text:
|Publication number
|Publication type
|Application number
|Publication date
|Oct 18, 1988
|Filing date
|Nov 17, 1986
|Priority date
|Nov 23, 1985
|Fee status
|Also published as
|Publication number
|Hanns Pietsch, Holger Kartheus, Hans-Joachim Holtzmann, Gunther Sachau, Helmut Reul
|Original Assignee
|Beiersdorf Ag
|Export Citation
|BiBTeX, EndNote, RefMan
|Patent Citations (5), Referenced by (147), Classifications (35), Legal Events (5)
|External Links: USPTO, USPTO Assignment, Espacenet
1. Field of the Invention
The invention relates to a heart valve prosthesis consisting of a support ring with at least two, preferably three, commissure supports and flexible (or semilunar) cusps, and to preferred processes for producing them. Such prostheses are used for the replacement of aortic valves or pulmonary valves on human hearts.
2. Background Information
In recent years, a number of cusp valve prostheses have already been disclosed, wherein attempts were made by means to the most diverse design forms to imitate the natural aortic valve or pulmonary valve as closely as possible with respect to function and structure. For example, German Patent Specification No. 2,355,959 describes a semilunar valve for replacing the aortic valve or pulmonary valve, which has the essential structural feature that it is so flexible in its cross-section that it is able to follow the changes in size and cross-section of the base of the aortic valve or pulmonary valve. Although such a highly flexible system has certain advantages, it has the technical functional disadvantage that, in the event of excessive stretching, the cusps can flap over. Moreover, it is difficult to fix the textile suture ring, by means of which the prosthesis is fastened to the heart, to a support ring of such flexibility.
A very important disadvantage of this and other known heart valves is, however, above all that the height of the commissure support is equal to the height of the cusp valves, so that the forces arising during the opening and closing movement of the cusps are applied particularly to the tips of the commissure supports and can cause cracking at these stressed points.
It was therefore the object of the invention to develop a heart valve of the type set out above, which avoids this weak point of the known prosthetic heart valves. In addition, its outline should be shaped such that it does not have any points of attack for blood depositions, thrombi or scleroses and can be reproduced with high accuracy by allowing the use of machines, computer-controlled if possible, in preparation of the molds. It was a further object of the invention to establish the most suitable materials for the preparation of the cusps and the support ring, and to develop an improved process for producing them.
The first-mentioned object is achieved by a heart valve prosthesis for replacing the aortic valve or the pulmonary valve, which prosthesis consists of a support ring with at least two commissure supports in each case and flexible cusps and which is characterized in that the height of the support ring including the commissure supports is less than the total height of the heart valve prosthesis. Preferably, the said height amounts to 20-80%, particularly advantageously 40-60%, of the total height.
This means that the support ring, which preferably consists of a plastic material which is particularly deformable elastically, supports only the lower part of the valve, whereas the upper part of the cusps and their joining zones (the commissures) remain free and flexible. This has the result that the forces which arise on movement of the heart valve and are concentrated at the tips of the commissures, can be distributed harmonically over the free height of the cusp joints, and only a fraction of the forces is applied directly to the support ring.
In order to optimize the flow-dynamic properties of the heart valve, in addition to a longer life, a further feature essential to the invention is that all the construction lines and surfaces of the valve are formed by straight lines, circles, planes and spheres, the transitions of which are adapted by rounding radii, so that all edges, corners and transitions are rounded, in such a way that the mathematical functions underlying these construction lines are steady and fully differentiable.
The equation for calculating the curved upper edge of the support ring according to FIG. 2, following this criterion, is reproduced hereinbelow. Such mathematic equations and functions can be calculated by a person skilled in the art and can also be stored as a working program in computer-controlled machine tools which prepare the molds for producing the heart valve parts.
FIG. 1 is a perspective view of a heart valve according to the present invention.
FIG. 2 is an elevation side view of the support ring of the heart valve as depicted in FIG. 1.
FIG. 3 is a partial cross-sectional view of the heart valve as depicted in FIG. 1.
The further preferred features of the heart valve prosthesis according to the invention are that the prosthesis has three flexible, inwardly curved cusps, similar to the human aortic valve, and correspondingly three commissure supports, the boundary edges of the cusps in plan view showing the outline of a symmetrical three-pointed star, the rays of which each consist of two adjacent, mutually parallel boundary edges. These boundary edges are located on an imaginary spherical surface, in such a way that the point of interception of the three pairs of edges is at the lowest point. Moreover, the boundary edges of the cusps are thickened and rounded in such a way that they have a lobar shape in cross-section. As a result, they have a particularly low flow resistance for the blood stream and a high tear resistance.
Depending on the Shore hardness and breaking strength of the flexible material used for the cusps, the wall thickness of the latter can be 50-1000 micrometers.
In accordance with the general constructional features indicated, according to which all the transitions are rounded, the lower, inner transition of the cusps on the support ring edge is also rounded, and this has an advantageous effect on the stability and load-bearing capacity of this line which is subject to high stress.
Since the commissure supports of the heart valve support ring do not reach, according to the invention, as far as the upper edge of the commissures (joints) between the cusps, their upper region consists of the cusp material. Advantageously, the commissures are reinforced in this region, that is to say the material is thickened here, whereby the heart valve is mechanically stabilized and is protected against flapping over of the cusps.
The support ring (or "stent"), such as is shown in FIG. 2, as an example, and which is designed for three cusps, is a ring having a plane lower edge and a curved upper edge as well as an all-round groove for fixing the suture ring. The curved edge has three points of maximum height, namely the commissure supports, and three points of minimum height, which are each arranged radially symmetrically at an angle of 120�. The all-round groove and all the edges are again rounded, with the exception of the lower inner edge resting planely. In the region of each of the three highest points, there is preferably an orifice, which is used above all for fixing the ring on the machine during the production of the heart valve.
The function of the support ring is to provide support to the flexible cusps and thus to prevent flapping over of the valve and to make provision for anchoring the suture ring.
For suturing the heart valve in the heart, the conventional textile suture rings can be used, which preferably consist of tubular woven or knitted fabrics of cotton, polyester or nylon fibres and are extensible in the radial direction. A suture ring of a polyester (polyethylene glycol terephthalate) fabric having a deflection temperature under load of up to at least 150� C. and a radial extensibility of at least 10% is particularly suitable. Depending on the use of the heart valve, different suture rings are used, above all the three "subanular", "supraanular" or "aortic" versions. The suture ring can be fixed in the groove of the support ring by means of sewing, preferably by glueing.
A further preferred feature, which above all contributes to the longest possible life of the heart valve according to the invention without thrombosis or sclerosis, is that the support ring and the cusps are formed integrally as a result of the plastic skin, from which the cusps are formed, also enclosing the support ring. The groove on the support ring, in which the suture ring is fixed, may here be excepted. This produces a heart valve which is "all of one piece".
In order to achieve this, it was necessary to develop a particularly suitable process for producing the prosthesis and to establish the materials which are most suitable.
The most diverse products can be used as the material for producing the support ring, provided that they are physiologically acceptable and are not degraded by the body. Examples of these are stainless steel, titanium, niobium, tantalum, aluminium, vitreous carbon, fused silica, soda-lime glass, sintered calcium phosphate ceramics, sintered titanium dioxide ceramics, sintered zirconium dioxide ceramics or thermoplastics such as polyethylene glycol terephthalate (polyester), polyethersulphone, polycarbonate, polyurethane, polyethylene or polypropylene having a deflection temperature under Load above 150� C., preferably between 150� and 250� C.
However, polyamides which can contain short glass fibres for reinforcement up to 50% of their weight have proved to be a particularly suitable material. Nylon 6,6 with 15% of glass fibres, which is preferred, can be processed by injection-molding and is sufficiently heat-resistant to withstand the necessary temperatures of 180�-200� C. for brief periods. In addition, it has outstanding mechanical properties, namely: yield stress (according to DIN 53 455) greater than 60 N/mm2, elongation at break (according to DIN 53 455) less than 100%, modulus of elasticity (according to DIN 53 457) greater than 3000 N/mm2, density (according to DIN 53 497) greater than 1, 1 g/m2, moisture absorption (according to DIN 53 479) less than 3%, water absorption at 23� C. (according to DIN 53 495) less than 9% and deflection temperature under load (according to ISO 75, method A) above 150� C.
Hitherto, linear, uncrosslinked polyether-urethanes obtained from difunctional isocyanates, alcohols and amines, have preferably been used for flexible heart valves, these are processed either by the dipping process or the deep-drawing process. These urethanes are commercially available, usually dissolved in dimethylformamide, dimethylacetamide or dioxane/tetrahydrofuran mixtures, as 10-30% solutions.
It has been found in animal experiments, however, that they are not fully resistant to enzymatic and/or hydrolytic degradation in the organism. The reason may be that the amide bonds --NH--CO-- present in the polyurethanes are comparable with the peptide bonds present in proteins.
According to the invention, this problem is solved by the flexible cusps consisting of a three-dimensionally crosslinked polymer material which is insoluble in both water and organic solvents. The important point here is that the material has a low Shore A hardness of 20-80 coupled with a high breaking strength.
Crosslinked polyether-urethanes which have a so-called interpenetrating network (IPN) have proved particularly suitable for this purpose. They have the advantage that, for producing the cusps by the dipping process, an uncrosslinked solution of the polymers can be used and the crosslinking takes place, after the film has dried, by treatment with water.
The polyether-urethanes used are preferably segmented polyether-urethanes such as are described, for example, in U.S. Pat. No. 2,929,804. These polyurethanes have properties which are very highly compatible with blood, but they are degradable in the tissue. However, by adding γ-aminopropyltrisethoxysilane or the corresponding trimethoxy compound, the polyether-urethanes can be post-crosslinked. The result of crosslinking is that they become insoluble in dimethylacetamide, in which the uncrosslinked urethane is soluble when cold. In addition, isopropyl myristate can be added as a lubricant to the solution, in order to obtain better flow on dipping. A preferred mixture consists of 96% of urethane, which has has been freed from sizes and impurities by repeated rinsing in ethyl acetate, 3% of isopropyl myristate and 1% of γ-aminopropyltrisethoxysilane. After the cross-linking reaction, such polyurethanes have a Shore A hardness of 60-80. When this material is used in the dipping process, the wall thickness of the cusps is 80-200 micro-meters.
Another particularly suitable material is silicone rubber, which crosslinks at high temperature (=HTV) and is used in the preferred form of a two-component liquid rubber (liquid silicone rubber=LSR). Such silicone rubbers have a high compatibility with blood and a high fatigue strength in alternate bending as well as a high breaking strength at a low Shore A hardness. After crosslinking, the preferred silicone rubbers have Shore A hardnesses in the range of 25-60, preferably 25-35, a breaking strength of at least 8 N/mm2, a tensile strength of more than 8 MPa (according to DIN 53 504) and an elongation at break of more than 400%.
They can be processed by injection-moulding, and their extremely favourable flow properties with a viscosity of less than 2.106 mPa.s makes it possible to use extremely small cross-sections for gates and runners when building the mould. Since these silicone rubbers, when still uncrosslinked, are also soluble in organic solvents such as hexane, octane etc., gasoline, toluene or xylene, they can also be processed in the dipping process, like the polyurethanes.
The rubbers are formed by the reaction of two linear polydimethylsiloxane components, one component containing free vinyl groups and the other containing Si--H groups. When coming together, these two groups react with one another in the manner of an addition reaction and thus bond and crosslink the two components. Organic platinum compounds are used as the catalyst for the reaction which proceeds under the action of theat.
To improve the mechanical properties, up to about 25% of surface-active silica can be added to such silicone rubbers.
Instead of the silicone rubbers which have to be processed as a liquid, highly viscous two-component silicone rubbers can also be used. These must be premixed in the extruder and are equivalent in their mechanical properties, but processing is more expensive.
It was the object of the production process for the heart valve prostheses according to the invention to carry out the greatest possible number of production steps by machine and also fully automatically. The following production sequence--listed by keywords--meets these conditions:
1. Production of the support ring by injection-moulding
2. Cleaning of the support ring by removing dust particles, greases, etc.
3. Adhesion-promoting pretreament (chemically and/or physically) or the support ring and, if appropriate, application of an adhesion-promoting coating
4. If appropriate, single or repeated dip-coating of the support ring with the cusp material
5. Production of the flexible cusp part by dip-coating or injection-molding with simultaneous molding to the support ring and coating (enveloping) of the support ring with the cusp material. Crosslinking of the cusp material.
6. Fixing of the textile suture ring
7. Sterilization of the heart valve
8. Packaging under sterile conditions.
Explanation of the individual part steps:
As already described, the support ring should preferably consist of thermoplastics. These can be processed very well by the injection-molding process. Compared with the so-called "chip-removing" shaping techniques, injection-molding has the advantage of very accurate reproducibility, if the mold has been produced with corresponding accuracy and the process parameters are carefully monitored and maintained.
Of course, the support ring can also be produced by other processes, but these represent a deterioration as compared with injection-molding.
Attrition particles, traces of lubricants etc. may be present on the support ring from the production process. These are removed preferably by a two-stage washing process. The first washing process is carried out with water and detergent, and the second is carried out with an organic solvent or solvent mixture. For this purpose, the known organic solvents are suitable, inter alia, such as acetone, ethyl acetate, ethanol, isopropanol, trichlorethylene or gasoline. The preferred surface-active substances are anionic compounds such as sodium laurylsulfonate.
After drying, the cleaned support ring is advantageously pretreated in order to obtain better adhesion of the cusp material. The nature of the treatment depends on the materials of which the support ring and the cusps consist. For a combination in which the support ring consists of nylon 6,6 with 15% of glass fibres and the cusps consist of polyurethane, it is sufficient to etch the nylon incipiently with formic acid and to wash with acetone. When this support ring is combined with cusps of polydimethylsiloxane as the flexible material, an adhesion-promoting coating is carried out after etching. It is important that the adhesion of the flexible material to the support ring in the finished heart valve is greater than the breaking strength of this material--that is to say the adhesion is greater than the cohesion--so that, in an extreme case, it will break rather than become detached from the support ring.
According to the invention, the process for the production of the novel heart valve prosthesis by the dip-coating process with a cusp material of polyurethane, that is to say above all from the polyether-urethanes described, is carried out in such a way that the washed, etched and rinsed support ring is dipped several times into a polyurethane solution (solvent: dimethylacetamide) containing a crosslinking agent and, in between, is dried each time to such an extent that the film no longer flows. The γ-aminopropyltrisethoxy-(or trimethoxy)-silane already mentioned is the preferred suitable crosslinking agent. When a coating of 30-50 micrometers thickness has been reached, which as a rule requires 3-5 dipping steps (depending on the viscosity and concentration of the solution), the ring is pushed over a dip mould which precisely fits the cusps and which is machined such that the three cusps with commissures are formed integrally, and the entire workpiece is then subjected to further dipping steps until the desired film thickness of the cusps of 80-200 micrometers has been reached. This requires another 8-20 dipping steps, depending on the concentration and viscosity of the solution.
In order to obtain a uniform layer thickness, drying is carried out with continuous rotation. In order to keep the surface smooth and dust-free, the work is carried out under dust-free laminar airflow conditions, the laminar flow being preheated, the air temperature being 50�-60� C. and the relative humidity being less than 25%. Drying between the individual dipping steps is controlled such that the urethane no longer flows and the new layer incipiently swells, but no longer destroys the old layer. This is accomplished by not completely removing the solvent, but only to an extent of 95% each time. After the desired layer thickness has been reached, final drying is carried out for 24 hours at 80� C, the product is then removed from the mould and, subsequently, crosslinking is carried out for 100 hours in distilled or deionized water at 80� C., solvent residues and other soluble auxiliaries being extracted simultaneously.
When the flexible part is produced in this manner, the shaping of the bead-shaped boundaries of the cusp edges is carried out by "fusion-cutting" either with a heated wire or a laser beam.
This process for the production of the heart valve prosthesis advantageously differs from that described in German Patent Specification No. 3,248,560 in that, inter alia, the support ring is first dipped alone and thus coated on all sides before it is pushed over the dip mold for the the cusps and is further coated together with the latter. This results in a particularly smooth transition from the support ring to the cusps. Moreover, a solid and homogeneous bond in the coating is produced by the only incomplete drying of the polymer films between the individual dipping steps.
The process for the production of the heart valve prosthesis with cusps of silicone rubber by the reaction-injection-mounting process (liquid silicone rubber=LSR injection-moulding) is carried out in such a way that the support ring pretreated with a suitable anchoring layer is placed into the mold and fixed therein by means of pins, the two silicone components are fed via a metering unit into a mixing tube (static mixer), mixed therein bubble-free with the catalyst and, if appropriate, further additives such as silica and are then injected via a needle nozzle into the mold. Vulcanization then takes place in the mold for 10 minutes at 180� C. Lower temperatures can be used if the reaction time is correspondingly extended, but the reaction temperature must not fall below a minimum of 80� C., if the mechanical properties are not to be impaired.
In order to ensure reproducible fabrication and to meet good manufacturing practice (GMP), the temperature and pressure inside the mold should be monitored and recorded during the vulcanization period and a nominal/actual comparison should be carried out continuously. A precondition for such a process is an injection mold with a fabrication tolerance of 7-3 micrometers and a peak-valley height of 5-3 micrometers. Moreover, the mold-parting planes must be outside the direction of blood flow.
This injection mold is designed such that enveloping of the support ring with the silicone rubber layer also takes place simultaneously during injection-molding in addition to the formation of the cusps. The rounded boundary edges of the cusps are produced in this process by appropriate shaping.
After the production of the heart valve, the suture ring is fixed to the prosthesis in the usual way by sewing and/or glueing into the all-round groove in the support ring.
The heat valve prostheses according to the invention, which are distinguished by their special shaping, the materials preferably used and a matching optimized production, show a particularly favorable rheological behavior, high mechanical stability and fatigue strength as well as good compatibility with blood.
The heat valve prosthesis is explained below by way of example by reference to the drawings in which:
FIG. 1 shows a perspective view of the heart valve according to the invention with the support ring 1, the commissure supports 2, the three cusps 3, the cusp boundary edges 4 and the suture ring 5. The support ring is here indicated only by broken lines, since it is not exposed but is coated with the flexible cusp material.
FIG. 2 shows the free support ring 1 with the commissure supports 2, the orifices 6 and the all-round groove 7 for fixing of the suture ring.
FIG. 3 shows a partial cross-section through the heart valve with a cusp 3, the support ring 1 and the groove 7. This shows in particular how the cusp material encloses the support ring, and the fact that the boundary edge of the cusp shown has a rounded, lobar thickened outline.
An equation for calculating the upper edge of the support ring is as follows: ##EQU1## U1 =Transition point 1 U2 =Transition point 2
T0 =Period length=support ring circumference/3
hst =Maximum support ring height
ω0 =2�π/T0
r1 =External radius of support ring
r2 =Centre radius of support ring
r3 =Spherical construction radius
δ=Construction angle
K=Serial variable
x=Position on the developed view of the support ring 0≦x≦ support ring circumference/3
a0 =Radius-dependent auxiliary parameter for construction
It will be appreciated that the instant specification and claims are set forth by way of illustration and not limitation, and that various modifications and changes may be made without departing from the spirit and scope of the present invention.
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|Jun 23, 2010
|Jan 8, 2013
|Edwards Lifesciences Corporation
|Unitary quick connect prosthetic heart valve and deployment system and methods
|Apr 12, 2011
|Jan 8, 2013
|Medtronic, Inc.
|Suture locking assembly and method of use
|Oct 27, 2009
|May 28, 2013
|Edwards Lifesciences Corporation
|Methods of measuring heart valve annuluses for valve replacement
|Jul 1, 2011
|Jun 11, 2013
|Medtronic, Inc.
|Method for implanting a heart valve within an annulus of a patient
|Mar 8, 2011
|Aug 6, 2013
|Medtronic, Inc.
|Two-piece prosthetic valves with snap-in connection and methods for use
|Aug 9, 2010
|Aug 13, 2013
|Edwards Lifesciences Corporation
|Contoured sewing ring for a prosthetic mitral heart valve
|Aug 12, 2005
|Aug 27, 2013
|Edwards Lifesciences Corporation
|Contoured heart valve suture rings
|Dec 20, 2002
|Oct 8, 2013
|Medtronic, Inc.
|Biologically implantable prosthesis
|Aug 10, 2009
|Nov 5, 2013
|Edwards Lifesciences Corporation
|System, device, and method for providing access in a cardiovascular environment
|Jul 6, 2009
|Dec 10, 2013
|Medtronic, Inc.
|Attachment device and methods of using the same
|Sep 22, 2011
|Jan 7, 2014
|Medtronic, Inc.
|Biologically implantable prosthesis and methods of using the same
|Jun 23, 2011
|Feb 4, 2014
|Edwards Lifesciences Corporation
|Systems for rapidly deploying surgical heart valves
|Oct 10, 2012
|Apr 15, 2014
|Edwards Lifesciences Corporation
|Unitary quick-connect prosthetic heart valve deployment methods
|Aug 3, 2011
|Jun 10, 2014
|Medtronic, Inc.
|Methods of using a prosthesis fixturing device
|Apr 30, 2007
|Sep 2, 2014
|Medtronic, Inc.
|Multiple component prosthetic heart valve assemblies and methods for delivering them
|Sep 20, 2011
|Sep 30, 2014
|Edwards Lifesciences Corporation
|Prosthetic heart valve frame with flexible commissures
|Jul 1, 2011
|Dec 2, 2014
|Thoratec Corporation
|Implantable heart assist system and method of applying same
|May 10, 2011
|Mar 24, 2015
|Edwards Lifesciences Corporation
|Prosthetic heart valve
|Dec 21, 2012
|Apr 14, 2015
|Edwards Lifesciences Corporation
|Unitary quick-connect prosthetic heart valve deployment system
|Oct 25, 2012
|Apr 14, 2015
|Edwards Lifesciences Corporation
|Quick-connect prosthetic heart valve
|Nov 13, 2012
|Jul 14, 2015
|Edwards Lifesciences Corporation
|Anchoring device for replacing or repairing a heart valve
|Mar 12, 2013
|Sep 8, 2015
|Edwards Lifesciences Corporation
|Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves
|Feb 10, 2014
|Sep 22, 2015
|Sorin Group Italia S.R.L.
|Prosthetic vascular conduit and assembly method
|Apr 18, 2014
|Oct 13, 2015
|Edwards Lifesciences Corporation
|Prosthetic mitral valve
|Mar 3, 2010
|Feb 2, 2016
|Edwards Lifesciences Corporation
|Prosthetic heart valve system
|Mar 11, 2015
|Apr 5, 2016
|Foldax, Inc.
|Replacement heart valves and their methods of use and manufacture
|Nov 25, 2013
|Apr 19, 2016
|Edwards Lifesciences Corporation
|Conformal expansion of prosthetic devices to anatomical shapes
|Nov 22, 2013
|May 10, 2016
|Medtronic, Inc.
|Heart valve assemblies
|Mar 12, 2013
|Jun 21, 2016
|Edwards Lifesciences Corporation
|Rapidly deployable surgical heart valves
|Mar 26, 2009
|Aug 23, 2016
|Genomnia Srl
|Valve prosthesis for implantation in body channels
|Jan 23, 2013
|Sep 13, 2016
|Edwards Lifesciences Corporation
|Methods of implant of a heart valve with a convertible sewing ring
|Jun 12, 2014
|Oct 18, 2016
|Edwards Lifesciences Corporation
|Cardiac implant with integrated suture fasteners
|Jan 27, 2014
|Nov 29, 2016
|Edwards Lifesciences Corporation
|Rapidly deployable surgical heart valves
|Jun 19, 2015
|Nov 29, 2016
|Edwards Lifesciences Corporation
|Surgical heart valves identifiable post-implant
|Jan 30, 2015
|Jan 10, 2017
|Foldax, Inc.
|Replacement heart valves and their methods of use and manufacture
|Apr 2, 2015
|Jan 24, 2017
|Edwards Lifesciences Corporation
|Method for manufacturing high durability heart valve
|May 11, 2011
|Jan 31, 2017
|Edwards Lifesciences Corporation
|Low gradient prosthetic heart valve
|Dec 15, 2014
|Jan 31, 2017
|Edwards Lifesciences Corporation
|Rapid deployment prosthetic heart valve
|Apr 10, 2015
|Feb 7, 2017
|Edwards Lifesciences Corporation
|Systems for quickly delivering a prosthetic heart valve
|Apr 29, 2015
|Mar 7, 2017
|Edwards Lifesciences Corporation
|Holder and deployment system for surgical heart valves
|Feb 7, 2013
|Mar 28, 2017
|Edwards Lifesciences Corporation
|Methods of measuring heart valve annuluses for valve replacement
|Oct 12, 2015
|Aug 15, 2017
|Edwards Lifesciences Corporation
|Prosthetic mitral valve
|Oct 10, 2002
|Feb 20, 2003
|Andersen Henning Rud
|Valve prosthesis for implantation in the body and a catheter for implanting such valve prosthesis
|Aug 31, 2002
|May 8, 2003
|Inflow Dynamics Inc.
|Primarily niobium stent
|Dec 28, 2001
|Jul 3, 2003
|Kruse Steven D.
|Fatigue test for prosthetic stent
|Apr 25, 2002
|Jul 3, 2003
|Medtronic, Inc.
|Heart valve system
|Feb 10, 2003
|Jul 31, 2003
|Inflow Dynamics Inc.
|Metal stent with surface layer of noble metal oxide and method of fabrication
|Oct 2, 2001
|Jan 22, 2004
|Josef Jansen
|Cardiac valve prosthesis, especially mitral cardiac valve and method for producing the same
|Jan 2, 2003
|Feb 5, 2004
|Medtronic, Inc.
|Prosthetic heart valve system
|Dec 5, 2003
|Jul 29, 2004
|Carpentier Alain F.
|Flexible heart valve and associated connecting band
|Mar 10, 2003
|Sep 16, 2004
|Daignault Kenneth J.
|Medical stent and related methods
|Oct 28, 2004
|May 5, 2005
|Dongbu Cao
|Flexible heart valve
|Aug 12, 2005
|Jan 12, 2006
|Huynh Van L
|Contoured heart valve suture rings
|Nov 2, 2004
|May 4, 2006
|Chinn Joseph A
|Attachment of a sewing cuff to a heart valve
|Apr 11, 2006
|Aug 31, 2006
|Johnson Keith M
|Heart valve system
|May 3, 2006
|Sep 7, 2006
|Torsten Scheuermann
|Primarily niobium stent
|Jan 11, 2006
|Oct 12, 2006
|Salvador Marquez
|Stress absorbing flexible heart valve frame
|Apr 6, 2005
|Oct 12, 2006
|Salvador Marquez
|Highly flexible heart valve connecting band
|Jan 23, 2006
|Oct 19, 2006
|Johnson Keith M
|Prosthetic heart valve system
|Jan 24, 2007
|Aug 2, 2007
|Salumedica, Llc
|Methods of producing pva hydrogel implants and related devices
|Feb 15, 2008
|Jun 5, 2008
|Daignault Kenneth J
|Medical stent
|Dec 7, 2007
|Jun 19, 2008
|Boston Scientific Scimed, Inc.
|Metal Stent with Surface Layer of Noble Metal Oxide and Method of Fabrication
|Sep 16, 2008
|Mar 19, 2009
|Medtronics, Inc.
|Heart valve holder assembly for use in valve implantation procedures
|Feb 17, 2009
|Aug 6, 2009
|Johnson Keith M
|Prosthetic Heart Valve System
|Mar 26, 2009
|Oct 8, 2009
|Ab Medica S.P.A.
|Valve prosthesis for implantation in body channels
|Dec 10, 2009
|Jun 24, 2010
|Edwards Lifesciences Corporation
|Quick-connect prosthetic heart valve and methods
|Mar 4, 2010
|Jun 24, 2010
|Edwards Lifesciences Corporation
|Holder for flexible heart valve
|Jun 23, 2010
|Dec 30, 2010
|Edwards Lifesciences Corporation
|Unitary Quick Connect Prosthetic Heart Valve and Deployment System and Methods
|Feb 10, 2014
|Jul 3, 2014
|Sorin Group Italia S.r.I.
|Prosthetic vascular conduit and assembly method
|Apr 14, 2000
|Oct 26, 2000
|Sulzer Carbomedics Inc.
|Heart valve leaflet with scalloped free margin
|Apr 17, 2000
|Oct 26, 2000
|Sulzer Carbomedics Inc.
|Improved heart valve leaflet
|Jul 18, 2000
|Jan 25, 2001
|Sulzer Carbomedics Inc.
|Heart valve leaflet with reinforced free margin
|Sep 19, 2001
|Mar 28, 2002
|St. Jude Medical, Inc.
|Valved prostheses with reinforced polymer leaflets
|U.S. Classification
|623/2.19, 623/2.13, 623/900
|International Classification
|Cooperative Classification
|European Classification
|Nov 17, 1986
Owner name: BEIERSDORF AG, UNNASTRASSE 48 D-2000 HAMBURG 20 GE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:PIETSCH, HANNS;KARTHEUS, HOLGER;HOLTZMANN, HANS-JOACHIM;AND OTHERS;REEL/FRAME:004696/0078
Effective date: 19861110
|Aug 22, 1989
|Certificate of correction
|May 20, 1992
|Maintenance fee reminder mailed
|Oct 18, 1992
|Lapse for failure to pay maintenance fees
|Dec 22, 1992
|Expired due to failure to pay maintenance fee
Effective date: 19921018


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I'm meeting a friend at the Bookfair tomorrow. Any lunch recs for Needham Street/Highland Ave or (very) nearby? I'd love to go further afield, but my friend is coming a long distance and is not familiar with the area. Even if you have a rec for a particular good item in a not so good place, that would be helpful, too!
Thanks in advance, hounds!

subset: commoncrawl


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Renew your membership
If you're already a member, you may renew here, online. Alternately, you may start your renewal on this page, then mail your check to us or pay by credit card, check, or cash at one of our Panels or Seminars. You'll find all payment info on the next page after you submit this form.
If you joined as a Student and are still a student, you may renew as one. Renewal is $25. We will ask for verification of your school. If you are no longer a student, select the regular renewal option.
If you're a Regular member, we have two renewal options for:
- You may renew your membership for $65. The renewal will date back to your expiration date. For example, if your membership expired March 1 and you renew on March 10 or June 10 or whenever, your $65 renewal is effective March 1 and your expiration date remains March 1.
- You may pay $85 for a new membership. The new membership would be effective when we receive your payment. Your new expiration date would then be the first day of the following month.
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The only information we require is your name and email. All else is optional.
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ABC announced they are moving forward with Time After Time Season 1 which is a new TV series that will feature H.G. Wells (Freddie Stroma) vs. Jack the Ripper (Josh Bowman). Kevin Williamson (The Following TV series, Scream (1996)) wrote ABC's Time After Time Season 1 based on Nicholas Meyer's Time After Time (1979) featuring Malcolm McDowell as H.G. Wells and David Warner as Jack the Ripper. Watch the teaser trailer below. Marcos Siega directed the pilot episode.
"Time After Time" (2017)
Synopsis: The adventures of young H.G. Wells and his time machine.
Directors: Steve Shill, Marcos Siega
Genres: Drama, Sci-Fi
Runtime: 60
Producers: Daniel T. Thomsen, Marcos Siega, Kevin Williamson, Ani Arutyunyan, Jeffrey T. Bernstein, Gabrielle G. Stanton
Musicians: Jeff Russo
Editors: Rosanne Tan, Carmen Morrow, Vincent Tabaillon, Shelly Westerman
You May Also Like…
The Red Queen Kills Seven Times (1972) - Trailer
Titan A.E. (2000) - Trailer
After.Life (2009) - Trailer


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Acne Scar Treatments
If you have serious problem about acne, you should get your acne treated immediately or it will become scars in the near future. You have to choose the suitable acne products which can be a great solution for your acne problem. While using the acne products, you are about preventing the acne appears, as well as prevent the scarring. Nowadays, many website in the internet offering methods and products for acne scar treatments. However, I must told you that not all of those services may solve your problem. Because sometimes they just want to sold their product and don't know exactly about the products offered on their website. So, I'm looking for a company which may helping me solving my acne scar problem through the internet. And then I have found a great website that providing the products for acne scar treatments. While browsing through that company's website, I can see the complete description along side with the prices. However, I believe that they have an affordab... Read More
Bad Nose Job Repair Photographs
Have you ever imagine what would you look like when you're about using any cosmetic surgery? Very well, if you want to modify your face much better then you should find the best company that may helping you on your cosmetic surgery. As I've mentioned above, finding the great and suitable place for your cosmetic surgery is not easy as you have thought. For example, if you want to make your nose more sexy, then you have to find the suitable place for you to start. Although there are many services providing you with their cosmetic surgery, but you should choose wisely because it's all about your nose. Just take a look at this bad nose job repair photographs. You can see many people are satisfied with the cosmetic surgery. Their nose looks more sexy and there are no dangerous side effects for this. Well… if you live in the Chicago area, have you ever heard about Dr. Steven Dayan? He is specializes on facial cosmetic surgery and very famous for his surgery, as you ca... Read More
Plastic Surgeons in Chicago Illinois
Many people are not satisfied enough with their own image. So, they always want enhancing their beauty in an expert surgeon of a high class medical clinic. Although the cost is not cheap enough, but they will do anything for their beauties sake to make it look perfect. Nowadays, it is not a secret anymore that some celebrities are enhancing their beauty with going into plastic surgery. It may increase their confidence when they had facing with other people. And that's not happened only on celebrities. Common people also enhancing their beauty to make they become more prettier than ever. The most methods that can be used to enhance the beauties are plastic surgeons in Chicago Illinois. However, if you are living in Chicago area or near this place, then you can raising up your confidence with plastic surgeons in Chicago Illinois. The surgeon in this area will be done by an expert and full experienced plastic surgeon named Dr. George Moynihan. Dr. Moynihan are specialized in plastic... Read More
The Secrets of Yoga
Actually, the word "Yoga" is derived from the Sanskrit word "yeund" which means to "yoke" or "join". When I've read the Hindu philosophy, this word has meaning a union of the individual soul (Jivatma) with universal consciousness (Parmatma). In other words, the meaning is the union of the body with the mind, and mind with the soul. However, this art defines many methods and practices which may help an individual attain divine realization. I'm very interested in Yoga… so I'm seek many information about this art. I want to know more about yoga pose and exercise guide which may result to the health of my body. While looking for the source for yoga in the internet, I have found a site that providing me with the most complete information about yoga pose and exercise guide. I'm very glad to find TheSecretsofYoga. A site portal that gives me many useful and valuable information that can be used to start my experienc... Read More
Washington DC Eyelid Surgery
I believe everybody had a dream for remaining young forever. Most of people don't wants growing old and looks old. That's the common situation that always be faced by people in the world. Over the years, many experts and scientists have tried to concoct the perfect formula that would help people to keep young forever. However, they have failed and can't reach their goals. Based on this fact, many people keep trying various methods to make they are still looking young. The agings and the tiredness always can be seen easily in the face. And most people have facial skin that look wrinkled and beat up, while others have bags under their eyes. It is very interesting to take a further notice. The eyes are the first areas that may show and reveal any tired and aging sign. According to this condition, many surgical and non-surgical expert are working hard to solve the problem about that, includes Washington DC eyelid surgery. Nowadays, the famous and popular methods that can ... Read More


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TRANSPORTATION EQUITY ACT: A LEGACY FOR USERS -- (House of Representatives - April 01, 2004)
The SPEAKER pro tempore. Pursuant to the order of the House of Tuesday, March 30, 2004, and rule XVIII, the Chair declares the House in the Committee of the Whole House on the State of the Union for the consideration of the bill, H.R. 3550.
Mr. UDALL of Colorado. Mr. Chairman, I rise in support of TEA LU. However, I am disappointed that it does not include language to close a dangerous loophole in a 30-year-old law that allows school districts to use 15-passenger vans to transport students to and from athletic trips and other school activities.
I have introduced legislation, H.R. 1641, to remedy the problem. It would prohibit the purchase, rental or lease of 15-passenger vans for use to transport students. I understand that the ranking member is amenable to working with me and others in conference to ensure we put an end to this practice that puts schoolchildren's lives on the line every day.
Is this the understanding of the gentleman from Minnesota?
Mr. OBERSTAR. Mr. Chairman, will the gentleman yield?
Mr. UDALL of Colorado. I yield to the gentleman from Minnesota.
Mr. OBERSTAR. Mr. Chairman, the gentleman from Colorado has identified an issue that has been highlighted by the
National Transportation Safety Board. I am in full sympathy with the gentleman, and we will work to accomplish that objective.
Mr. UDALL of Colorado. Mr. Chairman, I thank the gentleman from Minnesota for his remarks and look forward to working with him.


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Our breakfast spies have reported with certainty that there are now not one, but two spanking-new Waffle House franchises within a fifteen-minute drive of Downtown New Orleans. (Up until recently, anyone wanting food smothered, covered or chunked had to drive to Baton Rouge, or an equal distance along Highway 90 West.) The restaurants are located at the Read Blvd. exit of I-10 in New Orleans East (pictured), and at 3429 Paris Rd. in Chalmette. Both, of course, have the full selection of Waffle House songs on the jukebox. We were also pleased to see a new condiment on the table: "Casa de Waffle" hot picante sauce.
So this is a little old, but between eating, football and shopping there wasn't much else to be done. On Thanksgiving night, Chris Paul and company made their
firstsecond appearance on national TV facing off against the Denver Nuggets on TNT. Needless to say, CP3 and his boys left a favorable impression on Marv Albert and Doug Collins and anyone else who was able to endure the tryptophan and stay up past 1 a.m. EST on Thanksgiving.
Five years ago the restaurant company I was working for in New York took on the laborious task of turning all seven of our restaurant's voluminous international wine lists into strictly American wine lists. It was just shy of a monumental task which our 29-year-old wine director accomplished by first finding wineries in each state, then by tasting a tremendous amount of wine, some of which was incredibly bad. Fortunately there was a lot that was also very good.
As it happens Louisiana is proud to be home to six wineries - but only one of those wineries produces wine from grapes, a primary necessity in selecting the wine for our wine lists. Thru no regional nepotism, John Seago's Pontchartrain Vineyards wine was selected as one of the wines we would not only have on our wine lists around the country but would also be featured at a press-heavy kickoff luncheon in Manhattan. There were 100 American wines opened at this lunch event and American wine all-stars such as Michael Mondavi, Jess Jackson, Bo Barrett (of Bottle Shock fame) and Doug Schafer poured wines side by side winemakers like John Seago.
John was wonderful. He is an avuncular character well-versed not only on wine and Louisiana but how those two things intermingle. As well he is quite a history buff and knows a tremendous amount about wine's history in America. His quest to start a vineyard in Louisiana is enough to fill several hundred pages alone.
This Saturday, November 29th, from noon to 5pm, Pontchartrain Vineyards is hosting a Harvest & Holiday celebration with food, hayrides, barrel tastings, tours, music and, of course, wine. Adults $7, Children under 12, free. This is a great opportunity to meet and mingle with the people of Pontchartrain Vineyards and to taste wine local to Louisiana that doesn't start with "strawberry" or "muscadine"
Click here for directions.
As frustrating, infuriating, aggravating, and bass-ackwards as this crazy town can be at times, I think we're all fortunate to be living here...and to even be here. At a time with such great hope and promise for the country, and at a time when some people can only spread pain and suffering in the world, we've got a good deal for which to be grateful...and all of us at Gambit are grateful for you.
Have a wonderful Thanksgiving, and take to heart the message in this wonderful video from the Preservation Hall Jazz Band and Clint Maedgen. It's been around a while, but it never gets old, and if it's new to you, enjoy it:
Photo by Jonathan Bachman
In an effort to give Hornets fans the best look at their favorite team, I'll be showing a series of video interviews with various New Orleans Hornets players in Gambits Best of theme. Some will be short and sweet while others will be a bit longer and still sweet. Today I present to you the Best of Mike James. He talks about golf, his connection with pit bulls and has a couple words for his friend, Tyson Chandler. And in case you're wondering, that music you hear is Sick Like Sinatra.
Hit the jump for the video and Happy Thanksgiving everyone (P.S. I'm thankful that I get to film stuff like this).
He is surly, unkempt, crass, oafish and one of the New Orleans best-loved fictitious citizens. Ignatius J. Reilly has been entertaining readers since he was first unleashed upon the Crescent City in John Kennedy Tooles 1980 novel A Confederacy of Dunces.
But his personality, among other things, was too big to be contained within the pages of Tooles novel, and his immense popularity has tempted many actors and directors to try and bring the character to the silver screen. While a film adaptation is still pending, actor and WWL talk show host John Spud McConnell has successfully filled Ignatius green hunting cap on stage. He reprises the role of the bayou buffoon, closed valve and all, in a benefit for the Tenessee Williams Festival at Le Chat Noir on Sunday, Nov. 30. (Two shows, 3 p.m. & 6 p.m.; tickets $50 general admission, $35 students, includes $5 drink credit)
By purchasing an analog-to-digital converter box, I assumed Id be freed from the shackles of a snowy-fuzz pair of bunny-eared antenna. Instead, though I have a little-more-than-limited cable, the picture comes through like a blurry YouTube video on dial-up.
But every once in a while, I come across basic-cable infomercial gems like this:
Im not sure what kind of cancer this thing is capable of producing, but Im sure millions among the Thanksgiving-panicked masses are at least tempted by a two-hour turkey.
I just hope my Louisiana neighbors stick to what they know best turkey fryers. Im not sure if Id want infrared lasers anywhere near my more than likely lead-contaminated New Orleans apartment.
We at Gambit Weekly are well aware that our compatriots at 3800 Howard are forbidden under pains of death of even mentioning our publication in the august pages of The Times-Picayune, but this morning's graphic by Times-Pic art critic Doug MacCash took things to a new level:
The piece by French artist Anne Deleporte is actually titled Gambit; Tulane University art preparator Alexis Stahl explained to me that Deleporte used pages from Gambit in its construction.
But somehow the T-P saw the need to change the artwork's title to "Surreal wallpaper" in its infographic review rather than print the dreaded G-word on the front page of the Living section.
God only knows what they're going to do next year when Ethan and Joel Coen's next movie, Gambit, opens in New Orleans. "Untitled Coen Brothers Project," anyone?
Photo by Wlodi, courtesy of Flickr.com
Theres good news and bad news for Louisianans in a recent report on cancer in the United States. For men, the good news is that lung cancer and the deaths associated with it are decreasing, but for women the rate of lung cancer continues to rise and so does the death rate.
A well-researched paper, Annual Report to the Nation on the Status on Cancer, 1975-2005, Featuring Trends in Lung Cancer, Tobacco Use, and Tobacco Control, is for the first time reporting a decline in both cancer incidence and death rates in the U.S. One of the papers co-authors is Dr. Xiao Cheng Wu, an associate professor and the assistant director of the Louisiana Tumor Registry at LSU Health Sciences Center New Orleans School of Public Health. The paper is a collaboration between the American Cancer Society, the Centers for Disease Control, and the North American Association of Central Cancer Registries.
The report will be published on December 2, in the Journal of the National Cancer Institute and states that both incidence and death rates from all cancers combined are decreasing significantly in men and women overall and in most racial and ethnic populations. These decreases are largely driven by declines in the three most common cancers in men (lung, colorectum, and prostate) and in two of the three leading cancers in women (breast and colorectum), combined with a leveling off of lung cancer death rates in women. Although the national trend in female lung cancer death rates has stabilized since 2003, there is prominent state and regional variation. Lung cancer incidence and/or death rates among women increased in 18 states, 16 of them in the South or Midwest. California was the only state with decreasing lung cancer incidence and death rates in women.
A Cable Card is a computerized satellite TV approval and translating framework gadget that looks…
Our Cannabis Oil is Pure and potent.Never watered down or diluted,just 100% pure cannabis oil…
Miss Carver's comments on National politics, why is he so "quiet" in recent years
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I went to see Stevie Nicks at the Minnesota State Fair in August. We had…
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If this was his test, he failed and he will be justly rewarded.
tired of being punished over and over? then get deported so you won't get tired…
Hi Nice List, also find the best Indian restaurants here http://localservices.sulekha.com/restaurants-in-milwaukee-wi
nice one
Oh wow, I didn't know she had made more music. I just heard her music…


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When I say "depression", what kind of picture do you conjure up in your mind? Is it a picture of a man pensively gazing out a window in a dark room? Or a woman crying inconsolably? You wouldn't be wrong to think that. A lot of people living with depression may do those things. Depression is cruel and unkind, but picking depression out of a crowd may be harder than you think. For me, and others too, depression does the majority of its work behind the scenes. There is much that you don't see. I think seeing depression only as the stereotypical picture of it is dangerous. While in private I do become tearful and overwhelmed by depression, in public I use every effort I can muster to feign normalcy. The rest of this blog is a juxtaposition of what you see and what you don't see with someone living with depression. The examples used vary between the depressive episode I experienced as a teen as well as later on as an adult.
What you see: A 15-year-old kid that shows up for class joking with friends
What you don't see: A 15-year-old kid with depression saying to her, "Why do you have to laugh like that? That's way too loud. Can't you see you're annoying everyone? You're so stupid. They only let you sit with them because they feel bad for you."
What you see: A girl who calls in sick saying, "It must be that bug that's going around."
What you don't see: A girl that just cannot be willed to leave her bed. Depression saying, "God, you're such a failure. Everyone else makes it to work, you have no excuse to be this way. Just another reason why you're completely worthless."
What you see: A girl responding, "Yeah I'm fine. Just really tired today."
What you don't see: Leaving the confines of my room took all the strength I could find within myself today. Despite the effort I still hate myself and am melting in my own self-loathing.
What you see: A girl watching TV at home.
What you don't see: A girl that just doesn't enjoy seeing friends. Or doing anything beyond lying down – because it just isn't fun. What's the point anyway?
Depression takes many forms and can remain beneath the surface for a long time before friends or family can notice. A lot of the struggles I have experienced are not always easily visible. I think it's important for people to remember that you don't see everything about someone's experience. It can be hard to find the right words to describe the feeling of all the thoughts that run through my head. The picture below is the best cartoon that describes depression, at least for me. Depression Land is a not-so-fun place that I didn't want to go to, and is difficult to leave.
About Cassie S
25 year old psychiatric nursing student. I live with depression off and on and have since I was 12. Learning to ride the waves as they come. I'm an introvert who enjoys reading, art, and spending time with friends and family. I also really enjoy being active: running, biking, hot yoga, dodge ball and slo-pitch are a few favourites.


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Description:Trashy bitches act wild and dirty while filming in hardcore FFM threesome porn clip. Blonde hoochie is penetrated in a missionary position. She gets screwed deep and rough.
Category:+18 only (Adult)
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As cute as this thing is (and I downloaded Windy night too) I would rather have the space than have it on my phone. Does anyone know where these files are stored. I've done multiple google searches and can't find anything except some people are a bit upset like me that it just installs without asking and I was seeing people say you couldn't delete it (but I assume they aren't rooted). Since I'm rooted if I can find it I'll save it to my PC but clear the space on the phone. BTW Spotlight and this data take up 318 Megabytes!
Thanks, I did see that way to clear it but was hoping to copy the files to my PC in case I wanted to use them again at some point. Got 10 hard drives + and lotsa space in the main PC
---------- Post added at 03:15 PM ---------- Previous post was at 02:41 PM ----------
I also tried busybox linux 'find' command using wildcards on bug but apparently that's not even what it uses for a name. Maybe if I knew the file extension type of these files I could find it but I don't know those yet....
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|By Kevin Benedict
Article Rating:
|May 12, 2017 11:00 AM EDT
For executives, transforming an enterprise is always difficult, but when an enterprise is highly profitable - digital transformation is even harder. The temptation to follow the maxim, "Don't fix what isn't broken," is just too compelling. "When you average 8% same-store sales [growth] for 35 years, it can breed a sense of, 'Why do we need to change? Things are working,'" John Mackey, CEO of Whole Foods, said in a recent interview with "The Wall Street Journal." Today, however, Whole Foods is struggling to compete with other lower-priced grocery stores that have embraced organics and healthier foods. If you take your eye off the game for a second, consumers will change directions on you.
The challenge enterprises are faced with today is that digital technologies are changing the way consumers behave faster and in different ways than executives have ever seen before. Today's profits can hide or mask the serious problems of tomorrow.
Competitors can't compete, and leaders can't lead if they don't know the rules of the game. Understanding how the game is played, and how points are scored, are key to any competition. In the age of digital transformation these are some of the key rules to learn in order to score:
- Data is the modern commercial playing field, information dominance is your goal, those that can "act and with speed" have the advantage over those which cannot.
- Advantages in the speed of data-driven decision-making, automation, robotic process automation will dictate the winners of tomorrow.
- Complexity is the enemy of agility, and acts as poison from the past.
- It takes an optimized Information Logistics Systems (OILS) to support real-time digital interactions.
- Faster operational tempos and information logistics systems - open up a plethora of new business opportunities and business models.
- Precision and real-time data beats estimates and conjecture.
- Digital interactions require real-time business operational tempos.
- Bad data will make the smartest systems dumb.
- Competitive advantages from new technologies depreciate quickly - so act fast.
- Situational awareness enables management to focus on the knowns, rather than the unknowns.
- Demand for real-time digital customer interactions increases the need for contextually relevant and personalized user experiences and digital transformation across all systems and processes.
- Data has a shelf life, and the economic value of data diminishes quickly over time, and the more data that is collected analyzed and used, the greater the economic value it produces in aggregate. In addition, the economic value of data multiplies when combined with context and right time delivery.
- Digits can be changed faster than the human mindset.
These rules not only help you understand how to compete and win, but they should also guide enterprises in their development of a digital transformation doctrine - a guiding and unifying statement as to the purpose, desired effect and outcome that is wanted.
These rules not only help you understand how to compete and win, but they should also guide enterprises in their development of a digital transformation doctrine - a guiding and unifying statement as to the purpose, desired effect and outcome that is wanted.
I invite you to watch my latest short video on digital technology trends and strategies:
Download the full report with charts and data sources here:
Kevin Benedict
Senior Analyst, Center for the Future of Work, Cognizant
View my profile on LinkedIn
Follow me on Twitter @krbenedict
Subscribe to Kevin's YouTube Channel
Join the Linkedin Group Strategic Enterprise Mobility
Join the Google+ Community Mobile Enterprise Strategies
***Full Disclosure: These are my personal opinions. No company is silly enough to claim them. I am a mobility and digital transformation analyst, consultant and writer. I work with and have worked with many of the companies mentioned in my articles.
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Amplify - Master Services Agreement
THIS MASTER SERVICES AGREEMENT ("MSA") is entered into by you ("Client") as evidenced by your use of the Services (defined below). "Client" shall include Client's corporate subsidiaries, as well as corporate parents, affiliates, and other related entities (collectively, "Affiliates") approved by Amplify to receive Services under this MSA. For purposes of this MSA the term "Amplify" shall mean Amplify Professional Services. Amplify and Client agree to the following terms and conditions:
1 All services provided by Amplify under this MSA (the "Services") will be described in one or more Statements of Work ("SOW").
2 The MSA and each SOW will be interpreted as a single agreement, independent of each other SOW, so that all of the provisions are given as full effect as possible. In no event will the description of Services under any SOW be deemed by implication or otherwise to exclude any Services described in this MSA or another SOW.
a In the event of a conflict between the terms of the MSA and a SOW, the terms of these documents will be interpreted according to the following order of precedence: (1) SOWs and (2) the MSA.
1 Prices. Pricing is determined by scope and complexity of each individual SOW. Amplify and Client will agree to project pricing and methodology in advance of project execution.
2 Additional Fees; Taxes. Client shall be responsible for all applicable taxes and fees assessed or imposed upon the Services provided or the amounts charged under this MSA, including any sales, use, excise, value-added, or comparable taxes, but excluding taxes related to Amplify's net assets or net income or for which Client has provided a valid resale or exemption certificate. Should any payments to Amplify become subject to withholding tax, then Client shall deduct these taxes from the amount owed to Amplify and pay the taxes to the appropriate tax authority in accordance with the laws thereof. Client shall promptly provide Amplify with receipts or other applicable evidence of substantiating the payments as required under the laws of the applicable taxing authority. Amplify shall not be liable for any withholding tax, penalty, or interest due as a result of Client's failure to withhold any applicable tax.
3 Invoicing and Payment. Client's payment terms will be Due On Receipt (DOR), subject to continuing credit approval by Amplify. Client will pay Amplify in US dollars, as invoiced by Amplify. Additional charges may apply if Client requests services that are performed outside contracted hours or are beyond the normal coverage for the particular service.
4 Nonpayment. For invoices not paid within thirty (30) days of the invoice date, Amplify reserves the right to charge Client a late penalty charge of one and a half percent (1.5%) per month applied against undisputed overdue amounts, or the maximum rate permitted by law, whichever is less. In addition, Amplify, without waiving any other rights or remedies to which it may be entitled, shall have the right to suspend or terminate the Services until such payment is received and may decide not to accept additional orders from Client and/or seek collection of all amounts due, including reasonable legal fees and costs of collections. Amplify shall have no liability to Client for any such suspension or termination of Services, or non-acceptance of orders.
1 This MSA has a one year term, beginning on the the date executed. The MSA will automatically renew on the anniversary of the Effective Date for subsequent one year terms ("Term") unless terminated in accordance with Section 4 below.
1 Either party may terminate this MSA for convenience by providing at least thirty (30) days prior written notice to the other. Termination of this MSA for convenience will not terminate any outstanding SOW that provides for a specific term over which the Services are to be provided. In such case, this MSA, as incorporated into the SOW, and the SOW that provides for a specific term will remain in effect for the remainder of such term. Upon termination of this MSA, all rights and obligations of the parties under this MSA will automatically terminate except for rights of action accruing prior to termination, payment obligations and any obligations that expressly or by implication are intended to survive termination.
2 Either party may terminate an individual SOW if the other party commits a material breach of such agreement and the breach is not cured within thirty (30) days of receipt of written notice from the injured party. Termination of one or more SOWs will not terminate this MSA.
1 Amplify delivers business value through a proprietary methodology and process.
2 Deliverables. Except as otherwise specifically agreed to in a SOW, Amplify will retain exclusive ownership in all Deliverables created by Amplify hereunder and will own all intellectual property rights, title and interest in any ideas, concepts, know how, documentation or techniques developed by Amplify under this MSA. Subject to payment in full for the applicable Services, Amplify grants Client a non-exclusive, non-transferable, royalty-free right to use the Deliverables solely in the country(ies) in which Client does business and solely for Client's internal use. "Deliverables" means the tangible and intangible materials, including reports, studies, base cases, drawings, findings, manuals, procedures and recommendations that are prepared by Amplify or its subcontractors in the course of performing the Services.
3 Tools & Software. Amplify will retain all intellectual property rights with respect to the processes, tools and software related to the Services. Any use by Client, including the execution, reverse engineering, decompilation, reproduction, modification, distribution, transmission, republication, display, transfer or performance, except as specifically permitted by Amplify during the term of Services is prohibited
1 It is the Client's responsibility to backup data on Client's system(s). Client acknowledges that Amplify's performance and delivery of the Services are contingent upon:
a Client providing safe and hazard-free access to its personnel, facilities, equipment, hardware, software, network and information for Services to be performed at Client's location, and
b Client's timely decision-making, notification of relevant issues or information and granting of approvals or permissions. Client will promptly obtain and provide to Amplify any required licenses, approvals or consents necessary for Amplify's performance of the Services.
1 In the performance of the Services, Client and Amplify may have access to or be exposed to information of the other party not generally known to the public, including, but not limited to software, product plans, marketing and sales information, Client lists, "know-how," or trade secrets which may be designated as being confidential or which, under the circumstances surrounding disclosure, ought to be treated as confidential (collectively, "Confidential Information"). Confidential Information may not be shared with third parties unless such disclosure is to personnel of Amplify or Client, including employees, agents and subcontractors, on a "need-to-know" basis in connection with its performance of this MSA, so long as such personnel have agreed to treat such Confidential Information under terms at least as restrictive as those herein. Each party agrees to take the necessary precautions to maintain the confidentiality of Confidential Information by using at least the same degree of care as such party employs with respect to its own Confidential Information of a like-kind nature, but in no case less than a commercially reasonable standard of care to maintain confidentiality, and shall only make such information available to its employees on a "need-to-know" basis. The foregoing shall not include information, which,
a was known by one party prior to its receipt from the other or is or becomes public knowledge without the fault of the recipient,
b is received by the recipient from a source other than a party to this MSA, or
c a party is required to disclose in response to an order by a court or governmental agency, provided that advance notice of the disclosure is provided to other party.
2 The obligations with respect to Confidential Information shall continue for three (3) years from the date of disclosure.
1 Limited Warranty. Amplify WARRANTS THAT SERVICES WILL BE PERFORMED IN A GOOD AND WORKMANLIKE MANNER.EXCEPT AS EXPRESSLY STATED IN THE PRECEDING SENTENCE, Amplify (INCLUDING ITS AFFILIATES, SUBCONTRACTORS AND AGENTS) AND EACH OF THEIR RESPECTIVE EMPLOYEES, DIRECTORS AND OFFICERS (COLLECTIVELY, THE "Amplify PARTY(IES)")MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO ANY OF THE SERVICES OR DELIVERABLES, INCLUDING BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, PERFORMANCE, SUITABILITY OR NON-INFRINGEMENT; ANY WARRANTY RELATING TO THIRD-PARTY PRODUCTS OR THIRD-PARTY SERVICES; ANY WARRANTY WITH RESPECT TO THE PERFORMANCE OF ANY HARDWARE OR SOFTWARE USED IN CONDUCTING SERVICES; OR ANY WARRANTY CONCERNING THE RESULTS TO BE OBTAINED FROM THE SERVICES OR THE RESULTS OF ANY RECOMMENDATION THE Amplify PARTIES MAY MAKE.
2 Limitation of Liability. NEITHER THE Amplify PARTIES NOR Client WILL BE LIABLE FOR ANY INCIDENTAL, INDIRECT, PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES, ARISING OUT OF OR IN CONNECTION WITH THE SERVICES PROVIDED BY Amplify. WHETHER DIRECT OR INDIRECT, NEITHER PARTY SHALL HAVE LIABILITY FOR THE FOLLOWING, (A) LOSS OF REVENUE, INCOME, PROFIT, OR SAVINGS, (B) LOST OR CORRUPTED DATA OR SOFTWARE, LOSS OF USE OF SYSTEM(S) OR NETWORK, OR THE RECOVERY OF SUCH, (C) LOSS OF BUSINESS OPPORTUNITY, (D) BUSINESS INTERRUPTION OR DOWNTIME, OR (E) SERVICES, Amplify PRODUCTS OR THIRD-PARTY PRODUCTS NOT BEING AVAILABLE FOR USE BY Client. THE Amplify PARTIES' AGGREGATE LIABILITY (WHETHER IN CONTRACT, TORT OR OTHERWISE) FOR ALL CLAIMS OF LIABILITY ARISING OUT OF, OR IN CONNECTION WITH ANY SERVICE PROVIDED PURSUANT TO THIS MSA SHALL NOT EXCEED THE AMOUNTS PAID BY Client FOR THE SPECIFIC SERVICE(S) GIVING RISE TO SUCH CLAIM DURING THE PRIOR TWELVE (12) MONTH PERIOD. EACH PARTY ACKNOWLEDGES THAT THESE LIMITATIONS APPLY EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR THE REMEDIES FAIL OF THEIR ESSENTIAL PURPOSE AND THAT, WITHOUT THESE LIMITATIONS, THE FEE FOR THE SERVICES PROVIDED HEREUNDER WOULD BE HIGHER.
1 Amplify shall defend, indemnify and hold harmless Client from any third-party claim or action that the Services or any Deliverables (excluding Third-Party Products) prepared or produced by Amplify and delivered pursuant to this Agreement infringe or misappropriate that third party's patent, copyright, trade secret, or other intellectual property rights enforceable in the country(ies) in which the Services or Deliverables are sold to Client by Amplify ("Indemnified Claims"). In addition, if Amplify receives notice of a claim that, in Amplify's reasonable opinion, is likely to result in an adverse ruling, then Amplify shall at its option, (A) obtain a right for Client to continue using such Service or Deliverable; (B) modify such Service or Deliverable to make it non-infringing; (C) replace such Service or Deliverable with a non-infringing equivalent; or (D) refund any prepaid fees for the allegedly infringing Services that have not been performed or provide a reasonable depreciated refund for the allegedly infringing Deliverable. Notwithstanding the foregoing, Amplify shall have no obligation under this Section for any claim resulting or arising from (A) Client's modifications of the Services or Deliverables that were not performed by or on behalf of Amplify; (B) the combination, operation or use of the Service or Deliverable in connection with a third-party product or service (the combination of which causes the infringement); or (C) Amplify's compliance with Client's written specifications or directions, including the incorporation of any software or other materials or process provided by or requested by Client.
2 Client shall defend, indemnify and hold Amplify harmless from, any third-party claim or action arising out of (A) the failure of Client to obtain the appropriate license, intellectual property rights, or any other permissions, regulatory certifications or approvals associated with Client provided technology, software or other components related to the Service, as well as software directed or requested by Client to be installed or integrated as part of Services, or (B) any inaccurate representations regarding the existence of an export license or any allegation made against Amplify due to Client's violation or alleged violation of applicable export laws, regulations, and orders.
3 Each party agrees to indemnify and hold harmless the other party from any third-party claim or action for personal bodily injuries, including death, resulting from the indemnifying party's gross negligence or willful misconduct resulting from the Services (excluding Third-Party Products) provided hereunder. This section states each party's exclusive remedies for any third-party claim or action, and nothing in this MSA or elsewhere will obligate either party to provide any greater indemnity to the other.
1 Independent Contractor Relationship; MSA Assignment; Subcontracting. The parties are independent contractors. Neither party will have any rights, power or authority to act or create an obligation, express or implied, on behalf of another party except as specified in this MSA. Amplify has the right to assign, subcontract or delegate in whole or in part this MSA, or any rights, duties, obligations or liabilities under this MSA, by operation of law or otherwise, provided that Amplify shall remain responsible for the performance of Services under this MSA. Otherwise, neither party may assign this MSA without the permission of the other.
2 Hiring of Amplify Consultants. Client agrees that the individual employed by or provided by Amplify to Client shall not be employed, retained, or hired as an employee, subcontractor or in any other capacity by Client. If during the term of this Agreement or for a period of 12 months after the expiration or cancellation of this agreement Client directly hires or retains an Amplify Consultant as an employee or independent contractor, the following conversion fee shall apply:
30% of annual base salary, invoiced on the start date and payable within 30 days.
3 Entire Agreement; Severability; Section Headings. This MSA and SOWs is the entire agreement between Amplify and Client with respect to its subject matter and supersedes all prior oral and written understandings, communications or agreements. No amendment to or modification of this MSA, in whole or in part, will be valid or binding unless it is in writing and executed by authorized representatives of both parties. If any provision of this MSA is void or unenforceable, the remainder of this MSA will remain in full force and effect. Section headings are for reference only and shall not affect the meaning or interpretation of this MSA.
4 Force Majeure. Neither party shall be liable to the other party for any failure to perform any of its obligations (except payment obligations) under this MSA during any period in which such performance is delayed by circumstances beyond its reasonable control including, but not limited to, fire, flood, earthquake, war, embargo, strike, riot or the intervention of any governmental authority (a "Force Majeure"). In such event, however, the delayed party must promptly provide the other party with written notice of the Force Majeure. The delayed party's time for performance will be excused for the duration of the Force Majeure, but if the Force Majeure events lasts longer than thirty (30) days, the other party may immediately terminate the applicable SOW by giving written notice to the delayed party.
5 Notices. Notice to Amplify under this MSA must be in writing and sent by postage prepaid first-class mail or receipted courier service to the address below or to such other address (incl. facsimile or electronic) as specified in writing and will be effective upon receipt.
Amplify Professional Services
Attn: Contracts Manager
22337 Pacific Coast Highway #488
Malibu, CA 90265
6 Governing Law, Forum and Language. THE PARTIES AGREE THAT THE MSA, ANY SALES THERE UNDER, OR ANY CLAIM, DISPUTE OR CONTROVERSY (WHETHER IN CONTRACT, TORT, OR OTHERWISE, WHETHER PREEXISTING, PRESENT OR FUTURE, AND INCLUDING STATUTORY, COMMON LAW, AND EQUITABLE CLAIMS) BETWEEN Client AND Amplify arising from or relating to the MSA, its interpretation, or the breach, termination or validity thereof, the relationships which result from this agreement or any related purchase SHALL BE GOVERNED BY THE LAWS OF THE STATE OF CALIFORNIA, WITHOUT REGARD TO CONFLICTS OF LAW. The parties agree that any and all claims, causes of action or disputes (regardless of theory) arising out of or relating to the MSA shall be brought exclusively in the courts located in Los Angeles County, California. Client and Amplify agree to submit to the personal jurisdiction of the courts located within Los Angeles County, California, and agree to waive any and all objections to the exercise of jurisdiction over the parties by such courts and to venue in such courts. This MSA will be interpreted and construed in accordance with the English language.
7 Dispute Resolution. Client and the Amplify Parties will attempt to resolve any claim, or dispute or controversy (whether in contract, tort or otherwise) arising out of or relating to this MSA, Amplify's advertising, or any related purchase (a "Dispute") through face-to-face negotiation with persons fully authorized to resolve the Dispute or through mediation utilizing a mutually agreeable mediator, rather than through litigation. The existence or results of any negotiation or mediation will be treated as confidential. Notwithstanding the foregoing, either party will have the right to obtain from a court of competent jurisdiction a temporary restraining order, preliminary injunction or other equitable relief to preserve the status quo, prevent irreparable harm, avoid the expiration of any applicable limitations period, or preserve a superior position with respect to other creditors, although the merits of the underlying Dispute will be resolved in accordance with this paragraph. In the event the parties are unable to resolve the Dispute within 30 days of notice of the Dispute to the other party, the parties shall be free to pursue all remedies available at law or equity.
8 Limitation Period. Neither party may institute any action in any form arising out of this MSA more than one (1) year (365 calendar days) after project completion per individual SOW.
9 Updates. Amplify reserves the right to update its MSA at any time, effective upon posting an updated version at www.Amplifyrt.com/MSA; however, Client's rights and obligations shall be as provided in the version of the MSA executed by Client or available to Client at the time of Client's purchase of Services or, when applicable, Client's renewal of Services.
10 Counterparts. If a signature block is appended hereto, this MSA may be executed in counterparts, each of which shall be deemed an original, but all such counterparts shall together constitute one and the same instrument.