# US 11,998,237 B2 · Intraosseous device including a sensing obturator

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- Number: US 11,998,237 B2
- Document ID: US11998237B2
- Status: Granted
- Kind: B2
- Application number: 17/337,100
- Filed: 2021-06-02
- Published: 2021-12-09
- Granted: 2024-06-04
- Earliest claimed: 2020-06-03
- Assignees: Bard Access Systems, Inc.
- Applicants: Bard Access Systems, Inc.
- Inventors: Eric W. Lindekugel; Daniel Pett
- Web page: https://patentgrep.com/patent/US11998237B2

## CPC

- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/1622: {Drill handpieces (A61B17/1626, A61B17/1628 take precedence)}
- A61B 17/1626: {Control means; Display units}
- A61B 90/98: using electromagnetic means, e.g. transponders
- A61B 17/3496: {Protecting sleeves or inner probes; Retractable tips (for protecting body piercing guide needles A61M25/0612)}
- A61B 2017/00026: {Conductivity or impedance, e.g. of tissue}
- A61B 2017/00035: {pH}
- A61B 2017/00084: {Temperature}
- A61B 2017/00123: {and automatic shutdown}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed herein are medical device systems, and methods thereof, for automatically detecting access to a medullary cavity. Embodiments include intraosseous access systems with sensing obturators, configured to detect a change in modality, e.g. pressure, oxygen saturation, electrical impedance, etc. at a distal tip thereof. Signals can be transmitted to a control logic that can modify the activation of a driver in response. Signals can be transmitted by way of wired or wireless communication. In an embodiment, signals can be transmitted through conductive polymer material that forms the obturator and allows the obturator to be flexible enough to mitigate accidental needle stick injuries.

## Claims

### Claim 1

An obturator assembly configured for use with an intraosseous access system, comprising:
an elongate obturator body; and
an electrical impedance sensor disposed proximate a distal end of the obturator body, the electrical impedance sensor configured to detect a change in modality to determine access to a medullary cavity, the electrical impedance sensor communicatively coupled with a control logic disposed in a driver of the intraosseous access system, the control logic configured to modify operation of the driver when the electrical impedance sensor detects the change in modality, the electrical impedance sensor further including an RFID chip, wherein the change in modality detected by the electrical impedance sensor transitions the RFID chip from an inactive state to an active state and, wherein the control logic is configured to provide an interrogation signal configured to induce a response signal from the RFID chip in the active state to determine access to the medullary cavity.

### Claim 2 (depends on 1)

The obturator assembly according to claim 1, wherein the obturator body further includes a sensor interface disposed at a proximal end of a hub of the obturator body, the sensor interface configured to both rotatably and communicatively couple the electrical impedance sensor with the control logic.

### Claim 3 (depends on 2)

The obturator assembly according to claim 2, wherein the obturator body includes one of an electrically conductive or an optically conductive thermoplastic configured to communicatively couple the electrical impedance sensor with the sensor interface.

### Claim 4 (depends on 2)

The obturator assembly according to claim 2, wherein the obturator body includes a wire extending axially therethrough to communicatively couple the electrical impedance sensor with the sensor interface.

### Claim 5 (depends on 1)

The obturator assembly according to claim 1, wherein the obturator body is configured to be disposed within a needle, and wherein the electrical impedance sensor is disposed proximate a distal end of the needle.

### Claim 6 (depends on 1)

The obturator assembly according to claim 1, wherein the obturator body further includes a second sensor configured to detect a second modality configured to determine access to the medullary cavity.

### Claim 7 (depends on 6)

The obturator assembly according to claim 6, wherein the second sensor is selected from a group consisting of a pressure transducer, an oxygen saturation sensor, a temperature sensor, and a pH sensor.

### Claim 8

A method of detecting access to a medullary cavity, comprising:
providing an elongate obturator body including an electrical impedance sensor disposed at a distal end of the obturator body;
urging the elongate obturator body through a bone cortex;
detecting a first electrical impedance modality level;
accessing the medullary cavity;
detecting a change in modality level from the first electrical impedance modality level to determine access to the medullary cavity; and
communicating the change in modality level to a control logic, wherein the electrical impedance sensor further includes an RFID chip configured to transition between an active state and an inactive state, and wherein detecting the change in modality level transitions the RFID chip to the active state and, wherein, the control logic provides an interrogation signal configured to induce a response signal from the RFID chip in the active state and determines access to the medullary cavity.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the elongate obturator body is disposed within an intraosseous access needle.

### Claim 10 (depends on 8)

The method according to claim 8, wherein the control logic is disposed within an intraosseous access driver releasably coupled to the elongate obturator body.

### Claim 11 (depends on 10)

The method according to claim 10, further including modifying an operation of the intraosseous access driver by the control logic when the electrical impedance sensor detects the change in modality level.

### Claim 12 (depends on 10)

The method according to claim 10, wherein the obturator body further includes a sensor interface disposed at a proximal end thereof and configured to engage the intraosseous access driver and communicatively and rotatably couple the electrical impedance sensor and the control logic.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the obturator body includes an electrically conductive thermoplastic configured to communicatively couple the electrical impedance sensor with the sensor interface.

### Claim 14 (depends on 12)

The method according to claim 12, wherein the obturator body includes a wire extending axially therethrough and configured to communicatively couple the electrical impedance sensor with the sensor interface.

### Claim 15 (depends on 8)

The method according to claim 8, further including detecting a change in a second modality level to determine access to the medullary cavity and communicating the change in the second modality level to the control logic.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the second modality level is selected from a group consisting of a pressure, an oxygen saturation, a temperature and a pH.