U.S. patent application number 13/842000 was filed with the patent office on 2016-06-09 for frontal attachment device for syringe with pinch-activated retraction.
This patent application is currently assigned to Retractable Technologies, Inc.. The applicant listed for this patent is Retractable Technologies, Inc., Thomas J. Shaw. Invention is credited to Thomas J. Shaw, Mark Small, Ni Zhu.
Application Number | 20160158459 13/842000 |
Document ID | / |
Family ID | 51530720 |
Filed Date | 2016-06-09 |
United States Patent
Application |
20160158459 |
Kind Code |
A9 |
Shaw; Thomas J. ; et
al. |
June 9, 2016 |
Frontal Attachment Device for Syringe with Pinch-Activated
Retraction
Abstract
A retractable needle device attachable to the front of a fluid
collection or infusion device such as a syringe, the retractable
needle device comprising a housing having an engagement member, a
slide support surface, a retraction cavity and a first pinch
surface; a needle; a needle alignment member comprising a needle
tube and a second pinch surface; and a needle retraction mechanism
positioned within the needle tube and configured to bias the needle
rearwardly; wherein the first and second pinch surfaces are
configured so that a pinching force applied to them will cause
relative lateral movement between the housing and needle alignment
member. This translational movement from an injection position,
wherein the needle is aligned with the syringe connector, to a
retraction position, wherein the needle is aligned with the
retraction cavity, allows the needle retraction mechanism to force
the needle into the retraction cavity.
Inventors: |
Shaw; Thomas J.; (Frisco,
TX) ; Small; Mark; (Leonard, TX) ; Zhu;
Ni; (Plano, TX) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Retractable Technologies, Inc.;
Shaw; Thomas J. |
Frisco |
TX |
US
US |
|
|
Assignee: |
Retractable Technologies,
Inc.
Little Elm
TX
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20140276445 A1 |
September 18, 2014 |
|
|
Family ID: |
51530720 |
Appl. No.: |
13/842000 |
Filed: |
March 15, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13470855 |
May 14, 2012 |
8469927 |
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13842000 |
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|
12136462 |
Jun 10, 2008 |
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13470855 |
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13714819 |
Dec 14, 2012 |
9138545 |
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12136462 |
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Current U.S.
Class: |
604/198 |
Current CPC
Class: |
A61M 2005/3227 20130101;
A61M 2005/3236 20130101; A61M 5/345 20130101; A61M 5/3232
20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A retractable needle device selectively attachable to a fluid
collection or infusion device having a forwardly facing connector,
the retractable needle device comprising: a housing having a
rearwardly facing engagement member attachable to the forwardly
facing connector, a forwardly facing slide support surface having a
first opening in fluid communication with the engagement member and
a second opening laterally spaced apart from the first opening, the
second opening communicating with a rearwardly projecting needle
retraction cavity, a first pinch surface, and a fluid path between
the engagement member and the first opening; a needle; a needle
alignment member comprising a needle tube and a second pinch
surface; a needle retraction mechanism comprising a needle holder,
the needle holder positioned within the needle tube and configured
to bias the needle rearwardly; and an annular fluid seal seated in
the first opening and providing fluid communication between the
housing and the needle holder; wherein the first and second pinch
surfaces are configured so that a pinching force applied between
them will cause the housing to move laterally in relation to the
needle alignment member from a first position, wherein the needle
is aligned with the first opening, to a second position, wherein
the needle is aligned with the second opening so that the needle
retraction mechanism biases the needle into the retraction
cavity.
2. The retractable needle device of claim 1 further comprising a
retainer clip configured to retain the needle alignment member
adjacent to the slide support surface of the syringe engaging
member.
3. The retractable needle device of claim 2 wherein the retainer
clip comprises a forward surface, a hole defined in the forward
surface configured to surround the needle tube, and one or more
tabs configured to extend at least partially behind the slide
support surface.
4. The retractable needle device of claim 2 wherein the retainer
clip is configured to engage at least a portion of the needle
alignment member.
5. The retractable needle device of claim 1 wherein the engagement
member comprises a portion of a luer lock connector.
6. The retractable needle device of claim 5 wherein the engagement
member comprises a plurality of spaced-apart, radially-projecting
wedges configured to engage a threaded collar projecting forwardly
from the fluid collection or infusion device.
7. The retractable needle device of claim 1 further wherein the
fluid collection or infusion device is a syringe.
8. The retractable needle device of claim 1 wherein the fluid seal
is seated at least partially inside an annular recess inside the
first opening.
9. The retractable needle device of claim 1 wherein the fluid seal
comprises a fluid flow path that is coaxially aligned with the
needle holder prior to needle retraction.
10. The retractable needle device of claim 1 wherein the needle
retraction mechanism further comprises a compression spring.
11. The retractable needle device of claim 10 wherein the needle
holder is biased against the slide support surface whenever the
housing is disposed between the first and second positions.
13. The retractable needle device of claim 1 wherein a portion of
the needle holder projects forwardly from the needle tube.
14. The retractable needle device of claim 10 further comprising an
annular surface at a front end of the needle tube and an annular
shoulder defined on the needle holder and wherein the spring is
compressed between the annular surface and the annular shoulder
when the housing is in the first position.
15. The retractable needle device of claim 1 wherein the first and
second pinch tabs are textured to improve user grip.
16. The retractable needle device of claim 1 wherein the needle
alignment member and the syringe engaging member are each made of
moldable polymeric material.
17. The retractable needle device of claim 7 configured for use
with a syringe having a glass barrel.
18. The retractable needle device of claim 7 configured for use
with a syringe having a plastic barrel.
19. The retractable needle device of claim 7 configured for use
with a prefilled syringe.
20. The retractable needle device of claim 1 wherein the needle
retraction mechanism provides a retraction force upon activation
that is sufficient to retract the needle directly from a patient
into which the needle is inserted at the time of retraction.
21. The retractable needle device of claim 1 in combination with a
fluid collection or infusion device.
22. The retractable needle device of claim 1 in combination with a
needle cap.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 13/470,855, filed May 14, 2012, which is a
continuation of U.S. patent application Ser. No. 12/136,462, filed
Jun. 10, 2008, and the portions of those applications that relate
to the embodiments of FIGS. 4 and 5 as disclosed therein are
incorporated by reference into this application. This application
is also a continuation-in part of U.S. patent application Ser. No.
13/714,819, filed Dec. 14, 2012.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a newly disclosed frontal
attachment having a retractable needle that is attachable to
conventional medical devices such as syringes. The invention
relates more particularly to a medical device comprising in
combination a needle, needle positioner, needle retraction
mechanism, and a syringe engaging member with a retraction tube.
The subject device has a needle retraction mechanism that is
activated by pinching action and retracts the needle from a patient
and propels it into a retraction tube that is part of the hub
assembly.
[0004] 2. Description of Related Art
[0005] Conventional syringes comprising a generally cylindrical
barrel, a fixed needle projecting forwardly from the barrel, and a
plunger slidably disposed inside the barrel through an opening in
the rear of the barrel are well known. More recently, syringes have
been made with a luer connector on the front of the barrel to which
a needle hub is attachable to allow needles of different gauges or
sizes to be used with a commonly configured barrel.
[0006] Even more recently, in an effort to control the spread of
blood-borne pathogens and the incidence of contamination by contact
with either exposed needles or bodily fluids, syringes having fixed
or changeable needles have been designed to embody various "safety"
elements. Such "safety" elements should desirably include a
retractable needle, but many products marketed as having "safety"
elements include, for example, covers or guards that are manually
operated by medical personnel administering an injection to shield
or cover the needle tip following removal of the needle from a
patient.
[0007] Some previously disclosed needle retraction systems without
changeable needles are activated either manually or automatically
by application of a force upon completion of an injection to force
the needle and needle tip back inside a retraction chamber. The
only known syringe having a changeable, retractable needle does not
have a conventional luer lock connection, and the retraction
mechanism is activated by the application of a forwardly directed
force to the plunger handle following removal of the needle from a
patient, thereby exposing the needle and also exposing the user to
the risk of needle-stick injury.
[0008] Although many advancements in syringe technology have been
made in recent years, a frontal attachment device is needed that
can be used with a standard syringe having a conventional luer lock
connector, that offers the advantages of a changeable needle in
combination with the advantages of a retractable needle providing
sufficient retraction force to retract the needle while inserted
into a patient, and that can be activated simply and easily by the
application of a pinching force.
SUMMARY OF THE INVENTION
[0009] A medical device is disclosed that features automated needle
retraction wherein needle retraction is initiated by the
application of opposed compressive forces in line with a principal
sliding interface to reduce the likelihood of sticking, hang-up or
canting that could otherwise impede the translational movement of
one element of the device relative to another. As applied to a
syringe, the subject medical device further includes an automated
retraction device wherein the needle retraction mechanism can be
activated independently of the position of the plunger.
[0010] A retractable needle device is disclosed that comprises an
engagement member selectively attachable to a cooperatively
configured, forwardly facing portion of a medical device such as a
conventional syringe having a forwardly facing luer lock connector.
Other medical devices with which the retractable needle device can
be used can include, for example and without limitation, other
fluid collection or infusion devices that can utilize a retractable
needle. In addition to the engagement member, the retractable
needle device desirably comprises a retraction tube, a needle
alignment member comprising a needle tube, a rearwardly-biased
needle retraction mechanism seated inside the needle tube, a
retractable needle projecting forwardly of the needle alignment
member, and a fluid flow path from the fluid chamber through the
engagement member, needle tube, needle retraction mechanism and
needle, wherein the needle is retracted following use into the
retraction tube applying a pinching force. As used throughout this
disclosure, the terms "attachable," "detachable" and "changeable"
are generally used to characterize frontal attachments, such as
needles or needle/hub combinations, that are selectively attachable
to, detachable from, or otherwise changeable in relation to a
medical device such as a syringe for purposes such as, without
limitation, selecting a particular gauge needle for a particular
clinical use.
[0011] If desired, a retractable needle device as disclosed here
can also be made with a slip-fit luer cone, snap-on or other
attachment mechanism instead of a conventional luer lock connector
provided that the medical device with which it is used is
cooperatively configured. A retractable needle device as disclosed
here desirably comprises a needle that is retractable, and
retraction is activated by pinching pressure applied generally
perpendicularly to the longitudinal axis through the needle. A
satisfactory retractable needle device as disclosed here desirably
has sufficient retraction force to retract a needle that is still
inserted into a patient's body and thereby prevents exposure of the
contaminated needle to others. A retractable needle device as
disclosed here desirably utilizes a retraction tube that is not
embodied, for example, in a syringe barrel or plunger handle, and
is instead part of an attachable assembly.
[0012] Following an injection using a medical device provided with
the medical device disclosed here, a clinician administering the
injection desirably applies digital pressure to two opposed
textured tabs with a thumb and a finger. Application of pinching
pressure causes relative motion of the needle holder and needle
away from the syringe connector and toward the retraction tube.
This relative motion is continued until the needle holder is
aligned with a forwardly facing opening of the retraction tube, at
which point the needle retraction mechanism propels the needle
holder into the retraction tube. The needle holder carries the
attached needle rearwardly to a fully retracted position where the
needle is released from the patient and the needle tip no longer
projects forwardly from the needle tube. Also, using the device
disclosed here, if a clinician administering an injection needs or
decides to terminate the injection, the needle can be retracted to
prior to infusing all the fluid in a syringe.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The apparatus of the invention is further described and
explained in relation to the following drawings wherein:
[0014] FIG. 1 is a side elevation view of one embodiment of a
syringe with an attached retractable needle device;
[0015] FIG. 2 is a cross-sectional view of the apparatus of FIG. 1
taken along line 2-2 of FIG. 1;
[0016] FIG. 3 is an exploded view of the retractable needle device
of FIG. 1.
[0017] FIG. 4 is a perspective view illustrating cooperation of a
syringe connector of a retractable needle device with a luer lock
connection of a syringe barrel.
[0018] FIG. 5 shows the syringe and retractable needle device of
FIG. 1 after syringe plunger has been fully depressed.
[0019] FIG. 6 is a perspective view of a retractable needle device
being activated by a user.
[0020] FIG. 7 is a perspective view of a retractable needle device
prior to retraction of the needle.
[0021] FIG. 8 is a perspective view of a retractable needle device
after retraction of the needle.
[0022] FIG. 9 is an elevation view of the retractable needle device
of FIG. 8.
[0023] FIG. 10 is a cross-section view of the retractable needle
device of FIG. 9 taken along line 10-10.
[0024] FIG. 11 is an elevation view of the device as in FIG. 1 with
a needle cover installed.
[0025] FIG. 12 is a cross-sectional view of the device of FIG.
1.
[0026] Like reference numerals are used to describe like features
in all Figures of the drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] For illustrative purposes, the retractable needle device of
the invention is described below in relation to a medical device
that is a syringe assembly onto which a retractable needle device
of the invention has been releasably installed. It should be
appreciated, however, that the retractable needle device of the
invention is similarly useful for collecting or infusing fluids
with other medical devices that are not syringes.
[0028] FIGS. 1, 2 and 4 depict a syringe assembly 10 comprising
syringe barrel 20, having a luer lock connector 22, 23 disposed at
the front end and a plunger handle 26 with plunger seal 28 slidably
engaging the inside wall of syringe barrel 20, and a retractable
needle device 30 attached to luer lock connector 22, 23 so as to
establish fluid communication between fluid chamber 24 of syringe
barrel 20 and needle 32 of retractable needle device 30. Plunger
handle 26 extends rearwardly from an opening in the back of syringe
barrel 20 and is shown positioned as it could be prior to the
injection of a fluid disposed inside fluid chamber 24 into a
patient (not shown) if tip 34 of needle 32 were inserted into the
patient, recognizing that the position of plunger seal 28 relative
to syringe barrel 20 will depend upon the amount of fluid that is
drawn into fluid chamber 24. An injection force is applied to a
fluid disposed inside fluid chamber 24 through plunger handle 26 by
depressing thumb cap 27 of plunger handle 26 while stabilizing
syringe barrel 20 by applying oppositely directed finger force to
the forwardly facing surfaces of outwardly projecting flanges
29.
[0029] FIG. 3 is an exploded view of retractable needle device 30
further illustrating its components. Housing 36 preferably
comprises first pinch tab 35, luer lock tube 38, slide support
surface 41, and retraction tube 42. Connector tube 38 is desirably
configured to form a fluid tight seal between luer lock connector
22 of syringe barrel 20 and needle holder 46. Fluid seal 44
desirably comprises an elastomeric material and at least a portion
of fluid seal 44 is positioned within an annular recess 49 defined
in forwardly facing slide support surface 41. Fluid seal 44
provides a fluid seal between housing 36 or luer tip 22 and needle
holder 46. First pinch tab 35 preferably comprises ridges or other
texture to provide slip resistance when gripped with a finger or
thumb.
[0030] Forward of fluid seal 44 is needle holder 46, which is
attached to needle 32. Needle holder 46 comprises an axial bore
through a generally cylindrical elongate body 45 and larger
diameter head 47. Body 45 is preferably slightly longer than needle
tube 54. Retraction spring 48 is positioned around body 45 and is
compressed between an annular ledge inside the front end of needle
tube 54 and a forwardly facing annular shoulder between body 45 and
head 47. Prior to needle retraction, retraction spring 48 is under
compression and biases needle holder 46 and needle 32 rearwardly
relative to needle tube 54 and housing 36.
[0031] Retractable needle device 30 also comprises needle alignment
member 52. Needle alignment member 52 comprises a rearwardly facing
surface that slidably engages forwardly facing sliding surface 41
of housing 36, and further comprises forwardly projecting needle
tube 54 and second pinch tab 56. Second pinch tab 56 is desirably
positioned on an opposing side of syringe barrel 20 from first
pinch tab 35. Second pinch tab 56 is preferably textured similarly
to first pinch tab 35. A retainer clip 58 comprises a hole 62
configured to engage needle tube 54. Retainer clip 58 also
comprises retaining brackets 64 configured to retain needle
alignment member 52 against housing 36, while allowing sliding
motion between them when a sufficient pinching force is applied to
first and second pinch tabs 35, 36.
[0032] As shown in FIG. 4, tapered luer cone member 22 comprising a
substantially cylindrical bore cooperates with annular collar 25
having internal threads 23 disposed in spaced-apart relation to
tapered luer cone member 22 to form a luer lock connector that is
engageable with locking wedges 66 of housing 36 to provide a
fluid-tight seal between housing 36 and syringe barrel 20 whenever
needle tube 54 is coaxially aligned with barrel 20. When syringe
assembly 10 is assembled as shown in FIG. 1, a continuous fluid
flow path is formed from fluid chamber 24 (FIG. 2) through housing
36, fluid seal 44 and needle holder 46 to needle 32.
[0033] Operation of the syringe assembly 10 during filling and
injection is similar to many existing syringe and needle systems
and will be readily understood by those of ordinary skill in the
art. Referring to FIG. 5, syringe assembly 10 is shown with plunger
handle 26 advanced relative to syringe barrel 20 to the point it
will be following an injection, when plunger seal 28 has forced the
fluid out of fluid chamber 24. This is the position in which
plunger handle 26 will desirably remain relative to syringe barrel
20 during activation of the retractable needle device 30. Following
an injection, the clinician administering the injection can retract
needle 32 by pinching first pinch tab 35 toward second pinch tab
56, as illustrated in FIG. 6.
[0034] FIGS. 7 and 8 illustrate an assembled retractable needle
device 30 before (FIG. 7) and after (FIG. 8) needle 32 has
retracted. In FIG. 7 a forward end of needle holder 46 protrudes
slightly beyond the front end of needle tube 54. In FIG. 8, needle
32 and needle holder 46 have been retracted into retraction tube 42
and are no longer visible. FIG. 9 is an elevation view of the
retractable needle device 30, in retracted position, of FIG. 8.
FIG. 10 is cross-section view of the same retractable needle device
30, illustrating the arrangement of needle 32 and needle holder 46
after retraction of needle 32.
[0035] FIGS. 11 and 12 illustrate elevation and rotated
cross-sectional views of the assembled device as in FIG. 1, but
with a needle cap 70 installed to protect the needle from damage or
contamination prior to use of the device. In FIG. 12, a laterally
projecting tab 72, 74 is visible that engages the inwardly facing
side of pinch tab 56 to restrict relative movement and premature
needle retraction while needle cap 70 is in place.
[0036] Syringe engaging member 36, needle holder 46, needle
alignment member 52, syringe barrel 20 and plunger handle 26 are
all desirably moldable from a suitable moldable polymeric material.
Such materials and molding methods are believed to be well known to
those of ordinary skill in the art. Similarly, it will be
appreciated by those of skill in the art of syringe design and
manufacture that a medical device such as retractable needle device
30 disclosed here can be used with syringes that are either
pre-filled or not, and that can comprise component portions made of
glass or other suitable materials for particular applications.
Similarly, it will be appreciated that fluid seal 44 and plunger
seal 28 are desirably made of a rubbery or elastomeric polymeric
material of the types commonly known for use in such medical
applications. Similarly, it will be appreciated that materials used
in the fabrication of this and other medical devices must be
approved by the relevant regulatory authorities for use in such
devices. Needle 32 as disclosed is desirably made of stainless
steel and retraction spring 44 can be made of stainless steel or
any other similarly effective medical grade material.
[0037] Other alterations and modifications of the invention will
likewise become apparent to those of ordinary skill in the art upon
reading this specification in view of the accompanying drawings,
and it is intended that the scope of the invention disclosed herein
be limited only by the broadest interpretation of the appended
claims to which the inventors are legally entitled.
* * * * *