FLOW CONTROL METHOD AND DEVICE

• US 20110130701A1
• Filed: 01/31/2011
• Published: 06/02/2011
• Est. Priority Date: 07/19/1999
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan Medical SA (Abbvie Incorporated)
• Inventors: Stergiopulos, Nikos
• Granted Patent: US 8,932,247 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae

Abstract

An arterio-venous graft (16) is provided with a constriction device (20) near its arterial end. The constriction device (20) is used to reduce the flow through the AV graft under normal conditions and to relieve the constriction when high flow through the AV graft is required, such as for vascular access for hemodialysis.

Claims

1. A device for controlling fluid flow in a vessel that is part of a digestive tract of a human, the device comprising:

an implantable housing;

a motor disposed within the implantable housing;

a drive shaft coupled to the motor; and

a transmission coupled to the drive shaft, the transmission configured to convert a rotation of the drive shaft for controlling a linear motion of a constriction applicator, the constriction applicator configured to control the fluid flow in the vessel based on the linear motion.

2. The device of claim 1 wherein the constriction applicator includes:

a first member configured to be move linearly in a direction substantially perpendicular to the fluid flow in the vessel; and

a second member coupled to the first member, the second member configured to apply an increasing amount of pressure as the first member is driven away from the transmission and toward the vessel.

3. The device of claim 2 wherein the constriction applicator further includes a third member forming an outer surface or an outer edge of the housing.

4. The device of claim 3 wherein the first member is a rod, the second member is a bar and the third member is a fine titanium membrane.

5. The device of claim 1 wherein the motor is an electrical micromotor.

6. The device of claim 5 wherein the electrical micromotor is configured to be able to drive the shaft in both a first direction and a second direction.

7. The device of claim 1 wherein the electrical micromotor is configured to be able to drive the shaft in only one direction.

8. The device of claim 7 wherein the constriction applicator is configured to perform a periodic displacement.

9. The device of claim 1 further comprising a receiver disposed within the implantable housing, the receiver coupled to the constriction applicator to selectively adjust a degree of constriction applied by the constriction applicator.

10. The device of claim 9 further comprising an external control device configured to transmit a telemetric signal to the receiver to control operation of the constriction applicator.

11. A device for controlling fluid flow in a vessel in a digestive tract of a human, the device comprising:

an implantable enclosure;

an actuator disposed within the implantable enclosure, the actuator configured to engage and to adjustably constrict the vessel, the actuator including;

a rotatable member coupled to a drive shaft of an electrical micromotor via a rotary to linear transmission, and

a receiver disposed within the implantable enclosure, the receiver coupled to the actuator to selectively adjust a degree of constriction applied by the rotatable member; and

an external control device configured to telemetrically supply a signal to the receiver to control operation of the actuator.

12. The device of claim 11 further comprising an antenna coupled to the receiver for receiving signals from the external control device.

13. The device of claim 12 wherein the receiver includes a converter for converting radio frequency energy received by the antenna into energy for powering the electrical micromotor.

14. The device of claim 12 further comprising a sensor for sensing the state of the actuator, the sensor configured to transmit a signal via the antenna indicating the sensed state.

15. The device of claim 12 further comprising at least one sensor for sensing at least one of pressure, flow rate or turbulence, the sensor configured to transmit a corresponding signal via the antenna.

16. The device of claim 15 wherein the sensor is configured to measure at least one of flow rate, turbulence or pressure.

17. The device of claim 16 wherein the sensor includes at least one of a Doppler device, a phonoangiographer or an electromagnetic flow sensor.

18. The device of claim 11 further comprising a battery.

19. The device of claim 11 wherein the actuator further includes a flexible membrane for pressing on the vessel.

20. The device of claim 19 wherein the membrane includes at least one corrugation.

21. The device of claim 11 wherein the actuator is arranged to constrict the vessel non-uniformly around its transverse cross-sectional periphery.

22. The device of claim 11 wherein the actuator is shaped to define a predetermined profile for the constriction.

23. The device of claim 11 further comprising a plurality of actuators.

24. The device of claim 23 wherein the plurality of actuators are arranged to constrict the vessel along an elongate portion thereof.

25. The device of claim 24 wherein the plurality of actuators control the profile of the constriction along its length.

26. The device of claim 23 wherein the plurality of the actuators control the profile of the constriction around the transverse cross-sectional periphery of the vessel.

27. The device of claim 21 wherein the implantable enclosure includes a titanium or ceramic implantable enclosure.

28. The device of claim 21 further comprising an implantable vessel graft.

29. The device of claim 28 wherein the actuator is adhered to the vessel graft to prevent uncontrolled constriction of the vessel graft.

30. The device of claim 29 wherein the constriction is shaped to resist further buckling under reduced pressure.

31. The device of claim 28 wherein the actuator is positioned at the upstream end of the vessel graft.

32. The device of claim 28 further comprising a deformable, but substantially incompressible, medium at least partially surrounding the vessel graft at the location of the actuator.

33. The device of claim 28 wherein a first end of the vessel graft is connected to an artery and a second end of the vessel graft is connected to one of an artery or a vein.

34. The device of claim 11 further comprising a measuring device coupled to the drive shaft to count a number of revolutions of the drive shaft.

35. The device of claim 34 wherein the measuring device is configured to transmit a signal to the external control device indicating the state of the drive shaft.

36. The device of claim 11 wherein the actuator is configured to squeeze the vessel by applying force at one or more points around the periphery of the vessel in a non-uniform manner.

37. The device of claim 11 wherein the actuator is configured to maintain substantially constant the length of the perimeter of the vessel in transverse cross-section, whilst adjusting the cross-sectional area of the lumen of the vessel.

38. The device of claim 11 wherein the actuator is configured to maintain constriction at a level such that a flow rate through the vessel is below onset of turbulence.

39. The device of claim 11 wherein the device is configured for use in the treatment of obesity.

40. The device of claim 11 wherein the device is configured for use in causing weight loss for the human.

41. The device of claim 11 wherein the vessel in the digestive tract is connected to a stomach of the human.

42. A method of fluid flow control in a vessel in a digestive tract of a human, the method comprising:

providing an implantable housing for a motor coupled to a drive shaft and a transmission;

driving the motor to rotate the drive shaft; and

converting, at the transmission, a rotation of the drive shaft to produce a linear motion of a constriction applicator configured to control the fluid flow in the vessel.

43. The method of claim 42 further comprising:

receiving a telemetric signal from an external control device, and in response to the telemetric signal being received, selectively adjusting a degree of constriction applied by the constriction applicator.

44. A method of fluid flow control in a vessel in a digestive tract of a human, the method comprising:

providing an implantable enclosure housing an actuator configured to engage and to adjustably constrict the vessel, the actuator including a rotatable member coupled to a drive shaft of an electrical micromotor via a rotary to linear transmission, a receiver disposed within the implantable enclosure and coupled to the actuator to selectively adjust a degree of constriction applied by the rotatable member responsive to a signal received from an external control;

providing an external control device configured to telemetrically supply a signal to the receiver to control operation of the actuator;

implanting the implantable enclosure so that the actuator engages the vessel; and

operating the external control device to selectively constrict the vessel.

45. The method of claim 44 wherein the external control device is operated so that the actuator applies constriction over an elongate portion of the vessel.

46. The method of claim 45 wherein the external control device is operated so that the actuator constricts the vessel at a plurality of positions along the vessel.

47. The method of claim 45 wherein the external control device is operated so that the actuator constricts the vessel so as to reduce the cross-sectional area of a lumen of the vessel at the constriction, while substantially maintaining the length of the perimeter of the vessel.

48. The method of claim 44 wherein the vessel in the digestive tract is connected to a stomach of the human.