HK1115735B - Winged needle with needle shield - Google Patents

Description

Winged needle with needle shield

Cross Reference to Related Applications

This application claims priority from the following provisional patent applications, and this application expressly includes these provisional patent applications by reference:

60/659226-Shield Apparatus for Locking onto a Needle-applied date 3, 7/2005;

60/659217-Needle shield Apparatus with Tubular Needle cover-applied for 3/7/2005;

60/659213-Needle Shield Apparatus with Tether to Needle hub-application date 3/7/2005;

60/714954-Blood Collection Device with Needle Shield-application date 9/7/2005.

Background

This patent application relates to medical devices for collecting blood or other bodily fluids or infusing fluids which use a needle to pierce a human or animal body. It includes means for shielding the needle.

Disclosure of Invention

One embodiment of the present invention is a winged needle device having a housing with at least one, and preferably two, outwardly extending wings. The fin member is fixed to the housing. The fin member is oriented generally radially outward relative to a longitudinal axis of the needle and is rotatable relative to the housing from a first non-shielding position to a second shielding position. The needle shield assembly is mounted relative to the housing such that the needle shield assembly is slidable longitudinally along the needle. When the fin member is rotated from the first non-shielding position to the second shielding position, the needle shield assembly is unlocked by the release mechanism and can slide along the needle shaft relative to the housing to shield the needle. In the first non-shielding position, the fin members are oriented from approximately perpendicular to approximately 60 degrees from vertical. The wings are movable and can be moved towards the fin members (either rotated or folded) when the fin members are in the first non-shielding position. A spring biases the needle shield assembly toward the second shielding position. The wings are rotatable relative to the housing to enable the wings to move toward the fin member when the fin member is in the first non-shielding position.

Drawings

FIG. 1 is an isometric view of a device incorporating the present invention prior to needle shield deployment (deployment);

FIG. 2 is an isometric view of a device incorporating the present invention after deployment of a needle shield;

FIG. 3 is a cross-sectional view of a device incorporating the present invention prior to deployment of a needle shield;

FIG. 4 is an isometric cross-sectional view of a device incorporating the present invention prior to deployment of a needle shield;

FIG. 5 is a cross-sectional side view of a device incorporating the present invention after deployment of a needle shield;

FIG. 6 is an isometric cross-sectional view of a device incorporating the present invention after deployment of a needle shield;

FIG. 7 is a side view of a device incorporating the present invention prior to deployment of a needle shield;

FIG. 8 is a cross-sectional view through section A-A in FIG. 7;

FIG. 9 is an isometric view of a portion of a needle shield actuator incorporating the device of the present invention;

fig. 10 is an isometric view of the distal end of a portion of a needle shield for use in a device incorporating the present invention.

Detailed Description

The following describes preferred embodiments of the present invention for use with a blood collection device. Similar structures may be used for infusing fluids. The purpose of the blood collection device 5 is to pierce a blood vessel (or other organ) with the needle 10 and withdraw blood (or other fluid) through the tube 15 into a container. The device uses techniques such as those described in U.S. provisional patent application nos. 60/659213, 60/659217, and 60/659226, all of which are incorporated herein by reference.

The preferred embodiment of the device consists of the following basic components:

a housing 20 having wings 225 and 230;

needle 10, needle 10 being secured to needle hub 50 and being in fluid communication with tube 15;

a needle shield assembly 110; and

an actuator assembly 30, the actuator assembly 30 having a rotatable fin 300.

Housing 20 has a generally cylindrical body 200, with the generally cylindrical body 200 having a distal end 205 and a proximal end 210. Distal end 205 has an opening 215. The proximal end 210 has an opening 220. A passageway 236 extends between the openings at the proximal and distal ends. Channel 236 is sized such that shield assembly 110 fits axially therein and shield assembly 110 is able to slide axially therealong. The housing 20 is provided with wings 225 and 230, which wings 225 and 230 are capable of bending upwards towards each other and towards the fins 300 on the actuator assembly 30. Fillet blocks 227 facilitate molding of wings 225 and 230 and housing 20. The same corner-fill block is provided to stabilize the wing 230. Wings 225 and 230 are provided with recessed portions 250 and 255, respectively. They are shaped and sized to receive fins 300. Housing body 200 is provided with a slot 260, slot 260 being designed to receive a key 190 (described below) on shield assembly 110. Slot 260 extends from proximal end 210 (at which proximal end 210 slot 260 opens) toward distal end 205 of housing body 200 (at which distal end 205 slot 260 closes). Slot 260 has a proximal end 265 and a distal end 270.

Needle hub 50 has a stepped distal end 550, with stepped distal end 550 forming a hollow open ended cylinder 555, with hollow open ended cylinder 555 mating with opening 215 in proximal end 210 of housing body 200. The step forms a flange 570. Stepped distal end 550 is provided with a slot 560 (see fig. 6), slot 560 being aligned with slot 260 and extending from flange 570 along post 555 to its open end. Slot 560 also receives key 190. The slot 560 is open at the front to allow the key 190 to move inside it, and the slot 560 is closed at the rear to prevent the key 190 from exiting it.

Proximal end 75 of needle 10 is glued into needle hub 50. Rear end 565 is a proximally extending open ended cylinder designed to mate with tube 15, thereby allowing fluid to flow through needle 10 and tube 15 and into a receptacle for collection.

The fin assembly 30 has a cylindrical body portion 350, the cylindrical body portion 350 having a proximal end 365 and a distal end 360. Proximal end 365 and distal end 360 are provided with openings 366 and 367, respectively. A passage 370 extends between the proximal and distal ends. The passage 370 has an inner surface 372. Fin assembly 30 fits concentrically over cylindrical body 200 and is capable of rotation about the axis of cylindrical body 200, limited by wings 225 and 230. The inner surface 372 is provided with a circumferential rim 375 near the proximal end 365. Portions of rim 375 are removed to form openings 380 and 382 (only 380 is shown and 382 is substantially similar to 380), the openings 380 and 382 being sized to allow passage of key 190. The openings begin at about +70 degrees and-70 degrees from vertical and form an arc of about 30 degrees. When fin assembly 30 is in the first position, rim 375 blocks key 190. In this first position, fin 300 is vertical when key 190 is blocked by rim 375. As fin 300 rotates clockwise or counterclockwise, cylindrical body portion 350 (and thus rim 375) rotates about the axis of body portion 200. When fin assembly 30 is rotated to a second position (a position approximately 60 degrees from vertical clockwise or counterclockwise to approximately 90 degrees from vertical) such that key 190 is aligned with opening 380 or 382 (depending on the direction of rotation), key 190 is free to travel distally in slot 260. When so done, needle shield assembly 110 moves in a distal direction under the influence of coil spring 180 against inner wall 114 of cylindrical body 112, thereby shielding the needle.

Thus, the combination of rim 375 and key 190 forms part of a trigger mechanism that enables the shield assembly to unlock and move in a distal direction when needle 10 is to be shielded.

When fin 300 is rotated into position against either wing 225 or fin 230, fin 300 can be secured to the skin of the patient. To this end, the fin 300 may be provided with an adhesive tape. Needle shield assembly 110 has a cylindrical body 112, and cylindrical body 112 has a proximal end 120 and a distal end 115. Lumen 117 extends between proximal end 120 and distal end 115 and is sized to axially receive needle 10 such that it can slide over needle 10. Needle shield assembly 110 is axially fitted into housing body 200 such that it can slide axially along passage 236. Proximal end 120 is provided with a key 190. As described above, key 190 fits into slot 260 and slot 560. Key 190 prevents shield assembly 110 from rotating relative to housing body 200. When it abuts the distal end of slot 260, it also prevents shield assembly 110 from exiting opening 220 of housing body 200 in a proximal direction.

At distal end 115 of needle shield assembly is a detent mechanism 116 for preventing rearward sliding movement of the shield assembly once needle 70 is shielded. The proximal end 115 has a stepped portion 150, i.e., a region of reduced diameter compared to the remaining cylindrical portion of the cylindrical body 112. Lumen 117 also has a reduced diameter (as compared to the diameter of lumen 117) in stepped portion 150. In this region, lumen 117 is referred to as lumen 118. Lumen 118 has a diameter only slightly larger than the outer diameter of needle 10. The coil spring 111 is threaded on the stepped portion 150. The rear end of the coil spring 111 abuts against a wall 114 formed at the intersection of the stepped portion 150 and the remainder of the cylindrical body 112. The coil spring 111 is a compression spring that applies an axial force in the proximal and distal directions. The stepped portion 150 is also provided with an opening 160 in the form of a specially shaped slot, the opening 160 extending in a distal direction approximately from the midpoint of the stepped portion 150 to the distal end 115 of the cylindrical body 112 (see fig. 10). Opening 160 is sized and shaped so that ball 122 is disposed therein with a portion of ball 122 extending into lumen 118 of cylindrical body 112 and abutting outer surface 11 of needle 10. The force in coil spring 111 keeps ball 122 pressed against needle 10. In this manner, shield assembly 110 can slide along needle 10 with very little friction. Opening 160 is also sized and shaped so that when ball 122 no longer abuts needle 10 (i.e., the tip passes ball 122), ball 122 can move distally toward distal end 115 of cylindrical body 112 and further radially into lumen 118, thereby blocking axial movement of needle 10 in the distal direction. This will be described in more detail below.

Cap 100 is a metal stamping sized to fit over stepped portion 150, thereby enclosing coil spring 111. Cap 100 is provided with an opening 170, which opening 170 is sized such that a portion of ball 122 can fit therein when needle 10 abuts ball 122, but ball 122 cannot escape through it. Cap 100 can be limited in size to fit over distal end 115 of cylindrical body 110, or it can extend along the entire length of cylindrical body 115 as an integral sheath.

Behind stepped portion 150, a coil spring 180 is located within lumen 117 of cylindrical body 112. The coil spring 180 is a compression spring whose force is applied axially in the proximal and distal directions. The distal end 191 of the coil spring 180 rests against the back of the inner wall 114 just behind the stepped portion 150. Proximal end 195 of coil spring 180 abuts proximal surface 552 of needle hub 50 (i.e., in the region of flange 570, but inside cylinder 555). Thus, coil spring 180 is captured within cylindrical body 112 of shield assembly 110 and within housing 20. When shield assembly 110 is in its non-actuated position, coil spring 180 is in a compressed state.

The operation of the stop mechanism 116 will now be described. Needle tip 70 has a beveled tip with two bevels, a first bevel 71 and a second bevel 72. Ball 122 aligns with bevel 71 as needle shield assembly 110 slides in a distal direction along the length of needle 10. When ball 122 encounters ramp 71 it is less radially constrained by needle 10 and it moves radially towards the axis of needle 10 under the force of coil spring 111. As such, ball 122 exits opening 170 in cap 100 and further radially inward into lumen 118. Ball 122 pivots about edge 155 of opening 170 and slides distally along the length of opening 160. When second ramp is aligned with ball 122, it moves as far as possible in opening 160 and is located directly above second ramp 72. At this point, it enters lumen 117 as far as possible, constrained by the size of opening 160 and distal end 101 of cap 100. The spring 111 expands and now radially constrains the ball 122. Ball 122 partially occludes lumen 118 thereby preventing passage of needle tip 70 and preventing shield assembly 110 from being pulled back to expose needle tip 70.

At this point, key 190 reaches distal end 270 of slot 260, thus preventing further distal movement of shield assembly 110 relative to needle 10. The distance from key 190 to needle tip 70 is such that when tip 70 is aligned with ball 122, there is sufficient space for ball 122 to move under cap 100 in opening 160. Upper surface 136 of distal end 101 of cap 100 (i.e., the portion of needle shield assembly 110 immediately radially outward of ball 122 against which ball 122 abuts when the shield is deployed) forms an angle a tangent to ball 122 when ball 122 moves to its position at least partially occluding lumen 118. This can be seen in fig. 5. This angle a is set to a value less than the minimum bevel angle β of needle tip 70 (bevel 72 in this example). In the embodiment described herein, the angle α between upper surface 136 of distal end 101 and ball 122 is about zero degrees. When the angle is too large relative to angle β, ball 122 will not be jammed. Distal end 158 of stepped region 155 and cap 100 are sized to protrude outward such that tip 70 cannot be exposed from shield assembly 110. Multiple balls may also be used, with the balls being disposed in the same multiple openings as openings 160 and 170. Thus, the outward protruding length can be reduced.

After deployment but before needle 10 is moved distally, a portion of ball 122 is in lumen 118 and a portion of it is urged against the inside of distal end 101 of cap 100 by spring 111. The top of ball 122 is below upper surface 136 of distal end 101 of cap 100. In an alternative embodiment, the expanded spring 111 closes the opening 170. When needle 10 is moved distally, it will abut ball 122, which ball 122 will press against the inside of end 101 of cap 100. This will prevent further distal movement of needle 10 and thus prevent exposure of needle tip 70 from shield assembly 110.

Lumen 118 is sized so that needle 10 fits snugly therein. Thus, when needle 10 is moved distally (i.e., shield assembly 110 is moved proximally) and ball 122 abuts needle tip 70, needle 10 will not move away from ball 122. Lumen 170 thus provides support against ball 122 to prevent needle 10 from wobbling and to prevent tip 70 from moving to penetrate the walls of lumen 118.

In an alternative embodiment, ball 122 is fully advanced into lumen 118. At this point, ball 122 has a diameter slightly larger than the diameter of lumen 118. Ball 122 is then axially constrained by lumen 118 and needle 10. In this example, lumen 118 is also sized to provide support for needle 10 opposite ball 122, thereby preventing needle wobble and preventing tip 70 from penetrating the walls of lumen 118.

Ball 122 moves a distance at least equal to the amount it protrudes from opening 155 in cap 100. When the shield is deployed, ball 122 extends into lumen 118 by an amount approximately equal to this distance. This leaves a portion of lumen 118 unobstructed. When a smaller gauge needle is used, a larger ball is needed to block lumen 118 sufficiently to prevent tip 70 from protruding through the unblocked portion of lumen 118 and so that ball 122 will protrude from the surface of needle 10 into opening 160. The same effect can be obtained by making the cap 100 smaller and using the same size ball. When a larger gauge needle is used (i.e., when the needle has a larger diameter), the ball may be smaller.

The device 5 is assembled in the following way:

1. needle shield assembly 110 enters housing 20 from proximal end 210 of housing 20. Key 190 is aligned with slot 260 of housing 20.

2. The fin member 30 slides over the housing 20 from the proximal end 210 of the housing 20. During this step, fin 300 is at an angle of approximately 60-90 degrees from vertical, thereby aligning opening 380 or opening 382 with key 190. Fin member 30 is then rotated to the vertical position, locking key 190 behind rim 375.

3. Spring 180 is also disposed within lumen 117 of shield assembly 110 from proximal end 210 of housing 20. The distal end 191 of the spring 180 abuts the rear of the wall 114 of the needle shield.

4. Needle hub 50 snaps or glues onto proximal end 210 of housing 20, thereby compressing spring 180. Slot 570 in the cylindrical wall of hub 50 is aligned with slot 260 on housing 20.

5. Needle 10 is threaded through lumens 118, 117 and spring 180 into bore 113 of needle shield assembly 110 and glued into needle hub 50.

6. Tube 15 is glued into proximal end 555 of needle hub 50.

The device is used in the following way:

the user grasps wings 225 and 230 between his or her fingertips and brings them together so that they are in contact with fin 300. Alternatively, the device may be held simply by grasping fin 300 between the fingertips. Thus, a finger grip is provided in fin 300. When the device is held in either of these two ways with fin 300 in the vertical (first) position, the user pierces the patient's skin and blood vessel with needle tip 70. Once the blood vessel is penetrated and blood is able to flow through the needle, the user rotates fin 300 downward toward wing 225 or 230, thereby releasing key 190 (second position). In this way, needle shield assembly 110 is free to slide axially over the needle in the distal direction as urged by spring 180. Fin 300 is disposed in notch 250 or 255 such that it is flush with the associated wing. Wings 225 and 230 and fin 300 may be attached to the patient's skin when blood is collected.

In this blood collection (second) position, needle shield assembly 110 slides axially in the distal direction due to the force of spring 180. Distal end 115 of needle shield assembly rests against the patient's skin. When needle tip 70 is retracted, distal end 115 of needle shield assembly is still moved in a distal direction by spring 180 until it is fully shielded when tip 70 is removed from the patient.

The shielding mechanism at the needle tip prevents needle shield assembly 110 from sliding in the proximal direction and re-exposing needle tip 70. Key 190 abuts distal end 270 of slot 260 thereby preventing distal movement of needle shield assembly 110. In this way, needle 10 is completely shielded. Even when fin 300 is rotated back to the first position (to facilitate removal of needle 10 from the patient), shield assembly 110 cannot be withdrawn because it is blocked from proximal movement by ball 122. Key 190 has moved distally relative to circumferential rim 375.

While limited embodiments of winged needle assemblies, their components, and their use with different needle devices have been specifically described and illustrated, such illustrations are not intended to limit the scope of the basic invention. Many variations and modifications will be apparent to those of ordinary skill in the art. It should also be understood, therefore, that winged needle assemblies and their components constructed in accordance with the principles of the present invention may be practiced otherwise than as specifically described herein. The invention is also defined in the following claims.

Claims (16)

1. A medical needle assembly comprising:

a needle comprising a longitudinal axis, a proximal end, a sharp distal end, and an outer surface;

a housing having at least one outwardly extending wing;

a finned member secured to the housing such that the finned member is oriented generally radially outwardly relative to the longitudinal axis of the needle and is rotatable relative to the housing from a first non-shielding position to a second shielding position;

a needle shield assembly mounted relative to the housing such that the needle shield assembly is slidable longitudinally along the needle;

a release mechanism associated with the fin member and the needle shield assembly such that when the fin member is rotated from the first non-shielding position to the second shielding position, the needle shield assembly is unlocked and can slide along the needle shaft relative to the housing to shield the needle.

2. The needle assembly of claim 1, wherein: in the first non-shielding position, the fin members are oriented from approximately perpendicular to approximately 60 degrees from vertical.

3. The needle assembly of claim 1, wherein: the flaps are movable so that the flaps can move toward the fin member when the fin member is in the first non-shielding position.

4. The needle assembly of claim 3, wherein: the wing plate may be rotated toward the fin member.

5. The needle assembly of claim 3, wherein: the wing panel may be folded towards the fin section.

6. The needle assembly of claim 1, wherein: the housing is provided with a second outwardly extending flap.

7. The needle assembly of claim 1, further comprising: a spring biasing the needle shield assembly toward the second shielding position.

8. The needle assembly of claim 6, wherein: the wings are rotatable relative to the housing to enable the wings to move toward the fin member when the fin member is in the first non-shielding position.

9. A medical needle assembly comprising:

a needle comprising a longitudinal axis, a proximal end, a sharp distal end, and an outer surface;

a housing having a pair of outwardly extending wings disposed opposite one another and movable toward one another relative to the housing;

a finned member secured to the housing such that the finned member is oriented generally radially outwardly relative to the longitudinal axis of the needle and is rotatable relative to the housing from a first non-shielding position to a second shielding position;

a needle shield assembly mounted relative to the housing such that the needle shield assembly is slidable longitudinally along the needle;

a release mechanism associated with the fin member and the needle shield assembly such that when the fin member is rotated from the first non-shielding position to the second shielding position, the needle shield assembly is unlocked and can slide along the needle shaft relative to the housing to shield the needle.

10. The needle assembly of claim 9, wherein: in the first non-shielding position, the fin members are oriented from approximately perpendicular to approximately 60 degrees from vertical.

11. The needle assembly of claim 9, wherein: the flaps are movable so that the flaps can move toward the fin member when the fin member is in the first non-shielding position.

12. The needle assembly of claim 11, wherein: the wing plate may be rotated toward the fin member.

13. The needle assembly of claim 11, wherein: the wing panel may be folded towards the fin section.

14. The needle assembly of claim 9, further comprising: a spring biasing the needle shield assembly to the second shielding position such that the needle shield moves over the needle when the fin member is rotated to the second shielding position.

15. The needle assembly of claim 9, wherein: the wings are rotatable relative to the housing to enable the wings to move toward the fin member when the fin member is in the first non-shielding position.

16. A medical needle assembly comprising:

a needle comprising a longitudinal axis, a proximal end, a sharp distal end, and an outer surface;

a housing having at least one outwardly extending wing;

a finned member secured to the housing such that the finned member is oriented generally radially outwardly relative to the longitudinal axis of the needle and is rotatable relative to the housing from a first non-shielding position to a second shielding position;

a needle shield assembly mounted relative to the housing such that the needle shield assembly is slidable longitudinally along the needle, the needle shield assembly comprising an integral sheath;

a release mechanism associated with the fin member and the needle shield assembly such that when the fin member is rotated from the first non-shielding position to the second shielding position, the needle shield assembly is unlocked and can slide along the needle shaft relative to the housing to shield the needle.