# US 2021/0330941 A1 · Rapidly Insertable Central Catheters Including Catheter Assemblies and Methods Thereof

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- Number: US 2021/0330941 A1
- Document ID: US20210330941A1
- Status: Published application
- Kind: A1
- Application number: 17/237,909
- Filed: 2021-04-22
- Published: 2021-10-28
- Earliest claimed: 2020-04-23
- Assignees: Bard Access Systems, Inc.
- Applicants: Bard Access Systems, Inc.
- Inventors: Glade H. Howell; Jason R. Stats; Huy Ngoc Tran
- Web page: https://patentgrep.com/patent/US20210330941A1

## CPC

- A61M 25/0111: {Aseptic insertion devices}
- A61M 25/0631: {having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0069: {Tip not integral with tube}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/06: Body-piercing guide needles or the like
- A61M 25/0693: {Flashback chambers}
- A61M 25/09: Guide wires
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 2025/024: {having a clip or clamp system}
- A61M 2210/125: Heart
- 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

Rapidly insertable central catheters (“RICCs”) including catheter assemblies and methods thereof are disclosed. A RICC assembly can include a RICC, an introducer, and a coupling system configured to couple the RICC and the introducer together. A catheter tube of the RICC includes a side aperture in a distal-end portion of the catheter tube, which opens into an introducing lumen extending from the side aperture to a distal end of the RICC. The introducer includes a syringe and an introducer needle having a cannula. The coupling system includes a distal coupler slidably attached to the catheter tube proximal of the side aperture. The cannula extends through a longitudinal through hole of the distal coupler, through the side aperture of the catheter tube, along the introducing lumen of the catheter tube, and through the distal end of the RICC when the RICC assembly is in at least a ready-to-deploy state thereof

## Claims

### Claim 1

A rapidly insertable central catheter (“RICC”) assembly, comprising:
a RICC including:
a catheter tube including:
a first section formed of a first material having a first durometer;
a second section formed of a second material having a second durometer less than the first durometer; and
a side aperture through a side of the catheter tube in a distal-end portion thereof but proximal of the first section of the catheter tube, the side aperture opening into an introducing lumen of the catheter tube that extends from at least the side aperture to a distal end of the RICC;
a catheter hub coupled to a proximal-end portion of the catheter tube; and
one or more extension legs, each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal-end portion thereof;
an introducer including an introducer needle having a cannula extending through the distal end of the RICC when the RICC assembly is in at least a ready-to-deploy state of the RICC assembly; and
a coupling system configured to couple the RICC and the introducer together, the coupling system including a distal coupler slidably attached to the catheter tube proximal of the side aperture.

### Claim 2 (depends on 1)

The RICC assembly of claim 1, wherein the cannula further extends through a longitudinal through hole of the distal coupler, through the side aperture of the catheter tube, and along the introducing lumen of the catheter tube before exiting through the distal end of the RICC when the RICC assembly is in at least the ready-to-deploy state thereof.

### Claim 3 (depends on 1)

The RICC assembly of claim 1, the distal coupler including a tab configured to allow a clinician to single handedly advance the RICC off the cannula with a single finger of a hand while holding the introducer between a thumb and another finger or fingers of the hand.

### Claim 4 (depends on 1)

The RICC assembly of claim 1, the introducer further including:
a syringe having a syringe tip coupled to a needle hub of the introducer needle; and
an access guidewire disposed in an access-guidewire lumen formed of at least a plunger lumen of a plunger of the syringe and a needle lumen of the introducer needle, the access guidewire having a length sufficient for extension of the access guidewire through the distal end of the RICC.

### Claim 5 (depends on 4)

The RICC assembly of claim 4, wherein the plunger includes a sealing mechanism in a proximal-end portion of the plunger for sealing off the access-guidewire lumen, the sealing mechanism configured to prevent blood from discharging through a proximal end of the plunger during a venipuncture or while withdrawing the access guidewire from a blood-vessel lumen of a patient.

### Claim 6 (depends on 5)

The RICC assembly of claim 5, wherein the access guidewire is captively disposed in the introducer by a stop about a proximal-end portion of the access guidewire and a closed end of an access-guidewire sterile barrier of a fixed length coupled to the proximal end of the plunger, the stop providing a distal limit to advancing the access guidewire and the closed end of the access-guidewire sterile barrier around the access guidewire providing a proximal limit to withdrawing the access guidewire.

### Claim 7 (depends on 4)

The RICC assembly of claim 4, the introducer further including a fluid-pressure indicator extending from a side arm of the needle hub, the fluid-pressure indicator fluidly coupled to the needle lumen of the introducer needle by way of a side-arm lumen of the side arm for observing blood flashback.

### Claim 8 (depends on 4)

The RICC assembly of claim 4, the coupling system further including a proximal coupler slidably attached to the catheter hub and removably attached to the syringe in the ready-to-deploy state of the RICC assembly, the coupling system configured to allow the RICC to slide relative to the introducer.

### Claim 9 (depends on 8)

The RICC assembly of claim 8, wherein the proximal coupler includes a catheter-hub clip from which the RICC is configured to suspend by the catheter hub in at least the ready-to-deploy state of the RICC assembly or the one-or-more extension legs when the proximal coupler is advanced thereover in an operating state of the RICC assembly.

### Claim 10 (depends on 9)

The RICC assembly of claim 9, wherein the proximal coupler includes a syringe clip within which the introducer is configured to rest by a distal-end portion of a barrel of the syringe in at least the ready-to-deploy state of the RICC assembly.

### Claim 11 (depends on 8)

The RICC assembly of claim 8, the RICC further including a collapsible catheter-tube sterile barrier over the catheter tube between the catheter hub and the distal coupler to which distal coupler the catheter-tube sterile barrier is coupled, the catheter-tube sterile barrier configured to split apart when a sterile-barrier tab of the catheter-tube sterile barrier is removed from the catheter-hub clip and the catheter-tube sterile barrier is pulled away from the catheter tube by the sterile-barrier tab.

### Claim 12 (depends on 11)

The RICC assembly of claim 11, wherein the catheter-tube sterile barrier has sufficient tensile strength to pull the distal coupler off the catheter tube without breaking when the sterile barrier splits down to the distal coupler while being pulled away from the catheter tube.

### Claim 13 (depends on 1)

The RICC assembly of claim 1, wherein the RICC includes a set of three lumens including a distal lumen, a medial lumen, and a proximal lumen formed of fluidly connected portions of three catheter-tube lumens, three hub lumens, and three extension-leg lumens, the introducing lumen of the catheter tube coincident with a distal-end portion of the distal lumen.

### Claim 14 (depends on 13)

The RICC assembly of claim 13, wherein the distal lumen has a distal-lumen aperture in a distal end of the RICC, the medial lumen has a medial-lumen aperture in the side of the catheter tube distal of the side aperture, and the proximal lumen has a proximal-lumen aperture in the side of the catheter tube distal of the side aperture but proximal of the medial-lumen aperture.

### Claim 15 (depends on 1)

The RICC assembly of claim 1, the RICC further including a maneuver guidewire disposed in the distal lumen having a length sufficient for extension of the maneuver guidewire to a lower ⅓ of a superior vena cava of a heart, the maneuver guidewire captively disposed in the RICC by a stop about a proximal-end portion of the maneuver guidewire and a closed end of a maneuver-guidewire sterile barrier of a fixed length coupled to a Luer connector, the stop providing a distal limit to advancing the maneuver guidewire and the closed end of the maneuver-guidewire sterile barrier around the maneuver guidewire providing a proximal limit to withdrawing the maneuver guidewire.

### Claim 16

A method for inserting a rapidly insertable central catheter (“RICC”) into a blood-vessel lumen of a patient, comprising:
obtaining a RICC assembly including the RICC, an introducer including a syringe coupled to an introducer needle, and a coupling system including a distal coupler that couples the RICC and the introducer together by distal-end portions thereof in at least a ready-to-deploy state of the RICC assembly;
establishing a needle tract from an area of skin to the blood-vessel lumen of the patient with a cannula of the introducer needle while holding a distal-end portion of a barrel of the syringe, the cannula extending through a longitudinal through hole of the distal coupler, through a side aperture in a distal-end portion of a catheter tube of the RICC, along an introducing lumen of the catheter tube, and out a distal end of the RICC for establishing the needle tract;
advancing a distal-end portion of the catheter tube into the blood-vessel lumen over the cannula; and
withdrawing the cannula from the introducing lumen by way of the side aperture of the catheter tube.

### Claim 17 (depends on 16)

The method of claim 16, further comprising aspirating blood with the syringe before withdrawing the cannula from the introducing lumen, thereby confirming the cannula is disposed in the blood-vessel lumen of the patient.

### Claim 18 (depends on 16)

The method of claim 16, wherein establishing the needle tract includes ensuring blood flashes back into a needle hub of the introducer needle, a side arm of the needle hub, or a fluid-pressure indicator extending from the side arm of the needle hub.

### Claim 19 (depends on 16)

The method of claim 16, wherein establishing the needle tract while holding the distal-end portion of the barrel of the syringe includes holding the barrel by a syringe clip around the distal-end portion of the barrel, the syringe clip part of a proximal coupler of the coupling system.

### Claim 20 (depends on 19)

The method of claim 19, wherein advancing the distal-end portion of the catheter tube into the blood-vessel lumen includes advancing the catheter tube into the blood-vessel lumen with a single finger of a hand while holding the barrel of the syringe by the syringe clip between a thumb and another finger or fingers of the hand, the distal coupler including a tab configured for advancing the catheter tube into the blood-vessel lumen with the single finger.

### Claim 21 (depends on 19)

The method of claim 19, wherein advancing the distal-end portion of the catheter tube into the blood-vessel lumen includes advancing a catheter hub of the RICC from a catheter-hub clip of the proximal coupler and, thereafter, one or more extension legs of the RICC within the catheter-hub clip, the RICC configured to suspend from the coupling system until at least withdrawing the cannula from both the introducing lumen and the longitudinal through hole of the distal coupler.

### Claim 22 (depends on 16)

The method of claim 16, further comprising advancing an access guidewire disposed in an access-guidewire lumen formed of at least a plunger lumen of a plunger of the syringe and a needle lumen of the introducer needle into the blood-vessel lumen beyond a distal end of the cannula before advancing the distal-end portion of the catheter tube into the blood-vessel lumen over the cannula.

### Claim 23 (depends on 22)

The method of claim 22, further comprising advancing a maneuver guidewire into the blood-vessel lumen by way of a distal lumen having a distal-lumen aperture in the distal end of the RICC, the introducing lumen of the catheter tube coincident with a distal-end portion of the distal lumen, thereby mandating withdrawing the cannula from the introducing lumen before advancing the maneuver guidewire into the blood-vessel lumen.

### Claim 24 (depends on 23)

The method of claim 23, further comprising advancing the distal-end portion of the catheter tube farther into the blood-vessel lumen over the maneuver guidewire and concomitantly sliding the distal coupler proximally toward a proximal-end portion of the catheter tube to uncover the catheter tube, the catheter tube covered by a collapsible sterile barrier between the proximal-end portion of the catheter tube and the distal coupler in at least the ready-to-deploy state of the RICC assembly.

### Claim 25 (depends on 24)

The method of claim 24, further comprising removing the sterile barrier and the distal coupler from the RICC by pulling a sterile-barrier tab of the sterile barrier opposite the distal coupler away from the catheter tube to split the sterile barrier apart, then pulling the distal coupler from the catheter tube by the sterile barrier to which the distal coupler is slidably attached.

### Claim 26 (depends on 23)

The method of claim 23, wherein the catheter tube includes a first section formed of a first material having a first durometer and a second section proximal of the first section formed of a second material having a second durometer less than the first durometer, the first section of the catheter tube configured with a column strength for advancing the catheter tube into the blood-vessel lumen over the access guidewire or the maneuver guidewire.