EP2558003A1 - Implant de fixation - Google Patents

Implant de fixation

Info

Publication number
EP2558003A1
EP2558003A1 EP11714915A EP11714915A EP2558003A1 EP 2558003 A1 EP2558003 A1 EP 2558003A1 EP 11714915 A EP11714915 A EP 11714915A EP 11714915 A EP11714915 A EP 11714915A EP 2558003 A1 EP2558003 A1 EP 2558003A1
Authority
EP
European Patent Office
Prior art keywords
fixation implant
implant according
expandable material
fixation
expandable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11714915A
Other languages
German (de)
English (en)
Inventor
Kurt Ruffieux
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synergy Biosurgical AG
Original Assignee
Synergy Biosurgical AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synergy Biosurgical AG filed Critical Synergy Biosurgical AG
Publication of EP2558003A1 publication Critical patent/EP2558003A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8645—Headless screws, e.g. ligament interference screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/042—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors plastically deformed during insertion
    • A61B2017/0422—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors plastically deformed during insertion by insertion of a separate member into the body of the anchor
    • A61B2017/0424—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors plastically deformed during insertion by insertion of a separate member into the body of the anchor the separate member staying in the anchor after placement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A61B2017/0429—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being expanded by a mechanical mechanism which also locks them in the expanded state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0438—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors slotted, i.e. having a longitudinal slot for enhancing their elasticity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A61B2017/0443—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws the shaft being resilient and having a coiled or helical shape in the released state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0817—Structure of the anchor
    • A61F2002/0823—Modular anchors comprising a plurality of separate parts
    • A61F2002/0835—Modular anchors comprising a plurality of separate parts with deformation of anchor parts, e.g. expansion of dowel by set screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0858—Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel

Definitions

  • the invention relates to a fixation implant for the clamping down of ligament grafts and the like. In or on bones according to the preamble of patent claim 1.
  • a ligament graft In a rupture of the cruciate ligament according to the current state of the art usually a ligament graft is used, the ends of which is fixed in each one located in the femur and in the tibia predrilled hole.
  • the fixation of the ligament graft is done in most cases by means of so-called interference screws.
  • Interference screws are usually tapered bone screws of different outer diameter, which are provided with an external thread. With such interference screws, the ligament graft, usually a tendon, is fixed in a predrilled bone bed. The fixation of the ligament graft is carried out by clamping between the bore wall in the bone and the interference screw. Interference screws are usually cannulated so that torque can be transmitted over the entire length of the screw when screwed into the bone. This is to prevent that too high a screwing resistance leads to breakage of the interference screw.
  • metallic interference screws those made of biocompatible plastics are now also known, which may also be absorbable.
  • the transplanted tendon When ligament grafts are fixed to repair cruciate ligament ruptures, the transplanted tendon may be injured by excessive squeezing. In addition, the transplanted tendon has the property to mechanically relax, causing the
  • a tendon is softer than a bone; However, from a certain degree of compression onward, it offers greater resistance than an interference screw screwed into a bone bed. This can lead to the surgeon exerting too much force when inserting the interference screw in order to overcome this increased resistance , As a result, not only the tendon but also the environment of the bone can be damaged.
  • the tendon is a viscoelastic tissue, which can maintain its volume over time while maintaining pressure. This leads to a reduction in volume of the graft to be fixed, with the result that the clamping force of the inserted fixation element is reduced and there is a loosening between fixation element and tendon.
  • Screw material often only with scar tissue and not with bone substance heals.
  • the combination of tendon damage, tendon volume reduction, bone dilation, and yet weak fixation can result in loosening between tendon and interference screw or the like fixation elements and unreliable graft fixation. This can ultimately even result in failure of the treatment.
  • a fixation element in the form of a bone dowel is described.
  • the bone dowel designed as a hollow body has, after its implantation over time on contact with body fluids, certain swelling properties which increase its external diameter.
  • the bone dowel is used to attach metal bone screws to bone tissue. Accordingly, a thread structure is provided inside the bone dowel.
  • the outer contour of the Bone dowel is provided with rounded ribs or a structure of spherical surfaces to protect the surrounding bone as possible.
  • 5,084,050 is hardly suitable since this is only insufficiently clamped because of the rounded outer contour of the bone dowel.
  • Another possible application for the fixation element described in US Pat. No. 5,084,050 is the fixing of ligamentous bone cylinders inside the bone dowel with subsequent ingrowth of bone. When swelling the optionally unilaterally closed hollow bone dowel, the central receiving bore for the metal screw or the bone cylinder is closed in the first place. Outwardly, however, hardly or only little pressure arises.
  • the bone screw can have a region that can swell when in contact with body fluids in order to achieve a firm connection between the bone fixation plate and the bone screw by increasing the outside diameter of this region.
  • a clamping fixation of a ligament graft in a bone bed between the outside of the bone screw and the wall of a hole in the bone is not mentioned in this document.
  • Suture anchors are cylindrical fixation elements that are anchored in bony or soft tissue to fix muscle tissue with a suture attached to the anchor.
  • the thread is usually passed through an axial bore in the suture anchor.
  • the suture anchors described there may also be made from a material which swells on contact with body fluids. Suture anchors are not suitable for clamping fixation of ligament grafts in bone deposits.
  • the object of the present invention is to provide a fixation element for attachment of ligament grafts and the like to or in bone, which initially fixes the graft and, despite the volume shrinkage of the graft, maintains the clamping pressure on the ligament graft.
  • the solution to these and other related problems is a fixation implant for clamping ligament grafts and the like or in bone, which has the features mentioned in claim 1. Further developments and advantageous and preferred embodiments of the invention are the subject of the dependent claims.
  • the fixation implant according to the invention serves, in particular, for clamping down ligament grafts and the like on or in bone tissue.
  • the body has an elongate body which has a settlement-side front end, at least partially consists of an expandable, after implantation on a surrounding bone substance an expansive pressure exerting material.
  • the body has an outer wall, which is at least partially provided with extending substantially transverse to the longitudinal profiles.
  • the body is provided with an engagement means for a Einbringinstrument or he has an opening in a central receptacle for a spreader.
  • the expandable material is arranged substantially over the entire longitudinal extension of the body. The areas provided with profilings can be pressurized by the expandable material in such a way that the outer diameter of the body increases.
  • the fixation implant Since the fixation implant has an expandable material which is arranged essentially over the entire longitudinal extent of its body, as uniform a pressure as possible is exerted on the ligament graft and on the bone structure surrounding the fixation implant. The pressure arises ab initio, i. immediately after insertion of the fixation implant, and remains upright, even if there is an expansion of the location hole in the bone.
  • the fixation implant according to the invention thus has a self-adjusting function.
  • the expandable material which may comprise, for example, an elastically compressible biocompatible plastic.
  • the expandable material comprises a material swellable on contact with body fluids. Since the fixation implant already exerts pressure on the ligament graft and the surrounding bone structure immediately after insertion into the receiving bore in the bone, and because of its self-adjusting function, the outer diameter of the fixation implant can be kept comparatively small. As a result, only a relatively small receiving bore must be created in the bone, which has an advantageous effect on the healing process. For example, the outer diameter of the fixation implant is about 5 mm to 10 mm.
  • fixation implant By one possible slim, open geometry of the fixation implant reduces the amount of material used; At the same time, the ingrowth of the ligament graft is also promoted, since bone and scar tissue can grow through the interstices. As a result of the ab initio expansion pressure, the largest possible contact area is achieved between the bone and the ligament graft, which promotes large-scale ingrowth.
  • the fixation implant according to the invention can also be arranged at the free end of the ligament graft (eg a tendon) in its interior. Thereafter, the thus loaded graft is pressed into the receiving bore in the bone.
  • the ligament graft Due to the expansion pressure and the self-adjustment effect of the fixation implant, the ligament graft is pressed on all sides against the bone wall, whereby a particularly large, ingrowth-promoting contact surface is achieved.
  • the adjustment of the fixation implant takes place in which the material used swells.
  • resorbable or non-absorbable polymers can be used. Investigations show, for example, that the addition of calcium phosphates to high molecular weight polylactides (200 ⁇ 00 g / mol) led to a constant volume increase during 40 weeks. The calcium phosphate leads to an osmotic difference which results in a water uptake. The resulting pressure in the fixation implant leads to its sources.
  • the expandable material preferably comprises an absorbable polymer having a molecular weight of ⁇ 10000 g / mol. It can be seen that below this molecular weight limit the strength of the polymer decreases significantly faster. This can be explained by an increased mobility of the molecules become. Investigations also show that polylactides with a L / D ratio of about 70/30 significantly increase in volume from about 20 weeks. In the case of polylactides from racemic D, L-lactide, the volume increase takes place after only 10 weeks. This corresponds approximately to the time of falling below a molecular weight of about 100 ⁇ 00 g / mol.
  • the fixation implant according to the invention consists of several layers of expandable materials which, on the one hand, enable the initial fixation and, on the other hand, allow the pressure to be maintained later by self-adjustment. This can be done, for example, by introducing pores into the fixation implant, via which the fluid intake and thus a swelling behavior can be controlled.
  • the biocompatible expandable material may also be made of nonabsorbable materials.
  • it may be a non-resorbent hydrogel or a salt-filled pad that absorbs and swells fluid through osmotic effects.
  • Combinations of expandable materials and non-expandable materials are also possible.
  • the outer portion of the fixation implant of comparatively hard shells with a grippy outer contour, while the core region of the fixation implant is made of an expandable, relatively soft material.
  • textile materials can be used.
  • the expandable material of the fixation implant is mechanically not particularly strong in connection with eg silicone or other soft components except for pressure.
  • Embodiment variants of the invention therefore provide that the expandable material is arranged in the fixation implant such that it can exert its pressure optimally.
  • this may be a zone extending within the length of the fixation implant in its interior.
  • an inserted swellable material is arranged in such a way that it does not penetrate to the outside, but body fluid can penetrate into the interior.
  • an outer shell enclosing the swellable material is made from a porous material, for example calcium phosphate, PEEK, polylactide, polyglycolide or the like.
  • the porosity can also be achieved by small holes, holes or capillaries. So body fluid can get inside the swellable material, while this itself remains trapped within the shell.
  • the source bare material surrounded by a mechanically resistant, liquid-permeable biocompatible membrane.
  • a further variant of the invention provides for forming the expandable material with different expansion behavior or setting a gradient with regard to the expansion.
  • a larger salt content eg 40-80 volume percent
  • the salt content at the surface of the expandable material is relatively small (eg. 10% by volume).
  • the fixation implant is designed in the manner of a well-known from the prior art interference screw with an outer diameter of about 5 mm to 10 mm.
  • the interference screws of the prior art has a solid body and is not cannulated.
  • a cover plate made of a rigid, non-expandable material is formed, in which an engagement means is formed with torque transmitting surfaces.
  • the interventional means is a known Torxx or Phillips recess whose depth is less than% of the axial length of the fixation implant.
  • the fixation implant which has the form of an interference screw, consists for example entirely of poly-D, L-lactide with an L-lactide to D-lactide ratio of 85/15.
  • This material has a molecular weight of ⁇ 100 ⁇ 00 g / mol and has a proportion of about 10% (w / w) of sodium phosphate.
  • the implant Immediately after insertion into the receiving bore in the bone, the implant begins to absorb body fluid and the swelling process begins.
  • the back pressure of the fixation graft and the bone environment counteract an increase in volume. If the fixation implant yields, the back pressure decreases and the fixation implant continues to swell. In the course of 1 to 2 years, the fixation implant completely degrades.
  • An alternative variant of the fixation implant according to the invention consists of two outer ribbed half-shells which are outwardly directed by an inner wedge. be pressed. A ligament graft is fixed by clamping between the fixation implant and the bone wall.
  • the half-shells consist of pure poly-D, L-lactide with a ratio of 70% L-lactide and 30% D-lactide with a molecular weight of about 200 ⁇ 00 g / mol.
  • the wedge consists of polylactide-co-glycolide with a molecular weight of ⁇ 100 ⁇ 00 g / mol, which is mixed with> 50% (w / w) tricalcium phosphate (TCP).
  • TCP tricalcium phosphate
  • the high content of TCP allows a quick diffusion of body fluid into the wedge and thus a rapid swelling of the same. This leads to a pushing apart of the half shells and thus to a self-adjustment effect of the fixation implant.
  • the wedge degrades within approx. 6 - 9 months, the half shells within approx. 2 years.
  • FIG. 1 shows a first embodiment of a fixation implant according to the invention in the form of an interference screw
  • FIGS. 2a and 2b show two views of a modified relative to Figure 1 second embodiment of the invention.
  • 3a and 3b show two views of a third embodiment of the invention in the form of an interference screw; 4a and 4b show two views of a fourth embodiment of the invention on
  • FIG. 5 is a comparison with the embodiment of FIG. 4 modified
  • Fig. 6 shows another embodiment of an interference screw
  • FIG. 8 shows a further embodiment of the fixation implant modified relative to the exemplary embodiment according to FIG. 7;
  • Fig. 9 is a trained for the fixation of multiple ligament grafts
  • FIG. 10 shows a further embodiment of the fixation implant
  • FIGS. 16 and 17 cross sections of two further variants of the embodiment
  • FIG. 19 is a perspective view of the fixation implant according to FIG. 18.
  • fixation implant 1 shows schematically a fixation implant which is designated overall by the reference numeral 1 and which has the outer shape of a conventional interference screw.
  • the fixation implant 1 has a solid body 2 made of a material expandable on contact with body fluids, in particular swellable material.
  • the outer wall 3 of the approximately torpedo-like body 2 is provided with thread-like profiles 4.
  • a cover plate 5 made of a non-expandable material is arranged, which is equipped with a receptacle 6 serving as an engagement means with torque transmission surfaces for an insertion instrument, for example a screwdriver bit or the like.
  • the cover plate 5 reduces the absorption of body fluid at the back of the implant, so that the implant expands as little as possible in the axial direction and so can not escape from the receiving bore in the bone.
  • the swellable material is provided for example with salt crystals.
  • the salt content in a central region of the swellable body 2 may be higher than in the near-surface regions.
  • the attachment of a ligament graft, in particular a tendon piece, in a bone bearing is effected by clamping between the outer wall 3 of the body 2 of the fixation implant inserted into a bone bore and the surrounding bone substance.
  • the exemplary embodiment of the fixation implant illustrated in FIG. 2 has a very similar interference screw design to the exemplary embodiment according to FIG.
  • the fixation implant provided overall with the reference numeral 1 again has a body 2 consisting of an expandable material. At its rear end a cover plate 5 is provided with a receptacle 6 for torque-transmitting Einbringinstrument.
  • the receptacle 6 protrudes into the body 2 of the fixation element 1 and has a covering layer 7 of a non-expandable material, which inwardly opposes the material of the body 2 that swells on contact with body fluid.
  • the outer wall 3 of the body 2, which is provided with thread-like profilings 4, consists of a non-expandable material, which ensures a harder surface of the fixation implant 1. As a result, the positive engagement with respect to the fixation implant and the surrounding bone material is improved.
  • the outer wall 3 of non-expandable material allows the ingress of body fluids to the swellable material of the body 2 and gives way under the inner swelling pressure, so that the fixation implant 1 can increase its outer diameter.
  • channels, slots or predetermined breaking points can also be arranged in the outer wall 3 (not shown).
  • the body 2 of the fixation implant consists of four shell segments 2a, 2b, 2c, 2d.
  • the outer walls 3 of the shell segments 2 a - 2 d are provided with profilings 4, which complement each other over the circumference of the fixation implant 1 like a thread.
  • the shell segments 2a-2d are separated from one another by diagonally extending slots 8a, 8b. Disposed in the slots 8a, 8b is a material 9 swellable on contact with bodily fluids.
  • the fixation implant 1 can be connected to a cover plate 5, in which a receptacle 6 for a torque-transmitting insertion instrument is arranged.
  • the exemplary embodiment of a fixation implant illustrated in FIGS. 4 a and 4 b is again designated overall by the reference numeral 1. Its outer shape largely corresponds to that of a torpedo-shaped interference screw.
  • the body 2 of the fixation implant 1 consists of a central structural framework of a non-expandable material. Furthermore, the body 2 has several circumferentially extending Shooting 10, which are formed open to the periphery. In the receptacles 10, a swellable in contact with bodily fluids material 9 is arranged in each case.
  • the receptacles may, for example, also extend in the axial direction.
  • the fixation implant has an engagement means in the form of a receptacle 6 for a torque-transmitting Einbringinstrument. The receptacle 6 can enforce the entire body 2 of the fixation implant 1.
  • the exemplary embodiment of the fixation implant 1 illustrated in FIG. 5 largely corresponds to that of FIGS. 4a and 4b.
  • the expandable material arranged in the circumferentially or axially extending receptacles 10 is covered towards the periphery by a non-expandable, harder layer 11.
  • the cover layer 11 is annular or spiral.
  • the cover layer 11 is designed such that it can be expanded by the swelling pressure of the expandable material 9 and can be pressed against the surrounding bone structure.
  • the outer surface of the cover layer 11 ideally has ribs or edges which ensure a better hold of the ligament graft, for example a tendon, in the bone.
  • the expandable material is compressed, thus ensuring an ab initio-acting expansion pressure on the ligament graft after insertion into the receiving bores.
  • FIG. 6 shows a further embodiment of a fixation implant 1, which is similar to the fixation implant shown in FIGS. 4a and 4b.
  • the body 2 of the fixation implant 1 is in turn formed by a central structural framework.
  • the swellable in contact with body fluids material 9 is arranged in channel-like receptacles in the body 2.
  • the body At its rear end, the body has a receptacle for a Einbringinstrument.
  • the fixation implant 1 designed as an interference screw is inserted into a bore B in a bone K and fixes a ligament graft, for example a tendon S, by clamping in the bone canal.
  • fixation does not take place by a mechanical change, in particular overall diameter increase of the fixation implant 1, but that the swelling material exits from one or more openings of the body 2.
  • the tendon S is fixed and also the interference screw in the bone canal B stabilized.
  • a further embodiment of a fixation implant shown schematically in FIG. 7 bears the reference number 21.
  • Its body 22 comprises two or more shell segments 22a, 22b which are separated from each other by longitudinal slots and fixed to each other in a manner not shown in detail, but fixed by one
  • the shell segments 22a, 22b are made of a self-expandable material. On the outer walls 23, the shell segments have profilings 24, which ensure better retention of a ligament graft and better anchoring of the fixation graft in a bone bore.
  • the shell segments may have openings which allow access of body fluid into the interior of the fixation implant.
  • the expansion pressure required for anchoring is applied by an expansion cone 26 which can be driven into a central bore 25 of the body 22 delimited by the shell segments 22a, 22b.
  • the central bore can be tapered conically in the insertion direction.
  • the expansion cone 26 consists partially or entirely of a material which can be expanded upon contact with body fluids.
  • the expansion cone 26 may be provided with a cover plate 27, which prevents ingress of body fluids from the rear side and opposes an expansion of the expansion cone out of the body 2.
  • the illustrated in Fig. 8 and again provided with the reference numeral 21 embodiment of the fixation implant 1 largely corresponds to the fixation implant of Fig. 7.
  • ribs 28 or the like are mounted, which form-fitting with correspondingly formed structurings 29 on the expansion cone 26 interact and prevent sliding back of the expansion cone 26.
  • a fixation implant shown in FIGS. 9a and 9b bears the reference numeral 31 as a whole.
  • Its body 32 has a plurality of shell segments 32a-32d, which are separated from one another by longitudinal slots 40.
  • axially extending recesses 41 are arranged, which conically taper from an insertion opening at the rear end of each shell segment 32a-32d in the direction of the front end of the body 32, preferably conically.
  • the recesses 41 are formed open towards the periphery of the body 32.
  • Each conical recess serves to receive a ligament graft, for example a tendon S.
  • the illustrated embodiment of the fixation implant 31 can therefore accommodate and hold up to four tendons S.
  • the expandable material 9 is arranged in the longitudinal slots 40 .
  • the expandable material is compressed and after insertion presses the shell segments 32a-32d apart.
  • the tendon material S is pressed against the wall of the bone canal B. If the bone canal B widens further, the material 9, which swells on contact with body fluids, ensures that the clamping pressure on the tendons S is maintained.
  • the outer surface of the shell segments adjacent to the tendon material may have increased roughness or be provided with ribs, spikes or edges to prevent slippage of the tendon material.
  • the bone channel B facing portions shell segments 32a - 32d may have additional anchoring aids such as edges, teeth or spikes so that they find better support in the bone canal B.
  • the exemplary embodiment of the fixation element illustrated in FIGS. 10a and 10b in turn bears the reference numeral 31 overall. It largely corresponds to the exemplary embodiment according to FIGS. 9a and 9b.
  • the shell segments 32a-32d which are separated from one another by longitudinal slots 40, can be expanded by a central swelling body 9 whose shape is designed specifically for the inner contour of the shell segments 32a-32d.
  • the central source body for example, a cross-shaped cross-section.
  • the central swelling body 9 has a wedge-shaped shape.
  • FIGS. 11-15 show cross sections of further configurations for fixation implants according to the invention, which are in each case provided with the reference numeral 51 in their entirety.
  • a body 52 which comprises a structural frame of a non-expandable material shown in gray in the figures, which is provided with radially expandable regions 53, which adjoin regions 54 of radially filled regions at least partially filled with expandable material, which are white in the figures are indicated.
  • the expandable material may be an elastic compressible material and / or a swellable material on contact with body fluids.
  • the non-expandable carrier material of the body 52 consists for example of polylactide (PLA).
  • the radially expandable portions 53 are formed like a shell segment and hinged axially on one side on the circumference of the body 52.
  • Each of the illustrated embodiments has at its rear end a central receptacle 56 for a Einbringinstrument.
  • the receptacle 56 may extend from the rearward end portion into the interior of the body 52.
  • On the outer wall of the body 52 can not Profiles shown in more detail, such as threads, edges, teeth, thorns etc. may be formed, so that a ligament graft can be better held, and the fixation implant finds a better anchoring in the bone canal.
  • 11 shows a fixation implant 51 having two wing-like shell segments 53 hinged on one side to the circumference.
  • the shell segments 53 adjoin circumferentially extending slots 54 in the body 52 which extend axially through the body 52. By an expansion pressure applied by the expanding material disposed in the slots 54, the wing-like shell segments 53 are pushed radially outward.
  • the fixation implant 51 shown in FIG. 12 largely corresponds to the exemplary embodiment according to FIG. 11.
  • four wing-like shell segments 53 are articulated on the central body 52, which are pressed radially outward by the expanding material arranged in the slots 54.
  • FIG. 13 shows a fixation implant 51 with three wing-like shell segments 53
  • FIG. 14 shows a fixation implant 51 with only one wing-like shell segment 53, which extends in an arc shape almost over the entire circumference of the body 52 and at an arcuate slot 54 adjacent, which is filled with the expandable material.
  • FIG. 15 shows an embodiment of a fixation implant 51 comprising two rows of concentrically arranged shell segments 53, 55, each separated by arcuate slots 54, 58 from each other and from the supporting structural framework of the body 52.
  • an expandable material is in turn arranged in the slots 54, 58 arranged in the body 52.
  • a mounting for an insertion instrument arranged in the body 52 bears the reference numeral 56.
  • the embodiment of the fixation implant shown in FIG. 16 is provided overall with the reference numeral 61, it has a body 62 which is composed of two half shells 62a, 62b which rest on not shown manner are interconnected.
  • the half-shells 62a, 62b are made of a non-expandable material, such as polylactide (PLA) and are separated by a diagonal longitudinal slot 64 which is filled with an expandable material.
  • the expandable material may be an elastically compressible material or a Contact with body fluids should be swellable material. Due to the expansion pressure of the expandable material, the two half shells 62a, 62b are pressed apart, whereby the outer diameter of the fixation implant 61 increases to the desired extent.
  • the recessed in the rear region of the body 62 receptacle 66 for a Einbringinstrument has according to the illustrated embodiment, the shape of an I.
  • the further exemplary embodiment of a fixation implant shown in cross section in FIG. 17 is provided with the reference numeral 71. It comprises a body 72 of a non-expandable material, for example of PLA, which is composed of three shell segments 72a, 72b, 72c, which are interconnected in a manner not shown.
  • the shell segments 72a, 72b, 72c are separated by three radially extending longitudinal slots 74 which are filled with expandable material.
  • the expansion pressure of the expanding material presses radially apart the three shell segments 72a, 72b, 72c as the outside diameter increases.
  • the body 72 has a receptacle 76 for an insertion instrument, which has the shape of a three-armed star with perpendicularly extending flags.
  • the three arms of the star-shaped receptacle 76 are arranged offset from the longitudinal slots 74 by about 60 °, so that they pass through the respective shell segment 72a, 72b, 72c approximately centrally.
  • FIG. 18 shows a view of the rearward end of a further exemplary embodiment of a fixation implant, which largely corresponds to the fixation implant illustrated with reference to the cross-sectional illustration of FIG. 13.
  • the illustrated implantation implant is again provided with the reference numeral 51 in its entirety.
  • this fixation implant 51 also has three wing-like shell segments 53, which are articulated radially movably on a body 52. Between the body 52 and the wing-like shell segments 53 each areas 54 are recessed, which are at least partially fillable with an expandable material. In the illustrated embodiment, for example, not the entire area 54 is backed with expandable material. Rather, grooves 59 are recessed in the areas 54, which receive the expandable material.
  • the expandable material may be an elastic compressible material and / or a swellable material on contact with body fluids.
  • the non-expandable carrier material of the body 52 consists for example of polylactide (PLA).
  • PPA polylactide
  • the fixation implant 51 has a central receptacle 56 for an insertion instrument.
  • the central receptacle 56 extends from the rear end portion into the interior of the body 52. Threaded portions are formed on the outer wall of the wing-like shell segments 53 for better retention of a ligament graft and for better fixation of the fixation implant in the bone canal.
  • FIG. 19 shows a perspective view of the fixation implant 51 according to FIG. 18 with a view of the front section in the intended use.
  • the three shell-like segments articulated axially on the body 52 are indicated at 53, respectively.
  • the area between the shell-like segments 53 and the body 52 is provided with the reference numeral 54.
  • the front portion of the fixation implant 51 is conically converging and has a kind of drill tip.
  • the formed on the outer sides of the shell-like segments 53 threaded portions are clearly visible.
  • the provided in the areas 54 between the body 52 and the shell-like segments 53 grooves for receiving the expandable material are indicated at 59.
  • the shell-like segments 53 are resiliently articulated to the body 52 of the fixation implant 51. As a result, they can be pressed together during the insertion of the fixation implant 51.
  • the expandable material for example, by a swellable on contact with body fluids material, the shell-like segments 53 are pressed with the threaded portions outwardly against the wall of the receiving material.
  • a swellable in contact with body fluid material is used. Examples of these are swellable hydrogels, in particular co-polymers based on methyl methacrylate and N-vinyl pyrrolidone, obtainable for example from Osmed GmbH, Hartheim, Germany.
  • FIGS. 1 to 19 have been described in the majority by the example of a material that swells on contact with body fluids. Instead of a swellable material, it is also possible to use an elastically compressible material or even a foamable material. Examples of these are polyurethane, polysiloxanes, polyolefins, soft polyvinyl chloride, synthetic rubber, thermoplastic elastomers and other polymers, as described in “Elastomers for Biomedical Applications", J Biomater Sei Polym Ed. 1998; 9 (6): 561-626 or in “Encyclopedia of Biomaterials and Biomedical Engineering ", eds. Wnek, G.
  • Nonabsorbable polymers may be any biocompatible polymers, such as e.g. Polyethylene, polypropylene, polyethylene terephthalate, polyether ketones, polyetheretherketones, polyvinyl chloride, polycarbonate, polyamides, polyimides, polystyrene, polyacrylamide, polybutadiene, polytetrafluoroethylene, polyurethane, polysiloxane elastomers, polyetheretherketone, polysulfone, polyetherimides, polyacetals, poly-paraphenylene, terephthalamide, silicones and Carbon or glass fiber reinforced composites.
  • Also suitable may be hydrogels of natural or synthetic origin which, however, do not dissolve upon absorption of water sources, e.g. Poly-2-hydroxyethyl methacrylate (PHEMA).
  • PHEMA Poly-2-hydroxyethyl methacrylate
  • Absorbable or partially resorbable polymers may be polyhydroxy esters, polyorthoesters, polyanhydride, polydioxanone, polyphosphazene, polyhydroxyalkanoate, polypropylene propoxide, polyesteramide, polyethylene fumarate, polylactide, polyglycolide, poly- ⁇ -caprolactone (PCL), polytrimethylene carbonate, polyphosphazene, polyphosphates, polyvinyl alcohol , Polyamic acid (b) or polynalic acid esters, poly-p-dioxanone and copolymers, modifications or mixtures thereof.
  • lactate / glycolide copolymers examples which may be mentioned are lactate / glycolide copolymers, lactate / tetramethylene glycolide copolymers, lactate / trimethylene carbonate copolymers, lactate / alpha-valerolactone copolymers, lactate / s-caprolactone copolymers, polydepsipeptides (glycine-DL-lactate copolymer or lactate / ethylene oxide copolymers, US Pat. or from the group of polyhydroxyalkanoates, eg PHB [polyhydroxybutyrate)], PHB / PHV (polyhydroxybutyrate / valerate).
  • mixtures or copolymers with vinyl polymers for example based on poly- ⁇ -maleic acid, aliphatic polyamides, aliphatic polyurethanes, for example polyurethanes of polyethylene glycol (PEG) diols or polycaprolactone diols and diisocyanates, polypeptides, for example synthetic polyamino acids and polyurethanes.
  • vinyl polymers for example based on poly- ⁇ -maleic acid
  • aliphatic polyamides for example polyurethanes of polyethylene glycol (PEG) diols or polycaprolactone diols and diisocyanates
  • PEG polyethylene glycol
  • polycaprolactone diols and diisocyanates polypeptides
  • synthetic polyamino acids and polyurethanes for example synthetic polyamino acids and polyurethanes.
  • a-amino acids for example poly- ⁇ -lysine or polybenzylglutamate, polyurethane-diol-glycosaminoglycan, polysaccharides, for example dextran derivatives, chitin and chitosan derivatives or hyaluronic acid esters, alginic acid nate, gelatin or cellulose derivatives, modified proteins, for example partially crosslinked collagen or fibrin, or modified carbohydrate polymers.
  • polysaccharides for example dextran derivatives, chitin and chitosan derivatives or hyaluronic acid esters
  • alginic acid nate gelatin or cellulose derivatives
  • modified proteins for example partially crosslinked collagen or fibrin, or modified carbohydrate polymers.
  • the polymers can be mixed with plasticizers, for.
  • plasticizers for.
  • monomers or oligomers of the same polymer of biocompatible plasticizer, e.g. Atecyltributyl citrate, citric acid, etc.
  • the superabsorbent is a copolymer of acrylic acid (propionic acid, C 3 H 4 O 2) and sodium acrylate (sodium salt of acrylic acid, NaC 3 H 3 O 2 ).
  • hydrophilic substances can usually be added to the polymers in the form of particles or nanoparticles. These particles produce an osmotic effect.
  • the possible substances are usually salts, e.g. Sodium chloride but also calcium phosphates, e.g. Monocalcium phosphate monohydrate, monocalcium phosphate anhydrate, dicalcium phosphate dihydrate, dicalcium phosphate anhydrate, tetracalcium phosphate, calcium orthophosphate, calcium pyrophosphate, ⁇ -tricalcium phosphate, ⁇ -tricalcium phosphate, apatites, e.g. Hydroxyapatite, calcium sulphates, sodium sulphates, sodium phosphates, etc.
  • the embodiments described above have in common that immediately after their insertion into a receiving bore in the bone, i. ab initio, enlarge their outer diameter and thereby exert a pressure on the surrounding bone substance.
  • the choice of materials is made such that an expansion pressure of 5 MPa is not exceeded.
  • the fixation implant is formed to have a low elastic compressibility.
  • the insertion of the fixation implant into the bone bore is thereby facilitated, and on the other hand an anchoring in the bone bore and a clamping fixation of a ligament graft are ensured ab initio independently of a swelling or a diameter enlargement by fluid uptake and storage.

Abstract

L'invention porte sur un implant de fixation, qui sert en particulier à la fixation par serrage de transplantations de ligaments et analogues à ou dans des tissus osseux. Cet implant présente un corps allongé, qui possède une extrémité avant, côté introduction, qui au moins par zones est constitué d'un matériau expansible, exerçant après l'implantation une pression d'expansion sur une substance osseuse environnante. Le corps possède une paroi extérieure, qui au moins par zones est pourvue de profilages courant pour l'essentiel perpendiculairement à l'extension longitudinale. Sur son extrémité arrière, le corps est pourvu de moyens de prise pour un instrument d'introduction, ou encore présente une ouverture aménagée dans un logement central, pour un écarteur. Le matériau expansible est pour l'essentiel disposé sur toute l'extension longitudinale du corps. Une pression peut être appliquée aux zones pourvues de profilages, par le matériau expansible, de façon à agrandir le diamètre extérieur du corps.
EP11714915A 2010-04-13 2011-04-11 Implant de fixation Withdrawn EP2558003A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH00529/10A CH702937A1 (de) 2010-04-13 2010-04-13 Fixationsimplantat.
PCT/CH2011/000075 WO2011127614A1 (fr) 2010-04-13 2011-04-11 Implant de fixation

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EP2558003A1 true EP2558003A1 (fr) 2013-02-20

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US (1) US20130103100A1 (fr)
EP (1) EP2558003A1 (fr)
JP (1) JP2013523353A (fr)
CN (1) CN102905629A (fr)
BR (1) BR112012026248A2 (fr)
CH (1) CH702937A1 (fr)
WO (1) WO2011127614A1 (fr)

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US10271943B2 (en) 2011-07-18 2019-04-30 Sportwelding Gmbh Method of fastening a soft tissue graft in an opening provided in a human or animal bone and fastener suitable for the method
CN104173095B (zh) * 2014-09-15 2016-05-04 广东泓志生物科技有限公司 一种骨科用挤压螺钉
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US10856966B2 (en) 2014-10-23 2020-12-08 Medos International Sarl Biceps tenodesis implants and delivery tools
US10076374B2 (en) 2014-10-23 2018-09-18 Medos International Sárl Biceps tenodesis delivery tools
US10751161B2 (en) 2014-10-23 2020-08-25 Medos International Sárl Biceps tenodesis anchor implants
US10729419B2 (en) 2014-10-23 2020-08-04 Medos International Sarl Biceps tenodesis implants and delivery tools
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US10231824B2 (en) 2016-04-08 2019-03-19 Medos International Sárl Tenodesis anchoring systems and tools
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BR112012026248A2 (pt) 2016-07-12
WO2011127614A1 (fr) 2011-10-20
CN102905629A (zh) 2013-01-30
US20130103100A1 (en) 2013-04-25
CH702937A1 (de) 2011-10-14
JP2013523353A (ja) 2013-06-17

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