# US 10,441,730 B2 · Pen needle assembly for delivering drug solution

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- Number: US 10,441,730 B2
- Document ID: US10441730B2
- Status: Granted
- Kind: B2
- Application number: 14/172,288
- Filed: 2014-02-04
- Published: 2014-07-03
- Granted: 2019-10-15
- Earliest claimed: 2009-03-03
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Michael A. DiBiasi; Robert Banik; Roger W. Groskopf; Min Wei
- Web page: https://patentgrep.com/patent/US10441730B2

## CPC

- A61B 17/3496: {Protecting sleeves or inner probes; Retractable tips (for protecting body piercing guide needles A61M25/0612)}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 5/329: {characterised by features of the needle shaft}
- A61M 5/3293: {characterised by features of the needle hub}
- A61M 5/46: having means for controlling depth of insertion
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/347: {rotatable, e.g. bayonet or screw (A61M5/344 takes precedence)}
- A61M 5/425: {Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means}
- Y10T 29/49815: Disassembling
- 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)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

In one aspect, a pen needle assembly is provided herein which includes a hub, and a needle fixed to the hub, the needle having proximal and distal ends with a lumen extending therebetween. The needle extends distally from the hub to define an exposed length between the distal end of the needle and the hub in the range of about 5.0 to 9.0 mm. The hub defines a post formed about the needle, the post having a distally-facing first skin engaging surface. The exposed length of the needle extends distally from the first skin engaging surface. The hub also defines a distally-facing second skin engaging surface which at least partially circumscribes the first skin engaging surface. The second skin engaging surface being located proximally of the first skin engaging surface. Advantageously, a pen needle assembly is provided having two skin engaging surfaces which provide stability in achieving subcutaneous injections.

## Claims

### Claim 1

A combination for use with a medical pen injector which requires shaking to prepare a medicament contained therein for administration to a patient, said combination comprising:
a medical pen injector adapted to receive a pen needle assembly;
the pen needle assembly including:
a hub having a post defined around a needle and having a first distally facing skin engaging surface, the hub further comprising an annular wall formed monolithically with the hub, the annular wall spaced radially away from the post with a second distally facing skin engaging surface, the annular wall having a cantilevered resilient snap formed in the annular wall and adjoined thereto, wherein the cantilevered resilient snap is shaped to flex where the cantilevered resilient snap adjoins the annular wall; and,
wherein said needle is fixed to said hub, and,
a shell comprising a snap recess, said shell configured for releasable retainment on said hub when said cantilevered resilient snap engages said snap recess, said shell being retainable on said hub with said shell covering at least a portion of said needle, the force of said retainment being provided by the engagement of the cantilevered resilient snap within the snap recess, the cantilevered resilient snap having a resilience sufficient to maintain said shell retained on said hub with said pen needle assembly being mounted to a medical pen injector with the medical pen injector being shaken to prepare a medicament contained therein for administration to a patient.

### Claim 2 (depends on 1)

The combination according to claim 1, wherein said needle extends distally from said hub to define an exposed length in the range of about 5.0 to 9.0 mm.

### Claim 3 (depends on 1)

The combination according to claim 1, wherein said shell includes a cup-shaped body having an interior formed to accommodate said pen needle assembly.

### Claim 4 (depends on 3)

The combination according to claim 3, wherein said body includes a distal end, said distal end being spaced from said needle with said pen needle assembly being accommodated in said body.

### Claim 5 (depends on 1)

The combination according to claim 1, further comprising a barrier sheet or film removably secured to said shell to wholly enclose said pen needle assembly with said shell.

### Claim 6 (depends on 5)

The combination according to claim 5, further comprising a grip connected to said barrier sheet or said film to facilitate removal thereof.

### Claim 7 (depends on 1)

The combination according to claim 1, wherein rotational movement of said shell is transferrable to said hub by contact between said resilient snap and said snap recess when said shell is in releasable retainment with said hub.

### Claim 8 (depends on 1)

The combination according to claim 1, further comprising an audible indication when said at least one recess receives said at least one cantilevered resilient snap to indicate said shell being properly mounted on said hub.

### Claim 9 (depends on 1)

The combination according to claim 1, wherein said shell is reconnectable to said hub after removal.

### Claim 10 (depends on 9)

The combination according to claim 9, wherein a proximal end of said needle is covered by said shell when said shell is reconnected to said hub.

### Claim 11 (depends on 1)

The combination according to claim 1, wherein said hub is internally threaded to facilitate connecting to the pen injector.

### Claim 12

A method of preparing a medicament for administration, comprising the steps of:
connecting a hub comprising a post defined around a needle and having a first distally facing skin engaging surface, the hub further comprising an annular wall formed monolithically with the hub, the annular wall spaced radially away from the post with a second distally facing skin engaging surface, the annular wall having a cantilevered resilient snap formed in the annular wall and adjoined thereto, wherein the cantilevered resilient snap is shaped to flex where the cantilevered resilient snap adjoins the annular wall and is disposed within a shell comprising a snap recess engaged with said cantilevered resilient snap to a medical pen injector containing the medicament;
shaking the medical pen injector after connecting the hub thereto to prepare the medicament;
retaining the she on the hub by the engagement of the cantilevered resilient snap within the snap recess, wherein the cantilevered resilient snap resilience is sufficient to maintain the shell on the hub when shaking the medical pen injector to prepare the medicament; and
removing the shell from the hub after shaking the medical pen injector.

### Claim 13 (depends on 12)

The method of preparing a medicament for administration according to claim 12, wherein said connecting step comprises rotating the shell to threadably engage the hub with the medical pen injector.

### Claim 14 (depends on 12)

The method of preparing a medicament for administration according to claim 12, further comprising reconnecting the shell to the hub after removal to cover a proximal end of a hub needle.

### Claim 15 (depends on 14)

The method of preparing a medicament for administration according to claim 14, further comprising generating an audible indication when reconnecting the shell to the hub to indicate that the shell is properly connected to the hub when the cantilevered resilient snap engages the snap recess.

### Claim 16 (depends on 12)

The method of preparing a medicament for administration according to claim 12, further comprising removing a sterility barrier connected to the shell prior to connecting the hub to the medical pen injector.
