Programmable shunt with electromechanical valve actuator

• US 9,925,360 B2
• Filed: 10/28/2011
• Issued: 03/27/2018
• Est. Priority Date: 06/29/2007
• Status: Active Grant

• Current Assignee: Integra LifeSciences Switzerland Sàrl
• Original Assignee: Integra LifeSciences Switzerland Sàrl
• Inventors: Ludin, Lev, Mauge, Christopher
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/284,272
• Publication Number:
  US 20120046596A1
• Time in Patent Office: 2,342 Days
• Field of Search: 604 8, 604 9, 604264
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

Devices and methods for regulating and directing bodily fluids from one region of a patient to another region are disclosed. In general, an apparatus is provided that can include an implantable shunt system and a system controller. The implantable shunt system can have an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator that can be adapted to adjust a resistance of the valve. The implantable shunt system can be in electrical communication with the system controller. The system controller can generally be adapted to receive a physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve. The apparatus can also include an external programming device that is in communication with the system controller.

Claims

1. An apparatus for shunting cerebrospinal fluid from a patient'"'"'s ventricular cavity, comprising:

an implantable shunt system having;

a valve for regulating the flow of cerebrospinal fluid, the valve having an adjustable pressure threshold at which fluid begins to flow through the valve;

a sensor for measuring a physiological characteristic of the patient'"'"'s ventricular cavity; and

an electromechanical valve actuator operatively associated with the valve to adjust the pressure threshold at which fluid begins to flow through the valve and to lock the valve in place so as to maintain a set pressure threshold; and

an implantable system controller in electrical communication with the implantable shunt system, wherein the controller receives the physiological characteristic of the patient'"'"'s ventricular cavity and is programmed to operate the electromechanical valve actuator based on the physiological characteristic received and adjusts the pressure threshold at which fluid begins to flow through the valve.

2. The apparatus of claim 1, further comprising an external programming device in communication with the system controller.

3. The apparatus of claim 2, wherein the external programming device includes a display for communicating the physiological characteristic of the patient to a user.

4. The apparatus of claim 3, wherein the external programming device includes a user input element, the external programming device being configured to communicate one or more instructions to the system controller based upon user input.

5. The apparatus of claim 1, wherein the valve is a ball valve.

6. The apparatus of claim 1, wherein the electromechanical valve actuator comprises a spring operatively associated with a pressure setting mechanism, and at least one selected from the group consisting of an electric motor, a solenoid, and a linear actuator mechanically coupled to the pressure setting mechanism to vary a pressure applied by the spring to thereby adjust the resistance of the valve.

7. The apparatus of claim 6, wherein the spring is a leaf spring.

8. The apparatus of claim 6, wherein the spring is a helical spring.

9. The apparatus of claim 6, wherein the pressure setting mechanism includes a motor driven rotor assembly adapted to adjust a resistance of the valve upon actuation of the motor.

10. The apparatus of claim 6, wherein the pressure setting mechanism includes a motor driven stop member, the stop member being adapted to apply a force to the spring to adjust a resistance of the valve.

11. The apparatus of claim 3, wherein the sensor element is a pressure sensor for detecting a cerebro-spinal fluid pressure.

12. The apparatus of claim 11, wherein the system controller includes a microprocessor for comparing the measured pressure detected by the sensor to a target pressure.

13. The apparatus of claim 12, wherein the system controller is configured to receive an input signal generated from the external programming device, the signal being representative of the target pressure.

14. The apparatus of claim 12, wherein the microprocessor is programmed to calculate a desired resistance for the valve to achieve the target pressure.

15. The apparatus of claim 1, wherein the controller is contained within the implantable shunt system.

16. The apparatus of claim 2, further comprising an antenna in electrical communication with the system controller for communicating with the external programming device.

17. The apparatus of claim 16, wherein the antenna is configured to communicate with the external programming device via RF communication.

18. The apparatus of claim 16, wherein controller and antenna are disposed on an implant separate from the implantable shunt system.

19. The apparatus of claim 1, wherein the implantable shunt system further includes a second sensor element for measuring an additional physiological characteristic, the second sensor element being configured to transmit data representing the measured value of the additional physiological characteristic to the system controller.

20. The apparatus of claim 1, wherein the implantable shunt system further includes a battery for powering the system.

21. The apparatus of claim 2, wherein the external programming device is adapted to power the implantable shunt system.