Insertion devices and method of use

• US 20050090852A1
• Filed: 05/18/2004
• Published: 04/28/2005
• Est. Priority Date: 04/07/2000
• Status: Active Grant

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Layne, Richard W., Scribner, Robert M., Ralph, Christopher R., Hsia, Alex, Seto, Christine L., Ico, Cesar A.
• Granted Patent: US 7,815,649 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

This invention relates to devices for inserting expandable structures, such as medical balloons, into interior regions of a human or animal body, as well as methods for their use. The insertion devices described herein are capable of directionally guiding and/or inhibiting expansion of an expandable structure within an interior region of an animal or human body to create optimally placed cavities for repair, augmentation and/or treatment of fractured and/or diseased bone.

Claims

1. A bone treatment device comprising

an expandable structure, and

a sheath housing the expandable structure, the sheath including an opening extending along and about the axis of the sheath to direct expansion of the expandable structure, the sheath including at least one securing element that secures the expandable structure within the sheath.

2. A device as in claim 1

wherein the securing element is a tab.

3. A device as in claim 2

wherein the tab is tapered.

4. A device as in claim 1

wherein the opening extends along the axis of the sheath and about the axis of the sheath for less than 360°

.

5. A device as in claim 1

wherein the expandable structure is adapted to compact cancellous bone.

6. A device as in claim 1, further comprising

a stylet having a distal end and sized and configured to extend through the expandable structure, the distal end of the stylet extending at least in part beyond the distal end of the sheath.

7. A device as in claim 6

wherein the distal end of the stylet is blunt.

8. A cortical bone wall probe comprising

a sheath extending along an axis and having a distal end,

a shaft having a distal end and being sized and configured for passage through the sheath, and

a stylet having a blunt distal end and sized and sized and configured for passage through the shaft, the blunt distal end extending at least in part beyond the distal end of the sheath and the distal end of the shaft.

9. A cortical bone wall probe as in claim 8, further comprising

an expandable structure carried by the shaft, and

wherein the sheath includes an opening extending along the axis of the sheath and about the axis of the sheath to direct expansion of the expandable structure.

10. A cortical bone wall probe as in claim 9

wherein the expandable structure is adapted to be expanded outside of the opening and beyond the sheath.

11. A cortical bone wall probe as in claim 9

wherein the opening extends along the axis of the sheath and about the axis of the sheath for less than 360°

to direct expansion of the expandable structure.

12. A cortical bone wall probe as in claim 9

wherein the expandable structure is adapted to compact cancellous bone.

13. A cortical bone wall probe as in claim 9

wherein the sheath includes at least one securing element that prevents movement of the shaft within the sheath.

14. A cortical bone wall probe as in claim 13

wherein the securing element is a tab.

15. A bone treatment device comprising

an expandable structure carried by a shaft, the shaft having a lumen extending therethrough and a distal end,

a stylet having a blunt distal tip and sized and configured for passage through the lumen to extend the blunt distal tip, at least in part, beyond the distal end of the shaft to form a balloon catheter assembly, and

a sheath having a distal end and sized and configured for passage of the catheter assembly, the sheath including an opening for receiving the expandable structure and at least one securing element for securing the sheath to the distal end of the shaft.

16. A device as in claim 15

wherein the distal tip of the stylet extends at least in part beyond the distal end of the sheath.

17. A method of treating bone comprising the steps of

introducing an insertion device through a cortical bone region and into a cancellous bone region of the bone,

introducing a balloon catheter assembly through the insertion device, the balloon catheter assembly comprising an expandable structure and a sheath housing the expandable structure, the sheath including an opening extending along and about the axis of the sheath to direct expansion of the expandable structure and at least one securing element that secures the expandable structure within the sheath, and

expanding the expandable structure outside the opening and beyond the sheath to create a cavity within the bone.

18. A method as in claim 17

wherein expansion of the expandable body compacts cancellous bone.

19. A method as in claim 17, further comprising

filling the cavity with a bone filler.