VASCULAR PUNCTURE CLOSURE SYSTEM WITH GUIDE SHEATH STABILIZER
First Claim
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1. An apparatus for guiding a puncture closure device to a percutaneous puncture in a blood vessel wall comprising:
- an elongate sheath having proximal and distal ends and having a longitudinally extending central lumen receptive to a puncture closure device and a pair of longitudinally extending wire lumens, each of the lumens terminating in a separate distal port at the distal end of the sheath and the distal ports of the wire lumens being circumferentially spaced at opposing locations about a distal port of the central lumen, the ports each intersecting an imaginary plane extending centrally through the sheath;
each of the wire lumens containing a slidably movable retention wire, the distal end of each retention wire being sharp and adapted to pierce the wall of the vessel, the retention wires being slidable between a retracted position in which the distal ends are contained within their respective lumens and a deployed position in which the sharp ends are extended beyond the distal ports of their respective lumens;
a distal portion of each retention wire being preformed to a non-linear anchoring configuration when unconstrained, the anchoring configuration being adapted to resist detachment of the retention wire from the vessel wall when engaged with the vessel wall, the wire having sufficient flexibility to enable it to assume a linear configuration within its respective lumen when retracted into its lumen to its retracted position;
whereby the sheath may be located with its distal end adjacent and in registry with the puncture in the vessel and with the central plane of the sheath intersecting and extending longitudinally of the vessel, such that the retention wires can be advanced from their retracted positions to cause their sharp ends to engage and pierce the vessel wall at spaced locations proximally and distally of the puncture and to assume their anchoring configuration when engaged with the vessel wall to stabilize the sheath and central lumen in that position.
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Abstract
A guide sheath for use in guiding a vascular puncture closure device to and in registry with a vascular puncture includes a stabilization system having retention wires deployable from the sheath and engageable with the vessel wall. The retention wires pierce the vessel wall at spaced locations, proximally and distally, about the puncture and form anchors to retain the sheath in registry with the puncture.
20 Citations
17 Claims
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1. An apparatus for guiding a puncture closure device to a percutaneous puncture in a blood vessel wall comprising:
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an elongate sheath having proximal and distal ends and having a longitudinally extending central lumen receptive to a puncture closure device and a pair of longitudinally extending wire lumens, each of the lumens terminating in a separate distal port at the distal end of the sheath and the distal ports of the wire lumens being circumferentially spaced at opposing locations about a distal port of the central lumen, the ports each intersecting an imaginary plane extending centrally through the sheath; each of the wire lumens containing a slidably movable retention wire, the distal end of each retention wire being sharp and adapted to pierce the wall of the vessel, the retention wires being slidable between a retracted position in which the distal ends are contained within their respective lumens and a deployed position in which the sharp ends are extended beyond the distal ports of their respective lumens; a distal portion of each retention wire being preformed to a non-linear anchoring configuration when unconstrained, the anchoring configuration being adapted to resist detachment of the retention wire from the vessel wall when engaged with the vessel wall, the wire having sufficient flexibility to enable it to assume a linear configuration within its respective lumen when retracted into its lumen to its retracted position; whereby the sheath may be located with its distal end adjacent and in registry with the puncture in the vessel and with the central plane of the sheath intersecting and extending longitudinally of the vessel, such that the retention wires can be advanced from their retracted positions to cause their sharp ends to engage and pierce the vessel wall at spaced locations proximally and distally of the puncture and to assume their anchoring configuration when engaged with the vessel wall to stabilize the sheath and central lumen in that position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for stabilizing a sheath for guiding a closure device to a percutaneous puncture in a blood vessel wall comprising:
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providing a sheath having proximal and distal ends with a central lumen having a distal opening and adapted to receive a puncture closure device through the central lumen, the sheath having a pair of retention wires movable with respect to the sheath, each of the retention wires having a sharp distal end adapted to pierce the vessel wall and an anchor portion adjacent the distal end, the anchor portion being preformed with a non-linear configuration but having sufficient flexibility to enable the anchor portion to be constrained in a linear configuration when disposed within the sheath; locating the distal end of the sheath to orient the distal opening of the central lumen in registry with the puncture of the vessel; extending the retention wires to engage and pierce the vessel wall at spaced locations proximally and distally, with respect to the vessel puncture, the anchor portions assuming their non-linear configuration after the distal tips of the wires have pierced the vessel wall; whereby the engagement of the anchor portions with the vessel wall stabilizes the position of the sheath with respect to the vessel puncture to enable the closure device to be guided by the sheath to the region of the vessel puncture. - View Dependent Claims (16)
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17. A method as defined in claim 18 further comprising:
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substantially simultaneously with the operation of the puncture closure device, retracting the retention wires into their linear configurations within the sheath; and removing the sheath and the closure device from the patient.
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Specification