Devices and methods for performing procedures on a breast

• US 7,438,693 B2
• Filed: 06/06/2005
• Issued: 10/21/2008
• 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: Vetter, James W., Anderson, Scott C., Brounstein, Daniel M., Tuttle, Jordon S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/145,808
• Publication Number:
  US 20050222521A1
• Time in Patent Office: 1,233 Days
• Field of Search: 600564-567, 606/116, 606/139, 606/159, 606/185, 606/167, 606/170, 606/114, 606/180
• 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 distal portion, a proximal portion and at least one radially movable indicator at the proximal portion for indicating a radial angular orientation when viewed along a longitudinal axis of the needle;

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

radially moving the indicator to a radial position which provides an indication of a selected radial angular orientation relative to the longitudinal axis; and

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

2. The method of claim 1, wherein:

the performing step includes removing breast tissue.

3. The method of claim 1, wherein:

the moving step is carried out to move the indicator to a position which angularly bounds a tissue area to be removed from the breast.

4. The method of claim 1, wherein:

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

5. The method of claim 1, wherein:

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

6. The method of claim 4, wherein:

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

7. The method of claim 5, 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.

8. The method of claim 1, wherein:

the moving step is carried out by selecting at least two different angular positions when viewed along the longitudinal axis of the needle.

9. The method of claim 1, wherein:

the moving step is carried out at least two times to indicate two different angular orientations relative to the longitudinal axis.

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

an elongate shaft having a longitudinal axis, a distal portion configured to be positioned within the patient'"'"'s breast and a proximal portion configured to remain outside the patient'"'"'s breast; and

a first indicator at the proximal portion for indicating an angular orientation when viewed along the longitudinal axis of the shaft, the first indicator being radially movable by a user to a selected radial angular orientation relative to the longitudinal axis of the shaft.

11. The needle of claim 10, wherein:

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

12. The needle of claim 10, 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.

13. The needle of claim 12, wherein:

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

14. The needle of claim 12, wherein:

the anchoring element is a wire.

15. The needle of claim 14, wherein:

the wire extending through a slot in the shaft.

16. The needle of claim 10, further comprising:

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

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

providing a guide element having a distal portion, a proximal portion and a cutting device, the guide element having at least one radially movable indicator at the proximal portion for indicating a radial angular orientation with respect to a longitudinal axis of the guide element, the cutting device having a deployable cutting element mounted on the shaft;

introducing the distal portion of the guide element into a patient'"'"'s breast with the proximal portion remaining outside the 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;

rotating the shaft so that the cutting element severs breast tissue; and

removing the breast tissue which has been severed by the cutting element.

18. The method of claim 17, wherein:

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

19. The method of claim 17, wherein:

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

20. The method of claim 17, wherein:

the rotating step is carried out using the angular orientation indicated by the at least one indicator.

21. The method of claim 17, wherein:

the rotating step is carried out with at least two angular orientations indicated on the guide element at least one of which being selected by a user.

22. The method of claim 17, wherein:

the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.

23. The method of claim 22, wherein:

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

24. A system for removing breast tissue, comprising:

a guide element, the guide element having a distal portion configured to be positioned within a patient'"'"'s breast, a proximal portion configured to remain outside the patient'"'"'s breast and a first radially movable indicator at the proximal portion for indicating an angular orientation with respect to a longitudinal axis of the guide element; and

a cutting device coupled to the distal portion, the cutting device having a deployable cutting element mounted on a shaft, the cutting device being configured to be slidably coupled to the guide element.

25. The system of claim 24, wherein:

the guide element is a needle.

26. The system of claim 24, wherein:

the guide element has a second indicator for indicating an angular orientation with respect to the longitudinal axis of the guide element.

27. The system of claim 24, wherein:

the cutting element being deployed by bowing an elongate cutting element, the cutting element being coupled to a source of RF energy.

28. The system of claim 27, further comprising:

a tissue collection element carried by the cutting device, the tissue collection element surrounding the severed tissue.

29. The system of claim 28, wherein:

the collection element is a bag which surrounds the severed tissue.

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

providing a guide element and a cutting device, the guide element having at least one radially movable indicator at a proximal end thereof for indicating a radial angular orientation with respect to a longitudinal axis of the guide element, the cutting device having a deployable cutting element mounted on a shaft;

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;

rotating the shaft less than 180 degrees relative to the guide element so that the cutting element severs breast tissue; and

removing the breast tissue which has been severed by the cutting element.

31. The method of claim 30, wherein:

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

32. The method of claim 30, wherein:

the rotating step is carried out using the angular orientation indicated by the at least one indicator.

33. The method of claim 30, wherein:

the rotating step is carried out with at least two angular orientations indicated on the guide element at least one of which being selected by a user.

34. The method of claim 30, wherein:

the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.

35. The method of claim 34, wherein:

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

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

providing a guide element and a cutting device, the guide element having at least one radially movable indicator at a proximal end thereof for indicating a radial angular orientation with respect to a longitudinal axis of the guide element, the cutting device having a deployable cutting element mounted on a shaft;

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;

rotating the shaft, using the angular orientation indicated by the at least one indicator, so that the cutting element severs breast tissue; and

removing the breast tissue which has been severed by the cutting element.

37. The method of claim 36, wherein:

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

38. The method of claim 36, wherein:

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

39. The method of claim 36, wherein:

the rotating step is carried out with at least two angular orientations indicated on the guide element at least one of which being selected by a user.

40. The method of claim 36, wherein:

the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.

41. The method of claim 40, wherein:

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

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

providing a guide element and a cutting device, the guide element having at least one radially movable indicator at a proximal end thereof for indicating a radial angular orientation with respect to a longitudinal axis of the guide element, the cutting device having a deployable cutting element mounted on a shaft;

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;

rotating the shaft, with at least two angular orientations indicated on the guide element at least one of which being selected by the a user, so that the cutting element severs breast tissue; and

removing the breast tissue which has been severed by the cutting element.

43. The method of claim 42, wherein:

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

44. The method of claim 42, wherein:

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

45. The method of claim 42, wherein:

the rotating step is carried out using the angular orientation indicated by the at least one indicator.

46. The method of claim 42, wherein:

the removing step is carried out with the severed breast tissue being contained in a collection element carried by the cutting device.

47. The method of claim 46, wherein:

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