Minimally invasive surgical instrument for tissue identification, dislodgment and retrieval and methods of use

• US 6,484,050 B1
• Filed: 11/30/1998
• Issued: 11/19/2002
• 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: Wise, Robin A. Jr., Carroll, Robert G.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/201,289
• Time in Patent Office: 1,450 Days
• Field of Search: 600/436, 600/431, 600/204, 600/207, 600/562, 606/190, 606/192, 606/194, 606/186, 606/167, 606/185, 604/96.01, 604/27, 604/103.1, 604/28, 604/48, 250/370.12, 250/362, 250/363.02, 250/336.1
• 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: A61B 6/506 for diagnosis of nerves
• 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 or sheath for use on a probe for detecting and removing radioactively tagged tissue, e.g., a sentinel lymph node, within the body of a living being. The probe or sheath and 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 it can be positioned immediately adjacent that tissue to ensnare or trap that tissue. The probe or sheath and 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. A blunt dissecting device is provided as part of the sheath or as part of the probe itself to aid in separating the tagged tissue from adjacent tissue without injury to the adjacent tissue. The probe may be a fully integrated, self-powered unit.

Claims

1. An instrument for minimally invasive introduction within the body of a living being including a probe and a blunt tissue dissector, said probe including a radiation detector for detecting radiation emanating from radioactively tagged tissue within the being'"'"'s body to determine the location of the radioactively tagged tissue to enable the instrument to be moved adjacent to the radioactively tagged tissue, said tissue dissector being arranged to bluntly separate the radioactively tagged tissue from adjacent tissue so that the radioactively tagged tissue may be readily removed from the being'"'"'s body.

2. The instrument of claim 1 wherein said blunt tissue dissector includes an inflatable balloon.

3. The instrument of claim 2 wherein said instrument includes a grabbing member for grabbing the radioactively tagged tissue.

4. The instrument of claim 3 wherein said grabbing member includes at least one extendable member to ensnare the radioactively tagged tissue.

5. The instrument of claim 4 wherein said at least one extendable member is arranged to pierce into the radioactively tagged tissue.

6. The instrument of claim 3 wherein said grabbing member includes plural extendable members to engage the radioactively tagged tissue from plural directions to ensnare it.

7. The instrument of claim 3 wherein said probe comprises a body member formed of a radiation blocking material and having radiation detecting means 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.

8. The instrument of claim 7 wherein said blunt tissue dissector is located at said distal end portion of said body member.

9. The instrument of claim 2 wherein said probe comprises a 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 balloon being extendable from said distal end portion to an extended position and being retractable from said extended position towards said distal end portion to ensnare the radioactively tagged tissue between it and said distal end portion, thereby enabling said instrument to remove the radioactively tagged tissue from the body of the being.

10. The instrument of claim 9 wherein said balloon is mounted on an arm, said arm being coupled to said probe and being arranged to be extended from said distal end portion and retracted towards said distal end portion to carry said balloon to the position ensnaring the radioactively tagged tissue between said balloon and said distal end portion of said probe.

11. The instrument of claim 10 wherein said balloon is arranged to be inflated when said balloon is in said extended position.

12. The instrument of claim 1 wherein said instrument includes a grabbing member for grabbing the radioactively tagged tissue.

13. The instrument of claim 12 wherein said grabbing member includes at least one extendable member to ensnare the radioactively tagged tissue.

14. The instrument of claim 13 wherein said at least one extendable member is arranged to pierce into the radioactively tagged tissue.

15. The instrument of claim 13 wherein said probe comprises a 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, and wherein said extendable member is arranged to be extended outward from said distal end of said probe, said extendable member including a portion curving backward toward said distal end of said probe.

16. The instrument of claim 15 wherein said instrument includes plural extendable members, each of which being arranged to be extended outward from said distal end of said probe, each of said extendable members including a portion curving backward toward said distal end of said probe.

17. The instrument of claim 12 wherein said grabbing member includes plural extendable members to engage the radioactively tagged tissue from plural directions to ensnare it.

18. The instrument of claim 17 wherein said probe includes a distal end portion and each of said extendable members includes a free end arranged to be extended from said distal end portion of said probe, and when so extended each of said members assumes an arcuate configuration so that its free end is located closely adjacent said distal end portion of said probe.

19. The instrument of claim 18 wherein said probe is an elongated member of small diameter arranged to be readily held on the hand, and wherein the radius of curvature of at least one of said extendable members is approximately equal to one-half of the diameter of the probe.

20. The instrument of claim 12 wherein said probe comprises a body member formed of a radiation blocking material and having radiation detecting means 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.

21. The instrument of claim 20 wherein said blunt tissue dissector is located at said distal end portion of said body member.

22. The instrument of claim 1 wherein said blunt tissue dissector is arranged to separate the radioactively tagged tissue from adjacent tissue along a tissue plane interface.

23. The instrument of claim 1 wherein said instrument is arranged to provide an output signal in response to the radiation detected thereby.

24. The instrument of claim 23 wherein said output signal varies based on the placement of said instrument with respect to said radioactively tagged tissue.

25. The instrument of claim 24 wherein said output signal that varies based on the placement of said instrument is in a form that is perceptible by a user of the system.

26. The instrument of claim 25 wherein said blunt tissue dissector includes an inflatable balloon.

27. The instrument of claim 1 wherein said blunt tissue dissector is arranged to carry illumination through at least a portion of it to illuminate the radioactively tagged tissue.

28. The instrument of claim 1 wherein said blunt tissue dissector is arranged to be releasably secured to said probe.

29. The instrument of claim 28 additionally comprising a grabbing member for grabbing the radioactively tagged tissue.

30. The instrument of claim 29 wherein said grabbing member is arranged to be releasably secured to said probe.

31. The instrument of claim 1 wherein said probe comprises a small diameter elongated member arranged to be readily held in the hand.

32. The instrument of claim 31 wherein said blunt tissue dissector is arranged to be releasably secured to said probe.

33. The instrument of claim 32 additionally comprising a grabbing member for grabbing the radioactively tagged tissue.

34. The instrument of claim 31 wherein said grabbing member is arranged to be releasably secured to said probe.

35. The instrument of claim 34 wherein said blunt tissue dissector and said grabbing member are combined as an integral unit arranged to be releasably mounted on said probe.

36. The instrument of claim 34 wherein said blunt tissue dissector, said grabbing member and said probe are combined as an integral unit.

37. The instrument of claim 1 additionally comprising a fluid introduction passage for providing a fluid through said instrument into the body of the being.

38. The instrument of claim 1 additionally comprising a fluid extraction passage for removing fluid from the body of the being through said instrument.

39. The instrument of claim 37 additionally comprising a fluid extraction passage for removing fluid from the body of the being through said instrument.

40. The instrument of claim 39 wherein said blunt tissue dissector is arranged to be releasably secured to said probe.

41. The instrument of claim 40 additionally comprising a grabbing member for grabbing the radioactively tagged tissue.

42. The instrument of claim 41 wherein said grabbing member is arranged to be releasably secured to said probe.

43. The instrument of claim 42 wherein said probe comprises a small diameter elongated member arranged to be readily held in the hand.

44. The instrument of claim 43 wherein said blunt tissue dissector, said grabbing member, said fluid introduction passageway, and said fluid extraction passageway are combined as an integral unit arranged to be releasably mounted on said probe.

45. The instrument of claim 44 wherein said integral unit comprises a disposable member.

46. The instrument of claim 45 wherein said disposable member comprises a sleeve arranged to be mounted on said probe.

47. A method of removing radioactively tagged tissue within a living being'"'"'s body, said method comprising the steps of:

(1) providing an instrument including a probe and a tissue dissector for minimally invasive introduction within the body of the being, said probe being arranged for detecting radiation emanating from radioactively tagged tissue within the being'"'"'s body and for providing signals indicative thereof,

(2) positioning said probe so that a predetermined portion of said probe is located adjacent the radioactively tagged tissue in response to said signals,

(3) operating said tissue dissector to bluntly separate the radioactively tagged tissue from adjacent tissue, and

(4) removing the radioactively tagged tissue from the being'"'"'s body.

48. The method of claim 47 wherein said tissue dissector includes an inflatable balloon, and wherein said method comprises inflating said balloon to effect the separation of said radioactively tagged tissue.

49. The method of claim 47 wherein said instrument includes a grabbing member for grabbing the radioactively tagged tissue radioactively tagged tissue and wherein said method comprises operating said grabbing member to grab the radioactively tagged tissue for removing said radioactively tagged tissue from the body of the being.

50. The method of claim 47 wherein said blunt dissector is arranged to engage tissue at the interface of said radioactively tagged tissue and adjacent tissue to separate the radioactively tagged tissue therefrom.

51. The method of claim 47 wherein said method of removing radioactively tagged tissue is a method of removing radioactively tagged tissue that comprises a tumor.

52. The method of claim 47 wherein said method of removing radioactively tagged tissue is a method of removing radioactively tagged tissue that comprises a lymph node.

53. The method of claim 52 wherein said method of removing radioactively tagged tissue is a method of removing a lymph node that is a sentinel node.

54. The method of claim 53 wherein the step including providing a probe having an output signal includes providing a probe having an output signal that is visible.

55. The method of claim 47 wherein said step of providing an instrument including a probe includes providing a probe having an output signal indicative of the radiation detected thereby, and wherein said method comprises guiding the positioning of said instrument in response to said output signal.

56. The method of claim 55 wherein said step including providing a probe having an output signal includes providing a probe having an output signal that is perceptible by a user of the system to effect the positioning of said instrument in response thereto.

57. The method of claim 56 wherein the step including providing a probe having an output signal includes providing a probe having an output signal that is audible.

58. The method of claim 47 additionally comprising illuminating said radioactively tagged tissue via said instrument.

59. The method of claim 47 additionally comprising introducing a fluid adjacent said radioactively tagged tissue via said instrument.

60. The method of claim 47 additionally comprising extracting a fluid from a location adjacent said radioactively tagged tissue.

61. The method of claim 60 additionally comprising introducing a fluid adjacent said radioactively tagged tissue via said instrument.

62. The method of claim 47 additionally comprising the step of providing an inflatable member via said instrument to cause hemostasis at the situs of the radioactively tagged tissue after it has been removed.