Pain abatement catheter system
First Claim
1. A catheter system for diagnosis and treatment in an epidural space involving an epidural introducer assembly which comprises the following components:
- (a) a flexible outer sheath having distal and proximal ends wherein said proximal end terminates in a hub and a luer tapered end, said hub is connected to a flexible cannula rounded at its distal end and wherein a cylindrical bore defines the interior of said sheath;
(b) an introducer needle having proximal and distal ends and an interior bore and finger engageable wings attached at said proximal end, said wings having a distal and proximal face, said wings also having locking means on the distal face and a luer tapered hub attached on the proximal face of the wings, said introducer needle having a predetermined length and being adapted to be inserted and fixed by locking means into the interior bore of said flexible outer sheath and having at its distal end a cutting tip adapted for percutaneous introduction; and
(c) an inner stylet having a predetermined length and having proximal and distal ends and being adapted to be inserted within the interior bore of said introducer needle and wherein said proximal end is attached a lug having a luer fitting cap and at which distal end is a tip configured and dimensioned to fit between the contours of the cutting tip of the distal end of said introducer needle.
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Accused Products
Abstract
A pain abatement catheter system particularly suited for treatment within the epidural space of a patient which includes an epidural introducer assembly, an epidural catheter and a steerable epidural guidewire assembly. The introducer assembly provides a one-piece introduction into the epidural space and includes an elongated introducer needle, an inner stylet, and a flexible outer sheath with a hub. The improved epidural catheter may be safely introduced into the epidural space under fluoroscopic guidance and can be effectively steered through tortuous anatomy, adhesions, or scar tissue for the purpose of delivering medications or contrast dyes to highly selective areas of the epidural space including nerve-root-sleeve injections. The epidural catheter/hub assembly is advanced over a soft atraumatic tip guidewire which significantly decreases the risk of device breakage, nerve root damage, or spinal cord injury. The improved catheter also increases efficacy, maneuverability, and safety in the diagnosis and intervening treatment of acute and chronic back and limb pain. The steerable epidural guidewire assembly allows for safely introducing a guidewire into the epidural space through a flexible sheath cannula and effectively maneuvering the catheter into highly specific areas while reducing the risk of epidural, nerve root, or spinal cord injury.
69 Citations
20 Claims
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1. A catheter system for diagnosis and treatment in an epidural space involving an epidural introducer assembly which comprises the following components:
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(a) a flexible outer sheath having distal and proximal ends wherein said proximal end terminates in a hub and a luer tapered end, said hub is connected to a flexible cannula rounded at its distal end and wherein a cylindrical bore defines the interior of said sheath; (b) an introducer needle having proximal and distal ends and an interior bore and finger engageable wings attached at said proximal end, said wings having a distal and proximal face, said wings also having locking means on the distal face and a luer tapered hub attached on the proximal face of the wings, said introducer needle having a predetermined length and being adapted to be inserted and fixed by locking means into the interior bore of said flexible outer sheath and having at its distal end a cutting tip adapted for percutaneous introduction; and (c) an inner stylet having a predetermined length and having proximal and distal ends and being adapted to be inserted within the interior bore of said introducer needle and wherein said proximal end is attached a lug having a luer fitting cap and at which distal end is a tip configured and dimensioned to fit between the contours of the cutting tip of the distal end of said introducer needle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for introducing, guiding and removing medical devices in an epidural space using a catheter system comprising the steps of:
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(a) introducing percutaneously into the epidural space of a patient a one-piece introducer assembly comprising a flexible outer sheath and cannula connected to an introducer needle and an inner stylet; (b) removing the inner stylet to confirm placement in the epidural space; (c) unlocking and withdrawing the introducer needle away from the flexible outer sheath and cannula which remain placed in the epidural space of the patient; and (d) introducing or maneuvering through the flexible outer sheath a single or multiple piece catheter having or not having a soft tip. - View Dependent Claims (14, 15, 16)
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17. A method for precisely guiding an epidural catheter with or without a soft tip comprising the steps of:
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(a) providing an elongated reinforced or non-reinforced one-piece or multiple piece epidural catheter with the distal end having catheter side holes or an open end and a proximal end connected to a fitting for the administration of medication and media to facilitate patients comfort and procedure time reduction; (b) providing an epidural catheter of sufficient length to minimize radiation exposure to the practitioner; (c) inserting a flexible guidewire into the central lumen of the catheter; (d) reducing the catheter and/or guidewire shearing and/or scraping while advancing and/or withdrawing said components; and (e) connecting a manifold adapter to the epidural catheter hub whereby the guidewire remains in place during injection of medications and contrast media. - View Dependent Claims (18, 20)
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19. A method for precisely guiding an epidural catheter with or without a soft tip comprising the steps of:
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(a) providing an elongated reinforced or non-reinforced one-piece or multiple piece epidural catheter with a distal end having catheter side holes or an open end and a proximal end connected to a fitting for administration of medication and media to facilitate patients comfort and procedure time reduction; (b) providing an epidural catheter of sufficient length to minimize radiation exposure to a practitioner; (c) inserting a flexible guidewire into the central lumen of the catheter; (d) reducing the catheter and/or guidewire shearing and/or scraping while advancing and/or withdrawing said components; and (e) placing a torquing device on the guidewire to precisely guide the catheter into diseased areas of a spinal column and selective nerve roots.
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Specification