Flow control method and device

• US 7,128,750 B1
• Filed: 07/19/2000
• Issued: 10/31/2006
• Est. Priority Date: 07/19/1999
• Status: Expired due to Term

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: EndoArt SA (Abbvie Incorporated)
• Inventors: Stergiopulos, Nikos
• Primary Examiner(s): Robert, Eduardo C.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US10/031,469
• Time in Patent Office: 2,295 Days
• Field of Search: 606/157, 606/158, 600 16- 18
• US Class Current: 606/158
• 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 flow in a bodily vessel, said device comprising:

an implantable enclosure;

an actuator disposed within the implantable enclosure, the actuator configured to engage and to adjustably constrict said bodily vessel, the actuator comprising 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, the receiver operatively 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; and

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

2. A device according to claim 1, further comprising an antenna coupled to the receiver for receiving signals from the external control device.

3. A device according to claim 2, wherein the receiver comprises a converter for converting radio frequency energy received by said antenna into energy for powering the electrical micromotor.

4. A device according to claim 2, further comprising a sensor for sensing the state of the actuator and transmitting a signal via said antenna indicative of said state.

5. A device according to claim 2, further comprising at least one sensor for sensing at least one of pressure, flow rate and turbulence and transmitting a corresponding signal via said antenna.

6. A device according to claim 5, wherein said sensor measures at least one of flow rate, turbulence and pressure.

7. A device according to claim 6, wherein said sensor comprises at least one of a Doppler device, a phonoangiographer and an electromagnetic flow sensor.

8. A device according to claim 1, further comprising a battery.

9. A device according to claim 1, wherein said actuator further comprises a flexible membrane for pressing on said bodily vessel.

10. A device according to claim 9, wherein said membrane comprises at least one corrugation.

11. A device according to claim 1, wherein said actuator is arranged to constrict said bodily vessel non-uniformly around its transverse cross-sectional periphery.

12. A device according to claim 1, wherein said actuator is shaped to define a predetermined profile for said constriction.

13. A device according to claim 1, further comprising a plurality of said actuators.

14. A device according to claim 13, wherein the plurality of said actuators are arranged to constrict said bodily vessel along an elongate portion thereof.

15. A device according to claim 14 wherein the plurality of said actuators control the profile of the constriction along its length.

16. A device according to claim 13 wherein the plurality of said actuators control the profile of the constriction around the transverse cross-sectional periphery of said vessel.

17. A device according to claim 1, wherein the implantable enclosure comprising a titanium or ceramic implantable enclosure.

18. The device according to claim 1, and further comprising an implantable bodily vessel graft.

19. The device according to claim 18, wherein said actuator is adhered to said graft to prevent uncontrolled constriction of said graft.

20. The device according to claim 19, wherein said constriction is shaped to resist further buckling under reduced pressure.

21. The device according to claim 18, wherein said actuator is positioned at the upstream end of said graft.

22. The device according to claim 18, further comprising a deformable, but substantially incompressible, medium at least partially surrounding said graft at the location of said actuator.

23. The device according to claim 18, comprising a plurality of said devices disposed along said graft.

24. The device according to claim 18, wherein one end of said graft is connected to an artery and the other end of said graft is connected to one of an artery and a vein.

25. A device according to claim 1, further comprising a measuring device coupled to the drive shaft to count a number of revolutions of the drive shaft.

26. A device according to claim 25, wherein said measuring device further is configured to transmit a signal via said antenna to the external control device indicative of a state of the drive shaft.

27. A device according to claim 1, wherein said bodily vessel is one selected from the group consisting of a blood vessel, lymph vessel, vessel in the digestive tract, vessel in the urinary tract, vessel in the reproductive tract, an AV graft, an artery, a vein, a blood circulatory system shunt, a Blalock-Taussig shunt, and an esophagus.

28. A device according to claim 1, wherein said actuator is configured to squeeze said vessel by applying force at one or more points around its periphery in a non-uniform manner.

29. A device according to claim 1, wherein said actuator is configured to maintain substantially constant the length of the perimeter of said vessel in transverse cross-section, whilst adjusting the cross-sectional area of the lumen of said vessel.

30. A device according to claim 1, wherein said actuator is configured to maintain constriction at a level such that a flow rate through the vessel is below onset of turbulence.

31. The device according to claim 1 wherein the device is configured for use in the treatment of kidney disease.

32. The device according to claim 1 wherein the device is configured for use in hemodialysis.

33. The device according to claim 1 wherein the device is configured for use in the treatment of hypoplastic heart syndrome.

34. The device according to claim 1 wherein the device is configured for use in the treatment of esophagus valve failure.

35. The device according to claim 1 wherein the device is configured for use in the treatment of obesity.

36. A method of flow control in an AV graft, comprising:

providing an implantable enclosure housing an actuator configured to engage and to adjustably constrict said AV graft, the actuator comprising 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 operatively coupled to said 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 said AV graft; and

operating the external control device to selectively constrict said AV graft at its arterial end.

37. A method according to claim 36, wherein the external control devices is operated so that said actuator applies constriction over an elongate portion of said AV graft.

38. A method according to claim 36, wherein the external control devices is operated so that said actuator constricts the AV graft at a plurality of positions along said AV graft.

39. A method according to claim 36, wherein the external control devices is operated so that said actuator constricts said AV graft so as to reduce the cross-sectional area of the lumen of said AV graft at said constriction while substantially maintaining the length of the perimeter of said AV graft.