# US 12,478,770 B2 · Methods and devices for transcarotid access

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- Number: US 12,478,770 B2
- Document ID: US12478770B2
- Status: Granted
- Kind: B2
- Application number: 18/758,729
- Filed: 2024-06-28
- Published: 2024-12-26
- Granted: 2025-11-25
- Earliest claimed: 2014-09-04
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Stewart M. Kume; Michael Chang; Michael P. Wallace
- Web page: https://patentgrep.com/patent/US12478770B2

## 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 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- 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
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/0188: {having slitted or breakaway lumens}
- 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 2025/0915: {having features for changing the stiffness}
- A61M 2205/583: by visual feedback
- A61M 2210/12: Blood circulatory system
- 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

A micropuncture kit for direct access of a surgically exposed vessel using direct visual guidance includes a micropuncture access needle having a proximal hub coupled to an elongate shaft defining an inner lumen and a visible depth indicator positioned on the elongate shaft a distance away from a distal tip of the elongate shaft. The kit includes an access guidewire sized to be received through the inner lumen of the micropuncture access needle and a microaccess cannula having an elongate body defining an inner lumen and a plurality of visible depth indicators formed on the elongate body. The guidewire includes a distal tip and at least one visible depth indicator positioned on the access guidewire a distance away from the distal tip of the guidewire. Each of the plurality of visible depth indicators identifies a distance from a distal tip of the cannula. Related systems, devices and methods are provided.

## Claims

### Claim 1

A micropuncture kit for direct access into a lumen of a blood vessel, the kit comprising:
a micropuncture access needle comprising a proximal hub coupled to an elongate shaft defining an inner lumen and a visible depth indicator positioned on the elongate shaft a distance away from a distal tip of the elongate shaft;
a guidewire positionable through the inner lumen of the micropuncture access needle, the guidewire comprising a distal tip and at least one visible depth indicator on the guidewire a distance away from the first landmark of the guidewire; and
a microaccess cannula comprising an elongate body defining an inner lumen and a plurality of visible depth indicators formed on the elongate body, wherein each of the plurality of visible depth indicators identifies a distance from a distal tip of the cannula to a respective depth indicator;
wherein alignment of a first visible depth indicator of the at least one visible depth indicator positioned on the guidewire with a proximal edge of the cannula provides a visual indication to a user that the first landmark of the guidewire is aligned with the distal tip of the cannula;
wherein alignment of a second visible depth indicator of the at least one visible depth indicator positioned on the guidewire with a proximal edge of the cannula provides a visual indication to a user that the first landmark of the guidewire is aligned with the distal tip of the micropuncture access needle;
wherein alignment of a third visible depth indicator of the at least one visible depth indicator positioned on the guidewire with a proximal edge of the cannula provides a visual indication to a user that the first landmark of the guidewire positioned distally of the distal tip of the micropuncture access needle by a predetermined distance indicated by the third visible depth indicator.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the guidewire comprises a distalmost flexible section including the first landmark of the guidewire, a transition section proximal to the distalmost flexible section, and a stiffer core section extending proximally from the transition section.

### Claim 3 (depends on 2)

The kit of claim 2, wherein the distalmost flexible section is between 1 cm and 2 cm, and the transition section is between 2 cm and 3 cm.

### Claim 4 (depends on 2)

The kit of claim 2, wherein the transition section and the core section are configured to support the microaccess cannula inserted into the vessel.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the guidewire is in a range of 0.014″ to 0.018″ outer diameter and wherein the micropuncture needle is in a range from 21G to 24G.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the at least one visible depth indicator positioned on the guidewire has a proximal edge, a distal edge and a width extending between the proximal edge and the distal edge.

### Claim 7 (depends on 6)

The kit of claim 6, wherein the distance away from the first landmark of the guidewire is measured from the distal tip to the distal edge of the at least one visible depth indicator.

### Claim 8 (depends on 6)

The kit of claim 6, wherein inserting the guidewire through the inner lumen of the elongate shaft until the distal edge is aligned with a back end of the proximal hub of the access needle extends the first landmark of the guidewire beyond the distal tip of the elongate shaft an extension length.

### Claim 9 (depends on 8)

The kit of claim 8, wherein advancing the guidewire through the inner lumen of the elongate shaft until the proximal edge is aligned with the back end of the proximal hub of the access needle extends the first landmark of the guidewire beyond the distal tip of the elongate shaft the extension length plus the width of the at least one visible depth indicator.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the extension length is 3 cm and the width of the at least one visible depth indicator is 2 cm.

### Claim 11 (depends on 1)

The kit of claim 1, wherein the visible depth indicator of the access needle is a chemical-etched marker, a laser-etched marker, or a pad printed marker.

### Claim 12 (depends on 1)

The kit of claim 1, wherein each of the plurality of visible depth indicators is formed by a number of marks, wherein the number of marks identifies a number of increments from the distal tip of the cannula.

### Claim 13 (depends on 12)

The kit of claim 12, wherein each increment is 10 mm and the number of marks is at least one mark.

### Claim 14 (depends on 1)

The kit of claim 1, wherein a first of the plurality of visible depth indicators on the cannula comprises one mark and the first visible depth indicator is 10 mm away from the distal tip of the cannula.