US20060212073A1 - Method and apparatus for securing a suture - Google Patents

Abstract

An improved method and apparatus is provided to secure a suture relative to body tissue. When a predetermined minimum force is being transmitted between a suture retainer and the body tissue, the suture is gripped with the suture retainer by plastically deforming material of the suture retainer. One or more bends may be formed in suture by the suture retainer to increase the holding action between the suture retainer and the suture. The bends in the suture may be formed by wrapping the suture around a portion of the suture retainer. During movement of the suture retainer toward the body tissue, the bends may be moved along the suture. One or more bends may be formed in the suture by bending a tubular member through which the suture extends. The tubular member may be maintained in a bent condition by a C-shaped holder member. Alternatively, the tubular member may be maintained in a bent condition by members which are latched together.

Description

RELATED APPLICATION
• This application is a continuation of U.S. patent application Ser. No. 10/266,231. The aforementioned application Ser. No. 10/266,231 is itself a divisional of U.S. patent application Ser. No. 09/523,442 filed Mar. 10, 2000 (now U.S. Pat. No. 6,475,230). The aforementioned application Ser. No. 09/523,442 is a continuation-in-part of U.S. patent application Ser. No. 09/348,940 filed Jul. 7, 1999 (now U.S. Pat. No. 6,159,234). The aforementioned U.S. patent application Ser. No. 09/348,940 is itself a continuation-in-part of U.S. patent application Ser. No. 08/905,084 filed Aug. 1, 1997 (now U.S. Pat. No. 6,010,525). The benefit of the earlier filing dates of the aforementioned application Ser. Nos. 10/266,231; 09/523,442; 09/348,940 and 08/905,084 is claimed for all material common to this application and the aforementioned applications.
BACKGROUND OF THE INVENTION
• The present invention relates to a new and improved method and apparatus for securing a suture against movement relative to body tissue by using a retainer to grip the suture.
• Difficulty has been encountered in securing sutures against movement relative to body tissue. A knot may be tied in a suture to prevent loosening of the suture. However, the knot weakens a portion of the suture and reduces the overall force transmitting capability of the suture. In addition, a suture which is held by a knot applies force to a relatively small area of the body tissue and tends to cut or separate the body tissue. Many operations are conducted in very restricted space where the tying of a knot is difficult.
• Various methods of securing a suture against movement relative to body tissue are disclosed in U.S. Pat. Nos. 3,513,848; 4,662,068; 4,935,028; 5,306,280; and 5,593,425. Although these and other known methods of securing a suture have, to a greater or lesser extent, been successful, it is desirable to simplify the securing of a suture against movement relative to body tissue. It is also desirable to be certain that the suture applies a desired amount of force to the body tissue when the suture is secured. The overall force transmitting capability of the suture should be maximized without concentrating the force at a small area on the body tissue.
SUMMARY OF THE INVENTION
• The present invention provides a new improved method and apparatus for use of securing a suture relative to body tissue. A portion of the suture is enclosed with a first member. Although the first member may have many different configurations, in one embodiment of the invention, the first member has a tubular configuration. The first member is moved along the suture toward the body tissue with the suture extending through a passage in the first member. The first member is then deformed to change the configuration of the first member. The first member may be deformed by bending the first member to grip the suture which extends through the passage in the first member. The first member is retained in the bent configuration by a holder.
• The holder may have many different constructions that may include either one part or a plurality of parts. In specific embodiments of the holder, the holder forms a recess. The first member is at least partially located in the recess in the holder. The holder applies force against the first member to maintain the first member in its second or bent configuration.
• In one specific embodiment of the invention, the holder is formed as one piece. In another embodiment of the invention, the holder is formed by a plurality of pieces which are interconnected. The holder may be formed with a generally C-shaped configuration to form a recess in which the first member is inserted. Alternatively, the holder may be formed of a plurality of parts which are interconnected with the first member between the parts of the holder.
• It is contemplated that, if desired, the suture retainer could include a first member which is deflected and subsequently released to grip a portion of the suture between the first member and a second member. The suture may be wound for one or more turns around the first member before the first member is released. The first member may be released in a recess formed in the second member to press the suture against the second member with the first member. Alternatively, the second member could be received in a recess in the first member and the suture pressed against the second member by the first member.
• In still other embodiments of the invention, the retainer includes the first and second members which are movable relative to each other to grip the suture between the members. The members may have a tapered configuration and/or a thread convolution which grips the suture. Alternatively, the retainer could be formed with a plurality of fingers which extend into a plurality of recesses to grip the suture. A pair of cam-members may be utilized to apply force against the suture to hold the suture.
• A tissue fixation system constructed in accordance with one of the features of the present invention is used to connect thick and thin layers of tissue. The tissue fixation system is located equal distances from the ends of the thick and thin layers of tissue.
• In should be understood that a suture retainer constructed in accordance with the present invention may have many different configurations. It should also be understood that a suture retainer constructed in accordance with the present invention could hold a suture in many ways. The invention should not, except as required by the claims, be limited to any specific construction of the retainer and/or manner of holding the suture.
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 schematic illustration depicting the relationship of a suture retainer to a suture and body tissue prior to tightening of the suture;
• FIG. 2 is an enlarged sectional view illustrating the manner in which the suture is wrapped around the suture retainer ofFIG. 1 to form bends in the suture;
• FIG. 3 is a schematic illustration depicting the manner in which the suture retainer ofFIG. 2 is pressed against body tissue with a predetermined force and the manner in which a predetermined force is applied to an outer side surface of the suture retainer to plastically deform the suture retainer;
• FIG. 4 is an enlarged fragmentary schematic illustration of a portion ofFIG. 3 and depicting the manner in which the material of the suture retainer grips the suture;
• FIG. 5 is an enlarged fragmentary view of a portion ofFIG. 4 further illustrating the manner in which the material of the suture retainer grips the suture;
• FIG. 6 is a schematic pictorial illustration depicting the manner in which a suture is positioned relative to a base of a second embodiment of the suture retainer;
• FIG. 7 is a schematic illustration, taken along the line7-7 ofFIG. 6, depicting the manner in which a movable arm presses a portion of the suture into a groove formed in the base of the suture retainer to form bends in the suture;
• FIG. 8 is a schematic illustration depicting the manner in which force is applied against the suture retainer ofFIGS. 6 and 7 to plastically deform the suture retainer;
• FIG. 9 is a schematic illustration depicting the manner in which a suture is wrapped around another embodiment of the suture retainer to form bends in the suture;
• FIG. 10 is an enlarged fragmentary sectional view, taken generally along-the line10-10 ofFIG. 9, illustrating the manner in which the suture is disposed in a groove in the suture retainer;
• FIG. 11 is a fragmentary sectional view, generally similar toFIG. 10, illustrating an alternative configuration for the groove in the suture retainer ofFIG. 9;
• FIG. 12 is a schematic illustration depicting the manner in which force is applied against the suture retainer ofFIG. 9 to plastically deform the suture retainer and grip the suture;
• FIG. 13 is a schematic illustration depicting another embodiment of the suture retainer and the manner in which sections of a suture are wrapped in opposite directions to form bends in the suture;
• FIG. 14 is a sectional view, taken generally along the line14-14 ofFIG. 13, illustrating the manner in which the suture is disposed in a groove in the suture retainer;
• FIG. 15 is an enlarged fragmentary schematic illustration of a portion ofFIG. 13, further illustrating the manner in which the suture is disposed in grooves formed in the suture retainer;
• FIG. 16 is a fragmentary schematic sectional illustration of the manner in which the grooves and sections of the suture ofFIG. 15 cross;
• FIG. 17 is a schematic sectional view illustrating the manner in which a suture is wrapped around a roller in another embodiment of the suture retainer;
• FIG. 18 is a schematic illustration depicting the manner in which the suture retainer ofFIG. 17 is urged toward body tissue and the manner in which force is applied against the suture retainer to plastically deform the suture retainer;
• FIG. 19 is a fragmentary schematic illustration, generally similar toFIG. 17, depicting an alternative manner of wrapping the suture around the roller;
• FIG. 20 is a fragmentary schematic illustration of another embodiment of the suture retainer in which a housing encloses a plurality of cylinders around which the suture is wrapped;
• FIG. 21 is a schematic illustration depicting the manner in which the suture zigzags through passages in another embodiment of the suture retainer;
• FIG. 22 is a schematic sectional view, taken generally along the line22-22 ofFIG. 21, further illustrating the manner in which the suture extends through the suture retainer;
• FIG. 23 is a schematic sectional view depicting the manner in which the suture zigzags through passages in another embodiment of the suture retainer;
• FIG. 24 is a schematic sectional view illustrating the manner in which turns of a suture are wrapped in looped around another embodiment of the suture retainer;
• FIG. 25 is a schematic sectional view illustrating the manner in which turns of a suture are wrapped in looped around another embodiment of the suture retainer;
• FIG. 26 is a schematic sectional view illustrating the manner in which a two-section embodiment of the suture retainer is positioned relative to body tissue prior to engagement of the two sections of the suture retainer;
• FIG. 27 is a pictorial illustration of an inner or lower section of the suture retainer ofFIG. 26;
• FIG. 28 is a pictorial illustration of an outer or upper section of the suture retainer ofFIG. 26;
• FIG. 29 is a schematic sectional view of another two-section embodiment of the suture retainer prior to engagement of the two sections of the suture retainer;
• FIG. 30 is a schematic illustration of another two-section embodiment of the suture retainer;
• FIG. 31 is a pictorial illustration of an inner member used in the suture retainer ofFIG. 30;
• FIG. 32 is a schematic sectional illustration depicting the manner in which another embodiment of the suture retainer is pressed against a large area on body tissue with a predetermined force;
• FIG. 33 is a schematic view of the suture retainer ofFIG. 32 after the suture retainer has been plastically deformed to grip the suture;
• FIG. 34 is a schematic illustration depicting the manner in which another embodiment of the suture retainer is pressed against body tissue and the manner in which force is applied against the suture retainer to effect plastic deformation of the suture retainer;
• FIG. 35 is a schematic illustration of a tool which may be used to press the suture retainer ofFIG. 13 against body tissue and to plastically deform the material of the suture retainer;
• FIG. 36 is a schematic illustration of another embodiment of a tool which may be used to press a suture retainer against body tissue and to plastically deform the material of the suture retainer;
• FIG. 37 is an illustration of a chart of available suture sizes and known strengths for each suture size;
• FIG. 38 is a schematic illustration depicting the manner in which a suture is tensioned, a suture retainer is pressed against body tissue, and force is applied against the suture retainer to plastically deform the suture retainer;
• FIG. 39 is a schematic illustration, generally similar toFIG. 38, illustrating another embodiment of the invention;
• FIG. 40 is a schematic pictorial illustration of a holder which may be used with another embodiment of the suture retainer;
• FIG. 41 is a schematic illustration depicting the relationship-of a tubular member to a suture;
• FIG. 42 is a schematic illustration depicting the manner which the holder ofFIG. 40 engages the tubular member ofFIG. 41 to retain the tubular member in a bent configuration;
• FIG. 43 is a schematic illustration, generally similar toFIG. 41, of a second embodiment of the tubular member which may be used with a holder which has a construction similar to the construction of the holder ofFIGS. 40 and 42;
• FIG. 44 is a schematic illustration, generally similar toFIG. 42, illustrating the manner in which a holder is used to maintain a plurality of bends in a tubular member through which a suture extends;
• FIG. 45 is a schematic pictorial illustration depicting the manner in which a suture retainer constructed in accordance with the present invention is pressed against body tissue and is utilized to maintain tension in a suture;
• FIG. 46 is a fragmentary sectional view, taken generally along the line46-46 ofFIG. 45, and illustrating the manner in which a tubular member is held between upper and lower portions of a holder as the tubular member is bent by the application of axial force to the tubular member;
• FIG. 47 is a schematic sectional view, generally similar toFIG. 46, illustrating the manner in which one section of the holder is held against movement relative to another section of the holder to retain the tubular member in a bent configuration with the suture extending through the tubular member and holder;
• FIG. 48 is a plan view of a holder which is used in another embodiment of the suture retainer;
• FIG. 49 is a sectional view taken generally along the line49-49 ofFIG. 48, further illustrating the construction of the holder;
• FIG. 50 is a plan view of a resiliently deflectable member, illustrating the manner in which a suture is wound in a plurality of turns around the member;
• FIG. 51 is a view taken generally along the line of51-51 ofFIG. 50, further illustrating the relationship between the resilient member and the suture;
• FIG. 52 is a schematic illustration depicting the manner in which the resilient member ofFIGS. 50 and 51 is held in a deflected condition by the holder ofFIG. 48 to grip the suture between the holder and the resilient member;
• FIG. 53 is a sectional view illustrating another embodiment of the retainer in which an axially tapered member cooperates with an axially tapered recess in a holder to grip a suture;
• FIG. 54 is a schematic illustration of another embodiment of the retainer in which internally and externally threaded members cooperate to grip a suture;
• FIG. 55 is a schematic sectional view of another embodiment of the retainer in which fingers and recesses on a pair of members cooperate to grip a suture;
• FIG. 56 is a sectional view taken generally along the line56-56 ofFIG. 55, illustrating the manner in which a finger of one of the members cooperates to the recess on the other member to grip a suture;
• FIG. 57 is a plan view illustrating the manner in which a suture extends through another embodiment of the retainer;
• FIG. 58 is a schematic sectional view of the retainer ofFIG. 57, illustrating the manner in which a pair of cam members cooperate to grip a suture; and
• FIG. 59 (on sheet16 of drawings) illustrates a tissue fixation system used to interconnect thick and thin layers of tissue.
DESCRIPTION OF SPECIFIC PREFERRED EMBODIMENTS OF THE INVENTIONEmbodiment of FIGS.1-5
• A suture retainer50 (FIG. 1) is utilized to secure a knownsuture52 against movement relative tobody tissue54. Thesuture52 extends through anouter layer56 and aninner layer58 of the body tissue. Thesuture52 has been illustrated schematically inFIG. 1 as extending throughpassages60 and62 in the outer andinner layers56 and58 ofbody tissue54. However, thesuture52 could be sewn through the body tissue without forming thepassages60 and62 in the body tissue.
• Although thesuture52 has been shown inFIG. 1 in association with soft body tissue, it is contemplated that thesuture52 could be associated with hard body tissue. It is also contemplated that thesuture52 could extend through a suture anchor in a manner similar to that disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343.
• Thesuture52 has aleft section66 and aright section68. The left andright sections66 and68 of thesuture62 extend through the suture retainer50 (FIG. 2). If desired, thesuture52 could be integrally formed as one piece with thesuture retainer50. If this was done, an end of one of thesections66 or68 of thesuture52 would be connected with thesuture retainer50.
• Although thesections66 and68 of thesuture52 could extend straight through thesuture retainer50, it is preferred to form a plurality of bends in thesuture52. In the illustrated embodiment of the invention, twobends72 and74 (FIG. 2) are formed in theleft section66 of thesuture52. Similarly, twobends76 and78 are formed in theright section66 of thesuture52. If desired, a greater or lesser number of bends could be formed in each of thesections66 and68 of thesuture52.
• Thebends72 and74 (FIG. 2) are formed in theleft section66 of thesuture52 by wrapping aturn82 in the left section of the suture around a portion of thesuture retainer50. Similarly, thebends76 and78 are formed in theright section68 of thesuture52 by wrapping aturn84 in the right section of the suture around a portion of thesuture retainer50. Asingle loop86 is formed in theleft section66 of thesuture52 around a portion of the suture retainer. Similarly, asingle loop88 is formed in theright section68 of thesuture52 around a portion of thesuture retainer50. A greater or lesser number of loops could be provided in the left andright sections66 and68 of thesuture52 if desired.
• Thesuture retainer50 has a spherical configuration. Acylindrical passage92 extends through the center of thespherical suture retainer50. If desired, thesuture retainer50 could have a different configuration. For example, thesuture retainer50 could have an oval or elliptical configuration. Although thepassage92 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 retainer50.
• The left andright sections66 and68 of thesuture52 extend through thepassage92. In addition, the left andright sections66 and68 of thesuture52 extend around a sphericalouter side surface94 of thesuture retainer50. Thus, theloop86 in theleft section66 of thesuture52 extends around a left (as viewed inFIG. 2) hemispherical portion of thesuture retainer50. Similarly, theloop88 extends around a right hemispherical portion of thesuture retainer50.
• In the illustrated embodiment of thesuture retainer50, the left andright sections66 and68 of thesuture52 engage the smooth sphericalouter side surface94 of thesuture retainer50. However, it is contemplated that grooves could be provided in the outside of thesuture retainer50 to receive theturns82 and84 of the left andright sections66 and68 of thesuture52. Alternatively, projections could extend from the sphericalouter side surface94 of thesuture retainer50 to engage thesuture52.
• After thesuture52 has been inserted through thesuture retainer50, in the manner illustrated schematically inFIG. 2, thesuture retainer50 is moved along the left andright sections66 and68 of the suture toward the body tissue54 (FIG. 1). To move thesuture retainer50 along the left andright sections66 and68 of thesuture52, the left andright sections66 and68 of the suture are pulled upward (as viewed inFIGS. 1 and 2) to tension the sections of the suture. A downward (as viewed inFIG. 1) force is then applied against thesuture retainer50. This downward force causes thesuture retainer50 to slide in a downward direction along thesuture52 toward anupper side surface98 of the body tissue54 (FIG. 1).
• As thesuture retainer50 slides downward along the left andright sections66 and68 of thesuture52, force is applied against theleft section66 of thesuture52 at thebend74. This force causesloop86 in theleft section66 of thesuture52 to move downward (as viewed inFIG. 2) along the left section of the suture. At the same time, force is applied against theright section68 of thesuture52 at thebend78. This force causes theloop88 in theright section68 of thesuture52 to move downward along the right section of the suture.
• Thesuture retainer50 is formed as one piece of a polymeric material having a relatively low coefficient of friction. Therefore, the twosections66 and68 of thesuture52 can readily slide along theouter side surface94 and through thepassage92 in thesuture retainer50 as the suture retainer is moved downward toward the upper side surface98 (FIG. 1) of thebody tissue54.
• While a predetermined tension is maintained in the left andright sections66 and68 of thesuture52, thesuture retainer50 is pressed against theupper side surface98 of the body tissue54 (FIG. 3). This results in a connector section102 (FIG. 1) of thesuture52 being pulled tightly against theinner layer58 of body tissue. In order to obtain a desired tension in the left andright sections66 and68 andconnector section102 of thesuture52, thesuture retainer50 is pressed against theupper side surface98 of the body tissue with a predetermined force, indicated schematically by anarrow104 in theFIG. 3. Thesuture retainer50 increases the surface area on thebody tissue54 against which force is applied.
• Thus, while pulling on upper end portions of the left andright sections66 and68 of thesuture52 with a predetermined force, thesuture retainer50 is slid downward (as viewed inFIG. 1) along the left and right sections of the suture. Thesuture retainer50 is pressed against thebody tissue54 with a predetermined force104 (FIG. 3) which is sufficient to obtain a desired tension in the left andright sections66 and68 andconnector section102 of thesuture52. In this manner, a desired force, which has been preselected, is applied against thebody tissue54 by thesuture52 andsuture retainer50.
• Although thesuture retainer50 applies force against a far greater surface area on thebody tissue54 than would be engaged by a know in thesuture52, a force distribution member or button may be placed between the suture retainer and theupper surface98 of the body tissue. A second force distribution member or button may be placed between theconnector section102 of the suture and a lower side surface108 (FIG. 1) of thebody tissue54. If this is done, the main area of engagement of thesuture52 with thebody tissue54 would be at thepassages60 and62.
• In accordance with a feature of the present invention, once thesuture retainer50 has been moved along thesuture52 and is being pressed against thebody tissue54 with a predetermined force104 (FIG. 3), the suture retainer is plastically deformed to grip the left andright sections66 and68 of the suture. While thesuture retainer50 is being pressed against thebody tissue54 with thepredetermined force104 and the left andright sections66 and68 of the suture are being tensioned, a pair offorce application members112 and114 are pressed against opposite sides of thesuture retainer50. The force applied against thesuture retainer50 by theforce application members112 and114 plastically deforms the material of the suture retainer.
• The plastic deformation of thesuture retainer50 is effective to cause cold flowing of material of the suture retainer. Force indicated byarrows118 and120 inFIG. 3, is applied against thesuture retainer50 by theforce application members112 and114. This force is effective to cause flowing of the material of thesuture retainer50 at a temperature below a transition temperature range for the material of the suture retainer. Although the illustratedforce application members112 and114 have flat force transmitting surfaces, each of the force application members could have force transmitting surfaces with a configuration corresponding to the configuration of a portion of a sphere.
• The cold flowing of the material of thesuture retainer50 results in a collapsing of the passage92 (FIG. 2) and in flowing of the material of thesuture retainer50 around thesections66 and68 of thesuture52. This enables the material of thesuture retainer50 to bond to and obtain a firm grip on thesuture52. The cold flowing of the material of thesuture retainer50 occurs at a temperature which is below the transition temperature of the material forming the suture retainer.
• In the illustrated embodiment of thesuture retainer50, the material of the suture retainer flows around and grips the portion of the suture which was disposed in thepassage92. In addition, the force applied against theturns82 and84 by theforce application members112 and114 is sufficient to embed theturns82 and84 of thesuture52 in the material of thesuture retainer50 to further grip the suture. If the turns82 and84 are disposed in grooves in the outside of the suture retainer, the material of the suture retainer would more firmly grip the portion of thesuture52 forming theturns82 and84. If desired, grooves could be formed in the cylindrical side surface of thepassage92 to receive thesections66 and68 of thesuture52.
• A transducer or load cell114 (FIG. 3) is connected with theforce application member112 to measure the amount of force, indicated by thearrows118 and120, which is applied against thesuture retainer50. Adisplay unit126 is connected with theload cell124 and provides an output indicative of the force being applied against opposite sides of thesuture retainer50 by theforce application members112 and114. After a predetermined minimum force has been applied against thesuture retainer50 for a predetermined minimum time by theforce application members112 and114, an output from thedisplay unit126 activates anindicator130 to indicate to a surgeon that the desired plastic deformation of thesuture retainer50 has occurred. Theforce application members112 and114 can then be withdrawn from thesuture retainer50.
• During the time in which theforce application members112 and114 are applying the clampingforces118 and120 against opposite sides of thesuture retainer50, the suture retainer is pressed against theupper side surface98 of thebody tissue54 with a predetermined force, indicated at104 inFIG. 3. In addition, a predetermined tension is maintained insections66 and68 of thesuture52 extending upward from thesuture retainer50. Upon disengagement of theforce application members112 and114 from thesuture retainer50, the application of the downward (as viewed inFIG. 3)force104 against thesuture retainer50 is interrupted. The upward tensioning of thesections66 and68 of thesuture52 is also interrupted.
• The application of the clampingforces118 and120 against opposite sides of thesuture retainer50 causes cold flowing of the material of the suture retainer. As this occurs, the material of thesuture retainer50 moves between and extends around the portions of the left andright sections66 and68 of thesuture52 disposed in the passage92 (FIG. 2). Thus, a portion134 (FIGS. 2 and 4) and aportion136 of theleft section66 of thesuture52 are fully enclosed by the material of thesuture retainer50. A cold bonding of the material of thesuture retainer50 with the exterior surfaces of theportions134136 of theleft section66 of the suture retainer securely interconnects the material of the suture retainer and thesuture52.
• Similarly, theportions138 and140 of theright section68 of thesuture52 disposed in the passage92 (FIG. 2) are surrounded by and bonded with the material of the suture retainer50 (FIG. 4). The manner in which the material of thesuture retainer50 extends completely around and is connected with the length orportion138 of theright section68 of thesuture52 is illustrated schematically inFIG. 5. It should be understood that the permanent deformation of the material of thesuture retainer50 occurs as a result of compression of the material of the suture retainer while the material is at a temperature close to the temperature of thebody tissue54. This temperature is below the transition temperature for the material of thesuture retainer50.
• Once thesuture retainer50 has been plastically deformed to securely grip thesuture52, the suture may be knotted if desired. Thus, a knot may be formed between the portions of thesections66 and68 of thesuture52 which extend upward (as viewed inFIGS. 1-3) from theretainer50. Such a knot would provide additional protection against the suture working loose under the influence of varying loads over an extended period of time. Since thesuture retainer50 is disposed between the knot and thebody tissue54, the knot will not reduce the overall force transmitting capability of thesuture52. However, it is believed that forming a knot in thesections66 and68 of thesuture52 adjacent to the upper end of thesuture retainer50 will not be necessary.
• Thesuture retainer50 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer50 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer50 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 retainer50 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, the suture retainer could be formed of an acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer50 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• It is preferred to effect the cold flowing of the material of thesuture retainer50 without the addition of heat. However, it is contemplated that thesuture retainer50 could be heated to a temperature which is somewhat above the temperature of thebody tissue54. If desired, heat could be transmitted to thesuture retainer50 through theforce application members112 and114 (FIG. 3). Although thesuture retainer50 may be heated, the suture retainer would be maintained at a temperature below the transition temperature for the material of the suture retainer.
• In the illustrated embodiment of the invention, thesuture52 is separate from thesuture retainer50. However, one of thesections66 or68 of thesuture52 could be fixedly connected with thesuture retainer50. This could be accomplished with a suitable fastener or by forming thesuture52 integrally as one piece with the suture retainer. This would result in thesuture retainer50 sliding along only one of thesections66 or68 of thesuture52.
• Thesuture52 may be formed of natural or synthetic materials. Thesuture52 may be a monofilament or may be formed of a plurality of interconnected filaments. Thesuture52 may be biodegradable or nonbiodegradable. It may be preferred to form thesuture52 of the same material as thesuture retainer50. However, thesuture52 could be formed of a material which is different than the material of the suture retainer.
• The use of thesuture retainer50 eliminates the necessity of forming a knot in thesuture52. By eliminating the formation of a knot in thesuture52, the overall force transmitting capability of the suture is increased. In addition to increasing the overall force transmitting capability of thesuture52, thesuture retainer50 increases the surface area on the body tissue54 (FIG. 1) against which force is applied by the suture. This tends to minimize any tendency for thesuture52 to cut or separate the body tissue.
• It is believed that it may be preferred to position the left andright sections66 and68 of thesuture52 relative to the body tissue54 (FIG. 1) before winding the two sections of the suture around thesuture retainer50. However, one of thesections66 or68 of thesuture52 may be wound around thesuture retainer50 before the suture is positioned in thepassages60 and62 in thebody tissue54. For example, theleft section66 of thesuture52 may e wound around thesuture retainer52 to form thebends72 and74 and the loop86 (FIG. 2) while the suture is spaced from thebody tissue54. Theright section68 of the suture is then inserted through thepassages60 and62 (FIG. 1) in thebody tissue54. Theright section68 of thesuture52 is then wound around thesuture retainer50 to form thebends76 and78 and loop88 (FIG. 2).
Embodiment of FIGS.6-8
• In the embodiment of the invention illustrated inFIGS. 1-5,complete loops86 and88 are formed in thesections66 and68 of thesuture52. In the embodiment of the invention illustrated inFIGS. 6-8, partial loops are formed in each of the sections of the suture. Since the embodiment of the invention illustrated inFIGS. 6-8 is similar to the embodiment of the invention illustrated inFIGS. 1-5, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiment of the invention illustrated inFIGS. 1-5 may be used with the embodiment of the invention illustrated inFIGS. 6-8.
• Asuture retainer150 is utilized to secure asuture52 against movement relative to body tissue. Thesuture52 hassections66 and68 which engage body tissue in the same manner as previously described in conjunction with the embodiment of the invention illustrated inFIGS. 1-5. Although thesuture52 is illustrated inFIG. 1 in association with soft body tissue, it is contemplated that thesuture52 could be utilized in association with hard body tissue and/or one or more suture anchors.
• Thesuture retainer150 includes a rectangular base orbody section152 and a movable post or lockingsection154. The post or lockingsection154 is integrally formed as one piece with thebase152. The post or locking section is hingedly connected with the base152 at aconnection156. Thepost154 is pivotal relative to the base at theconnection156 in the manner indicated schematically by the arrow158 inFIG. 6.
• Thebase152 has acentral groove162 which is aligned with thepost154. Thegroove162 has a rectangular cross sectional configuration. Thegroove162 has a cross sectional area which is greater than the cross sectional area of thepost154. In the illustrated embodiment of thesuture retainer150, thepost154 and groove162 both have a rectangular cross sectional configuration. However, the post and groove could have a different cross sectional configuration if desired. For example, thepost154 and groove162 could have a semi-circular cross sectional configuration.
• Thebase152 has a pair of flat rectangular upper (as viewed inFIGS. 6 and 7) side surfaces166 and168. The flat side surfaces166 and168 extend in opposite directions from thegroove162 and extend parallel to a flat rectangularbottom surface170. Thesuture retainer150 is formed from a single piece of a biodegradable polymer, such as polycaperlactone. Of course, other biodegradable or bioerodible copolymers could be utilized to form thesuture retainer150. It is contemplated that thesuture retainer150 may be formed of materials which are not biodegradable.
• When thesuture retainer150 is to be utilized to hold thesections66 and68 of thesuture52 against movement relative to body tissue, thepost154 is pivoted from its initial or extended position, shown inFIG. 6, to its engaged or locking position, shown inFIG. 7. As thepost154 is pivoted to the engaged position ofFIG. 7, aflat side surface174 of the post is pressed against thesections66 and68 of the suture to force the sections into thegroove162. The post is effective to clamp or hold thesections66 and68 of thesuture52 against movement relative to the base152 upon movement of the post to the engaged position shown inFIG. 7.
• Once thepost154 has been moved to the engaged position shown inFIG. 7, thebase152 is bent from the flat orientation ofFIGS. 6 and 7 to the folded orientation ofFIG. 8. Once thebase152 has been folded, a pair of force,application members112 and114 engage opposite sides of the bottom orouter surface170 of the base. Theforce application members112 and114 are then pressed toward each other, in the manner indicated schematically by thearrows118 and120 inFIG. 8, to apply pressure against thesuture retainer150.
• At this time, thesuture retainer150 is at a temperature below the transition temperature of the material forming the suture retainer. Thus, thesuture retainer150 is at a temperature which is approximately the same as the temperature of the body tissue relative to which thesuture retainer150 is being utilized to secure thesuture52. The force applied against thesuture retainer150 by theforce application members112 and114 plastically deforms the material of the suture retainer. This results in a cold flowing of the material of thesuture retainer150 under the influence of the force applied against the suture retainer by theforce application members112 and114.
• A transducer orload cell124 measures theforce118 and120 applied against thebase152 of thesuture retainer150. Theload cell124 provides an output signal to adisplay unit126. The output signal provided by thetransducer124 corresponds to the magnitude of the force applied against opposite sides of thesuture retainer150 by themembers112 and114.
• After a predetermined minimum force has been applied against opposite sides of thesuture retainer150 for a sufficient period of time to effect a cold flowing of the material of the suture retainer, an output signal from thedisplay unit126 activates anindicator130. The output from theindicator130 indicates to a surgeon and/or other medical personnel that the force has been applied against opposite sides of thesuture retainer150 by theforce application members112 and114 for a period of time sufficient to cause cold-flowing of the material of the suture retainer. The cold flowing of the material of thesuture retainer150 results in a secure interconnection between the material of thesuture retainer150 and thesections66 and68 of thesuture52.
• In the embodiment of the invention illustrated inFIGS. 6-8, thesuture52 is separate from thesuture retainer150. However, thesuture52 could be fixedly connected to or integrally formed as one piece with thesuture retainer150. For example, thebase152 could be integrally formed with thesection66 of thesuture52 if desired.
Embodiment of FIGS.9-12
• In the embodiment of the invention illustrated inFIGS. 1-5, thesections66 and68 of thesuture52 extend through a passage formed in aspherical suture retainer50. In the embodiment of the invention illustrated inFIGS. 9-12, the sections of the suture extend along a groove formed in the outside of a suture retainer. Since the embodiment of the invention illustrated inFIGS. 9-12 is similar to the embodiment of the invention illustrated inFIGS. 1-5, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-8 may be used with the embodiment of the invention illustrated inFIGS. 9-12.
• A suture retainer180 (FIG. 9) is utilized to secure asuture52 against movement relative tobody tissue54. Although thebody tissue54 is soft body tissue, it is contemplated that thesuture retainer180 could be utilized to secure thesuture52 against movement relative to hard body tissue, such as bone. Thesuture retainer180 may be used either with or without a suture anchor.
• Thesuture retainer180 has a cylindrical main section orbody184. Thebody184 has a cylindricalouter side surface186. Flat circular end surfaces188 and190 extend perpendicular to a longitudinal central axis of thecylindrical side surface186. In the illustrated embodiment of thesuture retainer180, thebody184 is cylindrical and has a linear longitudinal central axis. If desired, thebody184 could be rectangular and/or have a nonlinear longitudinal central axis.
• Ahelical groove194 is formed in thebody184. Thehelical groove194 has a constant pitch. Therefore, turns of thegroove194 are equally spaced. However, if desired, the pitch of the turns of thegroove194 could vary along the length of thebody184.
• Thehelical groove194 has a central axis which is coincident with the central axis of thebody184 and cylindricalouter side surface186 of thesuture retainer180. A radially inner portion of thehelical groove194 defines a right circular cylinder which is coaxial with theouter side surface186 of thebody184. However, the radially inner portion of thehelical groove194 could define a right circular cone or other configuration if desired.
• The left andright sections66 and68 of thesuture52 extend through thegroove194 and aroundbody tissue54. It is believed that it will be advantageous to provide thehelical groove194 with retainers orbridge sections198 and200 which extend across the open ends of the helical groove. Thebridge sections198 and200 are integrally formed as one piece with thebody184. Thebridge sections198 and200 prevent thesections66 and68 of thesuture52 from pulling out of thehelical groove194 during positioning of thesuture retainer180 in a human patient's body. However, thebridge sections198 and200 may be omitted if desired.
• Thehelical groove194 has a generally U-shaped cross sectional configuration (FIG. 10). Thus, thehelical groove194 has an open mouth orentrance204. A pair of side surfaces206 and208 slope radially inward and axially upward (as viewed inFIGS. 9 and 10) from theentrance204. Anarcuate bottom surface210 of thegroove194 extends between the side surfaces206 and208.
• Thesection66 of thesuture52 is disposed in engagement with thebottom surface210 of thehelical groove194. Thesection68 of thesuture52 is disposed in engagement with thesection66 of the suture (FIG. 10). If desired, the size of thearcuate bottom surface210 of thegroove194 could be increased to enable bothsections66 and68 of thesuture52 to engage the bottom surface.
• Thegroove194 may be provided with a configuration similar to the configuration shown inFIG. 11. Thus, inFIG. 11, the side surfaces206 and208 of thehelical groove194 extend inward from theopen entrance204 to anarcuate bottom surface210 which forms a major portion of a circle. Thebottom surface210 ofFIG. 11 defines arecess214 in which the twosections66 and68 of the suture are disposed. It is believed that thebridge sections198 and200 will probably be omitted with the embodiment of thegroove194 illustrated inFIG. 11.
• Thecylindrical body184 of thesuture retainer180 is molded from a single piece of a biodegradable polymer. For example, thebody184 of thesuture retainer180 may be molded from polycaperlactone. Alternatively, thebody184 of thesuture retainer180 could be molded of polyethylene oxide terephthalate or polybutylene terephthalate. Of course, thebody184 of thesuture retainer180 could be molded as one piece of other biodegradable or bioerodible copolymers if desired. Although it is preferred to form thebody184 of biodegradable materials, the body could be formed of materials which are not biodegradable. For example, thebody184 could be formed of “Delrin” (trademark).
• The left andright sections66 and68 (FIG. 9) of thesuture52 are inserted into thehelical groove194 in thebody184 of thesuture retainer180. At this time, thebody184 of thesuture retainer180 is spaced from thebody tissue54. It is believed that insertion of the left andright sections66 and68 of thesuture52 into thehelical groove194 will be facilitated if thebridge sections198 and200 are omitted. However, if thebridge sections198 and200 are omitted, difficulty may be encountered in maintaining thesections66 and68 of thesuture52 in thehelical groove194.
• As the left andright sections66 and68 of thesuture52 are inserted into the helical groove194 (FIG. 9), the sections of the suture are wrapped around thebody184 of thesuture retainer180. As this occurs, a plurality of helical loops are formed in the left andright sections66 and68 of thesuture52. Once thesuture52 has been inserted into thehelical groove194, a plurality of circular turns are maintained in the left andright sections66 and68 of thesuture52 by thehelical groove194. Therefore, a continuous series of smooth arcuate bends, which are free of stress inducing discontinuities, is maintained in thesuture52 by thehelical groove194.
• After thesuture52 has been inserted into thehelical groove194, thesuture retainer180 is moved along the suture toward the body tissue54 (FIG. 9). During this movement of thesuture retainer180 along thesuture52, the left andright sections66 and68 of the suture are tensioned. The radially inward and axially upward sloping configuration of the helical groove194 (FIGS. 10 and 11) results in the left andright sections66 and68 of the suture being pulled toward thearcuate bottom surface210 of the groove. This results in thebody184 of thesuture retainer180 maintaining the helical loops in the left andright sections66 and68 of thesuture52 as thesuture retainer180 moves toward thebody tissue54.
• As thesuture retainer180 moves toward the body tissue54 (FIG. 9), the left and/orright sections66 and68 of thesuture52 slide along the arcuate bottom surface210 (FIG. 10) of thegroove194. Thegroove194 imparts a helical configuration to the portion of thesuture52 disposed in the groove. As thebody184 of thesuture retainer180 moves downward toward thebody tissue54, the portion of thesuture52 having a helical configuration moves downward toward the body tissue.
• As thesuture retainer180 is slid along the tensionedsections66 and68 of thesuture52, the tensioning force in the suture pulls the suture toward thebottom surface210 of thehelical groove194. The biodegradable copolymer forming thebody184 of thesuture retainer180 has a low coefficient of friction. This minimizes theforce220 required to move the suture retainer along the left andright sections66 and68 of thesuture52 toward thebody tissue54.
• Thesuture retainer180 is moved along the taut left andright sections66 and68 of thesuture52 until theleading end surface190 of thebody184 of thesuture retainer180 engages the body tissue54 (FIG. 9). Theforce220 is then increased to a predetermined magnitude while maintaining a predetermined tension in the left andright sections66 and68 of thesuture52. This results in thesuture52 being pulled tightly around the body tissue and exerting a predetermined force against the body tissue.
• It is contemplated that the magnitude of the force220 (FIG. 9) with which thesuture retainer190 is pressed against thebody tissue54 will be measured to be certain that the force has a desired magnitude. Theforce220 may be measured with a suitable transducer, such as a load cell or a force measuring device having a spring which is compressed to a predetermined extent by the application of the desired force against thebody tissue54. Rather than engaging thebody tissue54 directly with theleading end surface190 of thesuture retainer180, a suitable force transmitting member, such a button, could be provided between the suture retainer and the body tissue.
• While thesuture retainer180 is being pressed against thebody tissue54 with thepredetermined force220 and thesections66 and68 of thesuture52 are being tensioned with a predetermined force, the left andright sections66 and68 of thesuture52 are gripped by plastically deforming the material of the suture retainer. To plastically deform the material of the suture retainer, a plurality offorce application members224,226 and228 (FIG. 12) are pressed against the cylindricalouter side surface186 of thesuture retainer180. Since theouter side surface186 of thesuture retainer180 has a cylindrical configuration, theforce application members224,226 and228 have an arcuate configuration and are formed as portions of a circle. However, theforce application members224,226 and228 could have the flat configuration of theforce application members112 and114 ofFIG. 3.
• Theforce application members224,226 and228 are pressed against theouter side surface186 of thesuture retainer180 with a predetermined force, indicated by thearrows232 inFIG. 12. This force has a magnitude and is applied for a length of time sufficient to cause cold flowing of the material of thebody184 of thesuture retainer180. The plastic deformation of the material of thebody194 of thesuture retainer180 results in thehelical groove194 being collapsed and the material of the suture retainer being pressed against the left andright sections66 and68 of thesuture52. The resulting cold bonding of the material of thesuture retainer180 with the left andright sections66 and68 of thesuture52 secures in the suture retainer against movement relative to the suture.
• The cold flowing of the material of thebody184 of thesuture retainer180 occurs with the body of the suture retainer at substantially the same temperature as the temperature of the body tissue54 (FIG. 9). Thus, the cold flowing of the material of thebody184 of thesuture retainer180 occurs at a temperature below the transition temperature of the material forming thebody184 of thesuture retainer180. However, if desired, some heat may be added to thebody184 to facilitate plastic deformation of the body of thesuture retainer180.
• Thesuture retainer180 eliminates the necessity of forming a knot in thesuture52. The formation of a knot in thesuture52 would cause a stress concentration in the suture and would decrease the overall force transmitting capability of the suture. By eliminating the knot, the overall force transmitting capability of thesuture52 is increased. However, if desired, a knot could be formed in thesections66 and68 of thesuture52 at a location above (as viewed inFIG. 1) thesuture retainer180. Since thesuture retainer180 would be disposed between this knot and thebody tissue54, the knot would not decrease the overall force transmitting capability of thesuture52.
• In the embodiment of the invention illustrated inFIGS. 9-12, a singlehelical groove194 is formed in thebody184 of thesuture retainer180. It is contemplated that a pair of spaced apart helical grooves could be formed in thebody184 of thesuture retainer180. If this was done, the two helical grooves would be wrapped in the same direction around thebody184 of thesuture retainer180 and would be offset from each other by180N about the circumference of the cylindrical body of the suture retainer. Theleft section66 of thesuture52 would be disposed in one of the helical grooves and theright section68 of the suture would be disposed in the other helical groove.
• By having a pair of spaced apart helical grooves in thebody184 of thesuture retainer180, in the manner set forth in the preceding paragraph, the left andright sections66 and68 of thesuture52 would exit from the lower (as viewed inFIG. 9 end of the suture retainer at diametrically opposite locations on thecircular end surface190. This embodiment of thesuture retainer180 would have the advantage of having a relatively large area of engagement with thebody tissue54. Thus, the tension in the suture would press the flatcircular end surface190 on the suture retainer against the body tissue.
• In the illustrated embodiment of the invention, thesuture52 is separate from thesuture retainer180. However, if desired, thesuture52 could be fixedly connected with or integrally formed as one piece with the suture retainer. For example, theleft section66 of thesuture52 could be fixedly connected with thebody184 of thesuture retainer180 by a suitable fastener. If this was done, only theright section68 of thesuture52 would be received in thegroove194.
Embodiment of FIGS.13-16
• In the embodiment of the invention illustrated inFIGS. 9-12, the left andright sections66 and68 of thesuture52 are wrapped in the same direction around thecylindrical body184 of thesuture retainer180. In the embodiment of the invention illustrated inFIGS. 13-16, the sections of the suture are wrapped in opposite directions around a conical body of a suture retainer. Since the embodiment of the invention illustrated inFIGS. 13-16 is similar to the embodiment of the invention illustrated inFIGS. 9-12, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-12 may be used with the embodiments of the invention illustrated inFIGS. 13-16.
• A suture52 (FIG. 13) has left andright sections66 and68 which are wrapped in opposite directions around aconical body242 of asuture retainer244. Thus, as viewed from above, theleft section66 of thesuture52 is wrapped in a counterclockwise direction around thebody242 of thesuture retainer244. Theright section68 of thesuture52 is wrapped in a clockwise direction around thebody242 of thesuture retainer244.
• The left andright sections66 and68 of thesuture52 are wrapped for approximately 1½ turns around thebody242 of thesuture retainer244. Therefore, theleft section66 of thesuture52 moves from the left side of the upper end (as viewed inFIG. 13) of thebody242 of thesuture retainer244 to the right side of the lower end of the body of the suture retainer. Similarly, theright section68 of thesuture52 moves from the upper right side of thebody242 of thesuture retainer244 to the lower left side of the body of the suture retainer.
• If the twosections66 and68 of thesuture52 were wrapped around thebody242 of thesuture retainer244 for complete turns, the sections of the suture would be on the same side of thebody242 at the top and bottom of the suture retainer. For example, if thesuture52 was wrapped two complete turns around thebody242, theleft section66 of thesuture52 would be disposed at the left side of both the upper and lower ends of thebody242. Similarly, theright section68 of thesuture52 could be disposed at the right side of both the upper and lower ends of thebody242 of the suture retainer.
• Thebody242 of thesuture retainer244 is formed as a portion of a right circular cone. Thebody242 of thesuture retainer244 has anouter side surface248 with an axially downward (as viewed inFIG. 13) and radially inward tapering configuration. Theconical body242 of thesuture retainer244 has parallel circular end surfaces252 and254 which extend perpendicular to a longitudinal central axis of the conical body. The circular end surfaces252 and254 are disposed in a coaxial relationship. Theupper end surface252 has a larger diameter than thelower end surface254.
• A pair ofhelical grooves258 and260 (FIGS. 13-16) are formed in theconical body242. Thehelical grooves258 and260 have a spiral configuration with a central axis which is coincident with the central axis of theconical body242. Thus, the diameter of the turns of thegrooves258 and260 progressively decreases as the grooves extend downward (as viewed inFIG. 13) from theupper end surface252 to thelower end surface254. Thehelical grooves258 and260 have the same pitch.
• Thehelical grooves258 and260 are wrapped in opposite directions around theconical body242 of thesuture retainer244. Thus, as viewed from above, thehelical groove258 is wrapped in a counterclockwise direction around thebody242 of thesuture retainer244. Thehelical groove260 is wrapped in a clockwise direction around thebody242 of thesuture retainer244.
• Thehelical grooves258 and260 are offset by180N. Thus, thehelical groove258 beings at the upper left (as viewed inFIG. 13) side of thebody242 and thehelical groove260 begins at the upper right side of thebody242. The entrances to thehelical grooves258 and260 are disposed at diametrically offset locations on the circularupper end surface252 of thebody242. Thehelical groove258 ends at the lower right (as viewed inFIG. 13) side of thebody242. Thehelical groove260 ends at the lower left side of thebody242. The exits from thehelical grooves258 and260 are disposed at diametrically offset locations on the circularlower end surface254 of thebody242. This results in the relatively largelower end surface254 o f thebody242 being disposed between the left andright sections66 and68 of thesuture52 and exposed to body tissue.
• Thegroove258 has an axially upward and radially inward sloping configuration (FIG. 14). Thegroove258 has a helical open mouth orentrance264. Thegroove258 has a pair of axially upward and radially inward sloping side surfaces266 and268. The side surfaces266 and268 are interconnected by anarcuate bottom surface270. Thegroove258 has the same depth and cross sectional configuration throughout the extent of the groove.
• Although only thegroove258 is illustrated inFIG. 14, it should be understood that thegroove260 has the same cross sectional configuration as thegroove258. The twogrooves258 and260 extend between the opposite end surfaces252 and254 of theconical body242. It is contemplated that thegrooves258 and260 could have a different cross sectional configuration if desired. For example, thegrooves258 and260 could have the cross sectional configuration shown inFIG. 11 if desired.
• Thegrooves258 and260 intersect on opposite sides of theconical body242 in the manner illustrated inFIGS. 15 and 16. At the intersections between thegrooves258 and260, the left andright sections66 and68 of thesuture52 overlap (FIG. 16). The number of intersections ofgrooves258 and260 will vary as a direct function of the number of turns of thegrooves258 and260 around thebody242.
• Bridge sections274 and276 (FIG. 13) are provided across opposite ends of thegroove258 to facilitate in retaining thesuture section66 in the groove. Similarly,bridge sections278 and280 are provided across opposite ends of thegroove260 to facilitate in retaining thesuture section68 in thegroove260. If desired, thebridge sections274,276,278 and280 could be omitted.
• In addition to theconical body242, thesuture retainer244 includes a cylindrical sleeve284 (FIG. 13). Thetubular sleeve284 has a cylindricalouter side surface286 and a conicalinner side surface288. The inner and outer side surfaces286 and288 are disposed in coaxial relationship. The conicalinner side surface288 of thesleeve284 tapers axially inward and downward (as viewed inFIG. 13) at the same angle as does the conicalouter side surface248 of thebody242.
• Although the conicalinner side surface288 of thesleeve284 has been schematically illustrated inFIG. 13 as having an inside diameter which is greater than the outside diameter of theconical body242, it is contemplated that theconical body242 will have substantially the same diameter as theinner side surface288 of thesleeve284. Therefore, when thecircular end surface252 on theconical body242 is axially aligned with anannular end surface292 on the sleeve284 (as shown inFIG. 13), theouter side surface248 on theconical body242 will be disposed in abutting engagement with theinner side surface288 on thesleeve286. Of course, if the conicalinner side surface288 of thesleeve284 has a larger diameter than the conicalouter side surface248 of thebody242, axially downward (as viewed inFIG. 13) movement of theconical body242 relative to thesleeve284 will result in abutting engagement between theinner side surface288 of the sleeve and theouter side surface248 of the conical body.
• Theconical body242 and thesleeve284 are both formed of a biodegradable polymer, such as polycaperlactone. However, theconical body242 and thesleeve284 could be formed of polyethylene oxide terephthalate or polybutylene terephthalate if desired. Other biodegradable or bioerodible copolymers could be utilized if desired. It is contemplated that it may be desired to form theconical body242 andsleeve284 of a polymer which is not biodegradable. Theconical body242 andsleeve284 could be formed of two different materials if desired.
• When thesuture retainer244 is to be positioned in a human patient's body, the left andright sections66 and68 of the suture are first inserted through the open center of thesleeve284. Thesections66 and68 of thesuture52 are then wrapped around theconical body242 in thegrooves258 and260. Thesleeve284 may then be moved along thesuture252 to the desired position in a patient's body.
• It is believed that it will be preferred to position the left andright sections66 and68 of thesuture52 relative to the body tissue before winding the two sections of the suture around thebody242. However, one of thesections66 or68 of thesuture52 may be wound around thebody242 and inserted through thesleeve284 before the suture is positioned relative to the body tissue. After thesuture52 has been positioned relative to the body tissue, the other section of the suture would be inserted through thesleeve284 and wound around thebody242.
• When thesuture52 has been positioned relative to the body tissue andsuture retainer244, thesections66 and68 of thesuture52 are tensioned as a force296 (FIG. 13) is applied to theconical body242. Theforce296 is sufficient to cause theconical body242 of thesuture retainer244 to slide axially along thesections66 and68 of the suture toward thesleeve284. As this occurs, theouter side surface248 on theconical body242 moves into engagement with theinner side surface288 on thesleeve284. Theforce296 is then effective to press theouter side surface248 on theconical body242 firmly against theinner side surface288 of the sleeve.
• Theforce296 is also effective to press both theend surface254 of theconical body242 and anannular end surface300 of thesleeve284 against the body tissue. While the let andright sections66 and68 of the suture are tensioned, theforce296 is increased. After thesuture retainer244 has been pressed against the body tissue with apredetermined force296 sufficient to cause thesuture52 to grip the body tissue with a desired tension, force applicator members, similar to theforce applicator members224,226 and228 ofFIG. 12, compress thesleeve284. The manner in which force is applied against thesleeve284 is indicated schematically byarrows302 and304 inFIG. 13. If desired, one or more axial slot may be provided through a portion of thesleeve284 to facilitate compression of the sleeve.
• The force applied against thesleeve284, indicated schematically at302 and304, causes radially inward plastic deformation of the sleeve. This force is transmitted through the sleeve to theconical body242. The force transmitted to theconical body242 causes a collapsing of thegrooves258 and260. As thegrooves258 and260 collapse, the material of theconical body242 is plastically deformed and firmly grips or bonds to the outer side surfaces of the left andright sections66 and68 of thesuture52. Thesleeve284 bonds to the material of theconical body242.
• Thesleeve284 andconical body242 of thesuture retainer244 are at a temperature below the transition temperature of the material forming the sleeve and conical body when they are compressed by the force indicated schematically at302 and304 inFIG. 13. This results in cold flowing of the material of both thesleeve284 and thesuture retainer244 under the influence of theforce302 and304. Theforce302 and304 is maintained at a predetermined magnitude for a time sufficient to result in cold plastic deformation of the material of thesleeve284 andconical body242. This plastic deformation or cold flow of the material of thesleeve284 andconical body242 occurs at a temperature which is substantially the same as the temperature of the body tissue with which thesuture52 is connected.
• If desired, cold flowing of the material of thesleeve284 andconical body244 could be promoted by the addition of heat. Thus, thesleeve284 andconical body244 may be preheated before being moved into engagement with the body tissue. If desired, heat could be transmitted to thesleeve284 andconical body242 during application of he force302 and304. During the application of theforce302 and304 to thesleeve284, both theconical body242 andsleeve284 are at a temperature below the transition temperature of the material of the conical body and sleeve.
• Once thesuture retainer284 has been plastically deformed to securely grip thesuture52, the suture may be knotted. Thus, a knot may be formed in the upper (as viewed inFIG. 13)end portions66 and68 ofsuture52. The knot would pull thesections66 and68 of the suture firmly against theupper side surface252 of theconical body242. This knot would not decrease the overall force transmitting capability of thesuture52 since thesuture retainer244 would be disposed between the knot and the body tissue. Although such a knot would provide additional assurance that the suture will not work loose, it is believed that the knot is not necessary.
• The tension in thesuture52 will press theannular end surface300 on thesleeve284 and thecircular end surface254 on theconical body242 against the body tissue. Due to the relative large combined area of the end surfaces254 and300, the tension forces in thesuture52 will be applied to a relatively large area on the body tissue by thesuture retainer244. Since thesuture retainer244 applies force to a relatively large surface area on the body tissue and since the overall strength of thesuture52 is not impaired by thesuture retainer244, relatively large forces can be transmitted through the suture to the body tissue.
• In the embodiment of the invention illustrated inFIGS. 13-16, thehelical grooves258 and260 cross. This results in the left andright sections66 and68 of thesuture52 being disposed in overlapping engagement at the intersections between thegrooves258 and260. The overlapping engagement of the left andright sections66 and68 of thesuture52 increases the resistance of thesuture retainer244 to slipping of one section of the suture relative to the other section of the suture.
Embodiments of FIGS.17-19
• In the embodiment of the invention illustrated inFIGS. 13-16, the central axis of theconical body242 of thesuture retainer244 extends along thesections66 and68 of thesuture52. In the embodiments of the invention illustrated inFIGS. 17-19, a central axis of a circular body of the suture retainer extends transverse to the longitudinal axis of the suture during movement of the suture retainer toward the body tissue. Since the suture retainer of the embodiments of the invention illustrated inFIGS. 17-19 is similar to the suture retainer of the embodiment of the invention illustrated inFIGS. 13-16, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-16 may be used with the embodiments of the invention illustrated inFIGS. 17-19.
• A suture retainer312 (FIGS. 17 and 18) includes acylindrical housing314 and arotatable cylinder316. Thehousing314 encloses therotatable cylinder316. Therotatable cylinder316 has a central axis which is coincident with the central axis of thecylindrical housing314.
• Thecylinder316 is supported for rotation relative to thehousing314 by bearingsections320 and322 (FIG. 17). The bearingsections320 and322 are integrally formed as one piece with thehousing314. The bearingsections320 and322 have a conical configuration and engage conical recesses formed in opposite ends of therotatable cylinder316. The bearingsections320 and322 support thecylinder316 in a coaxial relationship with thehousing314.
• Left andright sections66 and68 of thesuture52 extend into thehousing314 throughcylindrical openings326 and328. Thesections66 and68 of thesuture52 extend from thehousing314 throughopenings330 and332. Theopenings326,328,330 and332 have parallel central axes which extend tangentially to thecylinder316.
• Theleft section66 of thesuture52 extends through theopening326 into thehousing314. Theleft section66 of thesuture52 is wrapped in a clockwise direction (as viewed inFIG. 18) around thecylinder316 and extends from thehousing314 through theopening330. Similarly, the right section68 (FIG. 17) of thesuture52 extends into thehousing314 through theopening328. Theright section68 of thesuture52 is wrapped in a counterclockwise direction, as viewed inFIG. 18, around thecylinder316. The turns in the left andright sections66 and68 in thesuture52 are axially spaced apart along the cylindrical outer side surface of thecylinder316. If desired, helical grooves may be provided in thecylinder316 to receive the turns of the left andright sections66 and68 of the suture.
• Thecylindrical housing314 is formed of a biodegradable polymeric material. Thecylinder316 is also formed of a biodegradable polymeric material. However, the material of thecylinder316 is harder than the material of thehousing314. The material of thecylinder316 has a lower coefficient of friction than the material of thehousing314. The material of thehousing314 is easier to plastically deform than the material of thecylinder316. Of course, the housing andcylinder314 and316 may be formed of the same material which may be biodegradable (polycaperlactone) or may not be biodegradable.
• When thesuture retainer312 is to be positioned relative to body tissue (not shown), the left andright sections66 and68 of the suture are tensioned. Thehousing312 is then pushed downward (as viewed inFIGS. 17 and 18) in the manner indicated schematically by anarrow336 inFIG. 18. As this occurs, the turns or wraps of thesections66 and68 of the suture slide along a cylindrical outer side surface of therotatable cylinder316. The oppositely wound loops in thesections66 and68 of thesuture52 move downward along the suture toward the body tissue as theretainer312 moves downward along the suture toward the body tissue.
• Although there will be some rotational movement of thecylinder316 relative to thehousing314, the position of thecylinder316 relative to thehousing314 remains substantially constant during a major portion of the movement of thesuture retainer312 along thesuture52 toward the body tissue. This is because the left andright sections66 and68 of the suture are wrapped in opposite directions around thecylinder316. This results in the portion of the loop in theleft section66 of the suture tending to rotate thecylinder316 in a counterclockwise direction (as viewed inFIG. 18). At the same time, the loop formed in theright section68 of thesuture52 tends to rotate thecylinder316 in a clockwise direction (as viewed inFIG. 18).
• Since the twosections66 and68 of thesuture52 tend to urge thecylinder316 to rotate in opposite directions, the cylinder tends to remain more or less stationary relative to thehousing314. The loops in the left andright sections66 and68 of thesuture52 slide along the cylindrical outer side surface of thecylinder316. However, it should be understood that there will be some rotational movement of thecylinder316 relative to thehousing314 as thesuture retainer312 is moved toward the body tissue.
• Once thehousing314 of thesuture retainer312 is moved into engagement with the body tissue, the tension is maintained in thesections66 and68 of thesuture52. The force336 (FIG. 18) pressing thesuture retainer312 against the body tissue is increased. Thesuture retainer312 is pressed against the body tissue with a force, indicated schematically by thearrow336 inFIG. 18, which is sufficient to provide a desired tension in the portion of thesuture52 engaging the body tissue.
• The material of thesuture retainer312 is then plastically deformed. The plastic deformation of thesuture retainer312 is accomplished by applying force against opposite sides of thehousing314 with a pair offorce application members340 and342 (FIG. 18). The force applied against thesuture retainer312 by theforce application members340 and342 presses the material of thehousing314 against thesections66 and68 of the suture and thecylinder316 by cold flowing material of the housing.
• A large gap has been shown between the cylindrical outer side surface of thecylinder316 and a cylindrical inner side surface of thehousing314 inFIG. 18. However, it should be understood that this annular gap will be relatively small so that the material of thehousing314 can readily cold flow into engagement with the turns of thesections66 and68 of thesuture52 andcylinder316. The force applied against thehousing314 also plastically deforms and causes cold flowing of the material of thecylinder316 to provide a secure bond or grip between the material of thecylinder316 and thesuture52.
• A transducer orload cell346 is associated with theforce application member342 and provides an output to adisplay unit348. After a predetermined minimum force has been applied to thesuture retainer312 by theforce application members340 and342 for a predetermined minimum length of time, an output from thedisplay unit348 to anindicator350 activates the indicator to provide a signal that the desired plastic deformation of thesuture retainer312 has been obtained.
• If desired, a knot may be tied between the left andright sections66 and68 of thesuture52 adjacent to a side of thehousing314 opposite from a side of the housing which is pressed against the body tissue by the suture. The knot would be pulled tight against the housing at a location between theopenings326 and328. Since thesuture retainer312 is between the knot and the body tissue, the knot would not impair the force transmitting capability of thesuture52.
• InFIGS. 17 and 18, thesections66 and68 of thesuture52 are wrapped in opposite directions around thecylinder316. This results in offsetting forces being applied to thecylinder316 by the turns in thesections66 and68 of thesuture52 during movement of thesuture retainer312 along the suture toward the body tissue. InFIG. 19, the left andright sections66 and68 of thesuture52 are wrapped in the same direction around thecylinder316. This results in the turns or loops in thesections66 and68 of thesuture52 applying force to thecylinder316 urging the cylinder to rotate in the same direction during movement of thesuture retainer312 along thesections66 and68 of the suture toward body tissue. Therefore, when thesections66 and68 of thesuture52 are wrapped in the same direction around thecylinder316, the cylinder will freely rotate relative to thehousing314 as thesuture retainer312 is moved along thesuture52 toward the body tissue.
• The overall force transmitting capability of thesuture52 is not impaired by thesuture retainer312. This is because the turns of the loops formed in the left and right sections of thesuture52 around thecylinder316 do not form stress concentrations in the suture. If a knot had been used to interconnect the left andright sections66 and68 of thesuture52, in the manner taught by the prior art, the resulting stress concentration would reduce the overall force transmitting capability of thesuture52.
• Thecylindrical housing314 increases the surface area on body tissue against which force is applied by tension in thesuture52 after thesuture retainer312 has been plastically deformed to grip the suture. This increases the amount of force which may be transmitted through thesuture52 without damaging the body tissue.
Embodiment of FIG.20
• In the embodiment of the invention illustrated inFIGS. 17-19, thecylinder316 is rotatable relative to thehousing314. In the embodiment of the invention illustrated inFIG. 20, cylinders are fixedly connected with the housing. Since the embodiment of the invention illustrated inFIG. 20 is similar to the embodiment of the invention illustrated inFIGS. 17-19, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-19 may be used with the embodiment of the invention illustrated inFIG. 20.
• Asuture retainer356 includes arectangular housing358 which encloses a plurality ofcylinders360,362,364 and366. The cylinders360-366 have parallel central axes which extend parallel to flat rectangular upper andlower side walls370 and372 of thehousing358. Opposite end portions of the cylinders360-366 are fixedly connected with rectangular end walls (not shown) of thehousing358. The central axes of the cylinders360-366 extend perpendicular to the housing end walls to which the cylinders are fixedly connected.
• In the embodiment of the invention illustrated inFIG. 20, the cylinders360-366 are formed of a biodegradable material which is relatively hard. Thehousing358 is formed of a biodegradable material which is relatively soft. By forming thehousing358 of a biodegradable material which is relatively soft, plastic deformation of the housing is facilitated. The relatively hard biodegradable material forming the cylinders360-366 has a low coefficient of friction. Although it is preferred to form the cylinders360-366 andhousing358 of biodegradable materials having different hardnesses, the cylinders and housing could be formed of biodegradable or nonbiodegradable materials having the same hardness if desired.
• Asuture52 has left andright sections66 and68 which are wrapped around the cylinders360-366 in a zig-zag fashion. Thus, theleft section66 of thesuture52 is looped around thecylinders360 and362. Theright section68 of thesuture52 is looped around thecylinders364 and366. Thecylinders360 and362 maintain a pair of smooth, continuous bends in theleft section66 of thesuture52. Similarly, thecylinders364 and366 maintain a pair of smooth, continuous bends in theright section68 of thesuture52. The smooth, continuous bends in thesections66 and68 of thesuture52 are free of stress inducing discontinuities. If desired, a greater or lesser number of bends could be maintained in thesections66 and68 of thesuture52 by a greater or lesser number of cylinders.
• In the embodiment of the invention illustrated inFIG. 20, there is a single partial turn of theleft section66 of the suture around each of thecylinders360 and362. Similarly, there is a single partial turn of theright section68 of thesuture52 around each of thecylinders364 and366. If desired, a plurality of turns or loops could be provided around each of the cylinders360-366 by thesections66 and68 of thesuture52. For example, theleft section66 of thesuture52 could be wrapped for one complete revolution around thecylinder360 and then wrapped for a partial revolution around thecylinder360 before extending to thecylinder362. Similarly, theright section68 of thesuture52 could be wrapped for one complete revolution around thecylinder366 and then wrapped for a partial revolution around thecylinder364 before exiting from thehousing358.
• After thesuture52 has been wrapped around the cylinders360-366 in the manner illustrated schematically inFIG. 20, thesuture retainer356 is moved along thesections66 and68 of thesuture52 toward body tissue. As thehousing358 is moved downward (as viewed inFIG. 20), toward the body tissue, the left andright sections66 and68 of thesuture52 slide along the outer side surfaces of the cylinders360-366. As this occurs, the cylinders360-366 cooperate to maintain a plurality of bends in each of thesections66 and68 of thesuture52.
• Once thehousing358 has been pressed against the body tissue with apredetermined force376 while a predetermined tension is maintained in the left andright sections66 and68 of thesuture52, thehousing358 is plastically deformed to grip thesuture52. Thus, force, indicated byarrows380 and382 inFIG. 20 supplied against a side of thehousing358 opposite from theforce376. This force is effective to plastically deform the material of the housing and to press the-material of the housing against the cylinders360-366 and against thesections66 and68 of thesuture52.
• As the forces indicated by thearrows376,380 and382 plastically deform thehousing358, the material of the housing cold flows under the influence of the force. This cold flow of-the material of the housing results in the left andright sections66 and68 of the suture being firmly pressed against the cylinders360-366 to form a solid bond with the left andright sections66 and68 of thesuture52. Since the material forming the cylinders360-366 is relatively hard, compared to the material forming thehousing358, the housing will deform to a greater extent than the cylinders during cold flow of the material of the housing. However, there will be some plastic deformation of the cylinders360-366.
• The force transmitting capability of thesuture52 is enhanced by minimizing stress concentrations in the suture and by transmitting force from thehousing358 to a large area on the body tissue. The bends formed in thesuture52 around the cylinders360-366 are free of abrupt stress inducing discontinuities. Thehousing358 transmits force to the body tissue located between the opposite sides of the left andright sections66 and68 of thesuture52. Therefore, stress concentrations in both the body tissue and thesuture52 tend to be minimized. If desired, a knot may be tied between the upper (as viewed inFIG. 20) end portions of the left andright sections66 and68 of thesuture52. Although such a knot would provide additional assurance that thesuture52 will not work loose, it is believed that the knot will not be necessary.
• One of the ends of the suture could be fixedly connected with thehousing358. This could be done by forming thesuture52 as one piece with thehousing358 or by using a fastener. If one end of the suture is fixedly connected with thehousing358, one of the sets of cylinders, for example, thecylinders360 and362, could be eliminated.
Embodiment of FIGS.21-22
• In the embodiments of the invention illustrated inFIGS. 9-20, bends are formed in the left andright sections66 and68 of thesuture52 by circular surfaces. In the embodiment of the invention illustrated inFIGS. 21 and 22, the bends are formed in the suture by passages through a rectangular member. Since the embodiment of the invention illustrated inFIGS. 21 and 22 is similar to the embodiment of the invention illustrated inFIGS. 9-20, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-20 may be used with the embodiment of the invention illustrated inFIGS. 21-22.
• Asuture retainer390 is formed in a single rectangular piece of biodegradable material. Thesuture retainer390 includes arectangular body392 formed of a suitable biodegradable material. However, therectangular body392 could be formed of a non-biodegradable material if desired.
• A plurality ofparallel passages394,396 and398 extend between opposite parallel rectangular end surfaces400 and402 of thebody392. The left andright sections66 and68 of thesuture52 zig-zag through thepassages394,396 and398 in a side-by-side relationship. Thesections66 and68 of thesuture52 zig-zag through thepassages394,396 and398 to form a series of bends in the suture.
• Thepassages394,396 and398 in thebody392 of thesuture retainer390 cooperate to form smooth,continuous bends406,408,410 and412 (FIG. 21) in thesections66 and68 of thesuture52. Thus, the left andright sections66 and68 of thesuture52 extend through thestraight passage394.Bends406 and408 are formed in the portions of thesections66 and68 of the suture disposed between thepassage394 and thepassage396. Similarly, bends410 and412 are formed in thesections66 and68 of thesuture52 disposed between thepassages396 and398. Of course, if there were additional passages formed in therectangular body392, additional bends would be formed in thesuture52.
• The bends406-412 in thesections66 and68 of the suture52-are smooth and free of stress inducing discontinuities. By keeping thesuture52 free of stress inducing discontinuities, the force which can be transmitted through the suture tends to be maximized. If a knot was substituted for thesuture retainer390, stress concentrations would be formed and the force transmitting capability of the suture reduced.
• Thepassage394 has amain section418 and agripping section420. Thegripping section420 has a tapered configuration (FIG. 22) and extends sideward from themain section418. The left andright sections66 and68 of thesuture52 may be pulled from themain section418 of thepassage394 into thegripping section420 of the passage. As this occurs, the side surfaces of thepassage394 grip opposite sides of the left andright sections66 and68 of thesuture52 to hold the left and right sections of the suture against axial movement relative to therectangular body392 of thesuture retainer390.
• Thesuture retainer390 is formed of a single piece of biodegradable material, such as polycaperlactone. Of course, other suitable biodegradable or bioerodible materials could be utilized if desired. It is contemplated that thesuture retainer390 could be formed of materials which do not biodegrade.
• After thesuture52 has been inserted into thesuture retainer390, in the manner illustrated schematically inFIG. 21, the suture retainer is moved along the suture toward body tissue (not shown). As thesuture retainer390 is moved along thesuture52, the side-by-side sections66 and68 of the suture slide in the same direction on surfaces of thesuture retainer390.
• To effect movement of thesuture retainer390 along thesuture52, force is applied against thebody392, in the manner indicated schematically by anarrow424 inFIG. 21. This causes thebody392 of thesuture retainer390 to slide along thesections66 and68 of thesuture52. At this time, the left andright sections66 and68 of the suture are tensioned. Therefore, the left and right sections of the suture slide along surfaces of thepassages394,396 and398 as therectangular body392 of thesuture retainer390 is moved toward the body tissue. As this occurs, the bends406-412 move along thesections66 and68 of thesuture52 toward the body tissue.
• When theleading end surface402 on therectangular body392 of thesuture retainer390 engages the body tissue, the force indicated schematically by thearrow424 is increased to a predetermined force. As this occurs, a predetermined tensioning force is applied to the left andright sections66 and68 of thesuture52. This results in thesuture52 being pulled tight to grip the body tissue with a desired force. Therectangular end surface402 on thebody392 of thesuture retainer390 distributes the tension force in thesuture52 over a relatively large area on the body tissue.
• While theretainer body392 is being pressed against the body tissue with the predetermined force and the left andright sections66 and68 of thesuture52 are pulled taut with a predetermined tensioning force, the left andright sections66 and68 of the suture may be pulled towards the right (as viewed inFIGS. 21 and 22). As this occurs, the left andright sections66 and68 of thesuture52 will move from themain section418 of thepassage394 into thegripping section420 of the passage. This results in a frictional grip between theretainer body392 and thesuture52 to hold the suture against movement relative to the retainer body and to maintain the desired tension in the suture.
• While thebody392 of thesuture retainer390 is being pressed against the body tissue with thepredetermined force424 and while the predetermined tension is maintained in the left andright sections66 and68 of thesuture52, the material of thesuture retainer390 is plastically deformed. To plastically deform the material of thesuture retainer390,force applying members428 and430 (FIG. 22) apply a predetermined force against opposite sides of thebody392 of the suture retainer. This force causes cold flowing of the material of thebody392 of the suture retainer.
• As the plastic deformation of thebody392 of thesuture retainer390 occurs, thepassages394,396 and398 are collapsed and the material of thebody392 of thesuture retainer390 cold flows around and grips the left andright sections66 and68 of thesuture52. The plastic deformation of thebody392 of thesuture retainer390 occurs at a temperature below the transition temperature of the material forming the suture retainer. If desired, thesuture retainer390 could be heated to promote cold flow of the material of the suture retainer.
• In the embodiment of the invention illustrated inFIGS. 21 and 22, thegripping section420 mechanically grips a portion of thesuture52. If desired, thegripping section420 could be eliminated and the suture moved into engagement with a projection from thebody392. The upper (as viewed inFIG. 21) portions of thesuture52 could be wrapped around a projection from thebody392. Alternatively, the upper (as viewed inFIG. 21) portions of the suture could be moved into engagement with one or more hook-shaped locking notches on thebody392 of thesuture retainer390.
Embodiments of FIGS.23-25
• In the embodiment of the invention illustrated inFIGS. 21 and 22, the left andright sections66 and68 of thesuture52 extend through thepassages394,396 and398 in a side-by-side relationship. In the embodiments of the invention illustrated inFIGS. 23-25, loops are formed in the left and right sections of the suture around portions of the suture retainer. Since the embodiments of the invention illustrated inFIGS. 23-25 is similar to the embodiment of the invention illustrated inFIGS. 21-22, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-22 could be used with the embodiments of the invention illustrated inFIGS. 23-25.
• A suture retainer440 (FIG. 23) has arectangular body442. A plurality of straight parallelcylindrical passages444,446 and448 extend between flat parallel rectangular end surfaces450 and452 of therectangular body442 of thesuture retainer440. The left andright sections66 and68 of thesuture52 extend through thepassages444,446 and448 in a zig-zag manner.
• Theleft section66 of thesuture52 zigzags through thepassages444,446 and448 in therectangular body442 of thesuture retainer440. When theleft section66 of thesuture52 is inserted into thesuture retainer440, theleft section66 of the suture is first moved downward (as viewed inFIG. 23) throughpassage448. A smooth, continuousfirst bend456 is then formed in theleft section66 of thesuture52 and the left section is moved upward through thepassage446. A smooth, continuoussecond bend458 is then formed in theleft section66 of thesuture52. Theleft section66 of thesuture52 is then moved downward through thepassage444.
• Theright section68 of thesuture52 is also inserted into thesuture retainer440 in a zig-zag fashion. Thus, theright section68 of thesuture52 is moved downward through thepassage444. A smooth, continuousfirst bend462 is formed in theright section68 of thesuture52. Theright section68 of thesuture52 is then moved upward through thepassage446. A smooth, continuoussecond bend464 is then formed in theright section68 of thesuture52. Theright section68 of thesuture52 is then moved downward through thepassage448.
• In the embodiment of the invention illustrated inFIG. 23, the left andright sections66 and68 of thesuture52 are not aligned or in a side-by-side relationship with each other. Thus, thebends456 and458 in theleft section66 of thesuture52 are offset from thebends462 and464 in theright section68 of thesuture52. Thebends456,458,462, and464 are free of stress inducing discontinuities which would tend to weaken thesuture52.
• After thesuture52 has been inserted into thesuture retainer440, in the manner illustrated schematically inFIG. 23, the left andright sections66 and68 of the suture are tensioned and force is applied to therectangular body442 of thesuture retainer440 to move the suture retainer along thesuture52 toward the body tissue. As this occurs, the left andright sections66 and68 of thesuture52 slide in opposite directions along the surfaces of thepassages444,446 and448. As this occurs, the zig-zag portion of thesuture52 is moved along the suture toward the body tissue.
• When the rectangularleading end surface452 of thebody442 of thesuture retainer440 moves into engagement with the body tissue, the suture retainer is pressed against the body tissue with a predetermined force while maintaining a predetermined tension in the left andright sections66 and68 of the suture. Thesuture retainer440 is then plastically deformed to grip the left andright sections66 and68 of thesuture52. To plastically deform the material of thesuture retainer440, force is applied against opposite sides of thesuture retainer440, in the manner indicated byarrows470 and472 inFIG. 23.
• The force indicated by thearrows470 and472 causes cold flow of the material of the suture retainer.440. Thesuture retainer440 is formed from a single piece of biodegradable polymeric material, such as polycaperlactone. The plastic deformation of thesuture retainer440 occurs while the material of the suture is a temperature which is below the transition temperature of the material and is at a temperature close to the temperature of the body tissue. If desired, thesuture retainer440 could be heated to a temperature above the temperature of the body tissue and below the transition temperature of the material of the suture retainer to promote cold flow of the material of the suture retainer.
• In the embodiment of the invention illustrated inFIG. 24, the sections of thesuture52 are wrapped around portions of the suture retainer in smooth, continuous loops. Thus, in the embodiment of the invention illustrated inFIG. 24, asuture retainer480 includes arectangular body482 formed of a biodegradable polymeric material. A plurality of straightcylindrical passages484,486 and488 extend between and are perpendicular to flat parallel end surfaces492 and494 on therectangular body482 of thesuture retainer480.
• Thesuture52 includes left andright sections66 and68. The left andright sections66 and-68 are wrapped, in zig-zag fashion, aroundportions498 and500 of therectangular body482. This results in the formation of left andright loops502 and504 in the left andright sections66 and68 of thesuture52. Theloops502 and504 are free of stress inducing discontinuities.
• When thesuture retainer480 is to be positioned relative to the body tissue of a human patient, the left andright sections66 and68 of thesuture52 are tensioned with a predetermined force. Force is then applied to therectangular body482 of the suture retainer to move the suture retainer downward (as viewed inFIG. 24) along thesuture52. As this occurs, the left andright sections66 and68 slide along surfaces of thepassages484,486 and488. In addition, theloops502 and504 move downward (as viewed inFIG. 4) along thesuture52.
• Theleading end surface494 of therectangular body482 is pressed against the body tissue with a predetermined force while a predetermined tension is maintained in the left andright sections66 and68 of thesuture52. The material of thesuture retainer480 is then plastically deformed to grip the left andright sections66 and68 of thesuture52. When the material of thesuture retainer480 is plastically deformed, the material of the suture retainer is below its transition temperature and is at a temperature close to the temperature of the body tissue. Therefore, the material of thesuture retainer480 cold flows under the influence of force applied against the suture retainer to collapse thepassages484,486 and488 and grip the left andright sections66 and68 of thesuture52.
• The flat rectangular end surfaces of thesuture retainer480 applies force over a relatively large surface area on the body tissue. This reduces any tendency for thesuture52 to cut or separate the body tissue. The force which can be transmitted through thesuture52 is maximized by eliminating sharp bends in the suture. If thesuture retainer480 was eliminated and the suture was secured with a knot, the suture would be weakened by stress concentrations formed at sharp bends in the knot.
• In the embodiment of the invention illustrated inFIG. 25, asuture retainer510 includes arectangular body512 formed of a biodegradable polymeric material. A plurality of straight parallelcylindrical passages514,516,518, and520 extend between flat rectangular end surfaces522 and524 of thebody512.
• Thesuture52 includes left andright sections66 and68. Separate left andright loops530 and532 (FIG. 25) are formed in thesections66 and68 of thesuture52. Thus, theleft loop530 in theleft section66 of thesuture52 extends through thepassages518 and520 in therectangular body512 of thesuture retainer510. Similarly, theright loop532 extends through thepassages514 and516 in therectangular body512 of thesuture retainer510.
• When thesuture retainer510 is to be positioned relative to body tissue, the left andright sections66 and68 of thesuture52 are tensioned. Force is then applied to thesuture retainer510 to move the suture retainer downward (as viewed inFIG. 25) along thesuture52 into engagement with the body tissue. After thelower end surface524 of therectangular body512 of thesuture retainer510 has been pressed against the body tissue with a predetermined force, the biodegradable polymeric material of thesuture retainer510 is plastically deformed by applying force against the suture retainer and cold flowing the material of the suture retainer. Cold flow of the material of thebody512 collapses the passages514-520. The material of thebody512 then firmly grips thesuture52.
• After plastic deformation of the material of thebody512, thesuture retainer510 at a temperature below the transition temperature of the material, a knot may be tied between the upper portions of the suture. This knot would be pressed tightly against theupper end surface522 of therectangular body512 of thesuture retainer510. This know would be disposed at a location between the locations of thepassages516 and518 before plastic deformation of thebody512 of thesuture retainer510. It is believed that such a knot may not be necessary.
• In the embodiment of the invention illustrated inFIGS. 24 and 25, the passages through the rectangular bodies of the suture retainer are shorter than the passages through the rectangular body of the suture retainer illustrated inFIG. 23. However, it should be understood that the passages through the rectangular bodies of the suture retainers illustrated inFIGS. 24 and 25 could have a longer length if desired.
• In the embodiments of the invention illustrated inFIGS. 23-25, thesuture52 is separate from thesuture retainers440,480 and510. However, one end of thesuture52 could be connected with any one of he sutureretainers440,480 and510. If this was done only one of thesections66 or68 would be zigzagged through passages in a suture retainer. For example, an end of theleft section66 of thesuture52 may be fixedly connected with one of thesuture retainers440,480 or510. Only theright section68 of thesuture52 would have to be inserted through the passages in the onesuture retainer440,480 or510. The end of thesuture52 could be fixedly connected with asuture retainer440,480 or5110 by a suitable fastener or by forming the suture as one piece with the suture retainer.
Embodiment of the Invention Illustrated in FIGS.26,27 and28
• In the embodiment of the invention illustrated inFIGS. 21-25, the suture retainer is formed form a single piece of biodegradable polymeric material. In the embodiment of the invention illustrated inFIGS. 26-28, the suture retainer is formed from a plurality of pieces of biodegradable polymeric material. Since the embodiment of the invention illustrated inFIGS. 26-28 is similar to the embodiment of the invention illustrated inFIGS. 21-25, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-25 could be used with the embodiment of the invention illustrated inFIGS. 26-28.
• A suture retainer540 (FIG. 26) includes a base542 (FIGS. 26 and 27) and a sleeve or cap544 (FIGS. 26 and 28). Thebase542 has acircular flange548 which extends radially outward from an upstanding central or post portion550 (FIGS. 26 and 27). Thepost portion550 has a generally cylindrical configuration and is disposed in a coaxial relationship with thecircular flange548. Theflange548 andpost portion550 are integrally formed from one piece of a biodegradable material, such as polycaperlactone. However, thebase542 and/or thecap544 could be formed of a material which is not biodegradable.
• A pair ofpassages554 and556 are provided in thepost portion550. Thepassage554 includes a radially inward and downward slopingentrance portion558 and a main portion560. The main portion560 extends parallel to the longitudinal central axis of thepost portion550. Theentrance portion558 of thepassage554 extends inwardly from a cylindricalouter side surface562 of thepost portion550. The main portion560 of thepassage554 extends perpendicular to a flat circularbottom side surface564 of theflange548.
• Thepassage556 has the same configuration as thepassage554. Thepassage556 is disposed diametrically opposite to thepassage554. Thepassages554 and556 have a nonlinear configuration and form bends in he left andright sections66 and68 of thesuture52. Thepassages554 and556 are circumscribed by anannular recess568 which extends around the lower end of thepost portion550 adjacent to theflange548.
• The upper end of thepost portion550 has a flat circular side surface570 (FIG. 27). Theflat side surface570 on thepost portion550 extends parallel to and is coaxial with the flat bottom side surface564 (FIG. 26) on theflange548. Theannular recess568 is coaxial with theflange548. Thebase portion542 is formed of a biodegradable material, such as polycaperlactone. Other polymers which are biodegradable or bioerodible may be used. It is also contemplated that thebase portion542 could be formed of a polymer which does not biodegrade, such as an acetyl resin.
• In addition to thebase portion542, thesuture retainer540 includes the one piece, cylindrical cap or sleeve544 (FIG. 28). Thecap544 has a cylindricalouter side surface574. Acircular end surface576 extends radially inwardly from the side surface547. Thecap544 has a cylindrical cavity578 (FIG. 26) which is disposed in a coaxial relationship with the cylindricalouter side surface574 andend surface576.
• A pair ofcylindrical passages582 and584 extend between thecavity578 and thecircular end surface576 of the cap544 (FIG. 26). Thecavity578 has acylindrical side surface588 which is disposed in a coaxial relationship with theouter side surface574 on thecap544. In addition, thecavity578 has acircular end surface590 which extends parallel to and is coaxial with theouter end surface576 on the cap544 (FIG. 26). An annular rib594 (FIG. 26) projects radially inward from the cylindricalinner side surface588 of thecavity578. Thecap544 is integrally formed as one piece of a suitable biodegradable polymeric material, such as polycaperlactone. However, thecap544 may be formed of a material which is not biodegradable.
• When thesuture52 is to be connected with body tissue54 (FIG. 26), one of the sections of the suture, for example, theright section68, is threaded through thepassage582 into thecavity578 in thecap544. At this time, thesuture52 extends away from thecap544 so that theleft section66 of the suture is disposed at a remote location. Theright section68 of the suture is then threaded through thepassage554 in thebase portion542. Theright section68 of thesuture52 is then threaded through a passage598 in thebody tissue54.
• In addition, theright section68 of thesuture52 is threaded through apassage600 in a force distribution member orbutton602 which engages a lower side of thebody tissue54. Thesuture52 is then threaded through asecond passage604 in thebutton602 and apassage606 in thebody tissue54. Thebutton602 distributes tension forces in thesuture52 over a relatively large area on the lower (as viewed inFIG. 26)side108 of the body tissue. However, thebutton602 could be omitted if desired.
• Theright section68 of the suture is then threaded upward (as viewed inFIG. 26) through thepassage556 in thebase portion542 and into thecavity578 in thecap544. Theright section68 of thesuture52 is threaded out of thecavity568 through thepassage584. As this occurs, theleft section66 of thesuture52 is pulled into thecap544 andbase portion542.
• Once thesuture52 has been threaded through thebase portion542 andcap544 in the manner previously explained, thesections66 and68 of the suture are tensioned and thebase portion542 is slid along thesuture52. As this occurs, the bends formed in the left andright sections66 and68 of thesuture52 by thepassages554 and556 in thebase portion542 are moved along the suture toward thebody tissue54. Thebottom side surface564 of thebase portion542 is then pressed against anupper side surface98 of thebody tissue54 in the manner illustrated inFIG. 26.
• The flat circularbottom side surface564 of theflange548 transmits force from thesuture52 to a relatively large area on thesurface98 of thebody tissue54. At this time, the tension in aconnector portion610 of thesuture52 will pull the force distribution member orbutton602 firmly upward against alower side surface108 of thebody tissue54. This results in thebody tissue54 being clamped between the relatively large bottom surface area on theflange548 and thebutton602.
• While the tension is maintained in the left andright sections66 and68 of thesuture52, thecap544 is slid downward along thesuture52 into engagement with thebase portion542. Further downward movement of the sleeve or cap544 resiliently deflects therib594 radially outward. Continued downward movement (as viewed inFIG. 26) of the sleeve or cap544 moves therib594 along theouter side surface562 of thepost portion542 into alignment with therecess568. As this occurs, therib594 snaps into therecess568.
• Once therib594 is snapped into therecess568, the left and right sections of thesuture52 are firmly gripped between the cylindricalinner side surface588 of thecavity578 in thecap544 and the cylindricalouter side surface562 of thepost portion550. In addition, the left andright sections66 and68 of thesuture52 are gripped between thecircular end surface590 of thecavity578 and thecircular end surface570 of thepost portion550. Thecap544 andpost portion550 cooperate to form bends in the left andright sections66 and68 of the suture.
• Under certain circumstances, it is believed that the mechanical gripping action provided between thecap544 andbase portion542 of thesuture retainer540 may be sufficient to hold thesuture52 against movement relative to the body tissue. However, it is believed that it will be preferred to enhance the grip of thesuture retainer540 on thesuture52 by plastically deforming the material of the suture retainer. The plastic deformation of thesuture retainer540 occurs with the suture retainer at a temperature which is below the transition temperature of the biodegradable polymeric material forming thebase portion542 and cap544 of the suture retainer.
• Plastic deformation of thebase portion542 andcap portion544 of thesuture retainer540 is accomplished by applying force against the cylindricalouter side surface574 of thecap544 in the same manner as illustrated schematically inFIG. 12. The force applied against the cylindrical outer side surface574 (FIG. 26) of thecap544 causes the material of the cap to cold flow and press against the left andright sections66 and68 of thesuture52. As this occurs, thepassages554 and556 in thebase portion542 collapse. Due to the bends provided in the left andright sections66 and68 of thesuture52 in passing through thepassages554 and556, and around the outside of thepost portion550 of the-base portion542, there is an extremely secure gripping action of thesuture52 upon plastic deformation of material of thecap544 andbase portion542.
• The force applied against theouter side surface574 of thecap544 is sufficient to cause cold flow of the material of thecap544 andpost portion550. Cold flow of the material of thecap544 firmly clamps thesections66 and68 of thesuture52 between the cap andpost portion550. Cold flow of the material of thepost portion550 collapses thepassages554 and556. This results in a cold bonding of the material of thepost portion550 with thesuture52. Thesuture52 is then securely gripped by thepost portion554.
• It is preferred to form thebase portion542 and thecap544 of thesuture retainer540 of the same biodegradable polymeric material. However, thebase portion542 could be formed of a biodegradable material which is somewhat harder than the biodegradable material forming thecap544. This would facilitate plastic deformation of thecap544 under the influence of force applied against theouter side surface574 of the cap. If desired, thebase portion542 and/orcap544 could be formed of a material which does not biodegrade.
• After thesuture retainer540 has been plastically deformed by cold flowing the material of the suture retainer, thesuture52 may be knotted. Thus, a knot may be tied to interconnect the left andright sections66 and68 of thesuture52 in a known manner. During the tying of this knot, thesuture52 is pulled taut against the end surfaces576 on thecap544. The knot will be disposed between thepassages582 and584 in thecap544. The knot will not reduce the overall force transmitting capability of thesuture52 since thesuture retainer540 will be disposed between the knot and thebody tissue54. Although such a knot may be provided to be certain that thesuture52 does not work loose under the influence of varying loads, it is believed that thesuture retainer540 will be very capable of holding thesuture52 without the additional protection provided by the knot.
Embodiment of FIG.29
• In the embodiment of the invention illustrated inFIGS. 13-16, thesuture52 is wrapped around aconical body242 which is moved into asleeve284 of asuture retainer244. In the embodiment of the invention illustrated inFIG. 29, the suture extends through passages formed in a conical body and a sleeve. Since the embodiment of the invention illustrated inFIG. 29 is similar to the embodiment of the invention illustrated inFIGS. 13-16, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-28 could be used with the embodiment of the invention illustrated inFIG. 29.
• Asuture retainer622 includes aconical body624 and a cylindrical sleeve orbase626. Theconical body624 has anouter side surface628 which is formed as a portion of a right circular cone. Theouter side surface628 of theconical body624 extends between flat parallel circular end surfaces630 and632. The end surfaces630 and632 are disposed in a coaxial relationship with each other and with theouter side surface628 of theconical body624. Theend surface632 of theconical body624 has a diameter which is smaller than the diameter of theend surface630 of the conical body.
• A pair ofcylindrical passages636 and638 are disposed in theconical body624. Thepassages636 and638 have straight central axes which are skewed at an acute angle to the central axis of theconical body624. If desired, thepassages636 and638 could have nonlinear central axes to promote the forming of bends in thesuture52. For example, thepassages636 and638 could have a helical configuration. Theconical body624 is formed from a single piece of a biodegradable polymeric material, such as polycaperlactone.
• Thecylindrical sleeve626 has a cylindricalouter side surface642. Theside surface642 extends between a flatannular end surface644 and acircular end surface646. The end surfaces644 and646 extend parallel to each other and are disposed in a coaxial relationship.
• Arecess650 is formed in thecylindrical sleeve626. Therecess650 is of the same size and configuration as theconical body624. Therecess650 has aside wall652 which is formed as a portion of a cone. In addition, therecess650 has acircular end surface654 which extends parallel to theouter end surface646 on thesleeve626. Theside wall652 of therecess650 has the same angle of taper as theouter side surface628 of theconical body624. However, if desired, the taper in theside wall652 of therecess650 could be slightly less than the taper in theouter side surface628 of theconical body624 to promote a wedging action between the conical body and thesleeve626.
• A pair of parallelcylindrical passages660 and662 extend between and are perpendicular to theend wall654 of therecess650 and theend surface646 on thesleeve626. Thepassages660 and662 have a linear configuration. However, thepassages660 and662 could have a nonlinear configuration if desired.
• When thesuture retainer622 is to be positioned relative to body tissue, theleft section66 of thesuture52 is inserted through thepassage660 in thesleeve626. Theleft section66 of thesuture52 is then inserted through thepassage636 in theconical body624. Similarly, theright section68 of thesuture52 is inserted through thepassage662 in thesleeve626 and thepassage638 in theconical body624.
• The left andright sections66 and68 of thesuture52 are then tensioned and-thesleeve626 is moved along thesuture52 into engagement with the body tissue. When theend surface646 of the sleeve has engaged the body tissue, the force applied against the sleeve and tension in thesections66 and68 of thesuture52 are increased. While a predetermined force is applied against thesleeve626, theconical body624 is moved along the left andright sections66 and68 of thesuture52 into therecess650 in the sleeve. As this occurs, the left andright sections66 and68 of the suture are clamped between theouter side surface628 of theconical body624 and theconical side wall652 of therecess650.
• To enhance the gripping action between theconical body624 and thesleeve626, force is applied against the cylindricalouter side surface642 of the sleeve in the same manner as indicated schematically inFIG. 12. This force causes plastic deformation of the material of thesleeve626 to firmly grip theconical body624 and the left andright sections66 and68 of thesuture52. The force applied against theouter side surface642 of thesleeve626 causes a cold flowing of the material of thesleeve626. The cold flowing of the material of thesleeve626 will collapse thepassages660 and662 to firmly grip the portion of the left andright sections66 and68 of thesuture52 extending through the passages.
• In addition, the force applied against thesleeve626 will be sufficient to cause plastic deformation, that is, cold to flowing, of the material of theconical body624 to collapse thepassages636 and638. This results in the portions of the left andright sections66 and68 of thesuture52 disposed in thepassages636 and638 being firmly gripped by material of theconical body624.
• It is contemplated that one end of thesuture52 could be fixedly connected with thesuture retainer622. Thus, one end of thesuture52 could be fixedly connected with theconical body624. Alternatively, one end of thesuture52 could be fixedly connected with thesleeve626. It is also contemplated that a knot could be tied between the left andright sections66 and68 of thesuture52 at a location above (as viewed inFIG. 92) the suture retainer. The knot would be tied adjacent to theend surface650 on theconical body624. The knot would be tied immediately after plastically deforming the material of the suture retainer. It should be understood that thesuture retainer622 should be more than adequate to hold thesuture52 and the knot may be omitted.
• The use of thesuture retainer622, rather than forming a knot to interconnect the twosections66 and68 of thesuture52, increases the force transmitting capability of thesuture52. This is because the stress concentrations induced by the forming of a knot are avoided.
• In addition, the use of thesuture retainer62, rather than forming a knot to interconnect the twosections66 and68 of thesuture52, reduces stress concentrations in the body tissue. Theflat end surface646 distributes tension forces in thesuture52 over a relatively large surface area on the body tissue. This minimizes stress concentrations in the body tissue and minimizes any tendency for the body tissue to be cut or separated by the force applied against the body tissue.
Embodiment of FIGS.30 and31
• In the embodiment of the invention illustrated inFIG. 29, the left andright sections66 and68 of thesuture52 are inserted into passages formed in theconical body624. In the embodiment of the invention illustrated inFIGS. 30 and 31, the conical body34 has a hinge section which is pivotal to open the conical body and facilitate insertion of the left and right sections of the suture. Since the embodiment of the invention illustrated inFIGS. 30 and 31 is similar to the embodiment of the invention illustrated inFIG. 29, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-92 could be used with the embodiment of the invention illustrated inFIGS. 30 and 31.
• A suture retainer670 (FIG. 30) includes aconical body672 and asleeve674. Theconical body672 is formed as twosections676 and678 (FIG. 31). Thesections676 and678 of the conical body are pivotally interconnected at ahinge680. Thehinge680 is integrally formed as one piece with thesections676 and678 of theconical body672. Thehinge680 enables the left andright sections66 and68 (FIG. 30) of thesuture52 to be inserted through anopening684. Theopening684 extends between axially opposite ends of theconical body672.
• Thesleeve674 includes acircular flange688 which extends radially outward from a cylindricalouter side surface690 of thesleeve674. Aconical recess692 has a relatively large open end in an upperannular end surface694 of thesleeve674 and a relatively small open end in a flatannular end surface696 disposed on the bottom of theflange688.
• The left andright sections66 and68 of the suture are inserted through the open endedconical recess692 in thesleeve674. The left andright sections66 and68 of thesuture52 are then inserted through the opening684 (FIG. 31) into theconical body672.
• While tension is maintained in the left andright sections66 and68 of thesuture52, thesleeve674 is moved along the suture until theleading end surface696 on the bottom of theflange688 engages the body tissue. Thesleeve674 is then pressed against the body tissue with a predetermined force while a predetermined tension is maintained in the left andright sections66 and68 of thesuture52. Theconical body672 is then moved along the left andright sections66 and68 of thesuture52 into the open endedrecess692 in thesleeve674.
• Force is then applied against theouter side surface690 of thesleeve674 to plastically deform the sleeve. As this occurs, the material of thesleeve674 cold flows radially inward and applies force against theconical body672. This force is sufficient to cause cold flowing of the material of the conical body and gripping of the left andright sections66 and68 of thesuture52 with the material of theconical body672.
• Theconical body672 andsleeve674 are formed of a biodegradable material. However, theconical body672 and/orsleeve674 could be formed of a different material if desired.
Embodiment of FIGS.32 and33
• In the embodiment of the invention illustrated inFIGS. 29, 30 and31, two-piece suture retainers are utilized to grip the left and right sections of thesuture52. In the embodiment of the invention illustrated inFIGS. 32 and 33, a one-piece tubular suture retainer is utilized to grip the left and right sections of the suture. Since the embodiment of the invention illustrated inFIGS. 32 and 33 is similar to the embodiment of the invention illustrated inFIGS. 29-31, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-31 could be used with the embodiment of the invention illustrated inFIG. 32.
• In the embodiment of the invention illustrated inFIG. 32, asuture retainer700 is formed from a single piece of a biodegradable polymeric material, such as polycaperlactone. Thesuture retainer700 includes an annular flange orbase702 and an upright tubular cylindricalmain section704. The tubular cylindricalmain section704 is disposed in a coaxial relationship with thebase702. A straightcylindrical passage706 extends through the tubularmain section704 andbase702 of thesuture retainer700. If desired, thepassage706 could have a nonlinear configuration.
• Left andright sections66 and68 of thesuture52 are inserted through thepassage706 in thesuture retainer700. While a predetermined tension is maintained in the left andright sections66 and68 of thesuture52, a predetermined force, indicated schematically by thearrows708 inFIG. 32, is applied to themain section704 of the suture retainer. Theforce708 is distributed over a relatively large surface area on thebody tissue54 by thebase702. Thesuture retainer700 is then plastically deformed to grip the left andright sections66 and68 of thesuture52. To plastically deform thesuture retainer700,force application members712 and714 are pressed against opposite sides of themain section704 of thesuture retainer700 with a predetermined force, indicated schematically by thearrows716 inFIG. 32. When theforce716 is applied to thesuture retainer700, the suture retainer is at a temperature below the transition temperature of the material forming the suture retainer. Therefore, theforce716 is effective to cause cold flow of the material of thesuture retainer700.
• The force applied against thesuture retainer700 by theforce applying members712 and714 is measured by a transducer orload cell720. The magnitude of theforce716 is transmitted from theload cell720 to adisplay unit722. When a predetermined minimum force.716 has been applied to thesuture retainer700 for a predetermined minimum period of time by theforce applying members712 and714, thedisplay unit722 activates anindicator724.
• Theforce applying members712 and714 are configured to form a plurality ofbends728 and730 in the tubularmain section704 of the suture retainer700 (FIG. 33). Thus, theforce applying members712 and714 deform themain section704 of thesuture retainer700 from a straight cylindrical configuration (FIG. 32) to a nonlinear configuration (FIG. 33). Thebends728 and730, in combination with the cold plastic deformation of the material of thesuture retainer700, result in thesuture retainer700 having a firm grip on the left andright sections66 and68 of thesuture52. It should be understood that theforce application members712 and714 could be configured to form a greater number of bends in themain section704 of the suture retainer.
• In the illustrated embodiment of thesuture retainer700, a single passage706 (FIG. 32) extends through the suture retainer. If desired, a plurality of passages could be provided in thesuture retainer700. If this was done, theleft section66 of the suture would be inserted through one of the passages and theright section68 would be inserted through another passage.
• Thebends728 and730 (FIG. 33) in thesuture retainer700 form smooth, continuous bends in thesuture52. This avoids the formation of stress concentrations in thesuture52. If a knot had been utilized in place of thesuture retainer700 to interconnect thesections66 and68 of he suture52, stress concentrations would have been formed in the suture and the overall force transmitting capability of the suture would have been impaired.
• Theannular base702 projects radially outward from the cylindrical main section. Since the tension force transmitted to thesuture retainer700 by thesuture52 is transmitted to thebody tissue54 by thebase702, the suture tension force is transmitted to a relatively large surface area on the body tissue. This minimizes the possibility of thesuture52 andsuture retainer700 being pulled downward (as viewed inFIG. 33) into thebody tissue54 by the tension force in the suture. In addition, thelarge base702 minimizes the possibility of damage to thebody tissue54.
• If desired, a knot could be tied between the upper end portions of thesections66 and68 of the suture. This knot would be disposed above and would press against an upper (as viewed inFIG. 33) end of the suture retainer. Although stress concentrations would be formed in thesuture52 at the knot, the knot would not impair the force transmitting capability of the portion of the suture engaging thebody tissue54. This is because thesuture retainer700 would be disposed between thebody tissue54 and the knot.
Embodiment of FIG.34
• In the embodiment of the invention illustrated inFIG. 34, the suture retainer has a tubular configuration. Since the embodiment of the invention illustrated inFIG. 34 is similar to the embodiments of the invention illustrated inFIGS. 1-33, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-33 could be used with the embodiment of the invention illustrated inFIG. 34. A suture52 (FIG. 34) has left andright sections66 and68 which extend through a tubularcylindrical suture retainer740 intobody tissue54. Anapparatus741 for pressing thesuture retainer740 against thebody tissue54 includes a tubularcylindrical plunger742 having a cylindricalcentral passage744 through which the left andright sections66 and68 of thesuture54 extends. Theplunger742 is enclosed in a tubularcylindrical housing746.
• Theplunger742 is pressed downward, relative to thehousing746 against thesuture retainer740 with a predetermined force, indicated byarrows748 inFIG. 34. An annular transducer orload cell750 provides an output indicative of the magnitude of theforce748 with which thesuture retainer740 is pressed against thebody tissue54 by theplunger742.
• While the left andright sections66 and68 of thesuture54 are being tensioned with a predetermined force and while theplunger742 is being pressed against thesuture retainer740 with a predetermined force, thesuture retainer740 is plastically deformed. To plastically deform thesuture retainer740, a plurality of force applying or clampmembers754 and756 are pressed against the suture retainer with a predetermined minimum force, indicated schematically byarrows760 inFIG. 34. Theforce application members754 and756 may have an arcuate configuration to conform to the cylindrical configuration of thesuture retainer740 or may have a flat configuration. The force applied against thesuture retainer740 by theforce760 applyingmembers754 and756 is sufficient to cause plastic deformation of the material of the suture retainer.
• Theforce760 is applied against the suture retainer while the suture retainer is at a temperature which is below the transition temperature of the biodegradable polymer which forms the suture retainer. Thus, the suture retainer is at approximately the same temperature as thebody tissue54 when theforce760 is applied against the suture retainer. Theforce760 causes the material of the suture retainer to cold flow and grip the left andright sections66 and68 of thesuture54 in the manner previously explained.
• Although theapparatus741 has been illustrated inFIG. 34 in association with thesuture retainer740, it is contemplated that theapparatus741 could be used with any one of the suture retainers ofFIGS. 1-33. Although theforce applying members754 and756 have an arcuate configuration to grip the arcuate outer side surface of thesuture retainer740. It is contemplated that the force applying members could have a different configuration to grip a suture retainer having a noncylindrical configuration. Embodiment ofFIG. 35 In the embodiment of the invention illustrated inFIG. 35, an apparatus similar to the apparatus illustrated inFIG. 34 is utilized to install a suture retainer having the same construction as the suture retainer ofFIGS. 13-16. Since the embodiment of the invention illustrated inFIG. 35 is similar to the embodiment of the invention illustrated inFIG. 34, similar terminology will be utilized to identify similar components.
• An apparatus or tool770 (FIG. 35) is utilized to position asuture retainer772 relative tobody tissue54. Theapparatus770 includes a tubular housing orbase774 through which acylindrical plunger776 extends. Aforce application member778 extends from theplunger776 and is engageable with an upper or trailingend surface780 of thesuture retainer772. A biasingspring782 urges theforce application member778 to the extended position illustrated inFIG. 35.
• Upon application of a predetermined force to the trailingend surface780 of thesuture retainer772 by theforce application member778, an indicator connected with a shaft786.indicates to an operator of theapparatus770 that a desired force has been applied against thesuture retainer772. The indicator may be either a direct reading of the position of theshaft786 relative to theplunger776 or an output from a transducer, such as a load cell.
• Theapparatus770 includes agripper assembly790 which is operable to grip and to deform thesuture retainer772. Thegripper assembly790 includes a leftforce application member792 and a rightforce application member794. The force application-members792 and794 engage opposite sides of thesuture retainer772. Theforce application members792 and794 are configured to correspond to the shape of an outer side surface of thesuture retainer772.
• Anactuator member798 is connected with the leftforce application member792. Asecond actuator member800 is connected with the rightforce application member794. Theactuator members798 and800 are pivotally mounted on thehousing774 at a pivot connection indicated schematically at802 inFIG. 35.
• Downward force is manually applied to an upperinput end portion806 of theplunger776 while a predetermined tension is maintained in the left andright sections66 and68 of thesuture52. The downward (as viewed inFIG. 35) force applied against theplunger776 is transmitted through thespring782 to theforce application member778. Theforce application member778 applies force to the trailingend surface780 of thesuture retainer772 to press aleading end surface810 on thesuture retainer772 against theside surface98 of thebody tissue54.
• Anadjustable stop member812 is connected with thehousing774. Thestop member812 is adjustable to limit the extent of downward movement of theinput end portion806 of theplunger776 relative to thehousing774. This enables thestop member812 to limit the amount of force transmitted through thespring782 to thesuture retainer772 to a predetermined force.
• Manual force is applied against upper (as viewed inFIG. 35)end portions816 and818 of theactuator members798 and800. During the application of the manual force to theupper end portions816 and818 of theactuator members798 and880, the predetermined tension is maintained in the left andright sections66 and68 of thesuture52. In addition, the predetermined downward force is transmitted from theplunger776 through thespring782 and forceapplication member778 to thesuture retainer772.
• The manual force applied to theend portions816 and818 of theactuator members798 and800 is transmitted to theforce application members792 and794. Theforce application members792 and794 are pressed against thesuture retainer792 with sufficient force too plastically deform the suture retainer by cold flowing the material of the suture retainer.
• Although thesuture retainer772 may have any one of the constructions illustrated inFIGS. 1-34, thesuture retainer772 has the same construction as thesuture retainer244 ofFIG. 13. Thus, thesuture retainer772 includes aconical body822 and acylindrical sleeve824. Thesuture52 has aleft section66 which is wrapped for a plurality of turns around theconical body822 and is disposed in ahelical groove830 formed in theconical body822. Similarly, aright section68 of thesuture52 is wrapped for a plurality of turns around theconical body822 and is disposed in ahelical groove832 formed in theconical body822.
• When thesuture retainer772 is to be positioned relative to thebody tissue54, thesuture52 is inserted through thesleeve824. Theleft section66 of the suture is then positioned in thehelical groove830 in theconical body822 of thesuture retainer772. Theright section68 of thesuture52 is positioned in thehelical groove832 in theconical body822 of thesuture retainer772.
• The apparatus ortool770 is then operated to hold thesuture retainer772 in the manner illustrated schematically inFIG. 35. Thus, theforce application member778 is positioned in abutting engagement with the trailingend surface780 of thesuture retainer772. At the same time, the left and rightforce application members792 and794 grip thesleeve824 of thesuture retainer772. This results in theconical body822 of thesuture retainer772 being telescopically pressed into thesleeve824 while the sleeve is held by theforce application members792 and794.
• IS While the predetermined tension is maintained in the left andright sections66 and68 of thesuture52, thetool770 and thesuture retainer772 are moved along thesuture52 toward thebody tissue54. Thetool770 is moved along a path which extends parallel to the taut portions of the left andright sections66 and68 of thesuture52 which extend upward (as viewed inFIG. 35) from thesuture retainer772. As thesuture retainer772 is moved along thesuture52 toward thebody tissue54, the left andright sections66 and68 of the suture slide along thegrooves830 and832. Thegrooves830 and832 are effective to maintain the helical turns or loops in the left andright sections66 and68 of thesuture52 as thesuture retainer772 moves along thesuture52 toward thebody tissue54.
• The force required to slide thesuture retainer772 along thesuture52 is transmitted from thetool700 to the suture retainer. Thus, force is transmitted from theforce application member778 to the trailingend surface780 of theconical body822. At the same time, a clamping force is transmitted from theforce application members792 and794 to thesleeve824. Thesleeve824 is securely held by theforce application members792 and794 while theconical body822 is pressed axially against the sleeve by theforce application member778. During movement of thesuture retainer772 along thesuture52, the force applied against the suture retainer by thetool700 is ineffective to cause significant deformation of the suture retainer.
• At this time, thetool770 extends along the portions of the left andright sections66 and68 of thesuture52 extending upward (as viewed inFIG. 35) from thesuture retainer772. Since thetool770 extends from thesuture retainer772 in the same direction as the left andright sections66 and68 of thesuture52, the tool can be used to position the suture retainer relative tobody tissue54 in very restricted space commonly present in operating environments.
• When theleading end surface810 on thesuture retainer772 engages the upper (as viewed inFIG. 35)side surface98 of the body tissue54 (FIG. 35), the force applied. against theactuator members798 and800 is reduced. Manual force is then applied against theinput end portion806 of theplunger776 to move the plunger downward and compress thespring782. Thestop member812 is engaged by theinput end portion806 of theplunger776 when a predetermined force is being transmitted through thespring782 and forceapplication member778 to thesuture retainer772.
• This results in the predetermined downward force being transmitted from theforce application member778 to thesuture retainer772 to press the conical body against thesleeve824. The predetermined downward force is then transmitted from thesleeve824 andconical body822 to thebody tissue54. While thesuture retainer772 is being pressed against the body tissue with the predetermined downward force, a predetermined tension force is maintained in the left andright sections66 and68 of thesuture52.
• In the schematic illustration ofFIG. 35, there is space between theconical body822 and thesleeve824. In addition, there is space between thesleeve824 and theforce application members792 and794. It should be understood that the conical outer side surface of thebody822 is pressed firmly against the correspondingly shaped conical inner side surface of thesleeve824. It should also be understood hat theforce application members792 and794 are pressed against the cylindrical outer side surface of thesleeve824. At this time, the left andright sections66 and68 of the suture are tensioned.
• While the predetermined force is being applied against the trailingend surface780 of thesuture retainer772 by theforce application member778, manual force is applied against theupper end portions816 and818 of theactuator members798 and800 to effect plastic deformation of thesuture retainer772. Thus, the left and rightforce applying members792 and794 are pressed against thecylindrical sleeve824 with sufficient force to plastically deform both the cylindrical sleeve and theconical body822 of thesuture retainer772. At this time, thesuture retainer772 is at approximately the same temperature as thebody tissue54 and is at a temperature which is below the transition temperature of the biodegradable polymeric material forming the suture retainer. Therefore, cold flowing the material of the suture retainer occurs under the influence of the force applied against thesuture retainer772 by the left and rightforce applying members792 and794.
• The cold flowing of the material of thesuture retainer772 under the influence of the force applied to the suture retainer by theforce application members792 and794 results in thesuture52 being firmly gripped in the manner set forth in association with thesuture retainer244 of the embodiment ofFIGS. 13-16. The application of force to theactuator members798 and800 is then interrupted. The application of force to theinput end portion806 of theplunger776 is also interrupted. Theapparatus770 is then moved upward (as viewed inFIG. 35) away from the suture retainer.
• Although theapparatus770 has been disclosed herein in association with thesuture retainer772, it is contemplated that the apparatus could be utilized to install suture retainers having a different construction. If theapparatus770 is used to install a suture retainer having an outer side surface with a configuration which is different than the configuration of outer side surface of thesuture retainer772, the configuration of theforce application members792 and794 would be modified to correspond to the configuration of the suture retainer to be installed. For example, if the suture retainer had a flat outer side surface, theforce application members792 and794 would be modified to have flat surfaces to engage the suture retainer. If the suture retainer had the spherical outer side surface of the suture retainer50 (FIG. 2), theforce application members792 and794 would have configurations corresponding to the configuration of portions of a sphere.
Embodiment of the Invention Illustrated in FIG.36
• In the embodiment of the invention illustrated inFIG. 35, anapparatus770 for installing asuture retainer772 is disclosed. In the embodiment of the invention illustrated inFIG. 36, a second apparatus for installing a suture retainer is disclosed. Since the embodiment of the invention illustrated inFIG. 36 is similar to the embodiment of the invention illustrated inFIG. 35, similar terminology will be utilized to identify similar components.
• An apparatus ortool870 for positioning asuture retainer872 relative tobody tissue54 includes a base orhousing874. Acylindrical plunger876 is slidable in thehousing874. Theplunger876 is connected with left and right force application orclamp members880 and882 by a pair oflinkages884. Although only one of thelinkages884 has been shown inFIG. 36, it should be understood that there is a second linkage having the same construction as thelinkage884 connected with theplunger876.
• A biasingspring888 extends around theplunger876 and urges the plunger upward (as viewed inFIG. 36). The force transmitted from the biasingspring888 through theplunger876 andlinkages884 urges the left and rightforce application members880 and882 into engagement with thesuture retainer872. The force provided by thespring888 is insufficient to cause significant deformation of thesuture retainer872. However, the force provided by thespring888 is sufficient to enable theforce application members880 and882 to hold thesuture retainer872 during sliding of the suture retainer along thesuture52.
• A transducer orload cell892 is connected with theplunger876 and provides an output signal, over a lead894 to adisplay unit896. This output is indicative of the magnitude of the force transmitted through theplunger876. When a predetermined force has been applied by theforce application members880 and882 against thesuture retainer872 for a predetermined minimum length of time, anindicator898 is activated by thedisplay unit896.
• Thespecific suture retainer872 illustrated inFIG. 36 has a one-piece tubular cylindrical construction. Thesuture52 has left andright sections66 and68 which are wrapped around thesuture retainer872 in the same manner as in which thesuture52 is wrapped around thesuture retainer50 ofFIG. 2. Thus, aloop904 is formed in theleft section66 of thesuture52 and extends around a portion of the tubularcylindrical suture retainer872. Similarly, aloop906 is formed in theright section68 of thesuture52 and extends around a portion of the tubularcylindrical suture retainer872.
• In the embodiment of the invention illustrated inFIG. 36, a force distribution member orbutton910 is provided at theupper side surface98 of thebody tissue54. The force transmission member orbutton910 distributes the force applied by thesuture retainer872 to thebody tissue54 over a relatively large area on the body tissue. If desired, a second force distribution member could be provided between the suture and alower side surface108 of thebody tissue54. Since thesuture retainer872 is effective to apply force to a relatively large area, thebutton910 may be omitted if desired.
• When thesuture retainer872 is to be installed in the body tissue, the twosections66 and68 of the suture are sewn through thebody tissue54 and are then inserted into thesuture retainer872. During insertion of the left andright sections66 and68 of thesuture52 into thesuture retainer872, theloops904 and906 are formed in the twosections66 and68 of the suture.
• Theplunger876 is then manually moved downward in thehousing874 against the influence of the biasingspring888 to move theforce application members880 and882 apart. When theforce application members880 and882 have been positioned adjacent to opposite sides of thesuture retainer872, the downward force applied against theplunger876 is released. This results in thebiasing spring888 moving theplunger876 upward to actuate thelinkages884 to press theforce application members880 and882 against opposite sides of thesuture retainer874.
• The left andright sections66 and68 of thesuture52 are then tensioned. The apparatus ortool870 is then moved along the left andright sections66 and68 of thesuture52 toward the body tissue. As this occurs, theloops904 and906 are displaced downwardly along the tensionedsections66 and68 of thesuture52 toward the body tissue. During downward displacement of theloops904 and906 toward thebody tissue54, the left andright sections66 and68 of thesuture52 slide along surfaces on thesuture retainer872.
• After thesuture retainer872 has been moved into engagement with the button or forcedistribution member910, the leading end of thesuture retainer872 is pressed against the button with a predetermined force. This force is transmitted through theplunger876 and is measured by thetransducer892. Once thesuture retainer872 has been pressed against the button or forcedistribution member910 with a predetermined force, theplunger876 is manually pulled upward relative to thehousing874. This results in the transmission of force through thelinkage884 to theforce applying members880 and882.
• Theforce applying members880 and882 apply sufficient force to thesuture retainer872 to effect plastic deformation of the suture retainer. At this time, the suture retainer-is at a temperature below the transition temperature of the biodegradable polymeric material of the suture retainer. Thus, the suture retainer is at a temperature which is the same as the temperature of thebody tissue54. The plastic deformation of thesuture retainer872 results in cold flowing of the material of the suture retainer and gripping of the left andright sections66 and68 of thesuture52 in the manner previously explained in conjunction with the embodiments of the invention illustrated inFIGS. 1-35.
• It should be understood that thetool870 may be used to install any of the suture retainers illustrated inFIGS. 1-33. Of course, the force application orclamp members880 and882 would be configured so as to grip the outer side surface of the specific suture retainer with which the tool is to be used.
Embodiment of FIGS.37 and38
• In the embodiment of the invention illustrated inFIGS. 37 and 38, the suture is tensioned with a force which is a function of a selected suture size and strength. Since the embodiment of the invention illustrated inFIGS. 37 and 38 is similar to the embodiments of the invention illustrated inFIGS. 1-36, similar terminology will be utilized to identify similar components.
• Achart918 setting forth various available suture sizes is illustrated schematically inFIG. 37. Thechart918 also sets forth the strength of each of the available suture sizes. It is contemplated that the specific strength of a particular suture size may vary depending upon the material from which the suture is constructed and the manufacturer of the suture. By consulting thechart918, a surgeon can select a suture of a size and strength suitable for a particular use. Thus, a relatively large suture having substantial strength may be selected when body tissue is to be connected with a bone or when portions of a bone are to be interconnected by the suture. On the other hand, the relatively small suture size having a relatively small strength may be selected when delicate body tissue, such as stomach or intestinal tissue, is to be interconnected with the suture.
• Once a suture of a size and strength suitable for retaining specific body tissue has been selected, the suture is connected with body tissue and a retainer is moved along the suture toward the body tissue. Force is transmitted from the suture retainer and from the suture to the body tissue. The magnitude of the force which is transmitted from the suture retainer and the suture to the body tissue will be a function of the selected size and strength of the suture.
• The suture retainer may have any one of the constructions illustrated inFIGS. 1 through 36. Alternatively, the suture retainer could have any one of the constructions illustrated in U.S. Pat. No. 5,593,425. It is contemplated that the suture could be connected with body tissue in any one of the manners illustrated in U.S. Pat. Nos. 5,593,425; 5,584,862; 5,549,631; 5,527,343; and/or 5,464,426.
• In the embodiment of the invention illustrated inFIG. 38, asuture922 extends throughbody tissue924. Thebody tissue924 includes aninner layer926 of body tissue and anouter layer928 of body tissue. A first orinner end portion932 of thesuture922 is connected with asuture anchor934.
• Thesuture anchor934 could have any desired construction. For example, thesuture anchor934 could have a construction similar to any one of the constructions disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. However, the illustrated embodiment of thesuture anchor934 is a circular disk or button having a pair of central openings around which theend portion932 of thesuture922 is tied.
• Thesuture922 extends straight through theinner layer926 andouter layer928 ofbody tissue924. Anouter side surface938 of the inner layer ofbody tissue926 is engaged by aninner side surface940 of theouter layer928 of body tissue. The side surfaces938 and940 of the two segments orlayers926 and928 of body tissue are disposed in flat apposition. Thus, theouter side surface938 of theinner layer926 is disposed in flat abutting engagement with theinner side surface940 of theouter layer928 where thesuture922 extends through the inner and outer layers.
• Asuture retainer944 cooperates with thesuture anchor934 to hold thesuture922 against movement relative to thebody tissue924. Thesuture retainer944 has a spherical configuration. Acylindrical passage946 extends axially through thesuture retainer944.
• Although the suture922 (FIG. 38) extends straight through thepassage946 in thesuture retainer944, bends and/or loops could be formed in thesuture922 around thesuture retainer944 in the manner illustrated inFIG. 2. Thus, two bends, corresponding to thebends72 and74 ofFIG. 2, could be formed in thesuture922 by wrapping a turn of the suture around a portion of thesuture retainer944. This will result in the formation of a single loop, corresponding to theloop86 ofFIG. 2, around thesuture retainer944.
• Thesuture retainer944 is formed of one piece of spherical polymeric material having a relatively low coefficient of friction. Thesuture retainer944 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer944 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer944 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 retainer944 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, the suture retainer could be formed of acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer944 could be formed of para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• Thesuture922 may be formed of natural or synthetic materials. Thesuture922 may be a monofilament or may be formed of a plurality of interconnected filaments. Thesuture922 may be biodegradable or non-biodegradable. It may be preferred to form thesuture922 of the same material as thesuture retainer944. However, thesuture922 could be formed of a material which is different than the material of the suture retainer.
• In accordance with a feature of the embodiment of the invention illustrated inFIGS. 37 and 38, thesuture922 is tensioned with a force which is a function of the size and strength of the suture, as indicated by thechart918. In addition, thesuture retainer944 is pressed against thebody tissue924 with a force which is also a function of the size and strength of thesuture922, as indicated by thechart918 ofFIG. 37. Although thesuture944 is disposed in direct engagement with and is pressed against anouter side surface950 of the outer layer orsegment928 ofbody tissue924, a force distribution member or button could be positioned between thesuture retainer944 and theouter side surface950 of theouter layer928 of body tissue.
• Thesuture922 is tensioned by aforce application assembly954 which is connected with the second orouter end portion956 of thesuture922. Theforce application assembly954 includes a transducer orload cell958 which provides an output signal indicative of a force, indicated schematically at960 inFIG. 38 which is applied to the second orouter end portion956 of thesuture922. Theforce960 has a magnitude which is a function of the size and strength of thesuture922, as indicated by thechart918. Thus, theforce960 may be equal to 0.80 times the strength of thesuture922 as indicated-by thechart918. Of course, the strength of thesuture922 will vary with variations in the size of thesuture922.
• Thesuture retainer944 is pressed against theouter side surface960 of the outer layer orsegment928 ofbody tissue924 with a force which is also a function of the strength and size of thesuture922, as indicated by thechart918 ofFIG. 37. Aforce application member964 is used to apply force against thesuture retainer922. Theforce application member964 has acylindrical opening966 which extends through the force application member. Thesuture922 extends through theopening966. A slot may be formed in theforce application member964 to enable thesuture922 to be moved into theopening966. Alternatively, thesuture922 could be inserted through theopening966 before theend portion956 of the suture is connected with theforce application assembly954.
• Forces, indicated schematically at968 and970 inFIG. 38, are applied againstopposite end portions972 and974 of theforce application member964 to press thesuture retainer944 directly against theouter layer928 of body tissue or against a force transmitting member disposed between thesuture retainer944 and theouter layer928 of body tissue. The combined force, indicated schematically thearrows968 and970 inFIG. 38, is a function of the size and strength of thesuture922, as indicated by thechart918. It is contemplated that the combinedforces968 and970 may be equal to theforce960. In the specific example previously mentioned, this would result in theforces968 and970 having a sum or total equal to 0.80 times the strength of thesuture922 as indicated by thechart918. Alternatively, the summation of theforces968 and970 could exceed theforce960 or be less than theforce960.
• Thesuture retainer944 slides downward (as viewed inFIG. 38) along thesuture922 under the influence of theforce application member964. At this time, thesuture922 is tensioned by theforce application assembly954 so that the portion of the suture extending between thesuture anchor934 and theforce application assembly954 is straight, as illustrated inFIG. 38. However, at this time, the force which is applied to theouter end portion956 of thesuture922 by theforce transmitting assembly954 may be substantially less than the force which is indicated schematically by thearrow960 inFIG. 38.
• After thesuture retainer944 has been moved along thesuture922 to the position illustrated inFIG. 38, the force applied against the suture retainer by theforce application member964 is increased. At the same time, the force applied to theouter end portion956 of thesuture922 by theforce application assembly954 is increased. The force applied against thesuture retainer944 by theforce application member964 is increased until the force, indicated schematically by thearrows968 and970 inFIG. 38, is equal to a predetermined function of the strength of thesuture922, as indicated by thechart918 for the particular size of the suture. At the same time, the force applied to theouter end portion956 of thesuture922 by theforce application assembly954 is increased to the force indicated schematically by thearrow960 inFIG. 38. As was previously mentioned, the force indicated by thearrow960 is a predetermined function of the strength of thesuture922 as indicated by thechart918.
• While thesuture922 is being pulled straight under the influence of tension in the suture due to theforce960 and while thesuture retainer944 is being pressed againstouter layer928 of body tissue or against a suitable force distribution member, thesuture retainer944 is plastically deformed to firmly grip thesuture922. Thus, while thesuture retainer944 is being pressed against theouter layer928 ofbody tissue924 under the combinedforces968 and970 and while thesuture922 is being tensioned by theforce960, a pair offorce application members978 and980 are pressed against opposite sides of thesuture retainer944. The force applied against thesuture retainer944 by theforce application members978 and980 plastically deforms the material of the suture retainer.
• In the illustrated embodiment of the invention, the plastic deformation of thesuture retainer944 is effective to cause cold flowing of the material of the suture retainer. Force indicated byarrows982 and984 inFIG. 38, is applied against thesuture retainer944 by theforce application members978 and980. This force is effective to cause flowing of the material of thesuture retainer944 at a temperature below the transition temperature range of the material of the suture retainer. Although the illustratedforce application members978 and980 have flat force transmitting surfaces, each of the force transmitting members could have force transmitting surfaces with a configuration corresponding to the configuration of a portion of a sphere.
• The cold flowing of the material of thesuture retainer944 results in collapsing of thepassage946 and in flowing of the material of thesuture retainer944 around the portion of thesuture922 extending through thepassage946. This enables the material of thesuture retainer944 to bond to and obtain a firm grip on thesuture922. The cold flowing of the material of thesuture retainer944 occurs at a temperature which is below the transition temperature of the material forming the suture retainer.
• It is believed that it may be preferred to plastically deform the material of the suture retainer944 (FIG. 38) by applying force against areas on the suture retainer and cold flowing material of the suture retainer in the manner previously explained. However, if desired, thesuture retainer944 may be heated before theforce application members982 and984 apply force against the suture retainer. The heated material of the suture retainer will be moved into engagement with a portion of thesuture922 extending through thepassage946.
• The temperature to which the material of the suture retainer is heated would be low enough so that the heated material would not cause significant deformation of the material of thesuture922. Thus, the material of thesuture retainer944 may be heated to a temperature within its transition temperature range but less than a temperature which would result in a complete melting of the material of the suture retainer. As the material of thesuture retainer944 is pressed against thesuture922 by theforce application members978 and980, the heated plastic material of the suture retainer is cooled to a temperature below its transition temperature range. As this occurs, the plastic material of thesuture retainer944 bonds to a portion of thesuture922 without significant deformation of the suture.
• The interconnection between the material of thesuture retainer944 and the portion of thesuture922 extending through the suture retainer is the result of both molecular attraction (adhesion) of the material of the retainer to the material of the suture and due to a mechanical interconnection between the material of the suture retainer and the material of the suture. Thus, as the material of thesuture retainer944 cools, it mechanically grips thesuture922 so that the suture is held against movement relative to the suture retainer by interfacial forces between the material of the suture retainer and the material of the suture. There is a fusing of the material of thesuture retainer944 to the material of thesuture922 along the portion of the suture which extends through the suture retainer.
• Whether thesuture retainer944 is plastically deformed by cold flowing the material of the suture retainer or by a flowing of heated material of the suture retainer, the suture retainer grips thesuture922 without significant deformation of the suture. Therefore, the strength of thesuture922 is not impaired and corresponds to the strength indicated by thechart918 for the particular size of the suture.
• When the layers orsegments926 and928 of thebody tissue924 are to be interconnected with thesuture922, theend portion932 of the suture is connected with ananchor member934. Thesuture922 is then threaded with a needle or similar device, through thelayers926 and928 of body tissue.
• It should be understood that in certain situations, a surgeon will not have access to both the inner and outer sides of the body tissue. In situations where the surgeon does not have access to both sides of the body tissue, theanchor934 is formed with a configuration which enables it to be inserted through the layers orsegments926 and928 of body tissue along with thesuture922. Thus, theend portion932 of thesuture922 is connected with theanchor934 while the anchor and suture are both disposed outside of the patient's body.
• The suture anchor, with thesuture922 connected thereto, is then inserted through bothlayers926 and928 of thebody tissue924. This may be accomplished in the manner disclosed in U.S. Pat. No. 5,464,426. However, it should be understood that the suture anchor could have a configuration other than the specific configuration disclosed in U.S. Pat. No. 5,464,426. For example, thesuture anchor934 could have a configuration similar to any one of the configurations disclosed in U.S. Pat. No. 5,527,343.
• In the embodiment of the invention illustrated inFIG. 38, thesuture anchor934 is positioned in engagement with aninner side surface988 on theinner layer926 of body tissue. It is contemplated that thesuture anchor934 could be disposed within theinner layer926 of body tissue. Thus, the suture anchor could be disposed at a location midway between theinner side surface988 and theouter side surface938 of thelayer926 of body tissue. Mounting of the suture anchor in the body tissue in this manner would be particularly advantageous if the suture anchor is mounted in bone in the manner illustrated in the aforementioned U.S. Pat. No. 5,527,343.
• Although thesuture retainer944 has been illustrated inFIG. 38 as having a spherical construction, generally similar to the suture retainer ofFIGS. 1 and 2, it is contemplated that thesuture retainer944 could have a configuration corresponding to the configuration of any one of the suture retainers illustrated inFIGS. 1 through 36 herein.
Embodiment of FIG.39
• In the embodiment of the invention illustrated inFIGS. 37 and 38, thesuture922 has a single section which extends through thesuture retainer944. In the embodiment of the invention illustrated inFIG. 39, the suture has a plurality of sections which extend through the suture retainer. Since the embodiment of the invention illustrated inFIG. 39 is similar to the embodiment of the invention illustrated inFIGS. 1-38, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiment of the invention illustrated inFIGS. 1-38 may be used with the embodiment of the invention illustrated inFIG. 39.
• A suture retainer1000 (FIG. 39) is utilized to secure a knownsuture1002 against movement relative tobody tissue1004. Thesuture1002 extends through anouter layer1006 and aninner layer1008 of the body tissue. Thesuture1002 has been illustrated schematically inFIG. 39 as extending throughpassages1010 and1012 in the outer andinner layers1006 and1008 ofbody tissue1004. However, thesuture1002 could be sewn through thebody tissue1004 without forming thepassages1010 and1012 in the body tissue.
• Although thesuture1002 has been shown inFIG. 39 in association with soft body tissue, it is contemplated that thesuture1002 could be associated with hard body tissue. It is also contemplated that thesuture1002 could extend through a suture anchor in a manner similar to that disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343.
• Thesuture1002 has aleft section1016 and aright section1018. The left andright sections1016 and1018 of thesuture1002 extend through thesuture retainer1000. If desired, thesuture1002 could be integrally formed as one piece with thesuture retainer1000. If this was done, the end of thesection1016 or1018 of thesuture1002 would be connected with thesuture retainer1000. Alternatively, a single section of thesuture1002 could extend through the suture retainer, in the manner illustrated for the embodiment ofFIG. 38.
• Although thesections1016 and1018 of thesuture52 could extend straight through thesuture retainer1000, as shown inFIG. 38 for thesuture922, it is preferred to form a plurality of bends in thesuture1002. In the illustrated embodiment, bends are formed in the left andright sections1016 and1018 of thesuture1002 by wrapping a turn of theleft section1016 around a portion of thesuture retainer1000. Similarly, bends are formed in theright section1018 of thesuture1002 by wrapping a turn in the right section of the suture around a portion of thesuture retainer1000. A single loop is formed in theleft section1016 of thesuture1002 around a portion of thesuture retainer1000. Similarly, a single loop is formed in theright section1018 around a portion of thesuture retainer1000. A greater or lesser number of loops could be provided in the left andright sections1016 and1018 if desired. Thesuture1002 cooperates with thesuture retainer1000 in the same manner as is illustrated inFIGS. 1 and 2 herein.
• Thesuture retainer1000 has a spherical configuration. Acylindrical passage1022 extends diametrically through thespherical suture retainer1000. If desired, thesuture retainer1000 could have a different configuration. For example, thesuture retainer1000 could have any one of the configurations illustrated inFIGS. 1 through 36. If desired, a plurality of passages having the same or different configurations, could be provided in thesuture retainer1000.
• A surgeon selects thesuture1002 to have a particular size and strength in accordance with a chart, corresponding to thechart918 ofFIG. 37. Aforce application assembly1030 is connected with end portions of the left andright sections1016 and1018 of thesuture1002. Theforce application assembly1030 tensions thesuture1002 with a force, indicated schematically by anarrow1034 inFIG. 39.
• In addition, aforce application member1038 applies force against thesuture retainer1000 urging the suture retainer towards thebody tissue1004. The force applied by theforce application member1038 to thesuture retainer1000 moves or slides the suture retainer along thesuture1002 toward thebody tissue1004. In the embodiment of the invention illustrated inFIG. 39, thesuture retainer1000 is pressed against theouter layer1006 of body tissue under the influence of force applied against thesuture retainer1000 by theforce application member1038. However, if desired, a force distribution member, such as a button, could be provided between thesuture retainer1000 and thebody tissue1004. In addition, a force distribution member or button could be provided between aconnector section1042 of thesuture1002 and theinner layer1008 of body tissue.
• In accordance with a feature of this embodiment of the invention, thesuture1002 is tensioned by theforce application assembly1030, with aforce1034 which is a function of the strength of thesuture1002. In accordance with another feature of this embodiment of the invention, theforce application member1038 is effective to apply forces indicated schematically byarrows1046 and1048, which are a function of the strength of thesuture1002, to thesuture retainer1000.
• The combined effects of theforce application assembly1030 and theforce application member1038 result in the left andright sections1016 and1018 of thesuture1002 being tensioned with a force which is a function of the strength of thesuture1002 and in the transmission of a force from thesuture retainer1000 to thebody tissue1004 which is a function of the strength of thesuture1002. Thus, theforce1034 is a function of the strength of thesuture1002. For example, theforce1034, with which thesuture1002 is tensioned, may be equal to 0.80 times the strength of the suture. Similarly, the combinedforces1046 and1048 which are transmitted from thesuture retainer1000 to thebody tissue1004 may be 0.80 times the strength of the suture.
• While thesuture1002 is being tensioned with theforce1034 and while theforces1046 and1048 are being applied to thesuture retainer1000 to press the suture retainer against the body tissue,force application members1052 and1054 are effective to apply forces, indicated schematically byarrows1056 and1058 against thesuture retainer1000. The force applied by theforce application members1052 and1054 plastically deforms the material of thesuture retainer1000.
• The plastic deformation of thesuture retainer1000 is effective to cause cold flowing of material of the suture retainer. The force indicated by thearrows1056 and1058 is applied against thesuture retainer1000 by theforce application members1052 and1054 for a predetermined length of time. This force is effective to cause flowing of the material of thesuture retainer1000 at a temperature below the transition temperature range for the material of the suture retainer. Although the illustratedforce application members1052 and1054 have flat force transmitting surfaces, each of theforce application members1052 and1054 could have force transmitting surfaces with a configuration which corresponds to the configuration of a portion of a sphere.
• The cold flowing of the material of thesuture retainer1000 results in a collapsing of thepassage1022 and the flowing of the material of the suture retainer around thesections1016 and1018 of thesuture1002. This enables the material of thesuture retainer1000 to bond to and obtain a firm grip on thesuture1002. The cold flowing of the material of thesuture retainer1000 occurs at a temperature which is below the transition temperature of the material forming the suture retainer.
• During the time in which theforce application members1052 and1058 are effective to apply force against thesuture retainer1000, the suture retainer is pressed against theouter layer1006 of thebody tissue1004 under the combined influence of theforces1046 and1048 which are a function of the strength of thesuture1002. In addition, a predetermined tension is maintained in thesections1016 and1018 of thesuture1002 by theforce application assembly1030. Thus, thesections1016 and1018 of thesuture1002 tension with aforce1034 which is a function of the strength of thesuture1002 while theforce application members1052 and1054 are effective to plastically deform the material of thesuture retainer1000.
• Once thesuture retainer1000 has been plastically deformed to grip thesuture1002, theforce transmitting members1052 and1054 disengage from thesuture retainer1000. At the same time, theforce application member1038 is moved away from thesuture retainer1000 and theforce application assembly1030 interrupts the application of tensioning force tosuture1002. Thesuture retainer1000 grips thesuture1002 and maintains the tension in the portions of thesections1016 and1018 of the suture which extend through thepassages1010 and1012 even through theforce application assembly1030 is no longer effective to tension the suture.
• Thesuture retainer1000 may be formed of many different materials. However, it is believed that it will be preferred to form the suture retainer of a biodegradable polymer. Although it is preferred to form thesuture retainer1000 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable.
• In the illustrated embodiment of the invention, thesuture1002 is formed of the same material as thesuture retainer1000. Thesuture1002 may be formed of a natural or synthetic material and may be a monofilament or formed by a plurality of interconnected filaments. Thesuture1002 may be biodegradable or non-biodegradable.
• In the foregoing description, the material of thesuture retainer1000 has been plastically deformed by cold flowing of the material of the suture retainer. It is contemplated that thesuture retainer1000 could be heated to a temperature in the transition temperature range for the material of the suture retainer. Theforce application members1052 and1054 could apply force against the heated material of thesuture retainer1000 to cause a flowing of the heated material of the suture retainer.
Embodiment of FIGS.40-42
• A suture retainer1070 (FIG. 42) includes a holder or retainer member1072 (FIG. 40) and a tubular member1074 (FIG. 41). Thesuture retainer1070 is utilized to secure a knownsuture1076 against movement relative to by tissue1078 (FIG. 42). In the embodiment of the invention illustrated inFIG. 42, thesuture1076 is connected with asuture anchor1082. However, thesuture1076 could be connected with body tissue in many different ways, including those illustrated inFIGS. 1, 9,26,36,38, and39 herein. Thesuture anchor1082 could have any one of many different known constructions, including the constructions illustrated in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-39 could be used with the embodiment of the invention illustrated inFIGS. 40-42.
• The tubular member1074 (FIG. 41) has a cylindricalouter side surface1086. Theouter side surface1086 extends betweenannular end surfaces1088 and1090 disposed at axially opposite ends of thetubular member1074. Acylindrical passage1092 extends between the axiallyopposite end surfaces1088 and1090 of thetubular member1074. Although thetubular member1074 has been illustrated inFIG. 41 has having a cylindricalouter side surface1086, it is contemplated that thetubular member1074 could have an outer side surface with a different configuration, for example, a rectangular configuration.
• A notch orrecess1096 may be formed in thetubular member1074. Thenotch1096 is disposed midway between the end surfaces1088 and1090. Thenotch1096 extends through thepassage1092. Although it is preferred to form thenotch1096 in thetubular member1074, it is contemplated that the notch could be omitted if desired. If thenotch1096 is omitted, the cylindricalouter side surface1086 would extend between theopposite end surfaces1088 and1090 and would be free of discontinuities.
• The holder member1072 (FIG. 40) has a generally C-shaped configuration. Theholder member1072 includes amain section1100 and pair ofleg sections1102 and1104. In the illustrated embodiment of the invention, themain section1100 andleg sections1102 and1104 have a rectangular cross-sectional configuration. However, it is contemplated that themain section1100 andleg sections1102 and1104 could have a different cross-sectional configuration if desired.
• Theleg sections1102 and1104 extend perpendicular to themain section1100. However, it should be understood that themain section1100 andleg sections1102 and1104 could have a different configuration if desired. For example, themain section1100 andleg sections1102 and1104 could have a circular cross-sectional configuration. Theleg sections1102 and1104 could be skewed in an acute angle to central axis of themain section1100.
• A pair offlanges1108 and1110 extend toward each other from outer end portions of theleg sections1102 and1104 (FIG. 40). Theflanges1108 and1110 define anopening1112 to arecess1114 defined by the holder member1172. The illustratedrecess114 has a polygonal configuration. However, therecess114 could have an arcuate configuration if desired.
• Theflanges1108 and1110 havestraight edges1118 and1120 which extend parallel to each other and perpendicular to the central axis of theleg sections1102 and1104. Although it is preferred to form theflanges1108 and1110 withstraight edges1118 and1120, the flanges could be formed with edges having a different configuration, for example, a curved configuration.
• The tubular member1174 (FIG. 41) and theholder member1072 are formed of a polymeric material having a relatively low coefficient to friction. The polymeric material forming theholder member1072 andtubular member1074 is biodegradable. One biodegradable polymer which may be utilized to form theholder member1072 andtubular member1074 is polycaperlactone. Alternatively, theholder member1072 andtubular member1074 could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. It is contemplated that other biodegradable or bioerodible copolymers could be utilized if desired. If desired, theholder member1072 could be formed of one known biodegradable copolymer and thetubular member1074 could be formed of a different biodegradable copolymer.
• Although it is preferred to form theholder member1072 andtubular member1074 of a biodegradable material, they could be formed of a material which is not biodegradable. For example, theholder member1072 and/or thetubular member1074 could be formed of an acetyl resin, such as “Delrin” (Trademark). Alternatively, theholder member1072 and/ortubular member1074 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (Trademark). If desired, either theholder member1072 or thetubular member1074 could be formed of a material which is biodegradable and the other member formed of a material which is not biodegradable.
• When the suture retainer1070 (FIG. 42) is to be used to secure thesuture1076 relative to thebody tissue1078, the suture is inserted through thepassage1092 in thetubular member1074, in the manner illustrated inFIG. 41. Thetubular member1074 is then slid along thesuture1076 toward thebody tissue1078 with theend surface1090 of the tubular member leading. Theend surface1090 of the tubular member is moved through the opening1112 (FIG. 40) in theholder member1072.
• Although only a single section of thesuture1076 extends through thetubular member1074, two or more sections of the suture could extend through thetubular member1074. For example, a pair of sections of thesuture1076 could extend through thetubular member1074 in much the same manner as in which a pair ofsections66 and68 of asuture52 extend through themain section704 of thesuture retainer700 ofFIG. 32.
• Thesuture1076 is then tensioned with a predetermined force which is a function of the known size and strength of the suture. Theleg section1104 of theholder member1072 is pressed against the body tissue1178 (FIG. 42) with a predetermined force. The leading end portion of thetubular member1074 is then pressed firmly against theleg section1104 of theholder member1072 with a predetermined force which corresponds to the force with which the holder member is pressed against thebody tissue1078.
• Thetubular member1074 is then bent at thenotch1096. This resiliently deforms thetubular member1074 from the linear configuration illustrated inFIG. 41 to the bent configuration illustrated inFIG. 42. As thetubular member1074 is elastically bent, the predetermined tensioned is maintained in thesuture1076.
• While thetubular member1074 is being pressed against theholder member1072 with a force sufficient to apply a predetermined force against thebody tissue1078 through the holder member, thetubular member1074 is resiliently bent from the straight configuration ofFIG. 41 to the bent configuration ofFIG. 42. As this occurs, the trailing end portion of thetubular member1074, on which theend surface1088 is located, is moved into the recess1114 (FIG. 40) in theholder member1072. Thebent tubular member1074 has the generally V-shaped configuration illustrated inFIG. 42.
• Theedges1018 and1020 (FIG. 40) on theflanges1108 and1110 press against the outer side surface1086 (FIG. 41) of thetubular member1074 to hold the tubular member against resiliently springing outward from the generally V-shaped configuration to which the tubular member has been resiliently deflected (FIG. 42). At this time, anarcuate bend portion1124 of thetubular member1074 extends out of therecess1114 in-theholder member1072 through theopening1112. Thelinear edges1118 and1120 of theflanges1108 and1110 apply force against thetubular member1074 to hold the tubular member in the generally V-shaped configuration illustrated inFIG. 42.
• Thesuture1076 is firmly gripped by the portion of thepassage1092 extending through thebend portion1124 of thetubular member1074. Gripping of thesuture1076 is promoted by the notch1096 (FIG. 41). Thenotch1096 results in surfaces on thetubular member1074 which form the portion of thepassage1092 intersecting thenotch1096 engaging thesuture1076 to hold the suture.
• The generally V-shaped configuration of the resiliently deflected tubular member1074 (FIG. 42) results in thesuture1076 being held with sufficient force to maintain the predetermined tension in the portion of the suture extending between thebend portion1124 of thetubular member1074 and thesuture anchor1082. This tension results in thetubular member1074 being pressed against theholder member1072 with sufficient force to press theleg section1104 of theholder member1072 against thebody tissue1078 with a predetermined force.
• Once thetubular member1074 has been bent and positioned in therecess1114 in theholder member1072, in the manner illustrated schematically inFIG. 42, thesuture retainer1070 may be plastically deformed to increase the grip of thetubular member1074 on thesuture1076. Thus, if desired, while the predetermined tension is present in thesuture1076 and while theholder member1072 is being pressed against thebody tissue1078 with a predetermined force, force is applied against opposite sides of thesuture retainer1070. The force is applied to the suture retainer in a direction extending perpendicular to the longitudinal central axis of themain section1100 of theholder member1072 and extending through the center of therecess1114. The force applied against thesuture retainer1070 plastically deforms both theholder member1072 and thetubular member1074.
• The plastic deformation of theholder member1072 andtubular member1074 is effective to cause cold flowing of material of both the holder member and the tubular member. This force is effective to cause flowing of the material of theholder member1072 and thetubular member1074 at a temperature below a transition temperature range for the material of theholder member1072 andtubular member1074. The cold flowing of the material of theholder member1072 and thetubular member1074 results in a reduction in the size of therecess114 in theholder member1072 and a closing of thepassage1092 through thetubular member1074.
• As the material of thetubular member1074 is plastically deformed at a temperature below the transition temperature range of the material, there is a collapsing of thepassage1092 through the tubular member. This results in the material of thetubular member1074 bonding to and obtaining a very strong grip on thesuture1076. The manner in which force is applied against opposite sides of thesuture retainer1072 may be similar to that illustrated schematically inFIGS. 3, 8,18,22,32,34,35, and38 herein.
• Although it is believed that it may be preferred to apply force against both theholder member1072 and tubular member1074 (FIG. 42) to effect cold flowing of the material forming the holder member and tubular member, force may be applied against only thetubular member1074 if desired. Thus, the force application members could be constructed so as to have a configuration corresponding to the configuration of therecess114 in theholder member1072 and to extend a short distance through theopening1112 into the recess.
• The force application members would be positioned in engagement with diametrically opposite sides of thetubular member1074 and would be aligned with opposite ends of therecess114. The force application members would then be moved toward each other along an axis extending through the center of therecess1114 in a direction perpendicular to a longitudinal central axis of themain section1100 of theholder member1072. A predetermined force sufficient to cause cold flowing of thetubular member1074 would then be applied against opposite sides of the tubular member. This would result in a cold flowing of the material of thetubular member1074 and collapsing of thepassage1092 through the tubular member without significant deformation of theholder member1072.
• Regardless of whether theholder member1072 andtubular member1074 or just thetubular member1074 are plastically deformed, thepassage1092 through the tubular member is collapsed and the material of the tubular member pressed firmly against thesuture1076. The force applied against thetubular member1074 is sufficient to embed thesuture1076 in the material of thetubular member1074 to obtain a cold bonding of the material of thetubular member1074 with thesuture1076. A cold bonding of the material forming the inner side surface of thepassage1092 with thesuture1076 securely interconnects the suture and thetubular member1074. The manner in which the material of thetubular member1074 engages thesuture1076 is the same as is illustrated schematically inFIG. 4.
• It is preferred to effect cold flowing of the material of thetubular member1074 and, if desired, the material of theholder member1072 without the addition of heat. However, it is contemplated that thetubular member1074 and, if desired, theholder member1072 could be heated to a temperature which is somewhat above the temperature of the body tissue1078 (FIG. 42). Although the material of theholder member1072 andtubular member1074 could be heated into the transition temperature range for the materials forming the members, it is believed that it will be desired to maintain the temperature of theholder member1072 andtubular member1074 at a temperature below the transition temperature of the materials forming these member. However, it should be understood that in certain situations, it may be desired to heat theholder member1072 and/or thetubular member1074 to a temperature which is in the transition temperature range for the materials forming these members. If this was done, there would be a hot flowing, rather cold flowing of the material of theholder member1072 and/ortubular member1074.
• The foregoing description has assumed that force will be applied against thesuture retainer1070, with or without the application of heat, to effect flowing of the material of the suture retainer. However, it is believed that it may be preferred to omit the application of force to thesuture retainer1070. Thus, the resilientlybent tubular member1074 is held against movement from the bent condition ofFIG. 42 under the influence of its own natural resilience, by theholder member1072 to grip thesuture1076 without additional deformation of thesuture retainer1070. By omitting the application of force to thesuture retainer1070 after thetubular member1074 has been bent and gripped by theholder member1072, installation of the suture retainer is simplified.
• In the embodiment of the invention illustrated inFIG. 42, theleg section1104 of theholder member1072 is pressed firmly against thebody tissue1078. If desired, a force distribution member could be provided between theholder member1072 and thebody tissue1078. For example, a circular force distribution member having a central passage could be provided between theholder member1072 andbody tissue1078. Alternatively, theleg section1104 of theholder member1072 could be provided with an enlarged base so as to have a larger area of engagement with thebody tissue1078.
• In the embodiment of the invention illustrated inFIG. 42,opposite end surfaces1088 and1090 on thetubular member1074 are disposed in therecess1114. However, it is contemplated thatbent tubular member1074 could be inserted into therecess1114 in theholder member1072 with thebend portion1124 disposed on one side of theholder member1072 and the end surfaces1088 and1090 disposed on the opposite side of the holder member. This would result in theholder member1072 functioning as a band which would extend around thetubular member1074 at a location between thebent portion1124 and the end surfaces1088 and1090. The band formed by theholder member1072 would hold portions of thetubular member74 in engagement with each other at a location offset from thebend portion1124.
Embodiment of FIG.43
• In the embodiment of the invention illustrated inFIGS. 40-42, thetubular member1074 is provided with a cylindricalouter side surface1086 which is engaged by theedges1118 and1120 on the holder orretainer member1072. In the embodiment of the invention illustrated inFIG. 43, the tubular member is provided with a pair of notches which are engaged by the holder member. Since the embodiment of the invention illustrated inFIG. 43 is similar to the embodiment of the invention illustrated inFIGS. 40-42, similar terminology will be utilized to designate similar components.
• In the embodiment of the invention illustrated inFIG. 43, atubular member1130 has acylindrical passage1132 through which asuture1134 extends. Thetubular member1130 has a cylindricalouter side surface1136. Anotch1138 is formed midway betweenopposite end surfaces1140 and1142 on thetubular member1130. Thenotch1138 corresponds to thenotch1096 in the embodiment of the tubular member illustrated inFIG. 41.
• In accordance with a feature of the embodiment of the invention illustrated inFIG. 43, a pair ofnotches1146 and1148 are formed in the cylindricalouter side surface1136. Thenotches1146 and1148 are disposed on the right side (as viewed inFIG. 43) of thetubular member1130 while thenotch1138 is formed in the opposite or left side of the tubular member. Although thenotches1146 and1148 are located closer to the notch.1138 than they are to the end surfaces1140 and1142 of thetubular member1130, thenotch1146 is located approximately halfway between thenotch1138 and theend surface1140. Similarly, thenotch1148 is located approximately halfway between thenotch1138 and theend surface1142 of thetubular member1130.
• When thetubular member1130 is positioned in engagement with a holder member, in a manner similar to which thetubular member1074 is positioned in engagement with theholder member1072 inFIG. 42, flanges, corresponding to theflanges1108 and1110 on the holder member engage thenotches1146 and1148 on thetubular member1130. The presence of thenotches1146 and1148 retards undesired relative movement between thetubular member1130 and the holder member as the tubular member is inserted into the holder member, in the manner indicated schematically inFIG. 42 for thetubular member1074.
Embodiment of FIG.44
• In the embodiment of the invention illustrated inFIGS. 40-42, thetubular member1074 is resiliently deflected to form asingle bend portion1124 in the tubular member. In the embodiment of the invention illustrated inFIG. 44, a plurality of bend portions are formed in thetubular member1074. Since the embodiment of the invention illustrated inFIG. 44 is similar to the embodiment of the invention illustrated inFIGS. 40-42, similar terminology will be utilized to identify similar components.
• In the embodiment of the invention illustrated inFIG. 44, asuture retainer1152 is utilized to secure asuture1154 against movement relative to body tissue. Although thesuture1154 has been illustrated schematically inFIG. 44 as having slack, it is contemplated that at least a portion of thesuture1154 disposed between thesuture retainer1152 and a suture anchor, corresponding to thesuture anchor1082 in thebody tissue1078 ofFIG. 42, will be tensioned with a predetermined force. Therefore, a predetermined tension is maintained in thesuture1154 and thesuture retainer1152 is pressed against the body tissue with a predetermined force.
• Thesuture retainer1152 includes a holder orretainer member1158 which at least partially encloses atubular member1160. Theholder member1158 has a generally C-shaped configuration with arecess1162 in which thetubular member1160 is disposed. Therecess1162 has anopening1164 through which thesuture1154 extends.
• In the illustrated embodiment of the invention, thetubular member1160 is disposed almost entirely within therecess1162. Only a relatively insignificant portion of thetubular member1158 extends through theopening1164. If desired, thetubular member1160 could have a length such that theentire tubular member1160 is disposed in therecess1162. Alternatively, the length of thetubular member1160 could be such that opposite end portions of thetubular member1160 project a substantial distance through the opening to therecess1162.
• In accordance with a feature of this embodiment of the invention, a pair ofbend portions1168 and1170 are formed in thetubular member1160. By resiliently deflecting thetubular member1160 to form thebend portions1168 and1170, two portions of apassage1174 through thetubular member1160 are bent to grip thesuture1154. A pair ofnotches1176 and1178 are formed in thetubular member1160. Thenotches1176 and1178 have the same configuration as thenotch1096 and perform the same function as thenotch1096 ofFIG. 41.
• When thesuture retainer1152 is to be utilized to secure thesuture1134 relative to body tissue, thetubular member1160 is slid along thesuture1154 into engagement with theholder member1158. At this time, thetubular member1160 has a'straight or linear configuration corresponding to the configuration of thetubular member1074 ofFIG. 41. The tubular member is then bent at thenotches1176 and1178 so that axially opposite end portions of thetubular member1160 are disposed in abutting engagement with each other.
• Thetubular member1160 is moved into therecess1162 in the C-shapedholder member1158. This prevents thetubular member1160 from springing back from the bent or resiliently deflected condition ofFIG. 44 toward its original linear or straight configuration. As thetubular member1160 is resiliently deflected to form thebend portions1168 and1170, thepassage1174 is collapsed and thesuture1154 is firmly gripped at both of the bend portions. This results in the desired tension being maintained in thesuture1154 and in theholder member1158 being pressed against body tissue with a desired force.
• Once thetubular member1160 has been positioned in theholder member1158, in the manner illustrated schematically inFIG. 44, both the holder member and tubular member may be plastically deformed by cold flowing the material of the holder member and the tubular member. Alternatively, just the material of thetubular member1160 may be plastically deformed. The material of thetubular member1160 andholder member1158 or just the material of thetubular member1160 may be deformed by force application members which apply force against opposite sides of thesuture retainer1152 in the manner previously explained in conjunction with the embodiment of the invention illustrated inFIGS. 40-42.
• Theholder member1158 is formed of a single piece of biodegradable polymer, such as polycaperlactone. Similarly, thetubular member1160 is formed of a single piece of a biodegradable polymer. Of course other biodegradable polymers could be utilized if desired.
Embodiment of FIGS.45-47
• In the embodiment of the invention illustrated inFIGS. 40-44, a holder member having an open-ended recess is used to retain a resiliently deflected tubular member, through which the suture extends, in a bent configuration. In the embodiment of the invention illustrated inFIGS. 45-47, the holder member has a closed recess in which the resiliently deflected tubular member is received. Since the embodiment of the invention illustrated inFIGS. 45-47 is similar to the embodiment of the invention illustrated inFIGS. 40-44, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-44 could be used with the embodiment of the invention illustrated inFIGS. 45-47.
• A suture retainer1190 (FIG. 45) is utilized to position asuture1192 relative tobody tissue1194. In the illustrated embodiment of thesuture retainer1190, thesuture1192 is connected with asuture anchor1198 which engages thebody tissue1194. Thesuture anchor1198 may be embedded in body tissue, in the manner illustrated inFIG. 42 or may be disposed adjacent to a side of the body tissue opposite from thesuture retainer1190, in the manner illustrated schematically inFIG. 38. Thesuture anchor1198 may have any desired construction. Alternatively, thesuture anchor1198 may be omitted and thesuture1192 connected with body tissue in any desired manner. For example, thesuture1192 may be connected with the body tissue in the manner illustrated inFIGS. 1 and 26 if desired. If desired, a suture retainer, having the construction of any one of the suture retainers disclosed herein, could be utilized in place of thesuture anchor1198.
• Thesuture retainer1190 includes a holder orretainer1202 and a tubular member1204 (FIG. 46). Theholder1202 includes a generally cylindrical main orcontainer section1208 and acircular cover section1210. It should be understood that themain section1208 andcover section1210 could have a different configuration if desired. For example, themain section1208 andcover section1210 could have rectangular configurations. Alternatively, either themain section1208 or thecover section1210 could have a circular configuration and the other section could have a rectangular configuration.
• It is believed that it may be preferred to construct theretainer1190 with a spherical configuration. If this was done, thecover section1210 would have an outer side surface which would form a portion of a sphere. Themain section1208 would have an outer side surface which would form the remainder of the sphere, that is the portion of the sphere not defined by thecover section1210.
• Themain section1208 of theholder1202 includes acircular base1214 which engages the body tissue1194 (FIG. 45). Acylindrical wall1216 extends upward (as viewed inFIGS. 45-47) from thebase1214 and is coaxial with the base. Thewall1216 is formed in a plurality ofsections1218,1220,1222 and1224 (FIG. 45). The sections1218-1224 of thewall1216 are resiliently deflectable relative to thebase1214.
• The arcuate sections1218-1224 (FIG. 45) of thewall1216 cooperate with thebase1214 to form a cylindrical recess or chamber1230 (FIGS. 46 and 47) in which thecylindrical tubular member1204 is disposed. Thetubular member1204 has anupper end portion1232 which is received in acylindrical socket1234 formed in thecover section1210. A cylindricallower end portion1236 of thetubular member1204 is received in acylindrical socket1238 formed in thebase1214 of themain section1208 of theholder1202. The upper andlower end portions1232 and1236 of thetubular member1204 could be connected with thecover section1210 and base1214 in a different manner if desired.
• Thetubular member1204 has a construction which is generally similar to the construction of thetubular member1074 ofFIG. 41. However, thetubular member1204 is provided with a plurality of notches to promote the formation of a plurality of bends in the tubular member. Thus, thetubular member1204 has acentral notch1242 which facilitates a formation of a bend1244 (FIG. 46) in a central portion of the initially straight tubular member.
• In addition, thetubular member1204 has an upper (as viewed inFIG. 46)notch1246 which promotes the formation of abend1248 adjacent to thecover section1210. Similarly, alower notch1250 promotes the formation of abend1252 adjacent to thebase1214 of themain section1208 of theholder1202. Thesuture1192 extends through acylindrical passage1256 formed in thetubular member1204.
• Although thetubular member1204 has been illustrated inFIG. 46 in a partially bent configuration, it should be understood that thetubular member1204 initially has a linear configuration, similar to the linear configuration of thetubular member1074 ofFIG. 41. When force is applied against thecover section1210, urging the cover section toward thebase1214 of themain section1208, thebends1244,1248 and1252 begin to form in the tubular member1204 (FIG. 46). Thenotches1242,1246 and1250 promote the formation of thebends1244,1248 and1252 at predetermined locations along the length of thetubular member1204 to impart a zig-zag configuration to the tubular member.
• Although it is preferred to utilizenotches1242,1246 and1250 to promote the formation of thebends1244,1248, and1252 at predetermined locations along the length of thetubular member1204, the tubular member could be weakened at preselected locations in other ways if desired. For example, the thickness of the side wall of thetubular member1204 could be reduced in areas where it is desired to have thebends1244,1248 and1252 formed.
• When thesuture retainer1190 is to be utilized to secure thesuture1192 relative to thebody tissue1194, thesuture1192 is moved into a slot1260 (FIG. 45) in themain section1208 of thesuture retainer1190. Theslot1260 extends from a cylindricalouter side surface1262 into a the center of thesocket1238 in the central portion of abase1214.
• Theslot1260 enables theholder1202 to be moved from a location spaced from thesuture1192 to a location in engagement with the suture and thebody tissue1194 without sliding theholder1202 along the suture. Thus, theholder1202 can be moved in a direction transverse to a longitudinal central axis of thesuture1192 into engagement with the suture at a location along the length of the suture immediately adjacent to thebody tissue1194. This facilitates positioning of theholder1202 relative to thebody tissue1194 without sliding the holder along thesuture1192.
• Theholder1202 is pressed against the body tissue with a predetermined force while thesuture1192 is tensioned with a predetermined force. If desired, theslot1260 could be omitted. If this was done, the suture would extend through a hole in thebase1214.
• Thetubular member1204 is then slid along thesuture1192 into engagement with theholder1202. As this occurs, thetubular member1204 has a straight or linear configuration, corresponding to the straight configuration of thetubular member1074 ofFIG. 41. Thelower end portion1236 of thetubular member1204 is moved along thesuture1192 toward theholder1202 with the suture extending through thepassage1256 in thetubular member1204. The lower orleading end portion1236 of thetubular member1204 is moved through therecess1230 in theholder1202 into thesocket1238 in thebase1214 of theholder1202.
• Thecover section1210 is then positioned relative to thesuture1192. Aslot1266 extends from a frustroconical peripheral surface1268 (FIG. 46) on thecover section1210 to the center of thesocket1234 in the central portion of the cover section (FIG. 45). Theslot1266 enables thecover section1210 to be positioned adjacent to the upper or trailingend portion1232 of thetubular member1204 without being slid along thesuture1192. Thus, thecover section1210 can be moved in a direction transverse to the longitudinal central axis of thesuture1192 into engagement with the suture at a location disposed immediately adjacent to and above (as viewed inFIG. 46) theupper end portion1232 of thetubular member1204. Thecover section1210 is then moved downward to position theupper end portion1232 of thetubular member1204 in thesocket1234.
• When thelower end portion1236 of thetubular member1204 is initially positioned in the socket1238.in theholder1202 and theupper end portion1232 of the tubular member is initially positioned in thesocket1234 in thecover section1210, thetubular member1204 has a straight or linear configuration. This results in thecover section1210 being disposed above (as viewed inFIG. 46) theholder1,202.
• To resiliently deflect thetubular member1204 from its initial straight configuration and to form thebends1244,1248 and1252 in the tubular member, thecover section1210 is pushed axially downward toward theholder1202 while a predetermined tension is maintained in thesuture1192. Columnar loading of thetubular member1204 increases as the axially downward force applied against thecover section1210 increases. When a predetermined force has been transmitted from the cover section to thetubular member1204 and from the tubular member to theholder1202 andbody tissue1194, the tubular member begins to buckle adjacent to thenotch1242 to initiate formation of thebend1244.
• The continued application of an increasing axial force to thecover section1210 results in buckling of thetubular member1204 adjacent to thenotches1246 and1250 to initiate formation of thebends1248 and1252. As thebend1244 and, subsequently, thebends1248 and1252 begin to form, thetubular member1204 andpassage1256 are deflected to a zig-zag configuration. Thecover section1210 is then moved downward (as viewed inFIG. 46) toward themain section1208 of theholder1202. While this is occurring, theholder1202 is being pressed against thebody tissue1194 with a predetermined force and a predetermined tension is maintained in thesuture1192.
• As thetubular member1204 continues to buckle under columnar loading, the frustroconical peripheral surface1268 (FIG. 46) on thecover section1210 moves into engagement with radially inward and downward slopingcam surfaces1274,1276,1278, and1280 on thesections1218,1220,1222 and1224 of the wall1216 (FIG. 45). The force applied against the sections1218-1224 of thewall1216 by thesurface1268 of thecover section1210 resiliently deflects the wall sections1218-1224 radially outward to increase the size of anopening1284 to therecess1230.
• As thecover section1210 continues to move downward, as viewed inFIG. 46, the cover section moves into therecess1230. As this occurs, the sections1218-1224 of thewall1216 resiliently snap back to their initial positions. When the sections1218-1224 of thewall1216 have moved back to their initial positions,retainer surfaces1288 on upper end portions of the sections1218-1224 of thewall1216 move into engagement with an upper (as viewed inFIG. 47)side surface1292 of thecover section1210 to latch thecover section1210 in place. This results in thecover section1210 being held against upward (as viewed inFIG. 47) movement relative to the main-section1208 of theholder1202. Therefore, thecover section1210 cooperates with thebase1214 of themain section1208 of theholder1202 to retain thetubular member1204 in the fully bent, zig-zag configuration illustrated inFIG. 47.
• As thetubular member1204 is resiliently deflected from its initial straight configuration through the partially bent configuration ofFIG. 46 to the fully bent zig-zag configuration ofFIG. 47, thepassage1256 through thetubular member1204 collapses and grips thesuture1192. The relatively sharp bend1244 (FIG. 47) in thetubular member1204 results from pressing the outer side surface on the portion of the tubular member disposed above (as viewed inFIG. 46) thenotch1242 against a portion of the outer side surface of the tubular member disposed below thenotch1242. The relativelysharp bend1244 results in thesuture1192 being securely gripped by the collapsed portion of thepassage1256 extending through thebend1244. In addition, the collapsed portions of thepassage1256 through thebends1248 and1252 securely grip thesuture1192.
• Once thetubular member1204 has been resiliently deflected to the bent configuration ofFIG. 47 and thecover section1210 firmly latched in place by the sections1218-1224 of thewall1216, thesuture1192 is securely gripped to maintain a predetermined tension in the portion of the suture extending between thesuture retainer1190 and the anchor1198 (FIG. 45). At this time, a predetermined force is transmitted from theholder1202 to thebody tissue1194. If desired, a force distribution member, similar to thebutton602 ofFIG. 26, could be positioned between themain section1208 of theholder1202 and thebody tissue1194 to distribute the force transmitted from the holder to the body tissue over a relatively large area. Alternatively, themain section1208 of theholder1202 could be formed with a circular flange which extends radially outward from thebase1214 to increase the surface area on thebody tissue1194 engaged by thesuture retainer1190.
• Although only a single section of thesuture1192 has been illustrated inFIGS. 45-47 as extending through themain section1208,tubular member1204, andcover section1210, two or more sections of the suture could extend through thesuture retainer1190 if desired. For example, two sections of thesuture1192 could extend through themain section1208,tubular member1204, andcover section1210 of thesuture retainer1190 if desired. The two sections of thesuture1192 would extend through thesuture retainer1190 in much the same manner as in which twosections66 and68 of thesuture52 extend through themain section704 of thesuture retainer700 ofFIG. 32.
• After thetubular member1204 has been resiliently deflected to the fully bent condition ofFIG. 47 and thecover section1210 latched in place by the sections1218-1224 of thewall1216, thesuture retainer1190 may be plastically deformed to further ensure a secure grip on thesuture1192. While thesuture retainer1190 is being pressed against thebody tissue1194 with a predetermined force and while the portion of thesuture1192 disposed between the anchor1198 (FIG. 45) and thesuture retainer1190 is tensioned with a predetermined force, a pair of force application members, corresponding to theforce application members340 and342 ofFIG. 18, may be pressed against opposite sides of thesuture retainer1190. The force applied against thesuture retainer1190 by the force application members plastically deforms the material of the suture retainer.
• The plastic deformation of thesuture retainer1190 is effective to cause cold flowing of material of the suture retainer. Thus, the force application members are effective to apply a predetermined force against theouter side surface1262 of thesuture retainer1190 to cause flowing of the material of the suture retainer at a temperature below a transition temperature range for the material of the suture retainer. The force applied against thesuture retainer1190 by the force application members is effective to cause cold flowing of the material of both theholder1202 and thetubular member1204.
• Thesuture retainer1190 is plastically deformed by the application of a predetermined force of a predetermined period of time against a suture retainer. As this occurs, the material of thetubular member1204 cold flows around thesuture1192 and is bonded with the material of the suture. The manner in which the material of thetubular member1204 bonds with thesuture1192 is the same as is illustrated schematically inFIGS. 4 and 5. The temperature at which the material of thetubular member1204 is plastically deformed and cold flows under the influence of force applied against thesuture retainer1190 by force application members, is close to the temperature of thebody tissue1194. This temperature is below the transition temperature for the material of thesuture retainer1190.
• Thesuture retainer1190 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer1190 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer1190 could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. It is also contemplated that thesuture retainer1190 could be formed of other biodegradable or bioerodible copolymers if desired.
• Although it is preferred to form thesuture retainer1190 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, thesuture retainer1190 could be formed of an acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer1190 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• It is preferred to effect cold flowing of the material of thesuture retainer1190 without the addition of heat. However, it is contemplated that thesuture retainer1190 could be heated to a temperature which is somewhat above the temperature of thebody tissue1194. If desired, heat could be transmitted to the suture retainer through the force application members utilized to effect cold flowing of the material of thesuture retainer1190. Although thesuture retainer1190 may be heated, the suture retainer would be maintained at a temperature below the transition temperature for the material of the suture retainer. Alternatively, the suture retainer could be heated to a temperature in the transition temperature range for the suture retainer.
• Thesuture1192, like thesutures1076,1134 and1154 ofFIGS. 40-44, may be of natural or synthetic materials. The sutures ofFIGS. 41-47 may be monofilament or may be formed of a plurality of interconnected filaments. The sutures ofFIGS. 41-47 may be biodegradable or non-biodegradable. It may be preferred to form the sutures ofFIGS. 41-45 of the same material as the associated suture retainers. However, the sutures could be formed of a material which is different than the materials of the associated suture retainers.
• In the embodiment of the invention illustrated inFIGS. 45, 46 and47, theholder1202 is formed separately from thetubular member1204. Thus, themain section1208 andcover section1210 of theholder1202 are formed separately from thetubular member1204. However, it is contemplated that thetubular member1204 and thecover section1210 andmain section1208 of theholder1202 could be formed as one piece. Alternatively, thetubular member1204 could be formed as one piece with just thecover section1210 or just themain section1208 of theholder1202. If thecover section1210 andmain section1208 of theholder1202 are integrally formed as one piece with thetubular member1204, thepassage1256 through thetubular member1204 would extend through thecover section1210 andmain section1208 of theholder1202. This would result in theholder1202 andtubular member1204 being moved together along thesuture1192 toward thebody tissue1194.
• When thecover section1210 andmain section1208 of theholder1202 are integrally formed as one piece with thetubular member1204, it may be desired to form a slot which extends through theholder1202 andtubular member1204 to a central axis of the tubular member. This would enable the suture retainer to be moved into engagement with thesuture1192 without first threading or inserting the suture through a passage extending through both theholder1202 andtubular member1204. The slot in the integrally formedtubular member1204 andholder1202 would enable thesuture retainer1190 to be positioned in engagement with thesuture1192 by moving the suture retainer transverse to a longitudinal central axis of thesuture1192. As this occurs, the suture would move through the aligned slots in theholder1202 andtubular member1204 to a position in which the longitudinal central axis of thesuture1192 is coincident with the longitudinal central axis of thetubular member1204. When such a slot is utilized, it is believed that the cold flowing of the material of thesuture retainer1190 by the application of force to the suture retainer while pressing theholder1202 against thebody tissue1194 with a predetermined force and maintaining a predetermined tension in the portion of thesuture1192 disposed between the suture retainer and theanchor1198 may be particularly advantageous.
• In the embodiment of the invention illustrated inFIGS. 45-47, thewall1216 is formed by a circular array of wall sections1218-1224. It is contemplated that a number of wall sections greater than the illustrated number or less than the illustrated number could be utilized if desired. It is also contemplated that the size of the slots between the wall sections1218-1224 could be increased. If desired, one or more of the wall sections1218-1224 could be omitted. For example, the diametricallyopposite wall sections1220 and1222 could be eliminated. This would open up therecess1230 and facilitate movement of body tissue into the recess.
Embodiment of FIGS.48-52
• In the embodiment of the invention illustrated inFIGS. 40-47, thesuture retainers1070,1152, and1190 all utilize a tubular member which partially encloses the suture. In the embodiment of the invention illustrated inFIGS. 48-52, one portion of a suture retainer is resiliently deflected and presses the suture against another portion of the suture retainer. Since the embodiment of the invention illustrated inFIGS. 48-52 is similar to the embodiment of the invention illustrated inFIGS. 40-47, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of any one of the embodiments of invention illustrated inFIGS. 1-47 may be used with any of the other embodiments of the invention illustrated inFIGS. 48-52.
• A suture retainer1300 (FIG. 52) is utilized to secure asuture1302 against movement relative to body tissue. It should be understood that although body tissue has not been illustrated schematically inFIG. 52, a predetermined force is transmitted from thesuture retainer1300 to the body tissue. In addition, a predetermined tension is maintained in a portion of thesuture1302 extending between thesuture retainer1300 and an anchor corresponding to theanchor1082 ofFIG. 42. However, it should be understood that thesuture1302 could be connected with body tissue in a manner other than the use of a suture anchor. For example, thesuture1302 could be connected with body tissue in the manner illustrated schematically inFIGS. 1, 9,26,36,38, and/or39 herein.
• Thesuture retainer1300 includes a holder member1306 (FIGS. 48 and 49) and a resilient member1308 (FIGS. 50 and 51). Thesuture1302 is wrapped around the resilient member1308 (FIGS. 50 and 51). As thesuture1302 is wrapped around theresilient member1308, a plurality of bends are formed in the suture. As turns of the suture are wrapped around theresilient member1308, loops are formed in thesuture1302 around theresilient member1308 in the manner illustrated inFIG. 50. A greater or lesser number of loops could be provided in thesuture1302 if desired.
• In the embodiment of the invention illustrated inFIGS. 48-52, only a single section of thesuture1302 is wrapped around the resilient member1308 (FIGS. 50 and 51). However, a plurality of sections of thesuture1302 could be wrapped around theresilient member1308 if desired. For example, two sections of thesuture1302 could be wrapped around theresilient member1308 in much the same manner as in which twosections66 and68 of thesuture52 are wrapped around thesuture retainer50 inFIG. 1.
• Theresilient member1308 has a generally C-shaped configuration. The resilient member has anopening1310 to a generallycircular recess1312. A pair ofactuator members1316 and1318 (FIGS. 50 and 51) are disposed adjacent to opposite sides of theopening1310. By manually applying force against theactuator members1316 and1318, theresilient member1308 can be deflected to decrease the size of the opening and the diameter of the generally circularresilient member1308.
• Theresilient member1308 includes a generallyrectangular body section1322 and anarcuate rim section1324 which projects radially outward from thebody section1322. Theactuator members1316 and1318,body section1322 andrim section1324 of theresilient member1308 are integrally molded as one piece.
• The holder member1306 (FIGS. 48 and 49) has anannular body section1328 which defines a circularcentral opening1330. Theannular body section1328 has an arcuate radially inner side surface1334 (FIG. 49) which faces inwardly toward the center of theholder member1308 and defines anannular groove1336. The illustratedbody section1328 has a generally rectangular cross sectional configuration, as viewed inFIG. 49. However, it is contemplated that the body section could be formed with a generally parabolic cross sectional configuration, as viewed inFIG. 49, in order to minimize interference with adjacent body tissues. In fact, thebody section1328 could be formed with a circular cross sectional configuration, as viewed inFIG. 49.
• When theresilient member1308 is in its initial or undeflected condition, thebody section1322 of the resilient member has an outside diameter which is greater than the diameter of thecircular opening1330 formed in theholder member1306. In addition, therim section1324 has a maximum outside diameter which is greater than the diameter of thegroove1336 in the holder member.
• Once thesuture1302 has been wrapped around theresilient member1308, in the manner illustrated schematically inFIGS. 50 and 51, theactuator members1316 and1318 are moved together to close theopening1310. As theactuator members1316 and1318 move toward each other, theresilient member1308 is resiliently deflected.
• The resilient deflection of themember1308 decreases the outside diameter of therim section1324 to a diameter which is slightly less than the diameter of the opening1330 (FIG. 48) in thebody section1328 of theholder member1306. Theresilient member1308 is then moved into axial alignment with theholder member1306. When theresilient member1308 andholder member1306 are in a coaxial relationship, theresilient member1308 is moved into theopening1330 in theholder member1306. As theresilient member1308 is moved into theopening1330 in theholder member1306, theactuator members1316 and1318 are held in abutting engagement with each other to close the opening1310 (FIG. 50) and maintain theresilient member1308 in a resiliently deflected condition in which the member has an outside diameter which is slightly less than the diameter of theopening1330.
• When theresilient member1308 has been moved into theopening1330 in thebody section1328, therim section1324 of theresilient member1308 is aligned with the groove1336 (FIG. 49) in theholder member1308. Theactuator members1316 and1318 are then released. This results in expansion of theresilient member1308 back toward the free or unrestrained condition ofFIG. 50. However, thegroove1336 has a diameter which is less than the diameter of the unrestrained rim section1324 (FIG. 50). Therefore, therim section1324 presses against theinner side surface1334 of thegroove1336 to hold theresilient member1308 in a deflected condition.
• As was previously mentioned, thesuture1302 is wrapped around the resilient member1308 (FIG. 50). Therefore, when theresilient member1308 expands into thegroove1336 in theholder member1306, therim section1324 on the resilient member is effective to clamp the turns formed in thesuture1302 against theinner side surface1334 of theholder member1306. This clamping action results in thesuture1302 being firmly gripped between the outer side surface of therim section1324 and theinner side surface1334 of thegroove1336. The clamping action between theresilient member1308 and theholder member1306 secures the suture against movement relative to thesuture retainer1300, body tissue against which thesuture retainer1300 is pressed, and an anchor with which thesuture1302 is connected.
• In the embodiment of the invention illustrated inFIGS. 48-52, thesuture1302 is wrapped for a plurality of turns around aresilient member1308. If desired, thesuture1302 could be wrapped for a single turn around theresilient member1308. Of course, a greater number of turns of thesuture1302 could be provided around theresilient member1308 if desired.
• When thesuture retainer1300 is to be positioned relative to body tissue, it is contemplated that theholder member1306 will be moved along thesuture1302 into engagement with the body tissue. Thesuture1302 will then be wrapped around theresilient member1308. Theresilient member1308 will then be moved along thesuture1302 toward theholder member1306. As theresilient member1308 is slid along thesuture1302 toward theholder member1306, the turns of the suture around the resilient member will slide along the surface of the resilient member. This results in movement of the bends formed in thesuture1302 by wrapping the suture around theresilient member1308 moving along the suture toward the body tissue andholder member1306 with theresilient member1308.
• It is contemplated that theholder member1306 will be pressed against the body tissue with a predetermined force and that a predetermined tension will be provided in thesuture1302 as theresilient member1308 is moved into theopening1330 in theholder member1306. The predetermined tension will be maintained in thesuture1302 and theholder member1306 will be pressed against the body tissue with the predetermined forces as therim section1324 on theresilient member1308 is moved into alignment with thegroove1336 in theholder member1306. The predetermined tension in thesuture1302 and the predetermined force to be transmitted between theholder member1306 and the body tissue as theactuator members1316 and1318 are released enable theresilient member1308 to radially expand and clamp thesuture1302 against theside surface1334 of thegroove1336.
• In the embodiment of the invention illustrated inFIGS. 48-52, theholder member1306 is formed as a continuous annular ring. Therefore, the ring must be moved along thesuture1302 to position the ring relative to the body tissue. It is contemplated that a radial slot could be provided through theannular holder member1306. The radial slot in theholder member1306 enables the holder member to be positioned adjacent to the body tissue and then moved transversely to thesuture1302 to position the suture in theopening1330 in theholder member1306. Thus, the slot in theholder member1306 would allow the holder member to be positioned relative to body tissue in much the same manner as in which the slot1260 (FIGS. 46 and 47) enables themain section1208 of theholder1202 to be positioned relative to body tissue.
• In the embodiment of the invention illustrated inFIGS. 48-52, asingle rim section1324 is provided on thebody section1322 of the resilient member1308 (FIGS. 50 and 51). However, it is contemplated that a plurality of axially spaced apart circular rim sections having the same configuration as therim section1324 could be formed on thebody section1322. Of course, if a plurality ofrim sections1324 were provided on theresilient member1308, a plurality ofgrooves1336 would be formed in thebody section1328 of the holder member1306 (FIGS. 48 and 49). By providing a plurality of rim sections on theresilient member1308 and a plurality of grooves in theholder member1306, undulations would be formed in each of the turns of thesuture1302 around theresilient member1308. A clamping action would be provided between each of therim sections1324 on theresilient member1308 and each of thegrooves1336 in theholder member1306.
• After theresilient member1308 has been positioned in theopening1330 in the holder member1306 (FIG. 52) and while a predetermined tension is maintained in the portion of thesuture1302 between thesuture retainer1300 and an anchor in the body tissue and while a predetermined force is transmitted between theholder member1306 and the body tissue, thesuture retainer1300 is plastically deformed to increase the grip of the suture retainer on thesuture1302. Thus, while the suture retainer is being pressed against the body tissue with the predetermined force and a predetermined tension is maintained in the portion of the suture between the suture retainer and an anchor in the body tissue, a pair of force application members are pressed against opposite sides of thesuture retainer1300. The force applied against thesuture retainer1300 by the force application members is effective to plastically deform the material of the suture retainer.
• The plastic deformation of thesuture retainer1300 is effective to cause cold flowing of material of theholder member1306 andresilient member1308. Force is applied against thesuture retainer1300 by the force application members while the suture retainer is at a temperature below a transition temperature range for the material of the suture retainer. Thus, thesuture retainer1300 is plastically deformed while the suture retainer is at a temperature close to the temperature of the associated body tissue. This temperature is below the transition temperature for the material of thesuture retainer1300.
• It is contemplated that axially directed forces may be applied against axially opposite ends of thesuture retainer1300 to effect the plastic deformation and cold flowing of the material of the suture retainer. However, it is also contemplated that radially directed forces could be applied against thesuture retainer1300 to effect plastic deformation and cold flowing of the material of the suture retainer.
• If force is applied against axially opposite end portions of thesuture retainer1300 to effect the cold flowing of the material of the suture retainer, it is contemplated that force application members similar to those illustrated inFIG. 3 herein could be utilized. Alternatively, if radially directed force is to be applied against thesuture retainer1300 to effect a cold flowing of the material of the suture retainer, force application members similar to those illustrated inFIG. 18 herein could be utilized.
• Thesuture retainer1300 may be formed of a many different materials. However, it is believed that it will be preferred to form thesuture retainer1300 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer1300 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 retainer1300 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, the suture retainer could be formed of an acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer1300 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• It is preferred to effect cold flowing of the material of thesuture retainer1300 without the addition of heat. However, it is contemplated that thesuture retainer1300 could be heated to a temperature which is somewhat above the temperature of the body tissue. If desired, heat could be transmitted to the suture retainer through the force application members. Although thesuture retainer1300 may be heated, the suture retainer would be maintained at a temperature below the transition temperature for the material of the suture retainer. Alternatively, thesuture retainer1300 could be heated into its transition temperature range and plastically deformed by hot flowing of the material of the suture retainer rather than cold flowing of the material.
• In the various embodiments of the invention illustrated herein, the suture, such as thesuture1302 ofFIG. 52, is formed of a monofilament which is biodegradable. However, it is contemplated that the sutures of any one of the embodiments of the invention illustrated herein, such as thesuture1302, could be formed of a plurality of interconnected filaments. These interconnected filaments could be either biodegradable or non-biodegradable. It may be preferred to form the suture of any one of the embodiments of the invention illustrated herein of the same material as the associated suture retainer. Thus, thesuture1302 ofFIG. 52 could be formed of the same material as thesuture retainer1300. However, thesuture1302 could be formed of a material which is different than the material of which thesuture retainer1300 is formed.
Embodiment of FIG.53
• In the embodiment of the invention illustrated inFIGS. 48-52, thesuture1302 is wrapped around aresilient member1308. In the embodiment of the invention illustrated inFIG. 53, the suture is wrapped around an axially tapered member and is enclosed by a holder member. Since the embodiment of the invention illustrated inFIG. 53 is generally similar to the embodiment of the invention illustrated inFIGS. 1-52, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-52 could be used with the embodiment of the invention illustrated inFIG. 53.
• A suture retainer1340 (FIG. 53) includes an axially taperedmember1342 and aholder member1344 which encloses the axially taperedmember1342 and a portion of asuture1346. Thesuture1346 is connected with a suture anchor (not shown) embedded in body tissue. Thesuture retainer1340 is effective to transmit a predetermined force to the body tissue. A predetermined tension is maintained in the portion of thesuture1346 disposed between thesuture retainer1340 and the suture anchor.
• Although thesuture1346 has been described as being connected with a suture anchor embedded in body tissue, it is contemplated that thesuture1346 could be connected with body tissue in a different manner if desired. For example, thesuture1346 could be connected with body tissue in the manner illustrated inFIGS. 1, 9,26,36,38, or39 herein. Alternatively, thesuture1346 could be connected with a second suture retainer which may have the same construction as thesuture retainer1340, the construction of any one of the suture retainers disclosed herein, or the construction of other known suture retainers.
• The axially taperedmember1342 has anouter side surface1350 which is formed as a portion of a right circular cone. Theouter side surface1350 of the axially taperedmember1342 extends between flat parallelcircular end surfaces1352 and1354. The end surfaces1352 and1354 are disposed in a coaxial relationship with each other and with theouter side surface1350 of the axially taperedmember1342. Theend surface1354 of the conical taperedmember1342 has a diameter which is smaller than the diameter of theend surface1352 of the taperedmember1342.
• Theholder member1344 has a cylindricalouter side surface1358. Theouter side surface1358 extends between aflat end surface1360 and acircular end surface1362. The end surfaces1360 and1362 extend parallel to each other and are disposed in a coaxial relationship. Theholder member1344 may have a configuration other than the cylindrical configuration illustrated inFIG. 53. For example, theholder member1344 may have a spherical configuration.
• Arecess1366 is formed in thecylindrical holder member1344. Therecess1366 is of the same size and configuration as the axially taperedmember1342. Therecess1366 is formed as a portion of a right circular cone. Therecess1366 has an axially taperedinner side surface1370 which has the same angle of taper as theouter side surface1350 of the taperedmember1342. If desired, the taper of theside surface1370 of therecess1366 could be slightly less than the taper in theouter side surface1350 on the axially taperedmember1342 to promote a wedging action between the axially tapered member and theholder member1344.
• In the embodiment of the invention illustrated inFIG. 53, the taper on theouter side surface1350 of the axially taperedmember1342 and the taper on theinner side surface1370 of therecess1366 in theholder member1344 is the same. The tapers on the axially taperedmember1342 and therecess1366 are relatively small and provide a self-holding action. Although many different tapers could be utilized, it is contemplated that it may be preferred to use a taper of the Morse taper series. Of course, other known tapers could be utilized if desired.
• Thesuture1346 is wrapped around the axially taperedmember1342 before the axially tapered member is inserted into theholder member1344. As thesuture1346 is wrapped around the axially taperedmember1342, a plurality of loops are formed in a spiral. This results in a continuous series of smooth arcuate bends, which are free of stress inducing discontinuities, being formed in thesuture1346 as it is wrapped around the axially taperedmember1342. After thesuture1346 has been wrapped around the axially taperedmember1342, the axially tapered member is inserted into therecess1366 in theholder member1344. If desired, a spiral groove may be formed in theouter side surface1350 of the axially taperedmember1342 to facilitate wrapping thesuture1346 around the axially taperedmember1342.
• A predetermined force is transmitted between theholder member1344 and the body tissue as the axially taperedmember1342 is moved into therecess1346 in the holder member. In addition, a predetermined tension is maintained in the portion of thesuture1346 extending between thesuture retainer1340 and a suture anchor embedded in the body tissue.
• The axially taperedmember1342 and theholder member1344 may be formed of a biodegradable or a bioerodible copolymer. Although it is believed that it will be preferred to use a biodegradable copolymer to form the axially taperedmember1342 andholder member1344, the axially tapered member and holder member could be formed of materials which are not biodegradable. Thesuture1346 is formed as a continuous filament of biodegradable material. However, thesuture1346 could be formed as a plurality of strands.
• In the embodiment of the invention illustrated inFIG. 53, only a single section of thesuture1346 is wrapped around the axially taperedmember1342. However, a plurality of sections of thesuture1346 could be wrapped around the axially taperedmember1342 if desired. For example, two sections of thesuture1346 could be wrapped around the axially taperedmember1342 in the same direction, in much the same manner as in which twosections66 and68 of thesuture52 are wrapped in the same direction around thebody184 of thesuture retainer190 ofFIG. 9. Alternatively, two sections of thesuture1346 could be wrapped around the axially taperedmember1342 in opposite directions, in much the same manner as in which twosections66 and68 of thesuture52 are wrapped in opposite directions around theconical body242 of thesuture retainer244 ofFIG. 13. If desired, grooves, corresponding to thegroove194 ofFIG. 9 or thegrooves258 and260 ofFIG. 13, could be provided in the axially tapered member1342 (FIG. 53).
Embodiment of FIG.54
• In the embodiment of the invention illustrated inFIG. 54, asuture retainer1380 is formed by an externally threadedmember1382 and an internally threadedholder member1384. The externally threadedmember1382 and theholder member1384 cooperate to secure asuture1386 against movement relative to body tissue. It should be understood that one or-more of the features of the embodiments of the invention illustrated inFIGS. 1-53 could be used with the embodiment of the invention illustrated inFIG. 54.
• The externally threadedmember1382 has a helicalexternal thread convolution1390 which extends from aleading end portion1392 of the externally threadedmember1382 to a trailing or head end portion (not shown) of the externally threadedmember1382. If desired, a force transmission element, such as a manually engagable handle or a hexagonal head engagable by a suitable tool, may be provided on the trailing end portion of the externally threadedmember1382. If a manually engagable handle is provided, the handle could project outwardly of theexternal thread convolution1390 and have suitably knurled surfaces for manual engagement by a surgeon. Alternatively, the externally threadedmember1382 could have the configuration of any one or many known bolts.
• Theholder member1384 has aninternal thread convolution1396 which extends between flatannular end surfaces1398 and1400 on acylindrical body section1402 of theholder member1384. Although theexternal thread convolution1390 andinternal thread convolution1396 have been schematically illustrated inFIG. 54 as having sharply defined crests and roots, thethread convolutions1390 and1396 could have rounded crests and roots, similar to those found on Whitworth screw threads or British Association screw threads. It is contemplated that the roots and crests of the internal andexternal thread convolutions1396 and1390 could have rounded or continuously curving surface areas which define the entire thread convolutions or at least a major portion of the thread convolutions.
• Thesuture1386 may have a distal end portion connected with a suture anchor embedded in body tissue, in the same manner as in which thesuture1192 ofFIG. 45 is connected with thesuture anchor1198 embedded in thebody tissue1194. However, the suture1386 (FIG. 54) could be connected with body tissue in a different manner if desired. For example, thesuture1386 could be connected with body tissue in any one of the ways illustrated inFIGS. 1, 9,26,36, and38 herein. Of course, thesuture1386 could be connected with body tissue in a different manner if desired.
• When thesuture retainer1380 is to be utilized to secure thesuture1386 relative to body tissue, one or more sections of the suture are inserted through the internally threaded opening in theholder member1384. Theholder member1384 is then moved along the suture until theend surface1400 on the holder member is disposed in abutting engagement with the body tissue. Thesuture1386 is then tensioned with a predetermined force and theend surface1400 on theholder member1384 is pressed against the body tissue with a predetermined force.
• The externally threadedmember1382 is then moved into engagement with theholder member1384. As theexternal thread convolution1390 engages theinternal thread convolution1396, the externally threadedmember1382 is rotated about its central axis relative to theholder member1384. The interaction between theexternal thread convolution1390 andinternal thread convolution1396 causes the externally threadedmember1382 to move into theholder member1384. As this occurs, thesuture1386 is clamped between theexternal thread convolution1390 andinternal thread convolution1396.
• The trailing end portion (not shown) of the externally threaded member1382.is provided with a head end surface which projects radially outward from theexternal thread convolution1390. The head end surface moves into engagement with theend surface1398 on theholder member1384. When the head end surface on the trailing end portion of the externally threadedmember1382 has moved into abutting engagement with theend surface1398 on theholder member1384, the helical, axially upward (as viewed inFIG. 54) facing flank on theexternal thread convolution1390 is pressed firmly against the axially downward facing flank on theinternal thread convolution1396. The helical upward facing flank of theexternal thread convolution1390 and the helical downward facing flank of theinternal thread convolution1396 securely grip thesuture1386 with a clamping action at spaced apart locations along the length of thesuture1386. The head end surface may be disposed on a hexagonal head end portion of the externally threadedmember1382.
• If desired, space can be provided between the helical crest of theexternal thread convolution1390 and the helical root of theinternal thread convolution1396. Space can also be provided between the root of theexternal thread convolution1390 and the crest of theinternal thread convolution1396. This space would minimize any possibility of abrading thesuture1386. If this is done, thesuture1386 would be gripped by force transmitted between the helical flanks of theexternal thread convolution1390 andinternal thread convolution1396. Of course, rounding the crests and roots of the internal andexternal thread convolutions1396 and1390 would also minimize any possibility of abrading thesuture1386.
• In the embodiment of the invention illustrated inFIG. 54, only a single section of thesuture1386 extends throughholder member1384. However, a plurality of sections of thesuture1386 could extend through theholder member1384 if desired. For example, two sections of thesuture1386 could extend through theholder member1384 in much the same manner as in which twosections66 and68 of thesuture52 extend through thesuture retainer740 ofFIG. 34. If desired, a force distribution member having a plurality of openings, that is, one for each section of the suture, could be provided between theholder member1384 and body tissue. The force distribution member may have a construction similar to the construction of theforce distribution member910 ofFIG. 36.
• It is contemplated that the externally threaded member1382 (FIG. 54) andholder member1384 will be formed of a biodegradable or bioerodible polymer. However, the externally threadedmember1382 and internally threadedmember1384 could be formed of materials which are not biodegradable.
• Thesuture1386 is formed of a biodegradable material. Thesuture1386 may be formed as a monofilament or a plurality of interconnected filaments. Although it is believed that it will be preferred to form thesuture1386 of a material which is biodegradable, thesuture1386 could be formed of a material which is not biodegradable.
• Once the externally threadedmember1382 andholder member1384 have been interconnected in the manner previously described, it is contemplated that the material of thesuture retainer1380 may be plastically deformed to enhance the grip of the suture retainer on thesuture1386. Thus, while thesuture retainer1380 is being pressed against the body tissue with a predetermined force and while a predetermined tension is maintained in the portion of thesuture1386 disposed between thesuture retainer1380 and an anchor embedded in body tissue, a pair of force application members are pressed against opposite sides of the suture retainer in the manner indicated schematically inFIG. 34. The force applied against thesuture retainer1380 by the force application members plastically-deforms the material of the suture retainer.
• The plastic deformation of thesuture retainer1380FIG. 54) is effective to cause cold flowing of the material of the suture retainer. The force applied against the suture retainer by the force application members will, in all probability, be effective to cause a greater cold flowing of the material of theholder member1384 than of the externally threadedmember1382. The cold flowing of the material of theholder member1384 will result in a bonding of the material of the holder member and, to some extent at least, of the externally threadedmember1382 with thesuture1386 in the manner indicated schematically inFIG. 4.
• It is preferred to effect the cold flowing of the material of thesuture retainer1380 without the addition of heat. However, it is contemplated that thesuture retainer1380 could be heated to a temperature which is somewhat above the temperature of the body tissue. If desired, heat could be transmitted to the suture retainer through the force application members. Although thesuture retainer1380 may be heated, the suture retainer would be maintained at a temperature below the transition temperature of the material of the suture retainer.
• Under certain circumstances, it is believed that it may be desired to heat thesuture retainer1380 into the transition temperature range of the material forming the externally threadedmember1382 and theholder member1384. When this is done, the force application members will effect a hot flowing of the material of the suture retainer rather than a cold flowing of the material.
• In the embodiment of the invention illustrated inFIG. 54, a single section of thesuture1386 extends through the internally threaded opening in thebody section1402 of theholder member1384. However, it is contemplated that one or more sections of thesuture1386 could be wrapped around thebody section1402 of theholder member1384, in much the same manner as in which thesections66 and68 of thesuture52 are wrapped around thesuture retainer50 inFIG. 2. This would result in a plurality of sections of thesuture1386 extending through the internally threaded opening in thebody section1402 of theholder member1384.
Embodiment of FIGS.55 and56
• In the embodiment of the invention illustrated inFIGS. 40-47, atubular member1074,1130 or1204 is deflected to form bends in a suture and grip the suture. In the embodiment of the invention illustrated inFIGS. 55 and 56, the bends are formed in the suture by interdigitating extensions or fingers. Since the embodiment of the invention illustrated inFIGS. 55 and 56 is similar to the embodiments of the invention illustrated inFIGS. 1-54, similar terminology will be utilized to identify similar components. It should be understood that one or more features of the embodiments of the invention illustrated inFIGS. 1-54 may be used with the embodiment of the invention illustrated inFIGS. 55 and 56.
• Asuture retainer1410 includes aholder member1412. Theholder member1412 has a spherical configuration. Theholder member1412 includes left and right (as viewed inFIG. 55)sections1414 and1416. Thesections1414 and1416 have a generally hemispherical configuration. Thesections1414 and1416 are disposed on opposite sides of asuture1418. If desired, thesuture retainer1410 could have a configuration which is different than the illustrated spherical configuration. For example, thesuture retainer1410 could be provided with a flat side surface which is pressed against body tissue.
• Thesuture1418 is connected with an anchor (not shown) which is embedded in body tissue. Of course, as previously explained herein, thesuture1418 could be connected with body tissue in a different manner if desired. A predetermined tension is maintained in a portion of thesuture1418 disposed between thesuture retainer1410 and the anchor. In addition, a predetermined force is transmitted from the suture retainer to the body tissue.
• Thesuture1418 may have a distal end portion connected with a suture anchor embedded in body tissue, in the same manner as in which thesuture1192 ofFIG. 45 is connected with thesuture anchor1198 embedded in thebody tissue1194. However, the suture1418 (FIG. 55) could be connected with body tissue in a different manner if desired. For example, thesuture1418 could be connected with body tissue in any one of the ways illustrated inFIGS. 1, 9,26,36, and38 herein. Of course, thesuture1418 could be connected with body tissue in a different manner if desired.
• Thesection1414 of theholder member1412 is provided with a plurality of generally cylindrical fingers orprojections1422,1424, and1426 which extend into generallycylindrical recesses1428,1430 and1432 formed in thesection1416 of theholder member1412. Similarly, a plurality of generally cylindrical fingers orprojections1434 and1436 extend from thesection1416 of theholder member1412 into generallycylindrical recesses1438 and1440 formed in thesection1414 of theholder member1412. It is contemplated that the number and configuration of the projections from thesections1414 and1416 could be different than the specific number and configuration of projections illustrated inFIG. 55.
• Theprojections1434 and1436 from thesection1416 are interdigitated with or extend between theprojections1422,1424 and1426 from thesection1414. Thesuture1418 is coextensive with the outer side surfaces of theprojections1422,1424,1426,1434 and1436. This results in the portion of thesuture1418 disposed in thesuture retainer1410 having a serpentine configuration. The serpentine configuration of thesuture1418 results in the formation of a plurality of bends where the suture extends across outer end portions of the fingers orprojections1422,1424,1426,1434 and1436.
• The portion of thesuture1418 disposed in thesuture retainer1410 is firmly gripped between the fingers or projections and the side surfaces of the recesses in which the projections are disposed. Thus, a portion of thesuture1418 is firmly gripped between theprojections1424 and1426 from thesection1414 of theholder member1412 and the side surfaces of therecesses1428,1430 and1432 in thesection1416 of theholder member1412. Similarly, a portion of the suture is firmly gripped between theprojections1434 and1436 from thesection1416 and the side surfaces of therecesses1438 and1440 formed in thesection1414 of theholder member1412.
• A pair ofconnectors1450 and1452 (FIG. 56):are provided to interconnect thesections1414 and1416 of theholder member1412. Theconnector1450 includes alatch member1456 which extends from thesection1416 into arecess1458 formed in thesection1414. Thelatch member1456 has a shoulder which abuts a surface of therecess1458 to hold thesection1414 against movement relative to thesection1416.
• Similarly, theconnector1452 includes alatch member1462 which extends from thesection1414 into arecess1464 formed in thesection1416. Thelatch member1542 abuts a surface on therecess1464 to hold thesection1414 against movement relative to thesection1416 of theholder member1412.
• Although one specific type ofconnector1450 and1452 has been illustrated schematically inFIG. 56 to interconnect thesections1414 and1416 of theholder member1412, it should understood that other known types of connectors could be utilized if desired. For example, a circular band could be provided around the outside of thesuture retainer1410 to hold the twosections1414 and1416 against movement relative to each other.
• When thesuture retainer1410 is to be used to secure thesuture1418 relative to body tissue, a predetermined force is applied to thesuture1418 to tension the suture. The twosections1414 and1416 of theholder member1412 are pressed against body tissue with a predetermined force. The twosections1414 and1416 are moved to positions adjacent to opposite sides of thesuture1418 with thefingers1422,1424, and1426 on thesection1414 aligned with therecesses1428,1430, and1432 in thesection1416. In addition, thefingers1434 and1436 on thesection1416 are aligned with therecesses1438 and1440 in thesection1414. The twosections1414 and1416 are then pressed against each other to move thesuture1418 into therecesses1428,1430,1432,1438, and1440 in thesections1414 and1416. As this occurs, thelatch members1456 and1462 of theconnectors1450 and1452 snap into therecesses1458 and1464 with a latching action to fixedly interconnect the twosections1414 and1416 of theholder member1412.
• The twosections1414 and1416 of theholder member1412 may be formed of many different materials. However, it is believed that it will be preferred to form thesections1414 and1416 of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer1410 could be formed of polyethylene oxide terephthalate or polybutylene terephthalate. It is also contemplated that other biodegradable or bioerodible polymers could be utilized if desired.
• Although it is preferred to form thesuture retainer1410 of a biodegradable material, the suture retainer could be formed of a material which is not biodegradable. For example, the suture retainer could be formed of acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer1410 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• In order to obtain a firmer grip on thesuture1418 with thesuture retainer1410, the suture retainer may be plastically deformed after the twosections1414 and1416 of thesuture retainer1410 have been interconnected by theconnectors1450 and1452 (FIG. 56). While thesuture retainer1410 is being pressed against the body tissue with a predetermined force and a predetermined tension is maintained in the portion of thesuture1418 between the anchor and the suture retainer, a pair of force application members are pressed against opposite sides of the suture retainer. The force applied against thesuture retainer1410 by the force application members plastically deforms the material of the suture retainer.
• The plastic deformation of thesuture retainer1410 is effective to cause cold flowing of material of the suture retainer. Force is applied against thesuture retainer1410 at a temperature below a transition temperature range for the material of the suture retainer. The force application members which apply force against thesuture retainer1410 may have a configuration corresponding to the configuration of the force application members ofFIG. 3 or the force application members ofFIG. 18.
• It is preferred to effect cold flowing of the material of thesuture retainer1410 without the addition of heat. However, it is contemplated that thesuture retainer1410 could be heated to a temperature which is somewhat above the temperature of the body tissue with which the suture retainer is associated. If desired, heat could be transmitted to thesuture retainer1410 through the force application members which effect plastic deformation of thesuture retainer1410. Although thesuture retainer1410 may be heated, thesuture retainer1410 would be maintained at a temperature below the transition temperature for the material of the suture retainer. However, if desired, the suture retainer could be heated to a temperature in the transition temperature range for the material of the suture retainer.
• In the embodiment of the invention illustrated inFIGS. 55 and 56, a single section of the suture is gripped by thesuture retainer1410. However, it is contemplated that a plurality of sections of thesuture1418 could be gripped by thesuture retainer1410 if desired. For example, two sections of thesuture1418 could extend through thesuture retainer1410 in a side-by-side relationship. Alternatively, two separate sets of projections and recesses could be provided. If this was done, one section of thesuture1418 would extend along one set of projections and recesses and the second section of the suture would extend along the second set of projections and recesses.
Embodiment of FIGS.57 and58
• In the embodiment of the invention illustrated inFIGS. 57 and 58, a pair of cam members are utilized to secure a suture relative to body tissue. Since the embodiment of the invention illustrated inFIGS. 57 and 58 is similar to the embodiments of the invention illustrated inFIGS. 1-56, similar terminology will be utilized to identify similar components. It should be understood that one or more of the features of the embodiments of the invention illustrated inFIGS. 1-56 may be used with the embodiment of the invention illustrated inFIGS. 57 and 58.
• Asuture retainer1472 is utilized to secure asuture1474 against movement relative to body tissue. Thesuture retainer1472 includes aholder1476 which encloses a portion of thesuture1474. A portion of the suture disposed between thesuture retainer1472 and an anchor embedded in the body tissue is tensioned with a predetermined force. In addition, a predetermined force is transmitted from thesuture retainer1472 to the body tissue.
• Thesuture1474 may have a distal end portion connected with a suture anchor embedded in body tissue, in the same manner as in which thesuture1192 ofFIG. 45 is connected with thesuture anchor1198 embedded in thebody tissue1194. However, the suture1474 (FIGS. 57 and 58) could be connected with body tissue in a different manner if desired. For example, thesuture1474 could be connected with body tissue in any one of the ways illustrated inFIGS. 1, 9,26,36, and38 herein. Of course, thesuture1474 could be connected with body tissue in a different manner if desired.
• Theholder1476 includes a front panel1478 (FIG. 57) and a rear panel1480 (FIG. 58). A pair of mounting pins or bearingsections1484 and1486 extend between the front andrear panels1478 and1480. Thesuture1474 extends between the front andrear panels1478 and1480. Thesuture1474 is disposed midway between thepins1484 and1486.
• A left (as viewed inFIG. 58)cam member1490 is mounted on thepin1484. A right (as viewed inFIG. 58)cam member1492 is mounted on thepin1486. Thecam members1490 and1492 are rotatable relative to thepins1484 and1486. A suitable spring (not shown) is provided to urge thecam member1490 to rotate in a clockwise direction (as viewed inFIG. 58). Similarly, a suitable spring (not shown) is provided to urge thecam member1492 to rotate in a counterclockwise direction (as viewed inFIG. 58).
• Thecam member1490 has anose portion1496 withteeth1498. Similarly, thecam member1492 has anose portion1502 withteeth1504. Theteeth1498 on thecam member1490 mesh with theteeth1504 on thecam member1492. A portion of thesuture1474 is disposed in engagement with theteeth1498 and theteeth1504. Theteeth1498 and1504 or thecam members1490 and1492 press against thesuture1474 to impart a serpentine configuration to the suture.
• When thesuture retainer1492 is to be utilized to secure thesuture1474 against movement relative to body tissue1510 (FIG. 58), thesuture1474 is positioned between thecam members1490 and1492, in the manner indicated schematically inFIG. 58. Thesuture retainer1492 is then moved along thesuture1474 toward thebody tissue1510. At this time, thecam members1490 and1492 are loosely pressed against thesuture1474 by the biasing springs associated with the cam members. Theholder1476 is moved into engagement with the body tissue and pressed against the body tissue with a predetermined force. At the same time, thesuture1474 is tensioned with a predetermined force.
• Thesuture1474 is then released. The tension in the portion of the suture between thesuture retainer1472 and a suture anchor embedded in thebody tissue1510 causes thecam member1490 to tend to rotate in a clockwise direction about the mountingpin1484. Similarly, the force applied by thesuture1474 against thecam member1492 tends to rotate the cam member in a counterclockwise direction about the mountingpin1484. As this occurs, theteeth1498 and1504 on thenose portions1496 and1502 are pressed firmly against thesuture1474.
• Thesuture retainer1472 may be formed of many different materials. However, it is believed that it will be preferred to form thesuture retainer1472 of a biodegradable polymer. Thus, theholder1476,cam members1490 and1492, and the biasing springs (not shown) for thecam members1490 and1492 are formed of a biodegradable polymer. One biodegradable polymer which may be utilized is polycaperlactone. Alternatively, thesuture retainer1492 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 retainer1472 of a biodegradable material, the suture retainer could formed of a material which is not biodegradable. For example, the suture retainer could be formed of an acetyl resin, such as “Delrin” (trademark). Alternatively, thesuture retainer1472 could be formed of a para-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon” (trademark).
• Thesuture1474 may be formed of natural or synthetic materials. Thesuture1474 may be a monofilament or may be formed of a plurality of interconnected filaments. Thesuture1474 may be biodegradable or non-biodegradable. It may be preferred to form thesuture1474 of the same material as thesuture retainer1472. However, thesuture1474 could be formed of a material which is different than the material of the suture retainer.
• Once thesuture retainer1472 has gripped thesuture1474 while a predetermined force is being transmitted between theholder1476 and thebody tissue1510 and while the portion of the suture disposed between thesuture retainer1472 and a suture anchor embedded in the body tissue is tensioned with a predetermined force, thesuture retainer1472 may be plastically deformed to increase the grip of the suture retainer on the suture. A pair of force application members are pressed against opposite sides of thesuture retainer1472 to plastically deform the material of the suture retainer. The force transmitting members may have the same construction as the force transmitting members illustrated inFIG. 3 herein.
• The plastic deformation of thesuture retainer1472 is effective to cause cold flowing of material of the suture retainer. Thus, the force application members are effective to cause flowing of the material of thesuture retainer1472 at a temperature below a transition temperature range for the material of the suture retainer. The cold flowing of the material of thesuture retainer1472 enables the material of the suture retainer to bond to and obtain a firm grip on the suture in the manner illustrated schematically inFIG. 4. The cold flowing of the material of thesuture retainer1472 occurs at a temperature which is close to the temperature of thebody tissue1510 and below the transition temperature range of the material forming the suture retainer. However, if desired, thesuture retainer1472 could be heated into its transition temperature range before being plastically deformed.
Embodiment of FIG.59
• In the embodiments of the invention illustrated inFIGS. 1-58, various types of suture retainers for use in securing a suture relative to body tissue have been illustrated. The embodiment of the invention illustrated inFIG. 59 is not limited to any particular suture retainer construction. However, similar terminology will be utilized in describing the components of the embodiment of the invention illustrated inFIG. 59 as were previously utilized in connection with the embodiments of the invention illustrated inFIGS. 1-58.
• In the embodiment of the invention illustrated inFIG. 59, a relatively thick layer of tissue, designated by the numeral1520 is to be connected with a relatively thin layer of tissue, designated by thenumeral1522. Atissue fixation system1524 is utilized to interconnect the thick and thin layers of tissue. Thetissue fixation system1524 is located a precise distance from anend1526 of the thick layer oftissue1520 and anend1528 of thethin layer1522 of tissue. In the illustrated embodiment of the invention, thetissue fixation system1524 is located the same distance from theend1526 of the thick layer of tissue as in which the tissue fixation system is located from theend1528 of the thin layer of tissue. This results in the two layers of tissue growing together with a minimum of scarring. In addition, thetissue fixation system1524 holds thethick layer1520 andthin layer1522 of tissue against shifting relative to each other.
• If a staple or a loop-type suture was used to interconnect thethick layer1520 and thethin layer1522 of tissue, shifting would occur between the two layers of tissue. This shifting would occur inside of the loop formed by the suture or the staple. The shifting can result in excessive scarring and could result in a non-uniform repair of the tissue. The obtaining of a uniform repair of tissue is particularly important when interconnecting a conduit, such as a blood vessel, which has been severed. By using thetissue fixation system1524, shifting movement can not occur between the two layers of tissue being interconnected. This prevents one of the layers of tissue from being deflected into the path of flow of material, such as blood, through the conduit in a manner which restricts the conduit and subsequently results in a blockage.
• The specifictissue fixation system1524 illustrated inFIG. 59 includes asuture anchor1532 which is disposed in engagement with anouter side surface1534 of thethin layer1522 of tissue. Asuture1536 extends through both thethin layer1522 of tissue and thethick layer1520 of tissue. Thesuture1536 is disposed the same distance from theend1526 of the thick layer of tissue as it is located from theend1528 of thethin layer1522 of tissue. A suture retainer1538 is connected with a portion of thesuture1536 opposite from thesuture anchor1532.
• When thetissue fixation system1524 is to be utilized to repair body tissue, thethick layer1520 andthin layer1522 of body tissue are positioned in abutting engagement with each other. At this time, theends1526 and1528 of the thick andthin layers1520 and1522 of body tissue are disposed in precise alignment with each other. Thesuture anchor1532, with thesuture1536 connected thereto, may then be inserted through both thethick layer1520 of tissue and thethin layer1522 of tissue. Thesuture anchor1532 is positioned in engagement with theouter side surface1534 of the thin layer oftissue1522. Alternatively, thesuture anchor1532 could be embedded in the thin layer oftissue1532.
• It is contemplated that a suture anchor inserter having a construction similar to the construction disclosed in U.S. Pat. No. 5,948,002 will be utilized to move thesuture anchor1532 through the two layers of body tissue. The suture anchor may have the same construction and be positioned relative to the body tissue in the manner disclosed in U.S. Pat. No. 5,549,631 and/or U.S. Pat. No. 5,569,305. Of course other known suture anchor inserters could be used to position suture anchors having different constructions relative to thetissue1520 and1522 in a different manner if desired.
• Once thesuture1536 has been inserted through thethick layer1520 andthin layer1522 of tissue, asuture retainer1540 is moved along thesuture1536 into abutting engagement with anouter side surface1542 of thethick layer1520 of body tissue. Thesuture retainer1540 may have the same construction as thesuture retainer50 ofFIGS. 1-5. Alternatively, thesuture retainer1540 could have any one of the constructions illustrated inFIGS. 6-58. However, thesuture retainer1540 could have a different construction if desired. If desired, a force distribution member could be provided between thesuture retainer1540 and thethick layer1520 of body tissue.
• Thesuture1536 is then tensioned with a predetermined force which is a function of the size of thesuture1536. Thesuture retainer1540 is pressed against thethick layer1520 of body tissue with a predetermined force while the predetermined tension is maintained in the portion of thesuture1536 disposed between thesuture retainer1540 and thesuture anchor1532. While this tension is maintained, thesuture retainer1540 is secured to thesuture retainer1536.
• Once thesuture retainer1540 has been secured to thesuture retainer1536, it is contemplated that it may be desired to plastically deform thesuture retainer1540 to increase the grip of the suture retainer on thesuture1536. A pair of force application members may be pressed against opposite sides of thesuture retainer1540 to effect a cold flowing of material of the suture retainer. The cold flowing of the material of thesuture retainer1540 enables the material of thesuture retainer1540 to bond to and obtain a firm grip on thesuture1536. The cold flowing of the material of thesuture retainer1540 may occur at a temperature which is below the transition temperature of the material forming the suture retainer. Alternatively, thesuture retainer1540 may be heated to a temperature which is within its transition temperature range and then plastically deformed.
• Since thesuture1536 extends along a straight line through thethick layer1520 andthin layer1522 of tissue, there is no tendency for the one of the layers of tissue to shift relative to the other layer of tissue. The straight line application of force through thesuture1536 makes certain that the suture remains at a precise distance from theends1526 and1528 of thethick layer1520 andthin layer1522 of tissue.
• It is contemplated that a plurality of suture fixation systems, having the same construction as thesuture fixation system1524, will be provided at uniformly spaced apart locations along the ends of the thick and thin layers of tissue. The tissue fixation systems will be positioned predetermined distances apart in an array which extends along theends1526 and1528 of the thick andthin layers1520 and1522 of tissue. Each of the tissue fixation systems will be positioned the same distance from theends1526 and1528 of thethick layer1520 andthin layer1522 of tissue.
• For example, each of thetissue fixation systems1524 could be positioned exactly five millimeters from theend1526 of the thick layer of tissue and exactly five millimeters from theend1528 of thethin layer1522 of tissue. All of thetissue fixation systems1524 in the array of tissue fixation systems would be spaced the same distance from theends1526 and1528 of thethick layer1520 and thin layer of tissue. Of course, thetissue fixation systems1524 could all be positioned at a distance other than five millimeters from the ends of the thick andthin layers1520 and1522 of tissue.
• In the embodiment of the invention illustrated inFIG. 59, thetissue fixation system1524 includes asuture anchor1532 and asuture retainer1540. However, it is contemplated that a pair of suture retainers could be connected with opposite end portions of thesuture1536. Although it is believed that it will probably be preferred to provide suture retainers having the same construction at opposite end portions of thesuture1536, the suture retainers at opposite end portions of thesuture1536 could have different constructions.
• When the array oftissue fixation systems1524 have been positioned along theends1526 and1528 of the thick andthin layers1520 and1522 of tissue, aninner side surface1546 on thethick layer1520 of tissue will be disposed in abutting engagement with aninner side surface1548 on thethin layer1522 of tissue. Theinner side surfaces1546 and1548 on thethick layer1520 andthin layer1522 of tissue will be pressed together with the same force at each of thetissue fixation systems1524 disposed in the linear array of tissue fixation systems.
• It is contemplated that thethick layer1520 of tissue may have a tubular configuration and that thethin layer1522 of tissue may also have a tubular configuration. Theend1526 of thethick layer1520 of tissue would have a circular configuration. Similarly, theend1528 of thethin layer1522 of tissue would have a circular configuration. The thick andthin layers1520 and1522 of tissue would flare or extend radially outward to form an annular flange in which theends1526 and1528 of the thick and thin layers of tissue are held in precise alignment with each other by the circular array oftissue fixation systems1524.
• It should be understood that the specific and presently preferred embodiments of the invention illustrated herein are only examples of many different embodiments of the invention which are possible. In describing the presently preferred embodiments of the invention, similar terminology has been used to designate components which are similar in structure and function. The specific features of any one embodiment of the invention may be utilized in association with any of the other embodiments of the invention. For example, it is contemplated that any one of the suture retainers ofFIGS. 1-58 could be utilized in the tissue fixation system illustrated inFIG. 59.

Claims (22)

1. A method of securing a suture relative to body tissue comprising:

engaging a portion of the suture with a first member;

deforming the first member while the portion of the suture is engaged by the first member, wherein deforming the first member includes changing the configuration of the first member from a first configuration to a second configuration;

inserting the first member into a second member while the first member has the second configuration; and

retaining the first member in the second configuration.

2. A method as set forth inclaim 1 further comprising sliding the first member along the suture toward the body tissue while the suture is disposed in engagement with the first member.

3. A method as set forth inclaim 1, wherein retaining the first member in the second configuration includes applying force against the first member with the second member while the first member is disposed in the second member.

4. A method as set forth inclaim 1 wherein retaining the first member in the second configuration includes at least partially enclosing the first member with the second member.

5. A method as set forth inclaim 1 wherein inserting the first member into second member includes moving opposite end portions of the first member into the second member.

6. A method as set forth inclaim 5 wherein moving opposite end portions of the first member into the second member includes sliding the first member along the suture.

7. A method as set forth inclaim 1 wherein deforming the first member includes applying a force to opposite end portions of the first member.

8. A method as set forth inclaim 7 wherein applying a force to opposite end portions of the first member includes moving the opposite end portions of the first member toward each other to change the configuration of the first member from the first configuration to the second configuration.

9. A method as set forth inclaim 1 wherein deforming the first member includes plastically deforming the first member.

10. A method as set forth inclaim 9 wherein plastically deforming the first member is performed with the first member at a temperature below a transition temperature of material forming the first member.

11. A method as set forth inclaim 9 wherein plastically deforming the first member includes applying heat to the first member, wherein plastically deforming the first member is performed with the first member at a temperature below a transition temperature of material forming the first member.

12. A method as set forth inclaim 1 wherein the first member has first and second end portions, and deforming the first member to change the configuration of the first member from the first configuration to the second configuration includes moving the first and second end portions of the first member toward each other by deforming a portion of the first member disposed between the first and second end portions of the first member.

13. A method as set forth inclaim 1 further including plastically deforming material of at least one of the first and second members while the first member is in the second configuration and inserted in the second member.

14. A method as set forth inclaim 13 wherein plastically deforming material of at least one of the first and second members includes applying a force to at least one of the first and second members.

15. A method as set forth inclaim 13 wherein plastically deforming material of at least one of the first and second members is performed at a temperature below a transition temperature of material forming at least one of the first and second members.

16. A method as set forth inclaim 13 wherein plastically deforming at least one of the first and second members includes applying heat to at least one of the first and second members, wherein plastically deforming at least one of the first and second members is performed at a temperature below a transition temperature of material forming at least one of the first and second members.

17. A method as set forth inclaim 1 further including tensioning the suture and transmitting a predetermined force from the first member to the body tissue prior to performing said step of deforming the first member.

18. A method as set forth inclaim 1 wherein the first member is a tubular member having a passage which extends between opposite end portions of the tubular member, and deforming the first member includes gripping the suture with the tubular member by bending the tubular member at a location disposed between the opposite end portions of the tubular member.

19. A method as set forth inclaim 18 wherein bending the tubular member includes decreasing a distance between the opposite end portions of the tubular member.

20. A method as set forth inclaim 1, wherein inserting the first member into a second member while the first member has the second configuration includes inserting the first member into a recess of the second member.

21. A method of securing a suture relative to body tissue, comprising:

engaging a portion of the suture with a first member;

deforming the first member while the portion of the suture is engaged by the first member, including changing the configuration of the first member from a first configuration to a second configuration;

inserting the first member into a recess in a second member while the first member has the second configuration; and

retaining the first member in the second configuration by applying force against the first member with at least the second member while the first member is disposed in the recess in the second member.

22. A method of securing a suture relative to body tissue, comprising:

engaging a portion of the suture with a first member;

deforming the first member while the portion of the suture is engaged by the first member, including changing the configuration of the first member from a first configuration to a second configuration;

inserting the first member into a recess in a second member while the first member has the second configuration;

retaining the first member in the second configuration by applying force against the first member with at least the second member while the first member is disposed in the recess in the second member; and

plastically deforming material of at least one of the first and second members while the first member is in the second configuration and inserted in the second member, wherein plastically deforming material of at least one of the first and second members is performed at a temperature below a transition temperature of material forming at least one of the first and second members

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