Ultrasound systems and methods for orthopedic applications

• US 8,206,306 B2
• Filed: 11/02/2010
• Issued: 06/26/2012
• Est. Priority Date: 05/07/2009
• Status: Active Grant

• Current Assignee: FUJIFILM Healthcare Corp. (Fujifilm Holdings Corporation)
• Original Assignee: Hitachi Aloka Medical, Ltd (Hitachi, Ltd.)
• Inventors: Baraso, Randall R., Frankel, Bruce M., Tsuchida, Kazutoshi, Wakabayashi, Hiroaki
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US12/917,721
• Publication Number:
  US 20110208062A1
• Time in Patent Office: 602 Days
• Field of Search: 600437-467
• US Class Current: 600/459
• CPC Class Codes: A61B 17/7053 with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• CPC Class Codes: A61B 17/7092 for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2090/0817 Spatulas or spatula like extensions
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0875 for diagnosis of bone A61B5/4504 takes precedence
• 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 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

Medical diagnostic instruments/systems are provided that include (i) a proximal handle configured and dimensioned to permit an operator to manually grasp the instrument; (ii) an ultrasound probe including a longitudinal shaft extending distally from the handle and terminating in a distal end, and an ultrasound transducer mounted with respect to the longitudinal shaft, the ultrasound transducer including an array of ultrasonic energy generation elements (iii) a tactile feeler probe mounted with respect to the ultrasound probe; and (iv) at least one hollow receiver member mounted with respect to the longitudinal shaft of the ultrasound probe, the at least one hollow receiver member configured to receive a K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to a desired anatomical location. Advantageous methods for use of the disclosed instruments/systems are also provided.

Claims

1. A medical diagnostic instrument, comprising:

a proximal handle configured and dimensioned to permit an operator to manually grasp the instrument;

an ultrasound probe including a longitudinal shaft extending distally from the handle and terminating in a distal end, and an ultrasound transducer mounted with respect to the longitudinal shaft, the ultrasound transducer including an array of ultrasonic energy generation elements; and

a tactile feeler probe mounted with respect to the ultrasound probe;

at least one hollow receiver member mounted with respect to the longitudinal shaft of the ultrasound probe;

wherein the ultrasound transducer and the distal end are cooperatively configured, oriented, and dimensioned to permit the operator to insert the ultrasound transducer and the distal end into a desired anatomical location to permit the operator to obtain thereat a corresponding two-dimensional image of the anatomical location for visual inspection by the operator for purposes of detecting ultrasonically-detectable anatomical properties;

wherein the at least one hollow receiver member is configured and dimensioned to receive a K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to the desired anatomical location;

wherein the tactile feeler probe is configured and dimensioned to permit the operator to insert the tactile feeler probe into the desired anatomical location to permit the operator to perform thereat a tactile inspection of the selected anatomical location.

2. The medical diagnostic instrument of claim 1, wherein the tactile feeler probe further Comprises a longitudinal shaft mounted with respect to the longitudinal shaft of the ultrasound probe and extends distally beyond the distal end thereof, and a feeler probe tip defined at a distal end of the longitudinal shaft of the tactile feeler probe;

and

wherein the feeler probe tip and the longitudinal shaft of the tactile feeler probe are cooperatively configured and dimensioned to permit the operator to insert the feeler probe tip and the longitudinal shaft of the tactile feeler probe into the desired anatomical location to permit the operator to perform thereat a tactile inspection of the selected anatomical location.

3. The medical diagnostic instrument of claim 1, wherein the desired anatomical location is a pedicle screw pilot hole formed in the spine of the human patient, and wherein the array of ultrasonic energy generation elements of the ultrasound transducer extends axially along, and is positioned against, a selected portion of a side wall of the pedicle screw pilot hole.

4. The medical diagnostic instrument of claim 2, wherein the longitudinal shaft of the tactile feeler probe defines at least a first longitudinal axis along which the longitudinal shaft of the tactile feeler probe extends distally from the longitudinal shaft of the ultrasound probe, at least a second longitudinal axis along which the longitudinal shaft of the tactile feeler probe extends distally to the feeler probe tip, and a bend formed therebetween such that the first and second longitudinal axes collectively define a first plane.

5. The medical diagnostic instrument of claim 4, wherein the longitudinal shaft of the ultrasound probe defines at least a third longitudinal axis along which the longitudinal shaft of the ultrasound probe extends distally from the handle, wherein the ultrasonic energy generation elements of the array thereof define a fourth longitudinal axis along which the array of ultrasonic energy generation elements extends, wherein the fourth longitudinal axis is radially offset from the third longitudinal axis such that the third and fourth longitudinal axes collectively define a second plane, and wherein the second plane is coplanar with the first plane.

6. The medical diagnostic instrument of claim 5, wherein each of the feeler probe tip and the fourth longitudinal axis is offset from the third longitudinal axis in a common radial direction therefrom such that the feeler probe tip and the array of ultrasonic energy generation elements are rotationally aligned with each other relative to the longitudinal shaft of the ultrasound probe.

7. The medical diagnostic instrument of claim 2, wherein the longitudinal shaft of the ultrasound probe defines a first longitudinal axis along which the longitudinal shaft of the ultrasound probe extends distally from the handle, wherein the ultrasonic energy generation elements of the array thereof define a second longitudinal axis along which the array of ultrasonic energy generation elements extends, wherein the second longitudinal axis is at least partially disposed in radially spaced relation with respect to the first longitudinal axis such that the first and second longitudinal axes collectively define a first plane, and wherein the feeler probe tip is disposed in the first plane.

8. The medical diagnostic instrument of claim 1, wherein the longitudinal shaft of the ultrasound probe defines a first longitudinal axis along which the longitudinal shaft of the ultrasound probe extends distally from the handle, wherein the ultrasonic energy generation elements of the array thereof define a second longitudinal axis along which the array of ultrasonic energy generation elements extends, wherein the second longitudinal axis is radially offset from the first longitudinal axis such that the first and second longitudinal axes define a first plane, wherein the handle includes a longitudinal shaft extending proximally from the ultrasound probe and terminating in a proximal end, the longitudinal shaft of the handle defining a third longitudinal axis along which the handle extends proximally from the ultrasound probe, the third longitudinal axis being disposed in the first plane.

9. The medical diagnostic instrument of claim 1, further comprising at least one channel configured and dimensioned to receive the K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to the desired anatomical location, the channel being one of formed in the handle and extending therethrough, and formed in an extension of the handle and extending therepast.

10. The medical diagnostic instrument of claim 8, wherein the longitudinal shaft of the handle further defines a fourth longitudinal axis disposed in the first plane and along which the longitudinal shaft of the handle extends proximally to the proximal end of the handle, and a bend formed between the third and fourth longitudinal axes such that an angle defined between the fourth and first longitudinal axes is larger than an angle defined between the third and first longitudinal axes, and such that the handle functions as a bayonet handle relative to the ultrasound and feeler probes.

11. The medical diagnostic instrument of claim 1, wherein the handle includes a housing, and wherein the ultrasound probe is mounted with respect to the handle such that the longitudinal shaft of the ultrasound probe is supported, cantilever-style, by the handle housing.

12. The medical diagnostic instrument of claim 2, wherein the tactile feeler probe is mounted with respect to the ultrasound probe such that the longitudinal shaft of the tactile feeler probe is supported, cantilever-style, by the longitudinal shaft of the ultrasound probe.

13. The medical diagnostic instrument of claim 1, wherein the array of ultrasonic, energy generation elements is side-firing and is one of a linear array and a phased array.

14. The medical diagnostic instrument of claim 1, further comprising a cable assembly for carrying electrical signals to and from the ultrasound transducer in accordance with an ultrasonic imaging mode of use of the instrument, the cable assembly including a proximal end including an electrical connector for connecting the instrument to a corresponding ultrasound console and current carrying wires extending distally from the electrical connector to the ultrasound transducer at least partially via a corresponding interior conduit formed in and extending longitudinally along the longitudinal shaft of the ultrasound probe;

and

wherein the handle includes a longitudinal shaft extending proximally from the ultrasound probe and terminating in a proximal end, wherein the current carrying wires extend to the ultrasound transducer through the proximal end of the handle and through a corresponding interior conduit formed in and extending longitudinally along the longitudinal shaft of the handle.

15. The medical diagnostic instrument of claim 1, wherein the array of ultrasonic energy generation elements defines an axial length along the longitudinal shaft of the ultrasound probe of between about 8 millimeters and about 12 millimeters;

and

wherein the tactile feeler probe extending distally beyond the distal end of the longitudinal shaft of the ultrasound probe includes wherein the longitudinal shaft and the feeler probe tip of the tactile feeler probe collectively define an axial length of the tactile feeler probe beyond the array of side-firing ultrasonic energy generation elements of between about 8 millimeters and about 12 millimeters.

16. The medical diagnostic instrument of claim 9, wherein the at least one hollow receiver member is mounted with respect to a distal portion of the longitudinal shaft of the ultrasound probe;

and wherein the channel defines at least a first longitudinal axis and the at least one hollow receiver member defines at least a second longitudinal axis, the first and second longitudinal axes being substantially aligned with one another.

17. The medical diagnostic instrument of claim 1, wherein the at least one hollow receiver member comprises a first hollow receiver member and a second hollow receiver member mounted with respect to the longitudinal shaft of the ultrasound probe, each hollow receiver member configured and dimensioned to receive the K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to the desired anatomical location;

wherein the first hollow receiver member is mounted with respect to a distal portion of the longitudinal shaft of the ultrasound probe and the second hollow receiver member is mounted with respect to a proximal end of the ultrasound probe.

18. The medical diagnostic instrument of claim 17, wherein at least a portion of the second hollow receiver member is mounted with respect to the handle.

19. The medical diagnostic instrument of claim 1, wherein the at least one hollow receiver member extends from a distal portion of the longitudinal shaft of the ultrasound probe to a proximal end of the ultrasound probe.

20. The medical diagnostic instrument of claim 19, wherein at least a portion of the at least one hollow receiver member is mounted with respect to the handle.

21. A medical diagnostic system for use in conjunction with bone tissue, comprising:

a medical diagnostic instrument, the instrument including;

a handle, the handle being disposable proximate an operator of the instrument, the handle being further configured and dimensioned to permit the operator to manually grasp the instrument and manipulate the instrument relative to the spine of a human patient;

an ultrasound probe, the ultrasound probe including a longitudinal shaft extending distally from the handle and terminating in a distal end, and an ultrasound transducer mounted to the longitudinal shaft proximate the distal end thereof, the ultrasound transducer including an array of side-firing ultrasonic energy generation elements extending along the longitudinal shaft, wherein the ultrasound transducer and the distal end are cooperatively configured, oriented, and dimensioned to permit the operator to insert the ultrasound transducer and the distal end into a pedicle screw pilot hole formed in the spine of the human patient such that the array of side-firing ultrasonic energy generation elements of the ultrasound transducer extends axially along, and is positioned against, a selected portion of a side wall of the pedicle screw pilot hole, and to permit the operator to obtain thereat a corresponding two-dimensional image of the selected portion of the side wall for visual inspection by the operator for purposes of detecting ultrasonically-detectable cortical breaches located therein;

a tactile feeler probe mounted with respect to the ultrasound probe, the tactile feeler probe including a longitudinal shaft mounted with respect to the longitudinal shaft of the ultrasound probe and extending distally therefrom beyond the distal end thereof, and a feeler probe tip defined at a distal end of the longitudinal shaft of the tactile feeler probe, the feeler probe tip and the longitudinal shaft of the tactile feeler probe being cooperatively configured and dimensioned to permit the operator to insert the feeler probe tip and the longitudinal shaft of the tactile feeler probe into the pedicle screw pilot hole such that the feeler probe tip is positioned against the selected portion of the side wall of the pedicle screw pilot hole, and to permit the operator to perform thereat a tactile inspection of the selected portion of the side wall of the pedicle screw pilot hole for purposes of detecting manually-detectable cortical breaches located therein;

at least one hollow receiver member mounted with respect to the longitudinal shaft of the ultrasound probe, the at least one hollow receiver member configured and dimensioned to receive a K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to the pedicle screw pilot hole; and

a first cable assembly for carrying electrical signals to and from the ultrasound transducer in accordance with an ultrasonic imaging mode of use of the instrument, the cable assembly including a proximal end including a first electrical connector for connecting the instrument to a corresponding ultrasound console and current carrying wires extending distally from the electrical connector, through the longitudinal shaft of the ultrasound probe and to the ultrasound transducer;

an ultrasound console including a processor for controlling the medical diagnostic instrument, a display for displaying two-dimensional ultrasonic images obtained therefrom by an operator thereof, and a port for receiving a corresponding cable connector; and

a second cable assembly for carrying electrical signals to and from the ultrasound console, the second cable assembly including a second electrical connector coupled to a the port associated with the ultrasound console, a third electrical connector coupled to the first electrical connector, and current carrying wires extending therebetween.

22. A method of exploring a pedicle screw pilot hole formed in the spine of a human patient for cortical breaches located in the axially-extending side-walls thereof, the method including:

presenting a medical diagnostic instrument, the instrument including;

a handle;

an ultrasound probe, the ultrasound probe including a longitudinal shaft extending distally from the handle and terminating in a distal end, and an ultrasound transducer mounted to the longitudinal shaft proximate the distal end thereof, the ultrasound transducer including an array of side-firing ultrasonic energy generation elements extending along the longitudinal shaft;

a tactile feeler probe mounted with respect to the ultrasound probe, the tactile feeler probe including a longitudinal shaft mounted with respect to the longitudinal shaft of the ultrasound probe and extending distally therefrom beyond the distal end thereof, and a feeler probe tip defined at a distal end of the longitudinal shaft of the tactile feeler probe; and

at least one hollow receiver member mounted with respect to the longitudinal shaft of the ultrasound probe, the at least one hollow receiver member configured and dimensioned to receive a K-wire to permit the instrument to be slidably mounted thereto for purposes of guiding the ultrasound and tactile feeler probes axially relative to the pedicle screw pilot hole;

mounting and sliding the medical diagnostic instrument along the K-wire to guide the ultrasound and tactile feeler probes axially relative to the pedicle screw pilot hole during a minimally invasive surgical procedure;

employing the handle to manually grasp and manipulate the medical diagnostic instrument relative to the spine of a human patient, including inserting the ultrasound transducer and the distal end of the longitudinal shaft of the ultrasound probe, and the feeler probe tip and the longitudinal shaft of the tactile feeler probe into a pedicle screw pilot hole formed in the spine of the human patient;

positioning the array of side-firing ultrasonic energy generation elements of the ultrasound transducer relative to a selected portion of a side wall of the pedicle screw pilot hole such that the array of side-firing ultrasonic energy generation elements extends axially along, and is positioned against, the selected portion of a side wall of the pedicle screw pilot hole;

employing the array of side-firing ultrasonic energy generation elements of the ultrasound transducer to obtain a two-dimensional image of the selected portion of the side wall for visual inspection for purposes of detecting ultrasonically-detectable cortical breaches located therein;

positioning the feeler probe tip of the tactile feeler probe relative to the selected portion of the side wall of the pedicle screw pilot hole such that the feeler probe tip is positioned against the side wall of the pedicle screw pilot hole;

employing the feeler probe tip of the tactile feeler probe to perform a tactile inspection of the selected portion of the side wall for purposes of detecting manually-detectable cortical breaches located therein; and

performing the two positioning and the two employing steps without removing any of the ultrasound transducer or the distal end of the longitudinal shaft of the tactile feeler probe or the feeler probe tip of the longitudinal shaft of the tactile feeler probe from the pedicle screw pilot hole.