U.S. patent number RE36,398 [Application Number 09/116,673] was granted by the patent office on 1999-11-16 for safety device for hypodermic needle or the like.
This patent grant is currently assigned to BTG International Limited. Invention is credited to Phillip O. Byrne, Harry R. Ingham, Penelope R. Seiders.
United States Patent |
RE36,398 |
Byrne , et al. |
November 16, 1999 |
**Please see images for:
( Certificate of Correction ) ** |
Safety device for hypodermic needle or the like
Abstract
A safety device for a hypodermic needle or for a similar
instrument used in the clinical puncture of the skin comprises a
sheath (6, 25 or 32) adapted to be connected to the needle (5, 21
or 33) or to a support (4 or 31) for the needle. The sheath is so
connected in a first position (FIGS. 1A, 2A, or 3A) which permits
normal use of the needle and can be placed, by movement relative to
the needle (FIGS. 1B or 3B) or by folding upon itself (FIGS. 2B and
2C) in a second position in which the needle is encapsulated by the
sheath. The sheath is retained in that second position, for example
by a projection (9, 27 or 35) extending into a slot (10 or 36) or
through an aperture (28).
Inventors: |
Byrne; Phillip O. (Newcastle
Upon Tyne, GB), Seiders; Penelope R. (Newcastle Upon
Tyne, GB), Ingham; Harry R. (Newcastle Upon Tyne,
GB) |
Assignee: |
BTG International Limited
(GB)
|
Family
ID: |
26289565 |
Appl.
No.: |
09/116,673 |
Filed: |
July 16, 1998 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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160859 |
Dec 3, 1993 |
5601535 |
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709999 |
Jun 4, 1991 |
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595664 |
Oct 11, 1990 |
5084030 |
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241256 |
Sep 7, 1988 |
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888376 |
Jul 23, 1986 |
4826490 |
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Reissue of: |
435396 |
May 5, 1995 |
05549572 |
Aug 27, 1996 |
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Foreign Application Priority Data
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Jul 29, 1985 [GB] |
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8519049 |
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Current U.S.
Class: |
604/198; 604/110;
604/263 |
Current CPC
Class: |
A61M
5/3202 (20130101); A61M 5/3216 (20130101); A61M
5/3271 (20130101); A61M 2005/3217 (20130101); A61M
5/3272 (20130101) |
Current International
Class: |
A61M
5/32 (20060101); A61M 005/32 () |
Field of
Search: |
;604/110,192,198,263 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2119148 |
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Jul 1948 |
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AU |
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201484 |
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Feb 1955 |
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AU |
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164214 |
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Mar 1955 |
|
AU |
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202213 |
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May 1955 |
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AU |
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232255 |
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Sep 1959 |
|
AU |
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253057 |
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Jun 1963 |
|
AU |
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57556/69 |
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Feb 1971 |
|
AU |
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13731/70 |
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Oct 1971 |
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AU |
|
813433 |
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Jul 1951 |
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DE |
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49-4797 |
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Feb 1974 |
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JP |
|
924734 |
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May 1963 |
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GB |
|
1233302 |
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May 1971 |
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GB |
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1297746 |
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Nov 1972 |
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GB |
|
2059268 |
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Apr 1981 |
|
GB |
|
2114006 |
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Aug 1983 |
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GB |
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Primary Examiner: McDermott; Corrine
Attorney, Agent or Firm: Nixon & Vanderhye P.C.
Parent Case Text
This is a continuation of Ser. No. 08/160,859 filed Dec. 3, 1993
.Iadd.(now U.S. Pat. No. 5,601,535).Iaddend., which is a
continuation of Ser. No. 07/709,999 filed Jun. 4, 1991 .Iadd.(now
abandoned).Iaddend., which a continuation of Ser. No. 07/595,664
filed Oct. 11, 1990 (now U.S. Pat. No. 5,084,030), which is a
continuation of 07/241,256 filed Sep. 7, 1988 (now abandoned),
which is a continuation of Ser. No. 06/888,376 filed Jul. 23, 1986
(now U.S. Pat. No. 4,826,490).
Claims
We claim:
1. For use with clinical apparatus operably applicable to a patient
by way of a deliberate skin puncture, a needle assembly operable to
effect said skin puncture and comprising:
a support structure;
a needle fixedly mounted in said structure to form therewith a
sub-assembly, with one end portion of said needle projecting from
said structure, and said one end portion terminating in a
skin-puncturing tip;
a guard mounted around part of said sub-assembly for movement
relative thereto in the longitudinal direction of said needle from
a first position in which said tip is exposed to effect said
deliberate puncture, to a second position in which said tip is
embraced by said guard to prevent unintended skin puncture;
a locking mechanism including first and second elements, said first
element being a projection from one of said sub-assembly and guard,
said second element being a stop surface defining a space bordering
the other of said sub-assembly and guard, said elements each
extending transversely of said needle longitudinal direction, said
elements being spaced apart in said longitudinal direction when
said guard is in said first position, said projection being subject
to a bias force acting between said sub-assembly and guard during
said relative movement, and said projection being automatically
irreversibly moved into said space alongside said stop surface in
response to said bias force when said guard is in said second
position to inhibit a returning relative movement thereof towards
said first position; and
a stop mechanism effective to constrain said guard from movement
towards and around said apparatus.
2. An assembly according to claim 1 wherein said locking mechanism
second element stop surface defines said space as a recess in the
other of said sub-assembly and guard.
3. An assembly according to claim 1 wherein, to serve as said stop
mechanism, said support structure has a portion with external
dimensions transversely of said longitudinal direction which are
enlarged relative to the remainder of the structure, and said guard
has lesser corresponding internal transverse dimensions around said
structure than said portion.
4. For use with clinical apparatus operably applicable to a patient
by way of a deliberate skin puncture, a needle assembly operable to
effect said skin puncture and comprising:
a support structure;
a needle fixedly mounted in said structure to form therewith a
sub-assembly, with one end portion of said needle projecting from
said structure, and said one end portion terminating in a
skin-puncturing tip;
a guard mounted around part of said sub-assembly for movement
relative thereto in the longitudinal direction of said needle from
a first position in which said tip is exposed to effect said
deliberate puncture, to a second position in which said tip is
embraced by said guard to prevent unintended skin puncture;
a locking mechanism including first and second elements, said first
element being a projection from one of said sub-assembly and guard,
said second element being a stop surface defining a space bordering
the other of said sub-assembly and guard, said elements each
extending transversely of said needle longitudinal direction, said
elements being spaced apart in said longitudinal direction when
said guard is in said first position, said projection being subject
to a bias force acting between said sub-assembly and guard during
said relative movement, and said projection being automatically
irreversibly moved into said space alongside said stop surface in
response to said bias force when said guard is in said second
position to inhibit a returning relative movement thereof towards
said first position;
a stop mechanism effective to constrain said guard from movement
towards and around said apparatus;
said stop mechanism including a portion of said support structure
having external dimensions transversely of said longitudinal
direction which are enlarged relative to the remainder of the
structure, and said guard having lesser corresponding internal
transverse dimensions around said structure than said portion;
said support structure having a connector formation for removable
attachment with said clinical apparatus, which formation includes
said transversely enlarged portion. .Iadd.
5. For use with clinical apparatus operably applicable to a patient
by way of a deliberate skin puncture, a needle assembly operable to
effect said skin puncture and comprising:
a hollow support structure;
a needle fixedly mounted on said structure adjacent one end thereof
to form therewith a sub-assembly, with one end portion of said
needle projecting from said structure, and said one end portion
terminating in a skin puncturing tip having an opening therein, the
needle being longitudinal hollow to provide a direct fluid flow
pathway extending therethrough between said opening in said tip and
the remainder of said needle from said one end portion, the needle
having no obstruction therein along the entire length of said
pathway so that direct fluid flow along the entire length of the
pathway is permitted;
said support structure including a connector formation at an
opposite end thereof from said needle to engage, in use of said
needle assembly, with the clinical apparatus, said connector
formation being integral with said support structure and having an
opening therethrough in communication through said support
structure with said pathway through said needle;
a guard mounted for movement relative to said sub-assembly and in a
longitudinal direction of said needle between a first position in
which said tip is exposed to effect said deliberate skin puncture
and a second position in which said guard extends in part
longitudinally beyond said tip to prevent unintended skin
puncture;
said guard being carried by said sub-assembly in a captive manner
to stop separation of said guard from said sub-assembly by movement
from said first position in the longitudinal direction away from
said second position;
a projection carried by said guard and projecting generally
laterally of the longitudinal direction of said needle, said
projection engaging said sub-assembly during said relative movement
of said guard and said sub-assembly from said first position
towards said second position;
said projection being subject to a biasing force acting between
said guard and part of said sub-assembly during said relative
movement of said guard and said sub-assembly;
said projection being automatically displaced in a general lateral
direction in response to said relative movement of said guard and
said sub-assembly to lock said guard and said sub-assembly in said
second position. .Iaddend..Iadd.
6. An assembly according to claim 5 wherein said sub-assembly
includes a guide for guiding said projection along said
sub-assembly and throughout the extent of said relative movement of
said guard and said sub-assembly from said first position to said
second position. .Iaddend..Iadd.7. An assembly according to claim 6
wherein said guide includes a groove formed in said sub-assembly.
.Iaddend..Iadd.8. An assembly according to claim 5 wherein said
projection is subject to said biasing force throughout the extent
of said relative movement of said guard and said sub-assembly from
said first position to said second position. .Iaddend..Iadd.9. An
assembly according to claim 5 wherein said projection engages said
sub-assembly in said second position of said guard and said
sub-assembly. .Iaddend..Iadd.10. An assembly according to claim 5
wherein said projection is subject to said biasing force throughout
the extent of said relative movement of said guard and said
sub-assembly from said first position to said second position, said
projection engaging said sub-assembly in said second position of
said guard and said sub-assembly. .Iaddend..Iadd.11. For use with
clinical apparatus operably applicable to a patient by way of a
deliberate skin puncture, a needle assembly operable to effect said
skin puncture and comprising:
an elongated support structure having first and second ends and a
first direct fluid flow pathway between said ends, said first end
adapted for connection and fluid communication with the clinical
apparatus:
a needle fixedly mounted adjacent said second end of said structure
to form therewith a sub-assembly, one end portion of said needle
projecting from said structure and terminating in a skin puncturing
tip having an opening therein, the needle being longitudinally
hollow to provide a second direct fluid flow pathway extending
therethrough between said opening in said tip and the remainder of
said needle from said one end portion and in open communication
with said first pathway to form a continuous direct fluid flow
pathway between said support structure first end and said opening
in said tip, the needle and said support structure having no
obstruction therein along the entire length of said continuous
pathway so that direct fluid flow along the entire length of said
continuous pathway is permitted;
a guard mounted for movement relative to said sub-assembly and in a
longitudinal direction of said needle between a first position in
which said tin is exposed to effect said deliberate skin puncture
and a second position in which said tip is enclosed by said guard
to prevent unintended skin puncture;
said guard being carried by said sub-assembly in a captive manner
to stop separation of said guard from said sub-assembly by movement
from said first position in the longitudinal direction away from
said second position;
a projection carried by one of said sub-assembly and said guard and
projecting generally laterally of the longitudinal direction of
said needle;
a guide slot extending along at least one side of another of said
sub-assembly and said guard generally in the longitudinal direction
of the needle and terminating at one end in a recess having a stop
surface;
said projection engaging in said slot in said first position of
said guard and said sub-assembly and engaging along said slot
during said relative movement of said guard and said sub-assembly
from said first position to said second position;
said projection extending into said recess upon said relative
movement of said guard and said sub-assembly into said second
position and engageable against said stop surface to prevent
relative movement of said guard and said sub-assembly from said
second position toward said first position;
said guard in said second position extending in part longitudinally
beyond
said needle tip and enclosing said needle tip. .Iaddend..Iadd.12.
An assembly according to claim 11 including a lateral enlargement
of said guard adjacent an end thereof remote from said needle in
said second position of said guard. .Iaddend..Iadd.13. An assembly
according to claim 12 wherein said enlargement has an arcuate
surface providing a finger-engaging surface. .Iaddend..Iadd.14. An
assembly according to claim 11 wherein said projection and said
another of said guard and said sub-assembly are subject to a
biasing force substantially throughout the extent of relative
movement of said guard and said sub-assembly from said first
position to said second position enabling said projection to engage
said stop surface in said second position of said guard and said
sub-assembly to prevent said movement from said second position
toward said first position. .Iaddend..Iadd.15. An assembly
according to claim 11 wherein said guide slot is formed along said
guard and said projection projects from said sub-assembly.
.Iaddend..Iadd.16. An assembly according to claim 11 wherein said
guide slot is formed along said sub-assembly and said projection
projects from said guard. .Iaddend.
Description
The present invention is a safety device for a hypodermic needle or
similar instrument used in the clinical puncture of the skin.
The taking of blood samples from persons in hospitals, health
centres or other clinical areas is a routine medical procedure, as
is the injection of pharmnaceutical preparations or biological
materials. However, many incidents have been reported in the press
and in medical journals of clinical operators subsequently
accidentally wounding themselves or other persons with the needle
and thereby either transmitting a disease or causing chemical or
biological poisoning.
There is a clear need for a device which permits the disposal of a
hypodermic needle or such instrument in a manner which protects the
clinical operator, observers of the clinical procedure and all
other persons concerned, including the general public, from
accidental wounding.
It is an object of the present invention to provide such a
device.
The safety device according to the invention for a hypodermic
needle or similar instrument comprises a sheath, adapted to be
connected to said needle or other instrument or to a support
therefor in a first position which permits normal use of said
needle or other instrument and to be placeable, by movement
relative to the needle or other instrument or by folding upon
itself, in a second position in which the needle or other
instrument is encapsulated by the sheath and the sheath is retained
in that second position.
As indicated, the safety device of the present invention is
generally applicable to the protection of puncturing instruments
typified by hypodermic needles, although among such instruments
hypodermic needles are by far the most widely used. For example,
the device may be applied to the protection of biopsy needles,
winged needles, that is needles provided with lateral attachments
to enable them to be affixed to the skin surface as by adhesive
tape, and to intravenous cannulas and lumbar puncture needles. For
convenience, the invention is hereinafter described specifically as
applied to "needles", in particular hypodermic needles, but it is
emphasised that the invention is not to be limited thereby.
The sheath is adapted to be attached to the needle or to a support
for the needle but may be provided separately from the needle, to
be attached to the needle or support at the point of use, either
before or after the needle has actually been used It is much
preferred that such separate sheaths be attached before use, so
that the needle may be more readily encapsulated immediately after
it has been used. However, the sheath according to the present
invention is preferably and conveniently supplied already attached
to the needle. In particular, it is preferably attached either
irremovably or in a way which makes its removal diificult. For
example, the sheath may be adhered to the needle or to a support
for the needle or may be clipped to the needle or support.
When the needle is designed for use without a syringe or remote
from an associated syringe, to which it is then linked by a
flexible tube, then the sheath is preferably secured direct to the
needle. The sheath may then conveniently incorporate one or more
parts which are foldable relative to the body of the sheath and
thereby to encapsulate the needle.
When the needle, on the other hand, is mounted upon a housing
designed to be attached to a syringe barrel or luer connector, then
the sheath may advantageously be secured to the housing. The sheath
may then be capable of movement relative to the housing in a
direction which has a component parallel to the length of the
needle, so that the sheath may be moved along the length of the
needle until the latter is fully encapsulated. This relative
movement of sheath and housing may for example be a linear sliding
movement or a spiral movement, as more particularly exemplified
hereinafter in FIGS. .[.3A.]. .Iadd.2A .Iaddend.and .[.3B.].
.Iadd.5A .Iaddend.of the drawings.
Such relative movement of sheath and housing may be determined by
one or more linear or spiral grooves or channels in the housing
engaging one or more lugs or other projections on the sheath--or
grooves or channels in the sheath engaging projections on the
housing.
In the second position of the sheath, in which the needle is
encapsulated, the sheath is retained against further movement
relative to the needle. That retaining of the sheath is preferably
irreversible or reversible only with difficulty. For example, one
or more lugs or other projections on one of the relatively movable
components may engage one or more apertures or slots in the other
component, preferably under the pressure of a natural resilience in
at least one of the components or under pressure from one or more
springs.
The sheath may advantageously and conveniently be made from a
resilient plastics material, for example polypropylene, and the
housing may be made from the same, or a similar, material.
The invention will now be further described with reference to the
accompanying drawings, wherein:
FIG. 1A is a sectional view of a first embodiment of the safety
device according to the present invention, in a position in which
the needle may be used normally;
FIG. 1B is an enlarged detailed view of the circled portion of FIG.
1A;
FIG. 2A is a view corresponding to that of FIG. 1A but with the
sheath moved to encapsulate the needle;
FIG. 2B is an enlarged detailed view of the circled portion of FIG.
2A;
FIG. 3 is a sectional view of a second embodiment of the safety
device according to the present invention, in a position in which
the needle may be used normally;
FIG. 4A is a view corresponding to that of FIG. 3 but with the
sheath folded to encapsulate the needle;
FIG. 4B is an enlarged view of the circled portion of FIG. 4A;
FIG. 4C is a plan view of the device in the position shown in FIG.
4A;
FIG. 5A is a view, partly in section of a third embodiment of the
safety device according to the present invention, in a position in
which the needle may be used normally;
FIG. 5B is a view corresponding to that of FIG. 5A but with the
sheath moved to encapsulate the needle;
FIG. 5C is an enlarged view of the circled portion of FIG.
5B.[...]. .Iadd.;
New FIG. 6 is a view similar to FIG. 5B illustrating a further form
of the guide slot and projection. .Iaddend.
The embodiment of the invention shown in FIGS. 1A and 1B comprises
a needle housing 4 in the form of a plastics moulding carrying a
needle 5 and, slidably supported upon the housing 4, a plastics
sheath 6 incorporating a thumb guard 7 integral therewith.
.Iadd.The thumb guard 7 constitutes a lateral enlargement of the
guard and as illustrated in FIG. 2A has an arcuate surface 7a
providing a finger-engaging surface. The needle housing 4 thus
comprises a hollow support structure and forms with needle 5 a
sub-assembly. .Iaddend.Also incorporated in the housing 4 and
running length-wise, is a channel 8. The sheath 6 incorporates a
self-springed spigot 9, which slides along the channel 8, as shown
in more detail in the enlarged inset. When the sheath travels to
the end of the channel 8, the self-springed spigot 9 drops into a
small "well" 10, thus locking the sliding sheath in position. The
length of the sheath is such that, when it is locked in position,
the sharp end of the needle is completely enclosed by the sheath,
as shown in FIG. 1B.
The housing 4 is designed to mate with any standard syringe barrel
or luer connector. After use, the protective sheath is extended
into the locked position, thus encapsulating the needle in a safe
manner.
The embodiment of the invention shown in FIGS. .[.2A to 2C.].
.Iadd.3 and 4A-4C .Iaddend.is designed to allow encapsulation of a
hypodermic needle 21 which is tethered to a syringe (not shown) by
an extension tube 22. The needle 21 is sandwiched between two
plastics mouldings or pressings 23,24 which together form a sheath
25. A part 26 of the sheath 25 is permanently attached to the
hypodermic needle. At points 23a and 24a the plastic is formed in a
manner which allows the free ends of members 23 and 24 to hinge as
indicated Near to its outer end, the member 23 carries two spigots
27, which are designed to mate with holes 28 in the member 24 (when
the sheath is in its folded position) and lock the sheath securely
around the needle 21.
The third embodiment of the invention, as illustrated in FIGS.
.[.5A and 5B.]. .Iadd.5A-5C.Iaddend., comprises a needle housing 31
in the form of a plastics moulding, a plastics sheath 32 which is
free to rotate thereon and a needle 33. Impressed into the housing
31 is helical groove 34 extending from near the end of the housing
31 which is distal to the needle 33 towards the needle. The sheath
32 has a self-springed spigot 35 which fits into, and is free to
move along, the helical groove 34 .Iadd.while subject to a biasing
force acting between the sheath 32 and housing 31 during relative
movement of the sheath and housing.Iaddend.. As shown in FIG.
.[.3B.]. .Iadd.5B.Iaddend., rotation of the sheath 32 in a
clockwise direction (viewed from the rear) will result in a forward
motion causing the sheath to encapsulate the needle 33. At the end
of its travel the springed spigot 35 drops into a "well" 36 thereby
locking the sheath in position. The length of the sheath 32 is such
that when it has reached this locked position the needle is
completely encapsulated and withdrawn beyond the orifice 37 in the
outer end of the sheath.
The device shown in FIGS. .[.3A and 3B.]. .Iadd.5A-5C .Iaddend.is
designed to mate with any standard syringe barrel or luer
connector. .Iadd.For example, as illustrated in FIG. 2A, a
connector formation is provided on an elongate body 40 including a
tapered abutment surface 42 for mating with the needle support
housing and having a complementary tapered abutment surface
44.Iaddend.. After use, the protective sheath is placed in position
by applying a twisting force to the sheath. To facilitate the
application of this twisting force, a raised section 38 may be
incorporated into the sheath's surface.
This form of the invention may be fabricated with one or more
helical grooves, which may extend in a clockwise or anti-clockwise
direction. For greater mechanical strength and stability, a double
helix may be preferred.
.Iadd.In FIG. 6, the groove 34a and spigot 35a are formed in the
sheath 32a and housing 31a, respectively, i.e., reversed as
previously described from the configuration of FIGS. 5A-5C.
.Iaddend.
* * * * *