METHODS AND SYSTEMS FOR ESTABLISHING RETROGRADE CAROTID ARTERIAL BLOOD FLOW

• US 20110166497A1
• Filed: 03/17/2011
• Published: 07/07/2011
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: CRIADO, ENRIQUE, Garrison, Michi E., Hyde, Gregory M., Schaer, Alan, Renati, Richard, Chou, Tony M.
• Granted Patent: US 9,011,364 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• 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 5/007 : for contrast media
• CPC Class Codes: G11B 25/043 : using rotating discs
• CPC Class Codes: G11B 5/4846 : Constructional details of the electrical connection between arm and support

Abstract

Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Claims

1. A system for use in accessing and treating a carotid artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the common carotid artery;

a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site; and

a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt.

2. A system as in claim 1, wherein the first and second blood flow state are selected from the group comprising a passive flow state, an active flow state, an aspiration state, and an off state.

3. A system as in claim 2, wherein the first state is a passive flow state and the second state is an active flow state.

4. A system as in claim 2, wherein the active state corresponds to the system using a pump or syringe to drive retrograde blood flow through the shunt, the passive flow state corresponds to the system relying on arterial perfusion stump pressure to drive retrograde blood flow through the shunt, the aspiration state corresponds to the system using a suction source to drive retrograde blood flow through the shunt, and the off state corresponds to zero blood flow through the shunt.

5. A system as in claim 2, wherein the passive flow state includes a state of low flow rate and a state of high flow rate

6. A system as in claim 1, wherein the first blood flow state is a low flow rate and the second blood flow state is a high flow rate.

7. A system as in claim 6, wherein the high flow rate is at least two fold higher than the low flow rate.

8. A system as in claim 6, wherein the high rate is at least three fold higher than the low rate.

9. A system as in claim 6, wherein the high rate is at least five fold higher than the low rate.

10. A system as in claim 6, wherein at least one of the low flow rate and the high flow rate is predetermined without requiring input from a user.

11. A system as in claim 6, wherein the system accepts input from a user regarding a value of at least one of the low flow rate and high flow rate.

12. A system as in claim 6, further comprising an anatomical data sensor that senses neurological data, and wherein the flow control assembly sets at least one of the low flow rate and high flow rate based on the neurological data.

13. A system as in claim 1, wherein the flow control assembly regulates blood flow between a first blood flow rate, a second blood flow rate, and a third blood flow rate.

14. A system as in claim 1, wherein the flow control assembly includes a flow resistance element adapted to adjust a resistance of blood flow through the shunt.

15. A system as in claim 14, wherein the flow resistance element adjusts the resistance by varying a cross-sectional area of an elongate flow lumen through the shunt.

16. A system as in claim 14, wherein the flow resistance element comprises an external compression mechanism for selectively collapsing and expanding an internal flow lumen of the shunt.

17. A system as in claim 16, wherein the external compression mechanism comprises opposed plates which press against the shunt to compress the shunt between the plates.

18. A system as in claim 14, wherein the flow resistance element comprises a mechanism that axially elongates a portion of the shunt to increase the length of and decrease the cross-sectional area of an internal lumen within the portion of the shunt.

19. A system as in claim 14, wherein the flow resistance element comprises a coiled region of the shunt, wherein an external clamp or an internal dowel is adapted to compress or stretch the coiled region of the shunt.

20. A system as in claim 14, wherein the flow resistance element comprises two or more parallel flow paths of the shunt and a valve to open or close one or more of the flow paths to selectively direct blood flow through one or more of the flow paths.

21. A system as in claim 1, wherein the flow control assembly includes a controller that controls the one or more components of the flow control assembly.

22. A system as in claim 21, wherein the controller is an automatic controller that automatically controls the one or more components without requiring interaction from a user.

23. A system as in claim 22, wherein the automatic controller is adapted to cede control of at least one of the one or more components of the flow control assembly to a user.

24. A system as in claim 21, wherein the controller includes at least one actuator that can be operated by a user to cause a change in the blood flow state.

25. A system as in claim 24, wherein the controller includes multiple actuators.

26. A system as in claim 25, wherein the multiple actuators include an actuator that can be operated by a user to change the blood flow state from a first blood rate to a second rate.

27. A system as in claim 25, wherein the multiple actuators include an actuator to cause the blood flow state to move toward a zero blood flow rate.

28. A system as in claim 24, wherein the actuator comprises a stopcock coupled to the shunt and wherein the stopcock can be actuated to shut off flow through the shunt line or to open the shunt to an aspiration source.

29. A system as in claim 24, further comprising a single housing that contains the controller and the at least one actuator.

30. A system as in claim 29, wherein the housing contains an indicator that indicates the blood flow state.

31. A system as in claim 29, wherein the housing contains a display that displays a value of the blood flow rate through the shunt.

32. A system as in claim 29, wherein the flow control assembly includes an indicator that indicates the blood flow state and wherein the indicator is separate from the housing.

33. A system as in claim 21, wherein the controller is a remote controller that is communicatively coupled to at least a portion of the system via a wired connection or a wireless connection.

34. A system as in claim 1, wherein the flow control assembly automatically regulates the flow rate to a baseline rate after a predetermined time period of a higher flow rate.

35. A system as in claim 34, wherein the predetermined time period is within the range of 15 to 60 seconds.

36. A system as in claim 6, wherein the low flow rate is a baseline flow rate.

37. A system as in claim 6, wherein the baseline rate is based on patient tolerance of a given blood flow rate and wherein patient tolerance is based on at least one of (1) an automatic measurement from an anatomical data sensor and (2) user observation of patient symptoms.

38. A system as in claim 36, wherein the flow control assembly is biased toward the baseline flow rate.

39. A system as in claim 1, wherein the flow control assembly includes an indicator that indicates the flow state.

40. A system as in claim 39, wherein the indicator is at least one of an audio and a visual indicator.

41. A system as in claim 6, wherein the flow control assembly outputs a signal when the flow rate changes between the high flow rate and the low flow rate.

42. A system as in claim 1, wherein the flow control assembly outputs a signal when there is no blood flow through the shunt.

43. A system as in claim 1, wherein the flow control assembly includes a display to indicate a level of blood flow through the shunt.

44. A system as in claim 43, wherein the display is digital.

45. A system as in claim 43, wherein the display is analog.

46. A system as in claim 1, wherein the one or more components of the flow control assembly includes a pump adapted to drive blood flow through the shunt.

47. A system as in claim 46, wherein the pump is manually controlled by a user.

48. A system as in claim 46, further comprising a controller that automatically controls the pump.

49. A system as in claim 1, wherein the one or more components of the flow control assembly includes a syringe or other aspiration source that can be controlled to actively increase blood flow through the shunt.

50. A system as in claim 1, wherein the one or more components of the flow control assembly includes a flow sensor that senses an aspect of the blood flow through the shunt.

51. A system as in claim 50, wherein the flow sensor senses volumetric blood flow through the shunt.

52. A system as in claim 50, wherein the flow sensor is an electrical or mechanical sensor.

53. A system as in claim 50, wherein the flow sensor provides feedback data to a controller and wherein the controller automatically causes the flow control assembly to adjust the flow rate through the shunt based on the feedback data.

54. A system as in claim 1, wherein the one or more components of the flow control assembly includes an anatomical data sensor that interacts with neurological anatomy.

55. A system as in claim 54, wherein the anatomical data sensor is a transcranial Doppler ultrasonography that outputs a signal indicative of the state of blood flow through the brain.

56. A system as in claim 54, wherein the anatomical data sensor provides feedback data to a controller and wherein the controller automatically causes the flow control assembly to adjust the flow rate through the shunt based on the feedback data.

57. A system as in claim 1, further comprising a venous return device adapted to output blood flow wherein the venous return device is adapted to be inserted into a vein, and wherein the shunt fluidly connects the arterial access device to the venous return device such that the blood flows through the shunt from the common carotid artery to the vein.

58. A system as in claim 1, wherein the shunt is adapted to be connected to an external receptacle such that the blood flows from the common carotid artery through the shunt to the external receptacle.

59. A system as in claim 58, wherein the blood flow into the receptacle is regulated by setting a height of the reservoir to increase or decrease a pressure gradient between the common carotid artery and the receptacle.

60. A system as in claim 1, wherein the arterial access device comprises a distal sheath portion which enters the common carotid artery, and a flow line which connects to the shunt.

61. A system as in claim 60, wherein the arterial access device further comprises a proximal extension which provides catheter access.

62. A system as in claim 1, wherein the arterial access device comprises a distal sheath portion which enters the common carotid artery, wherein the distal sheath portion has a distal region with a reduced diameter to facilitate introduction into the common carotid artery and a proximal region having a larger luminal diameter to decrease overall flow resistance.

63. A system as in claim 62, wherein the distal region is in the range of about 2-4 cm in length.

64. A system as in claim 62, wherein the distal region has an inner diameter in the range of 2.16 mm to 2.92 min and the proximal region has an inner diameter to the range from 2.79 mm to 3.43 mm.

65. A system as in claim 57, wherein the venous return device comprises a distal sheath portion which enters the internal jugular vein or femoral vein.

66. A system as in claim 1, wherein the shunt is removably attached to the arterial access device.

67. A system as in claim 1, wherein the flow control assembly includes at least one valve coupled to the shunt.

68. A system as in claim 67, wherein the at least one valve is a check valve or a high pressure valve.

69. A system as in claim 1, further comprising an extension adapted to adjust the length of the shunt.

70. A system as in claim 1, wherein the arterial access device comprises a distal sheath portion which enters the common carotid artery and an expandable occlusion member adapted to occlude the common carotid artery.

71. A system as in claim 14, wherein the flow resistance element comprises a dowel that removably inserts into the pathway for blood to flow from the arterial access device to the return site, wherein the dowel increases resistance to flow through the pathway when the dowel is inserted in the pathway.

72. A system for use in accessing and treating a carotid artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery and receive blood flow from the common carotid artery;

a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site;

a flow mechanism coupled to the shunt and adapted to vary the blood flow through the shunt between a first blood flow rate and a second blood flow rate;

a controller that automatically interacts with the flow mechanism to regulate blood flow through the shunt between the first blood flow rate and the second blood flow rate without requiring input from a user.

73. A system as in claim 72, wherein the flow mechanism is adapted to vary the blood flow through the shunt between a first blood flow rate, a second blood flow rate, and a third blood flow rate.

74. A system as in claim 72 further comprising a flow sensor that senses an aspect of blood flow through the shunt wherein the sensor feeds data to the controller.

75. A system as in claim 72, wherein the flow mechanism is a pump or a syringe.

76. A system as in claim 72, wherein the flow mechanism is adapted to vary resistance of blood flow through the shunt.

77. A system as in claim 72, wherein a user can manually override the controller'"'"'s automatic regulation of the blood flow through the shunt.

78. A system as in claim 72, wherein the controller includes a timer that measures a period of time that blood flow through the shunt is at the second rate and wherein the controller automatically reverts the blood flow to the first rate after a predetermined period of time of the second rate.

79. A system as in claim 72, further comprising wherein the controller is adapted to automatically increase the rate of blood flow through the shunt when there is an increased risk of emboli release.