# US 12,685,844 B2 · Guidewire with elastically articulatable tip

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- Number: US 12,685,844 B2
- Document ID: US12685844B2
- Status: Granted
- Kind: B2
- Application number: 17/767,553
- Filed: 2020-10-16
- Published: 2022-12-22
- Granted: 2026-07-21
- Earliest claimed: 2019-10-16
- Assignees: Embrace Medical Ltd
- Applicants: Embrace Medical Ltd
- Inventors: Michael Gabriel Tal
- Web page: https://patentgrep.com/patent/US12685844B2

## CPC

- A61M 25/09: Guide wires
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61B 1/01: Guiding arrangements therefore
- A61M 2025/09083: {having a coil around a core}
- A61M 2025/0915: {having features for changing the stiffness}
- A61M 2025/09175: {having specific characteristics at the distal tip}
- A61M 2025/09191: {made of twisted wires}
- A61M 2039/0235: {having an additional inlet, e.g. for a guidewire or a catheter tube}
- 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 guidewire for vascular access has an elastically articulatable tip configured to minimize risk of vessel wall damage during initial insertion of the guidewire into the vasculature of a patient. The guidewire may have a local flexible portion in a tip segment of the guidewire and/or a core thereof.

## Claims

### Claim 1

A guidewire for transluminal routing of artifacts in a blood vessel, comprising:
a guidewire body comprising an elastic core member extending along at least most of the length of the guidewire body, the guidewire body comprising a guidewire proximal segment, a tip segment and a guidewire intermediate segment extending between the guidewire proximal segment and the tip segment;
wherein resistance to bending of the guidewire intermediate segment along at least most of the length thereof is smaller than resistance to bending along at least most of the length of the guidewire proximal segment;
wherein the tip segment includes a local flexing portion having a resistance to bending smaller than (1) the resistance to bending of the guidewire intermediate segment, (2) of a front portion of the tip segment extending to distally from the local flexing portion, and (3) of a rear portion of the tip segment extending proximally from the local flexing portion, thereby affecting localized elastic articulatability of the front portion of the tip segment relative to the rear portion of the tip segment and/or to the guidewire intermediate segment;
wherein the elastic core member has a diameter that reduces from a first diameter proximal to a narrowing to a second diameter smaller than the first diameter distal to the narrowing; and
wherein the elastic core member comprises a widening proximal to the local flexing portion, wherein the widening increases the elastic core member diameter from a third diameter proximal to the widening to a fourth diameter greater than the third diameter distal to the widening.

### Claim 2 (depends on 1)

The guidewire according to claim 1, wherein the local flexing portion is configured to facilitate and cause elastically recoverable buckling of the rear portion of the tip segment upon longitudinal compression of the guidewire body against a blood vessel wall, when the front portion of the tip segment is forcefully articulated relative to the rear portion of the tip segment.

### Claim 3 (depends on 1)

The guidewire according to claim 1, wherein the tip segment is 20 mm or less in total length.

### Claim 4 (depends on 1)

The guidewire according to claim 1, wherein the tip segment is 10 mm or less in total length.

### Claim 5 (depends on 1)

The guidewire according to claim 1, wherein the tip segment is 5 mm or less in total length.

### Claim 6 (depends on 1)

The guidewire according to claim 1, wherein the local flexing portion includes at least one of a slit, a joint, an indentation, a coiled segment, or any combination thereof.

### Claim 7 (depends on 1)

The guidewire according to claim 1, wherein the third core member diameter is equal to or smaller than the second core member diameter and/or the fourth core member diameter is equal to the first core member diameter.

### Claim 8 (depends on 1)

The guidewire according to claim 1, wherein the elastic core member is embedded in a matrix of flexible material between the narrowing and the widening of the elastic core member, such that an overall diameter of the guidewire body along at least most of the length of the guidewire intermediate segment is equal to the first diameter.

### Claim 9 (depends on 1)

The guidewire according to claim 1, wherein the elastic core member is covered with a cylindrical coiled member between the narrowing and the widening of the elastic core member, such that an overall diameter of the guidewire body along at least most of the length of the guidewire intermediate segment is equal to the first diameter.

### Claim 10 (depends on 9)

The guidewire according to claim 9, wherein the cylindrical coiled member is formed of a spring or elastic metal alloy and is fixated to the elastic core member at or adjacent to the narrowing or at or adjacent to the widening.

### Claim 11 (depends on 1)

The guidewire according to claim 1, wherein the core member incorporates the flexing portion along the tip segment.

### Claim 12 (depends on 1)

The guidewire according to claim 1, wherein the local flexing portion has a length along the guidewire body that is equal to or smaller than 5 mm.

### Claim 13 (depends on 1)

The guidewire according to claim 1, wherein the local flexing portion has a length along the guidewire body of equal to or smaller than 3 mm.

### Claim 14 (depends on 1)

The guidewire according to claim 1, wherein the local flexing portion is equal to or smaller than 1 mm.

### Claim 15 (depends on 1)

The guidewire according to claim 1, wherein the elastic core member is formed of a selectively heat-treated shape memory alloy.

### Claim 16 (depends on 15)

The guidewire according to claim 15, wherein a portion of the elastic core member is heat-treated by exposure to a temperature of about 500° C. or less during a period of about 1 minute or less.

### Claim 17 (depends on 16)

The guidewire according to claim 16, wherein the exposure precedes fixation of a distal end of a coiled member to the elastic core member distally to the local flexing portion.

### Claim 18 (depends on 1)

The guidewire according to claim 1, wherein the resistance to bending of the local flexing portion increases when an angle formed between the front portion of the tip segment and the rear portion of the tip segment reduces.

### Claim 19 (depends on 18)

The guidewire according to claim 18, wherein a minimally allowed articulation angle between the front portion of the tip segment and the rear portion of the tip segment is between 150° and 90°.

### Claim 20 (depends on 19)

The guidewire according to claim 19, wherein the minimally allowed articulation angle is between 135° and 95°.

### Claim 21 (depends on 1)

The guidewire according to claim 1, wherein a total length of the local flexing portion is 0.5 mm or less.

### Claim 22 (depends on 1)

The guidewire according to claim 1, wherein a diameter of the local flexing portion is equal to a diameter of the rear portion of the tip segment and/or to the guidewire intermediate segment.

### Claim 23 (depends on 1)

The guidewire according to claim 1, wherein a center of the local flexing portion is 5 mm or less from a distal end of the guidewire body.

### Claim 24 (depends on 1)

The guidewire according to claim 1, wherein a center of the local flexing portion is 1 mm or less from a distal end of the guidewire body.

### Claim 25

A kit comprising:
a guidewire comprising a guidewire body having a guidewire proximal segment, a tip segment and a guidewire intermediate segment extending between the guidewire proximal segment and the tip segment; and
a needle comprising a beveled opening distally adjacent to a distal needle tip;
wherein resistance to bending of the guidewire intermediate segment along at least most of the length thereof is smaller than resistance to bending along at least most of the length of the guidewire proximal segment;
wherein the tip segment includes a local flexing portion having resistance to bending smaller than (1) the resistance to bending of the guidewire intermediate segment, (2) of a front portion of the tip segment extending to distally from the local flexing portion, and (3) of a rear portion of the tip segment extending proximally from the local flexing portion, thereby affecting localized elastic articulatability of the front portion of the tip segment relative to the rear portion of the tip segment and/or to the guidewire intermediate segment;
wherein the beveled opening has a length configured such that when the front portion of the tip segment is pushed against a blood vessel wall, the front portion is configured to articulate about the local flexing portion upon axial protrusion from the beveled opening.

### Claim 26 (depends on 25)

The kit according to claim 25, wherein the beveled opening is equal to or greater by up to 2 mm than the front portion in length.

### Claim 27 (depends on 25)

The kit according to claim 25, wherein the beveled opening is equal to or smaller by up to 2 mm than the front portion in length.

### Claim 28

A guidewire for transluminal routing of artifacts in a blood vessel, comprising:
a guidewire body comprising a guidewire proximal segment, a tip segment and a guidewire intermediate segment extending between the guidewire proximal segment and the tip segment;
wherein resistance to bending of the guidewire intermediate segment along at least most of the length thereof is smaller than resistance to bending along at least most of the length of the guidewire proximal segment;
wherein the tip segment includes a local flexing portion having resistance to bending smaller than the resistance to bending of (1) the guidewire intermediate segment, (2) of a front portion of the tip segment extending to distally from the local flexing portion, and (3) of a rear portion of the tip segment extending proximally from the local flexing portion, thereby affecting localized elastic articulatability of the front portion of the tip segment relative to the rear portion of the tip segment and/or to the guidewire intermediate segment;
wherein the resistance to bending of the local flexing portion is smaller than resistance to penetration of a wall of the blood vessel with the tip segment when the front portion of the tip segment and the rear portion of the tip segment are aligned, and/or
wherein the resistance to bending of the local flexing portion is greater than a resistance to buckling of the rear portion of the tip segment when the front and the rear portions of the tip segment form a minimally allowed articulation angle therebetween.

### Claim 29 (depends on 28)

The guidewire according to claim 28, wherein the local flexing portion is about 3 mm or less in length and distant about 5 mm or less from a distal end of the guidewire body.

### Claim 30 (depends on 28)

The guidewire according to claim 28, wherein the resistance to bending of the local flexing portion is smaller than resistance to penetration of a wall of the blood vessel with the tip segment when the front portion of the tip segment and the rear portion of the tip segment are aligned.

### Claim 31 (depends on 29)

The guidewire according to claim 29, wherein the resistance to bending of the local flexing portion is greater than a resistance to buckling of the rear portion of the tip segment when the front and the rear portions of the tip segment form a minimally allowed articulation angle therebetween.
