# US 12,005,243 B2 · Hard-packaged safety needle device

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- Number: US 12,005,243 B2
- Document ID: US12005243B2
- Status: Granted
- Kind: B2
- Application number: 17/315,856
- Filed: 2021-05-10
- Published: 2021-11-18
- Granted: 2024-06-11
- Earliest claimed: 2020-05-12
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Kevin M. Ryan
- Web page: https://patentgrep.com/patent/US12005243B2

## CPC

- 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 5/3216: {Caps placed transversally onto the needle, e.g. pivotally attached to the needle base}
- A61M 5/3245: {Constructional features thereof, e.g. to improve manipulation or functioning}
- A61M 5/34: Constructions for connecting the needle {, e.g. to syringe nozzle or needle hub (connecting catheter tubes to hubs A61M25/0014)}
- A61M 5/345: {Adaptors positioned between needle hub and syringe nozzle}
- A61M 5/346: {friction fit (A61M5/344 takes precedence)}
- A61M 5/348: {snap lock, i.e. upon axial displacement of needle assembly (A61M5/344 takes precedence)}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/321: {Means for protection against accidental injuries by used needles}
- A61M 5/3293: {characterised by features of the needle hub}
- A61M 2005/3109: {Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin}
- A61M 2205/6063: Optical identification systems
- 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)}

## Abstract

A hard-packaged safety needle device comprises a needle hub having a needle cannula extending therefrom and a hard needle enclosure including a needle cover and a cap. The needle cover has an elongated body and a ribbed surface configured to create an interference fit with a proximal portion of the hub. The cap includes a body having an open distal end, a closed proximal end, and a cavity defined by the open distal end and the closed proximal end, the open distal end of the cap abutting an open proximal end of the needle cover.

## Claims

### Claim 1

A hard-packaged safety needle device comprising:
a needle hub configured to couple to a syringe comprising a distal portion and a proximal portion;
a needle cannula extending from the distal portion of the needle hub; and
a hard needle enclosure including a needle cover and a cap, the needle cover having an elongated body, a cavity defined by an open proximal end and a closed distal end, a proximal portion, a medial portion and a distal portion, the proximal portion having a surface configured to mate with the cap, the medial portion being defined by a flange extending from the elongated body, the elongated body further having an inner surface of the cavity having a proximal inner surface, a medial inner surface, and a distal inner surface, the proximal inner surface including a ribbed surface configured to create an interference fit with the proximal portion of the hub,
the cap including a body having an open distal end, a closed proximal end, and a cavity defined by the open distal end, the closed proximal end, and an inner surface, the open distal end of the cap abutting the open proximal end of the needle cover, the cap further comprising a plurality of protrusions extending from the inner surface of the cavity of the cap, the plurality of protrusions extending longitudinally from the inner surface and comprising a distal portion adjacent to the open distal end of the cap, the distal portion tapering inwardly from the open distal end, the taper configured to create an interference fit with the proximal portion of the needle cover upon insertion of the cap over the proximal portion of the needle cover.

### Claim 2 (depends on 1)

The hard-packaged safety needle device of claim 1, the needle hub further comprising a plurality of longitudinal ribs extending from the distal portion of the needle hub.

### Claim 3 (depends on 2)

The hard-packaged safety needle device of claim 2, wherein the medial inner surface of the needle cover includes a plurality of protrusions extending from the medial surface, the plurality of protrusions being configured to interdigitate with the plurality of longitudinal ribs of the needle hub.

### Claim 4 (depends on 3)

The hard-packaged safety needle device of claim 3, wherein each of the plurality of longitudinal ribs nest between two of the plurality of protrusions, preventing rotational movement of the needle hub.

### Claim 5 (depends on 1)

The hard-packaged safety needle device of claim 1, wherein a removable interference fit is created between the proximal portion of the needle hub and the ribbed surface of the proximal inner surface.

### Claim 6 (depends on 1)

The hard-packaged safety needle device of claim 1, wherein a proximal portion of the plurality of protrusions of the cap extends further from the inner surface of the cap and is configured to abut the proximal portion of the needle hub upon insertion of the cap over the proximal portion of the needle cover.

### Claim 7 (depends on 1)

The hard-packaged safety needle device of claim 1, further comprising a sleeve comprising an open proximal end, an open distal end and a plurality of perforations disposed radially around the needle hub, the plurality of perforations configured to break upon separation of the needle cover from the cap.

### Claim 8 (depends on 7)

The hard-packaged safety needle device of claim 7, the sleeve further comprising a tab integrally formed with the sleeve.

### Claim 9 (depends on 8)

The hard-packaged safety needle device of claim 8, wherein the tab includes labeling or instructions.

### Claim 10 (depends on 7)

The hard-packaged safety needle device of claim 7, wherein the sleeve is heat-sealed to the needle cover and the cap.

### Claim 11 (depends on 7)

The hard-packaged safety needle device of claim 7, wherein the sleeve is configured as a tamper-evident seal.

### Claim 12 (depends on 7)

The hard-packaged safety needle device of claim 7, wherein the sleeve fully covers the cap and the proximal end of the needle cover.

### Claim 13 (depends on 7)

The hard-packaged safety needle device of claim 7, wherein the plurality of perforations is near or directly over the open distal end of the cap and the open proximal end of the needle cover when the hard needle enclosure is assembled.
