METHOD OF FASTENING A TISSUE OR A CORRESPONDING PROSTHETIC ELEMENT IN AN OPENING PROVIDED IN A HUMAN OR ANIMAL BONE AND FASTENER SUITABLE FOR THE METHOD

• US 20130006278A1
• Filed: 01/19/2011
• Published: 01/03/2013
• Est. Priority Date: 01/27/2010
• Status: Active Grant

• Current Assignee: SportWelding GmbH
• Original Assignee: SportWelding GmbH
• Inventors: Mayer, Jörg, Berra, Milica, Mueller, Andrea, Goebel-Mehl, Stephanie, Wenger, Andreas, Mock, Elmar
• Granted Patent: US 10,709,487 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8645 Headless screws, e.g. ligament interference screws
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins

Abstract

A graft or prosthetic element suitable e.g. for replacing a tendon or ligament is fastened in a bone tunnel or blind opening with the aid of a fastener. In a first step, the graft or prosthetic element is press-fitted in the tunnel or opening by forcing the fastener into the opening or by positioning the fastener in the opening and then expanding it, wherein the fastener is in contact with the graft or prosthetic element and with the bone wall of the tunnel or blind opening. In a second step, the fastener is anchored in the bone wall of the tunnel or blind opening with the aid of a liquefiable material which is liquefied in the vicinity of the bone wall where it is in contact with the fastener and by making the liquefied material penetrate into the bone wall.

Claims

1. A method for fastening tissue or a corresponding prosthetic element in an opening in a human or animal bone comprising the steps of:

providing a fastener and at least one anchoring element comprising a liquefiable material;

providing an opening in the human or animal bone, the opening comprising at least one mouth in a bone surface and an inside wall and being dimensioned for the fastener to fit into the opening;

for press-fitting the tissue or prosthetic element in the opening, positioning the tissue or prosthetic element in the opening and pressing it against a first portion of the inside wall by forcing the fastener into the opening or by expanding the fastener in the opening;

simultaneously transmitting energy to the liquefiable material of the anchoring element and advancing the anchoring element relative to the fastener, for liquefying at least part of the liquefiable material in the vicinity of a second portion different from the first portion of the inside wall and making it contact said second wall portion; and

letting the liquefied material to re-solidify in contact with the second wall portion.

2. The method according to claim 1, wherein the anchoring element is positioned relative to the fastener before or after the step of press-fitting or wherein the anchoring element is an integral part of the fastener.

3. The method according to claim 1, wherein, in the step of simultaneously transmitting and advancing, the liquefied material is made to penetrate into bone tissue of said second wall portion and/or into cavities provided in said second wall portion to form a positive-fit connection with said second wall portion on re-solidification.

4. The method according to claim 1, and further comprising a step of pre-treating at least said second wall portion by in situ liquefaction of a further liquefiable material and penetration of the bone tissue of said second wall portion and/or cavities provided in said second wall portion by the further liquefiable material, wherein, in the step of simultaneously transmitting and advancing, the liquefied material is welded to the further liquefied material.

5. The method according to claim 1, wherein the tissue to be fastened in the opening is a soft tissue graft or a prosthetic element suitable for replacing a natural soft tissue.

6. The method according to claim 5, wherein the soft tissue graft comprises at least one terminal bone block and/or at least one stitched end region.

7. The method according to claim 1, wherein the tissue to be fastened replaces an anterior cruciate ligament in a human knee joint and is fastened in a femoral and a tibial opening.

8. The method according to claim 1, wherein the opening has an elongated cross section and the soft tissue or prosthetic element to be fastened is a double strand graft.

9. The method according to claim 1, wherein the energy transmitted to the liquefiable material is mechanical vibration energy.

10. The method according to claim 1, wherein the liquefiable material is a material having thermoplastic properties.

11. A fastener suitable for fastening tissue or a prosthetic element in an opening provided in a human or animal bone, the fastener comprising:

a proximal face,

a distal end,

a fastener axis extending between the proximal face and the distal end and a circumferential surface extending around the fastener axis, and

the fastener further comprising at least one first portion of the circumferential surface and at least one second portion different from the first portion of the circumferential surface,

wherein the first portion is equipped for anchoring by comprising means for guiding a liquefiable material to the first portion or along the first portion, or by comprising the liquefiable material.

12. The fastener according to claim 11, wherein the first and second portions of the circumferential fastener surface are arranged as alternating first and second sectors around the fastener axis.

13. The fastener according to claim 12, wherein the means for guiding the liquefied material comprise at least one passage connecting an inner fastener cavity which is open at the proximal fastener face with the at least one first sector of the circumferential surface, comprises at least one channel extending at an angle to a fastener axis from the proximal fastener face to the at least one first sector of the circumferential surface, or comprises at least one groove extending from the proximal fastener face towards the distal end of the fastener.

14. The fastener according to claim 13, wherein the inner cavity is distally closed or comprises a narrower distal portion and distal mouth adapted to a guide wire.

15. The fastener according to claim 13, wherein an anchoring element is positioned in the inner cavity, in the at least one channel, or is integrated in the fastener in a central region.

16. The fastener according to claim 12, wherein the second sectors are flat or comprise a shallow groove for accommodating the soft tissue or prosthetic element or a strand thereof.

17. The fastener according to claim 12, wherein, for an extra-graft fixation, the fastener comprises one first and one second sector, or for an intra-graft fixation comprises a plurality of second sectors.

18. The fastener according to claim 11, further comprising a sleeve part and a spreader part, the spreader part being dimensioned to expand the sleeve part on being introduced therein.

19. A set comprising a fastener according to claim 11 and further comprising at least one anchoring element and an anchoring tool, wherein the anchoring element comprises a liquefiable material and the anchoring tool comprises a distal end adapted to the anchoring element and is capable of transmitting energy to the anchoring element and advancing the anchoring element relative to the fastener.

20. The set according to claim 19, wherein the at least one anchoring element is adapted to axially extending grooves in the circumferential surface of the fastener, to channels extending at an angle to the fastener axis from the proximal fastener face to the circumferential fastener surface, or to an inner cavity of the fastener or is integrated in a central or peripheral fastener region.

21. The set according to claim 19, wherein the anchoring element has a form of a pin or a tube.

22. The set according to claim 19, and further comprising an ultrasonic device comprising a sonotrode which constitutes the anchoring tool.

23. The set according to claim 19, and further comprising a guide tool, the guide tool comprising a distal end adapted in cross section to the proximal cross section of the fastener and further comprising a through channel adapted in cross section to a distal portion of the anchoring tool.

24. The set according to claim 23, the guide tool further comprising a through bore adapted to a guide wire.

25. The set according to claim 23, wherein the distal end of the guide tool is adapted to hold the fastener.