Clean margin assessment tool

• US 20060253107A1
• Filed: 03/23/2005
• Published: 11/09/2006
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Dune Medical Devices Ltd. (Dilon Technologies LLC)
• Original Assignee: Dune Medical Devices Ltd. (Dilon Technologies LLC)
• Inventors: Geltner, Iddo, Hashimshony, Dan, Cohen, Gil
• Granted Patent: US 7,720,532 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/367 creating a 3D dataset from 2D images using position information
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/0091 for mammography
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/415 : the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/4312 : Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• 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 8/4245 : involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
• CPC Class Codes: A61B 8/4472 : Wireless probes

Abstract

An integrated tool is provided, having a tissue-type sensor, for determining the tissue type at a near zone volume of a tissue surface, and a distance-measuring sensor, for determining the distance to an interface with another tissue type, for (i) confirming an existence of a clean margin of healthy tissue around a malignant tumor, which is being removed, and (ii) determining the depth of the clean margin. The integrated tool may further include a position tracking device and an incision instrument. The soft tissue may be held within a fixed frame, while the tumor is being removed. Additionally a method for malignant tumor removal is provided, comprising, fixing the soft tissue within a frame, performing imaging with the hand-held, integrated tool, from a plurality of locations and orientations around the soft tissue, reconstructing a three-dimensional image of the soft tissue and the tumor within, defining a desired clean margin on the reconstructed image, calculating a recommended incision path, displaying the recommended path on the reconstructed image, and cutting the tissue while determining its type, at the near zone volume of the incision surface. The method may further include continuously imaging with the cutting, continuously correcting the reconstructed image and the recommended incision path, and continuously determining the tissue type, at the near zone volume of the incision surface.

Claims

1. An integrated tool, for clean-margin assessment, comprising:

a structure, which defines a proximal end with respect to a tissue and which is adapted for placement proximally to the tissue;

a tissue-type sensor, mounted on the structure, for determining a tissue type at a near zone volume of a tissue surface; and

a distance-measuring sensor, mounted on the structure, for determining a distance between the tissue surface and an interface with another tissue type,

wherein the integrated tool is configured as a hand-held tool.

2. The integrated tool of claim 1, wherein the another tissue type is a cancerous tissue, and the integrated tool may be used to assess:

whether the tissue type at the near zone volume of the tissue surface is healthy; and

the distance between the tissue surface and an interface with the cancerous tissue.

3. The integrated tool of claim 1, adapted for operation in tandem with a surgical tool, for a real-time correction of a clean margin, where necessary.

4. The integrated tool of claim 1, and further including an incision instrument, integrated therewith, for a real-time correction of a clean margin, where necessary.

5. The integrated tool of claim 4, wherein the incision instrument may be selectively retracted and selectively deployed.

6. The integrated tool of claim 4, wherein the incision instrument is a diathermial incision instrument.

7. The integrated tool of claim 1, wherein the tissue-type sensor is selected from the group consisting of a sensor for tissue electromagnetic properties, a dielectric sensor, an impedance sensor, a sensor for optical fluorescence spectroscopy, a sensor for optical reflectance spectroscopy, an MRI sensor, an RF sensor, an MW sensor, a temperature sensor, and infrared thermography sensor.

8. The integrated tool of claim 1, wherein the tissue-type sensor is a dielectric-property sensor, formed substantially as a coaxial cable.

9. The integrated tool of claim 1, wherein the tissue surface is selected from the group consisting of a skin, a tissue lumen, and an incision surface.

10. The integrated tool of claim 1, wherein the distance-measuring sensor is an ultrasound transducer.

11. The integrated tool of claim 1, wherein the distance-measuring sensor is formed of two ultrasound transducers.

12. The integrated tool of claim 1, wherein the distance-measuring sensor is formed of an array of ultrasound transducers, which may be selectively steered.

13. The integrated tool of claim 1, wherein the distance-measuring sensor is selected from the group consisting of a strain gauge and a pressure sensor.

14. The integrated tool of claim 1, wherein the distance-measuring sensor is an MRI probe.

15. The integrated tool of claim 1, operative with a guide wire, wherein a proximal tip of the guide wire, with respect to the tissue, is placed within the another tissue type.

16. The integrated tool of claim 1, operative with a guide wire, wherein a proximal tip of the guide wire, with respect to the tissue, is placed in close proximity with the another tissue type.

17. The integrated tool of claim 1, operative with a guide wire, wherein the distance-measuring sensor is an ultrasound transducer, and the guide wire further includes a guide wire ultrasound transducer, at a proximal tip thereof, with respect to the tissue, for emitting ultrasound signals, indicative of the proximal-tip distance from the integrated tool.

18. The integrated tool of claim 1, operative with a guide wire, wherein the distance-measuring sensor is an ultrasound transducer, and the guide wire further includes a guide wire ultrasound transducer, at a proximal tip thereof, with respect to the tissue, for emitting ultrasound signals, indicative of the proximal-tip position with respect to the integrated tool, by triangulation.

19. The integrated tool of claim 1, and further including a position-tracking device.

20. The integrated tool of claim 19, wherein the position-tracking device is correlated with a coordinate system of a fixed frame, within which, the tissue is held fixed in place.

21. A system for clean-margin assessment, comprising:

a hand-held, integrated tool, for clean-margin assessment, which comprises;

a structure, which defines a proximal end with respect to a tissue and which is adapted for placement proximally to the tissue;

a tissue-type sensor, mounted on the structure, for determining a tissue type at a near zone volume of a tissue surface; and

a distance-measuring sensor, mounted on the structure, for determining a distance between the tissue surface and an interface with another tissue type; and

a computerized system, which comprises;

a tissue-type-sensor analyzer, associated with the tissue-type sensor;

a distance-measuring-sensor analyzer, associated with the distance-measuring sensor; and

an output device, which provides output of measurements by the tissue-type sensor and the distance-measuring sensor.

22. The system of claim 21, wherein the another tissue type is a cancerous tissue, and the integrated tool may be used to assess:

whether the tissue type at the near zone volume of the tissue surface is healthy; and

the depth to an interface with the cancerous tissue.

23. The system of claim 21, and further including a fixed frame for holding the tissue therein.

24. The system of claim 21, and further including a position-tracking device and a position-tracking-device analyzer.

25. The system of claim 21, and further including a computer.

26. A system for clean-margin assessment, comprising:

a fixed frame for holding a tissue therein, the frame defining a coordinate system;

a hand-held, integrated tool, for clean-margin assessment, which comprises;

a structure, which defines a proximal end with respect to the tissue and which is adapted for placement proximally to the tissue;

a tissue-type sensor, mounted on the structure, for determining a tissue type at a near zone volume of a tissue surface;

an imager, operative as a distance-measuring sensor, mounted on the structure, for determining a distance between the tissue surface and an interface with another tissue type; and

a position-tracking device, mounted on the structure and correlated with the coordinate system; and

a computerized system, which comprises;

a tissue-type-sensor-analyzer, associated with the tissue-type sensor;

a distance-measuring-sensor analyzer, associated with the distance-measuring sensor;

a position-tracking-device analyzer, associated with the position-tracking device;

a computer, for receiving data from the tissue-type-sensor analyzer, the distance-measuring-sensor analyzer, and the position-tracking-device analyzer, and performing analysis thereof; and

an output device, associated with the computer.

27. A method of clean-margin assessment, comprising:

providing a hand-held, integrated tool, for clean-margin assessment, which comprises;

a structure, which defines a proximal end with respect to a tissue and which is adapted for placement proximally to the tissue;

a tissue-type sensor, mounted on the structure, for determining a tissue type at a near zone volume of a tissue surface; and

a distance-measuring sensor, mounted on the structure, for determining a distance between the tissue surface and an interface with another tissue type;

determining the tissue type at the near zone volume of the tissue surface; and

determining the distance between the tissue surface and the interface with the another tissue type.

28. A method of clean-margin assessment, comprising:

providing a hand-held, integrated tool, for clean-margin assessment, which comprises;

a structure, which defines a proximal end with respect to a tissue and which is adapted for placement proximally to the tissue;

a tissue-type sensor, mounted on the structure, for determining a tissue type at a near zone volume of a tissue surface;

a non-invasive imager, mounted on the structure; and

a position-tracking device, mounted on the structure;

fixing the tissue within a fixed frame, which defines a coordinate system;

imaging the tissue, from at least two locations and orientations, by the hand-held, integrated tool;

reconstructing a three dimensional image of the tissue;

displaying the three dimensional image of the tissue;

defining a desired clean margin around another tissue type;

displaying the desired clean margin;

calculating a recommended incision path;

displaying the recommended incision path;

providing an incision instrument;

cutting along the recommended incision path; and

determining the tissue type at the near zone volume of the tissue surface, by the hand-held, integrated tool.

29. The method of claim 28, and further including:

continuously imaging the tissue, from different locations and orientations along the tissue surface, by the hand-held, integrated tool;

continuously correcting the recommended incision path; and

continuously displaying the continuously corrected recommended incision path.

30. The method of claim 29, and further including continuously determining the tissue type, at the near zone volume of the incision surface, by the hand-held, integrated tool.