Tip shield for needle stick prevention

• US 7,713,243 B2
• Filed: 09/25/2007
• Issued: 05/11/2010
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hillman, Jason
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US11/861,085
• Publication Number:
  US 20090082732A1
• Time in Patent Office: 959 Days
• Field of Search: 604/162, 604/164.08, 604/110, 604/111, 604/161, 604/192
• US Class Current: 604/192
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle

Abstract

A vascular access system for preventing needle sticks includes a needle, a tip shield, and a housing. The needle may be a hypodermic needle or other conventional needle having a needle shaft terminating at a needle tip. The tip shield provides an enclosure defining a chamber. The enclosure includes a closed distal end and a proximal end that slidably engages the needle shaft. The enclosure further includes at least one side wall configured to slidably engage the needle shaft. The housing defines a passageway with respective proximal and distal openings through which the needle extends. The tip shield is also disposed in the passageway and is releasably retained therein. The needle and/or the tip shield is adapted to prevent the needle shaft from being completely withdrawn from the tip shield. The tip shield further secures the needle tip in the chamber upon withdrawal of the needle tip into the chamber.

Claims

1. A vascular access system for preventing injury, comprising:

a sharp having a shaft that terminates at a tip;

a tip shield having an enclosure defining a chamber, wherein the enclosure includes at least one side wall configured to slidably engage the shaft, a closed distal end, and a proximal end slidably engaging the shaft;

a housing defining a passageway with respective proximal and distal openings through which said sharp slidably extends, wherein the proximal opening of the housing releasably retains the tip shield in the passageway; and

wherein the sharp includes a region proximate to the tip, wherein the tip shield proximal end includes an opening adapted to slidably engage the shaft without allowing the region to pass proximally through the opening, and wherein the tip shield secures the tip in the chamber upon withdrawal of the tip into the chamber.

2. A vascular access system as defined in claim 1, wherein the proximal opening of the housing frictionally retains the tip shield to allow insertion of the tip shield into the passageway of the housing upon application of a nominal force and to prevent inadvertent withdrawal of the tip shield from the passageway.

3. A vascular access system as defined in claim 1, wherein at least one of the housing and the tip shield includes blood stabilizing materials.

4. A vascular access system as defined in claim 1, wherein the shaft region includes an enlarged region proximate to the tip.

5. A vascular access system as defined in claim 1, wherein the tip shield comprises an elongate hollow body defining the chamber and a shaft port, a proximal end wall at the proximal end of the tip shield with a pivot hole that slidably and pivotally engages the shaft, and a distal end wall at the distal end of the tip shield;

and wherein the shaft extends through the pivot hole and the shaft port when the sharp is disposed in the housing disposing the tip shield at an angle with the shaft.

6. A vascular access system as defined in claim 5, wherein the pivot hole of the proximal end wall engages the enlarged shaft region during proximal movement of the sharp relative to the housing and further proximally movement of the sharp relative to the housing causes the tip shield to pivot at the pivot hole drawing the tip into the needle shaft port and into the chamber.

7. A vascular access system as defined in claim 5, wherein the housing includes a finger extending into the passageway and engaging the shaft port to open the port facilitating sliding movement of the shaft within the port as the sharp is withdrawn from the housing.

8. A vascular access system as defined in claim 5, wherein the housing includes a biased member configured to bias the tip shield toward the shaft as the needle is moved proximally relative to the house to draw the tip into the shaft port and into the chamber.

9. A vascular access system as defined in claim 1, wherein the tip shield enclosure includes a body having opposing longitudinal edges and defining a substantially cylindrical cross-section, wherein the body is configured to engage the shaft and includes a shaft port comprising the opposing edges of the body disposed in a spaced apart relationship to allow the shaft to enter the chamber and to prevent emergence of the tip from the chamber.

10. A vascular access system as defined in claim 9, wherein the tip shield is formed from a stamped sheet of metal that includes a body of generally rectangular shape and respective dependent proximal and distal disks adapted to form proximal and distal end walls, the body being rolled to form the substantially cylindrical cross-section and shaft port, and the disks being bent ninety degrees to abut the substantially cylindrical body.

11. A vascular access system as defined in claim 9, wherein the body is extruded from plastic material and includes opposing longitudinal edges, wherein the proximal and distal ends of the tip shield are covered by respective end caps of plastic material.

12. A vascular access system as defined in claim 11, wherein the proximal and distal end caps are affixed to the body using a process chosen from the group consisting of adhesive and ultrasonic welding.

13. An extravascular system for accessing the vasculature of a patient, comprising:

a catheter assembly that defines a lumen extending from an opening at a distal end thereof to a catheter hub at a proximal end thereof;

a needle assembly that includes a needle hub disposed at a proximal end of a needle having a shaft disposed within said lumen defined by said catheter assembly, a needle tip extending from the opening of the catheter assembly, and an enlarged shaft region proximate to the needle tip;

a tip shield having an enclosure defining a chamber, wherein the enclosure includes a needle shaft port configured to slidably engage the needle shaft, a closed distal end, and a proximal end having an opening slidably engaging the needle shaft while preventing the enlarged shaft region from passing proximately through the opening;

a housing defining a passageway with respective proximal and distal openings through which said needle slidably extends, wherein the proximal opening of the housing releasably and frictionally retains the tip shield in the passageway to allow insertion of the tip shield into the passageway of the housing upon application of a nominal force and to prevent inadvertent withdrawal of the tip shield from the housing; and

wherein the needle shaft extends through the opening of the tip shield and the needle shaft port disposing the tip shield at an angle with the needle shaft, wherein the opening in the proximal end of the tip shield engages the enlarged shaft region during proximal movement of the needle relative to the housing, and wherein further proximal movement of the needle relative to the housing causes the tip shield to pivot drawing the needle tip into the needle shaft port and into the chamber, disposing the tip shield coaxially with the needle shaft.

14. A needle assembly for preventing needle sticks, comprising:

a hypodermic needle having a needle shaft that terminates at a needle tip;

a tip shield having an enclosure defining a chamber, wherein the enclosure includes a body, a proximal end, a closed distal end, and a needle trap means that slidably engages the needle shaft, wherein the needle trap means secures the needle tip in the chamber upon withdrawal of the needle tip into the chamber;

housing means for releasably retaining the needle and the tip shield; and

wherein withdrawal of the needle from the housing means causes said needle tip to be engaged by the needle trap means and secured within the chamber

wherein the needle includes a retention means for preventing the needle from passing proximally past the proximal end of the tip shield, and wherein the needle trap means includes a needle shaft port defined by the body the enclosure and a pivot hole at the proximal end of the tip shield, wherein the needle shaft extends through the pivot hole and the needle shaft port disposing the tip shield at an angle with the needle shaft, wherein the pivot hole engages the retention means during proximal movement of the needle relative to the housing means, and wherein further proximal movement of the needle relative to the housing means causes the tip shield to pivot drawing the needle tip into the needle shaft port and into the chamber, disposing the tip shield coaxially with the needle shaft.

15. A needle assembly as defined in claim 14, wherein the housing means comprises a passageway with respective proximal and distal openings through which the needle slidably extends, wherein the proximal opening of the housing means frictionally retains the tip shield to allow insertion of the tip shield into the passageway of the housing upon application of a nominal force and to prevent inadvertent withdrawal of the tip shield from the passageway.

16. A method for preventing needle sticks upon withdrawal of a hypodermic needle, comprising the steps of:

providing a needle assembly having a hypodermic needle, a tip shield, and a housing, wherein the needle includes a needle shaft that terminates at a needle tip and an enlarged needle shaft region proximate to the needle tip, wherein the tip shield includes an enclosure defining a chamber, wherein the enclosure includes a needle shaft port configured to slidably engage the needle shaft, a closed distal end, and a proximal end having an opening slidably engaging the needle shaft while preventing the enlarged shaft region from passing proximately through the opening;

wherein the housing defining a passageway with respective proximal and distal openings through which said needle slidably extends, wherein the proximal opening of the housing releasably retains the tip shield in the passageway;

passing the needle distally through the housing to engage the patient'"'"'s vascular system;

withdrawing the needle from the housing to cause the enlarged shaft region to engage the opening in the proximal end of the tip shield to move the needle tip through the needle shaft port and into the chamber; and

further withdrawing the needle from the housing to cause the tip shield to pass through the proximal opening of the housing.

17. A method for preventing needle sticks as defined in claim 16, wherein the needle shaft port is disposed on a side wall of the enclosure disposing the tip shield at an angle with the needle shaft when the tip shield is disposed in the housing, and wherein further proximal movement of the needle relative to the housing following engagement of the enlarged shaft region with the proximal end opening causes the tip shield to pivot drawing the needle tip into the needle shaft port and into the chamber.