Implants for creating connections to tissue parts, in particular to skeletal parts, as well as device and method for implantation thereof

• US 8,323,323 B2
• Filed: 10/24/2007
• Issued: 12/04/2012
• Est. Priority Date: 03/02/2001
• Status: Active Grant

• Current Assignee: Woodwelding AG
• Original Assignee: Woodwelding AG
• Inventors: Aeschlimann, Marcel, Torriani, Laurent, Lanci, Antonino, Mayer, Jorg
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): Araj, Michael
• Application Number:
  US11/923,172
• Publication Number:
  US 20080275500A1
• Time in Patent Office: 1,868 Days
• Field of Search: 606/283, 606/284, 606/76, 606/77, 606/300, 433/172, 433/173, 433/201.1
• US Class Current: 606/300
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/688 for reattaching pieces of the skull
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 17/84 Fasteners therefor or fasteners being internal fixation devices
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/8655 with special features for locking in the bone
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61C 8/0016 polymeric material
• CPC Class Codes: A61C 8/0018 characterised by the shape
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/2875 : Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30749 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30767 : Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/36 : Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 : Femoral shafts
• CPC Class Codes: A61F 2/4601 : for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 : Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30065 : thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30067 : Coating or prosthesis-covering structure made of thermoplastic material
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/465 : using heating means
• CPC Class Codes: A61F 2002/4683 : by applying ultrasonic vibrations
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: B29C 65/00 : Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/08 : using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/48 : using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/54 : between pre-assembled parts
• CPC Class Codes: B29C 65/562 : using extra joining elements, i.e. which are not integral with the parts to be joined using plastic snap elements B29C65/58; using plastic rivets B29C65/601
• CPC Class Codes: B29C 65/601 : using extra riveting elements, i.e. the rivets being non-integral with the parts to be joined
• CPC Class Codes: B29C 65/603 : the rivets being pushed in blind holes
• CPC Class Codes: B29C 66/1122 : Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/126 : Tenon and mortise joints tenons and mortises for positioning purposes B29C65/7814
• CPC Class Codes: B29C 66/21 : said joint lines being formed by a single dot or dash or by several dots or dashes, i.e. spot joining or spot welding
• CPC Class Codes: B29C 66/30326 : in the form of porosity
• CPC Class Codes: B29C 66/5324 : said single elements being substantially annular, i.e. of finite length B29C66/5326 takes precedence
• CPC Class Codes: B29C 66/5346 : said single elements being substantially flat
• CPC Class Codes: B29C 66/542 : joining hollow covers or hollow bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/61 : Joining from or joining on the inside for making tubes by bending sheets and joining from the inside B29C53/387
• CPC Class Codes: B29C 66/652 : moving the welding tool around the fixed article
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/7212 : characterised by the composition of the fibres
• CPC Class Codes: B29C 66/727 : being porous, e.g. foam
• CPC Class Codes: B29C 66/73161 : Roughness or rugosity
• CPC Class Codes: B29C 66/73791 : biodegradable
• CPC Class Codes: B29C 66/7392 : characterised by the material of at least one of the parts being a thermoplastic
• CPC Class Codes: B29C 66/81423 : being concave
• CPC Class Codes: B29C 66/81429 : comprising a single tooth
• CPC Class Codes: B29C 66/81431 : comprising a single cavity, e.g. a groove
• CPC Class Codes: B29C 66/81433 : being toothed, i.e. comprising several teeth or pins comprising a single tooth B29C66/81429, or being patterned
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 66/836 : Moving relative to and tangentially to the parts to be joined, e.g. transversely to the displacement of the parts to be joined, e.g. using a X-Y table B29C66/65 takes precedence
• CPC Class Codes: B29C 66/9513 : characterised by specific vibration frequency values or ranges
• CPC Class Codes: B29C 66/9517 : characterised by specific vibration amplitude values or ranges
• CPC Class Codes: B29K 2005/00 : Use of polysaccharides or derivatives as moulding material
• CPC Class Codes: B29K 2023/04 : Polymers of ethylene
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2027/00 : Use of polyvinylhalogenides or derivatives thereof as moulding material
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2027/12 : containing fluorine
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/043 : PGA, i.e. polyglycolic acid or polyglycolide
• CPC Class Codes: B29K 2067/046 : PLA, i.e. polylactic acid or polylactide
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2071/00 : Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2079/085 : Thermoplastic polyimides, e.g. polyesterimides, PEI, i.e. polyetherimides, or polyamideimides; Derivatives thereof
• CPC Class Codes: B29K 2081/06 : PSU, i.e. polysulfones; PES, i.e. polyethersulfones or derivatives thereof
• CPC Class Codes: B29K 2307/04 : Carbon
• CPC Class Codes: B29K 2309/08 : Glass
• CPC Class Codes: Y10S 606/908 : Bioabsorbable material
• CPC Class Codes: Y10S 606/915 : Toolkit for installing or removing cortical plate
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

Implants (7) for forming a positive connection with human or animal parts include a material, such as thermoplastics and thixotropic materials, that can be liquefied by means of mechanical energy. The implants (7) are brought into contact with the tissue part, are subjected to the action of ultrasonic energy while being pressed against the tissue part. The liquefiable material liquefies and is pressed into openings or surface asperities of the tissue part so that, once solidified, the implant is positively joined thereto. The implantation involves the use of an implantation device that includes a generator (2), an oscillating element, and a resonator (6). The generator (2) causes the oscillating element to mechanically oscillate, and the element transmits the oscillations to the resonator (6). The resonator (6) is used to press the implant (7) against the tissue part to transmit oscillations to the implant (7).

Claims

1. An implant suitable for being implanted in a human or animal tissue part to form therewith a positive-fit connection capable of load-bearing, the implant being pin- or dowel-shaped and comprising a proximal face suitable for transmission of mechanical vibration into the implant and for simultaneously pressing the implant against the tissue part, and a contact surface to be brought into contact with the tissue part, and the implant further comprising a core carrying a coating of a first material, wherein the coating constitutes at least part of the contact surface and the first material comprises a biocompatible resorbable thermoplastic polymer, is liquefiable by the mechanical vibration and capable to be pressed, in a liquefied state, into surface unevennesses, cavities or pores of the tissue part and to re-solidify therein to constitute the positive-fit connection, and wherein the core comprises, at least underneath the coating, a surface suitable for osseointegration.

2. The implant according to claim 1, wherein the first material is a polymer based on lactic acid and/or glycolic acid, a polyhydroxyalkanoate (PHA), a polycaprolactone (PCL), a polysaccharide, a polydioxanone (PD), a polyanhydride or a corresponding copolymer.

3. The implant according to claim 2, wherein the first material further comprises reinforcing fibers or whiskers, in situ swelling or dissolving substances, in situ releasable substances suitable for promoting healing or regeneration, buffers, or admixtures for furthering x-ray visibility.

4. The implant according to claim 1, wherein implant surfaces of the first material are equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

5. The implant according to claim 1, wherein the core comprises a second material which is non-liquefiable at implantation conditions and which is one of titanium, aluminum oxide, zirconium oxide or a calcium phosphate ceramic or glass.

6. The implant according to claim 1, wherein a proximal implant end comprises a head, an artificial part replacing a further tissue part, a fixture for a further tissue part, or a therapeutic auxiliary device.

7. The implant according to claim 1, wherein, for being held by a distal end of a resonator, a proximal implant end is equipped with an inner thread, a resilient extension or a through bore.

8. The implant according to claim 1, wherein the implant is designed for replacing a further tissue part, or for fastening a further tissue part, a therapeutic auxiliary device, a suture, a cerclage wire, an artificial support or fixation element, a part of an artificial joint prosthesis, or an artificial tooth, bridge or dental prosthesis.

9. The implant according to claim 1, constituting a stem of a joint prosthesis, a joint prosthesis or a dental implant.

10. An implant suitable for being implanted in a human or animal tissue part to form therewith a positive-fit connection capable of load-bearing, the implant being pin- or dowel-shaped and comprising a proximal face suitable for transmission of mechanical vibration into the implant and for simultaneously pressing the implant against the tissue part, and a contact surface to be brought into contact with the tissue part, and the implant further comprising a core carrying a coating of a first material, wherein the coating constitutes at least part of the contact surface and the first material comprises a biocompatible resorbable thermoplastic polymer, and is liquefiable by the mechanical vibration and capable to be pressed, in a liquefied state, into surface unevennesses, cavities or pores of the tissue part and to re-solidify therein to constitute the positive-fit connection, and wherein the core comprises a surface preventing osseointegration.

11. The implant according to claim 10, wherein the first material is a polymer based on lactic acid and/or glycolic acid, a polyhydroxyalkanoate (PHA), a polycaprolactone (PCL), a polysaccharide, a polydioxanone (PD), a polyanhydride or a corresponding copolymer.

12. The implant according to claim 11, wherein the first material further comprises reinforcing fibers or whiskers, in situ swelling or dissolving substances, in situ releasable substances suitable for promoting healing or regeneration, buffers, or admixtures for furthering x-ray visibility.

13. The implant according to claim 10, wherein implant surfaces of the first material are equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

14. The implant according to claim 10, wherein the core comprises a second material which is non-liquefiable at implantation conditions and which is steel, a cobalt chrome alloy or a reinforced high-temperature thermoplast.

15. The implant according to claim 10, wherein a proximal implant end comprises a head, a fixture for a further tissue part, or a therapeutic auxiliary device.

16. The implant according to claim 10, wherein, for being held by a distal end of a resonator, a proximal implant end is equipped with an inner thread, a resilient extension or a through bore.

17. An implant suitable for being implanted in a human or animal tissue part to form therewith a positive-fit connection capable of load-bearing, the implant being pin- or dowel-shaped and comprising a proximal face suitable for transmission of mechanical vibration into the implant and for simultaneously pressing the implant against the tissue part and a contact surface to be brought into contact with the tissue part, the implant further comprising a first material, which comprises a biocompatible non-resorbable thermoplastic polymer and calcium phosphate admixed thereto, which is liquefiable by the mechanical vibration and is arranged to be liquefied in at least part of the contact surface, and which, in a liquid state, is capable to be pressed into surface unevennesses, cavities or pores of the tissue part and to re-solidify therein to constitute the positive-fit connection.

18. The implant according to claim 17, wherein the biocompatible, non-resorbable thermoplastic polymer is a polyethylene (PE), a polymethyl metacrylate (PMME), a polycarbonate (PC), a polyamide, a polyester, a polyacrylate or a corresponding copolymer.

19. The implant according to claim 18, wherein the thermoplastic polymer further comprises reinforcing fibers or whiskers, in situ swelling or dissolving substances, in situ releasable substances suitable for promoting healing or regeneration, buffers, or admixtures for furthering x-ray visibility.

20. The implant according to claim 17, wherein the implant further comprises a core with a proximal end, a distal end and a circumferential surface between the proximal end and the distal end and consisting of a second material which is not liquefiable at implantation conditions, and wherein the first material is arranged on the distal end of the core and/or on the circumferential surface of the core.

21. The implant according to claim 20, wherein the core is removable from the first material.

22. The implant according to claim 17, wherein implant surfaces of the first material are equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

23. The implant according to claim 17, wherein, for being held by a distal end of a resonator, a proximal implant end is equipped with a thread, a resilient extension or a through bore.

24. The implant according to claim 17, wherein the implant is designed for replacing a further tissue part, or for fastening a further tissue part, a therapeutic auxiliary device, a suture, a cerclage wire, an artificial support or fixation element, a part of a joint prosthesis, or an artificial tooth, bridge or tooth prosthesis.

25. The implant according to claim 17, constituting a stem of a joint prosthesis, a joint prosthesis or a dental implant.