Edwards Lifesciences Cardiaq LLC

St. Jude Medical, Cardiology Division, Inc.

Syntheon Cardiology, LLC

Other

Syntheon Tavr, LLC

John P Cartledge

Richard Cartledge

Ralph Edward Gaskins, Jr

James Luis Badia

Luis Baez

Peter J Bentley

James A McCrea

Richard G Cartledge

Ralph E Gaskins

An assembly includes an implant body and a delivery apparatus. The implant body includes a lattice structure, an adjustment member, and a control device. The lattice structure is circumferentially expandable and contractible. The adjustment member and the control device are coupled to the lattice structure. Actuating the adjustment member results in circumferential expansion or contraction of the lattice structure. The delivery apparatus includes a rotatable adjustment tool and a locking mechanism comprising a controllable catch coupled to an end portion of the rotatable adjustment tool. The rotatable adjustment tool is configured to actuate the adjustment member of the implant body upon rotation of the rotatable adjustment tool. The controllable catch of the locking mechanism is configured to selectively couple the rotatable adjustment tool to the adjustment member of the implant body.

Surgical implant devices and methods for their manufacture and use

A method of implanting a prosthetic implant includes advancing a prosthetic implant into a patient's vasculature with a delivery apparatus, the delivery apparatus comprising a catheter and a control lead, the catheter including a lumen extending therethrough, the control lead extending through the lumen of the catheter, the prosthetic implant comprising an implant body, a seal extending radially outwardly from the implant body, and a locking bar coupled to the implant body and releasably coupled to the control lead, the locking bar radially offset relative to the central longitudinal axis of the implant body. The method further includes rotating the control lead of the delivery apparatus in a first direction relative to the catheter such that the locking bar rotates in the first direction relative to the implant body and the implant body expands radially from a first radially compressed state to a first radially expanded state.

Sealable endovascular implants and methods for their use

A vascular system includes a delivery apparatus and an endovascular device. The delivery apparatus including a catheter and a control lead. The control lead extends through a lumen of the catheter and is configured to be manipulated by a user. The endovascular device is releasably coupled to the delivery apparatus and includes an implant body, a seal extending radially outwardly from the implant body, and one or more tissue engaging elements. The seal is configured to contact native vascular tissue to reduce leakage between the native vascular tissue and the implant body. The tissue engaging elements are pivotable relative to the seal from a compressed state to an expanded state. In the compressed state, the tissue engaging elements are positioned so as to disengage the native vascular tissue. In the expanded state, the tissue engaging elements extend outwardly from the seal and are configured to engage the native vascular tissue.

A method of implanting a device in a heart includes inserting an implant into a blood vessel with a delivery apparatus. The implant includes a stent member and an adjustment member. The stent member is circumferentially expandable and contractible. The adjustment member is coupled to the stent member. The delivery apparatus includes a rotatable shaft and a locking mechanism coupled to an end portion of the shaft. The shaft of the delivery apparatus is releasably coupled to the adjustment member of the implant by the locking mechanism of the delivery apparatus. The method further includes positioning the implant at an implantation location within a heart by manipulating the delivery apparatus, and rotating the shaft of the delivery apparatus relative to the stent member of the implant to actuate the adjustment member of the implant. Actuating the adjustment member results in circumferential expansion or contraction of the stent member.

A prosthetic implant includes a circumferentially adjustable sealing collar and a rotatable sealer gear. The sealing collar has a central longitudinal axis. The rotatable sealer gear is coupled to and disposed within the sealing collar and configured to adjust the circumference of the sealing collar. The sealer gear is radially offset relative to the central longitudinal axis of the sealing collar. Rotating the sealer gear in a first direction relative to the sealing collar circumferentially expands the sealing collar. Rotating the sealer gear in a second direction relative to the sealing collar circumferentially contracts the sealing collar.

An implantable vascular device comprises an expandable and compressible implant body, a housing, a rotatable member, and a locking member. The housing is coupled to a first end portion of the implant body. The rotatable member is coupled to the housing and to a second end portion of the implant body such that rotating the rotatable member relative to the housing and the implant body expands or contracts the implant body. The locking member is coupled to the rotatable member and configured to move between an unlocked state and a locked state. In the unlocked state, the locking member allows the rotatable member to be rotated relative to the housing and the implant body. In the locked state, the locking member prevents the rotatable member from being rotated relative to the housing and the implant body.

Sealable and repositionable implant devices are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

This disclosure is directed toward sealable and repositionable implant devices that are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant.

A sealable vascular endograft system for placement in a vascular defect includes a delivery catheter shaped to be disposed within a blood vessel. The delivery catheter includes an implant delivery catheter sheath defining an implant delivery catheter lumen and an endovascular implant removably disposed within the implant delivery catheter lumen in a compressed or folded state for delivery thereof to the vascular defect. The endovascular implant includes a tubular implant body and a sealable circumferential collar including a variable sealing device and a control lead traversing from the variable sealing device to a user and controlling variability of the variable sealing device by the user. The sealing device and the control lead cooperate to reversibly expand and contract the sealable circumferential collar to circumferentially adjust during deployment thereof to achieve a repositionable fluid-tight seal between the sealable circumferential collar and the internal walls proximal to the vascular defect.

A delivery device for an annular implant is provided, comprising an annular implant having an adjustable dimension; a plurality of movable elongated deployment members, each having a proximal end and a distal end and an annular implant deployment region therebetween; and a distal joining member for joining the distal ends of the deployment members, wherein the deployment members are expandable by an expansion means to a deployment configuration, and the implant deployment regions of the deployment members are substantially parallel in an expanded configuration. The annular implant can comprise an adjustment mechanism in communication with a releasably attached elongated adjustment tool, whereby the size or shape of the annular implant can be incrementally adjusted.

Minimally invasive system for delivering and securing an annular implant

A delivery device for an annular implant that includes a balloon expansion mechanism and an annular implant having an adjustable dimension. The balloon expansion mechanism includes an inflation tube attached to a non-occluding balloon collar which is supported by trusses radially extending from a trocar. The annular implant further includes a flexible ring core, contiguous coiled spacers, and anchoring blocks. The flexible ring core is adjusted via a cinching mechanism. The anchoring blocks are spaced along the ring core by the contiguous coiled spacers, which keeps the distance between each pair of anchoring blocks equidistant as the ring core diameter is manipulated by the device user. The annular implant can also include gunbarrel elements housed in the trocar. Each gunbarrel element contains a gunbarrel pusher which drives an attachment element into the annular implant and annular tissue.

Inflatable minimally invasive system for delivering and securing an annular implant

A sealable vascular system includes an endovascular implant to be delivered in a compressed or folded state to an implantation site. The endovascular implant includes a tubular implant body and a sealable circumferential collar at said tubular implant body and including a variable sealing device and a control lead traversing from said variable sealing device to a user for controlling said variable sealing device by the user, said variable sealing device and said control lead being cooperatively operable to reversibly expand and contract said sealable circumferential collar such that said sealable circumferential collar is circumferentially adjustable during deployment thereof to achieve a repositionable fluid-tight seal between said sealable circumferential collar and the internal walls of the implantation site.

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Boca Raton, FL, United States of America

John P Cartledge