Systems and methods for targeting a lesion

• US 6,731,966 B1
• Filed: 05/03/2000
• Issued: 05/04/2004
• Est. Priority Date: 03/04/1997
• Status: Expired due to Fees

• Current Assignee: Foley Hoag LLP
• Original Assignee: Foley Hoag LLP
• Inventors: Theriault, Richard H., Spigelman, Zachary S.
• Primary Examiner(s): RUHL, DENNIS WILLIAM
• Assistant Examiner(s): Pass, Barry
• Application Number:
  US09/565,183
• Time in Patent Office: 1,462 Days
• Field of Search: 600/407, 600/410, 600/461, 600/567, 600/417, 378/37, 378/417
• US Class Current: 600/407
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00429 with a roughened portion
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/008 Removal of tumors
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• 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 6/0414 with compression means
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 8/0825 for diagnosis of the breast, e.g. mammography
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

The present invention provides systems and methods for guiding a surgical instrument into a preselected spatial relationship with a lesion, in particular a lesion of the breast. In an exemplary embodiment, the system includes a data translation system that translates a set of data points representing the position of the lesion into a set of three dimensional coordinates, and also includes a tracking system that tracks the position of a surgical instrument in three dimensional space, and further includes a representation system that produces a representation of the position of the surgical instrument relative to the lesion. The systems of the present invention are correlated with methods for biopsying a lesion and for surgically removing a lesion.

Claims

1. A system for guiding a surgical instrument into a spatial relationship with a lesion, comprising:

a data translation system for translating a set of data points representative of a position of the lesion in at least two two-dimensional planes into a set of three-dimensional coordinates representative of the position of the lesion in three-dimensional space,

a tracking system including a sensor positioned on the surgical instrument to generate tracking signals derived from the sensor for identifying the position of the surgical instrument in three dimensional space, and

a representation system for producing a representation of the position of the surgical instrument and the position of the lesion in three dimensional space relative to each other, as a function of the tracking signals derived from the sensor and the set of three-dimensional coordinates produced by the data translation system, whereby the placement of the surgical instrument into the anatomic relationship with the lesion is guided by reference to the representation produced by the representation system.

2. The system of claim 1, wherein the set of data points is digitally derived from at least one diagnostic test selected from the group consisting of mammography, ultrasound, MRI, CT scan, PET scan, thermal scan, conventional XRay modalities and radionuclide scan.

3. The system of claim 1, wherein the set of data points identifying the position of the lesion is derived from a set of at least two mammograms.

4. The system of claim 1, wherein said representation system produces a data set representing the position of the surgical instrument and the lesion relative to each other in three-dimensional space.

5. The system of claim 1, wherein the representation produced by the representation system comprises at least one visual image.

6. The system of claim 5, wherein the at least one visual image comprises a non representational image graphically representing the position of the surgical instrument and the lesion relative to each other in three-dimensional space.

7. The system of claim 1, wherein the representation produced by the representation system represents a real-time change in the position of the surgical instrument relative to the lesion.

8. The system of claim 1, further comprising an acquisition system for obtaining the set of data points identifying a position of the lesion in the at least two two-dimensional planes.

9. The system of claim 8, wherein the acquisition system comprises a mammography system.

10. The system of claim 1, further comprising an introduction system wherein the introduction system directs the surgical instrument into the positional relationship with the lesion.

11. A system for guiding a surgical instrument into a spatial relationship with a lesion, comprising:

a data translation system for translating a set of data points representative of the lesion in at least two two-dimensional planes into a set of three-dimensional coordinates representative of the position of the lesion in three-dimensional space,

a positioning system for identifying the position of the lesion in three-dimensional space relative to a three dimensional position of at least one anatomic landmark,

a tracking system disposed in relation to the surgical instrument, wherein said tracking system generates tracking signals for identifying the position of the surgical instrument in three dimensional space, and

a representation system for producing at least one representation relating the position of the surgical instrument in three dimensional space to the position of at least one structure selected from the group consisting of the at least one anatomic landmark and the lesion,

whereby the placement of the surgical instrument into the anatomic relationship with the lesion is guided by reference to the representation produced by the representation system.

12. The system of claim 11, wherein the three-dimensional position of the at least one anatomic landmark is identified by ultrasound.

13. The system of claim 11, wherein the set of data points is digitally derived from at least one diagnostic test selected from the group consisting of mammography, ultrasound, MRI, CT scan, PET scan, thermal scan, conventional XRay modalities and radionuclide scan.

14. The system of claim 11, wherein the positioning system comprises a device for identifying the three-dimensional position of the at least one anatomic landmark in real time.

15. The system of claim 14 wherein the device for identifying the three-dimensional position of the at least one anatomic landmark in real time comprises an ultrasound device.

16. A system for obtaining a tissue sample from a selected area of a breast, comprising:

a surgical instrument adapted for obtaining the tissue sample,

a mammography system for translating two-dimensional data obtained from at least two mammograms into data for identifying a three-dimensional position of the selected area of the breast,

a tracking system for tracking the three-dimensional position of the surgical instrument relative to the selected area of the breast,

a positional representation system for producing a representation that represents the three-dimensional position of the surgical instrument relative to the selected area of the breast in real time, and

an introduction system for directing the surgical instrument in a selected direction relative to the selected area of the breast, said selected direction being determined by reference to the representation produced by the positional representation system,

whereby the surgical instrument is directed to the selected area of the breast, therefrom to obtain the tissue sample.

17. The system of claim 16, wherein the mammography system comprises a reference point external to the breast.

18. The system of claim 16, wherein the introduction system is adapted for use by a human operator.

19. A mammography system for orienting a breast to facilitate a biopsy of a breast lesion, comprising

a mammography device for obtaining mammograms in at least two different planes and capable of obtaining mammograms in a plurality of planes relative to a defined axis of a breast,

a first set of mammograms, wherein said first set of mammograms identifies a position of the breast lesion within the breast,

a first set of two-dimensional coordinates that corresponds to the first set of mammograms,

an adjustment system adapted to generate a set of positional instructions for the mammography device from the first set of mammograms, wherein the set of positional instructions directs the positioning of the mammography device relative to the breast to obtain a second set of mammograms wherein the breast lesion is located centrally on at least one mammogram, and

a compression system for securing the breast in relation to the mammography system so that the position of the lesion within the breast relative to the mammography system corresponds to the position of the lesion located on the second set of mammograms,

thereby orienting the breast to facilitate the biopsy of the breast lesion.

20. A method for obtaining a tissue sample from a target area of a breast, comprising:

identifying the target area on at least two mammograms,

determining the position of the target area on the at least two mammograms,

digitizing data correlated with the at least two mammograms that represents the position of the target area,

determining the position of the target area in three-dimensional space using digitized data correlated with the at least two mammograms,

creating a first representation from the digitized data indicating the position of the target area in three-dimensional space,

providing a surgical instrument for obtaining the tissue sample,

tracking the position of the surgical instrument relative to the target area,

creating a second representation, wherein the second representation indicates in real time the position of the surgical instrument relative to the position of the target area,

directing the surgical instrument to the selected area of the breast by referring to the second representation, and

employing the surgical instrument to obtain a tissue sample from the selected area of the breast.

21. A method for directing a biopsy of a breast lesion, comprising:

analyzing a set of data correlated with a first set of at least two mammograms to produce a set of correction factors for positioning a mammography device on a breast, whereby said correction factors orient the mammography device so that the breast lesion is centrally located relative to at least one plane for mammogramming the breast,

positioning the mammography device according to the correction factors,

securing the breast in the mammography device,

producing a second set of at least two mammograms based on the position of mammography device as oriented according to the correction factors, and

using the second set of at least two mammograms to direct the biopsy of the breast lesion.

22. A method for treating a breast abnormality, comprising:

identifying the breast abnormality on at least two mammograms,

determining a position of the breast abnormality on at least two mammograms,

digitizing data correlated with the at least two mammograms that represents the position of the breast abnormality,

creating from the digitized data a first representation of the position of the breast abnormality,

providing a surgical instrument for treating the breast abnormality,

tracking the position of the surgical instrument relative to the breast abnormality,

creating a second representation, wherein the second representation indicates in real time the position of the surgical instrument relative to the position of the breast abnormality,

directing the surgical instrument to the breast abnormality by referring to the second representation,

positioning the surgical instrument in proximity to the breast abnormality, and

employing the surgical instrument to deliver a treatment to the breast abnormality.