Ultrasound stylet

• US 10,123,766 B2
• Filed: 12/10/2012
• Issued: 11/13/2018
• Est. Priority Date: 12/08/2011
• Status: Active Grant

• Current Assignee: University Of Washington Through Its Center For Commercialization
• Original Assignee: University of Washington
• Inventors: Mourad, Pierre D., Browd, Samuel R., MacConaghy, Brian, Murthy, Revathi, Coulson, Nathaniel
• Primary Examiner(s): Peng, Bo J
• Application Number:
  US14/359,075
• Publication Number:
  US 20140323857A1
• Time in Patent Office: 2,164 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0858 involving measuring tissue layers, e.g. skin, interfaces
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/4494 characterised by the arrangement of the transducer elements devices for short-range imaging using particular transducer elements arrangements under G01S15/8909; arrangements of transducers in generation of mechanical vibrations of infrasonic, sonic or ultrasonic frequency B06B1/0607
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/462 characterised by constructional features of the display
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/5207 involving processing of raw data to produce diagnostic data, e.g. for generating an image reconstruction G06T11/00
• CPC Class Codes: A61B 8/54 Control of the diagnostic device
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A stylet (100) includes a handle assembly (102) with an indicator display (112) and a stiff wire assembly (120) extending distally from the handle assembly (102) having a non-imaging ultrasonic device on a distal end. The stylet includes a circuit assembly having one or more of a pulser (120), a transmit/receive chip (132), a bandpass filter (134), a differential amplifier (136), an ADC (138), and an MCU (140), operable to control the operation of the ultrasonic device and to receive and analyze data from the ultrasonic device to facilitate implantation of a device such as a catheter.

Claims

1. A stylet for use in medical procedures, comprising:

an elongate member comprising a stiff wire tubular assembly configured to receive a catheter and configured for placing the catheter into a tissue;

an indicator configured to selectively activate a first status prompt to indicate a desired alignment of the elongate member;

wherein the stiff wire tubular assembly further comprises a non-imaging ultrasonic device fixed to a distal end of the elongate member, and further wherein the non-imaging ultrasonic device is configured to selectively generate ultrasonic waves in a direction longitudinally aligned with the elongate member, and to detect scattered ultrasonic waves;

a microprocessor operably connected to the non-imaging ultrasonic device and configured to control the selective generation of ultrasonic waves, and to process the detected scattered ultrasonic waves to detect an internal tissue-fluid boundary;

wherein the microprocessor is operably connected to the indicator, and the microprocessor causes the indicator to activate the first status prompt when the internal tissue-fluid boundary is detected, indicating the elongate member is aligned with the detected internal tissue-fluid boundary, prior to placing the catheter into the tissue.

2. The stylet of claim 1, wherein the indicator is attached to a proximal end of the elongate member.

3. The stylet of claim 1, wherein the indicator is configured to selectively activate a second status prompt indicating a non-desired alignment of the elongate member.

4. The stylet of claim 3, wherein the second status prompt includes a marking to indicate a direction to pivot the stylet toward the desired alignment.

5. The stylet of claim 1, wherein the first status prompt also indicates a distance to the internal tissue-fluid boundary.

6. The stylet of claim 1, wherein the elongate member comprises a rigid elongate member, a flexible elongate member, a guidewire, a cannula, a needle, a curved elongate member, or a straight elongate member.

7. The stylet of claim 1, wherein the non-imaging ultrasonic device comprises a single ultrasonic transducer that is configured to selectively operate in a transmit mode, wherein the ultrasonic transducer generates ultrasonic waves, and in a receive mode, wherein the ultrasonic transducer detects ultrasonic waves.

8. The stylet of claim 1, wherein the ultrasonic device comprises a plurality of ultrasonic transducers comprising fewer than ten transducers.

9. The stylet of claim 8, wherein the plurality of ultrasonic transducers are disposed in an array wherein, a distal face of all of the transducers are coplanar.

10. The stylet of claim 8, wherein the plurality of ultrasonic transducers are formed from a single crystal.

11. The stylet of claim 1, further comprising a pulser, a transmit/receive chip, a bandpass filter, and an analog-to-digital converter mounted with the microprocessor to form a circuit assembly that is operable to control the operation of the ultrasonic device and to analyze the detected ultrasonic waves.

12. The stylet of claim 11, further comprising a cable that extends from the ultrasonic device, through the elongate member, and to the circuit assembly to operably connect the ultrasonic device with the circuit assembly.

13. The stylet of claim 11, further comprising a handle formed as an enclosure that houses the indicator and fixedly attaches to the elongate member.

14. The stylet of claim 13, wherein the handle encloses the circuit assembly and further comprises a power supply operably connected to the circuit assembly.

15. The stylet of claim 1, further comprising an external control unit that houses the microprocessor and further comprises a pulser, a transmit/receive chip, a bandpass filter, and an analog-to-digital converter mounted with the microprocessor to form a circuit assembly that is operable to control the operation of the ultrasonic device and to analyze the detected ultrasonic waves, wherein the circuit assembly is operably and releasably connected to the indicator and to the ultrasonic device.

16. The stylet of claim 1, further comprising an elongate catheter configured to slidably receive the elongate member and the ultrasonic device.

17. The stylet of claim 16, wherein the catheter further has a distal end that is either open or is closed with an acoustic lens.

18. The stylet of claim 1, wherein the indicator is disposed directly over a proximal end of the elongate member and is oriented perpendicular to the elongate member.

19. The stylet of claim 1, wherein the indicator comprises a display that is configured to selectively display the first status prompt.

20. The stylet of claim 1, wherein the indicator comprises a display that is configured to selectively indicate the thickness of the internal tissue-fluid boundary.

21. The stylet of claim 1, wherein the indicator is configured to selectively generate an audible prompt to indicate the desired alignment.

22. The stylet of claim 1, wherein the indicator is configured to selectively generate a haptic prompt to indicate the desired alignment.

23. The stylet of claim 1, wherein the microprocessor and the indicator are in wireless communication.