# US 2022/0032014 A1 · Splitable Needle and Dilator Catheter Placement Device and Associated Methods

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2022/0032014 A1
- Document ID: US20220032014A1
- Status: Published application
- Kind: A1
- Application number: 17/392,061
- Filed: 2021-08-02
- Published: 2022-02-03
- Earliest claimed: 2020-08-03
- Assignees: Bard Access Systems, Inc.
- Applicants: Bard Access Systems, Inc.
- Inventors: Glade H. Howell; Kyle G. Thornley; Zachary S. Hastings; Kent Diasabeygunawardena; Jon B. Taylor; Taylor C. Tobin; Jacquelyn N. Phelps; Daniel Hamilton
- Web page: https://patentgrep.com/patent/US20220032014A1

## CPC

- A61M 25/065: {Guide needles}
- A61M 25/0668: {splittable, tear apart}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0631: {having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle}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 2025/0675: {Introducing-sheath slitters}
- A61M 2205/02: characterised by a particular materials
- 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

Disclosed herein is a catheter placement system including a splittable needle and dilator. The system can include a housing having one or more flexible sections and a pleated section. A user can grasp an elongate medical device using the flexible sections and transition the housing pleated section between an extended and collapsed configuration to urge the elongate medical device proximally or distally. The system can also include a needle retraction mechanism configured to split the needle long a longitudinal axis and roll up the separate portions to allow one or more elongate medical devices to pass therebetween. The system can also include a dilator splitter configured to separate a dilator along a longitudinal axis and radially displace the dilator portions to allow one or more elongate medical devices to pass therebetween. Advantageously, the system can maintain the elongate medical device in a sterile environment, mitigating the introduction of pathogens.

## Claims

### Claim 1

A catheter placement system, comprising:
a catheter housing defining a longitudinal axis;
an elongate medical device disposed within an interior cavity of the catheter housing; and
a needle housing including a needle extending distally therefrom, the needle housing releasably coupled to a distal end of the catheter housing and including a needle retraction mechanism configured to split the needle along a longitudinal axis and retract the needle into the needle housing.

### Claim 2 (depends on 1)

The catheter placement system according to claim 1, wherein the needle housing includes a needle retraction lever hingedly coupled thereto and configured to actuate a gear mechanism disposed within the needle retraction mechanism.

### Claim 3 (depends on 1)

The catheter placement system according to claim 1, wherein the needle retraction mechanism is configured to roll up a portion of the needle about an axis extending perpendicular to the longitudinal axis.

### Claim 4 (depends on 1)

The catheter placement system according to claim 1, wherein the needle includes a sheath disposed on an outer surface thereof, one of the needle or the sheath includes a breach line.

### Claim 5 (depends on 1)

The catheter placement system according to claim 1, wherein the elongate medical device includes one of a dilator, a catheter, or a guidewire.

### Claim 6 (depends on 5)

The catheter placement system according to claim 5, wherein one of the dilator or the catheter includes one of a polyether ether ketone (PEEK) material, or a fluorinated ethylene propylene (FEP) material.

### Claim 7 (depends on 5)

The catheter placement system according to claim 5, further including a dilator wedge splitter disposed within the catheter housing and configured split the dilator along the longitudinal axis.

### Claim 8 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing includes a flexible section configured to elastically deform along an axis extending perpendicular to the longitudinal axis.

### Claim 9 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing includes an aperture extending through a side wall of the catheter housing and including a flexible film barrier disposed thereover.

### Claim 10 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing includes a pleated section transitionable along the longitudinal axis between an extended configuration and a collapsed configuration.

### Claim 11 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing is configured to rotate about the longitudinal axis to detach from the needle housing and split the needle housing along a longitudinal axis.

### Claim 12 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing includes a blood flash indicator releasably coupled to a proximal end thereof.

### Claim 13 (depends on 1)

The catheter placement system according to claim 1, wherein the catheter housing includes a guidewire housing extending from a proximal end thereof and configured to receive a portion of a guidewire therein.

### Claim 14 (depends on 13)

The catheter placement system according to claim 13, wherein a portion of one of the housing or the guidewire housing includes transparent material.

### Claim 15

A method of placing a catheter, comprising:
providing a catheter placement system comprising:
a catheter housing including a flexible section and a pleated section;
an elongate medical device, a portion thereof disposed within the catheter housing; and
a needle housing releasably coupled to a distal end of the catheter housing and including a needle extending therefrom;
accessing a vasculature of a patient;
deforming the flexible section to grasp the portion of the elongate medical device disposed therebelow;
transitioning the pleated section between an extended configuration and a collapsed configuration;
releasing the flexible section to release the portion of the elongate medical device; and
transitioning the pleated section between a configuration and an extended configuration.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the elongate medical device includes one of a dilator, a catheter, or a guidewire.

### Claim 17 (depends on 15)

The method according to claim 15, further including compressing a blood flash indicator to draw a fluid flow through the needle and confirm vascular access.

### Claim 18 (depends on 15)

The method according to claim 15, further including:
deforming a distal flexible section to grasp a first portion of the elongate medical device;
transitioning the pleated section from the extended configuration to the collapsed configuration;
deforming a proximal flexible section to grasp a second portion of the elongate medical device;
releasing the first flexible section; and
transitioning the pleated section from the collapsed configuration to the extended configuration to withdraw the elongate medical device proximally.

### Claim 19 (depends on 15)

The method according to claim 15, further including withdrawing the elongate medical device proximally, over a splitter disposed within the housing to split the elongate medical device along a longitudinal axis.

### Claim 20 (depends on 15)

The method according to claim 15, further including actuating a needle retraction mechanism to retract the needle into the needle housing.

### Claim 21 (depends on 20)

The method according to claim 20, wherein actuating the needle retraction mechanism includes rotating a needle retraction lever that is hingedly coupled to the needle housing, the needle retraction lever actuating a gear mechanism within the needle retraction mechanism.

### Claim 22 (depends on 20)

The method according to claim 20, wherein retracting the needle into the needle housing includes splitting the needle along a longitudinal axis and rolling up the needle about an axis extending perpendicular to the longitudinal axis.

### Claim 23 (depends on 15)

The method according to claim 15, further including rotating the catheter housing to detach the catheter housing from the needle housing.

### Claim 24 (depends on 23)

The method according to claim 23, wherein detaching the catheter housing from the needle housing includes splitting the needle housing along a longitudinal axis to separate a first portion of the needle housing from a second portion of the needle housing.

### Claim 25 (depends on 24)

The method according to claim 24, further including attaching a connector set to a hub of the catheter.

### Claim 26 (depends on 25)

The method according to claim 25, wherein coupling the connector set to the catheter hub includes one of an interference fit, a push fit, a snap fit, a threaded engagement, or a bayonet fitting.
