Abstract:
Systems and methods for supporting a replacement heart valve are presented herein. A bioprosthesis may be stored in a storage container by suspending the bioprosthesis from a support structure. The volume of storage solution may be reduced by using a lid with a boss extending therefrom to displace some of the volume of the storage container. The support structure may rest on the base of the storage container. Additionally, there may be a holder attached to the bioprosthesis above the support structure. The holder-bioprosthesis-support structure may be constrained between the lid and base of the storage container.

Description:
[0001]     This application claims the benefit of U.S. provisional patent application No. 60/589,427, filed Jul. 19, 2004, which is hereby incorporated by reference herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     This invention relates generally to systems and methods for storing and delivering bioprosthetic heart valves. Systems and methods in accordance with the principles of the present invention may be used for storing and transporting bioprosthetic replacements for any of the heart&#39;s valves (e.g., aortic, mitral, pulmonary, and tricuspid). Bioprosthetic replacements such as supra valves may also be stored and transported in accordance with the principles of the present invention. A supra valve may take the place of or supplement the function of the aortic valve, but may be implanted slightly higher in a patient&#39;s aorta than an aortic valve. Several disadvantages to current bioprosthetic storage and delivery procedures are addressed by the present invention.  
         [0003]     Presently, bioprosthetic heart valves are stored in a solution that must be rinsed off before the valve can be implanted. The valve is suspended in a solution to preserve the tissue of the bioprosthesis. Typically, this solution is either formaldehyde-based or gluteraldehyde-based and care must be exercised in the operating room not to contaminate the sterile operating field with the storage solution.  
         [0004]     However, current bioprosthetic heart valve packaging requires the removal of the valve from the storage container before the holder handle may be attached (i.e., the scrub nurse or surgeon may have to reach into the storage solution to retrieve the valve and then remove the structure that was supporting the valve in the jar). Because the jar is completely filled with the storage solution, these cumbersome steps have the potential to contaminate the gloves of the person retrieving the valve. Furthermore, the potential for spilling storage solution in the operating room is high, because the jar is completely filled with storage solution.  
         [0005]     The step of rinsing the valve can be problematic in its own right, because this procedure takes at least six minutes. During these six minutes, a scrub nurse must continue to provide the surgeon with instruments, sutures, etc. However, he or she may also be responsible for rinsing the valve. Resting the valve in the rinse basin may damage the valve, and the rinse process may require the rinser to agitate the rinse solution. Thus, the scrub nurse must attend to both the surgeon and the valve rinse procedure. Furthermore, the valve may stay in the final rinse basin for an extended period if the surgeon is not ready for the valve when the final rinse is complete. Finally, some operating room personnel prefer to attach the holder handle to the valve holder while the valve is resting in the sterile field. For these reasons, it may be desirable to provide a device that would protect the valve if it were set down during the operation.  
         [0006]     Therefore, it is an object of the present invention to provide a heart valve holder and support assembly that could be allowed to rest in the rinse basin during the rinse procedure without having to worry about damaging the valve. Additionally, it is an object of the present invention to reduce the likelihood of spilling storage solution in the operating room and of contaminating any of the persons or surfaces in the operating room.  
         [0007]     A heart valve support and lid liner system directed to these objectives may be implemented with existing heart valve products such as St. Jude Medical&#39;s Biocor and Epic heart valve product lines. However, it should be understood that such support and lid liner systems could be adapted to any existing or future heart valve product lines.  
       SUMMARY OF THE INVENTION  
       [0008]     Valve supports in accordance with the present invention allow the holder handle to be attached to the valve holder as soon as the lid of the jar is removed and while the valve/holder/support assembly is still inside the jar. Supports in accordance with the present invention may be left on the valve until just before the surgeon implants the valve, protecting the valve until it is needed. Such supports may simplify the operating room procedure because the scrub nurse does not have to remove the valve/holder/support from the jar nor remove the support from the valve before attaching the handle. The support may also eliminate the contamination of the scrub nurse&#39;s gloves by the storage solution, which is more likely to occur if the scrub nurse removes the valve from the jar by hand. Such a support may additionally eliminate contamination of an instrument and the risk of dropping the valve if the scrub nurse removes the valve from the jar with an instrument.  
         [0009]     One embodiment of the present invention comprises a clip-like device (e.g., a grip) that attaches to the sewing cuff of a replacement heart valve and supports the valve from below. Supporting the valve in this manner allows the scrub nurse or surgeon to thread the holder handle directly into the valve holder as soon as the lid is removed from the jar. The valve support may remain attached to the replacement valve to protect it until the surgeon is ready to perform the implant procedure.  
         [0010]     In order to secure the valve in the jar vertically, a lid liner with a protrusion in the center may be used to hold the heart valve holder and support assembly in place. This protrusion attaches to the lid and may take up volume within the jar, enabling the use of less storage solution. Therefore, when the lid and lid liner are removed, the fluid level in the jar drops and the fluid is not as likely to spill in the operating room. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]     Further features of the invention, its nature, and various advantages will be more apparent from the following detailed description and the accompanying drawings, in which:  
         [0012]      FIG. 1  is a cutaway perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0013]      FIG. 2  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0014]      FIG. 3  is a view similar to  FIG. 1  showing an enlarged view of the apparatus illustrated in  FIG. 1  and showing a portion of a particular illustrative procedure and related apparatus in accordance with the invention.  
         [0015]      FIG. 4  is a view similar to  FIG. 1  showing a later stage in the illustrative procedure depicted in part by  FIG. 3 , together with related apparatus, all in accordance with this invention.  
         [0016]      FIG. 5  shows an even later stage in the illustrative procedure depicted in part by  FIGS. 3 and 4 , together with related apparatus, all in accordance with this invention.  
         [0017]      FIG. 6  shows an even later stage in the illustrative procedure depicted in part by  FIGS. 3-5 , together with related apparatus, all in accordance with this invention.  
         [0018]      FIG. 7  shows an even later stage in the illustrative procedure depicted in part by  FIGS. 3-6 , together with related apparatus, all in accordance with this invention.  
         [0019]      FIG. 8  shows an even later stage in the illustrative procedure depicted in part by  FIGS. 3-7 , together with related apparatus, all in accordance with this invention.  
         [0020]      FIG. 9  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0021]      FIG. 10  is a cross-sectional view of the apparatus shown in  FIG. 9  taken from line  10 - 10  of  FIG. 9 .  
         [0022]      FIG. 10A  is a view similar to  FIG. 10  showing an enlarged view of detail A of  FIG. 10 .  
         [0023]      FIG. 10B  is a view similar to  FIG. 10  showing an enlarged view of detail B of  FIG. 10 .  
         [0024]      FIG. 11  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0025]      FIG. 12  is an isometric view of the apparatus shown in  FIG. 11 .  
         [0026]      FIG. 13  is an isometric view of the apparatus shown in  FIG. 11 .  
         [0027]      FIG. 14  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0028]      FIG. 15  is a view similar to  FIG. 14  showing the apparatus illustrated in  FIG. 14 .  
         [0029]      FIG. 16  is a cross-sectional view of the apparatus shown in  FIG. 15  taken from line  16 - 16  of  FIG. 15 .  
         [0030]      FIG. 17  is an isometric view of the apparatus shown in  FIGS. 14-16 .  
         [0031]      FIG. 18  is an isometric view of the apparatus shown in  FIGS. 14-16 .  
         [0032]      FIG. 19  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0033]      FIG. 20  is a cross-sectional view of the apparatus shown in  FIG. 19  taken from line  20 - 20  of  FIG. 19 .  
         [0034]      FIG. 21  is an enlarged detailed cross-sectional view of the apparatus shown in  FIG. 19  taken from line  21 - 21  of  FIG. 19 .  
         [0035]      FIG. 22  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0036]      FIG. 23  is an isometric view of the apparatus shown in  FIG. 22 .  
         [0037]      FIG. 23A  is a view similar to  FIG. 23  showing an enlarged view of detail A of  FIG. 23 .  
         [0038]      FIG. 24  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0039]      FIG. 25  is a cross-sectional view of the apparatus shown in  FIG. 24  taken from line  25 - 25  of  FIG. 24 .  
         [0040]      FIG. 26  is an enlarged detailed cross-sectional view of the apparatus shown in  FIG. 24  taken from line  26 - 26  of  FIG. 24 .  
         [0041]      FIG. 27  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0042]      FIG. 28  is an isometric view of the apparatus shown in  FIG. 27 .  
         [0043]      FIG. 28A  is a view similar to  FIG. 28  showing an enlarged view of detail A of  FIG. 28 .  
         [0044]      FIG. 29  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0045]      FIG. 30  is a cross-sectional view of the apparatus shown in  FIG. 29  taken from line  30 - 30  of  FIG. 29 .  
         [0046]      FIG. 31  is an enlarged detailed cross-sectional view of the apparatus shown in  FIG. 29  taken from line  31 - 31  of  FIG. 29 .  
         [0047]      FIG. 32  is a perspective view of an illustrative embodiment of apparatus in accordance with the principles of the present invention.  
         [0048]      FIG. 33  is an isometric view of the apparatus shown in  FIG. 32 .  
         [0049]      FIG. 33A  is a view similar to  FIG. 33  showing an enlarged view of detail A of  FIG. 33 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0050]     Illustrative apparatus in accordance with the principles of the present invention are illustrated in  FIG. 1 . Such apparatus may include jar  19  and lid  12  to store and transport a heart valve prosthesis that has been prepared for surgical implant. Lid  12  may be fitted with lid liner  14 . Heart valve  11  may be attached to valve holder  13  and support  18 . When valve holder  13 , heart valve  11 , and support  18  are assembled within jar  19  as shown in  FIG. 1 , heart valve  11  is suspended within jar  19  by being vertically constrained between lid liner  14  and the base of jar  19 . The heart valve holder and support assembly may be rotationally constrained by tabs  17  in the base of jar  19 .  
         [0051]     In general, jar  19  contains heart valve  11  with support  18  resting on the base of jar  19  and valve holder  13  resting above heart valve  11 . However, the orientation of heart valve  11  may vary depending on the intended use. For example, a replacement mitral valve may be stored (i.e., held) with the valve leaflets and commissure posts extending downwardly from the level of the valve&#39;s sewing cuff, whereas aortic and supra valves may be held with the valve leaflets and commissure posts extending upwardly from the level of the valve&#39;s sewing cuff.  
         [0052]     Valve holder  13  may include an internal rotating mechanism to deflect the lower ends of the commissure posts radially inward. In the case of a replacement mitral valve, valve holder  13  may engage the sewing cuff of replacement heart valve  11  at locations annularly spaced around the valve. When holding aortic and supra replacement valves, valve holder  13  may be designed to engage the ends of the commissure posts of the replacement heart valve.  
         [0053]     Heart valve  11  should be packaged such that the entire prosthesis is always completely immersed in the storage solution. This is typically achieved by completely filling jar  19  with storage solution. However, lid liner  14  may be designed to displace some of the volume of jar  19 . Thus, jar  19  does not have to be completely filled with storage solution to ensure total immersion of heart valve  11 . Apparatus in accordance with the principles of the present invention may also include holder handle  15 .  
         [0054]     An enlarged detailed view of one embodiment of a support is shown in  FIG. 2 . Support  23  (which may be used as support  18  of  FIG. 1 ) may include finger tabs  22 , ring  24 , struts  29 , and grips  28 . Grips  28  may be designed to grip the sewing cuff or other suitable gripping surface of a prosthetic heart valve. Finger tabs  22  may be squeezably operable to release grips  28  from a supported prosthetic heart valve. Additionally, finger tabs  22  may provide resting support for support  23  within jar  19 . Ring  24  may protect a stored heart valve from colliding with the wall of jar  19  if jar  19  is dropped or subjected to some other form of shock or impact.  
         [0055]     Support  23  may attach directly to the sewing cuff of heart valve  11 . Support  23  may alternatively be attached to valve holder  13 . Some heart valve support products support the holder from above, obstructing the handle attachment means when the storage container is opened. Thus, to attach a handle to the replacement valve and holder, the support must first be removed. Support  23  may support a heart valve from below, and may engage a feature of the replacement valve instead of the holder. This feature enables immediate handle attachment and eliminates the codependence of the holder and support, allowing either component to be changed without affecting the other.  
         [0056]     Supports like support  23  may be adapted for one-step removal. In such designs, ring  24  which connects three upstanding struts  29  may act as a pivot point. When finger tabs  22  below ring  24  are pressed toward the flow axis of the valve, grips  28  rotate away from the valve&#39;s sewing cuff or other engagement surface and release the valve. This feature simplifies the operating room procedure as current valve supports require a more complex method to remove the support from the valve (e.g., multiple disassembly steps, cutting a suture, etc.).  
         [0057]      FIG. 3  illustrates heart valve  11  with holder  13  and support  18  attached by grips  28  after the lid and lid liner have been removed from jar  19 . Holder  13  may be attached to valve  11  by sutures that pass through eyelets  34  and sewing cuff  36 . Holder  13  may have cutting grooves  38  so that sutures securing valve  11  to holder  13  can be easily cut at the appropriate time to remove valve  11  from holder  13 . As shown in  FIG. 3 , holder  13  may include threads  32  for the attachment of holder handle  15  (see  FIG. 1 ).  
         [0058]     As shown in  FIG. 4 , holder handle  15  is threaded into valve holder  13  such that threads  42  of holder handle  15  threadably engage threads  32  of valve holder  13 . This secures valve/holder/support assembly  50  (see  FIG. 5 ) to holder handle  15 . Because threads  32  are exposed upon the removal of the combined lid and lid liner, there is no reason for the scrub nurse or surgeon to actually reach into jar  19  with their sterile, gloved hands. Holder handle  15  is inserted directly into jar  19  to remove assembly  50  (see  FIG. 5 ) from jar  19 . Alternatively, holder handle  15  may snap into holder  13 , or any other suitable attachment mechanism may be used.  
         [0059]     Because holder handle  15  is threaded into valve holder  13 , it is important that support  18  is able to hold the valve securely while holder handle  15  is tightened. To increase the torsional force that can be applied to valve holder  13  before sewing cuff  36  would begin to slip through grips  28  of support  18  (e.g., rotate about the holder handle axis and slide through the grips), small ridges (see, e.g., ridges  210  of  FIG. 21 ) may be added to grips  28 .  
         [0060]      FIG. 5  illustrates assembly  50  removed from jar  19  (not shown). Assembly  50  may include support  18 , heart valve  11 , and holder  13 . Once assembly  50  is removed, heart valve  11  is rinsed. A preferred rinse procedure may include filling three sterile basins with sterile isotonic saline. Assembly  50  and the portion of holder handle  15  that was submerged in the valve storage solution should be fully immersed in the sterile isotonic saline solution of the first basin. The valve may be rinsed in the first basin for a fixed period of time with a gentle back and forth motion. The rinse process may be repeated in each of the three basins. Once the rinse procedure is completed, assembly  50  may be left immersed in the third basin until the surgeon is ready for implantation. Preferably, all of assembly  50  is rinsed, so that everything in  FIG. 5  is sterile and free of aldehyde residuals (or toxic residuals) and ready for the operating environment.  
         [0061]     Once the rinse process is completed, finger tabs  22  below ring  24  are pressed toward the flow axis of the valve (illustrated by arrows  62 ) as shown in  FIG. 6 , rotating grips  28  away from sewing cuff  36  of heart valve  11  (illustrated by arrows  64 ). This releases heart valve  11  and valve holder  13  from support  18 . Because support  18  was rinsed and sterilized with heart valve  11 , the surgeon or scrub nurse is free to squeeze tabs  22  with his or her gloved hand.  
         [0062]     As shown in  FIG. 7 , support  18  is pulled away from heart valve  11  and valve holder  13 . At this point, heart valve  11  and valve holder  13  are ready to be handed to the surgeon for installation in the patient in the assembly shown in  FIG. 8 . Holder handle  15  and valve holder  13  may be removed from the patient in one piece once the installation procedure is completed.  
         [0063]      FIG. 9  shows a top-down view of jar  110 , which is another illustration of a jar in accordance with the principles of the present invention, like jar  19  of  FIG. 1 . To prevent a valve/holder/support assembly, like assembly  50  of  FIG. 5 , from rotating in jar  110  when the handle is threaded into the valve holder, a number of tabs  117  may be added to the bottom of jar  110 , like those shown in  FIGS. 9 and 10 . Tabs  117  interfere with the finger tabs on the heart valve support and prevent the valve/holder/support assembly from rotating freely in the jar.  
         [0064]      FIGS. 9-13  show details of jar  110 , including lid threads  112  and tabs  117 .  
         [0065]     A lid liner, such as lid liner  140  illustrated in  FIGS. 14-18 , may increase the effectiveness of the valve storage container. Lid liner  140  may be press fit into the lid of a jar like jar  19  and is removed from the jar when the lid is removed. When the lid is attached to the jar, cylindrical boss  142  extends from the lid liner into the jar and reduces the volume of storage solution in the jar. Due to these two factors, the fluid level in the jar is reduced to well below the rim of the jar when the lid is removed, greatly reducing the possibility of spilling storage solution in the operating room.  
         [0066]     Lid liner  140  may be used to vertically secure a valve/holder/support assembly in a jar and prevent damage during shipping. Cylindrical boss  142  of lid liner  140  may be hollowed out so that it is able to flex and secure valve/holder/support assemblies of varying heights. Hollow region  160  is shown in  FIG. 16 .  FIGS. 14-18  show the details of a lid liner in accordance with the principles of the present invention.  
         [0067]      FIGS. 19-33  illustrate the details of various embodiments of a heart valve support in accordance with the principles of the present invention. Specifically,  FIGS. 19-23  show features of an aortic valve support,  FIGS. 24-28  show features of a mitral valve support, and  FIGS. 29-33  show features of a supra valve support. The support may be flexible so that one support can accommodate the entire size range for each type of heart valve, eliminating the need for supports of different sizes.  
         [0068]      FIG. 19  shows aortic valve support  190 . Aortic valve support  190  may have struts  192 , grips  194 , ring  196 , and finger tabs  200  (see  FIG. 20 ). Grips  194  may have torsional ridges  210  (see  FIG. 21 ) that have been designed to fit within small grooves in the sewing cuff fabric and are asymmetric to preferentially resist handle tightening. Aortic support  190  engages the sewing cuff of a replacement aortic valve at locations annularly spaced around the valve.  
         [0069]      FIG. 24  illustrates support  240 , which may have special features adapted for supporting a replacement mitral valve. A holder, like valve holder  13  of  FIG. 1 , may engage a replacement mitral valve adjacent the sewing cuff in three areas that are spaced from one another annularly around the valve. Support  240  may engage the sewing cuff at locations that are annularly intercalated with and spaced from the locations at which the holder engages the valve.  
         [0070]     Mitral valve support  240  may have struts  242 , grips  244 , ring  246 , and finger tabs  250  (see  FIG. 25 ). Grips  244  may have torsional ridges  260  (see  FIG. 26 ) that have been designed to fit within small grooves in the sewing cuff fabric and are asymmetric to preferentially resist handle tightening. Mitral support  240  engages the sewing cuff of a replacement mitral valve at locations annularly spaced around the valve.  
         [0071]      FIG. 29  shows support  290  for engaging a supra replacement heart valve. Supra support  290  engages the sewing cuff of a replacement supra valve at locations annularly spaced around the valve, and may have struts  292 , grips  294 , ring  296 , and finger tabs  300  (see  FIG. 30 ). Grips  294  may have torsional ridges  310  (see  FIG. 31 ) that have been designed to preferentially resist handle tightening.  
         [0072]     As seen in  FIGS. 19-33 , various features of the struts, grips, rings, and tabs may be modified to support the various types of replacement heart valves. However, the basic structural principles of these support structures remain consistent in accordance with the principles of the present invention.  
         [0073]     It will be understood that the foregoing is only illustrative of the principles of the invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, the order of some steps in the procedures that have been described are not critical and can be changed if desired. Also, various steps may be performed with various techniques.