Tissue biopsy and treatment apparatus and method

• US 6,869,430 B2
• Filed: 03/30/2001
• Issued: 03/22/2005
• Est. Priority Date: 03/31/2000
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Rita Medical Systems Incorporated (AngioDynamics, Inc.)
• Inventors: Balbierz, Daniel J., Johnson, Theodore
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VRETTAKOS, PETER J
• Application Number:
  US09/823,903
• Publication Number:
  US 20020026127A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606 33- 52, 606/41, 606/12, 600/567
• US Class Current: 606/41
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00142 lubricating
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/0069 using fuzzy logic
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3941 : Photoluminescent markers
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 5/0071 : by measuring fluorescence emission
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: C08L 2201/12 : Shape memory

Abstract

An embodiment of the invention provides a tissue biopsy and treatment apparatus that comprises an elongated delivery device that is positionable in tissue and includes a lumen. A sensor array having a plurality of resilient members is deployable from the elongated delivery device. At least one of the plurality of resilient members is positionable in the elongated delivery device in a compacted state and deployable with curvature into tissue from the elongated delivery device in a deployed state. At least one of the plurality of resilient members includes at least one of a sensor, a tissue piercing distal end or a lumen. The sensor array has a geometric configuration adapted to volumetrically sample tissue at a tissue site to differentiate or identify tissue at the target tissue site. At least one energy delivery device is coupled to one of the sensor array, at least one of the plurality of resilient members or the elongated delivery device.

Claims

1. A tissue biopsy and treatment apparatus for detecting and treating tumors, the apparatus comprising:

an elongated delivery device including a lumen, the elongated delivery device being maneuverable in tissue;

a sensor array deployable from the elongated delivery device, the sensor array including a plurality of resilient members each having a tissue piercing distal portion, at least one of the plurality of resilient members being positionable in the elongated delivery device in a compacted state and deployable with curvature into tissue from the elongated delivery device in a deployed state, at least one of the plurality of resilient members including an optical sensor operatively connected to function as an emitter and a detector, the sensor array having a geometric configuration adapted to volumetrically sample tissue at a tissue site or identify tissue at a tissue site, and an optical switching device to switch a mode of said optical sensor;

at least some of said resilient members being electrodes which can be coupled to an RF energy source for ablating tissue when electrical energy is supplied to the electrodes from the source; and

wherein the sensor array is configured to measure a spectral profile of at least one portion of the tissue site.

2. The apparatus of claim 1, wherein the at least one portion includes a first portion and a second portion, the sensor array being configured to substantially simultaneously measure a first spectral profile of the first portion and a second spectral profile of the second portion.

3. The apparatus of claim 1, further comprising:

logic resources coupled to one of the sensor array, or the sensor; and

wherein the logic resources are configured to identify or differentiate tissue responsive to a signal from one of the sensor or the sensor array.

4. The apparatus of claim 3, wherein the logic resources are configured to distinguish between normal and abnormal tissue, wherein the abnormal tissue includes at least one of abnormally mutated tissue, abnormally dividing tissue, cancerous tissue, metastatic tissue, immortal tissue, or hypoxic tissue.

5. The apparatus of claim 3, wherein the logic resources are configured to locates position of the energy delivery device relative to one of a tumor mass or an ablation volume.

6. The apparatus of claim 5, wherein the logic resources are operatively connected to one of a monitoring device or a display device to signal the position of the energy delivery device relative to the tumor mass or to the ablation volume.

7. The apparatus of claim 6, wherein the logic resources are configured to interface with the display device to graphically display the position of the energy delivery device relative to the tumor mass or the ablation volume.

8. The apparatus of claim 3, wherein the logic resources are configured to identify a clinical endpoint for a tissue ablation procedure.

9. The apparatus of claim 1, wherein the optical sensor comprises at least one of a light conducting member or an optical fiber positionable within a lumen of at least one of the plurality of resilient members, wherein the light conducting member or the optical fiber is coupled to a light source or a coherent light source.

10. The apparatus of claim 9, wherein the sensor comprises an emitting and a detecting optical fiber positionable within the lumen of the at least one resilient member.

11. The apparatus of claim 1, wherein the plurality of resilient members includes a first resilient member having a first lumen with a first positionable optical sensing member and a second resilient member having a second lumen with a second positionable optical sensing member.

12. The apparatus of claim 11, wherein the, first sensing member is a first optical fiber configured as an emitter and a detector and the second optical sensing member is a second optical fiber configured as an emitter and a detector.

13. The apparatus of claim 1, at least one of the plurality of resilient members including a second sensor is configured to detect a change in a tissue property.

14. The apparatus of claim 13, wherein the property includes at least one of a physiologic property, a metabolic property, a thermal property, a temperature, an electrical property, an impedance, an optical property, an absorbance, a reflectance, a dimensional property, and a pH.

15. The apparatus of claim 1, wherein the sensor array is configured to detect an indicator of cell necrosis.

16. The apparatus of claim 15, wherein the indicator of cell necrosis is selected from the group consisting of a tissue vapor bubble, a rate of tissue vapor bubble formation, a denatured tissue protein, a denatured DNA, and an intracellular fluid.

17. The apparatus of claim 1, wherein the sensor array is configured to distinguish between non cancerous and cancerous tissue.

18. The apparatus of claim 1, further comprising:

at least one of (i) the elongated delivery device or (ii) at least one of the plurality of the plurality of resilient members being adapted for fluid delivery therethrough to an infusion port disposed on at least one of the elongated delivery device or at least one resilient member of the plurality of resilient members.

19. The apparatus of claim 1, further comprising:

a handpiece coupled to one of the elongated delivery device or the sensor array; and

a first advancement device at least partially positionable in one of the handpiece or the elongated delivery device, the advancement device being configured to advance at least one of the plurality of resilient members.

20. The apparatus of claim 19, further comprising:

a second advancement device at least partially positionable in one of the handpiece or the elongated delivery device, the second advancement device configured to advance a second resilient member of the at least one plurality of resilient members independent of an advancement of the first advancement device.

21. A tissue biopsy and treatment apparatus for detecting and treating tumors, the apparatus comprising:

an elongated delivery device including a lumen, the elongated delivery device being maneuverable in tissue;

a sensor array deployable from the elongated delivery device, the sensor array including a plurality of resilient members each having a tissue piercing distal portion, at least one of the plurality of resilient members being positionable in the elongated delivery device in a compacted state and deployable with curvature into tissue from the elongated delivery device in a deployed state, at least one of the plurality of resilient members including an optical sensor operatively connected to function as an emitter and a detector, the sensor array having a geometric configuration adapted to volumetrically sample and measure a spectral profile of at least one portion of a tissue site to differentiate or identify tissue at the tissue site, and an optical switching device to switch a mode of said optical sensor; and

at least some of said resilient members being electrodes which can be coupled to an RF energy source for ablating tissue when electrical energy is supplied to the electrodes from the sources.

22. A tissue biopsy and treatment apparatus for detecting and treating tumors, the apparatus comprising:

an elongated delivery device including a lumen, the elongated delivery device being maneuverable in tissue;

a sensor array deployable from the elongated delivery device, the sensor array including a plurality of resilient members each having a tissue piercing distal portion, at least one of the plurality of resilient members being positionable in the elongated delivery device in a compacted state and deployable with curvature into tissue from the elongated delivery device in a deployed state, at least one of the plurality of resilient members including an optical sensor operatively connected to function as an emitter and a detector, the sensor array having a geometric configuration adapted to volumetrically sample tissue at a tissue site or identify tissue at a tissue site, and an optical switching device to switch a mode of said optical sensor;

at least some of said resilient members being electrodes which can be coupled to an RF energy source for ablating tissue when electrical energy is supplied to the electrodes from the source;

wherein the sensor includes a first sensor and a second sensor; and

wherein at least one of the first or the second sensors is selected from the group consisting of an emitter, an electromagnetic emitter, an optical emitter, an acoustical emitter, a lasers and an LED.

23. The apparatus of claim 22, wherein the emitter is substantially positioned within a volume defined by the sensor array.

24. The apparatus of claim 22, wherein the emitter is substantially positioned outside of a volume defined by the sensor array.

25. The apparatus of claim 22, wherein the emitter emits a reference signal and a probe signal.

26. The apparatus of claim 25, wherein the sensor includes a third sensor adapted to detect the reference signal.

27. The apparatus of claim 26, wherein the third sensor is adapted to detect the reference signal with substantially no effect from tissue.

28. The apparatus of claim 27, wherein the third sensor is positioned substantially adjacent or in proximity to the emitter.

29. The apparatus of claim 22 wherein the emitter is configured to emit electromagnetic energy over a selectable frequency range.

30. A tissue biopsy and treatment apparatus for detecting and treating tumors, the apparatus comprising:

an elongated delivery device including a lumen, the elongated delivery device being maneuverable in tissue;

a sensor array deployable from the elongated delivery device, the sensor array including a plurality of resilient members each having a tissue piercing distal portion, at least one of the plurality of resilient members being positionable in the elongated delivery device in a compacted state and deployable with curvature into tissue from the elongated delivery device in a deployed state, at least one of the plurality of resilient members including an optical sensor operatively connected to function as an emitter and a detector, the sensor array having a geometric configuration adapted to volumetrically sample tissue at a tissue site or identify tissue at a tissue site, and an optical switching device to switch a mode of said optical sensor;

at least some of said resilient members being electrodes which can be coupled to an RF energy source for ablating tissue when electrical energy is supplied to the electrodes from the source; and

wherein the sensor array is configured to detect a marking agent.

31. The apparatus of claim 30, wherein the sensor array is configured to detect an absence of the marking agent.

32. The apparatus of claim 30, wherein the sensor array is configured to obtain one of an improved resolution or an improved sensitivity.

33. The apparatus of claim 30, comprising:

a source of marking agent fluidically coupled to one of the elongated delivery device or at least one of the plurality of resilient members.

34. The apparatus of claim 33, wherein the marking agent is selected from the group consisting of an optical marker, a fluorescent marker, a radioactive-marker, a temperature sensitive marker, an antibody, a liposome, an antibody-coated liposome, a microsphere, and a chemotherapeutic agent.

35. The apparatus of claim 33, wherein the marking agent is reactive to a delivery of energy.

36. The apparatus of claim 33, wherein the marking agent is configured to enhance at least one of the delivery of energy to a least a portion of the tumor volume or the degree of thermal injury to the at least a portion of the tumor volume.

37. The apparatus of claim 36, wherein the at least a portion of the tumor volume is a selectable portion.

38. The apparatus of claim 33, wherein the marking agent includes a plurality of marking agents.

39. The apparatus of claim 38, wherein the plurality of marking agents include a first marking agent configured to mark a first tissue condition or first tissue type and a second marking agent configured to mark a second tissue condition or a second tissue type.

40. The apparatus of claim 39, wherein at least one of the first or the second tissue conditions is a cancerous tissue condition.

41. The apparatus of claim 39, wherein at least one of the first or second tissue conditions is selected from the group consisting of a thermal injury condition, a tissue necrosis, a tissue ablation, a tissue vaporization, a tissue coagulation, and a cell membrane rupture.

42. The apparatus of claim 39, wherein the first tissue condition is a cancerous condition and the second tissue condition is a thermal injury condition.

43. The apparatus of claim 39, wherein the first tissue condition is a first tissue temperature and the second condition is a second tissue temperature.

44. The apparatus of claim 43, wherein the second tissue temperature is selected from the group consisting of a tissue injuring temperature, a tissue necrosing temperature, a tissue ablative temperature, and a tissue vaporization temperature.

45. The apparatus of claim 39, wherein the plurality of marking agents includes a third marking agent.

46. The apparatus of claim 38, wherein the plurality of marking agents includes a first marking agent coupled to a first marking agent carrier, wherein the first marking agent carrier is configured to release the first marking agent at a selectable temperature, tissue condition or tissue chemical concentration.

47. The apparatus of claim 46, wherein the selectable temperature is in the range of about 40°

C. to about 60°

C.

48. The apparatus of claim 46, wherein the selectable temperature is in the range of about 45°

C. to about 55°

C.

49. The apparatus of claim 46, wherein the plurality of marking agents includes a second marking agent coupled to a second marking agent carrier, wherein the second marking agent carrier is configured to release the first marking agent at a selectable temperature.

50. The apparatus of claim 49, wherein the second selectable temperature is in the range of about 40°

C. to about 60°

C.

52. The apparatus of claim 33, wherein the marking agent is configured to detect one of a gene, a gene fragment, a genetic variant, a genetic mutation, a DNA sequence, a DNA fragment and an expressed sequence tag.

51. The apparatus of wherein the second selectable temperature is in the range of about 45°

C. to about 55°

C.