Syringe needle abstract
A spinal syringe and needle for preventing the inadvertent injection
of an intravenous drug spinally includes a needle engagement extension
on the spinal needle defining an opening of a first diameter, a
syringe engagement extension on the spinal syringe defining an opening
of a second diameter, the syringe engagement extension engageable
with the needle engagement extension to operatively connect the
needle to the syringe. The first and second diameters are dimensioned
such that a surface of the syringe engagement extension is in frictional
engagement with a surface of the needle engagement extension, the
first diameter is substantially the same as the diameter of an opening
defined by the engagement extension of a typical syringe and the
second diameter is substantially the same as the diameter of an
opening defined by the engagement extension of a typical needle.
A system and method for preventing the inadvertent injection of
an intravenous drug spinally and a spinal drug intravenously includes
a spinal needle and a spinal syringe for holding and dispensing
the drug to be injected spinally, the spinal syringe operatively
connectable to the spinal needle. An intravenous syringe is provided
for holding and dispensing the drug to be injected intravenously,
the intravenous syringe operatively connectable to the intravenous
needle. The intravenous needle cannot be operatively connected to
the spinal syringe and the spinal needle cannot be operatively connected
with the intravenous syringe thereby preventing the inadvertent
injection of the drug in each syringe through an incorrect needle.
Syringe needle claims
What is claimed is:
1. A spinal syringe operatively connectable with a spinal needle
for spinal injection of a drug, the syringe being incompatible for
operative connection with a connector of a typical needle the connector
having an outer end, the syringe comprising: (a) a nozzle for operatively
connecting the syringe to the spinal needle, the nozzle having a
conduit extending axially therethrough for delivery of the drug
from the syringe to the needle and comprising an outer tip; (b)
the tip extending about an outer end of the conduit dimensioned
to contact the outer end of the connector of the typical needle
to prevent operative connection of the syringe with the typical
needle.
2. The syringe of claim 1 wherein the tip is circular with an outer
diameter greater than 4.315 and an inner diameter less than 7.73
millimeters.
3. The syringe of claim 2 wherein the inner diameter is less than
the outer diameter by at least 0.5 millimeters.
4. A spinal needle operatively connectable with a spinal syringe
for spinal injection of a drug, the spinal syringe having a nozzle
with a conduit extending axially therethrough, the needle being
incompatible for operative connection with a nozzle of a typical
syringe the nozzle having an outer tip, the needle comprising: (a)
a connector cooperating with the nozzle of the spinal syringe to
operatively connect the spinal syringe to the spinal needle to dispense
the drug; (b) the connector comprising an outer end dimensioned
to contact the outer tip of the nozzle of the typical syringe to
prevent operative connection of the spinal needle with the typical
syringe.
5. The needle of claim 4 wherein the outer end is circular with
an outer diameter greater than 3.527 millimeters and an inner diameter
less than 3.925 millimeters.
6. the syringe of claim 5 wherein and the inner diameter is less
than the outer diameter by at least 0.5 millimeters.
7. A spinal syringe and spinal needle combination operatively connectable
with one another for spinal injection of a drug, the spinal syringe
being incompatible for operative connection with a connector of
a typical needle the connector of the typical needle having an outer
end, and the spinal needle being incompatible for operative connection
with a nozzle of a typical syringe, the nozzle of the typical syringe
having an outer tip, (A) the spinal syringe comprising: (a) a nozzle
for operatively connecting the spinal syringe to the spinal needle,
the nozzle having a conduit extending axially therethrough for delivery
of the drug from the spinal syringe to the spinal needle and comprising
an outer tip; (b) the tip extending about an outer end of the conduit
dimensioned to contact the outer end of the connector of the typical
needle to prevent operative connection of the spinal syringe with
the typical needle. (B) the spinal needle comprising: (a) a connector
cooperating with the nozzle of the spinal syringe to operatively
connect the spinal syringe to the spinal needle to dispense the
drug; (b) the connector comprising an outer end dimensioned to contact
the outer tip of the nozzle of the typical syringe to prevent operative
connection of the spinal needle with the typical syringe.
8. The combination of claim 7 wherein the tip is circular with
an outer diameter greater than 4.315 and an inner diameter less
than 7.73 millimeters.
9. The combination of claim 8 wherein the inner diameter is less
than the outer diameter by at least 0.5 millimeters.
10. The combination of claim 7 wherein the outer end is circular
with an outer diameter greater than 3.527 millimeters and an inner
diameter less than 3.925 millimeters.
11. The combination of claim 10 wherein the inner diameter is less
than the outer diameter by at least 0.5 millimeters.
12. A spinal syringe and needle combination for holding and dispensing
a drug to be injected spinally into a patient, the combination not
operatively connectable with a typical syringe and typical needle
combination, the typical needle having a syringe connecting opening
for connecting the typical needle to the typical syringe, said spinal
syringe and needle combination further comprising: (a) the spinal
needle comprising a needle engagement extension defining an opening
of predetermined external diameter; (b) the spinal syringe comprising
a syringe engagement extension comprising a nozzle defining a conduit
of a pre-determined internal diameter, the syringe engagement extension
engageable with the needle engagement extension to operatively connect
the needle to the syringe to permit the drug in the spinal syringe
to be injected through the spinal needle on actuation of the spinal
syringe; and (c) the external and internal diameters are dimensioned
such that: (i) a surface of the needle engagement extension defining
the opening is in frictional engagement with a surface of the nozzle
defining the conduit; (ii) the external diameter of the needle engagement
extension opening is larger than the internal diameter of a nozzle
of the typical syringe; and (iii) the internal diameter of the nozzle
is less than the external diameter of the syringe connecting opening
of the typical needle.
13. The combination of claim 12 wherein the second internal diameter
of the nozzle is larger than the external diameter of the syringe
such that the inner surface of the nozzle is in frictional engagement
with the outer surface of the needle engagement extension.
14. The combination of claim 12 wherein the external diameter of
the syringe engagement extension is greater than 3.527 millimeters
and the internal diameter of the nozzle is less than 7.73 millimeters.
15. The combination of claim 12 wherein the needle engagement extension
has a pre-determined internal diameter which is less than 3.925
millimeters and the nozzle has a pre-determined external diameter
greater than 4.315 millimeters.
16. The combination of claim 12 wherein the inner and outer surfaces
are conical and the dimensions are compared at the smallest external
diameter of the syringe engagement extension and the largest internal
diameter of the nozzle.
17. A system for preventing the inadvertent injection of a spinal
drug intravenously and an intravenous drug spinally where a patient
requires both intravenous injection of the intravenous drug and
spinal injection of the spinal drug, comprising in combination:
(a) a spinal needle; (b) a spinal syringe for holding and dispensing
the drug to be injected spinally into a patient, the spinal syringe
operatively connectable to the spinal needle to permit the drug
in the spinal syringe to be injected through the spinal needle on
actuation of the spinal syringe; (c) an intravenous needle; (d)
an intravenous syringe for holding and dispensing the drug to be
injected intravenously into a patient, the intravenous syringe operatively
connectable to the intravenous needle to permit the drug in the
intravenous syringe to be injected through the intravenous needle
on actuation of the intravenous syringe; (e) the intravenous needle
cannot be operatively connected with the spinal syringe thereby
preventing the inadvertent injection of the drug in the spinal syringe
through the intravenous needle; and (f) the spinal needle cannot
be operatively connected with the intravenous syringe thereby preventing
the inadvertent injection of the drug in the intravenous syringe
through the spinal needle.
18. The system as described in claim 17 wherein: (a) the spinal
needle comprises a first Luer lock portion at an end of the spinal
needle; (b) and the spinal syringe comprises a second Luer lock
portion at an end of the spinal syringe which mates with the first
Luer lock portion of the spinal needle to operatively connect the
spinal needle with the spinal syringe; (c) the intravenous needle
comprising a first slip fit portion on an end of the intravenous
needle; and (d) the intravenous syringe comprises a second slip
fit portion on an end of the intravenous syringe which mates with
the first slip fit portion of the intravenous needle to operatively
connect the intravenous needle with the intravenous syringe.
19. The system as described in claim 17 wherein: (a) the spinal
needle includes a first end for insertion into the patient and a
second end opposite the first end, and wherein the second end includes
a spinal needle connector; (b) the spinal syringe includes a first
end, the first end having a spinal syringe connector attached thereto,
the spinal syringe connector operatively connectable to the spinal
needle connector to permit the drug in the spinal syringe to be
injected through the spinal needle on actuation of the spinal syringe;
(c) the intravenous needle includes a first end for injection into
a patient and a second end, and wherein the second end includes
an intravenous needle connector; and (d) the intravenous syringe
includes a first end having an intravenous syringe connector attached
thereto, the intravenous syringe connector operatively connectable
to the intravenous needle connector to permit the intravenous drug
in the intravenous syringe to be injected through the intravenous
needle on actuation of the intravenous syringe.
20. The system as described in Clam 19 wherein: (a) the spinal
needle connector comprises a first Luer lock portion and the spinal
syringe connector comprises a second Luer lock portion which mates
with the first Luer lock portion; and (b) the intravenous needle
connector comprises a first slip fit portion and the intravenous
syringe connector comprises a second slip fit portion which mates
with the first slip fit portion.
21. The system as described in claim 19 wherein: (a) the spinal
needle connector comprises a first slip fit portion and the spinal
syringe connector comprises a second slip fit portion which mates
with the first slip fit portion; and (b) the intravenous needle
connector comprises a first Luer lock portion and the intravenous
syringe connector comprises a second Luer lock portion which mates
with the first Luer lock portion.
22. The system as described in claim 19 further comprising an elongated
spinal needle passage having an opening therethrough connected to
the spinal needle connector and an elongated intravenous syringe
passage having an opening therethrough connected to the intravenous
syringe connector; wherein the internal diameter of the opening
in the intravenous syringe passage is less than the external diameter
of the spinal needle passage and wherein the internal diameter of
the opening through the spinal needle passage is less than the external
diameter of the intravenous syringe passage.
23. The system as described in claim 22 wherein the spinal syringe
connector comprises a spinal syringe passage extending therefrom
and having an opening therethrough with an internal diameter slightly
larger than the external diameter of the spinal needle passage to
permit friction fit releasable connection between the spinal needle
passage and the spinal syringe passage to operatively connect the
spinal needle to the spinal syringe.
24. The system as described in claim 23 wherein the intravenous
needle connector includes an intravenous needle passage having an
inner diameter less than the outer diameter of the spinal syringe
connector and an outer diameter greater than the inner diameter
of the spinal syringe connector.
25. The system as described in claim 19 wherein the spinal needle
further comprises an opening therethrough to direct liquid in the
spinal syringe through the spinal needle opening into the patient
and wherein the system further comprises a stylus with a first end
and a second end and a stylus head connected to the second end of
the stylus, the stylus dimensioned in diameter for insertion through
the spinal needle opening and dimensioned in length to extend to
the first end of the needle when the stylus head contacts the second
end of the needle.
26. The system as described in claim 25 wherein the intravenous
needle further comprises an opening therethrough to direct liquid
in the intravenous syringe through the intravenous needle opening
into the patient, the stylus dimensioned in width larger than the
intravenous needle opening to prevent insertion of the stylus into
the intravenous needle opening.
27. The system as described in claim 19 wherein the spinal syringe
further comprises indicia notifying a user to fill the syringe only
with a drug intended to be injected spinally.
28. The system as described in claim 27 wherein the intravenous
syringe further comprises indicia notifying a user to fill the syringe
only with a drug intended to be injected intravenously.
29. The system as described in claim 17 wherein the spinal needle
comprises interference means for preventing operative connection
with the intravenous syringe while permitting operative connection
of the spinal needle with the spinal syringe.
30. The system as described in claim 29 wherein the interference
means comprises a contact positioned on the spinal needle to prevent
operative connection of the spinal needle with the intravenous syringe
and wherein the spinal syringe includes a contact receptacle for
receiving the contact and permitting operative connection of the
spinal syringe to the spinal needle.
31. The system as described in claim 17 wherein the spinal needle
connector is incompatible for operative connection with both a Luer
lock system of attaching a needle to a syringe and a slip fit system
for attaching a needle to a syringe.
32. In a drug delivery system for ensuring the delivering a spinal
drug spinally and an intravenous drug intravenously, the combination
comprising: (a) a spinal syringe; (b) a spinal needle operatively
connectable with the spinal syringe; (c) an intravenous syringe;
(d) an intravenous needle operatively connectable with the intravenous
syringe; (e) the intravenous syringe being incompatible with the
spinal needle to prevent the operative connection of the intravenous
syringe with the spinal needle thereby preventing the inadvertent
injection of an intravenous drug in the intravenous syringe spinally
through the spinal needle; and (f) the spinal syringe being incompatible
with the intravenous needle to prevent the operative connection
of the spinal syringe with the intravenous needle thereby preventing
the inadvertent injection of a spinal drug in the spinal syringe
intravenously through the intravenous needle.
33. A system for preventing the inadvertent injection of a spinal
drug intravenously and an intravenous drug spinally where a patient
requires both intravenous injection of a drug and spinal injection
of another drug and where the system includes a set of spinal and
intravenous needle and syringe components provided together for
substantially concurrent use, characterised in that: (a) the spinal
needle includes a spinal needle connector; (b) the spinal syringe
comprises a spinal syringe reservoir for holding the drug to be
injected spinally, the spinal syringe having a spinal syringe connector
operatively connectable to the spinal needle connector to permit
the drug in the spinal syringe reservoir to be injected through
the spinal needle; (c) the intravenous needle includes an intravenous
needle connector; (d) the intravenous syringe comprises an intravenous
syringe reservoir for holding the drug to be injected intravenously,
the intravenous syringe having an intravenous syringe connector
operatively connectable to the intravenous needle connector to permit
the intravenous drug in the intravenous syringe reservoir to be
injected through the intravenous needle; (e) the intravenous needle
connector is incompatible for operative connection with the spinal
syringe connector; and (f) the spinal needle connector is incompatible
for operative connection with the intravenous syringe connector.
34. A method of preventing the inadvertent injection of a spinal
drug intravenously and an intravenous drug spinally comprising the
steps of: (a) filling a syringe reservoir of a spinal syringe with
a spinal drug; (b) filling a syringe reservoir of an intravenous
syringe with an intravenous drug; (c) inserting a distal end of
a spinal needle into the spinal cavity of a patient such that a
proximal end of the spinal needle extends from the patient; (d)
connecting the spinal syringe to the proximal end of the spinal
needle, the spinal needle incompatible with and not operatively
connectable to the intravenous syringe; (e) connecting an intravenous
needle to the intravenous syringe, the intravenous needle incompatible
with and not operatively connectable to the spinal syringe; (f)
injecting the spinal drug into the spinal cavity of the patient
using the spinal syringe and needle; and (g) injecting the intravenous
drug intravenously into the patient using the intravenous syringe
and needle.
35. A system for preventing the inadvertent injection of a spinal
drug intravenously and an intravenous drug spinally where a patient
requires both intravenous injection of a drug and spinal injection
of another drug, the system comprising: (a) a set of spinal and
intravenous needle and syringe components provided together for
substantially concurrent use; (b) the spinal needle of the set being
incompatible for operative use with the intravenous syringe; and
(c) the intravenous needle of the set being incompatible for operative
use with the spinal syringe.
Syringe needle description
FIELD OF THE INVENTION
The present invention generally relates to a syringe and needle,
and a system which incorporates that syringe and needle in combination,
for preventing inadvertent injection of a drug and more specifically
relates to a syringe for spinal drug injection which is incompatible
with a typical needle and a needle for spinal drug injection which
is incompatible with a typical syringe.
BACKGROUND OF THE INVENTION
Drugs may be injected into patients using a needle (or "cannula")
by several different methods, including injection into a vein ("intravenously")
or injection into the fluid around the spine ("spinally"),
including intrathecally, epidurally and intramedurally. Drug treatment
for particular ailments may at times require the injection of a
drug in a very specific manner. For example, it is often of critical
importance to ensure that drugs intended for intravenous injection
are not mistakenly injected spinally and vice versa. It is also
important to ensure that a drug contained in a syringe for injection
in a particular manner is not mistakenly attached to a needle used
for inappropriate injection of that drug thereby increasing the
risk that the drug will be mistakenly injected in an inappropriate
manner. For example, to ensure that a drug intended for intravenous
injection stored in a syringe is not mistakenly attached to a spinal
needle and injected spinally.
This is of particular concern in the field of chemotherapy where
very toxic drugs employed to treat particular types of cancer must
be injected in a very specific manner. For example a group of drugs
known as "vinca alkaloids" are extremely toxic when administered
in any manner other than intravenously. If these drugs are administered
in any other manner, including spinally, these drugs may be fatal
to the patient.
There have been unfortunate occurrences of mistaken injection of
a vinca alkaloid drug used in chemotherapy into a patient's spinal
region, rather than by the appropriate method of injection, that
being intravenously. A syringe containing such a drug can be accidentally
attached to a spinal needle and the drug injected spinally into
the patient, thereby causing death or serious injury to the patient.
As well, a drug in a syringe which is intended to be injected spinally
may be attached to a needle used for intravenous injection and the
drug mistakenly injected intravenously.
Many of these inadvertent injections can be attributed to human
error in either filling a given syringe intended for spinal injection
of drugs with a toxic drug intended for intravenous injection or
mixing up syringes containing various chemotherapy drugs and attaching
a syringe containing a toxic drug intended for intravenous injection
to a spinal needle and injecting that drug spinally into the patient.
As a result there is a significant need for the development of
a syringe and needle which may be employed for spinal injection
of a drug intended for spinal injection and a system incorporating
a combination of that syringe and needle which will reduce the risks
inherent in handling and injecting toxic drugs meant to be injected
only in a very specific manner. The present invention is intended
to accomplish this by reducing the opportunity for human error in
handling and injecting toxic drugs in the appropriate manner into
patients receiving those drugs.
SUMMARY OF THE INVENTION
In one embodiment of the invention a spinal syringe is operatively
connectible with a spinal needle for spinal injection of a drug.
The syringe is incompatible for operative connection with a connector
of a typical needle. The spinal syringe includes a nozzle for operatively
connecting the syringe to the spinal needle, the nozzle having a
conduit extending axially therethrough for delivery of the drug
from the syringe to the needle and includes an outer tip. The tip
extends about an outer end of the conduit and is dimensioned to
contact the outer end of the connector of the typical needle to
prevent operative connection of the spinal syringe with the typical
needle.
In another embodiment of the invention, a spinal needle is operatively
connectible with a spinal syringe for spinal injection of a drug.
The spinal syringe includes a nozzle with a conduit extending axially
therethrough. The needle is incompatible for operative connection
with the nozzle of a typical syringe, the nozzle having an outer
tip. The needle includes a connector cooperating with the nozzle
of the spinal syringe to operatively connect the spinal syringe
to the spinal needle to dispense the drug. The connector includes
an outer end dimensioned to contact the outer tip of the nozzle
of the typical syringe to prevent operative connection of the spinal
needle with the typical syringe.
In yet another embodiment of the invention, a spinal syringe and
a spinal needle combination are operatively connectible with one
another for spinal injection of a drug. The spinal syringe is incompatible
for operative connection with a connector of a typical needle, the
connector of the typical needle having an outer end. The spinal
needle is incompatible for operative connection with the nozzle
of a typical syringe, the nozzle having an outer tip. The spinal
syringe including a nozzle for operatively connecting the spinal
syringe to the spinal needle, the nozzle having a conduit extending
axially therethrough for delivery of the drug from the spinal syringe
to the spinal needle and including an outer tip. The tip extending
about an outer end of the conduit dimensioned to contact the outer
end of the connector of the typical needle to prevent operative
connection of the spinal syringe with the typical needle. The spinal
needle includes a connect or cooperating with the nozzle of the
spinal syringe to operatively connect the spinal syringe to the
spinal needle to dispense the drug. The connector includes an outer
end dimensioned to contact the outer tip of the nozzle of the typical
syringe to prevent operative connection of the spinal needle with
the typical syringe.
In another embodiment a spinal syringe and needle for preventing
the inadvertent injection of an intravenous drug spinally includes,
in combination, a needle engagement extension on the spinal needle
defining an opening of a first diameter, a syringe engagement extension
on the spinal syringe having a nozzle of a second diameter, the
syringe engagement extension engageable with the needle engagement
extension to operatively connect the needle to the syringe. The
first and second diameters are dimensioned such that a surface of
the syringe engagement extension is in frictional engagement with
a surface of the needle engagement extension, the first diameter
is smaller than the diameter of the nozzle of a typical syringe
and the second diameter is larger than the diameter of the opening
of a typical needle.
In a further embodiment, a system and method for preventing the
inadvertent injection of a spinal drug intravenously and an intravenous
drug spinally includes, in combination, a spinal needle and a spinal
syringe for holding and dispensing the drug to be injected spinally,
the spinal drug operatively connectable to the spinal needle. An
intravenous and intravenous syringe are provided for holding and
dispensing the drug to be injected intravenously, the intravenous
syringe operatively connectable to the intravenous needle. The intravenous
needle cannot be operatively connected to the spinal syringe thereby
preventing the inadvertent injection of the drug in the spinal syringe
through the intravenous needle and the spinal needle cannot be operatively
connected with the intravenous syringe thereby preventing the inadvertent
injection of the drug in the intravenous syringe through the spinal
needle.
In another embodiment, the spinal needle may include a first Luer
lock portion at an end of the spinal needle and the spinal syringe
can comprise a second Luer lock portion at its end which mates with
the first Luer lock portion to operatively connect the spinal needle
with the spinal syringe. In yet another embodiment, the intravenous
needle may include a first slip fit portion on an end and the intravenous
syringe may include a second slip fit portion which mates with the
first slip fit portion of the intravenous needle to operatively
connect the intravenous needle with the intravenous syringe.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a spinal needle, syringe and stylette;
FIG. 2 is a fragmentary enlarged sectional view of the slip fit
attachment end of a spinal syringe attached to the slip fit attachment
end of a spinal needle;
FIG. 3 is a fragmentary sectional view of the spinal needle and
its corresponding stylette;
FIG. 4 is a fragmentary sectional view of an attachment end of
a typical syringe commonly used by the medical profession adjacent
to, but not attached to, the uniquely dimensioned attachment end
of the spinal needle of the present invention;
FIG. 5 is a fragmentary sectional view of a the attachment end
of a typical syringe commonly used by the medical profession adjacent
to, but not attached to, the uniquely dimensioned attachment end
of the spinal needle of the present invention;
FIG. 6 is a fragmentary sectional view of the uniquely dimensioned
attachment end of a syringe of the present invention adjacent to,
but not attached to, a standard attachment end of a slip fit needle
commonly used by the medical profession; and
FIG. 7 is a perspective illustration of a system for preventing
the inadvertent injection of a spinal drug intravenous and an intravenous
drug spinally.
DETAILED DESCRIPTION
FIG. 1 depicts the uniquely dimensioned spinal syringe 32 and needle
34 of the present invention which are incompatible for use with
a typical syringe and needle. As used herein, the term "typical
syringe" and "typical needle" means a syringe and
needle typically used by the medical profession meeting the ANSI/HIMA
"American National Standard for Medical Material-Luer Taper
Fittings-Performance MD70.1-1983 (Revision of ANSI Z70.1-1955).
The standard provides the following dimensions, including tolerances,
for the following elements of"typical" syringes and needles:
COMPONENT SIZE (IN MILLIMETRES) Inside diameter of the needle socket
opening, Minimum 4.270 at large end (Reference 120 of FIG. 6) Maximum
4.315 Lug-to-lug diameter (Reference 158 of FIG. Minimum 7.73 6)
Maximum 7.83 Outside diameter of end of syringe nozzle Minimum 3.925
(Reference 115 of FIGS. 4 and 5) Maximum 3.990
Syringe 32 may be operatively connected to needle 34 for injection
of the drug in syringe 32 through needle 34 into a patient. Needle
34 includes cannula 54 which extends from one end of head 56. Stylette
36 may be inserted axially through cannula 54 needle 34 (as best
seen in FIG. 3) and includes generally rectangular-shaped head 50
attached at one end of elongated stylette portion 52. Stylette portion
52 is dimensioned to fit within hollow inner opening of needle 34.
Referring to FIGS. 1 and 3 head 56 includes extension 58 extending
axially from the end of head 56 opposite to cannula 54. Extension
58 includes opening 60 therein extending axially through head 56
and connecting to opening in cannula 54. Head 50 of stylette 36
includes opening 62 defined by inner surface 66 of flange 67 extending
axially within head 50 and dimensioned to contact outer surface
64 of extension 58 such that, when engaged with one another as depicted
in FIG. 3 outer surface 64 of extension 58 lies adjacent inner
surface 66 of opening 62.
As best seen in FIG. 3 stylette portion 52 is attached axially
to head 50 through axial extension 68. Stylette portion 52 is thereby
retained rigidly within head 50 and extends axially from extension
68 through openings 60 and 62 and then through cannula 54 of needle
34. The distal end of stylette opposite to the end attached to extension
68 is angled to present a sharp tip 70 at its outer end and stylette
portion 52 is dimensioned in length so as to be generally co-terminus
with tip 40 when stylette 36 is inserted into needle 34 as depicted
in FIG. 3 and FIG. 7.
Referring to FIG. 1 head 50 includes flange 72 extending in the
direction of tip 70. Head 56 includes a corresponding slot 74 which
accepts tip 72 therein when stylette 36 is positioned within needle
34. Cannula 54 includes tip 40 which is likewise angled to present
a sharp point for ease of insertion of cannula 54 into the patient.
When flange 72 is positioned within slot 74 the angled portions
of tips 40 and 70 are maintained in alignment which facilitates
insertion of cannula 54 with stylette portion 52 into the patient.
Head 56 also includes a pair of opposed wing members 76 extending
laterally from the longitudinal axis of needle 34. Head 50 includes
platform 78 at the proximal end of head 50 opposite to the end from
which stylette portion 52 extends. Platform 78 and wing member 76
are used to facilitate insertion of needle 54 with stylette 36 into
the patient as the part of the appropriate procedure for inserting
needle 34 into the patient for spinal injection of a drug. Wings
76 are used for gripping the index and middle fingers of the person
inserting the needle and platform 78 is used as a contact point
for the thumb to assist in the insertion of needle 34 and stylette
36 into the patient.
Head 56 also includes cannula support extension 80 which serves
to support cannula 54 within head 56 thereby reducing the opportunity
for lateral movement or bending of cannula 54 when pressure is applied
on tip 40 as cannula 54 is inserted into the patient.
Referring to FIG. 1 and FIG. 2 needle 54 may be attached to syringe
32 in order to dispense the drug in syringe 32 through needle 34
into the patient. Syringe 32 includes storage region 82 for storing
the drug to be injected spinally into the patient. Plunger 84 extends
into first end 90 of region 82. Plunger 84 is used in a typical
manner and when depressed within region 82 puts pressure on the
drug in region 82 to cause the drug to flow through needle 34 into
the spinal region of the patient. Syringe 32 also includes end opening
86 extending axially from one end of storage region 82 to permit
the drug within storage region 82 to exit syringe 32 through opening
86 into opening 60 of extension 58 when plunger 84 is depressed.
Syringe 32 further includes a pair of opposed wing members 88 extending
from a first end 90 of region 82. Plunger 84 includes platform 92
on plate 94 which extends in a plane perpendicular to the longitudinal
axis of plunger 84. Plunger 84 further includes longitudinal axial
extension ribs 96 extending from plate 94 at one end to inner sealed
resilient member (not shown) which provides a seal between plunger
84 and inner wall (not shown) of storage region 82 to prevent leakage
of drugs past inner sealed resilient member on depression of plunger
84 into storage region 82.
Second end 100 of storage region 82 includes securing member 102
rigidly secured to end 100 about the periphery of end 100. Securing
member 102 further includes axial extension 104 forming opening
106 therein. Inner wall 108 of extension 104 is dimensioned similar
to inner surface 66 of head 50 and accepts extension 58 therein
such that outer surface 64 contacts inner wall 108. However in this
case inner wall 108 is dimensioned to more tightly engage outer
surface 64 to provide a relatively secure friction fit engagement
between inner wall 108 and outer surface 64. This ensures that there
is sufficient frictional force between inner wall 108 and outer
surface 64 to prevent separation of syringe 32 from needle 34 when
syringe 32 is moved outwardly from the patient to remove needle
34 from that patient after the drug in storage region 82 has been
injected spinally into the patient. To assist in securing these
components surfaces 64 and 108 may be conically-shaped with a larger
diameter at the outer end 150 of extension 104 as compared to inner
end 152. Correspondingly, the outer end 154 of extension 58 is of
a small diameter as compared to inner end 156 of extension 58. This
facilitates the alignment and insertion of extension 54 into extension
104 to frictionally engage with one another. The taper of surfaces
64 and 108 is the same, preferably about 6 percent (that is a change
of 0.060 millimeters in diameter per 1 millimeter length).
As discussed below with respect to FIG. 7 syringe 24 is of standard
size containing a tip suitable for attaching slip fit Luer lock
combination needle 26. FIG. 4 depicts slip fit syringe 110 typically
employed by the medical profession and of standard dimension as
described above. Syringe 110 is shown adjacent spinal needle 34
of the present invention. Wall 112 of extension 58 of needle 34
is circular of inner diameter 114 at end 69 forming opening 141.
Wall 116 which is also circular, of nozzle 109 is also of inner
diameter 114 at tip 63 forming opening 140. Wall 116 cannot extend
about wall 112 in order to engage and secure needle 34 to syringe
110 in an operative manner. Wall 116 cannot fit within wall 112
into opening 141 as the diameter of wall 112 and 116 are the same.
If tip 63 of syringe 110 is moved to a position against extension
58 end 69 of connector 57 contacts tip 63 of syringe 110. As a
result it is not possible to operatively attach syringe 110 to needle
34.
FIG. 5 depicts a typical Luer lock syringe 24 adjacent spinal needle
34 of the present invention. Luer lock syringe 24 is of a standard
diameter typically used by the medical profession for drug injection.
Syringe 24 includes extension or nozzle 59 having a circular wall
118 forming an opening 142 of diameter 114 that is equivalent to
diameter 114 of syringe 110 depicted in FIG. 4. A typical Luer lock
syringe 24 includes end 120 which accepts either a typical Luer
lock needle or a typical slip fit needle therein for attachment
of the syringe to a typical Luer lock or slip fit needle. However
in the case of spinal needle 34 wall 112 is circular of diameter
114 the same diameter as wall 118. Outer end 59 of connector 57
of wall 112 will contact outer tip 65 of wall 118 thereby preventing
operative connection of syringe 24 to needle 34.
As discussed above, a typical syringe 110 120 has an outside diameter
115 between 3.925 millimeters and 3.990 millimeters at tip 63 65
of nozzle 109. Therefore, in order to ensure that needle 34 of the
present invention may not be operatively connected to nozzle 109
of a typical slip fit syringe 110 (FIG. 4) or a lure lock syringe
120 (FIG. 5) inner diameter 114 of wall 112 at end 69 must be less
than the outer diameter 115 of wall 116 at tip 63. This means that
the inner diameter 114 of wall 112 must be less than the minimum
possible outside diameter 115 of wall 116 or less than 3.925 millimeters.
As well, outer diameter 115 of wall 112 must be greater than the
inner diameter 114 of wall 116. Otherwise extension 58 could be
inserted into opening 140 of syringe 110 or opening 142 of syringe
120 (FIGS. 4 and 5 respectively). The inner diameter 114 of wall
116 is not specified in the ANSI/HIMA standard for a typical syringe
as provided above. The minimum outer diameter of wall 112 at end
69 must therefore be estimated based on a reasonable thickness of
wall 116 in order to approximate the largest possible inner diameter
114 of wall 116. Based on a minimum realistic wall thickness of
0.25 millimeters inner diameter 114 of wall 116 can be no more than
3.49 millimeters for a semi-rigid syringe (that is 3.925 minus 0.5
millimeters) or 3.527 millimeters for a rigid syringe (4.027 minus
0.5 millimeters). In order to ensure incompatibility, the outside
diameter 115 of wall 112 must be greater than 3.49 millimeters for
a semi-rigid syringe and greater than 3.527 millimeters for a rigid
syringe. In order to ensure incompatibility with both semi-rigid
and rigid syringes, the outside diameter must be greater than 3.527
millimeters.
FIG. 6 depicts a typical needle 26 adjacent spinal syringe 32 of
the present invention. Needle 26 is a typical slip fit/Luer lock
combination needle used in the medical profession for injection
of drugs. Needle 26 includes circular wall 122 forming opening 124
to receive a drug from a standard slip fit or Luer lock syringe
such as syringe 24 and pass the drug through cannula 126 for injection
into a patient. Wall 122 is of inner diameter 130. Syringe 32 includes
extension 104 with circular wall 128 forming opening 106. Wall 128
is also of inner diameter 130 at outer tip 65 the same as the inner
diameter of wall 122. Syringe 32 may not be operatively connected
to needle 28 as wall 128 and wall 122 being of the same inner diameter,
contact each other preventing operative connection of those components.
That is, outer tip 65 of wall 128 will contact outer end 71 of wall
122 preventing extension 104 from entering opening 124.
A typical needle has an outside lug to lug diameter of between
7.73 millimeters and 7.83 millimeters. In order to ensure that syringe
32 of the present invention may not be operatively connected to
a typical needle 26 inner diameter 130 of wall 128 must be less
than the minimum outer diameter, lug to lug, of wall 122 at tip
71. This means that inner diameter 130 of wall 128 at tip 65 must
be less than 7.73 millimeters.
As well, outer diameter 131 of wall 128 at tip 65 must be greater
than the maximum inner diameter 130 of wall 122 at tip 71. As the
maximum inner diameter 130 of wall 122 is 4.315 millimeters in accordance
with the ANSI/HIMA standard, outer diameter 131 of wall 128 at tip
65 must be greater than 4.315 millimeters.
Referring to FIG. 4 a typical slip-fit syringe 110 has nozzle
109 with circular wall 116 outer diameter 115 at tip 63 of between
about 3.925 millimeters and 3.990 millimeters. Similarly, with reference
to FIG. 5 a typical Luer lock syringe 24 has an extension 59 with
circular wall 118 outer diameter 115 at tip 65 of between about
3.925 millimeters and 3.990 millimeters. In order to prevent operative
connection of a needle 34 to syringe 24 or syringe 110 extension
58 of needle 34 wall 112 outer diameter 115 at outer end 69 must
be greater than inner diameter 114 of syringes 24 and 110. As well,
inner diameter 114 of wall 112 at outer end 69 of syringe 34 must
be less than 3.925 millimeters to prevent the smallest possible
outer diameter nozzle 109 or extension 59 from being inserted into
opening 60.
Referring to FIG. 6 and based on the above ANSI standards, a typical
Luer lock and slip fit needle 26 has wall 122 of inner diameter
130 at outer end 65 of about between 4.270 millimeters and 4.315
millimeters. Consequently in order to prevent operative connection
of needle 26 with syringe 32 of the present invention extension
104 with wall 128 is of outer diameter 131 greater than 4.315 millimeters
in order to prevent extension 104 from entering opening 124. As
well the typical needle has a lug-to-lug outer diameter between
about 7.73 millimeters and 7.83 millimeters.
Extension 104 inner diameter 130 must be less than 7.73 millimeters
(the smallest possible outer lug-to-lug diameter of wall 122) in
order to prevent extension 104 from extending over wall 122 to engage
needle 26. This ensures that neither spinal needle 34 nor spinal
syringe 32 may be operatively connected to a typical Luer lock and
slip fit syringe 24 (FIG. 5) or a typical slip fit syringe 110 (FIG.
4) found in hospitals and other places where drugs are administered
thereby preventing drugs in those syringes from being injected spinally
using spinal needle 34. As well, a typical needle 26 (FIG. 6) found
in hospitals and in other places where drugs are injected typically
used for intravenous injection cannot be operatively connected to
syringe 32 of the present invention thereby preventing inadvertent
injection of the spinal drug in spinal syringe 32 through intravenous
needle 26 intravenously into a patient.
FIG. 7 depicts a system for preventing the inadvertent injection
of a spinal drug intravenously and an intravenous drug spinally
generally at 10. System 10 comprises a kit combining the various
components necessary for preventing inadvertent injection which
components are all located in container 12. Container 12 comprises
hard shell bottom member 14 with soft housing member 16 extending
within a cavity formed in bottom member 14. Bottom member 14 includes
indent 18 about the upper and outer circumference of bottom member
14. Cover 20 is dimensioned to extend over the upper part of bottom
member 14 to cover housing member 16. Cover 20 includes lip 22 which
mates with indent 18 to secure cover 20 to bottom member 14. Cover
20 may be made of clear plastic material so that the components
housed in container 12 may be viewed from outside container 12.
System 10 further includes a standard Luer lock and slip fit combination
syringe 24 with a corresponding slip fit and Luer lock needle 26
which is attachable to syringe 24. Cover 28 extends over needle
26 to protect needle 26 and prevent inadvertent contact with tip
30 of needle 26. Container 12 also includes uniquely dimensioned
slip fit syringe 32 used for spinal injection of a drug. Spinal
needle 34 which mates with syringe 32 is also included in container
12 with a corresponding stylette 36 extending longitudinally through
needle 34. Cover 38 extends over needle 34 to protect needle 34
and prevent inadvertent contact with tip 40 of needle 34. Both needle
34 and needle 26 have hollow openings extending longitudinally therethrough
to permit flow if drugs into a patient. The hollow opening of needle
34 is dimensioned to receive stylette 36 therein.
Syringe 24 and needle 26 are of size and shape typically used in
hospitals and by the medical profession for intravenous injection
of drugs or for other suitable drug injection methods as required
for patient care. Spinal syringe 32 and needle 34 have uniquely
dimensioned engaging extensions and are used solely for spinal injection
of a drug.
Housing member 16 includes a plurality of indented regions to hold
the various components previously described. Indented portion 42
is particularly dimensioned such that cover 28 containing needle
26 may be held in place portion 42.
Similarly indent 44 is dimensioned to hold syringe 24 therein.
Indented portion 46 is dimensioned to hold spinal syringe 32 therein
and indented portion 48 is dimensioned to hold stylette 36 (extending
through needle 34), needle 34 and cover 38 therein.
All the components of system 10 forming the kit may be conveniently
housed within container 12 to be used together for simultaneous
treatment and injection of drugs both spinally using syringe 32
stylette 36 and needle 34 and intravenously using syringe 24 and
needle 26.
Operation
Spinal syringe 32 (FIGS. 1 2 and 6) is intended solely for use
in injecting spinal drugs, and is carefully filled only with a spinal
drug. Indicia (not shown) may be marked on the body of spinal syringe
32 warning individuals filling that syringe that only a drug intended
for spinal injection is to be placed in the storage region 83 of
syringe 32. Syringe 32 filled with a drug intended for spinal injection,
may then be delivered to the patient at the place of injection.
The doctor, or other health care provider cannot attach a typical
needle 26 to syringe 32 due to the incompatible dimensioned as described
earlier, thereby preventing injection of a drug in storage region
82 through a typical needle 26.
Spinal needle 34 which is compatible for operative use with syringe
32 is prepared for insertion into the patient's spinal region by
first inserting stylette 36 into needle 34 as depicted in FIGS.
1 and 3. Wing members 76 are used to accommodate the index and first
finger of the medical practitioner and the thumb is placed on platform
78 in order to guide cannula 54 with stylette 36 inserted therein
so that tip 40 and 70 enter the patient's spinal region where the
drug is to be injected.
Stylette 36 is then removed from needle 34 leaving needle 34 in
position in the patient. Syringe 32 is then attached to needle 34
by friction-fit engagement between outer surface 64 of extension
58 of needle 34 and inner wall 108 of extension 104 of syringe 32
as depicted in FIG. 2. Opening 86 connected to storage area 82
is thereby aligned with and connected to opening 106 of needle 34.
Opening 106 is connected to cannula 54 with tip 40 extending into
the spinal region of the patient.
Plunger 84 is depressed into storage region 82 to force the drug
in storage region 82 through opening 86 opening 106 and cannula
54 into the patient's spinal region. This properly directs the drug
in storage region 82 into the spinal region of the patient.
A drug intended for injection in areas other than the patient's
spinal region, for example those intended strictly for intravenous
injection, cannot inadvertently be connected to needle 34 whether
positioned within the patient for spinal injection with tip 40 in
the spinal region of the patient, or otherwise. This prevents the
inadvertent injection of a drug in a typical syringe 24 into the
spinal region of a patient through spinal needle 34.
Referring to FIG. 7 system 10 would generally be provided to a
medical practitioner in situations where a spinal drug is to be
administered to a patient either concurrently with the administration
of another drug intravenously or in a situation where there may
be a danger of misinjection by confusing drugs in particular syringes
with needles used to inject drugs into specific regions of a patient's
body. If all needles present can be attached to syringes containing
these drugs human error can occur causing drugs to be injected in
an inappropriate manner through the mistaken attachment of a syringe
containing a drug meant to be injected in one manner, such as intravenously,
to a needle used for injection in another manner, such as spinally.
The present invention overcomes this problem by providing a uniquely
dimensioned spinal syringe 32 together with a uniquely dimensioned
spinal needle 34 which is operatively attachable to syringe 32.
As well system 10 includes a typical Luer lock/slip fit combination
syringe 24 and a typical slip fit and Luer lock needle 26 which
may be operatively connected to syringe 24. However, as previously
discussed, syringe 24 may not be operatively connected to needle
34 and syringe 32 may not be operatively connected to needle 26.
In a situation where a patient is to be injected with two different
drugs, one spinally and the other intravenously, the spinal drug
is placed in syringe 32 and the intravenous drug is placed in syringe
24.
For intravenous injection of the intravenous drug syringe 24 is
operatively connected to needle 26 which is inserted into the patient's
vein and the drug injected into that vein in typical fashion by
depressing plunger 84.
Spinal injection of the drug in syringe 32 is undertaken by inserting
stylette 36 into needle 34 as depicted in FIGS. 3 and 7 and pushing
spinal needle into the patent's back region until tip 40 enters
the spinal region of that patient. Stylette 36 is then removed and
spinal syringe 32 then attached to needle 34 while it is still in
this region of the patient. Plunger 84 is then depressed in the
usual manner in order to inject the spinal drug through needle 34
and out tip 40 into the spinal region of that patient. It can be
seen that the drug in syringe 24 cannot be mistakenly injected spinal
into the patient through needle 34 due to the fact that the diameter
of wall 118 of syringe 24 is substantially equal to the diameter
of wall 112 of needle 34 preventing operative connection of those
two components, as depicted in FIG. 5.
Similarly, it is impossible for the drug in syringe 32 to be injected
intravenously through needle 26 as these two components cannot be
operatively connected due to the fact that wall 122 and needle 26
and wall 128 of syringe 32 are the same diameter 130 as depicted
in FIG. 6.
While the present invention has been illustrated by the description
of an embodiment thereof, and while the embodiment has been described
in considerable detail, it is not intended to restrict or in any
way limit the scope of the appended claims to such detail. The invention
in its broader aspects is therefore not limited to the specific
details, representative apparatus and method and illustrative examples
shown and described. Accordingly, departures may be made from such
details without departing from the scope or spirit of Applicant's
general inventive concept. |