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

• US 8,221,477 B2
• Filed: 06/08/2007
• Issued: 07/17/2012
• 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): Barrett, Thomas C.
• Assistant Examiner(s): ARAJ, MICHAEL J
• Application Number:
  US11/760,233
• Publication Number:
  US 20080045962A1
• Time in Patent Office: 1,866 Days
• Field of Search: 606/64, 606 92- 94, 606/300, 606/304, 606/323, 606 54- 60, 433172-176, 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. A method for creating a positive-fit connection capable of load-bearing to a tissue part in a human or animal body, the tissue part comprising first and second surfaces, the method comprising the steps of:

providing an implant comprising a central support with a proximal end and a distal base plate, the support and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material, which is biocompatible, has thermoplastic properties, and is liquefiable by mechanical oscillation, the second material being arranged around the central support,

providing a tissue opening reaching from the first surface to the second surface of the tissue part, the opening having a form which is adapted to the base plate and the second material,

positioning the implant with the base plate facing forward from the first surface through the opening so that the base plate is positioned beyond the second surface of the tissue part and fixing the positioned implant,

impinging a proximal face of the second material with mechanical oscillation and simultaneously pressing it against the base plate for a time sufficient for liquefying at least a part of the second material and for pressing it into surface unevennesses, cavities or pores of a wall of the tissue opening,

letting the second material pressed into said surface unevennesses, cavities or pores re-solidify and, in a re-solidified state, to constitute the positive-fit connection.

2. The method according to claim 1, wherein a cross section of the tissue opening is sufficiently smaller than a corresponding cross section of the second material, for achieving a friction-fit between the wall of the tissue opening and the implant.

3. The method according to claim 1, wherein the tissue part is a cortical bone.

4. The method according to claim 1, wherein the mechanical oscillation for impinging the second material has a predominantly same direction as the pressing of the implant against the base plate.

5. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises creating the unevennesses, cavities or pores in the wall of the tissue opening by hydraulic pressure.

6. The method according to claim 1, further comprising a step of mechanically creating the unevennessses, recesses or pores in the wall of the tissue opening.

7. The method according to claim 6, wherein the step of mechanically creating comprises roughening the wall of the tissue opening or creating a thread in the tissue opening.

8. The method according to claim 1, wherein the step of letting the second material re-solidify comprises stopping the impingement with mechanical oscillation, while still pressing the second material against the base plate.

9. The method according to claim 1, wherein the step of impinging and simultaneous pressing further comprises pressing the second material onto the second surface of the tissue part.

10. The method according to claim 1, wherein the mechanical oscillation has a frequency of between 2 and 200 kHz.

11. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises positioning a distal end of a resonator of an implantation device on the proximal face of the second material, wherein the resonator acts like a hammer thereon.

12. The method according to claim 1, wherein the base plate or the sleeve have a circular cross section and wherein the tissue opening is a bore in bone tissue.

13. The method according to claim 1, wherein the tissue part comprises living tissue.

14. The method according to claim 1, wherein said tissue part is a human or animal bone part, cartilage part, ligament part or tendon part.

15. The method according to claim 1, and further comprising a step of connecting another tissue part, a means for supporting or for replacing tissue, a suture, a cerclage wire or a therapeutic auxiliary device to the implant.

16. The method according to claim 15, wherein the means for supporting tissue is an external carrier beam.

17. The method according to claim 16, wherein the external carrier beam is connected with a plurality of implants.

18. The method according to claim 17, wherein the external carrier beam is positioned across a bone fracture or laceration.

19. The method according to claim 1, wherein the tissue part is a long bone and the opening reaches from an outside surface thereof into a marrow space thereof.

20. The method according to claim 1, wherein the step of positioning comprises positioning the implant through a tendon or ligament and through a bone part situated underneath the tendon or ligament.

21. The method according to claim 1, wherein the step of positioning and the step of impinging and simultaneous pressing comprise minimal invasive surgery.

22. A method for creating a positive-fit connection capable of load-bearing to a tissue part in a human or animal body, the tissue part comprising first and second surfaces, the method comprising the steps of:

providing an implant comprising a sleeve with an open proximal end, a base plate closing a distal end, and a perforated circumferential wall, the sleeve and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material being biocompatible and liquefiable by mechanical oscillation, the second material being arranged to be liquefied by the mechanical oscillation within the sleeve,

providing a tissue opening reaching from the first surface to the second surface of the tissue part, the tissue opening having a form adapted to a cross section of the sleeve,

positioning the implant with the distal end facing forward from the first surface through the opening so that the base plate is positioned beyond the second surface of the tissue part and fixing the positioned implant,

impinging a proximal surface of the second material with mechanical oscillation and simultaneously pressing it towards the base plate for a time sufficient for liquefying at least a part of the second material and for pressing it through the perforations into surface unevennesses, cavities or pores of a wall of the tissue opening,

letting the second material pressed into said surface unevennesses, cavities or pores to re-solidify and, in a re-solidified state, to constitute the positive-fit connection.

23. 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 comprising a central support with a proximal end and a distal base plate, the support and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material, which is biocompatible, has thermoplastic properties and is liquefiable by mechanical oscillation, the second material being arranged around the central support and a proximal face of the second material being equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable to be pressed into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection.

24. The implant according to claim 23, wherein the second material is arranged annularly or tubularly around the support.

25. The implant according to claim 23, wherein implant surfaces of the second material are equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

26. The implant according to claim 23, wherein implant surfaces of the second material comprise axially extending ribs which constitute humps or corners of an implant cross section.

27. The implant according to claim 23, wherein the second material is a non-resorbable or a resorbable polymer.

28. The implant according to claim 23, wherein the second material is a polyethylene (PE), a polymethyl metacrylate (PMME), a polycarbonate (PC), a polyamide, a polyester, a polyacrylate, 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.

29. The implant according to claim 28, wherein the polymer based on lactic acid and/or glycolic acid is PLA, PLLA, PGA, or PLGA.

30. The implant according to claim 28, wherein the foreign phases are fibers or whiskers.

31. The implant according to 23, wherein the second material further contains foreign phases or additional substances suitable for reinforcing, swelling or making porous the second material, or for promotion of healing or regeneration, or for furthering x-ray visibility.

32. The implant according to claim 31, wherein the additional substance is a growth factor, an antibiotic, an inflammation inhibitor or a buffer.

33. The implant according to claim 23, wherein the first material is a metal, a ceramic material, a glass, a polymer or a composite material.

34. The implant according to claim 23, wherein the first material comprises titanium, a cobalt-chrome alloy, polyetheraryl ketone, polyfluoro- and/or polychloroethylene, polyetherimide, polyethersulphone, polyvinylchloride, polyurethane, polysulphone, polyester, aluminium oxide, zirconium oxide, a silicate, a calcium phosphate ceramic or glass, or a carbon fiber reinforced high-temperature thermoplastic polymer.

35. The implant according to claim 23, wherein the proximal implant end 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, or a carrier beam.

36. 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 comprising a sleeve with an open proximal end, a base plate closing a distal end of the sleeve, and a perforated circumferential wall, the sleeve and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material being biocompatible and liquefiable by mechanical oscillation, the second material being arranged to be liquefied by the mechanical oscillation within the sleeve, a proximal face of the second material being accessible through the open proximal end of the sleeve and equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable of being pressed through the perforations into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection.

37. The implant according to claim 36, wherein the second material has thixotropic properties.

38. The implant according to claim 37, wherein the second material is a hydraulic or polymeric cement.

39. The implant according to claim 38, wherein the cement is a calcium phosphate cement, a calcium sulphate cement or a methacrylate cement.

40. The implant according to claim 36, wherein the sleeve consists of a porous sintered material.

41. The implant according to claim 40, wherein the porous sintered material is a metal or a ceramic material.

42. The implant according to claim 40, wherein an inside surface of the sleeve or surfaces of the second material in contact with the inside surface of the sleeve are equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

43. The implant according to claim 36, wherein the second material has thermoplastic properties.

44. A kit for creating positive-fit connections capable of load-bearing to a tissue part, the kit comprising:

a plurality of implants suitable for being implanted in a human or animal tissue part to form the positive-fit connection therewith, the implants comprising a central support with a proximal end and a distal base plate, the support and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material, which is biocompatible, has thermoplastic properties and is liquefiable by mechanical oscillation, the second material being arranged around the central support and a proximal face of the second material being equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable of being pressed into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection, and an implantation device comprising a generator, an oscillation element and a resonator, the generator being designed for exciting the oscillation element into mechanical oscillation, the resonator and the oscillation element being connected to form an oscillation unit, and a distal end of the resonator being adapted to the proximal face of the second material of the implant for transmission of the mechanical oscillations into the second material and for pressing the second material against the base plate.

45. A kit for creating positive-fit connections capable of load bearing to a tissue part, the kit comprising:

a plurality of implants suitable for being implanted in a human or animal tissue part to form the positive-fit connection therewith, the implants comprising a sleeve with an open proximal end, a base plate closing a distal end of the sleeve, and a perforated circumferential wall, the sleeve and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material being biocompatible and liquefiable by mechanical oscillation, the second material being arranged to be liquefied by the mechanical oscillation within the sleeve, a proximal face of the second material being accessible through the open proximal end of the sleeve and equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable of being pressed through the perforations into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection, and

an implantation device comprising a generator, an oscillation element and a resonator, the generator being designed for exciting the oscillation element into mechanical oscillation, the resonator and the oscillation element being connected to form an oscillation unit, and a distal end of the resonator being adapted to the proximal face of the second material of the implant for transmission of the mechanical oscillations into the second material and for pressing the second material against the base plate.

46. The kit according to claim 45, wherein the resonator is equipped for oscillating predominantly in a z-direction and for pressing the second material against the base plate in the same z-direction.

47. The kit according to claim 45, wherein the implantation device is equipped for setting various frequencies of the mechanical oscillations, various frequency patterns and/or various energy pulsations and wherein the kit further comprises setting instructions for different ones of the implants.

48. The kit according to claim 45, wherein the resonator of the implantation device comprises a proximal part and a distal part, the distal part being exchangeably fixed to the proximal part.

49. The kit according to claim 45, wherein the resonator of the implantation device or a distal part thereof is exchangeable and sterilizeable.

50. The kit according to claim 45, comprising a plurality of resonators equipped for being fixed to the oscillator, or a plurality of distal resonator parts equipped for being fixed to a proximal resonator part, the resonators or distal resonator parts being adapted to shapes and sizes of different implants of the kit.

51. The kit according to claim 45, wherein a distal face of the resonator or of a distal resonator part corresponds with the proximal face of the second material or with the open distal end of the sleeve.

52. The kit according to claim 45, and further comprising at least one drill adapted to a cross section of the implants.

53. The kit according to claim 45, wherein the oscillation element is a piezoelectric or magnetostrictive oscillator.

54. The kit according to claim 45, wherein the oscillation unit is driven to oscillate with a frequency between 2 and 200 kHz.

55. The kit according to claim 45, wherein the generator and the oscillation unit are designed for a distal resonator end to oscillate with an amplitude of between 1 and 100 μ

m.

56. An addition kit for creating positive-fit connections capable of load-bearing to a tissue part, the addition kit comprising:

one or more than one implant suitable for being implanted in a human or animal tissue part to form the positive-fit connection therewith, the implant comprising a central support with a proximal end and a distal base plate, the support and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material, which is biocompatible, has thermoplastic properties and is liquefiable by mechanical oscillation, the second material being arranged around the central support, and a proximal face of the second material being equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable of being pressed into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection, and

instructions for implanting the implants with the help of mechanical oscillation energy.

57. The addition kit according to claim 56, and further comprising at least one drill adapted to a cross section of the implants.

58. The addition kit according to claim 56, and further comprising a carrier beam, the supports and the carrier beam together forming an external fixation device to be mounted on a long bone.

59. The addition kit according to claim 56, and further comprising a stabilization or fixation plate suitable to be connected with the implant.

60. An addition kit for creating positive-fit connections capable of load-bearing to a tissue part, the addition kit comprising:

one or more than one implant suitable for being implanted in a human or animal tissue part to form the positive-fit connection therewith, the implant comprising a sleeve with an open proximal end, a base plate closing a distal end of the sleeve, and a perforated circumferential wall, the sleeve and the base plate consisting of a first material, which is not liquefiable under implantation conditions, and the implant further comprising a second material being biocompatible and liquefiable by mechanical oscillation, the second material being arranged to be liquefied by the mechanical oscillation within the sleeve, a proximal face of the second material being accessible through the open proximal end of the sleeve and equipped for transmitting mechanical oscillation into the second material and for simultaneously pressing the second material against the base plate for the second material to be at least partly liquefied, and the second material being capable of being pressed through the perforations into surface unevennesses, cavities or pores in an opening provided in the tissue part, and to re-solidify therein to constitute the positive-fit connection, and

instructions for implanting the implants with the help of mechanical oscillation energy.