Tissue removal methods and apparatus

• US 20030109896A1
• Filed: 12/31/2002
• Published: 06/12/2003
• Est. Priority Date: 02/10/1998
• Status: Abandoned Application

• Current Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Original Assignee: Artemis Medical, Inc. (Johnson & Johnson)
• Inventors: Dubrul, William R., Curtis, Robert M., Fulton, Richard E. III
• Application Number:
  US10/334,476
• Publication Number:
  US 20030109896A1
• Time in Patent Office: Days
• US Class Current: 606/190
• 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 17/221 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 17/3421 Cannulas
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3962 palpable
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Target tissues are accessed and removed using various types of devices and methods.

Claims

1. A breast tissue removal method comprising:

positioning a tissue separation device at a target site within a patient'"'"'s breast the tissue separation device comprising a selectively energized tissue separation element;

separating a breast tissue sample by the movement of the tissue separation element through the tissue at the target site;

monitoring a factor relating to the restriction to the passage of the tissue separation element through the tissue during the separating step; and

adjusting, as needed, energy supplied to the tissue separation element based on the results of the monitoring step.

2. The method according to claim 1 wherein the positioning step is carried out percutaneously.

3. The method according to claim 1 wherein the separating step is carried out by radially expanding a wire-type tissue separation element from a support shaft and then rotating the support shaft about the support shaft axis.

4. The method according to claim 1 wherein the monitoring step monitors at least one of the following factors:

strain, pressure, force, resistance.

5. The method according to claim 1 wherein the adjusting step adjusts at least one of the following types of energy:

electrical, RF, mechanical, electromagnetic.

6. The method according to claim 1 wherein the monitoring step comprises manually monitoring said factor using tactile feedback to the user.

7. A breast tissue removal assembly comprising:

an elongate tissue separation device comprising a tissue separation element mounted to a support;

the tissue separation element movable from a retracted state to an extended state;

a tissue separation element driver operably coupled to the tissue separation element to permit the tissue separation element separate a target tissue mass from a patient, the tissue separation element driver comprising an energy source coupled to the tissue separation device;

a sensor, operably coupled to at least one of the tissue separation device and the tissue separation element driver, which senses the physical resistance to the separation of the target tissue mass from the patient'"'"'s breast; and

a feedback device operably coupling the sensor and the tissue separation element driver so that the amount of energy supplied by the tissue separation element driver to the tissue separation element can be adjusted based on the physical restriction to the passage of the tissue separation element through the patient'"'"'s breast.

8. The assembly according to claim 7 wherein the tissue separation element comprises a wire and the energy source comprises at least one of the following energy sources supplying energy to the wire:

electrical, RF, vibrational.

9. The assembly according to claim 7 wherein the tissue separation driver further comprises a user-graspable handle at a proximal end of the support.

10. The assembly according to claim 7 wherein the support comprises an elongate support shaft having proximal and distal ends, the tissue separation element mounted to said distal end.

11. A method for the percutaneous removal of tissue from a target site within a continuous tissue mass of a patient comprising:

passing a hollow, radially expandable/collapsible portion of an elongate member along a tissue track within a continuous tissue mass of a patient, extending from an access site in a patient'"'"'s skin to a target site in the patient, with the portion in a radially collapsed condition;

positioning the portion at a chosen position relative to the target site;

placing the portion in compression thereby radially expanding at least a part of the portion;

taking a tissue sample from the target site and housing said tissue sample within the portion;

removing the tissue sample from the patient while maintaining the tissue sample within the elongate member;

placing the portion in tension the thereby at least partially collapsing the part of the portion; and

removing the at least partially collapsed portion from the patient.

12. The method according to claim 11 wherein the passing step is carried out using a collapsible tube.

13. The method according to claim 11 wherein the tissue sample removing step takes place simultaneously with the portion removing step.

14. The method according to claim 11 wherein the tissue sample removing step takes place prior to the portion removing step.

15. The method according to claim 11 wherein the tension placing step:

takes place with the tissue sample housed within the portion; and

acts to radially compress the tissue sample prior to the removing step.

16. A percutaneous tissue sample removal assembly comprising:

an elongate member, at least a distal portion thereof being a radially expandable/collapsible, said distal portion having an open interior and an open distal end;

a distal portion expanding/collapsing device comprising a tubular mesh device which radially contracts when placed in tension and radially expands when placed in compression; and

a tissue sample retrieval device operable to position a tissue sample through the open distal end and into the open interior.

17. The assembly according to claim 16 wherein the entire elongate member is radially expandable/collapsible.

18. A percutaneous tissue mass retrieval assembly comprising:

a shaft having a distal end;

a radially expandable blocking element at the distal end of the shaft;

a suspect tissue mass enveloping device located proximal of the blocking element;

said tissue mass enveloping device movable from an enlarged, tissue mass-surrounding state to a contracted, tissue mass-constricting state so to enable said tissue mass to be removed from a target site with a reduced lateral size.

19. The assembly according to claim 18 further comprising:

an introducer sheath, said shaft being movable within the sheath and the enveloping device extendable from the introducer sheath towards the blocking element.

20. The assembly according to claim 18 wherein the enveloping device comprises an open-ended, axially compressible/radially expandable tubular braided element.

21. A method for maintaining access to a void within a breast of a patient, comprising:

creating a tissue void within a breast of a patient by the removal of target material from a continuous tissue mass at a target site, and through a tissue track extending from the target site and out an access site in the patient'"'"'s skin; and

placing an access sleeve along the tissue track, whereby access to the void is maintained.

22. The method according to claim 21 wherein the creating step comprises removal of a biopsy specimen.

23. The method according to claim 21 wherein the creating step comprises removal of an entire suspect tissue mass.

24. A device for removing target material from a patient comprising:

a shaft having a proximal portion, a distal portion and an axis; and

first and second axially spaced-apart, radially expandable elements carried by the distal portion of the shaft, the expandable elements being remotely selectively movable between radially retracted and radially expanded states;

the radially expandable elements being sufficiently hard and sufficiently large so to be detectable by palpation;

whereby said radially expandable elements can be used to bracket target material so the target material can be removed from a patient along with the device.

25. The device according to claim 24 wherein the radially expandable elements are generally disk-shaped when in the radially expanded state.

26. The device according to claim 24 wherein the shaft comprises first and second independently movable shafts passing through a sheath.

27. The device according to claim 24 configured for percutaneous use.

28. A method for percutaneously locating a target mass within a patient comprising:

extending the distal end of a shaft to a position distal of a target mass;

independently positioning first and second radially expanding bracketing elements at positions distal of and proximal of the target mass;

moving the bracketing elements from radially retracted states to radially expanded states thereby bracketing the target mass; and

locating the target mass using the bracketing elements.

29. A method according to claim 28 wherein the locating step is carried out by other than surgical incisional techniques.

30. The method according to claim 28 wherein the moving step is carried out so the bracketing elements define a bracketed region therebetween sized to completely contain the target mass.

31. The method according to claim 28 wherein the locating step is carried out by palpation of the bracketing elements.

32. A method for helping to prevent seeding of a tissue track with cells from the vicinity of a breast tissue target site, the tissue track defined within a continuous breast tissue mass and extending between an access site in a patient'"'"'s skin and the target site, comprising:

positioning an elongate protective device along the tissue track within the continuous breast tissue mass, the device having a wall, an opening at a distal end thereof, and an open inner region;

locating the distal end of the protective device at a position adjacent to and proximal of the target site;

moving tissue from the target site, through the opening in the device and into the inner region; and

moving the tissue along the tissue track and out of the patient while keeping the tissue within the device, the wall preventing seeding of the tissue track by the tissue.

33. The method according to claim 32 wherein the positioning step is carried out using an open-ended tubular protective device.

34. The method according to claim 32 further comprising maintaining the protective device substantially in place axially along the tissue path during the second moving step.

35. The method according to claim 32 wherein the positioning step is carried out using a radially expandable and collapsible protective device.

36. The method according to claim 35 wherein:

the positioning step is carried out with the protective device in a radially-collapsed state; and

further comprising;

expanding at least a distal portion of the protective device from the radially-collapsed state to a radially-expanded state prior to the tissue moving step.

37. The method according to claim 36 further comprising collapsing the protective device from the radially-expanded state to a second radially-collapsed state prior to the tissue moving step, whereby the size of the access site may be smaller than the tissue moved from the target site.

38. The method according to claim 37 wherein the expanding step is carried out using a tubular enlarger extendable into the protective device during said expanding step, the tubular expander being removable from the protective device during the collapsing step.

39. A method for maintaining percutaneous access to an excisional site comprising:

positioning first and second locational elements within a patient at a target site, the first and second locational elements carried by first and second elongate elements, the first and second elongate elements extending from the locational elements at the target site, along a tissue track and out through an access site in the patient'"'"'s skin;

removing the first elongate element and first locational element therewith from the patient; and

accessing the target site using the second elongate element and second locational element therewith.

40. The method according to claim 39 wherein the positioning step is carried out with a radially expandable second locational element.

41. The method according to claim 40 further comprising radially expanding the second locational element from a collapsed condition to an expanded condition before the accessing step.

42. The method according to claim 41 wherein the expanding step is carried out with the second locational element comprising a mesh device.

43. The method according to claim 41 wherein the positioning step is carried out with radially expandable first and second location elements, and further comprising expanding the first location element from a collapsed condition to an expanded condition and then contracting the first location element from the expanded condition to a second collapsed condition.

44. The method according to claim 41 wherein the radial expansion of second element acts to maintain an open space at the target site.

45. A percutaneous access assembly comprising:

first and second separately movable locational devices, each said device comprising a shaft and a radially expandable element mounted to the shaft; and

said radially expandable elements locatable adjacent one another.