EXPANDABLE DEVICE AND METHODS OF USE

• US 20140214085A1
• Filed: 01/25/2013
• Published: 07/31/2014
• Est. Priority Date: 01/25/2013
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: DRUMA, CALIN
• Granted Patent: US 9,351,779 B2
• Time in Patent Office: Days
• US Class Current: 606/279
• CPC Class Codes: A61B 17/8802 Equipment for handling bone cement or other fluid fillers
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855

Abstract

A surgical system including an expandable device is provided, including an inflatable body, an inner shaft and an outer shaft. The inflatable body has at least one folded segment, which are housed in a distal portion of the outer shaft. The inflatable body is tethered to a portion of the outer shaft. The inner shaft is affixed to a portion of the inflatable body, and is configured to control an axial and/or a radial inflation pattern of the folded inflatable body.

Claims

1. An expandable device including:

an inflatable body defining a longitudinal axis;

an inner shaft; and

an outer shaft, the inflatable body having a folded segment comprising a bellows configured to expand and contract a length of said folded segment along said longitudinal axis, said folded segment housed in a distal portion of the outer shaft, the inflatable body tethered to a portion of an inner wall of the outer shaft, and the inner shaft affixed to a portion of the inflatable body, the inner shaft configured to control an axial and/or a radial inflation pattern of the folded inflatable body.

2. An expandable device according to claim 1, wherein the inflatable body has a collapsed configuration and an expanded configuration, wherein in the expanded configuration, the inflatable body is configured to self-extend outside of an open end of a distal tip of the outer shaft.

3. An expandable device according to claim 1, wherein the inflatable body has a plurality of bellows.

4. An expandable device according to claim 1, wherein the outer shaft has a tubular portion and a housing portion.

5. An expandable device according to claim 4, wherein the inflatable body is positioned in the housing portion.

6. An expandable device according to claim 4, wherein a diameter of the housing portion is larger than a diameter of the tubular portion of the outer shaft.

7. An expandable device according to claim 1, wherein a proximal end of the inflatable body is tethered to an inner surface of the housing portion of the outer shaft, and further wherein a distal end of the inner shaft is affixed to a distal end of the inflatable body.

8. An expandable device system including a cannula comprising:

an expandable device having an outer shaft having a housing portion and a tubular portion;

an inner shaft having a proximal portion and a distal portion; and

a balloon extending along a longitudinal axis between proximal distal ends thereof, the balloon positioned in the housing portion of the outer shaft, the proximal end of the balloon bonded to an inner surface of the housing portion of the outer shaft, said balloon having a distal end bonded to a distal portion of the inner shaft, the balloon having a folded segment comprising a bellows, the housing portion having a larger diameter than the tubular portion of the outer shaft.

9. An expandable device system according to claim 8, wherein the bellows is configured to expand a length of said folded segment along said longitudinal axis.

10. An expandable device system according to claim 8, wherein the bellows is configured to expand and contract a length of said folded segment along said longitudinal axis.

11. An expandable device system according to claim 8, further comprising a filling apparatus comprising a pressurized fluid.

12. An expandable device system according to claim 8, wherein the proximal portion of inner shaft is configured to have slack.

13. An expandable device system according to claim 8, wherein the bellows is configured to self-extend in an axial dilation upon an introduction of the pressurized fluid into the balloon, wherein the distal end of the inner shaft is configured to control the length of the axial dilation of the balloon.

14. A method for treating a bone fracture or bone lesion using an expandable device is provided, the method comprising:

accessing a bone;

inserting into the bone an expandable device having an outer shaft having a tubular portion and a housing portion, an inner shaft extending along a longitudinal axis between a distal end and a proximal end, and a deflated balloon positioned in the housing portion of the outer shaft, said balloon having a proximal portion bonded to an inner surface of the housing portion of the outer shaft, said balloon having a distal portion bonded to the distal portion of the inner shaft, the balloon having an axially folded segment comprising a bellows configured to expand and contract a length of said folded segment along said longitudinal axis;

inflating said balloon with a pressurized fluid wherein the balloon is configured to self-extend in an axial dilation;

locking the inner shaft in a position within the expandable device wherein said locked inner shaft is configured to stop the balloon from further axial dilation;

inflating said balloon with an additional amount of the pressurized fluid, said locked inner shaft configured to cause the balloon to extend in a radial dilation;

creating a void in the bone with said the inflated balloon;

deflating said balloon and removing said expandable device from the bone;

inserting a bone void filler into the void; and

allowing said inserted bone void filler to harden.

15. A method as recited in claim 14, wherein the balloon is configured to clear debris resulting from a fracture from a cortical bone by pushing the debris to a cortical bone wall.

16. A method as recited in claim 14, wherein the bone is a vertebral body.

17. A method as recited in claim 14, wherein a diameter of the housing portion is larger than a diameter of the tubular portion of the outer shaft.

18. A method as recited in claim 14, wherein the balloon has a plurality of bellows.

19. A method as recited in claim 14, wherein the inner shaft is configured to control a pattern of self-extension of the balloon.

20. A method as recited in claim 14, wherein the balloon is compliant.