"set for securing tissue or a prosthetic element in an opening provided in a human or animal bon

专利摘要:
ASSEMBLY TO HOLD TISSUE OR A PROSTHETIC ELEMENT IN AN OPENING PROVIDED IN A HUMAN OR ANIMAL BONE. The present invention relates to a graft (1) or suitable prosthetic element, for example, to replace a tendon or ligament that is attached to a bone tunnel or blind opening with the aid of a fastener (3). In a first step, the graft (1) or prosthetic element is fitted by pressure in the tunnel or opening, forcing the fastener (3) into the opening or positioning the fastener in the opening and then expanding it, with the fastener (3) it is in contact with the graft (1) or prosthetic element and with the bone wall of the tunnel or blind opening. In a second step, the fastener (3) is anchored to the bone wall of the tunnel or blind opening. In a second step, the fastener (3) is anchored to the bone wall of the tunnel or blind opening with the help of a liquidizable material that is liquefied in the vicinity of the bone wall where it is in contact with the fastener and causing the liquefied material penetrates the bone wall. For the second stage, an anchor element (6) that comprises the liquefiable material is advanced in relation to the fastener (3) and the energy, (...).
公开号:BR112012018010B1
申请号:R112012018010-0
申请日:2011-01-19
公开日:2020-10-13
发明作者:Jorg Mayer；Milica Berra；Andrea Mueller；Stephanie Goebelmehl；Andreas Wenger；Elmar Mock
申请人:Sportwelding Gmbh；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The invention relates to the field of orthopedic surgery and relates to a method for securing a tissue or a corresponding prosthetic element in an opening provided in an animal or human bone. The invention additionally relates to a fastener that is suitable for the method.
[0002] The tissue or prosthetic element to be fixed, with the help of the method and fastener according to the invention, in an opening provided in an animal or human bone has the function of a soft tissue and is, in particular, a ligament or tendon graft (for example, bone-tendon-bone graft or tendon graft with at least one sutured end) or an artificial ligament or partial tendon or substitute to replace or strengthen a torn or otherwise defective tendon or ligament , but that tissue can also be a natural tendon or ligament to be re-coupled to a bone from which it was uncoupled by injury or surgery. This means that the corresponding prosthetic tissue or element is, in particular, a soft tissue, a soft tissue graft or a soft tissue substitute or partial substitute, which may, however, when attached to the bone, comprise a piece of a bone tissue or a corresponding replacement material, which is attached to the soft tissue and which in this case is trapped in the opening. One or both ends of the corresponding tissue or prosthetic element to be attached can be strengthened or, in particular, in the case of a graft comprising a plurality of filaments, they can be retained together by sewing, where the suture ends extending to away from the graft can also be used for graft positioning and tensioning.
[0003] The opening provided in the bone for clamping is, in a way known per se, a tunnel that leads through the bone or a blind opening that extends within the bone of a bone surface and that comprises within the bone a closed end. This opening is preferably provided by perforation, but it can also be provided by, for example, punch (for example, ultrasonic punch), that is, that opening will often have a non-circular or circular cross section that remains constant over the most of the depth of the opening, but that is not a condition for the invention. The opening can also be a plurality of sections with different cross sections, it can have a conical shape, or it can be a lower cut, (for example, made by grinding which allows the production of three-dimensional geometries within the opening).
[0004] An exemplary application of the method and fastener according to the invention is the replacement of a ruptured anterior cruciate ligament (ACL) in a human knee with a graft which is attached on one side in an opening that extends from the tibial plate and on the other hand in an opening that extends from the articular surface of the distal femur end. BACKGROUND OF THE INVENTION
[0005] According to the state of the art, a ruptured anterior cruciate ligament is replaced, for example, by a graft, such as, for example, a patellar tendon graft comprising two blocks of terminal bone, a hock tendon graft (semitendinosus tendon, possibly combined with gracile tendon), usually being left over and sutured in the extremity region, that is, it does not comprise blocks of terminal bone, or a quadriceps tendon graft, which is usually harvested with a block of terminal bone. The named grafts are usually autografts, but they can also be donor grafts (allografts). Donor grafts can also be made from Achilles tendons. It is proposed, in addition, to use synthetic tapes (in this document called "artificial grafts") and tendon material properly treated from slaughtered animals (xenografts), for example, pigs. The named autografts and allografts can, in addition, be reinforced with synthetic material and be combined with bone grafts or synthetic bone substitutes.
[0006] The end regions of all named grafts (autografts, allografts, xenografts and artificial grafts) need to be attached to the tibia and femur, for whose purpose, a tunnel or blind hole is provided in either of the two bones. The blind hole originates from the joint surface and ends within the bone. The tunnel has a first mouth located on the articular surface and a second mouth which is not located on the articular surface, where the first mouth and the adjacent tunnel portion may have a larger cross section than the second mouth and the adjacent tunnel portion. To attach the graft to the provided opening, a plurality of types of fastener are known.
[0007] A tunnel allows it to be attached to an internal bone wall of the tunnel (internal fixation) and / or in the vicinity of the second tunnel mouth (external fixation), a blind opening only allows internal fixation. According to the state of the art, internal fixation in a bone opening is carried out, for example, with the aid of an interference screw, which is screwed into the opening when the graft is positioned in this; with the aid of a non-expandable or mechanically expandable non-threaded snap-in element, which is forced without rotation into the opening when the graft is positioned in this or with the graft; or with the aid of a crosshead pin which is implanted at an angle to the geometric axis of the opening and engages, for example, a folded end of the graft or a suture loop attached to the graft end. In blind openings, internal fixation can also be performed with the aid of a bone screw that comprises a head section to which the graft is attached (hook screw) and which is screwed into the bottom of the blind opening. Internal fixation in a tunnel is usually completed by closing the second tunnel mouth with a bone plug or similar prosthetic element. Various devices and methods for internal fixation are described, for example, in publications US-5454811 and US-6099530 (both for Smith & Nephew), EP-0317406 (Laboureau), or US-2009/222090 (Mayr).
[0008] External fixation (fixation in the air of a second tunnel mouth not located on the articular surface), according to the state of the art, is carried out, for example, with the aid of a button through which the graft is bent or a suture loop attached to a graft end is threaded and which is larger than the cross section of the second mouth, or with the aid of a bone screw or similar anchor element, which retains the attached graft or suture ends to this and is screwed or impacted inside the bone in the vicinity of the second tunnel mouth. Such an external fixation is also proposed to reinforce an internal fixation inside the tunnel.
[0009] For an internal fixation in a bone tunnel or blind opening with the aid of a fastener such as an interference screw or a pressure fitting element, the graft or an end portion of the graft, respectively, is pressed against one side of the opening, when the fastener occupies the other side of the opening. This so-called external graft fixation is mainly used for grafts of a filament and for grafts that comprise the terminal bone block, but it can also be used for multifilament grafts. For grafts that comprise two by, for example, being folded, the fastener can also be positioned between the filaments, separating them from each other, in which the separate filaments are pressed against opposite walls of the bone opening. Such fixation is called internal graft fixation. Internal graft fixation is also used for grafts of four or more than four filaments, in which the graft filaments are pressed against the bone opening wall, preferably substantially and regularly spaced around the fastener and where, between filaments neighbors, the fastener may or may not be in contact with the bone wall of the opening. Internal graft fixation is proposed, in particular, for the graft end at which the filament or filaments are folded.
[0010] The publication WO 2006/023661 (Scandious Biomedical) discloses a large number of known methods of fixing ACL, in particular, fixing the internal graft with the aid of snap-on fasteners which are additionally attached to the tunnel of bone or blind hole.
[0011] The quality of more internal graft fixations is, in particular, dependent on the interface between the graft and the fastener on the one hand and between the graft and the opening wall on the other hand, but in most cases it is also dependent on the interface between the fastener and the opening wall, where good primary stability is desired at all named interfaces and good long-term stability, in particular, at the interface between the graft and bone tissue (good integration of the graft into the natural tissue by growth of natural tissue after the fixation operation). It is observed that the quality of fixation is additionally dependent on the location of fixation in the opening, in which fixation so close to the articular surface seems to be advantageous. To shorten convalescence, good primary stability is desired, for good long-term stability, bone growth in the opening. To allow maximum bone growth at the opening, interference screws and bioresorbable pressure fitting elements are proposed. In addition, it is important that the fastener causes as little damage as possible to the graft, either when it is being implanted, or later, and that the graft causes the least possible enlargement or other damage to the opening mouth, in particular, to the in which case that mouth is located on an articular surface.
[0012] The most common failures of known soft tissue fixation methods are caused by tissue or graft damage through interference screw wires which can lead to graft or tissue disruption, graft or tissue slip due to relaxation of a corresponding pressure fitting, or fastener migration on the first load, for example, due to compression of bone tissue in response to anchoring elements such as, for example, enlargements, which can lead to loss of tension in the graft or soft tissue .
[0013] The known fixation of ligaments other than the anterior cruciate ligament (graft or prosthetic element, or reattachment of natural ligament), tendons (graft or prosthetic element, or reattachment of natural tendon), or others, mainly soft tissues (graft or prosthetic element, or repair) in a bone opening provided for fixation, with the aid of a fastener is based on the same principles as the known fixations described briefly used to attach ACL grafts to openings provided in the tibia and femur. Such fixations are, for example, used in surgical procedures in relation to the human ankle or foot, such as, for example, lateral ankle reconstruction, Tendon transfer (long flexor toes), transfer of FHL tendon (long flexor of the toe). hallux), or flexor for tendon transfer (second finger); surgical procedures in relation to the human hand such as, for example, interposition of tendon reconstruction ligament, reconstruction of scapholunate ligament, reconstruction of collateral ligament, or repair of UCL (ulnar collateral ligament) of the thumb (also known as "hunter's thumb" ”); surgical procedures in relation to the human elbow such as, for example, repair of UCL (ulnar collateral ligament), or repair of the distal biceps tendon; or surgical procedures in relation to the human shoulder such as, for example, repair of the proximal biceps tendon. An additional example is the repair of damaged or broken cranial cruciate ligaments (CCL) in knee joints of dogs, in particular, but also, for example, cats. The CCL is the knee ligament most commonly damaged in dogs and the named repair is performed, for example, with the use of nylon strips which are passed around the fabella bone at the back of the femur and are fixed in a hole in the frontal part of the tibia. The same as known fastening methods, the fastening according to the invention is suitable for all named applications. SUMMARY OF THE INVENTION
[0014] The purpose of the invention is to create an additional method and fastener for attaching tissue or a corresponding artificial element (to be understood as: autograft, allograft, xenograft, or corresponding prosthetic element that replaces natural tissue, or fixation repair of natural tissue) inside an opening (“internal fixation” inside one or inside a blind opening) provided in an animal or human bone, in which method and fastener, according to the invention, must be simple and suitable for number large number of different types of tissues and prosthetic elements as well as for a large number of different types of applications and operating techniques (in particular, arthroscopic surgery) without the need for substantial adaptation. In particular, the methods and fasteners, according to the invention, must be suitable without substantial adaptation to be used in anterior cruciate ligament replacement surgery with the use of any type of graft (autograft, allograft, xenograft or artificial graft from a filament, two filaments or multifilaments, with or without a terminal bone block or corresponding artificial graft part and with or without portions of the sutured end).
[0015] The named objects are reached by the method and fastener as defined in the attached claims.
[0016] The fixation produced with the method and fastener, according to the invention, is an “internal” fixation (the fastener is positioned in the tunnel or blind opening and fastens the fabric to the wall inside the opening) and is basically a combination to snap the graft into the opening by using a fastener which locks the graft against a first portion of the opening wall and subsequently anchoring the fastener to a second portion of the opening wall by establishing a positive fitting connection between the anchor and this second wall portion. This means that the press fit and the positive fit are carried out one after the other, separated locally from each other and completely independent from each other.
[0017] The pressure fitting connection is achieved in a way known per se with the use of a fastener sized to be forced into the opening (corresponding size of the fastener and opening) or with the use of a fastener which is positioned in the opening and is then expanded, in which the force or positioning of the fastener in the opening is realized either when the fabric or artificial element to be fastened is already positioned in the opening or in conjunction with it and where the force or positioning without rotation of the fastener is preferred , but not a necessity. The fabric or artificial element to be fastened is arranged in the opening so that it does not cover the entire wall of the opening and the fastener is oriented so that a fastener portion equipped to achieve the positive fitting connection faces a wall portion. not covered by the fabric.
[0018] The positive fitting connection is achieved with the aid of an anchoring element that comprises a material capable of being liquefied by application of energy (preferably a material that has thermoplastic properties), by liquefying the material in situ so that the liquefied material is able to penetrate, preferably the trabecular structure of the bone tissue of the opening wall, where in resolidification it constitutes an anchorage in the form of a positive fitting connection. The anchor element is positioned in relation to the fastener, before or after pressing the fastener into the opening and is then advanced in relation to the fastener using an anchoring tool which simultaneously transmits the energy necessary for liquefaction to the anchor element or to the fastener. To avoid possible weakening of the pressure fitting established before the anchoring process, the force used to advance the anchoring element needs to be small when compared to the force used to establish the pressure fitting and / or needs to be neutralized so that it does not push the fastener in a direction in which it was forced into the opening.
[0019] It is also possible to treat, first, the bone wall of the opening with a first portion of material that liquefies so that the trabecular structure of that wall is penetrated and thereby reinforced by the material that liquefies and only then pressurizes the fastener and the graft in the opening and carry out the anchoring step described above, in which a second portion of material that liquefies is welded to the pre-treated wall of the opening. This two-step anchoring procedure results in the same positive fitting connection as the single-step procedure described above if the first and second portions of material that liquefies comprise the same material that liquefies. However, the first and second portions may comprise different liquefiable materials on the condition that two materials are welded together under the conditions of the anchoring step. To achieve good anchorage, it may be advantageous or even necessary to provide, in addition to or in place of pores or cavities in the trabecular network of bone tissue, additional cavities in the bone wall of the opening to be filled with liquefied material (for example, form of a lower cut of the opening in bone tissue).
[0020] To separate functions of pressing fastener (pressure fitting connection with the tissue to be fastened) and anchoring (positive fitting connection with bone tissue of the opening wall), the fastener, according to the invention, comprises portions separate surface units equipped for the pressing function or the anchoring function. Surface portions equipped for the pressing function may, in a shape known per se, have a concave or flat shape (shallow groove) and be rough or otherwise structured to retain the tissue to be attached, but may also lack in any specific shape or structure. The surface portions equipped for the anchoring function comprise means for guiding the material that liquefies comprised by the anchor element of the fastener inside or the fastener face proximal to those surface portions and they may additionally comprise couplings, wires, edges of widening or cutting or other structures known by themselves for additional support of the fastener in the bone wall of the opening.
[0021] In a preferred fastener mode, the surface portions equipped to press or anchor constitute sectors of a circumferential surface, in which a fastener suitable for fixing an external graft comprises a pressing sector and an anchoring sector and a suitable fastener for fixing an internal graft, it comprises a plurality of such sector pairs. Alternatively, fastener surface portions equipped to press or anchor can be arranged side by side along a fastener axis, or such alternately arranged surface portions can be provided on the fastener in addition to the named surface sectors above.
[0022] The fastener, according to the invention, has, for example, a general shape of a cylinder, trunk or cone (continuous or in stages), preferably, but not necessarily with substantially circular cross sections, that is, it is suitable to be fitted within an opening of a substantially circular cross section (cylindrical or continuous or stepped), but may also have another shape, such as, for example, a parallelepiped or wedge. A fastener according to the invention in the form of a substantially circular cylinder, trunk or cone may comprise in addition to the medium named above to guide the material that liquefies and possibly the medium to accommodate the graft, a wire that extends to the around the entire circumference of the fastener or around only part of it.
[0023] The method according to the invention basically comprises four steps: (a) providing a fastener and at least one anchoring element comprising a material that liquefies and providing an opening in a bone (for example, by retrograde drilling and anterograde or by puncture), in which the fastener and the opening are adapted to each other and to the graft (comprised to include natural fabric and a corresponding artificial element) to be attached, (b) press the graft into the opening, where the graft must not cover the entire internal wall of the opening, and the snap fit is performed by forcing (or positioning and expanding) the fastener inside the opening after positioning the graft or together with the graft, and (c) anchoring the fastener in the bone tissue of the opening wall by positioning the at least one anchor element in relation to the fastener and by transferring energy to the material that liquefies comprised by the anchor element and that advances simultaneously, the anchor element in relation to the fastener and thereby liquefy at least part of the anchor element and causing it to penetrate inside the opening wall (or be welded to the pre-treated opening wall), where this wall is not covered by the graft, and (d) let the liquefied material re-solidify on the opening wall.
[0024] The main advantages of fastening, according to the invention, is an improvement of the primary stability of the fastening as compared to pressure snap fasteners as, for example, described by H.O. Mayr et. al. in “Axial load in case of press-fit fixation of ACL graft - a fundamental study” (Z Orthop Ihre Grenzgeb, 143 (5): 556 a 60 (2005)) and “Beta-tricalcium plugs for press-fit fixation in ACL reconstruction - a mechanical analysis in bovine bone ”(Knee 14 (3): 239 to 44 (2007)). Compared with known fixation using an interference screw, fixation according to the invention is possible with substantially reduced danger of mechanically damaging the graft to be attached and is substantially less dependent on the mechanical properties of the bone tissue in which the opening is provided (allowing fixation on, for example, bone tissue weakened by osteoporosis), because the material that liquefies is capable of additionally strengthening that bone tissue. Compared in addition to the interference screw fixation, the fixation, according to the invention, preferably uses a cordless fastener and, therefore, of a smaller diameter, which allows a plurality of fasteners to be implanted next to each other. This means that, for example, an ACL graft can be fixed in more than one opening that results in a fixation of a wider footprint and, therefore, closer to remembering the natural ACL fixation.
[0025] In addition, fixation, according to the invention, can be performed without placing a critical thermal load on the graft to be attached and is therefore suitable for such a graft which is not only mechanically sensitive, but also thermally .
[0026] As already mentioned above, the anchoring technique applied in the method according to the invention is based on the liquefaction in situ of a material that liquefies, in particular, of a material that has thermoplastic properties. Such anchoring techniques and gripping devices that are suitable for such anchoring techniques are disclosed, for example, in publications US-7335205, US-7008226, US 2006/0105295, US-2009/131947, WO-2009/132472, WO -2008/034276, WO-2010/127462, and WO- 2010/045751, as well as in US Provisional Application US-61/259383, which is not yet published. The entire description of all named publications and applications is enclosed in this document for reference.
[0027] The main features of the named implant techniques are the in situ liquefaction of a material that liquefies, penetration of the liquefied material into a hard tissue surface (trabecular structure and / or suitable structures or cavities provided on the tissue surface hard) and re-solidification of the material that liquefies on the hard tissue surface. In this case, the material that liquefies is preferably a material that has thermoplastic properties, and that is capable, in its solid state, of transmitting energy and, in its liquefied state, of penetrating a similar porous or trabecular structure. Proper liquefaction connected with an acceptable fabric thermal load is achievable by using materials with thermoplastic properties that, preferably, have an elastic modulus of at least 0.5 GPa and a melting temperature of up to about 350 ° C and by liquefying only minimum necessary amount of material. The energy applied for such liquefaction is preferably mechanical vibration energy of a frequency, preferably in the range of between 2 and 200 kHz (preferably ultrasonic vibration with a frequency preferably between 15 and 30 kHz, with even more preference between 20 and 25 kHz) kHz), in which the material that liquefies and possibly other portions of the fastener or anchoring element transmit the vibration, preferably with very little damping to locations where the material that liquefies, for example, vibrates against an opposite element, being that , thereby, causes friction and thereby liquefaction.
[0028] Instead of using vibrational energy to create the local thermoenergy required for the liquefaction of material with thermoplastic properties, it is also possible to explore other types of energy, in particular, rotational energy transformed into frictional heat in substantially the same way as energy vibrational, or electromagnetic radiation (in particular, laser light in the infrared or visible frequency range), which radiation is preferably guided through the material with thermoplastic properties and absorbed locally by an absorber that is contained in the material with thermoplastic properties or that is arranged adjacent to that material. Electricity can also be used.
[0029] The suitable liquefiable materials for the anchoring element used in the fixation method, according to the invention, are thermoplastic polymers, for example: resorbable polymers such as polymers based on glycolic and / or lactic acid (PLA, PLLA, PGA , PLGA etc.) or polyhydroxy alkanoates (PHA), polycaprolactone (PCL), polysaccharides, polydioxanes (PD) polyanhydrides, polypeptides or copolymers or corresponding composite materials that contain the named polymers as a component; or non-resorbable polymers such as polyolefins (for example, polyethylane), polyacrylates, polymethacrylates, polycarbonates, polyamides, polyester, polyurethanes, polysulfones, polyarylketones, polyimides, polyphenyl sulfides or liquid crystal polymers (LCPs), polyacetals, polyacetals, polyacetals, polyacetals , in particular, halogenated polyolefins, polyphenylene sulfide, polysulfones, polyethers or equivalent copolymers or composite materials containing the named polymers as a component.
[0030] The specific modalities of degradable materials are Polylactides such as LR706 PLDLLA 70/30, R208 PLDLA 50/50, L210S, and PLLA 100% L, all by Bõhringer. A list of suitable degradable polymer materials can also be found at: Erich Wintermantel und Suk-Woo Haa, “Medizinaltechnik mit biokompatiblen Materialien und Verfahren”, 3. Auflage, Springer, Berlin 2002 (hereinafter referred to as “Wintermantel”), page 200; for information on PGA and PLA see pages 202 ff., on PCL see page 207, on PHB / PHV copolymers, see page 206; on polydioxanone PDS, see page 209. The discussion of a bioresorbable material can, for example, be found in CA Bailey et al., J Hand Surg [Br], April 2006; 31 (2): 208 to 12.
[0031] The specific modalities of non-degradable materials are: Polyetherketone (PEEK Optima, Degrees 450 and 150, Invibio Ltd), Polyetherimide, Polyamide 12, Polyamide 11, Polyamide 6, Polyamide 66, Polycarbonate, Polymethylmethacrylate, Polyoxymethylene, Polycarbonatourethane (in particular , DSM bionate, in particular, type 65D and 75D). A general table of polymers and applications is listed in Wintermantel, page 150; specific examples can be found in Wintermantel page 161 ff. (PE, Hostalen Gur 812, Hõchst AG), pages 164 ff. (PET) 169ff. (PA, namely PA 6 and PA 66), 171 ff. (PTFE), 173 ff. (PMMA), 180 (PUR, see table), 186 ff. (PEEK), 189 ff. (PSU), 191 ff (POM-Poliacetal, trade names Delrin, Tenac, were also used in endoprostheses by Protec).
[0032] The material that liquefies which has thermoplastic properties may contain foreign phases or compounds that serve other functions. In particular, the thermoplastic material can be strengthened by vibrissae and fibers mixed by addition (for example, glass or calcium phosphate ceramics) and represents a composite material. The thermoplastic material can additionally contain components which expand or dissolve (create pores), in situ (for example, polyesters, polysaccharides, hydrogels, sodium phosphates), compounds which yield the opaque melting device and, with that, visible by X-ray, or compounds to be released in situ that have a therapeutic effect, for example, promoting healing and regeneration (for example, growth factors, antibiotics, inflammation inhibitors or buffers such as sodium phosphate or calcium carbonate against adverse effects of acid decomposition). If the thermoplastic material is resorbable, the release of such compounds is delayed. If the device is to be anchored not with the help of vibrating energy, but with the help of electromagnetic radiation, the liquefied material that has thermoplastic properties may contain compounds locally (particulate or molecular) which are capable of absorbing such radiation from a specific frequency range (in particular, the infrared or visible frequency range), for example, calcium phosphates, calcium carbonate, sodium phosphates, titanium oxide, mica, saturated fatty acids, polysaccharides, glucose or mixtures thereof .
[0033] The fillers used can include osseo-stimulating and degradable fillers to be used in degradable polymers, which includes: p-Tricalcalciophosphate (TCP), Hydroxyapatite (HA, <90% crystallinity; or mixtures of TCP, HA, DHCP, Bioglasses ( see Wintermantel.) Bone integration stimulation fillers that are only partially or hardly degradable, for non-degradable polymers include: Bioglass, Hydroxyapatite (> 90% crystallinity), HAPEX®, see SM Rea et al., J Mater Sci Mater Med ., September 2004; 15 (9): 997 to 1,005; for hydroxyapatite, see also L. Fang et al., Biomaterials, July 2006; 27 (20): 3,701 to 7, M. Huang et al., J Mater Sci Mater Med, July 2003; 14 (7): 655 to 60, and W. Bonfield and E. Tanner, Materials World, January 1997; 5 nos. 1:18 to 20. Modalities of bioactive fillers and their discussion can, for example, be found in X. Huang eX. Miao, J Biomater App., April 2007; 21 (4): 351 to 74), JA Juhasz et al. Biomaterials, 2004 Mar; 25 (6): 949 to 55. Types of particulate filler include: rough type: 5 to 20pm (contents of, preferably, 10 to 25% by volume), submeron (nanopre-fillers as from precipitation, preferably aspect ratio similar to plate> 10, 10 to 50 nm, contents of 0.5 to 5% by volume). The experiments show that liquefaction with the help of ultrasonic vibration energy allows the filling of the thermoplastic polymer to a relatively high degree without impairing the ability of the liquefied material to penetrate structures such as the viable spongy bone trabecular structure. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The exemplary modalities of the method and the fastener according to the invention are described in detail in connection with the attached figures, in which:
[0035] figure 1 illustrates the invention showing six consecutive phases of an exemplary external graft fixation in a bone tunnel using an exemplary method of the method according to the invention;
[0036] figure 2 shows four consecutive phases of an exemplary ACL replacement surgery using the method shown in figure 1;
[0037] figures 3 and 4 illustrate two additional exemplary applications of graft fixation according to the invention, in a bone tunnel comprising a portion of a reduced diameter (figure 3) or in a blind hole (figure 4);
[0038] figures 5 to 9A / B show additional exemplary sets comprising a fastener, anchoring element and an anchoring tool, the sets being suitable for the method of fixation according to the invention;
[0039] figures 10 to 17 are three-dimensional illustrations or axial sections of additional exemplary fastener modalities that are suitable for methods similar to those illustrated in figures 1 and 5;
[0040] figures 18 to 22 are cross-sections through grafts that are fixed with the method according to figures 1,5,6 or 7 in a bone tunnel or blind hole with the aid of additional exemplary fastener modalities;
[0041] figure 23 shows an embodiment of the method according to the invention that includes a pre-treatment step in which the opening wall is treated with a first portion of material that liquefies before the fastener is introduced;
[0042] figure 24 shows an embodiment of the method according to the invention, in which an expandable fastener is used;
[0043] figure 25 illustrates an additional exemplary embodiment of the method according to the invention, the method being suitable for fixing an external graft in a bone tunnel or in a blind opening;
[0044] figure 26 shows an additional exemplary embodiment of the method according to the invention, the method being suitable for fixing an external graft in a blind opening;
[0045] figures 27 to 33 are cross sections and three-dimensional representations of exemplary fastener modalities suitable for fixing an internal graft using a method similar to that illustrated in figures 1 or 5;
[0046] figures 34A / B show an exemplary embodiment of a set according to the invention, the set comprising the fastener, the anchoring element and the anchoring tool and is suitable for fixing an internal graft using a method similar to that illustrated in figures 6 or 7;
[0047] figures 35A / B show an exemplary embodiment of a set according to the invention, the set comprising the fastener, the anchoring element and the anchoring tool and is suitable for fixing an internal graft using a method similar to that illustrated in figure 25;
[0048] figure 36 shows an area of occupation of a fixation of a graft of two filaments according to the invention, whose area of occupation is particularly suitable for fixation of tibial ACL;
[0049] figures 37, 38A / B and 39A / B / C show fastener sets, anchor element, anchor tool and guide tool, in which the guide tool is suitable not only to guide the anchor tool during the anchoring process, but also to form the fastener into the opening along a guidewire to establish snap fit before the anchoring process is initiated.
[0050] Items that have the same function and similar items are named in all figures with the same reference numerals. DESCRIPTION OF PREFERENTIAL MODALITIES
[0051] Figure 1 shows six consecutive (a) to (f) the fixation (fixation of external graft) of a soft tissue in a bone tunnel using exemplary modalities of the method and fastener according to the invention. The soft tissue is, for example, a graft 1, which, as seen in step (a), is positioned to extend through tunnel 2 and, if applicable, is maintained with measures known to you at a desired tension during the process fastening. However, neither the method nor the fastener needs to be different to attach a prosthetic element or a natural soft tissue to the tunnel, where the graft or soft tissue may not extend through the tunnel, but has an end inside the tunnel and that end can comprise a terminal bone block. Obviously, in the latter case the opening can also be a blind opening, for example, a blind hole. In addition, the graft or soft tissue may comprise a sutured end portion with suture ends extending from it, where that end portion is positioned in the tunnel, with the suture end portions exiting through the second tunnel mouth and are used, for example, to stretch the graft or soft tissue (see also figure 3).
[0052] The fastener 3 is adapted in cross section to be able to snap the graft 1 into the tunnel 2. The fastener 3 comprises an internal cavity 4, which is, for example, substantially cylindrical, extending from the face proximal of the fastener towards the distal end of the fastener, and which is connected by a passage 5 or a plurality of passages to an anchoring sector of the circumferential surface of the fastener, that is, only one side of the fastener 3. The passage 5 can have the shape of one or a plurality of, for example, slit-shaped, round or polygonal fenestrations or of an otherwise perforated region (for example, material with an open porosity, for example, trabecular or sintered metal or ceramic) . The anchor element 6 is, for example, a pin-shaped item of a material that has thermoplastic properties, the material of which is suitable to be liquefied in the manner described above, with the anchor element fitting into the inner cavity 4 to reach at least in the region of passage 5.
[0053] The fixation process is preferably performed as follows: Graft 1 positioned through tunnel 2 as shown in (a) is impacted against one side of the tunnel wall by the introduction of an dilator 10 between the graft 1 and the opposite side of the tunnel wall as shown in step (b), in which a tapered dilator on one side 10 as illustrated and used with the tapered side facing the graft 1 is most effective. This impact compresses graft 1 or, if applicable, its terminal bone block. In phase (c), the dilator 10 is removed and the fastener 3 is forced (force F.1) into the space between the graft 1 and the tunnel wall whose space was prepared in the impact step. In the same, the passage 5 of the fastener 3 faces towards the wall of the tunnel opposite to the graft 1 and the fastener positioned 3 is to press fit the graft against the wall of the tunnel. To force the fastener 5 into the tunnel, for example, a pressure rod 11 that reaches the internal cavity of the fastener 4 is used. Instead of using the pressure rod 11 illustrated to force the fastener into the tunnel, a plunger tool that acts on the proximal face of the fastener face can also be used. In step (d), the pressure rod 11 is removed and a reamer 12 is inserted into the internal cavity of the fastener 4, its distal tip angled to reach the passage 5. The reamer 12 is alternated to widen the tunnel wall outside the passage 5. In step (e), the reamer 12 is removed and the anchor element 6 is inserted into the internal cavity 4 and an anchor tool 13 is placed on the proximal face of the anchor element 6 or attached to it. It is also advantageous to position a guide tool 14, the guide tool being equipped to guide the anchor tool 13 and possibly the anchor element 6 to be able to be advanced exactly coaxially in the internal cavity 4. The anchoring tool 13 serves to produce the anchoring of the fastener through the anchoring element in the tunnel wall, that is, to transmit to the anchoring element 6 energy, for example, ultrasonic vibration, necessary for the liquefaction of the material that liquefies and an F.2 force to advance the anchor element 6 towards the distal end of the fastener, so that the material of the anchor element 6 is liquefied and, in a liquid state, is made to flow through the passage 5 in the bone tissue of the tunnel wall, where in re-consolidation it constitutes an anchor 15 of the fastener 3 in the bone tissue as shown in phase (f).
[0054] Obviously, in the method as illustrated in figure 1, the establishment of the pressure fitting (phase (c)) and the establishment of the anchoring (phase (e)) are performed one after the other and independently of each other, in which the force F.2, which is applied to the anchoring element to advance it in the anchoring step (phase (e)) is neutralized by fastener 3 and has the same direction as the force F.1 that is necessary to establish the fit by pressure (phase (c)), that is, it has no component in a force of opposite direction F.1 and, therefore, it cannot in any way weaken the fitting by pressing the graft or soft tissue through the fastener.
[0055] Depending on the cross section of the graft 1 in an non-impacted state, the impact step (phase (b)) can be omitted. The use of a tapered fastener or distal end of a tapered fastener can also make the impact step unnecessary. Depending on the density of the bone tissue in the tunnel wall and the desired anchorage strength, the enlargement step (phase (d)) can be omitted. Enlargement is advisable for very dense bone tissue. If the widening step is performed, the anchoring achieved in step (e) will be deeper and will reach the bone tissue that was not compacted by the pressure fitting. However, a similar effect can be achieved by equipping the fastener with an axial groove that extends from the distal end to the outer mouth of the passage 5. The guide tool 14 can be positioned at the proximal end of the fastener 3 before the widening step or even before the establishment of the pressure fitting, in which in the latter case, the guide tool is used to force the fastener 3 into the opening instead of the pressure rod 11. Depending on the advance travel of the anchor element necessary to reach the desired anchoring (phase (e)) and the guideability of the anchoring tool 13, the use of a guide tool 14 can be omitted.
[0056] It may be advantageous to use a guidewire to introduce the dilator 10 and / or the fastener 3 into the opening of the bone that needs a way in itself of an axial channel or hole (central or eccentric) in the dilator 10 and / or fastener 3. Experiments show that it is advantageous to supply the axial hole in the dilator 10 and / or fastener 3 as close as possible to the circumferential surface of the side that must face towards the opening wall. Instead of the hole, it is possible to provide a groove (preferably a lower cut) along the circumferential surface of the dilator and / or the fastener to guide them along the guide wire.
[0057] Figure 1 shows the fastener inserted in the opening of bone 2 with its proximal face being level with the surface of the bone. This, of course, is not a condition of the method according to the invention. Without changing the fastener and method, it is also possible to introduce the fastener further into the bone, so that the proximal end of the fastener is buried in the bone, or less distant, so that the proximal end of the fastener protrudes from the bone .
[0058] As already mentioned, the anchoring tool 13 is, for example, a vibration tool (for example, sonotrode connected to an ultrasonic transducer that is, for example, part of an ultrasonic device such as an ultrasonic handpiece) , which transmits ultrasonic vibration to the anchoring element 6 and is simultaneously pressed against the proximal face thereof or is rigidly fixed to it and pressed against the closed distal end of the fastener 3 together with the anchoring element. In such a case, it is advantageous to provide either in the anchoring element 6 or within the internal cavity 4 energy drivers (protruding points or edges) in which liquefaction is desired. Such an energy driver for the fastener 3 and for the anchor element 6 in the case illustrated is constituted by the tapered distal end of the anchor element 6. The alternative modalities of such energy drivers are, for example, edges or points that project in the internal cavity from the margin of the internal mouth of the passage 5. The additional modalities of such energy drivers are disclosed in provisional application No. US 61/259383 (not yet published), the description of which is incorporated herein in its entirety by way of reference.
[0059] The anchor tool 13 can also be equipped to transmit the rotational energy to the anchor element which is rigidly fixed to it, in which the heat necessary for the liquefaction of the material anchor element is in such case produced by friction between the distal face of the rotating anchor element and the internal non-rotating surface of the fastener. Alternatively, the anchoring tool 13 can be equipped to transfer electromagnetic energy (preferably in the visible or infrared frequency range) or electrical energy to the anchoring element 6 or to the fastener 3, where either the anchoring element 6 or the fastener regions in the vicinity of the anchoring element they need to be equipped to transform the transmitted energy into thermal energy, for example, comprising light absorption means or electrical resistance means.
[0060] If fastener 3 according to figure 1 is used to fix an external graft in a blind opening, it may be desirable to anchor it in addition to anchoring it in the circumferential wall of the opening also in the back wall of the opening or exclusively in the wall of the opening. opening bottom (see also figure 26). In such a case, the fastener needs to be inserted into the blind hole so that it substantially touches or at least gets close to the bottom wall of the opening and needs to comprise at least one passage 5 that connects the inner cavity of the fastener 4 with a distal face of the fastener, the passage of which is provided in addition to or in place of the lateral passage 5 shown in figure 1. Since the distal surface of the fastener is equipped for the anchoring fastener to constitute a portion of the fastener surface that is separate from the fastener surface portions equipped to press not as a circumferential sector (as described above for the surface comprising the lateral passage 5), but as an axial portion, as already mentioned above.
[0061] Fastener 3 is made of a material that may or may not be biologically resorbable as is known for fasteners according to the state of the art, which serve the same purposes. If the fastener is not resorbable, it is, for example, made of a metal (for example, titanium, titanium alloy, stainless steel), a ceramic material (for example, aluminum oxide, zirconium oxide), a phosphate of calcium or a polymer (for example, thermoplastic, for example, PEEK, possibly coated, for example, with an inner coating of titanium and an outer coating of hydroxyapatite). Although it seems advantageous to produce the fastener from a material that is not liquefied under the conditions of the anchoring process, experiments show that the fastener can also be made of a material that liquefies, even the same material as the material that liquefies. of the anchor element. Good results have been achieved, for example, with fasteners made of titanium or polylactic acid (PLA) filled with Hydroxyapatite or calcium phosphates, particularly PLLA filled with 60% tricalcium phosphate or 70% / 30% PDLLA (70 % L and 30% D / L) filled with 30% biphasic calcium phosphate, combined with PLDLLA anchoring elements 70% / 30% (70% L and 30% D / L), as available from Bõhringer as LR706 .
[0062] Particularly, in a case where the graft (or natural soft tissue or corresponding artificial element) to be attached is very sensitive to heat it is preferable for use, at least for a fastener region that must be located in the vicinity of the graft , a material that has some heat insulation characteristics. If the graft to be attached is less sensitive to heat (for example, artificial tissue replacement material), such a precaution is not necessary. For such non-heat-sensitive fabric that is additionally sufficiently deformable, it is even possible to provide passages 5 also directed to the side of the graft, in which for the anchoring process these passages will be closed by the compacted graft and will not allow or will hardly allow the passage of the liquefied material. (advantage: no specific swivel fastener orientation at the opening is required).
[0063] External graft fixation as illustrated in figure 1 can, for example, be achieved by providing a tunnel or blind hole 8 mm in diameter, a substantially cylindrical fastener 7 mm in diameter and a graft that has a portion sutured end that easily passes through a 7 mm diameter hole. The experiments show that the substantially cylindrical fasteners with a tapered distal end, particularly with a hemispherical end as shown in Figure 1 and with a circumferential surface of a roughness of no more than 10 pm in depth, generate a good pressure fit and can be inserted with reasonable forces, while fasteners with flat distal ends and / or greater surface roughness appear to require greater introducing forces, but do not result in a greater pressure fit. A stronger pressure fit is achieved with the use of longer fasteners.
[0064] Figure 2 shows schematically four consecutive phases (a) to (d) of an exemplary surgical procedure to replace an anterior cruciate ligament (ACL) in a human knee, in which the graft 1 used for the replacement comprises , for example, two terminal bone blocks and in which one of these terminal bone blocks is stuck in a blind hole 20 in the femoral bone 21 and the other in a tunnel 22 that reaches through the tibial bone 23. The procedure known per se comprises a femoral and tibial fixation process that can both be performed using the method according to the invention as, for example, illustrated in figure 1.
[0065] In phase (a), the tibial tunnel 22 and the femoral blind hole 20 are provided and the graft 1 is positioned for the fixation processes. In phase (b), femoral fastener 3.1 is snapped into the blind femoral hole 20. In phase (c), femoral fastener 3.1 is anchored to the wall of blind femoral hole 20 (anchorage 15.1). In phase (d), the tibial fastener 3.2 is fitted by pressure and anchored (anchoring 15.2) in the tibial tunnel 22.
[0066] Figure 3 shows, as mentioned above, the fixation of a sutured graft end 16 in the opening of bone 2 using a fixation method similar to that illustrated in figure 1. The opening of bone 2 is a tunnel and comprises a portion 2.1 of a larger cross section and a portion 2.2 of a smaller cross section, in which the sutured graft end 16 and the fastener 3 are arranged in the tunnel portion 2.1 and the suture ends 17 extending from the end of sutured graft 16 come out through the tunnel portion 2.2 and are, for example, sweat to tension the graft before compressing it with the dilator or introducing the fastener 3. The graft 1 comprising the sutured graft end 16 is, for example , a two-filament graft in which the two filaments are attached to each other by a series of transverse seams around both side sides and made with one, the two suture ends 17 projecting from the graft end sutured. Graft 1 can also be a four-filament graft that is produced by folding a two-filament graft in two with the two ends being sutured in the manner mentioned, the four-filament graft then comprising a folded end with suture ends and a sutured end with four suture ends protruding. The step of anchoring the fastener to the wall of the tunnel portion 2.1 is, for example, performed as described above in connection with figure 1.
[0067] Figure 4 shows the fixation of a sutured graft end 16 in an opening of the bone 2 which is the blind hole, in which the sutured graft end 16 is fixed to the fastener 3 preferably with the aid of the suture ends 17 protruding from the sutured graft end 16. This fixation is established prior to the introduction of the graft end 16 and the fastener 3 into the opening and the two are introduced together into the opening 2 to establish the snap fit. Figure 3 shows the end of the graft 16 and the fastener 3 positioned in the opening of the bone 2. The step of anchoring the fastener 3 in the opening wall is established, for example, as shown in figure 1.
[0068] The fixation of a sutured graft end to the fastener 3 can be achieved, for example, as shown in figure 4, by sewing a first part of the suture end 17 through the internal cavity 4 of the fastener 3, which stops this end comprises an open distal end and a second part of the suture ends 17 along the circumferential surface of the fastener 3 and provides a knot or other suitable suture retainer on the proximal face of the fastener to connect the two parts of the suture ends 17. The circumferential surface of the fastener and / or the internal cavity of the fastener may comprise a groove that extends axially to accommodate the suture ends. If the suture is heated to heat and there is a risk that the suture will be damaged by the liquefied material inside the internal cavity of the fastener, it will be advantageous to provide at least one separate tunnel through the fastener for the suture (see also figure 19). It is also possible to equip the distal end of the fastener 3 with an orifice or retention means similar to which the suture ends 17 projecting from the sutured graft end 16 can be properly fixed before the graft end 16 and fastener 3 are inserted into the opening of bone 2 together. It is also obviously possible to attach an unsutured graft end to the fastener in a suitable manner.
[0069] Figures 5 to 9A / B show additional exemplary types of fasteners 3 together with adapted anchor elements 6 and anchor tools 13, where all illustrated sets of fastener 3, anchor element 6 and anchor tool 13 are suitable for an anchoring step that is slightly different from the anchoring step illustrated in figure 1, but which are all suitable for the anchoring applications as shown in figures 1 to 4. Figures 5 to 9 illustrate the anchoring steps for the anchoring of external graft, but as discussed below, the principle is applicable for fixation of internal graft as well.
[0070] Figure 5 shows an axial section of a fastener 3 that is snapped into a bone tunnel 2 to attach a graft 1 to the bone tunnel. The fastener 3 is mainly the same as the fastener illustrated in figure 1, but according to the passage 5 that reaches from the internal cavity 4 to the outer surface of the fastener, a plurality of openings is provided instead of the fenestration type of a slit according to figure 1. The anchoring element 6 is in the form of a tube and rests loosely on the foot piece 25 of an extension 26 of the anchoring tool 13, which again is preferably a vibrating tool. For the anchoring process, the extension 26 together with the anchoring element 6 is inserted into the internal cavity 4 of the fastener 3. The anchoring tool 13 is then activated and the anchoring element 6 is retained and advanced against the foot piece 25 by applying a corresponding force F.2 to a counter element 27 acting on the proximal face of the anchoring element 6. The thermoplastic material comprised by the anchoring element 6 is liquefied on the distal face of the anchoring element 6 in which it is in contact with the footpiece of the vibration tool 25. By the corresponding positioning of the interface between the footpiece 25 and the anchor element 6 the liquefied material is made to flow through the passage 5 in the tunnel wall, where this interface is displaced to subsequent anchoring processes through different passages 5. Figure 5 shows the configuration during the anchoring process, in which the anchoring material has already been forced through a distant passage ai and average 5, in which the mentioned interface is positioned in the middle passage and in which a proximal passage is still free of the anchoring material.
[0071] With the combination of anchor element 6, anchor tool 13 and counter element 27 as shown in figure 5, the advance of anchor element 6 can also be made by attracting the foot piece 25 towards the proximal face of the fastener 3, while holding counter element 27 substantially stationary, for example, pressed against the bone surface. It is also possible to reverse the functions of the anchoring tool and counter tool, that is, to vibrate the counter element 27 and use the foot piece 25 as a counter element. In addition, for anchoring the fastener as illustrated in figure 5, as already mentioned for anchoring the fastener according to figure 1, it is also possible to use other types of energy than the vibration energy. Additional modalities and details of the principle of the anchoring process as illustrated in figure 5 are described in publication WO-2009/132472, the description of which is incorporated herein in its entirety for reference. In an alternative embodiment of the combination of anchor element 6 and anchor tool 13, as shown in figure 5, the tube-shaped anchor element 6 constitutes the consumable element in a dispenser-type device and is liquefied at a distal end of the device in a similar manner as shown in figure 5. Such dispensing devices are described in publication WO-2010/127462 whose description is incorporated herein in its entirety for reference.
[0072] It is obvious that in the fastening method as shown in figure 5, the F.2 force necessary to advance the anchor element 6 is not neutralized by the fastener 3. Therefore, this force cannot weaken the fitting by pressing the fastener, whatever its direction and this allows the use of a fastener that does not have a closed distal end and the introduction of the anchoring element from either the proximal or distal end of the fastener.
[0073] Figure 6 is an axial section of an additional set of fastener 3, anchor element 6 and anchor tool 13, in which fastener 3 is shown in the opening of bone 2 before the anchoring step, that is, engaged by pressure between the graft 1 and the opposite wall of the bone opening 2. Except as described above, fastener 3 does not comprise an internal cavity and passages that connect the internal cavity to the external surface of the fastener (as shown in figures 1 to 5) , but instead, to guide the material which liquefies compressed by the anchoring element 6 of a proximal face of the fastener to the anchoring portions of the circumferential surface of the fastener, the fastener 3 comprises at least one groove 30 extending from the proximal face of the fastener towards the distal end of the fastener and may have a slightly reduced cross section. The anchor element 6 is adapted to substantially fill this cross section and protrude slightly from it and is pressed into the groove 30 of the fastener snapped from the proximal face of the fastener with the aid of the anchor tool 13. In the even, the anchor element 6 is advantageously rigidly coupled to the distal end of the anchor tool 13, so that the vibration energy (or other type of energy) is transmitted substantially loss-free to the anchor element and liquefaction it occurs where the anchor element comes into contact with the bone tissue of the bone opening wall and possibly also where the anchor element comes into contact with the inner surface of the groove 30. The groove 30 may comprise a rough internal surface or another properly structured so that the liquefaction and re-consolidation of the anchor material can result in a positive plug connection o not only with the bone tissue of the bone wall, but at the same time also with the groove within the surface of the fastener 30.
[0074] If a fastener 3 according to figure 6 comprises more than one groove, anchoring the fastener requires more than one anchoring step, in which these anchoring steps can be performed in succession using one and the same tool anchoring for all steps, or where the anchoring steps can be performed simultaneously using a fork-shaped anchoring tool.
[0075] Figure 7 is an axial section through an additional embodiment of a fastener set 3, anchor element 6 and anchor tool 13, the set of which further comprises a guide tool 14 and is suitable for a similar anchoring process to that described in connection with figure 6. The set is illustrated with the fastener 3 snapped together with a graft 1 in an opening of the bone 2, the set being ready for the anchoring step. The guide tool 14 comprises an axial through hole having a cross section adapted to the cross section of the anchoring element 6 and to the distal end of the anchoring tool 13, in which the through hole is angled with respect to a geometric axis of the tool at an acute angle of 2 to 10 °, preferably 3 °. As already illustrated in figure 6, for the anchoring step, the anchoring element 6 must be advanced from the proximal face of the fastener along a groove 30 provided on the side of the fastener opposite to the graft 1. Except as shown in figure 6 , the groove 30 according to figure 7 comprises a wider entrance portion 30.1 and a narrower distal portion 30.2, wherein the distal portion preferably has a closed end. In preparing the anchoring step, the guide tool 31, which can also serve to force the fastener into the opening of the bone 2, is positioned on the proximal face of the fastener with the mouth distal from its through hole being aligned with the inlet portion the groove 30. The anchor element 6 and the distal end of the anchor tool 13 are positioned in the through hole of the guide tool 31, the distal end of the anchor element being supported on the inlet portion 30.1 of the groove 30. During the anchoring process, the anchoring element 6 is advanced in the groove 30, where the angled position of the anchoring element 6, as shown in figure 7, in comparison with the axial position, as shown in figure 6, forces the material of the anchoring element further against the wall of the bone opening and thereby accentuates liquefaction and penetration into bone tissue. This effect is amplified by the groove 30 which has a closed end.
[0076] The experiments show that the anchoring of a fastener that has a diameter of 8 mm and a distal portion of the groove 30.2 of a semicircular cross section of 1.5 to 2 mm radius with the use of an anchor element in the shape of 3.5 mm diameter pin generates good results.
[0077] Figure 8 is an axial section through an additional modality of a fastener set 3, anchoring element 6, and anchoring tool 13, where fastener 3 and a graft 1 are shown fitted by pressure in a tunnel bone before the anchoring step. The anchoring element 6 consists of an integrated central part of the fastener 3 which is, for example, completely made of the material that liquefies, where that material can comprise load compounds (blades, fibers, particles) whose concentration can decrease in a direction from the circumferential surface of the fastener towards the central region of the fastener that constitutes the anchoring element 6. The fastener comprises an internal cavity 4 in the form of an axial channel and at least one passage 5 that connects the channel with a sector anchoring the circumferential surface of the fastener. The channel preferably has a wider proximal portion 32 and a narrower distal portion 33, and the anchoring tool 13 adapted to the fastener 3 has at least one distal portion that is adapted to the wider portion of the channel 32 to be guided therein. The anchor element 6 consists of the fastener portion that surrounds the distal (narrower) portion of channel 33 and is advanced and liquefied by forcing the anchor tool 13 from the widest portion of channel 32 to the narrowest portion of the channel thus pressing the liquefied material through the passages 5 to the outer surface of the fastener. Additional modalities and details of the fastener and anchoring process as illustrated in figure 8 are described in publication US-2008/262517 (Stryker Trauma GmbH), the description of which is incorporated herein in its entirety for reference.
[0078] Figure 9A is an axial section through an additional modality of a set comprising a fastener 3, an anchor element 6 and an anchor tool 13, in which the fastener 3 is shown to be press fit to a graft 1 in an opening of bone 2, on the left side of the figure before the anchoring step and on the right side of the figure after the anchoring step. The modality can be considered to be a combination of the modality according to figures 6 and 8, that is, it comprises at least one anchor element 6 integrated in the fastener 3 that can completely consist of the anchor material, and that possibly contains a load which possibly has a lower concentration in which the material must be liquefied then in other areas, as discussed in connection with figure 8. However, except as shown in figure 8, the anchor element 6 or the material to be liquefied respectively does not it is located in a central area of the fastener, but on its circumferential surface, as discussed in connection with figure 6. The anchoring tool 13, which preferably has a tapered distal end, is forced into the fastener material parallel to the wall of the fastener. opening of the bone in the surface area of the material that liquefies. When, after completing the anchoring step, the anchoring tool is removed, it leaves a gap 15 'between a central area of the fastener and the anchoring 15 in the bone wall, which is connected to the rest of the fastener next to the gap 15' as clearly seen in figure 9B (cross section through anchored fastener 3).
[0079] Figures 10 to 17 show various types of fasteners 3 based on the fastener principle (fastener with internal cavity 4 connected to the circumferential surface of the fastener and the anchoring element adapted to fit the internal cavity of the fastener) as illustrated in the figures 1 to 5, but differing in shape. All of these fasteners 3 are applicable to the fastening methods and applications as shown in figures 1 to 5.
[0080] Figure 10 is a three-dimensional illustration of a very simple fastener 3 that has the shape of a circular cylinder with a round distal end. It comprises an internal cavity 4 and only a slot-shaped passage 5 that connects the internal cavity 4 with the circumferential surface of the fastener.
[0081] Figures 11 to 13 are three-dimensional illustrations of additional fasteners 3 similar to the fastener in figure 10. These fasteners comprise on the right side (anchoring sector of the circumferential surface of the fastener) the passages 5 that connect the circumferential surface of the fastener with the internal cavity 4. The passages are in figures 11 and 13 two rows of holes that extend axially (a visible row), in figure 12 a row that extends axially in cracks that extend substantially circumferentially. The fasteners of figures 11 to 13 also comprise on the left side (pressing sector 34 of the circumferential surface of the fastener) a flat or concave sector that forms a shallow groove to accommodate the graft to be attached. Additionally, the fastener of figure 13 comprises a ridge that extends axially 35 in the center of the pressing sector 34 whose ridge serves to retain a folded graft (not shown) that is folded over the distal end of the ridge 35 to be forced into the opening of the bone together with fastener 3 in a similar way to that discussed in connection with figure 4.
[0082] Figure 14 is an axial section of an additional fastener 3, the fastener is illustrated by pressing with a graft 1 into a bone opening and the figure further illustrates the anchoring element 6, the anchoring tool 13 and a guide tool 14 similar to the guide tool as discussed in connection with figure 7, the whole set being ready for the anchoring step. The fastener 3 comprises at least one channel 4/5 (combination of the internal cavity 4 and passage 5) which extends at an angle to the geometric axis of the fastener. The at least one channel 4/5 comprises a first mouth on the proximal face of the fastener that serves to introduce the anchoring element 6 and possibly a distal end of the anchoring tool and a second mouth on the circumferential surface of the fastener, which serves to press the anchoring material against the bone wall of the bone opening, in which the anchoring material is either liquefied within channel 4/5, which for this purpose preferably comprises internal energy drivers, or at the interface with the bone wall.
[0083] Figure 15 is an axial section of an additional fastener modality comprising an internal cavity 4 and a passage 5 in which the internal cavity 4 is arranged non-coaxial with the geometric axis of the fastener and comprises a step 4 'or a corresponding curve that is able to deflect the anchor element 6 towards the passage 5. This arrangement results in an effect of forcing the anchor material towards the fastener surface or the bone wall respectively in a similar manner as discussed in connection with figure 7.
[0084] Figure 16 is a side view of an additional fastener 3 comprising an internal cavity 4 and the passages 5 connecting the internal cavity with the circumferential surface of the fastener. The fastener comprises the distal and proximal end regions that have a larger cross-section than a middle region. The two end regions are particularly spherical. The experiments show that the fastener according to figure 16 provides a pressure fitting as good as a cylindrical fastener, but can be introduced into the bone opening with less force.
[0085] Figure 17 is a three-dimensional illustration of a distal end of a fastener 3, which is advantageous because it is introduced into the opening of the bone next to a graft, where the graft is positioned on the side of the fastener 3 which is in figure 17 on the left side of the fastener. The distal end of the fastener is tapered on this side of the graft to prevent the graft from being damaged by introducing the fastener next to the graft in the bone opening. The distal end of the fastener is tapered on the non-graft side (right side in figure 17) also, but less so, where the distal mouth of an axial passage hole through the fastener for accommodating a guidewire is located therein. As already mentioned in connection with figure 1, it is advantageous to position the through hole 37 and with it the guide wire in an eccentric way and as close as possible to the anchoring side of the fastener. The through hole 37 or a proximal section thereof may or may not serve as the internal cavity 4 as described for the fastener modalities according to, for example, figures 1 or 5.
[0086] Figures 18 to 22 illustrate ways in which, in a fixation according to the invention, the fastener 3 can be adapted to the graft 1 and the opening of the bone 2. The illustrated fasteners are all suitable for the fixation of an external graft and are partially based on the fastener principle as shown in figures 1 to 5 (fastener with internal cavity and at least one passage that connects the cavity to the circumferential surface of the fastener and anchoring element adapted to be positioned in the internal cavity), and partially on the principle of fastener as shown in figures 6 and 7 (fastener with at least one surface groove that runs in the axial direction and anchor element adapted to be advanced in the groove). The adaptation to the fastener principles according to figures 8 and 9 (anchoring element integrated in the fastener and forced anchoring material from the fastener by forcing the anchoring tool on the fastener) can be easily contemplated by a person skilled in the art who knows the present description without departing from the invention.
[0087] Figure 18 is a cross section through the fastener 3 and the graft 1, where the fastener 3 has a substantially round cross section smaller than the substantially circular cross section of the opening. The graft 1 that needs to be easily compressible is compacted in a narrow gap between the opening wall and the circumferential surface of the fastener 3 opposite the anchor 15 of the fastener in that wall. The exemplary dimensions for fastener 3, graft 1 and for the bone opening according to figure 18 are: opening diameter of 8 mm, fastener diameter of 7 mm, graft (for example, with sutured end) sized to pass easily through a 7 mm hole.
[0088] Figure 19 is a top view of a fastener 3 comprising a pressing sector at least partially concave 34 that forms a very shallow groove that extends axially to accommodate the graft. The anchoring sector of fastener 3 (opposite the pressing sector 34) is substantially circular and has the same radius as the bone opening 2 provided for the fastener. The fastener 3 may further comprise an axial through hole 37 adapted to be used to advance the fastener along a guidewire and / or to sew suture ends projecting from a sutured graft end portion through the fastener as discussed. above in connection with figures 4 and 17. The exemplary dimensions for the fastener 3 according to figure 19 and a graft and bone opening adapted between them are, for example: 8 mm opening diameter, sector radius of fastener anchor: 4 mm, fastener cross-sectional area and opening ratio: the same for the fastener in figure 18, the graft (for example, with a sutured end): dimensioned to easily pass through a 7 mm hole.
[0089] Figure 20 is a cross section through a fastener 3 and a graft 1 anchored in a bone opening 2. The fastener comprises a flattened pressing sector 34 as discussed in connection with figures 11 to 13 in which the graft 1 is compressed in the gap between that pressing sector 34 and the opening wall and in which the exact shape of the pressing sector 34 is adapted to the shape of the graft and to its compressibility.
[0090] In figure 21, the fastener 3 again has a substantially circular cross section that is considerably smaller than the also substantially circular cross section of the opening 2. The circumferential surface of the fastener 3 is pressed into the graft 1 which is not very deformable, while on both sides of the fastener 3 and possibly the graft 1 the bone opening 2 remains empty, unless means are provided in the fastener 3 for the liquefied anchoring material of the anchoring element to flow in that empty space in addition to the penetration of the wall opening bone.
[0091] In figure 22, the graft 1 is only slightly compressible and deformable and has, for example, a substantially circular cross section. A shallow groove (pressing sector 34) is provided in the fastener to accommodate the graft 1.
[0092] Figures 18 to 20 are especially theoretical, since they ignore the fact that the bone tissue around the bone opening is compressed by the forces that act on it when introducing the fastener and by the pressure fitting achieved through of this introduction so that the cross section of the bone opening is deformed, the degree of this deformation is dependent on the mechanical properties of the bone tissue.
[0093] Figure 23 illustrates a modality of the method according to the invention in which the opening 2 in the bone is pre-treated with a first portion of material which liquefies to be liquefied in situ by penetrating the trabecular structure of the opening wall. 2 and / or the cavities provided therein, and in the re-consolidation to form a type of composite layer 40 in which the liquefied material and bone tissue are connected together in a positive fit connection. Preferably, this pretreatment step is performed so that the cross section of the opening 2 remains substantially unmodified. Following the pre-treatment step, the fixation is performed exactly as described, for example, for the method as illustrated in figure 1 or 5, in which, in the anchoring step, a second portion of material that liquefies comprised by the anchoring element it is liquefied in situ and brought into contact with the first portion and between them to be soldered on it. The first and second portion of material that liquefies preferably comprises the same material that has thermoplastic properties, but can also comprise different such materials, which, however, need to be chosen to be able to form a welded connection 41 under the conditions of the anchoring. The adaptation of the method illustrated in figure 23 to another fastener begins as illustrated in figures 5 to 9 and is easily possible for a person skilled in the art and who is aware of the present presentation without departing from the scope of the invention.
[0094] The pretreatment step is, for example, performed in the same way as described for the method anchoring step according to figure 5 in which no fastener is positioned in the bone opening 2 and in the cross sections of the piece the foot and the anchor element are only very slightly smaller than the cross section of the bone opening. Additional exemplary methods for carrying out the pre-treatment step are described in publication No. WO 2009/141252 (Nexilis) and No. WO- 2010/045751, the presentation of both of which are included in this document for reference.
[0095] In order not to hinder the regeneration of bone tissue between the graft and the bone tissue of the bone opening wall, it may be advantageous to restrict the pretreatments described above to the anchorage side of the fastener. Such selective pretreatment of the wall of a bone opening is described in the above-cited publication No. WO-2010/045751 in connection with figure 8.
[0096] Figure 24 illustrates an exemplary embodiment of an expandable fastener that is suitable for an external graft fixation and an anchoring step as described for the method as illustrated in figures 1 to 5. The fastener comprises a slotted sleeve part 3a and a separating part 3b, which is, for example, thread-shaped. The glove part 3a is open at least proximally and comprises at least one axial slit 43 or a plurality of such slits which are arranged facing only one side of the glove part 3a (anchoring sector). The separating part 3b comprises an axial channel 44 and passages 45 that connect the axial channel 44 with the circumferential surface of the separating part 3b. The separating part 3b is adapted for the glove part 3a so that at the introduction of the separating part 3b in the glove part 3a the glove part is radially expanded and the slot (s) 43 are opened or enlarged. The opening provided in the bone is adapted for the glove part 3a so that it can be introduced into the opening after or in conjunction with the graft without the need for substantial force and so that the introduction of the separating part 3b into the glove part position causes sufficient expansion of the glove portion to achieve a fit by sufficient pressure. The pressure fitting is produced by positioning the glove part 3a between the bone wall of the opening and the graft with the slot (s) 43 facing the bone wall and then by threading the separating part 3b in the glove part 3a. The anchoring step is carried out, for example, as further described above in connection with figures 1 to 5 in which the liquefied material is liquefied in the axial channel 44 of the separating part 3b and flowed through passages 45 and slots 43 to contact the opening wall. As there are many slots 43 only in an anchoring sector of the glove part, the separator part 3b can comprise passages 45 all around, in which such passages eventually positioned in the pressing sector will remain closed by the glove part.
[0097] A person skilled in the art knows other modalities of expandable fasteners that can easily adapt to be suitable for the method according to the invention as illustrated in any of Figures 1 to 9 or 23.
[0098] Figure 25 illustrates an additional embodiment of the method according to the invention in which a graft 1 is attached to a bone opening 2 (external graft fixation in, for example, a bone tunnel). The left side of figure 25 shows the fastener 3 and the graft 1 pressed into the tunnel (as long as the direction of introduction from the top of the drawing) with the anchor 6 ready for the anchoring process (for example, securely fixed) rigid on the anchoring tool 13) and on the right side of the pressure fittings and the anchored fastener 3, that is, the final fixation. The fastener 3 used in this method comprises pressing again the surface portions and the anchoring surface portions, in which the different portions are arranged along the geometric axis of the fastener (not as in the previous figures, the sectors arranged around the circumference of fastener). In other words, the pressing surface portion extends completely around the fastener with the anchoring surface portion arranged proximally and possibly also distally in this. The fastener 3 can even have a proximal face but preferably has a slanted or uneven proximal face oriented to leave more of the bone wall free than that of the graft surface, where the selected portions of the proximal fastener face can be rough or otherwise properly structured. The anchor element 6 has a cross section that can be substantially the same as the cross section of the fastener 3 and is pushed in the space between the bone wall of the opening and the graft 1 towards the proximal fastener face and at the same time the anchor tool 13 is vibrated (or activated to transmit other energy to the anchor element). Among them, the material that liquefies is liquefied at least where it is in contact with the bone wall of the tunnel, but preferably also where in contact with the proximal face of fastener 3 and will therefore provide a proximal anchorage for fastener 3 in the bone wall. There will be no or almost no liquefaction of the material that liquefies where it is in contact with the graft, as the graft, contrary to the bone wall of the opening, is mostly soft and cannot provide energy directors to initiate such liquefaction.
[0099] To totally prevent friction and the transfer of thermal energy between the anchor element 6 and the graft 1 it may be advantageous to use in the method as shown in figure 25, an anchor element 6 and advantageously an anchor tool 13 of a cross section corresponding to only a part of the fastener cross section (for example, semicircular cross section for the anchor element and for the anchor tool and substantially circular fastener cross section) and for introducing the anchor element 6 into the opening of bone 2 in addition to the graft so that anchor element 6 and the graft 1 do not touch or at least do not press against each other.
[0100] If desired, the distal anchorage using the 6.1 anchor element is carried out in exactly the same way as the proximal anchorage.
[0101] As further detailed above, it is advantageous to advance the anchor in the same direction as the fastener 3 was forced into the tunnel to make sure that the anchoring process cannot in any way weaken the pressure fit achieved by forcing the fastener into the tunnel. Therefore, if distal anchoring is also desired, it will be advantageous to perform proximal anchoring first (anchor element 6) and then distal anchoring (anchor element 6.1).
[0102] Anchor elements 6 and 6.1 may, as described above, have a cross section substantially similar to fastener 3. However, this is not a necessity. The anchoring elements may, for example, additionally comprise edges with axially extending grooves or perforated structures to generate grooves or to pierce the walls of the opening while the anchoring element is advanced in the opening. Furthermore, the opening can be provided to be, for example, wider in the area in which the anchoring element is to be positioned than in the area in which the fastener is to be positioned.
[0103] Figure 26 illustrates fixation (fixation of external graft) of the end of a graft 1 in a blind opening with the aid of a fastener 3 comprising a proximal surface portion equipped to press and a distal surface portion equipped to anchor . The principle of the anchoring process is the same as illustrated in figures 1 to 4 with the difference that the fastener 3 is forced into the opening 2 preferably beyond the end of the graft to substantially come into contact with the back wall of the opening 2. The fastener 3 is then anchored laterally (anchors 15L) and / or distally (anchor 15D).
[0104] Figures 27 to 36 illustrate the internal graft fixations according to the invention. The principle of such internal graft fixation is the same as discussed above for external graft fixation, which means in particular that all the anchoring principles described above for external graft fixation are also applicable for internal graft fixation regardless of whether the they are specifically discussed below or not.
[0105] Figures 27 to 29 are cross sections through fasteners 3 applicable for the fixation of an internal graft in a bone opening that is a tunnel with a constant or non-constant cross section or is a blind hole. The fasteners according to figures 27 and 28 are applicable for grafts with two filaments (or four filaments separated into two pairs) and, therefore, comprise two pressing sectors 34, which are preferably located on the opposite sides of the fastener. A distal end of these fasteners is preferably equipped with a transverse groove to accommodate the graft at the end where the graft is, for example, folded. The fasteners according to figures 27 and 28 are anchored to the wall of a bone opening with the aid of an anchoring element that is introduced into an internal fastener cavity 4, the liquefied material is forced through the passage (s) ( s) 5 against the bone wall, in which, according to figure 27, the passage (s) 5 is arranged on the fastener side only (an anchoring sector only), according to figure 28 on the fastener sides opposites (two opposite anchoring sectors). The fastener according to figure 27 additionally comprises an axial through hole 37 adapted for the use of a guidewire and / or to sew a part of suture ends that protrude from suture graft ends through them, as discussed in connection with figure 4.
[0106] Figure 29 illustrates the same fastener principle as in figures 27 and 28, but it is applicable for a graft with four filaments, the four filaments are separated from each other and accommodated in four pressure sectors 34, which are arranged around of fastener 3, for example, in a regular pattern, mouths of passages 5 (anchoring sectors) which are arranged between the pressing sectors 34. Fastener 3 according to figure 29 is preferably used for a graft comprising two filaments folded and comprise at their distal ends preferably two transverse grooves arranged transversely each to accommodate one of the two folds of the filament.
[0107] Figures 30 to 33 are three-dimensional illustrations of fasteners that have a cross-section similar to that shown in figures 27 or 28. These fasteners differ from each other and from the fasteners illustrated in figures 27 and 28 in the design of the pressing sectors, which according to figure 30 comprise retention means in the form of transverse ribs 38, while according to figures 31 to 33 the fastener surface of the pressing sectors is substantially smooth. The shallow grooves constitute the pressing sectors 34 have a constant cross section along the fastener length for fasteners 3 of figures 30 and 31 and they have a decreasing depth and width towards the distal fastener end for the fastener of figure 32 and towards the end of the proximal fastener for the fastener of figure 33. Comparative experiments with the fasteners according to figures 30 to 33 show that the fastener according to figure 31 achieves the best fit by pressure.
[0108] Figures 34A and 34B illustrate a fastener set 3, anchor elements 6 and anchor tools 13 that are suitable for an internal graft fixation of a graft 1 comprising two filaments (or more than two separate filaments in a pair of filament groups) in a bone tunnel or blind opening, in particular fixation of a graft 1 that is bent over the fastener 3 and is forced into the tunnel or in the blind opening together with the fastener 3. The fixation achieved with the set as illustrated in figures 34A and 34B is based on the anchoring principle as illustrated in figures 6 or 7.
[0109] Figure 34A is an axial section through the complete assembly before fixation, figure 34B comprises two cross sections through fastener 3 and the graft 1 before fixation (above) and when the fixation is completed (below).
[0110] Fastener 3 according to figures 34A and 34B comprises two surface sectors equipped to press and the two surface sectors equipped to anchor, the different sectors that alternate around the circumference of the fastener. The pressing sectors 34 comprise shallow axial grooves that can be distally terminated in a distal transverse groove 52 in which the folded end of the graft is accommodated. The anchoring sectors are equipped like the anchoring sector of the fastener according to figures 6 or 7. The process of fastening to the fastener is substantially the same as that described in detail in connection with figures 6 and 7 and, therefore, is done reference to the corresponding part of the additional description above.
[0111] Figures 35A and 35B show an internal graft fixation to secure a double filament graft in a bone opening 2 (tunnel or blind opening), the fixation includes a proximal anchor similar to the proximal anchor shown in figure 25 for a external graft fixation. Figure 35A shows the process in an axially sectioned bone opening, figure 35B in a cross section through the anchoring element 6, in which both figures and the left side show the situation before the proximal anchoring is performed and the right side shows the finished fixation. Fastener 3 is press-fit and possibly laterally anchored to the circumferential wall of opening 2 (side anchor 15L) using any of the methods as illustrated in the previous figures. Then the proximal anchor element 6 which has a similar cross-section as the fastener 3 and can be shaped like a frustum is advanced into the opening 2 and pressed against the proximal face of the fastener using a suitably adapted anchoring tool 13, thus reaching the anchorage in the wall of the bone opening 2 proximal to the fastener 3 and possibly also in the face of the proximal fastener. As further discussed above in connection with figure 25, it is possible to make a similar anchoring (not shown) on the distal fastener side as soon as the proximal anchoring is done and prevents the weakening of the fitting by pressure with the force necessary to advance the distal anchoring through the use of a force that has a direction opposite to the direction of the force used to effect the press fit.
[0112] All fasteners illustrated in figures 1 to 34 are substantially cylindrical or slightly tapered and have substantially circular cross sections (without taking into account the grooves provided in the anchor sectors of the fastener surface to guide an anchor element and flat or concave shapes in the pressing sectors 34 provided to retain the soft tissue or graft filaments to be closed). Although this is the most preferred fastener form, since it is suitable to be inserted into a perforated opening that has a simple cylindrical shape, this is not a condition for the invention. All fasteners can have any cross section (eg oval, rectangular, polygonal) and fit into an opening of a corresponding cross section and they can either narrow continuously or in steps towards the distal end and fit into an opening that fits narrows continuously or in stages.
[0113] Figure 36 illustrates an example of fixing an internal graft (cross section through anchored fastener 3 and double filament graft 1) in a non-circular bone opening using a fastener 3 that has a non-circular cross section . In this, the bone opening is, for example, provided by puncture and has an elongated cross section and two graft filaments one is snapped into one end of the elongated cross section of the opening, the other filament at the other end, the fastener 3 is positioned and anchored (anchor 15) in the center of the elongated cross section. The cross section of the opening can be, for example, oval or rectangular (with rounded edges) and it can be curved as shown, or substantially straight, in particular it can be adapted to the anatomical characteristics of the attachment site. The fixation as shown in figure 36 is, for example, applicable for ACL surgery and allows very good reconstruction of the natural situation in relation to the area of occupation of the fixation, which allows adaptation to specific anatomical situations and cross the two filaments within the joint knee as in the natural joint. While according to the state of the art, the elongated occupation area can only be reached by fixing it in two separate holes, which require a minimum distance between them, fixing according to figure 36 can be performed in a considerably smaller space and it is therefore, for example, easily possible on the knee of a female patient.
[0114] Figures 37, 38A / B and 39A / B / C additionally illustrate fastener sets 3, anchor elements 6, anchor tool 13 and guide tool 14, where the guide tool 14 is suitable not only for guide the anchor tool 13 and possibly the anchor element 6 during the anchoring progress, but also to force the fastener into the bone opening preferably along the guide wire 60 to establish the graft pressure fit 1 and the anchor 3 in bone opening 2. The illustrated sets are suitable for fixing an external graft, but can easily be adapted for fixing an internal graft.
[0115] Figure 37 shows in an axial section a fastener 3 and a graft 1 snapped into a bone opening 2, where the fastener is suitable for an anchoring process as illustrated, for example, in figure 1 or in Figure 5. Also shown is a guide wire 60 and a guide tool 14, the guide wire 60 extends through the internal cavity 4 of the fastener, whose internal cavity 4 for this purpose comprises a distal end portion and mouth with the cross section adapted to the cross section of the guide wire 60. The internal cavity 4 is, for example, eccentrically positioned on the anchorage side of the fastener 3, which facilitates the introduction of the fastener into the bone opening along the guide wire 60. The guide tool 14 is shaped, for example, for manual manipulation and it comprises a distal end with a cross section adapted to the proximal cross section of the fastener 3, that is, the guide tool 14 comprises a through hole and axial adapted to continue the internal cavity 4 of the fastener in a proximal direction and it additionally comprises means for retaining the fastener preferably with a plug-in connection, for example, protuberance 62, which fits into a corresponding depression of the fastener 3. The assembly it further comprises an anchor element 6 which is pin-shaped and adapted to be inserted through the axial hole of the guide tool 14 into the internal cavity 4 of the fastener 3, and an anchor tool 13, the distal end portion of which is also adapted to be inserted through the axial hole of the guide tool 14. The anchor element and the anchor tool are not shown in figure 37.
[0116] Using the set according to figure 37, the fixation process comprises the following steps: introducing the graft 1 and the guide wire 60 into the bone opening; fix the fastener 3 to the guide tool 14; insert the proximal end of the guide wire 60 into the distal mouth of the inner cavity 4 and force the fastener 3 along the guide wire 60 into the opening, for example, using an impact tool that is applied to the proximal end of the tool of guide 14 or possibly to protect the proximal end of the guide wire 60, which is applied to a cannulated interface piece 63 positioned on the proximal face of the guide tool 14; remove interface piece 63 and guide wire 60; insert the anchor element 6 and the anchor tool 13 through the axial hole of the guide tool 14 towards the fastener; transmitting energy through the anchoring tool 13 to the anchoring element 6 for the anchoring process; stop the power transmission and remove the anchor tool 13 and the guide tool 14.
[0117] If fastener 3 comprises a separate axial hole for the guide wire, as shown, for example, in figures 19 and 27, the guide wire can be left in that hole during the anchoring step and can be removed together with the anchor tool and the guide tool. In such a case it is also possible for the internal cavity to be angled in relation to the through hole for the guidewire for an anchoring process similar to that illustrated in figure 14.
[0118] Figures 38A and 38B illustrate an additional assembly comprising a fastener 3, an anchor element 6, an anchor tool 13, and a guide tool 13 in an axial section (figure 38A) and a cross section (figure 38B), in which the anchor is snapped together with a graft 1 into a bone opening 2 and the assembly is ready for the anchoring step. The assembly is suitable for introducing fastener 3 into the bone opening 2 along a guide wire 60 and for anchoring fastener 3 using a method similar to that illustrated in figure 25. Fastener 3 comprises an anchoring element 6, which is attached to the proximal face of the fastener and has a cross section that forms part of the fastener cross section, for example, substantially semicircular cross section of anchor element 6 and substantially circular cross section of fastener 3. Fastener 3 and the anchoring element is preferably made as a piece and consists of the same thermoplastic material. In the transition from the anchor element 6 to the fastener 3, the anchor element comprises a reduced cross section, for example, through a groove 70 that crosses along the circumferential surface between the anchor element 6 and the fastener 3. The cross reduction section serves to concentrate the vibration energy transmitted by the anchoring tool to the anchoring element 6 so that liquefaction of the anchoring element begins in the region of the cross section reduction, that is, on the distal side of the anchoring element or on the face proximal fastener respectively. The fastener 3 and possibly the anchor element 6 additionally comprise an axial through hole to accommodate the guide wire 60.
[0119] The cross section of the anchor tool 13 is adapted to the cross section of the anchor element 6. The guide tool 14 comprises an axial hole for the guide wire 60 and a channel adapted for the cross section of the anchor element 6 and the anchoring tool 13. The guide tool 14 can be more easily manufactured if it comprises an inner part 14.1 with the hole for the guide wire 60 and with a groove adapted to the anchor element 6, and an outer part 14.2 which consists of a thin tube to which the inner part 14.1 is fixed and which closes the groove of the inner part to form a channel for the anchor element 6 and the distal end of the anchor tool 13, and which reaches the anchor side (left side in figure 38A) in the bone opening and to an axial position just proximal to the groove 70 and thus prevents the very proximal exit of the liquefied material from the anchoring element.
[0120] Fixing using a set according to figures 38A and 38B is performed in a similar way as described for the set according to figure 37, in which the guide wire 60 does not need to be removed before the step anchoring. Figure 38A and B shows the assembly ready for the anchoring step, with the guide wire still in position.
[0121] Figures 39A / B / C illustrate an additional set of fastener 3, anchor element 6, anchor tool 13 and guide tool 14, the set is shown in two side views (figure 39A and 39B rotated around the 90 ° geometric axis in relation to figure 39A) and in an axial sectional way (figure 39C). The set is shown assembled and ready for the anchoring step (guidewire removed, not shown). The assembly is suitable for anchoring using a method as illustrated in figure 1. The fastener 3 comprises an internal cavity 4 which is adapted for the anchoring element 6, is connected to the circumferential surface of the fastener by passages 5 and can comprise a narrow distal mouth for the guidewire. As it is mounted on the guide tool 14, the fastener comprises a proximal step profile 72 and a proximal internal thread.
[0122] The guide tool 14 comprises an inner part 14.1 and an outer part 14.2, in which the two parts are rotatable and axially displaceable in relation to each other. The internal part 14.1 of the guide tool 14 comprises the hole for the introduction of the anchor tool 13 and the anchor element 6 and, at its distal end, an external thread adapted to the internal thread of the anchor for a threaded connection 73 between the inner guide tool part 14.1 and the fastener 3. The outer guide tool part 14.2 comprises at its distal end a step profile 72 'that fits into the step profile 72 of the fastener 3. The proximal end of the tool portion internal guide. 14.1 comprises the handle knob 74 positioned from a proximal end portion shaped like a flashlight 75 from the external guide tool part 14.2 in which an operator can pick it up with his fingers to rotate the inner part 14.1 in relation to the outer part 14.2 of the tool guide number 14.
[0123] To mount the fastener 3 on the guide tool 14, the fastener 3 is pushed against the distal end of the guide tool 14, the step profiles of the fastener 3 and the distal end of the external guide tool part 14.1 integrate . Thus, the internal guide tool part 14.1 is rotated by its distal end which is threaded onto the fastener 3 which is prevented from rotating profiles in integrated steps 72 and 72 '. If a guidewire is used to insert the fastener 3 into the bone opening, the assembled assembly is then used as described for the assembly according to figure 37, in which, after removal of the guidewire, the anchoring element 6 and the anchoring tool 13 are inserted into the axial bore of the guide tool 14, where the anchoring tool 13 can already be coupled to a power supply (preferably, a vibration source). For such coupling, for example, the housing of an appropriately adapted ultrasonic device is threaded or fitted to the proximal end portion shaped like a flashlight from the external guide tool part 14.2, and thus plug-in coupling from the anchoring tool to the generator. vibration. A suitable ultrasonic device is described, for example, in patent application No. PCT / CH2010 / 000279, which has not yet been published and whose presentation is incorporated by reference in its entirety in this document.
[0124] In the specification above and in the attached figures, a plurality of modalities of methods, fasteners, and sets according to the invention are presented in which each figure shows a specific combination of resources. A person skilled in the art will easily be able to properly transfer the selected resources from those specific resources from one modality to another without the need for innovation and without departing from the scope of the invention.
[0125] Experimental results
[0126] External graft fixations according to the invention have been carried out and compared with similar fixations made with the aid of interference threads according to the state of the art and made with the aid of fasteners according to the invention but not are anchored in the opening (snap fit only). In addition, these fixations were compared with the published data for simple pressure snap pins as described in the publications initially cited by Mayr et al. Comparisons regarding fixation force, fixation stiffness, graft migration under low cycle fatigue conditions (1,000 cycles at a frequency of 0.5 Hz) and causes of final failure.
[0127] The fasteners used in the experiments were the fasteners as shown in figures 10 to 13. These fasteners as well as the interference threads used for the comparison had a diameter of 7 mm and a length of 30 mm and were made of titanium, steel stainless steel, PEEK or HA-PLA. The anchoring elements were made of PLDLLA. The grafts were grafted with four filaments made of bovine digital extensor of the forelimb by duplication through two dimensioned tendons, the final graft to easily pass through a 7.5 mm diameter hole. The bone openings in which the grafts were attached were tunnels with 8 mm in diameter drilled through the tibial bone bovine bone through the use of a pierced tibial cortex.
[0128] In general, the comparison showed that with the use of the fixation according to the invention it is possible to reach initial extraction forces that are up to 130% higher, initial failure forces that are up to 100% higher, fixation stiffness that is increased by 40% in graft migration comparable under low cycle fatigue conditions and, compared with interference threads, less graft damage.

权利要求:
Claims (12)
[0001]
1. Assembly to hold tissue or a prosthetic element in an opening (2) provided in a human or animal bone, the assembly characterized by the fact that it comprises: a fastener (3), in which the fastener (3) comprises a proximal face , a distal end, a fastener axis extending between the proximal face and the distal end and a circumferential surface extending around the fastener axis, where the fastener (3) further comprises at least a first portion of the surface circumferential and at least a second portion other than the first portion of the circumferential surface, wherein the first portion is equipped for anchoring comprising means for guiding a material that liquefies to the first portion or along the first portion, or comprising material that liquefies , the assembly further comprising: at least one anchor element (6) and an anchor tool (13), wherein the anchor element (6) comprises a material which are and liquefies and the anchoring tool (13) comprises a distal end adapted to the anchoring element (6) and is capable of transmitting energy to the anchoring element (6) and advancing the anchoring element (6) in relation to the fastener ( 3), and a guide tool (14), in which the guide tool (14) comprises a distal end adapted in cross section to the proximal cross section of the fastener (3) and which further comprises a passage channel adapted in cross section to a distal portion of the anchoring tool (13), where the distal end of the guide tool (14) is adapted to retain the fastener (3).
[0002]
2. Assembly, according to claim 1, characterized by the fact that the first and second portions of the circumferential fastener surface are arranged alternating the first and second sectors around the fastener axis.
[0003]
3. Assembly according to claim 2, characterized in that the means for guiding the liquefied material comprise at least one passage (5) for connecting an internal fastener cavity (4) which is opened on the face of the proximal fastener with the at least one first sector of the circumferential surface, comprises at least one channel (4/5) extending at an angle to an axis of the fastener from the face of the proximal fastener to the at least one first sector of the circumferential surface, or they comprise at least one groove (30) extending from the face of the proximal fastener towards the distal end of the fastener.
[0004]
4. Assembly according to claim 3, characterized by the fact that the internal cavity is distally closed or comprises a narrower distal portion and a distal mouth adapted to a guide wire (60).
[0005]
5. Assembly according to claim 3 or 4, characterized by the fact that an anchoring element (6) is positioned in the internal cavity (4), in at least one channel (4/5), or is integrated in the fastener (3) in a central region.
[0006]
6. Assembly according to any one of claims 2 to 5, characterized by the fact that, for an external graft fixation, the fastener comprises a first and a second sector.
[0007]
7. Assembly according to any one of claims 2 to 5, characterized by the fact that, for an external graft fixation, the fastener comprises a plurality of second sectors.
[0008]
8. Assembly according to any one of claims 1 to 7, characterized in that it further comprises a glove part (3a) and a separator part (3b), in which the separator part is dimensioned to expand the glove part when being introduced in it.
[0009]
9. Assembly according to any one of claims 1 to 8, characterized in that the at least one anchoring element (6) is adapted to axially extend grooves (30) on the circumferential surface of the fastener (3 ) to channels (4/5) that extend at an angle to the fastener axis from the proximal fastener face to the circumferential fastener surface, or to an internal fastener cavity (4) or is integrated into a central or peripheral fastener region.
[0010]
10. Assembly according to claim 1 or 9, characterized in that the anchoring element (6) has the shape of a pin or a tube.
[0011]
11. Assembly according to any one of claims 1 to 10, characterized in that it further comprises an ultrasonic device comprising a sonotrode that constitutes the anchoring tool (13).
[0012]
12. Assembly according to any one of claims 1 to 11, characterized in that the guide tool further comprises a through hole adapted to a guide wire (60).

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JP5767249B2|2015-08-19|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-02-18| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

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2020-06-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/01/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US29874610P| true| 2010-01-27|2010-01-27|

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US61/298,746|2010-01-27|

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PCT/CH2011/000005|WO2011091545A1|2010-01-27|2011-01-19|Method of fastening a tissue or a corresponding prosthetic element in an opening provided in a human or animal bone and fastener suitable for the method|

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