# US 2014/0154670 A1 · Validation techniques for fluid delivery systems

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- Number: US 2014/0154670 A1
- Document ID: US20140154670A1
- Status: Published application
- Kind: A1
- Application number: 14/097,859
- Filed: 2013-12-05
- Published: 2014-06-05
- Earliest claimed: 2012-12-05
- Assignees: Bracco Imaging S.P.A.
- Applicants: Bracco Imaging S.p.A
- Inventors: Robert C. Williams, JR.; Patrice Marchildon
- Web page: https://patentgrep.com/patent/US20140154670A1

## CPC

- G01M 3/2853: {for pipe joints or seals (G01M3/30 takes precedence)}
- A61L 2/18: Liquid substances
- A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
- A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00)
- A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves}
- A61M 5/1413: {Modular systems comprising interconnecting elements}
- A61M 5/14232: {Roller pumps}
- C12Q 1/18: Testing for antimicrobial activity of a material
- C12Q 1/22: Testing for sterility conditions
- G01N 31/226: {for investigating the degree of sterilisation}
- G01N 33/50: Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q)
- G01N 2013/003: {Diffusion; diffusivity between liquids}
- Y10T 436/13: Tracers or tags
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- 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)
- 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)}
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

## Claims

### Claim 1

A method comprising:
applying one or more pathogens to a connection between a medical fluid container and a fluid transfer set, wherein the fluid transfer set is configured to transfer a fluid from the medical fluid container to a fluid pressurizing unit;
drawing the fluid from the medical fluid container, through the fluid transfer set, and into the fluid pressurizing unit;
extracting one or more samples of the fluid from at least one of the fluid transfer set and the fluid pressurizing unit; and
analyzing the one or more samples to determine a concentration level of the one or more pathogens in the one or more samples.

### Claim 2 (depends on 1)

The method of claim 1, further comprising assembling a fluid delivery system by at least placing the fluid transfer set in fluid communication with the fluid pressurizing unit and the medical fluid container so as to establish fluid communication between the medical fluid container and the fluid pressurizing unit via the fluid transfer set.

### Claim 3 (depends on 2)

The method of claim 2, wherein assembling the fluid delivery system comprises assembling the fluid delivery system subsequent to applying the one or more pathogens.

### Claim 4 (depends on 2)

The method of claim 2, further comprising applying a disinfectant to the connection between the medical fluid container and the fluid transfer set prior to assembling the fluid delivery system.

### Claim 5 (depends on 4)

The method of claim 4, wherein applying the disinfectant comprises wiping a cap of the medical fluid container and a mechanical connector on the fluid transfer set configured to mate with the medical fluid container with a sterile alcohol pad.

### Claim 6 (depends on 1)

The method of claim 1, wherein the fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube.

### Claim 7 (depends on 6)

The method of claim 6, wherein the pressurizing unit comprises one of a syringe and a peristaltic pump.

### Claim 8 (depends on 6)

The method of claim 6, wherein the medical fluid container has an opening sealed by a septum configured to be pierced by the bottle spike.

### Claim 9 (depends on 8)

The method of claim 8, wherein applying the one or more pathogens to the connection between the fluid transfer set and the medical fluid container comprises applying the one or more pathogens to at least one of the septum of the medical fluid container and the bottle spike and, subsequent to applying the one or more pathogens, inserting the bottle spike into the medical fluid container.

### Claim 10 (depends on 1)

The method of claim 1, further comprising applying the pathogen to a connection between the fluid transfer set and the fluid pressurizing unit and, subsequent to applying the pathogen, connecting the fluid transfer set to the fluid pressurizing unit.

### Claim 11 (depends on 1)

The method of claim 1, wherein extracting the one or more samples of the fluid from the fluid pressurizing unit comprises operating the fluid pressurizing unit to discharge fluid out of the fluid outlet.

### Claim 12 (depends on 1)

The method of claim 1, wherein the medical fluid container is sized to provide multiple doses of the fluid to multiple different patients.

### Claim 13 (depends on 1)

The method of claim 1, wherein the fluid comprises one of a contrast agent configured to provide contrast during a diagnostic imaging procedure and saline.

### Claim 14 (depends on 1)

The method of claim 1, further holding the medical fluid in the fluid transfer set and the fluid pressurizing unit, and determining if chemical degradation of the at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the medical fluid.

### Claim 15 (depends on 14)

The method of claim 14, wherein determining if chemical degradation of the at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the medical fluid comprises analyzing the one or more samples to determine if particles of material from the fluid transfer set or fluid pressurizing unit are present in the sample.

### Claim 16 (depends on 14)

The method of claim 14, wherein determining if chemical degradation of the at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the medical fluid comprises analyzing the one or more samples to determine if a chemical present in a material from which the fluid transfer set or fluid pressurizing unit is formed has leached into the sample.

### Claim 17 (depends on 14)

A product validated by the method of claim 14.

### Claim 18 (depends on 1)

A product validated by the method of claim 1.

### Claim 19

A method comprising:
providing a fluid delivery system that includes a medical fluid container, a fluid pressurizing unit, and a fluid transfer set, wherein the fluid transfer set is connected to transfer a fluid from the medical fluid container to the fluid pressurizing unit;
drawing the fluid from the medical fluid container, through the fluid transfer set, and into the fluid pressurizing unit so that the fluid transfer set and fluid pressurizing unit are filled with the fluid;
placing a discharge outlet of the fluid pressurizing unit in fluid communication with a fluid reservoir containing a tracking fluid, wherein the tracking fluid contains a tracking agent, and wherein the fluid reservoir is closed so that the fluid pressurizing unit cannot draw the fluid from the medical fluid container and discharge the fluid into the fluid reservoir;
operating the fluid pressurizing unit so as to pressurize a portion of the fluid in the fluid pressurizing unit;
extracting one or more samples of the fluid from at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit; and
analyzing the one or more samples to determine a concentration of the tracking agent in the at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit.

### Claim 20 (depends on 19)

The method of claim 19, wherein the fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube.

### Claim 21 (depends on 19)

The method of claim 19, wherein the pressurizing unit comprises one of a syringe and a peristaltic pump.

### Claim 22 (depends on 19)

The method of claim 19, wherein the tracking agent is not present in the fluid from the medical fluid container and includes one of a dye, a bacterium, and a virus.

### Claim 23 (depends on 19)

The method of claim 19, further comprising:
applying one or more pathogens at a connection between the fluid transfer set and at least one of the medical fluid container and the fluid pressurizing unit;
determining if the one or more pathogens enter the fluid;
holding the fluid in the fluid transfer set and the fluid pressurizing unit; and
determining if chemical degradation of at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the fluid.

### Claim 24 (depends on 19)

A validated product produced by the method of claim 19.

### Claim 25

A method comprising:
applying one or more pathogens at a connection between a medical fluid container and a fluid transfer set and a connection between the fluid transfer set and a fluid pressurizing unit, the fluid transfer set being configured to provide fluid communication between the medical fluid container and the fluid pressurizing unit, and determining if the one or more pathogens enter a medical fluid in at least one of the medical fluid container, the fluid pressurizing unit, and the fluid transfer set; and
holding the medical fluid in the fluid transfer set and the fluid pressurizing unit, and determining if chemical degradation of the at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the medical fluid.

### Claim 26 (depends on 25)

The method of claim 25, further comprising, subsequent to applying the one or more pathogens, applying a disinfectant to the connection between the medical fluid container and the fluid transfer set and the connection between the fluid transfer set and the fluid pressurizing unit, and
assembling a fluid delivery system by at least placing the fluid transfer set in fluid communication with the fluid pressurizing unit and the medical fluid container so as to establish fluid communication between the medical fluid container and the fluid pressurizing unit via the fluid transfer set.

### Claim 27 (depends on 25)

The method of claim 25, wherein the fluid pressurizing unit comprises one of a syringe and a peristaltic pump, and wherein the fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube.

### Claim 28 (depends on 25)

The method of claim 25, wherein determining if chemical degradation of the at least one of the fluid transfer set and the fluid pressurizing unit causes a portion of the fluid transfer set or fluid pressurizing unit to enter the medical fluid comprises analyzing a sample of the medical fluid to determine if particles of material from the fluid transfer set or fluid pressurizing unit are present in the sample or if a chemical present in a material from which the fluid transfer set or fluid pressurizing unit is formed has leached into the sample.

### Claim 29 (depends on 25)

A product validated by the method of claim 25.