Information marker for cardiac prosthesis and method of use thereof

Abstract

To provide a method of implanting a replacement prosthetic heart valve in an original heart prosthesis in one aspect.SOLUTION: A heart prosthesis includes at least one information marker and a method of using the heart prosthesis are disclosed. The at least one information marker may indicate any suitable information such as one or two or more out of a manufacturer, a type, a model, a feature, a size, and a date associated with the heart prosthesis. The heart prosthesis may include any suitable prosthesis such as a prosthetic heart valve, an annuloplasty prosthesis.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 61 / 904,565, filed November 15, 2013, entitled "INFORMATION MARKERS FOR HEART PROSTHESES AND METHODS OF USING SAME," which is incorporated herein by reference in its entirety. [Background technology]

[0002] Heart valves that are defective due to disease or other reasons can be repaired or replaced using a variety of different types of heart valve surgery. Typical heart valve surgery involves open-heart surgery performed under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung machine. This type of valve surgery is highly invasive and exposes patients to numerous serious risks, such as infection, stroke, kidney failure, and side effects associated with the use of a heart-lung machine.

[0003] Recently, there has been growing interest in minimally invasive percutaneous replacement of native cardiac prostheses, such as prosthetic heart valves and valvuloplasty prostheses. In these surgical techniques, a very small opening is made in the patient's skin, through which a valve assembly is inserted and delivered to the heart via a catheter-like delivery device. This technique is often preferred over more invasive forms, such as the open-heart surgery methods mentioned above. In the context of pulmonary valve replacement, U.S. Patent Nos. 5,629,996 and 5,729,996, both filed by Tower et al., describe the mounting of a valved portion of a bovine jugular vein within an expandable stent for use as a replacement pulmonary valve. This replacement valve is mounted on a balloon catheter and delivered percutaneously through the vasculature to the location of the failed pulmonary valve. It is then expanded by the balloon, compressing the valve leaflets against the right ventricular outflow tract and creating a fixed seal. As described in Non-Patent Documents 5 and 6, replacement pulmonary valves can be implanted to replace either the native pulmonary valve or a prosthetic pulmonary valve located within a valved conduit.

[0004] In valve surgery, prosthetic heart valves of various types and configurations are used to replace diseased native human heart valves. The actual shape and configuration of any particular prosthetic heart valve depends, to some extent, on the valve it is replacing (i.e., mitral, tricuspid, aortic, or pulmonary). Generally, prosthetic heart valve designs attempt to replicate the function of the valve they are replacing and therefore include leaflet-like structures for use with either bioprosthetic or mechanical heart valve prostheses.

[0005] A percutaneously delivered replacement valve may include a valved vessel segment somehow mounted within an expandable stent to form a stent-valve. To prepare such a percutaneously implanted valve, the stent-valve is first prepared in an expanded or uncollapsed state and then collapsed or compressed around the balloon portion of a catheter to as close to the diameter of the catheter as possible.

[0006] Other percutaneously delivered prosthetic heart valves with generally similar configurations have been proposed, such as in Non-Patent Documents 2 and 3, which are incorporated herein by reference. These techniques rely at least in part on friction-type engagement between an expanded support structure and native tissue to maintain the position of the delivered prosthesis, but can also allow the stent to be at least partially implanted into the surrounding tissue in response to radial forces exerted by the stent and a balloon that may be used to expand the stent. Thus, these transcatheter techniques do not require the prosthetic heart valve to be sewn into the patient's native tissue as in the past.

[0007] Similarly, the percutaneous delivery of a tissue valve is described in "Percutaneous Delivery of a Bioprosthetic Valve," vol. 1, No. 1, pp. 111-114, the disclosure of which is incorporated herein by reference. The valve is sutured to a previously implanted valved or unvalved conduit or to an expanding stent within a previously implanted valve. Again, radial expansion of the secondary valve stent is used to deploy and maintain the replacement valve. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] US Patent Application Publication No. 2003 / 0199971 [Patent Document 2] US Patent Application Publication No. 2003 / 0199963 [Patent Document 3] U.S. Patent No. 3,671,979 [Patent Document 4] U.S. Patent No. 4,056,854 [Patent Document 5] U.S. Patent No. 4,994,077 [Patent Document 6] U.S. Patent No. 5,332,402 [Patent Document 7] U.S. Patent No. 5,370,685 [Patent Document 8] U.S. Patent No. 5,397,351 [Patent Document 9] U.S. Patent No. 5,554,185 [Patent Document 10] U.S. Patent No. 5,855,601 [Patent Document 11] U.S. Patent No. 6,168,614 [Patent Document 12] US Patent Application Publication No. 2004 / 0034411 [Non-patent literature]

[0009] [Non-Patent Document 1] Bonhoeffer et al., "Percutaneous Insertion of the Pulmonary Valve," Journal of the American College of Cardiology, 2002, Vol. 39, pp. 1664-1669 [Non-patent document 2] Bonhoeffer et al., "Transcatheter Replacement of a Bovine Valve in Pulmonary Position," Circulation, 2000, 102, 813-816. [Non-patent document 3] Criber, A. et al., "Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis," Circulation, 2002, Vol. 106, pp. 3006-3008. [Non-patent document 4] Anderson HR et al., "Transluminal implantation of artificial heart valves," EUR Heart J., 1992, vol. 13, pp. 704-708 [Non-patent document 5] Anderson, JR et al., "Transluminal Catheter Implantation of New Expandable Artificial Cardiac Valves," EUR Heart J., 1990, Vol. 11, (Suppl.) 224a [Non-patent document 6] Hilbelt SL, "Evaluation of Explanted Polyurethane Trileaflet Cardiac Valve Prosthesis," J Thorac Cardiovascular Surgery, 1989, 94, 419-429 [Non-Patent Document 7] Block P C, "Clinical and Hemodyamic Follow-Up After Percutaneous Aortic Valvuloplasty in the Elderly," The American Journal of Cardiology, October 1, 1998, Vol. 62 [Non-patent document 8] Boudjemline, Y., "Steps Toward Percutaneous Aortic Valve Replacement," Circulation, 2002, Vol. 105, pp. 775-558 [Non-Patent Document 9] Boudjemline, Y., "Percutaneous Implantation of a Valve in the Descending Aorta in Lambs," EUR Heart J., 2002, Vol. 23, pp. 1045-1049 [Non-Patent Document 10] Kulkinski, D., "Future Horizons in Surgical Aortic Valve Replacement: Lessons Learned During the Early Stages of Developing a Transluminal Implantation Technique," ASAIO J, 2004, Vol. 50, pp. 364-368 Summary of the Invention [Problem to be solved by the invention]

[0010] When replacing an implanted cardiac prosthesis using these percutaneous techniques, the physician or clinician needs to know certain characteristics of the particular original prosthesis so that they can select a replacement valve that is appropriate for use with the original prosthesis. For example, information such as the make, type, model, features, size, date, or other characteristics of the original prosthesis can guide the physician or clinician in selecting an appropriate replacement valve. [Means for solving the problem]

[0011] In one aspect, the present disclosure provides a method for implanting a replacement prosthetic heart valve within an original cardiac prosthesis, the method comprising the steps of detecting at least one information marker of the original cardiac prosthesis, selecting a replacement prosthetic heart valve based on information provided by the at least one information marker of the original cardiac prosthesis, and positioning the replacement prosthetic heart valve within an opening defined by the original cardiac prosthesis.

[0012] In another aspect, the present invention provides a cardiac prosthesis, including a prosthetic heart valve or valvuloplasty prosthesis, including at least one information marker indicating one or more of the make, type, model, features, size, and date associated with the cardiac prosthesis.

[0013] In another aspect, the present invention provides a combination of an original cardiac prosthesis and a replacement prosthetic heart valve, wherein the original cardiac prosthesis includes at least one information marker indicating one or more of the make, type, model, features, size, and date associated with the original cardiac prosthesis.

[0014] These and other aspects of the present disclosure will become apparent from the following detailed description. However, the above summary should in no way be construed as a limitation on the claimed subject matter, which subject matter is defined solely by the appended claims, as they may be amended during prosecution.

[0015] Throughout this specification, reference is made to the following accompanying drawings, in which like elements are designated with like reference numerals and in which: [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a schematic side view of one embodiment of a native prosthetic heart valve. [Figure 2] FIG. 1 is a schematic side view of one embodiment of a replacement prosthetic heart valve. [Figure 3] FIG. 3 is a schematic plan view of the replacement prosthetic heart valve of FIG. 2. [Figure 4] 3 is a schematic side view of the replacement prosthetic heart valve of FIG. 2 positioned relative to the original prosthetic heart valve of FIG. 1. [Figure 5] FIG. 5 is a schematic plan view of the valve and valve frame of FIG. 4. [Figure 6] 1 is a schematic perspective view of one embodiment of an annuloplasty prosthesis. [Figure 7] 7 is a schematic side view of the replacement prosthetic heart valve of FIG. 2 positioned relative to the annuloplasty prosthesis of FIG. 6. DETAILED DESCRIPTION OF THE INVENTION

[0017] In general, the present disclosure provides various embodiments of cardiac prostheses that include at least one information marker. In some embodiments, the information marker can be detected using any suitable clinical imaging technique, such as fluoroscopy, magnetic resonance imaging (MRI), or echocardiogram. The information marker can provide a physician or clinician with information about the original cardiac prosthesis being implanted, such as one or more of the manufacturer, type, model, features, size, and date associated with the cardiac prosthesis. This information can assist a clinician in determining which replacement prosthetic heart valve to implant in a patient that is compatible with the original cardiac prosthesis or can meet re-intervention requirements for a particular original cardiac prosthesis.

[0018] These information markers may also be useful in an emergency to assist a physician or other healthcare provider in determining whether a patient has an implanted cardiac prosthesis, and if so, the make, model, etc. of the prosthesis, and whether any special precautions are necessary when treating the patient in an emergency given the implanted prosthesis.

[0019] Markers can convey information in multiple ways. For example, a shape included as part of the marker can be defined in part by a "cut-out" section of radiopaque material. As a specific example, a manufacturer's logo can be cut out of an otherwise continuous surface of radiopaque material, and an image of this cut-out section can be used to identify the product manufacturer. Other cut-out shapes can represent models of heart valves, etc.

[0020] In some embodiments, when such a marker is viewed using imaging techniques, the cut-out portion appears as a "negative" image of the information it is intended to convey - that is, it is not the presence of radiopaque material that conveys the information, but rather the absence of some of such material (i.e., the "cut-out" portion).

[0021] In general, the various disclosed information marker embodiments can be included in any suitable cardiac prosthesis. For example, in some embodiments, the original cardiac prosthesis can include a original prosthetic heart valve, such as the prosthetic heart valve 10 of FIG. 1. In other embodiments, the original cardiac prosthesis can include an valvuloplasty prosthesis, such as the valvuloplasty prosthesis 80 of FIG. 6.

[0022] Features of the present disclosure can be used to replace aortic, mitral, pulmonary, venous, gastric, and / or tricuspid valves. In some embodiments, the prosthetic heart valves of the present disclosure are well suited for intravascular delivery (with or without cardiopulmonary bypass and with or without high-frequency pacing). Methods associated with the present disclosure can be repeated multiple times, allowing multiple cardiac prostheses of the present disclosure to be attached one above the other or within each other, as needed or desired.

[0023] FIG. 1 is a schematic side view of one embodiment of a prosthetic heart valve 10. If the valve 10 was implanted in a patient prior to replacement with a replacement prosthetic heart valve described herein, the valve 10 may be an original prosthetic heart valve. The valve 10 is a typical valve configuration that can be implanted in a patient's heart, such as by suturing or otherwise securing it within the patient's native heart valve region. The native heart valve referred to herein may be any of the human heart valves (i.e., mitral, tricuspid, aortic, or pulmonary valves), and the type and orientation of the implanted (e.g., surgically implanted) prosthetic heart valve 10 corresponds to the particular form, shape, and function of the native heart valve into which it is implanted. Typically, the valve 10 has multiple leaflets attached to its interior region, although these leaflets are not shown in this illustration for clarity. The prosthetic heart valve 10 may be any suitable heart valve, such as a surgically implanted prosthetic heart valve or a transcatheter prosthetic heart valve.

[0024] Generally, the valve 10 includes a valve structure 12 that includes a stent structure 14 having a plurality of stent posts, or commissure posts 16, extending from the stent structure 14. All or a portion of the valve structure 12, including the stent structure 14 and stent posts 16, can be covered by a flexible covering, which can be tissue, polymer, fiber, or fabric material, etc., to which the leaflets (not shown) of the heart valve 10 are attached, such as by sewing. The stent structure 14 can also be in wire form. Furthermore, as is known in the art, the internal structure of each of the stent posts 16 can be formed from a material that is rigid but allows for some elastic bending. This structure allows the stent posts 16 to transition from the orientation shown in FIG. 1 to a biased orientation by application of an external force. When the external force is removed or reduced, the stent posts 16 can again return to the orientation shown in FIG. 1. Alternatively, the stent posts can be at least slightly tilted toward or away from the central axis of the valve 10.

[0025] The valvular structure 12 is generally tubular defining an opening or interior region 20 (referred to generally) extending from an inflow end 22 to an outflow end 24. The opening 20 is essentially surrounded by the valvular structure 12, and the leaflets mounted within the valvular structure 12 selectively allow fluid to flow into and out of the lumen of the native heart valve into which it is to be implanted. That is, the opening 20 selectively opens and closes relative to the lumen of the native heart valve into which it is to be inserted through the movement of the leaflets.

[0026] In some patients, the prosthetic heart valve 10 is implanted using typical surgical techniques, with the stent ring 14 sewn or attached to the annulus or margin of the native heart valve. Alternatively, the artificial valve may be placed within the patient using minimally invasive techniques to hold the valve in place, such as, for example, U-clips, or various other techniques and mechanisms used in minimally invasive and / or percutaneous implantation of novel prosthetic heart valves.

[0027] Prosthetic heart valves used in accordance with the devices and techniques of the present disclosure (e.g., the heart valve 10 and replacement prosthetic heart valve 50 described herein) can include a variety of different configurations, such as prosthetic heart valves with tissue leaflets or synthetic heart valves with polymer leaflets, etc. As such, these heart valves can be specifically configured to replace any heart valve.

[0028] In the illustrated embodiment, the valve 10 includes at least one information marker 70. The at least one information marker 70 is positioned at any suitable location on or within the valve 10, such as, for example, on the stent structure 14 or on the valve's sealing skirt. Furthermore, the at least one information marker 70 can include any suitable information. For example, in some embodiments, the at least one information marker 70 can indicate one or more of the make, type, model, features, size, and date associated with the prosthetic heart valve 10 using one or more items or indicia of any suitable size that can be detected by a physician using a suitable visualization technique. The at least one information marker 70 can be formed using any suitable technique and can include any suitable material, as further described herein. In some embodiments, the at least one information marker 70 can be radiopaque.

[0029] 1 includes one information marker 70, any suitable number of information markers may be included, and in some embodiments, two or more information markers are included, each of which is the same, e.g., conveying the same information. In other embodiments, two or more information markers 70 may each include different information. For example, one information marker may include information regarding the manufacturer of valve 10, and another information marker may include information regarding the date the valve was manufactured or surgically implanted.

[0030] As shown in FIG. 1 , at least one information marker 70 includes a plurality of individual items or indicia, shown as an “X,” a “2,” and an “A.” A marker 70 may include a greater or lesser number of such items. In the illustrated embodiment, the items are shown as a string of letters. In other embodiments, the marker 70 may have individual items arranged in another manner, such as a two-dimensional array of letters or some other two-dimensional pattern. In some embodiments, the marker 70 may include a three-dimensional array of items, where not all items are aligned in the same plane as the other markers. This three-dimensional arrangement may be useful for allowing the marker to be viewed from multiple angles, such as when the valve 10 is in various positions or orientations relative to the imaging device. In some embodiments, at least one information marker 70 may include multiple example sets of items, each arranged in a different plane, such that the information is viewable from multiple directions.

[0031] As described herein, a particular item may be assigned meaning based on the position the item occupies. For example, the first one or more items in a consecutive series of items (e.g., item "X") may be designated to represent a model of a prosthetic heart valve 10. The second one or more items in the consecutive series may represent a feature set of the valve 10, and so on. If a two-dimensional or three-dimensional array or other pattern is used to form at least one information marker 70, items within the array or other pattern may likewise be assigned a particular meaning based on the item's position. In this manner, the position of the item, as well as the item itself, may be used to convey information related to the valve 10.

[0032] 1, each of the items included in the at least one information marker 70 is alphanumeric. In some embodiments, the marker 70 may alternatively or additionally include any other type of symbol or geometric shape. Such symbols may be predetermined (e.g., #, %, @, etc.) or entirely arbitrary (e.g., a symbol defined by the manufacturer, such as the manufacturer's logo). In other embodiments, the at least one marker 70 may include a barcode, a QR code, a binary code, or other suitable code.

[0033] In some embodiments, each of the items in the set of items used to form marker 70 can have similar characteristics, such as being created through a common manufacturing process, being formed from the same material, having approximately the same size (e.g., length, width, shape, and / or thickness of material), having similar feature(s) used to secure or maintain the position and / or orientation of the items, etc. Having a common characteristic (e.g., size) allows for a combination of selected items to be easily incorporated into the same marker.

[0034] The symbols in marker 70 of FIG. 1 can be said to provide a "positive" outline of the information to be conveyed. As described herein, this means that the material used in marker 70 forms the actual cut-out letters. Specifically, the letters "X," "2," and "A" in this example are cut or otherwise formed from a radiopaque material. The remainder of marker 70 (i.e., the body bearing the radiopaque material) can be formed from a non-radiopaque material, such as a polymer. This positive image of the information contrasts with a negative image, in which a portion of the radiopaque material is cut out to provide the information. Specifically, if the letters "A," "B," and "C" were cut out of a sheet of radiopaque material, the cut-out image would be visible when marker 70 was viewed using imaging techniques, similar to shining a light through a window in a darkened room to reveal the outline of the window on an adjacent wall. While both types of images are contemplated herein in various embodiments, using a positive image of the type shown in FIG. 1 can provide a marker 70 that is easy to identify, especially when the marker is relatively small.

[0035] As described herein above, a marker containing one or more items selected from such a set of items can convey information in a number of ways. First, each item selected for inclusion in the marker can convey information through its unique shape, size, and / or other physical characteristics. For example, an item shaped like the letter "M" has a unique shape that can be assigned a specific meaning (e.g., "This device is MRI safe"). Similarly, an item shaped in the shape of a manufacturing logo can be used to convey the manufacturer of the device. Different items assigned some arbitrary shape can be associated with a model of a heart valve. In this embodiment, the order or other arrangement of the items within the marker may not be as important, since each unique item included in the marker is used to convey the necessary information.

[0036] In some embodiments, the spatial relationship of items included in at least one information marker may be important. For example, an information marker may include a series of three items, "MM1," arranged in a string from back to front on a heart valve. The first item in the string, "M," may indicate the manufacturer of the valve. The next item in the string, "M," may indicate the model of the valve, and the third item in the string, "1," may identify a feature set for the valve. Thus, even if two items in the marker are the same (i.e., "M"), the items have different meanings based on their spatial arrangement within the marker. In yet another example, the first two letters, "MM," may be assigned a specific meaning that indicates a feature set for the valve. Thus, in this example, both the spatial arrangement and the items selected for inclusion in the marker provide information related to the heart valve.

[0037] In other embodiments, the spatial arrangement can have two-dimensional or even three-dimensional aspects that can potentially convey information. For example, a multi-shot molding process can be used to add three-dimensional properties to the information marker. The shape of the three-dimensional marker and / or the location of the item within the three dimensions can be used to convey information.

[0038] Three-dimensional markers can be useful, for example, because they can be read from various directions when the orientation of the heart valve is unknown. In one example, a three-dimensional marker can utilize multiple radiopaque items to convey the same information in multiple planes. For example, two "M" items, both of which convey the device manufacturer, can be positioned in two substantially perpendicular planes within the same three-dimensional marker. This allows an imaging device to easily read at least one of the items when the orientation of the heart valve within the patient is unknown.

[0039] In some embodiments, at least one information marker 70 can be made of a material that allows the information marker 70 to be viewed from the side of the stent post opposite the side on which the marker is located (i.e., "through" the stent post) using certain imaging techniques. Thus, when viewed from the opposite side of the commissure post, these markings will appear rearward-facing or as a mirror image of the original marker due to the directional orientation of the marker. However, in some embodiments, the marker 70 may not be visible to the unaided eye in this "rearward-facing" orientation, and may only be visible in this orientation with the aid of certain visualization devices. In other embodiments, the marker(s) may extend through the entire thickness of the stent or be otherwise provided so as to be visible from both sides without the aid of a visualization device. In other words, any suitable orientation can be utilized with the marker 70 to make it visible or invisible when rearward-facing.

[0040] In some embodiments, at least one information marker 70 provided on or within the heart valve can be made of a radiopaque material so that it is visible from outside the patient's body using appropriate imaging techniques, and / or can have echogenic or other properties. The marker 70 can be made of platinum, iridium, tungsten, barium sulfate, and other radiopaque materials, among others. In some embodiments, the marker 70 can be composed of a material impregnated with a radiopaque or echogenic material, including suture fibers or elastomers such as silicone. In this manner, the marker 70 can be used to provide selected information related to the heart valve.

[0041] At least one information marker 70 can be provided on or in any surface of the heart valve using any suitable technique. In some embodiments, the marker 70 can be placed directly on the surface of the valve. In other embodiments, the marker 70 can be first formed as described herein and then attached to the surface of the valve using any suitable technique. In some embodiments, these pre-formed markers can also be inserted into openings in the stent frame.

[0042] After a period of time, it may be desirable to place or implant a replacement prosthetic heart valve over the previously implanted prosthetic heart valve to functionally replace the old heart valve. This may occur if the previously implanted or repaired prosthetic heart valve is determined to be functionally insufficient due to one or more of a variety of factors, such as stenosis, valve failure, structural thrombosis, inflammation, valve insufficiency, and / or other pathologies. In some embodiments of the present disclosure, regardless of the cause of the insufficiency, rather than performing a relatively complex and invasive open-heart procedure to remove the previously implanted prosthetic heart valve and implant a second similarly configured prosthetic heart valve, the previously implanted or repaired insufficient prosthetic heart valve (e.g., the original prosthetic heart valve 10) is left in place and a replacement heart valve is placed, which functionally replaces the previously implanted prosthetic heart valve. Prior to implanting the replacement valve, the leaflets of the previously implanted insufficient prosthetic heart valve may be removed using various techniques, such as cutters and lasers, or the leaflets may be left in place within the insufficient valve, perhaps using a balloon to increase the size of the orifice, so that they are pushed toward the vessel wall during implantation of the replacement valve, or pushed out prior to replacement.

[0043] To confirm that the valve is properly positioned at the implantation site, several factors can be considered, either alone or in combination, including, for example, (1) absence of paravalvular leak around the replacement valve (these delivery systems take into account intravalvular and paravalvular flow, which has the advantage of allowing testing while blood is flowing through the valve); (2) optimal rotational orientation of the replacement valve relative to the coronary arteries; (3) presence of coronary flow with the replacement valve in place; (4) proper longitudinal alignment of the replacement valve annulus relative to the native patient anatomy; (5) confirmation that the position of the sinus region of the replacement valve does not interfere with native coronary flow; (6) confirmation that the sealing skirt is aligned with anatomical features to minimize paravalvular leak; (7) confirmation that the replacement valve does not induce arrhythmias before final actuation; (8) confirmation that the replacement valve does not interfere with the function of adjacent valves, such as the mitral valve; and (9) confirmation of a normal heart rhythm.

[0044] 2-3 illustrate one exemplary embodiment of a replacement prosthetic heart valve 50. The valve 50 includes a stent structure 52 and a valvular structure 54 located therein and attached to the stent structure 52. The valve 50 further includes a sealing skirt 62 adjacent one end and extending generally around the circumference of the stent 52. In general, the stents described herein include a support structure including a number of strut or wire portions arranged relative to one another to provide the desired compressibility and strength to the heart valve. While other details of various configurations of the presently disclosed stents are described herein, generally, the presently disclosed stents include a generally tubular support structure to which a valvular structure is secured to create a stent-valve.

[0045] Some embodiments of the support structure of the stents described herein can be a series of wires or wire segments arranged to transition from a collapsed state to an expanded state. The stent can further include many individual wires formed of metal or other material that comprise the support structure. These wires can be folded or compressed from the expanded state to a contracted state that significantly reduces the internal diameter of the stent, and are arranged such that, in the collapsed state, such support structure with attached valve can be mounted over a delivery device, such as a balloon catheter. The support structure is configured to be expandable when desired, such as by inflation of a balloon catheter. The delivery system used with such a stent should have the ability to rotate and axially orient the new stent so that it can be properly positioned at the desired location.

[0046] In other embodiments, the wires of the stent's support structure can be formed from a shape-memory material, such as a nickel-titanium alloy (e.g., nitinol). Using this material, the support structure can self-expand from a contracted state to an expanded state, such as by application of heat or energy or removal of an external force (e.g., a compressive force provided by a sheath). Typically, the support structure can be repeatedly compressed and re-expanded without damaging the stent's structure. In some embodiments of the present disclosure, the stent 52 is made from a series of wires that can be compressed and expanded by application and removal of an external force, and can include, for example, a series of nitinol wires with a diameter of approximately 0.011 to 0.015 inches. The stent's support structure can be laser cut from a single piece of material or assembled from many different components. For these types of stent structures, one example of a system that can be used to deliver the stent structure is a retractable sheathed catheter that covers the stent until it is deployed, at which point the sheath is retracted to expand the stent.

[0047] The valve structure 54 includes a plurality of leaflets 56 attached to a stent mechanism 58. The stent mechanism 58 may be a separate component secured within the stent, or may actually be a regular region where two leaflet pieces are sewn to the stent to form a "peak" or commissure region. Generally, the illustrated valve structure described in connection with the figures is configured to accommodate multiple leaflets and replace a heart valve (e.g., heart valve 10) having a corresponding number of commissure posts for the multi-leaflet structure. The replacement prosthetic heart valves of the present disclosure generally include three leaflets, but may incorporate more or less than three leaflets.

[0048] As mentioned herein, replacement heart valves can include a variety of different configurations, such as replacement heart valves with tissue leaflets or synthetic heart valves with polymer, metal or tissue-engineered leaflets, and can be specifically configured to replace any heart valve.

[0049] The leaflets can be formed from a variety of materials, including autologous tissue, xenograft materials, or composites known in the art. The leaflets can also be provided as homogenous biological valve structures, such as porcine, bovine, or equine valves. Alternatively, the leaflets can be provided independently (e.g., bovine or equine pericardial leaflets) and later assembled to the support structure of the stent. In another alternative, the stent and leaflets can be fabricated simultaneously, such as with high-strength nanofabricated NiTi films manufactured by Advanced Bio Prosthetic Surfaces (ABPS) of San Antonio, Texas.

[0050] More generally, the combination of the support structure and one or more valve leaflets for a replacement heart valve can have a variety of other configurations different from those shown and described, including any known prosthetic heart valve design. In some embodiments, the support structure with the valve leaflets can be any known expandable prosthetic heart valve configuration, whether balloon-expandable, self-expandable, or deployable (e.g., as described in U.S. Pat. Nos. 5,629,592; 5,729,593; 5,729,594; 5,729,595; and 5,729,595, all of which are incorporated herein by reference).

[0051] 4-5 show one embodiment of a combined original and replacement prosthetic heart valve, with a replacement prosthetic heart valve 50 positioned within the opening 20 of the original prosthetic heart valve 10. For purposes of illustration, portions of the stent structure 14 have been removed to clearly show the opening of the heart valve 10, but typically the stent structure 14 is a continuous ring structure that has already been implanted in the patient.

[0052] In some embodiments, the replacement valve 50 is delivered percutaneously to the area of the native heart valve 10. When the replacement valve 50 comprises a balloon-expandable stent, this can include providing a transcatheter assembly including a delivery catheter, a balloon catheter, and a guidewire. Several delivery catheters of this type are known in the art, and these catheters define a lumen that receives the balloon catheter. The balloon catheter, in turn, defines a lumen through which the guidewire is slidably disposed.

[0053] Additionally, the balloon catheter includes a balloon connected to an inflation source. Note that, as described herein, if the stent being implanted is a self-expanding stent, a balloon is not required, and a sheath or other restraining means is used to maintain the stent in a compressed state until deployment. In any case, for balloon-expandable stents, the transcatheter assembly is sized to accommodate the desired percutaneous approach to the implantation location. For example, the transcatheter assembly can be sized to be delivered to a heart valve via an opening in the carotid artery, jugular vein, subclavian vein, femoral artery, or femoral vein, etc. Essentially, any percutaneous intercostal penetration can be performed to facilitate use of the transcatheter assembly.

[0054] As described hereinabove, any suitable original cardiac prosthesis can include various embodiments of information markers. For example, FIG. 6 is a schematic perspective view of one embodiment of an original cardiac prosthesis including an annuloplasty prosthesis 80. In the embodiment shown in FIG. 6, the annuloplasty prosthesis 80 is a ring defining an opening 84. While the prosthesis 80 is in the form of a ring, it can take any suitable shape, such as, for example, a band. The annuloplasty prosthesis 80 also includes at least one information marker 82 present in any suitable location on or within the prosthesis. All of the design considerations and possibilities related to the at least one information marker 70 of FIG. 1 apply equally to the at least one information marker 82 of FIG. 6.

[0055] Valvuloplasty prosthesis 80 can include any suitable valvuloplasty prosthesis. Furthermore, prosthesis 80 can be used to repair any suitable valve, such as, for example, an aortic valve, a mitral valve, a pulmonary valve, a venous valve, a gastric valve, a tricuspid valve, etc. Prosthesis 80 can then be implanted in a suitable location within a patient using any suitable technique or combination of techniques.

[0056] In some situations, a patient's valve, which has previously been repaired with an annuloplasty prosthesis, may require complete replacement with a replacement prosthetic heart valve, such as replacement prosthetic heart valve 50 of Figure 2. In such situations, a less invasive approach may be to leave the annuloplasty prosthesis in place and position a replacement prosthetic heart valve within the opening defined by the annuloplasty prosthesis.

[0057] For example, Figure 7 is a schematic side view of the replacement prosthetic heart valve 50 of Figure 2 positioned relative to the annuloplasty prosthesis 80 of Figure 6. As shown in Figure 7, the replacement prosthetic heart valve 50 is positioned within an opening 84 defined by the annuloplasty prosthesis 80. The replacement prosthetic heart valve 50 can be positioned within the opening 84 of the annuloplasty prosthesis 80 using any suitable technique or combination of techniques.

[0058] In some embodiments, prior to delivery of the replacement prosthetic heart valve 50, a physician or clinician can detect at least one information marker 70 of the original prosthetic heart valve (e.g., the original prosthetic heart valve 10 of FIG. 1 or the valvuloplasty prosthesis 80 of FIG. 6). The replacement prosthetic heart valve 50 can be selected based on information provided by the at least one information marker of the original cardiac prosthesis (e.g., the at least one information marker 70 of the original prosthetic heart valve 10 of FIG. 1 or the at least one information marker 82 of the valvuloplasty prosthesis 80 of FIG. 6). For example, the at least one information marker 70 can indicate information regarding one or more of the manufacturer, type, model, features, size, and date associated with the original cardiac prosthesis. The physician or clinician can use this information to determine an appropriate replacement prosthetic heart valve 50 that is compatible with the original cardiac prosthesis. Such information can be used to identify a suitable replacement valve in a look-up table, software, or other type of literature that provides instructions regarding the appropriate size, shape, model, etc. of a replacement heart valve that meets the re-intervention requirements for the original heart valve.

[0059] The at least one information marker of the original cardiac prosthesis can be detected using any suitable technique, for example, in some embodiments, the at least one information marker can include a radiopaque material such that the marker can be detected or read using fluoroscopic visualization techniques.

[0060] Prior to delivery, the replacement stent is mounted over the balloon in a contracted state so as to be as small as possible without causing permanent deformation of the stent structure. Compared to the expanded state, the support structure is compressed onto itself and the balloon, defining a smaller inner diameter compared to the inner diameter in the expanded state. While this description is directed to the delivery of a balloon-expandable stent, the same basic procedure also applies to self-expanding stents, where the delivery system does not include a balloon, but in some embodiments includes a sheath or some other type of structure that maintains the stent in a compressed state until it is deployed.

[0061] The transcatheter assembly, with the stent attached to the balloon, is delivered by a delivery catheter through a percutaneous opening in the patient (not shown). The implantation location is identified by inserting a guidewire extending from the distal end of the delivery catheter into the patient's body with the balloon catheter otherwise retracted within the delivery catheter. The balloon catheter is then advanced distally from the delivery catheter along the guidewire to position the balloon and stent at the implantation location. In another embodiment, the stent is delivered to the implantation location through a minimally invasive surgical incision (i.e., non-percutaneously). In yet another embodiment, the stent is delivered through open-heart / open-chest surgery.

[0062] Although one exemplary embodiment of a replacement valve is described herein, it should be understood that the stent of this replacement valve can have at least a slightly different structure than that shown in FIG. 2 . That is, the stent can have the same or different number of crowns at both ends and / or a higher or lower density of wires in the central portion than either end. The stent can further include a central spherical region between the first and second ends of the stent, having a larger diameter than the first and second ends. This spherical region can be configured to generally conform to the contours of the anatomical structure within which the stent is positioned within the patient (e.g., in the sinus region of the aortic valve). Alternatively, or in addition, the stent can include flared portions extending from either side of the central portion. Such a stent can be positioned within a patient's anatomy (e.g., the aorta) so as not to interfere with native anatomical function, while the flared portions extend into the adjacent cardiac chamber to help secure the stent in place.

[0063] During the stent delivery process, it may be advantageous to be able to fully or partially retract the replacement valve into the sheath at any point during the process until the stent is released from the delivery system, which may be useful for repositioning the stent if it is determined that the stent is not correctly positioned relative to the target patient's anatomy and / or the original cardiac prosthesis.

[0064] As discussed above, the at least one information marker can be made of any suitable material, such as a radiopaque material or a radiopaque-penetrating material. Radiopaque materials selected for this purpose can be biocompatible. Such materials include tungsten, tantalum, platinum, gold, barium silicate, and alloys such as Hastelloy® metal.

[0065] The process for forming radiopaque markers from such materials varies. In some embodiments, an etching process can be used to form the marker items. This can be a photoetching process in which a light-resistant coating is applied as a mask to a photosensitive polymer plate. After projecting light onto the plate, the plate is washed to remove the light-resistant material used as a mask. A further washing step can then be used to chemically remove some of the metal exposed to the light. In other embodiments, the light-resistant coating and exposed metal can be removed in a single washing step. Other similar etching processes known to those skilled in the art can also be used.

[0066] Another mechanism for forming radiopaque items for use in the described markers is to stamp items from a sheet of radiopaque material. For example, a ribbon of material can be fed into a die set having male and female portions that stamp out letters. In one example, the stamped items do not completely separate from one another during the stamping process, but remain connected to the larger sheet of such items via break-away tabs. Prior to use, desired items can be separated from the larger sheet of items by twisting, bending, cutting, or otherwise breaking the respective tabs. This allows items, which may be very small individually, to be easily stored and managed as a group until just before use. Using such stamping processes and break-away tabs, radiopaque items with jagged edges and / or burrs can be created.

[0067] Yet another technique for manufacturing radiopaque items is through the use of laser cutting. Laser cutting provides very tight tolerances and smooth edges, allowing for easy reading of small radiopaque markers. However, some materials are expensive or difficult to process using this technique. In particular, this technique can be expensive at mass production levels.

[0068] Yet another option for forming radiopaque items involves a sintering process. According to this technique, a powdered radiopaque material mixed with an adhesive is forced into a mold and baked until all the adhesive dissipates and the radiopaque particles bond together. This type of process creates a porous structure that is susceptible to the molecules of the polymer used during the subsequent molding process, the degree to which the polymer can be accepted depending on the molecular size of the polymer.

[0069] Metal injection molding can also be used to form radiopaque articles. In this scenario, a radiopaque powder or slurry is injected into a mold under pressure. The powder or slurry is then fired until the radiopaque particles bond together. This process, similar to sintering, can also result in a relatively porous radiopaque article.

[0070] Additionally, in some embodiments, the valve suture line or suture pattern may be created using radiopaque impregnated sutures to form valve-related type markers.

[0071] All references and publications cited herein are expressly incorporated by reference in their entirety into this disclosure, except to the extent that they directly contradict this disclosure. Exemplary embodiments of the present disclosure have been described, and reference has been made to possible variations within the scope of the present disclosure. These and other variations and modifications of the present disclosure will become apparent to those skilled in the art without departing from the scope of the present disclosure, and therefore, it is understood that the present disclosure is not limited to the exemplary embodiments set forth herein. Accordingly, the present disclosure is to be limited only by the scope of the claims set forth below.

Claims

[Claim 1] 1. An expandable prosthetic heart valve, comprising: a valve structure, the valve structure comprising: an expandable stent structure including stent features; a plurality of leaflets attached to the stent features, the plurality of leaflets configured to selectively allow fluid to enter or exit the lumen of an implanted native heart valve; The prosthetic heart valve further comprises at least one information marker positioned on the prosthetic heart valve and indicating one or more types or sizes associated with the prosthetic heart valve, the at least one information marker being a three-dimensional marker including two items utilizing multiple radiopaque items capable of conveying the same information in multiple planes, the two items being arranged to exist in two substantially perpendicular planes within the three-dimensional marker.

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