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

• US 8,221,475 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:
  US11/760,224
• Publication Number:
  US 20080045961A1
• Time in Patent Office: 1,866 Days
• Field of Search: 606/70, 606/281, 606284-286, 606/288, 606/298, 606/76, 606/77
• US Class Current: 606/281
• 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 or resorptive
• 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 method comprising the steps of:

providing a plate- or film-shaped implant or implant part comprising a first surface to be in contact with the tissue part and a second surface opposite the first surface and further comprising a first material which is biocompatible, has thermoplastic properties, is liquefiable by mechanical oscillation, and is arranged to be liquefied by the mechanical oscillation at the first surface,

positioning the implant on the tissue part with the first surface in contact therewith, impinging the second surface of the positioned implant with mechanical oscillation and simultaneously pressing the implant against the tissue part for a time sufficient for liquefying at least a part of the first material and for pressing it into surface unevennesses, cavities or pores of the implant part,

letting the first material pressed into said surface unevennesses, cavities or pores to re-solidify to constitute the positive-fit connection.

2. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises creating the surface unevennesses, cavities or pores by hydraulic pressure.

3. The method according to claim 1, and further comprising a step of mechanically creating the surface unevennesses, cavities or pores.

4. The method according to claim 3, wherein the step of mechanically creating comprises creating recesses or grooves in a tissue part surface or roughening the tissue part surface.

5. The method according to claim 1, wherein the step of letting the first material re-solidify comprises stopping the impingement with mechanical oscillation, while still pressing the implant against the tissue part.

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

7. The method according to claim 1, wherein the step of impinging and simultaneous pressing is limited to a plurality of separate locations of the surfaces of the implant.

8. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises contacting the second implant surface with a resonator of an implantation device, wherein the resonator acts like a hammer on the implant.

9. The method according to claim 8, wherein a distal end of the resonator oscillates predominantly in a z-direction and the implant is pressed against the tissue part in the same z-direction.

10. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises contacting the second surface of the implant with a transition element which is actively coupled to a resonator of an implantation device, wherein a distal end of the transition element oscillates predominantly perpendicularly to the direction in which the implant is pressed against the tissue surface.

11. The method according to claim 1, wherein the implant comprises a foil of the first material and a plate of a second material, which is not liquefiable under implantation conditions, wherein the step of positioning comprises positioning the foil on the tissue part and then positioning the plate on the foil and wherein the step of impinging and simultaneous pressing comprises contacting the plate with a resonator of an implantation device or with a transition element actively coupled to the resonator.

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

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

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

15. The method according to claim 1, wherein the implant is positioned over a bone fracture or across a gap between two bone plates or between a bone plate and an artificial plate replacing a bone plate and wherein the step of impinging and simultaneously pressing is carried out on both sides of the fracture or gap.

16. The method according to claim 15, wherein the implant is positioned in a head region of a patient for repair or reconstruction purposes.

17. The method according to claim 15, wherein the implant is positioned across a gap between two calvaria parts or between a calvaria part and an artificial cover plate replacing a calvaria part.

18. The method according to claim 15, wherein the implant is positioned over at least two vertebral bodies.

19. The method according to claim 18, wherein the implant is elastically deformable.

20. The method according to claim 1, wherein the implant is a joint socket prosthesis.

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. 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 plate- or film-shaped and comprising a first surface to be in contact with the tissue part, a second surface opposite the first surface, and a first material, which is biocompatible, has thermoplastic properties, is liquefiable by mechanical oscillation, and is arranged to be liquefied by the mechanical oscillation at the first surface, the second surface being equipped for transmitting mechanical oscillation into the implant and for simultaneously pressing the implant against the tissue part for the first material to be at least partly liquefied, and the first material being capable of being pressed into surface unevennesses, cavities or pores of the tissue part and to re-solidify therein to constitute the positive-fit connection.

23. The implant according to claim 22, wherein the first material is a non-resorbable or a resorbable polymer.

24. The implant according to claim 22, wherein the first 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.

25. The implant according to claim 24, wherein the polymer based on lactic acid and/or glycolic acid is PLA, PLLA, PGA, or PLGA.

26. The implant according to claim 22, wherein the first material further contains foreign phases or additional substances suitable for reinforcing, swelling or making porous the first material, or for promotion of healing or regeneration, or for furthering x-ray visibility.

27. The implant according to claim 26, wherein the additional substance is a growth factor, an antibiotic, an inflammation inhibitor or a buffer.

28. The implant according to claim 26, wherein the foreign phases are fibers or whiskers.

29. The implant according to claim 22, wherein the first surface of the implant is equipped with energy directors in the form of projecting pyramids, cones, hemispheres or ribs.

30. The implant according to claim 22, being a flexible foil, textile web, or tape.

31. The implant according to claim 30, wherein the implant consists fully of the first material.

32. The implant according to claim 30, wherein the implant further comprises a reinforcing structure.

33. The implant according to claim 32, wherein the reinforcing structure is a fiber mat.

34. The implant according to claim 22, wherein the implant comprises a plate constituting the second surface, the plate comprising a second material, which is not liquefiable under implantation conditions.

35. The implant according to claim 34, wherein the implant further comprises a foil or coating of the first material attached to a plate surface facing away from the second implant surface.

36. The implant according to claim 34, wherein a plate surface facing away from the second implant surface comprises a structure suitable for a positive-fit connection and wherein the implant further comprises a foil of the first material which is attached or attachable to the structure.

37. The implant according to claim 34, wherein the second material of the plate is a metal, a ceramic material, a glass, a polymer or a composite material.

38. The implant according to claim 34, wherein the plate 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.

39. The implant according to claim 34, wherein the first material is resorbable and the plate comprises a bioactive surface facing towards the first implant surface.

40. The implant according to claim 34, 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, or an artificial joint socket to bone tissue.

41. 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 implant being plate- or film-shaped and comprising a first surface to be in contact with the tissue part, a second surface opposite the first surface, and a first material, which is biocompatible, has thermoplastic properties, is liquefiable by mechanical oscillation, and is arranged to be liquefied by the mechanical oscillation at the first surface, the second surface being equipped for transmitting mechanical oscillation into the implant and for simultaneously pressing the implant against the tissue part for the first material to be at least partly liquefied, and the first material being capable of being pressed into surface unevennesses, cavities or pores of 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 the resonator being designed for a distal resonator end to predominantly oscillate in a z-direction and to act on the implant like a hammer and to simultaneously press the implant against the tissue part in the same z-direction, or the resonator comprising a transition element designed for a distal end thereof to oscillate predominantly perpendicularly to the z-direction and to press the implant against the tissue part in the z-direction.

42. The kit according to claim 41, 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.

43. The kit according to claim 41, wherein the resonator comprises a proximal and a distal part, the distal part being exchangeably fixed to the proximal part.

44. The kit according to claim 41, wherein the resonator of the implantation device or a distal part thereof or the transition element is exchangeable and sterilizeable.

45. The kit according to claim 41, 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.

46. The kit according to claim 41, wherein the oscillation element of the implantation device is a piezoelectric or magnetostrictive oscillator.

47. The kit according to claim 41, wherein the oscillation unit of the implantation device is driven to oscillate with a frequency between 2 and 200 kHz.

48. The kit according to claim 41, wherein the generator and the oscillation unit of the implantation device are designed for a distal end of the resonator or of the transition element to oscillate with an amplitude of between 1 and 100 μ

m.

49. 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 being plate- or film-shaped and comprising a first surface to be in contact with the tissue part, a second surface opposite the first surface, and a first material, which is biocompatible, has thermoplastic properties, is liquefiable by mechanical oscillation, and is arranged to be liquefied by the mechanical oscillation at the first surface, the second surface being equipped for transmitting mechanical oscillation into the implant and for simultaneously pressing the implant against the tissue part for the first material to be at least partly liquefied, and the first material being 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, and

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