The present invention relates generally to treatment of cardiac heart disease. More particularly, the present invention relates to implantable valve prostheses for implantation into the cardiac system.
All four of the valves in the heart are passive structures in that they do not themselves expend any energy and do not perform any active contractile function. They consist of moveable “leaflets” that open and close in response to differential pressures on either side of the valve. The problems that can develop with valves can generally be classified into two categories: (1) stenosis, in which a valve does not open properly, and (2) insufficiency (also called regurgitation), in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve or in different valves. Both of these abnormalities increase the workload placed on the heart. The severity of this increased stress on the heart and the patient, and the heart's ability to adapt to it, determine the treatment options that can be pursued. In some cases, medication can be sufficient to treat the patient, which is the preferred method of treatment; however, in many cases defective valves have to be repaired or completely replaced in order for the patient to live a normal life.
The two general categories of valves that are available for implantation into the cardiac system are mechanical valves and bioprosthetic or tissue valves Mechanical valves have been used for many years and encompass a wide variety of designs that accommodate the blood flow requirements of the particular location where they will be implanted. Although the materials and design features of these valves are continuously being improved, they do increase the risk of clotting in the blood stream, which can lead to a heart attack or stroke. Thus, mechanical valve recipients must take anti-coagulant drugs for life to lessen the potential for blood clot formation. Further, mechanical valves can sometimes suffer from structural problems that may force the patient to have additional surgeries for further valve replacement.
Bioprosthetic valves, which are also referred to as prosthetic valves, generally include both human tissue valves and animal tissue valves. The designs of these bioprosthetic valves are typically relatively similar to the design of the natural valves of the patient and advantageously do not require the use of long-term anti-coagulant drugs. Human tissue valves are typically not available in large quantities, however, since they must be removed from deceased persons who have elected organ donation. On the other hand, animal tissue valves are more widely available for the patients who require valve replacement due to the large numbers of animals routinely processed at meat processing facilities, for example. The most common types of animal tissue valves used include porcine aortic valves, and bovine and porcine pericardial valves, some of which are incorporated with a stent before being implanted in a patient. In the case of pericardial valves, the use of pericardial material to design and make the heart valves provides a much larger range of options than is available when using only harvested valves.
In order to manufacture these pericardial valves, a number of steps must be performed on one or more pieces of pericardium material, where this work is typically done by highly-skilled operators in a controlled environment. Even under these conditions, however, there is concern that minor variations in the valves can occur due to slight differences in the techniques used by individual operators and the variability of materials used. In order to minimize these variations, there is a need to provide reproducible and simple tooling and methods for manufacturing pericardial valves.
The present invention is directed to prosthetic cardiac valves and methods of making such valves. In one embodiment, the invention involves methods and tooling for making valves using sheets or pieces of material, such as pericardium material, polymer or bioengineered film, or other material. The tooling and processes provide an accurate and repeatable system of making pericardial valves in which sheets or pieces of pericardium material are held securely in place relative to each other throughout all of the steps of making the valve. In addition, the methods of the present invention include maintaining consistent alignment of the fixtures and pericardium material throughout the valve assembly process and utilize features that make the tooling components easy to assemble and handle. Certain aspects of the invention can be used to help establish a repeatable sewing and cutting technique for creating a pattern shape for valve leaflets, establishing stitch lengths, and determining the exact placement of stitches.
In one aspect of the invention, a method is provided to secure two pieces of tissue material to each other in a predetermined series of vertical segments connected by arches or arcuate portions that will make up multiple leaflets of a valve. Once the tissue layers are secured to each other in a desired configuration, the tissue assembly can be formed into a tube so that the arches and vertical segments make the leaflets of a valve. The valve can then be secured to a stent to make a stented valve, if desired. In such a configuration, the stent structure may be compressible and expandable to facilitate percutaneous insertion into the heart of a patient, such as with a self-expanding stent or with a stent that is expandable when subjected to outward radial force.
In another aspect of the invention, individual leaflets are constructed, which can then be made into a multi-leaflet valve that will have more than one side seam when assembled into a tubular valve. The leaflets are each constructed from a wall layer of tissue and a leaflet layer of tissue and again are assembled in a way that involves repeatable sewing techniques for creating consistently shaped valve leaflets.
The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein: The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:
Heart valves made using the methods and processes of the invention can be used for replacement of pulmonary valves, aortic valves, mitral valves, or tricuspid valves, in accordance with the methods and valve constructions of the invention described herein. Alternatively, the valves of the invention can be used to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example. The shape, size, material, and configuration of the outer tubular portion of the heart valves described herein can specifically be designed and chosen for the type of valve that is being produced. The valves of the invention can include stented or stentless valves, but in either case, the valves are preferably compressible to a reduced diameter during the implantation process, such as transcatheter implantation, and can be capable of being expanded to a larger diameter once they are in their desired implantation location. The valve assemblies can be used as a surgical sutureless or apical implant, and can be utilized in percutaneous replacement of cardiac valves, for example. One exemplary method for assembling a stented valve of the invention generally includes the manufacture and preparation of a valve segment, then a subsequent mounting or attachment of the prepared valve segment to a stent.
Referring now to the Figures, wherein the components are labeled with like numerals throughout the several Figures, and initially to
The shaped portion of the pattern 22 includes vertical components 27 that correspond to leaflet commissures. The vertical components 27 are provided in pairs, where each vertical component 27 of a pair is spaced from the other vertical component 27 of the pair by a distance that represents the desired width of a leaflet. An arcuate portion 28 is also provided for each pair of vertical components 27, which extends between each pair of vertical components 27. The vertical components 27 are generally linear and are preferably also generally parallel to each other. Alternatively, the vertical components 27 can be arranged in a non-parallel configuration to provide another shape to the attachment pattern, such as a funnel shape, for example. The length of the vertical components 27 can be chosen to correspond to the desired depth of a leaflet, such that a pattern including relatively long vertical components 27 will provide bigger or deeper leaflets than a pattern having relatively short vertical components 27. Thus, the length of the vertical components 27 can advantageously be designed and/or selected to correspond with a desired depth of the leaflets, which selection is not available when using a native valve, for example. In any case, all of the vertical components 27 of a particular pattern 22 can have the same or nearly the same length in order to create leaflets that are identically or nearly identically shaped and sized for a certain valve. In that respect, all of the vertical components 27 can also be spaced at the same distance from each other, and also can be spaced at a distance from a corresponding edge that will facilitate making the width of all of the shaped portions the same for a particular piece of pericardium material. However, it is also contemplated that the vertical components 27 within a single valve configuration can have different lengths and/or can be spaced at different distances from each other in order to create a valve having leaflets that are not all identically sized and/or shaped.
Any pericardium material used may be at least partially fixed or cross-linked with a buffered gluteraldehyde solution or other solution at some point during the assembly process, in order to make the material easier for an operator to handle and manipulate. In one specific example, a piece of porcine pericardium is obtained, which is rinsed for approximately 10 minutes in a buffered gluteraldehyde solution to partially cross-link the material. U.S. Pat. No. 4,976,733 (Girardot), titled “Prevention of Prosthesis Calcification”, describes a variety of additional exemplary methods of treating pericardium material that may be useful with the systems and methods of the present invention, along with methods for retarding or preventing the calcification of a prosthesis implanted in a mammal. However, such treatments to the material are optional and may be different depending on operator preference, the material chosen, and the like. The piece of pericardium can then be cut to a predetermined shape and size, such as the rectangular pieces of pericardium material 100, 102 illustrated in
The description of the positioning of the tooling components and tissue of an assembly are described herein as having “top” and “bottom” components, which generally corresponds to the figures. However, these terms are used for description purposes and are meant to describe the relative positioning of the components in an assembly. That is, the components could alternatively be reversed so that the top plate of the sewing fixture frame is actually on the bottom of the assembly, for example. Referring again to
After all of the components are assembled, an operator or an automated or semi-automated machine can stitch the layers of tissue 100, 102 to each other along the stitch pattern of the sewing fixture templates. The top plate 10 of the sewing fixture frame and the first (top) sewing fixture template 20 are then removed. A lower cutting fixture middle plate 70 is then inserted between the layers of tissue as shown in
The stitched tissue assembly is then folded in half with the leaflet surface being on the inside of the fold. The locating holes 104 of the tissue layers 100, 102 should be aligned with each other after the tissue is folded to provide consistency of alignment in the final sewing step of
In this step, a reference tab of the stitched tissue should fall within the reference tab window of the final sewing fixture templates 40 (see reference tab window 44 of
As set out above, the two thicknesses of pericardium material can be attached to each other by sewing along a predefined pattern. The suture material used for the sewing process may be provided as a monofilament or multifilament structure made of natural or synthetic material (e.g., nylon or polypropylene), or may alternatively include an elongated metal or metal-composite thread or filament that is suitable for securing layers of pericardium material to each other. The stitching and suturing techniques will typically involve using an elongated thread-like material that may be attached to a needle to perform the securing function, which may either be done by hand or with an automated machine. Referring again to
The sewing plate 160 further includes a “margin of attachment” stitch pattern 166, which includes a series of holes 168 spaced from each other with suture channels 170 between adjacent holes 168. The holes 168 are provided as the location in which a needle will be inserted through the layers of tissue, and the channels 170 are provided for the portions of thread positioned between the holes 168. In this figure, a running stitch pattern is shown, although other stitch patterns can be used. One or more (preferably two) reference lines 172 are provided to show where the leaflet commissure will be created once the side seam is stitched in subsequent operations. Finally, at least one (preferably two) reference stitch lines 174 are provided, which include another series of holes and channels, as described above relative to other stitching patterns. The operator will use this line when stitching the “margin of attachment” stitches and will use the line with the side seam fixture to align the leaflets to each other.
The wall protection plate 180 is a plate that is positioned between two layers of pericardial tissue that are sewn together to create a leaflet. This plate 180 protects the wall tissue layer when the leaflet free margin is cut. This wall protection plate includes open slots 182 that allow the “margin of attachment” stitching and reference line stitching to go through to the wall protection plate. That is, because this plate will need to be removed from between the two layers of tissue, it cannot be sewn into the assembly. This plate is actually a two-piece assembly, as indicated by the break line 184, which allows the plate to be removed from the assembly once the layers of tissue are sewn together and the free margin is cut. The material that makes up these plate pieces is preferably: (1) thin enough to cause only a minimal gap between the two layers of tissue; (2) strong enough to withstand the cutting mechanism used to create the free margin of the leaflet; and (3) soft enough to not dull or otherwise adversely affect the free margin cutting mechanism.
Once the leaflets are sewn, such as is described above, the free margin can be cut. In order to do this, the top leaflet sewing plate is removed (i.e., the plate that is on top of the leaflet layer of pericardial tissue), and the free margin cutting plate (such as one of the cutting plates 200, 210 illustrated in
Next, with regard to a 3-dimensional leaflet construction, an assembly used for sewing includes a leaflet sewing plate on the bottom (e.g., sewing plate 160 illustrated in
In order to form or make a leaflet assembly into a cylindrical or tubular valve using 2-dimensional or 3-dimensional leaflets, its side seams can be sewn using side seam plates 260 of the type illustrated in
In order to provide the features described above, the valve assembly system 300 is provided with a robust and user-friendly pinning system. This system uses concentrated areas of multiple pins along the perimeter of the fixture for holding the tissue. In addition, one embodiment of the valve assembly system is a single-frame system, which provides for easy alignment of tissue. Overall, the assembly can be relatively thin so that it is a handheld device for an operator, although it is possible that the assembly is larger such that it is instead more appropriate for tabletop usage.
Valve assembly system 300 generally includes a top plate 302, a bottom plate 304, at least one frame clamp 306, and a slide pin cover 308. Although tissue is not shown in these Figures, tissue would be held between the top plate 302 and bottom plate 304 during the valve assembly process. Sewing and cutting templates can be slid in and out of the assembly 300 without transferring the tissue to any other fixtures. In this way, once the tissue is secured between the top plate 302 and bottom plate 304, it will not need to be removed until the valve is completely sewn and assembled. Rather, pins 310 or other protrusions can extend from a top face of the bottom plate 304 to secure the tissue in place relative to the top plate 302 throughout the valve assembly process. In addition, peripheral locating pins can be used to ensure proper alignment of the tissue and templates relative to each other.
As illustrated in
Bottom plate 304, illustrated in
One embodiment of slide pin cover 308 may include concentrated areas of holes that correspond with the pins 310 that extend from the holes 322. The assembly may further include at least one finger spring 330 that extends from one or both sides of the pin cover 308. The spring or springs 330 can be used to secure the pin cover 308 to the system 300.
System 300 further includes at least one frame clamp 306 for securing the top plate 302 to the bottom plate 304. The number of frame clamps 306 used can vary in order to achieve the desired clamping of the components to each other, but the assembly 300 preferably includes at least one clamp 306 on three of its sides. As illustrated in the embodiment of
In many of the embodiments described herein, the pericardial valve is prepared to include three leaflets, but may optionally have more or less than three leaflets, which can be formed by varying the number of leaflet and outer tube components. The three leaflet embodiment can be used in areas of the heart that typically have a three leaflet valve, such as the pulmonary valve and aortic valve, although the three leaflet embodiment can also be used as a replacement for the two leaflet mitral valve. Alternatively, a two leaflet or single leaflet embodiment of the valve of the invention is contemplated, which can be used in areas of the heart that typically have a three leaflet valve, such as the pulmonary valve, for example. Certain considerations for blood flow will determine particular parameters of the valve used.
Once a tissue valve is manufactured using the above techniques and tooling, the tissue valve can be attached within a stent, where the stent can be secured to the valve segment in a variety of ways. One procedure that can be used is to suture certain areas of the stent to the valve segment. The suture material may be provided as a monofilament or multifilament structure made of natural or synthetic materials (e.g., nylon or polypropylene), or may alternatively include an elongated metal or metal-composite thread or filament that is suitable for permanently securing the stent to the valve segment in accordance with the present invention. The number and location of suture points can vary, but should include an adequate number of connection points that are positioned in predetermined locations that prevent movement of the stent relative to the valve segment, particularly during the compression of the stent for percutaneous delivery and expansion of the stent for its deployment.
The stented valve can be subjected to suitable chemical fixation and/or bioburden reduction treatments, which may vary considerably depending on the particular requirements for storage and use of the stented valve. Chemical fixation helps to preserve the tissue, render it inert, reduce the risk of host rejection, and/or the like. Chemical fixation may occur by submerging the valve in a suitable reagent for a period of about 3 hours under slight pressure and ambient temperature and then for 72 hours under ambient pressure and temperature. By way of example, a 0.2% by weight gluteraldehyde solution at physiological pH and being phosphate buffered may be used for chemical fixation. The valve may then be stored in a suitable storage reagent (e.g., an aqueous solution containing 0.2% by weight gluteraldehyde) until subsequent use. Bioburden reduction may be carried out by submerging the tissue in a suitable reagent for a period of 48 to 72 hours at ambient temperature. By way of example, an aqueous solution containing 1% by weight gluteraldehyde and 20% by weight isopropyl alcohol at physiological pH and being phosphate-buffered may be used for bioburden reduction. This solution would be suitable for use as a packaging solution as well. A variety of fixation tines, concentrations, pH levels and chemicals can be used in accordance with the invention. After suitable treatments to the valve are complete and after appropriate rinsing of the valve, the device can be used for implantation into a human.
The stented valve may then be used with a system for delivering the valve segment to the desired location within a patient. The delivery system may include, for example, an outer sheath overlying an inner balloon catheter, where the outer sheath includes an expanded distal portion, within which the stented valve is located. The stented valve can be compressed around a single or double balloon located on the inner catheter. A tapered tip is mounted to the distal end of the inner catheter and serves to ease the passage of the delivery system through the patient's vasculature. The system also may include some type of guidewire to guide the delivery system to its desired implant location. Another alternative delivery system that can be used, in particular, for stented valves having a self-expanding stent, includes a catheter that does not have balloons, but instead includes a sheath or other mechanism that maintains the self-expanding stent in its compressed condition until it is desired to allow it to expand. When such a self-expanding stent is properly positioned in the patient, the mechanism that keeps the stent compressed can be retracted or otherwise removed to allow for expansion of the stent against the vessel walls.
The present invention has now been described with reference to several embodiments thereof. The entire disclosure of any patent or patent application identified herein is hereby incorporated by reference. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein, but only by the structures described by the language of the claims and the equivalents of those structures.
The present application claims priority to U.S. Provisional Application Nos. 61/125,202, filed Apr. 23, 2008, and titled “Methods and Apparatuses for Assembly of a Pericardial Prosthetic Heart Valve” the entire contents of which is incorporated herein by reference in its entirety.
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