Granted Patent B2

US 12,575,734 · App. 17/793,144 · Granted Mar 17, 2026

Inventors: Ehud J. Schmidt (Towson, MD); Yue Chen (Boston, MA); Akila Viswanathan (Baltimore, MD); Henry R. Halperin (Baltimore, MD); Junichi Tokuda (Boston, MA); Anthony Gunderman (Fayetteville, AR)

Assignee: THE JOHNS HOPKINS UNIVERSITY

A61B5/0036A61B5/055A61B34/20G01R33/287G01R33/34A61B5/062A61B2017/00323A61B2017/00911A61B2017/3411A61B2034/2051A61B2090/374A61B2090/3958A61N5/1001A61N5/1007A61N2005/1012A61N5/1027

Abstract

Claims (66)

1 . A magnetic resonance imaging (MRI) compatible tissue analysis device, comprising:

at least one sheath comprising at least one channel disposed at least partially therethrough;

at least one elongated probe at least partially disposed and selectively movable within the channel of the sheath, which elongated probe is insertable into at least one tissue, wherein the elongated probe comprises an outer diameter of about 2.2, millimeters or less and wherein one or more grooves each having a substantially flat surface are disposed in the elongated probe, which grooves comprise a depth of about 0.25 millimeters or more;

at least one multilayer radio-frequency (RF) tracking element operably connected to the substantially flat surface of at least one of the grooves of the elongated probe, which RF tracking element is operably connected, or connectable, to at least one MRI apparatus that is configured to track positioning of the elongated probe in substantially real-time at least when the elongated probe is inserted into the tissue and wherein the RF tracking element comprises a thickness of about 0.25 millimeters or less such that the RF tracking element does not extend beyond an outer surface of the elongated probe;

at least one multilayer RF imaging element operably connected to the elongated probe or to the sheath, which RF imaging element is operably connected, or connectable, to the MRI apparatus that is further configured to capture one or more images of the elongated probe and/or the tissue in substantially real-time at least when the elongated probe is inserted into the tissue and wherein the RF imaging element comprises a thickness of about 0.25 millimeters or less;

at least one deflection mechanism operably connected at least to the elongated probe, which deflection mechanism is configured to selectively deflect positioning of at least a portion of the elongated probe; and,

at least one handle operably connected at least to the elongated probe and/or to the sheath,

wherein the sheath is configured to remain substantially statically straight regardless of a dynamic tension applied by the deflection mechanism,

wherein the elongated probe comprises at least one cavity that is disposed substantially through a length of the elongated probe, wherein at least one co-axial cable is at least partially disposed within the cavity and operably connected to the RF tracking element and/or the RF imaging element and operably connected, or connectable, to the MRI apparatus,

wherein the deflection mechanism comprises at least one tendon operably connected at least proximal to an end of the elongated probe that is insertable into the tissue and to a tension adjustment element operably connected to the handle, which tendon is at least partially disposed within the cavity and which tension adjustment element is configured to selectively effect deflection of the positioning of the portion of the elongated probe,

wherein the elongated probe comprises at least one deflectable region that deflects when the deflection mechanism selectively deflects positioning of the portion of the elongated probe,

wherein the deflectable region comprises multiple orifices disposed at least partially through the elongated probe, which orifices communicate with the cavity,

wherein at least one of the orifices comprises at least one indentation disposed substantially perpendicular to a longitudinal axis of the elongated probe, and

wherein the MRI compatible tissue analysis device produces an effective field of view of at least about 30 mm×14 mm×14 mm when the MRI compatible tissue analysis device is operably connected to the MRI apparatus.

2 . The device of claim 1 , wherein the RF imaging element is operably connected to the substantially flat surface of at least one of the grooves of the elongated probe.

3 . The device of claim 1 , wherein the RF tracking element comprises at least one antenna tuned, or tunable, to a magnetic resonance (MR) frequency.

4 . The device of claim 1 , wherein the deflection mechanism is configured to selectively deflect positioning of at least a tip of the elongated probe.

5 . The device of claim 1 , comprising at least one collet adapter operably connected to the handle and at least one collect nut adjustably engaged with the collet adapter, which collet adapter and collet nut are configured to adjustably limit radial and/or axial displacement of the elongated probe and/or the sheath relative to the handle.

6 . The device of claim 1 , comprising at least a portion of at least one axial rotational control mechanism operably connected, or connectable, to the device.

7 . A system, comprising

at least one magnetic resonance imaging (MRI) compatible tissue analysis device, comprising:

at least one sheath comprising at least one channel disposed at least partially therethrough;

at least one elongated probe at least partially disposed and selectively movable within the channel of the sheath, which elongated probe is insertable into at least one tissue, wherein the elongated probe comprises an outer diameter of about 2.2, millimeters or less and wherein one or more grooves each having a substantially flat surface are disposed in the elongated probe, which grooves comprise a depth of about 0.25 millimeters or more;

at least one multilayer radio-frequency (RF) tracking element operably connected to the substantially flat surface of at least one of the grooves of the elongated probe, wherein the RF tracking element comprises a thickness of about 0.25 millimeters or less such that the RF tracking element does not extend beyond an outer surface of the elongated probe;

at least one multilayer RF imaging element operably connected to the elongated probe or to the sheath, wherein the RF imaging element comprises a thickness of about 0.25 millimeters or less;

at least one deflection mechanism operably connected at least to the elongated probe, which deflection mechanism is configured to selectively deflect positioning of the elongated probe;

at least one handle operably connected at least to the elongated probe and/or to the sheath; and

at least one signal amplification mechanism operably connected, or connectable, to the RF tracking element and to the RF imaging element, which signal amplification mechanism is configured to amplify one or more signals received from the RF tracking element and/or from the RF imaging element;

wherein the sheath is configured to remain substantially statically straight regardless of a dynamic tension applied by the deflection mechanism,

wherein the elongated probe comprises at least one cavity that is disposed substantially through a length of the elongated probe, wherein at least one co-axial cable is at least partially disposed within the cavity and operably connected to the RF tracking element and/or the RF imaging element and operably connected, or connectable, to the MRI apparatus,

wherein the deflection mechanism comprises at least one tendon operably connected at least proximal to an end of the elongated probe that is insertable into the tissue and to a tension adjustment element operably connected to the handle, which tendon is at least partially disposed within the cavity and which tension adjustment element is configured to selectively effect deflection of the positioning of the portion of the elongated probe,

wherein the elongated probe comprises at least one deflectable region that deflects when the deflection mechanism selectively deflects positioning of the portion of the elongated probe,

wherein the deflectable region comprises multiple orifices disposed at least partially through the elongated probe, which orifices communicate with the cavity,

wherein at least one of the orifices comprises at least one indentation disposed substantially perpendicular to a longitudinal axis of the elongated probe; and

wherein the MRI compatible tissue analysis device produces an effective field of view of at least about 30 mm×14 mm×14 mm when the MRI compatible tissue analysis device is operably connected to an MRI apparatus; and,

at least one MRI apparatus operably connected, or connectable, to the RF tracking element and to the RF imaging element, which MRI apparatus comprises at least one controller that comprises, or is capable of accessing, computer readable media comprising non-transitory computer-executable instructions which, when executed by at least one electronic processor perform at least:

tracking one or more positions of the elongated probe in substantially real-time at least when the elongated probe is inserted into the tissue, and

capturing one or more images of the elongated probe and/or the tissue in substantially real-time at least when the elongated probe is inserted into the tissue.

8 . The system of claim 7 , wherein the signal amplification mechanism is configured to measure the signals before and after being amplified.

9 . The system claim 7 , wherein the signal amplification mechanism is operably connected to a power source.

10 . The system of claim 7 , wherein the signal amplification mechanism is operably connected, or connectable, to the RF tracking element and to the RF imaging element via at least one selectively connectable cable that comprises at least one operably connected Balun.

11 . The system of claim 7 , wherein the signal amplification mechanism is operably connected, or connectable, to the MRI apparatus via at least one cable that comprises at least one operably connected Balun.

12 . The system of claim 7 , wherein the RF imaging element is operably connected to the substantially flat surface of at least one of the grooves of the elongated probe.

13 . The system of claim 7 , wherein a system box houses the signal amplification mechanism.

14 . A method of analyzing tissue, the method comprising:

positioning a magnetic resonance imaging (MRI) compatible tissue analysis device substantially proximal to at least one tissue, wherein the MRI compatible tissue analysis device produces an effective field of view of at least about 30 mm×14 mm×14 mm when the MRI compatible tissue analysis device is operably connected to at least one MRI apparatus, which tissue analysis device comprises:

at least one sheath comprising at least one channel disposed at least partially therethrough;

at least one elongated probe at least partially disposed and selectively movable within the channel of the sheath, wherein the elongated probe comprises an outer diameter of about 2.2, millimeters or less and wherein one or more grooves each having a substantially flat surface are disposed in the elongated probe, which grooves comprise a depth of about 0.25 millimeters or more;

at least one multilayer RF tracking element operably connected to the substantially flat surface of at least one of the grooves of the elongated probe, wherein the RF tracking element comprises a thickness of about 0.25 millimeters or less such that the RF tracking element does not extend beyond an outer surface of the elongated probe, which RF tracking element is operably connected to the MRI apparatus;

at least one multilayer RF imaging element operably connected to the elongated probe and/or the sheath, wherein the RF imaging element comprises a thickness of about 0.25 millimeters or less, which RF imaging element is operably connected to the MRI apparatus;

at least one deflection mechanism operably connected at least to the elongated probe; and

at least one handle operably connected at least to the elongated probe and/or to the sheath;

inserting at least a portion of the elongated probe into the tissue;

wherein the sheath is configured to remain substantially statically straight regardless of a dynamic tension applied by the deflection mechanism,

wherein the elongated probe comprises at least one cavity that is disposed substantially through a length of the elongated probe, wherein at least one co-axial cable is at least partially disposed within the cavity and operably connected to the RF tracking element and/or the RF imaging element and operably connected, or connectable, to the MRI apparatus,

wherein the deflection mechanism comprises at least one tendon operably connected at least proximal to an end of the elongated probe that is insertable into the tissue and to a tension adjustment element operably connected to the handle, which tendon is at least partially disposed within the cavity and which tension adjustment element is configured to selectively effect deflection of the positioning of the portion of the elongated probe,

wherein the elongated probe comprises at least one deflectable region that deflects when the deflection mechanism selectively deflects positioning of the portion of the elongated probe,

wherein the deflectable region comprises multiple orifices disposed at least partially through the elongated probe, which orifices communicate with the cavity, and

wherein at least one of the orifices comprises at least one indentation disposed substantially perpendicular to a longitudinal axis of the elongated probe; and,

tracking one or more positions of the elongated probe in substantially real-time using at least the RF tracking element and the MRI apparatus; and,

capturing one or more images of the elongated probe and/or the tissue in substantially real-time using at least the RF imaging element and the MRI apparatus, thereby analyzing the tissue.

15 . The method of claim 14 , further comprising selectively deflecting at least one position of the elongated probe using the deflection mechanism.

16 . The method of claim 14 , comprising capturing the images of one or more tissue regions surrounding a hole in the tissue that comprise a diameter of up to about 100 mm around the hole, when the elongated probe is inserted in the hole in the tissue.

17 . The method of claim 14 , comprising capturing the images of the tissue along a length of a hole in the tissue that extends up to about 100 mm, when the elongation probe is inserted in the hole.

18 . The method of claim 14 , comprising analyzing the tissue in-situ in a subject.

19 . The method of claim 14 , wherein the device comprises at least a portion of at least one axial rotational control mechanism operably connected to the elongated probe and wherein the method further comprises indicating at least one rotational angle formed between at least a portion of the elongated probe and at least one template device that is positioned at least proximal to the tissue.

Assignments (3)

Continuity (4)

References Cited (26)