U.S. patent application number 10/984268 was filed with the patent office on 2005-03-31 for safety shield for medical needles.
Invention is credited to Bagley, B. Chance, Ferguson, F Mark, Snow, Jeremy W..
Application Number | 20050070855 10/984268 |
Document ID | / |
Family ID | 32710761 |
Filed Date | 2005-03-31 |
United States Patent
Application |
20050070855 |
Kind Code |
A1 |
Ferguson, F Mark ; et
al. |
March 31, 2005 |
Safety shield for medical needles
Abstract
A medical needle shield apparatus is provided that includes a
shield that is extensible from a retracted position to an extended
position to enclose a distal end of a needle. A binding member is
disposed within the shield and defines binding surfaces that form
an aperture configured for slidable receipt of the needle between
the retracted position and the extended position. The binding
member includes at least one drag inducing member extending
therefrom that is configured for slidable engagement with the
needle between the retracted position and the extended position
such that the at least one drag inducing member engages the needle
to create a drag force with the needle. The drag force causes
rotation of the binding member relative to a longitudinal axis of
the needle such that the binding surfaces engage the needle to
prevent slidable movement of the needle in the extended position of
the shield. The binding member further includes a retainer
extending therefrom such that the retainer is engageable with the
needle to prevent rotation of the binding member.
Inventors: |
Ferguson, F Mark; (Salt Lake
City, UT) ; Bagley, B. Chance; (Roy, UT) ;
Snow, Jeremy W.; (North Salt Lake, UT) |
Correspondence
Address: |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL INC.
585 WEST 500 SOUTH
BOUNTIFUL
UT
84010-8321
US
|
Family ID: |
32710761 |
Appl. No.: |
10/984268 |
Filed: |
November 8, 2004 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10984268 |
Nov 8, 2004 |
|
|
|
10322288 |
Dec 17, 2002 |
|
|
|
10984268 |
Nov 8, 2004 |
|
|
|
10202201 |
Jul 23, 2002 |
|
|
|
10202201 |
Jul 23, 2002 |
|
|
|
09809357 |
Mar 15, 2001 |
|
|
|
6595955 |
|
|
|
|
60424655 |
Nov 7, 2002 |
|
|
|
Current U.S.
Class: |
604/263 |
Current CPC
Class: |
Y10S 128/919 20130101;
A61M 2005/1581 20130101; A61M 5/3275 20130101; A61M 5/326 20130101;
A61M 5/3273 20130101; A61M 25/0625 20130101; A61M 2005/325
20130101 |
Class at
Publication: |
604/263 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A medical needle shield apparatus comprising: a shield being
extensible from a retracted position to an extended position to
enclose a distal end of a needle; and a binding member disposed
within the shield and defining binding surfaces that form an
aperture configured for slidable receipt of the needle between the
retracted position and the extended position, the binding member
including at least one drag inducing member such that the at least
one drag inducing member engages the needle during slidable receipt
of the needle to create a drag force with the needle, the drag
force facilitates rotation of the binding member relative to a
longitudinal axis of the needle such that the binding surfaces
engage the needle to prevent slidable movement of the needle in the
extended position of the shield, the binding member further
including a retainer extending therefrom such that the retainer is
engageable with the needle to prevent rotation of the binding
member.
2. A medical needle shield apparatus as recited in claim 1, wherein
the binding member includes a substantially planar aperture plate
that includes the binding surfaces that form the aperture.
3. A medical needle shield apparatus as recited in claim 2, wherein
the aperture plate is substantially perpendicular relative the
longitudinal axis of the needle due to engagement of the retainer
with the needle when not in the extended position.
4. A medical needle shield apparatus as recited in claim 1, wherein
the retainer includes a first portion extending from the binding
member and a second portion extending from the first portion.
5. A medical needle shield apparatus as recited in claim 4, wherein
the first portion extends from the binding member in substantially
parallel alignment with the needle due to engagement of the
retainer with the needle.
6. A medical needle shield apparatus as recited in claim 4, wherein
the second portion extends transversely relative to the
longitudinal axis of the needle and is configured for engagement
with the needle.
7. A medical needle shield apparatus as recited in claim 6, wherein
the second portion has a substantially planar portion for
engagement with the needle.
8. A medical needle shield apparatus as recited in claim 7, wherein
the substantially planar portion of the second portion defines a
retainer cavity.
9. A medical needle shield apparatus as recited in claim 1, wherein
the at least one drag inducing member includes the aperture of the
binding member such that the aperture engages the needle to create
the drag force with the needle.
10. A medical needle shield apparatus as recited in claim 1,
wherein the at least one drag inducing member includes a pair of
friction members that extend to engage the needle to create the
drag force with the needle.
11. A medical needle shield apparatus as recited in claim 10,
wherein the pair of friction members defines a cavity that is
substantially aligned with the aperture, the cavity being
configured for slidable receipt of the needle to create the drag
force with the needle.
12. A medical needle shield apparatus as recited in claim 1,
wherein the at least one drag inducing member includes at least one
friction member disposed on the needle.
13. A medical needle shield apparatus as recited in claim 1,
wherein the at least one drag inducing member is integral to the
binding member.
14. A medical needle shield apparatus as recited in claim 1,
wherein the at least one drag inducing member includes a unitary
friction element disposed on the medical needle.
15. A medical needle shield apparatus as recited in claim 14,
wherein the unitary friction element includes friction elements for
canting the binding member and the aperture of the binding member
is disposed between the friction elements.
16. A medical needle shield apparatus as recited in claim 1,
wherein the retainer includes a slot to release a guidewire.
17. A medical needle shield apparatus as recited in claim 1,
wherein the binding member is rotatable, relative to the
longitudinal axis of the needle, between a non-binding orientation
whereby the needle is slidable relative to the binding member and a
binding orientation whereby the binding surfaces engage the needle
to prevent slidable movement of the needle in the extended position
of the shield.
18. A medical needle shield apparatus as recited in claim 17,
wherein the shield includes a housing that defines at least one
blocking member extending from an interior surface thereof, the at
least one blocking member being engageable with the binding member
for urging the binding member to the binding orientation.
19. A medical needle shield apparatus as recited in claim 1,
further comprising an outer rotatable housing that encloses the
shield, the outer rotatable housing supporting the shield for
relative rotational movement therewith.
20. A medical needle shield apparatus as recited in claim 19,
wherein the shield is supported for relative rotational movement by
the outer rotatable housing by at least one bearing.
21. A medical needle shield apparatus as recited in claim 1,
wherein the shield is positioned to indicate needle insertion
depth.
22. A medical needle shield apparatus as recited in claim 1,
further comprising a means for extending the shield to the distal
end of the needle.
23. A medical needle shield apparatus comprising: a shield being
extensible from a retracted position to an extended position to
enclose a distal end of a needle; and a binding member disposed
within the shield and including an aperture for slidable receipt of
the needle between the retracted position and the extended
position, the binding member defining a drag inducing means for
facilitating rotation of the binding member relative to a
longitudinal axis of the needle by frictional drag forces between
the drag inducing means and needle, and a binding surface means for
engaging the needle to prevent slidable movement of the needle in
the extended position of the shield, the binding member further
including a retainer means for preventing rotation of the binding
member.
24. A medical needle shield apparatus as recited in claim 23,
wherein the binding member is rotatable, relative to the
longitudinal axis of the needle, between a non-binding orientation
whereby the needle is slidable relative to the binding member and a
binding orientation whereby the binding surface means engages the
needle to prevent slidable movement of the needle in the extended
position of the shield.
25. A medical needle shield apparatus as recited in claim 23,
further comprising an outer rotatable housing that encloses the
shield, the outer rotatable housing supporting the shield for
relative rotational movement therewith in the extended position of
the shield.
26. A medical needle shield apparatus as recited in claim 25,
wherein the shield is supported for relative rotational movement by
the outer rotatable housing by at least one bearing.
27. A medical needle shield apparatus as recited in claim 23,
wherein the at least one drag inducing member includes at least one
friction member disposed on the needle.
28. A medical needle shield apparatus as recited in claim 23,
wherein the at least one drag inducing member is integral to the
binding member.
29. A medical needle shield apparatus as recited in claim 23,
wherein the at least one drag inducing member includes a unitary
friction element disposed on the medical needle.
30. A medical needle shield apparatus as recited in claim 29,
wherein the unitary friction element includes friction elements for
canting the binding member and the aperture of the binding member
is disposed between the friction elements.
31. A medical needle shield apparatus as recited in claim 23,
wherein the retainer includes a slot to release a guidewire.
32. A medical needle shield apparatus as recited in claim 23,
further comprising a means for extending the shield to the distal
end of the needle.
33. A medical needle shield apparatus comprising: a shield being
extensible from a retracted position to an extended position to
enclose a distal end of a needle; a binding member disposed within
the shield and defining binding surfaces that form an aperture
configured for slidable receipt of the needle between the retracted
position and the extended position, the binding member being
rotatable, relative to a longitudinal axis of the needle, between a
non-binding orientation whereby the needle is slidable relative to
the binding member and a binding orientation whereby the binding
surfaces engage the needle to prevent slidable movement of the
needle in the extended position of the shield, the binding member
including a pair of drag inducing members that extend to define a
cavity that is substantially aligned with the aperture, the cavity
being configured for slidable receipt of the needle between the
retracted position and the extended position such that the drag
inducing members create a drag force with the needle, the drag
force facilitating rotation of the binding member relative to the
longitudinal axis of the needle to the binding orientation, the
binding member further including a retainer extending therefrom,
the retainer including a first portion extending from the binding
member and a second portion extending from the first portion, such
that the second portion is engageable with the needle to prevent
rotation of the binding member; and an outer rotatable housing that
encloses the shield, the outer rotatable housing supporting the
shield for relative rotational movement therewith in the extended
position of the shield, the shield being supported for relative
rotational movement by the outer rotatable housing by at least one
bearing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 10/322,288, filed on Dec. 17, 2002 by Ferguson et al.,
which is a continuation-in-part of U.S. Provisional Patent
application Ser. No. 60/424,655, filed in the U.S. Patent and
Trademark Office on Nov. 7, 2002 by Bagley et al., and U.S. Utility
patent application Ser. No. 10/202,201, filed in the U.S. Patent
and Trademark Office on Jul. 23, 2002 by Ferguson, which is a
continuation-in-part of U.S. Utility patent application Ser. No.
09/809,357, filed in the U.S. Patent and Trademark Office on Mar.
15, 2001 by Ferguson et al., the entire contents of each of these
disclosures being hereby incorporated by reference herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure generally relates to safety shields
for medical needles, and more particularly, to safety shields that
protect a needle point of a medical needle.
[0004] 2. Description of the Related Art
[0005] Problems associated with inadvertent needle sticks are well
known in the art of blood sampling, percutaneous medication
injection and other medical procedures involving use of medical
needles. Significant attention has been focused on needle stick
problems due to the contemporary sensitivity of exposure to AIDS,
Hepatitis and other serious blood-borne pathogen exposures.
[0006] Procedures for removing a needle from a patient commonly
require a technician to use one hand to place pressure at the wound
site where the needle is being withdrawn, while removing the needle
device with the other hand. It is also common practice for an
attending technician to give higher priority to care for the wound
than is given to disposal of a needle. In the case of typical
needle devices without safety shields, such priority either
requires the convenience of an available sharps container within
reach or another means for safe disposal without leaving the
patient's side. Providing adequate care while following safety
procedures is often compounded by the patient's physical condition
and mental state, such as in burn units and psychiatric wards.
Under such conditions, it is difficult to properly dispose of a
used needle while caring for a patient.
[0007] The widespread knowledge and history associated with needle
care and disposal problems have resulted in numerous devices for
preventing accidental needle sticks. Problems of current safety
devices include difficulty of use and high cost due to their
complexity and number of parts.
[0008] Other known devices employ sheaths that are spring
activated, telescoping, pivoting, etc. These devices, however, may
disadvantageously misfire or be cumbersome to activate. Further
drawbacks of current devices include high manufacturing cost due to
complexity and the number of parts. Thus, these type prior art
devices may not adequately and reliably shield medical needle
apparatus to prevent hazardous exposure.
[0009] Consequently, there remains a need to provide a more
satisfactory solution for needle safety devices by overcoming the
disadvantages and drawbacks of the prior art. Therefore, it would
be desirable to provide a more adequate and reliable medical needle
shield apparatus which employs a safety shield slidably movable
along a medical needle to prevent hazardous exposure to a needle
tip. Such a needle shield apparatus should be easily and reliably
movable to shield a needle tip of a needle cannula.
SUMMARY
[0010] Accordingly, the present disclosure addresses a need for a
medical needle shield apparatus which effectively and inexpensively
protects a tip of a medical needle after use. The present
disclosure resolves related disadvantages and drawbacks experienced
in the art. More specifically, the apparatus and method of this
invention constitute an important advance in the art of safety
needle devices.
[0011] In one particular embodiment, a medical needle shield
apparatus is provided in accordance with the principles of the
present disclosure. The medical needle shield apparatus includes a
shield that is extensible from a retracted position to an extended
position to enclose a distal end of a needle. A binding member is
disposed within the shield and defines binding surfaces that form
an aperture configured for slidable receipt of the needle between
the retracted position and the extended position. The binding
member includes at least one drag inducing member that is
configured for slidable engagement with the needle between the
retracted position and the extended position such that the at least
one drag inducing member engages the needle to create a drag force
with the needle. The drag force facilitates rotation, as will be
discussed, of the binding member relative to a longitudinal axis of
the needle such that the binding surfaces engage the needle to
prevent slidable movement of the needle in the extended position of
the shield. The binding member further includes a retainer
extending therefrom such that the retainer is engageable with the
needle to prevent rotation of the binding member.
[0012] The binding member may include a substantially planar
aperture plate that has the binding surfaces that form the
aperture. The aperture plate may be substantially perpendicular
relative to the longitudinal axis of the needle due to engagement
of the retainer with the needle.
[0013] Alternatively, the retainer includes a first portion
extending from the binding member and a second portion extending
from the first portion. The first portion can extend from the
binding member in substantially parallel alignment with the needle
due to engagement of the retainer with the needle. The second
portion can extend transversely relative to the longitudinal axis
of the needle and is configured for engagement with the needle. The
second portion may have a substantially planar portion for
engagement with the needle. The substantially planar portion of the
second portion may define a retainer cavity.
[0014] The at least one drag inducing member may include the
aperture of the binding member such that the aperture engages the
needle to create the drag force with the needle. The at least one
drag inducing member may include a pair of friction members that
extend to engage the needle to create the drag force with the
needle. The pair of friction members may define a cavity that is
substantially aligned with the aperture. The cavity is configured
for slidable receipt of the needle to create the drag force with
the needle.
[0015] Alternatively, the binding member is rotatable, relative to
the longitudinal axis of the needle, between a non-binding
orientation whereby the needle is slidable relative to the binding
member and a binding orientation whereby the binding surfaces
engage the needle to prevent slidable movement of the needle in the
extended position of the shield. The shield may include a housing
that defines at least one blocking member extending from an
interior surface thereof. The at least one blocking member is
engageable with the binding member for urging the binding member to
the binding orientation.
[0016] In an alternate embodiment, the medical needle shield
apparatus includes an outer rotatable housing that encloses the
shield. The outer rotatable housing supports the shield for
relative rotational movement therewith in the extended position of
the shield. The shield may be supported for relative rotational
movement by the outer rotatable housing by at least one
bearing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The foregoing and other features and advantages of the
present invention will be more fully understood from the following
detailed description of the exemplary embodiments, taken in
conjunction with the accompanying drawings in which:
[0018] FIG. 1 is a perspective view of one particular embodiment of
a medical needle shield apparatus in accordance with the principles
of the present disclosure;
[0019] FIG. 2 is a cutaway perspective view of a shield and a
needle, in a non-binding orientation, of the medical needle shield
apparatus shown in FIG. 1 with a housing section separated;
[0020] FIG. 3 is a cutaway perspective view of the shield and the
needle, in a binding orientation, of the medical needle shield
apparatus shown in FIG. 1 with the housing section separated;
[0021] FIG. 4 is an enlarged perspective view of a binding member
of the medical needle shield apparatus shown in FIG. 1;
[0022] FIG. 5 is an enlarged perspective view of an alternate
embodiment of the binding member shown in FIG. 4;
[0023] FIG. 6 is an enlarged perspective view of another alternate
embodiment of the binding member shown in FIG. 4;
[0024] FIG. 6A is an enlarged perspective view of another alternate
embodiment of the binding member shown in FIG. 4;
[0025] FIG. 6B is an enlarged perspective view of another alternate
embodiment of the binding member shown in FIG. 4;
[0026] FIG. 7 is a cutaway perspective view of the shield and the
needle of the medical needle shield apparatus shown in FIG. 1
employing the binding member shown in FIG. 6;
[0027] FIG. 8 is an enlarged perspective view of an alternate
embodiment of the shield shown in FIG. 2, with a housing section
removed;
[0028] FIG. 9 is a cutaway perspective view of the medical needle
shield apparatus shown in FIG. 1 with an outer rotatable housing
mounted with the shield and the needle;
[0029] FIG. 10 is a cutaway perspective view of the shield, needle
and the outer rotatable housing shown in FIG. 9 with parts
separated;
[0030] FIG. 11 is a perspective view of the medical needle shield
apparatus shown in FIG. 9, in the retracted position;
[0031] FIG. 12 is a perspective view of the medical needle shield
apparatus shown in FIG. 9, in the extended position;
[0032] FIG. 13 is a cutaway perspective view of an alternate
embodiment of the medical needle shield apparatus shown in FIG. 9
with parts separated;
[0033] FIG. 14 is a cutaway perspective view of another alternate
embodiment of the medical needle shield apparatus shown in FIG. 9
with parts separated;
[0034] FIG. 15 is an enlarged perspective view of an alternate
embodiment of the shield shown in FIG. 2, with a housing section
removed;
[0035] FIG. 16 is an enlarged perspective view of an alternate
embodiment of the shield shown in FIG. 2, with a housing section
removed;
[0036] FIG. 17 is a perspective view of an alternate embodiment of
the shield shown in FIG. 1 on a syringe in the pre-activation
state; and
[0037] FIG. 18 is a perspective view of the embodiment shown in
FIG. 17 in the post-activation state.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0038] The exemplary embodiments of the medical needle shield
apparatus and methods of operation disclosed are discussed in terms
of medical needles for infusion of intravenous fluids, medication
infusion or fluid collection, and more particularly, in terms of
needle shield apparatus employed with a needle cannula that prevent
hazardous exposure to the needle tip, including, for example,
inadvertent needle sticks. It is envisioned that the present
disclosure, however, finds application to a wide variety of cannula
needles and devices for the infusion of preventive medications,
medicaments, therapeutics, etc. to a subject. It is also envisioned
that the present disclosure may be employed for collection of body
fluids including those employed during procedures relating to
phlebotomy, digestive, intestinal, urinary, veterinary, etc. It is
contemplated that the medical needle shield apparatus may be
utilized with other medical needle applications including, but not
limited to, fluid infusion, fluid collection, catheters, catheter
introducers, guidewire introducers, spinal and epidural, biopsy,
aphaeresis, dialysis, blood donor, Veress needles, Huber needles,
etc.
[0039] In the discussion that follows, the term "proximal" refers
to a portion of a structure that is closer to a clinician, and the
term "distal" refers to a portion that is further from the
clinician. As used herein, the term "subject" refers to a patient
that receives infusions or has blood and/or fluid collected
therefrom using the medical needle shield apparatus. According to
the present disclosure, the term "clinician" refers to an
individual administering an infusion, performing fluid collection,
installing or removing a needle cannula from a medical needle
shield apparatus and may include support personnel.
[0040] The following discussion includes a description of the
medical needle shield apparatus, followed by a description of the
method of operating the medical needle shield apparatus in
accordance with the present disclosure. Reference will now be made
in detail to the exemplary embodiments of the disclosure, which are
illustrated in the accompanying figures.
[0041] Turning now to the figures, wherein like components are
designated by like reference numerals throughout the several views.
Referring initially to FIGS. 1-4, there is illustrated a medical
needle shield apparatus, constructed in accordance with the
principals of the present disclosure. The medical needle shield
apparatus includes a shield 10 that is extensible from a retracted
position (FIG. 1) to an extended position (FIG. 3) to enclose a
distal end 14 of a needle such as, for example, elongated needle
cannula 16.
[0042] A binding member 64 is disposed within shield 10 and defines
binding surfaces 68. Binding surfaces 68 form an aperture 66
configured for slidable receipt of needle cannula 16 between the
retracted position and the extended position. Binding member 64
includes a drag inducing member, such as, for example, friction
members 62 extending therefrom. Binding member 64 includes a
retainer 70 extending therefrom. Retainer 70 is engageable with
needle cannula 16 to prevent rotation of binding member 64.
Friction members 62 are configured for slidable engagement with
needle cannula 16 between the retracted position and the extended
position such that friction members 62 engage needle cannula 16 to
create a drag force with needle cannula 16. It is envisioned that
one or a plurality of friction members 62 may be employed. The drag
force in conjunction with one of the blocking members 40 or 42,
cause binding member 64 to move to the binding position. Note that
the force created by blocking member 40 or 42 acts in a direction
opposite of the drag force. This causes a force couple, which moves
the binding member 64 to the binding position. As needle 16 is
released from engagement with needle communicating surface 72,
binding member 64 and retainer 70 move to the binding position.
Rotation is no longer opposed by engagement with needle 16 at
needle communicating surface 72. Thus, binding member 64, attached
to retainer 70, is subject to inclination into a binding
orientation. Rotation of binding member 64 causes binding surfaces
68 to frictionally engage needle 16 to prevent movement thereof.
Blocking member 40 or 42 cause binding member 64 to move to the
binding position as forces are imposed on shield 10 in either
direction along longitudinal axis x. This maintains needle 16
within shield 10 to avoid hazardous exposure to distal end 14. It
is envisioned that needle communicating surface 72 may include
ribs, projections, cavities, etc. for engagement with needle 16 or
that a portion of needle communicating surface 72 engages needle
16.
[0043] The components of the medical needle shield apparatus can be
fabricated from a material suitable for medical applications, such
as, for example, polymerics or metals, such as stainless steel,
depending on the particular medical application and/or preference
of a clinician. Semi-rigid and rigid polymerics are contemplated
for fabrication, as well as resilient materials, such as molded
medical grade polypropylene. However, one skilled in the art will
realize that other materials and fabrication methods suitable for
assembly and manufacture, in accordance with the present
disclosure, also would be appropriate.
[0044] Shield 10 includes a housing 12 that encloses binding member
64. Housing 12 includes a housing first section 28 and a housing
second section 30. It is envisioned that housing sections 28, 30
may be variously configured and dimensioned such as, for example,
rectangular, spherical, etc. It is further envisioned that housing
sections 28, 30 may be joined by any appropriate process such as,
for example, snap fit, adhesive, solvent weld, thermal weld,
ultrasonic weld, screw, rivet, etc. Alternatively, housing 12 may
be monolithically formed or integrally assembled of multiple
housing sections and may be substantially transparent, opaque, etc.
Housing sections 28 may include ribs, ridges, etc. to facilitate
manipulation of the medical needle shield apparatus.
[0045] Housing 12 includes openings 44, disposed at proximal and
distal end thereof, that are configured and dimensioned to allow
needle cannula 16 to freely pass through. In the retracted
position, shield 10 is disposed adjacent to a hub 32 of a medical
needle. The medical needle may include a stylet 34 within the bore
of the needle. It is contemplated that the components of the
medical needle apparatus may be employed with other needle
applications, such as, for example, catheters, guidewire
introducers, such as a Seldinger needle, etc.
[0046] Binding member 64 may be monolithically formed and includes
an aperture plate 65, frictional members 62, and retainer 70, which
includes end sensing member 71 and needle communicating surface 72.
It is contemplated that binding member 64 may include one or more
frictional members 62. Aperture plate 65 has a rectangular,
generally planar configuration with sufficient stiffness to produce
forces for binding needle cannula 16, as will be discussed. It is
envisioned that aperture plate 65 may have an arcuate surface,
undulating, etc. It is further envisioned that aperture plate 65
may have various degrees of stiffness according to the requirements
of a particular application.
[0047] Frictional members 62 may be monolithically formed with
binding member 64 and extend from aperture plate 65 in association
therewith for alignment with aperture 66 and engagement with needle
cannula 16. Each frictional member 62 includes a flexible arm 62A,
which are spaced apart to facilitate sliding engagement with needle
cannula 16. Such engagement creates a frictional drag force with
needle cannula 16. This frictional drag force in conjunction with
one of the blocking members 40 or 42 causes binding member 64 to
move with needle cannula 16, which generates a canting force in
retainer 70 and inclination of aperture plate 65. The canting force
and inclination urge rotation of binding member 64. It is
contemplated that a single friction member may be employed. It is
further contemplated that frictional members 62 may have flexible
portions, which may be of varying flexibility according to the
particular requirements of a needle application.
[0048] As facilitated by movement of needle cannula 16, the canting
force causes a lever or moment of retainer 70, which is opposed to
prevent rotation of binding member 64. The canting force is opposed
by engagement of needle communicating surface 72 with needle
cannula 16 in a non-binding or sliding orientation of binding
member 64.
[0049] End sensing member 71 extends distally from aperture plate
65, parallel to needle cannula 16. End sensing member 71 may be
perpendicularly oriented relative to a plane defined by aperture
plate 65. This perpendicular orientation facilitates inclination of
aperture plate 64 for disposal in a binding or non-binding
orientation of binding member 64. It is envisioned that end sensing
member 71 may be variously oriented with aperture plate 65 and may
flexibly extend therefrom.
[0050] Needle communicating surface 72 opposes the canting force of
end sensing member 71 directed to needle cannula 16. The canting
force is generated by friction members 62 in conjunction with one
of the blocking members 40 or 42 and facilitates inclination of
aperture plate 65. Inclination, however, is prevented in the
non-binding or sliding orientation because of the engagement of
needle communicating surface 72 with needle cannula 16. As needle
cannula 16 is retracted proximally and shield 10 is extended
distally, needle cannula 16 continues to slideably engage needle
communicating surface 72.
[0051] As needle cannula 16 is released from engagement with needle
communicating surface 72, as shown in FIG. 3, a drag force is
created between friction members 62 and needle cannula 16. The drag
force in conjunction with blocking member 42, cause aperture plate
65 to move to the binding position. Note that the force created by
blocking member 42 acts in a direction opposite of the drag force.
This causes a force couple which moves the aperture plate 65 to the
binding position. As needle cannula 16 is released from engagement
with the needle communicating surface 72, aperture plate 65 moves
to the binding position. Rotation is no longer opposed by
engagement with needle cannula 16 at needle communicating surface
72. Thus, aperture plate 65, attached to retainer 70, is subject to
inclination into a binding orientation. Rotation of aperture plate
65 causes binding surfaces 68 to frictionally engage needle cannula
16 to prevent movement thereof. Blocking members 40, 42 cause
aperture plate 65 to move to the binding position as forces are
imposed on shield 10 in either direction along longitudinal axis x.
This maintains needle cannula 16 within shield 10 to avoid
hazardous exposure to distal end 14. It is further envisioned that
needle communicating surface 72 may include ribs, projections,
cavities, etc. for engagement with needle cannula 16 or that a
portion of needle communicating surface 72 engages needle cannula
16.
[0052] Aperture 66 is formed within aperture plate 65 for slidable
engagement with needle cannula 16 during movement between the
retracted position and the extended position of shield 10. Aperture
66 includes binding surfaces 68 formed on opposing sides of
aperture 66 that engage needle cannula 16 to prevent movement
thereof in the extended position of shield 10. It is contemplated
that engagement to prevent movement of needle cannula 16 may
include penetrating, frictional, interference, etc. It is
envisioned that aperture 66 may have various geometric
configurations, such as radial, polygonal, etc. It is further
envisioned that aperture 66 may define an open cavity within
aperture plate 65, such as, for example, "U" shaped and open to one
or a plurality of edges of aperture plate 65.
[0053] The inclination of aperture plate 65 relative to
longitudinal axis x facilitates sliding and binding, via binding
surfaces 68 of aperture 66, of needle cannula 16 within shield 10
to prevent hazardous exposure to distal end 14. For example, as
shown in FIG. 2, aperture plate 65 is oriented at an angle of
approximately 90.degree. relative to longitudinal axis x such that
aperture plate 65 is disposed substantially perpendicular to needle
cannula 16. In this non-binding or sliding orientation, needle
cannula 16 is free to slide within aperture 66. As needle cannula
16 is retracted and shield 10 is extended, needle cannula 16
continues to engage needle communicating surface 72 and aperture
plate 65 maintains its perpendicular orientation relative to
longitudinal axis x.
[0054] Referring to FIG. 3, shield 10 is manipulated such that
friction members 62 in conjunction with blocking member 42 cause
binding member 64 to rotate relative to longitudinal axis x.
Aperture plate 65 rotates out of perpendicular alignment with
needle cannula 16 such that aperture plate 65 is oriented at an
angle .alpha., which is less than 90.degree. with respect to
longitudinal axis x. It is contemplated that angle .alpha. may be
measured from either side of aperture plate 65.
[0055] Aperture plate 65 rotates to angle .alpha. and binding
member 64 approaches a binding orientation. The binding orientation
includes engagement of binding surfaces 68 with needle cannula 16
due to the binding orientation of aperture plate 65. This
engagement creates binding frictional forces on needle cannula 16,
in conjunction with frictional members 62 and blocking members 40,
42 to prevent movement of needle cannula 16 relative to shield 10
in both distal and proximal directions, and to maintain distal end
14 within shield 10 to prevent hazardous exposure thereto. Blocking
members 40, 42 may be formed with one or both of housing sections
28 and 30, and are disposed not to interfere with needle cannula
16. Blocking members 40, 42 define surfaces 40A, 42A respectively,
that facilitate disposal of aperture plate 65 in a binding
orientation.
[0056] For example, as shown in FIG. 2, shield 10 is in a retracted
position and needle cannula 16 is fully extended. Binding member 64
and aperture plate 65 are in a non-binding or sliding orientation
such that aperture plate 65 is substantially perpendicular to
longitudinal axis x. Blocking members 40, 42 may engage aperture
plate 65 to maintain aperture plate 65 in the perpendicular
orientation. Blocking members 40, 42 may also maintain such
orientation during extension of needle cannula 16 or may not engage
needle cannula 16.
[0057] As needle cannula 16 is retracted and shield 10 is extended,
friction members 62 create a drag force via engagement with needle
cannula 16 on binding member 64 and in conjunction with blocking
member 42 cause aperture plate 65 to rotate in a counter-clockwise
direction to the binding orientation. Blocking member surfaces 40A,
42A engage aperture plate 65 to facilitate rotation thereof from
the perpendicular orientation into the binding orientation such
that binding surfaces 68 engage needle cannula 16. This
configuration prevents movement of needle cannula 16.
[0058] Housing 12 may also include needle supports 38 that guide
needle cannula 16 during axial movement thereof. Needle supports 38
laterally engage needle cannula 16 to maintain axial alignment
during passage through shield 10. It is envisioned that one or a
plurality of needle supports 38 may be used. It is further
envisioned that needle supports 38 may define cavities, etc. for
slidable receipt of needle cannula 16. Needle Supports 38 may be
monolithically formed in conjunction with blocking members
40,42.
[0059] Binding of binding member 64 to needle cannula 16 is
facilitated by the friction force generated between binding
surfaces 68 and needle cannula 16. This frictional engagement
prevents axial movement of needle cannula 16 relative to housing 12
when shield 10 is in the extended position. This configuration
advantageously prevents hazardous exposure to needle cannula 16. It
is contemplated that binding surfaces 68 may include sharp edges to
increase frictional engagement. It is further contemplated that the
binding friction force may be varied by altering factors, such as,
for example, aperture 66 dimension, needle cannula 16 diameter,
aperture plate 65 thickness, the dimension from blocking members
40, 42 contact point to the centerline of needle cannula 16 and the
coefficient of friction between aperture 66 and needle cannula 16
depending on the particular requirements of a needle application.
It is envisioned that the friction members 62 may be configured so
as to vary the drag force with variation of the inclination of the
aperture plate 65, this variation in drag force may be accomplished
by geometric changes in the shape of the friction members 62, such
as wedge shapes or the inclusion of notches to engage the needle
16, this variation in drag force may also be accomplished through
the selective application of friction modifying materials or
coatings such as oils, greases, or coatings which increase
friction.
[0060] Referring to FIG. 5, an alternate embodiment of binding
member 64 is shown. Retainer 70 includes a needle communicating
surface 172. Needle communicating surface 172 defines a slot 146
that supportingly engages needle cannula 146. It is contemplated
that slot 146 is configured and dimensioned to release a guidewire,
which passes through needle cannula 16, both of which pass through
shield 10. Slot 146 engages needle cannula 16 and maintains the
non-binding or sliding orientation of aperture plate 65 by opposing
the canting force of end sensing member 71. Slot 146 may be sized
such that the guidewire is not capable of engaging the end sensing
member such that as needle cannula 16 is released from engagement
with slot 146, sensing member 71 is free to rotate with binding
member 64 to the binding orientation unhindered by the
guidewire.
[0061] Referring to FIGS. 6 and 7, another alternate embodiment of
binding member 64 is shown. Binding member 64 includes a drag
inducing member, such as aperture 166 that is formed by binding
surfaces 168. Aperture 166 facilitates sliding engagement with
needle cannula 16. Such engagement creates a frictional drag force
with needle cannula 16. This frictional drag force in conjunction
with blocking member 42 causes binding member 64 to move with
needle cannula 16. In a non-binding or sliding orientation of
binding member 64, aperture plate 65 engages one of the blocking
members 40, 42 causing a canting force in end sensing member 71, as
discussed.
[0062] Retainer 70 includes a needle communicating surface 172,
similar to that described with regard to FIG. 5, which opposes the
canting force of end sensing member 71. Slot 146 engages and
maintains needle cannula 16 in the non-binding or sliding
orientation. As needle cannula 16 is released from engagement with
slot 146, binding member 64 is caused to rotate as facilitated by
one of the blocking members 40, 42, counter-clockwise to the
binding orientation. Binding of binding member 64 to needle cannula
16 is facilitated by the friction force generated between binding
surfaces 168 and needle cannula 16. This frictional engagement
prevents axial movement of needle cannula 16 in the extended
position and prevents hazardous exposure thereto.
[0063] Referring to FIGS. 6A and 6B, alternate embodiments of
binding member 64 are shown. FIG. 6A shows a member 174 having a
drag opening 175, with member 174 being disposed on binding member
64. The diameter of drag opening 175 is sized so as to create a
drag force in conjunction with the needle 16 and in conjunction
with one of the blocking members 40 or 42, causing binding member
64 to move to the binding position. It is contemplated that members
174 and 177 may be fabricated from materials such as polymerics,
metals, elastomeric materials, etc.
[0064] FIG. 6B shows a member 177 having elements 178 defining an
opening 180, with member 177 being disposed on binding plate 64.
Member 177 includes a drag inducing member, such as opening 180
that is formed by surfaces 179. The distance between surfaces 179
is sized so as to create a drag force in conjunction with the
needle 16. Surfaces 179 facilitate sliding engagement with needle
cannula 16. Such engagement creates a frictional drag force with
needle cannula 16, and in conjunction with one of the blocking
members 42 or 43, causing binding member 64 to move to the binding
position. It is contemplated that members 174 and 177 may be
fabricated from materials such as polymerics, metals, elastomeric
materials, etc.
[0065] Referring to FIG. 8, an alternate embodiment of housing 12
is shown. Housing 12 includes a plate support surface 200. Plate
support surface 200 is formed with one or both housing sections 28,
30. Plate support surface 200 is oriented at an angle relative to
longitudinal axis x. Plate support surface 200 is oriented such
that, subsequent to binding needle cannula 16 with binding surfaces
68, surface 200 engages aperture plate 65 to prevent structural
failure of binding member 64 in the binding orientation. Structural
failure of aperture plate 65 includes elastic flexing, plastic
failure, etc. It is contemplated that plate support surface 200 may
be oriented at various angles, such as, for example, 35-40 degrees.
It is further contemplated that plate support surface 200 may be
monolithically formed or integrally assembled with housing 12.
[0066] In operation, the medical needle shield apparatus, similar
to that described in accordance with the principles of the present
disclosure is provided for employment with stylet 34. Other needle
applications and methods of use are also contemplated. The
components of the medical needle shield apparatus are fabricated,
properly sterilized and otherwise prepared for storage, shipment
and use. The medical needle shield apparatus may be manipulated by
a handle and a removable sheath may be mounted therewith to enclose
the components of the medical needle shield apparatus via friction,
snap fit, interference fit, etc.
[0067] Referring to FIG. 1, the clinician (not shown) manipulates
the medical needle shield apparatus such that shield 10 is in the
retracted position and binding member 64 is in a non-binding or
sliding orientation. Needle cannula 16 is fully extended relative
to shield 10. A procedure employing the medical needle shield
apparatus with stylet 34 is performed by the clinician to
completion.
[0068] Needle cannula 16 is retracted proximally such that shield
10 is extended toward the extended position, as shown in FIG. 2.
Binding member 64 is in the non-binding or sliding orientation such
needle cannula 16 engages needle communicating surface 72 and
binding surfaces 68 facilitate sliding through aperture 66, as
discussed.
[0069] Referring to FIG. 3, as needle cannula 16 clears needle
communicating surface 72, retainer 70 is free to rotate due to the
canting forces created via the engagement of needle cannula 16 with
frictional members 62. Aperture plate 65 rotates counter-clockwise,
relative to longitudinal axis x, from the perpendicular orientation
to an inclination for a binding orientation as facilitated by
blocking members 40, 42. Aperture plate 65 rotates to angle .alpha.
relative to longitudinal axis x.
[0070] In the binding orientation, binding surfaces 68 engage
needle cannula 16 to bind and prevent axial movement of needle
cannula 16 within housing 12 and lock the medical needle shield
apparatus in a protective configuration. Shield 10 is disposed in
the extended position to prevent hazardous exposure to distal end
14.
[0071] In an alternate embodiment, as shown in FIG. 15, binding
member 64' includes separate friction members 190 that are disposed
on a proximal side and a distal side of aperture plate 65',
respectively. Friction members 190 are friction fit polymer
O-rings, which allow sliding of needle 16 therewith and provide a
frictional drag force, similar to that discussed, via engagement
with needle 16. The drag force is created as needle 16 slides and
friction members 190 engage aperture plate 65'. Friction members
190 engage aperture plate 65', and in conjunction with blocking
member 42, cause aperture plate 65' to move to the binding
position. Binding surfaces 68 engage needle 16 to prevent axial
movement of needle 16, as discussed. It is contemplated that
friction members 190 may be fabricated from materials such as
polymerics, metals, etc. It is also contemplated that the friction
members 190 may have other shapes, including square, polygonal,
ovoid etc.
[0072] Alternatively, friction members 190 may form a monolithic
member 191 that links or joins two members 192, as shown in FIG.
16. Members 192 engage needle 16 and aperture plate 65' to prevent
axial movement of needle 16, similar to that discussed with regard
to FIG. 15. The drag force is created as needle 16 slides and
friction members 192 engage aperture plate 65'. Friction members
192 engage aperture plate 65', and in conjunction with blocking
member 42, cause aperture plate 65' to move to the binding
position. Binding surfaces 68 engage needle 16 to prevent axial
movement of needle 16, as discussed. It is further envisioned that
materials such as, for example, jells, greases, etc. may be
employed to create a frictional drag force with needle 16 to cause
rotation of aperture plate 65'.
[0073] Referring to FIGS. 9-12, an alternate embodiment of the
medical needle safety apparatus is shown. An outer rotatable
housing 100, having sections 101, is disposed for rotation about
and enclosure of shield 10 in the retracted position, as shown in
FIG. 11. Outer rotatable housing 100 is mounted with shield 10, and
freely rotates relative to shield 10 and needle cannula 16 in the
extended position of shield 10, as shown in FIG. 12. Relative
rotation of outer rotatable housing 100 is facilitated by support
at opening 102 and opening 105 formed in outer rotatable housing
100. Openings 102, 105 support needle cannula 16 and facilitate
free slidable rotation therein.
[0074] Outer rotatable housing 100 includes a bearing 103 that
rotationally supports an axle 104 of housing 12, at corresponding
distal ends thereof. This configuration advantageously limits
radial engagement of shield 10 with outer rotatable housing 100. In
a binding orientation, the bearing configuration and openings 102,
105 support rotation of outer rotatable housing 100 relative to
shield 10 and needle cannula 16. Housing 12 includes blocking
members 40, 42, similar to those discussed. It is envisioned that a
bearing and axle similar to that comprised of 103 and 104 at the
distal end of the shield may be formed at the proximal end of the
shield.
[0075] This configuration prevents rotation of shield 10 about
longitudinal axis x of needle cannula 16 such that binding member
64 is not undesirably rotated to disturb the protective binding
engagement with needle cannula 16. Thus, the possibility of
intentionally abusing and defeating the protective configuration of
shield 10, in the extended position, by manually and abusively
twisting shield 10 is reduced. In an alternate embodiment, as shown
in FIG. 13, The bearing 103 and axle 104 may be deleted, and the
length of opening 105 is increased such that the radial clearance
of opening 105 with needle cannula 16 limits tilting of the needle
16, and thereby the shield 10 within outer rotatable housing 100.
This configuration prevents radial contact of shield 10 with outer
rotatable housing 100.
[0076] Referring to FIG. 14, in another alternate embodiment, a
housing 112 has a unitary body, eliminating the configuration
employing separate housing sections. Housing 112 is mounted within
outer rotatable housing 100 which is comprised of sections 101, and
supports binding member 64 and needle cannula 16. It is envisioned
that housing 112 may also incorporate blocking members 40, 42 and
needle supports 38. It is further envisioned that housing 112 is
monolithically formed. Housing 112 includes openings 112A for
access to an interior thereof.
[0077] FIGS. 17 and 18 illustrate the safety shield assembly 10
disposed on a medical needle device 204, which includes a stored
energy means, such as spring 200, for moving the shield 12 from a
proximal position where the distal end 14 of the needle 16 is
exposed to a distal position where the shield 12 covers the distal
end 14 of the needle 16. The spring 200 is held in a biased and
compressed state by means of a retainer 202, which is movable to
release the spring 200 from a compressed state (shown in FIG. 17)
to an extended state (shown in FIG. 18). It is envisioned that
alternative methods may be employed to advance the shield. These
methods include, but are not limited to, push rods, push or pull
cables, push tapes (e.g., similar to the common tape measurer),
etc.
[0078] It is envisioned that the outer rotating housing may be
comprised of a multiple of sections of various configurations, or
may be monolithically formed, as is appropriate to the particular
application.
[0079] The various shields disclosed above may be used to measure a
desired insertion depth by positioning the shield along the needle
at a desired insertion depth. It is also contemplated that the
various shields disclosed above may be used to stabilize the needle
by grasping the shield during insertion.
[0080] The invention of the present disclosure may be embodied in
other specific forms without departing from the spirit or essential
characteristics thereof. The present embodiments are therefore to
be considered in all respects as illustrative and not restrictive,
the scope of the invention being indicated by the appended claims
rather than by the foregoing description, and all changes which
come within the meaning and range of equivalency of the claims are
therefore intended to be embraced therein.
* * * * *