Method and apparatus for treating a carotid artery

• US 7,998,104 B2
• Filed: 11/22/2004
• Issued: 08/16/2011
• 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:
  US10/996,301
• Publication Number:
  US 20050154344A1
• Time in Patent Office: 2,458 Days
• Field of Search: 604 8- 10, 604317-319, 606/200, 623/1.11, 623/1.12, 623/1.15, 623/1.16
• US Class Current: 604/9
• 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. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit, wherein 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;

a metering valve coupled to the fluid conduit, wherein the metering valve adjusts the flow rate through the fluid conduit; and

wherein said first occlusive member is located on said catheter.

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

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

5. The apparatus of claim 1, wherein said first shaft portion has a length of no greater than about 15 centimeters.

6. The apparatus of claim 1, wherein the flow sensor senses a direction of blood flow through the fluid conduit.

8. The apparatus of claim 1, wherein the collection reservoir includes an air outlet port that vents air out of the collection reservoir as blood is collected in the collection reservoir.

9. The apparatus of claim 1, wherein the flow sensor is a Doppler sensor.

4. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit that fluidly connects the catheter to a venous return sheath;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a metering valve coupled to the fluid conduit, wherein the metering valve adjusts the flow rate through the fluid conduit;

wherein said first occlusive member is located on said catheter.

7. The apparatus of claim 4, wherein the flow sensor senses a direction of blood flow through the fluid conduit.

10. The apparatus of claim 4, wherein the flow sensor is a Doppler sensor.

11. The apparatus of claim 4, wherein the flow sensor permits real time sensing of blood flow through the fluid conduit.

12. The apparatus of claim 4, wherein said first shaft portion has a length of no greater than about 15 centimeters.

13. The apparatus of claim 4, further comprising an aspiration apparatus fluidly connected to the fluid conduit, and a contrast injection reservoir fluidly coupled to the aspiration apparatus.

14. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port, wherein the collection reservoir further includes an air outlet port that vents air out of the collection reservoir as blood is collected in the collection reservoir;

a fluid conduit that fluidly connects the catheter to the collection reservoir; and

wherein said first occlusive member is located on said catheter.

15. The apparatus of claim 14, wherein the collection reservoir further includes a plunger that forces collected blood out of the collection reservoir through the blood outlet port.

25. The apparatus of claim 14, wherein said first shaft portion has a length of no greater than about 15 centimeters.

16. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit;

a filter configured to filter the blood collected in said collection reservoir; and

wherein said first occlusive member is located on said catheter.

17. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the internal carotid artery to prevent blood flow through the internal carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit, wherein the collection reservoir includes an air outlet port that vents air out of the collection reservoir as blood is collected in the collection reservoir; and

wherein said first occlusive member is located on said catheter.

18. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the internal carotid artery to prevent blood flow through the internal carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit that fluidly connects the catheter to a venous return sheath;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

an aspiration apparatus fluidly connected to the fluid conduit;

a contrast injection reservoir fluidly coupled to the aspiration apparatus;

wherein said first occlusive member is located on said catheter.

19. The apparatus of claim 18, wherein the flow sensor is a Doppler sensor.

20. The apparatus of claim 18, wherein the flow sensor permits real time sensing of blood flow through the fluid conduit.

21. The apparatus of claim 18, wherein said first shaft portion has a length of no greater than about 15 centimeters.

22. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member and wherein said second occlusive member is located on said catheter distal of said first occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit;

a metering valve coupled to the fluid conduit, wherein the metering valve adjusts the flow rate through the fluid conduit; and

wherein said first occlusive member is located on said catheter.

23. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit;

a metering valve coupled to the fluid conduit, wherein the metering valve adjusts the flow rate through the fluid conduit; and

a filter configured to filter the blood collected in said collection reservoir;

wherein said first occlusive member is located on said catheter.

24. An apparatus for use in carotid angioplasty comprising:

first and second occlusive members that reverse the natural direction of blood flow in an internal carotid artery when said first occlusive member occludes a common carotid artery and said second occlusive member occludes an external carotid artery, wherein said first occlusive member abuts a wall of the common carotid artery to prevent blood flow through the common carotid artery across the first occlusive member and wherein said second occlusive member abuts a wall of the external carotid artery to prevent blood flow through the external carotid artery across the second occlusive member;

a catheter comprising a distal end and a proximal end, a blood entry port, and a first shaft portion extending proximally from said first occlusive member, said first shaft portion having a cross-section sized to be insertable into the common carotid artery and a length of between about 2 centimeters and about 25 centimeters so as to be suitable for transcervical access to the common carotid artery;

a fluid conduit in fluid communication with the blood entry port of the catheter to permit blood to flow through the catheter into the fluid conduit;

a flow sensor connected directly to the fluid conduit wherein the flow sensor senses blood flow through the fluid conduit;

a collection reservoir comprised of a receptacle defining an enclosed chamber that collects blood and that is connected to said catheter and placed in fluid communication with said blood entry port via the fluid conduit, wherein the collection reservoir includes an air outlet port that vents air out of the collection reservoir as blood is collected in the collection reservoir; and

a metering valve coupled to the fluid conduit, wherein the metering valve adjusts the flow rate through the fluid conduit;

wherein said first occlusive member is located on said catheter.