Devices and methods for performing procedures on a breast

• US 6,936,014 B2
• Filed: 10/16/2002
• Issued: 08/30/2005
• Est. Priority Date: 10/16/2002
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Tuttle, Jordan S., Vetter, James W., Anderson, Scott C., Brounstein, Daniel M.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/272,448
• Publication Number:
  US 20040077971A1
• Time in Patent Office: 1,049 Days
• Field of Search: 600/564, 600/567, 600/585, 600/434, 606/114, 606/170, 606/116, 606/50, 606/41, 606/45, 607/101, 128/899
• US Class Current: 600/564
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A needle is used to mark a tissue area of interest. The needle may have one or more indicators which indicate selected angular orientations relative to the needle. The indicators may also be coupled to anchors which are deployed in the tissue to anchor the needle in the tissue. The needle may be positioned to guide an excisional device to remove tissue.

Claims

1. A method of positioning a needle in a patient'"'"'s breast for a medical procedure, comprising the steps of:

providing a needle having a proximal portion and a distal portion, the proximal portion being movable between a rigid condition and a flexible condition which may be selected by a user;

positioning the distal portion in a patient'"'"'s breast with the proximal portion remaining outside the breast, the distal portion being in the rigid condition for facilitating introduction into the patient'"'"'s breast;

changing the proximal portion from the rigid condition to the flexible condition after the positioning step; and

performing a medical procedure on the patient'"'"'s breast.

2. The method of claim 1, wherein:

the performing step includes the step of removing breast tissue.

3. The method of claim 2, wherein:

the performing step is carried out by removing tissue not penetrated by the needle.

4. The method of claim 1, further comprising the step of:

creating another rigid condition at the proximal portion after the changing step and before the performing step.

5. The method of claim 1, wherein:

the changing step is carried out by removing a stiffener from the proximal portion of the needle.

6. The method of claim 1, wherein:

the performing step is carried out by guiding a cutting device into the patient using the needle to guide the cutting device.

7. The method of claim 1, wherein:

the performing step is carried out with a tissue removal device being guided by the needle and the medical procedure being a tissue removal procedure.

8. The method of claim 7, wherein:

the performing step is carried ant with the tissue removal device rotating to move a cutting element along an arc within the tissue.

9. The method of claim 7, wherein:

the performing step is carried out with the tissue removal device being rotationally constrained by the needle at a first location.

10. The method of claim 9, wherein:

the performing step is carried out with the first location coinciding with a first angular indicator which indicates an angular position with respect to a longitudinal axis of the needle to the user.

11. The method of claim 7, wherein:

the performing step is carried out with the tissue removal device having a cutting element which moves between bowed and retracted positions, the cutting element being in a bowed position while cutting tissue.

12. The method of claim 7, wherein:

the performing step is carried out with the tissue removal device engaging a stop on the needle which prevents farther longitudinal movement of the tissue removal device.

13. The method of claim 12, wherein:

the performing step is carried out with the stop positioning the tissue removal device in a predetermined longitudinal position.

14. The method of claim 1, further comprising the step of:

moving an indicator on the needle, the indicator being moved to a position which indicates an angular position with respect to a longitudinal axis of the needle.

15. The method of claim 14, wherein:

the moving step is carried out with the position of the indicator providing an angular bound of tissue to be removed from the breast.

16. A needle for marking a patient'"'"'s breast when performing a medical procedure on the patient, comprising:

a distal portion having an elongate, rigid shaft; and

a proximal portion coupled to the distal portion, the proximal portion being selectively movable between a rigid condition and a flexible condition, wherein the proximal portion is in the rigid condition during introduction into a patient'"'"'s breast and is movable to the flexible condition after introduction into the breast.

17. The needle of claim 16, wherein:

the proximal portion has a removable stiffener.

18. The needle of claim 16, further comprising:

an indicator which is movable to a selected angular orientation relative to a longitudinal axis.

19. The needle of claim 16, wherein:

the needle has a longitudinal stop which prevents further longitudinal movement of a tissue removal device, the stop being oriented to position the tissue removal device in a predetermined longitudinal position relative to the tissue be removed after positioning the needle in the breast.

20. The needle of claim 16, further comprising:

an anchoring element which is movable together with the indicator to a selected orientation relative to the longitudinal axis.

21. The needle of claim 20, wherein:

the anchoring element is a thin, elongate element which pierces the breast tissue.

22. The needle of claim 21, further comprising:

a shaft having an opening;

the element extends through the opening in the shaft.

23. The needle of claim 20, wherein:

the anchoring element is a J-shaped wire.

24. A method of positioning a needle in a patient'"'"'s breast for a medical procedure, comprising the steps of:

providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;

positioning the distal portion in a patient'"'"'s breast with the proximal portion remaining outside the breast,

moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis to move the indicator to a position which angularly bounds a tissue area to be removed from the breast, and

performing a medical procedure using information from the selected angular orientation.

25. The method of claim 24, wherein:

the performing step includes the step of removing breast tissue.

26. A method of positioning a needle in a patient'"'"'s breast for a medical procedure, comprising the steps of:

providing a needle at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion that includes at least one anchoring element and a proximal portion;

positioning the distal portion in a patient'"'"'s breast with the proximal portion remaining outside the breast,

moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis, the moving step being carried out by moving the at least one anchoring element, the at least one anchoring element being displaced angularly with respect to the longitudinal axis, and

performing a medical procedure using information from the selected angular orientation.

27. The method of claim 26, wherein:

the performing step includes the step of removing breast tissue.

28. The method of claim 26, wherein:

the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.

29. The method of claim 26, wherein:

the moving step is carried out with the at least one anchoring element being a wire.

30. The method of claim 28, wherein:

the providing step is carried out with the needle having a shaft; and

the moving step is carried out with the anchoring element extending through a slot in the shaft.

31. The method of claim 28, wherein:

the performing step includes the step of removing breast tissue.

32. A method of positioning a needle in a patient'"'"'s breast for a medical procedure, comprising the steps of:

providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;

positioning the distal portion in a patient'"'"'s breast with the proximal portion remaining outside the breast,

moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis by selecting at least two different angular positions when viewed along the longitudinal axis of the needle, and

performing a medical procedure using information from the selected angular orientation.

33. The method of claim 32, wherein:

the performing step includes the step of removing breast tissue.

34. The method of claim 32, wherein:

the providing is carried out with the needle including at least one anchoring element, and

the moving step is carried out by moving the at least one anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis during the moving step.

35. The method of claim 34, wherein:

the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.

36. The method of claim 34, wherein:

the moving step is carried out with the at least on anchoring element being a wire.

37. The method of claim 35, wherein:

the providing step is carried out with the needle having a shaft; and

the moving step is carried out with the element extending through a slot in the shaft.

38. A method of positioning a needle in a patient'"'"'s breast for a medical procedure, comprising the stops of:

providing a needle having at least one movable indicator for indicating an angular orientation when viewed along a longitudinal axis of the needle, the needle having a distal portion and a proximal portion;

positioning the distal portion in a patient'"'"'s breast with the proximal portion remaining outside the breast,

moving the indicator to a position which provides an indication of a selected angular orientation relative to the longitudinal axis and repeating the moving step at least once to indicate two different angular orientations relative to the longitudinal axis, and

performing a medical procedure using information from the selected angular orientation.

39. The method of claim 38, wherein:

the providing is carried out with the needle including at least one anchoring element, and

the moving step is carried out by moving the at least one anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis during the moving step.

40. The method of claim 39, wherein:

the moving step is carried out with the at least one anchoring element being a thin, elongate element which pierces the breast tissue.

41. The method of claim 39, wherein:

the moving step is carried out with the at least on anchoring element being a wire.

42. The method of claim 40, wherein:

the providing step is carried out with the needle having a shaft; and

the moving step is carried out with the element extending through a slot in the shaft.

43. A needle for introduction into a patient'"'"'s breast, comprising:

an elongate shaft having a longitudinal axis; and

a first indicator for indicating an angular orientation when viewed along the longitudinal axis of the shaft, the first indicator being movable by the user to a selected angular orientation and being coupled to an anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis when the first indicator is moved by the user.

44. The needle of claim 43, wherein:

the first indicator is moved to a position to provide angular information regarding a tissue area to be removed from the breast.

45. The needle of claim 43, wherein:

the anchoring element is a thin, elongate element which pierces the breast tissue.

46. The needle of claim 43, wherein:

the anchoring element is a wire.

47. The needle of claim 46, wherein:

the wire extending through a slot in the shaft.

48. A needle for introduction into a patient'"'"'s breast, comprising:

an elongate shaft having a longitudinal axis;

a first indicator for indicating an angular orientation when viewed along the longitudinal axis of the shaft, the first indicator being movable by the user to a selected angular orientation, and

a second indicator for indicating another angular orientation when viewed along the longitudinal axis of the shaft.

49. The needle of claim 48, wherein:

the first and second indicators are moved to positions to provide angular information regarding a tissue area to be removed from the breast.

50. The needle of claim 48, wherein:

the first indicator is coupled to an anchoring element, the anchoring element being displaced angularly with respect to the longitudinal axis when the first indicator is moved by the user.

51. The needle of claim 50, wherein:

the anchoring element is a thin, elongate element which pierces the breast tissue.

52. The needle of claim 50, wherein:

the anchoring element is a wire.

53. The needle of claim 52, wherein:

the wire extending through a slot in the shaft.

54. A method of excising breast tissue, comprising the steps of:

providing a guide element and a cutting device, the cutting device having a deployable cutting element mounted on a shaft, the cutting device also having a tissue collection element;

introducing the guide element into a patient'"'"'s breast;

advancing the cutting device into the patient'"'"'s breast, the cutting device being slidably coupled to the guide element so that the guide element guides the cutting device as the cutting device is advanced into the patient'"'"'s breast;

deploying a cutting element on the cutting device after the advancing step, the cutting element moving from a collapsed position to an expanded position, the cutting element bowing outwardly from the shaft when being deployed;

rotating the shaft so that the cutting element severs breast tissue, the severed breast tissue entering the tissue collection element which trails the cutting element as the cutting element moves through the breast tissue when the shaft is rotated; and

removing the breast tissue which has been severed by the cutting element and is contained within the tissue collection element.

55. The method of claim 54, wherein:

the providing step is carried out with the guide element being a needle; and

the advancing step being carried out with the cutting device being advanced over the needle.

56. The method of claim 54, wherein:

the rotating step is carried out with the shaft rotating less than 180 degrees relative to the guide element.

57. The method of claim 54, wherein:

the providing step is carried out with the guide element having an indicator for a desired depth of penetration of the cutting device during the advancing step.

58. The method of claim 54, wherein:

the removing step is carried out with the tissue collection element surrounding and isolating the severed tissue from the surrounding tissue.