# US 10,871,788 B2 · Systems, apparatus, and methods for reducing fluid pressure in a fluid line

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- Number: US 10,871,788 B2
- Document ID: US10871788B2
- Status: Granted
- Kind: B2
- Application number: 16/539,569
- Filed: 2019-08-13
- Published: 2020-02-13
- Granted: 2020-12-22
- Earliest claimed: 2018-08-13
- Assignees: 410 Medical, Inc.
- Applicants: 410 Medical, Inc.
- Inventors: Andrew Lane; Savannah Carlsen; Galen C. Robertson; Mark D. Piehl
- Web page: https://patentgrep.com/patent/US10871788B2

## CPC

- A61M 5/48: having means for varying, regulating, indicating or limiting injection pressure (A61M5/142 takes precedence {; monitoring pressure in infusion systems A61M5/16854})
- G05D 16/0655: {using one spring-loaded membrane}
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/484: {Regulating injection pressure}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- A61M 5/16877: {Passive flow controllers; Devices for setting a flow rate (clamp-type valves A61M39/28)}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2206/22: eliminating pulsatile flows, e.g. by the provision of a dampening chamber
- 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)}
- G05D: SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES

## Abstract

In some embodiments, a tube portion can be configured to be fluidically coupled to a patient access component. A source of pressurized fluid can be coupled to the tube portion and can be configured to deliver fluid to the tube portion at a source pressure. A fluid pressure regulating device can include an expandable reservoir and can be coupled to the tube portion such that the expandable reservoir is in fluidic communication with the tube portion. The fluid pressure regulating device can be configured such that, when fluid is delivered from the source of pressurized fluid to the lumen of the tube portion at the source pressure, the expandable reservoir of the fluid pressure regulating device can receive fluid such that the expandable reservoir of the fluid pressure regulating device expands and fluid is delivered from the lumen of the tube portion to the patient via the patient access component.

## Claims

### Claim 1

A system, comprising:
a tube portion having a first end, a second end, and defining a lumen extending from the first end to the second end, the second end configured to be coupled to a patient access component such that fluid can be delivered from the lumen of the tube portion to a patient via the patient access component;
a source of pressurized fluid coupleable to the first end of the tube portion and configured to deliver fluid to the lumen of the tube portion at a source pressure, the source of pressurized fluid including a fluid receptacle and a one-way valve configured such that fluid can flow from the fluid receptacle, through the one-way valve, and into the lumen of the tube portion and fluid is prevented from flowing from the lumen of the tube portion into the fluid receptacle of the source of pressurized fluid; and
a fluid pressure regulating device including an inner tube and an outer tube, the inner tube having a first end and a second end and defining a reservoir, the inner tube disposed within a lumen of the outer tube, the outer tube being expandable from a first configuration to a second configuration, the outer tube being resiliently biased toward the first configuration, the fluid pressure regulating device coupleable to the tube portion such that the source of pressurized fluid is in fluidic communication with the tube portion via the fluid pressure regulating device, the inner tube configured to expand from a first configuration in which the reservoir has a first volume to a second configuration in which the reservoir has a second volume greater than the first volume when a pressure of fluid within the reservoir increases, the inner tube being resiliently biased toward the first configuration, the inner tube configured to apply a force on the outer tube while transitioning from the first configuration of the inner tube to the second configuration of the inner tube to cause the outer tube to expand from the first configuration of the outer tube to the second configuration of the outer tube, the fluid pressure regulating device configured to deliver fluid having a pulsatile flow rate to the lumen of the tube portion, the fluid pressure regulating device configured such that, when fluid is delivered from the fluid receptacle of the source of pressurized fluid to the reservoir of the inner tube at the source pressure, the reservoir of the inner tube receives fluid such that the inner tube expands from the first configuration to the second configuration and fluid is delivered from the reservoir of the inner tube to the patient access component via the lumen of the tube portion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the source of pressurized fluid includes a reciprocating actuator configured to deliver a discrete volume of fluid from the fluid receptacle of the source of pressurized fluid with each cycle of the reciprocating actuator.

### Claim 3 (depends on 1)

The system of claim 1, wherein the fluid pressure regulating device is configured such that, when the source of pressurized fluid is not delivering fluid to the lumen of the tube portion and the reservoir of the inner tube of the fluid pressure regulating device has a volume greater than the first volume, the fluid pressure regulating device can deliver fluid from the reservoir, through the lumen of the tube portion, through the patient access component, and to the patient via decreasing the size of the reservoir of the fluid pressure regulating device such that fluid is expelled from the reservoir of the fluid pressure regulating device.

### Claim 4 (depends on 1)

The system of claim 1, wherein the tube portion can be a first tube portion and further comprising a second tube portion having a first end and a second end and defining a lumen extending from the first end to the second end, the first end of the second tube portion coupled to the source of fluid pressure and the second end of the second tube portion coupled to the fluid pressure regulating device, the first end of the first tube portion coupled to the fluid pressure regulating device and the second end of the second tube portion coupled to the patient access component.

### Claim 5 (depends on 1)

The system of claim 1, wherein the source of pressurized fluid is configured to alternate between an expulsion state in which the source of pressurized fluid expels fluid from the fluid receptacle of the source of pressurized fluid into the lumen of the tube portion and a drawing state in which the source of pressurized fluid draws fluid from a fluid source into the fluid receptacle of the source of pressurized fluid, the system being configured to deliver fluid to the patient via the patient access component during both the expulsion state and the drawing state of the source of pressurized fluid.

### Claim 6 (depends on 1)

The system of claim 1, wherein the patient access component includes at least one of a catheter, a needle, or a port.

### Claim 7 (depends on 1)

The system of claim 1, wherein
the outer tube has first end and a second end,
the first end of the inner tube being coupled to the first end of the outer tube via a first end connector, the second end of the inner tube being coupled to the second end of the outer tube via a second end connector, a sidewall portion of the inner tube being sufficiently compliant such that the inner tube is configured to expand laterally relative to a central axis of the inner tube when a pressure level of a fluid within the reservoir increases such that the reservoir has the second volume, and the sidewall portion being resiliently biased toward the first volume such that the inner tube is configured to apply a force to the fluid within the reservoir to expel the fluid from the reservoir as the pressure level of the fluid within the reservoir decreases.

### Claim 8 (depends on 7)

The system of claim 7, wherein an inner diameter of the inner tube in the first configuration is sufficiently small such that no air will be trapped in the reservoir during priming of the fluid pressure regulating device regardless of the orientation of the inner tube during priming.

### Claim 9 (depends on 1)

The system of claim 1, wherein the fluid pressure regulating device has a first spring rate when the inner tube is not in contact with the outer tube and a second spring rate greater than the first rate when the inner tube is in contact with the outer tube.

### Claim 10 (depends on 1)

The system of claim 1, wherein the reservoir is cylindrical in the first configuration of the inner tube.

### Claim 11 (depends on 1)

The system of claim 1, wherein a length from the first end to the second end of the inner tube is the same in the first configuration and the second configuration of the inner tube.

### Claim 12

A method, comprising:
expelling fluid from a fluid pressure source to a tube portion via a fluid pressure regulating device at a source pressure such that fluid is delivered to a patient via the tube portion at a first instantaneous flow rate and fluid is delivered into a reservoir of the fluid pressure regulating device, the fluid pressure regulating device coupled to the tube portion such that the reservoir of the fluid pressure regulating device is in fluidic communication with a lumen of the tube portion, the fluid pressure regulating device including an inner tube and an outer tube, the inner tube having a first end and a second end and defining the reservoir, the inner tube disposed within a lumen of the outer tube, the fluid delivered into the reservoir causing the inner tube to transition from a first configuration having a first volume to a second configuration having a second volume greater than the first volume, the inner tube configured to apply a force to the outer tube while transitioning from the first configuration of the inner tube to the second configuration of the inner tube to cause the outer tube to expand from a first configuration of the outer tube to a second configuration of the outer tube;
discontinuing the expelling of fluid from the fluid pressure source to the tube portion; and
allowing the fluid pressure regulating device to deliver fluid from the reservoir of the fluid pressure regulating device to the patient via the tube portion at a second instantaneous flow rate lower than the first instantaneous flow rate.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
drawing fluid from a fluid source into a fluid receptacle of the fluid pressure source while the fluid pressure regulating device delivers fluid from the reservoir of the fluid pressure regulating device to the patient via the tube portion.

### Claim 14 (depends on 13)

The method of claim 13, wherein drawing fluid from the fluid source includes translating a plunger of the fluid pressure source away from an outlet of the fluid pressure source, the outlet fluidically coupled to the lumen of the tube portion.

### Claim 15 (depends on 13)

The method of claim 13, further comprising, after drawing fluid from the fluid source into the fluid receptacle of the fluid pressure source while the fluid pressure regulating device delivers fluid from the reservoir of the fluid pressure regulating device to the patient, expelling fluid from the fluid pressure source to the tube portion via the fluid pressure regulating device at the source pressure such that fluid is delivered to the patient via the tube portion and fluid is delivered into the reservoir of the fluid pressure regulating device.

### Claim 16 (depends on 13)

The method of claim 13, wherein the volume of the reservoir of the fluid pressure regulating device transitions from the first volume to the second volume while fluid is expelled from the fluid pressure source to the tube portion, and the volume of the reservoir of the fluid pressure regulating device transitions from the second volume to the first volume while fluid is drawn from the fluid source into the fluid receptacle of the fluid pressure source.

### Claim 17 (depends on 13)

The method of claim 13, wherein the expelling of the fluid from the fluid pressure source and the drawing fluid from the fluid source into the fluid receptacle occur simultaneously.

### Claim 18 (depends on 12)

The method of claim 12, wherein expelling fluid from the fluid pressure source includes actuating an actuation mechanism of the fluid pressure source.

### Claim 19 (depends on 18)

The method of claim 18, wherein the expelling the fluid from the fluid pressure source includes actuating the actuation mechanism by hand.

### Claim 20 (depends on 19)

The method of claim 19, wherein the actuating the actuation mechanism by hand includes feeling tactile feedback that corresponds to a pressure of fluid within the fluid pressure regulating device.

### Claim 21 (depends on 12)

The method of claim 12, wherein expelling fluid from the fluid pressure source includes translating a plunger of the fluid pressure source toward an outlet of the fluid pressure source, the outlet fluidically coupled to the lumen of the tube portion.

### Claim 22 (depends on 12)

The method of claim 12, wherein discontinuing the expelling of fluid from the fluid pressure source includes releasing an actuation mechanism of the fluid pressure source.
