Abstract:
Prosthetic heart devices may be implanted into the heart with a sensor (400) 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 (100, 2000, 300, 4000) and occlusion devices (5000, 6000), although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body (402) 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.
Abstract:
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.
Abstract:
The invention is directed to a novel method for measuring contraction characteristics of engineered heart tissue constructs (16) which is based on the mechanical coupling of the construct (16) to a support element (8) which comprises or is mechanically coupled to a piezoelectric element (10). An apparatus (1) for carrying out the method of the invention is also provided.
Abstract:
A directional flow valve in a cardiovascular prosthesis test system includes a regurgitant flow passage. Forward flow from a pump through the valve is unrestricted and allowed to pass freely through the directional flow valve. Regurgitant flow is allowed across the directional flow valve to reduce a negative pressure gradient across the prosthetic device. The volume of regurgitant flow is controllable by changing a size of the regurgitant flow pathway.
Abstract:
A ring applicator for applying elastic rings to anatomical tissue during surgical procedures includes an inner member with a forceps movably disposed within a middle tubular member having a distal end configured to hold a plurality of elastic rings in an expanded state and a proximal end with a plurality of longitudinally spaced steps. The middle tubular member is movably disposed in an outer tubular member, and an adjustable stop mechanism is mounted on the proximal end of the outer tubular member to limit axial movement of the outer tubular member relative to the middle tubular member to select which rings are to be ejected. A distal handle is connected with the inner member via slots in the outer and middle tubular members, and a proximal handle is pivotally connected to the middle tubular member via a slot in the outer tubular member. A pusher has a distal end movable between a latched or locked position where the distal end of the pusher protrudes into apertures in the outer and middle tubular members to prevent pivotal movement of the proximal handle and an unlatched or unlocked position where the distal end of the pusher is disengaged from the aperture in the middle tubular member to permit pivotal movement of the proximal handle in order to move the outer tubular member axially relative to the middle tubular member to eject an elastic ring. Distal portions of the outer and middle tubular members are preferably transparent with scale markings formed thereon to allow the surgeon to accurately determine the length of the tissue disposed within the middle tubular member prior to ejecting a ring. A prerelease feature is also disclosed for unlocking the pusher to allow ejection of a ring when the forceps has not been completely withdrawn in to the middle tubular member.
Abstract:
A bi-leaflet prosthetic heart valve (10), comprising an annular body (12) having an upstream edge (14), a downstream edge (16) and a passageway (18) therebetween includes first and second leaflets (20A, 20B) pivotally mounted in the annular body (12). Each leaflet (20A, 20B) has an upstream edge (22A, 22B), a downstream edge (24A, 24B) and a leaflet length (27) therebetween. First and second pivot axes (26A, 26B) associated respectively with the first and second leaflets (20A, 20B) are provided and each leaflet (20A, 20B) rotates about its respective pivot axes (26A, 26B) between an open position allowing blood flow through the passageway (18) of the annular body (12) and a closed position blocking blood flow. The valve (10) is configured such that the leaflets (20A, 20B) have an angle in the naturally open position of more than about 85 DEG .
Abstract:
An implantable device system includes an implantable device (1102), 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 (1004) configured to adjust the shape and/or size of the arcuate body. An adjustment tool (2006) can 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 (3500a) 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 (3500b) configured to measure physiological data at an outflow portion of the valve annulus when the implantable device is implanted into the valve annulus.
Abstract:
Heart valves are provided, comprising a heart valve and a plurality of sensors. Briefly stated, heart valves having sensors, as well as related delivery devices are provided with a number of sensors to monitor the integrity and efficaciousness of the device. Within one embodiment, sensors can be positioned within the heart valve, and/or on one or more surfaces of the heart valve. When the phrase "placed in a heart valve" is utilized, it should be understood to refer to any of the above embodiments, unless the context of the usage implies otherwise. Within certain embodiments, the sensors are of the type that are passive and thus do not require their own power supply.
Abstract:
A prosthetic heart valve (300) includes a collapsible and expandable stent (302) extending from an inflow end (330) to an outflow end (332) and a plurality of prosthetic valve leaflets (308) coupled to the stent. The prosthetic heart valve may also include a sealing ring (350) coupled to the inflow end of the stent, the sealing ring comprising a tube (400) extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering (500) may at least partially surround the tube. The sealing ring may include a first filler (620) positioned within the tube and/or a second filler (610) positioned between the tube and the covering.
Abstract:
A load-controlled accelerated wear testing system to test cardiovascular prostheses that enables a user to tune pulse waveform by adjusting the output loading pressure of a linear motor driving the testing system. A portion of the testing system is open to the atmosphere during testing, allowing a relatively lower threshold pressure necessary to drive fluid across the prosthesis during testing. The contemplated tester can be set up in an array of multiple testers each capable of individual tuning and data-collection without undesirably cross- talking. Its novel feature of single -block construction out of a transparent material also allows direct visualization of the prosthesis during testing.