DEVICE AND METHOD FOR ESTABLISHING AN ANCHORAGE IN TISSUE

• US 20110118744A1
• Filed: 04/30/2009
• Published: 05/19/2011
• Est. Priority Date: 05/01/2008
• Status: Active Grant

• Current Assignee: Woodwelding AG
• Original Assignee: Woodwelding AG
• Inventors: Weber, Urs, Seiler, Philipp, Lehmann, Mario, Mueller, Andrea
• Granted Patent: US 9,226,784 B2
• Time in Patent Office: Days
• US Class Current: 606/104
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/809 with bone-penetrating elements, e.g. blades or prongs bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/90 Guides therefor
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/8813 Discharging means for excessively introduced fluid fillers, e.g. discharging excess cement
• CPC Class Codes: A61B 2017/883 Means for indicating hardening of bone cement
• 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 2210/0071 : thermoplastic

Abstract

A perforated sheath is anchored in a tissue opening with the aid of a tool, wherein the anchorage is achieved with the aid of mechanical vibration and a material which is liquefiable by the vibration. The tool includes a vibrating element and a counter element. Distal portions of both elements are introduced into the sheath to be in contact with each other at an interface. The vibrating element is connected to a vibration source and the vibrating element and the counter element are held against each other for effecting liquefaction of the liquefiable material at the interface. Under the effect of the force applied to the vibrating and counter element for holding them against each other, the liquefied material flows from the interface through the sheath perforation and penetrates the tissue.

Claims

1. A device for establishing an anchorage in tissue with the aid of a material having thermoplastic properties, the device comprising:

a perforated sheath having a sheath axis, and an inner cross section and an outer cross section, and

a tool comprising an active element and a counter element, the active element having a proximal end suitable for being connected to an energy source and being capable of transmitting energy generated by the energy source to a distal portion of the active element,

wherein a distal portion of the active element and a distal portion of the counter element have a cross section being adapted to the inner cross section of the sheath to allow introduction of these distal portions into the sheath, positioning of these distal portions axially beside each other and in contact with each other within the sheath, and movement of these distal portions in an axial direction within the sheath,

wherein the distal portion of one of the active element and the counter element comprises an axial passage and the other one comprises a proximal shaft portion adapted to the passage for axial movement therein, and

wherein the material having thermoplastic properties is provided on one of the active element and the counter element at an interface where the elements are in contact with each other.

2. The device according to claim 1, wherein the material having thermoplastic properties is liquefiable by mechanical vibration, wherein the energy source is a vibration source, and wherein the active element is a vibrating element.

3. The device according to claim 2, wherein the vibrating element comprises a foot piece and a shaft, the foot piece being connected to a distal end of the shaft and a proximal end of the shaft being equipped to be coupled to a vibration source, and wherein the counter element is tube shaped, the shaft of the vibrating element extending through the counter element.

4. The device according to claim 3, wherein the counter element comprises a liquefiable part and a counter acting part the liquefiable part consisting of the liquefiable material and being arranged between the foot piece of the vibrating element and the counter acting part.

5. The device according to claim 3, wherein at least one of the connection between the foot piece and the shaft and of the coupling between the shaft and the vibration source is reversible.

6. The device according to claim 3, wherein the counter element or a liquefiable part thereof comprises a plurality of tubes or beads or a plurality of axially slotted tubes or beads.

25. The device according to claim 1, wherein the sheath perforations are defined through openings or are constituted by porous wall sections.

26. The device according to claim 25, wherein the sheath is a cannulated screw.

27. The device according to claim 25, wherein the sheath has the form of a tube and the perforations are provided on one tube side only.

28. The device according to any one of claims 25, wherein the sheath comprises more than one inner space.

29. The device according to claim 28, wherein the sheath is an element suitable for being introduced in an intervertebral space.

30. The device according to claim 1, wherein the liquefiable material is a material having thermoplastic properties, a modulus of elasticity of at least 0.5 GPa and a melting temperature of at the most 350°

C.

7. A method for establishing an anchorage in tissue with the aid of mechanical vibration and a material which is liquefiable by mechanical vibration, the method comprising the steps of:

providing an opening in the tissue,

providing a perforated sheath adapted to the tissue opening and having a sheath axis, and an inner cross section and an outer cross section,

comprising a vibrating element having a proximal end suitable for being connected to a vibration source and being capable of transmitting vibration generated by the vibration source to a distal portion of the vibrating element, and a counter element, wherein a distal portion of the vibrating element and a distal portion of the counter element have a cross section being adapted to the inner cross section of the sheath to allow introduction of these distal portions into the sheath, positioning of these distal portions axially beside each other and in contact with each other within the sheath and movement of these distal portions in an axial direction within the sheath, wherein the distal portion of one of the vibrating element and the counter element comprises an axial passage and the other one comprises a proximal shaft portion adapted to the passage for axial movement therein, and wherein the liquefiable material is provided on one of the vibrating element and the counter element at an interface where they are in contact with each other,

positioning the sheath in the tissue opening,

connecting a proximal end of the vibrating element to a vibration source and positioning a distal end of the tool into the sheath with the interface between the vibrating element and the counter element situated in the region of a sheath perforation,

holding the counter element against the vibrating element by applying opposite forces to the counter element and the vibrating element and transmitting mechanical vibration to the distal end of the vibrating element for a time sufficient to liquefy part of the liquefiable material at the interface between the vibrating element and the counter element and to make the liquefied material flow from the interface through the sheath perforation to penetrate the tissue and/or a pace between the tissue and the sheath, and

removing the tool from the sheath.

8. The method according to claim 7, wherein for keeping the inner space of the sheath substantially free of the liquefiable material, the cross section of the distal end of the tool is substantially the same as the inner cross section of the sheath.

9. The method according to claim 7, wherein for creating a layer of the liquefiable material in the sheath, the cross section of the distal end of the tool is smaller than the inner cross section of the sheath.

10. The method according to claim 7, wherein, before the step of removing, the distal end of the tool is axially displaced within the sheath for positioning the interface at a further anchoring location where a further anchorage is established.

11. The method according to claim 7, wherein, in the step of holding and transmitting, the interface is kept at a stationary position relative to the sheath.

12. The method according to claim 7, wherein, after the step of removing, the tool is furnished with further or new liquefiable material.

31. The method according to claim 7, wherein the mechanical vibration has a frequency of between 2 and 200 kHz.

13. A method for dispensing, in a liquefied state, a material, which has thermoplastic properties and which is liquefiable by mechanical vibration, at an operating site, the method comprising the steps of:

providing a tool comprising an active element having a proximal end suitable for being connected to an energy source and being capable of transmitting energy generated by the energy source to a distal portion of the active element, and a counter element, wherein the distal portion of one of the active element and the counter element comprises an axial passage and the other one comprises a proximal shaft portion adapted to the passage for axial movement therein, and wherein the liquefiable material is provided on one of the active element and the counter element at an interface where they are in contact with each other,

connecting a proximal end of the active element to an energy source and positioning a distal end of the tool in the operating site with the interface between the active element and the counter element situated in a region where dispensing of the liquefiable material is desired,

holding the counter element against the active element by applying opposite forces to the counter element and the active element and transmitting energy of the energy source to the distal end of the active element for a time sufficient to liquefy a desired amount of the liquefiable material at the interface between the active element and the counter element and to make the liquefied material flow from the interface, and

removing the tool from the operating site.

14. The method according to claim 13, wherein the material having thermoplastic properties is liquefiable by mechanical vibration, the energy source is a vibration source and the active element is a vibrating element.

15. A device for establishing an anchorage in tissue with the aid of mechanical vibration and a material having thermoplastic properties and being liquefiable by the mechanical vibration, the device comprising:

a vibrating element, comprising a distal portion of a smaller cross section, a proximal portion of a larger cross section and a shoulder therebetween, a proximal end of the vibrating element being suitable for being coupled to a vibration source and the vibrating element being capable of transmitting vibration generated by the vibration source to a distal end of the vibrating element, and

a tube-shaped liquefiable part comprising the liquefiable material and having an inner cross section and an outer cross section,

wherein the distal portion of the vibrating element is dimensioned for extending into the tube-shaped liquefiable part, and wherein the liquefiable part is fixed to the distal portion of the vibrating element or sits thereon.

16. The device according to claim 15, and further comprising a perforated sheath comprising an inner sheath space of which at least an outer region has a cross section adapted to the outer cross section of the liquefiable part.

17. The device according to claim 16, wherein the inner sheath space comprises in addition to the outer region an inner region of a cross section which is smaller than the cross section of the outer region, and a step between the two regions, wherein the cross section of the inner region is adapted to the cross section of the distal portion of the vibrating element, and wherein perforations are arranged in the region of the step.

18. The device according to claim 15, wherein the tube-shaped liquefiable part is fixed to the distal portion of the vibrating element and is biased against the shoulder thereof.

19. The device according to claim 16, wherein an axial length of the distal portion of the vibrating element is at least as great as a difference between an axial length of the inner space of the sheath and an axial length of the liquefiable part.

20. The device according to claim 15, wherein the shoulder is constituted by a thread reaching at least partly into the liquefiable part.

21. The device according to claim 15, wherein the distal portion of the vibrating element is replaced by a separate guide element and an axial recess in the vibrating element, which recess is able to accommodate a proximal portion of the guide element.

22. A method for establishing an anchorage in tissue with the aid of mechanical vibration and a material which is liquefiable by the mechanical vibration, the method comprising the steps of:

providing a device comprising a vibrating element and a tube-shaped liquefiable part, wherein the vibrating element comprises a distal portion of a smaller cross section, a proximal part of a larger cross section and a shoulder therebetween, a proximal end of the vibrating element being suitable for being coupled to a vibration source, and the vibrating element being capable of transmitting vibration generated by the vibration source to a distal end of the vibrating element, wherein the tube-shaped liquefiable part comprises the liquefiable material and has an inner cross section and an outer cross section, wherein the distal portion of the vibrating element is dimensioned for extending into the tube-shaped liquefiable part, and wherein the distal portion of the vibrating element reaches into the tube-shaped liquefiable part, which is fixed on the latter or sits thereon,

coupling the device to the vibration source,

providing a perforated sheath with an inner sheath space of which at least an outer region has a cross section adapted to the outer cross section of the liquefiable part,

providing a tissue opening,

positioning the perforated sheath into the tissue opening such that outer mouths of the perforations are close to tissue walls of the tissue opening,

positioning a distal portion of the device in the inner sheath space such that a distal face of the liquefiable part sits on a bottom or on a step of the inner sheath space,

switching on the vibration source and pressing the device against the step of the inner sheath space for a time sufficient for liquefying at least a part of the liquefiable material and making it flow through the perforations of the sheath and penetrate into the tissue,

switching off the vibration source and removing the vibrating element from the liquefiable part and the sheath.

24. The method according to claim 22, wherein an axial length of the distal portion of the vibrating element is at least as great as a difference between an axial length of the liquefiable part and a depth of the outer portion of the inner sheath space or the tissue opening.

23. A method for establishing an anchorage in tissue with the aid of mechanical vibration and a material which is liquefiable by the mechanical vibration, the method comprising the steps of:

providing a device comprising a vibrating element and a tube-shaped liquefiable part, wherein the vibrating element comprises a distal portion of a smaller cross section, a proximal portion of a larger cross section and a shoulder therebetween, a proximal end of the vibrating element being suitable for being coupled to a vibration source, and the vibrating element being capable of transmitting vibration generated by the vibration source to a distal end of the viobrating element, wherein the tube-shaped liquefiable part comprises the liquefiable material and has an inner cross section and an outer cross section, wherein the distal portion of the vibrating element is dimensioned for extending into the tube-shaped liquefiable part, and wherein the distal portion of the vibrating element reaches into the tube-shaped liquefiable part, which is fixed on the latter or sits thereon,

coupling the device to the vibration source,

providing a tissue opening of which at least on outer portion has a cross section which is adapted to the outer cross section of the liquefiable part,

positioning a distal portion of the device in the tissue opening such that a distal face of the liquefiable part sits on a bottom or on a step of the tissue opening,

switching on the vibration source and pressing the device against the step of the tissue opening for a time sufficient for liquefying at least a part of the liquefiable material and making it penetrate into the tissue,

switching off the vibration source and removing the vibrating element from the liquefiable part and the tissue.