# US 10,441,339 B2 · Spinal tissue ablation apparatus, system, and method

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- Number: US 10,441,339 B2
- Document ID: US10441339B2
- Status: Granted
- Kind: B2
- Application number: 14/943,264
- Filed: 2015-11-17
- Published: 2017-05-18
- Granted: 2019-10-15
- Earliest claimed: 2015-11-17
- Assignees: Medtronic Holding Company SàRl
- Applicants: Medtronic Holding Company Sàrl
- Inventors: Stephen W. Lee; Michael A. Smith; Dawud F. Dueiri
- Web page: https://patentgrep.com/patent/US10441339B2

## CPC

- A61B 18/082: {Probes or electrodes therefor}
- A61B 18/10: Power sources therefor
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00041: {Heating, e.g. defrosting}
- A61B 2018/00339: {Spine, e.g. intervertebral disc}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/0072: {Current}
- A61B 2018/00744: {Fluid flow}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00875: {Resistance or impedance}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Flexible apparatus for ablating unhealthy spinal tissue. A housing includes a distal end and a proximal end. Multiple thermocouples mounted on the housing measure spinal tissue temperatures at locations between the proximal end and the distal end. A sensor measures spinal tissue impedance. The measured spinal tissue impedance corresponds to various physical state data of the spinal tissue. The spinal tissue impedance and the spinal tissue temperatures are displayed to the surgeon, enabling the surgeon to determine with certainty the location of the unhealthy spinal tissue, and to exercise control over the ablation apparatus. Nerve stimulation by IMP/STM switch system to detect nerve responses before and after treatment.

## Claims

### Claim 1

A spinal tissue ablation apparatus comprising:
an elongated housing, the housing including an outer surface, an inner surface, an interior space defined by the inner surface, a proximal end and a distal end, the proximal end and the distal end defining therebetween a mid-longitudinal axis;
an anode defined on the outer surface at the distal end of the housing, the anode including an outer surface and an inner surface;
at least one thermocouple disposed on the outer surface of the housing, the at least one thermocouple being configured to measure a temperature of spinal tissue proximate the at least one thermocouple;
a cathode defined on the outer surface of the housing, intermediate the distal end and the proximal end;
a cooling system disposed at least partially within the interior space;
at least a first layer of resistive heating elements substantially encircling at least a portion of the outer surface of the housing relative to the mid-longitudinal axis, the at least the first layer of the resistive heating elements extending in a proximal direction from a first position proximate the cathode to a second position intermediate the first position and the proximal end of the housing;
at least a second layer of resistive heating elements, the at least the second layer of resistive heating elements substantially encircling, relative to the mid-longitudinal axis, at least one of a portion of the at least the first layer of resistive heating elements extending from between the first position to the second position intermediate the first position and the proximal end, a portion of the at least the first layer of resistive heating elements extending from the first position to a third position intermediate the first position and the second position, a portion of the at least the first layer of resistive heating elements extending from the second position to a fourth position intermediate the first position and the second position; and
at least one sensor mounted on the outer surface of the housing, the at least one sensor configured to measure tissue impedance proximate the at least one sensor.

### Claim 2 (depends on 1)

An apparatus as recited in claim 1, wherein the at least one thermocouple includes a first thermocouple, the first thermocouple being disposed on the housing proximate the distal end.

### Claim 3 (depends on 2)

An apparatus as recited in claim 2, wherein the at least one thermocouple includes a second thermocouple, the second thermocouple being disposed in an integrated position within the at least the first layer of resistive heating elements.

### Claim 4 (depends on 3)

An apparatus as recited in claim 3, wherein the at least one thermocouple includes a third thermocouple, the third thermocouple being disposed on the housing proximate the proximal end.

### Claim 5 (depends on 4)

An apparatus as recited in claim 4, wherein the apparatus is configured, during insertion of the apparatus into a patient's disc space, between two vertebral bodies, to position the third thermocouple proximate the patient's spinal cord.

### Claim 6 (depends on 1)

An apparatus as recited in claim 1, wherein the at least one sensor is mounted on the distal end of the housing proximate the cathode and the anode.

### Claim 7 (depends on 1)

An apparatus as recited in claim 1, wherein the cooling system includes a recirculating water system.

### Claim 8 (depends on 1)

An apparatus as recited in claim 1, further comprising at least one elongated layer positioned between the inner surface and the interior space.

### Claim 9 (depends on 8)

An apparatus as recited in claim 8, further comprising an elongated air-filled gap defined between the at least one layer and the inner surface, the air-filled gap being configured to provide flexibility to the housing.

### Claim 10 (depends on 1)

An apparatus as recited in claim 1, further comprising a shield portion defined on the outer surface of the housing, the shield portion extending in the proximal direction from the first position, the shield portion being configured to enclose the at least the first layer and the at least the second layer of the resistive heating elements.

### Claim 11 (depends on 1)

An apparatus as recited in claim 1, wherein the housing includes a flexible material.

### Claim 12

A system for ablating unhealthy spinal tissue at a surgical site in a patient comprising:
a spinal tissue ablation apparatus, the apparatus comprising:
an elongated housing, the housing including an outer surface, an inner surface, an interior space defined by the inner surface, a proximal end and a distal end, the proximal end and the distal end defining therebetween a mid-longitudinal axis, a proximal direction and a distal direction;
an anode defined on the outer surface at the distal end of the housing, the anode including an outer surface and an inner surface;
at least one thermocouple disposed on the outer surface of the housing, the at least one thermocouple being configured to measure a temperature of spinal tissue proximate the at least one thermocouple;
a cathode defined on the outer surface of the housing, intermediate the distal end and the proximal end;
a cooling system disposed at least partially within the interior space;
at least a first layer of resistive heating elements substantially encircling at least a portion of the outer surface of the housing relative to the mid-longitudinal axis, the at least the first layer of the resistive heating elements extending in a proximal direction from a first position proximate the cathode to a second position intermediate the first position and the proximal end of the housing;
at least a second layer of resistive heating elements, the at least the second layer of resistive heating elements substantially encircling, relative to the mid-longitudinal axis, at least one of a portion of the at least the first layer of resistive heating elements extending from between the first position to the second position intermediate the first position and the proximal end, a portion of the at least the first layer of resistive heating elements extending from the first position to a third position intermediate the first position and the second position, a portion of the at least the first layer of resistive heating elements extending from the second position to a fourth position intermediate the first position and the second position; and
at least one sensor mounted on the outer surface of the housing, the at least one sensor configured to measure tissue impedance proximate the at least one sensor; and
a power generator, the power generator including at least a detector, the detector being configured to receive the spinal tissue impedance measured by the at least one sensor, and the spinal tissue temperature measured by the at least one thermocouple, a control module, a touch screen display, the touch screen display being configured to display the spinal tissue impedance data, and the spinal tissue temperature, and a human interface panel, the human interface panel configured to control at least one of electric current to the at least the first layer of resistive heating elements and coolant flow to the cooling system.

### Claim 13 (depends on 12)

A system as recited in claim 12, wherein the cooling system includes a recirculating water system.

### Claim 14 (depends on 12)

A system as recited in claim 12, further comprising at least one elongated layer positioned between the inner surface and the interior space.

### Claim 15 (depends on 14)

A system as recited in claim 14, further comprising an elongated air-filled gap defined between the at least one elongated layer and the inner surface, the air-filled gap being configured to provide flexibility to the housing.

### Claim 16 (depends on 12)

A system as recited in claim 12, wherein the at least one thermocouple includes a first thermocouple, the first thermocouple being disposed on the housing proximate the distal end.

### Claim 17 (depends on 16)

A system as recited in claim 16, wherein the at least one thermocouple further includes a second thermocouple, the second thermocouple being disposed in an integrated position within the at least a first layer of resistive heating elements.

### Claim 18 (depends on 17)

A system as recited in claim 17, wherein the at least one thermocouple further includes a third thermocouple, the third thermocouple being disposed on the housing proximate the proximal end.

### Claim 19 (depends on 12)

A system as recited in claim 12, further comprising a shield portion defined on the outer surface of the housing, the shield portion extending in the proximal direction from the first position proximate the cathode to the second position intermediate the first position and the distal end, the shield portion being configured to enclose the at least the first layer and the at least the second layer of the resistive heating elements.

### Claim 20 (depends on 12)

A system as recited in claim 12, wherein the housing includes a flexible material.

### Claim 21

A spinal tissue ablation apparatus comprising:
an elongated housing, the housing including an outer surface, an inner surface, an interior space defined by the inner surface, a proximal end and a distal end, the proximal end and the distal end defining therebetween a mid-longitudinal axis;
an anode provided on the outer surface at and/or adjacent the distal end of the housing;
at least one thermocouple provided on the outer surface of the housing for measuring a temperature of spinal tissue proximate the at least one thermocouple;
a cathode provided on the outer surface of the housing intermediate the distal end and the proximal end;
a cooling system disposed at least partially within the interior space;
a first layer of resistive heating elements substantially encircling at least a portion of the outer surface of the housing relative to the mid-longitudinal axis, the first layer of the resistive heating elements extending between a first position proximate the cathode to a second position intermediate the first position and the proximal end of the housing;
a second layer of resistive heating elements, the second layer of resistive heating elements substantially encircling, relative to the mid-longitudinal axis, at least one of a portion of the first layer of resistive heating elements extending from between the first position to the second position intermediate the first position and the proximal end, a portion of the first layer of resistive heating elements extending from the first position to a third position intermediate the first position and the second position, a portion of the first layer of resistive heating elements extending from the second position to a fourth position intermediate the first position and the second position; and
at least one sensor provided on the outer surface of the housing for measuring tissue impedance proximate the at least one sensor.

### Claim 22 (depends on 21)

An apparatus as recited in claim 21, wherein the at least one thermocouple includes a first thermocouple, the first thermocouple being provided on the housing proximate the distal end.

### Claim 23 (depends on 22)

An apparatus as recited in claim 22, wherein the at least one thermocouple includes a second thermocouple, the second thermocouple being disposed in an integrated position within the at least the first layer of resistive heating elements.

### Claim 24 (depends on 23)

An apparatus as recited in claim 23, wherein the at least one thermocouple includes a third thermocouple, the third thermocouple being provided on the housing proximate the proximal end.

### Claim 25 (depends on 24)

An apparatus as recited in claim 24, wherein the apparatus is configured, during insertion of the apparatus into a patient's disc space, between two vertebral bodies, to position the third thermocouple proximate the patient's spinal cord.

### Claim 26 (depends on 21)

An apparatus as recited in claim 21, wherein the at least one sensor is provided on the distal end of the housing proximate the cathode and the anode.

### Claim 27 (depends on 21)

An apparatus as recited in claim 21, wherein the cooling system includes a recirculating water system.

### Claim 28 (depends on 21)

An apparatus as recited in claim 21, further comprising at least one elongated layer positioned between the inner surface and the interior space.

### Claim 29 (depends on 28)

An apparatus as recited in claim 28, further comprising an elongated air-filled gap defined between the at least one layer and the inner surface.

### Claim 30 (depends on 21)

An apparatus as recited in claim 21, further comprising a shield portion defined on the outer surface of the housing, the shield portion extending in the proximal direction from the first position, the shield portion being configured to enclose the first layer and the second layer of the resistive heating elements.

### Claim 31 (depends on 21)

An apparatus as recited in claim 21, wherein the housing includes a flexible material.
