Minimally invasive surgical probe for tissue identification and retrieval and method of use

• US 5,961,458 A
• Filed: 11/18/1997
• Issued: 10/05/1999
• Est. Priority Date: 11/18/1997
• Status: Expired due to Term

• Current Assignee: Southern Scientific Limited (Lablogic Systems Ltd.)
• Original Assignee: Care Wise Medical Products Corporation
• Inventors: Carroll, Robert G.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US08/972,598
• Time in Patent Office: 686 Days
• Field of Search: 600/431, 600/436, 600/562, 600/567, 604/19, 604/20, 604/22, 604/27, 604/28, 604/35, 607/96, 606/167, 606/185, 606/186, 250/336.1, 250/363.01, 250/363.1, 250/362, 250/370.01, 250/370.11-370.12
• US Class Current: 600/436
• 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 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00079 Radioactivity
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/4057 by using radiation sources located in the interior of the body A61B6/037 takes precedence
• CPC Class Codes: A61B 6/425 using detectors specially adapted to be used in the interior of the body
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/4423 related to hygiene or sterilisation
• CPC Class Codes: G01T 1/161 Applications in the field of nuclear medicine, e.g. in vivo counting apparatus for radiation diagnosis A61B6/00

Abstract

A probe for detecting and removing radioactively tagged tissue, e.g., a sentinel lymph node, within the body of a living being. The probe is arranged to be inserted through a small percutaneous portal into the patient'"'"'s body and is movable to various positions adjacent the tagged tissue to detect the presence of radiation therefrom so that the probe can be positioned immediately adjacent that tissue to ensnare or trap it. The probe can then be removed from the being'"'"'s body, carrying the tagged tissue with it. The probe may be constructed to make use of a scintillation crystal, a collimator, adjustable or fixed, and a backshielding lightpipe.

Claims

1. A hand-holdable instrument for minimally invasive percutaneous introduction within the body of a living being for detecting radiation emanating from radioactively tagged tissue within the being'"'"'s body, said instrument comprising a probe and at least one, thin, elongated extendable member, said probe including a radiation detector arranged to determine the location of the radioactively tagged tissue from within the body of the being to enable the instrument to be moved so that said radiation detector is adjacent to the radioactively tagged tissue, said at least one extendable member being located adjacent said radiation detector and arranged to be extended out of said probe to ensnare the radioactively tagged tissue and to secure it as a unit to said probe, whereupon said instrument may be moved with respect to the being'"'"'s body to remove the radioactively tagged tissue as a unit from the being'"'"'s body so as to cause minimal disruption of the tagged tissue.

2. The instrument of claim 1 wherein said instrument includes plural, thin, elongated extendable members to pierce into the radioactively tagged tissue from plural directions to ensnare the radioactively tagged tissue.

3. The instrument of claim 1 wherein said probe comprises a body member including a radiation blocking material, said radiation detector being located within said body member, said body member having a distal end portion and a proximal end portion, said proximal end portion being arranged to be held in the hand of a user, said distal end portion being arranged to be directed toward a suspected location of the radioactively tagged tissue, said at least one extendable member being extendable from said distal end portion.

4. The instrument of claim 1 wherein said radiation detector comprises a scintillation crystal.

5. The instrument of claim 4 wherein said radiation detector has a solid angle of acceptance of radiation and wherein said instrument comprises a collimator for establishing the solid angle of acceptance of said radiation detector to radiation emanating from said radioactively tagged tissue.

6. The instrument of claim 5 wherein said radiation detector comprises a crystal and where said instrument additionally comprises a backshielding member located proximally of said crystal to block radiation from the proximal direction to said crystal.

7. The instrument of claim 1 including a suction passageway.

8. The instrument of claim 1 wherein said probe comprises a tubular sheath, said radiation detector being arranged to be releasably located within said tubular sheath, said tubular sheath including said at least one extendable member.

9. The instrument of claim 8 wherein said tubular sheath comprises a disposable material.

10. The instrument of claim 1 wherein said radiation detector has a solid angle of acceptance of radiation and wherein said instrument comprises a collimator, said collimator establishing the solid angle of acceptance of the radiation detector to the radiation emanating from the radioactively tagged tissue.

11. The instrument of claim 10 wherein said collimator is adjustable to adjust said solid angle of acceptance.

12. The instrument of claim 11 wherein said adjustable collimator includes at least one movable member arranged to be moved from a first position establishing a first, solid angle of acceptance of said radiation detector, and to a second position establishing a second and narrower solid angle of acceptance of said radiation detector.

13. The instrument of claim 1 additionally comprising diathermy means for applying energy to the radioactively tagged tissue.

14. The instrument of claim 1 wherein said at least one extendable member is barbed.

15. The instrument of claim 1 wherein said probe has a longitudinal axis and wherein said at least one extendable member is arranged to be extended at an acute angle to said longitudinal axis.

16. The instrument of claim 15 wherein said at least one extendable number is adjustable and is arranged to be extended at an adjustable angle to said longitudinal axis.

17. The instrument of claim 1 additionally comprising means for introducing a biologically active material adjacent the radioactively tagged tissue.

18. The instrument of claim 1 wherein said radiation detector comprises a crystal and where said instrument additionally comprises a backshielding member located proximally of said crystal to block radiation from the proximal direction to said crystal.

19. The instrument of claim 18 wherein said backshielding member comprises a lightpipe.

20. The instrument of claim 19 wherein said lightpipe comprises a material selected from the group consisting of undoped Gadolineum Orthosilicate, undoped Bismuth Germinate, undoped Cesium Iodide, and lead-glass.

21. The instrument of claim 20 additionally comprising an optical interface and wherein said lightpipe is connected to said crystal via said optical interface, said optical interface comprising either an optical coupling gel or adhesive.

22. The instrument of claim 20 wherein said crystal and said lightpipe are an integral unit comprising a material selected from the group consisting of undoped Gadolineum Orthosilicate, undoped Bismuth Germinate, undoped Cesium Iodide, and wherein said crystal comprises a scintillation doped portion of said material.

23. A method of removing radioactively tagged tissue within a living being'"'"'s body, the radioactively tagged tissue having radiation emanating therefrom, said method comprising the steps of:

(a) providing a probe device having a radiation detector and at least one, thin elongated extendable member,

(b) minimally invasively introducing said probe device within the body of the being for detecting radiation emanating from the radioactively tagged tissue within the being'"'"'s body by said radiation detector,

(c) positioning the probe device so that said radiation detector is located adjacent the radioactively tagged tissue,

(d) operating said probe device to cause said at least one extendable member to ensnare the radioactively tagged tissue, and

(e) removing the probe and the snared tissue as a unit from the being'"'"'s body so as to cause minimal disruption of the tagged tissue.

24. The method of claim 23 wherein said radioactively tagged tissue is located within the a cavity, duct, lumen or vessel in the body of the being, and wherein said probe device is introduced with minimal invasion of the being'"'"'s body.

25. The method of claim 23 wherein said radioactively tagged tissue is located within an organ in the body of the being, and wherein said probe device is introduced with minimal invasion of the being'"'"'s body.

26. The method of claim 23 wherein said radioactively tagged tissue is located interstitially, and wherein said probe device is introduced with minimal invasion of the being'"'"'s body.

27. The method of claim 23 wherein said radioactively tagged tissue comprises a lymph node.

28. The method of claim 23 additionally comprising the step of providing suction adjacent said radioactively tagged tissue to facilitate the holding of said tissue.

29. The method of claim 23 additionally comprising the step of providing suction adjacent said radioactively tagged tissue to remove blood and/or other fluids.

30. The method of claim 23 additionally comprising the step of introducing a flowable material adjacent the radioactively tagged tissue to minimize the migration of cells therefrom.

31. The method of claim 23 additionally comprising the step of introducing a biologically active material adjacent the radioactively tagged tissue.

32. The method of claim 23 wherein said probe device includes a body portion, and wherein said at least one extendable member is arranged to be held in a retracted position with respect to said body portion of said probe device, and wherein said method comprises extending said at least one extendable member from said retracted position to an extended position to pierce and snare the radioactively tagged tissue.

33. The method of claim 32 additionally comprising the step of providing energy to the radioactively tagged tissue.

34. The method of claim 33 wherein said energy is applied by diathermy means forming a portion of said probe device.

35. A hand-holdable instrument for minimally invasive percutaneous introduction within the body of a living being for detecting radiation emanating from a lymph node tagged with a radioactive agent and for efficiently removing that lymph node from the body of the being, said instrument comprising a probe and at least one, thin, elongated extendable member, said probe including a radiation detector arranged to determine the location of the radioactively tagged lymph node from within the body of the being to enable the instrument to be moved so that said radiation detector is adjacent to the radioactively tagged lymph node, said at least one extendable member being constructed and arranged to be extended out of said probe to engage into the radioactively tagged lymph node with minimal disturbance of the tissue of the lymph node to ensnare the lymph node, whereupon said instrument may be moved with respect to the being'"'"'s body to efficaciously remove the radioactively tagged lymph node as a unit from the being'"'"'s body so as to cause minimal disruption of the tagged lymph node.

36. The instrument of claim 35 wherein said instrument includes plural, thin, elongated extendable members to pierce into the radioactively tagged lymph node from plural directions to ensnare it.

37. The instrument of claim 35 wherein said probe comprises a body member including a radiation blocking material, said radiation detector being located within said body member, said body member having a distal end portion and a proximal end portion, said proximal end portion being arranged to be held in the hand of a user, said distal end portion being arranged to be directed toward a suspected location of the radioactively tagged lymph node, said at least one extendable member being extendable from said distal end portion.

38. The instrument of claim 35 wherein said radiation detector comprises a scintillation crystal.

39. The instrument of claim 38 wherein said radiation detector has a solid angle of acceptance of radiation and wherein said device comprises a collimator for establishing the solid angle of acceptance of said radiation detector to radiation emanating from said radioactively tagged lymph node.

40. The instrument of claim 39 wherein said radiation detector comprises a crystal and where said instrument additionally comprises a backshielding member located proximally of said crystal to block radiation from the proximal direction to said crystal.

41. The instrument of claim 35 including a suction passageway.

42. The instrument of claim 35 wherein said probe comprises a tubular sheath, said radiation detector being arranged to be releasably located within said tubular sheath, said tubular sheath including said at least one extendable member.

43. The instrument of claim 42 wherein said tubular sheath comprises a disposable material.

44. The instrument of claim 35 additionally comprising diathermy means for applying energy to the radioactively tagged tissue.

45. The instrument of claim 35 wherein said at least one extendable member is barbed.

46. The instrument of claim 35 wherein said probe has a longitudinal axis and wherein said at least one extendable member is arranged to be extended at an acute angle to said longitudinal axis.

47. The instrument of claim 46 wherein said at least one extendable number is adjustable and is arranged to be extended at an adjustable angle to said longitudinal axis.

48. The instrument of claim 35 additionally comprising means for introducing a biologically active material adjacent the radioactively tagged lymph node.

49. The instrument of claim 35 wherein said radiation detector has a solid angle of acceptance of radiation and wherein said instrument comprises a collimator for establishing the solid angle of acceptance of said radiation detector to radiation emanating from the radioactively tagged lymph node.

50. The instrument of claim 49 wherein said collimator is adjustable to adjust said solid angle of acceptance.

51. The instrument of claim 50 wherein said adjustable collimator includes at least one movable member arranged to be moved from a first position establishing a first, solid angle of acceptance of said radiation detector, to a second position establishing a second and narrower solid angle of acceptance of said radiation detector.

52. The instrument of claim 35 wherein said radiation detector comprises a crystal and where said instrument additionally comprises a backshielding member located proximally of said crystal to block radiation from the proximal direction to said crystal.

53. The instrument of claim 52 wherein said backshielding member comprises a lightpipe.

54. The instrument of claim 53 wherein said lightpipe comprises a material selected from the group consisting of undoped Gadolineum Orthosilicate, undoped Bismuth Germinate, undoped Cesium Iodide, and lead-glass.

55. The instrument of claim 54 additionally comprising an optical interface and wherein said lightpipe is connected to said crystal via said optical interface, said optical interface comprising either an optical coupling gel or adhesive.

56. The instrument of claim 54 wherein said crystal and said lightpipe are an integral unit comprising a material selected from the group consisting of undoped Gadolineum Orthosilicate, undoped Bismuth Germinate, undoped Cesium Iodide, and wherein said crystal comprises a scintillation doped portion of said material.

57. A method of removing a lymph node tagged with a radioactive agent from the body of a living being, the lymph node having radiation emanating therefrom, said method comprising the steps of:

(a) providing a probe device having a radiation detector and at least one, thin elongated extendable member,

(b) introducing said device within the body of the being for detecting radiation emanating from said radioactively tagged lymph node by said radiation detector,

(c) positioning said probe device so that said radiation detector is located adjacent the radioactively tagged lymph node,

(d) operating said probe device to cause said at least one extendable member to ensnare the radioactively tagged lymph node, and

(e) removing said probe device and the snared lymph node as a unit from the being'"'"'s body so as to cause minimal disruption of the tagged lymph node.

58. The method of claim 57 additionally comprising the step of providing suction adjacent said radioactively tagged lymph node.

59. The method of claim 57 additionally comprising the step of introducing a flowable material adjacent the radioactively tagged lymph node.

60. The method of claim 57 additionally comprising the step of introducing a biologically active material adjacent the radioactively tagged lymph node.

61. The method of claim 57 wherein said probe device includes a body portion, and wherein said at least one extendable member is arranged to be held in a retracted position with respect to said body portion of said probe device, and wherein said method comprises extending said at least one extendable member from said retracted position to an extended position to pierce and snare the radioactively tagged lymph node.

62. The method of claim 61 wherein said extendable member is extended to pierce into the radioactively tagged lymph node.

63. The method of claim 62 additionally comprising the step of providing energy to the radioactively tagged lymph node.

64. The method of claim 63 wherein said energy is applied by diathermy means forming a portion of said probe device.

65. The method of claim 57 wherein said lymph node is a sentinel node.