U.S. patent number RE39,451 [Application Number 10/994,218] was granted by the patent office on 2006-12-26 for double-lumen catheter.
This patent grant is currently assigned to Spire Biomedical, Inc.. Invention is credited to William G. Kuhle.
United States Patent |
RE39,451 |
Kuhle |
December 26, 2006 |
**Please see images for:
( Certificate of Correction ) ** |
Double-lumen catheter
Abstract
A catheter is described. In one embodiment, the catheter
includes: a shaft segment including a shaft segment uptake lumen
and a shaft segment return lumen; and a distal end segment coupled
to the shaft segment, the distal end segment including a distal end
segment uptake lumen and a distal end segment return lumen, where
the distal end segment central axis forms a non-zero angle with the
shaft segment central axis when the catheter is in its unstressed
configuration. In a second embodiment, the catheter includes: a
shaft segment; and a distal end segment coupled to the shaft
segment; where the uptake lumen distal end is terminated by a
closed surface, further where the uptake lumen distal segment
includes only one side hole. In a third embodiment, the catheter
includes: an uptake lumen; and a return lumen; where at least a
portion of the return lumen distal segment is helically coiled
around the uptake lumen distal end.
Inventors: |
Kuhle; William G. (Camas,
WA) |
Assignee: |
Spire Biomedical, Inc.
(Bedford, MA)
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Family
ID: |
26905033 |
Appl.
No.: |
10/994,218 |
Filed: |
November 19, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60210294 |
Jun 8, 2000 |
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Reissue of: |
09877827 |
Jun 8, 2001 |
06482169 |
Nov 19, 2002 |
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Current U.S.
Class: |
604/6.16;
607/105; 604/43; 604/284 |
Current CPC
Class: |
A61M
25/0026 (20130101); A61M 1/3661 (20140204); A61M
25/0023 (20130101); A61M 25/0041 (20130101); A61M
25/007 (20130101); A61M 2025/0031 (20130101); A61M
2025/0037 (20130101) |
Current International
Class: |
A61M
37/00 (20060101); A61F 7/00 (20060101); A61M
25/00 (20060101); A61M 3/00 (20060101) |
Field of
Search: |
;604/4.01,5.01-5.04,6.16,19,27,28,39,43,44,48,500,507-8,264-266,270,271,523-527,530,532,535,538,284,540,541,544
;606/108-109,191,194 ;607/105 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Medcomp, Bio-Flex Tesio--Catalog PN2114 Rev. B 7/01 (Long Term
Hemodialysis Catheters), 4 pp. cited by other .
Description of "Udall Double Lumen Hemodialysis Catheter Tray,"
from Cook Diagnostic and Interventional Products brochure, 3 pp.
cited by other .
Description of "Infuse-a-Cath", Pfizer, Strato Medical
adertisement, 2 pp. cited by other .
PolyCath/Instructions for Use, from Strato Medical Corporation, 12
pp. cited by other .
Picture of device believed to be partial sample of a product
believed to have been sold in the United States with the Polycath
and/or Infuse-a-Cath Instructions for Use, 1 page. cited by other
.
FloLock, Single Lumen Bi-directional Valved Catheter, Instructions
for Use, from Pfizer Strato Medical, 4 pp. cited by other .
Schon.TM. Chronic Dialysis Catheter from AngioDynamics.RTM.
Incorporated, 2 pp. cited by other .
Dialysis Vascular Access, "Technological Innovations Improving
Flow," 2 pp. cited by other .
SchonCath.RTM. Long Term Dialysis, "Single Insertion Efficiency . .
. Dual Catheter Effectiveness," AngioDynamics.RTM. Incorporated, 2
pp. cited by other.
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Primary Examiner: Bianco; Patricia
Attorney, Agent or Firm: Nutter, McClennen & Fish LLP
Engellenner; Thomas J.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Application
Ser. No. 60/210,294, filed Jun. 8, 2000, and entitled "Double-Lumen
Catheters Used for Hemodialysis".
Claims
What is claimed is:
1. A .Iadd.hemodialysis .Iaddend.catheter comprising: a shaft
segment, said shaft segment including a proximal end of the
catheter and a shaft segment central axis, wherein said shaft
segment comprises a shaft segment uptake lumen and a shaft segment
return lumen; a distal end segment coupled to the shaft segment,
said distal end segment including a distal end of the catheter and
a distal end segment central axis, wherein said distal end segment
comprises a distal end segment uptake lumen and a distal end
segment return lumen, further wherein said distal end segment
uptake and return lumens are coupled to said shaft segment uptake
and return lumens, respectively; wherein .Iadd.said distal end
segment uptake lumen comprises a distal end segment uptake lumen
central axis, said distal end segment return lumen comprises a
distal end segment return lumen central axis, and.Iaddend. said
distal end segment central axis .Iadd.is parallel to said distal
end segment uptake lumen central axis and .Iaddend.forms a non-zero
angle with the shaft segment central axis when said catheter is in
its unstressed configuration .Iadd.whereby said uptake lumen can be
directed away from an adjacent wall when the catheter is inserted
into a patient.Iaddend..
2. The catheter of claim 1, wherein the non-zero angle is in the
range of 5 to 60 degrees.
3. The catheter of claim 1, wherein the non-zero angle is in the
range of 5 to 45 degrees.
4. The catheter of claim 1, wherein the non-zero angle is in the
range of 5 to 30 degrees.
.[.5. The catheter of claim 1, wherein said distal end segment
uptake lumen and distal end segment return lumen comprise a distal
end segment uptake lumen central axis and distal end segment return
lumen central axis, respectively..].
6. The catheter of .[.claim 5.]. .Iadd.claim 1.Iaddend., wherein
the distal end segment uptake lumen central axis and distal end
segment return lumen central axis are .Iadd.both .Iaddend.parallel
to the distal end segment central axis.
7. The catheter of .[.claim 5.]. .Iadd.claim 1.Iaddend., wherein
the distal end segment uptake lumen central axis is parallel to the
distal end segment central axis .Iadd.and forms a non-zero angle
with the shaft segment central axis.Iaddend., .Iadd.and
.Iaddend.further wherein the distal end segment return lumen
central axis is parallel to the shaft segment central axis.
8. The catheter of .[.claim 5.]. .Iadd.claim 1.Iaddend., wherein
the distal end segment uptake lumen central axis is parallel to the
distal end segment central axis .Iadd.and forms a non-zero angle
with the shaft segment central axis.Iaddend., .Iadd.and
.Iaddend.further wherein the distal end segment return lumen
central axis forms a second non-zero angle with the shaft segment
central axis.
9. The catheter of claim 1, wherein said distal end segment uptake
lumen comprises an uptake hole and said distal end segment return
lumen comprises a return hole.
10. The catheter of claim 9, wherein said uptake hole is located
proximally with respect to the return hole.
11. The catheter of claim 9, wherein said uptake hole is directed
away from a lateral wall of a vessel when the catheter is in the
vessel.
12. The catheter of claim 9, wherein said shaft segment comprises a
lateral side wall, further wherein said uptake hole is directed
away from the lateral side wall such that a separation is
maintained between a lateral wall of a vessel and said uptake hole
when the catheter is in the vessel and the lateral side wall abuts
the lateral wall of the vessel.
13. The catheter of claim 9, wherein said distal end segment return
lumen comprises a return lumen end segment, further wherein said
return lumen end segment maintains a separation between a medial
wall of a vessel and said uptake hole when the catheter is in the
vessel.
14. The catheter of claim 9, wherein said distal end segment return
lumen comprises a return lumen end segment, further wherein said
return lumen end segment shields the uptake hole from a medial wall
of a vessel when the catheter is in the vessel.
15. The catheter of claim 11, wherein said uptake hole is medially
oriented with respect to the lateral wall of the vessel.
16. The catheter of claim 1, wherein the catheter is comprised of a
flexible plastic material.
17. A catheter comprising: a shaft segment, said shaft segment
including a proximal end of the catheter and a shaft segment
central axis; a distal end segment coupled to the shaft segment,
said distal end segment including a distal end of the catheter and
a distal end segment central axis; wherein said distal end segment
central axis is parallel to the shaft segment central axis when
said catheter is in its unstressed configuration, further wherein
said distal end segment comprises a return lumen and an uptake
lumen having a return lumen distal end and an uptake lumen distal
end, respectively, further wherein the uptake lumen distal end is
terminated by a closed surface, further wherein the uptake lumen
distal segment includes only one side hole .Iadd.whereby leakage of
anticoagulant solution can be minimized.Iaddend..
18. The catheter of claim 17, wherein said shaft segment comprises
a shaft segment uptake lumen and a shaft segment return lumen,
further wherein said shaft segment uptake and return lumens are
coupled to the distal end segment uptake and return lumens,
respectively.
19. The catheter of claim 17, wherein said distal end segment
return lumen comprises a return hole, further wherein said only one
side hole is located proximally with respect to the return
hole.
20. The catheter of claim 17, wherein said one side hole is
directed away from a lateral wall of a vessel when the catheter is
in the vessel.
21. The catheter of claim 20, wherein said one side hole is
medially oriented with respect to the lateral wall of the
vessel.
22. The catheter of claim 17, wherein the catheter is comprised of
a flexible plastic material.
23. A catheter comprising: an uptake lumen including an uptake
lumen shaft segment and an uptake lumen distal segment with an
uptake lumen distal end; a return lumen including a return lumen
shaft segment and a return lumen distal segment with a return lumen
distal end; wherein the uptake lumen shaft segment is substantially
parallel to the return lumen shaft segment, further wherein at
least a portion of the return lumen distal segment is helically
coiled around the uptake lumen distal end.
24. The catheter of claim 23, wherein said uptake lumen distal end
segment comprises an uptake hole and said return lumen distal end
segment comprises a return hole, further wherein said return hole
is located distally with respect to the uptake hole.
25. The catheter of claim 23, wherein the return lumen end segment
comprises a portion parallel to the uptake lumen end segment and
disposed more distally than the uptake lumen distal end.
26. The catheter of claim 23, wherein said uptake lumen distal
segment includes an uptake lumen end hole at the uptake lumen
distal end, further wherein said portion of the return lumen distal
segment helically coils 360 degrees about the uptake lumen end
hole.
27. The catheter of claim 26, wherein said portion of the return
lumen distal segment shields the uptake lumen end hole from a blood
vessel or atrium wall when said catheter is disposed in a blood
vessel or atrium.
28. The catheter of claim 23, wherein the catheter is comprised of
a flexible plastic material.
.Iadd.29. A hemodialysis catheter comprising: a shaft segment, said
shaft segment including a proximal end of the catheter and a shaft
segment central axis, wherein said shaft segment comprises a shaft
segment uptake lumen and a shaft segment return lumen; a distal end
segment coupled to the shaft segment, said distal end segment
including a distal end of the catheter, wherein said distal end
segment comprises a distal end segment uptake lumen and a distal
end segment return lumen, further wherein said distal end segment
uptake and return lumens are coupled to said shaft segment uptake
and return lumens and comprise a distal end segment uptake lumen
central axis and distal end segment return lumen central axis,
respectively; wherein said distal end segment uptake lumen central
axis forms a non-zero angle with the shaft segment central axis
when said catheter is in its unstressed configuration whereby said
uptake lumen can be directed away from an adjacent wall when the
catheter is inserted into a patient..Iaddend.
.Iadd.30. The catheter of claim 29, wherein the non-zero angle is
in the range of 5 to 60 degrees..Iaddend.
.Iadd.31. The catheter of claim 29, wherein the non-zero angle is
in the range of 5 to 45 degrees..Iaddend.
.Iadd.32. The catheter of claim 29, wherein the non-zero angle is
in the range of 5 to 30 degrees..Iaddend.
.Iadd.33. The catheter of claim 29, wherein the distal end segment
uptake lumen central axis and distal end segment return lumen
central axis are parallel to each other..Iaddend.
.Iadd.34. The catheter of claim 29, wherein the distal end segment
return lumen central axis is parallel to the shaft segment central
axis..Iaddend.
.Iadd.35. The catheter of claim 29, wherein the distal end segment
return lumen central axis forms a second non-zero angle with the
shaft segment central axis..Iaddend.
.Iadd.36. The catheter of claim 29, wherein said distal end segment
uptake lumen comprises at least one uptake hole and said distal end
segment return lumen comprises at least one return
hole..Iaddend.
.Iadd.37. The catheter of claim 36, wherein said uptake hole is
located proximally with respect to the return hole..Iaddend.
.Iadd.38. The catheter of claim 36, wherein said uptake hole is
directed away from a lateral wall of a vessel when the catheter is
in the vessel..Iaddend.
.Iadd.39. The catheter of claim 36, wherein said shaft segment
comprises a lateral side wall, further wherein said uptake hole is
directed away from the lateral side wall such that a separation is
maintained between a lateral wall of a vessel and said uptake hole
when the catheter is in the vessel and the lateral side wall abuts
the lateral wall of the vessel..Iaddend.
.Iadd.40. The catheter of claim 36, wherein said distal end segment
return lumen comprises a return lumen end segment, further wherein
said return lumen end segment maintains a separation between a
medial wall of a vessel and said uptake hole when the catheter is
in the vessel..Iaddend.
.Iadd.41. The catheter of claim 36, wherein said distal end segment
return lumen comprises a return lumen end segment, further wherein
said return lumen end segment shields the uptake hole from a medial
wall of a vessel when the catheter is in the vessel..Iaddend.
.Iadd.42. The catheter of claim 38, wherein said uptake hole is
medially oriented with respect to the lateral wall of the
vessel..Iaddend.
.Iadd.43. The catheter of claim 29, wherein the catheter is
comprised of a flexible plastic material..Iaddend.
.Iadd.44. A hemodialysis catheter comprising: a shaft segment, said
shaft segment including a proximal end of the catheter and a shaft
segment central axis, wherein said shaft segment comprises a shaft
segment uptake lumen and a shaft segment return lumen; a distal end
segment coupled to the shaft segment, said distal end segment
including a distal end of the catheter, wherein said distal end
segment comprises a distal end segment uptake lumen and a distal
end segment return lumen, further wherein said distal end segment
uptake and return lumens are coupled to said shaft segment uptake
and return lumens and comprise a distal end segment uptake lumen
central axis and distal end segment return lumen central axis,
respectively; wherein said distal end segment uptake lumen central
axis forms a non-zero angle with the shaft segment central axis
when said catheter is in its unstressed configuration, wherein the
non-zero angle is in the range of 5 to 60 degrees..Iaddend.
.Iadd.45. The catheter of claim 44, wherein the distal end segment
uptake lumen central axis is angled with respect to the shaft
segment central axis so that said uptake lumen can be directed away
from an adjacent wall when the catheter is inserted into a
patient..Iaddend.
.Iadd.46. The catheter of claim 44, wherein the non-zero angle is
in the range of 5 to 45 degrees..Iaddend.
.Iadd.47. The catheter of claim 44, wherein the non-zero angle is
in the range of 5 to 30 degrees..Iaddend.
.Iadd.48. The catheter of claim 44, wherein the distal end segment
uptake lumen central axis and distal end segment return lumen
central axis are parallel to each other..Iaddend.
.Iadd.49. The catheter of claim 44, wherein the distal end segment
return lumen central axis is parallel to the shaft segment central
axis..Iaddend.
.Iadd.50. The catheter of claim 44, wherein the distal end segment
return lumen central axis forms a second non-zero angle with the
shaft segment central axis..Iaddend.
.Iadd.51. The catheter of claim 44, wherein said distal end segment
uptake lumen comprises at least one uptake hole and said distal end
segment return lumen comprises at least one return
hole..Iaddend.
.Iadd.52. The catheter of claim 51, wherein said uptake hole is
located proximally with respect to the return hole..Iaddend.
.Iadd.53. The catheter of claim 51, wherein said uptake hole is
directed away from a lateral wall of a vessel when the catheter is
in the vessel..Iaddend.
.Iadd.54. The catheter of claim 51, wherein said shaft segment
comprises a lateral side wall, further wherein said uptake hole is
directed away from the lateral side wall such that a separation is
maintained between a lateral wall of a vessel and said uptake hole
when the catheter is in the vessel and the lateral side wall abuts
the lateral wall of the vessel..Iaddend.
.Iadd.55. The catheter of claim 51, wherein said distal end segment
return lumen comprises a return lumen end segment further wherein
said return lumen end segment maintains a separation between a
medial wall of a vessel and said uptake hole when the catheter is
in the vessel..Iaddend.
.Iadd.56. The catheter of claim 51, wherein said distal end segment
return lumen comprises a return lumen end segment further wherein
said return lumen end segment shields the uptake hole from a medial
wall of a vessel when the catheter is in the vessel..Iaddend.
.Iadd.57. The catheter of claim 53, wherein said uptake hole is
medially oriented with respect to the lateral wall of the
vessel..Iaddend.
.Iadd.58. The catheter of claim 44, wherein the catheter is
comprised of a flexible plastic material..Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates generally to catheters and, in
particular, though not exclusively, to double-lumen catheters used
for hemodialysis.
BACKGROUND OF THE INVENTION
Hemodialysis catheters are conventionally large double-lumen
catheters. Generally, the lumens must be large enough to support
flow rates greater than 250 c c/min through each lumen. A
hemodialysis catheter resides within a large vein within the body
or within the right atrium of the heart. The end of the catheter
placed into a patient's body is referred to as the distal end of
the catheter, while the end connected to a dialysis machine is
called the proximal end. Blood is withdrawn out of a vein via an
uptake lumen of the catheter and into the dialysis machine. The
uptake lumen is also referred to herein as the withdrawal lumen.
The dialyzed blood is returned to the body via the return lumen.
The uptake lumen has an uptake lumen hole (also referred to as an
uptake lumen opening) for withdrawal of blood from the body. The
uptake lumen hole is typically disposed at the distal end of the
uptake lumen. Similarly, the return lumen has a return lumen hole
for return of blood to the body. The return lumen hole is typically
disposed at the distal end of the return lumen. The uptake and
return lumen holes are generally spatially separated from each
other, typically with the uptake lumen hole located proximal to the
return lumen. This is usually accomplished by making the uptake
lumen shorter than the return lumen. The above configuration of the
uptake and return lumen holes minimizes the immediate redialysis of
blood just returned to the body.
FIG. 1 is a side view of a first embodiment of double lumen
catheters in the prior art. In FIG. 1, catheter 100 includes a
proximal end 110, a distal end 120, and a central axis 130. The
central axis may also herein be referred to as the longitudinal
axis. Catheter 100 also includes an uptake lumen end hole 141 and a
return lumen end hole 142. As can be seen in FIG. 1, uptake lumen
end hole 141 is located proximally with respect to return lumen end
hole 142.
On occasion, prior art catheters, such as that shown in FIG. 1,
fail to perform their intended function. The failure modes of these
catheters are numerous. One common type of failure is occlusion of
the uptake lumen end hole by the adjacent wall of the vein or by
the wall of the right atrium. That is, when blood is withdrawn at a
rapid rate from the vein via the uptake lumen, the uptake lumen end
hole has a propensity to aspirate (or "suck up") against any
adjacent structure. This adverse action of the uptake lumen end
hole either limits the flow rate of the catheter or occludes blood
flow entirely through the catheter.
Some of the available hemodialysis catheters address this problem
by designing the uptake lumen to have several side holes. FIG. 2 is
a side view of a prior art catheter having such side holes.
Catheter 200, in FIG. 2, has a proximal end 210, a distal end 220,
and a central axis 230. Catheter 200 also includes uptake lumen
side holes 241 in the uptake lumen and return lumen side holes 242
in the return lumen. With this configuration, even if one side hole
of the uptake lumen is sucked or aspirated against an adjacent
wall, the catheter functions because the other side holes of the
uptake lumen are not aspirated against the wall.
However, this design, in which multiple side holes are present to
prevent occlusion by adjacent walls, presents a drawback of its
own. When any hemodialysis catheter is not in use, both lumens are
filled (or "locked") with an anticoagulant solution, typically
concentrated heparin sulfate. This solution is intended to prevent
blood clots from forming on or within the catheter's lumens. Such
blood clots would occlude the lumens, leading to catheter failure.
If the uptake lumen has multiple side holes, the anticoagulant
solution leaks away at the catheter tip through these multiple side
holes, causing an increased risk of blood clot formation on the
catheter's tip, thus causing subsequent catheter failure.
A hemodialysis catheter whose uptake lumen consists of a single end
hole will retain the anticoagulant solution. However, as detailed
above, such a prior-art hemodialysis catheter retains a tendency to
have its uptake lumen end hole aspirate against an adjacent wall
and occlude the uptake lumen.
The intravenous portion of conventional hemodialysis catheters are
linear in configuration. The lumens of such catheters run parallel
to each other within a single, flexible silicon housing, with the
lumens separated by a silicone septum. FIGS. 3a, 3b, and 3c are a
first, second, and third embodiments, respectively, of the cross
sectional view along each of lines 3--3 in FIGS. 1 and 2. The views
in FIGS. 3a, 3b, and 3c represent different embodiments for
partitioning the uptake and return lumens. In FIGS. 3a, 3b, and 3c,
cross sections 301 and 302 represent cross sections of the uptake
lumen and return lumen, respectively, in the three different
embodiments of the cross sections of the catheter. FIGS. 3a, 3b,
and 3c also represent three different embodiments of the view along
the central axis from the distal end to the proximal end (as well
as the view along the central axis from the proximal end to the
distal end) in the catheters of FIGS. 1 and 2.
Discussion of prior art catheters, such as those described above,
can be found in U.S. Pat. No. 5,209,723, U.S. Pat. No. 5,947,953,
and U.S. Pat. No. 6,001,079, which are incorporated by reference
herein.
Accordingly, there is a need for a catheter that addresses the
above disadvantages of prior art catheters.
SUMMARY OF THE INVENTION
The present invention encompasses a catheter. In one embodiment,
the catheter includes: a shaft segment, the shaft segment including
a proximal end of the catheter and a shaft segment central axis,
the shaft segment further including a shaft S segment uptake lumen
and a shaft segment return lumen; a distal end segment coupled to
the shaft segment, the distal end segment including a distal end of
the catheter and a distal end segment central axis, the distal end
segment further including a distal end segment uptake lumen and a
distal end segment return lumen, where the distal end segment
uptake and return lumens are coupled to the shaft segment uptake
and return lumens, respectively; where the distal end segment
central axis forms a non-zero angle with the shaft segment central
axis when the catheter is in its unstressed configuration.
In a second embodiment, the catheter includes: a shaft segment, the
shaft segment including a proximal end of the catheter and a shaft
segment central axis; a distal end segment coupled to the shaft
segment, the distal end segment including a distal end of the
catheter and a distal end segment central axis; where the distal
end segment central axis is parallel to the shaft segment central
axis when the catheter is in its unstressed configuration, further
where the distal end segment includes a return lumen and an uptake
lumen having a return lumen distal end and an uptake lumen distal
end, respectively, further where the uptake lumen distal end is
terminated by a closed surface, further where the uptake lumen
distal segment includes only one side hole.
In a third embodiment, the catheter includes: an uptake lumen
including an uptake lumen shaft segment and an uptake lumen distal
segment with an uptake lumen distal end; a return lumen including a
return lumen shaft segment and a return lumen distal segment with a
return lumen distal end; where the uptake lumen shaft segment is
substantially parallel to the return lumen shaft segment, further
where at least a portion of the return lumen distal segment is
helically coiled around the uptake lumen distal end.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a first embodiment of double-lumen
catheter in the prior art.
FIG. 2 is a side view of a second embodiment of double-lumen
catheter in the prior art.
FIGS. 3a, 3b, and 3c are three different embodiments of the cross
sectional view along each of lines 3--3 in FIGS. 1, 2, 4, 5, and
6.
FIG. 4 is a side view of a first embodiment of the catheter of the
present invention.
FIG. 5 is a side view of a second embodiment of the catheter of the
present invention.
FIG. 6 is a side view of a third embodiment of the catheter of the
present invention.
FIG. 7 is a side view of a fourth embodiment of the catheter of the
present invention.
FIG. 8 is a bottom view from the distal end to the proximal end of
the catheter in FIG. 7.
FIG. 9 is a side view of a fifth embodiment of the catheter of the
present invention.
FIGS. 10a, 10b, and 10c are three embodiments of the cross
sectional view along each of lines 10--10 in FIG. 9.
DETAILED DESCRIPTION
FIG. 4 is a side view of a first embodiment of the catheter of the
present invention. Catheter 400, in FIG. 4, has a proximal end 410,
a distal end 420, and a central axis 430. Catheter 400 includes a
shaft segment 490 (which may also herein be referred to as the
intravenous portion) and a distal end segment 450. In one
embodiment, distal end segment is 450 is much smaller than the
shaft segment 490. (Please note that figures in this application
are not drawn to size.) Central axis 430 is a straight line that
runs along the length of the catheter 400, including the shaft
segment 490 and distal end segment 450.
Catheter 400 includes an uptake lumen side hole 441 and a return
lumen end hole 442 in the distal end segment 450. In catheter 400,
uptake lumen side hole 441 is the only uptake lumen hole. Catheter
400 does not have any other uptake lumen side holes in addition to
uptake lumen side hole 441. Additionally, catheter 400 does not
include an uptake lumen end hole since the distal end of uptake
lumen 440 is sealed i.e., the uptake lumen distal end is terminated
by a closed surface. In other words, unlike catheter 100 (in FIG.
1), catheter 400 does not include an uptake lumen end hole.
Catheter 400 can be inserted by a physician into a vein or the
atrium of a patient such that the uptake lumen side hole 441 is
oriented in a direction opposite that of the nearest wall to help
prevent adherence of the lumen to a vein or atrium wall. Thus,
uptake lumen side hole 441 is a directable uptake lumen hole, i.e.,
it can be directed away from a vessel or atrium wall. This
addresses the problem associated with prior art catheters, such as
that shown in FIG. 1, which do not include a directable uptake
lumen hole.
In one embodiment, the uptake lumen side hole 441 is directed away
from a lateral wall of a vessel when the catheter is in the vessel.
In one embodiment, the uptake lumen side hole 441 is medially
oriented with respect to the lateral wall of the vessel.
Furthermore, since catheter 400 has only one uptake lumen hole,
where the only uptake lumen hole is an uptake lumen side hole, it
also addresses the problems associated with prior art catheters,
such as that shown in FIG. 2, which include a plurality of uptake
lumen side holes. As noted above, these prior art catheters allow
leakage of anticoagulant solutions which may result in catheter
failures.
Accordingly, catheter 400 of the present invention addresses the
disadvantages of the catheters 100 and 200 of the prior art. In
other words, catheter 400 minimizes obstruction of uptake lumen
caused by either adherence of the catheter to the side walls of a
vein or atrium or by a rapid diffusion of anticoagulant solutions
from the catheter when the catheter is not in use.
FIG. 5 is a side view of a second embodiment of the catheter of the
present invention. Catheter 500 has a proximal end 510, a distal
end 520, and a central axis 530. Catheter 500 includes a shaft
segment 590 and a distal end segment 550. Central axis 530 runs
along the length of shaft segment 590. Distal end segment 550
includes central axis 560 which forms a non-zero angle Y with
central axis 530. Thus, the distal end segment 550 is angled away
from the central axis 530 of the catheter.
Angled distal end segment 550 includes both a portion of the uptake
lumen and a portion of the return lumen. Three embodiments of the
cross sectional view along line 3--3 in the distal end segment 550
are shown in FIGS. 3a, 3b, and 3c.
Angled distal end segment 550 includes a return lumen end hole 542
and an uptake lumen end hole 541 that is located proximally with
respect to the return lumen end hole 542. Angled distal end segment
550 allows the uptake lumen end hole 541 of the uptake lumen of the
catheter 500 to be directed away from the nearest vessel or atrium
wall when the catheter is inserted into a patient. This helps
prevent occlusion of the uptake lumen by the adjacent wall of the
vein or right atrium. Furthermore, since catheter 500 includes only
one uptake lumen hole it minimizes diffusion of anticoagulant
solution from the catheter 500 when the catheter 500 is not in
use.
In one embodiment, the uptake lumen end hole 541 is directed away
from a lateral wall of a vessel when the catheter is in the vessel.
In one embodiment, the uptake lumen end hole 541 is medially
oriented with respect to the lateral wall of the vessel.
FIG. 6 is a side view of a third embodiment of the catheter of the
present invention. In FIG. 6, catheter 600 has a proximal end 610,
a distal end 620, and a central axis 630. Catheter 600 includes a
shaft segment 690 and a distal end segment 650. Central axis 630
runs along the length of shaft segment 690.
Distal end segment 650 includes an uptake lumen end segment 651 and
a return lumen end segment 652. Uptake lumen end segment 651 and
return lumen end segment 652 each comprise separate tubes. Uptake
lumen end segment 651 has a central axis 661 that forms a non-zero
angle Z with central axis 630. Thus, uptake lumen end segment 651
is angled with respect to the central axis 630. On the other hand,
return lumen end segment 652 has a central axis 662 that is
parallel to the central axis 630. Thus, return lumen end segment
652 is not angled with respect to the central axis 630. However,
there is a non-zero angle Z between central axis 662 of the return
lumen end segment 652 and central axis 661 of the uptake lumen end
segment 651. Thus, .Iadd.the distal end segment central axis 655 is
parallel to the central axis 661 of the uptake lumen end segment
651, and .Iaddend.the return lumen end segment 652 is angled at an
angle Z with respect to the uptake lumen end segment 651.
In catheter 600, the angle between central axis 661 and central
axis 630 is the same as the angle between central axis 661 and
central axis 662. In another embodiment, these angles may be
different from each other. This may happen, for example, when there
is a first non-zero angle A1 between central axis 662 and central
axis 630 and a second non-zero angle A2 between central axis 661
and central axis 630, where A1 is not equal to A2.
Uptake lumen (and more specifically the uptake lumen end segment
651) includes an uptake lumen end hole 641. Similarly, return lumen
(and more specifically the return lumen end segment 652) includes a
return lumen end hole 642.
The angled uptake lumen end hole 641 can be directed away from the
nearest vessel or atrium wall when the catheter is inserted into a
patient. This reduces occlusion of the uptake lumen end hole 641 by
the adjacent wall of the vein or right atrium as in the embodiment
shown in FIG. 5. Furthermore, since catheter 600 includes only one
uptake lumen hole it minimizes leakage of anticoagulant solution
from the catheter 600 when the catheter 600 is not in use.
In one embodiment, the uptake lumen end hole 641 is directed away
from a lateral wall of a vessel when the catheter is in the vessel.
In one embodiment, the uptake lumen end hole 641 is medially
oriented with respect to the lateral wall of the vessel.
FIGS. 3a, 3b, and 3c are three embodiments of the cross sectional
view along each of lines 3--3 in FIGS. 4, 5, and 6. The views in
FIGS. 3a, 3b, and 3c represent different embodiments for
partitioning the uptake and return lumens in FIGS. 4, 5, and 6.
FIGS. 3a, 3b, and 3c also represent a bottom view from distal end
420 to the proximal end 410 along central axis 430. It is to be
noted that in the case of such a bottom view, area 301 in FIGS. 3a,
3b, and 3c would represent the sealed end of the uptake lumen of
catheter 400. FIGS. 3a, 3b, and 3c also represent a bottom view
from distal end 520 to line 3--3 in distal end segment 550 along
central axis 560 in FIG. 5.
Referring to FIG. 6, as noted above, uptake lumen end segment 651
and return lumen end segment 652 are each separate tubes. Thus, the
bottom views from uptake lumen end hole 641 and return lumen end
hole 642 along central axis 661 and central axis 662, respectively,
would simply show the outline of the uptake lumen end hole 641 and
the return lumen end hole 642, respectively. The outline can be a
circle, an ellipse or any other configuration that may be used for
a catheter lumen tube.
FIG. 7 is a side view of a fourth embodiment of the catheter of the
present invention. Catheter 700, in FIG. 7, has a proximal end 710,
a distal end 720, and a central axis 730. Catheter 700 includes an
uptake lumen 701 and a return lumen 702. Catheter 700 includes a
shaft segment 790 and a distal end segment 750. (As noted above,
the drawings are not drawn to size. For example, even though the
distal end segment 750 is shown as being longer than the shaft
segment 790, in an actual embodiment, the distal end segment 750 is
in fact much shorter than shaft segment 790.) Shaft segment 790
includes part of the uptake lumen 701 and part of the return lumen
702 disposed in a parallel position to the uptake lumen 701.
Similarly, distal end segment 750 includes part of the uptake lumen
701 and part of the return lumen 702. In the distal end segment
750, the return lumen 702 is helically coiled around the uptake
lumen 701. More specifically, the return lumen 702 is helically
coiled around the uptake lumen distal end 711 and uptake lumen end
hole 741. In one embodiment, the return lumen 702 helically coils
360 degrees about the uptake lumen 701 and the uptake lumen end
hole 741, thus reducing occlusion of the uptake lumen end hole 741
by the adjacent wall of the vein or right atrium. Moreover, the
portion of return lumen 702 helically coiled around the uptake
lumen 701 serves a "bumper" which prevents inadvertent contact
between the uptake lumen end hole 741 and a vessel or atrium wall.
Thus, it shields the uptake lumen end hole 741 from the vessel or
atrium wall.
The distal end of the return lumen 702 corresponds to the distal
end 720 of catheter 700. At the distal end 720, the return lumen
702 includes a return lumen end hole 742. As can be seen in FIG. 7,
the return lumen end hole 742 is disposed distally in relation to
the uptake lumen end hole 741.
FIG. 8 shows a bottom view from the distal end 720 to the proximal
end 710 along central axis 730. It shows uptake lumen end hole 741
and return lumen end hole 742. Additionally it shows return lumen
702 helically coiled around uptake lumen end hole 741.
In FIGS. 7 and 8, dashed lines (with the exception of central axis
730 which is intended to show an imaginary line in the catheter)
represent contours of the catheter 700 that are hidden from view in
the views represented by FIGS. 7 and 8. In FIG. 7, the view at the
uptake lumen distal end 711 and the distal end 720 is slightly
oblique so as to provide a view of end holes 741 and 742.
FIG. 9 is a side view of a fifth embodiment of the catheter of the
present invention. Catheter 900 has a proximal end 910, a distal
end 920, and a central axis 930. Catheter 900 includes a shaft
segment 990 and a distal end segment 950. Central axis 930 runs
along the length of shaft segment 990. Distal end segment 950
includes central axis 960 which forms a non-zero angle Y with
central axis 930. Thus, the distal end segment 950 is angled away
from the central axis 930 of the catheter.
Angled distal end segment 950 includes both a portion of the uptake
lumen and a portion of the return lumen. Three embodiments of the
cross sectional view along line 10--10 in the distal end segment
950 are shown in FIGS. 10a, 10b, and 10c, which are described in
more detail below. Angled distal end segment 950 includes a return
lumen end hole 942 and an uptake lumen end hole 941 that is located
proximally with respect to the return lumen end hole 942. Angled
distal end segment 950 allows the uptake lumen end hole 941 of the
uptake lumen of the catheter 900 to be directed away from the
nearest vessel or atrium wall when the catheter is inserted into a
patient. This reduces occlusion of the uptake lumen by the adjacent
wall of the vein or right atrium. Furthermore, since catheter 900
includes only one uptake lumen hole it minimizes leakage of
anticoagulant solution from the catheter 900 when the catheter 900
is not in use.
An additional factor that helps reduce occlusion of the uptake
lumen in catheter 900 is the relative position of the uptake lumen,
more specifically uptake lumen end hole 941, within catheter 900.
As can be seen in FIG. 9, uptake lumen end hole 941 is located
between the lateral side wall 991 of the shaft 990 and the medial
tip 921 of the distal end 920. In this configuration, uptake lumen
end hole 941 is directed away from the lateral wall of a vessel due
to the fact that the distal end segment 950 is angled away from the
lateral wall. In one embodiment, the uptake lumen end hole 941 is
medially oriented with respect to the lateral wall of the vessel.
The lateral side wall 991 of the shaft would help maintain a
separation between the lateral wall of the vessel and the uptake
lumen end hole 941. Similarly, return lumen end segment 952 of
distal end segment 950 would help maintain a separation between the
medial wall of the vessel and the uptake lumen end hole 941.
Additionally, the return lumen end segment 952 shields the uptake
lumen end hole 941 from the medial wall of the vessel.
FIGS. 10a, 10b, and 10c are three embodiments of the cross
sectional view along each of lines 10--10 in FIG. 9. FIGS. 10a,
10b, and 10c also represent a bottom view from the bottom of the
shaft segment 990 to the proximal end 910 along central axis 930.
FIGS. 10a, 10b, and 10c also represent a bottom view from distal
end 920 to line 10--10 in the distal end segment 950 along central
axis 960. The views in FIGS. 10a, 10b, and 10c represent different
embodiments for partitioning the uptake and return lumens in FIG.
9. In FIGS. 10a, 10b, and 10c, area 1001 represents a cross section
of the uptake lumen in catheter 900 while areas 1002 represents a
cross section of the return lumen in catheter 900.
Double lumen catheters such as 400, 500, 600, 700, and 900 can be
made of flexible plastic material such as silicone, but need not be
made of silicone. Catheters 400, 500, 600, 700 and 900 in FIGS. 4-9
are shown in their unstressed configurations, i.e., their rest
positions, but can be stretched or deformed into relatively linear
configurations for the purpose of introduction into the body. Thus,
in the rest position, each of catheters 500, 600, and 900 includes
a distal end segment that is angled with respect to the central
axis of the catheter shaft segment. Similarly, in the rest
position, catheter 700 has a helically coiled segment surrounding
the uptake lumen end hole.
In the above embodiments, the angle Y may, for example, be in the
range of 5 to 60 degrees, 5 to 45 degrees, or 5 to 30 degrees.
Similarly, the angle Z may, for example, be in the range of 5 to 60
degrees, 5 to 45 degrees, or 5 to 30 degrees. As noted above,
catheters 400, 500, 600, 700 and 900 in FIGS. 4-9 are shown in
their rest positions. Accordingly, the above ranges are examples of
ranges for angles Y and Z when the catheters are in their rest
positions.
In the above description one lumen in each of the drawings has been
referred to as an uptake lumen while the other lumen has been
referred to as the return lumen. It is to be noted that the present
invention may encompass embodiments in which the designation of
uptake lumen and return lumen are the reverse of those in the above
description.
While the present invention has been particularly described with
respect to the illustrated embodiments, it will be appreciated that
various alterations, modifications and adaptations may be made
based on the present disclosure, and are intended to be within the
scope of the present invention. While the invention has been
described in connection with what are presently considered to be
the most practical and preferred embodiments, it is to be
understood that the present invention is not limited to the
disclosed embodiment but, on the contrary, is intended to cover
various modifications and equivalent arrangements included within
the scope of the appended claims.
* * * * *