AU724906B2 - Knotless suture anchor assembly - Google Patents

Description

It 1 1

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT 4**t 9* a* Name of Applicant: Actual Inventor: Address for Service: Invention Title: THAL, Raymond THAL, Raymond CULLEN CO., Patent Trade Mark Attorneys, 240 Queen Street, Brisbane, Qld. 4000, Australia.

KNOTLESS SUTURE ANCHOR ASSEMBLY a The following statement is a full description of this invention, including the best method of performing it known to me: KNOTLESS SUTURE ANCHOR ASSEMBLY BACKGROUND OF THE INVENTION i. Field of the Invention The present invention relates to devices or assemblies used in tissue repair. More particularly, the assembly enables the attachment together or repair of portions of biological tissue tendons or ligaments) onto a bone surface.

2. Description of the Background Art Soft tissues, such as tendons and ligaments, generally are attached to bone by small collagenous fibers. These connections are strong but permit the tendons and ligaments to be flexible. When a tissue is torn away from the bone and requires repair, a surgeon is often required to repair the detached soft tissue with sutures which are passed through bone tunnels and tied. A number of devices have been developed for securing a ligament or tendon to a bone mass. These devices can be used in place of bone tunnelling techniques. These attachment S devices are usually inserted through extensive surgical incisions *eo and, in some circumstances, by arthroscopic surgical techniques.

The use of bone tunnels for repair can be difficult and generally require large open incisions. Recently, through the advent of endoscopic surgery, where the surgeon looks into a joint cavity with a telescope, there has been a trend to repair soft tissues back to bone through small incisions called portals. The unique knotless suture anchor assemblies described herein facilitate this difficult and precise procedure.

A variety of devices are available for attaching objects to bone, such as screws, staples, cement, suture anchors, and sutures alone. These devices have been used to attach soft tissue, such as ligaments, tendons, muscles, as well as bbjects such as protheses, to bone. A suture anchor is a device which utilizes small anchors with suture materials attached thereto.

A device, such as a screw, is inserted into the bone mass and anchored in place. After insertion of the anchor, the attached suture is passed through the tissue to be repaired. The tying of a knot in the suture is then required to secure the tissue to the bone. The process of passing the anchored suture through the ft ii 3 soft tissue and tying a knot is time consuming and difficult to undertake in the tight space encountered during endoscopic surgery and sometimes even in conventional open surgery.

One example of a suture anchor assembly is disclosed in U.S. Patent No. 5,370,662, wherein an anchor assembly includes a pre-threaded suture positioned at its posterior. First the anchor is inserted into the bone mass. The attached suture is then passed through the tissue for reattachment. The surgeon is required to tie a-knot with the suture to complete the surgical process. Some suture anchors can be passed through the soft tissue first and then into the bone. Most suture anchors need coo• to be inserted into the bone first. Only after this has been accomplished can the sutures be passed through the soft tissue.

Alternatives to this procedure include non-suture soft tissue anchor systems. A few of these systems, such as those disclosed in U.S. Patent Nos. 5,013,316 and 4,532,926, can be used arthroscopically but fixation with these devices may not be as secure as that achieved with sutures. Only a few points of fixation are possible with the non-suture type anchor since the oeooe device is relatively large. Therefore suture devices are more favorable. This type of non-suture staple device is disadvantageous in that it has been known to crack the bone during S deployment, or accidentally transect the object being attached to the bone. In addition, the device itself has been known to crack or break during or after deployment.

U.S. Patent Nos. 5,037,422; 5,224,946; and 5,236,445 all disclose bone anchor configurations for attaching sutures within openings formed in bones during joint reconstructive surgery and endoscopic surgical procedures. With all these intricate procedures, the suture itself must be inserted through a tissue mass and tied with a surgical knot to repair the soft tissue to bone.

A primary object of the present invention is to provide a suture anchor assembly which is easy to use and install.

Another object of the present invention is to provide a suture anchor assembly which allows for secure attachment of 4 soft tissue to bone without the use or requirement of tying a knot.

SUMMARY OF THE INVENTION In one broad form, the invention provides a knotless suture anchor assembly for securing tissue to bone, comprising: a first anchor member for attachment to the bone; a first suture element connected to the first 10 anchor member and having catch means thereon; a second anchor member for attachment to the :bone; a second suture element connected to the second anchor member and having a stop member thereon engageable with the catch means; ,whereby in use, the first and second anchor members are attached to the bone, and at least one of the first and second suture elements is inserted through the tissue, the stop member being engagable with the catch 20 means to secure the tissue to the bone.

Typically, the catch means has an aperture, and the stop member has at least one dimension greater than the aperture, whereby in use the stop member engages the catch means by being caught by the aperture of the catch means.

The first and second anchor members may be attached directly to the bone, and for this purpose, the first and second anchor members may suitably be harpoon anchors, wedge-like anchors, umbrella-like anchors, ribbed anchors, threaded anchors or pronged anchors.

The invention also provides a method for attachment of tissue to bone utilizing the abovedescribed assembly, the method comprising the steps of: a) inserting at least the catch means through said tissue; b) attaching the first anchor member to the bone; c) attaching the second anchor member into the bone; engaging the stop member with the catch means to thereby secure tissue to the bone.

In an alternative embodiment, the anchor members are attached indirectly to the bone. In this alternative embodiment, the knotless suture anchor assembly further comprises first and second anchor base members adapted to be fixed to the bone in use, each anchor being engagable with a respective anchor base 1. 0 member. Each anchor base member is typically a hollow anchoring sleeve adapted to receive an anchor member therein.

This invention also provides a method for attachment of tissue to a bone using the assembly of the alternative embodiment described above, the method comprising the steps of: a) installing the two hollow anchoring sleeves in the bone; b) inserting the first anchor member into the 20 first hollow anchoring sleeve; c) inserting the catch means through the tissue; d) engaging the stop member with the catch means; and e) inserting the second anchor member into the second hollow anchoring sleeve to thereby secure the tissue to the bone.

The first and second anchor members may be installed into the respective hollow anchoring sleeves prior to the installation of the hollow anchoring sleeves into the bone. Alternatively, the second anchor member can be inserted through the tissue after the stop member engages the catch means, prior to insertion into the second hollow anchoring sleeve.

Each anchor member may be inserted into its respective sleeve by ratcheting down the anchor member into the sleeve to a desired depth.

The anchoring sleeve can have a closed pointed drill end or be totally cylindrical in shape. The hollow anchoring sleeve can be ribbed or threaded on its exterior for secure attachment to the bone or embody varying types of anchor configurations to facilitate a strong bond with the bone mass. A number of prior patents disclose configurations for the exterior of a bone anchor which are within the contemplation of the invention for use as the anchoring means for the exterior of the hollow anchoring sleeve.

1. 0 Incorporated by reference are U.S. Patent Nos.

*49* 4,007,743; 4,632,101; 4,721,103; 4,870,957; 4,898,156; .4,946,468; 5,084,050; 5,102,421; 5,141,520; 5,192,303 and 5,207,679, which all illustrate varying exterior structures which may be used on the anchoring sleeve portion of the invention. These patents disclose various means and mechanisms for anchoring a device to a bone 6**S mass thus preventing pull-out of the sleeve after *.44 insertion into bone.

Further, the hollow anchoring sleeve can have a 20 collar on the rear or outer end thereof to control the eeoc depth of sleeve insertion into the bone and prevent excessive insertion depth.

The knotless suture anchor assembly of this invention enables soft tissue to be secured to bone without the need to tie a knot. Endoscopic procedures and some open surgical procedures are extremely difficult and must be completed in a very tight space. Obviation of the need of tying a knot is extremely beneficial and innovative.

Various embodiments of knotless suture anchor assemblies will now be described with reference to the accompanying drawings. Not all of the illustrated embodiments are claimed in the claims of this application. Some of the illustrated embodiments are claimed in the parent patent application from which this application was divided, or in other patent applications divided from the parent application. However, the various knotless suture anchor assemblies are described in this application for completeness and comparative purposes.

BRIEF DESCRIPTION OF THE DRAWINGS Figs. la, ib, ic and id are perspective views of a hollow anchoring sleeve; Fig. 2 is a perspective view of a spike member with suture element; Fig. 3 is a perspective view of an alternative spike member with suture element; Fig. 4 illustrates usage of a hollow anchoring sleeve and a spike member in conjunction with a bone mass ee and tissue during surgical reattachment; Fig. 5 illustrates the spike member in place in ***the hollow anchoring sleeve after attachment of tissue to bone mass has been completed; Fig. 6 illustrates an alternative knotless suture anchor assembly; Fig. 7 illustrates the procedure for attachment of tissue to bone mass using the knotless suture anchor 20 assembly of Fig. 6; Fig. 8 illustrates the knotless suture anchor assembly of Fig. 6 showing tissue attached to bone; Fig. 9 illustrates the spike components for a knotless suture anchor assembly according to one embodiment of this invention; Fig. 10 is a partial exploded view of the spike components of Fig. 9 and hollow anchoring sleeves inserted through soft tissue and mated together for attachment of tissue to bone mass; Fig. 11 is an illustration of the knotless suture assembly of Figs. 9 and 10 wherein tissue is attached to a bone mass in a secure manner; Fig. 12 illustrates an alternative spike member with suture element; Fig. 13 illustrates the spike member of Fig. 12 in conjunction with a bone mass and tissue during surgical reattachment; Fig. 14 illustrates a knotless suture assembly 8 according to another embodiment of this invention; Fig. 15 illustrates the knotless suture assembly of Fig. 14 in conjunction with a bone mass and tissue during surgical reattachment; Fig. 16 is an enlarged perspective view of a harpoon anchor; Fig. 17 is an enlarged perspective view of an umbrella-like anchor; Fig. 18 is an enlarged perspective view of a ribbed anchor; Fig. 19 is an enlarged perspective view of wedge-like anchor; :t Fig. 20 is an enlarged perspective view of a threaded anchor; Fig. 21 is an enlarged perspective view of a pronged anchor; n Figs. 22a and 22b are perspective views of spike members with suture element and stop means; Figs. 23a and 23b are perspective views of 20 spike members with suture element and alternative stop S" means; Figs. 24a and 24b are perspective views of spike members with alternative suture element and stop o means; Figs. 25a and 25b are perspective views of spike members with suture element and alternative stop means; Figs. 26a and 26b are perspective views of spike members with suture element and alternative stop means; Fig. 27 illustrates the procedure for attachment of tissue to bone mass for the knotless suture assembly of Fig. 22b; Fig. 28 illustrates the procedure for attachment of tissue to bone mass for the knotless suture assembly of Fig. 22a; and Fig. 29 illustrates one procedure for attachment of tissue to bone mass for the knotless suture assembly of Fig. 23b.

DETAILED DESCRIPTION OF EMBODIMENTS Referring now to Fig. i, a knotless suture anchor assembly has a hollow anchoring sleeve for installation and attachment to a bone mass. The hollow anchoring sleeve 1, as shown in Fig. la, is cylindrical in shape and possesses ribs or threads on its exterior.

The device can also contain or be configured with prongs, umbrella spokes, have threads, be expandable, or have wedges, on its exterior, for secure attachment with the bone mass. These exterior attachment features are known to the industry and incorporated herein by reference.

!:Fig. lb illustrates an alternate embodiment of the hollow anchoring sleeve 2 having a collar 3 to control depth of bone penetration. The collar prevents the sleeve from being forced too deep into the bone mass when the spike or plug member is inserted.

Fig. Ic illustrates an alternate embodiment of the hollow anchoring sleeve 4 wherein the sleeve has a 20 pointed closed end 5 for ease of penetration into a bone mass.

Fig. ld illustrates a hollow anchoring sleeve 7 with a collar 6 and a closed pointed end 8 as an alternate construction.

The hollow anchoring sleeve may also be shaped or configured with any suitable means to secure said structure to a bone mass. The hollow anchoring sleeve may include a threaded exterior as disclosed in U.S.

Patent No. 5,370,662, incorporated herein by reference.

Further, the device may be expandable as disclosed in U.S. Patent No. 5,084,050 incorporated herein by reference. A configuration such as disclosed in U.S.

Patent Nos. 5,037,422; 5,224,946; and 5,236,445 are also contemplated by the invention and these disclosures are incorporated by reference. Harpoon configurations such as disclosed in U.S. Patent Nos. 5,141,520 and 5,102,421 are also contemplated for the hollow anchoring sleeve and incorporated herein by reference.

The anchoring sleeve in a harpoon-type fashion such as disclosed by U.S. Patent Nos. 4,632,101 and 4,721,103 for secure anchoring within the bone mass.

U.S. Patent Nos. 4,898,156; 5,207,679; 4,946,468; and 5,192,303 disclose anchoring mechanisms which can be utilized for the hollow sleeve member for installation within a bone mass. These patents are incorporated by reference and fall within the contemplation of the present invention for methods or means for anchoring to the bone mass. It is also within the contemplation of the present invention to configure this dowel-like hollow sleeve in any suitable fashion to securely attach same to a bone mass.

The interior surface of the hollow anchoring sleeve is ribbed, beaded, threaded, expandable or smooth for secure engagement with said exterior surface of said spike member.

In addition to a sleeve as illustrated in Fig.

1, the knotless suture anchor assembly includes an anchor 20 member and suture element. Fig. 2 shows a perspective view of an anchor member in the form of a spike plug member, with attached suture element. Spike or plug member 12 is preferably cylindrical in shape with a sharp first end 14 and a second end 16 wherein the suture element 18 is attached.

The suture element 18 has at its distal end a loop or ring 22. The loop or ring portion 22 can be constructed of the same suture material as suture element 18 or it can be a separate molded material attached to the suture element 18 and loop portion 22 may be one molded component and attached to spike member 12 at end 16 or they may be all (spike, suture element and loop portion) one entire molded component. Further, the suture element 18, alone, can be made from any type suture material which has been approved for surgical procedures for attachment of tissue to bone.

The spike or plug member can form any shape so long as it mates with the hollow cylindrical sleeve as described above. The exterior of the spike or plug member 12 may be ribbed or threaded 24 as depicted in Fig. 2 or may be beaded or expandable to allow for a secure tight fit with the inner hollow cylinder of the anchoring sleeve. Once inserted into a hollow anchoring sleeve, the exterior surface of the spike or plug member 12 engages the inner surface of the sleeve and can be ratcheted down to produce the desired tight fit. This ratcheting effect allows for fine tuning and tightening of the soft tissue to the bone during repair.

The length of the suture connection 18 is 5.5. variable and may be adjusted prior to selection of a tool or during surgical procedure through any appropriate means. Likewise, the diameter of the loop 22 is 15 adjustable and may be replaced by one long strip of suture-like material, or molded strip, 26 having a slot hole 28 for insertion of the spike or plug member once it has been passed through a tissue for attachment.

Fig. 3 illustrates an alternative version of 20 the spike member, with suturing material. The spike member 32 has attached at its rear end one complete loop eeoc of suture 34 which also has an adjustable diameter for various thicknesses of tissue reattachment.

Referring now to Fig. 4, there is illustrated a process for reattachment of tissue to bone mass. Bone mass 42 has a slot or hole 44 wherein a hollow anchoring sleeve 46 has been inserted. A tissue 48 has inserted therein a spike member 52 threaded through loop 54 for reattachment to the bone mass 42.

Fig. 5 depicts the knotless suture anchor assembly in place after the surgical procedure has been completed. Bone mass 62 has tissue 64 attached or reattached thereto.

The surgical procedure for reattaching or attaching tissue to bone mass includes first installation of the hollow anchoring sleeve 66. Secondly, the spike member 68 is inserted through the tissue 64 and then through at least one loop portion 72 to form a securing loop encompassing at least some of the tissue. The spike 68 with tissue 64 securely attached thereto is then secured directly into the anchoring sleeve 66 for attachment of tissue 64 to bone mass 62.

Referring now to Fig. 6, there is illustrated an alternate knotless suture anchor system 82. There is disclosed a hollow anchoring sleeve 84 having attached thereto a spike or plug member 86 by a suture element 88.

The hollow anchoring sleeve 84 may take the shape or form of almost any type of anchor device. All the patents listed above are incorporated by reference.

Configurations of the hollow anchoring sleeve having a collar, as well as a configuration incorporating any type of umbrella expansion means or threading on the exterior or interior of the sleeve are contemplated. Further, the spike or plug member 86 is preferably threaded on its exterior with a pointed end for insertion through a o tissue element. This may take the form of any structure and preferably has an exterior which is ribbed, beaded, 20 threaded, smooth or expandable. Likewise, the suture element 88 may be made of any acceptable surgical suture material and in addition is lengthened based upon thickness and need requirements.

Referring now to Fig. 7, there is depicted the initial step in a process for attachment of tissue to bone utilizing the alternate knotless suture assembly of Fig. 6. A spike member 96 is inserted through a tissue 94 and into a hollow anchoring sleeve 98. The assembly is then attached to a bone mass 92.

Referring now to Fig. 8, there is disclosed the completed attachment or reattachment of tissue 102 to bone mass 104. The spike or plug member 106 is inserted through said tissue 102 and then inserted into hollow anchoring sleeve 108 for complete attachment to bone mass 104 at a previously drilled section 110. This enables one to surgically reattach the tissue 102 to bone mass 104 in a virtual one step process.

Additionally, the process embodiment by Fig. 8 may be undertaken in two steps. First, the spike member 106 is inserted through the soft tissue 102 and into the hollow anchoring sleeve 108.

Secondly, the entire assembly 112, spike member 106 which has been inserted into the sleeve 108, is inserted into the bone mass 104. Regardless of the process used, the repair tightness is adjusted by the depth of anchor insertion into bone and/or the ratcheting effect of the spike in the anchor sleeve.

Fig. 9 depicts a knotless suture anchor assembly according to one embodiment of this invention.

First and second spike or plug assembly members, 120 and 130, respectively, are depicted for the knotless suture anchor assembly. There is disclosed first spike or plug 15 assembly member 120 having spike means 121 for insertion into a hollow anchoring sleeve as depicted in Figs. la Id. Spike or plug member 121 is preferably threaded with a pointed end for insertion through a tissue element and secure fixation with said hollow anchoring sleeve. The 20 spike or plug member may take the form of any suitable structure and preferably has an exterior which is ribbed, threaded, beaded, expandable or smooth. The diameter of thickness of the member is preferably equal to or incrementally less than the entire diameter of the hollow anchoring sleeve for a secure fit. In situations where ribs, threads, beads, or the like, are utilized on the spike member, the diameter of the member with protrusions may initially exceed the inner diameters of the hollow anchoring sleeve and would deform upon insertion.

The rear end 122 of the spike member 121 has attached or tied thereto a suture element 123. The suture element 123 has attached or molded therewith a catch device, such as a ring element, 124 which is preferably rigid. The spike member 121, suture element 123 and catch device (ring element) 124 may be made of separate materials or molded together as one piece. In addition, the spike member 121 and suture element 123 may be molded as one element or the suture element 123 and catch device (ring element) 124 may be molded as one element.

Second spike assembly member 130 includes a spike or plug member 131 for insertion into a hollow anchoring sleeve as depicted in figs. la id. The element 131 is described above and can be the same or different as spike element 121. To the rear end 132 of the spike member 131 there is tied or attached a suture element 133. The suture element 133 has attached or molded therewith a spherical, or the like, stop means 134.

o As stated above, the three components, spike member 131, suture element 133 and stop means 134 can be combined as separate components or molded together as one S 15 entire component or a combination of two components.

Referring now to Fig. 10, first spike assembly member 120 is inserted into tissue 140. The spike member 121 can be inserted into a hollow anchoring sleeve 142 either before or after the hollow anchoring sleeve 142 is 20 inserted into bone mass 150. Spike member 131, of spike member assembly 130, is inserted through catch device (ring element) 124, of spike member assembly 120. The spike member 131 is then inserted through tissue 140 and then into hollow anchoring sleeve 144, or directly into hollow anchoring sleeve 144. The hollow anchoring sleeve 144 can be anchored to bone mass 150 before or after spike member 131 has been inserted therein. The stop means 134 mates with catch device (ring element) 124 dragging the tissue into a secure fit with bone mass 150 (see Fig. 11).

Once the spike members have been inserted into the hollow anchoring sleeves they can be ratcheted down to a desired depth to adjust the tightness of the soft tissue repair to bone mass. Tightness can also be adjusted by the depth of anchor sleeve insertion into the bone mass.

Stop means 134 may be spherical with a diameter greater than catch device (ring element) 124, or may be any shape which would facilitate a mating with the catch device. Likewise, the catch device need not becircular, but requires only an opening to allow passage of a spike member and prevent passage of the stop means. The catch device 124, depicted in Figs. 10 and 11, can take the form of a ring, square, slot, or any shape that will cooperate and hold stop means 134 from being pulled therethrough.

Knotless suture anchor assembly 150 shown in Fig. 12 includes a spike/anchor means 152, a suture element 154, and a loop portion 156. As discussed above, *r e *the suture element 154 and loop portion 156 may be made of the same or different materials. In addition, the ***spike/anchor means 152 can be molded with the suture element 154 and loop portion 156 as one piece or as separate components, as desired. The spike/anchor means can be configured, as desired, to securely attach the o assembly 150 to a bone mass. The spike/anchor means may include all the attachment means as described above for 20 the hollow anchoring sleeve such as harpoon type means 158, prongs, umbrella spokes, threads, wedges or the like.

Additionally, the entire suture element 154 may be configured in a complete loop as depicted in Fig. 3, or may merely have a slit along its length as depicted in Fig. 2.

When performing a procedure, loop portion 156 is pulled through soft tissue 160. Once the loop portion 156 has been pulled through the soft tissue 160, the spike/anchor means 152 is inserted through the loop portion 156 and directly into bone mass 170 for attachment of tissue 160 to bone mass 170. The length of suture 154 and depth of insertion of the spike/anchor means 152 controls the secure tightness of repair of tissue 160 to bone mass 170, and is adjusted as desired.

Fig. 14 depicts an alternative knotless suture system according to a second embodiment of the invention.

A first knotless suture anchor assembly 180 is provided as described in accordance with knotless suture anchor assembly 150, as depicted in Fig. 12. The loop 181 functions as a catch device. A second knotless suture anchor assembly 185 is also provided to be used in conjunction with assembly 180 to perform a surgical attachment of tissue to bone. The anchor assembly 185 has a stop means 187.

First the catch device 181 is inserted through soft tissue 190 from the underside of the tissue first (see Fig. 15). Then a spike/anchor means 182 of assembly 180 is inserted into the bone mass 192. Next, a •go• spike/anchor means 186 (with bone anchoring features) is oooo threaded through catch device 181 and inserted into bone mass 192. Stop means 187 mates or engages with catch 15 device 181 and the sutures 183 and 188 are pulled taut to securely attach soft tissue 190 to bone mass 192.

Fig. 22, including 22a and 22b, shows oeoo perspective views of spike plug members with suture element and stop means, of the two-piece and one-piece 20 versions, respectively. Spike or plug member 212 is preferably cylindrical in shape with a sharp first end 214 and a second end 216 wherein the suture element 218 is attached. The suture element 218 has at its distal end a disc-like stop means 222. The stop means 222 can be constructed of any suitable material. The stop means 222 and suture 218 may be one molded component attached to spike member 212 at end 216. Further, the suture element 218, alone, can be made from any type suture material which has been approved for surgical procedures or a molded material for attachment of tissue to bone.

The spike or plug member can form any shape so long as it mates with the hollow cylindrical sleeve as described above. The exterior of the spike or plug member 212 may be ribbed or threaded 224 as depicted in Fig. 22 or may be beaded or expandable to allow for a secure tight fit with the inner hollow cylinder of the anchoring sleeve. Once inserted into a hollow anchoring sleeve, the exterior surface of the spike or plug member 212 engages the inner surface of the sleeve and can be ratcheted down to produce the desired tight fit. The interface of the spike and sleeve allows for movement of the spike in only one direction and resists pullout or movement out of the sleeve. This ratcheting effect allows for fine tuning and tightening of the soft tissue to the bone during repair. The length of the suture connection 218 is variable and may be adjusted prior to selection of a tool or during surgical procedure through any appropriate means. Likewise, the diameter of the disc-like stop means 222 is adjustable.

Fig. 22b is identical to 22a but for anchoring means 226 attached to the spike or plug member 228. This one-piece version allows for tissue reattachment without an anchoring sleeve. The spike or plug member anchors directly into the bone mass.

Fig 23 illustrates alternative versions of the eeee spike member with suturing material and stop means. In Fig. 23a, the spike member 232 has attached at its rear a 20 suture 234 and a rod-like stop means 236. This functions as a one-piece anchor. Fig. 23b illustrates the spike or plug member of the two-piece version when used in combination with an anchoring sleeve.

Fig. 24 illustrates alternative versions of the spike member with suturing material and stop means. In Fig. 24a, the two-piece embodiment, spike member 240 has attached thereto at least one suture means 242 connected to a stop means 244 configured in the shape of a ring or hoop. Fig. 24b illustrates the one-piece embodiment wherein anchoring means 246 is attached to the spike or plug member 248 for attachment to bone without an anchoring sleeve.

Fig. 25 contains alternate versions 25a and Fig. 25a, the two-piece embodiment, includes a spike means 250, a suture means 252 attached thereto, and an Xlike stop means 254. Fig. 25b, the one-piece embodiment, illustrates an embodiment of the configuration wherein anchoring means 256 is attached to the spike or plug means 258 for attachment to bone when an anchoring sleeve is not utilized.

Fig. 26 contains Figs. 26a and 26b which are alternative embodiments. Fig. 26a illustrates a spike member 260, suturing means 262 attached thereto, and a stop means 264 configured in a horseshoe configuration.

Fig. 26b illustrates an alternative version of the horseshoe configuration wherein the spike or plug member 266 has anchoring means 268 attached thereon for direct attachment to bone without the utilization of an anchoring sleeve.

Referring now to Fig. 27 and Fig. 28, there is illustrated a surgical procedure for reattaching or attaching tissue to bone depicting the spike or plug embodiments illustrated in Fig. 22. The procedure can be used with any of the embodiments outlined in figs. 22, 23, 24, 25 and 26. Fig. 27 illustrates the procedure wherein an anchoring sleeve is not utilized. Spike or plug means 270 having anchoring means 272 is inserted 20 through tissue 274 and directly into bone 276. The stop

C

means 278 grabs the tissue 274 and pulls same back into reattachment or attachment with bone 276 when the spike or plug member is forced into the opening in the bone.

ee. The tightness of the repair is adjusted by the length of suture 270 and/or the depth of the insertion of spike member 272 into the bone mass.

Fig. 28 depicts a procedure wherein an anchoring sleeve 280 is first inserted into bone mass 282. Subsequent to the insertion of the anchoring sleeve 280, a spike or plug member 286 is inserted through tissue 284 and into the anchoring sleeve 280. The spike or plug member 286 is then ratcheted down into the anchoring sleeve 280 to pull tissue mass 284 into direct and secure mating with bone mass 282.

Referring now to Fig. 29, there is an alternative surgical procedure disclosed for utilization of the rod-like stop means depicted in Fig. 23.

Initially the rod-like stop means 290 is inserted through tissue mass 292. Once the rod-like stop means rests on top of the tissue mass, the spike or plug member 294 is then inserted into a previously inserted anchoring sleeve 296. The spike or plug member 294 is then ratcheted down into the anchoring sleeve for secure mating or attachment of the tissue 292 to the bone mass 300. This procedure may also be undertaken with the one-piece anchor having a spike or plug means as depicted in Fig. 23a which omits the initial insertion of an anchoring sleeve.

In addition to the shapes illustrated for the stop or catch means portion, the stop means can be any planar or non-planar shape such as, but not limited to, 6e C-shaped, planar with one or more openings bar-shaped, curved or non-planar bar-shaped. Further the stop means is attached to the spike or plug member by one or more suture elements. The suture element or connection can be 'Osseo made up of a known suture material such as Ethibond® or fees 6*0_Prolene®, or it can be made of polymer materials such as ultrahigh molecular weight polyethylene. The connection 20 or suture element can be formed of bio-absorbable Cmaterials such as a polylactide polymer. Additionally, Goo* the suture element can be part of the stop means and formed by a molding process or the like.

The suture element can be connected to the stop means and an anchor in a variety of ways such as fusion or molding or by mechanical means such as glue, a weld or by mere tying.

In many situations throughout the discussion above, the terminology "secure attachment of soft tissue to bone" has been used. Such terminology refers to the attachment or reattachment of tissue to bone through the insertion of a spike member into a hollow anchoring sleeve or a spike/anchor means into a bone mass. In the former situation, the spike member can seat into the sleeve in a one step mating procedure or be inserted and ratcheted down in a step wise fashion into the sleeve.

Either situation will function effectively and selection is based upon the instant facts of the surgical procedure. Further, the sleeve itself may be seated in the bone mass at varying depths. Again, such depth is a selection based upon the facts of the instant procedure.

In the latter situation, where a spike/anchor means is used, depth of insertion of the device into the bone is a selection or choice of the surgeon during the procedure.

In all situations, the spike member or spike/anchor means is designed not to back up or exit once mated with the sleeve, ratcheted down into the sleeve, or inserted into the bone mass to avoid and prevent withdrawal therefrom.

It is also within the contemplation of the invention to make the spike or plug member for a direct insertion into the bone with screws, prongs, spikes, a 9* wedge means or any means wherein the spike or plug member anchors securely into the bone mass facilitating attachment or reattachment of tissue to skin.

~Further, the spike or plug member or a portion of the spike or plug member may be made with 20 bioabsorbable material.

o*9.a.

While various embodiments of the invention in a knotless suture anchor system have been shown and described herein, it should be understood that the o oo present disclosure is made by way of example only and 25 that variations to the structures shown and their use are possible within the scope of this disclosure without departing from the scope of the following claims.

Throughout this specification and claims, unless the country intention appears, the term "comprising" is used in the inclusive sense, i.e. to include the stated integers or steps without necessarily excluding other integers or steps.

Claims (13)

1. A knotless suture anchor assembly for securing tissue to bone, comprising: a first anchor member for attachment to the bone; a first suture element connected to the first anchor member and having catch means thereon; a second anchor member for attachment to the bone; a second suture element connected to the second anchor member and having a stop member thereon engageable with the catch means; whereby in use, the first and second anchor members are attached to the bone, and at least one of the first and second suture elements is inserted through the tissue, the stop member being engagable with the catch means to secure the tissue to the bone.

2. A knotless suture anchor assembly as claimed in claim 1, wherein the catch means has an aperture, and the 20 stop member has at least one dimension greater than the aperture, whereby in use the stop member engages the .9 catch means by being caught by the aperture of the catch means.

3. A knotless suture anchor assembly as claimed in 25 claim 1 or 2, wherein the first and second anchor members are adapted to be attached directly to the bone, the first and second anchor members being harpoon anchors, wedge-like anchors, umbrella-like anchors, ribbed anchors, threaded anchors, or pronged anchors.

4. A method for attachment of tissue to bone utilising the assembly as claimed in any preceding claim, comprising the steps of: a) inserting at least the catch means through said tissue; b) attaching the first anchor member to the bone; c) attaching the second anchor member into the bone; engaging the stop member with the catch means to thereby secure tissue to the bone.

A knotless suture anchor assembly as claimed in any one of claims 1 to 3, wherein the anchor members are attached indirectly to the bone, the knotless suture anchor assembly further comprising first and second anchor base members adapted to be fixed to the bone in use, each said anchor member being engageable with a said anchor base member.

6. A knotless suture assembly as claimed in claim wherein each anchor base member is a hollowanchoring sleeve adapted to receive a said anchor member therein.

7. A knotless suture assembly as claimed in claim 6, wherein each said sleeve has an exterior surface which is ribbed, threaded, pronged, or smooth for secure engagement of the sleeve with the bone.

8. A knotless suture anchor assembly as claimed in claim 6 or 7, wherein each said sleeve has an interior surface which is ribbed, threaded, or smooth for secure 20 engagement of the anchor member. oo:

9. A knotless suture anchor assembly as claimed in any one of claims 6 to 8, wherein each said sleeve has a collar at one end thereof to facilitate flush engagement eo e S"of the sleeve with the bone 25

10. A knotless suture anchor assembly as claimed in any one of claims 6 to 9, wherein each said anchor member has an exterior surface which is smooth, ribbed, threaded, beaded or expandable, for secure engagement of the anchor member with the sleeve.

11. A method for the attachment of tissue to a bone utilising the assembly as claimed in any one of claims 6 to 10, comprising the steps of: a) installing the two hollow anchoring sleeves in the bone; b) inserting the first anchor member into the first hollow anchoring sleeve; c) inserting the catch means through the tissue; d) engaging the stop member with the catch means; and e) inserting the second anchor member into the second hollow anchoring sleeve to thereby secure the tissue to the bone.

12. A method for attachment of tissue to a bone in accordance with claim 11, wherein the first and second anchor members are installed into the respective hollow anchoring sleeves prior to installation of the hollow anchoring sleeves into the bone.

13. A method for the attachment of tissue to a bone in accordance with claim 11 wherein the second anchor oo member is inserted through the tissue after the stop member engages the catch means and prior to insertion into the second hollow anchoring sleeve. S14. A method as claimed in any one of claims 11 to 13 wherein each anchor member is inserted into its respective sleeve by ratcheting down the anchor member into the sleeve to a desired depth. 20 15. A knotless suture assembly as hereinbefore oolee: described with reference to Figs. 9-11 or 14-15. S"DATED this 21st day of January 2000 RAYMOND THAL By his Patent Attorneys Cullen Co.