Systems and methods for treating a carotid artery

• US 8,858,490 B2
• Filed: 07/12/2010
• Issued: 10/14/2014
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Chou, Tony M., Garrison, Michi E., Hyde, Gregory M., Renati, Richard, Schaer, Alan
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/834,869
• Publication Number:
  US 20110034986A1
• Time in Patent Office: 1,555 Days
• Field of Search: 604 8- 10, 604/500, 604507-509, 604/96.01, 604/101.01, 604/101.05, 604/102.02, 604/108, 606/191, 606/192, 606/194, 606/200, 623/1.11, 600/504
• US Class Current: 604/9
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/3482 inside
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 : Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 : Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/844 : folded prior to deployment
• CPC Class Codes: A61F 2/856 : Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 : handle assemblies therefor
• CPC Class Codes: A61F 2/954 : for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 : with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/065 : Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 : modular
• CPC Class Codes: A61F 2002/9511 : the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0037 : differing in height or in length
• CPC Class Codes: A61M 1/3613 : Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3659 : Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 25/104 : used for angioplasty
• CPC Class Codes: A61M 27/00 : Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• 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

Systems and methods are adapted for treating the carotid artery. The systems include interventional catheters and blood vessel access devices that are adapted for transcervical insertion into the carotid artery. Embodiments of the systems and methods can be used in combination with embolic protection systems including blood flow reversal mechanisms, arterial filters, and arterial occlusion devices.

Claims

1. A system for treating a carotid artery, comprising:

an arterial access device wherein the access device includes a distal sheath adapted to be transcervically introduced into a carotid artery through a penetration in a wall of the carotid artery;

an interventional catheter adapted for transcervical insertion into the carotid artery via the arterial access device, wherein the interventional catheter is adapted to deploy a stent;

a first hemostasis valve positioned on a proximal end of the arterial access device;

wherein the interventional catheter is formed of;

an elongated inner member having a distal region on which the stent may be mounted, the elongated inner member further having a protrusion on a proximal portion of the elongated inner member;

an elongated stent containment sheath coaxially positioned over the inner member, the stent containment sheath formed by an annular side wall, wherein an opening is formed through a proximal portion of the annular side wall of the stent containment sheath, and wherein the protrusion of the inner member extends outward through the opening such that the protrusion of the inner member may be accessed by a user at a location outside the stent containment sheath.

2. A system as in claim 1, wherein the catheter has a working length suitable for deployment through a transcervical access sheath into the common carotid artery.

3. A system as in claim 2, wherein the working length is within the range of approximately 40 cm to 60 cm.

4. A system as in claim 3, wherein the working length is within the range of approximately 40 cm to 75 cm.

5. A system as in claim 1, further comprising a second hemostasis valve positioned on a proximal region of the arterial access device.

6. A system as in claim 1, wherein the opening in the annular side wall of the stent containment sheath is an elongated slot along which the protrusion of the inner member can be slid to achieve relative movement between the stent containment sheath and the inner member.

7. A system as in claim 1, wherein the opening in the annular side wall of the stent containment sheath is located distal of a proximal end of the stent containment sheath.

8. A system as in claim 1, wherein the protrusion of the inner member includes a tubular member that encircles a proximal region of the stent containment sheath.

9. A system as in claim 1, further comprising a securement member attached to the first hemostasis valve, wherein the securement member can be actuated to engage to the protrusion on the inner member of the interventional catheter to secure the inner member to the arterial access device.

10. A system as in claim 9, further comprising a proximal extension connected to the distal sheath and having a distal end, a proximal end, and a lumen therebetween, wherein the distal end of the proximal extension is connected to a proximal end of the distal sheath at a junction so that the lumens of each are contiguous.

11. A system as in claim 10, wherein the distal end of the proximal extension is removably connected to a proximal end of the distal sheath at the junction.

12. A system as in claim 10, wherein the proximal extension has a length from the junction to the first hemostasis valve sufficient to space the hemostasis valve away from the transcervical insertion site such that the exposure to radiation is minimized when the user introduces the interventional catheter into the arterial access device via the hemostasis valve while fluoroscopy is being performed in the area of the carotid artery.

13. A system as in claim 1, further comprising a shunt fluidly connected to the arterial access device at the junction between the proximal extension and the distal sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

14. A system as in claim 13, wherein the arterial access device is adapted to receive blood flow from the carotid artery, and further comprising:

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, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt.