Expandable device and methods of use

• US 9,351,779 B2
• Filed: 01/25/2013
• Issued: 05/31/2016
• Est. Priority Date: 01/25/2013
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Druma, Calin
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): ECKMAN, MICHELLE CHRISTINE
• Application Number:
  US13/750,621
• Publication Number:
  US 20140214085A1
• Time in Patent Office: 1,222 Days
• Field of Search: 606/99, 606/105, 606191-192, 623 1711- 1716
• US Class Current: 1/1
• 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 having a closed distal end; and

an outer shaft comprising a rigid material, 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 comprising a proximal end tethered to a portion of an inner wall of the outer shaft and a distal end affixed to the closed distal end of the inner shaft, the inner shaft being free-floating within the outer shaft such that said inner shaft is free of any connection to said outer shaft and 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 2, wherein the inner shaft has a maximum length defined by a distance between a proximal end surface of the inner shaft and an opposite distal end surface of the inner shaft, the maximum length being coaxial with the longitudinal axis when the inflatable body is in both the collapsed and expanded configurations.

4. An expandable device according to claim 2, wherein:

the outer shaft has a tubular portion and a housing portion that includes the distal tip;

the inflatable body is positioned entirely within the housing portion when in the collapsed configuration such that the distal end of the inflatable body is positioned between the proximal end of the inflatable body and the open end.

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

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

7. An expandable device according to claim 6, wherein the inflatable body is positioned in the housing portion.

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

9. An expandable device according to claim 1, wherein the closed distal end of the inner shaft comprises a distal end surface that extends perpendicular to and intersects the longitudinal axis.

10. An expandable device according to claim 1, wherein the inner shaft has a maximum length defined by a distance between a proximal end surface of the inner shaft and an opposite distal end surface of the inner shaft, the maximum length being coaxial with the longitudinal axis.

11. An expandable device according to claim 1, wherein:

the outer shaft has a tubular portion and a housing portion; and

the outer shaft is tapered between the housing portion and the tubular portion, the housing portion and the tubular portion being coaxial with one another.

12. An expandable device according to claim 1, wherein the inner shaft extends between a proximal end surface and the closed distal end, the closed distal end having a distal end surface that extends parallel to the proximal end surface, the inner shaft having an intermediate portion midway between the proximal and distal end surfaces, the inner shaft having a uniform diameter from the proximal end surface to the intermediate portion.

13. An expandable device system comprising:

a cannula; and

an expandable device comprising;

an outer shaft having a housing portion and a tubular portion that are each positioned within the cannula;

an inner shaft having a proximal portion and a distal portion having a closed distal end, the inner shaft being free-floating within the outer shaft such that said inner shaft is free of any connection to said outer shaft; and

a balloon configured to create a void within a bone upon inflation of the balloon, the balloon extending along a longitudinal axis between proximal and 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 the closed distal end 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, the expandable device being tapered from the housing portion to the tubular portion.

14. An expandable device system according to claim 13, wherein the bellows is configured to expand a length of said folded segment along said longitudinal axis.

15. An expandable device system according to claim 13, wherein the bellows is configured to expand and contract a length of said folded segment along said longitudinal axis.

16. An expandable device system according to claim 13, 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.

17. 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 closed distal end and a proximal end, and a deflated balloon positioned in the housing portion of the outer shaft, said inner shaft being free-floating within the outer shaft such that said inner shaft is free of any connection to said 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 closed distal end 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 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.

18. A method as recited in claim 17, 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.

19. A method as recited in claim 17, wherein the inner shaft is configured to control a pattern of self-extension of the balloon.

20. A method as recited in claim 17, wherein the balloon is compliant.