Valve protector and system for preserving prosthetic valve integrity during implantation

Abstract

The present invention is integrated structures that protect a prosthetic heart valve, or portions thereof, from damage or degradation during the surgical implant procedure. Injury to the valve can come about by contact with sharp objects (needles, scissors, scalpel, etc.), suture entanglement or suture perforation at commissure tips, or tissue contact (in an exaggerated or aggravated manner). In the various embodiments described herein, the valve protector structures are specifically designed to engage the prosthetic valve to enable the surgeon to complete the implantation while minimizing the risk of compromising the structural or functional integrity of the prosthetic valve. The structure of the valve protector assembly is designed to engage with structurally more robust portions of the prosthetic valve, and to provide a combination of an upper portion on the lower portion that, together with the prosthetic valve, form an integrated assembly to protect the more delicate leaflet portions from damage during the implantation procedure.

Description

VALVE PROTECTOR AND SYSTEM FOR PRESERVING PROSTHETIC VALVE INTEGRITY DURING IMPLANTATIONBACKGROUND OF THE INVENTION

[0001] Heart valve disease is a significant cause of mortality among heart disease patients and the number of patients worldwide suffering from heart valve disease continues to increase. For some patients, replacement of a patient’s native valve with a prosthetic valve is the best surgical option. Hundreds of thousands of valve replacement procedures are performed annually and the state of technology of prosthetic valves has evolved and improved over several decades. The design and engineering of the prosthetic valve has become highly advanced as skilled engineers and physicians have progressively modified and improved the design. Given that these prosthetic valves are designed to last for the lifetime of the patient, the structures must be extremely robust and reliable given that the average human has about 35 million heartbeats per year and the valves are designed to last for decades. Prosthetic valves are designed with these demanding requirements in mind and prosthetic valves have enjoyed extraordinary success and have continued to evolve over many years. However, even with the best prosthetic valve technology the procedure for surgical replacement of a diseased or defective native valve is complex and requires considerable skill by the surgeon and relies on both the advanced engineering and design of the prosthetic valve together with application of complex surgical techniques to achieve a successful valve replacement outcome that lasts a lifetime.

[0002] Typically, prosthetic valves contain a structural support component made of a biocompatible metal or plastic, a portion of the prosthetic valve designed to engage or attach to the area surrounding the native valve (annulus) to secure the prosthetic valve in place, and a valve component having a series of leaflets, similar to the native valve. The leaflets are typically attached to structural supports at the “commissures,” the area where adjacent leaflets engage the structural support of the prosthetic valve, and open and close with each heartbeat in response to fluid pressures exerted by the contractions of thebeating heart that push blood through the valve such that the pressure exerted by the heart muscle can cause circulation of oxygenated blood throughout the body. Prosthetic valves are designed to provide the same functions as a native valve in a patient and also open and close in a repeatable fashion with each heartbeat just as with a native heart valve. The structure of modern prosthetic valves is both complex and extremely delicate and the design and tolerances involved in the engineering of the prosthetic valve are exacting and require tightly controlled manufacturing procedures as well as special instrumentation and a carefully controlled environment during the implantation procedure.

[0003] As will be readily appreciated, open-heart surgery can be difficult and traumatic and any number of circumstances can arise where the delicate structures of a prosthetic valve can be damaged or deformed during the implantation procedure. Moreover, this damage or deformation may not be readily recognized during the implant procedure. Damage to the prosthetic valve during surgical implantation can compromise the ability for long-term operability over potentially many, many years and can lead to poor function and increased the risk that a future, repeat valve replacement will be needed. Damage to a delicate prosthetic valve can also occur during sterilization or shipping. Also, to provide the same function as a native valve, the leaflets must be both thin, flexible, movable and capable of millions of cycles of opening and closing during the lifetime of an implant recipient. Therefore, special attention must be paid to preserving the structural and functional integrity of the leaflets of the prosthetic valve.

[0004] Additionally, the newest designs of prosthetic valves are increasingly manufactured from exotic materials including shape-memory, flexible metals, biocompatible fabric materials, advanced polymers and other delicate structures that can easily be damaged or have their structural integrity compromised during the surgical implant procedure. Accordingly, a need exists for a series of companion technologies that protect the prosthetic valve device during implantation and that improve the ability of the cardiac surgeon to both correctly size the prosthetic valve and to implant the valve without damage incurred during the surgical procedure.BRIEF SUMMARY OF THE INVENTION

[0005] The present invention is a series of medical devices having interrelated structural and design functions that all function to protect a prosthetic replacement valve device, or portions thereof, from damage or degradation, particularly during the surgical implant procedure. These devices act as companion devices that connect in various ways to protect the prosthetic valve to preserve structural and functional integrity of the prosthetic valve after implantation. These valve protector devices prevent bending or deformation of the prosthetic valve, and other forms of potential structural damage that can cause or negative impact on long-term function. In addition to mechanical damage to the structure of the prosthetic valve, prosthetic valve structural elements or portions of the components of the prosthetic valve such as the leaflets, damage can occur by contact with sharp objects (needles, scissors, scalpel, etc.), and suture entanglement or suture perforation at delicate portions of the prosthetic valve.

[0006] In the various designs described herein, described generally as “valve protectors,” the valve protector structures are specifically designed to engage with the prosthetic valve to provide a combination assembly that includes the prosthetic valve together with complementary features that provide structural support and protection of the prosthetic valve. In several configurations, the valve protector is structure and function are provided by the combination of an upper and lower portion. The upper portion is a rigid to semi rigid structure that provides structural support when attached to the outflow portion of a prosthetic valve and usually engages the circumference of a base of a stent frame of a prosthetic valve and has an open central passageway. The central passageway of the upper portion is designed so that a lower portion of the valve protector assembly can be passed through the upper portion and has a portion that extends into the internal volume of the prosthetic valve to provide the protector function. The lower portion may have a series of different configurations with the common objective of combining with the upper portion and the prosthetic valve to create an integrated and fixed combined assembly. Once assembled, the combined assembly, of the upper portion the lower portion and the prosthetic valve, enhances the ability of the cardiac surgeon to manipulate the entireassembly, typically by manipulating a handle integrated with the combined assembly to optimally orient the prosthetic valve at the native annulus, to complete the implantation while minimizing the risk of compromising the structural or functional integrity of the prosthetic valve. In many of the configurations described herein, the structure of the valve protector assembly is specifically designed to engage with structurally more robust portions of the prosthetic valve, such as structural support portions of a stent frame of the prosthetic valve supporting the commissures formed by the adjoining edges of leaflets of the prosthetic valve, or circumferentially around the annular base of the prosthetic valve, while protecting the more delicate leaflet portions from damage during preparation for, or performance of, the implantation procedure.

[0007] The labels applied to the series of different designs are arbitrary and are simply used as descriptors of various aspects of the upper and lower portion and are used to characterize and categorize different facets of the different designs and may refer to functional or structural features of the different designs to differentiate different structural and functional approaches to the common valve protection goal of all of the configurations.

[0008] . A “fin” embodiment has a single piece component having typically three fins that traverses the circumference of the valve base through a sewing ring and is oriented such that outer edges of each fin are coincident to each commissure such that the valve protector is positioned within the internal cavity of the valve in the space between the individual fins contain the delicate leaflets. The fin may extend distally to a length exceeding the axial length of the valve past the free edge of the leaflet to provide structural integrity of the internal surface of the valve. The distal most edge portions of the fin configuration may have a curved edge that extends laterally from a central support structure and engages the corresponding support structure on the prosthetic valve performed at each commissure. The curved edge avoids suture entanglement during the implantation procedure after which the fin configuration of the valve protector is removed.

[0009] The configurations of the valve protector an “obturator” configuration in both a retracted and deployed configuration. The obturator design, as the name suggests, blocksand occupies space within the valve orifice. The obturator design has two components that interact with each other to form two configurations: retracted and deployed. The outer component mounts directly to the valve sewing ring that is shaped as an annular cuff surrounding the valve base. The retracted configuration is for shipping and sterilization, where the inner component (obturator) does not make intimate contact with the leaflets. Upon deployment, the inner component is typically spaced away from the internal structure of the valve but may selectively make engaging contact selectively with a portion of an inner surface of the valve. A slight overhang of the obturator geometry protects the leaflet free edge during insertion. The domed (convex) surface on the “top” of the obturator keeps sutures from getting caught on the commissure tips during insertion.

[0010] An “umbrella,” “birdie” and “grommet” configuration are differing options for the most distal portion of the valve protector. As the name suggests, the “umbrella” configuration has a distal portion that can be both contracted and expanded at the discretion of the surgeon such that the most distal portion may flare outward to protect structures more proximal. The “birdie” configuration is similar to the umbrella configuration but has a shape memory metal configuration that is advanced distally through the native valve orifice and then deployed. The “grommet” configuration has an inner component comprised of a shape memory metal that may be formed to make a conical geometry to cover the valve during implantation and also has both a retracted and deployed configuration.

[0011] A “suture” configuration includes fibers that are looped through a sewing ring portion at the outflow annular portion of the prosthetic valve and is tensioned to facilitate attachment of the prosthetic valve to the native annulus.

[0012] In a “dual” configuration includes both of a first and second component that are mechanically coupled together to form a single unit and also paired with the prosthetic valve as part of the implantation procedure.

[0013] Each of an umbrella, a birdie, and a grommet configuration are comprised of shape memory materials affixed to the distal end of a shaft having a deployment mechanism that transforms each configuration from a contracted to an expandedconfiguration. Each design covers, but does not directly conform with the valve leaflets and as the distal end of the device forms either or both of the retracted and deployed configuration.

[0014] A “cover configuration” may be provided that adds a third component to the above configurations or may be provided as a single piece cover that is conforming the attachable to the distal end of the valve protector without any additional components of an assembly.

[0015] As will be described below, the combined assembly has a fixture for mechanical connection and attachment to a handle adapted to be held by the hand of the surgeon. Typically, the handle attachment fixture is provided on an external surface of the upper portion component and has a flexible shaft for allowing the surgeon to manipulate the positioning of the prosthetic valve during the implantation procedure.

[0016] While each of these configurations has different structures and characteristics, all provide the same function, i.e. to protect the prosthetic valve during any of sterilization, shipping, and during the implant procedure. Variations exist for the manner in which the structural portions of the valve protector, including both the upper portion and the lower portion, engage structural portions of the prosthetic valve and do so without departing from the spirit of the invention. In some embodiments, the combined valve and valve protector structure can be characterized by a proximal structural support portion engaging the base of the valve and circumferentially surrounding and engaging the base in such a manner that the structural support portion is positioned superior to the leaflet portion of the prosthetic valve. The lower portion typically traverses the structural support features of the upper portion and provides a structural and functional component disposed within an inner volume of the prosthetic valve upon integral assembly of the combination of the component parts of the valve protector. When integrated, the prosthetic valve may be positioned between the upper portion and the lower portion and fixed in position between the upper portion and the lower portion by several different mechanisms to form the integrated assembly. In some embodiments, the upper portion and the lower portion may be providedseparately from the prosthetic valve, or the combination may be preassembled and maintained in an expanded or confined configuration during sterilization and packaging. These and other possible variations will be apparent from the Detailed Description provided below together with reference to the accompanying Figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figures 1A through 1 E separate views of the fin embodiment showing different structural aspects of this configuration. Figure 1 A is an oblique view showing the proximal end of the fin configuration with the valve mounted therein a handle attachment point, and fin features extending into the prosthetic valve as structural supportl B is an oblique view showing the distal end of the fin configuration mounted within the prosthetic valve with the curved edge of each fin extending beyond the leaflet free edge valve to prevent suture entanglement and providing structural support to the valve when combined in the valve protector assembly. Figure 1 C is a top view of the proximal end of the upper portion of assembly, showing the handle receptor, the radial elements, and the sewing ring as an annular cuff circumferentially disposed within the diameter of the annular sewing ring is an annular suture array containing a plurality of suture passages or holes used to attach the valve protector to the sewing ring portion of the valve. Figure 1 D is a side view of assembly, showing the fin features extending beyond the free edge of the leaflet to prevent suture entanglement during implantation. Figure 1 E is a bottom view of the assembly

[0018] Fig. 2 shows the fin configuration attached to a handle manipulated by the surgeon to surgically deploy the valve in the appropriate anatomic annulus.

[0019] Fig. 3 is an isolated view of a version of the fin configuration having three fins equally spaced about the circumference of a lower portion of the assembly. The fins are aligned with the configuration of the upper portion having three radial elements extending away from a central column or and having suture grooves at the outermost radial edge thereof. A curved lower surface at the distal most edge of each fin is also shown. The upper portion also has a centrally oriented handle attachment fixture at a proximal end thereof.

[0020] Figure 4 is an exploded view of the fin configuration showing separate components including a structural support for the prosthetic valve and in annular cuff proximal to the

[0021] Fig. 5 is an exploded view of the dual configuration showing the structural support element, the meeting fixture and the prosthetic valve together with the handle to illustrate the assembly of all the component parts.

[0022] Fig. 6 A-F illustrate several configurations of the obturator configuration in both the retracted and expanded or deployed configuration.

[0023] Fig. 7 is views of the retracted obturator configuration together with the handle and may be described with and without the prosthetic valve disposed between the upper and lower portion of the integrated assembly.

[0024] Fig. 8 shows individual components of the obturator configuration showing how a lower portion traverses a central orifice in the upper portion having a circular structural support configuration. Support structure is an exploded view of the obturator configuration showing the individual components thereof.

[0025] Fig. 9 is a side-by-side comparison between the umbrella, birdie, and grommet embodiments of Figures 10-12 showing the distal end of the apparatus and cross-sectional dimensions of the distal end of the apparatus without the prosthetic valve.

[0026] Fig. 10 is a side-by-side comparison of three different versions of the umbrella configuration showing alternative configurations for the distal most structure at the end of the apparatus in various options for deployment from retracted to deployed configurations (without valve or handle).

[0027] Fig. 11 is a side-by-side comparison of three different versions of the birdie configuration showing alternate configurations for the distal most structure at the end of the apparatus in various options for deployment from retracted to deployed configurations (without valve or handle).

[0028] Fig. 12 is a side-by-side comparison of three different versions of the grommet configuration showing alternate configurations for the distal most structure at the end of the apparatus in various options from deployment from retracted to deployed configurations (without valve or handle).

[0029] Fig. 13 A-F are views of the suture configuration having the prosthetic valve mounted therein in various configurations. Figures 13A-E show the placement of sutures securing the prosthetic valve, the lower portion and the upper for portion having sutures engaging the lower portion traversing a sewing ring and facilitating attachment to the upper portion. Figure 13 F shows the upper structural portion and a portion of the integrated assembly that extends into the inner volume of the prosthetic valve upon assembly lower

[0030] Fig. 14 are an alternate design for the dual configuration showing attachment of the handle and an offset position.

[0031] Fig. 15 shows the integration of the structural support at the upper portion of the valve protector together with the cover described in Figure 15 and shows the alignment and attachment thereof. The valve (not shown) would be positioned intermediate to the upper support portion and the lower cover and aligned once assembled as in Figure 15.

[0032] Fig. 16 shows a structural support at the upper portion of the valve protector together with a cover as described in Figure 15 shown assembled to demonstrate the alignment and attachment thereof.

[0033] Fig. 17 shows a cover that fits over the integrated assembly comprising the upper portion, the lower portion, and optionally the valve and is affixed at the distal most portion thereof. The cover conformingly engages the curvature of the stent frame and has an overall extent beyond the distal most tips of the stent frame and free edge of the leaflets.

[0034] Fig. 18 shows the structural support at the upper portion of the valve protector together with the cover shown assembled to demonstrate the alignment and attachment thereof.DETAILED DESCRIPTION OF THE INVENTION

[0035] Leaflet protection is a factor in the design and packaging of all tri-leaf let heart valve types. Tissue heart valves typically use a surgical suture to cinch the tips of the commissure posts bringing them inward facilitating the implant procedure. The surgical suture is placed through the fabric covering the commissure post. If the prosthetic valve has no fabric covering the post making this approach is not viable and an alternate approach to leaflet protection must be implemented and any of the following designs may be adopted. The following description includes a valve protector assembly that has both an upper portion that provides structural support as described, and a lower portion that contains structures that are disposed within the inner volume of the prosthetic valve. These upper portion and lower portion components are separated and may be provided separately and combined with a prosthetic valve just prior to the implant procedure. Alternatively, the upper portion and lower portion may be integrally joined with a prosthetic valve such that the entire assembled unit is provided to the surgeon for use in the implant procedure. In either case, the integrated assembly is integrally formed and structurally intact and has an overall rigidity defined by the assembled structures. As noted, the function of the valve protector is to maintain the structural integrity of the prosthetic valve and so, in use, the valve is disposed at an intermediate portion between the structural supports of the upper portion and the operative elements of the lower portion to protect the valve. The options for orientation of the upper portion, had me structural supports, and the lower portion providing several functionalities will be apparent from the following description. In ordinary parlance, “proximal” refers to structures that are at the upper portion of the assembly and closer to the hand of the surgeon. “Distal” refers to structures most distant from the hand of the surgeon, and in these embodiments proximal is in the direction of the handle and distal is in the direction of the valve leaflets and the terminal end of the device that is farthest from the handle. Accordingly, the inflow orifice of the prosthetic valve is proximal to the leaflets and the leaflets are distal to the stent frame of the prosthetic valve and the sewing ring that is typically formed as an annular cuff circumferentially surrounds the inflow orifice of the prosthetic valve.

[0036] The first example described below is a tri-fin that extends upwards from the forward edge of the leaflets and prevents sutures from looping over the leaflet causing damage. Although three fins are described in the following embodiment, that number could be any range greater than two. The three fin embodiment for the tri-valve is preferred because the lateral edges of the fins align with a structural portion of the stent frame that is advantageous for structural strength of the upper portion and the lower portion containing the fins upon assembly with the prosthetic valve. This embodiment also may have a mechanical approach to prevent suture entanglement at the most distal end of the assembly comprising a curved distal edge is preferred to preclude suture entanglement because such damage to the leaflets within the body of the prosthetic valve, especially where that damage occurs during the later stages of the implant procedure, may be difficult to detect.

[0037] 1. Fin Configuration

[0038] The “fin” configuration valve protector has two primary functions: 1 ) the valve protector free edge of the valve by mounting proud of the leaflets. During the surgical procedure surgeons typically implant the prosthetic valve using a “parachute” technique where sutures are sewn into the myocardium at the native annulus, such as a mitral annulus, and then a large number of sutures are passed through the sewing ring while the valve is outside the chest cavity. This creates a configuration where sutures are passed through the tissue of the native annulus and then extend out of the surgical cavity and are looped through the sewing ring of the prosthetic valve to create a large number of connections between the native annulus and the prosthetic valve via sutures. The surgeon can then use the sutures to slide the valve into the surgical cavity to the native annulus or “drop” the valve into place by advancing the prosthetic valve along the length of all of the sutures by following the path created by sutures as they pass through the native annulus and through the sewing ring. As the prosthetic valve is advanced into the surgical cavity the valve “parachutes” into place at the target annulus, for example between the left atrium and left ventricle for a mitral valve.

[0039] During this time if the sutures are not kept taut they can be caught on the free edge of the leaflets or commissures of the valve. To avoid this, the valve protector mounts (by means of suture) such that the distal edge of the protector extends beyond the valve leaflets. In the version of the fin configuration below, a taper or curvature is provided at the distal edge of the valve protector such that any suture will easily slide off and over the prosthetic valve without coming into direct contact with the valve leaflets.

[0040] 2) The “fin” design provides structural support to the structure of the valve stent or frame. As noted above, metal or valve stent can bend or become deformed during the implant procedure. Similarly, even though advanced polymer structures such as when the valve frame or stent is formed from PEEK (polyetheretherketone), the material can still be affected by forces and stresses experienced during the implant procedure. Although PEEK is a strong material, it is still possible to deflect valve frame structures to degree that causes the material to transition from elastic deformation to plastic deformation. The structural support provided by the valve protector assembly prevents the PEEK from distorting or deforming. Additionally, reinforcement using the valve protector of the invention also facilitates improved insertion of the valve protector into the mitral annulus.

[0041] Referring to Figures 1A through E, 2 and 4, specifically figure 1A illustrates a perspective view the fin configuration of the valve protector that has a single piece component 10 that attaches to the base of the valve 11 At a sewing ring 12 formed as an annular cuff coincident to each valve commissure. As shown below, the fin 14 (not shown in FIG 1A) extends to a length exceeding the axial length of the valve past the free edge 15 of the leaflet 16. Together with the structural support component 9 the fins 14 provide structural integrity to the internal surface 17 of the valve 1 1 During surgical insertion and to avoid suture entanglement. Referring to Figures 1 , 2, 3, and 4, a single piece component 10 as assembled is comprised of the structural support member 9, the central post 22 that is preferably column shaped, radial elements 20 having grooves 20a formed at the most radial surface thereof that act as suture guides for attaching the sewing ring. The bottom distal edge of the fin embodiment 31 has an array of curved surfaces that extend outwardly and radially to prevent suture entanglement.

[0042] Referring to Figure 1 B a perspective view of the lower portion of the valve 11 shows the extension of the fins 14 projecting from a point distal of the sewing ring 12 and is positioned within the internal volume 17 of valve 11. The prosthetic valve 11 is both protected constrained by the structure of the fins 14 extending downward from the annular cuff sewing ring 12 and the structural support member 9. Each fin 14 extends within the internal volume 17 of the valve 11A sufficient length to exceed the axial length of the valve such that it may protrude past the free edge 15 of the leaflet 16. This provides structural stability to the internal surface of the stent frame 6 of the valve 11 During surgical insertion, and also has a curvature such that any suture or tissue will not be entangled or fixed to the valve 11 , and specifically the commissural tips of the valve 11. Referring again to Figure 1 B, the array of fins 14 are arranged to align with the valve frame 6 such that an outer edge of each fin 14 engages the valve frame 6 at the commissures 13. The fins 14 may be arranged to extend from a central core 30 connected to the structural support 9 to fix the position of the array of fins 14 and to provide structural rigidity to the entire assembly when combined fixed to the structural support member 9 to form single piece component assembly 10. Above, the distal or bottom portion of the array of fins 14 may have a curved outer surface 31 at the edge of each fin 14 to prevent suture entanglement at the inner volume 17 of the valve 11 when combined with the array of fins 14.

[0043] Referring to Figure 1 C, a top view of the fin configuration shows the annular cuff sewing ring 12 together with radial elements 20 arranged to align with the commissures 13 of the prosthetic valve 11 . Accordingly, in this configuration the radial elements 20 extend away from the handle receptor at the central post 22 and are each equally spaced apart by 120°. Each outermost portion of the radial element 20 has groove 20 a provides the guide by which the surgeon can place the suture and then cut the suture to remove the valve protector 1 once the valve 11 has been seated in the final, correct anatomical position. The frame flange 39 is circumferentially and positioned for continuous contact with the sewing ring number 12 when manufacturing the valve 11 to attach the sewing ring 12 with the valve frame for land 39 to provide that each suture passage 36 provides the ability for the surgeon to attach the valve 11 into the integrated assembly 10 . The radial elements 20 are continuous between the central post 24 extend beyond the frame flange at an outer orintermediate portion and terminate within the diameter of the annular sewing ring 12 to permit attachment of the valve 11 to the structural support member 9 and its component elements and structures. In the view of Figure 1 C, the upper portion is shown with handle receptor 26 centrally disposed within the central post 24 of the structural support member 9. Although this version of the upper portion is shown having three radial structural members 20, an option would be a full circumferential radial member, or a flange arrayed proximate to the sewing ring 12. Accordingly, while the structural support members of the upper portion are typically described together with radial support elements 20 it will be appreciated that other configurations for structural support are possible as long as the function of providing structural support is provided in that the feature or combination of features comprising the structural support member 9 is capable of fixed and releasable engagement with the proximal end of the prosthetic valve, preferably about a circumferential portion of the inflow orifice of the valve 11 .

[0044] Referring to Figure 1 D, a side view of the fin configuration shows the downward extensions of fins 14 beneath the annular cuff sewing ring 12 and arrayed around a central column 24 to provide structural rigidity to the assembly and to properly position the outer surface of the fins at the inner portion 17 of the valve and proximate to the valve frame 6. In this configuration, the central column 24 extends from the central post 22 to the distal end of the assembly to form the single piece component 10. In this example, the most distal edges of fins 14 have a curved surface 31 to prevent suture ensnarement. In the version shown in Figure 1 D the valve frame 6 inward curvature toward the central column axis 24 and the outermost edge of each fin 14 is contoured to engage the shape of the valve base 64 conforming engagement upon assembly

[0045] Referring to Figure 2, a handle 25 is affixed to the handle receptacle 26 at the central post 22 of the upper portion to allow manipulation of the single piece component 10 prosthetic valve 1 1 By the surgeon. The handle 25 may have a broader diameter portion 25a designed to be held by the hand, that also has a transitional portion 25b integrally connected with a smaller diameter lower portion 25c that is a more malleable portion so that the surgeon grasping the broader diameter proximal portion can bend the overallconfiguration of the handle 25 different anatomies and clinical situations. As in the embodiments of Figure 1A through E the integrated assembly, when connected to the handle 25 features the radial elements 20 and grooves 20a, 20b, 20c at the radial outermost portion of the element. Manipulation of the handle 25 applies force to the single piece integrated assembly 10 and the force is transferred through the central post 22 is transferred directly to the structural support member 9. The frame flange 39 is positioned circumferentially and inside the innermost portion of the sewing ring number 12 such that these inner and outer surfaces are engaged about the substantial portion of the annular configuration of the assembly when the valve 11 is part of the integrated assembly 10. The fin structures (not shown in figure 2) are positioned similarly as described above and located within the stent frame portion of the valve 6 in the inner volume 17 of the valve 11 . The frame flange 39 engages the inner periphery of the sewing ring 12 at the outer circumferential edge of the frame flange 39.

[0046] Referring to Figure 3, Fig. 3 is an isolated view of a version of the fin configuration were in the lower portion has three fins equally spaced about the circumference of a lower portion of the assembly. The fins are aligned with the configuration of the upper portion having three radial elements extending away from a central column or and having suture grooves at the outermost radial edge thereof. A curved lower surface at the distal most edge of each fin is also shown. The upper portion also has a centrally oriented handle attachment fixture at a proximal end thereof.

[0047] Referring to Figure 4, an exploded view of the fin configuration shows the handle 25 oriented for positioning the overall assembly / within the handle 25 engaging the handle receptacle 26 at the central post 22 of the single integrated assembly 10. Upon assembly, the single piece integrated assembly 10 is formed from the combination of the structural support member 9, the annular cuff sewing ring 12 and frame flange 39 to position the valve 11 proximate to the fins 14 within the inner volume 17 of the valve 11 to create the integrated assembly. The handle 25 meets with the handle receptacle 26 via a handle mating fixture 27 disposed between the handle 25 in the handle receptacle 26. The exploded view shows the separate structures of the handle 25 with the varying diameters,the manner of engagement of the handle at the handle mating fixture 27, the orientation of the radial element 20 the individual fins 14 and orientation with the valve 11 . This is a tri-fin design whereas described above, each fin 14 matches with a commissure of a tri-leaflet valve 11 .

[0048] 2. Dual Configuration-Figure 5

[0049] Referring to Figure 5, in the dual embodiment, two main components comprising an upper portion and a lower portion are mechanically coupled together. As in other designs described previously, the upper portion is attached to the base of the stent frame 6 at the sewing ring 12. The component includes the handle attachment feature 26 to attach the handle 25 as described previously, and a recessed area that may contain a coupling mechanism (e.g., magnet or threaded screw) by which the second component, or leaflet cover 116 is attached. The second component, or leaflet cover 116, is a rigid, sterilizable material that is shaped such that it can encompass the leaflets 16 of the valve 11 and avoid intimate contact. One or more external surfaces of the second component may also include a feature with a small annulus or eyelet - to be used for permanent or temporary attachment (e.g., lanyard) such that the second component 116 can be disconnected from the first without being difficult to retrieve in the operating field. In the configuration of Figure 5, the handle 25 is attached to the handle receptacle 26 via a socket head cap screw 127 that functions as a mating fixture between the distal end of the handle 25 and the proximal end of the structural support member 9. The exploded view of the dual component shows the combination of the valve 11 , the structural support member 9 and the second member 116 separated to illustrate the individual component parts and their assembly into the integrated unit. The external cover 116 is a single piece and contains threads in a blind hole within to which the radial elements mount by means of the mating fixture 127.

[0050] 3. Obturator (Figures 6 through 8)

[0051] Referring to figures 6A-F, 7, and 8, as the name suggests, the concept, structure, and function of an obturator applied in a different configuration, a different location and for a different purpose than prior obturators. As shown in these figures, the obturator occupiesspace within the interspace of the valve orifice 17. The obturator configuration is comprised of two components that cooperatively interact with each other to form two configurations: a retracted configuration and a deployed configuration. The outer component 8 mounts directly to the valve sewing ring 12. The retracted configuration is for shipping and sterilization, where the inner component of the obturator 26 does not make intimate contact with the optically clear leaflets 16. Upon deployment, the inner component 28 makes intimate contact with the inner surface of the leaflet free edge 15. A slight overhang of the obturator geometry 40 protects the leaflet free edge 15 during surgical insertion into the human body. The domed (convex) surface 47 on the “top” of the obturator keeps sutures from getting caught on the commissure tips during insertion with specific protrusions 46 that protect the valve commissures 13 of the leaflets 16.

[0052] An outer component mount 8, has a central through hole 55 within alignment feature, in this example a D-cross -shaped section 56. Two or more radial structural supports 20 that are attached to the sewing ring 12 of the valve 11 via one or more holes 43 at the end of each support where suture may be tied. And a notch 20a / b / c that enables the surgeon to cut the suture when disconnecting the mount 9 from the sewing ring 12 once the valve is in the correct anatomical position. As with the other embodiments described above the outer radial surface of each end of each radial structural support 20 has a cutaway feature 23 that corresponds with the inner diameter of the valve frame 17.

[0053] One or more axial cantilever members 42 of equal length and in this example corresponding with the orientation of the radial structural supports 20. The end of each cantilever member 42 has an inward protruding member that interacts with the shaft grooves 60a / 60b of the obturator to lock it into place in two axial configurations.

[0054] An inner component 28 of the obturator configuration has a central shaft 48 having a D-shaped cross-section 49 to prevent rotation and permit axial translation only when coupled with the outer component 9. A handle receptor 26 on the proximal end to allows connection of the handle 25. Two circumferential grooves 60a, 60b perform separate functions depending on the position of the obturator 44. Centrally disposed groove 60alocks the obturator in a “retracted” position; proximal groove 60b locks the obturator in the “deployed” position. The obturator configuration has a head 44 on the distal end of the shaft 48. A groove or “undercut” around the perimeter 40 of the head 44 where the free edge of the leaflets 15 rest and remain protected during surgical deployment. A convex distal surface 47 such that foreign material (tissue, sutures, etc.) will slide over and around the valve during surgical deployment. End protrusions are a committed serial feature 46 that provides protection to the valve commissures 13.

[0055] Referring to Figure 7, an assembled version of the obturator configuration in a retracted position shows the overall orientation similar to the fin configuration described above (see Figure 2) integrally connected to handle 25. The handle is integrally connected to the overall assembly and the handle receptacle 26 at the central post 22 to allow manipulation of the single piece component 10 prosthetic valve 11 By the surgeon. The handle 25 may have a broader diameter portion 25a designed to be held by the hand, that also has a transitional portion 25b integrally connected with a smaller diameter lower portion 25c that is a more malleable portion so that the surgeon grasping the broader diameter proximal portion can bend the overall configuration of the handle 25 different anatomies and clinical situations via a handle mating fixture 27 disposed between the handle 25 in the handle receptacle 26. The handle 25 is connected to the overall assembly 10 via a centrally disclosed column structure 48.

[0056] As in the above configurations, the assembly features sewing ring 12, frame flange 39, suture passages 36 disposed in the frame flange 39 and circumferentially oriented proximate to the sewing ring for attachment to the base of the valve 11. For the same purpose as described above, radial elements 20 are positioned at approximately 120° and coincide with the portion of the frame stent 6 of the valve and aligned with the commissures 13. Similarly, suture grooves 20a, b,c, are positioned at the outermost radial edge of the radial elements 20 and as shown in the series of Figure 6, the obturator 44 is positioned at the distal most portion of the assembly and functions as described above.

[0057] Referring to Figure 8, an exploded view of the obturator configuration shows the individual components thereof isolated from one another and prior to assembly into the one-piece overall assembly 10. As will be apparent from the foregoing description, the handle 25 is a separate piece, shown in Figure 8, having a handle mating fixture 27 at the distal most and for assembly, the handle passes through the inside of a separate structure harboring structural component 9 and radial elements 20 engage the handle receptacle 26. The column structure 48 contains the handle receptacle 26 and has the obturator 44 integrally attached at a distal end thereof. When integrated with the handle 25, a three- piece component is formed that has the proximal most portion of the handle 25, located at handle portion 25 adapted to be held by hand by the surgeon, and terminating at the distal end with the obturator 28. The intermediate piece is similar to the component piece described above with the three radial elements 20. Once these three component pieces are assembled, this subunit assembly is passed through the base of the valve 11 to position the obturator 44 near the distal most portion of the valve 11 . As described above, the radial units 20 are positioned to align with the commissures 13 formed at the stent frame 6 to provide structural support to the overall assembly once all component parts are integrally assembled. The holes 43 can be used to pass sutures that engage the sewing ring 12 to hold the integrated assembly in the desired position such that the radial elements 20 are aligned with the commissures 13 proximate to the stent frame 6 at the sewing ring 12.

[0058] Figure 9 is a side-by-side comparison of the Umbrella, Birdie, and Grommet configurations for comparison. The individual structural features of each configuration are described in Figures 10-12 below.

[0059] 7. Umbrella (Figure 10)

[0060] Referring to Figure 10, the umbrella-shape valve protector is comprised of a shapememory material that is designed to cover, but not directly conform with, the valve leaflets 15. The umbrella approach is comprised of two components that interact with each other to form two optional configurations: retracted and deployed. The outer component 80 mounts directly to the valve sewing ring 12 by means of radial structural members 20, althoughshown as three radial structural members 20, an option would be a full circumferential radial member, or flange arrayed proximate to the sewing ring 12. The retracted configuration is for shipping and sterilization, where the inner component umbrella 70 is contained within the inner bore 82 of the outer component 80. Upon deployment, the inner component 70 is advanced by means of a pusher 81 on the proximal end and a shapememory portion 71 on the distal end opens and forms back over the valve 11. Once the valve 11 is secured in the proper anatomic orientation, the inner component 70 is then retracted by pulling on the pusher 81 such that the umbrella 71 retreats into the inner bore 82 of the outer component 80, and the outer component 80 can be released from the valve 11 By cutting sutures that secure the radial structural members 20 to the sewing ring 12.

[0061] A cross-sectional portion is shown beneath each configuration in Figure 10 showing K-K, M-M, and J-J.

[0062] 8. Birdie (Figure 11 )

[0063] The configuration of Figure 11 is similar to the embodiment of Figure 10 and has similar functionality. A portion is comprised of a shape-memory material 73. The main difference between the configuration of Figure 10 and the configuration of Figure 11 , is that the outer component 80 must be advanced through the valve orifice past the leaflet free edge 15, then the inner component 70 is advanced by means of a pusher 81 through the bore 82, and the cover 73 deploys in a conical shape and is retracted slightly to cover the valve 11. To remove, the inner portion must be advanced slightly such that the “birdie” can be collapsed and retracted through the bore 82 of the outer component 80.

[0064] In this configuration, the radial structural member 20 in any of the potential design options 20 is not affixed to the outer component 80, but allows the outer component 80 to translate through.

[0065] A cross-sectional view of the device about axis A-A shows the internal structure and internal dimensions at this location for the configuration above the cross-section. Similarly, the cross-sectional view of the portion of the device about axis B-B shows the internalstructure and internal dimensions for the configuration above the cross-section. A cross- sectional view of the portion of the device about axis C-C shows the internal structure and internal dimensions for the configuration above the cross-section.

[0066] 9. Grommet (amplatz) (Figure 12)

[0067] Referring to the configuration of Figure 12, the design (labelled grommet / amplatz) references a design similar to a septal occluder. As above, an inner component 70 is comprised of a shape-memory material but can be formed to make a conical geometry 75 to cover the valve 11 During implantation. As with some other configurations described herein, the assembly is comprised of two components that interact with each other to form two configurations: retracted and deployed. The outer component 80 mounts directly to the valve sewing ring 12 by means of a flange or radial structural member(s) 20. The retracted configuration is for shipping and sterilization, where the inner component 70 is contained within the inner bore 82 of the outer component 80. Upon deployment, the inner component 70 is advanced by means of a pusher 81 Expand and form a protective cover 75 over the valve 11. Once the valve 11 is secured in the proper anatomic orientation, the inner component 70,75 is then retracted through the inner bore 82, and the outer component 80 can be released from the valve sewing ring 12.

[0068] Referring to the configuration of Figure 12, the configuration (labelled amplatz) reflects a design similar to a septal occluder. Again, an inner component 75 is comprised of a shape-memory material that may be formed to make a conical geometry to cover the valve 11 During implantation. As with some other configurations described herein, the assembly is comprised of two components that interact with each other to form two configurations: retracted and deployed. The outer component 76 is directly connected to the valve sewing ring 12. The retracted configuration is for shipping and sterilization, where the inner component (umbrella) 75 is contained within the inner bore 82 of the outer component 76. Upon deployment, the inner component 75 is advanced and opened to form a structure that backs over the valve 11 (see right panel). Once the valve 11 issecured in the proper anatomic orientation, the inner component 75 is then retracted, and the outer component 76 is released from the valve.

[0069] A cross-sectional view of the about axis F-F shows the internal structure and internal dimensions of the device immediately above the cross-section. A cross-sectional view of the portion of the device about axis G-G shows the internal structure and internal dimensions of the device immediately above the cross-section. A cross-sectional view of the portion of the device about axis H-H shows the internal structure and internal dimensions for the device immediately above the cross-section.

[0070] 10. Suture (Figure 13)

[0071] Referring to Figures 13A-13E, a suture configuration having the prosthetic valve 11 mounted therein has both an upper portion and a lower portion as described above for several configurations. The “suture” or “sutured” configurations includes fibers 85 such as sutures, or other soft fibers known to be biocompatible and non-damaging to the biocompatible materials used in the structure of the valve 11 , including designs where polymers are used to form the valve leaflets 16, that are looped through the sewing ring 12 portion of the valve 11 at the base of the stent frame 6 in locations coinciding with each commissure. Each loop 86 extends distally further than the commissure tip 87. A separate line of fiber 85a is connected to the end of each loop 86 and directed to the center bore 88 of a component 89 that is mounted to the prosthetic valve 11. The fibers 85 can then be put under a specific and fixed amount of tension to bend or cantilever the stent frame 6 and commissure tips 87 toward the center - in order to avoid impact with tissue or other obstruction during implantation. Upon proper anatomic orientation and fixation of the valve 11 , the tension on the separate line of fiber 85a can be released, and the remaining fibers 85 can be retracted entirely.

[0072] Referring to Figure 13A, a perspective view of the bottom surface of the suture embodiment of the valve protector of the invention shows the plurality of sutures 85 forming three discrete loops 86 that loop around a distal hook 90 at the distal most and then each constituent fiber 85, that is used form a single loop 86 traverses the sewing ring 12 at aposition aligned with the stent frame 6 and the commissures 13 of the valve 11. As described above, each loop 86 has a turn that is a distal to the commissure tips 87. After traversing the sewing ring 12 at three separate points, for a three-leaflet valve 11 , the suture fiber 85 may engage one or more of the groove(s) 20a, b,c, formed at the most radial point of the radial elements 20 as described above.

[0073] Referring to Figure 13B, a side view shows the orientation of the central column 22 having a central bore 88. As described above, the loops 86 of suture fibers 85 attached to a distal hook 90 and then traverse the sewing ring 12 to secure the position of the valve 11 in the combined assembly 10. As in the embodiment of Figure 13 A, the most distal portion of the loop engaging the distal hook 90 is also distal of the commissure points 87.

[0074] Referring to Figure 13C, a perspective view of the upper surface of the valve protector assembly is shown prior to the point at which any suture fibers 85 traverse the sewing ring 12 and shows the positioning of the combined assembly 10 with the radial elements 20 aligned with the portion of the stent frame 6 at the commissures 13. Accordingly, a method of practicing the invention includes orienting the valve such that the commissures 13 align with the radial elements 20 prior to attachment of the prosthetic valve 11 to the combined assembly 10 in preparation for manipulation of the suture fibers 85 to secure the valve 11 to the combined assembly 10.

[0075] Referring to Figure 13D, a rotated side view compared to the view shown in Figure 5B shows the orientation of the suture fibers 85 forming the loop 86 around the distal hook 90. The suture fibers 85, forming the loop 86 are positioned centrally to the stent frame 6 thereby aligning the loop with the grooves 20a, b,c when the suture fibers 85 traverse the sewing ring 12 as shown in Figure 13 D. Accordingly, the progression from Figure 13C to Figure 13D reflects confirmation of a proper alignment between the valve 11 and the superior structures comprising the radial elements 20 the central core 22 and the inferior elements comprising all the structures of the prosthetic valve 11 with particular attention given to the stent frame 6. Once this alignment is achieved, the prosthetic valve 11 is in a stable, secure, and properly oriented position for implantation.

[0076] Referring to Figure 13E, a top view of the suture configuration shows the individual suture fibers 85 form which the loop is formed traversing the sewing ring 12 and engaging the grooves 20a, b,c at the radial most portion of the radial elements 20. This view shows the central disposition of the handle receptacle 26 and the central bore 88 within the central post 22.

[0077] 7. Dual Configuration (Figure 14)

[0078] Referring to Figure 14, an oblique view of the dual configuration shows the structural support element the meeting fixture and the prosthetic valve assembled together with the handle to illustrate the assembly of all the component parts.

[0079] With respect to the DUAL configuration of Figure 14 the lower portion 116 comprise the most distal portion of the protector and encompass the valve leaflets 16. In this configuration proper alignment and orientation of the upper and lower portions is provided as in the configurations described above. When the integral assembly 10 is formed, the central column 144 does not disturb or distort the leaflet free edge 15. The upper portion 5, with structural support 9 is engaged with the orifice of the valve 11 until radial elements 20, 23 are in intimate contact with the valve 11 , potentially by engagement with the frame flange 39. In this configuration, the upper portion through hole 78 will be is axially aligned with lower portion hole 145. The fastener 127 is passed through hole 78 and engages with lower portion hole 145. The fastener 127 (SHCS) is rotated until upper portion 59 and lower portion 116 are fully engaged around valve 11. The upper portion 5 / 9 is attached to valve 11 by means of sutures, staples, or other releasable means. The handle 25 is offset from the through hole 78 and is proximate to a recessed area.

[0080] in the DUAL embodiment five and 14, an upper portion and a lower portion are mechanically coupled together with the upper portion attached to the base of the stent frame 6 at the sewing ring 12. The upper portion includes the handle attachment feature 26 to attach the handle 25 at a point offset and proximate to a recessed area with the coupling mechanism to attach the second component the second component, which is a rigid, sterilizable material that is shaped to surround the inner volume 17 of the valve 11 toencapsulate the leaflets 16 while avoiding intimate contact with the inner portion of the valve the handle 25 is attached to the handle receptacle 26 via a socket head cap screw 127 that functions as a mating fixture between the distal end of the handle 25 and the proximal end of the structural support member 9.

[0081] 8. Valve Protector Cover (Figures 15 and 16)

[0082] This embodiment of a mitral valve protector system is similar to what is shown in previous Figures 5 and 14.

[0083] Referring to Figures 15 and 17, a cover 116 fits over the integrated assembly 10 comprising the upper portion, the lower portion, and optionally the valve 11 and is affixed at the distal most portion thereof. The cover 116 conformingly engages the curvature of the stent frame 6 and has an overall extent beyond the distal most tips 6b of the stent frame and extending to the narrowest, most proximal extent of the base 6a of the stent frame 6 proximate to the sewing ring 12, and the most distal tips of the stent frame 6b. As described above, the valve frame 6 and the sewing ring 12 are structural elements of the prosthetic valve 11. In the configuration of Figure 15 incorporating the cover 16 structural features of the upper portion include the mount 5, the SHCS fastener in the cover 116.

[0084] The mount 5 has a central boss 126 with a counterbored hole 77 and a through-hole 78 such that the fastener 127 may pass through and seat in a receiving fixture. The counterbore 77 has snap-in features 79 along the counterbore internal diameter to retain the fastener 127 to prevent detachment. The mount 5 has an internal diameter to retain the fastener 127 to prevent detachment. The mount 5 has one or more radial structural elements 20, with possible alterations or options to strictly the radial structure as described above, and in this configuration the radial most extent of the radial elements 20 has two or more holes 140 and a channel 141 that may act as a suture groove to facilitate attachment of other structures to the mount 5. Specifically, the channel 141 or suture groove are used to secure the mount 5 to the sewing ring 12 using a biocompatible suture such as a polyester suture to fix the valve 11 to the upper portion until the sutures are severed. A pair of holes are used to secure the mount 5 to the valve sewing ring 12 by means of polyestersuture. The channel 141 is used by the surgeon to cut the polyester suture to remove the mount 5 from the valve 11 after the valve 11 has been seated in its appropriate anatomic position during the surgery. At a proximate to one of the radial structural elements 20 the handle 25 is attached to the upper portion at hole 142 in this configuration the handle receptor 26 is offset or eccentric axis of the valve 11 .

[0085] Continuing to refer to Figures 15 and 17, the cover 116 has three semi-elliptical surfaces 143 to cover and protect each of the three leaflets of the tri-leaflet valve (geometry is not a true ellipse, but matches the stent frame 6 geometry at the distal most portion). On the external surface of one of the semi-elliptical surfaces 143 is a cover flange 146 with two through holes. A lanyard or other suture (not shown) may be affixed to the cover 116 used to attach to the holes 147, for removal of cover during the implant procedure. The cover 116 also has a central boss 144 with support flanges that traverse the semi-closed valve, but do not come into intimate contact with the valve leaflets 16. At the center of the boss 144 is a blind threaded hole 145 to receive the fastener 127.

[0086] Referring to Figure 16, the structural support 9 at the upper portion of the valve protector together with the cover 116 (as described in Figure 15) are shown assembled to demonstrate the alignment and attachment thereof. The valve 11 (not shown) would be positioned intermediate to the upper structural support portion 9 and the cover 116 engaging a lower portion of the assembly and aligned with the upper portion once the upper and lower portions are assembled and secured as in Figure 15.

[0087] A method for use of the cover configuration in a mitral valve replacement surgery comprises removing the valve 11 from sterile packaging, the handle 25 is attached to the mount 5 at hole 142. Sutures (not shown are placed through the sewing ring 12 and the myocardium at the native annulus during the implant surgery. The cover 116 is removed by rotating, so as to unthread, the fastener 127. The fastener 127 remains seated in the valve due to radially inward protrusions 79 at the proximal end of counterbore 77. The lanyard (not shown) is manipulated to remove the cover 116 from the surgical field and the lanyard remains attached to the cover 116 via the holes 147. The sutures are held taughtand the valve is seated proximate to the myocardium between the left atrium and the left ventricle. Once the proper position is confirmed the surgeon severs the sutures at the holes 140 using the suture groove guide 141 to remove the mount 5 from the valve 11.

[0088] Referring to Figure 18, a single-piece protective cover 130 for an aortic valve encompasses the entire valve 11 , including the stent frame 6 in the leaflets 16 (not shown). The single piece protective cover 130 encompasses the outflow portion of the valve 11 During placement of a valve when the outflow is directed anatomically superior, such that the valve leaflet free edge 15 must be proximal to the handle for surgical deployment and insertion (e.g. aortic or pulmonic heart valve). The protective cover 130 has a known clearance between the cover 130 and the valve leaflets 16 when combined into an integrated assembly 10. The protective cover 130 is attached to the valve using through holes 133 connected by a suture to the sewing ring 12. An upper, topmost, or most proximate boss 131 comprises a threaded hole 132 to which a handle 25 may be connected for the surgical insertion.

[0089] The cover 130 has rigid surrounding surfaces 135 to cover and protect each of the three leaflets 16 of the tri-leaflet valve, and rigid surrounding surfaces 136 to cover and protect the stent frame 6 of the valve 11. Four or more through holes 133 secure the protective cover 130 cover to valve sewing ring 12. Sutures engaging the sewing ring 12 through the holes 133 are routed through and tied up at the eyelets and notches 134 for accessibility when removing the cover 130 after the valve 11 has been aligned anatomically and is prepared to be secured at the native annulus.

[0090] Accordingly, the invention includes a method of assembling a valve protector wherein a handle 25 traverses an open central axis of within a structural support structure 9 and comprising radially oriented suture grooves, affixing the handle 25 to a second component part containing a handle receptacle and having the obturator disposed at a distal end of this piece, once that three peace assembly is complete, the 3 piece assembly is passed into the valve 11 and positioned such that the valve 11 can be sewn to the other three components to form an integrated unit used to place the prosthetic valve 11 in asurgical environment by manipulation of the handle 25 and wherein the obturator portion is located at a distal most and thereof. The method step includes aligning a component of the first assembly with the body of the valve stent frame to align the commissures therewith.

[0091] Initiated by one of skill in the art, the following method steps set forth for a particular configuration can readily be applied to a different configuration when necessary and the individual steps are combined with the following steps that are specific for different configurations. For example, with respect to the fin configuration of the valve protector a lower portion containing the fin array as described in Figure 3 is inserted into the inner volume of the valve 17 and slowly advanced to align fins 14 with the commissures 13 until the radial elements 20 / 23 are in intimate contact with the valve 11 such as at frame flange 39. The integrated assembly 10 is facilitated by attachment of the valve 11 to the upper and lower portions through the use of means for attachment comprising sutures, staples, or other releasable mechanisms.

[0092] In this method, a suture 85 is passed through the grooves 20a, 20b, 20c at the most radial extent holes at the end of radial element 20 and into the valve sewing ring 12, and looped at the distal surface of the sewing ring 12 and back through the adjacent hole at the end of radial element 20. Suture ends are tied together on the proximal side of radial element 20 above the groove 20a. These steps are repeated for each radial element, alternatively the suture is continually passed through the grooves 20a, 20b, 20c at the end of each radial element 20 until the suture 85 has been passed through all radial elements 20 around the full or partial circumference of the valve.

[0093] With respect to the DUAL or cover configurations of Figures 5, 14, and 15-17, the lower portion comprising the cover 116 is placed at the most distal portion of the protector and over the valve leaflets 16. Alignment and orientation of the leaflet covers 135, and 143 with the leaflets 15 and the stent frame 6 is insured and confirmed. An inspection of the integrated assembly 10 ensures that the central column 144 does not disturb or distort the leaflet free edge 15. The upper portion 5, with structural support 9 is engaged with the orifice of the valve until radial elements 20, 23 are in intimate contact with the valve 11 ,potentially by engagement with the frame flange 39. In this configuration, the upper portion through hole 78 will be is axially aligned with lower portion hole 145. The fastener 127 is passed through hole 78 and engages with lower portion hole 145. The fastener 127 (SHCS) is rotated until upper portion 59 and lower portion 116 are fully engaged around valve 11 . The upper portion 5 / 9 is attached to valve 11 by means of sutures, staples, or other releasable means.

[0094] With respect to the obturator configuration of Figures 6-8, an upper portion 8 and lower portion 28 are engaged with one another in the deployed position by passing lower portion shaft 48 through upper portion hole 55 until upper portion cantilever members 42 engage with lower portion circumferential groove 60b. The combined upper and lower portions 8,28 are inserted through the valve orifice to be disposed with the interior volume of the valve 17 by slowly advanced the lower portion through the orifice and ensuring that the obturator perimeter and commissural features 46 are aligned with leaflet free edge 15 and valve commissures 13 until radial elements 20, 23 are in intimate contact with the valve 11 proximate to the frame flange 39. The upper portion 5 with structural support 9 is attached to valve 11 by means of sutures, staples, or other releasable means

[0095] The lower portion 28 may be moved to a retracted position by translating lower portion shaft 48 through upper portion hole 55 until upper portion cantilever members 42 engage with lower portion circumferential groove 60a.

[0096] With respect to the suture configuration of Figure 13A-F, component 89 is inserted into valve orifice 17 and slowly advanced to align distal hooks 90 with commissures 13 - until radial elements 20 are in intimate contact with the valve 11 13 proximate to the frame flange 39. Component 89 is attached to valve 11 by means of sutures, staples, or other releasable means. Suture fibers 85,86 are looped through distal hooks 90 and the suture fibers 85,86d are attached to the valve 11 by passing through sewing ring 12. The suture fibers can also be passed through holes at the end of radial members 20 in place of sutures instead of the step described above where separate sutures are used. The stent frame 6 of the valve 11 may be manually bent inward toward component 89 and fiber 85 is tightenedand secured to maintain the stent frame 6 frame within structural elastic parameters for elastic deformation of the integrated assembly 10.

[0097] V. With respect to the umbrella, birdie, and grommet configurations of Figures 9-12, and upper portion 76, 80 is inserted into valve orifice 17 and slowly advanced to align distal hooks 90 with commissures 13 - until radial elements 20 are in intimate contact with the valve 11 proximate to the frame flange 39. The upper portion 76 / 80 is attached to valve 11 by means of sutures, staples, or other releasable means. The shape memory element 71 , 73, 75 of the lower portion 70 is deformed to fit within central bore 82 of upper portion 76, 80.. The lower portion 70 is advanced within central bore 82 of upper portion 76,80 to a position such that shape memory element 71 ,73,75 does not fully protrude from distal end of upper portion bore 82.

[0098] With respect to be aortic cover of figure 18, [to be inserted],

[0099] The invention includes a an upper structural support having ( a rigid component) oriented to engage a circumferential orifice of the prosthetic cardiac valve upon assembly with a lower portion (and means to attach a handle); a lower portion shaped to traverse the orifice of the prosthetic valve upon assembly therewith and having one or more structures disposed within an internal volume of the prosthetic valve upon assembly with the upper structural support and configured to be fixed in position proximate to the leaflets of the prosthetic valve (and not in contact with the leaflets) upon assembly; and wherein the upper structural support has means to attach the prosthetic valve to form an assembly of the upper portion, the lower portion and the prosthetic valve upon assembly.

[0100] The invention also includes a prosthetic valve fixed to the upper structural support, attached by the means for attaching the prosthetic valve to the upper portion, the lower portion disposed within an internal volume of the prosthetic valve and wherein, the prosthetic valve is comprised of a plurality of leaflets disposed within the internal volume capable of moving between an open and a coapted configuration in response to changes in fluid pressure exerted by the beating heart.

[0101] The invention includes a valve protector, wherein the lower portion is comprised of an array of fin elements arranged in a fixed to a central axis and extending laterally such that the lateral portion of the fin is spaced away from the inner surface of the prosthetic valve. The invention also includes a valve protector, wherein a distal portion of at least one fin of the fin array is comprised of a curved distal edge extending distally beyond a free edge of any of the plurality of leaflets. In one configuration at least one fin element of the fin array is aligned with a commissure of the prosthetic valve formed at a structural portion of the stent frame of the prosthetic valve located at the joining edge of adjacent leaflets.

[0102] The invention includes a configuration where an upper structural support is comprised of a radial support structure extending radially from a central column and that is aligned with the at least one fin element of the fin array the radial support structure may have a fixture at a most radial portion thereof for attachment of a suture that traverses a sewing ring of the prosthetic valve. In some configurations, a lower portion is comprised of an obturator having at least two configurations: a first configuration where the obturator is contained entirely within the inner volume of the prosthetic valve and a second configuration wherein the obturator extends to distally beyond a distal most edge of the valve leaflets.

[0103] In some configurations and obturator is used that is comprised of two components that cooperatively interact with each other to form both a retracted configuration and a deployed configuration wherein an outer component mounts directly to the sewing ring of the prosthetic valve. An inner component the obturator may not make intimate contact with the leaflets in the retracted configuration, alternatively, the inner component may make intimate contact with inner surface of a free edge of a leaflet of the prosthetic valve and the obturator may be comprised of a convex, domed surface at a proximal end thereof.

[0104] In some configurations, and outer component of the valve protector has a mount having a central through hole with an alignment feature to prevent rotation of a lower portion relative to an upper portion. An upper section of the valve protector may have twoor more radial structural support structures having two or more holes at the radial extent of each support structure and a groove designed to receive a suture and may include one or more axial cantilever members of substantially equal length and having an inward protruding member inoperable connection with either of two circumferential shaft grooves such that a centrally disposed groove locks the obturator in a retracted position or in a deployed position.

[0105] The valve protector may have an upper portion and a lower portion configured to be mechanically coupled together, wherein an upper portion is attached to a base of a stent frame proximate to a sewing ring 12 and further comprising a handle attachment feature 26 wherein the second component is formed from a rigid, sterilizable material that shaped to encompass leaflets of the valve without intimate contact therewith. The upper portion is further comprised of a recessed containing a coupling by which either of a second component or a leaflet cover where the coupling mechanism is a magnet or a threaded screw. One or more of external surfaces of the second component may include includes a small annulus or eyelet for reversible attachment of the second component from the first component or where a handle is attached to the handle receptacle a by a socket head cap screw is a mating fixture between the distal end of the handle and proximal end of a the structural support member in the upper portion. In any of the foregoing configurations, the valve protector may also have a cover capable of attachment to the distal most and of the valve protector at the outflow portion of the prosthetic valve, wherein the cover is in conforming engagement with the curvature of the stent frame of the prosthetic valve. The cover may have a fixture capable of attachment to a longitudinal element that traverses a central bore of the upper portion and reversibly connects the cover to the upper portion. In any of these configurations, the lower portion and the upper portion are connected by means for attachment of the upper portion and the lower portion that passes through the sewing ring of the prosthetic valve that may be a suture that traverses the selling ring to attach to a portion of the upper structural support that is comprised of two or more radial elements extending from a central post and having a suture guide a radial extent thereof.

[0106] The invention also includes a valve protector assembly comprising only a prosthetic valve and a cover, wherein the cover is shaped to conform to the curvature of the distal most end of the valve protector at the outflow portion of the prosthetic valve along the curve of attachment between the leaflets and the stent frame of the prosthetic valve, wherein the cover is in conforming and removable engagement with prosthetic valve and comprises a fixture for selective removal of the cover.

[0107] The invention includes methods to assemble a valve protector including:

[0108] -providing an upper structural support conformed to engage to a prosthetic valve, wherein the upper structural support has an orifice aligned with an internal volume of a prosthetic valve;

[0109] -positioning a prosthetic valve in conforming engagement with the upper structural support, wherein the prosthetic valve has an internal volume comprising leaflets attached to a stent frame;

[0110] -traversing the orifice of the upper structural portion with a lower portion to dispose one or more structures within the internal volume of the prosthetic valve;

[0111] -releasably securing the combination of the upper structural support, the prosthetic valve, and the lower portion to form an integral assembly.

[0112] -releasably securing the combination is comprised of connecting the lower portion to the upper structural support by means for attaching the upper structural support, the lower portion, and the prosthetic valve.

[0113] - inserting a lower portion containing the fin array into the inner volume of the valve and advancing the lower portion to engage advanced to align the fins the commissures and engage the upper portion at frame flange.

[0114] - passing a suture through the grooves of a radial element and manipulating the suture to attach the valve to the sewing ring.

[0115] -tying suture ends together on the proximal side of radial element.

[0116] -placing a cover at the most distal end of the valve protector to cover the valve leaflets.

[0117] - orienting one or more leaflet covers with the valve leaflets.

[0118] -aligning distal hooks of view lower portion with the commissures until the radial elements are in contact with the valve 11 and in contact with the frame flange.

[0119] -passing suture fibers through holes at a portion of the radial members.

[0120] - manually bending a frame stent inward using one or more fibers tightened to maintain the configuration of the stent frame

[0121] -advancing the distal end up of an apparatus comprising a shape memory metal and advancing the apparatus to align distal hooks with the valve commissures until the radial elements are in intimate contact with the valve proximate to the frame flange;

[0122] -deforming the shape memory metal of a lower portion to be deformed to fit within a central bore of an upper portion.

[0123] -advancing the shape memory element to a position that does not protrude from the upper portion.

[0124] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions,and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.

[0125] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.

[0126] Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims.

Claims

CLAIMSWe Claim:1 . A valve protector for a prosthetic valve comprising: an upper structural support having oriented to engage a circumferential orifice of the prosthetic cardiac valve upon assembly with a lower portion and means to attach a handle; lower portion shaped to traverse the orifice of the prosthetic valve upon assembly therewith and having one or more structures disposed within an internal volume of the prosthetic valve upon assembly with the upper structural support and configured to be fixed in position proximate to the leaflets of the prosthetic valve assembly; and wherein the upper structural support has means to attach the prosthetic valve to form an assembly of the upper portion, the lower portion and the prosthetic valve upon assembly.

2. The valve protector of claim 1 , further comprising the prosthetic valve fixed to the upper structural support, attached by the means for attaching the prosthetic valve to the upper portion, the lower portion disposed within an internal volume of the prosthetic valve and wherein, the prosthetic valve is comprised of a plurality of leaflets disposed within the internal volume capable of moving between an open and a coapted configuration in response to changes in fluid pressure exerted by the beating heart.

3. The valve protector of claim 2, wherein the lower portion is comprised of an array of fin elements arranged in a fixed to a central axis and extending laterally such that the lateral portion of the fin is spaced away from the inner surface of the prosthetic valve.

4. The valve protector of claim 3, wherein a distal portion of at least one fin of the fin array is comprised of a curved distal edge extending distally beyond a free edge of any of the plurality of leaflets.

5. The valve protector of claim 2, wherein at least one fin element of the fin array is aligned with a commissure of the prosthetic valve formed at a structural portion of the stent frame of the prosthetic valve located at the joining edge of adjacent leaflets.

6. The valve protector of claim 5, wherein the upper structural support is comprised of a radial support structure extending radially from a central column and that is aligned with the at least one fin element of the fin array.

7. The valve protector of claim 6, wherein the radial support structure has a fixture at a most radial portion thereof for attachment of a suture that traverses a sewing ring of the prosthetic valve8. The valve protector of claim 1 , wherein the lower portion is comprised of an obturator having at least two configurations: a first configuration where the obturator is contained entirely within the inner volume of the prosthetic valve and a second configuration wherein the obturator extends to distally beyond a distal most edge of the valve leaflets.

9. The valve protector of claim 1 , wherein the obturator is comprised of two components that cooperatively interact with each other to form both a retracted configuration and a deployed configuration.

10. The valve protector of claim 8, wherein an outer component mounts directly to the sewing ring of the prosthetic valve.

11. The valve protector of claim 9, wherein an inner component of the obturator does not make intimate contact with the leaflets in the retracted configuration12. The valve protector of claim 9, wherein the inner component makes intimate contact with inner surface of a free edge of a leaflet of the prosthetic valve13. The valve protector of claim 8, wherein the obturator is comprised of a convex, domed surface at a proximal end thereof.

14. The valve protector of claim 10, wherein the outer component is comprised of a mount having a central through hole with an alignment feature.

15. The valve protector of claim 1 , wherein the alignment feature has an alignment feature to prevent rotation of the lower portion relative to the upper portion.

16. The valve protector of claim 1 or 8, wherein the upper section is comprised of two or more radial structural support structures having two or more holes at the radial extent of each support structure and a groove designed to receive a suture.

17. The valve protector of claim 8, comprising one or more axial cantilever members of substantially equal length and having an inward protruding member inoperable connection with either of two circumferential shaft grooves.

18. The valve protector of claim 17, wherein a centrally disposed groove locks the obturator in a retracted position.

19. The valve protector of claim 17, wherein a proximal groove locks the obturator in the a deployed position.

20. A valve protector comprising: an upper portion and a lower portion configured to be mechanically coupled together, wherein upper portion is attached to a base of a stent frame proximate to a sewing ring and further comprising a handle attachment feature and a recessed area; and a lower portion comprising second component or a leaflet cover wherein the second component is formed from a rigid, sterilizable material that shaped to encompass leaflets of the valve without intimate contact therewith.

21. The valve protector of claim 20, wherein the upper portion is further comprised of a recessed containing a coupling by which either of a second component or a leaflet cover22. The valve protector of claim 21 , wherein the coupling mechanism is a magnet or a threaded screw.

23. The valve protector of claim 20, wherein one or more of external surfaces of the second component includes a small annulus or eyelet for reversible attachment of the second component from the first component24. The valve protector of claim 20, wherein a handle is attached to the handle receptacle a by a socket head cap screw.

25. The valve protector of claim 24, wherein the socket head cap screw is a mating fixture between the distal end of the handle and proximal end of the structural support member in the upper portion.

26. The valve protector of claims 2-25, further comprising a cover capable of attachment to the distal most and of the valve protector at the outflow portion of the prosthetic valve, wherein the cover is in conforming engagement with the curvature of the stent frame of the prosthetic valve.

27. The valve protector claim 26, wherein the cover has a fixture capable of attachment to a longitudinal element that traverses a central bore of the upper portion and reversibly connects the cover to the upper portion.

28. The valve protector of claims 2-27 wherein the lower portion and the upper portion are connected by means for attachment of the upper portion and the lower portion that passes through the sewing ring of the prosthetic valve.

29. The valve protector of claims 2-28, wherein the attachment means is a suture that traverses the sewing ring and attaches to a portion of the upper structural support30. The valve protector of claims 2-29, wherein the upper structural support is comprised of two or more radial elements extending from the central post and having a suture guide at a most radial extent thereof.

31. The valve protector of claims 2-29, wherein the two or more radial elements are three radial elements that extend from the central post and aligned with the commissures formed by the structure of the stent frame of the prosthetic valve.32 The valve protector of claims 2-29 wherein the lower portion is comprised of a notch.

33. A valve protector assembly comprising a prosthetic valve and a cover, wherein the cover is shaped to conform to the curvature of the distal most end of the valve protector at the outflow portion of the prosthetic valve along the curve of attachment between the leaflets and the stent frame of the prosthetic valve, wherein the cover is in conforming and removable engagement with prosthetic valve and comprises a fixture for selective removal of the cover.

34. The valve protector of claim 33, further comprising a fixture for selective removal of the cover.

35. The valve protector of claim 34, wherein the fixture for selective removal of the cover is a lanyard.

36. The valve protector of claim 34, wherein the prosthetic valve and the cover are coupled together in a sterilized package.

37. The valve protector of claim 33, comprising at least one semi-elliptical surface.

38. A method to assemble a valve protector comprising; providing an upper structural support conformed to engage to a prosthetic valve, wherein the upper structural support has an orifice aligned with an internal volume of a prosthetic valve; positioning a prosthetic valve in conforming engagement with the upper structural support, wherein the prosthetic valve has an internal volume comprising leaflets attached to a stent frame;traversing the orifice of the upper structural portion with a lower portion to dispose one or more structures within the internal volume of the prosthetic valve; releasably securing the combination of the upper structural support, the prosthetic valve, and the lower portion to form an integral assembly.

39. The method of claim 38, wherein the step of releasably securing the combination is comprised of connecting the lower portion to the upper structural support by means for attaching the upper structural support, the lower portion, and the prosthetic valve.

40. The method of claim 39, wherein the attachment means is a suture that traverses the sewing ring and engages a portion of the upper structural support.

41. The method of claim 38, wherein the lower portion containing the fin array is inserted into the inner volume of the valve and advanced to align the fins the commissures and engage the upper portion at frame flange 39.

42. The method of claim 38, wherein a suture is passed through the grooves of the radial element and manipulated to so the valve to the sewing ring.

43. The method of claim 42, wherein the suture ends are tied together on the proximal side of radial element above one or more of the. These steps are repeated for each radial element, alternatively the suture is continually passed through the grooves 20a, 20b, 20c at the end of each radial element 20 until the suture 85 has been passed through all radial elements 20 around the full or partial circumference of the valve.

43. The method of claims 38-43 further comprising placing a cover at the most distal end of the valve protector to cover the valve leaflets.

44. The method of claims 38-43 further comprising orienting one or more leaflet covers with the valve leaflets.

45. The method of claim 38, wherein an integrated assembly is created by engaging an upper portion with a structural support with an orifice of the valve until the radial elements are in contact with the valve 1146. The method of claim 38, wherein distal hooks of view lower portion are aligned with the commissures until the radial elements are in contact with the valve 11 and in contact with the frame flange.

47. The method of claim 46, wherein suture fibers are passed through holes at a portion of the radial members.

48. The method of claims 38-47, wherein the stent frame is manually bent inward and one or more fibers is tightened to maintain the configuration of the stent frame.

49. A method to assemble a valve protector comprising: advancing the distal end up of an apparatus comprising a shape memory metal and advancing the apparatus to align distal hooks with the valve commissures until the radial elements are in intimate contact with the valve proximate to the frame flange; and, deforming the shape memory metal of a lower portion to be deformed to fit within a central bore of an upper portion and advancing the shape memory element to a position that does not protrude from the upper portion

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