Apparatus for delivery of reinforcing materials to bone

• US 10,456,184 B2
• Filed: 07/20/2017
• Issued: 10/29/2019
• 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:
  US15/655,326
• Publication Number:
  US 20180036054A1
• Time in Patent Office: 831 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, the apparatus comprising:

a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has one or more inner lumens extending 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 a bone reinforcing mixture entering the balloon through a first lumen extending through the tube such that the substantially inflated state of the balloon can be adjusted to place the fractured bone in a correct orientation by inflating or deflating the balloon by altering an amount of the bone reinforcing mixture in the balloon due to the viscosity of the bone reinforcing mixture, the viscosity of the bone reinforcing mixture being 1000 cP or less; and

at least one fiber extending through a second lumen extending through the tube and into the balloon to guide a light into the balloon to cure the bone reinforcing mixture when the fractured bone has been placed in the correct orientation,

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

4. 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.

5. The apparatus of claim 1, wherein an outer surface of the balloon is coated with one or more materials, 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.

6. 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.

7. The apparatus of claim 6, wherein the expandable metallic tube extends beyond an area of the fractured bone and into a healthy bone.

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

9. The apparatus of claim 8, further comprising a radial structural member engaging the balloon.

10. The apparatus of claim 9, wherein the balloon inflates as the bone reinforcing mixture enters the balloon under pressure, while simultaneously expanding the radial structural member inside the balloon.

11. An apparatus for delivering a reinforcing mixture to a fractured bone, the apparatus comprising:

a catheter having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the catheter has one or more inner lumens extending therethrough for passing a reinforcing mixture and a light therethrough; and

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 through a first lumen extending through the catheter such that the substantially inflated state of the balloon can be adjusted to place the fractured bone in a correct orientation by inflating or deflating the balloon by altering an amount of the bone reinforcing mixture in the balloon due to the viscosity of the reinforcing mixture, the viscosity of the reinforcing mixture being 1000 cP or less,

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 fiber extending through a second lumen of the catheter and into the balloon to guide the light into the balloon to cure the reinforcing mixture when the fractured bone has been placed in the correct orientation; 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.

12. The apparatus of claim 11, 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.

13. The apparatus of claim 11, 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.

14. The apparatus of claim 11, further comprising a light source coupled to the at least one fiber and configured to deliver the light to the at least one fiber to cure the reinforcing mixture, and a switch coupled to the at least one fiber, the switch being configured to control the light guided by the fiber into the balloon to prevent inadvertent illumination of the bone reinforcing mixture.

15. 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 a first 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;

adjusting the substantially inflated state of the balloon to place the bone in a correct orientation by inflating or deflating the balloon by altering an amount of the bone reinforcing mixture in the balloon due to the viscosity of the bone reinforcing mixture, the viscosity of the bone reinforcing mixture being 1000 cP or less; and

; and

delivering a light from a light source to the balloon through a second lumen of the catheter to harden the reinforcing mixture in the balloon when the bone has been placed in the correct orientation.

16. The method of claim 15, further comprising controlling the light from the light source with a switch to prevent inadvertent illumination of the reinforcing mixture.

17. The method of claim 15, further comprising encapsulating the balloon in an expandable metallic tube.

18. The method of claim 17, wherein the expandable metallic tube is capable of being split to provide a greater longitudinal strength than that of a length of the balloon.

19. The method of claim 15, further comprising engaging the balloon with a radial structural member.

20. The method of claim 15, further comprising expanding a radial structure member while inflating the balloon as the bone reinforcing mixture enters the balloon under pressure.