IP Library › Granted Patent US 12,420,075
Granted Patent B2
US 12,420,075 · App. 16/879,925 · Granted Sep 23, 2025

Externally programable magnetic valve assembly and controller

Inventors: Carlos A. Hakim (Coconut Grove, FL); Jamil M. Hakim (Miami, FL)
Assignee: CEREDYN BIOTECHNOLOGY LLC
A61M39/24A61M27/006F16K31/047A61M2039/226A61M2039/2493A61M2205/32A61M2205/3317A61M2205/3344A61M2205/50A61M2205/8206
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Quick Facts
Patent No.
US 12,420,075
App. No.
16/879,925
Granted
Sep 23, 2025
Kind
B2
Abstract

An externally programmable shunt valve assembly that includes a motor having a rotor that is operable in response to an externally applied magnetic field and configured to increase or decrease the working pressure of the shunt valve assembly. The motor may further include a position sensing mechanism that allows a position of the rotor, and associated pressure setting of the valve, to be determined using an external magnetic sensor. In certain examples the motor further includes a mechanical brake that is magnetically operable between a locked position and an unlocked position and which, in the locked position, prevents rotation of the rotor.

Claims (48)

1. A kit for setting a pressure in a surgically-implantable shunt valve, the kit comprising:

a surgically-implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting of the valve assembly; and

a programmer device having at least one programmer magnet, the at least one programmer magnet being selectively movable and configured to actuate the magnetically operable motor to allow a user to adjust the pressure setting of the valve assembly to match a pressure setpoint of the programmer, the programmer device including

a housing,

a motor coupled to the housing, and

a magnet assembly coupled to the motor and configured to rotate with respect to the housing, the magnet assembly including at least one programmer magnet to apply the external magnetic field on the valve assembly,

the motor including a shaft having a driver gear,

the magnet assembly further including a magnet support having a bearing, a driven gear coupled to the driver gear, a magnetic bridging plate coupled to the magnet support, the at least one programmer magnet being coupled to the magnetic bridging plate,

wherein the at least one programmer magnet includes a permanent magnet.

2. The kit of claim 1 , wherein the programmer device further includes at least one of a user interface and at least one button to turn ON and OFF the programmer device.

3. The kit of claim 2 , wherein the user interface of the programmer device includes a first button to increase the pressure setpoint and a second button to decrease the pressure setpoint.

4. The kit of claim 2 , wherein the programmer device includes at least one start button to initiate the programming sequence.

5. The kit of claim 1 , wherein the programmer device includes software to control the movement of the at least one programmer magnet to achieve the proper programming sequence.

6. The kit of claim 1 , wherein the programmer device is configured to rotate the rotor of the valve device in a first direction to a lowest pressure setting prior to initiating a rotation of the rotor in a second, opposite direction to the selected pressure setting.

7. The kit of claim 1 , further comprising a monitor device configured to detect a pressure setting of the surgically-implantable valve assembly, wherein the monitor device includes at least one of a user interface and a button to turn ON and OFF the monitor device.

8. The kit of claim 1 , further comprising a monitor device configured to detect a pressure setting of the surgically-implantable valve assembly, wherein the monitor device includes a housing and a monitor assembly supported by the housing, the monitor assembly including at least one monitor sensor configured to center the monitor assembly and to detect a position of the magnetically operable motor of the valve assembly.

9. The kit of claim 8 , wherein the monitor sensor includes a first sensor to center the monitor assembly and a second sensor to detect a position of the magnetically operable motor of the surgically-implantable shunt valve assembly.

10. A kit for setting a pressure in a surgically-implantable shunt valve, the kit comprising:

a surgically-implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting of the valve assembly;

a monitor device configured to detect a pressure setting of the surgically-implantable valve assembly; and

a programmer device having at least one programmer magnet, the at least one programmer magnet being selectively movable and configured to actuate the magnetically operable motor to allow a user to adjust the pressure setting of the valve assembly to match a pressure setpoint of the programmer,

wherein the programmer device is separate from the monitor device, and

wherein the at least one programmer magnet includes a permanent magnet,

wherein the valve assembly includes a magnetically operated mechanical brake assembly including

an indicator having an indicator housing and a magnet disposed within the indicator housing, and

a brake coupled to the indicator and movable in response to movement of the indicator between a locked position in which the brake is positioned between teeth of a plurality of motor teeth to prevent rotation of a rotor of the motor and an unlocked position in which the brake disengages the teeth of the plurality of rotor teeth, the indicator being movable in response to being exposed to an external magnetic field applied by the programmer device, and

wherein the valve assembly further includes a housing, an exterior of the housing being formed of a physiologically-compatible material, and the magnetically operable motor disposed within the housing, the magnetically operable motor including a stator and the rotor, which is configured to rotate relative to the stator responsive to a changing magnetic polarity of the stator induced by the external magnetic field.

11. The kit of claim 10 , wherein the rotor includes a rotor casing and a plurality of rotor permanent magnet elements disposed in a ring within the rotor casing and arranged with alternating magnetic polarities, rotation of the rotor relative to the stator producing the selected pressure setting of the valve assembly, the rotor casing having the plurality of motor teeth.

12. The kit of claim 11 , wherein the valve assembly further includes an inlet port positioned between the rotor casing and an exterior of the housing, the inlet port terminating at its rotor casing end in a valve seat,

a spring,

a valve element biased against the valve seat by the spring, the valve element and the valve seat together forming an aperture, and

an outlet port positioned between the rotor casing and the exterior of the housing, the valve assembly configured such that the aperture opens when a pressure of the fluid in the inlet port exceeds the selected pressure setting of the valve assembly so as to vent fluid through the aperture into the outlet port.

13. The kit of claim 11 , wherein the valve assembly includes a rotor marker attached to the rotor such that the rotor marker rotates with the rotor and a housing marker fixedly attached to the housing, wherein a position of the rotor marker relative to the housing marker is indicative of the pressure setting of the valve assembly.

14. The kit of claim 1 , further comprising a positioning disk that is used to position the monitor device and optionally the programmer device on the valve assembly, wherein the positioning disk is separate from the monitor device and the programmer device.

15. A kit for setting a pressure in a surgically-implantable shunt valve, the kit comprising:

a surgically-implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting of the valve assembly; and

a programmer device having at least one programmer magnet, the at least one programmer magnet being selectively movable and configured to actuate the magnetically operable motor to allow a user to adjust the pressure setting of the valve assembly to match a pressure setpoint of the programmer, the programmer device including

a housing,

a motor coupled to the housing, and

a magnet assembly coupled to the motor and configured to rotate with respect to the housing, the magnet assembly including at least one programmer magnet to apply the external magnetic field on the valve assembly,

the motor including a shaft having a driver gear,

the magnet assembly further including a magnet support having a bearing, a driven gear coupled to the driver gear, a magnetic bridging plate coupled to the magnet support, the at least one programmer magnet being coupled to the magnetic bridging plate.

16. A kit for setting a pressure in a surgically-implantable shunt valve, the kit comprising:

a surgically-implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting of the valve assembly;

a monitor device configured to detect a pressure setting of the surgically-implantable valve assembly; and

a programmer device having at least one programmer magnet, the at least one programmer magnet being selectively movable and configured to actuate the magnetically operable motor to allow a user to adjust the pressure setting of the valve assembly to match a pressure setpoint of the programmer, the at least one programmer magnet including a permanent magnet,

wherein the valve assembly includes a magnetically operated mechanical brake assembly having a brake movable between a locked position in which the brake is positioned between teeth of a plurality of motor teeth to prevent rotation of a rotor of the motor and an unlocked position in which the brake disengages the teeth of the plurality of rotor teeth, and

wherein the valve assembly further includes a housing, an exterior of the housing being formed of a physiologically-compatible material, and the magnetically operable motor disposed within the housing, the magnetically operable motor including a stator and the rotor, which is configured to rotate relative to the stator responsive to a changing magnetic polarity of the stator induced by the external magnetic field.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 13, 2021
From: HAKIM, JAMIL M.
To: CEREDYN BIOTECHNOLOGY LLC
Reel/Frame 057784/0044 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 13, 2021
From: HAKIM, CARLOS A.
To: CEREDYN BIOTECHNOLOGY LLC
Reel/Frame 057784/0161 →
Continuity (3)
Continuation In Part 15675497 · Aug 11, 2017
Provisional Application 62374046 · Aug 12, 2016
Related Publication 20200282200A1 · Sep 10, 2020
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