Methods and systems for establishing retrograde carotid arterial blood flow

• US 8,740,834 B2
• Filed: 03/17/2011
• Issued: 06/03/2014
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Criado, Enrique, Chou, Tony M., Garrison, Michi E., Hyde, Gregory M., Schaer, Alan, Renati, Richard
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/050,855
• Publication Number:
  US 20110166496A1
• Time in Patent Office: 1,174 Days
• Field of Search: 33 8- 10, 335/00, 33507-509, 331/010.1, 331/010.5, 331/020.2, 331/08, 606/191, 606/192, 606/194, 606/200, 623/1.11, 600/504
• US Class Current: 604/9
• 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 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/488 involving Doppler signals
• 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: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• 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 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/22 : Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: G11B 25/043 : using rotating discs
• CPC Class Codes: G11B 5/4846 : Constructional details of the electrical connection between arm and support

Abstract

Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly 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. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Claims

1. A device for use in accessing and treating a carotid artery, said device comprising:

a distal sheath having a distal section with a distal end adapted to be introduced into the common carotid artery, a proximal end, and a lumen extending between the distal and proximal ends;

a proximal extension having a distal end, a proximal end, and a lumen therebetween, wherein the distal end of the proximal extension is connected to the proximal end of the sheath at a junction so that the lumens of each are contiguous;

a flow line having a lumen, said flow line connected near the junction so that blood flowing into the distal end of the sheath can flow into the lumen of the flow line;

a hemostasis valve at the proximal end of the proximal extension, said hemostasis valve being adapted to inhibit blood flow from the proximal extension while allowing catheter introduction through the proximal extension and into the distal sheath; and

a stopper member that covers a portion of a distal section of the sheath such that a portion of the distal section of the sheath is covered by the stopper member and a portion of the distal section of the sheath is exposed, wherein the stopper member, when coupled to the sheath, limits insertion of the sheath into the carotid artery to the exposed portion, and wherein the stopper member is removable from the distal section of the sheath.

2. A device as in claim 1, further comprising a flush line connected to the proximal extension to provide access to the lumen of the proximal extension.

3. A device as in claim 1, wherein the distal sheath is circumferentially reinforced to increase hoop strength with a minimal loss of axial flexibility.

4. A device as in claim 1, further comprising a dilator having a central guide wire lumen and a tapered distal end and being removably insertable through the hemostasis valve so that the tapered distal end extends out of the distal end of the distal sheath.

5. A device as in claim 1, further comprising a tube having a central passage which is coaxially received over the distal sheath and adapted to engage an adaptor which connects the proximal end of the sheath to the distal end of the proximal extension and the distal end of the flow line.

6. A device as in claim 1, wherein the proximal extension is removably connected to the sheath at the junction.

7. A device as in claim 1, further comprising a filter coupled to the flow line, wherein the filter filters fluid flow through the flow line.

8. A device as in claim 1, further comprising a one-way valve coupled to the flow line, wherein the valve prevents fluid flow through the flow line in one direction.

9. A device for use in accessing and treating a carotid artery, said device comprising:

a distal sheath having a distal end adapted to be introduced into the common carotid artery, a proximal end, and a lumen extending between the distal and proximal ends;

a proximal extension having a distal end, a proximal end, and a lumen therebetween, wherein the distal end of the proximal extension is connected to the proximal end of the sheath at a junction so that the lumens of each are contiguous and wherein the proximal extension has a diameter that is greater than a diameter of the distal sheath;

a flow line having a lumen, said flow line connected near and proximal the junction so that blood flowing into the distal end of the sheath can flow into the lumen of the flow line; and

a stopper member that covers a portion of a distal section of the sheath such that a portion of the distal section of the sheath is covered by the stopper member and a portion of the distal section of the sheath is exposed, wherein the stopper member, when coupled to the sheath, limits insertion of the sheath into the carotid artery to the exposed portion, and wherein the stopper member is removable from the distal section of the sheath.

10. A device as in claim 9, further comprising a flush line connected to the proximal extension to provide access to the lumen of the proximal extension.

11. A device as in claim 9, wherein the distal sheath is circumferentially reinforced to increase hoop strength with a minimal loss of axial flexibility.

12. A device as in claim 9, further comprising a dilator having a central guide wire lumen and a tapered distal end and being removably insertable through the hemostasis valve so that the tapered distal end extends out of the distal end of the distal sheath.

13. A device as in claim 9, wherein the proximal extension is removably connected to the sheath at the junction.