Systems, devices and methods for tissue removal and analysis

• US 9,883,854 B2
• Filed: 04/08/2015
• Issued: 02/06/2018
• Est. Priority Date: 04/08/2015
• Status: Active Grant

• Current Assignee: Synaptive Medical (Barbados) Inc.
• Original Assignee: Synaptive Medical (Barbados) Inc.
• Inventors: Mak, Siu Wai Jacky
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US15/025,749
• Publication Number:
  US 20170035399A1
• Time in Patent Office: 1,035 Days
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: G01N 21/658 enhancement Raman, e.g. surface plasmons
• CPC Class Codes: G01N 33/483 Physical analysis of biological material
• CPC Class Codes: G01N 33/4833 of solid biological material, e.g. tissue samples, cell cultures tissue in vivo A61B5/00; cell suspensions G01N33/48735
• CPC Class Codes: G01N 33/487 of liquid biological material

Abstract

Systems, devices and methods are provided for performing tissue removal and analysis based on the in-situ optical analysis of tissue and of liquid collected from the tissue region. In one example embodiment, a tissue removal and analysis probe includes an elongate tissue removal device, an optical fiber, and a fluid fillable conduit, where distal ends of the optical fiber and the conduit are in communication with an external region that is adjacent to a distal functional portion of the tissue removal device. The results of optical analysis one of both of external tissue and collected fluid may be employed to determine whether or not tissue removal is to be carried out. Various devices may be interfaced with the conduit for optical analysis of the collected fluid. In one example embodiment, the tissue removal device may be movable relative to the optical fiber and conduit.

Claims

1. An in-situ tissue removal and analysis system comprising:

a tissue removal and analysis probe comprising;

an elongate tissue removal device having a distal portion comprising a sampling region which is configured to contact a tissue sample of a patient in an external region adjacent to said distal portion;

an optical fiber having a distal end in optical communication with the external region;

a fluid-fillable conduit having a distal aperture in fluid communication with the external region for collecting a fluid sample from the tissue sample in the external region; and

an optical detection subsystem configured to be in optical communication with a proximal end of said optical fiber and with at least a portion of the fluid sample collected by said fluid-fillable conduit;

wherein said optical detection subsystem is configured to direct first incident optical energy into said optical fiber and to detect first received optical energy that is responsively produced within the external region; and

wherein said fluid-fillable conduit forms an optical waveguide when filled with the fluid sample; and

wherein said optical detection subsystem is configured to direct second incident optical energy into said optical waveguide, and to detect second received optical energy that is responsively emitted from the fluid sample within said optical waveguide; and

wherein said optical detection subsystem is configured to measure a first spectrum based on said first received optical energy and a second spectrum based on the second received optical energy, wherein one or more of said first spectrum and said second spectrum is a Raman spectrum; and

processing circuitry comprising a processor and a memory, wherein the memory is programmed with instructions, which when executed by said processor, perform the following steps;

processing signals associated with the detection of (i) the first received optical energy from tissue residing within the external region and (ii) the second received optical energy from the fluid sample collected within the fluid-fillable conduit in order to determine whether one more pre-selected criteria associated with the presence of diseased tissue are met;

whereby if the pre-selected criteria are met the elongate tissue removal device is controlled to remove the tissue sample from the patient.

2. The in-situ tissue removal and analysis system according to claim 1 wherein said fluid-fillable conduit is a hollow optical fiber.

3. The in-situ tissue removal and analysis system according to claim 1 wherein said fluid-fillable conduit is a capillary tube.

4. The in-situ tissue removal and analysis system according to claim 1 wherein said fluid-fillable conduit is a photonic crystal fiber.

5. The in-situ tissue removal and analysis system according to claim 1 further comprising:

a microfluidic device in flow communication with said fluid-fillable conduit, wherein said microfluidic device is configured to optically interface at least a portion of the fluid sample collected by said fluid-fillable conduit with said optical detection subsystem.

6. The in-situ tissue removal and analysis system according to claim 1 wherein said fluid-fillable conduit comprises at least one confined dimension suitable for filling at least a portion of said fluid-fillable conduit via capillary forces.

7. The in-situ tissue removal and analysis system according to claim 1 further comprising a flow mechanism in fluid communication with said fluid-fillable conduit for drawing the fluid sample into said fluid-fillable conduit.

8. The in-situ tissue removal and analysis system according to claim 7 wherein said flow mechanism is interfaced with said fluid-fillable conduit through a lateral port that permits optical communication between said optical detection subsystem and the fluid sample.

9. The in-situ tissue removal and analysis system according to claim 1 wherein said elongate tissue removal device comprises:

a cannula having sampling region configured receive a tissue sample at said distal portion; and

a cutting mechanism associated with said cannula for cutting tissue received within said sampling region;

wherein said cannula is connectable to a suction mechanism for drawing tissue into said sampling region.

10. The in-situ tissue removal and analysis system according to claim 1 wherein said elongate tissue removal device is configured for performing biopsy or tissue resection.

11. The in-situ tissue removal and analysis system according to claim 1 wherein said optical detection subsystem is configured such that one or more of the first spectrum and the second spectrum is a fluorescence spectrum.

12. The in-situ tissue removal and analysis system according to claim 1 wherein said optical fiber and said fluid-fillable conduit are retractable relative to said distal portion.

13. The in-situ tissue removal and analysis system according to claim 1 wherein said optical fiber is a first optical fiber, wherein the tissue removal and analysis system comprises an additional optical fiber having a distal end in optical communication with the external region, and wherein said optical detection subsystem is configured to be in optical communication with said additional optical fiber.

14. The in-situ tissue removal and analysis system according to claim 13 wherein said optical detection subsystem is configured direct additional incident optical energy into said additional optical fiber, and to detect an optical coherence tomography signal that is responsively produced within the external region.

15. The system according to claim 1 wherein said processing circuitry is further configured to process a plurality of spatially-dependent signals associated with the detection of the first received optical energy and the second received optical energy to determine a location of a tumor margin.

16. A method of performing tissue removal based on in-situ optical tissue analysis,

the method comprising, after positioning the distal portion of a tissue removal and analysis probe adjacent to a tissue region;

collecting, within the conduit, fluid from the tissue region;

directing the first incident optical energy into the optical fiber and detecting first received optical energy that is responsively produced within the tissue region, thereby obtaining first received signals;

directing the second incident optical energy into the fluid collected by the fluid-fillable conduit, and detecting the second received optical energy that is responsively produced within the fluid sample, thereby obtaining second received signals;

processing (i) the first received signals associated with the detection of the first received optical energy from tissue residing within the external region to measure a first spectrum based on said first received optical energy and (ii) the second received signals associated with the detection of the second received optical energy from the fluid sample collected within the fluid-fillable conduit to measure a second spectrum based on the second received optical energy, to determine whether one more pre-selected criteria associated with the presence of diseased tissue are met;

wherein one or more of said first spectrum and said second spectrum is a Raman spectrum;

and whereby if the one or more pre-selected criteria are met the tissue removal and analysis probe is controlled to remove the tissue sample from the patient.

17. The method according to claim 16 further comprising employing the tissue removal device to perform tissue removal in the event that one or more of the criteria are satisfied.

18. The method according to claim 16 wherein the first received signals and the second received signals are obtained at different spatial locations and processed to determine a location of a tumor margin.