# US 9,770,200 B2 · Needle assembly with safety system for a syringe or fluid sampling device and method of making and using the same

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- Number: US 9,770,200 B2
- Document ID: US9770200B2
- Status: Granted
- Kind: B2
- Application number: 14/737,117
- Filed: 2015-06-11
- Published: 2015-10-01
- Granted: 2017-09-26
- Earliest claimed: 2011-12-28
- Assignees: Stat Medical Devices, Inc.
- Applicants: Stat Medical Devices, Inc.
- Inventors: Steven Schraga
- Web page: https://patentgrep.com/patent/US9770200B2

## CPC

- 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}
- A61B 5/15003: {for venous or arterial blood}
- A61B 5/150183: {Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing}
- A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/150572: {Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes}
- A61B 5/150603: {by rotation, e.g. bayonet or screw}
- A61B 5/150702: {fully automatically removed, i.e. the removing does not require any action by the user}
- A61B 5/150732: {Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube}
- A61B 5/150893: {by indicating if used, tampered with, unsterile or defective}
- A61B 5/150916: {by blocking components, e.g. piston, driving device or fluid passageway}
- A61B 5/153: {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 5/3213: {Caps placed axially onto the needle, e.g. equipped with finger protection guards (axially-extensible protective sleeves A61M5/3243)}
- A61M 5/3257: {Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means}
- A61M 5/3293: {characterised by features of the needle hub}
- A61M 5/46: having means for controlling depth of insertion
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61J 1/201: {having one piercing end}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

Needle assembly having the following modes of operation; a first mode wherein the safety shield can move to a first retracted position allowing injection of the piercing portion of needle from a position at least partially covering the piercing portion of the needle and a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode and is prevented from moving back to a position exposing the piercing portion of the needle.

## Claims

### Claim 1

A needle assembly connectable to an injection device, the needle assembly comprising:
a body;
a luer-lock interface arranged on a rear side of the body;
a needle for injecting or withdrawing fluids;
the needle having a portion retained in the body and a piercing portion projecting forwardly from the portion retained in the body;
a safety shield that is axially movable relative to the body at least between an initial position, an at least partially retracted position, and a post-use locking position; and
a spring biasing the safety shield away from the at least partially retracted position,
wherein the safety shield:
locks in the post-use locking position via an internal locking system, wherein the internal locking system is prevented from being contacted by a user's fingers; and
rotates at least partially as it moves from the initial position to the at least partially retracted position; and
wherein the needle assembly has the following modes of operation when installed on an injection device:
a first mode wherein the safety shield can move to a first retracted position during injection of the piercing portion of the needle into a container containing a substance that can be suctioned into the injection device;
a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode;
a third mode wherein the safety shield can move to a second retracted position during injection of the piercing portion of the needle into a surface that will receive the substance forced out of the injection device; and
a fourth mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the third mode.

### Claim 2 (depends on 1)

The needle assembly of claim 1, wherein in the second mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the first mode.

### Claim 3 (depends on 1)

The needle assembly of claim 1, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.

### Claim 4 (depends on 1)

The needle assembly of claim 1, wherein in the fourth mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the third mode.

### Claim 5 (depends on 1)

The needle assembly of claim 1, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.

### Claim 6 (depends on 1)

The needle assembly of claim 1, wherein when in the fourth mode, the safety shield is prevented from moving back to a position exposing the piercing portion of the needle.

### Claim 7 (depends on 1)

The needle assembly of claim 1, wherein the surface that will receive the substance forced out of the injection device is a skin surface.

### Claim 8 (depends on 1)

The needle assembly of claim 1, wherein the needle assembly can be removably installed on the injection device.

### Claim 9

A needle assembly connectable to an injection device, the needle assembly comprising:
a body;
a luer-lock interface arranged on a rear side of the body;
a needle for injecting or withdrawing fluids;
the needle having a portion retained in the body and a piercing portion projecting forwardly from the portion retained in the body;
a safety shield that is axially movable relative to the body at least between an initial position, an at least partially retracted position, and a post-use locking position; and
a spring biasing the safety shield away from the at least partially retracted position,
wherein the safety shield:
locks in the post-use locking position via an internal locking system, wherein the internal locking system is prevented from being contacted by a user's fingers; and
rotates at least partially as it moves from the initial position to the at least partially retracted position; and
wherein the needle assembly has the following modes of operation when installed on an injection device:
a first mode wherein the safety shield can move to a first retracted position during injection of the piercing portion of the needle into a container containing a substance that can be suctioned into the injection device;
a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode;
a third mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the second mode;
a fourth mode wherein the safety shield can move to a second retracted position during injection of the piercing portion of the needle into a surface that will receive the substance forced out of the injection device; and
a fifth mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the fourth mode and is prevented from moving back to a position exposing the piercing portion of the needle.

### Claim 10 (depends on 9)

The needle assembly of claim 9, wherein in the second mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the first mode.

### Claim 11 (depends on 9)

The needle assembly of claim 9, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.

### Claim 12 (depends on 9)

The needle assembly of claim 9, wherein in the fourth mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the third mode.

### Claim 13 (depends on 9)

The needle assembly of claim 9, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.

### Claim 14 (depends on 9)

The needle assembly of claim 9, wherein when in the fourth mode, the safety shield is prevented from moving back to a position exposing the piercing portion of the needle.

### Claim 15 (depends on 9)

The needle assembly of claim 9, wherein the surface that will receive the substance forced out of the injection device is a skin surface.

### Claim 16 (depends on 9)

The needle assembly of claim 9, wherein the needle assembly can be removably installed on the injection device.