WO1998031407A1

WO1998031407A1 - Needle apparatus

Info

Publication number: WO1998031407A1
Application number: PCT/US1997/000689
Authority: WO
Inventors: Noshi A. Ishak
Original assignee: Ishak Noshi A
Priority date: 1997-01-22
Filing date: 1997-01-22
Publication date: 1998-07-23
Also published as: AU1830297A; EP1005380A1; EP1005380A4

Abstract

This invention is a needle apparatus (10) for intravenous applications which helps prevent needlesticks. The invention includes a needle housing (22) to which a standard hypodermic needle (27) is attached. The needle housing (22) can then be attached to standard syringes via a base (21). A protective housing (23) surrounds the needle housing (22) which provides two locking positions with the protective housing (23) extended over the needle (27). The first is 'temporary' which can be removed to restore the needle (27) but still encases the needle (27) protecting medical personnel from a needlestick. The second is 'locked' where the needle (27) cannot be re-exposed, again protecting medical personnel. The protective housing (23) is fitted with a Luer lock (26) so that the apparatus (10) can be used to connect to an I.V. line without requiring the removal of the needle (27).

Description

NEEDLE APPARATUS

BACKGROUND OF THE INVENTION

1 . Field of the Invention

The invention relates to needles for intravenous applications.

2. Description of the Related Art

Each year, the number of individuals who are infected with Human

Immune-deficiency Virus (HIV), Hepatitis B (HPV), and other dangerous diseases

is increasing. Currently, the Center for Disease Control (CDC) estimates that

from 1.5 - 2 million people in the United States are infected with HIV. Many of

these HIV cases are undiagnosed, which makes anyone who comes in contact

with the infected person's body fluids vulnerable to HIV infection as well. Nurses

and doctors are particularly vulnerable to HIV infection because their work

involves working closely with the body fluids of their patients.

One significant source of HIV exposures for health care workers is

accidental needlesticks. The number of accidental needlesticks is estimated to

be more than one million per year. Of these, roughly 2% are contaminated by

HIV. To make matters worse, about 50% of HIV needlesticks go unreported.

The significance of this problem is borne out by the fact that 80% of HIV

exposures to health care workers are caused by needlesticks. Of these

needlesticks, one in 200 results in an HIV infection. The CDC also estimates that

12,000 health care workers in the United States will become infected with HPV

each year. Over 80% of those HPV infections acquired occupationally by health care workers will be as a result of needlesticks or other sharp instruments. Of

those infected, over 200 will die. Clearly, there is a vital need for reducing the

occurrence of this type of accident.

Studies reveal that more that 75% of needlesticks occur after use of the

needle, in preparation for, or during disposal. Yet despite special precautions

such as the use of containers for needles to be discarded and educational

programs for health workers, the incidence of needlesticks has not been

significantly reduced. Many experts predict that this situation will not change until

needles of safer design are introduced.

A common needle design for injections has the needle permanently affixed

to the syringe. The disadvantage of this approach is that the syringe does not

contain a means of protecting the worker from a needlestick, thus, risking

exposure to the health care worker.

Attempts have been made to provide a syringe which allows the needle

to be covered by a protective shield. A typical example of this type of apparatus

is the B-D Safety -Lokό syringe marketed by Becton Dickinson and Company.

This device has a protective shield that slides over the used needle for preventing

contact. However, to protect the needle, such devices, including the B-D Safety

-Lokό design, require that the entire syringe and needle be discarded together.

While effective, this approach is more cumbersome because needlesticks are the

contributing factor for infection of health care workers, not the syringe itself.

An alternative method to preventing needlesticks is the Needle Proό design marketed by Concord/Portex, Smith Industries. This design is covered

under U.S. Patent No. 4,982,842 which discloses a self contained needle with a

protective sheath attached. After use of the needle with a syringe, the

permanently attached sheath is positioned over the needle so that the needle

may be discarded separately from the syringe.

The protective feature of the Needle Proό device utilizes a sheath that

freely hangs on the side of the needle. However, this sheath can be a distraction

when the needle is used in intravenous applications. Also, the device is not

adaptable with needleless systems. Furthermore, there is additional dead space

by having two needle bases on top of each other. This leads to more waste of

the medication and to patients receiving less than the prescribed dosage due to

retention of medication by the base surfaces.

As stated earlier, typical needle designs for intravenous applications have

the needle affixed to the syringe. If it is desired to use the syringe by connecting

it to an I.V. line, the needle must first be removed. Hence, devices that have

protective features as part of the syringe will not be utilized, thus presenting the

opportunity for an accidental needlestick. With needles that are permanently

affixed to the syringe, this means that needle and syringe must both be

discarded. When repeated medications are required, a new syringe must be

used each time.

A device for injections that provides a needle apparatus that can be mated

to needleless syringes and can be connected to an I.V. line without removing the needle and without presenting a danger of needlesticks, even when the needle

is removed from the syringe, is not disclosed in the prior art.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a needle apparatus which can be

connected to a needleless syringe which can then be used to withdraw

medications or give injections.

It is another object of the invention to provide a needle apparatus which

completely encloses the needle after use so it cannot produce a needlestick.

It is another object of the invention to provide a needle apparatus which

"locks" the needle within the needle apparatus so that it can be connected to an

I.V. line without removing the needle or be safely discarded if already used.

It is another object of the invention to provide a needle apparatus which

"temporary locks" the needle within the needle apparatus after medication has

been withdrawn but can re-expose the needle for injecting the medication into the

patient or I.V. line.

It is another object of the invention to provide a needle apparatus which

utilizes a color coding scheme to allow easy visual verification on the positioning

of needle apparatus in the "locking" or "temporary locking" position.

It is a final object of the invention to provide a needle apparatus which can

be used to connect to needleless ports of I.V. lines to administer medications

without requiring the removal of the needle.

The invention is a needle apparatus for injection and intravenous medical procedures. A needle is provided that is adapted to inject or withdraw fluids. A

needle housing is provided that has a base that is attachable to a standard

syringe. Said needle housing has an elongated nose section that permanently

holds said needle. Said nose section has an exterior cross-sectional profile and

has a tip. A protective housing is provided that has a needle opening

corresponding to said needle. Said protective housing also has a recess, said

recess having an interior cross-sectional profile corresponding to said exterior

cross-sectional profile of said nose section. Locking means, associated with said

protective housing and said needle housing, are provided for holding said

protective housing in a "fixed extended position" relative to said needle housing

such that when said protective housing is in the "fixed extended position", the

point of said needle is held within the interior walls of said outer housing.

Temporary locking means, associated with said protective housing and said

needle housing, are also provided for holding said protective housing in a

"temporary extended position" relative to said needle housing such that when

said protective housing is in the "temporary extended position", the point of said

needle can be re-exposed. The nose of said needle housing has color bands to

allow easy visual verification of the position of said needle protective housing in

either the "temporary extended position" or the "fixed extended position".

Connection means, attached to said protective housing, are provided for

connecting said apparatus to an I.V. line when said protective housing is in the

fixed extended position, without removing said needle from said apparatus. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a longitudinal cut-away view of the needle apparatus, showing

the needle before use in accordance with the invention.

Figure 2 is a longitudinal cut-away view of the needle apparatus, showing

the protective guard housing partially advanced in the "temporary extended

position" to protect the needle.

Figure 3 is a longitudinal cut-away view of the needle apparatus, showing

the protective guard housing fully advanced in the "fixed extended position" to

protect the needle.

Figure 4A is a detailed longitudinal cut-away view of the locking

mechanism that holds the apparatus in the protected position.

Figure 4B is a detailed longitudinal cut-away view of an alternative

embodiment of the locking mechanism shown in Fig. 4A.

Figure 4C is a detailed longitudinal cut-away view of another alternative

embodiment of the locking mechanism shown in Fig. 4A.

Figure 5A is a cross-sectional view of the needle protective guard over the

needle base along section lines AA as shown in Fig. 1 .

Figure 5B is a cross-sectional view of an alternate embodiment of the

needle protective guard over the needle base along section lines AA as shown

in Fig. 1 .

Figure 6 is a longitudinal cut-away view of an alternative embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to Figs. 1 -3, needle apparatus 10 with needle 27 is shown

in the ready-to-use, unprotected position; with the guard housing partially

extended to protect the needle; and with the guard housing fully extended, in the

locked position. In the locked position, needle apparatus 10 can be connected

to an I.V. line (not shown) via Luer lock 26 without removing the needle or can

be safely discarded if already used. The materials selected for the construction

of the invention are preferably plastics, well known in the art for constructing such

medical devices.

The external shape of the invention, including housings 22 and 23, are

preferably oval but other cross-sectional shapes would be acceptable. Fig. 5A

is a cross-sectional view of protective housing 23 over needle base 22. The oval

cross-section allows for a firmer grip because it prevents rotation of protective

guard 23 over needle housing 22. Fig. 5B is an alternative embodiment of

invention 10 using a circular cross-section. Manufacture can be performed in a

number of ways, however, the most practical from a cost and quantity

perspective is injection molding.

Referring again to Figs. 1 - 3, needle 27 is rigidly attached to needle

housing 22. Needle 27 is preferably constructed of medical grade stainless or

other materials that have been approved for needle use. Needle 27 is attached

using techniques well known in the art, such as electro-welding. By extending the length of needle 27, insertion into needle housing 22 can extend all the way

through to point 7 if so desired. At the "syringe" end of needle housing 22,

needle housing 22 is flared to provide attachment base 21. Flange 15 is

provided at the end of base 21 and serves to releasably attach invention 10 to a

standard hypodermic syringe (not shown). Nose 20 of needle housing 22 is

preferably about 1 inch long and is sized according to the length of protection

housing 23 which is mated to nose 20. In turn, protective housing 23 must be

sufficiently long to completely enclose needle 27 when the device is in a

protective position as shown in Figs. 2 and 3. Consequently, to accommodate

different lengths of needles, the lengths of protective housing 23 and needle

housing 22 may have to be adjusted accordingly.

When invention 10 is attached to a standard syringe, invention 10 and the

attached syringe can be used to withdraw medication fluids or administer

injections via needle 27.

Figure 2 is a longitudinal cut-away view of needle apparatus 10, showing

protective housing 23 partially advanced in the "temporary extended position" to

protect needle 27. Protective housing 23 is positioned in temporary locking

groove 60. Temporary locking groove 60 is symmetrical around nose 20. If the

needle is not yet ready to be discarded but in need of protection, protective

housing 23 is advanced until locking ridge 35 is engaged with temporary locking

groove 60. Either one "click" sound or by feel of the restraint placed upon

protective housing 23 will provide medical personnel feedback that needle apparatus 10 is in the temporary locking position. A useful application of this

feature is to protect needle 27 after medication has been withdrawn while

allowing needle 27 to be re-exposed to inject medication into a patient or to be

used with an I.V. line.

Needle 27 can be protected in two different positions. One is with

protective housing 23 being retained by temporary locking groove 60, as

discussed in the previous paragraph. The other position is when protective

housing 23 is fully extended in the locked position. Figure 3 is a longitudinal cut¬

away view of needle apparatus 10, showing protective guard housing 23 fully

advanced in the "fixed extended position" to protect needle 27.

To provide a means for visual verification on the positioning of protective

housing 23, nose 20 has three color bands, as shown in Fig. 4A. The color

bands are red 82, orange 81 and green 80. The method for colorized plastic is

well known in the art. Size of the color bands are selected such that when

protective housing 23 is in the temporary locking position, only red 82 and orange

81 color bands are visible. For the locked position of protective housing 23, the

green 80 color band is also visible with the red 82 and orange 81 color bands.

Locking groove 25 is symmetrical around tapered tip 17 of needle housing

22. Tapered tip 17 allows easier assembly of protective housing 23 over needle

27 and needle housing 22. Locking groove 25 is circumferentially notched so

protective housing 23 can be held in position. As shown in Figure 3, once needle 27 has been used and protective housing 23 is fully extended, needle 27 is

entirely enclosed within protective housing 23, thereby preventing a user from

being injured by needle 27.

As shown in Fig. 4A, locking groove 25 is preferably shaped with vertical

ridges, as indicated by surfaces 46 and 47. In order to permit installation of

protective housing 23 past locking groove 25, protective housing 23 is heated to

a sufficient temperature during the assembly process so that the elastic

properties of the plastic allow enough of a gap for installation of protective

housing 23 past locking groove 25. An alternative method of installation would

require protective housing 23 to consist of two halves that are welded or sealed

together after they are positioned in place. Both installation methods are well

known in the art.

After needle 27 has been used and protective housing 23 has been fully

extended, surface 46 on needle housing 22 butts up against surface 44 on

protective housing 22 to stop needle housing 22 from being moved past locking

groove 25. At this point, slidable outer protective housing 23 is permanently

locked in place and needle 27 becomes enclosed with no exposed sharp points,

ready for disposal. To prevent protective housing 23 from being pulled off needle

housing 22 once needle housing 22 is inserted into protective housing 23,

surface 47 on needle housing 22 butts up against surface 49 on protective

housing 23 to stop needle housing 22 from being removed past locking groove

25. As an alternative embodiment, as shown in Fig. 4B, locking groove 25 is

shaped with an upwardly sloped ramp surface 46'. This facilitates needle

housing 22 sliding over locking ridge 35 which has a similarly sloped ramp on

surface 44. To prevent protective housing 23 from being removed from needle

housing 22 once needle housing 22 is inserted into protective housing 23,

surface 47' on needle housing 22 and surface 49' on protective housing 23 stop

needle housing 22 from being removed past locking groove 25. Further security

to prevent needle housing 22 from being retracted can be provided by optional

ridge 97, shown in dotted lines.

As another alternative embodiment, as shown in Fig. 4C, surfaces 47" and

49" may also be made with upwardly sloping ramps which will provide a more

positive locking position once protective housing 23 is slid into the "needle

protected" position. As above, to provide additional security to prevent needle

housing 23 being retracted, optional ridge 97, shown by dotted lines, can be

utilized.

To retain protective housing 23 in place and prevent it from sliding on

needle housing 22 while needle 27 is exposed, needle base 22 may be fitted with

ridge 53 which will keep the respective housings in position in the "needle use"

mode. Ridge 53 is preferably a small rounded section that is molded into needle

housing 22. Ridge 53 does not "lock" protective housing 23 in position, but

merely serves as a temporary point of stability.

To facilitate sliding protective housing 23 into position, knurled surfaces 72 and 73 can also be molded into protective housing 23. Surfaces 72 and 73

will enable a user to have a more firm grip on protective housing 23 in order to

slide it more securely.

Protective housing 23 is of substantially hollow construction and is fitted

with recess 11 which corresponds to the cross-sectional profile of nose 20 of

needle housing 22. Needle housing 22 is also of substantially hollow

construction and is fitted with recess 110 which corresponds to the cross-

sectional profile of needle 27.

As shown in Figure 3, once protective housing 23 is fully extended and

locked via locking ridge 35 and groove 25, needle 27, including the tip of needle

27, is completely enclosed. When protective housing 23 is full retracted, locking

ridge 35 rests on attachment base 21 as shown in Fig. 1. Once locked in place,

the length of protective housing 23 must extend past the tip of needle 27, as

shown in Figures 2 and 3 in order to provide protection from needlesticks.

Protective housing 23 is supplied with Luer lock 26, as shown in Figures 1 , 2 and

3. Luer lock 26 allows the needle apparatus to be connected or secured to an

I.V. line without removing the needle. This saves a substantial amount of time,

avoids wasting syringes and prevents needlesticks.

Figure 6 is a view of an alternative embodiment of invention 10. In this

embodiment, protective housing 23 is designed as a standard syringe tip without

Luer lock 26. As in the preferred embodiment, the operator is prevented from a

needlestick since needle 27 is completely enclosed by protective housing 23 when protective housing 23 is locked into place on needle housing 22.

To use needle apparatus 10, a syringe (not shown) is first inserted into

attachment base 21. Outer protective housing 23 is in a retracted position, thus

exposing needle 27 as shown in Figure 1. The operator is ready to use needle

27 to withdraw medications or give injections. Once needle 27 has been used,

the operator grabs attachment base 21 with one hand and protective housing 23,

preferably at knurled surfaces 72 and 73, with the other hand and fully extends

protective housing 23 to enclose needle 27. Protective housing 23 is pushed

toward needle 27 tip until locking ridge 35 snaps into place with temporary

locking groove 60. Protective housing 23 can continue to be pushed toward

needle 27 tip until locking ridge 35 snaps into place with locking groove 25. At

this point, slidable outer protective housing 23 is securely locked in place as

indicated by all three color bands showing and needle 27 becomes totally

enclosed with no exposed sharp points, ready for disposal.

As an alternative use of needle apparatus 10, connection can be made to

needleless ports of I.V. lines to administer medications without the need to

remove needle 27. A syringe is merely inserted into attachment base 21 when

medication is needed to be administered. Once needle 27 is removed, it can be

completely enclosed and securely locked within protective housing 23 for

disposal.

While there have been described what are at present considered to be the

preferred embodiments of this invention, it will be obvious to those skilled in the art that various changes and modifications may be made therein without

departing from the invention and it is, therefore, aimed to cover all such changes

and modifications as fall within the true spirit and scope of the invention.

Claims

What is claimed:

1. A needle apparatus for intravenous medical procedures comprising:

a needle adapted to inject or withdraw fluids;

a needle housing with a base that is attachable to a standard syringe, said

needle housing having an elongated nose section that permanently holds said

needle, said nose section having an exterior cross-sectional profile and having

a tip;

a protective housing having a needle opening corresponding to said

needle, and a recess, said recess having an interior cross-sectional profile

corresponding to said exterior cross-sectional profile of said nose section, such

that when said protective housing is at least partially retracted, the tip of said

needle is unprotected.

locking means, associated with said protective housing and said needle

housing, for holding said protective housing in an extended position relative to

said needle housing such that when said protective housing is in said extended

position, the point of said needle is held within the interior walls of said outer

housing, said locking means further comprising:

a locking ridge protruding circumferentially from said recess of said

protective housing and a locking groove circumferentially adjacent to said tip of

said nose section of said needle housing such that when locking ridge engages

said locking groove, said protective housing cannot be removed from said needle

housing, such that when said protective housing is so disposed relative to said protective housing, said extended position is locked; and

a temporary locking ridge protruding circumferentially from said recess of

said protective housing and a locking groove circumferentially adjacent to said

tip of said nose section of said needle housing such that when temporary locking

ridge engages said locking groove, said protective housing can be pulled back

to re-expose said needle, such that when said protective housing is so disposed

relative to said protective housing, said extended position is releasable.

2. The apparatus of claim 1 wherein said needle housing further comprises

color bands to allow easy visual verification of the position status of said

protective housing relative to said needle housing.

3. The apparatus of claim 2 where the color red on said needle housing

is used to indicate at least a partially retracted position; the color orange is used

to indicate the extended position that is releasable; and the color green is used

to indicate the extended position that is locked.

4. The apparatus of claim 3 further comprising:

connection means, attached to said protective housing, for connecting said

apparatus to an I.V. line when said protective housing is in the extended position,

without removing said needle from said apparatus.

5. The apparatus of claim 4 wherein said protective housing further

comprises at least one textured surface such that a user can more easily slide

said protective housing to the fixed extended position.

6. The apparatus of claim 5 further comprising retaining means for releasably holding said protective housing in a fully retracted position relative to

said needle housing such that when said protective housing is in the fully

retracted position, said needle is outside of said protective housing, ready for use

to inject or withdraw fluids.

7. The apparatus of claim 6 wherein said retaining means further

comprises a retaining ridge protruding circumferentially from said recess of said

protective housing adjacent to said needle opening such that when said

protective housing is in the fully retracted position, said retaining ridge releasably

engages said locking groove, thereby releasably holding said protective housing

in the fully retracted position.