Brachytherapy fiducial needle fixation system and method

• US 8,764,619 B2
• Filed: 04/21/2009
• Issued: 07/01/2014
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Cowles Ventures LLC
• Original Assignee: Breast Microseed, LLC
• Inventors: Pitman, Charlie
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US12/427,667
• Publication Number:
  US 20100268014A1
• Time in Patent Office: 1,897 Days
• Field of Search: 600 1- 8, 600/414, 600/420, 600424-427, 600431-436, 604/116, 604/117
• US Class Current: 600/7
• 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 brachytherapy radioactive source implantation device, comprising:

one or more fiducial needles, each fiducial needle having a tip portion, a visualization portion and a shaft portion, the visualization portion having one or more visualization features that allow the position of the fiducial needle within tissue to be precisely determined when visualized using an imaging device; and

a needle fixation device having one or more fiducial needle holes and a plurality of radioactive source needle holes, the one or more fiducial needle holes being lockable to lock one or more fiducial needles into a fixed position relative to the needle fixation device and the plurality of radioactive source needle holes not being lockable, wherein the needle fixation device further comprises an attachment ball device that threadably attaches the needle fixation device to a fixed frame of reference, a fiducial needle lock, a template having the one or more fiducial needle holes and the plurality of radioactive source needle holes and a locking pin wherein the locking pin is tightened using the fiducial needle lock to lock the position of the one or more fiducial needles relative to the template, wherein the locking pin further comprises a set of fiducial needle holes wherein a side of the fiducial needle holes are pressed against the one or more fiducial needles in the needle fixation device when the locking pin is in a locked position, a set of radioactive source needle holes, a set of outer threads that cooperate with the fiducial needle lock to move the locking pin between an unlocked position and a locked position and a set of inner threads that cooperate with the attachment ball device to attach the needle fixation device to the fixed frame of reference.

2. The device of claim 1, wherein the template 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 template.

3. The device of claim 1, wherein each visualization feature further comprises a recessed portion and a raised portion that reflect the energy from the imaging device.

4. The device of claim 3, wherein the imaging device further comprises an ultrasound device that generates ultrasound energy.

5. The device of claim 1, wherein each shaft portion has one of a round cross section, a square cross section, a triangular cross section, a hexagonal cross section and an octagonal cross section.

6. The device of claim 1, wherein each fiducial needle further comprises a retention feature that anchors the fiducial needle into the tissue.

7. The device of claim 6, wherein the retention feature further comprises one or more user deployable projection that anchors the fiducial needle into the tissue.

8. The device of claim 1, further comprising an engagement device that removably secures the needle fixation device to the fixed frame of reference.

9. The device of claim 8, wherein the engagement device further comprises a socket portion and wherein the attachment ball device further comprises a ball portion wherein the ball portion is removably inserted into the socket portion to secure the needle fixation device to the fixed frame of reference.

10. The device of claim 9 further comprising a stereotactic armature removably attached to an operating table wherein the stereotactic armature further comprises the engagement device so that the needle fixation device is fixed in position relative to the operating table.

11. A fiducial needle fixation device, comprising:

a body portion;

one or more fiducial needle holes in the body portion;

a plurality of radioactive source needle holes in the body portion; and

wherein

the one or more fiducial needle holes are lockable to lock one or more fiducial needles into a fixed position relative to the body portion and the plurality of radioactive source needle holes not being lockable;

an attachment ball device that threadably attaches the needle fixation device to a fixed frame of reference, a fiducial needle lock, a template having the one or more fiducial needle holes and the plurality of radioactive source needle holes and a locking pin wherein the locking pin is tightened using the fiducial needle lock to lock the position of the one or more fiducial needles relative to the template; and

wherein the locking pin further comprises a set of fiducial needle holes wherein a side of the fiducial needle holes are pressed against the one or more fiducial needles in the needle fixation device when the locking pin is in a locked position, a set of radioactive source needle holes, a set of outer threads that cooperate with the fiducial needle lock to move the locking pin between an unlocked position and a locked position and a set of inner threads that cooperate with the attachment ball device to attach the needle fixation device to the fixed frame of reference.

12. The device of claim 11, wherein the template 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 template.