Abstract:
An annuloplasty ring holder is provided for holding an annuloplasty ring during storage and implantation. The annuloplasty ring holder includes a fixed jaw and one or more movable jaws. The movable jaw is coupled to the fixed jaw by a hinge or other means so that an annuloplasty ring may be positioned between the jaws and clamped in place. The holder is selectively coupled to a handle. The holder may be used for all types of annuloplasty rings, including full and partial rings, rigid and flexible rings, and adjustable and non-adjustable rings.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    The present invention relates to surgical tools, namely, an apparatus for holding an annuloplasty ring during storage and implantation.  
           [0002]    Annuloplasty rings are useful in various surgical procedures. An annuloplasty ring may be used to restore or improve the operation of a heart valve by reshaping the heart valve annulus, e.g., mitral or tricuspid annular reduction. In these types of procedures, an annuloplasty ring is positioned about a valve annulus. Sutures are passed through the valve annulus tissue and the annuloplasty ring. The sutures are tightened to hold the annuloplasty ring in a desired position about the annulus, thereby reshaping the annulus.  
           [0003]    Depending on the condition of the valve annulus and the desired reshaping of the valve annulus, different types of annuloplasty rings may be used. An annuloplasty ring may be generally rigid or flexible, full or partial, and adjustable or non-adjustable. In working with any of these types of annuloplasty rings, a surgeon needs a mechanism to securely hold the annuloplasty ring in position while the surgeon places sutures in the ring. Any such mechanism should provide the surgeon with good visual and manual access to the annulus area for proper suturing.  
           [0004]    One approach for holding an annuloplasty ring includes positioning the ring in a groove of a holder, see, e.g., U.S. Pat. No. 5,350,420, incorporated herein by reference. In this approach, the annuloplasty ring is positioned in the groove and held in place by sutures internal to the annuloplasty ring. In the case of a full annuloplasty ring, the ring must be stretched over the groove lip to be positioned in the groove. Such stretching may damage the ring. Also, an annuloplasty ring is typically coupled with its holder during the manufacturing process. Therefore, the ring and holder may be in storage for many months or even years. The sutures used to hold the ring in the groove must be biocompatible and are typically made from polyester or PTFE. Also, the sutures are under constant tension. Over time, these types of sutures may stretch or “creep”. At some point, these sutures may no longer securely hold the ring in the holder groove.  
           [0005]    In another approach for holding an annuloplasty ring, a ring is positioned internal to a series of fingers extending radially from a central base, see, e.g., U.S. Pat. No. 5,011,481, incorporated herein by reference. The ring is he sutures passing through the ring. Again, the sutures used to hold the ring may stretch over time, and may no longer securely hold the ring adjacent the fingers. Therefore, there is a need for an annuloplasty ring holder that will securely hold the ring for a prolonged period of time.  
           [0006]    As described above, an annuloplasty ring is sutured to a valve annulus during implantation. With adjustable rings, the adjustment mechanism, e.g., one or more draw strings, is internal to the ring. Therefore, the surgeon cannot see the internal adjustment mechanism. However, it is crucial that the attaching sutures are not tangled with the ring-adjustment mechanism to ensure that the adjustment mechanism properly functions. Consequently, there is a need for a ring holder that protects the adjustment mechanism during the suturing process.  
         SUMMARY OF THE INVENTION  
         [0007]    The present invention is directed toward a holder for annuloplasty rings. The holder includes a fixed jaw member and a movable jaw member. The jaw members are operably coupled so that the movable jaw member is selectively movable relative to the fixed jaw member. In one embodiment, the coupling mechanism includes a pin extending into both the fixed jaw member and movable jaw member, forming a hinge. Means are provided for selectively actuating the movement of the movable jaw member relative to the fixed jaw member. Additionally, a locking mechanism is provided for selectively locking the position of the movable jaw member relative to the fixed jaw member.  
           [0008]    A handle is selectively coupled with the fixed jaw member. In one embodiment, the handle is axially aligned with the jaw members. In another embodiment, the handle is radially aligned with the jaw members.  
           [0009]    In one embodiment, the fixed jaw member includes a base and a peripheral edge spaced radially outward from the base. In another embodiment, the fixed jaw member includes a base and a plurality of fingers extending radially outward from the base. In another embodiment, the movable jaw member includes a plurality of fingers.  
           [0010]    The present invention provides several advantages. First, it provides a holder with good visual and manual access to the implantation area. Also, the clamping mechanism securely holds the ring for an extended period of time without stretching the ring or suturing the ring to a holder. Also, the clamping mechanism provides quick and easy release of the ring. In the case of adjustable rings, the clamping mechanism serves to protect the adjustment mechanism internal to the ring. Finally, the present invention is useful for many types of annuloplasty rings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    [0011]FIG. 1 is a side view of one embodiment of an annuloplasty ring holder;  
         [0012]    [0012]FIG. 2 is a side view of another embodiment of an annuloplasty ring holder;  
         [0013]    [0013]FIG. 3 is a top view of the embodiment of FIG. 2;  
         [0014]    [0014]FIG. 4 is a side view of another embodiment of an annuloplasty ring holder;  
         [0015]    [0015]FIG. 4 a  is a side view of another embodiment of an annuloplasty ring holder;  
         [0016]    [0016]FIG. 4 b  is a front view of another embodiment of an annuloplasty ring holder;  
         [0017]    [0017]FIG. 5 is a top view of another embodiment of an annuloplasty ring holder; and  
         [0018]    [0018]FIG. 5 a  is a side view of the embodiment of FIG. 5. 
     
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS  
       [0019]    One embodiment of the invention is shown in FIG. 1. This embodiment is particularly useful for holding partial annuloplasty rings. Ring holder  2  includes fixed jaw member  4  and movable jaw member  6 . Movable jaw member  6  is connected with fixed jaw member  4  by pin  8 , forming a hinge, which allows movable jaw member  6  to pivot about pin  8 . Other coupling mechanisms may also be used which allow movable jaw member  6  to move relative to fixed jaw member  4 .  
         [0020]    Fixed jaw member  4  includes a first, clamp end  10  and a second end  12 . A clamp tooth or lip  14  extends generally orthogonal from first end  10 . Second end  12  includes a receiving mechanism  15  for selectively receiving a handle  16  or other device useful for positioning holder  2 . As shown in the embodiment of FIG. 1, handle  16  extends radially along the major axis of holder  2 . In one embodiment, receiving mechanism  15  includes a threaded bore positioned in second end  12  (as shown in FIG. 1) which receives a threaded end of handle  16 . Other coupling mechanisms may also be used.  
         [0021]    Movable jaw member  6  also includes a first, clamp end  18 . A clamp tooth or lip  20  extends generally orthogonal from first end  18  and toward clamp tooth  14 . Movable jaw member further includes first arm section  22  and second arm section  24 , where second arm section  24  deflects from first arm section  22  by angle A. The length of arm sections  22 ,  24  and the size of angle A are selected so that first end  18  moves in a smooth arcuate motion relative to first end  10  and so that tooth  20  is generally aligned with tooth  14  when first end  18  is moved toward first end  10 .  
         [0022]    Movable jaw member  6  further includes a second end  28  coupled to second arm section  24 . Second end  28  of movable jaw member  6  includes coupling member  30  for selectively coupling movable jaw member  6  in a fixed position relative to fixed jaw member  4 . As shown in the embodiment of FIG. 1, coupling member  30  extends generally orthogonal from second arm section  24  and toward fixed jaw member  4 . In one embodiment, fixed jaw member  4  includes a bore for receiving coupling member  30 . In another embodiment, coupling member  30  includes one or more raised surfaces, which slide over raised surfaces on fixed jaw member  4  and lock movable jaw member  6  in place. Other types of coupling mechanisms may also be used to selectively lock movable jaw member  6  in a fixed position relative to fixed jaw member  4 .  
         [0023]    As shown in FIG. 1, an annuloplasty ring  32  is positioned between teeth  14  and  20 . By moving the second end  28  of movable jaw member  6  toward fixed jaw member  4 , teeth  14  and  20  pinch or clamp down on ring  32 , securely holding ring  32  to holder  2 . In the case of an adjustable ring, the teeth  14 ,  20  are positioned so that a suture portion of the ring is exposed for suturing to the valve annulus, while the adjustment mechanism is protected from the suturing process.  
         [0024]    Another embodiment of the invention is shown in FIG. 2. The clamping mechanism is similar to that shown in FIG. 1, however, handle  36  is positioned axially relative to the clamping mechanism, as opposed to the radial alignment of FIG. 1. The axial alignment of the handle is useful for holders that can be used with both full and partial rings.  
         [0025]    Ring holder  40  includes fixed jaw member  42  coupled with one or more movable jaw members  44 . In the embodiment of FIG. 2, two movable jaw members  44  are provided. In other embodiments, three or more movable jaw members  44  are provided. Such a configuration may be particularly useful with annuloplasty rings that are rigid for more than 180 degrees. Movable jaw members  44  are coupled with fixed jaw member  42  by pins  45 , forming a hinge as described above. Other coupling mechanisms may also be used which allow selective movement of movable jaw members  44  relative to fixed jaw member  42 .  
         [0026]    Fixed jaw member  42  includes a central base  46  and radially spaced, peripheral edge  48 . Clamp tooth  50  extends generally orthogonal from clamp edge  48 . In the embodiment of FIG. 3, peripheral edge  48  is generally in the shape of a AD@, i.e., the general shape of a typical full mitral annuloplasty ring. In other embodiments, the holder may be of a shape suitable for the specific application, e.g., more round or oval shaped.  
         [0027]    Referring again to FIG. 2, movable jaw members  44  include first clamp ends  52  and second ends  53 . Clamp teeth  54  extend generally orthogonal from clamp ends  52  and toward clamp tooth  50 . Movable jaw members  44  further include first arm sections  56  and second arm sections  58 , where second arm sections  58  deflect from first arm sections  56  by angle B. The length of arm sections  56 ,  58  and the size of angle B are selected so that first ends  52  move in a smooth arcuate motion relative to edge  48  and so that teeth  54  are generally aligned with tooth  50  when first ends  52  are moved toward edge  48 .  
         [0028]    Jaw actuating mechanism  60  is coupled with base  46 . In the embodiment of FIG. 2, jaw actuating mechanism  60  includes threaded nut  62  positioned on threaded mount  64 . Nut  62  includes camming surfaces  66 . Second ends  53  of movable jaw members  44  include first camming surfaces  68  and second camming surfaces  70 . By rotating nut  62  in a first direction, nut  62  moves toward base  46  and camming surfaces  66  contact first camming surfaces  68 , thereby forcing second ends  53  toward base  46  and first ends  52  toward edge  48 . This provides a secure clamp of an annuloplasty ring  72  between tooth  50  and teeth  54 , as shown in FIG. 2. Consequently, nut  62  also serves as a locking mechanism to hold ring  72  in place.  
         [0029]    As in the embodiment of FIG. 1, an adjustable ring may be positioned between tooth  50  and teeth  54  so that the adjustment mechanism internal to ring  72  is protected from suturing.  
         [0030]    By rotating nut  62  in the opposite direction, camming surfaces  66  move away from first camming surfaces  68  and teeth  54  move away from tooth  50 , thereby releasing ring  72 . Again, this clamping mechanism will hold an annuloplasty ring for a long period of time without stretching or otherwise degrading the strength of the attachment to holder  40 . Other jaw actuating mechanisms may also be used.  
         [0031]    Another embodiment of the invention is shown in FIGS. 4, 4 a  and  4   b . This embodiment is similar to FIG. 2; however, pins  74  are positioned centrally on base  46 . The jaw can be held in place by a loop of suture that would be cut by the implanting surgeon. Alternatively, as shown in FIG. 4 a , a cantilevered tab  100  attached to the distal jaw  101  could protrude through a rectangular hole  102  in the proximal jaw  103 , engaging the proximal jaw with a tab  104  that can be released by the surgeon applying finger pressure P to the cantilevered tab  100 .  
         [0032]    Another embodiment of the invention is shown in FIGS. 5 and 5 a . In this embodiment, four fingers  80  extend from base  82  to form a fixed jaw member. A movable jaw member (not shown) includes four fingers generally aligned with fingers  80 . As described above, the movable jaw member fingers are selectively movable relative to the fixed jaw member fingers, providing a clamping mechanism to securely hold an annuloplasty ring. Other embodiments of the invention may include more or fewer fingers for both the fixed and movable jaw members.  
         [0033]    Other embodiments are within the scope of the following claims.