# US 11,439,999 B2 · Purgeable pharmaceutical fill needle

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- Number: US 11,439,999 B2
- Document ID: US11439999B2
- Status: Granted
- Kind: B2
- Application number: 16/858,599
- Filed: 2020-04-25
- Published: 2020-12-10
- Granted: 2022-09-13
- Earliest claimed: 2018-11-09
- Assignees: V Anrx Pharmasystems Inc.
- Applicants: Vanrx Pharmasystems Inc.
- Inventors: Marcin Cichy; Juvenal Naing; Carlos Alberto Diaz Guerrero
- Web page: https://patentgrep.com/patent/US11439999B2

## CPC

- B01L 1/025: {Environmental chambers}
- A61J 1/12: with means for holding samples of contents
- A61J 1/14: Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00)
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61L 2/07: Steam
- A61L 2/16: using chemical substances
- A61L 2/24: Apparatus using programmed or automatic operation
- B01L 1/04: Dust-free rooms or enclosures
- B01L 3/02: Burettes; Pipettes
- B01L 3/0293: {for liquids}
- B25J 21/00: Chambers provided with manipulation devices (constructional features of the mounting of the manipulator in the wall B25J1/08 {; glove-boxes for nuclear applications G21F7/04})
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 3/04: Methods of, or means for, filling the material into the containers or receptacles
- B65B 55/12: Sterilising contents prior to, or during, packaging
- C12M 29/00: {Means for introduction, extraction or recirculation of materials, e.g. pumps (pumps per se F04B)}
- C12M 37/02: {Filters}
- C12M 41/14: {Incubators; Climatic chambers (per se B01L1/00)}
- G01N 35/00029: {provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence)}
- G01N 35/10: Devices for transferring samples {or any liquids} to, in, or from, the analysis apparatus, e.g. suction devices, injection devices {(G01N35/0099 takes precedence)}
- B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details
- B01L 2200/0689: Sealing
- B01L 2200/141: Preventing contamination, tampering
- B01L 2300/0609: Holders integrated in container to position an object
- B01L 2300/0832: cylindrical, tube shaped
- B01L 2400/0487: fluid pressure, pneumatics
- G01F 11/00: Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
- G01F 15/007: {comprising means to prevent fraud}
- G01N 35/0099: {comprising robots or similar manipulators (robots per se B25J)}
- G01N 2035/00148: {Test cards, e.g. Biomerieux or McDonnel multiwell test cards}
- G01N 2035/00277: {Special precautions to avoid contamination (e.g. enclosures, glove- boxes, sealed sample carriers, disposal of contaminated material)}
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- 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
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B25J: MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES ({manipulators specially adapted for use in surgery A61B34/70; manipulators used in cleaning hollow articles B08B9/04}; manipulators associated with rolling mills B21B39/20; manipulators associated with forging machines B21J13/10; {manipulators associated with picking-up and placing mechanisms B23P19/007}; means for holding wheels or parts thereof B60B30/00; {vehicles with ground-engaging propulsion means, e.g. walking members B62D57/02, B62D57/032; devices for picking-up and depositing articles or materials between conveyors B65G47/90, B65G47/91; manipulators with gripping or holding means for transferring packages B65H67/065}; cranes B66C; {manipulators used in the protection or supervision of pipe-line installations F17D5/00; walking equipment adapted for nuclear steam-generators F22B37/006}; manipulators specially adapted for, or associated with, nuclear reactors G21C; {apparatus used for handling wafers during manufacture or treatment of semiconductor H10P72/50})
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME

## Abstract

The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.

## Claims

### Claim 1

A fill needle for aseptically dispensing a pharmaceutical fluid in a chamber capable of maintaining an aseptic condition, the chamber having a pharmaceutical fluid source and a fluid pressure pulse induction system with associated flexible tubing, the fill needle comprising:
a fill needle hub,
a fill needle tubing in fluid communication with the pharmaceutical fluid source and extending through the fill needle hub;
a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing;
a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and
a fill needle fluid ejector operably coupled to the fluid pressure induction system for manipulating the dispensing of the pharmaceutical fluid through the fill needle dispensing tip.

### Claim 2 (depends on 1)

The fill needle of claim 1, wherein the chamber includes a controller and further comprising a actuator configured to control the dispensing of the pharmaceutical fluid via the dispensing tip upon activation by the controller.

### Claim 3 (depends on 2)

The fill needle of claim 2, wherein the controller is configured to operate the fluid pressure pulse induction system to automatically compress the flexible tubing after halting dispensing of the pharmaceutical fluid.

### Claim 4 (depends on 1)

The fill needle of claim 1, wherein the fluid pressure pulse inducer is one of piezoelectrically actuated, electromechanically actuated, magnetically actuated, and pneumatically actuated.

### Claim 5 (depends on 1)

The fill needle of claim 1, wherein the fill needle fluid ejector includes a vibration actuator.

### Claim 6 (depends on 5)

The fill needle of claim 5, wherein the fill needle fluid ejector includes hydrophobic material proximate the vibration actuator.

### Claim 7 (depends on 1)

The fill needle of claim 1, wherein the fill needle fluid ejector includes a gas injector.

### Claim 8 (depends on 7)

The fill needle of claim 7, wherein the fill needle fluid ejector includes hydrophobic material proximate the gas injector.

### Claim 9 (depends on 1)

The fill needle of claim 1, wherein the fill needle fluid ejector includes a mechanism for squeezing the fill needle tubing.

### Claim 10 (depends on 9)

The fill needle of claim 9, wherein the fill needle fluid ejector further includes a bladder.

### Claim 11 (depends on 10)

The fill needle of claim 10, wherein the fill needle fluid ejector injects gas into the bladder.

### Claim 12 (depends on 11)

The fill needle of claim 11, wherein the bladder is disposed around the fill needle tubing proximate the fill needle dispensing tip.

### Claim 13 (depends on 1)

The fill needle of claim 1, wherein the fill needle fluid ejector includes a levered piezoelectric actuator.

### Claim 14 (depends on 13)

The fill needle of claim 13, wherein the fill needle fluid ejector includes a bladder, and the levered piezoelectric actuator is disposed to compress the bladder upon actuation.

### Claim 15 (depends on 5)

The fill needle of claim 5, wherein the vibration actuator is disposed to vibrate the fill needle tubing.

### Claim 16 (depends on 5)

The fill needle of claim 5, wherein the fill needle dispensing tip includes hydrophobic material.

### Claim 17 (depends on 15)

The fill needle of claim 15, wherein the fill needle tubing includes hydrophobic material proximate the vibration actuator.

### Claim 18 (depends on 5)

The fill needle of claim 5, wherein the vibration actuator is configured to be actuated electromechanically.

### Claim 19 (depends on 5)

The fill needle of claim 5, wherein the vibration actuator is configured to be actuated piezoelectrically.

### Claim 20 (depends on 5)

The fill needle of claim 5, wherein the vibration actuator is configured to be actuated by a controller.