Systems and methods for treating a carotid artery

• US 9,623,228 B2
• Filed: 08/05/2011
• Issued: 04/18/2017
• Est. Priority Date: 08/12/2010
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Ryan, Ari, Schaer, Alan K., Hyde, Gregory M., Renati, Richard J., Garrison, Michi E.
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US13/816,670
• Publication Number:
  US 20130197621A1
• Time in Patent Office: 2,083 Days
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• 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 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00646 Type of implements
• 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 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2039/047 the self-sealing member being a viscous fluid
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• 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 39/0606 : without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/227 : Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves
• CPC Class Codes: A61M 39/228 : with a tubular diaphragm constrictable by radial fluid force

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 use in accessing and treating a carotid artery, said system comprising:

an arterial access device adapted to be introduced into a common carotid artery, wherein the arterial access device comprises a distal sheath adapted to enter the common carotid artery, an aspiration port communicating with an internal lumen of the distal sheath, and a proximal hemostasis valve assembly providing access to the internal lumen of the distal sheath for an interventional device;

the hemostasis valve assembly comprising;

(a) a housing defining an internal chamber that communicates with the internal lumen of the distal sheath, wherein the internal chamber is adapted to contain a liquid or gel;

(b) a first seal member that seals the internal chamber from the internal lumen of the distal sheath, the first seal member having a central passageway that opens for passage of an interventional device into the internal lumen of the distal sheath from the internal chamber, wherein the central passageway is closed in a default state to prevent passage of fluid across the first seal member;

(c) wherein, when the internal chamber is filled with liquid or gel, the liquid or gel prevents air from entering the internal lumen of the distal sheath via the hemostasis valve assembly when the internal lumen of the distal sheath is aspirated, via the aspiration port;

a second seal member, wherein the second seal member is positioned on a proximal end of the internal chamber and the first seal member is positioned on a distal end of the internal chamber so that the first seal member and second seal member define the internal chamber therebetween and can enclose liquid or gel within the internal chamber, and wherein the first seal member and second seal member are aligned along a common, straight axis;

and wherein the internal chamber is pre-filled with liquid or gel prior to a first use of the arterial access device.

2. A system as in claim 1, wherein a proximal end of the internal chamber is open to atmosphere, and wherein the internal chamber has a size such that surface tension of liquid or gel in the internal chamber maintains the liquid or gel within the internal chamber.

3. A system as in claim 1, further comprising:

an interventional device adapted to be inserted through the internal chamber of the hemostasis valve assembly, across the first seal member, and into the internal lumen of the distal sheath; and

an introducer that couples to the interventional device so as to provide the interventional device with sufficient columnar stiffness to pass entirely through the internal chamber and into the hemostasis valve assembly.

4. A system as in claim 3, wherein the introducer is removably attached to the interventional device.

5. A system as in claim 3, wherein the introducer is integrally part of the interventional device.

6. A system as in claim 1, further comprising a flush port having a lumen in communication with the internal chamber of the hemostasis valve assembly, the port adapted to inject liquid or gel into the internal chamber of the hemostasis valve assembly.

7. A system as in claim 1, further comprising a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow in a retrograde direction from the arterial access device to a return site.

8. A system as in claim 7, 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.

9. A system as in claim 8, wherein the flow control assembly includes a flow resistance element adapted to adjust a resistance of blood flow through the shunt.

10. A system as in claim 1, further comprising a venous return device adapted to output blood flow wherein the venous return device is adapted to be inserted into a vein, and wherein a shunt fluidly connects the arterial access device to the venous return device such that the blood flows through the shunt from the common carotid artery to the vein.

11. A system as in claim 10, wherein the shunt is adapted to be connected to an external receptacle such that the blood flows from the common carotid artery through the shunt to the external receptacle.