Brachytherapy fiducial needle fixation system and method

• US 10,449,387 B2
• Filed: 06/24/2014
• Issued: 10/22/2019
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Cowles Ventures LLC
• Original Assignee: Breast Microseed, Inc.
• Inventors: Pitman, Charlie
• Primary Examiner(s): Dorna, Carrie R
• Application Number:
  US14/313,978
• Publication Number:
  US 20140309525A1
• Time in Patent Office: 1,946 Days
• Field of Search: 600 1- 8, 604116
• 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 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 2005/1012 Templates or grids for guiding the introduction of sources
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam

Abstract

A mechanism to facilitate the insertion of radioactive sources/source strands into soft tissue, such as breast tissue, and a method that utilizes this mechanism with the goal of improving the reproducibility of the procedure and ensuring that the sources are reliably and consistently inserted in an exact position per a patient prescription treatment plan from patient to patient as well as improve the ease-of-use of the device and procedure are provided.

Claims

1. A method, comprising:

providing at least one fiducial needle having a proximal end being used to locate and fixate tissue into which the at least one fiducial needle is inserted and a distal end being inserted through a grid that fixates the at least one fiducial needle to the tissue;

inserting the at least one fiducial needle into the tissue using medical imaging;

locking the at least one fiducial needle relative to a fixed frame of reference;

placing the grid onto the at least one fiducial needle so that the at least one fiducial needle passes through the grid, locking the at least one fiducial needle relative to the grid and locking the grid relative to the fixed frame of reference;

passing a needle containing a radioactive source into the tissue fixated by the at least one fiducial needle, the radioactive source needle passing through one of a plurality of radioactive source needle holes in the grid that is locked relative to the at least one fiducial needle.

2. The method of claim 1, wherein locking the grid relative to the fixed frame of reference further comprises threadably attaching, using an attachment ball device, the grid to the fixed frame of reference wherein locking the at least one fiducial needle relative to the grid further comprises attaching a fiducial needle lock to the grid and tightening a locking pin using the fiducial needle lock to lock the position of at least one fiducial needle relative to the grid.

3. The method of claim 2, wherein tightening the locking pin using the fiducial needle lock further comprises pressing a side of each fiducial needle hole in the locking pin against each of the fiducial needles passing through the fiducial needle lock when the locking pin is in a locked position and moving the locking pin, using a set of outer threads of the locking pin that cooperate with the fiducial needle lock, between an unlocked position and the locked position.

4. The method of claim 1, wherein the grid further comprises a parallelogram array of the radioactive source needle holes and wherein the one or more fiducial needle holes are along a center line of the grid.

5. The method of claim 1 further comprising visualizing each fiducial needle using a visualization feature on each fiducial needle.

6. The method of claim 5 further comprising anchoring each fiducial needle into the tissue.

7. The method of claim 6, wherein anchoring each fiducial needle further comprises using one or more user deployable projection to anchor the fiducial needle into the tissue.

8. A method, comprising:

providing at least one fiducial needle having a proximal end being used to locate and fixate tissue into which the at least one fiducial needle is inserted and a distal end being inserted through a grid that fixates the at least one fiducial needle to the tissue;

inserting the at least one fiducial needle into the tissue using medical imaging;

locking the at least one fiducial needle relative to a fixed frame of reference and locking the at least one fiducial needle to the grid, wherein locking the at least one fiducial needle relative to the grid further comprises allowing a radioactive source needle to freely slide relative to the grid; and

passing the radioactive source needle into the tissue fixated by the at least one fiducial needle, the radioactive source needle passing through one of a plurality of radioactive source needle holes in the grid that is locked relative to the at least one fiducial needle.

9. A method, comprising:

providing at least one fiducial needle having a proximal end being used to locate and fixate tissue into which the at least one fiducial needle is inserted and a distal end being inserted through a grid that fixates the at least one fiducial needle to the tissue;

inserting the at least one fiducial needle into the tissue using medical imaging;

locking the at least one fiducial needle relative to a fixed frame of reference and locking the at least one fiducial needle to the grid;

removably securing the grid to the fixed frame of reference using an engagement device having a ball portion and a socket portion, wherein removably securing the grid to the fixed frame of reference further comprises removably inserting the ball portion of the engagement device into the socket portion of the engagement device to secure the grid to the fixed frame of reference; and

passing a needle containing a radioactive source into the tissue fixated by the at least one fiducial needle, the radioactive source needle passing through one of a plurality of radioactive source needle holes in the grid.