| Apparatus and methods for making leaflets and valve prostheses including such leaflets -> Monitor Keywords |
|
|
 
Apparatus and methods for making leaflets and valve prostheses including such leafletsRelated Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Heart Valve, Flexible Leaflet, Leaflet Made Of Biological Tissue, Supported By Resilient FrameApparatus and methods for making leaflets and valve prostheses including such leaflets description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070203576, Apparatus and methods for making leaflets and valve prostheses including such leaflets. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application is a continuation of application Ser. No. 11/144,254, filed Jun. 3, 2005. FIELD OF THE INVENTION [0002] The present invention relates generally to apparatus and methods for making bioprosthetic valve assemblies, and more particularly, to apparatus and methods for forming valve leaflets including alignment holes, e.g., from biological tissue, and for assembling such leaflets into laminate assemblies and/or prosthetic heart valves. BACKGROUND [0003] Bioprosthetic heart valves can replace defective native or previous prosthetic valves in patients. Bioprosthetic heart valves generally include a plurality of leaflets attached or otherwise coupled to a frame, stent, or other support structure. The leaflets may be formed from a synthetic material or biological tissue, such as bovine pericardium. [0004] Sutures may be used to secure the leaflets to the support structure of the valve. Typically, a person, such as physician or even a specially trained seamstress, uses a needle and suture thread to pass one or more sutures through the leaflet and the support structure. This process is generally a manual operation and, consequently, may introduce a degree of variation between different sutures placed on a single valve. For example, the placement or even tightness of the individual sutures on a prosthetic valve may vary to some extent even with the most skilled artisan. The variation in which the sutures are placed in the valve may adversely impact the hemodynamic performance of the leaflets after they are secured to the support structure. For example, the particular location of a suture may impact the stress and/or strain characteristics of the leaflet. [0005] In addition, in a multiple leaflet prosthetic valve, one or more leaflets may have different performance characteristics from the remaining leaflets because one or more sutures are inserted slightly off from their desired locations. Variability is thus introduced within a single valve (e.g. intra-valve variability), which may adversely impact the valve's hemodynamic performance. Similarly, even if there is no variability between individual leaflets on a single valve, variability may be introduced between different valves (e.g., inter-valve variability). This latter problem may arise, for example, because a number of different persons are employed to affix the individual leaflets to support structures or otherwise assemble the valves. [0006] U.S. Pat. No. 5,662,705 discloses a method of manufacturing and testing a tissue heart valve during open heart surgery. A piece of autologous tissue from the body of the patient is cut with a plurality of holes being formed in the tissue by a cutting die. The tissue is situated between first and second stents so that the holes are registered with corresponding tissue alignment members in one of the stents, and the stents are positioned together to securely clamp the tissue therebetween. [0007] In some prosthetic heart valve designs, the suture holes may be located close to the edge of the leaflets. When such leaflets are formed from bovine pericardium or other biological tissue, a die cutter may have difficulty punching or otherwise forming holes near or adjacent to the edge of the leaflets. [0008] Thus, apparatus and methods for making leaflets and/or prosthetic valves that reduce intra-valve and/or inter-valve variability may be useful. SUMMARY OF THE INVENTION [0009] The present invention is directed generally to prosthetic valve assemblies and to apparatus and methods for making them, and, more particularly, to apparatus and methods for forming leaflets, e.g., from biological tissue, and/or for securing leaflets to a frame or other support structure using alignment holes formed in the leaflets, e.g., to make prosthetic valve assemblies. The alignment holes may accurately and/or precisely secure the leaflets to the support structure using standard suturing techniques. The present invention is also directed to leaflet laminate components, valve members, and other structures, and to apparatus and methods for assembling them. [0010] In accordance with a first embodiment, a method is provided for forming a bioprosthetic heart valve from a layer of tissue using a cutting apparatus, e.g., a non-contact cutting apparatus, such as a laser cutting system or high-pressure water jet system. Alternatively, a die-cutter or other mechanical cutter may be used. [0011] One or more leaflets may be cut from the layer of tissue, e.g., using a predefined template, which may include forming a plurality of alignment holes in the leaflet(s). A support structure may be provided having a plurality of alignment holes corresponding to alignment holes in each leaflet. The leaflet may be secured to the support structure, e.g., by securing one or more sutures through each set of alignment holes in the leaflet and the support structure. [0012] In one embodiment, the leaflet may include a generally flat edge defining opposing ends, and a crescent-shaped base extending from the edge to define an apex. The leaflet may include at least three alignment holes, e.g., one hole located at or adjacent the apex, and one alignment hole located at or near each opposing end. Optionally, the leaflet may include one or more additional alignment holes, e.g., along one or more edges between the three alignment holes just described. For example, alignment holes may be provided in the leaflet that are arranged symmetrically about an axis intersecting the alignment hole located at the apex of the leaflet. [0013] In accordance with another embodiment, a bioprosthetic heart valve includes a frame and one or more leaflet support structures carrying valve leaflets. The valve may have multiple leaflet support structures, e.g., three, that may be disposed substantially symmetrically around the frame. Each leaflet and support structure may include a plurality of alignment holes therein. The leaflets may be secured to the support structures, e.g., by one or more sutures extending through the alignment holes in the leaflets and support structures. [0014] In one embodiment, each leaflet support structure may include a crescent-shaped strut and/or a laminate structure. For example, the support structure may include a curved strut having an alignment hole located at its apex and an alignment hole at each end of the strut. The holes in the leaflet may be arranged symmetrically about the leaflet in a similar configuration to facilitate securing the leaflet to the support structure. [0015] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0016] FIG. 1 illustrates a non-contact (e.g. laser-based) cutting apparatus for forming bioprosthetic leaflets. [0017] FIG. 2 illustrates exemplary components of the laser-based system of FIG. 1. [0018] FIG. 3 illustrates a target material located on a table of a laser system, such as that shown in FIG. 2. [0019] FIG. 4 is an enlarged plan view of a bioprosthetic leaflet having a plurality of pre-formed alignment holes therein. [0020] FIG. 5A is a perspective view of an exemplary embodiment of a valve frame that may be included in a valve assembly. Continue reading about Apparatus and methods for making leaflets and valve prostheses including such leaflets... Full patent description for Apparatus and methods for making leaflets and valve prostheses including such leaflets Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Apparatus and methods for making leaflets and valve prostheses including such leaflets patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Apparatus and methods for making leaflets and valve prostheses including such leaflets or other areas of interest. ### Previous Patent Application: Methods and devices for delivery of prosthetic heart valves and other prosthetics Next Patent Application: Accommodating intraocular lens system having circumferential haptic support and method Industry Class: Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor ### FreshPatents.com Support Thank you for viewing the Apparatus and methods for making leaflets and valve prostheses including such leaflets patent info. IP-related news and info Results in 0.11732 seconds Other interesting Feshpatents.com categories: Novartis , Pfizer , Philips , Polaroid , Procter & Gamble , 174 |
 * Protect your Inventions * US Patent Office filing 
PATENT INFO |
|
