System and method for bracketing and removing tissue

• US 6,918,919 B2
• Filed: 03/22/2001
• Issued: 07/19/2005
• Est. Priority Date: 05/14/1998
• Status: Expired due to Term

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Calypso Medical Technologies, Inc. (Siemens AG)
• Inventors: Krag, David N.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US09/815,393
• Publication Number:
  US 20010018594A1
• Time in Patent Office: 1,580 Days
• Field of Search: 606/1, 606/159, 606/170, 606/171, 606/180, 606/184, 606/185, 606/152, 606/153, 606/139, 606/130, 606/206, 606/107, 606/51, 606/83, 606/148, 606/205, 606/157, 606/706, 606/207, 606/108, 606/191, 606/192, 606/194, 600/564, 600/565
• US Class Current: 606/185
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A system and method for bracketing a tissue volume (22) and later locating the bracketed tissue volume. The system includes a plurality of markers (30) and a probe (32) and detector (34) for use in locating the markers by providing information usable by a surgeon that is representative of changes in proximity between the probe and the plurality of markers. The markers have various detection characteristics, e.g., they transmit gamma rays, that are detectable by an associated probe and detector. The tissue volume is removed by manipulating a cutting tool based on the proximity information provided by the detector which can be used by the surgeon to define the boundary of the tissue volume. A two-part cutting tool (200) is provided for removing the tissue volume, and a tissue anchor (300) is provided for stabilizing the tissue during removal. The system and method of the invention are particularly useful in bracketing and then removing a tissue volume from amorphous, pliable tissue such as breast tissue.

Claims

1. A tissue anchor comprising:

a. an elongate tube having a central bore, a closed distal end and a proximal end, wherein said tube has at least first and second apertures angularly spaced about a circumference of the tube;

b. an elongate member having a portion sized for receipt and axial movement in said central bore between a first position and a second position, wherein said elongate member includes a longitudinal axis;

c. a first anchor member attached to said portion of the elongate member and having a first free distal end carrying a first tissue-penetrating barb;

d. a second anchor member attached to said portion of the elongate member and having a second free distal end carrying a second tissue-penetrating barb; and

e. wherein said first and second anchor members are configured and positioned so that when said portion of the elongate member is in said first position each of said first and second anchor members is at least partially received in said elongate tube and when said portion of said elongate member is in said second position said first anchor member projects through said first aperture and extends transversely relative to said longitudinal axis with the first free distal end positioned outwardly of the elongate tube at a first angular orientation relative to said elongate tube, and said second anchor member projects through said second aperture and extends transversely relative to said longitudinal axis with the second free distal end positioned outwardly of the elongate tube at a second angular orientation relative to said elongate tube, said first and second angular orientations being circumferentially spaced from one another about said elongate tube.

2. A tissue anchor according to claim 1, wherein said elongate tube has an outside diameter ranging from 0.5 mm to 12 mm.

3. A tissue anchor according to claim 2, wherein said outside diameter ranges from 1 mm to 3 mm.

4. A tissue anchor according to claim 1, further comprising third and fourth anchor members attached to said portion.

5. A tissue anchor according to claim 4, further comprising third and fourth apertures, with one aperture being associated with each of the first, second, third, and fourth anchor members.

6. A tissue anchor according to claim 5, wherein at least the first anchor member projects from its associated aperture when the elongate member is in its first position.

7. A tissue anchor according to claim 1, wherein each of said first and second anchor members has a curved configuration when said portion is in said second position.

8. A tissue anchor according to claim 1, wherein the closed distal end of the elongate tube is adapted to be advanced into a volume of tissue to position the at least one anchor member for stabilizing deployment into the tissue.

9. A tissue anchor according to claim 1, wherein said at least one anchor member extends distally beyond a distal end of the elongate member when the elongate member is in its first position.

10. A tissue anchor according to claim 9, wherein said first anchor member is curved when in an unbiased state.

11. A tissue anchor according to claim 10, wherein said first anchor member is in its unbiased state when the elongate member is in its second position.

12. A tissue anchor according to claim 10, wherein said first anchor member curves proximally when the elongate member is in its second position.

13. A tissue anchor according to claim 1, wherein said portion of the elongate member is sized for a close sliding fit within the central bore of the elongate tube.

14. A tissue anchor for stabilizing a tissue mass for surgical excision, comprising:

a. an elongate tube having a central bore, a wall, a tapered distal portion that defines a closed distal end adapted to be advanced into the tissue mass, and a plurality of apertures extending through the tapered distal portion;

b. a manually controllable actuator carried by the elongate tube and comprising an elongate member sized for a close sliding fit within the central bore of the elongate tube, the actuator being moveable with respect to the elongate tube between a first position and a second position; and

c. a plurality of manually deployable anchor members, with one anchor member being associated with each aperture of the elongate tube, each of the anchor members being operatively connected to the actuator such that each anchor member assumes a retracted position when the actuator is in its first position and each anchor assumes an extended position when the actuator is in its second position, each anchor member in its retracted position having a major portion received within the central bore of the elongate tube, each anchor member in its extended position projecting outwardly from its associated aperture into the tissue mass and assuming a curved configuration to facilitate stabilization of the tissue mass.

15. A tissue anchor according to claim 14, wherein the apertures of the elongate tube are spaced proximally of the distal end.

16. A tissue anchor according to claim 14, wherein the actuator further comprises a ring carried adjacent a proximal end of the elongate member.

17. A tissue anchor according to claim 14, wherein the actuator further comprises a stop, the stop cooperating with the elongate tube to limit movement of the elongate member with respect to the elongate tube, thereby defining the second position of the actuator.

18. A tissue anchor according to claim 14, wherein each anchor member projects from its associated aperture when the actuator is in its first position.

19. A tissue anchor for stabilizing a tissue mass for surgical excision, comprising:

a. an elongate tube having a distal end adapted to be advanced into the tissue mass, a central bore, a wall, a tapered distal portion that defines a closed distal end and a plurality of apertures extending through the tapered distal portion;

b. a manually controllable actuator carried by the elongate tube and comprising an elongate member slidably received within the central bore of the elongate tube, the actuator being moveable with respect to the elongate tube between a first position and a second position; and

c. a plurality of manually deployable anchor members, with one anchor member being associated with each aperture of the elongate tube, each of the anchor members being attached to the elongate member for movement therewith such that each anchor member assumes a retracted position when the actuator is in its first position and each anchor assumes an extended position when the actuator is in its second position, each anchor member in its retracted position having a major portion received within the central bore of the elongate tube, each anchor member in its extended position projecting outwardly from its associated aperture into the tissue mass and assuming a curved configuration to facilitate stabilization of the tissue mass.

20. A tissue anchor according to claim 19, wherein the elongate member is moved distally as the actuator moves from its first position to its second position.

21. A tissue anchor for stabilizing a tissue mass for surgical excision, comprising:

a. an elongate tube having a closed distal end, a central bore, a wall, a tapered distal portion that defines a closed distal end, and four apertures extending through the wall at locations spaced angularly about a circumference of the tapered distal portion;

b. a rod having a manually engageable member adjacent its proximal end and a length which is slidably received in the central bore of the elongate tube, the rod being moveable distally with respect to the elongate tube from a first position to a second position; and

c. four anchor members, with one anchor member being associated with each aperture of the elongate tube, each of the anchor members being connected to the rod for movement therewith such that each anchor member assumes a retracted position when the rod is in its first position and each anchor member assumes an extended position when the rod is in its second position, each anchor member in its retracted position having a majority of its length received within the central bore of the elongate tube, each anchor member in its extended position projecting outwardly from its associated aperture into the tissue mass and assuming a curved configuration to facilitate stabilization of the tissue mass.

22. A tissue anchor according to claim 21, wherein the apertures of the elongate tube are spaced proximally of the distal end.

23. A tissue anchor according to claim 21, wherein the rod further comprises a stop, the stop cooperating with the elongate tube to limit movement of the rod with respect to the elongate tube, thereby defining the second position of the rod.

24. A tissue anchor according to claim 21, wherein the anchor members are attached to the rod and extend distally beyond a distal end of the rod.

25. A tissue anchor according to claim 21, wherein a small portion of each anchor member projects from its associated aperture when the rod is in its first position.

26. A method of stabilizing a tissue mass using the tissue anchor of claim 21, comprising:

a. with the rod in its first position, advancing the distal end of the elongate tube into the tissue mass;

b. thereafter, advancing the rod distally to its second position, thereby forcing the anchor members outwardly from the elongate tube and into the tissue mass to stabilize the tissue mass; and

c. thereafter, drawing the tissue anchor proximally to apply tension to the tissue mass.

27. A method according to claim 26, further comprising leaning the elongate tube and the elongate rod after the anchor members are deployed in the tissue mass to facilitate surgical removal of the tissue mass.

28. A method of removing a tissue mass from a tissue using the tissue anchor of claim 21, comprising:

a. with the anchor members in their retracted positions, advancing the distal end of the elongate tube into the tissue mass;

b. thereafter, advancing the rod distally to its second position, thereby forcing the anchor members outwardly from the elongate tube and into the tissue mass;

c. thereafter, stabilizing the tissue mass with the tissue anchor while cutting the tissue; and

d. removing the tissue mass.

29. A method of stabilizing a tissue mass using the tissue anchor of claim 21, comprising:

a. with the rod in its first position, advancing the distal end of the elongate tube into the tissue mass;

b. thereafter, advancing the rod distally to its second position, thereby forcing the anchor members outwardly from the elongate tube and into the tissue mass to stabilize the tissue mass; and

c. thereafter, leaning the elongate tube and the elongate rod to facilitate surgical removal of the tissue mass.

30. A tissue anchor for stabilizing a tissue mass for surgical excision, comprising:

a. manually graspable elongate tube having a distal end, a central bore, a wall, a tapered distal portion that defines a closed distal end, and four apertures extending through the tapered distal portion, the tapered distal portion being configured to enable a length of the elongate tube to be inserted into the tissue mass;

b. a rod having a length which is slidably received in the central bore of the elongate tube, the rod being moveable distally with respect to the elongate tube from a first position; and

c. four anchor members, with one anchor member being associated with each aperture of the elongate tube, each of the anchor members being connected to the rod for movement therewith such that a majority of the length of each anchor member is received within the central bore of the elongate tube when the rod is in its first position and each anchor member moves outwardly from its associated aperture into the tissue mass to assume a curved configuration within the tissue mass to facilitate stabilization of the tissue mass when the rod is moved distally.

31. A method of removing a tissue mass from a tissue, comprising:

a. providing a tissue anchor comprising an elongate tube having a distal end and a plurality of apertures;

a manually controllable actuator; and

a plurality of anchor members operatively connected to the actuator;

b. advancing the distal end of the elongate tube into the tissue mass to a desired location;

c. thereafter, manually moving the actuator to deploy the anchor members outwardly from the elongate tube though the apertures, thereby forcing the anchor members into the tissue mass;

d. thereafter, stabilizing the tissue mass with the tissue anchor while cutting the tissue; and

e. removing the tissue mass.

32. A method according to claim 31, wherein stabilizing the tissue mass includes drawing the tissue anchor proximally, thereby tensioning the tissue mass.

33. A method according to claim 31, further comprising leaning the elongate tube and the elongate rod after the anchor members are deployed in the tissue mass to facilitate surgical removal of the tissue mass.

34. A method of stabilizing a tissue mass during a medical procedure using a tissue anchor which includes an elongate tube having a distal end and a plurality of apertures;

a manually controllable actuator; and

a plurality of anchor members operatively connected to the actuator, the method comprising;

a. grasping the elongate tube of the tissue anchor and advancing the distal end of the elongate tube into the tissue mass to a desired location;

b. thereafter, manually moving the actuator to deploy the anchor members outwardly from the elongate tube though the apertures, with one anchor member advancing through each aperture such that the anchor members curve outwardly from the apertures, thereby extending the anchor members into the tissue mass;

c. thereafter, manually grasping the tissue anchor and drawing the tissue anchor proximally to tension the tissue mass.

35. A tissue anchor for stabilizing a tissue mass for surgical excision, comprising:

a. an elongate tube having a distal end adapted to be advanced into the tissue mass, a central bore, a wall, a tapered distal portion that defines a closed distal end, and a plurality of apertures extending through the tapered distal portion;

b. a manually controllable actuator carried by the elongate tube and being moveable with respect to the elongate tube between a first position and a second position, the actuator including a stop that cooperates with the elongate tube to limit movement of the elongate member with respect to the elongate tube, thereby defining the second position of the actuator; and

c. a plurality of manually deployable anchor members, with one anchor member being associated with each aperture of the elongate tube, each of the anchor members being operatively connected to the actuator such that each anchor member assumes a retracted position when the actuator is in its first position and each anchor assumes an extended position when the actuator is in its second position, each anchor member in its retracted position having a major portion received within the central bore of the elongate tube, each anchor member in its extended position projecting outwardly from its associated aperture into the tissue mass and assuming a curved configuration to facilitate stabilization of the tissue mass.