# US 10,864,357 B2 · Methods and devices for transcarotid access

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- Number: US 10,864,357 B2
- Document ID: US10864357B2
- Status: Granted
- Kind: B2
- Application number: 16/056,208
- Filed: 2018-08-06
- Published: 2019-06-13
- Granted: 2020-12-15
- Earliest claimed: 2014-09-04
- Assignees: Silk Road Medical, Inc.
- Applicants: Silk Road Medical, Inc.
- Inventors: Stewart M. Kume; Michi E. Garrison; Michael P. Wallace; Herbert Mendoza; Marlon Moreno
- Web page: https://patentgrep.com/patent/US10864357B2

## CPC

- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 25/0662: {Guide tubes}
- A61M 25/09: Guide wires
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/24: Check- or non-return valves
- A61B 2017/22034: {for gripping the obstruction or the tissue part from inside}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2025/0687: {having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed is an arterial access sheath for introducing an interventional device into an artery. The arterial access sheath includes an elongated body sized and shaped to be transcervically introduced into a common carotid artery at an access location in the neck and an internal lumen in the elongated body having a proximal opening in a proximal region of the elongated body and a distal opening in a distal region of the elongated body. The internal lumen provides a passageway for introducing an interventional device into the common carotid artery when the elongated body is positioned in the common carotid artery. The elongated body has a proximal section and a distalmost section that is more flexible than the proximal section. A ratio of an entire length of the distalmost section to an overall length of the sheath body is one tenth to one half the overall length of the sheath body.

## Claims

### Claim 1

A method for introducing an interventional device into a common carotid artery, the method comprising:
introducing an arterial access sheath and an elongated first dilator into a common carotid artery via an access site while the first dilator is positioned within the arterial access sheath, and wherein:
a) the arterial access sheath includes a sheath body defining an internal delivery lumen; and
b) the first dilator has a tapered distal tip and a first internal guidewire lumen, wherein at least a portion of the first dilator has a first bending stiffness;
removing the first dilator from the arterial access sheath; and
introducing an elongated second dilator into the internal delivery lumen while the sheath body is positioned within the common carotid artery, the second dilator having a tapered distal tip and a second internal guidewire lumen, wherein the second dilator has a distal region having a second bending stiffness less than the first bending stiffness of the first dilator.

### Claim 2 (depends on 1)

A method as in claim 1, wherein the first dilator has a distal section that is more flexible than a proximal section of the first dilator so as to accommodate a steep insertion angle into an artery.

### Claim 3 (depends on 2)

A method as in claim 2, wherein the distal section of the first dilator is 2 to 5 cm in length.

### Claim 4 (depends on 2)

A method as in claim 2, wherein the distal section of the first dilator is 20% to 50% more flexible than the proximal section of the first dilator.

### Claim 5 (depends on 1)

A method as in claim 1, wherein the distal region of the second dilator is more flexible than a distal section of the first dilator.

### Claim 6 (depends on 1)

A method as in claim 1, wherein the distal region of the second dilator is 2 to 5 cm in length.

### Claim 7 (depends on 1)

A method as in claim 1, wherein the distal region of the second dilator is 20% to 50% more flexible than a proximal region of the second dilator.

### Claim 8 (depends on 1)

A method as in claim 1, wherein the second dilator has an intermediate mid portion that provides a smooth transition in stiffness between a proximal region of the second dilator and the distal region of the second dilator.

### Claim 9 (depends on 1)

A method as in claim 1, wherein a distal region of the first dilator has a bending stiffness in the range of 50 to 100 N-mm2 and the distal region of the second dilator has a bending stiffness in the range of 5 to 15 N-mm2.

### Claim 10 (depends on 1)

A method as in claim 1, further comprising a radiopaque tip marker on at least one of the first and second dilators.

### Claim 11 (depends on 1)

A method as in claim 1, wherein the second internal guidewire lumen has a diameter that is smaller than a diameter of the first internal guidewire lumen.

### Claim 12 (depends on 1)

A method as in claim 1, wherein the first internal guidewire lumen accommodates a guidewire of 0.035 to 0.038 inch in diameter and the second internal guidewire lumen accommodates a guidewire of 0.014 to 0.018 inch in diameter.

### Claim 13 (depends on 1)

A method as in claim 1, wherein a proximal region of at least one of the first dilator and the second dilator includes a hub having a side opening that provides access to the internal lumen of the respective dilator to permit insertion and removal of a guidewire into or from the internal lumen of the respective dilator.

### Claim 14 (depends on 13)

A A method as in claim 13, wherein the hub includes a sleeve that moves between a first position that covers the side opening and a second position that does not cover the side opening.

### Claim 15 (depends on 1)

A method as in claim 1, wherein the second dilator is a two-part dilator formed of an outer dilator and one or more inner dilators that slidably attach to the outer dilator in a co-axial arrangement.

### Claim 16 (depends on 15)

A method as in claim 15, wherein the outer dilator accommodates a guidewire of 0.035 to 0.038 inch in diameter and inner dilator accommodates a guidewire of 0.014 to 0.018 inch in diameter.

### Claim 17 (depends on 15)

A method as in claim 15, wherein the inner and outer dilators include proximal hubs that lock to one another to lock the inner and outer dilators to one another.

### Claim 18 (depends on 15)

A method as in claim 15, wherein at least one of the inner dilators has an angled tip that angles away from a longitudinal axis of the respective dilator.

### Claim 19 (depends on 1)

A method as in claim 1, wherein the sheath body has a proximal section and a distalmost section that is more flexible than the proximal section, and wherein a ratio of an entire length of the distalmost section to an overall length of the sheath body is one tenth to one half the overall length of the sheath body.

### Claim 20 (depends on 1)

A method as in claim 1, wherein the sheath body has a proximal section and a distalmost section that is more flexible than the proximal section, and wherein the distalmost section is 2.5 to 5 cm in length and the overall sheath body is 20 to 30 cm in length.

### Claim 21 (depends on 1)

A method as in claim 1, wherein the sheath body has a proximal section and a distalmost section that is more flexible than the proximal section and a transition section between the distalmost flexible section and the proximal section, and wherein the distalmost section is 2.5 to 5 cm in length the transition section is 2 to 10 cm in length, and the overall sheath body is 20 to 30 cm in length.

### Claim 22 (depends on 1)

A method as in claim 1, wherein at least one of the first and second dilators is configured to lock to the arterial access sheath when positioned in the internal lumen of the arterial access sheath.