US20080140116A1 - Method and apparatus for securing tissue - Google Patents

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.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application 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
• The present invention relates to a new and improved method and apparatus for securing tissue in a patient's body. The method and apparatus may be utilized to secure hard tissue and/or soft tissue in a patient's body.
BACKGROUND OF THE INVENTION
• Anchors have previously been utilized to retain sutures in a patient'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.
• 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.
• 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
• 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's body. The hard tissue may be any one of the many bones in a patient's body. The soft tissue may be any one of the tissues in a patient's body other than the hard tissue.
• 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.
• 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.
• 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.
• 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's body. The anchor may be moved into the opening formed in the tissue by the pointed leading end portion of the anchor.
• 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
• 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:
• FIG. 1 is an enlarged plan view of an anchor which may be utilized in securing body tissue;
• FIG. 2 is a side elevational view, taken generally along the line2-2 ofFIG. 1, further illustrating the construction of the anchor;
• FIG. 3 is a fragmentary schematic illustration depicting, on a reduced scale, one of the ways in which the anchor ofFIGS. 1 and 2 may be positioned relative to hard and soft body tissue;
• FIG. 4 is a schematic fragmentary illustration depicting one way in which the anchor ofFIG. 3 may connected with body tissue utilizing a retainer connected with a suture;
• FIG. 5 is a fragmentary schematic sectional view, generally similar toFIG. 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;
• FIG. 6 is a fragmentary schematic illustration depicting the manner in which the suture ofFIG. 5 is tensioned with a predetermined force and a connector assembly is utilized to press soft tissue against the bone prior to utilization of the assembly to interconnect sections of the suture;
• FIG. 7 is a schematic illustration depicting the manner in which the anchor ofFIGS. 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;
• FIG. 8 is a schematic sectional view, generally similar toFIG. 7, illustrating the manner in which the anchor and suture cooperate with a retainer to secure the layers of soft body tissue;
• FIG. 9 is a schematic sectional view illustrating the manner in which the anchor and suture ofFIG. 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;
• 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;
• FIG. 11 is a highly schematicized illustration depicting the manner in which the apparatus ofFIG. 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
• FIG. 12 is a highly schematicized illustration of a second embodiment of the apparatus ofFIG. 11.
DETAILED DESCRIPTION OF THE INVENTIONAnchor
• Onespecific anchor20 constructed in accordance with the present invention is illustrated inFIGS. 1 and 2. Theanchor20 may be utilized to secure a suture relative to body tissue in a patient's body. However, it is contemplated that, in some situations at least, theanchor20 may be utilized without a suture.
• Theanchor20 is formed of a single piece of bone, specifically, hard compact bone (cortical bone). The bone from which theanchor20 is formed may be autogenic bone or allogenic bone. Alternatively, theanchor20 may be formed of xenogenic bone.
• Although theanchor20 may be formed of bone obtained from many different sources, it is believed that it may be preferred to form theanchor20 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 theanchor20 could be obtained in any one of many different manners under any one of many different conditions.
• Although it is preferred to form theanchor20 of bone, the anchor may be formed of other materials if desired. Theanchor20 may be formed of biodegradable or non-biodegradable materials. For example, theanchor20 may be formed of polycaperlactone. Theanchor20 may be formed of metal, such as titanium or stainless steel. Alternatively, theanchor20 may be formed of biodegradable or bioerodible copolymers.
• Theanchor20 is formed of a single piece of bone and includes acylindrical body portion22 and apointed end portion24. Thepointed end portion24 has a conical configuration. Thecylindrical body portion22 and pointedend portion24 have a common longitudinalcentral axis28 which extends axially through theanchor20.
• Although thepointed end portion24 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, thepointed end portion24 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.
• It is contemplated that theanchor20 may be used in association with a suture. If and when theanchor20 is to be used with a suture, the anchor is provided with a pair ofpassages30 and32. Thepassages30 and32 have a cylindrical configuration and extend diametrically through thecylindrical body portion22. Central axes of thepassages30 and32 extend parallel to each other and intersect thecentral axis28 of theanchor20.
• Thepassage30 is formed entirely in thebody section22. However, thepassage32 is formed partially in thebody section22 and partially in the pointed end portion34. Thus, the major portion of thepassage32 is formed in thebody portion22. However, a minor portion of thepassage32 extends into thepointed end portion24.
• In the illustrated embodiment of theanchor20, twopassages30 and32 extend diametrically through thecylindrical body portion22 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 thecentral axis28 of theanchor20. Alternatively, the passage could extend axially through the anchor.
• Although it is preferred to provide theanchor20 with the pointed leadingend portion24, it is contemplated that theanchor20 could have a different configuration. For example, theanchor20 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.
• In one specific embodiment of theanchor20, intended for use with a suture, the anchor had an overall length of approximately 0.236 inches and abody portion22 with a diameter of approximately 0.072 inches. Thepassages30 and32 had diameters of approximately 0.035 inches. Another embodiment of theanchor20 had an overall length of approximately 0.354 inches and abody portion22 with a diameter of approximately 0.119 inches. Thepassages30 and32 in the specific anchor had a diameter of approximately 0.046 inches.
• It should be understood that the foregoing dimensions of specific embodiments of theanchor20 have been set forth herein for purposes of clarity of description. It is contemplated that theanchor20 will be formed with dimensions which are different than these specific dimensions. For example, ananchor20 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.
• The specific embodiment of theanchor20 described herein is formed of bone. Specifically, theanchor20 is formed of a single piece of human bone. However, theanchor20 may be formed of other materials if desired. For example, theanchor20 may be formed of titanium or titanium alloys. Alternatively, theanchor20 may be formed of stainless steel. Theanchor20 may be formed of any one of many known biodegradable materials. Theanchor20 may be formed of either biodegradable or nonbiodegradable polymeric materials.
Positioning of Anchor Relative to Body Tissue
• Theanchor20 ofFIGS. 1 and 2 may be utilized to secure a suture36 (FIG. 3) relative to body tissue. Thesuture36 may be formed of a plastic material which is a biopolymer. In one specific embodiment of the invention, thesuture36 is formed of polyglycolide which is commercially available under the trademark DEXON. Polyglycolide is a crystalline material that melts at about 225° Celsius. Although thesuture36 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, thesuture36 could 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.
• It is also contemplated that thesuture36 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. Thesuture36 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.
• The strength of thesuture36 will vary as a function of 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.
• 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.
• In the embodiment of the invention illustrated inFIG. 3, theanchor20 is utilized with asuture36. Thespecific anchor20 illustrated inFIG. 3 is integrally formed as one piece of freeze dried human bone. Theanchor20 andsuture30 are utilized to holdsoft body tissue40 against movement relative to a portion of abone44 in a human patient's body. Thetissue40 is connective tissue, such as a ligament or tendon. However, thetissue40 could be other types of tissue if desired.
• When thetissue40 is to be connected with thebone44, theanchor20 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 thebone44 with theanchor20, a hardouter surface48 is removed from a compactouter layer50 of bone by a decortation process. The decortation process is performed by abrading the hardouter surface48 on the compactouter layer50 of hard cortical bone to expose an imperforateinner area52 at a location where theanchor20 andsuture36 are to be utilized to connect thebody tissue40 with thebone44. Once the decortation process has been completed, thesoft body tissue40 is positioned in engagement with theinner area52 in the manner illustrated schematically inFIG. 3. The decortation process is optional and may be omitted if desired.
• Theanchor20 is then moved through thebody tissue40 into thebone44. It is believed that it will be preferred to move theanchor20 into thebone44 under the influence of an axial force applied against a trailing end portion of the anchor. Since the bone forming theanchor20 has a relatively high compressive strength, the anchor can be utilized to transmit relatively large forces along the longitudinal central axis28 (FIG. 1) of the anchor to force the anchor into thebone44. However, bone has a relatively low tensile strength and can not transmit large transverse loads. Therefore, when theanchor20 is moved into thebone44 under the influence of axial force applied against a 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.
• In order to support theanchor20 during movement of the anchor into thebone44, the anchor is advantageously inserted into a tubular cylindrical metal sleeve or member58 (FIG. 3). Acylindrical pusher member60 is received in thecylindrical sleeve58 and is utilized to apply an axial force to a circular trailingend surface62 on theanchor20. Although the sleeve andpusher member58 and60 could have many different configurations and cooperate with each other in many different manners, it may be preferred to utilize asleeve58 andpusher member60 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 theanchor20 into thebody tissue40 andbone44 if desired.
• When the anchor is to be moved through thebody tissue40 into thebone44, thepointed end portion24 of the anchor is aligned with thebody tissue40 at a location where the anchor is to be moved into the body tissue. Thesleeve58 is then pressed firmly against thebody tissue40. Although a substantial space has been shown between the inner surface of thesleeve58 and the cylindrical outer side surface of theanchor20 inFIG. 3 for purposes of clarity of illustration, it is contemplated that there will be a relatively snug fit of theanchor20 andpusher member60 with the inner side surface of thesleeve58. However, theanchor20 andpusher member60 will be freely movable in an axial direction along thesleeve58.
• Thepusher member60 is then pressed firmly against the trailingsurface62 on theanchor20. This force easily moves the pointed leadingend portion24 of theanchor20 through thesoft body tissue40 into engagement with an imperforate surface area on the compactouter layer50 of thebone44.
• Theanchor20 is moved out of thetubular sleeve58 into the compactouter layer50 of thebone44 at a location which is free of naturally occurring openings (FIG. 3). To move theanchor20 out of thesleeve58 into thebone44, the pusher member applies an axial force against the trailingend surface62 on theanchor20. The axial force applied by thepusher member60 moves the pointed leadingend portion24 of the anchor into the compactouter layer50 of bone. Thetubular sleeve58 engages the cylindrical outer side surface of theanchor20 to support the anchor against sidewise loading. This results in the anchor being subjected primarily to compressive force as the anchor is moved into thebone44.
• As theanchor20 moves into thebone44, the material of the compactouter layer50 of the bone is displaced sideways by theleading end portion24 of theanchor20. As theanchor20 continues to move into the compactouter layer50 of thebone44, the material of the compact outer layer supports the anchor against transverse loading in much the same manner in which thetubular sleeve58 supports the anchor. Therefore, thepusher member60 can apply relatively large axial force to theanchor20 without failure, that is, without fracture or buckling of the anchor.
• Theanchor20 is utilized to initiate formation of an opening in the compactouter layer50 of thebone44 at a location which is free of openings. However, if desired, a relatively small pilot opening could be drilled through the compactouter layer50 of thebone44. Theanchor20 would then be utilized to form the small pilot opening into a larger opening through which the anchor can pass.
• Theanchor20 is moved through a desired distance into thebone44. In order to facilitate determination of when theanchor20 is moved through the desired distance into thebone44, indicia may be provided on thepusher member20. The indicia on thepusher member60 cooperates with thesleeve58 to indicate when theanchor20 has moved through a desired distance into thebone44. The application of force against theanchor20 by thepusher member36 is then interrupted. The manner in which thesleeve58 andpusher member60 cooperate with theanchor20 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 and hereby is incorporated herein in its entirety.
• It is contemplated that theanchor20 may be utilized, without thesuture36, to connect thebody tissue40 with thebone44. When theanchor20 is to be used in this manner, theanchor20 will engage both thebody tissue40 and thebone44. However, the illustrated embodiment of theanchor20 is intended for use with thesuture36.
• Thepusher member60 is effective to push theanchor20 through the compactouter layer50 of hard cortical bone into relatively softcancellous bone66 which is enclosed by the hard compactouter layer50. As the pointed leadingend portion24 of theanchor20 enters thecancellous bone66, the pointed end portion pushes thecancellous bone66 aside to form an opening in the cancellous bone. The anchor moves into thecancellous bone66 along a straight path having a longitudinal axis which is coincident with a longitudinal central axis of thesleeve58. Therefore, thepointed end portion24 of the anchor is effective to push aside tissue forming the compactouter layer50 and thecancellous bone66 as the anchor moves into thebone44.
• When the anchor has moved through a predetermined distance into thecancellous bone66, the anchor is pivoted from the orientation illustrated inFIG. 3 to the orientation illustrated inFIG. 4. Thus, after theend surface62 on theanchor20 has moved past the inner side surface of the compactouter layer50 and into thecancellous bone66, the orientation of theanchor20 relative to thebone44 is changed by rotating the anchor through ninety degrees (90°) with a toggling action.
• To initiate the toggling action, asection70 of thesuture36 extending through theanchor passage32 to a location outside of the bone is tensioned. At this time, asecond section72, which extends through theanchor passage30, is relaxed. There is enough friction between thesection70 of the suture and the freeze-dried bone forming theanchor20 to initiate a pivoting action of the anchor.
• Once this pivoting action has been initiated, the pusher member60 (FIG. 3) is pressed against a circular rim on theend surface62 and the tension in thesection70 of the suture is increased. As the tension in thesection70 of the suture is increased, the suture tends to slide relative to the material forming theanchor20. Therefore, the tension in thesection72 of thesuture36 is increased. However, the tension in thesection70 of the suture will tend to be larger than the tension in thesection72 of the suture.
• Once theanchor20 begins to rotate with a toggling action, thepusher member60 is pressed against the rim of theend surface62 to maintain the anchor at the desired depth in thecancellous bone66. At the same time, the tension in thesections70 and72 of thesuture36 applies torque to the anchor to rotate the anchor about the location where the anchor engages thepusher member60. Theanchor20 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.
• Once theanchor20 has pivoted to the orientation illustrated inFIG. 4, thesections70 and72 of thesuture36 can be freely moved in thepassages32 and30 extending through the anchor. This enables thesections70 and72 of thesuture36 to be moved relative to each other so that they have the desired length.
• Theanchor20 is supported in thecancellous bone66 in a spaced-apart relationship with the compactouter layer50 of bone. Theanchor20 is entirely surrounded by a matrix of thecancellous bone66. Theanchor20 does not touch the compactouter layer50 of bone. Tension forces applied to theanchor20 by thesuture36 are transmitted from the outer side surface of the anchor to the cancellous bone to hold the anchor against movement relative to thebone44.
• Thesuture36 extends through anopening78 in the compactouter layer50 of bone into thesoft body tissue40. The suture extends through the soft body tissue to a location disposed on a side of the soft body tissue opposite from thebone44. Thesuture36 extends through thebody tissue40 along the same path which the anchor was moved through thebody tissue40 from the position shown inFIG. 3 to the position shown inFIG. 4. The viscoelastic nature of thesoft body tissue40 results in closing of the opening formed in thebody tissue40 by passage of theanchor20 through the body tissue. However, thesections70 and72 of the suture remain in the closed passage through thebody tissue40 along which theanchor20 previously moved.
• Thesuture36 may be connected with the soft body tissue in any one of many different ways. In the embodiment of the invention illustrated inFIG. 4, aretainer82 is connected with thesections70 and72 of thesuture36. Although thesections70 and72 of thesuture36 could extend straight through theretainer82, it is preferred to form a plurality of bends in the suture by wrapping the suture around a portion of the retainer.
• The illustratedretainer82 has a spherical configuration with a cylindrical passage which extends diametrically through the center of the retainer. Thesections70 and72 of thesuture36 may be wrapped around theretainer82 and passed through the passage through the retainer a plurality of times. Thus, thesection70 of thesuture36 extends through the passage in theretainer82, around the outer side surface of the retainer and back through the passage again. Thesection72 of thesuture36 also extends through the passage in theretainer82, around the outside of the retainer and back through the passage in the retainer. If desired, theretainer82 could have a different configuration and thesuture36 could be connected with the retainer in a different manner if desired.
• After thesuture36 has been inserted through theretainer82, theretainer82 is moved along thesections70 and72 of the suture toward thebody tissue40. As theretainer82 is moved along thesections70 and72 of thesuture36 toward thebody tissue40, the retainer moves into engagement with the body tissue. Thesections70 and72 of thesuture36 are then tensioned with a predetermined force. This predetermined tension force is transmitted through theretainer82 to theanchor20. At the same time, theretainer82 is pressed downward against thebody tissue40 with a predetermined force.
• This results in thesoft body tissue40 being compressed against theinner area52 on the compactouter layer50 of bone with a predetermined force while a predetermined tension force is transmitted through thesuture36 to theanchor20. In this manner, a desired force, which has been preselected as a function of the size of thesuture36 and the characteristics of thesoft body tissue40 andbone44 is applied against the body tissue and the bone by theanchor20 andretainer82. Although theretainer82 applies force against a far greater surface area on thesoft body tissue40 than would be engaged by a knot in thesuture36, a force distribution member or button may be placed between theretainer82 and the upper surface of the soft body tissue.
• Once theretainer82 has been moved along thesuture36 and is being pressed against thesoft body tissue40 with a predetermined force while a predetermined tension is maintained in thesections70 and72 of thesuture36, thesuture retainer82 is connected with thesuture36. Thesuture retainer82 may be connected with thesuture36 in any one of many different ways. However, theretainer82 is connected with thesuture36 by plastically deforming the retainer to effect a cold flowing of material of the retainer.
• Force is applied against opposite sides of theretainer82 by a pair of force application members with a clamping action. This force is effective to cause flowing of the material of theretainer82 at a temperature below a transition temperature range for the material of the retainer. The cold flowing of the material of theretainer82 results in a collapsing of the passage through the retainer and a flowing of the material of the retainer around thesections70 and72 of the suture. This enables the material of theretainer82 to bond to and obtain a firm grip on thesuture36. The cold flowing of the material of theretainer82 occurs at a temperature which is below the transition temperature of the material forming the retainer.
• As the material of theretainer82 is deformed, the material of the retainer bonds to thesuture36. When thesuture36 is of the cable type and formed by a plurality of interconnected filaments or strands, the material of theretainer82 flows around and between the strands. The material of theretainer82 flows completely around portions of each individual strand and bonds to each individual strand. In addition, the material of theretainer82 flows around the intertwined suture strands and bonds to them as a group. Of course, if thesuture36 is a monofilament, the material of the retainer bonds to only the single strand or filament.
• Theretainer82 may be formed of many different materials. However, it is believed that it will be preferred to form theretainer82 of a biodegradable polymer. Once biodegradable polymer which may be utilized is polycaperlactone. Alternatively, theretainer82 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 thesuture36 of the same material as theretainer82. Thus, thesuture36 could be formed of any one of the materials previously suggested for forming theretainer82.
• It is preferred to effect the cold flowing of the material of thesuture retainer82 without the addition of heat. However, it is contemplated that thesuture retainer82 could be heated to a temperature which is somewhat above the temperature of thebody tissue40. If desired, heat could be transmitted to theretainer82 through force application members which effect plastic deformation of the material of the retainer. When thesuture36 has a plurality of twisted strands, flowing of the material of theretainer82 around the strands of the suture is promoted by heating of the retainer.
• The construction of theretainer82 and the manner in which it cooperates with thesuture36 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 “Method 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.
• Although onespecific retainer82 has been described in connection with the embodiment of the invention illustrated inFIG. 4, it is contemplated that theretainer82 could have a different construction if desired. For example, theretainer82 could have any one of the constructions disclosed in the aforementioned application Ser. No. 09/523,442. Alternatively, theretainer82 could have a different known construction.
Embodiment of FIGS. 5 and 6
• In the embodiment of the invention illustrated inFIGS. 1-4, thesections70 and72 of thesuture36 extend through thebody tissue40 and are connected with aretainer82. In the embodiment of the invention illustrated inFIGS. 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 inFIGS. 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 inFIGS. 5 and 6 is similar to the embodiment of the invention illustrated inFIGS. 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 inFIGS. 1-4 may be used with the embodiment of the invention illustrated inFIGS. 5 and 6.
• An anchor100 has the same construction as theanchor20 ofFIGS. 1 and 2. The specific anchor100 ofFIGS. 5 and 6 is integrally formed as one piece of freeze dried human bone. The anchor100 is inserted through soft body tissue in the same manner as was previously described in conjunction with the embodiment of the invention illustrated inFIGS. 3 and 4. In addition, the anchor100 was moved through a compactouter layer104 of abone106 intocancellous bone108 in the same manner as was previously described in connection withFIGS. 3 and 4. The anchor100 is supported in thecancellous bone108 in a spaced-apart relationship with the compactouter layer104 of thebone106.
• Asuture110 extends through passages in the anchor100. Thesuture110 may have either a cable-like or a monofilament construction. Thesuture110 may be a cable having strands formed of any of the materials mentioned in conjunction with thesuture36 ofFIGS. 3 and 4. However, the illustratedsuture110 is a monofilament having a continuous cylindrical outer side surface.
• Sections112 and114 of thesuture110 are pulled through thesoft body tissue102 and into thebone106 as the anchor100 is inserted into the bone in the manner previously explained in conjunction with the embodiment of the invention illustrated inFIG. 3. However, in the embodiment of the invention illustrated inFIGS. 5 and 6, it is desired to have one of the sections of the suture extend around the outside of thesoft body tissue102 while the other section of the suture extends through the body tissue. Thus, a gripper, illustrated schematically at118 inFIG. 5, grips thesection114 of thesuture110 and pulls thesection114 of the suture out of thesoft body tissue102 after the anchor100 has been positioned in thecancellous bone108. Although thesection114 of thesuture110 is withdrawn from thesoft body tissue102, thesection112 of the suture remains extending through the soft body tissue in the manner illustrated schematically inFIG. 5. Thesection114 of thesuture110 is wrapped around the outside of the body tissue and pulled into engagement with thesection112 of the suture.
• Once thesections112 and114 of thesuture110 have been positioned relative to thebody tissue102, thesections112 and114 of the suture are tensioned with a predetermined force. At the same time, thesoft body tissue102 is pressed against the hard compactouter layer104 of thebone106 with a predetermined force. The twosections112 and114 of thesuture110 are then connected with each other to hold thesoft body tissue102 in a desired relationship with thebone106. If desired, a force distribution member, such as a button, may be provided between thesuture110 and thesoft body tissue102.
• Anapparatus120 for tensioning the twosections112 and114 of thesuture110 has been illustrated schematically inFIG. 6. Theapparatus120 includes a pair of rotatable wheels orpulleys122 and124. The rotatable wheels orpulleys122 and124 are connected to force measurement transducers which have an output which is proportional to the sideward force applied to the wheels. Thus, when thesuture section112 is tensioned, a leftward force (as viewed inFIG. 6) is applied to therotatable wheel122. A transducer connected with thewheel122 is effective to provide an output signal which varies as a function of the leftward force applied to thewheel122 by thesuture112. Of course, as the tension in the suture increases, the sideward force applied against thewheel122 increases.
• 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 acontroller128.
• Similarly, thewheel124 is connected with a force measuring transducer. The force measuring transducer connected with thewheel124 has an output which varies as a function of the force applied against thewheel124 by thesection114 of the suture as the suture is tensioned. The output from the transducer connected with thewheel124 is also transmitted to thecontroller128.
• When the output from the transducers indicates that the desired tension is present in thesections112 and114 of thesuture110, clamps132 and134 are activated to hold thewheels122 and124 against rotation and to hold thesections112 and114 of thesuture110 against movement relative to the wheels. For example, thesuture section112 is manually pulled and thewheel122 rotated until the output from the transducer connected with the wheel indicates that a desired tension is present in the section of the suture. Thecontroller128 then activates theclamp132 to hold both thewheel122 and thesection112 of the suture against movement. This results in the desired tension being maintained in thesection112 of the suture. Similarly, when the output from the transducer connected with thewheel124 indicates to thecontroller128 that the desire tension is present in thesection114 of the suture, theclamp134 is activated to clamp thewheel124 andsuture section114 against movement.
• In response to detecting that the desired tension is present in bothsections112 and114 of thesuture110, thecontroller128 activates a connector assembly140 (FIG. 6) to press thesoft body tissue102 against thebone106 with a predetermined force. In response to detecting that the desired tension is present in thesections112 and114 of the suture and that thesoft body tissue102 is being pressed against thebone106 with a desired force, thecontroller128 affects operation of theconnector assembly140 to connect thesections112 and114 of thesuture110 together.
• When the controller detects that the desired tension is present in thesections112 and114 of thesuture110, the controller activates an actuator (not shown) to pressmembers142 and144 in theconnector assembly140 downward against thebody tissue102 with a predetermined force. While thebody tissue102 is being urged downward with a predetermined force and while a desired tension is being maintained in thesections112 and114 of thesuture110, theconnector assembly140 is operated to interconnect thesections112 and114 of the suture. Thesections112 and114 of the suture may be interconnected with a retainer having the same construction as theretainer82 ofFIG. 4. Alternatively, thesections112 and114 of the suture may be bonded together. Regardless of how the suture sections are interconnected, a force distribution member may be provided.
• To effect a bonding of thesections112 and114 of the suture together, the member142 functions as an anvil and themember144 functions as a horn to press the twosections112 and114 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 thesections112 and114 of the suture against each and to apply ultrasonic vibratory energy to the sections of the suture, the anvil142 is pressed against one side of thesuture sections112 and114. Thehorn144 is pressed against the opposite side of thesuture sections112 and114.
• The specific force with which the horn andanvil144 and142 are pressed against opposite sides of thesuture sections112 and114 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 thesuture sections112 and114 have been heat softened by ultrasonic vibratory energy, the material of thesuture sections112 and114 is pliable. The material of thesuture sections112 and114 then is plastically deformed by the force applied against the suture sections by the anvil142 andhorn144.
• In addition to the anvil142 andhorn144, the apparatus for transmitting ultrasonic vibratory energy to thesuture sections112 and114 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 vibrations. The vibrations are then transmitted to thehorn144.
• The ultrasonic vibratory energy transmitted to thesuture sections112 and114 from thehorn144 is converted into heat energy. When this occurs, the temperature of the material forming the portions of thesuture sections112 and114 adjacent to thehorn144 increases. As the temperature of thesuture sections112 and114 increases, the material of the suture sections is heated into the lower end portion of a transition temperature range. As the material of thesuture sections112 and114 is heated into the transition temperature range, the material softens and becomes pliable. However, the material of thesuture sections112 and114 does not melt and retains sufficient strength to enable the desired tension to be transmitted through the suture sections.
• The somewhat softened material of the heated portions of thesuture sections112 and114 are pressed together and bond to each other. The materials of thesuture sections112 and114 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.
• One known source of devices for effecting an ultrasonic bond is Dukane Corporation, Ultrasonics Division, 2900 Dukane Drive, St. Charles, Ill. 60174. Theconnector assembly140 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 “Method 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.
Embodiment of FIGS. 7 and 8
• In the embodiments of the invention illustrated inFIGS. 1-6, the anchor has been utilized to secure a suture relative to a bone in a human patient's body. In the embodiment of the invention illustrated inFIGS. 7 and 8, an anchor is utilized to secure a suture relative to soft body tissue in a human patient's body. Since the embodiment of the invention illustrated inFIGS. 7 and 8 is similar to the embodiment of the invention illustrated inFIGS. 1-6, similar terminology will be utilized to identify similar components.
• In the embodiment of the invention illustrated inFIGS. 7 and 8, a relatively thick layer of soft body tissue, designated bynumeral150, and a thin layer of soft body tissue, designated bynumeral152, are to be interconnected by atissue securing system154. The tissue securing system154 (FIG. 8) includes ananchor158 which is connected with aretainer160 by asuture162. Although only a single tissue securing system has been disclosed in association with thelayers150 and152 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 “Method of Using Ultrasonic Vibration to Secure Body Tissue”.
• Theanchor158 has the same construction as theanchor20 ofFIGS. 1 and 2. Theanchor158 is integrally formed as one piece of freeze dried human bone. Thesuture162 has the same construction as thesuture36 ofFIGS. 3 and 4. Thesuture162 has a cable-like construction with a plurality of interconnected strands formed of the materials previously mentioned in conjunction with thesuture36. Thesuture162 has asection166 which extends from a passage168 (FIG. 7) in theanchor158. In addition, thesuture162 has asection170 which extends from apassage172 in theanchor158.
• When theanchor158 is to be positioned relative to thelayers150 and152 of soft body tissue, a pointed leadingend portion176 is positioned in engagement with one of the layers of body tissue. At this time, a central axis of theanchor158 extends perpendicular to thelayer152 of body tissue. In the embodiment of the invention illustrated inFIG. 7, theanchor158 is positioned in engagement with an imperforate surface area on thethin layer152 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, theanchor158 would initially be positioned in engagement with an imperforate surface area on thethick layer150 of body tissue.
• Once theanchor158 has been positioned relative to thelayer152 of body tissue, a force, indicated schematically at180 inFIG. 7, is applied against a trailing end of the anchor. Theforce180 is effective to push the hard cortical bone of theanchor158 through the twolayers152 and150 of body tissue. Thus, theforce180 initially presses the pointed leadingend portion176 of theanchor158 against thethin layer152 of body tissue. As theanchor158 moves into the body tissue under the influence of theforce180, the anchor initiates the formation of an opening in thelayer152 of body tissue at a location which is free of openings. The pointedleading end portion176 of the anchor deflects body tissue sideways to initiate formation of an opening in thelayer152.
• Continued movement of theanchor158 into thelayer152 of body tissue moves theleading end portion176 of the anchor into engagement with an imperforate surface on the second or lower (as viewed inFIG. 7)layer150 of body tissue. Theleading end portion176 of theanchor158 penetrates thelayer150 of body tissue and initiates the formation of an opening under the influence of the continuingforce180. As the anchor moves through the body tissue, the trailing end portion of the anchor moves out of the lower (as viewed inFIG. 7)layer150 of body tissue. The viscoelastic material of the body tissue resiliently closes behind theanchor158 as it passes through the body tissue. This results in thelayers150 and152 of body tissue engaging the twosections166 and170 of the suture.
• The pointedleading end portion176 of theanchor158 is effective to form openings in thelayers150 and152 of body tissue at locations which were previously free of openings. Thus, theleading end portion176 of theanchor158 moves into engagement with an imperforate surface area on an upper or outer side of thethin layer152 of body tissue and initiates the formation of an opening in the body tissue. Similarly, as theanchor158 engages the upper side surface of thelower layer150 of body tissue, the pointed leadingend portion176 initiates the formation of an opening at an imperforate surface area on the lower layer of body tissue. The openings formed by theanchor158 as it moves through thelayers150 and152 of body tissue is closed behind the anchor due to the viscoelastic nature of the body tissue.
• Theanchor158 can be moved through thelayers150 and152 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 thesleeve58 andpusher member60 ofFIG. 3. The inserter assembly for moving theanchor158 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.
• Once theanchor158 has been moved through thelayers150 and152 of body tissue, thesection166 of thesuture162 is tensioned. Theanchor158 and thelayers150 and152 of body tissue apply sufficient friction against thesection170 of thesuture162 that tensioning thesection166 of the suture is effective to apply a torque to the anchor which rotates it from the orientation illustrated inFIG. 7 to the orientation illustrated inFIG. 8. When theanchor158 is in the orientation illustrated inFIG. 8, the central axis of the anchor extends generally parallel to the major side surfaces of thelayers150 and152 of body tissue. At this time, the twosections166 and170 of the suture can be tensioned and freely moved relative to the anchor to adjust the relative lengths of thesections166 and170 of the suture.
• Thesections166 and170 of the suture are connected with theretainer160 in the same manner as previously explained in conjunction with theretainer82 inFIG. 4. In the illustrated embodiment of theretainer160, the retainer has a spherical configuration with a cylindrical central passage. However, it is contemplated that theretainer160 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, theretainer160 could have a configuration corresponding to the configuration of any other known retainer.
• When thesuture162 has been positioned relative to the retainer, the suture is tensioned with a predetermined tension force. Theretainer160 is then moved along thesections166 and170 of the suture and pressed against thelayers152 and150 of body tissue with a predetermined force. If desired, a force distribution member such as a button, could be provided between theretainer160 and thelayer152 of body tissue. Another force distribution member could be provided between theanchor158 and thelayer150 of body tissue.
• While the predetermined tension is maintained in thesuture162 and while theretainer160 is urged toward the body tissue with a predetermined force, theretainer160 is fixedly connected with thesuture162. Theretainer160 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, theretainer160 may be connected with thesuture162 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
• In the embodiment of the invention illustrated inFIGS. 7 and 8, atissue securing system154 is utilized to interconnectlayers150 and152 of body tissue. Aretainer160 is associated with a suture to apply a predetermined force against thelayers150 and152 of body tissue and to maintain a predetermined tension in thesections166 and170 of the suture. In the embodiment of the invention illustrated inFIG. 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 inFIG. 9 is similar to the embodiments of the invention illustrated inFIGS. 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 inFIGS. 1-8 could be utilized in association with the embodiment of the invention illustrated inFIG. 9.
• In the embodiment of the invention illustrated inFIG. 9, soft tissue layers180 and182 are disposed in linear apposition with each other. Atissue securing system184 is utilized to interconnect thelayers180 and182 of soft human body tissue. Thetissue securing system184 includes ananchor188 and asuture190. Theanchor188 has the same construction as theanchor20 ofFIGS. 1 and 2. Thespecific anchor188 illustrated inFIG. 9 is formed as one piece of freeze dried human bone. Thesuture190 has the same construction as thesuture36 ofFIGS. 3 and 4.
• Thesuture190 is connected with the anchor in the same manner as previously described in conjunction with the embodiment of the invention illustrated inFIGS. 7 and 8. Thesuture190 hassections192 and194 which extend frompassages196 and198 through thelayers180 and182 of body tissue. In the embodiment of the invention illustrated inFIG. 9, a force distribution member orbutton196 is provided adjacent to the upper (as viewed inFIG. 9) major side surface of thelayer180 of tissue. Theforce distribution member198 distributes force transmitted from thesuture190 over a relatively large area on thelayer180 of tissue.
• The twosections192 and194 of the suture are tensioned with a predetermined tension force. Theforce distribution member196 is pressed against thelayer180 of body tissue with a predetermined force. While the predetermined tension is maintained in thesuture190 and while theforce distribution member196 is pressed against thelayer180 of tissue with a predetermined force, the twosections192 and194 of thesuture190 are bonded to each other by aconnector assembly200.
• Theconnector assembly200 may have the same construction as previously described in conjunction with the embodiment of the invention illustrated inFIG. 6. Of course, theconnector assembly200 may have a construction which is different than the construction of theconnector assembly140 ofFIG. 6. If desired, the twosections192 and194 of thesuture190 may be tensioned with a predetermined force by an apparatus having the same construction as theapparatus120 ofFIG. 6. It should be understood that the twosections192 and194 of thesuture190 may be tensioned in a different manner if desired. For example, thesuture sections192 and194 could be manually tightened without using theapparatus120 ofFIG. 6.
• Theconnector assembly200 includes ananvil202 which is pressed against one side of thesections192 and194 of thesuture190. Ahorn204 is pressed against the opposite sides of thesections192 and194 of thesuture190. While the horn andanvil202 and204 are being pressed against opposite sides of thesections192 and194 of thesuture190, ultrasonic vibratory energy is transmitted from thehorn204 to at least one of the sections of the suture. The ultrasonic vibratory energy transmitted from thehorn204 to thesections192 and194 of thesuture190 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.
• When the sections of the suture have been heated into their transition temperature range, they are bonded to each other. The extent to which thesections192 and194 of thesuture190 are heated is sufficient to soften the material of the suture. However, thesections192 and194 of the suture are not heated to a temperature which is so great as to impair the strength of thesuture190. This enables the desired tension force to continue to be transmitted through thesections192 and194 of thesuture190 as they are bonded to each other by theanvil202 and horn204 of theconnector assembly200. The manner in which theconnector assembly200 interconnects thesections192 and194 of thesuture190 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
• In the embodiments of the invention illustrated inFIGS. 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 inFIGS. 10 and 11. Although the apparatus ofFIGS. 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 inFIGS. 10 and 11 is similar to the embodiments of the invention illustrated inFIGS. 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 inFIGS. 1-9 may be used with the embodiment of the invention illustrated inFIGS. 10 and 11.
• An apparatus220 (FIGS. 10 and 11) is utilized to secure a suture222 (FIG. 11) relative to body tissue. Thesuture222 may have the same construction as thesuture36 ifFIGS. 3 and 4. Thespecific suture222 is a cable with a plurality of interconnected strands or filaments. However, thesuture222 could be formed of a single strand if desired.
• In the embodiment of the invention illustrated inFIG. 11, the body tissue includessoft body tissue224 andbone226. Thebone226 includes a compactouter layer228 which enclosescancellous bone230. Although theapparatus220 has been illustrated inFIG. 11 in association withsoft body tissue224 andbone226, it is contemplated that theapparatus220 could be utilized in association with just soft tissue in the manner illustrated inFIG. 8. Alternatively, theapparatus220 could be utilized with just hard tissue. Thus, theapparatus220 could be utilized with fragments of a bone or with separate bones if desired.
• Theapparatus220 includes a housing234 (FIG. 10). InFIG. 11, the housing has been omitted and the apparatus enclosed by the housing has been illustrated schematically. The apparatus220 (FIG. 11) includes asuture tensioning assembly238. Thesuture tensioning assembly238 is operable to tension thesuture222 with a predetermined tension force.
• Theapparatus220 also includes a force application assembly242 (FIG. 11). Theforce application assembly242 is operable to apply a predetermined force to aretainer244 to urge the retainer toward thesoft body tissue224 andbone226. Thesuture tensioning assembly238 is disposed in the upper end portion of the housing234 (FIG. 10) and theforce application assembly242 is disposed in the lower end portion of the housing.
• A connector assembly248 (FIG. 11) is provided in the lower end portion of thehousing234 adjacent to theforce application assembly242. Theconnector assembly248 is operable to connect theretainer244 with thesuture242. A predetermined tension force is applied to thesuture242 by thesuture tensioning assembly238 and a predetermined force is transmitted from theforce application assembly242 through theretainer244 to thesoft body tissue224 andbone226 when theconnector assembly248 is operated to connect the retainer with the suture.
• A trimmer assembly252 (FIG. 11) is provided in the housing234 (FIG. 10). Thetrimmer assembly252 is disposed between thesuture tensioning assembly238 and forceapplication assembly242. Thetrimmer assembly252 is operable to sever thesuture222 after theconnector assembly248 has connected theretainer244 with the suture and while the predetermined tension is present in the suture and a predetermined force is being transmitted from the retainer through thebody tissue224.
• Operation of theconnector assembly248 andtrimmer assembly252 is controlled by a microprocessor orcontroller256. Thecontroller256 detects when the predetermined tension is present in thesuture222 and when the predetermined force is transmitted through theretainer244 to thesoft body tissue224 andbone226. In response to detection of the predetermined tension in thesuture222 and the transmission of the predetermined force to theretainer244, thecontroller256 initiates operation of theconnector assembly248 to connect theretainer244 with thesuture222. Immediately thereafter, thecontroller256 effects operation of thetrimmer assembly252 to sever thesuture222.
• In the embodiment of the invention illustrated inFIGS. 10 and 11, the controller256 (FIG. 11) effects operation of theconnector assembly248 when both a predetermined tension is present in thesuture222 and a predetermined force is being transmitted through the retainer to thebody tissue224 andbone226. However, it is contemplated that theapparatus220 could be constructed in such a manner as to have thecontroller256 effect operation of theconnector assembly248 in response to only detection of a predetermined tension in thesuture222. Alternatively, thecontroller256 could effect operation of theconnector assembly248 in response to only detection of transmission of a predetermined force to theretainer244 andbody tissue224.
• In the embodiment of the invention illustrated inFIGS. 10 and 11, the controller256 (FIG. 11) is spaced from the housing234 (FIG. 10). Thecontroller256 is connected with the apparatus disposed in the housing through acable258. However, it is contemplated that thecontroller256 could, if desired, be mounted on or in thehousing234.
• In the embodiment of the invention illustrated inFIG. 11, thesuture222 is connected with ananchor260 which is embedded in thecancellous bone230 in a spaced apart relationship with the compactouter layer228 of thebone226. Theanchor260 has the same construction as theanchor20 ofFIGS. 1 and 2.Sections262 and264 of thesuture222 extend from passages in the anchor through the compactouter layer228 of thebone226 and thesoft body tissue224 to theretainer244. Thesections262 and264 of thesuture222 extend through theforce transmission assembly242 andtrimmer assembly252 to thesuture tensioning assembly238.
• Although thesuture222 is connected with theanchor260 in the embodiment of the invention illustrated inFIG. 11, it is contemplated that thesuture222 could be connected with body tissue in a manner other than through the use of theanchor260. For example,suture222 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 et al. and entitled “Method and Apparatus for Securing a Suture”.
• Of course, thesuture222 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 theapparatus220 will be utilized in association with sutures which are connected with many different types of body tissue in many different ways.
• Thesuture tensioning assembly238 is operable to tension thesuture222 with at least a predetermined tension force. Thesuture tensioning assembly238 includes a circularupper member270 having an opening through which thesections262 and264 of thesuture222 extend. Theupper member270 is movable downward relative to thehousing234 from the uppermost position illustrated inFIG. 10. Although theupper member270 can move downward from the position shown inFIGS. 10 and 11, the upper member can not move upward from the position shown inFIGS. 10 and 11.
• Thesections262 and264 of thesuture222 are fixedly secured to theupper member270. In the embodiment of the invention illustrated inFIG. 11, apin272 extends upward from theupper member270. Thesections262 and264 of thesuture222 are tied to thepin272.
• It should be understood that thesections262 and264 of thesuture222 could be connected with theupper member270 in a different manner if desired. For example, thesections262 and264 of the suture could be locked in a V-shaped slot formed in theupper member270. Alternatively, a gripper assembly could be provided on theupper member270 to grip thesections262 and264 of the suture.
• A circularlower member276 in the suture tensioning assembly238 (FIG. 11) is connected with theupper member270 by a plurality of springs which have been illustrated schematically at278 inFIG. 11. Thelower member276 is movable relative to thehousing234. Thelower member276 can only move upward from the position shown inFIGS. 10 and 11. When thelower member276 moves upward, thesprings278 are compressed.
• A pair of manuallyengageable handles282 and284 (FIG. 10) are fixedly connected with diametrically opposite sides of the cylindricallower member276. Thehandles282 and284 extend through slots in thehousing234 and are readily engaged by fingers on the hand of a surgeon during use of theapparatus220. Thehandles282 and284 can be manually moved upward (as viewed inFIG. 10) to move thelower member276 upward relative to thehousing234. Thehandles282 and284 are engagable with lower ends of the slots in the housing to block downward movement of thelower member276 from the position shown inFIG. 11.
• In order to tension thesuture222, thesections262 and264 of the suture are first tied off at thepin272. As thesections262 and264 of thesuture222 are tied off at thepin272, an initial tension force is transmitted from the suture to theupper member270. This initial tension force moves theupper member270 downward and slightly compress thesprings278. Thehandles282 and284 are pressed against lower ends of the slots in thehousing234 to resist the initial tension force.
• Fingers on one hand of the surgeon then apply an upwardly directed force against thehandles282 and284. This upwardly directed force is applied against the springs278 (FIG. 10) by thelower member276. The upwardly directed force is transmitted through thesprings278 to theupper member270 and thesections262 and264 of thesuture222. As the force applied against thehandles282 and284 (FIG. 10) is increased, thesprings278 are compressed and the tension in thesections262 and264 of thesuture222 is increased.
• As thesprings278 are compressed, a movable contact282 (FIG. 11) moves upward toward asecond contact284. Themovable contact282 is fixedly connected to thelower member276. Thesecond contact284 is fixedly connected to theupper member270. Themovable contact282 moves upward into engagement with the second orupper contact284 when thesprings278 have been compressed to a predetermined extent by movement of thelower member276 toward theupper member270. When thesprings278 have been compressed to the predetermined extent, a predetermined force is transmitted from thelower member276 to theupper member270. This predetermined force is transmitted to thesections262 and264 of the suture through thepin272 connected with theupper member270.
• When themovable contact282 engages thesecond contact284 and the predetermined tension force is present in thesuture222, a circuit is completed betweenconductors286 and288 connected with themovable contact282 andsecond contact284. Theconductors286 and288 are connected with thecontroller256. This enables thecontroller256 to detect when themovable contact282 engages the second orupper contact284 and when the predetermined tension is present in thesuture222. Thecontroller256 provides a visual and/or an audible signal to indicate to the surgeon that the predetermined tension force is being applied to thesections262 and264 of thesuture222.
• Theforce application assembly242 is operable to apply at least a predetermined force to theretainer244. This predetermined force urges the retainer toward thesoft body tissue224 andbone226. The force transmitted from theretainer244 to thesoft body tissue224 is effective to compress the soft body tissue against thebone226.
• Theforce application assembly242 includes a circularlower member294 which is located at the lower end of the housing234 (FIG. 10). Thelower member294 is movable upward from its lowermost position shown inFIG. 11. Thelower member294 is engageable with theretainer244. Thelower member294 may have a lower (as viewedFIG. 11) side surface which is shaped to provide a recess in which the upper portion of theretainer244 is received. Thus, although thelower member294 is illustrated inFIG. 11 as having a flat circular lower side surface, thelower member294 could have a concave surface with an arc of curvature which corresponds to the arc of curvature of thespherical retainer244.
• Anupper member298 in theforce application assembly242 has a generally cylindrical configuration and is disposed in a coaxial relationship with thelower member294. Theupper member298 is fixedly connected with the housing234 (FIG. 10). Thelower member294 is axially movable relative to thehousing234. Thelower member294 is connected with theupper member298 by a plurality of springs which have been illustrated schematically at302 inFIG. 11.
• Anupper contact304 is fixedly connected with theupper member298. A lower ormovable contact306 is connected with thelower member294. Theupper contact304 is connected with thecontroller256 by aconductor310. Themovable contact306 is connected with thecontroller256 by aconductor312.
• Aguide rod313 extends between thelower member294 in theforce application assembly242 and theupper member270 in thesuture tensioning assembly238. The guide rod interconnects thesuture tensioning assembly238 and theforce application assembly242. In addition, the guide rod guides relative movement between theupper member270 andlower member276 in thesuture tensioning assembly238 and relative movement between theupper member298 andlower member294 in theforce application assembly242. Although only asingle guide rod313 has been illustrated inFIG. 11, it should be understood that a plurality of guide rods are provided in theapparatus220.
• When a predetermined force is to be transmitted through theretainer244 to thebody tissue224 andbone226, a knurled handle portion314 (FIG. 10) of thehousing234 is manually grasped. Acollar315 may be provided adjacent to the lower end of thehandle portion315. Force is manually applied to thehousing234 urging the housing downward (as viewed inFIG. 11) toward theretainer244. At the same time, an upward force is being manually applied against thehandles282 and284.
• The downward force which is manually applied to thehousing234 is transmitted to the upper member298 (FIG. 11) which is fixedly connected with the housing. This downward force is transmitted from theupper member298 through thesprings302 to thelower member294. Thelower member294 transmits the force to theretainer244 which is pressed against thesoft body tissue224.
• As thehousing234 andupper member298 are manually urged downward toward theretainer244, the springs302 (FIG. 11) are compressed. As thesprings302 are compressed, theupper contact304 approaches thelower contact306. When thesprings302 have been compressed to a predetermined extent, a predetermined force is transmitted from theupper member298 through thesprings302 andlower member294 to theretainer244 andbody tissue224. As this occurs,upper contact304 engages thelower contact306.
• Engagement of thecontacts304 and306 completes a circuit which enables thecontroller256 to detect that at least a predetermined force has been transmitted from theforce application assembly242 to theretainer244 and thebody tissue224 andbone226.
• When thecontroller256 detects both the presence of the predetermined tension in thesuture222 and the application of the predetermined force against theretainer244, the controller initiates operation of theconnector assembly248 to connect the retainer with the suture. Theconnector assembly248 includes a pair ofmovable members316 and318 which are disposed adjacent to diametrically opposite sides of theretainer244. Anactuator320 is connected with themovable member316. Anactuator322 is connected with themovable member318. Theactuators320 and322 are connected with thecontroller256 byconductors324 and326.
• In the embodiment of the invention illustrated inFIG. 11, theactuators320 and322 are operable to press themovable members316 and318 against opposite sides of theretainer244 and to effect plastic deformation of the material of theretainer244. Force applied against opposite sides of theretainer244 by themembers316 and318 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 theretainer244 results in a collapsing of a passage in the retainer through which thesections262 and264 of the suture extend. As the passage through theretainer244 collapses and the material of the retainer cold flows, the material flows around thesections262 and264 of thesuture222. This enables the material of theretainer244 to bond to and obtain a firm grip on thesuture222.
• In the embodiment of the invention illustrated inFIG. 11, thesections262 and264 of thesuture222 extends straight through the passage in theretainer244. However, if desired, thesections262 and264 of thesuture222 could be wrapped around the retainer. If this was done, the force applied against the sections of the suture and theretainer244 would embed the suture turns around the outside of theretainer244 in the material of the retainer and enhance the grip between thesuture222 and theretainer244.
• During the time in which theforce application members316 and318 are applying clamping forces against opposite sides of theretainer244, the retainer is pressed against the upper side surface of thebody tissue224 with a predetermined force. In addition, a predetermined tension is maintained in thesections262 and264 of thesuture222.
• In the embodiment of the invention illustrated inFIG. 11, clamping forces have been applied against opposite sides of theretainer244 to cause cold flowing of the material of the retainer. However, if desired, theconnector assembly248 could be constructed so as to effect heating of the material of theretainer244 by the application of ultrasonic vibratory energy to the retainer. The frictional heat created by the ultrasonic vibratory energy transmitted to thesuture retainer244 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 thesections262 and264 of thesuture222. If theconnector assembly248 is to be constructed so as to apply ultrasonic vibratory energy to theretainer244, themovable member316 could be an anvil which engages one side of the retainer and themovable member318 could be a horn which applies ultrasonic vibratory energy to the retainer.
• Once theretainer244 has been securely connected with thesections262 and264 of thesuture222, thetrimmer assembly252 is operated to sever thesections262 and264 of the suture. Thetrimmer assembly252 is operable to sever thesections262 and264 of thesuture222 at a location disposed between thesuture tensioning assembly238 and theforce application assembly242. Since theretainer244 has been securely connected to the suture before thetrimmer assembly252 is operated, the retainer is effective to maintain the predetermined tension in thesections262 and264 of the suture which extend between the retainer and theanchor260. In addition, theretainer244 is effective to apply the predetermined force against thebody tissue224.
• Thetrimmer assembly252 includes a pair ofcutter assemblies340 and342. Thecutter assemblies340 and342 are connected with thecontroller256 byconductors344 and346. After completion of operation of theconnector assembly248 to connect theretainer244 with thesections262 and264 of thesuture222, thecontroller256 initiates operation of thecutter assemblies340 and342 in thetrimmer assembly252 to sever thesections262 and264 of thesuture222.
• When the suture222 (FIG. 11),anchor260 andretainer244 are to be utilized to secure thesoft body tissue224 with thebone226, thesuture222 is inserted through the passages in theanchor260 in the manner previously explained in conjunction with the embodiment of the invention illustrated inFIGS. 1-4. When this has been done, apointed end portion352 of theanchor260 is positioned relative to thesoft body tissue224 while the soft body tissue is in a desired location relative to thebone226 in the manner illustrated schematically inFIG. 3. An inserter assembly is then utilized to move theanchor20 through thebody tissue224 and into thebone226. When the anchor has been moved to a predetermined depth in thecancellous bone230, the anchor is toggled from an orientation similar to the orientation illustrated inFIG. 3 to the orientation illustrated inFIG. 11.
• Once theanchor260 andsuture222 have been positioned relative to thebody tissue224 andbone226, theretainer244 is slid along thesections262 and264 of the suture into engagement with thebody tissue224. Thesuture sections262 and264 are then positioned in the apparatus220 (FIG. 10). Aslot356 is formed in theapparatus220 to facilitate positioning of thesections262 and264 of the suture in the apparatus. Theslot256 extends through the housing to central portions of the suture tensioning assembly238 (FIG. 11),force application assembly242,connector assembly248, andtrimmer assembly252. Although it is believed that it will be preferred to utilize theslot356 to facilitate positioning of thesuture222 relative to theapparatus220, a passage could be provided through the apparatus and thesections262 and264 of the suture inserted through the passage.
• Once thesections262 and264 of thesuture222 have been positioned in theapparatus220, the apparatus is moved along thesuture222 into engagement with theretainer244. While theapparatus220 is pressed firmly against theretainer244, thesections262 and264 of the suture are tied to thepin272. At this time, there will be some tension in thesections262 and264 of thesuture222 and there will be some force transmitted from theforce application assembly242 to theretainer244. However, the tension in the suture and the force transmitted to the retainer will be less than a minimum desired tension and force.
• In order to effect the transmission of the desired force from theapparatus220 through theretainer244 to thesoft body tissue224 andbone226, a surgeon manually grasps the handle portion314 (FIG. 10) of thehousing234 with one hand and pushes the housing toward the retainer244 (FIG. 11). As this occurs, thesprings302 in the force application assembly are compressed and thecontact304 moves into engagement with thecontact306 to indicate to the controller that the predetermined force is being transmitted from theapparatus220 to theretainer244. At this time, thecontroller256 may provide a visual and/or audible indication to the surgeon that a predetermined force has been transmitted through theretainer244 to thebody tissue224.
• The surgeon then grasps thehandles282 and284 (FIG. 10) with the other hand and pulls the handles upward. As this occurs, thesprings278 in thesuture tensioning assembly238 are compressed and force is applied against theupper member270 to increase the tension in thesuture sections262 and264. When a predetermined tension is present in thesuture sections262 and264, thelower contact282 in thesuture tensioning assembly238 is in engagement with theupper contact284 to provide an indication to the controller that the predetermined tension is present in the suture. At this time, thecontroller256 may provide a second visual or audible signal to the surgeon.
• When the predetermined tension is present in thesections262 and264 of thesuture222 and the predetermined force is being transmitted from theretainer244 to thesoft body tissue224 andbone226, thecontroller256 effects operation of theconnector assembly248 to securely connect theretainer244 with thesections262 and264 of suture. After theretainer244 has been connected with thesections262 and264 of the suture, thecontroller256 effects operation of thetrimmer assembly252 to sever thesections262 and264 of the suture. This enables theapparatus220 to be moved away from thebody tissue224.
Embodiment of FIG. 12
• In the embodiment of the invention illustrated inFIG. 11, asuture retainer244 is connected with thesections262 and264 of thesuture222. In the embodiment of the invention illustrated inFIG. 12, the sections of the suture are connected to each other. Since the embodiment of the invention illustrated inFIG. 12 is similar to the embodiments of the invention illustrated inFIGS. 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 inFIGS. 1-11 may be used with the embodiment of the invention illustrated inFIG. 12.
• Theapparatus420 is utilized to secure asuture422 relative tosoft body tissue424 and abone426. Thesuture422 may have the same construction as thesuture36 ofFIGS. 3 and 4. Thespecific suture422 is a monofilament having a continuous cylindrical outer side surface. However, thesuture422 may be formed a plurality of intertwined strands or filaments.
• Thebone426 includes a compactouter layer428 which enclosescancellous bone430. Although thesuture422 has been illustrated schematically inFIG. 12 as being associated withsoft body tissue424 and abone426, it is contemplated that 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 thesuture422 could be associated with body tissue in any desired way.
• Theapparatus420 includes asuture tensioning assembly438 which is operable to tension thesuture422 with a predetermined tension force. Theapparatus420 also includes aforce application assembly442 which is operable to transmit a predetermined force to thesoft tissue424 andbone426. Theapparatus420 also includes aconnector assembly448.
• Theconnector assembly448 is operable to connectsections462 and464 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 thesoft tissue424 andbone426. Thus, theconnector assembly448 is operable to connect the twosections462 and464 of thesuture422 with each other while thesuture tensioning assembly438 tensions the suture to provide a tension force of at least a predetermined magnitude in thesections462 and464 of the suture. In addition, theconnector assembly448 is operable to connect thesections462 and464 of thesuture422 together while theforce application assembly442 is operable to transmit at least a predetermined force to thesoft tissue424 andbone426.
• Atrimmer assembly452 is operable to sever thesections462 and464 of thesuture422 while the predetermined tension force is present in the sections of the suture and while the predetermined force is transmitted to thesoft tissue424.
• Acontroller456 effects operation of theconnector assembly448 to connect thesuture sections462 and464 together in response to both detection that at least a predetermined tension force is present in thesections462 and462 of the suture and detection that at least a predetermined force is being transmitted to thesoft tissue424 andbone426. Thesuture tensioning assembly438,force application assembly442,connector assembly448, andtrimmer assembly452 are at least partially enclosed by a housing which corresponds to thehousing234 ofFIG. 10. Thecontroller456 is connected with the housing by a suitable cable, corresponding to thecable258 ofFIG. 10. However, the controller could be mounted in or on the housing for theapparatus420 if desired.
• It should be understood that thesuture tensioning assembly438 ofFIG. 12 corresponds to thesuture tensioning assembly238 ofFIG. 11. Similarly, theforce application assembly442 ofFIG. 12 corresponds to theforce application assembly242 ofFIG. 11. Theconnector assembly448 ofFIG. 12 corresponds to theconnector assembly248 ofFIG. 11. Thetrimmer assembly452 ofFIG. 12 corresponds to thetrimmer assembly252 ofFIG. 11.
• The suture tensioning assembly438 (FIG. 12) includes a circularupper member470 and a circularlower member472. In accordance with a feature of the embodiment of the invention illustrated inFIG. 12,force transducers478 interconnect the upper andlower members472. Theforce transducers478 are connected with thecontroller456 byleads486 and488.
• Although theforce transducers478 could have many different constructions, it is contemplated that they may be piezoelectric transducers having a piezoelectric crystal as a sensitive element. The piezoelectric crystals in theforce transducers478 have outputs which correspond to the magnitude of the force being transmitted from thelower member422 through theforce transducers478 to theupper member470.
• Thesections462 and464 of thesuture422 are secured to apin472 extending upward from theupper member470. Therefore, force transmitted from thelower member472 to theupper member470 is transmitted from the upper member through thepin472 to thesuture sections462 and464. The output from theforce transducers478 indicates to thecontroller456 when a predetermined tension force has been transmitted from thelower member472 through theforce transducers478 andupper member470 to thesections462 and464 of thesuture422.
• A pair of handles (not shown), corresponding to thehandles282 and284 ofFIG. 10, are connected with thelower member472. The handles connected with thelower member472 are manually engageable. Force which is manually applied to the handles is transmitted from thelower member472 through theforce transducers478 to theupper member470.
• Theforce application assembly442 is operable to transmit a predetermined force to thesoft tissue424 andbone426. Theforce application assembly442 includes a cylindricallower member494 which extends downward into engagement with aforce distribution member496 which is disposed on thesoft tissue424. The force distribution member orbutton496 has a generally circular configuration with a pair of passages through which thesections462 and464 of thesuture422 extend. If desired, theforce distribution member496 could be eliminated.
• Theforce application assembly494 also includes a cylindricalupper member498. Theupper member498 is connected with the housing (not shown) which encloses theapparatus420 and corresponds to thehousing234 ofFIG. 10.
• Theupper member498 is connected with thelower member494 by a plurality offorce transducers502. Theforce transducers502 are connected with thecontroller456 throughconductors510 and512. The output from theforce transducers502 corresponds to the magnitude of the force transmitted from theupper member498 to thelower member494.
• Although theforce transducers502 may have many different constructions, in one specific embodiment of the invention, theforce transducers502 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 an output to the controller which would indicate when at least a predetermined force is being transmitted from theupper member498 to thelower member494 and thesoft tissue424 andbone426.
• Theconnector assembly448 includesmovable members516 and518. Themovable members516 and518 are connected withactuators520 and522. Theactuators520 and522 are connected with thecontroller456 byconductors524 and526.
• Themovable member516 andmovable member518 extend through slots formed in thelower member494. Thus, thelower member494 has a cylindrical configuration and includes radially extending slots in which themovable members516 and518 are received. The lower (as viewed inFIG. 12) end portion of thelower member494 is disposed in abutting engagement with theforce distribution member496 and is effective to transmit force to the force distribution member. Although themovable members516 and518 have been illustrated schematically inFIG. 12 as being spaced from theforce distribution member496, it should be understood that the movable members engage and slide along the force distribution member.
• When thecontroller456 receives an output from thetransducers478 indicating that at least a predetermined tension is present in thesections462 and464 of thesuture422 and receives an output from theforce transducers502 indicating that at least a predetermined force is being transmitted to thesoft tissue424 andbone426, thecontroller456 effects operation of theconnector assembly448 to interconnect thesections462 and464 of thesuture422. Thus, thecontroller456 effects operation of theactuators520 and522 to press themembers516 and518 against opposite sides of thesections462 and464 of thesuture422. While a predetermined clamping force is being applied against thesuture sections462 and464 to press them against each other, thecontroller456 effects operation of theconnector assembly448 to connect thesections462 and464 of thesuture422 to each other.
• In the embodiment of the invention illustrated inFIG. 12, thesections462 and464 of thesuture422 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, themovable member516 functions as an anvil and themovable member518 functions as a horn.
• The movable member or horn is518 vibrated at a rate in excess of 20 kilohertz. Although thehorn518 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 ormovable member518 at a rate which is close to or greater than 70 kilohertz. Thehorn518 is vibrated for a dwell time which is sufficient to transmit enough ultrasonic vibratory energy to thesections462 and464 of the suture to heat a portion of the material of the sections of the suture into a transition temperature range of the material.
• To effect a heating of the material of thesuture sections462 and464, mechanical vibrations are transmitted from the horn ormovable member518 to an interface where thesuture sections462 and464 are pressed against each other by theanvil516 andhorn518. As the material of thesuture sections462 and464 are heated into a transition temperature range, the material loses its rigidity and softens. However, the material of thesections462 and464 of thesuture422 do not melt and lose substantial tensile strength as the material is heated.
• The heated and softened material of thesections462 and464 of thesuture422 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 thesections462 and464 of the suture are pressed together and flattened, they expand in opposite directions transverse to the central axes of the suture sections.
• After the suture sections have been interconnected by theconnector assembly448, atrimmer assembly452 is operated to sever thesuture sections462 and464 at a location between thesuture tensioning assembly438 and forceapplication assembly442. Thetrimmer assembly452 includescutter assemblies540 and542 which are connected with thecontroller456 byconductors544 and546. A predetermined time period after theconnector assembly448 has interconnected thesuture sections462 and464, thecontroller456 effects operation of actuators in thecutter assemblies540 and542 to sever the suture sections.
CONCLUSION
• In view of the foregoing description, it is apparent that the present invention relates to a method and apparatus for use in securingsoft tissue40,hard tissue44, and/or hard and soft tissue in a patient's body. The hard tissue may be any one of the many bones in a patient's body. The soft tissue may be any one of the tissues in a patient's body other than the hard tissue.
• The tissue may be secured by using asuture36. The suture may be connected with ananchor20. When theanchor20 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. Theanchor20 may be formed of two or more different materials.
• When asuture36 is utilized to securebody tissue40 and44, aretainer82 may be connected with the suture. Alternatively,sections112 and114 of thesuture110 may be connected with each other.
• If asuture110 is utilized to secure the body tissue, anapparatus120,220 or420 may advantageously be provided to tension the suture with a predetermined force. If aretainer244 is utilized in association with the suture, theapparatus220 may urge the retainer toward the body tissue with a predetermined force. Theretainer244 may be connected with thesuture222 in response to detection of at least a predetermined tension in the suture and/or the transmission of a predetermined force to thebody tissue224. When theretainer244 is to be eliminated, thesections462,464 of thesuture422 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.
• Theanchor22, for some uses at least, may be formed of a single piece of bone. Apointed end portion24 of the anchor may have a surface which forms an opening in a bone or other tissue in a patient's body. Theanchor22 may be moved into the opening formed in the tissue by the pointed leading end portion of the anchor.
• 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, aretainer82 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.
• All references cited herein are expressly incorporated by reference in their entirety.
• 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.

Claims (43)

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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 1, wherein the cancellous matter serves as a fulcrum, and leverage is created by positioning the aperture near the leading end.

10. The method ofclaim 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 ofclaim 1, wherein the sutures are polymeric.

12. The method ofclaim 1, wherein the body tissue to be connected is a ligament or tendon.

13. The method ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 15, wherein said at least one sensor measures tension in each of two suture sections.

20. The device ofclaim 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 ofclaim 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 ofclaim 15, wherein said second suture engaging surface is further operative to transmit ultrasonic vibratory energy.

23. The device ofclaim 15, wherein the suture sections are formed from a material selected from the group consisting of: polymer, amorphous polymer.

24. The device ofclaim 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 ofclaim 15, wherein said at least one body tissue engaging surface applies a predetermined pressure to the body tissue.

26. The device ofclaim 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 ofclaim 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 ofclaim 28, wherein said tension and pressure resilient members are springs.

30. The device ofclaim 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 ofclaim 30, wherein said tension and pressure force transducers are piezoelectric force transducers.

32. The device ofclaim 27, further including:

a cutter connected to said frame, operative to cut at least two suture sections.

33. The device ofclaim 27, wherein said suture holder is selected from the group consisting of: a pin, a clamp.

34. The device ofclaim 27, wherein said ultrasonic vibratory energy is between 20 and about 70 kilohertz.

35. The device ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 40, wherein the therapeutic object is an arthroplasty component.

42. The method ofclaim 40, wherein the therapeutic object surface is metal.

43. The method ofclaim 40, wherein the therapeutic object is a joint implant component.

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