# US 10,369,338 B2 · Expandable tissue dilator for dilating tissue around a spinal column

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- Number: US 10,369,338 B2
- Document ID: US10369338B2
- Status: Granted
- Kind: B2
- Application number: 15/269,081
- Filed: 2016-09-19
- Published: 2017-08-24
- Granted: 2019-08-06
- Earliest claimed: 2016-02-23
- Assignees: Globus Medical, Inc.
- Applicants: Globus Medical, Inc.
- Inventors: Andrew Berkowitz; Brian Flint
- Web page: https://patentgrep.com/patent/US10369338B2

## CPC

- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 17/3421: {Cannulas}
- A61M 2210/1003: Spinal column
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An expandable tissue dilator for dilating tissue around a spinal column includes a housing and a shaft at least partially positioned distally of the housing and adapted to pierce a tissue around the spinal column. An expandable member attached to the housing expands around a portion of the shaft to dilate the pierced tissue in a single-pass dilation resulting in a reduction of any traumatic impingement of nerves or muscle tissue and reduction in procedure time.

## Claims

### Claim 1

An expandable tissue dilator for dilating tissue around a spinal column, comprising:
a shaft having a proximal end and a distal end;
an expandable balloon disposed on the distal end of the shaft, the balloon having a proximal neck region and a distal neck region and wherein the expandable balloon is configured to expand to a predetermined shape and dimension upon receiving a fluid;
an inner tube disposed inside the shaft and attached to the expandable balloon at the distal neck region, wherein the inner tube is configured to receive a guidewire;
an outer tube that at least partially surrounds the inner tube whereby a space is disposed in between the outer tube and the inner tube and wherein the outer tube is attached to expandable balloon at the proximal neck region; and
a hub comprising an off-set chamber, wherein the off-set chamber is completely disposed inside the hub off-center from a longitudinal axis of the dilator without intersecting the guide wire,
wherein the expandable balloon is configured to receive the fluid via the space between the inner tube and the outer tube.

### Claim 2 (depends on 1)

The expandable tissue dilator of claim 1, wherein the expandable balloon is a non-compliant balloon.

### Claim 3 (depends on 1)

The expandable tissue dilator of claim 1, wherein the hub is disposed at the proximal end of the shaft and configured to receive the inner tube and the outer tube.

### Claim 4 (depends on 1)

The expandable tissue dilator of claim 1, wherein the expandable balloon is configured to expand such that a diameter of the expandable balloon in an expanded position is substantially the same as a diameter of the shaft.

### Claim 5 (depends on 3)

The expandable tissue dilator of claim 3, wherein the hub comprises a central chamber, wherein the central chamber and the offset chamber intersect in order to allow fluid flow to the expandable balloon.

### Claim 6 (depends on 1)

The expandable tissue dilator of claim 1, further comprising a luer connector configured to receive the fluid from an external inflation device, wherein the luer connector is further attached to the hub in to provide the fluid to the expandable balloon.

### Claim 7 (depends on 1)

The expandable tissue dilator of claim 1, further comprising a switch that is configured to move between an open position and a closed position, wherein pressure within the expandable balloon is maintained when the switch is at the closed position.

### Claim 8 (depends on 7)

The expandable tissue dilator of claim 7, wherein the switch is configured to move an occulating ball to press against a flexible tube within the hub to maintain pressure within the expandable balloon.

### Claim 9 (depends on 1)

The expandable tissue dilator of claim 1, wherein the inner tube contains an insulated middle region, an uninsulated proximal region, and an uninsulated distal region, wherein the inner tube is further configured to provide neuromonitoring capabilities after insertion into a patient.

### Claim 10

An expandable tissue dilator for dilating tissue around a spinal column, comprising:
a shaft having a proximal end and a distal end;
an expandable balloon disposed on the distal end of the shaft, the balloon having a proximal neck region and a distal neck region and wherein the expandable balloon is configured to expand to a predetermined shape and dimension upon receiving a fluid;
an inner tube disposed inside the shaft and attached to the expandable balloon at the distal neck region, wherein the inner tube is configured to receive a guidewire;
an outer tube attached to the expandable balloon at the proximal neck region, wherein the outer tube is disposed in a manner surrounding the inner tube and providing a space for receiving the fluid for expanding the expandable balloon;
a hub comprising an off-set chamber, wherein the off-set chamber is completely disposed inside the hub off-center from a longitudinal axis of the dilator without intersecting the guide wire,
wherein the inner tube is comprised of an electrically conductive material and is configured to indicate the presence of a nerve as the expandable dilator traverses through soft tissue of a patient.

### Claim 11 (depends on 10)

The expandable tissue dilator of claim 10, wherein the expandable balloon is a non-compliant balloon.

### Claim 12 (depends on 10)

The expandable tissue dilator of claim 10, wherein the hub is disposed at the proximal end of the shaft and configured to receive the inner tube and the outer tube.

### Claim 13 (depends on 12)

The expandable tissue dilator of claim 12, further comprising a luer connector configured to receive the fluid from an external inflation device, wherein the luer connector is further attached to the hub in to provide the fluid to the expandable balloon.

### Claim 14 (depends on 12)

The expandable tissue dilator of claim 12, wherein the hub comprises a central chamber, wherein the central chamber and the offset chamber intersect in order to allow fluid to flow to the expandable balloon.

### Claim 15 (depends on 10)

The expandable tissue dilator of claim 10, wherein the expandable balloon is configured to expand such that a diameter of the expandable balloon in an expanded position is substantially the same as a diameter of the shaft.

### Claim 16 (depends on 10)

The expandable tissue dilator of claim 10, further comprising a switch that is configured to move between an open position and a closed position, wherein pressure within the expandable balloon is maintained when the switch is at the closed position.

### Claim 17 (depends on 16)

The expandable tissue dilator of claim 16, wherein the switch is configured to move an occulating ball to press against a flexible tube within the hub to maintain pressure within the expandable balloon.

### Claim 18 (depends on 10)

The expandable tissue dilator of claim 10, wherein the inner tube contains an insulated middle region, an uninsulated proximal region, and an uninsulated distal region.
