Control system for rotational angioplasty device

• US 20030120296A1
• Filed: 10/16/2002
• Published: 06/26/2003
• Est. Priority Date: 10/19/2001
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Shturman, Leonid, Morov, Georgy Vasilevich, Malgichev, Vladimir Alekseevich
• Granted Patent: US 7,174,240 B2
• Time in Patent Office: Days
• US Class Current: 606/167
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61M 3/0202 with electronic control means or interfaces
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 3/0258 by means of electric pumps
• CPC Class Codes: Y10T 137/7793 With opening bias [e.g., pressure regulator]

Abstract

A method for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activated to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Claims

1. A method for controlling fluid flow in a rotational atherectomy device comprising the steps of:

providing a source of fluid through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating;

activating a first control to increase a rate of the fluid flow; and

activating a second control to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

2. The method of claim 1 wherein the rate of the fluid flow is independent from a rotational speed of the drive shaft.

3. The method of claim 1, further comprising the step, after the step of activating the first control, of:

deactivating the first control; and

maintaining the increased fluid flow rate for a predetermined time period after the deactivation of the first control.

4. The method of claim 1, further comprising the step, after the step of activating the second control of:

determining if a predetermined time period has elapsed after a deactivation of the first control; and

preventing the initiation of the rotation of the drive shaft after activation of the second control if the predetermined time period has elapsed.

5. The method of claim 1, further comprising the steps, after the step of activating a first control, of:

deactivating the first control;

maintaining the increased fluid flow rate for a predetermined time period after the deactivation of the first control; and

initiating the rotation of the drive shaft after the activation of the second control only if the activation of the second control occurs prior to an end of the predetermined time period.

6. The method of claim 1, further comprising the steps, after the step of activating the second control, of:

deactivating the second control to stop the rotation of the drive shaft; and

maintaining the increased flow rate for another predetermined time period after the deactivation of the second control.

7. The method of claim 1 further comprising repeating the step of activating the first control if the step of activating the second control occurs after an expiration of the predetermined time period.

8. The method of claim 1, further comprising the step after the step of activating the first control, of reactivating the first control after an expiration of a predetermined time period after the first control is deactivated, if the second control is not activated within that predetermined time period, wherein when the first control is reactivated, the fluid flow rate will change to the increased flow rate.

9. The method of claim 1, further comprising the step, after the step of activating the first control, of adjusting the fluid flow rate to the minimal flow rate at an expiration of a predetermined time period if the second control is not activated during the predetermined time period.

20. A system for controlling a flow of fluid through a rotational atherectomy device comprising:

a controller coupled to the atherectomy device, the controller comprising;

a pump control device adapted to control the flow of fluid to the atherectomy device;

a drive shaft control device adapted to control a rotation of a drive shaft in the atherectomy device;

a fluid supply unit; and

a first control device coupled to the controller and adapted to increase a flow of fluid to the atherectomy device via the pump control device; and

a second control device coupled to the controller and adapted to initiate a rotation of the drive shaft via the drive shaft control device after activation of the first control device.

The system of claim 20 wherein the flow of fluid to the atherectomy device is independent of the rotation of the drive shaft.

21. The system of claim 20 wherein the controller further comprises a fluid flow delay device adapted to maintain the flow of fluid through the rotational atherectomy device for a predetermined time period after a deactivation of the first control device.

22. The system of claim 20 wherein the controller further comprises a drive shaft disable device adapted to prevent the rotation of the drive shaft if the second control device is activated after the end of a predetermined time period after a deactivation of the first control device.

30. A controller for a rotational atherectomy system comprising:

a fluid pump control device adapted to control a pumping of a fluid to a rotational atherectomy device; and

a turbine control device adapted to control a rotation of a drive shaft in the rotational atherectomy device;

wherein the fluid pump control device comprises;

a fluid flow controller adapted to provide a pump control signal to a fluid pump;

a first control device adapted to provide a pump activation signal to the fluid flow controller; and

a second control device adapted to provide a turbine activation signal to the fluid flow controller and the turbine control device;

wherein upon activation of the first control device the fluid pump is activated to pump the fluid at a dynamic fluid flow rate and

upon activation of the second control device the fluid pump is activated to continue pumping the fluid at the dynamic fluid flow rate while the drive shaft rotates.

31. The controller of claim 30 wherein the pumping of fluid to the rotational atherectomy device is not dependent upon the rotation of the drive shaft.

32. The controller of claim 30 wherein the rotation of the drive shaft is dependent upon the pumping of fluid to the atherectomy device.

33. The controller of claim 30 wherein the fluid flow controller further includes a fluid flow delay device adapted delay the pump from changing from the dynamic fluid flow rate to a static fluid flow rate for a predetermined time period after the deactivation.

34. The controller of claim 30 wherein the fluid flow controller is further adapted to provide a turbine block signal to the turbine control device, adapted to prevent the rotation of the drive shaft if the second control device is not activated prior to an expiration of a predetermined time period after a deactivation of the first control device.

35. The controller of claim 30 wherein the fluid flow controller is further adapted to provide the control signal to the pump to continue to pump the fluid to the rotational atherectomy device at the dynamic fluid flow rate for a predetermined time period after a deactivation of the first control device.

36. The controller of claim 30 wherein the fluid flow controller is further adapted to enable an activation signal for the rotation of the drive shaft when the second control device is activated before an end of a predetermined time period after the deactivation of the first control device.

37. The controller of claim 30 wherein the first control device comprises a foot activated switch having an on position and an off position.

38. The controller of claim 30 wherein the second control device comprises a foot activated switch having an on position and an off position.

39. The controller of claim 30 wherein the fluid flow controller is further adapted to delay a change in the state of the fluid pump for a second predetermined time period following a deactivation of the second control device.

40. The controller of claim 30 wherein the fluid flow controller is adapted to maintain the state of the pump at a static flow rate during a period of time when the drive shaft is not rotating.

41. The controller of claim 30 further comprising a fluid level monitoring device adapted to detect a level of a fluid supply for the rotational atherectomy system and activate an alarm device if the fluid level falls below a predetermined level.

42. The controller of claim 30 further comprising a pump status device adapted to detect an open position of a pump in the rotational atherectomy system and activate an alarm device if the pump is in the open position.

43. The controller of claim 30 further comprising an alarm device adapted to provide an alarm indication if a fluid supply level to the system is below a predetermined level.

44. The controller of claim 30 further comprising an alarm device including an alarm indicator.

45. The controller of claim 44 wherein the alarm indicator is an audible alarm that can be muted by activating an alarm mute switch in the controller.

46. The controller of claim 43 wherein the alarm device is adapted to prevent the rotation of the drive shaft if the alarm device is activated prior to activation of the second control device.

47. The controller of claim 43 wherein the alarm device is adapted to stop the rotation of the drive shaft if the alarm device is activated.

48. The controller of claim 30 wherein the control signal is adapted to cause the pump to pump at a dynamic flow rate or a static flow rate.

50. A fluid control system for a rotational atherectomy device comprising:

a fluid pump connected to the atherectomy device;

a fluid supply connected to the fluid pump;

a first control switch adapted to initiate [maintain] a dynamic flow of fluid to the atherectomy device; and

a second control switch adapted to initiate [change the flow of fluid from static to dynamic] a second flow of fluid to the atherectomy device and [initiate] a rotation of a drive shaft in the atherectomy device.

51. The fluid control system of claim 50 further comprising a control device adapted to receive inputs from the first control switch and the second control switch and regulate a pumping of the fluid by the fluid pump.

52. The fluid control system of claim 50 wherein the control device is adapted to maintain the dynamic flow of fluid for a predetermined time period after a deactivation of the first control switch.

53. The fluid control system of claim 50 wherein the control device is further adapted to initiate [maintain] the second flow of fluid and the rotation of the drive shaft if the second control device is activated within a predetermined time period after a deactivation of the first control device.

54. The fluid control system of claim 50 wherein the control device is adapted to prevent the rotation of the drive shaft if the second control device is activated after an end of a predetermined time period following a deactivation of the first control device.

55. The fluid control system of claim 50 wherein the first control switch comprises a foot activated switch device.

56. The fluid control system of claim 50 wherein the second control switch comprises a foot activated switch device.

57. A rotational atherectomy system comprising:

a rotational atherectomy device;

a fluid source adapted to supply fluid to the device;

a fluid pump system adapted to pump fluid from the fluid source to the device;

a switching mechanism having at least a first mode and a second mode, the first mode adapted to change a state of the fluid pump from a static state to a dynamic state, and the second mode adapted to activate a rotation of a drive shaft in the device.

71. The system of claim 70 wherein the switching mechanism comprises a first switch and a second switch, wherein an activation of the first switch corresponds to the first mode and an activation of the second switch corresponds to the second mode.

72. The system of claim 70 wherein the change of the state of the fluid pump from the static state to the dynamic state increases a flow of fluid from the fluid source to the device.

73. The system of claim 70 wherein the static state of the pump corresponds to at least one state of the rotational atherectomy device when the drive shaft is not rotating.

74. The system of claim 70 wherein the dynamic state of the pump in the first mode corresponds to a state of the rotational atherectomy device for a time period prior to the rotation of the drive shaft.

75. The system of claim 70 wherein the dynamic state of the pump in the second mode corresponds to a state of the rotational atherectomy device just prior to the rotation of the drive shaft and during the rotation of the drive shaft.

76. The system of claim 70 wherein the state of the pump remains in the dynamic state for a predetermined period of time after the first mode is activated, and wherein the switching mechanism cannot enter the second mode after the end of the predetermined time period.

77. The system of claim 70 wherein the state of the pump changes from the dynamic state to the static state at the expiration of a predetermined time after the first mode is activated if the second mode is not activated within the predetermined time period.

78. The system of claim 70 wherein the second mode is entered only if the switching mechanism is activated during a predetermined time period following entry of the first mode.

79. The system of claim 70 wherein the second mode maintains the state of the pump in the dynamic state.

80. The system of claim 70 wherein at the end of the second mode, the state of the pump remains in the dynamic state for a second predetermined time period and returns to the static state at the end of the second predetermined time period.

81. The system of claim 70 wherein at the end of the second mode, the state of the pump remains in the dynamic state for a second predetermined time period before returning to the static state unless the first mode or the second mode is reactivated.

82. The system of claim 70 wherein the activation of the second mode only occurs after the activation of the first mode.

a first control device and a second control device;

and

83. A rotational atherectomy system comprising:

a rotational atherectomy device;

a fluid source adapted to supply fluid to the device;

a pump system adapted to pump fluid from the fluid source to the device;

a first switch adapted to increase a flow of fluid from the fluid source to the device from a first flow rate to a second flow rate when the switch is activated; and

a second switch adapted to activate a rotation of a drive shaft in the device when the second switch is activated.

84. The system of claim 90 wherein a pumping of fluid to the device is independent of the rotation of the drive shaft.

85. A method for controlling a flow of fluid in a rotational atherectomy device comprising the steps of:

providing a source of fluid through a pump to the rotational atherectomy device, wherein a minimal flow of fluid is maintained through the system when the system is in an idle mode;

activating a first control to initiate a first flow of fluid to the device; and

activating a second control, wherein activation of the second control includes the steps of;

initiating a second flow of fluid to the device; and

initiating a rotation of a drive shaft of the device, wherein the second flow of fluid to the device is independent of the rotation of the drive shaft.

86. A method of removing tissue comprising the steps of:

providing a tissue removal device comprising a rotational atherectomy device that includes a fluid pump that is adapted to pump fluid at flow rate independent of a rotational speed of a drive shaft of the atherectomy device;

providing a preflush of fluid at an increased rate to a lesion site for predetermined time period prior to the rotation of a drive shaft;

activating the rotation of the drive shaft prior to the end of the predetermined time period, wherein the fluid flow rate is maintained at the increased rate during rotation of the drive shaft and the tissue is removed by the rotational atherectomy device; and

deactivating the rotation of the drive shaft, wherein the fluid flow rate remains at the increased level for another predetermined time period following the deactivation of the rotation of the drive shaft.

87. A method for controlling fluid flow rate around a drive shaft of a rotational angioplasty device comprising the steps of:

providing a fluid pump to pump a fluid around the drive shaft of the device and providing at least two of the controls one of which is used to control the fluid pump and the other to control both the fluid pump and a rotation of the drive shaft of the device;

activating a first control to increase fluid flow rate around the drive shaft without initiating rotation of the drive shaft; and

activating a second control to initiate rotation of the drive shaft and to continue to pump fluid around the drive shaft of the device at an increased fluid flow rate.