstructions can be evacuated.
10. The device of claim 9, the pathway constituting a sterile
field.
11. The device of claim 1, the clearance member being a wire-form
clearance member.
12. The device of claim 1, the adjustable-length tube comprising
coil reinforcement.
13. The device of claim 2, further comprising an intermediate tube
between the handle and the medical tube, the intermediate tube
comprising coil reinforcement.
14. The device of claim 1, further comprising a spring-loaded
drainage canister.
15. The device of claim 1, further comprising a fitting on a distal
end of the adjustable-length tube.
16. A medical tube having a proximal region and a distal region, a
primary lumen extending through both the proximal and distal
regions, and at least one secondary lumen extending in the distal
region and separated from the primary lumen by an interior wall of
the medical tube, the secondary lumen being configured as a channel
substantially open to a space outside the medical tube, the primary
and secondary lumens being in fluid communication via at least one
opening in the interior wall.
17. The medical tube of claim 16, comprising a plurality of
secondary lumens extending in the distal region and separated from
the primary lumen by at least one interior wall of the medical
tube, each of the secondary lumens being configured as a channel
substantially open to a space outside the medical tube, each of the
secondary lumens being in fluid communication with the primary
lumen via at least one respective opening in the at least one
interior wall.
18. The medical tube of claim 17, each of the secondary lumens
being in fluid communication with the primary lumen via a plurality
of openings spaced longitudinally along a length of the at least
one interior wall.
19. The medical tube of claim 16, the primary lumen having a
smaller cross-section in the distal region than in the proximal
region.
20. An assembly comprising the medical tube of claim 16 and a
clearance member received within the primary lumen to clear debris
therein.
21. The assembly of claim 20, the clearance member being a
wire-form clearance member.
22. The assembly of claim 20, the clearance member being made of an
elastic material such that it can adjust to an available
cross-sectional area within the primary lumen at a given
location.
23. The medical tube of claim 16, the primary lumen having a
generally round cross-section.
24. The medical tube of claim 23, wherein the secondary lumen are
arranged circumferentially and forming arcuate channels spaced
apart adjacent an outer circumference of the primary lumen, each of
the secondary lumens being in fluid communication with the primary
lumen via a plurality of openings spaced longitudinally along a
length of the at least one interior wall.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. patent
application Ser. No. 14/624,328 filed Feb. 17, 2015, which claims
benefit of U.S. provisional patent application Ser. No. 61/940,725
filed Feb. 17, 2014, the content of which is incorporated herein by
reference.
BACKGROUND
Field of the Invention
[0002] The invention relates to methods and devices to clear
obstructive debris from medical tubes. More particularly, it
relates to such a device having a clearance member that is formed
to match a cross-section of a medical tube or to clear debris from
multiple lumens in a medical tube.
Description of Related Art
[0003] Millions of medical tubes are used every year to drain
bodily fluids and secretions from within body compartments and
structures. For example, such tubes can be used to drain fluid from
one's bladder, from the colon or other portions of the alimentary
tract, or from the lungs or other organs in conjunction with
various therapies. Medical tubes also are used to drain blood and
other fluids that typically accumulate within the body cavity
following traumatic surgery. In all these cases, a tube is inserted
into the patient so that its terminal end is provided in or
adjacent the space where it is desired to remove accumulated or
pooled fluid and the proximal end remains outside the patient's
body, where it is typically connected to a suction source.
[0004] One of the biggest categories of patients requiring medical
tube drainage is patients who have had heart and lung surgery,
nearly all of whom require at least one chest tube to drain the
space around the heart and lungs after surgery. Chest tubes are
long, usually semi-stiff, plastic tubes that are inserted into the
chest in the vicinity of the heart and lungs to drain collections
of fluids or air from within the pleura, the mediastinum or
pericardial space, or from within the thoracic cavity
generally.
[0005] Fluid and other material accumulating in the vicinity of the
medical tube's distal end (within the patient) is drawn through
that tube and out of the space where it accumulated via suction
applied at the tube's proximal end. Ideally, the medical tube will
remain free from clots and other debris that may partially or
totally obstruct the suction pathway within the medical tube.
Unfortunately, however, bodily secretions (particularly those
including blood or blood platelets) often form clots within medical
tubes, which can partially or totally obstruct the suction pathway
within the tube.
[0006] Obstruction of a medical tube can impact its effectiveness
to remove the fluid and other material for which it was originally
placed, eventually rendering the medical tube partially or totally
non-functional. In some cases, a non-functional tube can have
serious or potentially life-threatening consequences. For example,
if there is a blockage in a chest tube following cardiac or
pulmonary surgery, the resulting accumulation of fluid around the
heart and lungs without adequate drainage can cause serious adverse
events such as pericardial tamponade and pneumothorax. In addition
to chest tubes used in heart, lung, and trauma surgery, other
medical tubes are prone to clogging as well, including feeding
tubes, surgical wound drains, urinary catheters, cardiovascular
catheters, and others.
[0007] There are few effective techniques to manage medical tube
clogging when it occurs. During the perioperative period following
chest surgery or trauma, clinicians will undertake measures to try
to remove any debris (such as a clot) that has accumulated or
formed within the chest tube, to keep the tube clear. One method is
to simply tap the tube to try and break up the debris. Another
method is referred to as "milking the tube." "Milking" involves
using one's fingers, or a rudimentary device composed of a pair of
pliers with rollers fashioned onto its jaws, to compress the tube
over the debris to try and break it up. The goal is to loosen the
debris, or to break it into smaller pieces, so it can be more
readily drawn out of the tube via suction applied at the proximal
end.
[0008] Another technique is fan folding. In this technique, the
clinician bends the chest tube in various ways to try to break up
any long clots or other obstructions that extend along the axis of
the medical tube. The aim is to produce several smaller pieces of
debris, as opposed to one long piece, that will be more readily
drawn proximally via the suction applied at the tube's proximal
end. Still another technique is known as "stripping." Here, the
clinician takes two fingers lubricated in some fashion, or the
improvised device composed of a pair of pliers with rollers
mentioned above, and "strips" the tube. This is achieved by
compressing the tube initially near where it enters the patient,
and drawing the compressing apparatus (one's fingers or other
compression device) proximally, with compression still applied,
along the tube's length toward the suction source. This is done
repeatedly to try and work any obstructive debris out from the tube
and toward the suction source.
[0009] None of the above techniques is particularly effective.
Moreover, they are time consuming and can be quite painful if the
patient is awake and alert when they are performed, due to tugging
on the medical tube. Tugging on chest tubes whose terminal ends
have been placed near the pleura or pericardium can be especially
painful. In addition, the "stripping" technique is known to
generate short bursts of extreme negative pressure within chest
tubes, which in turn draws a strong suction in the body cavity
where its terminal end has been placed. This can be quite dangerous
in certain circumstances. For example, negative pressures of
magnitude greater than -300 cm of water can be generated adjacent
suture lines on coronary anastomosis, etc., which can disrupt some
of the work that was done during a prior surgery. As a result, many
surgeons have banned stripping their patients' chest tubes due to
the potential for complications.
[0010] When the above techniques fail to clear a potentially
dangerous clot within the tube, a more invasive technique must be
used. This requires establishment of a sterile field around the
chest tube, which is disconnected from the suction source to
manually insert a suction catheter to clear the debris. This is
known as open chest tube suctioning, and it can be effective to
clear a clogged chest tube. But it is highly undesirable for a
number of reasons. First, it compromises the sterile field within
the chest tube system by exposing the internal environment within
that system to the external environment, potentially introducing
bacteria inside the chest. Second, the closed system (suction
source to chest tube to body space within the chest) typically must
be breached to insert the catheter inside the chest tube. Breaking
the seal on this system causes loss of the normal physiologic
negative pressure inside the chest. This can result in lung
collapse (pneumothorax) while suctioning the chest tube.
Additionally, the suction catheter can easily be passed beyond the
end of the chest tube, which has the potential to injure the heart
or lungs, which could be life threatening. Finally, this procedure
is time consuming and usually can only be performed by physicians
due to the associated dangers. Thus it is only occasionally done in
extreme situations when a clogged chest tube is causing a serious
acute problem.
[0011] Medical tubes may vary in cross-section along their lengths.
For example, a medical tube may include a single lumen near its
proximal end and be partitioned into a plurality of lumens or
channels at or toward the distal end. Additionally, a medical tube
may have one or more openings and/or apertures that extend through
the medical tube's outer wall to allow fluid to be drawn into the
medical tube from its side. One example tube is partitioned at is
distal end, where a plurality of openings at the distal end of the
medical tube provide communication between one or more of the
partitioned lumens and the space outside the medical tube inside
the patient. To assist the suction typically applied to the medical
tube by a vacuum source, such partitioned medical tubes may help
drain fluid from the patient through capillary action via said
openings. Partitioned medical tubes present a challenge for
clearing obstructions from within the partitioned portion of the
medical tube because a clearance apparatus may not be able to
sufficiently clear each lumen of the medical tube or its
partitioned portion. When a clearance apparatus is inserted into
the medical tube from its proximal end, the clearance apparatus may
not be able to navigate into each separate lumen, which can result
in a clot or occluding material remaining in one or more of the
lumens, thus decreasing the drainage capacity of the medical
tube.
[0012] Currently, surgeons often implant two or more medical tubes,
or employ large-diameter tubes, following surgery to provide
additional drainage capacity and avoid potentially life-threatening
complications of a clogged tube. Methods and apparatus are
desirable to keep medical tubes (partitioned or non-partitioned)
from clogging or to clear them reliably without having to breach
the closed system between the suction source and the body cavity
requiring drainage. Such methods/apparatus may allow surgeons to
place fewer tubes post-surgery, or to select tubes having smaller
diameters, both of which will reduce patient discomfort and
recovery time. Placement of fewer tubes also will minimize the risk
of infection.
SUMMARY
[0013] A device for clearing obstructions from a medical tube is
provided. The device includes an elongate guide member and a
clearance member attached to or formed integrally with the guide
member. The clearance member is a branched clearance member having
a plurality of individual branches each configured to be received
within a respective lumen within the medical tube.
[0014] A further device for clearing obstructions from a
partitioned region of a medical tube is provided. The device
includes an elongate guide member and a clearance member attached
to or formed integrally with the guide member, wherein the
clearance member is formed to substantially match a cross-sectional
perimeter shape of a lumen or lumens in the partitioned region of
the medical tube.
[0015] An apparatus for clearing obstructions from a medical tube
is also provided. The apparatus includes a medical tube coupled to
a handle assembly and an elongate guide member extending at least
partially within the medical tube, wherein at least a portion of
the medical tube is composed of a flexible material adapted to
stretch as the handle assembly is drawn proximally away from a
fixed point along a length of the medical tube.
[0016] A further device for clearing obstructions from a medical
tube is also provided. The device includes an adjustable-length
guide tube connected in fluid communication with a medical tube and
cooperating therewith to at least partially define a pathway
through which obstructions can be evacuated from the medical tube.
An elongate guide member extends through the adjustable-length
guide tube and the medical tube. Extension of the adjustable-length
guide tube results in withdrawal of the guide member relative to
the medical tube, and collapse (i.e. contraction) of the
adjustable-length guide tube results in advancement of the guide
member relative to the medical tube.
[0017] A method of clearing obstructions from individual distinct
lumens in a partitioned region of a medical tube is also provided.
The method includes the following steps: translating an elongate
guide member that is at least partially disposed within the medical
tube, thereby correspondingly translating a clearance member
attached to or formed with the guide member through the medical
tube, wherein the clearance member includes a plurality of
branches, each said branch being received and translating within a
respective one of the distinct lumens.
[0018] An assembly is also provided, which includes a medical tube.
The medical tube has a proximal region and a distal region. A
primary lumen extends through the medical tube in both said
proximal and distal regions thereof. At least one secondary lumen
extends in the distal region of the medical tube and is separated
from the primary lumen by an interior wall of the medical tube. The
secondary lumen is configured as a channel substantially open to a
space outside the medical tube. The primary and secondary lumens
are in fluid communication via at least one opening in the
intermediate wall.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a perspective view of a clearance apparatus
coupled to a medical tube.
[0020] FIG. 2 is a perspective view of a medical tube with openings
(slits in the illustrated embodiment) in the sidewall of the tube
extending along a portion of the length of the tube.
[0021] FIG. 2a is a close-up perspective view of a distal end of
the medical tube of FIG. 2.
[0022] FIGS. 3-5 illustrate medical tubes having variable
cross-sections along their respective lengths.
[0023] FIG. 3 is a side view of an exemplary partitioned medical
tube as described herein.
[0024] FIG. 3a is a cross-sectional view of the medical tube of
FIG. 3 taken along line A-A therein.
[0025] FIG. 3b is a cross-sectional view of the medical tube of
FIG. 3 taken along line B-B therein.
[0026] FIG. 3c is a cross-sectional view of the medical tube of
FIG. 3 taken along line C-C therein.
[0027] FIG. 4 is a side view of another exemplary partitioned
medical tube as described herein.
[0028] FIG. 4a is a cross-sectional view of the medical tube of
FIG. 4 taken along line A-A therein.
[0029] FIG. 4b is a cross-sectional view of the medical tube of
FIG. 4 taken along line B-B therein.
[0030] FIG. 5 is a side view of another exemplary partitioned
medical tube as described herein.
[0031] FIG. 5a is a cross-sectional view of the medical tube of
FIG. 5 taken along line A-A therein.
[0032] FIG. 5b is a cross-sectional view of the medical tube of
FIG. 5 taken along line B-B therein. The distal region
(corresponding to the cross-section in this figure) includes
perforations through the side wall of the medical tube as seen in
FIG. 5.
[0033] FIG. 6 is a perspective view of a partitioned distal region
of a medical tube with apertures in the sidewall thereof along a
portion of its length.
[0034] FIG. 7 is a cross-sectional view of the partitioned region
of the medical tube shown in FIG. 6 taken along line 7-7
therein.
[0035] FIG. 8 is a cross-sectional view of an alternative
embodiment of the medical tube shown in FIG. 6.
[0036] FIG. 9 is a cross-sectional view of a partitioned medical
tube or region thereof according to another embodiment as described
herein.
[0037] FIG. 10 is a cross-sectional view of a partitioned medical
tube or region thereof according to another embodiment as described
herein.
[0038] FIG. 10a is a cross-sectional view of a distal partitioned
region of a medical tube according to yet another embodiment as
described herein, wherein secondary lumens are in the form of
channel U-shaped channels that are fully open to lateral space
exterior to the medical tube.
[0039] FIG. 10b shows a perspective view of the partitioned region
of the medical tube shown in FIG. 10a.
[0040] FIG. 10c shows a longitudinal cross-section of the medical
tube shown in FIG. 10a, wherein the primary lumen undergoes a
convergence in a transitional region between an unpartitioned
region (to the left in the figure) and the partitioned region shown
in FIG. 10a.
[0041] FIG. 11 is a cross-sectional view of a partitioned medical
tube or region thereof according to another embodiment as described
herein.
[0042] FIG. 12 is a cross-sectional view of a partitioned medical
tube or region thereof according to still another embodiment as
described herein.
[0043] FIG. 13 is a cross-sectional view of a partitioned medical
tube or region thereof according to still another embodiment as
described herein.
[0044] FIG. 14 is a cross-sectional view of a partitioned medical
tube or region thereof according to still another embodiment as
described herein.
[0045] FIG. 15 is a cross-sectional view of a partitioned medical
tube or region thereof according to still another embodiment as
described herein.
[0046] FIG. 16 is a cross-sectional view of a partitioned medical
tube or region thereof according to still another embodiment as
described herein.
[0047] FIG. 17 is a side view of a clearance member according to an
embodiment hereafter described.
[0048] FIG. 17a is a rear perspective view of the clearance member
of FIG. 17.
[0049] FIG. 17b is a close up rear perspective view of the distal
end of the clearance member of FIG. 17.
[0050] FIG. 17c is a front view taken from the distal end of the
clearance member of FIG. 17.
[0051] FIG. 18 is a rear perspective view of a clearance member
according to another embodiment hereafter described.
[0052] FIG. 19 is a rear perspective view of a clearance member
according to yet another embodiment hereafter described.
[0053] FIG. 20 is a rear perspective view of a clearance member
according to yet another embodiment hereafter described.
[0054] FIG. 21 is a close up rear perspective view of a distal end
of a clearance member according to yet another embodiment hereafter
described.
[0055] FIG. 22 is a cross-sectional view as in FIG. 8 showing a
multi-branched clearance member disposed within the respective
lumens of the medical tube.
[0056] FIG. 23 is a cross-sectional view as in FIG. 7 showing a
multi-branched a clearance member disposed within the respective
lumens of the medical tube.
[0057] FIG. 24 is a rear perspective view of a clearance member
according to yet another embodiment hereafter described.
[0058] FIG. 25 is a close up rear perspective view of a distal end
of the clearance member of FIG. 24.
[0059] FIG. 26 is a close up rear perspective view of a clearance
member according to yet another embodiment hereafter described.
[0060] FIG. 27 is a close up rear perspective view of a clearance
member according to yet another embodiment hereafter described.
[0061] FIG. 28 is a close up rear perspective view of a clearance
member according to yet another embodiment hereafter described.
[0062] FIG. 29 is a close up rear perspective view of a clearance
member according to yet another embodiment hereafter described.
[0063] FIG. 29a is a close up front perspective view of a clearance
member according to yet another embodiment hereafter described.
[0064] FIG. 29b is a close up front perspective view of a clearance
member according to yet another embodiment hereafter described.
[0065] FIG. 30 is a perspective view of a clearance member
according to still another embodiment hereafter described.
[0066] FIG. 31 is a distal-end view of the partitioned medical tube
of FIG. 9 showing a loop-shaped clearance member disposed within a
primary lumen of the medical tube adjacent its distal end.
[0067] FIG. 32 is a distal-end view of a partitioned medical tube
or distal region thereof according to still another embodiment
showing a loop-shaped clearance member disposed within a primary
lumen of the medical tube adjacent its distal end.
[0068] FIG. 33 is a cross-sectional view of the partitioned medical
tube of FIG. 11 showing a loop-shaped clearance member disposed
within a primary lumen of the medical tube.
[0069] FIG. 34 is a side view of a clearance apparatus coupled to a
medical tube having a partitioned distal region, showing a guide
member and a clearance member advanced within the medical tube,
according to an embodiment hereafter described.
[0070] FIG. 35 is a close-up side view of the distal region of the
medical tube illustrated in FIG. 34, showing a clearance member of
the clearance apparatus having respective branches corresponding to
individual lumens of the partitioned distal region of the medical
tube fully inserted therein.
[0071] FIG. 36 is a close-up side view as in FIG. 35, but with the
clearance member (branches) partially withdrawn.
[0072] FIG. 37 is a close up perspective view of an embodiment of
the thumb grip positioned along the medical tube of the embodiment
illustrated in FIG. 34 as hereafter described.
[0073] FIG. 38 is a close up perspective view of the thumb grip
shown in FIG. 37 with a tab of a restraining element in a
restraining portion of the thumb grip in a resting position.
[0074] FIG. 39 is a perspective view of a clearance apparatus
according to an embodiment hereafter described.
[0075] FIG. 40 is a perspective view of a clearance apparatus
according to another embodiment hereafter described, which has no
separate proximal guide tube. The guide tube shown is in an
expanded configuration.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0076] As used herein, the terms proximal and distal are generally
to be construed with reference to a patient that has been or is to
be fitted with a medical tube, such as a chest tube. For example,
the distal end or region of a medical tube (e.g. chest tube) is
that end or region that is to be inserted into or disposed more
adjacent (e.g. within) the patient during use, as compared to the
opposite end or region of the medical tube (e.g. chest tube).
Similarly, a distal element (or the distal side or region of an
element) is nearer to the patient, or to the distal end of the
chest tube, than a proximal element (or the proximal side or region
of an element). Also herein, the "terminal" end of a tube, wire, or
member refers to its distal end.
[0077] FIG. 1 shows a representation of a clearance apparatus 101
coupled to an exemplary medical tube 102 that is partitioned near
its distal end 104. The medical tube 102 has at least one lumen and
one or more openings 123 in fluid communication with one or more
lumens within the tube 102. In the embodiment of FIG. 1, the
medical tube includes only one lumen. The lumen extends from or
near the distal end 104 to the proximal end 103. The openings 123
extend from at or near the distal end 104 along a portion of the
length of the medical tube 102. In use fluid can be drawn into the
lumen by capillary action or a pressure gradient (e.g. via a
connected vacuum/suction source, vacuum pump, compressed bulb, or
other means). FIGS. 2 and 2a more clearly illustrate the medical
tube 102 with openings 123 along a portion of the length of the
medical tube near its distal end 104. The medical tube 102 can be
attached at its proximal end 103 to a clearance apparatus 101.
Preferably, the medical tube 102 is made from a material having
elastic properties, such as silicone, which will help ensure a
fluid-tight seal. A flexible, elastic medical tube 102, e.g. made
from silicone, also will result in reduced discomfort for the
patient compared to more rigid medical-tube materials, such as
polypropylene or polyethylene. However, if desired these and other
rigid materials may be used. Other materials, including various
thermoplastics and thermosets, also may be used in place of
silicone, if desired. Preferably, the medical tube 102 is made from
a clear (i.e. transparent or substantially transparent) plastic
material, so the operator of the clearance apparatus 101 described
herein can visualize any clot material or other debris therein, as
well as its removal as described below. Aspects and embodiments of
the medical tube 102 hereafter described can be applied directly or
with minor and routine modifications to clear obstructive debris
from a variety of medical tubes used in different applications, for
example chest tubes, catheters, surgical drain tubes to drain fluid
from other structures or orifices, endotracheal tubes, feeding
tubes, gastric tubes, or tubes to deliver material to or from the
alimentary tract, etc.
[0078] Exemplary embodiments of partitioned medical tubes will now
be more fully described. As seen in FIGS. 3-5, medical tubes 102
can be provided that vary in cross-section along their lengths. In
one embodiment illustrated in FIGS. 3-3c, a medical tube 102 having
a generally round or circular perimeter (circumference) can include
a plurality of regions having different cross-sections, each region
having a respective number and arrangement of lumens or channels
therein. The embodiment illustrated in FIGS. 3-3c includes three
distinct regions: a proximal region whose cross-section is shown at
FIG. 3a, an intermediate region whose cross-section is shown at
FIG. 3b, and a distal region whose cross-section is shown at FIG.
3c.
[0079] The proximal region constitutes a single lumen such that
this region is configured as a conventional tube. As shown in FIG.
3a, the medical tube 102 in this region is substantially hollow
having a single lumen of open cylindrical cross-section. As shown
in FIG. 3b the intermediate region is divided into four
substantially equivalent wedge-shaped lumens arranged symmetrically
as shown. As shown in FIG. 3c, in the distal region slits or
apertures are disposed along the length of the tube 102 through its
outer wall so that the wedge-shaped lumens in the intermediate
region give way to correspondingly arranged and similarly-shaped
channels that are open laterally to the space surrounding the tube
102 adjacent the exterior surface thereof, through the
aforementioned slits or apertures. It is to be noted that as used
herein, the term `lumen` includes both enclosed passages, which are
not open laterally to the outside of the medical tube, as well as
channels, which are passages that are open to the outside via
slits, apertures or other openings that provide fluid communication
through the wall of the medical tube. A lumen also can be open to
an adjacent lumen within the medical tube via slits, apertures or
other openings, whether or not it is also open to the outside
through the wall of the medical tube.
[0080] In another embodiment illustrated in FIGS. 4-4b, the medical
tube 102 can be round in shape along a portion of its length near
its proximal end 103 and transition into a flattened shape along a
portion of its length near its distal end 104. This type of medical
tube can be referred to as a flat channel drain. As shown in FIG.
4a taken along line A-A in FIG. 4, a first region of the medical
tube 102 in this embodiment has a single lumen of open cylindrical
cross-section similar to a conventional tube. But as one proceeds
along its length toward the distal end, the medical tube 102 in
this embodiment transitions from that of the first region described
above adjacent the proximal end 103 to a second region adjacent the
distal end 104, which has a flattened, oblong-shaped cross-section
featuring two flat longer sides and two rounded shorter sides. FIG.
4b, taken along line B-B in FIG. 4, shows a cross-section of the
medical tube 102 in this second region wherein the tube is
partitioned into four distinct channels, two of which are
substantially rectangular in cross-section and disposed opposite
one another adjacent the opposed flat sides of the tube, and two of
which are substantially semicircular in cross-section and disposed
opposite one another adjacent the opposed curved sides. In the
illustrated embodiment each of the channels is open to the
environment immediately surrounding the tube via respective slits
or apertures that provide fluid communication through the tube
wall.
[0081] Yet another embodiment is illustrated in FIG. 5, which also
shows a flat channel drain embodiment of a medical tube 102. The
first, proximal region in this embodiment whose cross-section is
shown in FIG. 5a taken along line A-A in FIG. 5, is similar to the
preceding embodiment; i.e. it is a single lumen having a
cylindrical cross-section as in a conventional tube. However,
unlike the preceding embodiment the second region here, whose
cross-section is shown at FIG. 5b taken along line B-B in FIG. 5,
has a single closed lumen whose cross-section is oblong and
substantially ovoid in shape, having flat sides and curved sides
that are parallel to the respective flat and curved outer walls of
the tube in this region. A plurality of longitudinally-extending
ribs are disposed along the length of one flat side of the oblong
lumen in the second region of the medical tube 102 in this
embodiment, defining intermediate channels therebetween. These ribs
may impart a degree of flexural strength to the medical tube 102 in
the second, flat-channel region. They may also aid in maintaining a
channel or channels for fluid flow in the instance where the tube
becomes kinked or crushed.
[0082] FIGS. 6-7 illustrate partitioned medical tube 102 according
to a further embodiment. Specifically, FIG. 6 shows the distal end
of a medical tube 102, which is partitioned into four substantially
equivalent quadrant lumens 105 arranged symmetrically as shown,
each having an arcuate outer wall radially distant from the
longitudinal axis of the tube 102, and a longitudinally-extending
slot 111 opposite the arcuate wall adjacent the axis. As better
seen in FIG. 7, which shows a cross-section taken along line 7-7 in
FIG. 6, the quadrant lumens 105 are separated and defined by
substantially orthogonally, longitudinally-extending radial
cross-members that substantially form a cross or plus sign (+) when
viewed end-on. In this embodiment the slots 111 communicating with
each of the respective lumens 105 are substantially circular in
cross-section. As will be described below, in preferred embodiments
the slots 111 can accommodate respective guide members (e.g. guide
wires) for actuating, as by translation, associated clearance
members within the respective lumens 105.
[0083] FIG. 8 illustrates a cross-section similar to that in FIG. 7
except without the aforementioned slots 111, which may be
undesirable or unuseful in case no guide member/wire is to be
accommodated therein for clearing the respective lumens 105. In a
further alternative (not shown), fewer than all (for example only
one) of the lumens 105 may have associated slots 111.
[0084] In another embodiment illustrated in FIG. 9, a medical tube
102 or portion thereof can include a cross-section with a primary
lumen 112 disposed at the center and coaxial with the central axis
of the tube 102, and a plurality of secondary lumens 105 (which can
be channels open laterally to the outside as illustrated)
positioned about the outer circumference of the primary lumen 112.
In FIG. 9, four secondary lumens 105 are arranged circumferentially
and aligned 90.degree. apart forming essentially arcuate channels
spaced apart adjacent the outer circumference of the primary lumen
112. In FIG. 9 (as well as in FIGS. 6-8) openings 123 penetrate
through the side wall of the medical tube 102 and extend along a
length of the tube 102 at least in the vicinity of the pictured
cross-section; e.g. from at or near the distal end 104. The
openings 123 provide fluid communication between each secondary
lumen 105 and the external environment adjacent the opening. The
embodiment illustrated in FIG. 10 is similar to that of FIG. 9,
with the addition of openings 113 through the wall defining the
primary lumen 112 to provide fluid communication between the
primary lumen 112 and each of the secondary lumens 105.
[0085] FIGS. 10a-10c illustrate a further embodiment of a medical
tube 102 having a partitioned region at the distal end of the tube.
In this embodiment the secondary lumens 105 are configured as
U-shaped channels that are fully open to the space laterally
adjacent and outside the medical tube. In the partitioned region,
each of the secondary lumens 105 is in fluid communication with a
centrally-disposed primary lumen 112 via pluralities of respective
openings 113 spaced longitudinally in the walls separating the
primary lumen 112 from each respective lumen. The partitioned
region is located remote from the proximal end of the medical tube
102. Beginning from a location proximal to the partitioned region,
preferably from the proximal end of the medical tube, the primary
lumen 112 has a cross section greater than that of the primary
lumen 112 in the partitioned region; preferably in this location
the primary lumen 112 is the only lumen in the tube and
consequently can have a maximal cross section suitable for
efficient drainage. As the primary lumen 112 extends distally from
the aforementioned location it reaches a transition region where
its cross section converges from the aforementioned maximal cross
section to a reduced cross section. The convergence of the primary
lumen makes room for secondary lumens 105 to be positioned in the
tube 102 in the partitioned region, for example spaced laterally
about and extending parallel to the primary lumen 112. In this
embodiment, the partitioned region is disposed distally in the
medical tube, preferably adjacent the distal end, and configured to
be implanted within the body cavity or orifice of the patient
requiring drainage. The secondary lumens 105 serve to aid fluid
drainage into the primary lumen 112, which may be connected in-line
with a vacuum source to draw collected fluids and other debris from
the body cavity/orifice. Because only the primary lumen 112 is
fully enclosed about its perimeter it is the primary location where
obstructions are most likely to form. Accordingly, active clearance
of only the primary lumen 112 should be effective to maintain tube
patency. This embodiment avoids multiple relatively small-diameter
lumens, e.g. as in the intermediate region of the medical tube in
FIG. 3, where much of the tube clogging would typically occur.
[0086] In this embodiment the longitudinally-variable primary lumen
112 may be cleared by any appropriately sized clearance member.
More optimal clearance may be achieved using a clearance member 107
that can adjust to the cross section of the primary lumen 112 as it
transitions from the medical tube 102 proximal end 103 to distal
end 114. Clearance members 107 shown in FIGS. 20 and 26-29b can be
manufactured from spring steel or shape memory alloy such as
Nitinol so that lateral compressive forces act on the clearance
member 107 as it advances through a region where the lumen
transitions from larger to smaller cross-section, thereby deforming
the clearance member so that it conforms to an overall smaller
cross-section complementary to that of the smaller-diameter region
of the lumen 112. The clearance members of FIGS. 26-27 utilize
branches or wires that extend laterally and are cantilevered from
the guide member 109 or otherwise from a central portion of the
clearance member. The clearance members of FIG. 28 is a
spiral-wound member, such as a wire, which can be made of elastic
shape-memory material having a resting conformation slightly larger
than the largest cross- section or diameter to which it must
conform in the lumen 112 in use. The clearance members of FIGS.
29-29b are wire-form clearance members, formed of one or a
plurality of shaped wires that are bent or formed so that together
they form an overall three-dimensional structure; for example a
bulb or whisk in FIG. 29, an oblong spheroid in FIG. 29a and an
ellipsoid in FIG. 29b. These wire-form clearance members also are
preferably formed from a shape-memory, elastic material such that
in their resting condition they conform to an overall cross-section
or diameter slightly larger than the largest cross-section or
diameter to which they must conform in use. In each case, the
elasticity of the clearance member allows it to conform to
different cross-sections or diameters of the primary lumen 112, or
at least to adjust to the available cross-section within the lumen
at a given location, to facilitate clearance of different regions.
For example, the clearance member according to any of the
above-described embodiments can conform to the smaller
cross-sectional region of a lumen 112 (e.g. at or adjacent a distal
end of a medical tube 102), and upon withdrawal through the tube
102 into a larger cross-sectional region of the primary lumen 112,
the elastic and/or shape memory properties of the clearance member
will tend to return it to approximately its original shape, such
that it will assume a conformation having a larger overall
cross-section conforming to the larger-diameter region of the lumen
112. By `conform` it is not meant that the cross-section of the
clearance member necessarily matches or is complementary to that of
the lumen 112 (though this is one possible embodiment, particularly
when the lumen has a circular cross-section). Rather, `conform`
simply means that the cross-section of the clearance member expands
to adapt to the available cross-sectional area within the lumen at
a given location.
[0087] In addition to its ability to conform to a variable
cross-section primary lumen 112, clearance members formed of
elastic material as above described also can conform to kinks and
constrictions that may be imparted to the medical tube 102, and to
the primary lumen 112 therein, as a result of bending to conform to
or navigate body structures and organs within the body of a
patient. This feature may prove useful for clearing a medical tube
102 that follows a tortuous path.
[0088] In an alternative embodiment to that illustrated in FIGS.
10a-10c, the primary lumen 112 may have an internal cross-section
that stays consistent from the proximal end of the medical tube to
the distal end of the medical tube. It can be appreciated that in
this configuration the wall thickness in the proximal region that
does not have secondary lumens will become thicker. Alternatively
the overall diameter/cross-section of the medical tube in the
proximal region will be smaller than in the region having secondary
lumens.
[0089] FIG. 11 shows an additional embodiment, wherein the
cross-section of a medical tube or region thereof has three lumens:
a primary lumen 112 having a semi-circular cross-section,
constituting substantially one-half of the total cross-sectional
area of the tube in this region, and two quadrant or secondary
lumens 105 in the form of channels open to the outside constituting
the opposite half of the overall tube cross-section. Openings 123
are positioned along a portion of the exterior wall of the medical
tube 102 adjacent each secondary lumen 105 to provide fluid
communication between each such lumen 105 and the external
environment. Perforations or openings 113 in the wall separating
the primary lumen 112 from each of the secondary lumens 105 provide
fluid communication between each of the secondary lumens 105 and
the primary lumen 112.
[0090] FIGS. 12-16 illustrate further embodiments of medical tubes
102 configured substantially as flat-channel drains. For example,
FIGS. 12-14 show similar embodiments wherein the tube 102 has a
substantially ellipsoid cross-section with a central primary lumen
112 having a substantially circular cross-section concentric with
the longitudinal axis of the tube 102. A pair of secondary lumens
105, each having a substantially trapezoidal-shaped cross-section
with curved walls and being the mirror image of the other, are
arranged on opposite sides of the primary lumen 112. In each of the
illustrated embodiments of FIGS. 12-14, openings 123 in the side
wall of the tube 102 provide fluid communication between each of
the secondary lumens 105 and the exterior environment adjacent the
medical tube 102, such that the secondary lumens 105 are configured
as channels. In the embodiments of FIGS. 13 and 14, openings 113
(e.g. slots or perforations) are provided in the walls separating
the primary lumen 112 from the secondary lumens 105 to provide
fluid communication between them. Pluralities of such openings can
be spaced periodically and longitudinally along the medical tube
102. Alternatively, the openings 113 an be configured as slots that
extend a partial or appreciable length of the medical tube,
preferably at or adjacent its distal end. The embodiment shown in
FIG. 14 includes additional openings 113 in the side wall of the
medical tube between the primary lumen 112 and the external
environment, thus providing fluid communication therebetween.
Again, these openings can be configured and disposed similarly as
described above.
[0091] The embodiment of the medical tube 102 shown in FIG. 15 has
a substantially rectangular cross-section. A substantially
rectangular-shaped primary lumen 112 is centrally positioned in the
tube 102 with a pair of substantially semi-circular shaped disposed
on opposite sides of the primary lumen 112 adjacent the short sides
of the medical tube when viewed in cross-section. Each
semi-circular shaped lumen 105 can be provided with fluid
communication with the exterior environment outside the tube via
openings 123 in the side wall of the tube, for example in the
vicinity of its distal end that would be inserted within a patient
cavity during use, in order to drain fluids present in that
vicinity. Also as before, internal openings 113 can be provided in
the walls separating the primary lumen 112 and each secondary lumen
105. Still further, additional openings 113 can be provided in the
long-side walls of the tube 102 to provide communication between
the primary lumen 112 and the external environment. Such openings
113 and 123 can be disposed and configured in the tube of this
embodiment similarly as already described.
[0092] Each of the aforementioned medical tubes has possessed a
symmetric cross-section such that the left side is a mirror image
of the right side when viewed in cross-section. However, asymmetric
tubes (when viewed in cross-section) are also within the scope of
this disclosure. In one alternative embodiment shown in FIG. 16, an
ovoid-shaped medical tube 102 can include, e.g., a circular-shaped
primary lumen 112 offset from the center of the medical tube so
that its axis is not the same as the central axis of the medical
tube. A substantially oval-shaped secondary lumen 105 is positioned
adjacent the opposite rounded side-wall of the medical tube 102 in
the illustrated embodiment, wherein an opening 123 in the side wall
of the tube 102 provides fluid communication between the external
environment and the lumen 105. Additionally, openings 113 in the
outer walls of the tube 102 adjacent the primary lumen 112, as well
as in the interior wall separating the two lumens, provide fluid
communication between the secondary lumen 105, the primary lumen
112 and the external environment. Again, these openings 113 and 123
can be disposed and configured as already described.
[0093] Regardless of the relative positioning and orientation of
the plurality of distinct lumens running parallel within a medical
tube or within a region of a medical tube, a multi-branched
clearance member can be configured to match the lumen configuration
in order to provide simultaneous clearance of the plurality of
lumens. Returning for example to the multi-lumen configurations
illustrated in FIGS. 7 and 8, a multi-branch clearance member, e.g.
as illustrated in FIGS. 17-17c can be configured to provide
respective clearance elements corresponding to and aligned with
each of the respective lumens in order to provide effective and
simultaneous clearance of each. The clearance member 107 (FIG. 17)
can be provided, for example, at or formed as part of the distal
end of an elongate guide member 119 that can be actuated from a
more proximate location relative to the patient. Any suitable
actuation mechanism effective to translate or otherwise actuate the
clearance member 107 in or through the correspondingly and
respectively arranged lumens for clearance thereof can be used. One
exemplary actuation device is disclosed, for example, in U.S. Pat.
No. 7,951,243, which is incorporated by reference. However, other
suitable actuation mechanisms may be advantageously used.
[0094] Returning to the embodiment of FIGS. 17-17c, the clearance
member 107 is disposed at and in a preferred embodiment integrally
formed with or as the distal end of an elongate guide member 119,
which can be reversibly advanced into and through the medical tube
102 to break up and/or withdraw obstructive debris therefrom (also
described below). In one embodiment, the guide member 119 can be in
the form of a guide wire, and the clearance member 107 can be
formed by the guide wire, or by a plurality of wires that are
intertwined to provide the guide member 119 but which are unwound
and separated to provide distinct branches 109 of the clearance
member 107 as hereafter described. In the illustrated embodiment,
the clearance member 107 is configured for use in a medical tube
102 that is partitioned into a plurality of lumens 105 configured
substantially as illustrated in the cross-sections of FIG. 7 or 8,
at least at or adjacent the tube's distal end 104.
[0095] Referring now to FIG. 17, the exemplary multi-branched
clearance member 107 has a plurality of wires that are bundled
together at a proximal end 110 where it meets (or transitions from)
the guide member 119. The individual wires can be intertwined,
twisted, wound into a helix or parallel to one another. In an
alternative embodiment, the wires may be bundled at their proximal
end 110 by a retaining member that holds the wires together, or
they may be welded together. In one of the aforementioned
configurations the bundled wires may form the guide member 119
itself. The individual wires are separated into four distinct
branches 109 on approach of the distal end 108 of the clearance
member 107, each constituting a respective clearance element
aligned and adapted to clear an associated one of the lumens in the
medical tube 102. That is, the wires are separated such that the
resulting branches 109 are spatially arranged to fit within the
lumens of a complementarily-partitioned medical tube 102. As seen
in FIGS. 17a-17c, in the illustrated embodiment the terminal end of
each individual wire/branch 109 is wound to form a loop 107a. The
diameter of each loop 107a can be selected, for example, to
substantially correspond to the circumference of the inner wall of
a corresponding lumen 105 of the medical tube 102 to which the
clearance member 107 will be fitted, as described in more detail
below. Other configurations besides loops are also contemplated to
match the cross-sectional perimeter shape of the lumens to be
cleared, as will also be described below. The length of the
clearance member 107 is preferably dimensioned to correspond to a
length of a partitioned region of the medical tube 102 to allow the
clearance member 107 to break up and/or withdraw debris from within
the partitioned portion of the medical tube 102, for example upon
translation from a fully-advanced state within the aforesaid
partitioned region to a substantially fully withdrawn state
relative to said region.
[0096] In a further embodiment, the terminal end of each individual
wire branch 109 of the clearance member 107 can include a sphere
107b as shown in FIG. 18. The diameter of each sphere 107b again is
preferably selected to provide a sphere whose cross-sectional
dimension substantially corresponds to that of the lumen 105 of the
medical tube 102 in which it will be actuated to clear debris. The
embodiment of FIG. 18 also illustrates bundling the wires of the
clearance member 107 at their proximal end 110 by twisting the
wires together with a single-wire guide member 119.
[0097] Similar to FIG. 18, FIG. 19 illustrates an embodiment with
spheres 107b disposed or formed at the terminal ends of the
branches 109 of the clearance member 107. As compared to the
embodiments in FIGS. 17 and 18, the individual wires of the
embodiment of FIG. 19 are arranged farther apart from each other,
as would be appropriate in case of a medical tube having a
corresponding and complementary multi-lumen configuration. In this
embodiment the lengths of the branches 109 of the clearance member
107 are also shorter than in earlier-illustrated embodiments, which
would correspond to a similarly-shorter multi-lumen region of a
medical tube 102 in which the clearance member 107 is to be
effective to clear debris. It will be appreciated that the number,
arrangement, spacing and length of the branches 109 of a
multi-branch clearance member 107 as herein described can be
selected to correspond to the complementary features in the
multi-lumen region of the medical tube 102 to be cleared.
Additionally, FIG. 19 shows an embodiment where the wires forming
the branches 109 are bundled at the proximal end 110 of the
clearance member 107 by a retaining member 127 that holds the wires
together.
[0098] In the embodiments of FIGS. 17-19, the wires of the
clearance member 107 are arranged to correspond with particular
lumens of a partitioned medical tube 102. FIG. 20 illustrates
another embodiment of a clearance member 107 comprising a plurality
of branches 109 that are bundled together at their proximal end 110
by a retaining member 127, but which radiate away from one another
and away from a central axis of the clearance member 107. In this
embodiment, the branches 107 are made of a flexible, preferably
shape-memory material so that they retain a degree of rigidity and
stiffness, yet can be bent to follow the contour of a particular
lumen upon being forcibly advanced therein. Configured in this
manner, the individual branches 107 are not arranged to correspond
to complementarily arranged lumens 105. Instead, upon advancement
toward and into a multi-lumen region of a medical tube 102
respective ones of the branches 107 will encounter and enter
respective lumens, and upon further advancement will be forcibly
conformed to follow the paths defined by those lumens. Upon
continued advancement and subsequent retraction into/from those
lumens, or alternatively upon other actuation such as vibration,
sonication, etc., each branch 107 can effectively clear a
respective lumen 105.
[0099] FIG. 21 shows another exemplary embodiment of a clearance
member 107 for a partitioned flat-channel drain, this one
configured to clear the lumens within the medical tube
configuration illustrated in FIG. 15. In this embodiment, the
terminal ends of the branches 109 aligned to clear the secondary
channels 105 in FIG. 15 are configured as loops 107a, which can
approximate the perimeters of the respective channels 105 in
cross-section. Capsules 107c are at the terminal ends of the
branches that are arranged to be inserted into primary lumen 112 in
FIG. 15. As will now be appreciated, multiple branches 109 and
their associated clearance elements at their distal ends (if
present) can be configured and arranged to jointly enter and clear
a common lumen. Alternatively, the clearance member 107 of this
embodiment could be utilized to clear a four-lumen medical tube
102, such as for example the one illustrated in FIG. 4. In this
embodiment, the branches 109 having the capsule 107c clearance
elements would be aligned and utilized to enter and clear the two
rectangular-shaped lumens on the longer sides of the medical tube
102 in FIG. 4, while the other two branches 109 having the loops
107a would be aligned and utilized to enter and clear the two
semicircular-shaped lumens adjacent the shorter sides of the
medical tube 102. The dimensions of each loop 107a and capsule 107c
are preferably selected to substantially correspond to the
dimensions of the inner wall of a lumen 105 of the medical tube 102
to which the clearance member 107 will be fitted. It can be
appreciated that for clearance of the lumen configuration of FIG.
15 a clearance member with fewer clearance elements of appropriate
shape may be used.
[0100] FIGS. 22 and 23 show cross-sections of the partitioned
medical tubes of FIGS. 8 and 7, respectively, wherein the clearance
member 107 of FIG. 17 has been inserted such that its respective
branches 109 extend into the correspondingly-arranged lumens 105.
As discussed above, each loop 107a is preferably selected to
substantially correspond to the circumference or other lateral
dimension(s) of the inner wall of the associated lumen 105. Each
loop 107a also provides a substantially unobstructed pathway
through each lumen 105 where the loop is located regardless whether
the clearance member 107 (and accordingly the loop 107a) is at rest
or being actuated to clear debris within the lumen 105.
Additionally, in the embodiment of FIG. 23 the guide member 119 is
received within and extends through the slot 111 associated with
each of the lumens 105 within the tube 102. This arrangement helps
guide translation of the clearance member 107 and its associated
branches 109 through the respective lumens in the multi-lumen
region of the tube.
[0101] When actuating the multi-branched clearance member 107, it
is preferably not retracted so far that the branches 109 thereof
become entirely withdrawn from their respective lumens 105. This is
because realignment and insertion of the branches 109 within the
respective lumens 105 will be difficult and perhaps impossible in
clinical situations where the tube 102 is inserted within a patient
and visualization of the multi-lumen region within the tube may be
impossible or obscured. Alternatively, even if the multi-lumen
region can be visualized it could be difficult to realign all
branches 109 with their associated lumens 105 for reinsertion. For
example, FIGS. 35-36 (discussed in more detail below) illustrate
side views of a multi-branch clearance device 107 as discussed
above with respect to FIGS. 22-23 at different stages of
advancement within a distal, multi-lumen region of a medical tube
102. In FIG. 35 the clearance member 107 is fully inserted so that
its branches 109 penetrate to near the distal end of the individual
lumens; whereas in FIG. 36 the clearance member 107 has been
withdrawn so that the branches 109 are nearly but not quite fully
withdrawn from the multi-lumen region. It is desired not to
withdraw the multi-branched clearance member 107 to a greater
extent than illustrated in FIG. 36; i.e. to such an extent that the
branches 109 would be entirely withdrawn from their associated
lumens in the multi-lumen region of the medical tube 102.
[0102] The embodiments illustrated in FIGS. 24 and 25 illustrate an
embodiment of a clearance member 107 for use in a flat channel
drain that includes regions with different cross-sections, for
example, as illustrated in FIG. 5. In this embodiment, the terminal
portion of the guide member 119 is wound to form an oblong-shaped
loop 107d at its distal end. The loop 107d is shaped to correspond
to the perimeter dimensions of the distal region of the medical
tube shown in FIG. 5, and would be effective to clear debris
therein. Separately, a second, circular clearance member 124 is
positioned more proximally and attached along the guide member 119.
The clearance member 124 is shaped to correspond to the perimeter
dimension of the proximal region of the medical tube in FIG. 5, and
would be effective to clear debris in that region. As will be
appreciated, actuation of the guide member 119 from a proximal
location will simultaneously actuate (e.g. translate, sonicate,
vibrate, etc.) both the clearance members 107 and 124 in this
embodiment, thus simultaneously clearing two longitudinally
distinct regions of the medical tube, each having its own
respective cross-section. It is to be noted that while the
clearance member 107 in this embodiment is configured as a loop for
a single-lumen distal region having oblong cross-section, the
clearance member 107 also could be a multi-branched member as above
described for clearing a multi-lumen region of the medical tube.
Moreover, the loops illustrated in FIG. 24 are exemplary and
correspond to the particular proximal and distal regions of the
medical tube in FIG. 5. But it is to be appreciated that the loops
can possess any suitable shape and may be arranged at suitable
spacings to correspond to the particular medical tube to be
cleared. Additionally, multiple clearance members, two or more, may
be used in each longitudinally distinct region to achieve clearance
along the length of the region using a given actuation.
[0103] FIGS. 26-29 illustrate additional embodiments of clearance
members 107 that are configured to be insertable into a lumen of a
medical tube 102, such as the primary lumen 112 shown in FIGS.
9-16. For example, the embodiment of FIG. 26 utilizes a wound
spiral guide member 119. Groupings of wires or bristles 125 can
extend laterally from between adjacent turnings of the guide member
119 and are preferably angled toward the proximal end of the guide
member 119 to provide a wire-brush type cleaning member 107. In an
alternative embodiment, rows of scraper elements 128 can be
arranged around the circumference of a guide member at a distal end
108 of a clearance member 107 as shown in FIG. 27. In the
illustrated embodiment, each row of scraper elements 128 includes
three wires that extend laterally from the guide member 119 and
form a hook at their terminal end. Each wire is angled toward the
proximal end of the guide member 119. In another embodiment, a
guide member 119 can be wound turning about an axis at a constant
upward angle to form a helix-shaped clearance member body 109 as
shown in FIG. 28. The terminal end of the wound guide member 119
can be capped with a sphere 107e to form a blunt end. In a further
embodiment, FIG. 29 illustrates a clearance member 107 comprising a
plurality of wire loops that are bundled and held together by a
retaining member 127 to form a whisk shape at a distal end 108 of
the clearance member 107. In a further alternative embodiment, the
clearance member 107 as shown in FIG. 30 comprising a sphere 107e
at a terminal end of a guide member 119. The sphere 107e may be
sized to approximate the internal diameter of a round lumen. It may
be sized substantially close to the lumen diameter, but with some
clearance for the passage of fluid to prevent altering pressure
within the target drainage compartment (e.g. the body orifice or
cavity being drained), by a plunger effect. Alternately, it may be
size larger than the diameter provided the wall of the lumen is
made from an elastic material such as silicone, thereby scraping
the walls of the lumen while simultaneously stretching them to
loosen material. Alternatively, it may be sized substantially
smaller than the lumen to allow free flow of fluid and material
past the sphere. In an alternative embodiment, the distal end of
the clearance member 107 can be in the form of a loop as generally
discussed in U.S. Pat. No. 7,951,243, herein incorporated by
reference in its entirety. A clearance member 107 configured as any
one of the above, or having any alternative suitable configuration,
can be provided in place of the oblong loop 107d in the embodiment
shown in FIG. 24 so long as it is appropriate to clear the
associated distal region of a medical tube 102.
[0104] Alternatively or in addition, the clearance member 107 of
each of the embodiments of FIGS. 26-30 can be configured to be
insertable into a primary lumen 112 of a multi-lumen medical tube
102 or of a multi-lumen region of a medical tube 102, without
necessarily requiring additional branches 109 to be insertable or
inserted in adjacent lumens. For example, FIG. 31 shows the
partitioned medical tube of FIG. 9 with a loop-shaped clearance
member 107 within the primary lumen 112. The clearance member 107
is preferably selected to substantially correspond to the perimeter
dimensions (in this case the circumference) of the inner wall of
the lumen 112. FIGS. 32 and 33 show additional examples of
partitioned medical tubes 102 with a loop-shaped clearance member
107 within the primary lumen 112. Notably, no clearance members or
branches 109 are provided to clear the secondary lumens 109 in
these embodiments. While the clearance member 107 embodiments
illustrated in FIGS. 31-33 provide a substantially unobstructed
pathway through the lumens 112, alternative clearance member
embodiments may obstruct more of the pathway through the lumens
112. It can be appreciated that multiple clearance members of the
same or differing configuration can be deployed along the length of
the lumen.
[0105] The guide member 119 and clearance member 107 can be made
from conventional materials including plastics and metals. It is
preferred that the guide member 119 be made from a material having
sufficient flexibility that it can reversibly bend to a radius of
curvature of four centimeters, more preferably three centimeters,
more preferably two centimeters or one centimeter, without snapping
or substantially compromising its structural integrity. Suitable
materials include, stainless steel, titanium-nickel (such as
Nitinol), cobalt alloys. In addition to being sufficiently flexible
to negotiate bends in the medical tube 102 on being
advanced/retracted therethrough, the guide member 119 should
preferably have sufficient stiffness or rigidity to be pushed
through accumulated clot material within either tube without
kinking or being caused to double back on itself. The guide member
119 may be coated with a friction-reducing material or non-stick
material, for example PTFE, FEP, parylene, or silicone, in order to
inhibit the adherence of clot material, thrombi or other
obstructive debris, thus promoting better lumen clearance. The
guide member 119 may be coated with a pharmacologic material. The
guide member 119 may be coated with an anti-thrombogenic material.
The guide member 119 may be coated with an anti-infective material.
Alternatively, the guide member 119 may be coated with a
combination of these. The guide member 119 also can have a guide
lumen provided in fluid communication with one or more openings
disposed through the wall of the clearance member 107 or with any
or all of its individual branches 109 (not shown) as generally
discussed in U.S. Pat. No. 7,951,243, which has already been
incorporated by reference. The guide lumen and cooperating openings
may be utilized to deliver flushing or irrigation fluid to assist
in dislodging any material stuck to the clearance member 107 or its
branches 109. In addition or alternatively, fluid expelled from the
guide lumen through the one or more openings may be a solution
provided to assist in the dislodgment, dissolution, and/or breakup
of the debris. Fluids suitable for the particular purpose include,
but are not limited to, anti-thrombolytic agents, Alkalol.TM.,
among others. In still other embodiments, such fluid may be or
include a therapeutic agent such as but are not limited to
antibiotic agents, anti-infective agents, anti-neoplastic agents,
and other agents for a variety of purposes, including pain relief,
treatment of infection, cancer, or to induce scarring (i.e.
pleurodesis). Alternatively to delivering fluids, the guide lumen
may be used to detect carbon dioxide in a patient's chest cavity as
a means to determine whether there is a puncture in the patient's
lung as generally discussed in the '243 patent.
[0106] As previously discussed, the clearance member 107 may be
attached to or formed at the distal end of a guide member 119 that
can be actuated from a proximal end of the medical tube; e.g. from
outside the medical tube at or adjacent its proximal end. One
embodiment of an actuation device is disclosed in the '243 patent
incorporated above. Briefly, as disclosed in that patent a medical
tube such as a chest tube can be connected at its proximal end to a
shuttle-guide tube, and a shuttle translatable along the length of
the guide tube can be magnetically coupled to a magnetic guide
disposed within the guide tube. The magnetic guide is itself
coupled to a proximal end (or in a proximal region) of the guide
member such that translation of the shuttle along the guide tube
length outside that tube induces a corresponding translation of the
guide member within. Translation of the magnetic guide results in
translation of the attached guide member and correspondingly of any
clearance member at or adjacent its distal end to clear obstructive
debris within the medical tube.
[0107] FIGS. 34-40 illustrate further embodiments of a device for
actuating the guide member 119, and correspondingly clearance
member 107, to clear obstructive debris in medical tubes according
to any of the preceding embodiments. For example, referring first
to FIG. 34, an actuation device includes a handle assembly 114 that
is effective to translate the guide member 119, and therefore the
clearance member 107, within the medical tube 102, e.g. a chest
tube. In this embodiment the medical tube 102 can be coupled to the
handle assembly 114 via a medical-tube fitting 115, which
preferably has an internal diameter that is in continuity with the
medical tube 102 at least at the point of attachment. The handle
assembly 114 can also be connected to a vacuum drainage tube or
other suction source (not shown) through a suction fitting 116
disposed at the proximal end of the handle assembly 114. The handle
assembly 114 itself is substantially hollow or otherwise defines
therein a conduit or passageway between the proximal and distal
ends (i.e. between medical-tube and suction fittings 115 and 116,
so that debris evacuated from the medical tube 102 can be drawn
through the handle assembly 114 via a suction source. A guide
member 119, e.g. according to any of the embodiments above
described, is secured to or within the handle assembly 114 at or
adjacent the member's 119 proximal end.
[0108] The length of the guide member 119 may be calibrated to
ensure that the clearance member 107 at its distal end 108 does not
extend out of or beyond the distal end 104 of the medical tube 102.
For example, the length of the guide member 119 and its clearance
member 107 together preferably substantially approximate the
distance from the guide member's point of attachment with the
handle assembly to just short of the distal end of the medical tube
102.
[0109] In this embodiment the medical tube 102 or at least a
proximal portion thereof near or adjacent the handle assembly 114
is made of a flexible material that is elastically stretchable,
such as a suitable elastomer or silicone. The medical tube 102 may
be reinforced in this area for e.g. by coil reinforcement or other
means such as braiding using metal or polymer wires or strands, to
resist breakage and enhance elastic recoil. Alternatively, an
intermediate, elastically stretchable tube can be interposed and
connected in fluid communication between the handle member 114 and
the medical tube 102 via suitable fittings (not shown). The
intermediate tube may also be reinforced similarly as described
above. In either case, preferably a thumb grip 117 is disposed on
the outside of the medical tube 102 (or optionally on the
aforementioned intermediate stretchable tube if present) at a
location distally remote from the handle assembly 114.
[0110] In order to clear obstructing material from the medical tube
102, a user would grasp the medical tube 102 (or intermediate tube
if present) at a position distal from the handle assembly 114, e.g.
at the thumb grip 117, simultaneously grasp the handle assembly
114, and draw the handle assembly 114 proximally away from where
the tube is being grasped with the other hand. As the effective
length of the tubing between the handle assembly 114 and the distal
end 104 of the medical tube 102 is increased when the medical (or
intermediate) tube is stretched, a normally in-dwelling clearance
member 107 (i.e. one that normally rests within the medical tube
adjacent its distal end) will be drawn proximally through the
medical tube. The clearance member 107 can thus clear debris in the
lumen(s) served by the clearance member 107 or its branches 109 (if
present) by drawing obstructive debris proximally, toward the
handle assembly 114. While continuing to hold thumb grip 117 with
one hand, the user can return handle assembly 114 back to its
original location and the elastic portion of the medical tube 102
between thumb grip 117 and handle assembly 114 will shrink back to
its original length, advancing the guide member 119 and clearance
member 107 back to their original resting position. During this
operation, care should be taken not to stretch the medical tube 102
(or its elastic portion) so far that the clearance member 107
becomes completely withdrawn from the partitioned region of the
medical tube. This is because reinsertion of individual wires of
the clearance member 107 into respective lumens in the partitioned
region may be difficult as noted above. The user can repeat these
steps to translate the clearance member 107 through the partitioned
region of the medical tube 102, or a portion thereof, in order to
dislodge blood, clots, and other debris that may have accumulated
along the inner walls of the lumens in the partitioned medical
tube. Loosened blood, clots, and other debris then can drain from
the medical tube 102 through the fitting 115 into the handle
assembly 114, and then through the fitting 116 to the vacuum
drainage tubing and into a drainage receptacle (not shown). Suction
is generally applied to the drainage receptacle to facilitate the
drainage along this pathway.
[0111] FIG. 35 illustrates an exemplary multi-branch clearance
member 107 having a plurality of branches 109 disposed in
corresponding lumens within a multi-lumen distal region of a
medical tube 102. Utilizing the stretchable tube/region feature
described above, upon expanding the effective length of the tube
the clearance member will be withdrawn from its resting position
adjacent the distal end 108 of the medical tube, to a more proximal
position relative to the distal end 108 as shown in FIG. 36.
According to a preferred embodiment, the elasticity and length of
the stretchable region/tube can be selected together so that the
difference in its length between its relaxed state and
fully-stretched state corresponds to the desired maximum degree of
withdrawal of the clearance member 107 relative to the distal end
of the medical tube 108. In this manner, for example, a
multi-branched clearance member 107 can be assured not to be
withdrawn entirely from the multi-lumen region of a medical tube
102 if the aforementioned length difference corresponds to or is
just under the length of the multi-lumen region. In an alternative
embodiment the multi-branch clearance member may be positioned in
the tube so that it traverses only a portion of the partitioned
region (having multiple lumens) in the medical tube when actuated.
For example the distal end of the clearance member (i.e. of
branches 109) may only traverse the distal and intermediate regions
of the medical tube shown in FIG. 3 (corresponding to the
cross-sections taken along lines A-A and B-B therein). Optionally
they may be withdrawn only partially into the proximal region
corresponding to the cross-section taken along line C-C. When the
tube is stretched the clearance member clears the intermediate
region, which is the most likely region for tube clogging to occur
in the configuration shown in FIG. 3.
[0112] In an alternative embodiment, a stretch-limiting mechanism
can be incorporated to impede unintended complete withdrawal of the
clearance member 107 from the partitioned region of the medical
tube 102 if the medical tube 102 is stretched too far as mentioned
above. FIG. 37 shows an embodiment of a clearance apparatus 101
similar to that of FIG. 34 wherein the thumb grip 117 is equipped
with a stretch restraint portion 126. A distal end of the thumb
grip 117 has an internal diameter that substantially corresponds to
the outer diameter of the medical tube 102, thereby enabling
securement of the grip 117, and correspondingly the restraint
portion 126, to the medical tube 102 via an interference fit or via
any other suitable mode of attachment; e.g. use of an adhesive. The
medical tube 102 passes through a cylindrical passage in the
stretch restraint portion 126 of the thumb grip 117 from its distal
end, and continues to the handle assembly 114, where the medical
tube 102 is coupled to the handle assembly 114. As shown in FIG.
38, a restraining element such as a ring 131 is housed within the
restraint portion 126, and is slidably translatable therethrough
along a longitudinal axis of the medical tube 102 that passes
centrally through the center of the ring 131. The ring 131 has an
internal diameter that substantially corresponds to, or that is
even slightly smaller than, the outer diameter of the medical tube
102, thereby securing the ring 131 in place on the tube 102 via an
interference fit. Alternatively or in addition, adhesives may also
be used, for example when the restraining element is not configured
as a ring that receives the tube 102 therethrough but is instead
merely adhered to the surface of the tube 102. The ring 131 has an
outer diameter substantially matching the inner diameter of the
cylindrical passage within the stretch restraint portion of the
thumb grip 117 for ease of alignment and translation therein. A tab
or slide switch 132 is formed with or attached to an upper portion
of the ring 131 and extends through a slot 130 provided in the
housing of the restraint portion 126, aligned with its longitudinal
axis. In its resting (unengaged) position, such as when the medical
tube 102 or its elastically stretchable region is relaxed and
unstretched, the restraining ring 131 is located near the distal
end of the restraint portion 126, wherein the tab/switch 132 is
disposed at the distal-most part of the slot 130. In its engaged
position, the restraining ring 131 is located near the proximal end
of the restraint portion 126, wherein the tab 132 is reaches and is
engaged against the proximal-most part of the slot 130.
[0113] In use, as the medical tube 102 (or its elastic region) is
stretched from the distally-located thumb grip 117 (as by
separating the grip 117 and handle assembly 114), the tab 132 of
the restraining ring 131, which is fixed on the medical tube, will
approach and reach the proximal end of the slot 130. When the tab
132 reaches this point it will inhibit further stretching of the
medical tube 114 thus inhibiting the clearance member 107 from
being withdrawn from a partitioned region of the medical tube 102.
At a minimum, the progression of the tab 132 toward the proximal
end of slot 130 in use can serve as an indicator to the operator
how far the tube has been stretched and, optionally, when to cease
further stretching. In this embodiment, for example, the length of
the slot could be calibrated to the length of a multi-lumen region
of the medical tube 102 from which it is desired to prevent
complete withdrawal of a clearance member 107 at the end of the
guide member 119 within the tube. It can be appreciated that other
mechanical means can be used to limit the stroke of the clearance
member and prevent over stretching. In yet another embodiment, the
clearance apparatus 101 may include one or a plurality of
adjustable-length guide tubes coupled to or formed as part of the
handle assembly 114 for the clearance apparatus 101, through which
debris evacuated from the medical tube 102 may flow on its way to a
suction source. Such adjustable-length guide tube(s) can be
coupled, for example, in-line with and proximal to the medical tube
with the guide member 119 extending at least partially therein, so
that expansion and contraction of the adjustable-length guide tube
can accommodate cycles of actuation (e.g. advancement and
withdrawal) of the guide member 119 as already described. FIGS. 39
and 40 illustrate exemplary embodiments of handle assemblies 114 of
clearance apparatus 101 having adjustable-length guide tubes
associated therewith, in which the guide tubes are configured as
accordion-style collapsible tubes.
[0114] Referring first to FIG. 39, a handle assembly 114 distal and
proximal handle portions 120 and 121 that are longitudinally
separable from one another. The handle portions 120 and 121 are
connected via a proximal adjustable guide tube 122b that defines a
substantially cylindrical and variable-length passageway therein,
which in use will cooperate to partially define the sterile pathway
between a medical tube and a suction source. As will be appreciated
from FIG. 39, as the handle portions 120 and 121 are separated
adjacent accordion elements in the tube 122b wall will unfold, thus
lengthening the guide tube 122b. Conversely, as the handle portions
120 and 121 are brought together and ultimately attached to one
another, the accordion elements will fold, thus collapsing the
length of the tube 122b. The handle portions 120 and 121 can have
respective and facing parking surfaces that cooperatively engage
one another when the portions 120 and 121 are assembled to complete
the handle assembly 114. For example, detent tabs, magnets or other
reversible coupling structure can be used to secure the handle
elements together when not in use.
[0115] A guide member 119 as above described can be disposed within
the handle assembly 114, and be secured at its proximal end to the
proximal handle element 121. In this manner, as the length of the
adjustable guide tube 122b is increased by separating handle
portions 120 and 121, a clearance member 107 at the distal end of
the guide member 119 can be withdrawn from within a medical tube
102 as above described. Conversely, collapsing the guide tube 122b
will advance the guide member 119 attached to the handle element
121 through the medical tube 102, e.g. to restore it to a resting
or parked position adjacent the medical-tube distal end 108.
[0116] In addition to or instead of the proximal adjustable guide
tube 122b, the clearance apparatus 101 can include a distal
adjustable guide tube 122a as seen in FIG. 39. In the illustrated
embodiment the distal adjustable guide tube 122a has accordion
elements similarly as described above, and can be expanded and
collapsed lengthwise in a similar manner; i.e. by adjusting the
distance between the handle assembly 114 (or at least of the distal
handle portion 120, and a fixed point along the length of the guide
tube 122a, for example a fitting 115 for securing the distal end of
the guide tube 122a to distal structure, such as a medical tube
102. Again, with the proximal end of the guide member 119 secured
to the proximal handle portion 121, expansion of the distal guide
tube 122a will result in withdrawal of the guide member and
clearance member from the medical tube, whereas contraction of the
guide tube 122a will result in advancement. Alternatively, and
particularly when the proximal guide tube 122b is omitted as seen
in FIG. 40, the proximal end of the guide member 119 can be secured
within the distal handle portion 120; or in the handle assembly 114
if not separated into portions 120 and 121 case. In an alternative
embodiment, the guide member 119 may be actuated via a spool-drive
mechanism as described in co-pending non-provisional patent
application Ser. No. 14/624,161 filed on even date herewith, herein
incorporated by reference in its entirety.
[0117] Although the invention has been described with respect to
certain preferred embodiments, it is to be understood that the
invention is not limited by the embodiments herein disclosed, which
are exemplary and not limiting in nature, but is to include all
modifications and adaptations thereto as would occur to the person
having ordinary skill in the art upon reviewing the present
disclosure, and as fall within the spirit and the scope of the
invention as set forth in the appended claims.
* * * * *