Method and apparatus for treating a carotid artery

• US 8,414,516 B2
• Filed: 04/01/2010
• Issued: 04/09/2013
• 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:
  US12/753,039
• Publication Number:
  US 20100191170A1
• Time in Patent Office: 1,104 Days
• Field of Search: 604 8- 10, 604/103.1, 604/509, 604/523
• 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 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 method of treating a lesion in a carotid artery of a patient having an arterial blood system and a venous blood system, comprising:

percutaneously accessing a common carotid artery transcervically;

percutaneously positioning an arterial access device in the common carotid artery, wherein the arterial access device comprises a distal insertable length;

occluding blood flow in at least a portion of the common carotid artery to establish retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access device;

shunting blood from the common carotid artery to the venous system of the patient via the arterial access device and 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

treating the lesion by deploying a stent on the lesion.

2. The method of claim 1, wherein the arterial access device is fluidically connected to a shunt device.

3. The method of claim 1, further comprising controlling blood flow through the arterial access device.

4. The method of claim 3, wherein controlling blood flow comprises controlling passive blood flow through the arterial access device.

5. The method of claim 3, wherein controlling blood flow comprises enabling active blood flow through the arterial access device.

6. The method of claim 3, wherein controlling blood flow comprises using a metering valve installed in a shunt device fluidically connected to the arterial access device to adjust a rate of blood flow from the arterial access device into the shunt device.

7. The method of claim 3, wherein controlling blood flow comprises using a syringe fluidically connected to the arterial access device to aspirate the blood from the arterial access device.

8. The method of claim 3, wherein controlling blood flow through the arterial access device comprises using a pump fluidically connected to the arterial access device to adjust a rate of blood flow from the arterial access device.

9. The method of claim 1, further comprising occluding blood flow through at least a portion of an external carotid artery.

10. The method of claim 1, wherein occluding blood flow in at least a portion of the common carotid artery comprises occluding the common carotid artery at a location to disrupt natural blood flow, wherein a blood inlet port of the arterial access device is positioned in the common carotid artery above the location.

11. The method of claim 1, wherein occluding blood flow in a portion of the common carotid artery facilitates shunting of blood from the common carotid artery to the venous system of the patient.

12. The method of claim 1, further comprising filtering the blood from the common carotid artery prior to shunting the blood to the venous system using a filter.

13. The method of claim 12, further comprising sensing the flow of blood being shunted from the common carotid artery to the venous system using a flow sensor.

14. The method of claim 1, wherein percutaneously positioning an arterial access device in the common carotid artery further comprises deploying an anchor element on the arterial access device, wherein the anchor element prevents the arterial access device from dislodging from the common carotid artery.

15. The method of claim 14, wherein the anchor element further occludes blood flow in the at least a portion of the common carotid artery.

16. The method of claim 1, further comprising imparting a bent shape to at least a portion of the distal insertable length prior to positioning the arterial access device in the common carotid artery.

17. The method of claim 16, wherein the at least a portion of the distal insertable length is generally rigid but sufficiently malleable to maintain the bent shape during positioning in the common carotid artery.

18. The method of claim 1, wherein the distal insertable length of the arterial access device further comprises a dilator having a distal tip, wherein the dilator comprises a short taper angled towards the distal tip to prevent injury to a wall of the common carotid artery.

19. The method of claim 1, wherein the distal insertable length is less than 15 cm.

20. The method of claim 1, wherein shunting the blood from the common carotid artery to the venous system comprises shunting to a jugular vein of the patient.

21. The method of claim 1, wherein the patient is under mild sedation.

22. The method of claim 1, further comprising filtering the blood.