Method and apparatus for treating a carotid artery

• US 8,002,728 B2
• Filed: 07/18/2008
• Issued: 08/23/2011
• 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:
  US12/176,282
• Publication Number:
  US 20090018455A1
• Time in Patent Office: 1,131 Days
• Field of Search: 604/8, 604/9, 606/200, 623/1.11, 623/1.12, 623/1.15, 623/1.16, 623/1.2
• US Class Current: 604/6.15
• 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 dilating A61M29/02
• 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 system for use in treating a carotid artery, comprising:

an arterial access device adapted to be introduced into a common carotid artery, the arterial access device having a lumen that extends from a distal opening at a distal region of the arterial access device to a proximal opening at a proximal region of the arterial access device, the lumen configured for receiving retrograde blood flow through the distal opening from the common carotid artery;

a shunt having an internal shunt lumen fluidly connected to the lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device, wherein the internal shunt lumen provides a pathway for blood to flow out of the internal lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device; and

a flow control mechanism coupled to the shunt and adapted to control blood flow through the shunt.

2. A system as in claim 1, wherein the flow control mechanism comprises a pump connected to the internal shunt lumen.

3. A system as in claim 1, wherein the flow control mechanism comprises an aspiration apparatus connected to the internal shunt lumen.

4. A system as in claim 1, further comprising a filter attached to the internal shunt lumen and adapted to filter blood flowing through the internal shunt lumen.

5. A system as in claim 1, further comprising a flow sensor coupled to the shunt and adapted to sense a state of blood flow through the internal shunt lumen of the shunt.

6. A system as in claim 5, wherein the flow sensor senses a direction of blood flow through the shunt.

7. A system as in claim 5, wherein the sensor comprises a Doppler sensor.

8. A system as in claim 1, further comprising a venous return device fluidly coupled to the shunt at a location opposite a location where the shunt is fluidly connected to the arterial access device, wherein the venous return device is adapted to be introduced into a vein.

13. A system as in claim 1, further comprising a venous return device fluidly coupled to the shunt at a location opposite a location where the shunt is fluidly connected to the arterial access device, wherein the venous return device is adapted to be introduced into a vein.

22. A system as in claim 1, wherein a sidearm extends outward from the arterial access device at a location between the distal and proximal openings of the arterial access device and forms a connection between the arterial access device and the shunt.

23. A system as in claim 1, wherein the flow control mechanism is coupled directly to the shunt.

9. A system for use in treating a carotid artery, comprising:

an arterial access device adapted to be introduced into a common carotid artery the arterial access device having a lumen that extends from a distal opening at a distal region of the arterial access device to a proximal opening at a proximal region of the arterial access device, the lumen configured for receiving retrograde blood flow through the distal opening from the common carotid artery;

a shunt having an internal shunt lumen fluidly connected to the lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device, wherein the internal shunt lumen provides a pathway for blood to flow out of the internal lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device; and

a flow sensor coupled to the shunt and adapted to sense a state of retrograde flow through the internal shunt lumen.

10. A system as in claim 9, wherein the flow sensor senses a direction of blood flow through the internal shunt lumen.

11. A system as in claim 9, wherein the sensor comprises a Doppler sensor.

12. A system as in claim 9, further comprising a filter attached to the internal shunt lumen and adapted to filter blood flowing through the internal shunt lumen.

24. A system as in claim 9, wherein a sidearm extends outward from the arterial access device at a location between the distal and proximal openings of the arterial access device and forms a connection between the arterial access device and the shunt.

25. A system as in claim 9, wherein the flow sensor is coupled directly to the internal shunt lumen.

14. A method for accessing an internal carotid artery, comprising:

positioning an arterial access device in a common carotid artery via a transcervical approach;

establishing retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access device; and

causing retrograde blood flow from the lumen of the arterial access device into an internal shunt lumen of a shunt connected to the arterial access device, wherein

the arterial access device comprises an elongate member defining the lumen of the arterial access device, and wherein the lumen of the arterial access device extends from a distal opening at a distal region of the arterial access device to a proximal opening at a proximal region of the arterial access device, the lumen of the arterial access device configured for receiving retrograde blood flow through the distal opening from the common carotid artery; and

wherein the shunt comprises a sidearm connected to the arterial access device at a location between the distal and proximal openings of the arterial access device, and wherein the internal shunt lumen provides a pathway for blood to flow out of the internal lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device; and

controlling the flow of blood through the shunt.

15. A method as in claim 14, wherein controlling blood flow through the shunt comprises operating a pump coupled to the internal shunt lumen.

16. A method as in claim 14, wherein controlling blood flow through the shunt comprises operating an aspiration apparatus coupled to the internal shunt lumen.

17. A method as in claim 14, further comprising sensing a state of blood flow through the internal shunt lumen.

18. A method as in claim 17, wherein sensing a state of blood flow through the internal shunt lumen comprises using a Doppler sensor to sense the state of blood flow through the shunt.

26. A method as in claim 14, wherein establishing retrograde blood flow through the common carotid artery comprises occluding the common carotid artery.

27. A method as in claim 26, wherein the arterial access device includes an expandable member, and wherein occluding the common carotid artery comprises expanding the expandable member to a size that occludes the common carotid artery.

28. A method as in claim 14, wherein a sidearm extends outward from the arterial access device and forms a connection between the arterial access device and the shunt.

29. A method as in claim 14, wherein causing retrograde blood flow from the lumen of the arterial access device into an internal shunt lumen of a shunt connected to the arterial access device comprises causing blood to exit the arterial access device through the internal shunt lumen.

19. A method for accessing an internal carotid artery, comprising:

positioning an arterial access device in a common carotid artery via a transcervical approach;

establishing retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access device; and

causing retrograde blood flow from the lumen of the arterial access device into an internal shunt lumen of a shunt connected to the arterial access device at a location between the distal and proximal openings of said arterial access device, wherein the arterial access device comprises an elongate member defining the lumen of the arterial access device, and wherein the lumen of the arterial access device extends from a distal opening at a distal region of the arterial access device to a proximal opening at a proximal region of the arterial access device, the lumen of the arterial access device configured for receiving retrograde blood flow through the distal opening from the common carotid artery; and

wherein the shunt comprises a sidearm connected to the arterial access device at a location between the distal and proximal openings of the arterial access device, and wherein the internal shunt lumen provides a pathway for blood to flow out of the internal lumen of the arterial access device at a location between the distal and proximal openings of the arterial access device; and

sensing a state of blood flow through the internal shunt lumen.

20. A method as in claim 19, wherein sensing a state of blood flow through the internal shunt lumen comprises using a Doppler sensor to sense the state of blood flow through the shunt.

21. A method as in claim 19, further comprising controlling the blood flow through the internal shunt lumen.

30. A method as in claim 19, wherein establishing retrograde blood flow through the common carotid artery comprises occluding the common carotid artery.

31. A method as in claim 30, wherein the arterial access device includes an expandable member, and wherein occluding the common carotid artery comprises expanding the expandable member to a size that occludes the common carotid artery.

32. A method as in claim 19, wherein a sidearm extends outward from the arterial access device and forms a connection between the arterial access device and the shunt.

33. A method as in claim 19, wherein causing retrograde blood flow from the lumen of the arterial access device into an internal shunt lumen of a shunt connected to the arterial access device comprises causing blood to exit the arterial access device through the internal shunt lumen.