Diagnosis and treatment of tissue with instruments

• US 6,063,031 A
• Filed: 10/14/1997
• Issued: 05/16/2000
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: Medical Tactile, Inc.
• Original Assignee: Assurance Medical, Inc.
• Inventors: Widder, David Raymond, Roberts, Troy William, West, Alan Irving, Cundari, Michael Anthony
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/950,167
• Time in Patent Office: 945 Days
• Field of Search: 600/407, 600/567, 600/561, 600/587, 600/437-444, 600/461, 600/471, 600/585
• US Class Current: 600/439
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• 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 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence

Abstract

A device is provided for diagnosis and treatment of tissue with instruments, specifically locating a tissue structure and positioning an instrument relative to that tissue structure. The device which includes a plurality of sensors for generating signals in response to pressure imposed on the sensors as the sensors are pressed against the tissue. The device which includes a member which is configured to be pressed against tissue and the sensors are disposed on the member, for detection of an underlying tissue structure in the tissue. The device also includes a locating device, arranged at a selected position with respect to the sensors, for indicating a location of the underlying tissue structure. An image based on the sensors may be displayed. The method of using the device includes positioning the locating device, which may be an instrument guide, over an underlying tissue structure based on the image. The method further includes using the locating device to direct an instrument for treating or diagnosing a tissue structure towards that tissue structure.

Claims

1. A device comprising

a first member and a second member each of which is configured to be pressed against tissue,

a first plurality of sensors and a second plurality of sensors respectively disposed on said first member and said second member for generating signals in response to pressure imposed thereon by underlying tissue when said the respective member is pressed against the tissue for detection of an underlying tissue structure in the tissue, and

a locating device, coupled to said first member and said second member at a selected position with respect to said first plurality of sensors and said plurality of sensors, for indicating a location of the structure based on the signals generated by said first plurality of sensors and said second plurality of sensors, said locating device being an instrument guide for use with an instrument for diagnosing or treating the underlying tissue structure.

2. The device of claim 1 wherein said instrument guide is configured to be used with a medical instrument comprising at least one of a group comprising surgical instruments, laser fibers, RF electrodes, cryogenic probes, and devices for implanting materials in the underlying tissue structure, wherein said material comprises at least one of a group comprising radioisotopes, drugs, biologic agents, and alcohol.

3. The device of claim 1 further comprising a lubricant disposed between the each said plurality of sensors and the tissue.

4. The device of claim 1 wherein said instrument guide comprises a biopsy instrument guide.

5. The device of claim 1 wherein said guide includes a cannula mounted to said members at the selected position and having a passage sized to receive an instrument for diagnosing or treating the underlying tissue structure.

6. The device of claim 5 wherein said first plurality of sensors and said second plurality of sensors are respectively disposed on a lower surface of said first member and said second member, said cannula being attached to said members so that said passage is arranged at the selected position.

7. The device of claim 6 wherein said first plurality of sensors and said second plurality of sensors are arranged in arrays, and said passage is arranged between said arrays.

8. The device of claim 1 further comprising

a processor for generating an image of the underlying tissue structure based on said signals, and

a display device for displaying said image.

9. The device of claim 8 wherein said processor is configured to produce an indicator of said selected position of the locating device relative to the image of the underlying tissue structure for display on said display device with said image.

10. The device of claim 9 wherein said processor is further configured to cause said indicator to be substantially aligned with a portion of said image on said display device if a corresponding portion of the underlying tissue structure is positioned beneath said instrument guide.

11. The device of claim 1 wherein said guide includes a cannula mounted between the first member and said second member at the selected position, said cannula having a passage sized to receive an instrument for diagnosing or treating the underlying tissue structure.

12. The device of claim 11 further comprising

a processor for generating a first image of the underlying tissue structure based on said signals produced by the first sensors, and generating a second image of the underlying tissue structure based on said signals produced by the second sensors, and

a display device for displaying said first image and said second image.

13. The device of claim 12 wherein said processor is configured to cause said first image and said second image to be displayed on said display device in a manner that indicates a location of the underlying tissue structure relative to said instrument guide.

14. The device of claim 13 wherein said processor is further configured to cause said first image and said second image to be substantially aligned with each other on said display device if the underlying tissue structure is positioned beneath said instrument guide.

15. The device of claim 1 wherein the first member and said second member are pivotally mounted with respect to said instrument guide to allow said members to be pivoted with respect to each other so that an underlying tissue structure is disposed beneath and between said members, and further comprising

a measurement device for determining a pivot angle of one of said members,

said processor being configured to determine a depth of the underlying tissue structure beneath a surface of the tissue based on said angle and said signals generated by the first plurality of sensors and said second plurality of sensors.

16. The device of claim 15 wherein said processor is further configured to cause an indication of the depth of the underlying tissue structure to be displayed on a display device.

17. The device of claim 15 wherein said instrument guide includes a cannula having a selected length passage sized to receive an instrument for diagnosing or treating the underlying tissue structure, and further comprising an instrument for diagnosing or treating the underlying tissue structure having an adjustable length, thereby to allow a user to set the length of said instrument to the selected length of the cannula passage plus the depth of the underlying tissue structure determined by said processor.

18. A method comprising

providing a device that includes:

(1) a first member and a second member having a first plurality of sensors and a second plurality of sensors respectively disposed thereon for generating signals in response to pressure imposed thereon by underlying tissue when said first member and said second member are pressed against the tissue for detection of an underlying tissue structure in the tissue, and (2) a locating device, coupled to said first member and said second member at a selected position with respect to said first plurality of sensors and said second plurality of sensors, for indicating a location of the structure based on the signals generated by said first plurality of sensors and said second plurality of sensors, said locating device being an instrument guide for use with an instrument for diagnosing or treating the underlying tissue structure,

pressing said first member and said second member against the tissue, and

positioning said locating device relative to an underlying tissue structure based on the signals generated by said first plurality of sensors and said second plurality of sensors.

19. The method of claim 18 wherein said instrument guide is configured to be used with a medical instrument comprising at least one of a group comprising biopsy instruments, surgical instruments, laser fibers, RF electrodes, cryogenic probes, and devices for implanting materials in the underlying tissue structure, wherein said material comprises at least one of a group comprising radioisotopes, drugs, biologic agents, and alcohol, and the method further comprising

using said instrument guide to direct said medical instrument to the underlying tissue structure to treat or diagnose the underlying tissue structure.

20. The method of claim 18 further comprising:

using a lubricant between the each said plurality of sensors and the tissue.

21. The device of claim 18 wherein said instrument guide comprises a biopsy instrument guide.

22. The method of claim 18 further comprising generating an image of an underlying tissue structure based on said signals,

displaying said image on a display device, and

performing said positioning step based on a position of the image on the display device.

23. The method of claim 22 further comprising

displaying an indicator of said selected position of the locating device relative to the image of the underlying tissue structure on said display device with said image, and

performing said positioning step by manipulating said member first member and said second on the tissue to produce relative movement between said indicator and said image on said display device until said indicator is substantially aligned with a portion of said image on said display device, thereby indicating that a corresponding portion of the underlying tissue structure is positioned beneath said instrument guide.

24. The method of claim 23 wherein said first plurality of sensors and said second plurality of sensors are respectively disposed on a lower surface of said first member and said second member, said guide including a cannula attached to said members so that a passage of said cannula is arranged at the selected position, said indicator indicating a position of said passage, and further comprising inserting the instrument for diagnosing or treating the underlying tissue structure through said cannula passage to diagnose or treat the underlying tissue structure when said indicator is substantially aligned with a portion of said image on said display device.

25. The method of claim 18 further comprising

generating a first image of the underlying tissue structure based on said signals produced by the first plurality of sensors, and generating a second image of the underlying tissue structure based on said signals produced by the second plurality of sensors,

displaying said first image and said second image on a display device, and

performing the positioning step based on relative positions of said first image and said second image on the display device.

26. The method of claim 25 further comprising

manipulating said device on the tissue to cause said first image and said second image to move with respect to each other on said display device until portions of said images are substantially aligned on said display device, thereby indicating that a corresponding portion of the underlying tissue structure is positioned beneath said instrument guide, and

using said guide to direct an instrument for diagnosing or treating the underlying tissue structure to the corresponding portion of the underlying tissue structure.

27. The method of claim 18 further comprising determining a depth of the underlying tissue structure based on said signals produced by the first plurality sensors and said signals produced by the second plurality of sensors.

28. The method of claim 27 further comprising displaying an indication of the depth of the underlying tissue structure on said display device.

29. The method of claim 18 wherein the instrument guide includes a cannula and said first member and said second member are pivotally mounted with respect to said cannula, and further comprising

pivoting said members with respect to each other so that the underlying tissue structure is disposed beneath and between said members,

determining a pivot angle of one of said members, and

determining a depth of the underlying tissue structure beneath a surface of the tissue based on said angle and said signals generated by the first plurality of sensors and said second plurality of sensors.

30. The method of claim 29 wherein said cannula has a selected length passage sized to receive an instrument for diagnosing or treating the underlying tissue structure, and further comprising

providing an instrument for diagnosing or treating the underlying tissue structure, the instrument having an adjustable length, and

adjusting the length of the instrument to the selected length of the cannula passage plus the determined depth of the underlying tissue structure.