U.S. patent application number 10/650093 was filed with the patent office on 2004-10-14 for fastening mechanism for medical connectors.
This patent application is currently assigned to QD Enterprises, LLC. Invention is credited to Corn, Stephen B., Segal, Scott.
Application Number | 20040201216 10/650093 |
Document ID | / |
Family ID | 22245171 |
Filed Date | 2004-10-14 |
United States Patent
Application |
20040201216 |
Kind Code |
A1 |
Segal, Scott ; et
al. |
October 14, 2004 |
Fastening mechanism for medical connectors
Abstract
A medical connector adapted for placement between a catheter and
a medical infusion or injection source includes a pair of
interlocking half medical connector portions, one side of which
attaches to the infusion source and the other side of which is
coupled to the catheter connected to the patient and a locking
mechanism for locking a medical connector portion to a medical
fitting. The connection to the catheter and the infusion source can
be via standard medical luer taper fittings, with or without
specially designed locking mechanisms that prevent inadvertent
disconnection. The medical connector itself is uniquely shaped and
includes a raised surface feature and a recessed surface feature
formed on the medical connector portions.
Inventors: |
Segal, Scott; (Chestnut
Hill, MA) ; Corn, Stephen B.; (Sharon, MA) |
Correspondence
Address: |
LAHIVE & COCKFIELD, LLP.
28 STATE STREET
BOSTON
MA
02109
US
|
Assignee: |
QD Enterprises, LLC
Sharon
MA
|
Family ID: |
22245171 |
Appl. No.: |
10/650093 |
Filed: |
August 26, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10650093 |
Aug 26, 2003 |
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10124288 |
Apr 17, 2002 |
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6612624 |
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10124288 |
Apr 17, 2002 |
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09094433 |
Jun 8, 1998 |
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6402207 |
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Current U.S.
Class: |
285/401 |
Current CPC
Class: |
A61M 39/10 20130101;
A61M 2039/1072 20130101; A61M 2039/1094 20130101; Y10S 285/914
20130101; F16L 37/248 20130101; A61M 2039/1033 20130101; A61M
2205/6045 20130101 |
Class at
Publication: |
285/401 |
International
Class: |
F16L 021/00 |
Claims
Having described the invention, what is claimed as new and desired
to be secured by Letters Patent is:
1. A medical connector suitable for use in coupling a fluid
delivering conduit to a fluid receiving conduit for administering
fluid to a patient, said medical connector comprising: a first
medical connector housing part having a first end sized to mate
with a first medical fitting on one of said fluid receiving conduit
and said fluid delivering conduit and a second end having a
selected first surface feature formed thereon, second medical
connector housing part having a first end configured to mate with a
second medical fitting on one of said fluid receiving conduit and
said fluid delivering conduit, and a second end having a selected
second surface feature complementary in shape to the first surface
feature of the first housing part, so that when assembled the first
surface feature of the first housing part couples with the second
surface feature of the second housing part to form a fluid
connection therebetween, and a locking mechanism for locking
together one of said medical connector housing parts and said first
medical fitting, comprising a protrusion on the first end of the
first medical housing parts and screw threads on said first medical
fitting adapted to receive the protrusion, wherein said first
surface feature is sized and configured so as to only mate with the
complementary shaped second surface feature to prevent another
fluid delivering conduit associated with a differently configured
surface feature from being connected to the fluid receiving
conduit, thereby preventing the accidental administration of
another fluid to the patient through the first and second housing
parts.
2. The medical connector of claim 1, wherein the first medical
connector housing comprises: an inner body rigidly connected to the
protrusion and containing a central fluid lumen; and an outer
sleeve surrounding the inner body configured to rotate in a first
direction about the inner body.
3. The medical connector of claim 2, wherein the first medical
connector housing part further includes a ratchet mechanism to
prevent rotation of the outer sleeve in a second direction opposite
the first direction.
4. The medical connector of claim 3, wherein the ratchet mechanism
comprises teeth on an inner surface of the outer sleeve engaging a
pawl formed on an outer surface of the inner body.
5. The medical connector of claim 3, wherein the first medical
connector housing part is locked to the medical fitting by
inserting the protrusion into the threads and rotating the medical
connector in the second direction such that the protrusion engages
the threads, thereby screwing the first medical connector housing
part into the medical fitting.
6. The medical connector of claim 5, wherein rotation of the
medical connector in the first direction causes the outer sleeve to
rotate about the inner body while the protrusion is maintained in
an engaged position with the threads.
7. A method of administering fluid to a patient, comprising
providing a fluid receiving conduit connected to the patient and
having a first medical fitting coupled to the distal end of the
fluid receiving conduit, said first medical fitting including screw
threads; locking a first medical connector housing part to said
first medical fitting, wherein said first medical connector housing
part has a first end having a protrusion adapted to mate with the
screw threads of the first medical fitting, and a second end having
a selected first surface feature formed thereon, providing a fluid
delivering conduit associated with a fluid source and having a
second medical fitting coupled to the distal end of the fluid
delivering conduit, attaching a second medical connector housing
part to said second medical fitting, wherein said second medical
connector housing part has a first end adapted to mate with the
second medical fitting, a second end having a selected second
surface feature complementary in shape to the first surface feature
of the first housing part and a set of valves to prevent the flow
of fluid through the second medical connector housing part, and
connecting said first medical connector housing part to said second
medical connector housing part so that when assembled the first
surface feature of the first housing part couples with the second
surface feature of the second housing part to form a dedicated
fluid path from the fluid source to the patient, wherein said first
surface feature is sized and configured so as to only mate with the
complementary shaped second surface feature to prevent another
fluid delivering conduit associated with a differently configured
surface feature from being connected to the fluid receiving conduit
and wherein one of the first and second medical connector housing
parts includes a set of valves to prevent fluid flow through the
dedicated fluid path unless the first housing part is properly
mated with the second housing part, thereby preventing the
accidental administration of another fluid to the patient through
the first and second housing parts.
8. The method of claim 7, wherein the first medical connector
housing part comprises: an inner body rigidly connected to the
protrusion and containing a central fluid lumen; and an outer
sleeve surrounding the inner body configured to rotate in a first
direction about the inner body.
9. The method of claim 8, wherein the first medical connector
housing part further includes a ratchet mechanism to prevent
rotation of the outer sleeve in a second direction opposite the
first direction.
10. The medical connector of claim 9, wherein the ratchet mechanism
comprises teeth on an inner surface of the outer sleeve engaging a
pawl formed on an outer surface of the inner body.
11. The medical connector of claim 9, wherein the first medical
connector housing part is locked to the medical fitting by
inserting the protrusion into the threads and rotating the medical
connector in the second direction such that the protrusion engages
the thread, thereby screwing the first medical connector housing
part into the medical fitting.
12. The medical connector of claim 11, wherein rotation of the
medical connector in the first direction causes the outer sleeve to
rotate about the inner body while the protrusion is maintained in
an engaged position with the threads.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/124,288 filed on Apr. 17, 2002, which is a
continuation-in-part of U.S. patent application Ser. No.
09/094,433, filed Jun. 8, 1998, entitled "Safety Indexed Medical
Connectors", the contents of which are herein incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to fluid connectors, and more
particularly to fluid connectors used in medical environments and
designed to ensure the correct and appropriate administration of
medicaments to a patient.
[0003] Errors in prescribing and delivering medications to patients
are, unfortunately, common in medical practice. Many of these
mistakes result in patient injury or death, and even if the patient
recovers fully, the cost to society of induced and prolonged
hospital stays and greater patient charges are staggering. It is
estimated that at least 25,000 incidents involving drugs
administered to a patient by the wrong route occur annually, all of
which are the result of preventable human error. The most common
cause of confusion in route of administration is the universal
nature of medical connectors and injection sites. Most medical
connectors and infusion/injection sites are universal couplers that
are designed to mate with and therefore accept most syringes and
other fluid delivering devices. The most common types of infusion
sites are rubber septa designed to be pierced by a needle, and
female luer connectors designed to be connected to a syringe or
medical tubing with a male luer fitting, either by friction fit or
threaded lock. Both types of sites are commonly included in
intravenous infusion tubing, on the ends of heparin locks, in
stopcocks in all types of intravenous, arterial, epidural, and
other type connectors, and even in devices not designed for
medication or fluid infusion at all, such as esophageal
stethoscopes and urinary catheters. The universal employment of
rubber septum injection ports and female luer connectors is
directly coupled to thousands of errors in which a medication or
fluid designed to be given by one route has inadvertently been
given by another route, sometimes with disastrous consequences.
[0004] Several additional problems arise from use of current
technology. The use of needles for connecting infusion lines and
the administration of medicines has led to many cases of
needlestick injury and transmission of blood borne infections,
including hepatitis and AIDS. The infusion of proper fluids through
the needle and coupler is also prone to inadvertent failure due to
unwanted disconnection of the needle from the rubber septum.
Moreover, repeated piercing of the coupler with the needle can
taint the sterile fluid pathway.
[0005] The prior art has attempted to address the foregoing
concerns by employing needleless systems and locking connectors,
but they too are designed as universal connectors which are subject
to route of administration errors. For example, a patient may be
connected to multiple fluid delivering devices, hence forming
multiple fluid pathways. The medical connectors are typically
coupled to fluid delivering and receiving devices by universal type
connectors, such as luer fittings. Hence, an attending person may
accidentally apply a medicament to the wrong fluid pathway since
the universal connector accepts or can be coupled to conventional
fluid delivering devices.
[0006] It is an object of this invention to develop a needleless,
relatively safe, locking connector system that is fluid
path-specific. That is, the system should allow only infusions or
injections of the proper type to be connected to the specific
catheter or tubing type. In order to maintain efficiency and ease
of locating the proper connectors, especially in an emergency, the
types of connectors should be easily determinable by
inspection.
[0007] Other general and more specific objects of the invention
will in part be obvious and will in part appear from the drawings
and description which follow.
SUMMARY OF THE INVENTION
[0008] The invention described herein is designed to eliminate,
prevent or reduce the occurrence of unwanted or accidental
administration of fluids to the wrong fluid pathway through known
universal connectors. The present invention addresses this problem
by replacing the universal connector with unique specially
configured male/female connector pairs, each coded for use with
only one type of medical catheter or device (e.g., peripheral
intravenous catheter, central venous catheter, arterial catheter,
epidural catheter, dialysis catheter).
[0009] The present invention specifically describes in one aspect a
family of medical connectors designed to attach a medical infusion
or injection device to a patient catheter or device. It is
comprised of pairs of male-female locking connectors. The mating
surfaces are uniquely indexed so that only complementary halves of
the appropriate set connect together. Preferably, the fluid path
runs through the length of the connector halves, with complementary
shape- and/or size-indexed pieces constructed coaxially with the
fluid path in each half connector. When in use, the two halves are
pressed together and via a number of possible techniques locked
into position, thus completing the fluid path. The ends of the
connector halves opposite the mating surfaces can attach to
standard luer-type medical connectors, preferably female on one
half and male on the other, in order to interpose the mated
connector between a catheter or other patient receiving device and
an infusion or fluid delivering device, such as an intravenous
tubing set or a syringe. In certain specialized applications,
female-female, or male-male outer ends can be incorporated; in
still others, non-luer fittings may be incorporated, for example to
facilitate piercing a vial or intravenous fluid container.
[0010] According to another aspect of the invention, one half of
the connector can be permanently attached to a catheter, infusion
tubing set or syringe. This facilitates use of the device in
applications which are especially sensitive to errors in fluid or
medication administration, to ensure correct drug administration in
emergency situations. In another aspect, a valve can be
incorporated into either or both halves of the connector pair which
closes the fluid path when the two halves are not mated together,
or may incorporate irreversible locking mechanisms to attach the
connector half permanently to a catheter, tubing end or
syringe.
[0011] The present invention also provides for a medical connector
suitable for use in coupling a fluid delivering conduit to a fluid
receiving conduit, such as a catheter adapted for insertion within
a patient. The medical includes first and second connector housing
parts having a first end sized to mate with the fluid receiving and
delivering conduits and a second end having a selected first
surface feature formed thereon. When assembled, the first surface
feature of the first housing part couples with the second surface
feature of the second housing part to form a fluid connection
therebetween.
[0012] The present invention further provides a locking mechanism
for locking the medical connector to a fluid conduit. The locking
mechanism may include a ratchet mechanism that allows rotation of
the medical connector about the fluid path in one direction only.
As a result, once the medical connector has been attached to the
fluid conduit, removal of the medical connector from the fluid
conduit is difficult or impossible.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The foregoing and other objects, features and advantages of
the invention will be apparent from the following description and
apparent from the accompanying drawings, in which like reference
characters refer to the same parts throughout the different views.
The drawings illustrate principles of the invention and, although
not to scale, show relative dimensions.
[0014] FIG. 1 is a perspective view of one embodiment of a medical
connector incorporating a selectively configured connection
mechanism employing both raised and recessed surface features
according to the teachings of the present invention.
[0015] FIG. 2 is a perspective view of the medical connector of
FIG. 1 disposed in a closed or assembled position.
[0016] FIG. 3 is an end view of the two half portion of a medical
connector illustrating another embodiment of the connection
mechanism in accordance with the teachings of the present
invention.
[0017] FIG. 4 is an unassembled perspective view of another
embodiment of the medical connector in accordance with the
teachings of the present invention.
[0018] FIGS. 5A through 5D illustrate various constructions of the
connection mechanism in accordance with the teachings of the
present invention.
[0019] FIGS. 6A through 6C illustrate various constructions of a
locking mechanism suitable for use with the medical connector of
the present invention.
[0020] FIGS. 7A through 7D illustrate the manner in which the
medical connector of the present invention can be coupled to
various fluid delivering or receiving devices.
[0021] FIGS. 8A-8D illustrates the medical connector including a
ratchet mechanism for locking the medical connector to a fluid
conduit, illustrated as a syringe, according to one embodiment of
the present invention.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
[0022] This present invention involves one or more, such as a
family, of medical connectors with male and female halves which are
shape- and/or size-indexed so that only complementary pairs of
connectors may be coupled and then employed to deliver a fluid a
patient along a selected fluid pathway. The connectors of the
present invention help avoid accidental administration of a fluid
to the wrong fluid pathway by ensuring that fluid delivering
devices can only be connected to a fluid receiving device having a
specific configuration. The present invention may be adapted to
many different medical applications in the field of medical
connectors, injection apparatus, and infusion devices.
[0023] FIG. 1 shows a perspective view of two general medical
connector portions, designated as a first male medical connector
portion 1 and a second female medical connector portion 3, which
incorporate in their first ends, respectively, a protuberance 15
and a cavity 25 complementary in shape to the protuberance. These
surface features allow the two connector halves to fit together in
a fluid-tight seal, as shown in FIG. 2. A fluid path runs through
the long axis 4 of the first portion 1 and the second portion 2.
Specifically, the medical connector portion 1 includes a central
fluid lumen 10 that extends longitudinally therethrough from one
end to the other. Likewise, the other medical connector portion 3
includes a central fluid lumen 60 that passes longitudinally
therethrough. When assembled, the fluid lumens 10, 60 are disposed
in registration with one another to form an intermediate fluid
pathway that connects a fluid delivering device to a fluid
receiving device.
[0024] The illustrated first medical connector portion 1 has a
surface feature formed on a mating end, such as the raised
protuberance 15. The protuberance 15 can have many shapes, and as
illustrated is an annulus having an outer, flattened surface 5 that
is disposed generally perpendicular to the long axis 4 of the
connector 1 and the lumen 10. The second medical connector 3 has a
complementary shaped surface feature, such as recess or cavity 25,
which seats the protuberance 15 of the first connector portion 1.
The recess 10 ends in a floor stop 65 which is designed to stop the
advance of the protuberance 15 when disposed within the recess. A
central lumen 65 forms a second fluid pathway within the connector
3 and extends substantially from the recessed first end to the
opposite end.
[0025] The matable complementary shaped surface features 15,25 of
the medical connectors are designed to be incompatible with
conventional type fittings, such as luer taper fittings, which are
a family of friction-fit, locking connectors of standardized size
and shape, widely used in medical applications, and well known in
the art. The surface features can have a variety of shape and
sizes, such as illustrated in FIGS. 5A-5D.
[0026] The illustrated first medical connector 1 includes an outer
housing having a recessed end which forms an outer annulus 26 that
is coaxially disposed about the protuberance 15. The outer annulus
26 includes a number of channels 28 formed therein, which terminate
in a lock or key portion 29, formed towards an intermediate portion
of the medical connector. The medical connector 1 can further
include a series of circumferential grooves 32 formed about the
outer body portion of the connector. The grooves are preferably
sized to seat a locking arm, FIG. 6C, that can be formed on the
other medical connector part for locking or securing the two
connector components together to form a fluid-tight seal.
[0027] With further reference to FIG. 1, the medical connector
portion 1 further includes a stepped outwardly extending housing
portion 34, and a further outwardly extending portion 36 that
extends along the longitudinal axis 4. This portion terminates in a
flange or collar 55 adapted to connect with a fluid receiving or
delivering device. The other medical connector part 3 includes an
outer housing portion 38 configured complementary to the mating end
20 of the other connector portion 1, so as to be able to couple
thereto in a fluid sealing arrangement. Specifically, the outer
housing portion 38 of the medical connector 3 terminates in a tab
portion 35 that is designed to seat within the key portion 29 of
the other medical connector portion 1. The connector 3 is further
tapered at an intermediate portion 42 and includes a cut-out
portion 44. The connector terminates in a chamfered end 70 having
an axially extending connector 50.
[0028] The two medical connector portions 1, 3 when mated together
can either be held together by a friction fit arrangement, by the
key locking scheme illustrated in FIG. 1, or by a number of other
locking schemes, as shown in FIGS. 6A through 6C. The illustrated
locking scheme involves seating the protuberance 15 in the recess
25 such that the mating portions of the two connectors are
coaxially arranged. Furthermore, the outer housing 38 of connector
3 has an end 30 that seats within the space or channel 31 formed
between the protuberance 15 and the outer annulus 26. Likewise, the
outer end 20 of the protuberance is coaxially arranged with and
seats about the outer surface or shell 38. In order to assemble the
connector parts, the portions 1 and 3 are pressed together, and the
outer housing portions rotated around its long axis so that the tab
35 engages and locks with the complementary key portion 29. The
assembled medical connector portions form a secure, fluid-tight
medical connector 40 that couple together various fluid devices,
such as catheters, needles, or syringes connected to the luer
fittings 55 and 50, as illustrated in FIG. 2.
[0029] The illustrated medical connector portions 1, 3 of the
invention are designed to be application or path-specific. The male
or first connector portion 1 of the medical connector 40 is
configured to mate with only one type of mating surface, although
selected others are also contemplated, and will not mate with other
female type connectors. Thus a connector designated, for example,
for epidural catheter injections is generally incapable of
connection to a syringe intended for intravenous injection absent
the specially configured surface feature. The identity of the
connector type is readily recognizable by the skilled artisan from
the shape or design of the mating surfaces, as well as from
distinctive markings on the outer surfaces of the half connectors.
These markings can include textured features, color coding and/or
text labels, such as labels 70.
[0030] Each medical connector portion 1, 3 has an end 55, 50
opposite the mating surface or ends 20, 30 that are adapted to mate
to a fluid delivering device, such as catheters, needles, syringes
or other medical devices. In the illustrated connector of FIG. 1,
the ends 55, 50 can be standard luer taper fittings, either slip or
locking type, which are easily connected to the fluid delivering or
receiving devices. Luer type fittings are well known and well
characterized, and need not be described further herein. The use of
safe and secure luer-type fluid fittings allow the safety medical
connector 40 to be interposed between standard medical components
now in widespread use. The medical connector 40 can also be
permanently incorporated into various catheters, connectors,
syringes, tubing sets, and other devices designed for patient
connection, as shown in FIGS. 7A-7D.
[0031] FIG. 3 illustrates another type of connector design suitable
for use in accordance with the present invention. The illustrated
connector includes two connector portions 60, 62 designed to join
together to form a fluid-tight seal for the injection or infusion
of a medication or medical fluid, or alternatively for the
evacuation of a body fluid, via a catheter or device placed into
the patient's vein, artery, epidural or spinal space, or other body
compartment. The medical connector portions 60 includes a
quadrilateral shaped raised surface feature 66 extending from one
end 60A. The connector includes a fluid lumen 68 formed therein
that extends between the connector ends. The other connector
portion 62 has a recessed surface feature 72 complementary in shape
to the raised feature in order to accommodate and properly seat the
raised feature to form a fluid tight seal. According to one
practice, the end region 62A includes a cavity 72 that has a floor
portion 74. The floor portion is apertured with an opening that
defines the fluid lumen 70. The lumen extends between the connector
ends.
[0032] When assembled, the protuberance 66 seats within the cavity
72 to dispose the lumen 68 in fluid communication with the lumen 70
to form a continuous fluid path along the assembled connector and
between, for example, an infusion or injection source and a patient
catheter. The two connector portions 60, 62 can be locked together
using a variety of different schemes as discussed below. The locked
pair of medical connector portions can include additional
connection sites (such as luer fittings) on the ends opposite the
mating surfaces 60A, 62A which allow the device to be inserted
between the patient and the injection, infusion, or evacuation
source. For example, the basic design can consist of standard luer
taper fittings attached to each medical connector half. Therefore,
an epidural catheter 80 can be connected via its female luer hub
adapter 82 to a male luer fitting 84 coupled to one end of a
medical connector, generally illustrated as medical connector
portion 86, configured in accordance with the present invention.
The connector 86 couples to the other connector half to complete
the medical connection. According to one practice, the illustrated
connector 86, when not coupled to its mating connector, generally
cannot be connected to any standard syringe or medical tubing which
is devoid of a complementary surface feature.
[0033] FIGS. 5A through 5D illustrate still other embodiments of
the surface features which can be formed on the mating ends of the
medical connectors in accordance with the present invention. In
each case, a complementary pair of protuberances and recesses are
incorporated into the medical connectors. In FIG. 5A, the
protuberances can have a variety of geometric shapes, which are
arranged coaxially around the lumen 10. The shapes of the surface
features can further include a triangle 100, square 105, pentagon
110, hexagon 115, or other regular polygon or quadrilateral shape.
As is readily apparent to those of ordinary skill, each illustrated
surface feature can replace the cylindrical protuberance 15 of FIG.
1. The raised surface features fit into a complementary shaped and
sized cavity formed in the other medical connector half.
[0034] FIGS. 5B and 5C illustrate employing raised surface features
that have varying sizes. In these instances, the lumen 10 is
surrounded by a cylindrical protuberance of small 130, intermediate
135, or larger 140 diameter, or alternatively a regular polygon of
small 145, intermediate 150, or larger 155 size. FIG. 5D
illustrates employing radial projections in an outer surface of the
connector half, to effectuate radial pin indexing. In this
configuration, radially spaced pins 160 are arranged
circumferentially about the protuberance 15. These pins uniquely
mate with complementary slots 165 arranged radially within the
walls of the cavity 25 formed in the other connector half.
[0035] The foregoing medical connectors can be fashioned from hard
plastic or other suitably minimally deformable material, so that
incompatible connector halves cannot mate in a fluid-tight manner.
Attempts to do so will cause the fluid path to leak, preventing
inadvertent injection. Integrity of the fluid path can be ensured
either by a tight friction fit between the complementary connector
parts, or by the inclusion of an integral rubber or other
deformable gasket on the male portion of the connector pair. This
gasket would be slightly larger in its non-deformed state than the
complementary female half connector's cavity, so that when the two
connectors are mated, the gasket deforms and causes a tight
seal.
[0036] Two complementary medical connector portions can be joined
together to form a complete medical connector. Once assembled, the
connector portions can be locked into the mated or joined position
in a variety of ways. Some examples of locking arrangements
suitable for use with the medical connector of the present
invention are illustrated in FIGS. 1 and 6A through 6C. As
described above, the connector portions 1 and 3 of FIG. 1 include a
key and tab engagement arrangement to secure the connector halves
together. FIG. 6A illustrates a pair of medical connectors 200 and
205 which can be assembled and held together with a simple friction
fit. In this configuration, the mating portion of connector 200 is
slightly smaller in size than the complementary connector 205 so
that when engaged, sufficient force is required to separate the
connector pair such that ordinary injection pressures do not
separate them. Specifically, the medical connectors 200, 205
require some amount of force to separate the connector portions.
The tolerances of the two mating medical connector portions are
such that the pressure in the fluid delivering or receiving
conduits attached to the connector are generally insufficient to
drive the pair apart.
[0037] FIG. 6B illustrates another of securing or locking the
connectors 300 and 320 together. In this embodiment, the connector
305 includes a stepped axially extending lip portion 305 formed on
the mating end of the connector. The lip of the larger connector
includes a slightly raised portion or detent 306 extending radially
inwardly towards or into the lumen. The lip 305 is adapted for
engagement with a complementary channel or indent formed in the
mating end of the other connector 320, which is of slightly smaller
diameter. The two connector halves can lock together with a pushing
action, with one side designed to pass over the other. When
assembled, the smaller connector 320 is pushed within the larger
connector half 300 until the lip 305 engages the complementary
indent 310, thereby securing the connector portions together.
[0038] FIG. 6C shows the similar arrangement of two outer housings
of slightly different diameters 300 and 320 with slots 400 formed
on the outer surface of connector 320, which engage slightly
spreadable or deformable fingers 405 attached to and extending from
the other connector half.
[0039] Still other embodiments of securing mechanisms include
providing connector portions that contain a central fluid lumen,
and ending in luer or other fittings for connection to medical
tubing, syringes, or catheters. The entire inner portion of the
connector is adapted to spin freely around the axis of the fluid
lumen. When assembling together the two medical connector halves,
the inner portions of the connectors mate together, and then the
outer housing portions of the connectors are twisted together to
lock them. Several mechanisms for locking the outer portions are
possible. The two outer housings could be designed with
complementary deformable tabs and slots which engage when twisted
together, threaded ends which screw together, or fingers on one
part which lock into slots on the other part, as described above in
connection with FIGS. 6A through 6C. Another embodiment of a
securing mechanism can include configuring the inner mating
portions of the connector portions so as not to spin along the axis
of the fluid lumen.
[0040] As described above, the foregoing medical connectors
function as a basic interface between standard fluid delivering and
receiving devices, such as standard catheters and infection
sources, via standard medical luer fittings. In the usual
application, one connector portion of the present invention
contains at its non-mating end a male luer fitting with or without
a standard twist-lock feature, and the other connector contains a
similarly positioned female luer fitting. In certain specialized
applications, twin female or male luer adapters could be
incorporated.
[0041] This medical connectors of the invention can also be fitted
with connectors at the non-mating ends that allow its connection to
other medical devices and containers. In one important embodiment
of this invention, one connector half is permanently fused to or
incorporated into a standard medical infusion device, so that use
of a complementary connector is mandatory to access the catheter or
device. For example, an epidural catheter adapter, which typically
grips a 18 to 21 G epidural catheter and ends in a female luer
fitting, is mounted to one end of the medical connector half. Only
a syringe or tubing set incorporating or fitted with the
complementary half connector can be used with this type of epidural
catheter. Any catheter, injection adapter, tubing set, syringe, or
device connecting to a patient catheter and currently using luer
universal connectors can be adapted to incorporate half connectors
of a given type from the present invention. The invention thus
allows a family of safety injection sources and catheters to
replace the inherently less safe universal connectors in wide use
today.
[0042] The foregoing safety medical connectors are designed to be
interposed between existing devices for medical infusions,
injections, or aspirations. An additional feature of the present
invention is the fusion of a half connector as illustrated in FIG.
1 into a standard medical connector or device. FIGS. 7A through 7D
illustrate the incorporation of a safety connector half into an
epidural catheter connector 500, which in turn is connected to an
epidural catheter 505. Any of the mating and locking configurations
of the present invention, for example the rectangular surface
feature 510, can be incorporated into the end of the epidural
catheter connector. The epidural catheter connector in turn mates
with a complementary safety connector half 520. This connector half
includes a complementary shaped surface feature that ensures that
only medications intended for epidural delivery are injected
through the epidural catheter, since only a specific surface
feature 510 can mate with the connector half 520.
[0043] FIG. 7B illustrates another example of attachment mechanisms
adapted for use with the medical connector of the present
invention. The illustrated medical connector can be coupled to a
hollow sharpened spike designed for piercing bags of intravenous
fluids, blood products, or premixed intravenous medications; a
connector to feeding tubes; or a connector for certain specialized
catheters used in peritoneal dialysis. Specifically, a half
connector 1 is incorporated into a tubing set for infusion of
fluids or medications into a patient, typically comprised of tubing
540 and a spike 535 for piercing a container of fluid or
medication, which can be seen to be infusing through a transparent
drip chamber 530. In still another configuration, as shown in FIG.
7C, a half connector 1 is incorporated into a syringe 545. In
another embodiment, as shown in FIG. 7D, a half connector 1 is
incorporated into a three-way stopcock 550 which allows entry of
medication or withdrawal of fluids or medications from a tubing set
555.
[0044] Other variations of the basic design of the medical
connector of the present invention are contemplated by this
invention and thus form part of the description. First, one medical
connector half may be fused permanently or incorporated into an
existing medical infusion or injection device. For example, a
syringe prefilled with a medication that can only be given safely
by a certain route could be fashioned with a half connector on its
end. Only by mating with a catheter fitted with the appropriate
complementary connector part (perhaps also permanently mounted) can
the injection be given. Tubing sets designed for particular
applications such as epidural anesthetic infusions can be fashioned
with injection sites which only connect to other complementary
connector parts. Thus, while allowing simple and needleless
injection of additional medications, inadvertent injection of
inappropriate medications would be significantly less likely, and
hence prevented.
[0045] According to another embodiment, shown in FIGS. 8a-8d, the
illustrative medical connector may include a ratchet mechanism to
lock the medical connector to a fluid conduit. As shown in FIGS.
8a, a syringe 546 or other fluid delivering device includes a
medical fitting 548 having screw threads 547 for receiving the
medical connector 1'. As shown in FIG. 8b, the medical connector
includes protrusions, such as teeth 550a and 550b, formed on the
outwardly extending portion 36' that extends along the longitudinal
axis. The teeth 550a, 550b screw into the threads 547 of the
syringe 546 to couple the medical connector to the syringe 546.
[0046] As shown in FIGS. 8b and 8c, the medical connector 1'
includes an outer sleeve 560 and an inner body 561, which is
integral with the outwardly extending portion 36' and includes the
central fluid lumen 10' passing longitudinally therethrough. The
outer sleeve 560 of the medical connector is adapted to spin about
the inner body 561 in one direction only, illustrated by the arrow.
The outer sleeve 560 include teeth on an inner surface that mesh
with a pawl of the inner body 561 to prevent backward motion of the
outer sleeve 560. One skilled in the art will recognize that any
suitable mechanism for imparting, governing or preventing motion of
the outer sleeve 560 relative to the inner body 561 in order to
allow effective movement of the outer sleeve around the inner body
in one direction only may be utilized.
[0047] When the medical connector 1' is coupled to the syringe 546,
as shown in FIGS. 8c and 8d, unscrewing of the medical connector
from the syringe is difficult or impossible. The medical connector
1' is locked to the syringe 546 by inserting the outwardly
extending portion 36' into the medical fitting 548 and rotating the
medical connector in a second direction opposite the direction of
the arrow. When the medical connector is rotated in the second
direction, relative motion between the outer sleeve 560 and the
inner body 561 is prevented by the ratchet mechanism and the outer
sleeve 560 and the inner body 561 rotate together as one collective
body. The teeth 550a, 550b of the medical connector 1' engage the
threads 547 of the fitting and follow the ramped edge of the
threads until the medical connector 1' is tightly secured to the
syringe 546. However, when a user attempts to unscrew the medical
connector 1' from the syringe 546 by rotating the medical connector
about the longitudinal direction in the direction of the arrow
(i.e. opposite the direction in which the medical connector was
rotated to screw the medical connector to the syringe), the outer
sleeve 560 rotates without turning inner body 561, extending
portion 36' and teeth 550a, 550b. The teeth 550a, 550b remain
lodged in the threads 547 of the fitting 548 and the medical
connector 1' remains locked to the medical fitting 548. The
relative movement of the outer sleeve 560 while the inner body 561
remains fixed thus prevents or impedes unscrewing of the medical
connector from the syringe.
[0048] The illustrative medical connector 1' modifies the interface
of the syringe 546, such that the syringe 546 can only mate with
and form a fluid tight seal with a fluid conduit having a
corresponding medical connector 3', shown in FIG. 8d, coupled
thereto. According to the embodiment shown in FIGS. 8a through 8d,
the first medical connector 1' includes slots 165' for receiving
radially spaced pins 160' on the second medical connector 3'. The
outer sleeve 561 includes internal threads 570 for receiving the
pins 160' of the corresponding connector 3'. The central fluid
lumen 10' of the first medical connector portion 1' extends
longitudinally therethrough from one end to the other. Likewise,
the complementary medical connector portion 3' includes a central
fluid lumen 60' that passes longitudinally therethrough and is
adapted to receive the protruding central fluid lumen 10' of the
first connector portion 1'. To couple the medical connectors, the
pins 160' are inserted into the complementary slots 165' and
screwed into the threads 570, such that the first central fluid
lumen 10' is inserted into the second central fluid lumen 60'. The
assembled medical connector, comprising the first medical connector
1' and the second medical connector 3' thus forms a continuous
fluid path that sealingly connects the syringe 546 and a fluid
receiving device (not shown) that is connected to the second
medical connector 3'.
[0049] In other designs, either or both medical connector portions
can be fitted with a valve which is disposed in a normally closed
position but is opened by appropriate mating with a complementary
connector. A spring loaded mechanism closes the valve whenever the
connector parts are disconnected, preventing fluid leaks and
contamination of the lumen. The connector portions can also be
configured to connect to standard medical infusion devices or
catheters via essentially irreversible mechanisms so that, once
connected, the safety of the device cannot be subverted by removing
one half connector to restore a universal connection. An example of
such an application is the preservation of one lumen of a central
venous catheter exclusively for infusion of parenteral nutrition
solutions. Commonly, warning labels or adhesive tape are placed
over the rubber septum cap on the end of such a port, but these are
easily subverted. A locked half connector from the present
invention would all but eliminate this problem. Two such methods
for locking the connectors are as follows. First, a modified
screw-type male luer adapter with a wedge shaped enlargement
incorporated into the screw threads may be substituted for an
ordinary male luer adapter. A tab on the circumferential edge of a
standard female luer adapter normally engages the threads in the
male screw-type luer connector. When it meets the wedge in the
threads of the modified adapter described here, it follows the
ramped edge of the wedge, slightly deforming the threaded connector
until it crosses the end of the wedge and returns to the threaded
path. Because the wedge is placed so that the narrow end is
contacted first during clockwise (tightening) rotation of the male
luer adapter, unscrewing of the adapter once the wedge has been
passed will be very difficult or impossible.
[0050] A second method for locking the present invention to an
existing female luer adapter is to dispose a coaxial collar about
the adapter. The inner male screw adapter is of standard design,
and an outer collar is adapted to spin about its long axis (which
includes the fluid path). Teeth arranged in the space between the
male luer screw portion and the outer collar allow the outer collar
to turn the inner male luer screw fitting only in the clockwise
direction. Counterclockwise rotation is impossible because the
teeth do not engage, and therefore once the modified male luer
adapter has been screwed onto the female luer adapter, unscrewing
them is difficult or impossible.
[0051] Still another modification of the connector of the invention
is a family of accessory caps for covering the unmated half
connectors of the basic device or its modifications as described
elsewhere in this section. These caps have inner surfaces
complementary to the male or female connector halves and insert
over the mating surface of the connector half, preferably with a
friction-fit.
[0052] This invention is designed to be used in both routine and
emergency medical care. As such, simple and rapid identification of
the complementary half connectors is important. Besides inspection
of the mating surfaces themselves, a variety of techniques may be
utilized to ease identification of the connectors (see Section 5).
The preferred implementation of this technology into medical
practice would involve standardization of the various connector
types to be used only for certain catheters. For example, there
could be one type only used for epidural catheters, one for
peripheral intravenous catheters, and another for central venous
catheters.
[0053] In certain applications, the medical connectors of the
present invention may be advantageously employed with indwelling
lines, i.e., central and peripheral intravenous lines, to offer
selectivity relative to the fluid delivering device. For example, a
syringe filled with a medicament that can be safely administered
both peripherally and centrally, such as morphine, should be able
to mate, via the medical connectors of the present invention, with
the central and peripheral intravenous lines. In this embodiment, a
pair of first housing parts having the same surface feature are
coupled to both fluid receiving or indwelling pathways. The syringe
(fluid delivering device) has coupled thereto a connector half that
has a shape complementary to the shape of the other surface
feature, thus enabling this connector and syringe to couple to both
fluid pathways, and nothing else, if desired. However, a medicament
that is not safely administered peripherally, such as potassium
chloride, can be pre-filled in a syringe that could mate only with
the connector half associated with the central line. Hence, the
central intravenous line or pathway mates with both the central and
peripheral compatible syringes, but the peripheral line connector
only mates with the peripheral syringe. The central and peripheral
lines can be manufactured with such fittings as integral parts, or
as irreversibly attachable connectors when site specificity is
warranted.
[0054] The general concept embodied in this technology, in summary,
is that medical connectors are made path-specific rather than
universal. This general description is of a pair of connectors
disposed between standard fluid delivering and receiving
devices.
[0055] It will thus be seen that the invention efficiently attains
the objects set forth above, among those made apparent from the
preceding description. Since certain changes may be made in the
above constructions without departing from the scope of the
invention, it is intended that all matter contained in the above
description or shown in the accompanying drawings be interpreted as
illustrative and not in a limiting sense.
[0056] It is also to be understood that the following claims are to
cover all generic and specific features of the invention described
herein, and all statements of the scope of the invention which, as
a matter of language, might be said to fall therebetween.
* * * * *