Tissue Fastener

W0 03/043503 A2 ||||||||||||||ll||||||||||||||||ll||||||||||||||||||||||||||||||||||||||||||||||||||| (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 30 May 2003 (30.05.2003) (51) International Patent Classificationlz A61B 17/00 (21) International Application Number: PCT/EP02/13012 (22) International Filing Date: 20 November 2002 (20.11.2002) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 09/988,748 20 November 2001 (20.11.2001) US (71) Applicant: BIONX IMPLANTS OY [Fl/FT]; Hermi- ankatu 6-8 L, FlN—33720 Tampere (PI). (72) Inventors: TORMALA, Pertti; Saarenkarjenkatu 5 as 2, FIN—33300 Tampere (FT). VALIMAA, Tero; Pyynikintie 39 B 20, FIN—33230 Tampere (PI). (54) Title: TISSUE FASTENER 3a 2a PCT (10) International Publication Number WO 03/043503 A2 (74) Agents: SIEGFRIED, J. et al.; Beetz & Partner, Steins- dorfstrasse 10, 80538 Miinchen (DE). (81) Designated State (national): JP. (84) Designated States (regional): European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, SK, TR). Published: without international search report and to be republished upon receipt of that report For two-letter codes and other abbreviations, refer to the "Guid- ance Notes on Codes and Abbreviations " appearing at the begin- ning of each regular issue of the PCT Gazette. (57) Abstract: The present invention provides a surgical fastener (1) made of a bioabsorbable elastomeric material for the repair of tissues. The fastener may be elongated, thereby creating a compression force across or within the tissue being repaired. The present invention also includes embodiments drawn to methods of using the surgical fastener, such as applying the surgical fastener to a ruptured meniscus or using the surgical fastener to attach a fibrous implant or tissue transplant on or in a living tissue, and an apparatus for installing the fastener. W0 03/043503 _ PCT/EP02/13012 [0001] The present invention relates to surgical and more specifically to bioabsorbable elastomeric surgical fasteners used to tissues, methods for using these fasteners, and an apparatus for these fasteners. ' _BACKGROUND ART . [0002] With reference to the prior art in the field, it has been shown that fixation of meniscus uamnas, like ruptures and lesions, by suturing withfabsorbable sutures gives better results than the removal of tratirnafized meniscal tissue (see, e. g., NA Paitnen‘,'r_1=. Winters, . A.E.. Joiner and 1'. Evans, frhe Development and Testing of the Arthroscopic Meniscal t Staple”, Arthroscopy, Vol. 5, No. 2, 1989, p. 136 (Ref. 1)). However, arthroscopic suturing is a-complicated tedious technique where risks for the patient are significant because of the danger presented to vessels and nerves. Additionally, the .sut1n'ing'o_f meniscus ruptures leaves a single or several loops ‘of sutureson me meniscal surface, which can imitate joint cavity tissues. Therefore, surgeons have long deshed an absorbable meniscus lesion fixation 0 device, like a staple or fastener, which has the advantages of absorbable sutu;ring‘techniques 0 but which can be used more rapidly and safelv than sutures. . [0003] Several research groups have tried to develop absorbable meniscus lesion fixation devices such as clamps and tacks. However, the variousdemands upon-such a. device are high. It must be strong enough to good contact of lesion tissues after thevoperafion so that rapid healing ocexns. The device must retain its strength long enough to allow for . good healing.‘ rherigioity or the device must be eoinpethxe with the tissue being repaired; if the rigidity of the device is too high it may cause tissue irritation-and healing maybe prolonged or even stopped The device must be comprised of a material that is absorbed without causing complications that would prevent the healing of the lesion. Additionally, the 0 _ installation of the should be easy and should cause operational _ ‘ h-anm,a. Because of these high demands, efiorts to develop an opfimal absorbable meniscus lesion fixation device continue. Pahneri et all reported‘ in Ref. 1 the development of a. method ‘ of meniscal repair using arthroseopically applied absorbable fasteners. However, the _ reported method was complicated becausethe final design used cannulation of the staple for needle-guided placement.‘ Additionally, staple EL-acture, migration and articular abrasion were found.’ W0 03/043503 . _ . . PCT/EP02/13012 [0004] In meniscal repair surgery, bioabsorbable _devices are known in the art. For example, .Schreiber (U .S. Pat. No 4,873,976) discloses an arrow-like implant particularly intended for the surgical repair of meniscal ruptures. However, the arrow—likeimplant according to this publication has the disadvantage that particularly its proximal end (stem) contacts the outer surface of the meniscus and may cause tissue irritation and abrasion, particularly if left protruding from the outer surface of the meniscus. Similarly,'Bays et al.. (U.S. Pat. Nos. 4,884,572 and 4,895,141) and Winters (US. Pat. No. 5,059,2O6)Vdescribe a meniscalsurgical-repair devices made of .biodegradable material. A disadvantage of the device described in Bays is that the grip portion is bulky and may remain on meniscal surface ‘ causing irritafion inside a joint cavity. In Winters, the fastener device has a proximal end that is bulky, comprising a cylindrical end, which protrudespartially above and/or below the outer 0 surface of the meniscus, which may cause irritation and abrasion of the tissue. ’ [0005] Recent developments in bioabsorbable devices for use in surgical meniscal repair include a fastener and installation device disclosed by Justin et al. (US. Pat. No. 5,569,252) and Tamminmaki et al. (US. Pat. No. 5,562,704). In Justin," the fastener requires a rotating motion for installation that is slow and tedious to use arthroscopically. Additionally, rotating the fastener through fibrous tissue, such as meniscus tissue, has the risk, that the fibrous tissue ' may twist arotmd the turning implant, hindering or preventing the installation of the implant. Tamrninmalci et al. (U .S. Pat. No. 5,562,704) discloses an arrow-like bioabsorbable implant wherein the proximal part of the implant (the wings) preferably remains on the surface of the meniscus. Therefore, there is a risk of irritation or abrasion of the opposite (foral) cartilage surface if the surgical installation of the arrow is not performed precisely. Furthermore, if the proximal part the wings is located inside of meniscal tissue, the surface capsule of the meniscus should first be ‘cut horizontally with a special cutting ‘blade. This lengthens the operation time and may damage the meniscus surface. A [0006] Lin et al. (U .S. Pat. No. 5,993,475) describes a fastener for repairing meniscal . . cartilage tears having a shaft and two ends, one end is adapted to pierce the tissue and the opposite end is adapted to fit a driver. The device has been subjected to _a drawing operation afier fabrication leaving themolecules in the shaft in a state of higher static residual stress. When the device is exposed to an aqueous environment, the water absorbed by the polymer lowers the glass transition temperature of the polymer. Lowering glass transition temperature allows increased molecular mobility causing the device to contract. The contraction pulls the torn tissues into close apposition during healing. The residual stress and aqueous environment are the key components in the action of this device. This implant, which needs 2 W0 03/043503 _ , PCT/EP02/13012 aqueous environment, is depended on the amount of the tissue fluid in fixed tissue. The amount of tissue fluid varies in different tissues and therefore the action of this implant and the speed of connaction are limited by these tissue properties. Furthermore, the speed of the relaxation pro_cess that cause the contractionjis slow and therefore the fixation result may not be seen during the surgery. The contraction force that is caused by relaxation is small and therefore the compression force between tissue lesions is low and the fixation may'not_ be secure. The relaxation of the material in storage or-in higher temperatures than normal room temperature, e. g. during transportation, may cause premature relaxation of static residual stresses and as a consequence the implant does not contract. Therefore, this implant is very 0 sensitive to storage andtransportation conditions. 0 . , [0007] Orthopedic and Musculoskeletal Markets Biotechnology and Tissue Engineering, Medical Data International, Inc., Irvine, Califomia, USA, Feb. 1997, p._ 1-17. describes a I bioabsorbable device for meniscal repair. This device has two legs with rnoldedbarbs that ' are attached by a flexible member composed of a resorbable suture. The device is installed into a meniscus with an arthroscopic tool_ so that the legs penetrate the rupture of meniscus to . holdthe edges together. However, the two-leg device requires a bulky installation tool, which ' makes arthroscopial installation of the device difiicult. [0008] Patent application PCT/EP 908/04183 describes a fastener for body tissue repair '- comprising a shafi comprised of a proximal portion, having an upper surface and a lower surface with first protrusions, and a distal portion, said distal portion having a sharpened tip and one or more first protrusions. The first protrusions of the fastener have proximal surfaces configured to arrest the movement of the shafi in the proximal direction and distal surfaces configured to permit the movent of the shaft in thedistal direction. Further, the said proximal portion have second protrusions on the upper surface and lower surface of the proximal portion, wherein said second protrusions have distal surfaces configured to arrest the movement of the shaft in the distal direction. Although this implant sinks totally inside a . tissue, such as a lmee meniscus, the second protrusions can be damaged during the insertion of the implant into tissue for the second protrusions can damage the tissue, such as cutting the H horizontal collagen fibers of the tissue, during the insertion. _ , [0009] A need therefore exists for bioabsorbahle fastener, which provides stronger and safer fixation of tissue tears. The fastener must also be rapidly and easily installedand cause minimal trauma when installed. . W0 03/043503 V V PCT/EP02/13012 SUMMARY OF THE INVENTION [0010] The present invention provides a bioabsorbable elastomeric surgical fastener for tissue repair. The surgical fastener forges a compression force between lesion tissues and secures fixation. [0011 ] It is a further object to provide such a fastener that is rapidly and easily installed, provides strong and safe fixation of the tissue tear, implant or transplant, is minimally traumatic, and may be made from an elastomeric, nontoxic, biocompati-ble bioabsorbable polymer, polymer alloy or fiber reinforced polymer composite, specially designed to maintain its structural integrity during the healing of the tear and to prevent tissue abrasion. 0 [0012] It is a firrther object to provide a fastener which ‘will be shot or pushed totally or for the most part inside of soft or tough tissue, like meniscal tissue, to penetrate the tissue (meniscal) tear and to hold the ruptured edges together and to cause a minimal trauma to the tissue through which the fastener passes. A [0013] In a preferred embodiment the elastomeric behavior of the fastener creates ‘a compression force between tissue lesion sides. This compression force helps to keep the sides together, accelerates the healing, and assures secure fixation during the healing period. The elastomeric behavior of the fastener is also insensitive to environmental conditions, e.g., amount of tissue fluids or temperature; therefore it works in tissues that have a low amount of tissue fluids. S [0014] The present invention also includes embodiments drawn to methods of using the bioabsorbable_e1astomeric surgical fastener. In such an embodiment of the present invention, the method includes applying the bioabsorbable elastomeric surgical fastener to a ruptured meniscus. Another embodiment of the present invention includes using the bioabsorbable elastomeric surgical fastener to attach a fibrous implant or tissue transplant to living tissue. The invention further relates to an apparatus for installing the fasteners of the present invention. BRIEF DESCRIPTION OFATHE DRAWINGS [0015] FIGS. IA- H illustrate side views of devices that are embodiments of the present invention. _ I [0016] FIG. 2 illustrates side views of different proximal and distal end profiles of devices that are embodiments of the present invention. [0017] FIGS. 3A- D illustrate side views of ridged and cannulated devices that are embodiments of the present invention. [0018] FIGS. 4-7 illustrate different ridge profiles in devices that are embodiments of the present invention. W0 03/043503 PCT/EP02/13012 [0019] FIGS. 8A- G illustrate sectional views of the installationof a device of the present invention into the torn meniscus. A 1 . [0020] FIGS. 9A- G illustrate sectional views of the installation of a device of the invention into atom meniscus. _ I [0021] FIGS. l0A- G illustrate sectional views of the installation of a device of the invention into a tom meniscus. [0022] FIG. 11 illustrates a sectional view of the fibrous structure of the meniscus. [0023] FIGS. l-2A- C illustrate sectional views of the fibrous structure of the meniscus in which a surgical device according to the present invention has been installed. [0024] FIG. l3A- B illustrate the fixation of a fibrous mesh to the surface of living tissue by means of devices that are embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] A description of the preferred embodiments of the present invention is presented with reference to FIGS. 1 - 12. I I [0026] A preferred exemplary embodiment of the present invention comprises a fastener and method for repairing a soft or tough tissue, like a knee meniscal tear, in a human patient. [0027] FIGS. lA- H illustrate, as viewed fi'om the side, preferred embodiments of the fastener. It is designed to have an arrow or rod shape, and it comprises a shafi 1, whose proximal portion is formed with :1 end 2 for the purpose of providing the locking element to lock the fastener l in relation to the meniscus with‘ the proximal end 2 remaining partially on the surface or totally inside of the meniscus, and whose distal portion is formed with a head 3 with a sharp or blunt tip. A purpose of the proximal end 2 is to stop the implant inside of the meniscus, the proximal end remaining partially on the surface of meniscus or totally within the meniscus during the final stage of the installation of device, and to prevent further sinking of the device into the meniscus, when the implantafion is complete and the device is compressing the tissue into which it has been inserted. Using a proper insertion device,'the fastener is forced inside of the meniscus or at least so deep into the meniscus that the end 2 is located at the bottom of a small notch on the surface of meniscus, thus causing no disturbance to the opposite joint cartilage surface of the distal joint surface of femur. [0028] FIGS. lA- H illustrate some of the various possible geometries for the ends 2 and 3. The fastener of FIG. 1A has relatively sharp tips 2a and 3a, while FIG. 1G describes a fastener with ends thatare more blunt. FIG. 1D describes a fastener with both a blunt and a sharp end. W0 03/043503 PCT/EP02/13012 [0029] Thepproximal and distal ends 2 and effectively lock the device within or partially within the meniscus, preventing its movement bothin the direction of installation and in the direction opposite to it. Afier the implant has been released in the meniscus, the elastomeric behavior of the material compresses the rupture surface as shown in FIGS. 8A-G and 9A-G. This occurs because the ends 2 and 3 lock in and push the sides of the rupture against each other during the final phase ofinstallation as shown in FIGS. 8A — G and 9A-G, [0030] Because the device, preferably, is located. mainly or totally inside of the meniscus, leaving at most only a small flexible prominence on the meniscus surface, the-risks of prior art devices, such as complications originating (a) from the presence of the rigid bulky . I proximal part of the device on the meniscal surface, or (b) from the uncertain fixation of the meniscus lesion by only the protrusions, notches or threads, are eliminated. [0031] The surfacelof the fastener can also be machined or molded to include longitudinal ridges. ‘FIG. 3A shows a side-view perspective of such a fastener having on its surface longitudinal ridges (R), which are arranged onto the surface of the fastener according to FIG. 3B, which gives the cross section of the fastener the plane.X-X of FIG. 3A. The longitudinal ridges on the surface of the fastener can bearranged in a number of possible geometries. Additionally, the geometry of the ridges can be varied to influence the gripping capacity of protrusions and of the tapered proximal end on meniscal or other tissue. FIGS. 4 - 7 illustrate some. preferred embodiments of the cross-sectional structures of ridged fasteners of the present invention. 4 _ [0032] The bioabsorbable implants of this invention can be manufactured of elastomeric bioabsorbable polymers, copolymers or polymer mixtures or alloys with crosslinking or molding methods known in the prior art, see, e.g. D.W. Grijpma et al., Polymer, 34 (1993) 1496-1503. It is also possible to use the techniques described in US. Pat. No. 4,743 ,257 to mold in a compression or injecfion mold elastomeric absorbable fibers and binding polymer together to create a fiber-reinforced. or especially a self-‘reinforced structure. The implants of this invention can be molded in a single compression molding cycle, or the protrusions can be machined on the surface of a fastener after an initial molding cycle. V i [0033] An oriented and/or self-reinforced structure can also be created during extrusion -or injection molding of absorbable polymeric melt trough a suitable die or into a suitable mold at high speedfand pressure. When cooling occurs at suitable conditions, the flow orientation of the melt remains in the solid material as an oriented or self-reinforcing smicture. In an advantageous embodiment, the mold can have the form of the implant, but it is also possible to manufacture the implants of the invention by machining (possibly using 6 W0 03/043503 PCT/EP02/13012 heat) and thermoforming (e.g. by bending the proximal end) injection-molded or extruded .semi-finished‘ products. - [0034] Oriented and/or self-reinforced or otherwise fiber-reinforced implants of this invention can be manufactured by molding the reinforcement fiber-polymer matrix to the final product in a mold, whose mold cavity has ‘the form of the final product Alternafively, the final-form can be machined mechanically (possibly also using heat) on a pre-form, such as a melt-molded and solid-state rod, as is described, e.g., in U.S. Pat. No. 4,968,3 17. [0035] In some advantageous- embodiments of this invention, the orientation and/or reinforcing elements of the elastomeric self-reinforced structure are mainly oriented in the direction of the long axis‘ of the shaft of the implant and also into the tapered, curved proximal end. The reinforcement elements may extend into any protrusionsor ridges of the implant. The reinforcement elements can also tum spirally around the long axis of the" implant and also into the wider ends. Further, other difierent orientations of reinforcement _ elements in elongated samples, which are familiar fiorn composite technology, can be applied to the present invention. A general feature of orientation land./or fiber-reinforcement or self- _ reinforcement of the implants of this invention is that many of the reinforcing elements are oriented in such a way that they can effectively carry the different extemal loads (such as . tensile, bending and shear loads) that are directed to the healing. rupture (for example loadsto I a meniscus caused by the movements of the patient’s knee). [0036] According to an advantageouslembodiment of the invention, the meniscal repair implant, or a special coating layer on its surface, may contain one or more bioactive substances, such as bioabsorbable ceramic or glass particles, antibiotics, chemotherapeutic substances, angiogenic growth factors, substances accelerating the healing of the wound, growth hormones and the like. Such bioactive meniscal repair implants are ‘especially’ advantageousin surgical use, because they chemically conuibute to the healing of the lesion in addition to providing mechanical support. I I I [0037] The fastener can also include cannulation, which can be machined or molded. I FIG. 3C shows a side‘-viewperspective of such a fastener having a longitudinal cannulation (C), as shown passing through the fastener according to FIG. 3D, which gives the cross section of the fastener in the plane Y-Y of FIG. 3C.. A I [0038] FIGS. 8A-G, 9A-9G and IOA-G illustrate various preferred methods for installing certain preferred embodiments of fasteners of the invention into ruptured meniscal tissue. Figure 8A illustrates, as viewed fiom the side, a meniscus with a rupture 6 separating the meniscus into a proximal side 7’ and a distal side 7”. As seen in FIGS. 8B-D, during the 7 W0 03/043503 PCT/EP02/13012 operation the tip 8” of an installation cannula 8 and tapered tip 3a of the fastener 10 are pushed into the knee joint through a small incision and then across the meniscal tear. The tip of the outer tube 9” is located on the surface of the proximal part of the meniscus 7’. [0039] As seen FIG. 8B, the installation cannula 8 movesto the right (proximally) and elongate-s the fastener 10 inside the cannula 8. The cannula 8 can be accelerated to a high speed so that the elongation process occurs rapidly and fixes the tear 6 at a high speed, as is illustrated in FIGS. 8D-8G. The tip of the outer tube 9” stays on the surfaceof the meniscus until the fastener has been released fiom the cannula tip 8’ ’. The cannula stops at the final stage of its movement by way of, e.g., a stopper (not shown) at the proximal end of the cannula 8. Typically, the tip of the cannula 8 stops when 0.85-ll mm inside the tip of outer tube 9”. Then theelongated fastener is released and the proximal end 2a of the fastener becomes located at the bottom of a small notch formed on the surface of the meniscus as the fastener attempts to contract When the location of the cannula tip 8” on the meniscal surface is selected in a proper way, typically 2-4 mm at the front of the meniscal tear 6, and the direction of the cannula is proper, the cannula with a fastenerpenetrates the proximal meniscus part 7’ and the tear plane 6 and the fastener closes the tearwith the compression force created by the elongation of the fastener’s elastomeric material; - As FIGS. 8F and 8G schematically show, when the elongated fastener is released, it creates a compression force across the rupture 6, as it attempts to contract thereby helping to close the rupture 6." Accordingly, the rupture 6 is closed effectively, the fastener is locked in to its position to _ keep the rupture 6 closed and at most only a small, soft part of thewhole fastener is left on A meniscal tissue. [0040] As seen in FIGS. 9A-9G, in another preferred method of insertion, the fastener 10 can be inserted so that it is located entirely within the meniscus. This insertion technique is similar to that shown in FIGS. 8A~8G, however as seen parficularly in FIGS. 9E-9G, the positioning and length of thecannula 8 can be alteredso that, when the fastener 10 is elongated and released, the proximal end 2a of the fastener 10 is located under the surface of the meniscus. As seen in FIG. 9G, because of the elastomeric nature of the fastener 10, it ’ attempts to contract after being elongated and released, and this contraction force helps to pull the meniscal rupture 6 closed,‘ [0041] FIGS.l0A-G illustrates a preferred method for installing fasteners of the invention into ruptured meniscal tissue using a eannulated fastener and guiding wire 1*-1. Figure 10A illustrates a meniscus with a rupture 6 separating the "meniscus into a proximal side 7’ and a distal side 7”. As seen in FIGS. 10B - 10D, during the operation, first the guiding wire 11 is _ 8 W0 03/043503 _ PCT/EP02/13012 pushed into the knee joint through a small incision and across the meniscal -tear followed. by the tip 8” of an installation cannula 8 and the tapered tip 3a of the fastener 10. The tip of the outer tube 9” is located on the surface of the proximal part of the meniscus 7’. The guide wire passes across the tear and helps to prevent lateral movement of the meniscus when the - fastener and the installation cannula are pushed across the rupture. Otherwise, as seen in FIGS. IOE — G, this insertion technique is similar to those shown in FIGS. 8 and 9. [0042] It is typical that the microstructure of a meniscus contains reinforcing collagen fibers. Inside the meniscus, many collagen fibers are oriented in a horizontal plane nearly . parallel to the lower surface of the meniscus. The cut ends of horizontal collagen fibers, when examined in a cut cross—section of a meniscus, can be seen rnicroscopicallyas points on the cross-sectional surface, as shown in FIGS. 11 and 12. The typical vertical meniscus lesion (rupture) 6A develops along the long axes of collagen fibers, because of the relatively weak binding forces between collagen fibers. . I [0043] Because of the arrangement of the majority of the reinforcing» horizontal collagen ' fibers inside of the meniscus, as FIGS. 11 and 12 schematically show, it is preferable that the distal end 3a and proximal end 2a of the fastener of the present invention protrude at least on ' the upper and/or lower surfaces of the fasteners. Thus, as the fastener penetrates into_the meniscal tissue, the distal end slides forward through the collagen fiber bundles and grabs 4 between the horizontal collagen fiber bundles, locking the fastener- in place. Further, it can be advantageous if the proximal portion of the fastener is wide so that the end compresses the meniscal rupture and thus locks the proximal portion to its place when the elongated fastener is released by the installation device. This is schematically shown in the meniscal cross section of FIG. 12A-C. [0044] In addition to using the fasteners of this invention to repair tears in living tissues, these fasteners can be used to attach synthetic fibrous implants, like membranes, meshes, non-woven felts, fibrous scaffolds, .etc., onto or into living tissues. Such synthetic fibrous implants are described, e.g., in EPO Pat. No. 0423155, U.S. Pat. No. 6,007,580 and PCT/EP 98/O3030. % 8 [0045] In a preferred embodiment in which the fasteners of this invention used to 0 attach a synthetic fibrous implant onto or into living tissue, the fibrous implant is first aligned on the surface or inside of living tissue. Thereafier, fasteners are pushed one afler another through the synthetic implant so that the distal part of fastener locks the fastener into the tissue below the synthetic implant and the proximal end of the implant remains on the synthetic implant, securing it on the surface‘ (or inside of the living tissue). FIG. 13A shows, 9 W0 03/043503 PCT/EP02/13012 as seen from above, and 13B, as a side view of plane B-B, a fibrous mesh 13 secured with fasteners 10 onto a living tissue 14. According to preferred embodiments, the surgical fastener of the present invention is characterized by one or more of the following features (a) to (h): (a) (b) (C) (d) (6), (f) the fastener comprises or consists of an elastomeric, nontoxic, biocompatible and bioabsorbable polymer and/or copolymer, polymer and/or copolymer mixture or polymer and/or copolymer alloy; the fastener comprises a matrix material as defined in (a) and is reinforced with elastomeric bioabsorbable reinforcement elements, preferably fibers; the fastener is as defined in (b) and is reinforced with fibers having the same chemical composition as the matrix material, thus forming an elastomeric self-reinforced structure; the fastener is as defined in (a), (b) or (c), and the matrix material and/or the reinforcement elements, preferably fibers, are mainly oriented in the shaft in the direction of the long axis of the shaft and optionally also in one or both of the end parts, preferably the proximal end; the fastener is as defined in (a), (b) or (c), and the matrix material and/or the reinforcement elements are mainly oriented in the shaft to turn spirally around the long axis of the shaft and optionally also in one or both of the end parts; the fastener is as defined in (a), (b), (c), (d) or (e), wherein the matrix material and/or the reinforcement elements comprise or consist of at least one of the following polymer materials: - a polyglycolide or a glycolide copolymer, - a polylactide or a lactide copolymer, - a glycolide/lactide copolymer, - poly-B-hydroxybutyric acid, - a polydioxanone, - a polyvinylalcohol, - a polyesteramide, - a glycolide/trimethylene carbonate copolymer, - a lactide/tetramethylglycolide copolymer, - a lactide/trimethylene carbonate copolymer, l0 W0 03/043503 PCT/EP02/13012 a lactide/5-valerolactone copolymer, a lactide/8-caprolactone copolymer, a polydepsipeptide, a polyethylene oxide copolymer, an unsymmetrically 3,6-substituted poly-1,4-dioxane-2,5-dione, a [3-hydroxybutyrate/y-hydroxyvalerate copolymer, poly-I3-hydroxypropionate, a methylmethacrylate/N-vinylpyrrolidone copolymer, an oxalic acid polyester, a polydihydropyran, a polyalkyl-2-cyanoacrylate, a polyurethane, «a polypeptide, poly-[3-malic acid, a poly-B-alkanoic acid; (g) the fastener comprises a central bore or charmel for a guiding element, preferably a guiding wire; (h) the fastener is as defined in (b), (c), (d), (e), (f) or (g), wherein the reinforcement elements are at least partially fibrillated structural units, preferably fibrils or bundles of microfibrils. The apparatus of the present invention for positioning the surgical fasteners into tissues, comprises: an installation cannula displaceably guided in an outer tube and adapted to receive and hold a fastener according to the invention, means for accelerating the cannula in retraction direction in order to elongate the fastener, and means for releasing the elongated fastener. In a preferred embodiment, a guiding wire is provided extending along the central longitudinal axis of the cannula and the outer tube, wherein the guiding wire can be introduced into the tissue site where the fastener is to be anchored. ll W0 03/043503 PCT/EP02/13012 [0046] The fasteners of this invention also can be used for attaching living tissue transplants such as autografts, allografts and xenografts, like collagen membranes and felts, periosteum transplant or connective tissue transplant. [0047] The implants of the present invention may be sterilized by any of the well-known sterilization techniques, depending on the type of material used in manufacture of the implant. Suitable sterilization techniques include heat or steam sterilization, radiation sterilization such as cobalt 60 irradiation or electron beams, ethylene oxide sterilization, plasma sterilization and the like. [0048] Having described the preferred embodiment of an improved surgical fastener and method of deploying the same in accordance with the present invention, it is believed that other modification, variations and changes will be suggested to those skilled in the art in view of the teachings set forth herein. It is therefore to be understood that all such variations, modifications and changes are believed to fall within the scope of the present invention as defined by the appended claims. 12 W0 03/043503 PCT/EP02/13012 Claims ' 1. Surgical fastener for repairing tissue, said fastener comprising: a shaft (1), said shaft (1) having a longitudinal axis and proximal and distal portions, said proximal portion comprising at least one protrusion configured to resist movement in the distal direction, said distal portion comprising at least one protrusion configured to resist mo- vement in the proximal direction, said shaft comprising an elastomeric polymer. 2. Surgical fastener according to claim 1, wherein said distal portion comprises a tape- red end. 3. Surgical fastener according to claim 1 or 2, wherein at least one of said proximal protrusions protrudes farther from said shaft than said distal protrusions. 4. Surgical fastener according to any of claims 1 to 3, wherein the shaft comprises one or more longitudinal ridges, wherein the one or more longitudinal ridges are positioned between the distal and the proximal portions of the shaft. 5. Surgical fastener according to any of claims 1 to 4, wherein the shaft comprises one or more longitudinal ridges along said distal portions, wherein said distal pro- trusions protrude from said one or more longitudinal ridges. 6. Surgical fastener according to any of claims 1 to 5, comprising one or more longi- tudinal carmulation holes. 7. Surgical fastener according to any of claims 1 to 6, wherein the fastener comprises a bioactive material. 8. Surgical fastener according to claim 7, wherein the bioactive material is selected from bioabsorbable ceramic or glass particles, antibiotics, chemotherapeutic sub- 13 099-58.781PCT/ SF/cf W0 03/043503 PCT/EP02/13012 stances, angiogenic growth factors, wound healing accelerators, growth hormones, and the like. Surgical fastener according to any of claims 1 to 7, characterized by one or more of the following features (a) to (h): (a) (b) (d) (6) (D the fastener comprises or consists of an elastomeric, nontoxic, biocompati- ble and bioabsorbable polymer and/or copolymer, polymer and/or copoly- mer mixture or polymer and/or copolymer alloy; the fastener comprises a matrix material as defined in (a) and is reinforced with elastomeric bioabsorbable reinforcement elements, preferably fibers; the fastener is as defined in (b) and is reinforced with fibers having the same chemical composition as the matrix material, thus forming an elastomeric self-reinforced structure; the fastener is as defined in (a), (b) or (c), and the matrix material and/or the reinforcement elements, preferably fibers, are mainly oriented in the shaft in the direction of the long axis of the shaft and optionally also in one or both of the end parts, preferably the proximal end; the fastener is as defined in (a), (b) or (c), and the matrix material and/or the reinforcement elements are mainly oriented in the shaft to turn spirally around the long axis of the shaft and optionally also in one or both of the end parts; the fastener is as defined in (a), (b), (c), (d) or (e), wherein the matrix mate- rial and/or the reinforcement elements comprise or consist of at least one of the following polymer materials: - a polyglycolide or a glycolide copolymer, - a polylactide or a lactide copolymer, - a glycolide/lactide copolymer, - poly-[3-hydroxybutyric acid, - a polydioxanone, - a polyvinylalcohol, - a polyesteramide, 14 W0 03/043503 10. PCT/EP02/13012 - a glycolide/trimethylene carbonate copolymer, - a lactide/tetramethylglycolide copolymer, - a lactide/trimethylene carbonate copolymer, - a lactide/6-valerolactone copolymer, - a lactide/8-caprolactone copolymer, - a polydepsipeptide, - a polyethylene oxide copolymer, - an unsymmetrically 3,6-substituted poly-1,4—dioxane-2,5-dione, - a B-hydroxybutyrate/y-hydroxyvalerate copolymer, — poly-[3-hydroxypropionate, - a methylrnethacrylate/N-vinylpyrrolidone copolymer, - an oxalic acid polyester, - a polydihydropyran, - a polyalkyl-2-cyanoacrylate, - a polyurethane, - a polypeptide, - poly-B-malic acid, - a poly-[3-alkanoic acid; (g) the fastener comprises a central bore or channel for a guiding element, pre- ferably a guiding wire; (h) the fastener is as defined in (b), (c), (d), (e), (f) or (g), wherein the reinfor- cement elements are at least partially fibrillated structural units, preferably fibrils or bundles of microfibrils. Method of repairing a ruptured meniscus, comprising the steps of: aligning a fastener of any of claims 1 to 9 on the surface of the meniscus; positioning the fastener into the meniscus so that the fastener bridges the rupture; elongating the fastener to create a compression force within the fastener; and releasing the elongated fastener such that the compression force tends to close the rupture. 15 W0 03/043503 1 1. 12. 13. 14. 15. 16. 17. PCT/EP02/13012 The method of claim 10, wherein, following insertion, at least a part of the proximal portion of the fastener is at the surface of the meniscus. The method of claim 10, wherein, following insertion, the fastener in its entirety is located within the meniscus. The method of any of claims 10 to 12, wherein the fastener is elongated prior to being positioned across the rupture. Method of attaching an implant or tissue tranpslant to tissue, comprising the steps of: aligning the implant or transplant on the surface of the tissue; positioning a fastener of any of claims 1 to 9 so that it passes through the im- plant or transplant and into the tissue such that at least a part of the distal portion of the fastener is located in the tissue and at least a part of the proximal portion of the implant is positioned on the surface of the implant or transplant; elongating the fastener to create a compression force within the fastener; and releasing the fastener such that the compression force tends to keep the implant or tissue transplant on the tissue. Method according to claim 14, wherein the implant or transplant is selected from the group comprising a synthetic, polymeric mesh or scaffold, collagenous mesh or scaf- fold, periosteum transplant and connective tissue transplant. Use of the fasteners according to claims 1 to 9 for repairing ruptured tissues, particu- larly a ruptured meniscus, and for attaching implants and transplants to tissues. Apparatus for positioning the surgical fasteners according to claims 1 to 9 on or in tissues, comprising: an installation cannula (8) displaceably guided in an outer tube (9") and adap- ted to receive and hold a fastener according to any of claims 1 to 9, means for accelerating the carmula (8) in retraction direction in order to elonga- 16 W0 03/043503 PCT/EP02/13012 te the fastener, and means for releasing the elongated fastener. 18. Apparatus according to claim 17, characterized in that a guiding wire (11) is provi- ded extending along the central longitudinal axis of the cannula (8) and the outer tube (9"), wherein the guiding wire (11) can be introduced into the tissue site where the fastener is to be anchored. 17 W0 03/043503 PCT/EP02/13012 1/17 Figure 1 W0 03/043503 PCT/EP02/13012 Figure 3 313 " % Cross section X 3D Cross section Y W0 03/043503 PCT/EP02/13012 6 / l 7 Figure 8 A 7 W0 03/043503 _ PCT/EP02/13012 W0 03/043503 PCT/EP02/13012 8 / l 7 Figure 8 G 10 8:9 9” 2a 7” . 7 , W0 03/043503 PCT/EP02/13012 9/17 A Eigure 9 W0 03/043503 W0 03/043503 PCT/EP02/13012 l l / 1 7 G Figure 9 W0 03/043503 PCT/EP02/13012 12/17 Figure 10 777 79 W0 03/043503 PCT/EP02/13012 W0 03/043503 PCT/EP02/13012 14/17 7” 3a 10 W0 03/043503 PCT/EP02/13012 15/17 Figure 11 W0 03/043503 PCT/EP02/13012 16/l7 Figure 12 PCT/EP02/13012 10 17/17 Figure 13 13 13 10 B . .V..t.I...V. \\ &,.\e.,§ A , .&x».\&wWwW«,. .»»»»~«~....» M«~«~«~«~««..\.««..«..«,.«,&..«.. 13A B 1 3B Cross section B-B W0 03/043503 A3 ||||||||||||||ll||||||||||||||||ll||||||||||||||||||||||||||||||||||||||||||||||||||| (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 30 May 2003 (30.05.2003) (51) International Patent Classification7: A61B 17/064 (21) International Application Number: PCT/EP02/13012 (22) International Filing Date: 20 November 2002 (20.11.2002) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 09/988,748 20 November 2001 (20.11.2001) US (71) Applicant: BIONX IMPLANTS OY [Fl/FT]; Hermi- ankatu 6-8 L, FlN—33720 Tampere (FT). (72) Inventors: TORMALA, Pertti; Saarenkarjenkatu 5 as 2, FIN—33300 Tampere (FT). VALIMAA, Tero; Pyynikintie 39 B 20, FIN—33230 Tampere (PI). (54) Title: TISSUE FASTENER PCT (10) International Publication Number WO 03/043503 A3 (74) Agents: SIEGFRIED, J. et al.; Beetz & Partner, Steins- dorfstrasse 10, 80538 Miinchen (DE). (81) Designated State (national): JP. (84) Designated States (regional): European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, SK, TR). Published: with international search report (88) Date of publication of the international search report: 30 October 2003 For two-letter codes and other abbreviations, refer to the "Guid- ance Notes on Codes and Abbreviations " appearing at the begin- ning of each regular issue of the PCT Gazette. (57) Abstract: The present invention provides a surgical fastener (1) made of a bioabsorbable elastomeric material for the repair of tissues. The fastener may be elongated, thereby creating a compression force across or within the tissue being repaired. The present invention also includes embodiments drawn to methods of using the surgical fastener, such as applying the surgical fastener to a ruptured meniscus or using the surgical fastener to attach a fibrous implant or tissue transplant on or in a living tissue, and an apparatus for installing the fastener. |NTEFlflATIONAL SEARCH REPORT lnternatio pplication No PCT/E‘ 02/13012 A. CLASSIFICATION OF s BJECT MATTER IPC 7 A61B17 064 Accordingto International Patent Classification (IPC) orto both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) IPC 7 A618 Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practical, search terms used) EPO-Internal, NPI Data C. DOCUMENTS CONSIDERED TO BE RELEVANT Category ° Citation of document. with indication, where appropriate, of the relevant passages Relevant to claim N0. N0 00 49950 A (ETHICON INC) 17,18 31 August 2000 (2000-08-31) page 5, line 6 —page 6, line 12 page 14, line 12 -page 21, line 20 figures 24-26,30,31 1-8 EP 0 608 139 A (ETHICON INC) 27 July 1994 (1994-07-27) page 3, line 27 - line 29 N0 99 49792 A (BIONX_IMPLANTS DY) 7 October 1999 (1999-10-07) the whole document US 5 993 475 A (LIN STEVE T ET AL) 30 November 1999 (1999-11-30) cited in the application figures Furtherdocuments are listed in the continuation of box C. Patent family members are listed in annex. ° 5 I I I ' f ‘t d d t : . . pee a Ca egones 0 C‘ e ocumen S 'T' later document published after the lr_lternatlonal.filin_g date 'A' document defining the general state of the art which is not (c’ir‘§g?g'1l¥n(:,:tr:1aa':g,?fi;]3rfgfg:gtg:':E'gg; considered to be of particular relevance invennon E efaflleréiotcument but published on or afler the international .X. documem of pamcmar relevance; the claimed invention I lng a e cannot be considered novel or cannot be considered to 'L' document which may throw doubts on priority claim(s) or Involve an inventive step when the document is taken alone ‘"{{"?.h '5 ‘meg t° e5tai°"5h ‘he P"b"°a"°“t‘.’a‘e °f anmher 'Y' document of particular relevance; the claimed invention C‘ 3 '0" °' ° er Spec“ reason (35 spewed) cannot be considered to involve an inventive step when the '0' document referring to an oral disclosure, use, exhibition or document is combined with one or more other such docu- other means _ments, such combination being obvious to a person skilled 'P' document published prior to the international filing date but in the 3“- laterthan the priority date claimed '8.‘ document member of the same patent family Date of the actual completion of the international search Date of mailing or the international search report 02/04/2003 Authorized officer 18 March 2003 Name and mailing address of the ISA European Patent Office. P.B. 5813 Patentlaan 2 NL — 2280 HV Rijswijk Tel. (+31-70) 340-2040. Tx. 31 651 epo nl, Fax: (+31—70) 340-3016 Bridge, 5 Form PCT/ISA/210 (second sheet) (July 1992) page 1 of 2 INTERNATIONAL SEARCH REPORT lnternatio V ppllcation No PCT/E02/13012 c.(ContInuatlon) DOCUMENTS CONSIDERED TO BE RELEVANT Category ° Cltatlon of document, with indicatIon,where appropriate, of the relevanl passages Relevant to claim No. US 6 039 753 A (MEISLIN ROBERT) 21 March 2000 (2000-03-21) figures US 5 954 747 A (CLARK RON) 21 September 1999 (1999-09-21 the who1e document - Form PCT/|SAl21D(con1inualion of second sheet) (July 1992) page 2 of 2 intern 2;; al application No. ‘LT/EP 02/13012 INTERNATIONAL SEARCH REPORT Box I Observations where certain claims were found unsearchable (Continuation of item 1 of first sheet) This International Search Report has not been established in respect of certain claims under Article 17(2) (a) for the following reasons: 1. Claims Nos.: 10—_16 - _ ‘ because they relate to subject matter not required to be searched by this Authority, namely: Rule 39.1(iv) PCT — Method for treatment of the human or animal body by surgery 2. Claims Nos.: 9 because they relate to parts of the international Application that do not comply with the prescribed requirements to such an extent that no meaningful international Search can be carried out, specifically: see FURTHER INFORMATION sheet PCT/ISA/210 8. El Claims Nos.: because they are dependent claims and are not drafted In accordance with the second and third sentences of Rule 6.4{a). Box ll Observations where unity of invention is lacking (Continuation of item 2 of first sheet) This international Searching Authority found multiple inventions in this international application, as follows: As all required additional search fees were timely paid by the applicant, this international Search Fleport covers all searchable claims. As all searchable claims could be searched without effortjustifying an additional fee, this Authority did not invite payment of any additional fee. 3. D As only some of the required additional search fees were timely paid by the applicant, this international Search Report covers only those claims for which fees were paid, specifically claims Nos.: No required additional search fees were timely paid by the applicant. Consequently, this international Search Report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.: Remark on Protest CI The additional search fees were accompanied by the applicant's protest. E] No protest accompanied the payment of additional search fees. Form PCT/ISA/210 (continuation of first sheet (1 )) (July 1998) International Application No. PCTIEP 02 /13012 FURTHER INFORMATION CONTINUED FROM PCTIISAI 210 Continuation of Box I.2 Claims Nos.: 9 Present claim 9 relates to an extremely large number of possible compounds and products. In fact, the claims contain so many options, variables, possible permutations and provisos that a lack of clarity (and/or conciseness) within the meaning of Article 6 PCT arises to such an extent as to render a meaningful search of the claims impossible. Consequently, the search has been carried out for those parts of the application which do appear to be clear (and/or concise), namely claims 1-8, 17 and 18. ‘ ' The applicant’s attention is drawn to the fact that claims, or parts of claims, relating to inventions in respect of which no international search report has been established need not be the subject of an international preliminary examination (Rule 66.1(e) PCT). The applicant is advised that the EPO policy when acting as an International Preliminary Examining Authority is normally not to carry out a preliminary examination on matter which has not been searched. This is the case irrespective of whether or not the claims are amended following receipt of the search report or during any Chapter II procedure. INTERNATIONAL SEARCH REPORT Publication date NO 0049950 A Patent document cited in search report 31-08-2000 Patent famlly member(s) 6409974 B1 735951 B2 4829697 A 9705514 A 2224366 A1 1194817 A 0847727 A1 10179598 A 0049950 A1 6152935 A 6156044 A 2047800 A 1056397 A1 2002537058 A 6375924 lntematio PCT/EP 02/13012 ppllcation No 25-06-2002 19-07-2001 18-06-1998 07-12-1999 11-06-1998 07-10-1998 17-06-1998 07-07-1998 31-08-2000 28-11-2000 05-12-2000 14-09-2000 06-12-2000 05-11-2002 23-04-2002 EP 0608139 A ‘ 27-07-1994 5468253 A 662460 B2 5385294 A 2113792 A1 69423526 D1 69423526 T2 608139 T3 0608139 A1 2143525 T3 1002642 3 6277274 A 608139 T 5713920 21-11-1995 31-08-1995 28-07-1994 22-07-1994 27-04-2000 20-07-2000 03-07-2000 27-07-1994 16-05-2000 12-03-1997 04-10-1994 30-06-2000 03-02-1998 2002509753 T 3812099 2326125 A1 9949792 A1 1067873 A1 18-10-1999 07-10-1999 07-10-1999 17-01-2001 02-04-2002 Form PCT/ISA/210 (pateni family annex) (July 1992)