Nerve and soft tissue ablation device and method

• US 9,198,707 B2
• Filed: 03/15/2013
• Issued: 12/01/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F., Roy, Josee
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/835,424
• Publication Number:
  US 20140276702A1
• Time in Patent Office: 991 Days
• Field of Search: 606 20- 23
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

An ablation device and method for monitoring and controlling temperature, pressure and position of an ablation probe for precise destruction of unwanted one of nerve tissue and soft tissue. The ablation device includes a probe configured to generate pressure and temperature for ablating the unwanted soft tissue and nerve tissue The device can also include a monitoring device, an imaging device, and a computer system. The probe includes at least two prongs, the at least two prongs each including distal ends, the distal ends being configured to define, in combination, a probe geometry substantially matching an anatomical tissue geometry of the unwanted one of nerve tissue and soft tissue.

Claims

1. An ablation device for ablating unwanted one of nerve tissue and soft tissue at a surgical site within a patient, the ablation device comprising:

a probe configured to generate pressure and temperature for ablating the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient, the probe comprising at least two prongs, each prong of the at least two prongs including at least an exterior surface and a distal tip, each prong of the at least two prongs being configured to control at least a temperature of each respective exterior surface to achieve an ablation temperature on each respective exterior surface, the ablation temperature being adapted to ablate the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient; and

at least one monitoring device coupled to the probe for recording and regulating temperature, pressure and position of the probe;

wherein the distal tips of at least two prongs are configured to define, in combination, a probe geometry substantially matching an anatomical tissue geometry of the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient.

2. An ablation device according to claim 1, further comprising at least one imaging device coupled to the probe for identifying the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient.

3. An ablation device according to claim 1, wherein the at least one monitoring device is configured to detect differences between motor neurons, sensory neurons and/or interneurons.

4. An ablation device according to claim 2, further comprising a computer system coupled to the probe, the computer system programmed with software adapted to receive real time or retrospective time data from one of the at least one monitoring device and at least one imaging device to calculate optimal temperature, pressure, and position for the probe and for the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient.

5. An ablation device according to claim 1, wherein the at least two prongs are spaced apart and substantially parallel to each other, each prong of the at least two prongs further comprising an interior surface;

an internal passage disposed in the interior surface; and

a filament disposed in the internal passage, the filament having an opening configured to release a pressurized material into each interior surface, the pressurized material adapted to control the temperature of each respective exterior surface of the at least two prongs to achieve the ablation temperature of the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient.

6. An ablation device according to claim 1, wherein the at least one monitoring device comprises at least one of a battery, an electrode, a recharger, a transmitter, a receiver, a transceiver, a sensor, a recorder, a capacitor, a transformer, a system control unit, a programmer, an address/positioning unit, a temperature sensor, a temperature adjuster, a thermogenerator, a thermoelectric generator, a pressure sensor, a pressure adjuster, a mechanical power generator, a photo/light generator, an ultraviolet light generator, an infrared generator, an optical stimulator, a laser, a radiofrequency generator, a magnetic field generator, a mechanical vibration generator, an ultrasonic wave generator, an electrical field generator, a radiation generator and a fuel cell.

7. An ablation device according to claim 2, wherein the at least one imaging device comprises at least one of an ultrasound device, an overhead 3D stereotactic system, a Magnetic Resonance Imaging (MRI) device, a functional Magnetic Resonance Imaging (fMRI) device, a Magnetic Resonance Spectroscopy (MRS) device, a diffusion MRI (DWI) device, a diffusion tensor MRI (DTI) device, an electroencephalography (EEG), magnetoencephalography (MEG) device, a nuclear neuroimaging device, a positron emission tomography (PET) device, a single photon emission computed tomography (SPECT) device, an Ictal-Interictal SPECT Analysis by Statistical Parametric Mapping (ISAS) device, a Computed Tomography (CT) device, an x-ray device, a fluoroscopy, an angiography device, an ultrasonography device, a transcranial magnetic stimulation (TMS) device, a transcranial direct current stimulation (tDCS) device, a transcranial electrical stimulation (TES) device, a motor evoked potential (MEP) device, a somatosensory evoked potential (SSEP) device, a phase reversal of somatosensory evoked potential device, an evoked potential device, an electrocorticography (ECoG) device, a direct cortical electrical stimulation (DCES) device, a microelectrode recording (MER) device, and a local field potential recording (LFP) device.

8. An ablation device according to claim 1, wherein at least one prong of the at least two prongs has a substantial shape of a needle from about 16 to about 22 gauge.

9. An ablation device according to claim 6, wherein at least one prong of the at least two prongs comprises one of a substantially beveled end and a substantially hemispherical end.

10. An ablation device according to claim 1, wherein the end of at least one prong of the at least two prongs comprises a deployable balloon configured to one of exert pressure on surrounding tissue and increase surface area coverage of diffuse nerve fibers at the surgical site in the patient.

11. An ablation device according to claim 5, wherein the pressurized material comprises at least one of argon, liquid nitrogen, nitric oxide, helium, air, krypton, carbon dioxide, tetrafluoromethane, xenon and a combination thereof.

12. An ablation device according to claim 1, wherein the respective exterior surface of at least one prong of the at least two prongs further comprises an opening, the opening being configured for release of a substance useful in monitoring or navigating the probe.

21. An ablation device according to claim 1, wherein the at distal tips of the least two prongs of the ablation probe are further configured, in combination, to define a plurality of anatomical tissue geometries within the patient.

22. An ablation device according to claim 1, wherein the at least two prongs of the ablation probe are configured to be inserted at a certain depth into the patient to ablate the unwanted one of the nerve tissue and the soft tissue at a portion of the surgical site within the patient.

23. An ablation device according to claim 1, wherein the at least two prongs of the ablation probe further comprise at least three prongs.

24. An ablation device according to claim 1, wherein the at least two prongs of the ablation probe are configured to cool the respective exterior surface to the ablation temperature of the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient.

25. An ablation device according to claim 1, wherein each prong of the at least two prongs of the ablation probe is further configured to form an ice ball at the respective distal tip.

13. A method for ablating unwanted one of soft tissue and nerve tissue at a surgical site within a patient, the method comprising:

positioning at least one ablation probe, the at least one ablation probe coupled with one of at least one monitoring device and at least one imaging device, at a location near the unwanted one of the soft tissue and the nerve tissue, the ablation probe comprising at least two prongs, each prong of the at least two prongs comprising at least an exterior surface and a distal tip, and each prong of the at least two prongs being configured to control at least a temperature of each respective exterior surface to achieve an ablation temperature on each respective exterior surface, the ablation temperature being adapted to ablate the unwanted one of the soft tissue and the nerve tissue, the distal tips of the at least two prongs being configured to define, in combination, a probe geometry substantially matching an anatomical tissue geometry of the unwanted one of the soft tissue and the nerve tissue;

identifying a location of the unwanted one of the soft tissue and the nerve tissue from an input of the one of the at least one monitoring device and the at least one imaging device;

confirming the location of the unwanted one of the soft tissue and the nerve tissue from the input of the one of the at least one monitoring device and the at least one imaging device;

applying the at least one ablation probe to the confirmed location of the unwanted one of the soft tissue and the nerve tissue; and

confirming the ablation of the unwanted one of the soft tissue and the nerve tissue.

14. A method according to claim 13 further comprising providing a computer programmed with software for accepting the input from the at least one monitoring device and computing an optimal temperature, pressure and location for the ablation probe.

15. A method according to claim 13, wherein confirming the location of the unwanted one of the soft tissue and the nerve tissue and confirming the ablation of the unwanted one of the soft tissue and the nerve tissue comprises using one of non-ablative temperature and pressure based upon one of patient feedback and input from the one of the at least one monitoring device and the at least one imaging device.

16. A method according to claim 13, wherein the unwanted one of the soft tissue and the nerve tissue comprises neurons responsible for pain affecting at least one of bones, soft tissues, joints, and cavities.

17. A method of claim 13, wherein the at least two prongs are spaced apart and substantially parallel to each other, each prong of the at least two prongs each further comprising an interior surface;

an internal passage disposed in the interior surface; and

a filament disposed in the internal passage of the at least two prongs, the filament having an opening configured to release a pressurized material into the interior surface of the at least two prongs so as to control the temperature of each respective exterior surface to reach the ablation temperature of the unwanted one of the soft tissue and the nerve tissue at the surgical site within the patient.

18. A method according to claim 17, wherein the exterior surface of each prong of the at least two prongs contacts the unwanted one of the nerve tissue and the soft tissue to form an ice ball proximate each respective distal tip, the ice ball being configured for ablating the unwanted one of the nerve tissue and the soft tissue;

wherein each ice ball forms in about 2-8 minutes, wherein at least a portion of each ice ball one of comes into contact with and overlaps the unwanted one of the nerve tissue and the soft tissue, thereby causing the unwanted one of the nerve tissue and the soft tissue to be ablated, wherein a temperature of the pressurized material decreases proximate the distal tip, and wherein the pressurized material is cooled proximate the distal tip to a temperature of about 0 degrees C. to about −

160degrees C. or cooler.

20. A method of ablation of claim 18, wherein the at least two prongs of the ablation probe are applied simultaneously.

19. A method for ablating unwanted one of soft tissue and nerve tissue at a surgical site within a patient, the method comprising:

positioning an ablation probe, the ablation probe comprising at least two prongs coupled to each other, each prong of the at least two prongs comprising at least an exterior surface and a distal tip, each prong of the at least two prongs being configured to control at least a temperature of the respective exterior surface to achieve an ablation temperature the ablation temperature on each respective exterior surface being adapted to ablate the unwanted one of the nerve tissue and the soft tissue at the surgical site within the patient, the distal tips of the at least two prongs being configured to define, in combination, a probe geometry substantially matching an anatomical tissue geometry of the unwanted one of the soft tissue and the nerve tissue; and

one of at least one monitoring device and at least one imaging device at a location proximate the unwanted one of the soft tissue and the nerve tissue;

identifying the location of the unwanted one of the soft tissue and the nerve tissue from an input of the one of the at least one monitoring device and the at least one imaging device;

confirming the location of the unwanted one of the soft tissue and the nerve tissue from the input of the one of the at least one monitoring device and the at least one imaging device;

applying the at least two prongs of the ablation probe to the confirmed location of the unwanted one of the soft tissue and the nerve tissue; and

confirming the ablation of the unwanted one of the soft tissue and the nerve tissue.