System and method for bracketing and removing tissue

• US 6,363,940 B1
• Filed: 05/14/1998
• Issued: 04/02/2002
• 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): Thaler, Michael H.
• Application Number:
  US09/078,982
• Time in Patent Office: 1,419 Days
• Field of Search: 600/431, 600/420, 600/458, 600/424, 606/1, 606/167, 606/170, 606/184, 128/899, 128/903
• US Class Current: 128/899
• 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 system for defining a boundary of a tissue volume, comprising:

a. a plurality of markers having a maximum dimension of no more than 5 mm, as measured along any axis extending through each of the plurality of markers, wherein each of the plurality of markers includes;

A. an antenna;

B. a circuit connected to the antenna for generating a radio frequency signal, in response to receipt of an exciter signal, having a frequency that is different from frequencies of the radio frequency signals generated by other markers of the plurality of markers; and

C. an exciter for generating the exciter signal, wherein the exciter signal does not include a radio frequency signal having a frequency that is the same as frequencies of the radio frequency signals generated by the plurality of markers;

b. a probe; and

c. a detector connected to the probe that provides information when the probe is moved proximate to the plurality of markers.

2. A system for defining a boundary of a tissue volume, comprising:

a. at least one marker having a maximum dimension of no more than 5 mm, as measured along any axis extending through the at least one marker, wherein the at least one marker vibrates;

b. a probe; and

c. a detector connected to the probe that provides information when the probe is moved proximate to the at least one marker.

3. A system for defining a boundary of a tissue volume, comprising:

a. at least one marker having a maximum dimension of no more than 5 mm, as measured along any axis extending through the at least one marker, wherein the at least one marker includes;

A. a piezo-electric device that oscillates mechanically in response to an oscillating electrical signal; and

B. a circuit connected to the piezo-electric device that generates the oscillating electrical signal;

b. a probe; and

c. a detector connected to the probe that provides information when the probe is moved proximate to the at least one marker.

4. A system according to claim 3, wherein the at least one marker has a housing that is designed to resonate at a first frequency and the piezo-electric device is coupled to the housing so that mechanical oscillations of the piezo-electric device are transmitted from the piezo-electric device to the housing.

5. A system according to claim 3, wherein the at least one marker includes:

a. an antenna for receiving an exciter signal;

b. wherein the circuit is connected to the antenna and is designed to generate the oscillating electrical signal when the antenna receives the exciter signal; and

c. an exciter for generating the exciter signal.

6. A system for defining a boundary of a tissue volume, comprising:

a. at least one marker having a maximum dimension of no more than 5 mm, as measured along any axis extending through the at least one marker, wherein the at least one marker includes a plurality of plates that are configured, positioned and made from a material such that the at least one marker strongly reflects ultrasound energy incident thereon;

b. a probe; and

c. a detector connected to the probe that provides information when the probe is moved proximate to the at least one marker.

7. A system for defining a boundary of a tissue volume, comprising:

a. at least one marker having a maximum dimension of no more than 5 mm, as measured along any axis extending through the at least one marker, wherein the at least one marker includes a capsule filled with a colored dye;

b. a probe; and

c. a detector connected to the probe that provides information when the probe is moved proximate to the at least one marker.

8. A system for identifying, stabilizing and removing a tissue volume comprising:

a. a marker system including;

i. at least one marker having a maximum dimension of no more than 5 mm, as measured along any axis extending through the at least one marker;

ii. a probe; and

iii. a detector connected to the probe that provides information when the probe is moved proximate to at least one marker;

b. a cutter including;

i. a first portion having;

(1) a first blade having a first edge with a first curved configuration;

(2) a first connector;

ii. a second portion having;

(1) a second blade having a second edge, wherein the second edge has a second curved configuration that is designed so that when the second blade is positioned in operative engagement with the first blade, the first edge and the second edge form a substantially continuous cutting edge;

(2) a second connector positioned and designed to releasably engage the first connector to releasably secure the second blade in the operative engagement with the first blade; and

c. a tissue anchor including;

i. an elongate tube having a central bore, a distal end and a proximal end, wherein the tube has at least one aperture adjacent the distal end;

ii. an elongate member having a portion sized for receipt and axial movement in the central bore between a first position and a second position, wherein the elongate member includes a longitudinal axis and at least one anchor member attached to the portion; and

iii. wherein the at least one anchor member is configured and positioned so that when the portion is in the first position the at least one anchor member is at least partially received in the elongate tube and when the portion is in the second position the at least one anchor member projects through the at least one aperture and extends transversely relative to the longitudinal axis.

9. A method of removing a tissue mass and surrounding tissue volume from a piece of tissue, the method comprising the steps:

a. positioning at least one marker in the piece of tissue so as to define a boundary of the tissue volume;

b. identifying the boundary by detecting the position of the at least one marker;

c. incising portions of the tissue volume adjacent the at least one marker substantially along the boundary based on the position of the at least one marker; and

d. stabilizing the tissue volume during the incising step;

wherein the identifying step and incising step are repeated until the tissue volume is removed from the piece of tissue.

10. A method of removing a tissue mass and surrounding tissue volume from a piece of tissue, the method comprising the steps;

a. positioning at least one marker in the piece of tissue so as to define a boundary of the tissue volume;

b. identifying the boundary by detecting the position of the at least one marker;

c. incising portions of the tissue volume adjacent the at least one marker substantially along the boundary based on the position of the at least one marker; and

d. stabilizing the tissue volume during the incising step by pulling the tissue volume in a first direction;

wherein the incising step is performed so that the incising extends in a second direction that is different than the first direction.

11. A method for removing a tissue mass and surrounding tissue volume from a piece of tissue, the method comprising the steps:

a. positioning at least one marker in the piece of tissue so as to define a boundary of the tissue volume;

b. identifying the boundary by detecting the position of the at least one marker;

c. incising portions of the tissue volume adjacent the at least one marker substantially along the boundary based on the position of the at least one marker; and

d. stabilizing the tissue volume during the incising step;

wherein the stabilizing step involves pulling the tissue volume in a first direction.

12. A method, of removing a tissue volume from a tissue portion using at least one marker, the method comprising the steps:

a. positioning at least one marker so as to define a boundary of the tissue volume wherein said at least one marker comprises a plurality of markers, and wherein positioning the at least one marker comprises positioning a plurality of the markers in the tissue volume;

b. detecting the locations of the plurality of markers; and

c. incising portions of the tissue portion adjacent the at least one marker substantially along the boundary adjacent the location.

13. A method according to claim 12, wherein the positioning step is performed so that the plurality of markers define the boundary in three dimensions.

14. A method according to claim 12, wherein the positioning step is performed so that the plurality of markers define the boundary in two dimensions.

15. A method according to claim 12, wherein the positioning step is performed so that the plurality of markers define the boundary in one dimension.

16. A method according to claim 12, wherein the plurality of markers includes three pairs of markers, further wherein the positioning step involves positioning the three pairs of markers so that markers of each pair lie on the boundary in mutually spaced relation substantially on opposite sides of the tissue volume.

17. A method according to claim 12, wherein the positioning step involves positioning the plurality of markers so that at least two of the plurality of markers lie on an X axis and at least two of the plurality of markers lie on a Y axis, wherein the X axis and the Y axis intersect the tissue volume and extend in non-coaxial relation.

18. A method according to claim 12, further including the steps of repeating the detecting step and the incising step with respect to other ones of the plurality of markers.

19. A method according to claim 12, further including the steps of repeating the detecting step and the incising step with respect to all of the plurality of markers until the tissue volume is separated from the tissue portion.

20. A method of bracketing a tissue mass in a piece of tissue using a least one marker, the method comprising the steps:

a. generating an image of the tissue mass;

b. referring to the image of the tissue mass and positioning a plurality of markers in the piece of tissue so as to define the boundary of the tissue volume; and

c. locating the markers using a device that provides information when the device is moved proximate to at least one of the markers.

21. A method according to claim 20, wherein the step b involves positioning the plurality of markers so that two of the plurality of markers are positioned on an X axis, two of the plurality of markers are positioned on a Y axis and two of the plurality of markers are positioned on a Z axes, the X, Y and Z axes intersecting the tissue volume and extending in non-coplanar relation.

22. A method according to claim 20, wherein the step b involves positioning the plurality of markers so that the X, Y and Z axes are substantially mutually orthogonal.

23. A method according to claim 20, wherein the step b is performed so that the plurality of markers defines the boundary in one dimension.

24. A method according to claim 20, wherein the step b is performed so that the plurality of markers define the boundary in two dimensions.

25. A method according to claim 20, wherein the step b is performed so that the plurality of markers defines the boundary in three dimensions.

26. A method according to claim 20, wherein the step b is performed so that the at least two of the plurality of markers are positioned on an X₁ axis and at least two of the plurality of markers ate positioned on a Y₁ axis, wherein the X₁ axis and the Y₁ axis are offset along the Z axis, respectively, from the X axis and the Y axis.