Blood circulation assistance device

• US 6,984,201 B2
• Filed: 03/24/2003
• Issued: 01/10/2006
• Est. Priority Date: 09/23/2000
• Status: Expired due to Fees

• Current Assignee: Cardiak Ltd.
• Original Assignee: Cardiak Ltd.
• Inventors: Khaghani, Asghar, Andrews, Geoffrey Thomas, Smith, Nigel Gordon, Bowles, Christopher
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/395,706
• Publication Number:
  US 20030233023A1
• Time in Patent Office: 1,023 Days
• Field of Search: 600 16- 18
• US Class Current: 600/17
• CPC Class Codes: A61M 2205/0283 Electro-active polymers [EAP]
• CPC Class Codes: A61M 60/152 branching on and drawing blood from a blood vessel
• CPC Class Codes: A61M 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/432 with diastole or systole switching by stopping or reversing the blood pump operating at a much higher cyclical speed than the heart beat
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/486 generated by electro-active actuators, e.g. using electro-active polymers or piezoelectric elements
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/839 of devices for mechanical circulatory actuation

Abstract

A blood circulation assistance device (1), for location around a blood conduit (20). The device comprises: an inflatable bladder (10) moveable between a contracted form and an expanded form, for compressing the blood conduit (20) to provide counterpulsation. Pump means (30) in fluid communication with the bladder (10) move the bladder (10) from the contracted form to the expanded form. The pump means (30) comprises a centrifugal impeller (62) rotatable about an axis (61) to effect pumping. The impeller (62) is moveable axially between first and second positions to effect a reversal of the direction of pumping. Control means (50), in communication with the pump means, is capable of monitoring the cardiac cycle of an individual and triggering the pump means (30) to move the bladder (10) to the expanded form at diastole. An outer cuff, surrounds at least a portion of the bladder (10), providing an outer limiting extent to the movement of the bladder (10).

Claims

1. A blood circulation assistance device, for location around a blood conduit, the device comprising:

at least one inflatable bladder moveable between a contracted form and an expanded form, for compressing the blood conduit to provide counterpulsation;

pump means in fluid communication with the at least one inflatable bladder for moving the at least one inflatable bladder from the contracted form to the expanded form, the pump means comprising a centrifugal impeller rotatable about an axis to effect pumping, the impeller being moveable axially between first and second positions to effect a reversal of the direction of pumping;

control means in communication with the pump means, the control means being capable of monitoring the cardiac cycle of an individual and triggering the pump means to move the at least one inflatable bladder to the expanded form at diastole; and

an outer cuff, surrounding at least a portion of the at least one inflatable bladder, providing an outer limiting extent to the movement of the at least one inflatable bladder,

the at least one inflatable bladder being locatable between the blood conduit and the outer cuff such that, in its expanded form, the at least one inflatable bladder presses against the outer limiting extent of the outer cuff to compress the blood conduit.

2. A blood circulation assistance device according to claim 1 wherein the pump means is connected in fluid communication with the at least one inflatable bladder by a substantially rigid tube.

3. A blood circulation assistance device according to claim 2 wherein the substantially rigid tube is less than 20 mm long.

4. A blood circulation assistance device according to claim 1 wherein the pump means is located adjacent the at least one inflatable bladder such that the pump is directly connected to the at least one inflatable bladder.

5. A blood circulation assistance device according to claim 1 further comprising a fluid to effect fluid communication between the pump means and at least one inflatable bladder wherein the fluid is a liquid.

6. The blood circulation assistance device according to claim 5, wherein the liquid comprises a viscosity of up to 10³ Pas.

7. The device of claim 6 wherein the liquid has a viscosity in the range of 1 Pa to 10³ Pas.

8. A blood circulation assistance device according to claim 1 wherein the pump means further comprise first and second diffusers for receiving fluid from the impeller, the centrifugal impeller being axially moveable relative to the diffusers between the first position in which the impeller is in fluid communication with the first diffuser and the second position in which the impeller is in fluid communication with the second diffuser to effect a reversal of the direction of pumping.

9. A blood circulation assistance device according to claim 8 wherein the pump means further comprise first and second intakes for supplying fluid to the impeller, the intakes being located such that, in the first position, the centrifugal impeller is in fluid communication with the first intake and in the second position, the impeller is in fluid communication with the second intake.

10. A blood circulation assistance device according to claim 1 wherein the pump means further comprise an electromagnet for sliding the impeller between the first and second positions.

11. A blood circulation assistance device according to claim 1 wherein there is a plurality of inflatable bladders.

12. A blood circulation assistance device according to claim 11 wherein the inflatable bladders are configured to be locatable symmetrically about the axis of the blood conduit.

13. A blood circulation assistance device according to claim 1 wherein the at least one inflatable bladder is made from a material having a tensile strength in a range from 15 to 35 MPas.

14. The blood circulation assistance device of claim 13 wherein the at least one inflatable bladder is made from a material having a tensile strength in a range from 20 to 30 MPas.

15. The blood circulation assistance device of claim 13 wherein the at least one inflatable bladder is made from a material having a tensile strength of about 25 MPas.

16. A blood circulation assistance device according to claim 1 wherein the at least one inflatable bladder is made from a material having a Modulus at 100% elongation in a range from 2 to 6 MPas.

17. The blood circulation assistance device of claim 16 wherein the bladder is made from a material having a Modulus at 100% elongation in a range from 2.5 to 5 MPas.

18. The blood circulation assistance device of claim 16 wherein the bladder is made from a material having a Modulus at 100% elongation of about 2.64 MPas.

19. A blood circulation assistance device according to claim 1 wherein the at least one inflatable bladder is made from a material having a modulus at 300% elongation in a range from 4 to 10 MPas.

20. A blood circulation assistance device according to claim 19 wherein the bladder is made from a material having a Modulus at 300% elongation in a range from 6 to 7 MPas.

21. A blood circulation assistance device according to claim 19 wherein the bladder is made from a material having a Modulus at 300% elongation of about 6.23 MPas.

22. A blood circulation assistance device according to claim 1 further comprising at least one plate connected to the at least one inflatable bladder, the at least one plate being locatable adjacent the blood conduit such that when the at least one inflatable bladder is in its expanded form the at least one plate compresses the blood conduit.

23. A blood circulation assistance device according to claim 22 wherein the device comprises two opposing plates, locatable on either side of the blood conduit.

24. A blood circulation assistance device according to claim 1 wherein the outer cuff is a substantially rigid shell.

25. A blood circulation assistance device according to claim 24 wherein the cross section of the outer cuff has an incomplete perimeter bounded by two opposing outer edges along the length of the cuff such that the device is locatable to surround a portion of the circumference of the blood conduit.

26. A blood circulation assistance device according to claim 25 further comprising a substantially rigid panel attachable to the opposing outer edges of the outer cuff such that the rigid panel co-operates with the outer cuff to define the outer limiting extent to the movement of the at least one inflatable bladder.

27. A blood circulation assistance device according to claim 25 wherein the opposing outer edges of the outer cuff are attachable to a bone such that the bone co-operates with the outer cuff to define the outer limiting extent to the movement of the at least one inflatable bladder.

28. A blood circulation assistance device according to claim 1 wherein the outer cuff has a substantially circular cross-section and is locatable to surround the whole circumference of the blood conduit.

29. A blood circulation assistance device according to claim 28 wherein the outer extent of the outer cuff defines a plane, the outer cuff comprising two portions connected by a hinge perpendicular to the plane such that the outer cuff is moveable from an open configuration for positioning of the device about a blood conduit to a closed configuration for the device to effect counterpulsation of the blood conduit.

30. A blood circulation assistance device according to claim 29 wherein the outer cuff further comprises a clip for locking the two portions of the outer cuff in the closed configuration.

31. A blood circulation assistance device according to claim 1 further comprising a cushion locatable between the blood conduit and the at least one inflatable bladder for cushioning the blood conduit when the at least one inflatable bladder moves to the expanded form.

32. A blood circulation assistance device according to claim 31 wherein the cushion comprises a Teflon™

pad.

33. A blood circulation assistance device according to claim 1 wherein the pump means is operable to move the at least one inflatable bladder from the contracted form to the expanded form in 10 to 200 ms, to remain in the expanded form for between 1 and 300 ms and to return to the contracted form in 10 to 400 ms in order to effect counterpulsation.

34. A blood circulation assistance device according to claim 1 wherein the device is capable of displacing up to 80 ml of blood from the blood conduit when the at least one inflatable bladder moves from the contracted form to the expanded form about a blood conduit.

35. A blood circulation assistance device according to claim 34 wherein the device is configured to displace blood in a range of 15 ml to 40 ml.

36. A blood circulation assistance device according to claim 1 wherein the blood conduit is an artificial blood conduit.

37. A blood circulation assistance device according to claim 36 wherein the artificial blood conduit is a vascular shunt.

38. A blood circulation assistance device according to claim 37 wherein the diameter of the vascular shunt tapers from one end of the shunt to the other end.

39. A blood circulation assistance device according to claim 36 wherein the artificial blood conduit is integral to the blood circulation assistance device.

40. A blood circulation assistance device according to claim 1 wherein the control means comprise a pacemaker.

41. A blood circulation assistance device according to claim 1 wherein the pump means is powered electrically, the control means comprising means for monitoring the current to the pump means.

54. A method according to claim 42 using the blood circulation assistance device of claim 29 further comprising the steps of grafting either end of the vascular shunt to a blood vessel in the individual such that blood passes through the vascular shunt in parallel with the blood vessel.

42. A method of providing counterpulsation to the blood circulation of an individual comprising the steps of:

providing a blood circulation assistance device comprising;

at least one inflatable bladder, moveable between an expanded and a contracted form;

pump means, in fluid communication with the at least one inflatable bladder, for moving the at least one inflatable bladder from the contracted form to the expanded form;

the pump means comprising a centrifugal impeller rotatable about an axis to effect pumping, the impeller being moveable axially between first and second positions to effect a reversal of the direction of pumping; and

an outer cuff, surrounding at least a portion of the at least one inflatable bladder, and providing an outer limiting extent to the movement of the at least one inflatable bladder;

locating the outer cuff about a blood conduit in the individual, the at least one inflatable bladder being between the blood conduit and the outer cuff;

monitoring the cardiac cycle of the individual; and

effecting counterpulsation on the blood conduit by operating the pump means to move the at least one inflatable bladder from the contracted form to the expanded form at diastole, the at least one inflatable bladder thus pressing against the outer limiting extent of the outer cuff and compressing the blood conduit.

43. A method according to claim 42 wherein the blood circulation assistance device further comprises control means in communication with the pump means, the control means being capable of monitoring the cardiac cycle of an individual and triggering the pump means to move the at least one inflatable bladder to the expanded form at diastole, and wherein the at least one inflatable bladder is locatable between the blood conduit and the outer cuff such that, in its expanded form, the at least one inflatable bladder presses against the outer limiting extent of the outer cuff to compress the blood conduit.

44. A method according to claim 42 wherein the outer cuff has a substantially circular cross-section and is locatable to surround the whole circumference of the blood conduit, and wherein the outer extent of the outer cuff defines a plane, the outer cuff comprising two portions connected by a hinge perpendicular to the plane such that the outer cuff is movable from an open configuration for positioning of the device about a blood conduit to a closed configuration for the device to effect counter pulsation of the blood conduit, and wherein the step of locating the outer cuff about the blood conduit comprises:

moving the outer cuff into the open configuration;

positioning the outer cuff about the blood conduit; and

moving the outer cuff into the closed configuration.

45. A method according to claim 44 wherein the outer cuff further comprises a clip for locking the two portions of the outer cuff in the closed configuration, and wherein the step of locating the outer cuff about the blood conduit further comprises the step of, after moving the outer cuff into the closed configuration:

locking the two portions of the outer cuff with the clip.

46. A method according to claim 42 wherein the outer cuff is in a substantially rigid shell, the cross section of the outer cuff has an incomplete perimeter bounded by two opposing outer edges along the length of the cuff such that the device is locatable to surround a portion of the circumference of the blood conduit, wherein the blood circulation assistance device further comprises a substantially rigid panel attachable to the opposing outer edges of the outer cuff such that the rigid panel cooperates with the outer cuff to define the outer limiting extent to the movement of the at least one inflatable bladder, and wherein the step of locating the outer cuff about the blood conduit comprises:

inserting the blood conduit through the opposing outer edges of the outer cuff; and

attaching the substantially rigid panel to the opposing outer edges of the outer cuff so that the whole circumference of the blood conduit is surrounded by the outer limiting extent defined by the outer cuff and the substantially rigid panel.

47. A method according to claim 42 wherein the outer cuff is a substantially rigid shell, the cross section of the outer cuff has an incomplete perimeter bounded by two opposing outer edges along the length of the cuff such that the device is locatable to surround a portion of the circumference of the blood conduit, the opposing outer edges of the outer cuff are attachable to a bone such that the bone cooperates with the outer cuff to define the outer limiting extent to the movement of the at least one inflatable bladder, and wherein the step of locating the outer cuff about the blood conduit comprises:

inserting the blood conduit through the opposing outer edges of the outer cuff; and

attaching the opposing outer edges of the outer cuff to a bone in the individual so that the whole circumference of the blood conduit is surrounded by the outer limiting extent defined by the outer cuff and the bone.

48. A method according to claim 47 wherein the bone is a vertebra.

49. A method according to claim 42 wherein the blood conduit is an artificial conduit, and further comprising the steps of severing a blood vessel in the individual to provide two ends of the blood vessel and attaching either end of the artificial blood conduit to a respective end of the blood vessel.

50. A method according to claim 49 further comprising the step of removing a section of the blood vessel prior to attaching either end of the artificial blood conduit to the respective ends of the blood vessel.

51. A method according to claim 49 wherein the blood vessel is the aorta of the individual.

52. A method according to claim 51 wherein the blood vessel is the ascending aorta.

53. A method according to claim 51 wherein the blood vessel is the descending aorta.

55. A method according to claim 42 wherein the blood conduit is a blood vessel in the individual.

56. A method according to claim 55 further comprising the step of inserting a synthetic patch into the wall of the blood vessel to increase the diameter of the blood vessel.

57. A method according to claim 42 wherein no copulsation is performed.

58. A blood circulation assistance device, for location around a blood conduit, the device comprising:

solid state compression means moveable between a contracted form and an expanded form, for compressing the blood conduit to provide counterpulsation,

control means in communication with the solid state compression means, the

control means being capable of monitoring the cardiac cycle of an individual and triggering the solid state compression means to move to the expanded form at diastole; and

an outer cuff surrounding at least a portion of the solid state compression

means, providing an outer limiting extent to the movement of the solid state compression means, the solid state compression means being locatable between the blood conduit and the outer cuff such that, in its expanded form, the solid state compression means presses against the outer limiting extent of the outer cuff to compress the blood conduit.

59. A blood circulation assistance device according to claim 58 wherein the solid state compression means comprises at least one piezoelectric and/or electrostrictive compression elements.

60. A blood circulation assistance device according to claim 58 wherein the solid state compression means comprises an array of compression elements moveable from the contracted to the expanded form.

61. A blood circulation assistance device according to claim 60 wherein the compression elements in the array are moveable to the expanded form sequentially so as to effect peristaltic compression of the blood conduit.