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

• US 9,615,872 B2
• Filed: 11/30/2015
• Issued: 04/11/2017
• 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:
  US14/953,869
• Publication Number:
  US 20160074083A1
• Time in Patent Office: 498 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, 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

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. An implantation kit for fixing or stabilizing bone tissue, comprising:

a fixation or stabilization plate, the plate comprising a bone side surface, a surface opposite the bone side surface and a plurality of through openings;

for each one of the through openings, a fastener implant, the fastener implants being generally pin-like and comprising;

a distal shaft and a proximal head, and

at least at a distal end of the shaft, a thermoplastic material liquefiable by mechanical oscillation,

wherein the shaft comprises energy directors for targeted liquefaction by concentration of oscillation energy;

wherein the shaft is capable of being advanced through the respective through opening of the plate, and wherein the fastener implants are equipped for being anchored by pressing the implant against the bone tissue with the shaft projecting through the through opening while impinging the implant with mechanical oscillation and without rotating the fastening implant until at least a part of the liquefiable material is liquefied and is pressed into structures of the bone tissue, and then letting the liquefiable material resolidify;

and wherein the head of the fastener implant is configured to secure the plate against the bone tissue when the shaft reaches through the opening and is anchored in the bone tissue.

2. The kit according to claim 1, wherein the fastener implants consist of the thermoplastic material.

3. The kit according to claim 1, wherein the energy directors comprise at least one of humps, tips, ribs, pyramids.

4. The kit according to claim 3, wherein the energy directors project at least 10 μ

m beyond a shaft surface.

5. The kit according to claim 3, wherein the energy directors are arranged in a pattern.

6. The kit according to claim 1, wherein thermoplastic material is resorbable.

7. The kit according to claim 5, wherein the thermoplastic material comprises a polymer based on lactic acid.

8. The kit according to claim 1, wherein the plate consists of a plate thermoplastic plastic.

9. The kit according to claim 8, wherein the plate thermoplastic plastic is capable of being welded to the liquefiable thermoplastic material of the fastener implants.

10. The kit according to claim 1, wherein the through opening is countersunk.

11. The kit according to claim 1, wherein the plate is shaped so that the bone side surface follows a surface of the bone tissue.

12. The kit according to claim 1, wherein an outer shape of the fastener implant is stepped in a cross section, whereby the step forms one of the energy directors.

13. The kit according to claim 12, wherein the implant comprises a step-like reduction in cross section.

14. The kit according to claim 1, wherein an outer periphery of the fastener implant forms a step, the fastener implant comprising the thermoplastic material at the step.

15. The kit according to claim 14, wherein the step forms a right angle.

16. The kit according to claim 14, wherein the step points towards the distal end.

17. The kit according to claim 1, wherein a proximal end of the fastener implant is equipped for being coupled to an oscillating resonator.

18. The kit according to claim 17, comprising a holding means for cooperating with corresponding holding means on the resonator.

19. The kit according to claim 17, wherein the fastener implant comprises a proximally facing recess for coupling to the resonator.

20. The kit according to claim 1, wherein the proximal head and the stabilization plate are adapted to each other for the stabilization plate to be secured to the bone tissue by a positive-fit connection between the proximal head and the stabilization plate when the fastener implant is anchored in the bone tissue.

21. The kit according to claim 1, wherein the through opening is generally cylindrical, and wherein the proximal head form a distally facing abutment surface configured to rest against the surface opposite the bone side surface around a mouth of the opening.

22. The kit according to claim 1, wherein the through opening comprises a head receiving shape opening out towards the proximal side, wherein the head is shaped to be at least partially introduced into the head receiving portion.

23. The kit according to claim 22, wherein the fastener implant is capable of being driven into the opening so far as to be flush with the surface opposite the bone side surface.

27. The fastener implant according to claim 1, wherein an outer periphery of the fastener implant forms a step, the fastener implant comprising the thermoplastic material at the step.

28. The fastener implant according to claim 1, wherein a proximal end of the fastener implant is equipped for being coupled to an oscillating resonator.

29. The fastener implant according to claim 28, comprising a holding means for cooperating with corresponding holding means on the resonator.

30. The fastener implant according to claim 28 wherein the fastener implant comprises a proximally facing recess for coupling to the resonator.

24. An fastener implant for securing a fixation or stabilization plate plate to bone tissue for the purpose of fixing or stabilizing bone tissue,

wherein the fixation or stabilization plate comprises a bone side surface, a surface opposite the bone side surface and a plurality of through openings;

wherein fastener implant is generally pin-like, consists of a thermoplastic material liquefiable by mechanical oscillation, and comprises a distal shaft and a proximal head, wherein the shaft comprises energy directors for targeted liquefaction by concentration of oscillation energy;

wherein the shaft is capable of being advanced through a respective through opening of the plate, and wherein the fastener implants are equipped for being anchored by pressing the implant against the bone tissue with the shaft projecting through the through opening while impinging the implant with mechanical oscillation and without rotating the fastening implant until at least a part of the liquefiable material is liquefied and is pressed into structures of the bone tissue, and then letting the liquefiable material resolidify;

and wherein the head of the fastener implant is configured to secure the plate against the bone tissue when the shaft reaches through the opening and is anchored in the bone tissue.

25. The fastener implant according to claim 24 consisting of a resorbable thermoplastic material.

26. The fastener implant according to claim 24, wherein an outer shape of the fastener implant is stepped in a cross section, whereby the step forms one of the energy directors.