Method and apparatus for securing tissue

Abstract

An anchor has a pointed end portion may be utilized to form an opening in a bone in a patient's body. The anchor is moved into the opening formed in the bone in the patient's body with a suture connected to the anchor. The suture may then be utilized to retain body tissue in a desired position relative to the bone. The body tissue may be either hard or soft body tissue. If desired, the anchor may be utilized in conjunction with layers of soft body tissue. When a suture is used it may be secured by connecting a retainer with the suture. Alternatively, sections of the suture may be interconnected. It is believed that it may be preferred to secure the suture in place after at least a predetermined tension has been established in the suture and/or a predetermined force has been transmitted to the body tissue. The suture may be secured in place by exposing a retainer to ultrasonic vibratory energy or by applying the ultrasonic vibratory energy directly to sections of the suture.

1 . A method of connecting body tissue to a bone in a body, comprising the steps of:
 piercing an aperture in the cortical layer of the bone;   connecting a suture to a fastener having
 a leading end, 
 a trailing end, 
 an aperture near the leading end operative to receive the suture, and 
 a length longer than the width of the pierced aperture; 
   pushing the fastener, with suture attached, through the pierced bone, in a forward direction defined as leading end first, until the entire fastener lies within the cancellous matter inside the bone;   pulling on the suture to position the fastener inside the bone, wherein the fastener moves in a rearward direction and rotates about an axis having a location substantially determined by
 resistance to movement in a rearwards direction by engagement of the trailing end with cancellous matter, 
 the location near the leading end where force is applied, 
 the length of the fastener, and 
 the width of the fastener; and 
   attaching the suture to the body tissue to be connected to the bone;   wherein the fastener rotates to lie beneath and substantially parallel to the inner surface of cortical bone, whereby the suture is fastened within the bone.   
     
     
         2 . The method of  claim 1 , wherein the fastener has a tapered leading end, and wherein said piercing step includes piercing an aperture in the cortical layer of the bone by pushing said tapered leading end against the bone. 
     
     
         3 . The method of  claim 2 , wherein in said pulling step, the location of the axis of rotation is further determined by a reduced resistance of the tapered leading end to movement through cancellous matter. 
     
     
         4 . The method of  claim 1 , wherein said fastener has a second aperture, and
 wherein a first portion of the suture passes through the aperture near the leading end and a second portion of the suture passes through the second aperture, and   wherein said step of pulling further includes pulling the first portion of the suture a greater distance than the second portion of the suture is pulled.   
     
     
         5 . The method of  claim 4 , further including, after the step of attaching, the step of connecting the first and second suture portions together using the application of ultrasonic vibratory energy. 
     
     
         6 . The method of  claim 4 , further including, after the step of attaching, the step of bonding the first and second suture portions together by generating heat through the application of ultrasonic vibratory energy. 
     
     
         7 . The method of  claim 4 , further including, after the step of attaching, the steps of:
 passing the first and second suture portions through a retainer operative to grip the suture portions.   
     
     
         8 . The method of  claim 7 , further including, after the step of passing, the steps of:
 tensioning the first and second suture portions in a direction away from the bone;   sliding the retainer towards the bone;   squeezing the retainer to grip the first and second suture portions;   applying ultrasonic vibratory energy to the retainer;   releasing the compressive force about one second after applying ultrasonic vibratory energy;   whereby the first and second suture portions are connected at least to the retainer, and are thereby fixed relative to each other, whereby the body tissue is connected to the bone.   
     
     
         9 . The method of  claim 1 , wherein the cancellous matter serves as a fulcrum, and leverage is created by positioning the aperture near the leading end. 
     
     
         10 . The method of  claim 1 , wherein the fastener is fabricated from a material selected from the group consisting of: bone, autogenic bone, lyophilized bone, cortical bone, polymer, bioerodible polymer, biodegradable polymer, allograft, xenograft, metal, titanium, stainless steel. 
     
     
         11 . The method of  claim 1 , wherein the sutures are polymeric. 
     
     
         12 . The method of  claim 1 , wherein the body tissue to be connected is a ligament or tendon. 
     
     
         13 . The method of  claim 1 , wherein the body tissue to be connected comprises multiple layers. 
     
     
         14 . A method of connecting body tissue to a bone in a body, comprising the steps of:
 piercing an aperture in the cortical layer of the bone;   connecting a suture to a fastener having
 a leading end, 
 a trailing end, 
 a first aperture near the leading end, 
 a second aperture, and 
 a length longer than the width of the pierced aperture, 
 a first suture portion passing through the first aperture, and a second suture portion passing through the second aperture; 
   pushing the fastener, with suture attached, through the pierced bone, in a forward direction defined as leading end first, until the entire fastener lies within the cancellous matter inside the bone;   pulling the first suture portion a greater distance than the second suture portion is pulled, thereby positioning the fastener inside the bone, wherein the fastener moves in a rearward direction and rotates about an axis having a location substantially determined by
 resistance to movement in a rearwards direction by engagement of the trailing end with cancellous matter, 
 the location near the leading end where force is applied, 
 the length of the fastener, and 
 the width of the fastener; and 
   attaching the suture to the body tissue to be connected to the bone;   wherein the fastener rotates to lie beneath and substantially parallel to the inner surface of cortical bone, whereby the suture is fastened within the bone.   
     
     
         15 . A device for installing a suture in body tissue, comprising:
 at least one body tissue engaging surface operative to apply pressure to body tissue to be sutured;   a first suture engaging surface disposed proximate said body tissue engaging surface and operative to transmit ultrasonic vibratory energy to suture sections and generate heat within the suture sections thereby bonding the suture sections together;   a second suture engaging surface disposed in opposed mating and moveable relation to said first suture engaging surface, operative to hold suture sections against said first suture engaging surface during the transmission of ultrasonic vibratory energy,   at least one sensor connect in spaced apart relation to said body tissue engaging surface, operative to measure a tensioning force applied to at least one suture section;   at least one clamp connected in spaced apart relation to said body tissue engaging surface, operative to maintain a tension upon a suture;   wherein body tissue is pressed by said at least one body tissue engaging surface, and at least two suture sections
 extend away from body tissue to be sutured, 
 are pulled to a desired tension as measured by said first and second sensors, 
 are maintained in tension by said at least one clamp, and 
 are bonded together by being pressed between said first and second suture engaging surfaces. 
   
     
     
         16 . The device of  claim 15 , further including a cutter disposed between said first and second suture engaging surfaces and said at least one clamp, operative to cut suture sections after the suture sections are bonded. 
     
     
         17 . The device of  claim 15 , further including at least one pulley operative to:
 rotatably engage suture sections;   impart a force to said at least one sensor, proportionate to the force with which the sutures are tensioned.   
     
     
         18 . The device of  claim 15 , wherein a suture retainer is connected to the at least two suture sections, and wherein the retainer is pressed between said first and second suture engaging surfaces, whereby the suture sections are bonded together in association with the retainer. 
     
     
         19 . The device of  claim 15 , wherein said at least one sensor measures tension in each of two suture sections. 
     
     
         20 . The device of  claim 15 , further including:
 a processing unit connected to said at least one sensor;   means cooperative with said processor for moving said first and second suture engaging surfaces into mating relationship, and for controlling the transmission of ultrasonic energy from said first suture engaging surface;   whereby when a desired tension is measured by said at least one sensor, said processing unit causes said first and second suture engaging surfaces to move into mating relationship, and said first suture engaging surface to transmit ultrasonic vibratory energy, thereby bonding the suture sections.   
     
     
         21 . The device of  claim 20 , further including:
 a cutter disposed between said first and second suture engaging surfaces and said at least one clamp, operative to cut suture sections after the suture sections are bonded;   means cooperative with said processor for controlling said cutter;   whereby said processor causes the suture sections to be cut after the suture sections are bonded.   
     
     
         22 . The device of  claim 15 , wherein said second suture engaging surface is further operative to transmit ultrasonic vibratory energy. 
     
     
         23 . The device of  claim 15 , wherein the suture sections are formed from a material selected from the group consisting of: polymer, amorphous polymer. 
     
     
         24 . The device of  claim 15 , wherein a single suture passes through a first of said at least one clamp, past said first suture engaging surface, into the body tissue, out of the body tissue, past said second suture engaging surface, and through a second of said at least one clamp. 
     
     
         25 . The device of  claim 15 , wherein said at least one body tissue engaging surface applies a predetermined pressure to the body tissue. 
     
     
         26 . The device of  claim 15 , wherein at least one of said at least one body tissue engaging surface is threaded onto a suture and remains in the body after the suture is installed. 
     
     
         27 . A device for installing a suture in body tissue, comprising:
 a suture tensioning member including a suture holder;   a suture tensioning coupling having first and second ends, said first end attached to said suture tensioning member;   a handle attached to the second end of said suture tensioning coupling, operative to urge the suture tensioning member in a direction away from the body when said handle is moved;   a suture tension indicator cooperative with said suture tensioning coupling operative to indicate when suture tension has reached a predetermined tension force;   a body tissue pressing member;   a body tissue pressing coupling having first and second ends, said first end attached to said body tissue pressing member;   a body tissue pressure indicator cooperative with said body tissue pressing coupling operative to indicate when body tissue pressure has reached a predetermined pressure force;   a frame attached to the second end of said body tissue pressing coupling, operative to press the body tissue pressing member against the body when said frame is moved towards the body;   an ultrasonic bonding member comprising an ultrasonic vibratory energy transmitter and a suture support member, movable together to apply a compressive force and ultrasonic vibratory energy to at least two suture sections, and operative thereby to bond at least two suture sections together, said ultrasonic bonding member disposed adjacent to the body tissue pressing member in use;   wherein in use,   (a) at least two suture sections connected to body tissue extend away from the body and pass between said ultrasonic vibratory energy transmitter and said suture support member and are then connected to said suture holder,   (b) said frame is pushed towards the body with increasing force, until said body tissue pressure indicator indicates body tissue pressure has reached a predetermined pressure force,   (c) said handle is moved with increasing force, until said suture tension indicator indicates suture tension has reached a predetermined tension force, and   (d) said ultrasonic bonding member is then operated to bond the at least two suture sections together,   whereby a suture is installed in the body in a reliable and reproducible manner.   
     
     
         28 . The device of  claim 27 , wherein said suture tensioning coupling includes at least one tension resilient member, and said suture tension indicator includes an electrical contact associated with said at least one tension resilient member, and
 said body tissue pressing coupling includes at least one pressure resilient member, and said body tissue pressure indicator includes an electrical contact associated with said at least one pressure resilient member.   
     
     
         29 . The device of  claim 28 , wherein said tension and pressure resilient members are springs. 
     
     
         30 . The device of  claim 27 , further including:
 an electronic processor; and   display means associated with said electronic processor;   wherein said suture tensioning coupling includes at least one tension force transducer connected to said processor, and   said body tissue pressing coupling includes at least one pressure force transducer connected to said processor,   whereby force levels of said suture tensioning coupling and said body tissue pressing coupling are indicated, respectively, upon said display means.   
     
     
         31 . The device of  claim 30 , wherein said tension and pressure force transducers are piezoelectric force transducers. 
     
     
         32 . The device of  claim 27 , further including:
 a cutter connected to said frame, operative to cut at least two suture sections.   
     
     
         33 . The device of  claim 27 , wherein said suture holder is selected from the group consisting of: a pin, a clamp. 
     
     
         34 . The device of  claim 27 , wherein said ultrasonic vibratory energy is between 20 and about 70 kilohertz. 
     
     
         35 . The device of  claim 27 , wherein said ultrasonic vibratory energy transmitter and said suture support member are moved together to apply a compressive force to the sutures for a period longer than the period during which ultrasonic vibratory energy is applied to the sutures. 
     
     
         36 . The device of  claim 35 , wherein the compressive force is applied to the sutures for a period of about 1 second after ultrasonic vibratory energy is stopped. 
     
     
         37 . The device of  claim 35 , wherein the at least two suture sections are flattened from a cylindrical configuration to a flattened configuration, and are expanded in a direction transverse to the central axes of the suture sections. 
     
     
         38 . The device of  claim 27 , wherein a suture retainer is connected to at least two suture sections, and wherein said ultrasonic bonding member bonds the at least two sutures together in association with said suture retainer. 
     
     
         39 . The device of  claim 27 , wherein said frame is a generally cylindrical tube, and said handle is operative to engage fingers of a user. 
     
     
         40 . A method of fastening an object in an animal using ultrasonic vibratory energy, comprising the steps of:
 connecting an elongated object to body tissue;   inserting a portion of the elongated object into a passage formed of a heat moldable material in a fastener body, the fastener body having first and second opposing sides and formed of a heat moldable material;   implanting a therapeutic object having a surface with openings within the body;   contacting the therapeutic object surface with the first side of the fastener body;   pressing an ultrasonic vibratory energy transmitter against the second side of the fastener body;   applying ultrasonic vibratory energy using the transmitter, generating heat in the fastener body whereby the heat moldable material of the passage deforms to closely conform to at least a portion of the object inserted in the passage, and whereby the first side of the fastener body attaches to the therapeutic object;   wherein body tissue is connected to the therapeutic object.   
     
     
         41 . The method of  claim 40 , wherein the therapeutic object is an arthroplasty component. 
     
     
         42 . The method of  claim 40 , wherein the therapeutic object surface is metal. 
     
     
         43 . The method of  claim 40 , wherein the therapeutic object is a joint implant component.