US20080114399A1 - Method of securing body tissue - Google Patents

Abstract

To secure a first body tissue with a second body tissue, a first anchor is moved along a first path through the first body tissue into the second body tissue. A second anchor is moved along a second path through the first body tissue into the second body tissue. A suture extending between the anchors may be tightened by moving the second anchor along a path which extends transverse to the path of the first anchor. The suture which extends between the anchors may have free ends which are connected with a suture retainer. The free ends of the suture may be interconnected either before or after the anchors are moved along the first and second paths. Alternatively, the suture may be a continuous loop which extends between the two anchors. A guide assembly may be provided to guide movement of the anchors along the two paths. The paths along which the anchors move may intersect so that the anchors may be interconnected at the intersection between the two paths.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 11/460,650, filed Jul. 28, 2006. The aforementioned application Ser. No. 11/460,650 is a continuation of U.S. patent application Ser. No. 10/413,696, filed Apr. 14, 2003 (now U.S. Pat. No. 7,087,073). The aforementioned application Ser. No. 10/413,696 is a divisional of U.S. patent application Ser. No. 09/789,621, filed Feb. 21, 2001 (now U.S. Pat. No. 6,635,073). The aforementioned application Ser. No. 09/789,621 is a continuation-in-part of U.S. patent application Ser. No. 09/556,458, filed May 3, 2000 (now U.S. Pat. No. 6,592,609). The benefit of the earlier filing dates of the aforementioned applications is hereby claimed for all subject matter common to this application and the aforementioned applications.
BACKGROUND OF THE INVENTION
• The present invention relates to a method of securing tissue in a body of a patient. The method may be utilized to secure soft body tissues, hard body tissues, or to secure both soft and hard body tissues.
• Many different devices have previously been utilized to secure body tissues. Many of these devices have utilized anchors which engage either soft body tissue or hard body tissue to hold a suture in a desired location relative to the body tissue. Various methods and devices for use in positioning anchors relative to either soft or hard body tissues are disclosed in U.S. Pat. Nos. 5,403,348; 5,464,426; 5,534,012; 5,593,425; 5,718,717; and 5,948,002. The devices and methods disclosed in these patents have been generally satisfactory in securing either soft, hard, or hard and soft body tissues. Other devices and methods for securing body tissues are disclosed in U.S. Pat. Nos. 4,235,238; 4,448,194; 4,669,473; 5,085,661; and 5,372,146.
SUMMARY OF THE INVENTION
• The present invention relates to a new and improved method of securing a first body tissue with a second body tissue. The first body tissue may be a soft body tissue and the second body may be a hard body tissue. Alternatively, the first and second body tissues may both be soft body tissues. It is also contemplated that both the first and second body tissues could be hard body tissues.
• When the first and second body tissues are to be interconnected, a first anchor is moved into the second body tissue. If desired, the first anchor could be moved into and through the second body tissue. A second anchor is also moved into the second body tissue. If desired, the second anchor could be moved into and through the second body tissue. The first body tissue may be pressed against or otherwise secured with the second body tissue under the influence of force transmitted from the suture to the first body tissue.
• The suture which extends between the anchors may be tensioned by moving at least one of the anchors into the body tissue along a path which extends transverse to a path along which the other anchor is moved into the body tissue. The paths along which the anchors move into the body tissue may extend toward each other. The transverse paths of movement of the anchors into the body tissue promotes gripping of body tissue with the anchors and suture and promotes tensioning of the suture as the anchors move into the body tissue. Although it is believed that it may be desired to move the anchors into the body tissue along transverse paths, it is contemplated that the anchors could be moved into the body tissue along parallel paths if desired.
• A desired tension may be established in the suture by moving the anchors into the body tissue. Alternatively, a desired tension may be established in the suture by applying force to portions of the suture and then interconnecting the portions of the suture. A retainer or a knot may be utilized to interconnect portions of the suture.
• Regardless of how the tension is established in the suture, it may be desired to establish a predetermined tension in the suture. This may be done by determining the tension in the suture as the anchors are moved into the body tissue. Alternatively, the tension in the suture may be determined during movement of a retainer relative to portions of the suture prior to gripping of the suture with the retainer.
• The suture may be a continuous loop which extends between the two anchors. The tension in the loop may be determined as one or more of the anchors are moved into the body tissue. Alternatively, the suture may be formed by a pair of separate portions which are tensioned after the anchors are moved into the body tissue.
• One or more guides may be utilized to facilitate positioning of the anchors for movement along paths disposed in a desired spatial relationship with the body tissue. The guides may have tubular guide surfaces with central axes which extend transverse to each other.
• Leading end portions of the anchors may be utilized to initiate the formation of openings in the first and/or second body tissue. The leading end portion of each of the anchors may be utilized to pierce soft body tissue, a hard outer layers of bone, and/or cancellous bone as the anchor is moved into the body tissue. If either or both of the anchors are associated with body tissue which is bone, one or more of the anchors may be supported in a spaced apart relationship with a hard outer layer of bone by cancellous bone which is enclosed by the hard outer layer of bone. If desired, passages for the anchors may be formed with a drill or similar tool.
• The anchors may advantageously be interconnected while they are disposed in the body tissue. When this is done, the anchors may be moved along transverse paths which intersect in the body tissue. The anchors may be interconnected at the intersection between the two paths.
• There are a plurality of embodiments of the invention. Each embodiment of the invention has one or more features which may be advantageously utilized with one or more of the other embodiments of the invention. It is contemplated that the various features of the embodiments of the invention may be utilized separately or combined in any one of many different combinations.
BRIEF DESCRIPTION OF THE DRAWINGS
• The foregoing and other features of the invention will become more apparent upon a consideration of the following description taken in connection with the accompanying drawings wherein:
• FIG. 1 is a fragmentary schematic illustration depicting the relationship between a plurality of anchors and body tissue prior to movement of the anchors into the body tissue;
• FIG. 2 is a fragmentary schematic illustration depicting the manner in which one of the anchors ofFIG. 1 is positioned relative to body tissue prior to initiation of formation of an opening in body tissue with a leading end portion of the anchor;
• FIG. 3 is a fragmentary schematic view illustrating the manner in which the anchor ofFIG. 2 is moved through first body tissue into second body tissue;
• FIG. 4 is a fragmentary schematic illustration illustrating the manner in which the anchor ofFIG. 3 is moved deeper into the second body tissue;
• FIG. 5 is a fragmentary schematic illustration depicting the manner in which the orientation of the anchor ofFIG. 4 is changed relative to the body tissue after the anchor has been moved to a desired depth in the body tissue;
• FIG. 6 is a schematic fragmentary illustration, generally similar toFIG. 3, illustrating the manner in which a second one of the anchors ofFIG. 1 is moved through first body tissue into second body tissue;
• FIG. 7 is a fragmentary schematic illustration, generally similar toFIG. 4, depicting the manner in which the anchor ofFIG. 6 is moved deeper into the body tissue;
• FIG. 8 is fragmentary schematic illustration, generally similar toFIG. 5, depicting the manner in which the orientation of the anchor ofFIG. 7 is changed after the anchor has been moved to a desired depth in the body tissue;
• FIG. 9 is a fragmentary schematic illustration depicting the relationship between the anchors ofFIG. 1 and a suture extending between the anchors after the anchors have been moved into the body tissue;
• FIG. 10 is schematic illustration, generally similar toFIG. 9, depicting the manner in which the suture extending between the anchors is tensioned with a predetermined force and in which a retainer is deformed to grip portions of the suture;
• FIG. 11 is a fragmentary schematic illustration, generally similar toFIGS. 1 and 9, depicting the manner in which a pair of anchors interconnected by a continuous loop of suture are positioned relative to body tissue and the loop is tensioned during positioning of the anchors relative to the body tissue;
• FIG. 12 is a fragmentary schematic illustration, generally similar toFIG. 6, illustrating the relationship between an anchor ofFIG. 11 and an apparatus which is utilized to effect movement of the anchor into body tissue and to measure tension in the continuous loop of suture extending between the anchors ofFIG. 11;
• FIG. 13 is a schematic illustration, generally similar toFIG. 11, illustrating the manner in which a guide assembly is utilized to position anchors relative to body tissue;
• FIG. 14 is a schematic illustration depicting the manner in which a thin elongated member is utilized to guide movement of an anchor into body tissue;
• FIG. 15 is a fragmentary schematic illustration depicting the manner in which a second thin elongated member is utilized to guide movement of a second one of the anchors ofFIG. 14 into the body tissue;
• FIG. 16 is a fragmentary schematic illustration, similar toFIG. 13, of another embodiment of a guide assembly which is utilized to position anchors relative to body tissue and depicting the manner in which tubular guide members extend through first body tissue into second body tissue;
• FIG. 17 is a fragmentary schematic illustration depicting the manner in which anchors are utilized to repair a fracture in a bone;
• FIG. 18 is a schematic illustration of another embodiment of the anchor;
• FIG. 19 is an illustration of still another embodiment of the anchor;
• FIG. 20 is a fragmentary schematic illustration, generally similar toFIG. 9, illustrating the manner in which anchors are interconnected at an intersection between transverse paths along which the anchors are moved into body tissue;
• FIG. 21 is an enlarged fragmentary view of a portion ofFIG. 20 and illustrating how the anchors are interconnected at the intersection of the paths along which the anchors are moved into in the body tissue;
• FIG. 22 is a fragmentary schematic illustration, generally similar toFIG. 21, illustrating the manner in which another embodiment of the anchors are interconnected at the intersection between the paths along which the anchors are moved into the body tissue; and
• FIG. 23 is a fragmentary sectional view, generally similar toFIG. 12, illustrating the manner in which another embodiment of the anchors may be utilized to secure body tissues.
DESCRIPTION OF SPECIFIC PREFERRED EMBODIMENTS OF THE INVENTIONGeneral Description
• An apparatus10 (FIG. 1) is used to secure firsthuman body tissue12 with secondhuman body tissue14. In the illustration ofFIG. 1, thefirst body tissue12 is soft body tissue and thesecond body tissue14 is hard body tissue. However, it should be understood that both thefirst body tissue12 and thesecond body tissue14 could be soft body tissue if desired. Alternatively, both thefirst body tissue12 and thesecond body tissue14 could be hard body tissue.
• Theapparatus10 includes a plurality of suture anchors18 and20. Although only two suture anchors18 and20 have been illustrated inFIG. 1, it should be understood that a greater number of suture anchors could be provided if desired. For example, it is contemplated that three anchors could be provided if desired.
• Theapparatus10 also includes asuture24 which extends between the suture anchors18 and20. Although the illustratedsuture24 is integrally formed as one piece and extends between theanchors18 and20, it is contemplated that thesuture24 could be formed by a plurality of separate portions each of which is connected with one of the anchors. Thus, a first segment of a suture could be connected with theleft suture anchor18 and a second segment of a suture could be connected with theright suture anchor20.
• When the first andsecond body tissues12 and14 are to be interconnected, the suture anchors18 and20 are moved through thefirst body tissue12 into thesecond body tissue14. If desired, the suture anchors18 and20 could be moved into and through thesecond body tissue14.
• When theanchor18 is to be moved into thebody tissue12, the anchor may be positioned in aninserter28 and pressed against thebody tissue12 by a pusher member30 (FIG. 2). A trailingend portion32 of theanchor18 is positioned in theinserter28 and is engaged by thepusher member30. A pointed leadingend portion34 of theanchor18 extends from theinserter28.
• In the embodiment illustrated inFIG. 2, theinserter28 has a tubular configuration and thepusher member30 is telescopically inserted into the inserter. However, if desired, theinserter28 could have a different configuration and could be constructed in such a manner as to perform the function of thepusher member30. For example, theinserter28 could be constructed could be a solid rod with a gripper at one end of the rod. This inserter would grip and apply axial force against a trailingend portion32 of theanchor18.
• When theanchor18 is to be moved into thebody tissue12, theleading end portion34 of theanchor18 initiates the formation of an opening in thebody tissue12. Force applied against the trailingend portion32 of theanchor18 by thepusher member30 causes the anchor to pierce thebody tissue12. As theanchor18 moves through thebody tissue12, theleading end portion34 of the anchor moves into engagement with thebody tissue14.
• Theleading end portion34 of theanchor18 initiates the formation of an opening in thebody tissue14. Force applied against the trailingend portion32 of theanchor18 by thepusher member30 moves the leading end portion of the anchor into the body tissue14 (FIG. 3). Continued axial movement of thepusher member30 relative to theinserter28 moves theanchor18 deeper into the body tissue14 (FIG. 4). As theanchor18 moves into thebody tissue14, theleading end portion34 of the anchor pierces the body tissue. Theanchor18 may be moved along a linear or nonlinear path in thebody tissues12 and14.
• In the embodiment of the invention illustrated inFIGS. 1-10, theanchor18 is utilized to form its own passage in thebody tissues12 and14. However, a drill or other tool could be utilized to form a passage for theanchor18 in either thebody tissue12 or14 or in both of the body tissues.
• Once theanchor18 has moved into thebody tissue14, the anchor may be toggled from the orientation shown inFIG. 4 to the orientation shown inFIG. 5 relative to thebody tissue14. Changing the orientation of theanchor18 relative to thebody tissue14 increases the ability of the anchor to withstand pull out force applied against the anchor by thesuture24.
• The anchor20 (FIG. 1) is inserted into the body tissue in the same manner as previously described in conjunction with theanchor18. Thus, theanchor20 is positioned in an inserter38 (FIG. 6) and is engaged by apusher member40. Thepusher member40 engages a trailingend portion42 of theanchor20.
• Thepusher member40 presses a pointed leadingend portion44 of theanchor20 against thebody tissue12 to initiate the formation of an opening in the body tissue. Theanchor20 then moves through thebody tissue12 and moves into engagement with thebody tissue14. The continued application of force against the trailingend portion42 of theanchor20 by thepusher member40 causes theleading end portion44 of the anchor to initiate the formation of an opening in thebody tissue14.
• As theanchor20 moves deeper into thebody tissue14, the anchor pierces the body tissue in the manner illustrated inFIG. 7. Theanchor20 may be moved along a linear or nonlinear path in thebody tissue14.
• Once theanchor20 has moved into thebody tissue14, the orientation of the anchor relative to the body tissue is changed with a toggling action. Thus, the orientation of theanchor20 is changed from the orientation illustrated inFIG. 7 to the orientation illustrated inFIG. 8. Changing the orientation of theanchor20 relative to the body tissue increases the ability of the anchor to withstand pull out forces transmitted through thesuture24.
• Once bothanchors18 and20 have moved through thebody tissue12 into thebody tissue14, thepusher members30 and40 (FIGS. 4,5,7, and8) are withdrawn from the body tissue. It is contemplated that theanchors18 and20 may be either sequentially moved into thebody tissue12 and14 or simultaneously moved into thebody tissue12 and14. If theanchors18 and20 are sequentially moved into thebody tissue12 and14, the same inserter and pusher member may be utilized to move both of the anchors into the body tissue. If theanchors18 and20 are simultaneously moved into thebody tissue12 and14,separate inserters28 and38 andpusher members30 and40 may be used to move the anchors into the body tissue. If desired, theinserters28 and38 andpusher members30 and40 may be interconnected and form portions of an inserter assembly.
• Although it is believed that it will be desired to pivot theanchors18 and20 from the orientations illustrated inFIGS. 4 and 7 to the orientations shown inFIGS. 5 and 8, theanchors18 and20 may be left in the orientations shown inFIGS. 4 and 7 if desired. It is believed that pivoting theanchors18 and20 to the orientations shown inFIGS. 5 and 8 will enable the anchors to remain stationary relative to thebody tissue14 when relatively large tension forces are transmitted to the anchors through thesuture24.
• The suture24 (FIG. 9) is integrally formed as one piece and includes aconnector portion48 which extends between the twoanchors18 and20. In addition, thesuture24 includes aleg portion50 which extends from theanchor18. Thesuture24 also includes aleg portion52 which extends from theanchor20. A suture retainer (crimp)54 is utilized to interconnect theleg portions50 and52 of thesuture24. Alternatively, theleg portions50 and52 may be tied together in a knot to interconnect the leg portions. If desired, theleg portions50 and52 could be bonded together by the application of ultrasonic vibratory energy directly to the leg portions.
• When theleg portions50 and52 of thesuture24 are to be interconnected with theretainer54, thesuture24 may be tensioned with a force application assembly60 (FIG. 10). Theforce application assembly60 applies a predetermined force, indicated schematically by anarrow62 inFIG. 10, to theleg portions50 and52 of thesuture24. Thepredetermined force62 has a magnitude which is a function of the size and strength of thesuture24.
• Thesuture retainer54 is pressed against thebody tissue12 by aforce application member66. Forces, indicated schematically at70 and72 inFIG. 10, are transmitted through theforce application member66 to thesuture retainer54 to press the suture retainer against thebody tissue12. The magnitude of the forces indicated by thearrows70 and72 and applied to thesuture retainer54 by theforce application member66, are a function of the size and strength of thesuture24.
• While thesuture24 is being tensioned under the influence offorce62 and while thesuture retainer54 is being pressed against thebody tissue12 under the influence offorces70 and72, thesuture retainer54 is plastically deformed to firmly grip thesuture24. To plastically deform thesuture retainer54, a pair offorce application members76 and78 are pressed against opposite sides of thesuture retainer54. The force with which theforce application members76 and78 are pressed against thesuture retainer54 is indicated schematically byarrows80 and82 inFIG. 10. The force applied against thesuture retainer54 by theforce application members76 and78 plastically deforms the material of the suture retainer while the suture retainer is being pressed against thebody tissue12 by theforce application member66 and while the suture is being tensioned by theforce application assembly60.
• In the embodiment of the invention illustrated inFIGS. 1-10, theanchors18 and20 are embedded in the body tissue14 (FIG. 10). However, theanchors18 and20 could be moved through thebody tissue14 if desired. This would result in theanchors18 and20 engaging an outer surface of thebody tissue14.
• When thebody tissue12 and14 are both soft body tissues, it is contemplated that the body tissues could be placed in apposition. Once thesoft body tissues12 and14 have been approximated, theanchors18 and20 would be moved through thebody tissue12 into thebody tissue14. If desired, theanchors18 and20 could be moved through thebody tissue14.
• In the embodiment of the invention illustrated inFIGS. 1-10, thebody tissue12 is secured with thebody tissue14 by thesuture24. In this embodiment, thesuture24 extends through thebody tissue12 and presses thebody tissue12 against thebody tissue14. However, thebody tissue12 could be secured with thebody tissue14 in a different manner. For example, thesuture24 could extend around thebody tissue12 without extending through thebody tissue12. Thebody tissue12 could be spaced from thebody tissue14 and secured with thebody tissue14 by a portion of the suture extending between thebody tissue12 and thebody tissue14.
• In the embodiment of the invention illustrated inFIGS. 1-10, thesuture24 hasleg portions50 and52 which extend from the suture anchors18 and20 and aconnector portion48 which extends between the suture anchors. In the embodiment of the invention illustrated inFIG. 11, the suture is formed as a continuous loop which extends between the two anchors. Since the embodiment of the invention illustrated inFIG. 11 is generally similar to the embodiment of the invention illustrated inFIGS. 1-10, similar numerals will be utilized to designate similar components, the suffix letter “a” being associated with the numerals ofFIG. 11 to avoid confusion.
• Anapparatus10a(FIG. 11) for use in securing first body tissue12awith second body tissue14aincludes a plurality of suture anchors18aand20a. Asuture24aextends between the anchors18aand20a. Although thesuture24ahas been illustrated inFIG. 11 as extending between only two anchors18aand20a, a greater number of anchors could be provided if desired.
• Thesuture24ais forms a continuous flexible loop. Thus, thesuture24aincludes a first connector portion48awhich extends between the suture anchors18aand20aand asecond connector portion90 which extends between the suture anchors. Theconnector portions48aand90 are interconnected by bonding their ends together under the influence of ultrasonic vibratory energy. However, theconnector portions48aand90 could be integrally formed as one piece. Theconnector portions48aand90 do not have free ends. Theconnector portions48aand90 may be interconnected by a device, such as theretainer54 ofFIG. 9, or a knot.
• Since thesuture24ais a continuous closed loop without free ends, thesuture24ais tensioned whenever the anchors18aand20aare moved into the body tissue14a. The anchor18ais moved through the body tissue12ainto the body tissue14ain the same manner as previously described in conjunction with the embodiment of the invention illustrated inFIGS. 1-10. The anchor20ais then moved through the body tissue12ainto the body tissue14a.
• As the anchor20amoves into the body tissue14a, the anchor20amoves from the position illustrated in solid lines inFIG. 11 to the position illustrated in dashed lines inFIG. 11. As the anchor20amoves into the body tissue14a, theconnector portions48aand90 of thesuture24aare both tensioned. The magnitude of the tension force in the continuous loop which is formed by thesuture24awill be a function of magnitude of the force which is utilized to move the suture anchors18aand20ainto the body tissue14a.
• The anchors18aand20amay be moved either sequentially or simultaneously into the body tissue14a. Thus, the anchor18amay be moved through the body tissue12ainto the body tissue14ain the manner illustrated in solid lines inFIG. 11. The anchor20amay then be moved through the tissue12ainto the tissue14ato the position illustrated in dashed lines inFIG. 11. Alternatively, the anchors18aand20amay both be simultaneously moved through the body tissue12aand into the body tissue14a. The anchors18aand20amay be moved along either linear or nonlinear paths in the body tissues12aand14a.
• It is contemplated that an inserter, corresponding to theinserter18 ofFIGS. 2-5, and a pusher member, corresponding to thepusher member30 ofFIGS. 2-5, will be utilized to position the anchor18ain the body tissue14a(FIG. 11). Similarly, an inserter, corresponding to theinserter38 ofFIGS. 6-8, and a pusher member, corresponding to thepusher member40 ofFIGS. 6-8, will be utilized to position the anchor20ain the body tissue14a(FIG. 11).
• In the embodiment of the invention illustrated inFIG. 11, only two anchors18aand20aare connected with the continuous loop formed by thesuture24a. However, a greater number of anchors, for example three, could be connected with the loop formed by thesuture24a. Upon insertion of the last anchor of the plurality of anchors, the loop formed by thesuture24awould probably slide in passages in at least one of the other anchors and the suture would be tensioned.
• In the embodiment of the invention illustrated inFIG. 12, an apparatus is provided to measure tension in a suture which forms a continuous closed loop. Since the embodiment of the invention illustrated inFIG. 12 is generally similar to the embodiment of the invention illustrated inFIGS. 1-11, similar numerals will be utilized to designate similar components, the suffix letter “b” being associated with the numerals ofFIG. 12 to avoid confusion.
• Ananchor20bis positioned in an inserter28band moved into body tissue under the influence of force applied against a trailing end portion42bof theanchor20bby apusher member40b. A tension measuring assembly96 is provided in association with theinserter38b. The tension measuring assembly96 includes aforce transmitting member100 having anend portion102 which engagesconnector portions48band90bof asuture24b. Although only asingle anchor20bis illustrated inFIG. 12, it should be understood that thesuture24bforms a continuous loop connected with a second anchor, corresponding to the anchor18aofFIG. 11.
• As theanchor20bmoves into the body tissue14b, thesuture24bapplies force against theend portion102 of theforce transmitting member100. Aforce measuring device112 is connected with theforce transmitting member100. Theforce measuring device112 measures the tension force in the continuous closed loop formed by thesuture24b. Theforce measuring device112 may be a load cell or other transducer.
• During movement of theanchor20binto the body tissue14b, theinserter38bis pressed against the body tissue14bby a remote inserter drive assembly110 (FIG. 12). While theinserter38bis held stationary and pressed against the body tissue14b, a pushermember drive assembly114 moves thepusher member40bandanchor20binto the body tissue14bin the manner previously described in conjunction with the embodiment of the invention illustrated inFIGS. 1-10. Theanchor20bmay be moved along either a linear path or a nonlinear path into the body tissue14b.
• The force measuring assembly96 is illustrated inFIG. 12 in association with asuture24bwhich is formed as a continuous loop. However, the force measuring assembly96 could be utilized with a suture having free end portions. Thus, the force measuring assembly96 could be used with thesuture24 ofFIGS. 1-10 if desired. If this was done, theconnector portion48 of thesuture24 would engage theend portion102 of theforce transmitting member100. If desired, theleg portion52 of thesuture24 could also engage theend portion102 of theforce transmitting member100.
• If desired, theforce measuring device112, pushermember drive assembly114, andinserter drive assembly110 may be formed as part of a robotic tool which is associated with a console that gives a three dimensional view of an operating table in an operating room of a hospital. Controls at the console provide tactile feedback to a surgeon operating the controls. The controls effect operation of thedrive assemblies110 and114 to move theanchor20binto the body tissue14b.
• The robotic tool may include apparatus to move an anchor corresponding to theanchors18 or18aofFIGS. 1 and 11 into thebody tissue12band14b. Thus, the robotic tool also includes a second inserter drive assembly, having the same construction as theinserter drive assembly110 ofFIG. 12, to position an inserter, corresponding to theinserter28 ofFIG. 2, relative to thebody tissue12band14b. The robotic tool also includes a second pusher member drive assembly, having the same construction as the pushermember drive assembly114 ofFIG. 12, to position a pusher member, corresponding to thepusher member40 ofFIG. 2, relative to thebody tissue12band14b.
• The robotic tool may be operated to effect simultaneous movement of two anchors, that is, an anchor corresponding to the anchor18 (FIG. 1) and an anchor corresponding to theanchor20b(FIG. 12), into thebody tissues12band14b. As theanchors18 and20bmoves into the body tissue14b, the continuous loop formed by thesuture24bis tensioned. Theforce transmitting member100 transmits a force which is a function of the tension in thesuture24bto theforce measuring device112. When theforce measuring device112 detects that the desired tension is present in thesuture24b, operation of the pusher member drive assemblies is interrupted with theanchors18 and20bin a desired position relative to the body tissue14b.
• In the embodiment of the invention illustrated inFIG. 13, a guide assembly is utilized to position a suture anchor relative to the body tissue. Since the embodiment of the invention illustrated inFIG. 13 is generally similar to the embodiments of the invention illustrated inFIGS. 1-12, similar numerals will be utilized to designate similar components, the suffix letter “c” being associated with the numerals ofFIG. 13 to avoid confusion.
• Aguide assembly120 is utilized in association with anapparatus10c. Theapparatus10cincludes a plurality of suture anchors18cand20c. Although only twoanchors18cand20chave been illustrated, a greater number of anchors could be utilized if desired.
• Asuture24cextends from the suture anchors18cand20c. In the embodiment of the invention illustrated inFIG. 13, thesuture24cis a continuous loop, in the same manner as thesuture24aofFIG. 11. However, thesuture24ccould have free ends and leg portions corresponding to theleg portions50 and52 of thesuture24 ofFIG. 1.
• Theguide assembly120 includes a base124 which positions guides126 and128 relative tobody tissue12cand14c. Theguides126 and128 have a tubular configuration. Although only twoguides126 and128 have been provided for only twoanchors18cand20c, a greater number of guides could be provided for a greater number of anchors.
• Theanchors18cand20care positioned in theguides126 and128 in the same manner as in which they are positioned in theinserters28 and38 of the embodiment of the invention illustrated inFIGS. 2-8. Apusher member132 is utilized to apply force against theanchors18cand20cto move the anchors relative to theguides126 and128 and into thebody tissue12cand14c.
• Theguide128 is movable along the base124 to enable the distance between locations where theanchors18cand20cmove into thebody tissue12cand14cto be adjusted. The manner in which theguide128 is moved along thebase124 is indicated schematically byarrows136 inFIG. 13. Asuitable retainer140 is provided to connect theguide128 with the base124 in a desired position relative to theguide126.
• If theanchors18cand20care to be moved along nonlinear paths in the body tissue14c, theguides126 and128 could have a nonlinear configuration. For example, theguides126 and128 could be formed with an arcuate configuration. If this was done, thepusher member132 would be formed with an arcuate configuration corresponding to the arcuate configuration of theguides126 and128.
• In the embodiments of the invention illustrated inFIGS. 1-13, the anchors have pointed leading end portions which initiate the formation of openings in the body tissue. In the embodiment of the invention illustrated inFIGS. 14 and 15, thin elongated members are provided to initiate the formation of openings in the body tissue. The thin elongated members are also be utilized to guide movement of the anchors into the body tissue. Since the embodiment of the invention illustrated inFIGS. 14 and 15 is generally similar to the embodiments of the invention illustrated inFIGS. 1-13, similar numerals will be utilized to designate similar components, the suffix letter “d” being associated with the numerals ofFIGS. 14 and 15 to avoid confusion.
• Anapparatus10dincludes a plurality ofanchors18dand20dwhich are interconnected by asuture24d. Thesuture24dis formed as a continuous flexible loop, in the same manner as is illustrated inFIG. 11. However, thesuture24dcould have legs with free end portions, in the manner illustrated inFIG. 1.
• Atubular inserter28d(FIG. 14) cooperates with apusher member30dduring movement of theanchor18dinto body tissue. Similarly, atubular inserter38d(FIG. 15) cooperates with apusher member40dduring movement of the anchor into body tissue.
• When theanchor18d(FIG. 14) is to be positioned relative to body tissue, a thinelongated member146 is utilized to initiate formation of an opening in thebody tissue12dand14d. The thinelongated member146 may be a cylindrical rod similar to a K-wire. The thinelongated member146 has apointed end portion148.
• When theanchor18dis to be moved along a linear path in the body tissue14b, the thinelongated member146 will have the linear configuration illustrated inFIG. 14. When theanchor18dis to be moved along an arcuate path, the thinelongated member146 will have an arcuate configuration.
• When the thin elongated member146 (FIG. 14) is to be moved into thebody tissue12dand14d, the thinelongated member146 is positioned in a desired orientation relative to the body tissue. The thin elongated member is then forced axially into thebody tissue12dand14d. As the thinelongated member146 moves into thebody tissue12d, thepointed end portion148 of the thin elongated member initiates the formation of an opening in thebody tissue12d. As the thinelongated member146 moves through thebody tissue12d, thepointed end portion148 engages thebody tissue14dand initiates the formation of an opening thebody tissue14d.
• Once the thinelongated member146 has initiated the formation of an opening in thebody tissue14d, the thin elongated member is moved through the hardouter layer278dof bone into thecancellous bone280d. The thinelongated member146 is moved to a desired depth in thecancellous bone280d. The depth to which theelongated member146 is moved into thecancellous bone280dis somewhat greater than a depth to which theanchor18dis to be moved into the cancellous bone.
• Once the thinelongated member146 ahs been moved to the desired depth in thecancellous bone280d, theanchor18dis telescopically positioned relative to the stationary thinelongated member146. When this is done, the thinelongated member146 will extend through acylindrical passage152 in theanchor18d. Thepusher member30dis then positioned in a telescopic relationship with the stationary thinelongated member146. When this is done, the thinelongated member146 will extend through acylindrical passage156 in thepusher member30dand the throughpassage152 in theanchor18d. Thecylindrical inserter28dextends around thepusher member30dand a trailing end portion32dof theanchor18d.
• Thepusher member30d(FIG. 14) is pressed axially against the trailing end portion of theanchor18dto slide the pusher member and the anchor along the stationary thinelongated member146. As theanchor18dslides along the stationary thinelongated member146, a pointed leadingend portion34dof theanchor18dpierces thebody tissue12dand thebody tissue14d. When theanchor18dhas been moved to a desired position relative to thebody tissue14d, movement of the anchor along the thin elongated member is interrupted (FIG. 14).
• Theanchor20d(FIG. 15) is positioned relative to the body tissue in the same manner as theanchor18d. When theanchor20dis to be positioned relative to thebody tissue12dand14d, a second thin elongated member160 (FIG. 15) is positioned in a desired orientation relative to thebody tissue12dand14d. Apointed end portion162 of the thinelongated member160 is then forced into the body tissue. The thinelongated member160 may have a linear configuration or nonlinear configuration.
• Theanchor20dis then telescopically positioned on the stationary thinelongated member160. When this is done, the thinelongated member160 will extend through a cylindrical passage166 (FIG. 15) in theanchor20d. Theanchor20dis moved along the thinelongated member160 until a pointed leading end portion44dof theanchor20dengages thebody tissue12d. Apusher member40dis then telescopically moved along the thin elongated member into engagement with a trailingend portion42dof theanchor20d. Thepusher member40dthen applies force against the trailingend portion42dof theanchor20dto move the anchor into the body tissue to the position shown inFIG. 15.
• Once theanchors18dand20dhave been positioned in thebody tissue14d, the thinelongated members146 and160 are withdrawn from the anchors and from the body tissue. Theanchors18dand20dmay then be pivoted or toggled relative to each other to change their orientation relative to the body tissue. Alternatively, theanchors18dand20dmay be left in the orientation illustrated inFIG. 15.
• In the embodiment of the invention illustrated inFIG. 13, aguide assembly120 is utilized to position theguides126 and128 relative to the body tissue. A second embodiment of the guide assembly is illustrated inFIG. 16. Since the embodiment of the guide assembly illustrated inFIG. 16 is generally similar to the embodiment of the guide assembly illustrated inFIG. 13, similar numerals will be utilized to designate similar components, the suffix letter “e” being associated with the numeralsFIG. 16 to avoid confusion.
• Aguide assembly120eincludes a base124e. Tubular cylindrical guides126eand128eare provided on the base124e. Theguides126eand128eare utilized to guide movement of anchors, corresponding to theanchors18cand20cofFIG. 13. Theguides126eand128emay have either a linear or a nonlinear configuration depending upon the configuration of the paths along which the anchors are to be moved in theboy tissue12dand14d. When more than two anchors are to be positioned relative to thebody tissues12eand14e, a corresponding number of guides would be provided.
• In the embodiment of the invention illustrated inFIG. 16, theguides126eand128epenetrate both thebody tissue12eand thebody tissue14e. Thebody tissue14eis soft body tissue which is easily penetrated by theguides126eand128e. Alternatively, thebody tissue14ecould be hard body tissue which requires the application of a relatively large force against theguides126eand128eto cause them to penetrate the body tissue. Theguides126eand128ehaveslots292eand316eto receive portions of a suture.
• In the embodiment of the invention illustrated inFIGS. 1-10, the suture anchors18 and20 are utilized to connectsoft body tissue12 withhard body tissue14. In the embodiment of the invention illustrated inFIG. 17, the anchors are utilized to connect hard body tissue with hard body tissue. Since the embodiment of the guide assembly illustrated inFIG. 17 is generally similar to the embodiment of the invention illustrated inFIGS. 1-16, similar numerals will be utilized to designate similar components, the suffix letter “f” being associated with the numerals ofFIG. 17 to avoid confusion.
• First body tissue12f(FIG. 17) is connected with second body tissue14fwithanchors18fand20f. Asuture24fextends between theanchors18fand20f. Thebody tissue12fand14fare portions of abone174. Afracture178 extends across thebone174.
• Theanchors18fand20f(FIG. 17) are moved from one side of thebone174 to the opposite side of the bone to interconnect thebody tissue12fand14fwith thesuture24f. Aninserter38fand pusher member40fmay be utilized to move theanchors18fand20fthrough thebone12fand14f. The pusher member40fis effective to apply sufficient force against theanchors18fand20fto enable them to initiate the formation of openings in thebody tissue12fand14fand to enable them to be moved from one side of thebone174 to the opposite side of the bone.
• If desired, passages could be drilled through thebone174 prior to movement of theanchors18fand20fthrough the bone. If thin elongated members, corresponding to the thinelongated members146 and160 (FIG. 15) are to be used to guide theanchors18fand20f(FIG. 17), the drilled passages would have a relatively small diameter. If theanchors18fand20fare to be moved through thebone174 without thin elongated members, the drilled passages would have a larger diameter.
• In the embodiment of the invention illustrated inFIGS. 1-17, theanchors18 and20 all have the same general construction. However, it is contemplated that the anchors could have a construction similar to the construction of ananchor186 illustrated inFIG. 18. Theanchor186 includes abody190 from which a plurality ofbarbs192,194 and196 extend. Theanchor186 is connected with a portion of asuture200. Theanchor186 has a known construction and is merely illustrative of any one of many different types of anchors which may have projections, corresponding tobarbs192,194 and196, which engage body tissue. The projections may have a configuration which is substantially different than the configurations of thebarbs192,194 and196.
• It should be understood that the anchor could have a construction which is different than the construction of theanchors18,20 and186. For example, the anchor could have a construction similar to the construction of an anchor204 (FIG. 19). Theanchor204 has a threadedportion206 which engages body tissue.
• In the embodiments of the invention illustrated inFIGS. 1-19, the various anchors are connected with the body tissue in a spaced apart relationship. In the embodiment of the invention illustrated inFIGS. 20 and 21, the anchors are interconnected while they are in the body tissue. Since the embodiment of the invention illustrated inFIGS. 20 and 21 is generally similar to the embodiments of the invention illustrated inFIGS. 1-19, similar numerals will be utilized to designate similar components, the suffix letter “g” being associated with the numerals ofFIG. 20 to avoid confusion.
• Anapparatus10g(FIG. 20) is utilized to securebody tissue12gto body tissue14g. Theapparatus10gincludes ananchor18gand ananchor20g. Asuture24gextends between theanchors18gand20g.
• Thesuture24gincludes afirst leg portion50gwhich extends from thesuture18gand a second leg portion52gwhich extends from theanchor20g. The twoleg portions50gand52gof thesuture24gare interconnected by aretainer54g. In the embodiment of the invention illustrated inFIG. 20, theleg portions50gand52gof thesuture24gare two separate pieces of suture. However, theleg portions50gand52gmay be formed as one piece.
• Theanchor18gand theanchor20gengage each other in the body tissue14g. Portions of theanchors18gand20gcooperate to interconnect the anchors and hold them against movement relative to each other. Thus, theanchor18ghas projections212 (FIG. 21) which engageprojections214 on theanchor20g.
• Theprojections212 and214 (FIG. 21) on theanchors18gand20gintermesh in such a manner as to prevent the anchors from being moved relative to each other under the influence of tension in theleg portions50gand52gof thesuture24g. Althoughspecific projections212 and214 have been illustrated inFIG. 21, it is contemplated that theprojections212 and214 could have a different configuration if desired.
• In the embodiment of the invention illustrated inFIGS. 20 and 21, theanchors18gand20gare interconnected by engagement ofprojections212 and214 on the anchors. In the embodiment of the invention illustrated inFIG. 22, the anchors are interconnected by moving a portion of one anchor into an opening in the other anchor. Since the embodiment of the invention illustrated inFIG. 22 is generally similar to the embodiment of the invention illustrated inFIGS. 20 and 21, similar numerals will be utilized to designate similar components, the suffix letter “h” being associated with the numerals ofFIG. 22 to avoid confusion.
• Ananchor18hand ananchor20hare connected with a suture24h. The suture24hincludes aleg portion50hwhich is connected to and extends from theanchor18h. The suture24halso includes aleg portion52hwhich is connected to and extends from theanchor20h. Theleg portions50hand52hmay be interconnected by a retainer, corresponding to theretainer54gofFIG. 20. Alternatively, theleg portions50hand52hmay be integrally formed as one piece.
• In accordance with a feature of this embodiment of the invention, theanchor18his provided with an opening220 (FIG. 22) through which a portion of theanchor20hextends. Theanchor20hhasretainers224 which move through theopening220 and engage theanchor18hwhen theanchors18hand20hare disposed in body tissue14h. Engagement of theretainers224 with theanchor18hinterconnects theanchors18hand20h.
• In the embodiments of the invention illustrated inFIGS. 1-15, the anchors are enclosed by thebody tissue14. In the embodiment of the invention illustrated inFIG. 23, the anchor is partially disposed outside ofbody tissue12 and14. Since the embodiment of the invention illustrated inFIG. 23 is generally similar to the embodiments of the invention illustrated inFIGS. 1-22, similar numerals will be utilized to designate similar components, the suffix letter “j” being associated with the numerals ofFIG. 23 to avoid confusion.
• Anapparatus10j(FIG. 23) includes a plurality of anchors. The plurality of anchors includes theanchor18jand ananchor20j. Asuture24jextends between theanchors18jand20j. A greater number of anchors could be provided if desired.
• Theanchor18jhas ashank portion230 which extends throughbody tissue12jinto body tissue14j. If desired, theshank portion230 of theanchor18jcould extend through the body tissue14j. Ahead end portion234 of theanchor230 is pressed against thebody tissue12jand presses thebody tissue12jagainst the body tissue14j.
• Similarly, theanchor20jincludes ashank portion238 which extends through thebody tissue12jinto the body tissue14j. If desired, theshank portion238 of theanchor20jcould extend through the body tissue14j. Theanchor20jhas ahead end portion242 which is pressed against thebody tissue12j.
• Thesuture24jextends around theshank portions230 and238 of theanchors18jand20j. Thesuture24jengages theshank portions230 and238 of theanchors18jand20jat a location immediately beneath (as viewed inFIG. 23) thehead end portions234 and242 of theanchors18jand20j.
• Thesuture24jis formed as a continuous loop. The loop extends around theshank portions230 and238 of theanchors18jand20j. The continuous loop formed by thesuture24jis generally similar to the loop formed by thesuture24aofFIG. 11. However, if desired, thesuture24j(FIG. 23) could be a single strand which extends between the twoanchors18jand20j. Alternatively, thesuture24jcould be formed with two leg portions, corresponding to theleg portions50 and52 (FIG. 9) of thesuture24. If thesuture24j(FIG. 23) is formed with a pair of leg portions, the leg portions could be interconnected with a retainer, similar to theretainer54 ofFIG. 9.
Embodiment of FIGS.1-10
• In the embodiment of the invention illustrated inFIGS. 1-10, the apparatus10 (FIG. 1) includes a plurality of anchors which are interconnected by asuture24. Although only twoanchors18 and20 have been illustrated inFIG. 1, it should be understood that a greater number of anchors could be connected with thesuture24. In the embodiment of the invention illustrated inFIG. 1, theanchors18 and20 both have the same construction. However, it is contemplated that theanchor18 could have a construction which is different than a construction of theanchor20.
• Theanchor18 includes abody portion250 from which the pointed leadingend portion34 extends. Thespecific anchor18 illustrated inFIG. 1 has acylindrical body portion250 and a generally conical pointed leadingend portion34 which are disposed in a coaxial relationship.
• Although the pointed leadingend portion34 of the anchor18 (FIG. 1) has a conical configuration, the pointed leading end portion could have a different configuration if desired. For example the pointed leadingend portion34 could be wedge-shaped. Alternatively, the pointed leadingend portion34 could have a pyramidal configuration and be formed by the intersection three, four, or more surfaces. The surfaces could be flat or concave in configuration.
• Theanchor18 is provided with a pair ofpassages254 and256 through which thesuture24 extends. Thepassages254 and256 have a cylindrical configuration and extend diametrically through thecylindrical body portion250. Central axes of thepassages254 and256 extend parallel to each other and intersect acentral axis260 of the anchor. The central axes of thepassages254 and256 extend perpendicular to thecentral axis260 of theanchor18.
• In the illustrated embodiment of theanchor18, twopassages254 and256 extend diametrically through thebody portion250 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 to thecentral axis260 of theanchor18. Alternatively, the passage could extend axially through the anchor.
• The anchor20 (FIG. 1) is identical to theanchor18. Theanchor20 has acylindrical body portion264 through whichpassages266 and268 extend. Theanchor20 has aconical end portion44 which is coaxial with thecylindrical body portion264.
• Theanchors18 and20 maybe formed of many different materials. However, theanchors18 and20 are formed of bone, specifically, hard compact bone (cortical bone). The bone from which theanchors18 and20 are formed may be autogenic bone or allogenic bone. Alternatively, the anchors may be formed of xenogenic bone.
• Theanchors18 and20 may be formed of bone obtained from many different sources. However, it is believed that it may be preferred to form theanchors18 and20 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 theanchors18 and20 could be obtained in any one of many different ways under any one of many different conditions.
• Although theanchors18 and20 are formed of bone, theanchors18 and20 may be formed of other materials if desired. Theanchors18 and20 may be formed of biodegradable or non-biodegradable materials. For example, theanchors18 and20 may be formed of polycaperlactone. Alternatively, theanchors18 and20 may be formed of metal, such as titanium or stainless steel. If desired, theanchors18 and20 could be formed of biodegradable or bioerodible copolymers. It is believed that it may be desired to form theanchors18 and20 of bone or polymeric materials in order to minimize any possibility of interference with imaging systems such as magnetic resonance imaging systems.
• Theanchors18 and20 have the same construction as disclosed in co-pending U.S. patent application Ser. No. 09/556,458 filed May 3, 2000 by Peter M. Bonutti and entitled “Method and Apparatus for Securing Tissue”. However, it should be understood that theanchors18 and20 may be constructed with a different configuration if desired. For example, theanchors18 and20 may have a construction of any one of the anchors disclosed in U.S. Pat. No. 5,527,343 or 5,534,012. The disclosure in the aforementioned U.S. patent application Ser. No. 09/556,458 and the aforementioned U.S. Pat. Nos. 5,527,343 and 5,534,012 are hereby incorporated herein in their entirety by this reference thereto.
• It is contemplated that theanchors18 and20 will be used in situations where the anchors are exposed to body fluids. In such a situation, theanchors18 and20 may be formed of a material which absorbs body fluids and expands. Theanchors18 and20 may be formed of a polymeric material which absorbs body liquid. The polymeric material may be hydrophilic. The polymeric material may be cellulose, petroylglutamic acid, high purity carboxymethylcellulose, a collagen, or polylactide. Of course, theanchors18 and20 could be formed of other materials which absorb body liquid.
• When theanchors18 and20 are to absorb body liquid and expand, it is contemplated that the anchors may be constructed in accordance with the disclosure in U.S. Pat. No. 5,718,717 issued Feb. 17, 1998 to Peter M. Bonutti and entitled “Suture Anchor”. The disclosure in the aforementioned U.S. Pat. No. 5,718,717 is hereby incorporated herein in its entirety by this reference thereto.
• The suture24 (FIG. 1) extends from theanchors18 and20. Thesuture24 extends through thepassages254 and256 in theanchor18. Similarly, thesuture24 extends through thepassages266 and268 in theanchor20.
• Thesuture24 is freely movable relative to theanchors18 and20. By being freely movable relative in theanchor passages254,256,266 and268, the length of the suture between theanchors18 and20 can be varied to accommodate positioning of the anchors at different locations in a patient's body. Thus, by pulling on theleg portions50 and52 of thesuture24, the length of the connector portion48 (FIG. 1) of thesuture24 extending between the anchors can be shortened to accommodate positioning of the anchors in thebody tissue14 at the locations which are relatively close together. Similarly, theanchors18 and20 can be pulled apart to lengthen theconnector portion48 of thesuture24 to accommodate positioning of theanchors18 and20 in thebody tissue14 at locations which are spaced a substantial distance apart.
• Once theanchors18 and20 have been positioned in body tissue, in the manner illustrated inFIG. 9, force applied to theleg portions50 and52 is effective to tension theconnector portion48 of thesuture24. Any excess material in theconnector portion48 of thesuture24 will be pulled into theleg portions50 and52 as the leg portions and connector portion are tensioned. This results in theleg portions50 and52 andconnector portion48 of thesuture24 being tensioned with substantially the same force by the force application assembly60 (FIG. 10) prior to gripping of theleg portions50 and52 of thesuture24 with thesuture retainer54.
• Since thesuture24 is movable relative to theanchors18 and20, the tension in the connector portion48 (FIG. 9) of thesuture24 can be increased after theanchors18 and20 have been positioned in thebody tissue14. Thus, once theanchors18 and20 have been moved to the positions illustrated inFIG. 9, pulling on theleg portions50 and52 of thesuture24 causes the suture to slide in thepassages254 and256 in theanchor18 and to slide in thepassages266 and268 in theanchor20. As thesuture24 moves in thepassages254,256,266 and268 in theanchors18 and20, the length of theconnector portion48 of thesuture24 decreases. At the same time the length of theleg portions50 and52 increase.
• Pulling on theleg portions50 and52 of theflexible suture24 increases the tension in the leg portions. This increase in tension is transmitted from theleg portions50 and52 of thesuture24 through thepassages254,256,266 and268 in theanchors18 and20 to theconnector portion48 of the suture. Therefore, pulling on theleg portions50 and52 of thesuture24 eliminates any extra length in theconnector portion48 of the suture and effects a corresponding increase in the combined lengths of the leg portions of the suture. As this occurs, tension in theconnector portion48 of thesuture24 increases to equal tension in theleg portions50 and52 of the suture.
• Thesuture24 may be formed of a plastic material which is a biopolymer. Thus, thesuture24 may be formed of polyglycolide which is commercially available under the trademark DEXON. Polyglycolide is a crystalline material that melts about 225° Celsius. Although thesuture24 is a monofilament suture having a continuous outer side surface, it is contemplated that the suture could be formed in a different manner. For example, thesuture24 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. If desired, thesuture24 and anchors18 and20 could be formed of the same polymeric material.
• It is contemplated that thesuture24 may be formed of a polyglycolide-based copolymer which is commercially available under the trademark VICRYL. Thesuture24 may have a multifilament construction which is similar to the construction of the suture disclosed in U.S. Pat. No. 5,928,267. The disclosure in the aforementioned U.S. Pat. No. 5,928,267 is hereby incorporated herein by this reference thereto.
• The strength of thesuture24 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 whether the suture has a monofilament or multifilament construction. By consulting a chart, a surgeon can select asuture24 of a size and strength suitable for a particular use. Thus, a relativelylarge size suture24 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 relativelysmall size suture24 having a relatively small strength may be selected when delicate body tissue, such as stomach tissue or intestinal tissue, and/or mucosa are to be interconnected with the suture.
• Once a suture of a size and strength suitable for retaining specific body tissue has been selected, the suture is threaded through thepassages254 and256 in theanchor18 through thepassages266 and268 in theanchor20. By moving theanchors18 and20 away from each other, the length of theconnector section48 can be increased. Alternatively, by tensioning theleg portions50 and52 (FIG. 1) of thesuture24, the length of theconnector portion48 can be decreased.
• In the embodiment of the invention illustrated inFIGS. 1-10, thesuture24 and anchors18 and20 are formed of different materials. Thus, theanchors18 and20 are formed of bone while thesuture24 is a monofilament of polymeric material. However, it is contemplated that both thesuture24 and theanchors18 and20 could be formed of similar materials. For example, thesuture24 and anchors18 and20 could both be formed of polymers or copolymers which are biodegradable or bioerodible. Even when theanchors18 and20 are formed of metal, it may be desirable to form thesuture24 of a biodegradable polymeric material.
• Theanchors18 and20 could have many different constructions. For example, theanchors18 and20 could be constructed in the manner illustrated inFIGS. 18-23 herein. Alternatively, theanchors18 and20 have any of the constructions disclosed in U.S. Pat. Nos. 5,403,348 and 5,989,282. If desired, theanchors18 and20 could have different constructions. The disclosures in the aforementioned U.S. Pat. Nos. 5,403,348 and 5,989,282 are hereby incorporated herein in their entirety by this reference thereto.
• After theanchors18 and20 have been connected with thesuture24, in the manner illustrated inFIG. 1, the anchors and suture are used to connectbody tissue12 with thebody tissue14. In the specific embodiment of the invention illustrated inFIGS. 1-10, thebody tissue12 is soft body tissue and thebody tissue14 is hard body tissue. Thesoft body tissue12 may be a tendon or a ligament. Thebody tissue14 is a bone having a hard (cortical)outer layer278 and relatively softcancellous bone280 which is enclosed by the relatively hardouter layer278.
• It should be understood that many different kinds of soft tissue can be connected with bone at many different locations in a patient's body. For example, theanchors18 and20 andsuture24 could be used to secure a meniscus to a bone in a knee joint of a patient. Alternatively, thesuture24 and anchors18 and20 could be used to secure the rotator cuff in a shoulder of a patient. Thesoft tissue12 may be mucosa. Thesoft tissue12 may be musculofascial tissue. It should be understood that the foregoing specific locations for use of theapparatus10 in the body of a patient have been set forth herein merely as examples and it is contemplated that theapparatus10 may be used at any desired location in the body of a patient.
• In the embodiment of the invention illustrated inFIGS. 1-10, thebody tissue12 is pressed against thebody tissue14 by force transmitted from thesuture24 to thebody tissue12. However, thebody tissue12 could be spaced from thebody tissue14. For example, thesuture24 could extend at least part way around thebody tissue12 with thebody tissue12 spaced from thebody tissue14. Thebody tissue12 could be soft body tissue which has a range of movement, relative to thebody tissue14, limited by thesuture24. Thebody tissue14 could be either hard body tissue (bone) or soft body tissue. Alternatively, theanchor18 could be disposed in one bone and theanchor20 disposed in another bone. If this was done, thesuture24 could be utilized to limit the range of movement between the bones or to hold the bones in engagement with each other.
• It is contemplated that thesuture24 and anchors18 and20 may be used in vascular tissue. For example, theanchors18 and20 could be used to connect thesuture24 with body tissue which forms a portion of a blood vessel. Body tissue forming two sections of a blood vessel may be placed in a side-by-side relationship and interconnected with theanchors18 and20 and thesuture24.
• When thebody tissue12 is to be secured to thebody tissue14 with theapparatus10, theanchor18 is positioned in the inserter28 (FIG. 2). The illustratedinserter28 includes a cylindrical tubularouter member284 which is connected with a suitable handle (not shown). Thepusher member30 has a generally cylindrical configuration and is received in acylindrical passage286 in the tubularouter member284.
• Thecylindrical passage286 extends between an entrance opening adjacent to the handle and acircular exit opening288. Thepusher member30 extends along thepassage286 through the opening adjacent to the handle of theouter member284. Although the illustratedinserter28 andpusher member30 have linear central axes, they could have nonlinear central axes if desired. For example, theinserter28 andpusher member30 could have arcuate central axes.
• Aslot292 extends between the entrance opening adjacent to the handle of theinserter28 and theexit opening288. Theslot292 facilitates positioning theanchor18 in thepassage286. This is because theanchor18 is visible through theslot292. In addition, theconnector portion48 andleg portion50 of thesuture24 can be readily positioned in theslot292.
• Theslot292 has a straight longitudinal central axis which extends parallel to the longitudinal central axis of thepassage286 and to the longitudinal central axis of the tubularouter member284. Theconnector portion48 andleg portion50 of thesuture24 extend along theslot292 away from theopening288 toward the opposite end portion of the tubularouter member284. Theslot292 encloses theconnector portion48 andleg portion50 of thesuture24 and protects theconnector portion48 and leg portion of thesuture24 against being snagged by objects in the environment around theinserter28.
• Thepassage286 has a circular cross sectional configuration with a diameter which is slightly greater than the diameter of thebody portion250 of theanchor18. Immediately adjacent to theexit opening288, thepassage286 tapers inwardly to a cross sectional size which is somewhat smaller than the cross sectional size of thebody portion250 of theanchor18. This enables theouter member284 to firmly grip the trailingend portion32 of theanchor18.
• Theslot292 has a uniform width throughout the length of the slot until the slot approaches theexit opening288. Immediately ahead of theexit opening288, the width of theslot292 decreases to reduce the cross sectional size of thepassage286.
• When theanchor18 is to be positioned in theinserter28, the anchor is inserted through the opening to thepassage286 adjacent to the handle with theend portion34 of the anchor leading. Thepusher member30 is moved into thepassage286 and applies force against the trailingend portion32 of theanchor18 to move the anchor along thepassage286. At this time, theconnector portion48 andleg portion50 of thesuture24 are disposed in theslot292.
• When theanchor18 approaches theexit opening288, the taperedleading end portion34 of the anchor applies force against theouter member284 to resiliently deflect the end portion of the outer member and expand theexit opening288. At this time, the portion of theouter member284 adjacent to theexit opening288 resiliently grips thebody portion250 of the anchor to hold the anchor in the position illustrated inFIG. 2.
• Although theinserter28 may have many different constructions, thespecific inserter28 illustrated inFIG. 2 has the same construction as is disclosed in U.S. Pat. No. 5,948,002 issued Sep. 7, 1999 for “Apparatus and Method for Use in Positioning a Suture Anchor”. It should be understood that theinserter28 may have a construction which is similar to any one of the constructions illustrated in the aforementioned U.S. Pat. No. 5,948,002. It is also contemplated that theinserter28 could have a construction which is similar to the construction of any one of many other known inserters. However, it is believed that it may be desired to use an inserter having the construction disclosure in the aforementioned U.S. Pat. No. 5,948,002 to facilitate handling and positioning of theanchor18 relative to thebody tissue12 and14. The disclosure in U.S. Pat. No. 5,948,002 is hereby incorporated herein by this reference thereto.
• Theanchor18 is held in theinserter28 with theleading end portion34 of the anchor extending from the inserter. Thepusher member30 engages the trailingend portion32 of theanchor18 to block movement of the anchor along thepassage286 in a direction away from theexit opening288.
• The longitudinal central axis of theinserter28 is then positioned in an orientation relative to thebody tissue12 corresponding to the orientation of a path along which the anchor is to be moved into the body tissue. Thus, if theanchor18 is to be moved straight downward (as viewed inFIG. 2) into thebody tissue12 and into thebody tissue14, theinserter28 would be positioned with its longitudinal central axis extending generally perpendicular to anouter surface300 of thebody tissue12. However, in the embodiment of the invention illustrated inFIGS. 1-10, it is desired to move theanchor18 into thebody tissue12 and14 along a path which is skewed at an acute angle to theouter surface30 of thebody tissue12.
• In the specific instance illustrated inFIG. 2, theinserter28 is positioned with its longitudinal axis extending at an angle of approximately 40° to theouter surface300 of thebody tissue12. However, it is contemplated that theinserter28 could be positioned with its longitudinal axis extending at an angle of between 30° and 90° to theouter surface300 of thebody tissue12. The specific angle which is selected between theouter surface300 of thebody tissue12 and the longitudinal central axis of theinserter28 will depend upon the desired path of movement of theanchor18 into the body tissue. It is believed that it may be desired to have the path of movement of theanchor18 into thebody tissue12 and14 at an angle of between 30° and 70° to theouter surface300 of the body tissue.
• It is believed that it will be desired to move theanchor18 for a predetermined distance into thebody tissue14. It is also believed that it may be desired to limit the depth of movement of the anchor into thebody tissue14. In order to enable the anchor to be moved through a substantial distance into thebody tissue14 while minimizing the depth to which the anchor is moved into the body tissue, the path of movement of the anchor into the body tissue is skewed at an acute angle to theouter surface300 of thebody tissue12. When theanchor18 is to be moved along a path which is skewed relative to theouter surface300, it is believed that it may be desired to move the anchor into thebody tissue12 and14 at an angle of between 30° and 70° to theouter surface300 of the body tissue.
• Once a desired angle for the path of movement of theanchor18 through thebody tissue12 and into thebody tissue14 has been selected, theinserter28 andpusher member30 are moved toward theouter surface300 of thebody tissue12 with the anchor extending from the inserter, in the manner illustrated inFIG. 2. The pointedleading end portion34 of theanchor18 is moved into engagement with an imperforate area on theouter surface300 of thebody tissue12. As theinserter28 andpusher member300 continue to move along their longitudinal central axes toward thebody tissue12, the pointed leadingend portion34 of theanchor18 initiates the formation of an opening in theouter surface300 of thebody tissue12.
• Continued movement of theinserter28 andpusher member30 toward thebody tissue12 causes theanchor18 to piercebody tissue12. As theanchor18 moves through thebody tissue12, the pointed leading end portion of the anchor moves into engagement with an imperforate area on anouter surface304 of the hardouter layer278 of thebone14. It should be understood that thebody tissue12 could have a thickness which is greater than the thickness illustrated schematically inFIG. 2. It is contemplated that thebody tissue12 could have a thickness which is substantially greater than the axial extent of theanchor18.
• The pointedleading end portion34 of theanchor18 then initiates the formation of an opening in an imperforate area on thesurface304 on the hardouter layer278 of the bone. Continued movement of theinserter28 along its path of movement moves theleading end portion34 of the anchor into the hardouter layer278 of the bone, in the manner illustrated schematically inFIG. 3. As this occurs, theinserter28 moves through thesoft tissue12 into abutting engagement with theouter surface304 on the hardouter layer278 of thebone14.
• The axial force applied against theinserter28 is insufficient to cause the inserter to penetrate the hardouter layer278 of thebone14. Therefore, movement of theinserter28 along its longitudinal central axis relative to thebody tissue12 and14 is interrupted when the leading end portion of the inserter engages theouter surface304 of the hardouter layer278 of thebone14. At this time, theleading end portion34 of theanchor18 will have initiated penetration of theouter layer278 of the bone14 (FIG. 3).
• The movement of the inserter along the path of insertion of theanchor18 into thebody tissue12 and14 has been illustrated inFIG. 3 as being interrupted when the inserter engagesouter surface304 of thebone14. However, it is contemplated that movement of theinserter28 along the path of insertion of theanchor18 could be interrupted when the inserter engages theouter surface300 on thebody tissue12. If this was done, the inserter would be moved from the position illustrated inFIG. 2 along the path of movement of theanchor18 into thebody tissue12 and14 until the leading of the inserter engaged theouter surface300 of thebody tissue12. At this time, theleading end portion34 of theanchor18 may or may not have moved into engagement with thebone14. Whether or not the anchor has moved into engagement with thebone14 when theinserter28 engages theouter surface300 of thebody tissue12 will depend upon the thickness of thebody tissue12, the angle of the path of movement of the anchor relative to thebody tissue12, and the distance which theanchor18 extends from theinserter28.
• When thetissue12 is soft tissue and thetissue14 is bone or other hard body tissue, it is believed that it will be desirable to have the inserter move with theanchor18 during initiation of penetration of the anchor into the hard body tissue. However, when thebody tissue14 is soft body tissue, it may not be desired to have the inserter hold the trailingend portion32 of the anchor during initiation of penetration of the anchor into thebody tissue14.
• It is contemplated that it may be desired to move theinserter28 into thebone14. Thus, theinserter28 could be moved through the hardouter layer278 of thebone14 into thecancellous bone280. This would have the advantage of enabling theinserter28 to at least partially support theanchor18 as the anchor moves through the hardouter layer278 of thebone14.
• In the embodiment of the invention illustrated inFIGS. 1-10, thebody tissue14 is hard body tissue, that is, bone. It is believed that initiation of penetration of the anchor into the hardouter layer278 of thebone14 will be facilitated by having the anchor held in theinserter28 as the pointed leadingend portion34 begins to move through the imperforateouter surface304 of theouter layer278. Therefore, it is believed that it may be desired to move theinserter28 through thesoft body tissue12 into engagement with theouter surface304 of thebone14 during at least the initiation of formation of an opening in the hardouter layer278 of thebone14.
• Once theinserter28 has moved into engagement with theouter surface304 of thebone14 and movement of the inserter relative to thebone14 is interrupted, thepusher member30 is moved relative to theinserter28 to apply force against the trailingend portion32 of the anchor and to move the anchor further into thebone14, in the manner illustrated inFIG. 4. Thus, theinserter28 is held stationary relative to thebody tissue12 and14 while thepusher member30 is moved axially along the longitudinal central axis of theinserter28. The pusher member is telescopically extended from theinserter28 and moves theanchor18 through the hardouter layer278 of thebone14 into the relatively soft cancellous bone280 (FIG. 4).
• As this occurs, thesuture24 moves along theslot292 in theinserter28. As theanchor18 moves into thebone14, the anchor pulls thesuture24 into the bone. This results in movement of thesuture24 along theslot292 in theinserter28. As theanchor18 moves into thecancellous bone280, theleading end portion34 of the anchor pierces the cancellous bone.
• Theanchor18 is moved into thebody tissue12 and14 along an insertion path which is skewed at an acute angle to theouter surface300 of thebody tissue12 and theouter surface304 of thebody tissue14. Therefore, the distance which theanchor18 is moved into thebone14 tends to be maximized while the depth, as measured perpendicular to theouter surfaces300 and304 of thebody tissue12 and14, of insertion of the anchor is minimized.
• If theinserter28 was positioned in engagement with theouter surface304 of thebone14 with the longitudinal central axis of the inserter extending perpendicular to the outer surface of the bone, and if thepusher member300 was moved through the same distance relative to theinserter28 from the retracted condition shown inFIG. 3 to the extended condition shown inFIG. 4, theanchor18 would be moved further into thebone14 as measured along a path extending perpendicular to theouter surface304 of the bone. It is believed that in at least some locations in a patient's body, it will be desired to have the distance which the anchor is moved into thebone14 maximized while at the same time minimizing the depth of penetration of the anchor. This may be due to thebone14 being relatively thin, the particular configuration of thebone14, or other causes.
• In order to increase the resistance of the anchor to pull out under the influence of tension forces in thesuture24, the anchor is toggled or pivoted from the orientation illustrated inFIG. 4 to the orientation illustrated inFIG. 5. This results in the anchor being moved from a position in which a longitudinal central axis of the anchor is aligned with the longitudinal central axis of a path of movement of the anchor into the bone14 (FIG. 4) to a position in which the longitudinal central axis of the anchor is skewed relative to the path of movement of the anchor into the bone14 (FIG. 5).
• Once theanchor18 has been moved to the desired depth in the bone14 (FIG. 4), toggling movement of the anchor is initiated by tensioning theconnector portion48 andleg portion50 of thesuture24. A sloping orbevel surface310 is provided on the leading end portion of thepusher member30 to facilitate initiation of the pivotal movement of theanchor18 relative to thepusher member30. The force applied against theanchor18 by thesuture24 pulls the anchor back or upward (as viewed inFIG. 4) toward thesurface310 on thepusher member30. Therefore, the tension in thesuture24 tends to rotate theanchor18 in a counterclockwise direction from the position illustrated inFIG. 4 to the position illustrated inFIG. 5 relative to the softcancellous bone280.
• As theanchor18 is pivoted, the upper (as viewed inFIG. 5) portion of the anchor deflects the softcancellous bone tissue280. The viscoelastic nature of the softcancellous bone tissue280 causes the tissue to tend to close behind the anchor as it is pivoted upward to the position shown inFIG. 5. The manner in which theanchor18 is pivoted relative to the body tissue is similar to that disclosed in U.S. Pat. Nos. 5,948,002; 5,941,900; and 5,403,348.
• Once theanchor18 has been moved to the position illustrated inFIG. 5, thepusher member30 is withdrawn from thebody tissue12 and14. This results in theanchor18 being supported in thebody tissue12 and14 by thecancellous bone280. Theanchor18 is spaced from the hardouter layer278 of thebone14. Therefore, tension forces in thesuture24 are transmitted from outer side surfaces of the anchor to thecancellous bone280 while the anchor is maintained in a spaced apart relationship with the hardouter layer278 of bone. The manner in which theanchor18 is supported in thecancellous bone280 in a spaced apart relationship with the hardouter layer278 of bone is the same as is disclosed in U.S. Pat. No. 6,077,292.
• Rotating theanchor18 relative to the path of movement of the anchor into thebody tissue12 and14 increases the resistance of the anchor to pull out forces transmitted through thesuture24 to the anchor. Theanchor18 could remain in thebone14 in the orientation shown inFIG. 4 in which the longitudinal central axis of the anchor is coincident with the longitudinal central axis of the path along which the anchor moves into the bone. However, by toggling or pivoting the anchor from the position shown inFIG. 4 to the position shown inFIG. 5 the resistance of the anchor to pull out forces tends to be increased. Of course, if the anchor is to be subjected to only relatively small pull out forces, the anchor could be left in the position shown inFIG. 4 relative to thebone14 without being pivoted to the orientation illustrated inFIG. 5.
• In the embodiment of the invention illustrated inFIGS. 1-10, theanchor18 is moved into thebody tissue12 and14 from the initial position ofFIG. 2 to the intermediate position ofFIG. 4 along a linear path. However, theanchor18 could be moved from the initial position (FIG. 2) to the intermediate position (FIG. 4) along a nonlinear path if desired. For example, theanchor18 could be moved along an arcuate path from the initial position to the intermediate position.
• When theanchor18 is to be moved along an arcuate path from the initial position (FIG. 2) to the intermediate position (FIG. 4), theinserter28 andpusher member30 may be formed with an arcuate configuration. The arcuate configuration of theinserter28 andpusher member30 would be the same as the arcuate configuration of the path along which theanchor18 is to be moved into thebody tissue12 and14.
• When theinserter28 andpusher member30 have a rigid construction, it is believed that it may be desired to form thepassage286 in the inserter and to form thepusher member30 to have the same arc of curvature. This is done to facilitate movement of thepusher member30 along thepassage286 in theinserter28. However, it is contemplated that theinserter28 and/orpusher member30 could have a flexible construction if desired. For example, theinserter28 andpusher member30 could have a construction similar to the construction disclosed in U.S. Pat. No. 5,897,574. The disclosure in U.S. Pat. No. 5,897,574 is hereby included herein in its entirety by this reference thereto.
• Theanchor20 is moved through thesoft body tissue12 into thehard body tissue14 in the same manner as in which theanchor18 is moved through the soft body tissue into the hard body tissue. Thus, theanchor20 is positioned in an inserter38 (FIG. 6) having the same construction as theinserter28 ofFIG. 3. A pusher member40 (FIG. 6) is telescopically moved along theinserter38 into engagement with the trailingend portion42 of theanchor20 in the same manner as previously described in conjunction with theanchor18,pusher member30 andinserter28 ofFIG. 3.
• Theleg portion52 of thesuture24 and theconnector portion48 of the suture are at least partially received in aslot316 in theinserter38 in the same manner as in which the suture is received in theslot292 in theinserter28 ofFIG. 3. Theinserter38 andpusher member40 have the same construction and cooperate in the same manner as is disclosed in U.S. Pat. No. 5,948,002 and have the same construction and mode of operation as theinserter28 andpusher member30 ofFIGS. 2-4.
• When theanchor20 is to be used in securing thebody tissue12 to thebody tissue14, theanchor20 is positioned in theinserter38 and thepusher member40 is moved into engagement with the trailing end portion of the anchor. Theleading end portion44 of the anchor is then moved from a position spaced from thebody tissue12 to a position in which the leading end portion engages an imperforate area on theouter surface300 of thebody tissue12. At this time, theinserter38 andpusher member40 are positioned in an angular orientation relative to thesurface300 of thebody tissue12 corresponding to the angle of the desired path of insertion of theanchor20 into thebody tissue12 and14.
• In the specific situation illustrated inFIG. 6, the path of insertion of theanchor20 into thebody tissue12 and14 is skewed at an acute angle of approximately 40° relative to thesurface300 of thebody tissue12. It is contemplated that the path of insertion of theanchor20 into thebody tissue12 and14 may be located an at angle between 30° and 90° relative to thesurface300 of thebody tissue12. In order to reduce the depth of insertion of theanchor20 into thebone14, it is believed that it may be desired to have the path of movement of theanchor20 into thebody tissue12 and14 skewed at an acute angle of between 30° and 70° relative to thesurface300 of thebody tissue12.
• When theinserter38 andpusher member40 have been positioned with their longitudinal central axes coincident with the longitudinal central axis of the desired path of movement of theanchor20 into thebody tissue12 and14, thepusher member40 andinserter38 are moved together toward thesurface300 of thebody tissue12. As this occurs, the pointed leadingend portion44 of theanchor20 initiates the formation of an opening in thesurface300 of thebody tissue12.
• Theinserter38,pusher member40, andanchor20 continue to move together relative to thebody tissue12 and14 as the anchor pierces thebody tissue12. When the pointed leadingend portion44 of theanchor20 engages an imperforate portion of theouter surface304 of thebone14, theleading end portion44 of the anchor initiates formation of an opening in theouter surface304 of thebone14.
• Continued movement of theinserter38,pusher member40 andanchor20 together along the path of insertion of the anchor into thebody tissue12 and14 results in theleading end portion44 of the anchor moving into the hardouter layer278 of thebone14 in the manner illustrated inFIG. 6. As this occurs, theinserter38 moves into engagement with theouter surface304 of thebone14. Movement of theinserter38 relative to thebone14 is interrupted with the inserter in engagement with theouter surface304 of the bone, in the manner illustrated schematically inFIG. 6.
• It may be desired to move theinserter38 through thebody tissue12 into engagement with thebone14, in the manner illustrated inFIG. 6. This results in theanchor20 being supported by theinserter38 as the anchor initially penetrates the hardouter layer278 of thebone14. Theanchor20,inserter38 andpusher member40 are moved together along the path of movement of the anchor into thebody tissue12 and14 until theinserter38 engages thesurface304 on the hardouter layer278 of the bone. By the time theinserter38 engages thesurface304 on the hardouter layer278 of thebone14, the leading end portion of the anchor has moved into the hard outer layer of the bone (FIG. 6).
• When theinserter38 moves into engagement with theouter surface304 of thebone14, movement of the inserter relative to the bone is interrupted. Thepusher member40 is then moved relative toinserter38. Movement of thepusher member40 relative to theinserter38 applies force against the trailingend portion42 of theanchor20 and moves theanchor20 into thebone14. Theanchor20 is moved into thebone14 through the hardouter layer278 and into thecancellous bone280 as thepusher member40 is telescopically extended from the inserter38 (FIG. 7). As theanchor20 moves into thebone14, thesuture24 moves along theslot316 in theinserter38.
• Once theanchor20 has been moved to the desired depth in thecancellous bone280, thepusher member40 andinserter38 may be withdrawn from thebody tissue12 and14 and the anchor left in the orientation illustrated inFIG. 7 relative to the body tissue. Thus, the anchor may remain in thecancellous bone280 with a longitudinalcentral axis320 of the anchor aligned with the central axis of the path of movement of the anchor into thebody tissue12 and14. Alternatively, the orientation of the anchor relative to the path of movement of the anchor into thebody tissue12 and14 may be changed to increase the resistance to the anchor to pull out forces transmitted through thesuture24.
• When the orientation of theanchor20 is to be changed relative to thebone14 from the orientation illustrated inFIG. 7 to the orientation illustrated inFIG. 8, thesuture24 is tensioned. Tensioning thesuture24 tends to pivot theanchor20 in a clockwise direction (as viewed inFIGS. 7 and 8) about a location where the trailingend portion42 of the anchor engages thepusher member40. Thepusher member40 has abevel surface324 which extends transversely to a longitudinal central axis of thepusher member40. Thebevel surface324 facilitates pivotal movement of theanchor20 relative to thepusher member40.
• When theanchor20 has been pivoted to the orientation illustrated inFIG. 8, thepusher member40 is telescopically moved back into theinserter38. Theinserter38 andpusher member40 are then withdrawn from thebody tissue12. When theanchor20 is in the orientation shown inFIG. 8, thecentral axis320 of the anchor extends transverse to the path of movement of the anchor into thebone14. This increases the pull out force which is required to remove the anchor from the bone.
• After theanchors18 and20 have been moved into the bone and toggled to the orientations illustrated inFIGS. 5 and 8, the anchors are pointed toward each other (FIG. 9). Thus, theleading end portion34 of theanchor18 points toward theanchor20 and theleading end portion44 of theanchor20 points toward theanchor18. At this time, the longitudinalcentral axis260 of theanchor18 extends generally parallel to theouter surface300 of thebody tissue12 and to theouter surface304 of thebone14. Similarly, thecentral axis320 of theanchor20 extends parallel to theouter surface300 of thebody tissue12 and to theouter surface304 of thebone14. At this time, both theanchors18 and20 are supported by thecancellous bone280 in a spaced apart relationship with the hardouter layer278 of thebone14.
• InFIG. 9, thecentral axes260 and320 of theanchors18 and20 are disposed in a plane which extends perpendicular to theouter surface300 of thebody tissue12 and theouter surface304 of thebody tissue14. However, it is contemplated that theaxes260 and320 of theanchors18 and20 could be offset relative to each other. For example, one of theaxes260 or320 could be offset from the other axis in a direction extending into the sheet on which the drawing ofFIG. 9 is disposed. In addition, rather than being generally parallel to theouter surfaces300 and304 of thebody tissue12 and14, theaxes260 and320 of theanchors18 and20 could be skewed at a greater angle relative to the outer surfaces of the body tissue.
• The paths of movement of theanchors18 and20 into thebody tissue12 and14 have central axes disposed in a plane which extends perpendicular to theouter surfaces300 and304 of thebody tissue12 and14. However, the path of movement of one of the anchors, for example, theanchor18, into thebody tissue12 and14 could have a central axis which is offset from the central axis of the path of movement of the other anchor into the body tissue.
• Regardless of whether or not the central axes of the paths along which theanchors18 and20 move into thebody tissue12 and14 are disposed in the same plane, it is believed that it may be desired to have the paths extend toward each other. Thus, the path along which theanchor18 moves into thebody tissue12 and14 extends toward the path along which theanchor20 moves into the body tissue. Even though the central axes of the paths along which the anchors move into the body tissue are not disposed in a common plane, theanchor18 moves toward the location where theanchor20 enters thebody tissue12 and14 as theanchor18 is moved into the body tissue. Similarly, theanchor20 moves toward locations where theanchor18 moved into thebody tissue12 and14 as theanchor20 is moved into the body tissue.
• By having theanchors18 and20 move along insertion paths which extend toward each other, even though central axes of the insertion paths may not be disposed in a common plane, the anchors approach each other as they move in the cancellous material of thebone14. This results in thesuture24 being effective to press thebody tissue12 against thebody tissue14 with a clinching action. The clinching action with which thesuture24 presses thebody tissue12 against thebone14 is similar to the clinching action which is obtained by the legs of a staple. This clinching action increases the force which is transmitted from thesuture24 to thebody tissue12 and increases the resistance of theanchors18 and20 to pull out under the influence of tension forces in the suture.
• Although it is believed that it may be desired to move theanchors18 and20 toward each other along their insertion paths to decrease the distance between the anchors as they move into thebody tissue14, the anchors could be moved along insertion paths which are either parallel or diverge. For example, the insertion path of theanchor18 into thebody tissue12 and14 could extend parallel to the insertion path of theanchor20 into the body tissue. If this was done, the insertion paths of theanchors18 and20 would have parallel central axes disposed in a plane extending perpendicular to theouter surfaces300 and304 of thebody tissue12 and14.
• Alternatively, it is contemplated that theanchors18 and20 could be moved into thebody tissue12 and14 along diverging insertion paths. Thus, theanchor18 could be moved along an insertion path which extends parallel to the illustrated insertion path of theanchor20 inFIG. 7. Similarly, theanchor20 could be moved along an insertion path which extends parallel to the insertion path of theanchor18 inFIG. 4. It should be understood that the angular orientation of the insertion paths for theanchors18 and20 relative to each other will depend upon the specific environment in which the anchors are utilized.
• In the embodiment of the invention illustrated inFIGS. 1-10, theanchor20 is moved into thebody tissue12 and14 from an initial position to the intermediate position ofFIG. 7 along a linear path. However, theanchor20 could be moved from the initial position to the intermediate position (FIG. 7) along a nonlinear path if desired. For example, theanchor20 could be moved along an arcuate path from the initial position to the intermediate position.
• When theanchor20 is to be moved along an arcuate path from the initial position to the intermediate position, theinserter38 andpusher member40 may be formed with an arcuate configuration. The arcuate configuration of theinserter38 andpusher member40 would be the same as the arcuate configuration of the path along which theanchor20 is to be moved into thebody tissue12 and14.
• When theinserter38 andpusher member40 have a rigid construction, it is believed that it may be desired to form the passage in the inserter and to form thepusher member40 to have the same arc of curvature. This is done to facilitate movement of thepusher member40 along the passage in theinserter38. However, it is contemplated that theinserter38 and/orpusher member40 could have a flexible construction if desired. For example, theinserter38 andpusher member40 could have a construction similar to the construction disclosed in U.S. Pat. No. 5,897,574.
• Once theanchors18 and20 have been moved to the position illustrated inFIG. 9, ends of theleg portions50 and52 of the suture are positioned in an opening in the retainer or crimp54. While theleg portions50 and52 of the suture are tensioned at a location above theretainer54, as viewed inFIG. 9, the retainer is moved downward toward thebody tissue12. As theretainer54 is moved downward toward thebody tissue12, the tension in theconnector portion48,leg portion50 andleg portion52 of the suture is increased.
• By initially providing theconnector portion48 of the suture with a length which is slightly less than the length illustrated inFIG. 9, theconnector portion48 of thesuture24 is tensioned as theanchor20 is moved into thebone14. This is because as theanchor20 moves into thebone14, the anchor pulls thesuture24 into the bone. If the connector portion of thesuture48 is shorter than is required when theanchors18 and20 have been moved to the positions illustrated inFIG. 9, the connector portion of thesuture48 is tensioned as theanchor20 moves into thebone14. This tensioning of theconnector portion48 of thesuture24 causes the suture to move relative to theanchor20 in thepassages266 and268. As this occurs, the length of theleg portion52 of thesuture24 is decreased and the length of theconnector portion48 of the suture is increased.
• After theanchors18 and20 have been positioned in thebody tissue14, the surgeon pulls on the free end of theleg portions50 and52 and moves theretainer54 toward thebody tissue12. As this occurs, theleg portions50 and52 of thesuture24 are tensioned. Any excess material in theconnector portion48 of thesuture24 is pulled from theconnector portion48 by movement of the suture relative to theanchors18 and20 and a resulting increasing of the overall length of theleg portions50 and52. Since thesuture24 is movable in thepassages254,256,266 and268 in theanchors18 and20, the same tension is present in theconnector portion48 andleg portions50 and52 of thesuture24.
• When theretainer54 has been moved downward into engagement with theouter surface300 of thebody tissue12 and the desired tension is present in theconnector portion48 andleg portions50 and52 of thesuture24, the crimp is plastically deformed to grip the leg portions of the suture. Plastic deformation of the suture retainer results in cold flowing of the material of the suture retainer. If desired, energy, such as heat or vibrational energy, may be transmitted to theretainer54 to facilitate plastic deformation of the material of the retainer under the influence of force applied against opposite sides of the retainer.
• Theretainer54 may be plastically deformed in the same manner as disclosed in U.S. patent application Ser. No. 09/685,795 filed Oct. 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. 09/685,795 is hereby incorporated herein in its entirety by this reference thereto.
• It is contemplated that thesuture retainer54 could be plastically deformed in other ways if desired. For example, ultrasonic vibratory energy may be transmitted to the material of thesuture retainer54 to effect heating of at least some of the material of the suture retainer. The ultrasonic vibratory energy may be applied while thesuture54 is being tensioned with a predetermined force and while a predetermined force is being transmitted from theconnector portion48 andleg portions50 and52 of thesuture24 to thebody tissue12. It is contemplated that thesuture retainer54 may be deformed by the use of ultrasonic vibratory energy in the manner 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 is hereby incorporated herein in its entirety by this reference thereto.
• In the embodiment of the invention illustrated inFIG. 9, theconnector portion48 andleg portions50 and52 of thesuture24 are pressed against thebody tissue12 by tension in the suture. If desired, a protective member, such as a pledget, may be positioned between thesuture24 and thebody tissue12. The protective member may be provided with openings through which thesuture24 extends into thebody tissue12. During tensioning of thesuture24, theretainer54 may be moved into engagement with the protective member. The protective member may have the same construction as any of the protective members disclosed in U.S. Pat. No. 4,823,794.
• It is believed that it may be desired to tension thesuture24 with a predetermined tension. It is also believed that it will be desired to transmit a predetermined force from theretainer54 to thebody tissue12 during tensioning of thesuture24. This may be accomplished by utilizing the apparatus which is illustrated schematically inFIG. 10.
• The apparatus includes ofFIG. 10 theforce application assembly60 which applies an upwardly (as viewed inFIG. 10) directedforce62 to theleg portions50 and52 of thesuture24. Contemporaneously with the application of thepredetermined tension force62 to theleg portions50 and52 of thesuture24, theforce application member66 presses thesuture retainer54 downward toward thebody tissue12 with a predetermined force indicated by thearrows70 and72 inFIG. 10. While thepredetermined tension force62 is applied to thesuture24 and thepredetermined forces70 and72 are applied to theretainer54 by theforce application member66, the retainer is plastically deformed under the influence offorces80 and82 applied against opposite sides of the retainer by theforce application members76 and78.
• Although theleg portions50 and52 of thesuture24 could extend straight through thesuture retainer54, it is preferred to form a plurality of bends in theleg portions50 and52 of thesuture24. In the illustrated embodiment of thesuture retainer54, two bends are formed in theleg portion50 of thesuture24 as it is wrapped around thesuture retainer54. Similarly, two bends are formed in theleg portion52 of thesuture24 as it is wrapped around thesuture retainer54.
• Thesuture retainer54 has a spherical configuration. Acylindrical passage340 extends through the center of thespherical suture retainer54. If desired, thesuture retainer54 could have a different configuration. For example, thesuture retainer54 could have an oval or elliptical configuration. Although thepassage340 has a linear central axis, the passage could have a nonlinear central axis. If desired, a plurality of passages having the same or different configurations could be provided in thesuture retainer54. Thesuture retainer54 could have any one of the constructions disclosed in the aforementioned U.S. patent application Ser. Nos. 09/685,795 and 09/524,397.
• After theleg portions50 and52 of thesuture24 have been inserted through thesuture retainer54, in the manner indicated schematically inFIG. 10, the suture retainer is moved along theleg sections50 and52 to tension the leg sections of thesuture24. The downward forces70 and72 are then applied against thesuture retainer54 by theforce application member66. This downward force results in the transmission of a predetermined force from the suture retainer to thebody tissue12 as theleg portions50 and52 of thesuture24 are tensioned with a predetermined tension force.
• While the predetermined tension is maintained in theleg portions50 and52 and theconnector portion48 of thesuture24 and while thesuture retainer54 is being pressed downward against thebody tissue12 with a predetermined force, theforce application members76 and78 are pressed against opposite sides of thesuture retainer54. The force applied against thesuture retainer member54 by theforce application members76 and78 plastically deforms the material of the suture retainer. If desired, ultrasonic vibratory energy could be applied to thesuture retainer54 by either or both of theforce application members76 and78.
• The force applied against the material of thesuture retainer54 results in a collapsing of thepassage340. In addition, cold flowing of the material of the suture retainer results in a flow of the material around theleg portions50 and52 of thesuture24.
• A transducer orload cell344 is provided to measure the amount of force, indicated by thearrow62, which is utilized to tension theleg portions50 and52 of the suture. While the predetermined tension force is applied to theleg portions50 and52 of the suture, theforce application members76 and78 are applying clamping forces against opposite sides of the suture retainer. Upon disengagement of theforce application members76 and78 from thesuture retainer54, the application of downward (as viewed inFIG. 10) force against thesuture retainer54 is also interrupted. The upward tensioning of theleg portions50 and52 of thesuture24 is also interrupted.
• Thesuture retainer54 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer54 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, the suture retainer could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. It is also contemplated that other biodegradable or bioerodible copolymers could be utilized if desired.
• Although it is preferred to form thesuture retainer54 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, thesuture retainer54 could be formed of an acetyl resin such as “Delrin” (trademark). Alternatively, thesuture retainer54 could be formed of a para-dimethylamino-benzenediazo sodium sulfonated, such as “Dexon” (trademark). If desired, thesuture retainer54 may be formed of the same material as thesuture24. However, thesuture retainer54 could be formed of a material which is different than the material of thesuture24. The manner in which thesuture retainer54 cooperates with thesuture24 is the same as is disclosed in the aforementioned U.S. patent application Ser. No. 09/685,795 filed Oct. 10, 2000 by Peter M. Bonutti et al. and entitled “Method and Apparatus for Securing a Suture.
• In the embodiment of the invention illustrated inFIGS. 1-10, thesuture24 is tightened with a desired tension by pulling on theleg portions50 and52 of the suture. The tension is maintained in thesuture24 by theretainer54. However, if desired, thesuture24 could be further tensioned by the application of heat to the suture. The application of heat to the polymeric material of thesuture24 causes the suture to shrink and increase the tension in the suture.
• Rather than using thesuture retainer54 to interconnect theleg portions50 and52, the leg portions could be bonded to each other. This could be accomplished by the application of heat and/or ultrasonic vibratory energy to the leg portions. The application of heat and/or ultrasonic vibratory energy to theleg portions50 and52 causes them to weld together 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”.
Embodiment of FIG.11
• In the embodiment ofFIG. 11, the anchors18aand20aare interconnected by asuture24awhich forms a continuous loop. By forming a continuous closed loop with thesuture24a, anchors18aand20aare interconnected when the anchors are moved into the body tissue12aand14a.
• In the illustrated embodiment of the invention, thesuture24ais formed into a continuous flexible ring by the application of ultrasonic energy to end portions of the suture. This may be accomplished in the manner disclosed in the aforementioned U.S. patent application Ser. No. 09/524,397 filed Mar. 13, 2000. The continuous loop of thesuture24amay be closed to form a flexible ring by knotting together opposite ends of a length of suture. Alternatively, opposite ends of a length of suture material may be spliced or bonded together to form a continuous closed loop. If desired, a connector member formed of polymeric material could be utilized to interconnect opposite ends of a length of suture material to form the continuous closed loop.
• The loop of thesuture24aforms a continuous flexible ring which extends throughpassages254aand256ain the suture anchor18a. The continuous flexible ring formed by thesuture24aextends through passages266aand268ain the anchor20a. The continuous loop or flexible ring formed by thesuture24ais freely movable in thepassages254aand256ain the anchor18aand in the passages266aand268ain the anchor20a. This enables the length of the connector portion48aand theconnector portion90 of thesuture24ato be varied as the suture anchors18aand20aare positioned relative to the body tissue12aand14a.
• The anchor18ahas the same construction as thesuture anchor18 ofFIGS. 1-10. Similarly, the anchor20ahas the same construction as thesuture anchor20 ofFIGS. 1-10. Although thesuture24aforms a continuous closed loop between the suture anchors18aand20a, thesuture24ais formed of the same material as thesuture24 ofFIGS. 1-10.
• It should be understood that the anchors18aand20amay be formed with any of many known configurations, including the configurations illustrated inFIGS. 18 and 19 herein. It should also be understood that the anchors18aand20amaybe formed of any of many known materials, including the anchor materials mentioned herein in association with the embodiment ofFIGS. 1-10. Thesuture24amay be formed with any known suture constructions mentioned herein in association with the embodiment ofFIGS. 1-10. Thesuture24amay be formed of many known materials, including the suture materials mentioned herein in association with the embodiment ofFIGS. 1-10.
• Theapparatus10aofFIG. 11 is associated with body tissue12aand14ahaving arcuate outer surfaces300aand304a. In the illustration ofFIG. 11, the body tissue14ais hard body tissue, that is bone, while the body tissue12ais soft body tissue, such as a tendon or ligament. However, it should be understood that both the body tissue12aand the body tissue14acould be soft body tissue.
• If the body tissue12aand14aare both soft body tissue, theapparatus10awould be utilized to connect the soft body tissue12awith the soft body tissue14ain a manner similar to the disclosure in U.S. Pat. No. 5,464,426 to Peter M. Bonutti for “Method of Closing Discontinuity in Tissue”. In the event that both of the body tissues12aand14aare soft body tissue, the anchors18aand20amay be embedded in the soft tissue forming the soft tissue14ain much the same manner as is illustrated inFIG. 11. However, it is also contemplated that the anchors18aand20acould be moved into and through the soft body tissue12aand into and through the soft body tissue14a.
• In the illustration ofFIG. 11, the body tissue14ais bone having a hard outer layer278awhich encloses a relatively softcancellous bone280a. The body tissue12aand14amay be many different tissues in a patient's body. For example, the tissue12acould be a meniscus and the tissue14acould be a bone in a patient's leg. Alternatively, the tissue12acould be a rotor (musculotendinous) cuff and the tissue14acould be a bone in an upper portion of a patient's body. The body tissues12aand14acould be vascular tissue.
• An inserter and pusher member corresponding to theinserter28 andpusher member30 ofFIG. 2 are utilized to move the anchor18ainto and through the body tissue12aand into the body tissue14a. As the anchor18amoves into the body tissue12a, a pointed leading end portion34aof the anchor18ainitiates the formation of an opening in an imperforate surface on the outer surface300aof the body tissue12a. As the anchor18amoves into and through the soft body tissue12a, the leading end portion34ais utilized to pierce the body tissue12a.
• As the anchor18amoves through the body tissue12a, the leading end portion34aof the anchor12amoves into engagement with the outer surface304aon the hard outer layer278aof the bone14a. The force applied against the anchor18aby the pusher member causes the leading end portion34aof the anchor18ato initiate the formation of an opening at an imperforate area on the outer surface304aof the hard outer layer278a. As the anchor18ais moved into the hard outer layer278a, the leading end portion34aof the anchor pierces the outer layer ahead of the pusher member. As the anchor18amoves through the outer layer278a, the leading end portion34aof the anchor initiates the formation of an opening in the softcancellous bone280a. As the anchor18ais pushed into the softcancellous bone280aby the pusher member, the leading end portion34aof the anchor18adeforms the soft cancellous bone.
• The anchor18amoves through the soft body tissue12aand the hard outer layer278aof the bone14ainto the softcancellous bone280aalong an insertion path having a straight longitudinalcentral axis350. However, the anchor18acould be moved along a nonlinear path if desired. As the suture anchor18amoves through the body tissue12ainto the body tissue14a, a longitudinalcentral axis260aof the anchor18ais coincident with the longitudinalcentral axis350 of the path along which the anchor moves into the body tissue.
• Once the anchor18ahas been moved to a desired depth in the body tissue14a, the pusher member30 (FIG. 4) may be moved from the extended condition back to the retracted condition ofFIG. 3. The inserter, corresponding to theinserter28 ofFIGS. 3 and 4, may then be withdrawn from the body tissue12a.
• Alternatively, the orientation of the anchor18amay be changed from an orientation in which the longitudinal central axis360aof the anchor18ais aligned with the longitudinalcentral axis350 of the path along which the anchor is inserted into the body tissue12aand14ato an orientation in which thecentral axis260aof the anchor extends transverse to the longitudinalcentral axis350 of the insertion path. It is believed that it may be desired to change the orientation of the anchor18arelative to the insertion path in order to increase the resistance of the anchor to tension forces transmitted through thesuture24ato the anchor18a.
• In order to move the anchor18afrom an orientation in which the longitudinalcentral axis260aof the anchor is aligned with the longitudinalcentral axis350 of the insertion path to the orientation illustrated inFIG. 11, thesuture24ais tensioned. The tension forces initiate a toggling or pivoting action about the end portion of the pusher member which engages the anchor18a. This toggling action occurs in the same manner as was previously discussed in conjunction with the embodiment of the invention illustrated inFIGS. 4 and 5.
• Once the anchor18ahas been pivoted to the desired orientation relative to the body tissue14a, the pusher member is telescopically withdrawn into the inserter and the inserter is removed from thesoft body tissue12. The viscoelastic nature of the body tissues12aand14acause the passages formed by the anchor18ato constrict as the pusher member and inserter are withdrawn from the body tissues12aand14a.
• Once the anchor18ahas been positioned in the body tissue14a, in the manner illustrated schematically in solid lines inFIG. 11, the anchor20ais positioned in the body tissue14a. To position the anchor20ain the body tissue14a, the anchor is moved from the position illustrated in solid lines inFIG. 11 along an insertion path having acentral axis354. The insertion path along which the anchor20ais moved into the body tissue12aand14amay be either linear or nonlinear.
• An inserter and pusher member, corresponding to theinserter38 andpusher member40 ofFIGS. 6 and 7, are utilized to move the suture anchor20athrough the body tissue12aand into the body tissue14ain the same manner as previously described in conjunction with the embodiment of the invention illustrated inFIGS. 1-10. As the anchor20ais moved along the insertion path by the pusher member, the longitudinalcentral axis320aof the anchor is aligned with the longitudinalcentral axis354 of the insertion path.
• In the embodiment of the invention illustrated inFIG. 11, the anchors18aand20aare formed with pointed leading end portions34aand44a. The pointed end portions34aand44aenable the anchors18aand20ato form their own passages through the body tissues12aand14a. However, it is contemplated that the anchors12aand14acould be provided with blunt leading end portions. If this was done, passages for the anchors12aand14acould be formed in the body tissues by a suitable tool, such as a drill.
• As the anchor20amoves along the insertion path, thesuture24ais tensioned by movement of the anchor20a. Thus, as the anchor20amoves along the insertion path, theconnector sections48aand90 of the suture are tensioned and pressed against the outer surface300aof the body tissue12a. Theflexible suture24aconforms to any irregularities in the outer surface300aof the body tissue12aand is effective to firmly press the body tissue12aagainst the outer surface304aon the bone14a.
• As thesuture24amoves from the initial loose condition, indicated schematically in solid lines inFIG. 11, to the tensioned condition, indicated schematically in dashed lines inFIG. 11, the suture may move in the passages266aand268ain the anchor20ato enable the length of theconnector sections48aand90 of thesuture24ato be adjusted. This shifting movement of thesuture24arelative to the anchor20aresults in the same tension forces being present in bothconnector sections48aand90 of thesuture24a.
• As the anchor20ais moved along theinsertion path354, the tension forces in both connector sections48aand90aof the suture increase. When a desired tension is present in both of theconnector sections48aand90 of thesuture24a, movement of the suture anchor20aalong the insertion path is interrupted. Thus, as the anchor20ais moved into thecancellous bone280a, thesuture24ais pulled taut between the two anchors18aand20a. As the anchor20amoves along the insertion path, the tension in thesuture24aincreases and the force which is transmitted from the suture to the body tissue12aincreases. The increase in force transmitted to the body tissue12afirmly presses the body tissue against the bone14a.
• In order to enhance the resistance of the anchor20ato pull out forces applied to the anchor by thesuture24a, the anchor may be pivoted from an orientation in which the longitudinalcentral axis320aof the anchor is aligned with thecentral axis354 of the insertion path to an orientation in which the central axis of the anchor20aextends transverse to the central axis of the insertion path. This toggling or pivotal movement of the anchor20ais initiated by tension in thesuture24aas the anchor is moved along the insertion path by the pusher member. A bevel surface on the leading end portion of the pusher member promotes pivoting or toggling of the anchor relative to the pusher member.
• During movement of the anchor20aalong theinsertion path354 by the pusher member, thesuture24ais pulled against the anchor18awhich was initially inserted into the body tissue14a. As thesuture24ais pulled against the anchor18aand the anchor20amoves into the body tissue14a, a toggling action is automatically initiated by the resulting tension in thesuture24a. This toggling action results in pivotal movement of the anchor20aabout a leading end portion of the pusher member. As the anchor20apivots relative to the leading end portion of the pusher member, the anchor moves from an orientation in which the longitudinalcentral axis320aof the anchor is coincident with the longitudinalcentral axis354 of the insertion path to the orientation illustrated schematically in dashed lines inFIG. 11. As the anchor20amoves toward the position illustrated in dashed lines inFIG. 11, thecentral axis320aof the anchor moves out of alignment with thecentral axis354 of the insertion path.
• In the embodiment of the invention illustrated inFIG. 11, thecentral axes350 and354 of the insertion paths for the anchors18aand20aare disposed in a plane which extends through a center of curvature of the outer surface300aof the body tissue12aand a center of curvature of the outer surface304aof the body tissue14a. Thecentral axes350 and354 of the insertion paths along which the anchors18aand20aare moved into the body tissue12aand14aintersect at the center of curvature of the outer surface300aof the body tissue12aand the outer surface304aof the body tissue14a.
• Although thecentral axes350 and354 of the insertion paths along which the anchors18aand20aare moved into the body tissue12aand14aare disposed in a single plane, it is contemplated that thecentral axes350 and354 of the insertion paths could be offset relative to each other. Thus, thecentral axis354 could be offset from thecentral axis350 in a direction extending into the sheet of the drawing ofFIG. 11. Although thecentral axes350 and354 of the insertion paths intersect at the center of curvature of the outer surface300aof the body tissue12aand the outer surface304aof the body tissue14a, the angle of theaxes350 and354 relative to the outer surfaces300aand304aof the body tissue12aand14acould be such that theaxes350 and354 do not extend through the center of curvature of the surfaces300aand304aof the body tissue12aand14a.
• In the embodiment of the invention illustrated schematically inFIG. 11, thecentral axes350 and354 of the insertion paths of the anchors18aand20aextend generally perpendicular to a tangent to the arcuate outer surface300aof the body tissue12a. It is contemplated that thecentral axes350 and354 of the insertion paths along which the anchors18aand20aare moved into the body tissue12aand14acould be skewed at an angle of between 30° and 90° relative to a tangent to the outer surface300aof the body tissue12a.
• In the embodiment of the invention illustrated inFIG. 11, the anchor18ais disposed deeper in the body tissue14athan is the anchor20a. Thus, the distance which the anchor18awas moved along its insertion path from the outer surface304aof the body tissue14awas greater than the distance which the anchor20awas moved along its insertion path from the outer surface of the body tissue14a. It is contemplated that the anchors18aand20acould be moved to substantially the same depth in the body tissue14aif desired. It is also contemplated that the anchor20acould be moved deeper into the body tissue14athan the anchor18a.
• The anchors18aand20ahave been illustrated inFIG. 11 with their longitudinalcentral axes260aand320aextending transverse to each other. It is contemplated that the anchors18aand20acould be positioned in the body tissue14awith their longitudinalcentral axes260aand320adisposed in a parallel relationship. InFIG. 11, the outer side surfaces300aand304aof the body tissue12aand14ahave been illustrated as having an arcuate configuration. However, it is contemplated that the body tissues12aand14acould have outer surfaces which have an irregular arcuate configuration, or an irregular generally flat configuration, or a combination of irregular, arcuate and flat configurations. For example, the surface304acould be disposed on the end of a bone and thecentral axes350 and354 of the insertion paths for the anchors18aand20acould be offset so as to extend through the sides of the bone.
• It is contemplated that theapparatus10awill be utilized in many different environments to secure body tissue. Thus, theapparatus10amay be used to connect a meniscus with a bone in a knee joint of a patient. It is also contemplated that theapparatus10amay be utilized to connect a rotator cuff with the bone in a shoulder of a patient. Theapparatus10amay be used to interconnect sections of blood vessels. Theapparatus10amay be used to secure mucosa. It should be understood that these are only specific examples of many different locations in a patient's body in which theapparatus10amay be utilized to secure body tissues.
• Although theapparatus10ahas been described inFIG. 11 in conjunction with the connection of soft body tissue12awith bone14a, it is contemplated that theapparatus10amay be utilized to connect one portion of soft body tissue in a patient's body with another portion of the soft body tissue in a patient's body. For example, layers of soft tissue may be positioned in a side-by-side relationship and interconnected using theapparatus10a. When relatively thin layers of soft tissue are placed in apposition, the anchors18aand20amay be moved through the both layers of tissue and disposed adjacent to a side of the tissue in a manner similar to that disclosed in the aforementioned U.S. Pat. No. 5,464,426. Alternatively, the anchors18aand20amay be moved through a relatively thin layer of soft body tissue into a relatively thick mass of soft body tissue. When this is done, it is believed that it may be desired to have the anchors embedded in the soft body tissue in the same manner as is illustrated schematically inFIG. 11.
• In the foregoing description, the anchor18ahas been inserted into the body tissue14abefore the anchor20ais inserted into the body tissue14a. It should be understood that both anchors18aand20acould be inserted into the body tissue at the same time. Thus, a first pusher member and inserter, corresponding to thepusher member30 andinserter28 ofFIG. 2 could be used to move the anchor18aalong a first insertion path into the body tissue14aat the same time that a second inserter and pusher member, corresponding to the inserter andpusher member38 and40 ofFIG. 6, are utilized to move the anchor20ainto the body tissue14a. As this occurs, the rate of insertion of the anchors18aand20acould be coordinated so that they would be at the same depth in the body tissue14aat the same time.
• As the anchors18aand20aare moved together into the body tissue14a, thesuture24ais pulled into the body tissue14aby both of the anchors. This results in thesuture24abeing tensioned between the two anchors as both of the anchors move relative to the body tissue14a. Since both anchors18aand20aare being moved at the same time relative to the body tissue14a, there will be relative movement between thesuture24aand both of the anchors to obtain the required length of suture in theconnector portion48aand90. Adjusting of the lengths of theconnector portions48aand90 of thesuture24ais accommodated by the fact that the suture can move in thepassages254aand256ain the anchor18aand in the passages266aand268ain the anchor20a.
• If desired, both anchors could be left in the body tissue14awith their longitudinal central axes coincident with the longitudinal central axes of their paths of insertion. Thus, the anchor18acould be left in the body tissue14awith itscentral axis260acoincident with thecentral axis350 of the insertion path of the anchor18a. Similarly, the anchor20acould be left in the body tissue14awith itscentral axis320acoincident with thecentral axis354 of the insertion path of the anchor20ainto the body tissue14a. If it is desired to leave the anchors in the body tissue14awith theircentral axes260aand320acoincident with thecentral axes350 and354 of their insertion paths, the beveled surfaces, corresponding to thesurface310 ofFIG. 4 and thesurface324 ofFIG. 7 on the pusher members could be omitted.
• Since thecentral axes350 and354 of the insertion paths of the anchors18aand20ainto the body tissue14aextend transverse to each other, the anchors18aand20amove toward each other as they move along their insertion paths. Thus, as the anchor18ais moved along the longitudinalcentral axis350 of its insertion path into the body tissue14a, the anchor18amoves toward theaxis354 of the insertion path for the anchor20a. Similarly, as the anchor20amoves along thecentral axis354 of its insertion path, the anchor20amoves toward the insertion path for the anchor18a. By moving the anchors18aand20atoward each other along their insertion paths, thesuture24agrips the body tissues12aand14awith a clinching action. This clinching action firmly presses the body tissue12aagainst the body tissue14a. If the anchors18aand20aare toggled or pivoted to the orientation indicated in solid lines for the anchor18aand dashed lines for the anchor20ainFIG. 11, the clinching action of thesuture24aagainst the body tissues12aand14ais increased. This clinching action tends to maximize the tension forces which can be transmitted through thesuture24awithout pulling the anchors18aand20aout of the body tissue14a.
• The anchors18aand20aare supported in thecancellous bone280ain a spaced apart relationship with the hard outer layer278aof the bone14a. Thus, the tension forces transmitted through thesuture24aare transmitted from the anchors18aand20ato thecancellous bone280a.
• In the embodiment of the invention illustrated inFIG. 8, thesuture24aextends through both the body tissue12aand the body tissue14a. Tension in thesuture24apresses the body tissue12aagainst the body tissue14a. However, thesuture24acould extend across the body tissue12aand the anchors18aand20amoved into the body tissue14awithout passing through the body tissue. If this was done, thesuture24awould extend into the body tissue14aat locations offset from opposite edges of the body tissue12a. Alternatively, the body tissue12acould be spaced from the body tissue14aand an extension could extend from the continuous loop formed by thesuture24ato the body tissue12a.
• It is contemplated that it may be desired to increase the tension in thesuture24aafter the anchors18aand20ahave been positioned relative to the body tissues12aand14a. This may be done by contracting thesuture24aunder the influence of heat. If thesuture24ais to be heated, it may be desired to position a protective member between the suture and the tissue12a. The protective member may have any desired construction, including any of the constructions disclosed in U.S. Pat. No. 4,823,794.
Embodiment of FIG.12
• In the embodiment of the invention illustrated inFIG. 11, aforce application assembly60 is effective to apply tension force to thesuture24 and to determine when a predetermined tension force is present in thesuture24. In the embodiment of the invention illustrated inFIG. 12, a tension measuring device106 is associated with theinserter38bandpushrod40bfor asuture anchor20b. Thesuture anchor20bis connected with a second suture anchor (not shown) corresponding to the suture anchor18ainFIG. 11, by asuture24b. Thesuture24bis formed as a continuous closed loop which extends between thesuture anchor20band another suture anchor, corresponding to the suture anchor18aofFIG. 11.
• The suture anchor corresponding to the suture anchor18aofFIG. 11 is moved into the body tissue14b, to a position corresponding to the position illustrated in solid lines inFIG. 11. Thesuture anchor20bis then moved through thebody tissue12band into the body tissue14bwith aninserter38bandpusher member40b(FIG. 12). Thesuture anchor20bis moved through the hardouter layer278bof the bone forming the body tissue14binto the relatively softcancellous bone280b. Theanchor20bis then pivoted or toggled to a position corresponding to the position illustrated in dashed lines inFIG. 11 for the suture anchor20a.
• As theanchor20bis moved into the body tissue14b, tension in theconnector portions48band90bof thesuture24bis measured by the force measuring device106. When a predetermined tension is present in theconnector portion48band90bof thesuture24b, the output from the force measuring device106 causes the pushermember drive assembly114 to interrupt movement of the pusher member into the body tissue14b. When this occurs, a longitudinalcentral axis320bof theanchor20bis coincident with a longitudinalcentral axis354bof the path along which theanchor20bis moved into thebody tissues12band14b. Theconnector portions48band90bof thesuture24bextend through theslot316bin theinserter38b.
• In the illustrated embodiment of the invention, theforce transmitting member100 of the tension measuring device96 is disposed in theslot316bin the side wall of thetubular inserter38b. Theconnector portions48band90bof thesuture24bextend across theend portion102 of theforce transmitting member100. Although theforce transmitting member100 has been illustrated inFIG. 12 as being disposed in theslot316b, it is contemplated that theforce transmitting member100 could be disposed outside of the slot adjacent to an outer side surface of theinserter38b.
• As the pushermember drive assembly114 is operated to move thepusher member40baxially relative to thestationary inserter38b, theanchor20bis moved from the position illustrated inFIG. 12 into the body tissue14b. As thesuture anchor20bmoves into the body tissue14b, thesuture24bis pulled into the body tissue along with the suture anchor. As this occurs, a tension force is established in theconnector portions48band90bof thesuture24b.
• The tension force in theconnector portions48band90bof thesuture24bresults in the application of a downward (as viewed inFIG. 12) force against theend portion102 of theforce transmitting member100 by theconnector portions48band90bof thesuture24b. This force is transmitted through theforce transmitting member100 to theforce measuring device112. Theforce measuring device112 includes a piezoelectric cell. When theforce measuring device112 detects that a predetermined tension force is present in theconnector portions48band90bof thesuture24b, an output signal from the force measuring device is transmitted to a control apparatus, that is, a microprocessor, which interrupts operation of thepusher drive assembly114.
• At the time when operation of thepusher drive assembly114 is interrupted, the tension force in theconnector portions48band90bof thesuture24bhave initiated toggling or pivoting movement of thesuture anchor20bin thecancellous bone280b. This toggling or pivotal action moves the central axis of theanchor20bfrom an orientation in which it is aligned with thecentral axis354bof the path along which thesuture anchor20bis moved into the body tissue14bto an orientation in which thecentral axis320bof thesuture anchor20bextends transverse to thecentral axis354bof the path along which the suture anchor moves into the body tissue14b. When the operation of thepusher drive assembly114 is interrupted, theanchor20bwill have pivoted to a position corresponding to the position illustrated in dashed lines inFIG. 11 for the anchor20a.
• Although it is believed that it will be preferred to utilize a tension measuring device, corresponding to the tension measuring device96, which is connected with theinserter38b, it is contemplated that the tension measuring device could be separate from theinserter38b. For example, the tension measuring device96 could engage theconnector portions48band90bof thesuture24bat a location which is approximately midway between theanchor20band the another anchor connected with thesuture24band corresponding to the anchor18aofFIG. 11. If desired, a tension measuring device could be substituted for the force application assembly ofFIG. 10.
• It is contemplated that a protective member, such as a pledget, could be provided between thesuture24band thebody tissue12b. The protective member provided between thesuture24band thebody tissue12bmay be formed of a biodegradable or bioerodible polymer or copolymer if desired. The protective member may have any one of the constructions disclosed in U.S. Pat. No. 4,823,794.
• It is contemplated that a robotic apparatus may be utilized to position suture anchors corresponding to the suture anchors18 and20 ofFIGS. 1-10, the suture anchors18aand20aofFIG. 11, and thesuture anchor20bofFIG. 12 relative to body tissue. The inserters28 (FIGS. 2-4),38 (FIGS. 6 and 7), and38b(FIG. 12) along with the pusher members30 (FIGS. 2-4),40 (FIGS. 6 and 7), and40b(FIG.12) are connected with articulate arms of the robotic apparatus. Devices for effecting relative movement between the inserter members and the pusher members, similar to the pushermember drive assembly114 andinserter drive assembly110 ofFIG. 12, are connected with the articulate arms of the robotic apparatus.
• Operation of the pushermember drive assembly114 and theinserter drive assembly110 is controlled by one or more computers in the robotic apparatus. The tension measuring device96 is also be associated with an articulate arm of the robotic apparatus. The tension measuring device96 is mounted on the articulate arm of the robotic apparatus in association with a slot, corresponding to theslot316bofFIG. 12, in theinserter38b. Alternatively, the tension measuring device96 could be mounted on the articulate arm of the robotic apparatus in a spaced apart relationship with the inserter.
• It is contemplated that the robotic apparatus will be utilized to position anchors, corresponding to theanchors18 and20 ofFIGS. 1-10, the anchors18aand20aofFIG. 11, and the anchor18bofFIG. 12 relative to body tissue at many different locations in a patient's body. The body tissue may be hard body tissue, soft body tissue, or a combination of hard and soft body tissue. If desired, a drill or similar tool could be associated with an articulate arm of the robotic apparatus to assist in the formation of an opening in the body tissue. The drill would form an opening extending through the hardouter layer278binto thecancellous bone280b. The opening formed by the drill could have a cross sectional area which is smaller than the cross sectional area of theanchor20b.
• The robotic apparatus may have any one of many different constructions. It is contemplated that the robotic apparatus may have a construction similar to the construction illustrated in U.S. Pat. Nos. 6,063,095 and 6,102,850. The disclosures in the aforementioned U.S. Pat. Nos. 6,063,095 and 6,102,850 are hereby incorporated herein in their entirety by this reference thereto.
Embodiment of FIG.13
• In the embodiments of the invention illustrated inFIGS. 1-12, the suture anchors18,20,18a,20a, and20bare either positioned manually relative to body tissue or positioned relative to the body tissue by a robotic apparatus. Aguide assembly120 which may be utilized with either the manual or robotic insertion of anchors into body tissue is illustrated inFIG. 13. Theguide assembly120 is utilized to be certain that the insertion paths along which the anchors are moved into the body tissue have a desired angular orientation relative to each other and to the body tissue.
• Theguide assembly120 includes the cylindrical guides126 and128 which are supported in a preselected angular relationship relative to each other by thebase124. Theguide128 may be moved toward and away from theguide126, in the manner indicated by thearrow136 inFIG. 13, to vary the spacing between the guides.
• In the embodiment of the invention illustrated inFIG. 13, theguides126 and128 have a construction which corresponds to the tubular construction of theinserters28 and38 ofFIGS. 2-8. Thus, theguide126 is provided with aslot292cthrough which a portion of thesuture24cextends away from theanchor18c. Similarly, theguide128 is provided with a slot316cthrough which a portion of thesuture24cextends away from theanchor20c.
• Thepusher member132 has the same cylindrical construction as thepusher member30 ofFIGS. 2-4. However, thepusher member132 is provided withindicia360 which cooperates with theguide126 to indicate the depth to which theanchor18chas moved intocancellous bone280c. Thus, as the pusher member is moved downward and toward the right (as viewed inFIG. 13), theindicia360 moves to a location adjacent to acircular end surface364 on theguide126.
• When thepusher member132 has moved into the body tissue14cto a desired depth, a predetermined mark on theindicia360 will have moved into alignment with theend surface364 on theguide126. This enables a surgeon to visually determine the depth to which theanchor18chas moved into the body tissue. Once theanchor18chas moved into the desired depth in the body tissue, movement of thepusher member132 relative to theguide126 is interrupted. Theanchor18cis then pivoted under the influence of tension in thesuture24c. During this pivotal movement of theanchor18c, thepusher member132 may be moved further into the body tissue14cthrough a relatively short predetermined distance to promote the pivoting or toggling action of the anchor.
• Thepusher member132 may be utilized to move theanchor20cinto the body tissue14c. If this is done, the depth to which theanchor20cis moved into the body tissue14cwill be clearly indicated by movement of theindicia360 on thepusher member132 relative to acircular end surface368 on theguide128.
• It is contemplated that a pair of pusher members, having the same construction as thepusher member132, could be provided to move theanchors18cand20crelative to theguides126 and128. If this was done, bothanchors18cand20ccould be simultaneously inserted into the body tissue14c.
• When a robotic apparatus is utilized to move theanchors18cand20cinto the body tissue14c, articulate arms of the robotic apparatus could be provided with fiber optic systems. These fiber optic systems would view the pusher members and endsurfaces364 and366 on theguides126 and128 and provide an indication to a suitable control apparatus when theindicia360 is in a desired position relative to the guides. Alternatively, the articulated arms of the robotic apparatus could be provided with drives, for examples, screw and nut drives, which would indicate the extent of operation of the drives and thereby the extent of movement of the pusher members, corresponding to thepusher member132, relative to theguides126 and128 and the depth of insertion of theanchors18cand20cinto the body tissue14c.
• In the embodiment of the invention illustrated inFIG. 13, theguides126 and128 perform the same functions as theinserters28 and38 ofFIGS. 2-8. However, it is contemplated that the guides could be constructed so as to receive inserters corresponding to theinserters28 and38 and to position the inserters relative to the body tissue.
• When theguide assembly120 is utilized in association with a robotic apparatus, it is contemplated that theguide126, which is fixedly connected with thebase124 of theguide assembly120, could be connected with one articulate arm of the robotic apparatus. This would result in thebase124 of the guide assembly being positioned relative to thebody tissue12cand14cin a patient along with theguide126. The position of theretainer140 along thebase124 would be adjusted to position theguide128 in a desired relationship with theguide126. It is contemplated that theretainer140 will be held against movement relative to the base by a suitable set screw which extends through a portion of the retainer into engagement with the base. When the set screw is loosened, theretainer140 and guide128 may be moved along thebase124, in the manner indicated schematically by thearrow136 inFIG. 13. When the set screw is tightened, theretainer140 and guide128 are held against movement relative to thebase124.
• When theguide126 andbase124 are connected with one articulate arm of a robotic apparatus, one or more pusher members, corresponding to thepusher member132, can be moved relative to theguides126 and128 by one or more additional articulate arms of the robotic apparatus. For example, if theanchors18cand20care to be sequentially moved into the body tissue14c, a single robotic arm could be provided to move thepusher member132 relative to theguide126 to move theanchor18cinto the body tissue. The same articulate arm could be utilized to move thesame pusher member132 relative to theguide128 to move theanchor20cinto the body tissue14c. Alternatively, a pair of pusher members, both of which have the construction of thepusher member132, could be utilized to simultaneously move both of theanchors18cand20cinto the body tissue14c. If this is done, one of the pusher members could be associated with one articulate arm of the robotic apparatus and the second pusher member could be associated with another articulate arm of the robotic apparatus.
• In the embodiment of the invention illustrated inFIG. 13, thesuture24cforms a continuous loop which extends between theanchors18cand20cin the same manner as is illustrated schematically inFIG. 11. If theanchor18cis moved into the body tissue14cbefore theanchor20cis moved into the body tissue, thesuture24cwould be tensioned between the twoanchors18cand20cas theanchor20cmoves into the body tissue. As thesuture24cis tightened, it applies force against thebody tissue12cto firmly press thebody tissue12cagainst the body tissue14c. If both of theanchors18cand20care simultaneously moved into the body tissue14c, movement of both anchors relative to the body tissue14cwill be effective to tension the suture.
• The tension measuring device96 ofFIG. 12 may be associated with either theguide126 or theguide128. If desired, one tension measuring device96 could be associated with theguide126 and a second tension measuring device could be associated with theguide128. Alternatively, a tension measuring device96 could be mounted on the base124 in a spaced apart relationship with theguides126 and128.
• It is contemplated that, rather than being a continuous loop, thesuture24ccould have the same construction as thesuture24 ofFIGS. 1-10. If this was done, a connector portion of the suture would extend between the twoanchors18cand20c. Leg portions of the suture would be interconnected with a suitable retainer or crimp, corresponding to theretainer54 ofFIGS. 9 and 10.
• Of course, if thesuture24chas the same construction as thesuture24 ofFIGS. 1-10, only the connector portion of the suture extending between the twoanchors18cand20cwould be tensioned as the anchors move into the body tissue14c. The two leg portions of the suture would be tensioned after theanchors18cand20chad moved into the body tissue14c. This could be accomplished manually or by the use of a force application assembly, corresponding to theforce application assembly60 ofFIG. 10. In this situation, a force application member, corresponding to theforce application member66 ofFIG. 10 may be utilized to press the retainer against the body tissue. While thesuture24cis being tensioned with a predetermined force and while the retainer is being pressed against the body tissue with a predetermined force, force application members, corresponding to forceapplication members76 and78 ofFIG. 10, would be utilized to effect deformation of the retainer.
Embodiment of FIGS.14 and15
• In the embodiments of the invention illustrated inFIGS. 1-13, leading end portions of the anchors have been utilized to initiate the formation of openings in the soft body tissue and the hard body tissue. It is contemplated that it may be desired to initiate the formation of openings in either the soft body tissue or the hard body tissue or both with a tool other than the anchors. In the embodiment of the invention illustrated inFIGS. 14 and 15, thinelongated members146 and160 are utilized to initiate the formation of the openings in bothsoft body tissue12dandhard body tissue14d.
• In addition to initiating formation of openings in thesoft body tissue12dandhard body tissue14d, the thinelongated members146 and160 function as guides along which theanchors18dand20dare moved into thebody tissues12dand14d. Thus, the thinelongated members146 and160 are first positioned at desired angles relative to each other and to thebody tissues12dand14d. The thinelongated members146 and160 are forced axially through thesoft body tissue12dinto thehard body tissue14d.
• Movement of the thinelongated members146 and160 into thehard body tissue14dis interrupted after the thin elongated members have moved to a depth which is greater than the depth to which it is intended to subsequently move theanchors18dand20dinto thehard body tissue14d. The thinelongated members146 and160 are moved deeper into thehard body tissue14dthan the intended depth of theanchors18dand20din thehard body tissue14dto enable the thin elongated members to guide movement of the anchors to their intended depth in the hard body tissue. The thinelongated members146 and160 may be simultaneously or sequentially moved through thebody tissue12dinto thebody tissue14d.
• Anchors18dand20dare moved along the stationary thinelongated members146 and160 (FIG. 15) into thebody tissue12dand14d. Theanchors18dand20dhave the same construction as theanchors18 and20 ofFIGS. 1-10. However, theanchors18dand20dhave axially extendingcylindrical passages152 and166 which receive the thinelongated members146 and160. Like theanchors18 and20 ofFIGS. 1-10, theanchors18dand20d(FIGS. 14 and 15) are formed of bone. However, theanchors18dand20dcould be formed of any of the materials previously mentioned in association with theanchors18 and20 ofFIGS. 1-10.
• When theanchor18d(FIG. 14) is to be moved along the thinelongated member146, theanchor18dis telescopically positioned on the stationary thinelongated member146. Theanchor18dis moved along the thinelongated member146 until theleading end portion34dof theanchor18dengages thesoft body tissue12d. At this time, the cylindrical thinelongated member146 extends through thecylindrical passage152 in theanchor18dand positions theanchor18drelative to thebody tissues12dand14d.
• Thecylindrical pusher member30dis then telescopically positioned on the stationary thin elongated member146 (FIG. 14). Thepusher member30dis moved along the thinelongated member146 until a circularleading end surface370 on thepusher member30dengages a trailing end of theanchor18d. At this time the cylindrical thinelongated member146 extends through both thecylindrical passage152 in theanchor18dand thecylindrical passage156 in thepusher member30d. This enables the stationary thinelongated member146 to position both theanchor18dandpusher member30drelative to thebody tissues12dand14d.
• After thepusher member30dandanchor18dhave been positioned on the thinelongated member146, thecylindrical inserter28dis positioned in a telescopic relationship with theanchor18dandpusher member30d. An axial force is applied to theinserter28dto slide the inserter along thestationary pusher member30dandanchor18dthrough thebody tissue12dinto engagement with thebody tissue14d, as shown inFIG. 14. At this time, the leading end portion of thepusher member30dandanchor18dare fully enclosed by theinserter28d. Theleading end portion34dof theanchor18dis disposed in engagement with thesurface300don thebody tissue12d.
• Movement of theinserter28dthrough thebody tissue12dinto engagement with thebody tissue14dis guided by thestationary pusher member30dandstationary anchor18d. Thepusher member30dandanchor18dare held in the desired orientation relative to the body tissue by the thinelongated member146. When theinserter28dis moved to the position shown inFIG. 14 in engagement with thebody tissue14d, theleading end portion34dof theanchor18dis in engagement with thesurface300dof thebody tissue12dand is fully enclosed by theinserter28d.
• An axial force is then applied to thepusher member30dto move theanchor18dthrough thebody tissue12dinto thebody tissue14d. During this movement of thepusher member30dandanchor18d, both theinserter28dand thinelongated member146 are stationary relative to thebody tissues12dand14d. When theanchor18dhas moved to the desired depth in thebody tissue14d, movement of thepusher member30dand anchor along the thinelongated member146 is interrupted.
• When theanchor18dhas been moved to the desired depth in thebody tissue14d, the anchor is in the position illustrated inFIG. 14 relative to the thinelongated member146 and theinserter28d. Indicia corresponding to the indicia360 (FIG. 13) is provided on thepusher member30d(FIG. 14) to indicate when theanchor18dhas moved to the desired position relative to thebody tissues12dand14d.
• Theanchor20d(FIG. 15) is positioned relative to thebody tissues12dand14din the same manner as previously explained in conjunction with theanchor18d. The thinelongated member160 is utilized to guide movement of theanchor20dand pusher member relative to thebody tissue12din the same manner as previously explained in conjunction with theanchor18d. The thinelongated member160 may be positioned relative to thebody tissue12dand14d(FIG. 15) simultaneously with the thinelongated member146 or after the thinelongated member146 has been positioned relative to thebody tissue12dand14d.
• Theanchor20dandpusher member40dare positioned in a telescopic relationship with the thinelongated member160. Theanchor20dis moved along the stationary thinelongated member160 into engagement with thesurface300don thebody tissue12d. Thepusher member40dis moved along the stationary thinelongated member160 to a position in which a circularleading end surface374 on thepusher member40dengages the trailing end of theanchor20d.
• Theinserter38dis then positioned in a telescopic relationship with thestationary pusher member40d,anchor20d, andelongated member160. Thecylindrical inserter38dis moved through thebody tissue12dinto engagement with thesurface304dof thebody tissue14d. This movement of theinserter38dis guided by thestationary pusher member40dandanchor20d.
• Once theinserter38dhas been moved to the position illustrated inFIG. 15 relative to thebody tissue12dand14d, thepusher member40dis moved axially along the stationary thinelongated member160. Force transmitted from thepusher member38dto theanchor20dmoves the anchor through thebody tissue12d. Further movement of thepusher member40dalong the stationary thinelongated member160 moves theanchor20dto the position illustrated inFIG. 15. Indicia on thepusher member40dcooperates with theinserter38dto indicate when theanchor20dhas moved to a desired depth in thebody tissue14d.
Embodiment of FIGS.14 and15Alternate Method
• The foregoing description has related to a process in which the thinelongated members146 and160 are moved into thebody tissue14dprior to movement of theanchors18dand20dinto thebody tissue12dand14d. An alternative method for moving theanchors18dand20dinto thebody tissue14dinvolves movement of the thinelongated members146 and160 together with the anchors into thebody tissues12dand14d.
• When theanchor18dis to be moved through thebody tissue12dinto thebody tissue14din accordance with the aforementioned alternative method, the thinelongated member146 is inserted through thepassage156 in thepusher member30d(FIG. 14). The thinelongated member146 is moved to a position in which thepointed end portion148 of the thin elongated member extends past acircular end surface370 on thepusher member30d. The portion of the thinelongated member146 extending past theend surface370 on thepusher member30dis then telescopically inserted through thepassage152 in theanchor18d.
• At this time during the alternative method, thepointed end portion148 on the thinelongated member146 extends a short distance past a conicalleading end portion34dof theanchor18d. This results in thepointed end portion148 on the thin elongated member forming a point for theleading end portion34dof theanchor18dat the location where thepassage152 ends at theleading end portion34dof theanchor18d.
• Thepusher member30d, thinelongated member146, andanchor18dare then telescopically inserted into theinserter28d. Theanchor18dandpusher member30dare then moved to a position in which the anchor extends from theinserter28d. Thus, the anchor is moved to a position corresponding to the position of theanchor18 inFIG. 2. The portion of thesuture24dadjacent to theanchor18dis tensioned to press a trailing end portion32dof the anchor firmly against theend surface370 on thepusher member30d.
• At this time during the alternative method, thepointed end portion148 of the thinelongated member146 extends from theleading end portion34dof theanchor18d. Therefore, thepointed end portion148 of the thinelongated member146 forms a point at a location where thepassage152 intersects theend portion34dof theanchor18d. While thepusher member30dand thinelongated member146 are held against movement relative to theinserter28d, the inserter, pusher member, thin elongated member, and anchor are moved as a unit relative to thebody tissue12d. As this occurs, thepointed end portion148 of the thinelongated member146 initiates the formation of an opening at an imperforate area on asurface300dof thebody tissue12d.
• As the thinelongated member146,pusher member30d,anchor18dandinserter28dare moved together relative to thebody tissue12d, theleading end portion34dof theanchor18dmoves into the opening in thebody tissue12dwhich was initiated by thepointed end portion148 of the thin elongated member. Theanchor18dis pressed into thebody tissue12dunder the influence of force applied against the trailing end portion32dof the anchor by theend surface370 on thepusher member30d. At this time, there is no relative movement between the thinelongated member146,pusher member30d,anchor18d, andinserter28d. During movement of theanchor18dinto thebody tissue12d, theanchor18dremains in a position relative to theinserter28dcorresponding to the position of theanchor18 to theinserter28 inFIGS. 2 and 3.
• As the thin elongated member,pusher member30d,anchor18d, andinserter28dare moved together into thebody tissue12dduring the alternative method, thepointed end portion148 on the thin elongated member engages an imperforate area on anouter surface304dof thebone14d. Continued movement of the thinelongated member146,pusher member30d,anchor18dandinserter28dtogether in a direction toward thebone14dresults in initiation of the formation of an opening in theouter surface304dof the hardouter layer278dof thebone14dby the pointed end portion of the thinelongated member146. Continued axial movement of the thinelongated member146,pusher member30d,anchor18dandinserter28dtogether relative to thebone14dmoves theleading end portion34dof theanchor18dinto the hardouter layer278din the same manner as is illustrated inFIG. 3 for theanchor18.
• As this occurs, theinserter28dmoves into abutting engagement with theouter surface304don the hardouter layer278dof thebone14d(FIG. 14). At this time during the alternative method, theend surface370 on thepusher member30dis disposed within theinserter28d. This, thepusher member30dandinserter28dare in the same relationship as is illustrated inFIG. 3 for thepusher member30 andinserter28. At this time, the trailing end portion32dof theanchor18dis enclosed by theinserter28din the same manner as in which the trailingend portion32 of theanchor18 is enclosed by theinserter28 inFIG. 3.
• The thinelongated member146 is then moved through the hardouter layer278dof thebone14dinto thecancellous bone280d(FIG. 14). As the thinelongated member146 moves into thecancellous bone280d, theinserter28d,pusher member30dandanchor18dremain stationary relative to thebone14d. Thus, as the thinelongated member146 is axially advanced into thecancellous bone280d, theinserter28d,pusher member30dandanchor18dremain in the same relationship with thebone14das is illustrated for theinserter28,pusher member30 andanchor18 inFIG. 3.
• When thepointed end portion148 of the thinelongated member146 has moved to a desired depth in thecancellous bone280d, thepusher member30dis moved axially along the thinelongated member146. As this occurs, the leading end surface370 (FIG. 14) on thepusher member30dapplies force against the trailing end portion32dof theanchor18d. This force causes theanchor18dto slide along the thinelongated member146. As thepusher member30dmoves theanchor18dalong the thinelongated member146, theinserter28dand thin elongated member remain stationary in the position illustrated inFIG. 14 relative to the hardouter layer278dof bone.
• Thus during performance of the alternative method, theanchor18d,inserter28d,pusher member30dand thinelongated member146 are all moved together from a position corresponding to a position illustrated inFIG. 2 for theanchor18 to a position corresponding to the position illustrated inFIG. 3 for theanchor18. The thinelongated member146 is then telescopically extended from theanchor18d(FIG. 14) through the hardouter layer278dof bone into thecancellous bone280dwhile theanchor18dandpusher member30dremain stationary relative to thebone14d.
• The thinelongated member146 is supported by theanchor18dandpusher member30dduring the initial formation of an opening in the hardouter layer278dof thebone14d. After the thinelongated member146 has initiated the formation of an opening in the hardouter layer278 of thebone14d, theleading end portion34dof theanchor18denlarges the opening. This positions the anchor in the desired orientation relative to the opening initiated by theelongated member146.
• After the thinelongated member146 has been moved to the desired depth in thebone14dduring performance of the alternative method, theanchor18dis moved axially along the thinelongated member146. As theanchor18dmoves through the hardouter layer278dof bone and moves into thecancellous bone280d, the thinelongated member146 cooperates with thepassage152 in theanchor18dto guide movement of the anchor along an insertion path having a longitudinal central axis which is coincident with a longitudinal central axis of the thinelongated member146.
• Movement of thepusher member30dandanchor18dalong the stationary thin elongated member is interrupted when theanchor18dhas moved to a desired depth in thecancellous bone280d. Indicia, corresponding to theindicia360 ofFIG. 13, is provided on thepusher member30d. This indicia cooperates with theinserter28dto indicate when theanchor18dhas been moved to a desired position in thecancellous bone280. If theanchor18dis being positioned in thecancellous bone280dby a robotic apparatus, in the manner previously discussed, the position of thepusher member30drelative to theinserter28dmay be indicated by the position of a movable element in a drive assembly on an articulate arm of the robotic apparatus.
• In the foregoing description of the alternative method, the thinelongated member146 and theleading end portion34dof theanchor18dare moved together through a short distance into the hardouter layer278dof bone, that is, to a position corresponding to the position of theanchor18 inFIG. 3. The thinelongated member146 is then moved relative to theanchor14d(FIG. 14). However, the thinelongated member156 could be moved through thesoft body tissue12dto a desired depth in thebone14dbefore theanchor18dis moved into engagement with the soft body tissue. However, if desired, the thinelongated member146 andanchor18dcould be moved together through thesoft body tissue12dto the desired depth in thebone14dwithout any relative movement between the anchor and thin elongated member.
• Theanchor20dmay be moved through thesoft body tissue12dinto thehard body tissue14dsimultaneously with movement of theanchor18dthrough the soft body tissue into the hard body tissue. However, if desired, theanchor20dmay be moved through thesoft body tissue12dand into thehard body tissue14dafter theanchor18dhas been moved into the hard body tissue.
• When theanchor20dis to be positioned relative to thebody tissue12dand14din accordance with the alternative method, the thin elongated member160 (FIG. 15) is moved through thepusher member40dwhile thepusher member40d,inserter38d, andanchor20dare spaced from thebody tissue12dand14d. The portion of the thinelongated member160 extending past theend surface374 on thepusher member40dis inserted through thepassage166 in theanchor20d. When this has been done, thepointed end portion162 of the thinelongated member160 will extend a short distance past the pointed leading end portion44dof theanchor20d. This will result in thepointed end portion162 of the thinelongated member160 forming a continuation of the pointed leading end portion44dof theanchor20d.
• The portion of thesuture24dadjacent to theanchor20dis tensioned to press theanchor20dagainst theend surface374 on thepusher member40d. While thepusher member40d, thinelongated member160 andanchor20dare held against movement relative to each other, the thin elongated member, pusher member and anchor are telescopically inserted into theinserter38d. The thinelongated member160,pusher member40dandanchor20dare moved to a position in which theend surface374 of thepusher member40dis enclosed by theinserter38d. At this time, theanchor20dwill be in the same position relative to theinserter38das is theanchor20 relative to theinserter38 ofFIG. 6. However, the thinelongated member160,pusher member40d,inserter38d, andanchor20d(FIG. 15) will all be spaced from thebody tissue12dand14d.
• While the thinelongated member160,pusher member40dandanchor20dare held against movement relative to theinserter38dand only thepointed end162 of the thin elongated member extends from the anchor, the inserter is moved to a desired position relative to thebody tissue12dand14d. In the embodiment of the invention illustrated inFIG. 15, theinserter28dis moved to a position offset from the position in which theinserter28dandpusher member30dhave been used to move theanchor18dalong the thinelongated member146 into thebone14. Thus, as viewed inFIG. 15, the thinelongated member160,pusher member40d,inserter38d, andanchor20dare offset in a direction which is out of the sheet of drawings on whichFIG. 15 is disposed from the location of theanchor18drelative to the sheet of drawings.
• While theanchor20dis in the same orientation relative to theinserter38das is theanchor20 relative to theinserter38 ofFIG. 6, thepointed end portion162 of the thinelongated member160 is moved into engagement with an imperforate area on theouter surface300dof thebody tissue12d. At this time, the trailingend portion42dof theanchor20dis disposed within theinserter38dand is engaged by thepusher member40d, in the same manner as is illustrated inFIG. 6 for theanchor20 andpusher member40. The thin elongated member (FIG. 15) extends through thepusher member40dand through thepassage166 in theanchor20d. Thepointed end portion162 of the thin elongated member is disposed adjacent to and forms a continuation of the pointed leading end portion44dof theanchor20d.
• Thepointed end portion162 of the thinelongated member160 engages the imperforateouter surface300dof thebody tissue12dat the location where theanchor20dis to be inserted into thebody tissue12dand14d. While the thinelongated member160,pusher member40d,inserter38dandanchor20dare held against movement relative to each other, they are pressed into thebody tissue12d. As this occurs, thepointed end portion162 of the thin elongated member initiates the formation of an opening in thesurface300dof thebody tissue12d. Continued movement of the thinelongated member160,inserter38d,pusher member40dandanchor20dtogether into thebody tissue12dresults in the opening which was initially formed by thepointed end portion162 of the thinelongated member160 being enlarged by the pointed leading end portion44dof theanchor20d.
• As the thinelongated member160,pusher member40d,inserter38dandanchor20dcontinue to be moved together toward thebone14d, thepointed end portion162 of the thinelongated member160 moves into engagement with an imperforate area on thesurface304dof thebone14d. At this time, the pointed leading end portion of theanchor20dwill have moved into thebody tissue12d. The right (as viewed inFIG. 15) side of theinserter38dwill have just begun moving into thebody tissue12dwhile the left (as viewed inFIG. 15) side of theinserter38dwill be disposed adjacent to and outside of thebody tissue12d. Of course, the position of the left side of theinserter38drelative to thebody tissue12dwill depend upon the thickness of the body tissue. At this time, the trailingend portion42dof theanchor20dis enclosed by theinserter38d.
• Continued axial movement of the thinelongated member160,pusher member40,inserter38dandanchor20dtogether, that is without relative movement between them, along the insertion path results in thepointed end portion162 of the thin elongated member initiating the formation of an opening in theouter surface304dof thehard layer278dof bone. Continued movement of the thinelongated member160,pusher member40d,inserter38d, andanchor20dalong the insertion path results in the opening which was initiated by the pointed leading end portion162dof the thinelongated member160 being expanded by the pointed leading end portion44dof theanchor20d.
• The thinelongated member160,pusher member40d,inserter38dandanchor20dare held against movement relative to each other until theinserter38dengages theouter surface304don the hardouter layer278dof bone. At this time, thepusher member40d,inserter38dandanchor20dwill be in the same position relative to each as is illustrated inFIG. 6 for theinserter38,pusher member40 andanchor20. At this time, thepointed end portion162 of the thinelongated member160 is disposed adjacent to and forms a continuation of the leading end portion44dof theanchor20d.
• While theanchor20d,inserter38d, andpusher member40dare stationary relative to the hardouter layer278dof thebone14d, the thinelongated member160 is moved along the path of insertion into thebone14d. As this occurs, the thinelongated member160 moves through the hardouter layer278dinto thecancellous bone280d. When the thin elongated member has been moved to a desired depth into the softcancellous bone280d, that is, to the position illustrated inFIG. 15, movement of the thin elongated member into the cancellous bone is interrupted.
• Thepusher member40dis then moved axially along the thinelongated member160 to push theanchor20dthrough the hardouter layer278dinto thecancellous bone280d. As this occurs, the thinelongated member160 andinserter38dare stationary relative to the hardouter layer278dof thebone14d. Thepassage166 in theanchor20dslides along the thinelongated member160 under the influence of force applied against the trailingend portion42dof the anchor by theend surface374 on thepusher member40d.
• When thepusher member40dhas moved theanchor20dto the desired depth into thecancellous bone280d, movement of thepusher member40dandanchor20dalong the thin elongated member is interrupted. Thepusher member40dmay advantageously be provided with indicia, corresponding to theindicia360 ofFIG. 13, which cooperates with theinserter38dto indicate the position of the pusher member and theanchor20drelative to thebody tissue14d. It is contemplated that indicia may be provided on the thinelongated members146 and160. The indicia on the thinelongated members146 and160 would cooperate with theinserters28dand30dto indicate the depth of insertion of the thin elongated members into thebody tissue14d.
• In the foregoing description of the alternative method, the thinelongated member160 and the leading end portion44dof theanchor20dare moved together through a short distance into the hardouter layer278dof bone, that is, to a position corresponding to the position of theanchor20 inFIG. 6. The thinelongated member160 is then moved relative to theanchor20d(FIG. 15). However, the thinelongated member160 could be moved through the soft body tissue to a desired depth in thebone14dbefore theanchor20dis moved into engagement with the soft body tissue. However, if desired, the thinelongated member160 andanchor20dcould be moved together through thesoft body tissue12dto the desired depth into thebone14dwithout any relative movement between the anchor and the thin elongated member.
• As theanchor20dis moved into thecancellous bone280dwith any of the foregoing methods related toFIGS. 14 and 15, thesuture24dis tensioned. In the embodiment of the invention illustrated inFIG. 15, thesuture24dforms a continuous closed loop which extends through theanchors18dand20din the manner illustrated schematically inFIG. 11 for thesuture24a. Therefore, as theanchor20dis moved into thecancellous bone280d,connector portions48dand90dof thesuture24dare tensioned between theanchors18dand20d. A tension measuring device, corresponding to the tension measuring device96 ofFIG. 12, may be provided to measure the tension in thesuture24d. If a tension measuring device, corresponding to the tension measuring device96 ofFIG. 12, is utilized to measure the tension in thesuture24d(FIG. 15), the movement of theanchor20dinto thecancellous bone280dis interrupted when there is a desired tension in theconnector portions48dand90dof thesuture24d.
• It should be understood that thesuture24dcould have a pair of leg portions, corresponding to theleg portions50 and52 of thesuture24 ofFIG. 9, which are interconnected by a suture retainer or crimp, corresponding to the suture retainer or crimp54 ofFIG. 9. If this was done, a force application assembly, corresponding to theforce application assembly60 ofFIG. 10, could be utilized to determine when the desired tension force was present in thesuture24d(FIG. 15).
• If theanchor18dis moved into thecancellous bone280dprior to movement of theanchor20dinto the cancellous bone, thesuture24dwill be tightened with a desired tension force during insertion of theanchor20dinto thecancellous bone280d. However, if both anchors18dand20dare inserted at the same time into thecancellous bone280d, thesuture24dwill be tightened to the desired tension during movement of both anchors into thecancellous bone280d.
• If desired, the step of measuring the tension in thesuture24dcould be omitted. If this was done, theanchors18dand20dwould merely be moved to a desired depth into thecancellous bone280d. By properly sizing the loop formed by thesuture24dand selecting the locations of the insertion paths for theanchors18dand20d, a desired tension would be obtained in thesuture24dwhen theanchors18dand20dhave been moved to a desired depth into thecancellous bone280d. However, it is believed that it may be desired to actually measure the tension in thesuture24dto be certain that a desired tension is obtained when theanchors18dand20dhave been moved into thecancellous bone280d.
• If desired, theanchors18dand20dmay be left in the orientation illustrated inFIG. 15 relative to thecancellous bone280dand the hardouter layer278d. Alternatively, theanchors18dand20dmay be toggled or pivoted relative to thecancellous bone280d. In either situation, theanchors18dand20dwould be supported in thecancellous bone280din a spaced apart relationship with the hardouter layer278d.
• When theanchor18dis to be pivoted relative to thecancellous bone280, the thinelongated member146 is first completely withdrawn from theanchor18d. While thepusher member30dis pressed against the trailing end portion of theanchor18d, thesuture24dis tensioned to cause a pivoting movement of theanchor18drelative to thepusher member30din the manner illustrated schematically inFIGS. 4 and 5 of theanchor18.
• Similarly, if the orientation of theanchor20dis to be changed relative to thecancellous bone280d, the thinelongated member160 is completely withdrawn from theanchor20d. While thepusher member40dis pressed against the trailing end portion of theanchor20d, the tension in thesuture24dcauses the anchor to pivot from the orientation shown inFIG. 7 for theanchor20 to the orientation shown inFIG. 8 for theanchor20.
• In the embodiment of the invention illustrated inFIG. 15, thesuture24dextends in a continuous closed loop between the twoanchors18dand20d. Thesuture24dis not tensioned until both anchors18dand20dhave been moved into thebody tissue14d. Therefore, if the orientation of theanchors18dand20dis to be changed from the orientation illustrated inFIG. 15 to the orientation illustrated inFIG. 9 of theanchors18 and20, both anchors may be pivoted at the same time in thecancellous bone280d.
• To effect simultaneous pivotal movement of theanchors18dand20din thecancellous bone280d, the thinelongated member146 is withdrawn from theanchor18dand the thinelongated member160 is withdrawn from theanchor20dwhile the anchors are disposed in the orientation illustrated inFIG. 15 in thebody tissue280d. Bothpusher members30dand40dare then simultaneously pressed against the trailing end portions of theanchors18dand20d. The resulting tension in thesuture24dcauses theanchor18dto pivot in a counterclockwise direction about the end portion of thepusher member30d. At the same time, the tension in thesuture24dcauses theanchor20dto pivot in a clockwise direction about the end portion of thepusher member40d. Of course, theanchors18dand20dcould be sequentially pivoted in thecancellous bone280dif desired.
• In the specific embodiment of the invention illustrated inFIGS. 14 and 15, theanchors18dand20dare moved along linear insertion paths into thebody tissues12dand14d. Therefore, the thinelongated members146 and160 have linear configurations. However, it is contemplated that it may be desired to move theanchors18dand20dinto body tissues along nonlinear insertion paths.
• When theanchors18dand20dare to be moved into body tissues along nonlinear insertion paths, theelongated members146 and160 have a nonlinear configuration. For example, if theanchors18dand20dare to be moved along arcuate insertion paths relative to thebody tissues12dand14d, the thinelongated members146 and160 would have portions with an arcuate configuration. The portions of the thin elongated members having an arcuate configuration would have an arcuate configuration which is the same as the arcuate configuration of the desired insertion paths. Theanchors18dand20dwould be moved along the arcuate portions of the thin elongated members into thebody tissues12dand14d.
• It is contemplated that the desired anchor insertion paths into thebody tissues12dand14dcould have arcuate configurations corresponding to the arcuate configurations of a portion of a circle. In this situation, at least a portion of the thinelongated members146 and160 would have arcuate configurations corresponding to the configuration of a portion of a circle. For example, the thinelongated members146 and160 could have portions with a circular arcuate extent of 135°.
• After the arcuate thinelongated members146 and160 have been positioned relative to thebody tissues12dand14d, theanchors18dand20dwould be moved along the arcuate extent of the thin elongated members. Theanchors18dand20dmay havepassages152 and166 with arcuate configurations corresponding to the arcuate configurations of the thinelongated members146 and160. Thepusher members30dand40dwould also have arcuate configurations corresponding to the arcuate configurations of the thinelongated members146 and160. The arcuate configurations of theanchor passages152 and166 and the arcuate configurations of thepusher members30dand40dwould facilitate movement of the anchors along the arcuate portions of the thin elongated members under the influence of force transmitted to the anchors from the pusher members.
• If desired, thepusher members30dand40dcould have flexible constructions to enable the pusher members to bend as they move along the arcuate portions of the thinelongated members146 and160. For example, thepusher members30dand40dcould be formed of a polymeric material and be resiliently deflected by the arcuate portion of the thinelongated members146 and160. Alternatively, thepusher members30dand40dcould be formed of tightly coiled spring wire.
• It is contemplated that it may be desired to move theanchors18dand20dalong helical insertion paths into thebody tissues12dand14d. The thinelongated members146 and160 would be formed with helical configurations corresponding to the helical configurations of the anchor insertion paths. The thinelongated members146 and160 would be moved into thebody tissues12dand14dwith a screwing action by rotating the thin elongated members about a straight central axis of the helix. Theanchors18dand20dwould be moved along the helical portions of the thinelongated members146 and160 bypusher members30dand40dhaving a helical configuration. Alternatively, thepusher members30dand40dcould have a flexible construction to enable the pusher members to conform to turns in the helical portions of each of the thinelongated members146 and160.
• In the embodiment of the invention illustrated inFIGS. 14 and 15, the thin elongated members are offset from each other in the direction of the sheet on whichFIG. 15 of the drawings is disposed. However, it is contemplated that the thinelongated members146 and160 could be positioned relative to each other with their central axes in a common plane. If this is done, the pointed end portion148 (FIG. 14) of the thinelongated member146 and thepointed end portion162 of the thinelongated member160 would be disposed in engagement when the thin elongated members have been inserted into thebody tissue12dand thebody tissue14d. This would facilitate positioning of theanchors18dand20din engagement with each other, in a manner similar to that illustrated inFIG. 20 for theanchors18gand20g.
Embodiment of FIG.16
• Aguide assembly120efor guiding movement of suture anchors into body tissue is illustrated schematically inFIG. 16. Theguide assembly120ehas the same general construction and mode of operation as theguide assembly120 ofFIG. 13. Theguide assembly120eis illustrated inFIG. 16 in association withsoft body tissue12eand14e. Thesoft body tissue12eis formed as a relatively thin layer. Thebody tissue14eis formed as a relatively thick mass.
• Theguide assembly120eis utilized to guide movement of suture anchors corresponding to the suture anchors18 and20 ofFIG. 1 along insertion paths into thebody tissue14dwith a suture, corresponding to thesuture24 ofFIG. 1 extending between the suture anchors. However, theguide assembly120ecould be used in association with a suture which extends in a continuous loop between a pair of suture anchors. The continuous suture loop would be utilized in the same manner as described in conjunction withFIG. 11.
• Theguide assembly120eincludes a linear base124ewhich is positioned in abutting engagement with anouter surface300eof thelayer12eof body tissue. At this time, theguides126eand128eare withdrawn from openings in slide blocks380 and382 in theguide assembly120e. The slide blocks are then moved alongslots384 and386 in the base124euntil cylindrical openings which extend through the guide blocks are aligned with desired insertion locations for the anchors.
• Theguide126eis then positioned in the opening in theslide block380. Theguide126eis pressed axially into thebody tissue12eand thebody tissue14eto the position illustrated schematically inFIG. 16. Theguide128eis then pressed axially into the body tissue124eand114eto the position illustrated schematically inFIG. 16.
• Once theguides126eand128ehave both penetrated thesoft body tissue12eand14e, anchors, corresponding to theanchors18 and20 ofFIG. 1, are positioned incylindrical passages392 and394 formed in theguides126eand128e. Pusher members, corresponding to thepusher members30 and40 ofFIGS. 2-8, are then utilized to move theanchors18 and20 along theguides126eand128ethrough the layer124eof soft body tissue into the mass14eof soft body tissue. As this occurs, the suture extending between the anchors moves alongslots292eand316ein the side walls of the tubular guides126eand128e. If the suture has the construction of thesuture24 ofFIG. 1, the leg portions of the suture are tensioned after the anchors have been moved into the mass14eof soft body tissue. However, if the suture has the loop construction illustrated inFIG. 11, the suture is tensioned as the anchors are moved into thesoft body tissue14e.
• The slotted guides126eand128eare positioned with their longitudinal central axes extending transverse to each other. This results in the anchor which is moved along theguide126e, that is the anchor corresponding to theanchor18 inFIG. 1, moving toward theguide128eas the anchor is moved into the body tissue. Similarly, the anchor which is moved along theguide128e, that is, theanchor20 inFIG. 1, moves toward theguide126eas the anchor is moved into thebody tissue14e. The anchors may be left in thebody tissue14ewith their longitudinal central axes extending parallel to longitudinal central axes of theguides126eand128e. Alternatively, the anchors may be pivoted or toggled to positions and orientations corresponding to the orientations of theanchors18 and20 inFIG. 10.
• Once the anchors have been positioned in the body tissue with the suture extending between the anchors, theguides126eand128eare withdrawn from thebody tissue12dand14d. Tension in the suture which extends between the anchors, is effective to press the layer124eof body tissue firmly against the relatively large mass14eof body tissue.
Embodiment of FIG.17
• In the embodiment ofFIG. 17, theanchors18fand20fand thesuture24fare utilized to pressbone12fon one side of afracture178 against bone14fon the other side of the fracture. Theanchors18fand20fand thesuture24fhave the same construction as theanchors18 and20 andsuture24 ofFIGS. 1-10. To secure the body tissue orportion12fof thebone174 to the body tissue or portion14fof the bone, the two portions of the bone are firmly pressed together at thefracture178.
• When theanchor18fis to be positioned relative to thebone174, the anchor is positioned in an inserter, corresponding to theinserter28 ofFIG. 2. A pusher member, corresponding to thepusher member30 ofFIG. 2, is positioned in the inserter and engages a trailing end portion of theanchor18f. Theanchor24fis held in the inserter with a leading end portion34f(FIG. 17) of the anchor extending from the inserter in the same manner as is illustrated inFIG. 2. At this time, thesuture18fextends along a slot in the inserter. Thus, thesuture24fextends along a slot corresponding to theslot292 in theinserter28 ofFIG. 2.
• The longitudinal central axis of the inserter is then positioned in a desired orientation relative to theportion12fand the portion14fof thebone174. The orientation of the inserter corresponds to the path along which theanchor18fis to be moved into and through theportion12fof thebone174 and into and through the portion14fof the bone. If theanchor18fis to be moved straight downward (as viewed inFIG. 17) through theportions12fand14fof thebone174, the inserter would be positioned with its longitudinal central axis extending generally perpendicular to theouter surface300fof the portion14fof thebone174. However, in the embodiment of the invention illustrated inFIG. 17 it is preferred to move the anchor along a path which is skewed relative to theouter surface300fof thebone174. The inserter may be positioned with its longitudinal axis extending at an angle of between 30° and 90° to theouter surface300fof the bone.
• With the inserter in the desired orientation relative to thesurface300fof thebone174, the pointed leading end portion34fof theanchor18fis pressed against an imperforate area on theouter surface300fof thebone174. The pointed leading end portion34fof theanchor18fthen initiates formation of an opening in theportion12fof thebone174. However, if desired, a drill or similar tool could be utilized to form a passage extending through theportion12fand the portion14fof the bone at the desired angle relative to thesurface300fof the bone. This passage could have a diameter which is either slightly smaller or slightly greater than the outside diameter of theanchor18f. If the diameter of the passage which is drilled through thebone174 is less than the outside diameter of the anchor, the anchor would be effective to expand the passage as the anchor moves into theportion12fof the bone.
• Assuming that theanchor18fis utilized to form a passage in thebone174, the pointed leading end portion of the anchor penetrates a hardouter layer278fof thebone174 and moves intocancellous bone280fwhich is enclosed by the hardouter layer278f. As this occurs, the pusher member, corresponding to thepusher member30 is telescopically extended from the inserter, in the manner illustrated schematically inFIG. 4 for thepusher member30 andinserter28. This moves theanchor18fthrough theportion12fof thebone174 and through the portion14fof the bone.
• Immediately after theanchor18femerges from the lower (as viewed inFIG. 17) side of thebone174, thesuture24fis tensioned and the anchor is pivoted or toggled to the position illustrated inFIG. 17. After theanchor18fhas been toggled to the position illustrated inFIG. 17, the pusher member is withdrawn from the bone.
• Theanchor20fis moved through theportion12fof thebone174 into the portion14fof thebone174, in the manner indicated schematically in solid lines inFIG. 17. Theanchor20fis moved through the portion14fof thebone174 and toggled to the position illustrated in dashed lines inFIG. 17.
• When theanchor20fis to be moved through thebone174, the anchor is positioned in theinserter38fwhich has the same construction as theinserters28 and38 ofFIGS. 2-8. The pusher member40fis telescopically moved along theinserter38finto engagement with the trailing end portion of theanchor20f. Thesuture24fhas the same construction as thesuture24 ofFIG. 1. Therefore, aleg portion52fand aconnector portion48fmay be received in a slot in theinserter38fin the same manner as previously described in conjunction with the embodiment of the invention illustrated inFIGS. 2-8.
• Theinserter38fand pusher member40fare positioned in an angular orientation relative to thesurface300fof thebone174 corresponding to the angle of the desired path of insertion of theanchor20finto thebody tissue12 and14. In this specific embodiment of the invention illustrated inFIG. 17, the path of insertion of theanchor20finto thebone174 is skewed at an angle of between 55° and 60° relative to the surface30f. It is contemplated that the path of insertion of theanchor20finto thebone174 may be located at an angle between 30° and 90° relative to thesurface300 of thebone174. As was previously mentioned in conjunction with theanchor18f, a passage extending through thebone174 may be preformed by a drill or other tool.
• Assuming that theanchor20fis to be utilized to form its own passage through thebone174, when a leading end portion44fof theanchor20fengages an imperforate surface on theouter surface300fof theportion12fof thebone174, the leading end portion of the anchor initiates formation of an opening in the outer surface of theportion12fof thebone174. Continued movement of the pusher member40falong the path of insertion of the anchor into thebone174 results in the anchor moving into the hardouter layer278fof the bone. Continued movement of the pusher member40frelative to theinserter38fresults in the anchor moving into thecancellous bone280fin theportion12fof thebone174. As the pusher member40fcontinues to move theanchor20finto thebone174, the anchor moves across thefracture178 in the manner illustrated schematically inFIG. 17, as theanchor20fmoves through thecancellous bone280f.
• Theanchor20fthen moves through the hardouter layer278fof theportion14 of thebone174. Once the anchor has moved out of the bone14fat the lowest (as viewed inFIG. 17) side of the bone, thesuture24 is tensioned and the anchor is toggled to the position illustrated in dashed lines inFIG. 17.
• Once theanchor18fhas been moved to the position illustrated in solid lines inFIG. 17 and theanchor20fhas been moved to the position illustrated in dashed lines inFIG. 17, ends ofleg portions50fand52fof thesuture24fare tensioned. As this occurs, thesuture24fslides into passages formed in theanchors18fand20f. As theleg portions50fand52fof thesuture24fare tensioned, theconnector portion48fof the suture is tensioned. Any excess material in theconnector portion48fof thesuture24fis pulled from theconnector portion48finto either one or both of theleg portions50fand52fof thesuture24f. A retainer, corresponding to theretainer54 ofFIG. 9, may be utilized to interconnect theleg portions50fand52fof thesuture24f. Alternatively, a knot may be utilized to interconnect theleg portions50fand52fif desired.
• A force application assembly, corresponding to theforce application assembly60 ofFIG. 10 may be utilized to apply a predetermined tension force to theleg portions50fand52fof thesuture24f. In addition, a force application member, similar to theforce application member66 ofFIG. 10, may be utilized to press a crimp against thebone174 as thesuture24fis tensioned. While the desired tension force is being applied to the suture and while the crimp is being pressed against the bone with the desired force, force application members, corresponding to forceapplication members76 and78 ofFIG. 10, may be utilized to plastically deform the suture retainer.
• It is believed that a guide assembly, similar to theguide assembly120 ofFIG. 13, may advantageously be utilized when theanchors18fand20fare being moved into the bone174f. The guide assembly may have guides, corresponding to theguides126 and128 ofFIG. 13, which engage theanchors18fand20fand the associated pusher members corresponding to thepusher members30 and40 ofFIGS. 1-8. Alternatively, the guides could be utilized to position inserters, corresponding to theinserters28 and38 ofFIGS. 2-8.
• When theanchors18fand20fofFIG. 17 are being moved into thebone174, it is believed that the use of thin elongated members, corresponding to the thinelongated members146 and160 ofFIG. 15, may advantageously be utilized to guide movement of theanchors18fand20falong preselected paths. Thus, the thin elongated members would be moved through thebone174. One of the thin elongated members would be moved through thebone174 along an insertion path to be followed by theanchor18f. The other thin elongated member would be moved through thebone174 through an insertion path to be followed by theanchor20f.
• Small passages may be predrilled in thebone174 to receive the thin elongated members. The predrilled holes for the thin elongated members may have a diameter which is slightly less than the diameter of the thin elongated members. Once the thin elongated members have been moved through thebone174, theanchors18fand20fare moved along the thin elongated members through thebone174.
Embodiment of FIGS.18 and19
• The anchors ofFIGS. 1-17 all have the same general construction. However, it is contemplated that the anchors could have a different construction if desired. For example, the anchors could be constructed in the manner generally similar to the construction of theanchor186 ofFIG. 18. Theanchor186 has a plurality of barbs, that isbarbs192,194 and196. Thebarbs192,194 and196 engage body tissue to hold theanchor186 against movement relative to the body tissue. Of course, the anchor could be provided with barbs or projections having a construction which is different than the construction of the barbs orprojections192,194 and196 if desired.
• Theanchor186 has a known construction. The construction of theanchor186 is the same as is disclosed in U.S. Pat. No. 5,725,557. However, it should be understood that theanchor186 is typical of many different known anchor constructions having projections or barbs which engage either soft or hard body tissue to retain the anchor against movement relative to the body tissue. Any one of these known anchors could be utilized in place of theanchor186 if desired. Theanchor204 ofFIG. 19 has a threadedportion206 which engages body tissue to hold the anchor against movement relative to the body tissue. Although it is believed that the threadedportion206 may be most effective to hold theanchor204 against movement relative to bone, the anchor could be utilized in association with soft body tissue if desired.
• Theanchor204 has a known construction. The construction of theanchor204 is the same as is disclosed in U.S. Pat. No. 5,443,482. However, it should be understood that theanchor204 could have a different construction if desired.
Embodiment of FIGS.20 and21
• In the embodiment of the invention illustrated inFIGS. 20 and 21, theanchors18 and20 are moved intobody tissue12gand14galong insertion paths which intersect in the body tissue14g. InFIG. 20, the longitudinal central axes of the insertion paths along which theanchors18gand20gare moved into thebody tissue12gand14gare disposed in a single flat plane.
• Theanchors18gand20gare advantageously interconnected at the location where the paths of insertion of the anchors into thebody tissue12gand14gintersect. It is believed that movement of theanchors18gand20galong intersecting insertion paths into thebody tissue12gand14gmay be facilitated by the utilization of a guide assembly, corresponding to theguide assembly120 ofFIG. 13. In addition, thin elongated members, corresponding to the thinelongated members146 and160 ofFIG. 15, may be utilized to further guide movement of theanchors18gand20g.
• Although theanchors18gand20ghave been illustrated inFIG. 20 in association withsoft body tissue12ghaving an arcuateouter surface300gand hard body tissue or bone14ghaving an arcuateouter surface304g, it is contemplated that theanchors18gand20gcould be moved into body tissue having outer surfaces with many different configurations, including an irregular or flat configuration. It should also be understood that theanchors18gand20gmay be utilized in association with just soft body tissue. For example, theanchors18gand20gcould be utilized to connect one piece of soft body tissue, corresponding to thebody tissue12gofFIG. 20, with another piece of soft body tissue, corresponding to the body tissue14gofFIG. 20.
• Theanchors18gand20gmay be sequentially moved through thebody tissue12gand into the body tissue14gor may be simultaneously moved through thebody tissue12ginto the body tissue14g. Assuming that theanchors18gand20gare sequentially moved through thebody tissue12gand into the body tissue14g, theanchor18gis first moved through thebody tissue12ginto the body tissue14g. An inserter member and a pusher member, corresponding to theinserter28 andpusher member30 ofFIG. 2, are utilized to move theanchor18ginto the body tissue14g. If a guide assembly, similar to theguide assembly120 ofFIG. 13, is utilized to facilitate movement of theanchor18galong a desired insertion path, the inserter, corresponding to theinserter28 ofFIG. 1, may be omitted and the anchor moved along a guide, corresponding to theguide126 ofFIG. 13.
• The pusher member which is utilized to move theanchor18gthrough thebody tissue12gand into the body tissue14gmay advantageously be provided with indicia, corresponding to theindicia360 on thepusher member132 ofFIG. 13. When theindicia360 on the pusher member indicates that theanchor18ghas been moved to the desired depth in the body tissue14g, movement of the anchor into the body tissue is interrupted.
• Theanchor20gis then moved through thebody tissue12ginto the body tissue14g. The path of movement of theanchor20gthrough thebody tissue12ginto the body tissue14gintersects the path of movement of theanchor18g. It is contemplated that the use of a guide assembly, corresponding to theguide assembly120 ofFIG. 13, will facilitate movement of theanchor20galong an insertion path which intersects the insertion path of theanchor18g. However, if desired, theanchor20gcould be moved along its insertion path without the benefit of a guide assembly corresponding to theguide assembly120 ofFIG. 13.
• It is believed that it may be desired to utilize thin elongated members, corresponding to the thinelongated members146 and160 ofFIG. 15, to position theanchors18gand20grelative to thebody tissue12gand14g. Of course, if this was done, passages, corresponding to thepassages152 and166 in theanchors18dand20dofFIG. 15, would be provided in theanchors18gand20g.
• In the embodiment of the invention illustrated inFIG. 20, theanchors18gand20geach have a portion of asuture24gextending from the anchors. Thus, aleg portion50gof suture material is secured to theanchor18gand extends from the anchor to theretainer54g. Similarly, a leg portion52gof the suture material is fixedly connected to theanchor20gand extends to theretainer54g. In the embodiment of the invention illustrated inFIG. 20, there is no connector portion, corresponding to theconnector portion48 ofFIGS. 1 and 9, of thesuture24gextending between the twoanchors18gand20g. Thus, theleg portions50gand52gof thesuture24gare formed as separate segments. Of course, thesuture24gcould be provided with a connector portion, corresponding to theconnector portion48 ofFIGS. 1 and 9 if desired.
• Theanchors18gand20gare interconnected at the location where the paths along which they move through thebody tissue12ginto the body tissue14gintersect. The manner in which theanchors18gand20gare interconnected is illustrated schematically inFIG. 21.
• Theanchor18ghas a leading end portion34gwhich engages aleading end portion44gof theanchor20g. Although theleading end portions34gand44gof theanchors18gand20ghave a generally conical configuration, corresponding to the conical configuration of the leadingportions34 and44 of theanchors18 and20 (FIG. 1). It is contemplated that theleading end portions34gand44gof theanchors18gand20gcould have a different configuration if desired. For example, theleading end portions34gand44gof theanchors18gand20gcould have generally wedge-shaped configurations. Alternatively, theleading end portions34gand44gof the anchors could be formed with hooks and/or loops.
• In the illustrated embodiment of the invention, the leading end portion34gof theanchor18gis formed with annular projections212 (FIG. 21) which engageannular projections214 on theleading end portion44gof theanchor20g. Theannular projections212 on theanchor18gextend around the end portion34gof the anchor. Similarly, theannular projections214 on theanchor20gextend around theend portion44gof the anchor.
• Theprojections212 and214 on theanchors18gand20gengage each other as theanchor20gmoves along its insertion path into engagement with theanchor18g. Theprojections212 and214 become interconnected in such a manner as to interconnect theanchors18gand20g. Thus, theprojections212 and214 become intermeshed to prevent separation of theanchors18gand20g.
• It is contemplated that theleading end portions34gand44gof theanchors18gand20gcould be interconnected in a different manner other than by the use of projections corresponding to theprojections212 and214. Thus, one of the anchors, for example, theanchor18g, could be provided with a plurality of hooks which would engage a plurality of loops on the other anchor, that is, theanchor20g. If desired, theanchors18gand20gcould be formed of materials having magnetic poles such that theleading end portions34gand44gof theanchors18gand20gare attracted to each other. It is contemplated that magnetic force may be utilized to promote engagement of theleading end portions34gand44gof theanchors18gand20gwith any one of many different types of interconnections between theanchors18gand20g. If this was done, the magnetic forces between theanchors18gand20gwould be utilized to promote engagement of one portion of a mechanical interconnection on theanchor18gwith another portion of a mechanical connection on theanchor20g.
• If desired, fiberoptics could be positioned along the paths of movement of theanchors18gand20ginto the body tissue14g. One of more guide members could be inserted through one or more cannulas into engagement with the leading end portion of either theanchor18gor20gor both of the anchors to apply force to the anchors to promote engagement of theleading end portions34gand44gof the anchors. If this was done, one of the guide members could be utilized to actuate an interconnection device between theanchors18gand20g. For example, the guide member could be utilized to actuate a latch so that the latch would lock theleading end portions34gand44gof theanchors18gand20gtogether.
Embodiment of FIG.22
• The embodiment of the invention illustrated inFIG. 22 is similar to the embodiment of the invention illustrated inFIGS. 20 and 21. However, in the embodiment of the invention illustrated inFIG. 22, theanchors18hand20hare interconnected at the location where their insertion paths into the body tissue14hintersect by having one anchor move into an opening in the other anchor.
• In the embodiment of the invention illustrated inFIG. 22, theanchor18his provided with anopening220 into which theanchor20hmoves. Theanchor20hhas a plurality ofretainers224 which engage the portion of theanchor18hforming theopening220 to interconnect the two anchors.
• If desired, theanchor18hcould be provided with a flexible mesh, a series of hooks, and/or a series of loops which are engaged by theanchor20hto interconnect theanchors18hand20h. Thus, a multiplicity of retainers or hooks, corresponding to theretainers224, could be provided at axially spaced apart locations along the body of theanchor20hto engage openings formed by loops or a mesh connected with theanchor18h. It should be understood that the openings or mesh provided by theanchor18hcould be formed by one or more extensions from theanchor18h.
• It is believed that accurate movement of theanchors18hand20halong insertion paths which intersect in the body tissue14hmay be promoted by the use of a robotic assembly to position the anchors. Thus, an inserter assembly connected to one articulate arm of a robotic assembly could be utilized to position theanchor18hin the body tissue14hand a second articulate arm of the robotic apparatus could be utilized to position theanchor20hin the body tissue14h. If desired, a guide assembly, corresponding to theguide assembly120 ofFIG. 13, could be utilized in association with the robotic arms. If this was done, the guide assembly could be connected with one of the robotic arms for movement therewith relative to the other robotic arm. Accurate placement of theanchors18hand20hat the desired depth in the body tissue would be facilitated by pusher member drive assemblies on the robotic arms.
Embodiment of FIG.23
• In the embodiments of the invention illustrated inFIGS. 1-22, anchors have been completely enclosed by the body tissue into which they are inserted. Thus, theanchors18 and20 have been completely enclosed by the body tissue14 (FIG. 9) into which the anchors are inserted. In the embodiment of the invention illustrated inFIG. 23, anchors18jand20jare only partially enclosed by the body tissue into which they are inserted. Portions of theanchors18 and20 extend from the body tissue.
• In the embodiment of the invention illustrated inFIG. 23, a portion of theanchor18jis inserted through thebody tissue12jinto the body tissue14j. Thus, theshank portion230 of theanchor18jis inserted through thebody tissue12jinto the body tissue14j. Similarly, theanchor20jis provided with a shank portion which is inserted through thebody tissue12jinto the body tissue14j.
• In the embodiment of the invention illustrated inFIG. 23, thesuture24jis connected with theshank portions230 and238 of theanchors18jand20jimmediately beneathhead end portions234 and242 of the anchors. However, thesuture24jcould be connected with theshank portions230 and238 of theanchors18jand20jat a location spaced from thehead end portions234 and238 of the anchors.
• For example, theshank portion230 of theanchor18jcould be provided by an opening which is engaged by thesuture24jand which moves into the body tissue14jwhen theanchor18jmoves into the body tissue. This opening could be formed as a recess which functions as a hook to engage a bend in thesuture24j. The hook in theshank portion230 of theanchor18jcould be formed adjacent to a pointed leading end portion34jof theshank portion230. Alternatively, a hole could extend diametrically through theshank portion230 of theanchor18j. The opening through which thesuture24jextends could be formed adjacent to the leading end portion34jof theanchor18jor at any desired location along theshank portion230 of theanchor18j.
• Theanchor20jmay be provided with a series of generally hook-shaped recesses in the shank portion238jof the anchor. These recesses may be provided at axially spaced apart locations along theshank portion238 of theanchor20j. The suture234jmay be formed as a loop, in the manner indicated schematically inFIG. 11 for the suture20a. If this is done, the suture loop could be moved into engagement with a recess in theshank portion238 of theanchor20jwhich would result in a desired amount of tension being removed from thesuture24jas theshank portion238 of theanchor20jmoves through thebody tissue12jinto the body tissue14j.
• For example, if there is a relatively large amount of slack in thesuture24j, the suture would engage a recess adjacent to a pointed leading end portion44jof theanchor20j. However, if there was relatively little slack in thesuture24j, the suture would be disposed in engagement with a recess spaced along theshank portion238 at a distance from the pointed leading end portion44jof theanchor20j. It is contemplated that a series of recesses could be provided along theshank portion238 of theanchor20jto engage thesuture24jeven if the suture is positioned beneath thehead end portion234 of theanchor18j, in the manner illustrated inFIG. 23, rather than being disposed in engagement with a recess or opening in theshank portion230 of theanchor18j.
• Thehead end portions234 and242 on theanchors18jand20jengage thebody tissue12jto limit the extent of movement of the anchors into the body tissue14j. In addition, thehead end portions234 and242 of theanchors18jand20jpress thesuture24jagainst thebody tissue12jto facilitate locating thesuture24jin a desired orientation relative to the body tissue. If thesuture24jengages a hole or a recess in ashank portion230 or238 of ananchor18jor20j, thehead end portions234 and242 could be omitted. Alternatively, the head end portions could be provided with slots or notches through which the suture would extend. The notches or slots in thehead end portions234 and242 of theanchors18jand20jmay be located on sides of the anchors opposite from the other anchor. Thus, the recess or slot in thehead end portion234 of theanchor18jwould be provided on a side of theanchor18jopposite from theanchor20j. Thesuture24jwould extend from an opening or recess in theshank portion230 of theanchor18jinto the slot. Thesuture24jwould then extend across thehead end portion234 of theanchor18jto theanchor20j. By having thesuture24jextend across thehead end portion234 of theanchor18j, any tendency for the suture to cut thesoft body tissue12jwould be minimized.
• The loop forming thesuture24jwould then be moved across thehead end portion242 of theanchor20jinto a notch or slot inside of thehead end portion242 of theanchor20jopposite from theanchor18j. Thesuture24jwould then be pulled downward (as viewed inFIG. 23) along theshank portion238 of theanchor20jand engaged with a selected recess of a series of recesses in theshank portion238 of theanchor20j. Once this has been done, theanchor20jwould be moved through thebody tissue12jinto the body tissue14j. Since the path of movement of theanchor20jthrough thebody tissue12jinto the body tissue14jextends transverse to the path of movement of theanchor18jthrough thebody tissue12jand into the body tissue14j, the tension in thesuture24jwould be increased as theanchor20jmoves into the body tissue14j.
CONCLUSION
• The present invention relates to a new and improved method of securing afirst body tissue12 with asecond body tissue14. Thefirst body tissue12 may be a soft body tissue and thesecond body tissue14 may be a hard body tissue. Alternatively, the first andsecond body tissues12 and14 may both be soft body tissues. It is also contemplated that both the first andsecond body tissues12 and14 could be hard body tissues.
• When the first and second body tissues are to be interconnected, afirst anchor18 is moved into thesecond body tissue14. If desired, thefirst anchor18 could be moved into and through thesecond body tissue14. Asecond anchor20 is also moved into thesecond body tissue14. If desired, thesecond anchor20 could be moved into and through thesecond body tissue14. Thefirst body tissue12 may be pressed against or otherwise secured with thesecond body tissue14 under the influence of force transmitted from thesuture24 to thefirst body tissue12.
• Thesuture24 which extends between theanchors18 and20 may be tensioned by moving at least one of theanchors18 and20 into the body tissue along a path which extends transverse to a path along which the other anchor is moved into the body tissue. The paths along which theanchors18 and20 move into thebody tissue14 may extend toward each other. The transverse paths of movement of theanchors18 and20 into thebody tissue14 promote gripping of body tissue with the anchors andsuture24 and promotes tensioning of the suture as the anchors move into the body tissue. Although it is believed that it may be desired to move theanchors18 and20 into the body tissue along transverse paths, it is contemplated that the anchors could be moved into the body tissue along parallel paths if desired.
• A desired tension may be established in thesuture24 by moving theanchors18 and20 into the body tissue (FIGS. 11,13-15, and23). Alternatively, a desired tension may be established in thesuture24 by applying force to portions of the suture and then interconnecting the portions of the suture (FIGS. 1-10,12,17, and20-22). Aretainer54 or a knot may be utilized to interconnect portions of thesuture24.
• Regardless of how the tension is established in thesuture24, it may be desired to establish a predetermined tension in the suture. This may be done by determining the tension in thesuture24 as the anchors are moved into the body tissue (FIG. 12). Alternatively, the tension in thesuture24 may be determined during movement of a retainer relative to portions of the suture prior to gripping of the suture with the retainer (FIG. 10).
• Thesuture24 may be a continuous loop (FIGS. 11,13-15, and23) which extends between the twoanchors18 and20. The tension in the loop may be determined as one or more of theanchors18 and20 are moved into thebody tissue14. Alternatively, thesuture24 may be formed by a pair of separate portions (FIGS. 1-10,12,17 and20-22) which are tensioned after theanchors18 and20 are moved into the body tissue.
• One ormore guides126 and128 may be utilized to facilitate positioning of the anchors for movement along paths disposed in a desired spatial relationship with the body tissue. Theguides126 and128 may have tubular guide surfaces with central axes which extend transverse to each other.
• Leadingend portions34 and44 of theanchors18 and20 may be utilized to initiate the formation of openings in the first and/orsecond body tissue12 and14. The leading end portion of each of theanchors18 and20 may be utilized to pierce soft body tissue, a hard outer layer of bone, and/or cancellous bone as the anchor is moved into the body tissue. If either or both of theanchors18 and20 are associated with body tissue which is bone, one or more of the anchors may be supported in a spaced apart relationship with a hardouter layer278 of bone bycancellous bone280 which is enclosed by the hard outer layer of bone. If desired, passages for the anchors may be formed with a drill or similar tool.
• Theanchors18 and20 may advantageously be interconnected while they are disposed in the body tissue (FIGS. 20-22). When this is done, theanchors18 and20 may be moved along transverse paths which intersect in the body tissue. Theanchors18 and20 may be interconnected at the intersection between the two paths.
• There are a plurality of embodiments of the invention. Each embodiment of the invention has one or more features which may be advantageously utilized with one or more of the other embodiments of the invention. It is contemplated that the various features of the embodiments of the invention may be utilized separately or combined in any one of many different combinations.

Claims (8)

1. A method of securing an object to a first body tissue, the method comprising:

inserting only a portion of an anchor through both the object and the first body tissue; and

fixing the anchor to the object to thereby secure the object to the first body tissue,

wherein the anchor includes a head at a proximal end and a shank extending therefrom and the portion of the anchor inserted through both the object and the first body tissue is the shank.

2. The method ofclaim 1 wherein the shank is substantially smooth.

3. The method ofclaim 2 wherein the step of fixing includes heating the anchor by transmitting ultrasonic vibratory energy to the anchor such that the material becomes moldable and flows when subjected to pressure.

4. The method ofclaim 3 wherein the object is a second body tissue.

5. The method ofclaim 3 wherein the object is a surgical implant.

6. The method ofclaim 5 wherein the surgical implant is connected to the shank immediately adjacent the head.

7. The method ofclaim 6 wherein a lower surface of the head abuts the surgical implant.

8. The method ofclaim 1 wherein the shank is provided with a plurality of hooks at axially spaced apart locations to engage the object.

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