Delivery catheter for and method of delivering implant, for example, bronchoscopically implanting a marker in a lung

• US 10,293,135 B2
• Filed: 12/20/2016
• Issued: 05/21/2019
• Est. Priority Date: 10/01/2010
• Status: Active Grant

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Inventors: Quigley, Fergus
• Primary Examiner(s): Neal, Timothy J
• Application Number:
  US15/385,121
• Publication Number:
  US 20170209666A1
• Time in Patent Office: 882 Days
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam

Abstract

Systems and methods for treating a lung of a lung of a patient. One embodiment of a method comprises positioning a leadless marker in the lung of the patient relative to the target, and collecting position data of the marker. This method further comprises determining the location of the marker in an external reference frame outside the patient based on the collected position data, and providing an objective output in the external reference frame that is responsive to movement of the marker. The objective output is provided at a frequency (i.e., periodicity) that results in a clinically acceptable tracking error. In addition, the objective output can also be provided at least substantially contemporaneously with collecting the position data used to determine the location of the marker.

Claims

1. A method of deploying and tracking a marker in a body, the method comprising:

deploying a marker into a lumen within a body, wherein the deploying includes;

positioning a catheter in the lumen within the body,

moving a push wire having an integral retention device contained in the catheter toward a distal end of the catheter to engage the integral retention device with fasteners at a first end portion of the marker, wherein the first end portion of the marker is opposite a second end portion of the marker, the second end portion is positioned proximate to a distal terminus of the catheter, and the first end portion is spaced apart from the distal terminus in a proximal direction,

spring-loading the marker in the catheter while the integral retention device retains the fasteners at the first end of the marker, and

deploying the marker by moving the push wire toward the distal end of the catheter or by fixing the push wire in place and retracting the catheter toward a proximal end of the push wire;

determining a fixed relationship between the marker and a treatment target within the body; and

tracking at least one of position and motion of the marker during treatment.

2. The method of claim 1, wherein positioning includes passing the catheter, push wire, and marker down a working channel of a bronchoscope a selected distance for deployment of the marker into a bronchial lumen of the lung, wherein the working channel of the bronchoscope is lined with polyethylene liner.

3. The method of claim 2 wherein the liner aligns the push wire in a substantial centerline configuration.

4. The method of claim 1 wherein the positioning includes passing the catheter, push wire, and marker down a working channel of a bronchoscope a selected distance for deployment of the marker in a digestive tract lumen.

5. The assembly of claim 1, wherein positioning includes passing the catheter, push wire, and marker down a working channel of a bronchoscope a selected distance for deployment of the marker in a cardiovascular system lumen.

6. The method of claim 1, wherein the marker is a leadless marker having a transponder that has a response signal to an external energy source.

7. The method of claim 1, wherein the marker is radiographically opaque.

8. The method of claim 1, wherein the marker is a radioactive.

9. The method of claim 1, wherein moving the push wire contained in the catheter includes depressing an actuator, and wherein the actuator has indicator marks thereon to indicate when each marker has been deployed.

10. The method of claim 1, further comprising:

interrupting the treatment when the at least one of the position and the motion of the marker exceeds a predetermined offset value; and

repositioning the body to bring the at least one of the position and the motion of the marker below the offset value before continuing the treatment.

11. A method of deploying and tracking markers in a patient according to a radiation plan, the method comprising:

positioning a catheter in a lumen within the patient;

deploying a first marker at a first location proximate a treatment target within the patient, wherein deploying the first marker includes

moving a push wire of the catheter toward a distal end of the catheter or fixing the push wire in place and retracting the catheter toward a proximal end of the push wire, and

releasing an anti-migration device of the first marker from the catheter such that the anti-migration device anchors the first marker at the first location, the anti-migration device having a shell assembly, an anchor sleeve, a fastener, and an anchor disk;

deploying a second marker at a second location proximate the treatment target within the patient;

tracking at least one of position, rotation, and motion of the treatment target, wherein the tracking includes;

collecting at least one of position, rotation, and motion data of the first and second markers during radiation treatment, and

calculating, in real time, at least one of position, rotation, and motion of the first and second markers using the at least one of the position, rotation, and motion data of the first and second markers;

interrupting the radiation treatment when the at least one of the position, rotation, and motion of the first and second markers exceeds a predetermined offset value;

realigning the patient to bring the at least one of the position, rotation, and motion of the first and second markers below the predetermined offset value before continuing the radiation treatment;

determining whether to adapt the radiation plan based on at least one of changes in the treatment target and results of the radiation plan.

12. The method of claim 11, further comprising:

imaging the first marker, the second marker, and the treatment target; and

determining the relative distances between the markers and the relative distances between the markers and the treatment target.

13. The method of claim 11 wherein the first and the second markers are magnetic transponder markers having a circuit configured to be energized by a wirelessly transmitted pulsed magnetic field and to wirelessly transmit a pulsed magnetic location signal in response to the pulsed magnetic field.

14. The method of claim 11, further comprising spring-loading the first marker in the catheter.

15. The method of claim 11 wherein deploying the second marker at the second location proximate the treatment target includes repositioning the catheter to the second location.

16. The method of claim 11 wherein the catheter is a first catheter, and wherein deploying the second marker at the second location proximate the treatment target includes positioning a second catheter to the second location.

17. The method of claim 11 wherein the catheter includes at least one of a perforation, a crease, and a thinned section, and wherein deploying the first marker further includes applying a deployment force that exceeds a breakaway force of the at least one of the perforation, crease, and thinned section of the catheter such that the first marker breaks away and detaches from the catheter.

18. The method of claim 11 wherein the push wire has an integral retention device contained in the catheter, and wherein the method further comprises moving the push wire toward the distal end of the catheter to engage the marker.

19. The method of claim 18 wherein:

the method further comprises spring-loading the fasteners of the first marker in the catheter; and

deploying the first marker includes releasing the first marker from the integral retention device of the push wire such that the fasteners of the first marker extends radially outward fixing the first marker at the first location.

20. The method of claim 19, further comprising engaging a first end portion of the first marker with the integral retention device of the push wire, wherein the first end portion of the first marker is spaced apart from the distal end of the catheter in a proximal direction.