# US 12,005,201 B2 · Puncture visualization device and method

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- Number: US 12,005,201 B2
- Document ID: US12005201B2
- Status: Granted
- Kind: B2
- Application number: 17/301,235
- Filed: 2021-03-30
- Published: 2021-09-30
- Granted: 2024-06-11
- Earliest claimed: 2020-03-31
- Assignees: Gyrus ACMI, Inc.
- Applicants: Gyrus Acmi, Inc.
- Inventors: Judy L. Walish; Bruce W. Flight
- Web page: https://patentgrep.com/patent/US12005201B2

## CPC

- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61M 25/065: {Guide needles}
- A61B 17/3421: {Cannulas}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0625: {with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism}
- A61M 25/09: Guide wires
- A61B 1/01: Guiding arrangements therefore
- A61B 17/3403: {Needle locating or guiding means}
- A61B 2017/22042: {Details of the tip of the guide wire}
- A61B 2090/3614: {using optical fibre}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- A61M 2205/3306: Optical measuring means
- A61M 2205/332: Force measuring means
- A61M 2205/3368: Temperature
- A61M 2205/583: by visual feedback
- A61M 2205/587: Lighting arrangements
- 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 puncture visualization device can include a guidewire having a proximal section, a distal section, and a distal tip. The device can include a needle having a needle lumen configured to receive the guidewire. The device can include a lock, and the lock can engage with the guidewire. For instance, engagement of the lock with the guidewire can inhibit relative motion between the guidewire and the needle. The device can include an optical sensor, for example located at the distal tip of the guidewire. The optical sensor can be locked into a position, for instance by the lock. In an example, the device provides a distal field of view from a location within the needle and near a distal end of the needle for visualization to facilitate puncturing a target with the distal end of the needle.

## Claims

### Claim 1

A puncture visualization device for a percutaneous puncturing procedure, the puncture visualization device comprising:
a guidewire, including:
a proximal section;
a distal section including a distal coil and a distal tip; and
an inner support engaged with the distal coil;
a needle including a needle lumen configured to receive the guidewire;
a lock configured to engage with the guidewire to inhibit relative motion between the guidewire and the needle;
an optical sensor, located at the distal tip of the guidewire, the optical sensor configured to be locked into a position by the lock to provide a distal field of view from a location within the needle and near a distal end of the needle for visualization to facilitate puncturing a target with the distal end of the needle; and
wherein the guidewire includes a first alignment feature that engages with the lock so as to define a length of the guidewire within the needle that locates the optical sensor at the distal tip of the guidewire at a location that is within the needle that is at a specified offset distance from a distal end of the needle to establish the distal field of view of the optical sensor to extend beyond the distal end of the needle.

### Claim 2 (depends on 1)

The puncture visualization device of claim 1, wherein the needle lumen is sized and shaped to receive the guidewire and inhibit reception of the first alignment feature.

### Claim 3 (depends on 1)

The puncture visualization device of claim 1, further comprising a needle hub at a proximal end of the needle and in communication with the needle lumen of the needle.

### Claim 4 (depends on 3)

The puncture visualization device of claim 3, wherein the needle hub includes:
the lock; and
an actuator configured to transition the puncture visualization device between a locked configuration and an unlocked configuration, wherein:
in the locked configuration, the lock is engaged with the guidewire; and
in the unlocked configuration, the lock is disengaged from the guidewire.

### Claim 5 (depends on 4)

The puncture visualization device claim 4, wherein the lock includes an arm configured to engage with the guidewire and bias the guidewire toward a wall of the needle lumen.

### Claim 6 (depends on 3)

The puncture visualization device of claim 3, further comprising a guidewire adaptor including the lock, wherein:
the guidewire adaptor includes an adaptor lumen configured to receive the guidewire; and
the needle hub is configured to receive the guidewire adaptor, wherein:
the guidewire adaptor is configured to engage with the needle hub to selectively couple the guidewire adaptor with the needle hub; and
the lock is configured to engage with the guidewire when the guidewire adaptor is coupled with the needle hub.

### Claim 7 (depends on 6)

The puncture visualization device of claim 6, wherein the lock is configured to compress the guidewire in the adaptor lumen to inhibit the relative motion between the guidewire and the needle when the guidewire adaptor is selectively coupled with the needle hub.

### Claim 8 (depends on 1)

The puncture visualization device of claim 1, wherein the inner support includes an inner coil.

### Claim 9 (depends on 8)

The puncture visualization device of claim 8, wherein the inner coil is wound in a first direction, and the distal coil is wound in a second direction opposite the first direction.

### Claim 10 (depends on 8)

The puncture visualization device of claim 8, wherein the inner coil defines an interior chamber and the optical sensor is located at least partially within the interior chamber defined by the inner coil.

### Claim 11 (depends on 1)

The puncture visualization device of claim 1, wherein the distal coil has a rounded profile.

### Claim 12 (depends on 1)

The puncture visualization device of claim 1, wherein the guidewire includes a light source configured to illuminate an area distal to the distal tip of the guidewire.

### Claim 13 (depends on 12)

The puncture visualization device of claim 12, wherein the guidewire includes an optical fiber providing or coupled to the light source.

### Claim 14 (depends on 1)

The puncture visualization device of claim 1, further comprising an electrical interconnect in communication with the optical sensor and included in the proximal section of the guidewire.

### Claim 15 (depends on 1)

The puncture visualization device of claim 1, further comprising one or more of a temperature sensor or a force sensor located at the distal tip of the guidewire.
