# US 12,178,971 B2 · Catheter device comprising a levering member

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- Number: US 12,178,971 B2
- Document ID: US12178971B2
- Status: Granted
- Kind: B2
- Application number: 17/768,425
- Filed: 2020-10-09
- Published: 2023-03-16
- Granted: 2024-12-31
- Earliest claimed: 2019-10-23
- Assignees: Anesteasy AB
- Applicants: Anesteasy AB
- Inventors: Ove Jonsson
- Web page: https://patentgrep.com/patent/US12178971B2

## CPC

- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61B 2017/3454: {Details of tips}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2039/062: {used with a catheter}
- A61M 2205/582: by tactile feedback
- A61M 2205/583: by visual feedback
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The disclosure relates to a catheter device (1) comprising a catheter (2), a hypodermic introducer needle (3) and a levering member (23) adapted to be removably attached to the catheter (2) and motion the catheter from a retracted proximal position to an advanced distal position in an axial direction in relation to the introducer needle (3). The catheter device further comprising indicators to indicate the catheter (2) being advanced a distance d corresponding to the length of a beveled tip (18) of the needle (3), and the catheter (2) being advanced a distance D corresponding to a length greater than the length of the beveled tip of the needle (3).

## Claims

### Claim 1

A catheter device (1) having an axis A-A, a lower side (L) adapted to face a patient, and an upper side (U) opposite the lower side (L) adapted to face away from the patient,
said catheter device (1) comprising a catheter (2) and a hypodermic introducer needle (3), the catheter (2) comprising an axially elongated housing (4) having a proximal open end (5) adapted to receive a coupling mechanism or a plug, said elongated housing (4) further comprising an internal passage (6), a connecting port (7) with an internal orifice (8) arranged on the upper side (U) of the catheter device (1), and protrusion members (15) on an outer surface of the proximal open end (5), said catheter (2) further comprising a flexible catheter tube (12) connected to the elongated housing (4), said flexible catheter tube (12) comprising a distal tip end (13) and a lumen (14), said lumen (14) being in fluid communication with the internal passage (6) of the elongated housing (4);
the introducer needle (3) comprising a proximal head (16), a hollow needle (17) having a distal beveled tip (18), and an extended portion (19,29) connecting the hollow needle (17) with the head (16) and adapted to engage with the proximal open end (5) of the catheter (2) when the introducer needle (3) is inserted into the catheter (2), said head (16) comprising an axial channel (20) in fluid communication with an interior of the hollow needle (17), a grip plate (21) arranged on the head (16) and extending in a direction perpendicular to an axial direction, and an engagement member (22) arranged on the grip plate (21) and protruding distally from said grip plate (21),
said catheter (2) and said introducer needle (3) being arranged such that when the introducer needle (3) is inserted into the catheter (2), the grip plate (21) is directed towards the upper side (U) of the catheter (2) and aligned with the connection port (7), and wherein the protrusion members (15) on the proximal open end (5) of the catheter (2) are adapted to engage with the engagement member (22) on the grip plate (21) to prevent the introducer needle (3) from rotating around the axis A-A in relation to the catheter (2),
the catheter device (1) further comprising a levering member (23) adapted to be removably attached to the catheter (2) and further adapted to motion the catheter (2) from a retracted proximal position to an advanced distal position in the axial direction in relation to the introducer needle (3), wherein, in the retracted proximal position, the beveled tip (18) of the introducer needle (3) protrudes from the distal tip end (13) of the catheter tube (12),
and wherein, in the advanced distal position, the beveled tip (18) of the introducer needle (3) is hooded by the catheter tube (12),
said catheter device (1) further comprising visual and/or tactile indicators on the grip plate (21) and/or on the extended portion (19, 29) to indicate at least one of
a) the catheter (2) being advanced a distance d, said distance d corresponding to a length of the beveled tip (18) of the introducer needle (3), and
b) the catheter (2) being advanced a distance D, said distance D corresponding to a distance greater than the length of the beveled tip (18) of the introducer needle (3).

### Claim 2 (depends on 1)

The catheter device (1) according to claim 1, wherein the levering member (23) comprises a levering arm (24) and a connector (25) for connecting with the catheter (2).

### Claim 3 (depends on 2)

The catheter device (1) according to claim 2, wherein said connector (25) further comprises engagement recesses (26) adapted to engage with the protrusions (15) on the proximal open end (5) of the catheter (2) to removably connect the levering member (23) to the catheter (2).

### Claim 4 (depends on 2)

The catheter device (1) according to claim 2, wherein the indicators comprise stop surfaces (35) arranged on the grip plate (21) such that the levering member (23) will engage with said stop surfaces (35), providing a tactile indication for the user.

### Claim 5 (depends on 4)

The catheter device (1) according to claim 4, wherein the stop surfaces (35) comprise grooves, protrusions or edges arranged on the grip plate (21).

### Claim 6 (depends on 4)

The catheter device (1) according to claim 4, wherein the levering arm (24) comprises an interacting member (27) adapted to interact with the stop surfaces (35) of the grip plate (21).

### Claim 7 (depends on 6)

The catheter device (1) according to claim 6, wherein the levering arm (24) has an L-like shape or a curved shape and is arranged on the catheter (2) such that the interacting member (27) comprises an angle of the L-like shape, a convex surface of the curved shape, or a ridge on said convex surface adapted to engage with the stop surfaces (35) of the grip plate (21).

### Claim 8 (depends on 4)

The catheter device (1) according to claim 4, further comprising an extended portion (29) of the introducer needle (3) provided with ribs (30) that circumvent the extended portion radially from the axis A-A, and the proximal open end (5) of the catheter (2) or the connector (25) of the levering member (23) is provided with a locking flange (32), adapted to engage with the ribs (30) on the extended portion (29) of the introducer needle (3) when the catheter (2) is motioned distally in relation to the introducer needle (3), the ribs (30) optionally being marked in order to indicate at least one of the positions of the beveled tip (18) of the introducer needle (3) in relation to the distal tip end (13) of the catheter tube (12).

### Claim 9 (depends on 2)

The catheter device (1) according to claim 2, wherein the indicators are arranged on the extended portion (19, 29) of the introducer needle (3).

### Claim 10 (depends on 9)

The catheter device (1) according to claim 9, wherein the extended portion (29) of the introducer needle (3) is provided with ribs (30) that circumvent the extended portion (29) radially from the axis A-A, and the proximal open end (5) of the catheter (2) or the connector (25) of the levering member (23) is provided with a locking flange (32) adapted to engage with the ribs (30) on the extended portion (29) of the introducer needle (3) when the catheter (2) is motioned distally in relation to the introducer needle (3), the ribs (30) being marked in order to indicate at least one of the positions of the beveled tip (18) of the introducer needle (3) in relation to the distal tip end (13) of the catheter tube (12).

### Claim 11 (depends on 10)

The catheter device (1) according to claim 10, wherein the extended portion (29) of the needle comprises a chamfered surface (31) along one side of the entire extended portion (29), leading to a cross-sectional U-shape of the extended portion (29).

### Claim 12 (depends on 10)

The catheter device (1) according to claim 10, wherein the indicators comprise markings of the ribs (30) that will correspond to the catheter (2) being advanced a specified distance, providing a visual indication for the user, in addition to a tactile indication provided by each rib (30) being pulled over and engaging with the locking flange (32).

### Claim 13 (depends on 2)

The catheter device (1) according to claim 2, wherein the levering arm (24) comprises a lug (33) and the elongated housing (4) of the catheter (2) or a proximal end of the connector (25) of the levering member (23) comprises a retainment element (34), said retainment element (34) being adapted to engage with the lug (33) such that the levering member (23) may reversibly lock the catheter device (1) in a fully advanced position.

### Claim 14 (depends on 1)

The catheter device (1) according to claim 1, wherein the levering member (23) interacts with the grip plate (21) of the introducer needle (3) to motion the catheter (2) to advance distally.

### Claim 15 (depends on 1)

The catheter device (1) according to claim 1, wherein the levering member (23) is adapted to be removably attached to the connecting port (7) of the catheter (2).

### Claim 16 (depends on 1)

The catheter device (1) according to claim 1, wherein a length of the extended portion (19, 29) of the introducer needle (3) is at least equal to, or larger than a total length that the levering member (23) will advance the catheter (2) when fully advanced.

### Claim 17 (depends on 1)

A method of placing a catheter (2) in a blood vessel in a patient using a catheter device (1) according to claim 1, the method comprising the steps of:
i. positioning the catheter device (1) against a skin of the patient, in a location where the catheter (2) is to be placed and advancing the catheter device (1) by a distal motion towards a subcutaneous blood vessel,
ii. stopping the distal motion when blood appears in the head (16) of the introducer needle (3), indicating that a blood vessel has been entered,
iii. motioning the levering member (23) towards the grip plate (21) while keeping the introducer needle (3) still,
iv. pressing the levering member (23) against the grip plate (21), thereby causing the levering member (23) to glide against the grip plate (21) towards the elongated housing (4), further causing the catheter (2) to move distally in relation to the introducer needle (3) that is kept still, until a first indicator is reached, indicating that the beveled tip (18) of the introducer needle (3) is hooded,
v. further motioning the catheter device (1) into the blood vessel,
vi. further motioning the levering member (23), while keeping the introducer needle (3) still, to further distally advance the catheter (2) into the blood vessel, in one or optionally more than one steps,
vii. attaching the catheter (2) against the skin of the patient by attachment members (11) upon full advancement of the catheter (2) in relation to the introducer needle (3) by use of the levering member (23),
viii. removing the introducer needle (3) and optionally the levering member (23) from the catheter device (1), and sealing the proximal open end (5) of the catheter (2) by use of a removable plug or by connection to an infusion device or the like.