Expandable percutaneous sheath

• US 7,914,555 B2
• Filed: 01/13/2006
• Issued: 03/29/2011
• Est. Priority Date: 07/02/2002
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Shaolian, Samuel M., Nguyen, Thanh Van, Pham, To V., Teitelbaum, George P.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): Mendoza; Michael G
• Application Number:
  US11/331,140
• Publication Number:
  US 20060142795A1
• Time in Patent Office: 1,901 Days
• Field of Search: 606/191, 606/198, 606/60, 606/86, 606/192, 606/195, 606/246, 606247-279, 623/1.1, 623 111- 113, 623/1.15, 623/1.24, 623/1.25, 623/11.11, 623/17.11, 623/17.12
• US Class Current: 606/246
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a removable tubular restraint. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures.

Claims

1. A method of providing percutaneous access, said method comprising:

percutaneously inserting an elongated tubular structure having a first, smaller cross-sectional profile;

removing a tubular restraint from the elongate tubular structure; and

expanding said elongate tubular structure from said first, smaller cross-sectional profile to a second, greater cross-sectional profile,

wherein the percutaneously inserting step comprises percutaneously inserting the elongate tubular structure through an aperture in a bone anchor.

2. The method of claim 1, additionally comprising the step of inflating a balloon to expand said elongate tubular structure from said first, smaller cross-sectional profile to said second, greater cross-sectional profile.

3. The method of claim 2, wherein the inflating a balloon step is accomplished using a balloon catheter positioned within the tubular body.

4. The method of claim 2, further comprising the step of removing the balloon from the tubular structure following the expanding step.

5. The method of claim 1, further comprising the step of introducing an implant through the tubular structure when the tubular structure is in the second, greater cross sectional profile.

6. The method of claim 5, wherein the implant comprises a formed in place orthopedic implant.

7. A method of providing percutaneous access, said method comprising:

inserting an elongate tubular structure having a distal portion with a first, smaller cross-sectional profile into an insertion sheath such that the distal portion of the elongate tubular structure is positioned within a restraint section of the insertion sheath, the restraint section of the insertion sheath sized and shaped to retain the distal portion of the elongate tubular structure in the first, smaller cross-sectional profile;

removing the restraint section of the insertion sheath from around the distal portion of the elongate tubular structure; and

expanding said elongate tubular structure from said first, smaller cross-sectional profile to a second, greater cross-sectional profile,

wherein the inserting step further comprises percutaneously inserting at least the distal portion of the elongate tubular structure through an aperture in an anchor which is attached to a vertebral body.

8. A method of providing percutaneous access, said method comprising:

percutaneously inserting an elongated tubular structure having a first, smaller cross-sectional profile;

removing a tubular restraint from the elongate tubular structure, the tubular restraint sized and shaped to retain the elongated tubular structure in the first, smaller cross-sectional profile; and

expanding said elongate tubular structure from said first, smaller cross-sectional profile to a second, greater cross-sectional profile,

wherein the percutaneously inserting step comprises percutaneously inserting the elongate tubular structure through at least a first bone anchor attached to a first vertebral body and a second bone anchor attached to a second vertebral body.

9. A method of providing percutaneous access, said method comprising:

percutaneously inserting an access sheath assembly, the access sheath assembly including an insertion sheath having a restraint section, and an access sheath within the insertion sheath, the access sheath having a first cross-sectional profile;

opening the insertion sheath along said restraint section; and

expanding the access sheath to a second cross-sectional profile,

wherein the step of percutaneously inserting an access sheath assembly comprises percutaneously inserting the access sheath assembly through a portal of at least one bone anchor.

10. The method of claim 9, wherein the access sheath assembly further comprises a deployment catheter.

11. The method of claim 9, wherein the step of opening the insertion sheath along said restraint section comprises:

tearing the insertion sheath along the restraint section.

12. The method of claim 9, wherein the step of expanding the access sheath to a second cross-sectional profile comprises:

inflating a balloon to expand the access sheath.

13. The method of claim 12, wherein the step of opening the insertion sheath along said restraint section comprises:

partially inflating said balloon.

14. The method of claim 12, further comprising the step of:

deflating the balloon.

15. The method of claim 9, wherein the step of percutaneously inserting an access sheath assembly comprises percutaneously inserting the access sheath assembly along a guide wire.

16. The method of claim 9, further comprising the step of:

introducing an implant through the access sheath when the access sheath is expanded to the second cross-sectional profile.

17. The method of claim 9, wherein the implant comprises a formed in place orthopedic implant.

18. The method of claim 9, further comprising the step of:

introducing a surgical instrument through the access sheath when the access sheath is expanded to the second cross-sectional profile.