Abstract:
An improved method of connecting body tissue to a bone in a body. The method includes utilizing an anchor with a conical leading end, a trailing end, a central longitudinal axis passing through the leading and trailing ends, at least two suture passages extending through the anchor transverse to the central longitudinal axis, and a length. The leading end of the anchor has a maximum dimension transverse to the central longitudinal axis that is less than a maximum dimension of the trailing end transverse to the central longitudinal axis. The anchor includes at least one of the suture passages having a portion of a suture positioned therein. The method includes advancing the anchor to insert the leading end of the anchor first through an aperture in a cortical layer of the bone to place the entire anchor within cancellous tissue of the bone, wherein the length of the anchor is greater than a width of the aperture. The method also includes applying a force to the anchor by pulling on the suture to rotate the anchor within the cancellous tissue of the bone to prevent the anchor from passing back through the aperture in the cortical layer of the bone. The method also includes attaching the suture to the body tissue to be connected to the bone.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 10/614,352 filed Jul. 7, 2003; which is a continuation of U.S. patent application Ser. No. 09/556,458 filed May 3, 2000 (now U.S. Pat. No. 6,592,609), which is a continuation-in-part of: U.S. patent application Ser. No. 09/524,397 filed Mar. 13, 2000 (now U.S. Pat. No. 6,368,343); U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 (now U.S. Pat. No. 6,475,230); and U.S. patent application Ser. No. 09/370,865 filed Aug. 9, 1999 (now U.S. Pat. No. 6,447,516). The benefit of the earlier filing dates of the aforementioned applications is hereby claimed for all subject matter common to this application and any one of the aforementioned applications. The disclosures in the aforementioned applications are hereby incorporated herein in their entirety by this reference thereto. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a new and improved method and apparatus for securing tissue in a patient&#39;s body. The method and apparatus may be utilized to secure hard tissue and/or soft tissue in a patient&#39;s body. 
       BACKGROUND OF THE INVENTION 
       [0003]    Anchors have previously been utilized to retain sutures in a patient&#39;s body. The anchors have previously been formed of metal, such as stainless steel or titanium. In addition, anchors have been formed of biodegradable materials. Anchors have also been formed of bone. It has previously been suggested to construct anchors in the manner disclosed in U.S. Pat. Nos. 5,527,343; 5,534,012; 5,928,267; and 5,989,282. The disclosures in the aforementioned patents are hereby incorporated herein in their entirety by this reference thereto. 
         [0004]    It has previously been suggested that ultrasonic vibratory energy be utilized to interconnect sections of a suture in the manner disclosed in U.S. Pat. No. 3,513,848. This patent suggests that the suture is initially tensioned by a surgeon or his assistant by gripping free ends of the suture and applying the requisite force. While the requisite force is maintained, ultrasonic energy is applied to the segments of the suture. The high frequency mechanical vibrations applied to the suture result in bonding of overlapping areas on segments of the suture. It has also been suggested that ultrasonic energy could be utilized in connecting an elongated element with a fusible receptacle in the manner disclosed in U.S. Pat. No. 5,964,765. 
         [0005]    When tissue is to be secured against movement relative to a portion of a bone, it is necessary to interconnect the bone and the tissue. In this situation, it has been a common practice to drill a hole which extends into or through the bone. A retaining member, such as a pin, screw or suture anchor is positioned in the hole after it has been drilled in the bone. The concept of utilizing a retainer member formed of bone to anchor a suture is disclosed in U.S. Pat. No. 5,626,612. It has also been suggested that screws, pins, anchors and plates could be fabricated from bone in the manner disclosed in U.S. Pat. No. 5,968,047. 
       SUMMARY OF THE INVENTION  
       [0006]    The present invention relates to a method and apparatus for use in securing soft tissue, hard tissue, or hard and soft tissue in a patient&#39;s body. The hard tissue may be any one of the many bones in a patient&#39;s body. The soft tissue may be any one of the tissue in a patient&#39;s body other than the hard tissue. 
         [0007]    The tissue may be secured by using a suture. The suture may be connected with an anchor. When an anchor is utilized in association with a suture, the anchor may be formed of any one of many different materials including bone or other body tissue, biodegradable materials, or non-biodegradable materials. The anchor may be formed of two or more different materials. 
         [0008]    When a suture is utilized to secure body tissue, a retainer may be connected with the suture. Alternatively, sections of the suture may be connected with each other. 
         [0009]    If a suture is utilized to secure body tissue, an apparatus may advantageously be provided to tension the suture with a predetermined force. If a retainer is utilized in association with the suture, the apparatus may urge the retainer toward the body tissue with a predetermined force. The retainer may be connected with the suture in response to detection of at least a predetermined tension in the suture and/or the transmission of a predetermined force to the body tissue. When the retainer is to be eliminated, sections of the suture may be interconnected in response to detection of a predetermined tension in the suture and/or detection of the transmission of a predetermined force to the body tissue. 
         [0010]    The anchor, for some uses at least, may be formed of a single piece of bone. A pointed end portion of the anchor may have a surface which forms an opening in a bone or other tissue in a patient&#39;s body. The anchor may be moved into the opening formed in the tissue by the pointed leading end portion of the anchor. 
         [0011]    It should be understood that in certain situations, it may be desired to use just a suture, without an anchor, to secure the body tissue. In these situations, a retainer may be connected with the suture. Alternatively, sections of the suture may be directly connected with each other. In other situations, it may be desired to use an anchor, without a suture, to secure body tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0012]    A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein: 
           [0013]      FIG. 1  is an enlarged plan view of an anchor which may be utilized in securing body tissue; 
           [0014]      FIG. 2  is a side elevational view, taken generally along the line  2 - 2  of  FIG. 1 , further illustrating the construction of the anchor; 
           [0015]      FIG. 3  is a fragmentary schematic illustration depicting, on a reduced scale, one of the ways in which the anchor of  FIGS. 1 and 2  may be positioned relative to hard and soft body tissue; 
           [0016]      FIG. 4  is a schematic fragmentary illustrating depicting one way in which the anchor of  FIG. 3  may connected with body tissue utilizing a retainer connected with a suture; 
           [0017]      FIG. 5  is a fragmentary schematic sectional view, generally similar to  FIG. 4 , illustrating how one section of a suture is connected with an anchor embedded in cancellous bone and extends through soft tissue while another section of the suture is positioned to extend around the soft tissue; 
           [0018]      FIG. 6  is a fragmentary schematic illustration depicting the manner in which the suture of  FIG. 5  is tensioned with a predetermined force and a connector assembly is utilized no press soft tissue against the bone prior to utilization of the assembly to interconnect sections of the suture; 
           [0019]      FIG. 7  is a schematic illustration depicting the manner in which the anchor of  FIGS. 1 and 2  is positioned relative to layers of soft body tissue prior to securing of the layers of soft body tissue with a suture connected to the anchor; 
           [0020]      FIG. 8  is a schematic sectional view, generally similar to  FIG. 7 , illustrating the manner in which the anchor and suture cooperate with a retainer to secure the layers of soft body tissue; 
           [0021]      FIG. 9  is a schematic sectional view illustrating the manner in which the anchor and suture of  FIG. 7  are utilized to interconnect layers of soft body tissue and the manner in which sections of the suture connected with the anchor are interconnected utilizing ultrasonic vibratory energy; 
           [0022]      FIG. 10  is a schematic pictorial illustration of an apparatus for use in tensioning a suture with a predetermined tension, applying a predetermined force against a retainer, and connecting the retainer with the suture; 
           [0023]      FIG. 11  is a highly schematicized illustration depicting the manner in which the apparatus of  FIG. 10  is utilized to tension a suture with a predetermined force, apply a predetermined force against a retainer, and connect the retainer with the suture; and 
           [0024]      FIG. 12  is a highly schematicized illustration of a second embodiment of the apparatus of  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Anchor 
       [0025]    One specific anchor  20  constructed in accordance with the present invention is illustrated in  FIGS. 1 and 2 . The anchor  20  may be utilized to secure a suture relative to body tissue in a patient&#39;s body. However, it is contemplated that, in some situations at least, the anchor  20  may be utilized without a suture. 
         [0026]    The anchor  20  is formed of a single piece of bone, specifically, hard compact bone (cortical bone). The bone form which the member  20  is formed may be autogenic bone or allogenic bone. Alternatively, the anchor  20  may be formed of xenogenic bone. 
         [0027]    Although the anchor  20  may be formed of bone obtained from many different sources, it is believed that it may be preferred to form the anchor  20  of freeze dried bone which has been obtained from a human cadaver. The bone may be harvested under clean conditions and treated to achieve sterility. Of course, the bone forming the anchor  20  could be obtained in any one of many different manners under any one of many different conditions. 
         [0028]    Although it is preferred to form the anchor  20  of bone, the anchor may be formed of other materials if desired. The anchor  20  many be formed of biodegradable or non-biodegradable materials. For example, the anchor  20  may be formed of polycaperlactone. The anchor  20  may be formed of metal, such as titanium or stainless steel. Alternatively, the anchor  20  may be formed of biodegradable or bioerodible copolymers. 
         [0029]    The anchor  20  is formed of a signal piece of bone and includes a cylindrical body portion  22  and a pointed end portion  24 . The pointed end portion  24  has a conical configuration. The cylindrical body portion  22  and pointed end portion  24  have a common longitudinal central axis  28  which extends axially through the anchor  20 . 
         [0030]    Although the pointed end portion  24  has a conical configuration, the pointed end portion could have a different configuration if desired. For example, the pointed end portion could be wedge-shaped. Alternatively, the pointed end portion  24  could have a pyramidal configuration and be formed by the intersection of three, four, or more surfaces. The surfaces could be flat or concave in configuration. 
         [0031]    It is contemplated that the anchor  20  may be used in association with a suture. If and when the anchor  20  is to be used with a suture, the anchor is provided with a pair of passages  30  and  32 . The passages  30  and  32  have a cylindrical configuration and extend diametrically through the cylindrical body portion  22 . Central axes of the passages  30  and  32  extend parallel to each other and intersect the central axis  28  of the anchor  20 . 
         [0032]    The passage  30  is formed entirely in the body section  22 . However, the passage  32  is formed partially in the body section  22  and partially in the pointed end portion  34 . Thus, the major portion of the passage  32  is formed in the body portion  22 . However, a minor portion of the passage  32  extends into the pointed end portion  24 . 
         [0033]    In the illustrated embodiment of the anchor  20 , two passages  30  and  32  extend diametrically through the cylindrical body portion  22  of the anchor. However, it is contemplated that only a single passage may be provided through the anchor. This single passage could be skewed at an acute angle relative to the central axis  28  of the anchor  20 . Alternatively, the passage could extend axially through the anchor. 
         [0034]    Although it is preferred to provide the anchor  20  with the pointed leading end portion  24 , it is contemplated that the anchor  20  could have a different configuration. For example, the anchor  20  could have the configuration of any one of the anchors illustrated in U.S. Pat. No. 5,527,343, or U.S. Pat. No. 5,534,012. The disclosures in the aforementioned U.S. Pat. Nos. 5,534,012, and 5,527,343 have been and hereby are incorporated herein in their entirety. 
         [0035]    In on specific embodiment of the anchor  20 , intended for use with a suture, the anchor had an overall length of approximately 0.236 inches and a body portion  22  with a diameter of approximately 0.072 inches. The passages  30  and  32  had diameters of approximately 0.035 inches. Another embodiment of the anchor  20  had an overall length of approximately 0.354 inches and a body portion  22  with a diameter approximately 0.119 inches. The passages  30  and  32  in the specific anchor had a diameter of approximately 0.046 inches. 
         [0036]    It should be understood that the foregoing dimensions of specific embodiments of the anchor  20  have been set forth herein for purposes of clarity of description. It is contemplated that the anchor  20  will be formed with dimensions which are different than these specific dimensions. For example, and anchor  20  intended for use without a suture may have a length which is different than the specific lengths previously set forth herein. Similarly, anchors intended for use with soft body tissue may have dimensions which are different than dimensions of anchors intended for use with hard body tissue. 
         [0037]    The specific embodiment of the anchor  20  described herein is formed of bone. Specifically, the anchor  20  is formed of a single piece of human bone. However, the anchor  20  may be formed of other materials if desired. For example, the anchor  20  may be formed of titanium or titanium alloys. Alternatively, the anchor  20  may be formed of stainless steel. The anchor  20  may be formed of any one of many known biodegradable materials. The anchor  20  may be formed of either biodegradable or nonbiodegradable polymeric materials. 
       Positioning of Anchor  
     Relative to Body Tissue 
       [0038]    The anchor  20  of  FIGS. 1 and 2  may be utilized to secure a suture  36  ( FIG. 3 ) relative to body tissue. The suture  36  may be formed of a plastic material which is a biopolymer. In one specific embodiment of the invention, the suture  36  is formed of polyglycolide which is commercially available under the trademark DEXON. Polyglycolide is a crystalline material that melts at about 225° Celsius. Although the suture  36  is a monofilament suture having a continuous cylindrical outer side surface, it is contemplated that the suture could be formed in a different manner. For example, the suture  36  cold be a cable having an interlaced structure formed by a plurality of filaments or strands which have been twisted, braided, twined, and/or threaded together. 
         [0039]    It is also contemplated that the suture  36  may be formed of a polyglycolide-based copolymer, specifically, 10/90 P-LL/G (10% poly l-lactide and 90% glycolide) which is commercially available under the trademark VICRYL, VICRYL is a crystalline material that melts at about 205° Celsius. VICRYL can be used for either a monofilament or a braided suture. The suture  36  may have a construction which is similar to the construction of the sutures disclosed in U.S. Pat. No. 5,928,267. The aforementioned U.S. Pat. No. 5,928,267 has been and hereby is incorporated herein in its entirety. 
         [0040]    The strength of the suture  36  will vary as a function for the size of the suture. It is contemplated that the specific strength of a particular suture size will vary depending upon the material from which the suture is constructed and the manufacturer of the suture. By consulting a chart, a surgeon can select a suture of a size and strength suitable for a particular use. Thus, a relatively large suture having substantial strength may be selected when body tissue is to be connected with a bone or when portions of a bone are to be interconnected by the suture. On the other hand, a relatively small suture size having a relatively small strength may be selected when delicate body tissue, such as stomach or intestinal tissue is to be interconnected with the suture. 
         [0041]    The manner in which the suture size and strength varies is explained in the aforementioned U.S. patent application Ser. No. 09/523,442, filed Mar. 10, 2000 and entitled “Method and Apparatus for Securing a Suture”. The disclosure in the aforementioned U.S. patent application Ser. No. 09/523,442 has been and hereby is incorporated herein in its entirety. 
         [0042]    In the embodiment of the invention illustrated in  FIG. 3 , the anchor  20  is utilized with a suture  36 . The specific anchor  20  illustrated in  FIG. 3  is integrally formed as one piece of freeze dried human bone. The anchor  20  and suture  30  are utilized to hold soft body tissue  40  against movement relative to a portion of a bone  44  in a human patient&#39;s body. The tissue  40  is connective tissue, such as a ligament or tendon. However, the tissue  40  could be other types of tissue if desired. 
         [0043]    When the tissue  40  is to be connected with the bone  44 , the anchor  20  is utilized to initiate the formation of an opening in the bone at a location which is free of naturally occurring openings. Prior to formation of an opening in the bone  44  with the anchor  20 , a hard outer surface  48  is removed from a compact outer layer  50  of bone by a decortation process. The decortation process is performed by abrading the hard outer surface  48  on the compact outer layer  50  of hard cortical bone to expose an imperforate inner area  52  at a location where the anchor  20  and suture  36  are to be utilized to connect the body tissue  40  with the bone  44 . Once the decortation process has been completed, the soft body tissue  40  is positioned in engagement with the inner area  52  in the manner illustrated schematically in  FIG. 3 . The decortation process is optional and may be omitted if desired. 
         [0044]    The anchor  20  is then moved through the body tissue  40  into the bone  44 . It is believed that it will be preferred to move the anchor  20  into the bone  44  under the influence of an axial force applied against a trailing end portion of the anchor. Since the bone forming the anchor  20  has a relatively high compressive strength, the anchor can be utilized to transmit relatively large forces along the longitudinal central axis  28  ( FIG. 1 ) of the anchor to force the anchor into the bone  44 . However, bone has a relatively low tensile strength and can not transmit large transverse loads. Therefore, when the anchor  20  is moved into the bone  44  under the influence of axial force applied against trailing end of the anchor, there may be a tendency for the anchor to shear or fail by a lateral buckling or fracture of the anchor rather than by direct compression of the anchor. 
         [0045]    In order to support the anchor  20  during movement of the anchor into the bone  44 , the anchor is advantageously inserted into a tubular cylindrical metal sleeve or member  58  ( FIG. 3 ). A cylindrical pusher member  60  is received in the cylindrical sleeve  58  and is utilized to apply an axial force to a circular trailing end surface  62  on the anchor  20 . Although the sleeve and pusher member  58  and  60  could have many different configurations and cooperate with each other in many different manners, it may be preferred to utilize a sleeve  58  and pusher member  60  having a construction similar to the construction illustrated in U.S. Pat. No. 5,948,002. The disclosure in the aforementioned U.S. Pat. No. 5,948,002 is hereby incorporated herein in its entirety by this reference thereto. Of course, different types of devices could be utilized to move the anchor  20  into the body tissue  40  and bone  44  if desired. 
         [0046]    When the anchor is to be moved through the body tissue  40  into the bone  44 , the pointed end portion  24  of the anchor is aligned with the body tissue  40  at a location where the anchor is to be moved into the body tissue. The sleeve  58  is then pressed firmly against the body tissue  40 . Although a substantial space has been sown between the inner surface of the sleeve  58  and the cylindrical outer side surface of the anchor  20  in  FIG. 3  for purposed of clarity of illustration, it is contemplated that there will be a relatively snug fit of the anchor  20  and pusher member  60  with the inner side surface of the sleeve  58 . However, the anchor  20  and pusher member  60  will be freely movable in an axial direction along the sleeve  58 . 
         [0047]    The pusher member  60  is then pressed firmly against the trailing surface  62  on the anchor  20 . This force easily moves the pointed leading end portion  24  of the anchor  20  through the soft body tissue  40  into engagement with an imperforate surface area on the compact outer layer  50  of the bone  44 . 
         [0048]    The anchor  20  is moved out of the tubular sleeve  58  into the compact outer layer  50  of the bone  44  at a location which is free of naturally occurring openings ( FIG. 3 ). To move the anchor  20  out of the sleeve  58  into the bone  44 , the pusher member applies an axial force against the trailing end surface  62  on the anchor  20 . The axial force applied by the pusher member  60  moves the pointed leading end portion  24  of the anchor into the compact outer layer  50  of bone. The tubular sleeve  58  engages the cylindrical outer side surface of the anchor  20  to support the anchor against sidewise loading. The results in the anchor being subjected primarily to compressive force as the anchor is moved into the bone  44 . 
         [0049]    As the anchor  20  moves into the bone  44 , the material of the compact outer layer  50  of the bone is displaced sideways by the leading end portion  24  of the anchor  20 . As the anchor  20  continues to move into the compact outer layer  50  of the bone  44 , the material of the compact outer layer supports the anchor against transverse loading in much the same manner in which the tubular sleeve  58  supports the anchor. Therefore, the pusher member  60  can apply relatively large axial force to the anchor  20  without failure, that is, without fracture or buckling of the anchor. 
         [0050]    The anchor  20  is utilized to initiate formation of an opening in the compact outer layer  50  of the bone  44  at a location which is free of openings. However, if desired, a relatively small pilot opening could be drilled through the compact outer layer  50  of the bone  44 . The anchor  20  would then be utilized to form the small pilot opening into a large opening through which the anchor can pass. 
         [0051]    The anchor  20  is moved through a desired distance into the bone  44 . In order to facilitate determination of when the anchor  20  is moved through the desired distance into the bone  44 , indicia may be provided on the pusher member  20 . The indicia on the pusher member  60  cooperates with the sleeve  58  to indicate when the anchor  20  has moved through a desired distance into the bone  44 . The application of force against the anchor  20  by the pusher member  36  is then interrupted. The manner in which the sleeve  58  and pusher member  60  cooperate with the anchor  20  is the same as disclosed in U.S. patent application Ser. No. 09/370,865 filed Aug. 9, 1999 by Peter M. Bonutti and entitled “Method of Securing Tissue”. The disclosure in the aforementioned U.S. patent application Ser. No. 09/370,865 has been hereby is incorporated herein in its entirety. 
         [0052]    It is contemplated that the anchor  20  may be utilized, without the suture  36 , to connect the body tissue  40  with the bone  44 . When that anchor  20  is to be used in the manner, the anchor  20  will engage both the body tissue  40  and the bone  44 . However, the illustrated embodiment of the anchor  20  is intended for use with the suture  36 . 
         [0053]    The pusher member  60  is effective to push the anchor  20  through the compact outer layer  50  of hard cortical bone into relatively soft cancellous bone  66  which is enclosed by the hard compact outer layer  50 . As the pointed leading end portion  24  of the anchor  20  enters the cancellous bone  66 , the ;pointed end portion pushes the cancellous bone  66  aside to form an opening in the cancellous bone. The anchor moves into the cancellous bone  66  along a straight path having a longitudinal axis which is coincident with a longitudinal central axis of the sleeve  58 . Therefore, the pointed end portion  24  of the anchor is effective to push aside tissue forming the compact outer layer  50  and the cancellous bone  66  as the anchor moves into the bone  44 . 
         [0054]    When the anchor has moved through a predetermined distance into the cancellous bone  66 , the anchor is pivoted from the orientation illustrated in  FIG. 3  to the orientation illustrated in  FIG. 4 . Thus, after the end surface  62  on the anchor  20  has moved past the inner side surface of the compact outer layer  50  and into the cancellous bone  66 , the orientation of the anchor  20  relative to the bone  44  is changed by rotating the anchor through ninety degrees (90°) with a toggling action. 
         [0055]    The initiate the toggling action, a section  70  of the suture  36  extending through the anchor passage  32  to a location outside of the bone is tensioned. At this time, a second section  72 , which extends through the anchor passage  30 , is relaxed. There is enough friction between the section  70  of the suture and the freeze-dried bone forming the anchor  20  to initiate a pivoting action of the anchor. 
         [0056]    Once this pivoting action has been initiated, the pusher member  60  ( FIG. 3 ) is pressed against a circular rim on the end surface  62  and the tension in the section  70  of the suture is increased. As the tension in the section  70  of the suture is increased, the suture tends to slide relative to the material forming the anchor  20 . Therefore, the tension in the section  72  of the suture  36  is increased. However, the tension in the section  70  of the suture will tend to be large than the tension in the section  72  of the suture. 
         [0057]    Once the anchor  20  begins to rotate with a toggling action, the pusher member  60  is pressed against the rim of the end surface  62  to maintain the anchor at the desired depth in the cancellous bone  66 . At the same time, the tension in the sections  70  and  72  of the suture  36  applies torque to the anchor to rotate the anchor about the location where the anchor engages the pusher member  60 . The anchor  20  rotates with a toggling action in the manner disclosed in the aforementioned U.S. Pat. Nos. 5,527,343; 5,534,012; and 5,948,002. The aforementioned patents have been and hereby are incorporated herein in their entirety. 
         [0058]    Once the anchor  20  has pivoted to the orientation illustrated in  FIG. 4 , the sections  70  and  72  of the suture  36  can be freely moved in the passages  32  and  30  extending through the anchor. This enables the sections  70  and  72  of the suture  36  to be moved relative to each other so that they have the desired length. 
         [0059]    The anchor  20  is supported in the cancellous bone  66  in a spaced-apart relationship with the compact outer layer  50  of bone. The anchor  20  is entirely surrounded by a matrix of the cancellous bone  66 . The anchor  20  does not touch the compact outer layer  50  of bone. Tension forces applied to the anchor  20  by the suture  36  are transmitted from the outer side surface of the anchor to the cancellous bone to hold the anchor against movement relative to the bone  44 . 
         [0060]    The suture  36  extends through an opening  78  in the compact outer layer  50  of bone into the soft body tissue  40 . The suture extends through the soft body tissue to a location disposed on a side of the soft body tissue opposite from the bone  44 . The suture  36  extends through the body tissue  40  along the same path which the anchor was moved through the body tissue  40  from the position shown in  FIG. 3  to the position shown in  FIG. 4 . The viscoelastic nature of the soft body tissue  40  results in closing of the opening formed in the body tissue  40  by passage of anchor  20  through the body tissue. However, the sections  70  and  72  of the suture remain in the closed passage through the body tissue  40  along which the anchor  20  previously moved. 
         [0061]    The suture  36  may be connected with the soft body tissue in any one of many different ways. In the embodiment of the invention illustrated in  FIG. 4 , a retainer  82  is connected with the sections  70  and  72  of the suture  36 . Although the sections  70  and  72  of the suture  36  could extend straight through the retainer  82 , it is preferred to form a plurality of bends in the suture by wrapping the suture around a portion of the retainer. 
         [0062]    The illustrated retainer  82  has a spherical configuration with a cylindrical passage which extends diametrically through the center of the retainer. The sections  70  and  72  of the suture  36  may be wrapped around the retainer  82  and passed through the passage through the retainer a plurality of times. Thus, the section  70  of the suture  36  extends through the passage in the retainer  82 , around the outer side surface of the retainer and back through the passage again. The section  72  of the suture  36  also extends through the passage in the retainer  82 , around the outside of the retainer and back through the passage in the retainer. If desired, the retainer  82  could have a different configuration and the suture  36  could be connected with the retainer in a different manner if desired. 
         [0063]    After the suture  36  has been inserted through the retainer  82 , the retainer  82  is moved along the sections  70  and  72  of the suture toward the body tissue  40 . As the retainer  82  is moved along the sections  70  and  72  of the suture  36  toward the body tissue  40 , the retainer moves into engagement with the body tissue. The sections  70  and  72  of the suture  36  are then tensioned with a predetermined force. This predetermined tension force is transmitted through the retainer  82  to the anchor  20 . At the same time, the retainer  82  is pressed downward against the body tissue  40  with a predetermined force. 
         [0064]    This results in the soft body tissue  40  being compressed against the inner area  52  on the compact outer layer  50  of bone with a predetermined force while a predetermined tension force is transmitted through the suture  36  to the anchor  20 . In this manner, a desired force, which has been preselected as a function of the size of the suture  36  and the characteristics of the soft body tissue  40  and bone  44  is applied against the body tissue and the bone by the anchor  20  and retainer  82 . Although the retainer  82  applies force against a far greater surface area on the soft body tissue  40  than would be engaged by a knot in the suture  36 , a force distribution member or button may be placed between the retainer  82  and the upper surface of the soft body tissue. 
         [0065]    Once the retainer  82  has been moved along the suture  36  and is being pressed against the soft body tissue  40  with a predetermined force while a predetermined tension is maintained in the sections  70  and  72  of the suture  36 , the suture retainer  82  is connected with the suture  36 . The suture retainer  82  may be connected with the suture  36  in any one of many different ways. However, the retainer  82  is connected with the suture  36  by plastically deforming the retainer to effect a cold flowing of material of the retainer. 
         [0066]    Force is applied against opposite sides of the retainer  82  by a pair of force application members with a clamping action. This force is effective to cause flowing of the material of the retainer  82  at a temperature below a transition temperature range for the material of the retainer. The cold flowing of the material of the retainer  82  results in a collapsing of the passage through the retainer and a flowing of the material of the retainer around the sections  70  and  72  of the suture. This enables the material of the retainer  82  to bond to and obtain a firm grip on the suture  36 . The cold flowing of the material of the retainer  82  occurs at a temperature which is below the transition temperature of the material forming the retainer. 
         [0067]    As the material of the retainer  82  is deformed, the material of the retainer bonds to the suture  36 . When the suture  36  is of the cable type and formed by a plurality of interconnected filaments or strands, the material of the retainer  82  flows around and between the strands. The material of the retainer  82  flows completely around portions of each individual strand and bonds to each individual strand. In addition, the material of the retainer  82  flows around the intertwined suture strands and bonds to them as a group. Of course, if the suture  36  is a monofilament, the material of the retainer bonds to only the single strand or filament. 
         [0068]    The retainer  82  may be formed of many different materials. However, it is believed that it will be preferred to form the retainer  82  of a biodegradable polymer. Once biodegradable polymer which may be utilized is polycaperlactone. Alternately, the retainer  82  could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. It is contemplated that other biodegradable or bioerodible copolymers could be utilized. It is believed that it will be preferred to form the suture  36  of the same material as the retainer  82 . Thus, the suture  36  could be formed of any one of the materials previously suggested for forming the retainer  82 . 
         [0069]    It is preferred to effect the cold flowing of the material of the suture retainer  82  without the addition of heat. However, it is contemplated that the suture retainer  82  could be heated to a temperature which is somewhat above the temperature of the body tissue  40 . If desired, heat could be transmitted to the retainer  82  through force application members which effect plastic deformation of the material of the retainer. When the suture  36  has a plurality of twisted strands, flowing of the material of the retainer  82  around the strands of the suture is promoted by heating of the retainer. 
         [0070]    The construction of the retainer  82  and the manner in which it cooperates with the suture  36  is the same as is disclosed in the aforementioned U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 by Peter M. Bonutti et al. and entitled “Methods and Apparatus for Securing a Suture”. The disclosure in the aforementioned application Ser. No. 09/523,442 has been and hereby is incorporated herein in its entirety. 
         [0071]    Although one specific retainer  82  has been described in connection with the embodiment of the invention illustrated in  FIG. 4 , it is contemplated that the retainer  82  could have a different construction if desired. For example, the retainer  82  could have any one of the constructions disclosed in the aforementioned application Ser. No. 09/523,442. Alternatively, the retainer  82  could have a different known construction. 
       Embodiment of FIGS. 5 and 6 
       [0072]    In the embodiment of the invention illustrated in  FIGS. 1-4 , the sections  70   72  of the suture  36  extend through the body tissue  40  and are connected with a retainer  82 . In the embodiment of the invention illustrated in  FIGS. 5 and 6 , one of the sections of the suture extends through the body tissue while the other section of the suture extends around the outside of the body tissue. In the embodiment of the invention illustrated in  FIGS. 5 and 6 , the retainer is eliminated and the sections of the suture are connected directly to each other. Since the embodiment of the invention illustrated in  FIGS. 5 and 6  is similar to the embodiment of the invention illustrated in  FIGS. 1-4 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiment of the invention illustrated in  FIGS. 1-4  may be used with the embodiment of the invention illustrated in  FIGS. 5 and 6 . 
         [0073]    An anchor  100  has the same construction as the anchor  20  of  FIGS. 1 and 2 . The specific anchor  100  of  FIGS. 5 and 6  is integrally formed as one piece of freeze dried human bone. The anchor  100  is inserted through soft body tissue in the same manner as was previously described in conjunction with the embodiment of the invention illustrated in  FIGS. 3 and 4 . In addition, the anchor  100  was moved through a compact outer layer  104  of a bone  106  into cancellous bone  108  in the same manner as was previously described in connection with  FIGS. 3 and 4 . The anchor  100  is supported in the cancellous bone  108  in a spaced-apart relationship with the companies outer layer  104  of the bone  106 . 
         [0074]    A suture  110  extends through passages in the anchor  100 . The suture  110  may have either a cable-like or a monofilament construction. The suture  110  may be a cable having strands formed of any of the materials mentioned in conjunction with the suture  36  of  FIGS. 3 and 4 . However, the illustrated suture  110  is a monofilament having a continuous cylindrical outer side surface. 
         [0075]    Sections  112  and  114  of the suture  110  are pulled through the soft body tissue  102  and into the bone  106  as the anchor  100  is inserted into the bone in the manner previously explained in conjunction with the embodiment of the invention illustrated in  FIG. 3 . However, in the embodiment of the invention illustrated in  FIGS. 5 and 6 , it is desired to have one of the sections of the suture extend around the outside of the soft body tissue  102  while the other section of the suture extends through the body tissue. Thus, a gripper, illustrated schematically at  118  in  FIG. 5 , grips the section  114  of the suture  110  and pulls the section  114  of the suture out of the soft body tissue  102  after the anchor  100  has been ;positioned in the cancellous bone  108 . Although the section  114  of the suture  110  is withdrawn from the soft body tissue  102 , the section  112  of the suture remains extending through the soft body tissue in the manner illustrated schematically in  FIG. 5 . The section  114  of the suture  110  is wrapped around the outside of the body tissue and pulled into engagement with the section  112  of the suture. 
         [0076]    Once the sections  112  and  114  of the suture  110  have been positioned relative to the body tissue  102 , the sections  112  and  114  of the suture are tensioned with a predetermined force. At the same time, the soft body tissue  102  is pressed against the hard compact outer layer  104  of the bone  106  with a predetermined force. The two sections  112  and  114  of the suture  110  are then connected with each other to hold the soft body tissue  102  in a desired relationship with the bone  106 . If desired, a force distribution member, such as a button, may be provided between the suture  110  and the soft body tissue  102 . 
         [0077]    An apparatus  120  for tensioning the two sections  112  and  114  of the suture  110  has been illustrated schematically in  FIG. 6 . The apparatus  120  includes a pair of rotatable wheels or pulleys  122  and  124 . The rotatable wheels or pulleys  122  and  124  are connected to force measurement transducers which have an output which is proportional to the sideward force applied to the wheels. Thus, when the suture section  112  is tensioned, a leftward force (as viewed in  FIG. 6 ) is applied to the rotatable wheel  122 . A transducer connected with the wheel  122  is effective to provide an output signal which varies as a function of the leftward force applied to the wheel  122  by the suture  112 . Of course, as the tension in the suture increases, the sideward force applied against the wheel  122  increases. 
         [0078]    Although many different types of known force measuring transducers may be utilized, a solid state force measuring transducer may be preferred. The solid state force measuring device may be a piezoelectric transducer using a piezoelectric crystal as a sensitive unit. The output from the transducer is transmitted to a controller  128 . 
         [0079]    Similarly, the wheel  124  is connected with a force measuring transducer. The force measuring transducer connected with the wheel  124  has an output which varies as a function of the force applied against the wheel  124  by the section  114  of the suture as the suture is tensioned. The output from the transducer connected with the wheel  124  is also transmitted to the controller  128 . 
         [0080]    When the output from the transducers indicates that the desired tension is present in the sections  112  and  114  of the suture  110 , clamps  132  and  134  are activated to hold the wheels  122  and  124  against rotation and to hold the sections  112  and  114  of the suture  110  against movement relative to the wheels. For example, the suture section  112  is manually pulled and the wheel  122  rotated until the output from the transducer connected with the wheel indicates that a desired tension is present in the section of the suture. The controller  128  then activates the clamp  132  to hold both the wheel  122  and the section  112  of the suture against movement. This results in the desired tension being maintained in the section  112  of the suture. Similarly, when the output from the transducer connected with the wheel  124  indicates to the controller  128  that the desire tension is present in the section  114  of the suture, the clamp  134  is activated to clamp the wheel  124  and suture section  114  against movement. 
         [0081]    In response to detecting that the desired tension is present in both sections  112  and  114  of the suture  110 , the controller  128  activates a connector assembly  140  ( FIG. 6 ) to press the soft body tissue  102  against the bone  106  with a predetermined force. In response to detecting that the desired tension is present in the sections  112  and  114  of the suture and that the soft body tissue  102  is being pressed against the bone  106  with a desired force, the controller  128  affects operation of the connector assembly  140  to connect the sections  112  and  114  of the suture  110  together. 
         [0082]    When the controller detects that the desired tension is present in the sections  112  and  114  of the suture  110 , the controller activates an actuator (not shown) to press members  142  and  144  in the connector assembly  140  downward against the body tissue  102  with a predetermined force. While the body tissue  102  is being urged downward with a predetermined force and while a desired tension is being maintained in the sections  112  and  14  of the suture  110 , the connector assembly  140  is operated to interconnect the sections  112  and  114  of the suture. The sections  112  and  114  of the suture may be interconnected with a retainer having the same construction as the retainer  82  of  FIG. 4 . Alternatively, the sections  112  and  114  of the suture may be bonded together. Regardless of how the suture sections are interconnected, a force distribution member may be provided. 
         [0083]    To effect a bonding of the sections  112  and  114  of the suture together, the member  142  functions as an anvil and the member  144  functions as a horn to press the two sections  112  and  114  of the suture against each other and at the same time to transmit ultrasonic vibratory energy to at least one of the two sections of the suture. To press the sections  112  and  114  of the suture against each and to apply ultrasonic vibratory energy to the sections of the suture, the anvil  142  is pressed against one side of the suture sections  112  and  114 . The horn  144  is pressed against the opposite side of the suture sections  112  and  114 . 
         [0084]    The specific force with which the horn and anvil  144  and  142  are pressed against opposite sides of the suture sections  12  and  114  will depend upon the composition of the suture sections and the desired extent of deformation of the suture sections. When at least one, and probably both of the suture sections  112  and  114  have been heat softened by ultrasonic vibratory energy, the material of the suture sections  112  and  114  is pliable. The material of the suture sections  112  and  114  then is plastically deformed by the force applied against the suture sections by the anvil  142  and horn  144 . 
         [0085]    In addition to the anvil  142  and horn  144 , the apparatus for transmitting ultrasonic vibratory energy to the suture sections  112  and  114  includes a generator (not shown) which changes standard electrical power into electrical energy at the desired ultrasonic frequency. A transducer (not shown) changes the electrical energy into low amplitude mechanical motion or vibration. These vibrations are transmitted to a booster which is used to increase or decrease the amplitude of the vibration. The vibrations are then transmitted to the horn  144 . 
         [0086]    The ultrasonic vibratory energy transmitted to the suture sections  112  and  114  from the horn  144  is converted into heat energy. When this occurs, the temperature of the material forming the portions of the suture sections  112  and  114  adjacent to the horn  144  increases. As the temperature of the suture sections  112  and  114  increases, the material of the suture sections is heated into the lower end portion of a transition temperature range. As the material of the suture sections  112  and  114  is heated into the transition temperature range, the material softens and become pliable. However, the material of the suture sections  112  and  114  does not melt an retains sufficient strength to enable the desired tension to be transmitted through the suture sections. 
         [0087]    The somewhat softened material of the heated portions of the suture sections  112  and  114  are pressed together and bond to each other. The materials of the suture sections  112  and  114  are chemically compatible so that a molecular bond can be established between the suture sections. Like materials, that is materials having chemical properties which are the same or very similar will usually bond together. However, dissimilar materials may bond if their melt temperatures are reasonably close and they are of like molecular structure. Generally speaking, amorphous polymers are readily bonded to each other. 
         [0088]    One known source of devices for effecting an ultrasonic bond is Dukane Corporation, Ultrasonics Division, 2900 Dukane Drive, St. Charles, Ill. 60174. The connector assembly  140  may have a construction similar to constructions of connector assemblies disclosed in U.S. patent application Ser. No. 09/524,397 filed Mar. 13, 2000 by Peter M. Bonutti et al. and entitled “Methods of Using Ultrasonic Vibration to Secure Body Tissue”. The disclosure in the aforementioned application Ser. No. 09/524,397 has been and hereby is incorporated herein in its entirety. 
       Embodiments of FIGS. 7 and 8 
       [0089]    In the embodiments of the invention illustrated in  FIGS. 1-6 , the anchor has been utilized to secure a suture relative to a bone in a human patient&#39;s body. In the embodiment of the invention illustrated in  FIGS. 7 and 8 , an anchor is utilized to secure a suture relative to soft body tissue in a human patient&#39;s body. Since the embodiment of the invention illustrated in  FIGS. 7 and 8  is similar to the embodiment of the invention illustrated in  FIGS. 1-6 , similar terminology will be utilized to identify similar components. 
         [0090]    In the embodiment of the invention illustrated in  FIGS. 7 and 8 , a relatively thick layer of soft body tissue, designated by numeral  150 , and a thin layer of soft body tissue, designated by numeral  152 , are to be interconnected by a tissue securing system  154 . The tissue securing system  154  ( FIG. 8 ) includes an anchor  158  which is connected with a retainer  160  by a suture  162 . Although only a single tissue securing system has been disclosed in association with the layers  150  and  152  of soft human body tissue, it is contemplated that a plurality of tissue securing systems could be associated with the layers of human body tissue. The tissue securing systems may be positioned a precise distance from an edge portion of the layers of human body tissue in the manner disclosed in the aforementioned U.S. patent application Ser. No. 09/524,397 filed Mar. 13, 2000 by Peter M. Bonutti et al. and entitled “Methods of Using Ultrasonic Vibration to Secure Body Tissue”. 
         [0091]    The anchor  158  has the same construction as the anchor  20  of  FIGS. 1 and 2 . The anchor  158  is integrally formed as one ;piece of freeze dried human bone. The suture  162  has the same construction as the suture  36  of  FIGS. 3 and 4 . The suture  162  has a cable-like construction with a plurality of interconnected strands formed of the materials previously mentioned in conjunction with the suture  36 . The suture  162  has a section  166  which extends from a passage  168  ( FIG. 7 ) in the anchor  158 . In addition, the suture  162  has a section  170  which extends from a passage  172  in the anchor  158 . 
         [0092]    When the anchor  158  is to be positioned relative to the layers  150  and  152  of soft body tissue, a ;pointed leading end portion  176  is positioned in engagement with one of the layers of body tissue. At this time, a central axis of the anchor  158  extends perpendicular to the layer  152  of body tissue. In the embedment of the invention illustrated in  FIG. 7 , the anchor  158  is positioned in engagement with an imperforate surface area on the thin layer  152  of body tissue. However, it is contemplated that the anchor could be inserted from the other side of the two layers of body tissue if desired. If this was done, the anchor  158  would initially be positioned in engagement with an imperforate surface area on the thick layer  150  of body tissue. 
         [0093]    Once the anchor  158  has been positioned relative to the layer  152  of body tissue, a force, indicated schematically at  180  in  FIG. 7 , is applied against a trailing end of the anchor. The force  180  is effective to push the hard cortical bone of the anchor  158  through the two layers  152  and  150  of body tissue. Thus, the force  180  initially presses the pointed leading end portion  176  of the anchor  158  against the thin layer  152  of body tissue. As the anchor  158  moves into the body tissue under the influence of the force  180 , the anchor initiates the formation of an opening in the layer  152  of body tissue at a location which is free of openings. The pointed leading end portion  176  of the anchor deflects body tissue sideways to initiate formation of an opening in the layer  152 . 
         [0094]    Continued movement of the anchor  158  into the layer  152  of body tissue moves the leading end portion  176  of the anchor into engagement with an imperforate surface on the second or lower (as viewed in  FIG. 7 ) layer  150  of body tissue. The leading end portion  176  of the anchor  158  penetrates the layer  150  of body tissue and initiates the formation of an opening under the influence of the continuing force  180 . As the anchor moves through the body tissue, the trailing end portion of the anchor moves out of the lower (as viewed in  FIG. 7 ) layer  150  of body tissue. The viscoelastic material of the body tissue resiliently closes behind the anchor  158  as it passes through the body tissue. This results in the layers  150  and  152  of body tissue engaging the two sections  166  and  170  of the suture. 
         [0095]    The pointed leading end portion  176  of the anchor  158  is effective to form openings in the layers  150  and  152  of body tissue at locations which were previously free of openings. Thus, the leading end portion  176  of the anchor  158  moves into engagement with an imperforate surface area on an upper or outer side of the thin layer  152  of body tissue and initiates the formation of an opening in the body tissue. Similarly, as the anchor  158  engages the upper side surface of the lower layer  150  of body tissue, the pointed leading end portion  176  initiates the formation of an opening at an imperforate surface area on the lower layer of body tissue. The openings formed by the anchor  158  as it moves through the layers  150  and  152  of body tissue is closed behind the anchor due to the viscoelastic nature of the body tissue. 
         [0096]    The anchor  158  can be moved through the layers  150  and  152  of body tissue under the influence of force applied against the trailing end of the anchor by an inserter assembly which may include a sleeve and pusher member, corresponding to the sleeve  58  and pusher member  60  of  FIG. 3 . The inserter assembly for moving the anchor  158  may have a construction similar to any one of the constructions disclosed in the previously mentioned U.S. Pat. No. 5,948,002 which has been and hereby is incorporated herein. 
         [0097]    Once the anchor  158  has been moved through the layers  150  and  152  of body tissue, the section  166  of the suture  162  is tensioned. The anchor  158  and the layers  150  and  152  of body tissue apply sufficient friction against the section  170  of the suture  162  that tensioning the section  166  of the suture is effective to apply a torque to the anchor which rotates if from the orientation illustrated in  FIG. 7  to the orientation illustrated in  FIG. 8 . When the anchor  158  is in the orientation illustrated in  FIG. 8 , the central axis of the anchor extends generally parallel to the major side surfaces of the layers  150  and  152  of body tissue. At this time, the two sections  166  and  170  of the suture can be tensioned and freely moved relative to the anchor to adjust the relative lengths of the sections  166  and  170  of the suture. 
         [0098]    The sections  166  and  170  of the suture are connected with the retainer  160  in the same manner as previously explained in conjunction with the retainer  82  in  FIG. 4 . In the illustrated embodiment of the retainer  160 , the retainer has a spherical configuration with a cylindrical central passage. However, it is contemplated that the retainer  160  could have a configuration of any one of the retainers disclosed in the aforementioned U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 by Peter m. Bonutti et al. and entitled “Method and Apparatus for Securing a Suture”. Alternatively, the retainer  160  could have a configuration corresponding to the configuration of any other known retainer. 
         [0099]    When the suture  162  has been positioned relative to the retainer, the suture is tensioned with a predetermined tension force. The retainer  160  is then moved along the sections  166  and  170  of the suture and pressed against the layers  152  and  150  of body tissue with a predetermined force. If desired, a force distribution member such as a button, could be provided between the retainer  160  and the layer  152  of body tissue. Another force distribution member could be provided between the anchor  158  and the layer  150  of body tissue. 
         [0100]    While the predetermined tension is maintained in the suture  162  and while the retainer  160  is urged toward the body tissue with a predetermined force, the retainer  160  is fixedly connected with the suture  162 . The retainer  160  may be fixedly connected with the suture by plastically deforming material of the suture retainer with a cold flowing action or by heating the material of the retainer and plastically deforming the material of the retainer while it is heated into a transition temperature range for the material of the retainer. Heating of the material of the retainer may be accomplished by applying ultrasonic vibratory energy against the suture retainer in the manner disclosed in the aforementioned application Ser. No. 09/524,397, filed Mar. 13, 2000 by Peter M. Bonutti et al. and entitled “Method of Using Ultrasonic Vibration to Secure Body Tissue”. Alternatively, the retainer  160  may be connected with the suture  162  in any one of the ways disclosed in the aforementioned U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 by Peter M. Bonutti et al. and entitled “Method and Apparatus for Securing a Suture”. 
       Embodiment of FIG. 9 
       [0101]    In the embodiment of the invention illustrated in  FIGS. 7 and 8 , a tissue securing system  154  is utilized to interconnect layers  150  and  152  of body tissue. A retainer  160  is associated with a suture to apply a predestined force against the layers  150  and  152  of body tissue and to maintain a predetermined tension in the sections  166  and  170  of the suture. In the embodiment of the invention illustrated in  FIG. 9 , the suture retainer is omitted and the sections of the suture are connected directly to each other. Since the embodiment of the invention illustrated in  FIG. 9  is similar to the embodiments of the invention illustrated in  FIGS. 1-8 , similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated in  FIGS. 1-8  could be utilized in association with the embodiment of the invention illustrated in  FIG. 9 . 
         [0102]    In the embodiment of the invention illustrated in  FIG. 9 , soft tissue layers  180  and  182  are disposed in linear apposition with each other. A tissue security system  184  is utilized to interconnect the layers  180  and  182  of soft human body tissue. The tissue security system  184  includes an anchor  188  and a suture  190 . The anchor  188  has the same construction as the anchor  20  of  FIGS. 1 and 2 . The specific anchor  188  illustrated in  FIG. 9  is formed as one piece of freeze dried human bone. The suture  190  has the same construction as the suture  36  of  FIGS. 3 and 4 . 
         [0103]    The suture  190  is connected with the anchor in the same manner as previously described in conjunction with the embodiment of the invention illustrated in  FIGS. 7 and 8 . The suture  190  has sections  192  and  194  which extend from passages  196  and  198  through the layers  180  and  182  of body tissue. In the embodiment of the invention illustrated in  FIG. 9 , a force distribution member of button  196  is provided adjacent to the upper  9  (as viewed in  FIG. 9 ) major side surface of the layer  180  of tissue. The force distribution member  190  distributes force transmitted from the suture  190  over a relatively large area on the layer  180  of tissue. 
         [0104]    The two sections  192  and  194  of the suture are tensioned with a predetermined tension force. The force distribution member  196  is pressed against the layer  180  of body tissue with a predetermined force. While the predetermined tension is maintained in the suture  190  and while the force distribution member  196  is pressed against the layer  180  of tissue with a predetermined force, the two sections  192  and  194  of the suture  190  are bonded to each other by a connector assembly  200 . 
         [0105]    The connector assembly  200  may have the same construction as previously described in conjunction with the embodiment of the invention illustrated in  FIG. 6 . Of course, the connector assembly  200  may have a construction which is different than the construction of the connector assembly  140  of  FIG. 6 . If desired, the two sections  192  and  194  of the suture  190  may be tensioned with a predetermined force by an apparatus have the same construction as the apparatus  120  of  FIG. 6 . It should be understood that the two sections  192  and  194  of the suture  190  may be tensioned in a different manner if desired. For example, the suture sections  192  and  194  could be manually tightened without using the apparatus  120  of  FIG. 6 . 
         [0106]    The connector assembly  200  includes an anvil  202  which is pressed against one side of the sections  192  and  194  of the suture  190 . A horn  204  is pressed against the opposite sides of the sections  192  and  194  of the suture  190 . While the horn and anvil  202  and  204  are being pressed against opposite sides of the sections  192  and  194  of the suture  190 , ultrasonic vibratory energy is transmitted from the horn  204  to at least one of the sections of the suture. The ultrasonic vibratory energy transmitted from the horn  204  to the sections  192  and  194  of the suture  190  is effective to heat the material of the sections of the suture into their transition temperature range as the sections of the suture are pressed against each other. 
         [0107]    When the sections of the suture have been heated into their transition temperature range, they are bonded to each other. The extent to which the sections  192  and  194  of the suture  190  are heated in sufficient to soften the material of the suture. However, the sections  192  and  194  of the suture are not heated to a temperature which is so great as to impair the strength of the suture  190 . This enables the desired tension force to continue to be transmitted through the sections  192  and  194  of the suture  190  as they are bonded to each other by the anvil  202  and horn  04  of the connector assembly  200 . The manner in which the connector assembly  200  interconnects the sections  192  and  194  of the suture  190  is the same as is disclosed in the aforementioned U.S. patent application Ser. No. 09/524,397 filed Mar. 13, 2000 by Peter M. Bonutti et al. and entitled “Method of Using Ultrasonic Vibration to Secure Body Tissue”. 
       Embodiment of FIGS. 10 and 11 
       [0108]    In the embodiments of the invention illustrated in  FIGS. 1-9 , a suture is tensioned with a desired force and a desired force is transmitted to body tissue before a retainer is connected with the suture ( FIGS. 4 and 8 ) or sections of the suture are connected together ( FIGS. 6 and 9 ). An apparatus for use in tensioning the suture and effecting the transmittal of force to body tissue is illustrated in  FIGS. 10 and 11 . Although the apparatus of  FIGS. 10 and 11  is advantageously used with a retainer, the apparatus may be used without a retainer if desired. Since the embodiment of the invention illustrated in  FIGS. 10 and 11  is similar to the embodiments of the invention illustrated in  FIGS. 1-9 , similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated in  FIGS. 1-9  may be used with the embodiment of the invention illustrated in  FIGS. 10 and 11 . 
         [0109]    An apparatus  220  ( FIGS. 10 and 11 ) is utilized to secure a suture  222  ( FIG. 11 ) relative to body tissue. The suture  222  may have the same construction as the suture  36  if  FIGS. 3 and 4 . The specific suture  222  is a cable with a plurality of interconnected strands or filaments. However, the suture  222  could be formed of a single strand if desired. 
         [0110]    In the embodiment of the invention illustrated in  FIG. 11 , the body tissue includes soft body tissue  224  and bone  226 . The bone  226  includes a compact outer layer  228  which encloses cancellous bone  230 . Although the apparatus  220  has been illustrated in  FIG. 11  in association with soft body tissue  224  and bone  226 , it is contemplated that the apparatus  220  could be utilized in association with just soft tissue in the manner illustrated in  FIG. 8 . Alternatively, the apparatus  220  could be utilized with just hard tissue. Thus, the apparatus  220  could be utilized with fragments of a bone or with separate bones if desired. 
         [0111]    The apparatus  220  includes a housing  234  ( FIG. 10 ). In  FIG. 11 , the housing has been omitted and the apparatus enclosed by the housing has been illustrated schematically. The apparatus  220  ( FIG. 11 ) includes a suture tensioning assembly  238 . The suture tensioning assembly  238  is operable to tension the suture  222  with a predetermined tension force. 
         [0112]    The apparatus  220  also includes a force application assembly  242  ( FIG. 11 ). The force application assembly  242  is operable to apply a predetermined force to a retainer  244  to urge the retainer toward the soft body tissue  224  and bone  226 . The suture tensioning assembly  238  is disposed in the upper end portion of the housing  234  ( FIG. 10 ) and the force application assembly  24  is disposed in the lower end portion of the housing. 
         [0113]    A connector assembly  248  ( FIG. 11 ) is provided in the lower end portion of the housing  234  adjacent to the force application assembly  242 . The connector assembly  248  is operable to connect the retainer  244  with the suture  242 . A predetermined tension force is applied to the suture  242  by the suture tensioning assembly  238  and a predetermined force is transmitted from the force application assembly  242  through the retainer  244  to the soft body tissue  224  and bone  226  when the connector assembly  248  is operated to connect the retainer with the suture. 
         [0114]    A trimmer assembly  252  ( FIG. 11 ) is provided in the housing  234  ( FIG. 10 ). The trimmer assembly  252  is disposed between the suture tensioning assembly  238  and force application assembly  242 . The trimmer assembly  252  is operable to server the suture  222  after the connector assembly  248  has connected the retainer  244  with the suture and while the predetermined tension is present in the suture and a predetermined force is being transmitted from the retainer through the body tissue  224 . 
         [0115]    Operation of the connector assembly  248  and trimmer assembly  252  is controlled by a microprocessor or controller  256 . The controller  256  detects when the predetermined tension is present in the suture  222  and when the predetermined force is transmitted through the retainer  244  to the soft body tissue  224  and bone  226 . In response to detection of the predetermined tension n the suture  222  and the transmission of the predetermined force to the retainer  244 , the controller  256  initiates operation of the connector assembly  248  to connect the retainer  244  with the suture  222 . Immediately thereafter, the controller  256  effects operation of the trimmer assembly  252  to server the suture  222 . 
         [0116]    In the embodiment of the invention illustrated in  FIGS. 10 and 11 , the controller  256  ( FIG. 11 ) effects operation of the connector assembly  248  when both a predetermined tension is present in the suture  222  and a predetermined force is being transmitted through the retainer to the body tissue  224  and bone  256 . However, it is contemplated that the apparatus  220  could be constructed in such a manner as to have the controller  256  effect operation of the connector assembly  248  in response to only detection of a predetermined tension in the suture  222 . Alternatively, the controller  256  could effect operation of the connector assembly  248  in response to only detection of transmission of a predetermined force to the retainer  244  and body tissue  224 . 
         [0117]    In the embodiment of the invention illustrated in  FIGS. 10 and 11 , the controller  256  ( FIG. 11 ) is spaced from the house  234  ( FIG. 10 ). The controller  256  is connected with the apparatus disposed in the housing through a cable  258 . However, it is contemplated that the controller  256  could, if desired, be mounted on or in the housing  234 . 
         [0118]    In the embodiment of the invention illustrated in  FIG. 11 , the suture  222  is connected with an anchor  260  which is embedded in the cancellous bone  230  in a spaced apart relationship with the compact outer layer  228  of the bone  226 . The anchor  260  has the same construction as the anchor  20  of  FIGS. 1 and 2 . Sections  262  and  264  of the suture  222  extend from passages in the anchor through the compact outer layer  228  of the bone  226  and the soft body tissue  224  to the retainer  244 . The sections  262  and  264  of the suture  222  extend through the force transmission assembly  242  and trimmer assembly  252  to the suture tensioning assembly  239 . 
         [0119]    Although the suture  222  is connected with the anchor  260  in the embodiment of the invention illustrated in  FIG. 11 , it is contemplated that the suture  222  could be connected with body tissue in a manner other than through the use of the anchor  260 . For example, suture  222  could be connected with body tissue in any one of the ways disclosed in the aforementioned U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 by Peter M. Bonutti el al. and entitled “Method and Apparatus for Securing a Suture”. 
         [0120]    Of course, the suture  222  could be connected with either hard or soft body tissue in other known ways if desired. For example, the suture could be connected with body tissue in any one of the ways disclosed in the aforementioned U.S. Pat. No. 5,928,267. It is contemplated that the apparatus  220  will be utilized in association with sutures which are connected with many different types of body tissue in many different ways. 
         [0121]    The suture tensioning assembly  238  is operable to tension the suture  222  with at least a predetermined tension force. The suture tensioning assembly  238  includes a circular upper member  270  having an opening through which the sections  262  and  264  of the suture  222  extend. The upper member  270  is movable downward relative to the house  234  from the uppermost position illustrated in  FIG. 10 . Although the upper member  270  can move downward from the position shown in  FIGS. 10 and 11 , the upper member can not move upward from the position shown in  FIGS. 10 and 11 . 
         [0122]    The sections  262  and  264  of the suture  222  are fixedly secured to the upper member  270 . In the embodiment of the invention illustrated in  FIG. 11 , a pin  272  extends upward from the upper member  270 . The sections  262  and  264  of the suture  222  are tied to the pin  272 . 
         [0123]    It should be understood that the sections  262  and  264  of the suture  222  could be connected with the upper member  270  in a different manner if desired. For example, the sections  262  and  264  of the suture could be locked in a V-shaped slot formed in the upper member  270 . Alternatively, a gripper assembly could be provided on the upper member  270  to grip the sections  262  and  264  of the suture. 
         [0124]    A circular lower member  276  in the suture tensioning assembly  238  ( FIG. 11 ) is connected with the upper member  270  by a plurality of springs which have been illustrated schematically at  278  in  FIG. 11 . The lower member  276  is movable relative to the housing  234 . The lower member  276  can only move upward from the position shown in  FIGS. 10 and 11 . When the lower member  276  moves upward, the springs  278  are compressed. 
         [0125]    A pair of manually engageable handles  282  and  284  ( FIG. 10 ) are fixedly connected with diametrically opposite sides of the cylindrical lower member  276 . The handles  282  and  284  extend through slots in the housing  234  and are readily engaged by fingers on the hand of a surgeon during use of the apparatus  220 . The handles  282  and  284  can be manually moved upward (as viewed in  FIG. 10 ) to move the lower member  276  upward relative to the housing  234 . The handles  282  and  284  are engageable with lower ends of the slots in the housing to block downward movement of the lower member  276  from the position shown in  FIG. 11 . 
         [0126]    In order to tension the suture  222 , the sections  262  and  264  of the suture are first tied off at the pin  272 . As the sections  262  and  264  of the suture  222  are tied off at the pin  272 , an initial tension force is transmitted from the suture to the upper member  270 . This initial tension force moves the upper member  270  downward and slightly compress the springs  278 . The handles  282  and  284  are pressed against lower ends of the slots in the housing  234  to resist the initial tension force. 
         [0127]    Fingers on one hand of the surgeon then apply an upwardly directed force against the handles  282  and  284 . This upwardly directed force is applied against the springs  278  ( FIG. 10 ) by the lower member  276 . The upwardly directed force is transmitted through the springs  278  to the upper member  270  and the sections  262  and  264  of the suture  222 . As the force applied against the handles  282  and  284  ( FIG. 10 ) is increased, the springs  278  are compressed and the tension in the sections  262  and  264  of the suture  222  is increased. 
         [0128]    As the springs  278  are compressed, a movable contact  282  ( FIG. 11 ) moves upward toward a second contact  284 . The movable contact  282  is fixedly connected to the lower member  276 . The second contact  284  is fixedly connected to the upper member  270 . The movable contact  282  moves upward into engagement with the second or upper contact  284  when the springs  278  have been compressed to a predetermined extent by movement of the lower member  276  toward the upper member  270 . When the springs  278  have been compressed to the predetermined extent, a predetermined force is transmitted from the lower member  276  to the upper member  270 . This predetermined force is transmitted to the sections  262  and  264  of the suture through the pin  272  connected with the upper member  270 . 
         [0129]    When the movable contact  282  engages the second contact  284  and the predetermined tension force is ;present in the suture  222 , a circuit is completed between conductors  286  and  288  connected with the movable contact  282  and second contact  284 . The conductors  286  and  288  are connected with the controller  256 . This enables the controller  256  to detect when the movable contact  282  engage the second or upper contact  284  and when the predetermined tension is present in the suture  222 . The controller  256  provides a visual and/or an audible signal to indicate to the surgeon that the predetermined tension force is being applied to the sections  262  and  264  of the suture  222 . 
         [0130]    The force application assembly  242  is operable to apply at least a predetermined force to the retainer  244 . This predetermined force urges the retainer toward the soft body tissue  224  and bone  226 . The force transmitted from the retainer  244  to the soft body tissue  224  is effective to compress the soft body tissue against the bone  226 . 
         [0131]    The force application assembly  242  includes a circular lower member  294  which is located at the lower end of the housing  234  ( FIG. 10 ). The lower member  294  is movable upward from its lowermost position shown in  FIG. 11 . The lower member  294  is engageable with the retainer  244 . The lower member  294  may have a lower (as viewed  FIG. 11 ) side surface which is shaped to provide a recess in which the upper portion of the retainer  244  is received. Thus, although the lower member  294  is illustrated in  FIG. 11  as having a flat circular lower side surface, the lower member  294  could have a concave surface with an arc of curvature which corresponds to the arc of curvature of the spherical retainer  244 . 
         [0132]    An upper member  298  in the force application assembly  242  has a generally cylindrical configuration and is disposed in a coaxial relationship with the lower member  294 . The upper member  298  is fixedly connected with the housing  243  ( FIG. 10 ). The lower member  294  is axially movable relative to the housing  234 . The lower member  294  is connected with the upper member  298  by a plurality of springs which have been illustrated schematically at  302  in  FIG. 11 . 
         [0133]    An upper contact  304  is fixedly connected with the upper member  298 . A lower or movable contact  306  is connected with the lower member  294 . The upper contact  304  is connected with the controller  256  by a conductor  310 . The movable contact  306  is connected with the controller  256  by a conductor  312 . 
         [0134]    A guide rod  313  extends between the lower member  294  in the force application assembly  242  and the upper member  270  in the suture tensioning assembly  238 . The guide rod interconnects the suture tensioning assembly  238  and the force application assembly  242 . In addition, the guide rod guides relative movement between the upper member  270  and lower member  276  in the suture tensioning assembly  238  and relative movement between the upper member  298  and lower member  294  in the force application assembly  242 . Although only a single guide rod  313  has been illustrated in  FIG. 11 , it should be understood that a plurality of guide rods are provided in the apparatus  220 . 
         [0135]    When a predetermined force is to be transmitted through the retainer  244  to the body tissue  224  and bone  226 , a knurled handle portion  314  ( FIG. 10 ) of the housing  234  is manually grasped. A collar  315  may be provided adjacent to the lower end of the handle portion  315 . Force is manually applied to the housing  234  urging the housing downward (as viewed in  FIG. 11 ) toward the retainer  244 . At the same time, an upward force is being manually applied against the handles  282  and  284 . 
         [0136]    The downward force which is manually applied to the housing  234  is transmitted to the upper member  298  ( FIG. 11 ) which is fixedly connected with the housing. This downward force is transmitted from the upper member  298  through the springs  302  to the lower member  294 . The lower member  294  transmits the force to the retainer  244  which is pressed against the soft body tissue  224 . 
         [0137]    As the housing  234  and upper member  298  are manually urged downward toward the retainer  244 , the springs  302  ( FIG. 11 ) are compressed. As the springs  302  are compressed, the upper contact  304  approaches the lower contact  306 . When the springs  302  have been compressed to a predetermined extent, a predetermined force is transmitted from the upper member  298  through the springs  302  and lower member  294  to the retainer  244  and body tissue  224 . As this occurs, upper contact  304  engages the lower contact  306 . 
         [0138]    Engagement of the contacts  304  and  306  completes a circuit which enables the controller  256  to detect that at least a predetermined force has been transmitted from the force application assembly  242  to the retainer  244  and the body tissue  224  and bone  226 . 
         [0139]    When the controller  256  detects both the presence of the predetermined tension in the suture  222  and the application of the predetermined force against the retainer  244 , the controller initiates operation of the connector assembly  248  to connect the retainer with the suture. The connector assembly  248  includes a pair of movable members  316  and  318  which are disposed adjacent to diametrically opposite sides of the retainer  244 . An actuator  320  is connected with the movable member  316 . An actuator  322  is connected with the movable member  318 . The actuators  320  and  322  are connected with the controller  256  by conductors  324  and  326 . 
         [0140]    In the embodiment of the invention illustrated in  FIG. 11 , the actuators  320  and  322  are operable to press the movable members  316  and  318  against opposite sides of the retainer  244  and to effect plastic deformation of the material of the retainer  244 . Force applied against opposite sides of the retainer  244  by the members  316  and  318  is effective to cause cold flowing of the material of the retainer at a temperature below a transition temperature range for the material of the retainer. The cold flowing of the material of the retainer  244  results in a collapsing of the passage in the retainer through which the sections  262  and  264  of the suture extend. As the passage through the retainer  244  collapses and the material of the retainer cold flows, the material flows around the sections  262  and  264  of the suture  222 . This enables the material of the retainer  244  to bond to an obtain a firm grip on the suture  222 . 
         [0141]    In the embodiment of the invention illustrated in  FIG. 11 , the sections  262  and  264  of the suture  222  extends straight through the passage in the retainer  244 . However, if desired, the sections  262  and  264  of the suture  222  could be wrapped around the retainer. If this was done, the force applied against the sections of the suture and the retainer  244  would embed the suture turns around the outside of the retainer  244  in the material of the retainer and enhance the grip between the suture  222  and the retainer  244 . 
         [0142]    During the time in which the force application members  316  and  318  are applying clamping forces against opposite sides of the retainer  244 , the retainer is pressed against the upper side surface of the body tissue  224  with a predetermined force. In addition, a predetermined tension is maintained in the sections  262  and  264  of the suture  222 . 
         [0143]    In the embodiment of the invention illustrated in  FIG. 11 , clamping forces have been applied against opposite sides of the retainer  244  to cause cold flowing of the material of the retainer. However, if desired, the connector assembly  248  could be constructed so as to effect heating of the material of the retainer  244  by the application of ultrasonic vibratory energy to the retainer. The frictional heat created by the ultrasonic vibratory energy transmitted to the suture retainer  244  is effective to heat the material of the suture retainer into a transition temperature range to facilitate collapsing of the passage in the retainer and to facilitate bonding of the material of the retainer with the sections  262  and  264  of the suture  222 . If the connector assembly  248  is to be constructed so as to apply ultrasonic vibratory energy to the retainer  244 , the moveable member  316  could be an anvil which engages one side of the retainer and the movable member  318  could be a horn which applies ultrasonic vibratory energy to the retainer. 
         [0144]    Once the retainer  244  has been securely connected with the sections  262  and  264  of the suture  222 , the trimmer assembly  252  is operated to sever the sections  262  and  264  of the suture. The trimmer assembly  252  is operable to sever the sections  262  and  264  of the suture  222  at a location disposed between the suture tensioning assembly  238  and the force application assembly  242 . Since the retainer  244  has been securely connected to the suture before the trimmer assembly  252  is operated, the retainer is effective to maintain the predetermined tension in the sections  262  and  264  of the suture which extend between the retainer and the anchor  260 . In addition, the retainer  244  is effective to apply the predetermined force against the body tissue  224 . 
         [0145]    The trimmer assembly  252  includes a pair of cutter assemblies  340  and  342 . The cutter assemblies  340  and  342  are connected with the controller  256  by conductors  344  and  346 . After completion of operation of the connector assembly  248  to connect the retainer  244  with the sections  262  and  264  of the suture  222 , the controller  256  initiates operation of the cutter assemblies  340  and  342  in the trimmer assembly  252  to sever the sections  262  and  264  of the suture  222 . 
         [0146]    When the suture  222  ( FIG. 11 ), anchor  260  and retainer  244  are to be utilized to secure the soft body tissue  224  with the bone  226 , the suture  222  is inserted through the passages in the anchor  260  in the manner previously explained in conjunction with the embodiment of the invention illustrated in  FIGS. 1-4 . When this has been done, a pointed end portion  352  of the anchor  260  is positioned relative to the soft body tissue  224  while the soft body tissue is in a desired location relative to the bone  226  in the manner illustrated schematically in  FIG. 3 . An inserter assembly is then utilized to move the anchor  20  through the body tissue  224  and into the bone  226 . When the anchor has been moved to a predetermined depth in the cancellous bone  230 , the anchor is toggled from an orientation similar to the orientation illustrated in  FIG. 3  to the orientation illustrated in  FIG. 11 . 
         [0147]    Once the anchor  260  and suture  222  have been positioned relative to the body tissue  224  and bone  226 , the retainer  244  is slid along the sections  262  and  264  of the suture into engagement with the body tissue  224 . The suture sections  262  and  264  are then positioned in the apparatus  220  ( FIG. 10 ). A slot  356  is formed in the apparatus  220  to facilitate positioning of the sections  262  and  264  of the suture in the apparatus. The slot  256  extends through the housing to central portions of the suture tensioning assembly  238  ( FIG. 11 ), force application assembly  242 , connector assembly  248 , and trimmer assembly  252 . Although it is believed that it will be preferred to utilize the slot  356  to facilitate positioning of the suture  222  relative to the apparatus  220 , a passage could be provided through the apparatus and the sections  262  and  264  of the suture inserted through the passage. 
         [0148]    Once the sections  262  and  264  of the suture  222  have been positioned in the apparatus  220 , the apparatus is moved along the suture  222  into engagement with the retainer  244 . While the apparatus  220  is pressed firmly against the retainer  244 , the sections  262  and  264  of the suture are tied to the pin  272 . At this time, there will be some tension in the sections  262  and  264  of the suture  222  and there will be some force transmitted from the force application assembly  242  to the retainer  244 . However, the tension in the suture and the force transmitted to the retainer will be less than a minimum desired tension and force. 
         [0149]    In order to effect the transmission of the desired force from the apparatus  220  through the retainer  244  to the soft body tissue  224  and bone  226 , a surgeon manually grasps the handle portion  314  ( FIG. 10 ) of the housing  234  with one hand and pushes the housing toward the retainer  244  ( FIG. 11 ). As this occurs, the spring  302  in the force application assembly are compressed and the contact  304  moves into engagement with the contact  306  to indicate to the controller that the predetermined force is being transmitted from the apparatus  220  to the retainer  244 . At this time, the controller  256  may provide a visual and/or audible indication to the surgeon that a predetermined force has been transmitted through the retainer  244  to the body tissue  224 . 
         [0150]    The surgeon then grasps the handles  282  and  284  ( FIG. 10 ) with the other hand and pulls the handles upward. As this occurs, the springs  278  in the suture tensioning assembly  238  are compressed and force is applied against the upper member  270  to increase the tension in the suture sections  262  and  264 . When a predetermined tension is present in the suture sections  262  and  264 , the lower contact  282  in the suture tensioning assembly  238  is in engagement with the upper contact  284  to provide an indication to the controller that the predetermined tension is present in the suture. At this time, the controller  256  may provide a second visual or audible signal to the surgeon. 
         [0151]    When the predetermined tension is present in the sections  262  and  264  of the suture  222  and the predetermined force is being transmitted from the retainer  244  to the soft body tissue  224  and bone  226 , the controller  256  effects operation of the connector assembly  248  to securely connect the retainer  244  with the sections  262  and  264  of suture. After the retainer  244  has been connected with the sections  262  and  264  of the suture, the controller  256  effects operation of the trimmer assembly  252  to sever the sections  262  and  264  of the suture. This enables the apparatus  220  to be moved away from the body tissue  224 . 
       Embodiment of FIG. 12 
       [0152]    In the embodiment of the invention illustrated in  FIG. 11 , a suture retainer  244  is connected with the sections  262  and  264  of the suture  222 . In the embodiment of the invention illustrated in  FIG. 12 , the sections of the suture are connected to each other. Since the embodiment of the invention illustrated in  FIG. 12  is similar to the embodiments of the invention illustrated in  FIGS. 1-11 , similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated in  FIGS. 1-11  may be used with the embodiment of the invention illustrated in  FIG. 12 . 
         [0153]    The apparatus  420  is utilized to secure a suture  422  relative to soft body tissue  424  and a bone  426 . The suture  422  may have the same construction as the suture  36  of  FIGS. 3 and 4 . The specific suture  422  is a monofilament having a continuous cylindrical outer side surface. However, the suture  422  may be formed a plurality of intertwined strands or filaments. 
         [0154]    The bone  426  includes a compact outer layer  428  which enclosed cancellous bone  430 . Although the suture  422  has been illustrated schematically in  FIG. 12  as being associated with soft body tissue  424  and a bone  426 , it is contemplated tat the suture could be associated with just soft body tissue or with two portions of a bone or two bones. It should be understood that the suture  422  could be associated with body tissue in any desired way. 
         [0155]    The apparatus  420  includes a suture tensioning assembly  438  which is operable to tension the suture  422  with a predetermined tension force. The apparatus  420  also includes a force application assembly  442  which is operable to transmit a predetermined forced to the soft tissue  424  and bone  426 . The apparatus  420  also includes a connector assembly  448 . 
         [0156]    the connector assembly  448  is operable to connect sections  462  and  464  of the suture with each other while a predetermined tension force is being transmitted through the sections of the suture and while a predetermined force is being transmitted to the soft tissue  424  and bone  426 . Thus, the connector assembly  448  is operable to connect the two sections  462  and  464  of the suture  422  with each other while the suture tensioning assembly  438  tensions the suture to provide a tension force of at least a predetermined magnitude in the sections  462  and  464  of the suture. In addition, the connector assembly  448  is operable to connect the sections  462  and  464  of the suture  422  together while the force application assembly  442  is operable to transmit at least a predetermined force to the soft tissue  424  and bone  426 . 
         [0157]    A trimmer assembly  452  is operable to server the sections  462  and  464  of the suture  422  while the predetermined tension force is present in the sections of the suture and while the predetermined force is transmitted to the soft tissue  424 . 
         [0158]    A controller  456  effects operation of the connector assembly  448  to connect the suture sections  462  and  464  together in response to both detection that at least a predetermined tension force is present in the sections  462  and  462  of the suture and detection that at lest a predetermined force is being transmitted to the soft tissue  424  and bone  426 . The suture tensioning assembly  438 , force application assembly  442 , connector assembly  448 , and trimmer assembly  452  are at lest partially enclosed by a housing which corrections to the housing  234  of  FIG. 10 . The controller  456  is connected with the housing by a suitable cable, corresponding to the cable  258  of  FIG. 10 . However, the controller could be mounted in or on the housing for the apparatus  420  is desired. 
         [0159]    It should be understood that the suture tensioning assembly  438  of  FIG. 12  corresponds to the suture tensioning assembly  238  of  FIG. 11 . Similarly, the force application assembly  442  of  FIG. 12  corresponds to the force application assembly  242  of  FIG. 11 . The connector assembly  448  of  FIG. 12  corresponds to the connector assembly  248  of  FIG. 11 . The trimmer assembly  252  of  FIG. 12  corresponds to the trimmer assembly  252  of  FIG. 11 . 
         [0160]    The suture tensioning assembly  438  ( FIG. 12 ) includes a circular upper member  470  and a circular lower member  472 . In accordance with a feature of the embodiment of the invention illustrated in  FIG. 12 , force transducers  478  interconnect the upper and lower members  472 . The force transducers  478  are connected with the controller  456  by leads  486  and  488 . 
         [0161]    Although the force transducers  478  could have many different construction, it is contemplated that they may be ;piezoelectric transducers having a piezoelectric crystal as a sensitive element. The piezoelectric crystals in the force transducers  478  have outputs which correspond to the magnitude of the force being transmitted from the lower member  422  through the force transducers  478  to the upper member  470 . 
         [0162]    The sections  462  and  464  of the suture  422  are secured to a pin  472  extending upward from the upper member  470 . Therefore, force transmitted from the lower member  472  to the upper member  470  is transmitted from the upper member through the pin  472  to the suture sections  462  and  464 . The output from the force transducers  478  indicates to the controller  456  when a predetermined tension force has been transmitted from the lower member  472  through the force transducers  478  and upper member  470  to the sections  462  and  464  of the suture  422 . 
         [0163]    A pair of handles (not shown), corresponding to the handles  282  and  284  of  FIG. 10 , are connected wit the lower member  472 . The handles connected with the lower member  472  are manually engageable. Force which is manually applied to the handles is transmitted from the lower member  472  through the force transducers  478  to the upper member  470 . 
         [0164]    The force application assembly  442  is operable to transmit a predetermined force to the soft tissue  424  and bone  426 . The force application assembly  442  includes a cylindrical lower member  494  which extends downward into engagement with a force distribution member  496  which is disposed on the soft tissue  424 . The force distribution member or button  496  has a generally circular configuration with a pair of passages through which the sections  462  and  464  of the suture  422  extend. If desired, the force distribution member  496  could be eliminated. 
         [0165]    The force application assembly  494  also includes a cylindrical upper member  498 . The upper member  498  is connected with the housing (not shown) which encloses the apparatus  420  and corresponds to the housing  234  of  FIG. 10 . 
         [0166]    The upper member  498  is connected with the lower member  494  by a plurality of force transducers  502 . The force transducers  502  are connected with the controller  456  through conductors  510  and  512 . The output from the force transducers  502  corresponds to the magnitude of the force transmitted from the upper member  498  to the lower member  494 . 
         [0167]    Although the force transducers  502  may have many different constructions, in one specific embodiment of the invention, the force transducers  502  were piezoelectric transducers having a piezoelectric crystal as the sensitive unit. However, it should be understood that the force transducers could have any desired construction as long as they were capable of providing and output to the controller which would indicate when at least a predetermined force is being transmitted from the upper member  498  to the lower member  494  and the soft tissue  424  and bone  426 . 
         [0168]    The connector assembly  448  includes movable members  516  and  518 . The movable members  516  and  518  are connected with actuators  520  and  522 . The actuators  520  and  522  are connected with the controller  456  by conductors  524  and  526 . 
         [0169]    The movable member  516  and movable member  518  extend through slots formed in the lower member  494 . Thus, the lower member  494  has a cylindrical configuration and includes radically extending slots in which the movable members  516  and  518  are received. The lower (as viewed in  FIG. 12 ) end portion of the lower member  494  is disposed in abutting engagement with the force distribution member  496  and is effective to transmit force to the force distribution member. Although the movable members  516  and  518  have been illustrated schematically in  FIG. 12  as being spaced from the force distribution member  496 , it should be understood that the movable members engage and slide along the force distribution member. 
         [0170]    When the controller  456  receives an output from the transducers  478  indicating that at least a predetermined tension is present in the sections  462  and  464  of the suture  422  and receives an output from the force transducers  502  indicating that at lest a predetermined force is being transmitted to the soft tissue  424  and bone  426 , the controller  456  effects operation of the connector assembly  448  to interconnect the sections  462  and  46  of the suture  422 . Thus, the controller  456  effects operation of the actuators  520  and  522  to press the members  516  and  518  against opposite sides of the sections  462  and  464  of the suture  422 . While a predetermined clamping force is being applied against the suture sections  462  and  464  to press them against each other, the controller  456  effects operation of the connector assembly  448  to connect the sections  462  and  464  of the suture  422  to each other. 
         [0171]    In the embodiment of the invention illustrated in  FIG. 12 , the sections  462  and  464  of the suture  422  are connected to each other by the application of pressure and ultrasonic vibratory energy to the sections of the suture. To enable ultrasonic vibratory energy to be transmitted to the sections of the suture, the movable member  516  functions as an anvil and the movable member  518  functions as a horn. 
         [0172]    The movable member or horn is  518  vibrated at a rate in excess of 20 kilohertz. Although the horn  518  may be vibrated at any desired frequency within a range of 20 kilohertz to 70 kilohertz, it is believed that it may be desirable to vibrate the horn or movable member  518  at a rate which is close to or greater than 70 kilohertz. The horn  518  is vibrated for a dwell time which is sufficient to transmit enough ultrasonic vibratory energy to the sections  462  and  464  of the suture to heat a portion of the material of the sections of the suture into a transition temperature range of the material. 
         [0173]    To effect a heating of the material of the suture sections  462  and  464 , mechanical vibrations are transmitted from the horn or moveable member  518  to an interface where the suture sections  462  and  464  are pressed against each other by the anvil  516  and horn  518 . As the material of the suture sections  462  and  464  are heated into a transition temperature range, the material loses its rigidity and softens. However, the material of the sections  462  and  464  of the suture  422  do not melt and lose substantial tensile strength as the material is heated. 
         [0174]    The heated and softened material of the sections  462  and  464  of the suture  422  are flattened from a cylindrical configuration to form thin layers which are disposed in a side-by-side relationship and have a generally plate-like configuration. As the sections  462  and  464  of the suture are pressed together and flattened, they expand in opposite directions transverse to the central axes of the suture sections. 
         [0175]    After the suture sections have been interconnected by the connector assembly  448 , a trimmer assembly  452  is operated to sever the suture sections  462  and  464  at a location between the suture tensioning assembly  438  and force application assembly  442 . The trimmer assembly  452  includes cutter assemblies  540  and  542  which are connected with the controller  456  by conductors  544  and  546 . A predetermined time period after the connector assembly  448  has interconnected the suture sections  462  and  464 , the controller  456  effects operation of actuators in the cutter assemblies  540  and  542  to sever the suture sections. 
       CONCLUSION  
       [0176]    In view of the forgoing description, it is apparent that the present invention relates to a method and apparatus for use in securing soft tissue  40 , hard tissue  44 , and/or hard and soft tissue in a patient&#39;s body. The hard tissue may be any one of the many bones in a patient&#39;s body. The soft tissue may be any one of the tissues in a patient&#39;s body other than the hard tissue. 
         [0177]    The tissue may be secured by using a suture  36 . The suture may be connected with an anchor  20 . When the anchor  20  is utilized in association with the suture, the anchor may be formed of any one of many different materials including bone or other body tissue, biodegradable materials, or non-biodegradable materials. The anchor  20  may be formed to two or more different materials. 
         [0178]    When a suture  36  is utilized to secure body tissue  40  and  44 , a retainer  82  may be connected with the suture. Alternatively, sections  112  and  114  of the suture  110  may be connected with each other. 
         [0179]    If a suture  110  is utilized to secure the body tissue, an apparatus  120 ,  220  or  420  may advantageously be provided to tension the suture with a predetermined force. If a retainer  244  is utilized in association with the suture, the apparatus  220  may urge the retainer toward the body tissue with a predetermined force. The retainer  244  may be connected with the suture  222  in response to detection of at least a predetermined tension in the suture and/or the transmission of a predetermined force to the body tissue  224 . When the retainer  244  is to be eliminated, the sections  462 ,  464  of the suture  422  may be interconnected in response to detection of a predetermined tension in the suture and/or detection of the transmission of a predetermined force to the body tissue. 
         [0180]    The anchor  22 , for some uses at least, may be formed of a single piece of bone. A pointed end portion  24  of the anchor may have a surface which forms an opening in a bone or other tissue in a patient&#39;s body. The anchor  22  may be moved into the opening formed in the tissue by the pointed leading end portion of the anchor. 
         [0181]    It should be understood that in certain situations, it may be desired to use just a suture, without an anchor, to secure the body tissue. In these situations, a retainer  82  may be connected with the suture. Alternatively, sections of the suture may be directly connected with each other. In other situations, it may be desired to use an anchor, without a suture, to secure body tissue. 
         [0182]    All references cited herein are expressly incorporated by reference in their entirety. 
         [0183]    It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.