# US 9,039,701 B2 · Channeling paths into bone

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- Number: US 9,039,701 B2
- Document ID: US9039701B2
- Status: Granted
- Kind: B2
- Application number: 13/963,767
- Filed: 2013-08-09
- Published: 2013-12-05
- Granted: 2015-05-26
- Earliest claimed: 2008-09-26
- Assignees: Relievant Medsystems, Inc.
- Applicants: Relievant Medsystems, Inc.
- Inventors: Richard Pellegrino; Samit Patel; Harold Carrison
- Web page: https://patentgrep.com/patent/US9039701B2

## CPC

- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/16: Instruments for performing osteoclasis; Drills or chisels for bones; Trepans {(arthroscopic bone cutters A61B17/320016)}
- A61B 17/1642: {for producing a curved bore}
- A61B 17/1671: {for the spine}
- A61B 17/34: Trocars; Puncturing needles
- A61B 17/3403: {Needle locating or guiding means}
- A61B 17/3421: {Cannulas}
- A61B 17/8819: {characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula (A61B17/8825 takes precedence)}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy}
- A61B 18/1487: {Trocar-like, i.e. devices producing an enlarged transcutaneous opening}
- A61B 18/149: {bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61B 18/1815: {using microwaves}
- A61B 18/20: using laser
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B 18/0206: {ultrasonic, e.g. for destroying tissue or enhancing freezing}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2018/00011: {with fluids}
- A61B 2018/00017: {with gas}
- A61B 2018/00339: {Spine, e.g. intervertebral disc}
- A61B 2018/00434: {Neural system}
- A61B 2018/00577: {Ablation}
- A61N 2007/0026: {Stimulation of nerve tissue}
- A61N 2007/025: {interstitial}
- 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

System and methods are shown having a tube-within-tube assembly with a deployable curved deflectable tube or cannula that deploys from a straight cannula or trocar. The curved cannula has a pre-curved distal end to create an angular range of 0° to 180° when fully deployed from the straight trocar. The curve is configured such that the flexible element carrying a treatment device can navigate through the angular range of deployment of the curved cannula. The curved cannula allows the flexible element to navigate through a curve within bone without veering off towards an unintended direction.

## Claims

### Claim 1

A method for channeling a path into bone to a treatment location in a body of a patient, comprising:
inserting an introducer into a region of the bone near the treatment location, the introducer having a central channel and an opening at a distal tip of the introducer;
delivering a curved cannula through said central channel of said introducer to said opening,
wherein a proximal portion of the curved cannula comprises a locking nut to control advancement of the curved cannula with respect to the introducer,
wherein the curved cannula comprises a deflectable distal tip having a preformed curve such that the deflectable distal tip straightens while being delivered through the introducer and transitions to a curved configuration upon exiting the introducer,
wherein the deflectable distal tip of the curved cannula is configured to arc to an angle of between 5 degrees and 90 degrees;
moving the locking nut to a position such that the locking nut is in contact with a proximal end of the curved cannula, thereby allowing the deflectable distal tip of the curved cannula to be advanced past the opening at the distal tip of the introducer and to transition to the curved configuration;
extending the curved cannula past the opening at the distal tip of the introducer to generate a curved path in the bone corresponding to the preformed curve of the deflectable distal tip;
inserting a channeling stylet into the curved cannula,
wherein the channeling stylet is flexibly deformable to navigate the curved cannula yet rigid enough to retain a straight form upon exiting the deflectable distal tip of the curved cannula;
creating a linear channel starting at a distal end of the curved path formed by the curved cannula by extending a distal end of the channeling stylet out of the deflectable distal tip of the curved cannula;
removing the channeling stylet from the curved cannula; and
delivering a treatment device through said curved cannula to the treatment location through the linear channel.

### Claim 2 (depends on 1)

The method of claim 1, wherein inserting the introducer into the region of bone comprises:
inserting a stylet into the introducer such that the stylet extends beyond the opening of the introducer;
inserting the stylet and the introducer simultaneously into the region of bone such that the stylet pierces the bone as the introducer is being delivered to the treatment location.

### Claim 3 (depends on 1)

The method of claim 1, wherein delivering the curved cannula through the central channel comprises:
inserting a straightening stylet into a central passageway of the curved cannula; the straightening stylet comprising a rigid construction configured to straighten the deflectable distal tip of the curved cannula;
inserting the straightening stylet and the curved cannula simultaneously into the introducer; and
removing the straightening stylet from the curved cannula.

### Claim 4 (depends on 3)

The method of claim 3:
wherein the straightening stylet further comprises a sharp distal end to pierce the bone;
wherein the sharp distal end extends beyond a distal opening of the curved cannula; and
wherein the straightening stylet and the curved cannula are installed simultaneously along with the introducer as the introducer is delivered into the bone.

### Claim 5 (depends on 1)

The method of claim 1, wherein extending the curved cannula past the opening at the distal tip of the introducer comprises:
inserting a curved stylet into a central passageway of the curved cannula such that a distal tip of the curved stylet extends to at least a distal opening of the curved cannula; and
simultaneously extending the curved cannula and the curved stylet from the distal end of the introducer such that the curved stylet blocks the distal opening of the curved cannula while being delivered into the bone.

### Claim 6 (depends on 5)

The method of claim 5, further comprising removing the curved stylet from the curved cannula.

### Claim 7 (depends on 1)

The method of claim 1, wherein the treatment location corresponds to a location of a portion of a basivertebral nerve of a vertebra, the method further comprising:
delivering treatment to the treatment location to denervate at least the portion of the basivertebral nerve.

### Claim 8 (depends on 7)

The method of claim 7, wherein denervating the portion of the basivertebral nerve comprises delivering focused, therapeutic heating to the treatment location.

### Claim 9 (depends on 7)

The method of claim 7, wherein denervating the portion of the basivertebral nerve comprises delivering an agent to the treatment location.

### Claim 10 (depends on 7)

The method of claim 7, wherein the treatment location corresponds to the location of the portion of the basivertebral nerve that is downstream of one or more branches of the basivertebral nerve.

### Claim 11 (depends on 7)

The method of claim 7, wherein delivering treatment to the treatment location to denervate at least the portion of the basivertebral nerve comprises delivering radiofrequency energy to the treatment location to denervate at least the portion of the basivertebral nerve.

### Claim 12 (depends on 7)

The method of claim 7, wherein delivering treatment to the treatment location to denervate at least the portion of the basivertebral nerve comprises delivering ultrasonic energy to the treatment location to denervate at least the portion of the basivertebral nerve.

### Claim 13

A method for channeling a path into vertebral bone to a treatment location in a body of a patient, comprising:
providing an energy delivery system, said energy delivery system comprising an introducer, a curved cannula, a channeling stylet, and an energy delivery probe;
inserting the introducer through a pedicle and into a cancellous bone region of the vertebral bone near the treatment location,
wherein the introducer has a central channel along its longitudinal axis and an axial opening at a distal tip of the introducer;
delivering the curved cannula through said central channel of said introducer to said axial opening at the distal tip of the introducer,
wherein a proximal end of the curved cannula comprises a locking nut to control advancement of the curved cannula with respect to the introducer,
wherein the curved cannula comprises a deflectable distal tip having a preformed curved configuration such that the deflectable distal tip straightens while being delivered through the central channel of the introducer and curves again upon exiting the axial opening of the introducer;
extending the curved cannula past the axial opening at the distal tip of the introducer to generate a curved path toward the treatment location corresponding to the preformed curved configuration of the deflectable distal tip of the curved cannula,
wherein the curved cannula is extended through at least a portion of the cancellous bone region to a location near the treatment location,
wherein the deflectable distal tip of the curved cannula is configured to arc to an angle between 5 degrees and 110 degrees;
creating a linear channel starting at a distal end of the curved path formed by the curved cannula by inserting the channeling stylet within the curved cannula and extending a distal end of the channeling stylet out of the deflectable distal tip of the curved cannula,
wherein the channeling stylet is flexibly deformable to navigate the curved cannula yet rigid enough to retain a straight form upon exiting the deflectable distal tip of the curved cannula;
removing the channeling stylet from the curved cannula;
delivering the energy delivery probe through a central passageway in said curved cannula to the treatment location through the linear channel; and
activating the energy delivery probe at the treatment location to deliver energy to the treatment location.

### Claim 14 (depends on 13)

The method of claim 13, wherein the treatment location comprises an intraosseous nerve of the vertebral bone.

### Claim 15 (depends on 13)

The method of claim 13, wherein the treatment location comprises a basivertebral nerve of the vertebral bone.

### Claim 16 (depends on 15)

The method of claim 15, wherein the energy delivery probe comprises a radiofrequency ablation probe and wherein the step of activating the energy delivery probe at the treatment location to deliver energy to the treatment location comprises applying radiofrequency energy sufficient to denervate at least a portion of the basivertebral nerve at the treatment location.

### Claim 17 (depends on 15)

The method of claim 15, wherein the energy delivery probe comprises an ultrasonic ablation probe and wherein the step of activating the energy delivery probe at the treatment location to deliver energy to the treatment location comprises applying ultrasonic energy sufficient to denervate at least a portion of the basivertebral nerve at the treatment location.

### Claim 18 (depends on 15)

The method of claim 15, wherein the treatment location is posterior to a basivertebral nerve junction.

### Claim 19 (depends on 13)

The method of claim 13, wherein the step of inserting the introducer through the pedicle and into the cancellous bone region of the vertebral bone near the treatment location comprises:
inserting a stylet into the introducer such that the stylet extends beyond the axial opening of the introducer; and
inserting the stylet and the introducer simultaneously into the vertebral bone such that the stylet pierces cancellous bone within the cancellous bone region as the introducer is being delivered toward the treatment location.

### Claim 20 (depends on 13)

The method of claim 13, wherein the step of extending the curved cannula past the axial opening at the distal tip of the introducer comprises:
inserting a curved stylet into the central passageway of the curved cannula such that a distal tip of the curved stylet extends to at least a distal opening of the curved cannula; and
simultaneously extending the curved cannula and the curved stylet from the distal end of the introducer such that the curved stylet blocks the distal opening of the curved cannula while being delivered into the vertebral bone.
