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

• US 9,924,988 B2
• Filed: 03/20/2017
• Issued: 03/27/2018
• Est. Priority Date: 03/02/2001
• Status: Expired due to Term

• Current Assignee: Woodwelding AG
• Original Assignee: Woodwelding AG
• Inventors: Aeschlimann, Marcel, Torriani, Laurent, Lanci, Antonino, Mayer, Jrg
• Primary Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US15/463,052
• Publication Number:
  US 20170252082A1
• Time in Patent Office: 372 Days
• 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

A method for locating a material having thermoplastic properties in pores of bone tissue includes providing a pin having the material having thermoplastic properties and a core, wherein the material having thermoplastic properties is arranged on the circumferential surface of the core constituting an outer region of the pin. An opening is provided in the bone tissue, and the pin is positioned at least partly in the opening. The outer region of the pin is then impinged with mechanical vibration energy for a time sufficient for liquefying at least part of the material having thermoplastic properties, and, in a liquefied state, pressing it into the pores of the bone tissue surrounding the opening. The vibration energy is stopped for a time sufficient for re-solidification of the liquefied material, and then the core is removed.

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 support with a proximal end and a distal base plate, the support and the base plate not being liquefiable under implantation conditions, and the implant further comprising a second material, which is biocompatible, has thermoplastic properties, and is liquefiable by mechanical oscillation,

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 a cross section of the implant,

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 at least portions of the second material are positioned proximally of the base plate,

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 out of a region between the proximal face of the second material and the base plate, so that at least portions of the liquefied material are distally of the second surface of the tissue,

letting the second material to 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 support is a central support and wherein after the step of positioning the implant, the second material is arranged around the support.

4. The method according to claim 3, wherein the second material is chosen to have a tubular shape.

5. The method according to claim 3, wherein the support is a rod.

6. The method according to claim 1, wherein the tissue-part is a tubular bone part, and wherein during the step of impinging the proximal face with mechanical oscillation and simultaneously pressing, the portions of the second material are pressed into the marrow space.

7. The method according to claim 1, comprising the step of fixing the positioned implant after the step of positioning the implant.

8. The method according to claim 1, wherein during the step of impinging and simultaneously pressing, further portions of the second material are pressed into surface unevennesses, cavities or pores of a wall of the tissue opening.

9. The method according to claim 8 and further comprising a step of mechanically creating the unevennessses, cavities or pores in the wall of the tissue opening.

10. The method according to claim 9, wherein the step of mechanically creating comprises roughening the wall of the tissue opening or creating a thread in the tissue opening.

11. The method according to claim 1, wherein the support is a sleeve with an open, proximal end, the base plate closing a distal end of the sleeve, the sleeve comprising a perforated circumferential wall, and wherein during the step of impinging a proximal face of the second material with mechanical oscillation and simultaneously pressing it against the base plate, at the liquefied part of the second material is pressed through the perforations.

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

13. 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.

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

15. 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.

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

17. 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.

18. The method according to claim 1, wherein the base plate has a circular cross section and wherein the tissue opening is a bore in bone tissue.

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

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

21. 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.

22. The method according to claim 21, wherein the means for supporting tissue is an external carrier beam.

23. The method according to claim 22, wherein the external carrier beam is connected with a plurality of implants.

24. The method according to claim 23, wherein the external carrier beam is positioned across a bone fracture or laceration.

25. 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.

26. 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.

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

28. The method according to claim 1, wherein the second material is a non-resorbable polymer.

29. The method according to claim 1, wherein the second material is a resorbable polymer.

30. The method according to claim 1, 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.

31. The method according to claim 1, wherein the additional substance is a growth factor, an antibiotic, an inflammation inhibitor or a buffer.

32. The method according to claim 1, wherein the support plate and the base plate consist of a metal, a ceramic material, a glass, a polymer or a composite material.

33. A method for unicortically anchoring a fixation device to human or animal bone tissue, the method comprising the steps of:

providing the fixation device comprising a support with a proximal end and a distal base plate attached to a distal end of the support, the support and the base plate not being liquefiable under implantation conditions, and the fixation device further comprising a second material, which is biocompatible, has thermoplastic properties, and is liquefiable by mechanical oscillation,

providing a tissue opening reaching from the first surface to the second surface of a cortical bone opening into an interior space of the bone tissue but not through the cortical bone tissue on an opposite side, the opening having a form which is adapted to a cross section of the fixation device,

positioning the fixation device 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 cortical bone and at least portions of the second material are positioned proximally of the base plate,

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 out of a region between the proximal face of the second material and the base plate into the interior space,

letting the second material to re-solidify and, in a re-solidified state, to constitute a positive-fit connection of the fixation device to the bone tissue, the positive-fit connection constituting the unicortical anchoring of the fixation device, the anchoring in the bone tissue being secure against tilting.

34. The method according to claim 33, wherein the interior space is a marrow space.

35. The method according to claim 33, wherein the support is a central support and wherein after the step of positioning the implant, the second material is arranged around the support.

36. The method according to claim 33, wherein the support is a sleeve with an open, proximal end, the base plate closing a distal end of the sleeve, the sleeve comprising a perforated circumferential wall, and wherein during the step of impinging a proximal face of the second material with mechanical oscillation and simultaneously pressing it against the base plate, at the liquefied part of the second material is pressed through the perforations.