# US 2014/0194851 A1 · Flow Actuated Valve for Implantable Drug Delivery Device

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- Number: US 2014/0194851 A1
- Document ID: US20140194851A1
- Status: Published application
- Kind: A1
- Application number: 14/136,948
- Filed: 2013-12-20
- Published: 2014-07-10
- Earliest claimed: 2013-01-08
- Assignees: Flowonix Medical Incorporated
- Applicants: Flowonix Medical Incorporated
- Inventors: Paul BURKE; Steve ADLER; Benjamin PIECUCH; Steve HANTMAN
- Web page: https://patentgrep.com/patent/US20140194851A1

## CPC

- A61M 5/16881: {Regulating valves}
- A61M 5/14276: {specially adapted for implantation}
- A61M 2039/2413: {designed to reduce and or shut-off the flow when a certain maximum flow limit is exceeded}
- A61M 2039/242: {designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid}
- A61M 2039/2433: {Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc}
- A61M 2039/2466: {being fixed in its center}
- A61M 2039/2473: {Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element}
- 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)}

## Abstract

An “MRI-safe” implantable infusion apparatus and method that includes a flow actuated valve (FAV) that closes to prevent a free flow of infusate to a patient during an MRI procedure, and a release mechanism that opens the valve so that the device may return to normal operation following the MRI procedure. In this manner, patient safety is improved and the inconvenience of having to empty the pump reservoir before undergoing an MRI procedure may be avoided.

## Claims

### Claim 1

An implantable infusion apparatus, comprising:
an infusate reservoir;
a metering assembly configured to receive infusate from the reservoir and output a metered quantity of infusate at a first flow rate;
an outlet configured to deliver the metered quantity of infusate to a delivery site; and
a flow activated valve in a fluid path between the reservoir and the outlet, the flow activated valve configured to maintain an open position allowing infusate to flow through the valve at the first flow rate and to close when the rate of flow of the infusate through the valve exceeds a threshold flow rate that is greater than the first flow rate.

### Claim 2 (depends on 1)

The implantable infusion apparatus of claim 1, wherein the threshold flow rate corresponds to a flow rate indicative of an unrestricted flow of infusate from the infusate reservoir to the delivery site.

### Claim 3 (depends on 1)

The implantable infusion apparatus of claim 1, wherein the metering assembly comprises a valve accumulator pump comprising at least one solenoid valve.

### Claim 4 (depends on 1)

The implantable infusion apparatus of claim 1, further comprising:
a release mechanism that is operable to re-open the flow activated valve from a closed position.

### Claim 5 (depends on 1)

The implantable infusion apparatus of claim 1, wherein the flow activated valve comprises a housing containing a moveable valve member, wherein the flow activated valve is configured such that a fluid pressure in the housing when the flow rate of the infusate exceeds the threshold flow rate causes the movable valve member to contact against a valve seat and restrict the flow of infusate through the flow activated valve.

### Claim 6 (depends on 5)

The implantable infusion apparatus of claim 5, wherein the moveable valve member comprises a piston attached to a spring member.

### Claim 7 (depends on 5)

The implantable infusion apparatus of claim 5, wherein the moveable valve member comprises a spring diaphragm.

### Claim 8 (depends on 5)

The implantable infusion apparatus of claim 5, wherein the moveable valve member is biased away from the valve seat by a spring force.

### Claim 9 (depends on 8)

The implantable infusion apparatus of claim 8, wherein the spring force configured to sufficient to prevent the valve member from contacting the valve seat at the first flow rate of the infusate.

### Claim 10 (depends on 1)

The implantable infusion apparatus of claim 1, wherein the flow actuated valve comprises one or more of a ball valve, an umbrella valve, and a duck bill valve.

### Claim 11 (depends on 4)

The implantable infusion apparatus of claim 4, wherein the release mechanism is a passive release mechanism.

### Claim 12 (depends on 11)

The implantable infusion apparatus of claim 11, wherein the passive release mechanism comprises a restrictive flow path around or through the flow activated valve configured to bleed fluid pressure from an upstream side of the valve, thereby causing the valve to re-open.

### Claim 13 (depends on 12)

The implantable infusion apparatus of claim 12, wherein the flow activated valve comprises a moveable valve member within a housing having a fluid inlet and a fluid outlet, and the passive release mechanism comprises one or more of a porous material and a capillary tube that provides a restrictive flow path from the fluid housing to the fluid outlet.

### Claim 14 (depends on 13)

The implantable infusion apparatus of claim 13, wherein the one or more of a porous material and a capillary tube are located on the moveable member.

### Claim 15 (depends on 12)

The implantable infusion apparatus of claim 12, wherein the flow activated valve comprises a moveable valve member within a housing having a fluid inlet and a fluid outlet, and the passive release mechanism comprises at least one capillary tube having a first end in fluid communication with the fluid inlet and a second end in fluid communication with the fluid outlet configured so that the at least one capillary tube provides a restrictive flow path around or through the flow activated valve when the flow activated valve is in a closed position.

### Claim 16 (depends on 15)

The implantable infusion apparatus of claim 15, wherein the at least one capillary tube is located in at least one of the housing and an outer sleeve that surrounds the housing.

### Claim 17 (depends on 12)

The implantable infusion apparatus of claim 12, wherein the flow activated valve comprises a moveable valve member within a housing having a fluid inlet and a fluid outlet, and the passive release mechanism comprises at least one disk having at least one fluid channel in a surface of the disk and positioned such that a first end of the at least one fluid channel is in fluid communication with the fluid inlet and a second end of the fluid channel is in fluid communication with the fluid outlet configures so that the at least one fluid channel provides a restrictive flow path around or through the flow activated valve when the flow activated valve is in a closed position.

### Claim 18 (depends on 17)

The implantable infusion apparatus of claim 17, wherein the passive release mechanism comprises at least two bonded silicon disks, wherein the at least one fluid channel is formed on a surface of at least one of the disks using a MEMS-based technology.

### Claim 19 (depends on 12)

The implantable infusion apparatus of claim 12, wherein the flow activated valve comprises a housing having a moveable valve member having a first interfacing surface and a valve seat having a second interfacing surface, wherein the first interfacing surface contacts the second interfacing surface when the flow activated valve is in a closed position, and the passive release mechanism comprises a surface treatment configured on at least one of the first and second interfacing surfaces to provide a restrictive flow path between the interfacing surfaces.

### Claim 20 (depends on 4)

The implantable infusion apparatus of claim 4, wherein the release mechanism is an active release mechanism.

### Claim 21 (depends on 20)

The implantable infusion apparatus of claim 20, wherein the active release mechanism comprises a pressure relief chamber configured to be opened when the flow activated valve is closed to reduce fluid pressure from an upstream side of the valve, thereby causing the valve to re-open.

### Claim 22 (depends on 20)

The implantable infusion apparatus of claim 20, wherein the active release mechanism comprises an actuator configured to perturb an interface between a valve member and a valve seat of the flow activated valve configured to cause the valve to re-open.

### Claim 23 (depends on 22)

The implantable infusion apparatus of claim 22, wherein the actuator comprises at least one of a mechanical actuator, an ultrasonic actuator and a piezoelectric actuator.

### Claim 24 (depends on 4)

The implantable infusion apparatus of claim 4, further comprising:
a sensor configured to detect when the flow activated valve is closed, wherein the release mechanism is configured to be triggered in response to the sensor detecting that the flow activated valve is closed.

### Claim 25

A method of delivering infusate to a delivery site within a human or animal body using an implantable infusion apparatus, comprising:
flowing a metered quantity of infusate from an infusate reservoir through a flow activated valve to the delivery site at a first infusate flow rate; and
closing the flow activated valve to restrict the flow of infusate to the delivery site when a flow rate of the infusate through the flow activated valve exceeds a threshold flow rate that is greater than the first flow rate.

### Claim 26 (depends on 25)

The method of claim 25, further comprising:
reopening the flow activated valve; and
flowing a metered quantity of infusate through the flow activated valve to the delivery site.

### Claim 27 (depends on 26)

The method of claim 26, further comprising:
detecting that the flow activated valve is closed; and
waiting a pre-determined time duration before reopening the flow activated valve.

### Claim 28 (depends on 27)

The method of claim 27, wherein the pre-determined time duration is greater than a duration of an MRI procedure.

### Claim 29 (depends on 26)

The method of claim 26, further comprising:
detecting a presence of a magnetic field, wherein the flow activated valve is reopened when the magnetic field is no longer detected.

### Claim 30

An implantable infusion apparatus, comprising:
means for flowing a metered quantity of infusate from an infusate reservoir through a flow activated valve to the delivery site at a first infusate flow rate; and
means for closing the flow activated valve to restrict the flow of infusate to the delivery site when a flow rate of the infusate through the flow activated valve exceeds a threshold flow rate, greater than the first flow rate.

### Claim 31 (depends on 29)

The apparatus of claim 29, further comprising:
means for automatically re-opening the flow activated valve.
