Expandable spinal sheath and method of use

• US 9,044,577 B2
• Filed: 05/13/2011
• Issued: 06/02/2015
• Est. Priority Date: 11/10/2008
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Lenker, Jay, Nance, Edward J., Nguyen, Huan T.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/107,184
• Publication Number:
  US 20120041466A1
• Time in Patent Office: 1,481 Days
• Field of Search: 604/96.01, 604/104, 604/164.1, 604/913, 606/191, 606/192
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1671 for the spine
• 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: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10S 606/90 Lumbar stabilizer

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 or by structural elements built into the wall of the expandable portion of the sheath. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures, preparation of a spinal segment, or placement of a vertebral body spacer. The sheath can further comprise structural elements to permit re-collapse of the sheath under fluid pressure following completion of the procedure and prior to removal from the patient.

Claims

1. A percutaneous access sheath assembly comprising:

an elongate tubular structure, a distal portion of said elongate tubular structure being expandable from a first cross-sectional profile to a second cross-sectional profile;

malleable reinforcing structures embedded within the wall of the distal portion, wherein the malleable reinforcing structures maintain the configuration of the distal portion in the state where it is forced by either manufacturing processes or expansion by a dilator;

a proximal portion of said elongate tubular structure being non-expandable;

a transition zone tapering from said larger non-expandable proximal portion to said smaller cross-section distal portion; and

a dilator comprising a balloon positionable inside said elongate tubular structure, wherein inflation of the balloon causes at least a portion of said distal portion to expand diametrically, wherein the balloon is removable from said elongate tubular structure after it has expanded the distal section and has been at least partially deflated;

wherein the first tapering point is present before said balloon is inflated but not after said balloon is inflated.

2. The apparatus of claim 1, wherein the balloon is carried by a balloon catheter pre-mounted within the elongate tubular structure.

3. The apparatus of claim 1, wherein the length of the expandable distal region ranges between 10 and 25 cm.

4. The apparatus of claim 1, wherein the diameter of the proximal region of the sheath ranges between 15 and 25 French.

5. The apparatus of claim 1, wherein the diameter of the expandable distal region of the sheath ranges between 15 and 25 French following expansion.

6. The apparatus of claim 1, wherein the dilator comprises a hollow axially elongate tubular structure that is advanced distally to expand the distal expandable region.

7. The apparatus of claim 1, further comprising a hub affixed to the proximal end of the sheath.

8. The apparatus of claim 1, further comprising a stabilizer having one end affixed to a reference point outside the patient and another end of the stabilizer affixed to a hub, wherein the hub is affixed to a proximal end of the sheath.

9. A port access apparatus for providing access to a patient'"'"'s spinal column through a puncture in the skin;

the sheath comprising;

a sheath having a distal portion, a proximal portion and a lumen extending therebetween, the proximal portion adapted to extend out of the patient and the distal portion adapted to extend through a puncture in the skin, through a muscular structure, and opening and providing access to a target region of the spine,

wherein the sheath comprises at least one diametrically expandable region that comprises a malleable reinforcement structure configured to maintain the at least one diametrically expandable region in a first cross-sectional configuration in which the at least one diametrically expandable region is longitudinally folded into a reduced cross-sectional profile having a first lumen diameter and can be expanded into a second cross-sectional configuration in which the at least one diametrically expanded region is unfolded to a larger cross-sectional profile having a second lumen diameter that is larger than said first lumen diameter.

10. The sheath of claim 9, wherein the expandable region expands from a first, smaller outside diameter of approximately 20 French or less to a second, larger outside diameter of approximately 36 French or larger.

11. The sheath of claim 9, wherein in the first cross-sectional configuration the at least one diametrically expandable region is longitudinally more flexible than in the second cross-sectional configuration.

12. The sheath of claim 9, further comprising a dilator pre-positioned within the sheath.

13. The sheath of claim 9, further comprising a hub affixed to its proximal portion.

14. The sheath of claim 9, further comprising a braided reinforcement member on the distal end of the sheath that is configured such that a proximal directed tension on the distal end of the sheath causes axial compression of the braided reinforcement in the sheath wall resulting in diametric expansion of the sheath.

15. The sheath of claim 9, wherein the expandable region comprises an elastic or semi-elastic wall.

16. The sheath of claim 9, wherein the expandable region comprises an elastic or semi-elastic wall further reinforced with an internal braid.

17. The sheath of claim 9, further comprising a hemostasis valve at the proximal end of the sheath to prevent excessive loss of blood from the patient.

18. The sheath of claim 9, further comprising a pre-inserted balloon dilator, wherein the balloon dilator comprises a non-distensible high-pressure balloon disposed along at least a portion of the length of the expandable region.

19. The sheath of claim 9, further comprising nitinol reinforcing elements within the expandable region.

20. The sheath of claim 19, wherein the nitinol reinforcing elements are biased to diametrically expand the expandable region.

21. The sheath of claim 19, wherein the nitinol reinforcing elements are biased to diametrically collapse the expandable region.

22. The sheath of claim 19, wherein the nitinol reinforcing elements comprise shape-memory properties that are fully activated at about body temperature.

23. The apparatus of claim 9, wherein the malleable reinforcement structure comprises a flat wire or ribbon wire wound into a coil.

24. The apparatus of claim 9, further comprising a pressure jacket and a pressure jacket pressurization port, wherein inflation of the pressure jacket pressurization port with fluid causes pressure to increase between the pressure jacket and the expandable region, causing the expandable region to collapse in a direction lateral to a longitudinal axis of the sheath.