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

• US 8,932,337 B2
• Filed: 11/02/2012
• Issued: 01/13/2015
• Est. Priority Date: 03/02/2001
• Status: Expired due to Fees

• 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 J
• Application Number:
  US13/667,098
• Publication Number:
  US 20130060265A1
• Time in Patent Office: 802 Days
• Field of Search: 606300-309, 606/313, 606/319, 606/321, 606/326, 606/327, 606/329, 606/331, 606/76, 606/77, 606/281, 606/298
• 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 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 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, an oscillating element, and a resonator. The generator causes the oscillating element to mechanically oscillate, and the element transmits the oscillations to the resonator. The resonator is used to press the implant against the tissue part to transmit oscillations to the implant.

Claims

1. A method for anchoring an implant in a tissue part of a human or animal body by creating a positive-fit connection capable of load-bearing between the implant and the tissue part, the method comprising the steps of:

providing the implant comprising a solid biocompatible material being reversibly liquefiable by energy,

positioning the implant in contact with the tissue part while the liquefiable material is solid,

impinging the positioned implant with energy for a time sufficient for liquefying at least a part of the liquefiable material, and exerting a pressure on the implant, thereby causing a hydrostatic pressure on liquefied material;

wherein the surface unevennesses, cavities or pores are at least one of naturally occurring and of created by the hydrostatic pressure of the liquefied material,

wherein the pressure is exerted until the hydrostatic pressure causes the liquefied material to be pressed into said unevennenesses, cavities or pores of the tissue part, and

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

2. The method according to claim 1, wherein the surface unevennesses, cavities or pores are naturally occurring.

3. The method according to claim 2, wherein the tissue part comprises bone tissue, and wherein the surface unevennesses, cavities or pores are bone related.

4. The method according to claim 3, wherein the bone tissue comprises cancellous bone, and wherein the surface unevenesses, cavities or pores are pores of cancellous bone.

5. The method according to claim 1, wherein the energy is mechanical energy.

6. The method according to claim 1, wherein the step of positioning the implant relative to the tissue part comprises positioning the implant on the tissue part in contact with the tissue part.

7. The method according to claim 1, wherein the step of exerting a pressure on the implant comprises pressing the implant against the tissue part.

8. The method according to claim 1, wherein the step of letting the liquefiable material to re-solidify comprises ceasing to impinge the implant with energy, while still exerting pressure on the implant.

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

10. The method according to claim 1, wherein the tissue part is a cartilage part, ligament part or tendon part.

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

12. The method according to claim 1, wherein the liquefiable material further comprises foreign phases or substances having further functions.

13. The method according to claim 1, wherein the liquefiable material is at least partly resorbable.

14. The method according to claim 1, wherein the implant consists of the liquefiable material.

15. The method according to claim 1, wherein the implant comprises a core of a second material not liquefiable under implantation conditions.

16. The method according to claim 15, wherein the first material is arranged on the distal end of the core and/or on the circumferential surface of the core.

17. The method according to claim 15, wherein the second material is a metal, a ceramic material, a glass, a polymer or a composite material.

18. The method according to claim 15, wherein the second material comprises at least one of 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, a carbon fiber reinforced high-temperature thermoplastic polymer.

19. The method according to claim 15, wherein the first material is resorbable and the core comprises a bioactive surface.

20. The method according to claim 15, wherein the core is a stem of a joint prosthesis.

21. The method according to claim 15, wherein the implant is a dental implant to be implanted in a jaw bone.

22. The method according to claim 15, wherein the liquefiable material covers the core in at least one region, with at least one other region of the core not being covered by the liquefiable material.

23. The method according to claim 1, wherein the implant comprises a sleeve of a non-liquefiable material wherein the liquefieable material is arranged in an inside of the sleeve wherein the sleeve comprises at least one opening for exit of the liquefied material and wherein in the step of impinging and simultaneously pressing, a tool is positioned against a proximal face of the liquefiable material.

24. The method according to claim 23, wherein the liquefiable material is resorbable and the sleeve at least partly has a bioactive surface.

25. The method according to claim 23, wherein the implant is a screw and the step of positioning comprises screwing the implant into bone tissue.

26. The method according to claim 25, wherein the implant is a tension screw and is used together with a trochanter plate for fixing a fractured femoral neck bone.

27. The method according to claim 1, wherein the implant is pin-or dowel-shaped.

28. The method according to claim 27, the implant comprising a proximal face, a contact surface to be brought into contact with the tissue part, and the liquefiable material, the first material constituting at least part of a contact surface, wherein the step of positioning the implant comprises bringing the contact surface into contact with the tissue part.

29. The method according to claim 1, comprising the step of creating an opening in the tissue part prior to the step of positioning the implant, wherein the step of positioning the implant comprises positioning the implant such that at least a portion of the implant protrudes into the opening.

30. The method according to claim 29, wherein the step of impinging and simultaneously exerting a pressure is carried out after the step of positioning.

31. The method according to claim 30, wherein the step of providing an opening in the tissue part comprises drilling the opening.

32. The method according to claim 29, wherein the tissue part is a bone part with an outer layer of cortical bone and inner cancellous bone and wherein the step of providing an opening in the tissue part comprises opening the cortical layer only.

33. The method according to claim 29, wherein a cross section of the opening provided in the tissue part is sufficiently smaller than a corresponding cross section of the implant, for achieving a friction-fit between a wall of the opening and the implant.

34. The method according to claim 1, wherein the implant is designed to be suitable as an anchoring means for an artificial support or fixation element, for a prosthesis of a joint ball or socket, for an artificial tooth, bridge or tooth prosthesis, for a suture thread, for a cerclage wire or for a therapeutic auxiliary device.

35. The method according to claim 1, wherein the step of impinging and simultaneously exerting a pressure comprises pressing with a force of 0.5 to 5 N per mm2 of implant cross section.

36. The method according to claim 1, wherein the step of impinging and simultaneous pressing comprises driving the implant into the tissue part to form an opening therein.

37. The method method according to claim 1, wherein the first material is a non-resorbable or a resorbable polymer.

38. The method according to claim 37, 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.

39. The method according to claim 38, wherein the polymer based on lactic acid and/or glycolic acid is PLA, PLLA, PGA, or PLGA.

40. The method according to claim 1, comprising the further step of controlling the temperature of at least one of surrounding tissue and of surrounding material.

41. The method according to claim 40, wherein the step of controlling comprises actively controlling the energy supplied during the step of impinging.

42. The method according to claim 41, further comprising controlling energy removed during the step of impinging.

43. The method according to claim 40, further comprising measuring a temperature by at least one sensor.

44. The method according to claim 40, further comprising arranging heat conducting elements for dissipating excess energy.

45. The method according to claim 1, wherein the steps of impinging and of exerting a pressure are carried out simultaneously.

46. The method according to claim 1, wherein the liquefiable material is present as a one-piece macroscopic bulk material.

47. The method according to claim 1, wherein the implant is a contiguous solid body or comprises a sleeve and a piece of the liquefiable material.

48. A method for anchoring an implant in a tissue part of bone tissue of a human or animal body by creating a positive-fit connection between the implant and the bone tissue, the method comprising the steps of:

providing the implant comprising a solid biocompatible material being reversibly liquefiable by energy,

positioning the implant relative to the bone tissue while the liquefiable material is solid,

impinging the positioned implant with energy for a time sufficient for liquefying at least a part of the liquefiable material, and exerting a pressure on the implant, thereby causing a hydrostatic pressure on liquefied material;

wherein the surface unevennesses, cavities or pores are at least one of naturally occurring and of created by the hydrostatic pressure of the liquefied material;

wherein the pressure is exerted until the hydrostatic pressure causes the liquefied material to be pressed into said unevennenesses, cavities or pores of the tissue part, and

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

49. The method according to claim 48, wherein the tissue part comprises living tissue.

50. A method for anchoring an implant in a tissue part of a human or animal body by creating a positive-fit connection capable of load-bearing between the implant and the tissue part, the method comprising the steps of:

providing the implant comprising a solid biocompatible material being reversibly liquefiable by energy,

positioning the implant relative to the tissue part so that the liquefiable material is in a vicinity of surface unevennesses, cavities or pores of the tissue part, while the liquefiable material is solid,

impinging the positioned implant with energy to selectively liquefy the liquefiable material at the points where it is in a vicinity to the surface unevennesses, cavities or pores, and exerting a pressure on the implant for causing a hydrostatic pressure on liquefied material;

wherein the pressure is exerted until the hydrostatic pressure causes the liquefied material to be pressed into said unevennenesses, cavities or pores of the tissue part, and

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

51. The method according to claim 50, wherein the step of positioning the implant comprises positioning the implant in an opening of the tissue part.

52. A method for fastening a device to a tissue part of a human or animal body, the method comprising the steps of:

providing the device, the device having a surface portion comprising a surface structure suitable for a positive fit;

providing an implant comprising a solid biocompatible material being reversibly liquefiable by energy;

anchoring the implant in the tissue part;

while the device is in contact with the implant, impinging the implant with energy for a time sufficient for liquefying at least a part of the liquefiable material, and exerting a pressure on the implant, thereby causing a hydrostatic pressure on liquefied material;

wherein the pressure is exerted until the hydrostatic pressure causes the liquefied material to be pressed into said unevennenesses, cavities or pores of the tissue part, and

letting the liquefiable material pressed into said surface structure to re-solidify and, in a re-solidified state to constitute a positive-fit connection.

53. The method according to claim 52, wherein the step of anchoring comprises pressing liquefied material into surface unevennesses, cavities or pores of the tissue part;

wherein the surface unevennesses, cavities or pores are at least one of naturally occurring and of created by hydrostatic pressure of the liquefied material, the hydrostatic pressure generated by the pressure exerted on the implant.

54. The method according to claim 53, wherein the step of pressing liquefied material into surface unevennesses, cavities or pores is carried out simultaneously with the step of pressing liquefied material into the surface structure of the surface portion.

55. The method according to claim 52, wherein the device is chosen to be a fixation plate.

56. The method according to claim 52, wherein the device is chosen to be of a material that is not liquefable under implantation conditions.

57. The method according to claim 56, wherein the device is metallic.

58. The method according to claim 52, wherein said surface structure is chosen to be a thread.

59. The method according to claim 52, wherein the step of anchoring the implant is carried out after the step of letting the liquefiable material pressed into said surface structure re-solidify.

60. The method according to claim 52, wherein the step of anchoring the implant is carried out after bringing the device in contact with the implant.

61. The method according to claim 52, wherein in the step of impinging the implant with energy and exerting a pressure, the energy and pressure are coupled into the implant via the device.