Apparatus, systems, and methods for localizing markers or tissue structures within a body

• US 8,892,185 B2
• Filed: 06/25/2010
• Issued: 11/18/2014
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Chi Sing, Eduardo, Cole, Mark A., Nguyen, Tommy G.
• Primary Examiner(s): Roy, Baisakhi
• Application Number:
  US12/824,139
• Publication Number:
  US 20110021888A1
• Time in Patent Office: 1,607 Days
• Field of Search: 600/407, 600/424, 600/437, 606/41
• US Class Current: 600/424
• CPC Class Codes: A61B 2017/00438 connectable to a finger
• CPC Class Codes: A61B 2017/00442 connectable to wrist or forearm
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/397 electromagnetic other than visible, e.g. microwave
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• 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 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Apparatus, systems, and methods are provided for localizing lesions within a patient'"'"'s body, e.g., within a breast. The system may include one or more markers implantable within or around the target tissue region, and a probe for transmitting and receiving electromagnetic signals to detect the one or more markers. During use, the marker(s) are into a target tissue region, and the probe is placed against the patient'"'"'s skin to detect and localize the marker(s). A tissue specimen, including the lesion and the marker(s), is then removed from the target tissue region based at least in part on the localization information from the probe.

Claims

1. A system for localization of a target tissue region within a patient'"'"'s body, comprising:

a probe comprising a substantially flat patient contact surface and one or more antennas for transmitting electromagnetic signals into a patient'"'"'s body and receiving reflected signals from the patient'"'"'s body, through the patient contact surface, the probe analyzing the reflected signals to identify one or more objects within the patient'"'"'s body; and

a marker sized and configured for implantation directly in tissue within a patient'"'"'s body independent of a delivery device used to deliver the marker;

the marker comprising an active reflector to enhance identification of the marker by the probe.

2. The system of claim 1, wherein the marker comprises a plurality of beads carried by an elongate core member, the beads configured for enhancing reflection of signals from the probe to facilitate identification of the marker.

3. The marker of claim 2, wherein a predetermined surface finish is provided on one or more of the beads to modulate signals reflected from the one or more beads to enhance identification of the marker.

4. The system of claim 1, wherein the marker comprising an electronic circuit that modulates incident signals from the probe striking the marker such that reflected signals from the marker to enhance identification by the probe.

5. The system of claim 4, wherein the electronic circuit imposes a phase shift on the reflected signals.

6. The system of claim 1, wherein the marker is configured for enhancing a radar cross section (“

RCS”

) of the marker to enhance identification of the marker by the probe.

7. The system of claim 1, wherein the marker is biased to assume a nonlinear shape yet is resiliently flexible to allow the core member to be straightened to facilitate introduction of the marker into a target tissue region.

8. The system of claim 1, further comprising a delivery device for introducing the marker into a patient'"'"'s body, the delivery device comprising a substantially rigid cannula having a sharpened tip for penetrating through tissue.

9. The system of claim 1, wherein the marker comprises an elongate core member, and an electronic circuit that modulates electromagnetic signals striking the marker such that reflected signals enhance identification of the marker.

10. The system of claim 9, wherein the core member is biased to a non-linear shape yet is resiliently flexible to allow the core member to be straightened to facilitate loading the marker into a delivery device.

11. The system of claim 9, wherein the electronic circuit comprises one or more of a diode and a FET transistor.

12. The system of claim 1, wherein the marker has a length no greater than four millimeters (4.0 mm).

13. The system of claim 1, wherein the marker is configured for implantation independent of any other devices or tethers.

14. The system of claim 1, wherein the marker includes first and second free and untethered ends.

15. A system for localization of a target tissue region within a patient'"'"'s body, comprising:

a probe comprising a patient contact surface for placement against a patient'"'"'s skin and one or more antennas for transmitting micro-impulse radar signals into a patient'"'"'s body and receiving reflected signals from the patient'"'"'s body through the patient contact surface, the probe analyzing the reflected signals to identify one or more objects within the patient'"'"'s body; and

a marker sized for implantation in tissue within a patient'"'"'s body, the marker comprising a core member biased to a curvilinear shape for deployment within tissue and resiliently flexible to be straightened to a linear shape for loading into a delivery device, the marker comprising one or more elements to enhance identification of the marker by the probe.

16. The system of claim 15, wherein the one or more elements comprise an electronic circuit that modulates electromagnetic signals striking the marker such that reflected signals enhance identification of the marker.

17. The system of claim 16, wherein the electronic circuit comprises one or more of a diode and a FET transistor.

18. A system for localization of a target tissue region within a patient'"'"'s body, comprising:

a delivery device comprising a shaft including a proximal end and a sharpened distal end sized for percutaneous introduction through tissue within a patient'"'"'s body into a target tissue region, the delivery device carrying one or more markers implantable in tissue within or around the target tissue region and including a pusher member for deploying the one or more markers from the delivery device; and

a probe comprising one or more antennas for transmitting and receiving micro-impulse radar signals to detect the one or more markers implanted within or around the target tissue region when the probe is placed adjacent the target tissue region.

19. The system of claim 18, wherein the delivery device carries a plurality of the markers and is configured for sequentially delivering the markers independently of one another within or around the target tissue region.

20. The system of claim 18, wherein each of the one or more markers comprises a geometric shape.

21. The system of claim 18, wherein each of the one or more markers comprises an elongate core member including first and second free and untethered ends, and a plurality of beads coupled to the core member, the beads comprising a plurality of surfaces and edges at least partially defining outer surfaces of the marker to enhance reflection of electromagnetic signals to facilitate identification of the marker.

22. A system for localization of a target tissue region within a patient'"'"'s body, comprising:

a marker comprising an elongate core member and a plurality of beads coupled to the core member, the beads comprising a plurality of surfaces and edges at least partially defining outer surfaces of the marker to enhance reflection of electromagnetic signals to facilitate identification of the marker; and

a probe comprising one or more antennas for transmitting electromagnetic signals into a patient'"'"'s body and receiving reflected signals from the patient'"'"'s body, the probe analyzing the reflected signals to identify the marker after being implanted within the patient'"'"'s body.

23. The system of claim 22, wherein the core member is biased to a non-linear shape yet is resiliently flexible to allow the core member to be straightened to facilitate loading the marker into a delivery device.

24. The system of claim 23, wherein the core member is biased to a helical shape.

25. The system of claim 23, wherein the core member is biased to a tapered helical shape.

26. The system of claim 23, wherein the core member has a length no greater than ten millimeters (10.0 mm).

27. A system for localization of a target tissue region within a patient'"'"'s body, comprising:

a probe comprising a patient contact surface for placement against a patient'"'"'s skin and one or more antennas for transmitting electromagnetic signals into a patient'"'"'s body and receiving reflected signals from the patient'"'"'s body through the patient contact surface, the probe analyzing the reflected signals to identify one or more objects within the patient'"'"'s body;

a delivery device comprising a substantially rigid shaft including a proximal end and a sharpened distal end sized for percutaneous introduction through tissue within a patient'"'"'s body into a target tissue region, and a pusher member slidably disposed within a lumen of the delivery device; and

a marker received within the lumen of the delivery device and deployable from the delivery device using the pusher member for implantation in tissue within a patient'"'"'s body comprising an elongate core member having first and second free ends, the core member biased to a non-linear shape yet resiliently flexible to allow the core member to be straightened to facilitate loading the marker into the lumen of the delivery device, and an electronic circuit carried by the core member, the electronic circuit modulating electromagnetic signals striking the marker such that reflected signals enhance identification of the marker.

28. The system of claim 27, further comprising a plurality of beads coupled to the core member, the beads comprising a plurality of flat surfaces and abrupt corners to enhance reflection of electromagnetic signals to facilitate identification of the marker.

29. The system of claim 27, wherein the electronic circuit comprises one or more of a diode and a FET transistor.

30. The system of claim 27, wherein the core member is biased to a non-linear shape when deployed from the lumen of the delivery device yet is resiliently flexible to allow the core member to be straightened to facilitate loading the marker into the lumen of the delivery device.