Mitral valve spacer and system and method for implanting the same
A trans-femoral implant includes an anchor assembly and a balloon assembly configured to be separately delivered to an implant site within a heart. Once delivered, the anchor assembly and balloon assembly may be coupled to form an implant within the heart. The balloon anchor may include a fluid inflatable balloon that may be selectively filled via a balloon filling valve. The balloon assembly may further include a latching mechanism that may couple with a distal end of the anchor assembly, such that the length of the implant may be adjusted within the heart.
1. An implant, comprising:
a balloon spacer assembly, the balloon spacer assembly comprising:
a balloon spacer defining a spacer cavity configured to be expanded from a deflated condition to an expanded condition with a filling fluid; and
a balloon filling valve disposed within and fluidly coupled to said spacer cavity,
wherein said balloon filling valve is configured to be fluidly coupled to a source of said filling fluid and to selectively allow the introduction and withdrawal of said fluid into and out of said spacer cavity;
wherein said balloon filling valve comprises a valve sheath, a valve wire, and a central tube comprising a lumen, an outer wall including a proximal opening and a distal opening there through;
the central tube coupled to a proximal and distal portion of said balloon spacer such that said spacer cavity is defined around said central tube;
the valve sheath disposed around said central tube, the valve sheath configured to resiliently engage an outer surface of said central tube; and
the valve wire extending through said proximal opening and comprising a tip, the valve wire configured to selectively seal and unseal said balloon filling valve depending on the location of the tip relative to a distal edge of said valve sheath.
2. The implant of claim 1 , wherein said valve wire extends from an interior of said lumen of said central tube through said proximal opening, and between said valve sheath and said outer surface of said central tube.
3. The implant of claim 2 , wherein said valve wire is configured to open said valve by causing the formation of an opening between said valve sheath and said outer surface of said central tube as the tip of said valve wire is distally moved relative to said proximal opening.
4. The implant of claim 3 , wherein said valve is configured to close when said valve wire is sufficiently retracted under the distal edge of said valve sheath such that said valve sheath resiliently deforms to seal said opening.
5. The implant of claim 1 , wherein at least a portion of said proximal opening is tapered to an angle ranging from about 15 to about 45 degrees.
6. The implant of claim 1 , wherein said balloon assembly further comprises a proximal end cap coupled to said balloon spacer and said central tube, said proximal end cap including a lumen that is at least partially threaded with threads configured to threadably engage a distal end of a pusher catheter.
7. The implant of claim 1 , wherein said balloon assembly further comprises a latching mechanism coupled to a distal end of said balloon filling valve, said latching mechanism configured to mechanically engage a proximal portion of an anchor assembly; wherein said latching mechanism comprises at least one latch, said at least one latch comprising a resiliently deformable locking element that is configured to resiliently deform outwards in response to an application of force from said proximal portion of said anchor assembly.
8. The implant of claim 7 , wherein said proximal portion of said anchor assembly comprises a latch plug, said latch plug comprising a contoured region for resiliently deforming said locking element and a ridge distal to said contoured region.
9. The implant of claim 7 , wherein said resilient deformable locking element is configured to:
resiliently deform outwards in response to an application of force from a contoured region of a latch plug, thereby permitting said latch plug to move proximally; and
mechanically engage and lock behind a ridge of said latch plug once said contoured region has proximally moved past said resiliently deformable locking element.
10. The implant of claim 7 , wherein said proximal portion of said anchor assembly comprises:
a latch plug comprising a plurality of contoured regions and a corresponding plurality of ridges;
each of said plurality of contoured regions is configured to resiliently deform said locking element outward to permit proximal movement of said latch plug through said latch; and
said locking element is configured to mechanically engage and lock behind each of said ridges of said latch plug once a corresponding contoured region has proximally moved past said locking element.