WO2022133084A1

WO2022133084A1 - Needle guide for ultrasound-guided biopsy

Info

Publication number: WO2022133084A1
Application number: PCT/US2021/063801
Authority: WO
Inventors: Taylor HAMMOND; Enrico MIOZZO; Corey STOCKTON; Jarrett WEIDNER; Shwan AL-KIROWI; Darius BEALE; Armistice DEGUE; Jesse Jenkins; Jason SIZEN; David Sullivan HAINS
Original assignee: The Trustees Of Indiana University
Priority date: 2020-12-17
Filing date: 2021-12-16
Publication date: 2022-06-23

Abstract

An instrument guide comprising a support and an alignment dial. The support is configured to be mounted to an ultrasonic imaging transducer. The alignment dial includes an instrument alignment structure mounted with respect to the support for rotation about a rotational axis. The alignment dial is configured to be rotated to position an instrument supported by the instrument alignment structure at a plurality of angular positions with respect to the support. In embodiments, the alignment dial includes a plurality of instrument alignment structures, such as bores to receive biopsy needles of different sizes, at angularly offset positions with respect to the rotational axis. The guide enables the instruments to be accurately guided to desired locations, including different depths, within the imaged field of view of the transducer.

Description

NEEDLE GUIDE

FOR ULTRASOUND-GUIDED BIOPSY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application is related to U.S. Provisional Patent Application No. 63/127,030, filed December 17, 2020, and U.S. Provisional Patent Application No. 63/151,331, filed February 19, 2021, the entire disclosures of which are incorporated herein by reference.

FIELD

[0002] This disclosure relates generally to instrument guides for use with imaging devices. Embodiments include a biopsy needle guide for use with an ultrasound transducer.

BACKGROUND

[0003] Guides may be used to locate and direct interventional instruments during surgical procedures. For example, the Verza Guidance System available from CIVCO Medical Solutions can be used to guide instruments such as biopsy needles under ultrasonic imaging. There remains, however, a continuing need for improved instrument guides configured for use with imaging devices.

SUMMARY

[0004] Disclosed embodiments include an instrument guide for use with an imaging transducer. The guide and/or transducer can be configured to enable the guide to be releasably mounted to the transducer. The guide enables interventional devices such as, for example, biopsy needles or other elongated instruments, to be accurately guided to desired locations, including different depths, within the imaged field of view of the transducer. Clinicians can thereby conveniently, efficiently and accurately position the interventional device in the patient while viewing images generated through the use of the transducer.

[0005] One example is an instrument guide comprising a support and an alignment member. The alignment member may be mounted for rotation with respect to the support and includes a plurality of instrument alignment structures. Each of the plurality of instrument alignment structures may be configured to receive an instrument having different physical characteristics. The alignment member is rotatable to position each of the plurality of instrument alignment structures at a plurality of angular positions with respect to the support. [0006] In embodiments, the instrument guide further includes a mounting structure for mounting the instrument guide to an imaging device. In any or all of the above embodiments, the mounting structure may be configured to mount the instrument guide to an imaging device transducer. In any or all of the above embodiments the mounting structure may be configured to mount the instrument guide to an ultrasonic imaging device transducer. In any or all of the above embodiments the mounting structure may be configured to mount the support to the imaging device.

[0007] In any or all of the above embodiments the mounting structure may be configured to removably mount the instrument guide to the imaging device. The mounting structure may include a magnet to removably mount the instrument guide to the imaging device.

[0008] In any or all of the above embodiments, the plurality of instrument alignment structures may be configured to receive elongated instruments having different diameters. The alignment member may be configured for rotational movement about a rotational axis within a plane. The instrument alignment structures may be configured to locate the elongated instruments on the alignment member at angularly offset positions with respect to one another about the rotational axis. The instrument alignment structures may be configured to locate the elongated instruments within the plane of the alignment member, and optionally within a common plane. In any or all of the above embodiments, the instrument alignment structures may include bores having different diameters.

[0009] In any or all of the above embodiments, the alignment member may be a diskshaped member. In any or all of the above embodiments, the alignment member may include instrument location indicia representative of locations of the instruments received by the plurality of instrument alignment structures. The instrument location indicia may define linear paths.

[0010] In any or all of the above embodiments, the support may include angle indicia representative of one or more of the plurality of angular positions.

[0011] Any or all of the above embodiments may further comprise a bracket, wherein the bracket is configured to releasably mount to the imaging device and to releasably receive the instrument guide.

[0012] Another example is an instrument guide, comprising a support configured to be mounted to an ultrasonic imaging transducer, and an alignment dial including an instrument alignment structure mounted with respect to the support for rotation about a rotational axis. The alignment dial is configured to be rotated to position an instrument supported by the instrument alignment structure at a plurality of angular positions with respect to the support.

[0013] In embodiments, the support includes a plurality of angle position indicia, and the alignment dial is configured to be rotated to position the instrument supported by the instrument alignment structure at the angular positions represented by the plurality of angle position indicia. In embodiments, the alignment dial includes a plurality of instrument alignment structures, wherein the plurality of alignment structures are configured to receive differently sized instruments at angularly offset positions with respect to the rotational axis. The instrument alignment structures include bores in embodiments.

[0014] Another example is a method for using an instrument guide mounted to an ultrasonic imaging transducer. The method may comprise rotating a dial of the instrument guide to position an instrument alignment structure of the dial at a desired angle, and inserting an instrument, optionally a biopsy needle, into the instrument alignment structure. In embodiments, the dial includes a plurality of instrument alignment structures, each for receiving a differently sized instrument. Rotating the dial may include rotating the dial to position a selected one of the plurality of instrument alignment structures at the desired angle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is an isometric illustration of an instrument guide mounted to an imaging system transducer handle, in accordance with embodiments.

[0016] FIG. 2 is an illustration of an exemplary imaging system with which embodiments of the instrument guide may be used.

[0017] FIG. 3 is an exploded isometric view of components of the instrument guide, and a bracket and attachment structure, in accordance with embodiments.

[0018] FIG. 4 is an isometric illustration of a dial of the instrument guide, in accordance with embodiments.

[0019] FIG. 5 is an isometric illustration of embodiments of a dial of the instrument guide, showing a side opposite the side shown in FIG. 4, in accordance with embodiments.

[0020] FIG. 6 is an isometric illustration of a support of the instrument guide, in accordance with embodiments.

DETAILED DESCRIPTION [0021] FIG. 1 is an isometric illustration of an instrument guide 10 in accordance with embodiments mounted to a transducer handle 12 of an imaging system. The illustrated embodiments of the instrument guide 10 include a support 14 and an alignment member such as dial 16 rotatably mounted to the support. Instrument guide 10 is mounted to a bracket 18 on the handle 12 by an attachment structure 20 in the illustrated embodiments. As described in greater detail below, instrument guide 10 can be used by clinicians during imaging procedures to accurately guide and place instruments 22 in patients.

[0022] FIG. 2 illustrates an ultrasonic imaging system 30 as an example of a type of imaging system with which the instrument guide 10 may be used. Ultrasonic imaging system 30 includes an ultrasonic transducer and sensor (not visible in FIG. 2) at an end 33 of the handle 12, and an imaging device 34. The transducer and sensor are coupled to the imaging device 34, for example by cable 35 is the illustrated embodiment. Ultrasonic imaging systems such as 30 are generally known and commercially available, for example, from Butterfly Network, Inc. In response to ultrasonic signals applied to a target area in the patient to be imaged, reflected ultrasonic signals received by the sensor are processed by the imaging device 34 to generate a visual display 36 of the imaged field of view. The use of instrument guide 10 with other types of imaging systems.

[0023] Embodiments of instrument guide 10 can be described in greater detail with reference to FIGs. 1 and 3-6. Dial 16 is configured for rotation about a rotational axis 40, and includes a disk-shaped portion 42 in the illustrated embodiment. One or more bores 44A-44C extend though the dial 16. Although three bores 44A-44C are shown in the illustrated embodiments, other embodiments may have fewer or greater numbers of bores. In the illustrated embodiments, the bores 44A-44C extend through the rotational axis 40 and are angularly spaced apart or offset from one another. The bores 44A-44C are generally perpendicular to the rotational axis 40, and are generally coplanar to one other in the illustrated embodiments. The bores 44A-44C function as instrument alignment structures for releasably receiving and guiding elongated instruments such as 22. Two or more of the bores 44A-44C can be configured to receive and guide instruments having different sizes or other physical characteristics. In the illustrated embodiments, for example, each of the bores 44A-44C has a different diameter so as to be configured to receive and guide instruments having different gauge diameters (e.g., fourteen, sixteen and eighteen mm diameter instruments). Examples of instruments 22 that can be received and guided by the bores 44A-44C include, for example, biopsy devices, aspiration devices, ablation devices and medication delivery devices. The illustrated embodiments of dial 16 also include instrument location indicia 46 defining lines corresponding to the locations of the bores 44A-44C to provide visual representations of the locations of instruments 22 received by the bores. Other embodiments of dial 16 include other instrument alignment structures, such as for example recesses or indicia, for receiving and/or guiding the instruments 22.

[0024] Support 14 positions and supports the dial 16 for rotation about its rotational axis 40, while providing access to the bores 44A-44C at a plurality of angular positions, or angles, with respect to the support. In the illustrated embodiment the support 14 is a shell-shaped structure 15 having a first or front member 50 and a second or back member 52 spaced apart from one another by a first side member 54 and a second side member 56. The structure 15 of the support 14 defines an opening 58 on a first or upper side and an opening 60 on the second or lower side, enabling instruments 22 be inserted into the dial 16 and through the instrument guide 10. Dial 16 can be inserted into the shell-shaped structure 15 though the opening 60 in the lower side, and retained within the structure 15 by a retainer 62 having a pair of legs 64 that support the opposite edges of the dial. The illustrated embodiments include an opening 66 through the first side member 54 to enable visualization of the instrument location indicia 46 during use of the instrument guide 10. A plurality of angular position indicia 68 are located on the support 14 to provide visual indications of a plurality of different angular locations of the dial 16 about its rotational range within the support 14.

[0025] Bracket 18 is a two-piece member in the illustrated embodiments, and includes first member 70 defining an opening region 72 and a second member 74 defining an opening region 76. Members 70 and 74 mate with one another and engage the transducer handle 12 with the handle extending through the opening defined by the opening regions 72 and 74. Components of an engagement structure 78 such as for example a releasable a spring clip can releasably couple the members 70 and 74 to secure them to the transducer handle 12. Other embodiments (not shown) include other structures for bracket 18, such as for example a belt with a buckle or an elastic band. Yet other embodiments (not shown) include a mounting structure that provides the functionality of the bracket as a member formed on the handle.

[0026] Instrument guide 10 is mounted to the bracket 18 by a mounting structure 20. In embodiments, the mounting structure 20 enables the instrument guide 10 to be releasably mounted to the bracket 18. In embodiments, the mounting structure 20 includes one or more magnets or other elements having suitable magnetic properties (e.g., ferro magnetic material that is attracted to magnets) that cooperate with complementary magnets or other elements having magnetic properties on the bracket 18. For example, the mounting structure 20 can comprise one or more magnets mounted to the side member 54 of the instrument guide that releasably couple to ferromagnetic elements or magnets in the bracket 18. Other embodiments include other structures, such as for example mechanical latches, to releasably couple the instrument guide 10 to the transducer handle 12.

[0027] The instrument guide 10, bracket 18 and attachment structure 20 are configured in such a manner that when instruments 22 are inserted into the bores 44A-44C, they will be guided to areas within the patient being imaged by the imaging system (e.g., within the imaged field of view). For example, instrument guide 10 can guide the instruments to imaged field of view areas directly below the end of the transducer handle 12. In the illustrated embodiments, for example, the instrument guide is mounted with respect to the transducer handle 12 (e.g., by the attachment structure), in such a manner that during rotation of the dial 16, the bores 44A-44C cause the instruments 22 to move about a plane that is within or intersects the imaged field of view of the transducer (e.g., directly below the transducer). In the illustrated embodiments, for example, the plane that the dial 16 rotates in intersects the area under the transducer handle 12 that is imaged by the transducer during use of the imaging system. The instruments 22, and the locations of the instruments with respect to regions within the imaged field of view, can thereby be visualized by use of the imaging system 30.

[0028] A clinician can use the instrument guide 10 with instruments having different sizes. The clinician may, for example select one of the bores 44A-44C that corresponds to the size of the instrument being used in a procedure. Accurate positioning of the instruments 22 may be enhanced by selecting and using a bore 44A-44C corresponding in size to the instrument.

[0029] Positioning of the instruments 22 may also be enhanced by rotating the dial 16 to position the opening of the selected bore 44A-44C at a desired angle or angular position with respect to the support 14 (e.g., as indicated by angular position indicia 68.) The selected angular position may depend on the depth that the instrument is being inserted into the patient during the procedure. By selecting an appropriate angular position based on a desired depth of the instrument placement, the clinician can use the instrument guide 10 to accurately guide the instrument to the desired tissue location within the patient, while the instrument is within the imaged field of view. When the dial 16 has been rotated to position the selected bore 44A-44C at the selected angular position, the instrument 22 can be inserted through the bore and dial to accurately locate and position the instrument for the procedure.

[0030] Instrument guide 10 provides a number of important advantages in addition to its ability to assist clinicians in the accurate placement of a range of differently sized instruments in connection with procedures performed under imaging. The guide may provide these functions without breaking sterile sleeves outside the transducer handle 12. The bracket 18 provides a tight fit to the outer contour of the transducer handle 12. Multiple instrument lengths are supported. It enables linear vision to provide visualization from multiple angles. It can be relatively easily disassembled from the transducer handle, and components may be sterilized for reuse.

[0031] It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. It is contemplated that features described in association with one embodiment are optionally employed in addition or as an alternative to features described in or associated with another embodiment. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. An instrument guide, comprising: a support; an alignment member mounted for rotation with respect to the support and including a plurality of instrument alignment structures, wherein: each of the plurality of instrument alignment structures is configured to receive an instrument having different physical characteristics; and the alignment member is rotatable to position each of the plurality of instrument alignment structures at a plurality of angular positions with respect to the support.

2. The instrument guide of claim 1 and further including a mounting structure for mounting the instrument guide to an imaging device.

3. The instrument guide of claim 2 wherein the mounting structure is configured to mount the instrument guide to an imaging device transducer.

4. The instrument guide of claim 3 wherein the mounting structure is configured to mount the instrument guide to an ultrasonic imaging device transducer.

5. The instrument guide of claim 2 wherein the mounting structure is configured to mount the support to the imaging device.

6. The instrument guide of claim 2 wherein the mounting structure is configured to removably mount the instrument guide to the imaging device.

7. The instrument guide of claim 6 wherein the mounting structure includes a magnet to removably mount the instrument guide to the imaging device.

8. The instrument guide of claim 1 wherein the plurality of instrument alignment structures are configured to receive elongated instruments having different diameters.

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9. The instrument guide of claim 8 wherein: the alignment member is configured for rotational movement about a rotational axis within a plane; and the instrument alignment structures are configured to locate the elongated instruments on the alignment member at angularly offset positions with respect to one another about the rotational axis.

10 The instrument guide of claim 9 wherein the instrument alignment structures are configured to locate the elongated instruments within the plane of the alignment member, and optionally within a common plane.

11. The instrument guide of claim 10 wherein the instrument alignment structures include bores having different diameters.

12. The instrument guide of claim 11 wherein the alignment member is a disk-shaped member.

13. The instrument guide of claim 1 wherein the alignment member includes instrument location indicia representative of locations of the instruments received by the plurality of instrument alignment structures.

14. The instrument guide of claim 13 wherein the instrument location indicia define linear paths.

15. The instrument guide of claim 1 wherein the support includes angle indicia representative of one or more of the plurality of angular positions.

16. The instrument guide of claim 1 and further comprising a bracket, wherein the bracket is configured to releasably mount to the imaging device and to releasably receive the instrument guide.

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17. The instrument guide of claim 1 wherein the instrument guide is configured to locate the instruments within an imaged field of view of the instrument.

18. The instrument guide of claim 17 wherein the alignment member is rotatable in a plane that intersects with the imaged field of view of the instrument.

19. An instrument guide, comprising: a support configured to be mounted to an ultrasonic imaging transducer; and an alignment dial including an instrument alignment structure mounted with respect to the support for rotation about a rotational axis, wherein the alignment dial is configured to be rotated to position an instrument supported by the instrument alignment structure at a plurality of angular positions with respect to the support.

20. The instrument guide of claim 19 wherein: the support includes a plurality of angle position indicia; and the alignment dial is configured to be rotated to position the instrument supported by the instrument alignment structure at the angular positions represented by the plurality of angle position indicia.

21. The instrument guide of claim 20 wherein the alignment dial includes a plurality of instrument alignment structures, wherein the plurality of alignment structures are configured to receive differently sized instruments at angularly offset positions with respect to the rotational axis.

22. The instrument guide of claim 21 wherein the instrument alignment structures are bores.

23. The instrument guide of claim 22 wherein the instrument guide is configured to locate the instruments within an imaged field of view of the instrument.

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24. The instrument guide of claim 23 wherein the alignment member is rotatable in a plane that intersects with the imaged field of view of the instrument.

25. A method for using an instrument guide mounted to an ultrasonic imaging transducer, comprising: rotating a dial of the instrument guide to position an instrument alignment structure of the dial at a desired angle; and inserting an instrument, optionally a biopsy needle, into the instrument alignment structure.

26. The method of claim 25 wherein: the dial includes a plurality of instrument alignment structures, each for receiving a differently sized instrument; and rotating the dial includes rotating the dial to position a selected one of the plurality of instrument alignment structures at the desired angle.

27. The method of any of claim 25 wherein: rotating the dial includes rotating the dial in a plane that intersects an imaged field of view of the imaging transducer; and inserting the instrument includes inserting the instrument into the imaged field of view of the imaging transducer.

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