WO2001028611A2 - Hypodermic needle protective cover - Google Patents

Hypodermic needle protective cover Download PDF

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Publication number
WO2001028611A2
WO2001028611A2 PCT/AU2000/001252 AU0001252W WO0128611A2 WO 2001028611 A2 WO2001028611 A2 WO 2001028611A2 AU 0001252 W AU0001252 W AU 0001252W WO 0128611 A2 WO0128611 A2 WO 0128611A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
spring
sheath
cover
latex
Prior art date
Application number
PCT/AU2000/001252
Other languages
French (fr)
Other versions
WO2001028611A3 (en
Inventor
Dennis F. Burley
Peter D. Burley
Original Assignee
Burley Dennis F
Burley Peter D
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Burley Dennis F, Burley Peter D filed Critical Burley Dennis F
Priority to AU10072/01A priority Critical patent/AU780560B2/en
Publication of WO2001028611A2 publication Critical patent/WO2001028611A2/en
Publication of WO2001028611A3 publication Critical patent/WO2001028611A3/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/20—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/14—Dipping a core
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/56—Stoppers or lids for bottles, jars, or the like, e.g. closures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7544—Injection needles, syringes

Definitions

  • This invention relates to safety devices for medical or veterinary use.
  • the invention relates to a protective cover for a hypodermic needle and to a method for the manufacture of the cover.
  • hypodermic needles In the clinical uses of hypodermic needles there are several hazards and issues of concern regarding public health.
  • Needle-stick injuries are a major cause of morbidity in health-care workers, refuse handlers and, to a lesser extent, the general public.
  • needle-stick injuries may be defined as the sharp of a needle penetrating or tearing a victim's skin.
  • a needle-stick injury there may or may not be an added hazard of contaminated blood or body fluid present in or on the needle that may then be transferred to the victim.
  • hypodermic needles A major public health concern with hypodermic needles is the re-use of the needle by multiple users. Such re-use or sharing of needles is believed to be the predominant means of transfer of diseases such as HIV, Hepatitis B, Hepatitis C and similar blood-borne viruses.
  • the device would be robust and impact resistant and ideally would be economical to manufacture and fit to existing designs of needle.
  • the present invention seeks to satisfy this need.
  • This invention accordingly provides a protective cover for a hypodermic needle comprising:
  • the latching means is released allowing the sheath to move in response to the biasing means so that, as the needle is withdrawn from the patient, the sheath extends along the needle shaft to a point substantially against the patient's skin and, as the withdrawal of the needle continues, the sheath further extends substantially against the patient's skin until it completely encases the needle.
  • the invention also provides a method for the manufacture of a protective cover for a hypodermic needle comprising:
  • the sheath is composed of neoprene latex.
  • the biasing means comprises a coil-spring arranged so that the shaft of the needle passes through a lumen formed by the coils.
  • the end of the spring that is disposed towards the tip end of the needle is a tightly wound cone of suitable dimensions to enclose and provide protection to the needle tip.
  • the coil-spring is embedded within the wall of the sheath.
  • the protective cover is configured so that a safety cap, such as is known in the art, can be fitted over the needle and cover. It is preferred that the cover is designed so that the safety cap can be fitted over the needle with the sheath in cither its compressed or extended position.
  • the coil-spring is provided with a tight coil-spring cone at its outer end.
  • the tip of the dipping mould is designed such that, in the dipping step, the latex is not able to flow within the cone but covers the outside only.
  • the medical grade latex is neoprene latex and that the spring is composed of World Health Organisation-approved stainless steel.
  • Figure 1 illustrates a protective cover mounted in place on a hypodermic needle. In this view the sheath is in its compressed and latched position.
  • Figure 2 shows the protective cover of Figure 1 in which the sheath is unlatched and is encasing the needle.
  • Figure 3 illustrates a dipping mould that is used for forming a neoprene latex sheath.
  • Figure 4 shows the mould of Figure 3 with a coil-spring mounted in position ready for dipping.
  • FIG. 5 illustrates the configuration of a preferred stainless steel coil-spring for use in the invention.
  • a hypodermic needle with a protective cover in a compressed, ready for use position is shown in association with a syringe in Figure 1.
  • a similar needle is shown after use, encased by the cover in Figure 2.
  • Figure 1 can be seen a needle (1 ) having a hub (6) for attachment to a syringe (8) as is known in the art.
  • the protective cover is latched into a compressed position by a cone section latching means (9) having finger tabs (2) to aid in unlatching and a frangible snap seal (3) the breaking of which unlatches the cover.
  • the neoprene-dipped spring is compressed and housed within the latching means (9). That construction is then fixed to the hub (6) of the needle by the engagement of three "tight" coils (16), located at the open end of the spring (15), with a narrowed shoulder (5) on the hub.
  • FIG. 5 A preferred configuration of a spring (15) is shown in Figure 5 in which can be seen a tightly wound conical tip (12) of about 10 mm in length and having a tip opening of about 3.2 mm in diameter.
  • the body of the spring has a 2.36 mm pitch and is of about 35 mm in length and from 5.35 to 5.85 in diameter.
  • At the base end of the spring are three contiguous tightly wound coils (16).
  • FIG. 3 Shown in Figures 3 and 4, is a specially designed dipping mould for use in manufacturing a protective cover according to the invention.
  • the mould is constructed from standard stock 316 stainless steel rod.
  • the base of the rod is provided with a drilled and tapped thread (19) to allow the mould to be attached to a holder (not shown).
  • the mould At its tip end, the mould has a conical section ( 18) that is complementary with the conical tip ( 12) of the spring ( 15). 1.ocatcd at a point about 35 mm from the shoulders of the conical section ( 18), is a rounded rise ( 1 7) adapted to engage the tight coils (16) of the spring (15).
  • a conical tipped spring is loaded onto the dipping mould and held in place by the rounded rise (17) as indicated in
  • the mould is dipped into a neoprene latex medium of controlled viscosity and gelling strength.
  • the latex viscosity is controlled by the use of a standard efflux tube or by zhan cup timed in various degrees of seconds whilst gelling strength is controlled by varying the amount by weight of added calcium nitrate.
  • the neoprene latex is allowed to flow under and over the spring creating a tube sheath of approximately 0.5mm in thickness between the outer side of the spring and the dipping mould.
  • the tight coil-spring cone in conjunction with the design of the mould, does not allow latex to flow within the cone.
  • the latex covers the outer side only.
  • the sheath with its embedded spring is removed from the mould and mounted on a hypodermic needle by a suitable adhesive process, as is known in the art.
  • the sheath is compressed against the bias of the spring, piercing the tapered end of the sheath and allowing the needle to protrude.
  • the sheath is held in this position by the conical latching means.
  • the protective cover has an impact resistance of approximately 15PSI.
  • Other devices in the prior art are only able to withstand pressures of 5PSI or less.

Abstract

A protective cover for a hypodermic needle (1) comprises a flexible fluid impermeable sheath, compressed against biasing means (15) down the shaft of the needle exposing the needle for use. The sheath is latched into this compressed position by a latching means (9). The needle is inserted into a patient, blood drawn or medication injected, the latching means is released allowing the sheath to move to a covering position along the length of the needle to a point substantially against the patient's skin. As the needle is further withdrawn, the sheath extends whilst maintaining contact with the skin until it completely encases the needle. A method of manufacturing a protective cover is also defined. The method has the steps of; providing a dipping mould and a coiled spring, the spring and mould being attached; dipping the mould and spring into medical grade latex medium, such that the latex flows over and under the spring to form a tube with the spring embedded in the wall.

Description

Title of Invention:
Hypodermic Needle Protective Cover.
Field of Invention:
This invention relates to safety devices for medical or veterinary use. In particular, the invention relates to a protective cover for a hypodermic needle and to a method for the manufacture of the cover.
Background of the Invention:
In the clinical uses of hypodermic needles there are several hazards and issues of concern regarding public health.
Needle-stick injuries are a major cause of morbidity in health-care workers, refuse handlers and, to a lesser extent, the general public. In this context, needle-stick injuries may be defined as the sharp of a needle penetrating or tearing a victim's skin.
In a needle-stick injury there may or may not be an added hazard of contaminated blood or body fluid present in or on the needle that may then be transferred to the victim.
In addition, even if there is no needle-stick injury per se, contaminants on the needle may still be transferred to a victim through an existing open wound or through contact with the mucous membranes (such as by wiping the eye or mouth with a contaminated hand).
A major public health concern with hypodermic needles is the re-use of the needle by multiple users. Such re-use or sharing of needles is believed to be the predominant means of transfer of diseases such as HIV, Hepatitis B, Hepatitis C and similar blood-borne viruses.
Thus, there is a need for a reliable device that can protect the sharp tip of a hypodermic needle after use, contain body fluids after use and prevent or discourage the re-use of the needle.
Advantageously, the device would be robust and impact resistant and ideally would be economical to manufacture and fit to existing designs of needle.
The present invention seeks to satisfy this need.
Summary of the Invention:
This invention accordingly provides a protective cover for a hypodermic needle comprising:
a flexible, fluid impermeable sheath encasing a needle;
biasing means; and
latching means;
in which the sheath is compressed against the biasing means down the shaft of the needle thereby exposing the needle ready for use and the sheath is latched into that compressed position by the latching means; and
whereas, in use, the needle is inserted into a patient, blood drawn or medication injected, then the latching means is released allowing the sheath to move in response to the biasing means so that, as the needle is withdrawn from the patient, the sheath extends along the needle shaft to a point substantially against the patient's skin and, as the withdrawal of the needle continues, the sheath further extends substantially against the patient's skin until it completely encases the needle.
The invention also provides a method for the manufacture of a protective cover for a hypodermic needle comprising:
providing a dipping mould and a coiled spring;
attaching the spring to the dipping mould;
providing a medical grade latex medium of selected appropriate conditions of viscosity and gelling strength; and
dipping the mould and attached spring into the latex medium in such a manner that the latex flows under and over the spring thereby forming a tube with the spring embedded in its wall.
Preferred Aspects of the Invention:
It is preferred that the sheath is composed of neoprene latex.
It is further preferred that the biasing means comprises a coil-spring arranged so that the shaft of the needle passes through a lumen formed by the coils. In addition, it is advantageous if the end of the spring that is disposed towards the tip end of the needle is a tightly wound cone of suitable dimensions to enclose and provide protection to the needle tip.
In particular, it is further preferred that the coil-spring is embedded within the wall of the sheath.
Advantageously, the protective cover is configured so that a safety cap, such as is known in the art, can be fitted over the needle and cover. It is preferred that the cover is designed so that the safety cap can be fitted over the needle with the sheath in cither its compressed or extended position.
In a preferred embodiment of the method according to the invention, it is most preferred that the coil-spring is provided with a tight coil-spring cone at its outer end.
In addition, it is further preferred that the tip of the dipping mould is designed such that, in the dipping step, the latex is not able to flow within the cone but covers the outside only.
It is particularly prefen'ed that the medical grade latex is neoprene latex and that the spring is composed of World Health Organisation-approved stainless steel.
Brief Description of the Drawings:
Figure 1 illustrates a protective cover mounted in place on a hypodermic needle. In this view the sheath is in its compressed and latched position.
Figure 2 shows the protective cover of Figure 1 in which the sheath is unlatched and is encasing the needle.
Figure 3 illustrates a dipping mould that is used for forming a neoprene latex sheath.
Figure 4 shows the mould of Figure 3 with a coil-spring mounted in position ready for dipping.
Figure 5 illustrates the configuration of a preferred stainless steel coil-spring for use in the invention. Detailed Description with Respect to the Drawings:
A hypodermic needle with a protective cover in a compressed, ready for use position is shown in association with a syringe in Figure 1. A similar needle is shown after use, encased by the cover in Figure 2.
In Figure 1 can be seen a needle (1 ) having a hub (6) for attachment to a syringe (8) as is known in the art. The protective cover is latched into a compressed position by a cone section latching means (9) having finger tabs (2) to aid in unlatching and a frangible snap seal (3) the breaking of which unlatches the cover.
After use, as shown in Figure 2, pressure is applied to the finger tabs (2) to break the seal (3) and the two halves of the latching means (9) swing away from the cover on hinges (4). By the action of the released coil-spring (15), the sheath of the cover extends until it completely encases the needle shaft (1). Protection for the sharp tip of the needle is provided by the tightly wound conical tip (12) of the coil-spring (15).
During assembly of the needle and cover, the neoprene-dipped spring is compressed and housed within the latching means (9). That construction is then fixed to the hub (6) of the needle by the engagement of three "tight" coils (16), located at the open end of the spring (15), with a narrowed shoulder (5) on the hub.
A preferred configuration of a spring (15) is shown in Figure 5 in which can be seen a tightly wound conical tip (12) of about 10 mm in length and having a tip opening of about 3.2 mm in diameter. The body of the spring has a 2.36 mm pitch and is of about 35 mm in length and from 5.35 to 5.85 in diameter. At the base end of the spring are three contiguous tightly wound coils (16).
Shown in Figures 3 and 4, is a specially designed dipping mould for use in manufacturing a protective cover according to the invention. The mould is constructed from standard stock 316 stainless steel rod. The base of the rod is provided with a drilled and tapped thread (19) to allow the mould to be attached to a holder (not shown). At its tip end, the mould has a conical section ( 18) that is complementary with the conical tip ( 12) of the spring ( 15). 1.ocatcd at a point about 35 mm from the shoulders of the conical section ( 18), is a rounded rise ( 1 7) adapted to engage the tight coils (16) of the spring (15). A conical tipped spring is loaded onto the dipping mould and held in place by the rounded rise (17) as indicated in
Figure 4.
The mould is dipped into a neoprene latex medium of controlled viscosity and gelling strength. The latex viscosity is controlled by the use of a standard efflux tube or by zhan cup timed in various degrees of seconds whilst gelling strength is controlled by varying the amount by weight of added calcium nitrate.
The neoprene latex is allowed to flow under and over the spring creating a tube sheath of approximately 0.5mm in thickness between the outer side of the spring and the dipping mould. The tight coil-spring cone, in conjunction with the design of the mould, does not allow latex to flow within the cone. The latex covers the outer side only.
After curing, the sheath with its embedded spring is removed from the mould and mounted on a hypodermic needle by a suitable adhesive process, as is known in the art. The sheath is compressed against the bias of the spring, piercing the tapered end of the sheath and allowing the needle to protrude. The sheath is held in this position by the conical latching means.
After use of the needle, when the latching means is disengaged and the sheath is extended, as the sheath passes over the tip of the needle the hole in the latex closes over thus totally encasing the needle and preventing the escape of any contaminating material. In this extended position, because of the structure and configuration of the stainless steel coil-spring, the protective cover has an impact resistance of approximately 15PSI. Other devices in the prior art are only able to withstand pressures of 5PSI or less.

Claims

Claims:
1 A protective cover for a hypodermic needle comprising:
a flexible, fluid impermeable sheath encasing a needle;
biasing means; and
latching means;
in which the sheath is compressed against the biasing means down the shaft of the needle thereby exposing the needle ready for use and the sheath is latched into that compressed position by the latching means; and
whereas, in use, the needle is inserted into a patient, blood drawn or medication injected, then the latching means is released allowing the sheath to move in response to the biasing means so that, as the needle is withdrawn from the patient, the sheath extends along the needle shaft to a point substantially against the patient's skin and, as the withdrawal of the needle continues, the sheath further extends substantially against the patient's skin until it completely encases the needle.
2 A cover as defined in claim 1 in which the sheath is composed of neoprene latex.
3 A cover as defined in claim 1 in which the biasing means comprises a coil-spring arranged so that the shaft of the needle passes through a lumen formed by the coils.
4 A cover as defined in claim 3 in which the end of the spring that is disposed towards the tip end of the needle is a tightly wound cone of suitable dimensions to enclose and provide protection to the needle tip.
5 A cover as defined in claims 3 or 4 in which the coil-spring is embedded within the wall of the sheath. A cover as defined in claims 1 or 3 in which the protective cover is configured so that a safety cap, such as is known in the art, can be fitted over the needle and cover.
A cover as defined in claim 6 in which the cover is designed so that the safety cap can be fitted over the needle with the sheath in either its compressed or extended position.
A method for the manufacture of a protective cover for a hypodermic needle comprising:
providing a dipping mould and a coiled spring;
attaching the spring to the dipping mould;
providing a medical grade latex medium of selected appropriate conditions of viscosity and gelling strength; and
dipping the mould and attached spring into the latex medium in such a manner that the latex flows under and over the spring thereby forming a tube with the spring embedded in its wall.
A method as defined in claim 8 in which the coil-spring is provided with a tight coil-spring cone at its outer end.
A method as defined in claims 8 or 9 in which the tip of the dipping mould is designed such that, in the dipping step, the latex is not able to flow within the cone but covers the outside only.
A method as defined in claims 8 or 9 in which the medical grade latex is neoprene latex and the spring is composed of World Health Organisation-approved stainless steel.
PCT/AU2000/001252 1999-10-15 2000-10-16 Hypodermic needle protective cover WO2001028611A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU10072/01A AU780560B2 (en) 1999-10-15 2000-10-16 Hypodermic needle protective cover

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPQ3446 1999-10-15
AUPQ3446A AUPQ344699A0 (en) 1999-10-15 1999-10-15 Hypodermic needle protective cover

Publications (2)

Publication Number Publication Date
WO2001028611A2 true WO2001028611A2 (en) 2001-04-26
WO2001028611A3 WO2001028611A3 (en) 2002-04-18

Family

ID=3817603

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2000/001252 WO2001028611A2 (en) 1999-10-15 2000-10-16 Hypodermic needle protective cover

Country Status (2)

Country Link
AU (1) AUPQ344699A0 (en)
WO (1) WO2001028611A2 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8821453B2 (en) 2011-07-25 2014-09-02 Safety Syringes, Inc. Folding panel needle guard
CN106730141A (en) * 2016-12-23 2017-05-31 欧阳小青 A kind of safe type retention needle
CN106730142A (en) * 2016-12-23 2017-05-31 欧阳小青 A kind of protection device of puncture needle Anti-stabbing

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775369A (en) * 1986-09-09 1988-10-04 Boris Schwartz Automatically actionable sharpened needle-tip protection
US4795432A (en) * 1987-02-19 1989-01-03 Karczmer Claude M Shield assembly for hypodermic injection devices
EP0405039A1 (en) * 1989-06-27 1991-01-02 Poirier Guerineau Self-retractable syringe-needle combination
WO1994019036A1 (en) * 1993-02-26 1994-09-01 Daniel Guillet Syringe needle protecting device
US5769828A (en) * 1996-06-13 1998-06-23 Medtronic, Inc. Two-stage venous cannula with expandable reinforcing member

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775369A (en) * 1986-09-09 1988-10-04 Boris Schwartz Automatically actionable sharpened needle-tip protection
US4795432A (en) * 1987-02-19 1989-01-03 Karczmer Claude M Shield assembly for hypodermic injection devices
EP0405039A1 (en) * 1989-06-27 1991-01-02 Poirier Guerineau Self-retractable syringe-needle combination
WO1994019036A1 (en) * 1993-02-26 1994-09-01 Daniel Guillet Syringe needle protecting device
US5769828A (en) * 1996-06-13 1998-06-23 Medtronic, Inc. Two-stage venous cannula with expandable reinforcing member

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8821453B2 (en) 2011-07-25 2014-09-02 Safety Syringes, Inc. Folding panel needle guard
US9925341B2 (en) 2011-07-25 2018-03-27 Safety Syringes, Inc. Folding panel needle guard
CN106730141A (en) * 2016-12-23 2017-05-31 欧阳小青 A kind of safe type retention needle
CN106730142A (en) * 2016-12-23 2017-05-31 欧阳小青 A kind of protection device of puncture needle Anti-stabbing

Also Published As

Publication number Publication date
AUPQ344699A0 (en) 1999-11-11
WO2001028611A3 (en) 2002-04-18

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