Method and apparatus for treating a carotid artery

• US 20050154344A1
• Filed: 11/22/2004
• Published: 07/14/2005
• 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.
• Granted Patent: US 7,998,104 B2
• Time in Patent Office: Days
• US Class Current: 604/6.90
• 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. An apparatus for use in carotid angioplasty, said apparatus comprising:

a catheter having a distal end and a proximal end opposite said distal end;

first and second occlusive members, at least said first occlusive member located on said catheter, said first and second occlusive members configured to reverse the natural direction of blood flow in the internal carotid artery when said first occlusive member occludes the common carotid artery and said second occlusive member occludes the external carotid artery;

wherein said catheter has a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a maximum cross-section sized to be insertable into the common carotid artery, said first shaft portion having a relatively short length suitable for transcervical access to the common carotid artery;

wherein said catheter has a blood entry port located distal of said first occlusive member;

further comprising a collection reservoir, configured to be connected to said catheter and placed in passive fluid communication with said blood entry port.

2. The apparatus of claim 1, wherein said first shaft portion having a length of no greater than about 75 centimeters.

3. The apparatus of claim 1, wherein passive fluid communication comprises communication via a fluid flow path from said blood entry port to said collection reservoir without the assistance of fluid pressure sources other than arterial blood pressure.

4. The apparatus of claim 1, wherein said second occlusive member is located on said catheter distal of said first occlusive member.

5. The apparatus of claim 4, wherein said blood entry port is located on said catheter between said first and second occlusive members.

6. The apparatus of claim 1, further comprising a filter configured to filter the blood collected in said collection reservoir.

7. The apparatus of claim 1, further comprising an arterial return line in fluid communication with said collection reservoir.

8. A kit comprising the apparatus of claim 1.

9. A method of treating a lesion in a carotid artery in a patient, said method comprising:

inserting a catheter into the carotid vasculature via a transcervical approach;

occluding blood flow in the common carotid artery and the external carotid artery, thus reversing the direction of natural blood flow in the internal carotid artery;

allowing blood to flow into a blood entry port in said catheter; and

passively collecting the blood in a reservoir.

10. The method of claim 9, further comprising filtering the blood after collecting it in a collection reservoir.

11. The method of claim 9, further comprising returning said collected blood to said patient via an artery.

12. The method of claim 9, further comprising returning said collected blood to said patient via said catheter while said catheter remains in the carotid vasculature.

13. The method of claim 9, further comprising inserting a stent through the catheter to the treatment site and expanding the stent to treat the lesion.

14. The method of claim 9, further comprising inserting a stent through the catheter to the treatment site and contacting the lesion with the stent.

15. The method of claim 9, wherein passively collecting comprises allowing said blood to flow into said reservoir without the assistance of fluid pressure sources other than arterial blood pressure.

16. The method of claim 9, wherein said catheter comprises a first balloon which is employed to occlude the common carotid artery and a second balloon which is employed to occlude the external carotid artery.

17. An apparatus for use in carotid angioplasty, said apparatus comprising:

a catheter having a distal end and a proximal end opposite said distal end;

first and second occlusive members, at least said first occlusive member located on said catheter, said first and second occlusive members configured to reverse the natural direction of blood flow in the internal carotid artery when said first occlusive member occludes the common carotid artery and said second occlusive member occludes the external carotid artery;

wherein said catheter has a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a maximum cross-section sized to be insertable into the common carotid artery, said first shaft portion having a relatively short length suitable for transcervical access to the common carotid artery;

wherein said catheter has a blood entry port located distal of said first occlusive member;

further comprising a passive fluid conduit and a collection reservoir, said collection reservoir configured to be connected to said catheter via said passive fluid conduit.

18. The apparatus of claim 17, wherein said first shaft portion has a length of no greater than about 75 centimeters.

19. The apparatus of claim 17, wherein said collection reservoir is in passive fluid communication with said blood entry port when said passive fluid conduit is connected to said catheter and said collection reservoir is connected to said passive fluid conduit.

20. The apparatus of claim 19, wherein passive fluid communication comprises communication via a fluid flow path from said blood entry port to said collection reservoir without the assistance of fluid pressure sources other than arterial blood pressure.

21. A kit comprising the apparatus of claim 17.