This application is a continuation-in-part co-pending application 11/168173 entitled SUTURE WOUND CLOSURE, TISSUE APPROXIMATION, TISSUE SUPPORT, SUSPENSION AND/OR FIRATION filed on 28.2005, which is hereby incorporated by reference, AND which in turn claims priority from U.S. patent application 60/584927 filed on 30.6.2004, 35U.S. C.119(e), which is hereby incorporated by reference.
Drawings
The features of the invention believed to be novel are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify like elements, and in which:
FIG. 1 sets forth a side view of a completed suture assembly constructed in accordance with the present invention;
FIG. 2 sets forth a side view of the suture portion of the suture assembly of the present invention;
FIG. 3 sets forth a cross-sectional view of a schematic segment of a tissue-gripping portion of the present invention suture;
FIG. 4 sets forth a cross-sectional view of a tissue-grasping element (tissue-embedding element) prior to installation in a suture assembly;
FIG. 5 sets forth a front view of the tissue-gripping element of FIG. 4;
FIG. 6 sets forth a side view of the straight needle portion of the suture assembly of the present invention;
FIG. 7 sets forth a side view of the looper portion of the present invention suture assembly;
FIG. 8 sets forth a cross-sectional view of an alternate embodiment of a tissue-gripping element;
FIG. 9 sets forth a front view of the tissue-gripping element of FIG. 8;
FIG. 10 illustrates yet another alternative embodiment of the present invention, which provides a bi-directional suture;
FIG. 11 shows a perspective view of yet another alternative embodiment of the present invention;
FIGS. 12A and 12B set forth respective front and cross-sectional views of a tissue-gripping element constructed in accordance with the present invention having a generally conical and slotted configuration;
FIGS. 13A and 13B provide an elevational view and a cross-sectional view, respectively, of a tissue-gripping element defining a generally pentagonal taper;
14A and 14B present, respectively, an elevation view and a cross-sectional view of a tissue-gripping element defining a generally square cross-section;
FIGS. 15A and 15B present, respectively, an elevation view and a cross-sectional view of a tissue-gripping element defining a cross-section of four lobes (lobeds);
FIGS. 16A and 16B present, respectively, an elevation view and a cross-sectional view of a tissue-gripping element defining three lobed cross-sections;
FIGS. 17A and 17B show front and cross-sectional views, respectively, of a flat, disc-shaped tissue-gripping element;
FIG. 18 sets forth a side view of a suture portion constructed in accordance with the present invention and utilizing a plurality of knots for tissue-gripping elements;
FIG. 19 sets forth a side view of a complete suture assembly constructed in accordance with the present invention supporting a porous tissue bonding sleeve;
FIG. 20 sets forth a side view of a suture portion having tissue-gripping elements unevenly spaced;
FIG. 21 sets forth a partial cross-sectional side view of a suture portion constructed in accordance with the present invention and having a tissue-gripping element secured to the elongated filament of the suture assembly by a connection utilizing laser welding, ultrasonic welding or adhesive attachment;
FIG. 22 sets forth a partial cross-sectional side view of a suture portion constructed in accordance with the present invention and having a plurality of tissue-gripping elements formed by a molding or forging process;
FIG. 23 sets forth a partial cross-sectional side view of a suture portion constructed in accordance with the present invention and having a plurality of tissue engaging elements positioned by a plurality of integrally formed enlarged portions on the filament; and
FIG. 24 sets forth a side view of a suture portion constructed in accordance with the present invention utilizing braided or woven multi-strand filaments.
Detailed Description
FIG. 1 sets forth a side view of a suture assembly constructed in accordance with the present invention and generally designated 10. In general terms, suture assembly 10 includes four basic elements, a generally straight body 11, a flexible elongated body 20, a plurality of tissue engaging elements 30-47, and a curved body 14. More specifically, suture assembly 10 includes an elongated straight body 11 formed of a plastic material, such as polypropylene or the like, and includes a pointed end 12 and a connector end 13. Suture assembly 10 further includes a flexible elongate filament 20 having an end 22 secured to connector 13 in the manner described below. Flexible body 20 further supports a plurality of tissue-engaging elements 30 through 47, which are described in more detail below with respect to FIGS. 4 and 5. It is sufficient to note that tissue-engaging elements 30 through 47 are substantially identical in construction and are received upon flexible body 20. In addition, tissue-engaging elements 30-47 include generally conical structures that impart directional (orienting) characteristics or properties to the suture assembly in its engagement with tissue. As best seen in FIG. 3, flexible body 20 further defines a plurality of tied knots 50-67 tied within flexible body 20 to provide a limit to the movement of tissue-engaging elements 30-47 relative to flexible body 20. Flexible body 20 further defines an end 21 that is received within connector 16 of curved body 14. The curved body 14 further defines a sharp tip 15. Connectors 13 and 16 secure ends 22 and 21 of flexible body 20 using a conventional crimp connection. The suture of the present invention may be made of absorbable or non-absorbable materials to be suitable for patients and surgery.
As described above, the suture assembly of the present invention is suitable for use in a variety of wound closure, tissue approximation, tissue support, suspension and/or fixation procedures. However, as also noted above, the present suture assembly is particularly well suited for use in procedures involving facial lifting or contouring during orthopedic procedures. During such application, the directional grip or directional feature provided by tissue-engaging elements 30 through 47 further enhances the lifting and contouring capability of the suture. In preferred fabrication, the entire suture is made of a monofilament material, such as polypropylene or the like. Alternatively, absorbable materials, such as PDF, may also be used. Once inserted beneath the skin, the directional features of tissue-engaging elements 30-47 form a permanent support structure for the tissue and actually lift and contour the tissue. While not limited to use in any particular procedure, the suture of the present invention is well suited for lifting and contouring nasolabial (smile) lines, as well as for retracting the patient's chin or other parts of the body that require lifting or contouring. The procedure (surgery) utilizing the present invention is extremely safe and requires less time than conventional plastic surgery. Procedures utilizing the suture of the present invention may be performed under local anesthesia where the patient remains comfortably awake. In this process, the suture is inserted deep into the subcutaneous tissue along the (course) line where the new contour is desired. Typically, as few as 3 suture insertions will significantly raise the cheek contours, while as few as 2 properly placed sutures can be used to pull the patient's chin back and forth. The suture may also be used to raise the forehead of the patient and pull back the neck tissue. Moreover, the present invention suture may be used elsewhere, such as with lumbar tie. Once inserted, the tissue gripping and lifting effect is maximized after several months when collagen is formed in the patient's tissue around the tissue engaging element.
It will be apparent to those skilled in the art that the number of tissue-engaging elements employed in the present suture assembly will depend somewhat on the choice and can be readily varied to suit a particular application or use. Thus, the number of tissue-engaging elements shown in FIG. 1 should be considered illustrative of the principles of operation of the present suture assembly and not limiting of the structure of the present invention.
FIG. 2 sets forth a side view of the suture portion of suture assembly 10. As noted above, the present invention suture includes an elongated flexible, preferably monofilament body 20 formed of a material such as polypropylene or the like. Flexible body 20 defines an end 21 and an end 22. A plurality of tissue-engaging elements 30 through 47 are strung upon flexible body 20. As best seen in FIG. 3, flexible body 10 is tied to define a plurality of knots (knots 50-67 shown in FIG. 1). Knots 50 through 67 are disposed on flexible body 20 at generally uniform intervals and serve to limit movement of tissue-engaging elements 30 through 47 upon flexible body 20. Thus, it will be apparent that tissue-engaging elements 30 through 67 are continuously disposed upon flexible body 20 and that a corresponding plurality of knots 50 through 67 are tied in front of each tissue-engaging element as it is threaded upon end 22 of flexible body 20. For example, assembly of tissue-engaging elements 30 through 47 upon flexible body 20 begins with tissue-engaging element 47 being passed through end 22 to a desired position upon body 20. Knot 67 is then tied to flexible body 20. Tissue engaging element 67 is then threaded onto end 22 of flexible body 20 and positioned adjacent tissue engaging element 47. Flexible body 22 is then knotted to form knot 66. This process continues as each tissue-engaging element is threaded onto end 22 of flexible body 20 and then moved into proximity with the previous tissue-engaging element behind which the correspondingly positioned knot is tied to flexible body 20. Once all of the desired tissue-engaging elements have been assembled onto flexible body 20 and the corresponding movement-limiting knots have been tied in flexible body 20, flexible body 20 is readily assembled into straight body portion 11 and curved body portion 14 (see FIG. 1) to complete the suture.
FIG. 3 sets forth an enlarged view of a portion of flexible body 20 showing a cross-section of tissue-engaging elements 44 and 45 secured in the manner described above. Thus, in the example of FIG. 3, flexible body 20 is shown supporting tissue-engaging elements 44 and 45. Accordingly, flexible body 20 has been tied to form a pair of knots 65 and 64, each of which restricts the position of a respective tissue-engaging element 44 and 45. In this manner, tissue-engaging elements 44 and 45 are capable of transmitting a tractive force from flexible body 20 to the surrounding tissue engaged by elements 44 and 45. Again, it is noted that this engagement is directional in that elements 44 and 45 provide significantly greater engagement force to the tissue in the direction indicated by arrow 48.
FIG. 4 sets forth a cross-sectional view of tissue-engaging element 30. It will be apparent to those skilled in the art that tissue-engaging elements 30 through 47 (see FIG. 1) are substantially identical in construction. Thus, FIG. 4 and the description given in connection therewith should be understood to apply equally to tissue-engaging elements 31 through 47. More specifically, tissue-engaging element 30 is generally frustoconical in shape and thus defines a narrow end 75 and a flared end (wide end) 77. End 75 defines an aperture 76, aperture 76 being sized to fit snugly upon flexible body 20 (see FIG. 2). The flared end 77 provides increased volume for the interior portion thereof. The conical shape of tissue-engaging element 30 and the open nature of flared end 77 and interior 78 cooperate together to provide substantial tissue-engaging characteristics to element 30. As noted above, the tissue-engaging elements of the present invention may be manufactured using injection molding or cold forging techniques, as desired. While a number of suitable materials may be used to fabricate the tissue-engaging elements of the present suture assembly, a material such as polypropylene has been found to be suitable and advantageous. Alternatively, absorbable materials may be used.
Fig. 5 sets forth a rear view of tissue-engaging element 30 showing flared end 77 and interior 78. Also visible in FIG. 5 is the extension of aperture 76 through end 75 of the tissue-engaging element.
Figure 6 sets forth a partial cross-sectional side view of straight body 11 without being attached to flexible body 20. As mentioned above, the straight body 11 is made of a suitable material, such as polypropylene or the like, and defines a tapered end 12 and a connector end 13 that form a somewhat pointed structure. Connector end 13 is shown in partial cross-section and defines an interior bore 17. Bore 17 is sized to receive an end of flexible body 20 (see FIG. 1). Once the end of flexible body 20 has been received within bore 17, connector 13 secures straight body 11 to flexible body 20 by utilizing a conventional crimping process.
Fig. 7 shows a partial cross-sectional view of the curved body 14. As described above, curved body 14 defines a sharp tip 15 and a connector end 16. The connector end 16 defines an internal bore 18, the internal bore 18 being sized to receive an end of a flexible body 20 (see fig. 1) in a snug-fit manner (snug-fit). The flexure 14 is preferably formed of a plastic material such as polypropylene or the like. Connector end 16 is connected to flexible body 20 to form the structure shown above in figure 1 by pulling forward through insertion end 21 (see figure 1) of flexible body 20 into bore 18, after which a conventional crimping operation is applied to connector end 16. The very sharp point formed in the end 15 facilitates insertion of the bend 14 into the skin or other tissue.
Fig. 8 and 9 present cross-sectional and rear views, respectively, of an exemplary alternative embodiment tissue-engaging element. The difference between the tissue-engaging elements shown in fig. 8 and 9 and those shown in fig. 4 and 5 is a generally elliptical cross-section, rather than the circular cross-section of the embodiments described above.
More specifically, FIG. 8 sets forth a cross-sectional view of an elliptical tissue-engaging element, generally designated 70. Tissue-engaging element 70 defines a narrow end 71 having an aperture 72 formed therein. The member 70 further defines an open end 73 and an interior 74. The element 70 is preferably manufactured using an injection molding or cold forging manufacturing process. It will be apparent to those skilled in the art that tissue-engaging element 70 can provide a straightforward alternative to tissue-engaging elements 30 through 47 shown in FIG. 1. It will further be apparent to those skilled in the art that a plurality of tissue-engaging elements, such as element 70, may be used in the same manner as elements 30-47 described above. The elliptical cross-section of tissue-engaging element 70 has been found to provide certain advantages in certain applications; in general, however, the operation of tissue-engaging element 70 is substantially the same as the operation of tissue-engaging element 30 shown in FIG. 4.
FIG. 9 sets forth a rear view of tissue-engaging element 70 showing aperture 72 and interior 74 formed therein. Tissue-engaging element 70 further defines an open end 73.
Fig. 10 sets forth a side view of yet another alternate embodiment of the present invention suture, generally designated 80. By comparing the embodiment of the present invention shown in fig. 2 with the embodiment shown in fig. 10, it will be apparent to those skilled in the art that suture thread 80 provides a bi-directional suture. Suture 80 includes an elongated flexible body 81 having ends 82 and 83. A first plurality of tissue-engaging elements 90 through 99 are supported on body 81 and are positioned by a plurality of knots 110 through 119. The knots 110 to 119 are simple knots tied on the filament 81 in the above-described manner. Suture 80 further includes a second plurality of oppositely facing tissue-engaging elements 100 through 109. Tissue-engaging elements 100 through 109 are disposed on filament body 81 in an opposite orientation to elements 90 through 99. In a manner similar to the suture described above, a plurality of knots 120-129 are tied in filament 81 to fix the position of tissue-engaging elements 100-109. It will be apparent to those skilled in the art that the orientation of tissue-engaging elements 90 through 99 opposite tissue-engaging elements 100 through 109 provides suture 80 with a bi-directional grasping feature suitable for insertion during procedures requiring bi-directional grasping. It will also be apparent to those skilled in the art from a review of fig. 2 and 10 that alternative arrangements to the arrangement of tissue-engaging elements shown in fig. 2 and 10 may be employed without departing from the spirit and scope of the present invention. In accordance with an important advantage of the present suture, the fixation of the tissue-engaging elements to the filaments and the orientation of the tissue-engaging elements can be varied or combined as desired to meet specific and specific requirements in a given procedure.
FIG. 11 sets forth a perspective view of a tissue-engaging element constructed in accordance with a further alternative embodiment of the present invention. Referring back to the frustoconical embodiment of the tissue-engaging element of the present invention given above in fig. 4 and 5, fig. 8 and 9 show elliptical cross-sectional cones forming alternative configurations of the tissue-engaging element. FIG. 11 illustrates a faceted embodiment of the present invention wherein the outer shape of the tapered tissue-engaging element defines a plurality of facets. Thus, in FIG. 11, tissue-engaging element 85 defines a hole 87 therethrough. Tissue-engaging element 85 is generally tapered to define a narrow end and a wide end, and its outer surface is covered by a plurality of facets 86. Tissue-engaging element 85 is adapted for replacement into any of the suture assemblies described above and is representative of further alternative shapes for the tissue-engaging elements of the present invention sutures. Thus, it will be apparent to those skilled in the art that a variety of tissue-engaging element configurations or shapes can be considered and utilized without departing from the spirit and scope of the present invention.
Referring also to fig. 12A and 12B, which are front and cross-sectional views, respectively, tissue-gripping element 140 defines a frustoconical body 141 having a front aperture 145 formed therein. The taper 141 further defines a plurality of elongated slots 142, 143, and 144. Slots 142, 143, and 144 further assist in tissue bonding or tissue engagement of tissue-engaging element 140.
Referring concurrently to fig. 13A and 13B, which provide respective front and cross-sectional views, tissue-engaging element 150 defines a tapered body (cone) 151 having an aperture 157 formed therein. Taper 151 further defines a plurality of end projections 152, 153, 154, 155, and 156. Projections 152-156 cooperate to enhance the tissue bonding and tissue engaging capabilities of tissue engaging element 150.
Referring also to fig. 14A and 14B, which set forth respective front and cross-sectional views, tissue-engaging member 160 includes a tapered body 161 defining an opening 162 therein. Tapered body 161 defines a generally square end that provides a square cross-section to enhance the tissue-gripping and tissue-engaging capabilities of tissue-engaging element 160.
Referring also to fig. 15A and 15B, which provide respective front and cross-sectional views, tissue-engaging element 170 defines a tapered body 171 having an aperture 172 formed therein. The tapered body 171 further defines a plurality of lobes 173, 174, 175 and 176 at its larger end. Lobes 173-176 enhance the tissue engaging and tissue gripping capabilities of tissue-engaging element 170.
Referring also to fig. 16A and 16B, which set forth respective front and cross-sectional views, tissue-engaging element 180 includes a tapered body 181 defining an aperture 182 therein. The enlarged end of body 181 defines three lobes 183, 184, and 185. Lobes 183-185 enhance the tissue engaging and tissue gripping capabilities of tissue engaging element 180.
Referring also to fig. 17A and 17B, which show front and cross-sectional views, respectively, tissue-engaging element 190 defines a disk-shaped body 191 having a central aperture 192 formed therein.
With reference to the different shapes of tissue-engaging elements set forth above, it will be apparent to those skilled in the art that a variety of tissue-engaging element shapes may be employed without departing from the spirit and scope of the present invention. As will also be apparent from the following discussion and the accompanying drawings, a corresponding variety of positioning elements may be used to mate with the various tissue-engaging elements described herein. The primary function of the tissue-engaging elements is to provide a grasping and engaging feature for the suture, while the function of the positioning elements, such as the knots discussed above, is to limit the movement of the tissue-engaging elements and thereby transfer the grasping force of the suture to the tissue-engaging elements.
FIG. 18 sets forth a suture portion including a tissue-gripping element formed by knotting an elongated flexible body of suture. It will be apparent to those skilled in the art that FIG. 18 illustrates a portion of a suture constructed in accordance with the present invention. Referring to fig. 1, it can be recalled that the completed suture structure comprises a flexible elongated body and an elongated straight or curved needle portion. It will thus be appreciated that the embodiment shown in fig. 18 forms part of a suture of the present invention employing the remainder of the structure described above. More specifically, fig. 18 shows a portion of suture 195 having an elongated flexible body 196, with elongated flexible body 196 supporting a plurality of tissue-engaging elements 197, 198, and 199, with tissue-engaging elements 197, 198, and 199 being formed by tying knots in elongated flexible body 196. It will be apparent to those skilled in the art that the purpose of tying knots such as knots 197,198 and 199 in elongated flexible body 196 is to provide enlarged sections which serve as tissue-engaging elements. Thus, a variety of different knots may be tied in flexible body 196 to provide this function without departing from the spirit and scope of the present invention.
FIG. 19 sets forth a side view of a completed suture structure constructed in accordance with an alternative embodiment of the present invention and generally referenced by numeral 200. In general, suture assembly 200 is generally constructed in accordance with the manufacture of suture 10 set forth in FIG. 1, in that it provides a pair of needle-like structures that are generally rigid and connected by an elongated flexible body. It should be noted that a further similarity is that suture assembly 200 includes a plurality of tissue engaging elements that are disposed upon an elongated flexible body by a positioning element, such as a knot or enlarged bead. Suture assembly 200 differs from the suture assemblies set forth above in that it further includes an elongated portion of the flexible body that is free of tissue engaging elements and which supports an elongated tissue bonding sleeve positioned on the flexible body. As described below, the function of the tissue-bonding sleeve is to provide structure that further enhances the gripping and tissue-engaging features of suture 200. In essence, the porous structure of the tissue bonding sleeve allows tissue to grow into the pores and strongly bond the sleeve and ultimately suture to the patient's tissue. The present sutures can be made from a variety of implantable materials, including absorbable or non-absorbable materials.
More specifically, suture 200 includes a pair of elongated, generally resilient needles 201 and 204 having pointed ends 202 and 205, respectively. Needles 201 and 204 further define respective connection ends 203 and 206. An elongated flexible body 210 is secured between the connecting ends 203 and 206 of needles 201 and 204. Note that in the example of suture 200 shown in fig. 19, needles 201 and 204 both define straight needles. However, it will be apparent to those skilled in the art that either of needles 201 and 204 may define a curved or hooked section as shown in FIG. 1 above.
Manufactured as described above, elongated flexible body 210 supports a plurality of spaced tissue-engaging elements 201 through 220, with such tissue-engaging elements 201 through 220 being positioned upon flexible body 210 by a corresponding plurality of knots 221 through 230. Moreover, elongated flexible body 210 supports a second plurality of tissue-engaging elements 231-240, and these tissue-engaging elements 231-240 are positioned upon flexible body 210 by a corresponding plurality of knots 241-250 or other positioning elements 241-250. As will be apparent to those skilled in the art in light of the following description, the positioning elements 221-230 and 241-250 may alternatively be knots in the elongated flexible body 210 or may comprise sections of a belt head or belt bead as described below and shown in FIG. 20.
In accordance with this alternative embodiment of the present invention, elongated flexible body 210 defines a portion which is free of tissue-engaging elements 211 through 220 and 231 through 240. An elongated flexible tissue bonding sleeve 251 is supported upon the portion of elongated flexible body 210. For illustrative purposes, sleeve 251 is shown supported upon elongate flexible body 210 substantially equidistant from both sets of tissue-engaging elements. It will be apparent, however, that the position of sleeve 251 may vary according to the requirements of a particular suture 200. The sleeve 251 is positioned by positioning elements 254 and 255 at each end 252 and 253 of the sleeve 251.
In the preferred fabrication, sleeve 251 is elongated and somewhat flexible and defines a central passage that allows it to be supported upon elongated flexible body 210. In further preferred fabrication in accordance with the present invention, the sleeve 251 is preferably formed of a material, such as Google (Gortex) or other suitable implantable material. The preferred function of the sleeve 251 is achieved as the generally porous structure of the sleeve 251 allows tissue within the patient's body to "grow into" or bond with the sleeve 251. This process provides enhanced tissue gripping capability as the patient's tissue extends into and bonds with the body of sleeve 251.
As noted above, the present invention suture may be manufactured with a variety of different shaped tissue engaging elements. Furthermore, as also noted above, the attachment or positioning of these tissue-engaging elements may similarly vary over the elongated flexible body portion of the suture. Thus, FIGS. 20-24, presented below, provide side views of the suture portions of these alternative embodiments, which may be made in accordance with various embodiments of the present invention. Thus, in FIGS. 20-24, it will be appreciated that these figures illustrate a portion of a suture assembly which is manufactured in its entirety in the manner of FIGS. 1 and 19 and in accordance with the configuration of sutures 10 and 200 illustrated herein.
More specifically, and with reference to FIG. 20, suture portion 260 is shown having an elongated flexible body 261 with a plurality of positioning elements 262, 263 and 264 formed thereon. Positioning elements 262, 263 and 264 may alternatively comprise knots tied in flexible body 261 or may be molded or forged onto the flexible body in the manner shown in FIG. 3. In a simple embodiment, the tissue-engaging elements may be formed by simply "flattening" the flexible body to form enlarged portions in one dimension. Flexible body 261 supports a corresponding plurality of tissue engaging elements 265, 266, and 267. As should be noted in FIG. 20, tissue-engaging elements 265, 266 and 267 are unevenly spaced. Thus, it will be apparent to those skilled in the art that while uniform tissue-engaging element spacing is contemplated and utilized in many instances, in other applications, the spacing of the tissue-engaging elements may vary and may be non-uniform as desired.
FIG. 21 shows suture portion 270 having an elongated flexible body 271 upon which tissue-engaging element 272 is supported. As should be appreciated from the point of view of FIG. 21, a connection 273 between tissue-engaging element 272 and flexible body 271 is employed which provides a direct connection and eliminates the need for a positioning element. For example, the connection may include ultrasonic welding, laser welding, adhesive connection, or other direct connection mechanisms.
Fig. 22 provides a partial cross-sectional view of the suture portion 275. The importance of suture portion 275 is that it utilizes a flexible body and tissue engaging elements of unitary construction. Accordingly, flexible body 276 is molded or forged to provide a plurality of tissue-engaging elements 277, 278, and 279. Such molding or forging processes are known in the art and may be used in certain embodiments of the present invention.
FIG. 23 sets forth a partial cross-sectional view of suture 280 having an elongated flexible body 281 with a plurality of positioning elements 282, 283 and 284 formed thereon as an integral part of flexible body 281. The integral formation may be provided by a forging or moulding process or a staking or stamping process. With respect to positioning elements 282, 283 and 284 as shown, a corresponding plurality of tissue engaging elements 285, 286 and 287 are positioned upon flexible body 281.
FIG. 24 sets forth a side view of a suture portion, generally referenced 290, employing a multi-strand braided or woven elongated flexible body 291. Body 291 may be made from a variety of implantable materials, such as braided polyester, nylon, or other materials. A plurality of positioning elements 292 and 293 are formed on body 291 as knots tied therein. A corresponding plurality of tissue engaging elements 294 and 295 are also shown on body 291. For the embodiment of the invention shown in FIG. 24, it is important that the braided or woven nature of body 291 further enhance the tissue bonding characteristics of the overall suture construct. The braided or woven features of body 291 allow tissue to grow to adhere to and grow into the interstices between the various strands of body 291. In this manner, tissue adherence is greatly enhanced because the entire flexible body of the suture assembly provides direct tissue bonding, which is better than that achieved with a monofilament flexible body used in a suture. The braided or woven nature of body 291 provides for better attachment or tissue bonding initially. But perhaps more importantly, eventually grows into the interstices within the braided or woven strands, which provides tissue engagement along the entire length of the flexible body portion of the suture.
What is shown herein is a novel suture assembly that provides an implantable, directional camming device that can be made directional or bidirectional. The illustrated suture assembly may be manufactured using injection molding or cold forging manufacturing techniques and is suitable for wound closure, tissue compression, tissue support, suspension, and/or fixation. The illustrated tissue-engaging elements have a circular cross-section or an elliptical cross-section. The present invention suture assembly may be inserted into the body with or without an introducer. The present suture is designed to work in conjunction with the post-operative healing process. The present suture assembly is shown holding the wound closed without suture tying to maintain tissue approximation.
While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects. Therefore, it is the object of the appended claims to cover all such variations and modifications as come within the true spirit and scope of the invention.