Percutaneous flat lead introducer
First Claim
1. A stimulation lead introducer for facilitating implantation of a lead, the stimulation lead introducer comprising:
- an elongated dilator defining a dilator lumen sized to advance over a guidewire, the elongated dilator being configured to widen a path through an epidural region proximate a spine of a patient by following the guidewire through the epidural region proximate the spine of the patient, the elongated dilator being sized such that the widened path facilitates advancement of the lead through the epidural region proximate the spine of the patient, wherein the dilator includes a substantially deformable distal tip with a substantially oblong cross-section; and
an elongated sheath defining a sheath lumen, at least a portion of the sheath lumen being sized to accommodate the dilator, wherein the sheath is configured to facilitate advancement of the lead along a portion of the path when the dilator is not present in the sheath, wherein the sheath includes a sheath material that is substantially deformable, andwherein the dilator is configured to extend beyond a distal end of the sheath lumen.
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Accused Products
Abstract
In general, the invention is directed to a technique for percutaneously introducing a stimulation lead into a target stimulation site via the epidural region proximate the spine of a patient. The process of introducing the stimulation lead may include the use of a hollow stimulation lead introducer, which comprises an elongated sheath and an elongated dilator. The dilator fits within the sheath and serves to widen a path through the epidural region for the introduction of a stimulation lead. At least a portion of the stimulation lead introducer has an oblong cross-section, allowing passage of stimulation leads such as paddle leads. The stimulation lead introducer may enter the epidural region proximate a spine of a patient via a guidewire. The stimulation lead introducer provides a path through the epidural region of a patient to a target stimulation site. A stimulation lead may travel through the path to reach the target stimulation site where it may provide therapy to the patient.
207 Citations
20 Claims
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1. A stimulation lead introducer for facilitating implantation of a lead, the stimulation lead introducer comprising:
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an elongated dilator defining a dilator lumen sized to advance over a guidewire, the elongated dilator being configured to widen a path through an epidural region proximate a spine of a patient by following the guidewire through the epidural region proximate the spine of the patient, the elongated dilator being sized such that the widened path facilitates advancement of the lead through the epidural region proximate the spine of the patient, wherein the dilator includes a substantially deformable distal tip with a substantially oblong cross-section; and an elongated sheath defining a sheath lumen, at least a portion of the sheath lumen being sized to accommodate the dilator, wherein the sheath is configured to facilitate advancement of the lead along a portion of the path when the dilator is not present in the sheath, wherein the sheath includes a sheath material that is substantially deformable, and wherein the dilator is configured to extend beyond a distal end of the sheath lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for introducing a stimulation lead comprising:
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inserting a needle into an epidural region proximate a spine of a patient; inserting a guidewire into the needle such that a distal end of the guidewire extends within the epidural region proximate the spine of the patient; withdrawing the needle over the guidewire from the epidural region of the patient; inserting a stimulation lead introducer to a target site within the epidural region proximate the spine of the patient via the guidewire following withdrawal of the needle, the stimulation lead introducer widening a path created by the needle to have a substantially oblong cross-section, wherein the introducer includes; an elongated dilator defining a dilator lumen sized to advance over a guidewire, the elongated dilator being configured to widen a path through an epidural region proximate a spine of a patient by following the guidewire through the epidural region proximate the spine of the patient, the elongated dilator being sized such that the widened path facilitates advancement of the lead through the epidural region proximate the spine of the patient, wherein the dilator includes a substantially deformable distal tip with a substantially oblong cross-section; and an elongated sheath defining a sheath lumen, at least a portion of the sheath lumen being sized to accommodate the dilator, wherein the sheath is configured to facilitate advancement of the lead along a portion of the path when the dilator is not present in the sheath, wherein the sheath includes a sheath material that is substantially deformable, and wherein the dilator is configured to extend beyond a distal end of the sheath lumen; withdrawing the guidewire from the epidural region proximate the spine of the patient; withdrawing the dilator from the sheath; and introducing the stimulation lead within the epidural region proximate the spine of the patient via the sheath following withdrawal of the dilator and the guidewire. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A kit for implanting a lead proximate a spine of a patient via a path through the epidural region proximate the spine, the kit comprising:
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a needle configured for insertion into the epidural region proximate the spine of the patient; a guidewire sized to pass through a lumen of the needle and into the epidural region proximate the spine of the patient; and a stimulation lead introducer, wherein the stimulation lead introducer includes; an elongated dilator defining a dilator lumen sized to advance over the guidewire, the elongated dilator being configured to widen a path through the epidural region proximate a spine of a patient by following the guidewire through the epidural region proximate the spine of the patient, the elongated dilator being sized such that the widened path facilitates advancement of the lead through the epidural region proximate the spine of the patient, wherein the dilator includes a substantially deformable distal tip with a substantially oblong cross-section; and an elongated sheath defining a sheath lumen, at least a portion of the sheath lumen being sized to accommodate the dilator, wherein the sheath is configured to facilitate advancement of the lead along a portion of the path when the dilator is not present in the sheath, wherein the sheath includes a sheath material that is substantially deformable, and wherein the dilator is configured to extend beyond a distal end of the sheath lumen. - View Dependent Claims (18, 19, 20)
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Specification