# US 10,765,836 B1 · Electronic guidewire detector for catheter insertion

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- Number: US 10,765,836 B1
- Document ID: US10765836B1
- Status: Granted
- Kind: B1
- Application number: 16/368,464
- Filed: 2019-03-28
- Published: 2020-10-01
- Granted: 2020-09-08
- Earliest claimed: 2019-03-28
- Assignees: Horizon Patents, LLC
- Applicants: Horizon Patents, LLC.
- Inventors: Mark M. Gottlieb; James B. Solomon
- Web page: https://patentgrep.com/patent/US10765836B1

## CPC

- A61M 25/09: Guide wires
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 25/0127: {Magnetic means; Magnetic markers}
- A61B 2017/00119: {alarm; indicating an abnormal situation}
- A61B 2017/00128: {related to intensity or progress of surgical action}
- A61B 2017/00734: {battery operated}
- A61B 2034/2059: {Mechanical position encoders}
- A61B 2090/0804: {Counting number of instruments used; Instrument detectors}
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2205/3306: Optical measuring means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/581: by audible feedback
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- 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 detector and a method of its use with a guidewire to reduce the incidence of guidewires accidently being left inside patients during the placement of central venous (and other) catheters. In particular, an electronic detector detects whether a catheter has been placed over a guidewire and whether the guidewire has been removed thereafter. In addition, the distance the guidewire has progressed out the patient side of the detector housing which will correspond to the length of guidewire actually inside the patient and any time may be provided.

## Claims

### Claim 1

A detector for a guidewire to be used with a catheter, comprising:
a housing including a passageway having a first opening on a patient side of the housing and a second opening on a caregiver side of the housing; and
circuitry contained within the housing for detecting and indicating: (1) that a first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and a second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 2 (depends on 1)

The detector as claimed in claim 1, further comprising:
at least one LED, wherein the circuitry for indicating: (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side comprises circuitry for illuminating the at least one LED to indicate: (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 3 (depends on 1)

The detector as claimed in claim 1, further comprising:
first and second LEDs, wherein the circuitry for indicating: (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side comprises:
circuitry for illuminating the first LED to indicate that the first end of the guidewire has entered the housing through the first opening on the patient side;
circuitry for illuminating the second LED to indicate that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 4 (depends on 1)

The detector as claimed in claim 1, further comprising:
a speaker, wherein the circuitry for indicating: (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side comprises circuitry for playing at least one sound through the speaker to indicate: (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 5 (depends on 4)

The detector as claimed in claim 4, wherein the circuitry (a) plays the at least one sound to indicate that the second end of the guidewire has entered the housing through the first opening on the patient side and (b) stops playing the at least one sound to indicate that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 6 (depends on 4)

The detector as claimed in claim 4, wherein the circuitry (a) periodically plays the at least one sound to indicate that the first end of the guidewire has entered the housing through the first opening on the patient side and (b) stops periodically playing the at least one sound to indicate that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 7 (depends on 1)

The detector as claimed in claim 1, further comprising a guidewire passage tube, wherein the circuitry for detecting and indicating comprises a light transmitter for transmitting light at a selected frequency and first and second light detectors to detect (1) that the guidewire is blocking light from the light transmitter from reaching the first light detector and (2) that the guidewire is blocking light from the light transmitter from reaching the second light detector.

### Claim 8 (depends on 7)

The detector as claimed in claim 7, wherein the selected frequency is in the 630 nm to 700 nm range.

### Claim 9 (depends on 1)

The detector as claimed in claim 1, wherein the circuitry comprises an application specific integrated circuit (ASIC).

### Claim 10 (depends on 1)

The detector as claimed in claim 1, wherein the circuitry comprises a one-time programmable logic array.

### Claim 11 (depends on 1)

The detector as claimed in claim 1, wherein the circuitry comprises a reprogrammable logic array.

### Claim 12 (depends on 1)

The detector as claimed in claim 1, wherein the circuitry comprises and a digital computer processor with non-transitory computer memory for storing instructions, wherein the digital computer processor is controlled by computer instructions read from the non-transitory computer memory.

### Claim 13 (depends on 1)

The detector as claimed in claim 1, further comprising:
a cap connected to the housing;
a spring system integrated with the cap; and
a switch configured to contact the spring system when the cap is connected to a catheter port, wherein the switch powers on the circuitry when the cap is connected to a catheter port.

### Claim 14 (depends on 1)

The detector as claimed in claim 1, further comprising at least two optical sensors spaced apart, wherein the circuitry for detecting and indicating comprises circuitry configured to determine a direction of movement of the guidewire using the at least two optical sensors.

### Claim 15

A detector for a guidewire to be used with a catheter, comprising:
a housing including a passageway having a first opening on a patient side of the housing and a second opening on a caregiver side of the housing; and
circuitry contained within the housing for detecting and indicating: (1) that the guidewire has not yet entered the housing, (2) that the guidewire has entered the housing, (3) that the guidewire has been removed from a patient through the housing, and (4) determine a distance a first end of the guidewire has progressed past the detector housing having exited the first opening while moving in a direction from the second opening to the first opening.

### Claim 16 (depends on 15)

The detector as claimed in claim 15, wherein the guidewire is marked along its length with color bands or marked with magnetic energized bands, and
wherein the detector further comprises a sensor system configured to determine the distance the guidewire has progressed past the detector housing into the patient.

### Claim 17 (depends on 16)

The detector as claimed in claim 16, wherein at least one of an LCD display, a 7-segment display, and a display is configured to show the distance the guidewire that has progressed past the detector housing into the patient.

### Claim 18

A method of detecting a state of a guidewire being placed into a catheter connected to a detector having a housing including a passageway having a first opening on a patient side of the housing and a second opening on a caregiver side of the housing, the method comprising:
powering on the detector prior to a first end of the guidewire entering the first opening on the patient side by at least one of attaching the detector to the catheter and pushing a power button on the detector;
indicating using the detector that the first end of the guidewire has not yet entered the housing through the first opening on the patient side;
detecting and indicating using the detector that the first end of the guidewire has entered the housing through the first opening on the patient side and a second end of the guidewire has not passed through the second opening on the caregiver side; and
detecting and indicating using the detector that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 19 (depends on 18)

The method as claimed in claim 18, wherein, using at least one LED, the detector indicates (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 20 (depends on 18)

The method as claimed in claim 18, wherein, using at least one speaker, the detector indicates (1) that the first end of the guidewire has not yet entered the housing through the first opening on the patient side, (2) that the first end of the guidewire has entered the housing through the first opening on the patient side and the second end of the guidewire has not passed through the second opening on the caregiver side and (3) that the second end of the guidewire has been removed from the housing through the second opening on the caregiver side having previously entered through the first opening on the patient side.

### Claim 21 (depends on 18)

The method as claimed in claim 18, further comprising:
transmitting, using a light transmitter, light at a selected frequency; and
detecting, using first and second light detectors, (1) that the guidewire is blocking light from the light transmitter from reaching the first light detector and (2) that the guidewire is blocking light from the light transmitter from reaching the second light detector.
