# US 11,439,797 B2 · Surgical drain system and container

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- Number: US 11,439,797 B2
- Document ID: US11439797B2
- Status: Granted
- Kind: B2
- Application number: 15/879,034
- Filed: 2018-01-24
- Published: 2018-08-16
- Granted: 2022-09-13
- Earliest claimed: 2017-02-10
- Assignees: Medtronic Advanced Energy LLC
- Applicants: Medtronic Advanced Energy LLC.
- Inventors: Mark Guirguis; Nathan Zamarripa; Nicholas Valley; Christian Schasel
- Web page: https://patentgrep.com/patent/US11439797B2

## CPC

- A61M 27/00: Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202})
- A61M 1/60: {Containers for suction drainage, adapted to be used with an external suction source (containers not adapted for subjection to vacuum A61M1/69)}
- A61M 1/64: {Containers with integrated suction means (containers not adapted for subjection to vacuum A61M1/69)}
- A61M 1/66: {Pre-evacuated rigid containers, e.g. Redon bottles}
- A61M 1/70: {Gravity drainage systems (drainage containers not being adapted for subjection to vacuum A61M1/69)}
- A61M 1/72: {Cassettes forming partially or totally the fluid circuit}
- A61M 1/73: {comprising sensors or indicators for physical values}
- A61M 1/80: {Suction pumps (A61M1/64, A61M1/71, A61M60/00 take precedence)}
- A61M 1/86: {Connectors between drainage tube and handpiece, e.g. drainage tubes detachable from handpiece}
- A61M 1/90: {Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing}
- A61M 1/95: {with sensors for exudate composition}
- A61M 1/98: {Containers specifically adapted for negative pressure wound therapy}
- A61M 1/982: {with means for detecting level of collected exudate}
- A61M 1/984: {portable on the body}
- A61F 5/4404: {Details or parts}
- A61M 2205/103: rotating
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/18: with alarm
- A61M 2205/215: Tilt detection, e.g. for warning or shut-off
- A61M 2205/3306: Optical measuring means
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/8206: battery-operated
- A61M 2209/088: on the body
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site is disclosed. The container includes a drain hub having at least one sensor and a cartridge removably coupled to the drain hub in fluid communication with the drain to provide a suction source to draw and receive the fluid from the surgical site. The at least one sensor detects a characteristic of the fluid in the cartridge.

## Claims

### Claim 1

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub in fluid communication with the drain and having a side and at least one sensor, the side including a sensor window and the sensor being disposed proximate an interior of the side and the sensor window; and
a pumpless cartridge removably coupled to the drain hub in fluid communication with the drain via the drain hub to draw, against an exterior of the side, and receive the fluid from the surgical site via a one-way valve in the pumpless cartridge;
wherein the at least one sensor detects fluid color, fluid volume in the cartridge, and orientation of the container from outside of the cartridge, wherein the detection of fluid volume and fluid color are based on whether the container is detected in a selected orientation.

### Claim 2 (depends on 1)

The container of claim 1 wherein the drain hub includes a processing circuit configured to receive signals from the at least one sensor.

### Claim 3 (depends on 2)

The container of claim 2 wherein the drain hub includes a communications module operably couplable to a computing device via a wireless-network to exchange computer data between the processing circuit and the computing device.

### Claim 4 (depends on 2)

The container of claim 2 wherein the at least one sensor includes a plurality of sensors including an inertial motion sensor and a volume sensor.

### Claim 5 (depends on 4)

The container of claim 4 wherein the processing circuit is configured to receive a signal from the volume sensor when the container is in a selected orientation as determined from a signal from the inertial motion sensor.

### Claim 6 (depends on 5)

The container of claim 5 wherein the processing circuit is configured to provide an alert when the cartridge is full of fluid.

### Claim 7 (depends on 6)

The container of claim 6 wherein the cartridge is set at a prescribed pressure.

### Claim 8 (depends on 1)

The container of claim 1 wherein the drain hub includes a fluid pathway configured to be in fluid communication with the drain and the cartridge, wherein the fluid pathway includes a turbine configured to be rotated about an axis within the fluid pathway.

### Claim 9

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub having a top surface with a fluid port, a bottom surface, and a side surface of a plurality of side surfaces, the side surface having a sensor window, wherein the top surface, bottom surface and plurality of side surfaces defining an interior having at least one sensor proximate the sensor window; and
a generally rigid cartridge removably coupled to the drain hub in fluid communication with the drain to draw and receive the fluid from the surgical site, the generally rigid cartridge having a prescribed vacuity when installed into the drain hub proximate an exterior of the side surface, the generally rigid cartridge contained within the top surface, plurality of side surfaces, and bottom surface of the drain hub;
wherein the at least one sensor detects characteristics of the fluid in the cartridge without contacting the fluid, the detected characteristics including fluid volume and fluid color, wherein the detection of fluid volume and fluid color are based on whether the drain hub is detected in a selected orientation.

### Claim 10 (depends on 9)

The container of claim 9 wherein the cartridge includes a cover and the drain hub includes an article to pierce the cover when the cartridge is installed into the drain hub.

### Claim 11 (depends on 10)

The container of claim 10 wherein drain hub is in fluid communication with the drain.

### Claim 12 (depends on 11)

The container of claim 11 wherein the cartridge provides a source of negative pressure for the drain system when installed into the drain hub.

### Claim 13 (depends on 9)

The container of claim 9 wherein the cartridge includes a cover that is pierced by the drain hub when the cartridge is installed into the drain hub, the cover provided over an opening that is in fluid communication with the drain when the cartridge is installed into the drain hub.

### Claim 14 (depends on 9)

The portable surgical drain system of claim 9 wherein the at least one sensor includes an inertial motion sensor to detect orientation of the container.

### Claim 15 (depends on 9)

The portable surgical drain system of claim 9 including a processing circuit configured to receive signals from the at least one sensor.

### Claim 16

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub having a plurality of walls defining an exterior, the drain hub having at least one sensor being disposed within the plurality of walls; and
a generally rigid cartridge removably coupled to and against the drain hub in fluid communication with the drain to provide a suction source to draw and receive the fluid from the surgical site, the generally rigid cartridge contained within the walls defining the exterior of the drain hub;
wherein the at least one sensor detects a characteristic of the fluid in the container from outside of the cartridge, the detected characteristics including fluid color, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation.

### Claim 17 (depends on 16)

The container of claim 16 wherein the characteristic that the at least one sensor detects includes at least one of fluid color, fluid volume in the cartridge, and orientation of the container.

### Claim 18 (depends on 16)

The container of claim 16 wherein the suction source is a negative pressure.

### Claim 19 (depends on 18)

The container of claim 18 wherein the suction source is a prescribed vacuity in the cartridge.

### Claim 20 (depends on 16)

The container of claim 16 wherein the at least one sensor includes a volume sensor to detect fluid volume in the cartridge.

### Claim 21

A portable container for a surgical drain system to receive a fluid from a drain at a surgical site, the portable container comprising:
a drain hub having a plurality of sides defining an interior, the drain hub in fluid communication with the drain; and
a cartridge removably coupled to the drain hub in fluid communication with the drain to receive the fluid from the surgical site;
wherein the drain hub includes at least one sensor configured to fluid color, fluid volume in the cartridge, and orientation of the container from the interior of the drain hub and outside of the cartridge without contacting the fluid, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation; and
wherein the interior of the drain hub includes a fluid pathway configured to be in fluid communication with the drain and the cartridge, wherein the fluid pathway includes a turbine configured to be rotated about an axis within the fluid pathway, the turbine activated by differential pressure between the cartridge and the surgical site.

### Claim 22 (depends on 21)

The portable container of claim 21 wherein the drain hub includes a processing circuit configured to receive signals from the at least one sensor.

### Claim 23 (depends on 22)

The portable container of claim 22 wherein the drain hub includes a communications module operably couplable to computing device via a wireless-network to exchange computer data between the processing circuit and the computing device.

### Claim 24 (depends on 22)

The portable container of claim 22 wherein the at least one sensor includes a plurality of sensors including an inertial motion sensor and a volume sensor.

### Claim 25 (depends on 24)

The portable container of claim 24 wherein the processing circuit is configured to receive a signal from the volume sensor when the container is in a selected orientation as determined from a signal from the inertial motion sensor.

### Claim 26 (depends on 25)

The portable container of claim 25 wherein the processing circuit is configured to provide an alert when the cartridge is full of fluid.

### Claim 27 (depends on 21)

The portable container of claim 21 wherein the cartridge is set at a prescribed pressure.

### Claim 28

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub having a translucent window and at least one sensor disposed in the translucent window and an axial fluid pathway configured to be in fluid communication with the drain, the fluid pathway including a turbine configured to be rotated about an axis of rotation within the fluid pathway; and
a generally rigid cartridge removably coupled to the drain hub in fluid communication with the drain to draw and receive the fluid from the surgical site via the fluid pathway, the generally rigid cartridge having a prescribed vacuity when installed into the drain hub;
wherein the at least one sensor detects a characteristic of the fluid in the cartridge from outside of the cartridge through the translucent window without contacting the fluid, the detected characteristic including fluid color, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation, and the turbine is rotated by a force from the prescribed vacuity of the cartridge, and
wherein the turbine is activated by differential pressure between the cartridge and the surgical site.

### Claim 29 (depends on 28)

The container of claim 28 comprising a processing circuit operably coupled to the at least one sensor and configured to receive a signal from the at least one sensor wherein the processing circuit is configured to selectively provide a notification if a clog is determined in the drain system.

### Claim 30 (depends on 28)

The container of claim 28 wherein the turbine is configured as a hub having an axis corresponding with the axis of rotation of a plurality of fins radially extending from the hub.

### Claim 31 (depends on 30)

The container of claim 30 wherein the turbine is disposed within a lumen of the fluid pathway.

### Claim 32

A portable container for a surgical drain system to receive a fluid from a drain at surgical site of the surgical drain system, the portable container comprising:
a cartridge to draw and receive the fluid; and
a drain hub, the cartridge removably coupled to the drain hub, the drain hub including a fluid pathway in fluid communication with the cartridge and the drain, the drain hub comprising:
a sensor configured to detect fluid color via a translucent window and without contacting the fluid in the cartridge, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation;
a processing circuit operably coupled to the sensor and configured to receive signals from the sensor;
a communications module operably coupled to the processing circuit to transmit computer data received from the processing circuit to a computing device on over a wireless-network; and
a turbine disposed within the fluid pathway and operably coupled to the processing circuit wherein the processing circuit is configured to selectively operate the turbine if a clog is determined in the drain system, the turbine including coiled blades coupled to a rotating hub to generate a thrusting force in the fluid pathway.

### Claim 33 (depends on 32)

The portable container of claim 32 wherein the computing device is one of a mobile device and a network intermediary.

### Claim 34 (depends on 33)

The portable container of claim 33 wherein the computing device is operably coupled to a remote server and the processing circuit is configured to exchange computer data with the remote server via the communications module.

### Claim 35 (depends on 33)

The portable container of claim 33 wherein the mobile device is a smartphone.

### Claim 36 (depends on 32)

The portable container of claim 32 wherein the sensor is configured to inferentially detect fluid flow.

### Claim 37 (depends on 36)

The portable container of claim 36 wherein fluid flow is determined via change in fluid volume over a period of time.

### Claim 38 (depends on 32)

The portable container of claim 32 wherein the cartridge is generally rigid and includes a prescribed vacuity when installed into the drain hub.

### Claim 39

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub having a plurality of walls and a sensor being disposed within the plurality of walls;
a cartridge removably coupled to the drain hub in fluid communication with the drain to provide a suction source to draw and receive the fluid from the surgical site, the cartridge having an exterior wall disposed against the drain hub at a wall of the plurality of walls; and
a turbine including coiled blades coupled to a rotating hub, the turbine disposed in the drain hub to generate a thrusting force in a fluid pathway between the drain hub and the cartridge wherein the turbine is activated by differential pressure between the cartridge and the surgical site;
wherein the sensor detects a characteristic of the fluid in the container without contacting the fluid, and the cartridge is received within the walls of the drain hub, the detected characteristic including fluid color, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation.

### Claim 40 (depends on 39)

The container of claim 39 wherein the cartridge includes generally rigid walls and the suction source is a negative pressure.

### Claim 41 (depends on 40)

The container of claim 40 wherein the negative pressure is a prescribed vacuity.

### Claim 42 (depends on 39)

The container of claim 39 wherein the sensor is disposed within a wall of the plurality of walls of the drain hub.

### Claim 43 (depends on 42)

The container of claim 42 wherein the wall of the plurality of walls includes a translucent window proximate the sensor.

### Claim 44 (depends on 43)

The container of claim 43 wherein the cartridge includes generally translucent walls proximate the translucent window.

### Claim 45 (depends on 44)

The container of claim 44 wherein the translucent window and translucent walls of the cartridge are generally transparent.

### Claim 46 (depends on 42)

The container of claim 42 wherein the drain hub includes a processing circuit operably coupled to the sensor and configured to receive signals from the sensor, wherein the processing circuit is disposed within the wall of the drain hub.

### Claim 47 (depends on 46)

The container of claim 46 wherein the drain hub includes a communications module operably coupled to the processing circuit to transmit computer data received from the processing circuit, wherein the communication module is disposed with the wall of the drain hub.

### Claim 48 (depends on 46)

The container of claim 46 wherein the drain hub includes a plurality of sensors configured to detect fluid color, fluid volume in the cartridge, and orientation of the container, the plurality of sensors coupled to the processing circuit.

### Claim 49 (depends on 39)

The container of claim 39 wherein the cartridge is received entirely within the walls of the drain hub.

### Claim 50 (depends on 39)

The container of claim 39 wherein the characteristic of the fluid futher includes fluid volume.

### Claim 51

A container for a portable surgical drain system to receive a fluid from a drain at a surgical site, the container comprising:
a drain hub having a top receiver and a plurality of sides defining an interior, wherein the top receiver includes a drain connection and a fluid pathway configured to be in fluid communication with the drain, and wherein at least one of the plurality of sides includes a sensor window and a sensor within the interior proximate the sensor window; and
a cartridge removably coupled to the drain hub in fluid communication with the drain to provide a suction source to draw and receive the fluid from the surgical site, the cartridge disposed against the at least one side, the cartridge contained within the walls defining the interior of the drain hub; and
a turbine disposed in the drain hub to generate a thrusting force in the fluid pathway wherein the turbine is activated by differential pressure between the cartridge and the surgical site;
wherein the sensor detects a characteristic of the fluid in the container from outside of the cartridge, and the cartridge is received within the walls of the drain hub, the detected characteristic including fluid color, wherein the detection of fluid color is based on whether the drain hub is detected in a selected orientation.

### Claim 52 (depends on 51)

The container of claim 51 wherein the fluid pathway includes lumen, and the turbine is disposed within the lumen.

### Claim 53 (depends on 51)

The container of claim 51 wherein at least one of the plurality of sides includes a processing circuit operably coupled to the sensor and configured to receive signals from the sensor, and the top receiver includes a power source operably coupled to the processing circuit.

### Claim 54 (depends on 51)

The container of claim 51 wherein the plurality of sides are generally rigid and include a translucent window proximate the sensor.

### Claim 55 (depends on 54)

The container of claim 54 wherein the cartridge includes a plurality of translucent walls.

### Claim 56 (depends on 55)

The container of claim 55 wherein the plurality of walls are generally rigid.