U.S. patent application number 10/427389 was filed with the patent office on 2003-11-27 for parenteral fluid transfer apparatus.
Invention is credited to Biancardi, Gregory F., Holdaway, Richard G., Kearns, Richard S., Polidoro, John M., Sahi, Carl R., Seifert, John M., Seifert, Kevin J., Smutney, Chad C..
Application Number | 20030220619 10/427389 |
Document ID | / |
Family ID | 21919855 |
Filed Date | 2003-11-27 |
United States Patent
Application |
20030220619 |
Kind Code |
A1 |
Polidoro, John M. ; et
al. |
November 27, 2003 |
Parenteral fluid transfer apparatus
Abstract
A novel self-blunting needle apparatus (10d) employs a blunting
member (70) and a needle (12). The blunting member (70) may be
disposed within the needle (12) and may be adapted for fluid flow
therethrough. The needle (12) may then be inserted into a patient's
tissue and the blunting member (70) may be extended to blunt the
apparatus. In other embodiments, e.g., apparatus (10), a driver
(76) may be employed to move the blunting member (70) without
obstructing fluid flow. There may be a locking spline (58) and cam
channel (30) configuration to prevent backward motion of the
blunting member (70) in various embodiments. A hollow body (22) is
configured to facilitate assembly.
Inventors: |
Polidoro, John M.;
(Coventry, CT) ; Holdaway, Richard G.; (Storrs,
CT) ; Smutney, Chad C.; (Stafford Springs, CT)
; Sahi, Carl R.; (Coventry, CT) ; Kearns, Richard
S.; (Seattle, WA) ; Seifert, Kevin J.;
(Kinnelon, NJ) ; Biancardi, Gregory F.; (South
Windsor, CT) ; Seifert, John M.; (Trumbull,
CT) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
21919855 |
Appl. No.: |
10/427389 |
Filed: |
April 30, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10427389 |
Apr 30, 2003 |
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09404096 |
Sep 23, 1999 |
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6629956 |
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09404096 |
Sep 23, 1999 |
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PCT/US98/03813 |
Mar 23, 1998 |
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60042064 |
Mar 26, 1997 |
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Current U.S.
Class: |
604/263 |
Current CPC
Class: |
A61M 5/3257 20130101;
A61M 25/0637 20130101; A61M 5/3271 20130101; A61M 2005/3212
20130101; A61M 5/3272 20130101; A61M 25/0643 20130101 |
Class at
Publication: |
604/263 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A needle apparatus having a fluid flow passageway therethrough,
the apparatus comprising: a body member having a longitudinal axis,
a distal end and a proximal end, and a longitudinal body passageway
extending therethrough and connecting the distal end and the
proximal end of the body member in fluid flow communication with
each other; a needle component having a needle component passageway
therethrough and comprising a hub portion and a needle cannula, the
needle cannula having a longitudinal axis and being joined to, and
extending from, the hub portion and having a proximal end and a
puncture tip; a blunting component comprising a blunting member and
a blunting member hub, the blunting member having a proximal end
and a blunt distal end and being joined to, and extending from, the
needle cannula and blunting member being disposed telescopically,
one within the other; the blunting component and the needle
component being movable relative to each other from an insertion
configuration, in which the puncture tip of the needle cannula
extends beyond the blunt end of the blunting member, to a blunted
configuration, in which the blunt distal end of the blunting member
protrudes beyond the puncture tip of the needle cannula, thus
blunting the needle cannula; an air- and liquid-tight sealant
sheath disposed over the body member; and an oblique motion
deployment means for moving the apparatus from the insertion
configuration to the blunted configuration.
2. The needle apparatus of claim 1, wherein the blunting member is
dimensioned and configured to be received in the needle component
passageway.
3. The apparatus of claim 1 wherein the oblique motion deployment
means comprises a screw thread engagement between the blunting
component and the needle component.
4. The apparatus of claim 1 wherein the oblique motion deployment
means comprises a compressible pliant portion of the needle
component and the blunting component dimensioned and configured to
move from the insertion configuration to the blunted configuration
upon compression of the pliant portion of the needle component.
5. The apparatus of claim 4 comprising a fluid flow passageway
therethrough, wherein the pliant portion comprises a working fluid
reservoir, configured to isolate a working fluid therein from the
fluid flow passageway, and wherein the oblique motion deployment
means comprises a piston and cylinder engagement of the blunting
component and the needle component.
6. The apparatus of claim 1, wherein the oblique motion deployment
means comprises a drive member in articulated connection with at
least one of the blunting component and the needle component.
7. The apparatus of claim 1 wherein the oblique motion deployment
means comprises a diverted tension line.
8. A needle apparatus of claim 1, wherein the oblique motion
deployment means comprises a drive member that rotatably engages
the needle component.
9. The apparatus of claim 8 wherein the drive member is rotatable
about an axis that is aligned with the longitudinal axis of the
needle cannula.
10. The apparatus of claim 9 wherein the blunting component
comprises a shuttle portion and wherein the drive member comprises
a cam surface that bears upon the shuttle portion, the apparatus
being configured to permit the shuttle portion to serve as a cam
follower to move the apparatus from the insertion configuration to
the blunting configuration in response to rotation of the drive
member relative to the needle component.
11. The apparatus of claim 8 wherein the drive member is rotatable
about an axis that is disposed transversely to the longitudinal
axis of the needle cannula.
12. A needle apparatus comprising: a needle component having a
needle component passageway therethrough and comprising a hub
portion and a needle cannula, the needle cannula having a
longitudinal axis and being joined to, and extending from, the hub
portion and having a proximal end and a puncture tip; a blunting
component comprising a blunting member and a blunting member hub,
the blunting member having a proximal end and a blunt distal end,
the blunting member being joined to, and extending from, the
blunting member being dimensioned and configured to be received in
the needle component passageway; the blunting component and the
needle component being movable relative to each other from an
insertion configuration, in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, to a
blunted configuration, in which the blunt distal end of the
blunting member protrudes beyond the puncture tip of the needle
cannula, thus blunting the needle cannula; and a contrary motion
mechanism for moving the blunting member forward relative to the
needle cannula in response to a rearward motion imposed by the
user.
13. The apparatus of claim 12 wherein the contrary motion mechanism
comprises a tension line.
14. The apparatus of claim 12 wherein the contrary motion mechanism
comprises a roller.
15. The apparatus of anyone of claim 12 further comprising a
locking means for locking the apparatus in the blunted
configuration.
16. The apparatus of claim 15, wherein the locking means comprises
a spline and cam channel engagement between the blunting component
and the needle component.
17. The apparatus of claim 15, wherein the locking means comprises
(i) a detent on one of the needle component and the blunting
component, and (ii) a ramp on the other, the ramp defining a
shoulder, and wherein the detent is positioned and configured to
ride up the ramp as the blunting member is advanced to be
positioned to bear against the shoulder to inhibit rearward
movement after the blunted configuration is attained.
18. The apparatus of claim 17 further comprising a return ramp for
permitting the detent to move axially past the shoulder so that the
apparatus can return to the insertion configuration.
19. The apparatus of claim 15, wherein the locking means comprises
a detent and an axially-extending slot arrangement wherein the
detent is positioned and configured to move axially in the slot as
the blunting member is advanced, and wherein the slot is configured
to define a pinch region through which the detent passes, the pinch
region being configured to inhibit entry of the detent into the
slot once the blunted configuration is attained.
20. The apparatus of claim 19 further comprising a return ramp for
permitting the detent to move axially past the shoulder so that the
apparatus can return to the insertion configuration.
21. A needle apparatus comprising: a needle component having a
needle component passageway therethrough and comprising a hub
portion and a needle cannula, the needle cannula having a
longitudinal axis and being joined to, and extending from, the hub
portion and having a proximal end and a puncture tip; a blunting
component comprising a blunting member and a blunting member hub,
the blunting member having a proximal end and a blunt distal end,
the blunting member being joined to, and extending from, the
blunting member being dimensioned and configured to be received in
the needle component passageway; the blunting component and the
needle component being movable relative to each other from an
insertion configuration, in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, to a
blunted configuration, in which the blunt distal end of the
blunting member protrudes beyond the puncture tip of the needle
cannula, thus blunting the needle cannula; and a stored energy
device and release mechanism for moving the blunting member forward
relative to the needle cannula.
22. The needle apparatus of claim 15, wherein the stored energy
device and release mechanism comprises a spring and detent
mechanism.
23. A needle apparatus having a fluid flow passageway therethrough
extending from a first aperture to a second aperture, the apparatus
comprising: a needle component comprising a needle cannula
terminating in a puncture tip that comprises the first aperture of
the apparatus, and at its end opposite the puncture tip being
mounted on a needle hub, and a blunting member terminating in a
blunt end and at its end opposite the blunt end being mounted on a
blunting member hub, the needle component and the blunting member
component being configured to be received one within the other to
provide an outer component and an inner, movable component, the
blunting component and the needle component being movable between
an insertion configuration in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, to a
blunted configuration in which the blunt tip extends beyond the
needle tip to thus blunt the needle cannula, wherein the outer
component defines a second aperture of the apparatus and an access
aperture and the inner component comprises a lug that protrudes
through the access aperture for manipulation to move the apparatus
from the insertion configuration to the blunted configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is continuation of U.S. application Ser.
No. 09/404,096, filed Sep. 23, 1999, which is a
continuation-in-part and claims priority to co-pending
International Application PCT/US98/03813, filed Mar. 23, 1998, now
abandoned, which designated the United States, and which claims the
benefit of U.S. provisional application No. 60/042,064, filed Mar.
26, 1997, the entireties of which are incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to parenteral fluid transfer
apparatus having a body member through which fluids are
parenterally delivered to and/or withdrawn from a patient (human or
animal) through venipuncture or the like. More particularly, this
invention is directed to such apparatus having a needle and a
self-blunting mechanism.
[0004] 2. Description of the Related Art
[0005] For reasons which have received wide publicity, there is
substantial demand for self-blunting venipuncture products which
may be employed by healthcare workers with minimal risk of
incurring accidental needle-stick wounds. A highly successful
venipuncture product of this nature is sold under the trademark
PUNCTUR-GUARD.RTM. by Bio-Plexus, Inc. of Vernon, Conn. The
PUNCTUR-GUARD blood collection needle assembly is manufactured in
accordance with the teachings of U.S. Pat. No. 4,828,547, issued on
May 9, 1989 to Carl R. Sahi et al, the disclosure of which is
hereby incorporated herein by reference. In the PUNCTUR-GUARD.RTM.
product, a tubular blunting member is disposed within the bore of a
needle, i.e., a needle cannula having a conventional beveled tip
suitable for penetrating tissue to initiate venipuncture. The
blunting member and needle combination of the syringe is initially
in an insertion configuration, in which the tissue puncture tip of
the needle extends beyond the blunt tip of the blunting member, so
normal penetration of the needle into tissue is not affected. The
user takes a conventional finger and thumb grip on the barrel
finger rest and plunger thumb rest to manipulate the needle. After
venipuncture has been achieved, but prior to removal of the needle
from the patient, the user advances the syringe plunger relative to
the needle by applying thumb and finger pressure to the thumb and
finger rests, thus advancing the blunting member so that the tip of
the blunting member extends beyond the tissue-penetrating tip of
the needle. In this extended configuration of the blunting member
and needle combination, the needle tip is effectively blunted to
thereby prevent accidental needle-stick wounds upon or after
removal of the needle from the patient. Such an arrangement offers
the advantages of being economical, reliable and simple in
construction and in use.
[0006] Another known, commercially available device that makes use
of a self-blunting needle assembly is a blood collection needle.
The needle assembly comprises a needle cannula mounted in a hub.
The hub is configured to engage a standard blood collection tube
holder. The assembly comprises a blunting component that comprises
a hub having a tubular member extending therethrough. One portion
of the tubular member (referred to as the blunting member) extends
from the blunting component hub, terminates with a blunt end, and
is configured to be slidably received within the needle cannula.
The other end of the tubular member extends from the blunting
component hub in the opposite direction and terminates with a
puncture tip for puncturing the seal on a conventional blood
collection vial. The blunting component hub slidably engages the
needle component hub and is movable from a retracted position in
which the blunt end of the tubular member is within the needle
cannula, placing the assembly in a sharpened, insertion
configuration, to an extended position in which the blunt end of
the tubular member extends beyond the tip of the needle cannula,
thus blunting the needle and placing the assembly in a blunted
configuration. A groove and detent arrangement between the needle
hub and the blunting component hub secures the assembly in the
blunted configuration. The assembly is secured in the holder in the
insertion configuration. The user grasps the collection tube holder
to insert the needle cannula into a patient's vein. Then, a blood
collection tube is inserted into the holder and the puncture tip of
the tubular member penetrates the seal on the vial, permitting
blood to flow into the tube. To blunt the needle, the user pushes
the collection vial further into the holder, causing the seal to
bear upon the blunting component hub and to advance the blunting
component into the extended position to blunt the needle
assembly.
[0007] The art shows attempts to reduce the accidental needle-stick
danger associated with the use of other medical sharps as well,
often by the use of exterior sheathing devices such as that of
McCormick et al, U.S. Pat. No. 5,176,655. Other medical sharps
devices employing needle-sheathing devices are illustrated by
Dombrowski et al U.S. Pat. No. 4,790,828; Dombrowski et al U.S .
Pat. No. 4,978,344; Vaillancourt U.S. Pat. No. 4,804,371; and
Karczmer U.S. Pat. No. 4,795,432.
[0008] U.S. Pat. No. 4,627,841 to Dorr, issued on Dec. 9, 1986,
discloses an infusion needle having a needle mounted in a hub and a
hollow blunting member mounted in a hub and being telescopically
received within the needle. A spring pulls the hubs together,
causing the forward end of the blunting member to extend beyond the
needle tip. The rearward end of the blunting member is secured to a
tube or other fluid flow device. The device comprises wings that
carry wedges and that are folded towards each other to provide a
haft by which the user manipulates the needle. When the wings are
folded towards each other, the wedges are driven between the needle
hub and the blunting member hub, thereby separating the hubs by
overcoming resistance of the spring and causing the blunting member
to retract into the needle.
SUMMARY OF THE INVENTION
[0009] Generally, the present invention overcomes the
above-discussed and other deficiencies and disadvantages of the
prior art by providing novel and improved parenteral fluid flow
apparatuses for subcutaneous delivery of fluids to, and/or
withdrawal of fluids from, a patient.
[0010] One broad aspect of the present invention provides a needle
apparatus comprising a cannula component comprising a needle
cannula and a blunting member. The needle cannula has a
longitudinal axis, a puncture tip, and a needle passageway
therethrough, and the blunting member has a blunt end. The needle
cannula and the blunting member are disposed telescopically one
within the other and are configured for movement (i) from an
insertion configuration in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, (ii)
to a blunted configuration in which the blunt end of the blunting
member extends beyond the puncture tip to blunt the apparatus.
There is a haft connected to the cannula for use in manipulating
the cannula component, and an oblique motion deployment means for
moving the apparatus from the insertion configuration to the
blunted configuration independently of the function of the haft
means.
[0011] A needle apparatus in accordance with the present invention
may have a fluid flow passageway therethrough and may comprise a
needle component having a needle component passageway therethrough
and comprising a hub portion and a needle cannula, the needle
cannula having a longitudinal axis and being joined to, and
extending from, the hub portion and having a proximal end and a
puncture tip. There is also a blunting component comprising a
blunting member having a proximal end and a blunt distal end, the
blunting component being dimensioned and configured to be received
in the needle component passageway. The blunting component and the
needle component are movable relative to each other from an
insertion configuration, in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, to a
blunted configuration, in which the blunt distal end of the
blunting member protrudes beyond the puncture tip of the needle
cannula, thus blunting the needle cannula. There is an oblique
motion deployment means for moving the apparatus from the insertion
configuration to the blunted configuration, and a haft connected to
the needle component for use in manipulation of the needle cannula
without moving the apparatus from the insertion configuration to
the blunted configuration.
[0012] According to one aspect of the invention, the oblique motion
deployment means may comprise a screw thread engagement between the
blunting component and the needle component. Alternatively, the
oblique motion deployment means may comprise a pliant portion of
the needle component configured to be compressible by the user. The
blunting component may be dimensioned and configured to move from
the insertion configuration to the blunted configuration upon
compression of the pliant portion of the needle component.
Optionally, the apparatus may comprise a fluid flow passageway
therethrough and the pliant portion may comprise a working fluid
reservoir, the working fluid being isolated from the fluid flow
passageway, and wherein the deployment means comprises a piston and
cylinder engagement of the blunting component and the needle
component.
[0013] According to another aspect of the invention, an apparatus
may comprise deployment means comprising a drive member in
articulated connection with at least one, optionally both, of the
blunting component and the needle component. For example, the drive
member may rotatably engage the needle component. Optionally, the
drive member is rotatable about an axis that is aligned with the
longitudinal axis of the needle cannula. In one embodiment, the
blunting component may comprise a shuttle portion and the drive
member may comprise a cam surface that bears upon the shuttle
portion. The apparatus may be configured to permit the shuttle
portion to serve as a cam follower to move the apparatus from the
insertion configuration to the blunting configuration in response
to rotation of the drive member relative to the needle component.
Alternatively, the drive member may be rotatable about an axis that
is disposed transversely to the longitudinal axis of the needle
cannula.
[0014] In another embodiment, the drive member may comprise a
contrary motion linkage between the blunting component and the
needle component such as a lever or a diverted tension line.
[0015] In a particular embodiment, the deployment means may
comprise a stored energy means and a release mechanism.
[0016] According to another aspect of this invention, the apparatus
may comprise locking means for locking the apparatus in the blunted
configuration. The locking means may comprise a spline and cam
channel engagement between the blunting component and the needle
component.
[0017] In some embodiments, the apparatus comprises a blunting
component and the needle component disposed in a tandem
configuration wherein the blunting component defines the proximal
aperture of the apparatus. In other embodiments, the drive member
is disposed in tandem relation to the needle component and defines
the proximal aperture of the apparatus. In still other embodiments,
the needle component defines the proximal aperture of the
apparatus.
[0018] In one particular embodiment, the apparatus may comprise a
pair of wings that are connected to the needle component. The wings
may be displaceable about a displacement axis that is aligned with
the longitudinal axis of the needle cannula and may be movable
between a manipulation position and a neutral position. There may
be a tension line secured to the wings and connected to the
blunting component, the tension line being configured so movement
of the wings from the manipulation position to the neutral position
causes the tension line to move the apparatus from the insertion
configuration to the blunted configuration.
[0019] Another broad aspect of this invention provides a needle
apparatus comprising a needle component comprising a hub portion
and a needle cannula, the needle cannula being joined to, and
extending from, the hub portion and having a proximal end and a
puncture tip, and defining a longitudinal axis, the hub portion and
the needle cannula cooperating to define a needle component
passageway for fluid flow therethrough. There is a blunting
component comprising a blunting member having a blunt distal end
and a proximal end, the blunting member being disposed in coaxial
relation to the needle cannula. The blunting component and the
needle component are movable relative to each other from an
insertion configuration, in which the puncture tip of the needle
cannula extends beyond the blunt end of the blunting member, to a
blunted configuration, in which the blunt distal end of the
blunting member protrudes beyond the puncture tip of the needle
cannula, thus blunting the needle cannula. The apparatus includes
locking means comprising a spline and a cam channel, for locking
the apparatus in the blunted configuration.
[0020] In one embodiment, the cam channel may comprise a catch
portion, the apparatus comprising catching means for moving the
spline into the catch portion of the channel. The catching means
may comprise a slide surface in the cam channel. Optionally, the
blunting component may comprise a driving means for engaging the
needle component and the blunting member and for moving the
apparatus from the insertion configuration to the blunted
configuration.
[0021] Still another broad aspect of this invention provides a
needle apparatus having a fluid flow passageway therethrough
extending from a first aperture to a second aperture comprising a
needle component comprising a needle cannula mounted on a needle
hub and a blunting member mounted on a blunting member hub. The
needle cannula comprises a puncture tip that defines the first
aperture of the apparatus. The needle component and the blunting
member component are configured to be received one within the other
to provide an outer component and an inner, movable component. The
blunting component and the needle component are movable between an
insertion configuration in which the tip of the needle extends
beyond the blunt end of the blunting member to a blunted
configuration in which the blunt tip extends beyond the needle tip
to obscure the needle tip and thus blunt the apparatus. The outer
component defines the second aperture of the apparatus and further
comprises an access aperture. The inner component comprises a lug
that protrudes through the access aperture for manipulation by the
user to permit the user to move the apparatus from the insertion
configuration to the blunted configuration.
[0022] Another aspect of this invention relates to a needle
apparatus comprising (a) a body member having a longitudinal axis,
a proximal end and a distal end, and a longitudinal body passageway
extending therethrough and connecting the proximal end and the
distal end of the body member in fluid flow communication with each
other; (b) a cannula component carried on the body member and
disposed therein in fluid flow communication with the body
passageway, the cannula component comprising a needle member and a
blunting member, the needle member having a tissue puncture tip and
a needle proximal end, and the blunting member having a blunting
tip and a blunting member proximal end, the needle member and the
blunting member being arranged with their respective tips facing in
the same direction, and telescopically one within the other for
relative axial movement of the needle member and the blunting
member from (i) an insertion configuration of the cannula
component, in which the puncture tip extends beyond the blunting
tip, to (ii) a blunted configuration of the cannula component, in
which the blunting tip extends beyond the tissue puncture tip to
blunt the same; (c) a shuttle member mounted for axial movement
within the body passageway, the shuttle member (1) being
dimensioned and configured to provide a first fluid flow passageway
extending therethrough, and (2) engaging one of the blunting member
and the needle member whereby axial movement of the shuttle member
causes axial movement of the blunting member and needle member
relative to each other to change the cannula component from its
insertion configuration to its blunted configuration; and (d) a
drive member in the body passageway which (1) is manipulable from
exteriorly of the body member, (2) is dimensioned and configured to
leave the body passageway open to fluid flow between the proximal
and distal ends of the body member, and (3) is operatively
connected to the shuttle member, whereby manipulation of the drive
member moves the shuttle member axially through the body
passageway, thereby changing the cannula component from its
insertion configuration to its blunted configuration, without
significant hydraulic effect on biologic fluid in the
apparatus.
[0023] The drive member may comprise a cam surface and the shuttle
may comprise a following surface. The apparatus may further
comprise an actuator connected to the drive member and accessible
for manipulation thereof from exteriorly of the body member, the
drive member (1) being mounted for rotation within the body
passageway, (2) being rotatable therein by manipulation of the
actuator, and (3) operatively engaging the shuttle member, wherein
manipulation of the actuator rotates the drive member to impose
force on the following surface via the cam surface to move the
shuttle member axially along the body passageway, thereby changing
the cannula component from its insertion configuration to its
blunted configuration. In a particular embodiment, the needle
member may be mounted on the body member and the blunting member
may be mounted on the shuttle member and may be disposed
telescopically within the needle member.
[0024] There may be locking means comprising a spline member and
cam channel engagement of the blunting component and the needle
component, the cam channel comprising an axially extending guide
channel and a catch portion that connects with the guide channel at
a lateral channel entryway, and the catch portion extending
transversely of the guide channel and comprising a backward stop
surface;
[0025] wherein the spline member is dimensioned and configured to
traverse the guide channel as the blunting component moves from the
insertion configuration to the blunted configuration; and
[0026] wherein the following surface of the shuttle member and the
cam surface of the drive member are each dimensioned and configured
so that rotation of the drive member in one direction advances the
spline member along the guide channel and into the catch portion
for engagement therewith, and rotation of the drive member in the
opposite direction effectively disengages the cam follower and the
cam surface, thereby locking the apparatus in the blunted
configuration.
[0027] There may be an air- and liquid-tight sealant sheath
disposed over the body member. Yet another aspect of the invention
relates to a needle apparatus comprising a hollow body, the body
having a proximal end and a distal end and defining a cavity
extending along a body axis from the proximal end to the distal end
of the body. The cavity includes a first generally conical region
disposed at the distal end of the body, a first generally
cylindrical region coaxially disposed adjacent the first conical
region, a second generally cylindrical region coaxially disposed
adjacent the first cylindrical region, a second generally conical
region coaxially disposed adjacent the second cylindrical region
and a third generally cylindrical region coaxially disposed
adjacent the second conical region and extending therefrom to the
proximal end of the body, the diameter of the second cylindrical
region being less than that of the first cylindrical region and the
diameter of the third cylindrical region being greater than that of
the second cylindrical region. There is a cannula having a forward
end and a terminal end, the outer diameter of the cannula being
substantially equal to the diameter of the first cylindrical region
of the cavity, the terminal end of the cannula being received
within the first cylindrical region such that the forward end
extends forwardly of the distal end of the body and the cannula
extends along the body axis. There is also a movable member means
being at least partially disposed within the body cavity and having
a forward end and an outer diameter which is not greater than
either of the inner diameter of the cannula or the diameter of the
second cylindrical region of the cavity, the movable member
extending through the second cylindrical region of the cavity and
being at least partially movably received within the cannula. One
of the forward end of the cannula the forward end of the movable
member having a tissue puncture tip and the other of the forward
end of the cannula or the forward end of the movable member having
a blunt tip.
[0028] The locking means of the foregoing devices may optionally
comprise a detent on one of the needle component and the blunting
component, and a ramp on the other. The ramp may define a shoulder,
and the detent is positioned and configured to ride up the ramp as
the blunting member is advanced to be positioned to bear against
the shoulder to inhibit rearward movement after the blunted
configuration is attained.
[0029] Independently, the locking means may comprise a detent and
an axially extending slot arrangement wherein the detent is
positioned and configured to move axially in the slot as the
blunting member is advanced. The slot may be configured to define a
pinch region through which the detent passes, the pinch region
being configured to inhibit entry of the detent into the slot once
the blunted configuration is attained.
[0030] In either case, there may optionally be a return ramp for
permitting the detent to move axially past the shoulder so that the
apparatus can return to the sharpened configuration.
[0031] Any of the foregoing embodiments may comprise locking means,
optionally comprising a spline and cam channel, for locking the
apparatus in the blunted configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] The present invention will be described below with reference
to the accompanying drawings, wherein:
[0033] FIG. 1 is a perspective view of a winged set comprising a
parenteral flow transfer apparatus in accordance with one
embodiment of the present invention in combination with associated
components comprising a protective casing, a fluid transfer tube
and a female luer adapter;
[0034] FIG. 2 is an exploded, side elevation view of the components
of the apparatus of FIG. 1, excluding the associated components
shown in FIG. 1;
[0035] FIG. 3 is a top plan view, partly in cross section, of the
apparatus and associated components depicted in FIG. 1;
[0036] FIG. 4A is a side elevation view of the body member of the
apparatus depicted in FIG. 2;
[0037] FIG. 4B is a perspective view of the body member of the
apparatus depicted in FIG. 2;
[0038] FIG. 5 depicts the driver, shuttle member and body member of
FIG. 2 in axial alignment with one another;
[0039] FIG. 6A is a top plan view of the body member and winged
sheath of the apparatus shown in FIGS. 1 and 3;
[0040] FIG. 6B is a cross-sectional elevation side view of the body
member and winged sheath shown in FIG. 6A;
[0041] FIG. 6C is a side elevation view of the winged sheath and
driver of the needle apparatus of FIG. 1 in combination with an
alternative locking means;
[0042] FIG. 6D is a partly cross-sectional view of a syringe
comprising the locking spline and cam channel engagement of a
blunting component and a needle component in accordance with one
aspect of the present invention;
[0043] FIG. 7A is a partially exploded, perspective view of another
embodiment of an apparatus in accordance with the present
invention;
[0044] FIG. 7B is an exploded view of a blood collection needle in
accordance with various aspects of the present invention;
[0045] FIGS. 7C and 7D are elevational views of the self-blunting
needle assembly used in the blood collection needle of FIG. 7B
shown in the blunted and sharpened configurations,
respectively;
[0046] FIG. 7E is an elevation view of the driver of the blood
collection needle of FIG. 7B;
[0047] FIGS. 7F and 7G are schematic illustrations of the assembled
blood collection needle of FIG. 7B in the sharpened and blunted
configurations, respectively;
[0048] FIG. 7H is a cross-sectional view of a particular embodiment
of a blood collection needle as generally represented by FIGS.
7B-7G;
[0049] FIGS. 8 and 8B are plan views, and FIG. 8A is an enlarged
partial plan view of a blunting apparatus comprising a tension line
for deploying the blunting member and a lug and access slot locking
means;
[0050] FIG. 9 is a plan view of a needle apparatus in which the
internal blunting member has a lug that protrudes through an access
slot in the needle member;
[0051] FIG. 9A is a plan view of a rotatable lug for use in a catch
slot locking means;
[0052] FIG. 10 is a partially cross-sectional plan view of a needle
apparatus having a pliant external member for moving the internal
member;
[0053] FIG. 11 is a partially cross-sectional plan view of a needle
apparatus having a piston deployment means for moving the blunting
member;
[0054] FIG. 12A is a plan view of a screw thread embodiment of a
needle apparatus;
[0055] FIG. 12B is an exploded perspective view of a needle
apparatus having a rotatable drive member and a detent and catch
slot locking means;
[0056] FIG. 12C is a different perspective view of the drive member
of FIG. 12B;
[0057] FIG. 12D is a schematic plan view of an alternative
embodiment of the apparatus illustrated in FIGS. 12B and 12C;
[0058] FIG. 12E is a perspective view of the winged body of a
needle apparatus having ramp and detent locking means, a pinch
region locking means and a reset ramp;
[0059] FIG. 12F is a view similar to FIG. 12E of an alternative
ramp locking means;
[0060] FIGS. 13A, 13B and 13C are elevation views of needle
apparatuses comprising various reverse motion mechanisms; and
[0061] FIGS. 14A and 14B are plan and partially cross-sectional
elevation views of a needle apparatus comprising a spring and
release deployment mechanism.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0062] The present invention provides parenteral fluid transfer
apparatuses (or "needle apparatuses") for medicinal use which can
be blunted during use and which preferably (but not necessarily)
permit fluid flow therethrough even while blunted. Typically, the
fluid flowing through the apparatus is either a medicinal fluid
being administered to a patient or a metabolic fluid (e.g., blood)
being withdrawn from the patient. Such fluids are referred to
collectively herein as "biologic fluids". As will be discussed
below, the term "needle apparatus", as used herein, encompasses
various needle devices such as, for example, wing sets, blood
collection needles, syringes and catheters.
[0063] A needle apparatus in accordance with one principal aspect
of this invention comprises a cannula component comprising a needle
cannula and a blunting member disposed telescopically one within
the other. The longitudinal axis of the needle cannula defines the
axis of the apparatus. Typically, the blunting member and the
needle cannula each carry a hub in which they are mounted, and
together with which they comprise a blunting component or needle
component, respectively. Since the blunting member and the needle
cannula are disposed telescopically one within the other, one of
the blunting component and the needle component constitutes an
inner component and the other constitutes an outer component. The
member comprising part of the inner component (most often
illustrated herein as the blunting member) is sometimes referred to
herein as the moving member. Whatever their relative
configurations, the needle cannula has a sharp puncture tip at its
distal or forward end (i.e., the end directed towards the patient
by another (referred to herein as the "user") when the needle is
inserted) and the blunting member has a blunt tip at its forward
end. The needle cannula and the blunting member are movable
relative to each other from an insertion or sharpened
configuration, in which the sharp tip of the needle cannula extends
beyond the blunt end of the blunting member, to a blunted
configuration, in which the forward blunt end of the blunting
member extends beyond the sharp tip of the needle cannula and thus
blunts the needle cannula of the apparatus. In particular
embodiments of this invention, the cannula component can be blunted
and still permit the flow of fluid therethrough. Such embodiments
may be described as comprising a nonobstructive blunting member,
i.e., a blunting member that is either disposed outside the needle
cannula or one that is disposed inside the needle cannula (an
"internal" blunting member) but that permits fluid flow
therethrough nonetheless. A non-obstructive internal blunting
member may allow fluid to flow around it within the needle cannula,
through it, or both. An obstructive blunting member obturates the
needle cannula and substantially stops fluid flow therethrough.
[0064] Some apparatuses according to the present invention comprise
an oblique motion deployment means for changing the configuration
of the apparatus at least from an initial insertion configuration
to a blunted configuration. The oblique motion deployment means
permits the user to effect relative axial movement between the
blunting component and the needle component without applying a
direct axial force to one or the other. Rather, the oblique motion
deployment means allows the user to effect such relative axial
movement by applying an oblique motion, optionally by manipulating
an intermediate structure (referred to herein as a drive member)
joined to both the blunting component and the needle component. In
various embodiments, the oblique motion may be achieved by applying
radial, lateral or rotational force rather than a substantially
directly forward or rearward axial force to the appropriate
structure of the apparatus. By allowing the user to avoid applying
direct axial force on the apparatus, the oblique motion deployment
means reduces the risk that the user might inadvertently impose a
jarring motion on the needle that would drive the needle deeper
into the injection site than is necessary or desired.
[0065] Certain aspects of this invention are disclosed herein as
pertaining to flow-through devices such as winged needle
apparatuses which are designed to permit attachment to generic
fluid handling devices such as tubing or a luer connector. Some
such aspects of the invention might therefore not pertain to more
specialized devices such as syringes or blood collection needles,
in which the connectivity issues are more limited.
[0066] In various embodiments, e.g., some winged needle apparatuses
and blood collection needles, the deployment means may operate
without significantly affecting the flow of fluid through the
apparatus, i.e., without significant hydraulic effect on biologic
fluid in the flow passageway of the apparatus. Thus, the blunting
component may be deployed without requiring or causing biologic
fluid to flow through the apparatus, or without interfering with
such flow. The mere effect, if any, of friction between the
biologic fluid and a moving non-obstructive blunting member in
contact therewith is not a significant hydraulic effect for
purposes of this invention.
[0067] An apparatus in accordance with the present invention
typically comprises a haft to facilitate handling of the needle
cannula by the user for the purpose of effecting venipuncture. The
haft can take a variety of forms, such as the wings of a winged
needle apparatus, the thumb and finger rests on a hypodermic
syringe, or even the sides of a body in which the needle is
mounted. The haft of a winged needle apparatus typically comprises
a pair of resilient wings that normally lie in a common plane, but
which are bendable, i.e., displaceable. The user may bend the wings
out of their common plane and pinch them together between the thumb
and forefinger in a manipulation position, thus providing a
convenient means for handling the cannula component and for
inserting the needle where required.
[0068] In certain embodiments of the present invention, the
displacement of the haft, e.g., the bending of the wings, will not
force the deployment means to change the device between its blunted
and insertion configurations. In other words, the oblique motion
deployment means of the present invention may be operable
independently of the user's employment of the haft, i.e.,
independently of the user's grasp on the device to manipulate and
insert the needle. Such embodiments may be described as comprising
non-deploying haft, to identify the distinction over, e.g., the
Dorr Patent, U.S. Pat. No. 4,627,841, discussed above. In other
embodiments, displacement of the wings (or other haft means) may
change the configuration of the apparatus.
[0069] In some embodiments of this invention, the needle component
will encompass the entire flow passageway of the apparatus,
providing a forward or distal aperture at the tip of the needle at
one end and a rearward or proximal aperture at the opposite end,
with the fluid flow passageway of the apparatus extending
therebetween. In other embodiments, two or more components may each
define a flow aperture and may be disposed in tandem to each other
so that the fluid flow passageway of the apparatus extends from one
component to the next. For example, the blunting component may
comprise a hollow blunting member within the needle cannula and may
sealingly engage the interior of the needle component. The blunting
component, however, may protrude from the proximal end of the
needle component passageway and may define the proximal aperture of
the device (to which, e.g., a luer adapter may be connected) and
the fluid flow passageway may extend from the proximal aperture to
the needle tip. In other embodiments, a drive member may define the
proximal aperture and may sealingly engage the needle component or
the blunting component in tandem configuration therewith.
[0070] Various embodiments of this invention may comprise a drive
member that is rotatable relative to one or both of the needle
cannula and the blunting member. The drive member may be rotatable
about an axis that is aligned with (i.e., substantially parallel
with) the longitudinal axis of the needle cannula or along an axis
that is disposed transversely, preferably substantially
perpendicular, to it. In various other embodiments, the drive
member may comprise a lever, a tension line, a stored energy
mechanism or a contrary motion mechanism.
[0071] As mentioned above, in the preferred embodiments of this
invention, the blunting member is deployed from within the needle,
so the device can be blunted after insertion into tissue but before
the needle is withdrawn, i.e., while the needle is in the patient
and fluid is flowing therethrough, without any need to withdraw the
needle or to disrupt the tissue surrounding the needle, as would be
required with the prior art device as shown in U.S. Pat. No.
5,176,655. By blunting the needle while it is in the patient, risk
to the user is reduced by obviating the need to expose the puncture
tip upon removal of the needle, and the patient is protected
against post-insertion injury that maybe caused by inadvertent
jostling of the needle. Thus, winged needle apparatuses in
accordance with the present invention may be safely employed in
many situations where standard intravenous catheters (which are
blunt) were previously preferred.
[0072] The various embodiments of the invention can include any
suitable locking means to inhibit the inadvertent retraction of the
blunting member from the blunted configuration to the insertion
configuration. However, the present invention also provides novel
locking means that can be employed with a variety of needle
apparatuses. One embodiment of the novel locking means comprises a
spline and cam channel engagement between the needle component and
the blunting component of the device. As will be described below,
the spline and cam channel engagement permits the blunting
component to move from an insertion configuration, in which the
blunting component is withdrawn, to a blunted configuration, in
which the blunting component extends beyond the tip of the needle
and thus blunts the device. However, the spline and cam channel
engagement inhibits the blunting component against a return motion
that would otherwise move the blunting component towards its
retracted position to place the device back in the insertion
configuration. In addition, if the device comprises a driver for
moving the blunting component, the driver may be dimensioned and
configured to disengage from the blunting component after the
blunted configuration is achieved. Other locking mechanisms may be
employed as well, as discussed below. Still other embodiments of
this invention relate to needle apparatuses that comprise a hollow
body that facilitates the assembly of the apparatus with one
component telescopically received in another. These and other
aspects of the invention will now be described herein with
reference to the Figures.
[0073] One embodiment of a parenteral fluid transfer apparatus
("needle apparatus") according to the present invention comprises a
self-blunting winged needle apparatus 10, shown in FIG. 1, having a
needle 12, a winged body 14, and a winged driver 76. The apparatus
10 is shown as part of a winged set 100 that comprises a protective
sheath disposed around needle 12 and a connector comprising a
collection tube 72 and a conventional female luer adapter 74.
(Sheath 11 and the connector are not, per se, part of the
invention.) Sheath 11 is a conventional sheath which is provided to
prevent damage to needle 12 during shipping. Adapter 74 may be
fitted to other devices such as a syringe, a fluid reservoir or the
like. Apparatus 10 is, therefore, capable of cooperating with tube
72 and adapter 74 to provide a fluid flow passageway therethrough
to achieve fluid transfer between a patient and a hypodermic needle
or any of the many other similar well-known devices having a fluid
reservoir. Winged body 14 preferably includes a central member 15
with first and second wings 16 and 18, respectively, extending from
opposite sides of member 15. Needle 12 is mounted in and is
oriented coaxially with central member 15 such that a puncture tip
13 of needle 12, which comprises a puncture tip, is directed
forwardly of central member 15 with a beveled end thereof facing
upwardly. The wings 16, 18 are connected to needle 12 via central
member 15 and can be folded upward, together, to provide a
convenient haft by which a user can manipulate the needle 12 which,
as described below, is part of the cannula component of the
apparatus.
[0074] Referring now to FIG. 2 and FIG. 3, needle 12 has a
longitudinal axis A-A and a proximal end 12a (FIG. 2) that is
preferably fixed to a distal end 22a of a hollow body 22 with a
needle adhesive 20 (FIG. 3) such that needle 12 extends coaxially
forward of the distal end 22a of hollow body 22. Together these
structures comprise a hub portion in which needle 12 is mounted.
The hub portion and needle together comprise the needle component
of the apparatus. The cylindrical central member 15 of winged body
14, the cavity 24 in hollow body 22 and needle 12 cooperate to
define a needle component passageway therethrough, through which
biologic fluids may flow.
[0075] FIGS. 4A and 4B depict hollow body 22 in side elevation and
perspective views with the hidden details of cavity 24 shown in
phantom. As shown therein, hollow body 22 is generally in the form
of a hollow cylinder having cavity 24 extending therethrough and
defining a body axis that will coincide with longitudinal axis A-A.
At distal end 22a of hollow body 22, cavity 24 converges into a
plurality of coaxially disposed regions sized and shaped to
facilitate assembly of apparatus 10. In particular, beginning at
distal end 22a, cavity 24 is bounded by a frusto-conical needle
insertion funnel 40. Immediately adjacent funnel 40, cavity 24 is
bounded by a cylindrical region 38 with a diameter which is
substantially equal to the outer diameter of needle 12. Immediately
adjacent cylindrical region 38, cavity 24 takes the form of a
blunting member passageway defined by cylindrical region 36. Since
the diameter of cylindrical region 36 is less than that of
cylindrical region 38, the junction between cylindrical regions 36
and 38 defines a hollow circular wall therebetween. Immediately
adjacent cylindrical region 36, cavity 24 is bounded by a
frustoconical blunting member insertion funnel 34. The remainder of
cavity 24 is dimensioned and configured to permit shuttle 54 to
travel therethrough, and to receive and permit the rotation therein
of cam member 80 of driver 76. As best illustrated in FIG. 4B,
hollow body 22 comprises a pair of oppositely disposed driver lock
tabs 44 at its proximal end. Tabs 44 protrude slightly into cavity
24 and thereby provide a flexible interference fit between hollow
body 22 and shuttle 54 and driver 76 (FIG. 2) upon their insertion
into cavity 24, as will be described below.
[0076] Cavity 24 of body 22 opens radially into a cam channel 30
which is a composite of a plurality of channels that are sized and
shaped to cooperate with a spline 58 (FIG. 2) extending from
shuttle 54, as will be described below. Cam channel 30 is comprised
of an insertion channel 26, a first lateral channel 28, a guide
channel 31 and a second lateral channel 32. Insertion channel 26 is
open at the proximal end 22b of body 22 and has a linear
configuration that runs substantially parallel to axis A-A; first
lateral channel 28 extends radially about axis A-A and is bounded
by a stop surface 28a disposed in perpendicular relation to axis
A-A and a slide surface 28b which has an oblique disposition
relative to axis A-A and which extends towards distal end 22a.
Lateral channel 28 leads to guide channel 31 which, like insertion
channel 26, extends axially, in substantially parallel relation to
axis A-A. Guide channel 31 leads to second lateral channel (or
"catch portion") 32, which is bounded by forward stop surface 32a,
a rearward stop surface 32b and an axial surface 32c. Both surfaces
32a and 32b may be disposed in perpendicular relation to axis A-A,
but surface 32b is preferably disposed at a slightly oblique angle
relative to axis A-A and extends from guide channel 31 towards
axial surface 32c with a slight incline towards proximal end
22b.
[0077] FIG. 5 illustrates numerous structural details of driver 76
and shuttle 54 as well as hollow body 22. Driver 76 comprises a
generally cylindrical driver body 76a that has a driver passageway
86 extending therethrough from a proximal aperture 86b. Third wing
78 extends from driver body 76a to provide a deployment haft that
is designed to be manipulated by the user. As indicated above,
proximal aperture 86b is dimensioned and configured to couple with
a conventional fluid flow connector. The opposite end of driver
body 76a defines a cam member 80 on which cam surfaces 82 and 84
are formed. In its central region, driver body 76a defines coupling
features including rings 85, trough 87, ring 83 and retention
groove 88 intended to facilitate the coupling of driver 76 with
other structures in the apparatus, as will be described further
below.
[0078] FIG. 5 also shows shuttle 54 disposed in spaced alignment
with driver 76 along a common axis A-A. Shuttle 54 is generally
cylindrically shaped and has a blunting member reception aperture
68 (shown in phantom) extending therethrough for coaxial reception
of blunting member 70 (FIG. 2). Aperture 68 opens outwardly at one
end of shuttle 54 to define a frusto-conical region 69. Region 69
serves the dual purpose of facilitating insertion of the blunting
member into aperture 68 and of presenting a rim for the reception
of an annular bead of adhesive to bond the outer surface of the
blunting member to shuttle 54. Blunting member 70 is mounted in and
is disposed generally coaxially with shuttle 54 and preferably
extends both forwardly and rearwardly of shuttle 54. The portion of
blunting member 70 that extends forwardly of shuttle 54 is
preferably dimensioned and configured to be telescopically received
within the interior of needle 12 without obstructing the needle
component passageway to fluid flow therethrough. The rearwardly
extending portion of blunting member 70 may be received in the
aperture in driver 76 when driver 76 engages shuttle 54, as
described below.
[0079] Shuttle 54 comprises the blunting component hub for blunting
member 70 and together these structures comprise the blunting
component of the apparatus. A blunting component passageway extends
through shuttle 54 and blunting member 70.
[0080] Shuttle 54 defines a cam follower portion 59 that includes
first and second tines 60 and 62 having first and second following
surfaces 64 and 66, respectively. Each of first and second
following surfaces 64 and 66 preferably defines a surface which is
oriented perpendicularly to axis A-A and defines a helix about axis
A-A. Two tines acre not essential: a single tine and following
surface may be employed.
[0081] First and second following surfaces 64 and 66 are designed
for sliding engagement with complementary cam surfaces 82 and 84 on
cam member 80. When shuttle 54 engages cam member 80 and is
constrained for motion along axis A-A, the complementary cam and
following surfaces convert rotational motion of driver 76 about
axis A-A relative to both the needle component and to the blunting
member into translational motion of shuttle 54 along axis A-A. Such
constraint is achieved by disposing shuttle 54 and cam member 80 in
body 22 (FIG. 2), with spline 58 in cam channel 30. FIG. 5 depicts
driver 76 and shuttle 54 in axial alignment with hollow body 22.
Upon assembly, shuttle 54 and the blunting member 70 (FIG. 2)
attached thereto are inserted into cavity 24 with spline 58
disposed in cam channel 30. Then, cam member 80 is inserted into
cavity 24 such that first and second cam surfaces 82 and, 84,
respectively, mate with companion first and second following
surfaces 64 and 66 of cam follower portion 59. Then, lock tabs 44
snap into retention groove 88, thus rotatably coupling driver 76 to
body 22 so that cam member 80 can rotate within body 22.
[0082] Winged body 14 is illustrated in FIGS. 6A and 6B. Winged
body 14 comprises a generally cylindrical central member 15 having
a distal end 15a and a proximal end 15b. Central member 15 defines
distal locking ring 17 in its distal end 15a and a proximal locking
ring 19 in its proximal end 15b. Central member 15 of body 14 is
dimensioned and configured to fully receive hollow body 22 with
proximal end 15b and proximal locking ring 19 extending beyond the
proximal end 15b of hollow body 22. When cam member 80 of driver 76
is then inserted into hollow body 22, ring 19 can engage annular
trough 87 between rings 83 and 85 of driver 76, and sealingly
engage driver 76, e.g., at ring 83, while permitting rotational
movement between them. Winged body 14 will be sealingly secured to
hollow body 22, e.g., by a sealant/adhesive so the combination of
winged body 14, hollow body 22 and needle 12 may be viewed as
together constituting the needle component of the illustrated
embodiment.
[0083] The assembly of apparatus 10 (FIG. 1) may proceed as
follows. With reference now to FIG. 2, the end 12a of needle 12 is
secured in the distal end 22a of hollow body 22. Needle 12 is
inserted into cavity 24 at needle insertion funnel 40 until a
terminal end of needle 12 is seated within first cylindrical region
38 and abuts the hollow circular junction wall. The frusto-conical
shape of insertion funnel 40 facilitates alignment of needle 12
into cylindrical region 38, as disclosed in commonly assigned
patent application Ser. No. 08/772,002 of M. J. Burzynski et al for
"Self-Blunting Needle Medical Devices and Methods of Manufacture
Thereof". Needle 12 is fixed to hollow body 22 with a generally
annular film of adhesive disposed between the outer surface of
needle 12 and insertion funnel 40. Similarly, blunting member 70 is
inserted into shuttle 54 via region 69 and is secured therein
Blunting member 70 is then inserted into body 22. As mentioned
above, blunting member insertion funnel 34 facilitates insertion of
blunting member 70 into cylindrical region 36. Since the diameter
of region 36 is preferably substantially equal to or smaller than
the inner diameter of needle 12, funnel 34 and cylindrical region
36 cooperate to facilitate initial insertion of blunting member 70
within the interior of needle 12. The telescopically disposed
combination of needle 12 and blunting member 70 comprises the
cannula component of the apparatus. When blunting member 70 is
received within the needle 12, fluid flowing through the blunting
component passageway will also flow through the needle component
passageway. Thus, the blunting component does not obstruct fluid
flow through the needle component of the apparatus. In other
embodiments, the blunting component need not define a passageway
extending therethrough; it may be sufficient to provide an aperture
to allow fluid to enter the needle component passageway and for the
structures of the blunting component, e.g., the blunting member and
shuttle, to be physically configured to allow fluid to flow around
them within the needle component passageway. In still other
embodiments, the blunting component may both be dimensioned and
configured to define a blunting component passageway and to permit
fluid to flow around it within the needle component passageway. All
such configurations serve to permit the flow of fluid through the
needle and to permit the movement of the blunting component within
the needle component without obstructing or significantly affecting
fluid flow therethrough.
[0084] As blunting member 70 enters needle 12, shuttle 54 enters
cavity 24 with spline 58 in cam channel 30. Then, as indicated
above, cam member 80 of driver 76 is inserted into cavity 24 of
hollow body 22 so that cam surfaces 82 and 84 engage first and
second surfaces 64 and 66 of shuttle 54. Once driver 76 has been
fully received within hollow body 22, tabs 44 cooperate with a
circumferential retention groove 88 on driver 76 to rotatably
couple driver 76 with hollow body 22. The assembly of driver 76,
hollow body 22 and needle 12 may then be inserted into the proximal
end 114 of winged body 14 with needle 22 passing through the
internal passage therein so that rings 17 and 19 of winged body 14
engage hollow body 22 and driver 76, respectively.
[0085] As described above, spline 58 is initially disposed in
insertion channel 26 and it has been shown that apparatus 10 is
configured to permit rotational movement of driver 76 relative to
the needle component and to shuttle 54 and blunting member 70,
which are movable relative to the needle component. When driver 76
is rotated by the manipulation of third wing 78, the complementary
cam surface/following surface engagement of cam member 80 and
shuttle 54 will tend to advance shuttle 54 within body 22. The user
thus advances the blunting component in an axial direction by
applying a rotational force to the apparatus. Such advancing
movement will be constrained by the spline-and-cam channel
engagement of the blunting component and the needle component of
the apparatus, i.e., of shuttle 54 and hollow body 22. The
resulting motion of spline 58 will be in an axial direction along
insertion channel 26, then in a lateral or rotational direction
into and through first lateral channel 28, guided by slide surface
28b.
[0086] Thereafter, further rotation of cam member 80 in body 22
advances shuttle 54 towards the distal end 22a of body 22 along
axis A-A within guide channel 31. Blunting member 70 is dimensioned
so that as shuttle 54 advances within hollow body 22 towards distal
end 22a, the blunt end of blunting member 70 does not protrude
beyond the puncture tip at puncture tip 13 of needle 12 at least
until spline 58 enters guide channel 31 (FIGS. 4A and 4B). Further
rotation of driver 76 will cause spline 58 to move forward axially
in guide channel 31 and then laterally or rotationally into second
lateral channel 32. It should be noted that first tine 60 of
shuttle 54 (and first following surface 64 thereon) is longer than
second tine 62 and second following surface 66. Similarly, first
cam surface 82 of cam member 80 is longer than second cam surface
84. Cam surface 82 and following surface 64 are dimensioned and
configured to generate axial and rotational movement of shuttle 54
as driver 76 rotates in the direction of arrow B about axis A-A. By
the time spline 58 is aligned with second lateral channel 32, the
shorter of the complementary surfaces (second cam surface 84 and
second following surface 66) will no longer be in contact with one
another and further motion of shuttle 54 will be due to the
engagement of first cam surface 82 and first following surface 64.
However, once first cam surface 82 causes shuttle 54 to rotate so
that spline 58 enters second lateral channel 32, reverse rotation
of driver 76 will disengage the complementary cam/following
surfaces, leaving spline 58 positioned within second lateral
channel (or "catch portion") 32 between forward stop surface 32a
and rearward stop surface 32b. Thus, upon complete extension of
blunting member 70, third wing 78 will become rotatable
independently of shuttle 54. Further, shuttle 54 will be incapable
of further movement along axis A-A either in the direction of, or
opposite to that of, arrow C. Backward axial movement of shuttle
54, which may be imposed if the blunted apparatus accidentally
contacts a user's skin, will then cause spline 58 to engage surface
32b. If spline 58 slides along surface 32b, surface 32b will guide
spline 58 away from guide channel 31, towards axial surface 32c.
The blunting component is configured so that even if spline 58
retreats as far as surfaces 32b and 32c will allow, it will still
extend beyond the tip of the needle and blunt the apparatus.
Accordingly, once spline 58 has entered second lateral channel 32,
it will be "locked" therein against axial movement within body 22
until and unless shuttle 54 is rotated within hollow body 22 to
realign spline 58 with guide channel 31.
[0087] In alternative embodiments, the spline may be mounted on the
body member and the channel may be formed in the shuttle. Thus, in
a spline and channel configuration, either one of the shuttle and
the body member may comprise the spline and the other may comprise
the channel. Alternative locking means, such as a groove and lock
tab arrangement comparable to tabs 44 and retention groove 88 may
be employed, if desired. Optionally, the apparatus may comprise
unlocking means for moving the spline from the locked position back
into alignment with guide channel 31 and, optionally, for
retracting the blunting member to return the apparatus to the
insertion configuration. In various embodiments, the needle could
be mounted on the shuttle and extend into the blunting member,
which would be mounted on the hollow body. In such case, the
initial insertion configuration would require that the shuttle
start at the distal end of the hollow body, and the action of the
driver would be to retract the shuttle towards the proximal end to
withdraw the puncture tip behind the blunt end of the blunting
member. The complementary cam/following surfaces and the
orientation of the locking means would have to be reversed relative
to apparatus 10.
[0088] Those of ordinary skill in the art will appreciate that a
wide variety of other cam member/cam follower configurations could
also be employed to translate the rotation of driver 76 into axial
movement of shuttle 54. For example, while cam member 80 and
follower portion 59 provide two pairs of complementary
cam/following surfaces, other embodiments can function similarly as
long as there is at least one pair of complementary surfaces.
[0089] Referring again to FIGS. 1 and 2, the central portion 15 of
winged body 14 serves the advantageous purpose of ensuring that no
air seeps into the fluid which flows through apparatus 10 during
fluid transfer. Such air seepage is undesirable, for example,
because it causes foaming of a fluid sample as the fluid is drawn
into the fluid reservoir. In particular, central member 15 is
disposed around winged body 14 in a manner which prevents air from
being drawn into an associated fluid reservoir through the space
between the various adjoining components (e.g., driver 76 and
hollow body 22) during blood collection operations. Air seepage is
inhibited at one end of apparatus 10 by the engagement of rings 85
of winged driver 76 and the corresponding ring 19 on winged body 14
(FIGS. 6A and 6B), which form an air-tight seal between them.
Similarly, ring 83 bears against central member 15 to form a seal
therebetween. Air seepage is prevented at the other end of
apparatus 10 by cooperation between ring 17 (FIGS. 6A and 6B) on
winged body 14 and an annular wall 37 (FIG. 4A) on hollow body 22,
which form an air-tight seal therebetween as well. Component
sealing can optionally be enhanced by applying viscous
lubricant/sealant to the components of apparatus 10. In particular,
the lubricant/sealant can, inter alia, be applied to an annular
trough 87 of driver 76.
[0090] When apparatus 10 is fully assembled (as seen in FIGS. 1 and
3), driver 76 is rotatably coupled to the needle component and the
passageway 86 extending through it communicates with the needle
component passageway. Thus, driver 76 and the needle component are
disposed in a tandem configuration, in which fluid enters one of
these two and can then flow through the next. The blunting
component is disposed substantially entirely within the needle
component because the blunting member hub, i.e., shuttle 54 and the
forward portion of blunting member 70, are disposed within the
needle cannula 12 and the needle hub, i.e., hollow body 22. Fluid
can flow through the apparatus in either direction, i.e., into
proximal aperture 86b (FIG. 5), through the fluid flow passageway
of the device (i.e., through driver 76, through the blunting
component and through the needle component) and out needle 12 or in
the opposite direction, into needle 12, through the apparatus and
out proximal aperture 86b. In addition, the needle component and
blunting component will be movable relative to each other, from an
insertion configuration in which the puncture tip at the puncture
tip of needle 12 extends beyond the blunt end of the blunting
member to a blunted configuration in which blunting member 70
protrudes past the puncture tip to blunt the apparatus. Typically,
such movement will entail the sliding advancement of blunting
member 70 through needle 12. Optionally, blunting member 70 may be
configured to leave an annular space between it and the interior
surface of needle 12, and apparatus 10 may include a viscous,
optionally silicone (polymeric organo-silicon)-based,
lubricant/sealant disposed at least between the inner surface of
needle 12 and the outer surface of blunting member 70. A bead of
such lubricant/sealant may be deposited around blunting member 70
so that it is disposed at insertion funnel 34 of cavity 24 in body
22, where it serves as a small reservoir to coat and seal blunting
member 70 as it moves into needle 12.
[0091] As indicated above, one end of collection tube 72 is
preferably connected to driver 76 such that tube 72 is in fluid
communication with passageway 86 (see FIG. 5) at proximal aperture
86b. Since tube 72 (FIG. 3) terminates at luer adapter 74, fluid
communication between tube 72 and one of a wide variety of
well-known fluid reservoirs having a standard luer adapter fitting
thereon is possible. Alternatively, luer adapter 74 could be
replaced by another fitting to accommodate other fluid reservoirs,
or passageway 86 (FIG. 5) could be directly connected to another
type of fluid flow apparatus.
[0092] In apparatus 10, first and second wings 16 and 18
effectively act as stops which limit the rotation of third wing 78,
which serves as an actuator by which the user can conveniently
rotate driver 76. Thus, third wing 78 is capable of rotational
movement about axis A-A between a first position, wherein third
wing 78 is adjacent first wing 16 (see FIGS. 1 and 3), and a second
position wherein third wing 78 is adjacent second wing 18. During
one method of usage, it is customary to fold first and second wings
16 and 18 toward one another just prior to and during venipuncture.
If this procedure is utilized, third wing 78 will naturally be
urged into a position which is midway between the above-described
first and second positions. In order to accommodate this customary
practice, cam member 80 and cam follower portion 59 of shuttle 54
are preferably designed such that rotation of third wing 78 from
the first position to the above-described midway position does not
impart substantial axial motion to shuttle 54 along axis A-A, i.e.,
such movement is not sufficient to move the apparatus from the
insertion configuration to the blunted configuration. Thus, during
venipuncture, blunting member 70 will not extend forwardly of
puncture tip 13 of needle 12. Wings 16 and 18 and even third wing
78 therefore provide a non-deploying haft, meaning that even when
they are displaced (i.e., in the case of wings 16 and 18, folded
together) from their "neutral" or flat configuration to an upright
configuration, they do not deploy the blunting member or blunt the
needle. Stated in the converse, in this embodiment the deployment
means effects deployment of the blunting member independently of
the use of the haft. After insertion of needle 12, however, first
and second wings 16 and 18 may be relaxed to their original
position and third wing 78 will be rotated from the midway position
to the above-described second position. During this rotation of
third wing 78, shuttle 54 is urged from its retracted positioned
(the insertion configuration) to its extended position (the blunted
configuration) to thereby blunt needle 12. Alternatively, the user
may grasp third wing 78 for use as a haft to effect insertion of
needle 12. In such case, third wing 78 will be disposed in an
upright position, midway between wings 16 and 18, which lie flat
and act as guides against the patient's skin. Even in such use,
third wing 78 is held in the midway position and does not blunt the
needle until it is rotated to its second position. After deployment
of the blunting member, third wing 78 can be freely rotated about
axis A-A either in the direction of, or opposite to, arrow B
without imparting movement to shuttle 54. Thus, first and second
wings 16 and 18, together with third wing 78, may be securely taped
to a patient during fluid delivery and/or withdrawal operations in
the usual manner. Since blunting member 70 is locked in a forwardly
extending position due to the cooperation of spline 58 and second
lateral channel 32, apparatus 10 may be subsequently untaped,
removed from the patient and discarded without exposing a
healthcare worker to the sharpened puncture tip 13 of needle
12.
[0093] The various components of apparatus 10 may be fabricated
from a wide variety of materials. For example, needle 12 and
blunting member 70 may be formed of stainless steel or some other
corrosion-resistant metal. Further, hollow body 22, shuttle 54 and
winged driver 76 are preferably formed of one of the many durable,
semi-rigid, and moldable plastic materials. Winged body 14, by
contrast, is preferably formed from a thermoplastic elastomeric
material. Using such a relatively pliant material to form winged
body 14 serves the dual purpose of allowing wings 16 and 18 to be
freely flexed and of ensuring that central member 15 of winged body
14 provides an air-tight seal around hollow body 22. Any one of a
number of well-known adhesives may be used to affix needle 12 to
hollow body 22 and to affix blunting member 70 to shuttle 54.
[0094] In alternative embodiments, needle apparatuses in accordance
with the present invention may comprise various types of locking
mechanisms. For example, the locking means for an apparatus in
accordance with the present invention may comprise a sliding
locking member such as a chuck 79 mounted thereon. FIG. 6C shows a
needle apparatus comprising a winged body 14 having a first wing
(not shown) and a second wing 18 and a driver 76 rotatably coupled
thereto. Driver 76 carries a third wing 78 that provides an
actuator to be manipulated by the user to deploy the blunting
member as described above, except that in the embodiment of FIG.
6C, driver 76 does not disengage from the blunting member during
reverse rotation. However, winged body 14 carries on it a slidably
disposed chuck 79 which, in the forward position shown in FIG. 6C,
remains clear of third wing 78. When third wing 78 is moved against
wing 18 as shown in FIG. 6C to deploy the blunting member of the
device, the user may slide chuck 79 rearward so that third wing 78
is disposed within gap 79a of chuck 79, as suggested in dotted
outline. So positioned, chuck 79 will inhibit the reverse rotation
of third wing 78 and help prevent inadvertent re-sharpening of the
needle. Alternatively, wing 78 may carry a slidable clip member
(not shown) that can be moved into place to engage wing 18 when
wing 78 is disposed against it as shown in FIG. 6C.
[0095] As alluded to above, the locking spline and cam channel
engagement between the blunting component and the needle component
shown in FIG. 3A and FIG. 5 can be employed advantageously in
apparatuses other than flow-through, winged needle apparatuses,
regardless of whether the blunting component obstructs fluid flow
when deployed or whether the blunting component comprises an
oblique motion deployment means. For example, the spline and cam
channel engagement could be incorporated into a self-blunting
syringe in place of a tooth-and-groove arrangement shown in U.S.
Pat. No. 4,828,547 (discussed above) or a detent-and-shoulder or a
snap ridge-and-groove arrangement as shown for a syringe plunger in
U.S. Pat. No. 5,527,284 to Ohnemus et al, dated Jun. 18, 1996. For
example, syringe 110 shown in FIG. 6D comprises a syringe barrel
120 which is intended to hold an injectable fluid to be
administered through the movement of plunger head 130 therethrough.
A plunger arm 126 is connected to plunger head 130 and terminates
in a thumb rest (not shown) that is accessible from outside barrel
120 and upon which the user presses the thumb while holding the
fingers against a finger rest (not shown) on barrel 120. A needle
112 is mounted in a hub portion that comprises needle mount 116,
the barrel 120 on which it is mounted and the hollow body 122
secured therein. A blunting member 170 is disposed movably within
the needle component and extends telescopically within syringe 110.
Blunting member 170 comprises a shuttle 154. Hollow body 122 is
dimensioned and configured to receive shuttle 154 therein and to
engage shuttle 154 in a spline and cam channel configuration.
Accordingly, shuttle 154 comprises a spline 58 and hollow body 122
comprises a cam channel configured substantially like cam channel
30 of hollow body 22 (FIGS. 4A and 4B) except that the cam channel
of hollow body 122 comprises a slide surface 228 leading to the
second lateral channel of the cam channel. The blunting component
of syringe 110 comprises blunting member 170, shuttle 154 and the
driving means movable relative thereto, i.e., a plunger comprising
plunger head 130 and plunger arm 126. The driving means engages the
needle component at the interior of barrel 120. When initially
assembled, syringe 112 is filled with injectable fluid and the
apparatus is disposed in the insertion configuration, i.e.,
blunting member 170 is retracted within needle 112 by positioning
shuttle 154 near the proximal end 122b of hollow body 122. The user
manipulates the driving means, i.e., depresses plunger arm 126, to
make plunger head 130 bear against blunting member 170 to move it
towards its extended position, i.e., into the blunting
configuration, and to advance spline 58 through the cam channel of
hollow body 122. As this occurs, the plunger forces the injectable
fluid in barrel 120 through needle 112. When the injection is
complete, spline 58 is disposed within the second lateral channel
of hollow body 122, thus locking the syringe 110 in the blunted
configuration. Shuttle 154 and blunting member 170 are configured
to permit fluid flow around and/or through them, through hollow
body 122 and needle 112, respectively. Optionally, the portion of
blunting member 170 that resides in barrel 120 may be perforated to
allow the injectable fluid in barrel 120 to enter the hollow
interior of blunting member 170. Syringe 110 thus provides an
embodiment of the present invention in which the spline and cam
channel locking means is utilized with a blunting component that
comprises a hydraulic driver instead of a non-hydraulic driver.
Optionally, blunting member 170 may be configured so that it does
not enter needle 112 until the intended dose of fluid in barrel 120
has entered the proximal end 112a of needle 112. In such case, the
blunting component 170 need not necessarily comprise a
nonobstructive blunting component.
[0096] An alternative preferred embodiment of the present invention
is depicted in FIG. 7. While the alternative embodiment of FIG. 7
contains a cam/cam follower configuration which is distinctly
different from that of the above-discussed preferred embodiment,
the embodiment of FIG. 7 also bears a number of similarities with
the above-discussed discussed referenced embodiment. For example,
apparatus 10' comprises a winged body 14', a blunting member
shuttle 54', a blunting member 70', a winged driver 76' and a
needle 12'. In this embodiment, winged body 22' integrates the
salient features of winged body 14 and hollow body 22 of the
previously described embodiment. Thus, winged body 22' defines a
generally cylindrical hollow cavity 24' extending axially along an
axis A'-A' and has first and second wings 16' and 18' that extend
from opposite sides thereof. Needle 12' is fixed to the distal end
22a' of winged body 22' such that needle 12' extends forwardly of
the distal end of winged body 22', which serves as the needle hub.
The needle component of this embodiment is therefore constituted by
winged body 22' and needle 12'. Winged body 22' forms a cavity 24'
that defines a cam channel 30' which extends therein parallel to
axis A'-A'. Blunting member shuttle 54' is generally cylindrically
shaped and includes an elongated spline 58' which is complementary
in cross section to cam channel 30' for slidable engagement
therewith. Shuttle 54' is disposed about a tubular blunting member
70' such that, when shuttle 54' is received within cavity 24',
blunting member 70' extends along axis A'-A' and is telescopically
received within needle 12'. Shuttle 54' may move between a
retracted position, wherein blunting member 70' does not extend
forwardly of puncture tip 13' of needle 12' and an extended
position, wherein blunting member 70' does extend forwardly of the
puncture tip 13' of needle 12'. Also, shuttle 54' includes a cam
follower portion 59' with a planar elliptical surface disposed on
the rearward face of shuttle 54". Blunting member 70' and shuttle
54' constitute the blunting component of this apparatus.
[0097] As with the above-described preferred embodiment, the
embodiment of FIG. 7 further comprises driver 76' having a third
wing 78' and a generally cylindrical cam member 80'. Cam member 80'
is sized and shaped to be received within cavity 24' and includes a
passageway 86' extending therethrough for receiving the rear end of
blunting member 70'. Cam member 80' also includes a substantially
elliptical camming surface which faces the cam follower portion 59'
of shuttle 54'. As shown in FIG. 7, driver 76' is capable of
rotation about axis A'-A' in the direction of arrow B' between a
first position, wherein third wing 78' lies immediately adjacent
second wing 18' and a second position, wherein third wing 78' lies
immediately adjacent first wing 16'. Driver 76' may be sealingly
but rotatably connected to body 22' by complementary rings and
grooves (not shown) as described above for apparatus 10' in tandem
relation to the needle component. Those of ordinary skill will
readily appreciate that upon rotation of third wing 78' from the
first position to the second position, the rotational movement
thereof will impart linear movement to blunting member shuttle 54'
along axis A'-A' in the direction of arrow C'. Naturally, such
movement of shuttle 54' will also blunt needle 12' by urging
blunting member 70' forwardly of puncture tip 13' of needle 12'.
Thereafter, third wing 78' is freely rotatable about axis A'-A'
between the first and second positions without imparting further
movement to shuttle 54'.
[0098] The embodiment of FIG. 7 may also include a variety of
features previously described with respect to the above-discussed
preferred embodiment. These features may include a blunting member
locking mechanism, means for retaining blunting member shuttle 54'
and cam member 80' within hollow cavity 24', and the presence of a
viscous lubricant/sealant between needle 12' and blunting member
70'. Additionally, the various apertures may include any one or
more of the contoured features of hollow body 22' which facilitate
assembly of apparatus 10' as described above. It should be noted
that the rotatable driver and shuttle member may be configured to
rotate about the longitudinal axis of the apparatus in either
direction, with wing 78' moving from right to left (as sensed and
shown in FIG. 7) or from left to right to deploy the blunting
member. Finally, the various components of apparatus 10' may be
fabricated from the various materials discussed above with respect
to the components of apparatus 10'.
[0099] In apparatuses 10 and 10', the illustrated blunting
components are dimensioned and configured to have a flow aperture
therethrough. Such a configuration of the blunting component,
however, is not a necessary limitation for such embodiments of the
invention; the present invention would encompass a similar
embodiment in which, e.g., the blunting member had a solid cross
section but was dimensioned and configured to permit fluid flow
around it within the needle component. For example, even if the
blunting member and shuttle are solid and configured for a friction
fit within the needle and hub, they may make only partial contact
with the interior of the needle component by virtue of, e.g.,
generally longitudinal (axial) flutes or grooves along its surface,
to permit fluid flow around the blunting component rather than
through it. In any case, the blunting component of the present
invention is configured so that it does not obstruct the flow of
fluid through the flow passageway of the apparatus in either the
insertion configuration or the blunted configuration.
[0100] Another aspect of apparatuses 10 and 10' is that the winged
bodies, which are designed to provide a convenient handling aid to
facilitate venipuncture, effectively comprise parts of the needle
components of those apparatuses. In alternative embodiments, the
handling wings or other feature intended to facilitate handling may
comprise part of the blunting or the optional driving means.
[0101] As previously indicated, various aspects of the present
invention are not limited to wing set embodiments. For example,
FIGS. 7B through 7H illustrate a blood collection needle 200 that
embodies various aspects of the present invention. Blood collection
needle 200 comprises a self-blunting needle assembly 202, a holder
214, an inner sleeve 254 and a driver 276. The self-blunting needle
assembly 202 provides a cannula component comprising a needle
cannula and a blunting member disposed telescopically one within
the other with the two being movable between a sharpened
configuration and a blunted configuration. In the sharpened
configuration, the sharp tip of the needle cannula extends beyond
the blunt tip of the blunting member; in the blunted configuration,
the blunt tip of the blunting member extends beyond the tip of the
needle cannula and thus prevents the needle from puncturing tissue
under typical hand pressure. Needle assembly 202 is shown in
greater detail in FIGS. 7C and 7D, which shows that needle cannula
212 is mounted in a hub body 222 to provide a needle component for
the device. The blunting member 270 is hollow, defines a blunt tip
270a, and is disposed telescopically within the needle cannula 212.
Blunting member 270 carries thereon a nut 270b that defines annular
grooves 270c and 270d. The hub body 222 defines detents 222a, 222b
on flex arms 222e and 222f that cooperate with annular grooves 270c
and 270d to define preferred rest positions for the blunting member
relative to the needle component corresponding to the blunted
configuration and the sharpened configuration. Hub body 222 defines
a threaded portion 222c by which the needle component is mounted on
holder 214 in a conventional manner and an open internal bore 222d
which at least partially includes a mounting passage 222d within
which needle 212 is mounted. Preferably, but optionally, passage
222d defines at least one, preferably two, divergent openings at
its ends that are dimensioned and configured in a funnel-like
manner to facilitate the mounting of needle cannula 212 in hub 222
and/or the insertion of blunting member 270 into needle cannula
212. Optionally, passage 222d and the divergent opening(s) thereto
may be formed in a ferrule 222e that is mounted in an open internal
bore formed in hub 222, as shown. Alternatively, passage 222d and
its divergent opening(s) may be formed integrally with hub 222.
Blunting member 270 terminates at a sharpened tip 270e that is
covered by a resilient, puncturable and self-sealing boot 270f. As
is well-known in the art, boot 270f prevents the leakage of blood
from needle assembly 202 when needle cannula 212 is inserted into a
patient's vein and before a blood sample vial is secured thereto.
Boot 270f forms an anchor region 270g that has a greater outer
diameter than the rest of boot 270f because it rests on an anchor
ferrule 270h on nut 270b. Part of nut 270b forms an annular cup
270j into which anchor ferrule 270h and boot 270f extend. Anchor
region 270g grips ferrule 270h in a friction fit to inhibit removal
of boot 270f therefrom, and cup 270j may be crimped onto boot 270f
for added stability. Tip 270e permits blunting member 270 to
puncture boot 270f and the seal on a conventional sample vial as in
a manner known in the art.
[0102] Referring again to FIG. 7B, self-blunting needle assembly
202 is mounted on holder 214 which serves as a haft because it is
customary in the field of phlebotomy to manipulate the needle
cannula by grasping the holder. Self-blunting needle assembly 202
is mounted at the distal or forward end 214a of holder 214, i.e.,
at the end which, in use, is generally directed away from the user.
Holder 214 defines an interior region dimensioned and configured to
receive therein the inner sleeve 254 into which the sharpened end
of the blunting member extends. Inner sleeve 254 is dimensioned and
configured to receive therein a conventional blood collection vial
or "sample vial" which typically comprises a stoppered evacuated
sample tube.
[0103] Inner sleeve 254 is dimensioned and configured to be
slidably received within holder 214. Inner sleeve 254 defines one
or more tabs 258 that protrude from the exterior surface of inner
sleeve 254. The interior of holder 214 is dimensioned and
configured to slidably receive tabs 258 and to limit the movement
of inner sleeve 254 within holder 214 to axial relative motion and
to prevent rotation of inner sleeve 254 within holder 214. To
accommodate tabs 258 in this way, holder 214 may define wings
214c.
[0104] At the rearward end 214b, holder 214 defines an internal
engagement lip 219 for engaging driver 276 as described below.
[0105] Driver 276 is now described with reference to FIG. 7E.
Driver 276 comprises a generally annular body 283 and a
radially-extending flange 278 which the user can employ as an
actuator to rotate the driver 276. Body 283 is dimensioned and
configured to be received within the rearward end of holder 214 and
to receive therein a sample vial. The exterior surface of body 283
defines one or more cam channels 283a. Body 283 and tabs 258 (FIG.
7B) are dimensioned and configured so that body 283 can be received
between tabs 258 and lugs 264 can be slidably disposed within cam
channels 283a.
[0106] To assemble the device, needle assembly 202 is mounted in
holder 214. Inner sleeve 254 is then inserted into the interior of
holder 214 and inner sleeve 254 engages the blunting component 270.
The body 283 of driver 276 is then inserted into the rearward end
214b of holder 214 and is received between tabs 258 with lugs 264
disposed within cam channels 283a. Body 283 is inserted into holder
214 until engagement lip 219 engages groove 287 to rotatably retain
driver 276 therein. Then, by grasping holder 214 in one hand and
flange 278 of driver 276 in the other hand, the user can rotate
driver 276 and, due to the cam action of tabs 258 in cam grooves
283a, can move the needle assembly 202 from a sharpened
configuration shown in FIG. 7F to the blunted configuration shown
in FIG. 7G by advancing and retracting inner sleeve 254 and the
blunting member secured thereto within holder 214. The illustrated
blood collection needle thus embodies an oblique motion deployment
means and a driver that rotatably engages the haft member.
[0107] A particular embodiment of a blood collection needle as
described above is illustrated in FIG. 7H. Blood collection needle
200' comprises a holder 214' within which the self-blunting needle
assembly 202 is mounted. Holder 214' optionally comprises a
quick-release mechanism 200a' for the convenient disposal of needle
assembly 202 when blood sampling is complete. Alternatively, needle
assembly 202 can be screwed or otherwise secured into a
conventional holder fitting. Mechanism 200a' is not part of the
present invention per se, so it will not be described herein.
However, reference may be made to U.S. Pat. No. 5,755,673, dated
May 26, 1998, which patent is incorporated herein by reference for
background purposes with respect to the detailed description of the
quick-release mechanism described therein. The needle cannula of
needle assembly 202 and holder 214' are co-axially aligned.
[0108] Holder 214' defines a substantially cylindrical interior
cavity within which a generally cylindrical inner sleeve 254' is
disposed. The forward end 254a' of inner sleeve 254' is dimensioned
and configured for a friction fit with cup 270j of nut 270b and is
thus coupled with blunting member 270 so that axial movement of
inner sleeve 254' within holder 214' is effective to move needle
assembly 202 between the sharpened and blunted configurations.
[0109] A driver 276' comprises a generally annular body 283' and a
radially-extending flange 278', and it engages a retaining lip 219'
formed on holder 214'. When driver 276' thus rotatably engages the
rearward end of holder 214', lugs 264' carried on driver 276'
engage cam grooves 283a' in holder 214'. Thus, the user can move
needle assembly 202 between the sharpened configuration and the
blunted configuration by rotating driver 276' about the axis of the
needle to move inner sleeve 254'. Cylindrical body 283' and inner
sleeve 254' are dimensioned and configured to receive a standard
blood collection vial therein.
[0110] In use, the user grasps holder 214' to insert the sharpened
needle cannula into the patient's vein before inserting the sample
vial into the holder 214'. At any convenient juncture thereafter,
the user may rotate driver 276' to move the needle assembly 202 to
the blunted configuration. The user inserts a standard blood
collection vial through the hollow interior of body 283' and inner
sleeve 254' so that the stopper on the vial presses against boot
270f. The pressure on boot 270f causes the sharp tip on blunting
member 270 to penetrate the boot 270f and the stopper on the vial,
which is typically evacuated. Blood is then drawn through the
needle assembly 202 into the vial. When the vial is full or a
suitable volume of blood has been drawn, the vial may be withdrawn
from holder 214'. Boot 270f will return to its initial
configuration, effectively sealing the blunting member 270 and thus
preventing unwanted flow of blood through the needle assembly until
a subsequent sample vial is inserted into holder 214' or until the
blood collection needle 200' is withdrawn from the patient's
vein.
[0111] Apparatus 10a of FIG. 8 exemplifies another embodiment of
the present invention. Apparatus 10a comprises a needle component
comprising needle 12 that is secured to a hub portion comprising a
winged body 14a. Winged body 14a comprises a central member 15'
that serves the same purpose as hollow body 22 of apparatus 10
(FIG. 2). In contrast to the previously described embodiments, it
is the needle component of apparatus 10a that is configured to be
coupled with a fluid flow device. Thus, central member 15' defines
a passage therethrough that communicates and flows into the hollow
interior of needle 12. In addition, central member 15' comprises a
needle component end 15a that is dimensioned and configured to be
coupled to a flow device such as a tube, luer, or the like.
[0112] The blunting component of apparatus 10a comprises a blunting
member 70 (shown in dotted outline) which is slidably disposed
within the needle 12. In FIG. 8, the apparatus 10a is shown in the
insertion configuration, i.e., blunting member 70 is withdrawn into
entry needle 12 such that the puncture tip is fully exposed.
Blunting member 70 comprises a shuttle portion (not shown) that is
disposed within central member 15'. The blunting component is
dimensioned and configured to permit fluid flow between needle
component end 15a and the puncture tip of needle 12 at all times.
The shuttle portion of the blunting component comprises a lug 92
that protrudes through an access aperture in the form of a lug slot
94 formed in central member 15'.
[0113] As used herein, the term "access aperture" refers to a slot
or other opening in the needle component or the blunting component
that exposes a portion of the other component therein without
permitting biologic fluid to flow through the aperture. For
example, the outer surface of the blunting component seals off the
lug slot 94 by engaging the inner surface of central member 15'
even though lug 92 protrudes therethrough. Referring now to FIG.
8A, slot 94 comprises an axially-oriented travel portion 94a and a
catch portion 94b. Travel portion 94a extends for an axial distance
sufficient to allow spline 58 to move from its retracted position
to its extended position, i.e., from the insertion configuration to
the blunted configuration. At the apex of such motion, shuttle 58
engages diversion surface 94c, which is disposed in oblique
relation to travel portion 94a, and which causes the shuttle (not
shown) to rotate within central member 15' so that spline 58 enters
catch portion 94b. Catch portion 94b is bounded in part by a stop
surface 94d which will prevent a direct reverse axial force from
moving spline 58 (and therefore the blunting component of the
apparatus) back into the retracted (i.e., insertion) position.
Accordingly, spline 58 and slot 94 provide an alternative
embodiment of locking means in accordance with the present
invention.
[0114] Referring again to FIG. 8, apparatus 10a comprises
deployment means comprising a tension line 90, which may comprise a
nylon filament, metal wire, or other flexible high tensile strength
fiber. Tension line 90 is anchored at one end on wing 16 at an
anchor 90a which may comprise a spot of adhesive or any other
suitable device for anchoring the end of line 90 on wing 16. The
other end of line 90 is anchored at a corresponding anchor 90c on
wing 18, and the middle of line 90 is secured to spline 58. Anchors
90a and 90c are situated forward of the initial position of lug 92.
Winged body 14a is configured so that wings 16 and 18 fold along
hinge lines disposed on the bottom of winged body 14a while spline
58 extends beyond the blunt end of the blunting member at the top
of winged body 14a. Wings 16 and 18 are initially constrained in a
folded, upright manipulation position that facilitates handling the
needle cannula venipuncture, and line 90 is configured so that as
long as the wings are in this folded, initial configuration, spline
58 can remain in the retracted position. When wings 16 and 18 are
folded down after venipuncture by the user's application of
generally lateral forces thereon, the separation of the anchors
draws line 90 taut, pulling spline 58 forward into the extended
position, as shown in FIG. 8B. Thus, folding down the wings moves
the apparatus from the insertion configuration to the blunted
configuration.
[0115] As indicated above, a deployment means is an optional
feature used only in certain embodiments of the present invention;
in other embodiments, an apparatus according to the present
invention may simply comprise the needle component and the blunting
component. Such an embodiment is represented by apparatus 10b shown
in FIG. 9. Apparatus 10b comprises a needle 12 connected to a
winged body 14b which together comprise a needle component which is
the outer component of apparatus 10b. Blunting member 70 and the
shuttle (not shown) on which it is mounted therein comprise the
inner component. In this embodiment, the outer component, i.e., the
needle component, not only defines a first aperture, i.e., the
opening of the needle cannula at the sharp puncture tip, but it
also provides a second aperture 186b to which other fluid flow
devices can be attached. Accordingly, the outer (needle) component
encloses the inner (blunting) component, and the apparatus
establishes a fluid flow passageway from the first aperture to the
second aperture. The outer component further defines an opening or
access aperture through which the user can manipulate the inner
component. Specifically, winged body 14b defines an
axially-oriented slot 94'. The shuttle therein carries a lug 92
that protrudes through the access aperture provided by slot 94' and
which can be manipulated by the user, e.g., pushed with a finger in
a forward axial direction to advance the blunting component of the
device, i.e., to apply force in the direction in which the needle
was inserted. Preferably, the blunting component is rotatable
therein and apparatus 10b comprises locking means comprising a
catch portion of slot 94' similar to that shown in FIG. 8A. When it
is desired to lock the blunting component in the extended position,
lug 92 is rotated so that it engages the catch portion of the slot.
The blunting component will then resist backwards motion until the
user once again aligns lug 92 with the main portion of the slot. In
an alternative embodiment, the lug itself is rotatable. Such a lug,
e.g., lug 92a (FIG. 9A), can be rotated when in the extended
position to engage catch portion 94b of slot 94a.
[0116] According to still other embodiments of this invention, the
deployment means may comprise a pliant or deformable portion of the
outer component, and the inner component may be configured to move
therein in response to deformation of the outer component. For
example, apparatus 10c (FIG. 10) comprises a blunting component
that is entirely disposed within the needle component when the
apparatus is in the insertion configuration. In apparatus 10c,
winged member 14c comprises a manually deformable central member
15'" in which needle 12 is mounted and which comprises an end 15c
that provides a proximal aperture to which a fluid flow device may
be connected. The shuttle portion 54a and the interior of central
body member 15'" are configured so that after venipuncture, the
user may apply lateral or radial force on the apparatus by
squeezing body member 15'" of winged body 14c and may thus urge
shuttle portion 54a and the blunting member 70 thereon forward,
i.e., away from end 15c, to project the blunt end of blunting
member 70 beyond the puncture tip of needle 12. For example,
shuttle portion 54a may have a tapered configuration that narrows
towards end 15cShuttle portion 54a and blunting member 70 are
configured to permit fluid flow through the needle component at all
times. For example, they may define a blunting component passageway
therethrough.
[0117] Another apparatus comprising a deployment means comprising a
deformable outer component in accordance with the present invention
is shown in FIG. 11. Apparatus 10d comprises a needle 12 mounted in
a hub comprising winged body 14d. Blunting member 70 is mounted in
a blunting component hub that provides a piston 54b. Rearward of
piston 54bwinged body 14d defines a pliant portion 15d that defines
a fluid reservoir for a working fluid 15e sealed therein between
piston 54b and the slidable sealed engagement region 15f of
blunting member 70 and winged body 14d. Since blunting member 70
never leaves engagement region 15f and piston 54b forms a seal with
winged body 14d, working fluid 15e resides only outside blunting
member 70 and is thus isolated from the flow passageway of the
apparatus. The flow passageway of the apparatus extends from the
proximal aperture into the blunting member, through piston 54b and
to the distal aperture of needle 12. After venipuncture, the user
can squeeze pliant portion 15d to cause working fluid 15e to
advance piston 54b (and therefore the blunting member) forward
without significant hydraulic effect on biologic fluid in the flow
passageway of the apparatus. Internal stop lugs 15g prevent piston
54b from moving so far forward that blunting member 70 is withdrawn
from engagement region 15f. It may be noted that the wings may be
folded for venipuncture without compressing pliant portion 15d.
[0118] Yet another embodiment of the invention is illustrated in
FIG. 12. In this Figure, apparatus 10e comprises a needle component
comprising needle 12 and a needle hub comprising winged body 14e.
The blunting component comprises blunting member 70 and blunting
component hub 54c, which protrudes from the end of winged body 14e.
Hub 54c comprises a collet portion 54d that is dimensioned and
configured for convenient manipulation by the user. Hub 54c is also
dimensioned and configured to define the proximal aperture of the
apparatus 10e, for convenient coupling with a fluid flow device
such as a tube 72 (FIG. 1). Hub 54c also comprises a threaded
portion 54e that engages complementary threads (not numbered)
within winged body 14e. In use, apparatus 10e is initially in the
insertion configuration, as shown in FIG. 12, and the user handles
wings 16a and 18a for venipuncture. Then, the user can manipulate
the collet portion 54d to move the apparatus to the blunted
configuration, in which the blunt end of blunting member 70
protrudes beyond the puncture tip of needle 12. To accomplish this,
the user rolls collet portion 54d between the thumb and index
finger, thus screwing the blunting component into winged body 14e
and advancing blunting member 70 into needle 12 until the apparatus
is in the blunting configuration with the blunt end of blunting
member 70 extending beyond the puncture tip at the puncture tip of
needle 12. This rolling motion allows the user to deploy the
blunting member without applying a pushing force directly in an
axial direction, i.e., in the direction in which the needle was
inserted. Thus, the threaded engagement of the blunting component
and the needle component provides a deployment means for the
apparatus. Further, since direct rearward axial pressure on the
extended blunting member will not cause the device to change from
the blunted configuration back to the insertion configuration, this
threaded embodiment can be described as providing a locking means
that is integral with the deployment means.
[0119] Another embodiment of a wing set comprising an oblique
motion deployment means in accordance with the present invention
will be understood with respect to FIGS. 12B and 12C. FIG. 12B
provides an exploded view of the winged needle apparatus which
comprises two moving parts, a needle component comprising a needle
cannula 12 mounted in a winged body 214". As seen in FIG. 12B,
driver 276" comprises a driver body 276a" and a third wing 278" for
convenient manipulation of the driver by the user. Driver 276"
comprises at the rearward portion thereof a fitting 86c that
defines an aperture 86 that communicates with the hollow interior
bore of blunting member 70. Fitting 86c has a slightly tapered
configuration for convenient insertion into the end of a convention
fluid flow device or tube through which biologic fluids may be
delivered to or withdrawn from the winged needle apparatus.
[0120] Winged body 214" defines at its rearward end a cam extension
80 that defines an internal bore 80a that communicates with the
internal bore of cannula 12. In addition, bore 80a is dimensioned
and configured to receive blunting member 70 and collet 76a in
which the blunting member is mounted therein. Cam extension 80
defines a generally spiral slot 84 bounded by cam surfaces 84a and
84b. It also defines a circumferential catch slot 132a that
communicates with slot 84 that is disposed radially about the axis
of winged body 214".
[0121] FIG. 12C depicts the driver 276" with the blunting member
removed to simplify the Figure. It can be seen that collet 76a
defines a passageway therethrough with a beveled opening to
facilitate the insertion of blunting member 70 therein. In the
perspective of FIG. 12C, it can also be seen that driver 276"
defines an inwardly-extending tooth 76b. Tooth 76b is configured to
be received within slot 84 on the cam extension 80 of winged body
214, preferably with end surfaces 76c and 76d positioned
sufficiently close to cam surfaces 84a and 84b so that driver 276"
does not move axially relative to winged body 214" without rotation
about the needle axis. In addition, tooth 76b has an axial width
that allows it to rotate circumferentially into catch slot
132a.
[0122] Cam extension 80 defines an entry notch 80b and an entry
slot 132b that communicates with cam slot 84. To assemble the
device, tooth 76b is aligned with entry notch 80b and blunting
member 70 is inserted into bore 80a until tooth 76b enters notch
80b. Then, the driver 276" is rotated so that tooth 76b travels
through entry slot 80c and into cam slot 84. In this initial
position, wing 78 is positioned close to wing 16a and the wing set
is in a sharpened configuration, in which the blunt tip of blunting
member 70 is withdrawn into the interior of needle cannula 12.
Preferably, the winged needle apparatus is configured so that third
wing 78 can be rotated to the 90-degree position between the haft
wings 16a and 18a without blunting the needle cannula. The user can
then insert the needle cannula into a vein in the usual manner,
e.g., by bending wings 16a, 18a and 78 together as a haft to
manipulate the needle for insertion into the patient's vein. Once
the needle is in its proper position, the wings are released and
allowed to lie flat and can be taped to the patient's skin. Wing 78
is then rotated further and the forward motion of tooth 76b in cam
slot 84 moves the blunting member forward so that the blunt tip of
the blunting member protrudes beyond the tip of the needle cannula.
The needle device is thus moved from the sharpened configuration to
the blunted configuration. (Reverse rotation of wing 78 can move
the device back to the sharpened configuration by moving blunting
member 70 rearward.) Upon full rotation, tooth 76b is aligned with
catch slot 132a. The user may then counter-rotate wing 78 into
contact with wing 76a while keeping driver 276" in the forward
position, which action moves tooth 76b into catch slot 132a and
away from cam slot 84. In this position, the blunting component is
constrained against axial motion (i.e., is locked) relative to the
needle member due to the configuration of catch slot 132a. The user
may then tape the wing set to the patient's skin, securing wing 78
in the forward position, thus assuring that the device remains in
the blunted configuration.
[0123] It will be understood that a tooth and cam slot engagement
between the blunting member and needle member as shown in FIG. 12B
may provide that the tooth be formed on the needle member and the
cam slot on the blunting member. Such an embodiment is indicated in
the exploded view of FIG. 12D, in which tooth 76" is carried on
winged body 214" and driver 276" forms the entry slot, cam slot and
locking slot on the interior surface of body 276a" as suggested in
dotted outline.
[0124] Winged body 214" defines a bore extending therethrough and,
at the forward end thereof, a beveled entrance to the bore
configured similar to first end 22a (FIG. 2) of body 22 to
facilitate the insertion of the rearward end of needle cannula 12
therein. A guide member 300 is inserted into the bore of winged
body 214". Guide member 300 defines a passage therethrough, the
forward end of which is aligned with, and is preferably not larger
than, the bore through the needle cannula 12. The rearward end of
the internal passage in guide member 300 diverges outwardly to form
a funnel-like configuration so that when the blunting member is
inserted into winged body 214", it can engage the divergent
entrance of guide member 300 and be guided via the guide member
passage into the needle bore. Guide member 300 also serves to
provide a seal between the blunting member 70 and winged body 214".
Optionally, guide member 300 can be formed integrally with winged
body 214".
[0125] Optionally, locking means may be incorporated into any of
the embodiments of the present invention to hold the blunting
component in the blunted configuration.
[0126] In addition to the locking means previously described, FIGS.
12E and 12F illustrate further embodiments of locking means for use
with wing set embodiments of the invention.
[0127] One such locking means embodiment comprising a tooth or
detent on one member and a ramp on the other will be understood
with reference to FIG. 12E, which shows a cam extension member 80'
on winged body 314'. Cam extension 80' is configured generally like
cam extension 80 of winged body 214 of FIG. 12B, with the following
exceptions. At the forward end of axially-extending slot 84' (FIG.
12E) there is formed an axially-extending ramp 302 which is
configured so that the distance from the axial center of winged
body 314' to the surface of the ramp increases as sensed moving
forward towards the tip of the needle. In this way, the detent on a
driver (such as tooth 76b on driver 276", FIG. 12C) not only moves
forward in slot 84' as the blunting member is advanced, it also
rides up ramp 302 in the forward end of the slot towards catch slot
132a. The detent is biased so that when it advances past ramp 302
it will fall into catch slot 132a. Ramp 302 forms a shoulder that
faces catch slot 132a so that once the detent has fallen into the
catch slot 132a, rearward motion will cause it to bear against the
shoulder of ramp 302 and the detent will prevent further rearward
motion to the sharpened configuration. Ramp 302 thus provides a
locking mechanism that tends to keep the blunting member in the
forward, i.e., blunted, configuration, by inhibiting rearward
movement of the blunting component. Optionally, the detent may be
formed on a portion of the annular carrier member that is slotted
on either side of the detent. The detent is thus mounted on a
resilient leaf spring to facilitate its riding up ramp 302 and then
falling in the catch slot 132a.
[0128] In addition to ramp 302, FIG. 12E illustrates another
locking means which, although illustrated for use in conjunction
with ramp 302, can be used independently thereof. This second
locking means is provided by a pinch region 304 of slot 84' in
which the width 306 of slot 84' gradually narrows. Accordingly, the
tooth or detent of a driver member situated in slot 84' moves
forward in slot 84' and reaches pinch region 304, the cam surfaces
84a' and 84b' bear against the lateral edges of the detent.
Preferably, one or both of the tooth and the material forming cam
surfaces 84a' and 84b' comprise resilient material so that the
pressure of cam surfaces 84a' and 84b' against the sides of the
detent does not prevent forward movement of the driver but rather
causes elastic deformation of the tooth and/or the cam surfaces.
Pinch region 304 opens abruptly to shoulders that straddle slot
84'. When the detent emerges from slot 84', one or both of the
detent and the material forming cam surfaces 84a' and 84b' relaxes.
As a result, the detent is not sized for entry into slot 84' from
the forward end thereof. The narrowing of slot 84' in pinch region
304 and the resiliency of one or both of the detent and the cam
surfaces that define the slot thus provide a locking means that
inhibits the blunting member from moving rearward directly into
slot 84' and toward the blunted configuration.
[0129] Optionally, a winged body comprising either or both of the
locking means described above with reference to FIG. 12E may
comprise a reset feature. In the illustrated embodiment, the reset
feature is provided by return ramp 308. While the locking means,
e.g., one or both of ramp 302 and pinch region 304, inhibits the
detent on the driver from directly reentering slot 84' once it has
reached catch slot 132a, return ramp 308 is configured so that it
is accessible to the detent from catch slot 132a. The user can then
draw the driver backwards, moving the device from the blunted
configuration to a sharpened configuration, until the detent falls
from return ramp 308 into slot 132b. Return ramp 308 rises from
catch slot 132a to form a shoulder that faces slot 132b so that the
detent is inhibited from moving from slot 132b to catch slot 132a
via return ramp 308. Once the detent has returned to slot 132b, the
driver must be rotated once again to advance the detent into slot
84' and forward to the locking means.
[0130] Another ramp and detent embodiment of a locking means for
use in a wing set embodiment is illustrated in FIG. 12F. In this
Figure, winged body 314" carries a wedge 310 that defines a ramp
312 and a forward-facing shoulder. Third wing 378 on driver 376
carries a tooth or detent 316. The wedge 310 and detent 316 are
dimensioned and configured so that when driver 376 is rotated to
advance the blunting member thereon into the blunting configuration
(as described, e.g., in regard to the device shown in FIG. 12B),
detent 316 rides up on ram surface 312 and then falls in front of
the shoulder formed by wedge 310. As a result, driver 376 is
prevented from moving rearward should third wing 378 be
counter-rotated.
[0131] A variety of other deployment means may be used to move the
apparatus of this invention from the blunted configuration to the
insertion configuration. For example, the deployment means may
comprise a contrary motion linkage that moves the blunting member
forward relative to the needle cannula in response to a rearward
relative motion imposed on the deployment means by the user. The
contrary motion linkage may take the form of a lever in which the
first end of the lever is connected to one of the needle component
and the blunting component, the fulcrum is connected to the other
of these components and the user manipulates the second end of the
lever. With the fulcrum so positioned, rearward motion of the
user's second end of the lever will produce forward motion of the
first end of the lever and of the component connected thereto. Such
an embodiment is illustrated schematically in FIG. 13A, in which
the drive member comprises a lever 176 having a first end 176a
pivotably connected via an access aperture in winged body 14b to a
shuttle 54f of a blunting component that comprises blunting member
70, and a second end 176b for manipulation by the user. The fulcrum
176c is mounted on winged body 14b between first end 176a and
second end 176b, so that when the user pulls second end 176b
rearward (to the left, as sensed in FIG. 13A), first end 176a moves
generally forward, thus moving the apparatus from the insertion
configuration to the blunted configuration.
[0132] In an alternative contrary motion mechanism shown in FIG.
13B, the deployment means may comprise a tension line 276 that is
attached to the blunting component shuttle 54g and which extends
forwardly in a conduit within body 14c to an access aperture in the
conduit, at which point it may be diverted backwards. When the user
pulls on tension line 276 in a backwards direction, the line will
pull the blunting component forwards. Optionally, tension line 276
may be connected to a partially coiled section of tubing coupled to
the apparatus, and the blunting component may be deployed by
straightening the partially coiled segment of tubing.
[0133] According to still another embodiment of the invention shown
in FIG. 13C, the deployment means may comprise a drive member in
the form of a roller 376 having an axle 376a mounted on one of the
needle component and the blunting component, e.g., on the winged
body 14d. Axle 376a, which defines the axis of rotation of roller
376, is disposed transversely, preferably at right angles, relative
to the longitudinal axis of the needle cannula (not shown) in the
apparatus. The cylindrical outer surface of roller 376 engages
shuttle 54h via an access aperture in winged body 14d and when the
user rolls the exposed portion of roller 376 in a backward
direction, roller 376 can slide the blunting component in a forward
direction. Optionally, a haft member corresponding to wings 18 can
be mounted on axle 376a. In such an embodiment, the wings (not
shown) may be displaceable so that they can be folded together
(upward, as sensed in FIG. 13C) about a pivot point on the axis of
axle 376a to facilitate insertion of the needle (not shown). Such
displacement of the wings would not effect rotation of roller 376.
To deploy the blunting component, the wings have to be turned about
an axis that is substantially perpendicular to the longitudinal
axis of the needle, to rotate the axle 376a on which roller 376 is
provided.
[0134] FIGS. 14A and 14B illustrate still another embodiment of the
present invention, in which the deployment means comprises a stored
energy device and a release mechanism. While such deployment means
may be employed with any needle apparatus, it is illustrated in
FIGS. 14A and 14B with respect to a apparatus 10g. Apparatus 10g
comprises a needle 12 mounted in a winged body 14f that provides a
hub for needle 12. The needle component, comprising winged body 14f
and needle 12, is disposed in tandem relation with the blunting
component, which comprises the blunting member 70 mounted on
blunting component hub 54k. Hub 54k defines a proximal aperture
(not numbered) to which a connector tube 72 may be secured.
Blunting component hub 54k comprises a collet portion 54j to which
one end of an extended spring 76b is secured. The other end of
spring 76b is secured to the proximal surface 14g of winged body
14f. Accordingly, when apparatus 10g is disposed in the initial
insertion configuration, spring 76b imposes a bias toward pulling
collet portion 54jcloser to winged body 14f, to advance the
blunting member and moving apparatus 10g from the insertion
configuration to the blunted configuration. To maintain apparatus
10g in the initial insertion configuration until venipuncture is
accomplished, winged body 14f carries a release mechanism 76c.
Release mechanism 76c comprises a detent member 76d that is
pivotably mounted on winged body 14f, as best seen in FIG. 14B.
Detent member 76d protrudes through an access aperture in winged
body 14f and rests in a notch in blunting component hub 54k (not
shown), where it prevents the blunting component from moving
forward under the impetus of spring 76b. After venipuncture, the
user depresses touch pad 76e, thus causing detent 76d to rise
upward, withdrawing from the notch in the blunting component hub,
as indicated by the movement arrows (not numbered). The blunting
component is then free to move forwardly under the impetus of
spring 76b.
[0135] The appended claims are intended to cover any and all of
such modifications which fall within the spirit and scope of the
invention and are not limited to the embodiments expressly
described above.
* * * * *