DELIVERY SYSTEM ASSEMBLIES AND ASSOCIATED METHODS FOR IMPLANTABLE MEDICAL DEVICES
First Claim
1. A delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:
- a handle including at least one control member;
an elongate outer tube extending distally from the handle and forming a lumen that extends from a proximal opening thereof at a proximal end of the outer tube to a distal opening thereof at a distal end of the outer tube, the proximal end of the outer tube being coupled to one of the at least one control member of the handle, the outer tube being longitudinally moveable relative to the handle, via the control member, and the outer tube including a distal-most portion having a length along which the lumen is sized to contain an entirety of the medical device therein, the distal opening of the lumen allowing passage of the medical device therethrough for the deployment;
an elongate inner member extending within the lumen of the outer tube, the inner member including a proximal end and a distal end, the distal end being configured to conform to a proximal end of the implantable medical device and to engage within the distal-most portion of the outer tube at a location that allows the engaged distal end of the inner member and the entirety of the medical device to be contained within the distal-most portion together; and
an articulation sheath surrounding the outer tube in between the handle and the distal-most portion of the outer tube such that the outer tube is longitudinally moveable within the sheath, the sheath including a proximal end, located distal to the handle, a distal end, and a pull-wire member extending between the proximal and distal ends of the sheath, the pull-wire member including a proximal control end and a distal end, the distal end being anchored in proximity to the distal end of the sheath for deflection thereof, and the sheath having an inner diameter that is smaller than an outer diameter of the distal-most portion of the outer tube and an outer diameter of the handle;
wherein, when the distal end of the inner member is engaged within the distal-most portion of the outer tube, longitudinal movement of the outer tube, in a distal direction, relative to the articulation sheath, causes similar longitudinal movement of the inner member; and
when the outer tube is moved longitudinally in a proximal direction, relative to the handle, the distal end of the inner member is disengaged within the distal-most portion of the outer tube so that the movement of the outer tube is independent of the inner member.
1 Assignment
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Accused Products
Abstract
A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.
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Citations
25 Claims
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1. A delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:
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a handle including at least one control member; an elongate outer tube extending distally from the handle and forming a lumen that extends from a proximal opening thereof at a proximal end of the outer tube to a distal opening thereof at a distal end of the outer tube, the proximal end of the outer tube being coupled to one of the at least one control member of the handle, the outer tube being longitudinally moveable relative to the handle, via the control member, and the outer tube including a distal-most portion having a length along which the lumen is sized to contain an entirety of the medical device therein, the distal opening of the lumen allowing passage of the medical device therethrough for the deployment; an elongate inner member extending within the lumen of the outer tube, the inner member including a proximal end and a distal end, the distal end being configured to conform to a proximal end of the implantable medical device and to engage within the distal-most portion of the outer tube at a location that allows the engaged distal end of the inner member and the entirety of the medical device to be contained within the distal-most portion together; and an articulation sheath surrounding the outer tube in between the handle and the distal-most portion of the outer tube such that the outer tube is longitudinally moveable within the sheath, the sheath including a proximal end, located distal to the handle, a distal end, and a pull-wire member extending between the proximal and distal ends of the sheath, the pull-wire member including a proximal control end and a distal end, the distal end being anchored in proximity to the distal end of the sheath for deflection thereof, and the sheath having an inner diameter that is smaller than an outer diameter of the distal-most portion of the outer tube and an outer diameter of the handle; wherein, when the distal end of the inner member is engaged within the distal-most portion of the outer tube, longitudinal movement of the outer tube, in a distal direction, relative to the articulation sheath, causes similar longitudinal movement of the inner member; and when the outer tube is moved longitudinally in a proximal direction, relative to the handle, the distal end of the inner member is disengaged within the distal-most portion of the outer tube so that the movement of the outer tube is independent of the inner member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A delivery system assembly facilitating deployment of an implantable medical device, the assembly comprising:
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a handle including at least one control member; an elongate outer tube extending distally from the handle and forming a lumen that extends from a proximal opening thereof at a proximal end of the outer tube to a distal opening thereof at a distal end of the outer tube, the proximal end of the outer tube being coupled to one of the at least one control member of the handle, the outer tube being longitudinally moveable relative to the handle, via the control member, and the outer tube including a distal-most portion having a length along which the lumen is sized to contain an entirety of the medical device therein, the distal opening of the lumen allowing passage of the medical device therethrough for the deployment; an elongate inner member extending within the lumen of the outer tube and forming an inner lumen that extends from a proximal opening thereof at a proximal end of the inner member to a distal opening thereof at a distal end of the inner member, the distal end of the inner member being configured to conform to a proximal end of the implantable medical device and to engage within the distal-most portion of the outer tube at a location that allows the engaged distal end of the inner member and the entirety of the medical device to be contained within the distal-most portion together; an articulation sheath surrounding the outer tube in between the handle and the distal-most portion of the outer tube such that the outer tube is longitudinally moveable within the sheath, the sheath including a proximal end, located distal to the handle, and a distal segment having a pre-formed curvature, and the sheath having an inner diameter that is smaller than an outer diameter of the distal-most portion of the outer tube and an outer diameter of the handle; and a straightening mandrel configured to slide within the inner lumen of the inner member and having a length sufficient to straighten the pre-formed curvature of the distal segment of the articulation sheath when the mandrel is fully inserted within the inner lumen of the inner member; wherein, when the distal end of the inner member is engaged within the distal-most portion of the outer tube, the longitudinal movement of the outer tube, in a distal direction, relative to the articulation sheath, causes similar longitudinal movement of the inner member; and when the outer tube is moved longitudinally in a proximal direction, relative to the handle, the distal end of the inner member is disengaged within the distal-most portion of the outer tube so that the movement of the outer tube is independent of the inner member. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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18. A method for navigating a delivery system assembly through a venous system of a patient for deployment of an implantable medical device, the method comprising:
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loading an entirety of the implantable medical device into a distal-most portion of an outer tube of a delivery system assembly such that a proximal end of the medical device abuts a distal end of an inner member of the delivery system assembly, the inner member extending within a lumen formed by the outer tube; advancing the delivery system assembly within a venous system of a patient to locate the distal-most portion of the outer tube, with the medical device loaded therein, within a right atrium of the patient; orienting the located distal-most portion of the outer tube toward a tricuspid valve of the patient by deflecting a distal end of a sheath of the delivery system assembly, the sheath extending around the outer tube such that the distal end of the sheath is positioned proximal to the distal-most portion of the outer tube; and advancing, with respect to the deflected distal end of the sheath, the distal-most portion of the outer tube through the tricuspid valve and into a right ventricle of the patient to a target implant site, such that the distal-most portion of the outer tube abuts the target implant site, the advancing carrying the distal end of the inner member and the loaded medical device along with the distal-most portion, by means of an engagement of the distal end of the inner member within the lumen of the outer tube. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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Specification