Method and apparatus for treating a carotid artery

• US 8,870,805 B2
• Filed: 12/13/2010
• Issued: 10/28/2014
• Est. Priority Date: 11/21/2003
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Chang, David W.
• Primary Examiner(s): HAND, MELANIE JO
• Application Number:
  US12/966,974
• Publication Number:
  US 20110082408A1
• Time in Patent Office: 1,415 Days
• Field of Search: 604/8, 604/9, 606/200, 623/1, 623/11, 623/1.12, 623/1.15, 623/1.16
• US Class Current: 604/8
• CPC Class Codes: A61B 17/12036 partial occlusion
• 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 17/12136 Balloons
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22065 Functions of balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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: 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 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/67 : Containers incorporating a piston-type member to create suction, e.g. syringes cupping glasses A61M1/08; with a flexible member creating suction A61M1/68
• CPC Class Codes: A61M 2025/0177 : having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/7545 : for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61M 27/002 : Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

One disclosed embodiment comprises a method for treating lesions in the carotid artery of a mammalian body. The method comprises transcervical access and blocking of blood flow through the common carotid artery (with or without blocking of blood flow through the external carotid artery), shunting blood from the internal carotid artery and treating the lesion in the carotid artery.

Claims

1. A method of treating a carotid artery, comprising:

forming a puncture opening through a wall of the common carotid artery;

positioning through the puncture an arterial access sheath and dilator system, wherein the arterial access sheath and dilator system comprises an arterial access sheath and a dilator inside the arterial access sheath, wherein the arterial access sheath comprises a first occlusion element adapted to occlude the common carotid artery and wherein the dilator comprises a tapered distal end;

removing the dilator from the arterial access sheath; and

expanding the first occlusion element to occlude the common carotid artery.

2. A method as in claim 1, wherein forming the puncture opening comprises making the puncture opening directly into the common carotid artery accessed through a transcervical surgical incision.

3. A method as in claim 1, wherein forming the puncture opening comprises performing a percutaneous puncture into the common carotid artery.

4. A method as in claim 1, further comprising:

reversing the direction of natural blood flow in the common carotid artery; and

shunting blood from the common carotid artery to a venous system of the patient via the arterial access sheath.

5. A method as in claim 1, further comprising:

introducing a therapeutic catheter through the arterial access sheath; and

treating the carotid artery.

6. A method as in claim 5, wherein the therapeutic catheter is a stent delivery catheter and treating the carotid artery comprises deploying a stent using the stent delivery catheter.

7. A method as in claim 1, wherein the arterial access sheath comprises a second occlusion element distal of the first occlusion element, and further comprising:

positioning the second occlusion element in an external carotid artery branching from the common carotid artery; and

expanding the second occlusion element to occlude the external carotid artery.

8. A method as in claim 7, further comprising:

introducing a therapeutic catheter into the carotid artery through an exit port located on the side of the arterial access sheath between the first and second occlusion elements; and

treating the carotid artery.

9. A method as in claim 1, wherein the first occlusion element is an inflatable balloon.

10. A method as in claim 1, wherein the dilator comprises an internal lumen configured to receive a guidewire.

11. A method as in claim 1, wherein forming the puncture comprises forming the puncture with a needle, and wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting a guidewire through the needle, removing the needle, and advancing the arterial access sheath system over the guidewire.

12. A method as in claim 1, wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting the arterial access sheath and dilator system through the puncture without previously inserting an introducer device through the puncture.

13. A method as in claim 1, wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting the arterial access sheath through the puncture without riding the sheath over a guidewire.

24. A method as in claim 10, wherein forming the puncture opening comprises making the puncture opening directly into the common carotid artery accessed through a transcervical surgical incision.

25. A method as in claim 10, wherein forming the puncture opening comprises performing a percutaneous puncture into the common carotid artery.

26. A method as in claim 10, further comprising:

reversing the direction of natural blood flow in the common carotid artery; and

shunting blood from the common carotid artery to a venous system of the patient via the arterial access sheath.

27. A method as in claim 10, further comprising:

introducing a therapeutic catheter through the arterial access sheath; and

treating the carotid artery.

28. A method as in claim 27, wherein the therapeutic catheter is a stent delivery catheter and treating the carotid artery comprises deploying a stent using the stent delivery catheter.

29. A method as in claim 10, wherein the arterial access sheath comprises a second occlusion element distal of the first occlusion element, and further comprising:

positioning the second occlusion element in an external carotid artery branching from the common carotid artery; and

expanding the second occlusion element to occlude the external carotid artery.

30. A method as in claim 29, further comprising:

introducing a therapeutic catheter into the carotid artery through an exit port located on the side of the arterial access sheath between the first and second occlusion elements; and

treating the carotid artery.

31. A method as in claim 10, wherein the first occlusion element is an inflatable balloon.

32. A method as in claim 10, wherein forming the puncture comprises forming the puncture with a needle, and wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting the guidewire through the needle, removing the needle, and advancing the arterial access sheath system over the guidewire.

33. A method as in claim 10, wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting the arterial access sheath and dilator system through the puncture without previously inserting an introducer device through the puncture.

34. A method as in claim 10, wherein positioning through the puncture an arterial access sheath and dilator system comprises inserting the arterial access sheath through the puncture without riding the sheath over a guidewire.

14. A system for use in accessing and treating a carotid artery, the system comprising:

an arterial access sheath comprising a lumen extending between a proximal end and a distal end adapted to receive blood flow from a common carotid artery, and a dilator positionable within the lumen of the arterial access sheath, the arterial access sheath and dilator adapted to be collectively introduced through a puncture in the common carotid artery;

a first occlusion element coupled to the arterial access sheath at a distal region of the arterial access sheath and adapted to expand and occlude the common carotid artery; and

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

15. A system as in claim 14, further comprising a second occlusion element coupled to the arterial access sheath at a position distal of the first occlusion element, wherein the second occlusion element is configured to expand and occlude the external carotid artery while the first occlusion element occludes the common carotid artery.

16. A system as in claim 14, further comprising a flow control assembly directly 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.

17. A system as in claim 14, wherein the first occlusion element is an inflatable balloon.

18. A system as in claim 15, further comprising a side opening located on the side of the sheath between the two occlusion elements, the shunt fluidly connected to the arterial access sheath at an exit port of the arterial access sheath.

19. A system as in claim 14, wherein the dilator comprises a tapered distal end.

20. A system as in claim 14, wherein the dilator is positioned within the lumen of the arterial access sheath.

21. A system as in claim 14, wherein the dilator is sufficiently rigid that it need not be inserted into the carotid artery over a guidewire.

22. A system as in claim 14, wherein the arterial access sheath has sufficient rigidity to be introduced into the common carotid artery via a transcervical incision without requiring the use of an introducer element through the incision.

35. A system as in claim 16, further comprising a second occlusion element coupled to the arterial access sheath at a position distal of the first occlusion element, wherein the second occlusion element is configured to expand and occlude the external carotid artery while the first occlusion element occludes the common carotid artery.

36. A system as in claim 16, wherein the first occlusion element is an inflatable balloon.

37. A system as in claim 16, further comprising a side opening located on the side of the sheath between the two occlusion elements and a shunt fluidly connected to the arterial access sheath at an exit port of the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

38. A system as in claim 16, wherein the dilator comprises a tapered distal end.

39. A system as in claim 16, wherein the dilator is positioned within the lumen of the arterial access sheath.

40. A system as in claim 16, wherein the dilator is sufficiently rigid that it need not be inserted into the carotid artery over a guidewire.

41. A system as in claim 16, wherein the arterial access sheath has sufficient rigidity to be introduced into the common carotid artery via a transcervical incision without requiring the use of an introducer element through the incision.

23. A method of treating a carotid artery, comprising:

forming a puncture opening through a wall of the common carotid artery;

positioning through the puncture an arterial access sheath and dilator system, wherein the arterial access sheath and dilator system comprises an arterial access sheath and a dilator inside the arterial access sheath, wherein the arterial access sheath comprises a first occlusion element adapted to occlude the common carotid artery and a second occlusion element distal of the first occlusion element;

removing the dilator from the arterial access sheath;

expanding the first occlusion element to occlude the common carotid artery;

positioning the second occlusion element in an external carotid artery branching from the common carotid artery;

expanding the second occlusion element to occlude the external carotid artery;

introducing a therapeutic catheter into the carotid artery through an exit port located on the side of the arterial access sheath between the first and second occlusion elements; and

treating the carotid artery.

42. A system for use in accessing and treating a carotid artery, the system comprising:

an arterial access sheath comprising a lumen extending between a proximal end and a distal end adapted to receive blood flow from a common carotid artery, and a dilator positionable within the lumen of the arterial access sheath, the arterial access sheath and dilator adapted to be collectively introduced through a puncture in the common carotid artery;

a first occlusion element coupled to the arterial access sheath at a distal region of the arterial access sheath and adapted to expand and occlude the common carotid artery;

a second occlusion element coupled to the arterial access sheath at a position distal of the first occlusion element, wherein the second occlusion element is configured to expand and occlude the external carotid artery while the first occlusion element occludes the common carotid artery; and

a side opening located on the side of the sheath between the two occlusion elements and a shunt fluidly connected to the arterial access sheath at an exit port of the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

43. A system for use in accessing and treating a carotid artery, the system comprising:

an arterial access sheath comprising a lumen extending between a proximal end and a distal end adapted to receive blood flow from a common carotid artery, and a dilator positionable within the lumen of the arterial access sheath, the arterial access sheath and dilator adapted to be collectively introduced through a puncture in the common carotid artery; and

a first occlusion element coupled to the arterial access sheath at a distal region of the arterial access sheath and adapted to expand and occlude the common carotid artery,

wherein the dilator comprises a tapered distal end.

44. A system as in claim 43, further comprising a second occlusion element coupled to the arterial access sheath at a position distal of the first occlusion element, wherein the second occlusion element is configured to expand and occlude the external carotid artery while the first occlusion element occludes the common carotid artery.

45. A system as in claim 43, further comprising a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

46. A system as in claim 45, further comprising a flow control assembly directly 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.

47. A system as in claim 43, wherein the first occlusion element is an inflatable balloon.

48. A system as in claim 46, further comprising a side opening located on the side of the sheath between the two occlusion elements and a shunt fluidly connected to the arterial access sheath at an exit port of the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

49. A system as in claim 43, wherein the dilator is positioned within the lumen of the arterial access sheath.

50. A system as in claim 43, wherein the dilator is sufficiently rigid that it need not be inserted into the carotid artery over a guidewire.

51. A system as in claim 43, wherein the arterial access sheath has sufficient rigidity to be introduced into the common carotid artery via a transcervical incision without requiring the use of an introducer element through the incision.