Flash Activated Passive Shielding Needle Assembly

• US 20090259201A1
• Filed: 04/15/2008
• Published: 10/15/2009
• Est. Priority Date: 04/15/2008
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Wilkinson, Bradley M., Hwang, Charles G.
• Granted Patent: US 9,924,898 B2
• Time in Patent Office: Days
• US Class Current: 604/263
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150374 Details of piercing elements or protective means for preventing accidental injuries by such piercing elements double-ended hollow needles A61B5/150473, A61B5/150389; single-ended hollow needles A61B5/150503, A61B5/150389
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150648 fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/1535 comprising means for indicating vein or arterial entry A61B5/1545 takes precedence
• CPC Class Codes: A61M 2005/3252 being extended by a member protruding laterally through a slot in the syringe barrel
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2202/0413 : Blood
• CPC Class Codes: A61M 2205/273 : preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2210/04 : Skin
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0612 : Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 25/0618 : having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0625 : with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
• CPC Class Codes: A61M 25/0637 : Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1626 : Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3205 : Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles for sharps A61B50/362; disintegrating apparatus in general B02C, e.g. B02C19/0075, B23H9/001; disposal of medical waste in general B09B3/00; receptacles for refuse disposal in general B65F1/00
• CPC Class Codes: A61M 5/321 : Means for protection against accidental injuries by used needles
• CPC Class Codes: A61M 5/3243 : being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/326 : Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3269 : guided by means not coaxially aligned with syringe barrel, e.g. channel-like member formed on exterior surface of syringe barrel for guiding a pushing rod connected to and displacing needle safety sheath
• CPC Class Codes: A61M 5/3293 : characterised by features of the needle hub

Abstract

A safety needle device includes a housing including a passageway with a needle cannula extending therefrom. A shielding member is movable between a first position in which a puncture tip of the needle cannula is exposed therefrom and a second position in which the puncture tip of the needle cannula is encompassed therein. The shielding member is maintained in the first position against a biasing force which biases the shielding member toward the second position. A fluid and/or temperature activation material, such as a hydrogel or a compressed sponge, is associated with the shielding member and is adapted to deform upon contact with a fluid medium and/or a certain temperature or temperature range. Fluid flowing through the needle cannula, such as blood flow during a blood collection procedure, causes the activation material to deform, such as through expansion, thereby releasing the shielding member from the first position and allowing the drive member to bias the shielding member toward the second position.

Claims

1. A needle assembly, comprising:

a housing including a passageway extending therethrough and a needle cannula having a puncture tip extending from a forward end thereof;

a shielding member movable with respect to the housing between a first position in which the puncture tip of the needle cannula is exposed and a second position in which the puncture tip of the needle cannula is shielded by the shielding member, the shielding member maintained in the first position against a biasing force provided by a drive member biasing the shielding member toward the second position; and

an activation material associated with the shielding member and adapted to deform upon the flow of fluid through the passageway of the housing,

wherein fluid flowing through the passageway of the housing causes the activation material to deform, thereby releasing the shielding member from the first position and causing the drive member to bias the shielding member toward the second position.

2. The needle assembly of claim 1, further comprising an interference engagement between the shielding member and the housing maintaining the shielding member in the first position against the biasing force.

3. The needle assembly of claim 1, further comprising capillary tubes disposed within the passageway of the housing and in fluid communication with the needle cannula for diverting a fluid from the needle cannula to the activation material.

4. The needle assembly of claim 1, wherein the drive member comprises a coil spring.

5. The needle assembly of claim 1, wherein the activation material comprises a material selected from the group consisting of hydrogels, compressed sponges, expandable foams, expandable powders, and the like, and combinations thereof.

6. The needle assembly of claim 1, wherein deformation of the activation material forces an actuator to release the shielding member from the first position.

7. The needle assembly of claim 1, wherein the activation material is deformed upon contact with the fluid.

8. The needle assembly of claim 1, wherein the activation material is deformed due to a temperature change caused by the fluid flowing through the passageway of the housing.

9. A shielding needle assembly comprising:

a needle cannula having a proximal end and a distal end with a puncture tip;

a needle hub having a proximal end and a distal end and a passage between the ends, with an interior portion of the needle hub distal end supporting the needle cannula proximal end;

a shielding member movable between a first position in which the puncture tip of the needle cannula is exposed and a second position in which the puncture tip of the needle cannula is shielded by the shielding member;

a drive member biasing the shielding member toward the second position, the shielding member and the needle hub including an interference engagement therebetween for maintaining the shielding member in the first position against a biasing force of the drive member; and

an activation material adapted to deform upon contact with a fluid medium flowing through the needle cannula, thereby causing the activation material to deform and release the interference engagement between the shielding member and the needle hub and allowing the drive member to bias the shielding member toward the second position.

10. The shielding needle assembly of claim 9, wherein the drive member comprises a coil spring.

11. The shielding needle assembly of claim 9, wherein the activation material comprises a material selected from the group consisting of hydrogels, compressed sponges, expandable foams, expandable powders, and the like, and combinations thereof.

12. The shielding needle assembly of claim 9, wherein the expansion of the activation material causes movement of an actuator which releases the interference engagement between the shielding member and the needle hub.

13. The shielding needle assembly of claim 9, wherein the interference engagement between the shielding member and the needle hub comprises a finger at the rearward end of the shielding member extending within a recess of the needle hub, and wherein expansion of the activation material releases the finger out of the recess.

14. The shielding needle assembly of claim 13, wherein deformation of the activation material causes movement of an actuator which contacts the finger of the shielding member to release it out of the recess of the needle hub.

15. A blood collection set comprising the shielding needle assembly of claim 9 including a flexible tube extending from the needle hub, the flexible tube comprising a non-patient needle cannula at an opposed end adapted for connection to a receptacle for blood collection.

16. A method of actuating a shielding needle assembly comprising:

providing a shielding needle assembly comprising a housing including a passageway extending therethrough and a needle cannula having a puncture tip extending from a forward end thereof and a shielding member in a first position biased toward a second position in which the puncture tip of the needle cannula is shielded by the shielding member, the shielding member maintained against the bias in the first position in which the puncture tip of the needle cannula is exposed; and

inserting the puncture tip of the needle cannula through the skin of a patient to allow a fluid medium to flow through the needle cannula;

wherein fluid flow through the needle cannula causes the shielding member to be released from the first position.

17. A method as in claim 16, further comprising removing the puncture tip of the needle cannula from the patient, thereby allowing the shielding member to be biased to the second position to cover the puncture tip of the needle cannula.

18. A method as in claim 16, wherein the shielding needle assembly further comprises an interference engagement between the shielding member and the housing and an activation material associated therewith, and wherein fluid flow through the needle cannula deforms the activation material, thereby releasing the interference engagement between the shielding member and the housing and allowing the shielding member to be biased toward the second position.

19. A method as in claim 18, further comprising diverting a portion of the fluid medium flowing through the needle cannula to the activation material thereby causing the activation material to deform and release the interference engagement between the shielding member and the housing.

20. The needle assembly of claim 19, wherein the activation material is deformed upon contact with the fluid.

21. The needle assembly of claim 18, wherein the activation material is deformed due to a temperature change caused by the fluid flowing through the passageway of the housing.

22. A method as in claim 18, wherein deformation of the fluid activated material causes an actuator to release the interference engagement between the shielding member and the housing.

23. A method as in claim 16, wherein the fluid medium comprises blood.

24. A shielding needle assembly comprising:

a needle cannula having a proximal end and a distal end with a puncture tip;

a needle hub having a proximal end and a distal end and a passage between the ends, with an interior portion of the needle hub distal end supporting the needle cannula proximal end;

a shielding member movable between a first position in which the puncture tip of the needle cannula is exposed and a second position in which the puncture tip of the needle cannula is shielded by the shielding member;

a drive member biasing the shielding member toward the second position, the shielding member and the needle hub including an interference engagement therebetween for maintaining the shielding member in the first position against a biasing force of the drive member; and

an activation material adapted to deform upon a change in temperature within the assembly, thereby causing the activation material to deform and release the interference engagement between the shielding member and the needle hub and allowing the drive member to bias the shielding member toward the second position.