Apparatus for delivery of reinforcing materials to bone

• US 9,724,147 B2
• Filed: 01/15/2016
• Issued: 08/08/2017
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US14/996,275
• Publication Number:
  US 20160128750A1
• Time in Patent Office: 571 Days
• Field of Search: 606 92- 94, 606 62- 68, 604 21, 600101, 600116, 600178, 623 2362, 623 2348, 623 2358
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure

Abstract

An apparatus and methods for delivery of reinforcing materials to a weakened or fractured bone is disclosed. An apparatus for delivering a reinforcing mixture to a bone including a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen capable of allowing a bone reinforcing mixture to pass therethrough; a balloon engaging the tube wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon; and at least one light guide extending through the tube into the balloon to guide a light into the balloon.

Claims

1. An apparatus for delivering a reinforcing mixture to a fractured bone of a wrist or a hand, resulting in a wrist reduction, the apparatus comprising:

a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen for passing a bone reinforcing mixture therethrough;

a balloon engaging the distal end of the tube, wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon;

at least one light guide extending through the tube into the balloon to guide a light into the balloon to cure the bone reinforcing mixture, and

a switch coupled to the at least one light guide, the switch being configured to control light guided by the light guide into the balloon to prevent inadvertent illumination of the bone reinforcing mixture,

wherein the balloon, when in the inflated state by the bone reinforcing mixture in a cavity of the fractured bone, aligns bone fragments of the fractured bone.

2. The apparatus of claim 1 further comprising a light source that provides light to the tube, the light source provides one of an ultraviolet light to the tube or a visible light to the tube.

3. The apparatus of claim 1 wherein an outer surface of the balloon includes a textured surface, such that the textured surface includes one or more shapes.

4. The apparatus of claim 3 wherein the one or more shapes of the textured surface is one of ridges, ribs or both.

5. The apparatus of claim 1 wherein an outer surface of the balloon includes bumps, such that the bumps are one of convex bumps, concave bumps or both.

6. The apparatus of claim 1 wherein an outer surface of the balloon is coated with one or more material, the material includes at least one of a drug, a bone glue, a protein such as a bone morphogenic protein or a growth factor substance.

7. The apparatus of claim 6 wherein the drug includes at least one of an infection preventative drug or an antibiotic treatment drug.

8. The apparatus of claim 1 wherein the balloon is encapsulated in an expandable metallic tube, the expandable metallic tube is capable of being split to provide a greater longitudinal strength than that of a length of the balloon.

9. The apparatus of claim 8 wherein the expandable metallic tube extends beyond an area of the fractured bone and into a healthy bone.

10. The apparatus of claim 1 wherein the balloon includes an outer wall and an inner wall so as to form a tube.

11. The apparatus of claim 10 further comprising a radial structural member engaging the balloon.

12. The apparatus of claim 11 wherein the balloon inflates as the bone reinforcing mixture enters the balloon under pressure, while simultaneously expanding the radial structural member inside the balloon.

13. The apparatus of claim 1 wherein the balloon includes a balloon wall that is composed of a plurality of layers.

14. The apparatus of claim 13 wherein the plurality of layers of the balloon wall include at least an outer layer, a core layer and an inner layer.

15. The apparatus of claim 14 wherein the outer layer having a first thickness, the outer layer includes at least a portion that absorbs moisture and expands, so as to expand to a second thickness.

16. An apparatus for delivering a reinforcing mixture to a fractured bone of a wrist or a hand, resulting in a wrist reduction, the apparatus comprising:

a catheter having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the catheter has at least one inner lumen for passing a reinforcing mixture therethrough;

a balloon extending from the distal end of the catheter, wherein the balloon begins to expand from a substantially deflated state to a substantially inflated state as the reinforcing mixture enters the balloon,

wherein the balloon expands to a shape so a proximal end and a distal end of the balloon have an inflated diameter that is larger than a diameter of a middle portion of the balloon;

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to cure the reinforcing mixture;

a light source coupled to the at least one light guide and configured to deliver light to the at least one light guide to cure the reinforcing mixture;

a switch coupled to the at least one light guide, the switch being configured to control the light guided by the light guide into the balloon to prevent inadvertent illumination of the bone reinforcing mixture; and

a junction connecting the catheter to the balloon, wherein the junction concentrates stress applied to the catheter at the junction,

wherein the balloon, when in the inflated state by the reinforcing mixture in a cavity of the fractured bone, aligns bone fragments of the fractured bone.

17. The apparatus of claim 16 wherein the junction includes at least one of a notch, a groove and a channel in the catheter, to form a pre-weakened area extending substantially around a circumference of the catheter, so as to separate the balloon from the catheter under at least a predetermined load.

18. The apparatus of claim 16 wherein the larger diameter of the balloon toward the distal end and the proximal end engage the bone beyond an area of the fractured bone.

19. A method for reinforcing a bone of a wrist or a hand comprising:

penetrating the bone to gain access to a cavity in the bone;

inserting a balloon engaging a distal end of a catheter into the cavity in the bone;

infusing a reinforcing mixture into the balloon through at least one lumen of the catheter, wherein the balloon expands to a shape so a proximal end and a distal end of the balloon have an inflated diameter that is larger than a diameter of a middle portion of the balloon;

activating a light source and delivering light from the light source to the balloon through at least one light guide to harden the reinforcing mixture in the balloon; and

controlling the light from the light source being delivered by the light guide with a switch coupled to the light guide to prevent inadvertent illumination of the reinforcing mixture.

20. The method of claim 19 further comprising encapsulating the balloon in an expandable metallic tube.

21. The method of claim 20, wherein the expandable metallic tube is capable of being split to provide a greater longitudinal strength than that of a length of the balloon.

22. The method of claim 19, wherein the balloon includes an outer wall and an inner wall so as to form a tube.

23. The method of claim 19 further comprising engaging the balloon with a radial structural member.

24. The method of claim 19 further comprising expanding a radial structure member while inflating the balloon as the bone reinforcing mixture enters the balloon under pressure.