U.S. patent application number 10/740223 was filed with the patent office on 2005-06-23 for protective sheath for winged needle with keyhole for releasably retaining tubing and packaging incorporating same.
Invention is credited to Gollobin, Peter.
Application Number | 20050137535 10/740223 |
Document ID | / |
Family ID | 34063606 |
Filed Date | 2005-06-23 |
United States Patent
Application |
20050137535 |
Kind Code |
A1 |
Gollobin, Peter |
June 23, 2005 |
Protective sheath for winged needle with keyhole for releasably
retaining tubing and packaging incorporating same
Abstract
A protective sheath for a winged needle has a hilt with a
keyhole for releasably receiving a length of tubing. Methods of the
invention include forming a U-shaped bend in the tubing and
inserting it into the keyhole prior to packaging.
Inventors: |
Gollobin, Peter; (Mineola,
NY) |
Correspondence
Address: |
Galgano & Burke
Suite 35
300 Rabro Drive
Hauppauge
NY
11788
US
|
Family ID: |
34063606 |
Appl. No.: |
10/740223 |
Filed: |
December 18, 2003 |
Current U.S.
Class: |
604/263 ;
128/919; 604/165.03; 604/177 |
Current CPC
Class: |
A61M 25/002 20130101;
A61M 25/0631 20130101; A61M 25/0637 20130101 |
Class at
Publication: |
604/263 ;
604/165.03; 604/177; 128/919 |
International
Class: |
A61M 005/32 |
Claims
1. A winged needle set, comprising: a winged needle, a length of
flexible tubing having first and second ends, said first end
coupled to said needle, and a protective sheath slidably disposed
on said tubing, said sheath having a hilt, said hilt having a
keyhole dimensioned to releasably retain said tubing.
2. A winged needle set according to claim 1, additionally including
a connector coupled to said second end of said flexible tubing.
3. A winged needle set according to claim 1, wherein: said hilt has
two keyholes, each on opposite sides of said hilt.
4. A winged needle set according to claim 1, wherein: said sheath
comprising a hollow generally tubular body having a forward end
oriented toward the needle and a rearward end oriented away from
the needle, said body having at least two fingers defining slots
through which said flexible wings slide.
5. A winged needle set according to claim 4, wherein: at least one
of said wings slides into a locked position.
6. A winged needle set according to claim 4, wherein: said tubular
body has four fingers and four slots, each of said slots being
provided with a Z-bend.
7. A winged needle set according to claim 4, wherein: the forward
end of said fingers are V-shaped and tapered to facilitate the
passage of said wings into the slots.
8. A winged needle set according to claim 1, wherein: said sheath
includes means for locking the sheath in a position covering the
needle to prevent needlesticks from the needle.
9. A method of packaging a flexible tubing coupled to a winged
needle having a protective sheath slidably mounted on said tubing
having a hilt with a keyhole, comprising the steps of: forming a
U-shaped bend in the length of flexible tubing, and inserting a
section of the flexible tubing into the keyhole of the protective
sheath so as to maintain the U-shaped bend.
10. The method according to claim 9, wherein said U-shaped bend is
formed at the approximate midpoint of the tubing.
11. The method according to claim 10, further comprising the step
of positioning said sheath adjacent to said U-shaped bend.
12. The method according to claim 10, further comprising the step
of placing the tubing, needle, and sheath into a package.
13. The method according to claim 12, further comprising: sealing
the package.
14. A protective sheath for a winged needle, said sheath
comprising: a hollow generally tubular body having a forward end
oriented toward the needle and a rearward end oriented away from
the needle, said body having at least two fingers defining slots,
and a hilt at the rearward end of said body, said hilt defining at
least one keyhole adapted to releasably receive a length of
flexible tubing.
15. A sheath according to claim 14, wherein said sheath has means
for locking said winged needle within said tubular body of said
sheath.
16. A sheath according to claim 14, wherein: said tubular body has
four fingers and four slots, each of said slots being provided with
a Z-shaped bend.
17. A sheath according to claim 14, wherein: the forward end of
said fingers are V-shaped and tapered to facilitate the passage of
said wings into the slots.
18. A sheath according to claim 14, wherein: said sheath includes
means for locking the sheath in a position covering the needle to
prevent needlesticks from the needle.
19. A sheath according to claim 14, wherein: said tubing is made of
medical grade plastic tubing.
Description
[0001] This application is related to co-owned U.S. Pat. No.
5,330,438, and published application number 20020188260, the
complete disclosures of which are hereby incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a protective sheath or
safety guard for winged needles and, in particular, to a protective
sheath having a keyhole for releasably retaining the flexible
tubing of a winged needle set and a method of packaging a winged
needle set having such a protective sheath.
[0004] 2. State of the Art
[0005] A well known winged needle (also known as a butterfly
needle) assembly is shown in prior art FIG. 1. The assembly 10
includes a needle 12 having a pair of wings 14, coupled to a first
end of a length of coiled flexible tubing 16, and a coupling
attached to the rear end of the tubing by which this winged needle
set or assembly may be attached to, e.g., means for piercing a
vacuum bottle for blood collecting or a Luer lock tapered coupling
for IV tubing. The winged needle assembly has been used for many
years in, e.g., the administration of IV medications and in
obtaining blood samples when use in conjunction with vacuum
bottles. The purpose of the assembly is to limit trauma to the
patient's blood vessel(s), particularly when multiple samples of
blood are to be taken or when multiple types of medication are to
be administered. After the needle is inserted into the patient's
blood vessel, the wings are taped to the patient's body to prevent
movement of the needle when coupling/uncoupling the Luer lock or
attaching or disconnecting the vacuum bottle used for blood
collecting. Any movement of the needle can cause trauma of the
patient's blood vessel. The winged needle assemblies are typically
packaged with the flexible tubing wound in a coil such as
illustrated in FIG. 1, typically coiled in several loops. It has
recently been discovered by the inventor herein that when a winged
needle kit is packaged with the tubing coiled, the tubing tends to
retain a coiled configuration even after it is unpackaged. It has
also been discovered by the inventor herein that when the flexible
tubing has retained a coiled configuration, even a slight movement
of one end of the tubing will disadvantageously cause immediate
movement of the other end.
[0006] In the 1980s after the discovery of the HIV virus which
causes AIDS, much attention was given to the problem of accidental
needlesticks from contaminated medical equipment such as syringes
and IV equipment which poses serious risks to healthcare
professionals. Even maintenance personnel who dispose of the used
medical equipment are at risk. Hepatitis, AIDS and other diseases
can be, and sometimes are, transmitted by accidental needlesticks
from needles used on infected patients.
[0007] My prior U.S. Pat. No. 5,330,438 discloses an improved
sheath construction (shown in prior art FIG. 2) which significantly
minimizes the possibility of improper operation and jamming of the
used needle relative to the sheath during the sheathing operation.
The IV infusion set 20 includes an IV tube 22, a hollow needle 24
coupled to one end of the tube and two wings 26 adjacent the needle
24. A Luer connector (not shown) is connected to the other end of
the IV tube. The IV infusion set 20 also includes a sheath 28
slidably disposed on tube 22. The sheath 28 is adapted to be slid
past the flexible wings 26 to cover the needle after the needle has
been used.
[0008] The sheath 28 preferably includes a knurled, generally
cylindrical, annular base 29 by which the sheath may be easily
grasped. Base 29 has a central bore (not shown) through which tube
22 may slidably pass and is integrally joined to a hollow generally
tubular body 30 having a forward end 32 oriented toward the needle
24 and a rearward end 34 oriented away from the needle. The body 30
preferably has four fingers 35 separated by four longitudinally
extending slots 36 extending from the forward end or tip 32 of body
30 to the rearward end 34. The slots 36 are each adapted to receive
only one of the wings 26 to allow at least part of the sheath 28 to
be slid past the wings 26 to cover the needle 24.
[0009] The body 30 also includes cutouts 42 at the rearward end of
the slots 36, adapted to receive and engage the wings 26 to lock
the sheath in its position covering the needle. The cutouts 42 have
a width approximately equal to the width of one of the wings 26.
Slot 36 is slightly narrower than the thickness of the wings. As a
result, as the wings 26 pass through the slots 36, the fingers 35
will resiliently wedge apart, and upon passage of the wings 26 into
the wider cutouts 42, snap back and assume their normal position,
thereby trapping the wings 26 in the cutouts 42 behind the forward
edges 44 of the cutouts. This prevents the needle 24 from sliding
forwardly out of the sheath 28.
[0010] Recently, the U.S. Food and Drug Administration has
requested that all safety devices used with needles either change
color or produce an audible sound or provide some other easy to
recognize evidence that the needle has been rendered safe. My prior
application 20020188260 addresses that concern and provides other
improvements.
[0011] FIGS. 3 and 4 illustrate the needle sheath of said published
application. The sheath 128 is provided in conjunction with a
hollow needle 1 24 with a pair of wings 126. The sheath 128
includes at least a pair of fingers 132, 140 extending from an
annular base 130. (FIG. 4 illustrates an embodiment 128' with four
fingers 132', 133, 140', 141). The fingers define a pair of slots
142 through which the wings 126 of the needle 124 may slide. The
slots define an open end 146 and a closed end 154. The slots 142
are provided with a Z-bend 153, 155. The Z-bend is dimensioned such
that the wings 126 can pass through it with some deformation, and
an audible click is heard as the wings and/or fingers cease to be
deformed. As seen in FIG. 3, the fingers 132, 140 terminate in a
first annular structure 138 which is separated from the annular
base 130 by a hilt 134. As shown in FIG. 3, the hilt 134 has two
angled ends 150, 152, although the angled ends may be omitted as
shown in FIG. 4 at 134'. The hilt 134 assists in holding the sheath
while sliding the sheath and of the wings into the locked position
shown in FIG. 3.
SUMMARY OF THE INVENTION
[0012] Accordingly, it is an object of the present invention to
overcome the disadvantages imposed by packaging a winged needle and
tube assembly with the tubing coiled.
[0013] It is a further object of the present invention to include
the advantages of my prior inventions.
[0014] The foregoing and related objects are readily achieved in a
winged needle and tube assembly of the type including a length of
flexible tube with a hollow needle at one end, and a pair of
outwardly projecting flexible wings adjacent the end of the tubing
with the needle and a sheath slidably disposed on the tube and
adapted to be slid over the needle to cover the needle after use.
The sheath comprises a hollow generally tubular body having a
forward end oriented toward the needle and a rearward end oriented
away from the needle. The body has at least two longitudinally
extending fingers separated by slots extending from the forward end
of the body toward the rearward end, each of the slots being
dimensioned to receive only one of the wings to allow at least part
of said sheath to be slid past the wings to cover the needle. The
sheath is provided with a hilt which facilitates the sliding of the
sheath and/or wings into a locked position where the sheath covers
the needle. According to the invention, the hilt is provided with
at least one keyhole for removably securing the flexible
tubing.
[0015] Certain of the foregoing and related objects are attained
according to the invention by the provision of a winged needle set,
comprising a winged needle, a length of flexible tubing having
first and second ends, said first end coupled to said needle, and a
protective sheath slidably disposed on said tubing, said sheath
having a hilt with said hilt having a keyhole dimensioned to
releasably retain said tubing. Preferably, the winged needle set
additionally includes a connector coupled to said second end of
said flexible tubing and said hilt has two keyholes, each on
opposite sides of said hilt.
[0016] Advantageously, the sheath comprises a hollow generally
tubular body having a forward end oriented toward the needle and a
rearward end oriented away from the needle with said body having at
least two fingers defining slots through which said flexible wings
slide. Most desirably, at least one of said wings slides into a
locked position. The tubular body preferably has four fingers and
four slots, each of said slots being provided with a Z-bend and the
forward end of said fingers are V-shaped and tapered to facilitate
the passage of said wings into the slots. Most advantageously, the
sheath includes means for locking the sheath in a position covering
the needle to prevent needlesticks from the needle.
[0017] Certain of the foregoing and related objects are also
attained in a method of packaging a flexible tubing coupled to a
winged needle having a protective sheath slidably mounted on said
tubing having a hilt with a keyhole, comprising the steps of:
forming a U-shaped bend in the length of flexible tubing, and
inserting a section of the flexible tubing into the keyhole of the
protective sheath so as to maintain the U-shaped bend. Most
advantageously, the U-shaped bend is formed at the approximate
midpoint of the tubing. Preferably, the method involves the further
steps of positioning said sheath adjacent to said U-shaped bend,
placing the tubing, needle, and sheath into a package, and sealing
the package.
[0018] Certain of the foregoing and related objects are also
attained in a protective sheath for a winged needle according to
the invention which sheath comprises a hollow generally tubular
body having a forward end oriented toward the needle and a rearward
end oriented away from the needle, said body having at least two
fingers defining slots, and a hilt at the rearward end of said
body, said hilt defining at least one keyhole adapted to releasably
receive a length of flexible tubing. Preferable, the sheath has
means for locking said winged needle within said tubular body of
said sheath and said tubular body has four fingers and four slots,
each of said slots being provided with a Z-shaped bend.
[0019] In a preferred embodiment of the invention, the forward end
of said fingers are V-shaped and tapered to facilitate the passage
of said wings into the slots and said sheath includes means for
locking the sheath in a position covering the needle to prevent
needlesticks from the needle. The tubing is preferably made of
medical grade plastic tubing,
[0020] The invention is based on two discoveries, the first being
the recognition of a problem not previously recognized, i.e., that
the coiled shape retained by flexible medical tubing (e.g., IV
tubing) which is coiled in its package causes the ends of the
tubing to be mechanically responsive to each other. Movement of one
end of a coiled IV tube causes immediate movement of the other end.
The second discovery is that when the flexible tubing is packaged
with only a single U-shaped bend, it retains its flexibility so
that relatively large movement of one end has very little effect on
the other end, i.e., movement of one end doesn't cause appreciable
movement of the other end. This, in turn, reduces possible trauma
to the injection site (patient's blood vessel) caused by movement
of the needle.
[0021] Additional objects and advantages of the invention will
become apparent to those skilled in the art upon reference to the
detailed description taken in conjunction with the provided
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a plan view of a conventional IV infusion set
having a winged needle;
[0023] FIG. 2 is a perspective view of a winged needle and
protective sheath according to my prior patent;
[0024] FIG. 3 is a side elevation view of a sheath according to my
previously incorporated published application with the wings of a
winged needle beyond the Z-bend in the slot of the sheath and thus
in a locked position;
[0025] FIG. 4 is an end view of a sheath according to my previously
incorporated published application with a slightly different shaped
hilt;
[0026] FIG. 5 is a view similar to FIG. 4 but illustrating the hilt
according to the present invention; and
[0027] FIG. 6 is a plan view of a winged needle set according to
the invention illustrating a method of using the hilt keyhole and a
method of packaging the set.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0028] Referring now to FIGS. 5 and 6, a winged needle set 200
according to the invention is shown which can be used in the
medical field as, e.g., an IV infusion or blood collecting set. The
winged needle set 200 includes a needle 202 having a pair of wings
204, and a length of medical grade, plastic flexible tubing 206.
The tubing 206 has a first end 208 which is coupled to the needle
202 and a second end 210 which is typically coupled to a connector
212, e.g., a Luer lock tapered coupling for IV tubing or a threaded
connector coupled to a needle for piercing a blood-collecting
bottle. A protective sheath 214 having a hilt 216 is slidably
disposed on the tubing 206. According to the present invention, the
hilt 216 is provided with a first keyhole 218, and preferably also
a second keyhole 220 as illustrated in FIG. 5. The characteristics
of the winged needle set 200, other than the keyholes, are
substantially the same as described in my previously incorporated
published application.
[0029] According to methods of the invention, the flexible tubing
206 is bent approximately in half to define a U-shaped bend 222 and
the sheath 214 is moved or shifted along tubing 206 to a position
adjacent to the U-shaped bend 222. A portion or section of the
tubing 206 adjacent the U-shaped bend 222 is inserted into one of
the keyholes, e.g., 218 as shown in FIG. 6. This maintains the
tubing with this U-shaped bend 222 at a location approximately
midway between the first end 208 and the second end 210 of the
tubing 206. Due to the size of the hilt, this bend 222 has a
relatively small diameter. With the winged needle set 200 so
configured, it is placed in a substantially rectangular package
224. The package may be made of any suitable sterile barrier
material.
[0030] By pushing the flexible tubing into the keyhole before
packaging, it forces the originally straight tubing to remain in a
U-shape consisting of two straight lengths and one small diameter
bend 222 at the approximate midpoint of the tubing 206. When the
flexible tubing 206 is forced to remain in the same shape for a
prolonged period of time, especially during the conditions of most
sterility processes, it tends to retain most of the shape.
Therefore, when the winged needle set 200 is removed from its
package 224, and the flexible tubing 206 is pulled free from the
keyhole 218, the flexible tubing 206 will remain with the shape of
two straight lengths and one small diameter bend 222 at the
approximate midpoint of the tubing 206.
[0031] The keyhole provides a fast, easy, and inexpensive method to
produce the above-described U-shape in the tubing. It also changes
the entire assembly into a long thin shape rather than a short fat
coil shape. This long thin shape is easy to handle with standard
packaging machinery. Most brands of winged needle sets are coiled
and slid into a separate plastic sleeve to hold it in a workable
shape so that it can be easily handled and transferred into
standard packaging machines. The present invention reduces the cost
of packaging because: there is no need to coil the tubing; there is
no need to purchase and cut-to-length plastic sleeving; and there
is no need to place the coiled tubing into a plastic sleeve prior
to packaging.
[0032] According to the present invention, the tubing is quickly
snapped into the keyhole on either side of the hilt, giving the
tubing a workable "U" shape which can then easily be placed into a
packaging machine or directly into the package.
[0033] There has been described and illustrated herein a protective
sheath for butterfly or winged needles, a winged needle set, and
methods for packaging the set. While particular embodiments of the
invention have been described, it is not intended that the
invention be limited thereto, as it is intended that the invention
be as broad in scope as the art will allow and that the
specification be read likewise. It will therefore be appreciated by
those skilled in the art that yet other modifications could be made
to the provided invention without deviating from its spirit and
scope as so claimed.
* * * * *