# US 9,433,450 B2 · Systems and methods for internal bone fixation

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- Number: US 9,433,450 B2
- Document ID: US9433450B2
- Status: Granted
- Kind: B2
- Application number: 14/535,971
- Filed: 2014-11-07
- Published: 2015-03-05
- Granted: 2016-09-06
- Earliest claimed: 2006-11-10
- Assignees: IlluminOss Medical, Inc.
- Applicants: IlluminOss Medical, Inc.
- Inventors: Robert A. Rabiner; Dennis P. Colleran; Anthony W. O'Leary; Justin G. Dye; Mark A. Drew
- Web page: https://patentgrep.com/patent/US9433450B2

## CPC

- A61B 17/7291: {for small bones, e.g. in the foot, ankle, hand or wrist}
- A61B 17/68: Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)}
- A61B 17/7097: {Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants (disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444)}
- A61B 17/7275: {with expanding cylindrical parts}
- A61B 17/8816: {characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections}
- 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 17/8836: {for heating, cooling or curing of bone cement or fluid fillers}
- A61B 17/8833: {Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2090/306: {using optical fibres}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. According to aspects illustrated herein, there is provided a device for repairing a fractured bone that includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter having an inner void for passing at least one reinforcing material, and an inner lumen for accepting a light pipe, wherein a distal end of the inner lumen terminates in an optical lens; a conformable member releasably engaging the distal end of the delivery catheter, the conformable member moving from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light pipe and the at least one reinforcing material.

## Claims

### Claim 1

A device for repairing a weakened or fractured bone comprising:
a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter having an inner void for passing at least one reinforcing material;
a balloon portion releasably engaging the distal end of the delivery catheter, the balloon portion is expandable from a deflated state to an inflated state by adding the at least one reinforcing material into the balloon portion; and
an optical fiber including a core surrounded by a cladding, the optical fiber is sized to pass through an inner lumen of the delivery catheter and into the balloon portion;
wherein the core of the optical fiber is partially exposed along at least a portion of a length of the optical fiber such that, when the optical fiber is in the balloon portion, the optical fiber is configured to disperse a light energy along the portion of the length of the optical fiber to cure the at least one reinforcing material within the balloon portion.

### Claim 2 (depends on 1)

The device of claim 1, wherein the optical fiber transmits the light energy from a light source to the balloon portion in at least one oblique angle direction.

### Claim 3 (depends on 1)

The device of claim 1, wherein the optical fiber has one of an approximate wide 80 degree acceptance angle, an approximate 80 degree beam spread or some combination thereof.

### Claim 4 (depends on 1)

The device of claim 1, wherein the optical fiber has one of a transmission loss of less than approximately 1.5% per a foot of the length of the optical fiber, a bend radius minimum of approximately 6 times a diameter of the optical fiber or some combination thereof.

### Claim 5 (depends on 1)

The device of claim 1, wherein the optical fiber has one of a spectral transmission range of approximately 350 nm to approximately 800 nm, a refractive index core of approximately 1.48 or greater or some combination thereof.

### Claim 6 (depends on 1)

The device of claim 1, wherein the optical fiber has one of a numerical aperture of approximately 0.63, a temperature stability of up to approximately 90° C. or some combination thereof.

### Claim 7 (depends on 1)

The device of claim 1, wherein the length of the optical fiber is approximately 30 continuous meters or less.

### Claim 8 (depends on 1)

The device of claim 1, wherein the cladding is removed from the optical fiber to create a uniform design on a surface of the optical fiber to disperse light energy at the terminating face and along the length of the optical fiber in a uniform pattern.

### Claim 9 (depends on 1)

The device of claim 1, wherein the cladding is removed from the optical fiber to create a non-uniform design on a surface of the optical fiber to disperse light energy at the terminating face and along the length of the optical fiber in a non-uniform pattern.

### Claim 10 (depends on 9)

The device of claim 9, wherein the cladding is removed from the optical fiber to create two or more notches, such that each notch of the two or more notches is configured at an angle to the optical fiber, the angle including one of an approximate 30 degrees or greater, an approximate 45 degrees or less or an approximate 62.5 degrees.

### Claim 11 (depends on 10)

The device of claim 10, wherein the notch angles for the two or more notches include a plurality of notches having non-uniform angles or a plurality of notches having uniform angles.

### Claim 12 (depends on 1)

The device of claim 1, wherein at least a portion of an outer r surface of the balloon portion includes a compressive textured surface, the compressive textured surface including at least one of one or more rib, one or more ridge, one or more bump or some combination thereof.

### Claim 13 (depends on 12)

The device of claim 12, wherein the textured surface assists the inflated balloon portion to contact with the bone by grabbing a portion of a bone fragment or all portions of bone fragments of a fractured bone.

### Claim 14

A system for repairing a weakened or fractured bone comprising:
at least one reinforcing material curable by exposure to visible light, the at least one reinforcing material having a low viscosity liquid consistency;
a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter having an inner void for passing the at least one reinforcing material;
a balloon member releasably engaging the distal end of the delivery catheter,
wherein the balloon member is expandable from a deflated state to an inflated state by adding the at least one reinforcing material through the inner void of the delivery catheter into the balloon member;
a low pressure delivery system configured to deliver the at least one reinforcing material to the balloon member;
a light pipe including a core surrounded by a cladding, the light pipe sized to pass through an inner lumen of the delivery catheter and into the balloon member;
wherein the core of the light pipe is partially exposed along at least a portion of a length of the light pipe such that, the light pipe is configured to disperse the light along the portion of the length of the light pipe to cure the at least one reinforcing material within the balloon member.

### Claim 15

A method for repairing a weakened or fractured bone comprising:
accessing to a cavity of the bone;
providing a device for use in repairing the bone, the device comprising a delivery catheter having an inner void for passing at least one reinforcing material and an inner lumen for accepting a light pipe, the delivery catheter releasably engaging a balloon member;
positioning the balloon member in the cavity of the bone;
inserting the light pipe inside of the balloon member, wherein at least a distal portion of the light pipe is modified by removing a portion of a cladding surrounding the light pipe;
introducing the at least one reinforcing material through the inner void of the delivery catheter for infusing the reinforcing material within the balloon member, wherein the balloon member moves from a deflated state to an inflated state;
passing light through the light pipe so the light pipe disperses light energy inside the balloon member such that the at least one reinforcing material is hardened; and
releasing the hardened balloon member from the delivery catheter.

### Claim 16 (depends on 15)

The method of claim 15, wherein the distal portion of the light pipe disperses light energy at a terminating face and along a length of the light pipe in at least one oblique angle direction.

### Claim 17 (depends on 15)

The method of claim 15, wherein the cladding is removed from the light pipe to create a uniform design on a surface of the light pipe to disperse light energy at the terminating face and along the length of the light pipe in a uniform pattern.

### Claim 18 (depends on 15)

The method of claim 15, wherein the cladding is removed from the light pipe to create a non-uniform design on a surface of the light pipe to disperse light energy at the terminating face and along the length of the light pipe in a non-uniform pattern.

### Claim 19 (depends on 18)

The method of claim 18, wherein the cladding is removed from the optical fiber to create two or more notches, such that each notch of the two or more notches is configured at an angle to the optical fiber, the angle including one of an approximate 30 degrees or greater, an approximate 45 degrees or less or an approximate 62.5 degrees.

### Claim 20 (depends on 19)

The method of claim 19, wherein the notch angles for the two or more notches include a plurality of notches having non-uniform angles or a plurality of notches having uniform angles.