Abstract:
A method and device for marking suture holes in a replacement heart valve leaflet are herein provided. The method includes providing a die having a plurality of posts, each post corresponding to suture location Ink is applied to the posts and the posts are brought into contact with the leaflet, thereby marking the locations of the suture holes on the leaflet.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This Application claims priority to U.S. Provisional Application No. 61/544,487, filed Oct. 7, 2011, the entire contents of which are herein incorporated by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH 
       [0002]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0003]    Repeatability in production of implantable medical devices, for example replacement heart valves, helps to ensure proper function and placement of the medical device. Various types of medical devices have components that are stitched together. 
         [0004]    There remains a need for accurately and repeatably marking stitching locations in medical devices having such components. 
         [0005]    The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists. 
         [0006]    All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. 
         [0007]    Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    In some embodiments, method for making a replacement heart valve comprises providing a valve leaflet and a die, the die having a plurality of posts. The method further comprises applying ink to the posts, pressing the valve leaflet and the die together, contacting the posts with the valve leaflet, and marking the valve leaflet with the ink. Further, the method comprises removing the valve leaflet from the die. 
         [0009]    In some embodiments the method further comprises providing an ink pad; the step of applying ink to the posts comprises pressing the posts into the ink pad. 
         [0010]    In some embodiments the ink is biocompatible. 
         [0011]    In some embodiments the method further comprises perforating the valve leaflet with the posts. 
         [0012]    In some embodiments the posts have pointed ends. 
         [0013]    In some embodiments the method further comprises indenting the valve leaflet with the posts. 
         [0014]    In some embodiments the method further comprises providing a fixture and placing the valve leaflet in the fixture. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0015]      FIG. 1  shows a perspective view of an embodiment of a device for marking valve leaflets. 
           [0016]      FIG. 2  shows an embodiment of a replacement heart valve having three leaflets. 
           [0017]      FIG. 3  shows an embodiment of a die for marking valve leaflets. 
           [0018]      FIGS. 4A and 4B  show an embodiment of a valve leaflet before and after marking. 
           [0019]      FIG. 5  shows an embodiment of the device for marking valve leaflets. 
           [0020]      FIG. 6  shows an embodiment of the die for marking and cutting valve leaflets. 
           [0021]      FIG. 7  shows an embodiment of the device for sequentially cutting and marking valve leaflets. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    While this invention may be embodied in many different forms, there are described in detail herein specific embodiments. This description is an exemplification of the principles of the invention and is not intended to limit it to the particular embodiments illustrated. 
         [0023]    For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated. 
         [0024]    In some embodiments, a device for making a replacement heart valve comprises a die for marking stitch holes in a valve leaflet. Suture material is subsequently inserted through the stitch holes to stitch valve leaflets together, thereby forming a replacement heart valve. 
         [0025]    In some embodiments, a device  10  comprises a die  12  and a press  14 . In some embodiments, the die  12  is pushed into a leaflet  16  with press  14 . Further, in some embodiments, the device  10  comprises an ink pad  18  and a table  20  on which the ink pad  18  is placed. 
         [0026]    Turning to  FIG. 2 , a replacement heart valve  22  is shown therein having a plurality of leaflets  16  which, in some embodiments, are sewn together along sides  31  and  33 . Prior to sewing the leaflets  16  together, however, the stitching pattern  24  is marked on the leaflets  16 . In some embodiments, the stitching pattern  24  is marked on the leaflet  16  via die  12  ( FIG. 1 ). 
         [0027]    As discussed herein, the leaflet  16  is presented in various stages of manufacture. In particular, reference numeral  16  is used herein to refer to the leaflet generally, in any of the stages of manufacture. Reference numeral  16   a  is used herein to refer to the “leaflet blank,” from which the leaflet  16  is cut. Reference numeral  16   b  is used herein to refer to the “cut leaflet,” and reference numeral  16   c  is used herein to refer to the “marked leaflet.” 
         [0028]    Turning to  FIG. 3 , the die  12  comprises a plurality of posts  26 . The posts  26  correspond with stitching pattern  24  on the leaflet  16  ( FIG. 2 ). In particular, in some embodiments, each of the posts  26  corresponds with a stitch hole  28  ( FIG. 2 ). In this way, the stitching pattern  24  is marked on a cut leaflet  16   b  ( FIG. 4A ), via die  12  and posts  26 , to produce a marked leaflet  16   c  ( FIG. 4B ). In some embodiments, the stitching pattern  24  is marked on the leaflet  16  with ink  34 . In some embodiments, however, the stitching pattern  24  is marked on the leaflet  16  by indenting or perforating the leaflet  16  with the posts  26  ( FIG. 3 ). Further, in some embodiments, the leaflet  16  is indented or perforated with posts  26  having ink thereon. In this way, the marked leaflet  16   c  will have stitch holes  28  through which suture material  30  can be threaded. Additionally, the leaflet material  38  immediately surrounding the stitch holes  28  will be marked with ink  34 , thereby providing improved visibility for stitching. 
         [0029]    Returning to  FIG. 1 , in some embodiments, the die  12  is connected to a pneumatic cylinder  36 . In some embodiments, the table  20  is oriented such that the die  12  is located over ink pad  18 . Subsequently, the pneumatic cylinder  36  is actuated, moving the die  12  into contact with the ink pad  18  and applying ink  34  to posts  26  ( FIG. 3 ). The pneumatic cylinder  36  is again actuated to raise the die  12 ; the die  12  is relocated over the leaflet  16 . In some embodiments, the table  20  is indexed to reorient the leaflet  16  and ink pad  18 . The pneumatic cylinder  36  can also be reoriented. 
         [0030]    In some embodiments, the die  12 , with posts  26 , is then lowered onto the cut leaflet  16   b  to mark, indent, and/or perforate the leaflet material  38  ( FIGS. 4A , B). The die  12  is then lifted and the marked leaflet  16   c  is removed from the table  20 . 
         [0031]    In some embodiments, multiple cut leaflets  16   b  can be stacked and perforated simultaneously. Further, in some embodiments, the posts  26  comprise a pointed end  40 , for example as shown in  FIG. 3 . In some embodiments, the posts  26  are individually placed in the die  12 . 
         [0032]    As shown in  FIG. 5 , in some embodiments, a leaflet blank  16   a  is placed on a plastic cutting pad  48 . In some embodiments, for example as shown in  FIG. 5 , the leaflet blank  16   a  comprises leaflet material  38  that has not been cut into its final configuration. In this way, in some embodiments, the die  12  marks, indents, and/or perforates the leaflet blank  16   a  and, at the same time, cuts the leaflet blank  16   a  into a desired shape for assembly. Further, in some embodiments, the plastic cutting pad  48  comprises a flat sheet of soft plastic material that does not dull the die  12  as the die  12  cuts and/or perforates the leaflet  16 . 
         [0033]    Turning to  FIG. 6 , an example of a die  12  having a leaflet cutter  42  and posts  26  is shown therein. The die  12  having a leaflet cutter  42  and posts  26  can simultaneously cut and mark or perforate the leaflet  16 . In some embodiments, the posts  26  are spring loaded so they can recess into the die base  44 . In this way, the posts  26  retract, at least partially, into the die base  44  as the leaflet cutter  42  is lowered onto the leaflet blank  16   a  ( FIG. 5 ). Retraction of the posts  26  during cutting of the leaflet blank  16   a  helps to prevent damage to the posts  26 . As further shown in  FIG. 6 , in some embodiments, the leaflet cutter  42  comprises a perimeter  50  having a curved bottom edge  52 , two opposed inwardly extending side edges  54 , two lower sleeve edges  56 , two sleeve end edges  58 , two upper sleeve edges  60 , and a flat top edge  62 . Additionally, as shown in  FIG. 6 , the leaflet cutter  42  comprises a cutting surface  64  along the perimeter  50 . In some embodiments, the cutting surface  64  is sharpened, having a beveled edge or the like. 
         [0034]    With reference to  FIG. 7 , in some embodiments the device  10  comprises a cutting die  112  having a backing plate  114 . In some embodiments, the backing plate  114  has a plurality of holes  46  therein. Further, the cutting die  112  is attached to a first rod  116 , which, in some embodiments, is connected to a pneumatic cylinder, for example as discussed with respect to  FIG. 1 . Additionally, in some embodiments, the device  10  comprises a marking die  113 , having posts  26  for marking the leaflet  16 . The marking die  113  is attached to a second rod  117 . And, in some embodiments, the second rod  117  is attached to a pneumatic cylinder. 
         [0035]    In some embodiments, the cutting die  112  is first lowered onto the leaflet blank  16   a  to cut the leaflet  16 . Subsequently, the marking die  113  is lowered and the posts  26  are inserted through the holes  46 , thereby marking the leaflet  16  with ink  34  ( FIG. 1 ). Subsequently, the cutting die  112  and the marking die  113  are raised and the marked leaflet  16   c  is removed. 
         [0036]    In some embodiments, the leaflet blank  16   a  is cut into shape before being placed on the table  20 . 
         [0037]    In some embodiments, the ink  34  is biocompatible, for example a food grade ink. In some embodiments, the ink  34  is Guideline Printing Blue Ink by Caloric Color in Garfield, N.J. Guideline Printing Blue Ink is comprised of: 
       (TFE 461 Ceramic Blue) 60105700 Ammonium Perfluorooctanoate (CAS 3825-26-1); 
     CI Pigment Blue 28 (CAS 1345-16-0); 
     Cobalt Aluminate Spinel (CAS 1345-16-0); 
     Octyl or Nonyl Phenoxypolyethoxyethanol (CAS 9002-93-1 or 9016-45-9); 
     Polytetrafluoroethylene (CAS 9002-84-0); 
     Surfactant (CAS 9016-45-9) Trace Amounts 
       [0038]    The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. The various elements shown in the individual figures and described above may be combined or modified for combination as desired. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. 
         [0039]    Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim  1  should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below. 
         [0040]    This completes the description of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.