Tissue specimen encapsulation device and method thereof

• US 6,344,026 B1
• Filed: 12/09/1998
• Issued: 02/05/2002
• Est. Priority Date: 04/08/1998
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Jones, Michael L., Burbank, Fred H., Quick, Richard L., Lubock, Paul, Louw, Jacob Frank
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/208,535
• Time in Patent Office: 1,154 Days
• Field of Search: 600/562, 600/564-567, 606/113, 606/114
• US Class Current: 600/567
• 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 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2090/3908 : Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

A device for encapsulating tissue specimens includes a wand assembly, a sheath, and a guide assembly. The guide assembly pulls, draws, or otherwise moves the sheath about the tissue specimen. The wand assembly is disposed proximate to the tissue specimen, typically either adjacent or through the specimen. In an aspect of the encapsulating device, the guide assembly has sheath deployment members that are disposed about the tissue specimen. The sheath, which is attached to ends of the sheath deployment members and the wand assembly, is drawn over the tissue specimen as the sheath deployment members are pushed or pulled. In another aspect of the device, the guide assembly is an arm or a housing that rotates about the tissue specimen. The sheath, which is secured at one end to the guide assembly and at another end to the wand assembly, is drawn over the tissue specimen as the guide assembly rotates. The sheath may be made up of porous material, non-porous material, selectively permeable material, woven material, braided material, knit material, web material, mesh material, a film material, a flexible laminate material, or of an elastic material.

Claims

1. A device for encapsulating a tissue specimen prior to withdrawal from a body, comprising:

a. an elongated wand assembly having a longitudinal axis, an inner lumen extending therein;

b. a tissue encapsulating sheath comprising a proximal portion connected to the wand assembly and a distal portion; and

c. an elongated guide assembly which is slidably disposed within the wand assembly, which has a plurality of sheath deploying members configured to be disposed about a tissue specimen and having proximal and distal ends with the proximal ends connected to the distal portion of the sheath and a pull member secured to the distal ends of the sheath deploying members so that tension on the pull member will pull the sheath deploying members and thereby pull the sheath about at least a portion of the tissue specimen.

2. The encapsulating device of claim 1, wherein the sheath comprises a plurality of non-contiguous segments.

3. The encapsulating device of claim 2, wherein adjacent non-contiguous segments overlap when the sheath is positioned about at least a portion of the tissue specimen.

4. The encapsulating device of claim 1, wherein the tissue specimen is generally cylindrical.

5. The encapsulating device of claim 1, wherein the guide assembly is capable of moving the sheath second portion in a direction that is not the axial direction.

6. The encapsulating device of claim 1, wherein the guide assembly is capable of moving rotationally the sheath second portion about the tissue specimen.

7. The encapsulating device of claim 6, wherein the guide assembly is capable of moving rotationally the sheath second portion about an axis of rotation that is parallel to the wand assembly axis.

8. The encapsulating device of claim 6, wherein the guide assembly is capable of moving rotationally the sheath second portion about an axis of rotation that is generally co-existent with the wand assembly axis.

9. The encapsulating device of claim 6, wherein the guide assembly comprises a wrapper assembly having a housing in which is disposed the sheath second portion and a tissue covering portion of the sheath, wherein the wrapper assembly is capable of moving about at least a portion of the tissue specimen while depositing the sheath tissue covering portion thereon.

10. The encapsulating device of claim 9, wherein the sheath tissue covering portion is disposed in the housing in a rolled arrangement.

11. The encapsulating device of claim 9, wherein the sheath tissue covering portion is disposed in the housing in a folded arrangement.

12. The encapsulating device of claim 9, wherein:

a. the wand assembly comprises a shaft having a distal end, a proximal end, and a midportion therebetween; and

b. the wrapper assembly comprises a first end attached to the shaft distal end, a second end attached to the shaft midportion, with the housing extending between wrapper assembly ends.

13. The encapsulating device of claim 9, wherein the housing comprises an arc-shaped portion.

14. The encapsulating device of claim 9, wherein the wrapper assembly first and second ends radially extend from the shaft.

15. The encapsulating device of claim 9, wherein:

a. the wrapper assembly first and second ends perpendicularly extend from the shaft; and

b. the housing is generally straight.

16. The encapsulating device of claim 9, wherein the sheath first portion extends along the shaft and generally between the wrapper assembly first end and the wrapper assembly second end.

17. The encapsulating device of claim 9, wherein the tissue specimen is disposed adjacent to the shaft and between the shaft midportion and distal end.

18. The encapsulating device of claim 9, wherein the tissue specimen is disposed about the shaft and between the shaft midportion and distal end.

19. The encapsulating device of claim 6, wherein the guide assembly comprises an arm that is attached to the sheath second portion, the arm being capable of moving about at least a portion of the tissue specimen.

20. The encapsulating device of claim 19, wherein:

a. the wand assembly comprises a shaft having a distal end, a proximal end, a midportion, and an outside surface;

b. the arm comprises a first end attached to the shaft distal end and a second end attached to the shaft midportion;

c. the sheath first portion is between the arm first end and the arm second end.

21. The encapsulating device of claim 19, wherein the arm is arc-shaped.

22. The encapsulating device of claim 19, wherein the arm has two ends that radially extend from the shaft.

23. The encapsulating device of claim 19, wherein the arm has two ends that radially extend from the shaft and a connecting portion extending generally straight between the two ends.

24. The encapsulating device of claim 19, wherein the arm has two ends that perpendicularly extend from the shaft.

25. The encapsulating device of claim 19, wherein the sheath first portion generally extends between the arm first end and the arm second end.

26. The encapsulating device of claim 19, wherein:

a. the shaft is hollow; and

b. the sheath first portion is disposed in the shaft.

27. The encapsulating device of claim 26, wherein a stored portion of the sheath is stored in the shaft in a rolled arrangement.

28. The encapsulating device of claim 26, wherein a stored portion of the sheath is stored in the shaft in a folded arrangement.

29. The encapsulating device of claim 19, wherein the tissue specimen is disposed proximate to the wand assembly.

30. The encapsulating device of claim 29, wherein the tissue specimen is disposed about the wand assembly.

31. The encapsulating device of claim 29, wherein the tissue specimen is disposed adjacent the wand assembly.

32. The encapsulating device of claim 1, wherein the sheath is comprised of porous material.

33. The encapsulating device of claim 1, wherein the sheath is comprised of non-porous material.

34. The encapsulating device of claim 1, wherein the sheath is comprised of selectively permeable material.

35. The encapsulating device of claim 1, wherein the sheath is comprised of woven material.

36. The encapsulating device of claim 1, wherein the sheath is comprised of braided material.

37. The encapsulating device of claim 1, wherein the sheath is comprised of a knit material.

38. The encapsulating device of claim 1, wherein the sheath is comprised of a web material.

39. The encapsulating device of claim 1, wherein the sheath is comprised of a mesh material.

40. The encapsulating device of claim 1, wherein the sheath is comprised of a film material.

41. The encapsulating device of claim 1, wherein the sheath is comprised of a flexible laminate material.

42. The encapsulating device of claim 1, wherein the sheath is comprised of an elastic material.

43. The encapsulating device of claim 1, wherein the guide assembly is capable of rotationally moving the sheath second portion about the tissue specimen and about an axis of rotation that is parallel to the wand assembly axis.

44. The encapsulating device of claim 1, wherein the guide assembly is capable of rotationally moving the sheath second portion about the tissue specimen and about the wand assembly axial direction.

45. The encapsulating device of claim 1, further comprising an actuator device functionally connected to the encapsulating device, the actuator device being arranged to manipulate at least one of the components of the encapsulating device.

46. The encapsulating device of claim 1, further comprising a tissue cutting device that is attached to the wand assembly and arranged such that the tissue cutting device enlarges a passage for the encapsulated tissue specimen to travel through to exit the body.

47. The encapsulating device of claim 1, further comprising a tissue cutting device comprising a cutting member with a first end that is attached to a midportion of the wand assembly and a second end that is attached to a distal end of the wand assembly, wherein the cutting member extends radially from the wand assembly.

48. The encapsulating device of claim 47, wherein the cutting member is connected in an electrical conducting relationship to a radio frequency generator.

49. The encapsulating device of claim 1, further comprising a tissue cutting device comprising a cutting member that extends radially from the wand assembly.

50. The encapsulating device of claim 49, wherein the cutting member is connected in an electrical conducting relationship to a radio frequency generator.

51. The encapsulating device of claim 1, wherein the wand assembly is rigid.

52. The encapsulating device of claim 1, wherein the wand assembly is flexible.

53. The encapsulating device of claim 1, wherein the wand assembly is articulatable to enable the wand assembly to be steered.

54. A method of sheathing a tissue specimen comprising the steps of

a. disposing an encapsulation device proximate to the tissue specimen, the encapsulating device comprising:

i. a wand assembly defining an axial direction and a radial direction;

ii. a sheath comprising a proximal portion being connected to the wand assembly and a distal portion; and

iii. a guide assembly attached to the distal portion of the sheath, wherein the guide assembly is capable of positioning the sheath about at least a portion of the tissue specimen; and

b. positioning the sheath about at least a portion of the tissue specimen portion by manipulating the guide assembly.

55. The method of claim 54, wherein the disposing step comprises the step of inserting a distal end of the wand assembly through the tissue specimen.

56. The method of claim 54, wherein the disposing step comprises the step of placing a distal end of the wand assembly adjacent the tissue specimen.

57. The method of claim 54, wherein the positioning step comprises the step of directing the second portion over the tissue specimen in the axial direction.

58. The method of claim 54, wherein the positioning step comprises the step of directing the second portion over the tissue specimen in a rotational direction.

59. The method of claim 58, wherein an axis of the rotational direction is parallel to the axial direction.

60. The method of claim 57, wherein the positioning step comprises the step of directing the guide assembly to move from a linear, axial position adjacent the wand assembly, through a gap extending radially and axially to an outer surface of the tissue specimen, and over a portion of the tissue specimen outer surface.

61. The method of claim 54, wherein the positioning step comprises the step of positioning the sheath about the entire tissue specimen.

62. The method of claim 54, wherein the positioning step comprises the step of positioning the sheath about at least a portion of the tissue specimen.

63. The method of claim 62, wherein the positioning the sheath step further comprises the step of drawing the second portion of the sheath through a periphery margin about the tissue specimen.

64. The method of claim 54, wherein the disposing step comprises the step of inserting the wand assembly into an insufflated region of the body.

65. The method of claim 54, wherein the disposing step comprises the step of inserting the wand assembly into a non-insufflated region of the body.

66. The method of claim 54, further comprising the step of withdrawing the wand assembly and the tissue specimen from the body.

67. The method of claim 66, wherein the withdrawing step comprises the step of enlarging a passage in the body through which the encapsulation device extends to facilitate removal of the tissue specimen from the body.

68. The method of claim 67, wherein the enlarging the passage step comprises surgically expanding the passage.

69. The method of claim 68, wherein the surgically expanding the passage step comprises radially extending a cutting device from the wand assembly.

70. The method of claim 68, wherein the surgically expanding the passage step comprises energizing a member of the guide assembly with a radio frequency generator and expanding the passage with the radio frequency energized guide assembly member.

71. The method of claim 54, wherein the disposing step further comprises the step of steering the wand assembly to the tissue specimen, wherein the wand assembly is articulatable.

72. A device for retrieving a tissue specimen from a patient'"'"'s body, comprising:

a. an elongated shaft having proximal and distal end;

b. an active electrode on the distal end for entering the body; and

c. an encapsulation assembly comprising a plurality of axially disposed bands expandable in a radial direction for at least partially covering a tissue specimen with an encapsulating sheath prior to retrieving the tissue specimen from the body.

73. The retrieving device of claim 72, wherein:

a. the bands have a distal end attached to a distal end of the retrieving device;

b. the bands have a proximal end attached to a midportion of the retrieving device; and

c. the retrieving device distal end is rotatable about the axis compared to the retrieving device midportion in order that the bands may be twisted about the tissue specimen.

74. The retrieving device of claim 72, further comprising a flexible sheet spanning between at least two of the bands.

75. The retrieving device of claim 74, wherein the flexible sheet is a web.

76. A device for encapsulating a tissue specimen prior to withdrawal from a patient'"'"'s body, comprising:

a. an elongated wand assembly having an outer sleeve, and inner tubular shaft disposed within the outer sleeve, an inner lumen extending within the inner tubular shaft and a sheath sleeve disposed between the outer sleeve and the inner tubular shaft;

b. a tissue encapsulating sheath comprising a proximal sheath portion connected to a distal extremity of the sheath sleeve and a distal sheath portion; and

c. an elongated guide assembly which is at least in part slidably disposed within the inner lumen of the inner tubular shaft of the wand assembly, which has a plurality of elongated sheath deploying members having proximal and distal ends with the proximal ends of the elongated sheath deploying members connected to the distal portion of the sheath and a pull member having proximal and distal ends with the distal end of the pull member secured to the distal ends of the sheath deploying members so that when tension is applied to the proximal end of the pull member the pull member will pull the sheath deploying members into the inner lumen of the inner tubular shaft and thereby pull the sheath about at least a portion of the tissue specimen.

77. The encapsulating device of claim 76 wherein the inner tubular shaft has an inner tubular core member having proximal and distal ends and an inner lumen extending therein with the pull member slidably disposed within the inner lumen of the inner tubular core member.

78. The encapsulating device of claim 77 wherein push rods are slidably mounted onto the exterior of the inner tubular core member and have distal ends which are secured to the proximal ends of the sheath deploying members.

79. A device for retrieving a tissue specimen from a patient'"'"'s body, comprising:

a. an elongated shaft having a proximal and a distal end;

b. an expandable cutting member on a distal portion of the elongated shaft for cutting a tissue specimen from supporting tissue; and

c. an encapsulation assembly for at least partially covering the tissue specimen with an encapsulating sheath prior to retrieving the tissue specimen from the body, the sheath comprising a plurality of axially disposed bands expandable in a radial direction.

80. The retrieving device of claim 79, wherein:

a. the bands have distal ends attached to a distal end of the retrieving device; and

b. the bands have proximal ends attached to the encapsulating sheath.

81. The retrieving device of claim 80 wherein a flexible sheet spans between at least two of the bands.

82. The retrieving device of claim 81, wherein the flexible sheet is a web.