U.S. patent application number 11/056091 was filed with the patent office on 2005-06-30 for blood treatment catheter and method.
This patent application is currently assigned to AngioDynamics, Inc.. Invention is credited to Appling, William M., Beyer, Theodore J., Geer, Donald R., Rosenblatt, Melvin.
Application Number | 20050143687 11/056091 |
Document ID | / |
Family ID | 28673947 |
Filed Date | 2005-06-30 |
United States Patent
Application |
20050143687 |
Kind Code |
A1 |
Rosenblatt, Melvin ; et
al. |
June 30, 2005 |
Blood treatment catheter and method
Abstract
A blood infusion and aspiration catheter has an annular lumen
surrounding a central lumen. The annular lumen, whether used for
infusion or aspiration, has a set of ports which are aligned along
a circular circumference so that they intersect a common plane.
That common plane is substantially perpendicular to the axis of the
annular lumen. This structural arrangement avoids the compromise of
heparin lock that occurs when the exit or entrance ports at the
distal end of the annular lumen are circumferentially staggered.
These ports in the annular lumen face radially outward to assure
that port edges do not snag on tissue when the catheter is
inserted.
Inventors: |
Rosenblatt, Melvin; (New
Rochelle, NY) ; Appling, William M.; (Granville,
NY) ; Geer, Donald R.; (Queensbury, NY) ;
Beyer, Theodore J.; (Queensbury, NY) |
Correspondence
Address: |
REED SMITH, LLP
ATTN: PATENT RECORDS DEPARTMENT
599 LEXINGTON AVENUE, 29TH FLOOR
NEW YORK
NY
10022-7650
US
|
Assignee: |
AngioDynamics, Inc.
|
Family ID: |
28673947 |
Appl. No.: |
11/056091 |
Filed: |
February 10, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11056091 |
Feb 10, 2005 |
|
|
|
10116299 |
Apr 4, 2002 |
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Current U.S.
Class: |
604/43 ;
604/6.16 |
Current CPC
Class: |
A61M 1/3661 20140204;
A61M 25/007 20130101; A61M 25/0032 20130101; A61M 2025/0031
20130101 |
Class at
Publication: |
604/043 ;
604/006.16 |
International
Class: |
A61M 003/00 |
Claims
What is claimed is:
1. A catheter comprising: an aspiration lumen and an infusion
lumen, a first one of said lumens having a distal annular lumen
segment circumferentially deployed around the second one of said
lumens, said annular lumen segment having an axis and a sidewall, a
distal port arrangement in said side wall comprising one or more
individual ports, each port of said port arrangement intersecting a
common plane, said common plane being substantially perpendicular
to said axis of said annular lumen segment, each of said ports has
an axis substantially perpendicular to said axis of said annular
lumen, said port arrangement constituting the sole ports of said
annular segment.
2. The catheter of claim 1 wherein: said ports are at the distal
end of said annular lumen segment.
3. The catheter of claim 1 wherein: said infusion lumen is said
annular lumen.
4. The catheter of claim 2 wherein: said infusion lumen is said
annular lumen.
5. The catheter of claim 1 wherein: each of said lumens has an
outer wall and wherein said distal port arrangement is in part
defined by segments of said annular lumen outer wall segments
extending between said ports and merging into said outer wall of
said second one of said lumens.
6. The catheter of claim 5 wherein: said ports are at the distal
end of said annular lumen segment.
7. The catheter of claim 5 wherein: said infusion lumen is said
annular lumen.
8. The catheter of claim 6 wherein: said infusion lumen is said
annular lumen.
9. The catheter of claim 1 wherein: wherein said distal port
arrangement comprises a set of triangular ports nested against each
other.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of pending
application Ser. No. 10/116,299 filed Apr. 4, 2002 entitled: Blood
Treatment Catheter And Method, the entire disclosure of which is
hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates in general to blood treatment
catheters and more particularly to a design for use in
hemo-dialysis in which blood clot build-up within the catheter
between uses of the catheter is minimized.
[0003] The hemo-dialysis catheter is maintained in the patient
between dialysis sessions. In order to avoid blood clot within the
catheter, a charge of heparinized saline is placed in the catheter
to displace the blood and prevent blood clot. This state is called
heparin lock.
[0004] In a typical catheter having a central aspirating lumen and
an annular infusion lumen, the openings near the distal end of the
infusion lumen are staggered axially. Accordingly, when the
heparinized saline is charged into the annular infusion lumen, one
of two things occur that negates the function of the heparinized
saline and tends to allow a blood clot to form.
[0005] In one situation, the heparinized saline exits from the
proximal most port thereby failing to displace the blood distal of
that exit port.
[0006] In another situation, the heparinized saline may be inserted
with sufficient flow speed to displace all of the blood in the
annular catheter. However, the patient's blood gradually circulates
through the openings in the annular lumen, displacing the
heparinized saline allowing a blood clot to develop over the zone
between proximal and distal openings.
[0007] The heparinized saline is locked into the lumens and this
state is often referred to as heparin lock. The blood clot at the
distal zone prevents the heparin lock from performing its
anti-clotting function at that zone.
[0008] Accordingly, it is an object of this invention to provide a
catheter design that maximizes the effect of the heparin lock.
[0009] Accordingly, it is a further purpose of this invention to
provide the above purpose in a design which provides a relatively
smooth surface to facilitate ease of insertion of the catheter into
the patient.
BRIEF DESCRIPTION OF THE FIGURES
[0010] FIG. 1 is a schematic illustration of the positioning of the
hemo-dialysis catheter 10 of this invention through the jugular
vein. In FIG. 1, the catheter is inserted into the patient at point
A and into the vein at point B.
[0011] FIG. 2 is an elevation view of an embodiment of the catheter
of this invention in which an annular lumen provides infusion and a
central lumen provides aspiration. Infusion ports 22 are at the
distal end of the infusion lumen. An aspiration port 36 is at the
distal end of the aspiration lumen.
[0012] FIG. 3 is an elevation view of the zone around the distal
infusion port of a first embodiment of the FIG. 2 catheter showing
a plurality of arcuate circumferential ports 22a; all of which
intersect a single radial plane.
[0013] FIG. 4 is a partial longitudinal sectional view along the
FIG. 3 catheter portion.
[0014] FIG. 5 is a cross-sectional view along the plane 5-5 of FIG.
3.
[0015] FIG. 6 is a longitudinal sectional view of a second
embodiment of the FIG. 2 catheter in which the infusion port
arrangement 22 is a circumferential port 22b interrupted by four
radial ribs 34 (see FIG. 8) that support the distal end of the
annular infusion tube.
[0016] FIG. 7 is a longitudinal sectional view through the ribs 34
of the FIG. 6 catheter.
[0017] FIG. 8 is a cross-sectional view along the plane 8-8 of FIG.
7 showing the four chamber section of the circumferential infusion
lumen immediately adjacent to the infusion port 22b.
[0018] FIG. 9 is an elevational view of a third embodiment showing
a set of triangular infusion ports.
[0019] FIG. 10 is a cross-sectional view along the plane 10-10 of
the FIG. 9 catheter.
DEFINITIONS
[0020] Infusion and Aspirating Port and Ports
[0021] The embodiments shown in FIGS. 3, 6, and 9 contain a
plurality of infusion exit ports. A design can be provided in which
there is a single circumferential exit port with upstream supports
for the annular lumen. The essential feature is that the port or
ports all lie along one plane that is substantially perpendicular
to the axis of the catheter.
[0022] Accordingly, it should be understood that, as applied to
either infusion or aspiration lumens, the terms "port" or "ports"
or "port arrangement" in the specification and claims are used to
include a single port and/or a set of ports.
BRIEF DESCRIPTION
[0023] In brief, the catheter disclosed has both aspiration and
infusion lumens. In the embodiments shown, at a distal zone, the
tube carrying the aspiration lumen extends distally of the end of
the tube defining the infusion lumen. At its distal end, the
infusion lumen is substantially annular, extending around the
aspiration tube and has one or more infusion ports that provide
emission of fluid all within a single plane.
[0024] All of the infusion ports are deployed along a single plane
that is substantially perpendicular to the axis of the catheter.
This infusion exit port arrangement serves to avoid blood clot
during heparin lock in the annular infusion tube.
[0025] All of the infusion ports face radially outward to minimize
having the port wall edges snag tissue and impede insertion into
the catheter.
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] FIGS. 1 and 2 illustrate the overall design of the catheter
10 embodying the invention.
[0027] In particular, a standard infusion tube 12 and aspiration
tube 14 are combined at a juncture 16 to provide a single tube 18
distal of the juncture 16. The tube 18 contains infusion and
aspiration lumens. The tube 18 is inserted into a patient at point
A and passed into the jugular vein 20 at point B to be positioned
at a desired location; often in the right atrium.
[0028] As can be seen in the embodiments shown in FIG. 3 through
10, the infusion lumen 24 is a circumferential lumen around the
aspiration lumen 26 in the zone that is immediately proximal of the
infusion exit port arrangement 22. A tubular wall 28 defines the
aspiration lumen 26. The infusion lumen 24 is defined by tubular
wall 28 as an inner wall and an outer wall 30. The port 22
arrangement is in the outer wall 30. The outer wall 30 terminates
or merges into the wall 28 at the built-up zone 32.
[0029] FIGS. 3 through 5 illustrate a first embodiment of this
invention in which the infusion port set 22 is constituted by four
circumferential ports 22a separated by small outer wall sections
30a. The port arrangement 22 is at the distal end of the annular
infusion lumen 24. The four ports 22a are along a single plane
which is substantially perpendicular to the axis of the annular
infusion lumen 24. The ports 22a face radially outward and thus the
central axis of each port 22a is substantially perpendicular to the
axis of the annular infusion lumen 24.
[0030] The small outer wall sections 30a merge into the wall 28 at
the built-up zone 32. Thus small segments 30a of the outer wall 30
extend through the infusion port zone 22 and define the ports 22a.
The approximate dimensions in one embodiment of the openings 22a
are 135 mils by 20 mils (0.135 inches by 0.020 inches) and the
segments 30b are 25 mils wide.
[0031] FIGS. 6 through 8 illustrate a second embodiment of this
invention in which the exit port arrangement 22 are four
circumferential ports 22b spaced apart by radial webs 34.
[0032] Over a portion of the exit port arrangement 22b, a web
design shown in FIG. 8, is employed at the exit ports 22b. This web
design assures that the ports 22b are maintained open and prevents
the wall 30 from collapsing onto the wall 28. This web design
involves four thin webs 34 which extend proximally from the ports
22b for about three millimeters in the embodiment shown.
[0033] The web 34 supports are not required in the design shown in
FIGS. 3-5. In that design, the outer wall 30 extends past the ports
22a to merge into the wall of the aspiration lumen and thus does
not require extra support.
[0034] It should be understood that the design of this invention
includes an embodiment in which the webs 34 extend the length of
the catheter from junction 16 to infusion exit ports 22. Such a
design is not presently preferred because it provides a stiffer
catheter with a lower flow rate than do the designs disclosed
herein.
[0035] FIGS. 9 and 10 show a third embodiment in which the ports
set 22 are a set of triangular ports 22c nested next to each other.
The ten wall segment 30b provides a sturdy structural support for
the distal end of the outer wall 30 while maximizing the
cross-sectional area and flow rate of each port.
[0036] The design of this invention avoids blood clot development
during heparin lock. When the catheter is implanted in a dialysis
patient and is not in use, it becomes important to avoid blood
clotting in the catheter. This is done by injecting a predetermined
amount of heparinized saline into the catheter while the catheter
is resident in the patient's body to essentially fill up the
interior of the catheter with heparinized saline. The heparinized
saline is held or locked into the lumens between dialysis
treatment. This is called heparin lock.
[0037] In the prior art designs employing co-axial lumens, the
outer annular lumen normally has a plurality of openings near the
distal end axially displaced from one another. The heparinized
saline fills up to the proximal most opening and then exits from
that opening and thus fails to fill the space distal of that
proximal most opening. A blood clot may form in that space,
blocking the openings. Alternatively, if the heparinized saline
does completely occupy the catheter lumen, the portion distal of
the most proximal hole will gradually be replaced by the patient's
blood and end up creating the blood clot that blocks the catheter
openings. Clot formation leads to reduced flow rates and may
require intervention to clear the catheter.
[0038] By having all the openings of the annular lumen aligned in a
single plane perpendicular to the axis of the lumen, the blood clot
problem that blocks certain of the ports is avoided. In each of the
embodiments shown, the infusion port set 22 are the only infusion
ports from the annular lumen 24.
[0039] Indeed, whether the annular lumen is used for infusion or
for aspiration, this co-planar alignment of openings avoids this
blood clot limitation on the heparin lock function. Although the
embodiments disclosed show that the annular lumen is the infusion
lumen, it should be understood that the invention has equal value
where the annular lumen is an aspiration lumen.
[0040] It is important that these co-planar openings face radially
outward rather than face partially forward. The radially outward
facing opening structure serves two purposes. First it minimizes
recirculation of filtered blood from the infusion opening to the
aspiration opening. Second, it assures a smoother surface to
facilitate insertion of the catheter.
[0041] In summary, to provide the above advantages, the geometry of
the openings have two important characteristics. A first is that
the surface of the openings are substantially parallel to the axis
of the catheter. The second is that the openings are all on a
common plane near the end of the annular lumen; which common plane
is substantially perpendicular to the axis of the catheter.
[0042] While the foregoing description and drawings represent the
presently preferred embodiments of the invention, it should be
understood that those skilled in the art will be able to make
changes and modifications to those embodiments without departing
from the teachings of the invention and the scope of the
claims.
* * * * *