Medical needle safety apparatus and methods

• US 5,980,488 A
• Filed: 07/17/1998
• Issued: 11/09/1999
• Est. Priority Date: 01/10/1995
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US09/118,624
• Time in Patent Office: 480 Days
• Field of Search: 604/110, 604/187, 604/192, 604/198, 604/263
• US Class Current: 604/110
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150641 comprising means to impede repositioning of protection sleeve from covering to uncovering position
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 2005/3101 Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end
• CPC Class Codes: A61M 2005/3106 Plugs for syringes without needle
• CPC Class Codes: A61M 2005/3121 via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
• CPC Class Codes: A61M 2005/3206 Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe body
• CPC Class Codes: A61M 2005/3223 Means impeding or disabling repositioning of used needles at the syringe nozzle
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

Parts which may be integrally molded with a phlebotomy barrel or with a Luer fitting to provide, in a single molded part, an extendable safety enclosure for a medical cannula in phlebotomy, syringe and other general medical needle applications. Integrally molded part phlebotomy safety devices are disclosed which require only the integrally-molded part, a medical needle, a label and a transport needle cover to form a ready-to-use phlebotomy device. Upon removal of the label and needle cover, the device is ready for use in a medical procedure. The enclosure comprises a plurality of rigid segments serially connected by a plurality of intersegment hinges, which are preferably living hinges. The segments are disposed about a medical needle, folded upon each other during the medical procedure and extended at the end of the procedure to form a secure, substantially rigid safety shroud. During the procedure, the enclosure is folded and conveniently disposed about a proximal portion of the needle. At the end of the procedure, the enclosure is extended to protectively sheath and secure the needle in a substantially rigid structure formed in combination by the enclosure and the needle.

Claims

1. A safety apparatus for sheathing a medical needle, said apparatus comprising:

a hollow bore cannula securely affixed in a hub and having at least one sharpened tip to form the medical needle;

a part hingeably joined to said hub, said part comprising an elongated sheath which comprises a plurality of serially interconnected substantially rigid segments each of which is interconnected to at least one adjacent segment by a hinge, at least a distally disposed segment comprising an open orifice, through which said cannula passes to form a pivotal axis of intersection about the cannula, and a channel in which the cannula is disposed when the sheath is extended, said sheath and said hinges being disposed to permit folding of the sheath about the cannula in a first state to permit usable access to said sharpened tip in a medical procedure and extending of the sheath, while sliding and pivoting the distal segment relative to the cannula, to a substantially planar disposition along said cannula whereat the cannula is disposed along the channel, said sheath further comprising at least one latching member which catches and securely affixes the cannula relative to the sheath, said sheath and cannula, in combination, thereby forming a substantially rigid body which protectively encloses said sharpened tip and denies access thereto.

2. Safety apparatus according to claim 1 wherein a segment which encloses said sharpened tip comprises a closure of its channel distal from the sharpened tip.

3. Safety apparatus according to claim 1 wherein the segment closest to said hub comprises a button which, when disposed toward the cannula extends that segment and the other segments of said sheath along and about said cannula and causes the at least one latching member to be securely affixed relative to the cannula.

4. Safety apparatus according to claim 1 wherein said at least one latching member comprises two latching members.

5. Safety apparatus according to claim 1 wherein a sheath which encloses said sharpened tip comprises an increase in thickness above the channel in the sheath which further protects against contact with the sharpened tip.

6. Safety apparatus according to claim 1 wherein said distally disposed segment comprises a pair of parts disposed on opposite sides of said open orifice which firmly engage opposing sides of said cannula when said sheath is extended, thereby assuring rigidity of the combination of the cannula and extended sheath.

7. A safety apparatus for sheathing a medical needle, said apparatus comprising:

a hollow bore cannula securely affixed in a hub and having at least one sharpened tip to form the medical needle;

a part hingeably joined to said hub, said part comprising an elongated sheath which comprises a plurality of serially interconnected substantially rigid segments each of which is interconnected to at least one adjacent segment by an intersegment hinge, at least one segment comprising an open orifice, through which said cannula passes to form a pivotal axis of rotation about the cannula, and a channel along which the cannula is disposed when the sheath is linearly extended, said sheath and said hinges being disposed to permit folding of the sheath about the cannula in a first state to permit usable access to said sharpened tip in a medical procedure and extending of the sheath whereby the at least one sheath pivots about the cannula to a substantially planar disposition along said cannula whereat the needle is disposed within the channel, said sheath further comprising at least one latching member which catches and securely affixes the cannula relative to the sheath, said sheath and cannula, in combination, thereby forming a substantially rigid body which protectively encloses said sharpened tip and denies access thereto.

8. Safety apparatus according to claim 7 wherein a segment which encloses said sharpened tip comprises a closure of its channel distal from the hub and sharpened tip.

9. Safety apparatus according to claim 7 wherein the segment closest to said hub comprises a button which, when depressed to dispose that segment onto said cannula, extends said sheath along and about said cannula and causes the at least one latching member to be securely affixed to the cannula.

10. Safety apparatus according to claim 7 wherein said at least one latching member comprises two latching members.

11. Safety apparatus according to claim 7 wherein the at least one segment comprises a pair of parts disposed on opposite sides of said open orifice which firmly engage opposing sides of said cannula when said sheath is extended, thereby assuring rigidity of the combination cannula and extended sheath.

12. Safety apparatus according to claim 7 wherein said hub and said sheath are, in combination, a single, integral molded part.

13. A method for enclosing a sharpened medical needle in a safety shield comprising the steps of:

providing a hollow bore cannula securely affixed in a hub, said cannula having at least one sharpened tip to form the medical needle, and a part hingeably joined to said hub, said part comprising an elongated sheath which comprises a plurality of serially interconnected substantially rigid segments each of which is interconnected to at least one adjacent segment by an intersegment hinge, at least one segment comprising an open orifice, through which said cannula passes to form a pivotal axis of intersection about the cannula, and a channel in which the cannula is disposed when the sheath is slideably pivoted while being extended to a substantially planar disposition, said sheath and said hinges being disposed to permit folding of the sheath about the cannula in a first state to permit usable access to said sharpened tip in a medical procedure and extending of the sheath to a substantially planar disposition along said cannula whereat the cannula is disposed within the channel, said sheath further comprising at least one latching member which catches to securely affixes the sheath relative to the cannula, said sheath and cannula, in combination, thereby forming a substantially rigid body which protectively encloses said sharpened tip and denies access thereto;

displacing said sheath about said hub and cannula in a compact state such that said needle tip is accessible for a medical procedure;

at the end of the medical procedure, displacing a proximal segment of said sheath to slide and pivot at least one segment about the cannula and thereby unfold segments of the sheath until said at least one latching member is latched relative to said cannula to thereby form the substantially rigid body and protectively enclose and deny access to said at least one sharpened tip.