U.S. patent application number 14/213795 was filed with the patent office on 2014-09-18 for aspiration catheters, systems, and methods.
This patent application is currently assigned to Patient Centered Medical Incorporated. The applicant listed for this patent is Patient Centered Medical Incorporated. Invention is credited to Janet Elaine BLOOM, Maya Elaine BLOOM, Eran LEVIT, John R. ROBERTS, Timothy ROBERTS.
Application Number | 20140261407 14/213795 |
Document ID | / |
Family ID | 51521770 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140261407 |
Kind Code |
A1 |
ROBERTS; John R. ; et
al. |
September 18, 2014 |
ASPIRATION CATHETERS, SYSTEMS, AND METHODS
Abstract
The aspiration catheters, systems and methods include a catheter
having an elongated body with a cross-section having a flat side
and a curve near the distal end. The first side of the
cross-section can contact a first side of a delivery lumen in a
first orientation, and a second side of the cross-section contacts
the first side of the delivery lumen in a second orientation
rotated 180.degree. from the first orientation. The curve can be
directed 90.degree. relative to a normal of the flat side. The
systems and methods can utilize two catheters, and a key joint
formed with the two catheters which can rotationally fix the
catheters with respect to each other, and the first and second
catheters each include at least one pre-formed curve near the
distal end. The two catheters can be moved proximally and distally
for positioning in the right and left bronchi.
Inventors: |
ROBERTS; John R.;
(Brentwood, TN) ; LEVIT; Eran; (Amherst, NH)
; BLOOM; Janet Elaine; (Hopkinton, NH) ; ROBERTS;
Timothy; (Brentwood, TN) ; BLOOM; Maya Elaine;
(Hopkinton, NH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Patient Centered Medical Incorporated |
Brentwood |
TN |
US |
|
|
Assignee: |
Patient Centered Medical
Incorporated
Brentwood
TN
|
Family ID: |
51521770 |
Appl. No.: |
14/213795 |
Filed: |
March 14, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61786286 |
Mar 14, 2013 |
|
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|
61921910 |
Dec 30, 2013 |
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Current U.S.
Class: |
128/202.16 ;
604/28; 604/43; 604/514; 604/523; 604/538 |
Current CPC
Class: |
A61M 16/04 20130101;
A61M 25/0068 20130101; A61M 39/10 20130101; A61M 16/0486 20140204;
A61M 25/0067 20130101; A61M 16/0404 20140204; A61M 16/0418
20140204; A61M 16/0484 20140204; A61M 25/007 20130101; A61M
2025/0681 20130101; A61M 25/0015 20130101; A61M 25/0021 20130101;
A61M 25/0023 20130101; A61M 25/0041 20130101; A61M 16/0431
20140204; A61M 25/0111 20130101; A61M 16/0463 20130101 |
Class at
Publication: |
128/202.16 ;
604/523; 604/538; 604/514; 604/43; 604/28 |
International
Class: |
A61M 16/04 20060101
A61M016/04; A61M 25/00 20060101 A61M025/00; A61M 39/10 20060101
A61M039/10 |
Claims
1. A catheter for insertion into a body lumen of a patient,
comprising: a distal end configured for insertion into the body
lumen of the patient; a proximal end; an elongated body extending
between the proximal and distal ends and having a cross-section
that includes, over at least a portion of the elongated body, a
first side that is flat and a second side on an opposite side of
the cross-section from the first side; and at least one lumen
extending through the elongated body from the proximal end to the
distal end, wherein the elongated body includes at least one
pre-formed curve near the distal end, wherein, when the distal end
is adapted for insertion into the body lumen of the patient, the
first side of the cross-section contacts a first inner side of a
delivery lumen of the catheter when the catheter is in a first
orientation, and the second side of the cross-section contacts the
first inner side of the delivery lumen of the catheter when the
catheter is in a second orientation, the second orientation being a
180.degree. rotation of the catheter about a longitudinal axis of
the elongated body relative to the first orientation, and wherein a
curve direction of the at least one pre-formed curve is 90.degree.
with respect to a normal direction of the flat side of the
cross-section.
2. The catheter according to claim 1, wherein the second side of
the cross-section is curved.
3. The catheter according to claim 2, wherein the cross-section is
D-shaped.
4. The catheter according to claim 1, further comprising: a
curve-direction indicator on the proximal end that indicates a
curve direction of the at least one pre-formed curve of the distal
end of the catheter.
5. The catheter according to claim 4, wherein the curve-direction
indicator comprises a connector on the proximal end.
6. The catheter according to claim 5, wherein the connector
includes a central connection portion and a side connection portion
extending from the central connection portion, wherein a direction
in which the side connection portion extends corresponds to the
curve direction of the at least one preformed curve.
7. The catheter according to claim 1, wherein the at least one
curve and the first side are arranged such that, when the distal
end is adapted for insertion into the body lumen of the patient,
the at least one curve directs the elongated body toward one of a
left bronchus and a right bronchus of the patient in the first
orientation, and toward the other of the left bronchus and the
right bronchus of the patient in the second orientation.
8. The catheter according to claim 7, wherein the catheter has a
torsional stiffness such that, when the distal end is adapted for
insertion into the body lumen of the patient, the distal end
remains disposed toward one of the left bronchus and the right
bronchus within an angle of rotation of the proximal end from
0.degree. to a first predetermined angle, the angle of rotation of
the proximal end being relative to one of the first and second
orientations, and wherein the distal end is disposed toward the
other of the left and right bronchus when the proximal end is
between the first predetermined angle and a second predetermined
angle.
9. The catheter according to claim 8, wherein the first
predetermined angle is at least 90.degree., and the second
predetermined angle is at least 180.degree..
10. The catheter according to claim 9, wherein the first
predetermined angle is at least 150.degree. and the second
predetermined angle is at least 210.degree..
11. The catheter according to claim 9, wherein the first
predetermined angle is about 180.degree. and the second
predetermined angle is about 360.degree..
12. A catheter for insertion into a body lumen of a patient,
comprising: a distal end configured for insertion into the body
lumen of the patient; a proximal end; an elongated body extending
between the proximal and distal ends and having a cross-section
that includes, over at least a portion of the elongated body, a
portion that is substantially flat, the elongated body having a
torqueability ratio of 1:1 between the distal and proximal ends;
and at least one lumen extending through the elongated body from
the proximal end to the distal end, wherein the elongated body is
adapted to be arranged in a delivery lumen of an outer catheter
such that, when the distal end is adapted for insertion into the
body lumen of the patient, the distal end is directed toward one of
a left bronchus and a right bronchus of the patient, and wherein
the elongated body is configured such that the distal end remains
directed toward the one of the left and right bronchi during a
rotation of the proximal end about a longitudinal axis of the
elongated body until a predetermined angle of rotation of the
proximal end is reached, at which point the distal end flips to the
other of the left bronchus and the right bronchus.
13. The catheter according to claim 12, wherein the predetermined
angle is at least 90.degree..
14. The catheter according to claim 13, wherein the predetermined
angle is about 180.degree..
15. The catheter according to claim 12, wherein the elongated body
includes at least one pre-formed curve near the distal end that
directs the distal end toward one of the left bronchus and the
right bronchus.
16. The catheter according to claim 12, wherein, when the distal
end is adapted for insertion into the body lumen of the patient,
the portion that is substantially flat contacts a first inner side
of the delivery lumen when the catheter is in a first orientation,
and the portion that is substantially flat does not contact the
first inner side of the delivery lumen when the catheter is in a
second orientation, the distal end being directed toward one of the
left bronchus and the right bronchus in the first orientation and
toward the other of the left and right bronchi in the second
orientation.
17. The catheter according to claim 16, wherein the portion that is
substantially flat contacts the first inner side of the delivery
lumen at only one point in the first orientation.
18. The catheter according to claim 16, wherein the portion that is
substantially flat contacts the first inner side of the delivery
lumen at only two points in at least one of the first and the
second orientations.
19. The catheter according to claim 12, wherein the catheter is
comprised of a copolymer.
20. The catheter according to claim 19, wherein the copolymer is
chosen from the Kynar Flex.RTM. Copolymer Series.
21. A catheter for insertion into a body lumen of a patient,
comprising: a distal end configured for insertion into the body
lumen of the patient; a proximal end; an elongated body extending
between the proximal and distal ends and having a torqueability
ratio of 1:1 between the distal and proximal ends; and at least one
lumen extending through the elongated body from the proximal end to
the distal end, wherein the elongated body has a torsional
stiffness such that, when the elongated body is adapted for
insertion into a delivery lumen of an outer catheter, the distal
end remains in one of a first resting orientation and a second
resting orientation during a rotation of the proximal end about a
longitudinal axis of the catheter.
22. The catheter according to claim 21, wherein the distal end
remains in the first resting orientation through greater than
90.degree. of rotation of the proximal end.
23. The catheter according to claim 22, wherein the distal end
changes from the first resting orientation to the second resting
orientation when the proximal end rotates about 180.degree..
24. A method of orienting a catheter in a body lumen of a patient,
comprising: providing the catheter, the catheter having a distal
end configured for insertion into the body lumen of the patient, a
proximal end, and an elongated body extending between the proximal
and distal ends; providing an outer catheter adapted to be inserted
into a body lumen of a patient and to receive the distal end of the
catheter; inserting the catheter into the body lumen of the patient
through the outer catheter; rotationally orienting the proximal end
of the catheter to a first orientation, the distal end of the
catheter being directed toward one of a left bronchus and a right
bronchus of the patient in the first orientation; changing a
direction of the distal end of the catheter by rotating the
proximal end of the catheter to a second orientation, the second
orientation being a substantially 180.degree. rotation of the
proximal end relative to the first orientation, the distal end
being directed toward the other of the left and right bronchi when
the proximal end is in the second orientation.
25. A catheter for insertion into a body lumen of a patient,
comprising: a distal end configured for insertion into the body
lumen of the patient; a proximal end; an elongated body extending
between the proximal and distal ends and having a cross-section
that includes, over at least a portion of the elongated body, a
portion that is substantially flat; at least one lumen extending
through the elongated body from the proximal end to the distal end;
and at least one pre-formed curve near the distal end of the
elongated body, wherein the at least one pre-formed curve curves
the catheter in a direction that is orthogonal to a normal
direction of the flat side of the cross-section.
26. The catheter according to claim 25, wherein the elongated body
has a torqueability ratio of 1:1 between the distal and proximal
ends.
27. The catheter according to claim 25, wherein the elongated body
is configured such that the distal end remains directed toward one
of a left bronchus and a right bronchus during a rotation of the
proximal end about a longitudinal axis of the elongated body until
a predetermined angle of rotation of the proximal end is reached,
at which point the distal end flips to the other of the left
bronchus and the right bronchus
28. The catheter according to claim 25, wherein the at least one
lumen comprises: a first lumen with a first opening near the distal
end of the catheter, and a second lumen with a second opening near
the distal end of the catheter, the second opening being spaced
apart from the first opening such that the first opening is
disposed distally to the second opening.
29. The catheter according to claim 28, wherein the second opening
is disposed on the at least one pre-formed curve on the inside of
the curve of the at least one pre-formed curve.
30. The catheter according to claim 25, wherein an outside curve
surface of the at least one preformed curve is a smooth surface
that is uninterrupted by any opening to the at least one lumen of
the catheter.
31. The catheter according to claim 25, wherein the at least one
pre-formed curve comprises a first curve and a second curve, and
wherein the at least one lumen comprises: a first lumen with a
first opening disposed on an inside curve of the first curve, and a
second lumen with a second opening disposed on an inside curve of
the second curve.
32. The catheter according to claim 31, wherein the inside curve of
the first curve faces a different direction than the inside curve
of the second curve.
33. The catheter according to claim 26, wherein the cross-section,
over at least another portion of the elongated body, does not have
a flat side.
34. The catheter according to claim 33, wherein the at least
another portion of the elongated body comprises an opening of at
least one of the at least one lumen, the opening being near the
distal end of the catheter.
35. The catheter according to claim 25, wherein at least a portion
of the elongated body comprises a first key joint component, and
wherein the catheter further comprises: a second key joint
component that is keyed to the first key joint component, the
second key joint component being disposed outside of the patient
when the distal end of the catheter is adapted for insertion into
the body lumen, wherein the second key joint component is
rotationally fixed with response to the catheter.
36. The catheter according to claim 25, further comprising: a
delivery lumen configured to surround at least a portion of the
elongated body when the distal end of the elongated body is adapted
for insertion into the body lumen, wherein a portion of the
elongated body engages an inner surface of the delivery lumen when
the pre-formed curve is curved toward at least one of the left
bronchus and the right bronchus.
37. The catheter according to claim 36, wherein the delivery lumen
is an endotracheal tube.
38. The catheter according to claim 36, wherein the portion of the
elongated body that engages the inner surface of the delivery lumen
is the portion of the elongated body that is substantially
flat.
39. The catheter according to claim 25, wherein the catheter
comprises two catheters, each of the two catheters comprising: a
distal end configured for insertion into the body lumen of the
patient; a proximal end; an elongated body extending between the
proximal and distal ends and having a cross-section that includes,
over at least a portion of the elongated body, a portion that is
substantially flat; at least one lumen extending through the
elongated body from the proximal end to the distal end; and at
least one pre-formed curve near the distal end of the elongated
body.
40. The catheter according to claim 39, wherein the two catheters
are rotationally fixed relative to each other such that the flat
side of one of the two catheters faces the flat side of the other
of the two catheters.
41. The catheter according to claim 39, wherein each of the two
catheters is independently slideable relative to the other of the
two catheters.
42. The catheter according to claim 39, wherein the at least one
pre-formed curve curves the catheter in a direction that is
orthogonal to a normal direction of the flat side of the
cross-section.
43. The catheter according to claim 39, wherein the pre-formed
curves of the two catheters curve the two catheters in opposite
directions.
44. The catheter according to claim 43, wherein an outside curve of
the pre-formed curve of one of the two catheters faces an outside
curve of the pre-formed curve of the other of the two
catheters.
45. A catheter system comprising: a first catheter including: a
proximal end, a distal end configured for insertion into a body
lumen of a patient, an elongated body extending between the
proximal and distal ends and having a cross-section that includes,
over at least a portion of the elongated body, a first side that is
flat and a second side on an opposite side of the cross-section
from the first side, and at least one lumen extending through the
elongated body from the proximal end to the distal end; a second
catheter including: a proximal end, a distal end configured for
insertion into the body lumen of the patient, an elongated body
extending between the proximal and distal ends and having a
cross-section that includes, over at least a portion of the
elongated body, a first side that is flat and a second side on an
opposite side of the cross-section from the first side, and at
least one lumen extending through the elongated body from the
proximal end to the distal end; a key joint component configured to
form a key joint with at least a portion of the elongated bodies
near the proximal ends of both the first and second catheters, the
portion of the elongated bodies that form the key joint including
the first sides that are flat, wherein the first and second
catheters are rotationally fixed with respect to each other via the
key joint, wherein the elongated bodies of the first and second
catheters each include at least one pre-formed curve near the
distal end.
46. The catheter system of claim 45, wherein at least one of the
first and second catheters are slideable relative to the key joint
component through the key joint.
47. The catheter system of claim 45, wherein the elongated bodies
of the first and second catheters each have a torqueability ratio
of 1:1 between the distal and proximal ends.
48. The catheter system of claim 45, wherein the key joint
component is keyed to the first and second catheters such that the
first side of the elongated body of the first catheter faces the
first side of the elongated body of the second catheter.
49. The catheter system of claim 48, wherein, when keyed with the
key joint component, the at least one pre-formed curves of the
first and second catheters curve in substantially opposite
directions.
50. The catheter system of claim 45, further comprising a delivery
lumen configured to surround at least a portion of the elongated
bodies of both the first and second catheters when they are keyed
by the key joint component.
51. The catheter system of claim 50, wherein the first and second
catheters are slideable relative to the delivery lumen, and wherein
the distal ends of the first and second catheters are configured to
move away from each other as the distal ends slide out of the
delivery catheter.
52. The catheter system of claim 50, wherein the first and second
catheters are rotatable relative to the delivery lumen while at
least a portion of the elongated bodies of the first and second
catheters are surrounded by the delivery lumen.
53. The catheter system of claim 50, wherein the first and second
catheters are not rotatable relative to the delivery lumen while at
least a portion of the elongated bodies of the first and second
catheters are surrounded by the delivery lumen.
54. The catheter system of claim 45, wherein the first and second
catheters each have a D-shaped cross-section.
55. The catheter system of claim 45, wherein, for each of the first
and second catheters, a curve direction of the at least one
pre-formed curve is orthogonal to a normal vector of the first side
that is flat.
56. A method of using a catheter system comprising: providing a
dual catheter system comprising: a first catheter and a second
catheter, each of the first and second catheters having a proximal
end, a distal end configured for insertion into a body lumen of a
patient, an elongated body extending between the proximal and
distal ends and having a cross-section that includes, over at least
a portion of the elongated body, a first side that is flat and a
second side on an opposite side of the cross-section from the first
side, and a key joint component configured to form a key joint with
at least a portion of the elongated bodies near the proximal ends
of both the first and second catheters, the portion of the
elongated bodies that form the key joint including the first sides
that are flat, the first and second catheters being rotationally
fixed relative to the key joint component via the key joint, and
the first side that is flat of the first catheter facing the first
side that is flat of the second catheter; advancing the distal ends
of the first and second catheters through the body lumen of the
patient; and controlling a disposition of the first and second
catheters such that at least one of the first and second catheters
is directed toward one of a left bronchus and a right bronchus of
the patient.
57. The method of using a catheter system of claim 56, wherein the
catheter system further comprises a delivery catheter having a
proximal end, a distal end, and at least one lumen extending
between the proximal and distal ends, the delivery catheter being
configured to be positioned at least partially within the body
lumen and to surround at least a portion of the elongated bodies of
the first and second catheters.
58. The method of using a catheter system of claim 57, wherein the
advancing of the distal ends of the first and second catheters
includes advancing the distal ends of the first and second
catheters past the distal end of the delivery catheter, wherein the
distal ends of the first and second catheters move away from each
other as they advance past the distal end of the delivery
catheter.
59. The method of using a catheter system of claim 56, wherein each
of the first and second catheters further includes a pre-formed
curve near the distal end of the first and second catheter.
60. The method of using a catheter system of claim 58, wherein each
of the first and second catheters have a torqueability ratio of
1:1.
61. The method of using a catheter system of claim 56, wherein, for
each of the first and second catheters, a curve direction of the at
least one pre-formed curve is orthogonal to a normal vector of the
first side that is flat.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Nos. 61/786,286 filed Mar. 15, 2013; and 61/921,910,
filed Dec. 30, 2013, the disclosures of which are both incorporated
herein by reference in their entireties.
TECHNICAL FIELD
[0002] The present invention relates to medical devices and, in
particular, to catheters that can be reliably advanced into
tortuous body lumens and for which the location and orientation of
the catheters within body lumens can be reliably verified.
BACKGROUND
[0003] Suction catheters are used to remove respiratory secretions
and other material from airways, and in general for treating or
preventing a number of respiratory conditions. For example, when
patients develop pneumonia or bronchitis they cough to clear the
airways. If, however, the pneumonia worsens enough to require
intubation with an endotracheal tube and placement on a ventilator
(breathing machine), patients are unable to cough (due to sedation
and the mechanical impediment of the endotracheal tube), and so
suction catheters are passed into the endotracheal tube to clear
the infected mucous and thus improve the ability to breathe and to
help treat the infection. Suction catheters may also be used in
patients without pneumonia to prevent the occurrence of pneumonia
or other respiratory complications. However, the right bronchus
(airway) is straighter and of greater diameter, so that suction
catheters passed into the trachea go into the right bronchus more
than 98% of the time. This anatomic fact is well known by all
physicians (pulmonologists, surgeons and anesthesiologists) who
manage the airway.
[0004] The current suction catheters are passed blindly into the
trachea and cannot be directed into either side. They are connected
to the endotracheal tube, and kept on the patient's bed inside a
sleeve that is not sterilized, and allow the bacteria to grow and
accumulate. Thus, the catheters become contaminated, contaminate
the sleeve, and re-introduce the same bacteria back into the
patient's airway when suctioning is repeated. Thus, it
re-introduces the problem that it is designed to eradicate:
infected secretions.
[0005] Because usually only the right lung is cleared of
secretions, the left lung becomes a reservoir of infection, even if
the right lung is the source of infection, as secretions from
either lung move or contaminate the opposite lung. If the right
lung is the source of the pneumonia, for example, this reservoir
may be limited. However, if the left lung is the source, it will
never be cleared by standard suctioning, and often requires
bronchoscopy. This failure to clear the lung prolongs time on the
ventilator, prolongs the recovery time from pneumonia, and
increases the risk of developing resistant infections and of dying
from pneumonia.
[0006] Together, pneumonia and influenza represented a cost to the
U.S. economy in 2005 of $40.2 billion, $6 billion due to indirect
mortality I costs and $34.2 billion in direct II costs, according
to the American Lung Association. According to preliminary
mortality data from 2011 from the CDC, age-adjusted death rates
decreased significantly from 2010 to 2011 for 5 of the 15 leading
causes of death (heart diseases, Malignant neoplasms,
Cerebrovascular disease, Alzheimer's disease, and kidney diseases).
However, the age-adjusted death rate increased for six leading
causes of death: Chronic lower respiratory diseases, Diabetes
mellitus, Influenza and pneumonia, Chronic liver disease and
cirrhosis, Parkinson's disease, and Pneumonitis due to solids and
liquids. Three of these causes (chronic lower respiratory disease,
influenza and pneumonia, and pneumonitis) are all variants of
pneumonia. These data demonstrate that pneumonia is an already
dangerous disease that is becoming more deadly.
[0007] There exists a need for improved treatment and prevention of
pneumonia and other respiratory conditions and complications.
BRIEF SUMMARY OF THE INVENTION
[0008] An embodiment of the present invention may provide a
catheter for insertion into a body lumen of a patient. The catheter
may include a distal end for insertion into the body lumen of the
patient, a proximal end, and an elongated body extending between
the proximal and distal ends. The elongated body may have a
cross-section that includes, over at least a portion of the
elongated body, a first side that is flat and a second side on an
opposite side of the cross-section from the first side. The
catheter may also include at least one lumen extending through the
elongated body from the proximal end to the distal end, and at
least one pre-formed curve near the distal end. When the distal end
is inserted into the body lumen of the patient, the first side of
the cross-section may contact a first inner side of a delivery
lumen of the catheter while the catheter is in a first orientation,
and the second side of the cross-section may contact the first
inner side of the delivery lumen of the catheter while the catheter
is in a second orientation. The second orientation may be a
180.degree. rotation of the catheter about a longitudinal axis of
the elongated body relative to the first orientation. The
pre-formed curve may have a curve direction that is 90.degree. with
respect to a normal direction of the flat side of the
cross-section.
[0009] Embodiments of the present invention may include a catheter
having a distal end for insertion into the body lumen of the
patient, a proximal end, and an elongated body extending between
the proximal and distal ends. The elongated body may have a
cross-section that includes, over at least a portion of the
elongated body, a portion that is substantially flat, and also may
have a torqueability ratio of 1:1 between the distal and proximal
ends. The catheter may also include at least one lumen extending
through the elongated body from the proximal end to the distal end.
The elongated body may be arranged in a delivery lumen of an outer
catheter such that, when the distal end is inserted into the body
lumen of the patient, the distal end is directed toward one of a
left bronchus and a right bronchus of the patient. The distal end
may remain directed toward the one of the left and right bronchi
during a rotation of the proximal end about a longitudinal axis of
the elongated body until a predetermined angle of rotation of the
proximal end is reached, at which point the distal end may flip to
the other of the left bronchus and the right bronchus.
[0010] Embodiments of the present invention may include a catheter
for insertion into a body lumen of a patient. The catheter may
include a distal end, a proximal end, and an elongated body
extending between the proximal and distal ends and having a
torqueability ratio of 1:1 between the distal and proximal ends.
The catheter may also include at least one lumen extending through
the elongated body from the proximal end to the distal end. The
elongated body may also have a torsional stiffness such that, when
the elongated body is inserted into a delivery lumen of an outer
catheter, the distal end remains in one of a first resting
orientation and a second resting orientation during a rotation of
the proximal end about a longitudinal axis of the catheter.
[0011] Embodiments of the present invention may provide a method of
orienting a catheter in a body lumen of a patient. The method may
include providing the catheter that may have a distal end, a
proximal end, and an elongated body extending between the proximal
and distal ends. The method may also include providing an outer
catheter for insertion into a body lumen of a patient and to
receive the distal end of the catheter. The method may further
include inserting the catheter into the body lumen of the patient
through the outer catheter, and rotationally orienting the proximal
end of the catheter to a first orientation. The distal end of the
catheter may be directed toward one of a left bronchus and a right
bronchus of the patient in the first orientation. The method may
further include changing a direction of the distal end of the
catheter by rotating the proximal end of the catheter to a second
orientation, the second orientation being a substantially
180.degree. rotation of the proximal end relative to the first
orientation, and the distal end being directed toward the other of
the left and right bronchi when the proximal end is in the second
orientation.
[0012] Embodiments of the present invention may provide a catheter
for insertion into a body lumen of a patient. The catheter may
include a distal end for insertion into the body lumen of the
patient, a proximal end, and an elongated body extending between
the proximal and distal ends. The elongated body may have a
cross-section that includes, over at least a portion of the
elongated body, a portion that is substantially flat. The catheter
may also include at least one lumen extending through the elongated
body from the proximal end to the distal end, and at least one
pre-formed curve near the distal end of the elongated body. The at
least one pre-formed curve may curve the catheter in a direction
that is orthogonal to a normal direction of the flat side of the
cross-section.
[0013] Embodiments of the present invention may also provide a
catheter system that includes a first catheter. The first catheter
may include a proximal end, a distal end for insertion into a body
lumen of a patient, and an elongated body extending between the
proximal and distal ends. The elongated body may have a
cross-section that includes, over at least a portion of the
elongated body, a first side that is flat and a second side on an
opposite side of the cross-section from the first side, and may
also have at least one lumen extending through the elongated body
from the proximal end to the distal end. The catheter system may
also include a second catheter that can include a proximal end, a
distal end, an elongated body extending between the proximal and
distal ends and having a cross-section that includes, over at least
a portion of the elongated body, a first side that is flat and a
second side on an opposite side of the cross-section from the first
side. The elongated body of the second catheter may also include at
least one lumen extending through the elongated body from the
proximal end to the distal end. The catheter system may include a
key joint component to form a key joint with at least a portion of
the elongated bodies near the proximal ends of both the first and
second catheters, the portion of the elongated bodies that form the
key joint including the first sides that are flat. The first and
second catheters may be rotationally fixed with respect to each
other via the key joint, and the elongated bodies of the first and
second catheters may each include at least one pre-formed curve
near the distal end.
[0014] Embodiments of the present invention may provide a method of
using a catheter system. The method may include providing a dual
catheter system including a first catheter and a second catheter.
Each of the first and second catheters may have a proximal end, a
distal end, and an elongated body extending between the proximal
and distal ends. The elongated body may have a cross-section that
includes, over at least a portion of the elongated body, a first
side that is flat and a second side on an opposite side of the
cross-section from the first side. The catheter system may also
include a key joint component configured to form a key joint with
at least a portion of the elongated bodies near the proximal ends
of both the first and second catheters. The portion of the
elongated bodies that form the key joint may include the first
sides that are flat. The first and second catheters may be
rotationally fixed relative to the key joint component via the key
joint. The first side that is flat of the first catheter may face
the first side that is flat of the second catheter. The method may
also include advancing the distal ends of the first and second
catheters through the body lumen of the patient, and controlling a
disposition of the first and second catheters such that at least
one of the first and second catheters is directed toward one of a
left bronchus and a right bronchus of the patient
Additional features, advantages, and embodiments of the invention
are set forth or apparent from consideration of the following
detailed description, drawings and claims. Moreover, it is to be
understood that both the foregoing summary of the invention and the
following detailed description are exemplary and intended to
provide further explanation without limiting the scope of the
invention as claimed.
BRIEF DESCRIPTION OF DRAWINGS
[0015] The accompanying drawings, which are included to provide a
further understanding of the invention and are incorporated in and
constitute a part of this specification, illustrate preferred
embodiments of the invention and together with the detailed
description serve to explain the principles of the invention. In
the drawings:
[0016] FIG. 1 shows a view of a catheter system with endotracheal
tube in an embodiment of the present invention.
[0017] FIG. 2A shows a close-up side view of the connection portion
of the catheter system shown in FIG. 1 that connects to the
endotracheal tube in an embodiment of the present invention.
[0018] FIG. 2B shows an opposite side view of the connection
portion shown in FIG. 2A in an embodiment of the present
invention.
[0019] FIG. 2C shows a top view of the connection portion shown in
FIG. 2A in an embodiment of the present invention.
[0020] FIG. 2D shows a bottom view of the connection portion shown
in FIG. 2A in an embodiment of the present invention.
[0021] FIG. 3A shows a cross-section view, according to the broken
line in FIG. 2B, of the connection portion with a key joint
component of a first catheter, and a second and third catheter
forming a keyed joint with the key joint component of the first
catheter in an embodiment of the present invention.
[0022] FIG. 3B shows a side perspective view of the connection
portion with the second and third catheters extending from the key
joint component of the first catheter in an embodiment of the
present invention.
[0023] FIG. 4A shows another perspective view of the catheter
system shown in FIG. 3B in an embodiment of the present
invention.
[0024] FIG. 4B shows another perspective of the catheter system
shown in FIG. 4A in an embodiment of the present invention.
[0025] FIG. 5 shows a side view of an endotracheal tube connected
to a catheter system having a single internal catheter within a
first catheter in an embodiment of the present invention.
[0026] FIG. 6A shows a close-up side view of the connection portion
of the catheter system shown in FIG. 5 that connects to the
endotracheal tube in an embodiment of the present invention.
[0027] FIG. 6B shows an opposite side view of the connection
portion shown in FIG. 6A in an embodiment of the present
invention.
[0028] FIG. 6C shows a top view of the connection portion shown in
FIG. 6A in an embodiment of the present invention.
[0029] FIG. 6D shows a bottom view of the connection portion shown
in FIG. 6A in an embodiment of the present invention.
[0030] FIG. 7A shows a cross-section view, according to the broken
line in FIG. 6B, of the connection portion with a key joint
component of a first catheter and a second catheter forming a keyed
joint with the key joint component of the first catheter in an
embodiment of the present invention.
[0031] FIG. 7B shows a side perspective view of the connection
portion with the second catheter extending from the key joint
component of the first catheter in an embodiment of the present
invention.
[0032] FIG. 8A shows another perspective view of the catheter
system shown in FIG. 7B in an embodiment of the present
invention.
[0033] FIG. 8B shows another perspective view of the catheter
system shown in FIG. 7B in an embodiment of the present
invention.
[0034] FIG. 9A shows a catheter system with an endotracheal tube
disposed within a patient prior to inner catheters being extended
from the endotracheal tube in an embodiment of the present
invention.
[0035] FIG. 9B shows a close-up view of the end of the endotracheal
tube shown in FIG. 9A as the inner catheters are about to emerge
from the endotracheal tube in an embodiment of the present
invention, and reliably passing by the Murphy's eye in the
endotracheal tube.
[0036] FIG. 9C shows a close-up view of the system shown in FIG. 9A
after the inner catheters have emerged from the endotracheal tube
in an embodiment of the present invention.
[0037] FIG. 9D shows a close-up view of the system shown in FIG. 9A
after the inner catheters have extended farther than the position
shown in FIG. 9C in an embodiment of the present invention where
the placement can be accomplished by a push/pull positioning alone,
and/or in combination with rotation of the pair of catheters as
shown by a rotational arrow.
[0038] FIG. 9E shows a close-up view of the system shown in FIG. 9A
after one of the inner catheters has extended farther than the
position shown in FIG. 9D, the directional arrow indicating that
the catheters are independent and separately moveable to target
separate areas or lumens in an embodiment of the present
invention.
[0039] FIG. 9F shows a catheter system with only a single inner
catheter extending out of the endotracheal tube which can indicate
that the second catheter was removed and can be reintroduced and/or
the single catheter can be delivered as a single catheter in an
embodiment of the present invention.
[0040] FIG. 10 shows a cross-section of an inner catheter in an
embodiment of the present invention.
[0041] FIG. 11A shows a bottom view of an inner catheter in an
embodiment of the present invention.
[0042] FIG. 11B shows a side view of the inner catheter shown in
FIG. 11A in an embodiment of the present invention.
[0043] FIG. 11C shows a cross-section detail view of one end of the
inner catheter shown in FIG. 11B in an embodiment of the present
invention.
[0044] FIG. 12 shows a cross-section of an inner catheter in an
embodiment of the present invention.
[0045] FIG. 13 shows a catheter system with a single inner catheter
extended in a first orientation into a patient in an embodiment of
the present invention.
[0046] FIG. 14 shows a catheter system with a single inner catheter
extended in a second orientation into a patient in an embodiment of
the present invention.
[0047] FIG. 15A shows a bottom view of an inner catheter in an
embodiment of the present invention.
[0048] FIG. 15B shows a side view of the inner catheter shown in
FIG. 15A in an embodiment of the present invention.
[0049] FIG. 15C shows an end tip of an inner catheter in an
embodiment of the present invention.
[0050] FIG. 15D shows a cross-section detail view of one end of the
inner catheter shown in FIG. 15B in an embodiment of the present
invention.
[0051] FIG. 15E shows a shape of a distal end of an inner catheter
in an embodiment of the present invention.
[0052] FIG. 15F shows a shape of a distal end of an inner catheter
in an embodiment of the present invention.
[0053] FIG. 15G shows a shape of a distal end of an inner catheter
in an embodiment of the present invention.
[0054] FIG. 15H shows a shape of a distal end of an inner catheter
in an embodiment of the present invention.
[0055] FIG. 16A shows a top view of a connection portion of the
catheter system in an embodiment of the present invention.
[0056] FIG. 16B shows a cross-section of the connection portion
shown in FIG. 16A, viewed according to the broken line in FIG. 16A,
in an embodiment of the present invention.
[0057] FIG. 16C shows a close-up view of the portion of the
connection portion that is circled in FIG. 16B with a key joint
component of the connection portion in an embodiment of the present
invention.
[0058] FIG. 16D shows a view of the connection portion of FIG. 16A
that is axial with the lumen of the catheter, showing the key joint
component in an embodiment of the present invention.
[0059] FIG. 17A shows a side view of a catheter system with a
single inner catheter in an embodiment of the present
invention.
[0060] FIG. 17B shows a close-up view of the connection portion of
the catheter system shown in FIG. 17A with the key joint component
for the single inner catheter in an embodiment of the present
invention.
[0061] FIG. 17C shows a bottom view of the catheter system shown in
FIG. 17A in an embodiment of the present invention.
[0062] FIG. 18A shows a side view of a catheter system with two
inner catheters in an embodiment of the present invention.
[0063] FIG. 18B shows a close-up view of the connection portion of
the catheter system shown in FIG. 18A with the key joint component
for the two inner catheters in an embodiment of the present
invention.
[0064] FIG. 18C shows a bottom view of the catheter system shown in
FIG. 18A with the two inner catheters oriented in different
directions in an embodiment of the present invention.
[0065] FIG. 18D shows a close-up of the ends of the inner catheters
shown in FIG. 18C in an embodiment of the present invention.
[0066] FIG. 19 shows a catheter system being operated in a first
orientation by a hand of a user in an embodiment of the present
invention.
[0067] FIG. 20 shows a catheter system being operated in a second
orientation by a hand of a user in an embodiment of the present
invention.
[0068] FIG. 21 shows a side view of a catheter system in an
embodiment of the present invention.
[0069] FIG. 22 shows a close-up view of a distal end portion of the
system shown in FIG. 21 in an embodiment of the present
invention.
[0070] FIG. 23 shows a close-up view of the distal end portion
shown in FIG. 22 as shown in an opposite orientation in an
embodiment of the present invention.
[0071] FIG. 24 shows a proximal end of the catheter system in an
embodiment of the present invention.
[0072] FIG. 25 shows a view of a catheter system having a
lubricious sleeve in an embodiment of the present invention.
[0073] FIG. 26A shows a side view of a catheter according to an
embodiment of the present invention.
[0074] FIG. 26B shows a side view of a distal end of the catheter
shown in FIG. 26A according to an embodiment of the present
invention.
[0075] FIG. 26C shows a first side view of the distal end of the
catheter shown in FIG. 26A according to an embodiment of the
present invention.
[0076] FIG. 26D shows a second side view of the distal end of the
catheter shown in FIG. 26A according to an embodiment of the
present invention.
[0077] FIG. 26E shows an additional first side view of the distal
end of the catheter shown in FIG. 26A according to an embodiment of
the present invention.
[0078] FIG. 26F shows a front view of distal end of the catheter
shown in FIG. 26A according to an embodiment of the present
invention.
[0079] FIG. 27 is a cross-section view of the catheter in an
embodiment of the present invention.
[0080] FIGS. 28A, 28B, 28C, 28D, and 28E show schematics of
catheters when inserted into delivery catheters according to an
embodiment of the present invention, with the portion of the
catheter that is shown in FIGS. 28A-28E being indicated by the
dashed line C in FIG. 9A.
[0081] FIGS. 29A, 29B, 29C, 29D, and 29E show a binary response of
a distal end of the catheter in response to a rotation of the
proximal end of the catheter in an embodiment of the present
invention.
[0082] FIG. 30A shows a side view of the catheter in an embodiment
of the present invention.
[0083] FIG. 30B shows a cross-section view of the catheter taken
along line A-A in FIG. 30B in an embodiment of the present
invention.
[0084] FIGS. 31A, 31B, and 31C show curvatures of a distal end of
the catheter according to various embodiments of the present
invention.
[0085] FIGS. 32A, 32B, 32C, 32D, and 32E show the distal end of the
catheter in an embodiment of the present invention over time as it
emerges from an outer catheter having a Murphy's Eye opening.
[0086] FIG. 33A shows a bottom view of the distal end of the
catheter showing the flat side in an embodiment of the
invention.
[0087] FIG. 33B shows a side view of the distal end of the catheter
in an embodiment of the invention.
[0088] FIG. 33C shows a top view of the distal end of the catheter
in an embodiment of the invention.
[0089] FIG. 33D shows a front view of the distal end of the
catheter in an embodiment of the invention.
[0090] FIGS. 34A, 34B, 34C, 34D, 34E, and 34F show a variety of
isometric views of the distal end of the catheter in an embodiment
of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0091] Systems and methods are provided for positioning and using a
catheter within a body lumen of a patient (e.g., the left and right
main bronchi), without requiring direct visualization. The system
may allow the desired placement of a working catheter within either
bronchus without using endoscopy to assure placement.
[0092] The catheters, systems, and methods can be utilized in
various applications to suction and/or remove material, such as
respiratory secretions from the airways. The catheters, systems,
and methods can also be utilized for irrigation, alone, or in
combination with aspiration. The catheters, systems, and methods
can be used for treating and/or preventing conditions requiring
aspiration and/or irrigation, including any type of respiratory
conditions. Such respiratory conditions can include pneumonia or
bronchitis, for example, and prevention or treatment, for
example.
[0093] The system and methods may include various implementations,
examples of which are described herein. The methods and systems may
be implemented as open and/or closed methods and systems. The
catheters may be utilized as a single catheter, dual catheter,
and/or a combination of both.
[0094] In some embodiments, a catheter system includes a first
catheter including a first proximal end portion, a first body
portion, a first distal end portion, a lumen extending through the
first body portion from the first proximal end portion to the first
distal end portion, and a first key joint component. The catheter
system may also include a second catheter including a second
proximal end portion, a second body portion, a second distal end
portion, a primary lumen extending through the second body portion
from the second proximal end portion to the second distal end
portion, at least a portion of the second body portion being
disposed within the lumen of the first catheter, the second
catheter further including a second key joint component. The second
key joint component may form a first keyed joint with the first key
joint component such that the second catheter is rotationally fixed
with respect to the first key joint component via the first keyed
joint, the second distal end portion being configured be inserted
into a body of a patient. The second catheter may be configured to
have a torqueability ratio of 1:1 between the second distal end
portion and the second key joint component.
[0095] In some embodiments, a method of positioning and using a
catheter system is provided. The method of positioning and using at
least one catheter within a lumen of a body of a patient may
include providing a first catheter that includes a first distal end
portion, a first proximal end portion, a first lumen extending
between the first proximal end portion and the first distal end
portion, and a first key joint component. The method may further
include providing, within the first lumen of the first catheter, a
second catheter that includes a second distal end portion, a second
proximal end portion, a second lumen extending between the second
proximal end portion and the second distal end portion, and a
second key joint component forming a first keyed joint, within the
first distal end portion, with the first key joint component.
Further, the method may include extending the second distal end
portion of the second catheter from the first distal end portion
into the body of the patient, and positioning the second distal end
portion in a predetermined relationship with a first targeted lumen
within the body of the patient by rotating the first keyed joint
such that the second distal end portion is rotated into an
orientation for establishing the predetermined relationship.
[0096] In some embodiments, the catheter includes an elongated body
having a proximal end portion and a distal end portion. The
elongated body can define a lumen extending from the proximal end
portion to the distal end portion, and can include a key joint
component that corresponds with a key joint component of a lumen of
a delivery catheter. The key joint component of the elongated body
of the catheter can be configured to be selectively coupled to the
key joint component of the lumen of the delivery catheter such that
a rotational orientation of the catheter is fixed relative to a
rotation orientation of the delivery catheter.
[0097] In some embodiments, the catheter system includes a
ventilation adapter attached to the proximal end of an endotracheal
tube. The adapter includes a first key joint component. The first
catheter can include a first elongated body having a first proximal
end portion, a first distal end portion, and a shaped elongated
body disposed within the ventilation adapter. The catheter system
can also include a second catheter slideably disposed within the
ventilation adapter. The second catheter can include a second
elongated body having a second distal end portion and a second key
joint component that corresponds with the first key joint component
in the adapter. The adapter key joint component, the first catheter
key joint component and the second catheter key joint component can
be configured to be coupled together such that a rotational
orientation of the catheters is fixed relative to a rotational
orientation of the ventilation adapter.
[0098] In some embodiments, the catheter system includes a
ventilation adapter attached to the proximal end of an endotracheal
tube. The first catheter has a first elongated body including a
first proximal end portion, a first distal end portion, and first
and second lumens extending from the first proximal end portion to
the first distal end portion slideably disposed within the adapter.
The first catheter has a second elongated body including a second
distal end portion and a second proximal end portion. The second
distal end portion of the first catheter can include a pre-formed
bend that extends at a non-zero angle relative to a longitudinal
axis of the first catheter when the second distal end portion is
extended through the adapter. The catheter system can also include
a second catheter slideably disposed within the ventilation
adapter. The second catheter can have a second elongated body
including a second distal end portion and a second proximal end
portion. The second distal end portion of the second catheter can
include a pre-formed bend that extends at a non-zero angle relative
to a longitudinal axis of the second catheter when the second
distal end portion is extended through the adapter.
[0099] In some embodiments the suction tube is constructed so that
the distal end would be round and a-traumatic, and pre-curved to
ease the insertion process into the airway system. The outer side
of the curved tube may be marked so that the operator can orient it
appropriately when inserted.
[0100] In some embodiments the suction tube can be marked along the
entire length to indicate how deep the distal end is inserted. In
addition, the suction tubes are marked on the proximal part
protruding from the tracheal tube (when the distal end of the large
and smaller tubes are aligned) every 1 cm with a line around the
tube.
[0101] In some embodiments the suction tubes' distal ends are
visible under X-Ray, with the marker band secured to the distal
end.
[0102] In some embodiments the suction tube is constructed of two
or more lumens, one main lumen for suction and a secondary for
therapeutic agent infusion. The catheter is dual lumen; the primary
lumen may be used to aspirate mucus from the lungs. Because the
catheter can be keyed, the catheter form represents a novel device
as it can access entire either main branch of the bronchi and
aspirate mucus. The second lumen can be used to introduce saline
and perform lavage. The second lumen can also be used to introduce
a multitude of medications. In conjunction with aspiration the
ability to medicate after aspiration assures the medication
interfaces with tissue rather than sitting on mucus providing
little benefit to the patient. Thus, this invention can be a
multitude of devices, to be used for the following procedures:
[0103] Aspiration [0104] Lavage [0105] Aspiration with Lavage
[0106] Aspiration in conjunction with a drug delivery system [0107]
Aspiration, lavage and drug delivery
[0108] In some embodiments the suction tube main is constructed so
that the distal end would be round and a-traumatic, and the
proximal end connected to a suction type connector.
[0109] In some embodiments the suction tube secondary is
constructed so that the distal end is skived open, rounded and
a-traumatic. In this case, the inflation port may pass through a
y-piece and the proximal end thermally formed to be sealed near the
suction connector.
[0110] In some embodiments the suction tubes are keyed inside the
tracheal tube to control the orientation of the curved distal ends,
and ensure that the two distal ends of the suction tubes will be
pointed inside the tracheal tube to form a Y shape.
[0111] In some embodiments the suction tubes are pre-formed to
enable retraction into the tracheal tube and blind deployment into
the pre-formed curved form, confirming the two distal ends of the
suction tubes will point in opposite directions inside the tracheal
tube to form a Y shape.
[0112] In some embodiments, the above catheter system comprises a
closed system suction catheter assembly including the above
described suction catheter, a ventilation adapter that can be
attached to the proximal end of an endotracheal tube using a
fitting connected between the end of a tracheal tube and a
ventilation circuit. The above aspiration catheter can be advanced
through the forward coupling down the tracheal tube to enable
suctioning. A flexible envelope extends between the two couplings,
enclosing the catheter so that it can be manipulated through the
envelope. A wiper seal in the forward coupling prevents gas from
the ventilation system inflating the envelope.
[0113] In some embodiments the closed system suction catheter
assembly is used to remove secretions from within the trachea or
bronchi of an intubated patient. The assembly comprises a flexible
catheter connected at its distal end to the proximal end of an
endotracheal tube. The proximal end of the flexible catheter may be
connected with a fitting, including a valve that can be opened or
closed, to control the application of suction to the catheter.
[0114] In some embodiments, provision is made for cleaning the
catheter after its distal end has been withdrawn into the forward
coupling. A manually-operable valve is located forwardly of the
wiper seal providing a cleaning chamber between the valve and the
wiper seal. An irrigation port opens into this chamber so that
saline can be supplied to it, which is then drawn along the bore of
the catheter by the applied suction to remove matter collected
within the bore.
[0115] Methods for using catheter systems according to embodiments
described herein are also provided. FIG. 1 shows a catheter system
100 according to an embodiment. The system 100 includes an
elongated body 102 having a proximal end 104 and a distal end 106,
and a lumen 108 extending between the proximal end 104 and distal
end 106. Within the lumen 108 is a first inner catheter 116 having
a proximal end 120 and a distal end 122. A second inner catheter
117 may also be provided within the lumen 108, the second inner
catheter having a proximal end 121 and a distal end 123. The inner
catheters 116, 117 may emerge from one or both of the proximal and
distal ends 104, 106 of the elongated body 102. The elongated body
102 may be formed of a flexible envelope 140, which may enable a
user of the system 100 to manipulate one or both of the inner
catheters 116, 117 with the user's hands through the flexible
envelope 140. Thereby, the user may extend adjust the position or
extend one or both the inner catheters 116, 117 into a body of a
patient.
[0116] The distal end 106 of the elongated body 102 may include a
ventilation adapter portion 112 that may be provided with a fitting
138 to connect the system 100 to, for example, an endotracheal tube
114 or some other member. The first and second inner catheters 116,
117 may extend out through the ventilation adapter portion 112 and
through an attached member, such as the endotracheal tube 114, to
emerge from an opposite end of the endotracheal tube 114 positioned
within a body of a patient. Additionally, the fitting 138 may be
rotatable relative to the elongated body 102. The ventilation
adapter portion 112 may also include a ventilation adapter 154 for
providing ventilation to the patient.
[0117] The first and second inner catheters 116 and 117 may be
provided with connector portions 136 and 137, respectively, on the
proximal ends 120, 121. The connector portions 136, 137 may each
include a wiper seal 142 to prevent leakage when the connector
portions 136, 137 are connected to, for example, a source of a
fluid. The connector portions 136, 137 may each also include a
valve 146 and an irrigation port 152. In the embodiment shown in
FIG. 1, the valve 146 is a manually operated valve, but other
embodiments are also possible.
[0118] The distal end 122 of the first inner catheter 116 may have
a bend 128. The distal end 123 of the second inner catheter 117
also may have a bend 129. The bends 128 and 129 may curve in
opposite directions to create a V- or Y-shape formed by the first
and second inner catheters 116, 117.
[0119] FIG. 2A shows a close-up view of the ventilation adapter
portion 112 with no endotracheal tube connected to the fitting 138.
The ventilation adapter portion 112 may include a key joint
component (discussed below) that forms a keyed joint with one or
both inner catheters 116, 117. The keyed joint may, for example,
rotationally fix the inner catheters 116, 117 with respect to the
ventilation adapter portion 112. In the embodiment shown in FIG.
2A, the inner catheters 116, 117 are fixed such that the first
inner catheter 116 curves in the same direction as the direction in
which the ventilation adapter 154 points. As such, the ventilation
adapter 154 may serve as an indicator to a user of the orientation
of the distal ends 122, 123 of the inner catheters. However, other
configurations are possible. For example, the orientation of the
inner catheters may be indicated by some other feature provided on
the catheter system 100.
[0120] The shape of the inner catheters 116, 117 may be a D-shape,
with one side of the catheter curved, and the other side flat. FIG.
2A shows the curved side 156b of the first inner catheter 116 and
the flat side 157a of the second inner catheter 117. In the
configuration shown, the flat sides 156a (not shown) and 157a face
each other. The shapes and orientations of the inner catheters are
not limited to this configuration as other shapes and orientations
may be provided in accordance with the principles of the invention.
In embodiments where the catheters have differently shaped
cross-sections, the catheters may still have cross-sections with
flat sides that face each other, thereby allowing the catheters to
be in close proximity and minimizing the volume occupied by the
catheters. However, the catheters may have still other
cross-sectional shapes, and the facing sides may not be flat, but
may have sides that nonetheless correspond with one another.
Additionally, the cross-section of the catheter may not be constant
across the entire length of the catheter. For example, FIG. 3B
shows a circular opening of the lumens 124, 125 on the distal ends
of the inner catheters 116, 117, while the catheters nonetheless
have a D-shaped cross-section over a remaining portion of the
catheters that are shown.
[0121] The first inner catheter 116 has a primary lumen 124. A
secondary lumen 126 may also be provided within the first inner
catheter 116. When a second inner catheter 117 is provided, it has
a primary lumen 125, and may also have a secondary lumen 127. The
numbers of lumen in the inner catheters 116, 117 is not limited to
these configurations, and more lumens may be provided.
[0122] The inner catheters 116, 117 may also be provided with
a-traumatic ends 132 that are curved or folded back to be less
traumatic to surfaces inside the patient. Openings to the primary
lumens 124, 125 of the first and second inner catheters 116, 117
may be formed on these a-traumatic ends 132. Additionally,
secondary lumens 126, 127 may open on a side of the inner catheters
116, 117, respectively.
[0123] FIG. 2B shows an opposite-side view of the ventilation
adapter portion 112 shown in FIG. 2A. The flat side 156a of the
first inner catheter 116 and the curved side 157b of the second
inner catheter 117 can be seen in FIG. 2A.
[0124] FIG. 2C shows a top view of the ventilation adapter portion
112 looking down onto the ventilation adapter 154. The inner
catheters 116, 117 may be arranged such that the flat sides 156a
and 157a are facing and proximate to each other. As mentioned
above, the shapes of the inner catheters are not limited to a
D-shape, and other shapes may have different shaped surfaces that
face and/or contact one another. FIG. 2D shows a bottom view of the
ventilation adapter portion 112.
[0125] FIG. 3A shows a sectional view of a portion of the
ventilation adapter portion 112, the sectional view being coaxial
with the ventilation adapter portion 112 and from the section line
3A shown in FIG. 2B. FIG. 3B shows the same portion from an
isometric, side perspective. The key joint component 110 is
disposed within the ventilation adapter portion 112. In the
embodiment shown in FIGS. 3A and 3B, the key joint component 110 is
keyed for first and second inner catheters 116, 117. A key joint
fitting 158 may be provided between the key joint component 110 and
the ventilation adapter portion 112. The key joint fitting 158 may,
for example, help secure the key joint component 110 within the
ventilation adapter portion 112.
[0126] FIG. 4A a view that is coaxial with the fitting 138 of the
ventilation adapter portion 112. FIG. 4B is an alternative
perspective of the portion shown in FIG. 4A.
[0127] FIG. 5 shows the catheter system 100 according to an
embodiment in which only a single catheter (e.g., first inner
catheter 116) is disposed within the system. Except for the
exclusion of a second inner catheter, the parts of the system shown
in FIG. 5 are identical to those in FIG. 1, and descriptions of
those parts will not be repeated here.
[0128] The catheter systems described herein may be utilized as a
single catheter and/or a double catheter. The catheters can be
independently movable proximally and distally. The double catheters
can be independently moveable so that they can each move
independently from the other proximally and distally to reach
different locations. Each can be removed, replaced, and reinserted
independently from the other, as well.
[0129] FIGS. 6A-6D show views of a single catheter embodiment
similar to the views of the double catheter embodiment shown in
FIGS. 2A-2D. Features that were previously discussed will not be
repeated here.
[0130] FIGS. 7A and 7B show views of a single catheter embodiment
with a key joint component 110 that is keyed only for a single
inner catheter 116 according to the single catheter embodiment.
Embodiments with a single catheter 116 are also shown in FIGS. 8A
and 8B.
[0131] An embodiment of the catheter system 100 having two
catheters is shown in FIGS. 9A-9E with the inner catheters 116, 117
in various stages of deployment from the endotracheal tube 114. To
illustrate the positioning of the catheter system 100, the lungs L
of patient P are also shown with the left bronchus B.sub.L and
right bronchus B.sub.R. In FIG. 9A, the catheter system 100 is
shown attached to an endotracheal tube 114 that is inserted into
the trachea T of the patient P. The first and second inner
catheters 116, 117 are shown within the endotracheal tube 114. FIG.
9B shows a close-up view of the endotracheal tube 114 disposed near
the left and right bronchi B.sub.L and B.sub.R. The distal ends of
the inner catheters 116, 117 have been positioned near the opening
at the end of the endotracheal tube 114. As an operator of the
catheter system 100 pushes the inner catheters 116, 117 further
past the distal end 106 of the elongated body 102 (see FIG. 9A),
the inner catheters emerge from the endotracheal tube 114, as shown
in FIG. 9C. As discussed above, the inner catheters 116, 117 may be
shaped to form a V- or Y-shape as they emerge from the confines of
the endotracheal tube 114. This shape can position the inner
catheters 116, 117 to correspond to the branches of the left and
right bronchi B.sub.L and B.sub.R such that one or both of the
inner catheters may be easily positioned into one or both bronchi.
For example, FIG. 9D shows the inner catheters 116, 117 after being
further pushed through the endotracheal tube 114. The first inner
catheter 116 extends toward and into the right bronchus B.sub.R and
the second inner catheter 117 extends toward and into the left
bronchus B.sub.L. One or both inner catheters 116, 117 may be
pushed even farther into the lungs to reach various branches within
the lungs. For example, FIG. 9E shows the first inner catheter 116
positioned farther into the right bronchus B.sub.R.
[0132] The inner catheters 116, 117 can also be rotated while
inserted into the patient, as indicated by the circular arrow in
FIG. 9D. This rotation can be achieved by the operator of the
catheter system 100 rotating the portion of the inner catheter on
the exterior of the patient. This rotation can be used to
facilitate insertion of the inner catheters into the bronchi.
However, in some embodiments, rotation of inner catheters 116, 117
may not be needed because the inner catheters 116, 117 may already
be in desired positions. For example, due to the form or curvature
of the inner catheters 116, 117, they may each be directed to
different bronchi such that one may be used for one bronchus, and
the other for the other bronchus without requiring a rotation. As
indicated by the arrows in FIG. 9E, the inner catheters can each
target smaller lumens within one or both of the bronchi.
[0133] FIG. 9F shows an example of the single catheter embodiment
of the catheter system 100. The inner catheter 116 is shown
inserted into the right bronchus B.sub.R, but the inner catheter
116 could also be positioned into the left bronchus B.sub.L.
[0134] A cross-section of an embodiment of an inner catheter 116 is
shown in FIG. 10. In this embodiment, the catheter 116 has a
D-shaped cross-section, having a curved side 156b and a flat side
156a. The catheter 116 has a primary lumen 124. The catheter 116
may also include a secondary lumen 126 and a tertiary lumen 160. In
some embodiments, the primary lumen 124 can be used to perform
suction, and the secondary and tertiary lumens 126, 160 can be used
for therapeutic agent infusion, including lavage or medicinal
delivery. The catheter is not limited to this configuration and may
have a differently shaped cross-section or more or fewer
lumens.
[0135] The primary lumen 124 may be constructed such that the
distal end can be rounded and a-traumatic, and the proximal end may
be connected to a suction type connector. The secondary and
tertiary lumens 126, 160 may be constructed so that the distal end
can be skived open, rounded, and a-traumatic. An inflation port
could be included through a y-piece and the proximal end thermally
formed to be sealed near the suction connector.
[0136] According to some embodiments, the cross section of the
inner catheter 116 may be based on an extruded polymer shaped like
the letter "D" and may have an oval primary lumen 124 to allow
mucus aspiration and two round secondary and tertiary lumens 126,
160 on each side to give symmetry to the design, as well as
contributing to the torqueability of the cross section in some
embodiments.
[0137] The "D" shape may be used as a key inside a ventilator
adapter and will allow flexibility of the catheter around one axis
of the cross section and the stiffness to maintain the shaped
distal end on the other axis of the cross section. The dimensions
of the D shape according to an embodiment are around 10 mm high and
5 mm width with a minimum oval lumen of 4 mm. However, the
cross-section in FIG. 10 is an example of an embodiment of the
invention. Other cross-section shapes and lumen configurations and
dimensions are also possible according to various embodiments.
[0138] An embodiment of an inner catheter 116 without the elongated
body 102 is shown in FIGS. 11A and 11B. The catheter of this
embodiment includes a curved suction tube (bend 128) with a
proximal end suction adapter/valve (having a wiper seal 142) and
the Y connector fluid connector (irrigation port 152) for the fluid
infusion. The primary lumen 124 may be connected directly to the
suction adapter/valve and the secondary and tertiary lumens 126,
160 may be skived and bonded to the Y adapter to create a luer
infusion port. FIG. 11A shows a top view of the catheter according
to this embodiment. The active length of the catheter of FIG. 11A
may be about 24 inches in some embodiments. The lower projection
shows the orientation of the J shaped tip and the corresponding
orientation of the inflation port at the distal end of the
catheter. FIG. 11C shows a close-up cross-section of the proximal
end of the inner catheter 116 shown in FIGS. 11A and 11B. As shown
in FIG. 11C, the suction adapter/valve is attached to the primary
lumen 124 by skiving off the two secondary lumens and bonding the
single lumen to the suction adapter/valve. The cross section also
shows how the infusion port is attached to the secondary lumen by
partially skiving off the two secondary lumens and bonding the Y
adapter to attach the irrigation port 152.
[0139] FIG. 12 shows another embodiment of an inner catheter 116
with an oval-shaped cross-section. The catheter includes a primary
lumen 124, and may also include secondary and tertiary lumens 126
and 160. The primary, secondary, and tertiary lumens 124, 126, and
160 may have similar uses to the primary, secondary, and tertiary
lumens 124, 126, and 160 discussed above. The cross section of the
inner catheter 116 in this embodiment may be based on an oval
shaped extruded polymer with an oval primary lumen 124 to allow
mucus aspiration and two round lumens 126, 160 on each side of the
primary lumen 124 to give symmetry to the design and to contribute
to the torqueability of the cross section. The oval shape may be
used as a key inside the ventilator adapter and will allow
flexibility of the catheter around one axis of the cross section
and the stiffness helpful to maintain the shaped distal end on the
other axis of the cross section. The dimensions of the D shape may
be around 10 mm high and 7 mm width with a minimum oval lumen of 4
mm, according to one embodiment.
[0140] A representation of an embodiment of the catheter system 100
being used on a patient is shown in FIGS. 13 and 14. In particular,
FIGS. 13 and 14 show how an operator can orient the distal end of
the inner catheter 116 towards the desired bronchi branch by
pointing the keyed ventilation adapter 154 to the desirable
direction in an embodiment of the invention. The catheter 116 may
be inserted through an endotracheal tube 114 and steered to the
target Bronchi using the ventilation adapter 154 on the proximal
end of the catheter 116. In FIG. 13, the inner catheter 116 is
positioned in the right bronchus B.sub.R. As discussed above, the
direction of the bend 128 of the inner catheter 116 can be adjusted
by the operator on the exterior of the patient. In some
embodiments, the torqueability of the catheter 116 can confirm
corresponding orientations between the infusion port and the bend
128 of the distal end of the catheter 116. For example, the
ventilation adapter 154 can be configured to point in the same
direction as the inner catheter 116. By turning the ventilation
adapter portion 112, the direction of the ventilation adapter 154
can point in different directions. Additionally, due to the keyed
joint formed by the key joint component 110 and the inner catheter
116, the rotation of the ventilation adapter portion 112 will
correspond to a rotation of the inner catheter 116 positioned
within the patient, according to some embodiments. For example,
FIG. 13 shows the ventilation adapter 154 and bend 128 of the inner
catheter pointing in the same direction with respect to the body of
the inner catheter 116. When the ventilation adapter 154 is turned
to point in the opposite direction, as shown in FIG. 14, the inner
catheter 116 also turns to point in the opposite direction.
Accordingly, an operator of the catheter system 100 can easily
adjust the inner catheter 116.
[0141] FIGS. 15A and 15B show an inner catheter 116 according to an
embodiment with one example of a possible shape of the bend 128.
FIG. 15C shows a close-up of the end of the catheter 116 with a tip
formed as an a-traumatic end 132 surrounding the lumen 124. As
shown in FIGS. 33A and 33C, for example, X-Ray radiopaque marker
band 232 may be attached to the distal end of the catheter 116 to
allow visualization under X-Ray. For example, the catheter 116 (or
primary lumen 124) may be folded over the marker band and reflowed
to secure the marker band to the catheter. FIG. 15D shows a close
up of the proximal end of the catheter according to this
embodiment. The shape of the bend 128 is not limited to the example
shown in FIG. 15B.
[0142] FIGS. 15E-15H show various shapes of the distal end of the
of the catheter 116. In each example, the bend is formed having a
first radius of curvature r.sub.1', r.sub.2', r.sub.3', and
r.sub.4', and also a second radius of curvature r.sub.1'',
r.sub.2'', r.sub.3'', and r.sub.4''. The combination of two curves
may be referred to herein as a compound bend or compound curve. In
the dual inner catheter embodiments, the inner catheters 116, 117
may have the same or different combination of radii r.sub.i' and
r.sub.i''. The compound curve of the bend 128 may improve suction
and optimize navigation into one or both lungs to efficiently
aspirate mucus from one or both lungs
[0143] FIG. 16A shows an example of the ventilation adapter portion
112 according to an embodiment. In FIG. 16B, a sectional view taken
from the dashed line 16B in FIG. 16A reveals the key joint
component 110. In this example, the key joint component 110 is
keyed for two catheters. A close-up of the key joint component 110
is shown in FIG. 16C. FIG. 16D shows a view looking into the
ventilation adapter portion 112. The key joint component 110 with
spaces for two inner catheters.
[0144] A single inner catheter 116 embodiment is shown in FIGS. 17A
and 17B, with the inner catheter 116 being inserted through an
endotracheal tube 114. The key joint component 110, as shown in
FIG. 17B, is keyed for a single catheter. FIG. 17C shows an
alternate embodiment of a single catheter system.
[0145] A two inner catheter embodiment is shown in FIG. 18A, with
both catheters 116, 117 inserted through a single endotracheal tube
114. The key joint component 110 in this example is keyed for two
D-shaped inner catheters. D-shaped first and second inner catheters
116, 117 are shown in FIGS. 18C and 18D. In embodiments where the
catheters have a different cross-sectional shape, the key joint
component may also have a different configuration such that the
inner catheters pass through holes in the key joint component that
have a shape corresponding to that of the catheter
cross-sections.
[0146] FIGS. 19 and 20 show examples of how the catheter system can
be handled and operated by a user of the system. In FIG. 19, a hand
of the user grips the system near the fitting 138 of the
ventilation adapter 154. The ventilator adapter allows artificial
respiration. While the catheters 116, 117 are introduced through
the top port adjacent to the ventilator adapter 154, the
ventilation adapter 154 is connected to the artificial respiratory
system that can allow a continuous flow of air through the
endotracheal tube 114, for example. The user is holding the system
such that the ventilation adapter 154 pointing in the direction
shown. Due to the keyed joint, the direction in which the distal
ends (not shown) of the inner catheters 116, 117 are pointed can be
known and controlled even when the distal ends are inside the
patient. In FIG. 20, showing a single catheter embodiment, the
ventilation adapter 154 is pointed in an opposite direction to that
shown in FIG. 19.
[0147] FIGS. 21-24 show an embodiment of the catheter system with a
single inner catheter 116. The system is shown without an
endotracheal tube connected to the fitting 138. As discussed above,
the system can be configured such that the direction in which the
ventilation adapter 154 points corresponds to a direction of the
orientation of the inner catheter 116 (see FIGS. 22 and 23).
Although in these examples the ventilation adapter 154 is used to
indicate the orientation of the inner catheter 116, other
embodiments are possible. For example, the orientation of the inner
catheter can be indicated by another structure or indicator on the
system that is external to the patient when the system is in use,
such as a marking or other structural feature. The embodiments
shown in FIGS. 21-24 show a so-called "closed system" which uses
the flexible envelope 140 to keep the catheter 116 in a closed
environment to segregate it from the operator for contamination
control. However, embodiments are not limited to closed-systems,
and may include systems without flexible envelope 140. FIG. 24
shows the valve 146 at the proximal end of the catheter 116
according to an embodiment. This valve 146 can be opened or closed
to control the application of suction to the catheter 116 using the
primary lumen of the shaft. In a closed system, the valve 146 may
have a top or covering that is depressed by an operator of the
catheter to control suction. In this way, the valve 146 keeps the
interior of the catheter system closed and separated from the
operator. Next to the valve 146 there can be an infusion port 152
for administrating fluids through the catheter 116 using, for
example, one or more secondary lumens of the catheter 116.
[0148] In some embodiments, the catheter 116 is a so-called "open
system." FIGS. 15B and 15D, for example, show an embodiment of an
open system. The valve 146 in an open system may be an open valve
(see FIG. 15D), which is controlled by the operator placing, for
example, a thumb over the top of the top valve to control suction.
When the top of the open valve is covered (e.g., with a thumb)
suction will be performed through the catheter, but when the valve
is uncovered, suction will cease. The level of suction may also be
controllable by the degree to which the open valve is covered or
uncovered. An open system may be provided with or without the
flexible envelope surrounding the catheter.
[0149] The valve is usually of a kind having a flow control
positioned lateral to the flow path and having two distinct
positions where flow is either enabled or disabled
[0150] In the some embodiments discussed herein, the orientation of
the inner catheter may be known and/or controlled even when inside
the patient due in part to the keyed joint formed by the key joint
component 110 and the one or more inner catheters. The inner
catheters may have structural or material properties to ensure a
correspondence between the orientations of the one or more inner
catheters near the keyed joint and at the distal ends of the
catheters. For example, the inner catheters may exhibit a 1:1
torqueability ratio along the length of the inner catheter, or at
least along a portion of the inner catheter extending from the key
joint component 110 to the distal end 122, 123 of the inner
catheters 116, 117 in an operating position inside the patient.
According to the 1:1 torqueability ratio, a turning or rotating of
the one or more inner catheters at the key joint component 110 will
result in an equal amount of turning or rotation of the distal ends
of the one or more catheters. In other words, a torque at a first
end of the catheter will result in an equal degree of rotation at
both the first end and a second end, the second end being an
opposite end from the first end. Therefore, the orientation of the
distal end of a catheter may be known based on the orientation of
the catheter on the proximal end, which may be external to the
patient. As discussed above, the orientation of the catheter on the
exterior of the patient may be indicated by, for example, the
orientation of the ventilation adapter 154 or some other
indicator.
[0151] In some embodiments, rotating the proximal end of the inner
catheter may result in the inner catheter twisting over at least a
portion of its body due to the tortuosity of the inner catheter
when the distal end is inserted into a body lumen (e.g., trachea).
Thus, the inner catheter, while in a curved configuration due to
the anatomy of the body, may twist such that the orientation of the
proximal end may not correspond to the orientation of the distal
end. Nonetheless, the inner catheter may still be considered to
have "1:1 torqueability" consistent with the definition used
herein, because the catheter, while in a straight configuration
(i.e., not confined by the body lumen) may exhibit the 1:1
correspondence between distal and proximal ends when the proximal
end is rotated.
[0152] This 1:1 torqueability ratio may overcome a potential
problem in catheters where the disposition (e.g., degree of
rotation) of the distal end of a catheter may be unknown when the
distal end is inside the body lumen. For example, a catheter may
have a distal end disposed in any one of several ways (e.g., any
degree of rotation) and the change in disposition of the distal end
in response to a rotation of the proximal end of the catheter may
be unknown. Specifically, there may be no degree of rotation or
disposition of the proximal end that will reliably ensure a given
degree of rotation or disposition of the distal end of the
catheter. For example, in some catheters, a twist at a proximal end
of a catheter may produce no change at the distal end of the
catheter, or may produce a rotation at the distal tip that bears no
or unreliable relation to the proximal rotation, as described
above. Thus, a change at the distal end will produce a different
degree of rotation and thus cause unreliable performance for the
user. In other words, reliable use of some catheters may be
difficult to achieve because the position or orientation of the
distal end cannot be reliably known by the user based on
controlling or manipulating the proximal end. Regarding these
challenges, embodiments of the current invention may offer improved
performance.
[0153] The inner catheters may be made of, for example,
polyvinylidene fluoride or polyvinylidene difluoride (PVDF), which
is highly non-reactive thermoplastic fluoropolymers produced by the
polymerization of vinylidene difluoride. Kynar.TM. is one example
of such a material. The 1:1 torqueability may be achieved by the
inner catheter being formed from a rigid material having properties
that include, for example, one or more of the following: (1) a
Shore D hardness of about 55.0 to 60.0; (2) an ultimate tensile
strength of about 4000 to 6000 psi; and (3) a yield tensile
strength of about 1700 to 2800 psi. However, other material
properties or combinations of properties may also achieve or
contribute to 1:1 torqueability. Additionally, the inner catheter
may be formed to have a cross-section that provides, for example, a
high polar moment of inertia, indicating the ability of the shaft
to resist torsion in an embodiment of the invention, and which is
required to calculate the twist of a shaft subject to torque. In
certain embodiments, the cross-section may include a flat
portion.
[0154] The following discussion uses simplified equations that are
representative of general principles of structural and material
behavior. Some of the equations below depend on physical geometry
of a member (i.e., catheter). Embodiments of the invention include
various geometries which may not be exactly described by the
equations below. Thus, aspects (e.g., geometry) of embodiments of
the invention are not meant to be limited by the geometries implied
by any of the below equations. Nonetheless, the general principles
below are applicable to design considerations of embodiments of the
current invention.
[0155] Catheter torqueability describes the behavior of a catheter
when a moment of torque is placed about its longitudinal axis. For
small deflections, the catheter's mechanical properties approximate
a spring system in which torsional stiffness is determined such
that:
k torq = GJ L ##EQU00001##
where k.sub.torq is the torsional spring constant, G is the shear
modulus, J is the polar moment of inertia, and L is the length of
the catheter shaft. Maximizing torqueability means maximizing the
quantity k.sub.torq, which can be accomplished by any of the
following three ways: [0156] (1) maximizing the polar moment of
inertia. For a single tube profile, the governing equation for J is
as follows:
[0156] J = .pi. 32 ( d o 4 - d i 4 ) ##EQU00002## where d.sub.o is
the tube outer diameter and d.sub.i is the tube inner diameter. In
order to maximize J, the designer needs to maximize the outside
diameter and the wall thickness; [0157] (2) maximizing the shear
modulus by using a stiffer material; or [0158] (3) decreasing the
overall length of the shaft.
[0159] Flexibility for a simple tube can be modeled as a clamped
beam system subject to a downward force at the beam. For small
deflections, the tubing approximates a spring system, with the
flexural stiffness determined by:
k flexural = 3 EI L 3 ##EQU00003##
where k.sub.flexural is the flexural spring constant, E is the
modulus of elasticity, I is the moment of inertia, and L is the
length of the catheter shaft. In many cases, it is desirable to
minimize the flexural stiffness of the catheter, which may be done
by minimizing the quantity k.sub.flexural, which can be
accomplished by, for example, one of the following three ways:
[0160] (1) minimizing the moment of inertia. For a cylinder, the
governing equation for the moment of inertia is:
[0160] I = .pi. 64 ( d o 4 - d i 4 ) ##EQU00004## Where d.sub.o is
the tube outer diameter and d.sub.i is the tube inner diameter. In
order to minimize I, the outer diameter and the wall thickness may
be minimized; [0161] (2) minimizing the modulus of elasticity by
using a soft material; and [0162] (3) increasing the overall length
of the shaft.
[0163] Composite tubing designs may be used for catheter delivery
systems. These may include one or more plastic materials as well as
wire-reinforced (braid or coil) designs. The modeling concepts
described previously can also be used to analyze and compare
composite tubing designs. The stiffness properties of each separate
and distinct layer can be computed and combined using principles of
classical lamination theory.
[0164] The aspiration catheter system may be a sterile, single-use,
disposable device whose primary purpose is to blindly but
accurately deliver suction tubes to the left and right bronchi
through the endotracheal tube. The secondary purpose of the
catheter system is to provide a second channel in order to
administer therapeutic agents to the airways. The second channel
prevents these agents from mixing with the fluids removed from
lungs. The second channel may also be used for lavage.
[0165] An intended use of the aspiration catheter system can be to
remove fluids and mucus that congest the airways. The system allows
the accurate introduction of suction tubes into the left and right
bronchi without the use of visual guidance. Removing the fluids
will ameliorate the symptoms of pneumonia, improve breathing and
overall lung function, thereby accelerating the patient's
recovery.
[0166] The aspiration catheter system may use multi-lumen shaped
suction tubes inserted through an off-the-shelf-endotracheal tube
using a keyed ventilation adapter. The combination of pre-shaped,
keyed suction tubes inside an off-the-shelf endotracheal tube
allows the physician to insert the tracheal tube using standard
techniques. Once positioned, one or two suction tubes are deployed
from the distal end of the endotracheal tube and form a bifurcated
shape that directs these tubes in left and right bronchi. The
catheter system allows efficient and sterile delivery of
therapeutic agents through a dedicated lumen to avoid
contamination.
[0167] The catheter system can be used in conjunction with a
commercially available stethoscope to confirm the location of both
suction tubes, and by listening to the fluid suction noises, the
operator can confirm the suction tubes were properly deployed into
both primary bronchi.
[0168] Increasingly, modern medicine demands devices that can
navigate narrow passageways to a desired location within a body so
that diagnostic and therapeutic procedures can be performed.
Currently, elongated medical devices such as catheters can extend
into the body via an access point through various connected
passageways to a target location. Though these approaches are
common in cardiac and vascular disease, they have not been well
applied in pulmonary disease.
[0169] The respiratory tract is an example of a tortuous pathway.
The respiratory tract begins at the nose and mouth, which open to
the trachea. The trachea travels downward into the chest and it
splits into the left and right main bronchi. The left and right
main bronchi split at an angle from the trachea. The left main
bronchus is smaller in diameter and branches at a greater angle
from the trachea than the right main bronchus. The main bronchi
then split into lobar bronchi, which split into segmental bronchi.
The segmental bronchi split into subsegmental bronchi.
[0170] Several procedures require intubation of the respiratory
tract, including the left and right main bronchi, to aspirate mucus
in the lungs or to deliver localized medicine. Intubation of the
left main bronchus from the trachea can be difficult because it can
have a smaller diameter and greater angle relative to the trachea.
For example, a typical procedure for aspirating fluid from the
lungs can include introducing an endotracheal tube to the trachea
of a patient, followed by extending a working catheter (e.g., an
aspiration catheter) through a lumen of the endotracheal tube and
into either the right or left main bronchus. Respiratory therapists
seeking to intubate the left main bronchus with the aspiration
catheter may mistakenly believe the left main bronchus has been
intubated, when the catheter has actually entered the right main
bronchus instead. In some instances, the endotracheal tube can be
mistakenly inserted too deep so that its distal end extends into
the right main bronchus, whereby the aspiration catheter can only
access the right main bronchus. Often times, a specialist, such as
a pulmonologist, is needed to insert a bronchoscope into the left
main bronchus and aspirate the left main bronchus using the working
channel of the bronchoscope. The bronchoscope is equipped with a
vision system (including, for example, a fiberoptic system) and/or
a fluoroscopic imaging system, to guide the bronchoscope into the
left main bronchus. However, visualization equipment and the
endoscopic procedure can be expensive, and specialists may not be
readily available to conduct the procedure when desired.
[0171] Closed system suction catheter assemblies are used for
removing secretions from within the trachea or bronchi of an
intubated patient. The assembly comprises a flexible catheter
connected at its distal end to the proximal end of an endotracheal
tube. The proximal end of the flexible catheter is connected with a
fitting, including a valve, that can be opened or closed to control
the application of suction to the catheter. The valve is usually of
a kind having a flow control positioned lateral to the flow path
and having two distinct positions where flow is either enabled or
disabled.
[0172] Towards its distal end, the catheter extends through a
fitting connected between the end of a tracheal tube and a
ventilation circuit. The catheter can be advanced through the
fitting down the tracheal tube to enable suctioning. A flexible
envelope extends between the two couplings, enclosing the catheter
so that it can be manipulated through the envelope. A wiper seal in
the forward coupling prevents gas from the ventilation system
inflating the envelope.
[0173] In some assemblies, provision is made for cleaning the
catheter after its patient end has been withdrawn into the forward
coupling. A manually-operable valve is located forward of the wiper
seal providing a cleaning chamber between the valve and the wiper
seal. An irrigation port opens into this chamber so that saline can
be supplied to it, which is then drawn along the bore of the
catheter by the applied suction to remove matter collected within
the bore.
[0174] According to the above embodiments in which two or more
inner catheters are provided, each inner catheter may be slideable
independent of the other inner catheters. For example, the extent
to which a first inner catheter extends out of the catheter system
or an endotracheal tube can be adjusted independently of the extent
to which a second inner catheter is extended. This may allow for
independently targeting the left or right bronchus, or lumens
within one of the bronchi. In an embodiment, at least a portion of
two or more inner catheters may be housed within a lubricious
sleeve 162, as shown in FIG. 25. The lubricious sleeve 162 can help
facilitate the sliding of one or more of the inner catheters in
and/or out of the catheter system during use. The lubricious sleeve
162 may be a lubricious double lumen sleeve with inner catheters
being separately housed in different lumens of the double lumen
sleeve. In the double lumen configuration, the lubricious sleeve
162 may allow, for example, the position of one inner catheter in
one lumen of the double lumen sleeve to be adjusted without
interfering with the position of another inner catheter in the
other lumen of the double lumen sleeve.
[0175] FIG. 26A shows a catheter 200 according to an embodiment of
the invention. The catheter 200 has a proximal end 203, a distal
end 205 that may include a pre-formed curve, and an elongated body
207 extending between the proximal and distal ends 203, 205. In the
embodiment shown in FIG. 26A, the distal end 205 has a compound
curve comprising two curves, with one curve having a radius of
curvature of r' and the other curve having a radius of curvature of
r''.
[0176] FIG. 26B shows a distal end of a catheter 200 according to
an embodiment of the current invention. The catheter 200 includes a
pre-formed curve 202. In a preferred embodiment, the pre-formed
curve 202 includes a first curve 204 and a second curve 206,
examples of which are shown in FIG. 26B, though embodiments are not
limited to this configuration and may include one or more curves.
The pre-formed curve 202 may have radii of curvature corresponding
to those discussed above. The catheter 200 may include a first
opening 208, a second opening 210, and a third opening 212. Each of
the first, second, and third openings 208, 210, and 212 correspond
to separate lumens (not shown in FIG. 26B, but see FIG. 27 and FIG.
30B showing a cross-sections of catheter 200 including three
lumens) within the catheter 200. For example, opening 208 opens to
the first lumen 226 (see FIG. 30B). However, the first lumen 226
may be provided with multiple openings, including three openings
208a, 208b, and 208c in some embodiments, as discussed further
below. (See, e.g., FIGS. 34A-34F).
[0177] As discussed above, each lumen can be configured to perform
multiple functions. In one embodiment, the first opening 208 may be
configured to perform a suction function. Additionally, second and
third openings 210 and 212 may perform suction or other functions,
such as lavage, for example. The location of each opening relative
to the distal tip 201 of the catheter 200 and relative to each
other can have certain advantages according to embodiments of the
invention. For example, if an opening performing suction and an
opening performing irrigation are too close to each other, the
fluid leaving the irrigation hole may be immediately taken in by
the opening performing suction, which can minimize the effect of
the irrigation and/or suction. If the fluid used for irrigation is
suctioned before washing a sufficient portion of the anatomy, for
example, the irrigation function may be negatively impacted.
However, with sufficient spacing between the respective openings,
this negative effect can be reduced or minimized by allowing the
fluid from the irrigation opening to wash a larger area of the
anatomy before being suctioned. An additional advantage of
staggering the openings 208, 210, and 212 along a length of the
catheter 200 is that the number of openings in any one subdivision
of that portion is reduced. For example, in FIG. 26F, openings 210
and 212 are positioned at different points along the catheter 200.
This may increase structural integrity of the catheter and decrease
the chance that the catheter kinks during use.
[0178] Accordingly, in some embodiments, opening 208a may be a
distance d.sub.1 from the distal tip 201; opening 210 may be a
distance d.sub.2 from opening 208a; and opening 212 may be a
distance d.sub.3 from opening 210, where distances d.sub.1,
d.sub.2, and d.sub.3 are linear dimensions measured in a direction
parallel to the x-axis (see FIG. 26E). The x-axis may be parallel
to the longitudinal axis (corresponding to line L.sub.2) of the
elongated body of the catheter 200. It is also understood that, due
to the curvature of the distal end, the values of d.sub.1, d.sub.2,
and d.sub.3 may result in varying vertical distances (i.e.,
parallel to the y-axis) between the openings. Further, values of
d.sub.1, d.sub.2, and d.sub.3 can be constant across catheters of
different curvatures while resulting in different spacings in the
y-direction, and vice versa. In one example, d.sub.1 can be about 7
mm, d.sub.2 can be about 5 mm, and d.sub.3 can be about 15 mm. In
the above discussion, d.sub.1 is referred to as the distance
between the distal tip 201 and opening 208a. The distance between
opening 208b and the distal tip 201 may also be d.sub.1 or may be a
different distance.
[0179] In addition to the staggered spacing of openings 208, 210,
and 212, as shown in FIG. 26E, for example, the direction in which
the openings 208, 210, and 212 can also be varied. For example,
with reference to FIG. 26E, opening 208 faces in a direction
parallel to the z-axis, while openings 210 and 212 both face
different directions from that of opening 208. Additionally,
openings 210 and 212 can face directions that are substantially
opposite to one another. For example, in FIG. 26E, opening 210
faces a direction a.sub.1 that is at an angle .gamma..sub.1 to a
line parallel to the y-axis. In contrast, opening 212 faces a
direction a.sub.2 that is at an angle .gamma..sub.2 to a line
parallel to the y-axis. According to some embodiments,
.gamma..sub.1 and .gamma..sub.2 may be substantially equal in
magnitude, but they may be different in magnitude according to
other embodiments. For example, .gamma..sub.1 and .gamma..sub.2 may
be determined, at least in part, by the amount of curvature in each
curved portion of the compound curve of the catheter 200, as well
as by the location of each opening 210, 212 along the length of
each curved portion. Additionally, by facing openings 210 and 212
in different directions, perhaps substantially opposite directions
in some embodiments, irrigation or the dispensing of therapeutic
agents may be directed in either direction, as needed, or in both
directions to treat a larger area or volume of the anatomy.
[0180] FIG. 26E also shows that the distal tip 201 may be curved
slightly upward at angle .theta. relative to a line (L.sub.1) that
is parallel to the x-axis. For reference, line L.sub.2 corresponds
to a longitudinal axis of the catheter, and line L.sub.2 is shown
parallel to the x-axis and L.sub.1. This configuration of the
distal tip 201, along with the compound curve of the bend, can help
the catheter 200 to be pushed through a Murphy's eye of a delivery
catheter in a relatively unobstructed manner. The distal tip 201
may also have an opening 208c to the first lumen 226 and have a
beveled edge. The beveled edge may minimize trauma to tissue and/or
may be formed when closing off the second and third lumens 228, 230
of the extrusion. Alternatively, the distal tip 201 may be closed
so that there is no opening.
[0181] Additionally, the direction and location of openings 208,
210, and 212 can be specified relative to a particular surface of
the catheter 200. In FIGS. 26B-26F, for example, opening 208 is
formed on a curved surface 216 of the catheter 200. In other
embodiments, opening 208 may be formed on the flat surface 214 (see
FIG. 26F).
[0182] The spacing of openings 208, 210, and 212 in FIGS. 26B-26F
is an example of one embodiment, but embodiments of the current
invention are not limited to the spacing shown. The openings 208,
210, and 212 can, for example, have greater or smaller spacing
and/or face different directions from the catheter than the
directions shown. Although three openings 208, 210, and 212 are
shown in FIGS. 26B-26F, more or fewer openings may be present
according to various embodiments of the invention.
[0183] Placement of the openings 208, 210, and 212 relative to the
pre-formed curve 202 can also have certain advantages. For example,
the second and third holes 210 and 212 in FIG. 26B are each formed
on the inside curves of first and second curves 204 and 206,
respectively. This arrangement may protect the anatomy of a patient
by reducing the likelihood that holes 204 and 206 will be placed in
immediate contact with tissue of the patient during use. For
example, the tissue may be traumatized by the edges of holes
scraping against the tissue. However, the positioning of the second
and third openings 210 and 212 on the inside of curves 204, 206
decreases the likelihood that the openings 210, 212 will scrape the
tissue. Accordingly, trauma to the issue caused by scraping of the
opening edges is reduced. Additionally, fluid inflow (i.e.,
suction) or fluid outflow directly against the tissue can be
reduced, which may also reduce trauma to the tissue.
[0184] Furthermore, positioning the first opening 208 distal to the
pre-formed curve 202 (i.e., reducing the distance between the first
opening 208 and the distal tip 201) can reduce a moment at the
first opening 208 during, for example, suction, and thus, the
likelihood of the catheter collapsing is reduced. The distal tip
201 may have a beveled or folded edge to be a-traumatic. FIG. 27
shows a cross-section the catheter 200 according to an embodiment
of the present invention. The general shape of the cross-section in
FIG. 27 is a D-shape, having a first side 214 that is flat with a
normal N and a second side 216 that is curved. However, embodiments
are not limited to this specific shape. For example, some
embodiments may have a first side that is flat, while a side
opposite to the flat side may be curved (as in FIG. 27, or with a
different curve) or flat. In one embodiment, the cross-section has
a relatively flat, substantially rectangular "ruler" shape. The
dimensions of various aspects of the cross-section can affect the
response (i.e., the "binary response") of the catheter according to
some embodiments by changing, for example, the polar moment of
inertia or other properties. For example, as shown in FIG. 27, the
cross-section may have a width w.sub.1, height h.sub.1, and curved
transitions with radii R.sub.1 between the curved and flat sides
216, 214. The catheter cross-section may also have a primary lumen
with a width w.sub.2, a height h.sub.2, and curved portion with
radius R.sub.3. Secondary lumens may be spaced from the primary
lumen at a distance of d.sub.1 and may have radii of R.sub.2.
[0185] Some embodiments of the invention include a catheter that
may be inserted into a body lumen of the patient by passing the
catheter through a delivery lumen, such as an endotracheal tube. In
some of these embodiments, there may be contact between the
catheter and the delivery lumen, and that contact may effect or
contribute to the binary response of the distal end of the
catheter. FIGS. 28A-28E show schematics of catheters 200 while
inserted into an endotracheal tube 218 according to some
embodiments. The curvature of the catheter 200 and endotracheal
tube 218 is dictated by the anatomy of the body lumen. The catheter
200, for example, is flexible enough to curve when inserted through
the endotracheal tube 218. The endotracheal tube 218 can be
considered to have a first wall 220 and a second wall 222, as shown
in FIG. 28A. According to embodiments of the current invention,
when the catheter 200 is placed within the endotracheal tube 218,
the first wall 214 of the catheter may contact the first wall 220
of the endotracheal tube, and the second wall 216 of the catheter
may contact the second wall 222 of the endotracheal tube. However,
in some embodiments, only one of the first and second walls 214,
216 of the catheter 200 may contact a wall of the endotracheal
tube. The orientation of catheter 200 in FIG. 28A may be considered
to be a first orientation of the catheter. By rotating the catheter
200 at the proximal end about the longitudinal axis of the catheter
200 while inserted in the endotracheal tube 218, the catheter 200
may achieve a second orientation in which the first wall 214 of the
catheter is contacting or facing the second wall 222 of the
endotracheal tube and the second wall 216 of the catheter is
contacting or facing the first wall 220 of the endotracheal tube
(see FIG. 28E, for example). Points of contact between the catheter
200 and the endotracheal tube 218 are indicated by a, b, and c in
FIG. 28A-28E. FIGS. 28A-28E demonstrate the various combinations of
points of contact possible between the catheter 200 and the
endotracheal tube 218 according to various embodiments.
[0186] For example, in FIG. 28A, one side of the catheter 200
(e.g., the flat side 214, as shown, but in some embodiments either
side of the catheter 200 may be facing either direction) is
touching one point b1 of the endotracheal tube 218, and the other
side (e.g., the curved side 216, as shown) is touching two points
a.sub.1 and c.sub.1 of the endotracheal tube 218. However,
depending on the properties of the catheter 200 and the curvature
of the endotracheal tube 218 or the anatomy of the patient, the
catheter 200 may contact the endotracheal tube according to a
number of arrangements. In FIG. 28B, for example, one side of
catheter 200 is not touching the endotracheal tube 218, while the
other side of the catheter is touching at two points of contact
a.sub.2 and b.sub.2. In FIG. 28C, there is one point of contact
a.sub.3 on a first side of the catheter, but no points of contact
on the second side, while in FIG. 28D there are no points of
contact on the first side and one point of contact a.sub.4 on the
second side. Finally, as yet another example, there are two points
of contact a.sub.5, c.sub.5 on the first side of the catheter and
one point of contact b.sub.5 on the second side. In some
embodiments, a catheter may have a configuration from one of FIGS.
28A-28E when the catheter is in a first orientation, and the
catheter may have one of the other configurations from FIGS.
28A-28E, or the same configuration, when rotated 180.degree. to a
second orientation. These configurations are examples of some
embodiments, but embodiments of the invention are not limited to
these configurations.
[0187] Some embodiments of the current invention, due to a variety
of the above-discussed features, exhibit a unique and advantageous
response during use due to the unique combinations of features
described herein. An embodiment of a catheter having this response
is shown in FIGS. 29A-29E. Specifically, when inserted into a body
lumen of a patient, a catheter may be in a first orientation (FIG.
29A, for example). A rotation of the proximal end of the catheter
may then produce a binary response at the distal end of the
catheter. "Binary response," as used herein, means that the distal
end of the catheter is capable of two resting positions or
orientations, such that the distal end of the catheter is in one of
those two resting orientations at any given time. More
specifically, when inserted into a body lumen of a patient
(including possibly through a delivery lumen such as an
endotracheal tube), a proximal end of the catheter may be rotated
by an operator of the catheter from a first orientation (FIG. 29A,
for example) to a second orientation (FIG. 29C, for example). Over
a range of degrees of rotation .alpha..sub.1 at the proximal end of
the catheter, the distal end of the catheter will remain in a first
orientation, substantially without rotating (see FIG. 28B and FIG.
28D). However, upon achieving a predetermined degree of rotation
.alpha..sub.2 at the proximal end, the distal end of the catheter
will respond by "flipping" from the first orientation to the second
orientation (see FIG. 29C and FIG. 29E, for example). The second
orientation of the distal end may be an approximately 180.degree.
rotation from the first orientation of the distal end. Because the
distal end remains in one orientation while the proximal end is
rotated through a range of degrees of rotation, some twisting of
the elongated body of the catheter will occur before the flipping
of the distal end. This twisting is shown in FIGS. 29B and 29D, for
example. For example, FIGS. 29B and 29D each show both side s.sub.1
and s.sub.2 of the catheter. Because s.sub.1 and s.sub.2 are
different or opposite sides of the catheter, the visibility of both
sides s.sub.1, s.sub.2 in those figures indicates a twisting of the
catheter. The twisting shown in FIGS. 29B and 29D is only to
symbolically indicate that twisting occurs and may not be
representative of the actual appearance of twisting during use of a
catheter according to these embodiments. According to some
embodiments, the rotation necessary at the proximal end of the
catheter to achieve this response at the distal end of the catheter
is at least 90.degree.. According to other embodiments, the
rotation necessary at the proximal end is at least 135.degree., or
at least 150.degree., or approximately 180.degree.. Although the
"flipping" of the distal end of the catheter means that the
catheter may pass through a range of degrees, the distal end
nonetheless may have only two resting orientations. Therefore, the
"flipping" does not contradict the "binary response" described
above.
[0188] According to the above described flipping, a proximal end of
a catheter that is taken from a first orientation and twisted or
rotated to a degree that is not sufficient to achieve the flip will
result in the proximal end returning to the first orientation when
the applied torque is removed. Due to the 1:1 torqueability of the
catheter, an operator of the catheter will know the orientation of
the distal end based on the orientation of the proximal end.
Therefore, in this example, the return of the proximal end to the
first orientation will indicate to the operator that the flip has
not occurred, and that the distal end orientation corresponds to
the proximal end orientation. In contrast, when the torque at the
proximal end produces a degree of twisting or rotation that is
sufficient to produce the flip, the distal end will flip to its
second orientation (e.g., approximately 180.degree. from its first
orientation). With the distal end in its second orientation, the
proximal end will also move to its second orientation
(corresponding to the distal ends second orientation due to 1:1
torqueability) when the torque at the proximal end is no longer
applied, if not already in the second orientation.
[0189] According to embodiments of the current invention, the
factors that contribute to the binary response of the distal end of
the catheter may include: the catheter cross-section (including
having one substantially flat side); the structural dimensions of
the catheter (including wall thickness, length of catheter, lumen
configuration, and other features); material properties of the
catheter material (including hardness, stiffness/torsional
stiffness, elastic modulus, ultimate and yield tensile strength);
and composition of the catheter material.
[0190] According to some embodiments, a catheter capable of
achieving the above-described binary response may also exhibit 1:1
torqueability when not inserted into a body lumen of a patient.
[0191] According to some embodiments of the current invention, a
binary response catheter is provided which has a pre-formed curve,
as discussed above and shown in FIGS. 26B and 31A-31C, for example.
The pre-formed curve may be formed such that that catheter may
curve toward one of the left and right bronchi when the distal end
of the catheter is in the first orientation. When the distal end of
the catheter flips to the second orientation in accordance with the
binary response, the distal end may then be curved toward the other
of the left and right bronchi. Thus, there is a relationship
between the direction of the pre-formed curve and the orientation
of the first and second orientations of the distal end of the
binary response catheter. Accordingly, a catheter may be provided
that enables more confident placement of the distal end of the
catheter in one of the left and right bronchi, as well as easy and
reliable switching of the distal end between the left and right
bronchi.
[0192] FIG. 30A shows a bottom view of the catheter 200 and FIG.
30B shows a cross-section view of the catheter 200 taken along line
A-A in FIG. 30A. According to some embodiments, the catheter 200
may include a first lumen 226, a second lumen 228, and a third
lumen 230. From the bottom view in FIG. 30A, the opening 208a of
primary lumen 124 can be seen on the curved surface 216, and the
opening 212 of the tertiary lumen 160 can be seen. From the
cross-sectional view of FIG. 30B, each of the first, second and
third lumens 226, 228, and 230 are clearly visible. Openings 208b
and 208c of the first lumen 226 are also visible in FIG. 30B, the
opening 208b being on the flat side 214 of the catheter 200. In the
embodiment shown, the second and third lumens 228 and 230 extend
substantially along the entire length of the catheter 200 due to
ease in manufacturing of the extrusion. Openings 210 and 212 are
opened on the second and third lumens 228, 230, respectively, by
the wall of the catheter 200 adjacent to those lumens being skived
or opened. The second and third lumens 228, 230 are closed near the
tip of the catheter by a pinching or folding of the tip, for
example. Thus, only the opening 208c opens on the end tip 201 of
the catheter 200.
[0193] The pre-formed curve of the catheter also has the advantage
of successfully navigating the distal end of the catheter through a
Murphy's eye, which may be found on the distal end of a delivery
catheter or endotracheal tube, for example. Thus, the catheter may
have improved usability over known catheters, which may be
obstructed by the Murphy's eye when, for example, an opening on a
catheter or a tip of a catheter makes contact with the structure of
the Murphy's eye. FIGS. 32A-32E shows an example of a catheter 200
with a pre-formed curve according to an embodiment of the present
invention passing through a Murphy's eye 224. Advancement of the
position of the catheter can be seen from in the sequence of
positions from left to right in FIGS. 32A-32E. By positioning the
openings 210 and 212 on the inner curves of the compound curve, the
catheter 200 may more easily slide past the Murphy's eye. For
example, due to the curvature of the catheter in embodiments of the
invention, the edges of openings 210 and 212 may be prevented from
rubbing against the Murphy's eye. In some embodiments, only the
outer curves of the compound curve may slide against the structure
of the Murphy's eye.
[0194] FIGS. 33A-33D show four perspective views of the distal end
of the catheter 200 according to an embodiment of the invention.
FIG. 33A is a bottom view of catheter 200 with the flat side 214
having a normal vector out of the page and an opening 208b. FIG.
33B is a side view showing the relationship of opening 212 and
opening 208a to the curved side 216 and flat side 214. FIG. 33C
shows a top view of the catheter with a curved side 216, opening
208a, and the distances d.sub.1, d.sub.2, and d.sub.3 between
distal tip 201 and opening 208a, between openings 208a and 210, and
between openings 210 and 212, respectively. Distance d.sub.4 is a
distance between the distal tip 201 (with opening 208c) and the
opening 212. FIG. 33D is a front view of the distal end of the
catheter, and show distal tip 201 and opening 208c, as well as the
normal vector N of the flat side 214. In addition to the above
features, FIGS. 33A-33D also illustrate the relationship between
the openings 210 and 212 relative to the pre-formed curve of the
catheter in an embodiment. For example, openings 210 and 212 are
each formed on an inner curve of the curved portions of the
pre-formed curve. In addition, FIGS. 33A-33D illustrate the
relationship between the flat side 214 and the direction of the
pre-formed curve according to an embodiment. For example, with the
normal vector of the flat side 214 directed out of the page in FIG.
33A, the pre-formed curve curves the catheter towards the top of
the page (in the horizontal view shown). Thus, the direction of the
curve is orthogonal to the normal vector of the flat side 214.
[0195] FIGS. 34A-34F show various isometric views of the catheter
according to an embodiment. As shown in FIGS. 34A-34F, both the
flat and curved sides 214, 216 can have openings 208a, 208b. As
described above, openings 208a and 208b may open to the first lumen
226 for suction. Additionally, opening 208c, shown in FIGS.
34B-34F, can also open to the first lumen 226. In this embodiment,
openings 210 and 212 are each formed on inner curves of the
pre-formed curve.
[0196] Some embodiments of the present invention may include a
catheter for insertion into a body lumen of a patient. The catheter
may include a distal end configured for insertion into the body
lumen of the patient, a proximal end, and an elongated body. The
elongated body may extend between the proximal and distal ends and
may have a cross-section that includes, over at least a portion of
the elongated body, a first side that is flat. The elongated body
may also include a second side on an opposite side of the
cross-section from the first side. The catheter also may include at
least one lumen extending through the elongated body from the
proximal end to the distal end. The elongated body may include a
pre-formed curve near the distal end. Alternatively, the elongated
body may comprise multiple pre-formed curves, or a compound curve.
When the distal end is inserted into the body lumen of the patient,
the first side of the cross-section may contact a first inner side
of a delivery lumen (e.g., an endotracheal tube) of the catheter
when the catheter is in a first orientation, and the second side of
the cross-section may contact the first inner side of the delivery
lumen of the catheter when the catheter is in a second orientation.
In some embodiments, the second orientation may be a 180.degree.
rotation of the catheter about a longitudinal axis of the elongated
body relative to the first orientation. Embodiments of the present
invention can include or be used with endotracheal tubes of various
diameters, including, for example, diameters of 5 mm to 8 mm.
[0197] According to some embodiments, the curve direction (see the
arrow in FIGS. 26C and 26D) of the pre-formed curve is 90.degree.
with respect to a normal direction N of the flat side of the
cross-section. For example, in FIG. 26D, the normal vector N of the
flat side 214 is in the direction of z-axis (i.e., coming out of
the page) and the curve direction (shown by the arrow) is in the
negative y-direction. Also, for comparison, FIG. 26C shows another
view of a catheter where the curved side 216 is visible. Thus, in
FIG. 26C, the normal vector N of the flat side 214 (not shown)
would be in the negative z-direction (i.e., directed into the
page). The curve direction (indicated by the arrow in FIG. 26C) is
in the negative y-direction. This relationship between the
catheter's surface orientation and the direction of the curve can
achieve a desirable binary response for easily positioning the
distal end of the catheter in either of the left and right
bronchi.
[0198] According to some embodiments, the second side of the
catheter's cross-section is curved. For example, the cross-section
may D-shaped. Alternatively, the second side may be flat.
[0199] The catheter may also include a curve-direction indicator on
the proximal end that indicates a curve direction of the pre-formed
curve of the distal end of the catheter. Thus, an operator of the
catheter may be assured of the direction in which the distal end of
the catheter is disposed. The curve-direction indicator can be a
connector or part of a connector on the proximal end of the
catheter. The connector may include a central connection portion
and a side connection portion extending from the central connection
portion, where the direction in which the side connection portion
extends corresponds to the curve direction of the preformed curve.
For example, a respiration port that extends at an angle from the
longitudinal axis of the catheter may serve as the curve-direction
indicator.
[0200] The curve and the first side of the catheter are arranged
such that, when the distal end is inserted into the body lumen of
the patient, the curve directs the elongated body toward one of a
left bronchus and a right bronchus of the patient in the first
orientation, and toward the other of the left bronchus and the
right bronchus of the patient in the second orientation. The
catheter may have a torsional stiffness such that, when the distal
end is inserted into the body lumen of the patient, the distal end
remains disposed toward one of the left bronchus and the right
bronchus within a range of rotation of the proximal end from
0.degree. to a first predetermined angle. The angle of rotation of
the proximal end is, for example, relative to one of the first and
second orientations. The distal end of the catheter may be disposed
toward the other of the left and right bronchus between the first
predetermined angle and a second predetermined angle of the
proximal end. In some embodiments, the first predetermined angle is
at least 90.degree., and the second predetermined angle is at least
180.degree.. However, the first predetermined angle may be about
180.degree. and the second predetermined angle may be about
360.degree.. Alternatively, the first predetermined angle may be
about 90.degree. and the second predetermined angle may be about
270.degree. in an embodiment. In yet another embodiment, the first
predetermined angle may be about 150.degree. and the second
predetermined angle may be about 210.degree..
[0201] According to another embodiment of the present invention, a
catheter for insertion into a body lumen of a patient is provided
that has a distal end configured for insertion into the body lumen
of the patient, a proximal end, and an elongated body that extends
between the proximal and distal ends. The elongated body may have a
cross-section that includes, over at least a portion of the
elongated body, a portion that is substantially flat. Additionally,
the elongated body may have a torqueability ratio of 1:1 between
the distal and proximal ends of the catheter. Further, the catheter
may include at least one lumen extending through the elongated body
from the proximal end to the distal end. The elongated body may be
inserted through a delivery lumen of an outer catheter when in use.
When the distal end is inserted into the body lumen of the patient,
the distal end may be directed toward one of a left bronchus and a
right bronchus of the patient. The distal end remains directed
toward the one of the left and right bronchi during a rotation of
the proximal end about a longitudinal axis of the elongated body
until a predetermined angle of rotation of the proximal end is
reached, at which point the distal end flips to the other of the
left bronchus and the right bronchus. The predetermined angle may
be at least 90.degree., and may be about 180.degree..
[0202] The catheter may include a pre-formed curve near the distal
end that directs the distal end toward one of the left bronchus and
the right bronchus. The pre-formed curve may be a compound curve.
For example, there may be two curved portions that have different
curvatures. When the distal end of the catheter is inserted into
the body lumen of the patient, the portion that is substantially
flat may contact a first inner side of the delivery lumen when the
catheter is in a first orientation. Additionally, the portion that
is substantially flat may not contact the first inner side of the
delivery lumen when the catheter is in a second orientation. In
some embodiments, the portion that is substantially flat may
contact the second inner side of the delivery lumen when in the
second orientation. The distal end of the catheter may be directed
toward one of the left bronchus and the right bronchus in the first
orientation and toward the other of the left and right bronchi in
the second orientation. The substantially flat portion of the
catheter may contact the first inner side of the delivery lumen at
only one point in the first orientation, and may contact the first
inner side of the delivery lumen at only two points in at least one
of the first and the second orientations.
[0203] The catheter may be include of a copolymer material,
including, for example, a polymer from the Kynar Flex.RTM.
Copolymer Series. In one example of an embodiment, the polymer is
Kynar Flex 2500-20 Medical Grade. However, other alternative
materials or equivalents may also be used, including Kynar RX 752
and Pebax 53/60/70/72D, for example.
[0204] According to another embodiment of the present invention, a
catheter is provided that includes a distal end configured for
insertion into the body lumen of the patient, a proximal end, and
an elongated body extending between the proximal and distal ends.
The elongated body may have a torqueability ratio of 1:1 between
the distal and proximal ends. The catheter may also include at
least one lumen extending through the elongated body from the
proximal end to the distal end. According to this embodiment, the
catheter may have a torsional stiffness such that, when the
elongated body is inserted into a delivery lumen of an outer
catheter, the distal end remains in one of a first resting
orientation and a second resting orientation during a rotation of
the proximal end about a longitudinal axis of the catheter. The
distal end of the catheter may remain in the first resting
orientation through greater than 90.degree. of rotation of the
proximal end of the catheter and may change from the first resting
orientation to the second resting orientation when the proximal end
rotates about 180.degree..
[0205] According to another embodiment of the present invention, a
method of orienting a catheter in a body lumen of a patient is
provided. The method may include providing the catheter that may
include a distal end configured for insertion into the body lumen
of the patient, a proximal end, and an elongated body extending
between the proximal and distal ends. The method may also include
providing an outer catheter adapted to be inserted into a body
lumen of a patient, as well as to receive the distal end of the
catheter. The method may further include inserting the catheter
into the body lumen of the patient through the outer catheter and
rotationally orienting the proximal end of the catheter to a first
orientation. In the first orientation, the distal end of the
catheter may be directed toward one of a left bronchus and a right
bronchus of the patient. Additionally, the method may include
changing a direction of the distal end of the catheter by rotating
the proximal end of the catheter to a second orientation. The
second orientation may be a substantially 180.degree. rotation of
the proximal end relative to the first orientation. The distal end
of the catheter may be directed toward the other of the left and
right bronchi when the proximal end is in the second
orientation.
[0206] According to another embodiment of the present invention a
catheter is provided that may include a distal end configured for
insertion into the body lumen of the patient, a proximal end, and
an elongated body extending between the proximal and distal ends.
The elongated body may have a cross-section that includes, over at
least a portion of the elongated body, a portion that is
substantially flat. The catheter may also include a lumen extending
through the elongated body from the proximal end to the distal end.
The invention is not limited to a single lumen, and embodiments may
include multiple lumens, including two, three or more lumens, for
example. The catheter may also include a pre-formed curve near the
distal end of the elongated body. Some embodiments may have more
than one pre-formed curve, or a compound curve. At least one
pre-formed curve curves the catheter in a direction that is
orthogonal to a normal direction N of the flat side 214 of the
catheter 200 (see FIGS. 26C, 26D, and 26F). The elongated body of
the catheter may have a torqueability ratio of 1:1 between the
distal and proximal ends. The distal end of the catheter can remain
directed toward one of the left bronchus and the right bronchus of
a patient during a rotation of the proximal end about a
longitudinal axis of the elongated body until a predetermined angle
of rotation of the proximal end is reached. When the predetermined
angle of rotation is reached, the distal end of the catheter flips
to the other of the left bronchus and the right bronchus.
[0207] When multiple lumens are provided, there may be a first
lumen with a first opening near the distal end of the catheter, and
a second lumen with a second opening near the distal end of the
catheter. The second opening can be spaced apart from the first
opening such that the first opening is disposed distally to the
second opening. The second opening may be disposed on the inside of
the curve of the at least one pre-formed curve, for example.
[0208] Although the foregoing description includes some embodiments
with two catheters and some embodiments with a single catheter,
features of any one of the above-described embodiments may apply to
embodiments having either one or two catheters.
[0209] The implementations include both open and closed systems. A
closed system may include systems where the secretions and/or
mucous may be contained in the system. A closed system is shown and
described with reference to FIGS. 19-24, for example. An open
system is not closed, and the operator may be exposed to the
secretions and/or mucous. An open system is shown and described
with reference to FIG. 15D, for example. Although in an open system
a secretion bag is typically not used, it is contemplated that a
secretion bag may be used with the open system.
[0210] Although the foregoing description is directed to the
preferred embodiments of the invention, it is noted that other
variations and modifications will be apparent to those skilled in
the art, and may be made without departing from the spirit or scope
of the invention. Moreover, features described in connection with
one embodiment of the invention may be used in conjunction with
other embodiments, even if not explicitly stated above.
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