Systems and methods for monitoring and controlling internal pressure of an eye or body part

• US 9,381,301 B2
• Filed: 04/25/2007
• Issued: 07/05/2016
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Eastern Virginia Medical School
• Original Assignee: Eastern Virginia Medical School
• Inventors: Lattanzio, Frank A., Delahanty, Thomas C.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US12/298,485
• Publication Number:
  US 20090275924A1
• Time in Patent Office: 3,359 Days
• Field of Search: 600/398, 600/405, 600/406, 600/561, 604/540, 604/541, 604/9
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/28 Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83
• CPC Class Codes: A61M 5/16804 Flow controllers

Abstract

Systems and methods for automatically monitoring and controlling pressure in a body part are disclosed. The systems include an implantable tube with one open end of the tube implanted in the body part, an implantable valve coupled with the tube having at least one open state and a closed state, an implantable sensor for measuring pressure, and an implantable control device coupled with the sensor and the valve. The control device switches the valve between the at least one open state and the closed state, based on pressure information received from the sensor. When the valve is in the at least one open state, the tube drains fluids from the body part due to a difference of pressure between the open ends of the tube. Methods for using the systems to administer drugs and monitor and control fluid pressures in various biological systems are also disclosed.

Claims

1. A system for controlling pressure in a body part, comprising:

an implantable tube, having a first open end and a second open end, the first open end configured to be disposed in a body part;

an implantable valve coupled to the second open end of the tube and having at least one open state and a closed state wherein the valve further comprises an implantable sleeve having first and second ends and having an orifice extending through a wall of the sleeve, and a blade positioned inside said sleeve, and formed at least in part from a material that is reactive to magnetic force, the blade configured to slide from a first position relative to the sleeve where the blade does not block the orifice and the valve is in the at least one open state, to a second position relative to the sleeve where the blade blocks the orifice and the valve is in at least one closed state, such that a position of the blade relative to the sleeve determines whether the valve is in the at least one open state or the closed state;

a first implantable sensor for actively obtaining at least one measurement of pressure within the body part; and

an implantable control device electrically coupled with the valve and the sensor, for receiving the at least one measurement and switching the valve between the at least one open state and the closed state based on the at least one measurement,

wherein the tube is configured to drain fluids from the body part when the valve is in the at least one open state, due to a difference of pressure between the first and the second open end of the tube, the difference created by native differences in pressure of the body part to another body part.

2. The system of claim 1, wherein the sensor comprises a piezoresistive transducer.

3. The system of claim 1, wherein the sensor comprises a fiber optic sensor.

4. The system of claim 1, wherein the valve can be switched between the at least one open state and the closed state by an external magnet or piezoelectric device.

5. The system of claim 1, wherein the valve comprises at least one electromagnet, and the control device switches the valve between the at least one open state and the closed state by polarizing the at least one electromagnet.

6. The system of claim 5, wherein the valve further comprises:

the implantable blade having a first magnetic end and a second magnetic end, and

a second implantable sensor for verifying the position of the blade.

7. The system of claim 1, wherein the valve comprises a rotating member having one or more orifices.

8. The system of claim 1, wherein the control device comprises a wireless communication module for transmitting information to an external device.

9. The system of claim 1, wherein the control device comprises a two-way wireless communication module for transmitting and receiving information to and from an external device.

10. The system of claim 9, wherein the control device switches the valve between the at least one open state and the closed state according to at least one set point, the at least one set point being configurable by the external device.

11. The system of claim 1, wherein the control device comprises:

a battery; and

an electromagnetic induction system configured to recharge the battery.

12. The system of claim 1, wherein the sensor is further configured to obtain a temperature measurement, and the control device is further configured to receive the temperature measurement and switch the valve based on the pressure and the temperature measurements.

13. The system of claim 1, wherein the valve has at least two open states and drains fluids within a body part at different rates in different open states.

14. The system of claim 1, further comprising an implantable pump configured to deliver drugs into the body part.

15. The system of claim 1, wherein the control device further comprises a power source.

16. The system of claim 1, wherein the body part is an eye.

17. A system for controlling pressure in a body part, comprising:

an implantable tube, having a first open end and a second open end, the first open end configured to be disposed in a body part;

an implantable valve coupled to the second open end of the tube and having at least one open state and a closed state wherein the valve further comprises an implantable sleeve having first and second ends made from a material that is reactive to magnetic force and having an orifice extending through a wall of the sleeve, and a blade positioned inside said sleeve, and formed at least in part from a material that is reactive to magnetic force, the blade configured to slide from a first position relative to the sleeve where the blade does not block the orifice and the valve is in the at least one open state, to a second position relative to the sleeve where the blade blocks the orifice and the valve is in at least one closed state, such that a position of the blade relative to the sleeve determines whether the valve is in the at least one open state or the closed state;

a first implantable sensor for actively obtaining at least one measurement of pressure within the body part; and

an implantable control device electrically coupled with the valve and the sensor, for receiving the at least one measurement and switching the valve between the at least one open state and the closed state based on the at least one measurement,

wherein the tube is configured to drain fluids from the body part when the valve is in the at least one open state, through use of an implantable pump in the device.

18. The system of claim 17, wherein the valve can be switched between the at least one open state and the closed state by an external magnet or piezoelectric device.

19. The system of claim 17, wherein the valve comprises at least one electromagnet, and the control device switches the valve between the at least one open state and the closed state by polarizing the at least one electromagnet.

20. The system of claim 19, wherein the valve further comprises:

the implantable blade having a first magnetic end and a second magnetic end, and

a second implantable sensor for verifying the position of the blade.

21. The system of claim 17, wherein the control device comprises:

a battery; and

an electromagnetic induction system configured to recharge the battery.

22. The system of claim 17, wherein the control device further comprises a power source.

23. The system of claim 17, wherein the body part is an eye.

24. A system for controlling pressure in a body part, comprising:

an implantable tube, having a first open end and a second open end, the first open end configured to be disposed in a body part;

an implantable valve coupled to the second open end of the tube and having at least one open state and a closed state;

wherein the valve comprises an implantable sleeve having a first and second opening;

wherein the valve further comprises a blade, comprised at least in part of a material reactive to magnetic force, and positioned inside said sleeve and configured to move relative to the sleeve, such that a position of the blade determines whether the valve is in the at least one open state or the closed state;

a first implantable sensor for actively obtaining at least one measurement of pressure within the body part; and

an implantable control device electrically coupled with the valve and the sensor, for receiving the at least one measurement and switching the valve between the at least one open state and the closed state based on the at least one measurement,

wherein the tube is configured to drain fluids from the body part when the valve is in the at least one open state, through use of an implantable pump in the device.

25. The system of claim 24, wherein the body part is an eye.

26. A system for controlling pressure in a body part, comprising:

an implantable tube, having a first open end and a second open end, the first open end configured to be disposed in a body part;

an implantable valve coupled to the second open end of the tube and having at least one open state and a closed state;

wherein the valve comprises an implantable sleeve having a first and second opening;

wherein the valve further comprises a blade, comprised at least in part of a material reactive to magnetic force, and positioned inside said sleeve and configured to move relative to the sleeve, such that a position of the blade determines whether the valve is in the at least one open state or the closed state;

a first implantable sensor for actively obtaining at least one measurement of pressure within the body part; and

an implantable control device electrically coupled with the valve and the sensor, for receiving the at least one measurement and switching the valve between the at least one open state and the closed state based on the at least one measurement,

wherein the tube is configured to drain fluids from the body part when the valve is in the at least one open state, due to a difference of pressure between the first and the second open end of the tube, the difference created by native differences in pressure of the body part to another body part.

27. The system of claim 26, wherein the body part is an eye.