SURGICAL GUIDANCE SYSTEMS, DEVICES, AND METHODS

• US 20160220314A1
• Filed: 03/12/2015
• Published: 08/04/2016
• Est. Priority Date: 03/12/2014
• Status: Active Grant

• Current Assignee: ProxiMed, LLC
• Original Assignee: ProxiMed, LLC
• Inventors: Huelman, Justin, Wu, Andrew, Jung, Michael, Child, Marc, Sharma, Vidit, Mccaslin, Addason
• Granted Patent: US 10,342,623 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• 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 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2562/0223 Magnetic field sensors
• CPC Class Codes: A61B 2562/0257 Proximity sensors
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Abstract

Surgical systems and methods for avoiding injury to an anatomical structure are disclosed. According to some aspects, an implantable device configured to emit a detectable field may be attached to the anatomical structure. A proximity sensor may be attached to a distal end of a surgical instrument and may be configured to detect the detectable field. A control unit in communication with the proximity sensor may be configured to use the proximity sensor to determine if the distal end of the surgical instrument is within a predetermined distance of the implantable device. If so, a notification such as a vibration or alarm may be provided to a user of the surgical instrument so that the user can maneuver the surgical instrument to limit or prevent contact with the anatomical structure.

Claims

1. A surgical guidance system comprising:

an implantable device configured for attachment to an anatomical structure and to emit a detectable field;

a surgical instrument having a proximal end and a distal end, the surgical instrument being movable relative to the implantable device;

a proximity sensor attached to the distal end of the surgical instrument and configured to detect the detectable field; and

a control unit in communication with the proximity sensor and configured to use the proximity sensor to determine if the distal end of the surgical instrument is within a predetermined distance of the implantable device.

2. The surgical guidance system of claim 1, the detectable field having an intensity that varies with distance from the implantable device, and the control unit being configured to use the proximity sensor to determine the intensity of the detectable field.

3. The surgical guidance system of claim 2, the control unit being configured to determine that the distal end of the surgical instrument is within the predetermined distance of the implantable device in response to a determination that the intensity of the detectable field is equal to or greater than a threshold intensity.

4. The surgical guidance system of claim 1, comprising a notification unit in communication with the control unit and configured to notify a user of the surgical instrument that the distal end of the surgical instrument is within the predetermined distance of the implantable device.

5. The surgical guidance system of claim 4, the notification unit being configured to vibrate in response to a determination that the distal end of the surgical instrument is within the predetermined distance of the implantable device.

6. The surgical guidance system of claim 1, the implantable device including a plurality of magnets, and the detectable field including a magnetic field emitted by the plurality of magnets.

7. The surgical guidance system of claim 6, the implantable device including a flexible tubular member having a longitudinal axis, and the plurality of magnets being arranged adjacent one another and parallel to the longitudinal axis.

8. The surgical guidance system of claim 7, each one of the plurality of magnets being spaced apart from an adjacent one of the plurality of magnets.

9. An implantable device for marking a location of an anatomical structure, the implantable device comprising:

a body configured for attachment to the anatomical structure; and

a beacon configured to emit a detectable field having an intensity that varies with distance.

10. The implantable device of claim 9, the body comprising a flexible tubular member that extends along a longitudinal axis.

11. The implantable device of claim 10, the beacon comprising a plurality of magnets attached to the tubular member and arranged adjacent one another and parallel to the longitudinal axis, the detectable field being defined by a magnetic field emitted by the plurality of magnets.

12. The implantable device of claim 11, each one of the plurality of magnets being spaced apart from an adjacent one of the plurality of magnets by at least 8.0 mm.

13. The implantable device of claim 11, the body comprising first and second coiled members arranged at opposite ends of the flexible tubular member, the first coiled member being dimensioned to be disposed within a kidney, the second coiled member being dimensioned to be disposed within a bladder.

14. The implantable device of claim 13, the flexible tubular member having an outer diameter less than or equal to an inner diameter of a human ureter.

15. A surgical method comprising:

introducing an implantable device into a patient and attaching the implantable device to an anatomical structure, the implantable device being configured to emit a detectable field having an intensity that varies with distance;

introducing a distal end of a surgical instrument into the patient and advancing the distal end of the surgical instrument toward the implantable device;

detecting, with a proximity sensor attached to the distal end of the surgical device, the intensity of the detectable field as the distal end of the surgical instrument is advanced toward the implantable device;

determining, with a control unit in communication with the proximity sensor, if the distal end of the surgical instrument is within a predetermined distance of the implantable device based on the intensity of the detectable field; and

receiving a notification that the distal end of the surgical instrument is within a predetermined distance of the implantable device.

16. The surgical method of claim 15, comprising, in response to the notification, maneuvering the distal end of the surgical instrument to avoid or limit contact with the anatomical structure.

17. The surgical method of claim 15, comprising, in response to the notification, advancing the distal end of the surgical instrument toward the implantable device at least until the distal end of the surgical instrument contacts the anatomical structure.

18. The surgical method of claim 15, comprising ceasing further advancement of the distal end of the surgical instrument toward the implantable device in response to the notification.

19. The surgical method of claim 15, wherein the notification is a vibration generated in a handle unit of the surgical instrument.

20. The surgical method of claim 15, the implantable device including a plurality of magnets, and the detectable field including a magnetic field emitted by the plurality of magnets.

21. The surgical method of claim 19, the implantable device including a flexible tubular member having a longitudinal axis, and the plurality of magnets being arranged adjacent one another and parallel to the longitudinal axis.

22. The surgical method of claim 21, each one of the plurality of magnets being spaced apart from an adjacent one of the plurality of magnets.

23. A surgical device comprising:

a proximal end configured to be positioned exterior to a patient during a surgical procedure;

a distal end configured to be introduced inside the patient during the surgical procedure;

a proximity sensor attached to the distal end of the surgical device and configured to detect a detectable field emitted by a beacon implanted inside the patient; and

a notification unit attached to the proximal end of the surgical instrument and configured to notify a user of the surgical device that the distal end of the surgical instrument is within a predetermined distance of the beacon.

24. The surgical device of claim 23, comprising a control unit configured to receive detection signals from the proximity sensor, determine whether the distal end of the surgical device is within a predetermined distance of the beacon, and output a control signal that activates the notification unit.

25. The surgical device of claim 24, the notification unit being configured to vibrate at least the proximal end of the surgical device in response to the control signal from the control unit.

26. The surgical device of claim 23, the proximity sensor being removably attached to the distal end of the surgical device.

27. The surgical device of claim 23, the proximity sensor including a Hall Effect sensor configured to detect a magnetic field emitted by the beacon.

28. The surgical device of claim 23, the proximity sensor including a magnetometer configured to detect a magnetic field emitted by the beacon.

29. The surgical device of claim 23, comprising a surgical tool attached to the distal end of the surgical device, the surgical tool including at least one of:

graspers, scissors, calipers, forceps, an occluder, a clamp, a retractor, a distractor, a scalpel, a lancet, a drill, a drill bit, rasps, trocars, a harmonic scalpel, rongeurs, a dilator, a specula, a suction tube, a stapler, a needle, a probe, an endoscope, a mechanical cuter, an ultrasonic cutter, or a laser cutter.