# US 9,433,721 B2 · Vial spiking assemblies and related methods

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- Number: US 9,433,721 B2
- Document ID: US9433721B2
- Status: Granted
- Kind: B2
- Application number: 13/926,500
- Filed: 2013-06-25
- Published: 2014-12-25
- Granted: 2016-09-06
- Earliest claimed: 2013-06-25
- Assignees: Fresenius Medical Care Holdings, Inc.
- Applicants: Fresenius Medical Care Holdings, Inc.
- Inventors: Nigel Wright; Michael John Zang; Tom Monahan; John A. Barron; Douglas Mark Zatezalo
- Web page: https://patentgrep.com/patent/US9433721B2

## CPC

- A61M 1/3644: {Mode of operation}
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3646: {Expelling the residual body fluid after use, e.g. back to the body}
- A61M 1/3649: {using dialysate as priming or rinsing liquid}
- A61M 5/145: using pressurised reservoirs, e.g. by means of pistons
- A61M 2005/1402: {Priming}
- A61M 2205/584: having a color code
- A61M 2205/60: with identification means
- 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

This disclosure relates to vial spiking assemblies and related methods. In certain aspects, the vial spiking assemblies include a vial adapter having a base, a spike extending from a central region of the base, and a sidewall extending from the base and surrounding the spike. The base and the sidewalls partially, define a cavity that is configured to receive at least a portion of the vial. The assemblies also include a spike cover that is removably attached to the spike and that includes a material configured to indicate when the material is contacted with liquid.

## Claims

### Claim 1

A vial spiking assembly comprising:
a vial adapter comprising:
a base;
a spike extending from a central region of the base; and
a sidewall extending from the base and substantially surrounding the spike, the base and the side wall at least partially defining a cavity configured to receive a portion of a vial; and
a spike cover removably attachable to the spike, wherein the spike cover comprises a microporous material configured to indicate when the material has been contacted with liquid, wherein the microporous material has an average pore size capable of permitting air to flow therethrough and preventing liquid from flowing therethrough.

### Claim 2 (depends on 1)

The assembly of claim 1, wherein the microporous material is a color changing material that changes color when contacted by a liquid.

### Claim 3 (depends on 2)

The assembly of claim 2, wherein the color changing material is a microporous material impregnated with at least one of the following: bromophenol blue, cobalt chloride, a food dye, powder dye, and a color additive.

### Claim 4 (depends on 1)

The assembly of claim 1, wherein the microporous material is molded with a color additive that changes color when contacted with liquid.

### Claim 5 (depends on 1)

The assembly of claim 1, wherein the microporous material surrounds the spike when the spike cover is attached to the spike.

### Claim 6 (depends on 1)

The assembly of claim 1, wherein the spike cover is movable away from the base from a first position wherein the cover at least partially covers a tip of the spike of the vial adapter to a second position wherein the tip of the vial adapter is fully exposed.

### Claim 7 (depends on 1)

The assembly of claim 1, wherein the spike cover comprises a housing defining a cavity in which the microporous material is disposed.

### Claim 8 (depends on 7)

The assembly of claim 7, wherein the housing is formed of a gas permeable material.

### Claim 9 (depends on 7)

The assembly of claim 7, wherein the microporous material is visible through the housing.

### Claim 10

A dialysis system comprising:
a dialysis machine comprising:
a blood pump; and
a drug pump;
a blood line set comprising a blood line that can be operably connected to the blood pump and a drip chamber in fluid communication with the blood line; and
a fluid line set comprising a fluid line that can be connected to the drip chamber of the blood line set and to a vial adapter, the vial adapter comprising:
a base;
a spike extending from a central region of the base; and
a sidewall extending from the base and substantially surrounding the spike, the base and the side wall at least partially defining a cavity configured to receive a portion of a vial; and
a spike cover removably attachable to the spike, wherein the spike cover comprises a microporous material configured to indicate when the material has been contacted with liquid, wherein the microporous material has an average pore size capable of permitting air to flow through and preventing liquid from flowing through.

### Claim 11 (depends on 10)

The dialysis system of claim 10, wherein the microporous material is a color changing material that changes color when contacted by a liquid.

### Claim 12 (depends on 10)

The dialysis system of claim 10, wherein the drip chamber is downstream of the blood pump and the fluid line is connected to a top region of the drip chamber.

### Claim 13 (depends on 11)

The dialysis system of claim 11, wherein the color changing material is a microporous material impregnated with at least one of the following: bromophenol blue, cobalt chloride, a food dye, powder dye, and a color additive.

### Claim 14 (depends on 11)

The dialysis system of claim 11, wherein the microporous material is covalently bonded with a color additive that changes color when contacted with liquid.

### Claim 15 (depends on 10)

The dialysis system of claim 10, wherein the microporous material surrounds the spike when the spike cover is attached to the spike.

### Claim 16 (depends on 10)

The dialysis system of claim 10, wherein the spike cover comprises a housing defining a cavity in which the microporous material is disposed.

### Claim 17 (depends on 16)

The dialysis system of claim 16, wherein the housing is formed of a gas permeable material.

### Claim 18 (depends on 16)

The dialysis system of claim 16, wherein the microporous material is visible through the housing.

### Claim 19 (depends on 10)

The dialysis system of claim 10, wherein the drip chamber is downstream of the blood plump.

### Claim 20 (depends on 10)

The dialysis system of claim 10, wherein the fluid line is connected to a top portion of the drip chamber.

### Claim 21 (depends on 10)

The dialysis system of claim 10, wherein the dialysis machine is configured to pump priming fluid through the fluid line set toward the vial adapter until the priming fluid contacts the microporous material.

### Claim 22 (depends on 10)

The dialysis system of claim 10, wherein the dialysis machine is configured to pump priming fluid through the blood line set in a manner to overfill the drip chamber and cause the priming fluid to flow through the fluid line set toward the vial adapter, until the priming fluid contacts the microporous material.

### Claim 23 (depends on 1)

The vial spiking assembly of claim 1, wherein the microporous material forms an exterior of the spike cover.

### Claim 24 (depends on 10)

The dialysis system of claim 10, wherein the microporous material forms an exterior of the spike cover.
