EXPANDABLE SPINAL SHEATH AND METHOD OF USE
First Claim
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 Assignments
0 Petitions
Accused Products
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.
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Citations
46 Claims
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1. A percutaneous access sheath assembly comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of introducing instruments or implants into a target region proximate the human spinal column, the method comprising the steps of:
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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 Psoras muscle; inserting a collapsed sheath with a dilator pre-inserted, 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 Psoras muscle and forms a channel through the Psoras muscle; removing the dilator from a remaining lumen of the expanded sheath; performing therapy or diagnosis at the target region through the lumen of expanded sheath; and removing the sheath from the patient. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A method of introducing instruments or implants into a target region proximate the human spinal column, the method comprising the steps of:
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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 lumbar muscle; inserting a collapsed sheath with a dilator pre-inserted, 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 lumbar muscle and forms a channel through the lumbar muscle; removing the dilator from a remaining lumen of the expanded sheath; performing therapy or diagnosis at the target region through the lumen of expanded sheath; and removing the sheath from the patient. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. 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 reaching 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 and can be expanded into a second cross-sectional configuration in which the at least one diametrically expanded region is unfolded larger cross-sectional profile. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
- the sheath comprising;
Specification