A multifunctional prosthetic heart valve tester having a circuit of fluid channels, wherein the circuit has a main loop of fluid channel capable of providing a first flow path for a testing fluid. There can be a first branch-off point on the main loop having a first branch channel branching off and fluidly connecting the main loop to a three-way connection. There is a second branch-off point on the main loop having a second branch channel branching off and fluidly connecting the main loop to the three-way connection. A third branch-off point is provided on the main loop having a third branch channel branching off and fluidly connecting the main loop to the three-way connection. There is linear motor and a steady-flow pump disposed on the circuit. Wherein selective shut off of certain channels and selective on/off of the linear motor/steady flow pump allows the device to test the prosthetic valve in the following modes: the steady forward flow mode, steady backward flow mode, pulsatile mode, and hybrid mode.

Prosthetic heart devices may be implanted into the heart with a sensor coupled to the device, the sensor being configured to measure physiological data, such as blood pressure, in the heart. Devices that may employ such sensors include prosthetic heart valves and occlusion devices, although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body with different configurations for attaching to the implantable device, such as apertures for sutures or fingers for connecting to structures of the implantable device. The sensors may provide data that allow a determination of aortic regurgitation or other information indicative of function of the implantable device and patient health during and after implantation of the device.

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.

An implantable device system includes an implantable device, such as an annuloplasty ring, for controlling at least a shape and/or size of a heart valve annulus. The implantable device includes an arcuate body and an adjustment system configured to adjust the shape and/or size of the arcuate body. An adjustment tool is configured to be coupled to the adjustment system so that the adjustment tool can be used to activate and control adjustment of the arcuate body. A sensor system is configured to be coupled to the implantable device. The sensor system includes a first sensor configured to measure physiological data at an inflow portion of the valve annulus when the implantable device is implanted into the valve annulus, and a second sensor configured to measure physiological data at an outflow portion of the valve annulus when the implantable device is implanted into the valve annulus.

The invention generally relates to systems and methods for stress testing to failure tubular mesh devices, specifically, one or more stents or mesh grid tubes. A radial compression method of stress to fatigue is developed by placing a tubular medical implant within a lower than normal compliance test vessel. A radial expansion method of stress to fatigue is developed by placing higher than normal compliance tubes within a tubular medical implant. A method for radial expansion and radial compression is conducted by placing a higher than normal compliance tube through the mesh device and the placing the tube and device within a lower than normal compliance test vessel. Each method is tested on a tester that operates by delivering pulsatile flow with varying pressures, frequencies and testing parameters. Fracture of the test subject is visualized by high speed camera.

Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

This invention relates to the design and function of a retrieval device for a prosthetic heart valve for re-positioning or removal of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system.

A dilation device is provided for modeling mitral regurgitation in a mitral valve that includes an annular housing surrounding an aperture; a first anterior blade mounted to the housing and defining a substantially straight inner edge adjacent the aperture; and a plurality of posterior blades mounted to the housing and defining a curved inner edge adjacent the aperture, the posterior blades movable to dilate a valve mounted to the blades. An annulus of a valve may be sutured to the blades such that valve is disposed adjacent the aperture, and the dilation device may be actuated to cause the posterior blades to dilate a posterior region of the valve.