# US 8,771,276 B2 · Systems and methods for forming a cavity in, and delivering curable material into, bone

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- Number: US 8,771,276 B2
- Document ID: US8771276B2
- Status: Granted
- Kind: B2
- Application number: 12/957,793
- Filed: 2010-12-01
- Published: 2012-06-07
- Granted: 2014-07-08
- Earliest claimed: 2010-12-01
- Assignees: CareFusion 2200, Inc.
- Applicants: Evan D. Linderman
- Inventors: Evan D. Linderman
- Web page: https://patentgrep.com/patent/US8771276B2

## CPC

- A61B 17/8855: {inflatable, e.g. kyphoplasty balloons}
- 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 17/1642: {for producing a curved bore}
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Methods of injecting curable material within a bone structure, such as vertebroplasty, include locating a distal end of an access cannula within the bone structure. A channel creating device is inserted into a cannula lumen. A distal segment of the channel creating device is distally advanced from cannula distal end and into the bone structure. A curved channel is created in the bone structure with the distally advancing distal segment. A distal portion of a cavity creating device is then inserted into the cannula lumen, with the distal portion including an expandable body carried by an elongated body. The distal portion is distally advanced, following a path of the curved channel. The expandable body is transitioned to the expanded state to form a cavity in the bone structure. Finally, curable material is delivered to the cavity.

## Claims

### Claim 1

A method of injecting curable material to a delivery site within a bone structure, the method comprising:
locating a distal end of an access cannula within the bone structure, the access cannula forming a lumen and defining a central axis; inserting a channel creating device into the lumen;
distally advancing a distal segment of the channel creating device from the distal end and into the bone structure;
creating a curved channel in the bone structure with the distally advancing distal segment, the curved channel defining a curve relative to the central axis; removing the channel creating device;
wherein the distal segment includes a shaft terminating at a distal tip, wherein a maximum outer diameter of the distal tip is greater than an outer diameter of the shaft, and further wherein the step of distally advancing the distal segment includes the distal tip boring through the bone structure;
inserting a distal portion of a cavity creating device into the lumen, the distal portion including an expandable body carried by an elongated body, the expandable body operable between a contracted state and an expanded state;
distally advancing the distal portion from the distal end, including the distal portion following a path of the curved channel; operating the expandable body to form a cavity in the bone structure, the cavity being open to the curved channel; and
delivering curable material to the cavity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the expandable body is a balloon.

### Claim 3 (depends on 2)

The method of claim 2, wherein operating the expandable body to form a cavity includes inflating the balloon.

### Claim 4 (depends on 1)

The method of claim 1, wherein the step of the distal portion following a path of the curved channel includes the distal portion deflecting in response to contact with a wall of the curved channel.

### Claim 5 (depends on 4)

The method of claim 4, wherein the wall of the curved channel is defined by the bone structure.

### Claim 6 (depends on 4)

The method of claim 4, wherein the elongated body of the distal portion is a flexible catheter.

### Claim 7 (depends on 1)

The method of claim 1, wherein the distal segment of the channel creating device has a shape memory characteristic and naturally assumes a curved shape in longitudinal extension.

### Claim 8 (depends on 7)

The method of claim 7, wherein the step of inserting the distal segment into the lumen includes the access cannula forcing the distal segment to deflect from the curved shape toward a straightened shape.

### Claim 9 (depends on 7)

The method of claim 7, wherein the step of distally advancing the distal segment includes at least a portion of the distal segment distal the distal end of the access cannula naturally reverting toward the curved shape.

### Claim 10 (depends on 1)

The method of claim 1, wherein the maximum outer diameter of the distal tip is less than a diameter of the access cannula lumen.

### Claim 11 (depends on 1)

The method of claim 1, wherein the distal tip is sharpened.

### Claim 12 (depends on 1)

The method of claim 1, wherein the distal tip is asymmetric relative to a centerline of the shaft.

### Claim 13 (depends on 1)

The method of claim 1, wherein the shaft is tubular and forms at least one port adjacent the tip, the further wherein the step of delivering curable material includes reintroducing the channel creating device into the access cannula and delivering the curable material through the at least one port.

### Claim 14 (depends on 1)

The method of claim 1, wherein the curved channel has a diameter commensurate with a maximum diameter of the distal tip, and further wherein the cavity is defined by a maximum dimension greater than the curved channel diameter.

### Claim 15 (depends on 1)

The method of claim 1, wherein the bone structure is a vertebrae.

### Claim 16 (depends on 1)

The method of claim 1, wherein the bone structure includes an outer wall surrounding cancellous bone, and further wherein the curved channel is created in the cancellous bone independent of any naturally-occurring pathways in the cancellous bone.
