# US 9,039,652 B2 · Apparatus and methods for treating intracorporeal fluid accumulation

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- Number: US 9,039,652 B2
- Document ID: US9039652B2
- Status: Granted
- Kind: B2
- Application number: 13/397,523
- Filed: 2012-02-15
- Published: 2012-08-16
- Granted: 2015-05-26
- Earliest claimed: 2011-02-16
- Assignees: Sequana Medical AG
- Applicants: Thomas Werner Degen; Daniel Thomas Thommen; Noel L. Johnson
- Inventors: Thomas Werner Degen; Daniel Thomas Thommen; Noel L. Johnson
- Web page: https://patentgrep.com/patent/US9039652B2

## CPC

- A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 5/14236: {Screw, impeller or centrifugal type pumps}
- A61M 5/14276: {specially adapted for implantation}
- G16H 40/63: for local operation
- A61M 2205/10: with powered movement mechanisms
- A61M 2205/3368: Temperature
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/3507: with implanted devices, e.g. external control
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8243: by induction
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/42: Rate
- G16H 20/17: delivered via infusion or injection
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A fluid management system for the treatment of ascites, pleural effusion or pericardial effusion is provided including an implantable device including a pump, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve performance data; and monitoring and control software, suitable for use with conventional personal computers, for configuring and controlling operation of the implantable device and charging and communication system. The implantable device includes a number of features that provide automated movement of fluid to the bladder with reduced risk of clogging, with no patient involvement other than occasional recharging of the battery of the implantable device. The monitoring and control software is available only to the treating physician, such that the physician interacts with the implantable device via the charging and communication system.

## Claims

### Claim 1

A fluid management system comprising:
an implantable device comprising a gear pump coupled to an electric motor, a first controller;
an inflow catheter having an inlet end and an outlet end configured to be coupled to the gear pump; and
an outflow catheter having an inlet end configured to be coupled to the gear pump and an outlet end configured to be positioned in a sink cavity,
wherein the first controller is programmed to selectively activate the gear pump to move fluid from the inlet end of the inflow catheter to the sink cavity during predetermined time periods, and to operate in a jog mode during such predetermined time periods, and to operate the motor and gear pump in a tick mode to reduce potential clogging, substantially without moving fluid to the sink cavity, during other predetermined time periods.

### Claim 2 (depends on 1)

The fluid management system of claim 1 wherein the first controller is programmed to automatically activate the gear pump to move fluid at high flow rates during pumping, and thereby clean the inflow and outflow catheters to reduce the risk of clogging.

### Claim 3 (depends on 1)

The fluid management system of claim 1 wherein during jog mode the first controller is programmed to operate the electric motor to unblock the gear pump by, rapidly alternating between forward and reverse directions.

### Claim 4 (depends on 1)

The fluid management system of claim 1 wherein the inlet end of the inflow catheter is configured to be positioned within a peritoneal cavity, the outlet end of the outflow catheter is configured to be positioned in a bladder, and the first controller is programmed to activate the gear pump to move ascites from the peritoneal cavity to the bladder.

### Claim 5 (depends on 1)

The fluid management system of claim 1 wherein the inlet end of the inflow catheter is configured to be positioned within a pleural cavity, the outlet end of the outflow catheter is configured to be positioned in either a bladder or a peritoneal cavity, and the first controller is programmed to activate the gear pump to move excess fluid from the pleural cavity to the bladder or peritoneal cavity.

### Claim 6 (depends on 1)

The fluid management system of claim 1 wherein the inlet end of the inflow catheter is configured to be positioned within a pericardial cavity, the outlet end of the outflow catheter is configured to be positioned in either a bladder or a peritoneal cavity, and the first controller is programmed to activate the gear pump to move excess fluid from the pericardial cavity to the bladder or peritoneal cavity.

### Claim 7 (depends on 1)

The fluid management system of claim 1 wherein the electric motor includes a splined shaft, the gear pump includes a gear having keyed opening, and the splined shaft floats within the keyed opening.

### Claim 8 (depends on 1)

The fluid management system of claim 1 wherein the implantable device further comprises a first pressure sensor configured to measure inflow catheter pressure and a second pressure sensor configured to measure outflow catheter pressure.

### Claim 9 (depends on 8)

The fluid management system of claim 8 wherein the implantable device further comprises a third pressure sensor configured to measure ambient pressure, and the first controller is programmed to activate the motor and gear pump responsive to differences between inflow catheter pressure and ambient pressure, and outflow catheter pressure and ambient pressure.

### Claim 10 (depends on 1)

The fluid management system of claim 1 wherein the implantable device further comprises at least one valve that prevents reverse flow from the outflow catheter to the inflow catheter.

### Claim 11 (depends on 10)

The fluid management system of claim 10 wherein the valve is interposed between two pressure sensors, such that a flow rate may be computed by measuring a pressure drop across the valve.

### Claim 12 (depends on 1)

The fluid management system of claim 1 further comprising an accelerometer disposed within the implantable device and coupled to the first controller, the first controller programmed to prevent activation of the motor and gear pump if the accelerometer indicates that a patient is asleep.

### Claim 13 (depends on 1)

The fluid management system of claim 1 wherein the implantable device further comprises a battery, a first transceiver, and a first inductive charging circuit coupled to the first controller and the fluid management system further comprises:
a charging and communication system comprising a second controller coupled to a second transceiver and a second inductive charging circuit, the charging and communication system configured to wirelessly communicate with the implantable device via the first and second transceivers, and to wirelessly transfer energy from the second inductive circuit to the first inductive circuit to charge the first battery.

### Claim 14 (depends on 13)

The fluid management system of claim 13 wherein the charging and communication system further comprises:
a handpiece housing the second controller, the second transceiver, the second inductive charging circuit and a second battery; and
a base containing circuitry for charging the second battery.

### Claim 15 (depends on 13)

The fluid management system of claim 13 wherein the second inductive circuit includes a coil, and the handpiece is configured to facilitate externally positioning the handpiece in alignment with the implantable device.

### Claim 16 (depends on 13)

The fluid management system of claim 13 wherein the first controller further is programmed to operate the electric motor and gear pump in a boost mode to unblock the gear pump, wherein additional energy to drive the electric motor is transferred to the first inductive circuit via the second inductive circuit of the charging and communication system.

### Claim 17 (depends on 13)

The fluid management system of claim 13 wherein the charging and communication system is configured to manually activate the pump and receive test data during a self-prime mode of operation.

### Claim 18 (depends on 13)

The fluid management system of claim 13 wherein the charging and communication system is configured to wirelessly download data stored on the implantable device to a memory disposed within the charging and communication system via the first and second transceivers.

### Claim 19 (depends on 13)

The fluid management system of claim 13 wherein the implantable device further comprises a temperature sensor coupled to the first controller to generate a temperature value, the second controller programmed to retrieve the temperature value from the implantable device while wirelessly transferring energy from the second inductive circuit to the first inductive circuit to charge the first battery.

### Claim 20 (depends on 19)

The fluid management system of claim 19 wherein the second controller is programmed to alternate wirelessly transferring energy from the second inductive circuit to the first inductive circuit between a high power mode and a low power mode to maintain the temperature value less than a predetermined value.

### Claim 21 (depends on 13)

The fluid management system of claim 13, further comprising:
a non-transitory computer readable medium programmed with instructions that, when run on a computer, cause the computer to communicate operational parameters to the implantable device via the charging and communication system to control operation of the electric motor and gear pump.

### Claim 22 (depends on 21)

The fluid management system of claim 21 wherein the first controller is programmed to automatically activate the motor and gear pump to move fluid during predetermined time periods and in predetermined volumes responsive to operational parameters communicated by the computer.

### Claim 23 (depends on 21)

The fluid management system of claim 21 wherein the charging and communication system is configured to wirelessly download data stored on the implantable device to a memory disposed within the charging and communication system via the first and second transceivers, and the instructions cause the computer to periodically communicate with the charging and communication system to retrieve the data stored in the memory.

### Claim 24 (depends on 21)

The fluid management system of claim 21 wherein the instructions cause the computer to upload revised firmware for the first controller via the charging and communication system using the first and second transceivers.

### Claim 25 (depends on 21)

The fluid management system of claim 21, wherein the implantable device further comprises a sensor configured to measure at least one of respiratory rate, fluid temperature, and fluid viscosity, and
wherein the instructions cause the computer to predict or detect infection based on an increase in at least one of the measured respiratory rate, fluid temperature, or fluid viscosity above a predefined threshold, and to visually display to a user to the prediction or detection of infection.