U.S. patent application number 14/509102 was filed with the patent office on 2015-04-02 for implantable three-way diaphragm valve.
The applicant listed for this patent is THE JOHNS HOPKINS UNIVERSITY. Invention is credited to Soumyadipta Acharya, Brandon Doan, Sherri Jane Hall, Kelvin Hong, Yuan-Ping Li, Shishira Nagesh, Mary Katherine O'Grady, Thomas Reifsnyder, Thora Thorgilsdottir, Clifford R. Weiss.
Application Number | 20150094669 14/509102 |
Document ID | / |
Family ID | 47753733 |
Filed Date | 2015-04-02 |
United States Patent
Application |
20150094669 |
Kind Code |
A1 |
Li; Yuan-Ping ; et
al. |
April 2, 2015 |
IMPLANTABLE THREE-WAY DIAPHRAGM VALVE
Abstract
An embodiment in accordance with the present invention provides
a valve including a housing having a top portion and a bottom
portion. The top portion of the housing defines a first and second
nozzle, and the bottom portion of the housing defines an opening. A
diaphragm has an open position and a closed position, and the
diaphragm is disposed between the top portion of the housing and
the bottom portion of the housing. A first fluid flow path between
the first nozzle and the second nozzle is defined by the housing
and the diaphragm, when the diaphragm is in the closed position. A
second fluid flow path between the opening and the first nozzle is
defined by the housing and the diaphragm, when the diaphragm is in
the closed position. Such a valve can be used for a number of
purposes including hemodialysis procedures.
Inventors: |
Li; Yuan-Ping; (Duluth,
GA) ; Hall; Sherri Jane; (Baltimore, MD) ;
Hong; Kelvin; (Woodstock, MD) ; Nagesh; Shishira;
(Baltimore, MD) ; O'Grady; Mary Katherine;
(Baltimore, MD) ; Reifsnyder; Thomas; (Baltimore,
MD) ; Thorgilsdottir; Thora; (Baltimore, MD) ;
Weiss; Clifford R.; (Annapolis, MD) ; Doan;
Brandon; (Peoria, AZ) ; Acharya; Soumyadipta;
(Baltimore, MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE JOHNS HOPKINS UNIVERSITY |
Baltimore |
MD |
US |
|
|
Family ID: |
47753733 |
Appl. No.: |
14/509102 |
Filed: |
October 8, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13487590 |
Jun 4, 2012 |
8882694 |
|
|
14509102 |
|
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|
|
61493021 |
Jun 3, 2011 |
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Current U.S.
Class: |
604/256 |
Current CPC
Class: |
A61M 1/3656 20140204;
A61M 39/223 20130101; A61M 39/10 20130101; A61M 2039/0258 20130101;
A61M 39/22 20130101; A61M 39/227 20130101; A61M 39/0247 20130101;
A61M 2039/0009 20130101; A61M 1/3655 20130101; A61M 1/3653
20130101; A61M 2039/0264 20130101; A61F 2/06 20130101; A61M
2039/027 20130101; A61M 2039/0276 20130101 |
Class at
Publication: |
604/256 |
International
Class: |
A61M 39/22 20060101
A61M039/22; A61M 39/02 20060101 A61M039/02; A61M 39/10 20060101
A61M039/10; A61M 1/36 20060101 A61M001/36 |
Claims
1.-14. (canceled)
15. A valve for use in a hemodialysis device comprising: a housing
having a top portion and a bottom portion; a first nozzle defined
by the top portion; a second nozzle defined by the top portion; an
opening defined by the bottom portion of the housing; a diaphragm
having an open position and a closed position, said diaphragm being
disposed between the top portion of the housing and the bottom
portion of the housing; a first fluid flow path between the first
nozzle and the second nozzle, said first fluid flow path being
defined by the housing and the diaphragm, when the diaphragm is in
the closed position, and wherein the diaphragm completely occludes
the opening defined by the bottom portion of the housing in the
closed position; and a second fluid flow path between the opening
and the first nozzle, said second fluid flow path being defined by
the housing and the diaphragm, when the diaphragm is in the open
position, and wherein the diaphragm completely occludes the second
nozzle in the open position.
16. The valve of claim 15 wherein the bottom portion of the housing
further comprises a skirt configured to be secured to a
large-diameter blood vessel.
17. The valve of claim 15 wherein the top portion of the housing
has ridges along an outer surface of the top portion of the
housing.
18. The valve of claim 15 wherein the valve further comprises a
fluted opening to direct the flow of blood.
19. The valve of claim 15 wherein the first nozzle and the second
nozzle comprise connectors.
20. The valve of claim 19 wherein the connectors are selected from
one of a group consisting of barbed, press-fit, friction, twist and
lock, luer, and threaded.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 61/493,021, filed Jun. 3, 2011, which is
incorporated by reference herein, in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to renal therapy.
More particularly, the present invention relates to a valve for
facilitating hemodialysis.
BACKGROUND OF THE INVENTION
[0003] Approximately 300,000 patients undergo hemodialysis in the
United States alone, with approximately 100,000 new hemodialysis
patients being added each year. In order to perform hemodialysis,
vascular access to the patient's blood stream is required.
Currently, the options for permanent hemodialysis access are
fistulas and grafts, which generally speaking are abnormal
connections made between a peripheral artery and vein. Such
connections essentially bypass the capillary system, thereby
providing the larger flow rates required for hemodialysis. However,
the life span of grafts and fistulas are low: 3 to 4 years for
fistulas and 1.5 years for grafts.
[0004] Also, these connections require many interventions during
their lifespan, which not only increases morbidity, but also adds
large costs to the healthcare system. The failure of these
connections is related to the development of stenosis due to
constant large flow rates. After, repeated surgeries an access site
will fail and a new access site is used until no access sites are
left. A lack of remaining access sites accounts for 18% of
hemodialysis patient mortality. In addition, innovation related to
vascular access for hemodialysis has focused on incremental
improvements to grafts and catheters, with little to no development
of alternative methods and devices.
[0005] It would therefore be advantageous to provide a valve to
facilitate hemodialysis that does not require the connection of an
artery and vein using a graft or fistula.
SUMMARY OF THE INVENTION
[0006] The foregoing needs are met, to a great extent, by the
present invention, wherein in one aspect, a valve includes a
housing having a top portion and a bottom portion. The top portion
of the housing defines a first nozzle and a second nozzle. The
bottom portion of the housing defines an opening. The valve also
includes a diaphragm having an open position, such that the
diaphragm sits in a valve seat defined by the top portion of the
housing. The diaphragm also has a closed position, such that the
diaphragm sits in a valve seat defined by the bottom portion of the
housing. The diaphragm is disposed between the top housing portion
and the bottom housing portion.
[0007] In accordance with another aspect of the present invention
the valve includes a first fluid flow path between the first nozzle
and the second nozzle. The first fluid flow path is defined by the
housing and the diaphragm, when the diaphragm is in the closed
position. A second fluid flow path between the opening and the
first nozzle is defined by the housing and the diaphragm, when the
diaphragm is in the closed position. The diaphragm is configured to
be movable from the open position to the closed position using
positive pressure. The diaphragm further is movable from the closed
position to the open position using negative pressure.
[0008] According to another aspect of the present invention, the
housing and diaphragm are formed from biocompatible materials, and
the diaphragm can be formed from an implantable grade silicone.
Additionally, the diaphragm being coated with an antithrombogenic
material or ePTFE. The bottom portion of the housing further
includes a skirt configured to be secured to tissue. The skirt is
formed from a material selected from one of the group consisting of
Dacron and PTFE. The top portion of the housing has ridges along an
outer surface of the top portion of the housing. A fluted opening
can also be included to direct the flow of blood. The first and
second nozzles can include connectors, such as barbed, press-fit,
friction, twist and lock, luer, and threaded connectors.
[0009] In accordance with yet another aspect of the present
invention, a valve for use in a hemodialysis device includes a
housing having a top portion and a bottom portion. The top portion
of the housing defines a first and second nozzle, and the bottom
portion of the housing defines an opening. A diaphragm has an open
position and a closed position, and the diaphragm is disposed
between the top portion of the housing and the bottom portion of
the housing. A first fluid flow path between the first nozzle and
the second nozzle is defined by the housing and the diaphragm, when
the diaphragm is in the closed position. A second fluid flow path
between the opening and the first nozzle is defined by the housing
and the diaphragm, when the diaphragm is in the closed
position.
[0010] In accordance with still another aspect of the present
invention, the bottom portion of the housing further includes a
skirt configured to be secured to a large-diameter blood vessel.
The top portion of the housing has ridges along an outer surface of
the top portion of the housing. The valve further includes a fluted
opening to direct the flow of blood. The first nozzle and the
second nozzle can further include connectors, such as barbed,
press-fit, friction, twist and lock, luer, and threaded
connectors.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings provide visual representations
which will be used to more fully describe the representative
embodiments disclosed herein and can be used by those skilled in
the art to better understand them and their inherent advantages. In
these drawings, like reference numerals identify corresponding
elements and:
[0012] FIG. 1 illustrates a side view of a valve assembly,
according to an embodiment of the invention.
[0013] FIG. 2 illustrates a partially sectional view of the valve
assembly and a diaphragm disposed within the valve assembly,
according to the embodiment of the invention illustrated in FIG.
1.
[0014] FIG. 3 illustrates a first side view of an outer housing
according to an embodiment of the invention.
[0015] FIG. 4 illustrates a second side view of the outer housing
according to the embodiment of the invention illustrated in FIG.
3.
[0016] FIG. 5 illustrates a top down view of the outer housing
according to the embodiment of the invention illustrated in FIGS. 3
and 4.
[0017] FIG. 6 illustrates a perspective view of an inner housing
according to the embodiment of the invention illustrated in FIGS.
3-5.
[0018] FIG. 7 illustrates a perspective view of a lower housing
according to an embodiment of the invention.
[0019] FIG. 8 illustrates a perspective view of a valve according
to an embodiment of the invention.
[0020] FIG. 9 illustrates a partially sectional view of an open
valve according to an embodiment of the invention.
[0021] FIGS. 10 illustrates a partially sectional view of a closed
valve according to an embodiment of the present invention.
[0022] FIG. 11 illustrates a perspective view of a hemodialysis
device according to an embodiment of the invention.
[0023] FIG. 12 illustrates a top down view of a triple-port
according to an embodiment of the invention.
[0024] FIG. 13 illustrates a hemodialysis device conducting
dialysis according to an embodiment of the present invention.
[0025] FIG. 14 illustrates a hemodialysis device configured for
cleaning according to an embodiment of the present invention.
DETAILED DESCRIPTION
[0026] The presently disclosed subject matter now will be described
more fully hereinafter with reference to the accompanying Drawings,
in which some, but not all embodiments of the inventions are shown.
Like numbers refer to like elements throughout. The presently
disclosed subject matter may be embodied in many different forms
and should not be construed as limited to the embodiments set forth
herein; rather, these embodiments are provided so that this
disclosure will satisfy applicable legal requirements. Indeed, many
modifications and other embodiments of the presently disclosed
subject matter set forth herein will come to mind to one skilled in
the art to which the presently disclosed subject matter pertains
having the benefit of the teachings presented in the foregoing
descriptions and the associated Drawings. Therefore, it is to be
understood that the presently disclosed subject matter is not to be
limited to the specific embodiments disclosed and that
modifications and other embodiments are intended to be included
within the scope of the appended claims.
[0027] An embodiment in accordance with the present invention
provides a valve including a housing having a top portion and a
bottom portion. The top portion of the housing defines a first and
second nozzle, and the bottom portion of the housing defines an
opening. A diaphragm has an open position and a closed position,
and the diaphragm is disposed between the top portion of the
housing and the bottom portion of the housing. At any one time two
of the first and second nozzle and opening are open and one is
closed. A first fluid flow path between the first nozzle and the
second nozzle is defined by the housing and the diaphragm, when the
diaphragm is in the closed position. A second fluid flow path
between the opening and the first nozzle is defined by the housing
and the diaphragm, when the diaphragm is in the closed position.
Such a valve can be used for a number of purposes including
hemodialysis procedures.
[0028] FIG. 1 illustrates a side view of a valve assembly 10,
according to an embodiment of the invention. As illustrated in FIG.
1, the valve assembly 10 includes a housing 12 having a top portion
14 and a bottom portion 16. The housing can be formed from a
semi-rigid silicone or other semi-stiff material. The top portion
14 includes a first nozzle 18 and a second nozzle 20. The first and
second nozzles 18 and 20 can take the form of connectors, such as a
barbed connector, press-fit connector, frictional connector,
twist-and-lock connector, or any other suitable configuration known
to one of skill in the art. The bottom portion 16 includes a skirt
22. The skirt 22 can be used to secure the valve assembly 10 to a
blood vessel or other tissue of a patient. The skirt can be formed
from a Dacron.TM., ePTFE, or any other flexible and easily
suturable material known in the art that would be suitable for
suturing the skirt 22 to a vessel or other tissue. The components
can be preassembled or can be assembled during implantation.
[0029] FIG. 2 illustrates a partially sectional view of a valve
assembly 10, according to the embodiment of the invention
illustrated in FIG. 1. As illustrated in FIG. 2, the valve assembly
10 includes a housing 12 surrounding a diaphragm 24. The housing 12
can include a two-piece construction having top-portion 14 and
bottom portion 16. The housing 12 is illustrated as having a
generally spherical shape, but any other suitable shape could be
used. The top-portion 14 and the bottom-portion 16 can be coupled
together, such that the diaphragm 24 is sandwiched between them.
The diaphragm 24 is biased into a closed position, such that the
first and second nozzles 18, 20 are open to fluid flow and form a
flow path between them. As noted above, with respect to FIG. 1, the
housing can be formed from a semi-stiff silicone or other soft and
semi-stiff material and the valve can be formed from durable
silicone or a silicone-like material with an ePTFE coating at the
surface 26 of the valve that is in contact with a flow of blood
through the large-diameter vein. It should be noted that any
suitable materials or coating that are known to one of ordinary
skill in the art could also be used to construct the valve. Any
material used should be configured to tolerate sterilization
methods such as ethyleneoxide, gamma irradiation, or autoclaving.
The components of the valve assembly 10 can be formed in any number
of ways known to one of skill in the art, such as molding.
Additionally the components of the valve assembly 10 can be joined
in any way known to one of skill in the art, such as, but not
limited to heat sealing, securing with a fastener, or adhesive.
[0030] As illustrated in FIG. 2, the first nozzle 18 directs the
flow of fluid into or out of the valve assembly 10. The second
nozzle 20 is incorporated into the housing 12 such that the valve
assembly 10 can be opened and closed with fluid pressure and
cleaning fluid can be introduced into the system. As illustrated in
FIG. 2, the first nozzle 18 can include a fluted flow channel 28,
which funnels fluid immediately to reduce the shear stress that the
diaphragm 24 is exposed to and in turn increases the stability of
the diaphragm 24. The first and second nozzles 18 and 20 can be
arranged in parallel as illustrated in FIG. 2 or perpendicularly,
as illustrated in FIG. 11, described below.
[0031] Further, as illustrated in FIG. 2, the bottom-portion 16 of
the housing 12 includes the flap or skirt 22 that can be formed
from a Dacron, ePTFE, or any other flexible and easily sutured
material known in the art. When implanted for use with
hemodialysis, a 1 cm incision is made to the vein and the skirt 22
is sutured to the edges of the incision. The skirt 22 is flexible,
but pre-shaped to fit flush with the preferably 7-9 mm vein. When
the diaphragm 24 is in the closed position, it is tight against the
lower housing, and flush with the anastomosed skirt, allowing for
undisturbed blood-flow past the device when off-dialysis.
[0032] FIG. 3 illustrates a first side view of an outer housing
according to an embodiment of the invention, and FIG. 4 illustrates
a second side view of the outer housing according to the embodiment
of the invention illustrated in FIG. 3. FIG. 5 illustrates a top
down view of the outer housing according to the embodiment of the
invention illustrated in FIGS. 3 and 4, and FIG. 6 illustrates a
perspective view of an inner housing according to the embodiment of
the invention illustrated in FIGS. 3-5. In the embodiment
illustrated in FIGS. 3, 4, and 5, the housing 12 includes the
top-portion 14 that includes first and second nozzles 18 and 20.
The top-portion 14 also preferably includes ridges 30 that enhance
the ridgidity of the housing. FIGS. 4 and 6 further illustrate the
structure of the flow channel 28, which directs the flow of fluid
into and out of the valve assembly 10. The flow channel 28 is
preferably fluted in shape to guide the direction of the flow of
blood.
[0033] FIG. 7 illustrates a perspective view of the bottom portion
16 of the housing 12, according to an embodiment of the invention.
The bottom-portion 16 includes the skirt 22 that can be anastomosed
to the large-diameter vein, as illustrated in FIG. 11, or attached
to any other suitable tissue known to one of skill in the art. When
the valve (not shown) is in the open position, fluid can flow
through the opening 38 defined by the bottom-portion 16 of the
housing 12. The bottom-portion 16 of the housing 12 couples with
the top-portion (not shown), in order to sandwich the diaphragm
(not shown) in between the two portions of the housing 12.
Therefore, both the bottom-portion 16 and the top-portion (not
shown) are configured to be coupled, to form a fluid-tight
structure surrounding the diaphragm 24.
[0034] FIG. 8 illustrates a perspective view of a valve according
to an embodiment of the invention. As described above, the
diaphragm 24 is configured to sit between the top-portion (not
shown) of the housing 12 and the bottom-portion (not shown) of the
housing 12. The diaphragm 24 is further configured to have
hang-down 32 that is flush with the skirt (not shown), when the
diaphragm 24 is in the closed position. The diaphragm 24 also
defines an opening 34, through which the flow channel (not shown)
extends, when the diaphragm 24 is in an open position. This helps
to secure the valve in place between the top-portion (not shown)
and the bottom-portion (not shown) of the housing (not shown) and
also allows for the flow of blood through the valve and out of the
valve assembly (not shown) through nozzle (not shown).
[0035] FIG. 9 illustrates a sectional view of the valve assembly 10
having an open diaphragm 24, according to an embodiment of the
invention and FIG. 10 illustrates a sectional view of the valve
assembly 10 having a closed diaphragm 24, according to an
embodiment of the present invention. As described above, when
negative pressure is applied to the diaphragm 24, the diaphragm 24
is opened, as illustrated in FIG. 9, and when positive pressure is
applied to the diaphragm 24, the diaphragm 24 is closed, as
illustrated in FIG. 10. The diaphragm 24 is biased to be in the
closed position. FIGS. 9 and 10 both show the diaphragm 24 disposed
within housing 12 of the valve assembly 10. As described with
respect to FIG. 8, the diaphragm 24 defines an opening 34 which,
when the diaphragm 24 is open, as in FIG. 9, blood can flow through
the opening 34 and through first nozzle 18. In turn, when the
diaphragm 24 is closed, as in FIG. 10, the diaphragm 24 is pressed
against the bottom portion 16 of the housing 12, such that the
opening 34 defined by the bottom portion of the housing is sealed
against the flow of liquid between the valve assembly 10 and the
large-diameter vein 36.
[0036] An exemplary use for the implantable three-way valve
described above is as a component of a hemodialysis system. A
description of such a hemodialysis system is included herein.
However, this exemplary embodiment is not meant to be limiting and
the implantable three-way diaphragm valve can be used for any
suitable purpose known to one of skill in the art.
[0037] FIG. 11 illustrates a perspective view of a hemodialysis
device according to an embodiment of the invention. As illustrated
in FIG. 11, the hemodialysis device 100 is shown anastomosed to a
large-diameter vein 112 such as the femoral vein. The hemodialysis
device 100 includes a first valve assembly 114 and a second valve
assembly 116 which are both anastomosed to the vein 112. The device
100 also includes a needle-access port 118 that is coupled to the
first valve assembly 114 with a first elongate inlet tube 120 and
is coupled to the second valve assembly 116, via a second elongate
outlet tube 122.
[0038] Additionally, as illustrated in FIG. 11, the first elongate
inlet tube 120 includes a first lumen 124 and a second lumen 126
and the second elongate outlet tube 122 also includes a first lumen
128 and a second lumen 130. A first end 132 of the first lumen 124
of the first elongate inlet tube 120 couples to a first nozzle 134
on the first valve assembly 114, and a first end 138 of the second
lumen 126 couples to a second nozzle 136 on the first valve
assembly 114. Similarly, a first end 140 of the first lumen 128 of
the second elongate outlet tube 122 couples to a first nozzle 142
on the second valve assembly 116, and a first end 144 of the second
lumen 130 couples to a second nozzle 146 on the second valve
assembly 116. All of the tubing can be formed from flexible 3-6 mm
diameter silicone or silicone-like tubes, with 0.5-1.5 mm wall
thickness and include bioengineered collapse prevention.
Alternately, the tubing can be formed from any other suitable
material known to one of skill in the art.
[0039] As illustrated in FIGS. 11 and 12, which illustrates a top
down view of a triple-port according to an embodiment of the
invention, the needle valve port 118 includes a first septum 148, a
second septum 150, and a third septum 152. The first septum 148
couples to a second end 155 of the first lumen 124 of the first
elongate inlet tube 120, and the second septum 150 is coupled to a
second end 157 of the first lumen 128 of the second elongate outlet
tube 122. Therefore, the first septum 148 and the second septum 150
are in fluid communication with a stream of blood traveling through
the large-diameter vein 112. In addition, the third septum 152 is
coupled to second ends 158, 160 of the second lumens 126, 130 of
the first and second elongate inlet and outlet tubes 120, 122. The
joined region of second lumens 126 and 130 can also be referred to
as a connecting bridge. Therefore, the third septum 152 is in fluid
communication with the first and second valve assemblies 114, 116
and, in turn, is in fluid communication with the first lumens 124,
128 of the first and second elongate inlet and outlet tubes 120,
122. The third septum 152 can be used to open and close valve
assemblies 114 and 116 using fluid pressure, and can also be used
as the hub for injecting and draining a biocompatible cleaning
solution from the system.
[0040] Further, as illustrated in FIGS. 11 and 12 septa 148 and 150
are larger in size than the third septum 152. The first and second
septa 148 and 150 are configured to be tolerant to multiple needle
sticks with 14-17 gauge hemodialysis needles. These septa 148 and
150 are large to provide durability for large needle sticks.
However, the first and second septa 148 and 150 can also be
optimized to have smooth, angled surfaces for patient comfort. The
third septum 152 is configured for controlling the valve assemblies
114 and 116. Saline can be pushed into or drained from the third
septum 152 through a 22-25 gauge needle. The housing of the needle
port 118 can be formed from titanium or a biocompatible polymer and
puncture beds 154, 156, and 158 can be formed from a thick silicone
or silicone-like layers that seal off around the needle after
dialysis is completed. While this embodiment has been described in
detail above, it should be known that any configuration known to
one of ordinary skill in the art could be used to achieve these
results and the above description should not be considered
limiting.
[0041] FIG. 13 illustrates a hemodialysis device conducting
dialysis according to an embodiment of the present invention. As
illustrated in FIGS. 11 and 13 the valve assemblies 114 and 116 of
the hemodialysis device 100 are anastomosed to a large-diameter
vein 112. As illustrated by first flow direction arrow 178, shown
in FIG. 12, blood flowing through the large-diameter vein 112
travels in through valve assembly 114, through the first lumen 124
of the first elongate inlet tube 120, and out through the first
septum 148 of the needle port 118 for hemodialysis processing.
After hemodialysis processing is complete, the blood flows back in
as illustrated by second flow direction arrow 180. Flow direction
arrow 180 follows a path in through the second septum 150 of the
needle port 118 through the first lumen 128 of the second elongate
outlet tube 122 into valve assembly 116 and back into the
large-diameter vein 112.
[0042] FIG. 14 illustrates a hemodialysis device configured for
cleaning according to an embodiment of the present invention.
During cleaning the valve assemblies 114 and 116 are closed to
blood flow from the large-diameter vein 112, via the injection of
fluid into the third septum 152 of the needle port 118. A cleaning
solution can be injected into the device via the first septum 148
of the needle port 118. The cleaning solution follows a cleaning
solution flow path 182 in through the first lumen 124 of the first
elongate inlet tube 120 into closed valve assembly 114 into the
second lumen 126 of the first elongate inlet tube 120 across bridge
184 and into the second lumen 130 of the second elongate outlet
tube 122. The path 182 continues through the valve assembly 116 and
into the first lumen 128 of the second elongate outlet tube 122 and
then out through the second septum 150 of the needle port 118.
[0043] The many features and advantages of the invention are
apparent from the detailed specification, and thus, it is intended
by the appended claims to cover all such features and advantages of
the invention which fall within the true spirit and scope of the
invention. Further, since numerous modifications and variations
will readily occur to those skilled in the art, it is not desired
to limit the invention to the exact construction and operation
illustrated and described, and accordingly, all suitable
modifications and equivalents may be resorted to, falling within
the scope of the invention.
[0044] Although the present invention has been described in
connection with preferred embodiments thereof, it will be
appreciated by those skilled in the art that additions, deletions,
modifications, and substitutions not specifically described may be
made without departing from the spirit and scope of the invention
as defined in the appended claims.
* * * * *