# US 8,771,511 B2 · Disposable apparatus and kit for conducting dialysis

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- Number: US 8,771,511 B2
- Document ID: US8771511B2
- Status: Granted
- Kind: B2
- Application number: 13/346,714
- Filed: 2012-01-09
- Published: 2012-05-03
- Granted: 2014-07-08
- Earliest claimed: 2007-11-29
- Assignees: Fresenius Medical Care Holdings, Inc.
- Applicants: Thomas Patrick Robinson; Charles E. Clemens; David Jacob Mishelevich; James Roswell Braig; Barry Neil Fulkerson; Daniele Ghidoli; Russell Thomas Joseph
- Inventors: Thomas Patrick Robinson; Charles E. Clemens; David Jacob Mishelevich; James Roswell Braig; Barry Neil Fulkerson; Daniele Ghidoli; Russell Thomas Joseph
- Web page: https://patentgrep.com/patent/US8771511B2

## CPC

- A61M 1/3417: {using distinct filters for dialysis and ultra-filtration}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/156: {Constructional details of the cassette, e.g. specific details on material or shape}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/1563: {Details of incorporated filters}
- A61M 1/1565: {Details of valves}
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1621: {Constructional aspects thereof (semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00)}
- A61M 1/1696: {with dialysate regeneration}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3403: {Regulation parameters}
- A61M 1/36224: {with sensing means or components thereof}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/36226: {Constructional details of cassettes, e.g. specific details on material or shape}
- A61M 1/362265: {Details of valves}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- A61M 39/08: Tubes; Storage means specially adapted therefor
- A61M 2202/0413: Blood
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/126: with incorporated membrane filters
- A61M 2205/128: with incorporated valves
- A61M 2205/3313: used specific wavelengths
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/75: with filters
- A61M 2209/00: Ancillary equipment
- Y10T 137/85938: Non-valved flow dividers
- 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

An extracorporeal blood processing system comprises a plastic molded compact manifold that supports a plurality of molded blood and dialysate fluidic pathways along with a plurality of relevant sensors, valves and pumps. A disposable dialyzer is connected to the molded manifold to complete the blood circuit of the system. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine.

## Claims

### Claim 1

A disposable apparatus for a blood purification system comprising: a rigid plastic substrate, wherein said rigid plastic substrate has a H shape comprising a left member, a right member, and a connecting member, wherein each of the left, right, and connecting members house at least one flow path therein and wherein the left member comprises a first external port and the right member comprises a second external port that faces the first external port; and
a first flexible tube having a first end and a second end, wherein the first flexible tube is external to the rigid plastic substrate, wherein said first end of the first flexible tube is attached to the first external port on the left member, wherein said second end of the first flexible tube is attached to the second external port on the right member, and wherein said first flexible tube serves to connect a portion of the at least one flow path in said left member to the at least one flow path in said right member.

### Claim 2 (depends on 1)

The disposable apparatus of claim 1 wherein the disposable apparatus comprises an alignment mechanism for attaching said disposable apparatus to a panel positioned within a housing of a dialysis machine.

### Claim 3 (depends on 2)

The disposable apparatus of claim 2 wherein the alignment mechanism comprises a plurality of holes in a surface of the plastic substrate.

### Claim 4 (depends on 2)

The disposable apparatus of claim 2 wherein the alignment mechanism comprises a plurality of tabs in a surface of the plastic substrate, wherein said tabs are adapted to mate with latches on a surface of the panel.

### Claim 5 (depends on 1)

The disposable apparatus of claim 1 further comprising flexible tubing having a first end and a second end which is external to said rigid plastic substrate, wherein the first end is fixedly attached to a third external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an inlet of a dialyzer.

### Claim 6 (depends on 5)

The disposable apparatus of claim 5 further comprising flexible tubing having a first end and a second end which is external to said rigid plastic substrate, wherein the first end is fixedly attached to a fourth external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an outlet of a dialyzer.

### Claim 7 (depends on 1)

The disposable apparatus of claim 1 wherein the left member comprises a first portion of a second flow path and a third external port located at an edge of the left member and wherein the right member comprises a second portion of the second flow path and a fourth external port located at an edge of the right member.

### Claim 8 (depends on 7)

The disposable apparatus of claim 7 further comprising a second flexible tube having a first end and a second end which is external to said rigid plastic substrate, wherein said first end of the second flexible tube is attached to the third external port and wherein said second end of the second flexible tube is attached to the fourth external port.

### Claim 9 (depends on 8)

The disposable apparatus of claim 8 wherein the first flexible tube is substantially parallel to said second flexible tube.

### Claim 10 (depends on 9)

The disposable apparatus of claim 9 wherein each of said at least one flow path and second flow paths are isolated from each other.

### Claim 11

A disposable apparatus for a blood purification system comprising: a rigid plastic substrate, wherein said rigid plastic substrate has an I shape comprising a top member, a bottom member, and a connecting member, wherein each of the top, bottom, and connecting members house at least one flow path therein and wherein the top member comprises a first external port and the bottom member comprises a second external port that opposes the first external port; and
a flexible tube having a first end and a second end, wherein said flexible tube is external to the rigid plastic substrate, wherein said first end of the tube is attached to the first external port on the top member, wherein said second end of the tube is attached to the second external port on the bottom member, and wherein said tube serves to connect a portion of the at least one flow path in said top member to a portion of the at least one flow path in said bottom member; and a dialyzer wherein said dialyzer is fluidically coupled to the rigid plastic substrate.

### Claim 12 (depends on 11)

The disposable apparatus of claim 11 wherein the disposable apparatus comprises an alignment mechanism for attaching said disposable apparatus to a panel positioned within a housing of a dialysis machine.

### Claim 13 (depends on 12)

The disposable apparatus of claim 12 wherein the alignment mechanism comprises at least one of a plurality of holes in a surface of the plastic substrate, a plurality of tabs in a surface of the plastic substrate, wherein said tabs are adapted to mate with latches on a surface of the panel, or a plurality of contoured guides.

### Claim 14 (depends on 11)

The disposable apparatus of claim 11 further comprising flexible tubing having a first end and a second end, wherein said flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a third external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an inlet of the dialyzer.

### Claim 15 (depends on 14)

The disposable apparatus of claim 14 further comprising flexible tubing having a first end and a second end, wherein said flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a fourth external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an outlet of the dialyzer.

### Claim 16 (depends on 11)

The disposable apparatus of claim 11 wherein the top member comprises a first portion of a second flow path and a third external port located at an edge of the top member and wherein the bottom member comprises a second portion of the second flow path and a fourth external port located at an edge of the bottom member.

### Claim 17 (depends on 16)

The disposable apparatus of claim 16 further comprising a second flexible tube having a first end and a second end, wherein said second flexible tube is external to the rigid plastic substrate, wherein said first end of the second flexible tube is attached to the third external port and wherein said second end of the second flexible tube is attached to the fourth external port.

### Claim 18 (depends on 17)

The disposable apparatus of claim 17 wherein the flexible tube is substantially parallel to said second flexible tube.

### Claim 19 (depends on 1)

A kit comprising: the disposable apparatus of claim 1, wherein the disposable apparatus further comprises a dialyzer; flexible tubing having a first end and a second end, wherein the flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a third external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an inlet of the dialyzer; and second flexible tubing having a first end and a second end, wherein the second flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a fourth external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an outlet of the dialyzer.

### Claim 20 (depends on 11)

A kit comprising: the disposable apparatus of claim 11, wherein the disposable apparatus further comprises: first flexible tubing having a first end and a second end, the first flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a third external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an inlet of the dialyzer; and second flexible tubing having a first end and a second end, wherein the second flexible tubing is external to the rigid plastic substrate, wherein the first end is fixedly attached to a fourth external port attached to the rigid plastic substrate and wherein the second end is fixedly attached to an outlet of the dialyzer.

### Claim 21 (depends on 1)

A dialysis machine comprising a disposable apparatus as claimed in claim 1, further comprising: a door having an interior face; a housing with a panel wherein said housing and panel define a recessed region configured to receive said interior face; a first pump shoe attached to the interior face; and a surface of a first roller pump exposed through the panel, wherein said first pump shoe and said surface of the first roller pump are aligned such that, when the disposable apparatus is installed in said recessed region and the interior face of the door is received into the recessed region, the first flexible tube is positioned between the first pump shoe and surface of the first roller pump.

### Claim 22 (depends on 21)

The dialysis machine of claim 21, wherein the disposable apparatus comprises a second flexible tube that is external to the rigid plastic substrate, wherein the dialysis machine comprises a second pump shoe attached to the interior face, wherein the dialysis machine comprises a surface of a second roller pump exposed through the panel, and wherein said second pump shoe and said surface of the second roller pump are aligned such that, when the disposable apparatus is installed in said recessed region and the interior face of the door is received into the recessed region, the second flexible tube is positioned between the second pump shoe and surface of the second roller pump.

### Claim 23 (depends on 22)

The dialysis machine of claim 22, wherein the disposable apparatus comprises a third flexible tube that is external to the rigid plastic substrate, wherein the dialysis machine comprises a third pump shoe attached to the interior face, wherein the dialysis machine comprises a surface of a third roller pump exposed through the panel, and wherein said third pump shoe and said surface of the third roller pump are aligned such that, when the disposable apparatus is installed in said recessed region and the interior face of the door is received into the recessed region, the third flexible tube is positioned between the third pump shoe and surface of the third roller pump.

### Claim 24 (depends on 23)

The dialysis machine of claim 23, wherein the disposable apparatus comprises a fourth flexible tube that is external to the rigid plastic substrate, wherein the dialysis machine comprises a fourth pump shoe attached to the interior face, wherein the dialysis machine comprises a surface of a fourth roller pump exposed through the panel, and wherein said fourth pump shoe and said surface of the fourth roller pump are aligned such that, when the disposable apparatus is installed in said recessed region and the interior face of the door is received into the recessed region, the fourth flexible tube is positioned between the fourth pump shoe and surface of the fourth roller pump.