Expandable spinal sheath and method of use

• US 7,951,110 B2
• Filed: 11/09/2009
• Issued: 05/31/2011
• Est. Priority Date: 11/10/2008
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Nguyen, Huan T., Bishop, Joseph, Nance, Edward J., Lenker, Jay
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/614,715
• Publication Number:
  US 20100145267A1
• Time in Patent Office: 568 Days
• Field of Search: 604/96.01, 604/103.05, 604/163, 60416401-16413, 606/191, 606/279, 623/1.11, 623/13.15, 600/207
• US Class Current: 604/96.01
• 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 method of introducing instruments or implants into a target region proximate the human spinal column, the method comprising the steps of:

creating a skin incision at a lateral position on a patient near a level of a spinal region to be treated;

inserting a guidewire into the skin incision and routing the guidewire to a target region of the spine through a muscle, the muscle comprising one of a Psoras muscle and lumbar muscle;

inserting a collapsed sheath, with a dilator pre-inserted and an outer pressure jacket, over the guidewire such that the distal end of the collapsed sheath is proximate the target region of the spine;

radially expanding an expandable region of the sheath with the dilator, to create an expanded sheath, so that the expandable region radially dilates the muscle and forms a channel through the muscle;

removing the dilator from a remaining lumen of the expanded sheath;

performing therapy or diagnosis at the target region through the lumen of the expanded sheath;

pressurizing a space between the outer pressure jacket and expandable region to collapse the expandable region;

evacuating the space between the outer pressure jacket and collapsed expandable region to draw the outer pressure jacket inward; and

removing the sheath from the patient.

2. The method of claim 1, further comprising the step of affixing a hub to a stabilizer positioned outside the patient, wherein the hub is affixed to the proximal end of the sheath.

3. The method of claim 1, further comprising inserting therapeutic or diagnostic instruments through the expanded sheath.

4. The method of claim 1, further comprising inserting or removing spinal implants through the expanded sheath.

5. The method of claim 1, wherein the therapy comprises removing spinal material through the expandable sheath.

6. The method of claim 1, wherein the step of expanding the dilator causes radial dilation of the muscle and adjacent tissue.

7. The method of claim 1, wherein the therapy comprises placement of a vertebral body spacer between the vertebrae.

8. The method of claim 1, wherein the therapy comprises placement of an annular repair device between the vertebrae.

9. The method of claim 1, wherein the expansion of the distal region comprises a first expansion step from the first, unexpanded configuration to a second, intermediate configuration followed by a second expansion step from the second, intermediate configuration to the final fully expanded configuration.

10. The method of claim 1, wherein the dilation of the distal region step comprises advancing a hollow, axially elongate dilator distally through the collapsed distal expandable region.

11. A method of introducing instruments or implants into a target region proximate the human spinal column, the method comprising the steps of:

creating a skin incision on a patient near a level of a spinal region to be treated;

inserting a guidewire into the skin incision and routing the guidewire to a target region of the spine through a muscle, the muscle comprising one of a Psoras muscle and lumbar muscle;

inserting a sheath, comprising an expandable region in a collapsed configuration with a pre-inserted dilator, over the guidewire such that the distal end of the sheath is proximate the target region of the spine, the expandable region comprising a malleable reinforcement embedded between outer and inner polymeric layers and, in the collapsed configuration, a double fold, the double fold comprising two longitudinal outside edges and two longitudinal inside edges;

radially expanding the expandable region of the sheath with the dilator to an expanded configuration, so that the expandable region radially dilates the muscle and forms a channel through the muscle;

removing the dilator from a remaining lumen of the expandable region;

performing therapy or diagnosis at the target region through the lumen of expandable region; and

removing the sheath from the patient;

wherein the malleable reinforcement is configured to maintain the expandable region in the collapsed configuration and, when the expandable region is expanded, reform to provide hoop strength to the expandable region in the expanded configuration.

12. The method of claim 11, further comprising the step of affixing a hub to a stabilizer positioned outside the patient, wherein the hub is affixed to the proximal end of the sheath.

13. The method of claim 11, further comprising inserting therapeutic or diagnostic instruments through the expandable region.

14. The method of claim 11, further comprising inserting or removing spinal implants through the expandable region.

15. The method of claim 11, wherein the therapy comprises removing spinal material through the expandable region.

16. The method of claim 11, wherein the step of expanding the expandable region causes radial dilation of the muscle and adjacent tissue.

17. The method of claim 11, wherein the therapy comprises placement of a vertebral body spacer between the vertebrae.

18. The method of claim 11, wherein the therapy comprises placement of an annular repair device between the vertebrae.

19. The method of claim 11, wherein expansion of the expandable region comprise a first expansion step from the collapsed configuration to an intermediate configuration followed by a second expansion step from the intermediate configuration to the expanded configuration.

20. The method of claim 11, wherein the dilation of the expandable region step comprises advancing a hollow, axially elongate dilator distally through the expandable region.

21. The method of claim 20, further comprising the step of re-collapsing the expandable region of the sheath to a smaller diameter prior to removing the sheath from the patient.