U.S. patent application number 09/956608 was filed with the patent office on 2002-01-24 for medical connector.
Invention is credited to Laul, Virgil R., Lopez, George A..
Application Number | 20020010437 09/956608 |
Document ID | / |
Family ID | 46250609 |
Filed Date | 2002-01-24 |
United States Patent
Application |
20020010437 |
Kind Code |
A1 |
Lopez, George A. ; et
al. |
January 24, 2002 |
Medical connector
Abstract
Disclosed is a connector for introducing medication into a
patient in a safe, convenient way. It comprises a pair of plastic
tubular members adapted to be manually pushed together to engage in
a male-female relationship, and a locking mechanism that detachably
secures the members together. The male member has a sealed entry
port at its end, and the female member safely houses within it a
needle which centrally pierces the seal of the port upon engagement
of the members. Preferably, the locking mechanism provides a
"click" sound when it locks the members together.
Inventors: |
Lopez, George A.;
(Huntington Beach, CA) ; Laul, Virgil R.; (Dana
Point, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
620 NEWPORT CENTER DRIVE
SIXTEENTH FLOOR
NEWPORT BEACH
CA
92660
US
|
Family ID: |
46250609 |
Appl. No.: |
09/956608 |
Filed: |
September 18, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09956608 |
Sep 18, 2001 |
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09407147 |
Sep 28, 1999 |
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6290688 |
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09407147 |
Sep 28, 1999 |
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08944851 |
Oct 6, 1997 |
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5971950 |
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08944851 |
Oct 6, 1997 |
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08472787 |
Jun 7, 1995 |
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5688254 |
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08472787 |
Jun 7, 1995 |
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08424237 |
Apr 19, 1995 |
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08424237 |
Apr 19, 1995 |
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08279247 |
Jul 21, 1994 |
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08279247 |
Jul 21, 1994 |
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08020098 |
Feb 19, 1993 |
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5344414 |
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08020098 |
Feb 19, 1993 |
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07346193 |
Jan 9, 1987 |
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07346193 |
Jan 9, 1987 |
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06606679 |
May 3, 1984 |
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06606679 |
May 3, 1984 |
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06543248 |
Oct 19, 1983 |
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06543248 |
Oct 19, 1983 |
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06460585 |
Jan 24, 1983 |
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Current U.S.
Class: |
604/256 ;
604/905 |
Current CPC
Class: |
A61M 39/1011 20130101;
A61M 39/14 20130101; A61M 2205/195 20130101; Y10S 604/905 20130101;
A61M 2039/1027 20130101; A61M 2039/1033 20130101; A61M 2205/197
20130101; A61M 2039/1072 20130101 |
Class at
Publication: |
604/256 ;
604/905 |
International
Class: |
A61M 005/00; A61M
005/14 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 23, 1984 |
JP |
8669/84 |
Jan 19, 1984 |
EP |
84100 561.4 |
Claims
We claim:
1. A safety connector system which permits the transfer of fluid
from a first conduit to a second conduit, said first conduit having
a hollow tube at an end thereof, said second conduit having a
resilient, resealable septum at an end thereof, comprising: a
generally flat outer surface at the end of said second conduit;
said septum adapted to allow said hollow tube to penetrate said
septum and adapted to reseal when said tube is removed from said
septum; a locking mechanism for locking said first conduit to said
second conduit; said first conduit and said second conduit capable
of transferring a fluid between said first conduit and said second
conduit when said first conduit is locked to said second conduit;
and said first conduit and said second conduit capable of being
disengaged after said first conduit is locked to said second
conduit.
2. The connector system of claim 1, wherein said first conduit and
said second conduit are capable of penetrating, locking,
transferring fluid, and disengaging at least two times.
3. The connector system of claim 1, wherein said locking mechanism
comprises complementary threads on said first conduit and second
conduit for engaging said first conduit to said second conduit.
4. The connector system of claim 1, wherein said locking mechanism
comprises at least one lever arm for engaging said first conduit to
said second conduit.
5. The connector system of claim 1, wherein said locking mechanism
is capable of locking said first conduit to said second conduit
without relative rotation of said first conduit with respect to
said second conduit.
6. The connector system of claim 1, wherein said locking mechanism
comprises a pin on said first conduit for insertion into a slot in
said second conduit.
7. The connector system of claim 1, wherein said hollow tube is
disposed within a guard housing which substantially surrounds said
hollow tube.
8. The connector system of claim 7, wherein said end of said second
conduit is capable of being guided inside said guard housing of
said first conduit such that said hollow tube penetrates said
septum.
9. A safety connector system for safely administering medication
intravenously to a patient comprising: a cap member having a cavity
therein; a port element having a first end and a second end, said
first end having a seal extending thereacross and presenting a
generally flat outer surface for insertion into said cap member; a
piercing element contained in said cavity for penetrating said
generally flat outer surface of said seal; a first locking element
on said cap member for engaging a second locking element on said
port element for removably securing said port element to said cap
member; and said seal capable of resealing said first end of said
port element when said piercing element in removed from said
seal.
10. The safety connector system of claim 9, wherein said second
locking element on said port element comprises a lip for locking
said first locking element of said cap member with respect to said
lip.
11. The safety connector system of claim 10, wherein said port
element and said cap member are adapted to be removabley secured to
each other without relative rotation of said cap member with
respect to said port element.
12. The safety connector system of claim 9, wherein said cap member
is capable of being engaged to said port element by rotating said
cap member with respect to said port element.
13. The safety connector system of claim 12, wherein said cap
member further comprises a J-type slot having an entryway and a
base.
14. The safety connector system of claim 13, wherein said second
locking element of said port element comprises a pin for engaging
said entryway of said J-type slot and sliding along said slot until
said pin reaches said base.
15. A safety connector system for administering medication
intravenously to a patient, comprising: a port element having a
first end and a second end, said port element having a seal located
at the first end and having a generally flat outer surface, said
second end being in fluid communication with the patient; a cap
member having a locking element thereon for locking and engaging
with said port element; said first end of said port element adapted
to be inserted into a cavity of said cap member; said seal of said
first end of said port element adapted to be penetrated by said cap
member such that said first end of said port element is placed in
fluid communication with said cap member; said locking element
adapted to detachably lock said cap member and said port element by
engaging said locking element on said cap member such that said
first end of said port element is secured within said cavity of
said cap member; and said first end of said port adapted to seal
with said seal upon disengagement of said cap member and said port
element.
16. The safety connector system of claim 15, wherein said port
element comprises a lip for locking said locking element of said
cap member with respect to said lip.
17. The safety connector system of claim 15, wherein said locking
element is capable of detachably locking said cap member to said
port element without relative rotation of said cap member with
respect to said port element.
18. The safety connector system of claim 15, wherein said locking
element is adapted to detachably lock said cap to said port element
by rotating said cap member with respect to said port element.
19. The safety connector system of claim 18, wherein said locking
element of said cap member comprises a J-type slot having an
entryway and a base.
20. The safety connector system of claim 19, wherein said port
element comprises a pin for engaging said entryway of said J-type
slot and sliding along said slot until said pin reaches said base.
Description
RELATED PATENT APPLICATIONS
[0001] This application is a continuation-in-part application of
U.S. patent application Ser. No. 06/543,248, filed Oct. 19, 1983,
and entitled "Medical Connector System," which was a
continuation-in-part application of U.S. patent application Ser.
No. 06/460,585, filed Jan. 24, 1983, and entitled "Device for
Intravenously Introducing Medication Into a Patient," (now
abandoned). These previously filed patent applications, which are
incorporated herein by reference and made part of this patent
application, disclose the experimental versions of this invention.
These experimental versions are also disclosed herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to medical connectors used in the
treatment of the injured or sick, and in particular to a connector
for introducing medication into a patient in a safe, convenient
way.
[0004] 2. Background Discussion
[0005] It is a common practice in treating patients, particularly
patients who must be cared for under emergency conditions, with
medication introduced into the patient intravenously. An
intravenous solution, commonly referred to as parenteral liquid, is
fed from a container holding this liquid. The liquid flows through
tubing into a needle which has been inserted into the patient's
vein. The needle is taped securely to the patient's body and is not
likely to pull loose if the patient moves. Medication needed to
sustain the life of the patient, for example, drugs which maintain
the blood pressure of the patient at the desired level, are added
to the parenteral liquid. The conventional practice is to introduce
the medication through a second needle inserted into a sealed entry
port in the tubing through which the parenteral liquid flows.
[0006] One problem with this conventional practice is that the
needle may be pulled loose from the sealed port relatively easily.
Such accidental removal of the needle from the sealed port can have
very serious consequences and could even lead to the death of the
patient. Although many hospitals require nurses to tape the needle
securely to the tubing, this is not always done, because taping is
a burdensome and time consuming task.
[0007] A second problem with the conventional practice is needle
sticks. From time to time a nurse in attempting to insert the
needle into the sealed entry port will accidentally stick himself
or herself with the needle. This often occurs under emergency
conditions when the nurse is under pressure to complete this task
as quickly as possible. Not only is the accomplishment of the task
delayed, but the nurse must stop working and have a blood test
performed. Such a test is needed in case the nurse becomes
infected, because the hospital will be responsible financially.
Consequently, needle sticks not only result in increased hospital
cost, but are a possible life treating event to the nurse.
[0008] A third problem with the conventional practice is injection.
All too often a patient's life is seriously endangered by bacteria
gaining entry into a patient's blood stream and infecting the
patient. In a vast number of cases it is unknown how the bacteria
gain entry. We have observed conditions in hospitals and identified
that one likely way the bacteria gain entry is by contamination of
the needle inserted into the sealed entry port. This happens when
the nurse notices that the needle has been pulled loose and simply
reinserts it even though it may now have on its surface bacteria
picked up by direct contact with, for example, the patient's
bedding. Another possible way that bacteria may gain entry into the
patient's blood stream is through contamination of the tape used to
hold the needle to the connector.
MAJOR FEATURES OF THE INVENTION
[0009] The problems discussed above present a serious health hazard
to patients and their nurses. The present invention eliminates
these problems and provides a medical connector which is both safe
and convenient to use.
[0010] There are several features of this invention which
contribute to its safety and convenience, no single one of which is
solely responsible for these desirable attributes. Many of these
features were present in our experimental versions of the
invention, which were improved after testing. Without limiting the
scope of this invention as expressed by the claims, its more
prominent features will now be discussed briefly. After considering
this discussion, and particularly after reading the section of this
application entitled DETAILED DESCRIPTION OF THE DRAWING, one will
understand how the features of this invention provide the
attributes of safey and convenience.
[0011] One safety feature of this invention is the use of a cap
member to enclose the needle to be inserted into the sealed entry
port structure. This cap member fits snugly over the entry port
structure, connecting with the port structure in a male-female
mating relationship. The needle pierces the seal when the cap
member is seated on the port structure. This needle is housed deep
within a cavity in the cap member that terminates in an open mouth
into which the sealed end of the port structure fits. This open
mouth is narrow in width so that the finger of the nurse or patient
cannot fit into the cavity and contact the needle. Since the needle
is so mounted within the cap member, the likelihood of bacterial
contamination is avoided or reduced and the nurse is protected
against accidental needle sticks.
[0012] A second safety feature is provided by the wall design of
the cap member and port structure. These walls are of preferably
cylindrical configuration and engage each other like a telescope.
The interior surface of the wall of the cap member slides over the
exterior surface of the wall of the mating port structure, with
these walls engaging each other to guide the needle into the center
of the seal. This ensures that the needle does not scrape against
the inside surface of the wall of the port structure. Particles
scraped from this wall could make their way into the patient's
blood stream and result in death. This potentially lethal condition
is inherent in the design of conventional devices. But the
connector of this invention, with the guideway wall design of the
cap member and port structure, ensures that the needle is directed
into the center of the seal so that it avoids scraping against the
inside surface of the wall of the port structure. This guideway
wall design also permits the nurse quickly to connect the cap
member to the port structure. This makes the connector of this
invention not only more convenient to use, but in emergencies,
enables the nurse to administer medication to a patient faster than
with conventional devices and doing it without the danger of needle
sticks.
[0013] A third safety feature of the invention is that a locking
mechanism detachably secures the cap member to the port structure.
Because of this feature, movement of the patient does not result in
accidental removal of the needle from the seal. Although many
different types of locking mechanisms may be employed, the
preferred one provides a sound upon locking engagement of the cap
member and port structure. We have devised such a locking mechanism
which produces a sound such as a "click." This "click" is an
audible signal which tells the nurse that the cap member is locked
safely to the port structure and cannot be accidentally jarred
loose by movement of the patient.
[0014] Several embodiments of the invention illustrating all the
features of this invention will now be discussed in detail. These
embodiments show the invention-being used for administering
medication intravenously to a patient. This invention may also be
used to administer medication to a patient in other ways, for
example, intracranially or intraperitonially.
BRIEF DESCRIPTION OF THE DRAWING
[0015] The drawing, wherein like numerals indicate like parts,
depicts four embodiments of this invention in which:
[0016] FIG. 1 is a schematic view illustrating administering
medication intravenously to a patient in accordance with
conventional practice.
[0017] FIG. 2 is a cross-sectional view of a piggyback connector
for introducing parenteral liquid and medication intravenously to
the patient shown in FIG. 1.
[0018] FIG. 3 is a perspective view of the first embodiment of the
Medical connector of the present invention which employs a
slip-on/twist lock type means for securing the cap member to the
port structure.
[0019] FIG. 4 is a cross-sectional view of the connector shown in
FIG. 3 taken along line 4-4 of FIG. 3.
[0020] FIG. 4a is a perspective view showing how the cap member
prevents needle sticks.
[0021] FIG. 5 is a perspective view of the second embodiment of the
medical connector of the the present invention which employs a
snap-on type means for securing the cap member to the port
structure.
[0022] FIG. 6 is a cross-sectional view of the connector shown in
FIG. 5 taken along line 6-6 of FIG. 5.
[0023] FIG. 7 is an exploded perspective view of the third
embodiment of the medical connector of the present invention which
employs a snap-on type means for securing the cap member to the
port structure.
[0024] FIG. 8 is a side elevational view, with sections broken
away, of the embodiment shown in FIG. 7. In this FIG. 8 the handle
of the locking mechanism attached to the cap member just engages
the lip of the port structure.
[0025] FIG. 9 is the same view as shown in FIG. 8, except the
handle of the locking mechanism is flexed and just about to snap
into locking engagement with the lip of the port structure.
[0026] FIG. 10 is the same view as shown in FIGS. 8 and 9, except
the handle of the locking mechanism is now engaging the lip of the
port structure in the locking position.
[0027] FIG. 10a is the same view as shown in FIGS. 8, 9 and 10,
except the handle of the locking mechanism is flexed to permit
removal of the cap member from the port structure.
[0028] FIG. 11 is a top plan view of the cap member.
[0029] FIG. 12 is a bottom view of the handle of the locking
mechanism shown in FIGS. 8 through 11.
[0030] FIG. 13 is a side elevational view of the handle of the
locking mechanism.
[0031] FIG. 14 is a side elevational view of the cap member with
the handle of the locking mechanism removed.
[0032] FIG. 15 is a top plan view of the cap member with the handle
of the locking mechanism removed.
[0033] FIG. 16 is an enlarged cross-sectional view of a portion of
the hinge of the locking mechanism.
[0034] FIG. 17 is an enlarged cross-sectional view of the position
of the handle just prior to being secured to the cap member.
[0035] FIG. 18 is a cross-sectional view similar to that shown in
FIG. 17 depicting the handle coupled to the cap member.
[0036] FIG. 19 is a cross-sectional view taken along line 19-19 of
FIG. 18.
[0037] FIG. 20 is a perspective view showing the medical connector
of FIG. 7 having one end coupled to a tube extending from a
patient's arm and another end coupled to a tube extending from a
container holding medication.
[0038] FIG. 21 is a perspective view of a medical connector like
that shown in FIG. 7, except the port structure has the lip which
engages the handle of the locking mechanism as an integral part of
a conventional piggyback connector.
[0039] FIG. 22 is a schematic view showing a medical connector of
the type shown in FIG. 7 designed to introduce medication into a
patient's chest.
[0040] FIG. 23 is a perspective view of a fourth embodiment of the
medical connector of this invention which employs a slip-on/twist
lock type means for securing the cap member to the port
structure.
[0041] FIG. 24 is an enlarged cross-sectional view taken along line
24-24 of FIG. 23, showing the cap member being connected to the
sealed entry port structure.
DETAILED DESCRIPTION OF THE DRAWING
[0042] Conventional Connector System
[0043] As shown in FIGS. 1 and 2, the current way of intravenously
introducing parenteral liquid into a patient is by the conventional
feeding system 10. This feeding system 10 includes a container 12
for the parenteral liquid, a tube 14 extending from the container
and connected to a Y or "piggyback" connector 16, and a tube 18
from the piggyback connector to a needle (not shown) inserted into
a vein of the patient. The needle is taped to the patient so that
movement of the patient will not result in the needle being pulled
from the patient's vein.
[0044] As best illustrated in FIG. 2, medication from the container
20 is introduced through the piggyback connector 16 into the
parenteral liquid flowing through the feeding system 10. This
piggyback connector 16 consists of two tubular conduits 22 and 24
which merge into a third tubular conduit 26. The tubing 14 from the
container 12 of parenteral liquid is inserted into the inlet port
28 of the conduit 22 and secured in position, for example, by an
adhesive which bonds the external surface of this tube to the
internal wall surface of the conduit. There is a stop 30 which
limits the extent to which this tube 14 can be inserted into the
conduit. In a similar fashion, the tube 18 is secured to the outlet
port 32 of the piggyback connector. This tube 18 is inserted into
the outlet port 32 until it abuts a stop 34 in the internal wall of
the conduit. This tube 18 is secured by an adhesive to the internal
wall of the conduit 26.
[0045] The sealed entry port structure of the conventional feeding
system 10 is provided by the branch conduit 24 which has a standard
latex rubber seal 36 at its inlet port 38 to seal this port.
Consequently, bacteria cannot enter the piggyback connector 16 via
the inlet port 38 because of the seal 36. This seal 36 is of
conventional design and includes coaxial annular aprons 40 and 42
which fit over the conduit wall 24a and grip the external and
internal wall surfaces to hold the seal securely to the conduit 24.
A suitable seal may be obtained from the West Company of
Phoenixville, Pa.
[0046] The medication is introduced into the parenteral liquid
flowing through the piggyback connector 16 by a needle 44 which is
inserted through the central part of the seal 36 into the branch
conduit 24. This needle 44 is connected by a suitable connector 46
to a tube 48 which is connected to the container 20 (FIG. 1) for
the medication. As parenteral liquid flows through the piggyback
connector 16 into the inlet port 28 and out the outlet port 32, the
medication is drawn into this stream of liquid, flowing from the
container 20 via the tube 48 and through the open tip or end 44a of
the needle 44 into the parenteral liquid.
[0047] After studying FIGS. 1 and 2, the several problems
associated with the conventional practice can now be more fully
understood. If the patient moves, for example, rolls or moves his
or her arm, the needle 44 may be pulled from the seal 36. If this
occurs, the latex seal 36 has sufficient resiliency to close off
the hole in the seal produced by the needle 44. The parenteral
liquid will continue to flow into the patient's system, but the
necessary medication is no longer being introduced into it. The
consequences of this condition are very grave and, if this
condition is unnoticed by the nurse, it could result in the death
of the patient or serious complications in the patient's treatment.
Even if the nurse notices that the needle 44 has been removed from
the seal 36 and reinserts it into the seal, it is possible that the
needle has been contaminated with bacteria. The use of such a
contaminated needle 44 is unacceptable, but nevertheless this
sometimes happens. The needle 44 may be taped to the conduit 24,
and many hospitals instruct nurses to do this. When this task is
done, the needle 44 is secured, but cannot be conveniently removed
and then reinserted. And even when taping the needle 44, if this is
not done carefully, the needle may still be contaminated by the
nurse touching the needle or the tape being contaminated. Also,
because the nurse holds the conduit 24 with one hand while
inserting the needle 44, the nurse may accidentally stick the
needle directly into the hand holding this conduit, or stick the
needle through the conduit wall 24a into this hand.
[0048] These problems associated with the conventional practice are
eliminated by the several different embodiments of this invention
disclosed hereinafter.
[0049] First Embodiment of the Invention
[0050] As illustrated in FIGS. 3 and 4, the first embodiment of
this invention, connector 49, employs a cap member 50 housing deep
within the needle 44. As will be discussed in greater detail
hereinafter, the cap member 50 is secured by a slip-on/twist lock
type of locking mechanism to the piggyback connector 16 so that
movement of the patient does not result in the needle 44 being
pulled from the seal 36. The parenteral liquid is introduced via
the conduit 24, and the conduit 22 carries the seal 36 that covers
the inlet port 28. In this embodiment, this sealed conduit 28
constitutes the entry port structure 27. The cap member 50, is
detachably secured to the entry port structure 27, with the needle
44 penetrating the semi center of the seal 36 when the cap member
50 mates with the port structure 27.
[0051] The cap member 50 comprises a cylindrical connector section
56 having a hollow interior forming the chamber or cavity 52
housing the needle 44. This needle 44 is disposed lengthwise along
the longitudinal axis of the cavity 52 and is centrally located.
The cavity 52 has an open mouth 52a which allows the cap member to
be seated over the port structure 27. The mouth 52a, however, is
constricted so that, as illustrated in FIG. 4a, it prevents the
little finger of a typical adult user from being inserted into the
cavity 52. The tip or end 44a of the needle is safely displaced
inwardly from the open mouth 52a so that even if the user
intentionally inserted his or her finger into the open mouth, the
tip of the needle would not stick this finger. Typically, the open
mouth 52a has a maximum width of no greater than about one
centimeter, and the minimum distance between the mouth 52a and the
tip 44a is about one centimeter.
[0052] The locking mechanism includes the threads 69a formed in the
end 54 of the interior cavity wall 55 and the threads 69b in the
exterior wall of the conduit 22. These threads 69a and 69b engage
upon connection of the cap member 50 to the port structure 27 by
screwing the cap member to the conduit 22. The top of the cap
remember 50 has a pair of outwardly extending wings 58 which
facilitate screwing the cap member 50 to the conduit 22. As this is
done, the interior wall 55, sliding over the exterior surface of
the conduit 22 guides the needle 44 so that it penetrates the
center of the seal 36. To further ensure that the needle 44
penetrates the center of the seal 36, the threads 69b could be
lowered further beneath the seal so that the cap member would fit
telescopically over the conduit 22 and then be screwed into
position. Thus, the cap member 50, serving as the female component,
and conduit 22, serving as the male component, mate in a
male-female relationship, with the needle 44 always being housed
safely within the center of the cavity in an unexposed condition
and positioned to pierce the center of the seal 36.
[0053] A spindle 59 is provided to enable the cap member 50 to be
screwed onto the port structure 27 without twisting the tube 48.
This spindle 59 is received within an opening 61 within the cap
member 50. The body of the spindle 59 has a cylindrical neck
section with a groove 63 in an end which protrudes from the opening
61. The cylindrical body expands outwardly slightly to provide a
shoulder 65 which engages a stop 66 when the spindle 59 is placed
in the opening, and a TRU seal C-ring 67 is received in the groove
63 to hold the spindle in position but allowing the cap member to
revolve about the spindle as it is screwed onto the port structure
27.
[0054] Along the longitudinal axis of the spindle 59 is a
passageway 60. The tube 48 from the container 20 holding the
medication is inserted into the one end 60a of the passageway 60
and is bonded to the internal surface of this passageway, for
example, by means of an adhesive. The other end 60b of the
passageway terminates in a threaded connector section 62 to which
the needle 44 is secured. This needle has an adapter 64 which has
an internal thread which engages the threads of the connector
section 62. The needle 44 extends outwardly from this adapter 64.
Thus, the needle 44 is held secure to the piggyback connector 16,
penetrating the center of the seal 56 with its point 44a safely
displaced away from the inside wall 55 of the conduit 22.
[0055] This connector 49 embodies many of the features of this
invention. For example, the cap member 50 safely houses the needle
44, and the threads on the guiding walls provide means for
detachably securing the cap member to the port structure without
taping. But it has several components, and therefore is costly to
manufacture, it is time consuming to screw the cap member 50 to the
port structure, and it does not provide an audible signal when the
cap member is safety secured to the port structure. This later
feature is provided by the second and third embodiments of this
invention.
[0056] Second Embodiment of the Invention
[0057] The second embodiment of the present invention, connector
71, is shown in FIGS. 5 and 6. In this embodiment a cap member 70,
similar to cap member 50, is simply snapped onto the piggyback
connector 16. The snap-on type locking mechanism of this connector
71 is easier to use and less costly to manufacture than the
slip-on/twist type of the first embodiment.
[0058] In this embodiment, the cap member 70 includes a hollow
cylindrical element 72 which carries on its exterior two clips 74
which have catch tips 76 that snap into a groove 78 in the external
wall of the conduit 22. The clips 74 are mounted by hinges 75 to
the element 72, and are integral with the element 72. A plug
assembly 80 carries the tubing 48 and the needle 44, which is
mounted on an adapter 64 such as shown in FIG. 4. This plug
assembly 80 is glued or otherwise bonded to the open end of the
cylindrical member 72. The cap member 70, including clips 74 and
hinges 75, are molded from the same material, for example, nylon,
which is a material having the desired resiliency.
[0059] To attach the cap member 70, one simply slips the member 70
over the conduit 22. The clips 74 bend outwardly slightly and, when
the catch tips 76 of the clips are opposite the groove 78, the
clips snap in place as shown in solid lines in FIG. 6. The
centrally mounted needle 44 is guided into the center of the seal
36 by the cap member 70, which, like a telescope, slides over the
tubular conduit 22. There is shoulder 82 which serves as a stop to
limit the movement of the cap member 70. This shoulder 82 brings
the catch tips 76 of the clips into registration with the groove
78. The hinges 75, being of the same material as the clips 74,
provide an internal bias or spring action due to the resiliency o
the material from which these clips and hinges are made.
Consequently, the clips 74 snap into a locking position, locking
the cap member to the conduit 22 when the catch tips 76 are in
registration with the groove 78. To release the cap member from the
piggyback connector 16, the clips 74 are simply depressed and the
cap member 70 is removed.
[0060] One of the features of the slip-on type locking mechanism is
that with one simple inwardly push the needle 44 is inserted
directly into the center of the seal 36 and the cap member is
locked to the port structure. Another feature of this connector 71
is that when the tips 76 of the clips snap into the groove 78 a
"click" sound is made by the tips striking the body of the cap
member. With repeated use, however, the hinges 75, due to internal
stress produced in the nylon material, loose some of their spring
action. Consequently, the tips 76 are not held with sufficient
force in the groove 78, nor do they strike the body of the cap
member to produce the desired "click" sound. Moreover, the material
will eventually crack along the flex line of the hinge and a break
will occur. The reliability of this connector 71 is substantially
improved by the third embodiment of this invention which employs a
unique locking mechanism.
[0061] Third Embodiment of the Invention
[0062] As shown in FIG. 7, the third embodiment of this invention,
connector 90, includes a sealed port structure 91 and a cap member
92 having a locking mechanism 94 for detachably securing the cap
member 92 to the port structure 91. The cap member 92 is similar to
the cap members of the other embodiments and houses within its
cavity 92a (FIG. 8) the needle 44. The cavity 92a has a tapered
side wall 93 to better direct the needle 44 into the center of the
seal 36.
[0063] The port structure 91 is a tubular conduit 102 having, at
one end, a reduced diameter nipple 104 over which the seal 36 fits
and, at the other end, a tapered barrel 103. The seal 36 is of the
same type employed in conventional devices such as shown in FIG. 2.
Material is removed from the barrel 103 to reduce cost. This
results in the formation of flutes 103a in the barrel 103. At the
base of the barrel 103, adjacent the end of the port structure 91,
is an annular, disk-like piece which provides a lip 106. When the
cap member 92 is placed over the port structure 91, a handle 96,
which is a component of the locking mechanism 94, engages this lip
106. The handle 96 is hinged to the body 98 of the cap member by a
two component hinge 100.
[0064] As best shown in FIGS. 14 and 15, a hook 114 is one
component of the hinge 100 and the other component of the hinge is
a crossrod 108 (FIG. 18) carried by the handle 96. The hook 114
projects outwardly from the body 98 of the cap member and has
adjacent to it a ramp 116, which as shown in FIG. 18, holds the
crossrod 108 when the handle 96 is attached to the body of the cap
member. A section of the crossrod 108 is cut away to provide a
miter slot 118 which engages the ramp 116.
[0065] The handle 96 is best shown in FIGS. 12 and 13. It has a
pair of spaced apart plates 110 and 112 extending downwardly from
the underside of the handle and the crossrod 108 is disposed
between these plates, with the opposed ends of the crossrod being
integral with the plates. Opposite the crossrod 108 and parallel to
it is a third plate 120, which is integral with the underside of
the handle 96 and is at a right angle to and connects with the
forward ends of the plates 110 and 112. Disposed on the underside
of the handle 96 between the catch tip 122 and the plate 120 is a
clapper bar 126. The clapper bar 126 produces the "click" sound
when it strikes the body 98 of the cap member. This clapper bar 126
extends away from the plate 120 at a right angle and is integral,
at one end of the handle, with the catch tip 122 and, at its
opposite end, with the plate 120. The leading edge 124 of the catch
tip 122 is beveled to facilitate the slippage of this tip up and
over the lip 106 which is also beveled. At the point where the
clapper bar 126 merges with the inside of the catch tip 122, there
is a notch 128, which, as shown in FIG. 10, receives the lip 106
when the handle 96 is in the locking position. At the rearend of
the handle 96 is a leaf spring 130 which has one end free and its
opposed end integral with the handle 96. At the free end of the
leaf spring 130 are two spaced apart tracks 132 and 134 (FIG. 12).
When the handle 96 is attached to the body of the cap member as
shown in FIGS. 8 through 10, a finger 136 on the body 98 of the cap
member is received within the channel 138 between the tracks 132
and 134. On the underside of the handle 96 are two downwardly
projecting reinforcing strips 140 and 142 (FIG. 12) which provide
structural rigidity to the handle.
[0066] The way in which the handle 96 is pivotably connected to the
cap member 92 by the two component hinge 100 is illustrated by
FIGS. 16 through 19. To attach this handle 96 to the body 98 of the
cap member, first one positions the handle over the body of the cap
member opposite the hook 114 and then moves the handle into contact
with the cap member so that the crossrod 108 touches the rearend of
the ramp 116. The spring 130 is depressed at this time. Next, the
handle 96 is moved towards the left, as shown in FIG. 17, with the
crossrod 108 sliding up the ramp 116 until it engages the leading
edge 140 of the hook 114. The dimension between the edge 142 of the
ramp 116 and the edge 140 of the hook 114 is less than the diameter
of the crossrod 108. Consequently, the hook 114 must flex slightly
upwardly in a counterclockwise direction, as viewed in FIG. 17,
until the crossrod 108 clears the edge 142 of the ramp and snaps
into the position shown in FIG. 18. The hook 114 thus returns to
the unflexed condition shown in FIG. 18, wrapping around the
crossrod 108. The miter slot 118 then engages the edge 142 of the
ramp, with this edge abutting the junction 118a of the slot 118
(FIG. 18). The ramp 116 thus holds the crossrod 108 in position,
preventing the handle from becoming dislodged from the hook 114 and
preventing the handle 96 from tilting to-and-fro about its
longitudinal axis. When the handle 96 is so mounted to the body 98
of the cap member, the finger 136 slips into the channel 138
between the tracks 132 and 134 and holds the rearend of the handle
so that it does not tend to move laterally. The handle 96 is,
however, free to pivot about the hinge 100.
[0067] Unlike the hinges 75 of the second embodiment of this
invention, the two component hinge 100 does not break due to
fatigue. Thus, in accordance with one feature of connector 90, the
handle 96 may be moved between a locked position (FIG. 10) and
unlocked position (FIG. 8) as often as one wishes without breaking.
At the same time, the handle 96, coating with the body 98 of the
cap member 92, generates a "click" sound when the cap member is
locked to the port structure 91. This "click" sound, as best
illustrated in FIGS. 9 and 10, occurs when the handle 96 moves
between the flexed position shown in FIG. 9 and the locked position
shown in FIG. 10.
[0068] The connector 90 is highly reliable under actual hospital
working conditions, and the way connector 90 is used is best shown
in FIGS. 8 through 10a. First, the nurse inserts the end of the
port structure carrying the seal 36 into the open mouth 93 of the
cap member 92 to bring the lip 106 into engagement with the catch
tip 122 of the handle 96 as shown in FIG. 8. As this is done, the
tapered side wall 93 of the cap member and the tapered barrel 103
slide along each other to direct the needle 44 into the center of
the seal 36. Simultaneously, the beveled edge 124 of the catch tip
rides over the beveled lip 106 until the lip just engages the
underside edge of this tip as shown in FIG. 9. This causes the
handle 96 to rotate in a clockwise direction as viewed in FIG. 9,
with the crossroad 108 turning while in the grasp of the hook 114.
There is enough clearance between the miter slot 118 and the edge
142 of the ramp to allow the crossrod to turn sufficiently so the
catch tip 122 clears the lip 106. Thus the handle 96 pivots about
the hinge 100, depressing the spring 130. With the handle 96 and
lip 106 in this position and the spring 130 depressed, as soon as
the lip 106 clears the edge of the catch tip 122, the spring
rotates the handle in a counterclockwise direction, moving it to
the position shown in FIG. 10 with ample force so that the clapper
bar 126 strikes the body 98 of the cap member to produce the
"click" sound. This "click" sound is the audible signal which the
nurse may rely upon to indicate that the cap member 96 is locked to
the port structure 91. Under certain hospital conditions,
particularly in the intensive care unit where there is not a great
deal of light, this is an important feature because it provides
additional assurance that the cap member 92 is locked to the port
structure 91.
[0069] As shown in FIG. 10, with the handle 96 in this locked
position, the needle 44 has penetrated the central portion of the
seal 36, directed by the tappered sidewalls of the cavity 92a and
the barrel 103. Medication now flows through the connector 90 into
the patient. Note, the handle 96 is not depressed as the cap member
92 is slid over the port structure 91. To remove the cap member 92,
the handle 96 is depressed, moving it to the position shown in FIG.
10a. With the handle 96 in this position, the cap member 92 is
pulled off the port structure 91.
[0070] Except for the seal 36, the connector 90 is made entirely of
a transparent plastic. The use of a transparent plastic is
preferred because this allows the nurse to see that the needle 44
is correctly inserted into the seal 36, and thus provides
additional safety. Also, the use of plastic makes the connector 90
a low cost, disposable item. The plastic most suitable is a
polycarbonate made by Cyrolite Industries in Azusa, Calif. sold
under the tradename Cyrolite. This plastic, which is commonly
employed to make medical devices, has been approved for such uses
by the United States Federal Drug Administration.
[0071] The connector 90 is particularly adapted to be used in a
variety of different applications. For example, as illustrated in
FIG. 20, it may be connected directly in line with a container 144
of medication to be supplied intravenously to a patient. In this
instance, the cap member 92 has a tube 146 extending from it which
has at its one end a male component 148 of a conventional luer lock
connector. This male component 148 engages and locks with a mating
female luer component 150 attached to the end of a line 146
extending from the container 144. In a similar manner, the port
structure 91 has extending from it a tube 154 which has at its end
a female luer component 158 of a second luer lock connector. The
male component 156 of this second luer lock connector is attached
to the end of a tube 160 that is connected to a needle inserted
into the vein of the patient. The luer lock connectors may be
obtained from Burron Medical, Inc. in Bethlehem, Pa.
[0072] FIG. 21 illustrates the connector 90 integrated into a
conventional piggyback connector 162. The branch line 164 from the
piggyback connector 162 has attached to it and integral therewith
the port structure 91 including the lip 106 that engages the catch
tip 122 of the locking mechanism 94. Thus, a conventional feeding
system 10 employing a piggyback connector may be modified by simply
including a lip 106 adjacent the seal 36. This lip 106 will then
serve as the site for detachably connecting the cap member 92 to
the piggyback connector 162.
[0073] The connector 90, as shown in FIG. 22, also lends itself to
be used with central venous catheters which are inserted into the
chest of the patient. Frequently, patients under home care use such
catheters, and consequently, even simpler and safer devices and
techniques must be employed. However, a serious problem with such
catheters is the way the ends of the lumens or tubes 166 and 168
extending from the patient are sealed. Presently, the ends of these
tubes 166 and 168 are sealed using conventional luer locks. When it
is time for the patient or the nurse to introduce medication into
the catheter, an intermediate portion of the tubes 166 and 168 must
be clamped while being connected to the source of medication so
that air is not drawn into the blood stream of the patient. Any
large intake of air into the patient's blood stream will seriously
injure or even kill the patient. With children, even a small amount
of air may be fatal. That is why clamps are used to close off the
tubes 166 and 168 until the connection is made with the source of
medication. This results in the tubes 166 and 168 wearing out,
requiring that they be repaired. Not only is this a dangerous
system, but it is extremely inconvenient for the patient or nurse
to use.
[0074] As illustrated in FIG. 22, the connector system 90 overcomes
these difficulties by simply having at each of the respective ends
of the tubes 166 and 168 port structures 91. When the patient needs
medication, he or she simply connects two of the cap members 92 to
the respective port structures 91, and when finished, disconnects
the cap members. The medication is fed by the needles 44 through
the seals 36 and into the respective tubes 166 and 168. The cap
members 92, when detached, withdraw the needles 44 from the seals
36, which are self sealing. Thus, the nurse does not need to clamp
off the tubes 166 and 168 nor is periodic repair of the tubes
required. Since the seal 36 is self-sealing, upon removal of the
cap member 92 there is no danger of air being drawn through the
port structure 91 into the patient's blood stream. Consequently,
connector 90 is both safer and more convenient to use than the
conventional central venous catheters.
[0075] The connector 90 is also adapted to be used repeatedly
without damaging the seal 36. Thus it is even more suitable for
such applications as illustrated in FIG. 22 than conventional
devices, because of the accuracy with which the needle 44 may be
repeatedly directed into the center of the seal 36. When the needle
44 is repeatedly stuck into and withdrawn from the seal 36, the
seal will have numerous holes in it and begin to develop a "swiss
cheese" like appearance. Eventually, a core is cut away from the
seal by several of these holes interconnecting, rendering the seal
useless because it is no longer self-sealing. Consequently, the
seal would have a very short life. By carefully controlling the
dimensions of the molds used to make connector 90, the cap member
92 and port structure 91 will be precision made parts.
Consequently, with repeated use, the needle 44 will essentially
always penetrate the same hole in the seal 36, thus avoiding the
"coring" problem.
[0076] Fourth Embodiment of the Invention
[0077] The fourth embodiment of this invention, the connector 170,
is illustrated by FIGS. 23 and 24. In connector 170 the port
structure 172 is similar to that shown in the other embodiments
except it has a pair of pins on opposite sides of its body 178
which co-act with J-type slits 180 and 182 in the sidewall of a cap
member 183 housing the needle 44. These J-type slits 180 and 182
are opposed to each other and provide a guideway for the pins 174
and 176 which slide along these slits as the port structure 172
matingly engages the cap member 183.
[0078] To use this connector system 170, the nurse aligns the port
structure 172 with the open mouth 183a of the cap member so that
the pins 174 and 176 are in alignment with the entryway to the
J-type slits 180 and 182. Then the nurse pushes the port structure
172 into the open mouth 183a, sliding the port structure into the
cavity within the cap member 183. The pins 174 and 176 first engage
the entryway of the J-type slits 180 and 182 and then slide along
the slits until they reach the base of the slits. At this point,
the nurse twists or rotates the cap member 183 and port structure
172 in counter-rotating directions so that the pins 174 and 176
will then slide respectively into the hooks 180a and 182a of the
slits and be secured. This embodiment does not provide an audible
signal upon locking the cap member 183 to the port structure 172,
but is very economical to-manufacture.
[0079] Function of the Cap Member and Port Structure
[0080] As will be appreciated from the above description, the cap
member provides several functions in a single structure. (We will
no longer refer by number to any one of the components of the
invention since we are now discussing in general how the cap member
and port structure function to provide the attributes of safety and
convenience.) First, the cap member surrounds the needle and
provides a housing in which the needle is lodged safely so that
needle sticks are avoided. Second, because the needle is so lodged
within the housing, if the nurse did, for example, lay the cap
member on the patient's bed, the needle would not come into direct
contact with the bedding which might be infested with harmful
bacteria. Thus, this arrangement of the needle deep within the
cavity in the cap member provides protection for the patient
against bacterial contamination and protection for the nurse
against accidental needle sticks.
[0081] The port structure also provides more than one function.
First, it serves as the site to attach the cap member, and, by
means of a simple locking element such as a lip, thread, groove,
pin or the like, provides an economical way to modify the
conventional piggyback connector so that it may be used with the
cap member. Second, the combination of a self-sealing seal and
adjacent element that locks with the cap member provides a simple
way to modify connectors so that they have enhanced safely and
convenience.
[0082] The cap member and port structure function in combination to
direct the needle into the center of the seal, lock these pieces
together, and enable quick connection. The nurse or patient simply
aligns the sealed end of the port structure with the open mouth of
the cap member and pushes the two pieces together. The internal
wall of the cap member and the exterior wall of the port structure
engage to align the two pieces so that their respective axes
coincide, guiding the needle into the center of the seal as they
are pushed together. Consequently, the needle does not scrape the
inside wall of the port structure so that particles of plastic are
not introduced into the patient's blood stream and the coring
problem is virtually eliminated. The cap member and port structure
each carry elements of a locking mechanism which engage and lock
the pieces together when the needle has pierced the seal,
preventing accidental disconnect. Although other geometric forms
may be employed, quick connection is facilitated by the cylindrical
configuration of the walls of the cap member and port structure and
the circular open mouth of the cavity. In particular, the first
through third embodiments of this invention are very quickly
connected because no extra step is required to align the cap member
and port structure. All that the nurse need do is insert the port
structure into the open mouth without any special concern for their
relative positions, and, when using the second and third
embodiments, simply push these two pieces together until the
locking mechanism engages. When using the first or fourth
embodiments, the extra step of rotating the two pieces relative to
each other is required to engage the locking mechanism. When using
the forth embodiment, the pins must also first be aligned with the
entryways to the J-slits prior to pushing the port structure into
the cavity in the cap member.
[0083] Because of the features embodied in the cap member and port
structure, this invention may be used under normal hospital
conditions without creating any additional work for the nurse,
while substantially reducing the likelihood of harm to the patient
due to carelessness and protecting the nurse against infection and
making his or her job easier and faster.
SUMMARY
[0084] In summary: Our connector is safe because (a) the needle is
recessed deeply within the cap member and, therefore, is not likely
to be contaminated by bacteria, (b) the cap member and port
structure upon engagement guide the needle into the center of the
seal, avoiding scraping particles from the inside wall of the port
structure, (c) the cap member, housing the needle safely within it,
protects the nurse against needle sticks, and (d) the locking of
the cap member and port structure together prevents accidental
disconnects and (e) the "click" signals the nurse when the
connector system is locked securely in position. Our connector is
convenient to use because (a) the walls of the cap member and port
structure, interacting with each other, provide a guideway for
quick connection, (b) the locking mechanism eliminates the
burdensome and time consuming task of taping, and (c) the connector
is very simple to use so that it is ideal for home care of
patients.
SCOPE OF THE INVENTION
[0085] The above description presents the best mode contemplated of
carrying out the present invention as depicted by the four
embodiments disclosed. The combination of features illustrated by
these embodiments provide the safety and convenience of this
invention. This invention is, however, susceptible to modifications
and alternate constructions from the embodiments shown in the
drawing and described above. Consequently, it is not the intention
to limit it to the particular embodiments disclosed. On the
contrary, the intention is to cover all modifications and alternate
constructions falling within the scope of the invention as
generally expressed by the following claims:
* * * * *