# US 2014/0155801 A1 · Adjustable-length dual-lumen hemodialysis catheter and a method for its use

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- Number: US 2014/0155801 A1
- Document ID: US20140155801A1
- Status: Published application
- Kind: A1
- Application number: 13/691,988
- Filed: 2012-12-03
- Published: 2014-06-05
- Earliest claimed: 2012-12-03
- Inventors: Kenneth M. Zinn; Mark Steven Fisher
- Web page: https://patentgrep.com/patent/US20140155801A1

## CPC

- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 1/3661: {for haemodialysis}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 2025/0031: {characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment}
- A61M 2025/0286: {anchored in the skin by suture or other skin penetrating devices}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0261: {Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2039/0282: {with implanted tubes connected to the port}
- A61M 2039/087: {Tools for handling tubes, e.g. crimping tool for connecting tubes to a connector}
- 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

The present adjustable-length dual-lumen hemodialysis catheter can eliminate the need to stock various lengths of hemodialysis catheters and can provide a hemodialysis catheter, which can be trimmed to various lengths in order to precisely accommodate patients of various shapes and sizes. Specifically, the present adjustable-length dual-lumen hemodialysis catheter can comprise a cuff ring assembly, which can be secured at selected locations along the trailing limbs of the catheter allowing the cuff ring assembly to be installed in a location chosen to precisely fit a particular patient.

## Claims

### Claim 1

A cuff ring assembly for use with a dual-lumen hemodialysis catheter comprising:
a cuff ring comprising a hollow tube having a bottom end and a top end, wherein the bottom end comprises a first opening and the top end comprises a second opening and the cuff ring is configured to allow a proximal end of a dual-lumen hemodialysis catheter, comprising a first trailing limb and a second trailing limb, to pass into the cuff ring through the first opening and exit from the cuff ring through the second opening;
the top end further comprising a locking section configured to receive a cuff ring wedge through the second opening, wherein the cuff ring wedge is configured to be connected within the locking section; and
a cuff configured to be placed over the bottom end of the cuff ring.

### Claim 2 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff ring wedge, when connected within the locking section, creates a first limb opening located between the cuff ring wedge and the locking section, which is configured to allow the first trailing limb to pass through the first limb opening, and wherein the first trailing limb is secured to the cuff ring when it is placed within the first limb opening and the cuff ring wedge is connected to the locking section.

### Claim 3 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff ring wedge, when connected within the locking section, creates a second limb opening, located between the cuff ring wedge and the locking section, which is configured to allow the second trailing limb to pass to pass through the second limb opening, and wherein the second trailing limb is secured to the cuff ring when it is placed within the second limb opening and the cuff ring wedge is connected to the locking section.

### Claim 4 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff ring assembly comprises at least one suture wing connected to the cuff ring.

### Claim 5 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff ring wedge comprises barbs.

### Claim 6 (depends on 1)

The apparatus as recited in claim 1 wherein the bottom end of the cuff ring is tapered having a minimum circumference at the first opening.

### Claim 7 (depends on 1)

The apparatus as recited in claim 1 wherein the top end of the cuff ring is tapered having a maximum circumference at the second opening.

### Claim 8 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff ring wedge comprises one or more cuff ring wedge pegs and the locking section comprises one or more cuff ring wedge-mounting holes, each configured to receive a cuff ring wedge peg.

### Claim 9 (depends on 1)

The apparatus as recited in claim 1, wherein the cuff is configured to be placed subcutaneously into the patient so as to secure the bottom end of the cuff ring apparatus into the subcutaneous tissue by permitting tissue ingrowth around its entire circumference.

### Claim 10 (depends on 2)

The apparatus as recited in claim 2, wherein both the first limb opening and the first trailing limb are D-shaped.

### Claim 11 (depends on 3)

The apparatus as recited in claim 3, wherein both the second limb opening and the second trailing limb are D-shaped.

### Claim 12

A dual-lumen hemodialysis catheter apparatus comprising:
a dual-lumen hemodialysis catheter comprising a distal end and a proximal end, wherein the proximal end comprises a first trailing limb and a second trailing limb; and
a cuff ring assembly further comprising a cuff ring comprising a hollow tube having a bottom end and a top end, wherein the bottom end comprises a first opening and the top end comprises a second opening and the cuff ring is configured to allow the proximal end of the dual-lumen hemodialysis catheter to pass into the cuff ring through the first opening and exit from the cuff ring through the second opening, wherein the top end of the cuff ring further comprises a locking section configured to receive a cuff ring wedge through the second opening, and wherein the cuff ring wedge is configured to be connected within the locking section; and a cuff configured to be placed over the bottom end of the cuff ring.

### Claim 13 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff ring wedge, when connected within the locking section, creates a first limb opening located between the cuff ring wedge and the locking section, which is configured to allow the first trailing limb to pass through the first limb opening, and wherein the first trailing limb is secured to the cuff ring when it is placed within the first limb opening and the cuff ring wedge is connected to the locking section.

### Claim 14 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff ring wedge, when connected within the locking section, creates a second limb opening, located between the cuff ring wedge and the locking section, which is configured to allow the second trailing limb to pass through the second limb opening, and wherein the second trailing limb is secured to the cuff ring when it is placed within the second limb opening and the cuff ring wedge is connected to the locking section.

### Claim 15 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff ring assembly comprises at least one suture wing connected to the cuff ring.

### Claim 16 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff ring wedge comprises barbs.

### Claim 17 (depends on 12)

The apparatus as recited in claim 12 wherein the bottom end of the cuff ring is tapered having a minimum circumference at the first opening.

### Claim 18 (depends on 12)

The apparatus as recited in claim 12 wherein the top end of the cuff ring is tapered having a maximum circumference at the second opening.

### Claim 19 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff ring wedge comprises one or more cuff ring wedge pegs and the locking section comprises one or more cuff ring wedge-mounting holes, each configured to receive a cuff ring wedge peg.

### Claim 20 (depends on 12)

The apparatus as recited in claim 12, wherein the cuff is configured to be placed subcutaneously into the patient so as to secure the bottom end of the cuff ring apparatus into the subcutaneous tissue by permitting tissue ingrowth around its entire circumference.

### Claim 21 (depends on 13)

The apparatus as recited in claim 13, wherein both the first limb opening and the first trailing limb are D-shaped.

### Claim 22 (depends on 14)

The apparatus as recited in claim 14, wherein both the second limb opening and the second trailing limb are D-shaped.

### Claim 23 (depends on 12)

The apparatus as described in claim 12, wherein the distal end of the dual-lumen hemodialysis catheter comprises a split-tip.

### Claim 24 (depends on 12)

The apparatus as described in claim 12, wherein the distal end of the dual-lumen hemodialysis catheter comprises a step-tip.

### Claim 25

A method for using a dual-lumen hemodialysis catheter apparatus, comprising:
providing a dual-lumen hemodialysis catheter apparatus comprising: a dual-lumen hemodialysis catheter comprising a distal end and a proximal end, wherein the proximal end comprises a first trailing limb and a second trailing limb;
providing a cuff ring assembly further comprising a cuff ring comprising a hollow tube having a bottom end and a top end, wherein the bottom end comprises a first opening and the top end comprises a second opening and the cuff ring is configured to allow the proximal end of the dual-lumen hemodialysis catheter to pass into the cuff ring through the first opening and exit from the cuff ring through the second opening, wherein the top end of the cuff ring further comprises a locking section configured to receive a cuff ring wedge through the second opening, and wherein the cuff ring wedge is configured to be connected within the locking section; at least one suture wing connected to the cuff ring; at least one hub assembly; and a cuff configured to be placed over the bottom end of the cuff ring;
using a tunneler to retrograde tunneling the dual-lumen hemodialysis catheter apparatus into a large vein in a patient's upper torso using and extending the proximal end of the dual-lumen hemodialysis catheter from an incision made in a patient's chest using a scalpel;
placing the cuff ring assembly over the proximal end of the dual-lumen hemodialysis catheter by threading the proximal end of the hemodialysis catheter into the first opening located at the bottom of the cuff ring and out from the second opening located at the top of the cuff ring;
splitting the first trailing limb from the second trailing limb down to a selected point along at the proximal end of the dual-lumen hemodialysis catheter;
placing the cuff ring wedge between the first trailing limb and the second trailing limb and into the locking section of the cuff ring through the second opening at the top of the cuff ring;
connecting the cuff ring wedge to the locking section of the cuff ring assembly;
placing the cuff subcutaneously within the patient;
connecting at least one suture wing to the patient; and
trimming the first trailing limb to a selected length and trimming the second trailing limb to a selected length.

### Claim 26 (depends on 25)

The method described in claim 25 wherein the distal end of the dual-lumen hemodialysis catheter apparatus comprises a split-tip.

### Claim 27 (depends on 25)

The method as described in claim 25 wherein the distal end of the dual-lumen hemodialysis catheter apparatus comprises a step-tip.

### Claim 28 (depends on 25)

The method as recited in claim 25 wherein the cuff ring wedge of the dual-lumen hemodialysis catheter apparatus creates a first limb opening located between the cuff ring wedge and the locking section when connected within the locking section, which is configured to allow the first trailing limb to pass through the first limb opening, and wherein the first trailing limb is secured to the cuff ring when it is placed within the first limb opening and the cuff ring wedge is connected to the locking section.

### Claim 29 (depends on 25)

The method as recited in claim 25 wherein the cuff ring wedge of the dual-lumen hemodialysis catheter apparatus creates a second limb opening located between the cuff ring wedge and the locking section when connected within the locking section, which is configured to allow the second trailing limb to pass through the second limb opening, and wherein the second trailing limb is secured to the cuff ring when it is placed within the second limb opening and the cuff ring wedge is connected to the locking section.

### Claim 30 (depends on 28)

The method as recited in claim 28 wherein both the first limb opening and the first trailing limb are D-shaped.

### Claim 31 (depends on 29)

The method as recited in claim 29 wherein both the second limb opening and the second trailing limb are D-shaped.

### Claim 32 (depends on 25)

The method described in claim 25, wherein at least one hub assembly is connected to at least one trailing limb of the dual-lumen hemodialysis catheter.
