# US 2025/0144286 A1 · Transcutaneous device for removal of fluid from a body

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- Number: US 2025/0144286 A1
- Document ID: US20250144286A1
- Status: Published application
- Kind: A1
- Application number: 18/970,110
- Filed: 2024-12-05
- Published: 2025-05-08
- Earliest claimed: 2014-09-04
- Assignees: Safeguard Medical Holdco, LLC
- Applicants: Safeguard Medical Holdco, LLC
- Inventors: Keith Joseph Real; Malcolm Quentin Russell
- Web page: https://patentgrep.com/patent/US20250144286A1

## CPC

- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 17/3421: {Cannulas}
- A61B 17/3474: {Insufflating needles, e.g. Veress needles}
- A61B 17/3498: {Valves therefor, e.g. flapper valves, slide valves (haemostasis valves A61M39/06; check valves A61M39/24)}
- A61M 1/69: {Drainage containers not being adapted for subjection to vacuum, e.g. bags (devices worn by the patient for reception of urine A61F5/44)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 25/065: {Guide needles}
- A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00915: {for radioactive radiation}
- A61B 2017/3454: {Details of tips}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0069: {Tip not integral with tube}
- A61M 25/008: {Strength or flexibility characteristics of the catheter tip}
- A61M 25/0105: {Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B)}
- 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 2039/1044: {Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources}
- A61M 2210/1039: Lungs
- 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

A single step body insertion device contains a Veress needle 10 which penetrates the skin surface and relevant tissue layers to reach fluid and/or gases that need to be removed from the body. The device comprises a cannula shaft 2 with a tapered distal tip 3 and a proximal hub 4 with a side port 7 housing a one way low pressure cracking valve 8. The cannula shaft is of a polymeric material which is flexible and kink resistant. The device is used for the management of conditions such as pneumothoraxes and pleural effusions as well as other conditions that require release of fluid and/or gas from the body.

## Claims

### Claim 1

A method of removing fluid from a body during needle thoracentesis, the method comprising:
providing a needle having a tip for penetrating a skin surface of the body; providing a cannula, the cannula having:
a cannula shaft having a length and a longitudinal axis along the length thereof, the cannula shaft being flexible and kink resistant; and
a tapered tip projecting from a distal end of the cannula shaft, the tapered tip having a taper extending along an entire length of the tapered tip, the cannula shaft being more flexible than the tapered tip,
the cannula having a hub at a proximal end of the cannula shaft, the hub having a sealing valve aligned with the longitudinal axis of the cannula shaft for sealingly engaging the needle, and a side port;
attaching a three-way tap having a one-way low pressure cracking valve having a cracking pressure of less than 12 mbar, attaching a syringe to a second port of the three-way tap for removing fluids from the pleural space to resolve pneumothorax, and attaching a portable drainage bag to a third port of the three-way tap;
pumping fluids to the drainage bag using the syringe; and
bending the cannula shaft and taping the cannula shaft to the body.

### Claim 2 (depends on 1)

The method of claim 1, further comprising inserting the needle into the cannula shaft so that the tip of the needle protrudes from the tapered tip of the cannula.

### Claim 3 (depends on 1)

The method of claim 1, wherein the needle is adapted to extend through the cannula shaft, the tip of the needle extending from the tapered tip of the cannula to penetrate a skin surface of the body, and further comprising penetrating the skin surface of the body with the tip of the needle to facilitate delivery of the tapered tip of the cannula for fluid to be removed from the body through the cannula.

### Claim 4 (depends on 3)

The method of claim 3, further comprising removing the needle from the cannula before taping the cannula shaft to the body.

### Claim 5 (depends on 4)

The method of claim 4, wherein the needle is a Veress needle.

### Claim 6 (depends on 1)

The method of claim 1, wherein the one-way low pressure cracking valve is attached to a first port of the three-way tap.

### Claim 7 (depends on 1)

The method of claim 1, further comprising withdrawing a plunger of the syringe and depressing the plunger to deliver fluid to the drainage bag.

### Claim 8 (depends on 7)

The method of claim 7, further comprising a subsequent withdrawal of the plunger and subsequent depressing of the plunger to deliver additional fluid to the drainage bag.

### Claim 9 (depends on 1)

The method of claim 1, further comprising disposing the drainage bag in a carrier.

### Claim 10 (depends on 1)

The method of claim 1, wherein the cannula has a hub and further comprising detaching the needle from the cannula.

### Claim 11 (depends on 10)

The method of claim 10, wherein the needle has a hub detachably connectible to the hub of the cannula.

### Claim 12 (depends on 10)

The method of claim 10, wherein the hub of the cannula has a valve that seals when the needle is removed from the cannula.
