US20040254499A1 - Holder for blood collection needle with blunting mechanism - Google Patents
Holder for blood collection needle with blunting mechanism Download PDFInfo
- Publication number
- US20040254499A1 US20040254499A1 US10/842,278 US84227804A US2004254499A1 US 20040254499 A1 US20040254499 A1 US 20040254499A1 US 84227804 A US84227804 A US 84227804A US 2004254499 A1 US2004254499 A1 US 2004254499A1
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- United States
- Prior art keywords
- needle
- actuator
- blunting member
- shuttle
- shell
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/15003—Source of blood for venous or arterial blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
- A61B5/150404—Specific design of proximal end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
- A61B5/150488—Details of construction of shaft
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61B5/154—Devices using pre-evacuated means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/15132—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
Definitions
- the present invention pertains to self-blunting needle devices and, in particular, to holders for blood collection needles.
- Conventional blood collection systems are known in the art to comprise a holder, typically in the form of a generally cylindrical shell that holds a double-ended needle cannula.
- a holder typically in the form of a generally cylindrical shell that holds a double-ended needle cannula.
- One end of the needle cannula extends forward from the holder and is used for venipuncture (the “venipuncture needle”), while the other end (the “filling needle”) extends into the holder and is used to puncture the seal cap on a sample fluid collection tube (which, typically, is vacuum sealed).
- the device is used by unsheathing the venipuncture needle and effecting venipuncture and then inserting the sealed end of a collection tube into the holder and pushing the seal cap against the boot that covers the tip of the filling needle.
- the filling needle pierces the boot and the seal cap and blood is drawn into the collection tube. If additional samples are required, the first collection tube is removed and a second collection tube is pushed into the holder in its place. When the last tube is filled, the blood collection needle is withdrawn from the patient's vein.
- Prior art self-blunting blood collection needles have provided a deployable, locking, blunting member to protect the user against inadvertent needle sticks but required the user to engage in an extraneous manipulation of the sample tube in order to deploy the blunting member such as the insertion of the sample tube past a discernible “stop” point at which the collection tube is already fully engaged by the filling needle.
- a self blunting needle mechanism that does not require manipulation beyond that which is familiar to medical technicians with the use of conventional blood collection needles.
- the present invention relates to a needle holder apparatus comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein and for carrying thereon a needle cannula, an actuator movably disposed in the shell for engaging and moving a blunting member longitudinally within the shell and means for moving the actuator between a forward position and a retracted position in response to the insertion and withdrawal of a sample collection tube in the shell.
- the means for moving the actuator may comprise a transmitter device connected to the shell and being configured to move obliquely in the shell upon insertion of such sample collection tube into the shell. There may also be a linkage between the transmitter device and the actuator to convert the oblique motion of the transmitter device into rearward motion of the actuator when such sample tube is inserted into the apparatus.
- the apparatus may include a biasing member positioned and configured to urge the actuator toward the forward position.
- the linkage may comprise a cam and follower engagement between the actuator and the transmitter device.
- there may be a staggered cam and follower engagement between the actuator and the transmitter device.
- the transmitter device may be configured to contact such sample collection tube at a point between the connection to the shell and the linkage to the actuator.
- the transmitter device may extend forwardly in the shell from its point of attachment to the shell.
- the transmitter device may comprise at least two transmitter arms.
- either of the actuator and the transmitter device may comprise a cam surface.
- the apparatus may comprise a biasing member urging the actuator member toward the forward position.
- this invention may provide a needle holder apparatus comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein and for carrying thereon a needle cannula, an actuator movably disposed in the shell for engaging and moving a blunting member axially within the shell, a transmitter device connected to the shell and being configured to contact a sample collection tube which may be inserted into the shell and to move obliquely relative to the motion of the sample collection tube, and a positive motion cam engagement between the transmitter device and the actuator to convert the oblique motion of the transmitter device into axial motion of the actuator, to move the actuator axially in the shell in response to the oblique motion of the transmitter device, wherein the apparatus is biased to dispose the actuator in the forward position.
- the present invention also provides a blood collection needle comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein, a needle cannula carried on the shell, a blunting member disposed telescopically within the needle cannula for movement between a withdrawn position which disposes the needle in a sharpened configuration and a blunting position which disposes the needle in a blunted configuration, and a mechanism for moving the blunting member to the withdrawn position when a sample collection tube is inserted into the holder and for moving the blunting member to the blunting position when the sample collection tube is withdrawn from the shell.
- the mechanism may comprise an actuator movably disposed in the shell, the actuator being secured to the blunting member so that the blunting member can be moved between the blunting position and the withdrawn position by movement of the actuator, a movable transmitter device connected to the shell and being configured for contact with a sample collection tube which may be inserted into the shell and to move obliquely relative to the motion of a sample collection tube in the shell, a biasing member configured to urge the blunting member to the blunting position upon withdrawal of a sample collection tube from the shell, and a linkage between the transmitter device and the actuator to convert the oblique motion of the transmitter device into forward and rearward motion of the actuator, to move the blunting member from the blunting position to the withdrawn position.
- FIG. 1A is a cross-sectional view of a needle hub for holding a needle cannula in a blood collection device
- FIG. 1B is a perspective view of a blunting member shuttle intended for use with the needle hub of FIG. 1A;
- FIG. 1C is a view of the shuttle of FIG. 1B taken along line 1 C- 1 C;
- FIG. 1D is a cross-sectional view of a safety needle assembly comprising the hub and shuttle of FIGS. 1A and 1B with a needle cannula and blunting cannula secured therein;
- FIG. 2 is a cross-sectional view of a collection tube holder and a blunting mechanism for use with the present invention
- FIG. 3 is a cross-sectional view of a passive blood collection needle in accordance with a particular embodiment of the present invention, comprising the holder and blunting mechanism of FIG. 2 and the needle assembly of FIG. 1D;
- FIGS. 4A and 4B are views similar to FIG. 3 of the device of FIG. 3 in the insertion and blunted configurations, respectively;
- FIG. 5A is a schematic plan view of a rotator element for use in a blunting mechanism in accordance with another embodiment of the present invention.
- FIG. 5B is a cross-sectional view of the element of FIG. 5A taken along line 5 B- 5 B;
- FIG. 5C is a cross-sectional view of the element of FIG. 5A taken along line 5 C- 5 C;
- FIG. 6 is an exploded perspective view of a transmitter element and an actuator element for use with the rotator element of FIG. 5A in a blunting mechanism in accordance with the present invention
- FIG. 7A is a perspective view of a sample tube holder for use with the elements shown in FIGS. 5A and 6;
- FIG. 7B is a view of the holder of FIG. 7A taken along line 7 B- 7 B;
- FIGS. 8A and 8B are schematic cross-sectional views of a passive blood collection needle comprising the elements shown in FIGS. 5A, 6 and 7 A, in the blunted and insertion configurations, respectively, with the needle assembly omitted to clarify the drawing;
- FIG. 8C is a view similar to FIGS. 8A and 8B of the blunting mechanism as it will be configured upon the initial installation of a locked needle assembly prior to insertion of a sample collection tube;
- FIG. 8D is an elevation view of a transmitter device of a blunting mechanism according to yet another embodiment of this invention.
- FIG. 8E is an elevation view of the transmitter device of FIG. 8D together with a blood collection tube in a holder shell shown in cross section;
- FIG. 9A is a cross-sectional schematic view of a blunting mechanism in a needle holder in accordance with a first lever embodiment of the present invention.
- FIG. 9B is a plan view of ring lever 210 of FIG. 9A;
- FIG. 9C is a perspective view of the ring lever 210 of FIG. 9B;
- FIG. 9D is a perspective view of an alternative embodiment of a lever-type mechanism similar to the one of FIGS. 9A-9C;
- FIGS. 10A and 10B are schematic cross-sectional views of a blood collection needle in accordance with still another embodiment of the present invention.
- FIG. 11 is a schematic cross-sectional view of a blood collection needle comprising a needle holder in accordance with another lever embodiment of the present invention.
- FIGS. 12A and 12B are cross-sectional views of a holder for a blood collection needle in accordance with another embodiment of the invention.
- FIG. 12C is an end view of the embodiment of FIGS. 12A and 12B;
- FIG. 13A is a cross-sectional view of a holder according to yet another embodiment of the invention.
- FIG. 13B is a partial perspective view of an arm extension and actuator of FIG. 13A shown in an initial, blunted configuration without a sample tube in the device;
- FIG. 13C is a view of the structures of FIG. 13B locked in a blunted position after the withdrawal of a sample tube from the device;
- FIG. 14A is a schematic view of a needle holder in accordance with still another embodiment of the invention.
- FIG. 14B is a view of the holder of FIG. 14A taken generally along the line indicated at B-B in FIG. 14A;
- FIG. 14C is a perspective view of the transmitter arms and actuator of the mechanism shown in FIG. 14A.
- FIG. 15 is a schematic view of the holder of FIG. 14A with a needle, blunting member and sample collection tube therein, and with the device in the sharpened configuration.
- the present invention relates to a holder for a blood collection needle having a movable blunting member.
- the holder has a mechanism for engaging and deploying a blunting member upon withdrawal of a blood collection tube from the tube holder, to blunt the venipuncture needle and so safeguard the patient and the technician from inadvertent needle sticks.
- the mechanism may function to retract the blunting member to re-sharpen the venipuncture needle when a subsequent collection tube is inserted into the holder.
- the mechanism is responsive to the insertion and withdrawal of the blood collection tube to retract and deploy the blunting member accordingly.
- One basic and novel feature of the present invention is that the mechanism allows the user to blunt and, optionally, re-sharpen the venipuncture needle without requiring manipulation of the collection tube or the needle holder other than that normally performed for conventional blood collection needle systems, as described above. For example, it is not necessary to manipulate the blunting member in any manner other than by the insertion or withdrawal of the sample tube to engage or disengage the filling needle.
- Four types of mechanisms are disclosed: a rack and pinion mechanism, a cylindrical cam mechanism, a lever mechanism, and a pliable, resilient strap mechanism.
- the mechanism in each of these devices comprises an actuator member which engages the blunting member for movement in the holder between a forward or deployed position which places the device in a blunted configuration and a rearward or withdrawn position which places the device in a sharpened configuration.
- the mechanism also comprises a transmitter which is moved by a sample collection tube as the tube is inserted into or removed from the device.
- the mechanism is designed to convert motion imposed on the transmitter device upon insertion of a sample collection tube as it is inserted into the device into a rearward motion of the actuator and consequently into withdrawal of a blunting member, if one is secured to the actuator.
- the transmitter moves forward or rearward in the device with the sample collection tube and the mechanism includes a reversing member for imparting a motion on the actuator in a direction opposite to that of the transmitter device.
- the mechanism includes a cam and follower engagement between the transmitter and the actuator.
- the transmitter movers obliquely relative to the sample collection tube.
- an optional safety needle assembly comprising a needle cannula mounted in a needle hub combined with a blunting member mounted in a shuttle.
- the blunting member is designed to be received within the needle cannula and the shuttle is configured to be received within the needle hub.
- a locking mechanism comprising a detent resiliently mounted on the shuttle is configured to releasably engage locking apertures in the needle hub. The locking mechanism and the blunting mechanism may be used together by configuring the blunting mechanisms to release the detent from the locking apertures when the needle assembly is installed in the needle holder.
- FIG. 1A shows a needle hub 10 that comprises a generally cylindrical body 12 having a longitudinal axis A, a first end 12 a and a second end 12 b .
- Needle hub 10 also comprises a circumferential locking flange 18 and at least one locking spline 20 (FIG. 1D) by which needle hub 10 can be secured in a needle holder, as described below.
- the interior of needle hub 10 comprises a hub passageway 14 extending therethrough.
- the shuttle portion 14 b of passageway 14 (generally between second end 12 b and flange 18 ) is dimensioned and configured to slidably receive a shuttle (FIG. 1B) therein.
- Body 12 defines two locking notches 16 a and 16 b and a channel 16 c formed together as an aperture through the cylindrical wall of body 12 .
- the mounting portion 14 a of passageway 14 (generally between flange 18 and first end 12 a ) is dimensioned and configured to receive a needle cannula in the forward end thereof.
- the funnel-like insertion regions 14 c and 14 d at the ends of mounting portion 14 a of passageway 14 converge from the shuttle portion 14 b and the first end of hub 10 , respectively, and facilitate the insertion therein of a blunting member and a needle cannula in assembly steps described below.
- FIG. 1B shows a blunting member shuttle 24 which has a generally cylindrical body that is dimensioned and configured to be slidably received within the shuttle portion 14 b of passageway 14 of hub 10 , as will be described below.
- Shuttle 24 defines a central axial passageway 24 a therethrough within which may be mounted a blunting member.
- Shuttle 24 comprises a detent 28 that is mounted on the end of a resilient arm 24 b .
- Resilient arm 24 b suspends detent 28 at a stand-off from the remainder of the shuttle body, indicated as stand-off S in the end view of FIG. 1C.
- stand-off S in the end view of FIG. 1C.
- detent 28 has a protruding surface 28 a that is disposed obliquely relative to the cylindrical periphery of shuttle 24 . Therefore, a force applied upon surface 28 a substantially along a tangent to the shuttle body (or parallel to such a tangent) can drive detent 28 in a radial direction (towards passageway 24 a ), narrowing stand-off S by flexing arm 24 b.
- Shuttle 24 comprises shuttle flanges 32 that permit shuttle 24 to engage another structure, as described below.
- Shuttle 24 also defines a boot barb 34 on which a self-sealing boot for sealing the sharpened insertion end 26 b of blunting member cannula 26 may be anchored, as is well-known in the art.
- the shuttle portion 14 b of passageway 14 is dimensioned and configured to slidably receive shuttle 24 therein.
- a portion of second cannula 26 extends forward from shuttle 24 through passageway 14 and into needle cannula 22 , within which it is telescopically disposed and wherein it terminates at a first, blunt end.
- the forward extending portion of second cannula 26 is referred to herein as the blunting member 26 a .
- Second cannula 26 and needle cannula 22 cooperate to form a fluid flow passageway that extends through both of them.
- the blunting member 26 a and the needle cannula 22 are disposed telescopically one within the other without obstructing flow through the needle passageway.
- insertion region 14 c converges to a diameter that is smaller than the internal diameter of needle cannula 22 and it is aligned therewith so that it provides a stop for the insertion of needle cannula 22 into body 12 as well as guiding blunting member 26 a of blunting member cannula 26 into the proximal end of needle cannula 22 .
- Second cannula 26 also extends rearward from shuttle 24 , terminating at a second, sharp end (sometimes referred to herein as a “filling needle”) for puncturing the seal on a collection tube and for providing a conduit to establish fluid flow communication between the collection tube and needle cannula 22 , as will be described below. Second cannula 26 is securely mounted within shuttle 24 so that it moves with shuttle 24 .
- Detent 28 on shuttle 24 is dimensioned and configured to protrude through, and to be secured within, locking notches 16 b and 16 a , to secure the relative positions of shuttle 24 and needle hub 10 .
- FIG. 1D shows needle assembly 30 in an insertion configuration (sometimes referred to herein as the “sharp configuration”), in which shuttle 24 is in a retracted position in hub 10 . As shown, assembly 30 is locked in the sharp configuration by the engagement of detent 28 in rear locking notch 16 b . Pressing detent 28 into passageway 14 disengages the detent from notch 16 b so that shuttle 24 may be advanced within passageway 14 .
- Detent 28 can slide along channel 16 c until it engages forward locking notch 16 a , thus securing shuttle 24 in an advanced or extended position within needle hub 10 , resulting in a blunted configuration in which the blunt end of blunting member 26 a protrudes beyond the sharp tip of needle cannula 22 (as indicated in dotted outline), blunting the needle assembly.
- FIG. 2 One embodiment of a needle assembly holder in accordance with the present invention is shown in FIG. 2.
- Holder 36 comprises a cylindrical shell 38 that defines a needle aperture 40 at its forward end.
- Aperture 40 is dimensioned and configured to receive a needle assembly comprising a needle cannula and a blunting member that are telescopically and movably disposed one within the other, such as needle assembly 30 (FIG. 1D).
- An annular flange 40 a protrudes into aperture 40 and defines notches (not shown) that are sized to allow spline 20 and detent 28 to pass therethrough as needle hub 10 is inserted into aperture 40 .
- Flange 40 a is dimensioned and configured to engage hub flange 18 of needle assembly 30 (FIG.
- Flange 40 a may be configured to be received in a friction fit between flanges 18 and spline 20 (FIG. 1D) when hub 10 is inserted into aperture 40 as far as flanges 18 and 40 a will permit and then rotated to move spline 20 out of alignment with the notch in flange 40 a .
- a stop lug (not shown) is positioned in aperture 40 to engage spline 20 upon such rotation and thus limit the rotation to a suitable turn, e.g., 45 degrees. Needle assembly 30 may thus be mounted in holder shell 38 .
- Shell 38 contains a mechanism 42 .
- Mechanism 42 comprises a transmitting sleeve 44 comprising racks 46 which, in the illustrated embodiment, comprise toothed splines.
- Mechanism 42 further comprises pinions 48 which, in the illustrated embodiment, comprise toothed gears, and an actuator ferrule 50 comprising racks 52 .
- Mechanism 42 also includes a spring 54 .
- Pinions 48 engage racks 46 and 52 and thus serve as a link between them.
- the link member and its manner of connection to the transmitter, to the shell and to the actuator serve as means for moving the actuator in the holder in an opposite direction from that of the transmitter.
- Transmitting sleeve 44 is slidably disposed in the interior of shell 38 and racks 46 , which are preferably diametrically opposed from one another in shell 38 , are slidably disposed in axial grooves in the interior wall of shell 38 .
- Transmitting sleeve 44 has at its coupling end 44 a an access aperture 44 b .
- Coupling end 44 a is dimensioned and configured to engage the filling end of a conventional collection tube and aperture 44 b permits the sharp end of a filling needle such as the end of cannula 26 (FIG. 1D) to protrude therethrough into a collection tube.
- FIG. 2 shows mechanism 42 in a deployed configuration, i.e., a configuration in which actuator ferrule 50 is positioned forward in shell 38 , where it can be retracted or withdrawn (moved downward, as sensed in the Figure), as will be described herein. (This position is referred to as “deployed”.
- Actuator ferrule 50 is disposed within shell 38 and comprises a pair of racks 52 that engage pinions 48 .
- ferrule 50 The interior of ferrule 50 is dimensioned and configured to permit the insertion and rotation of needle assembly 30 therein as is necessary to mount needle assembly 30 in shell 38 , without depressing detent 28 (FIG. 1D).
- ferrule 50 may have an L-shaped groove on its interior surface, with detent 28 moving in an axial or longitudinal leg of the groove as needle assembly 30 is inserted into shell 38 . Detent 28 may then move in a circumferential leg of the groove when needle assembly 30 is rotated in aperture 40 .
- ferrule 50 may have an internal lug or fillet positioned to engage detent 28 only after needle assembly 30 is mounted in shell 38 and ferrule 50 is moved rearward.
- the shuttle flanges 32 on shuttle 24 are eccentrically configured about the longitudinal axis of the device, and actuator ferrule 50 forms a cap aperture in cap 50 a that is configured to align with flanges 32 and permit them to pass therethrough upon initial insertion of needle assembly 30 into shell 38 .
- Spring 54 is configured so that, when the shuttle flanges 32 pass through the aperture in cap 50 a , they engage spring 54 .
- Mechanism 42 is dimensioned and configured so when transmitting sleeve 44 is moved forward within shell 38 (e.g., as a result of the insertion of a collection tube), actuator ferrule 50 moves in the reverse direction, away from forward end 36 a , under the operation of pinions 48 .
- Mechanism 42 thus moves from the pre-filling configuration shown in FIG. 3 to a filling configuration. Such movement also imposes further tension or compressive force on spring 54 .
- FIG. 3 The fully assembled blood collection needle 55 is shown in FIG. 3 with needle assembly 30 mounted in aperture 40 (FIG. 2).
- the needle cannula 22 is in fixed relation to the holder because of the engagement of annular flange 40 a (FIG. 2) with flange 18 (FIG. 1D) and spline 20 (FIG. 1D, not seen in FIG. 3).
- Collection needle 55 is in an initial, pre-filling configuration in which needle assembly 30 is in a sharpened configuration even though actuator ferrule 50 is in a deployed position, because shuttle 24 on blunting member 26 a has not yet engaged actuator ferrule 50 .
- shuttle flanges 32 of needle assembly 30 protrude beyond end cap 50 a (FIG. 2) of ferrule 50 and compress spring 54 .
- Shuttle 24 resists being moved by spring 54 forward into hub 10 because detent 28 is locked in notch 16 b (FIG. 1A), leaving needle assembly 30 locked in the sharp configuration, ready for venipuncture.
- a technician will typically install needle assembly 30 in holder 36 as shown in FIG. 3, and then remove from needle cannula 22 a protective sheath (not shown) and insert needle cannula 22 into a patient's vein. Then, the technician will take a conventional collection tube 56 a (FIG. 4A) and insert the capped end thereof into the open end 38 a of shell 38 with sufficient force to assure that filling needle 26 b punctures the seal cap 56 b on the collection tube, thus establishing flow communication between the collection tube and the needle assembly. This action will impose sufficient force on coupling end 44 a to drive transmitting sleeve 44 forward in needle holder 36 (upward as sensed in FIG.
- mechanism 42 will transfer the forward motion of transmitting sleeve 44 into rearward movement of actuator ferrule 50 indicated by arrows 56 (downward, as sensed in FIG. 3), under the operation of pinions 48 .
- mechanism 42 causes actuator ferrule 50 to move in a direction opposite from that of transmitting sleeve 44 .
- the interior of ferrule 50 is configured so that such rearward movement causes it to depress detent 28 and thus unlock the needle assembly.
- Shuttle flanges 32 then bear on end cap 50 a under the force of spring 54 . This motion will conclude with mechanism 42 in the retracted configuration shown in FIG.
- needle assembly 30 in which actuator ferrule 50 and shuttle 24 are in their retracted positions due to the advancement of transmitting sleeve 44 , leaving needle assembly 30 in the sharpened configuration.
- actuator ferrule 50 The additional forward movement of actuator ferrule 50 relative to shuttle 24 allows the internal fillet or groove that previously unlocked the needle assembly to disengage from the locking detent. Accordingly, detent 28 can engage locking notch 16 a to lock needle assembly 30 in the blunted configuration.
- the additional forward movement of ferrule 50 also causes end cap 50 a to disengage from shuttle flanges 32 .
- Mechanism 42 comes to rest in the deployed configuration shown in FIG. 4B. Subsequent insertion of another collection tube will cause the actuator ferrule 50 to move rearward again, unlocking shuttle 24 and then engaging shuttle flanges 32 to return to the sharpened configuration shown in FIG. 4A, and removal of the tube thereafter will once again return the device to the blunted configuration of FIG. 4B.
- mechanism 42 serves to move actuator ferrule 50 and the blunting member 26 a in a direction contrary to that of the sample tube and transmitting sleeve 44 in the holder shell. Such motion is illustrated as changes between the configurations of FIGS. 4A and 4B.
- actuator ferrule 50 may carry locking flanges disposed about the central aperture of end cap 50 a (FIG. 2). Such locking flanges may be configured to engage shuttle flanges 32 (FIG. 1D) when the first insertion of a blood collection tube moves actuator ferrule 50 rearward from the initial configuration (FIG. 3) to the filling configuration shown in FIG. 4A.
- a mechanism in accordance with the present invention may incorporate a cam and follower arrangement instead of a rack and pinion arrangement.
- a rotating cylindrical cam (referred to herein as a “rotator”) will be disposed within the cylindrical body of the needle holder carrying the self-blunting needle assembly.
- An actuator structure (or “inner sleeve”) that engages the blunting member will follow the cam surface of the rotator.
- the actuator follows by imposing a corresponding axial motion on the blunting member in accordance with the direction of rotation of the rotator.
- the device is configured so that the forward insertion of a sample tube into the needle holder rotates the rotator in a direction that causes the actuator to retract (rearward) within the needle holder.
- the rotating cam embodiment of the present invention like the rack and pinion embodiment, creates contrary motion between the blunting member and the sample tube inserted into the holder with each insertion and withdrawal of a tube, except for the first time a collection tube is inserted into the holder.
- Such a device can employ the safety needle assembly 30 of FIG. 1B, as described below.
- FIGS. 5A, 5B and 5 C provide related views of a cylindrical cam or “rotator” 100 for use in one embodiment of the present invention.
- rotator 100 is seen to have a round periphery, thus allowing for coaxial rotation within a cylindrical needle holder.
- Rotator 100 has three principal concentric annular segments: at least one following surface 102 , at least one driving surface 104 and a central collet 106 .
- Following surfaces 102 are disposed in the circumferential, outermost annular segment of rotator 100 , which includes a flat upper surface 102 a and a flat lower surface 102 b .
- Driving surfaces 104 are concentrically contiguous with following surfaces 102 .
- the next annular segment of rotator 100 is collet 106 , which is physically connected to surfaces 102 and 104 by a bridge 108 .
- Bridge 108 spans a region between collet 106 and driving surfaces 104 that is occupied principally by a curvate gap 110 .
- the interior region 112 of collet 106 defines a recess 114 within which is disposed an unlocking fillet 114 a .
- Fillet 114 a is better viewed in FIG. 5B, which also shows that the following surfaces 102 occupy a first annular region R 1 and driving surfaces 104 occupy the contiguous annular region R 2 .
- rotator 100 can be disposed within the generally cylindrical shell 138 of a needle holder, rotatably resting on the bottom shoulder 138 a of shell 138 . So disposed, the impingement of an axial force as indicated, e.g., by arrow 152 a , on following surface 102 will cause rotator 100 to rotate in the direction of arrow 152 b . If the structure imposing the force at arrow 152 a is not permitted rotational movement as it bears on surface 102 , it will move downward (axially) as rotator 100 rotates.
- driving surfaces 104 slope in a helical direction opposite from that of following surfaces 102 , a structure that is slidably disposed on surface 104 and that is constrained against rotation will move upward on the contrary incline of driving surface 104 as the structure on surface 102 moves downward, as will be discussed further below.
- Transmitter 120 has a generally cylindrical configuration dimensioned to have the same outer diameter as rotator 100 so that the two can fit snugly in the same cylindrical needle holder shell. However, transmitter 120 also comprises guiding means for engaging the interior surface of the shell so that transmitter 120 will be inhibited against free rotational motion within the shell. Preferably, it will be constrained for axial motion within the shell. In the embodiment of FIG.
- the guiding means of transmitter 120 comprises a pair of peripheral guiding fillets 122 that are dimensioned and configured to be slidably received within axially-extending grooves in the interior wall of the shell within which transmitter 120 is disposed. With the fillets 122 disposed in such grooves, transmitter 120 will be able to move axially, i.e., longitudinally, within the holder shell, but will not be able to rotate therein.
- Transmitter 120 comprises a pair of driving surfaces 124 that are dimensioned and configured to engage following surfaces 102 of rotator 100 in annular region R 1 , within which they define a cylindrical receiving region C.
- FIG. 7A provides a perspective view of a sample tube holder that may house a mechanism comprising the rotator 100 , transmitter 120 and actuator 130 of FIGS. 5A, 5B, 5 C and FIG. 6.
- the holder comprises a shell 138 having a longitudinal axis A and a shoulder 138 a at its forward end.
- Shell 138 defines a pair of internally, axially disposed grooves 122 a , shown in dotted outline.
- FIG. 7B provides an end view of shell 138 , showing aperture 138 b which is dimensioned and configured to receive safety needle assembly 30 of FIG. 1D.
- Aperture 138 b is substantially circumscribed by a flange 138 c that is dimensioned and configured to permit the blunting component and rearward portion of the needle hub therein, but to engage hub flanges 18 (FIG. 1D), leaving the first end 12 a of needle hub 12 extending forward from shoulder 138 a .
- Notch 138 e is configured to receive a locking spline 20 (FIG. 1D)
- notch 138 f is dimensioned and configured to allow the detent 28 (FIGS. 1C and 1D) to pass through aperture 138 b to avoid unlocking the needle assembly as it is first being inserted into shell 138 .
- the needle assembly After insertion of the needle assembly into the aperture, the needle assembly is rotated so that the locking spline and flanges 18 engage flange 138 c . Also seen in FIG. 7B are two posts 138 g that extend axially from shoulder 138 a towards the rearward end of shell 138 .
- FIGS. 8A and 8B are cross-sectional schematic drawings that indicate the relative positions of the transmitter 120 , rotator 100 and actuator 130 in two different configurations within shell 138 .
- FIG. 8A depicts the holder mechanism in the deployed configuration.
- rotator 100 is rotatably situated within shell 138 and, because it is resting on shoulder 138 a , it is constrained against forward axial movement.
- the transmitter 120 is disposed in shell 138 so that the lower (as sensed in FIG. 8A) portions of its helical driving surfaces 124 engage the upper portions of the following surfaces 102 of rotator 100 .
- Transmitter 120 carries fillets 122 that engage grooves 122 a in shell 138 and thus permit axial sliding motion of transmitter 120 in shell 138 but prevent rotational motion.
- Actuator 130 is disposed within the outermost annular region of rotator 100 , with following surfaces 136 engaging driving surfaces 104 .
- An internal post 138 g extending from shell 138 through gap 110 (FIG. 5B) engages lug 139 to prevent actuator 130 from rotating within shell 138 .
- a spring 154 is disposed axially between transmitter 120 and actuator 130 .
- transmitter 120 moves downward, as indicated by arrow 156 a and the spiraled driving surface 124 bears upon the complementary following surface 102 of rotator 100 . Since transmitter 120 is con-strained against rotation, transmitter 120 acts as a driving cam follower and the downward motion of transmitter 120 causes rotator 100 to rotate within shell 138 . Such rotation of rotator 100 will cause driving surface 104 to impose a force upon following surface 136 of actuator 130 .
- rotator 100 serves as a linking member that moves actuator 130 in a direction opposite from that of transmitter 120 .
- FIG. 8B shows rotator 100 in a rotated position and actuator 130 in an elevated position relative to FIG. 8A.
- transmitter 120 and actuator 130 move towards each other from the pre-filling configuration of FIG. 8A to the filling configuration of FIG. 8B, they compress spring 154 .
- the friction fit of a collection tube in shell 138 is sufficient to withstand the tendency of spring 154 to decompress and move transmitter 120 (and the collection tube pressing against it) upward.
- spring 154 will drive transmitter 120 upward so that it remains in contact with the collection tube until it encounters a stop lug on the interior wall of shell 138 , e.g., lug 122 b in groove 122 a .
- the upward motion of transmitter 120 will tend to disengage driving surface 124 from following surface 120 .
- the needle assembly 30 is first inserted into the shell 138 in the sharpened configuration (shown in FIG. 1D) with mechanism 142 in the deployed configuration of FIG. 8A.
- detent 28 FIG. 1D
- notch 138 f FIG. 7B
- fillet 114 a FIG. 5B
- Locking spline 20 FIG. 1D
- hub flanges 18 FIG. 1D
- the needle assembly is rotated to engage flange 138 c between spline 20 and flanges 18 , thus locking the needle in the holder.
- This rotation disposes detent 28 beside fillet 114 a .
- the shuttle flanges 32 bear against locking tabs 134 a of actuator 130 , pushing actuator 130 upward (as sensed in FIG. 8A) and lifting it off rotator 100 to the position shown in FIG. 8C.
- the rotation of needle assembly 30 that engages flange 138 c also positions shuttle flanges 32 (FIG. 1B, 1D) between locking tabs 134 a and 134 b .
- Transmitter 120 and rotator 100 are in a deployed configuration, but actuator 130 is retracted and the needle assembly is sharp.
- the transmitter may be dimensioned and configured to engage the sample collection tube.
- a transmitter 120 ′ shown in FIG. 8D has a generally cylindrical configuration that defines a cylindrical receiving region C and driving surfaces 124 corresponding to those of transmitter 120 (FIG. 6).
- transmitter 120 ′ comprises a receiving ferrule 120 b that extends axially from bearing surface 120 a in a direction opposite from driving surfaces 124 .
- Receiving ferrule 120 b defines an interior region that is dimensioned and configured to receive the seal cap on a conventional sample blood collection tube.
- receiving ferrule 120 b carries a leaf spring 120 e which may optionally be formed integrally therewith as shown in the Figure.
- Leaf spring 120 c protrudes into the interior region of receiving ferrule 120 b and it is configured so that it will be displaced by a sample collection tube inserted therein.
- a collection tube such as blood collection tube 56 a , which carries a seal cap 56 b , may be inserted into the cylindrical shell 138 and thus into the receiving ferrule 120 b of transmitter 120 ′ therein.
- seal cap 56 b will displace leaf spring 120 c outwardly.
- Leaf spring 120 c is configured so that such displacement causes it to bear against the interior of the holder shell, thus increasing the friction between transmitter 120 ′ and the surrounding shell 138 . This added friction helps keep tube 56 a in place during the filling process despite the bias of spring 154 .
- FIG. 9A provides a schematic illustration of a lever-based mechanism for the present invention.
- Mechanism 242 makes use of a ring lever 210 , shown in plan view in FIG. 9B and in perspective view in FIG. 9C.
- Ring lever 210 is configured in the shape of a ring having a pair of fulcrum studs 212 extending outwardly and coaxially therefrom. Studs 212 define the fulcrum of lever ring 210 and divide ring 210 into two roughly semicircular arms 212 a and 212 b that extend therefrom. As sensed in FIG.
- arm 212 a extends upward (or forward) and comprises a pintle 218 a for connecting to the actuator 230 in a hinge-like manner that permits pintle 218 a to move radially so that ring lever 210 can pivot.
- Arm 212 b extends downward (rearward) and comprises a bearing portion 218 b for engaging the transmitter baffle 220 in a manner that allows movement corresponding to that of pintle 218 a on actuator frame 230 .
- the central region 216 (FIG. 9B) of ring 210 is configured to allow the blunting member and associated shuttle to pass therethrough.
- ring lever 210 is mounted inside holder shell 238 with studs 212 rotatably disposed at right angles to the longitudinal axis of the shell.
- Pintle 218 a is connected to an actuator frame 230 by engaging a lift arm 230 a connected thereto.
- a transmitter baffle 220 is mounted within shell 238 for axial sliding motion between a stop member 238 a on shell 238 and frame 230 .
- Transmitter baffle 220 defines a large internal aperture (not shown) to permit the filling needle at the rearward end of the blunting member, and the blunting member shuttle 24 to pass therethrough.
- a spring 54 is partially compressed between shuttle flanges 32 and baffle 220 .
- Actuator frame 230 is slidably disposed within shell 238 . It will be apparent that the insertion of a sample collection tube that is pressed against transmitter baffle 220 will apply a force on bearing portion 218 b of ring lever 210 at an end thereof opposite from pintle 218 a , corresponding to force F 1 (FIG. 9C). Ring lever 210 will rotate about studs 212 causing pintle 218 a to move in the contrary direction indicated by arrow F 2 (FIG. 9C). Since pintle 218 a engages the slidable actuator frame 230 , the upward (as sensed in FIG. 9A) movement of baffle 220 produces a contrary, downward motion of frame 230 .
- Actuator frame 230 is configured similarly to actuator ferrule 50 of mechanism 42 (FIG. 3) insofar as it permits the initial installation of needle assembly 30 in shell 238 in the sharp configuration while the mechanism remains in the pre-filling configuration of FIG. 9A.
- the internal configuration of actuator frame 230 will cause it to release detent 28 when it moves rearward (downward as sensed in FIG. 9A) in response to the first insertion of a sample tube into shell 238 . Then, the needle is sharp while the device is in the filling configuration.
- spring 54 Upon the subsequent removal of the sample collection tube, spring 54 will push shuttle 24 (and the actuator frame 230 bearing thereon) upward, thus moving the mechanism to the deployed configuration and the needle assembly (not fully shown) to the blunted configuration.
- mechanism 242 ′ comprises a transmitter baffle 220 ′, a ring lever 210 ′ and an actuator 230 ′ that are integrally interconnected by hinge straps 218 a ′ and 218 b ′ that are secured thereto.
- mechanism 242 may be considered a single piece.
- Hinge straps 218 a ′, 218 b ′ are sufficiently pliable to allow the necessary movement between lever 210 ′ and draw transmitter baffle 220 ′ and actuator 230 ′ as lever 210 ′ pivots to draw baffle 220 ′ and actuator 230 ′ towards each other and then push them apart.
- Strap hinges 218 a ′ and 218 b ′ may be formed, for example, from a polymeric material.
- transmitter baffle 220 ′ and/or actuator 230 ′ may be formed from the same material as the hinge strap connected thereto and they may be molded together with the hinge strap in a single operation, leaving a distal end of the hinge strap free to be secured to another structure of mechanism 242 ′.
- lever 210 ′ may be formed with hinge straps 218 a ′ and 218 b ′ extending therefrom, and the distal ends of the straps may be secured to baffle 220 ′ and actuator 230 ′ by any suitable method, e.g., by adhesive, sonic welding, etc.
- mechanism 242 ′ might be formed as a whole in a single molding operation.
- a mechanism 342 shown in FIG. 10A comprises pliable, resilient straps 310 connecting a transmitting sleeve 320 and an actuator ferrule 350 .
- Straps 310 are configured to have a reverse bend about pins 348 , and so extend forward from the forward edge of transmitting sleeve 320 , around pins 348 to actuator ferrule 350 , from which it extends forward as well. In the region of the reverse bend around pins 348 , straps 310 may slidably bear against the interior of forward end 36 a of holder 36 .
- FIG. 10A shows the device in a blunted configuration corresponding to the configuration shown in FIG. 4B.
- straps 310 constitute a reversing link between the transmitting sleeve 320 and the actuator ferrule 350 , performing an equivalent function to the gear and toothed splines of the embodiment of FIG. 3.
- the transmitter is movable axially, i.e., longitudinally, in the shell, and it is not fastened to the shell.
- the transmitter device may move directly or indirectly to and fro relative to the central axis of the shell, thus moving obliquely relative to the motion of a sample collection tube being inserted into, or withdrawn from, the shell.
- Such radial motion is also oblique relative to the axial forward and rearward motions of the actuator.
- the transmitter device may optionally be fastened to the shell, since no substantial axial movement is required of it.
- the transmitter device may comprise at least one, preferably at least two, resilient arms secured to the interior of the holder.
- the transmitter device i.e., one or more transmitter arms, is configured so that when a collection tube is inserted into the holder, the tube bears against it and presses it sideways towards the shell of the holder. Thus, the transmitter device moves obliquely relative to the collection tube.
- a linkage between the transmitter device and the actuator, such as a cam and follower engagement between them, converts the oblique (sideways) motion of the transmitter device into forward or rearward motion of the actuator.
- the transmitter device moves obliquely relative to the actuator.
- a blood collection needle 455 comprises a holder 436 in accordance with the present invention.
- Holder 436 comprises a cylindrical shell 438 which has a front end 436 a and a back end 436 b and a mechanism 442 therein, described below.
- shell 438 defines a needle hub 410 in which a needle cannula 422 is mounted.
- Back end 436 b and shell 438 are dimensioned and configured to receive a sample collection tube therein.
- the transmitter device comprises a set of resilient transmitting arms 444 a which are mounted in the interior of shell 438 and which extend forwardly in the interior of the shell. Transmitting arms 444 a also extend towards the central axis of the shell so that when a sample collection tube is inserted in the back end of holder 436 , it bears against transmitting arms 444 a .
- Transmitting arms 444 a being flexible and resilient, are displaced from the central region of shell 438 towards the wall of the shell as the sample collection tube moves forward in holder 436 , and transmitting arms 444 a move inwardly as the sample collection tube is withdrawn, i.e., the arms move obliquely (i.e., radially) relative to the generally axial motion of the sample collection tube.
- transmitting arms 444 a are fastened to the shell near the back end of the shell and extend forwardly therein (in other embodiments, they might extend rearwardly from the front).
- Each of transmitting arms 444 a carries a wedge 446 a which points outwardly, towards shell 438 , and each wedge has a cam surface S.
- Blunting mechanism 442 also comprises a ferrule-shaped actuator 450 disposed within shell 438 .
- Actuator 450 is dimensioned and configured to receive therein the transmitting arms 444 a .
- Actuator 450 comprises a cannula hub 451 which engages a second cannula 426 which extends forwardly therefrom and is disposed concentrically within needle cannula 422 .
- the forward-extending portion of cannula 426 terminates with a blunt end and constitutes the blunting member 426 a of the device.
- Cannula 426 also extends rearward, terminating at a sharp end for puncturing the seal on a sample collection tube and for providing a conduit for fluid flow between the sample collection tube in holder 436 and needle cannula 422 .
- the sharp end of cannula 426 is covered with a self-resealing boot 427 which blocks fluid flow from the tip end of cannula 426 until the boot is displaced by a collection tube.
- the boot re-seals cannula 426 when the collection tube is removed, as is known in the art.
- Cannula 426 is secured to actuator 450 so that it moves with actuator 450 .
- a spiral spring 454 is positioned within shell 438 to urge actuator 450 forward and serves as a biasing member in this embodiment.
- biasing members e.g., other types of springs, an elastic band, etc.
- spring 454 may be used as a biasing means in place of spring 454 . Since the annular portion of actuator 450 extends rearward from hub 451 , it is configured to seat the end of a sample collection tube and permit the blunting cannula to perforate the seal on the collection tube.
- Needle cannula 422 , second cannula 426 , actuator 450 , transmitter arms 444 a and shell 438 are dimensioned and configured so that when actuator 450 is in its forward-most position within shell 438 , blunting member 426 a extends beyond the sharp tip of needle cannula 422 , thus blunting the device, Le., the device is in a blunted configuration. They are further configured so that when actuator 450 is moved rearward under the operation of mechanism 442 , the blunt end of blunting member 426 a is withdrawn into needle cannula 426 , thus exposing the sharp tip of the needle and placing the device in a sharpened configuration, as follows. Actuator 450 is equipped with wedge apertures 452 .
- Arms 444 a and wedges 446 a are configured so that when a sample tube is inserted into holder 436 , the tube bears against arms 444 a , pushing them outward so that surfaces S engage the rearward interior edge of wedge apertures 452 .
- wedges 446 a are driven farther outward and actuator 450 rides along surfaces S and is thus moved backward in the device.
- surfaces S serve as cam surfaces and actuator 450 serves as a cam follower.
- arms 444 a are configured so that the sample collection tube contacts arms 444 a at a point between their connection to shell 438 and their linkage to actuator 450 .
- the arms 444 a flex about their points of attachment to shell 438 , which serve as their fulcrums. It may be noted that the arms 444 a move in response to a force applied by the sample tube between the fulcrum and the load (actuator 450 ), so arms 444 a act as levers of the third class.
- shell 438 may comprise shell apertures 438 a to accommodate the protrusion of wedges 446 a entirely through wedge apertures 452 .
- actuator 450 When actuator 450 begins in its forwardmost position (the blunting position) and is then moved rearward by arms 444 a and wedges 446 a , blunting member 426 a is withdrawn from its blunting position towards a position within needle cannula 422 (the sharpened position), thus sharpening the device.
- Arms 444 a may be configured to cause actuator 450 to fully withdraw blunting member 426 a into needle cannula 422 , which is typically achieved with a travel of about 0.2 inch.
- the resilience of arms 444 a causes them to return towards the central region in shell 438 , and surfaces S then permit actuator 450 to advance under the impetus of spring 454 .
- a positive motion cam may be established between arms 444 a and actuator 450 and the spring-like arms 444 a may comprise the biasing means due to their resiliency to advance the actuator 450 when arms 444 a resume their inwardly-disposed configuration.
- a holder 436 shown in FIGS. 12A, 12B and 12 C, comprises a transmitter device comprising a first set of arms 444 b with wedges 446 b which may be configured to withdraw the actuator 450 ′ and a blunting member (not shown) only part way, e.g., 0.1 inch.
- the transmitter device further comprises a second set of arms 444 c and wedges 446 c , and an actuator 450 ′ and shell 438 ′ which comprise apertures to accommodate both sets of wedges in a manner similar to that shown in FIG. 11.
- the second set of wedges 446 c may be situated at a different point on the front-to-back length of shell 438 than the first set of wedges 446 b .
- the mechanical action of the two sets of wedges is staggered.
- Each set may separately accomplish a part, e.g., approximately half, of the withdrawal motion to move blunting member 426 a from its extended, blunting position to its withdrawn, sharpened position, over different (although possibly overlapping) time intervals from the other set of wedges as the sample collection tube is inserted into the holder.
- arms 444 b in shell 438 ′ are configured for the first contact with a sample collection tube and wedges 446 b thereon are configured to effect a first portion of the rearward motion of actuator 450 ′ by engaging apertures 438 b .
- Arms 444 c are configured for contact with the sample collection tube after arms 444 b , and wedges 446 c thereon are configured to effect the completion of the rearward motion of actuator 450 ′ by engaging apertures 438 c to sharpen the device.
- FIG. 12C provides an end view in which both sets of arms 444 b and 444 c are visible.
- the transmitter arms can be extended beyond the wedges to include locking detents to retain the actuator in the withdrawn position prior to the first insertion of a sample collection tube into the device.
- holder 436 ′′ of FIG. 13A comprises arms 444 d which carry wedges 446 d for engaging wedge apertures 452 e .
- Arms 444 d carry locking extensions 444 e which terminate in locking detents 446 b .
- Actuator 450 ′′ is provided with corresponding locking apertures 450 f configured so that when actuator 450 ′′ is in an initial, rearward position, locking tabs 446 b engage the front surface of actuator 450 ′′ via locking apertures 450 f , as seen in FIG. 13B.
- Locking apertures 450 f are dimensioned to permit arms 444 d to move outwardly (i.e., radially relative to the central axis of shell 438 , with which cannula 426 is aligned) and thus disengage tabs 446 b from the actuator.
- Arms 444 a are configured so that upon the initial insertion of a sample collection tube into shell 438 , the arms are moved apart sufficiently to disengage locking tabs 446 b from actuator 450 ′′ as indicated by arrows 453 . Actuator 450 ′′ is then free to move forward under the pressure of a spring (not shown) like spring 454 (FIG. 11). As the sample tube is inserted further, however, the mechanism in the holder causes actuator 450 ′′ to move rearward again. The sample tube spreads arms 444 d so that they pass through apertures 450 f as actuator 450 ′′ moves rearward to a retracted position to sharpen the device.
- a spring not shown
- actuator 450 ′′ moves forward, but the sample tube prevents tabs 446 b from engaging the notches in apertures 450 f Instead, actuator 450 ′′ moves forward beyond the notches and beyond the ends of extensions 444 e .
- arms 444 can move towards the center of the device and actuator 450 ′′ is fully advanced so that the blunting member blunts the needle cannula.
- the ends of arms 444 can then move toward the center of the shell into position to bear against the central portion of the actuator, as shown in FIG. 13C, and prevent actuator 450 ′′ from moving rearward, thus locking the device in the blunted configuration.
- arm extensions 444 e When another sample collection tube is inserted into the device, arm extensions 444 e will be driven outward so that they align with apertures 450 f and they will thus permit the mechanism to move the blunting member rearward to sharpen the device. It will therefore be understood that tabs 446 b only hold actuator 450 ′′ in the forward position in an initial configuration prior to the first insertion of a sample collection tube into the needle.
- a blood collection needle comprising holder 436 ′′ is initially provided in an initial sharpened configuration in which actuator 450 ′′ and a second (blunting) cannula (not shown) are withdrawn to the sharpened position and actuator 450 ′′ is engaged by locking tabs 446 b (FIGS. 13A and 13B).
- actuator 450 ′′ and a second (blunting) cannula are withdrawn to the sharpened position and actuator 450 ′′ is engaged by locking tabs 446 b (FIGS. 13A and 13B).
- the user can effect venipuncture with the needle cannula (not shown) in hub 410 and with the cannula boot (not shown) preventing fluid flow.
- FIGS. 14A through 15 Still another embodiment in accordance with the present invention is shown in FIGS. 14A through 15.
- the transmitter device comprises two transmitter arms, each attached to one side of the interior of the holder and extending towards the other side.
- the transmitter arms terminate in lugs which ride on cam surfaces formed on the actuator.
- FIG. 14A shows a holder 536 for a blood collection needle comprising a shell 538 which has a generally cylindrical configuration with a front end 538 a in which is formed a needle aperture 540 within which the needle may be mounted.
- needle aperture 540 may be configured in the same manner as the mounting portion 14 a of needle hub 10 (FIG. 1A), which has funnel-like insertion regions to facilitate the insertion of the needle therein and of the blunting member into the needle cannula.
- shell 538 At the back end 538 b , shell 538 comprises a finger flange 538 c for the convenience of the user.
- mechanism 542 effects rearward motion of a blunting member (to sharpen the device) in response to the insertion of a sample collection tube in the device.
- Mechanism 542 comprises transmitter arms 546 a , 546 b , actuator 550 and spring 554 .
- Transmitter arm 546 b is attached to shell 538 at the back end thereof and extends in a forward direction and generally traverses the central, interior portion of the shell (from left to right as sensed in FIG. 14A) to terminate at lug 548 b .
- Transmitter arm 546 a is configured similarly to arm 546 b , but it is attached on the shell at a point generally opposite from where arm 546 b is attached and it traverses the central portion of shell 538 in the opposite direction, as suggested in FIG. 14A.
- Actuator 550 carries a mounting lug in which a mounting aperture 524 is formed for receiving a blunting member.
- Actuator 550 also carries wedges 550 a , 550 b , each of which forms a cam surface 552 a , 552 b , respectively.
- Lug 548 a is positioned to bear against cam surface 552 a
- lug 548 b is positioned to bear against cam surface 552 b .
- actuator 550 is in the forwardmost position under the bias of spring 554 , with lugs 548 a and 548 b at their lowest points on their respective cam surfaces 552 a , 552 b .
- FIG. 14A and 14B In the view of FIG.
- actuator 550 defines a pair of generally parallel slots 550 c and 550 d which straddle aperture 524 and that wedges 550 a and 550 b are formed alongside the slots.
- Slots 550 c and 550 d admit arms 546 a and 546 b therethrough to allow lugs 548 a to rest on cam surface 552 a and lug 548 b to rest on cam surface 552 b .
- cam surface 552 b is inclined away from the viewer, and so is not visible in these Figures.
- FIG. 14 a it can be understood that when a sample collection tube is inserted into holder 536 , it will bear against the mid-portions of transmitter arms 546 a and 546 b , between where arms 546 a and 546 b are attached to shell 538 and where they engage actuator 550 , and bend them towards the sides of shell 538 to which they are attached. Lugs 548 a and 548 b will then bear against cam surfaces 552 a and 552 b , thus moving actuator 550 rear-ward (downward as sensed in FIGS. 14A and 14B) against the bias of spring 554 . The result of such an arrangement is shown in FIG.
- Lugs 548 a and 548 b rest at the top of cam surfaces 552 a and 552 b , respectively and have driven actuator 550 rearward, thus compressing spring 554 .
- the blunting member 26 a carried on actuator 550 is moved rearward in the device to the blunting configuration, leaving the tip of needle 26 exposed.
- any of the embodiments of FIGS. 11-15 may easily be configured to receive a removable needle and blunting member assembly of the kind shown in U.S. Pat. No. 5,951,520, the disclosure of which is hereby incorporated herein by reference.
Abstract
Disclosed herein is a blood collection system comprising a blood collection tube, a tube holder, and a self-blunting blood collection needle. A blunting member is deployed upon withdrawal of a blood collection tube from the tube holder, to blunt the needle and so safeguard the patient and the technician from inadvertent needle sticks. The blunting member is retracted to re-sharpen the needle when a subsequent collection tube is inserted into the holder. The mechanism effects blunting and re-sharpening of the needle without requiring that the technician manipulate the mechanism in a manner different from that of conventional, non-blunting blood collection needles. Four types of mechanisms are disclosed: a rack and pinion mechanism; a cylindrical cam mechanism; lever mechanisms and a reversing strap mechanism.
Description
- This application is a continuation of U.S. application Ser. No. 09/649,773, filed on Aug. 29, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/199,742, filed on Nov. 25, 1998, now U.S. Pat. No. 6,146,337, which claims the benefit of U.S. Provisional Application No. 60/211,897, filed Jun. 16, 2000, the disclosures all of which are incorporated by reference.
- The present invention pertains to self-blunting needle devices and, in particular, to holders for blood collection needles.
- Conventional blood collection systems are known in the art to comprise a holder, typically in the form of a generally cylindrical shell that holds a double-ended needle cannula. One end of the needle cannula extends forward from the holder and is used for venipuncture (the “venipuncture needle”), while the other end (the “filling needle”) extends into the holder and is used to puncture the seal cap on a sample fluid collection tube (which, typically, is vacuum sealed). The device is used by unsheathing the venipuncture needle and effecting venipuncture and then inserting the sealed end of a collection tube into the holder and pushing the seal cap against the boot that covers the tip of the filling needle. The filling needle pierces the boot and the seal cap and blood is drawn into the collection tube. If additional samples are required, the first collection tube is removed and a second collection tube is pushed into the holder in its place. When the last tube is filled, the blood collection needle is withdrawn from the patient's vein.
- Prior art self-blunting blood collection needles have provided a deployable, locking, blunting member to protect the user against inadvertent needle sticks but required the user to engage in an extraneous manipulation of the sample tube in order to deploy the blunting member such as the insertion of the sample tube past a discernible “stop” point at which the collection tube is already fully engaged by the filling needle. There is need, therefore, for a self blunting needle mechanism that does not require manipulation beyond that which is familiar to medical technicians with the use of conventional blood collection needles.
- The present invention relates to a needle holder apparatus comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein and for carrying thereon a needle cannula, an actuator movably disposed in the shell for engaging and moving a blunting member longitudinally within the shell and means for moving the actuator between a forward position and a retracted position in response to the insertion and withdrawal of a sample collection tube in the shell.
- According to one aspect of the invention, the means for moving the actuator may comprise a transmitter device connected to the shell and being configured to move obliquely in the shell upon insertion of such sample collection tube into the shell. There may also be a linkage between the transmitter device and the actuator to convert the oblique motion of the transmitter device into rearward motion of the actuator when such sample tube is inserted into the apparatus. The apparatus may include a biasing member positioned and configured to urge the actuator toward the forward position.
- In one species of the invention, the linkage may comprise a cam and follower engagement between the actuator and the transmitter device. Optionally, there may be a staggered cam and follower engagement between the actuator and the transmitter device.
- According to yet another aspect of the invention, the transmitter device may be configured to contact such sample collection tube at a point between the connection to the shell and the linkage to the actuator.
- According to yet another aspect of the invention, the transmitter device may extend forwardly in the shell from its point of attachment to the shell.
- According to still another embodiment of the invention, the transmitter device may comprise at least two transmitter arms.
- According to another aspect of the invention, either of the actuator and the transmitter device may comprise a cam surface.
- The apparatus may comprise a biasing member urging the actuator member toward the forward position.
- In a particular embodiment, this invention may provide a needle holder apparatus comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein and for carrying thereon a needle cannula, an actuator movably disposed in the shell for engaging and moving a blunting member axially within the shell, a transmitter device connected to the shell and being configured to contact a sample collection tube which may be inserted into the shell and to move obliquely relative to the motion of the sample collection tube, and a positive motion cam engagement between the transmitter device and the actuator to convert the oblique motion of the transmitter device into axial motion of the actuator, to move the actuator axially in the shell in response to the oblique motion of the transmitter device, wherein the apparatus is biased to dispose the actuator in the forward position.
- The present invention also provides a blood collection needle comprising a shell dimensioned and configured for receiving and holding a sample collection tube therein, a needle cannula carried on the shell, a blunting member disposed telescopically within the needle cannula for movement between a withdrawn position which disposes the needle in a sharpened configuration and a blunting position which disposes the needle in a blunted configuration, and a mechanism for moving the blunting member to the withdrawn position when a sample collection tube is inserted into the holder and for moving the blunting member to the blunting position when the sample collection tube is withdrawn from the shell.
- In a particular embodiment, the mechanism may comprise an actuator movably disposed in the shell, the actuator being secured to the blunting member so that the blunting member can be moved between the blunting position and the withdrawn position by movement of the actuator, a movable transmitter device connected to the shell and being configured for contact with a sample collection tube which may be inserted into the shell and to move obliquely relative to the motion of a sample collection tube in the shell, a biasing member configured to urge the blunting member to the blunting position upon withdrawal of a sample collection tube from the shell, and a linkage between the transmitter device and the actuator to convert the oblique motion of the transmitter device into forward and rearward motion of the actuator, to move the blunting member from the blunting position to the withdrawn position.
- Further details concerning the invention are described below with reference to the appended Figures.
- FIG. 1A is a cross-sectional view of a needle hub for holding a needle cannula in a blood collection device;
- FIG. 1B is a perspective view of a blunting member shuttle intended for use with the needle hub of FIG. 1A;
- FIG. 1C is a view of the shuttle of FIG. 1B taken along line1C-1C;
- FIG. 1D is a cross-sectional view of a safety needle assembly comprising the hub and shuttle of FIGS. 1A and 1B with a needle cannula and blunting cannula secured therein;
- FIG. 2 is a cross-sectional view of a collection tube holder and a blunting mechanism for use with the present invention;
- FIG. 3 is a cross-sectional view of a passive blood collection needle in accordance with a particular embodiment of the present invention, comprising the holder and blunting mechanism of FIG. 2 and the needle assembly of FIG. 1D;
- FIGS. 4A and 4B are views similar to FIG. 3 of the device of FIG. 3 in the insertion and blunted configurations, respectively;
- FIG. 5A is a schematic plan view of a rotator element for use in a blunting mechanism in accordance with another embodiment of the present invention;
- FIG. 5B is a cross-sectional view of the element of FIG. 5A taken along line5B-5B;
- FIG. 5C is a cross-sectional view of the element of FIG. 5A taken along
line 5C-5C; - FIG. 6 is an exploded perspective view of a transmitter element and an actuator element for use with the rotator element of FIG. 5A in a blunting mechanism in accordance with the present invention;
- FIG. 7A is a perspective view of a sample tube holder for use with the elements shown in FIGS. 5A and 6;
- FIG. 7B is a view of the holder of FIG. 7A taken along
line 7B-7B; - FIGS. 8A and 8B are schematic cross-sectional views of a passive blood collection needle comprising the elements shown in FIGS. 5A, 6 and7A, in the blunted and insertion configurations, respectively, with the needle assembly omitted to clarify the drawing;
- FIG. 8C is a view similar to FIGS. 8A and 8B of the blunting mechanism as it will be configured upon the initial installation of a locked needle assembly prior to insertion of a sample collection tube;
- FIG. 8D is an elevation view of a transmitter device of a blunting mechanism according to yet another embodiment of this invention;
- FIG. 8E is an elevation view of the transmitter device of FIG. 8D together with a blood collection tube in a holder shell shown in cross section;
- FIG. 9A is a cross-sectional schematic view of a blunting mechanism in a needle holder in accordance with a first lever embodiment of the present invention;
- FIG. 9B is a plan view of
ring lever 210 of FIG. 9A; - FIG. 9C is a perspective view of the
ring lever 210 of FIG. 9B; - FIG. 9D is a perspective view of an alternative embodiment of a lever-type mechanism similar to the one of FIGS. 9A-9C;
- FIGS. 10A and 10B are schematic cross-sectional views of a blood collection needle in accordance with still another embodiment of the present invention;
- FIG. 11 is a schematic cross-sectional view of a blood collection needle comprising a needle holder in accordance with another lever embodiment of the present invention;
- FIGS. 12A and 12B are cross-sectional views of a holder for a blood collection needle in accordance with another embodiment of the invention;
- FIG. 12C is an end view of the embodiment of FIGS. 12A and 12B;
- FIG. 13A is a cross-sectional view of a holder according to yet another embodiment of the invention;
- FIG. 13B is a partial perspective view of an arm extension and actuator of FIG. 13A shown in an initial, blunted configuration without a sample tube in the device;
- FIG. 13C is a view of the structures of FIG. 13B locked in a blunted position after the withdrawal of a sample tube from the device;
- FIG. 14A is a schematic view of a needle holder in accordance with still another embodiment of the invention;
- FIG. 14B is a view of the holder of FIG. 14A taken generally along the line indicated at B-B in FIG. 14A;
- FIG. 14C is a perspective view of the transmitter arms and actuator of the mechanism shown in FIG. 14A; and
- FIG. 15 is a schematic view of the holder of FIG. 14A with a needle, blunting member and sample collection tube therein, and with the device in the sharpened configuration.
- The present invention relates to a holder for a blood collection needle having a movable blunting member. The holder has a mechanism for engaging and deploying a blunting member upon withdrawal of a blood collection tube from the tube holder, to blunt the venipuncture needle and so safeguard the patient and the technician from inadvertent needle sticks. The mechanism may function to retract the blunting member to re-sharpen the venipuncture needle when a subsequent collection tube is inserted into the holder. The mechanism is responsive to the insertion and withdrawal of the blood collection tube to retract and deploy the blunting member accordingly. One basic and novel feature of the present invention is that the mechanism allows the user to blunt and, optionally, re-sharpen the venipuncture needle without requiring manipulation of the collection tube or the needle holder other than that normally performed for conventional blood collection needle systems, as described above. For example, it is not necessary to manipulate the blunting member in any manner other than by the insertion or withdrawal of the sample tube to engage or disengage the filling needle. Four types of mechanisms are disclosed: a rack and pinion mechanism, a cylindrical cam mechanism, a lever mechanism, and a pliable, resilient strap mechanism. Generally, the mechanism in each of these devices comprises an actuator member which engages the blunting member for movement in the holder between a forward or deployed position which places the device in a blunted configuration and a rearward or withdrawn position which places the device in a sharpened configuration. The mechanism also comprises a transmitter which is moved by a sample collection tube as the tube is inserted into or removed from the device. The mechanism is designed to convert motion imposed on the transmitter device upon insertion of a sample collection tube as it is inserted into the device into a rearward motion of the actuator and consequently into withdrawal of a blunting member, if one is secured to the actuator.
- In some embodiments the transmitter moves forward or rearward in the device with the sample collection tube and the mechanism includes a reversing member for imparting a motion on the actuator in a direction opposite to that of the transmitter device. In other embodiments, the mechanism includes a cam and follower engagement between the transmitter and the actuator. In another embodiment, the transmitter movers obliquely relative to the sample collection tube.
- Also disclosed is an optional safety needle assembly comprising a needle cannula mounted in a needle hub combined with a blunting member mounted in a shuttle. The blunting member is designed to be received within the needle cannula and the shuttle is configured to be received within the needle hub. A locking mechanism comprising a detent resiliently mounted on the shuttle is configured to releasably engage locking apertures in the needle hub. The locking mechanism and the blunting mechanism may be used together by configuring the blunting mechanisms to release the detent from the locking apertures when the needle assembly is installed in the needle holder.
- FIG. 1A shows a
needle hub 10 that comprises a generallycylindrical body 12 having a longitudinal axis A, afirst end 12 a and asecond end 12 b.Needle hub 10 also comprises acircumferential locking flange 18 and at least one locking spline 20 (FIG. 1D) by whichneedle hub 10 can be secured in a needle holder, as described below. The interior ofneedle hub 10 comprises ahub passageway 14 extending therethrough. Theshuttle portion 14 b of passageway 14 (generally betweensecond end 12 b and flange 18) is dimensioned and configured to slidably receive a shuttle (FIG. 1B) therein.Body 12 defines twolocking notches channel 16 c formed together as an aperture through the cylindrical wall ofbody 12. The mounting portion 14 a of passageway 14 (generally betweenflange 18 andfirst end 12 a) is dimensioned and configured to receive a needle cannula in the forward end thereof. The funnel-like insertion regions passageway 14 converge from theshuttle portion 14 b and the first end ofhub 10, respectively, and facilitate the insertion therein of a blunting member and a needle cannula in assembly steps described below. - FIG. 1B shows a blunting
member shuttle 24 which has a generally cylindrical body that is dimensioned and configured to be slidably received within theshuttle portion 14 b ofpassageway 14 ofhub 10, as will be described below.Shuttle 24 defines a centralaxial passageway 24 a therethrough within which may be mounted a blunting member.Shuttle 24 comprises adetent 28 that is mounted on the end of aresilient arm 24 b.Resilient arm 24 b suspendsdetent 28 at a stand-off from the remainder of the shuttle body, indicated as stand-off S in the end view of FIG. 1C. As is evident from FIG. 1C,detent 28 has a protrudingsurface 28 a that is disposed obliquely relative to the cylindrical periphery ofshuttle 24. Therefore, a force applied uponsurface 28 a substantially along a tangent to the shuttle body (or parallel to such a tangent) can drivedetent 28 in a radial direction (towardspassageway 24 a), narrowing stand-off S by flexingarm 24 b. -
Shuttle 24 comprisesshuttle flanges 32 that permitshuttle 24 to engage another structure, as described below.Shuttle 24 also defines aboot barb 34 on which a self-sealing boot for sealing the sharpenedinsertion end 26 b of bluntingmember cannula 26 may be anchored, as is well-known in the art. - FIG. 1D shows a
safety needle assembly 30 that comprisesneedle hub 10, ahollow needle cannula 22 mounted therein,shuttle 24 and a hollowsecond cannula 26 mounted therein.Needle cannula 22 has a blunt proximal end that is inserted into thefirst end 12 a ofhub 10 and is secured therein by means of adhesive (not shown). The distal end ofneedle cannula 22 comprises a puncture tip.Passageway 14 defines aproximal insertion region 14 d that converges rearward fromfirst end 12 a and thus facilitates the insertion of the blunt end ofneedle cannula 22 intopassageway 14. Theshuttle portion 14 b ofpassageway 14 is dimensioned and configured to slidably receiveshuttle 24 therein. A portion ofsecond cannula 26 extends forward fromshuttle 24 throughpassageway 14 and intoneedle cannula 22, within which it is telescopically disposed and wherein it terminates at a first, blunt end. The forward extending portion ofsecond cannula 26 is referred to herein as the bluntingmember 26 a.Second cannula 26 andneedle cannula 22 cooperate to form a fluid flow passageway that extends through both of them. Thus, the bluntingmember 26 a and theneedle cannula 22 are disposed telescopically one within the other without obstructing flow through the needle passageway. Preferably,insertion region 14 c converges to a diameter that is smaller than the internal diameter ofneedle cannula 22 and it is aligned therewith so that it provides a stop for the insertion ofneedle cannula 22 intobody 12 as well as guiding bluntingmember 26 a of bluntingmember cannula 26 into the proximal end ofneedle cannula 22.Second cannula 26 also extends rearward fromshuttle 24, terminating at a second, sharp end (sometimes referred to herein as a “filling needle”) for puncturing the seal on a collection tube and for providing a conduit to establish fluid flow communication between the collection tube andneedle cannula 22, as will be described below.Second cannula 26 is securely mounted withinshuttle 24 so that it moves withshuttle 24. -
Detent 28 onshuttle 24 is dimensioned and configured to protrude through, and to be secured within, lockingnotches shuttle 24 andneedle hub 10. FIG. 1D showsneedle assembly 30 in an insertion configuration (sometimes referred to herein as the “sharp configuration”), in which shuttle 24 is in a retracted position inhub 10. As shown,assembly 30 is locked in the sharp configuration by the engagement ofdetent 28 inrear locking notch 16 b. Pressingdetent 28 intopassageway 14 disengages the detent fromnotch 16 b so thatshuttle 24 may be advanced withinpassageway 14.Detent 28 can slide alongchannel 16 c until it engages forward lockingnotch 16 a, thus securingshuttle 24 in an advanced or extended position withinneedle hub 10, resulting in a blunted configuration in which the blunt end of bluntingmember 26 a protrudes beyond the sharp tip of needle cannula 22 (as indicated in dotted outline), blunting the needle assembly. - One embodiment of a needle assembly holder in accordance with the present invention is shown in FIG. 2.
Holder 36 comprises acylindrical shell 38 that defines a needle aperture 40 at its forward end. Aperture 40 is dimensioned and configured to receive a needle assembly comprising a needle cannula and a blunting member that are telescopically and movably disposed one within the other, such as needle assembly 30 (FIG. 1D). Anannular flange 40 a protrudes into aperture 40 and defines notches (not shown) that are sized to allowspline 20 anddetent 28 to pass therethrough asneedle hub 10 is inserted into aperture 40.Flange 40 a, however, is dimensioned and configured to engagehub flange 18 of needle assembly 30 (FIG. 1D).Flange 40 a may be configured to be received in a friction fit betweenflanges 18 and spline 20 (FIG. 1D) whenhub 10 is inserted into aperture 40 as far asflanges spline 20 out of alignment with the notch inflange 40 a. A stop lug (not shown) is positioned in aperture 40 to engagespline 20 upon such rotation and thus limit the rotation to a suitable turn, e.g., 45 degrees.Needle assembly 30 may thus be mounted inholder shell 38. -
Shell 38 contains amechanism 42.Mechanism 42 comprises a transmittingsleeve 44 comprisingracks 46 which, in the illustrated embodiment, comprise toothed splines.Mechanism 42 further comprisespinions 48 which, in the illustrated embodiment, comprise toothed gears, and anactuator ferrule 50 comprisingracks 52.Mechanism 42 also includes aspring 54.Pinions 48 engageracks sleeve 44 is slidably disposed in the interior ofshell 38 andracks 46, which are preferably diametrically opposed from one another inshell 38, are slidably disposed in axial grooves in the interior wall ofshell 38. Transmittingsleeve 44 has at itscoupling end 44 a anaccess aperture 44 b. Couplingend 44 a is dimensioned and configured to engage the filling end of a conventional collection tube andaperture 44 b permits the sharp end of a filling needle such as the end of cannula 26 (FIG. 1D) to protrude therethrough into a collection tube. Pinions 48 are mounted inshell 38 and are dimensioned and configured to rotatably engageracks 46 of transmittingsleeve 44. FIG. 2 showsmechanism 42 in a deployed configuration, i.e., a configuration in which actuatorferrule 50 is positioned forward inshell 38, where it can be retracted or withdrawn (moved downward, as sensed in the Figure), as will be described herein. (This position is referred to as “deployed”. When the actuator ferrule engages a blunting member in this position, the blunting member is extended, to blunt the needle, as will be described herein.)Spring 54, betweenend cap 50 a ofactuator ferrule 50 and transmittingsleeve 44, is lightly compressed to bias the mechanism into the illustrated pre-filling position and is situated so that it is tensioned against the transmittingsleeve 44 when transmittingsleeve 44 andactuator ferrule 50 approach each other as described below.Actuator ferrule 50 is disposed withinshell 38 and comprises a pair ofracks 52 that engage pinions 48. The interior offerrule 50 is dimensioned and configured to permit the insertion and rotation ofneedle assembly 30 therein as is necessary to mountneedle assembly 30 inshell 38, without depressing detent 28 (FIG. 1D). For example,ferrule 50 may have an L-shaped groove on its interior surface, withdetent 28 moving in an axial or longitudinal leg of the groove asneedle assembly 30 is inserted intoshell 38.Detent 28 may then move in a circumferential leg of the groove whenneedle assembly 30 is rotated in aperture 40. Alternatively,ferrule 50 may have an internal lug or fillet positioned to engagedetent 28 only afterneedle assembly 30 is mounted inshell 38 andferrule 50 is moved rearward. - Analogously to the interrelation on needle assembly30 (FIG. 1D) of
spline 20 andannular flange 40 a, the shuttle flanges 32 onshuttle 24 are eccentrically configured about the longitudinal axis of the device, andactuator ferrule 50 forms a cap aperture incap 50 a that is configured to align withflanges 32 and permit them to pass therethrough upon initial insertion ofneedle assembly 30 intoshell 38.Spring 54 is configured so that, when theshuttle flanges 32 pass through the aperture incap 50 a, they engagespring 54. The rotation ofneedle assembly 30 that mounts the assembly inshell 38 also turnsflanges 32 out of alignment with the aperture so thatcap 50 a can thereafter engage theflanges 32 under the force ofspring 54.Actuator ferrule 50 can thus engage bluntingmember 26 a, viashuttle 24. -
Mechanism 42 is dimensioned and configured so when transmittingsleeve 44 is moved forward within shell 38 (e.g., as a result of the insertion of a collection tube),actuator ferrule 50 moves in the reverse direction, away fromforward end 36 a, under the operation ofpinions 48.Mechanism 42 thus moves from the pre-filling configuration shown in FIG. 3 to a filling configuration. Such movement also imposes further tension or compressive force onspring 54. - The fully assembled
blood collection needle 55 is shown in FIG. 3 withneedle assembly 30 mounted in aperture 40 (FIG. 2). Theneedle cannula 22 is in fixed relation to the holder because of the engagement ofannular flange 40 a (FIG. 2) with flange 18 (FIG. 1D) and spline 20 (FIG. 1D, not seen in FIG. 3).Collection needle 55 is in an initial, pre-filling configuration in which needleassembly 30 is in a sharpened configuration even thoughactuator ferrule 50 is in a deployed position, becauseshuttle 24 on bluntingmember 26 a has not yet engagedactuator ferrule 50. Note thatshuttle flanges 32 ofneedle assembly 30 protrude beyondend cap 50 a (FIG. 2) offerrule 50 andcompress spring 54.Shuttle 24 resists being moved byspring 54 forward intohub 10 becausedetent 28 is locked innotch 16 b (FIG. 1A), leavingneedle assembly 30 locked in the sharp configuration, ready for venipuncture. - To prepare
blood collection needle 55 for use, a technician will typically installneedle assembly 30 inholder 36 as shown in FIG. 3, and then remove from needle cannula 22 a protective sheath (not shown) and insertneedle cannula 22 into a patient's vein. Then, the technician will take aconventional collection tube 56 a (FIG. 4A) and insert the capped end thereof into theopen end 38 a ofshell 38 with sufficient force to assure that fillingneedle 26 b punctures theseal cap 56 b on the collection tube, thus establishing flow communication between the collection tube and the needle assembly. This action will impose sufficient force on couplingend 44 a to drive transmittingsleeve 44 forward in needle holder 36 (upward as sensed in FIG. 3) and will compressspring 54. The operation ofmechanism 42 will transfer the forward motion of transmittingsleeve 44 into rearward movement ofactuator ferrule 50 indicated by arrows 56 (downward, as sensed in FIG. 3), under the operation ofpinions 48. Thus,mechanism 42 causes actuatorferrule 50 to move in a direction opposite from that of transmittingsleeve 44. The interior offerrule 50 is configured so that such rearward movement causes it to depressdetent 28 and thus unlock the needle assembly.Shuttle flanges 32 then bear onend cap 50 a under the force ofspring 54. This motion will conclude withmechanism 42 in the retracted configuration shown in FIG. 4A, in which actuatorferrule 50 andshuttle 24 are in their retracted positions due to the advancement of transmittingsleeve 44, leavingneedle assembly 30 in the sharpened configuration. With the forward end ofneedle cannula 22 in a patient's vein and the fillingneedle 26 b ofsecond cannula 26 in an evacuated collection tube, blood will flow through the fluid flow passageway of the device to fill the collection tube. It is advantageous for theneedle assembly 30 to be sharp while the sample tube is filling because the filling process may be interrupted if the needle is jostled or obstructed and it may be necessary for the technician to re-position the needle in the vein; this is better accomplished with a sharp needle than a blunt one. Upon subsequent withdrawal of thecollection tube 56 a fromshell 38, transmittingsleeve 44 will move according to the bias ofspring 54 in the direction ofarrows 58. The operation of themechanism 42 will, accordingly, moveactuator ferrule 50 in the opposite direction, towards its forward (upward), pre-filling position.Shuttle 24 will also move forward (upward, as sensed in the Figure) withferrule 50, under the impetus ofspring 54, so that the blunt end of the bluntingmember 26 a is extended beyond the tip ofneedle cannula 22, thus blunting the device.Shuttle 24 locks in the forward position with the bluntingmember 26 a extending beyond the puncture tip ofneedle cannula 22 beforeactuator ferrule 50 stops its forward movement. The additional forward movement ofactuator ferrule 50 relative toshuttle 24 allows the internal fillet or groove that previously unlocked the needle assembly to disengage from the locking detent. Accordingly,detent 28 can engage lockingnotch 16 a to lockneedle assembly 30 in the blunted configuration. The additional forward movement offerrule 50 also causesend cap 50 a to disengage fromshuttle flanges 32.Mechanism 42 comes to rest in the deployed configuration shown in FIG. 4B. Subsequent insertion of another collection tube will cause theactuator ferrule 50 to move rearward again, unlockingshuttle 24 and then engagingshuttle flanges 32 to return to the sharpened configuration shown in FIG. 4A, and removal of the tube thereafter will once again return the device to the blunted configuration of FIG. 4B. Thus, after the initial insertion of a sample tube,mechanism 42 serves to moveactuator ferrule 50 and the bluntingmember 26 a in a direction contrary to that of the sample tube and transmittingsleeve 44 in the holder shell. Such motion is illustrated as changes between the configurations of FIGS. 4A and 4B. - In an alternative embodiment,
actuator ferrule 50 may carry locking flanges disposed about the central aperture ofend cap 50 a (FIG. 2). Such locking flanges may be configured to engage shuttle flanges 32 (FIG. 1D) when the first insertion of a blood collection tube movesactuator ferrule 50 rearward from the initial configuration (FIG. 3) to the filling configuration shown in FIG. 4A. - In an alternative aspect of this invention, a mechanism in accordance with the present invention may incorporate a cam and follower arrangement instead of a rack and pinion arrangement. In such an embodiment, a rotating cylindrical cam (referred to herein as a “rotator”) will be disposed within the cylindrical body of the needle holder carrying the self-blunting needle assembly. An actuator structure (or “inner sleeve”) that engages the blunting member will follow the cam surface of the rotator. When the rotator rotates within the needle holder, the actuator follows by imposing a corresponding axial motion on the blunting member in accordance with the direction of rotation of the rotator. The device is configured so that the forward insertion of a sample tube into the needle holder rotates the rotator in a direction that causes the actuator to retract (rearward) within the needle holder. The rotating cam embodiment of the present invention, like the rack and pinion embodiment, creates contrary motion between the blunting member and the sample tube inserted into the holder with each insertion and withdrawal of a tube, except for the first time a collection tube is inserted into the holder. Such a device can employ the
safety needle assembly 30 of FIG. 1B, as described below. - FIGS. 5A, 5B and5C provide related views of a cylindrical cam or “rotator” 100 for use in one embodiment of the present invention. In the plan view of FIG. 5A,
rotator 100 is seen to have a round periphery, thus allowing for coaxial rotation within a cylindrical needle holder.Rotator 100 has three principal concentric annular segments: at least one followingsurface 102, at least onedriving surface 104 and acentral collet 106. Followingsurfaces 102 are disposed in the circumferential, outermost annular segment ofrotator 100, which includes a flatupper surface 102 a and a flatlower surface 102 b. Drivingsurfaces 104 are concentrically contiguous with followingsurfaces 102. Proceeding radially inward, the next annular segment ofrotator 100 iscollet 106, which is physically connected tosurfaces bridge 108.Bridge 108 spans a region betweencollet 106 and drivingsurfaces 104 that is occupied principally by acurvate gap 110. Theinterior region 112 ofcollet 106 defines arecess 114 within which is disposed an unlockingfillet 114 a. Fillet 114 a is better viewed in FIG. 5B, which also shows that the followingsurfaces 102 occupy a first annular region R1 and drivingsurfaces 104 occupy the contiguous annular region R2. - As is evident from FIG. 5C,
rotator 100 can be disposed within the generallycylindrical shell 138 of a needle holder, rotatably resting on thebottom shoulder 138 a ofshell 138. So disposed, the impingement of an axial force as indicated, e.g., byarrow 152 a, on followingsurface 102 will causerotator 100 to rotate in the direction ofarrow 152 b. If the structure imposing the force atarrow 152 a is not permitted rotational movement as it bears onsurface 102, it will move downward (axially) asrotator 100 rotates. Since drivingsurfaces 104 slope in a helical direction opposite from that of followingsurfaces 102, a structure that is slidably disposed onsurface 104 and that is constrained against rotation will move upward on the contrary incline of drivingsurface 104 as the structure onsurface 102 moves downward, as will be discussed further below. - A force transmitter and cam follower/actuator that bear on
surfaces rotator 100, are shown in an exploded coaxial relationship in FIG. 6.Transmitter 120 has a generally cylindrical configuration dimensioned to have the same outer diameter asrotator 100 so that the two can fit snugly in the same cylindrical needle holder shell. However,transmitter 120 also comprises guiding means for engaging the interior surface of the shell so thattransmitter 120 will be inhibited against free rotational motion within the shell. Preferably, it will be constrained for axial motion within the shell. In the embodiment of FIG. 6, the guiding means oftransmitter 120 comprises a pair of peripheral guidingfillets 122 that are dimensioned and configured to be slidably received within axially-extending grooves in the interior wall of the shell within whichtransmitter 120 is disposed. With thefillets 122 disposed in such grooves,transmitter 120 will be able to move axially, i.e., longitudinally, within the holder shell, but will not be able to rotate therein.Transmitter 120 comprises a pair of drivingsurfaces 124 that are dimensioned and configured to engage followingsurfaces 102 ofrotator 100 in annular region R1, within which they define a cylindrical receiving region C. - Also shown in FIG. 6 is actuator130 which has a cylindrical outer configuration having a diameter D dimensioned to be received within receiving region C of
transmitter 120.Actuator 130 has acentral aperture 132 into which lockingtabs shuttle flanges 32 of needle assembly 30 (FIG. 1B).Actuator 130 defines a pair of followingsurfaces 136 that are dimensioned and configured for complementary engagement with drivingsurfaces 104 in annular region R2 ofrotator 100. However,actuator 130 is constrained against rotational movement by the engagement ofinternal lugs 139 with a pair of posts (not shown) that extend upward frombottom shoulder 138 a ofshell 138 and which protrude throughrotator 100 viagap 110. - FIG. 7A provides a perspective view of a sample tube holder that may house a mechanism comprising the
rotator 100,transmitter 120 andactuator 130 of FIGS. 5A, 5B, 5C and FIG. 6. The holder comprises ashell 138 having a longitudinal axis A and ashoulder 138 a at its forward end.Shell 138 defines a pair of internally, axially disposedgrooves 122 a, shown in dotted outline. FIG. 7B provides an end view ofshell 138, showingaperture 138 b which is dimensioned and configured to receivesafety needle assembly 30 of FIG. 1D.Aperture 138 b is substantially circumscribed by aflange 138 c that is dimensioned and configured to permit the blunting component and rearward portion of the needle hub therein, but to engage hub flanges 18 (FIG. 1D), leaving thefirst end 12 a ofneedle hub 12 extending forward fromshoulder 138 a.Notch 138 e is configured to receive a locking spline 20 (FIG. 1D), and notch 138 f is dimensioned and configured to allow the detent 28 (FIGS. 1C and 1D) to pass throughaperture 138 b to avoid unlocking the needle assembly as it is first being inserted intoshell 138. After insertion of the needle assembly into the aperture, the needle assembly is rotated so that the locking spline andflanges 18 engageflange 138 c. Also seen in FIG. 7B are twoposts 138 g that extend axially fromshoulder 138 a towards the rearward end ofshell 138. - FIGS. 8A and 8B are cross-sectional schematic drawings that indicate the relative positions of the
transmitter 120,rotator 100 andactuator 130 in two different configurations withinshell 138. FIG. 8A depicts the holder mechanism in the deployed configuration. In this configuration,rotator 100 is rotatably situated withinshell 138 and, because it is resting onshoulder 138 a, it is constrained against forward axial movement. Thetransmitter 120 is disposed inshell 138 so that the lower (as sensed in FIG. 8A) portions of its helical driving surfaces 124 engage the upper portions of the followingsurfaces 102 ofrotator 100.Transmitter 120 carriesfillets 122 that engagegrooves 122 a inshell 138 and thus permit axial sliding motion oftransmitter 120 inshell 138 but prevent rotational motion.Actuator 130 is disposed within the outermost annular region ofrotator 100, with followingsurfaces 136 engaging driving surfaces 104. Aninternal post 138 g extending fromshell 138 through gap 110 (FIG. 5B) engageslug 139 to prevent actuator 130 from rotating withinshell 138. Aspring 154 is disposed axially betweentransmitter 120 andactuator 130. - When a forward (downward, as sensed in the Figure) force is imposed on bearing
surface 120 a oftransmitter 120, e.g., by pressing a sample collection tube intoshell 138,transmitter 120 moves downward, as indicated byarrow 156 a and the spiraled drivingsurface 124 bears upon the complementary followingsurface 102 ofrotator 100. Sincetransmitter 120 is con-strained against rotation,transmitter 120 acts as a driving cam follower and the downward motion oftransmitter 120 causesrotator 100 to rotate withinshell 138. Such rotation ofrotator 100 will cause drivingsurface 104 to impose a force upon followingsurface 136 ofactuator 130. Sinceactuator 130 is constrained against rotational motion by the engagement oflugs 139 with theposts 138 g extending upward fromshoulder 138 a, the force imposed by drivingsurface 104 will cause actuator 130 to move upwards (as indicated by arrow 156 b). Thus,rotator 100 serves as a linking member that movesactuator 130 in a direction opposite from that oftransmitter 120. The result of the downward axial motion oftransmitter 120 is the retracted configuration depicted in FIG. 8B, which showsrotator 100 in a rotated position andactuator 130 in an elevated position relative to FIG. 8A. - As
transmitter 120 andactuator 130 move towards each other from the pre-filling configuration of FIG. 8A to the filling configuration of FIG. 8B, they compressspring 154. The friction fit of a collection tube inshell 138 is sufficient to withstand the tendency ofspring 154 to decompress and move transmitter 120 (and the collection tube pressing against it) upward. However, upon manual removal of the collection tube,spring 154 will drivetransmitter 120 upward so that it remains in contact with the collection tube until it encounters a stop lug on the interior wall ofshell 138, e.g., lug 122 b ingroove 122 a. During the withdrawal process, the upward motion oftransmitter 120 will tend to disengage drivingsurface 124 from followingsurface 120. However, the residual downward force imposed byspring 154 onactuator 130 will cause followingsurface 136 to bear on drivingsurface 104, to whichrotator 100 will respond by rotatingsleeve 138 until followingsurface 102 again engages drivingsurface 124. Further withdrawal of the collection tube will allowspring 154 to drivetransmitter 120 still higher andactuator 130 still lower inshell 138, thus imposing further rotation onrotator 100 until the configuration of FIG. 8A is regained. - As with the rack and pinion embodiment of FIGS. 1 through 4B, the
needle assembly 30 is first inserted into theshell 138 in the sharpened configuration (shown in FIG. 1D) withmechanism 142 in the deployed configuration of FIG. 8A. Asneedle assembly 30 is inserted intoaperture 138 b, detent 28 (FIG. 1D) passes throughnotch 138 f (FIG. 7B) ofshell 138, and then alongsidefillet 114 a (FIG. 5B). Locking spline 20 (FIG. 1D) passes throughnotch 138 e (FIG. 7B), and hub flanges 18 (FIG. 1D) come to a stop againstflange 138 c (FIGS. 7B, 8A). The needle assembly is rotated to engageflange 138 c betweenspline 20 andflanges 18, thus locking the needle in the holder. This rotation disposesdetent 28 besidefillet 114 a. Meanwhile, theshuttle flanges 32 bear against lockingtabs 134 a ofactuator 130, pushingactuator 130 upward (as sensed in FIG. 8A) and lifting it offrotator 100 to the position shown in FIG. 8C. The rotation ofneedle assembly 30 that engagesflange 138 c also positions shuttle flanges 32 (FIG. 1B, 1D) between lockingtabs Transmitter 120 androtator 100 are in a deployed configuration, butactuator 130 is retracted and the needle assembly is sharp. - When the first sample tube is inserted into
holder shell 138, it bears ontransmitter 120, which moves downward, causingrotator 100 to rotate. This makesfillet 114 aswipe surface 28 a (FIG. 1C) ondetent 28 and unlock the needle assembly.Shuttle 24 then allowsactuator 130 to move forward (downward as sensed in FIG. 8A), but only until its followingsurface 136 engages drivingsurface 104 ofrotator 100. The apparatus is configured so that this occurs before the blunting member blunts the needle. The continued rotation ofrotator 100 in response to the further insertion of the sample tube then movesactuator 130 back upwards. At the point of full insertion of the sample tube, the device reaches the retracted configuration of FIG. 8B, in whichtabs 134 b ofactuator 130 hold shuttle 24 (not shown) in the retracted position, leaving the needle assembly in the sharpened configuration. Upon withdrawal of the sample tube,spring 154 drives the device back to the deployed configuration of FIG. 8A, andactuator 130 advances shuttle 24 forward, blunting the needle. Insertion of yet another collection tube will bring the device back to the sharpened configuration of FIG. 8E. - In accordance with another embodiment of the invention, the transmitter may be dimensioned and configured to engage the sample collection tube. For example, a
transmitter 120′ shown in FIG. 8D has a generally cylindrical configuration that defines a cylindrical receiving region C and drivingsurfaces 124 corresponding to those of transmitter 120 (FIG. 6). In addition, however,transmitter 120′ comprises a receivingferrule 120 b that extends axially from bearingsurface 120 a in a direction opposite from drivingsurfaces 124. Receivingferrule 120 b defines an interior region that is dimensioned and configured to receive the seal cap on a conventional sample blood collection tube. In addition, receivingferrule 120 b carries a leaf spring 120 e which may optionally be formed integrally therewith as shown in the Figure.Leaf spring 120 c protrudes into the interior region of receivingferrule 120 b and it is configured so that it will be displaced by a sample collection tube inserted therein. As suggested in FIG. 8E, a collection tube such asblood collection tube 56 a, which carries aseal cap 56 b, may be inserted into thecylindrical shell 138 and thus into the receivingferrule 120 b oftransmitter 120′ therein. As this occurs,seal cap 56 b will displaceleaf spring 120 c outwardly.Leaf spring 120 c is configured so that such displacement causes it to bear against the interior of the holder shell, thus increasing the friction betweentransmitter 120′ and the surroundingshell 138. This added friction helps keeptube 56 a in place during the filling process despite the bias ofspring 154. - The embodiment of FIG. 9A provides a schematic illustration of a lever-based mechanism for the present invention.
Mechanism 242 makes use of aring lever 210, shown in plan view in FIG. 9B and in perspective view in FIG. 9C.Ring lever 210 is configured in the shape of a ring having a pair offulcrum studs 212 extending outwardly and coaxially therefrom.Studs 212 define the fulcrum oflever ring 210 anddivide ring 210 into two roughlysemicircular arms arm 212 a extends upward (or forward) and comprises apintle 218 a for connecting to theactuator 230 in a hinge-like manner that permitspintle 218 a to move radially so thatring lever 210 can pivot.Arm 212 b extends downward (rearward) and comprises a bearingportion 218 b for engaging thetransmitter baffle 220 in a manner that allows movement corresponding to that ofpintle 218 a onactuator frame 230. The central region 216 (FIG. 9B) ofring 210 is configured to allow the blunting member and associated shuttle to pass therethrough. - When
ring lever 210 is mounted bystuds 212 for rotation about their axis, a force applied to a non-axial point onring 210, as indicated by the application of force F1 at a point diametrically opposite frompintle 218 a, will produce a rotation aboutstuds 212. As sensed in FIG. 9C, an upward motion of bearingportion 218 b resulting from an upwardly-directed force F1 will produce a contrary, downward motion ofpintle 218 a, as indicated by arrow F2.Lever ring 210 thus operates as a lever of the first class (one in which the fulcrum is between the applied force and the load). - In accordance with this aspect of the invention,
ring lever 210 is mounted insideholder shell 238 withstuds 212 rotatably disposed at right angles to the longitudinal axis of the shell.Pintle 218 a is connected to anactuator frame 230 by engaging a lift arm 230 a connected thereto. Atransmitter baffle 220 is mounted withinshell 238 for axial sliding motion between a stop member 238 a onshell 238 andframe 230.Transmitter baffle 220 defines a large internal aperture (not shown) to permit the filling needle at the rearward end of the blunting member, and the bluntingmember shuttle 24 to pass therethrough. Aspring 54 is partially compressed betweenshuttle flanges 32 andbaffle 220. -
Actuator frame 230 is slidably disposed withinshell 238. It will be apparent that the insertion of a sample collection tube that is pressed againsttransmitter baffle 220 will apply a force on bearingportion 218 b ofring lever 210 at an end thereof opposite frompintle 218 a, corresponding to force F1 (FIG. 9C).Ring lever 210 will rotate aboutstuds 212 causing pintle 218 a to move in the contrary direction indicated by arrow F2 (FIG. 9C). Sincepintle 218 a engages theslidable actuator frame 230, the upward (as sensed in FIG. 9A) movement ofbaffle 220 produces a contrary, downward motion offrame 230. -
Actuator frame 230 is configured similarly toactuator ferrule 50 of mechanism 42 (FIG. 3) insofar as it permits the initial installation ofneedle assembly 30 inshell 238 in the sharp configuration while the mechanism remains in the pre-filling configuration of FIG. 9A. However, the internal configuration ofactuator frame 230 will cause it to releasedetent 28 when it moves rearward (downward as sensed in FIG. 9A) in response to the first insertion of a sample tube intoshell 238. Then, the needle is sharp while the device is in the filling configuration. Upon the subsequent removal of the sample collection tube,spring 54 will push shuttle 24 (and theactuator frame 230 bearing thereon) upward, thus moving the mechanism to the deployed configuration and the needle assembly (not fully shown) to the blunted configuration. The subsequent insertion of another sample tube will move baffle 220 upward and the resulting action ofring lever 210 will pullactuator frame 230 andshuttle 24 resting thereon downward in a direction contrary to the direction of insertion of the sample collection tube, moving the mechanism to the retracted configuration and the needle assembly to the sharpened configuration. - In a related lever-type embodiment shown in FIG. 9D,
mechanism 242′ comprises atransmitter baffle 220′, aring lever 210′ and anactuator 230′ that are integrally interconnected byhinge straps 218 a′ and 218 b′ that are secured thereto. As shown in FIG. 9D,mechanism 242 may be considered a single piece. Hinge straps 218 a′, 218 b′ are sufficiently pliable to allow the necessary movement betweenlever 210′ and drawtransmitter baffle 220′ andactuator 230′ aslever 210′ pivots to drawbaffle 220′ andactuator 230′ towards each other and then push them apart. Strap hinges 218 a′ and 218 b′ may be formed, for example, from a polymeric material. Optionally,transmitter baffle 220′ and/oractuator 230′ may be formed from the same material as the hinge strap connected thereto and they may be molded together with the hinge strap in a single operation, leaving a distal end of the hinge strap free to be secured to another structure ofmechanism 242′. For example, lever 210′ may be formed withhinge straps 218 a′ and 218 b′ extending therefrom, and the distal ends of the straps may be secured to baffle 220′ andactuator 230′ by any suitable method, e.g., by adhesive, sonic welding, etc. Alternatively,mechanism 242′ might be formed as a whole in a single molding operation. - According to yet another embodiment of the invention, a
mechanism 342 shown in FIG. 10A comprises pliable,resilient straps 310 connecting a transmittingsleeve 320 and anactuator ferrule 350.Straps 310 are configured to have a reverse bend aboutpins 348, and so extend forward from the forward edge of transmittingsleeve 320, around pins 348 toactuator ferrule 350, from which it extends forward as well. In the region of the reverse bend around pins 348,straps 310 may slidably bear against the interior offorward end 36 a ofholder 36. FIG. 10A shows the device in a blunted configuration corresponding to the configuration shown in FIG. 4B. When a collection tube is inserted intoholder 36, transmittingsleeve 320 is moved forward inholder 36, pushingstraps 310 against theforward end 36 a ofholder 36.Straps 310 loop around pins 348 and pushactuator ferrule 350 rearward, unlockingneedle assembly 30 and pullingshuttle 24 to a retracted position as shown in FIG. 10B, placing the device in a sharpened configuration. Thus, straps 310 constitute a reversing link between the transmittingsleeve 320 and theactuator ferrule 350, performing an equivalent function to the gear and toothed splines of the embodiment of FIG. 3. - In each of the foregoing embodiments, the transmitter is movable axially, i.e., longitudinally, in the shell, and it is not fastened to the shell. According to other embodiments of this invention, however, the transmitter device may move directly or indirectly to and fro relative to the central axis of the shell, thus moving obliquely relative to the motion of a sample collection tube being inserted into, or withdrawn from, the shell. Such radial motion is also oblique relative to the axial forward and rearward motions of the actuator. In contrast to previously described embodiments, the transmitter device may optionally be fastened to the shell, since no substantial axial movement is required of it. In such embodiments, the transmitter device may comprise at least one, preferably at least two, resilient arms secured to the interior of the holder. The transmitter device, i.e., one or more transmitter arms, is configured so that when a collection tube is inserted into the holder, the tube bears against it and presses it sideways towards the shell of the holder. Thus, the transmitter device moves obliquely relative to the collection tube. A linkage between the transmitter device and the actuator, such as a cam and follower engagement between them, converts the oblique (sideways) motion of the transmitter device into forward or rearward motion of the actuator. Thus, the transmitter device moves obliquely relative to the actuator. As with the previously described embodiments, the motion of the actuator (and of the blunting member, when one is secured thereto) is opposite to that of the sample collection tube. One example of such an embodiment is shown in the accompanying FIG. 11, in which a
blood collection needle 455 comprises aholder 436 in accordance with the present invention.Holder 436 comprises acylindrical shell 438 which has afront end 436 a and aback end 436 b and amechanism 442 therein, described below. Atfront end 436 a,shell 438 defines aneedle hub 410 in which aneedle cannula 422 is mounted.Back end 436 b andshell 438 are dimensioned and configured to receive a sample collection tube therein. - In a
blunting mechanism 442, the transmitter device comprises a set of resilient transmittingarms 444 a which are mounted in the interior ofshell 438 and which extend forwardly in the interior of the shell. Transmittingarms 444 a also extend towards the central axis of the shell so that when a sample collection tube is inserted in the back end ofholder 436, it bears against transmittingarms 444 a. Transmittingarms 444 a, being flexible and resilient, are displaced from the central region ofshell 438 towards the wall of the shell as the sample collection tube moves forward inholder 436, and transmittingarms 444 a move inwardly as the sample collection tube is withdrawn, i.e., the arms move obliquely (i.e., radially) relative to the generally axial motion of the sample collection tube. In the illustrated embodiment, transmittingarms 444 a are fastened to the shell near the back end of the shell and extend forwardly therein (in other embodiments, they might extend rearwardly from the front). Each of transmittingarms 444 a carries a wedge 446 a which points outwardly, towardsshell 438, and each wedge has a cam surface S. -
Blunting mechanism 442 also comprises a ferrule-shapedactuator 450 disposed withinshell 438.Actuator 450 is dimensioned and configured to receive therein the transmittingarms 444 a.Actuator 450 comprises acannula hub 451 which engages asecond cannula 426 which extends forwardly therefrom and is disposed concentrically withinneedle cannula 422. The forward-extending portion ofcannula 426 terminates with a blunt end and constitutes the bluntingmember 426 a of the device.Cannula 426 also extends rearward, terminating at a sharp end for puncturing the seal on a sample collection tube and for providing a conduit for fluid flow between the sample collection tube inholder 436 andneedle cannula 422. The sharp end ofcannula 426 is covered with a self-resealingboot 427 which blocks fluid flow from the tip end ofcannula 426 until the boot is displaced by a collection tube. The boot re-sealscannula 426 when the collection tube is removed, as is known in the art.Cannula 426 is secured to actuator 450 so that it moves withactuator 450. Aspiral spring 454 is positioned withinshell 438 to urge actuator 450 forward and serves as a biasing member in this embodiment. Other biasing members, e.g., other types of springs, an elastic band, etc., may be used as a biasing means in place ofspring 454. Since the annular portion ofactuator 450 extends rearward fromhub 451, it is configured to seat the end of a sample collection tube and permit the blunting cannula to perforate the seal on the collection tube. -
Needle cannula 422,second cannula 426,actuator 450,transmitter arms 444 a andshell 438 are dimensioned and configured so that whenactuator 450 is in its forward-most position withinshell 438, bluntingmember 426 a extends beyond the sharp tip ofneedle cannula 422, thus blunting the device, Le., the device is in a blunted configuration. They are further configured so that whenactuator 450 is moved rearward under the operation ofmechanism 442, the blunt end of bluntingmember 426 a is withdrawn intoneedle cannula 426, thus exposing the sharp tip of the needle and placing the device in a sharpened configuration, as follows.Actuator 450 is equipped withwedge apertures 452.Arms 444 a and wedges 446 a are configured so that when a sample tube is inserted intoholder 436, the tube bears againstarms 444 a, pushing them outward so that surfaces S engage the rearward interior edge ofwedge apertures 452. As the sample collection tube movesarms 444 a still farther apart from one another, wedges 446 a are driven farther outward andactuator 450 rides along surfaces S and is thus moved backward in the device. Thus, surfaces S serve as cam surfaces andactuator 450 serves as a cam follower. In this embodiment,arms 444 a are configured so that the sample collectiontube contacts arms 444 a at a point between their connection to shell 438 and their linkage toactuator 450. Thearms 444 a flex about their points of attachment to shell 438, which serve as their fulcrums. It may be noted that thearms 444 a move in response to a force applied by the sample tube between the fulcrum and the load (actuator 450), soarms 444 a act as levers of the third class. If necessary,shell 438 may compriseshell apertures 438 a to accommodate the protrusion of wedges 446 a entirely throughwedge apertures 452. When actuator 450 begins in its forwardmost position (the blunting position) and is then moved rearward byarms 444 a and wedges 446 a, bluntingmember 426 a is withdrawn from its blunting position towards a position within needle cannula 422 (the sharpened position), thus sharpening the device.Arms 444 a may be configured to causeactuator 450 to fully withdraw bluntingmember 426 a intoneedle cannula 422, which is typically achieved with a travel of about 0.2 inch. Upon withdrawal of the sample collection tube from the holder, the resilience ofarms 444 a causes them to return towards the central region inshell 438, and surfaces S then permitactuator 450 to advance under the impetus ofspring 454. In an alternative embodiment, a positive motion cam may be established betweenarms 444 a andactuator 450 and the spring-like arms 444 a may comprise the biasing means due to their resiliency to advance theactuator 450 whenarms 444 a resume their inwardly-disposed configuration. - In another embodiment of the invention, the full withdrawal of blunting
member 426 a is accomplished in a staged manner by a plurality of sets of wedges. In such an embodiment, aholder 436, shown in FIGS. 12A, 12B and 12C, comprises a transmitter device comprising a first set ofarms 444 b withwedges 446 b which may be configured to withdraw theactuator 450′ and a blunting member (not shown) only part way, e.g., 0.1 inch. The transmitter device further comprises a second set ofarms 444 c andwedges 446 c, and anactuator 450′ and shell 438′ which comprise apertures to accommodate both sets of wedges in a manner similar to that shown in FIG. 11. In such an embodiment, however, the second set ofwedges 446 c may be situated at a different point on the front-to-back length ofshell 438 than the first set ofwedges 446 b. Thus, the mechanical action of the two sets of wedges is staggered. Each set may separately accomplish a part, e.g., approximately half, of the withdrawal motion to move bluntingmember 426 a from its extended, blunting position to its withdrawn, sharpened position, over different (although possibly overlapping) time intervals from the other set of wedges as the sample collection tube is inserted into the holder. Thus,arms 444 b inshell 438′ are configured for the first contact with a sample collection tube andwedges 446 b thereon are configured to effect a first portion of the rearward motion ofactuator 450′ by engaging apertures 438 b.Arms 444 c are configured for contact with the sample collection tube afterarms 444 b, andwedges 446 c thereon are configured to effect the completion of the rearward motion ofactuator 450′ by engaging apertures 438 c to sharpen the device. FIG. 12C provides an end view in which both sets ofarms - To provide a blood collection device of the present invention in an initially sharpened state prior to the first insertion of a sample collection tube, the transmitter arms can be extended beyond the wedges to include locking detents to retain the actuator in the withdrawn position prior to the first insertion of a sample collection tube into the device. For example,
holder 436″ of FIG. 13A comprises arms 444 d which carrywedges 446 d for engagingwedge apertures 452 e. Arms 444 d carry lockingextensions 444 e which terminate in lockingdetents 446 b.Actuator 450″ is provided with corresponding lockingapertures 450 f configured so that whenactuator 450″ is in an initial, rearward position, lockingtabs 446 b engage the front surface ofactuator 450″ via lockingapertures 450 f, as seen in FIG. 13B. Thus, the device may be disposed in an initial sharpened configuration even without a sample collection tube therein. Lockingapertures 450 f are dimensioned to permit arms 444 d to move outwardly (i.e., radially relative to the central axis ofshell 438, with which cannula 426 is aligned) and thus disengagetabs 446 b from the actuator.Arms 444 a are configured so that upon the initial insertion of a sample collection tube intoshell 438, the arms are moved apart sufficiently to disengage lockingtabs 446 b fromactuator 450″ as indicated byarrows 453.Actuator 450″ is then free to move forward under the pressure of a spring (not shown) like spring 454 (FIG. 11). As the sample tube is inserted further, however, the mechanism in the holder causesactuator 450″ to move rearward again. The sample tube spreads arms 444 d so that they pass throughapertures 450 f asactuator 450″ moves rearward to a retracted position to sharpen the device. When the sample tube is withdrawn,actuator 450″ moves forward, but the sample tube preventstabs 446 b from engaging the notches inapertures 450 f Instead, actuator 450″ moves forward beyond the notches and beyond the ends ofextensions 444 e. Finally, arms 444 can move towards the center of the device andactuator 450″ is fully advanced so that the blunting member blunts the needle cannula. The ends of arms 444 can then move toward the center of the shell into position to bear against the central portion of the actuator, as shown in FIG. 13C, and preventactuator 450″ from moving rearward, thus locking the device in the blunted configuration. When another sample collection tube is inserted into the device,arm extensions 444 e will be driven outward so that they align withapertures 450 f and they will thus permit the mechanism to move the blunting member rearward to sharpen the device. It will therefore be understood thattabs 446 b only holdactuator 450″ in the forward position in an initial configuration prior to the first insertion of a sample collection tube into the needle. - In use, a blood collection
needle comprising holder 436″ is initially provided in an initial sharpened configuration in which actuator 450″ and a second (blunting) cannula (not shown) are withdrawn to the sharpened position andactuator 450″ is engaged by lockingtabs 446 b (FIGS. 13A and 13B). In this initial sharpened configuration, the user can effect venipuncture with the needle cannula (not shown) inhub 410 and with the cannula boot (not shown) preventing fluid flow. Then, upon the initial insertion of a sample collection tube intoholder 436″, arms 444 d move apart sufficiently to disengage lockingtabs 446 b fromactuator 450″ (as suggested by arrows 453). A spring (not shown) then urgesactuator 450″ forward, temporarily blunting the device. Upon further insertion of the sample collection tube, the cam surfaces S ofwedges 446 d engageapertures 452 e, thus moving actuator 450″ and the blunting member secured thereto rearward so that the needle is sharpened as the sample collection tube is fully inserted into the device. At the same time, theboot 427 is pushed past the sharp end ofcannula 426 as the cannula pierces the seal on the collection tube to allow fluid flow into the tube.Actuator 450″ is not retained in this position by lockingtabs 446 b because arms 444 d are held apart by the sample tube and so cannot engage lockingapertures 450 Therefore, upon removal of the sample collection tube,actuator 450″ moves forward again to the blunting position as wedges 446 a withdraw fromapertures 450 f By the time the sample collection tube is withdrawn, arms 444 d have been withdrawn fromapertures 450 f and they are behind the central portion ofactuator 450″, locking the device in the blunted configuration until another sample collection tube is inserted into the device. - Still another embodiment in accordance with the present invention is shown in FIGS. 14A through 15. In this embodiment, the transmitter device comprises two transmitter arms, each attached to one side of the interior of the holder and extending towards the other side. The transmitter arms terminate in lugs which ride on cam surfaces formed on the actuator. When a collection tube is inserted into the holder, the traversing sections of the transmitter arms are moved by the collection tube so that the lugs bear on the cam surfaces, thus moving the actuator. In particular, FIG. 14A shows a
holder 536 for a blood collection needle comprising ashell 538 which has a generally cylindrical configuration with afront end 538 a in which is formed aneedle aperture 540 within which the needle may be mounted. Optionally,needle aperture 540 may be configured in the same manner as the mounting portion 14 a of needle hub 10 (FIG. 1A), which has funnel-like insertion regions to facilitate the insertion of the needle therein and of the blunting member into the needle cannula. At theback end 538 b,shell 538 comprises afinger flange 538 c for the convenience of the user. Withinshell 538,mechanism 542 effects rearward motion of a blunting member (to sharpen the device) in response to the insertion of a sample collection tube in the device.Mechanism 542 comprisestransmitter arms actuator 550 andspring 554.Transmitter arm 546 b is attached to shell 538 at the back end thereof and extends in a forward direction and generally traverses the central, interior portion of the shell (from left to right as sensed in FIG. 14A) to terminate atlug 548 b.Transmitter arm 546 a is configured similarly toarm 546 b, but it is attached on the shell at a point generally opposite from wherearm 546 b is attached and it traverses the central portion ofshell 538 in the opposite direction, as suggested in FIG. 14A.Actuator 550 carries a mounting lug in which a mountingaperture 524 is formed for receiving a blunting member.Actuator 550 also carrieswedges cam surface cam surface 552 a andlug 548 b is positioned to bear againstcam surface 552 b. In the configuration shown in FIGS. 14A and 14B,actuator 550 is in the forwardmost position under the bias ofspring 554, withlugs arms shell 538, they also extend in planes that are generally parallel to one another. In the view of FIG. 14B,cam surface 552 a is sloping downward into the foreground of the FIG. butcam surface 552 b faces away from the viewer and is not visible in that Figure. By comparing the views of FIGS. 14B and 14C, it will be understood thatactuator 550 defines a pair of generallyparallel slots aperture 524 and thatwedges Slots arms lugs 548 a to rest oncam surface 552 a andlug 548 b to rest oncam surface 552 b. The comparison of these FIGS. will also make clear that in the view of FIGS. 14B and 14C,cam surface 552 b is inclined away from the viewer, and so is not visible in these Figures. - Referring again to FIG. 14a, it can be understood that when a sample collection tube is inserted into
holder 536, it will bear against the mid-portions oftransmitter arms arms actuator 550, and bend them towards the sides ofshell 538 to which they are attached.Lugs spring 554. The result of such an arrangement is shown in FIG. 15, in which the insertion ofsample collection tube 56 a has substantially straightenedtransmitter arms shell 538.Lugs actuator 550 rearward, thus compressingspring 554. The bluntingmember 26 a carried onactuator 550 is moved rearward in the device to the blunting configuration, leaving the tip ofneedle 26 exposed. Withdrawal ofcollection tube 56 a will permitarms spring 554 to move actuator 550 forward, advancing bluntingmember 26 a so that it protrudes fromneedle 22, thus blunting the device. - Optionally, any of the embodiments of FIGS. 11-15 may easily be configured to receive a removable needle and blunting member assembly of the kind shown in U.S. Pat. No. 5,951,520, the disclosure of which is hereby incorporated herein by reference.
- While the invention has been described in detail with reference to particular embodiments thereof, it will be apparent that upon a reading and understanding of the foregoing, numerous alterations to the described embodiments will occur to those skilled in the art and it is intended to include such alterations within the scope of the appended claims.
Claims (9)
1. A bluntable blood collection needle comprising:
a needle cannula comprising a forward puncture tip, a rearward end, and a needle passageway therethrough;
a blunting member comprising a forward blunt tip and a rearward tip, wherein
the blunting member is received telescopically within the needle passageway with the forward tips pointed in the same direction, and
the blunting member is movable between an insertion configuration, in which the puncture tip of the needle cannula is exposed, and a blunted configuration, in which the blunt tip of the blunting member extends beyond the puncture tip of the needle cannula;
a needle hub comprising a forward end, a rearward end, a hub passageway extending therethrough forming a shuttle portion and a wall, and a forward locking notch and a rearward locking notch through the wall, wherein the needle cannula extends from the forward end of the needle hub;
a blunting member shuttle comprising a forward end, a rearward end, an axial passageway, a detent mounted on a resilient arm, and a shuttle flange, wherein
the blunting member shuttle is slidably received within the shuttle portion of the hub passageway,
the blunting member is mounted on the blunting member shuttle,
the detent is dimensioned and configured to engage and to protrude through, and is movable between the forward locking notch and the rearward locking notch, and comprises an obliquely disposed protruding surface, and
the blunting member is in the insertion configuration when the detent is engaged in the rearward locking notch, and in the blunted configuration when the detent is engaged in the forward locking notch.
2. The blood collection needle of claim 1 , wherein the blunting member extends rearwardly from the blunting member shuttle and the proximal tip is a sharp end.
3. The blood collection needle of claim 1 , wherein the rearward end of the blunting member shuttle further comprises a boot barb and a self-sealing boot mounted thereon.
4. The blood collection needle of claim 1 , wherein the forward end of the hub passageway defines a proximal insertion region that converges rearwardly from the forward end of the needle hub, thereby facilitating the insertion of the rearward end of the needle cannula into the hub passageway.
5. The blood collection needle of claim 1 , wherein forward end of the shuttle portion of the hub passageway defines a second insertion region that converges forwardly toward the forward end of the needle hub, thereby facilitating the insertion of the blunting member into the passageway of the needle cannula.
6. The blood collection needle of claim 5 , wherein the second insertion region converges to a diameter larger than the diameter of the blunting member and smaller than the diameter of the needle passageway, and is aligned therewith, thereby forming a stop for the rearward end of the needle cannula.
7. The blood collection needle of claim 1 , wherein wall of the needle hub further comprises a channel extending between the forward notch and the rearward notch dimensioned and configured to permit the detent to slide therein when the blunting member is moved between the insertion configuration and the blunted configuration.
8. The blood collection needle of claim 1 , wherein the needle hub further comprises a locking flange and a locking spline.
9. The blood collection needle of claim 1 , wherein the shuttle flange is dimensioned and configured to engage a means for moving the blunting member between the insertion configuration and the blunted configuration.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/842,278 US20040254499A1 (en) | 1998-11-25 | 2004-05-10 | Holder for blood collection needle with blunting mechanism |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US09/199,742 US6146337A (en) | 1998-11-25 | 1998-11-25 | Holder for blood collection needle with blunting mechanism |
US09/649,773 US6733465B1 (en) | 1998-11-25 | 2000-08-29 | Holder for blood collection needle with blunting mechanism |
US10/842,278 US20040254499A1 (en) | 1998-11-25 | 2004-05-10 | Holder for blood collection needle with blunting mechanism |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US09/649,773 Continuation US6733465B1 (en) | 1998-11-25 | 2000-08-29 | Holder for blood collection needle with blunting mechanism |
Publications (1)
Publication Number | Publication Date |
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US20040254499A1 true US20040254499A1 (en) | 2004-12-16 |
Family
ID=22738832
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/199,742 Expired - Lifetime US6146337A (en) | 1998-11-25 | 1998-11-25 | Holder for blood collection needle with blunting mechanism |
US10/842,278 Abandoned US20040254499A1 (en) | 1998-11-25 | 2004-05-10 | Holder for blood collection needle with blunting mechanism |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/199,742 Expired - Lifetime US6146337A (en) | 1998-11-25 | 1998-11-25 | Holder for blood collection needle with blunting mechanism |
Country Status (4)
Country | Link |
---|---|
US (2) | US6146337A (en) |
EP (1) | EP1143853A4 (en) |
AU (1) | AU1745900A (en) |
WO (1) | WO2000032096A1 (en) |
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WO2007134347A3 (en) * | 2006-05-18 | 2008-02-07 | Greiner Bio One Gmbh | Receiving device for a medical apparatus |
US20090216154A1 (en) * | 2008-02-21 | 2009-08-27 | Bencha International Group. Inc | Automatically retractable safety blood sampler |
US20120323142A1 (en) * | 2011-05-31 | 2012-12-20 | Sta-Med Llc | Blood collection safety devices and methods of use and manufacture |
KR101372386B1 (en) | 2012-04-05 | 2014-03-12 | 연세대학교 산학협력단 | Needle holder for suturing micro surgical field |
US8747355B2 (en) | 2010-06-23 | 2014-06-10 | Sta-Med, Llc | Automatic-locking safety needle covers and methods of use and manufacture |
US10335554B2 (en) | 2008-06-02 | 2019-07-02 | Sta-Med, Llc | Needle cover |
US11845082B1 (en) * | 2021-03-25 | 2023-12-19 | Amazon Technologies, Inc. | Specimen tube |
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WO1998042393A1 (en) * | 1997-03-26 | 1998-10-01 | Bio-Plexus, Inc. | Parenteral fluid transfer apparatus |
US6146337A (en) * | 1998-11-25 | 2000-11-14 | Bio-Plexus, Inc. | Holder for blood collection needle with blunting mechanism |
US6733465B1 (en) * | 1998-11-25 | 2004-05-11 | Bio-Plexus, Inc. | Holder for blood collection needle with blunting mechanism |
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US6994213B2 (en) * | 2001-09-18 | 2006-02-07 | Becton, Dickinson And Company | Packaging for push button blood collection set |
US6855128B2 (en) * | 2001-09-25 | 2005-02-15 | Becton, Dickinson And Company | Dual blunting needle assembly |
US7399292B2 (en) * | 2001-09-25 | 2008-07-15 | Becton, Dickinson And Company | Activation of dual blunting needle assembly |
US6837872B2 (en) * | 2002-05-02 | 2005-01-04 | Becton, Dickinson And Company | Needle holder for use with safety needle assembly |
US20030208160A1 (en) * | 2002-05-02 | 2003-11-06 | Becton, Dickinson And Company | Needle assembly |
US6991608B2 (en) * | 2003-04-03 | 2006-01-31 | Becton, Dickinson And Company | Medical assembly |
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US20070123822A1 (en) * | 2005-11-25 | 2007-05-31 | Biotop Holding Co., Ltd. | Safety syringe for taking blood |
US20080009806A1 (en) * | 2006-07-10 | 2008-01-10 | Biotop Holding Co., Ltd. | Blood sampling device |
US20090089924A1 (en) * | 2007-10-06 | 2009-04-09 | Jonathan Jan | Spa tub apparatus |
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PT3099353T (en) * | 2014-01-30 | 2019-02-19 | Medical Injection Devices Inc | Medicament dispensing device |
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Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007134347A3 (en) * | 2006-05-18 | 2008-02-07 | Greiner Bio One Gmbh | Receiving device for a medical apparatus |
US20090216154A1 (en) * | 2008-02-21 | 2009-08-27 | Bencha International Group. Inc | Automatically retractable safety blood sampler |
US11090443B2 (en) | 2008-06-02 | 2021-08-17 | Sta-Med, Llc | Needle cover |
US10335554B2 (en) | 2008-06-02 | 2019-07-02 | Sta-Med, Llc | Needle cover |
US9694140B2 (en) | 2010-06-23 | 2017-07-04 | Sta-Med, Llc | Automatic-locking safety needle covers and methods of use and manufacture |
US10682470B2 (en) | 2010-06-23 | 2020-06-16 | Sta-Med, Llc | Automatic-locking safety needle covers and methods of use and manufacture |
US8747355B2 (en) | 2010-06-23 | 2014-06-10 | Sta-Med, Llc | Automatic-locking safety needle covers and methods of use and manufacture |
US8663129B2 (en) * | 2011-05-31 | 2014-03-04 | Sta-Med, Llc | Blood collection safety devices and methods of use and manufacture |
US9848810B2 (en) | 2011-05-31 | 2017-12-26 | Sta-Med, Llc | Blood collection safety devices and methods of use and manufacture |
US9445760B2 (en) | 2011-05-31 | 2016-09-20 | Sta-Med, Llc | Blood collection safety devices and methods of use and manufacture |
US20120323142A1 (en) * | 2011-05-31 | 2012-12-20 | Sta-Med Llc | Blood collection safety devices and methods of use and manufacture |
US11116432B2 (en) | 2011-05-31 | 2021-09-14 | Sta-Med, Llc | Blood collection safety devices and methods of use and manufacture |
KR101372386B1 (en) | 2012-04-05 | 2014-03-12 | 연세대학교 산학협력단 | Needle holder for suturing micro surgical field |
US11845082B1 (en) * | 2021-03-25 | 2023-12-19 | Amazon Technologies, Inc. | Specimen tube |
Also Published As
Publication number | Publication date |
---|---|
EP1143853A4 (en) | 2005-02-09 |
WO2000032096A1 (en) | 2000-06-08 |
EP1143853A1 (en) | 2001-10-17 |
US6146337A (en) | 2000-11-14 |
AU1745900A (en) | 2000-06-19 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |
|
AS | Assignment |
Owner name: ICU MEDICAL SALES, INC., CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BIO-PLEXUS MERGER CORP.;REEL/FRAME:019477/0033 Effective date: 20021113 |