Medical needle safety apparatus and methods

Claim 1

Integral phlebotomy apparatus requiring but two injection molded parts, said apparatus comprising: a first molded part comprising a cylindrical barrel assembly having an opening at a first end for receiving an evacuated blood sampling tube, a needle hub disposed at an otherwise substantially closed second end wherein a hollow bore medical cannula is disposed and securely affixed to provide a fluid flow pathway to said evacuated blood sampling tube, and a foldable sheath hingeably affixed to said barrel assembly; a hollow bore cannula disposed through said sheath, which is folded to provide a pathway therethrough, and securely affixed in said needle hub and having a sharpened tip on at least an end of the cannula to form a percutaneous insertion point; a second molded part comprising an elongated internal pathway for protective cover for said needle and a means for being releasibly attached to said first molded part; said sheath comprising a plurality of serially interconnected substantially rigid segments each of which is interconnected to at least one adjacent segment by a living hinge, at least one segment comprising two opposing sides wherethrough access is provided to an open pathway, through which said cannula passes to form an axis of intersection between said cannula and at least one segment, and a channel in which the cannula is fully disposed when the sheath is linearly extended, said sheath and said hinges being disposed to permit folding of the sheath proximal to the cylindrical barrel in a first state to permit usable access to said cannula and said sharpened tip in a medical procedure, and extending of the sheath along said cannula to a planar disposition about 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 thereby forming a substantially rigid body which protectively encloses said sharpened tip and denies access thereto.

Claim 7

A method for manufacturing an integral phlebotomy assembly comprising the steps of: molding within a single injection mold a first injection molded part comprising a cylindrical barrel assembly having an opening at a first end for receiving an evacuated blood sampling tube, a hub disposed at an otherwise substantially closed second end wherein a hollow bore medical needle is disposed and secured to provide a fluid flow pathway to said evacuated blood sampling tube, and an articulated needle sheath hingeably affixed to said barrel assembly, said sheath comprising a plurality of linearly hingeably affixed segments, at least one segment comprising a passageway wherethrough said needle passes; folding said articulated needle sheath against said barrel assembly; securely affixing a hollow bore needle into said hub such that said needle is disposed through and securely affixed in said needle hub and slidably disposed through each at least one segment passageway, said needle having a sharpened tip on at least an end of the cannula to form a transcutaneous insertion point; and releasibly attaching a second molded part comprising an elongated internal pathway for protective cover for said needle to said first molded part.

Claim 8

A method for manufacturing an integral phlebotomy assembly comprising the steps of: molding within a single injection mold a first injection molded part comprising a cylindrical barrel assembly having an opening at a first end for receiving an evacuated blood sampling tube, a hub disposed at an otherwise substantially closed second end wherein a hollow bore medical needle is disposed and secured to provide a fluid flow pathway to said evacuated blood sampling tube, and an articulated needle sheath hingeably affixed to said barrel assembly, said sheath comprising a plurality of linearly hingeably affixed segments, at least one segment comprising a passageway wherethrough said needle passes; folding said articulated needle sheath against said barrel assembly; securely affixing a hollow bore needle into said hub such that said needle is disposed through and securely affixed in said needle hub and slidably disposed through each at least one segment passageway, said needle having a sharpened tip on at least an end of the cannula to form a transcutaneous insertion point; and releasibly attaching a second molded part comprising an elongated internal pathway for protective cover for said needle to said first molded part.

Claim 23

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 at least one of which is interconnected to at least one adjacent segment by an intersegment hinge, each segment comprising an open orifice, through which said cannula passes to form an axis of intersection about the cannula, and a channel in 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 hub 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 along the channel, said sheath further comprising at least one latching member which catches and securely affixes the cannula 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; 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 unfold segments of the sheath until said at least one latching member is latched relative to said cannula to form the substantially rigid body and thereby protectively enclose and deny access to said at least one sharpened tip.

Claim 24

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 at least one of which is interconnected to at least one adjacent segment by an intersegment hinge, each segment comprising an open orifice, through which said cannula passes to form an axis of intersection about the cannula, and a channel in 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 hub 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 along the channel, said sheath further comprising at least one latching member which catches and securely affixes the cannula 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; 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 unfold segments of the sheath until said at least one latching member is latched relative to said cannula to form the substantially rigid body and thereby protectively enclose and deny access to said at least one sharpened tip.