U.S. patent application number 13/349233 was filed with the patent office on 2012-05-03 for swabbable needle-free injection port valve system with zero fluid displacement.
Invention is credited to Dana Wm. Ryan.
Application Number | 20120109077 13/349233 |
Document ID | / |
Family ID | 38309903 |
Filed Date | 2012-05-03 |
United States Patent
Application |
20120109077 |
Kind Code |
A1 |
Ryan; Dana Wm. |
May 3, 2012 |
Swabbable Needle-Free Injection Port Valve System With Zero Fluid
Displacement
Abstract
An improved needle-free intravenous injection port assembly is
disclosed. Embodiments include a boot valve with a helical surface,
a boot valve and septum which mate with mechanical interference, a
spike with a rough outer surface coated with a lubricant, a septum
having a shoulder and a single continuous swabbable surface, a
septum and a boot valve which are pre-punctured, a septum with a
frustroconical extension and a combination single piece septum and
boot valve. The injection port assembly provides zero fluid
displacement during coupling and uncoupling.
Inventors: |
Ryan; Dana Wm.;
(Nolensville, TN) |
Family ID: |
38309903 |
Appl. No.: |
13/349233 |
Filed: |
January 12, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12428678 |
Apr 23, 2009 |
8096525 |
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13349233 |
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11341119 |
Jan 26, 2006 |
7530546 |
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12428678 |
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10756601 |
Jan 13, 2004 |
6994315 |
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11341119 |
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Current U.S.
Class: |
604/246 ;
604/265; 604/535 |
Current CPC
Class: |
A61M 2039/267 20130101;
F16K 51/00 20130101; Y10S 604/905 20130101; A61M 39/26
20130101 |
Class at
Publication: |
604/246 ;
604/535; 604/265 |
International
Class: |
A61M 25/16 20060101
A61M025/16; A61L 15/50 20060101 A61L015/50; A61M 25/14 20060101
A61M025/14 |
Claims
1. An injection port assembly for coupling to and uncoupling from a
first fluid pathway of a first connector and for coupling to a
device provided with a second connector so as to provide a fluid
connection between the first and second connectors, said injection
port assembly comprising: a body having a first mating structure
adapted to mate with the first connector and a second mating
structure coupled to said first mating structure and adapted to
mate with the second connector, a resilient barrier substantially
contained within said body and compressible from a first position
in which fluid flow between said first mating structure and said
second mating structure is blocked to a more compressed second
position in which fluid flow between said first mating structure
and said second mating structure is permitted, said resilient
barrier having an outer wall with a generally helical surface
pattern and having a constant outer diameter along a majority of
its length.
2. An injection port assembly according to claim 1, wherein: said
resilient barrier increases in thickness by having an inner wall
which tapers while said outer wall is constant in diameter.
3. An injection port assembly according to claim 1, wherein: said
inner wall is polygonal.
4. An injection port assembly according to claim 1, further
comprising: said resilient barrier includes a boot valve totally
contained within said body and a septum at least mostly contained
within said body.
5. An injection port assembly according to claim 1, further
comprising: a spike coupled to said body and mounted within said
resilient barrier.
6. An injection port assembly for coupling to and uncoupling from a
first fluid pathway of a first connector and for receiving and
passing a fluid into the first fluid pathway from a device provided
with a second connector, said injection port assembly comprising:
a) a body having a first end provided with a first mating structure
adapted to mate with the first connector, and a second end provided
with a second mating structure adapted to removably couple to the
second connector; b) a hollow spike coupled to and at least
partially surrounded by said body, said hollow spike having a
penetrating tip, said first mating structure and said hollow spike
being in fluid communication with each other; and c) a resilient
barrier substantially contained within said body and extending over
said spike and having a tip portion about said tip of said spike,
wherein said resilient barrier is always in compression in said
body, and when the second connector is coupled to said second
mating structure, said second connector forces said tip portion of
said resilient barrier over said spike such that said second
connector and said first connector are in fluid communication with
each other through said hollow spike and said first mating
structure.
7. An injection port assembly according to claim 6, wherein: said
resilient barrier includes a boot valve totally contained within
said body and a septum at least mostly contained within said
body.
8. An injection port assembly according to claim 7, wherein: said
resilient barrier having a generally helical outer surface pattern
along at least a portion of its length.
9. An injection port assembly according to claim 8, wherein: said
resilient barrier has a polygonal inner surface along at least a
portion of its length.
10. An injection port assembly for coupling to and uncoupling from
a first fluid pathway of a first connector and for receiving and
passing a fluid into the first fluid pathway from a device provided
with a second connector, said injection port assembly comprising: a
body having a first mating structure adapted to mate with the first
connector and a second mating structure coupled to said first
mating structure and adapted to mate with the second connector, a
resilient barrier substantially contained within and always in
compression within said body, and compressible by said device
during coupling of said second connector with said second mating
structure with zero fluid displacement during coupling from a first
position in which fluid flow between said first mating structure
and said second mating structure is blocked to a more compressed
second position in which fluid flow between said first mating
structure and said second mating structure is permitted,
11. An injection port assembly according to claim 10, further
comprising: a spike coupled to said body and mounted within said
resilient barrier, said spike having a tip, and said resilient
barrier in interfering contact with said tip.
12. An injection port assembly according to claim 11, said spike
has a roughened surface which is covered with a lubricant.
13. A method for coupling and uncoupling a device to a fluid
pathway, said method comprising: coupling an injection port
assembly having a resilient valve to the fluid pathway, coupling
the device to the injection port assembly such that the resilient
valve is opened putting the device in fluid communication with the
fluid pathway with zero fluid displacement during coupling; and
uncoupling the device from the injection port assembly such that
the resilient valve is closed and the device is no longer in fluid
communication with the fluid pathway with zero fluid displacement
during uncoupling.
Description
[0001] This application is a divisional of pending application U.S.
Ser. No. 12/428,678, filed Apr. 23, 2009, to be issued on Jan. 17,
2012, as U.S. Pat. No. 8,096,525, which is a divisional of
application U.S. Ser. No. 11/341,119, filed Jan. 26, 2006, and
issued on May 12, 2009, as U.S. Pat. No. 7,530,546, which is a
continuation-in-part of U.S. Ser. No. 10/756,601, filed Jan. 13,
2004, and issued on Feb. 7, 2006, as U.S. Pat. No. 6,994,315, the
complete disclosures of which are hereby incorporated herein by
reference. This application also relates to U.S. Pat. No.
6,113,068, issued Sep. 5, 2000, the complete disclosure of which is
hereby incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to medical intravenous administration
line connectors. More particularly, this invention relates to
needle-free intermittent injection ports for the safe infusion
and/or aspiration of fluids in intravenous and blood administration
therapy.
[0004] 2. State of the Art
[0005] Intravenous fluid therapy for parenteral administration or
blood sampling in healthcare facilities routinely uses intermittent
injection port connectors. These connectors or adapters are
connected to a vascular access device such as a peripherally
inserted central venous catheter (PICC), central venous catheter
(CVC), femoral catheter, Huber needle for implantable ports,
peripheral intravenous catheter (PIV), catheter and intravenous
extension set, or intravenous administration set. The intermittent
injection port connector allows the infusion therapist a means to
infuse fluids or aspirate the patient's blood through the connector
without having to stick the patient with a needle each time.
[0006] Traditionally, healthcare providers worldwide have used an
intermittent injection port connector utilizing a latex septum or
barrier requiring a hollow steel needle attached to a syringe or
intravenous line set to pierce the resilient latex septum opening
up a fluid channel to the patient. Since the discovery in the
mid-1980's of the virus that causes AIDS, and the possibility of
this virus being transmitted to the healthcare provider via an
accidental needlestick injury, a major change within the medical
device industry has taken place. Although hepatitis B and C are
still the leading concern among healthcare professionals via an
accidental needlestick injury, the emotional concern of the
possibility of contracting AIDS through contaminated needles has
been the catalyst for change in the industry.
[0007] Since the mid 1980's, various design innovations have solved
the accidental needlestick injury crisis among healthcare
professionals. However, two critical catheter management issues
have been on the rise; i.e., interluminal thrombotic catheter
occlusions, and catheter related blood stream infections (CRBSIs).
Now that healthcare professionals are comfortable that they are
protected from accidental needlestick injuries when they use these
types of safety injection port systems, they are beginning to focus
on the patient safety aspects of these products; i.e., to overcome
occlusions and CRBSIs. It is clear that a new generation of
intermittent injection port designs is needed to improve and
resolve concerns such as microbial ingress, ineffective patient
fluid pathway protection, negative fluid displacement retrograding
blood up into the catheter lumen, septum seal integrity, and other
critical functional features.
[0008] Co-owned U.S. Pat. No. 6,113,068 focuses on improving upon
the critical microbial barrier performance and functional
attributes important for overall patient safety. After manufacture,
it effectively provides a single piece injection port with standard
male-luer connectors, i.e. universal access. No extra adapters,
components, or end caps are required, thereby reducing the overall
cost to deploy the system throughout the healthcare facility. The
upper septum is swabbable and easy to disinfect. There are no gaps
between the septum and the outer body opening, thereby improving
septum seal integrity. This prevents gross particulate
contamination from entering into the internal body of the valve,
thereby minimizing downstream contamination. The injection port
cannot be used with non-safety hollow bore needles, thereby
complying with OSHA guidelines and mandates. The double microbial
barrier design is an effective barrier to pathogen ingress. The
combination of the double resilient barriers (the upper resilient
septum and the lower resilient boot valve) and their association
with the hollow bore spike and centering component significantly
reduce the negative fluid displacement to a negligible 0.0035 mL,
which is significantly reduced relative to all other currently
available needle-free connector systems. The plastic centering
component captures both barriers allowing the double barriers to
move freely along the inner wall of the outer body and to keep the
slits axially aligned with the spike tip and shaft. The
straight-through fluid path eliminates the tortuous paths found in
many prior art devices. Priming volume is reduced to only 0.034 mL
of fluid which is one of the smallest volumes for swabbable
injection port connectors. Activation force to fully access the
valve is approximately 5.5 lbs, an acceptable amount for the
clinician while providing excellent snap-back and resealing
characteristics. In the device described in my prior patent, fluid
flow at gravity averaged 7,500 mL per hour thereby exceeding the
ISO standard of 6,000 mL per hour with the fluid source at one
meter above the valve. In the manufacturing process, after assembly
of all the components and the sonic-welding of the two outer
bodies, an ISO male luer fixture could be used to initially
pre-puncture the two silicone barriers. As the male luer fixture is
attached to the injection port assembly, the internal spike
punctures the two silicone barriers and distributes the liquid
silicone lubricant along the puncture axes in the two barriers.
[0009] Although the invention which is described in U.S. Pat. No.
6,133,068 improved upon many of the desired patient safety
attributes for a swabbable injection port connector system, the
prior design may be improved.
SUMMARY OF THE INVENTION
[0010] It is therefore an object of the invention to provide a
needle-free medical valve injection port which is safe,
efficacious, and easy to use. It is also an object of the invention
to provide an injection port valve system which is swabbable and
provides an excellent microbial ingress barrier protection.
[0011] It is another object of the invention to provide an
injection port valve system which has less than 0.002 mL fluid
displacement during both the "connection to" and "disconnection
from" the medical valve.
[0012] It is an additional object of the invention to provide an
injection port valve system which has a zero fluid displacement to
minimize blood being refluxed or retrograded into a vascular access
device lumen during both the "connection to" and "disconnection
from" the medical valve. For purposes herein, the term "zero fluid
displacement" is defined as fluid displacement of 0.000 mL with a
small tolerance of .+-.0.002 mL upon attachment (connection) and
detachment (disconnection) of the port valve system from a line
connector.
[0013] It is a further object of the invention to provide an
injection port valve system which has improved snap-back
characteristics in repeated use over the life cycle of the product
to minimize fluid leakage and/or microbial ingress.
[0014] Another object of the invention is to provide an injection
port valve system which minimizes dead space within the fluid
pathway thereby reducing the probability of downstream
contamination and improving the flushing capabilities of the
medical valve.
[0015] A further objective of the invention is to provide an
injection port valve system which has excellent leak resistant
characteristics of repeated use during its life cycle.
[0016] An additional object of the invention is to provide an
injection port valve system which improves the lubrication of the
spike shaft, spike tip, and the puncture axis geometry to minimize
coring of the two resilient microbial barriers during repeated
use.
[0017] Yet another object of the invention is to provide an
injection port valve system which has improved back-pressure leak
resistant capabilities.
[0018] It is even a further object of the invention to provide an
injection port valve system which is easy to use and activate by
reducing the overall activation force required.
[0019] In accord with these objects, which will be discussed in
detail below, an injection port valve system according to the
invention has five total components: an upper plastic outer body
with ISO compliant threads ("the female luer body"), a lower
plastic outer body with an integrally formed unitary hollow spike
and an ISO compliant male luer lock in fluid communication with the
spike ("the spike body"), an upper resilient barrier ("the
septum"), a plastic centering and barrier cage ("the H-guide"), and
a lower resilient barrier ("the boot valve").
[0020] The septum and the boot valve are designed to minimize fluid
leakage from the patient side of the valve at high pressure (e.g.
when the IV tubing is kinked or clogged) and to prevent microbial
ingress from the outside environment into the patient's
bloodstream. The septum and the boot valve are joined at the
H-guide. The valve also includes a hollow spike having an open tip.
The spike preferably has a bullet-nose bridge structure with at
least two fluid opening channels or an unobstructed opening. The
boot valve completely covers the spike giving the valve the first
barrier of defense against fluid leakage to the outside environment
and the second barrier of defense against microbial ingress from
the outside environment into the patient's bloodstream. The septum
provides the first barrier of defense against microbial ingress
from the outside environment into the patient's bloodstream, and
the second barrier of defense against fluid leakage to the outside
environment. There is no dead space between the septum and the boot
valve. There is also no dead space between the spike tip bridge and
the inner wall of the boot valve. According to one embodiment,
there is an internal ring seal protruding from the inner wall of
the boot valve positioned just below the spike tip opening that has
an interference fit with the spike shaft to prevent fluid blow-by
down the outer surface of the spike. There is preferably an
interference fit between the septum and the boot valve, as well as
an interference fit between the H-guide and the two resilient
barriers. The boot valve is sufficiently resilient to move the two
resilient barriers and the H-guide immediately back to the original
slightly compressed state upon the removal of a male luer connector
from the female luer. The septum is preferably provided with an
outer shoulder or flange, a tapered end facing the boot valve, a
matching contour mating surface for mating with the boot valve, and
a single continuous swabbable surface facing away from the boot
valve and exposing the septum surface to the outside. The boot
valve is preferably provided with a spring-like "helical" external
surface. The septum and the boot valve are preferably pre-punctured
with a knife blade having a width of approximately 0.056 inches
which is lubricated with a fluorosilicone liquid formulation. The
surface of the spike is preferably roughened and coated with a
fluorosilicone lubricant.
[0021] The medical valve of this invention has many features; no
single one is solely responsible for its improved microbial and
functional attributes. The system achieves a zero fluid
displacement and an improved microbial ingress barrier.
[0022] Additional objects and advantages of the invention will
become apparent to those skilled in the art upon reference to the
detailed description in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWING
[0023] FIG. 1 is an exploded perspective view of a first embodiment
of the invention;
[0024] FIG. 2 is a longitudinal cross-sectional view of the
assembled components of FIG. 1;
[0025] FIG. 3 is a perspective view of a first embodiment of a boot
valve according to the invention;
[0026] FIG. 4 is a broken longitudinal cross-sectional view of the
assembled components of FIG. 2 and a standard male luer syringe
positioned to activate the valve;
[0027] FIG. 5 is a view similar to FIG. 4 showing the valve
activated by the standard male luer syringe;
[0028] FIG. 6 is a view similar to FIG. 2 showing the assembled
components in conjunction with a multiple-access drug vial
adapter;
[0029] FIG. 7 is a longitudinal cross-sectional view of a
Y-injection port according to the invention;
[0030] FIG. 8 is a view similar to FIG. 2 illustrating an alternate
spike body;
[0031] FIG. 9 is an enlarged side elevational view of a septum
according to the invention;
[0032] FIG. 10 is a section taken along line 10-10 in FIG. 9;
[0033] FIG. 11 is an enlarged side elevational view of an H-guide
according to the invention;
[0034] FIG. 12 is a top view of the H-guide of FIG. 11;
[0035] FIG. 13 is a section taken along line 13-13 in FIG. 11.
[0036] FIG. 14 is a side elevational view of a second embodiment of
a boot valve according to the invention;
[0037] FIG. 15 is a section taken along line 15-15 in FIG. 14;
[0038] FIG. 16 is an enlarged side elevational view of a female
luer body according to the invention;
[0039] FIG. 17 is a section taken along line 17-17 in FIG. 16;
[0040] FIG. 18 is a side elevational view of a spike body according
to the invention;
[0041] FIG. 19 is a top plan view of the spike body of FIG. 18;
[0042] FIG. 20 is a bottom plan view of the spike body of FIG.
18;
[0043] FIG. 21 is an enlarged section taken along line 21-21 in
FIG. 18;
[0044] FIG. 22 is a view similar to FIG. 2 illustrating a single
piece combination septum and boot valve;
[0045] FIG. 23 is a longitudinal sectional view of a guide wire
adapter for use with the injection port system of the
invention;
[0046] FIG. 24 is a top plan view of the guide wire adapter of FIG.
23;
[0047] FIG. 25 is a longitudinal sectional view of the guide wire
adapter of FIG. 23 coupled to an injection port system of the
invention;
[0048] FIG. 26 is a longitudinal cross-sectional overlay of a spike
body and a boot according to another embodiment of the
invention;
[0049] FIG. 27 is a highly magnified view of the tip portion of the
boot of FIG. 26 showing radii, angles and dimensions;
[0050] FIG. 28 is a side view of the boot of FIG. 26;
[0051] FIG. 29 is a cross-sectional view of the boot of FIG. 26;
and
[0052] FIGS. 30A and 30B are views of the inside surface walls of
the boot at proximal and distal locations shown in FIG. 29.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0053] Turning now to FIGS. 1-3, a first embodiment of a
needle-free intravenous injection port assembly 100 according to
the invention generally includes a spike body 102 provided with a
hollow spike 104, a female luer connector component 106, a flexible
and resilient boot valve 108, an H-guide centering member 110, and
a resilient septum 112. As seen best in FIG.2, the boot valve 108
extends over the spike 104, the H-guide 110 is provided over a
portion of the boot valve 108, and the septum 112 is provided
between the H-guide 110 and an end of the female luer connector
component 106. The spike body 102 and the female luer connector 106
are preferably made from a hard plastic material such as
polycarbonate and are welded, glued, or otherwise mated together
during assembly of the assembly 100. The H-guide 110 is preferably
made from a semi-rigid plastic such as high density polyethylene.
The boot valve 108 and the septum 112 are preferably made from a
rubber-like material, such as synthetic polyisoprene or silicone
rubber, having an approximately 60-70 Shore A Durometer. The inside
surface of the boot valve 108 is preferably roughened by EDMing the
injection mold core pin. During assembly of the assembly 100, the
septum 112 and boot valve 108 are compressed slightly, as the
height of the female luer connector component 106 is slightly less
than the height of the boot valve/septum combination up to the
shoulder 112a of the septum 112. Thus, in an at-rest position, the
boot valve is slightly compressed (as is the septum).
[0054] According to the illustrated embodiment and as shown in
larger view in FIG.3, the boot valve 108 is preferably configured
with a helical external surface 108a and a radially enlarged
portion 108b. The septum 112 is preferably provided with a shoulder
112a, a tapered end 112b facing the boot valve, and a single
continuous swabbable surface 112c facing away from the boot valve
as described in more detail below with reference to FIGS. 9 and 10.
The septum and the boot valve are preferably pre-punctured with a
knife blade having a width of 0.056'' by aligning the septum and
the boot valve in the H-guide in a subassembly and puncturing the
septum and the boot valve in a pre-assembly manufacturing process
as described below. The H-guide 110 is preferably provided with a
tapered internal surface 110a, 100b at both ends and its outer
surface 110c is polished very smooth as described in more detail
below with reference to FIGS. 11-13. The surface of the spike 104
is preferably roughened and is coated with a fluorosilicone
lubricant. The roughened finish may be achieved by several methods
including, but not limited to, EDM, sandblasting, media blasting,
chemical etching, mechanical means, etc. The roughened finish helps
to "entrap" the lubricant. The radially enlarged portion 108b of
the boot valve 108 is preferably tapered to match the taper of the
H-guide 110. The boot valve 108 and the septum 112 are preferably
mated with mechanical interference,
[0055] Turning now to FIGS. 4 and 5, a needle-free syringe 10 has a
male luer tip 10a which is matable with the female luer 106 of the
invention. The male luer tip 10a is pressed against the swabbable
surface 112a of the septum 112 and pushed down in the direction of
the arrows shown in FIG. 4. As the male luer 10a is moved into the
female luer 106, the septum 112 and the boot valve 108 are moved
over the spike 104 as shown in FIG. 5. This opens a fluid path
between the interior of the luer 10a and the interior of the spike
104 due to holes in the top of the spike as discussed below with
reference to FIGS. 18-21.
[0056] FIG. 6 illustrates how the invention can be used with a
multiple access drug vial adapter 12. The drug vial adapter 12 has
a female luer 12a at one end and a hollow spike 12b at the other
end. The male luer 102 of the injection port system 100 engages the
female luer 12a of the drug vial adapter and the spike 12b of the
vial adapter pierces the septum of a drug vial (not shown).
[0057] FIG. 7 illustrates a Y-site 200 incorporating an injection
port according to the invention. The Y-site 200 has a Y-site base
202 which includes a spike 204 which is the same or similar to the
spike 104 described above. The remaining components are the same as
described above. Those skilled in the art will appreciate that the
Y-site is useful when incorporated into an intravenous extension or
administration set to allow injections via the same intravenous
line through the injection port.
[0058] FIG. 8 illustrates an alternate embodiment of an injection
port 300. The injection port 300 has a spike body 302 with a spike
304 which does not have a point. It has, instead, an open tip 304a.
The remainder of the components are the same as described above.
This embodiment allows for the passage of guide-wires and other
implements through the valve as described below with reference to
FIGS. 23-25.
[0059] FIGS. 9 and 10 illustrate enlarged views of the septum 112.
The septum 112 has an upper frustrum 112d and a lower frustrum 112b
of larger diameter defining a shoulder 112a. The upper end of the
upper frustrum 112d is a continuous convex surface 112c. The lower
frustrum 112b defines a concavity 112e which is dimensioned to fit
the tip of the boot valve with mechanical interference.
[0060] The upper resilient septum 112 provides the first line of
defense against pathogen ingress into the fluid pathway from
outside the injection port, and the second line of defense against
fluid leakage due to high back pressure from inside the injection
port. The septum is held in the "H-Guide" 110 as shown in FIG. 2
with a dimensional interference causing a circumferential
mechanical force to assist in resealing the pre-puncture (not
shown) in the center of the septum and boot valve during numerous
activations. The outer shoulder or flange 112a has a larger
diameter than the opening of the female luer component 106 and the
upper frustrum 112d preferably makes an interference fit with the
female luer opening as seen in FIG.2.
[0061] As previously mentioned, the septum and boot valve are
preferably pre-punctured prior to assembly of injection port with a
lubricated piercing device. The pre-puncturing process is performed
with the septum, H-guide, and boot valve sub-assembly and a
piercing device which moves through the two independent and
adjacent resilient barriers until the piercing device is totally
through the sub-assembly. The piercing device, preferably a 0.056
inch width stainless steel knife blade (but other appropriate
piercing devices would be acceptable), pre-punctures both the boot
valve and septum in a smooth, in-line, axis geometry. This new
smooth, in-line, axis geometry coupled with the fluorosilicone
lubricant has reduced the required activation force to
approximately 3.8 lbs, making it easier to use. This manufacturing
process modification eliminates the jagged cuts, tears, and coring
that was observed in the original process utilizing the internal
spike tip. The piercing device is lubricated preferably with a
fluorosilicone lubricant which assists in a smooth
pre-puncture-axis geometry. The fluorosilicone formulation also
minimizes the "cross-linking" of the silicone molecular structure
during gamma radiation sterilization. It is understood that other
FDA approved lubricants could be acceptable for this application.
In addition, in order to improve the "snap-back" characteristics of
this new injection port, and to minimize frictional abrasions
within the boot valve during the compression or activation phase
when the septum and boot valve move down over the internal spike
tip and shaft, an inert lubricant is molded within the boot valve
formulation. Synthetic polyisoprene and silicone are the preferable
materials in this injection port due to their inertness, abrasive
resistance, sealing and internal memory characteristics, and their
sterilization capability. It is understood that other inert
resilient materials could be used for this application.
[0062] Turning now to FIGS. 11-13, the H-guide centering member 110
includes a generally tubular outer portion 110c and an annular
inner portion defining a hole 110d. The outer portion 110c is sized
to stably axially slide within the central portion of the female
luer component 106 as shown in FIG. 2. The outer portion 110c and
inner portion together define first and second substantially
identical receiving areas 110a, 110b. These areas have an outer
tapered portion and an inner non-tapered smaller diameter portion.
This assists in mating with the boot valve and the septum. The
receiving areas 110a, 110b are preferably provided with annular
rings 110e, 110f which assist in sealing the interface between the
septum and the boot valve.
[0063] FIGS. 14 and 15 illustrate a second alternate embodiment of
a boot valve. The difference between this embodiment and those
described above is that undulations 208a are not helical but
consist of a plurality of non-tapering projections arranged along
the axis of the boot valve 208. Although this boot valve may not
perform as well as the boot valve 108 in terms of snap back and
activation force, it does retain the advantages of the frustrum
208b, the dimensions of the tip 208c, and the sealing ring 208d
which helps seal the space between the boot valve and the spike
shaft.
[0064] FIGS. 16 and 17 illustrate enlarged views of the female luer
component 106. The female luer connector component 106 is tubular
and includes a first open end 106a, a female luer second end 106b,
and a central portion 106c therebetween. The first end 106a
includes a flange 106d which is preferably provided with an annular
mating ridge 106e. The ridge defines an enlarged diameter relative
to the central portion 106c, and is provided on the flange 106d
directed away from the second end 106b. The mating ridge 106e is
sized and shaped to be received in the annular mating slot of the
spike body 102 (described below with reference to FIGS.19 and 21).
The second end 106b includes an opening having a reduced (relative
to the rest of the component 106) with a tapered portion 106f and a
non-tapered portion 106g. The tapered and non-tapered portions
provide a better sealing fit with the septum 112 as shown in FIG.
2. A luer lock thread 106h is preferably provided about the second
end 106b.
[0065] The internal wall 106j of the component 106 is preferably
smooth and slightly tapered up to a perpendicular wall 106k,
leading to an opening approximately 0.180 inch diameter which
preferably tapers to approximately a 0.164 inch diameter in the
second end 106b of the female luer body component. The internal
wall is preferably smooth to allow the H-guide component to axially
move without obstruction during the compression and snap-back
phases. It is understood, that a fluted internal wall structure
could also be acceptable.
[0066] FIGS. 18 through 21 illustrate the spike body 102 in greater
detail. The spike body includes a first end 102a having a male luer
connector 102b, the spike 104 preferably integrally formed with the
body 102 and coaxially directed opposite the male luer connector
102b, and a base 102c at the juncture of the male luer connector
102b and the spike 104. A fluid path 105 is provided through the
spike 104 and male luer connector 102b. The spike 104 has a tapered
shaft 107 leading to a bullet-nose arched tip 109 which defines a
second end of the spike body 102. The tip 109 includes a plurality
of slots (e.g., three slots) 104a which provide access into the
hollow 105 of the spike 104 from outside the spike. The shaft 107
includes a base portion 107a which has an enlarged stepped diameter
for holding the boot valve thereabout. The base 102c of the spike
body 102 also includes an annular groove 102d which receives the
mating ridge 106e of the female luer component 106. The base 102c
preferably also includes a plurality of internal threads 102e which
together with the male luer connector 102b function as a male luer
lock. In addition, the periphery of the base 102c includes a
plurality of molded longitudinal ridges 102f to facilitate
engagement of the periphery of the spike body by human fingers.
[0067] As mentioned above, a preferred embodiment of the integral
spike shaft and spike tip used in the present invention is
configured with a roughened finish external surface and a
fluorosilicone liquid lubricate used along the shaft and tip. The
roughened finished external surface creates a roughened surface
with approximately 0.001 to 0.002 inch depth areas allowing for a
circumfluent flow of the liquid lubricant along the spike shaft and
spike tip. The previously incorporated co-owned invention had a
very smooth external spike shaft surface with a Dow 360 silicone
lubricant. This smooth surface caused on occasion a "suction"
affect between the internal wall surface of the boot valve
component and the spike shaft. The roughened finish allows the
lubricant to flow into the 0.001-0.002 inch impressions on the
spike shaft, eliminating the "suction" effect seen in the prior
invention, and maintaining adequate lubrication between the
internal wall of the boot valve and spike shaft during numerous
compression and snap-back cycles of the valve. This surface
improvement also enhances the snap-back feature of the valve.
[0068] From the foregoing, it will be appreciated that the female
luer 106, the septum 112, the H-guide 110, the boot valve 108, and
the spike 104 interact as described below to obtain numerous
advantages. The septum 112, by being properly dimensioned and
entrapped within the female luer component when in the assembled
slightly compressed state passes a 30 psi backpressure test, thus
improving the prevention of fluid leakage from the injection port.
It also provides a primary seal surface to further prevent gross
particulate contamination from entering into the body of the
injection port, thus preventing pathogen ingress into the patient's
blood stream. Further, the interference fit between the septum and
the female luer increases the circumferential mechanical force to
improve the resealing of the pre-puncture in the center of the
septum in the assembled slightly compressed state. In addition, as
discussed below, these elements help assist in obtaining a zero
fluid displacement for the assembly.
[0069] The taper of the lower frustrum 112b assists in the assembly
of the septum in the H-guide 110. The lower frustrum 112b also has
a larger diameter than the matching inside wall diameter of the
H-guide causing a mechanical interference. This mechanical
interference frictionally holds the septum into the H-guide.
[0070] The interior cavity 112e of the septum has a matching
contour to the tip of the boot valve 108. The diameter of this
cavity is smaller than the tip of the boot valve, causing a
circumferential mechanical fit against the pre-puncture in the boot
valve. This new design eliminates any interstitial cavity chamber
or dead space between these two interfaces thus assisting in
achieving a "zero fluid displacement" when the valve is moved from
the assembled slightly compressed state to the compressed state and
vice versa. The interference fit between the septum and the tip of
the boot valve also improves the performance of the injection port
in the assembled slightly compressed state in the following ways.
There is improved resealing of the pre-puncture in the center of
the boot valve, improved prevention of pathogen ingress into the
patient's bloodstream through the pre-puncture in the boot valve,
and improved prevention of fluid leakage from the patient's side of
the injection port.
[0071] Another design modification that improves the overall
performance of this new injection port is the provision of a single
continuous swabbable surface on the proximal side of the septum. In
addition, all of the external surfaces of the septum that come in
contact with the H-Guide and the boot valve are smooth to assist in
the sealing characteristics between these component interfaces.
[0072] The new H-guide centering component assists in the new
design enhancements and improvements. The H-guide contains both the
upper resilient septum and the lower resilient boot valve. The
outer diameters of the septum and the boot valve are larger than
the inner wall diameters of the H-guide where they interface,
giving a frictional interference fit between all components. The
H-guide centering component is also shaped similar to the lead-in
tapers of the septum and the boot valve for ease of assembly. The
dimensional mechanical interference between the septum and the
H-guide applies a mechanical pressure against the pre-puncture axis
of the two independent and adjacent resilient barriers, thereby
improving microbial ingress prevention, improving fluid leakage
prevention, and assisting in eliminating the dead space between the
septum/boot valve and boot valve/spike tip interfaces to achieve
zero fluid displacement during the compression and snap-back cycle.
The H-guide also prevents the two resilient barriers from coming in
contact with the female luer inner wall, thereby eliminating any
frictional abrasion during the compression and snap-back cycle of
the resilient barriers rubbing against the inner wall of the female
luer body element, thereby, improving the snap-back capability of
the valve. The H-guide also keeps the septum and boot valve in-line
puncture axis geometry "centered" over the stationary spike tip and
shaft, preventing jagged cuts, tears, or coring of the two
resilient barriers. The outer diameter of the H-guide is slightly
smaller than the inside diameter of the female luer body, allowing
for a smooth axial movement of the valve during compression and
snap-back cycle. A preferred material for the H-guide is
high-density polyethylene due to its lubricity characteristics, but
other plastic materials could function in this application.
[0073] FIG. 22 illustrates another embodiment of an injection port
400 according to the invention. This embodiment differs from the
first embodiment in that the boot valve 408 and the septum 412 are
a single piece. All of the other components are the same as the
first embodiment.
[0074] FIGS. 23 and 24 illustrate a guide wire adapter for use with
an injection port according to the invention. The guide wire
adapter 500 includes a male luer base 502 and an elongated female
luer body 504 coupled to the male luer base with a thin silicone
resilient disk 506 therebetween. The disk is preferably
pre-punctured in its center. The silicone disk prevents air ingress
into the patient's blood stream and prevents blood egress from the
device during guide-wire applications. The female luer body 504 has
a tapered inner bore 508 which is coaxial with the bore of the male
luer 502. The exterior of the female luer body 504 is fluted as
shown in FIG. 24. When the guide wire adapter 500 is coupled to an
injection port 300 of FIG. 8 as shown in FIG. 25, a guide wire 20
may be inserted through the adapter into and through the injection
port.
[0075] Turning now to FIG. 26, another embodiment of the boot and
spike of the invention is seen. In FIG. 26, the boot 608 and spike
604 are shown in their preassembled state as an overlay of each
other. Thus, at the area designated A, the base 608e of the boot is
shown extending down below (interfering with) the top surface 602f
of the lower luer portion of the spike, whereas, in reality, when
assembled, the base 608e of boot 608 must rest atop the surface
602f with the inner surface of the boot frictionally fitting on the
widened base 607 of the spike (see, e.g., FIG. 2). Similarly, at
the area designated B, the tip 609 of spike 604 interferes with the
tip 608c of boot 608. This is best appreciated by understanding
that the outer line marked "a" is the outer surface of the boot
608; the next line inward from line a is marked "b" and is the top
of tip 609 of the spike; and the next line marked "c" is the
interior surface of the tip 608c of boot 608. When assembled, the
spike tip will be within the boot (see, e.g., FIG. 2) and there
will be no gap between the spike tip and the boot tip. A third area
of interference seen is at the area designated C. However, when the
boot 608 is placed on the top surface 602f of the lower luer
portion of the spike, that interference disappears. In fact, a
small clearance is provided between the spike and the boot along
the length of the spike between the base 607 of the spike and the
sealing ring 608d in the tip area 609. This clearance permits the
boot to be relatively easily compressed without much friction when
the tip 608c of the boot 608 is forced over the spike tip during
use.
[0076] Turning now to FIGS. 27-30A and 30B in conjunction with FIG.
26, it will be appreciated that boot 608 is a helically threaded
boot as in the other embodiments of the invention. However, boot
608 differs from the other helically threaded boots in three
manners. First, as seen best in FIGS. 28 and 29, the outer surface
608a of the threaded portion of the boot 608 does not taper at all.
In fact, any horizontal cross-section through the threaded portion
of the boot 608 will show that the distance from one side of the
boot to the other is constant. Second, as seen best in FIGS. 30A
and 30B, the inside surface of the threaded portion of the boot is
configured as an octagon (although other polygons such as a
hexagon, pentagon, square, etc. could be utilized) such that there
is effectively no diameter to the inside and such that the points
of contact during compression of the boot over the spike are
reduced. It is noted that the tip portion of the boot maintains its
circular inside surface. Third, as seen best in FIGS. 26 and 29,
the wall thickness of the boot generally increases as the boot goes
from its base toward its tip. Thus, just above its base, the
octagonal area bounded by the inside surface of the boot (FIG. 30B)
is larger than the octagonal area bounded adjacent the tip (FIG.
30A). It has been found that the boot 608 provides less resistance
to the mating connection of a syringe luer to the injection port
valve system of the invention (i.e., a lower activation force by
approximately 50% relative to the boot of previously incorporated
U.S. Pat. No. 6,113,068), and provides better snap-back action.
[0077] Another difference between the embodiment of FIG. 26 and
other embodiments is that the spike 604 does not taper much towards
its tip end, and then has a middle section which flares outwardly.
This arrangement permits the assembly to be used with mini-volume
extension sets (used with IV syringe pumps). Other aspects of the
boot 608 and spike 604 are the same as in the other embodiments.
For example, the boot and spike are made of the same materials as
disclosed with reference to the other embodiments, the surface of
the spike 604 is preferably roughened and is coated with a
fluorosilicone lubricant, etc. With the spike and boot of FIG. 26,
a zero fluid displacement system is obtained with a connection
displacement of 0.000 mL-0.000 and +0.002 mL and a detachment
displacement of 0.000 mL.+-.0.000 mL
[0078] There have been described and illustrated herein several
embodiments of medical intravenous administration injection ports.
While particular embodiments of the invention have been described,
it is not intended that the invention be limited thereto, as it is
intended that the invention be as broad in scope as the art will
allow. Thus, it will be appreciated by those skilled in the art
that the term "intravenous fluid" is intended to be understood in a
broad sense to include parenteral fluids including drug solutions,
blood, blood products, dyes, or other fluids and the term
"administration" is used in its broad sense to include the
dispensing or collection of the "intravenous fluid". Further, while
the injection port is illustrated as preferably having a female
luer lock on one end, and a male luer lock on the other end, it
will be appreciated that, although not preferred, simple luer slips
could be utilized in lieu of luer locks. Furthermore, while a ridge
and groove are disclosed for mating the female luer component and
spike body together, it will be appreciated that other mating means
may be used. For example, a plurality of mating tabs and slots, or
ridges and grooves, or the like, may be used. Moreover, while a
particular plastic material has been disclosed for the spike body,
female luer component, and centering member, it will be appreciated
that other rigid materials may likewise be used for these
components. Also, in each embodiment the spike may be unitary with
or of a separate construction than the body. Furthermore, while
particular rubber-like materials have been disclosed for the boot
valve and septum, it will be appreciated that other rubber-like
materials of different Durometers may also be used. Further yet,
while the boot valve and septum are described as preferably being
pre-punctured with a knife blade, it will be appreciated that, if
desired, neither the boot valve nor the septum need be
pre-punctured, or only one of them might be pre-punctured, and that
they may be pre-punctured with a solid core needle or other means.
Alternatively, although not preferred, the boot valve and/or septum
may be pre-slit; i.e., injection molded with a horizontal slit
therein. Pre-slitting the boot valve and/or septum is not preferred
as during use the pre-slit boot and/or septum will not accommodate
the spike as well as a pre-punctured boot and/or septum. It will
therefore be more prone to tearing, thereby leaving the pre-slit
device more prone to undesirable microbial migration. Also, while a
boot valve having an outer helical surface and a linear and tapered
inner surface has been shown, it will be appreciated that the boot
valve could also have a helical inner or other non-linear or
non-tapered surface. Therefore, it will be appreciated by those
skilled in the art that yet other modifications could be made to
the provided invention without deviating from its spirit and scope
as so claimed.
* * * * *