# US 8,784,355 B2 · Methods and systems for establishing retrograde carotid arterial blood flow

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- Number: US 8,784,355 B2
- Document ID: US8784355B2
- Status: Granted
- Kind: B2
- Application number: 12/835,660
- Filed: 2010-07-13
- Published: 2010-11-04
- Granted: 2014-07-22
- Earliest claimed: 2007-07-18
- Assignees: Silk Road Medical, Inc.
- Applicants: Enrique Criado; Tony M. Chou; Michi E. Garrison; Gregory M. Hyde; Alan Schaer; Richard Renati
- Inventors: Enrique Criado; Tony M. Chou; Michi E. Garrison; Gregory M. Hyde; Alan Schaer; Richard Renati
- Web page: https://patentgrep.com/patent/US8784355B2

## CPC

- A61M 1/3655: {Arterio-venous shunts or fistulae}
- G11B 25/043: {using rotating discs}
- A61B 8/06: Measuring blood flow
- A61B 8/488: {involving Doppler signals}
- A61B 17/12045: {double occlusion, e.g. during anastomosis}
- A61B 17/12109: {in a blood vessel}
- 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)
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- 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}
- A61M 1/3613: {Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion}
- A61M 1/3659: {Cannulae pertaining to extracorporeal circulation}
- A61M 5/007: {for contrast media}
- 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})
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- 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)}
- G11B 5/4846: {Constructional details of the electrical connection between arm and support}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/12127: {Double occlusion, e.g. for creating blood-free anastomosis site}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2002/065: {Y-shaped blood vessels}
- A61F 2250/0037: differing in height or in length
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G11B: INFORMATION STORAGE BASED ON RELATIVE MOVEMENT BETWEEN RECORD CARRIER AND TRANSDUCER (recording measured values in a way that does not require playback through a transducer G01D9/00; recording or playback apparatus using mechanically marked tape, e.g. punched paper tape, or using unit records, e.g. punched or magnetically marked cards G06K; transferring data from one type of record carrier to another G06K1/18; circuits for coupling output of reproducer to radio receiver H04B1/20; gramophone pick-ups or like acoustic electromechanical transducers or circuits therefor H04R)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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 and receive blood flow from the carotid artery;
a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site; 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, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt, wherein the flow control assembly comprises two or more parallel flow paths and a valve to open or close one or more of the flow paths to adjust the state of flow by selectively directing blood flow through one or more of the flow paths.

### Claim 2 (depends on 1)

A system as in claim 1, further comprising a port fluidly communicating with the shunt, wherein the port may be used to connect an aspiration device to the shunt.

### Claim 3 (depends on 2)

A system as in claim 2, further comprising a second valve which controls fluid communication between the shunt and the port.

### Claim 4 (depends on 3)

A system as in claim 3, wherein the second valve automatically opens with attachment of an aspiration or injection device, and wherein the second valve automatically closes with removal of the aspiration or injection device.

### Claim 5 (depends on 2)

A system as in claim 2, wherein the aspiration device is a syringe, a vacuum-lock syringe, a vacuum syringe, a suction pump, or other aspiration source.

### Claim 6 (depends on 1)

A system as in claim 1, further comprising:
a fluid line communicating with the shunt, and wherein the fluid line may be used to connect an injection or aspiration device to the shunt line.

### Claim 7 (depends on 6)

A system as in claim 6, wherein a connection of the fluid line to the shunt is contained within a housing of the flow control assembly.

### Claim 8 (depends on 6)

A system as in claim 6, wherein a connection of the fluid line to the shunt is outside a housing of the flow control assembly.

### Claim 9 (depends on 6)

A system as in claim 6, wherein the flow control assembly contains an actuator adapted to open communication between the fluid line and the shunt.

### Claim 10 (depends on 9)

A system as in claim 9, wherein the actuator can be manually actuated by a user to both open and close a connection between the fluid line and the shunt.

### Claim 11 (depends on 9)

A system as in claim 9, wherein the actuator closes the shunt line towards the return site when the actuator opens the connection between the fluid line and the shunt.

### Claim 12 (depends on 9)

A system as in claim 9, wherein the actuator automatically reverts to close the fluid line connection and open the shunt connection to the return site when the aspiration is complete.

### Claim 13 (depends on 1)

A system as in claim 1, further comprising an active pump coupled to the shunt.

### Claim 14 (depends on 13)

A system as in claim 13, wherein the active pump allows passive flow when the active pump is inactive.

### Claim 15 (depends on 13)

A system as in claim 13, wherein the active pump is a roller pump, a positive displacement pump, a syringe pump, or an impeller pump.

### Claim 16 (depends on 1)

A system as in claim 1, further comprising a one-way valve coupled to the shunt, wherein the valve prevents fluid flow through the shunt in a direction towards the arterial access device.

### Claim 17

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 and receive blood flow from the carotid artery;
a shunt fluidly connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site;
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, wherein the flow control assembly comprises two or more parallel flow paths and a valve to open or close one or more of the flow paths to adjust the state of flow b selectively directing blood flow through one or more of the flow paths; and
a filter coupled to the shunt, wherein the filter filters fluid flow through the shunt.

### Claim 18 (depends on 17)

A system as in claim 17, further comprising a port fluidly communicating with the shunt, wherein the port may be used to connect an aspiration device to the shunt.

### Claim 19 (depends on 17)

A system as in claim 17, further comprising a second valve which controls fluid communication between the shunt and the port.

### Claim 20 (depends on 19)

A system as in claim 19, wherein the second valve automatically opens with attachment of an aspiration or injection device, and wherein the second valve automatically closes with removal of the aspiration or injection device.

### Claim 21 (depends on 18)

A system as in claim 18, wherein the aspiration device is a syringe, a vacuum-lock syringe, a vacuum syringe, a suction pump, or other aspiration source.

### Claim 22 (depends on 17)

A system as in claim 17, further comprising:
a fluid line communicating with the shunt, and wherein the fluid line may be used to connect an injection or aspiration device to the shunt line.

### Claim 23 (depends on 22)

A system as in claim 22, wherein a connection of the fluid line to the shunt is contained within a housing of the flow control assembly.

### Claim 24 (depends on 2)

A system as in claim 2, wherein a connection of the fluid line to the shunt is outside a housing of the flow control assembly.

### Claim 25 (depends on 22)

A system as in claim 22, wherein the flow control assembly contains an actuator adapted to open communication between the fluid line and the shunt.

### Claim 26 (depends on 25)

A system as in claim 25, wherein the actuator can be manually actuated by a user to both open and close a connection between the fluid line and the shunt.

### Claim 27 (depends on 25)

A system as in claim 25, wherein the actuator closes the shunt line towards the return site when the actuator opens the connection between the fluid line and the shunt.

### Claim 28 (depends on 25)

A system as in claim 25, wherein the actuator automatically reverts to close the fluid line connection and open the shunt connection to the return site when the aspiration is complete.

### Claim 29 (depends on 17)

A system as in claim 17, further comprising an active pump coupled to the shunt.

### Claim 30 (depends on 17)

A system as in claim 17, wherein the active pump controls are separate from a housing of the flow control assembly.

### Claim 31 (depends on 30)

A system as in claim 30, wherein the active pump allows passive flow when the active pump is inactive.

### Claim 32 (depends on 30)

A system as in claim 30, wherein the active pump is a roller pump, a positive displacement pump, a syringe pump, or an impeller pump.

### Claim 33 (depends on 17)

A system as in claim 17, further comprising a one-way valve coupled to the shunt, wherein the valve prevents fluid flow through the shunt in a direction towards the arterial access device.
